Welcome to the Glaukos Corporation Fourth Quarter and Full Year 2022 Financial Results Conference Call. Copies of the company's press release and quarterly summary document, both issued after the market close today, are available at www.glaukos.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks will be a question-and-answer session. If you would like to ask a question during this time, you can press star one on your telephone keypad. If you'd like to remove yourself from the queue, you can press star one again. This call is being recorded and an archive replay will be available online at the investor relations section at www.glaucos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead. Thank you, good afternoon. Joining me today are Glaukos Chairman and CEO, Tom Burns, President and COO, Joseph Gilliam, and CFO, Alex Thurman. Similar to prior quarters, 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 is designed to be read by investors before the regularly scheduled earnings call. For this call, we will make brief prepared remarks and transition into a questions and answer session. 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, our sales, products, pipeline technologies, U.S. and international commercialization, integration, and market development efforts, the efficacy of our current and future products, our competitive market position, 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, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release in 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.glaukos.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 Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available in the investor relations section of our website for reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns. Okay. Thank you, Chris. Good afternoon to everyone, and thank you for joining us today. Today, Glaukos reported fourth quarter net sales of approximately $71.2 million and full year 2022 net sales of approximately $283 million. We are also introducing a 2023 net sales guidance range of $290 million-$295 million based on the latest foreign currency exchange rates. Alex will discuss our financial results and outlook in more detail later in the call. Overall, I am proud of our performance this past year as our results exceeded our initial expectations and reflect solid execution across our glaucoma and corneal health franchises in the face of reimbursement headwinds and a challenging macroeconomic environment. I'd like to recognize the continued dedication and resiliency of our teams around the globe who remain steadfastly committed to their work. Take a minute to highlight some of the key accomplishments we achieved in 2022. One, we showcased the resiliency of our U.S. glaucoma combo cataract franchise in the face of significant reimbursement headwinds. Two, we strengthened our core franchises with the U.S. commercial introduction of several novel ophthalmic technologies, including iAccess, iPRIME, and iStent infinite. Three, we continued to grow and expand our international glaucoma and corneal health businesses. Four, we advanced our near-term pipeline, most notably with the positive iDose TR phase III top-line data that will be the basis for an imminent NDA submission. Five, we progressed earlier stage R&D programs with two phase II iLution studies and other preclinical program developments. Finally, we expanded our global operations and infrastructure to support our long-term growth goals with the build-out of our new headquarter campus in Aliso Viejo, our corneal innovation center outside of Boston, and our state-of-the-art hybrid pharmaceutical manufacturing facility based in San Clemente. Our achievements in 2022 leave us excited about our prospects and well-positioned for the next phase of our pioneering journey as we sunset CMS-related combo cataract headwinds and position the portfolio for sustainable top-line growth beginning this year and the years ahead. Alongside our combo cataract efforts, we anticipate advancing iPRIME and iStent infinite, the latter pending the establishment of MAC coverage and payment. In parallel, we are investing in our founding mission at Glaukos, which is to transform glaucoma therapy by driving earlier treatment intervention for glaucoma disease progression, which in turn will greatly increase our stand-alone market opportunity over time. While we are bullish on the long-term prospects for these efforts, we have remained prudent in our initial 2023 guidance as it remains early and revenue contributions in 2023 versus 2024 and beyond remain uncertain. Within our international glaucoma and corneal health franchises, we plan to continue developing these important businesses by driving deeper penetration, adoption, and access for our MIGS and iLink technologies around the globe. While we execute upon these commercial and market development strategies for our core franchises, we also continue to successfully invest in and advance our robust pipeline of novel, promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. Starting with iDose, our clinical and regulatory teams have made great progress preparing our NDA, and we are on track for submission this month. Earlier this year, we were delighted to announce results for the iDose TR exchange trial, which included a second administration of iDose TR and the removal of the original TR implant, with the second iDose TR demonstrating a favorable safety profile over a 12-month evaluation period. Additionally, no subject in the exchange trial exhibited greater than 30% endothelial cell loss over the extended evaluation period of more than five years on average. We look forward to including this data set, which will augment the powerful phase data results in our upcoming NDA to support the safety and tolerability of redosing iDose patients over time. This further adds to our market-leading body of clinical