Glaukos Corporation

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to Gloucester's fourth quarter and full year 2025 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, Simply press star, then the number one on your telephone keypad. I would now like to turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Chris, please go ahead.

Thank you and good afternoon. Joining me today are Galacos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurmond. 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 be read by investors before the regularly scheduled quarterly conference call. 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 and clinical trials, U.S. and international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition, and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations 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. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.cloudcoast.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 Glaucos Chairman and CEO, Tom Burns.

Okay, thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glockos reported record fourth quarter consolidated net sales of 143.1 million, consistent with our pre-announcement last month, and up 36% on a reported basis and 34% on a constant currency basis versus the year-ago quarter. For the full year of 2025, consolidated record net sales of 507.4 million, who is 32% versus 2024. We are also reaffirming our full year 2026 net sales guidance range of 600 to 620 million, which implies continued strong year-over-year growth of more than 20% at the midpoint. A record fourth quarter and full year results reflect a highly successful year of global execution across our key commercial and development initiatives and underscore the dedication of our global teams strength of our differentiated technology platforms, and our evolution into a more diversified ophthalmic leader. From a corporate perspective, 2025 was a milestone year. In addition to surpassing a half a billion dollars in annual sales, we celebrated our 10th anniversary of our 2015 IPO, surpassed 1,000 employees worldwide, and broke ground on a new facility in Huntsville, Alabama. As we enter into 2026, we are well positioned to sustain our strong growth momentum, led by two transformational growth drivers, including the continued advancement of the interventional glaucoma treatment paradigm with IDOS-TR, along with the launch of Epioxa, opening up a new paradigm in interventional keratoconus and rare diseases. These two highly differentiated and durable market opportunities underpin our confidence to deliver a best-in-class, growth profile extending well into the next decade as we continue to invest in and advance a robust industry-leading pipeline while remaining disciplined in capital allocation, focusing on ROI-driven investments and cash flow. Our record fourth quarter results are a testament to the progress we continue to make in advancing our mission to transform vision therapies for the benefits of patients worldwide. Within our U.S. glaucoma franchise, we delivered record fourth quarter net sales of 86.4 million on strong year-over-year growth of 53%, driven by growing contributions from IDOS-TR, which generated sales of approximately 45 million in the fourth quarter. IDOS-TR's positive clinical outcomes continue to generate momentum with sales of approximately 136 million in 2025. reflecting strong physician adoption, reaffirming the compelling patient impact of this game-changing therapy. Operationally, our teams continue to execute well on our plans, focused on growing training surgeons and accounts, increasing utilization, broadening market access, expanding the clinical evidence, and accelerating targeted marketing investments. We believe IDOS-TR remains early in its overall adoption curve, with significant value yet to be unlocked as we expand market access and build on the progress in 2026 and beyond. Last month, we were pleased to announce that the US FDA approved our NDA labeling supplement, allowing for unlimited re-administration of IDOS-TR in patients who maintain a healthy cornea. We welcome this important labeling enhancement and believe it should help expand access for patients who may benefit from a repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time. With IDOS-TR as the foundation, our goal to advance and improve glaucoma treatment by driving earlier intervention continues to gain steam as we educate surgeons and thought leaders globally to organically drive this broader evolution in the standard of care for the benefits of patients. While we remain in the early stages of these interventional glaucoma efforts, we are encouraged with the increasing levels of clinical interest for this paradigm-changing evolution. Moving on, our international glaucoma franchise delivered net sales of 32.8 million on year-over-year growth of 18% on a reported basis. and 13% on a constant currency basis. This strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward as the standard of care in each region and major market in the world. As previously discussed, we continue to expect new competitive product trialing headwinds in some of our major international markets as we progress through 2026. partially offset by growing contributions from Kysted Infinite, following its EU MDR certification and associated European commercial launch late last year. And finally, our corneal health franchise delivered net sales of 24 million on year-over-year growth of 12%, including for tracts and net sales of 21.4 million. As you know, during the fourth quarter, we were delighted to announce the FDA approval of Epioxa, a novel groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare site-threatening disease that is currently far too often undiagnosed and untreated. Interest from the physician community following approval has been very encouraging and reinforces our view that with Epioxa, we are ushering in a new standard of care for keratoconus patients and practitioners with the first and only FDA-improved topical drug fair of the corneal epithelium, the outermost layer of the front of the eye. As a reminder, Epioxin utilizes a proprietary combination of an oxygen-enriched novel therapeutic that is bioactivated by UV light in an incision-free procedure. It is the result of more than a decade of research focused on slowing or halting the progression of keratoconus while significantly improving patient comfort and minimizing recovery time to provide a new way forward for patients afflicted with this site-threatening rare disease. As we've discussed, the FDA approval of Epioxa has allowed us to reset and redefine our go-to-market approach to better address this site-threatening disease and truly expand patient care and access. Immediately following approval, our cross-functional teams commenced execution of our detailed methodical initial commercial launch plans ahead of epioxid drug availability expectedly in this quarter. Importantly, with this launch, we plan to substantially increase our investments in patient awareness, education, and access while addressing the long-standing challenges of underdiagnosis and undertreatment that have affected this rare disease community. Our efforts are designed to support patients and families at every stage, from awareness and diagnosis through ongoing treatment, making the entire journey as seamless, efficient, and patient-friendly as possible over time. As with all pharmaceutical launches, initial patient access will be gated by our site of care network deployment and typical payer adoption headwinds and hurdles, but we're investing in the infrastructure, teams, and processes necessary to get Epioxin to as many patients as soon as possible in 2026 and beyond. We've been encouraged by the progress we've made in short order following approval. First, I'm proud to report we are ahead of schedule in establishing our Epioxys site-secured network. Our early wave one efforts are yielding results with acquired O2N systems already actively deployed in locations covering nearly 50% of the US population and a broader pipeline of systems moving through the approval processes that would expand our treatment center reach closer to 90%. Looking ahead, we will continue evolving this network to bring treatment access closer to patients as reimbursement and drug acquisition pathways become further established and streamlined. Next, on the market access front, we have completed our initial payer communications and updated key payer databases with the details associated with the EPIAXA launch. Our payer team is already actively engaged today with insurers, representing approximately 50% of commercially covered lives in the United States, including four of the top five commercial payers. As a result, we have seen several early positive coverage determinations spanning across the Medicaid and commercial payer landscape. We successfully submitted for the permanent J code and expect it to become effective in July of 2026. based on the CMS cycle for J-Codes. Until then, we anticipate Epioxa will be commercially available under a new technology, miscellaneous J-Code, and anticipate measured adoption over this initial period until the permanent J-Code is in place. In addition, we've also rolled out various new patient services and support programs led by our patient access liaison teams designed to streamline care coordination demystify the insurance approval process, and advance covered decisions where possible. Our teams are also deploying new marketing and DTC campaigns designed to significantly enhance awareness, education, and detection, driven by increased engagement with the optometric community, the development of a handheld KC screening device, and expanded advocacy partnerships alongside new patient education efforts to identify and reach patients earlier. Finally, as we've discussed with the launch of Epioxa, a critical focus of ours is to improve patient access to the site-saving keratoconus treatment. On that front, we have successfully deployed a new financial copay assistance program for eligible patients and operationalized a comprehensive specialty pharma option available for our customers As you can see, we are very excited by the significant potential Epioxa offers to patients living with keratoconus and believe it will deliver an exceptional value to patients, providers, and the healthcare system. This enthusiasm was on full display during our recent national sales meeting where anticipation for Epioxa's availability later this quarter was palpable. We're proud to lead the way once again in forging a new path to drive expanded patient access and enhanced treatment standards. Beyond that epioxin, we continue to advance a broad and differentiated clinical pipeline across our five novel therapeutic platforms with several notable milestones. Within our iStent surgical glaucoma prep platform, we completed patient enrollment in a PMA pivotal trial for iStent Infinite in mild to moderate glaucoma patients during the fourth quarter and continue to advance a 510K Pivotal Study for the Pressor Flow Microshub. Within our iDOS platform, patient enrollment is well underway in the Phase 2b3 clinical program for iDOS T-REX, our next generation iDOS therapy, with initial results of our Phase 2a clinical trial demonstrating substantial ILP reductions of 8.6 to 10.8 millimeters of mercury through three months. In addition, we recently commenced a phase 3B study for high-dose TRIO and continue to advance several phase 4 studies. Within our iLink platform, we plan to bring a KC screening tool to market later this year and initiate a phase 3 program for our third-gen iLink therapy next year. Within our Iolution platform, we commenced the Phase II study for Iolution demodex blepharitis in the fourth quarter. And finally, within our retinal platform, we recently completed enrollment in a first in human clinical development program for GLK401, our intravitreal multikinase inhibitor retinal program in patients with wet AMD. Despite being a relatively young company, LogCoast has invested over $1 billion in R&D since inception to develop a robust pipeline focused on chronic and rare ophthalmic diseases. Our continued investment in R&D remains best in class, underscoring our commitment to going first and advancing the standard of care for ophthalmic patients worldwide into the future. In conclusion, at Glaucos, we're in the business of pioneering entirely new marketplaces within ophthalmology. Innovation is at the core of everything we do as we advance our mission to transform vision therapies that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. Our mantra of We'll Go First embodies our commitment and determination to take chances push the limits of science and disrupt the legacy of treatment paradigms in glaucoma, rare disease, and retinal diseases through our pursuit of game-changing innovation. Our record fourth quarter and full year 2025 highlights the strength of our strategy and execution as we continue evolving into a diversified ophthalmic leader with multiple transformational growth drivers in IDOS-TR and Epioxa and advance our mission to transform vision therapies for the benefit of patients worldwide. So with that, I'll open the call for questions. Operator.

