UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x
Quarterly
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934
For
the quarterly period ended September 30, 2008.
¨
Transition
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act
of 1934
For
the transition period from ___________ to ___________
Commission
file number: 000-52454
RxElite,
Inc.
(Name
of
Small Business Issuer in its Charter)
Delaware
|
|
90-0366910
|
State
or other Jurisdiction of
|
|
I.R.S.
Employer
|
Incorporation
or Organization
|
|
Identification
No.
|
1404
North Main, Suite 200
|
|
|
Meridian,
Idaho
|
|
83642
|
Address
of Principal Executive Offices
|
|
Zip
Code
|
Registrant's
telephone number, including area code (208) 288-5550
(Former
name or former address, if changed since last report)
Check
whether the issuer (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 issuer 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, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act
.
Large
accelerated filer
¨
|
|
Accelerated
filer
¨
|
|
|
|
Non-accelerated
filer (Do not check if a smaller reporting company)
¨
|
|
Smaller
reporting company
x
|
Indicate
by check mark whether the issuer is a shell company (as defined in Rule 12b-2
of
the Exchange Act).
Yes
¨
No
x
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date:
Class
|
|
Outstanding
at November 11, 2008
|
Common
Stock, $0.001 Par Value
|
|
119,705,157
|
Transitional
Small Business Disclosure Format (Check One): Yes
¨
No
x
RXELITE,
INC.
FORM
10-Q
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
|
Item
1.
|
Financial
Statements
|
|
2
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets, September 30, 2008 (unaudited) and December
31, 2007 (audited)
|
|
2
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations for the Three and Nine Months
ended
September 30, 2008 and 2007 (unaudited)
|
|
3
|
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows for the Nine Months ended September
30, 2008 and 2007 (unaudited)
|
|
4
|
|
|
|
|
|
Notes
to Condensed Consolidated Financial Statements
|
|
5
|
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis or Plan of Operations
|
|
15
|
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk.
|
|
24
|
|
|
|
|
Part
II - OTHER INFORMATION
|
|
|
|
|
|
Item
1.
|
Legal
proceedings.
|
|
25
|
|
|
|
|
Item
1A.
|
Risk
Factor
|
|
25
|
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and use of Proceeds
|
|
26
|
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities.
|
|
27
|
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders.
|
|
27
|
|
|
|
|
Item
5.
|
Other
Information.
|
|
27
|
|
|
|
|
Item
6.
|
Exhibits
|
|
27
|
PART
1 - FINANCIAL INFORMATION
Item
1. Financial Statements
RXELITE,
INC.
Condensed
Consolidated Balance Sheets
|
|
September 30,
|
|
December 31,
|
|
|
|
2008
|
|
2007
|
|
|
|
(Unaudited)
|
|
(Audited)
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
1,348,216
|
|
$
|
10,113,584
|
|
Accounts
receivable, net of discounts and allowances of $32,913 and $8,006,
respectively
|
|
|
987,229
|
|
|
494,762
|
|
Related
party accounts receivable
|
|
|
-
|
|
|
465,378
|
|
Related
party receivable
|
|
|
5,585
|
|
|
8,945
|
|
Inventory
|
|
|
5,172,498
|
|
|
7,353,339
|
|
Prepaid
expenses
|
|
|
802,311
|
|
|
94,272
|
|
Total
Current Assets
|
|
|
8,315,839
|
|
|
18,530,280
|
|
|
|
|
|
|
|
|
|
Fixed
Assets, Net
|
|
|
7,823,349
|
|
|
1,832,573
|
|
|
|
|
|
|
|
|
|
Intangible
Assets, Net
|
|
|
5,302,429
|
|
|
67,194
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
10,678,793
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Other
Assets:
|
|
|
|
|
|
|
|
Restricted
deposits
|
|
|
754,153
|
|
|
682,680
|
|
Other
assets
|
|
|
154,529
|
|
|
153,638
|
|
Total
Other Assets
|
|
|
908,682
|
|
|
836,318
|
|
TOTAL
ASSETS
|
|
$
|
33,029,092
|
|
$
|
21,266,365
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
7,794,452
|
|
$
|
5,720,737
|
|
Accrued
rebates
|
|
|
612,538
|
|
|
273,148
|
|
Notes
payable - related party
|
|
|
100,000
|
|
|
100,000
|
|
Accrued
payroll and associated liabilities
|
|
|
780,551
|
|
|
673,918
|
|
Accrued
interest
|
|
|
543,750
|
|
|
-
|
|
Current
portion of severance obligation
|
|
|
306,633
|
|
|
334,009
|
|
Current
portion of capital lease obligations
|
|
|
48,296
|
|
|
43,433
|
|
Stock
liability due to Directors and/or Employees
|
|
|
11,338
|
|
|
-
|
|
Payable
to former preferred stockholders, net of discount of
$36,077
|
|
|
1,555,623
|
|
|
-
|
|
Total
Current Liabilities
|
|
|
11,753,181
|
|
|
7,145,245
|
|
|
|
|
|
|
|
|
|
Long
Term Liabilities:
|
|
|
|
|
|
|
|
Severance
obligation, net of discount $67,582
|
|
|
246,410
|
|
|
455,881
|
|
Payable
to former preferred stockholders, net
|
|
|
-
|
|
|
1,255,692
|
|
Capital
lease obligations
|
|
|
26,076
|
|
|
56,904
|
|
Senior
secured convertible note, net of discount of $6,567,486 and $10,444,152,
respectively
|
|
|
3,932,514
|
|
|
55,848
|
|
Note
Payable
|
|
|
3,000,000
|
|
|
-
|
|
Total
Long Term Liabilities
|
|
|
7,205,000
|
|
|
1,814,325
|
|
Total
Liabilities
|
|
|
18,958,181
|
|
|
8,959,570
|
|
|
|
|
|
|
|
|
|
Stockholders'
Equity:
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 Par Value, 1,000,000 Shares Authorized, 0 Shares Issued
and
Outstanding
|
|
|
-
|
|
|
-
|
|
Common
stock, $0.001 Par Value, 200,000,000 Share Authorized, 119,705,157
and
96,682,920 Shares Issued and Outstanding, respectively
|
|
|
119,705
|
|
|
96,683
|
|
Additional
paid-in capital
|
|
|
66,982,087
|
|
|
40,845,792
|
|
Accumulated
deficit
|
|
|
(53,030,881
|
)
|
|
(28,635,680
|
)
|
Total
Stockholders' Equity
|
|
|
14,070,911
|
|
|
12,306,795
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
$
|
33,029,092
|
|
$
|
21,266,365
|
|
See
notes
to Condensed Consolidated Financial Statements
RXELITE,
INC.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
REVENUES,
(Net of discounts and allowances of $1,199,043, $187,974, $3,071,330,
and
$439,066, respectively)
|
|
$
|
3,257,718
|
|
$
|
753,962
|
|
$
|
9,263,158
|
|
$
|
1,636,435
|
|
COST
OF SALES
|
|
|
2,951,207
|
|
|
623,446
|
|
|
7,898,368
|
|
|
1,322,945
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT
|
|
|
306,511
|
|
|
130,516
|
|
|
1,364,790
|
|
|
313,490
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling
expense
|
|
|
173,361
|
|
|
1,138,810
|
|
|
521,166
|
|
|
2,374,544
|
|
Product
Purchase Agreements
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
4,400,000
|
|
Salaries,
wages, and benefits expense
|
|
|
2,018,858
|
|
|
408,627
|
|
|
5,510,062
|
|
|
1,509,120
|
|
Research
and development
|
|
|
(16,714
|
)
|
|
895,755
|
|
|
(8,551
|
)
|
|
2,444,871
|
|
General
and administrative expense
|
|
|
957,644
|
|
|
632,714
|
|
|
3,113,746
|
|
|
1,301,107
|
|
Amortization
expense
|
|
|
150,807
|
|
|
650
|
|
|
398,327
|
|
|
1,951
|
|
Depreciation
expense
|
|
|
177,751
|
|
|
60,629
|
|
|
532,791
|
|
|
138,498
|
|
Total
Operating Expense
|
|
|
3,461,707
|
|
|
3,137,185
|
|
|
10,067,541
|
|
|
12,170,091
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM CONTINUING OPERATIONS
|
|
|
(3,
155,196
|
)
|
|
(3,006,669
|
)
|
|
(8,702,751
|
)
|
|
(11,856,601
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
|
15,169
|
|
|
11,189
|
|
|
42,153
|
|
|
50,578
|
|
Interest
expense and penalties
|
|
|
(521,385
|
)
|
|
(11,483
|
)
|
|
(1,278,106
|
)
|
|
(174,844
|
)
|
Loss
on Debt Restructuring
|
|
|
-
|
|
|
(170,000
|
)
|
|
-
|
|
|
(358,054
|
)
|
Amortization
of debt discount
|
|
|
(1,364,390
|
)
|
|
-
|
|
|
(4,089,106
|
)
|
|
-
|
|
Loss
on note conversion rate change
|
|
|
(5,904,253
|
)
|
|
-
|
|
|
(11,169,982
|
)
|
|
-
|
|
Loss
on deposit
|
|
|
(46,484
|
)
|
|
|
|
|
(46,484
|
)
|
|
|
|
Termination
of development agreement
|
|
|
-
|
|
|
-
|
|
|
846,666
|
|
|
-
|
|
Other
income (expense)
|
|
|
10,777
|
|
|
13,946
|
|
|
2,409
|
|
|
13,387
|
|
Total
Other (Expense)
|
|
|
(7,810,566
|
)
|
|
(156,348
|
)
|
|
(15,692,450
|
)
|
|
(468,933
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
(LOSS)
|
|
$
|
(10,965,762
|
)
|
$
|
(3,163,017
|
)
|
$
|
(24,395,201
|
)
|
$
|
(12,325,534
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted income (loss) per share
|
|
$
|
(0.09
|
)
|
$
|
(0.04
|
)
|
$
|
(0.21
|
)
|
$
|
(0.23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding
|
|
|
116,536,380
|
|
|
78,799,145
|
|
|
115,978,842
|
|
|
53,727,416
|
|
See
Notes
to Condensed Consolidated Financial Statements
RXELITE,
INC.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
|
2008
|
|
|
2007
|
|
Cash
Flows from Operating Activities:
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(24,395,201
|
)
|
$
|
(12,325,534
|
)
|
Adjustments
to Reconcile Net Loss to Net Cash Used in Operating
Activities:
|
|
|
|
|
|
|
|
Depreciation
and Amortization
|
|
|
845,156
|
|
|
199,233
|
|
Depreciation
expense allocated to COGS
|
|
|
895,207
|
|
|
-
|
|
Amortization
of debt discount
|
|
|
4,089,106
|
|
|
-
|
|
Amortization
of capitalized costs
|
|
|
85,962
|
|
|
-
|
|
Amortization
of costs associated with consulting agreement
|
|
|
640,000
|
|
|
-
|
|
(Gain)
Loss on Debt Restructuring
|
|
|
-
|
|
|
188,054
|
|
Fair
value of stock, options, stock appreciation rights, and stock purchase
rights issued and vesting
|
|
|
794,686
|
|
|
172,112
|
|
Subscription
Shares Issued for Employee Compensation
|
|
|
-
|
|
|
2,575
|
|
Subscription
Shares Issued for Services
|
|
|
-
|
|
|
3,495
|
|
Subscription
Shares Issued for Product Purchase Agreements
|
|
|
-
|
|
|
4,400,000
|
|
Termination
of development agreement
|
|
|
(846,666
|
)
|
|
-
|
|
Loss
on deposit
|
|
|
46,484
|
|
|
-
|
|
Loss
from change in conversion rate of Note
|
|
|
11,169,982
|
|
|
-
|
|
Decrease
(Increase) in Operating Assets:
|
|
|
|
|
|
|
|
Accounts
and Related Party Receivables, Net
|
|
|
(475,810
|
)
|
|
(929,981
|
)
|
Inventory
|
|
|
(978,272
|
)
|
|
(2,072,412
|
)
|
Prepaid
Expenses
|
|
|
(528,039
|
)
|
|
593
|
|
Other
Assets
|
|
|
(204,810
|
)
|
|
(641,182
|
)
|
Increase
(Decrease) in Operating Liabilities:
|
|
|
|
|
|
|
|
Accounts
Payable
|
|
|
2,920,381
|
|
|
(3,779,240
|
)
|
Accrued
Expenses
|
|
|
1,187,773
|
|
|
553,927
|
|
Net
Cash Used in Operating Activities
|
|
|
(4,754,061
|
)
|
|
(14,228,360
|
)
|
|
|
|
|
|
|
|
|
Cash
Flows from Investing Activities:
|
|
|
|
|
|
|
|
Purchase
of assets
|
|
|
(6,703,834
|
)
|
|
(689,998
|
)
|
Net
Cash Used in Investing Activities
|
|
|
(6,703,834
|
)
|
|
(689,998
|
)
|
|
|
|
|
|
|
|
|
Cash
Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from Issuance of Common Stock and Common Stock Subscribed
|
|
|
-
|
|
|
15,714,161
|
|
Payments
on capital lease obligations
|
|
|
(25,965
|
)
|
|
(19,473
|
)
|
Cash
Paid for Offering Costs
|
|
|
-
|
|
|
(1,347,458
|
)
|
Cash
Distribution to Former Preferred Shareholders
|
|
|
-
|
|
|
(600,000
|
)
|
Proceeds
from Notes Payable
|
|
|
3,000,000
|
|
|
-
|
|
Payments
on Notes Payable
|
|
|
(281,508
|
)
|
|
(832,952
|
)
|
Net
Cash Used by Financing Activities
|
|
|
2,692,527
|
|
|
12,914,278
|
|
|
|
|
|
|
|
|
|
Net
Increase (Decrease) in Cash and Cash Equivalents
|
|
|
(8,765,368
|
)
|
|
(2,004,080
|
)
|
Cash
and Cash equivalents, Beginning of Period
|
|
|
10,113,584
|
|
|
2,403,144
|
|
Cash
and Cash Equivalents, End of Period
|
|
$
|
1,348,216
|
|
$
|
399,064
|
|
See
notes
to Condensed Consolidated Financial Statements
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
1 - ORGANIZATION AND MERGER
RxElite,
Inc. (hereinafter “we”, “us” or “our”) develops and markets specialty generic
prescription drug products in the areas of anesthesia, and sterile liquid dose
drugs (which includes ophthalmic and sterile inhalation respiratory products
and
injectible drugs), as well as manufacturers active pharmaceutical ingredients
(API).
We
were
formed as a Delaware limited liability company in November 2001 for the purpose
of providing customized computing and communications services and solutions
for
small to medium-sized businesses. On August 24, 2005, we were converted into
a
Delaware corporation and changed our name from Southridge Technology Group,
LLC
to Southridge Technology Group, Inc. On July 13, 2007, we completed a reverse
merger, pursuant to which a wholly-owned subsidiary of ours merged with and
into
a privately held Delaware corporation engaged in the development and marketing
of generic pharmaceuticals, RxElite Holdings Inc., with the private company
being the surviving company. In connection with the reverse merger, we
discontinued our former business and succeeded to the business of RxElite
Holdings Inc. as our sole line of business. For financial reporting purposes,
RxElite Holdings Inc., and not us, is considered the accounting acquirer.
Accordingly, the historical financial statements presented and the discussion
of
financial condition and results of operations herein are those of RxElite
Holdings Inc. and do not include our historical financial results. Our July
13,
2007 merger is being accounted for as a reverse acquisition and recapitalization
of RxElite Holdings Inc. for financial accounting purposes. Consequently, the
assets and liabilities and the historical operations reflected in the financial
statements prior to the merger are those of RxElite Holdings Inc. and recorded
at the historical cost basis of RxElite Holdings, and the consolidated financial
statements after completion of the merger includes our assets and liabilities
and the assets and liabilities of RxElite Holdings Inc., historical operations
of RxElite Holdings Inc. and our operations from the closing date of the
merger.
On
October 29, 2007, we amended our certificate of incorporation to change our
name
to “RxElite, Inc.” from “Southridge Technology Group, Inc.” and to increase the
number of shares of authorized capital stock to 201,000,000, divided into two
classes: 200,000,000 shares of common stock, par value $0.001 per share, and
1,000,000 shares of preferred stock, par value $0.001 per share. Prior to the
amendment, the number of shares of authorized capital stock was 99,000,000,
divided into two classes: 98,000,000 shares of common stock, par value $0.001
per share, and 1,000,000 shares of preferred stock, par value $0.001 per share.
On
January 4, 2008, our wholly owned subsidiary, FineTech Pharmaceutical, Ltd.
(formerly known as RxElite Israel Ltd.), a company organized under the laws
of
the State of Israel (“FineTech Pharmaceutical”), entered into an asset purchase
agreement to acquire substantially all of the assets of FineTech Laboratories,
Ltd., a privately held company organized under the laws of the State of Israel
(“FineTech”) (the “FineTech Acquisition”). In connection with the FineTech
Acquisition, Dr. Arie Gutman, the sole owner of FineTech and currently the
president of FineTech Pharmaceutical, agreed not to engage in certain activities
that would be competitive with our or FineTech Pharmaceutical’s business and to
assign the right to receive royalties with respect to the sale of certain
pharmaceutical products to FineTech Pharmaceutical, Ltd.. On January 22, 2008
we
issued 18,632,383 shares of our common stock to Dr. Gutman in consideration
for his non-competition undertaking and assignment of royalty rights. Dr.
Gutman currently serves as President of FineTech Pharmaceutical,
Ltd.
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
2 - BASIS OF PRESENTATION
The
interim financial information of the Company as of September 30, 2008 is
unaudited. The accompanying condensed consolidated financial statements have
been prepared in accordance with generally accepted accounting principles
(“GAAP”) in the United States of America for interim financial statements.
Accordingly, they omit or condense footnotes and certain other information
normally included in financial statements prepared in accordance with GAAP.
The
accounting policies followed for quarterly financial reporting conform to the
accounting policies disclosed in Note 2 to the Notes to Financial Statements
for
the year ended December 31, 2007. In the opinion of management, all adjustments
that are necessary for a fair presentation of the financial information for
the
interim period reported have been made. All such adjustments are of a normal
recurring nature. The results of operations for the three and nine months ended
September 30, 2008 are not necessarily indicative of the results that can be
expected for the entire year ending December 31, 2008. The unaudited condensed
consolidated financial statements should be read in conjunction with the
Company’s audited financial statements and the notes thereto for the year ended
December 31, 2007.
NOTE
3 - GOING CONCERN
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. The Company has incurred losses
since inception and may continue to incur losses for the foreseeable future.
These conditions raise substantial doubt about the ability of the Company to
continue as a going concern. The Company’s business plan anticipates that its
immediate future activities will be funded from operations. The Company is
currently seeking strategic alternatives for future growth and continued
operations. These alternatives include but are not limited to the sale of a
subsidiary, joint venture, and/or sale of some or all of the Company to outside
groups.
Immediately
following the Merger, the Company raised $10,703,092 in gross proceeds of equity
capital and converted $1,899,273 of convertible debentures through the issuance
of 21,003,959 units in a private placement offering of its securities. In
addition, the Company received proceeds of $10,500,000 from the issuance of
a
senior secured convertible note on December 31, 2007. Further to these funds,
the Company received proceeds of $3,000,000 through a loan from a third party
represented by a second secured note issued on May 30, 2008.
If
sales
continue to be insufficient to support operations and planned development of
new
products, then the Company will need to access additional capital in the form
of
equity or debt. If public or private financing or suitable deal structures
to
create capital are not readily available or the terms are unacceptable, the
Company’s growth and revenue generating potential may be materially impaired.
Such results could have a material adverse effect on the Company’s financial
condition, results of operations and future prospects. The consolidated
financial statements do not include any adjustments that might result from
the
outcome of these uncertainties.
The
Company’s supplier of inventory, Minrad International, Inc. (hereinafter
“Minrad”), unilaterally removed exclusivity of supply on September 11, 2008.
Further, Minrad has ceased shipping product to the Company until the Company
remits full payment for amounts currently due, which is approximately $4.9M
(see
Note 9 for additional information). The Company is currently in discussions
with
Minrad to decide on an appropriate plan to move the Company forward and to
continue to supply the Company with product. Should the Company not be able
to
come to an agreeable plan with Minrad, the Company shall only be able to supply
its customers with product currently in inventory through the middle of January
2009. The lack of supply would materially impact the ongoing business of its
RxElite Holdings Inc. subsidiary. The consolidated financial statements do
not
include any adjustments that might result from the outcome of these
uncertainties.
NOTE
4 – ACCOUNTS RECEIVABLE
At
December 31, 2007, the Company’s accounts receivable was $494,762, net of
allowances for doubtful accounts and payment discounts of $4,092, and $3,914,
respectively. At September 30, 2008, the Company’s accounts receivable was
$987,229, net of allowances for doubtful accounts and payment discounts of
$11,496, and $21,417, respectively.
NOTE
5 – RELATED PARTY ACCOUNTS RECEIVABLE
At
December 31, 2007, the Company had an accounts receivable from a related party
of $465,378. The receivable was due from a key supplier, Minrad International.
The Company had received the full amount of this receivable through either
credit offsets to RxElite’s accounts payable due to Minrad or through the return
of third-party product to RxElite.
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
6 – FIXED ASSETS
RxElite,
Inc.
Assets
and depreciation as of September 30, 2008 and December 31, 2007 are as
follows:
|
|
September 30,
2008
|
|
December 31,
2007
|
|
Furniture,
Fixtures, and Office Equipment
|
|
$
|
172,313
|
|
$
|
163,945
|
|
Building
(in construction)
|
|
|
508,731
|
|
|
483,407
|
|
Computer
hardware and software
|
|
|
764,762
|
|
|
758,123
|
|
Product
(vaporizers and installation costs)
|
|
|
5,241,949
|
|
|
959,856
|
|
Gross
Fixed Assets
|
|
|
6,687,755
|
|
|
2,365,331
|
|
Accumulated
Depreciation
|
|
|
(1,626,352
|
)
|
|
(532,758
|
)
|
Total
Fixed Assets, Net
|
|
$
|
5,061,403
|
|
$
|
1,832,573
|
|
FineTech
Pharmaceutical, Ltd.
