UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON,
DC 20549
FORM 20-F
(Mark
One)
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REGISTRATION STATEMENT PURSUANT TO
SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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OR
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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2007
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OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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OR
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Commission
File Number: 0-17434
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DRAXIS
HEALTH INC.
(Exact
name of Registrant as specified in its charter)
CANADA
(Jurisdiction of incorporation
or organization)
SUITE
4700, TD BANK TOWER, TORONTO DOMINION CENTRE, TORONTO, ONTARIO,
CANADA M5K 1E6
(Address
of principal executive offices)
Securities registered or to be registered pursuant to Section 12(b) of
the Act.
Title of
each class
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Name of
each exchange on which registered
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COMMON
SHARES
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NASDAQ
Global Select Market
Toronto
Stock Exchange
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Securities registered or to be registered pursuant to Section 12(g) of
the Act.
NONE
(Title of Class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of
the Act.
NONE
(Title of Class)
Indicate the number of outstanding shares of each of the issuers
classes of capital or common stock as of the close of the period covered by the
annual report.
Shares 42,062,538 common shares (as of 12/31/07)
Indicate by check mark if the registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities Act.
Yes
o
No
x
If this report is an annual or transition report, indicate by check mark
if the registrant is not required to file reports pursuant to Section 13
or 15(d) of the Securities Exchange Act of 1934.
Yes
o
No
x
Note Checking the box above will not relieve any registrant required
to file reports pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the Registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period
that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes
x
No
o
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and
large accelerated filer in Rule 12b-2 of the Exchange Act. (Check one)
Large accelerated filer
o
Accelerated filer
x
Non-accelerated filer
o
Indicate by check mark which financial statement item the Registrant has
elected to follow.
Item 17
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Item 18
x
If this is an annual report, indicate by check mark whether the
registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes
o
No
x
Item 1. Identity of Directors, Senior Management and Advisers
Not Applicable
Item 2. Offer Statistics and Expected Timetable
Not Applicable
Item 3. Key Information
Selected Consolidated
Financial Data
DRAXIS Health Inc. (DRAXIS or the Company) is a specialty
pharmaceutical company providing products in three categories: sterile
products, non-sterile products and radiopharmaceuticals. Sterile products include liquid and
freeze-dried (lyophilized) injectables and sterile ointments. Non-sterile products are produced as solid
oral, liquid and semi-solid dosage forms.
Radiopharmaceuticals are used for both therapeutic and diagnostic
molecular imaging applications. In the radiopharmaceutical
category, DRAXIS has its own products and a targeted research and development
program for new products. As of January 1,
2005, all of the operations of the Company are carried out through our wholly
owned subsidiary DRAXIS Specialty Pharmaceuticals Inc. (DSPI), which operates
two major divisions, DRAXIS Pharma (contract manufacturing) and DRAXIMAGE
(radiopharmaceuticals). Our operations
are carried out at our sole manufacturing facilities located at 16751,
Trans-Canada Highway, Kirkland, Québec,
H9H 4J4
, Canada (our manufacturing
facilities or facility). For the year
ended December 31, 2007, 69.7% of our consolidated revenues were derived
from DRAXIS Pharma (contract manufacturing) and 29.4% of our consolidated
revenues were derived from DRAXIMAGE (radiopharmaceuticals).
Our subsidiary Deprenyl Animal Health, Inc. (DAHI) receives
licensing and royalty revenue related solely to
ANIPRYL
®
, a companion
animal health product. It does not
engage in any operations.
Our registered office is located at Suite 4700, TD Bank Tower,
Toronto Dominion Centre, Toronto, Ontario, M5K 1E6, Canada. The phone number
for the registered office is 416-601-7525.
We also have a place of business at 16751 Trans-Canada Highway,
Kirkland, Québec, H9H 4J4 where all of our operations are conducted. The phone
number for this place of business is 514-694-8220. DRAXIS is a corporation
governed by the
Canada Business Corporations
Act
(the CBCA or the Act)
Unless otherwise indicated herein, the information presented in this
Annual Report (Form 20-F) is for the year ended December 31,
2007. All amounts expressed herein are
in U.S. dollars unless specifically stated otherwise.
The selected consolidated income statement data for the years ended December 31,
2005, 2006 and 2007, and the selected consolidated balance sheet data as of December 31,
2006 and 2007, are derived from the audited Consolidated Financial Statements
included elsewhere in this Annual Report (Form 20-F). The selected consolidated income statement
data for the years ended December 31, 2003 and 2004, and selected consolidated
balance sheet data as of December 31, 2003, 2004 and 2005 are derived from
our audited consolidated financial statements which are not included in this
Annual Report (Form 20-F). The
selected financial data set forth in the following table are presented in
accordance with U.S. generally accepted accounting principles (U.S.
GAAP). All data presented below should
be read in conjunction with, and is qualified in its entirety by, reference to
our audited Consolidated Financial Statements and Notes thereto for the year
ended December 31, 2007 which are included in this Annual Report (Form 20-F).
1
Selected Five-Year Review
(in
thousands of U.S. dollars except share related data)
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2007
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2006
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2005
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2004
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2003
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Operations
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Revenues
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Product sales
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76,072
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83,545
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72,989
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61,693
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40,535
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Royalty and licensing
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2,788
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5,422
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6,444
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7,627
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8,658
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78,860
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88,967
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79,433
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69,320
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49,193
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Operating income
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2,148
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14,952
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9,764
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9,856
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6,686
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Income from
continuing operations
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1,658
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11,547
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7,784
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7,977
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4,671
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(Loss) income
from discontinued operations, net of tax
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(61
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8,531
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Net income
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1,658
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11,547
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7,784
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7,916
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13,202
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Basic earnings
per share
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- From continuing operations
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$
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0.04
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$
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0.28
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$
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0.19
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$
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0.20
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$
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0.13
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- From discontinued operations
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0.23
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$
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0.04
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$
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0.28
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$
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0.19
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$
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0.20
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$
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0.36
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Diluted earnings
per share
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- From continuing operations
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$
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0.04
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$
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0.28
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$
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0.18
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$
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0.19
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$
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0.13
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- From discontinued operations
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0.23
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$
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0.04
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$
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0.28
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$
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0.18
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$
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0.19
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$
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0.36
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Financial
Position at December 31
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Cash and cash
equivalents
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24,796
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21,446
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12,390
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5,926
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10,563
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Total assets
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127,934
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105,962
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95,820
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88,785
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76,553
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Long-term debt
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10,466
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Common
shareholders equity
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111,341
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92,415
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81,628
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69,920
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41,647
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Book value per
common share
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2.65
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2.23
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1.96
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1.70
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1.12
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Share
Information
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Number of shares
outstanding at end of year
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42,062,538
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41,522,138
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41,588,005
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41,015,326
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37,297,817
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Weighted average
number of shares - basic
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41,955,989
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41,592,507
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41,471,798
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39,886,219
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37,114,648
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Weighted average
number of shares - diluted
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42,096,250
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41,675,682
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42,365,782
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41,054,883
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37,194,994
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Forward-Looking Statements
This Annual Report (Form 20-F) contains forward-looking statements
(within the meaning of the Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended) and information that are based on managements beliefs, as well as
assumptions made by and information currently available to management. When used in this Annual Report (Form 20-F),
the words anticipate, estimate, forecast, plan, believe, expect,
potential, intend, projected, designed, should and similar
expressions are intended to identify forward-looking statements, but they are
not the only way we identify such statements.
These forward-looking statements necessarily make numerous assumptions
with respect to: industry performance; general business, economic and
regulatory conditions; access to markets and materials; and other matters, all
of which are inherently subject to significant uncertainties and contingencies
and many of which are beyond our control.
Should one or more of these risks or uncertainties materialize, or
should underlying assumptions made or factors considered in making a
forward-looking statement prove incorrect, actual results may vary materially
from those anticipated, estimated or projected.
We believe that any of the following risk factors could cause our actual
results to differ from those that may have been or may be projected in
2
forward-looking statements
made by us or on our behalf from time to time. We caution you that the
following list of risk factors is not exclusive and that other risks and
uncertainties may cause actual results to differ materially from those in
forward-looking statements. The forward-looking statements in this Annual
Report (Form 20-F) are principally contained under Items 4 and 5.
RISK
FACTORS
Our future
financial condition, results of operations and business could be materially
affected by the risks and uncertainties discussed below, or otherwise, and
historic trends should not be used to anticipate results or trends in future
periods:
Risks Related to our Industry
WE MAY NOT BE
ABLE TO GET TIMELY REGULATORY APPROVAL FOR OUR PRODUCTS AND WE MUST COMPLY WITH
REGULATORY REQUIREMENTS TO MANUFACTURE AND MARKET OUR PRODUCTS.
The manufacturing
and marketing of our existing and potential products, as well as preclinical
studies and clinical trials, are subject to extensive regulation and approval
by the Therapeutic Products Directorate (TPD) of the Health Products and Food
Branch Inspectorate of Health Canada (HPFBI) and other authorities in Canada
and by numerous federal, state and local government authorities in the United
States, including the Food and Drug Administration (FDA). Similar regulatory
requirements exist in Europe and other countries. To the extent we choose to distribute our
products in foreign markets, we may rely on licensees to obtain regulatory
approvals in such countries. Any failure
or delay by us, our collaborators or licensees to comply with applicable
requirements or obtain regulatory approvals for our products could adversely
affect the marketing of products developed or licensed by us and our ability to
receive product or royalty revenue.
As of December 31,
2007, DRAXIMAGE had six regulatory submissions filed with European regulatory
authorities: four with the Medicines Evaluation Board in the Netherlands, one
with the Danish Medicines Agency, and one in Denmark under the decentralized
procedure. The submission dates for the
radiopharmaceutical products filed in the Netherlands and with the Danish
Medicine Agency range from June 2003 to December 2004 (except for one
regulatory submission re-filed in Denmark in 2007 for rewording). All of the
approvals, except for the most recent submission, sought by DRAXIMAGE in Europe
are for marketing authorizations through the mutual recognition procedure,
which involves obtaining approval in one state (the reference member state)
and recognition of that approval in other member states. Five of the approvals being sought by
DRAXIMAGE in Europe are for radiopharmaceutical products already approved in
Canada or the U.S. The most recent submission is for DRAXIMAGE
Ò
Sestamibi which has not yet received approval in Canada or the U.S. Two
of these six European submissions, made for DRAXIMAGE MAA kit and MDP kit,
received approval in a reference member state, the Netherlands, in February 2005
and March 2006. The MDP kit also
received approval in the United Kingdom in February 2008. The MAA kit has
also been approved in Germany, the United Kingdom, Austria, Belgium and
Luxembourg. A third approval for
DRAXIMAGEs Sodium Iodide I-131 capsules was granted in reference member state,
Denmark, in September 2007.
The regulatory
process for innovative products generally involves preclinical studies and
clinical trials of each compound to establish its safety and efficacy, takes many
years and requires the expenditure of substantial resources. For generic products, the regulatory process
does not typically involve clinical studies.
Moreover, if regulatory approval of a drug or diagnostic product is
granted, such approval may entail limitations on the indicated uses for which
it may be marketed. Our failure to
comply with applicable regulatory requirements can, among other things, result
in the suspension of our regulatory
3
approvals, product recalls, seizure of products, operating restrictions
and criminal prosecution. Further,
government policy may change and additional government regulations may be
established that could prevent or delay regulatory approvals for our products. In addition, a marketed drug and its
manufacturer are subject to continual review.
Later discovery of previously unknown problems with the product or
manufacturer may result in restrictions on such product or manufacturer,
including withdrawal of the product from the market.
On February 2,
2007, DRAXIMAGE announced it had submitted an Abbreviated New Drug Application
(ANDA) to the FDA for its generic kit for the preparation of Tc-99m Sestamibi
for injection (DRAXIMAGE
Ò
Sestamibi), a nuclear medicine imaging
agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to
the heart in patients undergoing cardiac tests.
On July 25, 2007, DRAXIMAGE announced it had filed DRAXIMAGE
Ò
Sestamibi with European regulatory authorities.
The Company also filed an Abbreviated New Drug Submission (A/NDS) for
DRAXIMAGE
Ò
Sestamibi on August 17, 2007 with
Health Canada. On October 11, 2007,
the Company was informed by Health Canada that this submission had been
screened and found acceptable for review.
We cannot predict if or when we will receive regulatory approvals to
market this product.
The final
products in which active pharmaceutical ingredients are used are subject to
regulation for safety and efficacy by the FDA, TPD and regulatory authorities in
other jurisdictions, as the case may be.
All of the final products that DRAXIMAGE or DRAXIS Pharma manufacture
must be approved by the FDA, TPD and the regulatory authorities in other
jurisdictions, as the case may be, before they can be commercially marketed. The process of obtaining regulatory clearance
for marketing is uncertain, can be costly and time-consuming. We cannot predict how long the necessary
regulatory approvals will take or whether we or our customers for whom we
manufacture products will ever obtain such approval for products. To the extent that we and/or our customers do
not obtain the necessary regulatory approvals for marketing new products, our
product sales could be adversely affected.
All products
manufactured by us (including those manufactured for our contract manufacturing
customers) have to comply with the current Good Manufacturing Practices
(cGMP) imposed under the laws of the U.S., Canada and other jurisdictions, as
well as the guidelines and policies of TPD, FDA and the regulatory authorities
in other jurisdictions, as the case may be.
In addition, products containing radioactive isotopes will have to
comply with the guidelines and regulations of the Canadian Nuclear Safety
Commission in Canada and the United States Nuclear Regulatory Commission and
other similar regulations in other countries.
Compliance with cGMP regulations
requires us to expend time, money and effort on our production facilities and
to maintain precise and extensive records and quality control to ensure that
our products meet applicable specifications and other requirements. The FDA,
TPD and other regulators may periodically inspect our drug manufacturing
facilities to ensure compliance with applicable cGMP requirements. In 2007, the
Company announced it had received a notification from the FDA that its
manufacturing facilities continue to maintain their classification as
acceptable facilities following an extensive inspection by the FDA in January 2007
of all six products and quality systems for the contract manufacturing
division. There can be no assurance that
subsequent inspections will have similar results. In addition, our customers
also periodically inspect our manufacturing facilities to ascertain compliance
with cGMP requirements. If we fail to
comply with the cGMP requirements, we may become subject to possible regulatory
action, and manufacturing at the facility could consequently be suspended,
causing possible loss of profit, regulatory fines and third-party liability. To date we have not been subject to any
notice of material non-compliance.
The FDA, TPD or
other regulatory authorities may also require us to submit specific batches or
lots of a particular product for inspection. If the product lot fails to meet
applicable requirements, then the following actions might be taken: (i) restrict
the release of the product; (ii) suspend manufacturing of the specific
product lot; (iii) order a recall of the product lot; or (iv) order a
seizure of the product lot.
4
WE MAY NOT BE ABLE TO OBTAIN AND ENFORCE
EFFECTIVE PATENTS TO PROTECT OUR PROPRIETARY RIGHTS FROM USE BY COMPETITORS,
AND THE PATENTS OF OTHER PARTIES COULD REQUIRE US TO STOP USING OR TO ACQUIRE A
LICENSE FOR CONDUCTING CERTAIN BUSINESS ACTIVITIES, AND OUR COMPETITIVE
POSITION AND PROFITABILITY COULD SUFFER AS A RESULT.
Our success
depends, in part, on our ability to obtain, enforce and maintain patent
protection for our radiopharmaceutical technologies. Patents for our radiopharmaceutical
technologies have expiry dates ranging from November 2008 to December 2020. We cannot assure you that patents will be
issued from any of our pending applications or that claims now or in the
future, if any, allowed under issued patents will be sufficiently broad to
protect our technology. In addition, we cannot assure you that any patents
issued to or licensed by us will not be challenged, invalidated, infringed or
circumvented, or that the rights granted under these patents will provide
continuing competitive advantages to us.
The patent positions of pharmaceutical and biotechnology firms,
including ours, are generally uncertain and involve complex legal and factual
questions. In addition, we do not know
whether any of our current research endeavors will result in the issuance of
patents in Canada, the United States or elsewhere, or if any patents already
issued will provide significant proprietary protection or will be circumvented
or invalidated. Since patent
applications in the United States and Canada are maintained in secrecy for at
least 18 months from the date of filing, and since publication of discoveries
in the scientific or patent literature tends to lag behind actual discoveries
by several months, we cannot be certain that we will be the first to create
inventions claimed by pending patent applications or that we will be the first
to file patent applications for such inventions. Our failure to obtain patents for our
products could negatively affect our competitive position.
Our commercial
success also depends in part on our not infringing patents or proprietary
rights of others and not breaching the licenses granted to us. In the event that we are found to have
infringed other parties patents, licenses may not be available to us on terms
that are commercially favorable or at all.
In addition, the degree of patent protection afforded to pharmaceutical
or biotechnological inventions around the world is uncertain and varies
significantly among different countries.
We cannot assure you that we will be able to license third-party
technology or patents that we may require to conduct our business or that such
technology or patents can be licensed at a reasonable cost. Failure by us or
our collaborators or customers to license any technology or patents that we may
need to commercialize our technologies or manufacture our products may result
in delays in marketing our products or may impede our inability to proceed with
the development, manufacture or sale of products requiring such licenses. There can be no assurance that any of our
products currently in development or our recently approved products will
achieve market acceptance.
We may be required
to engage in litigation and other patent proceedings to enforce patents issued
to us, to defend our right, title and interest in patents related to our
products and to determine the scope and validity of other parties proprietary
rights. These proceedings can be costly,
and if the outcome of any such proceedings is adverse to us, we could lose the right
to sell some of our products or could be required to pay damages, which may be
substantial.
We also rely on
unpatented trade secrets, improvements and know-how with respect to our
contract manufacturing operations and all of our operations associated with our
radiopharmaceutical kit business to develop and maintain our competitive
position, which we seek to protect, in part, by confidentiality agreements with
our customers, collaborators, employees and consultants. These agreements could be breached, and we
may not have adequate remedies for any breach. Further, our trade secrets could
otherwise become known or be independently discovered by our competitors.
ALTHOUGH WE CARRY
PRODUCT LIABILITY INSURANCE, A SUCCESSFUL
5
LIABILITY CLAIM
COULD NEGATIVELY IMPACT OUR BUSINESS.
We may be
subject to liability claims by those who purchase our contract manufacturing
services, for the use of any of our products under clinical development and the
sale and use of any of our approved products.
Such claims may be made directly by customers, consumers, healthcare
providers, pharmaceutical companies or others selling such products. Although we believe that our insurance
coverage is reasonably adequate to insulate us from potential product liability
claims and we have not historically experienced any problems associated with
claims by those who purchase our contract manufacturing services or users of
our products under clinical development or the radiopharmaceutical products
that we manufacture, we cannot provide any assurance that we will be able to
maintain insurance coverage at a reasonable cost or in sufficient amounts to
protect us against losses due to this potential liability. We may not be able to maintain or obtain
additional commercially reasonable product liability insurance for any of our
products approved for marketing and sale.
Even unsuccessful product liability claims could result in the
expenditure of funds in litigation and the diversion of management time and
resources and could damage our reputation and impair the marketability of our
products, which could have a material adverse effect on our financial condition
and results of operation.
On July 22,
2005, we announced that, together with other defendants, we had received a
Statement of Claim filed before the Superior Court of Justice of Ontario
alleging that Permax
Ò
, a drug that we distributed in Canada for a third party manufacturer
prior to July 2003, causes compulsive/obsessive behaviour, including
pathological gambling. The plaintiff is
seeking to have this action certified as a class action. We believe this claim against us is without
merit and we intend to vigorously defend this proceeding and any motion for
certification. Prior to July 2003,
Permax
Ò
was distributed
in Canada by DRAXIS Pharmaceutica, our Canadian pharmaceutical sales and
marketing division. In July 2003,
we sold the DRAXIS Pharmaceutica division to Shire BioChem Inc. (Shire).
On February 29, 2008, the plaintiff served an
Amended Statement of Claim and a Motion Record in support of the plaintiffs
motion for certification of this action as a class proceeding. The defendants must file a response to
plaintiffs motion for certification by July 31, 2008.
IF THE MARKET DOES
NOT ACCEPT OUR PRODUCTS CURRENTLY IN DEVELOPMENT OR AWAITING APPROVAL, OUR
BUSINESS COULD BE HARMED.
There can be no
assurance that any of our products currently in development, or those awaiting
approval or our recently approved products will achieve market acceptance. The degree of market acceptance will depend
upon a number of factors, including the receipt of regulatory approvals
(generic and innovative products), the establishment and demonstration in the
medical community of the clinical efficacy and safety of our products
(innovative products), the establishment and demonstration of their potential
advantages to existing and new diagnostic and treatment methods and the
reimbursement policies of government and third-party payers and, most
importantly, the launching of competing products by our competitors that become
established prior to the launch of our products in development. There can be no
assurance that physicians, patients, payers or the medical community in general
will accept and utilize any of our existing or future products.
We
anticipate that we will face increased competition in the future as new
products enter the market, as we enter new markets with generic and potentially
proprietary products and advanced technologies become available. There can be no assurance that existing
products or new products developed by our competitors will not be more
effective, or be more effectively marketed and sold, than any of the products
that may be developed, manufactured or sold by us. Competitive products may render our products
obsolete and uncompetitive prior to recovering our research, development or
commercialization expenses incurred with respect to any such products.
6
We may
lose market exclusivity for one or more of our proprietary products due to
generic challenges. This is because the
introduction of a generic version of the same or similar products typically
results in a significant reduction in net sales for the relevant product, given
that generic manufacturers typically offer their versions of the same product
at sharply lower prices.
For
example, in a press release dated November 1, 2007, we announced that the
Company was ceasing all further activities related to its product
INFECTON
Ò
and redeploying its
development teams to other projects following the results of additional
formulations for the product which indicated that sufficient specifity and
sensitivity could be achieved in a cost effective manner which would be
commercially important. In another press
release dated March 27, 2006, we announced that although our product
FIBRIMAGE
Ò
had met primary end points in
its Phase III clinical trial in Canada, further market analysis had shown that
new technologies had successfully captured the current deep venous thrombosis
indications and there was no longer an economically interesting market
opportunity at this time in either the at-risk asymptomatic patient, or those
with symptoms. We further indicated that
we had decided that no significant further work would be conducted in the
development of this product for its current indications but that other
potential opportunities for this product would be explored. In 2006 and 2007, no other potential
opportunities were uncovered.
We
believe that AZEDRA
Ô
, being developed by Molecular
Insight Pharmaceuticals, Inc. (MIPI) may compete with our DRAXIMAGE
Ò
I-131 MIBG product under clinical
development. AZEDRA
Ô
has received Orphan Drug status and a Fast
Track designation by the FDA. According
to information set forth in its website, MIPI is conducting a Phase I dosimetry
study with AZEDRA
Ô
in adults at Duke
University. The initial target market
for AZEDRA
Ô
dosimetry study is the
treatment of metastatic neuroendocrine tumours such as pheochromocytoma, carcinoid
and neuroblastoma that are not amenable to treatment with surgery or
conventional chemotherapy. Metastatic
tumours are tumours that spread to other organs or parts of the body. Additionally, according to information set
forth in its website, MIPI initiated a Phase I/II study dose-finding and
therapeutic evaluation of the product in patients with malignant
Pheochromocytoma/Paraganglioma, which completion is expected for July 2012.
The primary objectives of this study are to determine the maximum tolerated
dose of the product and then, to determine the objective tumor response rate
nine months following treatment.
On February 27, 2008,
Covidien announced it had received tentative approval from the FDA for its
generic Sestamibi. This product will
compete with our DRAXIMAGE
Ò
Sestamibi product for
which we filed an ANDA with the FDA in February 2007 and for which we have
not yet received an approval. Failure to
receive this approval could have a material negative impact on the expected
future results of our operations.
WE DO NOT
HAVE THE SAME AMOUNT OF RESOURCES AS SOME OF OUR COMPETITORS.
Many of our
existing or potential competitors, particularly large pharmaceutical companies,
have substantially greater financial, technical and human resources than we do.
In addition, many of these competitors have significantly greater experience in
undertaking research, preclinical studies and human clinical trials of new
pharmaceutical products, including innovative and generic products, obtaining
regulatory approvals, manufacturing and marketing such products. Accordingly, our competitors may succeed in
commercializing or manufacturing products more rapidly or effectively than we
can.
WE OPERATE IN A VERY COMPETITIVE MARKET.
DRAXIS Pharma, our contract manufacturing division, competes with
pharmaceutical companies that have in-house manufacturing capabilities as well
as with third-party contract manufacturers,
7
including Hospira Inc., Boehringer Ingelheim GmbH, Catalent Pharma
Solutions Inc., DPT Laboratories Ltd, Haupt Pharma AG, Patheon Inc.,
Hollister-Stier Laboratories LLC and DSM Pharmaceuticals, Inc.
DRAXIMAGE, our
radiopharmaceuticals division, competes with the following companies that have
significant radiopharmaceutical operations: Lantheus Medical Imaging (formerly
Bristol-Myers Squibb Imaging), GE Healthcare, Covidien, CISbio, and Bracco
S.p.A. In addition, there are a number
of companies that are developing and/or marketing other radiopharmaceutical products,
including MDS Nordion Inc., Immunomedics Inc., IBA Molecular, Cytogen
Corporation, International Isotopes Inc. and Molecular Insight Pharmaceuticals, Inc.
FAILURE OF ONE OF
OUR CURRENT OR FUTURE CLINICAL TRIALS COULD HAVE A MATERIALLY NEGATIVE IMPACT
ON OUR FUTURE PROSPECTS.
The development of
new products is subject to a number of significant risks. Potential products that appear to be
promising in various stages of development may not reach the market for a
number of reasons. Such reasons include,
but are not limited to, the possibility that the potential product will be
found ineffective or unduly toxic during preclinical or clinical trials, fails
to receive necessary regulatory approvals, will be difficult to manufacture on
a large scale, will be uneconomical to market or not achieve market acceptance,
will not qualify for third-party reimbursement, or will be precluded from
commercialization by proprietary rights of third parties. Certain products we are attempting to develop
have never been manufactured on a commercial scale, and there can be no
assurance that such products can be manufactured at a cost or in a quantity to
render such products commercially viable.
Production of such products may require the development of new
manufacturing technologies and expertise.
The impact on our business in the event that new manufacturing
technologies and expertise would have to be developed is uncertain. Many of our potential products will require
significant additional research and development efforts and significant
additional preclinical and clinical testing prior to any commercial use. We cannot assure you that we will
successfully meet any of these technological challenges or others that may
arise in the course of product development.
The research and
development process of a new pharmaceutical product can take up to ten years or
longer, from discovery to commercial product launch. New products do not only need to undergo
intensive pre-clinical and clinical testing, but must also pass a highly
complex, lengthy and expensive approval process. During each stage of the process, there is a
substantial risk that we will encounter serious obstacles or will not achieve
our goals and accordingly we may abandon a product in which we have invested substantial
amounts of time and money.
Before obtaining
regulatory approval for the commercial sale of any innovative product under
development, we must demonstrate through preclinical studies and clinical
trials that the product is safe and efficacious. In November 2006, we announced that
DRAXIMAGE had received approval from the FDA to run two clinical trials using
radioactive Iobenguane I-131 Injection (also known as I-131
Metaiodobenzylguanidine or I-131 MIBG) to treat high-risk neuroblastoma, a rare
form of cancer that affects mostly infants and young children, one trial is a
Phase II study and another is a Phase I study.
Both trials are ongoing. The
results of preclinical studies and early-stage clinical trials may not be
totally predictive of results obtained in larger late-stage clinical trials,
and there can be no assurance that our clinical trials will demonstrate safety
and efficacy, achieve regulatory approvals or result in marketable
products. A number of companies in the
biotechnology and pharmaceutical industry have suffered significant setbacks in
advanced clinical trials, even after achieving promising results in earlier
clinical trials.
OUR PROFITABILITY
DEPENDS IN PART ON REIMBURSEMENT POLICIES AND REGULATIONS OF GOVERNMENT
HEALTH ADMINISTRATION AUTHORITIES, PRIVATE
8
HEALTH INSURERS AND OTHER ORGANIZATIONS.
The
business and financial condition of pharmaceutical companies will continue to
be affected by the efforts of governments and third-party payers to contain or
reduce the costs of healthcare through various means. For example, in certain markets, pricing or
profitability of pharmaceutical products, medical devices and diagnostic
products is subject to government control.
In Canada, the Patented Medicine Prices Review Board (PMPRB) monitors
and controls prices of patented drug products marketed in Canada. The PMPRB may assert jurisdiction over our
products under development which may limit the prices that can be charged for
such products in Canada. We may not be
able to obtain prices for our products under development that will make them
commercially viable exclusively in Canada.
In the United States there have been, and we expect that there will
continue to be, a number of federal and state proposals to implement similar
pricing controls by government. In
addition, the emphasis on managed healthcare in the United States has increased
and will continue to increase the pressure on pharmaceutical pricing. While we cannot predict whether such
legislative or regulatory proposals will be adopted or the effects such
proposals or managed healthcare efforts may have on our business, the
announcement of such proposals or efforts could have a material adverse effect
on the market price of our securities and, if adopted, on our business and
financial condition and that of our current and prospective customers. Accordingly, our ability to establish
strategic alliances may be adversely affected.
In addition, in Canada, the United States and elsewhere, sales of
prescription pharmaceutical products and radiopharmaceutical products are
dependent, in part, on the availability of reimbursement to the consumer from
third-party payers, such as government and private insurance plans. Third-party payers are increasingly
challenging the prices charged for medical products and services. To the extent we succeed in bringing new
products to market, we cannot assure you that these products will be considered
cost-effective and that reimbursement to consumers will be available or will be
sufficient to allow the sale of these products on a competitive basis.
Risks Related to our Company
WE ARE EXPOSED TO EXCHANGE RATE
FLUCTUATIONS WHICH COULD NEGATIVELY AFFECT OUR BUSINESS.
A
substantial portion of our consolidated revenues are now, and are expected to
continue to be, realized in U.S. dollars.
Our operating expenses are primarily paid in Canadian dollars. We may be adversely affected by a significant
and rapid strengthening of the Canadian dollar against the U.S. dollar, should
the Canadian dollar rise in value compared to the U.S. dollar by more than 10
cents. We do not currently use
derivative instruments to hedge our foreign exchange risk and currently have no
plans to do so in the near future. For
fiscal year 2007, U.S. dollar revenue accounted for approximately 51% of the
Companys consolidated revenue. During
this same period, the value of the Canadian dollar versus the U.S. dollar
strengthened by 18% from January 1, 2007 to December 31, 2007. As a result, in 2007 we had to charge to
income $1.7 million of foreign exchange loss related to the strengthening of
the Canadian dollar.
OUR
MANUFACTURING FACILITIES ARE CURRENTLY LOCATED IN THE SAME LOCATION AND FACTORS
BEYOND OUR CONTROL COULD CAUSE AN INTERRUPTION IN OUR MANUFACTURING OPERATIONS,
WHICH WOULD ADVERSELY AFFECT OUR REPUTATION IN THE MARKETPLACE AND OUR RESULTS
OF OPERATIONS.
Our manufacturing
facilities are currently located in the same location in Kirkland, Québec. To succeed, we must be able to operate our
manufacturing facilities without significant interruption and deliver
radiopharmaceutical and contract manufacturing products in a timely manner. We
could suffer an interruption in our manufacturing operations caused by damage
from a variety of sources, many of which
9
are not within our control, including fire, flood, earthquake and other
natural disasters; power loss and telecommunication failure; disruption to
transportation systems; major equipment or machinery failure; software and
hardware errors, failures or crashes and similar disruptions; or undue delays
or restrictions with air transport systems and cross-border shipments. Any
significant interruptions in our manufacturing operations or our ability to
receive key raw materials or components or to deliver time-sensitive products
would damage our reputation in the marketplace and have a negative impact on
our results of operations. For example,
our radiopharmaceutical revenues were adversely impacted by lower demand
related to an industry shortage of radioactive medical isotopes in the fourth
quarter of 2007. This was related to an
extended shutdown at one of the largest global suppliers of radioactive
isotopes late in 2007. While the Company
has an alternative approved source of supply for its radioactive isotopes, the
shutdown affects the ability of radiopharmacies to carryout procedures
resulting in lower demand. In addition,
during the third quarter of 2005, DRAXIS Pharma, our contract manufacturing
operating division, extended its regularly scheduled summer shutdown period at
the beginning of the third quarter in the sterile area of our manufacturing
facilities, in order to correct an electrical panel failure and make associated
repairs. The revalidation of the entire
sterile area following these repairs and the related recalibration of
production schedules due to this interruption had material financial
implications which negatively affected third and fourth quarter 2005 results. As a further example, if there were a
cessation of flights leaving Canada for the U.S., then the radiopharmaceutical
products manufactured by DRAXIMAGE, which are delivered in part via airplanes,
could not be delivered to customers on a timely basis and our products would be
harmed due to their short shelf-life.
Also, if there were a prolonged loss of hydroelectric power at our sole
manufacturing facilities, then the manufacturing of our products may be impaired
because we may not have sufficient back-up electrical power from our
independent generators for the duration of the hydroelectric interruption. Although we believe that we carry adequate
property and business interruption insurance, we cannot assure you that we will
be able to maintain such insurance coverage at a reasonable cost or in
sufficient amounts to protect us against all potential eventualities.
In addition,
because our products are intended to promote the health of patients, any supply
disruption could lead to allegations that the public health, or the health of
individuals, has been endangered and could subject us to lawsuits.
IF OUR
COLLABORATIVE AND COMMERCIAL RELATIONSHIPS WITH THIRD PARTIES ON WHOM WE RELY
ARE UNSUCCESSFUL, OUR BUSINESS MAY SUFFER.
To be
successful, we must continually establish and maintain strategic or key
relationships with other companies or organizations in a number of
biotechnology and pharmaceutical industry segments. This is critical to our success because such
relationships enable us to extend the reach of our products and sales in
various jurisdictions, generate additional revenue and develop and deploy new
products in various marketplaces.
Entering into strategic relationships is complicated, as some of our current
and future strategic partners may decide to compete with us in some or all of
the markets in which we operate or refuse to fulfill or honor their contractual
obligations to us. In addition, our
relationships with customers always require us to manufacture products in
accordance with their specifications that are provided to us from time to
time. If we are unable to meet our
customers specifications, our strategic relationships would be harmed.
We
currently have strategic relationships with our four largest customers (i) GlaxoSmithKline
Inc. (GSK) to supply it with established sterile products marketed by GSK in
multiple international markets and a prescription sterile injectable product
for the U.S. market, (ii) Genzyme Corporation (Genzyme) to manufacture
Hectorol® Injection, (iii) Johnson & Johnson Consumer Companies, Inc.
(JJC) to manufacture a broad portfolio of multiple non sterile specialty
semi-solid products currently marketed in the United States, as well as Johnson &
Johnson, Inc. (prior to December 20, 2006, Pfizer Consumer
Healthcare, a division of Pfizer Canada, Inc.), that covers several
non-prescription products for
10
the Canadian market including Polysporin®, Sudafed®
and Actifed®, and (iv) Cardinal Health 414, LLC with respect to our Iodine
I-131 kits, MAA, DTPA and MDP products sold in the U.S.
During
the third quarter of 2007, the Company announced it had expanded its existing
contract manufacturing relationship with JJC and entered into a new definitive
supply agreement to manufacture a broad portfolio of multiple non-sterile
specialty semi-solid products currently marketed in the United States. This new multi-year contract runs to the end
of 2013 and may be extended beyond that date. It includes approximately two
years of manufacturing site transfer and process validation activities followed
by five years of commercial production, that is scheduled to begin in 2009. We
expect commercial production to generate incremental revenues in excess of $120
million over the five year period of 2009 through 2013. The transfer of
equipment and production technologies, currently in progress, is expected to
generate additional cumulative revenues during 2007 and 2008 of approximately
$6 million to $8 million. In 2007,
revenues of $2.6 million were generated from this contract.
On December 20, 2007, DRAXIS announced that
DRAXIMAGE, its radiopharmaceutical division, appointed GE Healthcare, an
industry leader in nuclear medicine, as the exclusive distributor of DRAXIMAGE
®
Sestamibi in the United States. DRAXIMAGE
®
Sestamibi is a generic
kit for the preparation of Technetium (Tc-99m) Sestamibi injection, a
diagnostic cardiac imaging agent used in myocardial perfusion imaging (MPI) to
evaluate blood flow to the heart.
A SIGNIFICANT
PORTION OF OUR BUSINESS IS DEPENDENT ON A SMALL NUMBER OF KEY CUSTOMERS.
For the year ended
December 31, 2007, our four largest customers, GlaxoSmithKline, Genzyme
Corporation, Johnson & Johnson Inc. (which includes JJC) and Cardinal
Health 414, LLC, represented 55% of our consolidated revenues (19%, 15%, 11%
and 10% respectively). The termination by any of these customers of its
relationship with us would have a material adverse effect on our business,
financial condition and results of operations unless we could replace these
customers in a timely fashion. Moreover,
we are exposed to a concentration of credit risk as a result of this
concentration among our customers. Should
one or more of our key customers experience financial difficulties, the effect
would be substantially greater than it would have been the case in the
past. Each of these factors could have a
material negative impact on our results of operations.
IF OUR
COLLABORATORS, EMPLOYEES, OR CONSULTANTS DISCLOSE OUR CONFIDENTIAL INFORMATION
TO OTHERS DESPITE CONFIDENTIALITY AGREEMENTS IN PLACE, OUR BUSINESS MAY SUFFER.
Our
practice is to require our key employees, collaborators, consultants and
outside scientific advisors to execute confidentiality agreements upon the
commencement of employment or consulting relationships. These agreements provide that all
confidential information developed or made known to the individual during the
course of the individuals relationship with us is to be kept confidential and
not disclosed to third parties, subject to certain specific limited
exceptions. In the case of employees,
the agreements provide that all inventions conceived by the individual shall be
our exclusive property. These
agreements, however, may not provide meaningful protection for our trade
secrets or adequate remedies in the event of unauthorized use or disclosure of
such information. For example, trade
secrets regarding the recipe to manufacture our radiopharmaceutical kits or
capsule products could be disclosed, allowing our competitors to copy the
recipe and manufacture a competing product.
WE ARE SUBJECT TO
REGULATION BY GOVERNMENTS IN MANY JURISDICTIONS AND, IF WE DO NOT COMPLY WITH
MANUFACTURING, NUCLEAR SAFETY AND ENVIRONMENTAL REGULATIONS, OUR EXISTING AND
FUTURE OPERATIONS MAY BE CURTAILED, AND WE COULD BE SUBJECT TO LIABILITY.
11
Pharmaceutical drug manufacturing is a highly regulated industry,
requiring significant documentation and validation of manufacturing processes
and quality control assurance prior to approval of the facility to manufacture
a specific drug. There can be
considerable transition time between the initiation of a contract to
manufacture a product and the actual initiation of the manufacturing of that
product. Any lag time in the initiation
of a contract to manufacture a product and the actual initiation of the
manufacturing at our facilities could cause us to lose profits.
We have in place facilities and procedures designed to reduce and, to
the extent possible, eliminate the risk of environmental contamination
resulting from the processing of raw materials and, more specifically, from the
radiopharmaceutical business of DRAXIMAGE and the contract manufacturing
business of DRAXIS Pharma. We also have
in place regular maintenance programs to ensure continued compliance with all
applicable health and safety, environmental and nuclear safety
regulations. We believe that the
operations at our manufacturing facilities comply in all material respects with
applicable health and safety, environmental and nuclear safety laws.
Canadian and U.S. federal, state, local and provincial regulations
govern extensively the use, manufacture, storage, handling, transport and
disposal of hazardous material and associated waste products. Although we believe that the operations at
our facilities comply in all material respects with applicable laws and
regulations, we cannot completely eliminate the risk of substantial
environmental liabilities especially in respect of environmental contamination
resulting from the processing of raw materials from the radiopharmaceutical
business of DRAXIMAGE and the manufacturing business of DRAXIS Pharma. Any failure by us or any of our subsidiaries
to comply with such present or future laws and regulations could result in any
of the following: (i) cessation of portions or all of our or our
subsidiaries operations; (ii) imposition of fines; (iii) restrictions
on our or our subsidiaries ability to carry on or expand our operations; (iv) significant
expenditures by us in order to comply with laws and regulations; or (v) liabilities
in excess of our resources. As of December 31,
2007, we have not received any notice stating that we are not in compliance
with any such legislation applicable to us.
OUR BUSINESS COULD
BE HARMED IF THERE WERE A DISPUTE OR DISRUPTION WITH OUR UNIONIZED EMPLOYEES.
The
products manufactured by DRAXIS Pharma represent a significant amount of our
consolidated revenues. For the year
ended December 31, 2007,
69.7
% of our consolidated revenues were derived from DRAXIS Pharma. Although a collective agreement with a
five-year term to April 30, 2008 between DRAXIS Pharma and the United Food &
Commercial Workers International Union, Local 291 (AFL-CIO) was ratified in February 2004,
we cannot assure you that labour difficulties will not arise, and if they did
arise then the production and delivery of those products manufactured by DRAXIS
Pharma would be impaired for the duration of those labor difficulties. Those products manufactured by DRAXIMAGE may
also be impaired if access to our sole manufacturing facilities is hindered by
these labor difficulties. The present collective agreement terminates on April 30,
2008. We are presently preparing to
negotiate a new collective agreement with the union and cannot assure you that
we will negotiate the same terms as the existing agreement.
OUR FUTURE SUCCESS
DEPENDS ON OUR ABILITY TO GROW, AND IF WE ARE UNABLE TO MANAGE OUR GROWTH
EFFECTIVELY, WE MAY INCUR UNEXPECTED EXPENSES AND BE UNABLE TO MEET OUR
CUSTOMERS REQUIREMENTS.
We will
need to maintain, expand and upgrade our manufacturing facilities and
operations to execute current commercial obligations to customers, widen our
customer base and increase manufacturing efficiencies over the next few
years. We cannot be certain that DRAXIS
Pharma will be able to enter into enough lucrative third-party manufacturing
contracts to increase its profitability.
If we
12
do secure advantageous agreements, we cannot be
certain that our employees, systems, procedures, controls, productive capacity
and existing space will be adequate to support expansion of the
operations. Our future operating results
will depend on the ability of our officers and key employees to manage changing
business conditions and to implement and improve our technical, administrative,
financial control and reporting systems and operational excellence in order to
achieve established business objectives.
An unexpectedly large increase in the volume of manufacturing business
or the number of orders placed by customers may require us to expand capacity
and further upgrade our manufacturing facilities and the technology related to
our manufacturing. We may not be able to
project the rate of timing of such increases or customer demands accurately or
to expand and upgrade our manufacturing facilities and supporting systems and
infrastructure to accommodate such increases.
Difficulties in managing future growth and meeting customers expanded
requirements could have a significant negative impact on our business and its
profitability.
IF OUR
INTERNAL CONTROLS OVER FINANCIAL REPORTING ARE FOUND NOT TO BE EFFECTIVE OR IF
WE MAKE DISCLOSURE OF EXISTING OR POTENTIAL SIGNIFICANT DEFICIENCIES OR
MATERIAL WEAKNESSES IN THOSE CONTROLS, INVESTORS COULD LOSE CONFIDENCE IN OUR
FINANCIAL REPORTS, AND OUR STOCK PRICE MAY BE ADVERSELY AFFECTED.
Beginning
with this Annual Report (Form 20-F) for the year ending December 31,
2007, Section 404 of the Sarbanes-Oxley Act of 2002 requires us to include
a report of management on the Companys internal control over financial
reporting with our Annual Report (Form 20-F). That report must include managements
assessment of the effectiveness of our internal control over financial
reporting as of the end of the fiscal year.
Additionally, beginning with our Annual Report for the year ending December 31,
2007, our independent registered public accounting firm is required to issue a
report on the effectiveness of our internal controls over financial
reporting. This Annual Report (Form 20-F)
includes a report on the effectiveness of our internal controls over financial
reporting from our independent registered public accountants as of December 31,
2007.
We continue
to evaluate our existing internal controls over financial reporting according
to the standards adopted by the Public Company Accounting Oversight Board
(PCAOB). During the course of our
ongoing evaluation of the internal controls, we may identify areas requiring
improvement, and may have to design enhanced processes and controls to address
issues identified through this review.
Despite the existence of material weaknesses or significant deficiencies
in our internal controls over financial reporting, we may fail to identify
them. Remedying any deficiencies,
significant deficiencies or material weaknesses that we and/or our independent
registered public accounting firm are able to identify, may require us to incur
significant costs and expend significant time and management resources. Further, any of the measures we implement to
remedy any such deficiencies may not effectively mitigate or remedy such
deficiencies.
Any
failure to remedy the deficiencies identified by management, any failure to implement
required new or improved controls and the discovery of unidentified
deficiencies could harm our operating results, cause us to fail to meet our
reporting obligations, subject us to increased risk of errors and fraud related
to our financial statements or result in material misstatements in, and
untimely filing of, our financial statements.
The existence of a material weakness could also cause a restatement of
future presented financial statements.
Investors could lose confidence in our financial reports, and our stock
price may be adversely affected, if our internal controls over financial
reporting are found not to be effective by management or by an independent
registered public accounting firm, or if we make disclosure of existing or
potential significant deficiencies or material weaknesses in those controls.
OUR FINANCIAL
RESULTS MAY FLUCTUATE, AND OUR FUTURE REVENUE AND
13
PROFITABILITY ARE UNCERTAIN.
Our
ability to achieve and maintain profitability in the foreseeable future depends
on the commercial success of our products and services. Because we have recently launched new
products in new markets such as our SMART-FILL
Ô
Capsule Filler which was launched in the U.S. in August 2007,
revenues are difficult to predict and may fluctuate substantially from period
to period. In addition, product
development programs will require substantial additional investment, including
the cost of clinical trials for innovative products (such as the costs of our
clinical trials for DRAXIMAGE
Ò
I-131 MIBG) and obtaining regulatory approvals for the sale of our
products such as DRAXIMAGE
Ò
Sestamibi for which we filed an ANDA with the FDA in February 2007,
a submission to European authorities in July 2007 and an A/NDS in Canada
in August 2007. Our sole
manufacturing facilities will continue to require capital investment in order
to maintain, upgrade and expand their operations. The success of DRAXIMAGE and DRAXIS Pharma
will rely significantly on the ability of both divisions to maintain and to
substantially increase their manufacturing capabilities to satisfy customer
demand. There can be no assurance that,
or when, we will successfully develop, receive regulatory approvals for, or
manufacture or market any new products for our own marketing purposes or for
third parties. DRAXIS Pharma may fail to
renew its existing manufacturing contracts or may fail to secure sufficiently
lucrative new third-party manufacturing contracts to increase its
profitability. For example, revenues for
DRAXIMAGE were impacted in the fourth quarter of 2007 by lower demand related
to an industry shortage of radioactive medical isotopes. This was related to an extended shutdown at
one of the largest global suppliers of radioactive isotopes late in 2007. While DRAXIMAGE has an alternative FDA
approved source of supply of its radioactive isotopes, the shutdown affected
the ability of radiopharmacies to carryout procedures resulting in lower
demand. In addition, DRAXIS Pharma may
lose anticipated volumes of products if the customers for whom it manufactures
said products do not receive required approvals for the commercial sale of
same. DRAXIS Pharma may also lose
anticipated volumes of existing products if its customers lose market share for
products due to decreased demand for said products. DRAXIMAGE may fail to increase its market
penetration of its radioactive products, particularly in the U.S. DRAXIMAGE may also fail to increase its
international sales of its key Tc-99m kits and Iodine I-131 products,
particularly in Europe, if it does not receive approvals to market said
products or if it is not able to capture a significant market share for those
products once they are approved.
DRAXIMAGE may not receive timely regulatory approval of its DRAXIMAGE
Ò
Sestamibi product. The research,
development, production and marketing of new products like MOLY-FILL
Ô
(our Technetium Tc-99m Generator) or DRAXIMAGE
Ò
I-131 MIBG will require the application of considerable technical and
financial resources by us and our customers, while revenues that are generated
by such products, if approved and successfully developed and marketed, may not
be realized for several years. We may
not be able to sustain current and planned levels of profitability. We may require external financing to complete
certain aspects of our three-year strategic plan, and external sources of
capital may not be available to us at an acceptable cost, if at all.
IF WE CANNOT ADAPT
TO CHANGING TECHNOLOGIES, OUR PRODUCTS AND SERVICES MAY BECOME OBSOLETE
AND OUR BUSINESS COULD SUFFER.
Because the
biotechnology, pharmaceutical and radiopharmaceutical industry is characterized
by technology change and obsolescence, we may be unable to anticipate changes
in our current and potential customer requirements that could make our existing
technology obsolete. Our success will
depend, in part, on our ability to continue to enhance our existing products
and services, develop new technology that addresses the increasing
sophistication and varied needs of our respective customers, license leading
technologies and respond to technological advances and emerging industry
standards and practices on a timely and cost-effective basis. The development of our proprietary technology
and investing in certain niche markets entails significant technical, financial
and business risks. We may not be
successful in
14
using our new technologies or exploiting our niche markets effectively
or adapting our businesses to evolving customer requirements or emerging
industry standards.
DRAXIMAGE has also
identified additional new product opportunities in the area of non-radioactive
contrast media that are used in the medical imaging field and is pursuing
potential product development strategies to leverage both its position in the
marketplace and its preferred access to appropriate production
process expertise. Contrast media
products are injectable liquids produced in highly-specialized cGMP sterile
production facilities, such as those in place at DRAXIS facilities which are
currently used to produce certain diagnostic imaging products marketed by
DRAXIMAGE. The North American market for contrast media has been estimated to
be valued at approximately $1.6 billion and we believe that is growing driven
largely by the continued growth of computer tomography (CT) and enhanced
magnetic resonance imaging (MRI) procedures.
AN INABILITY TO
ATTRACT AND RETAIN QUALIFIED PERSONNEL COULD ADVERSELY AFFECT OUR BUSINESS
Our success
depends upon skilled personnel in key parts of the Company. The loss of the service of key members of the
Company, particularly principal members of our management team, may delay or
prevent achievement of major business objectives. We have employment agreements with all
principal members of our management team with no fixed duration. We face intense competition for qualified
individuals from numerous pharmaceutical companies, universities, governmental
entities and other research institutions.
As a result, we may be unable to attract and retain qualified
individuals in sufficient numbers, which would have a material negative impact
on our results of operations.
ALTHOUGH
WE CONSIDER THE COMPANY TO HAVE GOOD DEFENSES TO SUCH ACTIONS, SHOULD THE
CURRENT LAWSUITS AGAINST US SUCCEED, WE COULD INCUR A SUBSTANTIAL LOSS.
In 1998, a
Canadian legal proceeding was launched against us and our subsidiary DAHI by a
former consultant, Jozsef Knoll, claiming royalty entitlements based on the net
profit from sales of
ANIPRYL
®
(the Knoll proceeding). Total damages
claimed are $100 million, including a claim to certain shares of DAHI. However,
the plaintiff has taken no steps in the last eight years to move the claim
forward. While we believe that we have
good defenses to the Knoll proceeding, this dispute may not be resolved in our
favor, if it is pursued. It is possible
that a court or arbitration tribunal may find us to be in breach of certain
agreements, or infringing validly issued patents of third parties or practicing
the intellectual property of others. In
that event, in addition to the cost of defending the underlying proceeding, we
may have to pay license fees, additional royalties and/or damages and may be
ordered to assign certain
ANIPRYL®-
related
patents and be prohibited from conducting certain activities. Under such circumstances, we could incur
substantial loss and our business could be negatively affected.
On July 22,
2005, we announced that, together with other defendants, we had received a
Statement of Claim filed before the Superior Court of Justice of Ontario
alleging that Permax
Ò
, a drug that we distributed in Canada
for a third party manufacturer prior to July 2003, causes
compulsive/obsessive behaviour, including pathological gambling. The plaintiff is seeking to have this action
certified as a class action. We believe
this claim against us is without merit and we intend to vigorously defend this
proceeding and any motion for certification.
Prior to July 2003, Permax
Ò
was distributed in Canada by DRAXIS
Pharmaceutica, our Canadian pharmaceutical sales and marketing division. In July 2003, we sold the DRAXIS
Pharmaceutica division to Shire. On February 29, 2008, the plaintiff
served an Amended Statement of Claim and a Motion Record in support of the
plaintiffs motion for certification of this action as a class proceeding. The defendants must file a response to
plaintiffs motion for certification by July 31, 2008.
15
Risks Related to our Common Shares
OUR
COMMON SHARE PRICE HAS BEEN, AND IS LIKELY TO CONTINUE TO BE, VOLATILE.
The market prices for the securities of smaller
pharmaceutical and biotechnology companies, including ours, have historically
been volatile, and the market has, from time to time, experienced significant
price and volume fluctuations that are unrelated to the operating performance
of particular companies. For the last
two fiscal years, the price of our stock has ranged from a low of $3.27, to a
high of $6.64 on NASDAQ (CDN$3.29 to CDN$7.59 on the Toronto Stock
Exchange). We believe that in the first
half of 2007 the increase in the share price and volumes of shares traded was
impacted by positive financial results that differed from market expectations
as well as an increased recognition of the potential future value of the
products in our R&D pipeline, particularly products under development at
DRAXIMAGE. We believe that the reduction
of the share price and volumes of shares trading in the second half of 2007
occurred as a result of significant declines in financial performance that were
well below market expectations and that caused the Company to twice reduce its
earnings guidance during this period.
We believe that in
the first half of 2006 the volatility in the share price and volumes of shares
traded was impacted by financial results that differed from market expectations
as a continuing result of the extended shutdown in 2005 of production of
sterile products at DRAXIS Pharma. We believe that the appreciation of the
share price and volumes of shares trading in the second half of 2006 occurred
as a result of improved financial results that came closer to market
expectations and a growing recognition of the potential value of new products in
development.
Factors such as
fluctuations in our operating results, announcements of competing technological
innovations or new products by our competitors, clinical trial results,
governmental regulation and enforcement actions, developments in patent or
other proprietary rights, public concern as to the safety of drugs developed by
us or others and general market conditions can have an adverse effect on the
market price of our shares. In
particular, the realization of any of the risks described herein could have a
material adverse impact on such market price.
Unusual sales of substantial amounts of our shares in the public market
over a relatively short time period, or the perception that such sales will
occur, could also adversely affect the market price of our shares and make it
more difficult in the future for us to raise funds through equity offerings.
Item 4. Information
on the Company
DRAXIS is a specialty pharmaceutical company providing products in three
categories: sterile products, non-sterile products and
radiopharmaceuticals. Sterile products
include liquid and freeze-dried (lyophilized) injectables and sterile
ointments. Non-sterile products are
produced as solid oral, liquid and semi-solid dosage forms. Radiopharmaceuticals are used for both
therapeutic and diagnostic molecular imaging applications. In the radiopharmaceutical category, DRAXIS
has its own products and a targeted research and development program for new
products. As of January 1, 2005,
all of the operations of the Company are carried out through our wholly owned
subsidiary DRAXIS Specialty Pharmaceuticals Inc., which operates two major
divisions, DRAXIS Pharma (contract manufacturing) and DRAXIMAGE
(radiopharmaceuticals). For the year
ended December 31, 2007, 69.7% of our consolidated revenues were derived
from DRAXIS Pharma (contract manufacturing) and 29.4% of our consolidated
revenues were derived from DRAXIMAGE (radiopharmaceuticals).
In addition, DRAXIS has continuing financial interests associated with
its collaboration agreements with Pfizer Inc. with respect to
ANIPRYL
®
.
16
Our consolidated operations are integrated across research, product
development, manufacturing, sales and marketing, as well as the in-licensing
and commercial development of radiopharmaceutical products and technologies.
DRAXIS has emerged from a transitional phase of its development. In past years, we were reliant on income
earned from
ANIPRYL
®
. For the year ended December 31, 2007, our
collaboration agreement with Pfizer Inc. with respect to
ANIPRYL
®
represented 2.2%
of our consolidated revenues which represented the majority of our income from
royalties and licensing.
The common shares of DRAXIS are listed on the Toronto Stock Exchange
(ticker symbol DAX) and on NASDAQ (ticker symbol DRAX). The shares of DRAXIS have been included in
the NASDAQ Healthcare Index
Ò
(symbol: IXHC) since July 27,
2005 and the NASDAQ Global Select Market
SM
since July 3, 2006.
Our registered office is located at Suite 4700, TD Bank Tower,
Toronto Dominion Centre, Toronto, Ontario, M5K 1E6, Canada. Our telephone
number at this location is 416- 601-7525.
The Companys only manufacturing, research and development facilities
are located at 16751 Trans-Canada Road, Kirkland, Québec, Canada, H9H 4J4. Our telephone number at this location is
514-694-8220.
The Companys website is:
www.draxis.com.
History and Development of the Company
DRAXIS Health Inc. (DRAXIS) was incorporated under the name Deprenyl
Research Limited on October 13, 1987 under the
CBCA
. The Company was
founded principally to engage in the marketing in Canada of prescription
pharmaceuticals discovered, developed or acquired by Chinoin Pharmaceutical and
Chemical Works Co. Ltd., the first of which was
ELDEPRYL
®
(selegiline;
1-deprenyl), for the treatment of Parkinsons disease. We changed our name to DRAXIS Health Inc. in May 1994.
We completed an initial public offering of our common shares in February 1988
on the Toronto Stock Exchange. Our
common shares were listed on NASDAQ in August 1989.
Beginning in 1990, we expanded our scientific knowledge of selegiline
through contract research arrangements, to use with companion animals. This ultimately resulted in the formation of
our subsidiary DAHI, through which we developed and commercialized a companion
animal health product,
ANIPRYL
®
.
In 1991, we began to invest in the applications of aminolevulinic acid
photodynamic therapy, which resulted in the formation of a subsidiary, DUSA
Pharmaceuticals, Inc. (DUSA).
Through a series of transactions from 1991 to 1996, we divested all of
our interest in DUSA.
By late 1992, we faced considerable uncertainty due to the impending
threat of generic competition for
ELDEPRYL
®
,
which, at that
time, still accounted for almost 100% of our consolidated revenues. Faced with this as well as other business
challenges, in 1992 we began the process of recruiting new senior management to
develop and implement a new strategic business plan for the Company to (i) address
the generic threat to our lead drug by expanding and diversifying our
established Canadian pharmaceuticals franchise; (ii) strengthen our
financial position; and (iii) diversify from our historical Canadian base
through the acquisition of niche pharmaceutical products and/or
manufacturing-oriented businesses with international growth potential.
17
In 1993, the leadership of the Company changed with the appointment of Dr. Martin
Barkin as President and Chief Executive Officer. Several measures were taken to strengthen our
financial position and to address the threat of generic competition for
Eldepryl
Ò
, including (i) expanding
and diversifying our established Canadian pharmaceutical business, and (ii) diversifying
our product mix through the acquisition of niche pharmaceutical products which
the Company believed had the potential for global growth.
In April 1996, a public offering of 3,000,000 common shares
generated net proceeds of $8.5 million.
In November 1996, we acquired the shares of DAHI that we did not
previously own through a mandatory share exchange transaction valued at $17.4
million.
In July 1997, we acquired from Merck Frosst Canada Inc. its
radiopharmaceutical business, which became DRAXIMAGE Inc. (since January 1,
2005, known as DRAXIMAGE, a division of DRAXIS Specialty Pharmaceuticals Inc.).
In December 1997, we licenced the worldwide marketing rights for
Anipryl
Ò
to Pfizer but
retained manufacturing rights for the product.
Cumulatively to December 31, 2007 $46.4 million has been received
in upfront and milestone payments, royalties and royalty-related payments from
Pfizer.
In May 1998, we acquired our current manufacturing facilities in
Kirkland, Québec for $11.1 million.
During the period of 1998 to 2000, we undertook a capital expansion
plan, adding our lyophilization and our radiopharmaceutical operations. Our
operations subsequently expanded over the following two years to support our
new contract manufacturing and radiopharmaceutical business, respectively. In 2000, we sold a 34.1% equity interest in
DRAXIS Pharma Inc. (since January 1, 2005 known as DRAXIS Pharma, a
division of DRAXIS Specialty Pharmaceuticals Inc.) to SGF Santé Inc. (SGF)
and DRAXIS Pharma senior management to help finance the lyophilization
expansion at our facilities.
In 2000, we also divested our dermatology product lines to Block Drug
Company (Canada) Limited (now part of GlaxoSmithKline Consumer Healthcare).
In 2001, we began producing DRAXIMAGE products in our facilities.
In 2001, DRAXIS Pharma signed a long term supply agreement to
manufacture several GSK products for multiple international markets.
