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spk00: Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutics fourth quarter and year-end 2021 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 Donovan, Chief Financial Officer of Ocular Therapeutics. Please go ahead, sir.
spk02: Thank you, Catherine. Hello. Good afternoon, everyone, and thank you for joining us on our fourth quarter and year-end 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 and fiscal year ended December 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 Anthony Monacich, our President and Chief Executive Officer, who will provide a summary of our corporate developments and an update on the commercial progress of Dextenva. 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 quarter. and the fiscal year before turning the call back over to Anthony for a summary and questions. For Q&A, we will be joined by Scott Corning, our Senior Vice President, Commercial, and Chris White, our Chief Business Officer. 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 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 annual report on Form 10-K filed this afternoon with the SEC. I will now turn the call over to Anthony.
spk05: Thank you, Donald, and welcome, everyone, to the Ocular Therapeutics Fourth Quarter and Year-End 2021 Earnings Report. Ocular's had another strong quarter and a productive year. The commercial division of Xtensa continues to ramp. We achieved $12.3 million in total net product revenues in the fourth quarter and $43.5 million for 2021. This represents a 66% growth over the comparable quarter in 2020 and 150% growth in 2021 on a full year basis. I'm pleased with our commercial efforts and our team's ability to grow product revenues in each quarter of 2021 despite lower than expected cataract surgery volumes attributed to the COVID pandemic. Xtensa represents a tremendous growth forever for Ocular as we continue to put ourselves in the best possible position to grow the product. We've made significant progress on reimbursement as we enter 2022 with Xtensa currently maintaining pass-through payment status through 2022, and then very importantly, being eligible for separate payment beginning in 2023 and potentially beyond as a non-opioid pain management supply provision in ASCs. In addition, physician reimbursement for the insertion of Dextenza is now broadly available under our Category 1 code, which became effective January 1, 2022, ensuring reliable payment to physicians for Dextenza placement across all payer types and in all settings of care. In October, we received FDA approval of our SNDA expanding the use of Dextenza for the treatment of ocular itching associated with allergic conjunctivitis. This approval represents an important strategic milestone, not just because it expands the market opportunity for Dextenza, but because we believe it opens up growth potential in a new site of care, the ophthalmology and optometric office environments. Allergic ineptivitis is treated in the office environment, as opposed to the ASC and HOPD, where Dextenza gets the vast majority of its current use in the treatment of post-surgical inflammation and pain. Ocular's strategic goal is to expand its presence into ophthalmology and optometric offices by providing customers with numerous innovative buy and build products, including those developed internally and potentially those in license from other companies in the future. The approval of this NDA gives us the opportunity to take the first step in doing that. While the strategic potential of the office environment is exciting, it represents an almost entirely new space for ocular therapeutics with a unique set of challenges and opportunities. We discovered in the launch of Xtensa that the primary barriers of entry were the logistics associated with ASC and HOPD administration. Setting up accounts in ophthalmology and optometric offices will be analogous, but with different drivers that require bespoke solutions. As a result, in 2022, we are establishing a separate business unit consisting of key account managers and field reimbursement managers who will be tasked exclusively with selling into the office setting. This effort will expand our commercial footprint and provide the opportunity to further enhance the growth of Dextenza and may also facilitate longer-term the commercialization of any of the product candidates in our pipeline that may be approved, including potentially OTX TKI and wet AMD, OTX TIC and glaucoma, and our dry eye products, all of which are designed to be used predominantly in the office setting. Shifting to our pipeline, we have also made great progress advancing our key programs, We recently provided updates on OTX TKI for the treatment of wet AMD at the angiogenesis exudation and degeneration meeting and on OTX TIC for the treatment of glaucoma at the glaucoma 360 meeting. Both updates continue to demonstrate drug product profiles that we believe are compelling and could dramatically improve upon the standard of care in these billion dollar markets. We anticipate significant milestones in both programs over the course of 2022. Clearly, We believe our pipeline remains a source of tremendous potential value. We continue to advance the portfolio of product candidates that are highly differentiated clinically, that lend themselves to efficient commercialization, and have the potential for long periods of exclusivity. With that, I would now like to hand the call over to our President of Ophthalmology and Chief Medical Officer, Dr. Michael Goldstein, who will provide an in-depth look at our pipeline.
