Published:
Polydex Pharmaceuticals Reports Second Quarter Results
Polydex Pharmaceuticals Limited (NASDAQ: POLXF)
reports financial results for its second fiscal quarter, the three-month
period ending July 31, 2005.
POLYDEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
SECOND QUARTER RESULTS, FISCAL 2006
QUARTER ENDED: July 31, 2005
(Unaudited figures, stated in U.S. dollars)
Quarter ended 7/31/2005 Quarter ended 7/31/2004
Sales $ 1,273,470 $ 1,338,409
Net Income (loss) (228,432) 12,759
Earnings (loss) per
common share - basic (0.07) 0.00
Earnings (loss) per
common share - diluted (0.07) 0.00
Wtd. avg. common
shares outstanding 3,052,296 3,037,463
A number of factors have affected the net income of the Company this
quarter. Fluctuating currency exchange rates continue to have an affect on
margins and profitability, and more recently, rising energy costs and
subsequent effect on the price of raw materials has contributed to the
decline in net income. Management has been examining ways to increase
production and decrease costs of operation to meet the challenges of the
changing operating environment.
George Usher, President and CEO, says, "We have opportunities for growth
with our current customer base, as well as forging into new markets, and
are working to increase overall quality and production to meet sales
objectives."
Planning for anticipated growth in demand for the Company's core product
line, we are investing part of the capital gained from the sale of the
Kansas facility to implement a series of refurbishments to the Toronto
facility, and acquiring new equipment. Conversion of some internal
procedures for compliance with GMP standards has been completed. A Good
Manufacturing Practices certification will be required to meet production
goals by 2006. To accomplish the necessary upgrades, we can expect that
increased capital expenditures will continue through fiscal year end of
January 2006.
Management also continues to seek strategic bio-pharmaceutical alliances
for the future commercial development of Ushercell, while maintaining
production with outsourced GMP facilities that have successfully produced
and shipped hundred of thousands of individual dose units of Ushercell to
clinical trial sites in the U.S., Brazil, India and Africa. This has
contributed to keeping the cost of production of Ushercell to a minimum,
while maintaining consistent production of units for the various clinical
trial sites.
In this past quarter, Ushercell became the recipient of $24 million in
additional funding to CONRAD from the
United States Agency for International Development (USAID) and the Bill and
Melinda Gates Foundation. This grant funding enabled CONRAD to commence the
second of two Phase III clinical trials to determine Ushercell's
effectiveness for the prevention of HIV and other sexually transmitted
diseases. CONRAD, in collaboration with Family Health International, has
also recently completed a Phase II clinical trial assessing the efficacy of
Ushercell as a contraceptive, for which a report is expected in mid-2006.
CONRAD is a cooperating agency of USAID committed to improving reproductive
health by expanding the contraceptive choices of women and men and by
helping to prevent the transmission of HIV/AIDS and other sexually
transmitted diseases. CONRAD is administered through the Department of
Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in
Norfolk, VA, with the main office located in Arlington, VA.
Ushercell is among the leading candidates in the development of an HIV
prevention microbicide, and as such has been featured in a number of
television news stories across Canada and the US, as well as a variety of
international print articles from India, Africa, the UK and in Canada's
national newspaper, The Globe and Mail, featuring a story written by
award-winning journalist, Stephanie Nolen (Globe, May 24, 2005, AIDS: A
devastating setback in Africa but a drug from Canada offers hope)
George Usher says, "We're obviously very pleased with the development
achievements of Ushercell, and as this important research continues to gain
broader exposure and international support, I'm looking forward to
attending presentations and scientific findings at the Microbicides 2006
conference," a biennial event to be next held in Cape Town, South Africa in
April 2006.
Also during this quarter, preparations for a clinical trial to evaluate
Ushercell's effectiveness at treating a common disorder among
reproductive-age women, Bacterial Vaginosis (BV) remained in progress. As
Bacterial Vaginosis may act as a co-factor in the heterosexual transmission
of HIV, the impact of vaginal microbicides on Bacterial Vaginosis warrants
further study.
With the contraceptive trial now completed, and the BV trial preparing to
commence, Management anticipates that either of these indications could
present an opportunity to bring Ushercell to market ahead of results from
the HIV prevention trials which are anticipated to last several years.
Currently, the global contraception market alone is valued at US$4.4
billion per year.
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.
Please visit the Company's website: www.Polydex.com.
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. 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.
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Tags: ,Pharmaceuticals and Biotech:Drugs, ,NASDAQ01,NASDAQ01,,TORONTO
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