Earnings Labs

Ocular Therapeutix, Inc. (OCUL)

Q3 2015 Earnings Call· Tue, Nov 10, 2015

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. And welcome to Ocular Therapeutix's Third 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 call over to Brad Smith, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Brad Smith

Chief Financial Officer

Thanks Andrew, good afternoon and thank you for joining on our third quarter call. This afternoon we issued a press release providing up update on the Company's product development programs and details of our financial results for the third quarter ended September 30, 2015. These can be accessed on the Investor portion of our Web site at investors.ocutx.com. Leading the call today will be Dr. Amar Sawhney, our President, Chief Executive Officer and Chairman, who will provide a summary of the key clinical trial data results that were reported recently including top line efficacy results of our first phase pre-trial for DEXTENZA for the treatment of allergic conjunctivitis and interim top line efficacy results from our Phase 2b clinical trial evaluating our OTX-TP product candidate for the treatment of glaucoma and ocular hypertension. Following Amar's remarks, I will provide an overview of the financial highlights for the third quarter of 2015 before opening the call up for questions. We are joined today by Eric Ankerud, our Executive Vice President of Clinical, Regulatory, and Quality and 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 10-Q and filed with the SEC, which was filed earlier this afternoon. 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 future point, 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 afternoon everyone and thank you joining us on our call today. For the past several months we’re highlighted by numerous clinical and corporate accomplishments. Our clinical programs successfully advanced with an NDA submission in September to the Food and Drug Administration for our lead product candidate, DEXTENZA for a post-surgical ocular pain indication. We reported top line efficacy results for our Phase 3, first phase 3 clinical trial for DEXTENZA for the treatment of allergic conjunctivitis and initial top line efficacy results from our Phase 2b clinical evaluating OTX-TP, our preservative pre sustained-release travoprost product candidate for the treatment of glaucoma and ocular hypertension. Lastly, we expanded and strengthened our Board of Directors with the appointments of two highly respected individuals. We welcome Dr. Jeffrey Heier, a prominent Retina Specialist at Ophthalmic Consultants of Boston and a leading retinal clinical researcher of new treatments for diseases of the back of the eye. And just yesterday we announced that James O’Shea, former Chief Operating Officer, President and Vice Chairman of Sepracor., has joined our Board bringing substantial experience in successfully managing commercial stage biotechnology companies. Jim led the successful launch of Lunesta and other products during his tenure at Sepracor. I look forward to their valuable insights that they will contribute to our Board. With several key data releases during the past several months let me review our objectives for our clinical study since Phase 2 results for our sustained delivery approach cannot be interpreted in the exact manner as a traditional biotechnology companies results which are frequently setup as dose escalation studies powered to report on defined primary and secondary end points. Since we already use drugs with known mechanism of action and known efficacy, our Phase II clinical trials are set up to evaluate appropriate…