At this time, if you would like to ask a question, press star, then the number one on your telephone keypad. To withdraw your question, simply press star one again. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Tom Steven with Staple. Please go ahead.

Great. Hey, guys. Thanks for taking the questions. First one on Epioxa. Tom, you mentioned early positive coverage determinations from commercials and Medicaid, I believe you said. Can you elaborate on kind of the key highlights here a bit, and then just broadly to what extent

has there been any payer pushback on pricing um of epioxa and or uh the photrexa discontinuation hey thomas it's joe um i'll start up there tom with that comments he certainly can so from a payer standpoint it's important to remember that you really start to get a lot more of the coverage policies in place once you've got drug and channel and you're actually adjudicating the claims In the early days, it's all about the clinical education associated with the product, making sure those payers understand what Epioxa is, what it means for patients, and how that's differentiated from Botrexa that they've obviously known for several years now. So when he says that there's a positive development in terms of early policies, It's really because it's even a bit surprising in the context of a normal drug launch here in this case. And pre-drug and channel, you're getting positive outcomes with a handful of Medicaid societies as well as with one of the larger blue plans out there. And so, you know, all of the conversations so far have been much more clinical in nature. We've not heard any formal or informal pushback. from payers on the pricing dynamics associated with epioxids. So we continue to move forward and look forward, obviously, to getting the drug officially launched, if you will, and engaging, you know, on a claim-by-claim basis with these payers and ultimately getting it to a place where many more have the positive coverage determinations that we expect.

Got it. That's great. And then my second question on IDOs, Joe, maybe just stick with you. Can you talk a bit about kind of the key factors that drove the sequential deceleration in revenue in 4Q now that there's been some time to digest? And maybe more importantly, you know, what's your level of confidence in continued sequential growth here in the first quarter? Maybe you can speak about how to think about, I guess, IDOS growth directionally in 1Q as well as throughout 26. Thanks.

