Glaukos Corp (GKOS) 2025 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by. My name is Colby, and I'll be your conference operator today. At this time, I would like to welcome you to the Glaukos Corporation's third-quarter 2025 financial results conference call. Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com. All lines have been placed on mute to prevent any background noise, and after the speakers' remarks, there will be a question-and-answer session. (Operator Instructions) Please note, this call is being recorded and an archived replay will be available online in the investor relations section at www.glaukos.com.

I'll now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Thank you, and good afternoon. Joining me today are Glaukos Chairman and CEO, Tom Burns; President and COO, Joe 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 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, US 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.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 in Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables on 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, we'll turn the call over to Glaukos' Chairman and CEO Tom Burns. Okay, thanks, Chris. Good afternoon to everyone and thank you all for joining us today. In addition to discussing our record third-quarter results today, we're also excited to provide an update on Epioxa, our groundbreaking advancement in corneal cross-linking for the treatment of keratoconus following the FDA approval that we announced last week. Let's first start with the record quarter.

(inaudible) Glaukos reported record third-quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis versus the year-ago quarter. As a result of our strong performance, we are raising our full-year 2025 net sales guidance range to $490 million to $495 million compared to $480 million to $486 million previously. Our third-quarter record results reflect sustained growth acceleration of our business driven by growing iDose TR adoption and utilization, along with our broader intervention glaucoma or IG initiatives globally.

Within our US glaucoma franchise, we delivered record third-quarter net sales of $80.8 million on strong year-over-year growth of 57%, driven by growing contributions from iDose TR, which generated sales of approximately $40 million in the third quarter. iDose TR, a first-of-its-kind intracameral procedural pharmaceutical designed to continuously deliver glaucoma drug therapy for up to three years, continues to build commercial momentum supported by positive clinical outcomes and surgeon feedback that reaffirms our view that with the launch of iDose TR, we are pioneering a brand-new therapeutic category that has the potential to reshape glaucoma management as we know it today. Our teams continue to make great progress in the execution of our detailed launch plans for iDose TR, and we're encouraged with the continuing growing momentum.

Moving on, our international glaucoma franchise delivered net sales of $29.4 million on a year-over-year growth of 20% on a reported basis and 17% 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 this forward as a standard of care in each region and major market in the world. Last month, we were pleased to commence commercial launch activities for iStent infinite in our key European markets at the ESCRS annual meeting in Copenhagen. Surgeons’ initial interest levels in iStent infinite were very high during the meeting, reaffirming our view that EU MDR certification for iStent infinite will help us not only maintain and grow our presence in Europe, but also advance and accelerate our broader IG initiatives globally in the years to come.

In fact, (technical difficulty) our corneal health franchise delivered net sales of $23.3 million on year-over-year growth of 13%, including Photrexa net sales of $20.3 million. As discussed previously, our third-quarter results reflect the continued impact of the Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program or MDRP. Our record third-quarter results reflect strong execution against our key strategic priorities and are a testament to our evolution into a more diversified ophthalmic leader with transformational growth drivers that span across multiple geographies and disease states. As we advance the standard of care in glaucoma and rare disease with iDose TR and (technical difficulty)

Beyond that, we continue to advance our robust pipeline that supports our long-term best-in-class growth potential while remaining disciplined in capital allocation, focusing on ROI-driven investments and operational efficiency. This quarter, we saw continued gross margin accretion and maintained a strong balance sheet with $278 million in cash and no debt.

Now let's shift to our corneal health pipeline. As you know, last week, we were delighted to announce the FDA approval of Epioxa, a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare sight-threatening disease that is currently far too often undiagnosed and untreated. This approval marks a significant milestone for Glaukos and ushers in a new standard of care for keratoconus patients and practitioners with the first and only FDA-approved topical drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye.

As a reminder, Epioxa utilizes a proprietary combination of an oxygen-enriched novel therapeutic that is bioactivated by UV light in an incision-free procedure. This 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 sight-threatening rare disease. The FDA approval is based on results from two prospective, multi-center, double-masked Phase 3 pivotal trials that randomized a total of over 400 patients. Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.

Keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea that is often most aggressively advancing in patients under the age of 30. If left untreated, it can lead to loss of visual function and even blindness and is one of the leading causes of corneal transplants in the United States. Approximately 90% of cases of keratoconus are bilateral, and as many as 20% of untreated keratoconus patients ultimately require a corneal transplant. Conventional keratoconus treatments such as eyeglasses or contact lenses address visual symptoms only and do not slow or halt underlying disease progression.

Before we discuss our plans for Epioxa, it's important to understand the historical journey of Photrexa, our first-generation cross-linking therapy that, unlike Epioxa, requires the removal of the corneal epithelium. The FDA approval of Photrexa as an orphan drug was a major breakthrough back in 2016, as it became the first and only FDA-approved pharmaceutical therapy shown to slow or halt keratoconus progression. Following our nearly $0.5 billion acquisition of Avedro in 2019, we have subsequently deployed several hundred million dollars in commercial and R&D investments to grow our corneal health franchise, driving new clinical trials, expanding our salesforce and commercial reach, strengthening market access capabilities, and enhancing patient education and support programs.

These efforts have successfully resulted in Photrexa becoming the standard of care as excellent real-world outcomes that help preserve vision for tens of thousands of patients. While our disciplined commercial execution has delivered meaningful progress and our investments have made real impact on patients' lives for the past six years, the unfortunate reality is that access to proper care still remains far too limited, evidenced by the fact that we are still only treating up to 10,000 patients annually with Photrexa today. We estimate fewer than one in five actively diagnosed unstable keratoconus patients are getting access to Photrexa today, and many more are never diagnosed at all, an unacceptable reality for patients that we must change moving forward.

