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December
15, 2005
Polydex Pharmaceuticals
Reports Third Quarter Results and
Formation of Strategic and Scientific Advisory Board
Toronto, Ontario, December 15, 2005 -- Polydex Pharmaceuticals Limited ( NASDAQ: POLXF ) reports financial results for its third fiscal quarter, the three-month period ending October 31, 2005.
POLYDEX PHARMACEUTICALS LIMITED AND SUBSIDIARIES
THIRD QUARTER RESULTS, FISCAL 2006
QUARTER ENDED: October 31, 2005
(Unaudited figures, stated in U.S. dollars)
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Sales |
$
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1,062,075
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$
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1,205,859
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Net
income
(loss)
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(261,451)
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(240,522) |
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Earnings
(loss)
per common share - basic |
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(.09)
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(.08) |
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Earnings
(loss)
per common share - diluted |
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(.09)
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(.08) |
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Wtd.
avg. common shares outstanding |
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3,052,296
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3,042,296
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The Company maintains significant cash and investments and little debt.
The sales were lower in this third quarter primarily due to a plant shutdown for necessary repairs on boiler equipment. As part of the overall plan for refurbishment of the plant, the upgrade of the facilities and certain equipment is now underway. A new spray dryer has been purchased during this quarter, and the company truck was also replaced. These equipment additions resulted in expenditures of $182,408 this quarter ($270,000 year to date).
As has been previously reported, Good Manufacturing Practice certification is being sought to increase the markets where product can be sold. To accomplish the necessary upgrades, Management expects that increased capital expenditures will continue through fiscal year end of January 2006 and into fiscal 2007.
The overall margins decreased from 8% to 7%, predominantly due to the pressure of the declining US dollar, and the continued upward pressure on the costs of raw material and shipping.
Management sought to have more expert focus on the development and commercialization of Ushercell, the company's leading human pharmaceutical compound, currently engaged in Phase III clinical trials to determine efficacy at prevention of HIV and other sexually transmitted diseases. To that end, a Strategic and Scientific Advisory Board has been formed to provide Management and the Polydex Board of Directors with expert advice, counsel and direction to optimize and capture the commercial value of Ushercell for Polydex.
George Usher, President and CEO is pleased to announce the formation of this Strategic and Scientific Advisory Board to include the expertise of Richard A. Olson, MBA, David McConoughey, George Collins, Ph.D., Michael Jaffe, Ph.D., Frank Greaves, and David Cymerman and said “ These individuals are not only leaders in key technical areas ranging from drug discovery to manufacturing, but they also all bring industry experience to the Board, which will be instrumental as we move toward commercializing Ushercell and future technologies”.
Mr. Olson brings extensive business and marketing expertise to this board; Mr. McConoughey is an intellectual property attorney and business strategist; Dr. Collins has significant experience in the polymer field; Dr. Jaffe is a Professor of Biomedical Engineering at NJIT and is a polymer and biomaterials expert; Mr. Greaves' expertise is in scale up from pilot and clinical manufacturing to meet NDA, projected commercial, and all regulatory and GMP requirements; and Mr. Cymerman brings extensive expertise in quality control, GMP and regulatory controls.
Management 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 hundreds 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 down the cost of production of Ushercell, while maintaining consistent production of units for the various clinical trial sites.
The Company has incurred an increase of $34,096 in research and development expenditures over the third quarter in the previous year, relating to preparations for a clinical trial to evaluate Ushercell's effectiveness at treating a common disorder among reproductive-age women, Bacterial Vaginosis (BV). 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.
The development of Ushercell for contraceptive and HIV prevention properties has been supported principally by CONRAD, 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.
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.
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.
Contact for CONRAD: Annette Larkin, 202-429-4929, AnnetteLarkin@rationalpr.com
Investor
Relations for Polydex Pharmaceuticals Limited
North Arm Capital Services
Linda Hughes, Toll-free 1-877-945-1621
or e-mail: Linda@northarm.com
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