Glaukos Corporation (GKOS) Earnings Call Transcript & Summary

And good morning. I'm Joanne Wuensch. I'm the Head of U.S. Medical Technology here at Citi Bank. Absolutely thrilled to have the management of Glaukos with us this morning. We have Joe Gilliam, President and COO; and Alex Thurman, the CFO and we're here to talk about the MIGS market. I think that's -- but maybe other markets too. But I think we should start with MIGS. And what I would really like to do is just sort of level set what you're seeing in the market in terms of growth, competition, reimbursement?

Sure. Well, first, thanks for having us Joanne. I appreciate the opportunity to be here. And -- if you think about the broader MIGS market, first and foremost, it's a pretty transformational period of time. And I'm going to separate out the sustained pharmaceutical side of that for a second. But even within the classic sort of MIGs, stents, et cetera, et cetera, we're entering in a period where the market size is growing pretty substantially, as more and more clinicians start to shift from a combo cataract mindset to a broader interventional glaucoma mindset, which we'll talk about -- and I'm sure. But that opportunity is pretty substantial for all of the industry participants, and we're certainly one of those. So I think we can dive into some of the specifics of what's going -- the puts and the takes around the marketplace today. But the reality is we're operating in a larger and larger market as a part of that. And I think you've seen some of that. So if you look at our Stent business over the course of 2024, it's really outperformed, I think, our expectations and certainly Wall Streets, and the kind of double-digit growth we've seen. I think part of that is the overall halo effect of iDose and everything going on within the business. But a big part of that is just the core utilization of Infinite in stand-alone patients who failed surgical or medical therapy and expanding that market opportunity. And so we're really growing that overall market and our business is a part of it. Now you referenced -- there's a lot of stuff going on in terms of LCDs being finalized, et cetera, et cetera. And I think in some ways, those tend to be a little bit more [ rounding error ] elements of what's going on. I mean they've been playing out for now 12, 18 months. And, I think a lot of our customers have already made their decisions in terms of how they choose their algorithm of treatment. And we benefited from that over the course of last year, and so that continues going into next.

So you launched iStent infinite 1 year ago, and the reimbursement went into place within the last 12 months. How has infinite sort of helped you in this market with a little bit of uncertainty that you started the year with?

Yes. Well, in some ways, coming into 2024, the reimbursement really solidified. So the APC assignment change for the facility fee, some of the professional fees started to get established. Some of the overhanging around uncertainty on the LCD side start to become more clear. And so that enabled -- obviously there's the sales force and our commercial organization to really start focusing on what matters, which is clinical utilization and the why behind the product. And so I think with that as a tailwind, they did a great job in really sort of targeting those patients. And -- from an iStent infinite standpoint, it's a great injector system. You get multiple stents. The data, if you go back and look at the studies we've done on iStent infinite is pretty profound. And so for those surgeons that sort of adopt it, a lot of it is, whether it's been in combination to cataract surgery or ultimately on a stand-alone basis, the results speak for themselves. And it was studied in some of the toughest patient populations out there, I mean failed tubes and trabes and zins and all these types of things and to see the kind of pressure drop and the restoration, if you will, of the traditional outflow system is -- pretty impressive. And I think that's what's resonating with customers.

So some basic questions here. As a 100% of your traditional MIGS transitioned over to infinite or do you have older versions of iStent W or something still going in?

No, W is still very much a meaningful part of our business. So it's continued to convert over. And certainly, that's the case. But even today, we still do a decent chunk of our original G1 business. Now you have some customers, a little more price sensitive and things like that, so you have different layers of pricing as a part of that, and that's part of that utilization. Some like that manual tactile feel of -- of doing a first-generation stent. But increasingly, as time goes on, more and more customers are converting to iStent infinite.

Is there a stage where you just stop manufacturing the older ones? Doesn't become cost effective for you? Or...

Well, there's always a time for everything in terms of sunsetting product life cycles, but I will say that, see we're now on a global business and different markets have different price points and different needs. And so, we utilize these technologies in different ways internationally as well as domestically.

