TORONTO, April 30, 2007 (PRIME NEWSWIRE) -- Polydex Pharmaceuticals Limited (Nasdaq:POLXF) has announced the results for its fiscal year ended January 31, 2007. All figures are reported in US dollars.
Fiscal Year End 2007 Fiscal Year End 2006
--------------------- --------------------
Sales $ 6,499,287 $ 5,265,209
Net Loss (260,623) (1,489,053)
Earnings (loss) per
common share -
Basic (0.09) (0.49)
Diluted (0.09) (0.49)
Weighted average common
shares outstanding 3,063,884 3,052,296
A 23% increase in Sales in the fiscal year ended January 31, 2007, together with cost management and recognition of a deferred gain in a subsidiary, led to an 83% decrease in net loss in fiscal 2007 over the previous fiscal year.
In recent years, the Company has been experiencing an increase in demand for dextran-based products from its European customers. During fiscal 2007, Management determined that expansion of the Company's facility in Toronto should increase production capacity and also improve quality for a significant portion of the Company's powdered products. The Company therefore embarked upon a major plant refurbishment project that focused on the purchase and installation of more modern drying equipment with increased production capacity. Engineers prepared drawings and permits were issued, allowing construction of a new drying facility to begin in the fourth quarter of fiscal 2007, with completion projected for the second quarter of this fiscal year. Management expects that higher production capability will eventually lead to increased sales and that improved quality of the finished powdered products will result in new markets becoming available.
Ushercell, the Company's leading human pharmaceutical compound, is a cellulose sulphate gel envisioned as a method of contraception and potential prevention of the AIDS-causing virus HIV and other sexually transmitted diseases, and has been in development for over a decade in collaboration with CONRAD, a reproductive health consortium of the Eastern Virginia Medical School with support from USAID, FHI, the Bill and Melinda Gates Foundation, and others.
As a leading candidate in the field of microbicide development, Ushercell's development became part of increasing international focus on this important emerging field of science during fiscal 2007. Early in the year, ongoing progress in the large-scale Phase III clinical trials in India and in five African countries was presented in Cape Town, South Africa at the prestigious Microbicides 2006 conference.
The growing global fervour over microbicide development escalated this new prevention technology to the international spotlight at the AIDS 2006 conference in Toronto, Canada, where Polydex sponsored the innovative New Prevention Technologies Zone and gained further international press coverage.
Shortly thereafter, Ushercell was recognized and Polydex awarded Frost and Sullivan's 2006 North American Product Innovation of the Year Award.
In a strong year for the field of microbicide development, Polydex was then invited to participate in a special commemorative World AIDS Day event sponsored by the Nasdaq Stock Market, which included expert panel discussion on the AIDS pandemic and representation at the Closing Bell ceremony.
At the end of fiscal 2007, however, the Company announced that the Phase III trials had been halted due to an unexpected increase in HIV conversions at some of the clinical trial sites. A swift and complete closure of all ongoing trials was implemented with protection of the volunteer participants being the first priority.
The Ushercell Phase III efficacy studies were sponsored by CONRAD, and followed 11 earlier safety trials suggesting it was safe to use in women. But an interim review by the Data Safety Monitoring Board (DSMB) of trial data at three sites resulted in a recommendation to stop the trial early due to an unexpected rate of HIV conversion among the trial participants. A similar review of the Ushercell trial in Nigeria conducted by Family Health International (FHI) found no evidence of an increased risk there. The FHI and DSMB decided to err on the side of caution and closed that trial early as well.
No biological cause for this increased risk has yet been determined, and investigation continues to clarify the data, which may be useful in the development of future microbicide candidates. Various investigative review boards are amassing and evaluating data from the trial sites to determine the cause of the unexpected HIV conversions, and reports of their findings are expected in the fourth quarter of this fiscal year.
Following the promising results from a contraceptive efficacy trial announced early in 2006, Management is looking into methods of advancing Ushercell toward commercial viability as a contraceptive product. Directions are also being explored via the Scientific Advisory Board for ways to advance the further research and development of Ushercell for the potential treatment and prevention of a broad spectrum of potential indications including treatment of bacterial vaginosis and prevention of human papilloma virus.
Since Ushercell was not being marketed commercially and the Company received no financial payments from the project, suspension of the Ushercell Phase III trials has not impacted our existing sales or revenue, nor has it affected the strength of our daily business operations.
The key message from fiscal year 2007 is the ability of Polydex to maintain a steady progress with our core products and rise admirably to the opportunities presented through development of Ushercell, taking on the challenges inherent to our ambitions with this product.
A copy of the Company's Annual Report on Form 10-K, including its complete fiscal year end financial statements, is available at the company website at www.Polydex.com.
Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry.
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Note: This press release may contain forward-looking statements, within the meaning of the United States Securities Act of 1933, as amended, and the United States Securities Exchange Act of 1934, as amended, regarding Polydex Pharmaceuticals Limited, including, without limitation, statements regarding expectations about future revenues or business opportunities and developments relating to Ushercell or other potential research projects. These statements are typically identified by use of words like "may," "could," "might," "expect," "anticipate" or similar words. Actual events or results may differ materially from the Company's expectations, which are subject to a number of known and unknown risks and uncertainties including but not limited to changing market conditions, future actions by the United States Food and Drug Administration or equivalent foreign regulatory authorities as well as results of pending or future clinical trials. Other risk factors discussed in the Company's filings with the United States Securities and Exchange Commission may also affect the actual results achieved by the Company.