Glaukos Corp Aktie

Welcome to Glaukos Corporation's Third Quarter 2026 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.

[Operator Instructions] 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 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 only one question. If you still have additional questions, you may get back into the queue.

Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations.

These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.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. Today, Glaukos reported record third quarter consolidated net sales of $211 million, up 58% versus the year ago quarter. As a result of our third quarter outperformance, we are raising our full year 2026 net sales guidance to $775 million to $785 million, an increase of $90 million at the midpoint over our prior guidance of $680 million to $700 million.

We are also introducing highly preliminary 2027 revenue guidance of $1 billion. This preliminary outlook factors in our expectations as it relates to the continued commercial rollout for Epioxa and iDose TR, the surgical MIGS landscape and our International Glaucoma franchise. We expect to refine this guidance range and provide additional commentary as appropriate in the future.

Our record third quarter results reflect strong performance across our global commercial and development priorities, underscoring the successful execution of our teams, the strength of our differentiated technology platforms and our continued evolution as an increasingly diversified leader in ophthalmology.

Looking ahead, we believe we are well positioned to sustain this momentum driven by 2 transformational growth drivers, including the further advancement of the interventional glaucoma treatment paradigm with iDose TR and the launch of Epioxa, establishing a new standard in interventional keratoconus and rare diseases.

Together, these compelling and durable market opportunities reinforce our confidence in our ability to deliver a best-in-class growth and margin profile well into the next decade.

We are also encouraged by the tremendous progress across our P&L in the third quarter, reflecting the increasing scale and diversification of our business. Highlights included nearly 400 basis points of year-over-year non-GAAP gross margin expansion to approximately 88%, continued operating leverage, more than $50 million in cash generation, $28.5 million in non-GAAP net income and non-GAAP earnings per share of $0.47.

While we believe our business is increasingly well positioned to deliver sustained cash generation and profitability as we scale, we remind investors that our primary focus remains on maximizing near- and long-term revenue growth and capitalizing on the significant opportunities in front of us.

Accordingly, we remain committed to investing strategically across our industry-leading pipeline, commercial infrastructure and market development initiatives to advance our innovative platforms, expand our addressable markets and drive sustained top line growth. We will continue to manage the business thoughtfully, balancing these strategic investments with disciplined expense management, capital allocation and a focus on operational efficiency.

Ultimately, we believe this approach best positions us to bring transformational therapies to patients, strengthen our financial profile and drive sustainable, substantial long-term growth and shareholder value.

Now let's discuss our third quarter results in more detail. Starting with our Corneal Health franchise, we delivered record third quarter net sales of $59 million on robust year-over-year growth of 154%, driven by Epioxa net sales of approximately $53 million. We remain very encouraged by the early progress of our commercial launch of Epioxa as the first and only FDA-approved epithelium-on corneal cross-linking therapy for keratoconus.

Epioxa has generated strong interest from surgeons in the broader ophthalmic community, reinforcing our confidence in its potential to redefine the treatment paradigm for this rare sight-threatening disease, which we believe remains significantly underdiagnosed and undertreated.

Our launch priorities remain centered on expanding patient access, building awareness, optimizing referral networks and driving earlier diagnosis. We continue to make meaningful progress across each of these areas, supported by the ongoing expansion of our site-of-care network, growing market access and continued development of our specialty pharmacy and patient support infrastructure.

First, we have successfully established and continue to selectively expand our broad-reaching site-of-care network. Our acquired O2N systems are already actively deployed across locations serving roughly 90% of the U.S. population, with the pipeline progressing through various approval processes that we expect will expand our treatment center reach to more than 95%.

Next, we continue to make considerable progress with payers to secure access pathways and policy coverage for Epioxa with access pathways now established for approximately 90% of commercial lives in the United States, including through the 5 largest payers and more than 80% of Medicaid lives, reflecting encouraging receptivity of Epioxa's clinical value.

We remain committed to securing access pathways with the remaining smaller and regional plans as we increasingly focus on pathway optimization and improving the time to treatment for patients. Following the July 1 effective date of Epioxa's product-specific J-code, J2789, we made encouraging progress during the third quarter in optimizing the operational processes, supporting reporting and reimbursement. We remain focused on working with providers and our specialty pharmacy partner to further refine these workflows and facilitate a more efficient and predictable reimbursement process for Epioxa.

Clinically, we continue to be encouraged by physician feedback and the outcomes they are seeing with Epioxa in practice. These real-world clinical observations are consistent with the positive results from our recently announced 3-year Phase III extension study, which demonstrated sustained improvements in corneal shape, meaningful visual acuity gains and a favorable long-term safety profile following a single Epioxa treatment.

Together, these findings further reinforce Epioxa's potential to provide durable clinical benefits for patients living with keratoconus and meaningfully advance the treatment paradigm.

During the third quarter, we took another important step in our efforts to expand the keratoconus market with the launch of our Could it be KC? disease awareness campaign in partnership with NBA champion, Stephen Curry. Stephen's personal experience living with keratoconus, combined with his extraordinary platform and reach, gives us a unique opportunity to increase awareness of this underdiagnosed disease and to drive earlier detection and diagnosis.

We view this as an important long-term investment in the KC market and an important component of our commitment to addressing the significant unmet need across the keratoconus care continuum with additional campaign activities planned for 2027.

Complementing these efforts, we remain focused on deepening engagement with the optometric community, which we believe plays a critical role in identifying and referring patients with keratoconus. We remain on schedule to launch our KC screening device as we enter 2027, which we intend to leverage to raise disease awareness, facilitate more accessible screening and diagnosis and to enable earlier identification of patients who may benefit from treatment.

Together with our broader disease awareness initiatives and strengthened advocacy partnerships, we believe these efforts position us to meaningfully advance the KC care continuum and expand patient access to treatment.

Finally, we continue to enhance and optimize our patient and physician support services, including our co-pay assistance program to eligible patients to help facilitate access to Epioxa and to support patients throughout their treatment journey.

While we still remain in the early stages of the launch, we're encouraged by the solid progress we're making against our core launch priorities and remain very excited by the significant potential Epioxa offers to KC patients.

Moving on. Our U.S. Glaucoma franchise delivered record third quarter net sales of $118.6 million on strong year-over-year growth of 47%, driven by growing contributions from iDose TR, which generated sales of approximately $76 million in the third quarter. iDose TR continues to deliver strong clinical outcomes that meaningfully improve patients' lives, resulting in strong physician interest and adoption while helping to accelerate a broader treatment paradigm shift towards earlier interventional glaucoma care.

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 robust body of clinical evidence supporting iDose TR.

To that last point, we recently announced positive top line results from our Phase IV randomized controlled trial evaluating iDose TR in combination with cataract surgery. The study achieved its primary endpoint, demonstrating statistically significant superiority in a clinically meaningful IOP reduction compared to cataract surgery alone with an 11.1 millimeter mercury mean reduction in IOP and a 3.6 millimeter mercury incrementally superior treatment effect at 3 months. These results further strengthen the extensive body of clinical evidence supporting iDose TR's efficacy, durability and safety while reinforcing the versatility of the therapy across different treatment settings.

Additionally, we continue to monitor developments related to the proposed local coverage determinations for iDose TR. We have engaged in the process to ensure the therapy is appropriately understood within the Medicare coverage framework while preparing for a variety of potential outcomes. We believe the strength of iDose TR's clinical evidence, real-world outcomes and broad stakeholder advocacy supports appropriate Medicare coverage that preserves physician decision-making and patient access.

And finally, our International Glaucoma franchise delivered net sales of $33.4 million on a year-over-year growth of 13% on a reported basis and 15% on a constant currency basis. The strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plan to drive MIGS forward as a standard of care in each region and major market in the world.

Shifting to our pipeline. We continue to advance a broad and differentiated clinical pipeline across our 5 novel therapeutic platforms, encompassing 14 publicly disclosed programs and additional undisclosed assets supported by a robust portfolio of active clinical and Phase IV studies.

Within our iDose platform, we're advancing a Phase IIb/III clinical program for iDose TREX, our next-generation iDose therapy and a Phase IIIb clinical program for iDose TRIO. We're targeting FDA approval for iDose TRIO by the end of 2027. We also continue to advance various additional Phase IV studies.

Within our iLink platform, in addition to our KC screening device, we are preparing to commence a Phase III clinical program for our third-generation customized tomography-guided cross-linking therapy in 2027.

Within our iStent surgical glaucoma platform, we have completed patient enrollment of both the PMA pivotal trial for iStent infinite in patients with mild-to-moderate glaucoma and the 510(k) pivotal study for the PRESERFLO MicroShunt, and are now advancing patient follow-up in both of these studies.

Within our iLution platform, we completed patient enrollment in a Phase II study for Demodex blepharitis and expect to have top line results by the end of this year.

And finally, within our retinal platform, we recently announced an exclusive licensing agreement with RevOpsis Therapeutics for RO-104, which was assigned Glaukos development code GLK-901, a first-in-class tri-specific biologic as well as exclusive rights to the proprietary RevMod platform to discover and to develop up to 4 additional next-generation multi-specific biologics for retinal diseases. This agreement represents an important strategic step in the continued expansion of our retinal franchise and is highly complementary to our ongoing retinal R&D initiatives, including the ongoing first-in-human wet AMD clinical development program for GLK-401, our intravitreal multi-kinase inhibitor program.

We believe each of these novel differentiated platforms have the potential to generate transformative therapies that significantly improve the existing treatment paradigms for patients suffering from chronic eye diseases.

In conclusion, at Glaukos, we are in the business of pioneering new marketplaces within ophthalmology. Our record third quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified ophthalmic leader with multiple transformational growth drivers in iDose TR and Epioxa as we advance our mission to transform vision therapies for the benefit of patients worldwide.

So with that, I will open the call to questions. Operator?

[Operator Instructions] Your first question comes from Tom Stephan with Stifel.

Congrats on the really nice print here. Just on 2027 revenue, really appreciate the early look. But Joe, maybe for you, if possible, would love any initial color on how Epioxa and iDose layer into the $1 billion, notably with potential iDose LCDs looming and then obviously, with Epioxa very early days. And then as a tack-on, can you talk a bit about the decision to guide now? What went into that decision? And what gives you the confidence today to guide notably, given, again, the Epioxa ramp is early days?

Thanks, Tom. This is Joe. So as I think you heard Tom say in the prepared remarks, as it relates to getting granular around the different franchise puts and takes like we often do, we'll hold off on doing that to a future call and moment as we enter next year.

But I will say it's kind of tied into your second question as well, the confidence we had was that we evaluated all the scenarios that we're aware of thinking about next year. And as we looked at all those, including, quite frankly, downside scenarios with any iDose LCD that we saw the path lead to $1 billion of revenue. And so as we evaluated that, we felt confident that we could actually put that number out there for you all to digest.

And part of the thinking around it is indeed probably related to a certain extent about Epioxa. And looking at the historical track record, even with our iDose launch, where the investment community took obviously some of the enthusiasm around the launch and got out a little ahead of what the realities on the ground are in terms of building a new product.

And so we thought it was prudent to provide an early look as to how we thought about 2027 unfolding so that everybody has something out there to measure against as you build your models around Epioxa and hopefully continued expansion of that in our other franchise alongside it.

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

I'll echo the congrats on a nice quarter. A multipart question for me on the Epioxa launch. Would just love to get more color on the launch itself and hopefully some metrics, things like number of accounts that did an Epioxa case in 3Q. Would love to understand prior auth approval dynamics, how quickly those are going, payer approval rates. And can you just remind us if the market awareness initiatives have started yet?

Okay. Adam, I'm going to do my best. I think that was actually more like a 6-part question, and I'll work through it. But I guess the heart of it really is an update of kind of where we stand today on the Epioxa launch and as we move forward here. Obviously, we continue to be encouraged by the momentum, the $53 million that it contributed in the third quarter, really our first quarter, as you know, with the J-code having been formally established.

But probably more encouraging for us is the progress that we have on the core underlying fundamentals. And you hit on several of the most important ones. And Tom did as well in the prepared remarks, but I'll cover it again. Fundamentally, the site-of-care network is where it starts. And as you heard, we now have systems deployed as of in the third quarter that serve about 90% of the U.S. population.

If you translate that, we exited the third quarter with more than 200 established sites of care. And I'll also add that we currently have executed contracts for additional deployments that are going to extend that network to greater than 300 sites, and it's growing. In fact, the outperformance there has, quite frankly, put pressure on our operations and our field support teams where we're continuing to scale up rapidly to meet that demand that is above what we were forecasting at this stage of the launch.

The second thing you referenced was around the payer dynamics. And as we've talked about for a while, establishing payer access is first and foremost and then ultimately, over time, you'll shift into optimizing it. And you heard that we're now thankful to have open pathways for 90% of commercial lives and 80% of Medicaid lives, the latter, which is something we've never achieved with Photrexa in the past. And I think it really does speak to the clinical value of Epioxa and the overall importance of treating KC.

So our teams are increasingly focused, of course, still on the smaller regional plans and establishing access pathways, but their intention is really turning towards optimizing that access, optimizing the pathways, the adjudication time lines that you referenced alongside other initiatives. Whenever you're in the early days of a launch like this, the time lines are varied payer by payer. The processes associated with them are varied payer by payer. The mechanics and the things that you have to go through are far from a straight line.

And so our goal all along at this stage of the launch was to start driving increased efficiencies across that, whether that be within our own hub, our specialty pharmacy network or the payers themselves and how we get access to that. But I have to say that, obviously, with the results that you're seeing out of the third quarter, we're pretty pleased with the progress that we made out of the gate in that first quarter, post the J-code.

So we're seeing these get approved. We're seeing it across a variety of plans throughout the United States in line with those overall statistics. And so as we turn the page into the fourth quarter and certainly into 2027, these things start to enable the last part of your question, which is our ability to start to invest in a more meaningful way towards one of the pillars of this launch, which is changing the disease awareness paradigm for these patients, Stephen Curry being an important component of that, but there's a lot more as well behind that. And I think you'll see a significant investment from us as we make our way into and through 2027 on that front.

Your next question from the line of Larry Biegelsen with Wells Fargo.

I'll echo my congratulations on obviously a really impressive result here. Joe, just given the momentum in Epioxa, I'm wondering if you think you can get back to the 18,000 to 20,000 eyes by as early as 2028. And the 50,000 to 100,000, potentially, eyes per year, you've talked about, what's the epidemiology data underpinning that?

Yes. Thanks, Larry. Obviously, it's a hard and long leap for us to go from what are encouraging early results in the third quarter here to the precision around timing of when we'll get back to treating the 18,000-plus eyes that we saw with Photrexa or even as you pointed out, that broader 50,000 to 100,000 patient or eye opportunity that I think sits out there as we find out whether this is a true rare disease or just a rarely diagnosed one as many of our customers certainly believe.

I'll stop short of giving a time line prediction on it. I think we've always said, based upon the history here with Photrexa, the clinical dynamics around Epioxa, we'll get there and it will ultimately grow the market beyond [Technical Difficulty] in different ways, but they range from fully progressive or serious keratoconus to more mild disease that informs that broader 50 to 1,000 (sic) [ 50,000 to 100,000 ] patient estimate.

Your next question from the line of Ryan Zimmerman with U.S. Bancorp BTIG.

When Photrexa was out there, I think it was Avedro's nature to kind of go broad and maybe a little shallow, if you want to characterize it, in terms of user adoption and the number of systems out there. When I read your comments about O2N being within, say, 90% of the patient population that you want to target, I guess what I want to understand from you, Joe, is kind of how you think about that next leg of growth, maybe going a layer deeper on the user base, if you will. It seems like you're more focused on really the higher volume cornea surgeons and corneal specialists. And I'm just curious kind of at what point you take that to that next level that was similar to what we saw with Photrexa.

Yes. Thanks, Ryan. Well, first, I can't comment, obviously, on the Avedro launch strategy or dynamics. I wasn't a part of that. But what I can say in terms of ours and hopefully is consistent with what we've said before, we try to be very methodical and targeted in terms of where we went and when to our existing and other potential customers. And we really did it with a focus on both their skills and capabilities, as you referenced, their volumes, but also the geographic reach attached to make sure you've got centers.

But at the stage of a launch, especially for a rare disease category like Epioxa and keratoconus, you don't want to go too broad because it's critical that you're able to establish the right support for each of these customers as they get going and they go through the processes, especially the complicated and often nuanced and challenging processes associated with getting access to care for these patients. You really want to be prepared to support and handle your customers and those patients through that.

So we try to be very disciplined around where we went from a site-of-care perspective. And even with that, given, as I said earlier, the overall demand and enthusiasm around the product and the category, we've seen it move more quickly than what we had necessarily intended as we entered into 2026. So from that standpoint, we're there.

Now having said that, if you look at other categories, over time, you certainly will move treatment centers from that initial concentration into more and more geographies that get closer and closer to patient populations as we move forward. And I certainly expect that will be the case for us here. While at the same time, it's important when you're looking at treatment centers, we also have detection centers that we've been establishing, and we're north of 700 of those already throughout the United States. So that's a great place for these patients as they initially might think that they have keratoconus to go and get screened and ultimately, to the extent that they have a diagnosis or a positive risk factor, that they're then triaged over to our site-of-care network that's out there today.

Got it. And I feel like Alex is often ignored on these calls. We spend too much time talking on Epioxa and iDose. But the gross margins obviously stand out. There was some one-timers in there in terms of recognized adjustments. But I mean, that aside, Alex, what do you think about margin durability here at these levels and what you can do as we think about '27 and so forth?

Ryan, first of all, I love you. Thank you so much for recognizing me. That's great. Thanks for the question. As it pertains to gross margins, you're right. I mean, certainly, we've been saying it for a while throughout the year, we expected to see expansion in the gross margin as iDose -- both iDose and Epioxa, quite frankly, became a larger share of the mix of our revenues. And so we've seen that come to fruition, the third quarter being really, really strong at almost 88%.

As far as durability, we wouldn't expect it to not be durable, given the fact that Epioxa and iDose continue to be the 2 most transformative revenue growth drivers. And our expectations are those will continue to be a larger share of our mix as we go through the rest of this year and next year.

Your next question from the line of Allen Gong with JPMorgan.

Kind of piggybacking on the cost discussion, I think you're talking about a lot of commercial activities to make sure that you're getting Epioxa the kind of support that it needs to succeed. And clearly, we're seeing that work in third quarter. Despite that, it seems like you didn't really have to spend too much on SG&A. It sounds like you have some other projects maybe in the works for the balance of the year, maybe into 2027. So how should we think about SG&A for fourth quarter and also just in 2027 and going forward, how should we think about growing that on a dollar basis?

Yes, Allen, it's Joe. I'm going to start off and let Alex comment beyond that. To clarify, in the context of the third quarter and kind of where we're at in the commercial investment cycle, clearly, we've been making a series of investments throughout our organization, sales force, marketing, market access and related for some time.

I'm not sure that, that particularly changed in a meaningful way in the context of the third quarter. And what I was referencing really is -- and the success that we had in the third quarter was really in advance of a material pickup in the kind of both disease awareness and brand awareness initiatives that we had planned for 2027, both for keratoconus as well as interventional glaucoma, Epioxa and iDose. So the results you're seeing are a little bit ahead of those activities and those investments that we plan to make going into next year.

Yes. And then, Allen, I'll just add on there. For the rest of this year, and I think you were alluding to that, you can expect our operating expenses to continue to grow in the fourth quarter. I would guide you to say that growth rate should be 25% to 30%. So we would continue to maintain operating leverage in the model. And then that would land your full year 2026 operating expenses somewhere around plus or minus $630 million. That translates to just over 30% year-over-year growth. So again, still showing that operating margin. And then we'll get to 2027 in a later call and give you more granularity about operating expenses at that time.

And then just when we kind of think about Glaukos, the pipeline, the commitment to internal R&D is definitely one of the major things that stands out, but you're going to be building up potentially a lot of cash with the launches of Epioxa and iDose. And while there's a lot to reinvest into organically, I'm kind of curious, from an inorganic perspective, what makes an opportunity something that you'd want to develop in-house? What's an opportunity that you would maybe be looking at externally to invest into?

Yes, Allen, this is Tom. I'm happy to take that question. So when you think about it, we've got 14 disclosed development programs underway as we speak. Those have to be fed and nurtured to commercial fruition over the next years towards the end of the decade. But most importantly, some of the new initiatives that we've taken on will both be extraordinarily important for [ incendiary ] growth longer term, but will take some pretty significant capital to bring to market.

So let's take our 2 major initiatives that we've taken on in retina. One, as I've said all along, we have the temerity to believe we're going to become a retinal company. And indeed, we're making progress towards that. So first, we have the tyrosine kinase inhibitor, axitinib, which is now really going through its Phase II clinical apparatus. We'll have data by the end of the year to see where we are there. We have a second-generation TKI under development. And then you see the work that we've taken on with RevOpsis, looking at this tri-specific anti-VEGF compound, which is really a first-in-class to be able to enter that marketplace.

Each one of these projects really, just from a clinical perspective alone, exceeds $100 million in investment. So, these are extraordinarily expensive, but extraordinarily important products as we look for catalysts for growth beyond both the work that we're doing within iDose TR, our work in rare disease and our work in Part D pharmaceuticals, which we haven't even begun to fully talk about led by the Demodex blepharitis compound, which is physostigmine, an acetylcholinesterase inhibitor, which we will have data by the end of this year.

So it's an extraordinary pipeline. I guess I'd put it up against any company in ophthalmology. It will take resources to get there, and we're going to be able to command the resources to be able to internally grow our way into, I believe, a massive comprehensive strategic leader.

And Allen, obviously, you've known us for a while. It shouldn't come as a surprise that us now generating cash flow isn't going to change the operating strategy or DNA that's gotten us here. And that's what you're hearing from Tom that we're an organic development company first. And even where we do deals outside, they fill into that pipeline nicely, and I expect that to be our strategy as we move forward.

Your next question from the line of Richard Newitter with Truist Securities.

Rich, you may be on mute. We can't hear you. Can we go to the next question, please?

Your next question from the line of Mason Carrico with Stephens.

I was wondering if you could give us some insight into the percentage of Epioxa volumes that came via the buy-and-bill channel in the quarter. I guess how has the build-out of that channel tracked your internal expectations? And really, how do you think about the growth of that channel to accelerate adoption of Epioxa, moving forward?

Yes. Thank you. So I will tell you, as we went into this launch, we expected the buy-and-bill-related dynamics to certainly lag that of our specialty pharmacy channel, if you will. But I will say, our network of sites that are buying and billing Epioxa has been increasing rapidly and particularly over the last 30 to 60 days. And it's really been a combination of customer types, strategic accounts that have affiliated clinics as well as individually owned physician offices alongside the hospitals and larger institutions that you'd expect.

So it remains still relatively early in those days, but an important contributor as we exited the third quarter and going into the fourth and as we go forward here, we've been very encouraged by the receptivity and ultimately, the execution of our customers to make sure that they're providing access for those patients who have to receive the drug via the buy-and-bill pathway.

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

I guess maybe switching to iDose. Can you talk to us about the trends you were seeing in 3Q and maybe what your expectations are now for the full year this year? And I guess part B of that would just be, to the extent we do get an LCD update before the end of this quarter and it is restrictive, do you expect there will be some kind of accelerated buy ahead or pull forward from docs who want to get some of the volumes in before the LCD takes effect?

Sure, Michael. So obviously, in the third quarter, we saw $76 million of revenues, and that was driven in particular by growing contributions from the fee-for-service population in the NGS jurisdiction alongside growing contributions from Medicare Advantage and commercially insured patient populations, which is aligned with what you've been hearing from us in terms of strategic imperatives as we entered this year.

And those dynamics, the growth dynamics were soft and, I'll call it, touched by summer seasonality, but we were encouraged to still grow despite that. And so we feel like we continue to be on an encouraging trend there. As you think about the remainder of this year and you do your models, inside of our guidance implies an increase from prior expectations, which we had communicated were $275 million to $280 million, to now, iDose, we expect to reach into the low 280s, which represents a more than doubling of our 2025 performance as we continue to move forward here with this launch.

As it relates to any potential LCD, to the extent that, that came out, there's restrictions, it's possible to some customers. But it's also important to remember that the fourth quarter is a pretty busy one for many of our customers. Their surgery schedules are full. And so their ability, necessarily, to make a hard pivot in advance of any LCD coming into play would be challenged by that fact.

Your next question from the line of Joanne Wuensch with Citi.

It sounds like there may be an LCD, there may not be an LCD. Is that the right way to hear it? And if so, is there a go/no-go time frame like if by X date, we don't get something, we don't have something? I mean help me understand when I have to stop thinking about this.

Well, I think in the world of reimbursement, you never get to stop thinking about all the various scenarios that can emerge, whether that be from commercial payers or in this case, the government in the form of the MACs.

At this point, we don't have any new updates to share. To the heart of your question, the only statutory obligation that the MACs have is 1 year from the date of their draft, which was May, to act or abandon the LCD. Obviously, if they do propose a final LCD, then it has a 45-day waiting period or cooling-off period before it gets enacted.

And at this point, we continue to believe the MACs are digesting the significant evidence that the physicians and societies and patient groups and Glaukos presented during the comment period. And we continue to think it validates the clinical value that has been objectively proven in a pretty wide patient population. So we watch and wait like you all do, and we'll monitor it accordingly.

Your next question from the line of Richard Newitter with Truist Securities.

Can you hear me?

Yes, we can.

Okay. Congrats on the quarter. Sorry, I'm not sure what happened before. Just 2 very quick ones for me. The first, just as we think about Epioxa ASP, can you just give us a sense for kind of where that shook out or where we should be modeling that for the back half of '26 and maybe even for '27?

And then the second question, just piggybacking off Joanne on the LCD here, how does a study like you just talked about on the call and a few weeks ago press released, how does a study like that factor into the LCD decision process? Like, is that something that you can just pile on and the evidence accumulates and they'll consider that? Or does it need to be socialized for a longer period of time or in a peer-reviewed publication? Just trying to get a sense for how something like that might actually influence the decision to the extent that they still can before the LCD finalizes.

Yes, I'm happy to take, and then, Joe, you can add some color. I'm happy to take the question, Richard. And so the study that we had really was a prospective multicenter study, Level 1 study, that compared cataract surgery alone versus cataract surgery plus iDose. And I'm extremely pleased with the results, a 3.6 millimeter additive effect of using iDose versus cataract surgery alone and over 11 millimeters reduction in intraocular pressure.

Having said that, the study was done really for twofold reasons. One, to the extent we're ever challenged on the use of using iDose in combination with cataract surgery, we would have kind of respondent data to be able to show -- robust data to show that we indeed had an additive effect. It appears, as you've seen, that the MACs have taken the position that they are okay today with the use of iDose in combination with cataract surgery. We expect that to continue. We did this kind of as an insurance policy.

But what it also adds is the ability for us to then go to our customers and be able to validate and show what the incremental advantage of using iDose in combination with cataract surgery is. So that's very important.

I think to the heart of your question, what we're doing, too, which I'm hoping is prescient, is to have a study that compares iDose plus iStent infinite versus iDose alone. So the goal there is, to the extent that MAC, if there is an LCD that's issued, restricts the use of the combinatory use of iDose with MIGS procedures, we would have the ability to have a robust prospective Level 1 study to show that there indeed is an incremental effect of using iDose in combination with iStent infinite versus iDose alone.

To the extent there is a restriction, we then have the ability to then ask for a reconsideration request that we would submit and then be able to move forward with an appeal. Much like we've done on the readministration side with the FDA when we got readministration of iDose approved, we'd do the same thing with the MACs for reconsideration.

So I think we're about as prepared as we can be and armed, both to have robust adoption in the marketplace and to protect our flanks from any movements that the MACs may take.

I think as a technical matter, as I referenced earlier, the common submission period for this LCD consideration is over. And so they're in the process of digesting everything that's already been submitted to them and the robust body of evidence that was done as a part of that process. That doesn't mean that the society or physicians or even Glaukos might not try to make sure that they get a view of important publications like what Tom was just talking about or any other that may come out during the course of the next several quarters. But as a technical matter, they've got the body of evidence in front of them that they're digesting in the context of any potential LCD that they may or may not propose.

As it relates to Epioxa's ASP, which I think was the first part of your question, I think we've been pretty consistent in saying to assume in your models a $65,000 to $70,000 net ASP. I have no reason -- we have no reason to give you a different direction at this stage. It's still early. And in the early days, you'd expect to trend towards the higher side of that from an overall realized net ASP perspective. And we'll continue to give you, guys, feedback on that if it changes as we move forward.

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

Congratulations. Joe, you mentioned the KC screening device launch in '27. Can you talk a little bit more about how you'll deploy and leverage that? Will it go into optometrist office, into screening centers, I think you mentioned? Just overall, it seems like this has the opportunity to further accelerate the referral pathway into the centers. And I'm curious how you're building that network and how the screening device fits in.

Yes. Well, look, as we think about that next stage of the Epioxa and overall keratoconus launch, as you move past those sort of foundational investments and layers that I spoke to earlier, you really get into the 3 core areas that we're trying to execute on to transform the patient journey, if you will, and the ecosystem around these KC patients.

