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spk04: Welcome to the Gloucester Corporation Third Quarter 2022 Financial Results Conference Call. Copies of today's press release and quarterly summary document, both issued after the market closed today at www.gloucester.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer section. Please, if you would like to ask a question, simply press star and then the number one on your telephone keypad. If you would like to withdraw your question, again, press star and then the number one on your telephone keypad. This call is being recorded and an archived replay will be available online in the Investors Relations section at www.glowcoast.com. I will turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.
spk09: Thank you and good afternoon. Joining me today are Glacos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman. Similar to last quarter, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter, the state of the company's business objectives and strategies, and any forward statements or guidance we may make. This document has been and will continue to be provided alongside the company's earnings press release and is designed to be read by investors before the regularly scheduled quarterly conference call. As such, for this call, we will make brief prepared remarks and quickly transition into a question and answer session. It is our goal that this format will make our quarterly earnings process more efficient and impactful for the investment community going forward. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, sales, products, pipeline technologies, our US and international commercialization, integration, and market development efforts, the efficacy of our current and future products, our competitive market position, our regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of the COVID-19 pandemic on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, it may cause our actual results to differ materially from those expressed or implied by forward-looking statements. We reviewed today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor section of our website at www.glaucos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaucos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and our earnings press release available in the investor relations section of our website for a reconciliation of these measures to the most directly comparable GAAP financial measure. With that, I will turn the call over to Glockos Chairman and CEO, Tom Burns.
spk00: Okay, thank you, Chris. Good afternoon, and thank you all for joining us today. Today, Glockos reported third quarter net sales of approximately 71.3 million, down 1.6% year over year, on a constant currency basis. I'm pleased with our team's ongoing commitment to advance our key strategic priorities and execute our plans while navigating a challenging macroeconomic environment. As a result, we are updating our 2022 net sales guidance range to $278 million to $280 million versus $275 to $280 million previously. From a commercial perspective, we continue to be encouraged with the execution of our strategies and the resiliency of our US combo cataract franchise in the face of the reimbursement headwinds thus far in 2022. At the same time, we remain focused on innovating and expanding the site-saving tools available to surgeons to improve overall care for ophthalmic patients. Over the course of this year, we have continued to successfully expand our comprehensive, best-in-class product offering for our customers with the introduction of several novel ophthalmic technologies, including iAccess, a novel instrument with features that allow customers to perform goniotomy procedures, and iPrime, an innovative new viscoelastic delivery device. More recently, in the fourth quarter, we commenced U.S. initial commercial launch activities for iStent Infinite, our novel three-stent injectable system designed to provide foundational 24-7 ILP control for glaucoma patients uncontrolled by prior medical and surgical therapy. While this launch remains in its infancy, it represents a significant milestone for glucose and the makes market as the first ever microinvasive implantable device indicated for use as a standalone glaucoma treatment. We believe iSent Infinite will spearhead our long-held mission to create a new interventional glaucoma marketplace that seeks an alternative treatment paradigm to topical medications to advance patient care and to halt the progression of this chronic, sight-threatening disease. We are bullish on iStent Infinite's long-term prospects, but would caution conservatism as you think about near-term contributions as we navigate the ordinary course and process of securing professional fee coverage and payment from the various MACs through the first half of 2023. Our international glaucoma franchise once again delivered strong operational year-over-year growth of 24% on a constant currency basis as we execute our strategies to drive deeper penetration and broader adoption of MIGs around the globe. On a reported basis, international glaucoma sales grew 9% year-over-year in the face of continued significant and growing foreign currency exchange headwinds. And within our corneal health franchise, we are pleased to deliver a quarterly record for overall sales of 17.5 million and U.S. vitrexia sales of 14.4 million. Vitrexia sales grew 12% year over year as we continue to focus on access for keratoconus patients suffering from this rare disease. While it remains early, we've been pleased with initial signs of improvement following the investments we've been making to address sporadic reimbursement issues. Speaking of investments, let's shift gears to the development front where we continue to advance our deep pipeline. During the third quarter, we were delighted