Ocular Therapeutix Inc (OCUL) 2021 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix First Quarter 2021 Earnings Conference Call. (Operator Instructions)

It is now my pleasure to turn the call over to Donald Notman, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and thank you for joining us on our first quarter 2021 financial results and business update conference call. This afternoon after the close, 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 March 31, 2021. 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 will provide a summary of our corporate development and an update on the commercial progress of DEXTENZA. Also speaking on the call today will be Dr. Michael Goldstein, our President, Ophthalmology and 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 first quarter, before turning the call back over to Antony for a summary and questions.

For Q&A, we will be joined by Scott Corning, our Senior Vice President, Commercial; and Chris White, our Senior Vice President, Business and Corporate Development.

As a reminder, on today's call, certain statements we will be making may be considered forward-looking for the purposes of the Private Securities Litigation Reform Act of 1995. In particular, any statements regarding our regulatory and product development plans as well as our research activities are forward-looking statements. These statements are subject to a variety of risks and uncertainties that may cause actual results to differ from those forecasted, including those risks described in our most recent quarterly report on Form 10-Q filed this afternoon with the SEC.

I will now turn the call over to Antony.

Thank you, Donald. And welcome everyone to Ocular Therapeutix first quarter 2021 earnings report. It's been a good start to the year and we are pleased with our progress in the first quarter, both on the commercial front as well as with advances in our pipeline of product candidates being developed to target several of the largest market opportunities in ophthalmology. Overall, total net product revenue for the quarter was $7.3 million.

Beginning with DEXTENZA, we achieved $6.7 million in net sales to our distributors for the first quarter. While the net sales growth over the previous quarter is essentially flat, the picture in market billable sales unit shows more clearly the development of DEXTENZA sales, primarily because it isn't obscured by variations in distributor inventory levels.

For the first quarter of this year, we achieved a record quarter for in-market sales in billable units of 16,634, representing nearly 15% sequential quarterly growth. While billable units were just over 4,500 and 4,900 in January and February, respectively, March billable units grew strongly to over 7,000 units, our highest monthly total to date. We believe March sales reflect both reopenings and higher capacity utilization of ASCs and HOPDs.

I'm also pleased to report that the March momentum has continued into April. Sales of billable units to end customers in April are expected to exceed 8,000 units and comfortably set a new monthly record. This is especially gratifying in that April is the first month of a new quarter when in-market sales are typically slow to build up. We believe that this recent acceleration of in-market demand reflects a continued growth in our share of total cataract volume and also return to more normal levels of cataract surgeries being performed across the U.S. We expect these drivers to continue to [propel] growth throughout the year.

It is important to note that in our last quarterly earnings call, we indicated that we would no longer report on monthly in-market sales of billable units after the first quarter of this year and that we would restrict our disclosures to quarterly net sales to our specialty distributors. However, for the changing market conditions that we experienced in the first quarter due to COVID-19, the continuing adjustments of inventory management by our distributors and the maturing of our gross-to-net calculations, we believe that it makes sense to continue to provide monthly in-market sales in billable units at least through the second quarter of 2021.

Moving to our pipeline, we have 4 clinical programs, each of which is geared to produce a highly differentiated ophthalmology specialty product that addresses the key unmet need in its respected disease state. In the aggregate, the target disease states are estimated at over $20 billion in annual global sales. We believe our pipeline remains a source of tremendous value for Ocular, and we are adequately capitalized to fund each of our 4 clinical programs through key Phase II clinical trials, which we believe could mark an inflection point for us. This week, we have 6 company presentations and one presentation from an IIT at the 2021 Association for Research in Vision and Ophthalmology, or ARVO, virtual meeting.

To highlight a few of the key presentations, we presented updates to interim analysis of Phase I data for both OTX-TKI, our intravitreal bioresorbable hydrogel-based implant for the treatment of wet age-related macular degeneration and other retinal diseases. And OTX-TIC, our intracameral travoprost hydrogel-based implant for the reduction of interocular pressure in patients with primary open-angle glaucoma or ocular hypertension. Both presentations provide updated data that are consistent with the development of potential products that could become the standard of care in these large markets.

