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pSivida Corp (PSDV)
F2Q 2014 Earnings Call
February 7, 2014 4:30 PM ET
Lori Freedman - IR
Paul Ashton - President and CEO
Leonard Ross - VP, Finance and Principal Financial Officer
Suraj Kalia - Northland Securities
Juan Sanchez - Ladenburg
Anup Dalal - KVP
Previous Statements by PSDV
» Q2 2014 P Sivida Corp Earnings Conference call (Webcast)
» pSivida's CEO Discusses F1Q 2014 Results - Earnings Call Transcript
» pSivida Corp. Discusses Q1 2013 Results (Webcast)
I would now like to turn the conference to our host, Ms. Lori Freedman. Ma'am you may begin.
Thank you, Eric. Good afternoon everyone and thank you for joining us. After the market closed today, we released our second quarter financial results for fiscal 2014. A copy of the release is available on the Investor section of our website at www.psivida.com. On the call with me today is Dr. Paul Ashton, President and Chief Executive Officer; and Len Ross, Vice President, Finance.
Before I hand the call over to Paul, I need to remind everyone that some of our prepared remarks are and answers to your questions may be forward-looking in nature. Forward-looking statements are inherently subject to risks and uncertainties. All statements other than statements of historical facts are forward-looking statements, and we cannot guarantee that the results and other expectations expressed, anticipated, or implied will be realized. Actual results could differ materially from those anticipated, estimated or projected in the forward-looking statements. For a more detailed discussion of risk factors that could impact our future results and financial condition, I refer you to our filings with the SEC including our Annual Report on Form 10-K for the fiscal year ended June 30, 2013. We undertake no obligation to update any forward-looking statements in order to reflect events or circumstances that may arise after this conference call.
With that, I’d like to turn the call over to Paul.
All right. Thank you, Lori. And welcome everyone as we discuss the results of our second quarter of fiscal 2014. This was another very good quarter for us, with good progress on Medidur, ILUVIEN for DME and Tethadur. Progress on our lead development product Medidur continues on track. This product is an injectable sustained release micro-insert for the treatment of posterior uveitis, A serious disease of the back-of-the-eye, which is about the third or fourth largest cause of blindness in the U.S.
Enrollment for the first of our two planned pivotal Phase III trials for Medidur is expected to be completed by the end of the summer. Based on the clinical trial results for Retisert, the FDA approved product for the treatment of posterior uveitis that we developed and licensed to Bausch & Lomb and on the results of ILUVIEN for DME we expect our trials for Medidur will show that it is as effective as Retisert, but with a better safety profile. We're developing Medidur independently.
Turning to our lead licensed product, ILUVIEN for DME, we received very, very promising news in both the U.S. and the UK. ILUVIEN is an injectable sustained release implant for the treatments of Diabetic Macular Edema that we developed and licensed to Alimera Sciences. In December, Alimera reported that it had entered into labeling discussions with the FDA, with respect to ILUVIEN for DME but the FDA had scheduled a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee to provide assistance in the deficiencies identified in the FDA's October complete response letter and advice with respect to patient population in which the benefits of the drug product might avoid the risk.
As a result of the labeling discussions, that meeting was deemed unnecessary and has been canceled and Alimera plans to file a response to the CRL by the end of this quarter. This response will be based on data from the already completed clinical trials as well as recent safety data from patients in the United Kingdom and Germany.
Alimera reported that the FDA has indicated that new clinical trials will not be required in connection with its review of ILUVIEN for DME prior to approval. So we look forward to further progress on this application. A FDA approval would trigger a $25 million milestone payments to us from Alimera, who would also be entitled to a share of net profits on sales of ILUVIEN in the U.S.
In Europe where ILUVIEN has been marketed in the UK and Germany since mid-2013 and is scheduled to be launched in France this year, we look forward to continued growth in sales. In the UK this should be greatly helped by the recent recommendation by this UK's National Institute for Health and Care Excellence, NICE -- that with recommendation by them of ILUVIEN as a treatment option for the typically large subset of chronic DME patients who've previously undergone cataract surgery. With this recommendation treatments of these patients with ILUVIEN will not be covered by the UK's National Health Service.
Previously, ILUVIEN was available in the UK only to private pay and privately insured patients. We're very pleased with the rapid implementation of their recommendation from NICE. Indeed Alimera has already shipped product to UK National Health Service hospitals beginning in early January. Our ILUVIEN agreement has provided us with considerable cash thus far and we're optimistic that further revenues from this agreement will continue to help fund our growth.