To make matters worse, only 13% of treated patients are under the age of 18, which is when many patients are most vulnerable to significant disease progression and vision loss. Further, given the invasive nature and extended recovery associated with the current Photrexa procedure, many patients are likely to delay or defer treatment. We estimate that as many as 40% of confirmed cases delay or decline Photrexa therapy, including procedures involving treated patients (inaudible) This is simply not good enough for patients, and we are determined to do better for this rare disease community.

Like other rare diseases, we believe there are several key factors contributing to why keratoconus remains too often undiagnosed and untreated today, including, one, lack of awareness and underdiagnosis; two, misdiagnosis and a focus on managing symptoms rather than proactively treating the underlying disease; and three, a burdensome and lengthy patient journey marked with reimbursement hurdles and fragmented care pathways.

The FDA approval of Epioxa marks a pivotal moment, introducing the first incision-free treatment for keratoconus and offering a groundbreaking new therapy for patients. Just as important, it gives us the opportunity to reset and redefine our go-to-market approach to better address this sight-threatening disease and truly expand patient access. With this approval, we plan to substantially increase our investments in patient awareness and access while addressing the longstanding challenges of underdiagnosis and undertreatment that have affected this rare disease community. Our new approach includes significantly enhanced awareness, education, and detection campaigns driven by increased engagements with the optometric community to establish KC detection centers, the development of a handheld KC screening device, and expanded advocacy partnerships alongside new patient education efforts to identify and reach patients earlier.

To ensure patients move seamlessly from awareness to clinical diagnosis and treatment efficiently, we will establish a network of engaged ODs and MDs and committed Epioxa sites of care that maintain a sense of urgency that these vulnerable patients deserve. In parallel, we will launch comprehensive patient services and support programs through our patient access liaison teams to streamline care coordination, demystify the insurance approval process, and advance coverage decisions where possible. These 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. This approval is a culmination of unrelenting research, development, and clinical efforts, and I want to thank our dedicated employees who have put in countless hours to make this approval a reality.

We’re also deeply grateful to the clinical investigators and participants in the clinical trials who played instrumental roles in bringing Epioxa to the United States. Despite being a relatively young company, Glaukos has invested over $1 billion in R&D over the years to develop a robust pipeline focused on chronic and rare ophthalmic diseases. Our continued investment in R&D is best in class, underscoring our commitment to going first and advancing the standard of care for ophthalmic patients worldwide into the future. We also just broke ground on a new 200,000-square-foot research, development, and manufacturing facility in Huntsville, Alabama, to support long-term growth and innovation, including the eventual production of Epioxa.

As you hopefully can see from our comments today, we are very excited by the significant potential Epioxa offers to patients living with keratoconus and believe it will deliver exceptional value to patients, providers, and the healthcare system. We’ve had several meaningful and informative conversations with key members of the physician and patient advocacy communities regarding this value in relation to pricing. Our approach for Epioxa reflects our commitment to responsible innovation, balancing clinical value, cost-effectiveness, and patient access. These principles help inform our pricing decision, which also reflects the significant investments we’ve made thus far and those we plan to make going forward for this rare disease.

After several years of thorough and thoughtful evaluation, based on these factors and supported by a robust set of internal pharmacoeconomic and published health economic analyses, we have established a wholesale acquisition cost for Epioxa of $78,500, which represents a significantly lower price versus nearly all other rare disease drugs, including those within ophthalmology. This is particularly true when you consider that Epioxa is unique as a single-administration therapy that’s capable of slowing or halting disease progression in the vast majority of patients that are diagnosed with this sight-threatening disease. We believe this not only provides a compelling value proposition for physicians and payers but, most importantly, enables us to make a fundamentally different investment in patient and provider education and awareness to enable more patients over time to be properly diagnosed and treated at a younger age to preserve their needless loss of vision.

Going forward, we anticipate Epioxa will be commercially available in the first quarter of 2026 under a miscellaneous J-code, with a permanent J-code established by July 2026. 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 Epioxa to as many patients as soon as possible in 2026 and beyond. Given the significant advancement Epioxa represents and our commitment to ensuring patients gain access to state-of-the-art incision-free treatment for this rare, debilitating disease, we made the decision to discontinue Photrexa commercial availability following a staged transition process in 2026. This transition will prioritize Epioxa as the primary treatment option, reflecting its safety, efficacy, and superior patient experience. Photrexa will remain temporarily available for patients unable to access Epioxa due to coverage or geographic limitations, and we’ll transition all remaining patients through dedicated support programs designed to minimize disruption and ensure continuity of care.

As we’ve discussed, with the launch of Epioxa, a critical focus of ours is to improve patient access to this sight-saving keratoconus treatment. With that in mind, in addition to our new awareness campaign and patient support programs discussed earlier, we will also deploy a new financial copay assistance program for eligible patients and intend to have a comprehensive specialty pharma option available for customers at launch. Our cross-functional teams have been hard at work putting these methodical plans together for several years now, and we are ready and excited to commence execution and make a difference in the lives of these keratoconus patients. The enthusiasm and energy for this new therapy and launch is palpable throughout our organization.

In summary, Epioxa represents not just a breakthrough in science but a breakthrough in how we deliver on our promise to provide the best possible care to patients. Epioxa is more than a product, it's a reset moment and a new way forward for keratoconus care. We’re proud to lead the way once again in forging a new path to drive expanded patient access and enhanced treatment standards.

Finally, as discussed earlier, we are raising our 2025 revenue guidance to $490 million to $495 million versus $480 million to $486 million previously to reflect our third-quarter outperformance and continued underlying momentum. We are also introducing a highly preliminary 2026 revenue guidance range of $600 million to $620 million. This preliminary outlook factors in our expectations as it relates to the continued commercial rollout for iDose TR, the surgical mix landscape, our international glaucoma franchise, as well as our corneal health franchise as we launch Epioxa and transition from Photrexa. We expect to refine this guidance range and provide additional commentary during our fourth-quarter 2025 earnings call expected to be held in February 2026.