The first of which is we need to double and triple down on investing and really elevating awareness. You heard us talk and Tom talk about in the prepared remarks, the investment we made in Stephen Curry, and that's really just the beginning. As we think about the detection centers and the KC screening device, the job there is to democratize screening, right? The idea that you can bring a simple, straightforward device to hopefully the masses across optometry.

Unlike what we're talking about here in our treatment centers, where we're measuring those in 200 to 300s, there are 50,000 optometrists in the United States or more. And so we want to make sure that we're deploying technologies that can be utilized by as many of those as possible to at least screen for keratoconus, and when they do get a positive screen, that they're able to refer those to centers and get those patients definitively diagnosed and hopefully treated as quickly as possible.

And the last thing really is then, once they have been, are we optimizing our support of that patient journey. And that comes into everything we're trying to do from the patient perspective of supporting them and our hub and our specialty pharmacy and the things in and around those activities.

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

Obviously, congrats on the quarter. So my question is just around 2027 and the LCDs. Joe, I think in the past, you've talked about iDose revenue being flat in '27 if the LCDs are, in fact, finalized. So relative to the kind of low 280s you talked about earlier in the call for '26, is that still how you're thinking about the impact if those LCDs are, in fact, finalized? And then relative to the $1 billion guide for '27, like what's assumed in that in terms of how the LCDs play out?

Yes. Thanks, David. I'm going to go in reverse to the way that you asked that. First, as it relates to the $1 billion preliminary expectations for 2027, we've really factored in all the scenarios, including scenarios where the LCD is proposed or finalized close to as proposed today and then the impact that, that would have on iDose and our overall U.S. Glaucoma business. We remain confident that we could still achieve that $1 billion revenue number in the year. And that's a large part of what gave us the confidence to put that out there at this point in time.

As we get more specific on that, I'm not sure I've ever tried to give a point estimate around next year. I think when asked, I've said if it helps you to keep in that frame of mind to hold that sort of constant and not get ahead of yourself in terms of the roll forward of the success we're having in 2026 into trends in 2027, I thought that was a safer place to be. But we'll hold off on giving anything more specific until we actually see what transpires in the form of an LCD and when it transpires so we can analyze that properly and give a more thoughtful commentary on its impact on iDose.

Your next question from the line of Anthony Petrone with Mizuho.

Congrats on the quarter here. Two on Epioxa. I guess one is on prior authorizations, just some channel checks hearing that even though we're seeing a good pull-through from buy-and-bill, you're still having some plans that have this extended prior authorization process, but the demand is there. So what actually opens that up? What type of communication do you have with some of the commercial payers to ease up on prior auth?

And then second real quick would just be when we think about EpioxaCareConnect, is one of the ways to sort of loosen that log jam up is to push more through specialty pharmacy, which then will have some handholding through EpioxaCareConnect?

Yes. Anthony, I think maybe I'll address that all as one question, which is, at this stage of a launch, you expect, as much as it's not welcome, elongated periods of time from initial diagnosis and access to therapy to when you ultimately get those prior authorizations approved and the drug shipped, if you will. And that's an ordinary course process for all pharmaceutical launches and, in particular, any rare disease, one that's there, because the prior authorization process in some ways is designed for the payer to learn themselves.

And while some of us might feel like that's a fairly intentional activity they put that through to delay that access to care, the reality is they use that information that they're gathering through prior authorization process to inform their own internal processes. But ultimately, the way you get to a place where it operates more efficiently is through volume, right? It's through the time and the processes to where these payers start to recognize that the providers are putting through bonafide claims for patients who are worthy of treatment for Epioxa and that they're approving them. And at that point, they'll start to focus on their own efficiencies over, I'll call it, this early process of educating.

But we saw this play out with Photrexa over the course of many years, where they went from a lot of hurdles to fewer hurdles and ultimately got to a place that access was a bit more streamlined. And we would expect that same thing to play out here over time. And our job is to continue to fill the funnel with the patients seeking access to the therapy and then supporting our customers and those patients through that approval process journey, if you will. And that incorporates our hub, EpioxaCareConnect, as you referenced, that incorporates our specialty pharmacy partner, and it incorporates our customers who seek to buy and bill the pharmaceutical to get that access.

It's really all of the above, and we're hyper focused, now that we're getting through the initial days of the launch, on trying to get more and more efficient, so these patients can get access to that therapy faster.

There are no further questions at this time. I will now turn the call back to the company for closing remarks.

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

This concludes today's call. Thank you for attending. You may now disconnect.

Hello, and welcome to Glaukos Corporation's Second Quarter 2026 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. [Operator Instructions] 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 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. [Operator Instructions]

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 into Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and earnings press release available in 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.

Today, Glaukos reported record second quarter consolidated net sales of $185.6 million, up 50% on a reported basis and 49% on a constant currency basis versus the year ago quarter. As a result of our second quarter outperformance, we are raising our full year 2026 net sales guidance to $680 million to $700 million, an increase of $60 million to $65 million over our prior guidance of $620 million to $635 million.

Our second quarter results reflect strong performance across our global commercial and development priorities, underscoring the successful execution of our teams, the strength of our differentiated technology platforms and our continued evolution as an increasingly diversified leader in ophthalmology.

Looking ahead, we believe we are well positioned to sustain this momentum, driven by 2 transformational growth drivers, including the further advancement of the interventional glaucoma treatment paradigm with iDose TR and the launch of Epioxa, establishing a new standard in interventional keratoconus and rare diseases.

Together, these compelling and durable market opportunities reinforce our confidence in our ability to deliver a best-in-class growth and margin profile well into the next decade. At the same time, we continue to invest strategically across our industry-leading pipeline and commercial infrastructure while maintaining a focus on disciplined capital allocation to support sustained operating leverage and cash flow. While our priority remains to maximize near- and long-term growth, we were pleased with our progress across our P&L in the second quarter.

Now let's discuss our second quarter resultsSpe in more detail. Within our U.S. glaucoma franchise, we delivered record second quarter net sales of $118.5 million on strong year-over-year growth of 64%, driven by growing contributions from iDose TR, which generated sales of approximately $74 million in the second quarter.

iDose TR continues to deliver strong clinical outcomes that meaningfully improve patients' lives, resulting in strong physician interest and adoption while helping to accelerate a broader treatment paradigm shift towards earlier interventional glaucoma care.

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 robust and growing body of clinical evidence, which now includes 24 peer-reviewed publications, complemented by a broad portfolio of active Phase IV studies across diverse real-world clinical settings, further enforcing and reinforcing its consistent performance in real-world practice.

Earlier this month, CMS issued its proposed rules for 2027, which as drafted, largely maintain the 2026 APC assignments, associated facility payments and relative physician fee rates associated with our procedures across both the hospital outpatient and ASC settings.

Additionally, as many of you know, during the quarter, 5 of the 7 Medicare administrative contractors issued proposed local coverage determinations for iDose TR. We were encouraged by the overwhelming support from physicians, medical societies and other stakeholders throughout the open meetings and public comment period, validating the meaningful clinical value that iDose TR is delivering to patients.

We continue to believe that the strength of iDose TR's clinical evidence, real-world outcomes and broad stakeholder advocacy support appropriate Medicare coverage that preserves physician decision-making and patient access.

Moving on. Our international glaucoma franchise delivered record net sales of $36.6 million on year-over-year growth of 17% 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 MIGS forward as the standard of care in each region and major market in the world.

As previously discussed, we continue to expect new competitive product trialing headwinds in some of our major international markets as we progress through 2026, partially offset by growing contributions from iStent infinite following its EU MDR certification and associated European commercial launches 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 $30.4 million on year-over-year growth of 48%, including Epioxa net sales of approximately $11 million.

Turning to Epioxa. We remain very encouraged by the early progress of our commercial launch as the first and only FDA-approved epithelium-on corneal cross-linking therapy for keratoconus, Epioxa has been met with strong interest from surgeons and the broader ophthalmic community, reinforcing our confidence in its potential to redefine the treatment paradigm for this rare, sight-threatening disease that is currently far too often undiagnosed and untreated.

Our launch priorities remain centered on expanding patient access, building awareness, optimizing referral networks and driving earlier diagnosis. We continue to make meaningful progress across each of these areas, including the ongoing expansion of our site of care network, establishing broad market access and the implementation of our specialty pharma infrastructure and robust patient support programs.

First, I'm proud to report that we've successfully established and continue to selectively expand our broad-reaching site of care network. Our acquired O2N systems are already actively deployed across locations serving roughly 85% 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%.

Next, we continue to make considerable progress with payers to secure access pathways or policy coverage for Epioxa, with access pathways now established for more than 125 million covered commercial lives in the United States, including with the 5 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.

As anticipated, Epioxa's new product-specific J-code, J2789 became effective on July 1, 2026. While we expect it will take some time for this to be solidified operationally by providers and our specialty pharma partner, we believe this now effective code will help streamline the reporting and reimbursement processes for Epioxa among US payers over time.

Beyond market access, we're proud to lead the way once again of forging a new path for interventional keratoconus 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've launched a co-pay assistance program for eligible patients. While we remain in the early stages of the launch, we're encouraged by the solid progress we're making against our core launch priorities and remain very excited by the significant potential Epioxa offers to patients living with keratoconus.

Beyond Epioxa, we continue to advance a broad and differentiated clinical pipeline across our 5 novel therapeutic platforms, encompassing 13 publicly disclosed programs and additional undisclosed assets supported by a robust portfolio of active clinical and Phase IV studies.

Within our iDose platform, we are advancing a Phase IIb/III clinical program for iDose TREX, our next-generation iDose therapy and patient follow-up in a Phase IIIb study for iDose TRIO with a targeted FDA approval by the end of 2027. We also continue to advance various additional Phase IV studies.

Within our iLink platform, we remain on track for our planned commercial introduction of our KC screening device later this year and are preparing to commence a Phase III clinical program for our third-generation customized topographically guided iLink therapy in 2027.

Within our iStent surgical glaucoma platform, we are advancing a PMA pivotal trial for iStent infinite in mild to moderate glaucoma patients and recently completed patient enrollment in our 510(k) pivotal study for the PRESERFLO MicroShunt. Within our iLution platform, we recently completed patient enrollment in a Phase II study for Demodex blepharitis and expect to have top line results in hand by the end of this year.

Finally, within our retinal platform, we are advancing a first-in-human clinical development program for GLK-401, our intravitreal multi-kinase inhibitor retinal program in wet AMD patients.

We believe that each of these novel differentiated platforms have the potential to generate transformative therapies that significantly improve the existing treatment paradigms for patients suffering from chronic eye diseases.

So in conclusion, at Glaukos, we're in the business of pioneering new marketplaces within ophthalmology. Our record second quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified ophthalmic leader with multiple transformational growth drivers in iDose TR and Epioxa as we advance our mission to transform vision therapies for the benefits of patients worldwide.

So with that, I'll open the call open for questions. Operator?

[Operator Instructions] Your first question comes from the line of Tom Stephan with Stifel.

Congrats on the nice quarter here. Maybe on Corneal Health, nice start to the Epioxa launch. Joe, maybe for you. Can you talk about, I guess, where your expectations now stand on 2026 Corneal Health revenue growth? I think previously, it was high single digits. And then if you can help us understand the puts and takes as we think about the Q3 and Q4 cadence. I know the earnings summary, I think, mentioned some transient headwinds in 3Q amidst the transition to Epioxa, but any more color on the cadence would be great. Congrats again.

Yes. Thanks, Tom. Happy to jump in there. Obviously, we were very encouraged by the contribution of Epioxa in its first full quarter really of commercial availability, particularly when you consider the unavoidable challenges that go along with the miscellaneous J-code period that's there.

And as you heard Tom mention, obviously, our primary focus today remains on those building blocks that we think really set up Epioxa for long-term success. And I can certainly talk more about that as we make our way through the call here. But as I think about the translation of how this plays out for the remainder of this year, and again, orienting you back to where our focus is at is making sure that we get the right puzzle pieces in place to drive optimization in 2027 and beyond.

We know that the third quarter will come with some transition as it relates to the permanent J-code. We've talked about that for some time. So you end of the third quarter having sunset largely Photrexa, while launching, if you will, Epioxa in the permanent J-code setting.

And so there will be some volatility around that. It makes it much more difficult than usual for us to forecast during that stretch. And so there's a wider variety of scenarios, I guess, the way I would say it, around the potential outcomes of Epioxa as we transition that way throughout the third quarter and certainly into the fourth.

I think as we get into the fourth quarter, we have a lot more conviction that some of those J-code translation or transition-related issues should start to get behind us, and we should start to see that uptick as we think our way -- making our way through the fourth quarter and into the beginning of next year.

So I think we're going to have some transition here, while we make our way through. And we may ultimately deliver terrific results. But I think we want to make sure that we're staying somewhat conservative here as we navigate really what is a unique transition for us.

And then for the full year as it relates to Epioxa or really our overall corneal health franchise, we started off this year saying we were confident we would still grow. And then we ultimately, I think, upgraded that to high single digits. And now I think we're confident in saying that for the overall year, Corneal Health should now be able to grow, call it, 20% plus or minus on a year-over-year basis, Just again, based on that strong Q2 performance and then the growing Epioxa contributions as we make our way through the remainder of the year.

Your next question from the line of Adam Maeder of Piper Sandler.

Good afternoon, and thank you for taking the questions. Great quarter. I guess just one for me. I'm going to be pulling on the modeling thread question. You just talked about expectations for the Corneal Health business. But Joe, in the past, you've given a lot of really helpful color across the different segments. So just wanted to see if you could kind of provide updated thoughts on how you're thinking about iDose contribution versus the stent business versus OUS in corneal health for the second half?

Yes, I'm happy to do that. As both you and Tom alluded, we obviously very pleased with the strong second quarter. And really, each of our franchises exceeded expectations. And so as a result, we're happy to be able to raise guidance in line with what you heard Tom mentioned earlier to the $680 million to $700 million mark.

If you think about your kind of models by franchise, and I think it requires adjustments across all the franchises given that outperformance. First, on international glaucoma, I would say we've increased our expectations there now where we expect to achieve low to mid-teens year-over-year growth for the overall year.

As you think about the second half dynamics within that, you do have the FX tailwinds abating. We've called that out before, and we certainly expect that, and we're kind of past the, I'll call it, the FX benefit now on a year-over-year basis. So that will be a relative headwind as we make our way into the second half. And we'll continue to navigate competitive dynamics in those international markets and some reimbursement headwinds that have emerged in Germany and Switzerland, but offset that by continued growth of PreserFlo and Infinite and really our overall interventional glaucoma market developments abroad.

So I think we're pleased to be able to increase our expectations there to low to mid-teens for the overall year. You heard me reference the Corneal Health side of things before, so I won't spend as much time there. But just again, reiterating that the 20% growth year-over-year, plus or minus, items to factor in, especially in the third quarter, the impact from sunsetting Photrexa shifting to the permanent J-code for Epioxa. It's possible we'll have a bit of an air pocket there as we make our way through this quarter. But we remain confident that, that air pocket will be behind us by the time we get into the fourth and moving out of the full year.

And then finally, on the U.S. glaucoma side, we now expect full year growth of right around 50%, plus or minus for that business. And that's really driven by 2 things. Obviously, I think we now can say that we would expect for the year at least low single-digit growth of our broader portfolio and then the continued expansion of iDose TR, which I think when you do all the math, you're going to land somewhere in that, I'll call it, $275 million to $280 million range for iDose in 2026.

Your next question from the line of Larry Biegelsen of Wells Fargo.

Pretty impressive quarter here, guys. So I'll do the first ask about the iDose LCD. So since the open meetings for the iDose LCD, has your -- how is your confidence in the revised policy changed? Which provisions do you think are most likely to be changed in a potential final LCD? And if the proposed LCD stayed the same, how would that impact your thinking around iDose over the next few years?

Yes. Thanks, Larry. I mean, to your point, clearly, a lot has transpired on this front between the draft LCD that came out in May, the open meetings in June and the formal submissions in early July. And really, I think the way we always had conviction, as you can imagine, around the evidence associated with iDose in a multitude of settings and use cases and certainly, perhaps most importantly, the study that supported the approval of iDose and all the evidence that generated a wide open label in that regard.

So we were encouraged, as I think many of you were by the overwhelming support from physicians and the medical societies and even patients throughout the country. The objective and high-quality evidence that was presented really just validated our belief in the clinical value of iDose.

So -- at this point, we certainly believe that the MACs are digesting all that evidence that was presented and submitted. And while there's no statutory next step or even timing in that regard, we do believe that ultimately, it should come out in a more favorable position to the extent that it is proposed as a final LCD.

As I think about in the context of moving forward, what may or may not shift, I think it would be a recap of what you heard during those meetings. I think there was a pretty strong opposition to the underlying criteria associated with each of the provisions. There certainly was a lot of opposition to the idea of having multiple components to the -- I'll call it the step edit associated with both drops and SLT. -- you heard significant pushback around glaucoma as a disease and the right way of treating it and thinking about it clinically and really not reducing the optionality for physicians to utilize multiple tools that are complementary in the case of iDose and other MIGS. And so I think all of those things had compelling evidence presented and certainly are in play as it relates to the overall.

As I think about the final part of your question, which is how does this impact the years to come if it were finalized as it is, while I think it's highly unlikely that, that would be the outcome of any process here. I think it's important to remind folks some things that we talked about when investors were on the road. I think the continued strength of the business that you see in iDose today, I think shortens the put, if you will, in the context of the bridge to the expectations that existed previously around 2027 and beyond.

And maybe more importantly, even in an SLT world, I just remind investors that there are 500,000 to 600,000 SLTs done a year, and that's been being done for quite some time, meaning that there's a pretty large market there of patients, both in terms of annual incidents as well as the overall prevalence pool for iDose to continue to make a meaningful contribution.

Now clearly, if something came forward that was not aligned with what we believe is appropriate clinically, not only would we object strenuously that alongside the society, but we would also continue to provide the evidence that we have already generated or will generate to make sure that for the long term of iDose and interventional glaucoma that we rectify any wrongs that are part of the final proposed LCD.

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

Let me echo my congrats. It's really impressive. Maybe turning back to Epioxa for a minute, Joe. You talked about some of the patient co-pay dynamics that you're standing up. And I'm wondering if you could elaborate on kind of how you think about the gross to net pricing for Epioxa over time? And the second component of my question, I'll sneak in a 2-parter into one question just to keep to Chris' rules. But when you think about the O2 placements and the 85% of the user base, what are you seeing? Are you seeing new users take over these systems? Are you seeing upticks in a select cohort of corneal surgeons in terms of higher utilization early on some of the early adopters? Just if you could kind of reflect on kind of that user base dynamic as well.

Of course. I'll pretend like it was one question, Ryan, so that I don't get trouble with Chris. First, as it relates to the Epioxa kind of gross to net dynamics, obviously, that's something that we'll be watching and Alex will be watching alongside of us here as we get a bit more maturity in the market launch of Epioxa. But what I think generally, we've said to investors is I think a safe place out of the gate is to think about it in that kind of net $60,000 range. And that's really meant primarily to include the impact of Medicaid pricing and the various other required discounts as a part of the launch. We're not necessarily doing much beyond that at this stage of the launch. So it comes down to that mix that happens with Medicaid, and places like the Department of Defense and things like that. So as we make our way through, we'll hone that in a bit more from there. But I think $60,000 is a good place.

On the O2N system side, we made a lot more progress during the quarter, and we were already well ahead of our expectations. I think at this stage, if you'll say you've got systems deployed at sort of 85% of the U.S. population and that pipeline progressing towards 95% of the country. When you actually think about the country from a geographic perspective, that's about as good as it gets in terms of the way you think about an installed base, certainly at this stage of the launch.

And as the J-code came online, we've seen even some of those folks who were a little bit slower in their process and approvals, picking up the pace of getting that in line going forward. I would say it's not so much about any particular cohort of patients or sites. You've got private sites. We've got parts of large groups that have sites in their network. We've got hospitals and 340B institutions that are there.

There certainly are some new, but I would say it's been much more about taking a look at our prior base of customers and leaning into those folks that historically have both geographically and from a patient focus standpoint, provided the optimum care in terms of their treatment times, their commitment to it, the education with the optometrists and the community and all the things you want to see to make sure that you're optimizing your network, especially in these early days where you can't afford to have a massive number of centers.

So we've really leaned into what I would call the Tier 1 and Tier 2 sites and our conversion of those have been extremely high. And so we're pleased with what that looks like. And in terms of the early utilization, I think it's really been pretty profound in terms of the number of patients that almost all of these sites have started to put into our hub and seeking to get approval for Epioxa given the clear benefits of that therapy over the legacy of an epi-off solution like Photrexa.

Your next question from the line of Allen Gong with JPMorgan.

I guess starting off on like a different tack. I think not only did the top line do quite well, it looks as though your performance down the P&L was also quite strong once we back out the onetime SBC charge that you look to have recognized in SG&A. So I know that in the past, the messaging really has been a focus on reinvestment back in the pipeline. We saw that with R&D stepping up another $8 million sequentially. But how should we think about the potential for profitability in the back half of the year? Is that something that you're willing to let fall through? Or are you just going to ramp up investment even more to reflect your success?

Allen, it's Alex. I'll take that question. And you're right, we were pleased with the progress that we saw in the second quarter across the entire P&L from the margin to operating expenses to the bottom line as well. including cash generation in the quarter that we saw.

And again, like we've said to investors in the past, given our company's gross margin profile, there's certainly a clear line of sight that we have today towards Glaukos seeing profitability at some point in the future. And it's increasingly more and more towards the near term as we see the increased revenues from these 2 transformative drivers.

But that said, we would remind investors that our management focus continues to be on prioritizing and prudently investing back into the commercial business to support these 2 transformative launches as well as supporting the R&D pipeline and things that you saw in the quarter as we stepped up, especially in clinical as we've grown our clinical trial programs that Tom was referencing in the prepared remarks. And that is just really again driven to maximize both our near-term and long-term top line growth profile of the company.

Your next question from the line of -- Truist Securities.

Congrats on the quarter. I guess, I just want to -- I'll ask very quick ones on iDose and one on Epioxa. I guess on iDose, this is such a substantial sequential uplift. I get that the reimbursement environment is getting better. But was there any pull forward or just consideration from your customer base on everything going on in the background with the LCD? I'm just wondering if you're starting to hear or see any of that.

And then on Epioxa, I'm just curious if from a 340B standpoint, is there anything that we should be thinking about from an ASP standpoint or how that might impact pricing there?

Thanks, Richard. First, on the iDose front, there was no that I'm aware of LCD-related pull-forward dynamics in iDose. I mean, most of the surgeons you talk to, their schedules are pushed out well beyond even that time frame from when this came on. So if you're going to see that, I think it would be something that was on the heels of actually a proposed final rule if it were ever to come out.

So I don't think that was really the case. And what we really saw in the quarter was the first time where you had -- obviously, we had meaningful growth in the beginning. But in this quarter, we really saw both an acceleration across the various MACs. I would say with the most recent additions of the professional fees in NGS and Palmetto, you saw that contribution pick up.

And then maybe even more importantly or equally as important, we saw a nice uptick in activity around the commercial and Medicare Advantage patient populations as well as more of our customers started to expand utilization of iDose into those patient populations.

So I would say it was a diversified performance in the quarter. The strength of it does give us a little bit of pause, I'll call it, in terms of conservatism around how we think about that into the third quarter and through the remainder of the year. We're still early in that launch as well. And so when you have quarters of this magnitude, you want to make sure you still stay somewhat cautious about how that will translate certainly into a, I'll call it a seasonal down quarter in terms of ophthalmology procedures in the third here.

As it relates to Epioxa and 340B pricing, that's really factored in as a part of the prior question that I think Ryan asked. So -- when we think about the gross to net and what that kind of realized average ASP, and we've sort of consistently said around $60,000 is our starting point, that really factors in the impact of the 340B institution-related volume and the discounts associated with selling product into those institutions.

Your next question from the line of Joanne Wuensch with Citi.

I want to sort of zero in on some of the expense management that we're looking at. In particular, gross margins have reached a new high by my math. Last quarter, you gave us 84% to 86% gross margins for the year. I don't know if that's still consistent. And similarly, it looks like you are starting to leverage OpEx, what your current thoughts are for that.

Joanne, it's Alex. Thanks for the question. And yes, we were pleased absolutely to see the continued accretion in the gross margin during the quarter. And as you mentioned, it landed approximately 85%, which was up roughly, call it, 90 basis points from last quarter. And that accretion was driven, as you might expect, from the growing contributions of iDose and Epioxa and the overall revenue mix.

And you were asking about looking ahead, we would continue to expect modest gross margin accretion over the remainder of the year and particularly in the fourth quarter as the iDose and Epioxa sales continue to become a greater share of our revenue mix. Now that all said, we'll continue to stick with our targeted guidance range for the year of a gross margin of 84% to 86%. We're holding that steady as we move forward at this point.

And on op margins? For OpEx, which is usually yes.

On operating expenses -- yes. No, that's exactly right. We -- obviously, we're encouraged to see the operating leverage in the quarter. And our philosophy remains the same. We're going to continue to push our operating expenses such that we realize the leverage in the model while still investing in these priorities around commercial and R&D, and that will be our philosophy going forward.

And again, you couple that with the cash and what we're trying to do there, and we're just trying to manage the business towards a cash flow breakeven stance and those all kind of pull together and triangulate.

And I guess, Joanne, I'll just end just to get it out there on the record that for operating expenses for the year now, given the outperformance on the top line, you can expect our operating expenses to land somewhere around $600 million for the year.

Your next question from the line of Mason Carrico with Stephens.

Appreciate the questions here. Going back to the guide, you called out iDose revenue in the $275 million to $285 million range this year. That seems to imply pretty minimal sequential growth from the Q2 numbers. So just to confirm, is that largely just driven by your commentary around being conservative on commercial and Medicare Advantage volumes? Is there anything else in the back half we should be aware of?

Yes, Mason, there's nothing I would call out in particular around it. I think I sort of answered that before by saying that whenever you have this level of outperformance in a quarter, and it's really the first -- we certainly continue to see sequential growth and progress throughout our launch and strong growth on a year-over-year basis.

But the second quarter was so strong. I think we'd like to see another quarter or 2 of that before we call it a trend. And so I think we just want to be cautious about how you translate that Q2 number into Q3 in particular. And just knowing that volumes seasonally tend to be down in the third quarter. And given that outperformance in the second, I just would be a little bit conservative around the third quarter iDose number and give us a little bit of time to determine whether this is a trend or a bit of an outlier in the context of the strength of that print in the second quarter.

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

Obviously, a really strong quarter here. So I wanted to ask my question on Epioxa. And I would love if you could talk about the cadence of prior auth submissions you saw in the second quarter. Did you see any uptake in activity as the J-code became effective here in July? And then how is the backlog of eyes looking in the portal, the cases that are kind of awaiting approvals and would love some color on just the cadence of approvals as you move through the quarter and into July.

Yes, David, I think -- so let me start with the second quarter and the cadence there. As you might expect, the majority or certainly a significant portion of the $11 million of revenue that we talked about was realized towards the latter part of the quarter. And that stands the reason with an FDA approval that was at the exit of the first, it took time for some of those claims to make their way through the prior authorizations, the contracting around them and ultimately to get those approved and shipped and those treatments to happen.

So I think we're now thankfully through that part of that process. But having said that, you kind of get there in June. And then on July 1, a very important milestone, but one that does shift years for us a bit is the permanent J-code being established. So you made that progress, you got those patients treated and you did that in the miscellaneous code environment.

And on July 1, obviously, you have -- it's not a full reset, if you will, but there's a partial reset there around making sure that those patients are getting access in the contracts and both the prior authorization as well as the payment approvals are happening with that permanent J-code now in place. And so you got to start back over a little bit in that context and make it through. And that's why we called out here on this call the potential for volatility around the Epioxa and Corneal Health results in the third quarter, in particular, as we reset that.

But I'll finish this by addressing, I think, part of your question around the backlog. And that, along with the things that you heard Tom mentioned earlier in terms of the payer network, the progress we've had there, the site of care network and so on and so forth in terms of the foundations of our launch.

We've been extremely encouraged by the sheer number of patients that are being put in to seek approval for Epioxa. It makes us, I'll call it, very bullish around what this product can mean for us in the intermediate term. And the question becomes more about how do you -- how quickly can you get from where we stand today to seeing these patients get approvals and access to treatment on a more rapid basis.

Certainly, as we make our way into 2027, that will be our focus here. But the leading indicators are strong in terms of the number of patients that our providers are seeking access to Epioxa as a therapy form.

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

Thank you. Hi, guys. Congratulations. I'm wondering on your Epioxa customers, how they're viewing the Specialty Pharmacy option versus buy-and-bill. Are we seeing most go to Specialty Pharmacy initially? How quickly are they getting confidence that they're shifting to buy and bill? Because obviously, that's another driver over the medium term.

Yes, absolutely. So that answer to that question has very much to do with which site of care you're talking about. So there are clearly those institutions and groups who have the experience that are much more comfortable out of the gate with the buy-and-bill pathway, and you see them pretty much even in the early days, bypassing the Specialty Pharmacy option.

