YM Biosciences reports 2006 year end operational and financial results
MISSISSAUGA, ON, Sept. 22 /CNW/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM,
AIM:YMBA), a company engaged in the acquisition, development and
commercialization of oncology and acute care products, today reported
operational and financial results for the fourth quarter and the 2006 fiscal
year, ended June 30, 2006.
"In fiscal 2006, we made exceptional progress in strengthening YM's
fundamentals. We move into fiscal 2007 with significant cash reserves and an
advanced product pipeline that has the prospect of yielding registration data
for both of our lead cancer drugs within the next 12-15 months," said David
Allan, Chairman and CEO of YM BioSciences. "The pivotal trial for tesmilifene,
our lead clinical candidate, has been the subject of two interim analyses of
safety and survival data which indicated the drug continues to be safe and the
trial continues to have the prospect of meeting its survival endpoint. A third
interim analysis is anticipated in the coming months, a fourth possibly in Q1
2007 and mature data during calendar 2007."
"For Nimotuzumab, data from numerous trials continue to demonstrate the
unique and competitive safety profile of this drug including an absence of the
side effects typically seen with other products in this drug class, notably
rash, severe diarrhea, conjunctivitis and hypomagnesemia. As this drug
progresses through a Phase III trial in pediatric glioma in Europe, these
properties could position nimotuzumab to become the EGFr-targeting drug best
suited for chronic use and we are encouraged by its having been approved, for
commercial use, by regulatory authorities in a number of countries," added
Mr. Allan.
Highlights of Fiscal 2006 (July 1, 2005 - June 30, 2006):
Tesmilifene
- Enrolment of 723 patients in the pivotal Phase III trial of
tesmilifene in metastatic and recurrent breast cancer was completed.
- FDA Fast Track designation for tesmilifene in advanced breast cancer
was received.
- A hypothesis of tesmilifene's mode of action authored by Dr. Mark
Vincent in Medical Hypotheses, Vol. 66 No. 4, was published.
- Positive results of a Phase II trial in hormone refractory prostate
cancer were published in the November 2005 issue of the Journal of
Urology.
- Collaborative agreement was signed with Sanofi-Aventis to investigate
the effect of combining tesmilifene and Taxotere(R) (docetaxel) for
treatment of women with rapidly progressing metastatic breast cancer.
Nimotuzumab
- YM's partner, Oncoscience AG, commenced patient treatment in a
Phase III trial in Germany with nimotuzumab. The trial is expected to
complete patient recruitment in the first half of calendar 2007. The
drug is also undergoing a Phase II monotherapy trial in Europe in
patients with advanced metastatic pancreatic cancer.
- Oncoscience AG presented updated positive data from a Phase II
monotherapy trial of nimotuzumab in children with resistant or
relapsed brain cancers at the International Society of Paediatric
Oncology conference on September 18, 2006.
- A multi-center Phase I/II trial comparing the effects of the
combination of nimotuzumab with radiation against radiation alone in
patients with non-small-cell lung cancer (NSCLC) unfit for
chemotherapy was initiated. Recruitment for the trial should be
completed in late calendar 2007 or early 2008. The trial is expected
to be expanded into South Korea through YM partner Kuhnil
Pharmaceutical Company of Seoul, Korea.
AeroLEF(TM)
- A randomized Phase IIb trial with AeroLEF(TM) for the treatment of
moderate to severe post-operative acute pain was initiated in 2006
and a preliminary report is expected in calendar Q4, 2006. YM intends
to continue development with the goal of initiating a Phase III trial
in the U.S. subject to positive Phase II data.
Other product highlights
- Clinical trial results for its anti-GnRH prostate cancer vaccine,
Norelin(TM), in hormone sensitive prostate cancer (HSPC) were
presented at the "Cancer Vaccines/Adjuvants/Delivery for the Next
Decade" conference in Lisbon, Portugal September 5-7, 2005.
- An exclusive worldwide license agreement with the University of
Saskatchewan for a portfolio of small molecule compounds that appear
to be highly potent enhancers of the activities of existing
chemotherapeutic treatments was completed.
Corporate highlights
- Licensed South Korean development and marketing rights for
nimotuzumab to Kuhnil Pharmaceuticals Ltd. of Seoul, South Korea.