In conclusion, our record quarter highlights the strength of our strategy and execution as we continue evolving into a diversified ophthalmic leader with multiple growth drivers. iDose TR is already driving meaningful growth today, and we expect Epioxa will begin to contribute in 2026 and beyond as our patient-oriented initiatives take hold. Combined with our robust pipeline that spans glaucoma, rare disease, and retina in particular, along with our disciplined investment and strong balance sheet, we’re well positioned to sustain our growth momentum 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?

(Operator Instructions) Tom Stephan, Stifel.

I'll start off with iDose, and I want to ask about the CAC meeting. Tom or Joe, maybe if you can discuss just the impetus or the rationale of the CAC maybe from what you've gathered in conversations with the MACs, and then maybe more importantly, talk to us about what your views are on the potential outcomes here.

I'll start off, and as always, Tom can also add his comments at the end here. I think from a rationale perspective and maybe how we're viewing it from a macro standpoint is this we see this as really the step in the process of educating these MACs and really educating them on, number one, the significant unmet need that iDose meets for glaucoma patients as you all know. Two, and importantly, the robust FDA and peer-reviewed level-one data evidence that supports its proper utilization in the care continuum; and three, ultimately establishing the patient access that our glaucoma patients and physicians deserve around the product.

Clearly, if you think about this moving forward, you can make arguments both ways, and we've seen some of that play out obviously in the early commentary from the investor community. In general, we're pretty confident that the considerable data behind iDose as an FDA-approved pharmaceutical, more high-quality evidence has been generated to support this pharmaceutical than virtually all of the glaucoma device solutions combined, including at least 15 peer-reviewed publications, and all that supported the FDA approval and the label that is when you look at it largely consistent with other pharmaceutical therapies for glaucoma.

So I think there are a handful of different paths that can emerge as we go forward, but I think what's most important is that for these MACs, they're taking a step to make sure they understand and are educated on what we already know, which is that iDose is a game-changing solution with a lot of evidence and data behind it to change the treatment paradigm associated with glaucoma patients here in the United States.

So from that standpoint, we look forward to having that engagement and for them moving forward from a more educated basis to adjudicate the claims that come their way.

Comments to add if I can to Joe’s. Let’s talk about some of the data that we already have in hand. So we’ve got two Phase 3 clinical trials, which you’re all aware of, that established the NDA submission and PMA approval with over 1,000 patients that are validating the use of iDose in standalone glaucoma patients. And more importantly, I think we’ve been prescient also as well as conducting a single-arm prospective study in combination with cataract surgery, which showed demonstrably powerful decreases in intraocular pressure, 11.3 millimeters from pre-treatment means. We’re conducting a prospective level-one study of iDose in combination with cataract versus cataract surgery alone.

We were also smart in conducting a study that we’re in the process of enrolling today, which is iDose in combination with iStent infinite versus iStent infinite alone. And so we expect those studies will validate what we expect to see, which is incremental and cumulative advantage of using these different products, all of which should be prescribed and used under the current label (technical difficulty) provider.

Got it. That’s great, really appreciate that color. And then my follow-up is just on Epioxa, and congrats on approval. Maybe a quick two-parter. Can you elaborate a bit on your confidence in executing with this level of pricing just in terms of payer coverage and reimbursement, and then how should we be thinking about 2026 for corneal health just as we consider the moving parts with Epioxa ramping as well as Photrexa transitioning off?

I think as it relates to coverage and continued access to -- or gaining access for Epioxa to patients, I think, like everything else, that's where there’s education at the payer level around the benefits associated with this therapy and the real cost associated with the continued progression of the disease and ultimately, as you heard Tom mention, too often these patients proceeding towards corneal transplants and other outcomes, let alone the continued impact from the visual impact that keratoconus has on many of these patients. So I think we’ll engage in that process as we go through it. We’re confident obviously that we have a best-in-class solution that works well for the patients afflicted with keratoconus, and so we look forward to engaging those conversations with the payer community.

As it relates to 2026, part of the reason why we decided to give the preliminary guidance for the year is to make sure that that was factored in at a macro level into the guidance and our expectations. You’ve heard Tom mention some of these. If you think about Epioxa rolling out over the course of the year, we have work to do to obviously establish the site-of-care network, the drug availability itself, timing in the first quarter, the reality of having a miscellaneous code throughout the first half of the year, the process of payers just updating their systems for the J-code in the second half of the year, and alongside that, customers updating their contracts and generally what I’ll call the slow and methodical process of establishing proper payer coverage and patient access for any rare disease, Epioxa will be no -- not dissimilar. So this is certainly one where we’re expecting in the context of the way we think about the 2026 impact that we will come out of the gate crawling before we walk and before we jog as we exit 2026.

Adam Maeder, Piper Sandler.

Congrats on the great quarter. Maybe just kind of piggyback (technical difficulty) the preliminary (technical difficulty) $620 million for next year, that's a little bit above consensus at the midpoint, and companies don’t typically get (technical difficulty) to do so.

And as we think about the (technical difficulty) of that revenue range, (technical difficulty) versus the health (technical difficulty) of each of those segments even if it’s just as simple as should each of the different segments grow next year, that would be helpful.

So Adam, you were breaking up pretty substantially on our end throughout that. I believe that you’re asking for more context or color around the guidance range of 2026 $600 million to $620 million and probably pushing a bit for more granularity around the constituent parts of that. So assuming that I’m correct on that, I’ll give you the answer.

As I mentioned before, we felt it was prudent with what we’re announcing in terms of the Epioxa approval, some of what Tom announced today, to make sure that we establish what I’ll call a highly preliminary view of 2026 and to really anchor ourselves around what we think entering into the year where we're at here in October. Our goal and our plan would be to provide more granular views by franchise during the fourth-quarter call.

