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EyePoint Pharmaceuticals, Inc. (EYPT)

Q3 2012 Earnings Call· Wed, May 9, 2012

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Q3 2012 pSivida Corp. Earnings Conference Call. My name is Sonia, and I'll be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I would like to turn the call over to Lori Freedman, Vice President, Corporate Affairs. Please proceed, ma’am.

Lori Freedman

Analyst

Thank you, Sonia. Good morning, everyone, and thank you for joining us. Before the market opened today, we released our third quarter financial results for fiscal 2012, a copy of the release is available on the -- 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 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 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 quarterly report on Form 10-Q for the quarterly period ending December 31, 2011. 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 the third quarter of fiscal 2012. This was an excellent quarter for us. Iluvien, our lead development product received a positive outcome from the European regulators in the Decentralized Procedure and as we announced on Monday, this product has now received marketing authorization in Austria and the U.K. With additional approvals anticipated in the coming months in 5 other EU countries. We’ve also made good progress in our development stage products and we ended the third quarter with $16.5 million in cash. Len will discuss this further and take us through the detail breakdown of our cash position and the quarterly financials in the moment. First, I’d like to give some more details about our development program. With respect to Illuvien, the approval process in the EU is different from that in the U.S. So I shall summarize it for you. In the EU, Alimera, our development and commercialization partner in this program, applied for marketing approval for Illuvien for DME in 7 EU countries under the Decentralized Procedure or DCP. This review process was as we announced in February completed with the positive outcome and the final assessment report was issued by the reference member state, which in this case was the U.K., with agreements of the 6 of the concerned member states. And that report said that Illuvien is approvable for the treatment of vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to the available therapies. So the process is now in the national phase, during which the 7 participating countries separately issue the marketing authorizations. First to come in was Austria and as we announced on Monday, approval in the U.K was next. The timing varies country by country, but Alimera has…

Leonard Ross

Analyst

Thank you, Paul, and good morning, everyone. I will briefly review our fiscal year 2012 third quarter results we reported earlier today, starting with our financial position. As Paul mentioned at March 31, 2012, we had cash, cash equivalents and marketable securities of $16.5 million, a net decrease of $2.2 million from $18.7 million at December 31, 2011. We anticipate that these capital resources together with expected royalty income from Bausch & Lomb should enable us to maintain our current operations into fiscal year 2014. Our resources could be enhanced if Alimera successfully commercializes or sub-licensees commercialization of Iluvien for DME in the EU. However, the time frame and amounts that we would be entitled to receive from Alimera from such activities, under the terms of our collaboration agreement are uncertain. We expect to seek additional capital resources through possible new collaborative or licensing arrangements, and/or possible other agreements and transactions may include sales of assets or securities, and/or to reduce our capital requirements through possible adjustments to our operating plan. We currently do not intend to initiate pivotal multicenter clinical trials for our injectable insert designed to treat posterior uveitis without appropriate additional funding. Turning to our results for the fiscal third quarter ended March 31, 2012, we reported revenues $538,000, compared to $360,000 in the third quarter last year. The year-over-year revenue increase was primarily the result of the recognition of previously deferred collaborative research and development revenues from our June 2011 restated Pfizer agreement, as well as increased Retisert royalty income. Research and development expense totaled $1.5 million for the 3 months period ended March 2012, compared to $1.7 million in the prior year quarter, primarily attributable to lower amortization of intangible assets that resulted from the $14.8 million impairment charge in the second quarter. This was…

Paul Ashton

Analyst

Thanks, Len. To sum up a positive outcome of the review of Iluvien in the EU, obviously very welcome news. Marketing authorizations has already been issued in Austria and the U.K. And we expect marketing authorizations from the remaining countries in the coming months. We are very pleased upon Alimera. I have stated that it is the anticipated commercialization in the EU by the end of this calendar year. We continue to press -- progress our plans for Phase III program in the U.S. for our insert for posterior uveitis, which is the same insert approved in the EU for DME. As we set to our early stage programs, we believe we’re continuing to make progress of our clinical stage product for glaucoma and the protein delivery system continues to elapse. So at this point, we’d be happy to take your questions. Operator, would you please initiate the Q&A portion of this call?

Operator

Operator

[Operator Instructions] First question comes from the line of Suraj Kalia, Rodman & Renshaw.

Suraj Kalia

Analyst

Paul, one of the things, I was wondering if you could shed some color, maybe on fairly soon, Alimera’s part, what is the status of the FDA discussions on Iluvien? Is there some -- any wiggle room there?

