NEWS Release
International
Wex Reports Results for the Fiscal Year Endend
March 2004
Company
Reports Clinical Trial Progress and Increase in Working Capital
Date: August 16, 2004
Toronto Stock Exchange
Trading Symbol: WXI
http://www.wextech.ca
E-mail: wex@wextech.ca
Vancouver, August 16, 2004
- International Wex Technologies Inc. (TSX: WXI) today reported
financial results for the year ended March 31, 2004 . The comparative
period for these statements is the 12 months ended March 31, 2003
. All amounts are in Canadian dollars unless otherwise specified.
OVERVIEW
"Our initiation of the pivotal
study of our lead product, Tectin™, for the management of cancer
pain combined with the strongest year end balance sheet in our corporate
history, makes WEX well positioned to rapidly develop our clinical
pipeline," said Frank Shum , Chairman and CEO of WEX. "Equally important,
we have a European corporate partner committed to commercializing
Tectin™ through a joint global development team, thus enabling us
to develop Tectin™ for North America , Europe and international
markets."
Financial Highlights
The Company issued approximately
9.6 million shares for aggregate net proceeds of $23.5 million which
included two significant private placements with institutional and
retail shareholders with combined proceeds of more than $16 million
dollars. The remaining funds were raised through the exercise of
stock options, warrants and other private placements.
In March 2004 the Company's
common shares commenced trading on the Toronto Stock Exchange.
Clinical Highlights
In February 2004, WEX completed
enrollment of its Canadian phase IIa study for the evaluation of
Tectin T in a multi-dose efficacy and safety study of patients with
severe cancer-related pain. Interim results were presented to the
medical community in November 2003 which demonstrated a clinically
meaningful response in 68% of cancer patients who failed to respond
to existing treatments. In May 2004 results were presented at the
Joint Meeting of the American Pain Society and the Canadian Pain
Society with findings consistent with the interim analysis.
In May 2004, a 150 patient
Canadian pivotal double-blind, placebo-controlled study of Tectin™
was initiated in cancer patients with refractory pain. Completion
of enrollment is expected to occur in the second half of calendar
2005. A blinded interim analysis by an independent Data Safety and
Monitoring Board ("DSMB") will occur when 50% of enrollment is completed.
Only blinded data will be reviewed and discussed by the DSMB. However,
in the event that efficacy or safety concerns arise and that unblinded
data can serve to assess the issues, the DSMB may request to review
unblinded study data. The Company will not issue a public announcement
of the interim analysis unless the safety board advises the Company
of any unexpected serious adverse events that may compromise the
conduct of the trial and the safety of the patients.
Product Highlights
The Company signed a licensing
agreement in March 2004 with a Canadian company for worldwide rights
to market Capsaicin Cream, (in mild, regular, and forte strength
formulations), a topical vanilloid compound to relieve neuralgia
and pain associated with osteoarthritis, rheumatoid arthritis and
diabetic neuropathy. A Drug Identification Number (DIN) for each
strength was issued under WEX's name from Health Canada in March
2004 which permits WEX to market the drug in Canada .
Sales of generic products
in 2004 declined from the previous year to $414,764 primarily from
sales in China . The decline in sales from fiscal 2003 was due to
closure of hospitals and clinics in China during the SARS crisis.
Recent trends indicate that sales have now stabilized. However,
while management works to reestablish its generic business, the
Company cannot reliably predict short term revenue from its generic
business.
Global Manufacturing
In March 2004, an agreement
was signed with a subsidiary of Sabex Holdings Ltd., to manufacture
WEX's clinical lots of Tetrodotoxin for Canada , the United States
and Europe. The agreement also provides Sabex with a first right
of refusal to acquire an exclusive license for WEX's injectable
products in Canada . Subsequent to the signing, the Company was
informed in June 2004 that Sabex Holdings Ltd. was acquired by Sandoz,
a Novartis AG Company. WEX's management was advised that the current
manufacturing and option agreement will remain in effect. Under
this agreement, WEX has access to a North American GMP facility
for manufacturing of its products. This agreement reduces regulatory
risk for North American and European jurisdictions. In addition,
management believes this contract manufacturing arrangement will
satisfy requirements of its existing corporate partner and other
potential licensing partners for an uninterrupted supply of cGMP-quality
clinical and commercial goods.
