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43rd Annual J.P. Morgan Healthcare Conference 2025

Jan 15, 2025

Lilia Lozada
Research Analyst, JPMorgan

All right. Hi, everyone. Thanks for joining. I'm Lilia Lozada. I'm on the MedTech team here at JPMorgan, and I'm happy to have the Glaukos management team with us here today. I'll pass it over to CEO Burns for a presentation, and then we'll jump into some Q&A afterwards.

Tom Burns
Chairman and CEO, Glaukos Corporation

Okay, thank you very much, and good evening and thanks, everyone, for joining here tonight. I'm delighted to give you an update on Glaukos Corporation, and then after this presentation, myself, Joe, and Alex are happy to answer any questions that you may have. At Glaukos, we're in the business of creating entirely new marketplaces within ophthalmology. We've embraced this culture of "we'll go first," and innovation is at the core of everything that we do, and that innovation is largely directed on the creation of dropless therapies to change the convention and the practice of medicine against these anterior segment diseases, to revolutionize it and to be able to advance patient care. Once we have approved products, these go into the hands of highly capable global sales and marketing teams that have already proven that they can develop and create new marketplaces.

We're focused on five different platforms: iStent, iDose, iLink, iLution, and Retina XR. And these are then going to be transposed against four different therapeutic areas: glaucoma, rare disease led by keratoconus, anterior segment pharmaceuticals, and posterior segment pharmaceuticals. When you think about these platforms, they already are working well on our behalf. They're spawning generations of growth. So if you think about iStent, iStent's already spawned iStent Inject, iStent Inject W, iStent Infinite. iDose TR already has an antecedent behind it called iDose TREX , which we began a clinical trial just in December and has a third generation behind it. iLink, Photrexa, Epioxa will be approved at the end of next year, and we have a third generation behind there. iLution has four different APIs that we have in this cream to be able to advance transdermal treatment of ocular disease.

Finally, Retina XR, if we're able to create that bioerodible, we think that it has legs as well. So we've spent $700 million just since 2018, and that's yielded 14 different disclosed pipeline programs. So think about that: 14 programs, many others that are under the hood that have yet to be disclosed. And we only had four of these just a decade ago when we went public. But our key opportunity is exploiting the commercial opportunity that's in front of us today, and that's how we'll build value in the corporation. So we're going to be principally focused on creating this interventional glaucoma marketplace and exploiting the opportunity, the revenue opportunity between iDose TR, iStent Infinite, and then next year with the launch of Epioxa, moving into this iLink O2n and exploiting that new treatment as well.

We are into disrupting the status quo, and we've done so already. We were the company that pioneered, created, built, and currently leads the global MIGS marketplace. We're going to do the same thing as we build this interventional glaucoma marketplace. And interventional glaucoma in and of itself addresses the drawbacks that are associated with topical drop therapy. And mainly is that while topical drops work in clinical trials, they don't work very well if patients don't take them. And we know from multiple prospective and retrospective studies that the rate of noncompliance is ubiquitous. Some studies show as great as a 90% noncompliance rate with directed therapy. 50% of patients discontinue therapy after six months. What that leaves then is the progression of glaucoma and leads to blindness. And there are several studies that show that even patients that are diagnosed and under treatment with topical drops go blind.

When patients do manage to get them into their eyes, they cause a number of different sequelae: hyperemia, periorbital fat atrophy, ocular surface disease, and hyperchromia, and so there has to be a better way, and yet the current standard algorithm is based on these topical medications. They dominate the treatment of glaucoma in the marketplace. Surgeons and clinicians start with a single med. They add serial meds as they go, and then they'll turn to typically laser procedures and more draconian end-stage filtration procedures like trabeculectomy and aqueous shunt, so we are advancing the concept of having these surgeons cross the Rubicon and to start to do these procedures far earlier in the intervention of glaucoma where they can shut off the progression of the disease and do so typically in a 24/7 manner where they don't have to worry about noncompliance interrupting patient care.