So in the traditional MIGS market, competition has always sort of been there in various forms. I mean what are you seeing? You talked about the halo effect in taking market share. But how are you seeing outside of that sort of your share within the market and the overall health of it?

I think our -- just to put a punchline on the latter part of your question, I think our overall share has been stable to growing. Certainly, as a result you can see that in the numbers. It gets a little bit harder to calculate that because, the market itself is expanding to my earlier point. And I think in some respect -- from a competitive landscape standpoint, I think we've entered into a new phase. And at this point, the way I look at it is I don't care which of the companies it is. We're all fighting a common enemy and that is drops in noncompliance. So our perspective, whether a doctor's algorithm involves our technology or competitive technologies. Ultimately, this is a lifelong progressive disease. And I think we can all benefit in this much larger opportunity that is interventional glaucoma. And so from our standpoint, I think it's entering in a little different phase where you can have a lot of winners in the context of that broader opportunity.

Yes. We had a position yesterday on a panel, who was saying his -- essentially his goal is to take somebody from point A until they die, and just make their lives easier with fewer drops and make their compliance easier. And that there could be serial products that roll through that you can maybe do a traditional -- one product and then move to another product just to keep them going down.

Absolutely. And if you think about it -- the very thing that works against these patients in the [ content ] why they don't take their drops, it's an asymptomatic disease. They don't feel it the way that you feel a knee or a hip, and it slowly progresses. So there's not that daily moment-to-moment reminder to take your medicine. That's inherently the reason why compliance is so poor in the treatment of glaucoma. You can flip that to the point of what your physician on the panel was saying. When you give them relief from that, you're also giving them disease relief, because the same thing works to the benefit. If you've taken the drops away because you're providing that 24/7 compliance through an iDose, for example. Now they don't think about their disease, right? Same thing works for them. And that's pretty powerful. And you think about the average glaucoma patients in a practice for over 20 years. So to his point, being able to manage them with multiple modalities, hopefully, multiple iDose, hopefully, multiple iStent infinite, but I'm sure other technologies, SLT or otherwise along the way -- certainly is the future.

Okay. So you walk me straight into iDose, which is pretty impressive. That took us almost 9 minutes to get to it. I would try to -- really hard to work on the other portions of the business.

We respect your restraint.

Thank you. I appreciate that. So iDose has been front and center and middle of the entirety of the year, and I suspect we'll be there for some period of time. Walk us through a little bit of how the early stages of the launch have been? And what are you surprised by? And what do you like -- yes, we expected that?

Yes. Well, I think, first and foremost, in time, you're looking at a new product launch, you have to start with what's going to truly matter for the long term, and that's the performance of the product. So is it clinically doing what in reproducing you saw in a clinical trial environment in the real world. And with that, I couldn't be more pleased. We couldn't be more pleased with what we've seen. I mean you do your channel checks, investors with their channel checks and talking to surgeons and customers, and iDose is performing exactly as we would hope it would. And it's a profound step forward. To the earlier point, prostaglandins work, they always have. The issue is not about the API. The issue has been that patients don't take them. And so by -- as we've said now for a long time by removing that part of the equation and going behind the iron curtain with a therapeutic like iDose, we're getting the results you'd expect. Beyond that, sometimes, we're so focused operationally on what's next in terms of continue to drive every element of this. at a time like this, it's good to look back on a year and say, "So how did it go? And it's hard not to be proud of the team in every element. If you look at how often and how hard it really is to land each one of these things from the timing of our approval through to -- the timing of APC assignment to the establishment of the J-code to the establishment of the pricing file and the ASP components of that, to turning on these MACs and going through all that process. It's been an exceptional year in terms of what we've accomplished. And I think we're just starting to see the fruits of that labor certainly in the third quarter. And as we move forward here, hopefully, an even more material meaning way.

So just stepping back for a second. I'm a physician, and I heard about this cool thing called iDose. How long does it take for me to get into a training program get changed, be proctored and then incorporate it into my practice?