But what I can say from a macro standpoint, we feel confident in this early range and that a variety of paths through each of the franchises, if you will, US glaucoma, international glaucoma, and certainly the corneal health franchise will enable us to meet the expectations of that $600 million to $620 million range that we’ve established.

I wanted to ask for just a little bit more around iDose’s performance in the quarter, really good number there. Did you feel (technical difficulty) that MAC that onboarded in early August? Just any color on how iDose is ramping as we head into Q4.

And the second part of the question is really just around the utilization and which patients are getting iDose. Is it being done early in the standalone setting? How much is coming from combination with cataract, and how much is with a second MIGS?

Again, you were breaking up a little bit, but I think the question was largely around iDose’s performance dynamics associated with that in the quarter, and then a little bit more granularity on the breakdown of standalone versus combo cataract utilization. So obviously, we announced in the quarter approximately $40 million of sales for iDose, a very nice step up from where we’d been running in the second quarter coming into the third. That, I can say, was broad-based in terms of what drove it. All of the MAC regions, if you will, contributed to that growth as did growing early commercial and Med Advantage utilization.

We saw new doctors picking up. We saw some who had maybe been part of early trialing now having received their payments from 2024 starting to get back into providing iDose as a therapeutic option for their patients. So it was really high quality.

And I would say, in terms of contributions from -- I couldn't hear you, but NGS obviously came online in August. Very early positive signs there, but realistically, the quarter itself looked very much like, in terms of its mix, what we've seen in the second quarter, where about 80% of the overall volumes were in the more established MAC regions, if you will: Meridian, Novitas, and First Coast. So the growth balance was across the board, but the weighting was still toward the more established regions in the country, which is not a huge surprise at this point. With that NGS announcement, you wouldn’t really expect to start seeing the impact of that until, at best, the later part of this quarter and really as you start moving into next year.

As it relates to the mix on the standalone versus combo cataract, as you know, that’s not something we directly track. We obviously are providing iDose TR for the benefit of patients afflicted with glaucoma, and how surgeons utilize that in combination with anything else, including as part of a combination cataract procedure, is not something that we know when it goes out the door. Anecdotally, we know that in those areas that have a little bit more established track record of reimbursement and professional fees that the rate of utilization in combo cataract surgery is growing. That makes sense, obviously, that's meets the surgeon where they're already at, which is treating the cataract and trying to take care of the glaucoma disease in parallel.

So we are seeing some growth in that in terms of anecdotally of the overall mix, but it is largely in those regions where you have more established reimbursement than some of the other MACs where we're a little bit further behind.

Larry Biegelsen, Wells Fargo.

I guess, Joe, I wanted to start with Epioxa. For those of us who have followed this a long time know that when Avedro came out with the $3,000 or so ASP, there was some pushback. So you're obviously moving a lot higher here. So what data are you going to use with payers that gives you the confidence that commercial payers will cover it? And how are you thinking about the growth in the 10,000 patients, I think you said earlier, treated per year with Photrexa today over time? Do you expect to grow that, or could you actually lose some patients to off-label corneal cross-linking treatments? And I had one follow-up.

Sure. I'll start, Larry, and others can comment as we go forward here. But for Epioxa, I think first and foremost and obviously the reset moment as you've heard Tom talk about, this is an education process, just like you'll recall to your point we've been around with Avedro back in the day as they purchase reimbursement around keratoconus itself, it was for Photrexa is to remind the constituents that are out there, including the payer community, that this is a rare disease that by definition, you referenced it yourself when you're talking about 10,000 patients being treated. In fact, that's an uber rare disease and pretty consistent with a type of treatment numbers, as we understand it, for other rare disease therapies in ophthalmology such as (inaudible) Tepezza for thyroid eye disease.

So when you compare from a payer perspective the relative value of a single procedure that can slow or halt the disease progression of a condition like this, and you think about that patient population and the wholesale acquisition cost Tom talked about, I think you're going to find it compares favorably to the broader rare disease landscape, including that within ophthalmology. I think more broadly than that, the conversation is one of education around what it takes to make sure that you're responsibly innovating in a category like this for rare disease and then what you have to do to drive meaningful change in awareness, in diagnosis, in detection, and in patient access, as you heard Tom about.

This is a different way of looking at the situation, but it was one that we had to look inwardly and ask ourselves what do we have to do to meaningfully change the outcomes that we're seeing in terms of too many patients not getting access to a sight-threatening therapy in the form of Photrexa. As we move forward with Epioxa, that's exactly what we're committed to do.

Now, you asked about the 10,000 patients. I have no doubt that in the early days, as you're working through the inevitable payer hurdles and the various things you have to do to drive education and get access through each individual payer that we'll face some headwinds there. But clearly, as we move forward, the whole reason for what we're doing is to meaningfully expand that number. And you heard Tom reference that we today believe we're treating one in every five patients who have uncontrolled or unstable keratoconus with Photrexa today. And so I hope that in the coming years, we'll put a meaningful dent in getting to what was, by definition, an uber rare disease with 10,000 patients to what would be merely considered a rare disease in the 50,000-patient range.

And that's something that will be hard to work at, but it's not something that's going to be turned on overnight in 2026 for sure, but it's the reason because each one of those patients deserves access to an FDA-approved, incision-free topical therapy that can arrest or certainly dramatically slow the progression of that disease.

That's helpful. I guess just for my follow-up, it truly is related. I guess I'm just thinking ahead as many people probably are to '27, '28, '29, at $78,000 and 10,000 patients, and I assume 90% done bilaterally, the numbers get pretty big. Is there anything else -- I mean, could you be doing 20,000 eyes in 2027, Joe? And should we be using an ASP of $78,000? Help us frame that beyond '26 for hopefully obvious reasons these are big numbers.

Yeah. Well, first, I think you have to do a blended average over time. I wouldn't use $78,500 in your long-term models. Obviously, we are a member of the Medicaid Drug Rebate Program, and we do provide discounting for that patient population as part of this. So when you think about a blended WAC, we'll talk more about that as we actually get into making the drug available. I think we went far enough in terms of providing our preliminary views on 2026. I'm not going to go that far in terms of 2027 and beyond.

