Glaukos Corporation

If you would like to ask a question during that time, press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star followed by the number one. This call is being recorded and an archived replay will be made available online in the investor relations section of www.glycos.com. I will now turn today's call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

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 titled Quarterly Summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details key facts associated with the quarters statements or guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call. As such, for this call, we will make brief prepared remarks and transition into a question and answer session. To ensure ample time and opportunity to address everyone's questions, we request that you delimit 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, the efficacy of our current and future products, dependent 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. 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.globcos.com. Finally, please don't forget to turn today's call to 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 Cloud Coast's 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 list 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 Cloud Coast Chairman and CEO, Tom Burns.

Okay, thank you, Chris. Good afternoon, and thank you all for joining us. Today, Glocos reported record first quarter consolidated net sales of 106.7 million, 25% on a reported basis or 26% on a constant currency basis versus the year-ago quarter. We are also reaffirming our full year 2025 net sales guidance range of 475 to 485 million as we balance our first quarter outperformance while continuing to closely monitor the global macroeconomic environment and associated uncertainties. Our first quarter record results reflect the sustained growth acceleration in our business with strong performance driven by IDOS TR adoption and both our US and international glaucoma franchises overall. Our continued growth trajectory globally is the result of our ongoing efforts to pioneer and develop the interventional glaucoma or IG marketplace with new standalone therapies designed to slow disease progression and reduce drug burden for the benefit of physicians and patients. These efforts were on full display at the AGS conference in February, and more recently at the ASCRS annual meeting last weekend, where the interest and excitement levels for interventional glaucoma and our technologies were high. While we remain in the early stages of these IG efforts, we are encouraged with the increasing levels of clinical interest for this paradigm-changing evolution. Within our U.S. glaucoma franchise, we delivered record first quarter net sales of 59.1 million on strong year-over-year growth of 41%, driven by growing contributions from IDOS-TR, a first-of-its-kind intracameral procedural pharmaceutical, that was designed to continuously deliver glaucoma drug therapy for up to three years. Importantly, clinical outcomes and product feedback from a growing number of cases and trained surgeons continue to be very positive and reaffirms our view that with the launch of IDOS-TR, we are pioneering a brand new therapeutic category that has the potential to reshape glaucoma management as we know it today. Operationally, our teams continue to make great progress in the execution of our detailed launch plans for IDOS-TR, including first, growing the universe of trained surgeons and accounts. Second, expanding utilization of the installed active surgeon base. Third, broadening and streamlining market access among MACs, commercial and Medicare Advantage payers. Fourth, expanding the robust body of clinical evidence. And fifth, accelerating and marketing investments increase patient awareness and education. Overall, while we remain in the early 80s, I couldn't be more pleased with the strong foundation we built to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension. Shifting to our U.S. business as anticipated, the five MAC LCDs implemented in the fourth quarter of 2024 continue to cause some transient turbulence in the market during the first quarter as surgeons navigate restrictions when using two MACE surgical devices in the same procedure. We expect this MACE market headwind will continue over the course of 2025 as providers continue to navigate the impacts associated with these LCDs until an anniversary later this year. Moving on, our interventional Glaucoma franchise also delivered record net sales of $29 million on a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis. The strong growth was once again broad-based as we continued to scale our international infrastructure and execute our plans to drive makes forward as a standard of care in each region and major market in the world. We remain in the early stages of expanding our IG and product portfolio initiatives globally ahead of anticipated new product approvals and expanding market access in the years to come. As previously discussed, we expect the trialing of new competitive products in some of our major international markets may become an increasing headwind as we progress through 2025. And finally, our Corneo Health franchise delivered net sales of 18.5 million including Fortrexa then sales of $15.4 million. As discussed throughout 2024, our first quarter results reflect the continued impact of Fortrexa realized revenues as a result of our entry as a company into the Medicare Drug Rebate Program, or NDRP. Shifting gears to our corneal health pipeline, during the first quarter, we announced FDA acceptance for review of the previously submitted NDA for epioxa. our next-generation corneal cross-linking eye link therapy for the treatment of keratoconus, a rarely diagnosed sight and driving disease. This important milestone brings us one step closer in being able to provide keratoconus patients in the Epsom community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. We look forward to working closely with the FDA and their pending review process as we progress toward the agency's established PDUFA date of October 20, 2025. Alongside this, our teams continue to make nice progress with the preparation and planning of the EPIOXA commercial launch targeted for next year. It is worth reminding investors that an Epioxa approval also provides us with the opportunity to launch this pharmaceutical therapy supported by the right long-term pillars to optimize patient access, a persistent and at times frustrating challenge for us historically with Latrexan. We continue to believe that Epioxa, which is designed to preserve the corneal epithelium, streamline procedure times, improve patient comfort, and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus. Beyond Epioxa, we're also pleased to share we recently commenced a 510K pivotal study under FDA ID for the Pressor Flow Microshunt, an ab external system designed to help drain excess fluid from the eye and reduce intraocular pressure in refractory glaucoma patients. Our commercialization efforts of pressure flow in Canada, Australia, and several Latin American countries have reaffirmed the strong appetite within the global ophthalmic community for this technology as a more elegant, better tolerated, and external alternative to conventional filtration surgeries for late-stage glaucoma management. Additionally, we continue to advance several other important clinical trials, including one PMA pivotal trial for i7 infinite mild to moderate glaucoma patients. Two, phase two trials for our ILIG third generation therapy. Three, a first in human clinical development for GLK401, our intravitreal multi-kinase inhibitor retinal program in wet AMD patients, where we now also have an open US FDA INDE. And four, a Phase 2b3 clinical program for I-Dose T-Rex, our next generation I-Dose therapy. Finally, we remain on track to file a U.S. FDA IND to commence clinical studies for I-Lution, Devon X blood for our insulator this year. As you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. At the same time, as we consistently discuss, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based investments in our capital position now and in the future. To that end, we ended the first quarter of 2025 in a strong capital position with cash and equivalents of more than $303 million and no debt. This has allowed us to continue to be active on the business development front with a focus on transactions that support our existing organic growth initiatives. One such example of this is our recently announced expanded collaboration with RadiusXR and TopCon Healthcare that enables us to accelerate our global efforts to bring the tools and software solutions needed to democratize the diagnosis of glaucoma and in turn create more efficient care networks for patients afflicted with this lifelong disease. Finally, given the ongoing conversations around tariff and geopolitical issues, we wanted to highlight that we manufacture and source our products primarily within the United States. And as such, we expect minimal direct exposure to the most recently implemented tariff related policies. In conclusion, I am very pleased with a record quarter and strong momentum in our business as we continue to successfully advance our mission to truly transform vision by pioneering novel, dropless platforms that can meaningfully advance standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases. So with that, I'll open the call for questions. Operator.

