Earnings Labs

EyePoint Pharmaceuticals, Inc. (EYPT)

Q1 2013 Earnings Call· Thu, Nov 8, 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

+0.70%

1 Week

-8.45%

1 Month

-8.45%

vs S&P

-12.36%

Transcript

Operator

Operator

Good day ladies and gentlemen, and welcome to the Q1 2013 pSivida Corp. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time (Operator Instructions). As a reminder, today’s conference is being recorded. I would now like to introduce your host of this conference call, Ms. Lori Freedman. you may begin ma’am.

Lori Freedman

Management

Thank you, Kevin. Good afternoon everyone and thank you for joining us. After the market-close today, we released our first quarter financial results for fiscal 2013. A copy of the release is available on the Investors section of our website at www.psivida.com. On the call with me today are 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 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 detailed discussion of the risk factors that could impact our future results and financial conditions, I’ll 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 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

Management

Great, thank you, Lori, and welcome everyone as we discuss the results of our first quarter of fiscal 2013. This was another good quarter for us. Here are some of the headlines and I’ll go into some detail on each of these in a moment. First, we’re making good progress in the planning of the two pivotal Phase III clinical trials for posterior uveitis micro-insert. As you will recall, the FDA only accreted to proceed directly into these trials. Next, we’re continuing to make strides in the development of our Tethadur platform technology for the delivery of peptides and proteins. Third Alimera Sciences, plans for the direct commercial launch of ILUVIEN in the EU next year and expected resubmission of the NDA in the U.S. in the first quarter of 2013. And finally, with respect to our capital resources, we ended the quarter with over $17.6 million in cash and cash equivalents, following a registered direct offering in August 2013. Now I’ll go into some details, the uveitis affecting the back of the eye or posterior segments is considered to be the third or fourth largest cause of blindness in the U.S. with an estimated 30,000 cases of blindness despite affecting less than 200,000 people in the U.S. So it’s an open indication of that nasty one. The uveitis is an inflammatory condition that can have many triggers or it can occur spontaneously, but in many cases, it’s idiopathic. The disease is currently generally treated with off-label use of systemic drugs. But there are also two FDA approved products to treat the disease, our product Retisert, licensed and sold by Bausch & Lomb and OZURDEX sold by Allergan. Unfortunately, neither of these products succeeded in significantly changing the malignance of the disease from those patients. As a result, uveitis patients…

Leonard S. Ross

Management

Thank you, Paul and good afternoon everyone. I will briefly review our first quarter fiscal year 2013 results reported earlier today, starting with our financial position. At September 30, 2012 we had cash, cash equivalents and marketable securities of $17.6 million, a net increase of $3 million during the quarter, which included $4.7 million of net proceeds from our August 2012 registered direct share offering. We anticipate that these capital resources, together with expected royalty income from Bausch & Lomb, should enable us to fund our operations, that’s currently planned through the end of calendar year 2013, including plans for Phase III clinical trials of a posterior uveitis micro insert. The Company’s funding of its operations beyond 2013 will depend on the amount and timing of cash receives pursuant to our existing collaborations with Alimera, Bausch & Lomb and Pfizer and any potential future collaboration agreements, as well as any possible future financing transactions. As Paul mentioned Alimera has reported its intention to proceed with the direct commercial launch of ILUVIEN for DME in Germany, the UK and France during calendar year 2013. As you know, we are entitled to 20% share of net profits as defined, measured quarterly in a country-by-country basis under the terms of our collaboration agreement. However, we do not know either the amount or the timing of any such payments that we may receive. Turning to our results for the September 2012 quarter, we reported total revenues of $553,000, compared to $1.7 million for the same period last year. The revenue decrease was primarily due to the recognition of $1.1 million of revenue in the prior year period as a result of the July 2011 termination of a field-of-use license by Intrinsic. Actually offset by a $200,000 increase in royalty income from sales of Retisert by Bausch & Lomb. Research and development expense totaled $1.5 million for the September 2012 quarter, compared to $2.1 million in the prior year period. The substantial decrease was primarily attributable to reduced amortization of intangible assets, resulting from our $14.8 million, intangible asset impairment write-down at December 31, 2011. General and administrative expense totaled $1.6 million for the quarter ended September 30, 2012, compared to $2.1 million last year. This year-over-year decrease was primarily attributable to our lower levels of stock-based compensation and professional fees. Net loss for the three months ended September 30, 2012 was $2.6 million, or $0.11 per share, compared to a net loss of $2.4 million or $0.12 per share for the prior year quarter. I will now turn the call back over to Paul.

Paul Ashton

Management

Thanks Len. So to sum up, it’s been an another excellent quarter. We are making good progress in the filing of the two pivotal Phase III clinical trials for micro insert for posterior uveitis. We are continuing to make progress with 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 the Alimera financing and the announced plan for the commercial launch of ILUVIEN for they may in Germany in Q1 2013, followed by launches in the U.K. in Q2 and France in Q3. Alimera has also announced plan to resubmit the NDA for ILUVIEN for diabetic macular edema to the FDA in Q1 2013. So 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) Our first question comes from Juan Sanchez of Ladenburg. Juan F. Sanchez – Ladenburg Thalmann Securities: Couple of questions, the first one is just a clarification is the injector that ILUVIEN uses different injector, ILUVIEN using the uveitis product. And the second question will be whether or not Alimera has shared with you the analysis of their plan to submit to the FDA and if so you any judgment about the quality of the submission?

Paul Ashton

Management

Well. First with respect to the injector yes, it’s a different injector than the one which Alimera plans to commercially launch. The primary difference is the needle itself, is significantly smaller. Alimera, ILUVIEN injector is a 25 gauge. We've not go back down to a 27 gauge. It kind of depends on how you use, you also injecting eye balls, but it's certainly very easier to inject with small gauge needles than a larger needle. With respect to your second question, will we see the resubmission Alimera filing, yes we will get to review that under our agreement with Alimera, I have not yet seen it. Juan F. Sanchez – Ladenburg Thalmann Securities: Thank you, guys.

Operator

Operator

(Operator Instructions) And I am not showing any further questions at this time.

Paul Ashton

Management

Okay, then, I’d like to thank you all for joining us today and 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. Thanks very much.

Operator

Operator

Ladies and gentlemen that concludes today's presentation you may now disconnect and have a wonderful day.