Ocular Therapeutix, Inc Q2 FY2020 Earnings Call

Good morning, everyone. Thank you for being here, and welcome to the Ocular Therapeutix Second Quarter 2020 Earnings Conference Call. It is now my pleasure to hand the call over to Donald Notman, Chief Financial Officer at Ocular Therapeutix. Please proceed.

Thank you, Kevin. Good morning, everyone, and thank you for joining us on our second quarter 2020 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 June 30, 2020. 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 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 second quarter before turning the call back over to Anthony for a summary and questions. As a reminder, on today's call, certain statements we will be making may be considered forward-looking statements 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. And 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 Form 10-Q on file with the SEC. I will now turn the call over to Antony.

Thank you, Donald, and welcome, everyone, to Ocular Therapeutix's Second Quarter Earnings report. I'm pleased to report that despite the challenges caused by the global pandemic, it has been a very productive quarter for Ocular as we have positioned the business well for the second half of the year. As I've said in past calls, one of the great benefits of Ocular Therapeutix is that despite being a small company, our technology platform allows us to advance many programs across several of the most valuable segments in ophthalmology such as retinal diseases or wet AMD, glaucoma, ocular surface disease, including dry eye disease and allergic conjunctivitis, and post-surgical inflammation and pain. Beginning with the largest of these value drivers, wet AMD, the global market for retinal diseases was approximately $13 billion in 2019 and is estimated to grow at 11% over the next five years. A key driver in the treatment selection for wet AMD is durability. The longer a treatment works to keep a patient without fluid on a single injection, the greater attractiveness of the treatment in general. Current standard of care typically has patients needing reinjection every four to eight weeks. In the space of the last few quarters, OTX-TKI, our wholly-owned intravitreal tyrosine kinase inhibitor eluting implant designed to deliver up to six months of therapy with a single injection, has shown a favorable signal in the clinic, and we believe has the potential to set the standard of care for durability of treatment for wet AMD. We look forward to providing further clinical updates on this key program in the fall. In addition to OTX-TKI, Occular is working on a second product for wet AMD with our partner, Regeneron, to develop an extended delivery suprachoroidal injection formulation of the FDA-approved VEGF trap aflibercept. As many of you know, this has been a long-standing collaboration. But what many may not know is that in May, we successfully amended the collaboration whereby Regeneron will compensate Ocular Therapeutix on a cost-plus basis for all work performed under the preclinical portion of the collaboration. There's no change to the back-end economics of the original agreement to provide for potential option exercise fees and milestone payments of $305 million and tiered escalating royalties from the high-single digits into the low- to mid-teens. We are thrilled to continue our work with Regeneron. We are more excited than ever about the potential value this collaboration could bring to Ocular. Moving to glaucoma. A market worth nearly $5 billion in global annual sales where possibly the greatest unmet need is for a product that ensures better patient compliance. As we mentioned on the call last quarter, we have confidence in the regulatory path for OTX-TIC, our travoprost-eluting intracameral implant, and we believe our hydrogel platform can potentially offer additional safety and durability benefits. With the magnitude of IOP lowering at least as good as prostaglandin drops given in a clinical trial