GLAUKOS Corp Q1 FY2026 Earnings Call

Welcome to Glaukos Corporation's First Quarter 2026 Financial Results Conference Call. Copies of the company's press release and quarterly summary document, both issued after the market close today, are available at www.glaukos.com. This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will 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, Joe Gilliam; and CFO, Alex Thurman. Similar to prior quarters, the company has posted a document on its Investor Relations website under the Financials & Filings, Quarterly Results section tied with Quarterly Summary. This document is designed to be read by investors before the regularly scheduled quarter conference call. 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, product, 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 Investor Relations section of our website at www.glaukos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available on the Investor Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos' Chairman and CEO, Tom Burns.

Okay. Thank you, Chris. Good afternoon, and thank you all for joining us. Today, Glaukos reported record first quarter consolidated net sales of $150.6 million, up 41% on a reported basis and 39% on a constant currency basis versus the year-ago quarter. As a result of our first quarter outperformance, we are raising our full year 2026 net sales guidance to $620 million to $635 million compared to $600 million to $620 million previously. Our first quarter results reflect strong execution across our global commercial and development priorities, highlighting the commitment of our teams, strength of our differentiated technology platforms and our continued progression as an increasingly diversified leader in ophthalmology. Looking ahead, we believe we are well positioned to sustain this momentum driven by two transformational growth drivers, including the continued advancement of the interventional glaucoma treatment paradigm with iDose TR and the launch of Epioxa, establishing a new standard in interventional corneal care and rare disease treatment. Together, these compelling and durable market opportunities reinforce our confidence in delivering a best-in-class growth profile 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 to support our near-term objectives of continued operating leverage and cash flow breakeven. Now let's discuss our first quarter results in more detail. Within our U.S. glaucoma franchise, we delivered record first quarter net sales of $93.5 million on strong year-over-year growth of 58%, driven by growing contributions from iDose TR, which generated sales of approximately $54 million in the first quarter. iDose TR continues to deliver strong clinical outcomes that meaningfully improve patients' lives, driving strong physician interest and adoption. From an execution standpoint, we remain focused on our key initiatives, including expanding our base of trained surgeons and active accounts, increasing utilization, broadening market access, scaling targeted commercial investments and expanding the body of clinical evidence. On the last point, iDose TR is supported by a robust and growing body of clinical evidence demonstrating strong efficacy, safety and durability of effect. This now includes 22 peer-reviewed publications, complemented by a broad portfolio of active Phase IV studies across diverse real-world clinical settings, further reinforcing its consistent performance in real-world practice. Importantly, iDose TR is serving as the foundation for a broader shift towards earlier intervention in glaucoma care. Our efforts to educate surgeons and key opinion leaders globally are gaining traction and helping to drive a steady evolution in the standard of care. This momentum was evident at recent major industry meetings, including AGS and ASCRS, where engagement and enthusiasm around interventional glaucoma and our novel therapies were notably strong and growing. To support these efforts, we continue to invest in our commercial organization and infrastructure to expand disease awareness and education, while enabling our customers to effectively adopt and operationalize interventional care into their clinical practice. Moving on, our international glaucoma franchise delivered record net sales of $35.8 million and year-over-year growth of 23% on a reported basis and 16% on a constant currency basis. