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pSivida Corp. (PSDV)
F1Q13 Earnings Call
November 8, 2012 4:30 pm ET
Lori Freedman – Vice President, Corporate Affairs, General Counsel and Secretary
Paul Ashton – President and Chief Executive Officer
Leonard S. Ross – Vice President-Finance, Principal Financial Officer
Juan F. Sanchez – Ladenburg Thalmann Securities
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I would now like to introduce your host of this conference call, Ms. Lori Freedman. you may begin ma’am.
Thank you, Kevin. Good afternoon everyone and thank you for joining us. After the market-close today, we released our first quarter financial results for fiscal 2013. A copy of the release is available on the Investors section of our website at www.psivida.com. On the call with me today are 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 fact 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 the risk factors that could impact our future results and financial conditions, I’ll refer you to our filings with the SEC including our Annual Report on Form 10-K for the fiscal year ended June 30, 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, and welcome everyone as we discuss the results of our first quarter of fiscal 2013. This was another good quarter for us. Here are some of the headlines and I’ll go into some detail on each of these in a moment. First, we’re making good progress in the planning of the two pivotal Phase III clinical trials for posterior uveitis micro-insert. As you will recall, the FDA only accreted to proceed directly into these trials.
Next, we’re continuing to make strides in the development of our Tethadur platform technology for the delivery of peptides and proteins. Third Alimera Sciences, plans for the direct commercial launch of ILUVIEN in the EU next year and expected resubmission of the NDA in the U.S. in the first quarter of 2013.
And finally, with respect to our capital resources, we ended the quarter with over $17.6 million in cash and cash equivalents, following a registered direct offering in August 2013.
Now I’ll go into some details, the uveitis affecting the back of the eye or posterior segments is considered to be the third or fourth largest cause of blindness in the U.S. with an estimated 30,000 cases of blindness despite affecting less than 200,000 people in the U.S.
So it’s an open indication of that nasty one. The uveitis is an inflammatory condition that can have many triggers or it can occur spontaneously, but in many cases, it’s idiopathic. The disease is currently generally treated with off-label use of systemic drugs. But there are also two FDA approved products to treat the disease, our product Retisert, licensed and sold by Bausch & Lomb and OZURDEX sold by Allergan.
Unfortunately, neither of these products succeeded in significantly changing the malignance of the disease from those patients. As a result, uveitis patients continue to suffer the side effects of systemic steroids, while the side effect of the treatment become too problematic, we often achieved immune modulating drugs such as methyl phosphate, cyclophosphamide and Alimera, which of course have their own systemic problems.
So why do we think our micro-insert could succeed over systemic steroids. First, we believe there is a need for targeted delivery. Our micro-insert delivered fluocinolone acetonide, which is an off-patent steroid. So it provides direct steroid delivery to the eye rather than dosing the entire patients thereby staying the patients’ systemic side effects.
Retisert delivered the same drug with fluocinolone acetonide as our micro-insert and it’s extremely effective in treating uveitis, both have two main issues. It requires a surgical perceivably inserted and further, they have some significant side effects including increased intraocular pressure. In Phase III clinical trials, over 60% of patients developed increased eye pressure, and that’s a pressure above 30 millimeter. At some point during the trial, another 30% of patients needed a second operation to control this pressure.
By contrast, our micro-insert, which delivers fluocinolone acetonide on a steady basis up to 36 months, it injected intraocular uveitis. So there is one significant advantage of the surgically implanted Retisert. with respect to ocular pressure related side effects, our micro-insert is the same one Alimera is marketing, if you’re losing for diabetic macular edema.
So we already know quite a lot about how this micro-insert behaved in the eye. The ILUVIEN and DME studies conducted by Alimera should far fewer elevations of eye pressure less than 20% compared with approximately 60% to Retisert and far fewer pressure lowering surgeries less than 5% compared with our 30% for Retisert.