to announce positive top line data for both phase three pivotal trials of high dose TR that successfully achieved the pre-specified primary efficacy endpoints through three months and demonstrated excellent tolerability and a favorable safety profile through 12 months. The powerful Phase III results also demonstrated that 93% of slow-release, high-dose TR subjects remain well-controlled at 12 months, an encouraging trend that is further supported by the three-year results observed in our Phase IIb clinical study, in which 73% of patients remain well-controlled on a single injection of high-dose TR using the same or fewer baseline medications. These results mark a major milestone for our company and powerfully reaffirm our view that IDOS-TR can be a transformative, novel technology able to fundamentally improve the glaucoma treatment paradigm for patients. Our clinical and regulatory teams are hard at work preparing an NDA submission for IDOS-TR, and we continue to target FDA approval by the end of 2023. As for Epioxa, our Epion, our next-generation corneal cross-linking therapy for the treatment of keratoconus, following our recent pre-NDA meeting with the FDA, the agency has recommended that we run a second confirmatory pivotal trial to support an NDA submission. The agency did confirm that the completed Phase III study, which met the pre-specified primary efficacy endpoint, would support submission and be accepted for review of an NDA in conjunction with the second study. Our understanding is that the FDA's request for a second study, which was unexpected to us, was driven by earlier stage clinical studies associated with other companies' unproven therapies that generated less than favorable efficacy data. In response, we plan to commence patient enrollment for the second Phase III confirmatory study by early 2023, with targeted enrollment completion by the end of next year. Despite this delay to our previous timelines for Epioxa, we believe we remain well-positioned with our first-generation corneal cross-linking therapy for Trexa or Epioff, which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus. We are now in the midst of several new product launches and are planning for a robust cadence of new droplets platform and product introductions over the coming years that have the potential to fundamentally transform Glaucus over time and meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening diseases. While we continue to monitor and feel the impact from extraordinary inflationary pressures and foreign currency exchange headwinds, we believe we are well-positioned with an increasingly diversified business and strong balance sheet to successfully navigate these and other potential macroeconomic uncertainties as we continue to deliver on our near-term objectives while advancing our longer-term mission to transform vision. We are and remain excited about our prospects and are confident in our ability to execute our plans in the years to come. So with that, I'll open the call to questions. Operator.
spk04: Our first question comes from David Saxon from Needham and Company.
spk02: Yeah, hi. Good afternoon, and thanks for taking the questions. Maybe just start just on the guidance and the quarter. I mean, you beat by 3 million, and it seems like a lot of the strength, at least relative to my model, came from U.S. glaucoma, despite the reimbursement dynamics. But you only took the guide up by... by 3 million at the low end. So just wanted to ask, you know, are there any new challenges you're facing? Maybe ice tank cannibalization from, you know, I-prime or I-axis, or are there any other headwinds that are just becoming more severe, you know, that's preventing you from raising the top end? And I guess related to that, how should we think about, you know, trends as we go into 23?
spk11: Okay, thanks, David. It's Joe here. I'll cover most of that, and if Tom wants to add some color, he can. I think totally fair perspectives with respect to guidance. What I'll say is, you know, we've been really pleased with our performance through the first three quarters of this year and proud of our team that's executed incredibly well, as you noted, in the face of the CMS headwinds here in the U.S. and really competition globally. You know, what I can say is our U.S. Glaucoma franchise is has really remained quite stable with very little fluctuation in our daily sales from really July all the way through October here sitting here today. And really the biggest driver at this moment, which probably doesn't come as a huge surprise, is currency when you're thinking about the remainder of the year. You know, we took a look back and we estimate that FX will probably cost us between $8 and $9 million of revenues in 2022 when it's all said and done. And And that suggests, you know, we would have been nearing almost $290 million in sales this year, XFX, which is pretty impressive when you consider all that we face coming into the year. As it relates to the fourth quarter of that impact, we estimate somewhere in the neighborhood of $3 to $3.5 million of headwind in the fourth quarter related to currency, which is another big step in the wrong direction sequentially. And then beyond currency, really, it's a mix of smaller items, which, you know, include perhaps less contribution from iPrime given ongoing supply chain challenges there and and infinite as the MAC calendar to turn on coverage is effectively closed for the remainder of the year. And then the list of things that you're probably used to hearing in terms of macroeconomic stuff that staffing constraints and COVID variants, resurgence, all things that we're certainly not immune to. But, you know, big picture, I think we enter the quarter with quite a bit of stability with the exception of one thing we can't control, which is foreign currency.