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive our mix forward as a standard of care in major markets around the world. As previously discussed, we continue to expect competitive product trialing headwinds in some of our major international markets as we progress through 2026, partially offset by growing contributions from iStent Infinite following its EU MDR certification and associated European commercial launch late last year. We also expect the currency tailwinds to abate going forward based on the current rate environment. And finally, our Corneal Health franchise delivered net sales of $21.3 million on year-over-year growth of 15%, including Fetrexan and very early Epioxa sales of $17.7 million. At the end of the first quarter, we are delighted to announce commercial availability of Epioxa, our novel, groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare corneal disease that is currently far too often underdiagnosed, undiagnosed and untreated. We believe Epioxa represents a transformative innovation in corneal care, offering an incision-free alternative to traditional corneal cross-linking procedures, and it does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. This novel oxygen-enriched topical therapeutic, bioactivated by UV light, is designed to reduce the pain associated with removal of the epithelium, streamline the procedure and minimize recovery, all while delivering clinically meaningful outcomes and exceptional value to patients, providers and the health care system. The response we received from surgeons in the broader ophthalmic community since FDA approval and the more recent initial commercial launch activities has been very encouraging. As we've discussed, with the launch of Epioxa, we have redefined our go-to-market approach to better address the sight-threatened disease and truly expand patient care and access. Importantly, with this launch, we are substantially increasing 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. As with all pharmaceutical launches, initial patient access will be gated by typical payer adoption headwinds, but we've been encouraged by the progress we've made in the short order through the early days of our launch. First, I'm proud to report that we have successfully established and continue to selectively expand a broad-reaching site-of-care network. Our acquired O2N systems are already actively deployed across locations serving roughly 65% of the U.S. population with the pipeline progressing through various approval processes that we expect will expand our treatment center reach to approximately 95%. 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, we continue to make considerable progress with payers to secure access pathways or policy coverage for Epioxa with several plans having already updated or are in the process of updating their policies to include this novel therapy. These efforts are translating into expanded access with pathways now established for more than 100 million covered commercial lives in the United States, including with four of the five largest payers, reflecting encouraging initial receptivity of Epioxa's clinical value. While we expect the pace of policy adoption to build over time, we remain focused on driving broader coverage across both commercial payers and Medicaid programs to support more streamlined access pathways over time. Earlier this month, we achieved another important market access milestone as CMS has signed a product-specific J-code for Epioxa, consistent with our expectations and in response to our application. The new code J2789 is scheduled to take effect on July 1, 2026, and we believe it will help streamline the reporting and reimbursement process for Epioxa among U.S. payers over time. 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 and solidified operationally by providers in our specialty pharmacy. Beyond market access, we're proud to lead the way once again in forging a new path for interventional care to come by advancing targeted marketing and DTC initiatives to drive awareness, education and earlier detection, supported by greater optometric engagement and strengthened advocacy partnerships. Finally, we launched a co-pay assistance program for eligible patients and are operationalizing a specialty pharmacy partner network in support of Epioxa patients. As you can see, we are very excited by the significant potential Epioxa offers to patients living with keratoconus. While Epioxa remains in the early stages of its launch, our teams are energized and executing with focus, and we're encouraged by the solid progress we're making against our core launch priorities. Beyond Epioxa, we continue to advance a broad and differentiated clinical pipeline across our five novel therapeutic platforms encompassing 13 publicly disclosed programs and additional undisclosed assets supported by a robust portfolio of active clinical and Phase IV studies. This includes ongoing pivotal trials for iDose TREX, iStent Infinite in mild to moderate patients and the PreserFlo MicroShunt, an active Phase II trial for iLution Demodex blepharitis, ongoing development for our Link platform, including a planned market introduction of our KC screening device late this year and our promising earlier-stage retinal assets. Overall, we remain on track with our clinical timelines and encouraged by the progress across our complete portfolio. In conclusion, at Glaukos, we're in the business of pioneering new marketplaces within ophthalmology for the benefit of patients. Our record first quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified industry leader with multiple transformational growth drivers in iDose 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?