Brad Smith

Chief Financial Officer

Thanks, Amar. With regard to our cash and investment position, as of September 30th, 2015, we had a 113.6 million in cash, cash equivalents and marketable securities. Cash use and operating activities was 9.7 million in the third quarter of 2015, it was 25.1 million year-to-date through September. We expect cash use in operations to be in a range of 36 million to 37 million for the full-year 2015 and expect capital expenditures to be in a 3 million to 4 million range for the year. Furthermore, we expect existing cash and investments to fund the company's operating activities, capital expenditures and debt service through at least the third quarter of 2017. And at the end of September, we had 15 million in outstanding debt. The third quarter ended September 2015, we reported a net loss of a 11.5 million or a loss of $0.47 per share. This compares to a net loss of 7.3 million or a loss of $0.48 per share for the third quarter of 2014. The net loss for the third quarter of 2015 included 1.2 million a non-cash charges for stock based compensation, compared to 600,000 in similar charges for this comparable quarter in 2014. Revenues for the third quarter of 2015 totaled $400,000 including revenue from the sales of our ReSure Sealant and collaboration revenue. As previously stated, we don’t expect product revenues from the sales of ReSure to be material in 2016 as we are differing the hiring of a direct salesforce until we launch our initial sustain release drug delivery product. Total operating expenses during the third quarter 2015 were a 11.6 million which compares to 6.9 million for the third quarter of 2014. We increase our investment in R&D in the third quarter of 2015 as we advanced OTX-TP for the treatment of glaucoma and ocular hypertension through the Phase 2b clinical trial against DEXTENZA for the treatment of allergic conjunctivitis through the first Phase 3 clinical trial and advanced our exploratory Phase 2 clinical trial at DEXTENZA for the treatment of inflammatory dry eye disease. We also made investments in our preclinical programs for the treatment of wet AMD and other back-of-the-eye diseases. Research & Development expenses totaled 8.3 million in the third quarter of 2015, compared to 4.5 million in the third quarter of 2014. At the end of September, we had approximately 24.7 million shares outstanding. This concludes my comments on the third quarter 2015 financial results. We will now turn it back over to Andrew for Q&A. Operator?

Operator

Operator

[Operator Instructions] And our first question or comment comes from the line of Ken Cacciatore with Cowen and Company. Your line is now open.

Ken Cacciatore

Analyst · Cowen and Company. Your line is now open

Hey, guys. Thanks for the additional details as you did more analysis. Can you just flush out a little bit more for us the decision from the 75 to the 90 days? I think just the explanation was that even though it may not have appeared that it was being retained that you think that the plug was. Can you just talk about kind of what you’re seeing in IOP lowering in those patients that the drug doesn’t seem right, the plug doesn’t seem retained but you were still seeing fairly decent IOP lowering. Is that these kind of the real simple explanation?

Brad Smith

Chief Financial Officer

Two things, Ken. Thank you for the question. I think that we had even at the time that we announced the results earlier, we had seen the IOP lowering at 90 days was consistent and good compared to other time points, so meeting that five kind of unit threshold. The thing that we learned with the additional analysis was that when we looked at this post-hoc analysis where we took away some of the patients who were about 10% of the patients who were on more than one medication for IOP lowering.0 And this is when you start out looking at the inclusion criteria you want to start out broad in Phase 2 and then narrow it to a Phase 3. So, we took all comers up to two drops of IOP lowering drops. So, but however you think about why somebody would be on the second drop relative to having a first drop of prostaglandin is because there would be under responders to prostaglandin. And since our drug is a prostaglandin, to some extent that is probably not the right population to include. So we looked at the cohort where these 10 patients were excluded and what we found was that the gap narrowed a fair amount between us and Timolol. So, that gave us that 0.7'ish units that we would have gotten by say moving the product from a 90 day to a 75 day product by maybe having a little bit more drug being released. So, we don’t really feel that that is required and given that by an exclusion criteria modification which is relatively simple to do and really wouldn’t affect the enrolment all that much or the population that is addressable by this product all that much. We would be able to attain that differential that we were looking for. So that was the rationale behind saying I think this product has been seen to lower IOP out to 90 days and if you look at the patient population of patients on one drop, you should be able to get closer to the Timolol differential.

Ken Cacciatore

Analyst · Cowen and Company. Your line is now open

Okay.

Brad Smith

Chief Financial Officer

Now, ideally we would like to see a little bit more differential narrowing and that’s what we would like to evaluate the role of the placebo plug in the Timolol arm.

Ken Cacciatore

Analyst · Cowen and Company. Your line is now open

Okay. And then, you’re talking about working on a placebo plug or a plug that maybe I would think dissolves more rapidly or maybe is not as tightly fitting on the placebo yet still kind of mask the placebo. Is there still a chance that you may run a straight placebo arm that has no Timolol component on it, just a plug with no Timolol or is that out of the question, is that still up for debate as you go to FDA?

Brad Smith

Chief Financial Officer

So, if I understand your question correctly, the question is would you consider having a placebo only arm and do a kind of a comparison to a placebo group?

