Glaukos Corporation

Hello and welcome to Glaucus 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.glaucus.com. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. This call is being recorded and an archived replay will be available online in the investor relations section at www.glaucus.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 Glaucus 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, title 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. Please note this is a change versus our previous calls. 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 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 and others. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor section of our website at www.glaucos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaucos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables on earnings press release available in the investor relations section of our website for a reconciliation of these measures for their most directly comparable GAAP financial measure. With that, I will turn the call over to Glockos Chairman and CEO, Tom Burns.

Okay, thank you, Chris. Good afternoon, and thank you all for joining us today. Today, Glockos 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 to 700 million, an increase of 60 to 65 million over our prior guidance of 620 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 two transformational growth drivers. including the further advancement of the interventional glaucoma treatment paradigm with iDoseTR 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 long 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 results 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 IDOS-TR, which generated sales of approximately 74 million in the second quarter. IDOS-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 review publications, complimented by a broad portfolio of active phase four 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 maintained 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, five of the seven Medicare administrative contractors issued proposed local coverage determinations for IDOS-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 IDOS-TR is delivering to patients. We continue to believe that the strength of IDOS-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 NAICS forward as a 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 NDR 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-planting 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 a broad reaching site of care network. Our acquired O2N systems are already actively deployed across locations serving roughly 85% of the US 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 for policy coverage for Epioxa. With access pathways now established for more than 125 million covered commercial lives in the United States. including with the five largest payers reflecting encouraging initial receptivity of Epiox'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 U.S. payers over time. The on-market access, we're proud to lead the way once again in forging a new path for interventional care at CONUS 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 abroad and differentiate clinical pipeline across our five novel therapeutic platforms, encompassing 13 publicly-disposed programs and additional undisclosed assets supported by a robust portfolio of active clinical and phase four studies. Within our IDOS platform, we are advancing a phase 2B3 clinical program for IDOS T-Rex, our next generation IDOS therapy and patient follow up in a phase 3B study for IDOS Trio with a targeted FDA approval by the end of 2027. We also continue to advance various additional phase four 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 three 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 ISEN infinite and mild to moderate glaucoma patients and recently completed patient enrollment in our 510k pivotal study for the presser flow microshot. Within our ILLUTION platform, we recently completed patient enrollment in a phase two 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're advancing a first in human clinical development program for GLK401, 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 Globcos, 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 Eidos 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.

We will now begin the question and answer session. Please limit yourself to one question. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Tom Stephen with Stifel. Your line is open. Please go ahead.

Great. Hey guys, congrats on the nice quarter here. Maybe on corneal health, nice start to the epioxal 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, know the earnings summary, I think mentions some transient headwinds in 3Q amidst the transition to Epioxa, but any more color on the cadence would be great. Congrats again.

Yeah, thanks, Tom. Happy to jump in there. Obviously, we were I'm very encouraged by the contribution of Epiox and 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 you heard Tom mention, obviously, our primary focus today remains on those building blocks. that we think really set up at Voxa 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 Jacob. We've talked about that for some time. So you enter the third quarter having sunset largely Botrexa while launching, if you will, Epioxa in this permanent JCODE 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 epioxet as we transition that way, you know, throughout the third quarter, and certainly in the fourth. I think as we get into the fourth quarter, we have a lot more conviction that some of those JCO translation or transition related issues should start to get behind us and we should start to see that uptick as we think our way, you know, making our way through the fourth quarter and in the beginning of next year. So I think we're gonna 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, you know, really our overall corneal health franchise. And we started off this year saying we were confident we would still grow. And then we ultimately, I think, you know, upgraded that to high single digits. And now I think we're confident saying that for the overall year, corneal health should now be able to grow, you know, call it 20% plus or minus on a year-over-year basis. Just again, based on that strong Q2 performance and then the growing epiosic contributor contributions as we make our way through the remainder of the year.

Got it. Congrats again.

Your next question from the line of Adam Mader of Piper Sandler. Adam, your line is now open.

Hey, good afternoon. Thank you for taking the questions and great quarter. I guess just one for me. I'm going to keep pulling on the modeling thread question. You just talked about expectations for the cornea 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 IDO's contribution versus the stent business versus, you know, OUS and cornea health for the second half. Thanks so much.