Corporate Highlights
During the fiscal year 2004,
the US Patent and Trade Office (USPTO) issued several patents to
the Company related to process, applications, and formulation for
its lead products derived from its Tetrodotoxin-based platform.
In May 2003, the Company
received a Notice of Allowance for the trademark Tetrodin™ from
the Canadian Intellectual Property Office and the USPTO. Tetrodin™
is the trademark name for the Company's drug in clinical testing
for addiction withdrawal from opioid abuse. Subsequently, the USPTO
issued Certificates of Registration and granted trademarks for Tetrodin
® and the Company's investigational pain medication, Tectin™.
Ernst & Young LLP Chartered
Accountants was appointed as the Company's auditor in March 2004.
Results of Operations
For the fiscal year end March
31, 2004 WEX recorded a net loss of $7,741,810 ($0.30 per common
share) versus a loss of $4,038,760 ($0.21 per common share) in the
prior fiscal year. The increase in loss is attributable to increased
research and development expenditures, higher stock-based compensation
as a result of adopting the fair value method of accounting for
employee options, and a decline in sales of generic products. All
results of operations other than the decline in sales of generic
products were in line with management expectations.
Revenue
Revenue from product sales
and license fees decreased to $731,304 for fiscal year 2004 from
$835,914 for fiscal 2003. Sales of generic products declined 43%
to $414,764. During the fiscal year 2003, WEX signed a licensing
agreement with Laboratorios del Dr. Esteve S.A. and received an
upfront net licensing payment of $1,582,700. The related withholding
taxes of $158,270 were expensed as incurred. This upfront payment
was recorded as deferred revenue and is being amortized over a 5
year period. No additional licensing income was received in the
fiscal year 2004.
The Company expects to receive
licensing fees and milestone payments in the future from existing
and potentially new collaborative arrangements. The extent and timing
of such additional licensing fees and milestones payments, if any,
will be dependent upon the overall structure of current and proposed
agreements and development progress of licensed technology, including
the achievement of development milestones by the Company's collaborative
partner(s). The Company expects to receive a milestone payment in
fiscal year 2005 from the Phase IIa study which completed enrollment
in Feb 2004, the results of which are not yet finalized. Other license
revenue will fluctuate from year to year and cannot be predicted.
Expenditures
The increase in research
and development expenditures in fiscal 2004 compared to fiscal 2003
is primarily due to the continued development of the Company's lead
product, Tectin™, which included clinical trial and related costs
associated with the Phase IIa study, preparation for additional
studies and investigator meetings. Included in research and development
expenses for the year ended March 31, 2004 is stock-based compensation
of $1,082,513 as compared to $nil for the year ended March 31, 2003.
General and administrative
expenses for fiscal 2004 were higher compared to fiscal 2003. Contributing
factors were stock-based compensation costs of $1,055,500 and legal,
listing and filing fees associated with the listing of the Company's
shares on the Toronto Stock Exchange. For fiscal 2005, a moderate
increase in general and administrative expenses is expected in support
of the Company's expanded research, product development and business
development operations and activities.
Amortization expense was
$491,969 for the year ended March 31, 2004 as compared to $390,413
for the prior year. The increase in amortization expense is related
to increases in capital assets including plant equipment, further
capitalization of patent fees, and the shortening of the amortization
period of intangible assets to 10 years from 17 years. The Company
believes that amortization expenses for fiscal 2005 will increase
over that of fiscal 2004 due to the amortization of additional capital.
Investment and Other
Income
Interest and Sundry income
in fiscal 2004 increased by $125,615 as a result of higher cash
balances throughout the year as compared to fiscal 2003.