- Licensed Southeast Asian and some African development and marketing
rights for nimotuzumab to Innogene Kalbiotech, a subsidiary of PT.
Kalbe Farma Tbk. of Jakarta, Indonesia.
- Licensed nimotuzumab, subsequent to the year-end, to Daiichi
Pharmaceutical Co., Ltd., a subsidiary of Daiichi Sankyo Company,
Limited, for the Japanese territory and received an up-front payment
of US$14.5 million and potentially significant milestone payments at
certain stages of development for each of a number of indications as
well as payments based on supply of nimotuzumab and sales performance
in the territory.
- Acquired Eximias Pharmaceutical Corporation, obtaining an experienced
senior management team and approximately US $29.5 million in cash.
- Raised US $40.1 million through a "registered direct" offering of
common shares.
- The Company's first "R&D Day" was held in New York for analysts and
portfolio managers.
Financial Results (all figures in Canadian dollars)
Total revenue for the fiscal year ended June 30, 2006 was $2.5 million
compared to $1.5 million for the fiscal year ended June 30, 2005. Total
revenue for the fourth quarter ended June 30, 2006 was $1.1 million compared
to $0.3 million for the same quarter last year. The increases were primarily
due to increased interest income resulting from the Company's significantly
larger short-term deposits compared with the previous year.
Total operating expenditures for the fiscal year ended June 30, 2006 were
$28.1 million compared to $17.3 million for the fiscal year ended June 30,
2005. Total operating expenditures for the fourth quarter ended June 30, 2006
were $9.3 million compared to $6.9 million for the same quarter in 2005.
General and Administrative expenses for the fiscal year ended June 30,
2006 were $8.0 million compared to $6.3 million for the fiscal year ended
June 30, 2005. General and Administrative expenses for the quarter ended
June 30, 2006 were $3.4 million compared to $2.3 million for the same quarter
in the prior year. General and Administrative expenses increased in 2006 over
2005 due principally to higher legal costs, stock-exchange and
investor-related costs and stock-based compensation expenses.
Licensing and Product Development expenses for the fiscal year ended
June 30, 2006 were $20.2 million compared to $11.0 million for the fiscal year
ended June 30, 2005. Licensing and Product Development expenses for the fourth
quarter ended June 30, 2006 were $5.9 million compared to $4.5 million for the
same quarter in 2005. Licensing and Product Development expenses increased
from 2005 due to the progression of the tesmilifene Phase III clinical trial,
development of the AeroLEF(TM) technology, increased out-licensing activity
and the inclusion of Eximias results for two months.
Net loss for the fiscal year and fourth quarter ended June 30, 2006 was
$25.8 million ($0.59 per share) and $8.6 million ($0.16 per share) compared to
$15.9 million ($0.47 per share) and $6.5 million ($0.18 per share)
respectively for the same periods last year.
On February 16, 2006, the Company raised gross proceeds of
US$40.1 million through a "registered direct" offering of common shares.
Subsequent to the end of the fiscal year, on July 25, 2006 the Company
entered into a License, Development, Manufacturing and Supply Agreement for
nimotuzumab. Under the terms of the agreement, the Company has received a
license fee of US$14,500,000. The agreement also entitles the Company to
receive milestone payments on the occurrence of events specified in the terms
of the contract and further payments based on the commercial sale of the
developed product. The license fee will be recognized over the term of the
related development collaboration.
As at June 30, 2006 the Company had 55,781,523 common shares outstanding,
2,380,953 common shares held in escrow for contingent additional payment
related to the acquisition of Delex Therapeutics Inc., 9,022,777 warrants, and
4,779,789 options.
AGM Announcement
YM BioSciences' Annual and Special Meeting of Shareholders will be held
on November 28th, 2006 at 4:00 p.m. at the Gallery of the TSX Broadcast &
Conference Centre, The Exchange Tower, 130 King Street West, Toronto, Ontario.
About YM BioSciences
YM BioSciences Inc. is engaged in the acquisition, development and
commercialization of oncology and acute care products.