At this time, if you would like to ask a question, press star followed by the number one on your telephone keypad. If your question has been answered and you would like to remove yourself from the queue, press star followed by the number one. Your first question is from the line of Tom Stevens with Stiefels.

Great. Hey, guys. Thanks for taking the questions. I guess first to start off, would you be able to provide U.S. stent growth in the quarter and as a tack on to that, Joe or Tom, maybe if you can talk more about what you're seeing in terms of how doctors are reacting from a share standpoint to the LCD so far this year and expectations looking ahead for U.S. mix. Thanks.

Hi, Tom. It's Joe. I'll start off, and then Tom can add any additional color that he might have for conversations he had, including this past weekend at ASCRS. You know, in the first quarter, we really saw The U.S. glaucoma business, you've seen the reported overall, you know, 40-plus percent year-over-year growth and the 5% sequential growth. And, you know, as it might be expected, that was entirely driven by the expansion of IDOS, TR, and offset by the impact of these LCD restrictions. They were modestly more pronounced than expected on our stent franchise. And in total, we saw a mid-single-digit decline year-over-year. So we're going to continue to probably forecast that for the foreseeable future here as we continue to navigate the potential impact of those LCD restrictions on our customers. You know it's somewhat uniquely challenging for us to forecast given You know, we estimate that the LCD changes remove 10% to 15% of the MIGS volume, if you will, in 2025 when compared to 2024. But for us, that's also somewhat offset by growing standalone utilization of ISA and Infinite and confounded, obviously, by the prioritization elevated associated with IDOS-TR. So, you know, from a macro standpoint, despite the 10% to 15%, you know, call it headwind in the combo cataract MIGS, Our sense is that we're holding our own, and the fact that we've experienced the mid single-digit decline in the first quarter is probably a relative positive in the context of the overall market dynamics throughout that quarter. As it relates to doctors, I think it's very specific to their own decisions and algorithms. and how they make those selections. Obviously, they're disappointed by the fact that the clinical decision-making has been taken out of their hands and being determined by an insurer, in this case, a medical director or a MAP, but they're navigating that, and perhaps they'll be focused more on a serial approach to the glaucoma care versus trying to do it combinatorially in a single procedure.

