Conference Transcript - GKOS 2026-06-16

Rich Newitter, Analyst — Truist Securities

Good morning, everyone. I'm Rich Newiter, MedTech Analyst at Truist Securities. Thanks for joining us. Very lucky to have Glaucos Management, Alex Thurman, Chief Financial Officer, and Chris Lewis, Head of Investor Relations, joining us. Welcome, gentlemen, and thanks for attending this year.

Alex Thurman, CFO

Hey, Rich, thanks so much for having us. Chris and I are grateful for you taking the time and the effort to do what we do over the Zoom today. As you know, or for those in the room that we apologize, we actually made a good faith effort to get there yesterday. Chris and I sat in LAX most of the day as our flight got delayed and delayed and delayed and then finally canceled. So thank you for making the switch and allowing us to participate virtually today with you all.

Rich Newitter, Analyst — Truist Securities

Excellent. So we got a lot of ground to cover. I want to make sure I use our time wisely. I thought, you know, a good place to start. We want to make sure we talk about, you know, business trends for Eidos and Epiaxa, and we'll get to those. but maybe maybe we'll start off on IDOS. You know, you're coming off a really strong start to the year here. You had a I would call it an inflection like IDOS performance in 1Q. And that fueled close to 60% US glaucoma growth in the quarter. Feels like reimbursement frictions are starting to improve. I just love an update. You know, just where where you see the reimbursement environment compared to two or three months ago and kind of are we are we out of the woods on the you know the the physician fee kind of uh you know bottleneck uh and and and how should we think about the regular way trend we'll get into the lcd you know consideration later but maybe start off

Alex Thurman, CFO

there absolutely um oh i would say rich i mean you're right we were very pleased with kind of we saw in the first quarter and the momentum of Eidos. And I think we're getting closer to getting through all of these reimbursement hurdles. As most of you know, you know, we got Palmetto in the first quarter as the latest Mac to approve or to post a professional fee schedule. There's only two left. You know, CGS and NGS. Well, NGS came in. Sorry. CGS and WPS are the only ones left. We're hopeful with this LCD process and those two Macs being part of it, that they'll produce or publish a profiling schedule soon, and we're waiting for that. And I think that's really going to get us from a Medicare fee-for-service standpoint over the hurdles, the last remaining hurdles. And from there, we hope to see more momentum grow in that part of the segment. In addition, we've seen some really nice progress on the Medicare advantage and commercial fronts you know as as we've talked about we have pretty wide range of coverage in those two channels and one of the focuses coming into the year for joe and his team was to really drive into those two channels and start to grow that part of the business within idos and and the whole point there is to really get to the stage with our customers that when they see a glaucoma patient they're not thinking about the insurance which insurance they have whether it's medicare for service or a medicare advantage plan or a commercial plan it really doesn't matter we're supporting them in all three of those channels and they can just really treat that patient clinically and i think during this over the course this year we'll get to that point

Rich Newitter, Analyst — Truist Securities

got it uh i actually just got a an inbound saying if you guys can move a little closer to your mic um there's someone on the webcast having a little bit trouble hearing um got it no that's very helpful i guess just just on that can you break down the the um you know the population elige the eligible population for idos with respect to commercial medicare uh

Chris Lewis, Head of Investor Relations

advantage and then a fee for service traditional yeah yeah um so historically our our glaucoma us business has been about 75-80% Medicare and 25-30% commercial. Within that, national averages are, you know, as you know, Medicare fee-for-service is about 50% of traditional Medicare, overall Medicare and MA or Medicare Advantage is roughly the other 50%. So if you're looking at it that way, kind of do 40% fee-for-service, 40% Medicare Advantage, 20% commercial in terms of the historical precedent and the national averages in terms of the applicable populations. The one caveat we throw in there as we think about IDOS, given it's not or doesn't have to be tied to cataract surgery, which typically happens later than the first onset of glaucoma. In the phase three studies for IDOS, for example, we saw about 50% of the randomized subjects were below the Medicare age limit. So that would suggest with IDOS, you may see increasing mix towards commercial. I don't think it will get to the 50% anytime soon, just given how early the stages we are in terms of the Medicare world and Medicare fee-for-service specifically. But it gives you a sense of, you know, how the magnitude of how large that specifically commercial population can be over time.