Yes. It's a great question. And as you can imagine, every practice and every surgeon, it's a very different answer. And where they practice and the dynamics within that have a material impact on that. I will say that the [indiscernible] in the training element of this, so you've been around our story for some time, Joanne, and you'll remember that for first iStent Inject, et cetera, the ability to train surgeons was a rate-limiting items. So you have a sales force and you're out, the ability to get to all these folks and do that. iDose's a little bit different because for the vast majority of these surgeons pretty proficient now in angle-based surgery, whether with our technologies or more broadly. And so from that point, iDose is pretty straightforward. So the training element of getting them good at iDose is not the rate limiter. It shifts a lot more on to the office. So where you want to make sure and where we spend a lot more of our time and some of the rate-limiting steps are that they're good at the billing component of drugs that you code, how to do that, all the little nuances that come into that, that the office staff is getting increasingly good at how they identify patients and the total office call, if you will, around those dynamics. Getting that perfected is what's varying from practice to practice and getting them rolling. And what we're seeing is, as you might expect, the distribution curve of the -- there are those who are already leaning with the interventional glaucoma approach, and iDose becomes a natural extension of that, in which case, there's less effort for our team in terms of getting them moving forward and they're off and running, and others where you're handholding that process along and it can take many months to get them to the place where you ultimately want them in. And what we've seen in the past, look, it took us 10 years in combination with cataract surgery to get to where [indiscernible] it's kind of the standard of care. And I suspect that this will be a 10-year journey on this side for us as well.

10-year standard of care?

Yes. I mean saying we're doing it. We're on the journey, and we're going to be driving it forward as fast as we possibly can. And -- and hopefully, we've got a little bit of tailwind because we've been at this for a while and changing that paradigm in [indiscernible] for cataract surgery.

So the physicians that are picking up iDose, are they your strongest iStent physicians or any of -- let's start there and then I have more.

Not always. So I think the earliest customers are often the customers that you trust in the context of training and they give you feedback so that your sales force is going to be a commercial organization could be that much stronger. -- in the launch. But as you move past that, certainly some are some of our stronger customers, but actually a lot are -- it has more to do with what I'm mentioned before, which is the correlation -- are they in the interventional mindset? They have already been largely doing SLT or SLT in DURYSTA, for example. And now they've added iDose into that paradigm. Now most of those customers, because virtually all of them are our customers, also probably we're doing stenting in some shape or form, but they may not have been our largest stent customer, for example.

So if I'm a physician, and I'm recommending to a patient in iDose, what does the conversation sound like?

Well, that very much has to do with where that patient is at in their own treatment paradigm. So if a patient, for example, has already had cataract surgery and they've already had ocular procedures or if they've already had an interventional procedure of some type, SLT DURYSTA, the conversation tends to be more along the lines of, based on the benefits they've already experienced. One of the things that we've heard pretty consistently from physicians is that patients who've entered into that interventional paradigm, they then want to know what's next. Because at some point, the SLT wears off or at some point, that DURYSTA wears off or whatever other solution they've had. And then they come in and they're like, okay, what's the next doc? Because to the point of what I was saying earlier, these patients have had a bit of a disease holiday or they certainly had their drop burden reduced. They've had all the side effects that are associated with the topical drops -- whether that be dry eye or whether that be hyperemia, the red eyes, they've had those -- a period of relief from that. They want what's next. So that patient conversation is much more about, okay, the good news is there's a newly approved therapy called iDose TR, and they explained that, and that conversion is pretty straightforward. For others, it's more about helping them recognize the limitations and that they're -- it's okay that they're not complying on their drops. You think about it for most all of us we lie on the witness stand, when we're in front of our doctors. Even though it was in health care, it amazes me, right? I mean, they ask you the question, you want to please them. And the same thing is true for these patients in glaucoma. How -- if you asked the question, how is it going, they're going to say it's great, even though they probably didn't refill the prescription. So you have to give them the space to be able to answer honestly whatever their issue is that they hate taking it, they can't take it. They don't like the cost of it. You find where that is because it's in there for 90% of these patients, and then you convert that into an interventional procedure.