evidence supporting the best-in-class benefit to risk calculus of our micro-invasive technologies over other competitive alternatives. In addition to our NDA preparation for iDose, we are also already well underway with a team of cross-functional leaders across our commercial and market access organization in the preparation and planning of the iDose TR commercial launch targeted for next year. Shifting gears, we also recently announced positive clinical updates for several of our corneal health pipeline programs. First, we commenced subject enrollment in the second phase III confirmatory trial for Epioxa, our next-generation corneal cross-linking therapy for the treatment of keratoconus, and are targeting an enrollment completion by the end of this year. As we advance our clinical plans for Epioxa, we remain well-positioned to serve keratoconus patients with our first-generation corneal cross-linking therapy, Photrexa or Epi-Off, which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus. Second, we announced promising initial results from the first-in-human phase IIa clinical trial for GLK-301, our iLution Dry Eye Disease program. GLK-301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of the signs and symptoms of Dry Eye Disease. Based on these encouraging observations, we are planning to commence a phase IIb trial for GLK-301 later this year. We are also evaluating the phase IIa data for GLK-302, our iLution presbyopia program, while we continue to closely monitor the evolving market conditions associated with available presbyopic therapies. In addition to these pipeline developments, we also anticipate several additional pipeline milestones over the course of 2023, including a now open IND for iLution Travoprost, a first-in-human retinal trial, and an IDE label expansion study for iStent infinite. As you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. In conclusion, our mission at Glaukos is to truly transform vision by pioneering novel dropless platforms that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. Innovation is at the core of everything we do. Our mantra, we'll go first, embodies our commitment and determination to take chances, to push the limits of science, and to disrupt the legacy treatment paradigms in glaucoma, corneal disorders and retinal diseases through our pursuit of game-changing technologies. I believe our foundation has never been stronger and our prospects never quite as promising. I'm confident we have the right people, strategy, infrastructure, pipeline, and balance sheet to execute our plans and deliver on our future aspirations. With that, I'll open the call to Alex to briefly discuss our forward outlook. Thanks, Tom. I'll now make a few comments on the state of our markets and opportunity today and how we believe things are unfolding for 2023. First, our initial 2023 net sales guidance of $290 million-$295 million takes into account the continued estimated impact on U.S. glaucoma volumes related to professional fee reimbursement cuts For combination cataract trabecular bypass surgery versus other more invasive alternatives. While January first marked the anniversary of when these initial cuts became effective, not all physician behavior changed at once. Second, we continue to expect combo cataract to face competition globally. Third, while pricing dynamics remain largely stable across each of our major business areas, as Tom mentioned earlier, our ability to successfully bring to market and commercialize our newer technologies and interventional glaucoma strategy more broadly remain in the early stages, and therefore, we have assumed relatively modest contributions at this point of the year. While we continue to be bullish on our newer technologies and their market opportunities over time, our assumption is for these products contributions to be more weighted towards the second half of the year. With that, I'll open the call to questions. Operator. Thank you. As a reminder, everyone, that is star one on your telephone. We'll take our first question from Ryan Zimmerman with BTIG. Wow, I'm honored to have the first question tonight. Thank you. It's a good thing. Wanna just ask a couple questions, particularly on the guidance. I think the street's gonna be really focused on this coming out of tonight's call. You know, we're looking for something, I think meaningfully ahead of where you guys guided for 2023. I appreciate that not all physician behavior changed, Alex, and I appreciate those comments. You are coming into this year with stable reimbursement dynamics, you know, easy comps from the past year. You know, how I guess two components of this question. How much of the physician customer base do you think you're through in terms of behavior change, right? I mean, how much more pain does the glaucoma market have to go through with these reimbursement cuts in your view? I wanna also hone in on competition because competition's been here for a while, but you know, admittedly, it's obviously gotten more material with the introduction of Hydrus from a major competitive player, you know, with a very large sales force. How much is that weighing on your minds as you're thinking about guidance tonight? Hey, Ryan. It's Joe. Maybe I'll start off there and appreciate the question. I think, you know, you said it, somewhat fairly in that if you look back on 2022, in many ways, as Tom alluded to, it may have been one of our best years, right? You think about the CMS cut, you know, the related headwinds from that, the investor and even really our own expectations entering the year to finish 2022 nearly flat to 2021 on a constant currency basis, really, I think speaks to the strength of our products, you know, our commercial organization and our sales team specifically. As proud as we are of our performance in 2022, it may not come as a significant surprise to you and others that we wanna walk