In 2003, we launched a new radiotherapeutic Iodine I-131 kit in the U.S.
for the treatment of thyroid cancer and hyper-thyroidism and received $6.5
million from affiliates of Elan Corporation, plc (Elan) for the return of
Canadian rights for several neurology products.
In July 2003, we also sold DRAXIS Pharmaceutica, our Canadian sales
and marketing division, to Shire BioChem Inc. for $9.6 million in cash plus up
to $2-9 million in market driven contingent milestones.
On April 22, 2004, we issued 3,053,436 units of the Company at a
purchase price of $4.82 (CDN$6.55) per unit, for aggregate proceeds net of
related expenses of $13.4 million (CDN$18.2 million). Each unit consisted of one common share of
DRAXIS and one-half of one share purchase warrant. Each whole warrant entitled the holder to
acquire one common share of DRAXIS at a price of
18
CDN$8.50 at any time prior to April 24,
2006.
The warrants were transferable. Holders of warrants
did not, as such, have any voting rights or other right attaching to the common
shares until the warrants were properly exercised and common shares issuable
upon the exercise of the warrants were issued.
All warrants expired unexercised on April 24, 2006.
On April 22,
2004, DRAXIS acquired SGFs 32.7% interest in DRAXIS Pharma for a cash
consideration of $9.6 million (CDN$13 million).
DRAXIS used part of the proceeds from the offering completed in April 2004
to pay for the acquisition and to repay $3.1 million (CDN$4.2 million) in debt
owed by DRAXIS Pharma to SGF and $1.7 million (CDN$2.3 million) in debt owed by
DRAXIS Pharma to Investissement Québec.
The DRAXIS Pharma senior management interest was also bought so that the
Company became the sole shareholder of DRAXIS Pharma.
In June 2004, we
negotiated new credit facilities with our bankers, the National Bank of Canada,
providing an operating facility of CDN$15 million (or U.S. equivalent), payable
within 364 days of drawing upon the facility and a term facility of CDN$10
million (or U.S. equivalent), repayable in full in three years.
The Company chose not to renew its credit facilities
upon their scheduled expiration date in June 2007. The Company plans to
explore new credit facility arrangements in conjunction with new business
opportunities. The Company believes that its current cash position and cash
flows are sufficient to achieve the Companys current business plans.
In November 2004, we
received FDA approval for a DRAXIMAGE
Ò
brand of Iodine-131
therapeutic capsules.
In
December 2004, we repaid all of our third-party debt.
As of January 1, 2005, we
amalgamated our two wholly-owned subsidiaries, DRAXIS Pharma Inc. and DRAXIMAGE
Inc., to achieve certain business and tax efficiencies. The amalgamated subsidiary, called DRAXIS
Specialty Pharmaceuticals Inc., continues to conduct business as two divisions,
DRAXIS Pharma (contract manufacturing) and DRAXIMAGE (radiopharmaceuticals),
and serves as our operating arm.
In February 2005,
we announced that DRAXIMAGE had received approval from the Dutch regulatory
authority for its kit for the preparation of Technetium Tc-99m Albumin
Aggregated Injection (MAA Kit). This
approval allowed DRAXIMAGE to initiate the Mutual Recognition Procedure (MRP)
in pursuit of further regulatory approvals for the diagnostic imaging product
in additional European Union countries.
In April 2005,
we announced the appointment of Mr. Jean-Pierre Robert as the new
President of the DRAXIMAGE division effective as of May 9, 2005.
In October 2005,
we announced the appointment of Mr. Dan Brazier to the newly created
position of Chief Operating Officer.
In November 2005,
DRAXIMAGE announced that it would discontinue the manufacture and sale of
implantable brachytherapy seeds as of December 15, 2005.
In January 2006,
we announced we had received approval from the FDA for our supplemental drug
application for Sodium Iodide I-131 Capsules USP, Diagnostic-Oral. We began selling these capsules in the U.S.
in May 2006.
In March 2006,
we announced that although our product
FIBRIMAGE
Ò
had
met primary end
19
points in its Phase III clinical trial in Canada, further market
analysis had shown that new technologies have successfully captured the current
deep venous thrombosis indications and that there was no longer an economically
interesting market opportunity at the time in either the at-risk asymptomatic
patient, or those with symptoms. We
further indicated that we had decided that no significant further work would be
conducted in the development of this product for its current indications but
other potential opportunities for this product would be explored. In 2006 and 2007, no other potential
opportunities were uncovered.
In November 2006,
DRAXIMAGE was approved by the FDA to run two clinical trials using radioactive
Iobenguane I-131 Injection (also known as I-131 Metaiodobenzylguanidine or
I-131 MIBG) to treat high risk neuroblastoma, a rare form of cancer that
affects mostly infants and young children.
These trials are ongoing.
In February 2007,
DRAXIMAGE announced it had submitted an ANDA to the FDA for its generic kit for
the preparation of Tc-99m Sestamibi for injection (DRAXIMAGE
Ò
Sestamibi), a nuclear medicine imaging agent used in MPI to evaluate blood flow
to the heart in patients undergoing cardiac tests. On July 7, 2007, the Company was
informed by the FDA that its ANDA submission was accepted for filing. On July 25, 2007, DRAXIMAGE announced it
had filed DRAXIMAGE
Ò
Sestamibi with European regulatory
authorities. The Company also filed an
A/NDS for DRAXIMAGE
Ò
Sestamibi on August 17, 2007 with
Health Canada. On October 11, 2007,
the Company was informed by Health Canada that this submission had been
screened and found acceptable for review.
We cannot predict if or when we will receive regulatory approvals to
market this product.
In September 2007,
the Company announced it had expanded its existing contract manufacturing
relationship
with
JJC and entered into a new definitive supply
agreement to provide commercial manufacturing services for a broad portfolio of
multiple non-sterile specialty semi-solid products currently marketed in the
United States.
In connection with
the supply agreement with JJC, DRAXIS Pharma also signed a credit agreement
with Johnson & Johnson Finance Corporation (JJFC) as of September 4,
2007 which provides that JJFC shall provide credit facilities of up to $12.2
million. The credit facilities will be
used by DRAXIS Pharma solely to finance the acquisition and installation of
equipment and to finance the cost of transfer of the technology required for
the pre-validation work in support of the manufacture by DRAXIS Pharma of the
products under the supply agreement.
On October 31,
2007, the Company announced that Dr. Martin Barkin informed the Board of
Directors that he would retire as President and Chief Executive Officer of the
Company effective December 31, 2007.
For the period of January 1, 2008 to January 9, 2009, he will
act as a Special Advisor to the Board of the Company.
On November 1,
2007, DRAXIS announced that the Company was ceasing all further activities
related to its product
INFECTON
Ò
and redeploying its development teams to other
projects following the results of additional formulations for the product which
indicated that sufficient specificity and sensitivity could not be achieved in
a cost effective manner which would be commercially important.
On December 20,
2007, DRAXIS announced that DRAXIMAGE, its radiopharmaceutical division, has
appointed GE Healthcare, an industry leader in nuclear medicine, as the
exclusive distributor of DRAXIMAGE
®
Sestamibi in the United States.
DRAXIMAGE
®
Sestamibi is a generic kit for the preparation of
Technetium (Tc-99m) Sestamibi injection, a diagnostic cardiac imaging agent
used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart. GE Healthcare will be able to sell DRAXIMAGE
®
Sestamibi once the primary innovator patent expires and marketing
authorizations
20
are received from the FDA.
Recent Developments
In response to a
request by securities regulators with respect to increased trading in its
common stock, DRAXIS announced on March 17, 2008 that it is currently in
exclusive discussions regarding a potential transaction that could lead to a
sale of the Company. There can be no
certainty at this stage that these discussions will continue or result in any
agreement or transaction or result in pricing that will be acceptable either to
the Board of Directors of the Company or to its shareholders.
The Board of
Directors of DRAXIS appointed Mr. Dan Brazier, the Companys Chief
Operating Officer since October 2005, as the new President and Chief
Executive Officer effective January 1, 2008 and Mr. Jean-Pierre
Robert as Chief Operating Officer of DRAXIS. Mr. Robert is also President
of DSPI.
For information concerning the
Companys capital expenditures and methods of financing, please see Item 5:
Operating and Financial Review and Prospects.
Business Strategy
We believe that both DRAXIMAGE and DRAXIS Pharma have
significant long-term growth potential and have invested considerable financial
and management resources in developing these businesses.
Our general business
strategy is to:
·
Focus on specialty pharmaceutical markets in which we
can develop and sustain a competitive advantage.
·
DRAXIS has focused its operations on two core
businesses: radiopharmaceuticals and
specialty pharmaceutical contract manufacturing. Both businesses target highly differentiated,
specialized markets which feature significant regulatory requirements and
specialized manufacturing requirements and standards.
·
Develop new pharmaceutical products and services
consistent with our strengths and capabilities.
·
DRAXIS has established a growing franchise in the
highly differentiated radiopharmaceutical segment with a portfolio of 22
currently marketed products plus innovative proprietary products in various
stages of development, including DRAXIMAGE
Ò
Sestamibi for which DRAXIMAGE filed an ANDA with the FDA in February 2007,
a submission to European authorities in July 2007 and an A/NDS in Canada
in August 2007 and MOLY-FILL
Ô
, a next-generation version of a
Technetium Tc-99m Generator. In addition to our radiopharmaceutical platform,
our expanding lyophilization capability positions us to offer new services to
customers and to take advantage of growth opportunities in contract
manufacturing.
·
Pursue growth opportunities with international market
potential.
·
We are leveraging our capabilities, experience and
regulatory compliance in radiopharmaceuticals and manufacturing to expand our
product and service offerings in the United States, Europe and other
international markets.
21
·
Leverage alliances with customers.
·
We are pursuing multiple opportunities with new and
existing customers. Meeting the strict
quality and service standards of such customers positions us to expand on these
relationships in both our radiopharmaceuticals and pharmaceutical contract
manufacturing businesses.
Our
primary operational focus for 2008 continues to be: (i) improving
near-term financial and operational performance of our radiopharmaceutical and
manufacturing businesses through increasing sales of existing products and
services, improving manufacturing efficiency and effectiveness, and obtaining
additional regulatory approvals; and (ii) securing and advancing our base
for long-term growth through the development of our existing product pipeline
as well as identifying new business opportunities that are consistent with our
capabilities and that contribute to the long-term value of the Company.
The following is a description of the principal
markets in which we operate and a breakdown of total revenues by segment and
geographic market for the three most recent financial years(1):
Geographic Segmentation
|
|
2007
|
|
2006
|
|
2005
|
|
REVENUES(2)
|
|
|
|
|
|
|
|
Canada
|
|
$
|
36,061
|
|
$
|
39,891
|
|
$
|
39,026
|
|
United States
|
|
40,336
|
|
47,900
|
|
39,612
|
|
Other
|
|
2,463
|
|
1,176
|
|
795
|
|
|
|
$
|
78,860
|
|
$
|
88,967
|
|
$
|
79,433
|
|
(1) See
Note 19 in our 2007 Consolidated Financial Statements and Notes beginning on page F-1
(2) Revenues
are attributable to countries based upon the location of the customer.
Product Sales Revenues
By Major Product Groups
|
|
2007
|
|
2006
|
|
2005
|
|
Radiopharmaceuticals
|
|
$
|
23,216
|
|
$
|
21,508
|
|
$
|
19,290
|
|
Manufacturing -
Sterile
|
|
38,620
|
|
51,529
|
|
41,488
|
|
Manufacturing -
Non-Sterile
|
|
16,306
|
|
13,202
|
|
13,255
|
|
Corporate and
Other
|
|
686
|
|
295
|
|
499
|
|
Inter-segment
eliminations
|
|
(2,756
|
)
|
(2,989
|
)
|
(1,543
|
)
|
|
|
$
|
76,072
|
|
$
|
83,545
|
|
$
|
72,989
|
|
Our two main operating businesses, radiopharmaceuticals and contract
manufacturing (sterile and non-sterile products), are not characterized by
significant seasonality. However, plant
activities at DRAXIS Pharma (contract manufacturing) are generally reduced or
shut down once a year, usually during our third quarter, for approximately two
to four weeks in order to conduct regular required maintenance.
DRAXIMAGEs principal raw materials are radioactive isotopes,
particularly radioactive iodine isotopes, that are used to label other
compounds that act as carriers or molecular targeting agents. The isotopes are obtained from companies and
agencies that are licensed by governmental regulators to produce purified
radioactive chemicals. Radioactive
materials, by their nature, decay over time some rapidly and some more
slowly, depending on specific isotopes.
Therefore, DRAXIMAGE receives shipments of chemical-grade radioisotopes
several times each week and converts these to finished pharmaceutical-grade
products within days or weeks. While
prices of selected isotopes can be somewhat volatile over the medium term,
DRAXIMAGE endeavors to negotiate long-term supply arrangements with appropriate
suppliers, especially for the more important isotopes such as radioactive
Iodine.
22
DRAXIS Pharma, as a contract manufacturer of pharmaceutical products,
obtains its chemical raw materials from approved chemical suppliers of both
active pharmaceutical ingredients (API) and inactive or excipient ingredients
such as fillers, stabilizers, preservative agents and coloring agents. In many instances the API is supplied by the
customer. DRAXIS Pharma conducts full
quality control testing of all ingredients and packaging materials before they
are incorporated into the finished product.
Prices of principal API are not generally volatile, although prices can
vary between alternative suppliers.
Contract Manufacturing (DRAXIS Pharma)
Contract manufacturing accounted for 69.7% of our consolidated revenues
for the year ended December 31, 2007.
Our DRAXIS Pharma division is responsible for our contract
pharmaceutical manufacturing and has capabilities in a broad range of dosage
forms, specializing in liquid and lyophilized (freeze-dried) injectables and
other sterile products. Operating out of
a cGMP-compliant 247,000-square-foot facility located in Kirkland, Québec,
DRAXIS Pharma manufactures pharmaceutical products for DRAXIMAGE, as well as
for over 26 other pharmaceutical clients in many international jurisdictions.
Key business development transactions involving
DRAXIS Pharma have included:
·
May 1998
$11.1 million acquisition of DRAXIS Pharmas pharmaceutical manufacturing
facility.
·
July 1999
signing of a five-year manufacturing supply agreement with Warner-Lambert
Canada Inc. (which then became known as Pfizer Consumer Healthcare, a division
of Pfizer Canada Inc.). In September 2005,
the Company announced that Pfizer Canada had renewed this agreement for a three
year term effective January 1, 2005.
The agreement was subsequently renewed for a one-year period ending December 31,
2008. The parties are presently
negotiating a possible renewal of the agreement. On December 20, 2006, DRAXIS Pharma was
advised that Johnson & Johnson, Inc. (J&J) had purchased
Pfizers consumer healthcare business and that the agreement had been assigned
to J&J.
·
February 2000
sale of 34.1% equity interest to SGF and DRAXIS Pharma senior management for
net proceeds of $5.4 million.
·
December 2001
signing of a long-term manufacturing and supply agreement for the renewal and
expansion of DRAXIS Pharmas existing contract manufacturing relationship with
GSK.
·
March 2003
initiation of production under a manufacturing and supply agreement with Bone
Care International, Inc. (now Genzyme) for Hectorol® Injection.
·
April 2004
acquisition by the Company of SGFs 32.7% interest in DRAXIS Pharma and
repayment of $3.1 million (CDN$4.2 million) in debt owed by DRAXIS Pharma to
SGF and $1.7 million (CDN$2.3 million) in debt owed by DRAXIS Pharma to
Investissement Québec. The DRAXIS Pharma
senior management interest was also bought so that the Company became the sole
shareholder of DRAXIS Pharma.
·
September 2007
the
Company announced it had expanded its existing contract manufacturing
relationship with JJC and entered into a new definitive supply agreement
23
to manufacture
a broad portfolio of multiple non-sterile specialty semi-solid products
currently marketed in the United States.
In 2004, we completed a three-year, $12 million capital plan at DRAXIS
Pharma, including the installation of a second lyophilizer. The capital plan also included new sterile
manufacturing capabilities to support recently announced contracts,
improvements to production line efficiency, improvements to infrastructure, new
raw material handling facilities and support systems to maintain the DRAXIS
Pharma facility at the forefront of regulatory compliance.
DRAXIS Pharmas three-year, $12
million capital plan was initially financed through
loans
and equity investment from DRAXIS Pharmas shareholders, loans from
Investissement Québec
and internally
generated funds. The equity was
repurchased and the loans were repaid in April 2004 from the proceeds of
the Companys public offering.
Since DRAXIS acquired DRAXIS Pharma, DRAXIS Pharmas revenues have risen
from $6.1 million for the eight-month period ended December 31, 1998 to
$54.9 million for the year ended December 31, 2007.
DRAXIS Pharmas business goal is to be a leading supplier of
high-value-added, high-margin contract pharmaceutical manufacturing
services. Key components of DRAXIS
Pharmas strategy to achieve this goal include:
·
obtaining and
maintaining all required regulatory approvals for DRAXIS Pharmas manufacturing
facility;
·
securing
additional manufacturing contracts with existing and new customers;
·
focusing on
DRAXIS Pharmas distinctive capabilities in sterile and lyophilized product
manufacturing;
·
providing
manufacturing and related services to DRAXIS other businesses; and
·
focusing on
operational excellence, including regulatory compliance, cost-effectiveness and
customer service.
24
Overview of Pharmaceutical Contract Manufacturing
In a report prepared by TD Newcrest, a Division of
TD Securities Inc. (Equity Research) and dated July 26, 2005 entitled
DRAXIS Health Initiating Coverage, it was estimated that the secondary, or
dosage-form, manufacturing portion of the $550 billion global pharmaceutical
market was $65 billion, with approximately $10 billion of that being
outsourced. Since 2005, we believe that
the contract manufacturing market for pharmaceuticals has continued to grow.
The reasons pharmaceutical companies outsource
manufacturing include:
·
productivity benefits plant utilization rates in the pharmaceutical
industry are declining and have created increased need to lower operating
costs;
·
moving assets off the balance sheet contract manufacturers are a
solution to high levels of industry assets tied up in under-utilized
facilities;
·
leveraging external expertise third-party contractors provide a
logical route to specialist services and access to updated technologies; and
·
pharmaceutical industry consolidation continuing mergers will likely
force rationalization of manufacturing capacity.
The Company believes that there is currently a significant global demand
for sterile lyophilization capacity and that this sector offers significantly
higher margin growth potential for DRAXIS Pharma due to its technical
complexity and its increasing demand as a favored dosage form for biotechnology
products in particular.
DRAXIS Pharma believes that the key competitive factors in the contract
manufacturing industry include the reliability of supply, quality of product,
strict compliance with governmental regulations, capacity availability,
competitive pricing and the technical and manufacturing ability to produce a
full range of quantities from small pilot batches often required for clinical
trials to larger commercial quantities.
Competition
DRAXIS Pharma competes with pharmaceutical companies that have in-house
manufacturing capabilities as well as with third-party contract manufacturers,
including Hospira Inc., Boehringer Ingelheim GmbH, Catalent Pharma Solutions
Inc., Hollister-Stier Laboratories LLC, DPT Laboratories Ltd, Haupt Pharma AG,
Patheon Inc. and DSM Pharmaceuticals, Inc.
Manufacturing Capabilities
DRAXIS Pharma is a customer-driven pharmaceutical contract manufacturing
division that is positioned to manufacture a variety of dosage forms. DRAXIS Pharma is one of a few existing
full-scale pharmaceutical contract manufacturing facilities in Canada that has
FDA-approved sterile manufacturing and sterile lyophilization capabilities.
In 2006 and 2007, the organization of this contract manufacturing
business was further refined as we implemented separate business unit
accountability for sterile and non sterile product operations to achieve a
flatter, more responsive organization.
Plant operations at our sole manufacturing facilities in Kirkland,
Québec are further organized into four manufacturing areas, supported by
packaging and warehousing and distribution functions.
25
Sterile
Lyophilization
Lyophilization is the preferred dosage form for a broad range of sterile
products that are unstable in liquid form.
Lyophilization is a complex process of freeze-drying in which a liquid
solution is frozen under vacuum and all water is removed, leaving behind a
stable, dry, sterile powder that has a relatively long shelf life and is easily
reconstituted into a liquid form prior to use.
Products delivered in a lyophilized dosage form include injectable
pharmaceuticals, vaccines, biotechnology proteins or peptides and diagnostic
products.
DRAXIS Pharmas existing sterile manufacturing capabilities were
enhanced by the addition of sterile lyophilization, which became fully
operational and approved by the FDA in the latter half of 2001. This fully automated line includes a vial
washer, a depyrogenation tunnel, an in-line filling machine, robot loaders and
unloaders, the freeze-drier unit and a capper.
This first freeze-drier has a capacity based on 11 square meters (120
square feet) of shelf space, while the second unit installed in 2004, with 24
square meters (254 square feet) of shelf space, has double the shelf space.
In 2004, the
Company completed a three-year, $12 million capital plan for DRAXIS Pharma,
including the addition of the second lyophilizer, new sterile manufacturing
capabilities to support recently announced contracts, improvements to
production line efficiency, improvements to infrastructure, new raw material
handling facilities and supporting systems to maintain DRAXIS Pharma at the
forefront of regulatory compliance.
The second
lyophilizer was incorporated into DRAXIS Pharmas existing lyophilization
facility. The specialized facility was
originally designed to readily accommodate this second lyophilizer at a cost
significantly less than that of the initial installation with minimal
disruption to ongoing production.
The second lyophilization unit completed validation
and began commercial production during 2005.
At optimum configuration and given the appropriate mix of lyophilization
cycles, the second lyophilizer could potentially allow us to approximately
triple existing lyophilization capacity over time. We did not achieve full capacity utilization
of the new lyophilizer in 2007; however the transfer of some current products
and the introduction of new products will continue to occur in 2008 and beyond.
Other
Sterile Products
The Sterile Products Department (SPD) includes preparation and
pharmaceutical areas with manufacturing, filling and inspection rooms for the
manufacture of injectable liquids, ophthalmic and otic products. We believe that DRAXIS Pharma possesses one
of the most modern facilities of its kind in Canada approved for the
manufacture of sterile prescription pharmaceuticals for Canada, the United
States and other global markets.
Including the new lyophilization line, SPD covers approximately 17,100
square feet and is designed for segregated operations complemented by secure
access controls.
Computerized systems are utilized for both topical and automated
ointment lines in order to optimize process control. Both of these lines are closed-loop systems
to ensure sterile integrity. The sterile
ointment system utilizes an automated system to place tubes on the fillers,
thereby minimizing human intervention.
The processes that are incorporated in the operation include aseptic
manufacturing and filling, terminal sterilization, clean in place (CIP), and
sterilize in place (SIP). The dosage
forms/product
26
types manufactured include solutions in
ampoules and vials, suspensions and solutions in drop dose form and ointments
in tubes. The department currently has
the capacity to fill vials ranging in size from 1 ml to 30 ml, ampoules ranging
in size from 1 ml to 10 ml, and 3.5 g to 4.5 g tubes.
Ointments,
Creams and Liquids
The 17,420-square-foot Ointments, Creams and Liquids (OCL) Department
offers substantial flexibility in production scale. Production of ointments and creams utilizes a
gravity-fed system and incorporates segregated wash areas and clean storage
areas for equipment.
Batch capability in the OCL Department varies from 200 to 18,000 liters
and incorporates three dedicated packaging lines. Interconnecting tanks can be utilized where
required, thereby providing production flexibility. Fully automatic validated CIP systems ensure
the purity of each customers product.
Product is pumped to two of the packaging lines and gravity fed to the
other two lines. Dosage forms/product
types manufactured include creams, ointments, lotions, syrups, shampoos, gels
and suspensions.
During 2007, capacity in the OCL Department was increased by nearly
fifty percent (50%) to accommodate the manufacturing of additional products
under a new contract with JJC for a broad portfolio of non-sterile specialty
semi-solid products, which was announced in September of 2007.
Solid
Dosage
The Solid Dosage Department covers approximately 10,300 square feet of
space and is comprised of two suites for granulating powders prior to
compression plus four isolated compression suites in which the powders are
pressed into tablets and caplets of various forms and sizes. The first granulation suite is designed for
large-batch blending, granulating and drying, while the second granulation
suite is equipped with smaller scale equipment that can be used for small
production or pilot batches.
Each granulation and compression suite has its own testing equipment and
cleaning area. The rooms are isolated
and have purpose-built airflow systems to contain powder.
Dosage forms and product types manufactured in this department include
tablets in bottles and blisters, caplets in bottles and blisters, and powders.
Packaging
The Packaging Department covers approximately 51,000 square feet and
incorporates an open space with movable separations that provide flexibility in
the packaging area featuring several packaging lines. Segregated zones are defined for de-boxing,
filling and secondary packaging. Bar
coding ensures complete control of all packaging components.
Within the department there are packaging lines for ointments and
creams, a line for liquid packaging, lines for tablets (bottles and blisters),
a sterile product packaging line which includes automatic inspection and a line
dedicated for lyophilized products and topical packaging. The inspection of finished sterile products
in glass ampoules includes automated inspection by a leak pinhole
detector. An automatic inspection
machine has been validated to detect particles in sterile products packaged in
vials and ampoules. These products may
also be inspected manually.
During the second half of 2007, construction was initiated on a second
facility in Ste-Anne-de-Bellevue, within 10 miles of the current facility in
Kirkland, Québec. This new facility will
be leased
27
from the developer and will initially be
dedicated to secondary packaging and warehousing of products and components
related to the new contract signed in September 2007 with JJC for the
manufacture of a broad portfolio of non-sterile specialty semi-solid
products. This additional packaging
facility is expected to be completed during 2008 and operating prior to the
start of commercial production under the contract with JJC, which is scheduled
for the beginning of 2009.
Regulatory
The manufacturing of our existing and potential products are subject to
regulation and approval by the TPD of the HPFBI and other authorities in Canada
and by numerous federal, state and local government authorities in the United
States, including the FDA. Similar
regulatory requirements exist in Europe and other countries.
Manufacturing operations at DRAXIS Pharma, from receipt of raw materials
and packaging ingredients, through compounding, dosage form processing,
filling, labeling and packaging, to final product release by quality control,
are all conducted in accordance with cGMP requirements and other appropriate
international regulatory standards.
Regular inspections of facilities, production processes, and control and
validation systems, as well as employee training programs, are conducted by
DRAXIS Pharma, by U.S., Canadian and international governmental regulatory
agencies and by customer inspection teams throughout the year. DRAXIS Pharma maintains a distinct internal
team to provide effective liaison with various external inspection groups.
DRAXIS Pharma has a strong regulatory track record. This includes 16 successful audits of our
facilities in 2007 (3 regulatory inspections and 13 client audits) and 13
successful audits of our facilities in 2006 (0 regulatory inspection and 13
client audits).
Warehousing and Distribution
The warehousing and distribution facilities at DRAXIS Pharma at our
facilities in Kirkland, Québec, allow additional manufacturing flexibility and
efficiency. A five-tier pallet-racking
warehouse has a full height of 29 feet, covers approximately 48,900 square feet
of space and has six shipping and receiving docks. The warehouse has separately locked areas,
including refrigeration units to control sensitive raw materials and finished
goods.
DRAXIS Pharma also
has a raw material storage and dispensing area, which provides an improved
environment for the handling and accurate dispensing of raw materials. This
installation improves the flow of material and personnel.
Customers
Third-Party
Contract Manufacturing
DRAXIS Pharma manufactures prescription and non-prescription
pharmaceutical products for more than 26 pharmaceutical companies (excluding
inter-company manufacturing) pursuant to manufacturing supply contracts. Such contract manufacturing services
represented 69.7% of our consolidated revenues for the year ended December 31,
2007. A significant portion of this
contract manufacturing business is focused on our three largest customers, GSK,
Genzyme and Johnson & Johnson Inc. (including JJC) which together
represented 45% of our consolidated revenues in 2007. See Risk Factors Risks Related to our
Company A Significant Portion of our Business is Dependent on a Small Number
of Key Customers.
28
In April 2002, DRAXIS Pharma entered into an agreement with Bone
Care International, Inc. (now Genzyme) to produce Hectorol® Injection for sale in the U.S., and we began
commercial shipments of the sterile injectable product in March 2003. A manufacturing and supply agreement was
signed on March 3, 2003. The agreement
is for a five-year term and was automatically renewed at the end of its term
for a one year period to March 2009.
The contract requires either party to give written notice of non renewal
to the other party one year prior to the end of the term or the end of a
renewal period. To date, the Company has
not received notice of non renewal.
O
n December 18,
2001, DRAXIS Pharma finalized supply and related agreements with GSK for the
renewal and expansion of an existing contract manufacturing relationship
between the companies. The products
transferred to DRAXIS Pharma were all established, sterile products marketed by
GSK in multiple international markets.
In 2002, a prescription sterile injectable product for the U.S. market
was added under this contract and commercial production of this product
commenced in the second quarter of 2002.
During 2002, site transfer and related activities associated with the
other GSK products were undertaken and production started in the second quarter
of 2003 and ramped up through 2003 and 2004 with full production of all
products achieved by the end of 2004.
DRAXIS Pharma will manufacture the products covered by the agreement
until it receives a termination notice from GSK which may be given by a
two-year advance written notice given on or after December 31, 2007. To date, the Company has not received any
termination notice.
On July 1, 1999, DRAXIS Pharma entered into a five-year
manufacturing and supply agreement with Warner-Lambert Canada Inc. (which then
became known as Pfizer Consumer Healthcare, a Division of Pfizer Canada Inc.)
covering several non-prescription products for the Canadian market, including
Polysporin®, Sudafed® and Actifed®.
Manufacturing of these products commenced in early 2000. On September 1, 2005, DRAXIS announced
it had renewed its agreement with Pfizer Canada for a three-year term,
effective January 1, 2005. On December 20,
2006, DRAXIS Pharma was advised that J&J had purchased Pfizers consumer
healthcare business and that the agreement had been assigned to J&J. The agreement was subsequently renewed for a
one-year period ending December 31, 2008.
During the third quarter of 2007, the Company announced it had expanded
its existing contract manufacturing relationship with JJC and entered into a
new definitive supply agreement to manufacture a broad portfolio of multiple
non-sterile specialty semi-solid products currently marketed in the United
States. This new multi-year contract
runs to the end of 2013 and may be extended beyond that date. It includes
approximately two years of manufacturing site transfer and process validation
activities followed by five years of commercial production, that is scheduled
to begin in 2009. We expect commercial production to generate incremental
revenues in excess of $120 million over the five year period of 2009 through
2013. The transfer of equipment and production technologies, currently in
progress, is expected to generate additional cumulative revenues during 2007
and 2008 of approximately $6 million to $8 million. In 2007, revenues of $2.6 million were
generated from this contract. A copy of
the supply agreement is filed as Exhibit 4.68 to this Annual Report (Form 20-F).
In connection with the supply agreement with JJC, DRAXIS Pharma also
signed a credit agreement with Johnson & Johnson Finance Corporation
(JJFC) as of September 4, 2007 which provides that JJFC shall provide
credit facilities of up to $12.2 million.
The credit facilities will be used by DRAXIS Pharma solely to finance
the acquisition and installation of equipment and to finance the cost of
transfer of the technology required for the pre-validation work in support of
the manufacture by DRAXIS Pharma of the products under the supply
agreement. A copy of the credit
agreement is filed as Exhibit 4.69 to this Annual Report (Form 20-F).
29
Inter-Company
Beginning in early 2002, DRAXIS Pharma became the FDA-approved
manufacturing site for DRAXIMAGEs lyophilized Tc-99m kits. In addition, DRAXIS Pharma has been qualified
as the manufacturing site for
ANIPRYL®
tablets.
Employees
As at December 31, 2007, DRAXIS Pharma had 389 employees
(representing approximately 78% of the Companys employees), consisting of: 51
managerial employees, 54 clerical employees, 62 quality operations employees,
17 technical employees and 205 unionized hourly employees. The unionized hourly employees are
represented by the United Food & Commercial Workers International
Union, Local 291 (AFL-CIO). A collective
agreement with a five-year term to April 30, 2008 was ratified in February 2004. DRAXIS Pharma currently has no significant
unresolved issues with the union and is presently preparing to negotiate a new
collective agreement with the union. See
Risk Factors Risks Related to our Company Our Business Could be Harmed if
there were a Dispute or Disruption with our Unionized Employees.
Former Equity Partners
From February 2000 to April 2004, SGF and senior management of
DRAXIS Pharma held a non-controlling equity interest in DRAXIS Pharma Inc. In 2002 and 2003, DRAXIS Pharma Inc. (now
known as DRAXIS Pharma, a division of DRAXIS Specialty Pharmaceuticals Inc.)
repurchased and cancelled shares held by a former DRAXIS Pharma employee and
members of DRAXIS Pharmas management team in exchange for cash and settlement
of existing loans. In April 2004,
the Company acquired from SGF its 32.7% interest in DRAXIS Pharma and also
repaid $3.1 million (CDN$4.2 million) in debt owed by DRAXIS Pharma to
SGF. The DRAXIS Pharma senior management
interest was also bought at that time so that the Company became the sole
shareholder of DRAXIS Pharma.
Radiopharmaceuticals
Radiopharmaceuticals accounted for 29.4% of our consolidated revenues
for the year ended December 31, 2007.
Our DRAXIMAGE division is responsible for discovering, developing,
manufacturing, and marketing our diagnostic imaging and therapeutic
radiopharmaceutical products for the global nuclear medicine marketplace. Nuclear medicine entails the use of radioactive
drugs (radiopharmaceuticals) for imaging and therapeutic purposes. The energy released as these products decay
can be harnessed to: (i) elicit a
visual representation of various organs and tissues (nuclear imaging); or (ii) destroy
cancerous cells (radiotherapy). Products
currently marketed by DRAXIMAGE include a line of lyophilized Technetium Tc-99m
kits (Tc-99m) used in nuclear imaging procedures and a line of imaging and
therapeutic products labeled with a variety of isotopes, including iodine.
As announced on February 2, 2007, DRAXIMAGE submitted an ANDA to
the FDA for its generic kit for the preparation of Tc-99m Sestamibi for
injection (DRAXIMAGE
Ò
Sestamibi), a nuclear
medicine imaging agent used in myocardial perfusion imaging (MPI) to evaluate
blood flow to the heart in patients undergoing cardiac tests. On July 7, 2007, the Company was
informed by the FDA that its ANDA submission was acceptable for filing. On July 25, 2007, DRAXIMAGE announced it
had filed DRAXIMAGE
Ò
Sestamibi with European
regulatory authorities. The Company also
filed an Abbreviated New Drug Submission (A/NDS) for DRAXIMAGE
Ò
Sestamibi on August 17,
2007 with Health Canada. On October 11,
2007, the Company was informed by Health Canada that this submission had been
screened and found acceptable for review.
See Risks Factors Risks related to our industry
30
We may not be able to get timely regulatory approval
for our products and we must comply with regulatory requirements to manufacture
and market our products.
According to BIO-TECH SYSTEMS, in 2007 there were 8.3 million nuclear
cardiology procedures (out of 17.5 million total nuclear procedures) in the
U.S.A. Sales of nuclear cardiology
products were $1,291.6 million in 2007 (67.0% of total diagnostic
radiopharmaceutical sales). Sales of
Cardiolite
Ò
, the largest
single revenue producer, were $360.7 million (55% of cardiology perfusion
sales) followed by Myoview
Ô
with sales of $202.3 million
(31% of cadiology perfusion sales).
Cardiolite
Ò
is the product
of Lantheus Medical Imaging (formerly Bristol-Myers Squibb Imaging). Myoview
Ô
is the product
of GE Healthcare.
Once DRAXIMAGE
Ò
Sestamibi is approved,
DRAXIMAGE plans to enter the MPI market after the key patent for the currently
marketed Tc-99m Sestamibi product expires, which is expected to be in 2008 for
the United States, 2009 for Canada and from 2007 and onwards in various
European countries, and after it receives regulatory approval for the sale of DRAXIMAGE
Ò
Sestamibi.
DRAXIMAGE also has
a number of other products in development. DRAXIMAGE has received approval in November 2006
from the FDA to run two clinical trials in the U.S. using radioactive
Iobenguane I-131 Injection (also known as 131 I-metaiodobenzylguanidine, or
I-131 MIBG) to treat high-risk neuroblastoma, a rare form of cancer that
affects mostly infants and young children.
Given the inherent uncertainties associated with new drug development,
it is difficult to predict if, or when, this product will achieve
commercialization.
DRAXIMAGE is developing
MOLY-FILL
Ô
, a next-generation version of a
Technetium Tc-99m Generator, which is the source of Technetium Tc-99m in
virtually every radiopharmacy worldwide.
According to the Bio-Tech Systems Report 270 (issued in
November 2007), entitled The U.S. Market for Diagnostic
Radiopharmaceuticals, the generator market in the United States is currently
estimated at approximately $166.7 million and is growing at approximately 5%
annually. Nearly 85% of generators are
located in radiopharmacies and the rest are in other institutions such as
hospitals and clinics.
Technetium (Tc-99m) is
one of the most widely used radiopharmaceuticals. Due to its short half-life,
it has to be produced on site or nearby by generators shipped with a longer
half-life mother isotope, the molybdenum (Mo99). In other words, generators are used to
produce technetium on site at the hospital or radiopharmacy. A generator
consists of a column loaded with Mo99, encased within lead shielding designed
to provide protection from radiation. It
can typically provide Tc 99m for a period of approximately one week, depending
on the degree of usage by the radiopharmacy.
During the fourth quarter of 2007, the Company completed a test evaluation
of the prototype version of this product and the results of the evaluation will
contribute to the continuing product development process. DRAXIMAGE is in discussions with potential
development, marketing and manufacturing partners for its MOLY-FILL
Ô
generator.
See Risk Factors Risks Related to our Industry If the Market Does
Not Accept our Products Currently in Development, our Business Could Be
Harmed.
Founded in 1950 as a division of Charles E. Frosst & Co., the
predecessor business to DRAXIMAGE pioneered and became a leader in the medical
application of nuclear technology after assuming the development function from
Atomic Energy of Canada Ltd. Following
the 1965 acquisition of Charles E. Frosst & Co. by Merck Inc.
(Merck), the business continued operations as a division of Mercks Canadian
subsidiary, Merck Frosst Canada and Co. (Merck Frosst), until its acquisition
by
31
DRAXIS in 1997.
As part of the acquisition, the Company retained all of the businesss
managers, scientists and employees as well as its existing products and
intellectual property.
The acquisition of this business was consistent with our strategy of
acquiring specialty pharmaceutical platforms with potential for expansion into
global markets. We believe that DRAXIMAGE is one of the few companies that
manufacture I-131 radiopharmaceutical products in Canada.
DRAXIMAGE and its predecessor have a long history of technological and
scientific progress in the field of radiopharmaceuticals. Notable achievements include the development
of lyophilized kits for the in-situ preparation of Technetium Tc-99m
radiopharmaceutical products for nuclear medical imaging (Tc-99m kits); the
development of chelates for the indium/yttrium and Technetium/rhenium groups of
metals; and the development of stabilizers for use in iodinated
radiopharmaceuticals, which resulted in DRAXIMAGE being one of the few
providers to market iodinated products that do not require refrigeration.
Key business development transactions involving DRAXIMAGE have included:
·
July 1997
$8.6 million acquisition of the Canadian radiopharmaceutical division of Merck
Frosst, which began operations through DRAXIMAGE Inc. (now known as DRAXIMAGE,
a division of DRAXIS Specialty Pharmaceuticals Inc.).
·
October 1999
licensing from Isogenic Science Ltd. (Isogenic) of the rights to Isogenics
proprietary technology related to radioactive brachytherapy implants (
BrachySeed
®
) for the treatment of various localized
cancers.
·
July 2000
signing of a non-exclusive distribution agreement with Syncor International
Corporation (now known as Cardinal Health 414, LLC) for the production of a kit
for the preparation of Sodium Iodide I-131 Capsules and Oral Solution indicated
for the treatment of thyroid cancer and hyperthyroidism for sale in the U.S.
·
December 2000
entering into license, distribution and supply agreements for
BrachySeed
®
for the U.S. market with Cytogen
Corporation. In April 2003, this
license was terminated.
·
March 2001
licensing from BTG International Limited (formerly known as the British
Technology Group) of the rights to
INFECTON
®
, an agent for
imaging infection. In November 2007,
DRAXIMAGE announced it would discontinue all work related to
INFECTON
Ò
.
·
October 2001
long-term third-party manufacturing agreement to supply Bracco Diagnostics
Inc. with sodium iodide I-131 radiotherapy capsules for the U.S. market.
·
May 2003
expansion of agreements with Isogenic for global rights to proprietary
technology related to brachytherapy implants.
November 2005 DRAXIMAGE announced it would discontinue the
manufacture and sale of implantable brachytherapy seeds as of December 15,
2005.
·
July 2003
extension and expansion of strategic partnership with Bristol-Myers Squibb
Canada Co. (Bristol-Myers Canada) for the marketing and distribution of
32
radiopharmaceutical products in Canada. This agreement was terminated as of
December 31, 2007.
·
August 2003
amendment to the July 2000 agreement with Cardinal Health 414, LLC to
enable DRAXIMAGE to distribute the new radioactive Iodine I-131 kit product to
independent radiopharmacies in the U.S.
·
February 2005
announcement
that DRAXIMAGE had received approval from the Dutch regulatory
authority for its kit for the Preparation of Technetium Tc-99m Albumin
Aggregated Injection (MAA Kit). This
approval allowed DRAXIMAGE to initiate the Mutual Recognition Procedure (MRP)
in pursuit of further regulatory approvals for the diagnostic imaging product
in additional European Union countries.
·
April 2005
announcement of the appointment of Mr. Jean-Pierre Robert as the new
President of the DRAXIMAGE division.
·
January 2006
DRAXIMAGE announced it had received approval from the FDA for its
supplemental new drug application for Sodium Iodide I-131 Capsules USP,
Diagnostic-Oral.
·
November 2006
DRAXIMAGE announced it had been approved by FDA to run two clinical trials
using radioactive Iobenguane I-131 Injection (also known as I-131
metaiodobenzylguanidine or I-131 MIBG) to treat high risk neuroblastoma, a rare
form of cancer that affects mostly infants and young children.
·
February 2007
DRAXIMAGE announced it had submitted an ANDA to the FDA for its generic kit
for the preparation of DRAXIMAGE
Ò
Sestamibi. On July 7, 2007, the Company was
informed by the FDA that its ANDA submission was acceptable for filing.
·
On July 25,
2007, DRAXIMAGE announced it had filed DRAXIMAGE
Ò
Sestamibi with
European regulatory authorities.
·
The Company also
filed an Abbreviated New Drug Submission (A/NDS) for DRAXIMAGE
Ò
Sestamibi on August 17,
007 with Health Canada. On October 11,
2007, the Company was informed by Health Canada that this submission had been
screened and found acceptable for review.
·
December 2007
DRAXIMAGE appointed GE Healthcare as the exclusive distributor of DRAXIMAGE
Ò
Sestamibi in the
United States. DRAXIMAGE granted GE Healthcare the exclusive right to market,
distribute and sell its generic DRAXIMAGE
Ò
Sestamibi in the
U.S. market and through its U.S. and Canadian radiopharmacy network once the
primary innovator patent expires and marketing authorizations are received from
the FDA and Health Canada. Furthermore,
GE Healthcare agreed to purchase Technetium 99m Sestamibi injections
exclusively from DRAXIMAGE. The initial
term of the distribution agreement is for a minimum of three years following
FDA approval of the DRAXIMAGE
Ò
Sestamibi.
DRAXIMAGEs growth strategy is to leverage its history and experience in
the research, development, manufacture and distribution of radiopharmaceutical
products and services and to capitalize on its manufacturing capabilities. In particular, DRAXIMAGEs business strategy
includes:
33
·
Increasing the
market penetration of its radioactive products, particularly in the U.S.;
·
Increasing
international sales of its key Tc-99m kits and Iodine I-131 products,
particularly in Europe, but also in other global markets;
·
Timely,
cost-effective development of its portfolio of proprietary, innovative imaging
and therapeutic radiopharmaceutical products; and
·
Identifying and
capitalizing on additional new business opportunities and strategic
partnerships which are consistent with DRAXIMAGEs capabilities, including the
monitoring of products that will come off patent protection in key markets that
can be manufactured, marketed and sold by DRAXIMAGE and monitoring products
that are owned by third parties and which could be divested in the consolidation
that is taking place in the radiopharmaceutical industry.
Overview of Radiopharmaceuticals
The medical specialty of nuclear medicine involves the use of
short-lived radioisotopes for both diagnostic imaging and therapeutic
applications. Pharmaceutical products
used in such applications are commonly called radiopharmaceuticals. Radiopharmaceuticals represent a
well-defined, growing niche market that involves challenges such as regulatory
approvals, specialized manufacturing standards, access to supply and critical
delivery logistics.
Diagnostic Imaging Applications
The diagnostic imaging applications of nuclear medicine normally involve
the intravenous administration of a radiopharmaceutical consisting of a
targeting molecule, which has a particular binding affinity for a specific
organ or tissue linked to a low intensity, short-lived, gamma-emitting
radioisotope such as Tc-99m. Following
administration, the radiopharmaceutical with its radioactive isotope concentrates
at the biological target, which is then imaged using a scanning device such as
a gamma camera. A gamma camera consists
of a scintillation crystal which, when placed over a region of the body, is
capable of detecting gamma rays emitted by radionuclides in underlying
tissues. The gamma camera and its
associated computerized peripheral devices accurately measure the radiation
being emitted by the radioisotope and so provide both a visual picture of the
target and quantitative data concerning the distribution of radioactivity.
A nuclear medicine image provides both static and functional, or
dynamic, information about a biological target, thereby revealing functional
and morphological information normally unobtainable by other imaging techniques
such as X-ray, magnetic resonance imaging, computer tomography, and ultrasound,
all of which provide primarily anatomical information.
Nuclear medical imaging procedures are established and trusted medical
procedures with many years of safe and effective use. Most procedures are non-invasive, are performed
with a minimum of discomfort and inconvenience to the patient and are normally
less costly and involve less risk than other currently available high-tech
alternative techniques.
34
Therapeutic
Applications
Increasingly, therapeutic radiopharmaceuticals are being used and new
products are being developed for the treatment of disease, particularly for the
treatment of various cancers. Examples
of currently marketed therapeutic radiopharmaceuticals include:
·
various sodium
iodide I-131 products for the diagnosis and treatment of thyroid cancer and
hyperthyroidism;
·
phosphorous-32
for the palliative treatment of bone pain for patients with advanced metastatic
bone cancer; and
·
I-131
meta-iodobenzylguanidine (MIBG) for the treatment of neuroblastoma.
New generations of anti-cancer agents based on targeting molecules such
as peptides, proteins, metabolites and monoclonal antibodies that have binding
affinities to the surface of cancerous cells are being developed to be linked
to more potent, higher-intensity, beta-emitting radioisotopes such as
yttrium-90, rhenium-186, holmium-166 and lutetium-199. There is a growing body of scientific
evidence that molecules, thus bound, will permit the delivery of therapeutic
quantities of radiation directly to malignant cells.
Competition
The radiopharmaceutical field is highly specialized, particularly in the
therapeutic area. Challenges include
meeting pharmaceutical product and nuclear regulatory requirements, having the
ability to handle radioactive materials and establishing facilities and
procedures to manufacture products in a sterile lyophilized or freeze-dried
form, which involves manufacturing standards higher than those typically
employed for most pharmaceutical products.
In addition, manufacturing and distribution logistics systems must be
well-integrated and supportive to ensure that radiopharmaceutical products can
be produced rapidly and delivered to the end user in a timely manner with the
prescribed level of strength.
Companies with significant radiopharmaceutical operations include
Lantheus Medical Imaging (formerly Bristol-Myers Squibb Imaging), GE
Healthcare, Covidien, CISbio, and Bracco S.p.A. In addition, there are a
number of companies that are developing and/or marketing other
radiopharmaceutical products, including MDS Nordion Inc., Immunomedics, Inc.,
IBA Molecular, Cytogen Corporation, International Isotopes Inc. and Molecular
Insights Pharmaceuticals, Inc.
Marketed Products
DRAXIMAGEs products are divided into two groups: (i) radioactive
products, particularly products containing radioactive iodine, which are in a
radioactive and ready-to-use form when shipped to customers, and (ii) non-radioactive
products (predominantly Tc-99m kits).
The non-radioactive kit products are sold in lyophilized (freeze-dried),
non-radioactive form consisting of sterile, pyrogen-free complexes of chemical
and/or biological substances. Tc-99m
kits are reconstituted with radioactive Tc-99m in the nuclear medicine
laboratory of a hospital or a unit-dose service supplier, or radiopharmacy,
prior to use.
35
Radioactive
Products
Radioactive products, which are shipped by DRAXIMAGE with the
radioactive isotope already incorporated, are distributed to the nuclear
medicine departments of hospitals or diagnostic clinics in a ready-to-use form.
The following table summarizes the DRAXIMAGE radioactive products. All products listed have received approval
for sale by the applicable regulatory body in the territory in which the
product is sold.
Product
|
|
Indication
|
|
Principal
Markets
|
Imaging Products
|
|
|
|
|
51
Chromate
Injection, USP
|
|
Measurement of blood volume
|
|
Canada
|
57
Co-Cyanocobalamin
Capsule USP
|
|
Diagnosis of Vitamin-B
12
malabsorption
|
|
Canada
|
57
Co-Standard
Cobalt Reference Solution
|
|
Reference for
57
Co-Cyanocobalamin
|
|
Canada
|
111
In-Diethylene
Triamine Pentacetic Acid Injection (DTPA)
|
|
Cisternography
|
|
Canada
|
111
In-Indium
Chloride Sterile Solution
|
|
Labeling of peptides and
antibodies
|
|
Canada
|
131
I-Sodium Iodide
Diagnostic Capsules, Oral
|
|
Imaging of thyroid disorders
|
|
Canada/U.S.
|
131
I-Sodium Iodide
Diagnostic Solutions, Oral
|
|
Imaging of thyroid disorders
|
|
Canada
|
131
I-meta-iodobenzylguanidine
|
|
Adrenal imaging
|
|
Canada
|
125
I-Iodinated
Albumin Injection, USP
|
|
Measurement of blood and
plasma volume
|
|
Canada
|
133
Xe-Xenon Gas
|
|
Lung ventilation studies
|
|
Canada
|
|
|
|
|
|
|
|
|
|
|
Therapeutic Products
|
|
|
|
|
131
I-Sodium Iodide
Therapeutic Solutions, Oral and Intravenous
|
|
Treatment of thyroid disorders
|
|
Canada
|
131
I-Sodium Iodide
Therapeutic Capsules Oral
|
|
Treatment of thyroid
disorders
|
|
Canada/U.S./ Denmark*
|
Kit for the Preparation of
Sodium Iodide I-131 Capsules and Solution USP Therapeutic Oral
|
|
Treatment of thyroid
disorders
|
|
U.S.
|
32
P-Sodium
Phosphate Solution, USP
|
|
Treatment of polycythemia
|
|
Canada
|
*This product is approved for sale in Denmark, however it is not
currently sold in that country as the Company is seeking distributors for same.
36
Sodium Iodide I-131 Radiotherapy
In October 2001, DRAXIMAGE entered into a third-party manufacturing
contract to supply sodium iodide I-131 radiotherapy capsules for Bracco
Diagnostics Inc. for the U.S. market for the treatment of thyroid cancer and
hyperparathyroidism.
In January 2003, DRAXIMAGE received FDA approval to produce and
market a new radiopharmaceutical kit product for the preparation of Sodium
Iodide I-131 Capsules and Oral Solution for the treatment of thyroid cancer and
hyperthyroidism. This was the first such
product on the market that allows physicians and radiopharmacists to prepare an
FDA-approved I-131 gelatin capsule or oral solution. In March 2003, DRAXIMAGE launched the
new kit product and initiated shipments to the Nuclear Pharmacy Services group
of Cardinal Health 414, LLC, under a five-year, non-exclusive distribution
agreement for the product for the United States and its possessions. As of 2003, this product was made available
to other customers and distributors in the U.S.
In November 2004, DRAXIMAGE received FDA approval for a DRAXIMAGE
Ò
brand of I-131
therapeutic capsules.
In November 2005, DRAXIMAGE announced it had received FDA approval
for a new larger format version of its I-131 kit for the preparation of Sodium
Iodide I-131 Capsules and Oral Solution.
DRAXIMAGE introduced this product in the U.S. market in January 2006.
In January 2006, DRAXIMAGE announced it had received approval from
the FDA for its supplemental new drug application for Sodium Iodide I-131 Capsules
USP, Diagnostic-Oral. These diagnostic
Sodium Iodide I-131 capsules are intended to be used by physicians to perform
the radioactive iodide (RAI) uptake test to evaluate thyroid function prior to
treatment with stronger therapeutic doses of Sodium Iodide I-131. Diagnostic doses of Sodium Iodide I-131 may
also be employed in localizing metastases associated with thyroid
malignancies. DRAXIMAGE introduced the
new diagnostic capsules into the U.S. market in May 2006.
Non-Radioactive
Products
DRAXIMAGE currently markets the following non-radioactive products. All
products listed have received approval for sale by the applicable regulatory
body in the territory in which the product is sold.
Product
|
|
Indication
|
|
Principal
Markets
|
Tc-99m
Kits
|
|
|
|
|
99m
Tc-MarcoAggregated
Albumin Kit (MAA)
|
|
Diagnosis of lung perfusion
|
|
U.S./Canada/ Netherlands/
Belgium/ Austria*/ Germany*/ UK*/ Luxembourg*
|
|
|
|
|
|
99m
Tc-Diethylene
TriaminePentacetic Acid Kit (DTPA) Stabilized with p-Aminobenzoic Acid
|
|
Diagnosis of kidney function,
blood pool imaging and lung ventilation function
|
|
U.S./Canada
|
|
|
|
|
|
99m
Tc-Calcium
Glucoheptonate Kit
|
|
Diagnosis of kidney function
|
|
U.S./Canada
|
37
Product
|
|
Indication
|
|
Principal
Markets
|
99m
Tc-MethyleneDiphosphonic
Acid Kit (MDP) Stabilized with p-Aminobenzoic Acid
|
|
Diagnosis of inflammatory and
neoplastic bone disease
|
|
U.S./Canada/ Netherlands/ UK*
|
99m
Tc-Calcium
Gluceptate Kit
|
|
Diagnosis of kidney function
and red blood cell imaging agent
|
|
Canada
|
*These Products
are approved for sale in these countries, however they are not currently sold
in these countries as the Company is seeking distributors for same.
Other
|
|
|
|
|
Intrinsic Factor Capsule
|
|
Use with
57
Co-Cyanocobalamin
|
|
Canada
|
DRAXIMAGEs major non-radioactive products are its MDP, DTPA and MAA
Tc-99m diagnostic imaging kits. While
these products would technically be classified as generic pharmaceutical
products, DRAXIMAGEs versions are proprietary and are sold under the DRAXIMAGE
Ò
trademark or
that of its local distributors. All
three of these products feature a proprietary formulation that provides
additional shelf life following reconstitution compared to competitive
products.
On October 25, 1995, Frosst Radiopharmaceuticals, a division of
Merck Frosst Canada Inc. (now known as DRAXIMAGE) entered into a non-exclusive
distribution agreement with Syncor International Corporation (now known as
Cardinal Health 414, LLC) for distribution in the U.S. of DTPA, a kit used to
prepare Tc-99m Pentetate to study kidney clearance, and MDP, a kit used to
prepare Tc-99m Methylene Diphosphonic Acid to study bone metabolism. The initial term was for five years, with
automatic renewal of the agreement for successive two-year periods.
Prior to 2002, DRAXIMAGE produced Tc-99m kits at its Merck Frosst
location. Following FDA approval of the
Companys new lyophilization production facilities in early 2002, the resulting
increased manufacturing capacity provided the opportunity to increase sales volumes
of these products in existing markets in the U.S. and Canada and to build new
markets in Europe and Asia, territories in which product approvals are either
already in place or expected to be granted in the near future.
In March 2004, DRAXIMAGE received approval from the FDA to produce
and market a new formulation of MDP, called MDP-25, a kit for the preparation
of Technetium Tc-99m Medronate Injection.
In September 2005, MDP-25 was approved by Health Canada.
Products under Development
As of March 18, 2008, DRAXIMAGE had the following products under
development:
Product
|
|
Status
|
|
Indication
|
Imaging Products
|
|
|
|
|
MOLY-FILL
Ô
Technetium
Tc-99m Generator
|
|
Development
|
|
Tc-99m for imaging
|
Therapeutic Products
|
|
|
|
|
I-131 MIBG
|
|
Phase I (U.S.)
|
|
neuroblastoma
|
38
Product
|
|
Status
|
|
Indication
|
Imaging Products
|
|
|
|
|
|
|
Phase II (U.S.)
|
|
|
The
clinical development of radiopharmaceutical imaging agents differs from that of
therapeutics in several areas. While therapeutics are developed to offer
improved efficacy and safety in the treatment of a specific disorder,
radiopharmaceutical imaging agents are elaborated for demonstrating the
existence and extent of a specific condition. Therefore the trial design for
establishing efficacy is not the same. In the case of radiopharmaceutical
imaging agents the endpoint is the actual image. The analysis is therefore
centered around various quantitative and qualitative aspects of the image. For
example, the image quality is assessed at various time points to determine the
time to best quality. Also a blinded read of images is conducted to determine
the accuracy as well as the sensitivity and specificity of the test in
comparison to the modality that is currently accepted as the gold standard. In
order for the test to be useful across clinical sites the inter-rater
reliability should also be high. This is an important endpoint that is measured
by a weighted Kappa test. These are the main efficacy considerations for
radiopharmaceutical imaging agents. The analysis of safety is similar to that
of therapeutic agents and includes the usual vital sign monitoring as well as
the capturing of side effects through adverse event reporting.
DRAXIMAGE
Ò
I-131 MIBG
Description - DRAXIMAGE
Ò
I-131 MIBG is used to treat
neuroendocrine (cardinoid) tumours, adrenal tumors (neuroblastoma in children
and phaechromocytoma) and on rare occasions it can be used to treat thyroid
cancer. Iobenguage is m-iodo-benzylguanidine
(MIBG), a guanethidine derivative structurally resembling
norepinephrine. There exists
extensive literature reports that indicate that I-131 MIBG has been used over
the last two decades as a therapeutic agent for the treatment of
pheochromocytoma, paraganglioma, neuroblastoma, carcinoid, and medullar thyroid
carcinoma. The diagnostic use of I-131 MIBG is approved in Europe, the
U.S. and Canada. The therapeutic use of I-131 MIBG is approved in Europe
but is investigational in the United States and Canada.
DRAXIMAGE manufactures the I-131 MIBG at its
facility.
Regulatory Status - DRAXIMAGE is providing I-131 MIBG for two clinical
trials approved by the FDA under an Investigational New Drug (IND)
application. One trial is a Phase II
study in which I-131 MIBG is being administered with intensive chemotherapy and
autologous stem cell rescue for high-risk neuroblastoma patients. The second trial is a Phase I study in which
irinotecan and vincristine, two common chemotherapy agents, are being administered
in combination with I-131 MIBG to determine safety and tolerability in patients
with resistant/relapsed high-risk neuroblastoma.
Both clinical trials are being coordinated by a group of eleven
childrens hospitals and two universities in the United States known as the New
Advances in Neuroblastoma Therapy (NANT) consortium. These two trials are continuations of earlier
NANT studies. The clinical trials
started early in 2007 and are currently ongoing. NANT member institutions are:
·
C.S. Mott
Childrens Hospital, University of Michigan Ann Arbor, MI
·
Childrens
Healthcare of Atlanta Atlanta, Georgia
·
Childrens
Hospital and Regional Medical Center Seattle, WA
·
Childrens
Hospital Boston, Dana-Farber Cancer Institute Boston, MA
·
Childrens
Hospital Los Angeles Los Angeles, CA
·
Childrens
Hospital Medical Center Cincinnati, OH
·
Childrens
Hospital of Philadelphia Philadelphia, PA
·
Childrens
Memorial Hospital Chicago, IL
39
·
Lucile Packard
Childrens Hospital Palo Alto, CA
·
Riley Hospital
for Children, Indiana University Indianapolis, IN
·
Texas Childrens
Cancer Center, Baylor College of Medicine Houston, TX
·
University of
California, San Francisco San Francisco, CA
·
University of
Wisconsin Comprehensive Cancer Center Madison, WI
Competing Therapeutic Products -
We also believe that AZEDRA
Ô
, being developed by Molecular Insight
Pharmaceuticals, Inc. (MIPI) may compete with our DRAXIMAGE
Ò
I-131 MIBG product under clinical
development. AZEDRA
Ô
has received Orphan Drug status and a Fast
Track designation by the FDA. According
to information set forth in its website, MIPI is conducting a Phase I dosimetry
study with AZEDRA
Ô
in adults at Duke
University. The initial target market
for AZEDRA
Ô
dosimetry study is the
treatment of metastatic neuroendocrine tumours such as pheochromocytoma,
carcinoid and neuroblastoma that are not amenable to treatment with surgery or
conventional chemotherapy. Metastatic
tumours are tumours that spread to other organs or parts of the body. Additionally, according to information set
forth in its website, MIPI initiated a Phase I/II study dose-finding and
therapeutic evaluation of the product in patients with malignant
Pheochromocytoma/Paraganglioma, which completion is expected for July 2012.