Okay. One of the things, I think a number of investors and myself we're concerned about entering the cycle was reimbursement. And can you remind us, please, where you are on reimbursement?

Yes, for iDose?

Yes.

So we break it down into kind of 3 key segments when you think about this. The first is Medicare fee-for-service. And a lot of time and anticipate been on that as of late because that's where we're at in that sort of product life cycle. And what we've said is that when any time you're in the fee-for-service i mean, you're dealing with the Medicare administrators, the MACs, the whole process is getting from that early manual adjudication phase to where it becomes a part of their system. And it's true in any launch we've ever gone through and iDose is the very same thing. And so in that regard, in a couple of the larger MACs, where you see more volume early, Noridian and Novitas, we're in a pretty healthy spot. We've gone through that process. They've looked at all the nodes and the various things, and they've started to systematize their payment of the drug and in some respects to the professional fee as well. That next layer of sort of the Max, the sort of midsize MACs that extend from everything in Palmetto and WPS, NGS, et cetera, we're getting close. We may be there. But it's -- we're not in the chain of custody of these claims, but -- so some of this is anecdotal. But I think we're getting close there on the drug and then the professional fees should follow that in the months and quarters ahead. So we're -- I'll call it the middle innings as it relates to enabling market access in the Medicare fee-for-service arena.

Middle innings...

Middle innings of that.

Is there a state -- is there a stage where you're like we're done, checked off that box?

I don't know in the world of market access you've ever done. And if you've gotten to a place of stability, you're always trying to improve from there. But in the fee-for-service arena, if you've got established professional fee schedules or consistent payment on the professional fee and you've got fairly automated payments on the drug and facility fee, you're in a pretty good spot. And at that point, it becomes just about putting out a little fires that happen because of computer systems or whatever at the individual MAC level. And hopefully, we'll get there. And in the past, this is -- again, this is a normal process for us, that we will.

Want that for Medicare Advantage?

Yes. So that's really the last frontier. I'd probably actually touch on commercial before that. And so what we've said is that both for commercial and Medicare Advantage, we will start to roll that out methodically over the course of next year. Our payer relations team has been hard at work. We actually have pretty substantial coverage already in both the Medicare Advantage and the commercial arena. But you also be prepared to support your customers on that. Unlike in the fee-for-service arena and Medicare Advantage and commercial, you're dealing with benefit verifications, prior authorizations, denials, all that kind of stuff, then you want both the customer as well as your support apparatus to be ready to go. We felt like it was important to establish confidence in the fee-for-service arena first and then move out methodically into that, and that's something we'll do next year. So we're prepared for that, and we're preparing to make that launch, and I think it will be increasingly an important part of our business going forward.

So this year's pay for service. Next year is Medicare Advantage and Commercial?

Yes. I would actually probably say -- this year is the beginning. Next year, if you were looking at the book of business in terms of the decision, I'm pretty confident next year will be dominated by fee-for-service with a layering on of commercial and to a certain extent, Medicare Advantage. And then as you move into 2026 and beyond, you start to have contributions more meaningfully from each of those camps. The reason why I say Medicare Advantage is less is simply because the patient on the pocket dynamics around this. So like we're not any different here than most drug companies. And from that standpoint, on the commercial side, you can provide co-pay assistance that minimize that burden for those patients. But that is -- you can't do that with Medicare Advantage patients and covered lives. And so you rely upon the 10% or 20% of those patients who have low out-of-pocket deductibles and/or those folks who show up in the fourth quarter because they've already had their knees, their hips or whatever else done earlier in the year.

Okay. So if I have to divide up fee-for-service Medicare Advantage and commercial 40-40-20?