And our first question comes from the line of Tom Stephan with Stifel.

Great. Thanks for the question. Nice quarter. First one on Epioxa, Tom or Joe, maybe if you can talk about early findings: one, on sort of how initial experiences in the claims and prior authorization processes are going; and two, what demand in the market looks like from an early utilization standpoint, maybe based on what you're seeing in the Epioxa patient portal? And then I'll have a quick follow-up.

Sure. Thanks, Tom. It's Joe. I'll start off there. I think Tom gave you some of the higher-level stats on the progress we're making with the Epioxa launch, both in terms of two fundamental foundational items: our site-of-care network as well as the broader payer pathways. Underlying that, which I think you're asking about, is the process of making your way through that. Clearly, it's hard to judge too much on that until we get into the post J-code period because at this point you're dealing with the miscellaneous code. So all systems around that, by definition, are slower than normal as you adjudicate on a claim-by-claim basis. But I will say that we've been very encouraged by those sites of care who come online, as Tom referenced, and the patient flow that's coming from that into our portal and hub, which we view as a leading indicator of what it can mean for clinical demand associated with an epi-on therapy like Epioxa. As we make our way through that and we see those claims get adjudicated — we've seen positive claims get through the process and also those procedures get done now — we're encouraged by that funnel as it develops.

Got it. That's great. And then follow-up just on iDose, really solid quarter. Joe, maybe to stick with you, can you just talk about drivers of the strength? And it'd be great if you could also discuss kind of Noridian and Novitas versus the remaining MAX and what you're seeing in each of those two pools, if you will?

Yes, absolutely. I think the most encouraging thing about the results of the first quarter was it was very broad-based in terms of what drove that performance. It was continued expansion within the more established MAX — and you referenced Noridian, Novitas, and First Coast in that as well. I'll come back to that. But now you start to see NGS, in particular, turning on, the early signs of Palmetto turning on as well as we've more recently achieved a professional fee formally in that region. I think also encouraging was a real increase in the funnel into our hub associated with commercial and Medicare Advantage patient flow. So it was broad and consistent with what you would hope to expect in the context of our core initiatives. To put a finer point on it, I think on your question around Noridian, Novitas, typically I talked about that in the context of Noridian plus Novitas and First Coast as some of the earlier adopting MAX. In the first quarter, that was down to about 7% of the overall region volumes from 78% in the fourth quarter. Again, that's really because as they continue to grow, you might expect adoption curves to be picking up even faster in areas like NGS and Palmetto.

Our next question comes from the line of Adam Maeder with Piper Sandler.

Congrats on a great start to the year. First one for me, I wanted to ask a modeling question. So nice Q1 top line, you raised the full year outlook by more than the Q1 outperformance. You've given a lot of great modeling color in the past. So Joe, maybe for you or Alex, can you pull apart the updated guidance with iDose contribution versus the stent business versus Corneal Health and as we think about Q2 in particular and as it relates to Epioxa? I would appreciate a little bit of modeling help. And then I have a follow-up.

Sure, Adam. I'll dive in and give some introductory comments on that front. As you said, it was a great start to the year with each of our franchises exceeding expectations, and we made considerable progress across all those fronts, including within interventional glaucoma and iDose in particular. As a result, we were able to raise our guidance up to the $620 million to $635 million range. As you think about that in your models by franchise, on the international glaucoma side, the dynamics here are somewhat unchanged. We expect, as we move forward, some of the currency benefits Tom called out in the prepared remarks to moderate. We expect going forward to see sort of high single-digit growth for the remainder of this year in international glaucoma, translating into low double-digit growth for the full year, with single-digit growth in the remaining quarters. On the Corneal Health side, there are a fair number of moving parts. It was a strong first quarter, but we continue to anticipate volatility associated with both the TREX and Epioxa transition, and also the temporary to permanent J-code transition over the course of Q2 and Q3. Taken together, we now expect kind of high single-digit growth for this franchise for the entire year, with puts and takes in individual quarters. As I've said before, we expect to be exiting the fourth quarter with a pretty strong performance curve as we start to pull through Epioxa in a more meaningful way. On the U.S. glaucoma side, another strong start to the year, we would adjust our view there to be more in the low-30s growth for the full year, driven by an ongoing view that we should expect kind of flattish non-high-dose sales going forward until proven otherwise and continued sequential progress with the iDose launch. So you put that all together, and we raised our overall guidance and clarified the underlying franchise drivers. For Q2 in particular, given there is a lot going on, for the U.S. glaucoma franchise, we expect flat non-iDose and continued sequential iDose expansion. For interventional glaucoma, expect high single-digit growth as that benefit continues. For the corneal side, we expect a bit of a dip year-over-year in Q2 as we transition from Photrexa to epi-on approaches.