Yeah, sure, Tom. I think from an IDOS perspective in the fourth quarter, and we talked a little bit at a recent conference, we did see a couple of factors up. So we did continue to grow sequentially and grow nicely. I think it was in north of 10% sequentially. But underlying that were a couple of dynamics worth calling out. The first is that in the fourth quarter, and this is learning a little bit for us in the context of IDOS, the mix shifts a little bit towards Medicare Advantage. There's a lot more volume done in the fourth quarter, typically, than ophthalmology. But because a lot of those benefits, and I'll call it the patient out-of-pocket dynamics and related, you tend to see a little bit more on the Medicare Advantage side relative to the fee-for-service patient population. And the second was just some specific things that Glycosin, I'll call it our rep incentive, that in looking back, we saw probably a little bit of pull into Q3 and a little bit of pull out into Q4 that on the margin, I think, also impacted that. And if you think about translating that moving forward, I think what I would say is we do expect continued progress sequentially into the first quarter with IDOS, despite it being a seasonally low quarter from procedure volumes. And as the overall year, which we can talk more about throughout your matter, we expect there to be continued sequential improvement each quarter throughout the 2026 time period.

Great. Thanks, Joe.

Your next question comes from the line of Adam Mader with Piper Sandler. Please go ahead.

Hi. Good afternoon. Thank you for taking the questions and congrats on all the progress. Maybe picking up, Joe, a little bit where we just left off, wanted to ask about top line guidance for FY26, the 600 to 620 million, and really just hoping you can kind of pull apart some of the different components, whether it's IDOS contribution, how you're thinking about the U.S. stent business and corneal health with epioxa. You know, any quantitative color would be fantastic, but even just, you know, broad qualitative strokes, you know, such as we expect this business to grow or not grow would be really helpful. And then I had a follow-up. Thanks.

Yeah, happy to do that, Adam. And maybe I'll start off. And obviously, if you have follow-up questions or others, we can dive a little bit deeper. But If you think about the guidance that we've set and kind of affirmed here today, which is normally the time when we set it for the first time, as many of you know, there's no question 2026 is another pivotal year for us. As our, you know, our efforts as you heard Tom say, to transform the standard of care in intermenstrual glaucoma with IDOS and ICEN Infinite are kind of now finally joined by what I'll call a complete reset and expansion of our investment, the launch of Epioxa. And so we were pleased to be able to establish, you know, an initial guidance range of $620 million, which, you know, at the midpoint represents more than $100 million of growth in this year. If you think about it by franchise, I think it's probably the easiest way to start. On the international glaucoma side, we expect high single-digit growth internationally for the year. As competitive launch headwinds really play themselves out in several of the key markets, as we've talked about for a couple quarters now, and they're somewhat offset by nice and infinite launches and the broader interventional glaucoma and market access initiatives that we have going on worldwide. I think in the early part of the year, that'll be a little bit higher than that. And then as some of the currency tailwinds wear off, we would certainly expect that to come in a little bit on the back half of the year. On the U.S. glaucoma side, we expect, embedded in the guidance, is growth in the 30% range year-over-year, driven entirely by IDOS-TR. I think, as we've said in prior calls, I think it's safe to start off this 2026 assuming that the non-IDOS business is flat on a year-over-year basis. And so the entirety of that growth I'm talking about is really being driven by IDOS. And that leaves corneal health. And while there are a fair number of, I'll call it moving parts associated with the launch of Epioxa and the transition from Fortrexa, I think we can confidently say we continue to expect that the franchise will grow modestly year over year, but with a fair amount of volatility, particularly in Q2 and as we enter into Q3, as Epioxa becomes available and that permanent J code is established you'll see the the warehousing effect that we've been thinking about and the sort of delay as those patients are working their way through the approval process and ultimately getting approval and treatment um as we kind of make our way through q3 and certainly into q4 where we think that the strongest results will be for that business that's really helpful joe appreciate all the color and maybe just for the follow-up i guess another modeling question and just wanted to ask for a little bit more color on um you know cadence quarterly

um realizing you just gave a little bit there but you know for q1 i have the street modeling i think 132 133 million uh of revenue which is down sequentially quarter over quarter um just curious if you have any reaction to that that figure and you know obviously epiox uh uh transition versus footrexa you know is is a little bit i think tough to pin down so any more um color you can kind of give us on how you're thinking about sequencing would be uh would be appreciated thank you

Yeah, Adam, it obviously is a bit tricky on the cornea side, but I'll zoom out for a second. I think for 2026, we'll probably deviate a little bit from those historical norms that you've been around the story for a while. You know that ophthalmic procedures tend to see seasonality of, you know, call it 22%, 23% in the first quarter and 24%, 25% in Q2 and Q3 and then 28% plus or minus in Q4. When you look at what's driving it for us, it's really based on the two primary factors you might expect. With the IDOS launch, as I mentioned earlier in the call, we continue to expect sequential growth quarterly throughout 2026. That will lead obviously to incrementally a more back half weighted IDOS contribution and US glaucoma number. And then from a corneal health perspective, I alluded to it in your first question, but we expect to see modest growth in the first quarter. as folks continue to do with Botrexa procedures in advance of Epioxa being available. I think we'll see a fairly material dip in Q2, as we really are in the heart, I'll call it, of the transition from Botrexa to Epioxa, and those patients are being entered in for the approvals and prior authorizations, but perhaps not treating the clip that we'll start to see with the J-code and, you know, as we make our way through Q3. I think Q3 will probably be a bit more of a flattish year-over-year quarter as the J code comes online and you see some of the patients moving out of the funnel and into treatment towards the latter part of that quarter. And then obviously we would apply to that as a pretty strong exit in the fourth quarter as the J code comes online and we start to see a little bit more normalized treatment patterns as we're exiting the year and heading into next. And if you think about that just the first quarter and the way you said that, I think the U.S. glaucoma business will probably be somewhat flat to Q4 as the non-IDOS seasonality headwinds are offset by IDOS itself expansion. Cornea, as I mentioned earlier, will probably be modest growth on a year-over-year basis. And international glaucoma will see – it's more normalized. So I think we'll see the same high single-digit to maybe low double-digit growth. on a year-over-year basis.