So that's a good place to start. And in fact, I think what we've said historically with our stent business was sort of 80-20 in terms between Medicare broadly speaking. And Medicare and Medicare Advantage is 50-50 split. So that would get to your 40-40-20. I think in reality, it probably leans a little bit more towards fee-for-service. So I wouldn't say maybe 50-30-20, and that's a good starting point. Over time, we expect that to shift a bit. If you look at the demographics of the iDose study, -- about half of the patients enrolled in that would be at a commercially covered age. So the disease does start sooner so remember, historically, we were in combo cataract. So from a combination cataract, that tends to set off and be a procedures done at the Medicare age. But for glaucoma or high pressure, the open starts much earlier. And so I do think that over the course of the next 5 and 10 years, you'll see a higher percentage of our book of business be, especially on the commercial side than we've historically experienced.

Thank you for that. Outside of reimbursement, is there -- are there other content that we need to be aware of? You need particular size room, in a particular space, staff, anything else that might constrain uptake?

Not the things that you just mentioned. I think -- any time that you're -- so one of the elements of the larger opportunity, I'm not so sure it's relevant in the context of the near term and the numbers that are out there are these expectations. But when you think about the broader opportunity of 20-plus million eyes that have high-pressure glaucoma, 14 million eyes that are diagnosed at any given time, 10 million eyes that are diagnosed and treated at a given time. That's an awful lot of patients. So they're -- put that in context, there are 4 million cataract surgeries done a year. So over the next decade, the shift of that and how practices handle that, both in their office, in an ASC setting in an HOPD setting, et cetera is an important to unlocking the much bigger opportunity to associate with it. Again, I'm not so sure that's as relevant in the context of near-term models that folks have here. There's not a lot of volume attached to those numbers. But when you start getting out and you're trying to really go after changing the standard of care, whether it be iDose and Infinite or SLT or other things, there are shifts there that have to happen. And the good news is I think the industry has done a great job historically of adapting to make that a reality. I think we'll do it again.

So one of the things that we talked about early on the -- with the clinical trial and with the labeling, et cetera, can this be done in a physician office? And what does it take to move this out of an ASA or into a doctor's office?

Yes. So the first part of your question is, as a technical matter, absolutely. It can be done in office. We had multiple sites in our iDose study that did all of their patients or virtually all of their patients in an in-office setting. We have that data, both from a safety and efficacy perspective. And we plan on -- I think Tom has been pretty consistent for as long as I can remember that our goal is to be site-agnostic. That iDose can be delivered in the office. It can be delivered in the ASCs, it can be delivered in the hospital and that we've enabled that both from a technology data and reimbursement perspective. The technology element of it, it can be done. The data element, it's there for most of these folks who do that -- they will have an investment component depending what they've got set up. Some of them already have in office setups, it's plug and play. For others, they have to create a sterile field, which can be a minimal investment or as significant as they want to be, a clean room, if you will, with laminar hoods type systems that create that sterile field environment, that's not a huge impediment to making that happen. I think the biggest thing is just establishing the reimbursement side of that. So as you establish professional fees and facility fees, you cross-walk those to in-office codes. And that's something that we've said publicly we intend to try to have as we exit 2025 and going in 2026 to really start to enable those customers who want to do it in office. That's our goal.

So it's 2025, 2026?

Well, you want to really -- the application and the adjudication process of getting those codes established is something we want to tackle over the course of 2025, so that as you go into 2026 -- it's another area where we can start to focus with those customers who would prefer to do the procedure in office.

So the next-generation iDose, I believe is the one that may be able to be removed and redone or okay. Let me ask a question in a different way. Talk to me about the next generation iDose and what does it take for a redo procedure?

Yes. So as you know, our data and our procedures ISTR itself is been proven safe and effective, and we believe as well in the context of doing multiple procedures. That's an ongoing conversation with the FDA, as we've talked about in the past. As it relates to iDose TREX, which is the extended release version of that, we've committed -- we're going into clinical trials here by the end of the year. And we'll work through that study over the next couple of years and hope to have that as another solution on the market for physicians in the '27, '28 time frame. So that that's another option in this overall arsenal for folks to be able to do this. I think, again, back to the earlier part of our conversation, the way we see it, I think the way many customers see it is, there's a lot of options. Our goal is to have where they could do iDose TR, TREX entire time. But they do have a lot of options as a part of treating these patients, both ours as well as others. And I think that, that will evolve as we move forward here. But I think we're pretty confident that whether it's TREX or TR, it's safe and effective for repeat utilization, and we just need to make sure that the FDA agrees.