Assets
and depreciation as of September 30, 2008 are as follows:
|
|
September 30,
2008
|
|
Equipment
|
|
$
|
2,638,920
|
|
Furniture,
Fixtures, and Office Equipment
|
|
|
107,530
|
|
Building
|
|
|
283,100
|
|
Computer
hardware and software
|
|
|
28,400
|
|
Other
|
|
|
38,400
|
|
Gross
Fixed Assets
|
|
|
3,096,350
|
|
Accumulated
Depreciation
|
|
|
(334,404
|
)
|
Total
Fixed Assets, Net
|
|
$
|
2,761,946
|
|
Summary
:
|
|
September 30,
2008
|
|
December 31,
2007
|
|
Equipment
|
|
$
|
2,638,920
|
|
$
|
-
|
|
Furniture,
Fixtures, and Office Equipment
|
|
|
279,843
|
|
|
163,945
|
|
Building
(includes in construction)
|
|
|
791,831
|
|
|
483,407
|
|
Computer
hardware and software
|
|
|
793,162
|
|
|
758,123
|
|
Product
(vaporizers and installation costs)
|
|
|
5,241,949
|
|
|
959,856
|
|
Other
|
|
|
38,400
|
|
|
-
|
|
Gross
Fixed Assets
|
|
|
9,784,105
|
|
|
2,365,331
|
|
Accumulated
Depreciation
|
|
|
(1,960,756
|
)
|
|
(532,758
|
)
|
Total
Fixed Assets, net
|
|
$
|
7,823,349
|
|
$
|
1,832,573
|
|
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
7 – INTANGIBLE ASSETS
RxElite,
Inc.
Intellectual
property consists of a patent valued at $25,000 and an FDA approved “Abbreviated
New Drug Application” (ANDA) for the generic pharmaceutical Fluoxetine valued at
$50,000.
Patent
and ANDA acquisition and application costs are recorded at cost. Patent costs
are amortized over their remaining useful life, not to exceed their legal life.
ANDA acquisition and application costs are recorded at cost and their
value is periodically tested for impairment. At December 31, 2007, the Company
concluded that there was no impairment of this intangible asset.
Patent
and ANDA acquisition and application costs at September 30, 2008 and December
31, 2007 are as follows:
|
|
September 30,
2008
|
|
December 31,
2007
|
|
Patent
Costs
|
|
$
|
25,000
|
|
$
|
25,000
|
|
ANDA
Acquisition and Application Costs
|
|
|
50,000
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
Gross
Carrying Value
|
|
|
75,000
|
|
|
75,000
|
|
Less
Accumulated Amortization
|
|
|
(9,757
|
)
|
|
(7,806
|
)
|
|
|
|
|
|
|
|
|
Total
Intangible Assets
|
|
$
|
65,243
|
|
$
|
67,194
|
|
FineTech
Pharmaceutical, Ltd.
Intellectual
property consists of four active patents.
Patent
valuations at September 30, 2008 are as follows:
Gross
Carrying Value
|
|
$
|
5,547,600
|
|
Less
Accumulated Amortization
|
|
|
(310,414
|
)
|
|
|
|
|
|
Total
Intangible Assets
|
|
$
|
5,237,186
|
|
NOTE
8 – GOODWILL
Goodwill
represents the excess of the valuation of the assets purchased from FineTech
Laboratories, Ltd. The Company accounts for its goodwill in accordance with
Statement of Financial Accounting Standards No. 142 (SFAS 142)
Goodwill
and Other Intangible Assets
,
which
requires the Company to test goodwill for impairment annually or whenever events
or changes in circumstances indicate that the carrying value of an asset may
not
be recoverable, rather than amortize.
The
entire goodwill balance of $10,678,793 at September 30, 2008, which is not
fully
deductible for tax purposes due to the purchase being completed partially
through the exchange of stock, is related to the Company's acquisition of assets
from FineTech Laboratories, Ltd. completed on January 4, 2008. With the
acquisition of assets and employees from FineTech Laboratories, Ltd., the
Company gained the affect of FineTech Laboratories’ reputation for product
development in the industry. Furthermore, the Company gained renowned PhD staff
that have the ability to develop active pharmaceutical ingredients (APIs) and
solve complex issues within the industry.
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
8 – GOODWILL (CONT.)
The
provisions of SFAS 142 require that a two-step impairment test be performed
annually or whenever events or changes in circumstances indicate that the
carrying value of an asset may not be recoverable. The first step of the test
for impairment compares the book value of the Company to its estimated fair
value. The second step of the goodwill impairment test, which is only required
when the net book value of the item exceeds the fair value, compares the implied
fair value of goodwill to its book value to determine if an impairment is
required.
NOTE
9 – ACCOUNTS PAYABLE
At
June
30, 2008, the Company had an account payable to Minrad International, Inc.,
the
Company’s supplier of anesthetic gases, of approximately $7.1M. The payment
terms on the account were 180 days from the date of shipment. All amounts came
due during the quarter ended September 30, 2008. Due to cash constraints, the
Company returned product to its supplier in the amount of approximately $2.3M
to
reduce this liability during the quarter ended September 30, 2008 to
approximately $4.9M.
NOTE
10 – NOTES PAYABLE - RELATED PARTY
At
December 31, 2007, the Company had a note payable to a related party of
$100,000. The note is due on demand, and bears simple interest computed at
12%
per annum. On September 13, 2008, the holder of the Note provided written notice
for payment of the Note. Payment was requested to be made on or before December
12, 2008. At September 30, 2008, the Company continued to have this note payable
outstanding and had negotiated a payment plan with the holder of the note to
pay
equal installments over three months starting in November 2008.
NOTE
11 – PAYABLE TO FORMER PREFERRED STOCKHOLDERS
Pursuant
to a transaction entered into immediately following the Merger, the Company
is
obligated to offer to purchase from the former holders of the RxElite Holdings,
Inc.’s Series A Preferred Stock on/or before December 31, 2008 up to an
aggregate of 350,000 shares of the Company’s common stock at a price of $4.00
per share, or a total obligation of $1,400,000. In addition, the Company
recorded an additional contingency related to the late effectiveness for its
Registration Statement in the amount of approximately $190,000. The Company
has
recorded this obligation at its present value, using an interest rate of 11.25%
per annum. The present value of the payable to stockholders, recorded as a
current liability in the accompanying consolidated balance sheet, was $1,555,623
and $1,255,692 at September 30, 2008 and December 31, 2007, respectively. It
is
unlikely that the Company will have the funds necessary to honor this
commitment.
NOTE
12 - EQUITY TRANSACTIONS
Common
Stock
During
the quarter ended September 30, 2008, the Company had the following transactions
related to common stock:
On
September 24, 2008, the Company issued 389,854 shares of common stock to
employees and directors of the Company with a fair value of $46,782. The shares
were issued after certain employees and directors converted outstanding options
at a four to one ratio to stock purchase rights, as approved by the Board of
Directors on June 4, 2008. The shares issued represent those stock purchase
rights that were fully vested as of the end of the third quarter of
2008.
On
September 24, 2008, the Company issued 3,000,000 shares of restricted common
stock to four members of management after the Board of Directors cancelled
previously issued stock appreciation rights granted to those employees. The
shares will vest annually on June 3
rd
over a
four year period. The estimated value of the award is $360,000 based on a stock
price of $0.11 per share on the date of issuance.
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
12 - EQUITY TRANSACTIONS (CONT.)
Options,
Stock Appreciation Rights and Restricted Stock Units
During
the quarter ended September 30, 2008, the Company had the following transactions
related to options, stock appreciation rights and restricted stock
units:
On
August
8, 2008, each of the Company’s employees were offered the opportunity to convert
stock options to stock purchase rights on a four to one ratio, as approved
by
the Board of Directors on June 4, 2008. A majority of the employees chose to
convert stock options to stock purchase rights. As of August 7, 2008, the
employees held options to purchase approximately 6,200,000 shares of common
stock. Employees choose to convert the option to purchase 3,720,356 shares
of
common stock into 1,330,090 stock purchase rights with similar vesting terms.
The Company currently has options outstanding to purchase approximately
2,900,000 shares of common stock to employees. After converting to stock
purchase rights, the Company still has 940,237 unvested stock purchase rights
outstanding to employees. The conversion of stock options to stock purchase
rights was under a modification to prior awards wherein employees and directors
may convert four stock options into one stock purchase right with the same
vesting period. The value of the original award was higher than the modification
to the award and thus no incremental expense was recorded.
The
Company has adopted the provisions of Statement of Financial Accounting
Standards (“SFAS”) No. 123R, Share Based Payments, which requires companies to
measure the cost of employee services received in exchange for equity
instruments based on the fair value of those awards and to recognize the
compensation expense over the requisite service period during which the awards
are expected to vest. A stock based compensation expense for the above noted
and
previously issued stock options in the amount of $794,686 has been reflected
in
the accompanying financial statements for the nine month period ended September
30, 2008.
The
Company uses the Black-Scholes valuation model to estimate the grant date fair
value of its stock options, stock appreciation rights, and warrants. The model
requires various judgmental assumptions including estimated stock price
volatility, forfeiture rates and expected life.
Our
calculations of the fair market value of each stock-based award that was
granted, modified or calculated during the quarter ended September 30, 2008
used
the following assumptions:
Black-Scholes
Input
|
|
Average
Value
|
|
Risk-free
interest rate
|
|
|
4.70
|
%
|
Expected
life in years
|
|
|
4
|
|
Dividend
yield
|
|
|
0.00
|
%
|
Expected
volatility
|
|
|
168.40
|
%
|
The
following table summarizes the stock option, warrant, stock purchase rights,
and
stock appreciation rights activity during the nine months ended September 30,
2008:
|
|
Shares
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Black-Scholes Value
|
|
Outstanding,
beginning of year
|
|
|
48,068,303
|
|
$
|
0.91
|
|
$
|
0.63
|
|
Granted
|
|
|
9,923,667
|
|
$
|
0.38
|
|
$
|
0.27
|
|
Expired/Cancelled
|
|
|
(7,092,587
|
)
|
$
|
0.46
|
|
$
|
0.36
|
|
Exercised
|
|
|
(389,854
|
)
|
$
|
-
|
|
$
|
-
|
|
Outstanding,
end of year
|
|
|
50,509,529
|
|
$
|
0.88
|
|
$
|
0.63
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
|
|
|
40,104,959
|
|
$
|
0.91
|
|
$
|
0.64
|
|
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
13 – AMORTIZATION OF DEBT DISCOUNT
The
Company booked non-cash amortization of debt discount related mostly to the
December 31, 2007 convertible debt funding for the nine month period ended
September 30, 2008 in the amount of $3,932,513. The remaining amount of the
debt
discount related to the convertible debt funding will be amortized over the
next
five quarters at which time the convertible debt funding will mature. The amount
expensed to the debt discount account related to the amortization of the present
value of our obligation to our former preferred shareholders and the severance
payments due to our former CEO and CFO, Daniel Chen, was $156,593.