Really appreciate all the color, Joe. If I could just sneak in a follow-up: wanted to ask about iDose and whether you've reached a point now where you have critical mass from a reimbursement standpoint. Tom or Joe, can you talk about new initiatives you're going to put in place? I think you've talked about growing the commercial team and potentially looking at direct-to-consumer as we get into the latter part of the year. Some incremental color on the next chapter would be helpful.

Yes, you're exactly right, Adam. We've always said you don't want to put some of these things into place until you start to have a more solid foundation from a reimbursement standpoint. What you're hearing in the context of our first quarter results and our guidance is increasing confidence in that foundation, both in terms of five of the seven MAX that are now stable with professional fees and the team driving incremental confidence on the reimbursement side as well as the clinical and commercial side. Also, increasingly as we move forward, broader commercial Medicare Advantage is contributing. As we've discussed in the past, as we move forward it's about driving increased awareness for iDose and interventional glaucoma and the teams that help drive that broader environment of both patient education and the process to get them treated by an interventional procedure like iDose. We have been making significant investments for some time in our reimbursement and business teams that surround the traditional sales force to maximize patient access and support broader awareness initiatives. You should expect to see more of that as we get into the second half of this year and as we exit the year and head into next, based on this trajectory, where we'll feel more confidence in making more offensive investments.

Next question comes from the line of Larry Biegelsen with Wells Fargo.

Congratulations on a strong quarter. Maybe one on iDose and one on Epioxa. Joe, if you could talk about how you've engaged with the MAX since the CAC meeting last year: any updated thoughts on the likelihood of an LCD this year and the timing of those two RCPs you're running? I had one follow-up.

Yes, I'll start with the beginning, and Tom can comment on the broader studies. As we think about engagement with the MAX, we haven't changed our approach: we've engaged in an education process to make sure they understand our technologies, how to utilize the labels and indications for use around them. We continue to identify where we have ongoing less streamlined reimbursement in areas like CGS and WPS, and we continue to have momentum in those conversations. Hopefully we're marching forward on those two MAX in a productive way so they can drive professional fee establishment similar to the other five larger MACs that have come before them. As it relates to the post-CAC LCD conversation, no changes since our last call. At this point we've not seen any signs of an LCD, and we continue to believe it would be premature at this stage of the clinical adoption curve. Having said that, these things can be unpredictable, so it's certainly possible even if we believe it's less probable.

To address your question on Phase IV studies, Larry, we've contemplated and have been enrolling for some time. Once we received NDA approval, we began two major Phase IV studies. The first is iDose plus cataract versus cataract surgery alone to demonstrate the incremental value of using iDose in combination with cataract surgery. That study is fully enrolled, and we'll be following those patients over the course of this coming year and looking to publish the data at regular intervals. I think that will be a very powerful supplement to the data we currently have on hand, again, alongside the 22 peer-reviewed clinical trials. The second study is looking at iDose versus iDose plus iStent Infinite to show the incremental value of these two different mechanisms of action at lowering intraocular pressure to very low target pressures. With both of these in hand, I think they will be timely should we be challenged in the future by any payer, by showing the value of combination modalities or procedural pharmaceuticals plus MIGS, or using iDose in combination with cataract surgery.

One other thing I'll add, Larry, even at a minimum these studies Tom referenced are important for the broader payer community. This is how you continue to expand coverage irrespective of MAX and LCDs, with individual commercial players and Medicare Advantage plans to optimize access for patients.

For my follow-up on Epioxa, Joe, more of a big picture question: from our past conversations you felt confident that Epioxa could return to peak Photrexa levels of roughly 18,000 to 19,000 eyes by the end of the decade. If that's paid volume, that would be well north of $1 billion in revenue. How are you feeling about achieving that, and what does the ramp look like?

Yes, Larry, I won't stop short of making long-term predictions formally, but we've been on record saying we view this as a potential $1 billion-plus franchise. The pace at which we get there we'll continue to monitor as we enter true commercialization, especially in the second half of this year. Part of that is that we don't view it just in the context of where we've been with Photrexa patient volumes. We're making significant investments to drive increased awareness, detection, action and access in hopes of treating far more than past volumes. We believe there are more than the 18,000 to 19,000 eyes at any given time that should be diagnosed and treated. The DTC and other investments Tom referenced will be put toward growing the overall market from a volume perspective over time and getting more of these patients treated.