Rich Newitter, Analyst — Truist Securities

got it and um i want to get more granular into the lcd and kind of your proposal and your views there but one of the things we'll we'll ask and talk about is obviously what how quickly can this open up the medicare advantage population and eventually commercial because that is one of the potential positives from the proposed LCD here, sorry. So actually, why don't we pivot to the LCD discussion? Maybe before we get into the Medicare Advantage stuff, just the mix of your standalone business, your combo cataract, and then what about combo MIGs? Can you just break that down for us? Because that's going to have relevance for the for the different, you know, step edits that are being being looked at and evaluated right now.

Chris Lewis, Head of Investor Relations

Yeah. So, Rich, as you know, and I think as most investors know, you know, as part of the part of the launch, we focused on the standalone procedural market opportunity. And the reason for that is, of course, to kind of streamline the claims and adjudication process and keep those clean as you continue to build professional fees, which, again, as we've talked about, we've done now, you move into kind of meet the surgeons where they are. So the majority of our procedures remain standalone based on all the data we see. But certainly the combo cataract segment continues to grow. I don't think it's we don't think it's at 50 percent yet, but it's certainly trending towards that direction. And that makes sense. Right. You're meeting the surgeon where they are clinically. And from an efficiency standpoint, it makes all the sense in the world to treat cataract and glaucoma in the same procedure, if you can, two different disease states. And so a lot of synergies from a clinical perspective and, again, an efficiency perspective to do that. In terms of the eye dose plus surgical MIGs, that's also an area that continues to grow, given clinically a lot of surgeons see the benefit of, you know, the mechanisms of actions being different but complementary as well. continues to be a smaller piece of the overall mix, but growing as well, as expected.

Rich Newitter, Analyst — Truist Securities

Yep. And then, sorry, the combo MIGs, or MIGs plus Eidos, whether it's combo cataract or standalone, just what, our checks have suggested a wide range, right? Anywhere from, we've heard some docs say 20 percent some docs are doing that and 40 percent of their kind of cases across combo and standalone is that you know do we take the midpoint of that like what what what can you tell us about that that range are we are we in the ballpark does that sound right yeah you know i

Chris Lewis, Head of Investor Relations

don't i don't think we get overly granular on that but i i think those are those are reasonable type ranges we've seen and heard out there it really varies from surgeon to surgeon again uh maybe be lower than that, maybe higher than that, depending on the surgeon and the approach they take. But again, it's a smaller piece relative to the other two, but growing as well. Okay.

Rich Newitter, Analyst — Truist Securities

And then SLT. Well, actually, before we even go there, let's just high level, you know, you saw the LCD. I think you've mentioned that you were actually somewhat surprised that you saw it. You didn't think one was imminent, and then we saw it. So just why were you surprised? What are your high-level views right now? You've had a few weeks to see some feedback and response from societies and the surging community. What have you learned? How are you feeling? What do you think the prospects are that this potentially gets revised on some level?

