PSDV

pSivida Corp. (PSDV)

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Psivida Ltd. (PSDV)

F2Q10 (Qtr End 12/31/09) Earnings Call

February 10, 2010 04:30 am ET

Executives

Lori Freedman - VP, Corporate Affairs, General Counsel and Corporate Secretary

Paul Ashton - President & CEO

Len Ross - VP of Finance & Principal Accounting Officer

Analysts

Presentation

Operator

Good day ladies and gentlemen, and welcome to the second quarter 2010 pSivida Corp earnings conference call. My name is Erica, and I'll be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of the conference. (Operator Instructions). I would now like to turn the presentation over to your host for today's call Ms. Lori Freedman Vice President, Corporate Affairs, General Counsel and Corporate Secretary. Please proceed.

Lori Freedman

Thank you Erica. Good afternoon everyone and thank you for joining us. After the markets closed toady we released the second quarter financial results for pSivida. If you do not have a copy of the release, one may be found in the investor section of our website at www.psivida.com. On the call with me today are Dr. Paul Ashton, President and Chief Executive Officer of pSivida and Len Ross Vice President of Finance and Principal Accounting Officer.

Before I hand the call over to Paul, I need to remind everyone that some of our prepared remarks as well as answers to your questions will be forward-looking in nature. These 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 detail 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 fiscal 2009 annual report on Form-10K which was filed on September 25, 2009. The company undertakes 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 would like to turn the call over to Paul.

Paul Ashton

Hi thank you Lori and welcome everyone. We're very pleased to be hosting our earnings release conference call and I appreciate all of you taking the time to join us today as we discuss the results of our second quarter of fiscal 2010. We've had a very good quarter as we continued to drive our business forward and I'll start today with a brief overview of pSivida and our business strategy. As many of you know, we at pSivida developed a miniaturized, sustained release ingestible growth delivery products. These are products that can be small enough to be inserted into the body via an incision as small as 2000s of an inch across and have the ability to release drugs for months or years after a single application. Our goal is to become the world's leader in miniaturized drug delivery systems.

Our main focus has been on developing products for the back of the eye. These are diseases which we believe are very serious and underserved and represent an estimated multi billion dollar market opportunity. An isolated 10 million people suffer from potentially blinding back of the eye diseases in the US alone. A major problem in developing new treatments for back of the eye diseases has been the difficulty of achieving therapeutic drug levels at the target sight. Eye drops simply don't penetrate to the back of the eye and have never been clinically proven to achieve therapeutic drug levels and while taking drugs systemically, i.e. orally or intravenously, while that condition gives therapeutic ocular levels, the amount that has to be taken this way also opens the doors to unacceptable systemic toxicities.

Over the past few years, people have resorted to injecting drugs directly into the eye. While this is effective, repeated injections into the eye in some cases every couple of months for the rest of a patient's life, this is hardly ideal. We have successfully developed tiny drug delivery inserts that can maintain therapeutic drug levels in the back of the eye for months or years after a single application. We have developed two of the only three products approved by the FDA that provides long-term main drug delivery to the eye. We now have a pipeline with multiple products in development for eye diseases and also localized conditions. There are now several generations of products and these reflect the on-going devolution of our cure Durasert technology.

Our first generation Durasert product BrachySil was approved by the FDA in 1996 for the treatments of CMV retinitis. That's an AIDS-associated infection. Our second generation Retisert product was approved for the treatment of post dated UVI just in 2005. These products are both licensed to and sold by Bausch & Lamb. Our third generation and most advanced Durasert product currently in clinical trial is Iluvien. Iluvien is not completing Phase III clinical trials in diabetic muscular edema, a huge indication affecting approximately a million patients in the US alone. About 10% of all diabetics will develop DME some stage in the disease. In terms of dollars, the DME market is being estimated at between $1.5 billion and $3 billion annually in the US and there are currently no FDA approved drugs for this disease.

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