I think as you get more into the broader community-based practices, you can imagine that they lean a little bit more heavily, if not entirely on the Specialty Pharmacy option, certainly, again, in the early days. That does not mean that we don't believe over time, they won't shift some of their thinking around that versus the buy-and-bill pathway. But it's a little early, again, thinking about -- we've just got the permanent J-code here less than a month ago.

And so from that standpoint, I think for them to have that confidence, they've got to start seeing consistent and recurring approvals even through the SP pathway with individual payers before they're going to start thinking about whether they should buy and build that. So I think that will be a part of the journey here over the next several years, but one we're prepared to support.

Your next question from the line of Anthony Petrone with Mizuho Group.

Congrats on a solid quarter. I'll keep it to Epioxa. Maybe first, just on the competitive landscape as it sits today and just how it's going to evolve over time. Do you think we're in a position to gain share, I guess, from scleral lenses, which is an option here ahead of corneal cross-linking? Are you seeing those patients come in?

And then there's some combination therapies under development, some private companies out there. So if you look ahead over the next couple of years, how do you think the cross-linking specific competitive landscape will shape out, assuming we have a potential entrant again at some point next year or the year after?

Well, I think, first, it's important to remind ourselves that we're at the beginning of a pretty transformational product launch and maybe even more importantly, a seismic shift in the standard of care. And when you think about what that means in terms of driving awareness and detection and access to treatment at a different level, that's obviously a large opportunity for Glaukos and for our customers and most importantly, their patients.

Whenever you build a market like that, you do so expecting competition. And you hope that, that incremental competition comes in the form of responsible market participants who are going to invest and hopefully help accelerate that shift in overall market growth. I think when we look at it sitting here today, we should be many, many years away from market share dynamics outweighing expansion and market growth as a key consideration.

The reality is that when you think about things like sclera lens, that's really not a competitive solution. These patients often will have sclera lens even after therapy. The point is you stabilize and arrest the progression of a sight-threatening disease. And so from that standpoint, I think the fact that you've got a solution that doesn't require removing epithelium lowers the bar for patients or for providers to act more prophylactically in the treatment of the disease and put sclera lens where it should be, which is postoperatively a part of continuing that vision as you move forward after a cross-linking procedure.

So I think that Epioxa helps us in that broader initiative in terms of solidifying cross-linking as a therapy of choice. And I think ultimately, we provide the investment to meaningfully change. We've talked before about difference between doing 18,000 to 20,000 eyes where we ultimately believe the market could be as high as 50,000 or 100,000 annual eyes in any given year that's potentially addressable. But we've got to go do the work to build that market the hard way and prove that to ourselves and to you all.

And I'll add on to what Joe is saying. This is Tom. And we spend lots of time and effort building new marketplaces. So you can imagine we spend considerable time figuring out how to protect our market share and how to grow these marketplaces over time. And so it's important to point out not only how much progress we'll make with Epioxa in the near term, but we already have a second or we call now a third-generation customized topographically guided eyeline therapy that's going to be in clinical trials in 2027

And if that product performs as well as I think it will and can, we could have a product that has demonstrably greater reductions in Kmax than even what we're seeing with the current methodologies and a preferential treatment of the peaks to allow us to create the ultimate kind of sphere in refractive indices that may be able to throw off even better best corrected visual acuity.

So you can imagine not only would any competitor have to deal with a really formidable commercial team that Joe has put together, but we'll have to then have to deal with a demonstrably possibly far better approach that we will have just in the near term. And so you can imagine in our contemplation, if we spent the time and effort to build this marketplace, we will spend that time and effort to protect it as well.

Your next question from the line of Yi Chen with H.C. Wainwright.

Yi, are you there? Maybe on mute.

Yes. Apologies. Can you hear me?

Yes.

This is Katie on for Yi. Just real quick on looking at readministration and TREX. Is what you're seeing what you kind of expected from early reimplantation data? Are you seeing any cannibalization on the devices?

I'll start, if Tom wants to add something he can. I think as it relates to readministration, we're continuing to see successful procedures get done. Obviously, it's still somewhat limited because these are really for some of our earliest commercial patients that are just now getting the window where you see that. But where they're eligible, we're seeing them get done and get done successfully.

I don't see anything there in the context of cannibalization. I see that as additive in terms of the physicians and those patients determining that they want to stay on the therapy as the initial iDose wears off. And if you think about in the context of iDose TREX in the future and the approvals there, I think that's only additive in the context of that overall algorithm for getting those patients on therapy, both initially as well as during a readministration procedure.

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

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

This concludes today's call. Thank you for attending. You may now disconnect.

Welcome to Glaukos Corporation's First Quarter 2026 Financial Results Conference Call. Copies of the company's press release are and quarterly summary document, both issued after the market close today, are available at www.glaukos.com. [Operator Instructions] 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 and CEO, 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. [Operator Instructions]

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, for 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 to 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 2 transformational growth drivers, including the continued advancement of the interventional glaucoma treatment paradigm with iDose TR and launch of Epioxa, establishing a new standard in interventional cardoconis and rare diseases.

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 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 of 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 mix forward as a standard of care in each region and market -- major markets in the world.

As previously discussed, we continue to expect new competitive product trialing headwinds in some of our major international markets as we progress through 2026, partially offset by growing contributions from 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 cons a rare cytidine disease that is currently far too often underdiagnosed, undiagnosed and untreated. We believe Epioxa represents a transformative innovation in care comes care offering an incision-free alternative to traditional corneal cross-linking procedures, and it does not require the removal of the corneal epithelium, the outer most layer or 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 in the health care system.

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 site threat 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 under treatment that have affected this rare disease community. As with all pharmaceutical launches, initial patient access will be gated by typical payer adoption headwinds in hurdles, 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 plants 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 or more than 100 million covered commercial lives in the United States, including with 4 of the 5 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 commercial -- or sorry, 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 on forging a new path for interventional care to come by advancing a 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 5 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 and 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 rental assets. Overall, we remain on track with our clinical time lines 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 benefits of patients. Our record first quarter performance highlights the strength of our strategy and execution as we continue evolving into an increasingly diversified atomic leader with multiple transformational growth drivers in iDose TR and Epioxa and advance our mission to transform vision therapies for the benefits of patients worldwide.

So with that, I'll open the call for questions. Operator?

[Operator Instructions] 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 sort of the claims and prior of processes are going? And two, what demand in the market looks like sort of 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, the progress we're making with the Epioxa launch, both in terms of the 2 fundamental, I think, foundational items, both our side of care network as well as the broader payer pathways. Underlying that, which I think you're asking a good question is the process of making your way through that. And 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, you will are, by definition, 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 and into our portal in the hub, as you say, as a leading indicator of what it can mean for the clinical demand associated with an Epi-On therapy like Epioxa. So as we make our way through that, and we see those claims get adjudicated, which we've seen positive claims get through the process and also those procedures get done now. We're encouraged by, I'll call the is the leading indicator in terms of that funnel as it develops.

Got it. That's great. And then Follow-up just on iDose, really solid in the quarter. Joe, maybe to stick with you, can you just talk about drivers of the strength? And it'd be great if you could maybe also discuss kind of Noridian and Novitas versus the remaining MAX and what you're seeing in kind of each of those 2 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, I'll call it, MAX. And you referenced Noridian, Novitas subset by 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. And I think also is encouraging was a real increase certainly the funnel into our hub associated with commercial and Medicare Advantage patient flow. So I think it was broad and consistent with what you would hope to expect in the context of our core initiatives.

To put a finer point, I think on your question around Noridian, Novitas, typically, I talked about that in the context of Noridian plus Novitas First Coast is some of the earlier adopting MAX. And in the first quarter, that was down to about 7% of the overall region volumes, if you will, from 78% in the fourth quarter. And again, that's really because as they continue to grow, you might expect the 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. The 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 just kind of 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 if you could give us a little bit of modeling help. And then I have a follow-up.

Sure, Adam. I'll dive in, and I'll give at least some introduced comments on that front. And if folks have additional questions, we could add in a little bit deeper. But as you said, it was a great start to the year. with really each of our franchises exceeding expectations, and we made considerable progress across all those fronts, including within interventional glaucoma and iDose in particular. And as a result, we were able to raise our guidance up to the $620 million to $635 million range. And as you think about that in your models by franchise on a handful of perspectives, first by franchise.

On the international glaucoma side, I'd say really the dynamics here are somewhat unchanged. Obviously, we expect, as we move forward here, some of the currency benefits that you heard Tom call out in the prepared remarks will weight in. And so we do expect that going forward, we'll see sort of high single-digit growth for the remainder of this year. Now when you put all that together, that's going to translate into low double-digit growth for the full year. but the remaining quarters, we would expect single-digit growth in that franchise.

On the Corneal Health side, Obviously, I think everybody knows there's a fair number of moving parts there. It was a strong first quarter. But we do continue to anticipate volatility associated with both the TREX and Epioxa transition, but also the temporary permanent J-code transition over the course of, call it, Q2 and Q3. And so when you put all together with the performance and what we're sort of seeing we now expect kind of high single-digit growth for this franchise for the entire year. with some puts and takes in the individual quarters as we get there. And as you've heard me say in the past, we certainly 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, again, another strong start to the year, we would adjust our views there probably to be more in the, I'll call it, low 30s type growth for the full year, and that's really driven by still an ongoing view that going forward we should expect kind of flattish non-high dose sales going forward until we've really been proven otherwise and continued sequential progress as we've been seeing with the iDose launch. So you put all that together, and I think as you said, we not only do we raise our overall guidance, but we raised the reach of our underlying franchises and the drivers.

I will add just because you asked about, I think, for Q2 in particular, given there's a lot going on here, and it's all good, but I want to make sure we've got it as do as possible. that for the U.S. glaucoma franchise, as I alluded to earlier, in Q2, I think we expect sort of flat non-iDose and that continued sequential iDose expansion. In interventional glaucoma, we'd expect the high single digits as we talked about that benefit wanes. And the corneal side, I think as we said on the last call, we would expect in the second quarter to see a bit of a dip there on a year-over-year basis as we transition from Photrexa to Epi-On.

Really appreciate all the color, Joe. And if I could just sneak in a follow-up. I wanted to ask about iDose and or reaching a point now where you have critical mass from a reimbursement standpoint. So Tom or Joe, can you just maybe talk about some of the new initiatives that you're going to start to put in place here. I think you've talked about growing the commercial team potentially looking at direct-to-consumer as we get into the latter part of the year. We just love some incremental color for kind of the next chapter.

Yes, you're exactly right, Adam. We've always talked about you didn't want to put some of these things into place until you start to have a more solid foundation from a reimbursement standpoint. Certainly, 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 the 5 of the 7 MAX that are now stable by professional fees and the team is driving incremental confidence both on the reimbursement side as well as, obviously, the clinical and commercial side. But also now increasingly as we move forward here on the broader commercial Medicare Advantage.

So I think as we've talked about in the past, as we move forward here, it's about driving increased awareness for iDose and interventional glaucoma and teams that help drive that broader environment of both education of patients as well as the process to get them treated by an interventional procedure like iDose. So we have been making significant investments for some time now in more of our reimbursement and business teams that surround the traditional sales force to really try to make sure that we can maximize both patient access and that broader awareness initiatives.

So I think you should expect to see more of that certainly as we get into the second half of this year and as we get closer to exiting the year and heading into next based upon this trajectory where we're going to feel, I think, a lot more confidence in starting to make some of those more offensive investments.

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

Congratulations to you. 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 2 RCPs you're running? And I had one follow-up.

Yes, I'll start off at the beginning, and Tom can comment on the broader studies that we're doing associated with iDose here in a minute. So as we think about the engagement with the MAX, I'm not sure we have a particularly different strategy here. We've always engaged in an education process to make sure they understand our technologies, how they utilize the labels and indications for use around them. And we continue to do that. We continue to try to diagnose where we've got ongoing I'll call it, less streamline reimbursement in areas like CGS and WPS, and we continue to have momentum in some of those conversations. So hopefully, we're marching forward those 2 MAX in a productive way,, they can drive professional fee establishment similar to the other 5 larger MACs that have come before them.

As it relates to the post-CAC conversation LCD conversation, really no changes on this front since our last call, Larry, and we've talked about it. 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, obviously, by nature of these things can be unpredictable and okay. So it certainly remains possible even if we believe it's less probable disappoint.

And I think to address your question on Phase IV studies, Larry, that we've contemplated actually been enrolling for some time, once we receive NDA approval, we have done 2 major Phase II studies. The first would be iDose plus cataract versus cataract surgery alone to be able to demonstrate the incremental value of using iDose in combination with cataract surgery. And that study is actually fully enrolled, and we'll be following those patients over the course of this coming year. And we'll be looking to publish the data at regular intervals. And I think that will be a very powerful supplement to the data that we currently have on hand, again, another 22 peer-reviewed clinical trials.

And then I think we were largely present in also doing a study looking at iDose versus iDose plus infinite because I want to show the incremental value of these 2 different mechanisms of action to be able to lower intraocular pressure to supremely low target pressures, which will by all evidence to be able to force the progression of glaucoma or progression in glaucoma. I think with both of these in hand, I think it will be timely in case in any event in the future, we're challenged by any magazine using either combination modalities or procedural pharmaceuticals plus MIGS or using iDose in combination with cataract surgery.

One other thing I'll just add, Larry, I think even at a minimum on this these studies that Tom's are referencing as important as the broader payer community. So this is how you continue to expand that coverage irrespective of MAX and LCDs, et cetera, with the individual commercial players in Medicare Advantage plans to make sure that we're optimizing that access for our patients.

And for my follow-up on Epioxa, Joe, I'm going to ask you kind of more of a big picture question. I think 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. And if that's paid volume, that would be well north of $1 billion in revenue. So I guess, my question is you still -- how are you feeling about achieving that? And what is the ramp to that look like?

Yes, Larry, I mean, I think I'll stop short of obviously making the longer-term predictions formally and just say I think we have been on record saying we view this as a potential $1 billion-plus franchise the pace in which we get there, we'll continue to monitor as we get into the actual true commercialization, especially if we get towards the second half of this year. But I think part and parcel of that is I don't think we view it just in the context of where we've been with Photrexa patient volumes.

We're making the investments we're making, which are enormous moving forward to drive increased awareness and detection and ultimately action and access in the hopes that we can treat, quite frankly, far more than that. We believe that there are more than the 18,000 to 19,000 eyes at any given time that should be getting diagnosed and treated. And so from our standpoint, a lot of the DTC and the things that you've heard Tom reference, we'll be putting those investments towards hopefully growing this overall market from a volume perspective over that period of time and getting more and more of these patients treated.

And I would just add on that, if you think about what the possibilities are to build this marketplace over the planning period, and it's really important to be able to recognize what we have beyond this planning care, certainly at the tail end of the planning period, this would be the second-generation customized algorithms that we have in place for the treatment of keratoconus that can't help but the market expanding if we show demonstrable changes in K-MAX for these patients. and have the possibility of actually increasing their best corrected visual acuity by virtue of customized algorithms that we're going to be able to dispense and use on these patients with keratoconus.

So I'm very bullish not only on the near term of all the different mechanisms we're putting in place to build the marketplace, but our possibility of having a second wind moving into the 2030s, which will increase our presence in this rare disease.

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

Congrats on strong start here. Just kind of dovetailing on some of the questions before. There's been obviously a lot of investor concern about these LCD risk. I know you just addressed it. But Tom, I guess my question is around the existing body of evidence. I'm wondering if you could kind of talk about it in contrast to the Phase IV study. And remind us what percentage now that we have quite a track record with iDose, what percentage are you seeing today either in combination with cataract or with another MIG in terms of the iDose usage? And if some of the studies already bear out evidence of combinatorial usage of iDose with other products or procedures, do you think that is sufficient or the Phase IV study is really necessary to kind of refute any concerns there?

I'll let Joe start and I might add some color. Go ahead, Joe.

Yes. I'll start on the -- in the context of the trends that we've seen. Certainly, I think they remain consistent, Ryan, with the past commentary. The relative percentage of the procedures done today where surgeons are treating glaucoma with iDose and at the same time, in conjunction with the cataract procedure, it's growing as expected, given obviously, Glaukos has already changed the standard of care for those patients. But at the same time, our efforts remain focused on that interventional glaucoma opportunity, and we continue to see rapid growth in the number of stand-alone procedures.

So I would say that the majority of patients last year still saw a stand-alone iDose procedure, but the mix is certainly shifting towards in combination with cataract or in combination with another mix as you might expect, because these physicians are trying to obviously do everything they can to slow the progression of the sight-threatening disease.

And I would just say, based on the question that you have, most of the Phase IV studies we do and as Joe has mentioned, are really for the payers and for moving into commercial payers and Medicare Advantage. I think surgeons a priority already have the confidence that putting iDose in combination with cataract surgery is going to yield an incremental effect. I think that you will see that in any channel actually do. Likewise, the use of combination therapy of iDose plus an iStent infinite, surgeons will have high confidence that they're going to treat incremental effect. So the studies we're doing are less to be able to drive that portion of the market. They're more to validate surgeons already existing confidence in using these technologies together.

Understood. And then maybe a question for Joe and Alex even, which is just operating expense guidance and your thoughts on profitability. I mean it's almost getting to a point where despite your best efforts, you will become profitable in kind of the next year. And I'm wondering kind of how you think about the ramp in sales -- or excuse me, the ramp in expenses needed for Epioxa commercialization and kind of what that does or doesn't do to your time lines or at least in our model, our time line to profitability?

Ryan, it's Alex. I'll start, and I'll start with profitability. Again, just to reiterate what Tom had mentioned in his opening remarks, our near-term focus in managing the business do so on a cash flow breakeven and driving basically operating leverage within the P&L, which we're pleased to say we saw in the first quarter, and we're glad that, that execution is happening. But as we look ahead to your point, we certainly can see with the commercial launches of iDose that we definitely have a fairly clean line of sight towards that pathway of profitability over the next few years.

To your point, some of it will depend on the ramp of these commercial launches and the associated revenues that come with it. But as we continue to manage the business towards that cash flow breakeven, you'll see from an operating expense side that we continue to reinvest in the business and reinvest in these commercial launches. And we've talked about the fact that our operating expenses will grow this year, year-over-year. And we feel that way. And I'll just give you some commentary now that as we did overachieve in the first quarter, Tom and I and Joe have talked about adding additional fuel to fuselage and these commercial launches. So you should see the operating expenses tick up slightly and modestly from what we talked about at the beginning of the year, but still in the high teens and still showing that operating leverage overall as we progress throughout the year.

I think, Ryan, the overall -- when you hear Tom and I talking about the incremental spending from DTC or otherwise, it's important to note that, a lot of that is by its very nature discretionary. So as we look forward, you're thinking about making those investments alongside the significant growth that we're achieving and hopefully with the hopes of a return on investment that makes that certainly worth the incremental spend associated with it.

So we'll be in a process here where we're continuing to evaluate the effectivity of those efforts and what that return looks like before diving in with 2 feet, if you will, to go full spend on DTC related efforts. We've always been pretty disciplined in how we thought about those types of things.

Your next question comes from the line of Allen Gong with JPMorgan.

Thanks for the question. I wanted to start off with one actually on the core U.S. glaucoma business. I think iDose clearly had a really strong quarter, but underlying years glaucoma also did quite a bit better than expected and grew at a healthy clip year-over-year. albeit also a bit of an easy comp, I believe. So when I think about your forecast, your reiteration for flat for 2Q and the year, what are you seeing that kind of supports that outlook? Is it just conservatism? Or are there real challenges that you're seeing out in the market?

Yes, Allen, thanks for the question. I mean you're right in the context that this was the second straight quarter where we've seen about the restoration of growth in that non iDose [ remainder ] or as you said, I think, core U.S. glaucoma franchise. So I think we've certainly seen signs of stabilization of the underlying market there. And I think that our teams are doing a great job in -- on the performance side within that more now more stabilized market. As we go forward, I think we're just not ready yet to make that call. that, that is, I'll call it, the new normal that we're operating in. It's been an encouraging 2 quarters. But as we look forward here, I think it's still safer for us and for investor expectations to be in that sort of more flat year-over-year basis until we've proven otherwise on a sustained basis.

There are some things in there. Obviously, I think we benefited a little bit in the quarter from some supply chain disruptions on the competition front. It's hard to measure that. I don't think it's material, but that should subside as we move forward here. So I think we just want to play a couple more innings here of this on that side before we rerate our view on guidance there.

Got it. And then, I guess, a follow-up, moving on to Corneal Health. You talked about how you've reached coverage of 65% of the U.S. population with line of sight to reaching 95%, I believe, the number was. How quickly do you think you can get to that 95%? Is that a target you think you can reach by the end of the year? Or is it going to maybe slow down a little bit now that you grab some of the low-hanging fruit?

Yes. Thanks, Allen. In some ways, it's actually been accelerating, as you might imagine, once you announced commercial availability and the transition plan becomes more real. What we've seen is more of an acceleration than a deceleration on that front.

Having said that, you also know that hospital systems and even certain other customers have longer cycles for bringing on new technologies and new drugs to the pharmacy network and the like. And so I think we'll continue to make substantial progress here every month and certainly hope that we're getting there or close to that target in terms of realized side of care network by the end of the year.

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

Maybe I could just start on Epioxa here. Could you maybe talk to us a little bit about some of the specific market development efforts that you have underway. And maybe you can kind of break them into whether it's physician and practice education, patient assistance programs and then engagement and education with payers?

Yes. Sure, David. It's Joe. On the Epioxa side, I think about it kind of as follows. So I won't repeat what Tom has already said, and we comment on. There's a foundational element that's first and foremost, when you're kind of going through the stage of a launch. And that is that you get the Sidecar network established, affected trained and everything ready there. The second layer of that is that you're engaging with the payers in a way to establish access pathways and then ultimately from there, further streamlining and optimizing those.

And then as you go alongside of that, you start to dial up, I'll call it, the more physician-related and even patient-related marketing efforts. But you don't want to do that too soon in that life cycle until really the overall ecosystem is ready. So a lot of where we're at right now is around the last part of what you said, which is making sure that as we're having success with the site of care network and on the patient side, that the machinery in the middle is working as efficiently as possible to make sure that we're working things through the hub and through our specialty pharmacy, and we're providing that visibility to our customers and to our patients, that our co-pay assistance programs are working as they're intended. And all the stuff that probably is a little less interesting to investors but are -- is critically important to the ultimate success here as we move forward.

And as I mentioned earlier in the call, we're really encouraged by that initial burst, if you will, of patients that are going in there. And now we have to get through that process of trying to get them on therapy which can be a lengthy one when you're dealing with a miscellaneous J-code. And so navigating that is paramount for us before we get obviously the formal J-code in the second half.

Very helpful. Maybe just a follow-up here on iDose. And I know you talked a little bit about this, but could you just talk to some extent whether there was any contribution here from having the reimplantation approval that came early in the first quarter? To what extent that may be giving physicians increased confidence implanting iDose? And how we should think longer term about the interplay between having the readministration label as an iDose TREX?

Yes. Well, I can confirm that we've now seen numerous successful readministration procedures as some of those earliest patients are getting out several years. It's not the predominant procedure being done. It's still a small fraction, but we've seen multiple surgeons do readministration and do so successfully. We've seen payer policy updates occur and a lot of, I'll call it, general progress on that front. So I think we're encouraged, and this is sort of in line with what we always expected that has the benefits of the initial procedure start to wane that both the patient and the provider are going to want to continue that therapy given the clear benefits to the patients. So we're seeing that start to happen.

And I think as we look out over the long run, certainly, readministration becomes a much more material part of that overall mix. every month and every quarter that we move forward here, it should be more and more relevant to what we're looking at. But out of the gate, we're encouraged by what we're seeing.

Your next question comes from Richard Newitter with Truist Securities.

Congrats on the quarter. Just wondering if you could give us any kind of color on what's happened to the provider base as this transition to Epioxa is taking place? I'm not looking for you to necessarily give us a specific number of doctors or your installed base per se. But do you guys envision just a big concentration over the next few quarters in a small number of providers' hands to getting all of this refined and figured out from a consistency on the payment standpoint? Or is this potentially going to be broader and not as concentrated than maybe what I'm suggesting, as we think through this? Just trying to get a sense for is it really a dramatically fewer number of doctors? Or is it going to be potentially broader than that?

I appreciate the question, Richard. I think -- well, first, I think on the definition of how you do concentrate it. I mean I think relative to our iDose user base, for example, inherently in keratoconus even with Photrexa, you had a relatively concentrated group of centers and sites that were doing the procedures. Now I won't surprise you and I think that with Epioxa, it was our intent, obviously, to make sure that your initial site of care network is as concentrated as you can reasonably be to try to make sure you're close enough to the vast majority of the U.S. population.

So inherently, our Wave 1, if you will, efforts have been very targeted around the country in that context. But I'll tell you, in some respects, our wave 1 efforts have gone maybe a little too well. And that's caused us to have to accelerate some investments to meet the needs of that customer base and their patients that are coming out of that. So there will always be earlier adopters than mid adopters in a launch, and we'll see that here, obviously, part of Epioxa. But I'm not particularly concerned about any significant concentration issues in any 1 or 2 or even 10 customers. I think it's going to be measured much more in hundreds of customers ultimately than it is in single digits.

Yes. That's helpful. And then is there any one area where the spend that you're stepping up from a position of offense, clearly is directed now that you've had some early learning experiences? In other words, where are the frictions most notable either to a doctor not wanting to do this, not wanting to buy Epioxa and move forward? Or is it more on the pull side from the patients and the demand awareness increase standpoint?

Yes. I would say it's actually maybe a bit more -- and so if you think about this, whatever -- there's always going to be conversation in education, both the sales force and the broader teams to make sure people understand what we're doing, why we're doing it, how we're doing it as it relates to the Epioxa launch. And certainly, in the future, as we've talked about, there'll be a lot more of that spend oriented towards, I'll call it, more growth and DTC education related. Right now, in this moment, where a lot of that spend is going, it should surprise you, is much more in that initial lift, confidence and process associated with claims prosecution and adjudication. It's about making sure that customers understand how it works that they're successfully seeking prior authorizations that were supporting that process where appropriate to plan and then ultimately getting those patients access to that care. So a lot of it is much more in the machinery, I'll call it within the market access world than it is necessarily in marketing or even sales from that standpoint.

Your next question comes from the line of Mason Carrico with Stephens Incorporated.

This is Harrison on for Mason. Would you be willing to provide some color on the utilization of the various cohorts of surgeons trained on iDose? Is there portion of the surgeon base today that you would say has matured at this point with more stable utilization? Or are you still seeing pretty robust utilization growth across these older cohorts of surgeons, too?

Yes, Harrison, I'm not sure I would say that we're reaching stabilization, if you will, in any one cohort. I mean if you think about it, even for some of the earliest adopters, there's still ongoing enhancements to how they think about interventional glaucoma, the amount of time they're spending on that versus other areas of their practice, let alone, as we talked about coming into this year and again on this call, the movement from, I'll call it, the more traditional fee-for-service patient population into the commercial and Medicare Advantage world.

So I think we continue to see growth across both our more mature customer base as well as certainly with the addition of new surgeons and new practices throughout the country. So we're still pretty early in that overall evolution curve, if you will, of this launch.

Got it. Yes, that's helpful. And then second question here. Could you update us on the progress you've made this year from a commercial payer standpoint on iDose? I think the middle of last year, you called out more than 50% of Medicare Advantage and commercial policies had a positive policy in place. Where does that percentage stand today?

Yes. So I'm not sure it's changed a significant amount in this past quarter, but just to put a line of sand sitting here today with iDose, we have about 99% patients have an access pathway in the commercial and Medicare Advantage arena. To the point you made in your question, about 50% of those patients are in plans where there's a specific policy attached to it and the remainder, where there's silence, we're certainly seeing successful pull-through on that. I'll also add that in these, I call the early days of the real efforts here, we're seeing a very, very high success rate in the context of the prior authorizations that are submitted for these patients across that landscape, which is what you'd expect given the statistics I just got done citing around the broader patient access pathways.

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

Congrats on the quarter. I wanted to start on the specialty pharmacy channel or with RCM. So I mean, I imagine the docs doing Epioxa were previously doing buy and bill with Photrexa. So maybe you were seeing you. So what's the feedback been from them in terms of process and whether there's any friction in that kind of change of workflow?

Yes, David. So I think that historically speaking, with the mix, there were certainly those customers who prefer to buy and bill Photrexa and those customers who acquired it through the pharmacy channel, in this case, in our case, Orsini, and that continues going forward. I think it will surprise you that certainly amongst our nonhospital-based customers the vast majority, certainly out of the gate are choosing to access the drug via our specialty pharmacy. And so that does mean some of them are doing this for the first time with our channel.