That's perfect. You gave a lot of great color. I'll leave it there. Thank you.

Your next question comes from the line of Ryan Zimmerman with BTIG. Please go ahead.

Hey, guys. Thanks for taking the questions. I'm going to try and do a little lightning round here and see if I can squeeze a few in. And they should be easy to answer. But, you know, the first one is just around the, how you think about the interplay between the readministration of existing IDOS and TRX and just how to think, you know, how you think about whether there's a cannibalistic effect there. And then, you know, just for clarity, you know, you called out 50% coverage on Epioxa, but I just want to make sure you don't have 50% covered lives. You're just in dialogue with those payers right now. And I'll just leave it there for now.

Okay, well, I'll start with the second part of your question, and if Tom has a job on re-administration, he can. So, as it relates to the epiasa coverage, now, remember, in rare disease and unmanaged categories, it's quite common that you won't have any formal coverage policy. You're monitoring actual prior authorizations and approvals to therapy over time to determine that you've actually got access. That access may come in the form of formal coverage policies, and it may come in informal ways, just through simple adjudication patterns that will have the confidence that patients who seek that therapy are able to get it if they qualify. So we're ahead of that time. And I think what Tom was saying in the prepared remarks, that we've engaged in a meaningful way in clinical conversations with payers that represent over 50% of those covered lives. And as a result, we've even got some early, you know, positive policy wins. It's important to remember that, you know, cross-linking as the standard of care, that's not new, right? We've obviously been at that for some time with Botrex and the Epiox procedure. And so as we move forward here, we certainly expect them to continue to recognize that and provide the access that these patients deserve on a clearly superior therapy in the form of Epioxa. as it relates to readministration and the interplay between that and T-Rex. I think if you're thinking about that, the question was meant to go from a long-term kind of modeling standpoint, Ryan. You know, clearly the goal has always been to provide patients and surgeons with as many options as possible. and depending upon the disease severity and where things are at clinically we certainly expect different surgeons that have different algorithms around whether they choose to re-administer a patient with idos tr or or t-rex based upon the clinical profile that exists with t-rex when we ultimately get through the fda process that is there when i think about from a modeling standpoint Ryan, part of that is to think about, you know, obviously there's a trade-off there potentially on duration. We have to prove that through the clinical trials. And there's the pricing considerations around a longer-acting therapy as well. And ultimately, I think where we land is Most importantly, we've now, or hopefully with the approval of T-Rex, we have multiple options for patients to remain on sustained pharmaceutical therapies for the duration of their life, if you will, with the disease, which the average patient from diagnosis to no longer needs a therapy will be in a glaucoma surgeon's care for over 20 years. So multiple shots to continue to treat these patients, whether it's with T-Rex or T-Rex.

And Joe, just a follow-up, are you going to let Alex just spend uncontrollably for this Epioxa launch? And I'm wondering if, you know, that's a subtle way of asking Alex kind of what your thoughts are on operating expense spend in 26 as you prepare for this Epioxa launch. Because, you know, certainly it's going to, you know, I think be a question around, you know, margins and operating profit and so forth, which, you know, frankly, I do have you start to show some profitability in late 26th. despite your ability to kind of spend aggressively here.

Let me step in before Joe speaks for me, Ryan, and address the three questions you asked. So let's talk about OpEx first and foremost. Our philosophy as a corporation still hasn't changed from what we experienced in 2025, which is we're going to continue to balance our capital investments against our revenues such that we're driving towards cash flow breakeven and potentially some cash flow generation over the course of 2026. And with that in mind, you know, you would expect to see our operating expenses have growth next in 2026. If you think about what does that growth look like, what I would tell you today or what I would guide you to is somewhere in kind of a mid-teens year-over-year growth percentage off our base of 42 in 2025. That should put you in the neighborhood of operating expenses around 555 to 565. in 2026. Now that is still going to show operating leverage in 2026, which is another of our goals as we continue to march forward within the business and what we're trying to achieve. So that's kind of what we're thinking. And again, those are the key things that, you know, even though, you know, we're doing this, we have these two really key growth drivers that we're investing in in Joe's organization. between the iDose launch and the Epioxa launch and that. And then we have what we believe is a best-in-class R&D pipeline that we have to invest in as well. And all those things are driving our decisions around our capital allocation.

I think there's no question for all of us, Ryan, that with the Epioxa launch and the reset model, whether it comes to significant investment in patient access and whether that's on the hub with the specialty pharmacy, with the DTC investments, or all the various things that are designed to drive, you know, awareness, diagnosis, detection, within the framework that Alex alluded to.

Yeah, thank you. Appreciate taking the question.

Your next question comes from the line of Larry Beagleson with Wells Fargo. Please go ahead.

Good afternoon. Thanks for taking the question. One on iDose, one on Epioxa. So on iDose, on the repeat label, excuse me, how do you think about the percent of de novo patients who will get a second dose And how do you think about the potential halo effect of this repeat dosing label to new iDose starts? And I had one follow-up.

Well, I think, Larry, from a readministration standpoint, we're going to have to watch that, right, in terms of those patients. I mean, certainly, we've actually already seen our first readministration happen in the OR, and it's driven by the things that you would hope to hear, which is that the patient themselves was seeking that, you know, an early patient. who was getting into the area where they would potentially benefit from an incremental administration, and they were seeking it because they didn't want to go back on drops. They appreciated the value, if you will, of having the IDOs working for them. And so I think over time, we'll have to continue to monitor that. But clearly, if you go back to what I said earlier, if the average patient is in the care of a glaucoma specialist or a comprehensive doctor, for a little over 20 years with the disease. We expect there to be considerable opportunity for multiple re-administrations within the same patients over time, and I think that can certainly be a significant part of what I'll call the overall mix, if you will, relative to first-time therapy, certainly as we get further and further out into the planning period. And I do think that there's an incremental halo effect because At a baseline, surgeons can confidently have the conversation with patients about interventional glaucoma, knowing that they've got tools and solutions, including the repeat administration of IDOS, with those patients to manage their disease that way for hopefully their lifetime.