I'd add that over our planning period, there are possibilities to build the marketplace beyond the initial launch, including second-generation customized algorithms for treatment that could demonstrably change K-max for patients, potentially improving best-corrected visual acuity. If we show those benefits, it could expand the market considerably and potentially provide a second wave of growth into the 2030s, increasing our presence in this disease.

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

Congrats on a strong start here. Dovetailing on prior questions: there's been investor concern about LCD risk. Tom, could you talk about the existing body of evidence in contrast to the Phase IV studies, and remind us what percentage now have iDose used in combination with cataract or another MIGS? If some studies already bear out combinatorial usage, is the Phase IV really necessary to refute concerns?

I'll start. The trends remain consistent with past commentary. The relative percentage of procedures where surgeons treat glaucoma with iDose in conjunction with cataract is growing as expected; Glaukos has influenced the standard of care for those patients. At the same time, we remain focused on interventional glaucoma and continue to see rapid growth in the number of standalone iDose procedures. Last year the majority were standalone, but the mix is shifting toward combination with cataract or another modality. Surgeons are combining therapies to further slow disease progression.

Most of the Phase IV studies we're doing are for payers and to support commercial payer and Medicare Advantage coverage. Surgeons already have confidence in using iDose in combination with cataract surgery or with iStent Infinite. The studies are less to convince surgeons and more to validate and document outcomes for payers to support broader access.

Understood. Second, for Joe and Alex: operating expense guidance and thoughts on profitability. It seems you could become profitable in the next year. How do you think about the ramp in expenses needed for the Epioxa commercialization and what that does to timelines to profitability in our models?

Ryan, it's Alex. I'll start with profitability. To reiterate what Tom mentioned, our near-term focus is managing the business toward cash flow breakeven and driving operating leverage within the P&L, which we saw in the first quarter. As we look ahead, we can see a fairly clean line of sight toward that pathway over the next few years, though it depends on the ramp of commercial launches and associated revenues. We continue to manage toward cash flow breakeven while reinvesting in commercial launches. Operating expenses will grow year-over-year; we had planned that. After overachieving in Q1, Tom, Joe and I have discussed adding additional fuel to these launches. You should see operating expenses tick up slightly and modestly from earlier expectations, but still in the high teens growth and showing operating leverage as we progress through the year.

Ryan, when you hear Tom and me talk about incremental spending for DTC or otherwise, much of that is discretionary. We'll make those investments alongside the significant growth we're achieving, and we expect to evaluate the effectiveness and ROI of those efforts before diving in fully. We've been disciplined historically and intend to be disciplined going forward.

Next question comes from the line of Allen Gong with J.P. Morgan.

Thanks. Wanted to start on the core U.S. glaucoma business. iDose had a really strong quarter, but underlying U.S. glaucoma did better than expected and grew at a healthy clip. When I think about your forecast, your reiteration for flat for Q2 and the year, what supports that outlook? Is it conservatism or real challenges in the market?

Allen, you're right this was the second straight quarter where we've seen a restoration of growth in non-iDose core U.S. glaucoma. We've seen signs of stabilization in that market and our teams are executing well. But we don't want to call that the new normal after only two quarters; it's encouraging but we prefer to be conservative until sustained. There were some supply chain disruptions on the competition front that may have benefited us a bit in the quarter; it's hard to measure and likely not material and should subside. We want a couple more innings of data before changing our views.

Got it. Follow-up on Corneal Health: you talked about reaching coverage of 65% of the U.S. population with line of sight to 95%. How quickly can you get to 95%? By year-end or slower?

In some ways it's been accelerating since commercial availability and the transition plan became real. What we've seen is acceleration rather than deceleration. That said, hospital systems and some customers have longer cycles to bring on new technologies. We'll continue to make substantial progress every month and hope to be close to that target in realized site-of-care network reach by year-end.

