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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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