That's helpful. Joe, on EpiOp, can you talk a little bit about how quickly you expect to upgrade accounts to the new capital equipment, and can you put a finer point on when is expected to be completely phased out. Thank you.

Yeah, as you heard in the prepared remarks, we're already well down that path of at least installing the capital equipment required to administer Epioxa, and we would expect that journey to continue. I think as Tom mentioned in the remarks, we've already installed or are installing capital equipment at locations that would cover over 50% of the lives in the United States. And we've got various levels of approvals in various systems and providers where we'll be north of 90% as we make our way through here into the launch. So I think we feel really good about where we're at in terms of establishing that foundation, if you will, as we move forward. As it relates to Photrexa and the transition, you know, it makes sense, Larry, without getting too specific on dates, that with a July 1st J-code, we want to make sure that Photrexa certainly remains available to physicians through that period. And then, you know, as we make our way into and through the third quarter, we'd expect to transition that more fulsomely over to Abiox. Thank you.

Your next question comes from the line of Alan Gong with JP Morgan. Please go ahead.

Hi. Thanks for the question. I just wanted to start with a quick one on iDose. You know, we're roughly halfway through the quarter, and you talked about sequential growth throughout the year and starting in first quarter as well. But I guess, you know, fourth quarter had a little bit of one-time dynamics. It was a little bit weaker than expected. So when we think about sequential growth, How, like, what's the right baseline as opposed to be using in fourth quarter to then grow off of in first quarter? Or is that not the right way to think about it?

What I think, Alan, I certainly understand the question. I think that may be getting a little too precise for what we'll cover on a call like this. I think from our standpoint, overall, we gave the guidance that we gave. I gave the color on the first quarter dynamics and that expectation around IDOS. I think we've been really pleased with the trending that we've seen so far in the quarter with IDOS and the continued expansion thereof. As you may know and may recall, March tended to be a pretty important month in the first quarter, and so we still got that in front of us, but very pleased with what we've seen so far as it relates to IDOS.

Got it. And then I suppose, you know, your installed base, I think we've already gotten a few questions on this, but your installed base of Epioxa H2N is already, it feels like, coming a little bit faster than expected. So, and there's clearly a lot of excitement and even, you know, more durability in vitrexa than I think us on the street were expecting. So how, like, why wouldn't you be able to convert cases over, you know, fairly quickly, like just converting the cases you were doing on vitrexa over to epioxus fairly quickly once you have that J code?

Yeah, I think that's a great question, Alan. So I can confirm that our team has done a terrific job of getting ahead of even what our initial planning was around the, I'll call it the installation and the procurement process associated with the O2N system and really establishing the foundation, if you will, from which we can make that happen. The reason why we talk about the guidance in the context of Q2 and Q3 and the various things are there, you've got to take a step back. In the first half, you'll have a miscellaneous code that comes with its own set of unique challenges associated with patient access and working your way through. The approval processes can be a bit elongated at times when you're using the miscellaneous code. And then once you have the J code established, there's the various, you can imagine payer notifications and things that go alongside of that. The combination of those things alongside of just the early days of the approval process in any rare disease, let alone, you know, in this case, Epioxa, means that you're going to have a fair amount of patient conversation that translates into, I'll call it warehousing. It's not really warehousing, but as they're going into the approval processes, we certainly expect those approval processes to be much more elongated. as they're trying to go through that because of the miscellaneous code, because of the conversion of J-code, because of what you expect in terms of the initial technical denials, and then having to overcome those through appeals and peer-to-peers and all the things that go alongside of that. It just means that you'll probably have a bit of a gap, if you will, from when those initial patient conversations happen to where you start to see a hopefully more normalized, you know, patient pull-through dynamic into treated epioxides.

Your next question comes from the line of David Roman with Goldman Sachs. Please go ahead.

Thank you. Good afternoon, everybody. I was hoping maybe we could dive in a little bit more on IDOs utilization. I know you've talked about strategically prioritizing IDOs standalone cases, but maybe can you give us some flavor on how the different categories of utilization here evolve through the course of 2025, what your expectations are for 26 any considerations coming out of the November CAC meeting that are either reflected in your outlook or that may be percolating behind the scenes?

Yeah, David, you covered a fair amount of ground in that question, so maybe I'll start a little bit in reverse as it relates to the CAC meeting and what that we do or don't expect there. I mean, I think from so far, this process is really aligned with kind of our expectations as the max you know, somewhat understandably want to understand IDO's CR better and a goal that hopefully was achieved during the CAC meeting they had late last year. We've not really seen any signs of an LCD. I know there's considerations around that and continue to believe it will be premature at the stage of the launch. of course these things can be unpredictable and sometimes opaque so it certainly remains possible even if it's not probable at this point and um and the guidance that we've given has multiple different directions we can ultimately achieve that um as it relates to kind of where we saw the trending from 2025 and going into 2026 um you know from a handful of different spots Starting with kind of the max, as you can imagine, we continue to see more growth from the max where we have established professional fees. So in that sense, Novatas, Meridian, First Coast. We were pleased to see the addition of NGS to that mix in the latter part of last year, and that certainly contributed as we made our way from the third quarter into the fourth and continuing into the early part of this year. We see NGS added benefits. We have continued to see a relative percentage of procedures done where physicians are treating glaucoma at the same time as a cataract procedure. increasing that was expected given you know we've already changed the standard of care for for those patients um over uh over a prolonged period of time and as we enter into 2026 i think the expectations should be kind of going back to those same things that we knock down the remaining max i think at this point i can confidently say that we're we're the closest With Palmetto, I think we're on the doorstep there and hope to see that in the coming days, if not weeks. And we certainly are making a lot of progress since the beginning of the year with them as well as with WPS and CGS. And then I think I've mentioned this before, but the other big initiative for us in 2026 is really focused on driving increasing utilization in that broader patient population that's also represented by commercially covered lives as well as Medicare Advantage.

