Good morning, everyone. I'm Richard Newitter, medtech analyst at Truist Securities. Thanks for joining us. Very lucky to have Glaukos management, Alex Thurman, Chief Financial Officer, and Chris Lewis, Head of Investor Relations, joining us. Welcome, gentlemen, and thanks for attending this year.
Hey, Rich. Thanks 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 finally canceled. Thank you for making the switch and allowing us to stay virtual today with you all.
Excellent. We got a lot of ground to cover. I want to make sure I use our time wisely. I thought a good place to start, we want to make sure we talk about business trends for iDose and Epioxa, we'll get to those. Maybe we'll start off on iDose. You're coming off a really strong start to the year here. You had a, I would call it, an inflection-like iDose performance in 1Q, and that fueled close to 60% U.S. glaucoma growth, in the quarter. Feels like reimbursement frictions are starting to improve. I'd just love an update, just where you see the reimbursement environment compared to two or three months ago, and are we out of the woods on the physician fee bottleneck, and how should we think about the regular way trends?
We'll get into the LCD consideration later, maybe start off there.
Absolutely. Well, I would say, Rich, you're right. We were very pleased with what we saw in the first quarter and the momentum off of iDose, and I think we're getting closer to getting through all of these reimbursement hurdles. As most of 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, CGS and NGS. 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 pro fee schedule soon, and we're waiting for that.
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. 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 iDose. 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 fee-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. I think over the course of this year, we'll get to that point.
Got it. I actually just got an inbound saying if you guys can move a little closer to your mic.
Interesting.
There's someone on the webcast having a little bit of trouble hearing. Got it. That's very helpful. I guess, just on that, can you break down the
Yes
the eligible population for iDose with respect to commercial Medicare Advantage and then fee-for-service traditional?
Yeah. Historically, our glaucoma U.S. business has been about 75%-80% Medicare and 25%-30% commercial. Within that, national averages are, as you know, Medicare fee-for-service is about 50% of traditional Medicare or overall Medicare and MA or Medicare Advantage is roughly the other 50%. If you're looking at it that way, 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'd throw in there, as we think about iDose, 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 III studies for iDose, for example, we saw about 50% of the randomized subjects were below the Medicare age limit. That would suggest with iDose, 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. It gives you a sense of how the magnitudes of how large that, specifically that commercial population could be over time.
Got it. I want to get more granular into the LCD and your proposal and your views there. One of the things we will ask and talk about is obviously 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. 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 different step edits that are being looked at and evaluated right now.
Yeah. Rich, as you know, and I think as most investors know, as part of the launch, we focused on the standalone procedural market opportunity. The reason for that is, of course, to 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 meet the surgeons where they are. The majority of our procedures remain standalone based on all the data we see. Certainly, the combo cataract segment continues to grow. We don't think it's at 50% yet, but it's certainly trending towards that direction. That makes sense. You're meeting the surgeon where they are clinically and from an efficiency standpoint, makes all the sense in the world to treat cataract and glaucoma in the same procedure if you can.
Two different disease states, a lot of synergies from a clinical perspective, and again, an efficiency perspective to do that. In terms of the iDose plus surgical MIGS, that's also an area that continues to grow given clinically a lot of surgeons see the benefit of 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.
Yep. Then, sorry, the combo MIGS or MIGS plus iDose, whether it's combo cataract or standalone, our checks have suggested a wide range. Anywhere from, we've heard some docs say 20%, some docs are doing that in 40% of their cases across combo and standalone. Do we take the midpoint of that? What can you tell us about that range? Are we in the ballpark? Does that sound right?
Yeah. I don't think we get overly granular on that, but I think those are reasonable type ranges we've seen and heard out there. It really varies from surgeon to surgeon, again. It may be lower than that, maybe higher than that, depending on the surgeon and the approach they take. Again, it's a smaller piece relative to the other two, but growing as well.
Okay. Then SLT. Well, actually, before we even go there, let's just high level. 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, then we saw it. 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 surgeon community. What have you learned? How are you feeling? What do you think the prospects are that this potentially gets revised on some level?
No, it's a great question. Yeah, we were a little bit surprised for a couple of reasons. I think first and foremost, iDose is really early in its launch curve, and the volumes just aren't that big. So it was somewhat surprising to see an LCD process start this early in a product's launch curve. Setting that aside, the other reason was, 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. Those are the smoke signals that we tend to hear from that give us an idea that something's coming. We really didn't see that in this case.