setting and a potential durability of six-plus months from a single insert, we believe OTX-TIC has the potential to become standard of care for treatment of elevated IOP in glaucoma. For the treatment of ocular surface diseases such as dry eyes and allergic conjunctivitis, we have seen positive developments this quarter. In the treatments of dry eye disease, by far the largest segment of ocular surface disease, we now have two products. OTX-CSI is our cyclosporine intracanalicular insert for the treatment of chronic dry eye, and we have added OTX-DED, a product candidate designed to treat episodic dry eye disease. With the addition of OTX-DED, along with OTX-CSI, we now have two potentially transformative products, one to treat chronic forms of the disease and the other to treat acute disease, thereby effectively covering the broad spectrum of the approximate $5 billion dry eye disease market. In allergic conjunctivitis, we remain on track to file our sNDA application by the end of the year. Notably, allergic conjunctivitis could represent DEXTENZA'S first ocular surface disease indication and be the first indication used primarily in the ophthalmology office environment. Now turning to DEXTENZA for the treatment of post-surgical inflammation and pain. On the sales side, we reported $1.4 million in DEXTENZA net product revenue for the second quarter. After a near total shutdown in cataract surgeries in April, DEXTENZA bounced back strongly and recorded a record month in June. Billable inserts to Ambulatory Surgery Centers and hospitals, our key metric of end market demand, increased from only 64 inserts in April, when cataract volumes were down 97% nationally, to nearly 2,300 inserts in June, exceeding by 40% the previous pre-COVID monthly high and breaking the $1 million threshold in market in a calendar month for the first time, a threshold we cleared again in July. Despite the fact that many ASCs and HOPDs are still either nonoperating at capacity or operating at reduced capacity, the record month suggests that DEXTENZA has earned an increased share of cataract volume in the post-COVID environment. We believe the market sees our hands-free alternative to drugs as compelling, and we expect to see this momentum carrying over into the third quarter. Adding to our confidence in DEXTENZA sales are two potential accelerators as we head into the second half of the year: first, we initiated a new rebate program that is being well received, especially by the large, typically private equity-backed ASC consolidators that now dominate the cataract space; secondly, we recently announced that two Medicare administrative contractors, or MACs, Novitas and First Coast, have established physician fee schedules for reimbursement of procedure code 0356T, the CPT code for the placement of a drug-eluting intracanalicular insert, including DEXTENZA. What this means is that physicians inserting DEXTENZA can expect a professional fee payment of between $95 and $115 for each insertion, which is separate from the reimbursement for the drug itself. First Coast and Novitas cover nearly 30% of all Medicare beneficiaries. In addition, four of the remaining five MACs have retired their non-coverage policies for 0356T, and we eagerly await the publication of fee schedules from them. Overall, we think these goals represent significant catalysts that, along with a return to more normal cataract volumes, will further help us build on the momentum we are seeing with DEXTENZA. In summary, Ocular Therapeutix is making important strides in the development of its portfolio, but is also being helped by changes in the competitive market and the overall environment. As we look at Ocular's prospects, even a few quarters prior, we see a different outlook today. Across the spectrum of wet AMD, glaucoma, dry eye disease, allergic conjunctivitis and the prevention of post-surgical pain and inflammation, our products have progressed substantially. With that, I will now turn the call over to Mike Goldstein.

