On February 7, 2018 pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today reported financial results for its fiscal 2018 second quarter and six months ended December 31, 2017 and provided an update on its continued operating progress (Press release, pSivida, FEB 7, 2018, View Source [SID1234523802]).
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Recent Operating Highlights
Submitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Durasert three-year treatment for posterior segment uveitis
Obtained from the FDA a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million in connection with the NDA filing
Newly released second Phase 3 study data for Durasert three-year treatment for posterior segment uveitis continued to demonstrate positive efficacy and safety profile at 12 months
Presented Phase 3 data at several medical conferences, including the American Academy of Ophthalmology (AAO) annual meeting and the American Uveitis Society (AUS) winter meeting
Reported positive Phase 1 knee osteoarthritis pain study data indicating that the implant was well tolerated and showed potential for pain reduction through the six-month study period
"We achieved several milestones in the fiscal second quarter and the past few weeks and continue to make material progress in the transformation of pSivida into a fully integrated commercial stage pharmaceutical enterprise," commented Nancy Lurker, President & CEO. "Our highest priority was the NDA submission for Durasert three-year treatment for posterior segment uveitis, which we accomplished in early January. We are also pleased with the continued positive read out of our clinical uveitis data and look forward to presenting these data at upcoming congresses. Meanwhile, we will continue to refine our go-to-market plan in the U.S. and I am confident we have the experienced team and strategy to execute our launch plan with precision."
Fiscal Second Quarter and Six-Month Results
Revenue for the second fiscal quarter ended December 31, 2017 totaled $933,000 compared to $6.0 million for the prior year quarter. The year-ago second quarter included the recognition of deferred collaborative research and development revenue totaling $5.6 million resulting from termination of the Pfizer collaboration agreement. Excluding the Pfizer termination, revenue from feasibility study agreements and royalty income increased to $933,000 for the three months ended December 31, 2017 compared to $387,000 in the prior year quarter. Current period revenues included $196,000 of royalty income received from Alimera Sciences, representing the first quarterly reporting under our July 2017 restructured collaboration agreement. Operating expenses for the three months ended December 31, 2017 increased to $6.7 million from $6.1 million a year earlier, due primarily to professional services costs associated with the NDA filing for Durasert three-year uveitis. Net loss for the quarter ended December 31, 2017 was $5.8 million, or $0.13 per share, compared to net loss of $67,000, or break-even per share, for the prior year quarter.
Revenue for the six months ended December 31, 2017 was $1.3 million compared to $6.2 million for the six months ended December 31, 2016. Excluding the $5.6 million revenue recognized in the prior year period upon termination of the Pfizer agreement, revenues from feasibility study agreements and royalty income increased to $1.3 million for the six months ended December 31, 2017 compared to $664,000 in the prior year six-month period. Operating expenses for the first six months of fiscal 2018 were $13.1 million compared to $13.5 million a year earlier. Higher professional services costs related to the Company’s NDA filing were substantially offset by the absence in the current year-to-date period of severance costs and professional fees related to the Company’s CEO transition and elimination of the position of Vice President, Corporate Affairs and General Counsel in the prior year-to-date period. Net loss for the six months ended December 31, 2017 was $11.8 million, or $0.28 per share, compared to a net loss of $7.2 million, or $0.21 per share for the corresponding fiscal 2017 year-to-date period.
At December 31, 2017, the Company’s cash and cash equivalents totaled $12.9 million.
Anticipated Calendar 2018 Milestones:
FDA acceptance for review of the NDA for Durasert three-year treatment for posterior segment uveitis in calendar Q1
Present 12-month efficacy and safety data from the second Phase 3 clinical study at leading medical conferences
Continue business development efforts and enter into one or more new collaboration agreements with biopharmaceutical companies and other third parties
Expect to complete the GLP safety and pharmacokinetic study for a shorter duration product for posterior segment uveitis
Conference Call
pSivida Corp. will host a live webcast and conference call today, February 7, 2018 at 4:30pm 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 ID is 8399835. A live webcast will be available on the Investor Relations section of the corporate website at View Source
A replay of the call will be available beginning February 7, 2018, at approximately 7:30 p.m. ET and ending on February 14, 2018, at 11:59 p.m. ET. 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: 8399835. A replay of the webcast will also be available on the corporate website during that time.