That's very helpful. And then maybe just a follow-up as you kind of think about the shape of 26. I know a few others have asked this, but you went down the path of introducing 26 guidance earlier than you normally do in November. And I think that was probably in anticipation of how we might perceive the pricing impact in Epioxa and trying to keep numbers at a reasonable place. But maybe you could just help us think about when you introduced that guidance to now and as you kind of sit here a few months later, what if anything has changed and where do you have more confidence or where do you see risks that you want to make sure we reflect in the outlook?

Yeah, I think it's a great question. I mean, first, when we introduced it, you're correct. I mean, with the pronounced change in how we thought about both the pricing dynamics, as well as all the considerations around the market access element of the transition from Portrex to Epioxa, we did want to make sure that folks didn't mistranslate that and get ahead of us in the context of the way we think it'll actually play out on the ground as we make our way through 2026. You know, I think since that time, pretty much across the board. Things have probably played out somewhat favorably. But if you can imagine, even inherent in the question, a lot of the things that we're talking about are later in 2026. And so whether it's the continued sequential growth and getting a feel for how that continues to play out in IDOC-R, or as we've talked a fair amount about, the epioxid dynamics, which are really largely weighted towards the second half and even the fourth quarter, It was premature, despite the positive underlying fundamentals of the site of care network for epiox or the pair progress, or even the trends that we've been seeing with Eidos, I think, to make any adjustments to, you know, our guidance at this early stage.

Very helpful. Thanks for taking the multi-part question.

Your next question comes from the line of Richard Newitter with Truist. Please go ahead.

Hi, thanks for taking the questions. Two for me. I'm just curious, are you factoring in readministration at all in the sequential improvement in the color that you gave on US glaucoma? And, you know, we can all back into the IDOS number. Sounds like you're pretty comfortable with where the consensus is based on your comments. So that's the first question. What, if anything, for readministration is even factored in there? And I'll just ask my second one. When you talk about co-pay assistance or market access programs that you're investing in. Can you elaborate a little bit more on what exactly you're doing with the specialty pharmacy access to make adoption more fluid for payers and patients or providers and patients? And are you also talking about your ability to move things through the denial process? Does that denial process go away once you have the J code in place? Because now it's a drug. Thanks.

Sure, Richard. I think I took all that down. But if I didn't miss something, you can circle back. I think it's fair to say that readministration was not a material consideration as we thought about the guidance, certainly as we set it back in November. And then, you know, as we've affirmed it here, we sit here today, given my earlier comments, we would expect there to be some readministrations as we make our way through the year. And some of those very early patients get into the window where readministration becomes um a viable uh option i think re-administration becomes a much more material you know contributor to how we think about the business in 2027 2028 and beyond than it is something that we're thinking about in 2026 and you know inherent your question then i from an ido standpoint I'll say it again. There are multiple different directions for us to try to achieve the numbers we put out. And in the context of both the existing MACs that we've got professional fees established today, the incremental professional fees that we expect to have on schedule, if you will, from the remaining three MACs that represent another 30% of the covered lives out there, or our initiatives that we're certainly investing a lot more in on the commercial and Medicare Advantage side. Each of those, I think, drive the confidence in the commentary, both around the overall guidance as well as the sequential improvement that we expect. Now, on Epioxa, and I'll call it the investments we're making both to drive or optimize patient access as well as turnaround time, I guess the best way you can say it on some of the support elements is there are always, from a service provider standpoint, good, better, best type programs. And when you launch a rare disease, You clearly have to invest in quote unquote the best, the best from a hub standpoint, the best level of service from a specialty pharmacy standpoint, incentivize maximizing access and driving the most experienced professionals within those organizations and the turnaround times associated with them. I think we've been on record as saying from a copay assistant that, you know, we'll have a zero dollar copay program for commercially covered lives that you hope that in the vast majority of cases, patients can qualify for that to make sure that that's not an impediment to access. And again, really all of these things, as well as our broader efforts that we'll have on DTC provider and patient education are all meant to be a substantial increase in the investment we're making to drive the awareness and the detection and then ultimately the treatment turnaround time for those patients who are afflicted with this disease.

Your next question comes from the line of Mason Carrico with Stevens. Please go ahead.

Hey, guys. Thanks for the question. Could you quantify the number of sites that have received the equipment to perform epioxi procedures or the numbers that have committed to it? I know that you called out the O2 system had been deployed to locations covering something like 40% of the population, but should we be interpreting that as a single epioxi site now covering a much larger geographic area than the average Photrexa site?

Yeah, Mason, I think I'll probably stop short of giving the specific numbers around the sites and the various things and simply say that when you look at it, to your example, if you have a site within the Atlanta metro area, for example, that's designed to cover that patient population. And again, that's not uncommon. So when you think about the launch, you want to make sure that you've got the providers who are the best at going through the process we're about to, that are committed to the care and are willing to go through the pair hurdles, if you will, and make sure that they're being properly educated. So you focus your efforts on those while trying to make sure that you've got the geographic reach that you need. And then over time, you start to supplement that to make sure, again, that patients uh don't have to wait um an unnecessarily long period of time to get access to care and so i would expect and we're happy with where we're at for the initial launch the wave one customers you heard tom reference earlier are wave one for a reason um and then ultimately over the you know coming you know months quarters and years we'll continue to expand that network out and and be offering more and more sites within a particular geography to make sure that we're uh that we're getting the access to those patients got it and then um

On the coverage front, I think you said you're in conversations with four of the five top commercial payers. Do you believe that you could realistically have a positive coverage decision from one or more of those in 2026? Do you guys have an internal target for the number of covered lives that you could have by year end?