That makes sense. Really helpful. And then my follow-up to Eidos. I wanted to ask about Noridian specifically. It's been the most advanced MAC in terms of reimbursement. I think exiting last year was the only one with kind of streamlined J-code reimbursement and a professional fee on the fee schedule. So, Joe or Tom, have you seen or are you seeing any sort of inflection or acceleration in Meridian, you know, again, with reimbursement in a solid place. And then is it fair to view Meridian maybe as sort of an analog for when the rest of the MACs come up to speed? Thanks.

Yeah, Tom, I think clearly Noridian is the first case study that we can, you know, watch, assess, and then extrapolate in terms of what it can mean for the other MACs as they come online. And in fact, in some ways, what we've been seeing as of late in Novitas and the First Coast validates that assumption that the trend lines are somewhat consistent and the timelines associated with those trend lines are somewhat consistent. You know, sometimes as these milestones are knocked down or as the adjudication becomes more streamlined, it takes a little bit of time for that to translate both to the sales force, the customer, to their, you know, scheduling and staffing, as well as ultimately the procedures attached to it. But what we are seeing is continued solid and expanding growth. You know, you referenced Noridian specifically, given it was there first. And it shouldn't surprise you that, you know, despite being around 20% of the covered lives, its percentage of our overall, you know, IGUS contribution is something close to double that, given the dynamics at play there.

Your next question is from the line of Ryan Zimmerman with VTIG.

Hey. Excuse me. Good afternoon. Thanks for taking our question. You know, last quarter, Joe, you gave some commentary on kind of the components of guidance from a growth perspective. You know, you've beat now for the, you know, having the first quarter behind you. Guidance is staying the same. Maybe, you know, be curious to know kind of where you stand on some of those components within your guidance, obviously with an emphasis on kind of the STEM versus you know, Eidos franchises and contributions, or if those still hold, then remind us what those are as we think about guidance today.

Yeah, happy to do that, Ryan. Obviously, the first quarter was strong from a performance perspective with the 25% growth and certainly highlighted about 40% plus growth in the U.S. And as you think about, there are a fair number of, I'll call it, adjustments as we make our way through the year in terms of what comprises the overall guidance here. And so in no particular order, when you think about the corneal health business, We continue to dial in the impact of MDRP on this franchise. And at this point, I think we would probably guide you towards flat to low single-digit growth, clearly ahead of what we expect to be an exciting year in 2026 with the launch of FBOXA. That's a slight change as we dial in that. On the international glaucoma front, an encouraging start to 2025, continued strong performance around the globe. And so we probably have revised expectations there of, I'll call it high single digit to low double digit growth year over year. As we continue to kind of balance strong performance against the macro uncertainties and the backdrop that all companies are facing, and then in particular, obviously, competitive product launches and key markets and the laughing from that admitted French rebate agreement we talked about in 2024. And that then leads you to U.S. glaucoma, where, you know, I think we now expect that the LCD headwinds consistent with what we saw in the first quarter, and I'll call it the hydrous royalty expiration, to generate what I'll call a mid-single-digit decline for non-IDOS revenues in 2025. And when you put all that together, which I'm not expecting you necessarily to do on the fly, right, it's going to imply that we actually are modestly increasing our I-dose expectations for the remainder of 2025 versus what you probably had or most people had in their models coming into the call.

Yeah, no, that makes sense, Joe, and that all tracks with kind of the numbers that I'm getting to. And so the follow-up question to that is around the pacing of I-dose. and and you know we saw you uh this weekend at ascrs obviously a lot of focus there on idos how do you think about i mean there there is a pretty steep ramp implied on your idos expectations this year and and and some of that is from you know kind of max coming on board and so forth but just talk us through kind of what's underpinning those assumptions To get from where we think you did today, by my math, about $21 million and change this quarter to what arguably is almost double that by the fourth quarter.

Yeah, sure. In some ways also, as you know, Ryan, it's not significant change in volumes that drive those numbers. Obviously, it's a doubling in volume, but at the end that we're at right now, modest changes in your assumptions can drive those types of results in your model and your forecast. But, look, I think for us, you know, underlying where we sit today is obviously the month-to-month continued progress that we've been making including the progress we made from February into March and March into April sitting here today. If you think about what you're talking about is using the number you gave at 21 million, you're already at an $85 million run rate exiting the first quarter. And as you know, March was probably the largest contributor of that. So as we move forward, I think we've got good momentum to continue to achieve the EIDOS expectations that are underneath our guidance. And maybe more specifically, you know, just thinking about the Medicare, you know, fee-for-service patient population, you know, Tom asked about Noridian, but clearly we also are in the middle right now of turning on Novus Ops and First Coast. I would say that in recent weeks they've really joined the operating as expected group, which previously would have only had Noridian in it. And it took some time after the prophy schedule was established and published to reach that status. And at the same time, you know, Palmetto and WPS today largely appear to be paying the JCO correctly, and our attention and efforts in those MACs have started to shift to achieving more consistent professional fees. And even CGS and NGS have been showing early signs of JCO consistency. So I'm not quite ready to put them in alongside Palmetto and WPS. There are signs for optimism there. The translation of which in each one of those things does not necessarily mean that any one point in time, any one quarter, including the quarters where you're going to see some pop, but I do believe that overall it's a consistent upward progress on market access and in turn the commercial results that come downstream of that.

