Earnings Labs

Ocular Therapeutix, Inc. (OCUL)

Q1 2015 Earnings Call· Fri, May 15, 2015

$9.13

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Transcript

Operator

Operator

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to Ocular Therapeutix's First Quarter 2015 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. It is now my pleasure to turn the floor over to Brad Smith, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Brad Smith

Chief Financial Officer

Thank you and good morning, everyone. Welcome to Ocular Therapeutix's first quarter 2015 earnings and business update conference call. This morning, we issued a press release providing details of the Company's financial results for the first quarter ended March 31, 2015. And we also provided an update on the plan path forward for OTX-DP a product candidate for the treatment of post-surgical ocular inflammation and pain. And the press release is available on the Investor portion of our website at investors.ocutx.com. Leading the call today will be Dr. Amar Sawhney, our President and CEO and Chairman, who will provide a detailed update on the OTX-DP Phase 3 clinical development program and also an update on the status of each of our other development programs, as well as upcoming anticipated milestones. Following Amar's remarks, I will provide an overview of the financial highlights for the first quarter of 2015 before we then open the call for questions. We are joined us this morning by Eric Ankerud who is our Executive Vice President of Clinical, Regulatory, and Quality as well as Scott Corning, our Vice President of Sales and Marketing. As a reminder, during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the Company's future expectations, plans and prospects, constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the Risk Factors section of our most recent quarterly report on Form 10-Q which was filed with the SEC earlier this morning. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today. I will now turn the call over to our Chairman, President and CEO, Amar Sawhney.

Amar Sawhney

President and CEO

Thank you, Brad. Good morning everyone and thank you for joining us today for our first quarter 2015 earnings call. Following a busy year of accomplishments in 2014 for Ocular Therapeutix we continue to advance four different clinical development stage programs for our lead product candidates, OTX-DP and OTX-TP as well as our preclinical programs for our sustained-release hydrogel depot for the delivery of anti-VEGF agents for the treatment of wet age-related macular degeneration or Wet AMD. We recently received conditional acceptance from the FDA for our proposed name DEXTENZA for our OTX-DP drug product candidate for the treatment of Post-Surgical Ocular inflammation and pain. We must now include this name in our planned NDA submission for further FDA review. Also, we are very, very pleased to announce that, following our most recent meeting with the FDA, we plan to proceed with an NDA submission in the second half of 2015 for an Ocular Pain Indication using the existing pain data from our clinical trials completed to-date. As a recap, in March and April 2015, we reported top-line efficacy results of our two Phase 3 clinical trials for DEXTENZA for the treatment of Post-Surgical Ocular Inflammation and Pain. The two primary efficacy endpoints was statistically significant differences between the treatment group and the placebo group for the absence of pain on day eight and absence of inflammatory cells on day 14. In the first Phase 3 trial which enrolled 247 patients, we met both primary endpoints for both ocular inflammation and pain with statistical significance. The second Phase 3 trial which enrolled 240 patients achieved the primary endpoint for the absence of pain at day eight, but did not achieve the primary endpoint for absence of inflammatory cells at day 14. While the treatment effect of pain and inflammation observed…

Brad Smith

Chief Financial Officer

Thanks, Amar. With regard to our cash and investment position, as of March 31, 2015, we had $67.4 million in cash, cash equivalents and marketable securities. Cash used in operating activities was $6.9 million for the first quarter 2015, compared to $4 million in the first quarter of 2014. We continue to believe that we have sufficient cash and cash equivalents to fund the company through the first half of 2016 and through several important clinical and commercial milestones with our product development programs, many of which Amar just covered. So just to highlight, they include submitting an NDA for DEXTENZA for the treatment of post-surgical ocular pain, initiating and completing patient enrollment in a third Phase 3 clinical trial for DEXTENZA for post-surgical ocular inflammation of pain, initiating two Phase 3 clinical trials for DEXTENZA for the treatment of allergic conjunctivitis completing patient enrollment and reporting top-line efficacy data, completing patient enrollment in our Phase 2 exploratory clinical trial of DEXTENZA for the treatment of inflammatory dry eye disease and reporting top-line efficacy data, completing the patient enrollment in our ongoing Phase 2 b clinical trial of OTX-TP for the treatment of Glaucoma in ocular hypertension and reporting top-line efficacy data and then initiating Phase 3 clinical trials for that program. And finally, advancing our sustained-release hydrogel depot clinical program – pre-clinical program for the intravitreal delivery of anti-VEGF drugs for the treatment of Wet AMD. For the first quarter ended March 31, 2015, we reported a net loss $7.6 million, or a loss of $0.35 per share, this compares to a net loss of $7.0 million, or a loss of $2.45 per share, for the first quarter of 2014. The net loss for the first quarter of 2015 included $900,000 in non-cash charges for stock-based compensation compared to…

Operator

Operator

[Operator Instructions] Our first question comes from Ken Cacciatore with Cowen and Company. Your line is open

Ken Cacciatore

Analyst · Cowen and Company. Your line is open

Great guys, thanks. A lot of progress. Thanks for the update. Just want to clarify a few things. You indicated a conditional acceptance of the NDA. Can you please clarify what that exactly means and again, a little bit more on the timelines that finish the next study? And then, also on your commentary around the TP program, you indicated, the last generation products were seeing 92% retention. Can you talk about how much more progress or if you are continuing to make any modifications of these most recent generation programs? And then maybe historically help us that with the NSR study correlation to what you’ve seen when you’ve actually gone into kind of broader clinical programs? Thanks a lot.