before we run as it relates to setting expectations for 2023, given everything that we faced. As I think about the next layer of kind of your question in the context of the customer base and competitive dynamics. You know, we do expect those CMS cut related headwinds to slow down in the combo cataract setting. You know, obviously, not all physician behavior does change at once. The economic-based selling of those more invasive alternatives isn't necessarily gonna go away. We do expect that to slow considerably. Candidly, you've seen some of that even though in trends that we saw over the course of the second half of last year, where those impacts were stabilized and slowing as we lap that going into 2022. We do expect those to slow. I think as you unpack that further, it's still there. I think the competitive dynamics are intertwined in that. I think it's less about necessarily the Hydrus dynamic that you're describing. That product's been on for a while. We're battling against Hydrus and Alcon every day. We have in the past, we are today. I think it's more about the more economically advantaged procedures that are out there that we've experienced, you know, have a tailwind over the course of 2022 related to CMS cuts and how that will sunset over the course of this year. I think we're trying to take a cautious stance as it relates to that activity as we enter into 2023, even though we have a fair amount of confidence as it relates to how we stand, you know, over the medium and long term. Okay, just wanna ask a follow-up to that and two parts again. One, do you expect then the market to shift to, you know, you're referring to these procedures that are economically advantageous. I assume you're referring to canaloplasty, but do you expect a bigger shift in the market to canaloplasty this year? The second component of my question, I lost my train of thought. Let me start with that, I'll come back, I guess. Ryan, we're not gonna let you go first anymore. You've got two two-part questions to kick us off. I really dropped the ball on the first spot here. No. You know, as it relates to, I think I'll lump it together in the more invasive approach, canaloplasty, goniotomy, et cetera. You know, I think there's two pieces there that I would call. The first one is similar to what I just said. I think it doesn't really matter what that technology is. Obviously, the relative impact in 2023, we expect to be quite a bit less than what we experienced in 2022 as we sunset the sort of initial dynamics associated with the CMS cuts and the economic disparity that resulted as a part of those. The second piece is, even as we're successful ourselves, that being Glaukos in maintaining those customers, potentially with other technologies, right? Whether that be iPRIME or iAccess. They come at obviously a lower price point, as you know. In some respects, you have to factor all those things into when you're thinking about the dynamics as it relates to glaucoma, specifically, entering into 2023. I remembered the second part of my question, so I'm just gonna squeeze it in here, Chris, I apologize. What are the... When you think about, you know, the split between corneal health and glaucoma in terms of your guide. I mean, if I think about corneal health in kind of the low teens or maybe even high single digits growth, it implies glaucoma sales for this year are essentially flat. And we can kind of split hairs as to exactly where that lands, but is that the way you're thinking about the components of growth, you know, from a contribution standpoint amongst your two business segments? Thanks for taking the question. No, thanks, Ryan. I'll save some of the broader color for others, you know, when they ask, but I'll To the point of your question, I'd say we have expectations. A reasonable place to start to estimate the corneal health business is probably for high single-digit type growth. On the international side of glaucoma, we'd expect low double-digit type growth. Obviously you can do the math on what that means for the U.S. glaucoma franchise being, you know, in and around, you know, a flat business of the course of 2023. All right, we'll take our next question from Tom Stephan with Stifel. Great. Hey guys. Thanks for the questions. I think I'll start off with infinite, actually. Tom or Joe, if you can talk a bit about the progress you've made with establishing the MAC pro fees to date and maybe expectations for the remainder of the year. We picked up a bit from some MACs, I think coming in with pretty attractive rates already, but would love your thoughts on, you know, again, how those efforts are progressing and what that could mean for 2023 and maybe even 2024, if we think out a bit. Yeah. Thanks, Tom. It's Joe. I'll start off, and if Tom wants to add some color, he can. I break the Infinite MAC-related conversation down largely to two pieces. The first is just the overall coverage of the procedure. As we've talked about for some time now, that tends to be a six to nine-month process. You know, what I can say there is we're on track thus far, and we're making a lot of progress, but it's still early. As you probably know, there's no statutory timelines, you know, that you can count on there. We're working hard every day to try to deliver those coverage policies as soon as practically possible. I think as it relates to the pro fee component of that specifically, you're right. I think you referenced there's been two, we'll call it early data points, that have been in the $1,000 range for the pro fee. But again, those are early, and they can change over time as you know, whether it's as the coverage policies are opened or ultimately as volumes grow. I think we're encouraged by those early data points, but there's a lot of game to be played there. Great. That's helpful. I think my second one would just be sort of back to guidance. Joe or Alex, how should we be