YM BIOSCIENCES REPORTS 2007 YEAR END OPERATIONAL AND FINANCIAL RESULTS
MISSISSAUGA, ON, Sept. 24 /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 fourth quarter and the 2007 fiscal year, ended
June 30, 2007.
"YM's business model, which unremittingly has been to diversify against
the risk of clinical failure, has made it possible for us to mitigate in part
just such an unfortunate event earlier this year with the disappointing
results of the tesmilifene trial. With recruitment in nimotuzumab's first
Phase III trial having been completed; the initiation of two additional late
stage trials this current quarter; with substantial international financial
and human resources supporting a broad and aggressive development program for
nimotuzumab; with AeroLEF(TM) having successfully completed its first
randomized trial and being prepared for its Phase III trials, we have seen the
benefits of adhering to our corporate strategy. This strategy permits us to
continue to take our late-stage products forward to surface their value," said
David Allan, Chairman and CEO of YM BioSciences. "Importantly, we start the
current fiscal year with more than US$65 million of cash available to support
our development programs."
Nimotuzumab:
Nimotuzumab, a humanized monoclonal antibody that targets the epidermal
growth factor receptor (EGFR), is currently in varying stages of development
in a number of trials, including colorectal cancer, adult and pediatric
glioma, non-small-cell lung cancer and pancreatic cancer. YM expects that the
range of indications will continue to broaden in 2008 as the group's
cooperative efforts expand. The drug is approved in a number of Latin American
countries as well as China and India.
Daiichi Sankyo Co., Ltd. in Japan, Oncoscience AG in Europe, Kuhnil
Pharmaceutical Co. in South Korea and Innogene Kalbiotech in Southeast Asia
have sub-licenses for nimotuzumab from CIMYM Inc., YM's majority-owned
subsidiary. Cooperative trials have already been initiated with some of
CIMYM's licensees and YM anticipates that the licensees will increasingly
participate cooperatively to accelerate the rate of recruitment into trials of
common interest, reducing the costs of development for each participant,
permitting rapid recruitment and shortening the time to completion of clinical
trials.
During Fiscal 2007:
- CIMYM BioSciences Inc. licensed the commercial rights for nimotuzumab
to Daiichi Sankyo Co., Ltd. for the Japanese market. The agreement
included a non-refundable up-front payment from Daiichi to the Company
of $16.2 million.
- YM BioSciences USA received clearance from the US Treasury Department
to import nimotuzumab into the US
- Daiichi Sankyo received clearance to initiate a clinical trial with
the drug in Japan.
- YM initiated enrollment for a Phase II colorectal cancer trial in
Canada. The first 50-patient cohort is expected to be completed in
calendar 2007 following which data on the primary endpoints, response
rate and safety, will be reported.
- YM received clearance to initiate a clinical trial in children with
inoperable recurrent, treatment-resistant brain cancer in Canada.
- YM reported successful regulatory review of the manufacturing of
nimotuzumab.
- YM reported preclinical data separately confirming that nimotuzumab
binds to the EGF receptor and that it also potentiates radiotherapy in
non-small-cell lung cancer cells.
Subsequent to the end of the fiscal year:
- YM USA was cleared by the US FDA to expand its second-line clinical
trial in children with inoperable, recurrent, treatment-resistant
brain cancer into the US
- Oncoscience AG reported completion of patient enrolment in the
Phase III, first-line, pediatric brain cancer trial.
- Oncoscience AG reported initiation of late-stage trials in adult
glioma and pancreatic cancer.
- YM reported positive preliminary results of a Phase I/II trial of
nimotuzumab in combination with radiation for the treatment of
non-small-cell lung cancer (NSCLC).
- The first 20 patients were recruited into the Phase II colorectal
trial by the date of this release.
AeroLEF(TM):
AeroLEF(TM) is a unique, inhaled-delivery composition of free and
liposome-encapsulated fentanyl in development for the treatment of moderate to
severe pain, including cancer pain. AeroLEF(TM) permits patients to identify
and select the appropriate dose in real-time for each pain episode to achieve
both rapid onset and extended duration of analgesia.