Yeah, I'm happy to do that. You know, as both you and Tom alluded, we obviously very pleased with the strong second quarter and and you know really each of our franchises exceeded expectations and and so as a result we were we were happy to be able to raise guidance in line with what you heard Tom mentioned earlier to the 680 to 700 million mark. If you think about your your kind of models by franchise and I think it requires adjustments across all the franchises given that that outperformance First on international glaucoma, I would say we've increased our expectations. They are now where we expect to achieve low to mid-teens year-over-year growth for the overall year. If 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. 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 and some reimbursement headwinds that have emerged in Germany and Switzerland. But, you know, offset that by continued growth of presser flow and infinite and really our overall, you know, interventional Valcoma market developments abroad. So I think we're pleased to be able to increase our expectations there at a 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, attempts to factor in, especially in the third quarter, the impact from sunsetting Photrexa and shifting to the permanent JCO 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 US glaucoma side, we now expect full year growth of right around 50% plus or minus for that business. and that's really driven by two 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 Eidos TR, which, you know, I think when you do all the math, you're going to land somewhere in that, I'll call it 275 to 280 range for Eidos in 2026.

Very helpful. Thank you.

Your next question from the line of Larry Bagelson of Wells Fargo. Larry, your line is now open. Please go ahead.

All right. Thanks for taking the question. And yeah, pretty impressive quarter here, guys. So I'll be the first to ask about the IDOS LCD. So, you know, since the open meetings for the IDOS LCD, how has 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 IDOS over the next few years? Thank you.

Yeah, thanks, Larry. I mean, to your point, clearly a lot's transpired on this front, you know, between the draft LCDs that came out in May, the open meetings in June, and the formal submissions in early July, and and really I think the way we always had conviction as you can imagine around the evidence associated with Eidos in a multitude of settings and use cases and certainly perhaps most importantly the study that supported the approval of Eidos and all the evidence and that generate 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 Eidos. At this point, you know, 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. You know, as I think about in the context of, you know, 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 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 so-called 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 Eidos 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 Eidos today I think shortens the putt, 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 idos 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 to 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 a final proposed LCV. All right. Thank you.

Your next question from the line of Ryan Zimmerman with BTIG. Ryan, your line is now open. Please go ahead.

Thanks for taking our questions, and let me echo my congrats. It's really impressive. Maybe turning back to Apioxa for a minute, Joe, you know you talked about some of the patient co-pay dynamics that you're standing up and and I'm wondering if you could elaborate on kind of how you think about the gross to net pricing for Apioxa over time and and the second component of my question I'll sneak in a two-parter into one question just to keep to Chris's rules but when you think about the O2 placements and you know the 85% of the user base what are you seeing are you seeing new users take over these systems are you seeing Thanks for taking the questions. Of course.

I'll pretend like it was one question, Ryan, so that I don't get in trouble with Chris. First, as it relates to the Epioxa kind of growth to net dynamics, obviously that's something that we'll be watching. Alex will be watching alongside of us here as we get a bit more maturity in the market launch of Epioxa. 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 the 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, You know, we made a lot more progress during the quarter and we were already well ahead of our expectations. I think at this stage to be able to say you've got systems deployed is sort of 85% of the US 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 JCO 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. We'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-focused standpoint provided the optimum care in terms of their treatment times, their commitment to it, the education with the optometrists in their 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. 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. 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 Epiof solution like Botrex. Thank you.

Your next question from the line of Alan Gong with JP Morgan. Alan, your line is now open. Please go ahead.

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

Hey, Alan, 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, you know, cash generation in the quarter that we saw. And again, you know, like we've said to investors in the past, given our company's close margin profile, there's certainly a clear line of sight that we have today towards cloud proceeding 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 two 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 two 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.

Thanks, I'll just leave it at that.

Your next question from the line of security. Richard, your line is now open. Please go ahead.

Hi, thanks for taking the questions and congrats on the quarter. I guess I just want to ask very quick ones on Eidos and one on Epioxa. I guess on Eidos, 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 backdrop of 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? Thank you.

Yeah, thanks, Richard. First, on the IDOS front, I thought there was no, that I'm aware of, you know, LCD related, you know, pull forward dynamics in IDOS. I mean, most of the surgeons you talk to, their schedules are pushed out well beyond even that timeframe 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've had meaningful growth from the beginning, but in this quarter, we really saw both an acceleration across the various mags. 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 IDOS 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, 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 seasonal down quarter in terms of ophthalmology procedures in the third year. 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 60K 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. Thank you.

