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pSivida Corp. (PSDV)
Q3 2013 Earnings Conference Call
May 13, 2013, 16:30 ET
Lori Freedman - General Counsel and Vice President, Corporate Affairs
Paul Ashton – President and Chief Executive Officer
Len Ross – Vice President, Corporate Affairs, General Counsel and Corporate Secretary
Juan Sanchez - Ladenburg Thalmann Securities
Jason Kolbert - Maxim Group
Previous Statements by PSDV
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I would now like to introduce your host for today's conference, Mr. Lori Freedman, Vice President, Corporate Affairs, General Counsel. Please go ahead.
Thank you, Kate. Good afternoon everyone and thank you for joining us. After the market closed today, we released our third quarter financial results for fiscal 2013. A copy of the release is available in the Investor section of our website at www.psivida.com.
On the call today with me is Dr. Paul Ashton, President and Chief Executive Officer; and Len Ross, our 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 more detailed discussion of the 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 30th, 2012. We undertake no obligation to update any forward-looking statement 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 third quarter of fiscal 2013.
This has been a great quarter for us. Our ILUVIEN product for the treatment of chronic Diabetic Macular Edema insufficiently responsive to existing therapies is now being actively marketed by our partner Alimera Sciences in Germany and for private payors in the U.K.
Reimbursement in the U.K. from the National Health System on the patient access scheme is being considered by NICE and we expect some of the outcome within a few months. Alimera has said, it expects to launch in France in 2013 and is marketing authorizations in three of the European countries and one more Italy in process.
Alimera completed a $40 million financing nine months ago to help fund the European launch and most recently secured a $20 million loan facility. Further, they have reported hiring a Senior Eu-based team with boots on the ground being provided by [print house]. We look forward to seeing the European sales of ILUVIEN ramp up. We are entitled to 20% of the net profits on sales to Alimera on a country-by-country basis.
Other very exciting news for ILUVIEN was the re-filing of the new drug application seeking U.S. approval. The FDA accepted the resubmission for review and gave an October 17, as the PDUFA date and that's the date when the review is expected to be completed.
We are very hopeful that the FDA will agree with the European authorities and conclude that ILUVIEN is safe and effective. If the FDA approves ILUVIEN, we will be entitled to a $25 million milestone payment and 20% of net profit from sales by Alimera in the U.S.
Now more important types on revenues than the revenues we expect to receive from ILUVIEN sales, this product should help us execute on our strategy of transitioning into a specialty pharma company, specifically it should be great help for our posterior uveitis product. As you know, ILUVIEN comprises of small micro-insert releasing the drug fluocinolone acetonide and this is eluded into a single-use inserter, so that it can be injected during an office visit.
This micro-insert is licensed to Alimera for almost all, but not ophthalmic indications. We retain the right to develop the same micro-insert for uveitis. We had a very positive meeting with the FDA and they've reviewed our plans for Phase III clinical trials. We expect our Phase III clinical for this micro-insert for posterior uveitis to begin enrolling patients on schedule by the end of this quarter.
These trials will have a primary endpoint of recurrence of uveitis after 12 months and will involve a total of approximately 300 patients. This is typically a very small number of patients for a Phase III program and part of the reason is that the FDA has confirmed that we can use the data from the DME ILUVIEN studies in support of the uveitis application. This should simplify the development and potential approval process.
We believe that the uveitis program represents a low risk high return opportunity for us. Now, low risk? We know that the micro-insert in ILUVIEN releases fluocinolone acetonide in humans for approximately three years. We know that this drug is highly effective in treating uveitis because it's the same drug that's in our FDA approved Retisert product, which also treats uveitis and we know that while the micro-insert releases a low dose of fluocinolone acetonide than Retisert, in DME at least, it has a very similar efficacy, but with a far better safety profile.