spk02: Okay. That's helpful. And then I wanted to ask on IDOS, you know, you're nearing NDA submission. Maybe can you put a finer point on, you know, when specifically you expect to, you know, have that in? And then, you know, I get asked a lot about the margin profile of that. I know it's an unknown just given that we don't know what the pricing could be like. So maybe can you talk about, you know, what the COGS profile would be relative to the iStent COGS? Is it kind of in line? Or are there any aspects that would make it materially higher? Thanks for taking the questions.
spk00: Yeah, David, I'd be happy to address the first part of your question, which talks about our preparation for an NDA submission for Eidos. And really, we're on track. So we've talked about having it at the tail end of this year into early next year. And it appears we'll be filing for that NDA in early part of next year. That puts us in a great position. with a PDUFA filing of typically 10 months from the time we file to achieve our objective, our long-standing objective of have approval of Eidos by 2023. So I probably won't get into the cogs and the issues of pricing. I've been resistant to do that for obvious reasons and competitive reasons, but I will assure the community of investors on the line that we're in a great position with a novel product that really creates an arc of innovation and the first truly long-standing sustained treatment for glaucoma. And in this case, a highly respected company by me, Allergan, has set a predicate price of around $2,000 to $2,100 for a therapy that's approximately the last four months. And so any way you computute the order of magnitude difference in our sustained release over that predicate implant gives us a lot of room to be able to fairly price this product in the marketplace. And you can imagine the margins will follow. And so I'll just say that. We expect healthy margins. We expect a healthy position as we move forward. And more importantly, we expect a highly innovative product that is going to transform the treatment of glaucoma for patients and for this company as well.
spk04: Our next question comes from Ryan Zimmerman with BTIG.
spk13: Hi, guys. This is Sam on for Ryan, and thank you for taking my question. Given the changes to canaloplasty reimbursement proposed and finalized for 2023, how do you expect this to shape physician behavior in terms of product usage?
spk12: And then I have a follow-up, too.
spk11: Thanks, Sam. It's Joe. Yeah, I think there's been a lot of moving parts, obviously, over the last 12 to 18 months as it relates to reimbursement issues. Another one that, you know, on the margin, obviously, net-net probably helps the other categories around it, but certainly is relevant when we think about, you know, our own product, iPrime, and launching that more fulsomely in 2023. So, you know, we never welcome adjustments downward as it relates to reimbursement, regardless of the category. But in this case, clearly, you know, it's a fairly sizable adjustment and something that I think, you know, all... accounts and practices will take into consideration.
spk12: Thank you, Dan. Another question I have is, with your growing portfolio of products in the U.S. glaucoma franchise, how will this impact forward margins as price varies among the products?
spk11: I think in general what we've said for a while is that the totality of our product portfolio shouldn't significantly alter our margin profile. I don't know if, Alex, you want to add anything to that?
spk01: I was just going to say, Sam, that's exactly right. We continue to target, as we've seen historically, that 83%, 84% range, and nothing in our portfolio would lead us to change that answer at this point.
spk05: Our next question comes from Tom Steffen with Stifel.
spk07: Great. Hey, everyone. Thanks for the questions. I'll start with 2023. I think street consensus sales points to roughly, I think, 12 to 13 percent year over year growth. Not going to ask for guidance, but, you know, can you guys help us with sort of the key fundamental puts and takes that we should be mindful of maybe in each of your three segments sort of as we head into next year?