NOTE
14 – TERMINATION OF DEVELOPMENT AGREEMENT
In
March
2008, the Company executed an Acknowledgement regarding the termination of
an
agreement between the Company and Core Tech Solutions, Inc. to develop a
Fentanyl transdermal system. The outstanding accounts payable to Core Tech
was
$800,000 at December 31, 2007. As of the date of the Acknowledgement, the
Company no longer owed the amount to Core Tech. As a result, the Company
recognized other income in the amount of $800,000 for the quarter ended March
31, 2008.
Pursuant
to the agreement with Core Tech, the Company may have a contingent asset for
reimbursement of amounts previously paid to Core Tech in the amount of
$2,200,000. The amount of this contingency is not recorded on the financial
statements of the Company is it is dependent upon the occurrence of one or
more
future events. This amount will be reimbursed to the Company within three years
of FDA approval and commencement of sales of the Fentanyl transdermal system,
or
equivalent. However, the amount will not be reimbursed to the Company unless
Core Tech is able to sign an equivalent partnership agreement with an alternate
manufacturing and distribution entity prior to March 31, 2009.
On
May
30, 2008, the Company executed a Mutual Termination regarding the termination
of
an agreement between the Company and Alkem Laboratories, Ltd. The Company was
refunded a prepayment from Alkem Laboratories, Ltd. in the amount of $46,666.
As
a result, the Company recognized other income in the amount of $46,666 for
the
quarter ended June 30, 2008.
NOTE
15 – EARNINGS PER SHARE
The
computation of basic earnings (loss) per common share is based on the weighted
average number of shares outstanding during the period. The computation of
diluted earnings per common share is based on the weighted average number of
shares outstanding during the period plus the weighted average common stock
equivalents which would arise from the exercise of stock options and warrants
outstanding and the conversion of convertible debentures using the treasury
stock method and the average market price per share during the
period
.
A
reconciliation of the number of shares used in the computation of the Company’s
basic and diluted earnings (loss) per common share is as follows:
|
|
Three
Months Ended
|
|
Nine
Months Ended
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Weighted
average number of common shares outstanding
|
|
|
116,536,380
|
|
|
78,799,145
|
|
|
115,978,842
|
|
|
53,727,416
|
|
Dilutive
effect of options and warrants
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Weighted
average number of common shares outstanding, assuming dilution
|
|
|
116,536,380
|
|
|
78,799,145
|
|
|
115,978,842
|
|
|
53,727,416
|
|
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
15 – EARNINGS PER SHARE (cont.)
No
stock
options, stock appreciation rights, warrants, stock purchase rights or
restricted stock units are included in the computation of weighted average
number of shares for the nine months ended September 30, 2008 because the effect
would be anti-dilutive. At September 30, 2008, the Company had outstanding
stock
options, stock appreciation rights, warrants, stock purchase rights or
restricted stock units to purchase a total of 50,509,529 common shares that
could have a future dilutive effect on the calculation of earnings per share.
Furthermore, the Company has convertible note payable with a total of
176,470,588 shares of common stock, which assumes conversion as of September
30,
2008, underlying the note that could have a future dilutive effect on the
calculation of earnings per share.
NOTE
16 - SIGNIFICANT CUSTOMERS
During
the nine months ended September 30, 2008, RxElite recorded revenues from two
customers that approximated 32% and 14% of gross sales, respectively. During
the
nine months ended September 30, 2008, our subsidiary, FineTech Pharmaceutical,
recorded revenues from two customers that approximated 66% and 14% of gross
sales, respectively.
NOTE
17 - SIGNIFICANT SUPPLIERS
The
Company outsources all of its generic pharmaceutical manufacturing for its
own
label to outside sources. For the nine month period ended September 30, 2008,
RxElite’s largest suppliers accounted for approximately $6M and $3M or 67% and
30% of product purchases. For the nine months ended September 30, 2008, our
subsidiary, FineTech Pharmaceutical’s largest suppliers accounted for
approximately $76,000 and $32,000 or 34% and 14% of product
purchases.
NOTE
18 – LOSS ON NOTE CONVERSION
As
previously reported in our filings with the SEC, on December 31, 2007, we
entered into a securities purchase agreement with Castlerigg Master Investments
Ltd., pursuant to which we sold 5,594,033 shares of our common stock,
a 9.50% senior secured redeemable convertible note in the
principal amount of $10,500,000 (“Convertible Note”), a Series A warrant to
purchase up to 13,985,083 shares of our common stock (“Series A Warrant”), and a
Series B warrant to purchase up to 4,661,694 shares of our common stock (“Series
B Warrant”, and together with the Series A Warrant, “Warrants”) for
aggregate gross proceeds of $10,500,000 (“Securities Purchase Agreement”). To
secure our obligations under the Convertible Note, we granted the selling
stockholder a first priority perfected security interest in all of our assets
and properties, together with all of the assets and properties of RxElite
Holdings Inc., including the stock of RxElite Holdings Inc. On January 18,
2008, we entered into a letter agreement with the investor, pursuant to which
we
amended certain terms of the Convertible Note, the Series A Warrant and the
Series B Warrant.
The
Convertible Note matures on December 31, 2009, which date may be extended at
the
option of the note holder as described below. The entire outstanding principal
balance and any outstanding fees or interest are due and payable in full on
the
maturity date. The Convertible Note bears interest at the rate of 9.50% per
annum, which rate may be increased to 15% upon the occurrence of an event of
default, as described below. Interest on the Convertible Note is payable
quarterly beginning on April 1, 2008. We have made our first two interest
payments. The Company has notified the investor that it will not make its third
interest payment and the two parties are currently in confidential discussions.
Although events of default currently exist, the holder of the Convertible Note
has not demanded repayment as of the date of this filing.
As
of
September 30, 2008, we failed to satisfy the Higher EBITDA ratio and as a
result, the conversion price of the Convertible Note was adjusted downward
to
$0.0595 per share. Based upon the new conversion price, if the Convertible
Note were converted in full, we would be required to issue 176,470,588 shares
of
Common Stock to the holder of the Convertible Note. These new shares would
represent approximately 147% of our then outstanding shares of Common
Stock. Notwithstanding the new conversion price, under the terms of the
Note and Warrants, the investor cannot convert the Note or exercise any warrants
to the extent that such conversion or exercise would result in the investor
holding in excess of 4.99% of our outstanding common stock. Since the
investor presently holds 5,594,033 shares of our common stock, it could not
convert the Convertible Note for an amount that would exceed 379,254 shares,
based upon 119,705,157 shares outstanding prior to such
conversion.
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
18 – LOSS ON NOTE CONVERSION (cont.)
The
loss
on note conversion account recorded a loss due to the reduction in conversion
price for the first quarter in the amount of $5,265,729. In addition to the
adjustments to the conversion price for the first quarter ended March 31,
2008, under the terms of the Convertible Note, if we failed to record
consolidated EBITDA, as defined in the Convertible Note, of at least
(i) $1,000,000 for the fiscal quarter ending September 30, 2008, the
conversion price shall be reset to the lower of (A) the then current conversion
price or (B) 85% of the average
market
price, as defined in the Convertible Note, of the common stock at such
time. The estimated additional loss due to the reduction in conversion price
for
the third quarter is $5,904,252. This amount was adjusted after calculation
of
the estimated conversion price reduction amount to $0.0595 per share was
calculated pursuant to the Note. The additional non-cash expense was recorded
during the third quarter ended September 30, 2008 in accordance with EITF Issue
No. 00-27
Application
of EITF Issue No. 98-5 to Certain Convertible Instruments
.
As
of
September 30, 2008, we failed to satisfy both the Higher and Lower EBITDA ratio
and as a result, the Company is now in default of the terms of the Convertible
Note. Based upon the event of default, the Convertible Note may be redeemed
in
part or in full by the holder at a price equal to the greater of (i) the product
of (a) the conversion amount to be redeemed and (b) the redemption premium
and
(ii) the product of (a) the conversion rate with respect to such conversion
amount in effect at such time as the holder delivers an event of default
redemption notice and (b) the product of (1) the equity value redemption premium
and (2) the greatest closing sale price of the common stock during the period
beginning on the date immediately preceding such event of default and ending
on
the date the holder delivers the event of default redemption notice.
Furthermore, the Company now must pay an interest rate of 15% per annum until
the default is cured. The default may be cured and the interest rate adjusted
down to the original 9.50% per annum by meeting future EBITDA requirements.
There is no assurance that the Company will satisfy future EBITDA requirements.
The Note is secured by a lien and security interest on substantially all of
our
assets.
NOTE
19 – SUPPLEMENTAL STATEMENT OF CASH FLOW
Cash
payments for interest for continuing operations were $700,052 and $348,065
for
the nine month period ended September 30, 2008 and 2007, respectively. There
were no cash payments made for income taxes during either the nine month periods
ended September 30, 2008 or September 30, 2007.
During
the nine months ended September 30, 2008, the Company had the following non-cash
investing and financing activities that have not been previously disclosed
in
the accompanying Notes to the September 30, 2008 interim financial
statements:
·
|
Increased
fixed assets through the transfer of property from inventory in the
amount
of $4,005,090.
|
·
|
Issued
18,632,383 common shares, increased common stock by $18,632, increased
additional paid-in capital by $13,311,507, increased fixed assets
by
$3,096,350, increased inventory by $393,896, increased intangible
assets
by $5,547,600, decreased cash by $6,386,500 and increased goodwill
by
$10,678,793 for the purchase of the assets of FineTech Laboratories
(Note
8).
|
·
|
Issued
1,000,000 common shares, increased common stock by $1,000, increased
additional paid-in capital by $459,000, and increased prepaid expense
by
$460,000 for a consulting
agreement.
|
·
|
Issued
3,000,000 common shares, increased common stock by $3,000, increased
additional paid-in capital by $357,000, and increased prepaid expense
by
$360,000 for conversion of stock appreciation rights to restricted
common
stock.
|
·
|
Increased
debt discount by $55,848 and increased additional paid-in capital
by
$55,848 for the loss on note conversion rate change (Note
18).
|
RXELITE,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September
30, 2008
(Unaudited)
NOTE
20 - RECENT ACCOUNTING PRONOUNCEMENTS
Recently
issued FASB Statements or Interpretations, Securities and Exchange Commission
or
SEC Staff Accounting Bulletins, and AICPA Emerging Issue Task Force Consensuses
have either been implemented or are not applicable to the Company during the
current quarter.
NOTE
21 – INCOME TAXES – FIN48 DISCLOSURE
In
2005,
the Company filed income tax returns in the U.S. federal jurisdiction, and
in
the states of Idaho, Texas, Kansas, Kentucky and New York. With few exceptions,
the Company is no longer subject to U.S. federal, state and local, or non-U.S.
income tax examinations by tax authorities for years before 2004. Tax returns
for the states of New York, Kentucky and Kansas were filed for 2006. In 2007,
the Company filed income tax returns in the U.S federal jurisdiction, as well
as
the states of California, Colorado, Georgia, Illinois, Maryland, Missouri,
New
Jersey, North Carolina, Oklahoma, and Pennsylvania.
The
Company adopted the provisions of FASB Interpretation No. 48,
Accounting
for Uncertainty in Income Taxes
,
on
January 1, 2007. As a result of the implementation of Interpretation 48, the
Company recognized no increase in the liability for unrecognized tax benefits.