We think that the principal catalyst behind this will be products like iDose. iDose is a really remarkable product: 15 years of development to get this product into the marketplace. Many of you who followed us and tracked us have been watching this for some time, as have we. We were able to take an ultra concentrate of travoprost, place it in this tiny device, and get it to elute at a constant micro-elution rate to achieve therapeutic index in the eye and be able to effectively treat patients with minimal side effects and provide 24/7 compliance. A huge undertaking and a phenomenal success. One of the things we did, which we were the high advocacy against, was to anchor this several years ago because we worried about a bioerodible bouncing around in the angle and causing endothelial cell damage.

We happen to be a little bit prescient there when we look at the current bioerodibles that are available. Our product is anchored, and we see really de minimis amounts of endothelial cell loss. iDose will be the workhorse. One of the reasons that I'm excited about this product is we were able to get a 505(b)(2) designation. It has the same label as topical eye drops, so you can use the iDose with ocular hypertension patients. These are patients with high pressures that don't yet have any optic nerve damage all the way through late-stage glaucoma. It will be our principal workhorse, a workhorse, and a foundational therapy for us.

And then, of course, it's anchored by the mechanisms of iStent Infinite for patients who failed on medical and surgical therapy, and as well as iStent Inject, which has a labeling claim for use in mild to moderate open-angle glaucoma in conjunction with cataract surgery. These products will form the basis for how we change this paradigm. I'll get into this as we go further. Get surgeons to cross the Rubicon, do SLT. SLT, in many cases, will fail after a number of years. These products become principal advocates of next-stage therapy in the long-term treatment of glaucoma. We've done, I think, a reasonably great job with iDose TR since we've had it. We got approval in December of 2023. We launched it early in 2024, and we were able to commit and to achieve a J-code in July.

We've been working hard with the MACs and making some significant moves in moving the dial and getting reimbursement for professional fee and for facility fee as well as for the drug. Our opportunity in the second half will be to be able to be opening up reimbursement and being able to go into commercial payers and Medicare Advantage payers. Once we start to get true traction both in training surgeons and getting reimbursement, we will then be able to put a tremendous resource of marketing behind this to be able to drive adoption. Likewise, iStent Infinite, we were able to get an approval to move up to APC 5493. That was done through tremendous work in establishing a geometric mean that allowed us to go into a whole new different APC level, far more profitable for facilities to use this product.

We established all professional fees at max by the end of the year. I think one of the important things is in the course of 2025, you'll see we've done a level one comparative control study comparing iStent Infinite with Hydrus, and we came up with some supremely favorable results in support of iStent Infinite. One of the concepts that we're trying to drive is this concept of IG in the forever patient. As you know, glaucoma, once diagnosed, is a disease that will take you through the end of your life. Most averages, when we do studies, show that patients who are on either have ocular hypertension or glaucoma live 20 plus years with the disease.

Our concept is to take these patients, convince surgeons that they can have these patients stick with them through the continuity of their patient journey, and to use a continuous application of these micro-invasive injections to be able to liberate patients from these drugs and to prevent them from having these draconian end-stage procedures. We think we can flatten the trajectory of what happens with the progression of glaucoma and improve patient quality of life. One of the things we found is that if patients do these procedures, our surgeons do these procedures, patients are sticky. They tend to engage a lot more in the therapy and to stick with the practice. In doing all of this, I think we're going to create such demand that the capacity constraints on ASCs will be overwhelming. We hope they become that.

And that's why you've heard me talk about moving these principal injections into the office over time. So we're not only coming up with different devices and applicators to get us there, but we're also going to be doing the hard work of working with MACs to make sure we get reimbursement for in-office procedures. In this concept, the OD becomes increasingly important. He or she becomes the principal caregiver, works up the patient, and follows the patient. I think one of the things I wanted to leave you with is that for some time, surgeons in ophthalmology have spent their time, resource, and efforts trying to attract cataract patients and refractive patients into their practice. It's the lifeblood of their practices. And yet in doing so, these are one-and-done procedures. And so this is kind of a catch-and-release mentality that I think needs to change.