We are also presenting preclinical data for our product starting ocular surface disease. We have posters presenting preclinical PK data of OTX-CSI, our cyclosporine containing intracanalicular insert to increase tear production in patients suffering from dry eye disease, and the OTX-DED, our dexamethasone containing intracanalicular insert, the short-term treatment of signs and symptoms of dry eye disease. Additionally, later this week at ARVO, we will be presenting data on DEXTENZA for the treatment of allergic conjunctivitis. As many of you may know, we have submitted a supplemental new drug application to the FDA for the use of DEXTENZA and allergic conjunctivitis, and have received a PDUFA target action date of October 18 of this year. And this presentation evaluates the safety of the product candidate in a pooled post-talk analysis of the 4 clinical trials included in our regulatory filings.

I encourage you to take a look at these presentations, which can be accessed either at the ARVO website or on our corporate investor page. Overall, I am pleased with the year on all fronts and I'm confident for another productive year.

With that, I would now like to hand over the call to our President of Ophthalmology and Chief Medical Officer, Dr. Michael Goldstein, who will provide an in-depth look at our pipeline.

Thanks, Antony. Let me begin with an update on our back-of-the-eye program, OTX-TKI. We continue to test subjects in a multicenter open-label dose-escalation Phase I clinical trial, being conducted in Australia that is designed to assess the safety, durability and tolerability of OTX-TKI as well as to assess preliminary biological activity in subjects by measuring anatomical and functional changes. As Antony mentioned, we presented incremental interim data at ARVO. This update highlights data from the first 3 fully enrolled cohorts. Cohort 1, 200 micrograms; cohort 2, 400 micrograms; and cohort 3a, 600 micrograms as well as from cohort 3b, 400 micrograms OTX-TKI used in combination with anti-VEGF induction therapy, which is currently enrolling.

We continue to see signals of biological activity, including decreases in retinal fluid in some subjects as early as 2 months following insertion in cohorts 2 and 3a. Additionally, we are seeing encouraging durability of 6 months or longer in all cohorts and durability out to 13.5 months in one subject in cohort 2 and 9 months in one subject in cohort 3a. OTX-TKI has generally been well tolerated and has been observed to have a favorable safety profile.

No ocular serious adverse events, including subjects with elevated intraocular pressure and subjects needing steroids to treat ocular inflammation, have been observed or reported to date. While the drug product profile is still emerging, we are pleased with the interim data and OTX-TK'Is potential to reduce intraretinal and/or subretinal fluid. In terms of next steps, we plan to initiate a clinical trial in the United States starting in the middle of the year, using a single 600-microgram OTX-TKI implant, along with anti-VEGF induction therapy.

Moving to our glaucoma program, OTX-TIC. This study is a Phase I prospective multicenter open-label clinical trial enrolling subjects in the United States with primary open-angle glaucoma or ocular hypertension to evaluate the safety, biological activity, durability and tolerability of OTX-TIC. All 4 cohorts have been fully enrolled, and interim data presented this week at ARVO generally showed a mean reduction in intraocular pressure or eye pressure from baseline of 7 to 11 millimeters of mercury that is comparable to current standard of care topical travoprost placed in the non-study eye. This data is consistent with the interim data we presented at the Glaucoma 360 Conference in January.

Onset of action is as early as 2 days after insertion. Interim results suggest the durability of response consistent with decreases in eye pressure for 6 to 9 months in many subjects in cohorts 1 and 2, with one subject's eye pressure controlled for over 21 months for the single implant. OTX-TIC has generally been well tolerated and has been observed to have a favorable safety profile to date. We have not seen the implant move and it has been observed to bioresorb in 5 to 7 months in cohorts 1 and 2 and 3 to 5 months in cohorts 3 and 4. We have seen no clinically meaningful changes in corneal pachymetry or corneal endothelial cell counts over time.