Alex Thurman, CFO

No, it's a great question. And, yeah, we were a little bit surprised for a couple of reasons. I think first and foremost, you know, Eidos is really early in its launch curve. and the volumes just aren't that big. And so it was somewhat surprising to see an LCD process start this early in a product's launch curve. But setting that aside, the other reason was, you know, typically what we've seen in the past with other LCDs and that process is a lot of times these Macs will speak to leading KOLs as they start to draft their LCDs. And those KOLs are our customers. And we typically, you know, those are the smoke signals that we tend to hear from that give us an idea that something's coming. And we really didn't see that in this case. And that's why we've mentioned on previous calls and meetings that we hadn't seen any smoke signals around an LCD coming imminently. And so, you know, they did come. And obviously, you know, that's part of the process and what we're dealing with it. I think we were pleased in the first open meeting, whenever that was 10 days ago or so, to see the societies come out and some of the physicians in support of Eidos and to hear what they had to say, specifically around kind of treatment patterns that are seen in the real world and how some of the language in the LCD might restrict that. And then also one of the doctors talked very highly around the combination, as you were mentioning, between using Eidos and a MIGS device and how that can really help the patient and provide an extra punch, so to speak, against the disease. So we were pleased to see all that. And again, this is all part of this education process as the maps go through the open comment period and we'll have another one I think later this week and we'll be anxious to see how those customers and societies are still hopefully supporting us in our efforts.

Rich Newitter, Analyst — Truist Securities

And out of the three or four areas that the LCD addresses, it sounds like the SLT step at it and followed by the combo MIGS item were probably the two that investors are most focused on. It sounds like re-administration being different than what the FDA label is. That probably is something that can be rectified at some point. So let's just focus on the SLT first and then combo MIGs because we have data. You know, if this were to go in as proposed, can you just help us think through where your exposure is and what this could potentially mean for physicians who have to potentially work up a backlog of patients that either fail SLT or get SLT in the first place? What percentage of IDOs patients get SLT right now based on what you see? and is there enough of an ongoing pool of patients out there that you're not going to have to start from scratch to get high-volume high-dose physicians to work up a backlog?

Chris Lewis, Head of Investor Relations

Yeah, I think it's important, but even before we get into that, I think it's important just to reiterate, I think, what we've talked about in some other public forums and that SLT is a well-established first-line interventional approach and has been for a decade plus. So we don't necessarily fight SLT, but SLT is not appropriate for every patient, depending on the disease severity, the anatomy, prior interventions, comorbidities, physical limitations of actually sitting at the slant lamp, and then ocular inflammation and a bunch of hosts of other contraindications for a variety of reasons. A certain portion of patients just aren't eligible or clinically appropriate for SLT, despite it being a first-line, well-established, well-accepted intervention. So I think that's why we believe, at minimum, clinically, you need to have those carve-outs to not just have a blanket SLT requirement ahead of itis or any other intervention or therapy, for that matter. So I think that's important to remember here. In terms of like, you know, if you were to assume it got finalized as proposed, and again, we don't believe that based on one, the precedent, and two, there's no real data to support SLT being ahead of IDOS for any clinical reasons that we've seen or heard. But again, if you're trying to take that approach, then analytically, you also have to appreciate, you know, the numbers around SLT and what that could even mean, even in that segment of post-SLT failure. And what we know is based on plenty of credible sources is that there's, you know, 500,000, 600,000 SLTs being performed every year in the U.S. Again, that's been well-established for a decade plus. When you look at other like-minded laser procedures, you're probably getting to 800,000 to 900,000, just for example. We know failure rates with SLT based on Bovell and other real-world studies are typically 50% at two years, 75% to 80% plus at five years. So when you take a step back to your point, there's a prevalence pool of probably millions of I's in the U.S. right now that are post-SLT failures. And then from an incidence rate, if you assume that 75% five-year failure rate, you're looking at nearly 500,000 annual I's that are joining that SLT failure rate pool every year. So when you when you apply an IDOS ASP to that, you're looking at, obviously, a market that's magnitudes of where IDOS is today. And I think that's important to remember.

Rich Newitter, Analyst — Truist Securities

But it probably still would take some time to kind of work through that, get all documentation right, even for the prevalence pool and whatnot. So there will be an impact, but it sounds like you're saying you even think if it goes in as proposed, notwithstanding those that can't get an LCL, that are contraindicated for an SLT for some reason, that this should be manageable, you know, once we get past that initial, you know, initial period of implementation?

