YM BioSciences reports third quarter 2007 operational and financial results
MISSISSAUGA, ON, May 11 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), an oncology company that identifies, develops and commercializes
differentiated products for patients worldwide, today reported operational and
financial results for the third quarter of fiscal 2007, ended March 31, 2007.
"The quarter started with the unfortunate termination of our tesmilifene
trial, but continued with the advancement of our other two late-stage
products, announcing subsequent to the end of the quarter that our AeroLEF(TM)
phase IIb trial had met its primary endpoint and making progress with
nimotuzumab on several fronts within a global group of licensees," said David
Allan, Chairman and CEO of YM BioSciences. "We maintain a solid financial
position and remain committed to evaluating additional assets to enhance our
product pipeline while ensuring clinical momentum is sustained with our lead
products."
Nimotuzumab:
- During the quarter, global development of nimotuzumab through a number
of licensees and the licensor of the drug continued in multiple tumour
types, including pediatric and adult glioma, pancreatic cancer,
prostate cancer, non-small cell lung cancer, esophageal cancer,
cervical cancer, and breast cancer.
- Daiichi Sankyo Co., Ltd., the Japanese licensee of nimotuzumab, filed
and subsequent to the end of the quarter obtained the approval by
Japanese regulatory authorities of an IND application to start a
Phase I clinical trial of nimotuzumab for the treatment of solid
tumours.
- Enrollment is expected to be completed during the first half of 2007
in a Phase III trial of nimotuzumab as first-line therapy in pediatric
pontine glioma being conducted by Oncoscience AG in Germany.
- YM is in the planning stages of a Phase II study in the same
indication in the United States and Canada.
- YM anticipates filing an IND for a Phase II trial evaluating
nimotuzumab in colorectal cancer in the immediate future.
AeroLEF(TM):
- Subsequent to the end of the quarter, YM announced that AeroLEF(TM)
had met the primary endpoint in its randomized, placebo-controlled
Phase IIb trial enrolling opioid-na�ve patients with post-operative
pain following orthopedic surgery. AeroLEF(TM) demonstrated a
statistically significant difference in pain relief and pain intensity
to placebo (p(equal sign)0.0194).
- The results of this study will inform the design of YM's planned
Phase II trial for the U.S., for which an IND will be filed shortly,
as well as the design of the eventual Phase III trial.
Tesmilifene:
- In January 2007, the Data Safety Monitoring Board (DSMB) overseeing
the 'DEC' Phase III pivotal trial of tesmilifene in combination with
epirubicin and cyclophosphamide for the treatment of rapidly
progressing metastatic breast cancer completed the third planned
interim analysis. Evaluating data that included 351 patient events,
the DSMB advised the Company that, although there were no safety
concerns and that the trial was well conducted, it was highly unlikely
to meet its primary efficacy endpoint. Accordingly, YM terminated the
trial.
Financial Results (CDN dollars)
Total revenue for the quarter ended March 31, 2007 was $2.0 million
compared to $0.7 million for the same period last year. Total revenue for the
first nine months of the 2007 fiscal year was $5.7 million compared to
$1.5 million for the first nine months of the corresponding period last fiscal
year. Revenue increased as a result of two out-licensing agreements entered
into since March 31, 2006 and from increased interest income due to higher
cash balances. The larger out-licensing agreement, signed with Daiichi
Pharmaceutical Co., Ltd. in July 2006, for the commercial rights to
nimotuzumab for the Japanese market included a non-refundable up-front payment
from Daiichi to the Company of $14.6 million, net of withholding tax. The
gross amount of this initial license fee has been recorded as deferred revenue
and is being recognized over the estimated period of collaboration required.
Total operating expenditures for the quarter ended March 31, 2007 were
$10.9 million, which included a $1.8 million non-cash write-off of an
intangible asset, compared to $6.6 million for the same period last year.
Total expenditures for the first nine months of the 2007 fiscal year were
$31.0 million compared to $18.8 million for the first nine months of the
corresponding period last year. General and administrative expenses for the
third quarter were $1.7 million and for the first nine months were
$5.6 million compared with $1.9 million and $4.6 million respectively for the
same periods in the prior year. Licensing and product development expenses for
the third quarter were $7.3 million and for the first nine months were
$23.6 million compared to $4.7 million and $14.3 million respectively for the
same periods in the prior year.