Tesmilifene is a small molecule MDR-targeting agent that is being tested
in combination with various standard chemotherapy regimens for the treatment
of cancer. In addition to the Phase III DEC trial combining tesmilifene with
an anthracycline, a collaborative trial with Sanofi-Aventis is currently
ongoing combining tesmilifene with Taxotere(R) (docetaxel) a taxane drug. A
trial combining tesmilifene with epirubicin, cyclophosphamide, and 5-FU is
anticipated for the treatment of gastric cancer and additional trials are in
planning.
In addition, YM BioSciences is developing nimotuzumab, AeroLEF(TM) and
Norelin.
Nimotuzumab is an anti-EGFR humanized antibody that was recently
partnered in Japan with Daiichi Pharmaceutical Co., Ltd., a subsidiary of
Daiichi Sankyo Company, Limited Nimotuzumab was approved in India in July 2006
for the treatment of head & neck cancer, is currently in a Phase III trial in
Europe in combination with radiation for the treatment of pediatric pontine
glioma and a Phase I/II trial in a specific population of patients with
non-small cell lung cancer in Canada.
AeroLEF(TM) is a unique inhaled-delivery composition of free and liposome
encapsulated fentanyl, for the treatment of moderate to severe acute pain,
including cancer pain. AeroLEF(TM) is currently enrolling post-surgical
patients in a randomized Phase IIb trial.
Norelin, an anti-cancer vaccine, stimulates the immune system to develop
antibodies to gonadotropin-releasing hormone (GnRH). In addition, YM
BioSciences owns a portfolio of pre-clinical compounds.
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 the pivotal tesmilifene Phase III trial will be completed
on schedule and yield mature data in calendar 2007; that the DSMB's
recommendations to continue the pivotal trial for tesmilifene based on two
early analyses implies that the trial continues to have the prospect of
meeting its primary endpoint; that nimotuzumab will continue to demonstrate a
competitive safety profile in ongoing and future clinical trials; 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)
Consolidated Balance Sheets
(Amounts in Canadian dollars, unless otherwise noted)
June 30, 2006 and 2005
-------------------------------------------------------------------------
2006 2005
-------------------------------------------------------------------------
Assets
Current assets:
Cash and cash equivalents $ 2,735,317 $ 686,373
Short-term deposits 85,606,117 29,882,472
Marketable securities - 4,834
Accounts receivable 2,214,775 1,591,712
Prepaid expenses 318,338 159,661
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90,874,547 32,325,052
Capital assets 304,985 226,698
Intangible assets 8,868,528 5,648,141
-------------------------------------------------------------------------
$ 100,048,060 $ 38,199,891
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 2,367,042 $ 2,995,457
Accrued liabilities 1,350,923 830,158
Deferred revenue 738,297 206,770
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4,456,262 4,032,385
Long-term portion of deferred revenue 844,275 327,387
Shareholders' equity:
Share capital 172,771,544 87,487,802
Share purchase warrants 4,597,988 5,313,283
Contributed surplus 3,944,492 1,790,928
Deficit accumulated during the
development stage (86,566,501) (60,751,894)
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94,747,523 33,840,119
Basis of presentation
Commitments
Subsequent event
-------------------------------------------------------------------------
$ 100,048,060 $ 38,199,891
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YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statements of Operations and Deficit Accumulated During the
Development Stage
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
From
inception on
August 17,
1994
Years ended June 30, to June 30,
2006 2005 2004 2006
-------------------------------------------------------------------------
Revenue $ 1,151,135 $ 748,020 $ - $ 1,899,155
Interest
income 1,397,558 703,873 347,187 4,889,849
-------------------------------------------------------------------------
2,548,693 1,451,893 347,187 6,789,004
Expenses:
General and
admini-
strative 7,951,470 6,314,357 3,610,848 29,099,199
Licensing
and product
development 20,188,577 10,981,950 5,066,569 62,046,914
-----------------------------------------------------------------------
28,140,047 17,296,307 8,677,417 91,146,113
-------------------------------------------------------------------------
