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EyePoint Pharmaceuticals, Inc. (EYPT)

Q2 2013 Earnings Call· Wed, Feb 6, 2013

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Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to the second quarter 2013 pSivida Corporation earnings conference call. At this time, all participants are in a listen-only mode. Later, we’ll have a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star and then zero on your touchtone telephone. 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.

Lori Freedman

Analyst

Thank you, Mary. Good afternoon everyone and thank you for joining us. After the market closed today, we released our second quarter financial results for fiscal 2013. A copy of the release is available in the investor section of our Web site 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 or 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 statements. For more detailed discussion of the risk factors that could impact our future results and financial condition, I’ll 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.

Paul Ashton

Analyst

Thank you, Lori, and welcome everyone as we discuss the results of our second quarter of fiscal 2013. I’d like to start with focusing you on our strategy. As previously discussed, we have begun our transition from a license-based drug delivery company relying exclusively on partnerships to develop and commercialize our products to a specialty pharma model. We plan to use some of the revenues generated and lessons learned from our partnerships to develop some of our own products ourselves. Of course, we will still look to enter into collaboration agreements where it’s appropriate for example in the development of new chemical entities or for products requiring complex or very expensive clinical trials. But increasingly, we look to develop our own products. Now, moving from strategy to tactics, our lead development product, which we plan to move forward ourselves without a partner is our micro-insert to treat posterior uveitis. We expect it will begin Phase III clinical trials next quarter on schedule. We are continuing to engage in pre-clinical studies of Tethadur, our technology system to deliver proteins and antibodies, and we’re encouraged by the results so far. Finally, Alimera Sciences, our partner on the ILUVIEN for diabetic macular edema, has announced plans for its direct commercial launch in Germany by the end of this quarter. ILUVIEN for DME has now received marketing authorization in Germany, France, Austria, Spain, Portugal, and the U.K. With respect to U.S. approval, Alimera has reported that it intends to resubmit the NDA later this quarter. US approval would trigger a $25 million milestone payment to us and a profit share. Finally, with respect to our capital resources, we ended the quarter with over $15.7 million in cash and cash equivalents, which we believe should enable us to maintain our current and planned operations into…

Len Ross

Analyst

Thank you, Paul. Good afternoon, everyone. I will briefly review our second quarter fiscal year 2013 results reported earlier today, starting with our financial position. As Paul mentioned, at December 31, 2012, we had cash, cash equivalents, and marketable securities of $15.7 million, a net decrease of $1.9 million during the quarter. We anticipate that these capital resources, together with expected royalty income from Bausch & Lomb, should enable us to fund our current and planned operations into the first quarter of calendar year 2014, including planned Phase III clinical trials of the posterior uveitis micro-insert expected to commence during the current fiscal year. Funding of our operations beyond then is expected to depend on the amount and timing of cash receipts pursuant to our existing collaborations with Alimera, Bausch & Lomb, and Pfizer, as well as any funding from any possible future collaborations and/or financing transactions. As Paul mentioned, Alimera has reported its intention to proceed with the direct commercial launch of ILUVIEN for DME in Germany in the current quarter and in the UK and France later in 2013. As reported previously, we are entitled to a 20% share of net profits as defined, measured quarterly on a country-by-country basis under the terms of our collaboration agreement. However, we do not know if and when Alimera will achieve net profits in each EU country where it has marketing approval and intends to commercialize ILUVIEN directly or the amount or timing of any amounts we might receive. Turning to our results for the second quarter ended December 31, 2012, we reported revenues of $585,000 compared to $630,000 for the same period last year. Collaborative research and development revenue was down slightly with lower recognition from the restated Pfizer agreement because we have increased our estimates of the cost and…

Paul Ashton

Analyst

Great. Thanks, Len. So to sum up, it’s been another excellent quarter for us as we start the transition in our strategy from a license-based drug delivery company to a specialty pharma company. We are making good progress in preparing for the two pivotal Phase III clinical trials for micro-insert for posterior uveitis, which we expect will begin enrolling patients on schedule next quarter. We continue to be pleased with our preclinical research on our Tethadur peptide protein delivery system and are working with a major player in ophthalmic applications of this platform technology. ILUVIEN for DME is also progressing with first commercial sales in Germany expected next month followed by launches in the UK and France later in the year, and we expect to see Alimera refiling the NDA for ILUVIEN for DME in the US later this quarter. At this point, we’d be happy to take your questions. Operator, would you please initiate the Q&A portion of the call?

Operator

Operator

(Operator Instructions) I show no questions at this time. Can I turn the conference back to Paul Ashton for closing remarks?

Paul Ashton

Analyst

Great. Thank you. Okay, I’d like to thank all of you for joining us today and I look forward to speaking with you again next quarter. In the meantime, if you have additional questions, please feel free to contact us. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude the program, and you may all disconnect at this time.