spk03: Thanks, Anthony. Let me begin with an update on our back-of-the-eye program, OTX TKI. We are pleased to have recently completed enrollment in the U.S.-based multicenter prospective randomized control trial that is evaluating a single 600-microgram OTX TKI implant containing axitinib compared to a Flibersep administered every eight weeks in subjects previously treated with anti-VEGF therapy. This U.S.-based a total of 20 randomized subjects with 3-to-1 randomization weighted toward OTX TKI-treated subjects. We plan to report interim six-month data in the second half of the year. This trial 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 of the retina. Critical to remember is that the population being studied here is different than the population being studied in our ongoing Phase I clinical trial of OTX TKI in Australia. In this trial, we are including only subjects who have been previously treated with anti-VEGF therapy and asking the question, how long can we maintain subjects without need for re-treatment? Whereas in the Australian trial, we studied subjects who had pre-existing inter-retinal and inter-subretinal fluid and ask the question, could we get rid of the fluid with the TKI? We recently presented the interim data on OTX TKI from the Australia-based Phase I trial at the Angiogenesis, Exudation, and Degeneration 2022 meeting held on February 11th and 12th. This latest analysis of interim data in subjects with subretinal and or intraretinal fluid due to wet AMD continues to support the product safety profile and preliminary evidence of biological activity, In this trial, we found a clinically meaningful decrease in intraretinal and or subretinal fluid in many subjects. Extended duration of activity of six months or more was observed in over 60% of subjects across all cohorts, and over 80% of subjects in cohort 3A, the 600-microgram cohort, which could represent a compelling drug product profile. Moving to our glaucoma program, OTX-TIC, We recently presented data from the completed U.S.-based Phase I clinical trial evaluating the safety, biological activity, durability, and tolerability of OTX TIC in subjects with primary opening glaucoma or ocular hypertension at the Glaucoma 360 meeting on February 11th. The Phase I data presented highlights OTX TIC's ability to provide a clinically meaningful decrease in intraocular pressure comparable to the trauma process, as early as two days following administration, and for as long as six months or more with a single implant, while preserving corneal health, representing its potential for a unique and differentiated drug product profile. With this data in hand, we've initiated a U.S.-based Phase II clinical trial on our actively screening subjects. This trial is a prospective, multi-center, randomized controlled trial evaluating the safety, tolerability, and efficacy of OTX-TIC for the treatment of patients with primary open-angle glaucoma or ocular hypertension. The trial will enroll approximately 105 subjects in three different arms, 35 subjects per arm, randomized one-to-one-to-one, in which the subjects will receive a single OTX TIC implant containing a 5-microgram or 26-microgram dose of Travafrost compared with an injection of Durista. The trial will observe the changes in diurnal intraocular pressure changes from baseline at 8 a.m., 10 a.m., 4 p.m., at 2, 6, and 12 weeks, and follow duration of IOP response over time. Regarding our ocular surface disease programs, we remain committed to the development of our two dry eye programs, OTX-DED, a low-dose intercanalicular insert of preservative-free dexamethasone for the short-term treatment of the signs and symptoms of dry eye disease, and OTX-CSI for the chronic treatment of patients with dry eye disease. In December 2021, we announced positive top-line results from our Phase II clinical trial of OTX-DED. The Phase II clinical trial was a U.S.-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different formulations of OTX-DED, a 0.2-milligram group and a 0.3-milligram group in 166 subjects with dry eye disease. While not powered for statistical significance, the clinical trial achieved its pre-specified primary endpoints demonstrating a statistically significant change of vulvar conjunctival hyperemia from baseline to day 15 compared to the vehicle hydrogel using a central reading photographic assessment in the modified ITT population at both doses, p-value of 0.004 in the 2 mg group and p-value of 0.028 in the 0.3 mg group. OTX-DED was observed to be generally well tolerated with a favorable safety profile. Overall, we were pleased with the OTX-DEV results and we continue to see a large treatment effect from the punctal occlusion using the control arm. We are currently reviewing an appropriate clinical regulatory development and manufacturing plan. This plan will include some additional formulation work for the OTX-DEV insert and the development of an appropriate vehicle comparator. In late March, October of 2021, we reported top-line data from the U.S.