And that's a label change?

On an existing TR, it would be.

Okay. But on TREX?

TREX will, that's a study to be done. So that's a part of the -- the study, the study design and ultimately, the label negotiations that happen as a part of that.

So if you start by the end of the year, walk me through the time frame, is that 2 years forward, 3 years?

Well, I said TREX itself would be -- and we've said publicly '27, '28 timeline for trying to get that on the market.

Okay. We had a doctor -- the doctor that was here yesterday was talking about how we thought 30% to 40% of his procedures of his patients would be iDose eligible. Does that sound low or higher? That's just about right?

Well, I think it's early days. And so I'm not sure folks have had the opportunity to really think that all the way through. I would take a step back and say, it's definitely low. And the reason for that is that the label of iDose and where it's been studied is wide open. If you think about it -- we had a very large pivotal study that covered patients up and down the disease spectrum from just pure ocular hypertension on zero meds to multiple meds and more advanced disease. And so we've got large cohorts of data across each one of these things, and as is often the case, think where that answer might be coming from is less of a clinical answer and more of a market access question. So often, you have to take both in consideration Clinically speaking, iDose TR is appropriate for pretty much any patient who has elevated pressure and/or diagnosis of glaucoma. And you can see that in the label, like any other topical prostaglandin, or topical glaucoma medication. But what happens at the beginning is it may only be eligible for 30% or 40% because it's Medicare fee-for-service. And you're waiting to turn on commercial coverage, you wait turn on Medicare Advantage, et cetera, et cetera, to open that patient population up. And each doctor will think about their algorithm a little bit differently. So for some, they may prefer to do x first and then as that wears off, they go to iDose. Others are going to say, well, I already know that the prostates work wonderfully when the patients take them. I want to get the [indiscernible] the eye as fast as I can, in which case, they're probably going to do iDose or DURYSTA or whatever it might be as a part of their first-line care. So everyone that will be an evolution over time. And you'll get different answers from different doctors most certainly as we move forward here.

Which makes sense. Alex, will we have you. Can we talk about profitability and the margin opportunity with iDose?

Of course. Thank you. So let's start with the margins, right? And -- as you think about the margins today, we're sitting in this 80% to 83% ZIP code, and I'm sure you're referring to can those margins expand over time, especially with iDose. And the short answer and the good news is, yes, iDose has a very attractive margin associated with it. And we fully expect as the scale of iDose increases over time and it becomes a larger share of our mix of product revenues that we should see accretion in the gross margin. And -- and we have a vision and a line towards that. And hopefully, we'll see some of that happen next year. And then turning to the question of profitability. It's a natural question to ask as well. We are -- first off, we're excited about what the financial opportunity of what iDose means for the company. And the same thing I'd say is we, as a company are highly ambitious and a lot of those ambitions can be seen and felt in our rich pipeline. And so in the near, we've gone on record saying our near-term goal is going to be to get back to cash flow breakeven live within our means and fund that rich pipeline that will hopefully produce an offspring a lot of great products in the future that will continue the growth of the company over time. So that will be our goal in the near term. Now that being said, with the success of iDose and there certainly could be and will be, and we anticipate seeing quarters of profitability along the way. But again the near-term goal will be continue to fund that pipeline and continue to live within our means based on the revenues and the cash we generate from my iDose.

So different company management teams have a different plots about profitability. -- somewhere like valued on an EV to revenue multiple. I'm going to push that revenue as hard as I can. Others, to your point, live within your means, how think about balancing those two? And what is the time frame for that balance? Because when I start running numbers and start putting high gross margins on iDose you have a lot of cash, that's about to flow out.

