Earnings Labs

Ocular Therapeutix, Inc. (OCUL)

Q3 2019 Earnings Call· Tue, Nov 12, 2019

$9.09

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to the Ocular Therapeutix's Third Quarter 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 Donald Notman, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Donald Notman

Chief Financial Officer

Thank you, Daniel. Good afternoon, everyone, and thank you for joining us on our third quarter 2019 financial results and business update conference call. This morning, before the open, we issued a press release providing an update on the company’s product development programs and details of the company’s financial results for the quarter ended, September 30, 2019. The press release can be accessed on the Investors portion of our website at investors.ocutx.com.Leading the call today will be Antony Mattessich, our President and Chief Executive Officer, who provide a summary of our corporate developments and an update on the DEXTENZA commercial launch. Also speaking on the call today will be Dr. Michael Goldstein, our Chief Medical Officer, who will give an update on our clinical developments and pipeline. Following Michael’s remarks, I will provide an overview of the financial highlights for the third quarter 2019 before turning the call back to Antony for a summary and questions. For Q&A, we will also be joined by Scott Corning, our Senior Vice President, Commercial.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 the most recent Quarterly Report on Form 10-Q, which was filed with the SEC this morning November 12, 2019.In addition, any forward-looking statements represents our view 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, except as we are required to do so by law even if our views change.I will now turn the call over to Antony.

Antony Mattessich

President

Thanks, Donald, and thank you everyone for joining the call today for an update on the events of the quarter, including an update on the company, commercial launch of DEXTENZA, and our pipeline. The launch of DEXTENZA remains the company key focus. For those of you who may be new to the Ocular story, DEXTENZA is a bioresorbable, intracanalicular insert that delivers a 0.4 milligram tapering dose of preservative-free dexamethasone for up to 30 days.DEXTENZA is approved for the treatment of ocular inflammation and pain following ophthalmic surgery. The product is the first of a novel dosage form in route of administration, that has the potential to become a transformative product for both patients and physicians. For patients, DEXTENZA offers the convenience of a full course of steroid treatment and single preservative-free insert and for surgeons it puts control of the post-surgical steroid regimen back in their hands by mitigating against the risk of patient noncompliance.We started the commercial phase of our DEXTENZA launch in July of this year after securing price [ph] of CMS achieving full reimbursement in Medicare patients in a hospital and ASC settings and securing a temporary C-code billable in the surgical setting. We are very pleased with our progress. We are in the early stages as we continue to build the necessary elements to achieve a successful product launch.In a hugely important setup of DEXTENZA's early uptake as well for its long term potential on October 01, CMS issued a permanent product specific J-Code for DEXTENZA. The J-Code replaces the temporary C-Code. Compared to the C-Code a J-Code is easier and more familiar to billers and payers, so it can facilitate the broadening of coverage and accelerate immediate uptake, but and most importantly for DEXTENZA it allows for the billing across all sites of service…

Michael Goldstein

Management

Hello everyone.

Antony Mattessich

President

Before handing over to Mike, I want to say a few words about what we are doing to ensure that we have adequate capital to realize Ocular's potential. As was disclosed a few days ago, I have completed a reallocation of our personnel that has resulted in an increase in our promotional capability of 50%, but has reduced our overall expense spend [ph] by an estimated $11 million per year and another $14 million in one-time savings in deferred program costs. We expect the effect of our reallocation of resources to extend our runway to the fourth quarter of 2020.It is important to note that the forecast in forming this runway expectation does not include any contribution from further infusions of capital into the company. It also preserves our ability to drive our current Phase 1 programs through to completion, add another IND into our pipeline and execute on our lifecycle plan for DEXTENZA.Without further ado, I'll hand over to Mike.

Michael Goldstein

Management

Thanks Antony. DEXTENZA represents a franchise opportunity for the company. Physician and patient enthusiasm for the product has been high. We believe DEXTENZA represents a better way to deliver medication to the eye compared with traditional eye drops. We are actively dosing patients in our Phase 3 clinical trial of DEXTENZA in the treatment of ocular itching associated with allergic conjunctivitis. The current study is a multicenter, one-to-one, randomized, double-masked, placebo controlled Phase 3 clinical trial that intends to enroll approximately 50 [ph] subjects.The study's primary objective is to evaluate the safety and efficacy of DEXTENZA versus a placebo vehicle insert using the modified conjunctiva allergen challenge model for the treatment of ocular itching associated with allergic conjunctivitis. The trial is designed to assess the effect of DEXTENZA compared to placebo and allergic responses using a series of successive allergen challenges over a 30-day period. The primary efficacy endpoint being evaluated in this study is ocular itching following insertion of DEXTENZA at multiple time points during the 30-day period.The allergic conjunctivitis trial tends to enroll relatively quickly at despite just dosing the first patient in October, we anticipate data from this trial in the first half of 2020. If successful, this trial will be part of our FDA submission to expand the potential indication of DEXTENZA for the treatment of allergic conjunctivitis which would be its first indication not associated with surgery. DEXTENZA in allergic conjunctivitis offers a novel way of delivering drug to the surface and anterior segment of the eye in a way that we believe can improve upon the existing standard of care eye drop treatment regimen.Overall, we are thrilled with the interest we are receiving from the ophthalmic and optometric communities and requesting permission to start or actively conduct investigator initiated trials around DEXTENZA. The interest…