thinking about H1 versus H2 seasonality this year? FX, likely a tailwind, you know, come H2. You have new products with iStent infinite and I think iPRIME being s on that front. You know, in 2019, I calced it, but I think H1 sale were at 48% but in 2021 and 2022 it was close to 50/50. So you know, for the splits as we build our models, do we go back to those 2019-type levels of, you know, maybe a little less seasonality in H1 or is it even more pronounced, where H2 is kinda greater than that, you know, 52%-53% level? Yeah. Thanks, Tom. I think obviously the last couple of years, the normal seasonality trends have been pretty disrupted by COVID and COVID-related, you know, dynamics. As we enter 2023, I would expect and we would expect that we should get back to something a little more normal from an underlying market seasonality perspective. You know, you referenced some of those numbers, but we've said this a lot of times on prior calls. I think typically the market runs something like 22%-23% in the first quarter, 25% in the second and third, and there could be a little variability there, and 27%-28% in the fourth quarter. I think for Glaukos specifically, you know, our product cadence may play a bigger driver for us specifically than just that underlying market seasonality. Quite frankly, if you think about the year, it may amplify that seasonality a little bit, given our expectations for the second half versus the first half with iDose and Infinite in particular. Hey, Tom, I'll address the FX question for you. We've kinda looked at that as well, and we think, again, overall, we think the FX rates will be relatively neutral on our overall sales for the year. However, we do believe there'll be a headwind to us in the first half and a modest tailwind in the second half. Got it. Thanks, Alex. Thanks, Joe. We'll take our next question from Larry Biegelsen with Wells Fargo. Good afternoon. Thanks for taking the question. Just one follow-up on Infinite, which is the two MACs that have come out with physician fees. They've been about $1,000, which is, you know, 2x a cataract procedure. The question is, do you expect that to stick, and do you expect other MACs to pay about the same? Just any update on the iPRIME supply issues, and added one follow-up. Hey, thanks, Larry. I'll start off on that. I don't think I would hazard a specific guess as to where the individual MACs will come out on their pro fees. You know, we've said for some time, obviously, this is a standalone procedure. When you look at the various standalone procedures that are out there, you framed, you know, one end in terms of the cataract surgery, and obviously there are glaucoma surgeries that go even above where we've seen these two early data points come out. So I think there's a lot of room in there for discussion with the MACs. Clearly, you know, we believe that the fair outcome there is towards the higher end of the higher end of that range. I think You asked about iPRIME. You know, we've now been commercial with that product since last May, and we've been working through growing pains and really optimizing our supply chain over time, and that continues. We really like the product as a part of our portfolio and see a growing opportunity with our customers over time. Thanks. For my follow-up, Tom, on iDose. You know, I'm just curious how you think the ramp will compare to, DURYSTA at the same time post-launch. They were approved during COVID. You know, according to AbbVie, they did about $35 million in 2021. Do you think the ramp will be slower or faster? And, any thoughts on how you're thinking about pricing relative to, DURYSTA? Thanks. Yeah, I'd be happy to address that, Larry. I think as I said before, we'll have to go through the normal mechanics of establishing the reimbursement for the product, that means establishing a professional fee under the Category III designation. It'll get assigned an APC. Soon after launch, we'll be filing for a HCPCS code, which normally takes about 6 months. I've said from the beginning that we'll look to the second half of 2024 as kind of where we'll really pick up traction and see this product receive what I believe will be strong adoption. I don't believe I would use DURYSTA as a as a predicate in terms of adoption. I think these are such invariably different products when you look across the board of how they compare, I think in almost every category. I think most objective observers would say that the balance would be tipped to an iDose. I guess that would give you some means of comparison just by that basis. What I would say on the pricing is what I've said all along. In this case, Allergan has done a service to the company by establishing what they believe is a fair price for a four-month bioerodible implant. I think given the fact that you've seen our three-year data, Larry, you amongst others will believe that that would be the absolute floor of what we think we would be able to achieve in our HCPCS code of the marketplace. Again, I caution all investors on doing any kind of proportional analysis with pricing. I can assure you that we're doing multiple pharmacoeconomic studies behind the scenes, including Markov, transitional probability analysis, burden of illness analysis, direct cost analysis, things that we've done before, I think done quite well and will be in quite a prominent position to establish a fair price following the launch of the product. All right. Thank you very much. Our next question comes from George Sellers with Stephens Inc. Hey, thanks for taking the question. I guess maybe to start, there's clearly been some changes in terms of the operating expenses that you maybe are expecting this year with the additional confirmatory study of Epioxa and the associated expenses with iDose. I'm just curious if you could give us some help on maybe the cadence through this year, as you invest ahead of iDose and then