With the Phase I study now fully enrolled, our attention now turns to our planed Phase II clinical trial, which we now expect to initiate in the fourth quarter of 2021. This small delay in the start of the trial is the result of some additional optimization being done on the injector used to deliver the OTX-TIC implant.

We are also making significant progress with our ocular surface disease programs, which include product candidates for dry eye disease and allergic conjunctivitis. In dry eyes, we have 2 programs OTX-CSI, which is designed to increase tear production for the chronic treatment of patients with dry eye disease and OTX-DED, which is designed to target the short-term treatment of the signs and symptoms of dry eye disease. OTX-CSI is an intracanalicular insert, which combines 2 modalities to treat dry eye patients. Local programs released of cyclosporine for approximately 3 to 4 months to the ocular surface, along with punctal occlusion over the same time period.

By releasing low doses of preservative-free cyclosporine over to extended duration of time, OTX-CSI has the potential to minimize what we believe are some of the biggest patient complaints about commercially available products for the chronic treatment of dry eye disease, namely stinging and burning. We were very excited about the potential for this physician-administered hands-free and preservative-free option in helping dry eye patients receive the benefits of cyclosporine but with potentially greater tolerability and a more rapid onset of action compared to therapies currently available on the market.

We are pleased to announce that we have recently completed enrollment of our U.S.-based randomized masked Phase II multicenter clinical trial. This Phase II clinical trial is evaluating 2 different formulations of OTX-CSI compared with hydrogel vehicle insert in approximately 140 subjects will be followed for a period of 16 weeks. Endpoints in the study include tear production as measured by the Schirmer's test, signs of dry eye disease as measured by corneal fluorescein staining and symptoms of dry eye disease as measured by the Visual Analog Scale, or VAS, eye dryness severity score and eye dryness frequency score. As this trial is now fully enrolled consistent with our update last quarter, we expect top line data in the fourth quarter of 2021. Our second product candidate in dry eye OTX-DED is a low dose, intracanalicular insert a preservative-free dexamethasone.

While it incorporates the same active drug as DEXTENZA, this is a new product candidate with a lower dose of dexamethasone and a smaller insert size. Many dry eye patients experience episodic flares of their signs and symptoms, which we believe are likely related to inflammation. Topical steroids have long been used off-label for dry eye flares and all commercially available topical steroid eyedrops all have preservatives which can result in ocular surface toxicity. Chronic misuse of steroids may also lead to adverse events such as elevated high pressure or cataracts. OTX-DED potentially offers these patients the opportunity to be treated with a physician-administered preservative-free and hands-free steroid therapy that can't be overused by patients.

We are currently enrolling patients in a U.S.-based randomized double-masked vehicle-controlled Phase II multicenter clinical trial evaluating 2 different formulations of OTX-DED compared with a hydrogel vehicle insert in approximately 150 subjects with dry eye disease. The trial is designed to assess the safety and efficacy of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, the vast eye dryness frequency and severity scores and total corneal fluorescein staining.

And enrollment continues to move at a consistent pace and we expect top line data for the first half of 2022. Lastly, for DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis, we submitted an sNDA at the end of 2020 and have received a PDUFA target action date of October 18, 2021. Overall, we believe the data package highlights a compelling product profile targeting an unmet need that could potentially change the current standard of care with a physician-administered preservative-free hands-free therapy for these patients. This sNDA, if approved, would represent our first in-office indication for DEXTENZA.

I would now like to turn the call back over to Donald to review our first quarter financial results.

Thanks, Mike. Gross product revenue, net of discounts, rebates and returns, which the company refers to as total net product revenue, was $7.3 million for the 3 months ended March 31, 2021, representing a greater than 175% increase over the first quarter of 2020. Net product revenue of DEXTENZA in the first quarter was $6.7 million versus $2.1 million in the comparable quarter of 2020 and reflects an approximately 220% increase. Total net product revenue for the first quarter also includes net product revenue of $0.6 million from ReSure Sealant.