The primary objectives of this study are to determine the maximum tolerated
dose of the product and then, to determine the objective tumor response rate
nine months following treatment.
Technetium Tc-99m
Generators
DRAXIMAGE is
developing MOLY-FILL
Ô
, a next-generation version of a
Technetium Tc-99m Generator, which is the source of Technetium Tc-99m in
virtually every radiopharmacy worldwide.
According to the Bio-Tech Systems Report 270 (issued in November 2007),
entitled The U.S. Market for Diagnostic Radiopharmaceuticals, the generator
market in the United States is currently estimated at approximately $166.7
million and is growing at approximately 5% annually. Nearly 85% of generators are located in
radiopharmacies and the rest are in other institutions such as hospitals and
clinics.
Technetium (Tc
99m) is one of the most widely used radiopharmaceuticals. Due to its short
half-life, it has to be produced on site or nearby by generators shipped with a
longer half-life mother isotope, the molybdenum (Mo99). In other words, generators are used to
produce technetium on site at the hospital or radiopharmacy. A generator
consists of a column loaded with Mo99, encased within lead shielding designed to
provide protection from radiation. It
can typically provide Tc 99m for a period of approximately one week, depending
on the degree of usage by the radiopharmacy.
During the fourth quarter of 2007, the Company completed a test
evaluation of the prototype version of this product and the results of the
evaluation will contribute to the continuing product development process. DRAXIMAGE is in discussions with potential
development, marketing and manufacturing partners for its MOLY-FILL
Ô
generator.
Other
Development Products
SOMATOSCAN
®
/Somatostatin Therapy
Description -
SOMATOSCAN
®
and Somatostatin
Therapy are radiolabelled somatostatin peptides derived from a synthetic
peptide based on MK-678, originally developed by Merck, which shows a high
binding affinity for the somatostatin receptors expressed in neuroendocrine
tumors, lymphoma and carcinoid and small-cell lung cancer. This peptide may be developed as both a
diagnostic imaging agent (
SOMATOSCAN
®
) and therapeutic
product (Somatostatin Therapy) and we believe that it may permit the
40
identification and treatment of primary tumors
and the correct diagnosis of metastatic lesions. No substantial work related to
SOMATOSCAN
Ò
or Somatostatin
Therapy has been carried out since 2005.
Paclitaxel
Description - Paclitaxel is a novel, anti-tumor agent referred to in
some scientific and medical literature as taxol. Paclitaxel is currently marketed in the U.S.
under the brand name Taxol
Ò
by Bristol-Myers Squibb
Company. In January 1997, DRAXIS
acquired from Mylan Laboratories Inc. (Mylan) the exclusive Canadian
marketing rights to the Mylan formulation of paclitaxel. In June 1998, DRAXIS filed with the
HPFBI a New Drug Submission in Canada for paclitaxel, and the HPFBI has
completed its review process. Prior to
approval, DRAXIS must comply with Canadian Patented Medicines Regulations with
respect to generic competition. Mylan is
currently assessing the status of patent infringement litigation in Canada
regarding paclitaxel, and the Company has agreed to defer launch in Canada
until such issues have been clarified.
Under the agreement, DRAXIS and Mylan will share the profits from
marketing and selling paclitaxel in Canada according to a formula agreed to
between the parties.
Manufacturing
Radioactive
Products
DRAXIMAGE manufactures its radioactive products in its cGMP compliant
manufacturing facility located in Kirkland, Québec supported by a full quality
control department licensed by regulatory agencies in Canada and the U.S.
In 2001, DRAXIMAGE completed the expansion of its radiopharmaceutical
production area in anticipation of increasing sales volumes of its
radiopharmaceutical line in the U.S. and other markets. This expansion has approximately doubled the
size of the original facility to 19,000 square feet.
Most of the radioisotopes used to produce radiopharmaceuticals are
supplied to DRAXIMAGE primarily, but not exclusively, by MDS Nordion, a
subsidiary of MDS Inc. (NYSE: MDZ; TSX: MDS) and one of the worlds largest
supplier of chemical-grade isotopes for use as medical radioisotopes.
A key distinguishing characteristic of the radiopharmaceuticals business
is the need for a sophisticated logistics system. Radiopharmaceuticals, by their nature, decay
continually over time, thereby losing their potency. Therefore, manufacturing and product delivery
systems must be well coordinated to ensure that the level of radioactivity
present in the product supplied to the physician is correct at the time of administration.
Lyophilized
Products
DRAXIMAGEs Tc-99m kits are currently manufactured by DRAXIS Pharma in
its Kirkland, Québec facility, which was first accepted as a manufacturing site
by the FDA in October 2001.
Subsequent manufacturing site transfer approvals for the Tc-99m kits
were received during the period December 2001 to March 2002.
41
Regulatory
In the period December 2001 through March 2002, DRAXIMAGE was
approved by the FDA to transfer production of its line of lyophilized medical
imaging products in-house to the DRAXIS Pharma lyophilization production
facility.
In January 2003, DRAXIMAGE received FDA approval to produce and
market a new radiotherapeutic kit product for the preparation of Sodium Iodide
I-131 Capsules and Oral Solution.
In March 2004, DRAXIMAGE received FDA approval to produce and
market a new formulation of MDP called MDP-25, a diagnostic product for
preparing a skeletal imaging agent.
In November 2004, DRAXIMAGE received FDA approval for a DRAXIMAGE
brand of I-131 therapeutic capsules.
In September 2005, MDP-25 was approved by Health Canada but is not
currently sold by DRAXIMAGE.
In November 2005, DRAXIMAGE announced it had received FDA approval
for a new larger format version of its I-131 kit for the preparation of Sodium
Iodide I-131 Capsules and Oral Solution.
DRAXIMAGE introduced this product in the U.S. market in January 2006.
In January 2006, DRAXIMAGE announced it had received approval from
the FDA for its supplemental new drug application for Sodium Iodide I-131
Capsules USP, Diagnostic-Oral. These
diagnostic Sodium Iodide I-131 capsules are intended to be used by physicians
to perform the radioactive iodide (RAI) uptake test to evaluate thyroid
function prior to treatment with stronger therapeutic doses of Sodium Iodide
I-131. Diagnostic doses of Sodium Iodide
I-131 may also be employed in localizing metastases associated with thyroid
malignancies. We introduced the new
diagnostic capsules in the U.S. market in May 2006.
In November 2006, DRAXIMAGE announced it had been approved by the
FDA to run two clinical trials using radioactive Iobenguane I-131 Injection
(also known as 131I-metaiodobenzylguanidine, or I-131 MIBG) to treat high-risk
neuroblastoma, a rare form of cancer that affects mostly infants and young
children. See Products under
Development.
DRAXIMAGE has a strong regulatory track record. This includes 1 successful audit of our
facilities in 2007 (1 regulatory inspection and 0 client audit) and 2
successful audits of our facilities in 2006 (1 regulatory inspection and 1
client audit).
Sales and Marketing
At the present time, DRAXIMAGEs products are marketed primarily in the
U.S. and Canada. As many of the products
marketed by DRAXIMAGE have the potential for global approvals, it is expected
that non-North American based revenues will increase in the future. The most active growth areas are expected to
be U.S. and Europe. In January 2003,
DRAXIMAGE entered into a marketing and distribution agreement with
Netherlands-based IDB Holland B.V. for the Benelux countries.
United
States
DRAXIMAGE sells Tc-99m kits in the U.S. to several customers and
distributors including Cardinal Health 414, LLC, which operates the largest
chain of radiopharmacies, Covidien (formerly Tyco Healthcare), GE Healthcare,
United Pharmacy Partners Inc. and large university hospitals.
42
Tc-99m kits sold in the U.S. are marketed under the DRAXIMAGE trademark.
On February 2, 2007, DRAXIMAGE announced
it had submitted an ANDA to
the FDA for its generic kit for the preparation of Tc-99m Sestamibi for
injection (DRAXIMAGE
Ò
Sestamibi
), a nuclear medicine imaging
agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to
the heart in patients undergoing cardiac tests.
On July 7, 2007, the Company was informed by the FDA that its ANDA
submission was acceptable for filing.
According to BIO-TECH SYSTEMS, in 2007 there were 8.3 million nuclear
cardiology procedures (out of 17.5 million total nuclear procedures) in the
U.S.A. Sales of nuclear cardiology
products were $1,291.6 million in 2007 (67.0% of total diagnostic radiopharmaceutical
sales). Sales of Cardiolite, the largest
single revenue producer, were $360.7 million (55% of cardiology perfusion
sales) followed by Myoview
Ô
with sales of $202.3 million
(31% of cadiology perfusion sales).
The Sestamibi kit is used in nuclear medicine imaging to show how well
the heart muscle (myocardium) is supplied with blood (perfused) both at rest
and during strenuous activity. The
radioisotope Technetium Tc-99m is attached to the sestamibi molecule forming
Tc-99m Sestamibi. When injected into the
bloodstream this radiopharmaceutical agent is distributed throughout the heart
muscle in proportion to the blood flow received by various portions of the
heart. Heart images are then obtained
using a gamma camera that can detect the Technetium Tc-99m. Two sets of images are typically taken, one
while the patient is at rest and a second set while the patient is under
stress, often by exercising on a treadmill or stationary bicycle. The resulting two sets of images are compared
with each other to diagnose the presence of coronary heart disease by detecting
areas of the heart that may not be receiving normal blood flow. This imaging technique is known as cardiac
stress testing or myocardial perfusion imaging (MPI).
Once its product is approved, DRAXIMAGE plans to enter the MPI market
after the key patent for the currently marketed Tc-99m Sestamibi product
expires, which is expected to be in 2008 for the United States, 2009 for Canada
and from 2007 onwards in various European countries, and after it receives
regulatory approval for the sale of DRAXIMAGE
Ò
Sestamibi.
See Risk Factors Risks Related to our Industry If the Market Does
Not Accept our Products Currently in Development, our Business Could Be
Harmed.
Canada
From January 1, 2003 to December 31, 2007, DRAXIMAGE marketed,
in Canada, most of its products directly to end-users through a co-operative
agreement with Bristol-Myers Canada, pursuant to which Bristol-Myers Canadas
sales force promoted the non-competitive product lines of each party. This distribution agreement terminated on December 31,
2007 and has not been renewed. As of January 1,
2008, DRAXIMAGE is marketing its products in Canada directly to hospitals and
radiopharmacies and through non-exclusive distributors.
For many years, DRAXIMAGE has been the primary Canadian supplier of
Iodine-131 and Iodine-125 labeled radiopharmaceuticals, including solutions and
capsules used primarily for the diagnosis and treatment of thyroid gland
disorders.
The
Company also filed an Abbreviated New Drug Submission (A/NDS) for DRAXIMAGE
Ò
Sestamibi on August 17, 2007 with
Health Canada. On October 11, 2007,
the Company was informed by Health Canada that this submission had been
screened and found acceptable for review.
43
Europe
The radiopharmaceutical market in Europe is characterized by strong
regional fragmentation, which gives the leading market share to the individual
manufacturer located in each of the major countries (e.g. GE Amersham Health in
the UK, Covidien (formerly Tyco Healthcare) in Holland and CIS Bio in
France). DRAXIMAGEs marketing
activities in Europe are at their earliest stages pending regulatory approvals
in this jurisdiction.
As of December 31, 2007, DRAXIMAGE had six regulatory submissions
filed with European regulatory authorities: four with the Medicines Evaluation
Board in the Netherlands, one with the Danish Medicines Agency, and one in
Denmark under the decentralized procedure.
The submission dates for the radiopharmaceutical products filed in the
Netherlands and with the Danish Medicine Agency range from June 2003 to December 2004.
The regulatory submission for our product in Denmark was filed in 2007. All of
the approvals, except for the most recent submission, sought by DRAXIMAGE in
Europe are for marketing authorizations through the mutual recognition
procedure, which involves obtaining approval in one state (the reference
member state) and recognition of that approval in other member states. Five of the approvals being sought by
DRAXIMAGE in Europe are for radiopharmaceutical products already approved in
Canada or the U.S. The most recent submission is for DRAXIMAGE
Ò
Sestamibi which has not yet received approval in Canada or the U.S. Two
of these six European submissions, made for DRAXIMAGE MAA kit and MDP kit,
received approval in a reference member state, the Netherlands, in February 2005
and March 2006. The MDP kit also
received approval in the United Kingdom in February 2008. The MAA kit has also been approved in
Germany, the United Kingdom, Austria and Luxembourg. A third approval for DRAXIMAGEs Sodium
Iodode I-131 capsules was granted in reference member state, Denmark, in September 2007.
DRAXIMAGE has concluded one distribution agreement in respect of the
Benelux countries, with Netherlands-based IDB Holland B.V. DRAXIMAGE is seeking to expand its
distribution network in Europe through strategic alliances with commercial
partners and is currently in discussions with potential partners.
On July 25,
2007, DRAXIMAGE announced it had filed DRAXIMAGE
Ò
Sestamibi with European regulatory
authorities.
Research and Development
DRAXIMAGE conducts both basic research on its own products and
development work on in-licensed products and technology developed by other
firms, predominantly in the biotechnology field. DRAXIMAGE applies its chelating expertise and
technologies to link these compounds with radioisotopes to create innovative
diagnostic and therapeutic radiopharmaceuticals.
In October 2003, DRAXIMAGE received a U.S. patent for a new family
of chelating compounds that have significant potential for the development of
imaging and radiotherapeutic agents to diagnose and treat diseases, including
cancerous tumors or metastases. We
believe that the new family
of chelating compounds may permit the discovery of
diagnostic imaging agents to visualize important biological receptors or
receptor-positive tumors when combined with gamma-emitting radioisotopes. We believe that the compounds are also potentially
useful as therapeutic radiopharmaceuticals for the in-vivo treatment of tumors
and metastases.
DRAXIMAGE is also able to provide labeling technology for other
companies for use with monoclonal antibodies and peptides. We are also working on the development of
novel therapeutic uses of radioactivity.
44
On August 22, 2007 DRAXIMAGE announced
that it had established a research collaboration agreement with Med Discovery
SA of Switzerland to explore the combination of Med Discoverys targeted
protein therapeutics with DRAXIMAGEs radiopharmaceutical expertise in the
therapeutic and diagnostics field.
Med Discoverys lead proteins are themselves
potential therapeutic agents for prostate cancer and a variety of other
cancers. This collaboration provides
initially for the radiolabelling of certain Med Discoverys proteins by
DRAXIMAGE to assess the enhancement of their therapeutic action and their
capability to detect micro tumors. The
proteins will be produced at Med Discoverys facility in Switzerland and
radiolabelled by DRAXIMAGE in Canada.
DRAXIMAGE personnel have extensive experience developing and optimizing
formulations applicable to the lyophilization manufacturing processes used in
the production of cold Tc-99m kit products.
Employees
As at December 31, 2007, DRAXIMAGE had 94
employees
(representing approximately 20% of the Companys employees), consisting of 9
general management and administration employees, 9 marketing, selling and
customer service employees, 24 quality operations employees, 39 manufacturing
employees, and 13 research and development employees. None of these employees is unionized.
Patents
Most of DRAXIMAGEs development products as well as currently sold
products such as SMART-FILL
Ô
are covered by patents held
(or for which patents have been applied) by DRAXIMAGE or licensed from third
parties. DRAXIMAGE has numerous patents
issued and allowed and patent applications pending in the United States,
Canada, Europe and Japan. For example,
DRAXIMAGE has various U.S. issued patents related to chelates for
radiopharmaceutical applications and process patents for the preparation of
certain radiopharmaceuticals. The
patents held by DRAXIMAGE have expiry dates ranging from November 2008 to December 2020. See Risk Factors Risks Related to our
Industry We May not be Able to Obtain and Enforce Effective Patents to
Protect our Proprietary Rights From Use by Competitors, and the Patents of
Other Parties Could Require Us to Stop Using or to Acquire a License for
Conducting Certain Business Activities, and our Competitive Position and
Profitability Could Suffer as a Result.
DRAXIMAGE also relies on trade secrets, know-how and other proprietary
information to protect its current products and technologies. To protect DRAXIMAGEs rights in these areas,
it requires all licensors, licensees, customers and significant employees to
enter into confidentiality agreements.
There can be no assurance, however, that these agreements will provide
meaningful protection to DRAXIMAGEs patents, trade secrets, know-how or other
proprietary information in the event of any unauthorized use or disclosure of
such patents, trade secrets, know-how or other proprietary information. See Risk Factors Risks Related to our
Company If our Collaborative and Commercial Relationships with Third Parties
on Whom we Rely are Unsuccessful, our Business May Suffer.
Other
Collaboration Agreements
We have continuing financial interests associated with our collaboration
agreements with Pfizer with respect to
ANIPRYL
®
and with Shire
with regard to Canadian sales of products divested in 2003. As of January 31, 2005 all deferred
revenue related to the SpectroPharm
Ò
line of products from GSK was
fully amortized by the Company.
45
ANIPRYL
®
Beginning in 1990, we expanded on our knowledge and experience with
selegiline by initiating directly on our own behalf, as well as through
contract research arrangements, studies designed to investigate the potential
of selegiline for companion animal use.
This initiative ultimately resulted in the formation of our subsidiary
DAHI, through which the Company developed and commercialized a companion animal
health product,
ANIPRYL
®
.
ANIPRYL
®
is a selegiline product developed for use in
veterinary prescriptive applications, particularly in dogs. The two indications for which
ANIPRYL
®
is currently approved are canine Cushings disease
and canine cognitive dysfunction syndrome (CDS).
Cushings disease refers to increased blood cortisol and the presence of
one or more typical clinical signs, such as change in appetite, obesity,
frequent urination, abdominal distension, loss of hair, lethargy and other
behavioral changes. Canine Cushings
disease is the form of the disorder that is due to primary hyperfunction of the
pituitary gland.
CDS, sometimes known as Old Dog Syndrome, refers to the onset in
elderly dogs of behavioral problems unrelated to a generalized medical
condition such as neoplasia, infection or organ failure. Typical signs of this disorder can include
confusion, disorientation, decreased activity, changes in sleep/wake cycles,
loss of house training and loss of interest in or ability to interact with its
owner and environment.
From March 1991 to November 1996, DAHIs common shares were
publicly traded on NASDAQ. In November 1996,
the Company took DAHI private in a mandatory share exchange transaction.
In December 1997, we entered into an alliance with Pfizer whereby
Pfizer was granted a perpetual exclusive license to market, sell and distribute
ANIPRYL
®
in exchange for
non-refundable fees, royalties based on the worldwide sales of
ANIPRYL
®
, a manufacturing and supply agreement and a
research collaboration.
In December 1999, the Company and Pfizer amended the terms of the
alliance (the First Amendment) whereby $9.0 million of potential additional
non-refundable fees were eliminated in exchange for the Company receiving
additional regulatory support for a potential new indication and additional
manufacturing data. These potential
additional non-refundable fees would have become payable if Pfizer had
exercised its rights to acquire product registrations following regulatory
approval of
ANIPRYL
®
in designated European countries.
In April 2001, we received a payment of $1.5 million with respect
to minimum royalty entitlements for the first three-year period ended December 31,
2000.
In December 2001, the Company and Pfizer further amended the term
of the alliance (the Second Amendment) whereby the Company received a payment
of $3.1 million with respect to minimum royalty entitlements for the second and
third three-year periods ended December 31, 2001 and 2002 and
modifications to future royalty entitlements.
The Second Amendment also resulted in all rights to
ANIPRYL
®
outside of North America
reverting back to the Company, forfeiture of any additional minimum royalty
entitlements and the termination of any future collaborative research on new
indications or formulations for
ANIPRYL
®
.
46
Cumulatively to December 31, 2007, we received a total of $28.1
million in non-refundable fees and $18.3
million in royalties and royalty-related payments relating
to
ANIPRYL
Ò
.
Under the amended arrangement, we will not be entitled to receive any
additional non-refundable fees but will continue to earn royalties on Pfizers
sales of
ANIPRYL
®
in the United States and
Canada. The $28.1 million of
non-refundable fees already received from Pfizer have been deferred and were
recognized as revenue on a straight-line basis over the period to December 31,
2006 in conformity with Staff Accounting Bulletin No. 101 published by the
U.S. Securities and Exchange Commission.
The amortization of these deferred revenues terminated on December 31,
2006.
We currently do not intend to pursue any additional or expanded
indications for
ANIPRYL
®
.
ANIPRYL
®
is currently approved for
sale in Canada, the United States, Australia, United Kingdom, New Zealand and
Brazil. However,
ANIPRYL
®
is not currently sold in
Australia, New Zealand, the United Kingdom or Brazil.
In 1997, DAHI filed for regulatory approval of
ANIPRYL
®
in Europe by using the
decentralized procedure. This procedure
allows DAHI to file the
ANIPRYL
®
submission in a country of
its choice, and to designate five additional member states of the European
Union as the countries that will review and approve the regulatory
submissions. DAHI chose the United
Kingdom as the country in which to file the initial
ANIPRYL
®
applications. In July 2003, DAHI received
authorization from the Veterinary Medicines Directorale (VMD) to market
ANIPRYL
®
tablets for dogs in the United Kingdom. The United Kingdom submission has been
reformatted in order to be suitable for submission to other European Union
member states. The VMD has acted as
DAHIs advocate in this procedure.
Sales and Marketing
Under the terms of the amended arrangement, Pfizer will continue to
market and sell
ANIPRYL
®
in the United States and
Canada.
In July 2003 DRAXIS granted Ceva Santé Animale S.A. (CEVA) an
exclusive license for the marketing and distribution of
ANIPRYL
®
in Europe. On March 25, 2008, CEVA
and DRAXIS mutually terminated the licence agreement between them effective December 31,
2007. The Company will not seek to
continue to have
ANIPRYL
® approved in Europe.
Manufacturing
DAHIs primary supplier of selegiline for the production of
ANIPRYL
®
is Chinoin Pharmaceutical and Chemical Works
Co. Ltd (Chinoin). In 1995, DAHI
developed the data required to qualify an alternative source of supply for
selegiline, and the BVA and the FDA have accepted the data.
Under its supply agreement with Pfizer, DAHI is entitled to designate a
third-party supplier or to manufacture
ANIPRYL
®
itself in a qualified
facility.
During 2000, Pfizer qualified one of its own facilities to manufacture
ANIPRYL
®
for the North American marketplace. During 2000 and up to the second quarter of
2005, Pfizer manufactured
ANIPRYL
®
.
Since the second quarter of 2005, DRAXIS Pharma manufactures
ANIPRYL
®
at its manufacturing facilities in Kirkland,
Québec.
47
Competition
The animal health marketplace is generally served by veterinary,
agricultural or animal health divisions of large international pharmaceutical
and chemical companies that are involved in research and development
activities. Products resulting from
their activities may, in the future, compete directly with
ANIPRYL
®
.
We are not aware of any other HPFBI, BVA or FDA approved product
available at this time that competes directly with
ANIPRYL
®
. In the United States, the 1988
Generic Animal Drug and Patent Term Restoration Act
offers marketing protection from veterinary generic applicants in the United
States for a period of five years. This
period ended in 2002, in the case of
ANIPRYL
®
. However, that law does not prevent other
companies from repeating the full clinical New Drug Application process to seek
FDA approval for a bio-equivalent product, nor does it prohibit human generic
versions of
ANIPRYL
®
from being sold to
veterinarians. Any such competitor,
including sellers of a human or veterinary generic selegiline, would be subject
to DAHIs U.S. and international patent rights.
No significant competition for
ANIPRYL
®
has been experienced to date
in Canada or the United States from products approved for veterinary or human
use. However, there are two other
treatments available that have not been approved in Canada or the United States
to treat canine Cushings disease, that we believe may be being used off-label
for canine Cushings disease:
LYSODREN
®
(mitotane) by
Bristol-Myers Squibb Co., which was approved for use in the treatment of human
inoperable cancer of the adrenal gland and
NIZORAL
®
(ketoconazote)
tablets by Johnson & Johnson, Inc., an anti-fungal medication,
which was approved for the treatment of various internal and external fungal
and yeast infection in humans. These
competitive treatments work by selectively killing the outer layer of the
adrenal gland, thereby limiting production of corticosteroid. The human generic version of
ELDEPRYL
®
is not approved for the treatment of canine
Cushings disease or CDS in Canada, the United States or elsewhere. However, we believe that such use of human
selegiline may compete with the use of
ANIPRYL
®
in dogs. The dosage required for dogs suffering from
canine Cushings disease and CDS, in most cases, is much higher than the human
5mg dose for selegiline.
Patents for the use of
ANIPRYL
®
for the treatment of dogs
with conditions including canine Cushings disease and CDS are issued in
Canada, the United States and other jurisdictions. We believe DAHI is positioned to enforce its
proprietary patent rights and defend itself against infringement by other parties.
48
Patents
In September 1992, the United States Patent and
Trademark Office issued a patent to DAHI entitled Use of l-deprenyl for
Retention of Specific Physiological Function.
The patent claims specific uses of l-deprenyl for use in treating dogs
and covers currently sold products.
Similar patents have also issued to DAHI in many foreign
jurisdictions, including Canada, New Zealand, Venezuela and Europe. Six additional U.S. patents have also issued
to DAHI. These patents cover various veterinary pharmaceutical uses of
l-deprenyl such as treatment of Cushings Disease, weight loss, treatment of
immune system dysfunction, extension of life expectancy of dogs, and treatment
of hearing loss. Four of these six
patents were also filed in foreign countries that have major companion animal
markets. The markets for the cognitive
disease patents are Canada, U.S., Europe, Japan, Mexico, Venezuela, New Zealand
and Malaysia. The markets for the
Cushings Disease patent are Europe, Canada and the U.S. The markets for the survival cure shifting
patent are Canada, Norway, Finland and Europe.
The markets for the treatment of hearing loss patent are Japan and
Canada. The patents held by DAHI have
expiry dates ranging from August 31, 2010 to June 3, 2016.
The European CDS patent was subject to an opposition procedure initiated
by CEVA. CEVA holds patents in the
United States, Canada and Europe relating to the use of selegiline for treating
behavioral disorders with change of mood in dogs and cats. CEVAs European patent was subject to an
opposition procedure by DAHI. In July 2003,
DRAXIS and CEVA agreed to discontinue the opposition proceedings between them
before the EPO. DRAXIS also granted CEVA
an exclusive license for the marketing and distribution of
ANIPRYL
®
or the use of
ANIPRYL
®
claims in Europe. In return, CEVA agreed to pay DAHI a
percentage royalty on European sales of
ANIPRYL
®
and/or the use of
ANIPRYL
®
claims, in addition to nominal milestone
payments upon the regulatory approval of
ANIPRYL
®
in the UK and in subsequent
additional jurisdictions within the European Community. The agreement also gave DAHI the rights to
use Chinoin selegiline in any jurisdiction.
On March 25, 2008, CEVA and DRAXIS mutually terminated the licence
agreement between them effective December 31, 2007. The Company will not seek to continue to have
ANIPRYL
® approved in Europe.
SpectroPharm® Product Line
In May 2000, we entered into an arrangement with Block Drug Company
(Canada) Limited, now part of GlaxoSmithKline Consumer Healthcare, with respect
to the SpectroPharm
®
line of non-prescription dermatology products,
which included the sale of product rights by the Company in exchange for a
non-refundable fee, the acquisition of inventory on hand, a supply agreement
and a technical services arrangement.
The $9
million we received with respect
to the SpectroPharm
®
product rights was deferred and was recognized
as revenue on a straight-line basis over the period to January 31,
2005. As of January 31, 2005, all
deferred revenue related to the SpectroPharm
Ò
line of products
was fully amortized.
Discontinued
Operations (DRAXIS Pharmaceutica)
In July 2003, we completed the divestiture
of our Canadian pharmaceutical sales and marketing division, DRAXIS
Pharmaceutica, with the sale to Shire of substantially all remaining products
of the division, including the Canadian product rights for Alertec
®
,
Diastat
®
, Hectorol
®
, Permax
®
and Zanaflex
®
. Shire
agreed to pay DRAXIS through a combination of cash and contingent milestone
payments plus royalties on future product sales. In addition, Shire assumed responsibility for
the financial provisions of the license agreement related to Permax
®
.
49
Government Regulation
Our business is governed by a variety of industry-specific statutes and
regulations in Canada, the United States and other countries.
DRUGS
Drug Approval Process
Human
Pharmaceuticals
In Canada, pharmaceutical research, development and marketing activities
are regulated by the Food and Drugs Act (Canada) and the rules, regulations,
policies and guidelines made thereunder.
Insofar as it relates to drugs for human use, the Food and Drugs Act
(Canada) is administered by the Therapeutic Products Directorate of the Health
Products and Food Branch (TPD), which regulates the use and sale of
diagnostic and therapeutic products in Canada.
In the United States, these activities are regulated under laws
administered by the Food and Drug Administration (FDA), which also have a
significant impact on the Companys activities.
The drug research and development process consists of both pre-clinical
and clinical phases. The pre-clinical
phase consists of screening compounds to identify the most promising leads for
continued drug development prior to human clinical trials and evaluating the
drugs toxicologic and pharmacologic effects to show that the drug is
reasonably safe for use in the initial clinical studies. The clinical phase involves clinical trials
with healthy participants, as well as patients with specific diseases or
conditions.
Before commencing clinical trials in Canada or the United States, a
Clinical Trial Application (CTA) must be submitted with the TPD (in the United
States an Investigational New Drug (IND) application must be submitted with
the FDA). The CTA or IND application
includes manufacturing data, pre-clinical data, information about use of the
drug in humans for other purposes and a detailed protocol for the conduct of
clinical trials.
In Canada and the United States, clinical trials of new pharmaceutical
products involve three phases. In Phase
I, the products safety is assessed during clinical trials involving a limited
number of healthy volunteers or patients.
In Phase II, the products efficacy, dosage and safety are tested on a
small number of patients with a known disease.
In Phase III, controlled clinical trials are conducted in which the
product is administered to a larger number of patients with a known disease,
and further information relating to safety and efficacy is gathered. Further, in Phase III, the effectiveness of
the product is, in certain cases, compared to that of accepted methods of treatment. If clinical studies establish that the
product has value, an applicant files a New Drug Submission with the TPD (or a
New Drug Application, or Product License Application or Biologic License
Application (for biological products) with the FDA) to obtain marketing
approval for the product. The New Drug
Submission/New Drug Application/Product License Application/Biologic License
Application includes a comprehensive summary and analysis of the results of the
clinical trials, information relating to proposed labeling and packaging
materials, and data relating to the proposed manufacturing and quality control
procedures.
If the New Drug Submission/New Drug
Application/Product License Application/Biologic License Application is found
to be satisfactory, a marketing authorization is issued (in Canada, the TPD
issues a Notice of Compliance).
The process of completing clinical trials and obtaining regulatory
approvals for a new drug will, in general, take a number of years and require
the expenditure of substantial resources.
Once a New Drug Application/New Drug Submission or Product License
Application/Biologic License Application is submitted, there can be no
assurance that the TPD or FDA will review and approve the application in a
50
timely manner.
In certain limited circumstances, the TPD will permit a New Drug
Submission to be subject to a priority review.
The TPDs Priority Review Process allows for a faster review to make
available promising drug products for a serious, life-threatening or severely
debilitating illness or condition for which there is substantial evidence of
clinical effectiveness that the drug provides: (i) effective treatment,
prevention or diagnosis of a disease or condition for which no drug is
presently marketed in Canada; or (ii) a significant increase in efficacy
and/or significant decrease in risk such that the overall benefit/risk profile
is improved over existing therapies, preventatives or diagnostic agents for a
disease or condition that is not adequately managed by a drug marketed in
Canada.
Even after initial approval has been obtained, further studies,
including post-marketing studies, may be required to provide additional data on
safety necessary to gain approval for the use of the product as a treatment for
clinical indications other than those for which the product was initially
tested. The TPD and FDA may also require
post-marketing surveillance programs in order to monitor long-term risks and
benefits of the drug, to study different dosages or evaluate different safety
and efficacy parameters. Results of
post-marketing studies may limit or expand the further marketing of
products. A serious safety or
effectiveness problem involving an approved new drug may result in TPD or FDA
action requiring withdrawal of the product from the market and possible civil
action.
The Special Access Program of the TPD provides practitioners with access
to pharmaceutical, biologic and radiopharmaceutical products that are not yet
approved for sale in Canada to treat patients with serious or life-threatening
illness or conditions when conventional therapies have failed, are unsuitable
or unavailable. The FDA administers a
similar program in the United States to treat patients with immediately
life-threatening diseases.
Outside of Canada and the United States, the regulatory approval process
for the manufacture and sale of pharmaceuticals varies from country to country,
and the time required may be longer or shorter than that required for TPD or
FDA approval. To the extent it chooses
to explore foreign markets, the Company may rely on foreign licensees to obtain
regulatory approval for marketing its products in foreign countries.
Veterinary
Pharmaceuticals
In Canada, the drug approval process for veterinary pharmaceuticals is
similar to the process for obtaining approvals for human pharmaceuticals. To receive regulatory approval, a new animal
drug must successfully complete a number of developmental phases which include
the establishment of safety and efficacy in target species, establishment of
manufacturing procedures and the conduct of controlled clinical trials in which
the drug is administered to a large number of animals in order to gather
further information relating to safety and efficacy.
Following the completion of clinical trials, an applicant files a New
Drug Submission to the Veterinary Drugs Directorate.
Drug Marketing
Human
Pharmaceuticals
Prescription drug products generally are made known to healthcare
professionals through advertisements and visits to such professionals, known as
detailing. In Canada, unlike the
United States, product-specific advertising to the general public is generally
not permitted, subjected to very limited exceptions.
51
An increasing percentage of sales of prescription pharmaceuticals
relates to sales of products which are paid for, in whole or in part, by
government or private insurance drug plans.
In many jurisdictions, governments have established regimes to control
drug pricing at the retail pharmacy level.
Most Canadian provinces have implemented drug benefit formularies. A formulary lists the drugs for which a
provincial government will reimburse qualifying persons and the prices at which
those drugs will be reimbursed. Although
there is not uniformity among provinces, generally speaking, provincial
governments will reimburse an amount equal to the lowest available price of the
generic versions of any drug listed on the provincial formulary. The legislative regimes of most provinces
also permit generic drug substitution, even for patients who do not qualify for
government reimbursement. The effect of
these initiatives is to encourage the sale of lower-priced generic versions of
pharmaceutical products. In the United
States, beginning in 2006, Medicare beneficiaries will be offered a
prescription drug benefit. Medicare will
contract with at least two risk-bearing drug plans in each of 34 regions to
provide the new benefit. The
prescription drug plans will cover at least two drugs in each therapeutic class
or category of covered drugs, but may establish formularies and tiered-cost
amounts. The prescription drug plans may
limit their coverage to two drugs in each therapeutic class or category of
covered drugs. The effect of this new
program will allow prescription drug plans to negotiate price discounts and
rebates with drug companies.
Furthermore, there have been, and the Company expects that there will
continue to be, an increasing number of proposals to implement government and
other third-party payer restrictions on the pricing of prescription
pharmaceuticals as a result of continuing efforts to contain or reduce the
costs of healthcare throughout North America.
See Item 3: Key Information -
Risk Factors. Notably, in Canada, the
Patented Medicines Prices Review Board (PMPRB) sets the maximum price that
can be charged for a patented drug (see discussion below on Patent Protection
and Price Controls).
Veterinary
Pharmaceuticals
In Canada, veterinary prescription pharmaceuticals are available only
through veterinarians. Veterinary
prescription drugs are generally promoted by manufacturers through
advertisements to veterinarians and sales visits to animal health clinics. In Canada, unlike the United States, product-specific
advertising to the general public is generally not permitted, subjected to very
limited exceptions.
The PMPRB has the jurisdiction to regulate maximum pricing of veterinary
drugs (see below), but actively exercises that jurisdiction only in response to
complaints it may receive. There are no
government reimbursement plans in the veterinary pharmaceutical
marketplace. There are a few private pet
insurance plans; however, these plans do not cover a significant portion of the
purchase for veterinary drugs.
Accordingly, the veterinary marketplace is not subject to the same cost
containment measures that are prevalent in the human pharmaceutical market.
Patent Protection and Price Controls
Companies that have invented human or veterinary drugs can apply for
patent protection virtually worldwide, subject to strict rules relating to
timing, subject matter and the scope of protection sought. Patents can cover many aspects of a
pharmaceutical product, including the drug itself, processes for preparing the
drug, delivery systems and new uses for the drug. Patents do not, however, guarantee that the
owner of the patent or its licensee can utilize the patented invention because
there may be pre-existing patent rights owned by a third party. While a patent permits the owner or its
licensee to prevent others from doing what is covered by the patent,
competitors are always free to market products that do not infringe the
particular patent, provided such competitors otherwise comply with health
regulatory requirements.
52
Historically, pharmaceutical companies have relied heavily upon patents
to protect proprietary positions in respect of drug products. The Companys policy is to protect its
technology, inventions and improvements by, among other things, filing patent
applications for technology it considers important to the development of its
business. The Company also relies upon
trade secrets, know-how and licensing opportunities to develop and maintain its
competitive position.
Under United States patent law, a patent is issued to the person who
made the invention first, rather than to the first person to file an
application therefor, as is common in other countries, such as Canada. Consequently, in determining who is entitled to
a United States patent for a particular technology,
it
is important to consider that it is possible for an inventor to establish an
entitlement based on a prior invention, notwithstanding an earlier filed patent
application.
Prior invention may not be
established before December 8, 1993, in a NAFTA country other than the
United States, or before January 1, 1996, in a WTO member country other
than a NAFTA country.
Remedies for patent infringement are created under the laws of Canada
and the United States. In addition to
the standard legal action for patent infringement, in 1993, the Canadian
Government enacted Regulations under the Patent Act (Canada) whereby a company
proposing a generic version of a drug which has been marketed in Canada under a
Notice of Compliance and in respect of which patents have been listed on the
Patent Register, must address those patents before a Notice of Compliance may
be granted. The originator of the drug
may apply to the Federal Court of Canada for an order prohibiting the Minister
of National Health and Welfare from issuing a Notice of Compliance until the
issue of possible patent infringement has been resolved or the passage of
twenty-four months from commencement of Federal Court proceedings, whichever
comes first. Similar proceedings are
available in the United States if a generic drug manufacturer seeks approval
for a drug in respect of which patents have been listed in the Orange Book (the
United States equivalent of the Patent Register).
As mentioned above, in Canada, the PMPRB monitors and controls prices of
drug products marketed in Canada by persons holding, or licensed under, one or
more patents relating to those drug products.
The PMPRB approves the introductory price of a drug product (based on a
comparative analysis) and requires that subsequent price increases do not
exceed the annual increase of the Canadian Consumer Price Index. Thus, in Canada, the existence of one or more
patents relating to a drug product, while providing some level of proprietary
protection for the product, also triggers a governmental price control regime
which significantly impacts on the Canadian pharmaceutical industrys ability
to set pricing.
Drug Manufacturing
Pharmaceutical companies are required to submit as part of their New
Drug Submission in Canada, or as part of their New Drug Application in the
United States, detailed descriptions regarding the proposed manufacturing and
packaging process and the identities of the manufacturers in respect of a
particular drug. A decision to
manufacture or package products in a facility other than that originally
approved under the New Drug Application or New Drug Submission (as may be the
case with contract manufacturing outsourcing) requires notification of the
regulatory authorities and can result in significant delays in production.
Pharmaceutical manufacturing facilities are subject to strict quality
control standards including current good manufacturing practices
(cGMPs). Production processes within a
facility are subject to one-time validation testing, as well as periodic
review. In the case of sterile product
manufacturing, including lyophilized products, the standards are even higher
than for the manufacturing of non sterile products. The manufacture of radioactive drugs is
subject not only to cGMPs but also the environmental safety, handling and
transportation requirements of the Canadian Nuclear Safety Commission (CNSC)
53
and the United States Nuclear Regulatory
Commission (NRC). There are no issues
with respect to radioactive waste disposal since all of the isotopes used in
nuclear medicine are short-lived and can be easily stored on site until decayed
and then disposed of.
The FDA, the Health Products and Food Branch of Health Canada (HPFBI),
CNSC and NRC conduct regular audits of the Companys facilities to ensure
compliance with cGMPs and other statutory requirements. See Risk Factors Risks related to our
industry.
ENVIRONMENTAL
LAWS
Canadian
and U.S. federal, state, local and provincial regulations govern extensively
the use, manufacture, storage, handling, transport and disposal of hazardous
materials and associated waste products.
The Company is not aware of any material environmental issues that affect
the Companys utilization of its assets.
As of December 31, 2007, the Company has not received any notice
stating that it is not in compliance with environmental legislation applicable
to it.
54
ORGANIZATIONAL
STRUCTURE
The following chart illustrates the corporate organizational structure
and governing jurisdictions of the Company and its significant affiliates as at
March 31, 2008.
All of
the below-depicted companies are wholly owned subsidiaries of DRAXIS.
(1)DRAXIS
Specialty Pharmaceuticals Inc. has two divisions, DRAXIMAGE
(radiopharmaceuticals) and DRAXIS Pharma (contract manufacturing).
PROPERTY,
PLANTS AND EQUIPMENT
Our sole operating facility is a 247,000-square-foot pharmaceutical
manufacturing facility which houses the DRAXIMAGE and DRAXIS Pharma
operations. The facility is owned by
DRAXIS Specialty Pharmaceuticals Inc., a wholly-owned subsidiary of the Company
and is located at 16751 Trans-Canada Road, Kirkland, Québec, Canada, H9H
4J4. See Risk Factors Risks Related
to our Company We only have one manufacturing facility and factors beyond our
control could cause an interruption in our manufacturing operations, which
could adversely affect our reputation in the market place and our results of
operations.
55
On November 27, 2007, the Company announced that it had initiated
construction of a 77,000 square foot new secondary packaging and warehousing
facility in the Montréal area to aid DRAXIS in fulfilling its obligation under
its recently announced contract to produce a broad portfolio of multiple
non-sterile specialty semi-solid products for JJC. The new facility is expected to be completed
by mid-2008, after which equipment will be installed and validated to ensure
compliance with applicable regulatory requirements.
The new facility has been custom designed by and is being built by
Montréal based developer Broccolini Construction Inc., specifically to meet the
needs of DRAXIS with respect to this major new contract but will be owned by
the Broccolini Group of Companies and leased to DRAXIS under a seven year
agreement with options to renew. The
facility will be situated in the Montréal area in the community of
Ste-Anne-de-Bellevue close to major highway access and within ten kilometers
(six miles) of the main DRAXIS production facility in Kirkland, just outside
Montréal.
As of December 31, 2007, we have no third-party debt outstanding
other than as provided for in Note 16 of the Consolidated Financial Statements.
Item 4A Unresolved Staff Comments
There are no unresolved written comments that were received from the
Securities and Exchange Commissions staff 180 days or more before the end of
the Companys fiscal year to which this Annual Report relates.
Item 5. Operating and Financial Review and Prospects
The following managements discussion and analysis (MD&A) of the
financial condition and results of operations of DRAXIS Health Inc. (DRAXIS
or the Company) is based on the Companys audited consolidated financial
statements and notes thereto for the year ended December 31, 2007 and
should be read in conjunction therewith.
All amounts referred to herein are expressed in U.S. dollars and are in
accordance with U.S. generally accepted accounting principles (GAAP), unless
otherwise indicated. Other noteworthy
accounting issues are discussed under Accounting Matters.
Readers are cautioned not to place undue reliance on forward-looking
statements contained in this MD&A since actual results could differ materially
from what we expect if known or unknown risks affect our business or if an
estimate or assumption turns out to be inaccurate. Unless otherwise required by applicable
securities laws, the Company disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise (see Forward-Looking Statements on page 79
hereof).
This MD&A is dated February 29, 2008.
Overview
DRAXIS
is a specialty pharmaceutical company providing pharmaceutical products in
three major categories: sterile, including sterile lyophilized (freeze-dried)
pharmaceuticals; non-sterile specialty pharmaceuticals; and
radiopharmaceuticals. In the
radiopharmaceutical category, DRAXIS has its own products and a targeted
research and development (R&D) program for new and/or improved products.
56
Termination of Amortization of
Anipryl® Deferred Revenues
As
indicated in prior disclosures, substantially all revenues related to the
amortization of previously received
Anipryl
®
milestones terminated on December 31, 2006. The amortization of these
deferred revenues has previously resulted in non-cash revenues of $0.8 million
per quarter, contributing approximately 7 cents of earnings per share (EPS)
per full year. The termination of this source of non-cash revenue and operating
income has no effect on cash flows but affects year-over-year comparisons of
operating results beginning with the first quarter of 2007 (see Corporate and
Other).
Consolidated Results of Operations
(in thousands of U.S.
dollars, except share related data) (U.S. GAAP)
|
|
2007
|
|
2006
|
|
2005
|
|
Revenues
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
76,072
|
|
$
|
83,545
|
|
$
|
72,989
|
|
Royalty and licensing
|
|
2,668
|
|
2,121
|
|
3,143
|
|
Anipryl
® deferred revenues
|
|
120
|
|
3,301
|
|
3,301
|
|
|
|
$
|
78,860
|
|
$
|
88,967
|
|
$
|
79,433
|
|
|
|
|
|
|
|
|
|
Product gross
margin
|
|
$
|
26,454
|
|
$
|
36,462
|
|
$
|
26,153
|
|
% of Product sales revenues
|
|
34.8
|
%
|
43.6
|
%
|
35.8
|
%
|
Royalty and
licensing revenue
|
|
2,788
|
|
5,422
|
|
6,444
|
|
SG&A
|
|
(18,807
|
)
|
(19,425
|
)
|
(16,185
|
)
|
% of Product sales revenues
|
|
-24.7
|
%
|
-23.3
|
%
|
-22.2
|
%
|
R&D
|
|
(2,446
|
)
|
(2,372
|
)
|
(2,103
|
)
|
Depreciation and
amortization
|
|
(5,841
|
)
|
(5,135
|
)
|
(4,545
|
)
|
Operating income
|
|
2,148
|
|
14,952
|
|
9,764
|
|
% of Total revenues
|
|
2.7
|
%
|
16.8
|
%
|
12.3
|
%
|
Financial
|
|
|
|
|
|
|
|
- Foreign
exchange (loss) gain
|
|
(1,716
|
)
|
282
|
|
(398
|
)
|
- Other
|
|
870
|
|
347
|
|
(29
|
)
|
Income tax
(recovery) expense
|
|
(356
|
)
|
4,034
|
|
1,553
|
|
Net
income
|
|
$
|
1,658
|
|
$
|
11,547
|
|
$
|
7,784
|
|
|
|
|
|
|
|
|
|
Basic earnings
per share
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.19
|
|
|
|
|
|
|
|
|
|
Diluted earnings
per share
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.18
|
|
The following provides a high-level overview of the
consolidated results of the Company.
Please see Segment Reporting for more detailed explanations.
Comparison of Years Ended December 31,
2007 and 2006
Consolidated
revenues for the year ended December 31, 2007 decreased 11% compared to
the year ended December 31, 2006 due to lower volumes in contract
manufacturing and the loss of the non-cash
Anipryl
®
deferred revenue amortization. These factors were partially offset by one-time
contingent milestone payments from Shire BioChem Inc. (Shire) which were
earned in the first quarter of 2007.
57
Consolidated
product sales decreased 9% to $76.1 million for 2007 compared with the same
period in 2006. Contract manufacturing
product sales decreased 15% in 2007 compared to the same period of 2006. The
decrease was related to lower sterile volumes mainly due to lower demand for
Hectorol
®
and lower sterile
volumes under the GSK contract relative to 2006. Radiopharmaceutical product
sales increased 8% over the same period of 2006. The increase was due to the
inclusion of a chargeback for freight services beginning on April 1,
2007. In addition, the Company suspended
production of a private label radioactive product for one customer that
historically contributed $350,000 in quarterly product sales.
During
the course of 2007, two separate shortages for the supply of radioactive
isotopes occurred which impacted the financial performance of the
radiopharmaceutical segment. The first shortage resulted in the Company
obtaining the approval of a secondary source of supply for the U.S. market. The
second shortage created an industry-wide decrease in demand in late 2007 for
radioactive procedures due to a short supply in the marketplace of
radioisotopes, being the key ingredient.
Product
gross margin percentages for 2007 decreased to 35% as compared with 44% for the
same period in 2006. The decline is attributable to reduced margins in the
contract manufacturing segment resulting from lower sterile volumes,
principally volumes of
Hectorol
®
.
The
increase in royalty and licensing revenue for the year ended December 31,
2007 compared to 2006 reflects the receipt of $0.8 million of contingent
milestone payments from Shire in the first quarter of 2007.
As a
percentage of product sales, selling, general and administrative (SG&A)
expenses were 25% for 2007 compared to 23% for 2006. SG&A expenses decreased for 2007 compared
to 2006 due to an overall decrease in incentive plan accruals which more than
offset total severance costs of $2.3 million during 2007.
Overall
R&D expenditures were similar for 2007 compared to 2006. R&D resources in 2007 were largely
focused on the DRAXIMAGE
®
Sestamibi and MOLY-FILL Technetium
Generator projects.
Depreciation
and amortization expense for all of 2007 increased compared to 2006 due to the
completion of the Companys IT and SAP upgrade activities in 2007, including
the implementation of a new warehouse management system.
The
majority of the Companys operating costs are denominated in Canadian dollars.
As the level of revenues denominated in U.S. dollars and other foreign currencies
increases relative to the underlying cost structure, the Companys overall
gross profit margins and SG&A expenses are negatively affected during
periods where the Canadian dollar appreciates in value.
Foreign
exchange had a significant impact in 2007 compared with 2006 due to the
continued rapid strengthening of the Canadian dollar beginning in April 2007,
which resulted in a foreign exchange loss of $1.7 million for 2007. The Company
is subject to a foreign exchange loss as a result of the negative impact of the
strengthening of the Canadian dollar on U.S. dollar-denominated monetary assets
held by the Company. The Company expects to partially mitigate its currency
related risk over the next 12 to 15 months by an increase in its U.S.
dollar-denominated customer financing related to activities expected to be
carried out in connection with the new non-sterile manufacturing contract with
JJC.
The
effective tax rate is lower than the statutory rate due primarily to the amount
of R&D tax credits earned in the year. The Companys effective tax rate
will vary from the statutory tax rate
58
depending on the mix of net income combined with the
statutory rates in the respective jurisdictions in which the Company operates.
The
basic weighted-average number of common shares outstanding during 2007 was
41,955,989 and has increased from 41,592,507 in 2006, primarily as the result
of the exercise of stock options, offset by shares purchased for cancellation
under the Companys Normal Course Issuer Bid initiated in December 2006. As at the date hereof, the Company has
42,062,538 common shares outstanding and also has outstanding 2,135,828 options
to acquire common shares.
Comparison of Years Ended December 31,
2006 and 2005
The
financial results for the year ended December 31, 2005 were negatively
affected by the extended shutdown period that occurred in the sterile products
area of the Companys contract manufacturing business. Accordingly, all comparative variances on a
consolidated basis and in the contract manufacturing section reflect the impact
of the extended shutdown in 2005.
Consolidated
revenues for the year ended December 31, 2006 are 12% higher compared to
2005.
Consolidated
product sales have grown by $11 million, or 15%, for the year ended December 31,
2006 compared to 2005, driven by lyophilization revenue (sterile products) in
contract manufacturing and Sodium Iodide I-131 sales in the radiopharmaceutical
business (see the Contract
Manufacturing segment discussion below).
Radiopharmaceutical
product sales grew 12% driven by radioiodine sales in the U.S. including
diagnostic capsules, which were introduced in the U.S. marketplace in the
second quarter of 2006.
Consolidated
product gross margin percentages for the year ended December 31, 2006
increased to 44% as compared with 36% for 2005. The increase reflects a better
mix of higher margin business in both operating segments, especially sterile
product volume in contract manufacturing.
Royalty
and licensing revenue decreased for the year ended December 31, 2006
compared with 2005. The decrease in royalty and licensing revenue for the year
ended December 31, 2006 compared to 2005 reflects the receipt of a $0.9
million contingent milestone payment from Shire in 2005.
As a
percentage of product sales, SG&A expenses were 23% for the year ended December 31,
2006 compared to 22% for 2005. The 20% increase in SG&A expenses in
absolute dollar terms (excluding the impact of foreign currency translation) for
the year ended December 31, 2006 as compared with 2005 was driven by the
inclusion of non-cash stock-based compensation costs beginning January 1,
2006, coupled with increased incentive plan accruals based on the Companys
financial performance for 2006 relative to 2005. The impact of the strengthening of the
Canadian dollar for much of 2006 relative to 2005 increased the nominal value
of SG&A expenses.
R&D
expenditures increased slightly for the year ended December 31, 2006
compared to 2005 due to the work related to specific phases of the Companys
development activities related to DRAXIMAGE
®
Sestamibi and the
MOLY-FILL
Ô
Technetium Generators as the
Company completed stages of activities with respect to both initiatives late in
2006. These products are described in the Radiopharmaceuticals section.
Depreciation
and amortization expense for the year ended December 31, 2006 increased by
13% over 2005 following the commencement of depreciation charges on the
Companys contract manufacturing capital upgrades.
59
The
majority of the costs of the Canadian operations are denominated in Canadian
dollars. As the level of revenues denominated in U.S. dollars and other foreign
currencies increases relative to the underlying cost structure, the Companys
overall gross profit margins and SG&A expenses are affected. The impact is
not material on the overall financial performance for the year.
The net
foreign exchange gain for the year ended December 31, 2006 was $282,000
compared to a loss of $398,000 for 2005. As a result of the impact of the
weakening of the Canadian dollar late in 2006, a foreign exchange gain was
earned on U.S. dollar-denominated monetary items in 2006, whereas the
strengthening of the Canadian dollar late in 2005 created a foreign exchange
loss.
Net
financial income for 2006 was $347,000 compared to an expense of $29,000 in
2005 due to significant interest income generated from surplus cash.
For the
year ended December 31, 2006, the Company recorded an income tax expense,
expressed as a percentage of pre-tax earnings of 26%. The Companys effective tax rate will vary
from the statutory tax rate depending on the mix of income combined with the
statutory rates in the respective jurisdictions in which the Company operates.
The level of tax credits generated from R&D activities in the
radiopharmaceutical business also has the impact of lowering effective tax
rates.
The
effective tax rate for 2006 was higher than in 2005 due to a one-time
adjustment to revalue the Companys income tax assets to a lower rate following
the enactment of a statutory rate change to Canadian federal taxes in the
second quarter of 2006.
The
basic weighted-average number of common shares outstanding during 2006 was
41,592,507 and increased from 41,471,798 for 2005, primarily as a result of the
exercise of stock options offset by the shares purchased for cancellation under
the Companys Normal Course Issuer Bid.
Radiopharmaceuticals
(in
thousands of U.S. dollars) (U.S. GAAP)
|
|
2007
|
|
2006
|
|
2005
|
|
Revenues
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
23,216
|
|
$
|
21,508
|
|
$
|
19,290
|
|
Royalty and licensing
|
|
|
|
(3
|
)
|
9
|
|
|
|
$
|
23,216
|
|
$
|
21,505
|
|
$
|
19,299
|
|
|
|
|
|
|
|
|
|
Product gross margin
|
|
$
|
12,976
|
|
$
|
13,433
|
|
$
|
11,593
|
|
% of Product sales revenues
|
|
55.9
|
%
|
62.5
|
%
|
60.1
|
%
|
SG&A
|
|
(5,382
|
)
|
(4,380
|
)
|
(4,660
|
)
|
R&D
|
|
(2,446
|
)
|
(2,372
|
)
|
(2,103
|
)
|
Depreciation and amortization
|
|
(1,096
|
)
|
(1,110
|
)
|
(1,047
|
)
|
Operating income
|
|
$
|
4,052
|
|
$
|
5,568
|
|
$
|
3,792
|
|
% of Revenues
|
|
17.5
|
%
|
25.9
|
%
|
19.6
|
%
|
Nuclear
medicine imaging and therapeutic agents are the focus of the Companys
radiopharmaceutical division, DRAXIMAGE, which develops, manufactures and
markets diagnostic imaging and therapeutic radiopharmaceutical products for the
global marketplace. Products currently marketed by DRAXIMAGE include a line of
lyophilized Technetium-99m kits used in nuclear medicine imaging procedures and
a line of imaging and therapeutic products labelled with a variety of isotopes
60
including Sodium Iodide I-131. DRAXIMAGE has a number
of products in late-stage development including a generic Sestamibi injection,
a lyophilized product that is widely used for Technetium-based cardiac imaging
studies and MOLY-FILL, a next-generation version of a Technetium Generator.
Comparison of Years
Ended December 31, 2007 and 2006
Revenues
for 2007 increased 8% compared to 2006 driven by the inclusion of freight
charges in revenues effective April 1, 2007.
Product
revenues decreased excluding the inclusion of freight charges compared to 2006.
The decrease is due to the Company temporarily suspending production early in
the third quarter of 2007 of a private label radioactive product for one
customer. This product contributed historically $350,000 to quarterly revenues.
It is the Companys belief that the customer will either permanently withdraw
this product from the marketplace or make formulation changes and their
decision is expected in the first half of 2008.
The
radiopharmaceutical segments revenues were also impacted by lower demand
related to an industry shortage of radioactive medical isotopes in the fourth
quarter of 2007. This was related to an extended shutdown at one of the largest
global suppliers of radioactive isotopes late in 2007. While the Company has an
alternative approved source of supply for its raw materials, the shutdown
affects the ability of radiopharmacies to carry out procedures resulting in
lower demand. The Company was also impacted by a similar shutdown in the second
quarter of 2007, which resulted in the Company seeking and obtaining regulatory
approval for an alternative source of supply.
In
2007, the Company began installing its new capsule-filler technology (DRAXIMAGE
SMART-FILL) at customer radiopharmacies. The Companys introduction of its
DRAXIMAGE SMART-FILL capsule-filler technology is expected to drive further
growth into 2008. Installation of these units will continue into 2008.
Product
gross margin for 2007 decreased to 56% compared to 63% for 2006 due to
inclusion of freight charges in both revenues and cost of goods sold beginning
on April 1, 2007 and foreign exchange pressures related to the dramatic
strengthening of the Canadian dollar over 2006.
SG&A
expenses increased $1.0 million for 2007 relative to the same periods of 2006
due to an increased investment in business development activities coupled with
regulatory filing fees for Europe and Canada.
Overall
R&D expenditures were similar for 2007 compared to 2006. R&D resources in 2007 were largely
focused on the DRAXIMAGE
®
Sestamibi and MOLY-FILL
Ô
Technetium Generator projects.
Operating
income was $1.5 million lower for all of 2007 compared to the same period of
2006 due to decreased sales volumes as described above, pressures on margin
from a stronger Canadian dollar, regulatory filing fees and increased business
development activities.
Depreciation
and amortization expense for this segment was relatively unchanged for 2007
compared to the same period of 2006.
61
Radiopharmaceutical
Product Development Strategy
DRAXIMAGE
®
Sestamibi
As
announced on February 2, 2007, DRAXIMAGE submitted an Abbreviated New Drug
Approval (ANDA) to the U.S. Food and Drug Administration (FDA) for its
generic kit for the preparation of Tc-99m Sestamibi for injection, DRAXIMAGE
®
Sestamibi, a nuclear medicine imaging agent used in myocardial perfusion
imaging (MPI) to evaluate blood flow to the heart in patients undergoing
cardiac tests. Furthermore, the FDA acknowledged in July 2007 the receipt
and acceptance for review of the ANDA for DRAXIMAGE
®
Sestamibi that
was submitted.
The
Company also announced on July 25, 2007 the filing of DRAXIMAGE
®
Sestamibi with European regulatory authorities.
The filing marks another milestone in the comprehensive plan to pursue
major MPI markets globally.