-based Phase II randomized double-mask multicenter clinical trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus hydrogel vehicle insert. The Phase II study showed that OTX-CSI-treated subjects got a clinically meaningful improvement from baseline for both science and symptoms of dry eye disease for both formulations. This trial, however, did not show separation between the OTX-CSI-treated subjects, both formulations, and the vehicle-treated subjects, both formulations, on symptoms where the primary endpoint of increased tear production at 12 weeks is measured by the Shermer's test. We are currently reviewing an appropriate clinical regulatory development and manufacturing plan. This plan will include additional formulation work for the OTX-CSI insert to allow improved retention and the development of an appropriate vehicle comparator. I would now like to turn the call back over to Donald to review our fourth quarter and year-end financial results.
spk02: Thanks, Mike. Gross product revenues net of discounts, rebates, and returns, which the company refers to as total net product revenue, was $12.3 million for the fourth quarter and represented a 66% increase over the same period in 2020. Net product revenue of the extent in the fourth quarter was $12.2 million and versus $6.9 million in the comparable quarter of 2020, reflecting a 77% increase. Total net product revenue for the fourth quarter of 2021 also includes net product revenue of $58,000 from insured sealant. Overall, net product revenue for the year was $43.5 million versus $17.4 million for 2020, reflecting a strong uptake in extended sales. Research and development expenses for the fourth quarter were $12.6 million versus $7.6 million for the comparable period in 2020, driven primarily by an increase in unallocated expenses, predominantly personnel costs, and increased clinical trial costs associated with the initiation of the U.S.-based Phase I clinical trial of OTX TKI and the initiation of the U.S.-based Phase II clinical trial for OTX TIC. the phase two clinical trials for OTX-CSI and OTX-DED, the ongoing phase one clinical trial of OTX-TKI in Australia, and the ongoing post-approval clinical trial for DexDenta for post-surgical inflammation and pain in pediatric subjects. Overall, R&D expenses for the full year increased $21.4 million to $50.1 million from $28.7 million in 2020, reflecting the trends identified above. Selling and marketing expenses in the quarter were $9.1 million as compared to $6.8 million for the same quarter in 2020, primarily reflecting increased personnel costs associated with an expansion of the field force. Overall, selling and marketing expenses for the full year increased to $35.2 million from $26.6 million in 2020, driven primarily by increased personnel costs and increased spending on consulting, trade shows, and conferences. Finally, general and administrative expenses were $7.5 million for the fourth quarter versus $6.6 million in the comparable quarter of 2020. The increase in expenses stemmed primarily from increased personnel expenses and professional fees. Overall, G&A expenses for the full year increased $9 million to $31.9 million from $22.9 million in 2020, again, reflecting primarily increased personnel and professional fees. With respect to the financial results for the fourth quarter, the company reported a net loss of $3.9 million or a loss of 5 cents per share on a basic basis and a loss of 23 cents per share on a diluted basis for the three months ended December 31, 2021. This compares to a net loss of $85.6 million or a loss of $1.21 per share on a basic and diluted basis for the same period in 2020. Net income in the fourth quarter of 2021 included a $15.9 million non-cash gain in the fair value of the derivative liability associated with our convertible notes. driven by a decrease in the price of our common stock during the quarter. Non-cash charges for stock-based compensation and depreciation and amortization were $4.4 million in the fourth quarter versus $2.8 million for the same quarter in 2020. Overall, the company reported a net loss of $6.6 million or a loss of $0.09 per share on a basic and a loss of $0.98 per share on a diluted basis for the full year ended December 31, 2021 versus the net loss of $155.6 million or a loss of $2.56 per share on both a basic and diluted basis in 2020. As of February 24, 2022, the company had 76.8 million shares outstanding. As of December 31, 2021, The company has $164.2 million in cash and cash equivalents versus $179.3 million at September 30, 2021. Based on our current plans and related estimates of anticipated cash inflows from Dexcenta and anticipated cash outflows from operating expenses, the company believes that existing cash and cash equivalents as of December 31, 2021 are 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, expenses, and reimbursement associated with Xtenda, and the pace of research and clinical development programs, among other aspects of the business. This concludes my comments on our fourth quarter of 2021 and year-end financial results, and I would like to turn the call back to Anthony for some final thoughts.