spk11: Yeah, Tom, I'm happy to do that. It's Joe. Obviously, as you noted, we typically provide guidance on our fourth quarter call, and as of now, we'd expect to do that the same way for this cycle. As far as puts and takes, and maybe actually I'll start off with a slightly different variation, which is what may be an obvious statement for most, but I want to make sure that street models kind of reflect the following as folks dial them in for 2023, even in advance of guidance, right? The first and most prominent, which is what I mentioned earlier, is that the current FX environment is reflected. Obviously, as we continue to see the Fed make moves and the dollar strengthen, we're not immune to the impact of that. As you saw in this most recent quarter, we had operational growth internationally of 24%, and that translated only into 9% reported growth, given significant FX headwinds that were actually growing as they entered the fourth quarter. So as we sit here today, I think that, you know, we have to take a fresh look at what all that means in terms of the environment heading into 2023. Again, nothing we can control on that front, but something that all companies are facing. The second one is, you know, I think there are some or there's been varying degrees of Eidos inclusion in the revenues for 2023. You know, you just heard Tom talk about, you know, the timeline, which is unchanged and has been that way for some time, where we're targeting an approval of late 2023. I think it's unrealistic to expect a contribution from Eidos in 2023 revenues, or certainly not that we would guide to come the call, the fourth quarter call in early 2023. And the third thing I'll mention is Einstein Infinite. Given, as we've talked about for a while, the six to nine month MAC process for establishing coverage, the pro-fee, et cetera, I think that people need to be thoughtful about the way they integrate that in their 2023 models and and understand it'll be a more meaningful contributor in the second half of 23 versus the full year. Aside from that, I think the puts and takes are around the sort of core combo cataract franchise, how you think about that from a stinting and a stint I-prime perspective, I-access perspective. And then on the corniest side, it's more about blocking and tackling and hopefully continued progress that we're making
spk07: in um in dampening the noise around some of the commercial payer dynamics that we talked about in the last couple of calls got it thanks Joe that's that's great color um and if I can switch to idos um I guess up until you know I think you guys are targeting full data publication of the phase three sort of at the time of I believe approval uh you were hoping but Can we expect any updates in the form of additional top line sort of data along the way? And then what about the strategy ahead of potential launch, just from an operational perspective? I'm curious if you guys can give us a flavor for any initiatives sort of ahead of the potential launch. Thank you.
spk00: Yeah, I'd be happy to address that. So as I've said before, I think it best serves the company to have really a strong peer review data set that will come out in or around the time of launch. And so we'll be publishing a full data series set of our Phase 2b data and our Phase 3 data. I want to see those in combination. I want to see them hit again sometime around the time of our launch. This is a strategy I think will serve us well. And again, I think it's important we reserve that for the time when it's going to have the biggest commercial impact. and not give, by introducing it too early, our competitors several months to counter detail where we don't have a field force active to be able to counter maybe some of the information that won't be construed the appropriate way. So it's the right thing to do. It will be deep. It will be thorough. It will be compelling. And it will be coordinated with our launch. Now, we clearly, as we go forward, There'll be several conferences and there may be opportunities where it will benefit the company and investors to see a little bit deeper into the data. I'm not opposed to that, quite open, and we'll look for the right opportunities and the right data to share. What I do like is that I believe I've given the investors really powerful indices and responder analysis, which to me are the most important criteria upon which to value this product. showing that 93% of patients at one year are well controlled on this new device. 81% are well controlled on no medications. And if you think about that, over 20% of patients in the entry criteria were on two or more medications. And so this, to me, is exciting data. It's extraordinary. It's definitely beyond what we were anticipating in the marketplace. And again, we have the Phase 2b data out of three years, which we will use to our advantage with payers to be able to assure that we get appropriate coverage and payment, both with MAX and at the commercial level.
spk05: Our next question comes from Margaret Kaxer with William Blair.
spk03: Hey, guys. This is Mike on for Margaret today. Thanks for taking the question. So I just wanted to ask a quick one on the core iStent franchise. I just wanted to ask, what do you guys see as far as resiliency of the franchise right now and maybe with some of the competitive trialing and reimbursement changes? What are your thoughts on market positioning right now and can you return to growth with that core franchise in 2023?
spk11: Thanks, Mike. Yeah, I mean, as I mentioned a bit earlier, I think, you know, the right way to characterize it, the stint business, the U.S. glaucoma franchise overall has been incredibly stable, really, over the course of the year and certainly exceeded our expectations coming into it in the face of the CMS, you know, cuts on the pro fee. And even so much as in recent months, the last three or four months, July through October, we've continued to see that stability. I think that sets up a nice base as we exit 2022 and enter into 2023. Certainly, we're not going to face the same type of changing environment as we turn the corner this year as we did last. But I'll stop short of commenting on that in the context of whether that will precisely deliver what amount of growth and the like. I think you have to think about it in totality. And both in the combo cataract segment, where we've got the core stents, but also increasingly, hopefully, I-prime, as well as I-access, and Iceland Infinite driving those results, both in combo cataract and standalone. There's a lot of opportunity there for us, but we've got a lot of execution, both on the reimbursement side, as well as on the field side, to ultimately deliver in 2023.
spk03: Got it. And then just wanted to ask on Iolution, just as a quick update, are you guys still expecting to share that phase two data in early 2023, and then maybe on the presbyopia side specifically, what can you tell us on market receptivity for similar products in the past, and how can this compete versus others in the presbyopia market?