Think about if surgeons were able to turn their turrets to the hundreds, perhaps thousands in many cases, glaucoma patients that they have in their practice and started to treat them consecutively with these microinvasive procedures. Not only are they raising the level of care and preventing progression of disease, but it becomes a principal and important and paramount financial opportunity for surgeons. I think we're going to drive this concept, and I think this will carry and resonate with surgeons as we go forward. So watch what happens over the next 10 years. Of course, you need good data to make that happen, the confidence of the surgeons. You've seen some of this data. This is the data from the Phase 2b where we showed that almost 70% of patients at three months were controlled on the same or fewer medications.

We then validated that with our phase lll data, 1,150 patients showing at 12 months that 93% were controlled on the same or fewer meds, 81% on no meds, even though 23% started at baseline on two or three more medications. And so we just released today some highly validating evidence of the pivotal trial, the two pivotal trials that we did that showed that 70% of those patients were controlled at three years. This is fabulous data. This will resonate with surgeons as you do your channel checks. This will be highly regarded, particularly when we see how superior this is versus timolol therapy, which in many cases has been the standard of care over the period of time. I think what's exceedingly important as well is because you're behind the iron curtain and the cornea and you're delivering micro-elution rates, you also have principally minimal side effects.

And so at the three-year time point, we found no adverse events of periorbital fat atrophy, very low rates of conjunctival hyperemia. We found no adverse events of corneal endothelial cell loss and very low incidence of iris color change. And so you look on the right of what happens with topical PGAs, and this is an insurmountable difference of being able to put this tiny micro-elution rate product inside the eye. The power of combined therapy has already been embraced by clinicians. When you think about it, when they do topical medications, over 50% of patients are on two or more medications. And that's because surgeons believe that by combining mechanisms, they can lower target pressures to be able to principally prevent the progression of disease.

To me, it just makes entire sense that as we launch iDOSE over time, surgeons will start to pair it with different MIGS procedures. It's going to happen. Many surgeons, as they enter, are going to say, "Look, Winston, I'm placing this in your eye. It makes sense that I'm going to place this plus another device in your eye to give you low target pressures and prevent the progression of disease." They're also pairing it with procedures. There have been a lot of comments about, "Will iDOSE be used with cataract surgery?" There's no doubt that it will. We've done a study outside the United States where we looked at iDOSE in combination with cataract surgery. At the six-month time point, we're seeing 44% reductions. These are phenomenal reductions in intraocular pressure at six months, 11.3 millimeters reductions from baseline.

Again, this will resonate with surgeons as we bring this out and publish this data. So how big is this market going to get? Well, it's even hard sometimes for us to try to compute where this market is going. But if you think about it, we've built a business on the left end of this slide looking at MIGS plus cataract with 500,000 procedures per year. So it bodes very well. We become highly optimistic if we're looking at patients and a 12 million number of eyes of patients with diagnosed and treated glaucoma that we could do exceedingly well and the world is our oyster. If you look at these different patient groups, each one of these patient groups that I think you would argue is a palpable reason to use an iDose, each one of these is a robust TAM in and of itself.

We have high prospects for where this will go over time. And of course, we've created a roadmap which allows us to get there. You've heard me talk about for some time how we wanted to be able to control and present products that would represent the full range of glaucoma disease stage severity. And we've done so. You see this map here. A couple of points. iStent Infinite, we continue to enroll the clinical trial to expand its label and standalone open-angle glaucoma with mild to moderate patients. We'll begin by the third quarter of study with , which is kind of the end cap for refractory procedures. And as we talked about, we were able to on time begin our clinical trial with iDose TREX.