also subsequent to that expected approval, the investment required as you start to commercialize that device. You bet, George. Happy to do that. Actually, I'll take the advantage to give you a little more for all the models. If you think about 2023 and what to kind of model and think about in terms of OpEx and kind of the overall P&L. You know, we've already talked about revenues. If you think about our margin, our margin profile should continue in the same 83%-84% range that we've done historically. You should feel confident to continue with that part of the model. For operating expenses, the way I would guide you to think about that is if you take our normalized 2022 operating expenses, which when I say normalized means pull out the $10 million IPR&D, that was kind of the, you know, under the old rules, we would've excluded it anyways. That leaves you with about a $313 million total operating expenses in 2022. Just assume about a 10% growth, and you'll be in the ballpark. Lastly, I'll just mention it right now while I've got you on the phone. If you think about CapEx for next year, you know, we posted $30 million of CapEx in 2022. That number should come in a bit in 2023. It's probably gonna come in around the range of $20 million. That should help you as you model for next year. Okay, very helpful. Thank you for that. Maybe just as a quick follow-up, turning back to the guidance a little bit, is there any additional color you could give us on what that assumes in terms of contribution from the additional devices via iAccess, iPRIME and iStent infinite this year? Yeah. Thanks, George. It's Joe. Yeah, we really haven't gotten that granular with respect to individual product contributions to any one of our franchises, in particular the U.S. glaucoma business. I think it's fair to say a relatively modest contribution that grows over the course of 2023 and all the factors you can imagine that drive that. In particular, it's really driven by iStent infinite and turning on those MACs. Okay, great. Thank you all for the time. Our next question comes from Margaret Kaczor with William Blair. Good afternoon, guys. Thanks for taking the question. I wanted to follow up first on iDose. You, you referenced it a little bit, but maybe we can go a little deeper. You know, once it's commercialized, I guess, are you assuming that it's gonna coexist with something like a DURYSTA, or is it kind of a different patient profile, you know, for different patient profiles? Are they gonna compete with each other? You know, given the 505(b)(2) designation, you know, do you expect, I guess, most surgeons to start off in the combo current cataract setting or, you know, eventually standalone as they get more comfortable or maybe, you know, accelerate the standalone market? Yeah, Margaret, I'll be happy to answer it. First of all, I think the patient demographics and the people that we'll be seeking to target the patient candidates will be similar to what DURYSTA is currently advocating. I do believe that we'll have some pronounced advantages entering the marketplace that I've talked about before. I think, again, any objective observation, and with your channel checks, you'll find that as well. I think when we do launch this product, I think we'll see some classic a-adoption. I think there will be a strong movement towards the use of this in combination with cataract surgery. I think it's unnatural to be able to place this in combination with cataract surgery, either alone or even perhaps in combination with a product like iStent infinite, where the surge is deemed medically necessary. I do believe that there will be a parallel adoption in the standalone marketplace. As I said before, what we'll see typically is kind of a Pac-Man approach, where people will look at, you know, being able to reduce drug burden in patients who are on multiple medications. They'll look for patients who are non-compliant to begin with as areas that they'll target to be able to provide a 24/7 option and a compelling treatment option for the treatment of glaucoma. We'll look for patients that have underlying ocular surface disease. There's a huge comorbidity between ocular surface disease and glaucoma. The last thing surgeons want to do or clinicians want to do is to exacerbate the condition by continuing to dose multiple preserved glaucoma drops on the surface of the eye. We'll also see surgeons that will want to just reduce drug burden. Every time we can reduce drug burden from three to two or two to one medications, or to make them medication-free, we substantially increase the rate of compliance in those patients, which then leads to better IOP control and the arresting of glaucoma moving forward. I suspect we'll see surgeons on the standalone side first. They'll want to look for pseudophakic patients. Those are patients that have already undergone a cataract surgery, and they'll want to be able to get their sea legs there first. Once they do, and many will start there and then move quite quickly into phakic patients and into these patient groups that they believe we can have a superior or potentially superior treatment alternative. Okay. That's very helpful. Thank you. You know, just a bigger picture macro question. You know, we talked about the guidance, and kind of the puts and takes there, but I don't recall you talking about staffing. Anything that you guys are seeing here recently, you know, are we in a more normalized environment now in 2023 or is it still a headwind? Thanks. No, Margaret, I think it's still very much a dynamic that's in play, right? I think it's in probably our quarterly summary document there. We may not have referenced it in the prepared remarks. You know, throughout the practices, I think ophthalmology is not immune to what you're hearing probably from other folks in the healthcare industry. Hospital staffing, administrator staffing across both ASC and the