A foreign exchange loss of
$170,469 was recorded during fiscal 2004 as compared to a foreign
exchange loss of $95,185 for fiscal 2003. Foreign exchange gains
and losses result from the translation of Hong Kong dollar-denominated
balances and transactions. The Company expects continued fluctuation
in the Canadian dollar, the Hong Kong dollar and the Chinese RMB
exchange rates during the 2005 fiscal year.
Liquidity and Capital
Resources
Since its incorporation,
WEX has financed its operations through the private sales of its
common shares, the exercise of warrants or options, licensing revenue
from its corporate partner, government tax credits and loans from
its founder and other directors. From its incorporation through
March 31, 2004 WEX had received approximately $47 million in net
proceeds from the issuance of its common shares.
At March 31, 2004 , WEX had
cash, cash equivalents and short-term investments of approximately
$18,300,000 as compared to $1,900,000 at March 31, 2003 . Cash used
in operations was $5,272,345 during the fiscal 2004 compared to
cash used in operations of $2,950,162 in the prior year. The current
period increase in cash used reflects increased expenditures in
research and development and general and administrative costs. Cash
used in investing activities increased to $10,506,844 from $1,401,107
in fiscal 2003. The increase relates to increased property, equipment
and patent expenditures and an increase in short-term investments.
Net cash provided by financing activities was $23,237,677 in fiscal
2004 compared to $4,635,809 in the same prior period. The increase
represents the increased equity financings discussed above.
Management believes that
the Company has sufficient cash to fund operations over the next
24 months. The use of proceeds is being allocated for funding of
ongoing and anticipated clinical trials, purchases of laboratory
equipment, upgrade of manufacturing processes, as well as general
corporate purposes including the hiring of additional research,
clinical and operating staff.
Subsequent Event
In June 2004, the Company's
wholly owned subsidiary, Wex Medical Limited, issued convertible
debentures in the aggregate principal amount of U.S. $5.1 million.
The debentures have a term of five years and carry an annual coupon
of 5.5% payable semiannually. The debentures may be convertible
at the option of the holders at any time until maturity into common
shares of WEX at a conversion price of $5.00 per share, with a bonus
of 4% of the face value of any of the debentures converted within
the first year. Wex may, at its option, force conversion of the
Debentures provided the daily closing price of common shares of
WEX equals or exceeds CDN $7.50 per share for 10 consecutive trading
days.
About Tectin™
Tectin™ is a drug designed
to treat moderate to severe pain, primarily through selective sodium
channel blockade. Tectin™ is being tested in a pivotal double-blind
placebo-controlled study in patients with refractory cancer pain.
Interim results from the Phase IIa clinical trial suggest that Tectin™
may have unique properties capable of combining rapid and lasting
analgesic effects without the morphine-like side effects characteristic
of many approved drugs for the management of moderate to severe
pain.
About International
Wex Technologies Inc.
International Wex Technologies
Inc. is a pharmaceutical company dedicated to the discovery of new
therapeutic agents for the treatment of moderate to severe pain,
symptom relief associated with addiction withdrawal from opioid
abuse, and medicines designed for local and regional anesthesia.
The Company's principle business strategy is to derive drugs from
naturally occurring toxins and develop proprietary products for
North American, European and international markets. The Company
also generates revenues from sales of generic products manufactured
at its facility in China .
Forward Looking Statement
Disclaimer
Statements in this news
release are forward-looking statements which may not be based on
historical fact, including without limitation statements containing
the words "believe", "may", "plan", "will", "estimate", "anticipates",
"intends", "expects" and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the 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, among others, WEX's stage of development, product revenues
which are difficult to predict, foreign currency exchange risk,
additional capital requirements, risks associated with the completion
of clinical trials, the ability to protect its intellectual property
and dependence on collaborative partners. These factors should be
considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements. The company disclaims
any obligation to update any such factors or to publicly announce
the result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments.
For additional information
on our products visit us at http://www.wextech.ca or call Gordon
Stanley, Corporate Communications at 604-683-8880, or at 1-800-722-7549.
Per: Donna Shum, Corporate
Secretary
The Toronto Stock
Exchange has not reviewed and does not accept responsibility for
the adequacy or accuracy of the content of this News Release.
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