Chris Lewis, Head of Investor Relations

I think that's certainly our view that this is manageable regardless. Now, given, you know, some surgeons are already there in terms of, you know, having those SLT patients in their practice, identifying them, treating them as part of the normal course of their disease progression. Other surgeons you talk to, and there's been a variety, I think, on the Wall Street calls, et cetera, it's not necessarily part of their practice. That doesn't mean that those patients haven't had SLT in the past. That's important to remember as well. So I think it depends. To your point, if that did become a requirement, I think surgeons who want to do Eidos would evolve and hopefully evolve rather in an efficient way to find, incorporate, target those types of patients to make sure those are the ones being treated. We would obviously evolve our marketing, targeting efforts, DTC efforts that are just now getting underway for IDOS and to come with Epioxa to find every one of those patients out there that has SLT. And again, that's a significant large population.

Rich Newitter, Analyst — Truist Securities

And then going back to what we were discussing a couple of minutes ago, the Medicare Advantage patient population access consideration. Can you just help us think through when that could realistically begin to unlock? And then even on that, one of the pushbacks we get is, well, yeah, that's great. Maybe they're more eligible, but you're going to have copay potential pushback there. So maybe just talk about that. How big of a hurdle do you think that will be? And what can

Alex Thurman, CFO

you do, if anything, to help with that? Yeah, I mean, we've always talked, Rich, about the Medicare Advantage being kind of the last frontier of the three channels. And that co-pay dynamic is the major reason, right? As I mentioned earlier, we're pleased with kind of the coverage we have already today before these LCDs came out on the Medicare Advantage size. But again, when you're talking about a Medicare Advantage patient and depending on what their co-pay situation is with their plan. And I'll say as an aside, there are about 10 to 15 percent of those Medicare Advantage patients that have that plan, that have a plan that is little to very modest out-of-pocket obligations. And so, you know, those obviously we can treat and Eidos wouldn't be a burden for them. But of the rest, which are the majority for sure, they would have a copay obligation. And then it depends on, you know, typically it'll depend on what time of year it is. You know, we are not allowed by law to provide any copay assistance, as you mentioned, but in those, you know, a lot of times what we'll see is those Medicare Advantage patients have gone through the year and have some other kind of procedure, whether that be a knee, a heart, or something that has sucked up, let's call it their copay, and they get into the late third quarter, fourth quarter, and their copay obligation has reached the federal out-of-pocket maximum and therefore idos doesn't become a you know a problem or a hurdle for them on a copay standpoint got it but you you you do think that

Rich Newitter, Analyst — Truist Securities

this will still be you know even with that 10 to 15 percent in the the situations you just described a net offset on some level to whatever slow down as temporary as it may be due to kind of slt work up if obviously all this goes in as proposed. Yeah, I think what we've said and what

Alex Thurman, CFO

our view would be is there's multiple pathways to get to kind of what the street is expecting from a high-dose perspective today and this year and next year as well. Got it. And then

Rich Newitter, Analyst — Truist Securities

just thinking about the combo MIGs, you guys have some data coming there. So whether or not that gets softened between now and the final it. Tell me if, you know, our thesis working thesis is at least you're going to have data on the near ish horizon or intermediate term horizon that could potentially allow for a reevaluation of that particular criteria. Where are you on that data set? When do you think that could potentially be, you know, officially published or circulated and do you even need it to be completely finished to begin to socialize it with the max to potentially reopen whatever goes into a finalized effect yeah so we have uh