spk00: Okay, well, let me give you an update, first of all, on Ilusion. So as you know, we've been running two parallel trials in dry eye. and in presbyopia using different concentrations than a normal phase two study. And I'm really pleased to say we've completed the enrollment for both of those studies. In fact, with dry eye, we've actually cleaned, locked the data in, and we're in the process of assessing that data as we speak. And in the case of presbyopia, we've completed the trial and we're currently cleaning the data. Why this is important is because if you looked at the clinicaltrials.gov, we gave ourselves some headroom, but we said we would have really data available by or the clinicals done by May of 2023. So we've significantly overachieved there. So to answer your question, we have the data, and I would expect that in the early part of 2023, we'll be in a position to be able to share that with you. Presbyopia is a market we continue to look at, and we're monitoring Vuiti very, very clearly and very specifically. And I think their performance will lead us to determine how we look at and how we assess the data that comes out of our trial and how it will be viewed both from a safety and efficacy standpoint versus Vuiti to give us the ability to move forward. with confidence that we'll have a product that we can show has significant safety and efficacy advantages.
spk05: Our next question comes from Larry Beagleson with Wells Fargo.
spk15: Hi, this is Charles on for Larry. Got a couple more on iDose. I mean, the early data you shared looks promising, but we obviously haven't seen it all. Can you talk a little bit about the occurrence of some of the less frequent adverse events in the phase three studies, like endophthalmitis, cataract formation, or lack of anchoring, and if any of those could be an issue from a regulatory standpoint? And then I've got a couple follow-ups.
spk00: Yeah, I'm happy to do that, and I appreciate the question, Charles. I mean, the data is prolific. from a safety standpoint, from any objective measure. When we looked at the Phase III data, we had a 3% rate of hyperemia versus rates that you see with topical prostaglandins on the order of 30% to 50%, and with more recent products that have been introduced with rates that exceed 50% rates of hyperemia. We had zero cases of periorbital fat atrophy in this study, which has been kind of a headwind to the use of these prostaglandin analogs, which leads to these shallow lower lids. We've had a superlative record on the issue of endothelial cell counts. That's been shown in our phase 2b data where we followed these patients for three years, and we found no clinical variation between the treatment and control. In fact, they were virtually nearly identical in terms of how we assess the two treatment patterns of endothelial cell counts. We are seeing, to my knowledge, no SAEs within the pivotal trial of the phase three data. So you're going to see data that not only is compelling from an efficacy standpoint, but from a safety standpoint is going to grant clinicians the assurance that they should be looking at entering earlier in order to treat patients who are progressing despite the fact that they're on topical therapies.
spk15: Thank you. And then just a quick follow-up on the IDOS label. First, what are your expectations for the IDOS label in terms of duration and repeat usage? And do you think combo cataract will be on or off label?
spk12: And is there any economic barriers to adoption in that setting?
spk00: Yeah, so I really appreciate that question because it's good we have the opportunity to say with certainty what we're seeking. We're seeking under a 505B2 designation a very broad and highly favorable label. And the label we seek is for the reduction of intraocular pressure in patients with open angle glaucoma or OHT or ocular hypertension. This is a profoundly broad label and the label is undefined by the sustained course of therapy. So that's important. So we're not seeking to be able to pinpoint a time during the label of how long or how long this lasts. That, in a sense, has already been assessed and demonstrated. With respect to length of therapy, we already have conducted this robust phase 2B clinical study, which demonstrated that 73% of patients were well-controlled on IDOS therapy using the same or fewer medications at three years. So this study, when published along with our phase three pivotal data, I think will be the basis for primary justification for coverage and payment by ophthalmologists of the sustained drug efficacy or by ophthalmologists and the sustained drug efficacy performance of the IDOS implant. So that answers the first part of your question. The second part is we were, I think, both prescient in negotiating with the FDA to do a small exchange study. as part of our phase, looking at phase 2B patients that we were able to call, and we've been able to do an exchange study to demonstrate the safety and effectiveness and the ability to retreat these patients using I-dose implants. So I can't say with certainty because we're still in the process of unmasking the data, but I can tell you that we will submit this data part of our NDA submission, and our target is to have the full wherewithal to be able to to be able to use the Eidos implants and to exchange them once they're depleted of their medication so that we'll have an ongoing annuity with the process.
spk05: Our next question comes from George Sellers with Steffens, Inc.