I think it's a little too early to comment specifically around that dynamic because, again, as what I said earlier, when you're in the miscellaneous code environment, even with a perfectly streamlined, I'll call it, hub and specialty pharmacy process, the process to getting that access for the patient is much more elongated. And we've only had the drug on the market now for a month. So from that standpoint, I think we're still in the early days of adjudicating those claims and getting access to the drug via the SP channel. But more to come on that. And we're certainly encouraged with the work that Orsini's been doing to make sure that they're in network with these various plans. And I think ultimately, that's going to accrue to the benefit of our customers who choose that channel.

Great. And then maybe one for Alex, just on the group gross margin. So maybe remind us what your expectations are for the year. And then as we go through iDose and Epioxa looking to next year, kind of how we should think about gross margin potential?

You bet. Thanks, David. I mean -- we saw 84% margin in the first quarter, which was up 120 basis points from last year. So we -- that was please to see that. In the last call, we -- I gave a range for the year of an expectation of 84% to 86%. And sitting here today, we still continue to feel comfortable with that guidance range for the year with expected accretion over the course of the year as products like Epioxa become a greater share of the mix.

And then to your point, looking forward in 2027, we'll comment more further when we get closer, but you would expect accretion as these products continue to ramp.

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

Thanks for squeezing me in here. So just a follow-up on the Epioxa specialty pharmacy question. I mean, when you think about buy and bill, understanding that specialty pharmacy is coming first, can you talk about options that you may have or are evaluating to enable or efficiently enable buy and bill for Epioxa down the road?

Yes, Michael, I, probably, won't go too far into the details around that. But obviously, there's always an ongoing education process around from our reimbursement teams and the experts within that as well as some of our site-of-care teams and the like to make sure those customers understand how the buyable process will work, the key terms and conditions that we have in terms of our payment terms and things like that to make sure that we can enable that where customers ultimately choose to buy and bill the drug. Obviously, when they think about it from a business standpoint, that can be an attractive option to them when they've got the right building blocks in place to enable buy and bill activity.

Got it. Just a quick follow-up on iDose Trio. What's the latest and greatest there in terms of time lines and where we stand.

Yes, I'd be happy to address that, Michael. The -- as we said before, we would complete and we have completed the clinical study for iDose Trio. We'll monitor those patients over the course of this year. We plan to file by the end of this year, and we expect to be in position for targeted approval in the fourth quarter of 2027. So we're hitting on all marks in all cylinders. And as we talked about before, when we did our human factors analysis, we saw a real strong preference for this new design on the order of 90%. So we're encouraged about what we think we'll be able to bring to the marketplace. And more encouraged by the ability to drive in-office use over time.

Your next question comes from the line of Joanne with City.

Can you hear me okay?

We can.

Excellent. Now when we do some of our due diligence on IDS, Physicians are still pushing back or pushing back, maybe still is a wrong word, on the price tag of it. And honestly, I'm a little confused by that since you do have the J-code and you do have the reimbursement in place. So I'm sort of curious what your initial reinterested like and what the responsive to that.

Yes, Joanne, I think -- I mean, you'll always have customers with varying views, but I'm not so sure that, that's really a material of a driver today as it was when we launched. Any time you launch a pharmaceutical like we have with iDose or Epioxa. There's a period where you have to make sure that your customers understand the why and how, right? But at this point, sure, there will always be some of that. But for the vast majority of the customers, certainly, you can see with the results, we continue to add them and drive that forward. We can continue to overcome that challenge where it represents itself.

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

Just a couple of quick ones on Epioxa. First, as it relates to the transition from Photrexa, are you still anticipating it Photrexa to fully sunset by the end of 3Q? Or has there been any change in that plan?

No change and consistent with what we've communicated to our customers that we would expect in the third quarter to have that transition taking place. And ultimately, we will have Photrexa available in limited quantities through a different mechanism where their physician may require an epi off-based procedure thereafter. But I wouldn't call that out as a real material consideration for certainly the commercial aspects of it for you all. But for those physicians who seek ongoing access to Photrexa. We do have a pathway which we're going to make it available then.

Great. And then obviously, we're at the beginning of the runway with Epioxa in the U.S., but just thinking longer term, what is the potential for expansion of your platforms outside of the U.S., whether it's Photrexa or with Epioxa.

Yes. I think it's -- it has to be much more selective, and it won't surprise you, Steven that today's environment where you're navigating a combination of reference-based pricing initiatives as well as other things in terms of payer dynamics and the like. There are certainly some markets internationally that can support the type of therapies that we're talking about with Epioxa and with iDose. But also, we'll have to continue to evaluate that as the landscape shifts that we bring success for generations of products forward. and bring as much of this technology over time as we can internationally. But it's not something that at the moment I would be factoring in any material way into your models.

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

Congrats on the quarter. Maybe one on just keratoconus just broadly, when you think about the disease state that it's just -- it's underdiagnosed you're getting most of these patients that come in with Stage 2 severity, just thinking about the Epioxa opportunity, what is the really true TAM from a patient standpoint in terms of this disease state? I know it's kind of considered an orphan disease, but I think the prevalence probably stretches to somewhere between 80,000 and 100,000 patients. So what is the true TAM in terms of prevalence in the U.S.? And what is the diagnostic pathway to get more patients into the funnel?

I think, Anthony, it's a great question in the context of exactly the why behind what we're trying to achieve here. So when you think about keratoconus and as a condition in where we've been, the 18,000 to 20,000 eyes that happen getting treated, we believe is likely going to be proven to be a fraction of what really should be getting caught should be driven to detection and ultimately into therapy over time. I think our best estimates here suggests that there should be between 50,000 and 100,000 keratoconic eyes a year at a minimum that are getting diagnosed and treated with Epioxa cross-linking. And -- but we're going to have to find that number out ourselves as we move forward with increased debt initiatives around awareness and detection and ultimately access that therapy. But we do believe that over time that this could be proven to be more of a rarely diagnosed disease than a rare disease. But today, it operates like a rare disease and we're going to make those investments 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.

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to Glaukos's Fourth Quarter and Full Year 2025 Financial Results Conference Call. [Operator Instructions]

I would now like to turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Chris, please go ahead.

Thank you, and good afternoon. Joining me today are 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 U.S. and international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations.

These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.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 the most directly comparable GAAP financial measure.

With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns.

Okay. Thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glaukos reported record fourth quarter consolidated net sales of $143.1 million, consistent with our pre-announcement last month and up 36% on a reported basis and 34% on a constant currency basis versus the year ago quarter.

For the full year 2025, consolidated record net sales of $507.4 million grew 32% versus 2024. We are also reaffirming our full year 2026 net sales guidance range of $600 million to $620 million, which implies continued strong year-over-year growth of more than 20% at the midpoint. Our record fourth quarter and full year results reflect a highly successful year of global execution across our key commercial and development initiatives and underscore the dedication of our global teams strength of our differentiated technology platforms and our evolution into a more diversified ophthalmic leader.

From a corporate perspective, 2025 was a milestone year. In addition to surpassing $0.5 billion in annual sales, we celebrated our tenth anniversary of our 2015 IPO, surpassed on 1,000 employees worldwide and broke ground on a new facility in Huntsville, Alabama.

As we enter into 2026, we are well positioned to sustain our strong growth momentum, led by 2 transformational growth drivers, including the continued advancement of the interventional glaucoma treatment paradigm with iDose TR, along with the launch of Epioxa, opening up a new paradigm in interventional [ Karaconas ] and mirror diseases. These 2 highly differentiated and durable market opportunities underpin our confidence to deliver a best-in-class growth profile, extending well into the next decade as we continue to invest in and advance a robust industry-leading pipeline while remaining disciplined in capital allocation, focusing on ROI-driven investments and cash flow.

Our record fourth quarter results are a testament to the progress we continue to make in advancing our mission to transform vision therapies for the benefits of patients worldwide. Within our U.S. glaucoma franchise, we delivered record fourth quarter net sales of $86.4 million on strong year-over-year growth of 53%, driven by growing contributions from iDose TR which generated sales of approximately $45 million in the fourth quarter. iDose TR's positive clinical outcomes continue to generate momentum of sales of approximately $136 million in 2025, reflecting strong physician adoption, reaffirming the compelling patient impact of this game change in therapy.

Operationally, our teams continue to execute well on all on our plans, focused on growing training surgeons and accounts, increasing utilization, broadening market access, expanding the clinical evidence and accelerating targeted marketing investments. We believe iDose TR remains early in its overall adoption curve with significant value yet to be unlocked as we expand market access and build on the progress in 2026 and beyond.

Last month, we were pleased to announce that the U.S. FDA approved our NDA labeling supplement, allowing for unlimited re-administration of iDose TR in patients who maintain a healthy cornea. We welcome this important labeling enhancement and believe it should help expand access for patients who may benefit from a repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time. With iDose TR as the foundation, our goal to advance and improve glaucoma treatment by driving earlier intervention continues to gain steam as we educate surgeons and thought leaders globally to organically drive this broader evolution in the standard of care for the benefits of patients. While we remain in the early stages of these interventional glaucoma efforts, we are encouraged with the increasing levels of clinical interest for this paradigm-changing evolution.

Moving on, our international glaucoma franchise delivered net sales of $32.8 million on year-over-year growth of 18% on a reported basis and [ 13% ] on a constant currency basis. This strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward as the standard of care in each region and major market in the world. As previously discussed, we continue to expect new competitive product trialing headwinds in some of our major international markets as we progress through 2026, partially offset by growing contributions from iStent infinite following its EU MDR certification and associated European commercial launch late last year.

And finally, our corneal health franchise delivered net sales of $24 million on year-over-year growth of 12%, including [ Fortrex ] and net sales of $21.4 million. As you know, during the fourth quarter, we were delighted to announce the FDA approval of Epioxa, a novel groundbreaking advancement in corneal cross-linking for the treatment of [ cardikonas ], a rare sight-threatening disease that is currently far too often undiagnosed and untreated.

Interest from the physician community following approval has been very encouraging and reinforces our view that with Epioxa, we are [indiscernible] in a new standard of care for [ caracons ] patients and practitioners with the first and only FDA-approved topical drug therapy that does not require remove up the [ cornepicilium ], the outer most layer of the front of the eye.

As a reminder, Epioxa utilizes a proprietary combination of an oxygen-enriched novel therapeutic that's bioactivated by UV light in an incision-free procedure. It is the result of more than a decade of research focused on slowing or halting the progression of [ keratoconus ] while significantly improving patient comfort and minimizing recovery time to provide a new way forward for patients afflicted with this [indiscernible] rare disease.

As we've discussed, the FDA approval of Epioxa has allowed us to reset and redefine our go-to-market approach to better address this sight-threatening disease and truly expand patient care and access. Immediately following approval, our cross-functional teams commenced execution of our detailed methodical initial commercial launch plans ahead of Epioxa drug availability expectedly in this quarter. Importantly, with this launch, we plan to substantially increase our investments in patient awareness education and access while addressing the long-standing challenges of under-diagnosis and under-treatment that have affected this rare disease community. Our efforts are designed to support patients and families at every stage from awareness and diagnosis through ongoing treatment, taking the entire journey of seamless, efficient and patient-friendly as possible over time.

As with all pharmaceutical launches, initial patient access will be gated by our site of care network deployment and typical payer adoption headwinds and hurdles, but we're investing in the infrastructure teams and processes necessary to get Epioxa as to many patients as soon as possible in 2026 and beyond. We've been encouraged by the progress we've made in short order following approval.

First, I'm proud to report we are ahead of schedule in establishing our Epioxa sights of care network. Our early Wave 1 efforts are yielding results when acquired [ OTN ] systems already actively deployed in locations covering nearly 50% of the U.S. population and a broader pipeline of systems moving through the approval processes that would expand our treatment center reach closer to 90%. Looking ahead, we will continue evolving this network to bring treatment access close to patients as reimbursement and drug acquisition pathways become further established and streamlined.

Next, on the market access front, we have completed our initial payer communications and updated key payer databases with the details associated with the Epioxa, launch. Our payer team is already actively engaged today with insurers, representing approximately 50% of commercially covered lives in the United States, including 4 of the top 5 commercial payers. As a result, we have seen several early positive coverage determinations spanning across Medicaid and commercial payer landscape. We successfully submitted for the Permian J code and expect it to become effective in July of 2026. Based on the CMS cycle for [ Jos ] until then, we anticipate Epioxa will be commercially available under a new technology miscellaneous J code, anticipate measured adoption over this initial period until the [ Permanent ] J Code is in place.

In addition, we've also rolled out various new patient services and support programs led by our patient access liaison teams signed to streamline care coordination, demystify the insurance approval process and advanced covered decisions where possible. Our teams are also deploying new marketing and DTC campaigns designed to significantly enhance awareness, education and detection driven by increased engagement with the optometric community, the development of a handheld KC screening device and expanded advocacy partnerships alongside new patient education efforts to identify and reach patients earlier.

Finally, as we've discussed with the launch of Epioxa,, a critical focus of ours is to improve patient access to the sight saving [ cericomas ] treatment. On that front, we have successfully deployed a new financial co-pay assistance program for eligible patients and operationalize a comprehensive specialty pharma option available for our customers at launch. As you can see, we are very excited by the significant potential Epioxa offers to patients living with [ caritaconis ] and believe it will deliver an exceptional value to patients, providers in the health care system. This enthusiasm was on full display during our recent national sales meeting, where anticipation for Epioxa's availability later this quarter was comparable.

We're probably in the way once again in forging a new path to drive expanded patient access and enhanced treatment standards. Beyond Epioxa, we continue to advance a broad and differentiated clinical pipeline across our 5 novel therapeutic platforms with several noble milestones. Within our iStent surgical glaucoma platform, we completed patient enrollment in a PMA pivotal trial for iStent infinite, in mild to moderate glaucoma patients during the fourth quarter and continue to advance a 510(k) pivotal study for the [ PreserFlo ] microchip.

Within our iDose platform, patient enrollment is well underway in the Phase IIb/III clinical program for iDose [ TREX ], our next-generation iDose therapy with initial results of our Phase IIa clinical trial demonstrating substantial IOP reductions of 8.6 to 10.8 millimeters of mercury through 3 months. In addition, we recently commenced a Phase IIIb study for high-dose [ Trio ] and continue to advance several Phase IV studies.

Within our [ iLink ] platform, we plan to bring a screening tool to market later this year and initiate a Phase III program for our third-gen [ iLink ] therapy next year. Within our [ ilution ] platform, we commenced a Phase II study for [ iVision Demodex ] blepharitis in the fourth quarter. And finally, within our retinal platform, we recently completed enrollment in a first-in-human clinical development program for [ GOK ORAN ], our intravitreal multikinase inhibitor retinal program in patients with wet AMD.

Despite being a relatively young company, Glaukos has invested over $1 billion in R&D since inception to develop a robust pipeline focused on chronic and rare ophthalmic diseases. Our continued investment in R&D remains best-in-class underscoring our commitment to growing first and advancing the standard of care for [indiscernible] patients worldwide into the future.

In conclusion at Glaukos we're the business of pioneering entirely new marketplaces within ophthalmology. Innovation is at the core of everything we do as we advance our mission to transform mission therapies that can meaningfully advance the standard of care and improve outcomes for patients suffering from site-threatening chronic eye diseases. Our mantra will go first embodies our commitment and determination to take chances, push limits of signs and disrupt the legacy of treatment paradigms in glaucoma, rare disease and retinal diseases through our pursuit of game-changing innovation.

Our record fourth quarter and full year 2025 highlights the strength of our strategy execution as we continue evolving into a diversified ophthalmic 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?

[Operator Instructions] Your first question comes from the line of Tom Stephan with Stifel.

Great. First one on Epioxa. Tom, you mentioned early positive coverage determinations from commercials and Medicaid, I believe you said. Can you elaborate on kind of the key highlights here a bit? And then just broadly, to what extent has there been any payer pushback on pricing of Epioxa and/or the [ Photrexa ] discontinuation?

Tom, it's Joe. I'll start off there. Tom want to add comments you certainly can. So from a payer standpoint, it's important to remember that really you start to get a lot more of the coverage policies in place once you've got drug in channel and you're actually adjudicating the claims. In the early days, it's all about the clinical education associated with the product make sure those payers understand what Epioxa is, what it means for patients and how that's differentiated from [ POTREXZA ] that they've obviously known for several years now.

So when he said that there's a positive development in terms of early policies, it's really because it's even a bit surprising in the context of a normal drug launch here in this case in predrug and channel, you're getting positive outcomes with a handful of Medicaid societies as well as with one of the larger blue plans out there. And so all of the conversations so far a bit much more clinical in nature. We've not heard any formal or informal pushback from payers on the pricing dynamics associated with Epioxa.And so we continue to move forward and look forward to obviously to getting the drug officially launched, if you will, and engaging on a claim-by-claim basis with these payers and ultimately getting into a place where many more have the positive coverage determinations that we expect.

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

Yes. Sure, Tom. I think from an iDose perspective in the fourth quarter, and we talked a little bit of this in a recent conference. We did see a couple of factors up so we did continue to grow sequentially and grow nicely. I think it was north of 10% sequentially. But underlying that were a couple of dynamics we're calling out. But the first is that in the fourth quarter, and this is learning a little bit for us in the context of iDose, the mix shifts a little bit towards Medicare Advantage there's a lot more volume done in the fourth quarter typically than ophthalmology. But because a lot of those benefits, and I'll call it the piece on of-pocket dynamics and related, you tend to see a little bit more on the Medicare Advantage side relative to the fee-for-service patient population.

And then second was just some specific things to Glaukos and I'll call it our rep incentive that in looking back, we saw probably a little bit of pull into Q3 and a little bit of pullout into Q4 that on the margin, I think, also impacted that. If you think about translating that moving forward, I think what I would say is we do expect continued progress sequentially into the first quarter with iDose despite it being a seasonally low quarter from procedure volumes. And as the overall year, which we can talk more about throughout your matter, we expect there are going to be continued sequential improvement each quarter throughout the 2026 time period.

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

Congrats on all the progress. Maybe picking up, Joe, a little bit where we just left off. I wanted to ask about top line guidance for FY '26 to $600 million to $620 million and really just hoping you can kind of pull apart some of the different components, whether it's iDose contribution, how you're thinking about the U.S. stent business and corneal health with Epioxa. Any quantitative color would be fantastic, but even just broad qualitative strokes such as we expect this business to grow or not grow would be really helpful. And then I have a follow-up.

Yes. Happy to do that, Adam, and maybe I'll start off. And obviously, if you follow up questions or others, we can dive a little bit deeper. But if you think about the guidance that we've set and kind of affirmed here today, which is normally the time what we said is the first time, as many of you know, there's no question 2026 is another pivotal year for us as our efforts as you heard Tom say to transform the standard of care and interventional glaucoma with iDose and iStent infinite are kind of now finally joined by what I'll call a complete reset and expansion of our investments, the launch of Epioxa.

And so we were pleased to be able to establish an initial guidance range of $600 million to $620 million, which at the midpoint, represents more than $100 million of growth in this year. If you think about it by franchise, I think it's probably the easiest way to start, on the international glaucoma side, we expect high single-digit growth internationally for the year as competitive launch headwinds really play themselves out in several of the key markets, as we've talked about for a couple of quarters now and they're somewhat offset by [ Dican ] infinite launches and the broader individual glaucoma and market access initiatives that we have going on worldwide. I think in the early part of the year, that will be a little bit higher than that. And then as some of the currency tailwinds wear off, we would certainly expect that to come in a little bit in the back half of the year.

On the U.S. glaucoma side, we expect embedded in the guidance is growth in the 30% range year-over-year, driven entirely by iDose TR. I think as we've said in prior calls, I think it's safe to start off this 2026, assuming that the non-iDose businesses flat on a year-over-year basis. And so the entirety of that growth, I'm talking about is really being driven by iDose. And that leaves corneal health. And while there are a fair number of, I'll call it, moving parts associated with the launch of Epioxa and the transition from [ FOTREXA ], I think we can confidently say we continue to expect that the franchise will grow modestly year-over-year, but with a fair amount of volatility, particularly in Q2 and as we enter into Q3 as Epioxa becomes available and that permanent J code is established, you'll see the warehousing effect that we've been thinking about and the sort of delay as those patients are working their way through the approval process and ultimately getting approval and treatment as we kind of make our way through Q3 and certainly into Q4, where we think that the strongest results will be for that business.

That's really helpful, Joe. I appreciate all the color. And maybe just for the follow-up. I guess, another modeling question, and I just wanted to ask for a little bit more color on cadence quarterly mrealizing you just gave a little bit there. But for Q1, I had the Street modeling, I think, $132 million, $133 million of revenue, which is down sequentially quarter-over-quarter. Just curious if you have any reaction to that figure -- and obviously, Epioxa transition versus [ Photrexa ] is a little bit, I think, tough to pin down. So any more color you can kind of give us on how you're thinking about sequencing would be appreciated.

Yes, Adam, it obviously is a bit tricky on the cornea side, but I'll zoom out for a second. I think for 2026 we'll probably deviate a little bit from those historical norms that you've been around the story for a while, you know that ophthalmic procedures tend to see seasonality of, call it, 22%, 23% in the first quarter and 24%, 25% in Q2 and Q3 and then 28% plus or minus in Q4.

When you look at what's driving it for us, it's really based on the 2 primary factors you might expect. With the iDose launch, as I mentioned earlier in the call, we continue to expect sequential growth quarterly throughout 2026 that will lead obviously to incrementally a more back half-weighted iDose contribution in U.S. glaucoma number. And then from a corneal health perspective, I alluded to in your first question, but we expect to see modest growth in the first quarter as folks continue to [ forex ] procedures in advance of Epic being available.

I think we'll see a fairly material dip in Q2 as we really are in the heart, I'll call them the transition from [ KOTREXA ] to Epioxa. Those patients are being entered in for the approvals and prior authorizations, but perhaps not treated equipment, we'll start to see with the J code and as we make our way through Q3. I think Q3 will probably be a bit more of a flattish year-over-year quarter as the J code comes online, you see some of the patients moving out of the funnel and into treatment towards the latter part of that quarter. And then obviously, we would imply that as a pretty strong exit in the fourth quarter as the J code comes online and we start to see a little bit more normalized treatment patterns as we're exiting the year heading into next.

And if you think about that in the first quarter and the way you said that, I think the U.S. glaucoma business will probably be somewhat flat to Q4 as the non-iDose seasonality headwinds are offset by IDose itself expansion. Corneas, as I mentioned earlier, will probably be modest growth on a year-over-year basis and interventional international glaucoma we'll see -- it's more normalized. So I think we'll see the same high single digit to maybe low double-digit growth on a year-over-year basis.

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

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

Okay. Well, I'll start with the second part of your question, and Tom jump on readministration, he can. So as it relates to the Epioxa coverage, now remember, in rare disease and unmanaged categories, it's quite common that you won't have any formal coverage policy. You're monitoring actual prior authorizations and approvals to therapy over time to determine that you've actually got access. That assets may come in the form of formal coverage policies and it may come in informal ways just through simple adjudication patterns than [indiscernible] have the confidence that patients who seek that therapy are able to get it if they qualify. So we're ahead of that time.

And I think what Tom was saying in the prepared remarks that we've engaged in a meaningful way and clinical conversations with payers that represent over 50% of those covered lives. And as a result, we've even got some early positive policy wins. It's important to remember that cross-linking as the standard of care, we're -- that's not new, right? We've obviously been at that for some time with [indiscernible] that of procedure. And so as we move forward here, we certainly expect them to continue to recognize that and provide the access that these patients deserve on a clearly superior therapy in the form of Epioxa.

As it relates to readministration and the interplay between that and [ TREX], I think -- if you're thinking about that, the question was meant to go from a long-term kind of modeling standpoint, Ryan, clearly, the goal has always been to provide patients and surgeons with as many options as possible. And depending upon the disease severity and where things are at clinically, we certainly expect different surgeons have different algorithms around whether they choose to readminister a patient with IDose TR or [ TRx ] based upon the clinical profile that exists with [ TRx ] when we ultimately get through the FDA process is there.

And when I think about it from a modeling standpoint, Ryan, that part of that is to think about, obviously, there's a trade-off there potentially on duration. We have to prove that through the clinical trials, and there's the pricing considerations around a longer-acting therapy as well. And ultimately, I think what we land is -- most importantly, we've now or hopefully with approval of [ TRX ], would have multiple options for patients that remain on sustained pharmaceutical therapies for the duration of their life, if you will, with the disease, which the average patient from diagnosis to no longer need the therapy will be in a glaucoma surgeons care for over 20 years. So multiple shots to continue to treat these patients, whether it's with [ TRex ] or TR.

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

Well, let me step in before Joe speaks for me, Ryan, and that the 3 questions you asked. So let's talk about OpEx first and foremost. Our philosophy as a corporation still hasn't changed from what we experienced in 2025, which is we're going to continue balance our capital investments against our revenues such that we're driving towards cash flow breakeven and potentially some cash flow generation over the course of 2026. And with that in mind, you would expect to see our operating expenses have growth next in 2026.

If you think about what does that growth look like? What I would tell you today or what I would guide you to is somewhere in kind of a mid-teens year-over-year growth percentage of our base of 42 in 2025. That should put you in the neighborhood of operating expenses around 555 to 560 in 2026. Now that is still going to show operating leverage in 2026, which is another of our goals as we continue to march forward. within the business and what we're trying to achieve. So that's kind of where we're thinking. And again, those are the key things. that even though we're doing this, we have these 2 really key growth drivers that we're investing in, in Joe's organization between the iDose launch and the Epioxa launch in that. And then we have what we believe is a best-in-class R&D pipeline that we have to invest in well. And all those things are driving our decisions around our capital allocation.

And I think there's no question for all of us, Ryan, that with the Epioxa launch and the recent market whether it comes a significant investment in patient access and whether that's on the hub with the specialty pharmacy with the DTC investments or all the various things are designed to drive awareness, diagnosis detection and ultimately, the pull-through of these patients in as fast as time as possible, we're prepared to make those investments, obviously, within the framework that Alex alluded to.

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

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

Well, I think, Larry, from a readministration, we're going to have to watch that, right, in terms of those patients. I mean, certainly, we've been actually already seen our first readministration happen in the OR and it's driven by the things that you would hope to hear, which is that the patients themselves was seeking that an early patient who was getting into the area where they would potentially benefit from an incremental administration, and they were seeking it because they didn't want to go back on drops. They appreciate the value, if you will, of having the iDose working for them.

And so I think over time, we'll have to continue to [indiscernible] that. But clearly, if you go back to what I said earlier, if the average patient is in the care of a glaucoma specialist or a comprehensive doctor for a little over 20 years with the disease, we expect there to be considerable opportunity for multiple readministration within the same patients over time. And I think that can certainly be a significant part of, I'll call it, the overall mix, if you will, relative to first-time therapy. Certainly, as we get further and further out into the planning period. And I do think that there's an incremental halo effect because at a baseline, surgeons can confidently have the conversation with patients about interventional glaucoma knowing that they've got tools and solutions, including the repeat administration of iDose with those patients to manage their disease that way for hope with their lifetime.

That's helpful. Joe, on Epioxa, can you talk a little bit about how quickly you expect to upgrade accounts to the new capital equipment? And can you put a finer point on when [ FETREXa ] is expected to be completely phased out?

Yes. As you heard in the prepared remarks, we're already well down that path of at least installing the capital equipment required to administer Epioxa and we would expect that journey to continue. I think as Tom mentioned in the remarks, we've already installed or are installing capital equipment that locations that would cover over 50% of the lives in the United States. And we've got various levels of approval that various systems and providers where we'll be north of 90% as we make our way through here into the launch. So I think we feel really good about where we're at in terms of establishing that foundation, if you will, as we move forward.

As it relates to [ FOtREXA ] and the transition it makes sense, Larry, without getting too specific on dates that with a July 1 J code, we want to make sure that [ FORTREXA ] certainly remains available to physicians through that period. And then as we make our way into and through the third quarter, we'd expect to transition that more fulsomely over to Epioxa.

Your next question comes from the line of Allen Gong with JPMorgan.

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

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

Got it. And then I suppose your installed base, I think the we've already gotten a few questions on this, but your installed base of Epioxa [ H2 ] [indiscernible] is already -- it feels like coming a little bit faster than expected. So -- and there's clearly a lot of excitement and even more durability in [ PETREXA ] and, I think on -- the Street were expecting. So how -- like why wouldn't you be able to convert cases over fairly quickly, like just converting the cases you were doing on [ FOTREXO ] over to Epioxa fairly quickly once you have that J-code?

Yes. I think this is a great question, Allen. So I can confirm that our team has done a terrific job of getting ahead of even what our initial planning was around the I'll call it the installation and the procurement process associated with the [ O2N ] system and really establishing the foundation, if you will, from which we can make that happen. The reason why we talk about the guidance in the context of Q2 and Q3 and various things are there, you got to take a step back.

First, in the first half, you'll have a miscellaneous code. That comes with its own set of unique challenges associated with patient access and working your way through. The approval processes can be a bit elongated at times when you're using the miscellaneous code. And then once you have the J code established, there's the various -- you can imagine, payer notifications and things that go alongside of that. The combination of those things alongside of just the early days of the approval process, in any rare disease, let alone in this case, Epioxa means that you're going to have a fair amount of patient conversation that translates into, I'll call it, warehousing, it's not really warehousing but as they're going into the approval processes, we certainly expect those approval processes to be much more elongated as they're trying to go through that because of the miscellaneous code, because of the conversion of J-Code, because of what you expect in terms of the initial technical denials and then having to overcome those through appeals and peer to peers and all the things that go alongside of that.

