You guys ready?
Yep.
Anytime? Okay. Good morning. Thanks for joining us here at Stephens Conference. I'm Mason Carrico. I'm the Diagnostics and MedTech Analyst here at Stephens. It's my pleasure to host Glaukos today. Joining us from the company, we have Alex Thurman, CFO, and Chris Lewis, VP of IR and Corporate Affairs. Great to have you guys here. Thank you for coming.
Thank you for having us.
Of course. Maybe to start it off here, could you just give us a high-level overview of Glaukos, the focus of the company?
Absolutely. I'll take that. You know, if we think about the company and its history, it was founded upon the idea that glaucoma treatment historically has not been very effective. For glaucoma patients in the past, in the history of the disease, the way that it was treated was traditionally, you would go into a practice, and the doctor would prescribe you a drop. And then when you came back, and maybe your pressures weren't abated, they would just do a second drop, and then a third drop, and even possibly a fourth drop, until such time as they didn't know what else to do, and you would proceed towards what kind of a very invasive and ugly surgery called a trabeculectomy or a tube shunt. And our founders thought there has to be a better way to treat this disease, and it's a sight-threatening and ultimately a blind disease.
And so they came up with this idea of, can we restore the natural outflow of the fluid that builds up on the front of the eye when you have glaucoma, and do it in kind of a natural way? And that was the origination of the iStent that was ultimately, it took about 10 years, but ultimately approved in 2012. And from there, we've had a history of improving those stents. We've had two versions since then, the iStent inject and then the iStent infinite. And other innovations along the way, ultimately, just most recently, something that we'll talk about, I'm sure, a lot today, which is iDose, which again, is a novel idea and a novel product to address the unmet needs of patients with glaucoma.
And then I'll just briefly mention along the way, in 2019, the company bought Avedro, which owned a product that was targeted towards a corneal disease called keratoconus, a rare disease there. And so we've since then been selling that product to address the need in corneal health. And as we've recently disclosed, the second generation of that product, which is called Epioxa, has completed its second pivotal phase III trial, and we're marching towards an NDA filing by the end of the year.
On iDose, could you just talk about the value proposition and maybe the significance of the label?
Yeah, I'll take that. So iDose, for those kind of give a high-level summary, iDose is kind of a first-of-a-kind, long-duration procedural pharmaceutical where the implant is implanted within the eye in the anterior chamber, and it's able to elute drug over extended periods of time, now out two to three years based on our data. The value proposition that iDose brings is there's multiple, but the primary focus is addressing the noncompliance issues of topical medications. As Alex kind of talked about, the historical treatment paradigm has been drops, drops, and more drops. The problem is the drops don't work when they're not taken. And in glaucoma, for a variety of reasons, installation issues, mobility issues, et cetera, cost issues, patients just don't take their drops. And studies continue to show that one in two patients don't refill their first script. Nine out of ten patients are truly noncompliant.
So when you think about that and you talk to people and doctors, they're aware of those issues with topical medications. They just haven't had an alternative to provide a patient in order to take that compliance out of the patient's hands. With iDose, it's kind of the first time you can actually provide that by delivering a well-known prostaglandin, in this case, travoprost, within the anterior chamber for extended periods of time. So that's first and foremost the value proposition. What iDose, we believe, it brings to patients and doctors is that it can address that noncompliance with topical medications. The second one that maybe is a bit more underappreciated at this point, but we're certainly excited about it, is just the chronic side effects with topical medications, especially a lifelong dependency on topical meds.
When you think about hyperemia, which is red eye, 30%-50% incidence rates with prostaglandin topicals. You think about comorbid dry eye disease. More than half of patients on topical glaucoma meds end up getting dry eye disease because of all the excipients and preservatives in those topical meds and the damage it does to the top layer of the cornea. With iDose, because you're going behind the iron curtain, you're able to generally avoid those types of safety considerations. And we've seen that play out in the clinical data. So I think those are the first two that we think about. iDose is obviously supported by a robust set of clinical data that we've accumulated over the years, both through a phase II, that we are out three years now, and a phase III that included two 500-plus patient studies to support our NDA approval.