I'll give you the bookend of what we're trying to target over a period of time in terms of meaningfully changing this for those patients, and I would add that whatever you assume in your models over the course of the next several years, you should also assume requisite investments associated with what we're talking about here to make sure that we're actually driving the awareness, the education, and the detection necessary to achieve those outcomes that you're talking about in 2027 and beyond.

Ryan Zimmerman, BTIG.

Great. Can you hear me okay?

We can, Ryan.

Okay, good. Choppy earlier, but maybe for you, Joe, a little bit on iDose. In the absence of the CAC meeting and the permutations that could come out of that, I'm wondering if you could talk a little bit about how you think about the ramp of iDose. And I ask that in the context of 2026, and do we think of iDose following a similar progression in kind of a linear fashion through 2026 and beyond?

Is there a point at which you see an inflection occurring where the scales tip, if you will? I'm wondering if you could speak to that and how you guys think internally about the progression and adoption of iDose over time.

Yeah, Ryan, I think that the world we live in is obviously multidimensional relative to when we're building models or we're trying to do this, and there's a lot of varying puts and takes when you think about that. But what we've clearly established is plus or minus a pretty solid linear-type launch in its early days. I think it's hard to accept that without looking at the constituent parts of that, right? And as you said in the context of 2026, we sit here today having put up $40 million of revenue in the third quarter, with, as I said earlier, 80% of that volume coming from Medicare regions that represent about 50% of covered lives.

So as we go forward, the CAC meeting and all the other education efforts that we're doing with these individual MACs to establish proper and appropriate fee coverage moving forward, simply getting the Medicare arena to the right place alone continues to leave us optimistic around what that means for 2026 and certainly beyond. And that's before, I think, you're touching on a little bit, you start to think about that broader utilization. We're starting to see some accounts across all patients who deserve to get access to iDose irrespective of what insurance type they have, whether that's commercial, whether that's Medicare Advantage, or certainly Medicare fee-for-service for other areas.

So as we make our way through and more and more folks focus simply on treating the disease and less on the insurance type, I think that's when they'll be able to start focusing on really driving meaningful awareness in the standard-of-care shift that we think iDose represents for these patients' benefit. But until you get to that place where you've got a little more stability, if you will, around that broader market access landscape, it's hard for physicians to really focus holistically on the clinical care continuum. But once you get there, I don't want to say it'll be an inflection, but I think it's what underpins our bullish optimism of what iDose will mean for Glaukos, our customers, and our patients, not just for 2026 but for the next decade as we continue changes to healthcare.

Okay, just related to the CAC meeting, the agenda was posted, the questions were posted a couple of days ago. I don't want to lead the witness here, Joe, and I don't know if you're going to comment on this, but I'm going to try anyway. The questions kind of infer that the studies weren't long enough, and I don't know if you have a reaction to that. You kind of articulated this earlier, but is that your sense that you're going to be educating them on the robust evidence that the totality of the data and that there is a misalignment in terms of understanding?

Or do you feel like this is coming in with maybe a little more purpose given how fast this has bubbled up, if you will, relative to the historical efforts we've seen in legacy meds? I'm just trying to still understand why this has happened as quickly as it did so early in the launch cycle of iDose.

Yeah, I think part of what you're talking about in answer to the latter is that we've also been trying to aggressively educate and advocate on behalf of our customers. You can take a step back, Ryan, and think about how much enthusiasm there is in the clinical community around iDose and what it means for the patients and the outcomes they're seeing, all the things that have led to the optimism that extends from that for you all in the investment community. That also leads to those physicians advocating to make sure they're getting properly paid and the coverage associated with it.

I think a combination of that is probably what has led them to want to ask the questions of the broader advisory committee to make sure they understand. Anytime you go into one of those sessions, there's going to be questions within that that make sense in the context of the way we or how our physician customers look at this and other questions that do not. And I think this preliminary question list reflects exactly that.

There are some in there that you can understand, whether they're trying to understand the overall fit of iDose into the treatment paradigm, and they want to ask that question of a network of experts, if you will. But there are others in there that clearly show they have not yet quite understood both the data, of which there's a lot.

And so I don't hold that against anyone. That's an education process that has to take place here in the coming weeks, months, if not years, as we continue to try to streamline that broader reimbursement coverage.

Alan Gong, JPMorgan.

Just as a quick follow-up to that, one question I do have is, you obviously won't get an LCD immediately after the CAC meeting, but should you get an LCD, what does that do to your coverage with the MACs that are currently holding out and the MACs that you're already working with? Will that change your relationship with the MACs that don't have you on the pro fee schedule yet? Will it accelerate that process, or will you still have to wait to get on pro fee?

Well, I think coverage and payment are two different things. And so from the standpoint that they attempt to appropriately value the procedural component associated with iDose, that process continues ongoing. We continue to have constructive dialogue with each of the three remaining MACs around that. Clearly now, we have with NGS being added 70% of Medicare lives with established professional fees and a whole lot of work that’s gone in behind that to understand how to value that and priced. So I think that process continues to unfold.

What you're talking about in kind of the way you asked it with LCDs and the like is much more around coverage determinations. And on that, I would just say that there are clearly scenarios that are positive for us, scenarios that present headwinds or areas where we have to educate them more fulsomely. But going into it, we don't have a bias either direction in that regard. We're just focused on making sure that we're educating them properly and that they understand what they're looking at in terms of iDose.

The one clear positive I'll say in any LCD that gets established is that alongside that comes Medicare Advantage coverage policies as well. And oftentimes, commercial carriers that are behind Medicare Advantage policies, they will wait until formal LCDs are established to force them into having policies of their own. So you can argue that there are certainly some opportunities associated with that should an LCD ultimately emerge from this line of work.

