EyePoint Pharmaceuticals Inc (EYPT) 2012 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the first quarter 2011 pSivida Corporation earnings call.

(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, Miss Lori Freedman, Vice President of Corporate Affairs and General Counsel.

Please produce.

Thank you, Modesta.

Good afternoon, everyone, and thank you for joining us.

After the market closed today, we released our first quarter 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 VP of Finance.

Before I hand the call over to Paul, I need to remind everyone that some of our prepared remarks, as well as answers to your questions, will be forward-looking in nature.

These 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 condition, I refer you to our filings with the SEC, including our fiscal 2011 Annual Report on Form 10-K, which was filed on September 13, 2011.

The Company undertakes 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.

Alright, thank you Lori and welcome, everyone, as we discuss the results of the first quarter of fiscal 2012.

We ended the first quarter with $21.3 million in cash, approximately $6.0 million higher than this time last year, reflecting the fund raise in January.

Len will take us through the detailed breakdown of the financial quarter -- sorry.

Len will take us through the breakdown of the quarterly financials in a moment.

First, I'd like talk to you about our development programs.

As we reported, we have a very full plate with three clinical stage product candidates for the treatment of back of the eye diseases.

These are ILUVIEN for diabetic macular edema, or DME, being developed by our licensee Alimera Sciences; a product we're developing independently to treat uveitis affecting the posterior of the eye; and a product we're developing glaucoma and ocular hypertension.

This last one is being developed in collaboration with Pfizer.

Turning to ILUVIEN, which, as you know, is our most advanced product, Alimera has submitted the new drug application and is awaiting a response from FDA.

The PDUFA date is November 12, 2011.

Last week Alimera announced that in September 2011 it commenced a physician utilization study of the inserter it intends to use in the commercialized ILUVIEN and this is in response to a request from the FDA.

Alimera reported that it has enrolled 54 of the targeted 100-patient eyes in this study, evaluating the safety and utility of the commercial version of the inserter.

Data from this study may be required by the FDA for its consideration of the approval ILUVIEN in DME.

Alimera also reported on the status of the European approval being sought for ILUVIEN for DME.

In July 2012, Alimera submitted a marketing authorization application to the Medicines and Healthcare Products Regulatory Agency, or MHRA in the UK, and to regulatory authorities in Austria, France, Germany, Italy, Portugal and Spain.

In July of 2011, Alimera submitted draft responses to questions raised by the MHRA and other health authorities and, in September, met with the MHRA to discuss those responses.

Alimera reported that it expects to submit a formal response to all questions raised by the end of November and, based on this response, Alimera expects the MHRA to make a recommendation on approvability by the end of this year.

Now, let's move on to our posterior uveitis product.

Posterior uveitis is an inflammatory condition which can be extremely serious.

In the United States, this disease has been estimated to affect 175,000 people and is responsible for approximately 30,000 cases of blindness.

Our product to treat this disease uses the same injectable micro insert, with a different inserter, of ILUVIEN for DME.

Our collaboration agreement with Alimera allows us to reference the ILUVIEN DME regulatory filings and this provides the potential for an abbreviated clinical development and regulatory process for the posterior uveitis application.

In an investigator- sponsored trial in posterior uveitis opened in September 2011.

Our proposed products to treat glaucoma as an injectable, bioerodible sustained-release insert delivering latanoprost.

It's currently being studied in a dose-ranging study.

We granted Pfizer an exclusive option, under varying circumstances, the license, the development and commercialization worldwide for this insert for human ophthalmic diseases other than uveitis.

We're also continuing to work on BioSilicon.

We remain focused on advancing the Tethadur BioSilicon System, which is designed to deliver large biologic molecules, including peptides, proteins, and antibodies, and they can deliver those on a sustained basis.

So, to summarize, we continue to advance our business strategy of advancing products toward late-stage, including potentially to approval, before looking to out-license our partner.

We believe the optimal timing for partnering varies and is based on many factors, including our views on the complexity of the clinical and regulatory process, the cost of developing the product, the cost and availability of capital, the cost and complexity of sales and marketing and the products' overall strategic fit.

We believe that our financial position is relatively strong and that we have adequate cash to execute our product development plans at least until calendar 2013.

Approval of ILUVIEN for DME by the FDA and/or EMEA will obviously be a huge step forward for us.

Progress in the clinical trials of our products designed to treat glaucoma and uveitis will also be very important and the potential non-ophthalmic applications our Durasert System, as well as the potential ophthalmic and non-ophthalmic applications of the Tethadur Protein Delivery System offers a huge blue sky potential for our Company.

Again, ultimately, pSivida is all about products.

Going forward, we believe our value will continue to be derived from products we are developing.

And with that thought, I'm going to hand you over to Len.

Thank you, Paul, and good afternoon, everyone.

I will briefly review with you the first quarter results, which we reported earlier today, starting with our financial position.

At September 30, 2011, we reported cash, cash equivalents and marketable securities of $21.3 million, a net increase of $2.8 million from $24.1 million at June 30, 2011.