It just means that you'll probably have a bit of a gap, if you will, from when those initial patient conversations happen to where you start to see, hopefully, a more normalized patient pull-through dynamic into treated Epioxa eyes.

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

I was hoping maybe we could dive in a little bit more on iDose utilization. I know you've talked about strategically prioritizing iDose stand-alone cases. But maybe can you give us some flavor on how the different categories of utilization here evolve through the course of 2025? What your expectations are for '26 and any considerations coming out of the November [ CAC ] meeting that are either reflected in your outlook or that may be percolating behind the scenes?

Yes, David, you covered a fair amount of ground in that question. So maybe I'll start a little bit in reverse as it relates to the CAC meeting and what that we do or don't expect there. I mean I think from -- so far, this process is really -- it's really aligned with kind of our expectations as the [ MAX ] somewhat understandable, we want to understand iDose TR better and a goal that hopefully was achieved during the CAC they had late last year. We've not really seen any signs of an LCD. I know there's considerations around that and continue to believe it will be premature at this stage of the launch. Of course, these things can be unpredictable and sometimes opaque.

So it certainly remains possible even if it's not probable at this point. And the guidance that we've given has multiple different directions we can ultimately achieve that. As it relates to kind of where we saw the trending from 2025 and going into 2026, from a handful of different spots, starting with kind of the [ MAX ]. As you can imagine, we continue to see more growth from the [ MAX ] where we have established professional fees. So in that sense, [ Novitas, Ceridian, First Coast ], we were pleased to see the addition of NGS to that mix in the latter part of last year, and that certainly contributed as we made our way from the third quarter into the fourth and continuing in the early part of this year, we see NGS added benefits. We have continued to see a relative percentage of procedures done where physicians are treating glaucoma at the same time as a cataract procedure increasing that was expected, given we've already changed the standard of care for those patients over a prolonged period of time.

And as we enter into 2026, I think the expectations should be kind of going back to those same things that we knock down the remaining [ MAX ]. I think at this point, I can confidently say that we're the closest with [ Palmetto ]. I think we're on the doorstep there and hope to see that in the coming days, if not weeks. And we certainly are making a lot of progress since the beginning of the year with them as well as with WPS and CGS.

And then I think I've mentioned this before, but the other big initiative for us in 2026 is really focused on driving increasing utilization in that broader patient population, it's also represented by commercially covered lives as well as Medicare Advantage.

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

Yes. I think it's a great question. I mean, first, when we introduced it, you're correct. I mean, with the pronounced change and how we thought about both the pricing dynamics as well as all the considerations around the market access element of the transition from [ Vitrex ] to Epioxa. We did want to make sure that folks didn't mistranslate that and get ahead of us in the context of the way we think it will actually play out on the ground as we make our way through 2026.

I think since that time, pretty much across the board, things have probably played out somewhat favorably but as you can imagine, even in here in the question, a lot of the things that we're talking about are later in 2026. And so whether it's a continued sequential growth and getting a feel for how that continues to play out in iDose TR or as we've talked a fair amount about the [indiscernible] dynamics, which are really largely weighted towards the second half and even the fourth quarter, it was premature despite all the positive underlying fundamentals of the [ CytoCare Network ] for Epioxa or the payer progress or even the trends that we've been seeing with iDose, I think to make any adjustments to our guidance at this early stage.

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

Two for me. I'm just curious, are you factoring in readministration at all in the sequential improvement and the color that you gave on U.S. glaucoma and we can all back into the iDose number. It sounds like you're pretty comfortable with where the consensus is based on your comments. So that's the first question. What, if anything, for readministration is even factored in there?

And I'll just ask my second one. When you talk about co-pay assistance or market access programs that you're investing in, can you elaborate a little bit more on what exactly you're doing with the specialty pharmacy access to make adoption more fluid for payers and patients or providers and patients? And are you also talking about your ability to move things through the denial process, does that denial process go away once you have the J-code in place, now it's a drug?

Sure. Richard, I think I took all that down. But if I didn't miss something, you could circle back I think it's fair to say that readministration was not a material consideration as we thought about the guidance. Certainly, as we set it back in November and then as we've affirmed it here, we sitting here today, given my earlier comments, we would expect there to be some readministration we make our way through the year. And some of those very early patients get into the window where readministration comes a viable option.

I think readministration becomes a much more material contributor to how we think about the business in 2027, 2028 and beyond than it is something that we're thinking about in 2026. And inherent in your question and from an iDose standpoint, I'll say it again, there are multiple different directions for us to try to achieve the numbers we put out. And in the context of both the existing [ MAX ] that we've got professional fees established today, the incremental professional fees that we expect to have on schedule, if you will, from the remaining 3 [ MAXs ] that represent over 30% of the covered lives out there or our initiatives that we're certainly investing a lot more in on the commercial and Medicare Advantage side. Each of those, I think, drive the confidence in the commentary, both around the overall guidance as well as the sequential improvement that we expect.

Now on Epioxa, and I'll call it the investments we're making both to drive or optimize patient access as well as turnaround time. I guess the best way you'd say it on some of the support elements is there are always, from a service provider standpoint, good, better, best type programs. And when you launch a rare disease, you clearly have to invest in the best, the best from a hub standpoint, the best level of service from a specialty pharmacy standpoint, incentivize maximizing access and driving the most experienced professionals within those organizations and [indiscernible] ground times associated with them.

I think we've been on record to say from a co-pay assistant that we'll have a $0 co-pay program for commercially covered lives that you hope that in the vast majority of cases, patients can qualify for that to make sure that, that's not an impediment to access. And again, really all of these things as well as our broader efforts that we'll have on DTC, provider and patient education are all meant to be a substantial increase in the investment we're making to drive the awareness and the detection and then ultimately, the treatment turnaround time for those patients who are afflicted with this disease.

Your next question comes from the line of Mason Carrico with Stephens.

Guys, thanks for the question. Could you quantify the number of sites that have received the equipment to perform Epioxa procedures. There were the numbers that have committed to it? I know that you called out [ O2 ] system had been deployed to locations covering something like 40% of the population. But -- should we be interpreting that as a single Epioxa site now covering a much larger geographic area than the average [ Photrexa ] site?

Yes. I mean I think I'll probably short of giving the specific numbers around the site and the various things and simply say that when you look at it, to your example, if you have a site within the Atlanta metro area, for example, that's designed to cover that patient population. And again, that's not uncommon. So when you think about the launch, you want to make sure that you've got the providers who are the best at going through the process we're about to that are committed to the care and are willing to go through the payer hurdles, if you will, and make sure that they're being properly educated.

So you focus your efforts on those while trying to make sure that you've got the geographic reach that you need. And then over time, you start to supplement that to make sure, again, that patients don't have to wait an unnecessarily long period of time to get access to care. And so I would expect -- and we're happy with where we're at for the initial launch, the way one customers, you heard Tom reference earlier are wave one for a reason. And then ultimately, over the coming months, quarters and years, we'll continue to expand that network out and be offering more and more sites within a particular geography to make sure that we're getting the access to those patients.

Got it. And then on the coverage front, I think you said you're in conversations with 4 of the 5 top commercial payers, do you believe that you could realistically have a positive coverage decision from one or more of those in 2026. Do you guys have an internal target for the number of covered lives that you could have by year-end?

Mason, I think I would take a step back to what I was saying earlier, and we'll see whether or not we have a positive coverage [ termination ] policy and a variety of other things that help expedite patient access in 2026 whether it's with those top payers or others that are out there.

The thing that we're watching most closely as we launch, is that patients are able to work their way through the approval process -- the prior authorization process with each of these payers and the broader network of payers that are out there, such that we're able to confidently believe that we've got access a pathway for the vast, vast majority of patients. That's the initial goal.

From there, you start to focus more and more on optimization, whether or not they're getting that access through the pharmacy benefit or the medical benefit whether they're getting that through on the initial prior authorization or through the appeal process and ultimately whether or not they're achieving that access through an established positive policy that provides the cleanest and clearest pathway for them to get access to the drug.

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

Great. Maybe two on the glaucoma business. First, on iDose. You talked about commercial cases. So what are you hearing in terms of doctors starting to really get into that patient population? I mean, is it kind of more of a trickle? Or are you seeing that build?

And then the second question is just on the iStent franchise. You talked about flat growth expectations for the year. I think it was I mean, is that just because of how you're incentivizing the reps, obviously, iDose is the focus right now. But what's the view there? Is that more of a market dynamic or anything around competitive dynamics?

Yes, David, I think -- so first, as it relates to the commercial, and I lump them in with Medicare Advantage because obviously, those are shepherded by commercial carriers. It's very provider specific. So in those geographies where we've obviously had the proper Medicare fee-for-service coverage for a while, we're starting to see providers turn on where they're offering it to a wider swath of patients. And for those that are good at it, we're seeing them do that in a more fulsome way.

Our efforts in 2026 are to really try to expand that in a much more significant and profound way as we make our way through the year. I think about in kind of 3 -- call it, pillars we've been talking a fair amount about payer access on the Epioxa side. It's obviously relevant on the iDose side as well. The good news is the foundation here is pretty strong. We've seen successful authorization for therapy and the payment of both the J and the T code from payers that cover the majority of patient lives including 4 of the 5 in that case as well, largest payers on the Medicare Advantage side. So I think we've got a pretty solid foundation on which to expand in terms of the payer side.

The second is process optimization. It's going to get sound fairly familiar when we're talking about Epioxa but it's been driving the entire ecosystem from our IDose Hub, our iDose SP providers to the payers and the accounts themselves to reduce the barriers and increase the patient access and optimize the time treatment for patients on that side of the house.

And then the last thing, which we talked about, not in a while, but the patient economics. Similarly, we have established programs to support commercially insured patients where most of them should pay as little as $0 a pocket. And then for MA patients, I think from the very early days of the launch, we've said that the data suggests that about 20% of those patients have no low out-of-pockets in terms of plan designs and then access tends to increase from there throughout the year as patients meet those out-of-pocket requirements on other procedures. So I think we're still in the early innings, but we are seeing obviously encouraging signs on a provider-by-provider basis that we hope to expand as we make our way through 2026.

As it relates to the iStent franchise, so it's interesting. Obviously, implied when you go back and have done the work on the fourth quarter results, you'll probably see or have seen that we actually were back into the growth equation for our non iDose portion of our U.S. glaucoma business. And we talked about the trend heading this direction before. And so we were encouraged by the third quarter in that regard. But I think it's a little too early to call it a trend and really, it is a large part about, I think, the first part of how you asked the question, which is there's a lot of rep incentive and focus and company incentive and focus around interventional glaucoma and iDose in particular. And so we'll have to see a couple of more quarters to determine whether what we saw in the fourth quarter was a trend or an anomaly as it relates to that. And as a result, I think we've said for a little while now, it's safer to just assume that the iStent or broader non iDose franchise remains flat on a year-over-year basis when assessing our 2026 guidance.

Your next question comes from the line of Danielle Antalffy with UBS. Daniel, your line is open.

Sorry about that. I forgot how to use the mute button. Just a follow-up on some of the questions around iDose and stand-alone use. I'm just curious, if you look at the business as a whole, so iDose plus iStent infinite, what are you seeing there as far as the shift to stand-alone use? And at a higher level, maybe talk about some of the market development lift that's necessary to really build that market and what you're seeing? I know it's early days, but I was at [ AO ], and I felt like there was a big focus on this. So I'm just curious what you can say there.

Yes. Thanks, Danielle. I'm glad you [indiscernible] and you were able to witness that. And I think you'll continue to see more and more of that, whether it's at the upcoming [ AES ] meeting here later this week or ASCRS, a short while later. And I'll probably start in reverse that. It is a significant investment. We've been at this since the approval of iDose really in making that happen. It's not our first time going through transforming a marketplace. Obviously, we did it successfully over the course of the last decade for those patients that were faced with the disease in combination with cataract surgery.

And it really is a combination of incentive for your sales force alongside of the marketing efforts that we're making, the medical affairs efforts that we're making, the publications and the like. And when you put all that together and really build upon, I think, the enthusiasm that surgeons have out there for a disease that they know is interventional. Is the symptomatic and slowly progressing. And there's a really large patient population in need for a variety of reasons. It's about being on that journey on a consistent basis at industry conferences and all the moments in between that we engage with those surgeons and really changing the actual practice dynamics and shifting towards the stand-alone treatment of these patients and aligning both the behaviors at the practice level with the clinical belief that exists in the vast majority of the physicians that I'm sure you're speaking to or have spoken with in the past.

And when we put all that together, we continue to see substantial growth from stand-alone procedures, whether that be iDose or iStent infinite. And it's not a big surprise given everything I've mentioned as well as the fact that you have a market that's 20 billion eyes, 12 million of which are actively diagnosed and treated. And so you've probably heard us say and certainly, Tom say at other conferences and the like that over time, we expect that a number of glaucoma procedures done in the United States will exceed the number of cataract surgery patients that are treated. It will take time, but that's ultimately our focus and the reason why we're making such a substantial investment to the benefit of those patients.

Your next question comes from the line of Joanne Wuensch with Citibank.

I have some money in no order, are you seeing physicians creating a wait list for Epoxia? Would that imply a stronger second half once the J-code supply or put it into place versus the first half. Could you see 2027 [indiscernible] 2026? And if I do my math correctly, iDose guidance is $225 million for the year. What makes that the right number?

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

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

Okay. So I'll try to go through those in the word that you asked them. So from an Epioxa perspective, we are starting to see -- I'll give you an example. We certainly were seeing patients be enrolled in our hub for approval to Epioxa. So inherently in that means that a waitlist is being created. I don't know that it's enough to impact our first quarter. I think there'll still be enough of [ Photrexa ] there, as I said earlier, to drive year-over-year growth. But we do expect that weight listing dynamic, if you will, to be much more material in the second quarter to the detriment of that for the cornea business and probably the benefit of the latter part of the year.

Certainly, the fourth quarter perhaps in the tail end of the third quarter as those patients start to get approvals and access the therapy and ultimately treated. So we absolutely expect the second half to be the key contributor to those results. And as we learn more about that, we'll obviously dial in our expectations in a much more meaningful way.

As we think about 2207 versus 2026. Yes, I probably will stop short of giving at this [indiscernible] stage 2027 guidance implied by the comment. But clearly, you've heard from us that the combination to [ 12 ], if you will, continued acceleration with iDose alongside of what we hope will be a meaningful acceleration with Epioxa makes not just 2026 an attractive year. But 2027 and beyond as we look out and think about what it could do in terms of driving our business and the top line associated with it. I think your last comment was the implied and we didn't give the exact number. But as you get into the numbers, I think there'll be a range of estimates that come in, in that general ZIP code and what makes it the right number.

Look, we're always looking at a bell curve of scenarios, the various puts and takes within these and trying to establish guidance both on a macro level as well as on a more micro level that we think is achievable for us. And in this case, as I've said previously, I think we've got multiple pathways to both grow and continue to grow sequentially as well as achieve that. And as we make our way through the year, we'll continue obviously to update those views and provide them as we go forward here.

Your next question comes from the line of [ Steve Lichtman ] with William Blair.

A question on iDose. And you gave us a sense of how many surgeons you trained last year and to date or even qualitatively, can you talk about where you are in that process still early to [indiscernible] innings? Any color on that would be helpful.

Yes, Steve. Welcome to William Blair. And I think from a surgeon train perspective, it's not really been a focus for us in terms of what we communicated Street, and that's my intention that, that's really not the, I'll call it, gating or limiting item for us. Our surgeon training activities have been as strong as they've ever been. The vast, vast majority of the surgeons have already been angle trained over the course of the last 10 years of utilizing MIGS technologies. So from a sustained pharmaceutical standpoint, we're good there.

And it's really not been, I'll call it, the step function that's driving where we're at. I think broader office administrative related considerations, reimbursement confidence, professional fee. And then as we move forward here, bringing commercial Medicare Advantage online are much more key drivers to where we're at and where we're going. But so far, we've been extremely pleased with the pace and the overall ability for our sales force to train these doctors and the OR and get them comfortable with the iDose procedure.

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

Yes. And I think it is a balance, and we'll see how it plays out in the court of 2026. You have competitive insurance, in particular, in some of our larger markets. In 2025, it did go a little bit more slowly than maybe we anticipated or certainly built into our forecast. And that's the credit to our teams that operate in those markets and the relationships they've built and I think the differentiated positioning of our technologies.

As we move forward, we do expect those efforts to continue to accelerate. But to your point, they're also balanced against our launch and launching of iStent infinite throughout the European region, some of the affiliated markets that follow European approvals or clearances as well as continued sort of blocking and tackling that we have around opening up markets or markets within markets and that journey never stopped.

So I think as we make our way through here, it will be that interplay, you're right. And coming off of constant currency growth in the fourth quarter of 13%, and as you heard me say earlier, we expect sort of high single digit to low double digit in the first part of the year, ultimately abating to something a little bit slower in the second half to be in the high single-digit range for the year. I think, is a good place for us to start off the year as it relates to our guidance for that part of our business.

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

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

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

Okay. Thanks, everyone, for joining us today. My name is Allen Gong here on the medical supplies and devices team at JPMorgan. Really glad to be introducing the management team at Glaukos today. We're going to start off with some prepared remarks from CEO, John Burns, and then we'll tag in Alex and Joe for some Q&A afterwards.

Okay. Thanks, Al. Well, good afternoon, and thank you, everyone, for coming today. I do want to formally introduce Joe Gilliam, who's our President and Chief Operating Officer; Alex Thurman, who's our Chief Financial Officer; and we have Chris Lewis in the back, who's our VP of Investor Relations. So I'm happy and delighted to give you an update on the progress we're making in the business. Begin talking about what we're about. Innovation is at the core of everything we do in the company. I think that innovation has propelled us into a company that's been the maker of new markets in ophthalmology. If you think back and look at our history, we pioneered, created, developed and now lead the entire global MIGS marketplace. We are currently creating an entire new marketplace with procedural pharmaceuticals led by our spearhead product, iDose. We've entered the rare disease marketplace, and we currently are captivating and moving forward a whole new marketplace on corneal cross-linking, a new procedure to arrest the progression of keratoconus. We're beginning a nascent approach to using transdermal creams that will incorporate APIs to be able to treat anterior segment disease, is something that's never been done. And then finally, we have the temerity to believe we're going to build a retinal company as well. And what we've done there is to look at TKIs, small molecules, which will be wrapped in a PLA PLGA matrix that could deliver months of therapy versus current modalities today. When you think about it, our whole conception and movement has been towards dropless therapies. So topical drops have been the mainstay of anterior segment treatment within ophthalmology. And yet, I think increasingly that form of therapy is viewed as an aconistricnistic. It is inefficient. There are far better ways to approach this. And so we began several years ago to create a hybrid organization trying to draw the best of medical device and pharmaceutical together, which you know is extremely difficult. And by doing so, we've created combinatorial products that we think are going to be able to not only create new marketplaces but give us sustainable competitive advantage for many years to come. We're focused on platforms. So platforms that will chase big ideas and unmet clinical needs, and you may have seen this to before. The circle, we talk about iStent, which throws off a cascade of subsequent products, iStent iStent and Jack stent inject, iStent infinite, iDose is already thrown off iDose TREX and iDose Trio, which we'll talk about in the course of the presentation. i Link, we had POTRExa. We're introducing Epiox into the marketplace, and there'll be a third-generation sphere, which will be available in short order during the planning period. [ Dilution ] is our nascent approach looking at transdermal drug delivery, which will be led by approaches to Demodex mites and the treatment of progressive myopia and then finally, retina. The important thing here is the $800 million or so we spent in the company in R&D since 2018 has yielded a tremendous font of new products, 12 that are commercially available in 13 that we've disclosed that are in various phases of development in clinical and regulatory approval.

Just this past year, we hit over 30% market growth. It's a record quarter that we just hit, which we'll talk about. And over the course of the 10 years, we've sustained over 20% CAGR every year. Our main and obsessive focus this next year and really for the next couple of years to come is going to be in 2 areas changing the paradigm of treatment within glaucoma and changing the paradigm treatment within keratoconus.

Let's focus on glaucoma first. The current paradigm of therapy in glaucoma is broken. I think that's been starting to be acknowledged by the clinicians in the United States. Surgeons typically will start with topical drops when those fail. They go to progressive serial use of multiple medications and give ground and lose vision before they turn to more draconian late-stage procedures. This is kind of a [ Sisayan ] approach to the treatment that we want to be able to reorder and change. If you think about it, medications work pretty well in clinical trials, but they don't work very well if patients don't take them. And so when we look at the data, 90% of patients in multiple clinical studies have shown to be nonadherent to their glaucoma medication regimen. 50% of these patients won't even fill a script after it's been drawn after 6 months. So there has to be a better way. What we want to do is to have clinicians and surgeons across the Rubicon, start to look at interventional approaches that provide 24/7 treatment for disease in order to arrest the progression of glaucoma and that can be done either through SLT or through our procedural pharmaceuticals. And then we have a cascade as we move forward with MIGS minimally invasive [ bleb ] surgery and ultimately filtration surgery, which is late-stage trabeculectomy and aqueous shunts. The key here is to treat patients better. to our rest progressive vision loss and to put power back into the hands of the clinician where it should be. So we've got a workhorse in order to move the market forward, and that's been [ the dose has under ] a 505(b) designation that we had from the FDA has the ability to be used all the way from ocular hypertension all the way through refractive glaucoma, refractory glaucoma. So -- you think about it, there can't be a more substantially open label than what we have with the iDose TR. And when you look at the surveys that are being done and how well this product working, it's being validated. Everything we see in the field is that people are seeing demonstrable reductions in intraocular pressure that are sustained in a very, very benign and safe procedure. Anchoring the back end of this approach is going to be our stents, our prosthetics, both the iStent infinite, which is indicated for patients who failed on medical and surgical therapy. And of course, the iStent [ inject W, ] which is used in combination care procedures. We'll talk about iStent infinite. We've just completed an open angle clinical study where we will be pursuing and expansion of the clean for iStent infinite into mild to moderate open-angle glaucoma, and we expect to have this product available we're targeting for the end of 2027.

Let's focus on iDose TR then. Again, it's important to reflect on the data. In the Phase III clinical trial, even though 23% of patients were on 2 or more medications to begin with, 81% of patients who had iDose were off of all medications at 1 year. At 3 years, 70% of patients were well controlled with an iDose implantation on the same or fewer medications. And new data now showing at 3 years, the iDose device is noninferior to timolol even though we know in clinical trials, the patients will take the prescribed medications far more often, they will in the real world. And so -- this is exciting new data and you can't really see it from the slide here, but you get an idea of just looking at that circle on the finger, how [ Goshorn, ] small this device is. It's de minimis and yet it holds enough power to be able to deliver the prostaglann analog and really for comparable 2,200 eye drops over that 3-year period. So this has been a substantial revolution in the treatment of glaucoma.

So we're doubling down. Shame on us if we don't take the herculean effort we've had to bring this product to marketplace and figure out how do we make this thing do more and be more over the course of the next several years. And we already have 2 different products that we've disclosed, the iDose Trio, which is an applicator, which should be able to drive in-office use of the iDose device, which has been an important intentional plan of ours for very, very many years. It should be able to deliver a product through 1-millimeter incision, which is really the magic bullet for a cell sealing incision where you can maintain intraocular pressure, you don't get the essence of aqueous [ humor ] that will come out the hole, and it should allow surgeons to have far more confidence in doing this in office. It will facilitate the movement there. We've already begun a Phase III clinical trial for this product. And in human factor studies where even we compare this with our own iDose applicator device, 90% of patients are of clinicians preferred this new applicator over the current applicator that we have.

iDose TREX is a cool next-generation product, which we already have in a Phase IIb/III clinical trial. And just by bowing out the radius of the device, we're able to incorporate over twice the amount of medication micrograms or approximately twice the amount that's in the iDose device. And so by the new math, because we're not seeing any decay of that product inside the device over the course of when it's incorporated in the eye, we expect this product could go a target of 6 years with a single injection. We are already off and running with this Phase IIb/III clinical trial. And when we pulled a subset of patients in Phase IIa, you see the data. We're seeing 8.6 to 11-millimeter reductions in pressure. This is outstanding data by any measure. We're hopeful that it continues in the future and moves forward. These 2 different approaches are just 2 of you'll see there, 6 plus. So we already have another 4 form factors that are under active development. So my goal here, if we're going to build this procedural market, no one is going to take it away from us, and we're going to be able to build this move this into the 2030s with a substantial cascade of new products that either incorporated different facets of the prostaglanin analog or use entirely new APIs to be able to treat disease. Okay? So those are all undergoing.

When we look at the actual procedure itself, it's really cool. This is the new applicator that incorporates. You see it protects the sleep protects the device as it goes in surgeon all he has to do is to push this through the trabecular meshwork into the sclera and tap it to make sure that it's secure and in place. And those 2 arms that extend that have put that product in will become the basis for when you want to remove that product in the future and place a subsequent product [ 100 ] hour over. So all well through, well thought through and well advanced in clinical trials. Camfragan iStent Infinite, iStent infinite in the clinical trials. Over 3/4 of patients had 20% or greater reductions from preoperative means. 50% of the patients had 30% or greater. And so the product works, that works spectacularly well because it spans a greater distance of the trabecular meshwork to be able to access episclerovenous system and to be able to provide bonifoutflow. Importantly, we did an integrity study, we compared the iStent infinite versus a very prominent competitor in this space, and we found that in that study, the iStent infinite demonstrated superior safety and efficacy. We published the 6-month data. We're going to be publishing the year data shortly.

This is what's going to drive this whole new marketplace. And when I look at interventional glaucoma in the practice, not only do we have the means to get surgeons and patients there with high-quality new products, but look at the size of this marketplace. 22 million eyes and prevalence and 12 million today that are diagnosed and treated. And when you think about over on the left side of the slide here, there are 5 million cataract procedures that are done every year. This is the bread and butter of ophthalmic surgeons practices. They focus all -- most of their time and effort on acquiring and doing these cataract surgery patients. And yet cataract surgery is a one-and-done procedure. It is a catch-and-release procedure. You do the eye the patient is gone and leaves. Here, what we're trying to convince surgeons and we will over time is that each 1 of these patients of these 12 million eyes has a statutory term from time of diagnosis to time of death of about 20 years.

And so you have the opportunity to do multiple entries with every one of these eyes over the course of the -- the patient's lifetime. And in doing so, not only doing the best clinical practice to arrest the progression of glaucoma. But can you imagine the effect that this will have on the surgeons' practices. They're just waking up to this, and we are the ones that are shaking them loose and are going to make this happen as we move forward. One of the important things that I want to be able to tell you today is that not only do we have the ability to place this device to last for 3 years. But more recently, we've had some very constructive dialogue with the FDA. So anyone who's been following this company knows that I've been quite sober and cautious about any pronouncements for our PDUFA date that is coming forward at the end of January for readministration. And what I will just tell you is that I'm very encouraged by some of the dialogue that we've had with the FDA that by no means is this a done deal. But I will tell you that we're in a far better place than we were just several weeks ago.

So what's the vision for the next 10 years? Well, first, for the reason that I said and one of the things I didn't mention is when I started to promote intraocular lenses in this business, surgeons were getting over $2,000 for every case. Today, they're getting $465. And every year, it decreases. It's a [ meltinicecremcone. ] So surgeons are going to look for, actively look for different ways to be able to develop and sustain their practices and IG therapy and the implantation of these devices is going to be a core reason for them to turn to. I think combination therapy has the potential to become a preferred form of therapy -- right now, with topical therapy, 50% of the marketplace are on 2 or more medications. Doesn't it make sense if I'm entering the eye that I would put in an iDose and put in a prosthetic next to it like an iStent infinite which both have different mechanisms of action to be able to reduce intraocular pressure. It's going to happen. And we're going to lead it. We're doing now Phase IV clinical studies to show the additive effect of using iStent infinite in combination with iDose versus iStent infinite alone.

In office injectable therapy of iDose and repeat administration approval, either in the form of a successful PDUFA date or in the form of us bringing forth TREX, which is going to become the de facto next opportunity for surgeons who've used iDose will drive adoption and continue to expand this marketplace and new sustained release drugs like TREX, you can imagine anyone sitting in the audience here if you're diagnosed with glaucoma and you're told you can either use a medication today, you're going to need multiple medications over the course of your life. They have multiple systemic and local side effects or I could just while you down the hall where I do my LASIK procedures, put a little numbing agent on your eye and inject this tiny implant in cure that could last for 6 years and put a bullet in glaucoma. I know where my vote would be.

