All right, great. Good afternoon, everyone. Tom Stephan with Stifel. Very pleased to have Glaukos here with us today. Happy to be joined by Joe Gilliam, President and COO, Alex Thurman, CFO, and Chris Lewis, VP of IR and Corporate Affairs. A lot to get to. I'm going to dive right in. Start with everyone's favorite topic, iDose reimbursement. Maybe to level set, Joe, can you update us on where each MAC stands with iDose reimbursement today? Any changes to call out since the late April earnings call?
Sure, Tom. Thanks for having us. Yeah, nothing I would say is a significant adjustment of any material nature since the, you know, Q4, Q1 earnings call. The year starts to get ahead of us in late April. The status as we sit here today, similar. Obviously, we continue to make progress, but, you know, with Meridian, Novitas, and First Coast, you know, really where you expect them to be in the context of the drug, the facility, and the professional fee. That is followed by WPS, as well as Palmetto, who are now increasingly paying the drug and the facility as they should. We are still very focused on the professional fee adjudication there. Payments are happening, but they are not happening in the automated, you know, systemic way that ultimately you get to with the Medicare administrators. CGS is showing signs of that, as is NGS.
I think NGS remains the slowest to get there, but they are paying the drug and the facility as well as the professional fee on an increasing basis. There is still a lot more work associated with that than ultimately when it becomes, you know, more of a systemic or systematized solution.
Got it. That is helpful. Appreciate that, Joe. What kind of guides the timing of progress? Is it a numbers game? Is there visibility or, you know, what should we be looking out for? Is it really just somewhat unpredictable?
No, I mean, there's not a, there is no statutory even volume threshold, but really it does come down to generating volumes. And clearly in the early days when you have a procedural pharmaceutical like this, driving those volumes when there's that sort of inherent risk, if you will, to reimbursement is the first order challenge. As you start to get that through and you start to see the J-code get adjudicated as it should, that lowers that bar a little bit and you can continue to get a little bit more, you know, trying and trialing in each of these MACs as that's happening. And that extra volume is what ultimately helps them get the information they need. Remember, these Medicare administrators, it's all about collecting information. It's an imperfect system.
You know, obviously we tell them this information, but part of their mandate is to go out and make sure that they're seeing from the actual care practitioners that it's being used as it should be and on label and all those type of things and how much time is associated with the procedure. That process of gathering data really is one of volume. We continue to sort of make the case in and around that directly to the MACs through both our efforts as well as various advocate societies and the like. That process just continues to unfold, you know, one day at a time, one procedure at a time, and we're making progress.
Got it. That makes sense. That's helpful. You know, I hear from investors, I guess, a fair bit about concerns around iDose's price potentially being elevated, being too high, and that maybe there's payer risk. We know DURYSTA has essentially fully comprehensive coverage across all payers, although their ASP there is around $2,000. I guess to what extent is iD ose's ASP an actual risk towards not ultimately receiving coverage? Or is iDose's reimbursement kind of more of a when and not an if? If you can touch on that, that'd be great.
Yeah, first of all, I don't think that is the primary determinant here in the grand scheme of healthcare and procedural pharmaceuticals, or even using, as you referenced, DURYSTA. I mean, obviously iDose has seven times the amount of drugs. So when you think about that $2,000 ASP and on a drug load basis, it's actually equivalent. And when you look at the sort of, you know, efficacy in the real world, it's certainly from a clinical perspective, they tend to be somewhat at parity. The fact that our drug lasts so much longer, designed that way, is obviously a difference maker in the context of how you think about both the ASP as well as, you know, the product clinically. When it comes to the actual coverage, that's not a consideration, certainly in the case of the Medicare fee-for-service world.
As you get into the commercial carriers, both for their commercial plans as well as Medicare Advantage, they're obviously, it's one of the many factors that they look at. But what I can tell you is that, and we've said this publicly, we already have the same coverage virtually as DURYSTA with iDose, both on the commercial side as well as with Medicare Advantage. That's, you know, roughly 50% of those lives being covered in an actual plan. And where we've got that coverage, it looks very much like the DURYSTA policy. In fact, most of these providers or these insurers have just simply updated their existing policy that said they have one and put iDose into that with the same or, you know, very minor differences in terms of the access to iDose versus a DURYSTA. For the other 50%, you know, that's not uncommon.
They don't, it's not a covered procedure, in which case it's silent. We're continuing to see, even in these early days, you know, like a United that doesn't have a specific plan, we're seeing it go through successfully with prior authorizations and gaining access to technology when it's appropriate for the patient. Last thing I'll say is, whether it's DURYSTA or iDose or really any interventional approach, today most carriers take an approach of trying to put it into second and sometimes third line therapy, you know, behind either a failed drop or failed a couple of drops or a drop in a procedure. That's what you'd expect when you're in the beginning of launching something. We'll continue to cultivate the data, et cetera, to try to drive that closer and closer to first line over the course of many years.
Got it. That's great. Sticking with iDose, I'll ask a couple more near-term questions, but Joe or Alex, to kick things off, can you talk about just the 1Q 2025 iDose performance? You know, more specifically, I think it'd be helpful if you could maybe frame it in the context of where we started, which is where the different payers stood in terms of J-code and reimbursement progress, and how maybe a sort of lag effect on reimbursement milestones may have played a role.