The Company has large losses and the only adjustments necessary will adjust
the
amount of net operating loss available to the Company. The 2006 tax return
reports a carryforward net operating loss amount of $3,749,242. This amount
needs to be adjusted to reflect a balance of 2,890,649. The Company will amend
the 2006 tax return to account for this difference.
At
December 31, 2007, there are no tax positions for which there is uncertainty
about the timing of any tax deductions. Because of the impact of deferred tax
accounting, other than interest and penalties, the disallowance of the shorter
deductibility period would not affect the annual effective tax rate but would
accelerate the payment of cash to the taxing authority to an earlier
period.
The
Company’s policy is to recognize interest accrued related to unrecognized tax
benefits in interest expense and penalties in operating expenses. During the
year ended December 31, 2007, the Company recognized approximately $13,576,
in
interest and penalties.
NOTE
22 - SUBSEQUENT EVENTS
Frank
Leo, who has been a member of our Board of Directors since February 7, 2008,
resigned effective November 6, 2008.
Item
2. Management’s Discussion and Analysis or Plan of
Operations
Results
of Operations
Three
Months Ended September 30, 2008 Compared to Three Months Ended September 30,
2007
.
|
|
Three Months Ended
September 30,
|
|
|
|
%
|
|
|
|
2008
|
|
2007
|
|
Change
|
|
Change
|
|
Sales
(Net of Discounts)
|
|
$
|
3,257,718
|
|
$
|
753,962
|
|
$
|
2,503,756
|
|
|
332
|
%
|
Cost
of Goods Sold (Net of Discounts)
|
|
|
2,951,207
|
|
|
623,446
|
|
|
2,327,761
|
|
|
373
|
%
|
Gross
Profit
|
|
$
|
306,511
|
|
$
|
130,516
|
|
$
|
175,995
|
|
|
135
|
%
|
Gross
Profit %
|
|
|
9.4
|
%
|
|
17.3
|
%
|
|
|
|
|
|
|
Sales
Net
sales
increased by $2,503,756 from $753,962 for the three months ended September
30,
2007 to $3,257,718 for the three months ended September 30, 2008. This increase
reflects the acquisition of assets of FineTech Laboratories and the opening
of
our subsidiary, FineTech Pharmaceutical, Ltd. as well as an increase in
customers and bottle volume for our Sevoflurane product line.
Cost
of Goods Sold
Cost
of
goods sold increased by $2,327,761 from $623,446 for the three months ended
September 30, 2007 to $2,951,207 for the three months ended September 30, 2008.
This increase reflects acquisition of assets and launch of our Sevoflurane
product line. In addition, the Company had additional depreciation attributed
to
cost of goods for installation and placement of vaporizers with our customer
base for a total of $429,053 in the third quarter ended September 30, 2008
as
compared to $77,027 in the third quarter ended September 30, 2007.
Gross
Profit
Gross
profit increased by $175,995 from $130,516 for the three months ended September
30, 2007 to $306,511 for the three months ended September 30, 2008. Gross profit
as a percentage of sales decreased for the three months ended September 30,
2008
resulting from a decrease in our average selling price to customers during
the
quarter, increase in buy-in discounts offered to new customers, and an increase
in depreciation attributed to Cost of Goods.
Operating
Expenses
Three
Months Ended September 30, 2008 Compared to Three Months Ended September 30,
2007
.
|
|
Three Months Ended
September 30,
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
Change
|
|
Change
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
Selling
Expenses
|
|
$
|
173,361
|
|
$
|
1,138,810
|
|
$
|
(965,449
|
)
|
|
-85
|
%
|
Salaries,
Wages and Benefits
|
|
|
2,018,858
|
|
|
408,627
|
|
|
1,610,231
|
|
|
394
|
%
|
Research
and Development
|
|
|
(16,714
|
)
|
|
895,755
|
|
|
(912,469
|
)
|
|
-102
|
%
|
General
and Administrative Expenses
|
|
|
957,644
|
|
|
632,714
|
|
|
324,930
|
|
|
51
|
%
|
Amortization
Expense
|
|
|
150,807
|
|
|
650
|
|
|
150,157
|
|
|
23101
|
%
|
Depreciation
Expense
|
|
|
177,751
|
|
|
60,629
|
|
|
117,122
|
|
|
193
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Operating Expenses
|
|
$
|
3,461,707
|
|
$
|
3,137,185
|
|
$
|
324,522
|
|
|
10
|
%
|
Selling
Expense (Sales & Marketing)
Sales
and
marketing expense decreased by $965,449 from $1,138,810 for the three months
ended September 30, 2007 to $173,361 for the three months ended September 30,
2008. This decrease in sales and marketing expenses was a result of
reclassification in the 2008 financial statements of approximately $850,000
from
a selling expense to the salaries, wages and benefits account. This
reclassification for the quarter ended September 30, 2008 was partially offset
by an increase in selling expenses related to higher attendance at trade shows
and training requirements of newly hired sales staff.
Salaries,
Wages and Benefits
Salaries,
wages and benefits increased by $1,610,231 from $408,327 for the three months
ended September 30, 2007 to $2,018,858 for the three months ended September
30,
2008. The increase in salaries, wages and benefits in the three months ended
September 30, 2008 compared to the three months ended September 30, 2007 was
due
to an increase in salaries, wages and benefits as a result of the launch of
generic Sevoflurane and related increased operating activities. Further, the
increase was a result of opening our subsidiary, FineTech Pharmaceutical, in
Israel after our recent asset acquisition, as well as a reclassification from
the selling expense account as noted above.
Research
and Product Development
Research
and development, or product development expenses for the three months ended
September 30, 2008 decreased by $912,469 from $895,755 for the three month
period ended September 30, 2007 to a credit of $16,714 for the three month
period ended September 30, 2008. The decrease in research and development was
due to the termination of the Core Tech agreement in the period ended March
31,
2008 and the Alkem agreement in the period ended June 30, 2008, which were
in
effect during the prior year. This amount was partially offset by costs incurred
for research and development conducted by our subsidiary.
General
and Administrative
General
and administrative expenses increased by $324,930 from $632,714 for the three
months ended September 30, 2007 to $957,644 for the three months ended September
30, 2008. These increases were driven by the increase in new employee costs
related the launch of generic Sevoflurane, professional fees and expenses
related to our asset acquisition, professional fees and expenses related to
operating as a public company, and the addition of board of director fees and
expenses.
Amortization
Amortization
expense increased $150,157 from $650 for the three months ended September 30,
2007 to $150,807 for the three months ended September 30, 2008. This amount
was
due to the increase in intangible assets acquired by our subsidiary, FineTech
Pharmaceutical, Ltd., as well as the amortization of capitalized costs related
to our debt financing incurred December 31, 2007.
Depreciation
Depreciation
expense increased $117,122 from $60,629 for the three months ended September
30,
2007 to $177,751 for the three months ended September 30, 2008. The increase
was
due to the increase in assets acquired by our subsidiary, FineTech
Pharmaceutical, Ltd.
Other
Income (Expenses)
Three
Months Ended September 30, 2008 Compared to Three Months Ended September 30,
2007
.
|
|
Three Months Ended
September 30,
|
|
|
|
%
|
|
|
|
2008
|
|
2007
|
|
Change
|
|
Change
|
|
Other
Income (Expenses):
|
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
$
|
15,169
|
|
$
|
11,189
|
|
$
|
3,980
|
|
|
36
|
%
|
Interest
expense and penalties
|
|
|
(521,385
|
)
|
|
(11,483
|
)
|
|
(509,902
|
)
|
|
4440
|
%
|
Loss
on Debt Restructuring
|
|
|
-
|
|
|
(170,000
|
)
|
|
170,000
|
|
|
-100
|
%
|
Amortization
of debt discount
|
|
|
(1,364,390
|
)
|
|
-
|
|
|
(1,364,390
|
)
|
|
n/a
|
|
Loss
on note conversion rate change
|
|
|
(5,904,253
|
)
|
|
-
|
|
|
(5,904,253
|
)
|
|
n/a
|
|
Loss
on asset deposit
|
|
|
(46,484
|
)
|
|
-
|
|
|
(46,484
|
)
|
|
n/a
|
|
Other
income (expense)
|
|
|
10,777
|
|
|
13,946
|
|
|
(3,169
|
)
|
|
-23
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Other Expenses
|
|
$
|
(7,810,566
|
)
|
$
|
(156,348
|
)
|
$
|
(7,654,218
|
)
|
|
4896
|
%
|
Interest
Income
Interest
income increased by $3,980 from $11,189 for the three month period ended
September 30, 2007 to $15,169 for the three month period ended September 30,
2008. The increase was due to higher levels of interest-bearing deposits during
the quarter as a result of an inflow of cash from our $3M note payable agreement
with NPIL Pharma in the second quarter of 2008.
Interest
Expense and Penalties
Interest
expense increased by $509,902 from $11,483 for the three month period ended
September 30, 2007 to $521,385 for the three month period ended September 30,
2008. The increase is due to the quarterly interest payments of $249,375 at
9.50% to Castlerigg Investments, Ltd. related to our convertible debt acquired
on December 31, 2007 for the first two quarters, as well as an accrual of the
third interest payment at 15% in the amount of $393,750. There are five
additional quarterly interest payments due related to the convertible debt
financing.
Amortization
of Debt Discount
Amortization
of debt discount increased by $1,364,390 from $0 for the three month period
ended September 30, 2007 to $1,364,390 for the three month period ended
September 30, 2008. The increase is due to the amortization of the present
value
discount related to our convertible debt acquired on December 31, 2007, present
value discount of our obligation to former preferred shareholders, and present
value discount related to the severance obligation to our former CEO and CFO,
Daniel Chen.
Loss
on Note Conversion Rate
As
of
March 31, 2008, we failed to satisfy the EBITDA ratio of our Convertible Note
and, as a result, the conversion price of the Convertible Note was adjusted
downward to $0.22 per share. A further reduction in the conversion price
was required as of September 30, 2008 to approximately $0.06 per share. Based
upon the new conversion price, if the Convertible Note were converted in full,
we would be required to issue 176,470,588 shares of Common Stock to the holder
of the Convertible Note. These new shares would represent approximately
147% of our then outstanding shares of Common Stock.
Notwithstanding
the new conversion price, under the terms of the Note and Warrants, the investor
cannot convert the Note or exercise any warrants to the extent that such
conversion or exercise would result in the investor holding in excess of 4.99%
of our outstanding common stock. Since the investor presently holds
5,594,033 shares of our common stock, it could not convert the convertible
Note
for an amount that would exceed 379,254 shares, based upon 119,705,157 shares
outstanding prior to such conversion.
As
such,
the Company estimated the value of the convertible debenture based on the
amended terms of the Convertible Note during the third quarter of 2008. The
valuation will be performed on the seventh trading day following the filing
of
our Form 10-Q for the period ended September 30, 2008. An adjustment will be
made during the fourth quarter of 2008 to true up the original estimate, if
any.
The total non-cash expense related to the change in conversion rate was
allocated as follows: $5,904,252 to Loss on Note Conversion and $5,904,252
to
the equity component of the Note.
Changes
in the other income (expense) amounts not discussed above were not material
to
our operations.