Ken Cacciatore

Analyst · Cowen and Company. Your line is now open

Yes.

Brad Smith

Chief Financial Officer

Is that what you’re asking?

Ken Cacciatore

Analyst · Cowen and Company. Your line is now open

Yes.

Brad Smith

Chief Financial Officer

So, and we are ruling out any options. Certainly that is one of the options, but it’s not the preferred option from our standpoint. Our preferred options would be to look at more of a real world situation where we are directly comparing our depot to Timolol drops the way they are used in the real world or there are some additional clinical study designs that I don’t want to speculate on at this point in time that may involve a different type of analysis. Since we have to have some conversations with the agency, I wouldn’t speculate on that, but the comparison to placebo while theoretically is a possibility, is a less preferred option because enrolment of such studies can prove to be difficult. We like to enroll our studies robustly as we just are demonstrating with our Phase 3 on in pain and inflammation that is ongoing. We would think that with patients are not put on a particular therapy for extended periods of time it may be harder to enroll that study. So, while we’re not taking it off the table, it is a less preferred option.

Ken Cacciatore

Analyst · Cowen and Company. Your line is now open

Great thank you.

Operator

Operator

And our next question or comment comes from the line of Andrew Baron with Morgan Stanley. Your line is now open.

Andrew Baron

Analyst · Morgan Stanley. Your line is now open

Hi, thanks for taking the question, guys. One of the concerns that we had, I think was the amount of drop used for with TP was less than what you would normally see with Timolol just based on the amount in other clinical trials, not your trial per se. So I am just trying to understand one of the things I thought you are going to try to do is get more drugs into the plug. This new 90 day plug, the reformulation which is former and has a higher retention rate. Is there a possibility that you can get more drugs into that plug?

Amar Sawhney

President and CEO

So Andy I don’t think now we had speculated that we wouldn’t necessarily expect to see much higher. We would – when we talked about the 75 day plug we talked about being able to put maybe a 10-15% more drug into it to be able to get a slightly more enhanced effect. Our feeling is right now that that trade-off is probably not required given that we can get that differential simply by our inclusion criteria adjustment wherein if the under responders to prostaglandins are taken out the you would probably be able to achieve that differential narrowing. So that’s not required. Now there is an additional portion to be understood in the double dummy design when we conducted this prior study we used a double dummy design which not only involves putting up placebo plug thus bolstering the effect of the Timolol drop and also involves administering placebo drops to the OTX-TP patients thus washing out the prostaglandin analog that is eluting out slowly. So by, we again think that this doesn’t necessarily reflect real world type of situations so if we can come up with a clinical study design that eliminates both these double dummies and still is able to mask the evaluator. Then you should be able to theoretically not allow Timolol to have such a high effect and potentially by not washing the drug out in the OTX-TP arm maybe the effect is enhanced. So these are some things that would be nice to study in some short-term type of one month type of studies. If that effect is seen then that gives us guidance and more confidence that this differential will be under control.

Andrew Baron

Analyst · Morgan Stanley. Your line is now open

What do you think if you design a trial that were would you expect that a label of the FDA or grant would exclude Timolol, I mean not prostaglandins hyper responders and if so what portion of the patient population does that represent?

Amar Sawhney

President and CEO

So we are not talking about Prostaglandin hyper responder, we’re talking about removing under responders 10% of that population was observed to be there in our current clinical trials so we don’t think that this is a large population. It is basically 10% of patients in the first line of administration of prostaglandin maybe on more than one drop. So we would be only be potentially about 10% of the population.

Andrew Baron

Analyst · Morgan Stanley. Your line is now open

Okay. Thanks I appreciate the color.

Operator

Operator

And our next question or comment comes from the line of Adnan Butt with RBC Capital Markets. Your line is now open.

Unidentified Analyst

Analyst · RBC Capital Markets. Your line is now open

Hi guys this is for Arshad Haider here for Adnan. Thanks for the question on OTX-TP can you elaborate on some of the work that needs to be done before starting the phase 3?