Research and development expenses for the first quarter were $10.9 million versus $6.1 million for the comparable period in 2020, primarily driven by increased head count as well as increased clinical trial costs associated with the ongoing Phase II clinical trial for OTX-CSI, the commencement of the Phase II clinical trial of OTX-DED and the ongoing Phase I clinical trials of OTX-TKI and OTX-TIC.

Selling and marketing expenses in the quarter were $8.1 million as compared to $7.1 million for the same quarter in 2020, reflecting increased personnel costs associated with the expansion of the sales force.

Finally, general and administrative expenses were $7.7 million for the first quarter versus $5.2 million in a comparable quarter of 2020. The increase in expenses stem primarily from increased personnel expenses and professional fees. With respect to the financial results for the first quarter, the company reported net income of $3.1 million or $0.04 per share on a basic basis and a net loss of $20.8 million or a loss of $0.24 per share on a diluted basis. This compares to a net loss of $21.5 million or a loss of $0.41 per share on a basic and diluted basis for the same period in 2020. As operating expenses increased quarter-over-quarter, modest profit was driven by noncash gain of $25 million related to the change in the fair value of the derivative liability associated with the company's convertible notes.

This change in fair value is due primarily to a decline in the company's common stock price during the quarter. Noncash charges for the stock-based compensation and depreciation and amortization was $3.7 million in the first quarter versus $2.4 million for the same quarter in 2020. As of May 3, 2021, the company had 76.2 million shares outstanding. As of March 31, 2021, the company had $209.4 million in cash and cash equivalents versus $228.1 million at December 31, 2020. Based on our current plans and related estimates of anticipated cash inflows from DEXTENZA and ReSure product sales and cash outflows from operating expenses, the company believes that existing cash and cash equivalent as of March 31, 2021, will enable the company to fund planned operating expenses, debt service obligations and capital expenditure requirements through 2023.

This cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, the revenues and expenses associated with the commercialization of DEXTENZA and the pace of research and clinical development programs and other aspects of the business.

This concludes my comments on our first quarter financial results, and I would like to turn the call back to Antony for some summary thoughts.

Thanks, Donald. So before opening the call up for questions, let me do a quick summary. We are pleased with continued progress in our pipeline and our growing presence at key medical meetings like ARVO that allow us to share our progress. In wet AMD, our Phase I trial continues to support OTX-TKI's differentiated product profile that could potentially set a new standard of care for durability. We remain on plan to initiate a U.S.-based Phase I clinical trial in the middle of 2021.

In glaucoma, data from our Phase I trial of OTX-TIC continues to support a durable, rapid onset product profile that could potentially set the standard of care for patient compliance. We plan to advance that program into a Phase II clinical trial in the fourth quarter of 2021.

In dry eye disease, we initiated 2 Phase II clinical trials, one for OTX-CSI and one for OTX-DED. For OTX-CSI, we now expect top line data in the fourth quarter of this year. For OTX-DED, we expect top line data in the first half of 2022. Beyond dry eye disease, we submitted our sNDA for DEXTENZA in allergic conjunctivitis in December 2020 and have a PDUFA target action date of October 18, 2021.

Finally, DEXTENZA achieved a record quarter for in-market billable sales units and is off to a very strong start in Q2. We look forward to a busy and productive 2021.

And with that, I will turn the call over for questions.

(Operator Instructions) Our first question comes from Joe Catanzaro with Piper Sandler.

Congrats on all the progress on all fronts here. Antony, I was wondering if you can elaborate a little bit more on the dynamics that drove the April DEXTENZA numbers that you're referencing and whether there are one-off events there. And relatedly are your expectations that May will grow off that 8,000 number followed by a bump in June with the rebate effect? And then, what should we expect in July, does it return back to that dynamic that you've observed historically?