Thanks, Antony. Let me begin with an update on our back-of-the-eye program. OTX-TKI is a bioresorbable hydrogel implant containing axitinib which has anti-angiogenic properties and is delivered by intravitreal injection and designed to extend the durability of treatment for wet AMD. It's being developed to treat patients with wet age-related macular degeneration and other retinal diseases, such as diabetic macular edema and retinal vein occlusion. We continue to dose subjects in a multicenter, open-label dose escalation Phase I clinical trial in Australia that is designed to assess the safety and tolerability of OTX-TKI as well as to assess preliminary biological activity by measuring anatomical and functional changes. The first two cohorts are now fully enrolled, and a third cohort is currently enrolling. The data demonstrate that OTX-TKI in both cohorts is generally well tolerated with a favorable safety profile with no serious ocular adverse events reported to date. While still early, initial interim data suggests that there is a dose response as evidenced by a greater clinical response in the second higher-dose cohort compared with the first lower-dose cohort. In the higher dose cohort, several treated subjects showed a decrease in retinal fluids as measured by decreases in intraretinal and/or subretinal fluid with the longest treated subject with wet age-related macular degeneration now up to 7.5 months without needing anti-VEGF treatment. Additionally, some patients in cohort 1 who will require frequent anti-VEGF dosing prior to enrollment in the study were shown to potentially not need rescue therapy for as long as 10 months after being treated with OTX-TKI. While the drug's product profile is still emerging, we are pleased with the interim data that suggests intravitreal injection of a TKI can potentially reduce intraretinal and/or subretinal fluid. In terms of upcoming milestones for OTX-TKI, we're enrolling a third cohort of patients where half the patients will be dosed at 600 micrograms and half of the patients will receive a 400-microgram dose and an anti-VEGF induction injection. We plan to give an update on this study at a medical conference in the fall. We are also on track to submit an exploratory IND to the FDA by the end of the year and start dosing in the United States for wet AMD, DME, and retinal vein occlusion. Moving to our glaucoma program. OTX-TIC is a bioresorbable, travoprost-containing hydrogel implant delivered via an intracameral injection designed to deliver an extended duration of IOP reduction. We continue to enroll subjects with primary open-angle glaucoma or ocular hypertension in a Phase I prospective, multicenter, open-label dose escalation clinical trial in the United States to evaluate the safety, biological activity, durability, and tolerability of OTX-TIC. Data from the first two fully enrolled cohorts showed decreased IOP in patients receiving OTX-TIC that was comparable to current standard of care, topical travoprost, in place in the non-study eye. The data showed that the IOP remained consistently decreased for an extended duration of six to nine months in many subjects for the single implant and one subject had IOP control for over 21 months for the single implant. In terms of next steps, we have completed enrollment in cohort 3, which has the same dose as cohort 1 but is using a more rapidly degrading hydrogel implant and are currently enrolling cohort 4, which is a smaller implant at a lower dose. We are targeting initiating a Phase II clinical trial for OTX-TIC in the first half of 2021. Next, we have some exciting programs to discuss in the area of ocular surface diseases, which includes the large potential markets of dry eye and allergic conjunctivitis. For dry eye, we have two programs. OTX-CSI is addressing dry eye patients with chronic disease, and we recently announced a new program, OTX-DED, targeting patients with episodic or dry eye flare. We've also completed Phase III trials evaluating DEXTENZA for the treatment of patients with allergic conjunctivitis. OTX-CSI is an intracanalicular insert, which combines two modalities commonly used to treat dry eye patients. OTX-CSI is designed to release cyclosporine for approximately three months to the ocular surface and to provide punctal occlusion over that time period. By releasing a low dose of cyclosporine over an extended duration of time, OTX-CSI has the potential to minimize what we believe is one of the biggest patient complaints about topical cyclosporine, which is stinging and burning. By combining drug release with punctal occlusion, OTX-CSI has the potential to provide more rapid onset of symptomatic relief for patients with cyclosporine alone. For OTX-CSI, we have recently completed enrollment of the Phase I clinical trial. Patients have been treated with OTX-CSI for a number of weeks. The safety committee has met and was supportive of moving to Phase II clinical trials. We remain on track, if the data from the Phase I clinical trial is favorable, to begin enrolling the randomized double-masked placebo-controlled Phase II clinical trial by the end of the year. We are very excited about the potential for this hands-free option in helping dry eye patients receive the benefits of cyclosporine over a rate with a potentially greater tolerability and more rapid clinical benefit compared to therapies currently available on the market. Our newest product candidate, OTX-DED, is a low dose intracanalicular insert of dexamethasone for the treatment of patients with episodic dry eye disease. While it incorporates the same active drug as DEXTENZA, this is a new product candidate with a lower dose and smaller insert size. Many of these dry eye patients experience episodic flares of their signs and symptoms, which we believe are likely related to inflammation. Currently available topical steroids are used off-label for dry eye patients and have preservatives, which can result in ocular surface toxicity. This may also lead to adverse events such as elevated IOP or cataracts if used chronically. OTX-DED potentially offers these patients the opportunity to be treated with a non-abusable physician-administered, preservative-free, and hands-free steroid therapy. Because OTX-DED has a lower concentration of dexamethasone compared with DEXTENZA, we are able to leverage the DEXTENZA safety package generated to date. We plan to file an investigative new drug application with the U.S. FDA, evaluating OTX-DED in dry eye disease by the end of 2020 with the plan to move directly into Phase II clinical trials in patients with dry eye disease. In allergic conjunctivitis, we remain on track to submit our sNDA by the end of 2020. Overall, we believe the data package highlights a compelling product profile targeting unmet need that could potentially change the current standard of care for the one-time, long-acting, hands-free therapy for treatment of ocular itching associated with allergic conjunctivitis. This sNDA, if approved, would represent our first in-office indication. Lastly, before turning the call over to Donald, I would like to add that there continues to be significant interest and excitement in evaluating DEXTENZA in many areas of unmet need with over 70 investigator-initiated trials requests submitted. We currently have 14 IITs that are active in enrolling subjects, including two that have completed enrollment. I would now like to turn the call back over to Donald.

