Feb 12 2010
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA) (FF: PV3), a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back-of-the-eye diseases, today announced financial results for its second quarter and six months ended December 31, 2009.
“Commencing April 2010, the annual interest rate on our $15 million conditional note from Alimera increases to 20% and monthly principal payments of $500,000 are scheduled to begin”
The Company reported a consolidated net loss of $24,000, or $0.00 per share for the quarter ended December 31, 2009, compared to a consolidated net loss of $870,000, or $0.05 per share, for the quarter ended December 31, 2008.
Revenues totaled $3.4 million for the three months ended December 31, 2009 compared to revenues of $2.9 million for the three months ended December 31, 2008. Cash and cash equivalents totaled approximately $5.1 million at December 31, 2009, a decrease of $834,000 compared to approximately $6.0 million at September 30, 2009. Approximately $1.3 million of cash used in operations during the three months ended December 31, 2009 was partially offset by $484,000 of proceeds from the exercise of investor warrants.
For the six months ended December 31, 2009, the Company reported a consolidated net loss of $1.6 million, or $0.09 per share, compared to a consolidated net loss of $1.3 million, or $0.07 per share, for the six months ended December 31, 2008. Revenues for the six months ended December 31, 2009 were $6.8 million compared to revenues of $5.8 million for the six months ended December 31, 2008.
Revenues for the three and six month periods ended December 31, 2009 and 2008 were predominantly related to the Company’s collaboration agreement with Alimera Sciences, Inc. (Alimera).
“We are very encouraged by the recently released top-line 24 month safety and efficacy data from the ongoing Phase III Iluvien® trials for the treatment of diabetic macular edema (DME),” said Dr. Paul Ashton, President and CEO of pSivida.
The Phase III trials are being conducted and funded by the Company’s collaborative partner Alimera. On the basis of these data, Alimera has announced plans to file an NDA with the FDA in the second calendar quarter of 2010 and to request Priority Review. If approved, this would be the first ophthalmic drug therapy for DME, a potentially blinding eye disease that affects more than one million people in the United States alone. Receiving Priority Review status could result in a decision from the FDA by as early as the end of 2010 and, if positive, Alimera anticipates first sales of Iluvien could be as early as the first calendar quarter of 2011. Alimera is also conducting investigator-sponsored studies designed to assess the safety and efficacy of Iluvien in wet and dry age-related macular degeneration and retinal vein occlusion.
“Commencing April 2010, the annual interest rate on our $15 million conditional note from Alimera increases to 20% and monthly principal payments of $500,000 are scheduled to begin,” said Dr Ashton. “The occurrence of certain Alimera liquidity events, such as an acquisition or IPO generating over $75m in gross proceeds, would accelerate payment of the note. In addition, FDA approval of Iluvien would trigger a $25 million milestone from Alimera and, once commercialized, pSivida would be entitled to receive 20% of any Iluvien profits,” explained Dr. Ashton.
“Beyond the Iluvien trials, we are advancing the development of non-Iluvien product candidates through our ongoing collaboration agreement with Pfizer, Inc. and through the application our BioSilicon technology. We are excited by the opportunities in our product pipeline,” concluded Dr. Ashton.
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