spk05: Thanks, Donald. So before opening the call up for questions, let me do a quick summary. The company demonstrated solid performance, growing total net revenue 66% over the comparable quarter of 2020 and approximately 150% in 2021 on a full year basis. With FDA's approval of our SNDA to include ocular itching associated with allergic conjunctivitis in the dexamethyl label, we are establishing a separate commercial business unit consisting of key account managers and field reimbursement managers to focus exclusively on the office setting while the main sales team continues to focus on maximizing the opportunity for dexamethyl in the surgical setting. With the recent OPPS final rules, CMS has laid out a path for the continued separate payment for Dextenza in the ASC environment after the path through expiration. This could allow us to maintain and strengthen our surgical business as we build a new source of growth in the office environment. The US-based trial of OTX TKI evaluating a single 600-microgram implant versus anti-VEGF injection versus standard of care every eight-week ILEA is now fully enrolled, and we expect to announce interim data in the second half of 2022. We recently initiated our phase two clinical trial, OTXTIC for the treatment of glaucoma and are actively screening subjects. In dry eye disease, we remain dedicated to developing this key market and we've been conducting work to find the best formulations and vehicle control to use as we look to advance both OTXDSI and OTXDED. And finally, the company entered the quarter with 164.2 million in cash on the balance sheet as of December 31st, an expected cash runway through 2023. We look forward to a strong 2022, and with that, I'll turn the call over for questions.
spk00: Thank you. To ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Our first question comes from Joe Cantancaro with Piper Sandler. Your line is open.
spk04: Hey, guys. Thanks so much for taking my questions here, and congrats on the progress. Maybe the first one for me, I had on. and expectations for 2022 and whether you would expect to provide billable unit data on a monthly basis in the absence of any firm revenue guidance and what we should think about as we think about modeling Dextenza, if you could walk through some of the maybe tailwinds and headwinds that we should keep in mind for the year. Thanks, and I have a follow-up.
spk05: Yeah, we have consistently given the monthly in-market insert numbers. I mean, that number is also in the earnings report. So until we start getting guidance going forward, we'll continue to give those numbers. I mean, essentially the real headwind is the questions around the ability of ASCs to be able to staff up appropriately to handle the backlog of cataract surgery's that we understand are very much out there and going to come back into the market at some point. We've mentioned before that we had a really good October and November, really strong uptake in sales, and we saw the slowdown in December that followed the lower than expected number of cataract surgeries due to the Omicron upswing. We saw that continue into January, but we have seen in February a bounce back starting in the market as well. So if we understand that going forward, we're not only going to get a normal flow of cataract volume, but can in fact see that some of those delayed surgeries reenter the market, we're actually looking forward to a very, very good 2022. Once we have some transparency of what that market is going to look like, we'll revisit the idea about giving guidance.
spk04: Okay, got it. Thanks. That's helpful. And then maybe if I could ask someone... to Mike, and I know there was a recent phase three extended VEGF wet AMD study that recently read out, and wondering if you see any learnings there, whether it be on trial design, enrollment criteria, or even how ILEA performs. Any thoughts you had there would be great.