And PE groups, which are taking a more extraordinary view and dominance of the landscape are already seeing the value of employing this kind of mechanism, both for our clinical value and for practice efficiency value in their practices. And finally, what I view is in the future, if we're successful moving this forward, we will create a new cadre of IG surgeons. These are people who will say, I do my cataract procedures on Monday and Wednesday. On Tuesdays and Thursdays, all I do is inject iDose, iStent infinite and some other competitive MIGS products. I have my ODs do all the workups they send me these patients, and I do a prescriptive form of treatment for them. It's going to happen. It's already happened on the retinal side where surgeons are doing injections, multiple injections over the course of every day. My hope here is we create a new breed of IG surgeon and maybe create a little carpal tunnel syndrome, the fact that they'll be injecting so rapidly and so often.

If I'm right, by 2035, the U.S. ophthalmologists could be performing as many interventional glaucoma procedures as cataract procedures. Today, 5 million cataract procedures, less than 1 million IG procedures. So 2 years ago, this was -- this would have been an absurd statement. Today, it's just merely highly controversial. 5 to 7 years from now, I think this will be self-evident, and we will drive forward to make this happen. So stay tuned.

And when you look at the full product portfolio we have, you can't help but be encouraged that we've met our initial mission, which was to create a portfolio of products that gave patients the best benefit to risk ratio at every stage of glaucoma for ocular hypertension all the way through refractory disease.

So let's turn now to Interventional keratoconus. Interventional keratoconus is this thinning of the central cornea that happens in really kids, teenagers and young adults. It's a very devastating disease. It's a disease that if left untreated causes blindness, 20% of patients today that have keratoconus will have to undergo a corneal transplant during the course of their life. This is a rare disease that we are absolutely intentionally going to be obsessive about treating -- and why? Why? Because newly diagnosed keratoconus patients today don't get treatment, less than 1 in 5 patients who are diagnosed with keratoconus get treatment even though it is a site of a resting and blinding disease. There's a number of reasons for that poor awareness levels. It's hard to diagnose. A lot of times an OD we'll see a patient, they'll see their topography and They'll diagnose a regular stigmatism or some other corneal anomaly and not keratoconus. And even more so, what they tend to do is to treat with lenses, so either RGP or scleral lenses they'll treat the visual dysfunction, but they don't treat the underlying morphology of the disease. And frankly, the Epi of procedure that we had previously does cause pain. And so patients are wary of having that procedure done. And certainly, we've seen that in the patients who've had the procedure done avoiding the second eye. If you look at the data on the left-hand side, it's just telling how much work and opportunity we have to do in this area. 13% of patients are diagnosed before the age of 18, where most of those patients already have progressive care diconis by that age. And until they're treated, 70% of patients are already at Stage 2 keratoconus with significant loss of vision. Interestingly, this is a disease of kids and the average age of treatment today is 32 or 36 years old, depending upon what study that we've looked at. So we mean to make a difference. We're going to do so by introducing Epioxa. Epioxa is an oxygen of fuse new proprietary product, which has a surfactant in it, which helps it drive through the corneal epitheium into the stroma where it needs to work. And what an opportunity to take a topical drug where else in medicine do we have the installation or the use of one topical medication or an oral agent that completely are a site-threatening blinding disease. And this is what we have here with Epioxa. We've seen the clinical data. It met its burden with the FDA. We're seeing some good reductions in K-MAX, the peak of the cornea. And we think that patients will be far more willing and surgeons, but farmer willing to do this procedure on more patients. There's a number of things we need to attack to be able to get their sites of care, engaging OD networks, et cetera. This takes a tremendous amount of currency and effort to do so. So when we looked at some of our colleagues in rare disease, we started to understand why they charge hundreds of thousands of dollars for treatment. This is going to take a massive capital on a massive effort, but we are committed to do this and to create this marketplace and to increase substantially patient access. We're going to go through the normal blocking and tackling of launching a new product to put us in a position when we get a J code and target date of July and moving up next year to really start to move this marketplace in the second half of the year. And I think I'm most excited about the next generation. I was around early with the advent and progression of LASIK where we took an exome laser and we took Cornatopography and Avarometry, and we could actually program and be able to shape the lens to be able to create the best corrected visual acuity. Why the head count we do that with keratoconus. So we already have instituted a place where you take a picture of the eye, you look for the peaks, the valleys, the mountains, those then will go into a customized algorithm for every patient as we move forward. We've already taken this through Phase II data. We very much like what we see, and it's prime for moving into Phase III in short order.

And finally, we plan on owning this marketplace or from building this marketplace from top to bottom. And so we are beginning the clinical trial with a product and company called [indiscernible] even that we acquired, which is a copper sulfate drug. And the goal here, we think that many patients who have nascent or very early stage keratoconus well the opportunity to treat with topical drops prior to doing a more standard therapy.

So as I start to close, we look at the area that we're also focused in on a spearhead and moving into transdermal treatment of APIs. And the first area that we're focused in on is the treatment of Demodex mites. [ Tarsus ] has done a great job building this marketplace. This is one opportunity where we go second. We don't go first, but we think we have an opportunity. If we can take a potent [ acetycholinesterase ] inhibitor, and put it into a cream and put it right on top of the critters. These parasites that are forming and causing inflammation blepharitis, we think they have the opportunity to have a breakthrough product within Demodex Mike's treatment. It's a huge marketplace, 400 million, 25 million patients, and we've already begun a clinical trial in this effort.

And finally, we look at our biodegradable implants. For those of you who have been following us for some time, we look at what we've done in a persistent rental vessel leakage model with the implant of this TKI axitinib in the special formulation that we have, we're able to see now over 3 years of efficacy, which gives us tremendous promise moving into clinical trials. And just to let everyone know, we have just finished our Phase IIa first-in-human clinical trial of axitinib and expect data later this year. You can't help but look at the total portfolio and put this up against anybody within ophthalmology. What I tell my people and my company is that if I stopped innovating today, we'd have enough commercial products to take us through potentially the mid-2030s into the late 2030s, and we're not stopping. We continue to invest, we continue to move forward.

Finally, on operational side, I love putting this slide up. We just had a record quarter. We hit $507 million over the course of 2025. When I look at what the initial guidance or consensus was in 2026, we're looking at a 20-plus percent CAGR over 10 years. We continue to have the highest value gross margin profile of 84%, a high and healthy balance sheet of $283, and we diversified our company for growth and to a lay risk by moving into international markets. We're now in 17 vertically integrated operations across the globe and over 300 different employees.

Finally, we've not only created this new state-of-the-art manufacturing site in San Clemente for the treatment of -- or for the production of iDose, but now we have broken ground in Huntsville, Alabama, and we'll be moving forward there with a very, very substantial facility, which will give us the ability to not only have belt and suspenders with our current products but be able to manufacture some other products, proprietary products that we have both disclosed and undisclosed -- so we have this mantra we'll go first. And to me, it's not a statement of aspiration. It's a statement of fact, and it continues to guide everything we do, both now and in the future. So I thank you. And with that, we'll open it up to questions.

Thanks for that. So I guess, just to kick off the Q&A. I think what's top of mind for a lot of investors is the quarter that you just preannounced. So you ended the year a healthy step above expectations. You had nice sequential growth for your [ AtreXabusiness, ] which I think was a bit of a surprise. So I guess let's just start there, right? I think you had previously expected that -- as you move towards Epioxa, you would see the [ Petrex ] business naturally wind down, you're planning to discontinue that product once you have Epioxa out yourselves. So I guess what drove a sequential actual acceleration in [ Photrexa ] growth contrary to your expectations? .

Yes. Good to see. I think from that standpoint, you'll recall what we said was we wanted to be cautious about that dynamic because, quite frankly, we didn't know coming into the quarter exactly how physicians would react. Obviously, the approval of Epioxa, when would they start having that conversation with their patients. And clearly, once they start having that conversation, many patients are going to want to wait for the availability of the therapy for all the reasons that Tom said. So as the quarter played out, what we saw was that physicians really continued on as usual. So from that standpoint, they continue to treat based on their schedules and what we're there. And I think more of the engagement around the Epioxa conversation, we've seen start to happen as we've turned the clock into the new year. And there's a variety of indicators that we've got around that. But in general, I think the fourth quarter continued as it was. And I think there's a handful of customers who maybe have a little bit longer time horizon to adoption of Epioxa where they may have also purchased a little bit of [ Trex ] there towards the end of the year, but not something that's material enough that I'd call it as a major driver. It was pretty much another normal quarter for us on that business.

Got it. And I think just the decision to scale down Photrexa really go all in an Epioxa. I know when [ Avedro ] was a stand-alone company, they were talking about it being a portfolio approach, right, kind of [ Epi and Epion]. So why is going all on an Epixo the right choice for you?

Yes. I mean there's a variety of drivers there. And depending upon who you speak to on the clinical side, there are those physicians who feel very strongly that with availability of Epioxa, you really shouldn't be doing the Epi-Off procedure. And there's also many pathways to ultimately treating Epi-Off as a procedure utilizing [ Epioxasapharm -- ] so it doesn't necessarily mean that there's a restriction of how physicians will actually practice medicine. At the same time, you have to overlay market access-related considerations and making sure that patients at the they are getting access to what we believe is a superior therapy here. So when you put those things together, it was -- it's hard to have a path where you can have that full portfolio, if you will, of both [indiscernible] and Epioxa available in the bag. But again, it doesn't -- does not necessarily mean that you're taking away options for the physicians to do the procedure of choice if they choose to do epi off or Epion even though we believe the vast, vast majority will do at beyond.

And you laid out a very clear time line for your strategy for getting Epioxa through reimbursement, through coverage to commercialization. But I guess just help us understand the most recent comparison that I think a lot of people are going to reach for is the trajectory you had with iDose. But from my understanding, Epioxa, especially because you're targeting a younger patient population, you're going to -- it's going to be a little bit different in terms of getting reimbursement, getting -- so can you just walk us through the differences there, the challenges or the advantages of the keratoconus products?

Yes. And I think the start, the fundamental premise that you should use iDose as a comparator is probably should be set aside. It is truly apples and oranges. And the primary reason for that is you sort of alluded to, with iDose, you're focused, especially at the launch, as you know, and how we approached it. with the Medicare fee-for-service world. So so much of that was driven based on the MAC activities and getting the sort of certainty of coverage and payment there that we expected to get, and we still are in a couple of the MAC, very different than, I'll call it, the hand-to-hand combat, if you will, an associated with dealing with a broad array of commercial payers. As you know, there's over 100 major carriers 500 sub plans and over 5,000 plans within that. And so that process is much more of a day-to-day process of making sure that you're getting prior authorizations that you're getting peer-to-peer conversations that you're really manually driving the change of their standard. Now you support that in a variety of ways. Obviously, our payer relations team have been all over this since the day that we got the approval and the education process and the things that are there. But ultimately, this comes down to those conversations, combined with physician conversations plan by plan, medical director by medical director, where you get enough through there where they understand that the standard of care has shifted in now epioxa and they start to streamline that access. And that's a process that some payers will play out relatively quickly. And with others, they take a much longer process. And some of that is by design, and some of that's by [ happenstance, ] but all you can continue to do is keep pushing forward on every single 1 of them using a combination of those physicians, patients and overall advocacy efforts, if you will, to make sure that you're getting that coverage. .

I fully understand, you've pointed to the other drug kind of predicates for your pricing. But when [ Petrex ] was being priced people were worried that 3,000, 4,000 would be too much for that procedure. You've kind of taken a step function higher. And while, again, we have the predicates to kind of use as a comparator, are you concerned about sticker shock in your conversations with commercial payers? Is that something that you're seeing or that you anticipate seeing? And how do you kind of work through that? .

Well, I think the here and now, you are with the macro. Yes, we'll talk about the initial pricing that occurred with FETREXA was done with the early Avedro launch and it really was for refractive conditions -- it was to be able to treat low-level myopia. And so because of that, they had to price the product so that a retail level, a surgeon could get and charge $1,500, $1,600 to the patient and the company itself would charge $500. When [ Ressano ] came in and they moved it to a J code. They moved to $2,850, and they thought that was a big jump. I think our findings have been that at this price, you cannot be able to compete and to build a rare disease product and everything that we viewed from the work of [ TEPEZZA, Oxybate ] and others shows that an extraordinary amount of capital to be able to find, identify, recruit and bring these patients to the table. And that's the reason we made that. Now Joe will get to the payers, but I can tell you, with our customers, sticker shock occurred initially, but we spent an ordinate time teaching them and bringing them through why we're doing what we're doing and why we're trying to create additional patient access an area that we haven't been fundamentally successful moving forward today. We're treating about 10,000 patients with epioxa similar to an [ oxybate and TEPEZZA. ] There are far more many patients. So what we hope to over time is to disprove the notion that this is a rare die we're successful enough and provide patient access, we may be able to get there.

And I'd just add, I think we've -- we're ahead of schedule in the way I think about it. I think we think about it in the context of whether it's those initial conversations with physician customers that are there. Whether it's the side of care network and getting that established for Epioxa or as you ask the question from a payer perspective, I think it's important to take a step back sometimes and realize that ophthalmology, while it's everything to us is about 1% of health care spend. And when you take a subset of that, it's easy to understand why for the vast, vast majority of these payers, it's in an unmanaged category. And so when it's an unmanaged relatively low cost in the aggregate because of the in is so small in those patients, they tend to defer to what is accepted medical practice. And so that's why I say it's so important that what they really want to hear is that physicians say, I obviously want to treat this patient who has a sight-threatening disease with a therapy that doesn't require the debridement of the cornea in weeks, if not months of recovery time. It seems obvious to all of us in the room, but they want to hear that directly from the provider. And so we do the seating of that. We have those conversations. We have our medical affairs and all the various people that do those exercises. And then ultimately, they need to hear that from the physicians or the patients themselves and go through that process. But I feel we're confident based upon the conversations we've had today and the feedback that we've been receiving that this is a manageable process, and it's not a matter of if they're going to cover Epioxa. It's just a matter of the normal processes and time associated with it. And again, as I said earlier, some will move more quickly. we'll get earlier access and some will take a little bit longer because of their time lines and when they update policies and dips and things like that. But we're well down that path.

Okay. I really wasn't expecting iDose to kind of be playing second fiddle to something this early, but I do want to talk about iDose. We put up $45 million in the quarter, which good sequential growth, but optically, it looks like it decelerated a little bit from the pace that you had from first quarter to second quarter to the third quarter. So help me understand the dynamics that drove that and how we should think about the ramp through 2026 and the right exit rate to be using?

Yes. First of all, I don't think there's anything fundamental different about what's going on in the health of the adoption, both in terms of new customers as well as what's going on there. It was another solid quarter of progress just from a macro statement. It doesn't have any impact on how we're thinking about the, I'll call it, the transition into 2026 and our expectations for what iDose can and can't achieve in that context. I think there was a couple of isolated things and especially a little higher price points, small ends, move numbers in a more material way. In this case, I think 2 things I would call out. The seasonality factor associated with Medicare fee-for-service isn't the same as Medicare Advantage. So sometimes we think about it and even collectively us, the seasonality of the fourth quarter. And what we found in this quarter was a little bit that, that actually can work against because what the practices do is they index towards Medicare Advantage. They had to get all those patients in before the change in the year, which means they under-index a little bit on the Medicare fee-for-service. So just in terms of the share, if you will, of procedures being done, it was a little less indexed towards our sweet spot, and that has a little bit of an impact there.

I think candidly, the other thing that we saw analytically is that whenever you're in a launch, you have short dated, call it, compensation plans and different things driving your -- the incentives of your sales force. And the reality is we expected a little bit more of a softer third quarter because of normal summer it didn't materialize that way. And I think as a result, we could see that there was a little bit of pull forward into the third quarter from obviously, the fourth in the context of individual rep behaviors. That's very hard to control. Everybody goes through that. Normally, you have a balancing even quarter where some pull forward some push out. In this case, we saw a net pull forward. It was a little unusual. And so I would actually argue that probably the reality is that the third quarter should have been a little bit lower than what was being reported, fourth quarter a little bit higher. And quite frankly, the trends in terms of the fundamentals that we see, there's really just nothing that's changed in the course of the trajectory we're on and moving through that.

Got it. So if I were to say when we look forward to 2026, that fourth quarter is the right base to maybe work off of third quarter was a little bit stronger. But when we think about sequential improvement over the course of next year. I think the Street is at around like $45 million in first quarter. You don't need to comment on that number. But is that reasonable to think that sequential improvement as you continue to make progress with other [ MAX as NGS ] turns on an unreasonable way to think about it.

Yes. The way I'm saying is I think that if you were looking at it from a completely clean pro forma trended analysis, the fourth quarter probably would have been a little higher than the 45 that was actually reported out. And so when you think about annualizing that, you're on a $180 million to $190-ish type million run rate exiting the year. And I certainly think that we feel good about what that means. I mean when you think about 2026 obviously, you've got to continue just normal blocking and tackling every day new surgeons are being added and procedures are there. You haven't yet really seen the, I'll call it, the turn on effect of NGS, given the timing of that prophy establishment. Most of those procedures start to turn on in the first half of this year. It's not really a fourth quarter dynamic. Although we saw growth there, usually, there's a little bit of a lag. You've got the remainder of the MAX that obviously still need to establish formal [ prophy schedules. ] And I think importantly, we're also starting to lean a lot more into that broader I'll call it portfolio of commercial Medicare Advantage lives that now enough has been out there where I think we think it's time for our customers to start being able to lean into that. We can support that and so that's a key driver for 2026. I think there's plenty of different avenues in which we achieve some of the numbers that we've seen out there amongst the very Street models, and we feel confident about the path iDose is on.

Got it. We have less than a minute left, but Alex, just really quickly. the gross margin side of things, especially with Epioxa coming in now, I think you can get really, really bullish on the gross margin. You clearly have a lot of opportunities to continue to invest into you have to support the Fix the franchise as well. But how should we think about leverage in 2026 and beyond? .

Yes. You absolutely should think, and we plan for continued leverage in the model over the course of 2026, given the factors that you just said. And a lot of investors will ask about the path to profitability. And I'll reiterate, we do believe the 3 of us that these 2 products will lead us down that path in the midterm, and we can kind of see a clear sight getting there. But in the near term, I'll reiterate kind of what I've said over the past year, which is our near-term goal is to continue to live within our means to balance our revenue generations against the expenses and the investments we need to make. And shoot for cash flow breakeven, plus then next step would be cash flow generation because we do have a lot of investments in the Epioxa launch that Tom and Joe have described as well as the pipeline programs that Tom described, 13 out there. a lot of great things coming. And so we continue to reinvest in the business in the short term.

Perfect. Thank you all so much.

Thanks, Allen. Thank you.

[Audio Gap] Global Healthcare Conference with the management of Glaukos, and welcome.

Thanks for having us.

I have extremely clear memories of sitting at this podium a year ago, and you were just starting to launch iDose. And I will have iDose questions, but I also have other questions about other things like Epioxa that were not even on the horizon a year ago.

For you or for investors in general?

For Investors...

Yes, yes.

All right. So I want to just do my favorite step back, sort of take attendance. Where is Glaukos today? How do you think about the company? And how is it different, maybe not versus last year but maybe versus 3 years ago?

Yes. I mean I think what you're starting to see is the emergence of something that we've been hard at work at for a really long time. And obviously, pipelines and products don't emerge overnight. And so it's a part of Tom and the strategy from 10-plus years ago to be creating what we think are differentiated product solutions in large market opportunities and taking differentiated bets on how to tackle diseases based upon the needs of the patients and the physicians more than say core competencies of the organization going in the past, right?

To your point, we started as a microtechnology manufacturer of stents and everything associated with that to develop the MIGS category in medical devices. And here we are today on the precipice of doing more pharmaceutical revenue than we do device revenue. And certainly, from a pipeline perspective, when you look at the breadth of that, there's an awful lot of sustained release pharmaceuticals, procedural pharmaceuticals of hybrid products that are around that.

And so we've been quietly and methodically at work putting together the puzzle pieces of the infrastructure to make that happen, both in terms of development talent and now commercial talent. And you referenced, obviously, Epioxa, and that's been something we've been hard at work at for 3 years to have the right people in place to truly manage the launch of a rare disease category that is so different than anything else that we've done historically or that, quite frankly, most traditional pharmaceutical companies even really try to tackle.

And so we're pretty proud of kind of sitting here today in what we've got in front of us. And I think we're just now at the beginning of unlocking some really meaningful opportunities for the company. And we're happy that there's investor enthusiasm for that, but there's just so much opportunity that we're mostly focused on just continuing to put one foot in front of the other and making it happen.

So I want to start digging in just a wee bit on the core MIGS market. And this market has grown double digits this past year. It's on track to decline single digits. I think your commentary was for mid-single digits next year. I might be making that up. But I'd like your view of sort of a state of the union now that we're a year after the LCD impacts.

Yes. I think you're -- so this is a good building block question, I think, in the context of the legacy stent and MIGS franchise and really not talking about iDose at this point, but you're mostly focused in there around combination cataract MIGS. And clearly, this is not the exact number, but if there were about 250,000 devices being deployed in 200,000 procedures prior to the LCD, you saw the extra 50,000 largely be taken out of the market, and that was the impact that you mentioned.

And if you look at our own results, we really saw the peak of that in the second quarter from a year-over-year comp standpoint. The third quarter was obviously some progression there. And if you unpack our -- even our guidance for the fourth quarter, it shows continued sort of heading in the right direction on sort of, I'll call it, stabilizing.

As we think about next year on that side of the franchise, if we didn't have iDose, I'd be pretty bullish around what kind of growth we'd be seeing out of the stent business simply because we'd be driving in that larger pool of patients in stand-alone care. You're no longer just constrained to my prior point, 250,000 or 200,000 potential procedures, you're now going after much larger.

But it's hard to have addressed that without also thinking about iDose. And the fact that when we approach any customer of the conversation, we're leading and finishing with the iDose part of the conversation much more than obviously the stents, as you can imagine. And so where we've kind of landed, I think, with the investment community is, let's assume that the situation has stabilized.

And I think it's a safe place going into next year assuming that the business is more of a flattish-type approach from a results standpoint on a year-over-year basis. And then we'll see how that plays out, plus or minus that over the course of the year. But I think relative to the other growth drivers that you're going to spend more time on from iDose and Epioxa, it's a safer place just to kind of assume that the stent business is flattish next year.

So flattish next year. And I'm just -- you're right, I am using this as a building block question. You've heard my questions before. But you said if you didn't have iDose, is that because of patient Mr. Smith would previously have gotten an iStent infinite, but today is getting an iDose? Or is that more a reflection of Dr. Jones who normally would use their time for an iStent infinite is now using their time for an iDose?

Yes. It's a little bit of a combination of the available technologies, as you say it. So today, if you have a stand-alone or even a combination cataract patient, if they can qualify from a market access standpoint or reimbursement standpoint for iDose, many physicians are going to lean that direction because when you look at the clinical profile, the outcomes, the safety as well as the duration and just that even the responder rate associated with it, it's a great place to start.

It's foundational, right? If you didn't have iDose as an option, then in that case, iStent infinite provides a great tool for going after that. And if you overlay on top of that, I'll call it our own sales force and marketing efforts, just the sheer amount of dollars, capital and airtime we're deploying towards iDose relatively speaking, if that was to go away, your entire effort and focus would be on iStent infinite and unlocking that same stand-alone opportunity just with a different tool.

So I think it would be on its own growing quite nicely. But today, we're cannibalizing that with iDose, and I think that's what you all as the investment community would want.

And when you think about reimbursement for concomitant MIGS, it looks like it's down low double digits for 2026. Am I reading the details of the reimbursement codes correctly? And does that matter? Or how does it matter at this stage?

Yes. So you're talking about the professional fee. So on the facility, the economics are still up again this year modestly. On the professional fee side, you are looking at low double-digit decreases. Now that is consistent with nearly all of the ophthalmic codes. And as you know, better than most, also consistent with many of the other subspecialty codes that are beyond ophthalmology.

So it appears to us that CMS is a part of the rule-making cycle on the professional fee side, prioritized certain disciplines and certain procedures in the hospital setting and things like that at the expense of what they perceive to be a more efficient care paradigm in specialty groups and ophthalmology is one of those. And so you saw that hit really across the board and combination cataract MIGS are certainly one of them.

And before I leave or we leave MIGS, are you seeing more stand-alone MIGS being done? And I'm talking traditional MIGS, I'm not talking the iDose family yet.

I think all technologies benefit. My guess is that -- and what we see, obviously, iDose is first and foremost for us. Clearly, we see more stenting going on, whether it's in combination with iDose or on its own from a stand-alone perspective. And I suspect when you talk to others in the industry, they would say that they're also benefiting from continued expansion of stand-alone procedure volumes in various technology modalities.

I've said this before, there can be a lot of winners when you're going from a market that's 500,000 eyes to 20 million, 21 million eyes. While I hope that the majority of those are done with an iDose or an iDose and infinite or infinite, I have no doubt that other technologies will also play a role in that. And we want those conversations to be happening because we're trying to change standard of care here, and it helps when it's not just one voice.

So I've made it almost a whole 10 minutes before I would say...

I'm impressed.

I work at these things. iDose. So what has surprised you about the iDose launch in 2025? And what we were like, yes, that's what we expected?

I think we -- I continue to be a little bit surprised by getting over these last couple of MACs in their professional fee schedules. And I would not have necessarily predicted coming in that we'd still be trying to turn over those river cards. When you live it, you see how that happens. And -- but at this point, we've had established professional fee schedules with Noridian and Novitas for some time. These are very large MACs covering the biggest chunk of lives.

You most recently saw NGS come on board after the third quarter call. And so whether it's expectations or just frustration, you really want to get to a place where physicians can make decisions based upon clinical determinations and not be held back by things that are not clinical like whether they can even get paid to do a procedure. And so getting through that has probably been the biggest one.

I think where we've been it's met expectations or exceeded, it keeps coming back to the actual performance of the product. And that's what makes us so bullish about the future. I mean the number of physician texts and conversations and just exceptional outcomes that I receive personally, let alone our field team and all of our clinical personnel and folks alongside of that, you can't help but be excited when physicians are excited about what they're seeing.

And again, one of the hard things for the investment community is translating that and then overlaying reimbursement-related considerations and not getting ahead of yourself in terms of the way a product like this ramps. But I'm excited that we're doing it off of a foundation where the product is terrific clinically and that continues to exceed our expectations.

So a lot to unpack there. I'm going to go first with investments community getting ahead of ourselves. I think we all see the stock price year-to-date and a nice rebound over the last, whatever, weeks, months. But do you think that the investment models as you see them, and Alex, this may be for you. Do we have the right numbers now?

Well, I can talk about the top line and Alex can talk downstream from that. But I think we went through -- this is my own interpretation, and I think it's up to all of you. I think late last year and going into the beginning part of this year, there was a degree of unbridled enthusiasm around what it was going to mean in terms of the ramp. And that was based upon hard data, which was surveys and clinical and investigator enthusiasm for the product.

What often gets missed in situations like this and that is that while a physician may want to use it for everything, they have administrators and other folks who are saying, not until we know we're going to get paid, right, or that you're going to get paid or the various things that act as headwinds to any adoption, but particularly in procedures and procedural pharmaceuticals.

And so I just think that there's -- that's what got ahead. There was a mismatch between taking what was coming from the surveys and putting the proper market access headwind overlay on that. I think we then went into a period of time where, to a certain extent, I understand there's a little bit of an overreaction where people say, well, okay, show me. And then as we continue to make progress and obviously, the trajectory we've been on over the course of the year and as you saw in the third quarter and kind of what's implied in next year's guidance, we continue to see a lot of opportunity, and we're seeing really attractive growth in our U.S. glaucoma business driven by iDose.

So I think I can't speak for every analyst and every investor and every hedge fund and every [ long ] in that. But I think in general, the Street has gotten to a better place in terms of expectations around iDose than they certainly were coming into 2025.

Alex, do you want to jump in?

Sure. I'll just comment on the rest of the P&L. Joe talked about the top line, which has been the focus. I think some of the answers I'll give go back to what you originally asked for is, which was if you think about where we were 3 years ago and you think about the financial profile of the company and where we are now, it's changed quite a bit. Three years ago, we were burning cash because we were investing in building a facility for iDose.

We had a convertible debt that was hanging over our heads. And we are waiting our way through towards an iDose approval and looking forward to those revenues and the things that could come out of that, but not knowing whether we would get approval, et cetera. Here we are today, and the convertible debt has been retired. We are largely back to our normal capital spend on an annual basis, which is really capital light.

And we're getting to the point now that we've been aiming for, for a while, which is to get back towards a cash flow breakeven type of profile in the company. So all of those things have materialized over the course of this year, this show-me year, as Joe referred to. In addition, you start to see leverage in our model. So even though revenues are increasing and our operating expenses are growing, we're still showing leverage in that model as we continue to progress the company financially. So I think we're getting towards that right place and where we're heading in the next several years, we're heading in the right direction.

Excellent. I want to spend a little bit of time on the CAC panel, which freaked a lot of people out and then seem to be an nothing burger. Is that the right interpretation of what went down?

I think that's the right interpretation from an investor sentiment perspective. And so I totally appreciate that. I think if we were to look at it, and I'll repeat what I said before it and then during and then after.

Yes, after.