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

Good afternoon. Thanks for taking the question. I guess, Joe, on iDose, the question I have is, you know, have things played out according to your expectations on the reimbursement side? Has it taken longer? And, you know, obviously, I guess, are you still, you know, would you consider changing the price? I mean, obviously, the price came out higher than people expected. You know, how much of an impediment is that? And would you consider an LCD to unlock Medicare Advantage?

So a fair amount there, Larry. Let me first say that as it relates to IDOS and our internal expectations, both for 2024 as well as in the first quarter of 2025, the results have exceeded what our forecasting expectations were from an analytical perspective. As it relates to market access, you know, that's a harder one to answer because While it may have aligned with some ways with what we had forecasted that underpinned our models, you always want to move faster and you always want to see streamlined adjudication quicker, whether it's on the drug side or on the professional fee side, because you know downstream of that, you know, patients aren't getting access to your technology and your therapy that deserve it until you've got those things streamlined. So we've been operating as an organization with a high degree of urgency quartered and quartered out on working through the adjudication process. and getting this to a place where it's more streamlined like it is now in Meridian, Novitas, and First Coast. I think that it's a misconception to think that price is the element driving the pacing of these coverage and the streamlined education. It's a process that every company goes through when they have a newly established T-code or in this case T-code and J-code to drive the volumes that are required for these MACs to both understand the underlying procedure, quantify or value that, and then feel confident enough to put it in their systems as such. And so from our standpoint, I think maybe the only thing that impacted that from a price standpoint is that it's obviously a little bigger leap for the customers in the early days, but certainly well worth that squeeze, if you will, downstream as you get into the place like we are with both Meridian, Novitas, and First Coast today. I think as an LCD matter question, we've seen the downsides when others have pursued LCD dynamics in and around this. And so I don't know that's the first place we would go to try to drive more streamlined adjudication. Ultimately, the Medicare Advantage policies We have pretty significant coverage today along the similar lines of what Darista has as the other procedural pharmaceutical. And so we would expect it to go down that path moving forward here in a very similar way and continue to open up those access for those patients. I don't think we need an LCD to accomplish that.

All right. I'll leave it there. Thanks for taking the question, guys.

Your next question is from the line of Alan Gong with J.P. Morgan.

Thanks for the question. You know, kind of piggybacking off of the tariff commentary that you provided, you know, I think one of the concerns is that, you know, as we move into the back half of the year with kind of a pretty uncertain macro backdrop, which companies might be, you know, more or less exposed to an economic slowdown and potentially kind of like, you know, lower procedure volumes. So I guess just from your point of view, when we think about ISTENT, and idos if there is a economic slowdown, how exposed do you think you are to those kinds of dynamics?

Yeah, I think it's something we factored in in our decision to leave guidance where it's at. It may have been in some ways one of the more significant contributors to our decision to sit tight on guidance here at the beginning of the year. And it's hard, Alan, to point to a specific cause and effect when it comes to things like macroeconomic policy and the various places that can rear its ugly head. For us in general, ophthalmology, it follows the areas of healthcare that are a little bit more insulated, certainly the kind of procedures that are associated with glaucoma care where they're not elective as much in nature. Anytime you see pressure on the economy at large, you can see if rates rise and people are having a harder time getting access to lines of credits or, in general, running their business, you can have impact as surgery centers or customer offices or different things struggle to make their way through an economic downturn. And so, I think it behooves all of us to stay a little bit cautious around, you know, the next, you know, six, nine, 12 months as we play our way through the tariff situation, what it could mean for the economy overall.

Got it. Thank you.

Your next question is from the line of David Saxon .