The increases resulted primarily from increased salaries and bonuses due
to the addition of employees since May 2006. Also during the quarter, the
Company incurred expenses with respect to the termination of several
executives in February 2007. Total amortization with respect to intangible
assets totaled $0.4 million for the quarter compared to $0.3 million for the
same period in the prior year. Year-to-date intangible amortization charges
ended March 31, 2007 totaled $1.7 million compared to $0.8 million for the
same period in fiscal 2006.
Costs associated with development activities for nimotuzumab decreased by
$0.8 million for the quarter ended March 31, 2007 compared with the third
quarter of fiscal 2006. For the nine months ended March 31, 2007, costs
increased by $2.4 million over the corresponding period in fiscal 2006 as a
result of additional pre-clinical and clinical studies being conducted in
fiscal 2007 compared to fiscal 2006.
Costs associated with development activities for AeroLEF(TM) increased by
$0.3 million for the quarter ended and by $0.6 million for the nine months
ended March 31, 2007 over the respective corresponding periods in fiscal 2006
due to additional costs associated with the phase IIb clinical trial.
Costs related to development activities for tesmilifene for the three
month period ended March 31, 2007 increased to $2.9 million compared to
$2.7 million for the comparable period last year. Current costs for the
quarter mainly pertained to closing down the Phase III trial of tesmilifene
and the settlement of holdback amounts from the original contract of the
trial. Year-to-date costs decreased to $6.8 million compared to $8.7 million
for the same period in the prior year, as a result of reduced costs associated
with the Phase III clinical trial.
On February 1, 2007, the Company recorded an impairment for the
unamortized portion of the workforce intangible asset that was acquired in the
Eximias acquisition on May 9, 2006. After the termination of the Phase III
trial of tesmilifene, management re-evaluated the workforce intangible and
determined it to be impaired based on an analysis of the carrying value and
projected future cash flows of the asset. This resulted in a non-cash charge
of $1.8 million, the net book value of the asset on the day of impairment.
Net loss for the fiscal third quarter of 2007 was $8.9 million and for
the year to date was $27.0 million compared to $5.8 million and $17.2 million
respectively for the same periods last year.
As at March 31, 2007 the Company had cash, cash equivalents and
short-term deposits totaling $81.2 million and payables and accrued
liabilities totaling $3.7 million compared to $86.0 million and $2.1 million
at December 31, 2006 and $88.3 million and $3.7 million at June 30, 2006
respectively.
As at March 31, 2007 the Company had 55,835,356 common shares
outstanding. In addition, the Company had 2,380,953 common shares held in
escrow for contingent additional payment related to the acquisition of DELEX
Therapeutics Inc.; 8,972,277 warrants and 4,442,455 options outstanding.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and
commercializes differentiated products for patients worldwide. The Company has
two late-stage products: nimotuzumab, a humanized monoclonal antibody that
targets the epidermal growth factor receptor (EGFR) and is approved in several
countries for treatment of various types of head and neck cancer; and
AeroLEF(TM), a proprietary, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain.
This press release may contain forward-looking statements, which reflect
the Company's current expectation regarding future events. These
forward-looking statements involve risks and uncertainties that may cause
actual results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, but are not limited to,
changing market conditions, the successful and timely completion of clinical
studies, the establishment of corporate alliances, the impact of competitive
products and pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to time in the
Company's ongoing quarterly and annual reporting. Certain of the assumptions
made in preparing forward-looking statements include but are not limited to
the following: that nimotuzumab will continue to demonstrate a competitive
safety profile in ongoing and future clinical trials; and that YM and its
various partners will complete their respective clinical trials within the
timelines communicated in this release. We undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Summary financial statements attached:
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Balance Sheets
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
March 31, June 30,
2007 2006
-------------------------------------------------------------------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 11,187,001 $ 2,735,317
Short-term deposits 70,029,429 85,606,117
Accounts receivable 576,080 2,214,775
Prepaid expenses 256,288 318,338
-----------------------------------------------------------------------
82,048,798 90,874,547
