Glaukos Corporation (GKOS) Earnings Call Transcript & Summary

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.