hospital setting, remains a challenge, both in terms of finding those folks as well as retaining them and not experience the turnover. You think about the expertise that's required to successfully, you know, operate in an ASC or a hospital, and that turnover slows them down. I think, relative to what we've been through with COVID, we all feel much better going into 2023. That dynamic absolutely remains. Okay. Thanks, guys. We'll take our next question from Joanne Wuensch with Citigroup. Hey, this is actually Anthony on for Joanne. Thank you for taking our questions. First one I have is quick. Just are there any details you could provide on the IDE trial for Infinite that's extending the label, size and length of follow-up, any details? Then I just had a follow-up after. You, sorry, the first question you had was on the infinite IDE, the expansion trial, in that. Do you wanna cover that? I'll be happy to cover that. What we're gonna be looking to do is, in fact, we're planning on a meeting with the FDA in short order, and that will be to develop a treatment protocol under an IDE where we'll be able to expand the labeling claims of iStent infinite, which you know right now is labeled for adult patients who have failed on medical and surgical therapy. We'll look to move to far earlier in the interventional treatment algorithm to patients with mild to moderate open-angle glaucoma. We have already prepared our approach to the FDA. We'll be meeting with them shortly, and we'll be looking to begin that trial later this year. I should mention just to look at the kind of the prowess of our portfolio. I think it's important that I mention that just this year alone, not only will we be looking at an iStent infinite mild to moderate IDE opening, we'll be moving forward with iLution with travoprost. As you know, we have an open IND there. We'll be meeting with the FDA to open an IDE up for the PRESERFLO device now that we've taken full command of the regulatory and clinical strategy from Santen. We'll be moving forward with the phase IIb trial of the iLution dry eye product based on the significantly powerful and early results we achieved in the early phase II design. We'll be moving forward with a phase I design with our excimer retinal program. There is so much under the hood here, so many good things going on, and we're gonna start to see some of the fruit from this labor, appear in certainly during this planning period. Great. That's helpful. Then, just in corneal health in the quarter, came in stronger than we were modeling. I know last quarter you called out some reimbursement headwinds. Can you just talk about maybe what drove that strength in the quarter and if reimbursement has improved? Yeah. I think we've talked about this for some time in the corneal health business in the U.S. in particular, where we had seen increasing volatility in the commercial payer landscape. Obviously whenever you see that, customers tend to react and be a bit more conservative as they think about treating patients under these various plans. Around the middle part of last year, we started to really put a lot more muscle into our payer relations effort and other investments in our market access organization that we talked about. I think we've seen good early returns on those investments. I think you saw that in the fourth quarter as we were exiting the year. It was a strong quarter, you know, north of $18 million sales and I think record for Photrexa sales of a little more than $15 million. We were encouraged. It's still early as we deploy these efforts and the investments we've been making, but we were certainly encouraged by the results in the quarter. All right. We'll take our next question from Matt O'Brien with Piper Sandler. Hey, this is Phil on for Matt. Thanks for taking our questions. For starters, just on guidance, you know, I don't wanna beat a dead horse or anything, can you give your puts and takes from only including modest contributions from new products, and that's namely iStent infinite. I think in the past, you've expected to garner reimbursement through the first half of this year. Has securing, you know, PFS coverage and payment been a slower process than you had previously thought? Well, yeah, I could cover the Infinite component when you talk about the broader questions on guidance, whatever you've got. I think as I said earlier, we've said for a while, it's this is a six to nine-month process. There really is no statutory timeline that you can rely on. We can only rely on our experience historically with the products that we've brought through the MAC process. So far, we're on track. You know, we're making good progress, but it's still early in that process. You know, we've talked about something that is in the mid-year Q2, Q3 type timeframe in terms of starting to really lock down the coverage there. I hope we continue to be on track with that, which as I said, you know, as it relates to our guidance, sets us up to a more, you know, second half-weighted, performance, particularly out of iStent infinite, and what it means for our U.S. glaucoma franchise. Great. Great. Just for my last one, for iDose, do you still expect a 10-month timeline here from when you've submitted to approval, or could that, you know, approval... What I'm really getting at, could that approval kind of bleed into 2024 here? I know it's it might be a bit too early to ask this as well, but, you know, the target label being so broad, so how should we think about, you know, that initial adoption? I think you're really targeting, what, early-stage ocular hypertension to late-stage disease. How should we think about that initially? Let me take the first part of your question first, or second part first. The label is under the 505(b)(2) designation. It'll be for the reduction of ocular pressure in ocular hypertension and open-angle glaucoma. The label is invariably