Net
Loss
Net
loss
increased by $7,802,745 from net loss of $3,163,017 for the three months ended
September 30, 2007 to a net loss of $10,965,762 for the three months ended
September 30, 2008. The increase in our net loss for the third quarter of 2008
was due to non-recurring, non-cash expenses of approximately $7.3M related
to
the amortization of the debt discount and loss on note conversion related to
our
note with Castlerigg Master Investments, Ltd. Had these non-cash, non-recurring
items been eliminated, the net loss would have been comparable to the prior
year
despite significant increases in expenses.
Results
of Operations
Nine
Months Ended September 30, 2008 Compared to Nine Months Ended September 30,
2007
.
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
Change
|
|
Change
|
|
Sales
(Net of Discounts)
|
|
$
|
9,263,158
|
|
$
|
1,636,435
|
|
$
|
7,626,723
|
|
|
466
|
%
|
Cost
of Goods Sold (Net of Discounts)
|
|
|
7,898,368
|
|
|
1,322,945
|
|
|
6,575,423
|
|
|
497
|
%
|
Gross
Profit
|
|
$
|
1,364,790
|
|
$
|
313,490
|
|
$
|
1,051,300
|
|
|
335
|
%
|
Gross
Profit %
|
|
|
14.7
|
%
|
|
19.2
|
%
|
|
|
|
|
|
|
Sales
Net
sales
increased by $7,626,723 from $1,636,435 for the nine months ended September
30,
2007 to $9,263,158 for the nine months ended September 30, 2008. This increase
reflects the acquisition of assets of FineTech Laboratories and the opening
of
our subsidiary, FineTech Pharmaceutical, Ltd., as well as the launch of our
Sevoflurane product line in the second quarter of 2007.
Cost
of Goods Sold
Cost
of
goods sold increased by $6,575,423 from $1,322,945 for the nine months ended
September 30, 2007 to $7,898,368 for the nine months ended September 30, 2008.
This increase reflects acquisition of assets and launch of our Sevoflurane
product line. In addition, the Company had additional depreciation attributed
to
cost of goods for installation and placement of vaporizers with our customer
base for a total of $897,198 in the nine months ended September 30, 2008 as
compared to $77,027 for the nine months ended September 30, 2007.
Gross
Profit
Gross
profit increased by $1,051,300 from $313,490 for the nine months ended September
30, 2007 to $1,364,790 for the nine months ended September 30, 2008. Gross
profit as a percentage of sales decreased for the nine months ended September
30, 2008 resulting from a transition in product mix, increase in buy-in
discounts offered to new customers, and an increase in depreciation attributed
to Cost of Goods.
Operating
Expenses
Nine
Months Ended September 30, 2008 Compared to Nine Months Ended September 30,
2007
.
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
Change
|
|
Change
|
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
|
Selling
Expenses
|
|
$
|
521,166
|
|
$
|
2,374,544
|
|
$
|
(1,853,378
|
)
|
|
-78
|
%
|
Salaries,
Wages and Benefits
|
|
|
5,510,062
|
|
|
1,509,120
|
|
|
4,000,942
|
|
|
265
|
%
|
Research
and Development
|
|
|
(8,551
|
)
|
|
2,444,871
|
|
|
(2,453,422
|
)
|
|
-100
|
%
|
Product
Purchase Agreements
|
|
|
-
|
|
|
4,400,000
|
|
|
(4,400,000
|
)
|
|
-100
|
%
|
General
and Administrative Expenses
|
|
|
3,113,746
|
|
|
1,301,107
|
|
|
1,812,639
|
|
|
139
|
%
|
Amortization
Expense
|
|
|
398,327
|
|
|
1,951
|
|
|
396,376
|
|
|
20317
|
%
|
Depreciation
Expense
|
|
|
532,791
|
|
|
138,498
|
|
|
394,293
|
|
|
285
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Operating Expenses
|
|
$
|
10,067,541
|
|
$
|
12,170,091
|
|
$
|
(2,102,550
|
)
|
|
-17
|
%
|
Selling
Expense (Sales & Marketing)
Sales
and
marketing expense decreased by $1,853,378 from $2,374,544 for the nine months
ended September 30, 2007 to $521,166 for the nine months ended September 30,
2008. This decrease in sales and marketing expenses was a result of
reclassification in the 2008 financial statements of approximately $1.6M from
a
selling expense to the salaries, wages and benefits account. This
reclassification for the interim period ended September 30, 2008 was partially
offset by an increase in selling expenses related to higher attendance at trade
shows and training requirements of newly hired sales staff.
Salaries,
Wages and Benefits
Salaries,
wages and benefits increased by $4,000,942 from $1,509,120 for the nine months
ended September 30, 2007 to $5,510,062 for the nine months ended September
30,
2008. The increase in salaries, wages and benefits in the nine months ended
September 30, 2008 compared to the nine months ended September 30, 2007 was
due
an increase in salaries, wages and benefits due to the launch of generic
Sevoflurane and related increased operating activities. Further increase was
a
result of opening our subsidiary, FineTech Pharmaceutical, in Israel after
our
recent asset acquisition, as well as a reclassification from the selling expense
account.
Research
and Product Development
Research
and development, or product development expenses for the nine months ended
September 30, 2008 decreased by $2,453,422 from $2,444,871 for the nine month
period ended September 30, 2007 to a credit of $8,551 for the nine month period
ended September 30, 2008. The decrease in research and development was due
to
the termination of the Core Tech agreement in the period ended March 31, 2008
and the Alkem Laboratories agreement in the period ended June 30, 2008, which
were in effect during the period ended September 30, 2007. This amount was
partially offset by costs incurred for research and development conducted by
our
subsidiary
General
and Administrative
General
and administrative expenses increased by $1,812,639 from $1,301,107 for the
nine
months ended September 30, 2007 to $3,113,746 for the nine months ended
September 30, 2008. These increases were driven by the increase in new employee
costs related the launch of generic Sevoflurane, professional fees and expenses
related to our asset acquisition, professional fees and expenses related to
operating as a public company, and the addition of board of director fees and
expenses.
Amortization
Amortization
expense increased $396,376 from $1,951 for the nine months ended September
30,
2007 to $398,327 for the nine months ended September 30, 2008. This amount
was
due to the increase in intangible assets acquired by our subsidiary, FineTech
Pharmaceutical, Ltd. , as well as the amortization of capitalized costs related
to our debt financing incurred December 31, 2007.
Depreciation
Depreciation
expense increased by $394,293 from $138,498 for the nine months ended September
30, 2007 to $532,791 for the nine months ended September 30, 2008. The increase
was due to the increase in assets acquired by our subsidiary, FineTech
Pharmaceutical, Ltd.
Other
Income (Expenses)
Nine
Months Ended September 30, 2008 Compared to Nine Months Ended September 30,
2007
.
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
2008
|
|
2007
|
|
Change
|
|
Change
|
|
Other
Income (Expenses):
|
|
|
|
|
|
|
|
|
|
Interest
Income
|
|
$
|
42,153
|
|
$
|
50,578
|
|
$
|
(8,425
|
)
|
|
-17
|
%
|
Interest
expense and penalties
|
|
|
(1,278,106
|
)
|
|
(174,844
|
)
|
|
(1,103,262
|
)
|
|
631
|
%
|
Loss
on Debt Restructuring
|
|
|
-
|
|
|
(358,054
|
)
|
|
358,054
|
|
|
-100
|
%
|
Amortization
of debt discount
|
|
|
(4,089,106
|
)
|
|
-
|
|
|
(4,089,106
|
)
|
|
n/a
|
|
Loss
on note conversion rate change
|
|
|
(11,169,982
|
)
|
|
-
|
|
|
(11,169,982
|
)
|
|
n/a
|
|
Loss
on asset deposit
|
|
|
(46,484
|
)
|
|
-
|
|
|
(46,484
|
)
|
|
n/a
|
|
Termination
of development agreement
|
|
|
846,666
|
|
|
-
|
|
|
846,666
|
|
|
n/a
|
|
Other
income (expense)
|
|
|
2,409
|
|
|
13,387
|
|
|
(10,978
|
)
|
|
-82
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Other Expenses
|
|
$
|
(15,692,450
|
)
|
$
|
(468,933
|
)
|
$
|
(15,223,517
|
)
|
|
3246
|
%
|
Interest
Income
Interest
income decreased by $8,425 from $50,578 for the nine month period ended
September 30, 2007 to $42,153 for the nine month period ended September 30,
2008. The decrease is due to lower levels of interest-bearing deposits during
the first nine months.
Interest
Expense and Penalties
Interest
expense increased by $1,103,262 from $174,844 for the nine month period ended
September 30, 2007 to $1,278,106 for the nine month period ended September
30,
2008. The increase is due to the quarterly interest payments of $249,375 to
Castlerigg Investments, Ltd. related to our convertible debt acquired on
December 31, 2007 for the first two quarters of 2008 at 9.50%, as well as
interest accrual of $393,750 for the third quarter of 2008 at 15%. We have
made
the first two interest payments and accrued the third interest payment as noted
in Note 18. There are five additional quarterly interest payments due related
to
the convertible debt financing. The additional increase is due to the accrual
of
a penalty payment due to original investors in the amount of approximately
$190,000.
Amortization
of Debt Discount
Amortization
of debt discount increased by $4,089,106 from $0 for the nine month period
ended
September 30, 2007 to $4,089,106 for the nine month period ended September
30,
2008. The increase is due to the amortization of the present value discount
related to our convertible debt acquired on December 31, 2007, present value
discount of our obligation to former preferred shareholders, and present value
discount related to the severance obligation to our former CEO and CFO, Daniel
Chen.
Termination
of Development Agreement
Termination
of Development Agreement increased by $846,666 from $0 for the nine month period
ended September 30, 2007 to $846,666 for the nine month period ended September
30, 2008. The increase is due to the termination of agreements with Core Tech
Technologies, Ltd. and Alkem Laboratories, ltd. during the first nine months
of
the current year.
Loss
on Note Conversion Rate
As
of
March 31, 2008, we failed to satisfy the EBITDA ratio of our Convertible Note
and, as a result, the conversion price of the Convertible Note was adjusted
downward to $0.22 per share. A further reduction in the conversion price
was required as of September 30, 2008 to approximately $0.06 per share. Based
upon the new conversion price, if the Convertible Note were converted in full,
we would be required to issue 176,470,588 shares of Common Stock to the holder
of the Convertible Note. These new shares would represent approximately
147% of our then outstanding shares of Common Stock.
Notwithstanding
the new conversion price, under the terms of the Note and Warrants, the investor
cannot convert the Note or exercise any warrants to the extent that such
conversion or exercise would result in the investor holding in excess of 4.99%
of our outstanding common stock. Since the investor presently holds
5,594,033 shares of our common stock, it could not convert the convertible
Note
for an amount that would exceed 379,254 shares, based upon 119,705,157 shares
outstanding prior to such conversion.
As
such,
the Company estimated the value of the convertible debenture based on the
amended terms of the Convertible Note during the third quarter of 2008. The
valuation will be performed on the seventh trading day following the filing
of
our Form 10-Q for the period ended September 30, 2008. An adjustment will be
made during the fourth quarter of 2008 to true up the original estimate, if
any.
The total non-cash expense related to the change in conversion rate was
allocated as follows: $55,848 to Debt Discount, $11,169,982 to Loss on Note
Conversion and $11,225,830 to the equity component of the Note.
Changes
in the other income (expense) amounts not discussed above were not material
to
our operations.
Net
Loss
Net
loss
increased by $12,069,667 from net loss of $12,325,534 for the nine months ended
September 30, 2007 to a net loss of $24,395,201 for the nine months ended
September 30, 2008. The increase in our net loss for the current fiscal year
2008 was due to non-operating, non-cash expenses of approximately $15.1M related
to the amortization of the debt discount and loss on note conversion related
to
our note with Castlerigg Master Investments, Ltd. Had these non-cash,
non-operating items been eliminated, the net loss would have been less than
the
prior year despite significant increases in expenses.
Liquidity
and Capital Resources
As
of
September 30, 2008, we had current assets of $8,315,839, including cash and
equivalents of $1,348,216, accounts receivable of $987,229, inventory of
$5,172,498 and other current assets of $807,896. As of September 30, 2008,
we
had current liabilities of $11,753,181, consisting primarily of accounts payable
of $7,794,452, accrued rebates of $612,538, accrued interest expense of
$543,750, and accrued payroll expenses of $780,551, and notes payable to former
preferred shareholders of $1,555,623. As a result, at September 30, 2008, we
had
a working capital deficit of $3,437,342.
The
Company’s supplier of inventory, Minrad International, Inc. (hereinafter
“Minrad”), unilaterally removed exclusivity of supply on September 11, 2008.
Further, Minrad has ceased shipping product to the Company until the Company
remits full payment for amounts currently due, which is approximately $4.9M
(see
Notes 3 and 9 for additional information). The Company is currently in
discussions with Minrad to decide on an appropriate plan to resolve the dispute
and to continue to supply the Company with product. Should the Company not
be
able to come to an agreeable plan with Minrad, the Company shall only be able
to
supply its customers with product currently in inventory through the middle
of
January 2009. The lack of supply would materially impact the ongoing business
of
its RxElite Holdings Inc. subsidiary. The consolidated financial statements
do
not include any adjustments that might result from the outcome of these
uncertainties.
Net
cash
used in operating activities was $4,754,061 and $14,228,360 for the nine months
ended September 30, 2008 and 2007, respectively. The decrease in net cash used
in operating activities in the first nine months of the current year resulted
from increased reliance on our suppliers (increase in accounts payable), which
was partially offset by an increase in inventory and accounts
receivables.
Net
cash
used in investing activities was $6,703,834 and $689,998 for the nine months
ended September 30, 2008 and 2007, respectively. Cash used in investing
activities consisted primarily of purchases of assets through our subsidiary,
FineTech Pharmaceutical, Ltd. on January 4, 2008.
We
have
funded our operating losses primarily from proceeds from the sale of our common
stock and proceeds from the issuance of convertible debentures and notes payable
to related parties.
Net
cash
provided by financing activities was $2,692,527 and $12,914,278 for the nine
months ended September 30, 2008 is comprised mostly of funds received from
the
issuance of a note during the second quarter in the amount of $3,000,000. This
amount was partially offset by cash payments for principal related to a
severance agreement to our former CEO, Daniel Chen, who currently serves as
a
member of our Board of Directors.
Going
Concern Uncertainty
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. The Company has incurred losses
since inception and may continue to incur losses for the foreseeable future.
These conditions raise substantial doubt about the ability of the Company to
continue as a going concern. The Company’s business plan anticipates that its
immediate future activities will be funded from operations. The Company is
currently seeking strategic alternatives for future growth and continued
operations. These alternatives include but are not limited to the sale of a
subsidiary, joint venture, and/or sale of some or all of the Company to outside
groups.
Immediately
following the Merger, the Company raised $10,703,092 in gross proceeds of equity
capital and converted $1,899,273 of convertible debentures through the issuance
of 21,003,959 units in a private placement offering of its securities. In
addition, the Company received proceeds of $10,500,000 from the issuance of
a
senior secured convertible note on December 31, 2007. Although events of default
exist the Convertible Note, the holder nas not demanded repayment required
under
the Convertible Note. Further to these funds, the Company obtained additional
funds in the amount of $3,000,000 through a loan from a third party
represented by a second secured note issued on May 30, 2008.
If
sales
continue to be insufficient to support operations and planned development of
new
products, then the Company will need to access additional capital in the form
of
equity or debt. If public or private financing or suitable deal structures
to
create capital are not readily available or the terms are unacceptable, the
Company’s growth and revenue generating potential may be materially impaired.
Such results could have a material adverse effect on the Company’s financial
condition, results of operations and future prospects. The consolidated
financial statements do not include any adjustments that might result from
the
outcome of these uncertainties.
The
Company’s supplier of inventory, Minrad International, Inc. (hereinafter
“Minrad”), unilaterally removed exclusivity of supply on September 11, 2008.
Further, Minrad has ceased shipping product to the Company until the Company
remits full payment for amounts currently due, which is approximately $4.9M
(see
Notes 3 and 9 for additional information). The Company is currently in
discussions with Minrad to decide on an appropriate plan to resolve the
dispute and to continue to supply the Company with product. Should the
Company not be able to come to an agreeable plan with Minrad, the Company shall
only be able to supply its customers with product currently in inventory through
the middle of January 2009. The lack of supply would materially impact the
ongoing business of its RxElite Holdings Inc. subsidiary. The consolidated
financial statements do not include any adjustments that might result from
the
outcome of these uncertainties.
Critical
Accounting Estimates and Policies
Cash
and Cash Equivalents.
Cash and
cash equivalents include highly liquid investments with a maturity of three
months or less.
Accounts
Receivable.
We
record our accounts receivable at the original invoice amount less an allowance
for doubtful accounts and less any applicable difference between the wholesale
acquisition cost price and the negotiated contract price (rebate amount). We
also adjust the receivable amount for a discount allowance for timely payments.
An account receivable is considered to be past due if any portion of the
receivable balance is outstanding beyond its scheduled due date. On a quarterly
basis, we evaluate our accounts receivable and establish an allowance for
doubtful accounts, based on our history of past write-offs and collections,
and
current credit conditions. No interest is accrued on past due accounts
receivable. Payment discounts are recorded against sales at the end of each
period to the extent they remain eligible against the corresponding receivable.
Customers are given payment discounts of between 2% and 3% for making payments
within a range of 30 to 45 days.
Inventories.
Inventories
are stated at the lower of cost (first-in, first-out) or market. A reserve
for
slow-moving and obsolete inventory is established for all inventory deemed
potentially non-saleable by management in the period in which it is determined
to be potentially non-saleable. The current inventory is considered properly
valued and saleable. We concluded that there was no need for a reserve for
slow
moving and obsolete inventory at September 30, 2008.
Property
and Equipment.
Property
and Equipment are stated at cost less accumulated depreciation. Expenditures
related to repairs and maintenance that are not capital in nature are expensed
in the period incurred. Appropriate gains and or losses related to the
disposition of property and equipment are realized in the period in which such
assets are disposed. Depreciation is computed using the straight-line method
over the following estimated useful lives:
Category
|
|
Useful
Life
|
|
Furniture
and Fixtures
|
|
|
3-7
years
|
|
Computer
Equipment
|
|
|
3-5
years
|
|
Software
|
|
|
3
years
|
|
Machinery
and Equipment
|
|
|
5-10
years
|
|
Product
(vaporizers)
|
|
|
2-3
years
|
|
Revenue
Recognition.
We
recognize revenue from product sales when the goods are received by the
customer, resulting in the transfer of title and risk of loss. We sell our
products to some wholesalers at the wholesale acquisition cost price and to
some
wholesalers at a negotiated contract price. Upon sale to wholesalers who operate
based on the WAC price, the wholesale acquisition cost price less an allowance
for the difference between the wholesale acquisition cost price and the contract
price (rebate amount), is recorded based on the maximum calculated rebate amount
which is treated as a sales revenue offset. Upon sale of our product by the
wholesaler using the wholesale acquisition cost price, we are invoiced for
the
difference between the wholesale acquisition cost and the contract price and
create a credit note for the difference. The credit notes are then reconciled
with the sales revenue offset. Sales at negotiated contract prices, as opposed
to wholesale acquisition costs, are recognized at the negotiated contract
price.
FineTech
Pharmaceutical, Ltd. generates its revenues mainly from sales of chemical
compounds for the use in the manufacturing of pharmaceutical products and from
granting an exclusive right of supply. Revenues from chemical compounds are
recognized upon delivery in accordance with Staff Accounting Bulletin No. 104
"Revenue Recognition" ("SAB 104"), when persuasive evidence of an agreement
exists, delivery of the product has occurred, the fee is fixed or determinable
and collectibility is probable. The Company does not have any significant
obligations after delivery. Amounts received from granting exclusive rights
to
the manufacturing and production outputs are recognized throughout the terms
period. The Company also generates revenues from sales of professional services
including consulting. Service revenues are recognized as work is
performed.
Earnings
Per Share
.
We have
adopted the provisions of SFAS No. 128, “Earnings Per Share.” Basic earnings or
loss per share is computed by dividing income or loss (numerator) applicable
to
common stockholders by the weighted number of common shares outstanding
(denominator) for the period. Diluted earnings per share assumes the exercise
or
conversion of all dilutive securities.
Share
Based Payments.
We
use
the Black-Scholes valuation model to estimate the fair value of our stock
options and warrants. The model requires judgment in various assumptions,
including estimated stock price volatility, forfeiture rates and expected life.
Prior to our reverse merger on July 13, 2007, we were privately held and did
not
have an internal or external market for our shares and therefore we did not
have
sufficient information available to support an estimate of our stock’s expected
volatility and share prices.
Research
and Development Costs
.
All
costs related to research and development and product development are expensed
as incurred. These costs include labor and other operating expenses related
to
product development, as well as costs to obtain regulatory
approval.
Advertising.
We
expense advertising as incurred.
Accounting
Estimates
.
The
process of preparing financial statements in conformity with accounting
principles generally accepted in the U.S. requires the use of estimates and
assumptions regarding certain types of assets, liabilities, sales, and expenses.
Such estimates primarily relate to unsettled transactions and events as of
the
date of the financial statements. Accordingly, actual results may differ from
estimated amounts.
Concentration
of Credit Risk
.
Financial instruments that potentially subject us to concentration of credit
risk consist of cash accounts in financial institutions. Although the cash
accounts exceed the federally insured deposit amount, we do not anticipate
nonperformance by the financial institutions.
Shipping
and Handling
.
We
record shipping and handling expenses in the period in which they are incurred
and are included in the cost of goods sold.
Recent
Accounting Pronouncements
Recently
issued FASB Statements or Interpretations, Securities and Exchange Commission
or
SEC Staff Accounting Bulletins, and AICPA Emerging Issue Task Force Consensuses
have either been implemented or are not applicable to the Company during the
current quarter.
Item
3. Controls and Procedures
Evaluation
of disclosure controls and procedures
Rules
13a-15(e) and 15d-15(e) under the Exchange Act, require management to carry
out
an evaluation of the effectiveness of our Company's disclosure controls and
procedures as of the end of the period covered by this quarterly report, being
September 30, 2008. Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements. 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 policies or procedures may deteriorate.