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

Could you talk about specific market development efforts underway for Epioxa, broken into physician and practice education, patient assistance programs, and engagement with payers?

Sure, David. Think of it this way: foundationally, you get the site-of-care network established, trained and ready. The second layer is engaging payers to establish access pathways and then streamlining and optimizing those. Alongside that, you dial up physician- and patient-related marketing efforts, but you don't do that too early until the ecosystem is ready. Right now much of our work is ensuring the site-of-care network, hub, specialty pharmacy, and co-pay assistance machinery are operating efficiently so patients can get access. That work can be lengthy under a miscellaneous J-code. We're encouraged by the initial patient flow and are focused on getting them on therapy as claims get adjudicated before the formal J-code takes effect in the second half.

Helpful. Follow-up on iDose: you talked about readministration approval early in the quarter. Has that contributed meaningfully? How should we think about readministration and TREX longer term?

We have seen numerous successful readministration procedures as early patients reach the appropriate timeline. It's still a small fraction of procedures but multiple surgeons have performed readministration successfully. We've seen payer policy updates and general progress there. As initial benefits of the implant wane, patients and providers will want to continue therapy; we're seeing that begin. Over the long run readministration will become a more material portion of the mix, increasingly relevant each quarter.

Your next question comes from Richard Newitter with Truist Securities.

Congrats on the quarter. On Epioxa, what's happened to the provider base as the transition is taking place? Will there be a concentration in a small number of providers early on to refine processes, or will it be broader?

Good question. Historically with Photrexa you had a relatively concentrated group of centers and sites doing procedures. With Epioxa our intent was to make the initial site-of-care network concentrated enough to be close to most of the U.S. population. Our Wave 1 efforts have been targeted and, in some respects, have gone very well, causing us to accelerate investments to meet demand. There will be early adopters and later adopters as in any launch. I'm not concerned about significant concentration in a small number of customers; it will be measured in hundreds of customers ultimately rather than single digits.

That's helpful. Is there any one area where the stepped-up offensive spend is being directed based on early learnings? Where are the frictions most notable — physician reluctance, payment process, or patient demand awareness?

A lot of the spend is going to initial lift around claims prosecution and adjudication. There's always education for sales and broader teams, and in the future more spend toward growth and DTC. Right now the focus is much more on ensuring the mechanics in market access work efficiently: helping customers with prior authorizations, supporting the hub and specialty pharmacy processes, and ensuring our co-pay assistance programs operate as intended. That operational work is critically important to ultimate success.

Your next question comes from the line of Harrison Parsons on behalf of Mason Carrico with Stephens Incorporated.

Would you provide color on utilization across cohorts of surgeons trained on iDose? Is there a portion of the surgeon base that has matured with stable utilization, or are you seeing robust utilization growth across older cohorts too?

Harrison, I wouldn't say we're at stabilization for any cohort. Even early adopters continue to refine how they manage interventional glaucoma, time allocation, and patient mix. We're still seeing growth across both mature customers and new surgeons. We're early in the overall evolution curve of this launch.

Got it. Second question: update on commercial payer progress for iDose. You had said more than 50% of Medicare Advantage and commercial policies had a positive policy in place mid last year. Where does that stand today?

It hasn't changed materially this past quarter. As of today, about 99% of patients have an access pathway in the commercial and Medicare Advantage arena. About 50% of those patients are in plans with a specific policy and the remainder where there's silence we're seeing successful pull-through. In the early days of our efforts we are seeing a very high success rate for prior authorizations submitted for these patients, which is consistent with the access pathways I just described.

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

Congrats on the quarter. On the specialty pharmacy channel and RCM: physicians doing Epioxa were previously doing buy-and-bill with Photrexa. What's the feedback on process changes and any friction with the new workflow?

David, historically some customers preferred buy-and-bill for Photrexa and others used specialty pharmacy. Among non-hospital-based customers the vast majority out of the gate are choosing to access the drug via our specialty pharmacy. That means some are using that channel for the first time. It's early to comment definitively because under a miscellaneous code, even with streamlined hub and specialty pharmacy processes, getting access for the patient is elongated. The drug has been on the market for a month, so we're still in early adjudication stages. We're encouraged by the work our specialty pharmacy partner has done to be in network with plans, and ultimately that will benefit customers who choose that channel.