Yeah, I mean, obviously from our standpoint, it was another quarter of exceptional progress and another big step in the right direction. You know, as you try to get a bit more granular on that, Tom, around the various payers, what I'll say is from a Medicare standpoint, you really entered the quarter with Meridian, fully operational, we'll use that term. The J-code and facility were increasingly getting paid as they should in Novitas and First Coast. That really was something that kind of took place over the course of the fourth quarter and coming into the first. You remember that towards the end of January, First Coast and Novitas came out with their professional fee schedules, which effectively really started working as they should about a month later, kind of going into that March timeframe.
I think the, and obviously there was varying degrees of progress throughout all the MACs. I think the heart of the question, I mean, obviously there's a degree of seasonality. That's a little less critical when you're thinking about it in the context of a new product launch like iDose, but it is a factor. I think the bigger thing is that these milestones, as they unpack, if tomorrow we announced or there was another professional fee schedule, for example, to come out, the real impact of that might not be felt for three or six months. That's simply a reality of when an event happens, translating that into proper education of your salesforce, ultimately your customers, operationalizing that, and then taking into consideration their own schedules, right? I mean, you do a great job of covering ophthalmology, Tom.
You have an understanding of the backlog dynamics that exist in terms of when these doctors schedule new procedures. It can be as fast as one to two months, but for some, it's three, four, five, six months out that they're scheduling. That's something that you have to take into consideration whenever you're looking at the, I'll call it the translation of that milestone into the order. Remember, with iDose, it's a just-in-time ordering process. It's not like when they schedule it, they order that iDose. They wait until the week before, sometimes even days before to order the iDose, which we overnight.
Got it. Okay. That's super helpful and makes sense. You know, I guess in that context, you know, what does this mean for 2Q 2025 iDose, having entered the quarter with, I'd say, three critical MACs, Meridian, Novitas, and First Coast, having fairly comprehensive fee-for-service reimbursement between the J-code, the facility fee, and the physician fee? Importantly, you know, you have stated, you have that, I'd say, as a net tailwind. You have seasonality as a net tailwind in 2Q, but us in street are only at $25 million roughly in 2Q iDose sales. That's up only, I think, $4 million-$5 million roughly from 1Q, and it's below the 3Q to 4Q step up of $7 million-$8 million.
Long-winded way of asking, you know, why would not we see a larger acceleration in the sequential dollar growth in 2Q iDose than only what street is modeling at the $4 million-$5 million?
First of all, I think that's awfully precise, Tom. You know, not only do we not guide on a quarterly basis, we certainly do not guide individual products on a quarterly basis. I would just take a step back and, at the risk of taking too much time, I would reiterate a lot of what I just said, that the reality is that every, you know, week, every month, every quarter is incremental progress in terms of unlocking what is the key moment here around reimbursement. The translation of that can be, you know, also weeks, months, and even in some cases, quarters around the facility uptake, if you will, as those surgeons schedule. I think at this point of the launch, you know, what you're starting to see is continued progress within Meridian.
At this point, that's a pretty well-accepted fact around obviously the coverage, pretty well-known. Our salesforce is busy trying to drive operational behavior as well, yeah, and expanding access in new surgeons and new surgical sites and getting their sea legs there. With Novitas and First Coast, you can imagine, you know, we've been in that process now for a little while of making sure everybody knows that indeed everything is operating as it should be and the professional fee is operating as it should be. You expect to see incremental progress out of that area. On those other MACs, you see fits and starts, right? Any given month or quarter, the salesforce continues to run through those brick walls, so to speak, ahead of getting that streamlined.
Sometimes that comes with, you know, more positive months and quarters, and sometimes there's a little bit of a pullback in that. Certainly dynamics that we saw throughout 2024 and in the first quarter of this year, and I'd expect a little bit of that, hopefully a waning amount of it as we move forward, you know, throughout this year.
Got it. That's great. Sticking with iDose, but maybe thinking a bit more intermediate to long term, for the 2025 iDose, I'll call it the guide, I think that's around $120 million-$125 million. Street has $45 million for 1 H, $75 million-$80 million in 2 H. Can you just talk to kind of assumptions within that back half step up and maybe just your level of confidence today in achieving that full year guide?
Yeah, I think again, we never have gotten that granular around the sequential steps of that, that the street doing their best work, which we certainly appreciate and respect. We've obviously always expected to have a little bit heavier back half of the year, in particular the fourth quarter, given seasonality, but also the dynamics we've been talking about, you know, repeatedly here. I think every quarter goes by, you have a bit of a building of a backlog in terms of those procedures and those doctors that you're continuing to sort of turn into or onto iDose and get them going. Many of them might be today scheduling procedures actually a lot for the third quarter, if not even the fourth in some cases. You continue to expect that build going into it.
As you know, we have been, you know, sort of methodically, I'll say very methodically turning on access to commercially covered lives as well as Medicare Advantage, which to a lesser extent will be impactful in the second half.
Got it. That's great. As we kind of look at the more intermediate term for iDose, I wanted to ask about sort of how we should be thinking about the launch, I guess thematically. iDose is in large part a drug, but obviously there's a device component, there's a surgery component. Should we kind of be viewing the launch and ramp as more procedure related since it is surgery and not just scripting out drugs or doing a quick injection? We have to layer on the complexities of drug reimbursement to that. