Earnings Labs

EyePoint Pharmaceuticals, Inc. (EYPT)

Q4 2012 Earnings Call· Tue, Sep 25, 2012

$13.45

-1.10%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-1.80%

1 Week

-1.80%

1 Month

-7.78%

vs S&P

-5.93%

Transcript

Operator

Operator

Good day ladies and gentlemen and thank you for standing by and welcome to the pSivida Corporation’s Fourth Quarter 2012 Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct the question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder today’s conference may be recorded. It's now my pleasure to turn the floor over to Lori Freedman. Please go ahead.

Lori Freedman

Analyst

Thank you, Huey. Good afternoon everyone and thank you for joining us. After the market closed we released our fourth quarter and full-year financial results for fiscal 2012. A copy of the release is available 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 maybe 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 he results and other expectations express 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 conditions, I refer you to our filings with the SEC including our quarterly report on Form 10-Q for the quarter ended March 31, 2012. We undertake 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’d like to turn the call over to Paul.

Paul Ashton

Analyst

Great. Thank you, Lori. Welcome everyone as we discussed the results of the fourth quarter of fiscal 2012. This was another excellent quarter for us. Here are some of the headlines. First, the FDA cleared IND for the product for independently developing for the treatments of uveitis affecting the posterior uveitis segment permitting us to move directly into Phase III clinical trial. Second, Alimera Sciences have continued to make progress on the commercialization of the ILUVIEN for DME in the EU. Marketing and authorizations have not been received in five EU countries and the commercial launch is planned for Germany, France and the UK in 2013. Alimera has also reported in France to resubmit the NDA in the U.S. Third, we have made good progress on Tethadur, our peptide protein delivery system. We announced the execution of a funded technology evaluation agreement with the large biopharmaceutical company our first for this technology. Number four is of course cash. We ended the quarter with over $14 million in cash and subsequently raised some additional 4.7 million in a registered direct offering. Okay. So let’s get into some of the details. The uveitis affecting the posterior uveitis segment that’s the back-of-the-eye is a nasty disease. It affects just under 200,000 people in the U.S. but is one of the leading closes of vision loss, about third or four in the U.S. It's estimated as there are about 30,000 cases of blindness in the U.S. due to posterior uveitis. Uveitis is an inflammatory autoimmune disease that can have many triggers one can develop in the felicitation with diseases like lupus or MX or a variety of other conditions. Sometime they can be a genetic component such as the case in Behcet’s disease. And in many cases it's idiopathic. Thirdly, the disease in normally…

Len Ross

Analyst

Thank you, Paul and good afternoon everyone. I will briefly review our fourth quarter and fiscal year 2012 results reported earlier today. Starting with our financial position. As Paul mentioned at June 30, 2012 we had cash, cash equivalence and marketable securities of 14.6 million and net decrease of 9.5 million compared to 24.1 million at June 30, 2011. We anticipate that these capital resources together with the 4.7 million net proceeds of our recently completed registered direct offering and expected royalty income from Bausch & Lomb should enable us to fund our operations as currently planned through the end of calendar year 2013. Alimera has indicated its intention to launch sales of ILUVIEN for DME directly in Germany, the UK and France during calendar 2013. However, the timeframe and amounts of the 20% share of net profits is defined measured quarterly on a country-by-country basis to which we would be entitled under the terms of our collaboration agreement are uncertain. Our ability to fund planned operations beyond them including Phase III trials of posterior uveitis micro-insert will depend on the generation and timing of net profits from Alimera’s commercialization of ILUVIEN for DME in the EU and potentially in the U.S. or our ability to otherwise timely secure additional capital resources. Turning to our results, for the year ended June 30, 2012 we reported total revenues of 3.5 million compared to 5 million for the same period last year. The revenue decrease was primarily due to recognition of 3.3 million of revenue in fiscal 2011 as a result of our amended Pfizer collaboration agreement compared to 754,000 recognized in the current year. This was partially offset by 1.1 million of collaborated research and development revenue that we recognized in fiscal year 2012 as a result of the July 2011…

Paul Ashton

Analyst

Great. Thanks Len. So, to sum up, it's been an excellent quarter. The R&D for micro-insert for posterior uveitis has been cleared by the FDA. ILUVIEN has received marketing authorization in five EU countries and our licensee Alimera Sciences has said its plans to launch in France, Germany and the UK in 2013. They have reported agreements on a $40 million equity financing contingent on shareholder approval that will provide them with the cash to launch. After having met with the FDA, Alimera reported plans to resubmit the NDA for ILUVIEN. The clinical trial for our bioerodible glaucoma product in ongoing and we are continuing to work on developing Tethadur our peptide protein delivery system. And last but certainly not least we ended the quarter with 14.6 million in cash and in August raised some additional 4.7 million to supplement our cash position. At this point we would be happy to take your questions. Operator would you please initiate the Q&A portion of the call?

Operator

Operator

(Operator Instructions) Presenters I’m showing no questioners on the phone queue, I’d like to turn the program back over to you for any additional remarks.

Paul Ashton

Analyst

Okay. Well, thank you all for listening. I can only presume that we did an excellent job of the update. So, thank you very much for your attention and I look forward to giving you further updates in our next quarter. Thanks very much.

Operator

Operator

Thank you, presenters. Again ladies and gentlemen this does conclude today’s conference. Thank you for your participation and have a wonderful day. Attendees may disconnect at this time.