Importantly as well, we finished a trial, second phase clinical trial with the iLution travoprost, and we're assessing the data as we speak. So this portfolio commands at every level the ability to provide the best benefit to risk ratio for patients at every stage of disease stage severity of glaucoma. So we're going to build this interventional glaucoma marketplace. And we will over the next 10 years. And in doing so, we're going to induce change. So this is our prescription and prognostication of where we go forward. First, I believe, and we believe the majority of ophthalmic surgeons will choose to adopt the IG algorithm in some form during this 10-year period, where now it's just a fractional amount that currently are using this. We believe that iDose therapies will continue to and will increasingly compete with SLT for first-line therapy.

SLT will always be the first-line therapy where they turn to as they go and as they look across the Rubicon to do interventional glaucoma. But we think that iDOSE will increasingly command a representative portion of that position. Combination therapy will and has the potential to become a preferred form of therapy over time. It's just commonsensical. And if you talk to surgeons, they're already going there independent of Glaukos. I think consistent reimbursement, surgeon confidence, patient preference, and new innovations will drive in-office therapy. So I've talked about this for some time. This is not going to happen overnight, but during the planning period, we'll start to drive interventional glaucoma therapy in the office. And we're already working on scale-up provisions to approach MACs to seek reimbursement. These new therapies and sustained-release drug products such as TRX are going to continue to fuel this marketplace.

It just makes sense. The more I can give you with a single injection, I think it's going to be attractive for patients to have this procedure. Private equity groups who are continuing to command a larger portion of the landscape are likely to gravitate to interventional glaucoma therapy, not only for the significant clinical benefits, but this is a powerful and paramount financial advantage for PE groups over time. And finally, I think most importantly, I think a new breed of specialists, IG specialists, could emerge that will primarily conduct injection therapy with vertically integrated ODs and OD referral networks providing preparatory patient services. Why wouldn't this happen? This is happening already on the retinal side where retinal surgeons are spending all day long getting carpal tunnel syndrome, injecting patients with anti-VEGF proteins.

I think this will happen as well in glaucoma where surgeons say, "Look, I do my glaucoma procedure or my cataract procedures on Mondays and Wednesdays, and on Tuesdays and Thursdays, I do my iDose and iStent Infinite injections. On Fridays, I see patients. In the meantime, my ODs are working these patients up and following the patients." Okay? Mark my words. That's where we're headed. And finally, if you think about it, right now there's 4.5 million estimated cataract procedures that happen every year, dwarfs the number of interventional glaucoma procedures. And I believe at the end of this 10-year period that we could be doing as many interventional glaucoma procedures as cataract procedures. The math works. And that statement two years ago would have been heresy. And today it's merely controversial. I think five to seven years from now, it'll be self-evident and inevitable.

In addition to glaucoma, we're also focusing in on rare disease. We've been very pleased with the seamless acquisition and steady growth of our iLink product with the acquisition of Avedro in 2019. We're excited moving forward with Epioxa. Epioxa is the next generation where you don't need to debride the cornea to be able to arrest the progression of keratoconus. Because of that, or that's due to the fact that there's a higher irradiation rate, the fact that there's a proprietary formulation that has a surfactant, and then most importantly, we have supplemental oxygen that's perfused on the surface of the eye during the course of the procedure. By reaching this goal, this is a game changer for the treatment of keratoconus. It's going to improve patient comfort dramatically and increase visual rehabilitation.

It also shortened the procedure time for surgeons to be able to maximize their opportunities within the office, and again, the importance of supplemental oxygen can't be diminished. It causes a Type II reaction, which is far more efficient, throws off oxygen-free radicals, and causes this cross-linking bioconversion. Now, what if we took that same concept and we used biomechanical modeling and corneal topography and customized the treatment of keratoconus for every patient? This is done all day long with LASIK, where we look at corneal topography and aberrometry to be able to dictate how the laser dances across the eye. We have that opportunity to do that as well here.