The
Company also filed an Abbreviated New Drug Submission (A/NDS) for DRAXIMAGE
®
Sestamibi on August 17, 2007 with Health Canada. On October 11, 2007, the Company was
informed by Health Canada that this submission had been screened and found
acceptable for review.
The
filing of the ANDA with the FDA, the A/NDS and the submission to the European
regulatory authorities represented the achievement of key milestones in the
DRAXIMAGE
®
Sestamibi project schedule.
On December 20,
2007, DRAXIS announced that DRAXIMAGE, its radiopharmaceutical division, has
appointed GE Healthcare, an industry leader in nuclear medicine, as the exclusive
distributor of DRAXIMAGE
®
Sestamibi in the U.S. DRAXIMAGE
®
Sestamibi is a generic kit for the preparation of Technetium (Tc-99m) Sestamibi
injection, a diagnostic cardiac imaging agent used in MPI to evaluate blood
flow to the heart.
DRAXIMAGE
has granted GE Healthcare the exclusive right to market, distribute and sell
its generic DRAXIMAGE
®
Sestamibi in the U.S. market and through its
U.S. and Canadian radiopharmacy network once the primary innovator patent
expires and marketing authorizations are received from the FDA and Health
Canada. Furthermore, GE Healthcare has agreed to purchase Technetium (Tc-99m)
Sestamibi injection exclusively from DRAXIMAGE. The initial term of the
distribution agreement is for a minimum of three years following FDA approval
of DRAXIMAGE
®
Sestamibi.
Technetium
Generators
A
second opportunity that is currently being pursued by DRAXIMAGE is the
production and distribution of MOLY-FILL
Ô
, a next-generation version of a Technetium Generator, which is the
source of Technetium in virtually every radiopharmacy worldwide. Nearly 90% of
generators are located in radiopharmacies, with the rest located in other
institutions, such as hospitals and clinics. DRAXIMAGE is in discussions
with potential development, marketing and manufacturing partners for its
MOLY-FILL Generator. During the fourth
quarter of 2007, the Company completed a test evaluation of the prototype
version of this product filed and the results of the evaluation will contribute
to the continuing product development process.
European
Entry
DRAXIMAGE
is continuing its efforts to obtain registrations in European markets for four
of its existing products that are currently approved and sold in Canada or the
U.S. In February 2005, DRAXIMAGE received approval from the Dutch
regulatory authority for its Kit for the Preparation of Technetium Tc-99m
Albumin Aggregated Injection (MAA Kit). Initial approval in the Netherlands
allowed DRAXIMAGE to initiate the Mutual Recognition Procedure (MRP) in
pursuit of further regulatory approvals for this product in several additional
European Union countries. This MAA Kit has since been approved in Germany,
the United Kingdom, Belgium, Austria and Luxembourg.
62
DRAXIMAGE MDP, a product used for bone imaging, has
been approved in the Netherlands, and Sodium Iodide I-131 therapeutic capsules
for the treatment of thyroid cancer has been approved in Denmark.
Additional
initial European approvals for the majority of other diagnostic imaging
products are anticipated during 2008. DRAXIMAGE has expanded its discussions
with respect to potential commercial partners to target the European markets
via strategic alliances. Strategic alliances could also potentially serve as a
means for DRAXIMAGE to expand its product catalogue in North America as well as
Europe. The Company expects discussions to continue during 2008.
Others
On August 22,
2007, DRAXIMAGE announced that it had established a research collaboration
agreement with Med Discovery of Switzerland to explore the combination of Med
Discoverys targeted protein therapeutics with DRAXIMAGEs radiopharmaceutical
expertise in the therapeutic and diagnostics field.
Med
Discoverys lead proteins are themselves potential therapeutic agents for prostate
cancer and a variety of other cancers. Initially, this collaboration will
provide for the radiolabelling of certain Med Discoverys proteins by DRAXIMAGE
to assess the enhancement of their therapeutic action and their capability to
detect micro tumors. The proteins will
be produced at Med Discoverys facility in Switzerland and radiolabelled by
DRAXIMAGE in Canada.
DRAXIMAGE
has also identified additional new product opportunities in the area of
non-radioactive contrast media that are used in the medical imaging field, and
is pursuing potential product development strategies to leverage both its
position in the marketplace and its preferred access to appropriate production
process expertise. Contrast media
products are injectable liquids produced in highly specialized cGMP sterile
production facilities, such as those in place at DRAXIS facilities, which are
currently used to produce certain diagnostic imaging products marketed by
DRAXIMAGE. The North American market for contrast media has been estimated to
be valued at approximately $1.6 billion, and we believe that it is growing
largely because of the continued growth of computer tomography (CT) and
enhanced magnetic resonance imaging (MRI) procedures.
DRAXIMAGE
has received approval from the FDA to run two clinical trials using radioactive
Iobenguane I-131 Injection (also known as 131I-metaiodobenzylguanidine, or
I-131 MIBG) to treat high-risk neuroblastoma, a rare form of cancer that mostly
affects infants and young children.
DRAXIMAGE
is providing I-131 MIBG for two clinical trials approved by the FDA under an
Investigational New Drug (IND) application. One trial is a Phase II study in
which I-131 MIBG is being administered with intensive chemotherapy and
autologous stem cell rescue for high-risk neuroblastoma patients. The second
trial is a Phase I study in which irinotecan and vincristine, two common
chemotherapy agents, are being administered in combination with I-131 MIBG to
determine safety and tolerability in patients with resistant/relapsed high-risk
neuroblastoma. Both trials are currently
under way.
Comparison of Years
Ended December 31, 2006 and 2005
Revenues
for the year ended December 31, 2006 increased by 11% (or close to 20%
excluding brachytherapy products, which the Company stopped selling late in
2005) compared to 2005, primarily as a result of the increase in product sales
from radioiodine products and, specifically, Sodium Iodide I-131 sales to the
U.S., including diagnostic capsules. The increase is related to higher volumes
resulting from greater U.S. market penetration.
63
On January 13,
2006, the Company received approval from the FDA regarding its supplemental new
drug application for Sodium Iodide I-131 Capsules USP, Diagnostic-Oral. These diagnostic Sodium Iodide I-131 capsules
are intended to be used by physicians to perform radioactive iodide uptake
tests to evaluate thyroid function prior to treatment with stronger therapeutic
doses of Sodium Iodide I-131. The Company introduced the new diagnostic
capsules into the U.S. marketplace during the second quarter of 2006 to
qualified/approved nuclear physicians and/or radiopharmacists.
For the
year ended December 31, 2006, product gross margin increased to 63% for
the year ended December 31, 2006 compared to 2005, reflecting the positive
impact of Sodium Iodide I-131 sales and the strategic focus on higher margin
products that led to the divestment of the brachytherapy product line in late
2005.
R&D
expenditures for the year ended December 31, 2006 as compared to 2005
increased 13% due to the ramping up of product development activities, in
particular activities related to DRAXIMAGE
®
Sestamibi and Technetium
Generators.
SG&A
expenses decreased by $0.3 million for the year ended December 31, 2006
compared to 2005 due mainly to one-time costs relating to the Companys exit from
the brachytherapy business during the fourth quarter of 2005.
Operating
income increased 47% to $5.6 million for 2006 as compared to 2005, driven by
increased volumes and margins as described above.
Depreciation
and amortization expense for this segment was relatively unchanged in nominal
dollars in 2006 compared to the year ended December 31, 2005.
Contract Manufacturing
(in thousands
of U.S. dollars) (U.S. GAAP)
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
54,926
|
|
$
|
64,731
|
|
$
|
54,743
|
|
|
|
|
|
|
|
|
|
Product gross margin
|
|
$
|
13,390
|
|
$
|
23,215
|
|
$
|
14,628
|
|
% of Product sales revenues
|
|
24.4
|
%
|
35.9
|
%
|
26.7
|
%
|
SG&A
|
|
(6,362
|
)
|
(6,487
|
)
|
(5,086
|
)
|
Depreciation and amortization
|
|
(4,390
|
)
|
(3,688
|
)
|
(3,105
|
)
|
Operating income
|
|
$
|
2,638
|
|
$
|
13,040
|
|
$
|
6,437
|
|
% of Revenues
|
|
4.8
|
%
|
20.1
|
%
|
11.8
|
%
|
Manufacturing
comprises the Companys manufacturing division, DRAXIS Pharma, which is a
pharmaceutical contract manufacturer with capabilities in a broad range of
dosage forms, specializing in liquid and lyophilized (freeze-dried) injectables
and other sterile products. Operating out of a cGMP-compliant 247,000
square-foot facility located in Montreal, Canada, DRAXIS Pharma manufactures
certain pharmaceutical products (specifically, cold kits) for DRAXIMAGE, as well
as for over 20 other pharmaceutical clients in many international
jurisdictions.
64
Comparison of Years Ended December 31,
2007 and 2006
For the
year ended December 31, 2007, revenues decreased by $9.8 million, or 15%,
over the same period of 2006. The decrease was due to lower sterile
manufacturing volumes, principally related to
Hectorol
®
for Genzyme as well as a return to historical volumes under the GSK contract,
following a ramp-up in late 2006 due to one-time increases in demand.
During
late 2007, the contract manufacturing division of DRAXIS continued to implement
procedures to reduce production delays that have in the past resulted in
shipments not being released in a timely manner impacting quarterly results for
most of 2007. While the Company has made improvements in expediting the process
times for orders, shifting customer shipment schedules and reprioritization of
projects associated with organizational changes, the improvements made to-date
partially removed the backlog of built-up demand. The procedures being put in
place to remove the backlog of demand to improve the product release cycle are
expected to improve operating performance on a quarter by quarter basis.
In
addition, volumes for 2007 were $1.0 million below the Companys expectations
due to a decision of a non-sterile customer to reduce its supply chain
inventory levels for 2007. The impact is expected to be a one-time reduction in
volumes for these non-sterile products with volumes returning to historical
levels thereafter.
As a
result of the signing of its material manufacturing contract with JJC for
non-sterile products, the Companys non-sterile production areas continue to
undergo significant activities to support product transfer requirements related
to this manufacturing contract. Included in this segments revenues are
approximately $2.6 million for 2007 in completed product transfer activities
related to the Companys new Johnson & Johnson Consumer contract. See New Johnson & Johnson Consumer
Contract.
Sterile
products represented 70% of total contract manufacturing revenues for 2007
compared to 80% for the year ended December 31, 2006.
Product
gross margin percentage decreased to 24% for the year compared to 36% for the
same period of 2006. The decrease was driven by lower sterile volumes impacting
margins through lower plant utilization and a lower percentage of sterile
volumes as part of the overall product mix.
SG&A
expenses for 2007 as compared to 2006 were flat as total severances costs of
$1.6 million were offset by the revaluation of incentive awards based on
current financial performance and cost savings related to head count
reductions.
Depreciation
and amortization for all of 2007 increased compared to the same period of 2006,
due to completion in 2007 of the installation and implementation of a new
warehouse management system which was part of the overall upgrade of the
Companys existing SAP platform and IT infrastructure.
Operating
income for 2007 was $2.6 million compared to operating income of $13.0 million
for the same period in 2006 due to lower sterile volumes and increased
severance costs, partially offset by a revaluation of incentive awards.
New
Johnson & Johnson Consumer Contract
During
the third quarter of 2007, the Company announced it had expanded its existing
contract manufacturing relationship with Johnson & Johnson Consumer
and entered into a new definitive supply agreement to provide commercial
manufacturing services for a broad portfolio of multiple non-sterile specialty
semi-solid products currently marketed in the U.S.
65
The new
multi-year contract runs to the end of 2013. It includes approximately two
years of manufacturing site transfer and process validation activities followed
by five years of commercial production, which is scheduled to begin in 2009.
Commercial production is expected to generate incremental revenues in excess of
$120 million over the five-year period of 2009 through 2013. The transfer of
equipment and production technologies, which is in progress, is expected to
generate additional cumulative revenues during 2007 and 2008 of approximately
$6 to $8 million. The contract also contemplates optional extensions beyond
2013.
FDA
Inspections
January 2007
Inspection
The
Company announced it received a notification from the FDA that the Companys
manufacturing operations in Montreal, Quebec continue to maintain their
classification as acceptable facilities following an extensive inspection by
the FDA in January 2007 of all six production and quality systems for the
contract manufacturing division.
October 2007
Inspection
The
Company also received notification from the FDA that the Companys
manufacturing operations in Montreal, Quebec continue to maintain their
classification as acceptable facilities following an extensive inspection by
the FDA in October 2007. The successful inspection was conducted
primarily with regard to two products manufactured on behalf of clients in the
DRAXIS Pharma sterile lyophilization (freeze-drying) production facility and in
DRAXIS Healths radiopharmaceutical business unit, DRAXIMAGE. There were no Form 483
Inspectional Observations issued during the FDA evaluation of DRAXIS systems.
Comparison of Years Ended December 31,
2006 and 2005
As
stated in prior disclosures, beginning in March 2006, production run rates
in the sterile area were back at levels expected for the contract manufacturing
operations prior to the shutdown issues of late 2005, and actually exceeded
previous normalized levels in part due to the contribution of the second
lyophilization unit, which came on line in 2005. The impact of the extended
shutdown in 2005 also negatively affected results for the fourth quarter of 2005.
Since the shutdown for 2006 was completed in the third quarter of 2006 as
planned, fourth quarter results for 2006 as compared to 2005 were significantly
stronger.
For the
year ended December 31, 2006, revenues increased by $10.0 million, or 18%,
over 2005. The increase was due to increased commercial production of
Hectorol
®
Injection
for
Genzyme growth in GSK volumes and increases in lyophilized product production.
For the
year ended December 31, 2006, sterile volumes accounted for 80% of product
revenues compared to 76% for 2005.
Product
gross margin percentage for the year ended December 31, 2006 increased to
36% compared to 27% for 2005, driven by a higher ratio of sterile to
non-sterile product revenues and the dilutive impact of the extended shutdown
on 2005 product gross margins. The extended shutdown period in 2005 negatively
affected product gross margin percentage by at least 5% during the second half
of 2005.
For the
year ended December 31, 2006, SG&A expenses rose by $1.4 million
compared to 2005 as a result of incentive plan accruals, the provision for past
due receivables and process improvement initiatives, including information
system and technology initiatives. Historically, the Company has not
66
incurred significant provisions for past due
receivables. SG&A expenses are also inflated for the year ended December 31,
2006 by the strengthening of the Canadian dollar relative to the U.S. dollar
for most of 2006 (relative to 2005), since the vast majority of SG&A
expenses are denominated in Canadian dollars.
Depreciation
and amortization for the year ended December 31, 2006 increased 19% over
2005, due principally to completed capital projects in 2005, which provided for
increased lyophilization and autoclave capacity.
Operating
income for all of 2006 increased to $13.0 million (20% of revenues) compared to
$6.4 million (12% of revenues) for 2005. The increase was driven by higher
product sales and product gross margins, partially offset by higher SG&A
expenses.
Corporate and Other
(in thousands
of U.S. dollars) (U.S. GAAP)
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
686
|
|
$
|
295
|
|
$
|
499
|
|
Intercompany eliminations
|
|
(2,756
|
)
|
(2,989
|
)
|
(1,543
|
)
|
Royalty and licensing
|
|
2,668
|
|
2,124
|
|
3,134
|
|
Anipryl
®
deferred
revenues
|
|
120
|
|
3,301
|
|
3,301
|
|
|
|
$
|
718
|
|
$
|
2,731
|
|
$
|
5,391
|
|
|
|
|
|
|
|
|
|
Product gross
margin
|
|
88
|
|
(186
|
)
|
(68
|
)
|
SG&A
|
|
(7,063
|
)
|
(8,558
|
)
|
(6,439
|
)
|
Depreciation and
amortization
|
|
(355
|
)
|
(337
|
)
|
(393
|
)
|
Operating loss
|
|
$
|
(4,542
|
)
|
$
|
(3,656
|
)
|
$
|
(465
|
)
|
The
Corporate and Other segment comprises: amortization of deferred revenues,
royalties and expenses associated with the Companys business agreements with
Pfizer Inc. with respect to
Anipryl
®
;
revenues related to royalties and milestones from Shire in connection with the
divestiture of DRAXIS Pharmaceutica; non-allocated corporate expenses; and
intercompany eliminations. The Company
follows a policy of not allocating its central corporate expenses to its
operating business segments.
Comparison of Years Ended December 31,
2007 and 2006
Revenues
related to the corporate segment were $2.0 million lower for 2007 compared to
2006 due mainly to the termination of the amortization of the vast majority of
Anipryl
®
deferred revenues on December 31,
2006. This was partially offset by the receipt of contingent milestone payments
of $0.8 million from Shire in the first quarter of 2007.
Intercompany
eliminations (related to the manufacture of lyophilized products by the
contract manufacturing segment for the radiopharmaceutical segment) vary as the
level of intercompany sales vary but do not impact segmented profitability.
Depreciation
and amortization expense in this segment for 2007 was flat as compared to the
same periods of 2006. Fluctuations are generally driven by changes to exchange
rates.
67
SG&A
expenses decreased $1.5 million for 2007 compared to 2006 due to the reduced
costs related to employee short- and long-term incentive plans (including
revaluation of the Deferred Share Unit Plan) which more than offset $0.7
million of severance costs in the fourth quarter of 2007.
Operating
loss for this segment was $0.9 million greater for 2007 relative to the same
period of 2006 as the decrease in
Anipryl
®
deferred revenues was only partially offset by a reduction in corporate
SG&A expenses. Severances costs in
SG&A expense as described above were more than offset by reduced costs
related to employee short- and long-term incentive plans.
Comparison of Years Ended December 31,
2006 and 2005
Corporate
revenues for the year ended December 31, 2006 were $2.7 million lower
compared to 2005 due to the receipt of a contingent milestone payment of $0.9
million from Shire included in 2005 results and higher intercompany
eliminations. Intercompany eliminations increased for the year ended December 31,
2006 compared to 2005 due to higher volumes of cold kits manufactured by the
contract manufacturing segment for the radiopharmaceutical segment.
As indicated
in prior disclosures, substantially all deferred revenues related to the
amortization of previously received
Anipryl
®
milestones terminated on December 31, 2006. The amortization of these
deferred revenues has previously resulted in non-cash revenues of $0.8 million
per quarter or $3.3 million per year.
Depreciation
and amortization expense in this segment in 2006 was relatively flat as
compared to 2005 since the Company had fully amortized product rights related
to the SpectroPharm
Ò
line in January 2005.
Operating
loss for the year ended December 31, 2006 was $3.2 million higher than for
2005 due to the receipt of a contingent milestone payment of $0.9 million from
Shire included in 2005 results, the inclusion of stock-based compensation costs
in SG&A expenses, effective January 1, 2006, and increased incentive
accruals for 2006.
Corporate Matters
Organizational
Changes
In July 2007,
the Company announced senior level organizational changes designed to further
streamline the Companys leadership and better reflect the core operating
businesses in Montreal. The Company
recorded severance charges in the contract manufacturing segment of $0.6
million which impacted results by approximately 1 cent per share in the third
quarter of 2007. The Company continued
to challenge its current organizational structure to reduce its overhead cost
structure and additional severance provisions of $1.7 million (or approximately
3 cents per share) were taken in the fourth quarter of 2007. The severance provisions include those
related to the decision to close the Companys Mississauga, Ontario office in
the first quarter of 2008.
New
CEO and COO
The
Board of Directors of DRAXIS appointed Mr. Dan Brazier as the new
President and Chief Executive Officer effective January 1, 2008. In addition, the Board appointed Mr. Jean-Pierre
Robert to the position of Chief Operating Officer of DRAXIS Health Inc.,
effective January 1, 2008. Mr. Robert
is also the President of DRAXIS Specialty Pharmaceuticals Inc. (DSPI).
68
On October 31,
2007, the Company had announced that Dr. Martin Barkin informed the Board
of Directors that he would retire as the President and Chief Executive Officer
of the Company effective December 31, 2007. For the period of January 1, 2008 to January 9,
2009, he will act as a Special Advisor to the Board of the Company.
Normal
Course Issuer Bids
On December 7,
2005, the Board of Directors of the Company authorized the repurchase for
cancellation of up to 3,522,530 of its common shares through a Normal Course
Issuer Bid, which represented 10% of the public float on December 6,
2005. In accordance with the rules of
the Toronto Stock Exchange (TSX), such purchases could begin on December 15,
2005 and end no later than December 14, 2006.
The
Company received approval from the TSX on December 18, 2006 to renew its
Normal Course Issuer Bid (the 2006 Issuer Bid) until December 19, 2007.
No
shares were purchased in 2006 in accordance with the 2006 Issuer Bid. As at December 19, 2007, the date of the
termination of the 2006 Issuer Bid, the Company had repurchased 130,100 common
shares under the 2006 Issuer Bid.
DRAXIS
has received approval from the TSX for its Normal Course Issuer Bid (the 2008
Issuer Bid) to purchase up to 4,072,054 common shares, which represent
approximately 10% of the 40,720,539 common shares in the public float as at January 14,
2008.
The
2008 Issuer Bid will end no later than January 20, 2009 or earlier if the
Company purchases the maximum allowable number of common shares. All shares
will be purchased through the facilities of the TSX and will be cancelled. Subject to any block purchases made in
accordance with the rules of the TSX, the Company is subject to a daily
repurchase restriction of 23,084 common shares, which represents 25% of the
average daily trading volume of the Companys common shares for the six months
ended December 31, 2007.
Any
purchases made pursuant to the 2008 Issuer Bid will be made in accordance with
the rules of the TSX and will be made at the market price of the common
shares at the time of the acquisition.
As of March 18, 2008, the Company had not purchased any common
shares under the 2008 Issuer Bid.
Permax
®
Litigation
On July 22,
2005, the Company announced that, together with other defendants, it had
received a Statement of Claim filed before the Superior Court of Justice of
Ontario wherein the plaintiff alleges that
Permax
®
,
a drug that the Company distributed in Canada for a third-party manufacturer
prior to July 2003, causes compulsive/obsessive behaviour, including
pathological gambling. The plaintiff is seeking to have this action certified
as a class action. The Company believes
this claim against it is without merit and intends to vigorously defend this
proceeding and any motion for certification.
Prior to July 2003,
Permax
®
was distributed in Canada by DRAXIS Pharmaceutica, the Canadian pharmaceutical
sales and marketing division of the Company. In July 2003, the Company
completed the divestiture of the DRAXIS Pharmaceutica division to Shire. No
provisions have been taken pursuant to this claim.
On February 29,
2008, the plaintiff served an Amended Statement of Claim and a Motion Record in
support of the plaintiffs motion for certification of this action as a class
proceeding. The defendants must file a
response to plaintiffs motion for certification by July 31, 2008.
69
Disclosure
Controls and Procedures
As of December 31,
2006 and 2007, an evaluation was carried out, under the supervision of and with
the participation of management, including the President and Chief Executive
Officer and the Chief Financial Officer, of the effectiveness of the Companys
disclosure controls and procedures as defined in Multilateral Instrument 52-109,
pursuant to Canadian regulatory requirements and in Rule 13a-15(e) or
15d-15(e) under the
U.S. Securities
Exchange Act
of 1934, as amended (the
Exchange Act
). Based
on that evaluation, the President and Chief Executive Officer and the Chief
Financial Officer concluded that the design and operation of these disclosure
controls and procedures were effective.
During
2006 and 2007, the Company completed an evaluation of the design of internal
controls over financial reporting as required under Multilateral Instrument
52-109 and Rule 13a-15(e) or 15d-15(e) of the
Exchange Act
. Based on the results of the
evaluation, the President and Chief Executive Officer and Chief Financial
Officer concluded that the internal controls over financial reporting are designed
to provide reasonable assurance that the Companys Consolidated Financial
Statements for external purposes in accordance with U.S. GAAP are
reliable. See Item 15 Controls and
Procedures.
The
Company has concluded that during the fiscal years ended December 31, 2007
and December 31, 2006, there were no changes made to internal controls
over financial reporting that have materially affected, or are reasonably
likely to materially affect, the Companys internal controls over financial
reporting.
Liquidity and Capital
Resources
(in thousands of U.S. dollars) (U.S. GAAP)
Years
ended December 31
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
24,796
|
|
$
|
21,446
|
|
$
|
12,390
|
|
Restricted cash
|
|
$
|
1,326
|
|
|
|
|
|
Non-financial
working capital (net)
(1)
|
|
$
|
21,252
|
|
$
|
21,247
|
|
$
|
18,890
|
|
Total debt
(current and long term)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities
|
|
$
|
12,551
|
|
$
|
16,450
|
|
$
|
9,717
|
|
Cash flows used
in investing activities
|
|
$
|
(13,394
|
)
|
$
|
(5,993
|
)
|
$
|
(4,380
|
)
|
(1)
|
Excluding
cash and cash equivalents, restricted cash, current portion of deferred
revenues and customer deposits
.
|
|
|
Feb 29, 2008
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
|
|
Common shares
issued and outstanding
|
|
42,062,538
|
|
42,062,538
|
|
41,522,138
|
|
41,588,005
|
|
Warrants issued
and outstanding
(2)
|
|
|
|
|
|
|
|
1,526,718
|
|
Stock options
outstanding
|
|
2,135,828
|
|
1,875,828
|
|
2,257,995
|
|
2,652,620
|
|
Outstanding
options as a % of outstanding shares
|
|
5.1
|
%
|
4.5
|
%
|
5.4
|
%
|
6.4
|
%
|
(2)
|
Each whole warrant entitled the holder to
acquire one common share at a price of CDN$8.50, subject to certain
adjustments, any time prior to April 24, 2006. All warrants expired
unexercised on April 24, 2006.
|
Cash
and cash equivalents at December 31, 2007 totalled $24.8 million as
compared with $21.4 million as at December 31, 2006. The increase is attributable to the
cumulative effect of cash earnings of the Company and proceeds from the
exercise of stock options and customer financing, offset by capital
expenditures. Cash and cash equivalents as of December 31, 2006 totalled
$21.4 million as compared with $12.4 million as of December 31, 2005. The increase was attributable to the
increasing cash earnings of the Company and proceeds from the exercise of stock
options, offset by capital expenditures and funds used to buy back the
Companys shares under the 2006 Issuer Bid.
70
The
Company follows a policy of investing its surplus cash resources in high
quality, liquid, short-term commercial paper and government treasury bills and
money market mutual funds, which invest in high quality short-term
securities. All investments as of December 31,
2007 and 2006 had less than three months maturity. As at December 31, 2007 and 2006, there
were no restrictions on the flow of these funds nor have any of these funds
been committed in any way.
For the
year ended December 31, 2007, cash flows from operating activities were
$12.6 million compared to $16.4 million for the same period of 2006. The decrease was related to lower cash
earnings in the contract manufacturing segment.
For the
year ended December 31, 2006, net operating cash flows were $16.4 million
compared to $9.7 million for 2005. The year-over-year increases in net
operating cash flows have been driven by increased volumes in the Companys two
core businesses, partially offset by a higher investment in working capital.
The
Company believes it has sufficient working capital to meet its present
operational requirements.
Non-financial
working capital, comprising accounts receivable, inventories, prepaid expenses,
current deferred income tax assets, accounts payable and accrued liabilities,
as at December 31, 2007 remained relatively unchanged compared to December 31,
2006 due to a significant reduction in outstanding receivables related to lower
volumes for 2007, offset by increases in semi-finished and finished inventory
levels in the contract manufacturing segment.
Non-financial
working capital, comprising accounts receivable, inventories, prepaid expenses,
current deferred income tax assets, accounts payable and accrued liabilities,
as at December 31, 2006 increased compared to December 31, 2005 due
mainly to increased receivable levels related to volume growth and timing of
collection of receivables.
Capital
expenditures during 2007 and the increase compared to 2006 are mainly
attributable to the JJC supply agreement signed in the third quarter of 2007,
information technology and SAP platform upgrades and a new warehouse management
system.
Capital
expenditures for the year ended December 31, 2006 are mainly attributable
to expenditures to improve operating efficiencies in production areas and to
increase manufacturing capacity and infrastructure upgrades, namely to the
Companys information technology and SAP platforms.
Proceeds
from the issuance of treasury common shares by the Company attributable to the
exercise of options generated $2.1 million for the year ended December 31,
2007 compared with $1.9 million and $1.6 million for 2006 and 2005
respectively.
During
2007, 130,100 shares were purchased under the 2006 Issuer Bid (which terminated
on December 19, 2007) at a cost of $686,000.
71
The following table
summarizes the Companys major contractual cash obligations as of December 31,
2007:
Contractual
Obligations
|
|
|
|
|
|
|
|
Payment due by end of:
|
|
|
|
|
|
|
|
Total
|
|
2008
|
|
2009
|
|
2010
|
|
2011
|
|
2012
|
|
Thereafter
|
|
Operating leases
|
|
3,955
|
|
399
|
|
595
|
|
570
|
|
566
|
|
566
|
|
1,259
|
|
Service
contracts
|
|
1,339
|
|
591
|
|
358
|
|
193
|
|
124
|
|
60
|
|
13
|
|
Total contractual
obligations
|
|
5,294
|
|
990
|
|
953
|
|
763
|
|
690
|
|
626
|
|
1,272
|
|
All
contractual obligations related to 2007 and 2006 were fully paid as of December 31,
2007 and December 31, 2006, respectively.
In
addition to the above, the Company may be obligated to make certain royalty
payments based on related product sales and milestone payments based on the
achievement of certain specified events.
The
amount, timing and likelihood of these royalty payments are not determinable as
they mainly relate to products being developed and not yet approved by the
applicable regulatory authorities.
Bank Financing
The
Company chose not to renew its credit facilities upon their scheduled
expiration date in June 2007. The Company plans to explore new credit
facility arrangements in conjunction with new business opportunities. The
Company believes that its current cash position and cash flows are sufficient
to achieve the Companys business plans.
Customer Financing
During
2007, the Company received $1.6 million in U.S. dollar-denominated customer
financing related to capital installation activities being performed to
transfer in products to the contract manufacturing operations under the
Companys new contract with a major customer. The customer financing will be
drawn down as commercial batches are produced under the contract. The customer
financing will be secured by the specific capital installations made in
preparation for this contract.
Off-Balance Sheet
Arrangements
The
Company does not have any off-balance sheet arrangements that have, or are
reasonably likely to have, a current or future effect on the Companys
financial condition, changes in revenues or expenses, results of operations,
liquidity, capital expenditures or capital resources that are material to
investors.
Related Party
Transaction
The
Company paid rent of $131,000 during 2007 (2006 - $127,000; 2005 - $123,000) to
a company controlled by a member of the Board of Directors, related to the
lease of its registered office location.
This
transaction is in the normal course of operations and is measured at the
exchange amount as agreed to by the parties based on market rates per square
footage for similar space. The lease expired in May 2006, and lease
payments continue on a monthly basis. The Company terminated the lease and will
vacate the premise as part of the closing of the Mississauga office location in
the first quarter of 2008.
72
SELECTED CONSOLIDATED
ANNUAL INFORMATION
(in
thousands of U.S. dollars, except share related data) (U.S. GAAP)
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
76,072
|
|
$
|
83,545
|
|
$
|
72,989
|
|
Royalty and licensing
|
|
2,668
|
|
2,121
|
|
3,143
|
|
Anipryl®
deferred revenues
|
|
120
|
|
3,301
|
|
3,301
|
|
|
|
$
|
78,860
|
|
$
|
88,967
|
|
$
|
79,433
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$
|
1,658
|
|
$
|
11,547
|
|
$
|
7,784
|
|
|
|
|
|
|
|
|
|
Basic
earnings per share
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.19
|
|
|
|
|
|
|
|
|
|
Diluted
earnings per share
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.18
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
127,934
|
|
$
|
105,962
|
|
$
|
95,820
|
|
Total long-term
financial liabilities
|
|
$
|
3,299
|
|
$
|
990
|
|
$
|
308
|
|
SUMMARY
OF QUARTERLY RESULTS
(in
thousands of U.S. dollars, except share related data) (U.S. GAAP)
|
|
Q4, 2007
|
|
Q3, 2007
|
|
Q2, 2007
|
|
Q1, 2007
|
|
Q4, 2006
|
|
Q3, 2006
|
|
Q2, 2006
|
|
Q1, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
20,024
|
|
$
|
17,370
|
|
$
|
19,048
|
|
$
|
19,630
|
|
$
|
23,106
|
|
$
|
19,788
|
|
$
|
23,003
|
|
$
|
17,648
|
|
Royalty and licensing
|
|
433
|
|
558
|
|
359
|
|
1,318
|
|
465
|
|
617
|
|
437
|
|
603
|
|
Anipryl®
deferred revenues
|
|
30
|
|
30
|
|
30
|
|
30
|
|
825
|
|
825
|
|
825
|
|
825
|
|
|
|
$
|
20,487
|
|
$
|
17,958
|
|
$
|
19,437
|
|
$
|
20,978
|
|
$
|
24,396
|
|
$
|
21,230
|
|
$
|
24,265
|
|
$
|
19,076
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income
|
|
$
|
(551
|
)
|
$
|
(1,376
|
)
|
$
|
1,575
|
|
$
|
2,010
|
|
$
|
3,687
|
|
$
|
2,604
|
|
$
|
3,564
|
|
$
|
1,692
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted (loss)
earnings per share
|
|
$
|
(0.01
|
)
|
$
|
(0.03
|
)
|
$
|
0.04
|
|
$
|
0.05
|
|
$
|
0.09
|
|
$
|
0.06
|
|
$
|
0.09
|
|
$
|
0.04
|
|
MAJOR
TRENDS IN QUARTERLY NUMBERS
The quarterly numbers reflected in the table above reflect
the significant trends described below. For more detailed explanations, please
refer to managements discussion and analysis of financial condition and
results of operations (MD&A), filed on a quarterly basis on SEDAR and
with the United States Securities and Exchange Commission on Form 6-K. The MD&A for the quarter ended December 31,
2007 is incorporated herein by reference.
Commencing
in the second quarter of 2003, the contract manufacturing segment began a
significant ramp-up of shipments of
Hectorol
®
Injection
for Genzyme and products under its GSK
manufacturing agreements. This resulted in a positive upward trend in revenue
mainly in contract manufacturing and increasing margins due to the higher
margin sterile business and the financial benefits of improved capacity
utilization. The major trend in revenues has been the shift in business in
contract
73
manufacturing where sterile product revenue occupies a
higher share of overall revenue driven by the GSK and Genzyme business. This
trend continued through 2004 and into the third quarter of 2005. The result was
increasing volume and associated product gross margins in contract
manufacturing.
However,
during the third quarter of 2005, the Companys contract manufacturing
operation extended its scheduled shutdown period at the beginning of the third
quarter in the sterile area in order to correct an electrical panel failure and
make associated repairs. The decision to
revalidate the entire sterile area following these repairs and to recalibrate
production schedules had material financial implications that hindered third
and fourth quarter results in 2005. Finalizing and executing production
schedules in the fourth quarter of 2005 was further hindered by delays in
receiving some component materials from suppliers. Production in contract
manufacturing was ramping up towards normalized production levels by the end of
the third quarter of 2005. The overall
effect of the extended shutdown was to negatively affect the Companys key
financial metrics over the second half of 2005 and offset the significant
growth achieved over 2004 in the first half of 2005. The impact on product
gross margins in the second half of 2005 was approximately 5%. The peripheral impacts of the extended
shutdown, specifically as it related to production scheduling, impacted overall
results into February 2006.
Beginning
March 2006, the Company returned to normalized production volumes. The
contract manufacturing segment began achieving significant volume growth
beginning with the second quarter of 2006 and extending to the end of 2006. The
growth was driven by the sterile products area, in particular, by volume from
two major customers, Genzyme and GSK. In addition, the Company benefited from
the effects of the contribution of additional lyophilization capacity for 2006,
which increased sterile lyophilization volumes in 2006 relative to 2005. Third
quarter results for 2006 reflected the impact of a normal shutdown period in
contract manufacturing. As the 2006 shutdown was completed on plan, the Company
was able to return to volumes achieved in the second quarter of 2006 by the
fourth quarter.
During
2007, volumes were significantly impacted by a change in forecasted volumes by
Genzyme, which resulted in an overall reduction in
Hectorol
®
Injection
volumes by $9 million (excluding currency
fluctuations) compared to 2006 levels. The volume reductions resulted in a
significant reduction in
Hectorol
®
Injection
volumes throughout 2007 with the largest impact
being the third quarter of 2007. Volumes increased in the fourth quarter of
2007 over the third quarter of 2007, but did not return to the record levels of
the fourth quarter of 2006. In addition, volumes under the GSK contract also
decreased over 2006 levels due to a one-time increase in volumes over
historical levels occurring in the fourth quarter of 2006.
Lower
contract manufacturing margins were directly related to the reduced sterile
volumes as described above. Sterile volumes are higher margined volumes
compared to non-sterile volumes.
In the
radiopharmaceutical segment, volumes have increased since the first quarter of
2003, relating to the introduction of Sodium Iodide I-131 to the U.S., and the
primary driver for growth in 2005 remained the increasing penetration of Sodium
Iodide I-131 in the U.S. Radioiodine sales (Sodium Iodide I-131) continued to
drive sales growth in 2006 via increased U.S. market penetration, including the
introduction of diagnostic capsules into the U.S. marketplace.
Volumes
of radioactive products produced by the radiopharmaceutical operations were
lower than expected during 2007 due to a decision by a customer to temporarily
suspend production of a private label radioactive product (representing a loss
of $350,000 in revenues per quarter). This decision began impacting results in
the second half of 2007.
In
addition, during the second quarter of 2007, Sodium Iodide I-131 sales were
reduced due to the inability of its supplier to provide radioisotopes. An
alternative supplier was found and approved as a
74
result. However, due to an extended shutdown at one of
the largest global suppliers of radioactive isotopes in December, overall
demand for product was down in the fourth quarter. The extended shutdown was
over by the end of 2007.
Overall,
margins increased in 2006 over 2005 due to the decision in late 2005 to
discontinue sales of brachytherapy products that diluted margins previously.
Margins
decreased in 2007 due mainly due to a strengthening Canadian dollar, and to a
lesser extent, the dilutive effect of including freight charges in both
revenues and cost of goods sold beginning with the second quarter of 2007.
Substantially
all revenues related to the amortization of previously received
Anipryl
®
milestones terminated on December 31,
2006. The amortization of these deferred revenues previously resulted in
non-cash revenues of $0.8 million per quarter, contributing approximately 7
cents per share per full year. The termination of this source of non-cash
revenue and operating income has no effect on cash flows but affects
quarter-over-quarter and year-over-year comparisons of operating results
beginning with the first quarter of 2007 (see Corporate and Other).
Apart
from the impact of foreign currency on the Companys Canadian-denominated
SG&A spending, SG&A spending increased in 2005 due to costs of process
improvement initiatives commencing in the second quarter of 2005; one-time
costs associated with the exit of the brachytherapy product line, which
occurred in the fourth quarter of 2005; and severance costs in the fourth
quarter of 2005. Effective January 1,
2006, the Company included stock-based compensation costs in SG&A expenses
as a non-cash item. This had the effect of lowering EPS by 0.5 cents for 2006
and 2007, relative to the preceding quarter (pre-2006). Fourth quarter 2006
results were impacted by accruals for long-term incentive plan awards based on
the Companys financial performance in 2005. During 2007, SG&A expenses
were impacted relative to 2006 by lower incentive accruals related to both
short- and long-term incentive programs. The Company incurred severance costs
of approximately $0.6 million in the third quarter and $1.7 million in the
fourth quarter of 2007.
Depreciation
and amortization costs continue to rise over time. This reflects the capital
expenditure programs implemented since 2002. This trend continued,
specifically, as the second lyophilization unit was fully installed and
validated in the first half of 2005.
Foreign
exchange has impacted EPS by the strengthening Canadian dollar and its effect
on the Companys net monetary position held in U.S. dollars for 2007, resulting
in a foreign exchange loss of $1.7 million during 2007 which mostly occurred
during the second and third quarters of 2007. The Canadian dollar weakened late
in 2006 resulting in a foreign exchange gain on U.S. dollar-denominated net
monetary items.
Interest
income has increased and become more significant as the Company eliminated debt
levels at the end of 2004 and built up its interest bearing cash position since
then.
The
Companys effective tax rate has been significantly below the statutory rate
due to the level of research and development spending, giving rise to tax
credits which reduce the overall tax provision of the Company. Specifically in
2005, the Company benefited from the recognition of the lower effective
statutory tax rate attributable to milestone payments received and through
withholding tax refunds received in the year, but not previously estimated to
be recoverable, offset by changes to statutory tax rates resulting in one-time
adjustments to the deferred income tax values. As expected, during 2006 and
2007 income taxes moved closer to statutory levels less the positive impact of
tax credits received on R&D expenditures.
75
Net
cash flow from operating activities continues to grow with the increased
volumes, subject to the required investment in working capital to support the
ramp-up in business. Net operating flows
tend to be higher in the latter half of a year as incentive awards, insurance
payments and tax installments tend to be made early in a year.
Capital
expenditures tend to rise during and after shutdown periods (usually in the
third quarter) when most installation activities take place. Information
technology and SAP spending to upgrade both platforms accelerated in the second
half of 2006. Capital expenditure spending increased in 2007 due to the
completion of information technology and SAP platform upgrades (including a new
warehouse management system) during the first half of 2007. Spending during the
second half of 2007 was largely related to preparation for the Companys new
business coming from the JJC contract.
OUTLOOK
The following section contains numerous forward-looking
statements specifically pertaining to guidance. Management has included a
narrative of the underlying factors and assumptions on which the
forward-looking statements are based. While management believes that the basis
for these forward-looking statements is reasonable, they are based on
information currently available to management and, accordingly, actual results
could differ materially from the forward-looking statements (see
Forward-Looking Statements
below for
factors which could cause our results or performance to differ materially from
a conclusion, forecast or projection in the forward-looking statements).
The
Companys ability to forecast revenue over shorter-term periods, especially
quarterly targets, is very difficult and less accurate during periods in which
significant changes are made to production schedules, whether due to production
issues or changes to the size or timing of customer demand. While delays in
receiving component parts are not unusual, when combined with production issues
or customer timing changes, they can significantly impact revenues compared to
forecasts for a given period. Furthermore, due to the complexity of sterile
manufacturing and the rigours and demands of the quality testing and release
process, anticipated shipment dates and the accompanying revenues can change from
period to period based on the independent quality control process. Accordingly, the Company does not plan to
provide either specific quarterly guidance or revenue guidance.
Outlook
and Guidance Intentions
Guidance
targets for 2007, which were revaluated during the course of 2007, were not
achieved as a result of the following factors:
·
Subsequent to the second quarter of 2007, an
ongoing assessment of the Companys cost structure began with the appointment
of Jean-Pierre Robert as President of DSPI, thereby responsible for the
Companys operating units. In addition, a parallel review of the Companys
corporate overhead structure was initiated to reduce overhead costs and
eliminate redundancies Company-wide. This is related to the higher cost burden associated
with these costs as a result of the stronger Canadian dollar, the upgrade of
our SAP systems and overall plans to achieve greater efficiencies. During the
course of 2007, the Company took severance cost provisions of $1.6 million in
contract manufacturing and $0.7 million in its corporate segments as a result,
including the decision to close its Mississauga office location in early 2008.
·
During 2007, the strengthening of the Canadian
dollar from CDN$1.165 per U.S. dollar as at December 31, 2006 to CDN$0.991
per U.S. dollar as at December 31, 2007 has resulted in foreign exchange
losses for all of 2007 of approximately 3 cents per share, or $1.7 million.
This foreign exchange loss resulted from the revaluation of U.S.
dollar-denominated net monetary assets.
76
·
Since the vast majority of the Companys cost
structure is in Canadian dollars and a larger portion of the Companys revenue
streams is denominated in U.S dollars, the strengthening of the Canadian dollar
has a significant negative impact on the Companys underlying gross profit
margin and operating expenses. We estimate that the strengthening of the
Canadian dollar has reduced operating profitability by approximately 3 to 4
cents per share on an annual basis relative to 2006.
·
Volumes of radioactive products produced by the
radiopharmaceutical operations were lower than expected for the second half of
2007 due to a decision by a customer to cease production of a private label
radioactive product (which historically represented $350,000 in revenues per quarter),
while the customer determines whether to continue to supply the market in the
future pending possible formulation changes.
·
During the course of 2007, two separate
shortages for the supply of radioactive isotopes occurred which impacted the
financial performance of the radiopharmaceutical segment. The first shortage
resulted in the Company obtaining the approval of a secondary source of supply
for the U.S. market. The second shortage created an industry-wide decrease in
demand in late 2007 for radioactive procedures due to a short supply in the
marketplace of radioisotopes as the key ingredient.
·
Hectorol
®
production volumes in
2007 were $9 million lower than what they were in 2006 and
significantly lower than what was
originally forecasted for 2007. It is our understanding that these volumes may
still vary materially either positively or negatively in future quarters as a
result of continued uncertainty in customer demand. The lower than expected volumes from Genzyme
have offset the positive impact of increased volumes related to new business
activities taking place during 2007 within our contract manufacturing
division. We believe that the trend is
for
Hectorol
®
volumes to
ultimately be phased out during 2009. We also anticipate quarterly fluctuations
in volume which may not be predictable.
The
contract manufacturing segment began to implement procedures, including organizational
changes, to reduce production delays that have in the past resulted in
shipments not being released in a timely manner, impacting quarterly results
for most of 2007.
While
short-term financial performance for 2007 was below the Companys expectations,
the Company did achieve significant key milestones consistent with the sources
of future growth for the Company in future years.
Guidance
for Future Years
The
Company expects progressively improving financial results during 2008 compared
to 2007 as a result of increased demand through new business opportunities,
product introductions and additional contracts. This is expected to result in
continuing year-over-year growth in revenues, operating income, and cash flows
going forward, starting from a base in 2008. Net earnings per share for 2008
are expected to increase significantly over 2007. However, the extent to which the Company can
reasonably predict the financial performance for 2008 is limited due to variables
outside of the control of the Company. Accordingly, the Company does not plan
to provide specific quantitative guidance given the anticipated period of
expansion and significant growth that is expected to be accompanied by periods
of increased forecast variability due to several factors, including the
following:
·
The timing and ramping-up of commercial
production of non-sterile products under the new contract with Johnson &
Johnson Consumer will be influenced by both the product transfer process and
the receipt of manufacturing site transfer approvals from appropriate
regulatory agencies.
·
We do expect revenue growth associated with
product transfer activities for 2008 but, while such activities will generate
positive margins, the margin percentage is expected to be dilutive to overall
margins as we hire and train new personnel in anticipation of the commercial
phase of the contract.
77
·
Several potential new business opportunities
have been identified as a result of increased marketing and outreach activities
initiated during 2007. However the rate of conversion of such opportunities to
new business contracts over the next several quarters has introduced increased
forecasting variability.
·
The timing and extent of radiopharmaceutical product
introductions to European markets is highly dependent on receiving timely
regulatory approvals, although additional approvals are expected during 2008,
in several different countries. The
Company is actively working to establish one or more appropriate marketing and
distribution partnerships, which will influence the rate at which product sales
will grow in the European Union markets.
·
Revenue and earnings from the potential
introduction of DRAXIMAGE
®
Sestamibi will depend on several factors
including regulatory approvals, competitive activity, manufacturing execution,
marketing and distribution partnerships, and market acceptance following
product launch. This is expected to be a
significant product for the Company and the variability around its introduction
alone is expected to impact the accuracy of future forecasts for 2008 and 2009.
·
The potential introduction of the MOLY-FILL Technetium
Generator is expected to be a significant event given the limited product
offerings currently available, and the forecast variability associated with
this product is highly dependent on somewhat unpredictable factors including
regulatory approvals, marketing and/or distribution agreements, pricing
strategies and market penetration rates.
The
Company will provide updates to the extent possible as these opportunities
evolve and if possible quantify the potential impact of each factor as they
become more transparent as to timing and quantum.
Other
The
Board of Directors believes that the Companys shares trade, from time to time,
well below their real value and that the trading price of the common shares
does not reflect the potential inherent value in the Companys core
competencies. Accordingly, as mentioned
above under Corporate Matters, the Board of Directors in January 2008
authorized the 2008 Issuer Bid and will continue to consider other strategies
to enhance the trading value of its common shares.
ACCOUNTING
MATTERS
Critical
Accounting Policies and Estimates
The
foregoing discussion and analysis of the financial condition and results of
operations are based upon the Companys Consolidated Financial Statements,
which have been prepared in accordance with U.S. GAAP. The preparation of
Consolidated Financial Statements requires the Company to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingent assets and liabilities. On an
ongoing basis, the Company evaluates its estimates and makes adjustments as
appropriate. Actual results may differ from these estimates.
A
summary of the significant accounting policies and methods used by the Company
in the preparation of its Consolidated Financial Statements is included in
Notes 2 and 3 to the 2007 audited Consolidated Financial Statements. The
Company believes the following critical accounting policies affect its more
significant judgments and estimates used in the preparation of its Consolidated
Financial Statements.
Recognition
of Licensing Revenue
License
and other forms of non-refundable fees received pursuant to collaboration
agreements are accounted for according to the related contractual agreements.
In general, such fees are deferred and recognized on a straight-line basis over
the contract period. Where the contract period is not defined, such
78
fees are recognized on a straight-line basis over the
estimated term, during which contractual benefits are expected to be derived.
If payment of such fees is contingent upon future performance obligations of
the Company or other future events, revenue recognition of such amounts is
deferred and recognized upon completion of the specific event.
Deferred
Tax Assets
Realization
of the net deferred tax assets is dependent on the Companys ability to
generate sufficient taxable income in certain tax jurisdictions. Management
believes that it is more likely than not that the assets will be realized,
based on forecasted income. On a
quarterly basis, the estimates and assumptions underlying the forecasted income
are reviewed by management to determine whether additional valuation allowances
are warranted or valuation allowances are still required. The Company has taken
valuation allowances related to tax loss carryforwards in jurisdictions where
taxable income is no longer generated, it is not likely to generate sufficient
taxable income in Canada to utilize Canadian tax loss carryforwards prior to
expiry, and filing positions taken with taxation authorities are subject to
review. Changes to estimates of future taxable income, the completion of
reviews by taxation authorities and the ability to execute on tax-planning opportunities
can significantly affect the amount of valuation allowances.
Allowance
for Doubtful Accounts
The
Company determines an appropriate allowance for doubtful accounts based on an
account-by-account review as opposed to a general provision assessed as a
percentage of revenues.
Provision
for Inventory Obsolescence
Provisions
for inventory are charged against income when it is determined that specific
inventory items do not meet the defined quality and regulatory requirements for
sale. The Company does not make general
provisions for inventory obsolescence.
Foreign
Exchange Risk
The Companys reporting
currency is U.S. dollars. The functional currency for its Canadian operations -
which include the radiopharmaceutical segment, the contract manufacturing
segment and royalties and milestones related to product rights sold to Shire - is
the Canadian dollar. Accordingly, the Companys foreign exchange exposure for
accounting purposes mainly relates to U.S.-denominated monetary assets of these
operations. The Company currently does not actively hedge this exposure, but
reduces the exposure by maintaining the minimum level of U.S.-denominated cash
available to meet its short-term cash requirements.
Recent
Accounting Pronouncements
In February 2007, the Financial Accounting Standard Board (FASB)
issued SFAS No. 159,
The Fair Value
Option for Financial Assets and Financial Liabilities
. This statement permits entities to choose to
measure many financial instruments and certain other items at fair value. The objective is to improve financial
reporting by providing entities with the opportunity to mitigate volatility in
reported earnings caused by measuring related assets and liabilities
differently without having to apply complex hedge accounting provisions. The Company was required to adopt the
provisions of SFAS No. 159, effective January 1, 2008. The Company does not anticipate that the
election, if any, of this fair-value option will have a material effect on the
Consolidated Financial Statements.
In September 2006, FASB issued SFAS No. 157,
Fair Value Measurements
. This statement provides guidance for using
fair value to measure assets and liabilities.
It also responds to investors request for expanded information about
the extent to which companies measure assets and liabilities at fair value, the
information used to measure fair value, and the effect of fair value
measurements on
79
earnings. SFAS No. 157 applies whenever other
standards require (or permit) assets or liabilities to be measured at fair
value, and does not expand the use of fair value in any new circumstances. The
Company was required to adopt the provisions of SFAS No. 157 effective January 1,
2008. The Company does not believe that
its adoption will have a material impact on the Companys Consolidated
Financial Statements.
Forward-Looking
Statements
This
MD&A contains forward-looking statements within the meaning of Section 27A
of the
Securities Act of 1933
, as amended (the
Securities Act) and Section 21E of the
Securities
Exchange Act of 1934
, as amended (the Exchange Act) and as
contemplated under other applicable securities legislation. These statements can be identified by the use
of forward-looking terminology such as may, will, expect, anticipate,
estimate, continue, plan, intend, believe or other similar words.
These statements discuss future expectations concerning results of operations
or financial condition or provide other forward-looking information. Our actual
results, performance or achievements could be significantly different from the
results expressed in, or implied by, those forward-looking statements. You
should not place undue reliance on any forward-looking statement, which speaks
only as of the date made.
These
statements are not guarantees of future performance. By their nature,
forward-looking statements involve numerous assumptions, known and unknown
risks, uncertainties and other factors that may cause the actual results or
performance of the Company to be materially different from such statements or
from any future results or performance implied thereby. Factors that could
cause the Companys results or performance to differ materially from a
conclusion, forecast or projection in the forward-looking statements include,
but are not limited to:
·
Those related to discussions involving a
potential transaction that could lead to a sale of the Company;
·
the achievement of desired clinical trial
results related to the Companys pipeline products;
·
timely regulatory approval of the Companys
products;
·
the ability to comply with regulatory
requirements applicable to the manufacture and marketing of the Companys
products;
·
the Companys ability to obtain and enforce
effective patents;
·
the non-infringement of third party patents or
proprietary rights by the Company and its products;
·
factors beyond our control that could cause
interruptions in our operations in our single manufacturing facility
(including, without limitation, material equipment breakdowns);
·
reimbursement policies related to health care;
·
the establishment and maintenance of strategic
collaborative and commercial relationships;
·
the Companys dependence on a small number of
key customers;
·
the disclosure of confidential information by
our collaborators, employees or consultants;
·
the preservation of healthy working
relationships with the Companys union and employees;
·
the Companys ability to grow the business;
·
the fluctuation of our financial results and
exchange and interest rate fluctuations;
·
the adaptation to changing technologies;
·
the loss of key personnel;
80
·
the avoidance of product liability claims;
·
the loss incurred if current lawsuits against us
succeed;
·
the volatility of the price of our common
shares;
·
market acceptance of the Companys products;
·
factors described under Outlook above; and
·
the risks described in Item 3. Key Information -
Risk Factors in this Annual Report.
For
additional information with respect to certain of these and other factors, and
relating to the Company generally, reference is made to the Companys most
recent filings with the United States Securities and Exchange Commission
(available on EDGAR at www.sec.gov) and the filings made by the Company with
Canadian securities regulators (available on SEDAR at www.sedar.com). The forward-looking statements contained in
this document represent the Companys expectations as at March 31,
2008. Unless otherwise required by
applicable securities laws, the Company disclaims any intention or obligation
to update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Item 6.
Directors,
Senior Management and Employees
The following is a list of the current directors and senior officers of
the Company, their province or state of residence, their current position with
the Company and their principal business activities outside the Company:
Leslie L. Dan
|
|
Ontario,
Canada
|
|
Director
|
Director
since December 10, 1993.
|
|
|
|
|
Mr. Dan is Chairman of Novopharm Limited, one of Canadas leading
pharmaceutical companies and Chairman of Viventia Biotech Inc. Prior to April 5, 2000, Mr. Dan was
Chairman and Chief Executive Officer of Novopharm Limited. Until July 2007, he was also a member of
the Board of Directors of Teva Pharmaceutical Industries Limited (NASDAQ:
TEVA).
George
M. Darnell
|
|
Florida, United
States
|
|
Director
|
Director since
November 26, 1996.
|
|
|
|
|
Mr. Darnell is the retired President of the Dade Division and the
retired Executive Vice President of the Baxter Diagnostics Group of Baxter
International. He has over 35 years of
U.S. and international experience in the diagnostic industry.
Rolf H.
Henel
|
|
New Jersey,
United States
|
|
Director
|
Director since
August 14, 2002.
|
|
|
|
|
Mr. Henel is the retired President of
Cyanamid International, Lederle Division.
He currently serves as an advisor to the healthcare industry and is a
partner in Naimark & Associates, a healthcare consulting firm. He is also a director and Chairman of the
Compensation and Nominating and Corporate Governance Committees of SciClone
Pharmaceuticals, Inc. (NASDAQ: SCLN).
Brian
M. King*
|
|
Ontario, Canada
|
|
Chairman and
Director
|
Director since
May 26, 1994.
|
|
|
|
|
* Mr. Brian King will not seek
re-election as a director at our next annual shareholders meeting.
81
Mr. King is Chairman of the Board of Directors of the Company. He is the former Chairman and Chief Executive
Officer of Connaught Biosciences, Inc.
He is also a director and Chairman of the Compensation Committee of Onex
Corporation
(TSX: OCX)
and a director and member of the Investment,
Valuation and Audit Committees of VenGrowth Investment Funds.
Samuel
Sarick
|
|
Ontario, Canada
|
|
Director
|
Director since
March 31, 1989.
|
|
|
|
|
Mr. Sarick is President of Samuel Sarick Limited, a company with
long-standing involvement in commercial property development.
Bruce W.
Simpson
|
|
Texas, United States
|
|
Director
|
Director since
August 14, 2002.
|
|
|
|
|
Mr. Simpson
served as the President of the Genpharm division of E Merck, the President and
CEO of Medeva Pharmaceuticals in the United States and in senior management
positions at Fisons Corporation. He
currently heads a private consulting firm, B.W. Simpson & Associates,
specializing in marketing and business development within the healthcare
industry and is a director and member of the Compensation Committee of Hi-Tech
Pharmacal Co., Inc. (NASDAQ: HITK).
John A.
Vivash
|
|
Ontario, Canada
|
|
Director
|
Director since
November 17, 1998.
|
|
|
|
|
Mr. Vivash was formerly President and Chief Executive Officer of
CIBC Securities Inc., Fidelity Investments Canada Limited and Manulife
Securities International Ltd. He
currently serves as President and Chief Executive Officer of Tesseract
Financial Inc., a financial services consultancy, and director and Chairman of
the Governance and Nominating Committee of Cangene Corporation (TSX: CNJ). He is also Vice-Chair of the Ontario College
of Art and Design Foundation and a member of the Board of Directors, the Audit
Committee and the Conduct Review Committee of State Street Trust Company
Canada.
Mark
Oleksiw
|
|
Québec, Canada
|
|
Officer
|
Officer since
July 2003.
|
|
|
|
|
Mr. Oleksiw joined DRAXIS as Director of Finance in July 2002
after eight years with an international accounting firm, most recently as a
senior manager with a focus on U.S. and Canadian publicly listed life science
and technology companies. He also spent
three years with Bell Canada and BCE Inc. with responsibility for external
reporting, plus two years as a senior internal auditor at McGill University. Mr. Oleksiw is a Chartered Accountant
and earned his Graduate Diploma in Public Accountancy and B. Comm. from McGill
University. He became Chief Financial
Officer on July 1, 2003.
Dan Brazier
|
|
Ontario, Canada
|
|
Officer
|
Officer since
August 1998.
|
|
|
|
|
Mr. Brazier, Hon. B. Comm., joined DRAXIS in August 1998 as
President of SpectroPharm Dermatology, in October 2005, he was appointed
as Chief Operating Officer, and, since January 1, 2008, holds the position
of President and Chief Executive Officer.
Prior to July 1, 2003, Mr. Brazier served as President of
DRAXIS Pharmaceutica. Prior to joining
the Company, Mr. Brazier was the Director of Skin Care at Allergan
Inc. Mr. Brazier also held
positions in Marketing Management and Sales Management in his 10 years with
Allergan. From 1980-1989, Mr. Brazier
held Marketing and Sales positions with Bausch & Lomb, Stafford Foods
and Canada Packers. Mr. Brazier holds an Honors B. Comm., majoring in
Marketing and Finance.