Oh, great. Good afternoon. Thanks for taking my questions. Maybe I'll do a couple on IDOs. So specifically on reimbursement, it looks like some of the IDOs kind of pamphlets or guides that you have posted, it looks like it includes like MedAdvantage and commercial. So I wanted to ask on commercial coverage, like how broad is that coverage from a covered lives perspective? What are you seeing in terms of dollar reimbursement versus what the MACs are doing? And then, you know, I don't know if you can name like the major payers. commercial payers that are most consistent?

Yeah, David. Obviously, I would say first, maybe from a macro standpoint, given the progress we're making with Medicare, we have started to move forward selectively in providing, I'll call it customer patient access into the commercial Medicare Advantage arena. We signaled that was part of our plan, and that's something that we very slowly and methodically began to roll out over the course of really exiting the first quarter into the second. And I would expect us to continue to be equally as methodical as we move forward here, primarily because you want to ensure that your customers have the right experience, the right tools to navigate this more tricky payer landscape successfully. But behind the scenes, You know, our payer relations team and others have been hard at work since really the date of approval. And so on both the commercial as well as the Medicare Advantage side, you see coverage policies that extend out over more than 50% of the potential patient population that are covered by those respective areas. And with the rest, you almost universally see policy silence. And so from our standpoint, we're in the process now of knocking down that same claims adjudication, doing the prior offs, and getting comfortable that it's working the way it's supposed to. And we've had some good early success in seeing claims go through and payers as large as United and as small as some of the more regional plants that are out there. So I think we're in a pretty good spot from a setup standpoint there. It really is much more down to methodical execution and making sure that those customers are doing it the right way in a way that's successful for their practice while they provide access to those patients for iDose.

Okay, great. That was super helpful. Thanks for that. And then in the script, you talked about, you know, expanding the iDose launch. Some of that includes training. I wanted to ask, like, if you could give an update on the percent of kind of your core iStan accounts that you've trained on Eidos, you know, where is the level of demand among doctors for training versus kind of the capacity of the Salesforce to actually do the training? Thanks so much.

Yeah, David, I think it's an important point. We've said it before, but I'll reiterate it here. I don't think that the clinical training, if you will, the OR training, the dry labs, the initial procedures, is in any way the gating item from a capacity standpoint on our sales force, nor from a demand perspective on behalf of the doctors. There are plenty of surgeons every day who continue to want to be trained and add IDOS into their toolkit, and our sales force is more than capable of meeting that demand. I think to the answer of your first question, the more time-consuming and important aspect of all that is making sure that the entire office that surrounds that physician or that surgery center are trained good at adjudicating and processing and following up on the claims that they submit around the product. And as they get better at that, then you start to see the doctor being able to do what they want to do clinically. And that's when we start to have some fun in an account in terms of where IDOS can go.

Your next question is from the line of Adam Mader with Piper Sadler.

Good afternoon. Thank you for taking the questions. Two from me. The first one is on iDose reimplantation. I just wanted to see if there was any update there. I think you were planning to make a post-approval supplement submission to FDA in the first half of the year. So, any updates on the progress you're making with FDA? And how quickly do you expect to know, I guess, you know, kind of one way or the other? And then I had to follow up. Thanks.

And I'm happy to take this question. So, yes. We talked about filing the post-approval NDA supplement in the first half. We've actually done so in the first quarter, so we've beaten that timeline. It's now with the FDA. The FDA has a six-month statutory obligation to get back to us, and so we expect to be able to hear results of their adjudication by year-end.

That's really helpful. Appreciate the color there, Tom. And one maybe for Joe or Alex, you know, I know you guys don't give quarterly guidance, but you did give some helpful color on the last earnings call around kind of sequencing of models. So I wanted to see if there's any updated thoughts in terms of kind of how you see the rest of the year playing out on the top line. And specifically wondering if you had any kind of reaction comment as it relates to Q2 revenue. I show consensus at 101. 16 million and Q2 I-DOS revenue at 25 million. Just any comment on where those figures stand. Thank you.

Yeah, happy to, Adam. I think, as you know, from a seasonality perspective, ophthalmology tends to be, you know, 23%, 24% in the first quarter, 24%, 25% in the second, and similar in the third, maybe down a touch, and then the remainder, you know, anywhere from 27% to as much as 29%, 30% in the fourth. Obviously, ours gets up into it a little bit because of the launch dynamics with IDOS. And sitting here today, I would probably point you to something. Obviously, the first quarter represents about 22% of the midpoint of our guidance. And the second quarter will probably be somewhere in the 23%, 24% neighborhood, followed by 24%, 25% in the third, and call it 28% to 30% in the fourth quarter. And again, the exact pacing and sequencing of IDOS is going to be the key determinant of that on top of what is the underlying seasonality.

