pSivida Corp. (NASDAQ:PSDV), a leader in the development of sustained release, drug delivery products for treating eye diseases, announced financial results for its third quarter ended March 31, 2015.
Our licensee Alimera Sciences launched ILUVIEN® in the U.S. for diabetic macular edema (DME) in the quarter. ILUVIEN is now widely available to the estimated 575,000 patients with clinically significant DME in the country. In the U.S. ILLUVIEN is indicated for the treatment of DME in patients previously treated with a course of corticosteroids without a clinically significant rise in intraocular pressure.
ILUVIEN was also launched in Portugal in the quarter, making it the third EU market. ILUVIEN has been sold in theU.K. and Germany since 2013. Three more EU countries granted approvals in the quarter, completing the last applications and bringing the number of EU country approvals to 17. ILUVIEN is indicated in the EU for treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. ILUVIEN has been sublicensed in Australia and New Zealand by Alimera.
“We are very pleased ILUVIEN has been launched in the U.S. The efficacy and three-year treatment duration of ILUVIEN should make it a very attractive treatment alternative for patients with clinically significant DME in comparison to anti-VEGF therapy, which requires frequent injections and may not optimally manage the disease,” said Paul Ashton, Ph.D., President and CEO of pSivida. “Our licensee, Alimera Sciences, is making a significant investment in the U.S. launch, which we are optimistic will ultimately benefit us through our net profit participation from U.S. sales.” pSivida is entitled to 20% of the net profits from sales of ILUVIEN by its licensee on a country-by-country, quarter-by-quarter basis and 20% of royalties and 33% of other amounts from sublicenses of ILUVIEN.
Clear FDA Regulatory Path for Medidur™ for Posterior Uveitis. Medidur™ for posterior uveitis, pSivida’s lead development product, which uses the same injectable, sustained-release micro-insert as ILUVIEN (same design, same drug, same polymer, same release rate), also provides three years of treatment from a single injection. Posterior uveitis is the third leading cause of blindness in developed countries.
In recent meetings, pSivida reached agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for Medidur that allows for a new drug application (NDA) to be filed in the first half of 2017. The FDAagreed, pending clinical trial results, that it would accept an NDA based on data from the ongoing Medidur Phase III trial (which has a primary endpoint at 12 months), data from a second Phase III trial with a shorter, 6-month primary endpoint and data referenced from the already completed Phase III ILUVIEN trials. pSivida will also submit data from a small utilization study of its newly designed inserter that uses a standard 27 gauge needle.
“We are very pleased that we have a clear regulatory path that should permit us to file the NDA for Medidur with only a short delay from the timing we anticipated based on a single Phase III trial. We had budgeted for the second trial pending FDA guidance, so the second trial does not change our liquidity projections,” said Dr. Ashton. This quarter we completed enrollment in the first Phase III trial with the longer 12-month primary endpoint, and we expect top-line data in the second quarter of 2016. We have already initiated the second Phase III trial, which will enroll up to 150 patients in India.
“Our $31.7 million in cash at the end of the quarter should give us the capital resources to continue our planned product development programs, including both Medidur trials, into 2017, even without any potential future net profits contribution from ILUVIEN,” said Dr. Ashton.
The Company continued its pre-clinical development program focused on developing pharmaceutical products to treat chronic diseases of the retina using pSivida’s platform technologies.
“We are working to develop micro-inserts delivering already approved drugs for the treatment of wet and dry age-related macular degeneration (AMD) and glaucoma. We are particularly excited about the potential opportunity for dry AMD treatment as there is currently no approved treatment for this devastating disease. Dry AMD accounts for 85 to 90% of all cases of AMD, which currently affects several million Americans alone. Dry AMD has an estimated prevalence of 3 – 4% in the U.S., and that is projected to increase as the population ages. In osteoarthritis we are making good progress in our collaboration with Hospital for Special Surgery to take a sustained release implant into clinical trials. Our work with Tethadur, our sustained release system for peptides, proteins and anti-bodies, is continuing to progress toward clinical trials.”
Results for the FY2015 Third Quarter. Revenues for the quarter ended March 31, 2015 totaled $328,000compared to $2.0 million for the prior year’s third quarter. The decrease was primarily due to recognition of $1.5 million in the prior year quarter under a completed feasibility study agreement and lower Retisert royalties.
Operating expenses for the three months ended March 31, 2015 totaled $5.4 million compared to $4.2 million a year earlier. The increase was primarily attributable to CRO costs for the Medidur clinical development program and higher stock-based compensation.
Net loss for the quarter ended March 31, 2015 was $5.0 million, or $0.17 per share, compared to a net loss of $2.2 million, or $0.08 per share, for the prior year quarter.
Revenues for the nine months ended March 31, 2015 totaled $26.2 million compared to $3.2 million for the nine months ended March 31, 2014. The increase reflected the $25.0 million milestone for FDA approval of ILUVIEN recorded in the fiscal 2015 first quarter, partially offset by a $1.8 million reduction in revenues from funded technology evaluation agreements.
Operating expenses for the nine months ended March 31, 2015 totaled $14.5 million compared to $12.7 million for the same period of the prior year, with the increase primarily due to costs of the Medidur clinical development program and higher stock-based compensation.
Net income for the nine months ended March 31, 2015 totaled $11.5 million, or $0.38 per diluted share, compared to a net loss of $9.4 million, or $0.35 per share, for the nine months ended March 31, 2014.
At March 31, 2015, cash, cash equivalents and marketable securities totaled $31.7 million. The Company’s quarterly cash burn is expected to vary from quarter to quarter based on the timing and amounts of cash payments, including CRO payments, and cash receipts under collaboration agreements. (Original Source)
Shares of pSivida Corp closed yesterday at $4.4 . PSDV has a 1-year high of $4.94 and a 1-year low of $3.40. The stock’s 50-day moving average is $4.10 and its 200-day moving average is $4.11.
On the ratings front, MLV & Co. analyst Arlinda Lee maintained a Buy rating on PSDV, with a price target of $6.50, in a report issued on March 26. The current price target represents a potential upside of 47.7% from where the stock is currently trading.
According to TipRanks.com, Lee has a total average return of -2.8%, a 39.2% success rate, and is ranked #3131 out of 3596 analysts.
pSivida Corp develops tiny, sustained-release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years.