We're doing this in a phase two study as we speak to be able to create the ultimate spherical cornea, which will reduce any aberrations and allow us to perhaps even improve visualization in addition to shutting down the progression of keratoconus. Exciting stuff. This will be a generation that will come right behind Epioxa. We have a full pattern developed in the rare disease spectrum as well for TREX, Epioxa, third generation of iLink. We also have an iVeena. We acquired a company called iVeena, which has a copper sulfate topical medication. We're interested in to see where this would play in the marketplace. I think this could have a huge impact with optometry, which can't currently do in most cases the cross-linking procedure, and certainly internationally, where we have the ability to have a presence.

We think we're covering, much like we've done on glaucoma, we're covering all angles here and creating barriers to any competitive entry. iLution has been a very, very predominant form with this transdermal elution of active pharmaceutical ingredients. You've seen the data that we've presented with pilocarpine in dry eye, where we're able to increase visualization and tear film stability. I think one of the great opportunities we have moving forward is this area of Demodex mites. Tarsus has done a good job creating this marketplace. It's a condition that affects 25 million people in the United States. These are mites that hang out in the follicles of the eyelashes and create tremendous irritation and crusting of the lids, which is found in blepharitis. What we've done is in-licensed. It's a very, very powerful acetylcholinesterase inhibitor called physostigmine.

And think about the opportunity to take physostigmine and put it into a cream and put it into a cream that will go right on top of these critters as they are husband for their nocturnal sleeps and be able to make a meaningful difference in the treatment of this condition. And so we think we can make a meaningful difference when and if we're able to bring this to the marketplace. And then finally, there's been game-changing, as you know, anti-VEGF proteins that have been introduced into the retinal space for retinal pathology. And the problem with these, as extraordinary as they are, the problem with these anti-VEGF proteins is that they don't last very long, as we know, three to four months. And so this imposes a tremendous barrier on patients. 40% of patients within two years are lost to follow-up.

So once again, we've taken an incredible contrarian approach. We're looking at small molecules that will go into a bioerodible matrix that can be implanted into the back of the eye that could last for months or well longer than months. And so you see data on the right-hand bottom portion here. We're tracking over the past three years the use of these bioerodible devices, which elute axitinib, a powerful TKI, into the eye for the treatment to reduce the leakage associated with age-related macular degeneration. So we think this is powerful. We think once we have this in, we'll be able to tailor the duration by the size and configuration of the device. So that data we have in a phase two study right now, we have an ongoing study of axitinib outside the states.

We're anxious to see if this can truly be a game-changing device within clearly the biggest marketplace within ophthalmology. Think about how we're building the business. We're almost to maturation with interventional glaucoma, as you can see. We've been building that since 2012. We now are embarked on building a significant basis and business within the rare disease segment led by keratoconus. You've seen the collateral products I'm bringing for that, and then we'll have a catalyst of an additional jolt of revenue potential formation as we bring together a coalition of products that are produced from the transdermal use of iLution. We'll need to hire a separate sales force. That's a very special breed of retail pharmaceutical, and that will be happening at the end of this decade.

And then finally, if we're successful, again, terribly exciting, terribly early, if we're successful with axitinib, we're going to need to have a specialized sales force and compete actively in this marketplace, which again is the most powerful marketplace within ophthalmology. So you've seen the list of products that we have. It's formidable. I think I put this up against any company within ophthalmology. And for purposes of this next year, I've talked about glaucoma, but what I'd expect investors to see is we'll be moving forward, opening up a clinical trial with the iLution blepharitis product by the end of the year. And then I expect you'll see data as well from what I believe will be a game-changing third-generation iLink device, which we call Sphere, which is meant to change the surface of the cornea to eventually improve patient vision.