Great. Well, thanks for the question. We expected the bump in March, we didn't expect to surpass March sales in April. That was a bit of a surprise to us. We have to remember that January and February were bad months. They were bad months for COVID and they were bad months for weather. So the return of what is somewhat normalcy for March was very much well expected, but typically, our pattern has been that the first 2 months of the new quarter are below the last month of the previous quarter. So whether this sets a new bar and we'll continue to grow off this level and expect to have the usual bump at the end of the quarter, it's hard to predict. But certainly, from anecdotal reports and from the field, it's really driven by the fact that surgery centers were back open, surgeons have been vaccinated, the administrators have been vaccinated, and more importantly, the patients have been vaccinated.

So our universe is essentially getting back to normal. And when you're gaining share in a growing market, it really can accelerate your sales. So I'm not going to sort of go on record and say where I expect to be next month and the month after, but I would still expect that sort of sawtooth kind of growth given the popularity of our rebate program.

Okay. Got it. That's helpful. And then maybe along this line of discussion, can you provide some details around the gross to net that you're seeing or saw in the quarter for DEXTENZA and maybe how much that fluctuates moving forward based on the extent of the rebate program usage?

Yes. There wasn't a great fluctuation in the gross to net. The fluctuation was really in the inventory at our 3PL. We finished last quarter around 30 days' worth of inventory. We finished this quarter about 22 days. So that was the lion's share of the difference that you see in the in-market versus the 2-market. Now there were some adjustments. Clearly, our rebate program is extremely popular. So it does have an effect, but the anomaly that you're seeing between 2-market sales and in-market sales is almost exclusively driven by that change in distributor holding.

Maybe if I could squeeze in one last one. As we think about the rebate program and surgical volumes seemingly picking up, is there more room for the rebate program to have even a bigger impact than what you saw over the last 2 or 3 quarters when that rebate program was put in place?

Absolutely. I mean you look at the size of the customers that we have, you look at an AMSURG or an ISOP partner, some of these really large consortia, we are just scratching the tip of the iceberg. So they are getting, of course, to the highest levels with the ASCs they have online. But the work at hand now is to get more of their ASCs participating. So we fully expect that, that rebate program will continue to drive volume, both in breadth, but I think more importantly, in depth.

Our next question comes from Jonathan Wolleben with JMP Securities.

Just a couple for me on the pipeline. You mentioned the new start for the OTX-TIC study due to some changes in the injector. I was hoping you could give us some more color in what you're trying to optimize for with these changes.

Jon, it's Mike speaking, thanks for the question. So we obviously want to optimize the patient and physician experience, and there are just some optimization work that needs to be done on the injector for the intracameral delivery. And that's caused a slight delay in the start of the Phase II program.

Okay. And then, with OTX-TKI, actually we're seeing progress in wet AMD, but you've had kind of DME and RVO list as potential opportunities. Wondering if you have any development plans in the works there or how you're thinking about the opportunities beyond wet AMD?

Yes. Great question. We do think there's big, big opportunities beyond wet AMD, and the 2 leading areas are DME and RVO. And we very much do have plans to pursue both of those opportunities in the future. We haven't announced exactly when those trials would start, but clearly, well within our plans.

Our next question comes from Georgi Yordanov with Cowen and Company.

Congratulations on the progress. So I do have a couple on the pipeline. It is clear for OTX-TKI that you have observed some striking responses during the study. Do you believe that there is a biomarker that could help you identify those patients that would respond to treatment before initiating treatment? And as a follow-up to that, have you considered exploring higher doses, given the excellent safety profile and that you have not reached a maximum tolerated dose? And then I do have a follow-up.

Yes. Two great questions. I think looking for biomarkers to look for responders is sort of the holy grail for not just us, but for many companies. So I would love to tell you we found what those biomarkers are to identify responders, but we have not -- but we will keep looking. And in terms of a higher dose, yes, we are interested in exploring a higher dose. We have shown an excellent safety profile stake up to 600 micrograms.