spk08: Congrats on the quarter and thank you all for taking the question. I guess I wanted to just start by asking about the launches of the iAccess, iPrime, and iStent Infinite devices. How are those launches progressing in terms of physician adoption and traction you're seeing in the market? And also, are there any additional hurdles, such as in relation to reimbursement, for instance, that we should keep in mind?
spk11: Thanks, George, and welcome to the call and your new role. This is Joe. Let me start off with... with Eye Access. So Eye Access, as you know, we launched earlier this year. From that standpoint, I think everything is pretty clear in terms of its utilization and how it's reimbursed based upon the procedures that the surgeons utilize with it. And from that standpoint, it continues to sort of be one of the tools and toolkit for our sales force going forward. It has been a nice and consistent contributor to our results, certainly in the second and the third quarter, and we expect that as we move forward here. On I-prime, it's still early. I'd say as it relates to I-prime, very little contribution in the third quarter, minimal contribution, and we'd expect a relatively minimal contribution here in the fourth quarter as we continue to iron out some of the supply chain challenges that we've faced over the course of the year in trying to stand this product up. less about sort of the broader market dynamics or macro dynamics, more about supply chain there. We'll get through that, and ultimately we hope that that will be a meaningful contributor to 2023 as we move forward. On Iced and Infinite, as you know, we most recently received clearance there. We have initiated beta launch activities as a part of that approval or clearance, and really reimbursement plays a key role here. As I mentioned earlier, you know, we've got to get through the sort of six- to nine-month process that is navigating the MACs to turn on coverage and establish the pro fees. And so we're in the middle of that process now. We've got our peer-reviewed publication behind us, and our teams are working closely with the MACs to establish that over the course of the first half of 2023. At the point where we've got those all established, you know, we would expect to start being able to drive more meaningful contribution from ICE and Infinite really the second half of 23 and going forward from there.
spk08: Okay, thank you. That's helpful. And then on EpiOn, could you just give us some additional color on why the FDA is suggesting a second confirmatory study? And I apologize if I missed this, but how should we think about the updated timeline for FDA submission and approval there? And how should we also think about the cadence for any incremental costs associated with with this second study? Thank you.
spk00: Yeah, great question. And this is Tom. I'm happy to address. And so during a very recent pre-NDA meeting with the FDA, the FDA communicated that due to what I'll call the uncompelling efficacy results for companies who are practicing epion-like procedures, they would now request that we conduct a confirmatory phase three pivotal trial for our epioxid drug and iLink procedure. Now, it's important to note that our Epion procedure is very different from those that the FDA cites because our procedure includes a continuous perfusion of oxygen across the cornea during the procedure, which yields greater production of oxygen-free radicals and thus stromal penetration. And that results in more extensive cross-linking and leads invariably to the efficacy results that we demonstrated in our Phase III pivotal study. So nevertheless, the FDA subsequently held firm to the position of requiring the second phase three trial, but they did agree that our completed phase three clinical study, which meant the pre-specified primary efficacy endpoint, would be accepted. So that's powerful as one of the two validating pivotal studies supporting our upcoming NDA submission. And clearly, we continue to build the business on the excellent safety and efficacy results of our Fortrexla product, And our Epioff clinical design, which I'll just remind the community, is the only FDA-approved cross-linking procedure that's available today. So with respect to cost, I guess I'll ask my colleague Alex to weigh in.
spk01: Yeah. Hey, George. The way to think about the cost is that we will build the cost of that second trial into our normal R&D operating expense spend and cadence, and it will be absorbed and it's not going to stick out or be increased over what we normally would spend as we move forward through those periods.
spk00: I'll make one final comment. Since I've made this decision to basically move forward with the second study, we're moving extremely quickly, and we may be able to open up a clinical trial as early as January, coming up in the next couple months, fully fully qualified investigators ready to go. And if you think about then the time course for this, given the fact that we should recruit in an expedited fashion, we'll probably be targeting a new FDA approval in or around late 2025.
spk04: Our next question comes from Matthew O'Brien with Piper Sandler.
spk14: Hey, this is Phil on for Matt. Thanks for taking the question and congrats on the great quarter. I guess just for starters, in terms of OpEx, I know you've discussed in the past being, you know, a 300 to maybe 310 OpEx company. Do you expect that moving into 2023 here as well? And is that still your expectation? And then how should we think about gross margins in this high inflationary environment? Is that 84% a good run rate moving forward? How should we think about this as we approach 2023 here? Yeah.