82
Jean-Pierre
Robert
|
|
Québec, Canada
|
|
Officer
|
Officer since May 2005.
|
|
|
|
|
Mr. Robert, B.Sc., is Chief Operating Officer and President of
DRAXIS Specialty Pharmaceuticals Inc. Prior to joining DRAXIS, he served as
Vice President and General Manager of Tyco Healthcare (Canada), overseeing
domestic and export operations, following its acquisition of Mallinckrodt
(Canada), where he held the same position. Most recently, Mr. Robert was
President and CEO of an emerging Canadian biopharmaceutical company. He has
extensive healthcare industry experience including executive, general
management, marketing and sales roles involving diagnostic, pharmaceutical,
chemical and laboratory products with Mallinckrodt, Fisher Scientific, Hoechst
and Bayer. He holds a B.Sc. and was a member of the Canadian Society of Nuclear
Medicine.
Jerry
Ormiston
|
|
Ontario, Canada
|
|
Officer
|
Officer since May 2001.
|
|
|
|
|
Mr. Ormiston, B.Sc., MBA, joined DRAXIS in May 2001 as
Executive Director, Investor Relations following two years as a senior
consultant in a Toronto investor relations firm working with small and
mid-sized entrepreneurial companies on capital markets communications
strategies. Prior to that he was at
Allelix Biopharmaceuticals for 12 years four as Manager of Investor Relations
and eight in the business development area.
He has 32 years experience in the healthcare industry in
pharmaceuticals and biotechnology. His
assignments over those years have included positions in business development,
marketing, corporate communications, production management, quality assurance
and regulatory affairs.
Alida
Gualtieri
|
|
Québec, Canada
|
|
Officer
|
Officer since
November 2003.
|
|
|
|
|
Ms. Gualtieri joined the Company in November 2003 as General
Counsel and Secretary. Prior to joining
the Company, she was a partner in the Corporate Finance Mergers &
Acquisitions group of McCarthy Tétrault LLP in Montréal, Québec, one of
Canadas largest law firms. Between March 1996
and August 1999, Ms. Gualtieri was legal counsel at Fonds de
Solidarité des Travailleurs du Québec (F.T.Q.), Canadas largest
labor-sponsored venture capital fund. Ms. Gualtieri
earned her BCL and LLB law degrees at McGill University in 1987 and was
admitted to the Bar of the Province of Québec in 1988.
According to our By-laws, terms of office as director are for one year
or until the next Annual Meeting of the Shareholders and subsequent Meeting of
the Board of Directors, respectively.
There is no family relationship between any of the executive
officers. There is no arrangement or
understanding with any person pursuant to which any director or officer
referred to above was selected as a director or member of senior
management. Officers of the Company
serve at the pleasure of the Board of Directors.
Summary Compensation Table
The following table sets forth all compensation
for services in all capacities to the Company and its subsidiaries for the
fiscal years ended December 31, 2007, 2006, and 2005 in respect of each of
the individuals who were, at December 31, 2007, the Chief Executive
Officer, the Chief Financial Officer, and each of the Companys three most
highly compensated executive officers other than the CEO and CFO and who
received salary and bonus in excess of $150,000 in the 2007 fiscal year (the
Named Executive Officers).
83
|
|
|
|
Annual
Compensation
|
|
Long Term
Compensation
|
|
|
|
|
|
|
|
Salary
|
|
Bonus
|
|
Other
Annual
Compen-sation
(1)
|
|
Long Term
Compens-ation
Awards
|
|
LTIP
Payouts
|
|
All Other
Compen-sation
|
|
Name &
Principal Position
|
|
Year
|
|
Cash
(CDN$)
|
|
DSU
Election
(
2)
(CDN$)
|
|
Cash
(CDN$)
|
|
DSU
Election
(2)
(CDN$)
|
|
(CDN$)
|
|
Securities
Under
Options
Granted
(# of
common
shares)
|
|
(CDN$)
|
|
(CDN$)
|
|
Martin Barkin, MD (3)
|
|
2007
|
|
493,750
|
|
nil
|
|
nil
|
|
nil
|
|
22,889
|
(4)
|
50,000
|
|
nil
|
|
480,375
|
(5)
|
President & Chief
|
|
2006
|
|
468,750
|
|
nil
|
|
219,633
|
|
nil
|
|
25,053
|
|
50,000
|
|
nil
|
|
156,873
|
(6)
|
Executive Officer
|
|
2005
|
|
450,000
|
|
nil
|
|
91,432
|
|
nil
|
|
23,355
|
|
50,000
|
|
nil
|
|
1,611,000
|
(7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark Oleksiw
|
|
2007
|
|
268,750
|
|
nil
|
|
nil
|
|
nil
|
|
11,208
|
|
55,000
|
|
nil
|
|
33,259
|
(8)
|
Chief Financial
|
|
2006
|
|
232,500
|
|
nil
|
|
87,150
|
|
nil
|
|
12,391
|
|
25,000
|
|
nil
|
|
nil
|
|
Officer
|
|
2005
|
|
225,000
|
|
nil
|
|
37,587
|
|
nil
|
|
11,150
|
|
25,000
|
|
nil
|
|
nil
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dan Brazier(9)
|
|
2007
|
|
365,000
|
|
nil
|
|
nil
|
|
nil
|
|
14,994
|
|
55,000
|
|
nil
|
|
139,600
|
(10)
|
Chief Operating
|
|
2006
|
|
320,000
|
|
nil
|
|
122,957
|
|
100,000
|
(11)
|
15,694
|
|
25,000
|
|
nil
|
|
nil
|
|
Officer
|
|
2005
|
|
290,000
|
|
nil
|
|
48,333
|
|
nil
|
|
13,666
|
|
75,000
|
|
nil
|
|
61,475
|
(12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jean-Pierre Robert(13)
|
|
2007
|
|
341,042
|
|
nil
|
|
nil
|
|
nil
|
|
13,981
|
|
25,000
|
|
nil
|
|
29,999
|
(14)
|
President, DRAXIS
|
|
2006
|
|
296,250
|
|
nil
|
|
101,929
|
|
nil
|
|
10,409
|
|
25,000
|
|
nil
|
|
nil
|
|
Specialty
|
|
2005
|
(15)
|
183,606
|
|
nil
|
|
45,206
|
|
nil
|
|
594
|
|
100,000
|
|
nil
|
|
nil
|
|
Pharmaceuticals Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alida Gualtieri
|
|
2007
|
|
230,000
|
|
nil
|
|
nil
|
|
nil
|
|
9,586
|
|
45,000
|
|
nil
|
|
102,325
|
(16)
|
General Counsel &
|
|
2006
|
|
197,500
|
|
nil
|
|
56,080
|
|
nil
|
|
10,442
|
|
15,000
|
|
nil
|
|
nil
|
|
Secretary
|
|
2005
|
|
190,000
|
|
nil
|
|
18,236
|
|
6,079
|
|
9,627
|
|
15,000
|
|
nil
|
|
nil
|
|
(1)
Other Annual Compensation
includes payment of insurance premiums and a payment equal to 5% of the Named
Executive Officers base salary from the period of 2007 (for Registered
Retirement Savings Plan purposes in accordance with the terms of their
employment with the Company (the RRSP payment)). For the period of
January 1st, 2006 to April 30th, 2006, the RRSP payment was equal to
5% of the Named Executive Officers base salary. For the period from
May 1st, 2006 to December 31, 2006, the RRSP payment was equal to 4%
of the Named Executive Officers base salary. For the year 2005, the RRSP
payment equalled 5% of the Named Executive Officers base salary.
(2)
Amounts in these columns relate
to the portions of salary and bonus elected to be received in the form of
Deferred Share Units (DSUs) and are in addition to the cash amounts specified.
See Incentive Plans Deferred Share Unit Plan.
(3)
Effective December 31,
2007, Dr. Barkin resigned as President and Chief Executive Officer as well
as director of the Company. Dr. Barkin is employed as a Special Advisor to
the Board for the period from January 1, 2008 to January 9, 2009 at a
fixed salary for the term of the employment of CDN$250,000.
(4)
This includes club fees of
$2,025.
(5)
Dr. Barkin realized an
aggregate value of $480,375 from the exercise of 225,000 options in 2007. This
value is included in income for tax purposes.
(6)
Dr. Barkin realized an
aggregate value of $156,873 from the exercise of 130,125 options in 2006. This
value is included in income for tax purposes.
(7)
Dr. Barkin realized an
aggregate value of $1,291,000 from the exercise of 400,000 options in
2005. This value is included in income for tax purposes. In addition, $320,000
was paid by the Company in connection with his Retirement Compensation
Agreement.
(8)
Mr. Oleksiw realized an
aggregate value of $33,259 from the exercise of 13,333 options in 2007. This
value is included in income for tax purposes.
(9)
Mr. Brazier joined the
Company in August 1998 as President of SpectroPharm Dermatology. In
October 2005, he was appointed as Chief Operating Officer of the Company,
and on January 1, 2008, he was appointed President and Chief Executive
Officer.
(10)
Mr. Brazier realized an
aggregate value of $139,600 from the exercise of 35,000 options in 2007. This
value is included in income for tax purposes.
(11)
Mr. Brazier elected to
receive his 2005 special bonus of an amount of $100,000 in DSUs.
(12)
Mr. Brazier realized an
aggregate value of $61,475 from the exercise of 15,000 options in 2005. This
value is included in income for tax purposes.
(13)
On July 20, 2007, Mr. Robert
was appointed President of DRAXIS Specialty Pharmaceuticals Inc. On
January 1, 2008, Mr. Robert was appointed Chief Operating Officer of
the Company. He retained his title of President of DRAXIS Specialty
Pharmaceuticals Inc.
(14)
Mr. Robert realized an
aggregate value of $29,999 from the exercise of 16,666 options in 2007. This
value is included in income for tax purposes.
(15)
Mr. Robert joined the
Company as President of DRAXIMAGE, a division of DRAXIS Specialty
Pharmaceuticals Inc., on May 9, 2005.
(16)
Ms. Gualtieri realized an
aggregate value of $102,325 from the exercise of 25,000 options in 2007. This
value is included in income for tax purposes.
84
Incentive Plans
Philosophy
The Companys philosophy is to link employee compensation to the success
of the Company and to emphasize at risk employee compensation.
The Company has implemented the following plans in an effort to achieve
at risk employee compensation: Stock Option Plan, Deferred Share Unit Plan,
Employee Group Registered Retirement Savings Plan and Non-Executive Long Term
Incentive Plan. The Company does not
provide any form of pension retirement or similar benefits. The Company does not set aside, accrue or
determine the amount of its costs that is attributable to senior management.
2006
Stock Option Plan
Intention and Participant
-
This plan was approved by the shareholders of the Company on May 18,
2006 and the shareholders approved certain amendments to this plan on May 17,
2007 to assist and encourage directors, officers and employees of the Company
and its subsidiaries to work towards and participate in the growth and
development of the Company and its subsidiaries by providing such persons with
the opportunity, through stock options, to acquire an ownership interest in the
Company. A copy of the amended plan is
filed as Exhibit 4.63
to this Annual Report (Form 20-F).
Maximum Common Shares
Issuable
- The
shareholders authorized, at the Companys annual meeting on May 18, 2006,
the issuance of up to 1,500,000 common shares under this plan. As at March 18, 2008, 655,000 options
have been granted and are outstanding under this plan, representing 1.6% of the
Companys issued and outstanding common shares as at March 18, 2008. As at March 18, 2008, 845,000 common
shares remain reserved for further option grants, representing 2.0% of the
Companys issued and outstanding common shares as at such date. The maximum number of common shares that may
be reserved for issuance to insiders pursuant to options granted under the plan
and any other share compensation arrangement is 10% of the number of common
shares outstanding and the maximum number of common shares that may be issued
to insiders within one year period is 10% of the number of common shares
outstanding. The number of shares
reserved for issuance to any one person, including insiders, pursuant to
options granted in accordance with the plan or otherwise cannot exceed 5% of the
outstanding common shares of the Company.
Determination of Number, Price and Term of
Options - The Board of Directors determines the price per common share, the
number of options for common shares which may be allotted to each designated
director, officer or employee, the period in which any option may be exercised
and all the terms and conditions of the option in accordance with the
applicable requirements of any regulatory authority or stock exchange.
The exercise price of common shares subject to an
option will be determined by the Board at the time of grant and will not be
less than the market price of the common shares at the Grant Date, calculated
as the closing price of a board lot of the common shares on The Toronto Stock
Exchange on the last trading day immediately preceding the Grant Date or, if
the common shares did not trade on such last trading day, the average, rounded
up to the nearest cent, of the bid and ask prices for a board lot of the common
shares at the close of trading on such last trading day.
Dilution Guideline - The
Company has an established guideline limiting the aggregate number of common
shares that can be issued at any point in time through the exercise of options
to 13% of the
85
Companys
outstanding common shares.
As at March 18,
2008, the number of common shares so issuable under the 2006 Stock Option Plan
and the Stock Option Plan of DRAXIS Health Inc. represented 5.1% of the
Companys outstanding common shares.
Vesting - The period
during which any option may be exercised is determined by the Board of
Directors at the time at which the option is granted and shall be no later than
ten years from the grant date.
Assignability -
Options are non-assignable and non-transferable.
Termination
of Employment, Permanent Disability or Death of an Option Holder If an option
holder ceases to hold office as a director, officer or employee of the Company
during an option period, the exercisable options may be exercised for a period
of thirty days after such option holder ceases to hold such office or position
or for a longer period as the Board of Directors may approve. In the event of the total and permanent
disability of an option holder, the exercisable options may be exercised for a
period of six months after the date on which the Board of Directors has
determined that the option holder is permanently disabled or for such longer
period as the Board of Directors may approve.
In the event of the death of an option holder, the options that were
exercisable at the date of the death may be exercised by the option holders
executors or personal representatives within six months of the option holders
death or for such longer period as the Board of Directors may approve.
Amendment of plan - Except
as set forth below, the Board of Directors may amend, suspend or terminate the
2006 Stock Option Plan at any time in accordance with applicable legislation
without obtaining the approval of the shareholders. Any amendment to any provision of the Plan
will be subject to any required regulatory or shareholder approval. The Company is required to obtain the
approval of the shareholders of the Company for any amendment in relation to: (i) the
maximum number of shares reserved for issuance under the Plan (and under any
other share compensation arrangements of the Company); (ii) a reduction in
the exercise price for options; (iii) an extension to the term of options
held; (iv) the increase in the 10% limits on grants to insider set out in Section 3.04(1) of
the Plan and any shareholder approval required in respect of an amendment to
increase such limits shall exclude the votes attaching to the common shares, if
any, held by optionholders who are insiders.
Grant of Options - In 2007,
420,000 options were awarded under the 2006 Stock Option Plan. Between January 1, 2008 and March 18,
2008, 260,000 options were awarded under the 2006 Stock Option Plan.
Stock
Option Plan of DRAXIS Health Inc.
Options Available for
Future Grants
- No additional options are available for
issuance under this plan since the 2006 Stock Option Plan was adopted on May 18,
2006.
Intention and Participants
- This plan was approved by shareholders on February 3, 1988 and amended
on June 27, 2001 to permit the Board of Directors to grant options to
purchase common shares to directors, officers, employees and arms length
consultants of the Company and its subsidiaries so as to link corporate
compensation to enhanced shareholder value.
Amendments to this plan were
approved by the shareholders of the Company on May 17, 2007. A copy of the amended plan is filed as Exhibit 4.64
to this Annual Report (Form 20-F).
Maximum Common Shares
Issuable - In 2001, the shareholders authorized, at the Companys annual and
special meeting, the issuance of up to 7,500,000 common shares under this
plan. As at March 18, 2008,
1,470,828 options have been granted and are outstanding under this plan and the
same number of shares remain reserved for issuance, representing 3.5% of the
Companys issued and
86
outstanding common shares as at that
date. The number of shares reserved for
issuance to any one person, including insiders, pursuant to options granted in
accordance with the plan or otherwise cannot exceed 5% of the outstanding common
shares of the Company. No additional
options are available for granting under this Plan since the 2006 Stock Option
Plan was adopted on May 18, 2006.
Determination of Number,
Price and Term of Options - The Board of Directors determined the price per
common share, the number of options for common shares which may be allotted to
each designated director, officer, employee or arms length consultant, the
period in which any option could be exercised and all the terms and conditions
of the option in accordance with the applicable requirements of any regulatory
authority or stock exchange. No
additional options are available for granting under this Plan since the 2006
Stock Option Plan was adopted on May 18, 2006.
Dilution Guideline - The
Company established a guideline limiting the aggregate number of common shares
that can be issued at any point in time through the exercise of options to 13%
of the Companys outstanding common shares. As at March 18, 2008, the
number of common shares so issuable was 3.5% of the Companys outstanding
common shares.
Vesting - The period during
which any option could be exercised was determined by the Board of Directors at
the time at which the option was granted and is no later than ten years from
the grant date.
Assignability - Options are
non-assignable and non-transferable.
Termination of Employment,
Permanent Disability or Death of an Option Holder If an option holder ceases
to hold office as a director, officer or employee of the Company during an
option period, the exercisable options may be exercised for a period of thirty
days after such option holder ceases to hold such office or position or for a
longer period as the Board of Directors
may approve. In the event of the total
and permanent disability of an option holder, the exercisable options may be
exercised for a period of six months after the date on which the Board of
Directors has determined that the option holder is permanently disabled or for
such longer period as the Board of Directors may approve. In the event of the
death of an option holder, the options that were exercisable at the date of the
death may be exercised by the option holders executors or personal
representatives within six months of the option holders death.
Amendment of Plan - Except
as set forth below, the Board of Directors may amend, suspend or terminate the
Stock Option Plan of DRAXIS Health Inc. at any time, in accordance with
applicable legislation without obtaining the approval of the shareholders. Any amendment to any provision of the Plan
will be subject to any required regulatory or shareholder approval. The Company is required to obtain the
approval of the shareholders of the Company for any amendment in relation to: (i) the
maximum number of shares reserved for issuance under the Plan (and under any
other share compensation arrangements of the Company); (ii) a reduction in
the exercise price for options; and (iii) an extension to the term of
options.
Aggregate Option Grants to
Named Executive Officers
- As of May 18, 2006, no options have been awarded under this Plan and no
further options shall be awarded under this Plan.
87
The following table sets forth all of the options of the Company granted
during the financial year ended December 31, 2007:
Name
|
|
Securities
Under
Options Granted
(#)
(1)
|
|
% of
Total
Options Granted
to
Employees in Financial Year
|
|
Exercise
or Base
Price
(CDN$/Security)
(2)
|
|
Market
Value of Securities Underlying Options on the Date of Grant (CDN$/Security)
|
|
Expiration Date
|
Martin Barkin,
MD President & Chief Executive Officer(3)
|
|
50,000
|
|
11.9
|
|
CDN $5.62
|
|
CDN $5.62
|
|
December 31,
2011
|
Mark Oleksiw
Chief Financial Officer
|
|
25,000
30,000
|
|
13.1
|
|
CDN $5.62
CDN $5.93
|
|
CDN $5.62
CDN $5.93
|
|
December 31,
2011 February 11, 2012
|
Dan Brazier
Chief Operating Officer(3)
|
|
25,000
30,000
|
|
13.1
|
|
CDN $5.62
CDN $5.93
|
|
CDN $5.62
CDN $5.93
|
|
December 31,
2011 February 11, 2012
|
Jean-Pierre
Robert President, DSPI(3)
|
|
25,000
|
|
6.0
|
|
CDN $5.62
|
|
CDN $5.62
|
|
December 31,
2011
|
Alida Gualtieri
General Counsel & Secretary
|
|
15,000
30,000
|
|
10.7
|
|
CDN $5.62
CDN $5.93
|
|
CDN $5.62
CDN $5.93
|
|
December 31,
2011 February 11, 2012
|
(1)
All of the above options have a three year vesting period with
one-third of the options vesting in each of the three years from the date of
grant. All options were granted in accordance with the 2006 Stock Option
Plan. The Board allowed Dr. Barkin
to keep all issued and outstanding options as at December 31, 2007 to
their normal date of maturity and in accordance with their vesting schedule as
set forth in the option grants of said options.
(2)
The Exercise Price of the options was determined by the Board of
Directors in accordance with the provisions of the 2006 Stock Option Plan.
(3)
On October 31, 2007, the Company announced
that Dr. Barkin was resigning as President and CEO of the Company
effective December 31, 2007. On January 8,
2008, the Company announced that Mr. Dan Brazier was appointed President
and CEO and Mr. Jean-Pierre Robert was appointed Chief Operating Officer
of the Company effective January 1, 2008.
The following table sets forth individual exercises of options by the
Named Executive Officers during the financial year ended December 31, 2007
and the financial year-end value of unexercised options:
Name
|
|
Securities
Acquired on
Exercise
|
|
Aggregate Value
(CDN$) Realized
|
|
Unexercised Options at
December 31, 2007
(#)
Exercisable/
Unexercisable
|
|
Value of Unexercised in-the-Money Options at December 31, 2007
(CDN$)
Exercisable/
Unexercisable
|
|
Martin Barkin,
MD
President & Chief
Executive Officer*
|
|
225,000
|
|
480,375
|
|
100,000 / 50,000
|
|
nil / nil
|
|
Mark Oleksiw
Chief Financial Officer
|
|
13,333
|
|
33,259
|
|
50,000 / 155,000
|
|
nil / 171,000
|
|
Dan Brazier
Chief Operating Officer
|
|
35,000
|
|
139,600
|
|
150,000 /
205,000
|
|
nil / 171,000
|
|
Jean-Pierre
Robert
President,
DRAXIMAGE division
|
|
16,666
|
|
29,999
|
|
25,001 / 108,333
|
|
nil / nil
|
|
Alida Gualtieri
General Counsel &
Secretary
|
|
25,000
|
|
102,325
|
|
30,000 / 45,000
|
|
nil / nil
|
|
*
On October 31,
2007, the Company announced that Dr. Barkin was resigning as President and
CEO of the Company effective December 31, 2007. On January 8, 2008, the Company
announced that Mr. Dan Brazier was appointed President and CEO and that Mr. Jean-Pierre
Robert was appointed Chief Operating Officer of the Company effective January 1,
2008.
88
Deferred Share
Unit Plan
Intention -
This Plan was adopted in January 2000 and, in December 2007,
the Board of Directors approved certain amendments to this Plan to further
align the interests of senior management with those of shareholders by
increasing management shareholdings at minimal cost to the Company. The
amendments were of an administrative nature and to clarify the application of
the Plan in accordance with Interpretation Bulletin IT-337R4 of Revenue Canada.
A copy of
the amended Deferred Share Unit Plan is filed as Exhibit 4.65.
Mechanism - Eligible participants in this plan are entitled to elect
yearly to receive up to 20% of base salary and up to 100% of any bonus payable
in respect of that year in Deferred Share Units in lieu of cash
compensation. An election must be made
by December 1 of each year in respect of base salary and bonus for the
next year. The elected amount is converted
to a number of Deferred Share Units equal to the elected amount divided by the
closing price of the common shares on the Toronto Stock Exchange or The NASDAQ
National Market System on December 31 of each year, based on a purchase
commitment as of December 1 of the prior year. This plan is administered by the Board of
Directors of the Company.
Participants - Members of senior management of the Company designated by
the Human Resources and Compensation Committee.
Redemption of Deferred Share Units -
Participants are not entitled to receive
any Deferred Share Units until cessation of employment with the Company for any
reason or their death (the Redemption Date).
The redemption value of each Deferred Share Unit, redeemable by the
participant, is the average of the daily high and low board lot trading prices
of the common shares of the Company on the Toronto Stock Exchange or NASDAQ
Stock Exchange on each of the five trading days prior to the Redemption
Date. The Deferred Share Units must be
redeemed no later than the end of the first calendar year commencing after the
Redemption Date.
Named Executive Officer Elections for 2005, 2006, 2007 and 2008 - The
following table summarizes the elections under this Plan by Named Executive
Officers for the last four fiscal year of the Company:
|
|
Deferred
Share Unit Elections
|
|
|
|
2005
|
|
2006
|
|
2007
|
|
2008
|
|
|
|
Salary
|
|
Bonus
|
|
Salary
|
|
Bonus
|
|
Salary
|
|
Bonus
|
|
Salary
|
|
Bonus
|
|
|
|
%
|
|
$
|
|
%
|
|
$
(CDN)
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
Martin Barkin(1)
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
Dan Brazier(2)
|
|
nil
|
|
nil
|
|
67
|
|
100,000
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
Alida Gualtieri(3)
|
|
nil
|
|
nil
|
|
25
|
|
6,079
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
Jean-Pierre Robert
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
Mark Oleksiw
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
nil
|
|
(1)
As at
March 18, 2008, Dr. Barkin had a total of 186,560 Deferred Share Units and the value of his
interest in this plan at said date was CDN$891,757.
(2)
As at
March 18, 2008, Mr. Brazier had a total of 19,802 Deferred Share Units and the value of his
interest in this plan at said date was CDN$94,654.
89
(3)
As at March 18,
2008, Ms. Gualtieri had a total of 1,020 Deferred Share Units and the value of her
interest in this plan at said date was CDN$4,876.
Employee
Group Registered Retirement Savings Plan
Intention To
provide a cost-sharing program for employees of the Company and its
subsidiaries by way of a corporate sponsored registered retirement savings plan
(RRSP) matching mechanism for employee retirement.
Mechanism
Commencing 12 months after continuous employment, employees of the Company and
its subsidiaries are entitled to receive a discretionary payment from the
Company which matches employee contributions on a dollar-for-dollar basis
towards an employees RRSP, up to a maximum of 5% of the employees eligible
income (normal straight time annual earnings or salary, not to include
overtime payments, bonus or any other form of exceptional payment). The corporate contribution to this plan
remains under the ownership and control of the employee and is not subject to
any lock-in provisions. The plan is
administered by a committee composed of employees and management. Subject to the investment choices approved by
the committee, employees control the investment of the contributions of both
the employees and the Company.
Participants
Participation is open to all full and part-time permanent Canadian employees of
the Company and its subsidiaries, other than designated senior management
employees and the Named Executive Officers.
Commencement Date
The plan commenced on January 1, 2002, but employee matching
contributions were not required until 2006.
In 2006 and 2007, matching contributions were required.
Non-Executive
Long Term Incentive Plan
Intention - This
plan was approved by the Board of Directors on December 6, 2005. Its purposes are: (i) to align the
interests of eligible employees with the interests of the shareholders of the
Company; (ii) to attract and retain key employees; and (iii) to
ensure that key employees incentives and rewards are consistent with the
strategic business initiatives of the Company and to achieve divisional and
corporate financial goals to enhance shareholder value.
Mechanism The
maximum plan award for any two-year cycle is established by the Board of
Directors at the beginning of each cycle and is a percentage of a participants
average annual base salary for the cycle.
A portion of the maximum plan award is determined based on the Companys
cumulative earnings per share (EPS) target for the cycle (Financial Portion)
and a portion of the maximum plan award is determined based on the performance
of the individual participant during the cycle (Performance Portion). The maximum percentage of the plan award
comprised of the Financial Portion and the maximum percentage of the plan award
comprised of the Performance Portion are identical for all participants within
each cycle and are established by the Board of Directors. The portion of the maximum potential
Financial Portion and the maximum potential Performance Portion that a
participant will be awarded depends upon the EPS achieved during the cycle and
whether the participant has achieved his or her performance objectives,
respectively. The plan is administered
by the President and Chief Executive Officer of the Company under the
supervision of the Board of Directors.
All plan awards are paid in cash within 90 days of the end of a
cycle. The first two-year cycle for this
plan terminated on December 31, 2007.
There were no payments made in accordance with this plan for said cycle.
Participants Members
of senior management of the Company who are full time employees may be selected
to participate in the plan. Members of
the Executive Committee and those senior managers of the Company who
participate in an established incentive or participation plan of the Company
are
90
excluded from participating in this plan. None of the Named Executive Officers may
participate in the plan.
Subsidiary Long-Term Incentive Plans
DRAXIMAGE, a
division of DRAXIS Specialty Pharmaceuticals Inc.
Intention To align further the interests of senior management in
DRAXIMAGE (formerly DRAXIMAGE Inc.), a division of DRAXIS Specialty
Pharmaceuticals Inc. (DRAXIMAGE), for increasing the value of the division
and therefore enhancing shareholder value of the Company as a whole.
Mechanism The terms of this plan provide that, subject to the
achievement of certain conditions, the Company will make payments to plan
participants in the form of cash based on the increase in the fair market value
of DRAXIMAGE as of the date of the onset of the Plan and the date of
termination of the Plan.
Participants Selected members of senior management of DRAXIMAGE as
designated by the Company. Mr. Jean-Pierre
Robert participates in this plan but received no award under the plan in 2007.
DRAXIS Pharma,
a division of DRAXIS Specialty Pharmaceuticals Inc.
Intention
In September 2003, the
then-existing Equity Participation Plan of DRAXIS Pharma Inc. (as of January 1,
2005 known as DRAXIS Pharma, a division of DRAXIS Specialty Pharmaceuticals
Inc.) was terminated and replaced with a Long Term Equity Incentive Plan to
provide certain senior management employees of DRAXIS Pharma with a meaningful
incentive to increase the value of the Company and to allow management to share
in the benefits of that value creation.
Mechanism
The terms of this plan provide that eligible participants
have a right to receive the cash value of phantom equity shares of DRAXIS
Pharma on the plan expiry date or other designated termination event. In order for an eligible participant to
receive a termination distribution amount with respect to this plan, certain
financial ratios must be met by DRAXIS Pharma.
Participants Selected members of senior management of DRAXIS Pharma as
designated by the Company. The Company
made no payments under this plan to the Named Executive Officers in 2007 but
payments were made in 2007 to two participants who are not Named Executive
Officers.
Compensation of Directors
The compensation of the Board of Directors has not changed since January 1,
2005 at which time the Company used a third-party survey related to Board
compensation in Canada to determine what payments should be made to the Board
of Directors. Directors who are employees
of the Company do not receive any compensation in their capacity as directors.
During the 2007 year, each director, other than Dr. Martin Barkin* and
the Chairman, received an annual honorarium of CDN$17,500 plus a meeting fee of
CDN$1,500 for each Board of Directors and Committee meeting attended, including
the meetings attended via teleconference.
Related travel and out-of-pocket expenses to attend Board and Committee
meetings were also reimbursed to each director.
The members of the Special Committee created in May 2006 received
compensation of CDN$1,500 for each meeting they attended, including the
meetings attended via teleconference and each received a retainer fee of
CDN$10,000 (CDN$15,000 for the
|
|
* Dr. Martin Barkin resigned as a director
effective December 31, 2007.
|
91
Chairman).
In addition, the Chairs of each of the Human Resources and Compensation
Committee and the Nominating and Corporate Governance Committee received an
annual retainer of CDN$5,000. The
Chairman of the Audit Committee received an annual retainer of CDN$10,000. For the year ended December 31, 2007, in
addition to the retainer of CDN$5,000 received as Chairman of the Human
Resources and Compensation Committee, Mr. Brian King received CDN$95,000
as non-executive Chairman of the Board of Directors, CDN$15,000 as the Chairman
for the Special Committee and CDN$12,000 for attending meetings of the Special
Committee. He did not otherwise receive
meeting fees as a director.
The following table sets forth the total compensation paid in Canadian
dollars to each director in the year ended December 31, 2007. Martin Barkin, as an employee of the Company,
did not receive any compensation in his capacity as a director.
|
|
Leslie Dan
|
|
George
Darnell (1,2)
|
|
Rolf Henel (1,2)
|
|
Brian King (3,4,5)
|
|
Sam Sarick (1,4)
|
|
Bruce
Simpson
(1,3,4)
|
|
John Vivash (2,3,4)
|
|
Annual
Retainer
|
|
$ 17,500
|
|
$17,500
|
|
$17,500
|
|
$95,000
|
|
$17,500
|
|
$17,500
|
|
$17,500
|
|
Chairman
Retainer
|
|
|
|
|
|
|
|
$5,000
|
|
$10,000
|
|
|
|
$5,000
|
|
Committee
Retainer
|
|
|
|
$5,000
|
|
$5,000
|
|
$15,000
|
|
$15,000
|
|
$7,500
|
|
$10,000
|
|
Committee
meetings
|
|
|
|
$15,00
|
|
$15,000
|
|
$12,000
|
|
$16,500
|
|
$24,000
|
|
$30,000
|
|
Board
meetings
|
|
$ 16,500
|
|
$16,500
|
|
$16,500
|
|
|
|
$16,500
|
|
$18,000
|
|
$18,000
|
|
TOTAL
|
|
$ 34,000
|
|
$54,000
|
|
$54,000
|
|
$127,000
|
|
$75,500
|
|
$67,000
|
|
$80,500
|
|
Options
|
|
15,000
|
|
15,000
|
|
15,000
|
|
20,000
|
|
15,000
|
|
15,000
|
|
15,000
|
|
(1)
|
|
Member of the
Audit Committee.
|
(2)
|
|
Member of the
Nominating and Corporate Governance Committee.
|
(3)
|
|
Member of the
Human Resources and Compensation Committee.
|
(4)
|
|
Member of the
Special Committee created in May 2006. Mr. Bruce Simpson became a
member of this Committee on October 31, 2007.
|
(5)
|
|
Mr. Brian
King will not be seeking re-election as a director and a substitute member
will have to be elected for each Committee in which he participated.
|
Each of the directors (excluding the President and
Chief Executive Officer) is awarded 15,000 options as partial compensation for
services rendered as directors each January 1
st
. The Chairman is awarded an additional 5,000
options. All options are granted at the
closing price of the common shares on the TSX for the trading day immediately
preceding their grant date.
From time to time, special committees of the Board of Directors, such as
the Special Committee constituted in May 2006, are appointed to consider
special issues. Compensation for work on
such committees is set based on the amount of work involved.
Minimum Shareholding Requirements
In June 2001, the Board of
Directors established a corporate policy requiring each then current Director
to acquire by June 2004 (or in the case of future Board of Directors
members, within three years of their appointment) common shares in the Company
equal to five times his or her annual honorarium. All directors who were to comply with this
requirement by June 2004 were in compliance as of said date. In February 2005, the Board of Directors
adopted a resolution amending this policy to fix the number of common shares to
be so held at 15,000. Compliance with
this policy is monitored annually by the Nominating and Corporate Governance
Committee. As at December 31, 2007
and March 18, 2008, all directors were compliant with this policy.
92
Director shareholdings as of
March 18
, 2008
Director
|
|
Shares Owned
|
|
% Owned of total issued and
|
|
|
|
|
|
outstanding common shares
|
|
Leslie Dan
|
|
104,056
|
|
< 1
|
|
George Darnell
|
|
80,475
|
|
< 1
|
|
Rolf H. Henel
|
|
36,000
|
|
< 1
|
|
Brian King*
|
|
165,750
|
|
< 1
|
|
Sam Sarick
|
|
836,124
|
|
2.0
|
|
Bruce W. Simpson
|
|
40,000
|
|
< 1
|
|
John Vivash
|
|
25,000
|
|
< 1
|
|
Total
|
|
1,287,405
|
|
3.1
|
|
* Mr. Brian
King will not seek re-election as a director at our next annual shareholders
meeting.
Senior Management
shareholdings as of March 18, 2008
Senior Management
|
|
Shares Owned
|
|
% Owned of total issued and
|
|
|
|
|
|
outstanding common shares
|
|
Dan Brazier
(1)
|
|
9,355
|
|
<
1
|
|
Jean-Pierre Robert
|
|
0
|
|
nil
|
|
Alida Gualtieri
(2)
|
|
500
|
|
< 1
|
|
Chien Huang
(3)
|
|
0
|
|
nil
|
|
Mark Oleksiw
|
|
3,000
|
|
< 1
|
|
Jerry Ormiston
(4)
|
|
29,100
|
|
< 1
|
|
Total
|
|
41,955
|
|
< 1
|
|
(1)
In addition, as at March 18, 2008, Mr. Brazier
owns 19,802 Deferred Share Units and the value of his interest in this plan at
said date was CDN$94,654.
(2)
In addition, as at March 18, 2008, Ms. Gualtieri
owns 1,020 Deferred Share Units and the value of her interest in this plan at
said date was CDN$4,876.
(3)
In addition, as at March 18, 2008, Mr. Huang
owns 16,249 Deferred Share Units and the value of his interest in this plan at
said date was CDN$77,670.
(4)
In addition, as at March 18, 2008, Mr. Ormiston
owns 6,387 Deferred Share Units and the value of his interest in this plan at
said date was CDN$30,530.
93
Director outstanding options as of March
18
, 2008
Director
|
|
# of Options for
|
|
Exercise Price
|
|
Expiration Date
|
|
|
|
common shares
|
|
|
|
|
|
Leslie L. Dan
|
|
15,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
George M.
Darnell
|
|
15,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Rolf H. Henel
|
|
15,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Brian M. King*
|
|
20,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
20
,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
20,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
20,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
20,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Samuel Sarick
|
|
15,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Bruce W. Simpson
|
|
15,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
John A. Vivash
|
|
15,000
|
|
CDN$4.30
|
|
December 31,
2008
|
|
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Total
|
|
550,000
|
|
|
|
|
|
* Mr. Brian
King will not seek re-election as a director at our next annual shareholders
meeting.
94
Senior Management
outstanding options as of March
18
,
2008
Senior Management
|
|
# of Options for
|
|
Exercise Price
|
|
Expiration Date
|
|
|
|
common shares
|
|
|
|
|
|
Dan Brazier
|
|
100,000
|
|
CDN$2.36
|
|
July 14,
2013
|
|
|
|
100,000
|
|
CDN$4.70
|
|
August 10,
2009
|
|
|
|
25
,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
50,000
|
|
CND$5.38
|
|
October 2,
2015
|
|
|
|
25,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
25,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
30,000
|
|
CDN$5.93
|
|
February 11,
2012
|
|
|
|
50,000
|
|
CDN$4.07
|
|
December 31, 2012
|
|
Jean-Pierre Robert
|
|
16,667
|
|
CDN$6.05
|
|
May 10,
2010
|
|
|
|
75,000
|
|
CDN$6.05
|
|
May 10,
2015
|
|
|
|
16,667
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
25,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
35,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Alida Gualtieri
|
|
15
,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
30,000
|
|
CDN$5.93
|
|
February 11,
2012
|
|
|
|
25,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Chien Huang
|
|
50,000
|
|
CDN$2.36
|
|
July 14,
2013
|
|
|
|
15
,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
Mark Oleksiw
|
|
100,000
|
|
CDN$2.36
|
|
July 14,
2013
|
|
|
|
25
,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
25,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
25,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
30,000
|
|
CDN$5.93
|
|
February 11,
2012
|
|
|
|
25,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Jerry Ormiston
|
|
15,000
|
|
CDN$5.73
|
|
December 31,
2009
|
|
|
|
15,000
|
|
CDN$5.05
|
|
December 31,
2010
|
|
|
|
15,000
|
|
CDN$5.62
|
|
December 31,
2011
|
|
|
|
15,000
|
|
CDN$4.07
|
|
December 31,
2012
|
|
Total
|
|
1,058,334
|
|
|
|
|
|
Board Practices
Statement of Corporate Governance Practices
The Board of Directors of the Company believes that sound corporate
governance practices are essential to the well-being of the Company and its
shareholders, and that these practices should be reviewed regularly to ensure
that they are appropriate.
Effective June 30, 2005, National Instrument 58-101
Disclosure of Corporate Governance Practices
(NI 58-101) and National Policy 58-201
Corporate
Governance Guidelines
(NP 58-201) were adopted in
Canada. NI 58-101 requires issuers
to disclose the corporate governance practices that they have adopted. NP 58-201 provides guidance on corporate
governance practices. In addition, the
Company is subject to Multilateral Instrument 52-110
Audit Committees
(MI 52-110), which has been adopted
in various Canadian provinces and territories and which prescribes certain
requirements in relation to audit committees.
The Board of
Directors has
95
carefully considered and reviewed the series of
guidelines for effective corporate governance in NP 58-201, the corporate
governance requirements of the U.S.
Sarbanes-Oxley
Act of 2002
(the SOX Requirements), and the corporate governance
reforms of The NASDAQ Stock Market, Inc. (the NASDAQ Rules). The Board of Directors believes that the
Companys corporate governance practices satisfy the recommendations and rules contained
in these various regulations. The
Companys policies and practices for corporate governance are set out below.
Mandate
of the Board of Directors
The mandate of the Board of Directors is to
supervise the management of the business and affairs of the Company. In light of that responsibility, the Board of
Directors reviews, discusses and approves various matters related to the
Companys operations, strategic direction and organizational structure, where
required, and involves itself jointly with management in ensuring the creation
of shareholder value and in serving the best interests of the Company. In April 2004, the Board of Directors
adopted a detailed Charter. The Charter
is available on the Companys website at
www.draxis.com
. The Charter specifies that the Board of
Directors is responsible for:
(i)
|
|
Adopting a strategic planning
process for the Company;
|
|
|
|
(ii)
|
|
Adopting a
communications policy for the Company;
|
|
|
|
(iii)
|
|
Overseeing the
financial integrity of the Company;
|
|
|
|
(iv)
|
|
Monitoring compliance
with the corporate objectives of the Company;
|
|
|
|
(v)
|
|
Approving and
ascertaining that the Company monitors adherence to its Code of Ethics and
Business Conduct;
|
|
|
|
(vi)
|
|
Appointing the Chief
Executive Officer (the CEO), monitoring his performance and ascertaining
that succession plans are in place with respect to the CEO and senior
management;
|
|
|
|
(vii)
|
|
Ensuring that
appropriate structures and procedures are in place so that the Board of
Directors can function independently from management;
|
|
|
|
(viii)
|
|
Establishing
performance measures for the Company and its management;
|
|
|
|
(ix)
|
|
Monitoring compliance
with legal requirements and ascertaining that the Company has procedures
concerning the proper preparation, approval and maintenance of documents and
records;
|
|
|
|
(x)
|
|
Approving changes in
the By-laws and Articles of Incorporation and agendas for shareholder
meetings;
|
|
|
|
(xi)
|
|
Approving the Companys
legal structure, name and logo; and
|
|
|
|
(xii)
|
|
Performing such
functions as it reserves to itself or which cannot, by law, be delegated to
Committees of the Board of Directors or to management.
|
There are no service contracts with the Board members that provide for
any benefits upon their termination as directors of the Company.
There are five regularly scheduled Board of Directors meetings per
year. However, the Board of Directors
also meets as frequently as the need arises to consider major issues and
opportunities.
There were twelve meetings of the Board of Directors in 2007.
96
Position Descriptions
In April 2004,
the Company adopted terms of reference for each of the Non Executive Chair of
the Board of Directors (the Chair of the Board), the Committee Chairs and the
CEO setting out the key responsibilities of each of these individuals. The terms of reference for each of the CEO
and Chair of the Board of Directors were modified and adopted by the Board on May 17,
2007.
The
terms of reference for each of the Chair of the Board and the Committee Chairs
provide that each of these individuals is to be an independent director, has
unfettered two-way communication with all senior officers and reports to and
maintains open communication with the CEO.
In addition, the terms of reference also provide that the Chair of the Audit
Committee has unfettered two-way communication with the independent auditors of
the Company. The primary role of the
Chair of the Board and of the Committee Chairs includes ensuring that the Board
of Directors or the relevant Committee, as the case may be, functions properly,
that it meets its obligations and responsibilities, and that its organization
and mechanisms are in place and are working effectively. A copy of the
amended terms of reference of the Non Executive Chair is filed as Exhibit 4.66. The terms of reference of the Committee
Chairs were filed on SEDAR (www.sedar.com) on March 30, 2007.
The
terms of reference for the CEO provide that the CEO reports to and maintains
open communication with the Chair of the Board.
The terms of reference for the CEO provide that the CEO is to provide
overall leadership and vision in developing, in concert with the Board of
Directors, the strategic direction of the Company, and in developing the
strategies and business plans necessary to realise corporate objectives. They also provide that it is the CEOs
responsibility to manage the overall business of the Company to ensure
strategic and business plans are effectively implemented, the results are
monitored and reported to the Board of Directors, and financial and operational
objectives are attained. A copy of the
amended terms of reference for the CEO is filed as Exhibit 4.67 to
this Annual Report (Form 20-F).
Composition of the Board of
Directors
The Board of Directors has reviewed its composition to determine which
of the nominee directors may be considered independent in conformity with
applicable Canadian, TSX, U.S. and NASDAQ requirements. Generally, a director who does not have any
direct or indirect material relationship with the Company is considered
independent. A material relationship
is a relationship which could, in the view of the Board of Directors, be
reasonably expected to interfere with the exercise of a members independent
judgment.
The
Board of Directors, to be composed of seven members, has considered the
relationship of each of the nominee directors and has determined that five of
the seven nominee directors are considered to be independent. Messrs. Darnell, Henel, Sarick, Simpson
and Vivash are considered to be independent directors. Mr. Brazier is not considered to be an
independent director because he is the President and Chief Executive Officer of
the Company. Mr. Dan is not considered to be an independent director
because he was an executive officer of Viventia Biotech Inc. at a time when Dr. Martin
Barkin, former President and CEO and Director of the Company, was a member of
the Compensation Committee of that company.
Dr. Barkin was a director of the Company from May 19, 1992
until December 31, 2007. In
accordance with the provisions of Multilateral Instrument 52-110, Mr. Dan
will be deemed to be a non-independent director until December 30, 2008.
The Board of Directors believes that during his tenure Dr. Barkin,
who resigned as a director of the Board of Directors as of December 31,
2007, was sensitive to conflicts of interest.
He recused himself from deliberations and voting in connection with all
matters related to his employment compensation.
In
97
addition, when it determines that it would be
appropriate to do so, the Board of Directors sets aside, during its regularly
scheduled meetings, time for meeting without any members of management
(including the CEO) or any non-independent directors present. During the 2007
year, five meetings were so held.
The Board of Directors has adopted a practice that the Chairman of the
Board of Directors and the CEO of the Company are separate individuals. Mr. Brian King*, the Chairman of the
Board of Directors, is an independent director.
The Chairman provides leadership to the Board of Directors with respect
to its functions as described in the Board of Directors mandate and oversees
the logistics of the operations of the Board of Directors. As Mr. Brian King is not seeking
re-election, the directors will elect a new Chairman following the Meeting of
the shareholders.
|
|
* Mr. King will
not seek re-election as a director at our next annual shareholders meeting.
|
The Board of Directors requires that any director recuse himself from
any decision to be made in any transaction in which the director has a material
interest.
Our by-laws provide that the members of the Board of Directors are
elected to a renewable one year term.
All of our current members of the Board of Directors and Audit
Committee, Nominating and Corporate Governance Committee and Human Resources
and Compensation Committee were elected or ratified at a shareholders meeting
held in May 2007.
Committees of the Board of
Directors
The Board of Directors has three standing committees: the Audit Committee, the Human Resources and
Compensation Committee and the Nominating and Corporate Governance
Committee. To maintain appropriate
independence, no members of management sit on any of the three standing
committees.
From time to time, special committees of the Board of Directors are
appointed to consider special issues, in particular, any issues which could
potentially involve related party transactions.
Committees of the Board of Directors and individual Board members may
engage independent consultants and outside advisors at the expense of the
Company, where reasonable and appropriate, to assist them in discharging their
responsibilities.
Audit Committee
The Audit Committee is responsible for reviewing the Companys financial
reporting procedures and internal controls.
The Committee is also responsible for reviewing quarterly financial
statements and the annual financial statements and earnings announcements prior
to their approval by the full Board of Directors and communicating regularly
with the Companys external auditors.
The Company believes the oversight responsibility of the Committee
provides a key stewardship role for the Committee in the Companys financial
disclosure issues, internal controls, risk management, corporate finance and
related matters.
In reviewing the audited financial statements of the Company, the
Committee discusses the quality, not just the acceptability, of the accounting
principles, the reasonableness of significant judgments, and the clarity of
disclosure in the financial statements.
In addition, the Committee discusses with the Companys
Independent Registered
Chartered Accountants
the overall scope and plans for their
98
audit.
The Committee meets with the
Independent Registered Chartered
Accountants
, with and without management present, to discuss the results of their
examination and the overall quality of the Companys financial reporting. The Committee also carefully reviews evolving
Canadian and U.S. audit committee regulations and best practices to ensure
corporate alignment with the spirit and intent of such regulations and
practices.
In February 2007, May 2005, February 2005 and April 2004,
the Board of Directors approved amendments to the Charter for the Audit Committee,
which was initially approved in February 2003. The Charter is available on the Companys
website at
www.draxis.com
and was filed on
SEDAR (
www.sedar.com
) on March 30,
2007
.
The Charter specifies that the purpose of the
Committee is to assist the Board of Directors with its oversight
responsibilities by:
·
Reviewing the integrity of the
consolidated financial statements of the Company;
·
Recommending to the Board of Directors
the appointment of the Independent Registered Chartered Accountants and
reviewing the Independent Registered Chartered Accountants qualifications and
independence;
·
Reviewing the performance of the
Companys Independent Registered Chartered Accountants;
·
Reviewing the timely compliance by the
Company with all legal and regulatory requirements for audit and related
financial functions of the Company;
·
Reviewing financial information contained
in public filings of the Company prior to filing;
·
Reviewing earnings announcements of the
Company prior to release to the public and any other press release containing
financial information;
·
Overseeing the Companys systems of and
compliance with internal financial controls and managements reporting on
internal controls and risk management;
·
Reviewing the Companys auditing, accounting
and financial reporting processes; and
·
Dealing with all complaints regarding
accounting controls and auditing matters.
In accordance with the Audit Committee Charter, the Audit Committee
pre-approves all auditing services and permitted non-audit services (including
fees and terms thereof) to be performed for the Company or its subsidiaries by
its Independent Registered Chartered Accountants.
In May 2003, the Audit Committee also established whistleblowing
procedures for the confidential submission of concerns by employees of the
Company or any of its subsidiaries about accounting, internal controls or
auditing issues. The Company provides
the employees with reminders of the existence of such procedures on an annual
basis.
Composition of the Audit Committee
The
Committee is currently composed of four directors, all of whom are independent
directors, as independence is defined under Rule 10A-3 of the
Exchange Act
, as amended, and all of whom
are financially literate. The members of
the Audit Committee are Messrs. Samuel Sarick (Chairman), Bruce Simpson,
George Darnell and Rolf Henel. Mr. Henel
is the Companys designated financial expert in accordance with applicable
regulatory and legislative requirements.
The designation of Mr. Henel as an Audit Committee financial expert
does not make Mr. Henel an expert for any other purpose, impose any
duties, obligations or liability on Mr. Henel that are greater than those
imposed on members of the Audit Committee and Board of Directors who do not carry
his designation, or affect the duties, obligations or liability of any other
member of the Audit Committee.
99
Relevant Education and Experience
All of the members of the Audit Committee are financially literate. Each of the Audit Committee members (i) has
an understanding of the accounting principles used by the issuer to prepare its
financial statement, (ii) the ability to assess the general application of
such accounting principles in connection with the accounting for estimates,
accruals and reserves; (iii) has practical experience in preparing,
auditing, analyzing or evaluating financial statements, and (iv) has an
understanding of internal controls and procedures for financial reporting.
In determining whether a director: (i) is financially literate,
the Board of Directors considers whether the director has the ability to read
and understand a balance sheet, an income statement, a cash flow statement and
the notes attached thereto; and (ii) has accounting or related financial
experience, the Board of Directors considers whether the director has the
ability to analyze and interpret a full set of financial statements, including
the notes attached thereto.
Mr. Samuel Sarick has over 50 years of experience as President and
CEO of a major real estate corporation.
Mr. Bruce Simpson has an MBA degree and has served as President of
the Genpharm division of E Merck and President and Chief Executive Officer of
Medeva Pharmaceuticals in the United States.
Mr. George Darnell has an MBA degree and is the retired President
of the Dade Division and Executive Vice President of the Baxter Diagnostics
Group of Baxter International.
Mr. Rolf Henel has an MBA degree in Finance and Accounting and was
a treasurer and then President of Cyanamid International, Lederle Division.
Human Resources and Compensation Committee
The Human Resources and Compensation Committee oversees overall
corporate policy with respect to compensation and benefits and makes
recommendations to the Board of Directors on, among other things, the
compensation of senior management. In
assessing compensation issues, the Committee reviews and examines in detail the
performance of senior management.
Each of the three current members of the Committee is an independent
director. The members of the Human
Resources and Compensation Committee are Messrs. Brian King (Chairman)*,
Bruce Simpson and John Vivash.
|
|
* Mr. Brian King
will not seek re-election as a director at our next annual shareholders meeting.
|
In May 2005,
the Board of Directors approved amendments to the Charter for the Human
Resources and Compensation Committee, which was initially approved in April 2004. The Charter is available on the Companys
website at www.draxis.com. The Charter
specifies that the purpose of the Committee is to assist the Board of Directors
with its oversight responsibilities by reviewing and reporting on:
·
Managements succession plans for
executive officers, with special emphasis on CEO succession, and including
specific development plans and career planning for potential successors;
·
Compensation philosophy of the
organization, including a compensation strategy and compensation policies for
executive officers, as proposed by the CEO;
·
Recommendations to the Board of Directors
for the appointment of the CEO and other executive officers, corporate
objectives that the CEO and such other executive officers, as the case may be,
100
are responsible
for meeting, assessment of the CEO against these objectives, monitoring of the
CEOs performance, and providing advice and counsel in the execution of his
duties;
·
Total compensation plans including
adequacy and form of compensation realistically reflecting the responsibilities
and risks of the position for the CEO of the Company and, in connection
therewith, consider appropriate information, including information from the
Board of Directors with respect to the overall performance of the CEO;
·
Compensation for executive officers,
annual adjustment to executive officer salaries, and the design and
administration of short and long-term incentive plans, stock options, benefits
and perquisites as proposed by the CEO;
·
Employment and termination arrangements
for executive officers;
·
Adoption of new or significant
modifications to pay and benefit plans;
·
Significant changes to the Companys
organizational structure relating to human resources function;
·
The Committees proposed executive
compensation report to be contained in the Companys annual Management Proxy
Circular;
·
Management development programs for the
Company;
·
Any special employment contracts or
arrangements with executive officers of the Company including any contracts
relating to a change of control;
·
Remuneration for members of the Board of
Directors and Committees thereof, including adequacy and form of compensation
realistically reflecting the responsibilities and risks of the positions and
recommending changes where applicable;
·
Compliance by the Company and its
subsidiaries with all applicable employment and labor legislation; and
·
The performance of the Committee and the
effectiveness of the Committees members.
There is currently no set date for the retirement of the existing CEO, Mr. Dan
Brazier.
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee is responsible for
recommending annually the members of the Board of Directors proposed for
election to the Board of Directors, recommending new candidates for Board of
Directors membership, monitoring the composition and the Board of Directors and
suggesting appropriate changes. It seeks
on behalf of shareholders well-qualified candidates to nominate as directors
(individuals who provide a balance in terms of their backgrounds and experience
in different industries and professions).
It is also responsible for making recommendations to the full Board of Directors
with respect to developments in the area of corporate governance and best
practices.
Each of the three current members of the Committee is an independent
director. The members of the Nominating
and Corporate Governance Committee are Messrs. John Vivash (Chairman),
George Darnell and Rolf Henel.
In May 2005, the Board of Directors approved
amendments to the Charter for the Nominating and Corporate Governance
Committee, which was initially approved in April 2004. The Charter is available on the Companys
website at www.draxis.com. The Charter
specifies that the purpose of the Committee is to assist the Board of Directors
with its oversight responsibilities by:
·
Establishing
a policy and procedure for identifying
and selecting potential nominees for the Board of Directors, including
considering the competencies and skills that the Board of Directors should
possess and the competencies and skills of each existing and potential
director;
101
·
Monitoring Board of Directors size and
composition and suggesting changes in this respect where appropriate;
·
Recommending annually members for
election to the Board of Directors;
·
Identifying and recommending new
candidates for Board of Directors membership;
·
Developing the Companys approach to
governance issues and making recommendations to the Board of Directors in the
area of corporate governance practices of the Board of Directors;
·
Preparing and reviewing with the Board of
Directors an annual performance evaluation of the effectiveness of individual
Board members and the Board of Directors and its Committees. The assessment of the Board of Directors
examines its effectiveness as a whole and specifically reviews areas that the
Board of Directors and/or management believe could be improved to ensure the
continued effectiveness of the Board of Directors in the execution of its
responsibilities;
·
Developing and recommending to the Board
of Directors standards to be applied to assess material relationships between
the Company and its Directors in accordance with conflict of interest
standards;
·
Reviewing annually the risks identified
by the Audit Committee with respect to the risk management policies and
procedures of the Company and to ensure such risks are appropriately identified
in the Companys public disclosure documentation;
·
Revising, as appropriate, in accordance
with best practices and legal requirements, the Code of Ethics and Business
Conduct for directors, officers and employees, as well as the Disclosure and
Insider Trading Policy for the Company to address, among other things,
procedures to monitor insider trading activities, to prevent selective
disclosure and to mandate trading blackouts and corporate quiet periods;
·
Monitoring compliance with any Board of
Directors mandated Director minimum shareholding requirements and monitoring
attendance by Directors at Board of Directors and Committee meetings;
·
Reviewing the Charter periodically and
recommending any changes required to its scope and content to the Board of
Directors; and
·
Carrying out any other duties or
responsibilities expressly delegated to the Committee by the Board of
Directors.
Special Committee
As stated above, from time to time, special committees
of the Board of Directors are appointed to consider special issues. On May 10, 2006, the Board constituted a
Special Committee currently comprised of Mr. Brian King*, Mr. Sam
Sarick, Mr. John Vivash and Mr. Bruce Simpson, who became a member on
October 31, 2007, each an independent director, in order to determine the
long term strategy of the Company and the opportunities available to it and its
subsidiaries for long term growth.
* Mr. Brian King will not seek re-election
as a director at our next annual shareholders meeting.
Decisions Requiring Approval
by the Board of Directors
In addition to those matters that must, by law, be approved by the Board
of Directors, certain other significant matters relating to the business and
affairs of the Company require prior approval of the Board of Directors. These matters include:
(i)
the approval of the quarterly and annual
financial statements and earnings announcements;
(ii)
the approval of managements discussion
and analysis of financial results;
(iii)
the approval of the Companys strategic
business plans and directions;
102
(iv)
any related party transaction or any
transaction involving any officer or director, regardless of materiality; and
(v)
any disposition or expenditure in excess
of CDN$1,000,000.
Orientation of New Directors
and Continuing Education
In orienting new members to the Board of Directors,
members are provided with an opportunity to visit the Companys facilities and
to meet with management and other members of the Board of Directors to discuss
and understand the Companys business.
With respect to continuing
education of the directors, detailed documentation and presentations are
regularly provided to directors relating to the current business plan and
current policies of the Company as well as ongoing developments in the industry
areas in which the Company operates as well as legislative changes affecting
the Company. All of the Companys
executives are available for discussions with directors concerning any
questions or comments which may arise between meetings.
Performance of the Board of
Directors
The Board of Directors regularly considers
and assesses its performance relating to its effectiveness, size, compensation
policies and assessment of management performance. In this regard, in December 2007, the
directors completed a Board Effectiveness Survey prepared by the Nominating and
Corporate Governance Committee in which they gave assessments on issues related
to Board of Directors responsibility, operations and effectiveness. The results of this survey were forwarded to
the Chairman of the Nominating and Corporate Governance Committee, who shared
the results with all of the Board members.
In December 2007, directors also completed a Board Evaluation
Survey prepared by the Nominating and Corporate Governance Committee whereby
each director assessed the performance of each other director of the Board of
Directors. The Chairman of the Nominating
and Corporate Governance Committee advised each director of the assessment so
received and forwarded a copy of each of the assessments to the Chairman of the
Board.
CEO Performance
On an annual basis, the Companys President and CEO circulates proposed
operating and strategic plans which are discussed and, if appropriate, adopted
by the Board of Directors. The Board of
Directors met in December 2007 to review the Companys one year operating
plan and three year strategic plan.
These strategic plans form the basis of the corporate objectives which
the CEO is responsible for meeting. The
Human Resources and Compensation Committee of the Board of Directors assesses
the CEOs performance against the goals established and agreed to and
recommends his compensation to the Board of Directors as a whole.
Shareholder Feedback and
Communication
The Company maintains an investor relations department headed by an
Executive Director, Investor Relations, which reports directly to the President
and CEO of the Company. In addition,
investor relations experts are retained from time to time by the Company to
advise on issues and best practices for investor relations. The Company communicates regularly with its
shareholders through annual and quarterly reports. At the Companys annual general meeting of
shareholders, a full opportunity is afforded for shareholders to ask questions
concerning the Companys business. Each
shareholder and investor inquiry receives a prompt response from the investor
relations department or an appropriate officer of the Company. Information about the Company, including
annual reports, interim financial reports and recent news releases, are also
available on the Companys website at
www.draxis.com
. In
103
addition, the Company provides the opportunity
for investors in both Canada and the U.S. to pose questions to senior
management, including the CEO, the Chief Operating Officer, the Chief Financial
Officer and the Executive Director, Investor Relations through public forums such
as conference calls and webcasts.