Paul Ashton

Analyst

I would have to defer to Alimera on that, Suraj. My understanding is that Alimera would be planning to have a follow-up meeting to discuss the CRL with the FDA and I believe they’ve announced that.

Suraj Kalia

Analyst

Okay. So we won’t have some additional color for at least, maybe a few more months?

Paul Ashton

Analyst

I couldn’t comment.

Suraj Kalia

Analyst

And Paul, specifically, in terms of posterior uveitis, you mentioned, a shorter time line, shorter pathway should I say for a Phase III, could you remind us again in terms of how many patients are you looking at in the study, duration of follow-up, assuming funding is eventually at a place where you’re comfortable moving ahead?

Paul Ashton

Analyst

Ultimately, I can’t provide a great deal of color on that because we’re still in discussions with the FDA. So at some point, when we finish those negotiations I’ll be able to give you much more detail. I am expecting that those negotiations will be concluded relatively shortly.

Suraj Kalia

Analyst

Okay. And Paul, are we looking at any new technologies on the horizon that potentially your view as interesting maybe from an acquisition perspective, maybe from a competition perspective that we should keep an eye open for?

Paul Ashton

Analyst

So I’ve just come back from ARVO conference. There’s a couple of interesting technologies on display there, but they all seem to be at the pre-clinical stage in terms of drug delivery. So pre-clinical things, while they often look great and some of them no doubt will be great, it’s the timeline that is sometimes open to questions. There is obviously a great deal of focus now in drug delivery to the back of the eye. We look at the great advance that Regeneron -- the success that Regeneron is having with EYLEA product. Just for the people who do not know, EYLEA is a newly-approved fusion protein that’s, kind of, like an antibody for wet-AMD. It is injected into the eye about every 2 months. And as I recall, well, please go and check the press release because my understanding is that they expect to take 50% market share away from Regeneron’s products which is -- sorry – Genetech’s product. I do apologize. They’re expecting to take 50% market share from – Roche Genentech’s product, which is injected every 6 weeks. So that’s only a 2 or 3-week intravitreal [ph] injection and it’s having a huge impact on the clinical practice. So while we’ll presume that a much longer-term delivery system of the type that we are developing would be quite interesting. So there is clearly a lot of industry focus I think on long-term delivery for the back of the eye, just that currently I think we’re one of the few people who have been able to get it to work.

Operator

Operator

And the next question comes from the line of Juan Sanchez, Ladenburg.

Juan F. Sanchez

Analyst

One question about the Pfizer program for glaucoma, when do you think you finish this study and what are you looking for into dose-ranging study. I mean, our offering is being dictated [ph] on what’s the efficacy criteria for you to know there is – within a bit of margin. And the second question is you say that you are now planning to move in uveitis program before you raise some money or you find a partner, so how much is the cost of the pivotal program in uveitis?

Paul Ashton

Analyst

Well, so there’s 2 questions there, I think. To address the first one which is -- with respect to glaucoma, we’re expecting that will finish towards the end of this year.

Juan F. Sanchez

Analyst

Okay.

Paul Ashton

Analyst

That’s the current Phase I, II dose-ranging study. That’s primarily a safety study. But we are hoping to see and we would expect certainly to see some evidence of a efficacy-based on reduction in overall IOP. Probably that’s not going to be statistically significant, but it’s not going to be power [ph] to these statistics. This is a very small study. Based on that, that will allow us to pick 2 doses to go into the Phase II study that we had expected obviously sometime later. To get back to the question on uveitis, I’m sorry, could you repeat your question?

Juan F. Sanchez

Analyst

Yes. Well, how much will be cost of the pivotal program on uveitis?

Paul Ashton

Analyst

So that -- it’s still -- that is largely a function of the number of patients who are going to be required to enroll, which will also affect the potential timing. So that’s still a subject of discussion with the FDA.

Juan F. Sanchez

Analyst

Now, back to the glaucoma program, how much time does Pfizer have after this trial is done to take the option or not, you know what I mean?

Paul Ashton

Analyst

So the trial that we currently doing is a Phase I, II study.

Juan F. Sanchez

Analyst

Okay.

Paul Ashton

Analyst

After that we’ll do…

Juan F. Sanchez

Analyst

So, it’s after the next trial, not after this trial.

Paul Ashton

Analyst

That’s correct.

Operator

Operator

There are no further questions at this stage. [Operator Instructions] There are no questions coming through. I would now like to turn the call over to Paul Ashton for closing remarks.

Paul Ashton

Analyst

Well, I would like to thank you all for joining us today. And I look forward to speaking to you again next quarter. In the meantime, if you have any additional questions, please feel free to contact us and good morning. Thank you.

Operator

Operator

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Good day.