Thanks, Mike. The gross product revenue, net of discounts, rebates, and returns, which the company refers to as total net product revenue, was $1.6 million for the three months ended June 30, 2020. Net product revenue of DEXTENZA and ReSure Sealant in the second quarter were $1.4 million and $0.2 million, respectively. Research and development expenses for the second quarter were $8 million versus $9.4 million for the comparable period in 2019 and primarily reflect the decrease in personnel and unallocated costs due to the organizational restructuring announced in November of 2019. Selling and marketing expenses for the second quarter was $6.2 million as compared to $7.2 million for the same quarter in 2019, stemming primarily from a decrease in travel, consulting, marketing, and conference expenses as a result of the COVID-related slowdown in the commercialization of DEXTENZA. Finally, general and administrative expenses were $5.1 million in the second quarter of both 2020 and 2019, with a modest increase in facilities expenses being offset by decreased professional costs in Q2 2020. With respect to financial results for the second quarter, we reported a net loss of $36.6 million or a loss of $0.64 per share on a basic and diluted basis. This compares to a net loss of $24.5 million or a loss of $0.57 per share on a basic and diluted basis for the same period in 2019. The net loss for the second quarter included $2.5 million in non-cash charges for stock-based compensation and depreciation compared to $2.3 million for the same quarter in 2019. In addition, the net loss for the quarter includes a non-cash charge of $17 million related to the change in the fair value of the derivative liability associated with our convertible notes, primarily as a result of the significant increase in our stock price compared to the prior quarter. As of August 1, 2020, the company had approximately 63 million shares outstanding. As of June 30, 2020, the company had $84.3 million in cash and cash equivalents versus $48.2 million at the end of Q1 2020. The cash balance benefited during the second quarter from $48.3 million in net proceeds generated from a public stock offering in May and also from net proceeds of $1.7 million from the sale of common stock under the company's 2019 Sales Agreement under which the company may offer and sell its common stock having aggregate proceeds of up to $50 million from time to time. Approximately $1.3 million of common stock remains available to be sold under the 2019 Sales Agreement. Based on current plans and including related estimates of anticipated cash flows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating expenses, the company believes that existing cash and cash equivalents as of June 30, 2020, will enable the company to fund planned operating expenses, debt service obligations, and capital expenditure requirements for at least the next 12 months. This cash guidance is subject to various assumptions including those related to the severity and duration of the COVID-19 pandemic and expect a continued rebound in cataract surgeries beginning in the third quarter and other assumptions related to revenue expenses associated with the commercialization of DEXTENZA, variable expense reductions, and the pace of research and clinical development programs as well as other aspects of the company's business. This concludes my comments on the second 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 to questions, let me do a quick summary. In wet AMD, the performance of OTX-TKI in the clinic continues to support a product profile that could potentially set a new standard of care for durability. We look forward to providing further clinical updates later this fall. In glaucoma, OTX-TIC continues to support a 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 first half of 2021. In ocular surface disease, for OTX-CSI for treatment of chronic dry eye disease, we have completed enrollment in Phase I, and if successful, plan to enter Phase II before year-end. For OTX-DED, our newly announced treatment for acute dry eye, we plan to file a Phase II-enabling IND before year-end and if accepted, enter Phase II shortly thereafter. Beyond dry eye disease, we remain on track to submit our sNDA for DEXTENZA and allergic conjunctivitis by the end of the year. For DEXTENZA, in postoperative inflammation and pain, we have seen accelerated momentum in sales uptake in June and now in July as well, and are optimistic such momentum will continue in the quarter. With the added benefits of a new rebate program and Medicare reimbursement of the procedure associated with DEXTENZA, we look forward to even greater growth in the future. So in summary, it has been a very productive quarter, and we look forward to continued productivity in the second half of the year with a number of key catalysts within our pipeline and continued momentum with DEXTENZA. With that, I will turn the call over for questions.