Chris Lewis, Head of Investor Relations

so we have a phase four uh several phase four studies underway uh randomized control type you know level one studies uh idos plus infinite versitis alone is one of those studies that were you know we candidly started uh short order coming out of the approval but you you need approval before you can really take the next step there so um idos and combo cataract idos plus infinite uh and others right and so we have uh we're continuing to advance all of those studies but specifically for the idos plus infinite study um our plan um all along has been to have data in hand by at some point in 2027. So regardless of, I guess, where that proposed, you know, restriction may or may not go, if this does go to a final rule, as you think about the 7 to 12 month typical timing of when that actually would become finalized and effective, we'd in short order be able to, to your point, you know, submit what's called a reconsideration request with that data that would be published. I think even before that, and I think you saw this from one of the participant doctors on the open meeting last week, you know, there's other peer-reviewed data sets coming out from surgeon real-world, you know, case studies showing the benefit of IDOS plus not only our MIGs, but other MIGs. And the reason for that, Rich, is just to remind everybody, Eidos is approved as and operates as a pharmaceutical. At the end of the day, it's a travel prostaglandin analog. So from a mechanism of action standpoint, very different and complementary than the surgical MIGS approaches that really work on the outflow trabecular meshwork pathway. This is completely separate and complementary. And hopefully that's It's an area of education during these open meetings and during the open comment period as well.

Rich Newitter, Analyst — Truist Securities

I want to move on to Epiaxa, but the last quick one on the eye dose. Do you think there could be some pull forward here just as people try to get things in, you know, before this goes into effect? Do we hear anything?

Alex Thurman, CFO

Well, if we look back at some of the previous LCDs that came out, specifically with the Combo MIGS one, it happened whenever that was a year or two years ago. You know, certainly that's a possibility. And I think, you know, there are going to be doctors that will do that. But overall, you know, when we look back at the history there, we didn't see a lot of pull forward in our MIGS business when the proposal came out to, you know, kill or squash goniotomy and canaloplasty. But I think, you know, if you're a smart rep, you're going to be out there probably saying that to try and push your customers to buy now. But we're not seeing, you know, we're not expecting it. Let's just say we're not counting on that.

Rich Newitter, Analyst — Truist Securities

Got it. So switching gears to Epiaxa, just high level, how's the launch so far going relative to your expectations? And just remind us on what you're doing currently on reimbursement, you know, between now and, you know, July 1st, you get the J code officially. What should we expect when that happens as well?

Alex Thurman, CFO

Well, I'll start and talk about the launch specifically. I'll let Chris talk about the reimbursement. But, you know, the launch is gone. You know, we've said it and we've been on record. It's ahead of our expectations as far as how things are going. We've talked about this whole Epioxa launch being an opportunity for the company to change the whole go-to-market approach with Keratoconus and overcome the challenges and the hurdles we've had with the legacy of the Trexa business. And so part of that, there's a couple of key work streams within that change, one of which Chris will talk about in a minute, which is the reimbursement side. But a second key work stream is the idea or the approach we're taking to really shrink our side of care service network in order to treat these patients. We realized as we went through the journey, the six years of owning Patrexa, that this really keratoconus is a rare disease. And at the keratoconus price point, we really weren't able to grow the market or to expand it beyond the 10,000 patients that we were really treating consistently over those six years. And part of that was you had a really broad and wide side of care network with the Petrexa boxes. And so with Epioxa, the whole idea is really to hone in and focus on more high-volume customers because we'll be making a large investment in supporting that infrastructure and those customers as they really bring in these caretoconus patients and treat them. And behind all of that, we've got a hub and we've got patient access liaisons and other support functions to really drive that rare disease model. And so that's going better than expected. You know, the customers that we reached out to and asked if they would be willing to participate in this new Cytocare network were very enthusiastic. And so that's going ahead of schedule. And then I'll let Chris talk about reimbursement.

