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EyePoint Pharmaceuticals, Inc. (EYPT)

Q4 2013 Earnings Call· Wed, Sep 25, 2013

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Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to the pSivida Corporation Fourth Quarter 2013 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. (Operator Instructions) As a reminder, this conference call is being recorded for replay purposes. I would now like to turn the conference over to your host for today's conference, Ms. Lori Freedman, General Counsel and Vice President of Corporate Affairs. Ma'am you may begin.

Lori Freedman

Management

Thank you, Mary. Good afternoon everyone and thank you for joining us. After the market closed today, we released our third 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 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 facts 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 condition, I 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 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

Management

Thank you, Lori, and welcome everyone as we discuss the results of fiscal 2013 and fiscal 2013 fourth quarter. This was another good quarter for us as we continue our transition to a product based Specialty Pharma company, -- the one that still capitalizes on collaborations and licenses as appropriate. Here are some of the highlights; we have started our pivotal Phase III program for our own lead development product, Medidur for posterior uveitis. Second highlight, preliminary data from the Phase I/II investigator-sponsored study of Medidur was very encouraging. Third, our partner product ILUVIEN went on sale in Germany and the UK for the treatment of chronic Diabetic Macular Edema or DME. Four, following a re-filed NDA, ILUVIEN is under review by the FDA. Five, we're continuing to make progress with our Tethadur delivery system for peptides, proteins and antibodies. And six, after the close of quarter we completed a public offering of our common stock raising gross proceeds totaling $10.8 million; so, on the call today I'll provide you with some more details on these highlights before handling over to Len, who will take us through the financials. Before I go into the details though let's talk about the strategic direction the company is heading in. Our goal is to make the transition from a technology-for-hire company that simply licenses out all of its technology to a specialty pharma company that develops and sells its own products. So far we've done a great job in working with partners to advance our technologies, while retaining the freedom to develop our own products. Cash received from partners has greatly reduced our cash money. Over the last five years, we've received approximately $50 million from partners, in contrast over the same period we've only raised approximately 27 million from equity financings and…

Len Ross

Management

Thank you, Paul and good afternoon everyone. I will briefly review our fourth quarter and fiscal year 2013 results, reported earlier today starting with our financial position. As Paul mentioned in June 30, 2013 we had cash, cash equivalents in marketable securities of 10.3 million, and net decrease of 4.3 million compared to 14.6 million at June 30, 2012. In July 2013, we added to those capital resources with a $10.8 million public offering of our common stock. We anticipate that the combination of these capital resources, expected Royalty income from Retisert, and other expected cash inflows under existing collaboration and valuation agreements will enable us to fund our current and planned operations through calendar year 2014. This includes expected cost through that year of Phase III clinical trials of the Medidur for posterior uveitis product. The first of which commenced in 2013 that excludes any potential milestone or net profit recites under the Alimera collaboration agreement. Funding of our operations beyond calendar 2014 will depend on the amount and timing of payments we may receive under our collaboration agreement with Alimera as well as other existing and any future collaboration or valuation or other agreements and or any financing transactions in which we may engage. Although Alimera has commenced sales of ILUVIEN for DME in Germany and the UK and announced its plan launch timing for France, we don’t know if or when Alimera will achieve net profits in any of these countries or the resulting amounts we might receive. Turning out to our full year fiscal 2013 results; revenues decreased by 1.4 million to approximately 2.1 million for the year ended June 2013 compared to 3.5 million for the same period last year. Collaborative research and development revenue accounted for all the decrease which consisted primarily of 1.1…

Paul Ashton

Management

Thanks Len. So to sum up, it’s been an excellent year and quarter for us. Key points are: one, commencement of our Phase III program for Medidur for the treatments of posterior uveitis; two, we see a interim data from a Phase I/II investigator-sponsored study supportive of our hypothesis that Medidur will show similar efficacy to Retisert but with the improved side effect profile of ILUVIEN; three, the ILUVIEN product is now being marketed by Alimera in the EU. We look forward to the results of the FDA to view Alimera’s resubmission of the NDA due on October 17; and four, we continue to be pleased with our preclinical research on our Tethadur peptide protein delivery system and are working with a global biopharmaceutical company on ophthalmic applications of this platform technology. 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

Certainly. [Operator Instructions] And we have a question from Greg [indiscernible]. Your line is open.

Unidentified Analyst

Analyst

Good afternoon, everyone. Thanks for taking my question. Paul, congrats on a great quarter.