Your next question is from the line of Joanne Wilson with Citibank.

Thank you so much for taking the question, and you actually set it up great. So the quarterly pace for the remainder of the year, I think if I back into the guidance commentary, you raised maybe the IDOS guidance by about 5 million. Could you confirm if that's correct? And also, how do you think about the ramp over the subsequent quarters? Thanks.

Yeah, Joanne, I think what I'd probably say is, we'll get that specific, but clearly I said we raised, you know, underlying and implied this is a modest raise to the IDOS expectations. And clearly we expect, you know, from, you know, month to month and quarter to quarter to continue to see the progress. I think when you unpack some of the earlier guidance that I gave and some of the commentary around the various parts of our business cornea, interventional, the stents, et cetera,

and the seasonality you'll um you'll get pretty close to where you need to be from a basic standpoint thank you your next question is from line of margaret andrews with william blair hey good afternoon guys thanks for taking the questions uh two uh both uh around the the stunt side of the business so You know, we were at ASCRS. We did see some data kind of around the benefits and combo procedures for patients. I guess, what do you guys think of these data sets? Are they incremental? Are they more meaningful? You know, can they have an impact on the current LCD? Or what steps, I guess, is the industry taking to potentially overturn the timing of that?

I think from a macro standpoint, you ultimately have to combat that with evidence, right? And so growing evidence, you referenced some, Margaret, around studies that are done by individual practices, groups of practices, manufacturers like Glaucos, ultimately are what help overturn, if you will, restrictions on clinical decision-making, which is what you saw with the LCD in November. So I think you should expect to see more of that from us and from others and from practitioners themselves, because we all know that clinically it makes sense to attack this progressive disease from multiple angles. And so shame on us if we're not generating the evidence to support that.

And I would just add on that, if you think about it, We have been in the driver's seat in combination therapy for some time in multiple modalities, and I think many of you are aware that we're already have completed a phase four clinical trial that compares the iSEN Infinite plus iDose versus Infinite. And our hope and expectation is that study will be able to generate data that will not only convince the operating clinician to go to a place where they already want to go, which is to combine two different modalities to be able to lower target pressures with a single procedure, but also be able to actively support any MAC commercial or Medicare advantage adjudication in the future. So we try to be prescient in doing these studies well in advance of the market trends that we see that are developing in front of us.

Okay. That's helpful. Thank you. And then just, you know, as we look at guidance on stent growth, and apologies if you sort of referenced it, but I'm going to try to get a finer point on it. The stent growth, I think you previously guided to for U.S., kind of flat to down, low single digits. Is guidance now more solidly kind of in that down low single digit range for U.S. stents and anything that we should think about from a comp perspective throughout the year for that specifically? Thanks.

Yeah, Margaret, I did allude to it, but I'll put a finer point on it. The underlying expectation or guidance right now is that for the non-IDOS business, obviously the vast majority of which is stents, that that will be down mid-single digits for 2025. That's based upon, you know, what we saw in the first quarter and a continuation of that trend. And, again, the puts and the takes around that are obviously the restriction impacts in combination with cataract surgery, which are partially offset in our case by continued growth in the standalone side of our stent business. But net-net, we expect the non-IDAS revenues in the U.S. to be down mid-single digits in 2025.

Your next question is from the line of Richard Nooter with Trulia Securities.

Hi, thanks for taking the questions. Can you elaborate a little bit on what assumptions you have for the remainder of the year with respect to your slightly higher IDOS guide with respect to kind of what needs to be in place for additional pro-fee coverage, or can you Can you more or less get to the numbers that you have with the level of reimbursement that you have now and just physicians getting more comfortable going forward? I'm just trying to get a sense for kind of what needs to happen to get to the IDOS numbers in your model.

Yeah, well, maybe I'll look at it a little bit in the way it was asked earlier. So, you know, if I think the number that was thrown out was 21 million for the first quarter. So if you annualize that, you're talking about an $85 million run rate based upon the conditions that existed in the first quarter. Those conditions were obviously a solid payer, if you will, in Noridian, an emerging payer in Novatops and First Coast that really started to turn on more towards the latter part of the quarter entering into the second. And increasingly improved, if you will, adjudication of claims at WPS, Palmetto, and then later on NGS and CGS. So underneath our assumptions is that that trend line continues where first they become all streamlined over the next stretch of time for the J code and the facility. And then usually at some point thereafter, the volumes ultimately drive professional fee schedules. And, you know, In addition to that, as I mentioned, we're going to be slowly, methodically rolling out commercial Medicare Advantage. There are a lot of drivers there that can drive varying outcomes, some of which are obviously more positive than our guidance, some of which are not. I think we've tried to be, I'll call it the wide part of the bell curve, if you will, in the various scenarios in setting the guidance that we have and what that implies for IDOs for the year.