What we've seen there is that the product lasts out two to three years, where you're seeing 90% plus of patients still well controlled at a year, 70% still well controlled at three years. So the data is strong and supports where we believe we want this product to go over time. From a labeling perspective, it's a broad indication. Ocular hypertension through open-angle glaucoma, so when you think about that, it's the broadest label we've ever had, addressing the largest market we've ever had because you're not just tied to combo cataract surgery like we have historically. So you think about just the prevalence of that, 20 million eyes in the U.S. or more with ocular hypertension or open-angle glaucoma, more than half of those, 10 million plus, are being treated in some form or fashion today.
You compare that to where we were with the combo cataract market, which was a great market for us and really a beachhead market to support the evolution of our company, but that was a 500,000 to 600,000 annual procedural market in the U.S., so just magnitudes bigger in terms of where we are hoping to go and ultimately kind of support our strategy to really kind of change and improve the treatment paradigm and glaucoma to more of an interventional, earlier intervention mindset, and we're just in the very early innings of that.
Maybe you'll look at just their update us on the reimbursement side of the equation to hit on that. The J-code's been established. You're working through the pro fees with the MACs. Are pro fees still a concern with operating surgeons at all? Where does surgeon confidence kind of shake out on all of that?
Yeah, so let me level set. Again, there's three phases to the reimbursement with iDose. The first is to get the facility fee established, which thankfully we did on April 1st. So that piece is handled. The second piece is the J-code, the permanent J-code. And as we had set our goals, it did become effective on July 1st, so the beginning of the third quarter. Then the third piece, or the third leg of that reimbursement, is to get the pro fees established. And we're still in process of that. And that's on a MAC by MAC basis. And the key to the reimbursement, and what's so interesting, is that the physicians, the surgeons, are very excited about iDose. There's a lot of clinical excitement.
I'm sure investors who have done their checks can hear from doctors how excited they are because it addresses all these unmet needs and the things that Chris was talking about, taking patient compliance out of their hands, and also, surgeons know that the drug works, right? Travoprost works, and so there's excitement there. What has been the gating factor is really around this reimbursement confidence that you mentioned and the back offices. It was interesting to see how practice CFOs or revenue cycle managers in these practices were really gating their surgeons on implementing iDose until they were able to see the reimbursement come through, and so that's been a process, and that's been something we've taken on over the third quarter and starting to get those MACs to unlock. And for those of you that aren't aware of how this process works, it's fascinating.
So when you start to submit a claim under a new J-code, every MAC, of which there are seven, will assign that claim to a person, an individual, who then adjudicates it on a manual basis, one by one. And then as claims come in and volumes increase, ultimately, that MAC will get tired of assigning it to the person and the caseloads, and they'll just say, you know what? We've seen enough. We're just going to automate this. And at that point, the J-code and the facility fee gets paid automatically. Joe likes to say it's a press of an easy button. And then the pro fee, right? Ultimately, the pro fee's same idea, where a case manager will crosswalk that procedure to some other glaucoma or some other procedure and pay a pro fee. Then ultimately, we want those pro fees to be consistent.
And ultimately, the goal would be to ideally have it on a pro fee schedule. Right now, of the seven MACs, we really only have one, Noridian, that's on the easy button phase, and they have a pro fee schedule. We've got another one that's right behind them, and it's very close. We've got three more that are, we'll call them in the middle tier, where they're coming along, but there's still some work to be done. And then the two that are kind of, let's say, lagging, but they're the smallest geographies. And since this is a volume game, you can expect that those smaller geographies just need to have more volume to get there. So we're getting there. We're starting to see the unlocking, and we're excited about it, but that's kind of the process to get reimbursement confidence.
Compared to this whole process with Medicare, when it comes to the Medicare Advantage patients and commercial payers, how important is that to surgeon confidence?
Yeah, it's an important piece over time, for sure. Our initial focus out of the gates, as you know, has been Medicare fee-for-service, just because that's the cleanest from a reimbursement perspective. Maybe taking a step back and providing a little context on the different buckets, because I think that might be helpful. Historically, our iStent utilization, if you will, in combination with cataract surgery, was weighted about 80% Medicare, 20% commercial. Because that was tied to cataract surgery, and cataracts often are a little bit later in a patient's life, you could see that move up a little bit. In our phase III studies, it was almost a 50-50 split between Medicare age patients versus commercial age. So you could see that come a little closer to that over time, assuming we're successful in driving earlier intervention, especially.