The
Company's management, including the Chief Executive Officer and Principal
Financial Officer, assessed the effectiveness of the Company's internal control
over financial reporting as of September 30, 2008 in accordance with a
recognized framework. Based on that evaluation, management has concluded
that there are material weaknesses in our internal controls. A material weakness
is a deficiency, or a combination of deficiencies, in internal control over
financial reporting, such that there is a reasonable possibility that a material
misstatement of the Company's annual or interim financial statements will not
be
prevented or detected on a timely basis.
The
material weaknesses identified were (i) lack of segregation of duties, and
(ii)
lack of sufficient personnel and/or resources with generally accepted accounting
principals (GAAP) and tax accounting expertise. These control deficiencies
resulted in audit adjustments to the Company's 2007 annual financial statements.
Accordingly, management has determined that these control deficiencies
constitute material weaknesses.
Significant
changes in internal controls
There
have been significant changes in our Company's internal controls over financial
reporting that occurred during the period covered by this quarterly report
that
have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
The
changes were made to enhance and strengthen the financial reporting department
of the Company. The changes included additional finance and accounting
personnel, creation of documentation of policies and procedures for all levels
of employees that affect financial reporting, further segregation of duties
within the financial reporting department, and the retention of a SOX consulting
firm to assist with implementation and testing of controls and
procedures.
Although
the Company has made the changes noted above, it still believes that the
material weaknesses noted above exist. The Company will continue to improve
its
compliance in future quarters.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
The
Company is not involved or subject to any legal proceedings which could have
a
material adverse effect upon its operations or financial condition.
Item
1A.
Risk
Factors
In
addition to the other information set forth in this Form 10-Q, investors should
carefully consider the factors discussed in the “Risk Factors” section of our
Annual Report on Form 10-KSB for the year ended December 31, 2007, which could
materially affect our business, results of operations, financial condition
or
liquidity. The risks described in our Annual Report on Form 10-KSB for the
year ended December 31, 2007 have not materially changed, except as provided
below.
The
continuation of a low trading price of the Company’s common
shares.
The
Company’s common stock began trading on the OTC.BB at levels well below its
historical rates. The current economy is currently undergoing a period of
unprecedented volatility, and the future may continue to be unstable. The
economic instability has led, and could further lead, to reduced consumer
spending in the foreseeable future, including that on medical procedures that
utilize our pharmaceutical products. The Company’s sales could be
negatively affected if consumers continue to reduce spending on medical
procedures. In addition, reduced consumer spending may lead to further
price erosion in the marketplace for our products. These conditions may
adversely affect the Company’s industry, business and results of operations and
may cause the market value of our common stock to decline further.
We
continue to experience operating losses, working capital deficiencies and
negative cash flows from operations, and these losses and deficiencies may
continue in the future.
Our
recent operating losses may continue in the future and there can be no assurance
that our financial outlook will improve. For the years ended December 31,
2007, 2006 and 2005, our operating losses were $19,815,000, $4,905,000 and
$7,479,000, respectively. We generated a negative cash flow from operations
in
2007 of $24,891,000, however we generated positive flows of $2,509,000 and
negative flows of $148,000 in 2006 and 2005, respectively. Our results of
operations did not improve as we had anticipated during the current year. As
such, we have begun to implement a restructuring plan in order to preserve
our
cash flow and continue business operations. As of September 30, 2008, we have
outstanding debt represetnted by notes payable to third parties in the amount
of
$13,600,000, of which $13,600,000 is current due and payable.
The
Board
of Directors and management are exploring various alternatives to restructure
our debt and operations, including a sale of some or all of our assets or the
sale of the Company or subsidiary. Although we are continuing discussions with
our primary supplier, Minrad International, Inc. regarding the payable owed
to
them and the continuation of our supply agreement, as well as discussing
restructuring of our note payable to Castlerigg Master Investments, Ltd. in
the
principal amount of $10,500,000, there can be no assurance that these
discussions will be successful. In order to restructure our liabilities and
operations, it may be necessary for us to file for bankruptcy. In addition,
under the U.S. bankruptcy laws and regulations, three creditors can file a
petition to have us placed into bankruptcy. There can be no assurance that
we
would be successful in restructuring the Company or our financial condition
under any of the alternatives being considered.
Our
ability to continue as a going concern is subject to our ability to realize
a
profit and/or obtain funding from outside sources.
We
have
incurred losses since inception and may continue to incur losses for the
foreseeable future. If sales continue to be insufficient to support operations
and planned development of new products, then the Company will need to access
additional capital in the form of equity or debt. If public or private financing
or suitable deal structures to create capital are not readily available or
the
terms are unacceptable, the Company’s growth and revenue generating potential
may be materially impaired. Such results could have a material adverse effect
on
the Company’s financial condition, results of operations and future prospects.
The consolidated financial statements do not include any adjustments that might
result from the outcome of these uncertainties. We do not presently have any
offers from third parties to provide financing to us. Given the current
financial turmoil in the United States and worldwide economies, our ability
to
obtain third party financing, whether debt, equity or a combination, will be
difficult and may not be successful.
We
rely on Minrad International, Inc. as our sole supplier of our distributed
products, which could result in us not being able to obtain sufficient
quantities to meet our short-term needs.
All
the
products that we currently distribute are produced by Minrad International,
Inc.
These products are the source of all of our current sales. We are currently
unable to acquire sufficient quantities of our products from Minrad
International, Inc. without prepayment of the products. Minrad International
has
notified us that it believes we are in default of our agreement with them,
which
default we deny. In addition, we currently owe Minrad International
approximately $4.9M as of September 30, 2008. Manufacturers of our products
are
scarce and the current disruption of our relationship with Minrad could result
in our inability to meet demand for our products, which could lead to customer
dissatisfaction, damage our reputation, cause customers to cancel existing
orders and to stop doing business with us and could result in the cessation
of
our business. The Company is currently working with Minrad, who unilaterally
removed exclusivity from the distribution agreement, to continue shipping
product to us on a prepayment basis.
Our
obligations to the holder of our outstanding convertible note are secured by
all
of our assets. As a result of recent default on those obligations, the holder
of
such note could foreclose on our assets.
The
holder of our senior secured redeemable convertible note in the principal amount
of $10,500,000 (“Convertible Note”), has a security interest in all of our
assets and those of our subsidiary. As a result of our recent default our
obligations under the Convertible Note, the holder could foreclose its security
interests and liquidate some or all of our assets, which would cause substantial
material adverse harm our business, financial condition and results of
operations.
We
may issue additional shares of our common stock upon the redemption of the
Convertible Note or for our failure to meet certain performance targets, which
could result in our existing stockholders experiencing
dilution.
Since
the
Company failed to meet certain earnings targets commencing in the first fiscal
quarter of 2008 and more than 50% of the Convertible Note has not yet been
redeemed, the conversion price of the Convertible Note has been reset to the
lower of (i) the then current conversion price or (ii) 85% of the average market
price of our common stock at such time. This would lead to us issuing
substantially more shares of our common stock to the note holder at discounted
prices, which will lead to greater dilution of existing stockholders’ percentage
of ownership and voting power
The
risks
described in our Annual Report and above are not the only risks facing us.
Additional risks and uncertainties not currently known to us or that we
currently believe are immaterial also may materially adversely affect our
business, results of operations, financial condition or liquidity.
Item
2. Unregistered Sales of Equity Securities.
On
January 4, 2008, the Company issued 18,632,383 shares of common stock for a
total valuation of $13,330,139 for a non-competition undertaking and assignment
of royalty rights. These shares were issued to Dr. Arie Gutman, who currently
serves as President of our FineTech subsidiary.
On
February 7, 2008, the Company issued 1,000,000 shares of common stock to a
third-party consultant at forty-six cents ($0.46) per share for a total value
of
$460,000 for a consulting agreement.
On
September 24, 2008, the Company issued 389,854 shares of common stock to
employees and directors of the Company for vested stock purchase rights with
a
fair value of $46,782.
On
September 24, 2008, the Company issued 3,000,000 shares of restricted common
stock to four members of management after the Board of Directors cancelled
previously issued stock appreciation rights granted to those employees. The
estimated fair value of the award is $360,000 based on a stock price of $0.11
per share on the date of issuance.
With
respect to the foregoing transactions, the Company relied upon exemptions from
registration for the issuances of the securities provided under Section 4(2)
for
transactions not involving a public offering.
Item
3. Defaults Upon Senior Securities.
As
of
September 30, 2008, the Company failed to satisfy both the Higher and Lower
EBITDA ratios as required under our related to its Convertible Note with
Castlerigg Master Investments, Ltd. As a result, the Company is now in default
of the terms of the Convertible Note. As a result of the default, the holder
may
require the Company to redeem the Convertible Note in full. The holder has
not
exercised this right as of September 30, 2008. Based upon the event of
default, the Convertible Note may be redeem in part or in full by the holder
at
a price equal to the greater of (i) the product of (A) the conversion amount
to
be redeemed and (b) the redemption premium (principal and interested) and (ii)
the product of (a) the conversion rate with respect to such conversion amount
in
effect at such time as the holder delivers an event of default redemption notice
and (b) the product of (1) the equity value redemption premium and (2) the
greatest closing sale price of the common stock during the period beginning
on
the date immediately preceding such event of default and ending on the date
the
holder delivers the event of default redemption notice. Furthermore, as a result
of the default the Company must now accrue and pay an interest rate of 15%
per
annum until the default is cured. The default may be cured and the interest
rate
adjusted down to the 9.50% per annum by meeting future EBITDA
requirements.
Item
4. Submission of Matters to a Vote of Security Holders.
None.
Item
5. Other Information.
Dr.
Arie
Gutman, President of our subsidiary, FineTech Pharmaceutical, Ltd., provided
a
notice of resignation to the management of RxElite, Inc. during the third
quarter ended September 30, 2008. The notice does not take effect until June
2009. The Company is currently working with Dr. Gutman on a transition plan,
which includes Dr. Gutman continuing to meaningfully contribute to the
subsidiary’s day-to-day operations past the effective date of his
resignation.
Item
6. Exhibits.
(a)
Exhibits:
|
31.1
|
|
Certification
of principal executive officer pursuant to Rule 13a-14(a) of the
Securities Exchange Act of 1934, as amended, as adopted pursuant
to
Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2
|
|
Certification
of principal financial officer pursuant to Rule 13a-14(a) of the
Securities Exchange Act of 1934, as amended, as adopted pursuant
to
Section 302 of the Sarbanes-Oxley Act of
2002
|
|
32.1
|
|
Certification
of principal executive officer pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
32.2
|
|
Certification
of principal financial officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
SIGNATURES
In
accordance with the requirements of the Exchange Act, the Registrant caused
this
report to be signed on its behalf by the undersigned thereunto duly
authorized.
|
RXELITE,
INC.
|
|
|
|
Date: November
14, 2008
|
By:
|
/s/ Jonathan
Houssian
|
|
Jonathan
Houssian
|
|
President
and Chief Executive Officer
|
|
(Principal
Executive Officer)
|
|
|
Date: November
14
,
2008
|
By:
|
/s/
Shannon M. Stith
|
|
Shannon
M. Stith
|
|
Vice
President Finance
|
|
(Principal
Financial Officer)
|
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