Donald Notman

Chief Financial Officer

Thanks, Michel. Net revenues for the third quarter totaled $0.8 million in aggregate consisting of $0.3 million and $0.5 million in net revenues from DEXTENZA and ReSure respectively as compared to $0.5 million in net revenues generated in the third quarter of 2018, all of which were related to ReSure.Research and development expenses for the third quarter were $10.2 million versus $9.7 million for the comparable period in 2018, and reflecting increasing costs associated with the Phase 1 OTX-TIC trial, the Phase 1 OTX-TKI trial and the start of the Phase 3 DEXTENZA allergic conjunctivitis trial, as well as the increases on unallocated costs. These were offset by a significant reduction in Phase 3 clinical trial costs associated with OTX-TP.Selling and marketing expenses for the third quarter were $6.8 million. This compared to $1.1 million for the same quarter in 2018. This increase relates almost entirely to support the commercial launch of DEXTENZA driven primarily by the hiring of new members of the commercial team in the second quarter of 2019, including KAMs, FRMs, and MSLs, as well as increased spending on consulting, trade shows, conferences and related costs.Finally, general and administrative expenses were $6.2 million for the third quarter versus $4.4 million in the comparable quarter of 2018. The increase in expenses for the third quarter stemmed primarily from increased personnel and facilities costs, offset by decreased professional fees.With respect to financial results for the third quarter, we reported a net loss of $18.9 million or a loss of $0.40 per share on a basic and $0.45 per share on a diluted basis. This compares to net loss of $15 million or a loss of $0.38 per share of basic and diluted basis for the same period in 2018. And net loss for the third quarter included $3.9 million…

Antony Mattessich

President

Thanks, Donald. So before opening the call up for questions, let me do a quick summary. We're working through the complexities of pull through for buy-and-bill product in the upcoming surgical setting, we are pleased with the DEXTENZA launch in terms of in market sales acceleration and reordering patterns.The performance has given us confidence to expand our field force by 50%. We are anticipating a long lifecycle for DEXTENZA with the issuance of our unique J-Code and the initiation of potentially our final pivotal trial for a label expansion into allergic conjunctivitis.In our glaucoma program, the intracanalicular OTX-TIC, we now have efficacy beyond 16 months with a single insert and have made the decision to begin dosing our third patient cohort in our Phase 1 trial. Our back of the eye program has continue to progress with OTX-TKI and the dosing of the second cohort in its Phase 1 trial.Lastly, we have successfully completed restructuring program that's designed to focus our efforts on maximizing the commercial opportunity of DEXTENZA and on advancing our high priority pipeline initiatives. These efforts will save an estimated $11 million annually and approximately $14 million in one-time program deferments that extend the Company's current cash runway through the fourth quarter of 2020.With that, I will turn the call over for questions.

Operator

Operator

[Operator Instructions] Our first question comes from Yi Chen with H.C. Wainwright. Your line is open.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is open

Hi, this is [indiscernible] in for Yi Chen and thanks for taking my question. So I just wanted to talk a little bit about the ambulatory surgical centers that have adopted DEXTENZA. So can you please tell how many of these centers are we talking about? And how many do you expect to achieve by the end of 2019?

Antony Mattessich

President

Yes, thanks for the question. Well, we're not going to disclose at the moment what the number of centers are. We have a - we're confident that the number that if we penetrate the centers that we have that we'll be able to reach the sort of internal figures that we have for DEXTENZA that we hope for the sales line.We're also adding at a very high rate. As we mentioned, just the sales acceleration in October, we sold more in October than we did in the entire launch period before, for the whole quarter before, that we are adding them quickly and as we start to expand with a new field force, we'll be able to reach centers that we haven't as of today. So it is, we expect a big expansion in that number. We'll start reporting that number on a regular basis as we go forward, but right now, we're going to sort of keep that to ourselves for a bit.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is open

All right, understood. So the next one, do you plan to report the end use of demand for DEXTENZA in terms of units per quarter going forward?

