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pSivida Corporation (PSDV)
F2Q 2013 Earnings Call
February 6, 2013 4:30 PM ET
Paul Ashton – President and CEO
Len Ross – VP, Corporate Affairs, General Counsel and Corporate Secretary
Previous Statements by PSDV
» pSivida's CEO Discusses F1Q13 Results - Earnings Call Transcript
» pSivida's CEO Discusses F4Q2012 Results - Earnings Call Transcript
» Psivida Ltd. F2Q10 (Qtr End 12/31/09) Earnings Call Transcript
As a reminder, today’s conference is being recorded for replay purposes. I would now like to turn the conference over to your host for today, Mr. Lori Freedman, General Counsel and VP of Corporate Affairs. Ma’am, you may begin.
Thank you, Mary [ph]. Good afternoon everyone and thank you for joining us. After the market close today, we released our second 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 an answer 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 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 statement. For more detailed discussion of the risk factors that could impact our future results and financial condition, I’ll refer you to our filings for the SEC including our annual report on Form 10-K for the fiscal year end to June 30th of 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.
Thank you, Lori, and welcome everyone as we discussed the results of our second quarter of fiscal 2013.
I’d like to start with focusing you on our strategy. As previously discussed, we began our transition from the licensed-based truck delivery company relying exclusively on partnerships to developing commercialize products to a specialty pharma model.
We define to you some of the revenues generated and lessons learned from our partnerships to develop some of our own products ourselves. Of course, I will still look into collaboration as we where it’s appropriate. For example, in the development of new chemical entities, all of our products recline in context of expensive clinical trials.
But increasingly, we look to develop our own products. Now, moving from the strategy and tactics, our lead development product, which we plan to move forward ourselves in that partner, is our micro-insert to threat posterior uveitis.
We expect it will begin Phase III clinical trial for next quarter on [inaudible]. We continue to engage in pre-clinical studies of Tethadur, our technology system to deliver proteins and antibodies and we’re encouraged by the result so far.
Finally, Alimera scientist, our partner on the ILUVIEN for diabetic macular edema is our plan which direct commercial launch in Germany by the end of this quarter. So looking for DME, we’ve now received marketing authorization in Germany, France, Austria, Spain, Portugal and the U.K.
With respect to U.S. approval, Alimera has reported that they intend to resubmit the NDA later this quarter. It was approval we’ve taken $25 million amount of payment and profit share.
Finally, with respect to our capital resources, we ended the quarter with over $15.7 million in cash and cash equivalent which we believe should enable us to maintain our current and planned operations into the first quarter of calendar year 2014 including our phase three clinical trial for posterior uveitis and for this fiscal year.
Those are the headlines. I’ll get into more details now before handing the call over to Len Ross who will take you through the financial results.
First, let’s talk about uveitis. Uveitis affecting the back of the eye of posterior segments, is an awful disease affecting just under 200,000 people in the U.S. But it’s a serious one and it’s difficult to treat.
It’s a third or fourth leading cause of blindness in the U.S. with an estimated 30,000 cases of blindness. Uveitis is defined as inflammation of the uveal tract, which is one of the inner linings of the eye. And like many autoimmune diseases and as many different figures, it can occur spontaneously, and in some cases it’s idiopathic, the main current therapy also able to use systemic therapy.
While it works well for some patients, generally, in order to get enough drugs to the eye, there’s a significant exposure of the antibody to the drug systemic steroids can be significant and sometimes intolerable and vulnerable set of side effects.
And this can require patients to switch from steroids to immune-modulating drugs that can themselves have their own significant side effects. And finally, of course, the daily doses required significant issues of patient compliance.