Eric Ankerud

Analyst · Cowen and Company. Your line is open

In regard to the proprietary name DEXTENZA, we submitted an application to FDA and through the normal processing of the review, we received the response of conditional acceptance which is typical for that stage of the review. The name now is to be included in our NDA submission for the completion of the formal proprietary review name and ultimate approval.

Amar Sawhney

President and CEO

So this is for the name, not for the application.

Ken Cacciatore

Analyst · Cowen and Company. Your line is open

Got you, yes, okay, thank you that clarifies. Thanks.

Amar Sawhney

President and CEO

The application will be – the NDA will be submitted for the post-surgical pain indication in the coming few months. So when we come to the second – so with regards to the second question on the NSR studies and what we are saying with the plugs et cetera, I think, as we’ve always said that the NSR studies tend to lead the way in terms of plug design and optimization and the drug studies as they enroll slower and are more infrequent, take typically little bit longer, so they lag behind a generation or so in terms of the plug design. So, what we are working with in the – but the important point to note is that they do mimic each other quite a bit and that’s what we learned from the NSR studies is very applicable for the drug plug studies. So what we’ve been learning in summary is, trying to optimize the size of the plug, the stiffness of the plug, the ease of insertion, because these are a little bit larger plugs than the dexamethasone, the DEXTENZA plugs. So, some of those learnings come about and if we have to optimize the design, for example rounding off the tip to be able to allow for easier insertion or to look at a certain stiffness of the plugs for comfort and removal, because these are all the chronic use plugs that we want to be able to insert them and also they will not be fully absorbed by the time we come in for the second therapy, repeat therapies and stuff because you want to have some degree of overlap. So, they need to be removable. So those are the things that we are optimizing in the NSR study. The retention rates that we are seeing…

Ken Cacciatore

Analyst · Cowen and Company. Your line is open

Thanks very much.

Operator

Operator

[Operator Instructions] Our next question comes from Adnan Butt with RBC Capital Markets. Your line is open.

Adnan Butt

Analyst · RBC Capital Markets. Your line is open

Hey good morning and let me ask three questions here. First, on the DEXTENZA filing. Why not wait until you get data from the inflammation study and then file and would you hire a sales force with just a pain indication? Then on the anti-VEGF depot program, so from what I understood at ARVO, it showed that in-vitro at least biologics could be dosed much longer than four months. Is that correct? And what’s the optimal period there? And is the company working with any small molecules, the TKIs at this time or planning to work with any that you might think are a better fit than others? That’s it. Thanks.

Amar Sawhney

President and CEO

Great. Yes, so let me answer the first question first, which is the, why not wait for the indication. As we look at that the data that we have, we find that we have extremely strong and compelling data on the pain indication and we have all of the other information that is needed from the safety standpoint, from the preparedness for the NDA filing standpoint to move ahead and begin the review process and gain an initial label. Remember that our strategy all along has been that of expanding the label for DEXTENZA, getting an initial label and then expanding it. And that label expansion strategy will go in many different dimensions. There are various types of inflammation. Inflammation that leads to after surgery inflammation that may lead to dry eye, inflammation associated with allergic conjunctivitis. And there are other inflammation-oriented conditions like Uveitis et cetera also. So, our strategy all along has been, get an initial label and then continue to expand that label to cover as much of that $2.7 billion and inflammation market as possible. So this basically is consistent with that strategy of ours. People have fairly good sense to clinical community as to the efficacy of steroids. And we are going to be able to deliver the first and only one of its kind front of the eye controlled release one and done steroid for the market. And there is a strong receptivity to that. We will build upon that. We are not trying to rest on our laurels, we’ll build upon that. But I think it is important for us to get the product in the hands of the clinical community that is anxiously awaiting a product of this sort. Going back to the other question of anti-VEGF agents, we continue to collaborate…

Operator

Operator

Thank you.

Amar Sawhney

President and CEO

Other questions?

Operator

Operator

If there are no further questions, I will now turn the call back over to Amar Sawhney for closing remarks.

Amar Sawhney

President and CEO

Well, I wanted to thank everyone for taking the time to join us on the call today. I hope the information we have provided on our plan path forward for our DEXTENZA product candidate for the treatment of post-surgical ocular inflammation and pain was both helpful and encouraging as we continue to advance this program towards commercialization. We have a number of important value-creating milestones this year across five different clinical and pre-clinical programs. And I look forward to keeping you appraised as to our progress on each of these. I also want to thank our employees, advisors and Board Members who have been devoting their time, energy and passion to contribute to the Ocular Therapeutix's mission and vision. On behalf of the entire Ocular team, thank you for all your support. You may now disconnect.

Operator

Operator

Thank you ladies and gentlemen. That does conclude today's conference. You may all disconnect and everyone have a wonderful day.