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Message: Ondine Biopharma Announces Third Quarter 2008 Financial Results

Ondine Biopharma Announces Third Quarter 2008 Financial Results

posted on Nov 14, 2008 04:19AM

Ondine Biopharma Announces Third Quarter 2008 Financial Results
Friday November 14, 7:00 am ET



VANCOUVER, Nov. 14 /CNW/ - Ondine Biopharma Corporation (the "Company" or "Ondine", TSX: OBP; AIM: OBP) a medical technology company developing photodisinfection based products, today announced its financial results for the third quarter ended September 30, 2008.

"During the third quarter we continued to make important progress including discussions with prospective strategic partners as well as towards obtaining regulatory approval to market Periowave(TM) in the United States," stated Carolyn Cross, Ondine's President & CEO, "The FDA confirmed that our Periowave(TM) system will be evaluated under the Premarket Approval (PMA) pathway. Therefore, we have been focused on the tasks required to complete our PMA submission. In light of the challenging capital marketplace, we have initiated an expense control program and are focusing our resources on three key priorities: advancing discussions with potential strategic partners, obtaining FDA approval for Periowave(TM) and further developing our platform photodisinfection technology."



	    2008 Third Quarter Results and Recent Developments

	    FINANCIAL RESULTS

For the quarter ended September 30, 2008 (the "Third Quarter of 2008"), the Company recorded a loss of $3.25 million or $0.05 per common share compared with a loss of $3.18 million or $0.06 per common share during the quarter ended September 30, 2007 (the "Third Quarter of 2007"). For the nine months ended September 30, 2008 (the "First Nine Months of 2008"), the Company recorded a loss of $8.15 million or $0.13 per common share compared with a loss of $10.42 million or $0.19 per common share during the nine months ended September 30, 2007 (the "First Nine Months of 2007"). Product sales of our laser base stations and treatment kits during the Third Quarter of 2008 amounted to $0.15 million with a negative gross margin of $0.27 million after a $0.38 million provision for excess and obsolete inventory compared to product sales of $0.36 million and a gross margin of $0.28 million (77.3%) during the Third Quarter of 2007. Product sales of our laser base stations and treatment kits during the First Nine Months of 2008 amounted to $0.61 million with a gross margin of $0.04 million (7.8%) compared to product sales of $1.48 million and a gross margin of $0.77 million (52.0%) during the First Nine Months of 2007.

REGULATORY AND PRODUCT DEVELOPMENTS

In August of 2008, the Company announced that it had received confirmation from the United States Food & Drug Administration (FDA) that the Company's Periowave(TM) Photodisinfection System will be evaluated as a Class III medical device under premarket approval (PMA) regulations. Receipt of FDA clearance through the PMA pathway would provide competitive barriers that will offer strategic benefits to Ondine in the dental market.

In September of 2008, Company representatives presented a poster entitled "Photodisinfection in the Treatment of Chronic Periodontitis" at the American Academy of Periodontology's (AAP) annual meeting held in Seattle, Washington. This peer-reviewed poster highlighted the positive results of the Company's Canadian Multi-Centre Trial using its Photodisinfection System.

In October of 2008, Dr. Cale Street, the Company's Director of Research, gave a presentation entitled "Photodisinfection: A safe and effective tool for the treatment of adult periodontitis" at the 7th International Symposium on Photodynamic Therapy and Photodiagnosis in Clinical Practice meeting held in Italy. The purpose of the presentation was to provide the scientific and clinical community with an overview of the development of photodisinfection for the treatment of periodontal disease, with an emphasis on the results of the Company's clinical studies utilizing its Periowave(TM) system for this application.

In October of 2008 Company representatives presented data highlighting the efficacy of Ondine's photodisinfection technology for eradicating Staphylococcus aureus and the antibiotic resistant form, MRSA, at the joint American Academy of Microbiology and Infectious Diseases Society of America, a major international conference showcasing innovative research and technologies in the field of infectious diseases, in Washington, DC. The poster was entitled "Repeat Exposure of Bacterial Pathogens to Photodynamic Disinfection does not Induce Resistance Formation".

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