wide, which we love for several reasons. It will allow us to segment the market and to target us in a sophisticated way where we think we can achieve the earliest and best adoption for patients. In terms of the filing for the NDA, we will be filing our NDA, as I said, imminently. It'll happen this month. Typically, what the FDA will do is establish a PDUFA filing date, a statutory date in which they commit to finish the approval process for the FDA approval of your product. We are targeting that approval, continue to target that to be before the end of the year. Things always change in moving to 2024. Clearly that's always a possibility, but it's not one that we believe will happen. Great. Thank you. We'll take our next question from David Saxon with Needham & Company. Hi. Good afternoon. Thanks for taking the questions. Maybe I'll start with glaucoma. I mean, last year, you obviously lost a lot of share to canaloplasty and goniotomy cases. Just wanted to ask how you're thinking about the opportunity to recapture that share given, you know, iAccess and iPRIME continue to ramp in the back half. Are there any reasons why docs you lost wouldn't come back to the platform, especially now that you have more products in the bag? Yeah. I mean, as I said earlier, I think when we look back on this year, it's hard not to be proud of how things turned out relative to expectations as we were entering it. As I said, I think it really speaks to the strength of our products and our commercial organization. I think those same things hopefully will benefit us as we continue on our journey here in 2023, and we continue to add, you know, more access to these products through iStent infinite and really providing what we think are best in class alternatives to customers that have been our customers for a long time. I think that ultimately we stand to benefit from that. The impact of that we'll see not just in 2023, but hopefully in 2024 and beyond. Okay, great. Thank you. I mean, we've heard some larger companies talk about a large cataract backlog, which I imagine you'd benefit from. Just wanted to hear your view on that and maybe what's assumed in guidance in terms of potentially seeing above normal mixed market growth in 2023. Thanks so much. Yeah. Well, it's always hard to predict how those things play out, when they play out, how much of impact that has in any given quarter or period of time. I think a lot of that ties back to the question that we received earlier around staffing and some of the constraints there. We've certainly seen amongst a pretty large group of the practices that their backlog or their time to scheduling of procedures has continued to extend out. A lot of that's because of staffing constraints, right? As they've tried to get back to more normalized schedules, in many cases, staff turnover or lack of administrative or OR staff can slow them down. They schedule out a little bit further. I think it's certainly a potential tailwind. Exactly when that plays out for the marketplace, is a little harder to predict. Great. Thank you. Our next question comes from Steven Lichtman with Oppenheimer. Hi, guys. This is Ron for Steve. Just wanted to ask if you guys are looking for any incremental headwinds from the last physician fee schedule reimbursement cuts and staffing. I know you already gave some colors about that, but how are you thinking about that in terms of 2023 guidance? Have a follow-up if that's okay? Yeah. I mean, I think the question you're asking is largely centered around the U.S. glaucoma franchise, and I think we've tried to factor in pretty much all the dynamics, our expectations around, you know, any continued headwinds associated with the CMS pro fee cuts, staffing considerations, our new product launches and additional, you know, coverage and reimbursement for some of those. I think all those things are really wrapped into our expectations. You know, I will repeat one thing I said earlier, which is that, given all that we've been through and kind of what we see in front of us, you know, we've taken a conscious effort here to try to really walk before we run as it relates to setting those expectations for 2023. Okay. If I can just follow up, maybe hopefully not exactly what people asked before, but around the Corneal Health business it's been growing steadily for a while, and it's been really, really great. Just how are you guys looking at that in the future, looking at that taking maybe a much bigger chunk of your business? How are you thinking about the second trial that's going on, the repeat trial for Epi-On? What are your expectations for it in terms of how's it going with enrollment and when you finish it up? Sure, Ron. I'll start off that if, Tom, if that you can. I think, you know, as we think about 2023 specifically in the Corneal Health franchise, it's reasonable to estimate high single-digit type growth for now. We talked earlier in the call about some of the investments we've been making and some of the early return we've been seeing on that certainly in the four th quarter. I think that should continue to benefit us in the coming year. It probably will likely be offset a little bit in the short term by enhancements that we've been making to our co-pay assistance program, which is a gross to net adjustment, and the diversion of some of our patients into that Epioxa trial that you've asked about. As I think Tom said earlier, and we've been pretty clear, we're now fully into that process of enrolling patients for the Epioxa clinical trial that's underway. I think that's the only comment I'd make is we found out from the FDA that they would require this second clinical study. I think it was in the late October timeframe. We moved heaven and earth, we already began enrolling patients beginning in January. We have over a couple dozen sites already committed and enrolling. They're looking at getting 40 up and running in