the revenues are improving
InSite Vision Reports Third Quarter 2010 Financial Results
-- AzaSite® Royalty Revenues Up 16 Percent Over Second Quarter 2010 --
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Companies:Insite Vision Inc.
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Press Release Source: InSite Vision Incorporated On Thursday November 4, 2010, 4:01 pm EDT
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB:INSV.ob - News) today reported operating and financial results for the quarter ended September 30, 2010. Total revenue for the third quarter of 2010 was $3.2 million with an operating income of $0.2 million and a net loss of $2.3 million. As of September 30, 2010, cash, cash equivalents and marketable securities totaled $17.6 million.
Corporate and Commercial Updates
In August 2010, InSite Vision commenced a Phase 1/2 clinical trial of ISV-303 for the treatment of pain and swelling associated with ocular surgery. ISV-303 is a topical anti-inflammatory and pain product candidate that combines a low concentration of bromfenac with InSite Vision’s proprietary DuraSite® technology to extend and improve the topical delivery of medication to the eye.
InSite Vision is working with the U.S. Food and Drug Administration (FDA) to obtain a Special Protocol Assessment (SPA) for the Phase 3 development program of ISV-502 and ISV-305 for the treatment of blepharitis, an ocular disease characterized by inflammation of the eyelids. ISV-502 and ISV-305 each leverage InSite’s proprietary DuraSite technology. ISV-502 combines azithromycin and dexamethasone in DuraSite, and ISV-305 incorporates dexamethasone in DuraSite.
Prescriptions of AzaSite® (azithromycin ophthalmic solution) 1%, for the treatment of bacterial conjunctivitis, increased by 15 percent in the third quarter of 2010 from the second quarter of 2010 and by 45 percent compared to the third quarter of 2009. AzaSite is marketed by Inspire Pharmaceuticals in the United States.
In October 2010, InSite was informed that it will receive a Therapeutic Discovery Project Grant of $489,000 from the U.S Government for the clinical development of ISV-502 and ISV-303.
InSite Vision will be presenting a corporate update at the upcoming Wall Street Analyst Forum financial conference on November 11th, 2010 in New York City.
“We are making excellent progress in 2010 in advancing our therapeutic pipeline of DuraSite-enabled products. During the quarter we announced commencement of a Phase 1/2 clinical trial of ISV-303. We also are making good progress for an SPA with the FDA for our planned Phase 3 clinical study of ISV-502 and ISV-305,” said Louis Drapeau, InSite Vision’s Chief Executive Officer.
Third Quarter 2010 Results Summary
Revenues in the third quarter of 2010 were $3.2 million compared to $2.2 million for the third quarter of 2009. Third quarter 2010 revenues included royalties from Inspire Pharmaceuticals of $2.8 million for sales of AzaSite compared to $2.2 million in the third quarter of 2009. Of note, for the first time royalties received from product sales of AzaSite in the third quarter of 2010 exceeded the combined required loan interest and Pfizer royalty payments. InSite Vision also received royalties from global net product sales of Besivance® (besifloxacin ophthalmic suspension) 0.6% by Bausch & Lomb. Both AzaSite and Besivance utilize InSite Vision’s proprietary DuraSite drug delivery technology.
Research and development (R&D) expenses for the third quarter 2010 were $1.4 million compared to $1.0 million in the third quarter 2009. The increase in R&D expenses was primarily driven by the initiation of the ISV-303 Phase 1/2 clinical trial in the third quarter of 2010.
General and administrative (G&A) expenses were $1.0 million for the quarter ended September 30, 2010 compared to $1.4 million in the same quarter in 2009. G&A expenses in 2010 were lower due to lower personnel expenses in 2010 due to the company’s 2009 corporate restructuring.
Net loss for the quarter ended September 30, 2010 was $2.3 million, or $0.02 per share, compared to a net loss of $3.1 million, or $0.03 per share, in the same quarter of 2009.
InSite Vision had cash, cash equivalents and short-term investments of $17.6 million at September 30, 2010. Total cash usage in the third quarter 2010 was $2.6 million.