Paul Ashton

Management

Thank you.

Unidentified Analyst

Analyst

If you could remind me in terms of the profit share arrangement you have with Alimera and in terms of how we should model you’re being able to receive your share of the profits with regards to sales in Europe for 2014. Would you expect that at some point you might be able to receive a portion of the sales?

Paul Ashton

Management

I would certainly hope so. With respect to how the precise details of how the profits works and we’ll do better than to answer your question I will pass you over to Lori Freedman who can provide furthermore granularity.

Lori Freedman

Management

Hey Greg. So the way the profits work is obviously it’s a profit foot or net profits which is basically gross profits less sales and marketing. And it’s on a country by country basis. So the net profit our share’s net profit in Germany will not be offset by commercialization cost in any of the other countries. As to what those numbers are going to look like for 2014, we obviously don’t have that information yet in a way that we can pass along to other people. So Alimera keeps that nice and tight and we contractually are unable to give away any of that information.

Unidentified Analyst

Analyst

Okay, great. Thank you very much. Maybe a follow up just on your uveitis program, congrats on getting that program started and the details on time lines when you do think it would be in terms of guiding when we might be able to see first data from that trial? Is there any quarter in 2014 or beyond that you think would be reasonable for us to expect to hear from pSivida?

Paul Ashton

Management

We anticipate it will take one year to recruit, so that would be essentially a year from now to think will it finish recruiting. And then it’s a one year follow up before the primary end point. We are currently not planning to do an interim analysis although I guess we could certainly consider that. We don’t anticipate that we’re going to have too many problems with [p-values] so whenever you do an interim analysis it cost you something in terms of your statistical power in the study. And as we believe that the study is already statically overpowered to show efficacy we probably have a bit of p-value as it were to spare. We are not currently anticipating that although we could certainly perform an interim analysis at some point should we deem it appropriate all the lines to do so.

Unidentified Analyst

Analyst

Okay and maybe a follow up on that assuming you get an approval or Alimera gets an approval for ILUVIEN for diabetic macular edema does that change your thoughts around perhaps doing an interim analysis in Uveitis?

Paul Ashton

Management

There is a few things that may affect our decision to do an interim analysis that is certainly one of them. There are some other factors I think you probably get a good view of likely data when the one year results that they investigate response and study announced and I would anticipate the results of that study will give into the (inaudible) meeting which is typically held in May 2014. Perhaps, likely to be the first data from 12-month follow-up of a certain number of patients. (inaudible) was doing an interim analysis will be that you have a weighing follow-up time with your patients, so it can be a little difficult to interpret although having said that the [pSivida] sponsored data that we have just seen in terms of reduction in inflammation and improvement in innovation is, I was extremely pleased with that.

Unidentified Analyst

Analyst

Maybe switching to financials; it will be my last question, is there any particular guidance around P&L items for 2014?

Paul Ashton

Management

No we don’t typically give guidance. As you know -- at this, for companies of our type, there are events that can occur that can have a very significant impact. And if you do a licensing deal with someone then that can be a pretty damn big impact. But you never know that you have a deal until the wires clears in your account. So it’s very difficult to give guidance on those things they can evaporate just when you think you have a deal sometimes.

Unidentified Analyst

Analyst

Maybe last question just on R&D spend you are seeing a pickup in R&D spend in the fourth quarter relative to your prior three quarters as you continue to conduct that first Phase III for a posterior uveitis directionally any comments around R&D spend as 2014 evolves?

Paul Ashton

Management

Yes it’s going to o up; it’s not going to explode. The total cost of that trial and generally the total cost of these kinds of trials is about $100,000 per patient. And this is 120 patients, so that you can do the math yourself, it is about 12 million bucks plus or minus. And that cost is spread over the total duration of the trial including the follow-up periods although it is lumpy some quarters are obviously higher than others. Now these trials although the primary endpoint is 12 months and we can submit for approval without 12 month primary endpoint data, the actually duration of the trial is 3 years. So that $12 million will be spread over a considerable period of time but not evenly. All of that is giving you information but perhaps not answering your question directly. So I apologize.

Operator

Operator

(Operator Instructions)

Lori Freedman

Management

Okay well there being no more questions I would like to thank you all for joining us today. I look forward to speaking with you again next quarter. In the meantime, if you have any additional questions please feel free to contact us. And thank you.

Operator

Operator

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