During Fiscal 2007:
- YM announced that AeroLEF(TM) had met the primary endpoint in its
first randomized, placebo-controlled Phase IIb trial enrolling opioid-
naive patients with post-operative pain following orthopedic surgery.
A statistically significant difference in pain relief and pain
intensity to placebo (p(equal sign)0.0194) was reported.
- YM received clearance from the FDA to initiate a Phase II trial in the
US in opioid tolerant or opioid-naive patients. A successful trial
would further extend the utility and medical breadth of the product if
and when approved. Enrollment in its 50-patient trial is expected to
start in calendar Q4, 2007.
- A request to the FDA for an End-of-Phase II meeting prior to calendar
year-end 2007 to discuss Phase III trial designs was designed and,
subsequent to the fiscal year-end, has been submitted.
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. YM terminated the trial
and, with the exception of one further follow-up for confirmation expected in
calendar Q4 2007 and the ongoing collaborative trial with Sanofi-Aventis in
metastatic breast cancer for which pharmacokinetic data should be available by
calendar year-end 2007, we intend to undertake no further clinical
development.
Financial Results (CDN dollars)
Total revenue for the fiscal year ended June 30, 2007 was $7.6 million
compared to $2.5 million for the fiscal year ended June 30, 2006. Total
revenue for the fourth quarter ended June 30, 2007 was $1.9 million compared
to $1.1 million for the same quarter last year.
Revenue from out-licensing increased by $3.3 million in fiscal 2007
compared to fiscal 2006 as a result of two out-licensing agreements entered
into during the year. The most significant agreement, signed with Daiichi
Pharmaceutical Co., Ltd. in July 2006, licensed the commercial rights for
nimotuzumab for Japan and included a non-refundable up-front payment from
Daiichi to the Company of $16.2 million. This initial license fee has been
recorded as deferred revenue and is being recognized over a period of four
years.
Interest income for fiscal 2007 increased by $1.8 million compared to
fiscal 2006, attributable to the significant increase in cash which resulted
from the US$40 million prospectus-based financing in February 2006, the
acquisition of Eximias Pharmaceutical Corporation in May 2006, and the
licensing payment from Daiichi Pharmaceutical Co., Ltd.
Total operating expenditures for the fiscal year ended June 30, 2007 were
$37.6 million compared to $28.1 million for the fiscal year ended June 30,
2006. Total operating expenditures for the fourth quarter ended June 30, 2007
were $6.5 million compared to $9.3 million for the same quarter in 2006.
General and administrative expenses decreased to $7.0 million in fiscal
2007 compared to $8.0 million in fiscal 2006. This was mainly due to a
decrease in stock based compensation expense of $872,000.
Licensing and product development expenses increased by $8.6 million from
$20.2 million in fiscal 2006 to $28.8 million in fiscal 2007. Costs associated
with development activities for nimotuzumab increased to $5.9 million compared
to $4.8 million in fiscal 2006 as a result of commissions and consulting fees
associated with obtaining the licensing agreement with Daiichi-Sankyo and
additional costs relating to pre-clinical and clinical studies. Costs
associated with development activities for AeroLEF(TM) decreased to
$2.9 million in fiscal 2007 compared to $4.1 million in fiscal 2006, mainly
due to decreased costs related to the Phase II trial in acute pain. Costs
related to development activities for tesmilifene for fiscal 2007 decreased to
$7.5 million in fiscal 2007 compared to $11.3 million in fiscal 2006, mainly
due to the closing down the Phase III trial and the settlement of holdback
amounts from the original contract for the trial.
Employee compensation relating to licensing and product development
increased by $5.2 million for fiscal 2007 compared to fiscal 2006. The
increase is partly attributed to salaries and bonuses related to employees who
joined YM as part of the Eximias acquisition in May 2006. Also, during the
year the Company incurred expenses with respect to the termination of certain
US executives in February 2007.
Total amortization with respect to intangible assets increased to
$1.9 million in fiscal 2007 compared to $1.3 million in fiscal 2006.