80%-20% is probably a good place to start as you think about the Medicare versus commercial split. And then within the Medicare, just nationally, the split is about 50% fee-for-service, 50% Medicare Advantage. So our initial focus upon launch for really reimbursement reasons has been on that Medicare fee-for-service population that has a supplemental or secondary type plan from a co-pay or co-insurance perspective.
I know we're still early here, but as much as you're willing, could you talk about the patient population mix in terms of what you're seeing with iDose so far, how that kind of shakes out at this point?
Yeah, as Chris mentioned, our primary focus this year has been on Medicare fee-for-service. And we've done that by design because that allows for a very clean claim adjudication process. So I described earlier how the MACs work and how they adjudicate these claims. And when you have a Medicare fee-for-service, 90-plus% of those patients don't have any kind of out-of-pocket. They're covered by a supplemental policy or something. So it's very clean for the patient, very clean for the practice. And typically, we've encouraged practices to do it in a standalone setting. So we focused on that this year. And then, as Chris was mentioning, the goal will be next year to start to open up the commercial patient mix and then Medicare Advantage following on that.
Okay. And maybe in terms of the types of patients, where are they kind of in the glaucoma clinical care pathway, if that's the best way to describe it? How is that looking?
Yeah, it's still early, as you can imagine. And each surgeon is a little bit different in terms of their treatment algorithm. Glaucoma patients are typically in a practice for 20-plus years, and there's no cure to glaucoma, which is an important aspect to think about and remember. So it's really about trying to manage the disease and slow the progression over time. So from that aspect, it's been used thus far based on our understanding across a variety of different kind of patient subsets. I'd say, not surprisingly, a couple of the, I think, gateways to adoption that we've seen emerge more so have been just patients that have already had an interventional glaucoma procedure.
So whether that's an SLT, which is a laser-based procedure, nearly a million of those done a year, or perhaps a Durysta, which is another it's a biodegradable implant that lasts three to six months, let's say. But kind of the doc has already had that interventional glaucoma discussion with the patient. The patient's been comfortable, perhaps gotten off a drop for a period of time and doesn't want to go back. The problem hasn't been they just haven't had a solution for that next step, and now they do. And so I think you've seen a lot of that be a pretty synergistic way, especially in these early days, for that.
I think over time, you'll continue to see that evolve into patients, the things we've talked about, patients that are just known to be non-compliant, patients that are on two or three meds but just continue to progress, patients with mobility issues. And then, obviously, from a setting perspective, obviously, primarily being done, as Alex talked about, in standalone. But over time, from a clinical perspective, patients with comorbid glaucoma with cataract surgery, obviously, that market's been built by us over the past 10-15 years. From a clinical perspective, it makes a lot of sense. And you'll probably hear that from doctors as you do your checks as well.
Are there any specific drivers that unlock utilization in the combo cataract setting? What gets utilization going there?
I think from a clinical perspective, like I said, it makes a lot of sense from the complementary mechanism of action standpoint. You're already in the eye. Typically, they're probably already doing a MIGS for most of those patients, if not all of them. So why not either replace it with an iDose or add an iDose into maybe another MIGS procedure you're doing? So I think organically, you'll see that. Our focus, as Alex talked about, has really been on the standalone side of the house thus far as we kind of build the foundational building blocks on the reimbursement pieces. But I think as we move into 2025 and certainly beyond, you'll just organically start to see that. And we have already. I mean, there's been doctors that do that, and that's at their discretion, and that's perfectly fine.
And so there's nothing per se to restrict that right now. And then, of course, as with all of our products and technologies, we'll have a variety of phase IV studies that we're already doing, including one iDose in combination with cataract surgery, just to have data to support that long-term utilization across a variety of procedural types and setting types.
When we do think about it in the combo cataract setting, what would I mean, I think it makes a lot of sense for them to be used in combination in addition to instead of replacing it. But I mean, do you think there will be some cannibalization of iStent? What would drive that decision to use iDose instead instead of in addition to?