That's why we've mentioned on previous calls and meetings that we hadn't seen any smoke signals around an LCD coming imminently. So they did come, and obviously, that's part of the process and 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 iDose and to hear what they had to say, specifically around treatment patterns that are seen in the real world and how some of the language in the LCD might restrict that. Also one of the doctors talked very highly around the combination, as you were mentioning, between using iDose and a MIGS device and how that can really help the patient and provide an extra punch, so to speak, against the disease.
We were pleased to see all that. Again, this is all part of this education process as the MACs go through the open comment period. 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.
Out of the three or four areas that the LCD addresses, it sounds like the SLT step edit and followed by the combo MIGS item were probably the two that investors are most focused on. Sounds like re-administration being different than what the FDA label is, that probably is something that can be rectified at some point. Let's just focus on the SLT first and then combo MIGS because we have data. 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 iDose patients get SLT right now based on what you see? 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 iDose physicians to work up a backlog?
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. 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 slit lamp, and then ocular inflammation and a bunch of host 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.
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 iDose or any other intervention or therapy for that matter. I think that's important to remember here. In terms of if you were to assume it got finalized as proposed, again, we don't believe that based on, one, the precedent, and two, there's no real data to support SLT being ahead of iDose for any clinical reasons that we've seen or heard. Again, if you're trying to take that approach, then analytically, you also have to appreciate the numbers around SLT and what that could even mean, even in that segment of post-SLT failure. What we know is based on plenty of credible sources, is that there's 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 800,000-900,000, just for example. We know failure rates with SLT based on Bovell and other real-world studies are typically 50% at two years, 75%-80% plus at five years. When you take a step back to your point, there's a prevalence pool of probably millions of eyes in the U.S. right now that are post-SLT failures. From an incidence rate, if you assume that 75% five-year failure rate, you're looking at nearly 500,000 annual eyes that are joining that SLT failure rate pool every year. When you apply an iDose ASP to that, you're looking at obviously a market that's magnitudes of where iDose is today. I think that's important to remember.
It probably still would take some time to kind of work through that, get all the documentation right, even for the prevalence pool and whatnot. 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 SLT, that are contraindicated for an SLT for some reason, that this should be manageable once we get past that initial period of implementation.
I think that's certainly our view, that this is manageable regardless. Given some surgeons are already there in terms of 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. I think it depends. To your point, if that did become a requirement, I think surgeons who want to do iDose 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 iDose and to come with Epioxa to find every one of those patients out there that has SLT. Again, that's a significant large population.
Going back to what we were discussing a couple of minutes ago, the Medicare Advantage patient population access consideration is, can you just help us think through when that could realistically begin to unlock? 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. Maybe just talk about that. How big of a hurdle do you think that will be, and what can you do, if anything, to help with that?
Yeah. We've always talked, Rich, about the Medicare Advantage being kind of the last frontier of the three channels, and that copay 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. Again, when you're talking about a Medicare Advantage patient and depending on what their copay situation is with their plan, I'll say as an aside, there are about 10%-15% of those Medicare Advantage patients or that have that plan, that have a plan that is little to very modest out-of-pocket obligations. Those obviously we can treat and iDose wouldn't be a burden for them.
Of the rest, which are the majority for sure, they would have a copay obligation. Typically, it'll depend on what time of year it is. We are not allowed by law to provide any copay assistance, as you mentioned. 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, iDose doesn't become a problem or a hurdle for them on a copay standpoint.
Got it. You think that this will still be, even with that 10%-15% and the situations you just described, a net offset on some level to whatever slowdown, as temporary as it may be, due to kind of SLT workup, if obviously all this goes in as proposed.
Yeah. I think what we've said and what our view would be is there's multiple pathways to get to what the Street is expecting from iDose perspective today and this year and next year as well.
Got it. Just thinking about the combo MIGS, you guys have some data coming there. Whether or not that gets softened between now and the final, tell me if our 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 officially published or circulated, and do you even need it to be completely finished to begin to socialize it with the MACs to potentially reopen whatever goes into a finalized effect?
Yeah. We have several phase IV studies underway, randomized control type, level one studies. iDose plus Infinite versus iDose alone is one of those studies that we candidly started short order coming out of the approval. You need approval before you can really take the next step there. iDose and combo cataract, iDose plus Infinite, and others. We're continuing to advance all of those studies, but specifically for the iDose plus Infinite study, our plan all along has been to have data in hand by at some point in 2027.