David Roman, Goldman Sachs.

I wanted to come back to the market development and education efforts around Epioxa. A lot of what you're laying out sounds like it actually mirrors that of a more mass-market disease and something that takes a lot of education. I don't know if it's direct-to-consumer. As I look across other rare disease categories, and I'm thinking more in the traditional pharmaceutical and biotech categories, there is a lot of investment around payer education and physician education. But maybe you could help give a little more flavor on some of the specifics around the investments that you're making and how we see those show up and over what time period.

Yeah, David, it's Joe. So I'll start macro and then get more micro for your question. From a macro perspective, what you think of in terms of large population-based patient education are the legacy direct-to-patient advertising commercials you see on broadband television during various sporting events or whatever it may be that's there to help make sure awareness is being driven. What's different with rare disease is it's much more of a needle-in-a-haystack exercise.

And so those efforts around awareness and detection mirror that of that broader disease mass market, as you said, but they're done in a much more targeted way to make sure that you're trying to find those patients who are most applicable based on where they're at in their own disease journey. And so a lot more of that happens in different forums and different communities that are more digital in nature, where folks are actively seeking out what's causing the change in their vision. It's important to take a step back here and remember that, you heard Tom say this, but with only 13% of patients are being treated under the age of 18, and we know the vast majority of damage is happening or certainly starting to happen and accelerating in the teenage years and into the 20s, yet the vast majority of patients aren't getting access at that stage.

You really have to redouble your efforts to find them much earlier in that journey based upon those early symptoms and early signs of keratoconus to make sure they're getting proper access to the detection and the very things that are necessary to diagnose them as a keratoconus suspect. And that's a really big investment from a commercial and marketing standpoint, and it's not just DTC, although that's an important part of any education. There's a lot in terms of what you do with your field organizations, and just to put that in context at a more micro level, David, today, the majority, if not all, of the treating physicians for Photrexa are in the MD community, but you're very much reliant upon the optometric community where the patients first present most often with visual acuity issues.

But there are 50,000 optometrists and numerous other opticians that serve a little bit as a primary care physician. So how you get to driving education in that community both digitally as well as with your salesforce and other marketing-related activities is a pretty significant investment. Now that part of it is really just the beginning in terms of driving awareness and education, if you will. You also have to then support.

And anytime you have a needle-in-a-haystack patient, and again, you heard Tom reference this in the prepared remarks, but these patients -- think about the number of insurance plans that are out there. And when you're only treating 10,000 patients, every single time one of those patients presents themselves asking for access to Photrexa and Epioxa, it's like this is the first time that that insurer has ever seen a claim because you're talking about 10,000 patients and 5,000 plans in the United States.

So to that point of really making sure you demystify the insurance process that you support them along that way with proper education as you go through that, and ultimately to the extent qualified, provide them with assistance as they go through are all major, major investments for us. Now, the last thing you have to think about is how that turns on.

We're going to have an (inaudible) on this in the context of broader P&L. We're going to have some of this happen right away, so it certainly picks up steam as we make our way into 2026 at the beginning, and then as we start to get the J-code established and our site-of-care network up and running in the second half, we'll try to elevate that up to, I'll call it a full-scale effort supporting those patients in that process and their journey as we make our way and certainly as we exit '26 into '27.

Richard Newitter, Truist.

All right, thanks for taking the question. I might have missed it, but I just want to make sure I'm understanding the components of your updated '25 guidance and how we should be thinking about the areas for 4Q and what's implied there. Can you just run through the segments?

I know you provided a prior outlook for corneal health, and I think it was flat to low single-digit growth for the year. Could you just give us a sense of what we should be modeling for that business and what the trend should be in the iDose sequential trend?

Yeah, Richard, happy to do it. No, I haven't addressed it yet other than announcing the updated guidance range of $490 million to $495 million. First, putting it in context, the performance thus far in 2025 and obviously highlighted by the results in the third quarter has really continued to exceed our internal forecasts, and based upon that, we raised our expectations for the year.

The biggest thing here in the fourth quarter is not new; we called it out on the last call, and that is to take into consideration the expected headwinds that may faze our corneal health franchise in the fourth quarter as we and, more importantly, our patients and customers prepare for the transition from Photrexa to Epioxa.

Secondarily, I would say that the fourth quarter is a little bit more of an elevated or more difficult comp from a year-over-year growth perspective in our US and international glaucoma franchises as you're thinking about and kind of looking at dialing that in relative to where we've been in the last couple of quarters.

If you think about the individual franchises within that, I would say that for international glaucoma, the dynamics here really remain unchanged from what we've talked about previously. We expect low double-digit growth in the fourth quarter based upon that slightly tougher comp that I mentioned and really combining that with the continued sort of competitive launch headwinds that exist in several key markets, so nothing new there.

On the corneal health side, I referenced I think a little bit of -- you'll back into the expectations there. We do expect to see a fairly material year-over-year decline, and that's certainly implied in the guidance as we navigate that transition that I mentioned before. And we've already started to see some early signs of that emerge even here in October post the approval of Epioxa, and we've even seen patients now starting to come and ask about Epioxa in favor of the existing Photrexa therapy that may be offered to them.

On the US glaucoma side, we expect growth in the mid-40% range year over year in fourth quarter as our non-iDose business continues its stents and everything else continue to stabilize. We would expect a low single-digit decline in the fourth quarter, so continue on that progress back to a more stabilized situation close to the LCDs that have impacted that part of the business earlier in the year. And we do expect continued growth obviously in iDose TR, although you may find implied in the guidance, it's tempered a little bit sequentially versus current trends just given many surgeons have full cataract schedules throughout the remainder of the year.

And it's a little early to start seeing the benefit from the NGS professional fee tailwind, and again, in general, this quarter is a bit of a tougher year-over-year comp from a growth standpoint. But I think what you'll find is that it continues to be largely all systems go across the majority of our business, with the one step back being really in the corneal health franchise as we transition there.