From an operating standpoint, I personally couldn't be more proud of the people that are to my left and what they've accomplished here. 30% compound average growth rates over a 10-year period. From a standing start, we're now vertically integrated in 17 countries around the world. We have over 300 global sales personnel. We've established profit and maintained profit margins of 82%. We've built a facility to make these nanotechnology iDose in San Clemente. And then, as you know, we've talked about as well, we're building a very huge secondary facility in Huntsville, Alabama, which is going to give us increased capability to do aseptic filling. It'll give us the ability to fill these creams and to take on additional products for in the future. I think I've spent a considerable amount of time diversifying our risk as well.

And so nearly 50% of revenue is generated both by international glaucoma and by cornea. And then finally, we've maintained a very, very, I think, powerful balance sheet moving forward. So we have gone first. We'll always continue to go first. And I hope by doing so, we'll become the next major strategic player within ophthalmology. Thank you.

Lilia Lozada
Research Analyst, JPMorgan

Great. Maybe just starting with iDose, we saw today three-year data for the product from your two phase lll clinical trials, which looked really similar to the phase ll data you already have going out to 36 months. So is there any desire to formally have three years on the label, or are doctors basically prescribing that way already given the phase ll data?

Tom Burns
Chairman and CEO, Glaukos Corporation

Yeah, I'll take that one. So the answer is no. There'll be no movement to get a labeling claim because we don't believe we need it, right?

When people see that the data carries out to three years, if you talk to any of your ophthalmologists with channel checks, they will tell you that this product works exceedingly long, many even beyond three years in their hands. I love the fact that we are treated similar to a topical medication right now because that means that our primary efficacy endpoint is at three months, which makes it particularly facile for us to get to marketplace. We'll prove that this lasts longer through phase four data, but I don't need to prove that in a phase three regulatory pathway. If you think about it inherently, some of the leading surgeons in the world have been involved in our studies, and they've seen it themselves, to Tom's point. So you're really not trying to prove that they've seen it over and over again in those clinical studies.

Lilia Lozada
Research Analyst, JPMorgan

The safety profile remains strong as well. So any updates on reimplantation?

Tom Burns
Chairman and CEO, Glaukos Corporation

Yeah, the only update is it's going exactly the way I thought it would. We've appealed the reimplantation restriction from the FDA, and we're in that process. And as I mentioned some time ago, this was going to be a several-month process. It turns out I'm correct. It will be. We're hopeful. But as I've said all along, we are not counting on it. And so that's kind of where we're at. I think we have a sophisticated approach. We've made a powerful argument. Again, from the very beginning, there was no reason why we should have been limited. We think part of that was just the precedent of Durysta, which kind of forced the FDA's hand in their mind. So I think we have the opportunity to change that.

But again, I would say that we are not counting on it. If it happens, it'll be a very, very strong upside for us.

Lilia Lozada
Research Analyst, JPMorgan

You had talked to having facility fees and the J-code processes in a good place with the MACs entering 2025. So did you accomplish that goal?

Joseph Gilliam
President and COO, Glaukos Corporation

Yeah, I think every day we continue to make progress there. What I would say today is that we separate this between sort of the J-code, the facility versus the professional fee, which we can talk about separately. On the J-code, we've made considerable progress. We've talked about Noridian in the past being in a good spot. We've made similar progress with Novitas and First Coast. We're increasingly seeing similar behaviors out of Palmetto and WPS. So we're really down to sort of the last two MACs, if you will, in trying to see that consistent reproducible J-code payments. We'll get there in relatively short order.

Lilia Lozada
Research Analyst, JPMorgan

So that isn't the last step needed, though, with physician reimbursement also important given common ownership stakes in the ASC. The last we talked, you had it on the schedule with one MAC and another reimbursing consistently. How much progress have you made, and how much of a barrier to adoption will this be? And are you on track to have this done in the first half of the year, or is it too hard to know?

Joseph Gilliam
President and COO, Glaukos Corporation

No, you're absolutely right. The professional fee is an essential component of the overall reimbursement paradigm, especially with growing interest from private equity and the like. You have a lot more of the physicians that operate today operating from a more of an employee mindset, and the professional fee is the way that they're compensated. So we've been hard at work at that.