Board of Directors
Expectations of Management
Management is responsible for the day-to-day operations of the Company
and is expected to implement the approved operating and strategic business
plans within the context of authorized budgets and corporate policies and
procedures. The information which
management provides to the Board of Directors is critical. Management is expected to report regularly to
the Board of Directors in a comprehensive, accurate and timely fashion on the
business and affairs of the Company and any legislative changes which affect
the Company. The Board of Directors
monitors the nature of the information requested by and provided to it so that
it can effectively identify issues and opportunities for the Company.
Employees
As at December 31, 2007,
the Company and its subsidiaries employed a total of 497 employees. The DRAXIS Pharma division is the largest
employer with 389 employees, all located in Kirkland, Québec. The present
collective agreement at DRAXIS Pharma terminates on April 30, 2008. We are presently preparing to negotiate a new
collective agreement with the union and cannot assure you that we will
negotiate the same terms as the existing agreement. See Risk Factors Risks Related to our
Company Our Business Could be Harmed if there were a Dispute or Disruption
with our Unionized Employees. The DRAXIMAGE division employs 97 people all in
Kirkland, Québec, none of which are unionized.
The Company itself employs 11 people, the majority of whom are located
in Kirkland, Québec, none of which are unionized. At December 31, 2006 and 2005, the
Company and its subsidiaries had 504 and 492 employees, respectively.
Item 7. Major Shareholders and Related Party
Transactions
The Company is not aware of any company, foreign government or natural
or legal person that owns or controls the Company, directly or indirectly.
To the knowledge of the directors and officers of the Company as of December 31,
2007, the following are the only persons who, as at the dates mentioned below,
beneficially own, directly or indirectly, or exercise control over our common
shares carrying more than five percent (5%) of the votes attached to all of
those shares.
Identity of Person or Group
|
|
Amount Owned
|
|
Percent of Class
|
|
Natcan
Investment Management Inc.
|
|
4,032,202 common shares
|
|
9.6
|
%
|
|
|
|
|
|
|
Neil Gagnon
|
|
3,431,489 common shares
|
|
8.2
|
%
|
|
|
|
|
|
|
Mackenzie
Financial Corporation
|
|
3,489,500 common shares
|
|
8.3
|
%
|
|
|
|
|
|
|
Beutel,
Goodman & Company Ltd
|
|
3,558,250 common shares
|
|
8.5
|
%
|
|
|
|
|
|
|
Acuity
Investment Management Inc.
|
|
2,669,400 common shares
|
|
6.3
|
%
|
Based on the Schedule 13G public filings and Early Warning Reports under
National Instrument 62-103 in Canada made by Natcan Investment Management Inc.
during 2006 and 2007, the percentage of
104
our common stock beneficially owned by Natcan
Investment Management Inc. increased from 8.9% as at December 31, 2006 to
9.6
% as at December 31,
2007.
Based on the Schedule 13G public filings made by Neil Gagnon during 2006
and 2007, the percentage of our common stock beneficially owned by Neil Gagnon
increased from 7.0% in 2006 to
8.2
% as at December 31, 2007.
Based on the Schedule 13G public filings made by Mackenzie Financial
Corporation during 2006 and 2007, the percentage of our common stock owned by
Mackenzie Financial Corporation decreased from 10.9% as at December 31,
2006 to
8.3
% as at December 31,
2007.
Based on the Schedule 13G public filings made by Beutel, Goodman &
Company Ltd, during 2006 and 2007, the percentage of our common stock owned by
Beutel, Goodman & Company Ltd increased from 7.3% as at December 31,
2006 to 8.5% as at December 31, 2007.
Based on the Schedule 13G public filings made by Acuity Investment
Management Inc., the percentage of our common stock owned by Acuity Investment
Management Inc. is 6.3% as at December 31, 2007.
To our knowledge, as of
March 18
, 2008,
19,390,633
common shares (
46.1
%
of the outstanding common shares at that date) were held by
482
shareholders of
record whose registered addresses were in the United States. The Company has no knowledge of any other
shares held beneficially in the United States.
As of March 18, 2008, to our knowledge
there were a total of 955
shareholders of record holding 42,062,538
common shares issued and outstanding.
The building which
housed the Companys head office premises at 6870 Goreway Drive in Mississauga,
Ontario until February 29, 2008, is owned 50% by Samuel Sarick Limited, a
corporation wholly owned by Mr. Sarick, a director of the Company. The original lease for the premises was
entered into on April 25, 1994 between Samuel Sarick Limited, Kentlake
Construction Limited and Anec Investments Limited, as landlord, and the
Company, as tenant. The lease renewal
was negotiated between the Company and Samuel Sarick Limited on an arms-length
basis with the assistance of Colliers International retained by the Company and
was renewed with the approval of the Board of Directors effective May 1,
1999 for a period of five years and renewed again on April 26, 2004 for a
period of two years, which expired on May 31, 2006. The Company leased the premises on a month to
month basis on the same terms and conditions as the ones which expired on May 31,
2006 until February 29, 2008. The
Company believes that the lease terms were consistent with arms length
comparables and that the annual rent payable of CDN$139,374
was at fair market value. The Company
ceased leasing the premises on February 29, 2008.
The Company has,
in the past, made loans to certain key management personnel in connection with
its incentive plans and as inducements to enter into employment
agreements. These plans have been
discontinued, and there will be no further indebtedness under said plans. All outstanding loans were repaid in May 2005.
Item
8. Financial Information
The Companys Consolidated Financial Statements are
attached as pages F-1 through F-28.
There have been no significant changes since the date of the financial
statements.
105
Legal/Arbitration Proceedings
From time to time,
the Company becomes involved in legal proceedings and claims which arise in the
ordinary course of business. With the
exception of the matters described below, the Company considers that the ultimate
liability with respect to any known actions will not materially affect the
business, financial position, results of operations or cash flows of the
Company.
In 1998, a
Canadian legal proceeding was launched against us and our subsidiary DAHI by a
former consultant, Jozsef Knoll, claiming royalty entitlements based on the net
profit from sales of
ANIPRYL
®. Total damages claimed are $100 million,
including a claim to certain shares of DAHI.
However, the plaintiff has taken no steps in the last seven years to move
the claim forward. While we believe that
we have good defenses to the Knoll proceeding, this dispute may not be resolved
in our favor, if it is pursued. It is
possible that a court or arbitration tribunal may find us to be in breach of
certain agreements, or infringing validly issued patents of third parties or
practicing the intellectual property of others.
In that event, in addition to the cost of defending the underlying
proceeding, we may have to pay license fees, additional royalties and/or damages
and may be ordered to assign certain
ANIPRYL®-
related
patents and be prohibited from conducting certain activities. Under such circumstances, we could incur
substantial loss and our business could be negatively affected.
On July 22,
2005, we announced that, together with other defendants, we had received a
Statement of Claim filed before the Superior Court of Justice of Ontario
alleging that Permax
Ò
, a drug that we distributed in Canada for a third party manufacturer
prior to July 2003, causes compulsive/obsessive behaviour, including
pathological gambling. The plaintiff is
seeking to have this action certified as a class action. We believe this claim against us is without
merit and we intend to vigorously defend this proceeding and any motion for certification. Prior to July 2003, Permax
Ò
was distributed in Canada by DRAXIS Pharmaceutica, our Canadian
pharmaceutical sales and marketing division.
In July 2003, we sold the DRAXIS Pharmaceutica division to
Shire. As of December 31, 2007,
there have been no developments in this action.
On February 29,
2008, the plaintiff served an Amended Statement of Claim and a Motion Record in
support of the plaintiffs motion for certification of this action as a class
proceeding. The defendants must file a
response to plaintiffs motion for certification by July 31, 2008.
Item 9. The
Offer and Listing
The Companys common shares
are listed on The Toronto Stock Exchange (the TSX) under the symbol DAX and
the NASDAQ National Market System (NASDAQ) in the United States under the
symbol DRAX.
The following table sets
forth, in Canadian dollars, the per share high and low sales prices on the TSX
for the five most recent full financial years:
Years
|
|
High ($)
|
|
Low ($)
|
|
2003
|
|
4.75
|
|
1.61
|
|
2004
|
|
7.90
|
|
4.12
|
|
2005
|
|
7.05
|
|
4.61
|
|
2006
|
|
5.80
|
|
4.32
|
|
2007
|
|
7.59
|
|
3.29
|
|
The following table sets forth, in Canadian dollars, the per share high
and low sales prices on the TSX by fiscal quarter for 2007 and 2006.
106
2007
|
|
High
($)
|
|
Low
($)
|
|
First Quarter
|
|
7.49
|
|
5.36
|
|
Second Quarter
|
|
7.59
|
|
6.00
|
|
Third Quarter
|
|
7.00
|
|
4.56
|
|
Fourth Quarter
|
|
5.40
|
|
3.29
|
|
2006
|
|
High
($)
|
|
Low
($)
|
|
First Quarter
|
|
5.60
|
|
5.00
|
|
Second Quarter
|
|
5.44
|
|
4.32
|
|
Third Quarter
|
|
5.37
|
|
4.71
|
|
Fourth Quarter
|
|
5.80
|
|
4.95
|
|
The following
table sets forth, in Canadian dollars, the per share high and low sales prices
and the trading volumes on the TSX from January 2007 to February 2008:
Months
|
|
High
($)
|
|
Low
($)
|
|
Trading Volumes
(#)
|
|
January 2007
|
|
6.15
|
|
5.36
|
|
1,536,500
|
|
February 2007
|
|
6.35
|
|
5.81
|
|
2,357,200
|
|
March 2007
|
|
7.49
|
|
6.08
|
|
3,069,200
|
|
April 2007
|
|
7.59
|
|
6.29
|
|
2,051,300
|
|
May 2007
|
|
6.63
|
|
5.75
|
|
1,563,900
|
|
June 2007
|
|
6.69
|
|
6.00
|
|
1,051,700
|
|
July 2007
|
|
7.00
|
|
5.21
|
|
2,784,100
|
|
August 2007
|
|
5.68
|
|
4.56
|
|
1,446,900
|
|
September 2007
|
|
5.90
|
|
4.81
|
|
928,800
|
|
October 2007
|
|
5.40
|
|
4.88
|
|
979,000
|
|
November 2007
|
|
4.44
|
|
3.29
|
|
3,825,700
|
|
December 2007
|
|
4.13
|
|
3.31
|
|
1,713,300
|
|
January 2008
|
|
4.25
|
|
3.57
|
|
1,021,584
|
|
February 2008
|
|
4.09
|
|
3.45
|
|
1,981,646
|
|
The following
table sets forth, in U.S. dollars, the per share high bid and low asked prices
on NASDAQ for the five most recent full financial years:
Years
|
|
High
($)
|
|
Low
($)
|
|
2003
|
|
3.70
|
|
1.09
|
|
2004
|
|
5.94
|
|
3.29
|
|
2005
|
|
5.84
|
|
3.93
|
|
2006
|
|
5.08
|
|
3.90
|
|
2007
|
|
6.64
|
|
3.27
|
|
107
The following table sets forth, in U.S. dollars, the per share high and
low asked prices on NASDAQ in U.S. dollars, by fiscal quarter for 2007 and
2006:
2007
|
|
High
($)
|
|
Low
($)
|
|
First Quarter
|
|
6.49
|
|
4.56
|
|
Second Quarter
|
|
6.64
|
|
5.19
|
|
Third Quarter
|
|
6.53
|
|
4.26
|
|
Fourth Quarter
|
|
5.50
|
|
3.27
|
|
2006
|
|
High
($)
|
|
Low
($)
|
|
First Quarter
|
|
4.85
|
|
4.27
|
|
Second Quarter
|
|
4.55
|
|
3.90
|
|
Third Quarter
|
|
4.75
|
|
3.96
|
|
Fourth Quarter
|
|
5.08
|
|
4.31
|
|
The following table sets forth, in U.S. dollars, the per share high and
low sales prices
and the trading volumes
on NASDAQ
from January 2007 to February 2008
:
Months
|
|
High
($)
|
|
Low
($)
|
|
Trading Volumes
(#)
|
|
January 2007
|
|
5.26
|
|
4.56
|
|
1,579,800
|
|
February 2007
|
|
5.51
|
|
4.91
|
|
3,826,900
|
|
March 2007
|
|
6.49
|
|
5.20
|
|
4,559,000
|
|
April 2007
|
|
6.64
|
|
5.67
|
|
3,217,300
|
|
May 2007
|
|
6.10
|
|
5.19
|
|
2,560,400
|
|
June 2007
|
|
6.25
|
|
5.71
|
|
2,183,300
|
|
July 2007
|
|
6.53
|
|
4.90
|
|
3,156,000
|
|
August 2007
|
|
5.38
|
|
4.26
|
|
1,693,500
|
|
September 2007
|
|
5.60
|
|
4.57
|
|
1,140,500
|
|
October 2007
|
|
5.50
|
|
4.82
|
|
878,300
|
|
November 2007
|
|
4.87
|
|
3.53
|
|
1,850,200
|
|
December 2007
|
|
4.08
|
|
3.27
|
|
884,900
|
|
January 2008
|
|
4.25
|
|
3.55
|
|
1,077,900
|
|
February 2008
|
|
4.17
|
|
3.43
|
|
953,000
|
|
The transfer agent
of the Company is Computershare Investor Services Inc., Stock Transfer
Services, located at 100 University Avenue, Toronto, Ontario, Canada, M5J 2Y1.
Item 10. Additional Information
Bylaws and Articles of
Amalgamation
The Companys Articles of Amalgamation are on file with the Corporations
Directorate of Industry Canada under Corporation Number 357288-9. The Articles of Amalgamation do not include a
stated purpose and do not place any restrictions on the business that the
Company may carry on.
108
Inspection
Rights of Shareholders
Under the CBCA, shareholders are entitled to be provided with a copy of
the list of registered shareholders of the company. In order to obtain the shareholder list, the
Company must be provided with an affidavit including, among other things, a
statement that the list will only be used for the purposes permitted by the
CBCA. These permitted purposes include
an effort to influence of the voting of shareholders of the Company, an offer
to acquire securities of the Company and any other matter relating to the
affairs of the Company. The Company is
entitled to charge a reasonable fee for the provision of the shareholder list
and must deliver that list no more than ten days after receipt of the affidavit
described above.
Shareholders of the Company have the right to inspect certain corporate
records, including its articles and by-laws and minutes of meetings and
resolutions of the shareholders.
Shareholders have no statutory right to inspect minutes of meetings and
resolutions of directors of the Company.
Shareholders of the Company have the right to certain financial
information respecting the Company. In
addition to the annual and quarterly financial statement required to be filed
under applicable securities laws, the Company is required to place before every
annual meeting of shareholders its audited comparative annual financial
statements. In addition, shareholders
have the right to examine the financial statements of each of its subsidiaries
and any other corporate entity whose accounts are consolidated in the financial
statements of the Company.
Directors
The minimum number of directors of the Company is one (1) and the
maximum number is twelve (12). In
accordance with the Companys bylaws and the Act, a majority of its directors
must be residents of Canada. In order to
serve as a director, a person must be a natural person at least 18 years of
age, of sound mind and not bankrupt.
Neither the Articles of Amalgamation, bylaws, nor the Act, impose any
mandatory retirement requirements for directors.
Under the Companys bylaws and the Articles of Amalgamation, a director
of the Company need not be a shareholder.
However, in June 2001 the Board of Directors established a
corporate policy requiring each current Director to acquire by June 2004
(or in the case of future Board of Directors members, within three years of
their appointment) common shares in the Company equal to five times his or her
annual honorarium. All directors who
were to comply with this requirement by June 2004 were in compliance as of
said date. In February 2005, the
Board of Directors adopted a resolution amending this policy to fix the number
of common shares to be so held at 15,000.
Compliance with this policy is monitored annually by the Nominating and
Corporate Governance Committee. As at March 18,
2008, all directors were in compliance with this requirement.
A director who is a party to, or who is a director or officer of, or has
a material interest in, any person who is a party to a material contract or
transaction or proposed material contract or transaction with the Company must
disclose to the Company the nature and extent of his or her interest at the
time and in the manner provided by the Act.
The Act prohibits such a director from voting on any resolution to
approve the contract or transaction unless the contract or transaction:
·
relates primarily
to his or her remuneration as a director, officer, employee or agent of the
Company or an affiliate;
·
is for indemnity
or insurance for directors liability as permitted by the Act; or
·
is with an
affiliate of the Company.
109
The Board of Directors may, on behalf of the Company and without
authorization of its shareholders:
·
borrow money upon
the credit of the Company;
·
issue, reissue,
sell or pledge debt obligations of the Company;
·
give a guarantee
on behalf of the Company to secure performance of an obligation of any person;
and
·
mortgage,
hypothecate, pledge or otherwise create a security interest in all or any
property of the Company, owned or subsequently acquired, to secure any
obligation of the Company.
The Act prohibits the giving of a guarantee to any shareholder,
director, officer or employee of the Company or of an affiliated corporation or
to an associate of any such person for any purpose or to any person for the
purpose of or in connection with a purchase of a share issued or to be issued
by the Company or its affiliates, where there are reasonable grounds for
believing that the Company is or, after giving the guarantee, would be unable
to pay its liabilities as they become due, or the realizable value of the
Companys assets in the form of assets pledged or encumbered to secure a
guarantee, after giving the guarantee, would be less than the aggregate of the
Companys liabilities and stated capital of all classes.
These borrowing powers may be varied by the Companys bylaws or its
Articles of Amalgamation. However, the
Companys bylaws and Articles of Amalgamation do not contain any restrictions
on or variations of these borrowing powers.
The general duties of a director or officer of the Company under the
CBCA are to act honestly and in good faith with a view to the best interests of
the Company and to exercise the care, diligence and skill that a reasonably
prudent person would exercise in comparable circumstances. Any breach of these duties may lead to
liability to the Company and its shareholders for breach of fiduciary
duty. In addition, a breach of certain
provisions of the CBCA, including the improper payment of dividends or the
improper purchase or redemption of shares, will render the directors who
authorized such action liable to account to the Company for any amounts
improperly paid or distributed.
Share Capitalization
The Companys Articles of Amalgamation authorize the issuance of an
unlimited number of common shares (42,062,538 of which are outstanding as of March 18,
2008), an unlimited number of preferred shares (none of which are issued and
outstanding), and 2,000,000 Employee Participation Shares (2,000,000 of which
have been issued and none of which remain outstanding as of March 18,
2008). The Articles of Amalgamation do
not authorize the issuance of any other class of shares.
Common Shares
The holders of the common shares of the Company are entitled to receive
notice of and to attend all meetings of the shareholders of the Company and
have one vote for each common share held at all meetings of shareholders. The directors are elected at each annual
meeting of shareholders and do not stand for re-election at staggered
intervals.
110
The holders of common shares are entitled to receive dividends and the
Company will pay dividends, as and when declared by the Board of Directors, out
of moneys properly applicable to the payment of dividends, in such amount and
in such form as the Board of Directors may from time to time determine, subject
to the rights of the holders of any other class of shares of the Company
entitled to receive dividends in priority to or ratably with the holders of the
common shares, and all dividends which the Board of Directors may declare on
the common shares shall be declared and paid in equal amounts per share on all
common shares at the time outstanding.
In the event of the dissolution, liquidation or winding-up of the
Company, whether voluntary or involuntary, or any other distribution of assets
of the Company among its shareholders for the purpose of winding-up its
affairs, the holders of the common shares shall, subject to the rights of the
holders of any other class or shares of the Company entitled to receive the
assets of the Company upon such distribution in priority to or ratably with the
holders of the common shares, be entitled to participate ratably in any
distribution of the assets of the Company.
Preferred Shares
The preferred shares of the Company may at any time or from time to time
be issued in one or more series. No
preferred shares of the Company have been issued to date. Preferred shares shall be entitled to preference
over the common shares and any other shares of the Company ranking junior to
the preferred shares and the distribution of assets in the event of any
liquidation and common dissolution or winding-up of the Company, whether
voluntary or involuntary, or other distribution of the assets of the Company
among its shareholders for the purpose of winding-up its affairs. The preferred shares of each series shall
rank in parity with the preferred shares of every other series with respect to
priority in the payment of dividends and in the distribution of assets in the
event of liquidation, dissolution or winding-up of the Company.
Subject to the provisions relating to any particular series, the Company
may redeem the whole or any part of the preferred shares on any one or more
series outstanding from time to time at such price or prices as may be
applicable to such series by giving at least thirty (30) days prior notice in
writing of the intention of the Company to redeem such shares to each person
who at the date of giving such notice is the registered holder of preferred
shares to be redeemed.
The preferred shares may be issued on the authorization of the
directors, without further authorization by the shareholders, but the issuance
of any preferred share is subject to the general duties of the directors under
the CBCA to act honestly and in good faith with a view to the best interests of
the Company and to exercise the care, diligence and skill that a reasonably
prudent person would exercise in comparable circumstances. The issuance of any preferred shares in the
face of a take-over bid for the Company would be examined in light of these
duties of the directors and other applicable case law.
Shareholder Actions
The
CBCA provides that shareholders of the Company may, with leave of a court,
bring an action in the name of and on behalf of the Company for the purpose of
prosecuting, defending or discontinuing an action on behalf of the
Company. In order to grant leave to
permit such an action, the CBCA provides that the court must be satisfied that
the directors of the Company were given adequate notice of the application, the
shareholder is acting in good faith and that it appears to be in the Companys
best interests that the action be brought.
111
Employee Participation Shares
On February 16, 1995, the Board of Directors of the Company
authorized the issuance of 975,000 Series A Participation Shares; on December 18,
1995, the Board of Directors of the Company authorized the issuance of 555,000 Series B
Participation Shares and on May 12, 1999, the Board of Directors of the
Company authorized the issuance of 470,000 Series C Participation
Shares. The Employee Participation Share
Purchase Plan (the EP Plan) was discontinued effective December 4, 2002.
Each participation share entitles the holder to receive cash dividends,
if any, as may from time to time be declared payable thereon, at the same time
as dividends, if any, are paid on the common shares of the Company, in an
amount for each participation share of a particular series which is equal to
the proportion of the amount of the dividend declared on each common share that
the subscription price of such participation share is of the fair market value
at the date of issuance of such participation share.
In the event of a proposal, order or resolution for the liquidation,
dissolution or winding-up of the Company, whether voluntary or involuntary; or
on the Automatic Conversion Date (as defined in the Articles of Amalgamation
and the terms of the EP Plan); or at the option of the holder on a Conversion
Date (as defined in the Articles of Amalgamation and the terms of the EP Plan)
other than the Automatic Conversion Date (as defined in the Articles of
Amalgamation and the terms of the EP Plan), the participation shares will become
common shares, and the number of common shares a holder receives on conversion
is the number of common shares which is determined by multiplying the number of
participation shares held, or in the case of conversion on a Conversion Date
other than the Automatic Conversion Date, the number of participation shares
which the holder elects to convert, by a fraction:
1.
the numerator of which shall be the EP Share
Value(as defined in the Articles of Amalgamation and the terms of the EP Plan)
of a participation share of a particular series as at the earlier of the
Automatic Conversion Date and a Conversion Date as the case may be; and
2.
the denominator of which shall be the Fair Market
Value of a Common Share (as defined in the Articles of Amalgamation and the
terms of the EP Plan) as at the earlier of the two dates described in 1;
provided that no fractional common shares will be issued and no payment will be
made in respect of fractional common shares.
On January 14, 2004,
the 245,000 Series C participation shares, which were the only outstanding
employee participation shares, were converted into 54,896 common shares of the
Company.
Warrants
In April 2004, the Company closed an equity financing offering of
3,053,436 units consisting of one common share and one-half of one share
purchase warrant per unit. Each whole
warrant entitled its holder to acquire one common share at a price of CDN$8.50,
subject to certain adjustments, at any time prior to April 24, 2006. The warrants are transferable. Holders of
warrants do not, as such, have any voting rights or other right attaching to
the common shares until the warrants are properly exercised and common shares
issuable upon the exercise of the warrants are issued. All warrants expired unexercised on April 24,
2006.
Pursuant to the terms of the indenture relating to the warrants entered
into between the Company and Computershare Investor Services Inc., subject to
applicable law, the Company could purchase prior to April 24, 2006, by
private contract or otherwise, all of or any of the warrants then outstanding
and any warrants so purchased would have been cancelled. No warrants were so purchased.
112
Shareholder Rights Plan
On May 16, 2002, the shareholders of the Company approved a
Shareholder Rights Plan Agreement (the Rights Plan), which was reconfirmed at
the Annual General Meeting dated May 18, 2005, the principal terms of
which are as follows:
Effective Date
The Rights Plan became effective on April 23, 2002 (the Effective
Date) and was approved by shareholders of the Company at its Annual and
Special Meeting of shareholders held on May 16, 2002.
Term
The term of the Rights Plan is ten years, subject to reconfirmation by
shareholders at every third annual meeting.
Issue of Rights
One right (a Right) attaches to each outstanding common share.
Rights Exercise Privilege
The Rights will separate from the shares to which they are attached and
will become exercisable at the time (the Separation Time) that is ten trading
days after the earlier of a person having acquired, or the commencement,
announcement or other date determined by the Board of Directors in respect of a
takeover bid to acquire, 20% or more of the common shares, other than by an acquisition
pursuant to a takeover bid permitted by the Rights Plan (a Permitted Bid).
The acquisition of Beneficial Ownership (as defined in the Rights Plan)
by any person (an Acquiring Person), including others acting in concert, of
20% or more of the common shares, other than by way of a Permitted Bid, is
referred to as a Flip-in Event. Under
the Rights Plan, there are certain exceptions to that rule, including (i) the
Company or a subsidiary of the Company, (ii) a person who acquires 20% or
more of the outstanding common shares through, among other things, a share
redemption or a Permitted Bid, (iii) an underwriter or selling group
member during the course of a public distribution; or (iv) investment and
fund managers, trust companies and other persons who are managing investment
funds, pension funds or plans, estates or accounts on behalf of another person,
provided they are not making, or are not part of a group making, a takeover
bid. Any Rights held by an Acquiring
Person on or after the earlier of the Separation Time or the first date of
public announcement by the Company or an Acquiring Person that an Acquiring
Person has become such will become void upon the occurrence of a Flip-in Event.
Under the Rights Plan, a bidder is entitled to lock up any
shareholder of the Company without triggering the Rights Plan so long as the
lock-up agreement is a soft lock up, meaning the locked-up shareholder is
entitled to tender to a higher offer (so long as the higher offer is not
required under the lock-up agreement to be more than 7% higher than the first
offer).
Ten trading days after the occurrence of the Flip-in Event, the Rights
(other than those held by the Acquiring Person) will permit the holder to
purchase, for the exercise price of the Rights, common shares having a value
based on the then-prevailing market price) equal to twice such exercise price
(i.e., at a 50% discount). The exercise
price of the Rights will be equal to five times the prevailing market price at
the Separation Time.
113
The issue of the Rights is not initially
dilutive. Upon a Flip-in Event occurring
and the Rights separating from the attached shares, reported earnings per
common share on a fully diluted or non-diluted basis may be affected. Holders of Rights who do not exercise their
Rights upon the occurrence of a Flip-in Event may suffer substantial dilution.
Certificates and Transferability
Prior to the Separation Time,
the Rights will be evidenced by a legend imprinted on certificates for common
shares issued from and after the Effective Date. Rights are also attached to such shares
outstanding on the Effective Date, although share certificates issued prior to
that date will not bear such a legend.
Prior to the Separation Time, Rights will not be transferable separately
from the attached shares. From and after
the Separation Time, the Rights will be evidenced by Rights certificates which
will be transferable and traded separately from the shares.
Permitted Bid Requirements
The requirements of a Permitted Bid include the following:
·
the takeover bid
must be made by way of a takeover bid circular to all holders of common shares;
·
the takeover bid
must not permit common shares tendered pursuant to the takeover bid to be taken
up prior to the expiry of a period of not less than sixty (60) days and only if
at such time more than 50% of the common shares held by shareholders other than
the bidder, its affiliates, associates and persons acting jointly or in concert
with the bidder (the Independent Shareholders) have been tendered pursuant to
the takeover bid and not withdrawn; and
·
if more than 50%
of the common shares held by Independent Shareholders are tendered to the
takeover bid within the sixty (60) day period, the bidder must make a public
announcement of that fact and the takeover bid must remain open for deposits of
common shares for an additional ten (10) business days from the date of
such public announcement.
The Rights Plan allows a competing Permitted Bid (a Competing Permitted
Bid) to be made while a Permitted Bid is in existence. A Competing Permitted Bid must satisfy all
the requirements of a Permitted Bid except that it may expire on the same date
as the Permitted Bid, subject to the requirement that it be outstanding for a
minimum period of thirty-five (35) days.
Waiver
The Board of Directors may, prior to a Flip-in Event, waive the dilutive
effects of the Rights Plan in respect of a particular Flip-in Event (an Exempt
Acquisition) that would result from a takeover bid made by way of a takeover
bid circular to all holders of common shares, provided that in such
circumstances the Board shall be deemed to have waived the application of the
Rights Plan to any other Flip-in Event occurring as a result of a takeover bid
made by way of a takeover bid circular to all holders of common shares prior to
the expiry of any takeover bid in respect of which the Rights Plan has been
waived. The Board of Directors may also
waive the Rights Plan in respect of a particular Flip-in Event that has
occurred through inadvertence, provided that the Acquiring Person that
inadvertently triggered such Flip-in Event reduces its beneficial holdings to
less than 20% of the outstanding voting shares of the Company within fourteen
(14) days or such other period as may be specified by the Board of Directors.
114
Redemption
At any time prior to the occurrence of a Flip-in Event, the Board of
Directors may with the prior approval of the holders of the common shares or
the Rights redeem all, but not less than all, of the outstanding Rights at a price
of CDN$0.000001 each. Rights will be
deemed to have been redeemed by the Board of Directors following completion of
a Permitted Bid, Competing Permitted Bid or Exempt Acquisition.
Supplements and Amendments
The Company is authorized to make amendments to the Rights Plan to
correct any clerical or typographical error or, subject to subsequent
ratification by shareholders or Rights holders, to maintain the validity of the
Rights Plan as a result of changes in law or regulation. Other amendments or supplements to the Rights
Plan may be made with the prior approval of shareholders or Rights holders.
Action Necessary to Change Rights
of Shareholders
In order to change the rights of our shareholders, the Company would
need to amend its Articles of Amalgamation to effect the change. Such an amendment would require the approval
of holders of two-thirds of the common shares cast at a duly called special
meeting. For certain amendments such as
those creating of a class of preferred shares, a shareholder is entitled under
the Act to dissent in respect of such a resolution amending the Articles of
Amalgamation and, if the resolution is adopted and the Company implements such
changes, demand payment of the fair value of its common shares.
Meeting of Shareholders
An annual meeting of shareholders is held each
year for the purpose of considering the financial statements and reports,
electing directors, appointing auditors and for the transaction of other
business as may be brought before the meeting.
The Board of Directors has the power to call a special meeting of
shareholders at any time.
Notice of the time and place of each meeting of shareholders must be
given not less than twenty-one (21) days, nor more than fifty (50) days, before
the date of each meeting to each director, to the auditor and to each
shareholder who at the close of business on the record date for notice is
entered in the securities register as the holder of one or more shares carrying
the right to vote at the meeting. Notice
of meeting of shareholders called for any other purpose other than
consideration of the minutes of an earlier meeting, financial statements and
auditors report, election of directors and reappointment of the incumbent
auditor, must state the nature of the business in sufficient detail to permit
the shareholder to form a reasoned judgment on and must state the text of any
special resolution or bylaw to be submitted to the meeting.
The only persons entitled to be present at a meeting of shareholders are
those entitled to vote, the directors of the Company and the auditor of the
Company. Any other person may be
admitted only on the invitation of the chairman of the meeting or with the
consent of the meeting. In circumstances
where a court orders a meeting of shareholders, the court may direct how the
meeting may be held, including who may attend the meeting.
The
holders of not less than five percent of the outstanding voting shares of the
Company may requisition the directors of the Company to call a meeting of
shareholders for the purpose stated in the requisition. Except in limited circumstances, including
where a meeting of shareholders has already been
115
called and a notice of meeting already given or where
it is clear that the primary purpose of the requisition is to redress a
personal grievance against the Company or its directors, officers or
shareholders, the directors of the Company shall call a meeting of
shareholders. If the directors fail to
call a meeting of shareholders within twenty-one (21) days after receiving the
requisition, any shareholder who signed the requisition may call the meeting of
shareholders and, unless the shareholders resolve otherwise at the meeting, the
Company shall reimburse the shareholders for the expenses reasonably incurred
by them in requisitioning, calling and holding the meeting of shareholders.
The
CBCA also provides that, except in limited circumstances, a resolution in
writing signed by all of the shareholders entitled to vote on that resolution
at a meeting of shareholders is as valid as if it had been passed at a meeting
of shareholders.
Limitations on Right to Own
Securities
Neither Canadian law nor the Companys Articles of Amalgamation or
bylaws limit the right of a non-resident to hold or vote common shares of the
Company, other than as provided in the Investment Canada Act (the Investment
Act). The Investment Act prohibits
implementation of certain direct reviewable investments by an individual,
government or agency thereof, corporation, partnership, trust or joint venture
that is not a Canadian, as defined in the Investment Act (a non-Canadian),
unless, after review, the minister responsible for the Investment Act is
satisfied or is deemed to be satisfied that the investment is likely to be of
net benefit to Canada. An investment in
the common shares of the Company by a non-Canadian (other than a WTO Investor
as defined below) would be reviewable under the Investment Act if it were an
investment to acquire direct control of the Company, and the book value of the
assets of the Company were CDN$5.0 million or more (provided that immediately
prior to the implementation of the investment the Company was not controlled by
WTO Investors). An investment in common
shares of the Company by a WTO Investor (or by a non-Canadian other than a WTO
Investor if, immediately prior to the implementation of the investment, the
Company was controlled by WTO Investors) would be reviewable under the
Investment Act if it were an investment to acquire direct control of the
Company (in 2007) and the value of the assets of the Company equaled or
exceeded CDN$281.0 million. A
non-Canadian, whether a WTO Investor or otherwise, would be deemed to acquire
control of the Company for purposes of the Investment Act if he or she acquired
a majority of the common shares of the Company.
The acquisition of less than a majority, but at least one-third of the
shares, would be presumed to be an acquisition of control of the Company,
unless it could be established that the Company was not controlled in fact by
the acquirer through the ownership of the shares. In general, an individual is a WTO Investor
if he or she is a national of a country (other than Canada) that is a member
of the World Trade Organization (WTO Member) or has a right of permanent
residence in a WTO Member. A corporation
or other entity will be a WTO Investor if it is a WTO Investor-controlled
entity pursuant to detailed rules set out in the Investment Act. The United States is a WTO Member. Certain transactions involving the Companys
common shares would be exempt from the Investment Act, including:
(a)
an acquisition of the shares if the
acquisition were made in the ordinary course of that persons business as a
trader or dealer in securities;
(b)
an acquisition of control of the Company
in connection with the realization of a security interest granted for a loan or
other financial assistance and not for any purpose related to the provisions of
the Investment Act; and
(c)
an acquisition of control of the Company
by reason of an amalgamation, merger, consolidation or corporate
reorganization, following which the ultimate direct or indirect control in fact
of the Company, through the ownership of voting interests, remains unchanged.
116
Dividend Policy
For the years ended December 31, 2003, 2004, 2005, 2006 and 2007,
we have not declared or paid any dividends on our common shares.
Material Contracts
Supply Agreements and
Distribution Agreements
On October 25, 1995, Frosst Radiopharmaceuticals, a division of
Merck Frosst Canada Inc. (now known as DRAXIMAGE) entered into a non-exclusive
distribution agreement with Syncor International Corporation (now known as
Cardinal Health 414, LLC) for distribution in the U.S. of DTPA, a kit used to
prepare Tc-99m Pentetate to study kidney clearance, and MDP, a kit used to
prepare Tc-99m Methylene Diphosphonic Acid to study bone metabolism. The initial term was for five years, with automatic
renewal of the agreement for successive two-year periods unless a party
notifies the other of its intent to renew at least one year prior to the
expiration of the renewal term.
On July 12, 2000 DRAXIMAGE signed a non-exclusive distribution
agreement with Syncor International Corporation (now known as Cardinal Health
414, LLC) for the production of a kit for the preparation of Sodium Iodide
I-131 Capsules and Oral Solution indicated for the treatment of thyroid cancer
and hyperthyroidism for sale in the U.S.
The term of the agreement is five years from the date DRAXIMAGE makes
the first sale of the product. The date
of the first sale was March 2003.
This agreement was amended on August 6, 2003 to provide that
DRAXIMAGE could distribute the product to independent radiopharmacies in the
U.S. The contract is renewed
automatically for three year terms, unless a notice of non renewal is received
at least six months prior to the expiration of a renewal term. As of March 31, 2008, no such notice has
been received.
On July 1, 1999, DRAXIS Pharma entered into a five-year
manufacturing and supply agreement with Warner-Lambert Canada Inc. (which then
became known as Pfizer Consumer Healthcare, a division of Pfizer Canada Inc.)
covering several non prescription products for the Canadian market, including
Polysporin
Ò
, Sudafed
Ò
, Actifed
Ò
and Zincofax
Ò
. Manufacturing of these products commenced in
early 2000. On September 1, 2005,
DRAXIS Pharma announced it had renewed its agreement with Pfizer Canada for a
three year term effective January 1, 2005.
On December 20, 2006, DRAXIS Pharma was advised that J&J had
purchased Pfizers consumer healthcare business and that the agreement was
assigned to J&J. The Agreement was
subsequently renewed for a one year period ending December 31, 2008.
On December 18, 2001, DRAXIS Pharma finalized supply and related
agreements with GSK for the renewal and expansion of an existing contract
manufacturing relationship between the companies. The products transferred to DRAXIS Pharma
were all established, sterile products marketed by GSK in multiple
international markets. In 2002, a
prescription sterile injectable product for the U.S. market was added under
this contract and commercial production of this product commenced in the second
quarter of 2002. During 2002, site
transfer and related activities associated with the other GSK products
continued and production started in the second quarter of 2003 and ramped up
through 2003 and 2004 with full production achieved by the end of 2004. DRAXIS Pharma shall manufacture the products
covered by the agreement until it receives a termination notice from GSK which
may be given by a two-year advance written notice given on or after December 31,
2007. As of March 31, 2008, the
Company has not received any such notice.
On March 3, 2003, DRAXIS Pharma signed a manufacturing agreement
with Bone Care International, Inc. (now Genzyme Corporation) to produce
Hectorol
Ò
Injection for
sale in the U.S. and
117
began commercial shipments of the sterile
injectable product in March 2003.
Production of Hectorol
Ò
Injection increased
substantially throughout 2005. The
agreement is for a five-year term and is automatically renewed at the end of
its term for one year period unless either party gives written notice of non
renewal to the other party one year prior to the end of the term or the end of
a renewal period. To date, the Company
has not received any such notice.
On June 10, 2004, the Company entered into an Amended and Restated
Loan Agreement with the National Bank of Canada providing an operating facility
of CDN$15 million (or U.S. equivalent), payable within 364 days of drawing upon
the facility and a term facility of CDN$10 million (or U.S. equivalent),
repayable in full in three years. The
operating facility can be extended by one year upon agreement with the
bank. Interest under both the term and
operating facilities is based on the banks prime lending rate, depending on
whether the Company meets certain ratios which as at December 31, 2006
were met. This agreement was not renewed
at its termination on June 9, 2007.
On July 22,
2003, the Company entered into an Asset Purchase Agreement with Shire BioChem
Inc., pursuant to which the Company sold Shire the rights to substantially all
remaining products of its Canadian pharmaceutical sales and marketing division,
DRAXIS Pharmaceutica, in return for $9.6 million (CDN$13.5 million) in cash and
up to an additional $2.9 million (CDN$4.0 million) in market-driven contingent
milestone payments, plus royalties on future product sales. Under the terms of the agreement, DRAXIS
received the value of acquired inventories, and Shire assumed responsibility
for the financial provisions of the license agreement related to Permax®.
On September 4,
2007, the Company entered into a new definitive supply agreement with Johnson &
Johnson Consumer Companies to provide commercial manufacturing services for a
broad portfolio of multiple non-sterile specialty semi-solid products currently
marketed in the United States. This new
multi-year contract runs to the end of 2013. It includes approximately two
years of manufacturing site transfer and process validation activities followed
by five years of commercial production, which is scheduled to begin in 2009.
Commercial production is expected to generate incremental revenues in excess of
$120 million over the five year period of 2009 through 2013. A copy of the supply agreement is filed as Exhibit 4.68
to this Annual Report (Form 20-F).
In connection with
the supply agreement with JJC, DRAXIS Pharma also signed a credit agreement
with Johnson & Johnson Finance Corporation (JJFC) as of September 4,
2007 which provides that JJFC shall provide credit facilities of up to $12.2
million. The credit facilities will be
used by DRAXIS Pharma solely to finance the acquisition and installation of
equipment and to finance the cost of transfer of the technology required for
the pre-validation work in support of the manufacture by DRAXIS Pharma of the
products under the supply agreement. A
copy of the credit agreement is filed as Exhibit 4.69 to this Annual
Report (Form 20-F).
On December 20,
2007, DRAXIMAGE, DRAXIS radiopharmaceutical division, entered into a
distribution agreement with GE Healthcare, an industry leader in nuclear
medicine, as the exclusive distributor of DRAXIMAGE
®
Sestamibi in
the United States. DRAXIMAGE
®
Sestamibi is a generic kit for the
preparation of Technetium (Tc-99m) Sestamibi injection, a diagnostic cardiac
imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood
flow to the heart. DRAXIMAGE has granted
GE Healthcare the exclusive right to market, distribute and sell its generic
DRAXIMAGE
®
Sestamibi in the U.S. market and through its U.S. and
Canadian radiopharmacy network once the primary innovator patent expires and
marketing authorizations are received from the U.S. Food and Drug
Administration (FDA) and Health Canada. Furthermore, GE Healthcare has agreed
to purchase Technetium Tc-99m Sestamibi injection exclusively from DRAXIMAGE.
The initial term of the distribution agreement is for a minimum of three years
following FDA approval of
DRAXIMAGE
Ò
118
Sestamibi
. A copy of the distribution agreement is filed
as Exhibit 4.70 to this Annual Report (Form 20-F).
Employment and Employment related Agreements
On September 24, 2003,
the Company, upon the recommendation of the Human Resources and Compensation
Committee, entered into a Retirement Compensation Agreement (RCA) with Dr. Barkin
to phase out the liability of the Company under the termination without cause
provisions of his employment agreement.
The RCA called for the Company to make payments totalling CDN$1.4
million to Dr. Barkin. All of the
required payments were made.
In April 2003, the Company entered into an employment agreement
with Mr. Durham, pursuant to which Mr. Durham agreed to be employed
as the President of DRAXIS Pharma Inc. (now known as DRAXIS Pharma, a division
of DRAXIS Specialty Pharmaceuticals Inc.).
In the event that Mr. Durham is terminated without cause, he would
be entitled to receive a payment equal to one year of base salary. In the event that Mr. Durham is
terminated without cause following a defined change of control, he would be
entitled to receive a payment equal to two years of base salary. Mr. Durham ceased being an employee of
the Company on July 20, 2007.
In October 2003, the Company entered into an employment agreement
with Ms. Gualtieri, pursuant to which Ms. Gualtieri agreed to be
employed as General Counsel and Corporate Secretary of DRAXIS. In the event that Ms. Gualtieri is
terminated without cause, she would be entitled to receive a payment equal to
one year of base salary. In the event
that Ms. Gualtieri is terminated without cause following a defined change
of control, she would be entitled to receive a payment equal to two years of
base salary.
In March 2004, the Company entered into an employment agreement
with Mr. Huang, pursuant to which Mr. Huang agreed to be employed as
Vice President Finance of DRAXIS. In the
event that Mr. Huang is terminated without cause, he would be entitled to
receive a payment equal to one year of base salary. In the event that Mr. Huang is terminated
without cause following a defined change of control, he would be entitled to
receive a payment equal to two years of annual remuneration. Mr. Huang will cease to be employed by
the Company as of March 31, 2008.
In March 2004, the Company entered into an employment agreement
with Mr. Oleksiw, pursuant to which Mr. Oleksiw agreed to be employed
as Chief Financial Officer of DRAXIS. In
the event that Mr. Oleksiw is terminated without cause, he would be
entitled to receive a payment equal to one year of base salary. In the event that Mr. Oleksiw is
terminated without cause following a defined change of control, he would be
entitled to receive a payment equal to two years of annual remuneration.
In March 2004, in order to conform with the terms of the Stock
Option Plan approved by the shareholders of the Company in 2001, the Company
entered into amended employment agreements with Mr. Carter, Mr. Durham,
Ms. Gualtieri and Mr. Ormiston.
Under the terms of the amended employment agreements, in the event of termination
of employment without cause following a defined change of control of the
Company, Mr. Carter, Mr. Durham, Ms. Gualtieri and Mr. Ormiston,
as the case may be, would be entitled to exercise all stock options and other
securities, including those not then otherwise exercisable. Mr. Durham ceased being an employee of
the Company on July 20, 2007. In
addition, under the terms of the amended employment agreement, Ms. Gualtieri
is entitled, in the event of a termination without cause following a defined
change of control, to receive a payment equal to two years annual remuneration.
119
In November 2007, Mr. Carters employment agreement was
amended so that he ceased to be an officer of the Company and to provide that
he was no longer entitled to any payment in the event of a termination of his
employment following a defined change of control.
On July 8, 2005,
the Company, upon the recommendation of the Human
Resources and Compensation Committee, entered into an agreement with Dr. Flanagan
with respect to the payment of his long term incentive award under the
DRAXIMAGE Long Term Incentive Plan by entering into a Retirement Compensation
Agreement (RCA) in his favour for a total amount of CDN$2.2 million. The RCA called for the Company to make
payments totalling CDN$2.2 million to Dr. Flanagan. An amount of CDN$932,222 was paid in 2005, an
amount of CDN$724,444 was paid in 2006 and an amount of CDN$543,333 was paid in
2007. No sum remains outstanding under
the RCA. Dr. Flanagan ceased to be
an employee of the Company on December 31, 2006.
In January 2008, the employment agreements of each of Ms. Gualtieri,
Mr. Oleksiw and Mr. Ormiston were modified so that in the event of a
termination of their employment following a defined change of control event,
each of these employees would be entitled to receive
a payment equal to: (i) two
(2) times his or her base salary, and (ii) two (2) times the
amount paid as a discretionary bonus for the preceding calendar year
immediately prior to the change of control and, if no such bonus was made for
the preceding year, a payment equal to two (2) times the prorated portion
of any eligible bonus payment up to the date of termination, and (iii) two
(2) times the prorated portion of his or her RRSP payment, and (iv) six
(6) months coverage in the Companys benefit plans. A copy of each of the amendments to the
employment agreements for Ms. Gualtieri, Mr. Oleksiw and Mr. Ormiston
are filed as Exhibit 4.71, 4.72 and 4.73 to this Annual Report (Form 20-F).
In February 2008, the Company entered into an employment contract
with Mr. Brazier following his appointment as President and Chief
Executive Officer of the Company. The
contract is not for a fixed period of time.
In the event of a termination of his employment without cause which is
not due to a defined change of control event, Mr. Brazier is entitled to
receive a payment equal to (i) eighteen (18) months of his base salary,
and (ii) a prorated portion of any eligible bonus payment up to the date
of termination, and (iii) a prorated portion of the RRSP payment, and (iv) six
(6) months coverage in the Companys benefit plans. In the event of a termination of his
employment without cause following a defined change of control of the Company, Mr. Brazier
is entitled to receive a payment equal to (i) three (3) times his
base salary, and (ii) three (3) times the amount paid as a
discretionary bonus for the preceding calendar year immediately prior to the
change of control, and (iii) three (3) times the prorated portion of
the RRSP payment, and (iv) six (6) months coverage in the Companys
benefit plan.
A copy of the employment
agreement is filed as Exhibit 4.74 to this Annual Report (Form 20-F).
In March 2008, the Company entered into an employment contract with
Mr. Robert following his appointment as Chief Operating Officer of the
Company. The contract is not for a fixed
period of time. In the event of a
termination of his employment without serious reason which is not due to a
defined change of control event,
Mr. Robert is entitled to receive a payment equal
to one (1) year of base salary if the termination is on or prior to December 31,
2008 and one (1) year of base salary plus an amount equal to the bonus
payment if any was received in proceeding calendar year, if the termination is
on January 1, 2009 or thereafter.
In addition, Mr. Robert is entitled to receive a prorated portion
of his RRSP payment and six (6) months coverage in the Companys benefit
plans. In the event of a termination of
his employment without serious reason following a defined change of control of
the Company, Mr. Robert is entitled to receive a payment equal to: (i) two
(2) times his base salary, and (ii) two (2) times his RRSP
payment, and (iii) six (6) months coverage in the Companys benefit
plans. A copy of the employment
agreement is filed as Exhibit 4.75 to this Annual Report (Form 20-F).
120
In March 2008,
the employment agreement of Ms. Gualtieri was modified so that her
discretionary bonus entitlement was increased to 40% from 30% effective January 1,
2008.
A copy of the amendment to the employment
agreement is filed as Exhibit 4.76 to this Annual Report (Form 20-F).
Exchange Controls
Canada has no system of exchange controls. There are no exchange restrictions on
borrowing from foreign countries or on the remittance of dividends, interest,
royalties and similar payments, management fees, loan repayments, settlement of
trade debts or the repatriation of capital.
There are no limits on the rights of non-Canadians to exercise voting
rights on their common shares of the Company.
Canadian Federal Income Tax
Considerations
The following summary describes the principal Canadian federal income
tax considerations generally applicable under the Income Tax Act (Canada) (the
ITA) to a holder of the Companys common shares (Shares) who holds such
Shares as capital property and who deals at arms length, and is not
affiliated, with the Company, all within the meaning of the ITA. Generally, the Shares will be considered to
be capital property to a holder provided that the holder does not use or hold,
and is not deemed to use or hold, the Shares in the course of carrying on a
business or as part of an adventure or concern in the nature of trade.
Certain holders resident in Canada whose Shares might
not othe
rwise qualify as capital property may be entitled to
make an irrevocable election in accordance w
ith subsection 39(4) of the ITA to
have such Shares and any other Canadian security (as defined in the ITA)
treated as capital property in the taxation year of the election and in all
subsequent taxation years. Holders
considering such an election should consult their tax advisors. Certain holders, including financial
institutions, registered securities dealers (each as defined in the ITA) and
corporations controlled by one or more of the foregoing, are generally
precluded from treating the Shares as capital property.
This summary is not applicable to financial institutions (as defined
in the ITA) that are subject to the mark-to-market rules in the ITA, to
a specified financial institution (as defined in the ITA), to a holder an
interest in which is a tax shelter investment (as defined in the ITA), or to
a holder to which the functional currency reporting rules in subsection
261(4) of the ITA apply. Such
holders
should
consult their own tax advisors
. Persons to whom this summary is applicable
are referred to herein as Holders.
This summary is based on the provisions of the ITA and the regulations
thereunder (the Regulations) in force on the date hereof and the Companys
understanding of the current administrative policies and practices published in
writing by the Canada Revenue Agency (CRA) prior to the date hereof. This summary takes into account all specific
proposals to amend the ITA and the Regulations which have been publicly
announced by or on behalf of the Minister of Finance (Canada) prior to the date
hereof (the Proposed Amendments) and assumes that all such Proposed
Amendments will be enacted in their present form. No assurance can be given that the Proposed
Amendments will be enacted in the form proposed, if at all. This summary does not otherwise take into
account or anticipate any changes
to the law, whether by judicial, governmental or
legislative decision or action or changes in the administrative policies and
practices of the CRA, nor does it take into account provincial, territorial or
foreign income tax legislation or considerations which may differ materially
from those described in this summary.
This summary is of a general nature only and is
not exhaustive of all possible Canadian federal income tax considerations and
is not intended to be, nor should it be construed to be, legal, business or tax
advice or representations to any particular holder. Accordingly, holders should consult their own
tax advisors with respect to the tax consequences to them of selling Shares
under
121
the Offer, having regard to their
particular circumstances, including the application and effect of the income
and other tax laws of any country, province, territory, state or local tax
authority.
All
amounts relating to the acquisition, holding or disposition of Shares,
including dividends, adjusted cost base and proceeds of disposition, must be
expressed in Canadian dollars as determined in accordance with the rules in
the ITA, including subsection 261(2).
Shareholders Not Resident in Canada
The following portion of the summary generally is
applicable to a Holder of the Companys Shares who, at all relevant times and
for the purposes of the ITA and any applicable tax treaty or convention, is
not, and is not deemed to be, resident in Canada, does not hold or use and is
not deemed to hold or use such Shares in connection with, or in the course of
carrying on a business in Canada, is not an insurer that carries on an
insurance business in Canada and elsewhere and is not an authorized foreign
bank. Such non-resident holders of
Shares to whom this summary is applicable are referred to herein as
Non-Resident Holders.
Dividends Non-Resident
Holders
Dividends, including stock and cash dividends and certain distributions
and redemptions deemed to be dividends under the ITA, on the Shares paid or
credited or deemed to be paid or credited to a Non-Resident Holder will be
subject to Canadian withholding tax at a rate of 25%. The applicable rate of withholding may,
however, be reduced by virtue of the terms of any applicable tax treaty. Under the Canada-United States Income Tax
Convention, 1980 (the US Treaty), the rate applicable to Non-Resident Holders
that are United States residents who are beneficial owners of Shares is
generally 15%. Under the US Treaty,
certain tax-exempt entities that are resident in the United States may be
exempt from Canadian withholding tax levied in respect of dividends paid on the
Shares. Such tax-exempt entities should
consult their own tax advisors. A
Non-Resident Holder should also consult its own tax advisors regarding its
ability to claim foreign tax credits with respect to any Canadian withholding
tax.
Dispositions by Non-Resident
Holders
A Non-Resident Holder will not be subject to tax under
the ITA in respect of any capital gain realized as a consequence of a
disposition or deemed disposition of Shares (other than to the Company), except
to the extent that such shares constitute or are deemed to constitute taxable
Canadian property (TCP) (as defined in the ITA) and the Non-Resident Holder
is not otherwise entitled to relief under the terms of any applicable tax
treaty. Under the US Treaty, a capital
gain realized by a Non-Resident Holder that is a resident of the United States
for such purposes will not be subject to Canadian tax, provided that the value
of the Shares is not derived principally from real property (as defined in the
US Treaty) situated in Canada.
In general, provided the Shares are listed on a
designated stock exchange (which currently includes the TSX), the Shares will
not constitute TCP of a Non-Resident Holder so long as it has not, either alone
or in combination with persons with whom the Holder does not deal at arms length,
owned (or had an option to acquire) 25% or more of the issued shares of any
class or series of the capital stock of the Company at any time within the 60
month period preceding the disposition.
122
Shareholders Resident in Canada
The following portion of the summary generally is applicable to a
Holder who, at all relevant times and for purposes of the ITA and any
applicable tax treaty or convention, is, or is deemed to be, resident in Canada
(a Canadian Holder).
Dividends to Canadian Holders
Dividends, including stock and cash dividends and
certain distributions and redemptions deemed to be dividends under the ITA, on
the Shares paid to a Canadian Holder will be included in computing its income
for purposes of the ITA. Such dividends
received or deemed to be received by an individual (other than a trust) will
generally be subject to the gross-up and dividend tax credit rules normally
applicable to taxable dividends received from taxable Canadian corporations. An enhanced dividend tax credit is applicable
to certain eligible dividends received after 2005 from certain taxable
Canadian corporations. A dividend will
be eligible for the enhanced dividend tax credit if the individual Canadian
Holder receives notice from the Company designating the dividend as an
eligible dividend. Dividends received
or deemed to be received on Shares by an individual and certain trusts may give
rise to alternative minimum tax.
Generally, dividends received or deemed to be received
on Shares by a Holder that is a corporation resident in Canada will be included
in computing the corporations income, but will be deductible in computing the
corporations taxable income, subject to certain limitations in the ITA. To the extent that such a deduction is
available, private corporations (as defined in the ITA) and certain other
corporations may be liable to pay refundable tax under Part IV of the ITA
at a rate of 33 1/3% on the amount of the dividend. Subsection 55(2) of the ITA provides
that where certain corporate holders of shares receive a dividend or deemed
dividend in specified circumstances, all or part of such dividend may be
treated as a capital gain from the disposition of capital property and not as a
dividend. Corporate Canadian Holders
should consult their tax advisors concerning the potential application of
subsection 55(2).
Disposition by Canadian
Holders
On a disposition or deemed disposition of a Share a
Canadian Holder will realize a capital gain (or capital loss) equal to the
amount by which the proceeds of disposition for the Share exceed (or are less
than) the aggregate of the adjusted cost base (determined in accordance with
the ITA) to the Holder of the Share immediately before the disposition and any
reasonable costs of disposition.
Generally, one-half of any such capital gain (a
taxable capital gain) must be included in computing the Holders income in
the year of disposition and one half of any such capital loss (an allowable
capital loss) will be required to be deducted from taxable capital gains
realized by the Holder in such year.
Allowable capital losses not deducted in the taxation year in which they
are realized may generally be carried back to any of the three preceding
taxation years or carried forward to any future taxation year and deducted
against net taxable capital gains realized in such years, to the extent and
under the circumstances described in the ITA.
The amount of any capital loss realized by a Holder
that is a corporation on the disposition of a Share may be reduced by the
amount of dividends received or deemed to be received by it on such Share to
the extent and under the circumstances prescribed by the ITA. Similar rules apply to a partnership or
trust of which a corporation, trust or partnership is a member or beneficiary.
A Canadian Holder that is a Canadian-controlled
private corporation throughout the year (as defined in the ITA) may be liable
to pay an additional refundable tax of 6 2/3% on any taxable capital gains.
123
Capital gains realized by an individual or certain
trusts may give rise to a liability for alternative minimum tax.
Documents on Display
We are subject to
the information requirements of the U.S. Securities Exchange Act of 1934, as
amended. In accordance with these
requirements, we file reports and other information with the United States
Securities and Exchange Commission. These
materials, including this Annual Report (Form 20-F) and the exhibits thereto,
may be inspected and copied at the Commissions Public Reference Room at
100 F Street, N.E., Washington, D.C. 20549 and at the Commissions regional
offices at 500 West Madison Street, Suite 1400, Chicago, Illinois
60661. Copies of the materials may be
obtained from the Public Reference Room of the Commission at 100 F Street,
N.E., Washington, D.C. 20549 at prescribed rates. The public may obtain information on the
operation of the Commissions Public Reference Room by calling the
Commission in the United States at 1-800-SEC-0330. The Commission also maintains a website at
www.sec.gov that contains reports, proxy statements and other information
regarding registrants that file electronically with the Commission. The Companys annual reports and some of the
other information submitted by the Company to the Commission may be accessed
through this website. In addition,
material filed by the Company can be inspected at the offices of the NASDAQ at
9801 Washingtonian Blvd., Gaithersburg, MD 20878, and on the Canadian
Securities Administrators electronic filing system, SEDAR, accessible at the
website www.sedar.com. This material
includes the Companys Management Information Circular for its annual meeting
to be held on May 15, 2008, which provides information including
directors and officers, remuneration and indebtedness, principal holders of
securities and securities authorized for issuance under equity compensation
plans. Additional financial information
is provided in our annual financial statements for the year ended December 31,
2007 and our Managements Discussion and Analysis relating to these
statements. These documents are also
accessible on SEDAR (www.sedar.com).
Item 11. Quantitative and Qualitative
Disclosures About Market Risk
Market Risk
We are exposed to financial market risks, including
changes in foreign currency exchange rates and interest rates on
investments. We do not use derivative
financial instruments for speculative or trading purposes.
Inflation has not had a significant impact on our results of operations.
Foreign Currency Risk
Our reporting currency is the U.S. dollar. The functional currency for our Canadian
operations, which includes the radiopharmaceutical segment, contract
manufacturing segment and royalties and milestones related to product rights
sold to Shire, is the Canadian dollar.
Accordingly, our foreign exchange exposure for accounting purposes
mainly relates to U.S.-denominated monetary assets of these operations. We do not currently use derivative instruments
to hedge our foreign exchange risk and currently have no plans to do so in the
near future. For fiscal year 2007, U.S.
dollar revenue accounted for approximately 51% of the Companys revenue. During this same period, the value of the
Canadian dollar versus the U.S. dollar strengthened by 18% from January 1,
2007 to December 31, 2007. As a
result, in 2007 we had to charge to income $1.7 million of foreign exchange
loss related to the strengthening of the Canadian dollar. See Risk Factors Risks Related to Our
Company We are Exposed to Exchange Rate Fluctuations which could Negatively
Affect our Business.