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 DEC
trial in metastatic breast cancer, management re-evaluated the workforce
intangible and determined it to be impaired because it is no longer a probable
future economic benefit. This resulted in a write-down of $1.8 million, the
net book value of the asset on the day of impairment.
Net losses for the fiscal year and fourth quarter ended June 30, 2007
were $31.7 million ($0.57 per share) and $4.7 million ($0.08 per share)
respectively compared to $25.8 million ($0.59 per share) and $8.6 million
($0.16 per share) for the same periods last year.
As at June 30, 2007 the Company had cash and cash equivalents and
short-term deposits totaling $75.6 million and payables and accrued
liabilities totaling $3.3 million compared to $88.3 million and $3.7 million
respectively at June 30, 2006.
As at June 30, 2007 the Company had 58,216,309 common shares outstanding,
of which 2,380,953 common shares are held in escrow for contingent additional
payment related to the acquisition of Delex Therapeutics Inc., 8,972,277
warrants, and 4,196,205 options.
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.
Conference Call Scheduled
A conference call is planned for 9:00am EDT, on Monday September 24,
2007, to which participants may listen via an audio webcast, accessible
through the company's website at www.ymbiosciences.com or via telephone. The
telephone conference number is 416-644-3414 or toll-free at 1-800-733-7560.
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; that AeroLEF(TM) will
continue to generate positive efficacy and safety data in 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)
Consolidated Balance Sheets
(Amounts in Canadian dollars, unless otherwise noted)
June 30, 2007 and 2006
-------------------------------------------------------------------------
2007 2006
-------------------------------------------------------------------------
Assets
Current assets:
Cash and cash equivalents $ 5,847,351 $ 2,735,317
Short-term deposits 69,724,438 85,606,117
Accounts receivable 370,011 2,214,775
Prepaid expenses 347,010 318,338
-----------------------------------------------------------------------
76,288,810 90,874,547
Property and equipment 325,040 304,985
Intangible assets 5,125,950 8,868,528
-------------------------------------------------------------------------
$ 81,739,800 $ 100,048,060
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 1,169,211 $ 2,367,042
Accrued liabilities 2,103,755 1,350,923
Deferred revenue 4,702,132 738,297
-----------------------------------------------------------------------
7,975,098 4,456,262
Deferred revenue 8,929,900 844,275
Shareholders' equity:
Share capital 172,921,153 172,771,544
Share purchase warrants 4,553,308 4,597,988
Contributed surplus 5,657,082 3,944,492
Deficit accumulated during the
development stage (118,296,741) (86,566,501)
-----------------------------------------------------------------------
64,834,802 94,747,523
Basis of presentation
Commitments
-------------------------------------------------------------------------
$ 81,739,800 $ 100,048,060
-------------------------------------------------------------------------
-------------------------------------------------------------------------
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)
-------------------------------------------------------------------------
Period from
inception on
August 17,
1994
Years ended June 30, to June 30,
2007 2006 2005 2007
-------------------------------------------------------------------------
Revenue $ 4,407,890 $ 1,151,135 $ 748,020 $ 6,307,045
Interest
income 3,239,540 1,397,558 703,873 8,129,389
-------------------------------------------------------------------------
7,647,430 2,548,693 1,451,893 14,436,434
Expenses:
General and
admini-
strative 6,978,336 7,951,470 6,314,357 36,086,535
Licensing
and product
development 28,758,469 20,188,577 10,981,950 90,796,383
Impairment of
intangible
assets 1,829,538 - - 1,829,538
-----------------------------------------------------------------------
37,566,343 28,140,047 17,296,307 128,712,456
-------------------------------------------------------------------------
Loss before
the under-
noted (29,918,913) (25,591,354) (15,844,414) (114,276,022)
Loss on
foreign
exchange (142,552) (220,630) - (363,182)
Loss on
marketable