Yes. It really -- this is a part of the process. And so from our standpoint, the actual event of a CAC meeting is a step in the education process for these MACs. I think people forget that these same medical directors, these same institutions are dealing with an Alzheimer drug and an oncology and a glaucoma and all the various things around it. And so to expect them to be experts in how these things all work is a bit of a bridge too far. And I think you saw that in the CAC meeting itself, right?

I mean I think clearly, there's a process in which they're trying to figure out what does standard of care look like, how is it shifting? How does iDose play a role in that? What evidence is associated with that? And the way they ask those questions can be messy because -- and highlight the fact that they don't totally understand. And if it was just up to the clinicians, this would all be easy.

But you go into any of these processes where the tug of war is between what you know is the right answer, what they understand or don't understand, how you educate them through that process and then how that does or doesn't land in policy. And the reality then and now is that the path forward has scenarios that are positive for us, scenarios that are neutral for us and the industry and scenarios why I think hopefully are a little bit more remote are negative. And in which case, requires more advocacy and more effort to make sure they're properly educated and get to the right place in any final "LCD" that would happen.

And in that latter part, if it emerged, I think it probably becomes a bit more of an investor trading sentiment issue and something that really fundamentally changes the way we view the near, medium and long-term opportunity associated with iDose and the market and everything we're going after for interventional glaucoma.

So I thought the -- and we thought the physicians who were selected, we have no say in that, right? That's just the medical directors and the CAC members that were participating. They did a really nice job of -- it's never exactly how I would answer every single question, but they were, I think, thoughtful and objective around where everything is at and the amount of evidence that's associated with iDose and why it's supported and should be a tool that's in their armamentarium to actually treat this disease. And so from that standpoint, we walked away as pleased as you're ever going to be around a conversation like a CAC meeting.

I mean the conclusion essentially was it should be part of your toolbox?

Yes. And really, I think it should be a part of the tool. The exact deployment when and where is still something that you have to have more utilization. Physicians have to continue to figure out. I mean you can make debates that it is a topical medication. Topical medications are first line. And the only thing that's different about iDose is that you've taken patient non-adherence and compliance out of the equation. In which case, you'd argue that for many physicians, they would want to have a first-line therapy.

But we're not naive enough to think that's where it starts. It doesn't and it never does. But their point was you have to let some of this stuff play out for an informed physician to be able to say, this is what we think the standard of care is starting to look like. And if you do that too prematurely, you're actually stifling obviously, clinical innovation and what they all want to be able to do in practicing medicine and trying to tackle this disease.

So at this stage, my math is correct, you have 5 of the 7 MACs that are reimbursing. What does it take for the next 2?

I think it's actually 4, right, on the professional fee. I mean they're all reimbursing on the facility and the drug. One of the 7 still has some issues on the facility side, but the drug is getting paid in all 7. 4 of the 7 representing about 70% of the Medicare lives are now have a professional fee schedule and 3 representing the remaining 30% still have not posted a professional fee schedule yet.

What does it take for those 3?

If I had a perfect answer for that, we would have already done it. It's a process associated with just continued education. I think the only way you really get through it is continuing to have clinical demand, providers submitting claims, some of those claims getting denied, some of them getting paid and getting through the process to where it eventually gets enough volume where the MAC itself has to put on the professional fee schedule and adjudicated in a more streamlined way.

And there's no statutory level, process, et cetera. It is up to each MAC independently into how they price, what they price and when they price any Category III code. I'd like to be optimistic that says that now you've got 70%, including the largest 3 MACs that that's pretty good evidence about how it should be valued and how it should be adjudicated.

But you still have to engage [Audio Gap] extent the societies continue to be a part of that education process. And I can tell you this I think our market access organization, no one will be happier in this country [Audio Gap] on there because that means they'll stop getting the daily questions from Tom and myself.

Is there a stage, and I hope you say yes, where we're not monitoring the reimbursement arena for iDose?

Well, I could answer that yes to satisfy what you hope.

Don't do that.

But I'll give it a more nuanced answer, which is I think on a relative basis, sure, right? I mean I think any time you're pioneering new categories, and driving new treatment modalities, there's an inherent messiness in establishing proper access and coverage and payment. And that's going to come with opportunities of fits and sometimes it starts and then sometimes there will be pullbacks. And there's just inherently some volatility that all works itself out in the way our health care system works, right?

But there is a point where you get through, I'll call it, enough of the over the hump where back to my earlier point, physicians stop having to think so much about reimbursement and they can start thinking just about what do I prefer for my treatment algorithm. And that's where you want to get to as fast as humanly possible. And that's where your sales force and your medical affairs colleagues and everybody else has a lot more fun because they're able to engage in clinical conversation, not can I get paid properly and run my business conversation.

My caveat to all that is as you know, having done this for a long time, it doesn't matter what -- you're never completely out of the woods on these things, right? Even if you're in today's world, super successful with a pharmaceutical, you might eventually find yourself negotiating with CMS around that price if you get on that grid. And that's a high-class problem, but you might get there. And commercial payers and Medicare Advantage and everything else, as you get more and more on their grid, there's more and more things that kind of come up in and around that.

So I don't think you ever are done. And I think for our market access team, they've got a lot of job security because of the way our system is structured, right? So you're never totally out of the woods.

When all 7 are reimbursing facility and professional fee, do you have a number that's a revenue run rate?

Well, I mean -- so in that scenario, you're talking about a little less than half of the Medicare covered lives today based on MA versus Medicare fee-for-service. And then you've got another, call it, at least based upon the iDose clinical studies, half of the overall patient population are non-Medicare age that are around there. And so I'm just doing this, honestly, kind of on the fly this way for you, Joanne.

But if I think there's 21 million eyes out there and I say, let's say, half of those are non-Medicare age and half of those, just to make the math easy, are Medicare, you're talking about a 3 million, 4 million, 5 million eye market that you're going after for those patients. And not all of those are found and diagnosed and all that kind of stuff. So you continue to haircut that down, but you are going after a pretty large patient population.

Glaucoma is a very real disease that affects an awful lot of people, both diagnosed and not suspect, high pressure, various stages of glaucoma damage. And today, it's one that's severely undertreated in the context of prescribing drops. Such a large percentage of those patients who are prescribed drops today never show back up. It's just unfortunately one of those disease states that it's asymptomatic and slowly progressing and patients hate taking their drops.

And as a result, they don't and they're not reminded on a daily basis they should be. And as a result, they're the ones who unfortunately show up with late-stage disease several years down the line. And our goal is to try to prevent that. And I think at least to the point of your question with the Medicare patient population, I think as we get those prophies on, we can start trying to really go after it.

You've got a next-generation iDose in the works, which may address things like can it be done in the ASC, can you do a secondary implant. Can you remind us what the features are of the product and what the time line is?

Yes. So the iDose Trex or extended version of that, what we've said is it's designed to carry approximately twice the amount of drug payload as the existing TR within a very similar footprint. It's just through kind of, I'll call it, next-generation engineering in the design, we're able to hollow the canister out a bit more and achieve a larger drug payload.

And so our hope is that you can provide an even longer duration of effect in that product. And our clinical studies are underway, and we've talked about it being something that we hope to have on the market as a part of this planning period, if you will, or this decade how you look at it. And we'll obviously have more updates as we get closer to having full enrollment and all the things that are around that to dial that in for you.

It is one of the belt and suspender approaches around being able to provide multiple Glaukos technologies for lifelong interventional glaucoma therapy, right? The average patient has glaucoma from diagnosis to passing of 21 years. And so you want to have whether it's multiple implantations of iDose TR or TR plus TREX or iStent infinite or the various things or other competitor technologies where you can continue to manage that patient in an interventional way over the course of that life cycle with the disease. And I think TREX will be another important step in that to provide even longer duration of effect for patients in a single procedure.

So does that allow for secondary procedures? And does that -- will that allow for in-office procedures?

So I'll do the latter first. In-office is a separate equation. In a theoretical and clinical sense, you could do in-office procedures with iDose TR. You could do it with TREX. We also have an injector system for doing that, that we're taking through the clinical paces right now called TRIO or in-office. Any one of those can be done in the office. The in-office component of all this really is more of a turning on the coding side of that for in-office coding at market access, site of service 11, so outside of the hospital ASC environment. And you do that by applying to the individual MACs and requesting that, that coding goes on, they go through a process to enable that. And that's something that we expect to do over the course of next year.

Okay. Epioxa, I think everybody was surprised when you gave the ASP on the last earnings call. Can you remind us of how you're approaching this market? I have 14 other questions, of course, but let's start with that one.

Yes. So we tried in our own subtle way to signal to folks that we saw this as a rare disease drug leading up to it. And I know with all the focus on iDose, that probably got lost in the shuffle a bit as we were kind of leading up to it. So I know it did surprise some folks. But there's a fundamental reality of where we're at today in treating patients with keratoconus and that is we're currently treating about 10,000 patients.

You do the math, it's whatever your model shows, 18,000, 19,000, 20,000 eyes. Any way you slice that, that's a rare disease. Similar volumes for drugs like OXERVATE or TEPEZZA in ophthalmology. And certainly, when you look more broadly, many would actually classify that as ultra-rare disease, not just rare disease in terms of the patient volume. And that was a recognition for us as a company that is on our own journey post Avedro acquisition in realizing that to get patients found, detected and access and ultimately treated, you had to look at it completely different.

It's not the same as treating with an iDose where with 21 million eyes, doctors wake up in the morning and go to bed at night thinking about glaucoma or some form of that. It's prevalent every day in their practice in some way, shape or form. Rare disease doesn't work that way. And so you have to take the mantle, if you will, and make sure that you're driving education and awareness so that people are asking the question, do I have keratoconus when they're seeing that visual disturbance and the change in their vision of their optometrist, of which there's 50,000 of them out there and of their ophthalmologist, whether that's comprehensive or cornea or otherwise.

And so you really have to take a totally different approach to how you're set up as an organization, the tools and assets, both from a human resource perspective as well as supporting that patient in their journey and all the various things I was sort of alluding to, it's a complete transformation. And one of the things that we were excited about with the approval and being able to talk about this is we've been hard at work for this for 3 years. Alex has been a part of helping -- we've been hiring people from the Horizons and other organizations in the world that know rare disease and know direct-to-patient advertising and all the various things there quietly behind the scenes.

And now they get to really run with this product launch. And I think we've built a unique foundation for rare disease drugs. And Epioxa is the first. I hope there's more. We certainly have more in our pipeline that we can actually bring to market to help these patients.

But it's the same doctor who's doing Photrexa now that will be doing Epioxa?

Many of them.

Many of them?

Yes, it won't be every single one, but many of them...

So they already know where the patients are more or less?

We know where the existing funnel. The challenge is that the -- there -- it breaks down at every single level. We know that a huge percentage of actual patients out there, we may ultimately find it's not a rare disease. We may even find that it's a rarely diagnosed disease today. It doesn't change the go-to-market strategy because you still have the same fundamental problems. But today, we've got to go.

So the patients that are out there being found today, yes, we know where they're going. We know what optometrists are sending them and what ophthalmologists are treating them, and many of those will be our customers as a part of this. The question is not enough people are getting to the optometrists to get screened and not enough of those that are getting to optometrists are being properly screened for keratoconus. They get misdiagnosed as having another visual acuity issue.

So finding them and getting them screened and then getting them referred to a treating ophthalmologist, every step of that journey, there's significant breakdowns in the way, and they require significant investments to get it going in the right direction. But yes, of the 10,000 patients that exist today on an annual basis, we know where they're being found and where they're going.

My memory is that when the company that Avedro purchased, when they launched Photrexa, it wasn't well launched. Is that correct?

Well, that was -- we acquired Avedro. Avedro had launched this. This was the foundation of Avedro was cross-linking technology as a part of it. And I would say it differently. I think it was launched with a different intention. So when -- I don't want to put words in the mouth of the original founder of Avedro, but I think in general, they viewed it as more of a LASIK adjunct procedure. And so the idea that you could do a refractive procedure and then use the cross-linking to strengthen the cornea post LASIK. People call it LASIK Xtra as an idea, and some of that is done in Asia today, in particular, was the real strategy.

So it was much more about a cash pay refractive market. But the challenge with that is as it became clear that the real opportunity was treating this rare disease in keratoconus. And you move into the reimbursement world, and this is what you'll remember from that time when Reza and others were involved there is that the pivot they had to make into -- from a cash pay drug into a reimbursed one was a very painful one for them and also one that comes with a whole host of unintended consequences around the way, in our case, the Medicaid drug rebate program works and other things that are there that you're right, in retrospect, you would never launch a rare disease drug this way.

But the why they got there wasn't because they really weren't trying to launch it as a rare disease drug for keratoconus. So this with Epioxa becomes the first time that we or anybody associated with this cross-linking is able to try to do it the right way from a market access, from a payer perspective and certainly from a disease awareness detection and treatment perspective.

Spend a little bit of time on the income statement. And I know I asked you this last year, I think I'm going to ask you this once a year. How do we think about profitability and reaching it?

It's a great question. Well, luckily, Joanne, our focus hasn't changed from last year, which is, again, in the short term, our goal is cash flow breakeven and living within our means, we like to say internally within the halls of Glaukos. And what that means is we look to balance our revenue growth and revenues generated against the investments we need to make in Joe's organization to launch these great products, in our R&D organization to continue to feed the pipeline that Joe's referenced as well and -- but to do so in a responsible manner and really, again, break -- or breaking even on our cash flow.

So that's in the near term. As we progress throughout, let's call it, the medium to long term, then we start to look at the things you're referencing, which is that pathway to profitability. And we are very fortunate to have a business that has high gross margins. And with those gross margins, that will allow us to continue to invest in the business, both on the SG&A and R&D side, but still realize operating margins in the 30% to 35% range, we believe. And so that is the pathway to profitability is over that medium to longer term where we get to that point where we can do what we're talking about doing and still realize those operating margins that we should do in a mature business.

My hope is to help Alex by continuing to grow the top line faster than expectations so that it's even with our ambition on the development side that we can outpace it, in which case, you just get the natural benefit of the leverage of the margin profile. But we'll continue to do our best.

What do you think at this stage investors are missing?

Well, you're probably better positioned to address that than we are but...

They have my views. But I'm curious of yours.

Well, no, I think this is always -- investor relations in that sense is a journey, too, right? And I think we're in this unique point in time where I hope that we're starting to shift from the drama from an IR standpoint of small -- they're important, but smaller things in the grand scheme of what it means for the next 2, 5 and 10 years to a better understanding of where this company is really going, the markets that we're playing in, the breadth of our portfolio, both commercial today and the pipeline behind it to achieve that. The kind of conversations that we're trying to engage more in is for example, in iDose -- do you believe in interventional glaucoma? Do you believe when you have the conversations that glaucoma is an interventional disease? We do and most of the physicians we talk to do.

But from an investor standpoint, do you? Because if you do, then not just Glaukos, but multiple participants in the industry are going to win over the next 5 and 10 years because of the opportunity to do what's right for these patients and the commercial opportunity that comes with that.

That conversation and being able to start seeing the thematic elements of what is resident in Glaukos now that we're not $50 million of revenue or $100 million of revenue that we're actually starting to become a place where you can count on the stability of us and the growth that's there, understanding what that rare disease investment means what opportunities are resident within our pipeline, thinking about the early shots on goal we now have in retina and the things that are around there and really starting to look at hopefully the, I'll call it, the long-term risk-adjusted opportunity associated with our story more than, say, tomorrow's trading event or a short thesis on whether you're going to miss the iDose number by $100,000 or beat it by $100,000, I think, is still -- we're in that transition.

And I think as we continue to deliver on iDose and now with Epioxa, that frees people to worry a little less about those things I'm referencing and focus a little bit more on the long term. And I think that excites all of us from an Investor Relations standpoint as we think about the coming years.

In our last 2 minutes, when we're here this time next year, what will we be talking about?

Well, I hope we're talking about an elevated version of some of what we talked about here, which is I hope that we're largely putting behind us the reimbursement-related conversations associated with iDose and even to a certain extent, Epioxa and starting to talk a lot more about the clinical adoption paradigms and the opportunities associated with that and the pace in which we think we can continue to drive the standard of care shifts I'm talking about and really having the foundation much more poured with and solidified so that we're really talking about the offensive strategies we've got versus continuing to kind of get through this piece.

But we're just going to keep putting one foot in front of the other and trying to grow the business between now and then to the maximum extent possible. And I'm -- we're all bullish around what next year and the years to come have in store for us. And now it's just about heads down and executing.

Joe, Alex, thank you so much for joining us.

Thanks, Joanne.

Thanks, Joanne.

Good morning, everyone. Thank you so much for joining. I'm Danielle Antalffy, the U.S. med tech analyst here at UBS. Very excited for my first time ever to host the Glaukos team. Alex Thurman, Chief Financial Officer; Chris Lewis, Head of Investor Relations. Thank you, guys, for making the time to be here.

Thank you for having us.

Thank you. Happy to be here.

Yes.

Yes. So maybe let's start. You guys did just report earnings like 2 weeks ago, I think it was. So maybe talk a little bit about the quick hits from Q3, and then we can launch into Q&A.

Sure. So we are really proud with our Q3 results. It was a great quarter, lots of records, record glaucoma revenues, record total revenues. And we are really excited to report $40 million of iDose for the quarter. So a really nice sequential step-up from Q2. And so overall, it was a really fine point. And as you know, we provided an update of guidance. So we beat the Street, and we kind of beat and raised our guidance for the year from up to $490 million to $495 million. So we're excited about the continuation of the business and how we're growing and as we close out the year and then go into 2026.

Well, and that's my next question because, of course, everyone is already focused on 2026 and how to think about especially the iDose ramp in the context of you do have the iStent business and sort of how they coexist together as iDose is ramping?

Yes, it's a great question. I mean, quite frankly, we're excited about iDose, and that is a focus just given the opportunity and the expansion of the TAM, et cetera. And so as you can imagine and given its price point, we're continuing to focus on iDose and trying to build that business and to really spread the message that we've started with this interventional glaucoma, where we believe that with patients that have glaucoma or even ocular hypertension, there's an opportunity to intervene earlier and really help them with their disease.

And while the messaging is always about can we overcome the challenges that patients have with drops. We know they work when they're taken. Challenges that patients don't take them, and there's lots of studies that show that. So can you intervene with an iDose or even with a stent earlier in the stand-alone setting and help prevent them.

So as we go through this business, we're starting to build that side and continuing on, and you see that in the iDose progress. And then obviously, we announced the approval of Epioxa, and that will be the second big driver as we go into 2026. And it's exciting as a company now that we have multiple drivers to drive towards what we think will be a great near-term period of time for the business.

Yes, yes. I mean, this is timely, too, and I'm going to jump right to tomorrow and the CAC meeting. And we actually have done some work on this on our own. I'll tell you what the takeaways we've heard are as far as what to expect out of this meeting. But curious what your guys' thoughts are as we head into this. So the work that we've done suggests that this could potentially restrict iDose use as stand-alone, so not in combination with cataract, not in combination with another MIGS procedure. What if that was the outcome, what does that mean for iDose?

Well, I think maybe taking a step back just for the audience, I think tomorrow's meeting, again, just to reiterate, is a great opportunity for MAC to learn what iDose is and for the CAC members to better understand iDose and the value it brings to patients in terms of addressing that noncompliance with topical medications. And so we're excited for iDose to have that forum tomorrow.

And I think importantly, for doctors to share and understand and talk about the Level 1 clinical evidence that iDose really has, right? And I think that's such an important piece of it that we're really proud of iDose studied as an FDA-approved pharmaceutical, 2 Phase III drug trials, over 1,150 patients across both of those Phase III trials, obviously showed great efficacy and safety. And we think that's a really critical piece of that in terms of what that meaning is really geared towards in terms of understanding the clinical evidence around iDose and the value it brings to patients.

I think another important piece as you think about the outcomes, and there's certainly pluses or minuses, and we can talk about that. That's obviously, I think, been written on by the Street quite a bit here over the past several weeks.

But at the end of the day, it comes back to the Level 1 clinical evidence. It comes back to the fact iDose is approved as a pharmaceutical. And so when you think about what that means and the contraindications, I think that's a discussion to be had and hopefully some education learnings for tomorrow. And then the continued evolution of the peer-reviewed evidence, right? And we've written about that, and you've done a nice job. I mean there's 15 peer-reviewed publications now across a variety of settings. And we're going to continue to expand that. That's been the goal.

Even before we got approval, we were planning for that, and you've seen that play out, and that will continue to play out in terms of supporting that evidence. And so I think at the end of the day, we feel -- I think continue to feel confident in how this plays out. Ultimately, I think there's a lot of enthusiasm and excitement around the product and what it means for patients. And our goal is to try to expand that patient access as much as we can.

Yes. Okay. Okay. And first of all, Angela gets the credit for all the work that we did on that, not me. But -- so it sounds like you think tomorrow could actually result in -- I mean, tomorrow itself is more an information gathering session, I guess. But are we at the Street overfocused on this as far as what the outcome could be?

I think it's just early in the process.

Yes.

To be fair. And I think Wall Street is going to speculate one way or the other.

Yes.

That's not our job. Our job is to just focus on executing what we can execute. Again, I come back to all those things we talked about being -- having the most robust Level 1 clinical evidence and the true value it's bringing to patients. And so I think there's a lot of enthusiasm and support out there from a physician advocacy perspective. And hopefully, that continues to show going forward.

Okay. And you are already annualizing at $160 million -- $240 million. I can't do head maths right now. But...

[indiscernible] run rate.

It's been a long 2 days. So as you exit 2025, why isn't the right way to think about iDose in 2026 as something well north of that?

Well, I think it's a good question. And if you look at our fourth quarter guidance, I think most of the Street has us kind of exiting at a $180 million run rate. And then the Street models have us at, call it, $220 million roughly next year in iDose. And exiting at $180 million, it's not a big stretch to get to $220 million.

Yes.

So that's perfectly within the ballpark, so to speak. If you think -- if you step back and you think about what are the opportunities that iDose has from a market standpoint, we've talked about the fact that when we started our journey as a company, we were limited to the combo cataract market with a kind of a TAM of 500,000 eyes that were being done. And with going into the stand-alone market and expanding that market size, we talk about the fact that there's probably 22 million eyes that have ocular hypertension and glaucoma, of which 12 million are actively being treated -- diagnosed and actively treated today.

So it's a huge step-up in the opportunity for sure. And that's really -- that goes to this whole idea of this messaging around interventional glaucoma and trying to get in earlier and trying to help these patients because it's such a large patient population out there, of which today, most of those people that are diagnosed and treated are using drops, right? And unfortunately, as we know from the studies being done, it's largely ineffective.

Let's talk about interventional glaucoma because I think that it's important. And I was at AAO, and I felt like that was a very big topic. And so I guess my first question for you is, how are you guys measuring success for this market and the strategy there? And where do you see this going? Like if you look at MIGS procedures then say, what percent today is in stand-alone? And how does that ramp over 5 years -- where are we in 5 years?

Yes. That's a great point. I think as we measure success, we think about it, it's the things like you saw at AAO, right? How is the physician community adopting the messaging and getting excited. And when we see KOLs out there that are preaching from the pulpits like another conference like that, about the benefits of interventional glaucoma and the need to fully embrace it. That's one measure of success.

And then you break that down into the next level of providers that are out there and they're adopting that and they're looking for opportunities to do that. And then hopefully, the patients get on board, right? And they understand, gosh, I hate my drops for whatever reason, and I don't like how they feel or I don't like how I look afterwards. And so what are the other alternatives and then that education process happens. All of that will lead to what we think is successful, right? It's getting those patients treated earlier in their paradigm and helping them relieve themselves of the burden of drops and really controlling those disease and those eye pressures earlier on in their disease state. That will be the measure of success.

Okay.

As we go forward, what does it look like in 5 years? You talked about the mix of stand-alone versus combo cataract. Again, we would hope that the majority of these procedures are done in a stand-alone setting because the market is so much bigger and there's so many more patients in that. The only reason we were in cataract to begin with was that's how we were initially approved with our stents and the FDA wanted us to go in there. So now we're luckily between iStent infinite and now iDose, we're able to go outside of the cataract market and really try to drive home that messaging around IG.

So what is the lift to drive growth in this interventional glaucoma market? Like thinking from a logistical perspective at the practice, like changing standard of care is hard. So maybe talk about some of the areas of friction there.

Well, it's always -- we've always said it's going to be a 5- to 10-year journey to change a market. And we've built markets before. Thankfully, if you look back at the iStent, there wasn't a MIGS before we started with the stents, right? And when we started that journey, there were some surveys done in some of these society conferences where how many of you doctors would consider using a MIGS product. And back then, it was a very low percentage.

And now if you ask that same question, it's going to be 90%, right, or plus. So it's a similar process where you have to go out and you have to get your KOLs to buy into this and understand it and adopt it. And then it just kind of trickles down from there, along with our efforts around just advertising and talking with doctors and meeting with our customers and really educating them on the benefits of that.

And so it just takes time. There's a lot of customers. There's a lot of education and a lot of things that happen. And then you do what you saw at AAO between AAO, ASCRS, those types of society meetings where you can, again, really market that concept of IG. We were very pleased to see at ASCRS this idea that they had -- and it wasn't put on by us, but we've certainly supported it, what a session they called the business of interventional glaucoma that was put on by the KOLs. And so those kinds of things start to snowball, we hope and really drive this in the next 5 years.

Yes. It was very evident at AAO that the same messaging. So...

It comes back to the clinical need, too. I mean, what -- like what's the driver of this over time? And it comes back to the noncompliance on topical medications, which have historically been kind of the standard of care for better or worse than glaucoma, right? And so when you look at the literature and the stats, 50% of patients don't fill their first script on a topical lowering medication, 90% of patients are noncompliant at the ear.

So when you think of that, like drops can work when they're taken, they're just not taken. And so when they're not taken, they're not effective. And so I think it's -- you have tools now through stand-alone interventional glaucoma approaches for us with iStent infinite and iDose and hopefully more to come over time that you can intervene earlier to help patients slow and arrest the progression of the underlying disease before you get to later stages in tubes and travs and ultimately blindness. And so it's really a full-scale transformation of that treatment algorithm.

And so in the context of that and the growing interventional glaucoma market, how -- what is -- this year, you faced very well telegraphed headwinds in the iStent business. What is the right go-forward growth rate, a normalized growth rate for that business?

Yes. I think from an underlying market perspective, we're going to anniversary or we have anniversary kind of the LCD headwinds that basically restricted 2 or more surgical MIGS devices to be used in the same procedure, right? And so that was obviously a year-over-year headwind from a market unit perspective, not just for us, but for all companies out there within the combo cataract MIGS space.

I think you get back to a place of underlying market growth over time, certainly, if you're looking in the combo cataract market, I think a good benchmark, obviously, is cataract surgery. So whether that's low or mid-single digits from a market perspective, that's probably not a bad place to be in terms of getting back to kind of a steady state. For us, I think you have to consider -- you have to balance that with the considerations of iDose, and that will obviously be the primary focus for our sales force and our leading tool out there. And so I think you have to kind of balance that a little bit when you think about kind of the growth specifically for our iStent or non-iDose franchise as it relates to just the vast opportunity we have with iDose going forward.

Okay. Okay. Got you. We did touch on the CAC meeting tomorrow. But just in general, where are we today with MAC and who's paying, who's not? I assume we'll get some more color tomorrow, at least how they're thinking about this. But curious about, as you think about 2026, where are we going to be entering '26?

Yes. So it's been a big focus of ours, right, for those of you that follow the story is to build the foundational market access pillars to support coverage and streamlined payment and building that reimbursement confidence at the account level over the past really 1.5 years, 2 years now. And we're in a really good place now.

All 7 MACs are paying on the J-code in a streamlined manner. The facility fee is paying across all the MACs in a streamlined manner. And now 4 of the 7 MACs have pro fees posted to their schedules, most recently, NGS in August, which is kind of the second or third largest MAC. So I think within those 4 MACs that covers about 70% of the Medicare lives. There's 3 remaining WPS, CGS and Palmetto. And so we're working every day to get those established. Those 3 are part of this 5 working group that is going to participate in the CAC meeting tomorrow.

So we think that's a great opportunity for us and doctors to educate them and maybe hopefully, that's a step in the right direction in terms of getting the pro fees ultimately posted and streamlined. And so from a mix perspective, it takes some time to operationalize once they get posted to the prophy schedule, it takes some time to operationalize that in terms of pulling that through in terms of volumes. And so what we said on the third quarter call was that those 3 MACs that have been -- have the pro fees established for some time now, Noridian, Novitas and First Coast, those accounted for about 80% of our iDose volumes, which was largely consistent with the second quarter.

We're hopeful that NGS starts to layer in there as we exit the year into 2026 being one of the larger MACs. But I think that's an important point to think about that we've shown really nice sequential growth with 50% of MAC still not on board yet and operationalized. And so I think that continues to -- when you think about '26 and beyond, that layers in and starts to hopefully continue to support that growth trajectory over time.

So you're saying the Street is too low with that [indiscernible].

We are not commenting on '26, to be clear.