Amar Sawhney

President and CEO

Yes so the work that may need to be done primarily consists of being able to have a discussion with the FTA on the clinical study design options. So we are asking for a meeting to be able to discuss two or three of the clinical study design options that we have on the table with them. Some of the other work we are going to be incorporating the learning from our non significant risk studies such as adding a particular shape dissolving tip to the plugs so that they can be easier to insert so that is work that has already been completed so it’s not – but remains to be done, but will be just be a feature that is incorporated into it. .:

Amar Sawhney

President and CEO

Okay thank you.

Operator

Operator

[Operator Instructions] And our next question or comment comes from the line of Hartaj Singh with BTIG. Your line is now open.

Hartaj Singh

Analyst · BTIG. Your line is now open

Thanks for the question. Just had a couple. As you’re going forward at the end of this year. Next year around this time you’ll have another approved product DEXTENZA assuming FDA approval of a post surgical pain is a good chance that you’ll also be getting ready or might not or might already have submitted an sNDA for inflammation and then maybe even the allergic conjunctivitis. What are some of the things can you just kind of walk us through on a higher level strategically speaking and then operationally, the thing that you’re doing over the next 6 to 12 months kind of prepare the company to stay also still a research and development organization but also have to prove products with three maybe even four different labels and indications? Thank you.

Amar Sawhney

President and CEO

Sure that’s an excellent question. So obviously we need to start maturing as an organization in both operationally as well as commercially to be able to stand and readiness to begin initial commercialization towards the end of 2016 and then prepare for full commercial launch in 2017. So there are several activities that are underway in that regard some of these for example are in building up manufacturing capacity, preparing for the FDA audits that would be happening. So readying the quality organization for that expanding the manufacturing capacity in organization, some automation might be introduced. There are those types of things that we’re doing on the operational side. On the commercial side as you saw we just added Jim O’Shea as Board Member who has an extensive commercialization history and within the organization we’ve also just hired our first medical director to start bolstering some of the activities and outreach to clinicians. We’re starting to add to the commercial organization and we will adding some folks on the head of sales for example as well as starting to talk to a number of contractor sales organizations and picking one to be able to provide us with the contract sales force that would be needed. So several steps need to be taken and are being taken also on the reimbursement side of things in readiness for getting pass through payment initially and getting eventually a [j-core] for allergic conjunctivitis. So, it is important that the product DEXTENZA has a payment mechanism both for use and surgery as well as in office and the allergic conjunctivitis indication would obviously be a office based indication while the post surgical indications are surgery based indications. So, putting payment mechanisms in place for that and having appropriately imbursement strategies in place is also something that we’re actively working towards.

Hartaj Singh

Analyst · BTIG. Your line is now open

Got them all. And then , just one follow up to that is there, do you kind of, I know this might be thinking too far ahead but in 2016 do you kind of foresee maybe a kind of analysis briefing on the commercial opportunities for 2, 3, 4 products and just kind of walking through people what for example the office space indications, what it’s like, what are the doctors, kind of how you could see reimbursements are rolling out or something like that or would you well rather wait to get a approval before doing something like that?

Amar Sawhney

President and CEO

Well, the progress on the NDA with the FDA seems to be quite rapid, they have been very communicative and we’ve had lot of back and forth with them. So, we’re feeling that seems to be progressing so we might have an Analyst Day in Q1 of next year where we sit down and review both the commercial opportunities of the product that we’re currently developing as well as take a deeper look at other things that might be there in the pipeline that we currently are working on and at the clinical stage that we haven’t discussed. We will talk about.

Hartaj Singh

Analyst · BTIG. Your line is now open

Great, thank you, looking forward to it.

Operator

Operator

And at this time I’m showing no further questions, so with that said, I would like to turn the call back over to CEO, President and Chairman, Dr. Amar Sawhney for closing remarks.