securities - (2,623) (14,881) (1,191,329)
-------------------------------------------------------------------------
Loss before
income taxes (30,061,465) (25,814,607) (15,859,295) (115,830,533)
Income taxes 1,668,775 - - 1,676,075
-------------------------------------------------------------------------
Loss for
the period (31,730,240) (25,814,607) (15,859,295) (117,506,608)
Deficit,
beginning
of period (86,566,501) (60,751,894) (44,319,267) -
Cost of
purchasing
shares for
cancellation
in excess of
book value - - (573,332) (790,133)
-------------------------------------------------------------------------
Deficit,
end of
period $(118,296,741) $ (86,566,501) $ (60,751,894) $(118,296,741)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and
diluted loss
per common
share $ (0.57) $ (0.59) $ (0.47)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Weighted
average
number of
common
shares
outstanding 55,804,674 43,755,160 34,046,450
Excludes
common shares
held in
escrow for
contingent
additional
payment
related to
the
acquisition
of Delex
Therapeutics
Inc. 2,380,953 2,380,953 2,777,778
-------------------------------------------------------------------------
-------------------------------------------------------------------------
YM BIOSCIENCES INC.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Statements of Cash Flows
(Amounts in Canadian dollars, unless otherwise noted)
-------------------------------------------------------------------------
Period from
inception on
August 17,
1994
Years ended June 30, to June 30,
2007 2006 2005 2007
-------------------------------------------------------------------------
Cash provided
by (used in):
Operating
activities:
Loss for the
period $ (31,730,240) $ (25,814,607) $ (15,859,295) $(117,506,608)
Items not
involving
cash:
Deprecia-
tion of
property
and
equipment 107,107 61,017 11,717 438,789
Amortiza-
tion of
intangible
assets 1,913,040 1,269,158 137,760 3,319,958
Impairment
of
intangible
assets 1,829,538 - - 1,829,538
Loss on
sale of
marketable
securities - 2,623 14,881 1,191,329
Stock-based
compensa-
tion 1,716,913 2,588,413 1,278,955 6,153,476
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 1,816,092 (672,639) (367,916) 311,701
Accounts
payable
and accrued
liabilities
and
deferred
revenue 11,604,460 (1,599,032) 2,396,216 13,663,354
-------------------------------------------------------------------------
(12,743,090) (24,010,292) (12,194,932) (90,250,938)
Financing
activities:
Repayment of
debentures - - (1,469,425) (1,469,425)
Issuance of
common shares
on exercise
of options 11,232 851,322 109,318 2,516,246
Issuance of
common shares
on exercise
of warrants 89,375 3,627,430 432,402 4,371,555
Redemption of
preferred
shares - - - (2,630,372)
Purchase of
shares for
cancellation - - (779,909) (1,029,679)
Net proceeds
from issuance
of shares and
warrants - 42,622,618 18,884,120 123,276,729
-------------------------------------------------------------------------
100,607 47,101,370 17,176,506 125,035,054
Investing
activities:
Short-term
deposits,
net 15,881,679 (55,529,720) (14,988,521) (69,530,513)
Proceeds on
sale of
marketable
securities - 2,211 - 1,404,450
Additions to
property and
equipment and
intangible
assets (127,162) (54,791) (27,034) (577,315)
-------------------------------------------------------------------------
15,754,517 (55,582,300) (15,015,555) (68,703,378)
-------------------------------------------------------------------------
Increase
(decrease) in
cash and cash
equivalents 3,112,034 (32,491,222) (10,033,981) (33,919,262)
Net cash assumed
on acquisition - 34,540,166 5,226,447 39,766,613
Cash and cash
equivalents,
beginning of
period 2,735,317 686,373 5,493,907 -
-------------------------------------------------------------------------
Cash and cash
equivalents,
end of
period $ 5,847,351 $ 2,735,317 $ 686,373 $ 5,847,351
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Non-cash
items:
Issuance of
common
shares on
Delex
acquisi-
tion $ - $ 1,464,284 $ 9,862,697 $ 11,326,981
Issuance of
common
shares on
Eximias
acquisi-
tion - 35,063,171 - 35,063,171
Issuance of
common
shares in
exchange
for licensed
patents - 100,000 - 100,000
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;
Nominated Adviser, Canaccord Adams Limited, Ryan Gaffney, Tel. +44 (0)20 7050
6500
(YMBA)
END
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