Right. So I think you have to think about it in what is in that pipeline and what the cadence is. So again, near term, let's get to the cash flow breakeven, let's start to fund these programs. and see what happens. But you also have out there, and we haven't talked about it yet is we have a retina program, and that retina program could be very expensive and could cost a lot of money. And so we'd have to prepare for that and get that. So I think in the near term, to your point, we're going to focus on growing the top line and really focus on the revenue growth and show that to investors as part of the big story.

And I was going to add, I think I get your -- where you're coming from on that, in I can tell you philosophically, we don't really think about it from a Wall Street perspective. We think about it in terms of opportunities that we have in front of us that can meaningfully grow the business and ultimately change the paradigm. And to Alex's point, we're pretty fortunate that we've invested so heavily in terms of the -- our pipeline, our ability to sort of drive future product flow. And I think we want to avoid being in a position where you have to make unnatural decisions because of any quarter's EPS or whatever it might be, we'd prefer to prioritize what we think is in front of us in driving that future growth opportunity. And so what you're hearing from Alex is a commitment to try to get to a place where we live within our means. But not a commitment yet that we're ready to say we're going to be this incrementally profit generating quarter in and quarter out. And I think we'll be transparent when we get to that stage -- that that's the stage we're in. But right now, we're still very much in maximize the top line growth and maximize organic investment in the business and do it in a way that is within our capabilities and means as a company.

So, so far, when you've commented on the quarter, you've been helpful in giving us commentary such as iDose doubled in the third quarter versus the second quarter. So whatever my assumption is for this quarter assuming it's right, it's doubled. When you talk about 2025 guidance, are you give us sort of breadcrumbs to piece together how much iDose is in there?

Yes. I mean I won't get too specific as to we're in the process of formulating our game plan on that front real time. But I will say, if you take a step back in the context of 2025, given our scale of company today and the scale of opportunity and the expectations of iDose, irrespective of what we give, there's really no hiding it. The reality is that the significant chunk of the growth that's coming is coming exactly from that area. I anticipate at a high level, us taking a similar approach to what we've done, which is continue to give that top line view of what we've got and then giving -- using your term enough breadcrumbs that you can piece together the individual drivers of those, the puts and takes. iDose being the single most important of those. And again, I'll just repeat. I don't think when push comes to shove in 2025, you're going to grow the iDose number because it's such a significant portion of where the growth is coming from.

I'll be able to get there?

I think you'll get pretty close.

Okay. The pipeline, what should we think about what's next? And what should we think about for the mudstones to track that?

Yes. Well, we've talked about a little of it. I'll go not necessarily any particular order, but if you think about within the glaucoma franchise, us starting the trial around TREX the continued progression in terms of clinical enrollment there over the course of 2025, ultimately completing that trial and moving on to the next phase that is a component of that franchise and what we want to see. We also want to start to see some of these products get their approvals and clearances internationally. So in particular, I think I'd focus on an infinite and getting that going in Europe and some of the other markets, we've started to put our toe in that water in places like Australia and Canada and Latin America. I'd like to see that arrive in Europe and certainly in Japan. And so there's multiple growth drivers from that standpoint. I think the next thing that people will start to pay attention to is Epioxa in the context of our Corneal Health business and rightfully so, especially as we've said, we're going to file the NDA by the end of this year, and I suspect that investors will start to spend a little bit more time thinking about what that means for our business. And the profile of that product over the course of 2025 really is set up to, hopefully, end of the year approval and commercialization in 2026. And I think it's pretty meaningful for us. If you think about what it means for patients in terms of not having to remove that or layer of the cornea as part of the procedure, the pain and all the various elements there, the procedure time in the context of the efficiency for the office. And our ability to sort of reset from a market standpoint and really launch this as a proper specialty drug. Relative to the way maybe it was done historically as a small private company. I think there's a lot of opportunity there for us. Beyond that, you know our other platforms we've talked about. We have the dilution platform and all the shots on goal there to try to change the way the topical drop industry has worked and we're hard at work in multiple fronts on that. And then as Alex referenced on the retina side. I think we're starting to see a little bit of attention from that and rightfully so. But that's a pretty meaningful shot on goal that we have, where we've talked publicly about pretty translatable animal data that is profound in terms of multiple years' worth of efficacy from a single injection, in the world we're living in now that would be transformational. But it is terribly exciting, terribly early as we like to say. And we'll just have to see we're in clinical trials or early safety trials on that. And -- so looking for that data. And obviously, the progression in the more proper Phase II and ultimately Phase III studies is next on that front.