Our first question comes from Joe Catanzaro with Piper Sandler.

Congrats on the progress, especially given the backdrop. Maybe first, just a couple on TKI. The data update that we expect to see later this year, should we expect just an update for the first 12 patients in the first two cohorts? Or is there potential to see initial data from the patients treated in the third cohort? And then maybe as a follow-up to that, what are the plans once the exploratory IND in the U.S. is cleared? Are the next steps there dependent on what you've seen in cohort 3? Maybe you could just walk us through how the development program evolves once you can dose in the U.S.

Thanks, Joe. This is Mike speaking. Regarding your first question, we plan to provide an update on TKI in the fall. We have several meetings planned. As you know, we will update you on the first 12 patients in cohorts 1 and 2. We are actively enrolling cohort 3, and depending on the enrollment progress, if we have significant information to share, we may offer an update on cohort 3, but we are not committing to that right now. Concerning the exploratory IND, our goal is to file it in the U.S. by the end of the year. This exploratory IND would potentially allow us to treat patients with AMD, diabetic macular edema, and retinal vein occlusion. In addition, we are working on some changes to the formulation for the higher-dose implants and conducting toxicity studies in parallel. After we update the formulation and complete the necessary toxicity work, we intend to begin a Phase II trial.

Okay. Got it. That's helpful. Maybe just a follow-up and one on DEXTENZA here. Do you guys have visibility into the extent of physician utilization of 0356T? If so, what have you seen since the update of those two MAC fee schedules? And is 0356T something you guys can specifically promote too?

It's still a bit early to assess physician utilization. There was some hesitation regarding 356T before consistent reimbursement was established. Due to the accounting practices in some ASCs, they preferred to avoid non-payments, even if there was no cash outflow. However, we're now seeing growing evidence of reimbursement across the board. Reimbursement is certainly occurring within First Coast and Novitas, and we are also observing it in other MACs that have not yet issued a fee schedule. We are gathering as much data as possible. Clearly, we will not market this directly to physicians; they should learn about it through their MACs and ASC administration. Additionally, when using DEXTENZA, we recommend they code for 356T as well, but we won't provide guidance on how to secure reimbursement.

Our next question comes from Yi Chen with H.C. Wainwright.

My first question is, could you give us some additional color on the timeline of development for those two dry eye candidates and which product could potentially reach the market first?

Yes. I'll start off and then hand it off to Mike for maybe a more specific discussion about how to bring these forward. DED, the product with dexamethasone that is, at the moment, going to enter Phase II probably slightly behind CSI, given the nature of the trials, and the shorter duration of treatment, it's probably likely to overtake CSI in its development. So even though it's yet to file its IND in the states, it is probably going to be the one that reaches the market first. That being said, there's a number of different opportunities we can follow in terms of how we bring these to the market, particularly because we have active comparators or would imagine we would have active comparators in both of these indications. So I'll hand over to Mike to talk specifically about how we would conduct those trials going forward.

Thank you, Yi. As Antony mentioned, the cyclosporine CSI program is currently active. We have completed enrollment for the Phase I program and are on track to begin the Phase II program by the end of the year. This product is designed to release cyclosporine over approximately three months and specifically targets typical dry eye, which is a chronic disease state. We will need to conduct long-term safety assessments and similar studies. The DED program uses a lower concentration of dexamethasone and aims to address acute dry eye or flares. We plan to file the IND with the FDA by the end of the year and move swiftly into clinical trials. Based on our knowledge from DEXTENZA, we expect to transition directly into Phase II trials with dry eye patients experiencing acute flares. The goal is for this product to be effective for less than a month without chronic dosing. Although the DED program will start second in our trial efforts, it is anticipated to progress faster than CSI. Importantly, we will not require long-term dosing, which will facilitate a quicker path to market for the DED program.

Got it. And just to follow-up, for DED, do you need to meet both sign and symptom endpoints in a pivotal trial? And for CSI, do you only need to meet the Schirmer's test endpoint in a pivotal trial?

Yes, that's a great question. Generally, for both indications of dry eye, we are focusing on a sign and symptom endpoint in adequate and well-controlled trials. There are some exceptions, such as the Schirmer's test, but that is not our primary target. Our aim is to establish signs and symptoms in adequately controlled trials.

Our next question comes from Dane Leone with Raymond James.

Congratulations on the progress of the CSI and DED. I wanted to ask a slightly different question. What is the comparative standard for these studies that you need to demonstrate versus the widely available drops? How do you think about that? What feedback have you received from your discussions with clinicians regarding what they would want to see in either the chronic or acute setting to consider using an insert?

Thank you, Dane. That's a very good question. From a regulatory standpoint, there are two possible pathways for comparators. The typical approach has been to demonstrate statistically significant superiority over a vehicle comparator, which is how many drugs in the dry eye sector have received approval. With the approval of two drugs in the United States, cyclosporine and lifitegrast, for chronic conditions, there's now the option to directly compare against an active comparator and demonstrate non-inferiority for OTX-CSI. Regarding OTX-DED, there are currently no approved drugs for the acute or dry eye flare situation. However, there may be a drug approved later this year, which we believe is likely, and if that happens, it could serve as an active comparator in trials.

Physicians are looking for treatments that minimize burning and stinging, particularly concerning cyclosporine, and they want options that have a quicker onset of action. We believe that CSI addresses both of these concerns. On the dry eye disease side, when treating a flare with a steroid, there’s a demand for a non-abusable product. Our formulation is administered by physicians, is non-abusable, and lacks preservatives, similar to CSI. Furthermore, these products will introduce a unique opportunity for revenue generation for physicians and their offices since there is currently no revenue stream in the treatment of dry eye or dry eye flares. With CSI and DED, which would be deployed using 356T, physicians can code for an additional procedure. These will be buy-and-build products purchased by physicians' offices, creating opportunities for rebates and potentially higher margins. Thus, we believe these offerings not only fill a market gap in efficacy compared to existing or soon-to-be-released products but also open new revenue avenues for physicians.

Great. If I could ask a follow-up on that since you mentioned it, how do you think consumers would feel about an insert based on your market research? Are there specific aspects of compliance or utilization seen with the drops that highlight convenience or treatment effectiveness that the clinical community understands, or would that need more education from your side?

It's well-known that most people are not fond of using eye drops. This is a straightforward observation. Additionally, with cyclosporine, the burning and stinging sensation caused by the drops is a significant issue. If we can address these problems, we can improve patient satisfaction. The quick onset of action is also important. For instance, when looking at Restasis, it's evident that patients discontinue therapy very quickly, and the number of prescriptions filled after six months to a year is extremely low, primarily due to the delayed effects and the discomfort associated with the drops. In light of these factors, I believe we would be successful with patients even in a self-pay situation. Mike, would you like to add anything?

Yes. To add to that, you bring up an excellent point, Dane. One of the primary methods we currently use to treat dry eye is punctal occlusion with punctal plugs. Placing something into the canaliculus is standard care for our dry eye patients. In this context, there isn’t a significant change in the approach. What has changed is that in addition to achieving punctal occlusion, we are now also providing an active drug release over a period of time.

Our next question comes from Jonathan Wolleben with JMP Securities.

A lot of mine have been answered, but just a couple. First on DEXTENZA. Now that we're getting further along in the launch, and we've gotten past COVID and you have some of these medical, administrative contractors coming on board. Have you thought about providing guidance either later this year or next to give us a better feel for long-term demand?

Yes. We will provide guidance in the future, but we currently face three significant factors that complicate our ability to predict DEXTENZA sales for the next quarter. The first and most uncertain factor is the impact of COVID on elective surgeries. While we lack solid data, anecdotal feedback suggests that activity is currently around 50% of normal. This level seems stable, even as some regions experience increased intensity. The second factor is the new rebate program, which is expected to impact us more in the fourth quarter than in the third, although some effects will be felt in the third quarter. Lastly, there is the reimbursement for 356T. Due to these three factors, we believe that providing forward guidance at this time would not be particularly useful. However, by the end of the third quarter, we should have more clarity on how these major factors will affect us moving forward. Once we are confident in our outlook, we will begin guiding the market accordingly.

Great. Looking across the landscape, Roche recently shared some Phase III data in wet AMD for a port delivery system. I would like to hear your thoughts on that approach and any comments you may have on their data.

Yes, I think it's a very large market and people are looking for a longer-lasting therapy. The Roche data is quite interesting, though it involves a surgical procedure and there are some technical challenges with the delivery system. However, it seems like a promising option. What we provide is probably a more straightforward way to administer the medication. The TKI operates by inserting an implant using techniques similar to those used for current anti-VEGF therapy, which means there’s no need for a change in skill set. Retina specialists, as well as a growing number of non-retina specialists who are increasingly performing anti-VEGF injections, would be able to place it. In many respects, I see them as potentially complementary to one another.

And since there are no further questions at this time, this does conclude the Ocular Therapeutix Conference Call. You may all disconnect, and have a wonderful day.