As Paul mentioned, this is approximately $6.0 million higher than at this same time last year.

We continue to believe that these cash resources will support our currently planned operations until at least calendar year 2013.

If ILUVIEN is approved by the FDA, the resulting $25 million milestone payment due from Alimera would substantially enhance our capital position.

For the quarter ended September 30, 2011 we reported revenues of $1.7 million, compared to $476,000 in the first quarter of last year.

Revenues for this year's first quarter were primarily the result of the recognition of previously deferred collaborative research and development from two collaborations.

First, the Pfizer agreement, which was amended and restated in June 2011 and second, the intrinsic Field of Use License, which was terminated in July 2011.

Revenues in the prior year's first quarter consisted primarily of Retisert royalty income earned from Bausch and Lomb.

Research and development totaled $2.1 million for the three-month period ended September 30, 2011, compared to $1.7 million in the prior year quarter, primarily attributable to increased personnel expenses and costs related to the ongoing Latanoprost Phase I/II clinical trial.

General and administrative expense totaled $2.1 million in the first quarter this year, compared to $2.2 million last year.

Non-operating income was $49,000 for the quarter ended September 2011, compared to of $336,000 in the prior year quarter.

The decrease was primarily attributable to lower noncash income in the current year period of the change in the fair value of derivatives related to outstanding Australian dollar investor warrants.

As we've noted previously, the remainder of these warrants will expire in July 2012 unless earlier exercised.

Net loss for first quarter of fiscal 2011 was $2.4 million, or $0.12 per share, compared to a net loss of $3.1 million, or $0.17 per share for the prior year quarter.

Higher weighted average outstanding shares in the current period was due to the January 2011 issuance of 2.2 million shares in the registered direct offering.

I will now turn the call back over to Paul.

Okay, thanks, Len.

To sum up, we believe we're making strong progress in developing our product pipeline with clinical-stage product candidates for DME, glaucoma, and posterior uveitis, three of the leading causes of blindness in the U.S.

Today we reported at the end of our first fiscal quarter for 2012, September 30th, we had cash of approximately $21.3 million and that's an increase of approximately $6.0 million over the prior year.

We will continue to manage our cash resources carefully.

So I believe that we're well positioned for an exciting time ahead and I look forward to speaking with you all again next quarter.

At this point, we'd be happy to take your questions.

(Operator instructions) Juan Sanchez, Ladenburg Thalmann

Good evening, guys.

Hi Ron, how's it going?

Good.

Just the same question in respect to the physician survey that is going on out there.

Why isn't this a condition for approval?

Why do you think there is a possibility that the FDA could approve this device before seeing the data?

The second question is what do you think the FDA wants to see and if their question is when do you think Alimera can generate the final data?

Okay.

So, attempting to answer those questions, obviously we've heard that Alimera believes that they can get approval based on the current package that doesn't include this survey -- sorry, this study and that the study will be necessary for final marketing rather than approval.

Now, Juan, as I hope Alimera's right, I haven't been privy to all of those conversations with the FDA.

That would, however, be somewhat unusual.

It wouldn't be a total surprise if the FDA wanted to see these data.

So having said that, what do you think the FDA wants to see?

I haven't been privy to those conversations with the agency.

Okay.

You have to remember that Alimera Sciences are really leading the charge here with correspondence and communications with the FDA.

I don't get to attend any of those meetings.

When do you -- when are they going to deliver this data, by when?

I'm not sure.

I believe they said the plan is to have the study completed by the end of this year.

So far they've enrolled 53 or 54 of the targeted 100 patients.

And this device, this injector is the same one that you guys used in the Phase III, or this is a different injector?

No, it's a different inserter.

So this inserter is more suitable, apparently, for commercialization than the one that was used in the Phase III, but again, this is a decision that Alimera will have made.

So when did they incorporate the new device into their filing?

After the first NDA, or it is a recent change?

I believe the device was incorporated in the first filing.

Okay.

(Operator instructions) Morris Johnson, American Wealth Management

Hey, Paul.

Hi.

Hey.

Could you clarify the PDUFA date?

Is that just the approval of the drug or does the PDUFA include marketing, ability to go ahead and market and sell the product?

Normally, a PDUFA date is the date which you can expect to hear from the FDA on approval.

So, in this case, the FDA could announce that they approve it, but then Alimera would have to wait for subsequent approval on the ability or the different -- the 100 eyes and ophthalmologists in that study?

To market and sell?

That's what Alimera stated recently and again, that's presumably informed by conversations they've had with the agency.

More normally the agency gives you an approval and the approval is to market the product.

Right.

Okay.

Well, that's alright.

Thank you.

(Operator instructions) It appears that does conclude our Q&A portion of the call.

I would now like to turn it back over to Paul Ashton for any closing remarks.

Alright.

Well, there being no more questions, thank you very much for joining us today.

I look forward to speaking with you all again in the next quarter.

In the meantime, should you have any additional questions, please don't hesitate to contact us.

And thank you very much.

Ladies and gentlemen, that concludes today's conference.

Thank you for your participation.

You may now disconnect.

Have a great day.