124
Interest Rate Risk
The
primary objective of our investment policy is the protection of principal, and
accordingly we invest in high-grade commercial paper and government securities
with varying maturities, but typically less than 90 days. As it is our intent and policy to hold these
investments until maturity, we believe we do not have a material exposure to
interest rate risk.
We currently have no outstanding third party debt, but we do have
access to undrawn credit facilities with variable interest rates. Should we borrow in the future on our
existing facilities, any material changes to interest rates could result in
materially increased interest expense and decreased results of operations.
Item 12. Description of Securities Other Than Equity
Securities
Not Applicable
PART II.
Item 13. Defaults, Dividends Arrearages and Delinquencies
None
Item 14. Material Modifications to the Rights of Security
Holders and Use of Proceeds
None
Item 15 Controls and Procedures
A.
Disclosure Controls and Procedures
As at the end of
the period covered by this report, our Chief Executive Officer and our Chief
Financial Officer, together with members of our senior management, have carried
out an evaluation of the effectiveness of the design and operation of our
disclosure controls and procedures.
These are defined (in Rule 13a-15(e) or 15d-15(e) under
the Securities Exchange Act of 1934, as amended) as those controls and
procedures designed to ensure that information required to be disclosed in
reports filed under the United States Securities Exchange Act of 1934, as
amended, is recorded, processed, summarized and reported within specified time
periods. As of the date of the
evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that the design and operation of these disclosure controls and procedures were
effective to provide reasonable assurance that information required to be
disclosed by us in the reports that we file or submit under the United States
Securities Exchange Act of 1934, as amended, is recorded, processed, summarized
and reported, within the time periods specified in the applicable rules and
forms, and that it is accumulated and communicated to our management, including
our Chief Executive Officer and Chief Financial Officer, as appropriate to
allow timely decisions regarding required disclosures.
B.
Managements Annual
Report on Internal Control over Financial Reporting
Our management is
responsible for establishing and maintaining adequate internal control over
financial reporting for the Company. Internal control over financial reporting
is a process designed to provide reasonable assurance regarding the reliability
of our financial reporting for external purposes in accordance with accounting
principles generally accepted in the United States of America. Internal control
over financial reporting includes maintaining records that in reasonable detail
accurately and fairly reflect the transactions and disposition of our assets;
providing reasonable assurance that
125
transactions are recorded as necessary for preparation of our financial
statements; providing reasonable assurance that receipts and expenditures of
the Company are made in accordance with management authorization; and providing
reasonable assurance that unauthorized acquisition, use or disposition of
Company assets that could have a material effect on our financial statements
would be prevented or detected on a timely basis. Because of its inherent
limitations, internal control over financial reporting is not intended to
provide absolute assurance that a misstatement of our financial statements
would be prevented or detected. Also,
projections of any evaluation of effectiveness to future periods are subject to
the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may
deteriorate.
Management
conducted an evaluation of the effectiveness of our internal control over
financial reporting based on the framework in
Internal
Control - Integrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Based on this evaluation, management
concluded that the Companys internal control over financial reporting was
effective as of December 31, 2007.
There was no
change during the fiscal year ended December 31, 2007 that has materially
affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
Deloitte &
Touche LLP, Independent Registered Chartered Accountants, have issued an audit
opinion on the effectiveness of the Companys internal control over financial
reporting as of December 31, 2007, as stated in their report appearing
below.
C.
Attestation Report of the Registered
Public Accounting Firm
To the
Shareholders and Board of Directors of DRAXIS Health Inc.
We have
audited the internal control over financial reporting of DRAXIS Health Inc. and
subsidiaries (the Company) as of December 31, 2007, based on the
criteria established in
Internal
ControlIntegrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission. The Companys management is
responsible for maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control over financial
reporting, included in the accompanying Managements Report on Internal Control
over Financial Reporting. Our responsibility is to express an opinion on the
effectiveness of the Companys internal control over financial reporting based
on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan and perform the audit to obtain reasonable assurance about whether
effective internal control over financial reporting was maintained in all
material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness
exists, testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk, and performing such other procedures as we
considered necessary in the circumstances. We believe that our audit provides a
reasonable basis for our opinion.
A
companys internal control over financial reporting is a process designed by,
or under the supervision of, the companys principal executive and principal
financial officers, or persons performing similar functions, and effected by
the companys board of directors, management, and other personnel to provide reasonable
assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally
accepted accounting principles. A companys internal control over financial
reporting includes those policies and procedures that (1) pertain
126
to the maintenance of records that, in reasonable
detail, accurately and fairly reflect the transactions and dispositions of the
assets of the company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial statements in
accordance with generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with
authorizations of management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a
material effect on the financial statements.
Because
of the inherent limitations of internal control over financial reporting,
including the possibility of collusion or improper management override of
controls, material misstatements due to error or fraud may not be prevented or
detected on a timely basis. Also, projections of any evaluation of the
effectiveness of the internal control over financial reporting to future
periods are subject to the risk that the controls may become inadequate because
of changes in conditions, or that the degree of compliance with the policies or
procedures may deteriorate.
In our
opinion, the Company maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2007, based on the
criteria established in
Internal Control
Integrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission.
We have
also audited, in accordance with Canadian generally accepted auditing standards
and with the standards of the Public Company Accounting Oversight Board (United
States), the consolidated financial statements as of and for the year ended December 31,
2007 of the Company and our report dated February 22, 2008 expressed an
unqualified opinion on those financial statements and included a separate
report titled
Comments by Independent Registered Chartered
Accountants on Canada-United States of America Reporting Differences
referring to changes in accounting principles.
DELOITTE & TOUCHE LLP
Montréal, Québec, February 22, 2008
This report is included in the
Financial Statements under Report of Independent Registered Chartered
Accountants on Page F-3.
D.
Changes in Internal Control Over
Financial Reporting
There have
occurred no changes in our internal control over financial reporting (as
defined in Rule 13a-15 or 15d-15 under the Exchange Act) during the period
covered by this Annual Report (Form 20-F) that have materially affected,
or are reasonably likely to materially affect, our internal control over
financial reporting.
The information
furnished pursuant to Item 15T of this Annual Report (Form 20-F) shall not
be deemed filed for purposes of the Securities Exchange Act of 1934, as
amended, nor shall it be incorporated by reference into any of the Companys
filings under the Securities Act of 1933, as amended, unless otherwise
expressly stated in such filing.
Item 16A.
Audit Committee Financial Expert
127
The Companys
Board of Directors has determined that Mr. Rolf Henel, a member of the
Companys Audit Committee, is a financial expert. Mr. Henel is an independent director
under each of definitions of such terms under the applicable Canadian, TSX,
U.S. and NASDAQ rules.
Item 16B. Code of Ethics and Business Conduct
In April 2004, we amended our existing Code of Ethics, which
resulted in the establishment of a new Code of Ethics and Business Conduct (the
Code) in light of our continued commitment to honesty and integrity in the
conduct of its business. The Code
applies to all our directors, officers and employees, including our Chief
Executive Officer, our Chief Financial Officer and all employees of our
subsidiaries. The Code is available on
our website at www.draxis.com and was filed on SEDAR (www.sedar.com) on August 31,
2005. In addition, upon written request,
we can provide a copy of the Code.
In accordance with the terms of the Code, the Audit Committee receives
quarterly reports from the Director of Human Resources on any concerns raised
regarding accounting, internal accounting controls and auditing matters. The Board of Directors monitors compliance
with the Code by receiving quarterly reports from the Audit Committee regarding
any concerns raised. Complaints received
by any officer concerning any violation of the Code are brought to the
attention of the Board of Directors. The
Code is distributed and signed by each of the Companys employees when they are
hired and it is available on the Companys intranet and in each employee
handbook. Information sessions are given
to employees on the contents and application of the Code.
If we amend any provisions of our Code or if we grant any waiver of
such provisions, we will disclose such amendment or waiver on our web site at
the same address www.draxis.com.
Item 16C. Principal Accountant Fees and Services
In accordance with the Audit Committee Charter, the Audit Committee
pre-approves all auditing services and permitted non-audit services (including
fees and terms thereof) to be performed for the Company or its subsidiaries by
its Independent Registered Chartered Accountants. All the services of Deloitte &
Touche LLP rendered in 2007 were pre-approved by the Audit Committee.
Deloitte & Touche LLP, Independent Registered Chartered
Accountants (Companys auditor or Companys principal accountant) has
served as our Independent Registered Chartered Accountants for each of the
fiscal years in the three-year period ended December 31, 2007, for which
audited financial statements appear in this Annual Report (Form 20-F).
2007 Audit Fees
The fees for all audit services performed by the Companys auditor and its
subsidiaries for the year ended December 31, 2007 were CDN$446,100.
Services provided include the audit of the Companys consolidated financial
statements, review of the notes to the annual report to shareholders,
management proxy circular, quarterly reviews, this Annual Report (Form 20-F)
and attestation of the effectiveness of the Companys internal control over
financial reporting. No hours were expended
in the audit of our financial statements by persons other than the Companys
principal accountant.
2007 Audit-Related
Fees
The aggregate fees billed for the year ended December 31, 2007 for
assurance and related services by the Companys auditor that are reasonably
related to the performance of the audit or review of the Companys financial
statements were CDN$Nil.
128
2007 Tax Fees
The aggregate fees billed for the year ended December 31, 2007 for
professional services rendered by the Companys auditor for tax compliance, tax
advice and tax planning were CDN$42,810.
2007 All Other Fees
The aggregate fees billed for the year ended December 31, 2007 for
products and services provided by the Companys auditor, other than those
described above, were CDN$Nil.
2006 Audit Fees
The fees for all audit services performed by the Companys auditor and its
subsidiaries for the year ended December 31, 2006 were CDN$315,500.
Services provided include the audit of the Companys consolidated financial
statements, review of the notes to the annual report to shareholders,
management proxy circular, quarterly reviews and this Annual Report (Form 20-F). No hours were expended in the audit of our
financial statements by persons other than the Companys principal accountant.
2006 Audit-Related
Fees
The aggregate fees billed for the year ended December 31, 2006 for
assurance and related services by the Companys auditor that are reasonably
related to the performance of the audit or review of the Companys financial
statements were CDN$Nil.
2006 Tax Fees
The aggregate fees billed for the year ended December 31, 2006 for
professional services rendered by the Companys auditor for tax compliance, tax
advice and tax planning were CDN$39,750.
2006 All Other Fees
The aggregate fees billed for the year ended December 31, 2006 for
products and services provided by the Companys auditor, other than those
described above, were $Nil.
Interest of Auditors
Deloitte &
Touche LLP are the Independent Registered Chartered Accountants of the Company
and are independent within the meaning of the Code of Ethics of the Ordre des
comptables agréés du Québec, and of the Securities Act of 1933 and the
applicable rules and regulations thereunder adopted by the Securities and
Exchange Commission (SEC) and the Public Company Accounting Oversight Board
(United States).
Item 16D. Exemptions from the Listing Standards for Audit
Committees
Not
applicable.
Item 16E. Purchases of Equity Securities by the Issuer and
Affiliated Purchasers
On November 1, 2006,
the Board of Directors authorized the purchase of up to 10% of the public float
of the Companys common shares through a Normal Course Issuer Bid (the 2006
Issuer Bid) to be commenced on December 20, 2006. Pursuant to the acceptance by the TSX, on December 18,
2006, of
129
the Notice of Intention to
make the 2006 Issuer Bid, the Company was authorized to purchase on the open
market through the facilities of the Toronto Stock Exchange up to 3,397,011
common shares for cancellation, representing 10% of the 33,970,112 common
shares in the public float as at December 14, 2006. The Company purchased 130,100 common shares
under the 2006 Issuer Bid, which terminated on December 19, 2007.
On January 7, 2008, the
Board of Directors authorized the purchase of up to 10% of the public float of
the Companys common shares through a Normal Course Issuer Bid (the 2008
Issuer Bid) to be commenced on January 21, 2008. The 2008 Issuer Bid enables the Company to
purchase on the open market through the facilities of the Toronto Stock
Exchange up to 4,072,054 common shares for cancellation, representing 10% of
the 40,720,539 common shares in the public float as at January 14,
2008. Pursuant to the acceptance by the
Toronto Stock Exchange, on January 16, 2008, of the Notice of Intention to
make a Normal Course Issuer Bid, the Company was authorized to purchase common
shares under the 2008 Issuer Bid commencing on January 21, 2008 until January 20,
2009, or until such earlier date when the Company purchases the maximum
allowable number of shares or elects to terminate the 2008 Issuer Bid. Subject to any block purchases made in
accordance with the rules of the Toronto Stock Exchange, the Company is
subject to a daily repurchase restriction of 23,084 common shares, which
represents 25% of the average daily trading volume of the Companys common
shares on the Toronto Stock Exchange for the six (6) months ended December 31,
2007. As of March 18, 2008, the
Company had not purchased any common shares under the 2008 Issuer Bid.
130
ISSUER PURCHASES OF EQUITY
SECURITIES
2006 Issuer
Bid
|
|
|
|
|
|
|
|
(d) Maximum
|
|
|
|
|
|
|
|
|
|
Number (or
|
|
|
|
|
|
|
|
|
|
Approximate
|
|
|
|
|
|
|
|
(c) Total Number
|
|
Dollar Value) of
|
|
|
|
|
|
|
|
of Shares (or
|
|
Shares (or Units)
|
|
|
|
|
|
|
|
Units) Purchased
|
|
that May Yet Be
|
|
|
|
(a) Total Number
|
|
(b) Average Price
|
|
as Part of Publicly
|
|
Purchased Under
|
|
|
|
of Shares (Or
|
|
Paid per Share (or
|
|
Announced Plans
|
|
the Plans or
|
|
Period
|
|
Units) Purchased
|
|
Units)
|
|
or Programs
|
|
Programs
|
|
|
|
|
|
|
|
|
|
|
|
December 2006
|
|
|
|
|
|
|
|
3,397,011
|
|
January 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
February 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
March 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
April 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
May 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
June 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
July 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
August 2007
|
|
|
|
|
|
|
|
3,397,011
|
|
September 2007
|
|
12,400
|
|
$5.15 (CDN$5.16)
|
|
12,400
|
|
3,384,611
|
|
October 2007
|
|
117,700
|
|
$5.28 (CDN$5.21)
|
|
130,100
|
|
3,266,911
|
|
November 2007
|
|
|
|
|
|
130,100
|
|
3,266,911
|
|
December 2007
|
|
|
|
|
|
130,100
|
|
3,266,911
|
|
Total
|
|
130,100
|
|
$5.27 (CDN$5.21)
|
|
130,100
|
|
3,266,911
|
|
131
2008 Issuer
Bid
Period
|
|
(a) Total Number
of Shares (Or
Units) Purchased
|
|
(b) Average Price
Paid per Share (or
Units)
|
|
(c) Total Number
of Shares (or
Units) Purchased as
Part of Publicly
Announced Plans
or Programs
|
|
(d) Maximum
Number (or
Approximate
Dollar Value) of
Shares (or Units)
that May Yet Be
Purchased Under
the Plans or
Programs
|
|
|
|
|
|
|
|
|
|
|
|
January 2008
|
|
|
|
|
|
|
|
4,072,054
|
|
February 2008
|
|
|
|
|
|
|
|
4,072,054
|
|
March 2008 (up to March 18, 2008
inclusively)
|
|
|
|
|
|
|
|
4,072,054
|
|
Total
|
|
|
|
|
|
|
|
4,072,054
|
|
PART III.
Item 17. Financial Statements
Not Applicable.
Item 18. Financial Statements
The following financial statements are filed as part
of this Annual Report (Form 20-F).
|
|
|
Managements Report
|
|
F-1
|
Managements Report on
Internal Control over Financial Reporting
|
|
F-2
|
Reports
of Independent Registered Chartered Accountants
|
|
F-3
|
Consolidated Statements
of Operations
|
|
F-5
|
Consolidated Balance
Sheets
|
|
F-6
|
Consolidated Statements
of Changes in Equity and Comprehensive Income (Loss)
|
|
F-7
|
Consolidated Statements
of Cash Flows
|
|
F-8
|
Notes to the
Consolidated Financial Statements
|
|
F-9
|
132
Item 19. Exhibits
Exhibit No.
|
|
Description
|
|
|
|
1.1
|
|
Articles of
Amalgamation of DRAXIS Health Inc. (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2000, filed on June 29, 2001 (SEC file no. 000-17434))
|
1.2
|
|
By-law No. 1 of
DRAXIS Health Inc. (formerly Deprenyl Research Limited) (incorporated herein
by reference to the Companys Annual Report (Form 20-F) for the year
ended December 31, 2000, filed on June 29, 2001 (SEC file no.
000-17434))
|
4.1
|
|
Master Agreement dated
November 12, 1997 among DRAXIS Health Inc., Deprenyl Animal Health Inc.
and Pfizer Inc. (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.2
|
|
License Agreement dated
November 12, 1997 between Deprenyl Animal Health Inc. and Pfizer Inc.
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.3
|
|
Letter Agreement dated
December 22, 1999 between DRAXIS Health Inc., Deprenyl Animal Health
Inc. and Pfizer Inc. (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2000,
filed on June 29, 2001 (SEC file no. 000-17434))
|
4.4
|
|
Second Amendment dated
December 18, 2001 to the Master Agreement, as amended December 22,
1999, License Agreement, Research Agreement, U.S. and Canada Manufacturing
and Supply Agreement and International Manufacturing and Supply Agreement
between Pfizer Inc., Deprenyl Animal Health, Inc. and DRAXIS Health Inc.
dated November 12, 1997 (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2001, filed on May 20, 2002 (SEC file no. 000-17434))
|
4.5
|
|
Amending Agreement
dated March 31, 2003 between DRAXIS Health, Inc., Elan Pharma
International Limited and Elan Pharmaceuticals, Inc. (incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2002, filed on May 14, 2003 (SEC file no.
000-17434))
|
4.6
|
|
First
Amendment to Subscription Agreement dated October 24, 2002 among SGF
Santé Inc., DRAXIS Health Inc. and DRAXIS Pharma Inc. (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2002, filed on May 14, 2003 (SEC file no. 000-17434))
|
4.7
|
|
Share Purchase
Agreement dated April 22, 2004 between DRAXIS Health Inc. and SGF Santé
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.8
|
|
Share Purchase
Agreement dated July 16, 2003 between Mohammed Barkat and DRAXIS Pharma
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.9
|
|
Share Purchase
Agreement dated July 16, 2003 between Michel Sauvageau and DRAXIS Pharma
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
133
4.10
|
|
Term Loan Agreement
dated June 9, 1998 between National Bank of Canada and DRAXIS Pharma
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.11
|
|
Credit Agreement dated
February 18, 2000 between National Bank of Canada and DRAXIS Pharma Inc.
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.12
|
|
Underwriting Agreement
dated April 2, 2004 between DRAXIS Health Inc., Desjardins Securities
Inc. and CIBC World Markets Inc. (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2003, filed on May 14, 2004 (SEC file No. 000-17434))
|
4.13
|
|
Asset
Purchase Agreement dated July 22, 2003 between DRAXIS Health Inc. and
Shire Biochem Inc. (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.14
|
|
Stock Option Plan of
DRAXIS Health Inc., as amended, dated June 27, 2001 (incorporated herein
by reference to the Companys Annual Report (Form 20-F) for the year
ended December 31, 2003, filed on May 14, 2004 (SEC file
No. 000-17434))
|
4.15
|
|
DRAXIS Health Inc.
Employee Stock Ownership Plan, amended and restated, effective
December 1, 1998 (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2000,
filed on June 29, 2001 (SEC file no. 000-17434))
|
4.16
|
|
DRAXIS Health Inc.
Employee Participation Share Purchase Plan, effective February 16, 1995
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.17
|
|
DRAXIS Health Inc.
Deferred Share Unit Plan for Employees (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2000, filed on June 29, 2001 (SEC file no. 000-17434))
|
4.18
|
|
DRAXIS Health Inc.
Equity Purchase Plan (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2000,
filed on June 29, 2001 (SEC file no. 000-17434))
|
4.19
|
|
DRAXIS Retirement
Savings Program (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2002, filed on
May 14, 2003 (SEC file no. 000-17434))
|
4.20
|
|
Shareholder Rights Plan
Agreement dated April 23, 2002 between DRAXIS Health Inc. and
Computershare Trust Company of Canada as trustee (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2001, filed on May 20, 2002 (SEC file no. 000-17434))
|
4.21
|
|
Employment Agreement
dated April 15, 1999 between DRAXIS Health Inc. and Dr. Martin
Barkin (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.22
|
|
Amendment dated
June 14, 2000 to Employment Agreement dated April 15, 1999 between
DRAXIS Health Inc. and Dr. Martin Barkin (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2000, filed on June 29, 2001 (SEC file no. 000-17434))
|
134
4.23
|
|
Retirement Compensation
Agreement dated September 24, 2003 between DRAXIS Health Inc. and
Dr. Martin Barkin (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2003,
filed on May 14, 2004 (SEC file No. 000-17434))
|
4.24
|
|
Employment Agreement
dated April 27, 2004 between DRAXIS Health Inc. and Dan Brazier
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.25
|
|
Employment Agreement
dated October 18, 2000 between DRAXIS Health Inc. and Jack A. Carter
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.26
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated October 18, 2000
between DRAXIS Health Inc. and Jack A. Carter (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file
No. 000-17434))
|
4.27
|
|
Employment Agreement
dated April 22, 2003 between DRAXIS PHARMA Inc. and John E.M. Durham
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.28
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated April 22, 2003 between
DRAXIS PHARMA Inc. and John E.M. Durham (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file
No. 000-17434))
|
4.29
|
|
Employment Agreement
dated October 17, 2003 between DRAXIS Health Inc. and Alida Gualtieri
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.30
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated October 17, 2003
between DRAXIS Health Inc. and Alida Gualtieri (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file
No. 000-17434))
|
4.31
|
|
Employment Agreement
dated March 9, 2004 between DRAXIS Health Inc. and Chien Huang
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.32
|
|
Employment Agreement
dated March 9, 2004 between DRAXIS Health Inc. and Mark Oleksiw
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file No. 000-17434))
|
4.33
|
|
Employment Agreement
dated May 14, 2001 between DRAXIS Health Inc. and Jerry Ormiston
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2001, filed on
May 20, 2002 (SEC file no. 000-17434))
|
4.34
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated May 14, 2001 between
DRAXIS Health Inc. and Jerry Ormiston (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file
No. 000-17434))
|
135
4.35
|
|
Employment Agreement
dated October 1, 1997 between DRAXIS Health Inc. and Dr. Richard J.
Flanagan (incorporated herein by reference to the Companys Annual Report (Form 20-F)
for the year ended December 31, 2003, filed on May 14, 2004 (SEC
file No. 000-17434))
|
4.36
|
|
Amendment dated
July 23, 2001 to Employment Agreement dated October 1, 1997 between
DRAXIS Health Inc. and Dr. Richard J. Flanagan (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file
No. 000-17434))
|
4.37
|
|
Non Exclusive
Distribution Agreement dated October 25, 1995 between Frosst
Radiopharmaceuticals, a division of Merck Frosst Canada Inc. (now known as
DRAXIMAGE) and Syncor International Corporation (now known as Cardinal Health
414, LLC) (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2004, filed on March 31,
2005 (SEC file No. 000-17434))
|
4.38
|
|
Non Exclusive
Distribution Agreement dated July 12, 2000 between DRAXIMAGE and Syncor
International (now known as Cardinal Health 414, LLC) (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2004, filed on March 31, 2005 (SEC file
No. 000-17434))
|
4.39
|
|
Amendment dated
August 6, 2003 to Non Exclusive Distribution Agreement dated
July 12, 2000 between DRAXIMAGE and Syncor International (now known as
Cardinal Health 414, LLC) (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2004,
filed on March 31, 2005 (SEC file No. 000-17434))
|
4.40
|
|
Manufacturing and
Supply Agreement dated July 1, 1999 between Warner-Lambert Canada Inc.
(now known as Pfizer Consumer Healthcare, a Division of Pfizer Canada Inc.)
and DRAXIS Pharma Inc. (now known as DRAXIS Pharma, a division of DRAXIS
Specialty Pharmaceuticals Inc.) (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2004,
filed on March 31, 2005 (SEC file No. 000-17434))
|
4.41
|
|
Supply Agreement dated
December 18, 2001 between GlaxoSmithKline Inc. and DRAXIS Pharma Inc.
(now known as DRAXIS Pharma, a division of DRAXIS Specialty Pharmaceuticals
Inc.) (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2004, filed on
March 31, 2005 (SEC file No. 000-17434))
|
4.42
|
|
Manufacture and Supply
Agreement entered into between DRAXIS Pharma Inc. (now known as DRAXIS
Pharma, a division of DRAXIS Specialty Pharmaceuticals Inc.) and Bone Care
International, Inc. on March 3, 2003 (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2004, filed on March 31, 2005 (SEC file
No. 000-17434))
|
4.43
|
|
Amendment dated
August 25, 2004 to Employment Agreement dated April 27, 2004
between DRAXIS Health Inc. and Dan Brazier (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2004, filed on March 31, 2005 (SEC file
No. 000-17434))
|
4.44
|
|
Amended and Restated
Loan Agreement dated June 10, 2004 between DRAXIS Health Inc. and
National Bank of Canada (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2004,
filed on March 31, 2005 (SEC file No. 000-17434))
|
136
4.45
|
|
Amendment dated
June 23, 2004 to Employment Agreement dated April 15, 1999 between
DRAXIS Health Inc. and Martin Barkin (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2004, filed on March 31, 2005 (SEC file No. 000-17434))
|
4.46
|
|
Amendment to Credit
Facilities for DRAXIS Pharma Inc. dated March 28, 2002 between National
Bank of Canada and DRAXIS Pharma Inc. (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2001, filed on May 20, 2002 (SEC file
No. 000-17434))
|
4.47
|
|
Loan Agreement dated
March 28, 2002 among DRAXIS Pharma Inc., SGF Santé Inc. and DRAXIS
Health Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2001, filed on
May 20, 2002 (SEC file No. 000-17434))
|
4.48
|
|
Loan Agreement dated
March 28, 2002 among DRAXIS Pharma Inc., Investissement Québec and
DRAXIS Health Inc. (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2001, filed on
May 20, 2002 (SEC file No. 000-17434))
|
4.49
|
|
First Amendment to
Subscription Agreement dated October 24, 2002 among SGF Santé Inc.,
DRAXIS Health Inc. and DRAXIS Pharma Inc. (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2002, filed on May 14, 2003 (SEC file
No. 000-17434))
|
4.50
|
|
Manufacturing and Supply Master Agreement, dated January 1, 2005,
between Pfizer Canada Inc. and DRAXIS Pharma, a division of DRAXIS Specialty
Pharmaceuticals Inc.
(incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2005, filed on March 31, 2006 (SEC file
No. 000-17434))
|
4.51
|
|
Amendment, dated December 20, 2005, to Employment Agreement dated
April 27, 2004, as amended between DRAXIS Health Inc. and Dan Brazier,
Chief Operating Officer of the Company
(incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2005,
filed on March 31, 2006 (SEC file No. 000-17434))
|
4.52
|
|
Employment Agreement, dated April 22, 2005, between DRAXIS Health
Inc. and Mr. Jean-Pierre Robert, President of DRAXIMAGE, a division of
DRAXIS Specialty Pharmaceuticals Inc.
(incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2005,
filed on March 31, 2006 (SEC file No. 000-17434))
|
4.53
|
|
Retirement Compensation Arrangement Trust
Agreement, dated July 8, 2005, between DRAXIS Health Inc. and
Dr. Richard Flanagan
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2005, filed on
March 31, 2006 (SEC file No. 000-17434))
|
4.54
|
|
Charter of the Board of
Directors adopted in April 2004 (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2005, filed on March 31, 2006 (SEC file No. 000-17434))
|
4.55
|
|
Charter of the Audit
Committee amended in May 2005 (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2005, filed on March 31, 2006 (SEC file No. 000-17434))
|
4.56
|
|
Charter of the Human
Resources and Compensation Committee amended in May 2005 (incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2005, filed on March 31, 2006 (SEC file
No. 000-17434))
|
137
4.57
|
|
Charter of the
Nominating and Corporate Governance Committee amended in May 2005
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2005, filed on
March 31, 2006 (SEC file No. 000-17434))
|
4.58
|
|
2006
Stock Option Plan
(incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2006, filed on March 30, 2007 (SEC file
No. 000-17434))
|
4.59
|
|
Terms of reference of
the Non Executive Chair (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2006,
filed on March 30, 2007 (SEC file No. 000-17434))
|
4.60
|
|
Terms of reference of
the Committee Chairs (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2006,
filed on March 30, 2007 (SEC file No. 000-17434))
|
4.61
|
|
Terms of reference for
the CEO (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2006, filed on
March 30, 2007 (SEC file No. 000-17434))
|
4.62
|
|
Charter of the Audit
Committee as amended in February 2007 (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2006, filed on March 30, 2007 (SEC file
No. 000-17434))
|
4.63*
|
|
Amended 2006 Stock
Option Plan
|
4.64*
|
|
Amended Stock Option
Plan of DRAXIS Health Inc.
|
4.65*
|
|
Amended Deferred Share
Unit Plan
|
4.66*
|
|
Amended terms of
reference of the Non Executive Chair
|
4.67*
|
|
Amended terms of
reference for the CEO
|
4.68*
|
|
Manufacture and Supply
Agreement dated September 4, 2007 among DRAXIS Pharma, a division of
DRAXIS Specialty Pharmaceuticals Inc. and Johnson & Johnson Consumer
Companies, Inc.
|
4.69*
|
|
Credit Agreement dated
September 4, 2007 among DRAXIS Pharma, a division of DRAXIS Specialty
Pharmaceuticals Inc. and Johnson & Johnson Finance Corporation
|
4.70*
|
|
Distribution Agreement
dated December 20, 2007 among DRAXIMAGE LLC and Medi-Physics doing
business as GE Healthcare
|
4.71*
|
|
Amendment dated
January 31, 2008, to Employment Agreement dated October 17, 2003,
as amended between DRAXIS Health Inc. and Alida Gualtieri, General
Counsel & Secretary of the Company
|
4.72*
|
|
Amendment dated
January 31, 2008, to Employment Agreement dated March 9, 2004, as
amended between DRAXIS Health Inc. and Mark Oleksiw, Chief Financial Officer
of the Company
|
4.73*
|
|
Amendment dated
January 31, 2008, to Employment Agreement dated May 15, 2001, as
amended between DRAXIS Health Inc. and Jerry Ormiston, Executive Director,
Investor Relations of the Company
|
4.74*
|
|
Employment Agreement,
dated February 7, 2008, between DRAXIS Health Inc. and Dan Brazier,
President & CEO of the Company
|
4.75*
|
|
Employment Agreement,
dated March 3, 2008, between DRAXIS Health Inc. and Jean-Pierre Robert,
Chief Operating Officer of the Company and President of DRAXIS Specialty
Pharmaceuticals Inc.
|
4.76*
|
|
Amendment dated
March 6, 2008, to Employment Agreement dated October 17, 2003, as
amended between DRAXIS Health Inc. and Alida Gualtieri, General
Counsel & Secretary of the Company
|
8.1*
|
|
List of Subsidiaries
|
12.1*
|
|
Certification of CEO
required by Section 302 of the Sarbanes-Oxley Act of 2002
|
138
12.2*
|
|
Certification of CFO
required by Section 302 of the Sarbanes-Oxley Act of 2002
|
13.1*
|
|
Certification of CEO
required by Section 906 of the Sarbanes-Oxley Act of 2002
|
13.2*
|
|
Certification of CFO
required by Section 906 of the Sarbanes-Oxley Act of 2002
|
* Filed herewith
Portions of the
exhibits have been omitted pursuant to a confidential treatment request. This
information has been filed separately with the Securities and Exchange
Commission.
SIGNATURES
The registrant hereby certifies that it meets
all of the requirements for filing on Form 20-F and that it has duly
caused and authorized the undersigned to sign this annual report on its behalf.
DRAXIS HEALTH INC.
Date:
March 31, 2008
|
By:
|
/s/
MARK OLEKSIW
|
|
|
Chief
Financial Officer
|
|
|
|
|
|
By:
|
/s/
DAN BRAZIER
|
|
|
President and Chief
Executive Officer
|
139
EXHIBIT INDEX
DRAXIS HEALTH INC.
Form 20-F Annual
Report
Exhibit No.
|
|
Description
|
|
|
|
1.1
|
|
Articles of
Amalgamation of DRAXIS Health Inc. (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2000, filed on June 29, 2001 (SEC file no. 000-17434))
|
1.2
|
|
By-law No. 1 of
DRAXIS Health Inc. (formerly Deprenyl Research Limited) (incorporated herein
by reference to the Companys Annual Report (Form 20-F) for the year
ended December 31, 2000, filed on June 29, 2001 (SEC file no.
000-17434))
|
4.1
|
|
Master Agreement dated
November 12, 1997 among DRAXIS Health Inc., Deprenyl Animal Health Inc.
and Pfizer Inc. (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.2
|
|
License Agreement dated
November 12, 1997 between Deprenyl Animal Health Inc. and Pfizer Inc.
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.3
|
|
Letter Agreement dated
December 22, 1999 between DRAXIS Health Inc., Deprenyl Animal Health
Inc. and Pfizer Inc. (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2000,
filed on June 29, 2001 (SEC file no. 000-17434))
|
4.4
|
|
Second Amendment dated
December 18, 2001 to the Master Agreement, as amended December 22,
1999, License Agreement, Research Agreement, U.S. and Canada Manufacturing
and Supply Agreement and International Manufacturing and Supply Agreement
between Pfizer Inc., Deprenyl Animal Health, Inc. and DRAXIS Health Inc.
dated November 12, 1997 (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2001, filed on May 20, 2002 (SEC file no. 000-17434))
|
4.5
|
|
Amending Agreement
dated March 31, 2003 between DRAXIS Health, Inc., Elan Pharma
International Limited and Elan Pharmaceuticals, Inc. (incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2002, filed on May 14, 2003 (SEC file no.
000-17434))
|
4.6
|
|
First Amendment to
Subscription Agreement dated October 24, 2002 among SGF Santé Inc.,
DRAXIS Health Inc. and DRAXIS Pharma Inc. (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2002, filed on May 14, 2003 (SEC file no. 000-17434))
|
4.7
|
|
Share Purchase
Agreement dated April 22, 2004 between DRAXIS Health Inc. and SGF Santé
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.8
|
|
Share Purchase
Agreement dated July 16, 2003 between Mohammed Barkat and Draxis Pharma
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
140
4.9
|
|
Share Purchase
Agreement dated July 16, 2003 between Michel Sauvageau and DRAXIS Pharma
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.10
|
|
Term Loan Agreement
dated June 9, 1998 between National Bank of Canada and DRAXIS Pharma
Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.11
|
|
Credit
Agreement dated February 18, 2000 between National Bank of Canada and
DRAXIS Pharma Inc. (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.12
|
|
Underwriting Agreement
dated April 2, 2004 between DRAXIS Health Inc., Desjardins Securities
Inc. and CIBC World Markets Inc. (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2003, filed on May 14, 2004 (SEC file no. 000-17434))
|
4.13
|
|
Asset Purchase
Agreement dated July 22, 2003 between DRAXIS Health Inc. and Shire
Biochem Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.14
|
|
Stock Option Plan of
DRAXIS Health Inc., as amended, dated June 27, 2001 (incorporated herein
by reference to the Companys Annual Report (Form 20-F) for the year
ended December 31, 2003, filed on May 14, 2004 (SEC file no.
000-17434))
|
4.15
|
|
DRAXIS Health Inc.
Employee Stock Ownership Plan, amended and restated, effective
December 1, 1998 (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2000,
filed on June 29, 2001 (SEC file no. 000-17434))
|
4.16
|
|
DRAXIS Health Inc.
Employee Participation Share Purchase Plan, effective February 16, 1995
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.17
|
|
DRAXIS Health Inc.
Deferred Share Unit Plan for Employees (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2000, filed on June 29, 2001 (SEC file no. 000-17434))
|
4.18
|
|
DRAXIS Health Inc.
Equity Purchase Plan (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2000,
filed on June 29, 2001 (SEC file no. 000-17434))
|
4.19
|
|
DRAXIS Retirement
Savings Program (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2002, filed on
May 14, 2003 (SEC file no. 000-17434))
|
4.20
|
|
Shareholder Rights Plan
Agreement dated April 23, 2002 between DRAXIS Health Inc. and
Computershare Trust Company of Canada as trustee (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2001, filed on May 20, 2002 (SEC file no. 000-17434))
|
4.21
|
|
Employment Agreement
dated April 15, 1999 between DRAXIS Health Inc. and Dr. Martin
Barkin (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
141
4.22
|
|
Amendment dated
June 14, 2000 to Employment Agreement dated April 15, 1999 between
DRAXIS Health Inc. and Dr. Martin Barkin (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2000, filed on June 29, 2001 (SEC file no. 000-17434))
|
4.23
|
|
Retirement Compensation
Agreement dated September 24, 2003 between DRAXIS Health Inc. and
Dr. Martin Barkin (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2003,
filed on May 14, 2004 (SEC file no. 000-17434))
|
4.24
|
|
Employment Agreement
dated April 27, 2004 between DRAXIS Health Inc. and Dan Brazier
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.25
|
|
Employment Agreement
dated October 18, 2000 between DRAXIS Health Inc. and Jack A. Carter
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2000, filed on
June 29, 2001 (SEC file no. 000-17434))
|
4.26
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated October 18, 2000
between DRAXIS Health Inc. and Jack A. Carter (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file no. 000-17434))
|
4.27
|
|
Employment Agreement
dated April 22, 2003 between DRAXIS PHARMA Inc. and John E.M. Durham
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.28
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated April 22, 2003 between
DRAXIS PHARMA Inc. and John E.M. Durham (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file no. 000-17434))
|
4.29
|
|
Employment Agreement
dated October 17, 2003 between DRAXIS Health Inc. and Alida Gualtieri
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.30
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated October 17, 2003
between DRAXIS Health Inc. and Alida Gualtieri (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file no. 000-17434))
|
4.31
|
|
Employment Agreement
dated March 9, 2004 between DRAXIS Health Inc. and Chien Huang
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.32
|
|
Employment Agreement
dated March 9, 2004 between DRAXIS Health Inc. and Mark Oleksiw
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.33
|
|
Employment Agreement
dated May 14, 2001 between DRAXIS Health Inc. and Jerry Ormiston
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2001, filed on
May 20, 2002 (SEC file no. 000-17434))
|
142
4.34
|
|
Amendment dated
March 26, 2004 to Employment Agreement dated May 14, 2001 between
DRAXIS Health Inc. and Jerry Ormiston (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file no. 000-17434))
|
4.35
|
|
Employment Agreement
dated October 1, 1997 between DRAXIS Health Inc. and Dr. Richard J.
Flanagan (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2003, filed on
May 14, 2004 (SEC file no. 000-17434))
|
4.36
|
|
Amendment dated
July 23, 2001 to Employment Agreement dated October 1, 1997 between
DRAXIS Health Inc. and Dr. Richard J. Flanagan (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2003, filed on May 14, 2004 (SEC file no. 000-17434))
|
4.37
|
|
Non Exclusive
Distribution Agreement dated October 25, 1995 between Frosst
Radiopharmaceuticals, a division of Merck Frosst Canada Inc. (now known as
DRAXIMAGE) and Syncor International Corporation (now known as Cardinal Health
414, LLC) (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2004, filed on
March 31, 2005 (SEC file no. 000-17434))
|
4.38
|
|
Non Exclusive
Distribution Agreement dated July 12, 2000 between DRAXIMAGE and Syncor
International (now known as Cardinal Health 414, LLC) (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2004, filed on March 31, 2005 (SEC file no.
000-17434))
|
4.39
|
|
Amendment dated
August 6, 2003 to Non Exclusive Distribution Agreement dated
July 12, 2000 between DRAXIMAGE and Syncor International (now known as
Cardinal Health 414, LLC) (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2004,
filed on March 31, 2005 (SEC file no. 000-17434))
|
4.40
|
|
Manufacturing and
Supply Agreement dated July 1, 1999 between Warner-Lambert Canada Inc.
(now known as Pfizer Consumer Healthcare, a Division of Pfizer Canada Inc.)
and DRAXIS Pharma Inc. (now known as DRAXIS Pharma, a division of DRAXIS
Specialty Pharmaceuticals Inc.) (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2004, filed on March 31, 2005 (SEC file no. 000-17434))
|
4.41
|
|
Supply Agreement dated
December 18, 2001 between GlaxoSmithKline Inc. and DRAXIS Pharma Inc.
(now known as DRAXIS Pharma, a division of DRAXIS Specialty Pharmaceuticals
Inc.) (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2004, filed on
March 31, 2005 (SEC file no. 000-17434))
|
4.42
|
|
Manufacture and Supply
Agreement entered into between DRAXIS Pharma Inc. (now known as DRAXIS
Pharma, a division of DRAXIS Specialty Pharmaceuticals Inc.) and Bone Care
International, Inc. on March 3, 2003 (incorporated herein by
reference to the Companys Annual Report (Form 20-F) for the year ended December 31,
2004, filed on March 31, 2005 (SEC file no. 000-17434))
|
4.43
|
|
Amendment dated
August 25, 2004 to Employment Agreement dated April 27, 2004
between DRAXIS Health Inc. and Dan Brazier (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2004, filed on March 31, 2005 (SEC file no.
000-17434))
|
143
4.44
|
|
Amended and Restated
Loan Agreement dated June 10, 2004 between DRAXIS Health Inc. and
National Bank of Canada (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2004,
filed on March 31, 2005 (SEC file no. 000-17434))
|
4.45
|
|
Amendment dated
June 23, 2004 to Employment Agreement dated April 15, 1999 between
DRAXIS Health Inc. and Martin Barkin (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2004, filed on March 31, 2005 (SEC file no. 000-17434))
|
4.46
|
|
Amendment to Credit
Facilities for DRAXIS Pharma Inc. dated March 28, 2002 between National
Bank of Canada and DRAXIS Pharma Inc. (incorporated herein by reference to
the Companys Annual Report (Form 20-F) for the year ended
December 31, 2001, filed on May 20, 2002 (SEC file
No. 000-17434))
|
4.47
|
|
Loan Agreement dated
March 28, 2002 among DRAXIS Pharma Inc., SGF Santé Inc. and DRAXIS
Health Inc. (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2001, filed on
May 20, 2002 (SEC file No. 000-17434))
|
4.48
|
|
Loan Agreement dated
March 28, 2002 among DRAXIS Pharma Inc., Investissement Québec and
DRAXIS Health Inc. (incorporated herein by reference to the Companys Annual
Report (Form 20-F) for the year ended December 31, 2001, filed on
May 20, 2002 (SEC file No. 000-17434))
|
4.49
|
|
First Amendment to
Subscription Agreement dated October 24, 2002 among SGF Santé Inc.,
DRAXIS Health Inc. and DRAXIS Pharma Inc. (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2002, filed on May 14, 2003 (SEC file
No. 000-17434))
|
4.50
|
|
Manufacturing and Supply Master Agreement, dated January 1, 2005,
between Pfizer Canada Inc. and DRAXIS Pharma, a division of DRAXIS Specialty
Pharmaceuticals Inc.
(incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2005, filed on March 31, 2006 (SEC file
No. 000-17434))
|
4.51
|
|
Amendment, dated December 20, 2005, to Employment Agreement dated
April 27, 2004, as amended between DRAXIS Health Inc. and Dan Brazier,
Chief Operating Officer of the Company
(incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2005,
filed on March 31, 2006 (SEC file No. 000-17434))
|
4.52
|
|
Employment Agreement, dated April 22, 2005, between DRAXIS Health
Inc. and Mr. Jean-Pierre Robert, President of DRAXIMAGE, a division of
DRAXIS Specialty Pharmaceuticals Inc.
(incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2005,
filed on March 31, 2006 (SEC file No. 000-17434))
|
4.53
|
|
Retirement Compensation Arrangement Trust
Agreement, dated July 8, 2005, between DRAXIS Health Inc. and
Dr. Richard Flanagan
(incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2005, filed on
March 31, 2006 (SEC file No. 000-17434))
|
4.54
|
|
Charter of the Board of
Directors adopted in April 2004 (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2005, filed on March 31, 2006 (SEC file No. 000-17434))
|
4.55
|
|
Charter of the Audit
Committee amended in May 2005 (incorporated herein by reference to the
Companys Annual Report (Form 20-F) for the year ended December 31,
2005, filed on March 31, 2006 (SEC file No. 000-17434))
|
144
4.56
|
|
Charter of the Human
Resources and Compensation Committee amended in May 2005 (incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2005, filed on March 31, 2006 (SEC file
No. 000-17434))
|
4.57
|
|
Charter of the Nominating
and Corporate Governance Committee amended in May 2005 (incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2005, filed on March 31, 2006 (SEC file
No. 000-17434))
|
4.58
|
|
2006 Stock Option Plan (incorporated
herein by reference to the Companys Annual Report (Form 20-F) for the
year ended December 31, 2006, filed on March 30, 2007 (SEC file
No. 000-17434))
|
4.59
|
|
Terms of reference of
the Non Executive Chair (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2006,
filed on March 30, 2007 (SEC file No. 000-17434))
|
4.60
|
|
Terms of reference of
the Committee Chairs (incorporated herein by reference to the Companys
Annual Report (Form 20-F) for the year ended December 31, 2006,
filed on March 30, 2007 (SEC file No. 000-17434))
|
4.61
|
|
Terms of reference for
the CEO (incorporated herein by reference to the Companys Annual Report
(Form 20-F) for the year ended December 31, 2006, filed on
March 30, 2007 (SEC file No. 000-17434))
|
4.62
|
|
Charter of the Audit
Committee as amended in February 2007 (incorporated herein by reference
to the Companys Annual Report (Form 20-F) for the year ended
December 31, 2006, filed on March 30, 2007 (SEC file No. 000-17434))
|
4.63*
|
|
Amended 2006 Stock
Option Plan
|
4.64*
|
|
Amended Stock Option
Plan of DRAXIS Health Inc.
|
4.65*
|
|
Amended Deferred Share
Unit Plan
|
4.66*
|
|
Amended terms of
reference of the Non Executive Chair
|
4.67*
|
|
Amended terms of
reference for the CEO
|
4.68*
|
|
Manufacture and Supply
Agreement dated September 4, 2007 among DRAXIS Pharma, a division of
DRAXIS Specialty Pharmaceuticals Inc. and Johnson & Johnson Consumer
Companies, Inc.
|
4.69*
|
|
Credit Agreement dated
September 4, 2007 among DRAXIS Pharma, a division of DRAXIS Specialty
Pharmaceuticals Inc. and Johnson & Johnson Finance Corporation
|
4.70*
|
|
Distribution Agreement
dated December 20, 2007 among DRAXIMAGE LLC and Medi-Physics doing
business as GE Healthcare
|
4.71*
|
|
Amendment dated
January 31, 2008, to Employment Agreement dated October 17, 2003,
as amended between DRAXIS Health Inc. and Alida Gualtieri, General
Counsel & Secretary of the Company
|
4.72*
|
|
Amendment dated
January 31, 2008, to Employment Agreement dated March 9, 2004, as
amended between DRAXIS Health Inc. and Mark Oleksiw, Chief Financial Officer
of the Company
|
4.73*
|
|
Amendment dated
January 31, 2008, to Employment Agreement dated May 15, 2001, as
amended between DRAXIS Health Inc. and Jerry Ormiston, Executive Director,
Investor Relations of the Company
|
4.74*
|
|
Employment Agreement,
dated February 7, 2008, between DRAXIS Health Inc. and Dan Brazier,
President & CEO of the Company
|
4.75*
|
|
Employment Agreement,
dated March 3, 2008, between DRAXIS Health Inc. and Jean-Pierre Robert,
Chief Operating Officer of the Company and President of DRAXIS Specialty
Pharmaceuticals Inc.
|
145
4.76*
|
|
Amendment dated
March 6, 2008, to Employment Agreement dated October 17, 2003, as
amended between DRAXIS Health Inc. and Alida Gualtieri, General
Counsel & Secretary of the Company
|
8.1*
|
|
List of Subsidiaries
|
12.1*
|
|
Certification of CEO
required by Section 302 of the Sarbanes-Oxley Act of 2002
|
12.2*
|
|
Certification of CFO
required by Section 302 of the Sarbanes-Oxley Act of 2002
|
13.1*
|
|
Certification of CEO
required by Section 906 of the Sarbanes-Oxley Act of 2002
|
13.2*
|
|
Certification of CFO
required by Section 906 of the Sarbanes-Oxley Act of 2002
|
* Filed herewith
Portions of the
exhibits have been omitted pursuant to a confidential treatment request. This
information has been filed separately with the Securities and Exchange
Commission.
146
MANAGEMENTS
REPORT
The Companys management is
responsible for preparing the accompanying consolidated financial statements in
conformity with accounting principles generally accepted in the United States
of America (GAAP). In preparing these consolidated financial statements,
management selects accounting policies and uses its judgment and best
estimates, as appropriate in the circumstances. Management has determined such
amounts on a reasonable basis in order to ensure that the financial statements
are presented fairly, in all material respects.
The Company maintains a
system of internal accounting controls designed to provide reasonable
assurance, at a reasonable cost, that assets are safeguarded and that
transactions are executed and recorded in accordance with the Companys
policies. This system is supported by policies and procedures for key business
activities, by the hiring of qualified staff and by a continuous planning and
monitoring program.
Deloitte & Touche
LLP has been engaged by the Companys shareholders to audit the Consolidated
Financial Statements. During the course of their audit, Deloitte &
Touche LLP considered the Companys system of internal controls to the extent
necessary to render their opinion on the Consolidated Financial Statements; in
addition, they
were
engaged to express an opinion regarding the effectiveness of the Companys
system of internal controls over financial reporting.
The Board of Directors is
responsible for ensuring that management fulfills its responsibility for
financial reporting and is ultimately responsible for reviewing and approving
the financial statements. The Board carries out the responsibility principally
through its Audit Committee. The members of the Audit Committee are outside
directors. The Committee considers, for review by the Board of Directors and
approval by the shareholders, the engagement or reappointment of the external
auditors. Deloitte & Touche LLP has full and free access to the Audit
Committee.
Management acknowledges its
responsibility to provide financial information that is representative of the
Companys operations, is consistent and reliable, and is relevant for the
informed evaluation of the Companys activities.
(signed)
|
|
(signed)
|
|
|
|
|
|
|
DAN BRAZIER
|
|
MARK OLEKSIW, CA
|
President and Chief
Executive Officer
|
|
Chief Financial Officer
|
Toronto, Ontario,
February 22, 2008
|
|
|
F-1
MANAGEMENTS REPORT ON INTERNAL
CONTROL OVER FINANCIAL REPORTING
Our management is
responsible for establishing and maintaining adequate internal control over
financial reporting for the Company. Internal control over financial reporting
is a process designed to provide reasonable assurance regarding the reliability
of our financial reporting for external purposes in accordance with accounting
principles generally accepted in the United States of America. Internal control
over financial reporting includes maintaining records that in reasonable detail
accurately and fairly reflect the transactions and disposition of our assets;
providing reasonable assurance that transactions are recorded as necessary for
preparation of our financial statements; providing reasonable assurance that
receipts and expenditures of the Company are made in accordance with management
authorization; and providing reasonable assurance that unauthorized
acquisition, use or disposition of Company assets that could have a material
effect on our financial statements would be prevented or detected on a timely
basis. Because of its inherent limitations, internal control over financial
reporting is not intended to provide absolute assurance that a misstatement of
our financial statements would be prevented or detected. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in conditions, or that the
degree of compliance with the policies or procedures may deteriorate.
Management conducted an
evaluation of the effectiveness of our internal control over financial
reporting based on the framework in
Internal Control
Integrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission. Based on this evaluation, management
concluded that the Companys internal control over financial reporting was
effective as of December 31, 2007.
The effectiveness of the
Companys internal control over financial reporting as of December 31,
2007 has been audited by the Companys auditors, Deloitte & Touche
LLP, Independent Registered Chartered Accountants, as stated in their report
appearing on page 34.
(signed)
|
|
(signed)
|
|
|
|
|
|
|
DAN BRAZIER
|
|
MARK OLEKSIW, CA
|
President and Chief
Executive Officer
|
|
Chief Financial Officer
|
Toronto, Ontario,
February 22, 2008
|
|
|
F-2
REPORT OF INDEPENDENT REGISTERED CHARTERED
ACCOUNTANTS
TO THE SHAREHOLDERS AND BOARD OF
DIRECTORS OF DRAXIS HEALTH INC.
We have audited the internal control over financial
reporting of DRAXIS Health Inc. and subsidiaries (the Company) as of December 31,
2007, based on the criteria established in
Internal
ControlIntegrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission. The Companys management is
responsible for maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control over financial
reporting, included in the accompanying Managements Report on Internal Control
over Financial Reporting. Our responsibility is to express an opinion on the
effectiveness of the Companys internal control over financial reporting based
on our audit.
We conducted our audit in accordance with the
standards of the Public Company Accounting Oversight Board (United States).
Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an
understanding of internal control over financial reporting, assessing the risk
that a material weakness exists, testing and evaluating the design and
operating effectiveness of internal control based on the assessed risk, and
performing such other procedures as we considered necessary in the circumstances.
We believe that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting
is a process designed by, or under the supervision of, the companys principal
executive and principal financial officers, or persons performing similar
functions, and effected by the companys board of directors, management, and
other personnel to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles. A
companys internal control over financial reporting includes those policies and
procedures that (1) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the transactions and
dispositions of the assets of the company; (2) provide reasonable
assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company are being made
only in accordance with authorizations of management and directors of the
company; and (3) provide reasonable assurance regarding prevention or
timely detection of unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the financial statements.
Because of the inherent limitations of internal
control over financial reporting, including the possibility of collusion or
improper management override of controls, material misstatements due to error
or fraud may not be prevented or detected on a timely basis. Also, projections
of any evaluation of the effectiveness of the internal control over financial
reporting to future periods are subject to the risk that the controls may
become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
In our opinion, the Company maintained, in all
material respects, effective internal control over financial reporting as of December 31,
2007, based on the criteria established in
Internal Control
Integrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission.
We have also audited, in accordance with Canadian
generally accepted auditing standards and with the standards of the Public
Company Accounting Oversight Board (United States), the consolidated financial
statements as of and for the year ended December 31, 2007 of the Company
and our report dated February 22, 2008 expressed an unqualified opinion on
those financial statements and included a separate report titled
Comments by Independent Registered Chartered Accountants on
Canada-United States of America Reporting Differences
referring to
changes in accounting principles.
(signed)
DELOITTE & TOUCHE LLP
Montreal, Québec, February 22, 2008
F-3
REPORT OF INDEPENDENT REGISTERED
CHARTERED ACCOUNTANTS
TO THE SHAREHOLDERS AND BOARD OF
DIRECTORS OF DRAXIS HEALTH INC.
We have audited the
accompanying consolidated balance sheets of DRAXIS Health Inc. and subsidiaries
(the Company) as of December 31, 2007 and 2006, and the related
consolidated statements of operations, changes in equity and comprehensive
income and cash flows for each of the three years in the period ended December 31,
2007. These consolidated financial statements are the responsibility of the
Companys management. Our responsibility is to express an opinion on these
consolidated financial statements based on our audits.
We conducted our audits in
accordance with Canadian generally accepted auditing standards and the
standards of the Public Company Accounting Oversight Board (United States).
Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, these
consolidated financial statements present fairly, in all material respects, the
financial position of DRAXIS Health Inc. and subsidiaries as of December 31,
2007 and 2006, and the results of their operations and their cash flows for
each of the three years in the period ended December 31, 2007 in
accordance with accounting principles generally accepted in the United States
of America.
We have also audited, in
accordance with the standards of the Public Company Accounting Oversight Board
(United States), the Companys internal control over financial reporting as of December 31,
2007, based on the criteria established in
Internal
ControlIntegrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated February 22,
2008 expressed an unqualified opinion on the Companys internal control over
financial reporting.
(signed)
DELOITTE & TOUCHE
LLP
Montreal, Québec, February 22, 2008
COMMENTS BY THE INDEPENDENT
REGISTERED CHARTERED ACCOUNTANTS ON CANADA-UNITED STATES OF AMERICA REPORTING
DIFFERENCES
The standards of the Public
Company Accounting Oversight Board (United States) require the addition of an
explanatory paragraph (following the opinion paragraph) when there are changes
in accounting principles that have a material effect on the comparability of
the Companys financial statements, such as the changes described in Note 2(g) and
Note 3 to the consolidated financial statements. Our report to the Shareholders
and the Board of Directors, dated February 22, 2008, is expressed in
accordance with Canadian reporting standards which do not require reference to
such changes in accounting principles in the Report of Independent Registered
Chartered Accountants when the changes are properly accounted for and adequately
disclosed in the financial statements.