Yeah, you know, Mason, I think I would take a step back to what I was saying earlier and You know, we'll see whether or not we have positive coverage determination slash policy and the variety of other things that help expedite patient access, you know, in 2026, whether it's with those top payers or others that are out there. The thing that we're watching most closely as we launch is that patients are able to work their way through the approval process, the prior authorization process, with each of these payers and the broader network of payers that are out there, such that we're able to confidently believe that we've got access, a pathway for the vast, vast majority of patients. That's the initial goal. From there, you start to focus more and more on optimization, whether or not they're getting that access through the pharmacy benefit or the medical benefit, whether they're getting that through on the initial prior authorization or through the appeal process, and ultimately whether or not they're achieving that access through an established positive policy that provides the cleanest and clearest pathway for them to get access to the drug.

Got it. All right. Thanks. Thanks, Mason. Thanks.

Your next question comes from the line of David Saxon with Needham. Please go ahead.

Great. Thanks, and good afternoon. Maybe two on the glaucoma business. First, on iDose, you talked about, you know, commercial cases. So, you know, what are you hearing in terms of doctors starting to really get into that patient population? I mean, is it kind of you know, more of a trickle or are you seeing that build? And then the second question is just on the iStent franchise. You talked about flat growth expectations for the year, I think it was. I mean, is that just because of how you're incentivizing the reps? Obviously, iDose is the focus right now, but, you know, what's the view there? Is that more of a market dynamic or anything around competitive dynamics?

thanks so much yeah david i think so first as it relates to the commercial and i lumped them in with you know medicare advantage because obviously those are um uh shepherded by commercial carriers it's very profi provider specific so in those geographies where we've um obviously had the proper Medicare fee-for-service coverage for a while, we're starting to see providers turn on where they're offering it to a wider swath of patients. And for those that are good at it, we're seeing them do that in a more fulsome way. Our efforts in 2026 are to really try to expand that in a much more significant and profound way as we make our way through the year. I think about it in kind of three, you know, called key pillars. We've been talking a fair amount about payer access on the epioch side. It's obviously relevant on the high-dose side as well. The good news is our foundation here is pretty strong. We've seen successful authorizations for therapy and the payment of both the J and the T code from payers that cover the majority of patient lives, including four of the five, and in that case as well, largest payers on the Medicare Advantage side. So I think we've got a pretty solid foundation from which to expand in terms of the payer side. The second is process optimization. It's going to, again, sound fairly familiar when we're talking about Epioxa, but it's been driving the entire ecosystem from our IDOS hub, our IDOS SP providers, to the payers and accounts themselves to reduce the barriers and increase the patient access and optimize the time treatment for patients on that side of the house. And then the last thing, which we've talked about not in a while, but the patient economics. Similarly, we have established programs to support commercially insured patients where most of them should pay as little as $0 a pocket. And then for MA patients, I think from the very early days of the launch, we've said that the data suggests that about 20% of those patients have no to the low out-of-pockets in terms of plan designs. And then access tends to increase from there throughout the year as patients meet those out-of-pocket requirements on other procedures. So I think we're still in the early innings. But we are seeing, obviously, encouraging signs on a provider-by-provider basis that we hope to expand as we make our way through 2026. As it relates to the ISNIP franchise, so it's interesting, obviously, implied when you go back and have done the work on the fourth quarter results, you'll probably see or have seen that we actually were back into the growth equation for our non-IDOS portion of our U.S. glaucoma business. And we talked about the trending heading this direction before, and so we were encouraged by the fourth quarter in that regard. But I think it's a little too early to call it a trend. And really, it is a large part about, I think, the first part of how you asked the question, which is there's a lot of rep incentive and focus and company incentive and focus around interventional glaucoma and Eidos in particular. And so we'll have to see a couple more quarters to determine whether what we saw in the fourth quarter was a trend or an anomaly that relates to that. And as a result, I think we've said for a little while now, it's safer to just assume that the ISINT or broader non-Eidos franchise remains flat on a year-over-year basis when assessing our 2026 guidance.

Great. Thanks so much, Joe.

your next question comes from the line of danielle on toffee with ubs please go ahead danielle your line is open oh sorry about that uh thanks so much for for taking the question good afternoon guys um forgot how to use the mute button uh just to follow up on on some of some of the questions around idos and standalone use I'm just curious, if you look at the business as a whole, so Eidos Plus, iSent, Infinite, what are you seeing there as far as the shift to standalone use? And at a higher level, maybe talk about some of the market development lift that's necessary to really build that market. And what you're seeing, I know it's early days, but I was at AO and I felt like there was a big focus on this. So I'm just curious what you can say there. Thanks so much. I'll keep it to one. Thanks.

Yeah, thanks, Danielle. I'm glad you were able to witness that, and I think you'll continue to see more and more of that, whether it's at the upcoming AGS meeting here later this week or ASCRS a short while later. and and i'll probably start in in reverse that um it is a significant investment we've been at this since the approval of idos really um in making that happen it's not our our first time going through transforming a marketplace obviously we did it successfully over the course of the last decade for those patients that were that were faced with a disease in combination with cataract surgery and it really is a combination of of incentive for your sales force alongside of the marketing efforts that we're making, the medical affairs efforts that we're making, the publications and the like. And when you put all that together and really build upon, I think, the enthusiasm that surgeons have out there for a disease that they know is interventional, is asymptomatic and slowly progressing. And there's a really large patient population in need for a variety of reasons. It's about being on that journey on a consistent basis at industry conferences and all the moments in between that we engage with those surgeons and really changing the actual practice dynamics and shifting towards the standalone treatment of these patients and aligning both the behaviors at the practice level with the clinical belief that exists in the vast majority of the physicians that I'm sure you're speaking to or have spoken with in the past. You know, when you put all that together, we continue to see substantial growth from standalone procedures, whether that be IDOS or ISIN Infinite. And it's not a big surprise, given everything I've mentioned, as well as the fact that you have a market that's 20 million eyes, 12 million of which are actively diagnosed and treated. And so, you know, you've probably heard us say, and certainly Tom say at other conferences and the like, that over time, we expect that the number of glaucoma procedures done in the United States will exceed the treated, it'll take time, but that's ultimately our focus and the reason why we're making such a substantial investment to the benefit of those patients.