spk01: Hey, Phil, this is Alex. Thanks for the question. So on the operating expense, you're right. We talked about that 310 or so range for this year in 2022. One thing I'll point out that maybe wasn't as clear on the last call, is that we had the $10 million licensing payment last quarter that needs to be incorporated into that number because we don't call it out anymore. It's part of our non-GAAP expenses pursuant to the SEC new rules. So you should think about the operating expense levels for 2022 to be kind of coming in in the 315 to 320 range, which includes that $10 million upfront license payment in Q2. As far as the gross margin, oh, well, I guess you'd asked about 2023 really quickly. You should think about probably, you know, some growth in the operating expense profile as we go into 2023, some sort of sequential growth by quarter. You know, as we think about it here, 10% is not an unreasonable way to think about that, but we'll probably be able to give you more color around that in the fourth quarter call when we talk about 2023 in more detail. And then lastly, on the gross margin detail, you're exactly right. That targeted range of 83% to 84% will be also in play and continue on in 2023, and we'll stay that way until we see some sort of trend that would lead us to conclude otherwise.
spk05: That's great. That's it for me. Thanks so much, and congrats on the quarter again.
spk06: Thanks, Bill.
spk04: Our next question comes from Alan Gong with JP Morgan.
spk10: Hey, team. Congrats on the quarter. So I just had a quick one on what you're seeing, you know, so far in the fourth quarter. It clearly seems like you're weathering reimbursement and competitive dynamics pretty well. But when I think about just broader trends around staffing capacity, you know, we've heard from, you know, adjacent spaces that challenges have improved or maybe being a bit more durable than expected. So how does that impact your own business, and is that part of why you are taking a bit of a more conservative route to the guide?
spk11: Yeah, Alan, it's Joe. I think you're spot on on that, right? I mean, entering in and really through the month of October, the U.S. franchise has remained quite stable, and so we've been pleased with that. But as I mentioned earlier, really the big dynamics that we're trying to – the biggest dynamic that we're factoring in is the continued headwinds from foreign currency, right, and what that means in terms of our international business and translating it back to consolidated results. Beyond that, you hit on some of the more macroeconomic dynamics or macro factors, and we're not immune to that, right? So there's certainly risk as some of the COVID variants seem to be a little bit more concerning entering into the winter season here and the resurgence potential around those. staffing constraints. We hear about it almost every time we talk to our customers. They're challenged still with maintaining adequate staff, adequate skilled staff. That impacts us both on the commercial side as well as on the clinical side as we recruit and something that we hope gets behind us as we enter into next year, but certainly it continues to be an ongoing dynamic in 2022. And then beyond that, some of the things that we talked about earlier around I-Prime and And in Iced and Infinite, really getting those launches fully going, which we aren't really including much of in the fourth quarter of 2022.
spk10: Got it. And then just a quick follow-up on IDOS. So Foley got the message that, you know, probably limited revenues in 2023 with an approval late in the year. But when I think about 2024, how quickly can revenues from that turn on? You know, will you have to do a similar amount of work when it comes to reimbursement and negotiating pro fees with MAC? What needs to be done for the J-code and, yeah, just basically how quickly can that ramp once you do get the approval under your belt? Thank you.
spk00: Yeah, this is Tom, and I just set expectations, and I've said so previously. So I think it's fair to say that once we receive the FDA approval, what typically happens is we'll be assigned a miscellaneous J-code, which will allow some traction in the marketplace, but a little more limited. In the meantime, once we get FDA approval, we'll seek a quarterly HCPCS panel and we'll submit for approval at the projected rate that we want to charge for the implant. And then typically what I would expect, it's a one to two quarter, and I would say the two quarter lag to get the final J code approved. When we have that J code finally approved, you can imagine we will have everything fully prepared, locked and loaded and will be able to come out of the gate very, very strong. And so I would see traction really starting, significant traction starting in the second half of the year.
spk05: We have no further questions at this time.
spk04: I will turn the call back over to the company.
spk00: Okay, thanks for all the great questions and thanks to the investors for your time and attention today. We hope everyone's staying safe. And again, always thank you for your continued interest in Glockos.
spk05: Goodbye.
spk04: This concludes the Glockos third quarter 2022 financial results conference call. Thank you for attending today's presentation. You may now disconnect.
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