Got it. And if I could just one more. On the combo MIGS within a combo cataract doing more than one MIGS, is idose getting implanted with a MIGS or in concert with agoniotomy? Is that included in kind of the LCD change or is idose actually able to get implanted on a stacked basis?

Yeah, iDoses nor are any procedural pharmaceuticals a part of the LCDs that were published in November, and so the decisions associated with combinatorial use of that are entirely in the hands of the physicians that use the product.

Your next question is from the line of Michael Sarcon with Jefferies.

Good afternoon, and thanks for taking our question. Just to start, you know, maybe following up on Richard's question, I believe last quarter you had mentioned maybe there's just some slight benefit from commercial coverage wins baked into your expectations for iDose this year. Do you think you can comment on, you know, whether or not there have been any changes in kind of the mix of what's baked in for iDose between, you know, traditional Medicare and commercial?

I don't think our commentary, Michael, has really changed in the context of the commercial and Medicare Advantage dynamics as of 2025. What we've tried to say last quarter as well as this one is that we're going to be very methodical in rolling this out. We're going to be methodical in rolling out access to specialty pharmacy distribution as well as buy and build into these customer bases or insurance types. And so, you know, obviously we do expect some contribution over the course of the year from that, but we're really not anchoring our assumptions as it relates to our guidance or IDA's results underneath it based upon positive or negatives associated with the commercial and Medicare Advantage rollout. Those are things that we want to make sure that we're very methodical in doing, and so we're not pinning the forecast based upon a certain level of achievement of volumes out of that.

those those are certain spikes understood thank you and then my my follow-up maybe on the p l um opex any change to your expectations for about 15 percent uh year over year growth off the adjusted 24 base hey mike this is alex thanks for the question and at this point no i mean we would continue to march down this path watching and balancing our investments against the revenues that are generated by idos and the rest of the business

And so we would continue to expect that 15% or so growth off the 2024 base on OpEx for the year.

Your next question is from the line of Anthony Patron with Mizzou Group.

Thanks. And I hope everyone's doing well. Maybe a question just on the Meridian region specifically, iDose, sticking there, US iDose. But if we look at the Neridian region as being sort of further along the product curve here, maybe just an idea of a heavy user in that region. Do you have sites that are getting up to, say, 15, 20 units a month? And even in that region, are there laggards? And what has the product experience been like where we do have a region where reimbursement is quite robust? And I'll have one quick follow-up.

Yeah, Anthony, so for Neridian, which obviously I commented on earlier in the call from a macro perspective, so I'll focus on your sort of customer utilization question. I think it's all of the above. We absolutely have customer and now growing customers, if you will, that are doing the 15 to 20 a month type volume for IDOs within Neridian. And we also have customers who are at very different phases of that adoption, some that are doing their first cases this week and or might be doing just a handful but haven't fully, you know, adopted yet and haven't had it streamlined in terms of their practice and patient selection, all the various things that go into having a successful adoption within a surgical group. We also have areas within the narrating area that are performing much more strongly than others based upon the other dynamics in the context of either hospital approvals or other things that can slow the adoption curve within even that geography where you do have streamlined coverage.

Helpful. And just a quick one here is leveraging the balance sheet. Should we think about leveraging the balance sheet to close the donut holes? That's, I would assume, more a commercial coverage sort of event. But maybe just a recap on the view from Glaucos on leveraging the balance sheet to close the donut hole for iDose. Thanks.

Yeah, I'll take a shot. I think I know what you're saying. The donut hole, and this is a buy and bill product, so it's less about the donut hole, but it's more about the patient out-of-pocket associated with commercial payer lives. And we absolutely intend, like most pharmaceutical products in the fine bill category, to have a $0 copay program. So we will, quote-unquote, use the balance sheet, if you will, to make sure that out-of-pocket coverage costs are not an issue to impeding utilization for those commercial payer patients.

Your next question is from the line of Danielle Antalfi with UBS.

Hello? Can you hear me okay?

We can. Okay.

So sorry about that, guys. Just a high-level question for you guys. As iDose ramps, and I appreciate the 2025 headwinds to the U.S. iStent franchise, but longer term, what do you think is the right way to think about the long-term growth rate for the legacy iStent franchise in an environment where iDose is hopefully ramping pretty rapidly. Like what's the right way to think about the balance of those two businesses and how quickly the legacy iStent business can grow? And I have one quick follow-up after that.