Chris Lewis, Head of Investor Relations

Yeah, certainly several kind of work streams there on the reimbursement market access landscape. One, to your point, is the miscellaneous to permanent J-code. So our permanent product-specific J-code becomes effective July 1st. That's a big, important kind of milestone in terms of helping to optimize and streamline the reporting and processing of claims over time. It's not a green light in terms of overnight success, but certainly helps from a contracting perspective and ultimately adjudication perspective. So it doesn't mean right now you can put claims through under miscellaneous code. It just requires more work. There's typically more back and forth, et cetera. From an access pathway perspective, we've been really encouraged of the progress and discussions we've had with the commercial payers. Remember this, unlike Eidos and mostly that being Medicare, Photrexia historically, this is a younger disease, so mostly all commercial. So we're really dealing with the commercial payer world here as part of this launch, as it has been with Photrexia. But we've made some really nice progress in these early days. We've talked about more than 100 billion commercial lives have access pathways now, whether that's through updated actual policies or other avenues from commercial payers. four of the five largest commercial payers here in the U.S. have access pathways. And so we've been really encouraged. We continue to advance those efforts. Ultimately, you know, the expectation is obviously as part of any launch like this, you'll get the denials and you'll have to go through the appeals and the peer-to-peer request meetings, et cetera, as part of these early days. The goal ultimately is to get that, you know, kind of combed out or, you know, optimized here over the, you know, over the second to third quarter. And then as you get into the fourth quarter and exit this year into next, you're hopeful it would be in a pretty good spot there, at least with some of the major commercial payers and plans.

Rich Newitter, Analyst — Truist Securities

Got it. Just going back to a comment you made about there's multiple ways to get to the IDOS numbers, I think is what you said. The consensus IDOS number is 26, 27, you know, with the puts and the takes, even if a, quote, worst case as proposed into final would transpire for the for the LCD. That was independent of the epiaxa contribution. And it's like so many it's like 3D chess. you've got all these different permutations and epiox is a potential big upside driver in our view relative to street expectations so i just want to be clear though you said there's there's likely multiple ways that you can get to the idos numbers even if there were to be frictions that you had to contend with in 2027 from the proposed uh step edits going into final is that

Alex Thurman, CFO

right yeah that's right i mean we didn't even talk about it rich but there's you have to think about NGS has just started to contribute as two max ago, the one that prevailed the pro fees. As I mentioned earlier, Palmetto just started in their pro fees in the first quarter. Those typically start to roll up, and then we've got two more coming. So we've got additional utilization increases in the existing pool of max. And that's just one example of other pathways. Again, as Chris had mentioned at some point, we're really just still in the early innings on really digging into the potential population of patients that are eligible for an eye dose.

Rich Newitter, Analyst — Truist Securities

And then if I could just squeeze one more in. I mean, it sounds like the Epioxal launch so far, you know, going a little better than your original expectations. It's going to take time. Not going to be a light switch with the J-code. But it sounds like you're optimistic there. You know, we hear a lot about Epion Therapeutics. They're probably going to have data in the not too distant future here. Just how do we think about, you know, that that company coexisting potentially with you in the marketplace? How are you thinking about the market evolving if, you know, you have to share it with them?

Alex Thurman, CFO

Sure, I'll say that. I mean, look, we know that when you're in a in this case, what we've described is a rare disease marketplace, which has a lot of opportunity and potentially a lot of revenues associated with it, there's going to be competitors. And so Epion is one of those competitors. We'll continue to watch as they come out, and we'll look for their data. And we think just that we have strong data, and one of our distinguishing part of the treatment that we do with Epioxide, we think oxygen is a key component of that treatment in doing the cross-linking. This is something that they don't currently use. And so that's a couple of things we'll watch. We do think that it is potentially a big market. And so it's not like it's a one winner, one loser as well. And the last thing I'll say on that is we have a, call it a third generation keratoconus treatment coming down. And you'll hear more about that. We've talked a little bit about it, but we think it's a very exciting. And we're in phase two on that and moving into phase three next year, next year. And so stay tuned to hear more about that technology.

Rich Newitter, Analyst — Truist Securities

Great. We're right. We're about a minute over. But thank you to both of you for making this happen. Sorry you had to spend so much time on the tarmac yesterday. But thanks to both of you. No worries. Thanks, guys. Thanks for having us.

Alex Thurman, CFO

Sorry we couldn't be there. Take care.