We are -- our immediate plans are to go forward with a single implant, 600-microgram dose, which, although it seems similar to the current dosing we have in Australia, that dosing is 3 200 microgram implants, that turns out that you do get a higher flux rate out of the implant per day when you go to a single implant. So there will be, if you will, a dose escalation there.

That said, we will continue to pursue the opportunity to look at higher doses. I think we're going to be limited not by tolerability, but really the ability to formulate in an implant that's of reasonable size. And so I think that will end up being what will prevent us from going too high, but we do have room to go higher than 600 micrograms.

Got it. And just related on TKI, we did notice that on the safety, you have indicated that in the most recent update there has been a moderate ocular AE. Have you disclosed the nature of that AE?

We have not.

And then, the last question is on the TIC program. So that's another very interesting program. You presented some pretty interesting early data. Could you remind us of the legacy OTX-TP glaucoma program and the issues there with development and what differentiates this clearly superior TIC product?

Yes. Great question. So both of the programs use the travoprost, which is a prostaglandin analog and very commonly used in clinical practice as an eye drop. The OTX-TP program delivered the prostaglandin through an intracanalicular delivery, and the OTX-TIC program delivers the travoprost through an intracameral delivery.

And clearly, when you go intracamerally, you get a higher dose of the drug to the target tissue, which is inside the eye. So as expected, we're seeing much higher levels of -- much higher ability to lower eye pressure with the OTX-TIC product over a longer period of time. So we're seeing approximately 7 to 11 millimeters of IOP lowering, and we've looked at 4 different formulations and we're seeing anywhere from 3 to 9 months of durability with a single implant.

So that's compared to the OTX-TP, the surface intracanalicular delivery, where it was more like between 2 and 4 millimeters of delivery for approximately 3 months. So clearly, much better efficacy when we're going to the intracameral delivery.

Our next question comes from David Steinberg with Jefferies.

It's actually Ed Chung on for Dave. Quick question on the -- historically, you talked about 5,000 inserts per month as a threshold for achieving breakeven on your commercial platform. Now was that before or after your sales force expansion?

Yes. That was before our sales force expansion. Clearly, we've added a few people, not a huge amount, but we're spending about $7 million now on our total marketing and sales effort. So yes, we've ramped up a bit. That number would be a bit higher. So it's probably be closer to 7,500 units to get to breakeven.

Got it. All right. Great. And in terms of R&D spend, I mean how should we be thinking about the ramp as these programs go into Phase II and obviously, it's probably going to cost you a little more and your ability to fund them into Phase IIs?

Well, we've stated that we have sufficient cash and cash equivalents to be able to fund all of the programs that we have through their Phase II readouts.

So we're comfortable with obviously a counter set of an expectation for DEXTENZA sales. We're currently running ahead of our expectations on DEXTENZA sales. So we feel pretty comfortable that we are -- we don't have a cash issue through those readouts. But you are right, the costs would be increasing as we enter Phase II and a larger Phase I study with TKI.

Our next question comes from Anita Dushyanth with Berenberg.

Congrats on the progress. Just wanted to know if you could remind us the market opportunity in the acute versus chronic dry eye disease, and also recently -- I assume this was approved for the acute treatment, I think. And I just wanted to know how -- when the DED candidate comes on, it would fare in the market, is there -- is it going to be filling some gaps or displacing the competition?

Yes. I'll take the first part of the question, and then Mike obviously is not only our CMO, but he's also a practicing ophthalmologist. So he can sort of let you know, from an ophthalmologist standpoint, what they mean. First of all, Kala, we have to thank them for actually creating the indication for short-term treatment. It was very creative of them and very, very good dialogue that they had with the FDA in order to be able to create that opportunity. What the relative sizes of the short-term market is relative to the chronic, it's hard to say at this point, because the short-term market is so new.

I think it's pretty clear to say though that the chronic market is comfortably larger and orders of magnitude larger than what the short-term market would be.