Regardless of, I guess, where that proposed restriction may or may not go, if this does go to a final rule, if 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 your point, 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, there's other peer-reviewed data sets coming out from surgeon real world case studies showing the benefit of iDose plus not only our MIGS, but other MIGS. The reason for that, Rich, is just to remind everybody, iDose is approved as and operates as a pharmaceutical. At the end of the day, it's a travoprost prostaglandin analog.
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 an area of education during these open meetings and during the open comment period as well.
I want to move on to Epioxa, the last quick one on iDose. Do you think there could be some pull forward here, just as people try to get things in before this goes into effect? Are we hearing anything?
Well, if we look back at some of the previous LCDs that came out, specifically with the combo MIGS one that happened whenever that was, a year or two years ago, certainly that's a possibility, and I think there are going to be doctors that will do that. Overall, 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 kill or squash goniotomy and canaloplasty. I think, 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. We're not expecting it. Let's just say we're not counting on that.
Got it. Switching gears to Epioxa, just high level, how's the launch so far going relative to your expectations? Just remind us on what you're doing currently on reimbursement between now and July 1st, you get the J-code officially. What should we expect when that happens as well?
Well, I'll start and talk about the launch specifically. I'll let Chris talk about the reimbursement. The launch has gone, 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 Photrexa business. 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. A second key work stream is the idea or the approach we're taking to really shrink our site of care service network in order to treat these patients.
We realized as we went through the journey, the six years of owning Photrexa, that this really, keratoconus is a rare disease. 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. Part of that was you had a really broad and wide site of care network with the Photrexa boxes. 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 keratoconus patients and treat them. 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. That's going better than expected.
The customers that we reached out to and asked if they would be willing to participate in this new site of care network were very enthusiastic. That's going ahead of schedule, then I'll let Chris talk about reimbursement.
Certainly several kind of work streams there on the reimbursement market access landscape. One, to your point, is the miscellaneous to permanent J-code. 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, an adjudication perspective. 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 iDose and mostly that being Medicare, Photrexa historically, this is a younger disease, mostly all commercial.
We're really dealing with the commercial payer world here as part of this launch, as it has been with Photrexa. We've made some really nice progress in these early days. We've talked about more than 100 million 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. We've been really encouraged. We continue to advance those efforts. Ultimately, 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 kind of the combed out or optimized here over the second to third quarter.
As you get into the fourth quarter and exit this year into next, you're hopefully would be in a pretty good spot there, at least with some of the major commercial payers and plans.
Got it. Just going back to a comment you made about there's multiple ways to get to the iDose numbers, I think is what you said. The consensus iDose number is 2026, 2027. With the puts and the takes, even if a, quote, "worst case" as proposed into final were to transpire for the LCD, that was independent of the Epioxa contribution. There's so many, there's like 3D chess. You've got all these different permutations, and Epioxa's a potential big upside driver in our view.
Yeah
Relative to street expectations. I just wanted to be clear, though. You said there's likely multiple ways that you can get to the iDose numbers, even if there were to be frictions that you had to contend with in 2027 from the proposed step edits going into final. Is that right?
Yeah. That's right. We didn't even talk about it, Rich, but you have to think about NGS is just starting to contribute as two MACs ago, the one that prepped as pro fees. As I mentioned earlier, Palmetto just started in their pro fees in the first quarter. Those typically start to roll up. We've got two more coming. We've got additional utilization increases in the existing pool of MACs. 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 iDose.
Okay. If I could just squeeze one more in. It sounds like the Epioxa launch so far, going a little better than your original expectations. Going to take time, not going to be a light switch with the J-code.
Yeah.
It sounds like you're optimistic there. 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 that company coexisting potentially with you in the marketplace? How are you thinking about the market evolving if you have to share it with them?
You want me to take that?
Sure. I'll take that. Look it, we know that when you're in this case, what we've described as 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. Epion is one of those competitors. We'll continue to watch as they come out, and we'll look for their data. We think just that we have strong data, and one of our distinguishing part of the treatment that we do with Epioxa, we think oxygen is a key component of that treatment in doing the cross-linking. This is something that they don't currently use. That's a couple things we'll watch. We do think that it is potentially a big market, it's not like it's a one winner, one loser as well.
The last thing I'll say on that is we have a, call it a Third-generation keratoconus treatment coming down, you'll hear more about that. We've talked a little bit about it. We think it's a very exciting, we're in phase II on that, and moving into phase III.
Next year.
Next year. Stay tuned to hear more about that technology.
Great. We're about a minute over. 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.
Hey, thank you.
Thanks for having us.
Sorry we couldn't be there. Take care.