Thank you so much. Your next question comes from the line of Joanne Grinch with Citibank. Please go ahead.

Good evening. Thank you for taking the question. I have some money. In no order, are you seeing physicians creating a wait list for Epioxa? Would that imply a stronger second half once the J-code is applied or put into place versus the first half? Could you see 2027 or even 2026? And if I do my math correctly, I-dose guidance is 225 million for the year. What makes that the right number? And thank you.

Do you mind repeating that you cut out a little bit on the 2027 versus 2026 part of your question?

Do you think revenue in 2027 growth rate will be faster than 2026 given the momentum of Epioxa?

Okay. So, I'll try to go through those in the order you asked them. So, from an Epioxa perspective, you know, we are, starting to see and we you know i'll give you an example we we certainly were seeing patients be enrolled in our hub for approval to epioxus so inherently in that means that a quote-unquote waitlist is is being uh created i don't know that it's enough um to quote-unquote obviously impact our first quarter i think there'll still be enough of faux trex there as i said earlier to drive you know year-over-year growth But we do expect that waitlisting dynamic, if you will, to be much more material in the second quarter, to the detriment of that for the cornea business, and probably the benefit of the latter part of the year, certainly the fourth quarter, perhaps even tail end of the third quarter, as those patients start to get approvals and access to the therapy. and ultimately treated. So we absolutely expect the second half to be the key contributor to those results. And as we learn more about that, we'll obviously dial in our expectations in a much more meaningful way. As we think about 2027 versus 2026, Yeah, I probably will stop short of giving, you know, at this stage, 2027 guidance implied by the comment. But clearly, you know, you've heard from us that the combination, the one-two, if you will, of continued acceleration with Eidos alongside of what we hope will be a meaningful acceleration with Epioxa makes not just 2026 an attractive year, but 2027 and beyond if we look out and think about what it could do in terms of driving our business and the top line associated with it. I think your last comment was the implied, we didn't give the exact number, but as you get to the numbers, I think there'll be a range of estimates that come in in that general zip code and what makes it the right number. But we're always looking at a bell curve of scenarios, the various puts and takes within these and trying to establish guidance both on a macro level as well as on a more micro level that we think is achievable for us And in this case, as I've said, you know, previously, I think we've got multiple pathways to both grow and continue to grow sequentially as well as achieve that. And as we make our way through the year, we'll continue, obviously, to update those views and provide them as we go forward here.

Thank you so much. And thank you for taking my multi-part question.

Thank you.

Your next question comes from the line of Steve Lichtman with William Blair. Please go ahead.

Thanks evening guys i'm a question on I do, can you give us a sense of how many surgeons you trained last year and and to date, or even qualitatively can you talk about where you are in that process and fill early to mid evenings any color on that would be helpful.

Yes, welcome to William Blair and I think from a from a certain train perspective it's not really been a focus and for us in terms of what we communicate the street that's by intention that that's really not the call it gating or limiting item for us. Our surgeon training activities have been as strong as they've ever been. The vast, vast majority of surgeons have already been angle trained over the course of the last 10 years of utilizing mixed technologies. So from a sustained pharmaceutical standpoint, we're good there. And it's really not been, I'll call it the step function that's driving where we're at. I think broader office administrative related considerations, reimbursement, confidence, professional fee. And then, you know, as we move forward here, bringing commercial Medicare Advantage online are much more key drivers to where we're at and where we're going. But so far, we've been extremely pleased with the pace and the overall ability for our sales force to train these doctors in the OR and get them comfortable with the IDOS procedure.

It makes sense. And then just secondly, I want to actually ask about international glaucoma. You know, it came in above initial expectations last year, you know, despite competitive dynamics you flagged going into 25. Do you think there was a delay in some of the competitive headwinds that we could see this year? And that's what's embedded in your 26 thoughts or just staying on the conservative side? Because it would seem like infinite could be a nice catalyst there. Thanks.

Yeah, and I think it is a balance, and we'll see how it plays out over the course of 2026. You have competitive interest in particular in some of our larger markets. In 2025, it did go a little bit more slowly than maybe we anticipated or certainly built into our forecast, and that's a credit to our teams that operate in those markets and the relationships they've built, and I think the differentiated positioning of our technologies. As we move forward, we do expect those efforts to continue to accelerate, but to your point, they're also balanced against uh our launch and launching of ice and infinite throughout the european region and some of the affiliated markets that follow um european approvals or clearances uh as well as you know continued sort of blocking and tackling that we have around opening up markets or markets within markets um and that journey never never never stops so i think as we we make our way through here it'll be that interplay you're you're right um and you know coming off of constant currency grows the fourth quarter of 13 And as you heard me say earlier, we expect sort of high single digit to low double digit, you know, in the first part of the year, ultimately abating to something a little bit slower in the second half to be in the high single digit range for the year, I think is a good place for us to start off the year as it relates to our guidance for that part of our business.

Makes sense. Thank you.

That concludes our question and answer session. I will now turn the call back over to the company for closing remarks.

Okay, I want to thank you all for your time and attention today, and thanks again for your continued interest and support of Wellcoast. Goodbye.

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.