short order. We're moving to have this fully enrolled by the end of the year. If we do the math from there, we'll look to target having a commercially approvable product in the U.S. by the end of 2025. Okay. Thank you guys so much. We'll take our next question from Allen Gong with JP Morgan. Hi. I just had a quick one since I think a lot of the more pressing questions have been asked. You know, when I think about 2023 and beyond, it feels like you've definitely been putting a lot more emphasis on iDose and iStent infinite. You know, when it comes to iAccess and iPRIME, you know, the former of which is already contributing at least a little bit, you know, why shouldn't we be expecting to see more contribution from those products in 2023, especially given, you know, the success we've seen from kind of similar products in the category? Yeah, I mean, we've seen contribution from both iPRIME and iAccess, right? Both in 2022 and as we move forward here in 2023. I think each will continue to grow as the year goes on. I think it's just that at this stage of the game, we don't wanna get too ahead of ourselves as it relates to the trends and dynamics there as they go forward. We do certainly feel confident that the portfolio of alternatives that we've got will serve us well as we make our way through 2023 and go into 2024 and beyond. Sorry, just to slip in a quick follow-up. You know, I'm sure you're tired of hearing about it, but I feel like the reimbursement landscape has continued to, you know, have a bit of noise here, especially when it comes to the more invasive techniques. You know, do you have any thoughts on that, how it's, you know, maybe impacting your competition and how it could impact your own portfolio going forward? You know, I think we've been on the record for I don't know how long now, saying that there was going to be a lot of moving parts as it relates to the reimbursement landscape and whether that was obviously part of it with our, with our own trabecular bypass codes going through the Category I conversion or some of the evolution that's been happening with respect to whether it's, you know, canaloplasty or whether it's goniotomy, or all the various alternatives in between. I think that the, you know, reimbursement landscape and payers generally are continuing to refine their own algorithms around what they think is supportable from a reimbursement standpoint. When I look at it from our standpoint, that's the benefit of having the portfolio. We have all of the tools that are available to these surgeons. Depending upon the individual, MAC or payer or hopefully most importantly the patient need, we have a solution that hopefully can meet those, that patient's algorithm or the surgeon's algorithm. All right, we'll move on to our next question from Anthony Petrone with Mizuho Group. Thanks. I'll start with a question on iStent infinite and then a follow-up on iDose. On iStent infinite, maybe just curious how we should think about standalone versus combo cataract playing out over time. Certainly if we do secure physician fees similar in line with where the first two MACs have come in, you know, should we assume that combo cataract, you know, dramatically gets cannibalized over the next few years in favor of standalone? Would that actually improve your pricing? Then I'll have a follow-up on iDose. Yeah. Hi, Anthony. I don't know that that is really a trend that I would call out as a significant one going forward. The expectations, at least for us, is that if a patient is being treated for a cataract and they're co-morbid with glaucoma, the surgeon is much more likely still to treat both at the same time, handle that patient in one visit versus decoupling it, which I think is partially is what you're, you were suggesting may occur. There may be some of that. I don't think that's really the primary trend that I would call out. What I think we're more focused on with iDose and iStent infinite is really something you've heard Tom talk a lot about, which is, you know, since the, you know, the founding of our company, the idea that we can truly drive an interventional glaucoma mindset and start treating these patients in a standalone manner, irregardless or irrespective of whether they've got cataracts or not. And that's where our focus is at, is providing what we think is a terrific solution for these surgeons to really intervene on behalf of the patients. That's helpful. Then on iDose, should we expect an AdCom panel, you know, perhaps ahead of the PDUFA date? When we think ahead to reimbursement, you know, we look at DURYSTA, they have a direct physician office reimbursement channel, but they also leverage specialty pharmacy. Should we expect the same for iDose? Thanks. I think with reimbursement, I think you've seen how we handle these issues in the past. We have a comprehensive approach. We've got a really strong payer group and market access group that's available. I think, you will know that this is gonna be a buy and bill procedure in the marketplace. You can expect that we'll have both options available for practices to purchase this and buy and bill directly or to go through specialty pharma. We've already thought through those machinations. We'll have a full sophisticated plan up and ready, available at launch, and we expect again to have a very meaningful launch beginning truly again in the second half of 2024. Maybe on the AdCom, do you expect an advisory committee meeting? I do not. Okay, thanks. That concludes the question and answer session. I'd like to turn the call back over to the company for any additional or closing remarks. Okay. Well, I wanna thank you all for your time and attention today and for your continued support of Glaukos. We thank you for your interest and wish you a good day. Thanks and goodbye. That does conclude today's presentation. Thank you for your participation, and you may now disconnect.