Okay, thanks. And then maybe just two follow-ups. Consensus for iDose for '26 is somewhere in the $220 million to $225 million range, I think. Anything you can express in terms of comfort or not there just so we can benchmark ourselves as we put preliminary numbers out there?

And then the second follow-up is on the trial timelines that you were talking about for combo cataract and MIGS plus iDose, can you give us a sense as to when those are going to read out and the ones that have read out, where they are?

I'll start and then let Tom comment on the trials associated with iDose continue to be ongoing. Really, Richard, as I mentioned earlier, I think we're going to stay with the broader guidance that we've given for next year of $600 million to $620 million. We'll talk a bit more on the constituent parts of that on the fourth quarter call. You referenced consensus on iDose. Clearly as we enter into next year, iDose is no longer the only, I'll call it, material variable that you all will be focused on and assessing, so I want to make sure that we talk about that in the same context and the same timing as we talk about our expectations for Epioxa in the corneal franchise throughout the year.

What I had said based on the earlier question was if you think about the third-quarter result of $40 million, we're at this point already on a $160 million run rate base began largely on the continued progress within the three MACs that have established professional fee coverage entering the quarter, that being Novitas, Meridian, and First Coast. So I feel good about the momentum in that part of the business and where it's heading and what that will mean for 2026, but we'll get more granular on the exact numbers. As we said, we'll update our guidance for the full year when we get on the fourth quarter call. Tom.

Yeah, I'd be happy to answer the questions. We're looking at two pretty major level-one Phase 4 clinical studies, and that's we'll look at iDose plus cataract versus cataract surgery alone, which we're currently enrolling. And as well, we're looking at a study that evaluates iDose plus infinite versus infinite alone. And so you can imagine the goals of both those studies will be to validate and to show the incremental advantage of using iDose in combination with cataract surgery and certainly iDose in combination with infinite versus infinite alone. These are important studies as we go forward, and really, they're both currently under enrollment.

It really will depend on when we choose to be able to show what length of data we want to show. And so I would prepare the investment community for a 2027 timeline, which would give us the ability to have really six months to a year of follow-up in each of these patients that we publish. And it may come as early as late 2026 if we choose to be able to terminate the study or I should say able to look at these patients at earlier time points. Typically, three months would be the earliest that I'd be able to publish. So I'd set your parameters to look at late 2026 or '27 with some very, very important follow-up clinical data for the use of iDose.

Due to time allotted for the question-and-answer session, we please ask you to limit yourself to one question. Thank you.

Mason Carrico, Stephens.

So in the context of Epioxa pricing, can you just remind us how the bulk of Photrexa volumes are billed today? Do you guys utilize the book-and-bill strategy with clinics and, if so, how much of your volumes rely on that?

Yeah, Mason, with Photrexa today we offer both buy-and-bill acquisition options as well as a specialty pharmacy. The specialty pharmacy option is something that we've really brought online primarily over the last couple of years, and that's been a growing percentage of the overall mix. But beyond that, I'm not prepared to disclose the exact mix between those, but I will say that specialty pharmacy has become an increasingly material portion of the overall acquisition mix.

David Saxon, Needham & Co.

Another one on Epioxa. Can you just talk about the cadence of getting coverage by commercial payers in 2026? I mean, if Photrexa will be phased out next year, how much coverage do you think you can end the year with, 2026 with? And then in terms of placing the new cross-linking machines for Epioxa, what's the strategy there for either upgrading or trading out the current installed base?

Yeah, David, I'll start on the capital equipment and establishing the site-of-care network. Epioxa does require a new piece of capital equipment, an O2N system that will be made available. We are already now, with the approval in hand, hard at work with customers to establish that changeover. As you might expect on a launch of this nature, we've got a variety of options for customers to acquire, to lease, and to swap out their existing equipment to make sure that the capital component is not an impediment to them getting into providing Epioxa as a therapeutic solution.

For the payer coverage side, you may recall on prior calls that we've been investing pretty heavily in this part of our organization alongside our field-based reimbursement team. That team is already hard at work, similar to establishing our site-of-care, but in this case with the payers around direct education efforts, meetings to make sure they understand what we've disclosed here today in terms of the therapy, its benefit to patients, engaging with those in the medical community to make sure they're educated around that, and ultimately trying to establish that coverage.

I think on the positive side, this is not the first launch in the category, and many payers already recognize that corneal cross-linking is the standard of care when it comes to arresting the progression of this sight-threatening disease. And from that standpoint, we need to educate them on the patient benefits of which there are many, as you heard Tom mention during his remarks as to the why behind the patient need to achieve access to Epioxa going forward. So that process is already well underway. We'll provide updates as we make our way throughout the year, but it's a little premature for us to establish benchmarks in terms of payer coverage expectations.

I am optimistic that when we engage in the conversation around the benefits we're providing to patients that are at the end of this that we'll move the needle as aggressively as we can with those payers to get that access going throughout the course of 2026.

Joanne Wuensch, Citibank.

I have many questions, but I’m going to try and stick to my one which is, when you gave guidance for 2026, what is included in that for Epioxa and what is included for iDose? I’m just trying to piece it all together because at that ASP, those numbers can ramp really fast.

As I mentioned before, I think we want to make sure that we were establishing an overall range for 2026 in light of the Epioxa approval and announcement and the number of moving parts. And for right now, I think I'll just leave it at what I said earlier that we’re confident in that range and we're confident there are a variety of paths that should enable us to meet those expectations. We’ll provide a lot more color on our fourth-quarter call around the individual constituent parts of that.