spk03: Thanks, Joe. I think you're talking about the recent Kodiak trial. And I guess the key learning is that getting longer duration therapy with an anti-VEGF monoclonal antibody is challenging and continues to be challenging. And I think if someone can get that to work, then that's a huge opportunity. So I think one of the biggest learnings is, and we've always believed this, that it's really, really tough to get a monoclonal antibody to have an extended duration beyond two or three months. And we're committed. We believe that having a potent small molecule TKI, you know, is a really interesting approach. And based on the data we've already shown from the Australian trial, we really enrolled some of the more challenging patients and were able to show, you know, essentially with monotherapy that we could get rid of fluid and we can maintain that for six or more months. It's super exciting for us. And then we have the U.S. trial now, which is, you know, really enrolling a more similar population to what you see with other U.S. trials where you're coming in with patients who are either getting three injections up front, as they did in the Kodiak trial, or in our case, are coming in pre-treated, and then you're asking the question, can you maintain that? We think that's a much lower bar than we've already shown in the Australian trial.
spk04: Okay, got it. Thanks. That's helpful, and thanks for taking my questions again. Thanks, Joe.
spk03: Thanks, Joe.
spk04: Talk to you later.
spk00: Thank you. Our next question comes from John Wooden with JMP Securities. Your line is open.
spk07: Hey, guys. Thanks for taking the questions, and congrats on the progress. Just wondering for a little more color on the legit conjunctivitis business unit. First, just wanted to confirm whether or not there was any sales in AC in this 12.2 dextensin number for the fourth quarter, and then hoping you could give us a little more color on the size of this business unit. and what your expectations might be for the contribution to the top line in AC this year.
spk05: No, we don't expect there have been many or any AC sales in that 12.3 number that we put in in the last quarter. What we're doing initiating this quarter and we'll start next quarter is a fully dedicated team in the office environment That team initially is going to be very small. So we're talking about five key account managers, probably one dedicated field reimbursement manager, and then a leader of that team. What we would like to do in that environment is to understand what the drivers are in the office environment, how we need to adjust our programs to make sure that they're fit for purpose. And as we start to understand what that opportunity is, we will invest behind that opportunity. So rather than set forth the number that we expect to hit and then resource to hit that number, we've done what we did with the launch of Dextenza, which is get in the market, get to understand what drives the market, and then invest once we have the formula correct. And we're going to do exactly that in the office and optometric environment as well. So there's not really a number that we're chasing, but we're trying to decode the system, and then once we understand it, we will flog it.
spk07: Got it. That's helpful. And just one on OTX TKI. I know you're enrolling a cohort four in Australia. That could be a nice sneak peek of what to expect in the second half of this year from the U.S. study. Given that's open label, will you be releasing any of that data ahead of the U.S. data?
spk03: That's a good question. So we are enrolling a cohort four, which has a single implant, 600 micrograms. You know, as you know, at the endogenesis meeting, we revealed the results from the cohort three, which is the 600 microgram, but it was the three 200 microgram implants to get there. We actually don't think it's going to be meaningfully different. It could be, but we don't think it will be. And, you know, I think if we've got something meaningfully to say in terms of cohort four in Australia, then there is an opportunity to give an update, you know, on the open label trial. As you mentioned, the U.S. trial, because it's a masked trial, we really need to wait the time. Now, we do have the opportunity per protocol to do an interim analysis, which, as I mentioned, we anticipate to do after all or most of the subjects have hit six months or longer, which we think would be a meaningful time to take a look at that.
spk07: Got it. Thanks for taking the questions.
spk00: Thanks, John.
spk03: Thanks.
spk00: Thank you. Our next question comes from Dame Leon with Raymond James. Your line is open.