(signed)
DELOITTE &
TOUCHE LLP
Montreal, Québec, February 22, 2008
F-4
Consolidated Statements of Operations
(in
thousands of U.S. dollars, except share related data)
Years ended December 31
|
|
2007
|
|
2006
|
|
2005
|
|
REVENUES
|
|
|
|
|
|
|
|
Product sales
|
|
$
|
76,072
|
|
$
|
83,545
|
|
$
|
72,989
|
|
Royalty and licensing (Note 13)
|
|
2,788
|
|
5,422
|
|
6,444
|
|
|
|
78,860
|
|
88,967
|
|
79,433
|
|
EXPENSES
|
|
|
|
|
|
|
|
Cost of goods sold, excluding depreciation and amortization
|
|
49,618
|
|
47,083
|
|
46,836
|
|
Selling, general and administration
|
|
18,807
|
|
19,425
|
|
16,185
|
|
Research and development
|
|
2,446
|
|
2,372
|
|
2,103
|
|
Depreciation and amortization
|
|
5,841
|
|
5,135
|
|
4,545
|
|
|
|
76,712
|
|
74,015
|
|
69,669
|
|
Operating income
|
|
2,148
|
|
14,952
|
|
9,764
|
|
Financial income
(expense), net (Note 4)
|
|
870
|
|
347
|
|
(29
|
)
|
Foreign exchange (loss)
gain
|
|
(1,716
|
)
|
282
|
|
(398
|
)
|
Income before income taxes
|
|
1,302
|
|
15,581
|
|
9,337
|
|
Income tax (recovery)
expense (Note 5)
|
|
(356
|
)
|
4,034
|
|
1,553
|
|
Net income
|
|
$
|
1,658
|
|
$
|
11,547
|
|
$
|
7,784
|
|
|
|
|
|
|
|
|
|
Basic earnings per share (Note
6)
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.19
|
|
|
|
|
|
|
|
|
|
Diluted earnings per share
(Note 6)
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.18
|
|
See
the accompanying notes to the Consolidated Financial Statements
Approved
by the Board
(signed)
|
|
(signed)
|
|
|
|
BRIAN
KING
|
|
SAMUEL
SARICK
|
Director
|
|
Director
|
F-5
Consolidated Balance Sheets
(in
thousands of U.S. dollars, except share related data)
As at December 31
|
|
2007
|
|
2006
|
|
ASSETS
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
24,796
|
|
$
|
21,446
|
|
Restricted cash (Note 7)
|
|
1,326
|
|
|
|
Accounts receivable (Note
8)
|
|
18,059
|
|
20,683
|
|
Inventories (Note 9)
|
|
9,620
|
|
7,590
|
|
Prepaid expenses
|
|
1,358
|
|
735
|
|
Deferred income taxes, net
(Note 5)
|
|
4,119
|
|
3,179
|
|
Total
current assets
|
|
59,278
|
|
53,633
|
|
|
|
|
|
|
|
Accounts receivable, long
term (Note 8)
|
|
2,514
|
|
|
|
Property, plant and
equipment, net (Note 10)
|
|
58,494
|
|
46,292
|
|
Goodwill
|
|
885
|
|
753
|
|
Intangible assets, net
(Note 11)
|
|
240
|
|
318
|
|
Other assets
|
|
310
|
|
407
|
|
Deferred income taxes, net
(Note 5)
|
|
6,213
|
|
4,559
|
|
Total
assets
|
|
$
|
127,934
|
|
$
|
105,962
|
|
|
|
|
|
|
|
LIABILITIES
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities (Note 12)
|
|
$
|
11,904
|
|
$
|
10,940
|
|
Current portion of
deferred revenues (Note 13)
|
|
411
|
|
329
|
|
Customer deposits
|
|
385
|
|
576
|
|
Total current liabilities
|
|
12,700
|
|
11,845
|
|
|
|
|
|
|
|
Other liabilities (Note
15)
|
|
164
|
|
990
|
|
Deferred revenues (Note
13)
|
|
594
|
|
712
|
|
Customer financing (Note
16)
|
|
3,135
|
|
|
|
Total liabilities
|
|
16,593
|
|
13,547
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note 20)
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS EQUITY
|
|
|
|
|
|
Common stock, without par
value of unlimited number of shares authorized, 42,062,538 and 41,522,138
issued and outstanding at December 31, 2007 and 2006, respectively
|
|
79,814
|
|
77,749
|
|
Additional paid-in capital
|
|
15,984
|
|
15,475
|
|
Deficit
|
|
(6,576
|
)
|
(8,234
|
)
|
Accumulated other comprehensive
income
|
|
22,119
|
|
7,425
|
|
Total shareholders equity
|
|
111,341
|
|
92,415
|
|
Total liabilities and
shareholders equity
|
|
$
|
127,934
|
|
$
|
105,962
|
|
See the accompanying notes to the Consolidated
Financial Statements
F-6
Consolidated Statements of Changes in Equity and
Comprehensive Income (Loss)
(in
thousands of U.S. dollars, except share related data)
Years ended December 31
|
|
2007
|
|
2006
|
|
2005
|
|
COMMON STOCK (NUMBER OF SHARES)
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
41,522,138
|
|
41,588,005
|
|
41,015,326
|
|
Exercise of options
|
|
670,500
|
|
647,333
|
|
648,279
|
|
Repurchased for cancellation
|
|
(130,100
|
)
|
(713,200
|
)
|
(75,600
|
)
|
Balance, end of year
|
|
42,062,538
|
|
41,522,138
|
|
41,588,005
|
|
COMMON STOCK
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
$
|
77,749
|
|
$
|
77,313
|
|
$
|
75,840
|
|
Exercise of options
|
|
2,058
|
|
1,934
|
|
1,628
|
|
Fair values of options exercised
|
|
325
|
|
|
|
|
|
Repurchased for cancellation
|
|
(318
|
)
|
(1,498
|
)
|
(155
|
)
|
Balance, end of year
|
|
$
|
79,814
|
|
$
|
77,749
|
|
$
|
77,313
|
|
ADDITIONAL PAID-IN CAPITAL
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
$
|
15,475
|
|
$
|
15,370
|
|
$
|
15,546
|
|
Stock-based compensation
|
|
1,202
|
|
968
|
|
|
|
Fair values of options exercised
|
|
(325
|
)
|
|
|
|
|
Expired warrants
|
|
|
|
916
|
|
|
|
Common shares purchased for cancellation (Note (17(b))
|
|
(368
|
)
|
(1,779
|
)
|
(176
|
)
|
Balance, end of year
|
|
$
|
15,984
|
|
$
|
15,475
|
|
$
|
15,370
|
|
WARRANTS
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
$
|
|
|
$
|
916
|
|
$
|
916
|
|
Expiry of warrants (Note 17(a))
|
|
|
|
(916
|
)
|
|
|
Balance, end of year
|
|
$
|
|
|
$
|
|
|
$
|
916
|
|
DEFICIT
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
$
|
(8,234
|
)
|
$
|
(19,781
|
)
|
$
|
(27,565
|
)
|
Net income
|
|
1,658
|
|
11,547
|
|
7,784
|
|
Balance, end of year
|
|
$
|
(6,576
|
)
|
$
|
(8,234
|
)
|
$
|
(19,781
|
)
|
ACCUMULATED OTHER COMPREHENSIVE
INCOME (LOSS)
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
$
|
7,425
|
|
$
|
7,810
|
|
$
|
5,183
|
|
Other comprehensive income (loss)
|
|
14,694
|
|
(385
|
)
|
2,627
|
|
Balance, end of year
|
|
22,119
|
|
7,425
|
|
7,810
|
|
Total shareholders equity
|
|
$
|
111,341
|
|
$
|
92,415
|
|
$
|
81,628
|
|
Comprehensive Income (Loss)
|
|
|
|
|
|
|
|
Foreign currency translation adjustments
|
|
$
|
14,694
|
|
$
|
(385
|
)
|
$
|
2,627
|
|
Net income
|
|
1,658
|
|
11,547
|
|
7,784
|
|
Total comprehensive income
|
|
$
|
16,352
|
|
$
|
11,162
|
|
$
|
10,411
|
|
See the accompanying notes to the Consolidated Financial Statements
F-7
Consolidated Statements of Cash Flows
(in
thousands of U.S. dollars)
Years ended December 31
|
|
2007
|
|
2006
|
|
2005
|
|
CASH FLOWS FROM (USED IN)
OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
Net income
|
|
$
|
1,658
|
|
$
|
11,547
|
|
$
|
7,784
|
|
Adjustments to reconcile
net income to net cash from (used in) operating activities
|
|
|
|
|
|
|
|
Amortization of deferred revenues
|
|
(120
|
)
|
(3,301
|
)
|
(3,701
|
)
|
Depreciation and amortization
|
|
5,841
|
|
5,135
|
|
4,545
|
|
Stock-based compensation
|
|
1,202
|
|
968
|
|
|
|
Deferred income taxes
|
|
(1,316
|
)
|
3,227
|
|
765
|
|
Foreign exchange
|
|
1,326
|
|
(282
|
)
|
398
|
|
Deferred share unit (recovery) expense (Note 18(b))
|
|
(383
|
)
|
245
|
|
(117
|
)
|
Other
|
|
648
|
|
417
|
|
378
|
|
Changes in operating
assets and liabilities
|
|
|
|
|
|
|
|
Accounts receivable
|
|
6,825
|
|
(4,615
|
)
|
(1,903
|
)
|
Accounts receivable, long term
|
|
(2,514
|
)
|
|
|
|
|
Proceeds from customer financing used in operations
|
|
1,535
|
|
|
|
|
|
Inventories
|
|
(692
|
)
|
44
|
|
2,786
|
|
Prepaid expenses
|
|
(359
|
)
|
279
|
|
(263
|
)
|
Accounts payable and accrued liabilities
|
|
(233
|
)
|
2,280
|
|
(1,648
|
)
|
Other liabilities
|
|
(791
|
)
|
682
|
|
308
|
|
Current portion of deferred revenues
|
|
(76
|
)
|
(176
|
)
|
385
|
|
Net cash from (used in)
operating activities
|
|
12,551
|
|
16,450
|
|
9,717
|
|
CASH FLOWS (USED IN) FROM
INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
Expenditures for property, plant and equipment
|
|
(10,325
|
)
|
(5,656
|
)
|
(4,619
|
)
|
Increase in receivables related to property, plant and equipment
|
|
(1,543
|
)
|
|
|
|
|
Increase in intangible assets
|
|
(200
|
)
|
(359
|
)
|
(185
|
)
|
Restricted cash
|
|
(1,326
|
)
|
|
|
424
|
|
Proceeds from disposition of property, plant and equipment
|
|
|
|
22
|
|
|
|
Net cash from (used in)
investing activities
|
|
(13,394
|
)
|
(5,993
|
)
|
(4,380
|
)
|
CASH FLOWS (USED IN) FROM
FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
Proceeds from customer financing
|
|
3,135
|
|
|
|
|
|
Proceeds from customer financing used in operations
|
|
(1,535
|
)
|
|
|
|
|
Decrease in customer deposits, net
|
|
(74
|
)
|
(73
|
)
|
(2
|
)
|
Exercise of options
|
|
2,058
|
|
1,934
|
|
1,628
|
|
Common shares purchased for cancellation
|
|
(686
|
)
|
(3,277
|
)
|
(331
|
)
|
Net cash from (used in)
financing activities
|
|
2,898
|
|
(1,416
|
)
|
1,295
|
|
Effect of foreign exchange rate changes on cash and cash equivalents
|
|
1,295
|
|
15
|
|
(168
|
)
|
Net increase in cash and cash equivalents
|
|
3,350
|
|
9,056
|
|
6,464
|
|
Cash and cash equivalents, beginning of year
|
|
21,446
|
|
12,390
|
|
5,926
|
|
Cash and cash equivalents, end of year
|
|
$
|
24,796
|
|
$
|
21,446
|
|
$
|
12,390
|
|
|
|
|
|
|
|
|
|
Additional Information
|
|
|
|
|
|
|
|
Interest paid
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Income taxes paid
|
|
$
|
810
|
|
$
|
561
|
|
$
|
804
|
|
See the accompanying notes to the Consolidated Financial Statements
F-8
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
For the years ended December 31, 2007, 2006 and
2005 (in thousands of U.S. dollars, except share related data)
NOTE 1. NATURE OF OPERATIONS
DRAXIS Health Inc. (DRAXIS
or the Company) is a specialty pharmaceutical company providing
pharmaceutical products in three major categories: sterile, including sterile
lyophilized (freeze-dried) pharmaceuticals; non-sterile specialty
pharmaceuticals; and radiopharmaceuticals. In the radiopharmaceutical category,
DRAXIS has its own products and a targeted research and development (R&D)
program for new and/or improved products. As of January 1, 2005,
activities of the Company are carried out principally through its wholly owned
subsidiary, DRAXIS Specialty Pharmaceuticals Inc., which operates two major
divisions, DRAXIS Pharma (contract manufacturing) and DRAXIMAGE
(radiopharmaceuticals). The Companys common shares are listed on NASDAQ and
the Toronto Stock Exchange (TSX).
NOTE
2. SIGNIFICANT ACCOUNTING POLICIES
(a) Basis of Presentation
The Company has prepared these Consolidated Financial Statements in
U.S. dollars and in accordance with generally accepted accounting principles
(GAAP) in the U.S.
(b) Principles of Consolidation
The Consolidated Financial
Statements include the accounts of the Company and its wholly owned subsidiary
companies. All intercompany transactions
and balances are eliminated on consolidation.
(c) Use of Estimates
The preparation of the
Companys Consolidated Financial Statements requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosures of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses during
the reporting period. Actual results could differ from those estimates.
Significant estimates and assumptions are required when accounting for items
and matters such as asset impairments, allowance for uncollectible accounts
receivable, inventory obsolescence, warranties and provisions, depreciation and
amortization, deferred and current income taxes, stock-based compensation and
contingencies.
(d) Reporting Currency and
Foreign Currency Translation
The Companys principal
functional currency is the Canadian dollar; however, it reports its
Consolidated Financial Statements in U.S. dollars. The financial statements of
the parent company and its non-U.S. subsidiaries whose functional currency is
not the U.S. dollar are translated into U.S. dollars in accordance with
Statement of Financial Accounting Standards (SFAS) No. 52,
Foreign Currency Translation
. Asset and liability accounts
are translated at the rate of exchange prevailing at the balance sheet date.
Shareholders equity accounts are translated at the applicable historical rate.
Revenue and expense accounts are translated at the average rate of exchange for
the period. The cumulative foreign currency translation adjustment is reported
as a component of accumulated other comprehensive income in shareholders
equity. The net change in the cumulative foreign currency translation
adjustment in the periods presented is primarily due to fluctuations in the
exchange rates between the Companys reporting currency and the Canadian
dollar.
F-9
Foreign denominated monetary
assets and liabilities of the Company are translated at the exchange rates in
effect at the balance sheet dates. Revenues and expenses are translated at
average rates for the period. Resulting translation gains or losses are
reflected in net income.
(e) Revenue Recognition
Product Sales
The Company recognizes
revenue, net of trade discounts and allowances, when evidence of an arrangement
exists, delivery has occurred or services have been rendered, the price is
fixed or determinable and collectability is reasonably assured. Sales
incentives are recorded as a reduction of revenues at the time the related
revenues are recorded. Delivery has occurred when goods are shipped and title
has passed.
Amounts received from
customers as prepayments for products to be shipped or services to be provided
in the future are reported as customer deposits and recognized as revenue when
delivery has occurred or services have been rendered.
Product sales include
related service revenues that are recognized at the time of performance or
proportionately over the term of the contract, as appropriate.
Royalty and Licensing
Royalty revenue is
recognized on an accrual basis in accordance with contractual agreements when
all significant contractual obligations have been satisfied, the amounts are
determinable and collection is reasonably assured. Royalty revenue is net of
amounts owing to sublicensees where the Company is acting as an agent for the
sublicensee.
License and other forms of
non-refundable fees received pursuant to collaboration agreements are accounted
for according to the related contractual agreements. In general, such fees are
deferred and recognized on a straight-line basis over the contract period. Where
the contract period is not defined, such fees are recognized on a straight-line
basis over the estimated term, during which contractual benefits are expected
to be derived. If payment of such fees is contingent upon future performance
obligations of the Company or other future events, revenue recognition of such
amounts is deferred and recognized upon completion of the specific event.
(f) Research and Development
In accordance with SFAS No. 2,
Accounting for Research and Development Costs
,
R&D costs are expensed in the period in which they are incurred. Acquired
R&D having no alternative future use is written off at the time of
acquisition. The cost of intangibles that are purchased from others for a
particular R&D project that have no alternative future use is written off
at the time of acquisition.
(g) Stock-Based Compensation
In December 2004, the
Financial Accounting Standard Board (FASB) published SFAS No. 123R,
Share-Based Payments
. SFAS No. 123R
amends SFAS No. 123,
Stock-Based
Compensation
issued in 1995 and supersedes Accounting Principles
Board Opinion (APB) No. 25 issued in 1972. Beginning on January 1,
2006, the Company applied SFAS No. 123R using a modified version of the
prospective application for the stock options granted. The financial statements
of prior interim periods and fiscal years do not reflect any restated amounts.
Stock options are granted to employees and directors at exercise prices equal
to the fair market value of the Companys stock at the dates of grant. Stock
options generally vest equally over three or seven years and have a term of
five or ten years. Under the transition method, Compensation expense is
generally recognized over the period during which an employee is required to
provide service in exchange for the award (usually the vesting period).
Compensation cost is recognized beginning on the required effective date for
F-10
the portion of outstanding
awards for which the requisite service has not yet been rendered, based on the
grant-date fair value of those awards calculated under SFAS No. 123R for
either recognition or
pro forma
disclosures. The expenses recorded in selling, general and administration
(SG&A) and recognized for the years ended December 31, 2007 and 2006
were $1,202 and $968, respectively.
If this change in accounting
policy had been applied to the fiscal year 2005, the Companys net income,
basic income per share and diluted income per share for the years ended December 31,
2005 would have been reduced on a
pro forma
basis
as follows:
|
|
2005
|
|
|
|
|
|
Net income, as reported
|
|
$
|
7,784
|
|
Pro forma impact
|
|
(839
|
)
|
Pro forma net income
|
|
$
|
6,945
|
|
|
|
|
|
Basic earnings per share,
as reported
|
|
$
|
0.19
|
|
Pro forma impact per share
|
|
$
|
(0.02
|
)
|
Pro forma earnings per share
basic
|
|
$
|
0.17
|
|
Pro forma earnings per share
diluted
|
|
$
|
0.16
|
|
The estimated fair values of
granted stock options for the years ended December 31, 2007, 2006 and 2005
using the Black-Scholes option-pricing model with the following weighted-average
assumptions were as follows:
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Dividend yield
|
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
Expected volatility
|
|
41
|
%
|
47
|
%
|
58
|
%
|
Risk-free interest rate
|
|
4.0
|
%
|
3.9
|
%
|
3.6
|
%
|
Expected option life
|
|
5
years
|
|
5
years
|
|
6
years
|
|
Fair value per option
granted
|
|
$2.36
|
|
$1.99
|
|
$2.74
|
|
The Black-Scholes
option-pricing model was developed for use in estimating the fair value of
traded options, which have no vesting restrictions and are fully transferable
and which significantly differ from the Companys stock option awards. In
addition, option-pricing models require the input of highly subjective
assumptions including the expected price volatility. The Company uses expected
volatility rates that are based on historical volatility rates trended into future
years. Changes in the subjective input assumptions can materially affect the
fair value estimate, and therefore, the existing model does not necessarily
provide a reliable single measure of the fair value of the Companys stock
options.
(h) Income Taxes
The liability method of
accounting for income taxes is used in accordance with SFAS No. 109,
Accounting for Income Taxes
. Under this
method, deferred tax assets and liabilities are recognized for the differences
between the financial statement and income tax bases of assets and liabilities
and for operating losses and tax credit carryforwards. A valuation allowance is
provided for the portion of deferred tax assets that is more likely than not to
be unrealized. Deferred tax assets and liabilities are measured using enacted
tax rates and laws.
F-11
The Canadian Federal and
Quebec Provincial governments offer a tax incentive to companies performing
R&D activities in Canada. The federal tax incentive is calculated based on
predetermined rates, considers eligible R&D expenditures and can be used to
reduce federal income taxes in Canada otherwise payable. Such credits, if not
used in the year earned, can be carried forward for a period of 20 years. The
Quebec Provincial government offers a similar incentive, except that it is
receivable in cash instead of a credit used to reduce taxes otherwise payable.
The cash credit is awarded regardless of whether or not there are Quebec
Provincial taxes payable. These investment tax credits are recorded as a
reduction of the income tax expense.
(i) Cash and Cash Equivalents
All highly liquid
investments with original maturities of three months or less are classified as
cash and cash equivalents. The fair value of cash and cash equivalents
approximates the amounts shown in the financial statements.
(j) Allowance for Doubtful
Accounts
The Company determines an
appropriate allowance for doubtful accounts based on an account-by-account
review as opposed to a general provision assessed as a percentage of revenues.
(k) Inventories
Inventories comprise raw
materials, work-in-process and finished goods. Raw materials are valued at the
lower of standard cost and replacement cost. Standard cost approximates actual
cost, computed on a first-in, first-out basis. Work-in-process is valued at the
lower of standard cost and net realizable value and includes material, direct
labor and related manufacturing overhead costs. Finished goods are valued at
the lower of cost computed on a first-in, first-out basis, and net realizable
value, and include all related manufacturing, packaging and overhead costs.
Provisions for inventory obsolescence are charged against income when it is
determined that the inventory item does not meet the defined quality or
regulatory requirements for sale or is obsolete.
(l) Property, Plant and
Equipment
Property, plant and
equipment are reported at cost, less accumulated depreciation. The Company
provides for depreciation using the following methods and applying rates to
amortize the cost over the estimated useful life of the assets:
Building
|
|
straight-line over 25 years
|
Equipment
|
|
20%30% declining balance and straight-line over 510 years
|
Computer
software
|
|
straight-line over 7 years
|
Expenditures for construction
of assets incurred prior to productive use are reflected as assets under
construction. Depreciation commences when an asset is substantially completed
and ready for productive commercial use.
(m) Goodwill
Goodwill is not amortized;
however, it is subject to an annual impairment test, or tested more frequently
under certain circumstances. The assessment of impairment is done annually at December 31,
by applying a fair-value-based test. Measurement of the fair value of the
reporting unit is based on one or more fair value measures, including present
value techniques of estimated future cash flows.
F-12
(n) Intangible Assets
Acquired intangible assets
that do not have regulatory approval and for which there are no alternative
uses are expensed as acquired in-process R&D, and those that have
regulatory approval are capitalized. Amortization of intangibles assets
commence when its associated products are launched into the market for
commercial use.
Intangible assets with
finite lives are reported at cost, less accumulated amortization. The Company
does not have any intangible assets with indefinite lives. The Company provides
for amortization on a straight-line basis over the following estimated useful
lives:
Patents
and trademarks
|
|
10 years
|
Licenses
|
|
10 years
|
(o) Impairment of Long-lived
Assets
Long-lived assets,
principally comprising property, plant and equipment and intangible assets with
finite lives are reviewed for impairment whenever events or circumstances
indicate the carrying amount of assets may not be recoverable. The Company
evaluates recoverability of assets to be held and used by comparing their
carrying amount to the estimated future net undiscounted cash flows generated
by the assets. If such assets are considered to be impaired, the impairment
recognized is measured as the amount by which the carrying amount of the assets
exceeds the fair value of the assets.
(p) Recent Accounting
Pronouncements
In February 2007, the
FASB issued SFAS No. 159,
The Fair
Value Option for Financial Assets and Financial Liabilities
. This
statement permits entities to choose to measure many financial instruments and
certain other items at fair value. The objective is to improve financial
reporting by providing entities with the opportunity to mitigate volatility in
reported earnings caused by measuring related assets and liabilities
differently without having to apply complex hedge accounting provisions. The
Company is required to adopt the provisions of SFAS No. 159, effective January 1,
2008. The Company does not anticipate that the election, if any, of this
fair-value option will have a material effect on the Consolidated Financial
Statements.
In September 2006, FASB
issued SFAS No. 157,
Fair Value
Measurements
. This statement provides guidance for using fair value
to measure assets and liabilities. It also responds to investors requests for
expanded information about the extent to which companies measure assets and
liabilities at fair value, the information used to measure fair value, and the
effect of fair value measurements on earnings. SFAS No. 157 applies
whenever other standards require (or permit) assets or liabilities to be
measured at fair value, and does not expand the use of fair value in any new
circumstances. The Company is required to adopt the provisions of SFAS No. 157,
effective January 1, 2008. The Company does not believe that its adoption
will have a material impact on the Companys Consolidated Financial Statements.
NOTE
3. CHANGE IN ACCOUNTING POLICY
On January 1, 2007, the
Company adopted FASB Interpretation No. 48,
Accounting
for Uncertainty in Income Taxes
(FIN 48). FIN 48 prescribes a
minimum recognition threshold that a tax position is required to meet before
being recognized in the financial statements and provides guidance on
de-recognition, measurement classification, interest and penalties, accounting
in interim periods, disclosure and transition matters.
The adoption of FIN 48 did
not impact the Companys consolidated financial position, results of operations
or cash flows.
The Companys policy is to
recognize interest related to unrecognized tax benefits and penalties as
financial expense. There were no interest or penalties accrued at December 31,
2007.
F-13
As at January 1, 2007,
the Company had provided $1.0 million of valuation allowance in the deferred
tax asset accounts with respect to the tax filing position taken related to the
disposition of assets in prior years. The uncertainty arises from the fact that
the tax treatment taken is subject to interpretation and it was more likely
than not at the time of filing that the position would be successfully
challenged by the taxation authorities. If the filing position is accepted by
the taxation authorities, the provision would be reversed into income as a
reduction in deferred income tax expense in the year of acceptance. The Company
expects this matter to be resolved during 2008. The Company has not recorded
any increases and decreases in unrecognized tax benefits as a result of tax
positions taken during the current period.
There are no other known
items of a material nature with respect to uncertainty in income taxes.
The Company and its
subsidiaries income tax returns are subject to examination by tax authorities
in the various jurisdictions where they are filed. Income tax returns for the
year ended December 31, 2007 will be filed during the first six months of
2008.
NOTE 4.
FINANCIAL INCOME (EXPENSE)
|
|
2007
|
|
2006
|
|
2005
|
|
Interest income
|
|
$
|
939
|
|
$
|
521
|
|
$
|
107
|
|
Interest expense and
financial charges
|
|
(69
|
)
|
(174
|
)
|
(136
|
)
|
|
|
$
|
870
|
|
$
|
347
|
|
$
|
(29
|
)
|
NOTE 5.
INCOME TAXES
|
|
2007
|
|
2006
|
|
2005
|
|
The components of income
tax (recovery) expense are as follows:
|
|
|
|
|
|
|
|
Current
|
|
$
|
778
|
|
$
|
807
|
|
$
|
788
|
|
Deferred
|
|
(1,134
|
)
|
3,227
|
|
765
|
|
|
|
$
|
(356
|
)
|
$
|
4,034
|
|
$
|
1,553
|
|
The reported income tax
expense differs from the expected amount calculated by applying the Companys
Canadian combined federal and provincial tax rate to income before income tax
expense. The reasons for this difference and the related tax effects are as
follows:
|
|
2007
|
|
2006
|
|
2005
|
|
Income before income taxes
primarily from the Canadian operations
|
|
$
|
1,302
|
|
$
|
15,581
|
|
$
|
9,337
|
|
Canadian combined federal
and provincial tax rate
|
|
32.0
|
%
|
32.4
|
%
|
32.4
|
%
|
Expected income tax
expense
|
|
$
|
417
|
|
$
|
5,048
|
|
$
|
3,026
|
|
Increase (decrease)
resulting from:
|
|
|
|
|
|
|
|
Foreign tax rate
differences
|
|
94
|
|
114
|
|
111
|
|
Effects on deferred income
taxes from reduction in income tax rates
|
|
165
|
|
200
|
|
|
|
Reversal of deferred
income tax liability due to tax planning initiatives
|
|
(529
|
)
|
(871
|
)
|
|
|
Recognition of previously
unrecognized tax loss carryforwards
|
|
|
|
|
|
(876
|
)
|
Goodwill and other
amortization
|
|
|
|
|
|
111
|
|
Investment tax credits
|
|
(731
|
)
|
(827
|
)
|
(642
|
)
|
Non-taxable capital gains
related to milestones
|
|
(156
|
)
|
(63
|
)
|
(264
|
)
|
Other, mainly
non-deductible stock-based compensation costs
|
|
384
|
|
433
|
|
87
|
|
|
|
($356
|
)
|
$
|
4,034
|
|
$
|
1,553
|
|
F-14
Deferred income tax assets
have been provided as follows:
|
|
2007
|
|
2006
|
|
2005
|
|
Loss carryforwards and
undeducted R&D expenses
|
|
$
|
7,569
|
|
$
|
8,166
|
|
$
|
10,953
|
|
Investment tax credits
|
|
1,982
|
|
1,158
|
|
1,028
|
|
Expenses not currently
deductible for tax purposes
|
|
1,110
|
|
775
|
|
468
|
|
Deferred revenue
|
|
745
|
|
782
|
|
923
|
|
Share issuance costs
|
|
138
|
|
237
|
|
487
|
|
Net book value in excess
of tax value of property, plant and equipment
|
|
|
|
(1,152
|
)
|
(497
|
)
|
Net tax value in excess of
book value of property, plant and equipment
|
|
1,371
|
|
|
|
|
|
Tax value of intangible
assets in excess of net book value
|
|
424
|
|
747
|
|
643
|
|
Total deferred tax assets
|
|
13,339
|
|
10,713
|
|
14,005
|
|
Valuation allowance
|
|
(3,007
|
)
|
(2,975
|
)
|
(2,788
|
)
|
Net deferred tax assets
|
|
$
|
10,332
|
|
$
|
7,738
|
|
$
|
11,217
|
|
Deferred income tax assets
are classified as follows:
|
|
|
|
|
|
|
|
Current
|
|
$
|
4,119
|
|
$
|
3,179
|
|
$
|
2,750
|
|
Non-current
|
|
6,213
|
|
4,559
|
|
8,467
|
|
|
|
$
|
10,332
|
|
$
|
7,738
|
|
$
|
11,217
|
|
At December 31, 2007,
the Company has accumulated tax losses of $11,685 available for federal
purposes and $8,306 for provincial purposes in Canada, which expire from 2008
to 2015. In addition, the Company has $8,678 of undeducted scientific research
and experimental development expenditures in Canada as well as $6,727 in
Québec, which have no expiry. The Company also has $2,841 of unclaimed Canadian
investment tax credits, which expire from 2012 to 2027. These losses,
undeducted scientific research and experimental development expenditures and
investment tax credits can be used to offset future years taxes payable.
The Company has accumulated
tax losses of $6,283 for federal and state purposes in the U.S., which expire
from 2010 to 2014. Subject to certain limitations, these losses can be used to
offset future years taxable income.
In 2005, the Company
re-evaluated the tax rate applied to the temporary difference associated with
capital assets acquired in 2004.
As a result of tax planning
initiatives made possible by the purchase of the minority interest on April 22,
2004, the Company was able to increase the value of its deferred income tax
assets at December 31, 2004 and 2005 by recognizing the benefits of
previously unrecognized tax loss carryforwards and therefore decreasing the
valuation allowance.
The Companys valuation
allowance is made up of loss carryforwards in jurisdictions where taxable
income is no longer generated or where it is more likely they will not be
realized prior to expiry.
F-15
NOTE 6.
EARNINGS PER SHARE
Basic earnings per common
share is
calculated by dividing the net income by the
weighted-average number of the Companys common shares outstanding during the
period. Diluted earnings per common share is calculated by dividing the net
income by the sum of the weighted-average number of common shares that would
have been outstanding if potentially dilutive common shares had been issued
during the period. The treasury stock method is used to compute the dilutive
effect of warrants and stock options. The calculation of diluted earnings per
common share excludes any potential conversion of warrants and options that
would increase earnings per share.
The following table sets
forth the computation of basic and diluted income per share for the years ended
December 31:
|
|
2007
|
|
2006
|
|
2005
|
|
Numerator:
|
|
|
|
|
|
|
|
Net income
|
|
$
|
1,658
|
|
$
|
11,547
|
|
$
|
7,784
|
|
Denominator:
|
|
|
|
|
|
|
|
Weighted-average number of common shares outstanding basic
|
|
41,955,989
|
|
41,592,507
|
|
41,471,798
|
|
Weighted-average effect of dilutive securities:
|
|
|
|
|
|
|
|
Stock options
|
|
140,261
|
|
83,175
|
|
893,984
|
|
Weighted-average number of
common shares outstanding diluted
|
|
42,096,250
|
|
41,675,682
|
|
42,365,782
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.19
|
|
Diluted earnings per share
|
|
$
|
0.04
|
|
$
|
0.28
|
|
$
|
0.18
|
|
NOTE 7.
RESTRICTED CASH
An interest-bearing
compensating balance of $1,326 was provided to our third party payroll service
provider to guarantee payroll disbursements.
NOTE 8.
ACCOUNTS RECEIVABLE
|
|
2007
|
|
2006
|
|
Trade
|
|
$
|
18,297
|
|
$
|
20,686
|
|
Allowance for doubtful
accounts
|
|
(238
|
)
|
(454
|
)
|
Income taxes and R&D
tax credits
|
|
|
|
451
|
|
|
|
$
|
18,059
|
|
$
|
20,683
|
|
Long-term receivables relate
to a major customer sales contract and will bear interest per terms of the
agreement, which is not less than market rate, and which are
repayable beginning in 2009 as commercial production commences.
NOTE 9.
INVENTORIES
|
|
2007
|
|
2006
|
|
Raw materials
|
|
$
|
4,707
|
|
$
|
3,682
|
|
Work-in-process
|
|
1,330
|
|
1,094
|
|
Finished goods
|
|
3,583
|
|
2,814
|
|
|
|
$
|
9,620
|
|
$
|
7,590
|
|
F-16
NOTE 10.
PROPERTY, PLANT AND EQUIPMENT
|
|
2007
|
|
2006
|
|
Land
|
|
$
|
2,834
|
|
$
|
2,419
|
|
Building
|
|
20,897
|
|
17,393
|
|
Computer software
|
|
7,774
|
|
3,794
|
|
Equipment
|
|
49,286
|
|
41,930
|
|
Assets under construction
|
|
9,147
|
|
4,689
|
|
|
|
89,938
|
|
70,225
|
|
Accumulated depreciation
|
|
(31,444
|
)
|
(23,933
|
)
|
|
|
$
|
58,494
|
|
$
|
46,292
|
|
Depreciation of property,
plant and equipment was $5,696, $4,860 and $4,200, for the years ended December 31,
2007, 2006 and 2005, respectively.
NOTE 11.
INTANGIBLE ASSETS
|
|
|
|
|
|
2007
|
|
|
|
|
|
Accumulated
|
|
Net Book
|
|
|
|
Cost
|
|
Amortization
|
|
Value
|
|
Patents and trademarks
|
|
$
|
536
|
|
$
|
536
|
|
$
|
|
|
Licenses
|
|
2,582
|
|
2,342
|
|
240
|
|
Other
|
|
252
|
|
252
|
|
|
|
|
|
$
|
3,370
|
|
$
|
3,130
|
|
$
|
240
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
Accumulated
|
|
Net Book
|
|
|
|
Cost
|
|
Amortization
|
|
Value
|
|
Patents and trademarks
|
|
$
|
457
|
|
$
|
434
|
|
$
|
23
|
|
Licenses
|
|
2,173
|
|
1,889
|
|
284
|
|
Other
|
|
215
|
|
204
|
|
11
|
|
|
|
$
|
2,845
|
|
$
|
2,527
|
|
$
|
318
|
|
Amortization of intangible
assets was $145, $275 and $345, for the years ended December 31, 2007,
2006 and 2005, respectively. The aggregate amortization for
each of the five succeeding fiscal years are as follows: 2008 - $24;
2009 - $24; 2010 - $24; 2011 - $24; 2012 - $24.
NOTE 12.
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES
|
|
2007
|
|
2006
|
|
Trade
|
|
$
|
6,575
|
|
$
|
4,688
|
|
Accrued liabilities
|
|
2,313
|
|
905
|
|
Employee-related items
|
|
3,016
|
|
5,347
|
|
|
|
$
|
11,904
|
|
$
|
10,940
|
|
F-17
NOTE 13.
DEFERRED REVENUES
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
Less:
|
|
|
|
|
|
Deferred
|
|
Accumulated
|
|
|
|
Current
|
|
Long-
|
|
|
|
Revenues
|
|
Amortization
|
|
Net
|
|
Portion
|
|
Term
|
|
Anipryl
®
|
|
$
|
29,893
|
|
$
|
(29,180
|
)
|
$
|
713
|
|
$
|
119
|
|
$
|
594
|
|
Other
|
|
292
|
|
|
|
292
|
|
292
|
|
|
|
|
|
$
|
30,185
|
|
$
|
(29,180
|
)
|
$
|
1,005
|
|
$
|
411
|
|
$
|
594
|
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
Less:
|
|
|
|
|
|
Deferred
|
|
Accumulated
|
|
|
|
Current
|
|
Long-
|
|
|
|
Revenues
|
|
Amortization
|
|
Net
|
|
Portion
|
|
Term
|
|
Anipryl
®
|
|
$
|
29,893
|
|
$
|
(29,067
|
)
|
$
|
826
|
|
$
|
114
|
|
$
|
712
|
|
Other
|
|
215
|
|
|
|
215
|
|
215
|
|
|
|
|
|
$
|
30,108
|
|
$
|
(29,067
|
)
|
$
|
1,041
|
|
$
|
329
|
|
$
|
712
|
|
Amortization of deferred
revenues totalled $120, $3,301 and $3,701 for the years ended December 31,
2007, 2006, and 2005, respectively.
Anipryl
®
In December 1997, the
Company entered into an alliance with Pfizer Inc. (Pfizer), whereby Pfizer
was granted a perpetual exclusive license to market, sell and distribute
Anipryl
®
in exchange for non-refundable fees,
royalties based on the worldwide sales of
Anipryl
®
,
a manufacturing and supply agreement and a research
collaboration.
In December 1999, the
Company and Pfizer amended the terms of the alliance (the First Amendment)
whereby $9,000 of potential additional non-refundable fees were eliminated in
exchange for the Company receiving additional regulatory support for a
potential new indication and additional manufacturing data. These potential
additional non-refundable fees would have become payable if Pfizer had
exercised its right to acquire product registrations following regulatory
approval of
Anipryl
®
in designated
European countries.
In December 2001, the
Company and Pfizer further amended the terms of the alliance (the Second
Amendment) whereby the Company received a payment of $3,150 in respect of
minimum royalty entitlements for the second and third three-year periods ending
December 31, 2001 and 2002 and modifications to future royalty
entitlements. The Second Amendment also resulted in all rights to
Anipryl
®
outside of North America reverting back
to the Company, forfeiture of any additional minimum royalty entitlements and
the termination of any future collaborative research on new indications or
formulations for
Anipryl
®
.
Under the amended
arrangement, the Company is not entitled to receive any additional
non-refundable fees. The $28,090 in non-refundable fees already received from
Pfizer have been deferred and are being recognized as
revenue on a straight-line basis over the period to December 31, 2006.
The portion of the $3,150
payment allocated to the modifications of future royalty entitlements has been
deferred and is being recognized as revenue on a straight-line basis over the
period to December 31, 2013.
The portion of the $3,150
payment referable to the minimum royalty entitlement for the three-year period
ending December 31, 2001 was earned and recognized as revenue in the
fourth quarter of 2001. The portion referable to the third year in the
three-year period ending
F-18
December 31, 2002 was
deferred and recognized as revenue on a straight-line basis during 2002.
NOTE 14.
CREDIT FACILITIES
The Company chose not to
renew its credit facilities upon their scheduled expiration date in June 2007.
The Company plans to explore new credit facility arrangements in conjunction
with new business opportunities. The Company believes that its current cash
position and cash flows are sufficient to meet the Companys business needs.
NOTE 15.
OTHER LIABILITIES
Other liabilities comprise
the following:
(a)
In 2005, in connection with
the discontinuance of the brachytherapy product line, the Company recorded in
SG&A expenses an amount of $457, of which $252 is payable in quarterly
installments of $19, with the first payment due on April 30, 2006 and the
final payment due on January 31, 2010.
(b)
Incentive plans which
provide for cash payments to be made in the future to eligible participants are
based on achievement of certain targets within the year.
NOTE 16.
CUSTOMER FINANCING
During 2007, the Company
received $3.1 million in U.S. dollar-denominated customer financing related to
capital installation activities and technical transfer fees under the Companys
new contract with a major customer. The customer financing will be drawn down
as commercial batches are produced under the contract. The customer financing
will be secured by the specific capital installations made in preparation for
this contract.
NOTE 17.
SHAREHOLDERS EQUITY
(a) Common Share Offering
On April 22, 2004, the
Company closed its offering of 3,053,436 units at a price of $4.82 (CDN$6.55)
per unit for proceeds net of related expenses of $13,385 (CDN$18,213). Each
unit consisted of one common share and one-half of one share purchase warrant.
Each whole warrant entitled the holder to acquire one common share of the
Company at a price of CDN$8.50 at any time prior to April 24, 2006. Included as a component of shareholders equity was $916, which
represented the fair value of the warrants issued. The fair value of the
warrants was determined based on the price of the offering using the Black-Scholes
option-pricing model. All warrants expired unexercised on April 24, 2006.
(b) Stock Repurchase Program
On December 7, 2005,
the Board of Directors of the Company authorized the repurchase for
cancellation of up to 3,522,530 of its common shares through a Normal Course
Issuer Bid (the 2005 Issuer Bid), which represented 10% of the public float
on December 6, 2005. In accordance with the rules of the TSX, such
purchases could begin on December 15, 2005 and end no later than December 14,
2006.
During 2006, 713,200 shares
were purchased and cancelled in accordance with the 2005 Issuer Bid at an
average price of $4.59 for total consideration of $3,277. The excess of $1,779
over the stated capital of the acquired shares was deducted from additional paid-in
capital.
The Company received
approval from the TSX on December 18, 2006 to renew its Normal Course
Issuer Bid (the 2006 Issuer Bid). DRAXIS was authorized to repurchase up to
3,397,011 of its common shares, which represented 10% of the 33,970,112 common
shares
F-19
in
the public
float as of December 14, 2006, beginning on December 20, 2006 and
until December 19, 2007 or until such earlier date when the Company
purchases the maximum allowable number of shares or elects to terminate the
bid. All shares purchased will be acquired through the facilities of the TSX
and will be cancelled.
No shares were purchased in
2006 in accordance with the 2006 Issuer Bid. During 2007, 130,100 shares were
purchased and cancelled in accordance with the 2006 Issuer Bid at an average
price of $5.27 for total consideration of $686. The excess of $368 over the
stated capital of the acquired shares was deducted from additional paid-in
capital.
DRAXIS has received approval
from the TSX for its Normal Course Issuer Bid (the 2008 Issuer Bid) to
purchase up to 4,072,054 common shares, which represent approximately 10% of
the 40,720,539 common shares in the public float as at January 14, 2008.
The 2008 Issuer Bid will end
no later than January 20, 2009 or earlier if the Company purchases the
maximum allowable number of shares. All shares will be purchased through the
facilities of the TSX and will be cancelled.
Subject to any block purchases made in accordance with the rules of
the TSX, the Company is subject to a daily repurchase restriction of 23,084
common shares, which represents 25% of the average daily trading volume of the
Companys common shares for the six months ended December 31, 2007.
Any purchases made pursuant
to the 2008 Issuer Bid will be made in accordance with the rules of the
TSX and will be made at the market price of the common shares at the time of
the acquisition.
NOTE 18.
STOCK-BASED COMPENSATION PLANS
(a) Stock Option Plan
On May 18, 2006, the
shareholders approved a stock option plan referred to as the 2006 Stock Option
Plan to permit the Board of Directors to grant options to purchase common
shares to directors, officers and employees of the Company and subsidiaries in
order to encourage these persons to work towards and participate in the growth
and development of the Company and its subsidiaries. The Board of Directors
determines the exercise price per common share; the number of options for
common shares that may be allotted to each designated director, officer or
employee; the period during which any option may be exercised; and all the
terms and conditions of the option in accordance with the applicable
requirements of any relevant regulatory authority or stock exchange. The
options are exercisable for a period not exceeding ten years from the date of
the grant, and generally, options vest one-third on each of the first, second
and third anniversaries of the date of grant. The maximum number of options for
issuance under the 2006 Stock Option Plan is 1,500,000.
On February 3, 1988 and
amended on June 27, 2001, the shareholders approved a stock option plan
referred to as Stock Option Plan of DRAXIS Health Inc. to permit the Board of
Directors to grant options to purchase common shares to directors, officers,
employees and arms length consultants of the Company and its subsidiaries, so
as to link corporate compensation to enhanced shareholder value. The Board of
Directors determines the price per common share; the number of options for
common shares that may be allotted to each designated director, officer,
employee or arms length consultant; the period during which any option may be
exercised; and all the terms and conditions of the option in accordance with
the applicable requirements of any relevant regulatory authority or stock exchange.
The options are exercisable for a period not exceeding 10 years from the date
of the grant and generally options vest one-third on each of the first, second
and third anniversaries of the date of grant. The maximum number of options for
issuance under the Stock Option Plan of DRAXIS Health Inc. is 7,500,000. No
additional options are available for granting under this plan since the 2006
Stock Option Plan was adopted on May 18, 2006.
F-20
The Company has adopted a
guideline limiting the aggregate number of common shares that can be issued at
any point in time, through the exercise of options, to 13% of the Companys
outstanding common shares. As at December 31, 2007, the
aggregate number of shares issuable pursuant to outstanding options represented
4.5% (2006 5.4%) of the outstanding common shares.
The following is a summary
of the number of common shares issuable pursuant to outstanding stock options:
|
|
|
|
|
|
Outstanding
|
|
|
|
2007
|
|
2006
|
|
2005
|
|
|
|
|
|
|
|
|
|
Balance, beginning of year
|
|
2,257,995
|
|
2,652,620
|
|
2,753,232
|
|
Increase (decrease)
resulting from:
|
|
|
|
|
|
|
|
Granted
|
|
420,000
|
|
330,000
|
|
565,000
|
|
Exercised
|
|
(670,500
|
)
|
(647,333
|
)
|
(648,279
|
)
|
Cancelled
|
|
(131,667
|
)
|
(26,667
|
)
|
(17,333
|
)
|
Expired
|
|
|
|
(50,625
|
)
|
|
|
Balance, end of year
|
|
1,875,828
|
|
2,257,995
|
|
2,652,620
|
|
|
|
|
|
|
|
|
|
Exercisable at
December 31
|
|
913,328
|
|
1,310,495
|
|
1,501,898
|
|
|
|
|
|
|
|
|
|
As of December 31:
|
|
|
|
|
|
|
|
Remaining unrecognized
compensation cost related to non-vested stock options
|
|
$
|
1,408
|
|
$
|
1,708
|
|
$
|
2,014
|
|
Weighted-average remaining
requisite service period
|
|
1.7
years
|
|
1.9
years
|
|
2.8
years
|
|
|
|
|
|
|
|
|
|
Weighted-average exercise
price of options:
|
|
|
|
|
|
|
|
Outstanding, end of year
|
|
CDN$4.76
|
|
CDN$4.23
|
|
CDN$3.94
|
|
Exercisable, end of year
|
|
CDN$5.21
|
|
CDN$4.30
|
|
CDN$3.65
|
|
Granted
|
|
CDN$5.69
|
|
CDN$5.06
|
|
CDN$5.79
|
|
Exercised
|
|
CDN$3.49
|
|
CDN$3.41
|
|
CDN$3.07
|
|
Cancelled
|
|
CDN$5.17
|
|
CDN$6.20
|
|
CDN$5.06
|
|
Expired
|
|
|
|
CDN$3.33
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-21
The following table
summarizes information about stock options outstanding at December 31,
2007:
|
|
|
|
|
|
Options
Outstanding
|
|
|
|
|
|
Options
Exercisable
|
|
Range of Exercise Prices
|
|
Number
Outstanding
|
|
Weighted-
Average
Remaining
Contractual
Life
(in years)
|
|
Weighted-
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
($000s)
|
|
Number
Exercisable
|
|
Weighted-
Average
Remaining
Contractual
Life
(in years)
|
|
Weighted-
Average
Exercise
Price
|
|
Aggregate
Intrinsic
Value
($000s)
|
|
CDN$2.01$2.50
|
|
355,001
|
|
5.47
|
|
CDN$2.36
|
|
CDN$1,403
|
|
5,001
|
|
0.62
|
|
CDN$2.30
|
|
CDN$20
|
|
CDN$2.51$3.00
|
|
37,500
|
|
5.62
|
|
CDN$2.63
|
|
CDN$138
|
|
|
|
|
|
|
|
|
|
CDN$3.01$3.50
|
|
15,000
|
|
0.84
|
|
CDN$3.25
|
|
CDN$46
|
|
15,000
|
|
0.84
|
|
CDN$3.25
|
|
CDN$46
|
|
CDN$3.51$4.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CDN$4.01$4.50
|
|
125,000
|
|
1.00
|
|
CDN$4.30
|
|
CDN$251
|
|
125,000
|
|
1.00
|
|
CDN$4.30
|
|
CDN$251
|
|
CDN$4.51$5.00
|
|
130,000
|
|
1.61
|
|
CDN$4.70
|
|
CDN$209
|
|
130,000
|
|
1.61
|
|
CDN$4.70
|
|
CDN$209
|
|
CDN$5.01$6.65
|
|
1,213,327
|
|
3.64
|
|
CDN$5.58
|
|
CDN$895
|
|
638,327
|
|
2.67
|
|
CDN$5.52
|
|
CDN$507
|
|
|
|
1,875,828
|
|
3.70
|
|
CDN$4.76
|
|
CDN$2,942
|
|
913,328
|
|
2.26
|
|
CDN$5.21
|
|
CDN$1,034
|
|
(b) Deferred Share Unit Plan
Under the Companys Deferred
Share Unit Plan, members of senior management can elect to receive up to 20% of
base salary and up to 100% of any bonus payable in respect of that year in
deferred share units (DSUs) in lieu of cash compensation. An election must be
made by December 1 of each year in respect of base salary and bonus for
the following year. The elected amount is converted to a number of DSUs equal
to the elected amount divided by the closing price of the common shares on the
TSX or NASDAQ on December 31 of each year, based on a purchase commitment
as of December 1 of the prior year. Participants are not entitled to
redeem any DSUs until cessation of employment with the Company for any reason.
The value of each DSU redeemable by the participants will be equivalent to the
market value of a common share at the time of redemption. The DSUs must be
redeemed no later than the end of the first calendar year commencing after the
date of cessation of employment. The DSU liability is re-measured at the end of
each reporting period based on the market price of the Companys common stock.
The net increase or decrease in the value of the DSUs is recorded as
compensation cost included in SG&A expense.
The following summarizes the
number of DSUs issued and outstanding and their impact on SG&A:
|
|
2007
|
|
2006
|
|
2005
|
|
Balance, beginning of year
|
|
230,447
|
|
199,868
|
|
190,313
|
|
Issued
|
|
|
|
30,579
|
|
9,555
|
|
Cancelled
|
|
(429
|
)
|
|
|
|
|
Balance, end of year
|
|
230,018
|
|
230,447
|
|
199,868
|
|
|
|
|
|
|
|
|
|
DSU (recovery) expense
|
|
$
|
(383
|
)
|
$
|
245
|
|
$
|
(117
|
)
|
|
|
|
|
|
|
|
|
|
|
|
F-22
NOTE 19.
SEGMENTED INFORMATION AND MAJOR CUSTOMERS
Industry Segmentation
For purposes of operating
decision-making and assessing performance, management considers that it
operates in three segments: Radiopharmaceuticals, Manufacturing, and Corporate
and Other. Executive management assesses the
performance of each segment based on segment income. The segments are
identified as reporting segments based on the distinct management teams,
customer base, production process and regulatory requirements of each. The
Corporate and Other segment includes revenues earned via royalties and
milestones, inter-segment eliminations and corporate expenses. The accounting
policies used to determine segmented results and measure segmented assets are
the same as those described in the significant accounting policies.
Years ended December 31
|
|
2007
|
|
2006
|
|
2005
|
|
PRODUCT SALES REVENUES
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
23,216
|
|
$
|
21,508
|
|
$
|
19,290
|
|
Manufacturing
|
|
54,926
|
|
64,731
|
|
54,743
|
|
Corporate and Other
|
|
(2,070
|
)
|
(2,694
|
)
|
(1,044
|
)
|
|
|
$
|
76,072
|
|
$
|
83,545
|
|
$
|
72,989
|
|
ROYALTY AND LICENSING REVENUES
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
|
|
$
|
(3
|
)
|
$
|
9
|
|
Manufacturing
|
|
|
|
|
|
|
|
Corporate and Other
|
|
2,788
|
|
5,425
|
|
6,435
|
|
|
|
$
|
2,788
|
|
$
|
5,422
|
|
$
|
6,444
|
|
TOTAL REVENUES
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
23,216
|
|
$
|
21,505
|
|
$
|
19,299
|
|
Manufacturing
|
|
54,926
|
|
64,731
|
|
54,743
|
|
Corporate and Other
|
|
718
|
|
2,731
|
|
5,391
|
|
|
|
$
|
78,860
|
|
$
|
88,967
|
|
$
|
79,433
|
|
PRODUCT GROSS MARGIN
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
12,976
|
|
$
|
13,433
|
|
$
|
11,593
|
|
Manufacturing
|
|
13,390
|
(1)
|
23,215
|
|
14,628
|
|
Corporate and Other
|
|
88
|
|
(186
|
)
|
(68
|
)
|
|
|
$
|
26,454
|
|
$
|
36,462
|
|
$
|
26,153
|
|
SELLING, GENERAL AND
ADMINISTRATION EXPENSE
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
5,382
|
|
$
|
4,380
|
|
$
|
4,660
|
|
Manufacturing
|
|
6,362
|
|
6,487
|
|
5,086
|
|
Corporate and Other(2)
|
|
7,063
|
|
8,558
|
|
6,439
|
|
|
|
$
|
18,807
|
|
$
|
19,425
|
|
$
|
16,185
|
|
RESEARCH AND DEVELOPMENT
EXPENSE
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
2,446
|
|
$
|
2,372
|
|
$
|
2,103
|
|
Manufacturing
|
|
|
|
|
|
|
|
Corporate and Other
|
|
|
|
|
|
|
|
|
|
$
|
2,446
|
|
$
|
2,372
|
|
$
|
2,103
|
|
SEGMENT INCOME (LOSS)(3)
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
5,148
|
|
$
|
6,678
|
|
$
|
4,839
|
|
Manufacturing
|
|
7,028
|
|
16,728
|
|
9,542
|
|
Corporate and Other
|
|
(4,187
|
)
|
(3,319
|
)
|
(72
|
)
|
|
|
$
|
7,989
|
|
$
|
20,087
|
|
$
|
14,309
|
|
F-23
|
|
|
|
|
|
|
|
DEPRECIATION AND AMORTIZATION
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
1,096
|
|
$
|
1,110
|
|
$
|
1,047
|
|
Manufacturing
|
|
4,390
|
|
3,688
|
|
3,105
|
|
Corporate and Other
|
|
355
|
|
337
|
|
393
|
|
|
|
$
|
5,841
|
|
$
|
5,135
|
|
$
|
4,545
|
|
OPERATING INCOME (LOSS)(4)
|
|
|
|
|
|
|
|
Radiopharmaceuticals
|
|
$
|
4,052
|
|
$
|
5,568
|
|
$
|
3,792
|
|
Manufacturing
|
|
2,638
|
|
13,040
|
|
6,437
|
|
Corporate and Other
|
|
(4,542
|
)
|
(3,656
|
)
|
(465
|
)
|
|
|
$
|
2,148
|
|
$
|
14,952
|
|
$
|
9,764
|
|
Identifiable Assets
|
|
2007
|
|
2006
|
|
2005
|
|
Radiopharmaceuticals
|
|
$
|
19,560
|
|
$
|
15,332
|
|
$
|
12,340
|
|
Manufacturing
|
|
68,117
|
|
54,162
|
|
52,664
|
|
Corporate and Other
|
|
40,257
|
|
36,468
|
|
30,816
|
|
|
|
$
|
127,934
|
|
$
|
105,962
|
|
$
|
95,820
|
|
Geographic Segmentation
|
|
2007
|
|
2006
|
|
2005
|
|
REVENUES(5)
|
|
|
|
|
|
|
|
Canada
|
|
$
|
36,061
|
|
$
|
39,891
|
|
$
|
39,026
|
|
United States
|
|
40,336
|
|
47,900
|
|
39,612
|
|
Other
|
|
2,463
|
|
1,176
|
|
795
|
|
|
|
$
|
78,860
|
|
$
|
88,967
|
|
$
|
79,433
|
|
(1) Includes $517 of
insurance proceeds related to a business interruption claim filed resulting
from equipment damage during the 2005 shutdown period.
(2) Stock-based
compensation expense was recorded in SG&A expense of $1,202 in 2007 (2006
$968; 2005 $nil).
(3) Income (loss)
before depreciation and amortization, financial income (expense), foreign
exchange (loss) gain and income taxes.
(4) Income (loss)
before financial income (expense), foreign exchange (loss) gain and income
taxes.
(5) Revenues are
attributable to countries based upon the location of the customer.
Long-Lived Assets
Substantially all of the Companys
property, plant and equipment, goodwill and intangible assets are located in
Canada. Goodwill is recorded within the radiopharmaceutical segment
.
F-24
Expenditures for Property,
Plant and Equipment
|
|
2007
|
|
2006
|
|
2005
|
|
Radiopharmaceuticals
|
|
$
|
1,243
|
|
$
|
1,434
|
|
$
|
461
|
|
Manufacturing
|
|
9,063
|
|
4,222
|
|
4,119
|
|
Corporate and Other
|
|
19
|
|
|
|
39
|
|
|
|
$
|
10,325
|
|
$
|
5,656
|
|
$
|
4,619
|
|
|
|
|
|
|
|
|
|
Product
Sales Revenues By Major Product Groups
|
|
2007
|
|
2006
|
|
2005
|
|
Radiopharmaceuticals
|
|
$
|
23,216
|
|
$
|
21,508
|
|
$
|
19,290
|
|
Manufacturing Sterile
|
|
38,620
|
|
51,529
|
|
41,488
|
|
Manufacturing Non
Sterile
|
|
16,306
|
|
13,202
|
|
13,255
|
|
Corporate and Other
|
|
686
|
|
295
|
|
499
|
|
Inter-segment eliminations
|
|
(2,756
|
)
|
(2,989
|
)
|
(1,543
|
)
|
|
|
$
|
76,072
|
|
$
|
83,545
|
|
$
|
72,989
|
|
|
|
|
|
|
|
|
|
Major
Customers
|
|
2007
|
|
2006
|
|
2005
|
|
Customer A Manufacturing
|
|
15.0
|
%
|
23.0
|
%
|
23.0
|
%
|
Customer B Manufacturing
|
|
19.0
|
%
|
23.0
|
%
|
22.0
|
%
|
Customer C Manufacturing
|
|
11.0
|
%
|
10.0
|
%
|
13.0
|
%
|
Customer D
Radiopharmaceuticals
|
|
10.0
|
%
|
9.0
|
%
|
9.0
|
%
|
|
|
55.0
|
%
|
65.0
|
%
|
67.0
|
%
|
NOTE 20.
COMMITMENTS AND CONTINGENCIES
Operating Leases and Service Contracts
The operating leases relate
to the rental of warehousing and parking facilities. Service contracts relate
to a portion of information services outsourced to a third party.
The Company is committed
under various contractual commitments requiring minimum annual payments as
follows:
|
|
|
|
Payment
due by end of:
|
|
|
|
Total
|
|
2008
|
|
2009
|
|
2010
|
|
2011
|
|
2012
|
|
Thereafter
|
|
Contractual Obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases
|
|
3,955
|
|
399
|
|
595
|
|
570
|
|
566
|
|
566
|
|
1,259
|
|
Service contracts
|
|
1,339
|
|
591
|
|
358
|
|
193
|
|
124
|
|
60
|
|
13
|
|
Total contractual
obligations
|
|
5,294
|
|
990
|
|
953
|
|
763
|
|
690
|
|
626
|
|
1,272
|
|
All contractual obligations
related to 2007 and 2006 were fully paid as of December 31, 2007 and December 31,
2006, respectively.
Legal Proceedings
From time to time, the
Company becomes involved in legal proceedings and claims that arise in the
ordinary course of business.
F-25
The Company considers that
the ultimate liability with respect to any known actions will not materially
affect the business, financial position, results of operations or cash flows of
the Company.
On July 22, 2005, the
Company announced that, together with other defendants, it had received a
Statement of Claim filed before the Superior Court of Justice
of Ontario wherein the plaintiff alleges that
Permax
®
,
a drug that the Company distributed in Canada for a third-party manufacturer
prior to July 2003, causes compulsive/obsessive behaviour, including
pathological gambling. The plaintiff is seeking to have this action
certified as a class action. The Company
believes this claim against it is without merit and intends to vigorously
defend this proceeding and any motion for certification. Prior to July 2003,
Permax
®
was distributed in Canada by DRAXIS Pharmaceutica, the Canadian pharmaceutical
sales and marketing division of the Company. In July 2003, the Company
completed the divestiture of the DRAXIS Pharmaceutica division to Shire. No
provisions have been taken pursuant to this claim.
On February 29, 2008,
the plaintiff served an Amended Statement of Claim and a Motion Record in
support of the plaintiffs motion for certification of this action as a class
proceeding. It is anticipated that a
class proceedings judge will be assigned to this action on March 20, 2008,
and that the assigned class proceedings judge will set a schedule for
completion of the remaining pre-certification steps and for the certification
motion.
NOTE 21.
RELATED PARTY TRANSACTIONS
Significant related party
transactions and balances in the accompanying financial statements are as
follows:
|
|
2007
|
|
2006
|
|
2005
|
|
Rent paid to a company
jointly controlled by a member of the Board of Directors included in SG&A
expenses
|
|
$
|
131
|
|
$
|
127
|
|
$
|
123
|
|
|
|
|
|
|
|
|
|
|
|
|
The aforementioned
transaction is in the normal course of operations, is measured at the exchange
amount, which is the amount of consideration established and agreed to by the
related parties, and has been fully paid as of the balance sheet dates.
NOTE 22.
FINANCIAL INSTRUMENTS
Fair Value
The fair values of cash and
cash equivalents, restricted cash, accounts receivable, accounts payable and
accrued liabilities approximate their carrying values because of the short-term
maturity of those instruments. The Company is not party to any derivative
instruments. The carrying amount of our long-term accounts receivable and
long-term customer financing approximates its fair value as the effective
interest rate for this receivable and customer financing is comparable to
market rates at December 31, 2007 for similar issuances.
Credit Risk
The Company is subject to
credit risk through trade receivables and short-term cash investments. Credit
risk with respect to trade receivables is limited given the creditworthiness of
the counterparties. The Company invests its excess liquidity in high quality
government securities and short-term commercial paper, bank deposits and money
market mutual funds.
Currency Risk
The Companys foreign
exchange exposure for accounting purposes mainly relates to the
U.S.-denominated monetary assets and liabilities of the Canadian operations of
the Company. Changes in the exchange rate may result in a decrease or increase
in the foreign exchange gain or loss. The Company does not actively hedge this
exposure but reduces the exposure by maintaining the minimum level of
U.S.-denominated cash available to meet its short-term cash requirements.
NOTE 23.
COMPARATIVE INFORMATION
The Company has reclassified
certain prior years information to conform with the
current years presentation.
F-26
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