Great. Quick follow-up for Alex: group gross margin outlook and how to think about gross margin as iDose and Epioxa scale into next year?

Thanks, David. We saw 84% gross margin in the first quarter, up 120 basis points year-over-year, which we were pleased to see. In the last call I gave a range for the year of 84% to 86%, and we continue to feel comfortable with that guidance, with expected accretion over the course of the year as products like Epioxa become a greater share of the mix. Looking into 2027, you would expect further accretion as these products ramp, and we'll comment more as we get closer.

Your next question comes from the line of Michael Sarcone with Jefferies.

Thanks for squeezing me in. Follow-up on Epioxa specialty pharmacy: when you think about buy-and-bill, understanding specialty pharmacy is coming first, can you talk about options you're evaluating to enable buy-and-bill for Epioxa down the road?

Michael, I won't go too far into details, but there's an ongoing education process from our reimbursement teams and site-of-care teams to make sure customers understand how buy-and-bill would work, the terms and conditions related to payment terms, and other elements needed to enable it where customers choose that path. From a business standpoint, buy-and-bill can be attractive when the right building blocks are in place.

Quick follow-up on iDose Trio: what's the latest timeline and status?

Happy to address that, Michael. We've completed the clinical study for iDose Trio and we are monitoring those patients over the course of this year. We plan to file by the end of this year and expect to be in position for targeted approval in the fourth quarter of 2027. We're on track. Our human factors analysis showed a strong preference for the new design — roughly 90% — and we're encouraged about the potential to support increased in-office use over time.

Your next question comes from Joanne with Citigroup.

Can you hear me okay?

We can.

When we do due diligence on iDose, physicians sometimes push back on the price tag. I'm a little confused since you have the J-code and reimbursement in place. What's your initial read on this and how have physicians responded?

Joanne, you'll always have customers with varying views on value and pricing, but that's not a material driver today as it was when we launched. Anytime you launch a pharmaceutical there is a period where customers need to understand the product and the why and how. For the vast majority of customers, uptake continues and we continue to add accounts and drive adoption. We can overcome that challenge where it exists.

Your next question comes from the line of Steven Lichtman with William Blair.

A couple quick ones on Epioxa: as it relates to the transition from Photrexa, are you still anticipating Photrexa to fully sunset by the end of Q3? Any change in that plan?

No change. Consistent with our communications, we expect the transition in the third quarter. Photrexa will be available in limited quantities through a different mechanism for physicians who require an epi-off-based procedure thereafter, but I wouldn't call that material for the commercial aspects; it's a pathway for physicians who need ongoing access.

Longer term, potential for expanding these platforms outside the U.S., for Photrexa or Epioxa?

International expansion needs to be selective. There are certainly markets that can support these therapies, but with reference-based pricing initiatives and payer dynamics, we'll evaluate carefully. It's not something to factor materially into near-term models at the moment.

Our final question comes from the line of Anthony Petrone with Mizuho.

Congrats on the quarter. On keratoconus broadly: it's underdiagnosed and many patients present with Stage 2 severity. What is the true TAM in the U.S.? Is prevalence more like 80,000 to 100,000 patients? What's the diagnostic pathway to get more patients into the funnel?

Great question. We believe the 18,000 to 20,000 eyes treated historically is a fraction of what should be diagnosed and treated. Our estimates suggest between 50,000 and 100,000 keratoconic eyes per year at a minimum could be diagnosed and treated with corneal cross-linking. We expect to find that number out as we push increased detection and awareness initiatives and improve access. Over time this condition could be seen more as underdiagnosed rather than rare, but today it operates like a rare disease and we will invest accordingly.

With no further questions in queue, I will now hand the call back over to Glaukos Corporation for closing remarks.

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

Thank you again for joining us today. This does conclude today's conference call. You may now disconnect.