So the sizes are considerable for both, but we feel certainly that the chronic market is far larger. Considering the differences that our DED program would bring on the short-term treatment relative to what you see with EYSUVIS or with off-label steroids is that we would be obviously physician-administered. So there would be a non-abusability aspect to the product.

So the doctor's putting it in, it releases its product and then the insert bioresorbs and goes down the nasolacrimal duct. So the patient is actually taken out of the equation, and overuse of steroids is one of the worries that doctors have when they treat either short or they certainly wouldn't treat long term, but they would treat short-term dry eye that they worry that patients would like the way they work so much that they would find somebody else's drops and continue to use them and then they would develop elevated intraocular pressure and cataracts.

So we would have that advantage. We would also be a preservative-free product. Currently, there are no preservative-free steroids on the market. Many patients do respond to preservatives. Particularly when you have a dry eye condition, you have a compromised ocular surface. Putting a preservative on a compromised ocular surface is generally not advisable.

And finally, we of course would have a (inaudible) product that has procedure code attached. So the office environment, the office economics would be substantially different than a Part D product where you're writing a script and the patient is going to the pharmacy to fill that script. So they'd be very different products. I think they would build -- there's certainly a space for both of them. And I think EYSUVIS has got a really great future in front of it.

It's a fantastic product, and Kala has done a fantastic job in creating this indication. I don't know, Mike, do you want to add some more to the overall answer?

That was pretty complete response. You almost sounded like an ophthalmologist. I would just add, I mean this is a market that we as ophthalmologists have access for a long time. We know that steroids have been very effective for treating patients with inflammatory flares with dry eye, and it's pretty common. And we've used off-label low-dose steroids or compounded steroids for a long time.

As Antony mentioned, shout out to Kala in particular, their Chief Medical Officer, Kim Brazzell, who worked with FDA to actually get this as an approvable indication. I think a lot of us didn't actually think that would happen.

So we've sort of looked at what they've done. We think this is a really, really interesting opportunity. I think the big clinical advantage we offer, as Antony said, is that we're not an eye drop. This is physician administered in the office. It can't be abused by patients. And therefore, the concerns that we have as physicians about using steroids for dry eye, which are that patients will overuse them and develop adverse events like glaucoma or cataracts, go off the table, because patients can't abuse it. It can only be placed by the physician. I think that's the big clinical advantage that we offer here, but we're really excited about this as a potential indication.

(Operator Instructions) Our next question comes from Yi Chen with H.C. Wainwright.

This is Boobalan dialing in for Yi Chen. So if you could comment on your expectations for DEXTENZA adoption for the year 2021, that would be appreciated. And do you anticipate any potential roadblocks as the country's coming out of COVID-19 with an impressive vaccination rate?

Yes. We have not given formal guidance about DEXTENZA, but the market is fast returning to a normal situation, where the COVID is no longer seemingly affecting our customers. So our excuses for not giving guidance are probably going away, but we have not given that. What we've done instead is we've given extraordinary transparency into our in-market sales and billable units, which really is a pretty granular level of a look into what our sales are. We would at some point switch to giving guidance and then give also only quarterly net sales. But until we do that, we won't give guidance.

All right. Understood. Could you comment on the Phase II program for OTX-DED other than what has been stated in your press release and what are your expectations from the trial? And when can we hear about the interim findings?

So the OTX-DED Phase II program is 150 subjects. It's 2 different formulations of the OTX-DED against a vehicle insert. The primary endpoint is looking at conjunctival redness at 2 weeks, but we're also looking at other signs and symptoms of dry eye disease. The trial enrollment is going very well despite COVID. Things have moved along as much as it did with the CSI trial. There is no interim look at the data, but we've disclosed that we will release the top line data in the first half of next year.

All right. One final question from me. So do you think DEXTENZA for allergic conjunctivitis will be priced differently?

No, we can't price it differently. It's the same NDA. The price will be the same.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.