spk06: Hi. Thank you for taking the questions, and congratulations on the updates and outlook for 2022. Two questions for me, please. Firstly, as you get closer to having that six-month data from the 600-microgram single insert in the U.S. study, what's been the feedback coming out of angiogenesis in terms of where you think the hurdle is clinically for that six-month duration of retreatment, needed retreatment, or standard of care. Is it a percentage of patients? Is it defined by the type of patient and the prior treatment history? Because that's been one of the major points of debate. So any thoughts there would be appreciated. And then secondly, it does seem like you're trying to – rework the dry eye program a bit, both with the cyclosporine and low-dose dex. Is there kind of a timeline where you think you might be able to re-engage some Phase II studies with that program? Thank you.
spk03: Thanks, Dane. Good questions, as always. In terms of OTX TKI, I think it's a – so I think the number is really a tradeoff, depending on the safety signal you're seeing. And given that to date we've been pleased with the strong safety signal we've shown with OTX TKI, we think something around 50% of subjects getting to six months or longer is a reasonable clinical target. Now if you look at our 600 microgram data from cohort three, we actually were up around 80% of subjects. So if we can replicate that in the US trial or something like that, we'd be really happy. And again, just to point out what I've said before, the Australian trial started with patients who had a lot of fluid, and we were trying to get rid of that fluid with the TKI. That's something that no one else has done that we know of, and no one else continues to show. So we think that's a much higher bar, and we've actually been able to show some subjects where the fluid's gone away completely, and we've maintained that out to six months or longer. The U.S. trial, more similar to what others are doing, You know, in other cases where people have gotten loading doses and seeing if you can maintain people in that dry state for a longer period of time. So, you know, frankly, we'd be pretty disappointed if we don't hit, you know, 60% or higher when we go to the 600 microgram single implant in the U.S. trial. But we will, I guess we'll find out in the near future. Sure. But I think if we hit that target, that's a blockbuster given the safety profile. And if we had a lot of inflammation, if you had a lot of endophthalmitis, if you had vasculitis, the equation changes. But assuming you have a strong safety profile, we think being north of 50% is a very compelling potential option. The other point I should make, and not to be lost here, is that the implants go away completely without the need for removal. So one of the concerns that people have with long-duration therapy is is that they can hang around for a long period of time. And, you know, that's something, you know, we've shown that consistently across all our programs is that the hydrogel goes away in a consistent pattern, and we've seen that with TKI. So if you have something that's safe and you know it's going to go away, it gives you a lot of leeway in terms of the efficacy side of things. To answer your dry eye questions... So they're a little bit different, but a little bit similar. So both the DED and the CSI showed some interesting information that we showed from the Phase II trials. I think in both cases, there's some reworking that needs to be done, some very mild formulation tweaks in DED, some larger formulation tweaks with CSI. But the real work for both of those is thinking about the comparator And what we know is that you can't use a sham as the comparator, but there are different options in terms of the hydrogel that we use, and there's some work that needs to be done to optimize the comparator. Because from a regulatory perspective, it's really about the separation between the active and the comparator. So those are plans that are on the way. We're committed to revealing what that plan will look like sometime in the second quarter. But, you know, we wouldn't anticipate phase two trials starting in either program any time in the real near future.
spk05: I mean, Dan, thanks for your point on that. I mean, the one thing we understand in this area is that these trials in dry eye particularly are very high-risk trials. And what we want to make sure is that we thoroughly mine the data that we have from our phase two and also understand the process by which we can scale up on both the vehicle and the active drug sites with an eye toward the preservation of our cash runway. So there are ways that we could always bring that forward, which would obviously increase the risk of those trials. What we'd rather do is we'd rather do it absolutely the right way and make sure that we have the appropriate vehicle and we have the appropriate actives in both CSI and DED and start trials that we have full confidence are going to be able to yield results that can lead to registrable products. So we could go one of two ways. We could either go very, very short term and get into the clinic as quickly as possible, or we could take a longer road and lower risk with lower cash burn. We are definitely leaning toward the lower risk and lower cash burn side.
spk07: Thank you.
spk00: Thank you. And our next question comes from Yi Chen with HC Wainwright. Your line is open.
spk01: Thank you for taking my questions. First question is, regarding the new sales unit for the office setting used after Extensa, are those people new hires or they are existing reps and they're just being allocated to the new team?