Yeah, Daniel, I think there's a couple different ways to parse that. I mean, first of all, obviously, over the course of 2025, you have just the relative impact of the LCDs as a headwind grows, as we've alluded to, and I think others in the industry have as well. But as you get past that, you're still talking about an industry segment where you're moving from a pretty small patient population in combination with cataract surgery into a very, very large potential patient population in standalone interventional glaucoma. And I think if there was one thing that we certainly took away from the AGS earlier this year and ASCRS more recently, it's that this movement in partnership with physicians and increasingly in alignment with the broader industry, we're really leading the charge that once again change standard of care in glaucoma and improve patient outcomes. I think you know, we have more conviction now that this transformation is convoluted to an IG mindset is well underway. If you look at the sheer number of events, symposiums, and conversations and debates, it's pretty encouraging as you think about that long-term growth dynamic for doing the right thing for patients and intervening early and as needed for these patients. So that's a long-winded way of saying I think you have, you know, a decade-plus period here where both products like IDOS as well as stents and other areas of MIGS alongside of stents can grow in tandem as more and more surgeons adopt a proactive mindset and really go after tackling this disease, which we believe is a surgical one.

Okay, gotcha. That makes sense. And then Just a follow-up on that is iStent Infinite and the standalone market development. I mean, where would you characterize how we are today? What are the barriers that you guys are still addressing there? Because that really does feel like the long-term opportunity here for iStent Infinite. Thanks so much.

Yeah, we agree. And I think, you know, if you think about where we're at relative to those of us in the room and in the building who were there when we were changing the standard of care and pioneering in combination with cataract surgery, I would say, and I think Tom would agree, that we're well ahead of that curve from a timeline perspective in changing the standard of care as it relates to the standalone procedures. Having said that, it never happens as fast as we would want or certainly you all as investors or analysts would want. It takes changing one surgeon's, you know, not just their clinical mindset, but then their operating behaviors and the things they do to educate their referral networks and ultimately getting these patients treated in an interventional way. And the good news is we're well underway on that front with quite a few early adopters that have already shifted their patterns. And that's only growing. And as I mentioned, that was on full display at ASCRS. And we couldn't help but be pleased with what we were seeing.

Yeah, I was just going to say that with what's happened just in the last, really, 18 months or so, since we have really turned our turrets towards this intervention of our compromise set and mind frame, you can see it at AGS, you see it at ASCRS. There's clearly going to be a strong movement in the direction that we want. I think that the standalone is an incredible, unexploited opportunity, not only for ice and infinite, but as you think about it and do your models in the future, as I said earlier, what I do believe strongly is that surgeons will increasingly look to be able to take and be able to place a procedural pharmaceutical, in this case an eye dose, in combination with an infinite to be able to maximize their opportunity to lower target pressures and and preserve the vision of these glaucoma dissipations. And so I think you're going to see growth on both sides. I don't think they'll happen at the expense of each other. I think that these two products can work in tandem, particularly in the outer years as surgeons become increasingly comfortable placing dual modalities into the eye.

Our final question will come from the line of Patrick Wood from Morgan Stanley.

Perfect. Thanks so much. I'll keep it just to one. I'd love to hear a little bit about what you guys are hearing back from the patients and also the docs conversations with the patients when it comes to iDose. Is this a quick and easy conversation and there's quite a lot of buy-in from the patients right away? I mean, it seems a fairly easy value prop to communicate, but obviously you have the doc buy-in already. I'm just curious, like, how you feel the conversations between the docs and the patients are going, and if you've had any feedback around that.

Thanks.

Yeah, Patrick, I think that from a physician standpoint, there's always a journey around the conversation they have with patients, in particular where you're recommending, you know, interventional glaucoma procedure, and in this case, obviously, IDOS. But what you see is Every day them getting better at that and certainly as folks become more comfortable and confident with the outcomes which we're seeing are terrific. that enables them to then speak with that much more confidence to the patients who are walking into their practice and recommending it as something that they would do for their own eye or for their mother's eye if they were afflicted with glaucoma. And so I think we're making tremendous progress there. And most important, the foundation that underpins all of this is that the product is performing as advertised and as a result of physician enthusiasm continues to grow around it. Downstream of that, they will continue to perfect how they operate, how they talk to patients, and all the various things that ultimately, you know, make this become what we think it will be. Great stuff. Thanks, guys.

Thanks, guys. I will now hand the call back over to the company for closing remarks.

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

This concludes today's call. Thank you for joining. You may now disconnect your lines.