Capital assets 349,397 304,985
Intangible assets 5,385,785 8,868,528
-------------------------------------------------------------------------
$ 87,783,980 $ 100,048,060
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 2,007,284 $ 2,367,042
Accrued liabilities 1,667,854 1,350,923
Deferred revenue 4,641,748 738,297
-----------------------------------------------------------------------
8,316,886 4,456,262
Deferred revenue 10,165,817 844,275
Shareholders' equity:
Share capital 172,921,153 172,771,544
Share purchase warrants 4,553,308 4,597,988
Contributed surplus 5,373,719 3,944,492
Deficit accumulated during the
development stage (113,546,903) (86,566,501)
-----------------------------------------------------------------------
69,301,277 94,747,523
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 87,783,980 $ 100,048,060
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Operations
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended
March 31,
2007 2006
-------------------------------------------------------------------------
(Unaudited)
Revenue $ 1,175,533 $ 498,861
Interest income 809,174 185,595
-------------------------------------------------------------------------
1,984,707 684,456
Expenses:
General and administrative 1,721,673 1,876,575
Licensing and product development 7,318,303 4,682,093
Impairment 1,829,538 -
-----------------------------------------------------------------------
10,869,514 6,558,668
-------------------------------------------------------------------------
Loss before the undernoted (8,884,807) (5,874,212)
Gain (loss) on foreign exchange (44,267) 101,733
Loss on sale of marketable securities - -
-------------------------------------------------------------------------
Loss before income taxes (8,929,074) (5,772,479)
Income taxes - -
-------------------------------------------------------------------------
Loss for the period $ (8,929,074) $ (5,772,479)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per common share $ (0.16) $ (0.13)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number of common shares
outstanding, excluding 2,380,953 common
shares held in escrow for contingent
additional payment related to the Delex
acquisition 55,819,986 44,009,338
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Nine months ended 1994 to
March 31, March 31,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Revenue $ 3,232,357 $ 966,611 $ 5,131,512
Interest income 2,505,559 510,082 7,395,408
-------------------------------------------------------------------------
5,737,916 1,476,693 12,526,920
Expenses:
General and administrative 5,553,538 4,558,347 34,661,737
Licensing and product
development 23,649,274 14,268,746 85,687,188
Impairment 1,829,538 - 1,829,538
-----------------------------------------------------------------------
31,032,350 18,827,093 122,178,463
-------------------------------------------------------------------------
Loss before the undernoted (25,294,434) (17,350,400) (109,651,543)
Gain (loss) on foreign
exchange (17,193) 117,783 (237,823)
Loss on sale of marketable
securities - - (1,191,329)
-------------------------------------------------------------------------
Loss before income taxes (25,311,627) (17,232,617) (111,080,695)
Income taxes 1,668,775 - 1,676,075
-------------------------------------------------------------------------
Loss for the period $ (26,980,402) $ (17,232,617) $(112,756,770)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per
common share $ (0.48) $ (0.42)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted average number of
common shares outstanding,
excluding 2,380,953 common
shares held in escrow for
contingent additional
payment related to the
Delex acquisition 55,794,483 40,613,971
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Deficit Accumulated During the
Development Stage
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended
March 31,
2007 2006
-------------------------------------------------------------------------
(Unaudited)
Deficit, beginning of period $(104,617,829) $ (72,212,032)
Cost of purchasing shares for cancellation
in excess of book value - -
Loss for the period (8,929,074) (5,772,479)
-------------------------------------------------------------------------
Deficit, end of period $(113,546,903) $ (77,984,511)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Nine months ended 1994 to
March 31, March 31,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Deficit, beginning of
period $ (86,566,501) $ (60,751,894) $ -
Cost of purchasing shares
for cancellation in
excess of book value - - (790,133)
Loss for the period (26,980,402) (17,232,617) (112,756,770)
-------------------------------------------------------------------------
Deficit, end of period $(113,546,903) $ (77,984,511) $(113,546,903)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Interim Consolidated Statements of Cash Flows
(Expressed in Canadian dollars)
-------------------------------------------------------------------------
Three months ended
March 31,
2007 2006
