pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced financial results for its second quarter ended December 31, 2013.
"We continued to advance our own pipeline of products. Enrollment continues on schedule for our lead development product, Medidur™ for posterior uveitis, in the first of two planned Phase III trials," said Dr. Paul Ashton, President and CEO of pSivida. "Our lead licensed product, ILUVIEN® for chronic diabetic macular edema (DME), moved closer to potential marketing approval in the U.S. and expanded availability in the EU.
"In posterior uveitis we believe that the trials will show an efficacy profile of Medidur comparable to Retisert®, our FDA-approved implant for posterior uveitis currently being sold by Bausch & Lomb, with a side effect profile superior to Retisert. Preliminary data from a small investigator-sponsored Phase I/II study of Medidur for posterior uveitis patients were consistent with this hypothesis. Medidur, which uses the same micro-insert as ILUVIEN, delivers a lower dosage of the same drug as Retisert," Dr. Ashton continued. Posterior uveitis, an inflammatory disease of one of the layers of the eye, affects approximately 175,000 people in the U.S. Responsible for approximately 30,000 cases of legal blindness, posterior uveitis is the third largest cause of blindness.
"We are very pleased that our licensee Alimera Sciences entered into labeling discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN for DME and plans to respond to the FDA's October 2013 Complete Response Letter (CRL) in the first quarter of 2014. We understand Alimera will be providing recent safety data from patients in the U.K. and Germany and addressing the concerns raised by the FDA regarding the facility at which ILUVIEN for DME is manufactured. Alimera reported that new clinical trials will not be required by the FDA in connection with its review of ILUVIEN for DME prior to approval. If approved, we will be entitled to a $25.0 million milestone payment from Alimera and 20% of net profits on sales of ILUVIEN for DME by Alimera in the U.S.
"We are also encouraged by the speed with which ILUVIEN has been made available to U.K. National Health Service (NHS) facilities. Less than seven weeks after the final guidance from the U.K.'s National Institute for Health and Care Excellence (NICE) recommending ILUVIEN as a treatment option for pseudophakic eyes (those that have had cataract surgery) with chronic DME considered insufficiently responsive to available therapies, initial orders were shipped to NHS hospitals and the first NHS patient was treated. Until receipt of this guidance, ILUVIEN had been available in the U.K. only to private pay and privately insured patients, but will now be available through the NHS to this typically large subgroup of chronic DME patients, subject to a patient access scheme.
"We continue to be encouraged by our studies of potential ophthalmic and non-ophthalmic uses of Tethadur™, our second key technology platform designed to provide sustained delivery of peptides, proteins and antibodies. The importance of these biologics in treatment of ophthalmic disease makes Tethadur a very promising technology," continued Dr. Ashton. The use of Tethadur in certain ophthalmic applications is being evaluated under a funded evaluation agreement with a leading global biopharmaceutical company. Other major pharmaceutical companies are evaluating pSivida's technology platforms in other ophthalmic applications under funded agreements.
Revenues for the quarter ended December 31, 2013 totaled $592,000 compared to $585,000 for the prior year period. Increased collaborative research and development revenue was offset by lower Retisert royalty income from Bausch & Lomb.
Net loss for the quarter ended December 31, 2013 was $3.5 million, or $0.13 per share, compared to a net loss of $2.6 million, or $0.11 per share, for the prior year quarter. The higher net loss in the second quarter of fiscal 2014 primarily reflected costs associated with our Phase III clinical trial of Medidur for posterior uveitis, which commenced in the quarter ended June 2013.
Revenues for the six months ended December 31, 2013 totaled $1.2 million compared to $1.1 million for the six months ended December 31, 2012. The Company reported a net loss of $7.2 million, or $0.27 per share, for the six months ended December 31, 2013, compared to a net loss of $5.2 million, or $0.23 per share, for the same period of the prior year.
At December 31, 2013, cash, cash equivalents and marketable securities totaled $15.7 million compared to $16.5 million at September 30, 2013, reflecting approximately $1.2 million received from an existing collaboration agreement and approximately $1.25 million of net proceeds from sales of common stock under pSivida's at-the-market (ATM) offering program.
Today's Conference Call Reminder
pSivida Corp. will host a live webcast and conference call today, February 7, 2014, at 4:30 pm ET. The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference can also be accessed on the pSivida Corp. website at www.psivida.com. A replay of the call will be available approximately two hours following the end of the call through February 14, 2014. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID number 52647338.