Loss before
the
undernoted (25,591,354) (15,844,414) (8,330,230) (84,357,109)
Loss on
foreign
exchange (220,630) - - (220,630)
Gain (loss) on
marketable
securities (2,623) - 638,332 (1,191,329)
Unrealized
loss on
marketable
securities - (14,881) - -
-------------------------------------------------------------------------
Loss before
income taxes (25,814,607) (15,859,295) (7,691,898) (85,769,068)
Income taxes - - - 7,300
-------------------------------------------------------------------------
Loss for the
period (25,814,607) (15,859,295) (7,691,898) (85,776,368)
Deficit,
beginning
of period (60,751,894) (44,319,267) (36,470,665) -
Cost of
purchasing
shares for
cancellation
in excess of
book value - (573,332) (156,704) (790,133)
-------------------------------------------------------------------------
Deficit, end
of period $ (86,566,501) $ (60,751,894) $ (44,319,267) $ (86,566,501)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and
diluted loss
per common
share $ (0.59) $ (0.47) $ (0.36)
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-------------------------------------------------------------------------
Weighted
average
number of
common shares
outstanding 43,755,160 34,046,450 21,353,479
Excludes
common shares
held in
escrow for
contingent
additional
payment
related to
the
acquisition
of Delex
Therapeutics
Inc. 2,380,953 2,777,778 -
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YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statements of Cash Flows
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
From
inception on
August 17,
1994
Years ended June 30, to June 30,
2006 2005 2004 2006
-------------------------------------------------------------------------
Cash provided
by (used in):
Operating
activities:
Loss for
the
period $ (25,814,607) $ (15,859,295) $ (7,691,898) $ (85,776,368)
Items not
involving
cash:
Depre-
ciation
of
capital
assets 61,017 11,717 14,910 331,681
Amorti-
zation of
intangible
assets 1,269,158 137,760 - 1,406,918
Unrealized
loss on
marketable
securities - 14,881 - 1,827,038
Loss (gain)
on
marketable
securities 2,623 - (638,332) (635,709)
Stock-based
compen-
sation 2,588,413 1,278,955 500,375 4,436,563
Stock-based
consider-
ation 100,000 192,750 - 292,750
Warrants-
based
consider-
ation 54,775 - - 54,775
Change in
non-cash
operating
working
capital:
Accounts
receivable
and
prepaid
expenses (672,639) (367,916) (295,651) (1,504,391)
Accounts
payable
and accrued
liabilities
and
deferred
revenue (1,599,032) 2,396,216 841,128 2,058,895
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(24,010,292) (12,194,932) (7,269,468) (77,507,848)
Financing
activities:
Repayment of
debentures - (1,469,425) - (1,469,425)
Issuance of
common shares
on exercise
of options 851,322 109,318 1,544,375 2,505,014
Issuance of
common shares
on exercise
of warrants 3,627,430 432,402 222,348 4,282,180
Redemption of
preferred
shares - - - (2,630,372)
Purchase of
shares for
cancellation - (779,909) (230,379) (1,029,679)
Net proceeds
from
issuance of
shares and
warrants 42,622,618 18,884,120 17,047,001 123,276,729
-------------------------------------------------------------------------
47,101,370 17,176,506 18,583,345 124,934,447
Investing
activities:
Short-term
deposits,
net (55,529,720) (14,988,521) (14,893,951) (85,412,192)
Proceeds on
sale of
marketable
securities 2,211 - 1,402,239 1,404,450
Additions to
capital and
intangible
assets (54,791) (27,034) (3,724) (450,153)
-------------------------------------------------------------------------
(55,582,300) (15,015,555) (13,495,436) (84,457,895)
-------------------------------------------------------------------------
Decrease in
cash and cash
equivalents (32,491,222) (10,033,981) (2,181,559) (37,031,296)
Net cash
assumed on
acquisition 34,540,166 5,226,447 - 39,766,613
Cash and cash
equivalents,
beginning of
period 686,373 5,493,907 7,675,466 -
-------------------------------------------------------------------------
Cash and cash
equivalents,
end of
period $ 2,735,317 $ 686,373 $ 5,493,907 $ 2,735,317
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Non-cash
items:
Issuance
of common
shares on
Delex
acqui-
sition $ 1,464,284 $ 9,862,697 $ - $ 11,326,981
Issuance of
common
shares on
Eximias
acquisition 35,063,171 - - 35,063,171
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For further information: Enquiries: 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