And international, what are the obstacles of setting it up and getting that business going?

Well, you mean in the context of additional products that are entering out there?

The geography -- use additional products. I mean, at this stage, international if memory serves is less than 10% of total revenue. How do you get that to be maybe a more significant contributor?

It's a little bit more. So I would tell you, actually today, our national business is running towards $100 million of revenue for us. And this was a big push for us in kind of 2017, '18, '19 time frame and establishing, which is not easy, by the way, right, as a small company, establishing international. We're in the majority of the major geographies now, all the major European Brazil, Canada, Australia, Japan, with direct operations that we continue to grow and expand both commercial and market access and the like. We're where we need to be there. We've just recently announced that we're entering into China. We got our first approval there. And so that's a beast of in itself in terms of growing that business and commercializing there. So I would tell you that of the major target markets, it's less about entry and it's more about continuing to scale. And anytime you're especially outside the U.S., where you're dealing with centralized payer systems, you have to play the long game there oftentimes from a market access standpoint. And we've been making those investments for some time now and continue to sort of try to grow and mean access for our products and technologies and markets. But it's been a terrific business for us for many years now, and I think that will continue to be the case for many years to come.

So what does it take to bring new products into those markets?

Well, that's changed a lot. So historically, folks would bring new products into Europe first and then it would ultimately get approved by the U.S. But in some respect, that's actually flipped. So ironically, you can get a product in the market in the U.S., which is not the fast place in the world, you can get it there before you can get it in Europe with the changes around MDR and the like. So -- and then one of the challenges I think we all have with the new European regulations is a lack of -- it's pretty opaque. So with the FDA, there is an interlocutor, you're having conversations, there's time lines. There's different thing that you're. In the Europe market now it's become a bit more of a year in the queue and get to you when we get to you. And so it's harder to answer with specificity, you provide the dossier of the information, the application all the kind of thing and you wait to be kind of your turn up in the queue. And then ultimately, we'll get there, some of these new products but and we've been in the queue for some time. I'm hopeful it will come soon. But it's hard to give you a specific time line on that.

But it doesn't sound like it's identifying new markets check entry engineer markets, double check. Just a matter of getting things through the queue through the regulatory process, with a feet on the street?

Getting them through the process and then ultimately making sure you've got the proper payment reimbursement coverage within the central payer systems, is the other thing that you have to do again, not something that we're new at. We've been in these markets now long enough, we've got that. But yes, the biggest thing there is as you continue to build upon, as you continue to invest in your sales force, your marketing apparatus, your market access -- really your infrastructure in these regions. -- and building what I'll call per businesses in these geographies and we're still on that journey.

When we're talking this time next year, my fair question, what do you think we're going to be talking about?

Well, I'm sure we'll see if you have the same restraint, if you can wait for 15 minutes to talk about iDose. But to be a similar theme, but I suspect that hopefully, at that point, folks are confident with the trajectory that we're on with iDose. That enables really a more meaningful conversation around how to segment the opportunity associated with it in the next 2 and 5 years beyond, can it be successful? And at that point, you start getting pretty excited about that broader opportunity to exist with iDose over the next 5 and 10 years. And I think alongside of that, it enables us shift the conversation to things like Epioxa the things like the Retina Program and the broader franchises that we've been building quietly for some time, [ A-Glaukos ] behind the scenes where people can really start to see what we see in terms of the opportunity in the next 5 and 10 years. I think it will be exciting.

Joe and Alex, thank you so much for joining us today, and I hope you have a great day in Miami.

Thank you. Joanne.

Thank you.