-------------------------------------------------------------------------
(Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (8,929,074) $ (5,772,479)
Items not involving cash:
Amortization of capital assets 27,410 16,151
Amortization of intangible assets 387,104 263,715
Impairment of intangible asset 1,829,538 -
Loss on sale of marketable securities - -
Stock-based employee compensation 440,965 644,676
Stock-based consideration -
Warrants-based consideration - 54,775
Change in non-cash operating working
capital:
Accounts receivable and prepaid
expenses 1,025,781 442,277
Accounts payable, accrued liabilities
and deferred revenue 391,221 1,417,075
-----------------------------------------------------------------------
(4,827,055) (2,933,810)
Financing activities:
Issuance of common shares on exercise of
warrants 87,500 2,912,559
Repayment of debenture - -
Net proceeds from issuance of shares and
warrants - 42,622,618
Issuance of common shares on exercise of
options 11,232 546,108
Redemption of preferred shares - -
Purchase of shares for cancellation - -
-----------------------------------------------------------------------
98,732 46,081,285
Investing activities:
Purchase of short-term deposits, net (4,494,783) (52,105,786)
Proceeds on sale of marketable securities - -
Additions to capital and intangible assets (54,244) (40,833)
-----------------------------------------------------------------------
(4,549,027) (52,146,619)
-------------------------------------------------------------------------
Increase (decrease) in cash and cash
equivalents (9,277,350) (8,999,144)
Cash assumed on acquisitions - -
Cash and cash equivalents, beginning of
period 20,464,351 20,300,992
-------------------------------------------------------------------------
Cash and cash equivalents, end of period $ 11,187,001 $ 11,301,848
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow information:
Non-cash items:
Issuance of shares from escrow on
Delex acquisition $ - $ -
Issuance of common shares on Eximias
acquisition - -
Issuance of common shares in exchange
for licensed patents - -
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Period from
inception on
August 17,
Nine months ended 1994 to
March 31, March 31,
2007 2006 2007
-------------------------------------------------------------------------
(Unaudited) (Unaudited)
Cash provided by (used in):
Operating activities:
Loss for the period $ (26,980,402) $ (17,232,617) $(112,756,770)
Items not involving cash:
Amortization of capital
assets 78,109 41,320 409,791
Amortization of
intangible assets 1,653,205 760,086 3,060,123
Impairment of
intangible asset 1,829,538 - 1,829,538
Loss on sale of
marketable securities - - 1,191,329
Stock-based employee
compensation 1,433,550 1,195,417 5,870,112
Stock-based
consideration - 100,000 292,750
Warrants-based
consideration - 54,775 54,775
Change in non-cash
operating working
capital:
Accounts receivable and
prepaid expenses 1,700,745 388,507 196,354
Accounts payable,
accrued liabilities
and deferred revenue 13,182,165 1,093,402 15,241,060
-----------------------------------------------------------------------
(7,103,090) (13,599,110) (84,610,938)
Financing activities:
Issuance of common shares
on exercise of warrants 89,375 3,098,474 4,371,555
Repayment of debenture - - (1,469,425)
Net proceeds from
issuance of shares and
warrants - 42,622,618 123,276,729
Issuance of common shares
on exercise of options 11,232 768,358 2,516,246
Redemption of preferred
shares - - (2,630,372)
Purchase of shares for
cancellation - - (1,029,679)
-----------------------------------------------------------------------
100,607 46,489,450 125,035,054
Investing activities:
Purchase of short-term
deposits, net 15,576,688 (22,223,314) (69,835,504)
Proceeds on sale of
marketable securities - - 1,404,450
Additions to capital and
intangible assets (122,521) (51,551) (572,674)
-----------------------------------------------------------------------
15,454,167 (22,274,865) (69,003,728)
-------------------------------------------------------------------------
Increase (decrease) in cash
and cash equivalents 8,451,684 10,615,475 (28,579,612)
Cash assumed on acquisitions - - 39,766,613
Cash and cash equivalents,
beginning of period 2,735,317 686,373 -
-------------------------------------------------------------------------
Cash and cash equivalents,
end of period $ 11,187,001 $ 11,301,848 $ 11,187,001
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Supplemental cash flow information:
Non-cash items:
Issuance of shares from
escrow on Delex
acquisition $ - $ 1,464,284 $ 11,326,981
Issuance of common
shares on Eximias
acquisition - - 35,063,171
Issuance of common
shares in exchange
for licensed patents - 100,000 100,000
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For further information: Thomas Fechtner, the Trout Group LLC, Tel. (212)
477-9007 x31, Fax (212) 460-9028, Email: tfechtner(at)troutgroup.com; James
Smith, the Equicom Group Inc., Tel. (416) 815-0700 x 229, Fax (416) 815-0080,
Email: jsmith(at)equicomgroup.com
(YMBA)
END
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