You have to establish the drug first. With that, you're able to drive the volumes that ultimately turn the facility or sorry, the professional fee over. We've seen that in Noridian, where we've got an established pro fee schedule. We're seeing increasingly consistent payments out of several of the other MACs, not professional fee schedules yet. They don't always publish these schedules on a timely basis. But what you try to see is that consistency. And across the country, we've now started to see a consistency in terms of the amount that's being paid. What we want to see is the pace in which they get paid and the more automated nature of that. And we're still in the process of doing that.

But I continue to think with the progress we've made on the J-code and the facility, we should be on the doorstep of turning over some of those on the professional fee side as well.

Lilia Lozada
Research Analyst, JPMorgan

Commercial and Medicare Advantage are two opportunities that you haven't targeted yet. So how should we think about your plans to start unlocking those markets this year?

Joseph Gilliam
President and COO, Glaukos Corporation

Yeah, so we've targeted in the concept that our payer relations team has been hard at work since the day we got approval, and they've made tremendous progress. If you go out and do a survey of commercial and Medicare Advantage plans, you'll find pretty robust coverage policies that are quite consistent with Durysta, for example, today. What we haven't done is really turn that on for our customers quite the same way.

They're obviously more than welcome to pursue those patients on their own, but we really want to establish their confidence within the Medicare fee-for-service arena before we started expanding out. Now, obviously, the commercial Medicare Advantage arena has come with a whole lot more complexity in terms of the execution from an HCP perspective, and we want to be able to support that. So going into this year, we'll start turning that on slowly and methodically with those customers who are best prepared to handle that and then expand that from there as the year goes on.

Lilia Lozada
Research Analyst, JPMorgan

Do you have a sense for if you're mostly seeing standalone or combination usage, and do you think the reimplantation limitation is affecting physician willingness to adopt?

Joseph Gilliam
President and COO, Glaukos Corporation

Yeah, well, I don't think the reimplantation is impacting at all. I mean, actually, we've heard very little bit about that.

Again, I think it comes back to something Tom said earlier. It's pretty self-evident to those who've been involved that it's safe and effective. And from their perspective, it's pretty long-acting, so they'll handle that in the future. From a commercial Medicare Advantage standpoint, sorry, the second part of your question was what from the?

Lilia Lozada
Research Analyst, JPMorgan

If it's affecting willingness to adopt.

Joseph Gilliam
President and COO, Glaukos Corporation

Yeah, I'd say it's not, so you know yes about the combination utilization standalone. So from that standpoint, we're seeing majority standalone. Remember, we asked our customers to keep it simple at first. As you're trying to go through the claims adjudication process, you want to make sure that you're keeping it as simplistic as possible so you know what you're solving for to try to put to rest any issues that may arise.

And so from that standpoint, most of the claims that we see are standalone in nature. It doesn't mean that combination is not happening. We are seeing that done in combination with cataract surgery. We're seeing it done in combination with iStent Infinite, all of which are being adjudicated by the MACs in a similar nature to what we see in the standalone. But the majority of the procedures remain standalone in nature.

Tom Burns
Chairman and CEO, Glaukos Corporation

And one other point, as we think about it, even though there's no imposition with the fact that surgeons, we hear very, very rarely, if at all, any imposition of us not having a reimplantation claim for investors, I want you to know that we do care about that in the long term. And we've already, in a way, have a belt and suspenders approach to go with that.

So I'll tell you the fact that we are beginning the clinical trial for iDose TREX. If you think about it, if that product is available in a timely manner, let's call it late 2028, early 2029, that becomes the de facto reimplantation device for all these patients that will be on iDose. So we're covered whether or not we get a reimbursement claim or not with the current iDose product.