Your next question from the line of Joanne Wiench with Citi. Joanne, your line is now open. Please go ahead.

Thank you so much and good evening. 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% growth 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?

Hey, Joanne, it's Alex. Thanks for the question. And yeah, 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, you know, call it you know 90 basis points from last quarter and you know that accretion was driven as you might expect from the growing contributions of eidos and epioxa and the overall revenue mix and you you were asking about looking ahead uh you know we would continue to expect modest gross margin accretion over the remainder of the year uh and particularly in the fourth quarter as the eidos and epioxa sales you know continue to become a greater share of our revenue mix Now, that all said, you know, 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 margins?

Yep, on operating expenses, yep. Nope, that's exactly right. We, you know, we were 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 growing 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 toward a cash flow break even stance. And those all kind of fold together and triangulate.

Excellent. Thank you so much.

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

Thank you again. Your next question from the line of Mason Carrico with Stevens. Mason, your line is now open. Please go ahead.

Hey guys, appreciate the questions here. Going back to the guide, you called out IDOS revenue in the $275 to $285 million range this year. That seems to imply a 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?

Yeah, 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, you know, 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 two 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 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.

Got it. Thank you.

Your next question from the line of David Saxon with Needham and Company. David, your line is now open. Please go ahead.

Great. Good afternoon. Thanks for taking my question and obviously a really strong quarter here. So I wanted to ask my question on EPIOXA and, you know, would love if you could talk about the cadence of prior off 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 does the the backlog of eyes looking in the portal, you know, 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. Thanks so much.

Yeah, 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 for the latter part of the quarter. And that stands to reason with an FDA approval that was as we exited 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 gears 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 then on July 1st obviously you have it's not a full reset if you will but there's a partial reset there around making sure those patients are getting access in the contracts and the 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 that's why we we've 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 mention 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 epioxide 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'll be our focus here. But the leading indicators are strong in terms of the number of patients that our providers are seeking access to epiox as a therapy. Great.

Thanks so much for that, Joe.

Your next question from the line of Stephen Lichtman with William Blair. Stephen, your line is now open. Please go ahead.

Thank you. Hi, guys, and congratulations. I'm wondering on your Epioxa customers how they're viewing the specialty pharmacy option versus By and Bill, are we seeing most go to specialty pharmacy initially? How quickly are they getting confidence that they're shifting to By and Bill? Because obviously that's another driver over the medium term. Thanks.

Yeah, absolutely. So that answer that question has very much to do with which side of care you're talking about. So there are clearly those institutions and groups who have the experience and are much more comfortable out of the gate with the buy and build pathway. And you see them pretty much even in these 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. It's certainly, again, in these 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 build pathway. But it's a little early, you know, again, thinking about we 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'll be a part of the journey here over the next several years, but one we're prepared to support.

Thanks, Joe.

Your next question from the line of Anthony Patron with Mizuho Group. Anthony, your line is now open. Please go ahead.

Thanks and congrats here 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? Thanks.

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 Glaucos 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 scleral lens, that's really not a competitive solution. These patients often will have scleral lens even after therapy. The point is you've stabilized 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 disease and put scleral lens where it should be which is you know post-operatively a part of continuing that vision as you move forward after a cross-linked procedure. So I think that epioxa helps us in that broader initiative in terms of solidifying cross-linking as the therapy of choice. And I think ultimately, we provide the investment to meaningfully change. We've talked before about the 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 at 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's 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 it now a third generation customized topographically guided eyelid therapy that's going to begin 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 and 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. 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. Thank you.

Your next question from the line of Yi Chen with HC Wainwright. Yi Chen, your line is now open. Please go ahead.

Yi, are you there? Maybe I'm you.

Can you hear me?

Yeah.

Hi, this is Katie on for Yi. Just real quick on looking at re-administration and TREX. Is what you're seeing what you kind of expected from early implant re-implantation 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 re-administration, 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 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 I-dose wears off. And if you think about it in the context of I-dose T-Rex, you know, in the future and the approvals there, I think that's only additive in the context of that overall algorithm for getting those patients therapy both initially as well as during the re-administration procedure.

Perfect. Thank you. 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 Qualcos. Goodbye.

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