Okay. Let's talk about Epioxa. So that was an exciting approval, finally got that approval. Very few people focused on the right. I remember when we first started talking earlier, we have this whole other business here, too. Don't forget about that. Maybe talk -- remind us a little bit about what you guys talked about on the Q3 call and the ramp of that and how that's shaping up for 2026 and can impact top line growth?

It's very exciting. I mean, first and foremost. So it is if we go back in time with the Photrexa treatment, Photrexa was the one and only FDA-approved therapy for keratoconus. And it worked. It stopped the progression of the disease, but the challenge was with patients you had to debride or scrape off the outer part of your cornea to apply the drug, which was something that caused a long recovery and a painful recovery, and that was hard.

Now with Epioxa, we have the opportunity to treat those same patients without taking off the outer part of their cornea. So it's an exciting new development. The other thing that we commented on, on the call was the fact that we -- when we bought the business from Avedro, we've had it now 6 years, and we've made substantial investments over time, but we really haven't been able to penetrate the number of patients we think are out there. It's kind of held steady at around 10,000 patients being treated per year.

And we believe based on our data that, that is only 1 in 5. And so there's potentially 50,000 patients out there with keratoconus that's progressing and not getting treated today.

And so with Epioxa, it was an opportunity to really reset the whole kind of dynamic and market around keratoconus, which would require substantial investments to find these. When you're talking about a prevalence of 10,000 patients in a U.S. population of, call it, 340 million, it's kind of like finding a needle in a haystack. And so that requires some investment. And so the price that we disclosed on that third quarter call was obviously a lot higher than Photrexa, but it allows us to make the investments required to find those patients and to help educate them, identify them, educate them, help them along the journey with their insurance, et cetera, to ultimately, we hope, get treated with Epioxa and really halt the progression of their disease and give them kind of their vision security back that they're not going to lose their vision in the future.

So that's an exciting time. How that ramps up this year is another step, right, in the whole process. And we've been on record to say that as we go through 2026, it's going to be a focus of establishing the market access for the patients. And it's important to know that this is a younger patient population. So it's completely different than iDose, right? You're typically in a Medicare age patient in iDose. But with this, it's going to be typically younger than age 30, most of them are commercial. And then a pretty good subset of Medicaid patients as well.

And so it's a matter of going plan by plan, state by state to get the coverage changed out from Photrexa into Epioxa and allow them to get treated through those plans. And then it will be a second step of going through our customers because with commercial plans, they typically have individual contracts with those commercial plans. And so we'll have to get those commercial contracts updated as well. And so we've already invested quite a bit in the apparatus, let's call it, to support our customers in doing that and to going through our payer relations and our reimbursement liaisons and helping them to figure that out. And so it will be a slow, steady move as we go through 2026.

The other thing that is always out there is the famous J-code. So we've talked about now that we have an approved product, we can apply for a J-code, but it takes 2 quarters of reporting that ASP in order to get the formal J-code established. So the first half of 2026 will be under a miscellaneous C-code and then you'll get into the J-code in the latter half of the year. And that's really when we think commercial plans will start to pick up more fulsomely is once they have an established J-code.

So heavy market development lift, it sounds like. So 2026, we should not be modeling $220 million in Epioxa. That's my takeaway. You mentioned the only 1 in 5 patients being treated. Why is that? Is it just that therapy just Photrexa was not?

Well, I think it was -- you have to remember, it's interesting that if you're a mother of a child that comes home from school and says, "gosh, mom, I can't see my book or I can't see the board very well anymore. Your first reaction is going to take them down to the local optometrist, right? You must think there's some issue with the vision. And so then it becomes a matter of -- there's 50,000 optometrists in the United States. And so of those 50,000, how many of them are aware of keratoconus or know how to diagnose it.

So that's another part of this launch is helping them to be able to diagnose it and then to be a part of a referral network that refers them on to the appropriate MD to treat it. And so that's all part of the process. And before with Photrexa, we just didn't have the financial resources to be able to do that. But with Epioxa, we think we will.

Okay. Got it.

It's not dissimilar like versus other rare diseases, just a structural kind of barriers out there. And given the kind of the patient populations and the number of patients, they're just harder to develop. And so I think that's why we're really excited to have the opportunity to kind of reset the way we're going to go to market and all those things we talked about on the earnings call. Ultimately, the goal and why we're doing that is to drive improved patient access over time and capture more patients and drive them to treatment so they can arrest the progression of the disease earlier.

Okay. All right. We talked a lot about top line, but let's talk profitability. As CFO. bring it on. So obviously, you talked about -- we talked about iDose and the ramp there. I mean potential leverage from a product priced at that price point as well as Epioxa. I mean, how do we think about the path to profitability for you guys?

Yes. It's a great question. One that I'll say overall is that our philosophy hasn't changed in the near term. And what I mean by that is we've been saying now for at least a year or more that our focus, once we were able to make the investments necessary to build a manufacturing facility for iDose and some of the things that went along that is we want to get back to a point where we "live within our means." And so we're driving our investments to match our revenues so that we are cash flow breakeven. And that's kind of the near-term goal.

We have to remember, like we've talked about that with Epioxa, it's going to require a great deal of investment. So even though, to your point, from a gross margin standpoint, the product is great, right? Wonderfully high margins, and we should expect gross margin to accrete over time. But we're going to have to take some of those -- many of those dollars and reinvest them in both the commercial and the patient support apparatuses that we have to try and drive patients to that treatment and treat them. But that's kind of the near term.

And then as we continue to expand and grow, we expect in the kind of the midterm time frame that we do turn to that profitability. There's no reason that the business that we have today with the gross margins that we have shouldn't be somewhere in the 30% to 35% operating margin in the midterm. And that -- and we'll drive towards that over time as we go.

Okay. Well, speaking of investment in R&D, so you guys don't talk a ton about what you're working on the pipeline, but you do give snippets here and there. Just curious, what can you say about the portfolio of R&D you have right now and how we should think about cadence of innovation?

Yes. I mean I think we try to balance it because if you talk -- I think we've disclosed we have 14 publicly disclosed pipeline programs across kind of a number of our platforms and a lot more behind that. But really, the focus is to build a world-class ophthalmology company. And so I think innovation is always the core of who we are. And obviously, that translates into best-in-class investment and historically and going forward. And so I think even like the iDose platform, we're in the Phase IIb, Phase III studies now with our next-generation iDose TREX, which kind of in the same form factor allows you to put about 2x the drug payload in there, so theoretically longer duration.

So we're pretty excited about the potential for that over time. For some of our other platforms, we've talked about iLution, which is a transdermal cream platform that doesn't get a lot of press today, but we're excited to go hopefully into clinical trials on iLution blepharitis this year. That's our goal, and that remains our goal. And so stay tuned on that.

And then earlier stage, but pretty exciting given how big the market is already is retina. And we are excited to go and announce our first-in-human clinical program started last year for that, and we continue to make progress there. Early but exciting as we say.

Okay. Well, we touched on this a little bit with the investments in the new product launches, but you do have a very strong balance sheet. How -- what is your approach to capital allocation priorities today? And fast forward to your profitable at that point, how it changes?

Well, I think the -- if I were to think about that, it is really around, again, you've already hit on it. Capital allocation primarily is going to be in the areas of our commercial launches because Epioxa and iDose are important to the future of the company. And we need to invest in the right way and at the right levels to support those launches for sure.

The second is what Chris was just talking about, R&D, right? And we have a lot of programs that he's talked about. There's more that we have that are not yet disclosed that are exciting opportunities for us as a company and that we'll need to invest in those as we allocate those capital. We're excited. We've done pretty well building and developing products internally organically. And so we'll continue to feed that as well and see where that brings us and again, to drive the top line growth in the medium to longer term.

And then last but not least, there's obviously -- we are -- we do have a nice little business development team that's continuing to look at a lot of things. What's most fun for our team now is that Glaukos, the name Glaukos is on everybody's radar. And so before we had to go out and seek things, but now opportunities are brought to our team. And so they're evaluating a lot of different things. But as you can imagine, just given our pipeline, it's a little bit of a high hurdle and so we'll consider those business development opportunities for sure, and we'll see how that works, but that will be kind of the third layer of how we allocate our capital.

Okay. Got you. Maybe let's talk 5 minutes left, dig a little deeper into the interventional glaucoma market because I think that is critical for not just iDose, but iStent infinite. Where do you think we are today as far as practices or surgeons that are already practicing this way, maybe as a percent of surgeons? And maybe talk about some of the hurdles for practices to implement this.

Yes. I think it's a surgeon-by-surgeon kind of case study. So there's not a blanket answer. But I think overall, to Alex's point earlier, we remain in the very early innings of the -- what we believe will be the kind of the IG evolution over the next decade. I think there are certainly some surgeons who are early adopters, as you see and have really bought in and incorporated it into the practice and all the considerations that we've talked about in terms of kind of operationalizing that and what that means from an OR standpoint, what that means from adding OR time or adding text or ODs or others to allow more time in the operating room for them.

So I think that's a component of it as it continues to evolve and you're seeing that certainly from leading centers and groups and practices out there. And our job along with others is to continue to drive that. I think one of the good things is it seems like there's a lot of support, not just from us, but with doctors and with other companies that you hear about. So I think you see -- hopefully, that kind of benefits everyone given the market opportunity over time that we hope to unlock.

And in those practices that have been able to successfully implement this, how are volumes growing? I assume volumes are growing actually faster at those practices.

Yes, 100%. I mean I think it's probably one of the areas if you're a doctor, I mean, getting into interventional glaucoma is one of the both from a procedural perspective, business perspective, all those things, it's one of the fastest-growing opportunities there is over the next decade. And so I think it comes back to like you see big courses now alongside society meetings. I mean that had never really happened before, but it's a testament to the opportunity that provides doctors and practices over time.

Okay. Got you. We didn't touch on the international business. So maybe talk about the outlook for that business. What are the different growth drivers there?

Yes, the outlook is good. We've been very pleased to see the growth continue strong -- probably stronger than expected. We called out the fact that we expected competition in some of our bigger markets this year. But the growth overall in that business has continued to be strong, and we expect it to continue next year. One of the biggest drivers, to be fair, is the fact that we just got iStent infinite approved in Europe under MDR.

Yes.

And so that will allow them for the first time in, I don't know, maybe 5 or 10 years that they'll have a new product to go out and they're excited about it. The excitement was palpable at the CRS meeting around iStent infinite and what that can mean to patients in Europe. And so that we would expect to be a good nice driver in Europe next year.

And are there different hurdles in Europe in the way they practice to getting more people doing stand-alone than the U.S.? Or is it pretty similar?

I think each market is different. And we...

Like even country to country.

Yes, we're used to that. And from a market access standpoint, each territory is different.

Yes. Okay.

The good news is a lot of these international markets, we're still, I'd say, in the early stages of unlocking the full potential there. And so I think we think there's a lot of continued room for growth. The growth thus far has been broad-based across our 16 international direct markets and so that's been really encouraging for us. And we're -- the Infinite MDR certification was -- we were waiting for that for quite some time, and we're really, really pleased to get that. And I think it's still early, but the excitement, launching that at ESCRS recently, I think the enthusiasm around that product and what it means for some of those markets, we're excited about.

Well, less than a minute we have left, stock has been volatile. Market has been tough. I mean, what do you think the biggest disconnect is between the perception on the Street or where people are focused versus what you guys are most excited about?

Well, I can't speak to what the stock traders do. That's kind of a different world for us. And we are really just focused on building a business and really growing Glaukos treating patients. And so there will be volatility as there always is in this industry as you go through market access challenges and hiccups and CAC meetings and things of that nature. But if you really just step back and you look at where are we headed as a business, what are our opportunities? What are our products? Do they address them? Are they effective and successful in the hands of surgeons with patients? Those are the kinds of things that we drive on and we again, we look at where are those unmet needs within the patient population and can we address that as a company and can we go after that? And you've seen that with the stents initially. You've seen that with iDose. You see that with Epioxa, and then you'll see it some more in some of the pipeline stuff that we're joining.

And with that, we're out of time. So thank you so much, guys.

Thank you, Danielle.

Great to be here.

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. [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. [Operator Instructions]

Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations, on our business and operations.

These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.glaukos.com.

Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available in the Investor Relations section of our website for a reconciliation of these measures to the most directly comparable GAAP financial measure.

With that, I will 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.

Today, 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 a sustained growth acceleration in our business, driven by growing iDose TR adoption and utilization, along with our broader Interventional Glaucoma, or IG, initiatives globally. Within our U.S. 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 3 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 MIGS forward as the 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 for iStent infinite were very high during the meeting, reaffirming our view that EU MDR certification for our 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.

And finally, 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 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 [indiscernible].

Beyond that, we continue to advance a 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 maintain 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 a 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 2 prospective multicenter, double-masked Phase III pivotal trials that randomized a total of over 400 patients. Both trials successfully achieved their prespecified 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 sales force 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 have helped preserve visions 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 over the past 6 years, the unfortunate reality is that the access to proper care still remains far too limited, evidenced by the fact that we are still only treating about 10,000 patients annually with Photrexa today.

We estimate fewer than 1 in 5 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 elect 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 second time. 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: 1, lack of awareness and under diagnosis; 2, misdiagnosis and a focus on managing symptoms rather than proactively treating the underlying disease; and 3, 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 underdiagnosed and under-treatment 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 the 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 covered 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 are also deeply grateful to the clinical investigators and participants in 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 remains 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 we hope you 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 an exceptional value to patients, providers and the health care 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 analysis, 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 is 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 in 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 stage 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 will 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 co-pay 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 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 MIGS 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] Your first question comes from the line of Tom Stephan from Stifel.

I'll start off with iDose, and I wanted 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 sort of what your views are on the potential outcomes here.

Sure. Tom, it's Joe. I'll start off. And as always, Tom can also add in any comments at the end here. I'd say that from a rationale perspective and maybe how we're viewing it from a macro standpoint is that we see this really as a step in the process of educating these MACs and really educating them all on, #1, the significant unmet need that iDose meets for glaucoma patients, as you all know; 2 and as importantly, the robust FDA and peer-reviewed Level 1 data evidence that supports its proper utilization in the care continuum; and 3, ultimately really establishing the patient access that our glaucoma patients and physicians deserve around the product.

And 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. But 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 in at least 15 peer-reviewed publications, all that support and supported the FDA approval and the label that is, when you look at it, largely consistent with other pharmaceutical therapies in glaucoma.

So I think there's 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 the glaucoma patients here in the United States. So from that standpoint, we look forward to having that engagement and from them moving forward from a more educated basis to adjudicate the claims that come their way.

I'll just add, if I can, Joe, let's talk about some of the data that we already have in hand. So we've got 2 Phase III clinical trials, which you're all aware of, to establish the NDA submission and PMA approval of over 1,000 patients that are validating the use of iDose in standalone glaucoma patients. And then 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 pretreatment means.

We're conducting a prospective Level 1 study of iDose in combination with cataract versus cataract surgery alone. And we're also -- I think we were smart in also 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 conscribed and used under the current label that we provided.

Really appreciate that color. And then my follow-up is just on Epioxa and congrats on approval. Maybe a quick 2-parter. Can you just elaborate a bit on sort of 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?

Sure. Thanks, Tom. I think as it relates to the coverage and continued access to -- or gaining access for Epioxa patients, I think like everything else, that's a process 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 mentioned, the -- 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 be able to get 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 heard Tom mention some of these, but as 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 of that customers updating their contracts and generally, what I'll call is the slow and methodical process of establishing proper payer coverage and patient access for any rare disease, Epioxa will be 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 before we jog as we exit 2026.

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

Congrats on the great quarter. Maybe just kind of piggybacking [Technical Difficulty] the preliminary [Technical Difficulty] $600 million to $620 million for next year. That's a little bit above consensus at the midpoint and companies don't typically guide [Technical Difficulty] to do so. And as we think about the different components of that revenue range [Technical Difficulty] versus [Technical Difficulty] each of those segments. And 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, but aren't throughout that. I believe that you were asking for more context or color around the guidance range of 2026 of $600 million to $620 million and probably pushing a bit for a bit more granularity around the constituent parts of that. So assuming that I'm correct on that, I'll give you that answer which is good.

I think as I mentioned before, we felt like 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 is 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 is we feel confident in this early range and that a variety of paths through each of the franchises, if you will, U.S. 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 color around the iDose performance in the quarter, really good number there. Did [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 kind of which patients are getting iDose? Is this being done totally in the standalone setting? How much is coming from combination with cataract? How much is with a second mg?

Yes. Again, you're breaking out a little bit, but I think the question was largely around the iDose 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've 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 MedVantage utilization was a part of that. We saw new doctors picking up. We saw some who had maybe been a part of early trying and trialing now having maybe received their payments from 2024 starting to get back into providing high dose of the therapeutic option for their patients.

So it was really high quality. And I would say in terms of some of the 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, of Noridian, Novitas and First Coast.

So the growth balance was across the board, but the weighting was still towards 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 kind of 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 the combination with anything else, including as a part of a combination cataract procedure, is not something that we know when it goes out the door. Anecdotally, we know that 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 meeting the surgeon many times 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 the anecdotally of the overall mix, but it's largely in those regions where you have more established reimbursement than some of the other MACs where we're a little bit further behind.

Your next question comes from the line of Larry Biegelsen from Wells Fargo.

I guess, Joe, I wanted to start with Epioxa. What -- for those of us who have followed this a long time, know that when Photrexa -- 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 have one follow-up.

Sure. I'll start, Larry, and then others can comment as we go forward here. But for Epioxa, I think that first and foremost, and obviously the reset moment as you heard Tom talk about, this is an education process. Just like you'll recall, to your point, having been around with Avedro back in the day as they first reimbursement around keratoconus itself with 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 a uber-rare disease and pretty consistent with the type of treatment numbers as we understand it from indications or for other rare disease therapies in ophthalmology such as oxybate or 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 cost of the wholesale acquisition cost that Tom talked about, I think you're going to find that it compares pretty 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 talk about.

This is a different way of looking at the situation, but 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 your way 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 1 in every 5 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 we'll be hard at 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 deserve to get 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 '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.

Yes. Well, first, I think you have to do a blended average over time. I wouldn't do $78,500 in your long-term models. Obviously, we are a member of the Medicaid rebate program. We do provide that discounting for that patient population as a part of this. So when you think about a blended WACC, and we'll talk more about that as we actually get into making that drug available.

I'm certainly -- I think we went far enough in terms of providing our preliminary views on 2026. I'm not going to go that far as you'd like 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 our 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.

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

So maybe for you, Joe, a little bit on iDose. In the absence of the CAC meeting and kind of 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 kind of in the context of 2026. And do we think of iDose following the similar progression in kind of a linear fashion through 2026 and beyond? Is there a point at which you see an inflection occurring where kind of the scales tip, if you will? I'm wondering if you could kind of speak to that and kind of how you guys think internally about the progression and adoption of iDose over time?

Yes, 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 assess 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 the Medicare regions that represent about 50% of covered lives. So I think as we go forward, the CAC meetings, all the other education efforts that we're doing with these individual MACs to establish proper and appropriate fee coverage moving forward, that simply getting the Medicare arena to the right place of loan continues to leave us optimistic around what that means for 2026 and certainly beyond.

And that's before, and I think you're touching on it a little bit, you start to think about that broader utilization that we're starting to see in 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 or other areas.

So as we make our way through and more and more folks is focused simply on treating the disease and less on the insurance type, I think that's when they're 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 bit more stability, if you will, around that broader, call it, 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 will be an inflection, but I think it's what underpins our bullish optimism of what iDose will mean for Glaukos, for our customers and for our patients, not just for 2026, but for the next decade as we continue to change the standard of care.

Just related to the CAC meeting, the agenda was posted. The questions were posted a couple of days ago. I don't want to leave the witness here, Joe, and I don't know if you're going to comment to this, but I'm going to try anyway. And 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 kind of evidence that the totality of the data and that there is a misalignment in terms of understanding? Or do you feel like it's purely -- this is coming in with maybe a little more purpose given how fast this has kind of bubbled up, if you will, relative to the historical efforts we've seen in legacy MIGS. I'm just I'm trying to still understand kind of why this has happened as quickly as it did so early in the launch cycle of iDose.

Yes. 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. I think if you take a step back, Ryan, and you think about how much enthusiasm there is in the clinical community around iDose and what it means for their patients and the outcomes they're seeing, all the things that 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 that they're getting properly paid and the coverage associated with it.

And 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 makes sense in the context of the way we or 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 that where they're trying to understand the overall fit of iDose into the treatment paradigm, and they want to ask that question of a group of 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.

Your next question comes from Allen Gong from 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 prophy schedule yet? Will that accelerate that process? Or will you still have to wait to get on prophy?

Well, I think coverage and payment are 2 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 3 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 price. So I think that process continues to unfold.

What you're talking about in the 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 in 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 of that comes Medicare Advantage coverage policies as well. And so you do have to -- oftentimes, the I'll call it, 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. And so you can argue that there's certainly some opportunity associated with that should LCD ultimately emerge from this line of work.

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

I wanted just to come back to the market development and education efforts around Epioxa. So a lot of what you're laying out sounds like it actually more 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 sort of rare disease categories and I'm thinking more on the traditional pharmaceutical and biotech categories, there is a lot of investment around payer education and physician education. But maybe you could help us just give a little bit more flavor of some of the specifics around the investments that you're making and how we see those show up and over what time period?

Yes, David, it's Joe. So I think counter a little bit, I'll start macro and then I'll give a little more micro for your question. But from a macro perspective, what you think of in terms of large population-based patient education initiatives are the legacy, I'll call it, direct-to-patient advertising commercials that you see on broadband television during various sporting events or whatever it may be that is there to help make sure there's awareness being driven.

What's different with rare disease is it's much more of a needle in a haystack exercise. And so that effort -- those efforts around awareness and detection mirror that of that broader disease state or 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 when 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 and 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 the early things that could be signs of keratoconus to make sure that they're getting proper access to the detection and the various things that are necessary to at least 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 obviously an important part of any education thing. There's a lot in terms of what you do with your field organizations. And just to put that in context a little more micro level, David, today, the majority or 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 these patients first present themselves most often with visual acuity issues. But there are 50,000 optometrists and numerous other opticians that serve a little bit as the primary care physician.

So how you get to driving education awareness in that community, both digitally as well as with your sales force 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 in any time you have a needle-in-a-haystack patient, and again you heard Tom reference in the prepared remarks, but these patients -- if you think about the number of insurance plans that are out there and when you're really treating 10,000 patients, every single time one of those patients present themselves asking for access to Photrexa, not 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. There's 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 qualify, provide them with assistance as they go through are all major, major investments for us.

Now the last thing you asked, I think, is how that turns on. We're going to have -- and Alex can comment on this in the context of the broader P&L. We're going to have some of this happens right away. Some of it certainly picks up steam as we make our way into 2026 from 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.

Your next question comes from the line of Richard Newitter from Truist.

I might have missed it, but I just want to make sure I'm understanding the components of your updated '25 guidance and kind of 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 as to what we should be modeling for that business and what the trend should be in the kind of the iDose sequential trend?

Yes, Richard, happy to. I haven't addressed it yet, obviously, other than us announcing the updated guidance range of $490 million to $495 million. I think first putting in context, the performance thus far in 2025 and obviously highlighted with the results in the third quarter has really continued to exceed our internal forecast. And based upon that, we did raise 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 face 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 U.S. 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.

As you think about 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 that I think a little bit of it -- 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 U.S. Glaucoma side, we expect growth in the mid-40% range year-over-year in the fourth quarter as our non-iDose business continues -- its stents and everything else continues to stabilize. We would expect a low single-digit decline in the fourth quarter. So continue on that progress back to, I'll call it, a more stabilized situation post 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 that it's tempered a little bit sequentially versus the current trends, just given many surgeons have pretty full cataract schedules throughout the remainder of the year. I think it's a little bit early to start seeing the benefit from the NGS, I call it, 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.

And then maybe just, well, actually 2 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 kind of there, just so we can benchmark ourselves as we put preliminary numbers out there? And then the second follow-up, just on the trial time lines that you were talking about for combo cataract and MIGS plus iDose. Can you just give us a sense as to when those that are going to read out and the ones that have read out, where they are?

So I'll start, and then I'll 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 the consensus and 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 in assessing. And so I want to make sure that we talk about that in the same context at the same time as we talk about our expectations for Epioxa and the Corneal franchise throughout the year. What I had said based on the earlier question was if you think about the third quarter results of $40 million, we're at this point already kind of on a $160 million run rate based again largely on the continued progress within the 3 MACs that have established professional fee coverages entering the quarter, that being Novitas, Noridian 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 set or update our guidance for the full year when we get on the fourth quarter call.

Tom?

Yes, I'd be happy to answer the questions. We're looking at 2 pretty major Level 1 Phase IV clinical studies, and that's to 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.

So 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 will probably prepare the investment community for a 2027 timeline, which would give us the ability to have really 6 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, be able to look at these patients at earlier time points. Typically, 3 months would be the earliest that I'd be able to publish. So I'd set your parameters to look at a late 2026 to '27 with some very, very important follow-up clinical data for the use of iDose.

[Operator Instructions] Your next question comes from the line of Mason Carrico from 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 a book-and-bill strategy with clinics? And if so, how much of your volumes rely on that?

Yes, Mason, with Photrexa today, we offer both buy-and-bill acquisition options as well as 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 increasing material portion of the overall acquisition mix.

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

Yes, just another one on Epioxa. So 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, kind of what's the strategy there for either upgrading or trading out the current installed base?

Yes, David, I'll start with -- on the capital equipment and establishing the site of care network. Epioxa does require a new piece of capital equipment and O2 system that will be made available. We are already now with the approval in hand, hard at work out in -- with customers to establish that changeover. As you might expect in 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 equipment 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. And 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 disclosed here today in terms of the therapy, its benefit to patients, engaging with those in the medical community to make sure that 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, and you heard Tom mention them 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 bit premature for us to establish benchmarks in terms of payer coverage expectations. I'm optimistic that when we engage in the conversation around the benefits that we're providing to the patients that are at the end of this that we'll move the needle as aggressive as we can with those payers to get that access going throughout the course of 2026.

Your next question comes from the line of Joanne Wuensch from Citibank.

I have so 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 that for iDose? I'm just trying to piece it all together because at that ASP, those numbers can ramp really fast.

Yes. Thanks, Joanne. And so, 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 as what I said earlier that we're confident in that range, and we're confident there's 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 raised 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 the J-code, 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.

Your next question comes from the line of Michael Sarcone with 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 3 years, call it 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 "lower-hanging fruit" for that portion of community could drive the mix a little bit closer to or with a little bit more oriented towards the combo cataract setting. But certainly, as you get out into the 3-, 5- and 10-year time horizon, the vast, vast majority of it is interventional in nature and standalone being the key driver of our long-term opportunity.

Your next question comes from the line of Anthony Petrone from Mizuho Group.

Maybe one on the follow-up discussion with FDA on iDose reapplications. You mentioned in the prepared comments and the 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?

Yes, 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 then to get an answer to our appeal to be able to have readministration of the iDose device. As I've said many, many times before, we take a [indiscernible] approach to this. The reason we have iDose TREX 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 implantations of iDose come to term in 3-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 not to move forward with the readministration.

As it relates to the -- I think your second part of your 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 is an FDA-approved pharmaceutical with a label and its end use that's pretty similar to topical PGAs and other glaucoma medications. That's different than a medical device.

And I say that because what matters in an FDA-approved pharmaceutical is what is the contraindications that are within it. And the -- 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 medication for that matter. Today, iDose TR is approved with an open label that's very similar to topical PGAs. If indeed, as Tom is talking about, we were to achieve that the PDUFA date around reimplantation, that would bring that to remove or at least modify that contraindication and certainly help us in terms of opening up that part of the market.

Your next question comes from the line of Danielle Antalffy from UBS.

I was at the AAO meeting a few weeks ago and I felt like the takeaway from [Technical Difficulty] there looking for specific things, right, but was a focus on building out standalone MIGS practices. I attended a lunch session that was focused on that. And I'm just 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 total MIGS patient population here. Where you see standalone MIGS going over the next 3 to 5 years? And what are the sort of logistical things with practices that you think need to happen in order to enable continued growth in that market?

Yes, Danielle, I think it's a great question and a good one here as we are wrapping up this conversation. I mean everything that we've been doing for a couple of years now and certainly as we are moving forward is around driving that standard of care towards 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 and rounds at AAO, that you heard that same thing.

Any time 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 this 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 a part of their toolkit, if you will, in trying to tackle this sight-threatening disease, it's encouraging to hear that they continue to sort of move forward.

But on the logistical side, it does change. 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 want to treat them as a surgeon or a physician.

So each one of these things play themselves out. And none of them are overnight success stories. Each one of the things you make incremental progress every day, every week, every month and every year. And I think it's why when we look out 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 head down and keep executing against that.

And if we do that, you're talking about a market opportunity, as you heard me say many times, there are 21 million or 22 million eyes in the United States with ocular hypertension or glaucoma. 12 million 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 0.5 million eyes.

So when we look at this over a prolonged period of time, we expect the vast majority of procedures irrespective of the tool to be done in that standalone and interventional glaucoma market, purely 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.