Lilia Lozada
Research Analyst, JPMorgan

I don't expect any great answers on the financial side of things, but I feel obligated to at least ask. We had you generating roughly $25 million of revenues from iDose in 2024. So does that sound about right? That implies a certain exit rate to the fourth quarter, and it feels like things should continue to look up from there as you knock down coverage hurdles and have a full year of the launch with reimbursement on board.

How should we think about the growth trajectory for iDose in light of that?

Joseph Gilliam
President and COO, Glaukos Corporation

You're right. I mean, we obviously wouldn't comment on where the numbers are for the year or the quarter exiting. I'll just reiterate something we've said before, which is we're really pleased with the way things have materialized. Tom hit on several of the key milestones that are foundational for the success of iDose, and we delivered on every single one of those. I think so far, and the results that we've produced this year, they've exceeded both, hopefully, your expectations. They certainly have exceeded ours, and we're proud of the team and what they're accomplishing out there.

I think that translates into an exciting moment for us as we enter into 2025 and hope to continue executing both in the fee-for-service arena as well as, as you mentioned earlier, commercial and Medicare Advantage patient populations. Maybe just asking it another way, we saw a doubling from the second quarter to the third quarter. So is it safe to say that momentum should only continue to build from there? I think you go back to what I said. From that standpoint, if you look at the overall franchise, we've seen a continued acceleration of growth from Q4 of last year into Q1 into Q2 into Q3. We're proud of that continued momentum, much of which has been driven by obviously the launch of iDose.

We think we're just starting to scratch the surface, obviously, of a pretty profound opportunity, as Tom alluded to in the presentation. I think whether it's the fourth quarter or obviously 2025, we think we have a whole lot of opportunity in terms of continuing to build that business in a profound way.

Lilia Lozada
Research Analyst, JPMorgan

Maybe shifting to some other parts of the portfolio. The rest of your glaucoma portfolio has continued to perform really well, both in the U.S. and internationally. One of the drivers of this domestically is likely to be Infinite. What has reception been like to this as your first standalone product?

Joseph Gilliam
President and COO, Glaukos Corporation

Yeah, I think iStent Infinite was, in particular, probably one of the biggest surprises to our year.

We had a lot of confidence around that it had that opportunity, but I think the combination of launching that alongside of iDose as well as the product itself and the intended patient population has driven some strong performance, and we saw that in the context of 10%-15% growth in each of the quarters that we've reported, and we've talked about, obviously, some potential volatility around that. We've talked about that coming into the fourth quarter with the MAC LCDs around combination mix procedures, and so we expect that to obviously have a bit of a dynamic here over the short term, but the product and the opportunity associated with it in terms of treating patients in the later stages of disease is a real opportunity for us, not just in 2024, but certainly 2025 and beyond.

Lilia Lozada
Research Analyst, JPMorgan

How much adoption is coming from your own existing iStent Inject W/iStent user base, and how much is coming from competitive conversions? And do you have a sense for what kind of mix this could settle at and if there's any mixed benefit to this transition?

Joseph Gilliam
President and COO, Glaukos Corporation

Yeah, there's a little bit of mixed benefit, and I think we certainly have gained some market share over the course of the last year. It starts to get a little bit difficult to assess it quite the way you asked. And the reason for that is it's not just about in combination with cataract surgery or otherwise, we're expanding the market.

So if you think about the label in terms of a standalone procedure that's for patients who have failed surgical and medical therapy, there's another couple hundred thousand potential patients at any given time who are progressing slowly towards either a tube or a trab or a XEN-type procedure. And part of our goal is to capture as much of that as possible and hopefully preserve those patients from having to go through a far more invasive procedure like those. So I think we're making a lot of progress there. When we sell it, we don't necessarily know. We just know it's being sold out into the marketplace. And so a little bit of that evidence is anecdotal from our perspective, but we certainly think we're expanding the market and probably taking a little bit of share in the historical legacy combo cataract setting.

Lilia Lozada
Research Analyst, JPMorgan

I think with that, we're almost out of time, so maybe we can wrap it up there. David.

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