But you raise a totally valid and somewhat obvious point in that, with the wholesale acquisition cost and what that means in terms of relative to that, implied in there is a material step-down in the number of patients being treated with Epioxa in 2026 as we navigate all the things that I've already mentioned including getting the site-of-care network established, the miscellaneous code before establishing a J-code, and the time in which it takes to update the payers for that J-code in the second half. It will be a journey through the year of really getting the foundation underneath us so that we can be focused primarily on clinical care as we exit the year and head into 2027.

Michael Sarcone, Jefferies.

I was just going to try to ask the mix case for iDose in a little different way. Joe, when you think about your internal modeling and what you're expecting for iDose maybe over the next three years, the midterm range. How do you think about the mix of iDose performed in the standalone setting versus combo cataract?

I think that’s very surgeon-specific, and if you look even at the adoption we’ve had now, our highest-volume customers today do actually very little iDose in combination with cataract surgery. Clearly, as you make the product available in that wider arena, the lower-hanging fruit for some surgeons who primarily focus on cataract surgery is for them to be doing it in combination. And so I think in the intermediate term, some of that, quote-unquote, lower hanging fruit for that portion of the community could drive the mix a little bit closer to or a little bit more oriented towards the combo cataract setting. But certainly, as you get out into the three-, five-, and ten-year time horizon, the vast majority of it is interventional in nature, and standalone being the key driver of our long-term opportunity.

Anthony Petrone, Mizuho.

Maybe one on the follow-up discussion with the FDA on iDose reapplications. You mentioned in the prepared comments and materials for the third quarter that those discussions are still ongoing. So maybe just what is the latest there, and when do you expect FDA to make some sort of announcement on the supplement for iDose reapplications? And what is really the read-through of that element of the iDose story as we head into the CAC meeting on November 12?

Yeah. I’ll be happy to take the first part of that question. So just to reiterate, the PDUFA date has already been established by the FDA. It will be January 28 of this coming year, 2026. And we expect them to get an answer to our appeals to be able to add re-administration of the iDose device. As I’ve said many, many times before, we take a belt-and-suspenders approach to this. The reason we have iDose TRx already in a clinical trial and moving forward is to have the ability for surgeons to have a de facto exchange product available when their current implementations of iDose come to term in three-plus years.

And so we think we’re in great shape from that perspective. As I’ve said before, and I’ll choose my words carefully here, we are hopeful, but we’re not counting on the FDA giving us the nod to move forward with re-administration.

And it relates to the, I think, your second part of the question on the CAC meeting and some of the considerations around there, it’s actually, I think, a thoughtful question because it’s important to think about iDose as an FDA-approved pharmaceutical with a label and use that’s pretty similar to topical PGAs and other glaucoma medications. It’s different than a medical device, and I say that because what matters in an FDA-approved pharmaceutical is what the contraindications that are on with it. And currently, reimplantation is the primary contraindication for iDose TR.

It’s not whether it’s utilized in combination with cataract surgery, other MIGS devices, or heart medications for that matter. Today, iDose TR is approved with an open label that’s very similar to topical PGAs. If indeed, as Tom was talking about, we were to achieve that PDUFA date around reimplantation, that would bring to remove or at least modify that contraindication and certainly help us in terms of opening up that part of the market.

Danielle Antalffy, UBS.

I was at the AAO meeting a few weeks ago, and I felt like the takeaway from my (technical difficulty) looking for specific things, right, but was the focus on building out standalone MIGS practices. I attended a lunch session that was focused on that, and I’m curious about how you guys think the launch of iStent infinite into standalone is going, where you see standalone as a percent -- I'm not asking iDose, right, I'm asking for the MIGS patient population here, where you see standalone MIGS going over the next three to five years?

And what are the sorts of logistical things with practices that you think need to happen in order to enable continued growth in that market?

Yeah, Danielle. I think it's a great question and a good one here as we're wrapping up this conversation. I mean, everything that we’ve been doing for a couple of years now and certainly as we're moving forward is around driving that standard of care toward interventional glaucoma and acting on behalf of these patients. And so from that standpoint, it doesn’t surprise me, although I’m always happy to hear that as you were doing your checks at AAO that you heard that same thing.

Anytime you have a profound standard-of-care shift, there are logistical hurdles, but the first one you have to get through is the clinical component of this and the clinical buy-in from the community. And you've heard us say it before, but I'll reiterate it, we couldn’t be more happy with the receptivity from the physician community around the need to act on behalf of these patients in an interventional way. And whether that tool is iDose, whether that tool is iStent infinite, or any of the other things that might be part of their toolkit, if you will, in trying to tackle this sight-threatening disease, it’s encouraging to hear they continue to move forward.

But on the logistical side, it does change things. It’s changing the education of the optometry referral community, it's changing the scheduling blocks, it's changing the time and allocation of that time within their OR time, their surgery centers, and the like. There’s a lot that goes into this over time. It’s about establishing proper reimbursement and market access for the various tools that are there to treat patients the way you wanted to treat them by the surgeon or physician. So each one of these things play themselves out, and none of them are overnight success stories. Each one of them (inaudible) progress every day, every week, every month, and every year.

And I think it’s why we look at this over a 3-, 5-, or 10-year period, we're so optimistic about where this is all heading because it’s all rooted in the right paradigm shift of clinical care. The rest of it, we have to keep our heads down and keep executing against that. And if we do that, if you’re talking about a market opportunity, as you've heard me say many times, there are 21 or 22 million eyes in the United States with ocular hypertension or glaucoma, 12 to 13 million of those eyes today are already being actively treated, maybe imperfectly in the form of topical eye drops, but they’re being treated. You compare that to what we’re talking about in the earlier days of combination cataract and MIGS, where you had about half a million eyes.

So when we look at this over a prolonged period of time, we expect that the vast majority of procedures, irrespective of the tool, to be done in that standalone interventional glaucoma market surely because of the relative size of those market opportunities and the clinical need for that.

Thank you. And with no further questions in queue, I would like to turn the conference back over to the company for closing remarks.

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

This concludes today’s conference call. You may now disconnect.