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pSivida Corp. (PSDV)
F4Q2012 Earnings Conference Call
September 24, 2012, 16:30 p.m. ET
Lori Freedman - VP, Corporate Affairs, General Counsel, and Corporate Secretary
Paul Ashton - President and CEO
Len Ross - VP, Finance and Principal Financial and Accounting Officer
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It's now my pleasure to turn the floor over to Lori Freedman. Please go ahead.
Thank you, Huey. Good afternoon everyone and thank you for joining us. After the market closed we released our fourth quarter and full-year financial results for fiscal 2012. A copy of the release is available in 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, 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 maybe 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 he results and other expectations express 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 conditions, I refer you to our filings with the SEC including our quarterly report on Form 10-Q for the quarter ended March 31, 2012. 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.
Great. Thank you, Lori. Welcome everyone as we discussed the results of the fourth quarter of fiscal 2012. This was another excellent quarter for us. Here are some of the headlines. First, the FDA cleared IND for the product for independently developing for the treatments of uveitis affecting the posterior uveitis segment permitting us to move directly into Phase III clinical trial.
Second, Alimera Sciences have continued to make progress on the commercialization of the ILUVIEN for DME in the EU. Marketing and authorizations have not been received in five EU countries and the commercial launch is planned for Germany, France and the UK in 2013. Alimera has also reported in France to resubmit the NDA in the U.S.
Third, we have made good progress on Tethadur, our peptide protein delivery system. We announced the execution of a funded technology evaluation agreement with the large biopharmaceutical company our first for this technology.
Number four is of course cash. We ended the quarter with over $14 million in cash and subsequently raised some additional 4.7 million in a registered direct offering.
Okay. So let’s get into some of the details. The uveitis affecting the posterior uveitis segment that’s the back-of-the-eye is a nasty disease. It affects just under 200,000 people in the U.S. but is one of the leading closes of vision loss, about third or four in the U.S. It's estimated as there are about 30,000 cases of blindness in the U.S. due to posterior uveitis. Uveitis is an inflammatory autoimmune disease that can have many triggers one can develop in the felicitation with diseases like lupus or MX or a variety of other conditions. Sometime they can be a genetic component such as the case in Behcet’s disease. And in many cases it's idiopathic. Thirdly, the disease in normally treated with off-label use of systemic drugs.
So, two FDA approved products of treatment disease, Retisert, Bausch & Lomb under license from us and OZURDEX sold by Allergan. Unfortunately for various reason neither of these products have succeeded in significantly changing the management of the disease for most patients. Uveitis continues to be managed largely by systemic steroids, and when the side effects of this treatment becomes too problematic by modulating drugs such as methotrexate, cyclophosphamide or Humera. These of course have their own systemic problems.
Our injectable micro-insert for posterior uveitis is the same ILUVIEN approved in several European countries for DME. So, why are we confident about the use of this product in uveitis, while micro-insert delivers fluocinolone acetonide, which is the same drug delivered by the Retisert device, which is FDA approved for uveitis. Retisert is extremely effective for a) must be surgically inserted and b) it has some significant side effects including increased intra-ocular pressure or IOP. In clinical trials, over 60% of patients develop an IOP above 30 millimeters of mercury at [some point] another 30% of patients needed a second operation to control this IOP. This is where we believe the ILUVIEN type micro-insert will be attractive to uveitis.
It's injected during an office visit so no need for surgery and so far, half of your IOP related side effects. In the DME Phase III studies conducted by Alimera, fewer than 20% of patients develop an IOP of over 30 millimeters compared with 60% for Retisert and most of these manage with eye drops only 5% requiring a surgery to lower pressure compared to a 30% for Retisert.