I think, I mean, certainly, there could be. And I mean, I guess, quite frankly, if we were to replace our stent business today with an iDose on every one of those, I think all of you would be happy because the price of an iDose is 10x what it is of stent. Now, that being said, to Chris's point earlier, the stent and the iDose have two different complementary mechanisms of action, right? The stent is to increase the outflow of the fluid, and the drug in the iDose is designed to stop the inflow, right, or slow it down. So they could be used indefinitely together. And as Chris was mentioning, we want to provide data or have data available to support that use if ultimately we get to that place.
Okay. On the Q3 call, I think you guys noted that you had expanded access to iDose to the entire sales team. Could you just remind us how large is the commercial team today? Are there plans to expand headcount? And how are they really splitting their time?
Yeah, so our direct rep base is kind of in that mid-60s, close to 70, I think, which has been generally pretty stable around there for a period of time. We've obviously invested a lot around that from a reimbursement liaison perspective, payer access, market access perspective to support all the various dynamics with the launch. And I think you'll continue to see us drive those investments over time. The way we've kind of laid this out or evolved the launch has been right in line with our plan, being a methodical controlled launch building over the course of the year. So just to kind of remind investors, we started with 15, a group of 15 docs in the first quarter, and we expanded that to the full sales force iDose that is in the second quarter.
And then, obviously, since then, it's continued to expand from a surgeon training perspective. iDose is one of the most straightforward procedures we have. So between that and the surgeons being comfortable working in the angle because of MIGS over the past 10 years, surgeon training is not the barrier here. It's, to Alex's point earlier, it's all about that reimbursement confidence pieces, accounts seen, payments come through under the J-code, professional fees getting established. That's more of what's kind of gating right now rather than the surgeon training aspect. So we feel like we have plenty of coverage. If you look at the larger IOL franchises from the J&Js and Alcons of the world, they probably have 100-125 core reps doing billion-dollar-plus type franchises.
So it's a very leverageable kind of rep channel in ophthalmology, which is a little different and unique versus maybe other areas of med tech.
So maybe on the iDose readministration opportunities, I think when you guys ask about it, you're in conversations with the FDA. You often point to TREX as an option for a second iDose. But I guess just thinking about the two, how much of a priority? Where does the readministration of iDose rank in your priority list there?
Yeah, I don't know that I'd actually rank it. I mean, it's an option for us. The way to think about it is we designed the trial, the pivotal trial that had a cohort of patients that we did readministration into. We submitted that to the FDA back when we did the original application for approval of iDose. Given the time, there were some time constraints, and the FDA wasn't really able to focus on it at that time. So we went ahead and had them finish out the process, got our approval, and now we're reengaging with the FDA. We're taking that same data that we did and kind of cutting it out of the NDA application that we submitted and kind of repackaging it for it.
And we've delivered that to them, and we're now in discussions to go through that data with them to try and see if they will go ahead and relabel it to allow readministration of the original iDose TR. Now, that being the case, we have a second track, right, which is our next generation iDose or what we call the TREX or TREX.
TREX, maybe that's a different.
TREX extended, so TREX. And the timing on that should be somewhere in the late 2027-2028 timeframe because we'll plan to enter into a phase II pivotal trial soon. And if you think about when the patients that are right now or early next year getting their iDose TR and if they're able to spend three years on it, which is what 70% are able to do, then they'll be probably eligible for the TREX once that gets approved in that hopeful timeframe. So we've kind of got those two strategies working. And we've shared with you that we're in the middle of these discussions with the FDA. We're not going to give a play-by-play book on what those discussions are like. But we'll continue to update investors on each call and where we are in that progress.
We're, I guess, hopeful, but we're not counting on it, I guess. Is the end of that.
Got it. And how should we think about a timeline until maybe we have an answer from the FDA?
Yeah, I don't think there's no statutory time frame for that. So it's just ongoing, unfortunately, or fortunately, however you want to think about it. It's a government entity. They take their time. It's not a company. You submit something, and you get an answer within a week. It's the FDA. You tend to submit something. They schedule a meeting with you. Instead of a week later, it's like two months later, and then we just go through the process.
Got it. Okay. Maybe touching on the iStent portfolio here. We're heading into the fourth quarter. Maybe just touch on some of the dynamics you're seeing there and what we should take into consideration as we head into 2025?