Antony Mattessich

President

We haven't decided what metrics we're going to report going forward. Clearly, once we get into a steady-state, where we start to have the end market and the to-market numbers start to sort of move with each other, the to-market sales will be pretty descriptive about what's happening in the marketplace.So we will sort of agree on what a set of metrics are that we'll be presenting on regularly going forward, but clearly, as the product ramps up that to-market number, we'll be your best indicator of the performance of the product.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is open

Okay. And then a little bit on investigator initiated trials. Maybe you can provide us or elaborate our bird's eye view on this and how many centers are we talking about and what are your expected outcomes from this investigator initiated trials?

Antony Mattessich

President

Sure, I'll hand it over to Mike Goldstein, to talk about the IITs, Mike?

Michael Goldstein

Management

Yes, thanks for the question. As mentioned, there is widespread interest within both the ophthalmic and the optometric community on investigator initiated trials. We are looking at a whole range of different proposals covering multiple different non-cataract surgeries as well as different timing around using the inserts for cataract surgery.And so at this point, we are executing on some of those proposals and evaluating others and really on a daily basis continue to get new thoughts and ideas. So I think for us, what's really exciting is, there's this widespread interest in both the ophthalmic and optometric communities to be able to use this product in a myriad of different ways.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is open

Okay, great. And one final question from me with regards to OTX-TKI. So how many dosages do you plan to test overall?

Antony Mattessich

President

Mike, why don't you keep coming?

Michael Goldstein

Management

Yes, sure. Thanks for the question. So for - the design is to test two different doses. And then to take the maximally tolerated dose forward and do a combination study in a combination arm along with an antidrug.

Unidentified Analyst

Analyst · H.C. Wainwright. Your line is open

Okay, that's it from me. Thank you so much.

Antony Mattessich

President

Thank you.

Operator

Operator

Thank you. [Operator Instructions] Our next question comes from Joe Catanzaro with Piper Jaffray. Your line is now open.

Joe Catanzaro

Analyst · Piper Jaffray. Your line is now open

Hey, guys, thanks for taking the question. So, on the 2Q call you mentioned that about 3,000 patients have been treated with DEXTENZA and that number is now up to 7,000. But it sounds like there's still a high level of sampling ongoing. So maybe you could just help us understand or tell us the percent or your hit rate in terms of the number of centers that have participated in DEXTENZA? And then subsequently placed initial order and what's that timeframe from sampling to placing an initial order?

Antony Mattessich

President

Well, it's hard to sort of put out an actual sort of number on what the difference between the DEXTENZA a day and the ASC order because it's so variable. One thing I can confirm is that we now sell more products than we have samples. So those lines have crossed, which is about the period where we expected them to cross.So it's going forward clearly our sample numbers are coming down fast and our sales are going up strongly, so we're kind of where we thought we would be at this point. One of the key points about why we sort of entered the market the way we did with a very tight field for us, so we have only 20 key account managers, was really to determine the kind of lags the product had and the uptake patterns that we would see with a key account manager in place.Now we've seen that and we are confident enough from the cycle time that we're seeing to add our field force by another 50% or another 10 KAMs. So that cycle time and the type of ASC and type of hospital that we see we can target that has faster turnaround times we understand now and have the ability to as we enter new territories to shorten what that cycle time is, but clearly getting that first order is the hardest bit.

Joe Catanzaro

Analyst · Piper Jaffray. Your line is now open

Okay, got it and then, so what are you hearing from centers that maybe have placed an initial commercial order, but having subsequently reordered, what are some reasons why that hasn't happened?

Antony Mattessich

President

Well, the main reason and pretty much the only reason we hear that they're waiting to see the reimbursement. So as we mentioned, we have the centers that have ordered 50% have reordered. That doesn't mean that only 50% are going to reorder. We were adding new centers very, very quickly with initial orders and essentially we are expecting virtually all of the centers that have ordered once to order again. But as part of their process, many of them will wait to see a positive reimbursement from a number of patients before they order for a second time.So initial orders, may be one or two inserts. They'll put them in a patient and then they'll submit and then they'll wait for reimbursement. Now provided they've sent out the forms correctly and provided the max are comfortable with the submission, the payment comes relatively quickly usually within three weeks.If there's something wrong on that form or there is some glitch in the in the approval, and clearly all of these will be approved if they're used in the right patient, then that gets delayed. So that that's really -- it's a really a time issue about the reordering. We simply don't have -- we don't expect any of the centers that have ordered not to reorder because we haven't heard anything from these centers saying that they are not interested in continuing with the product.

Joe Catanzaro

Analyst · Piper Jaffray. Your line is now open

Okay, got it. Thanks for taking my questions.

Antony Mattessich

President

Thanks Joe.

Operator

Operator

Thank you. I'm not showing any further questions at this time. I'll now turn the call back over to the CEO, Antony Mattessich for closing remarks.

Antony Mattessich

President

I'd just like to thank everybody for attending the call today and we look forward to a very bright future.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. You may now disconnect.