spk05: They will likely be a mix. We don't have the team in place yet, but what we've done is we've opened up vacancies that the surgical team is allowed to apply for. My guess is in the end it will turn out to be a mix of new hires and existing people within the surgical team.
spk01: Okay. Okay. So do you expect the company to start recognizing revenue from Dextenza for AC in the current quarter or the second quarter?
spk05: I think it will ramp slowly in the second quarter. And once we crack the code about the proper way to sell Dextenza in the office environment, We will layer on resources as needed, and I would expect in the latter part of the year and certainly in the beginning of 2023 to really start to see the ramp up in that office environment. I mean, assuming there's a there there, because once again, we're starting with a small team that's trying to look for the pressure points in that environment. We believe that it's there. There's a tremendous reservoir of unsatisfied patients. And there's a great need in the office environment for a buy-and-bill product for the front of the eye that has a procedure code attached. So the ingredients are right. We just need to figure out what the right alchemy is.
spk01: Okay. And for the wet AMD indication, for those patients who do not respond well to anti-VEGF therapy, do you think there's a chance they can possibly respond to LTX TKI?
spk03: compared with currently available anti-VEGF drugs. So it is certainly possible that those patients who don't respond well to anti-VEGF drugs will respond well to TKIs. That said, you know, the U.S. trial is enrolling patients who are responding well to anti-VEGF drugs, so we're not selecting for those patients who don't respond well. The Australian trial is a bit of a mix. And, you know, we've got some patients who are naive, some who responded well to anti-VEGF, and some who didn't have great responses to anti-VEGF.
spk01: Got it. And for the glaucoma trial, do you still expect the trial to complete enrollment in the second half of this year?
spk03: So we haven't given guidance. on when we expect enrollment to finish. I think it's, you know, about 105 patients over. So finishing this year I think would be an aggressive target. I think we'll see how enrollment goes, and as we go we'll give an update at some point with appropriate guidance. But I think it would be unrealistic to expect enrollment to fully enroll this year.
spk01: Okay. Thank you.
spk07: Thank you. Thank you.
spk00: Thank you. As a reminder, if you would like to ask a question, press the star, then one key on your touchtone telephone. Our next question comes from Anita Duyanis with Berenberg Capital. Your line is open.
spk08: Hi. Good afternoon. Thanks for taking my question, and congrats on the progress. Just two for me here. I know you spoke about the next steps in the DED and CSI candidates. Could you please talk about maybe the timelines associated with the development, especially now that you are working internally to develop a comparator?
spk03: Yeah, so as I mentioned, we will develop the appropriate we'll reveal the appropriate clinical regulatory and manufacturing plans in the second quarter of this year. And so that'll be the time we'll give an update on guidance. But we don't anticipate starting a phase two trial in either program in the near future for the reasons Anthony mentioned previously.
spk08: Okay, thank you. And then what are some of the metrics that... you probably look at in terms of the backlog that will be addressed with the surgical procedures that will use Dexenza?
spk05: Well, the metrics are essentially that there's usually in a normal year around 4 million cataract surgeries that are done in the United States. We believe that in 2021, that number was closer to 3 million. Because cataracts don't spontaneously resolve and you at some point are going to need to get the cataract done, the assumption is that those million or so cataracts that weren't done in 2021 will sprinkle themselves in the latter half of 2022 and early 2023. So just giving rough numbers, you would expect four and a half million this year and probably another four and a half or more million next year. which would give us a really nice bump on a basis of what we saw in 2021. Okay, thank you.
spk08: That was helpful. And then the last question is, are there any updates from the collaboration with Mosaic Biosciences?
spk03: That's a good question. So that collaboration is to develop a longer-duration drug in the dry AMD space, and it's going extremely well. And it's on target, and we hope to develop a new candidate at some point in the near future.
spk08: Okay. Okay, thank you for that.
spk05: Thanks for the question.
spk00: Thank you. And that's all the questions we have. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.
spk05: Thank you.
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