Yeah, I think I'd first start by maybe looking at the first three quarters before we count on the fourth. And that is we've been really pleased with the strength of the iStent franchise in the U.S. over the first nine months of the year, growing in the first half, mid-teens and a little bit below that, but still solid double-digit type growth from your perspective in the third quarter. And so that's really been led by iStent Infinite and the continued adoption of that primarily in the standalone setting as we continue to drive the early stages of interventional glaucoma treatment and mindset. And so I think we've been really encouraged with that as we think about where that goes as we go forward.
I think on the margin, as we've talked about on the call, human nature-wise, as reps continue to focus on iDose in an increasingly so manner, you could see a little bit of impact on the iStent franchise just from a time focus. That said, I think we continue to be pleased overall with the opportunities there, especially iStent Infinite as you think about the use case there by the label for patients that have failed prior or failed medical and surgical therapy. There's probably 200,000 annual procedures out there done today, whether that's tubes, trabs, or a XEN, that are all really, really, we think, attractive use case scenarios for doctors.
Given the favorable kind of risk-benefit of iStent infinite, what the data showed in a really sick eye population in the pivotal study, why would you not slot iStent infinite right ahead of those patients before you do, like Alex talked about, a really invasive tube or trab that carried pretty high failure rates over a five-year period? We think it makes a lot of sense. We think that's starting to resonate, and hopefully, that continues going forward.
Nonetheless, during this call, I think you called out increasing competition internationally. Are there specific geographies where you're seeing that specific competitive product?
Yeah. And I'll say before I answer that question, I think it's important to call out another item that we had, which was we really actually had a very favorable renegotiation with the French government on the rebate that we paid to them. And that started this year in January 2024. So part of the growth has been the fact that we've been able to reduce our rebate. And as we go into 2025 and we lap that benefit, right, that will be a little bit of a headwind to us. And then furthermore, as you mentioned, there's some competitive pressures that we anticipate in 2025, as we mentioned on the call. And those are around two of our larger markets, which happen to be France and Japan.
What's happening there is Alcon has been able to those two markets take a little longer to get into, but they're to the point now where they're able to introduce Hydrus into those markets. We expect to have some competition there over the next year. Those are kind of the competitive pressures that we're seeing.
ot it. And then, right , getting towards the end here on the pipeline, can you talk about what you're doing to expand iStent infinite? When should we expect a readout, a potential submission to the FDA?
Oh, yeah. So on that one, I mean, I guess what we've said is our goal is to continue enrollment in that phase III pivotal trial. And with the data readout, we don't have a timeframe for that yet because we need to complete enrollment. So we'll continue to march towards that completion of enrollment. We think that today, the indication is for more advanced patients and that there's a lot of patients in that mild to moderate market that can benefit from the use of iStent infinite. And we just need to be able to get approval for that and be able to market it.
Got it. And then longer term, looking at iLution or really anything else in the pipeline, I mean, what's the most exciting opportunity to you guys?
Yeah, I'll start. I think, well, first and foremost, just from a cadence perspective, the next kind of pipeline, I think, milestone or catalyst will just be our next generation corneal cross-linking therapy called Epioxa. So we just announced positive second phase III data set a month ago now. And so we're on plan to get that NDA submitted by the end of this year and hopefully get a PDUFA date approval decision in the fourth quarter of next year and then launch that at some point in 2026. We're excited about that for a number of reasons. So that is, like Alex was talking about, that it could represent the first FDA-approved truly non-invasive approach to treating keratoconus, which is important because the procedure now, while it's effective, you have to debride the top layer of the cornea.
So the patient recovery aspects and patient comfort and time associated with the procedure, all of those things should be significantly improved with Epioxa in the next generation. So we think it's an important advancement for patients and for doctors over time from that aspect. And then the second aspect, it allows us to launch that in the appropriate avenues and methods from a market access perspective and really the value that therapy brings to the market over time. So we're certainly excited about that. And I think that's a maybe underappreciated aspect of our opportunity here in the near term or medium term from the investment community.
Then, as Alex maybe talked about it more, we have a really broad pipeline that we're continuing to fully invest in, 14 publicly disclosed pipeline programs across five platforms and really differentiated shots on goal with iLution being the transdermal cream platform. So looking at a variety of different drugs and indications there, just entered into a phase I human study in retina. So bioerodible retina program for wet AMD, where we saw in preclinical rabbit models that should be hopefully pretty translational, nearly two years of duration compared to the anti-VEGF, obviously standard care injections. So one to three to maybe four months now. So that's obviously a very early but exciting shot on what is the largest market in ophthalmology.
And then beyond that, there's a variety of things under the hood that we haven't talked about that, as we say, the beakers are swirling in the bowels of the organization, and that definitely has continued.
That's great. Any questions from the audience before we wrap up here?
As we look forward to the TREX trial starting here at the end of the year, could you just comment on the observation period? And then, is there a mechanism at the end to more specifically address the issue of retreatment?
Yeah. Well, I think we'll probably provide you more on that when we actually enter into that trial in terms of especially on the retreatment aspect. But our working assumption is that it would be follow the blueprint of any gold standard drug trial, including iDose TR, which is three months on the primary efficacy endpoint compared to non-inferiority topical timolol. Every drug has followed that pathway. It's a pathway that iDose TR followed, and then a one-year primary safety follow-up, which would be the gold standard for those.
Are you trying to include something to address retreatment in that trial so that it doesn't sneak into the label?
That would be our goal.
Our goal would be to take any learnings from these discussions that we're having with the FDA on TR and incorporate them into the TREX trial if needed.
Hi, George.
Hey, George.
Yeah. Regarding the pro fee, no, first of all, let's talk about the J-code. So it was put in place in early July. And my understanding is then the insurers are going to collect all the data, then calculate the ASP so that the ASP is in place. I think it's from the beginning of October. If that is, could you flesh it out for us?
Sure.
I mean, that seems to iron out one wrinkle. So if you can flesh out and then the program.
Yeah. Interestingly, so once we started this product, iDose, we had to file with CMS every quarter an ASP report. And so after two quarters of that, it gets formally published alongside the ASP J-codes. I'm sorry, the J-code, the ASP gets published. So that did happen in October. And so alongside our J-code is a formal ASP, and it's just part of the reimbursement where accounts will get J-code reimbursement plus ASP plus 6%.
Yeah. So that little uncertainty is removed.
That's correct.
From the doctor's point of view.
That's correct.
Now, on the pro fee, one MAC, Noridian, has an easy button already set up. I think Novitas is close behind. And then there are three guys you said that are kind of in the middle. So generally speaking, I know nobody knows for sure about the future, but generally speaking, in a similar situation, how long does it take for the second batch of the MACs to have the easy button pushed? And then finally, how long does it take for every seven MAC to actually be in place to have that button established?
So I'll start, and if there's anything I forget, Chris, help me out. But I mean, George, I'll point to two things. The first thing is I'll point to our experience with iStent and the inject and that timing, where we noticed it took about nine months, right, to get that pro fee established and kind of pain. And the goal here is to get it paid consistently, not necessarily on a pro fee schedule, although that's ideal. But in fact, one of the MACs has never put the iStent pro fee on a schedule, a formal schedule, but it pays consistently every time it gets billed. So that's the ultimate goal. And I think, as I was mentioning earlier, it's all a volume gain.
So it's a matter of the volume of claims coming into that particular MAC such that they get tired of adjudicating it on a one-by-one basis, taking too much time of their case managers, and they just decide, "Okay, we're going to pay this at X rate." And ultimately, if they decide to, we'll even publish that on a pro fee schedule. So as you can imagine, as you mentioned, Noridian, big, big geography there, right? High volume. So it's the first one to get there. And over time, we expect the rest of them to get to that same spot as well.
And just because, yeah, to Alex's add-on, just because it's not on that pro fee schedule doesn't mean they're not paying. So we're seeing pro fee payments across all of the MACs today. There's just more variability in those laggards, as you can imagine, versus where Noridian and Novitas and maybe a couple of the ones right behind that are.
Now, have you seen, let's say, the doctor's adoption of the iDose in terms of the current trajectory has affected significantly once the easy button has been established? Before and after, is there a significant difference?
I would say yes, there is. And so what we see is in those geographies like in Noridian, our reps have been able to increase the utilization among the accounts there because of that reimbursement dynamic. And so our hope and our expectation is over time, as there are other six MACs that are still lagging, get to that same point, it really starts to unlock the opportunity.
Anyone else? All right. Thank you, guys.
Thank you.
Thank you all.
Appreciate you coming.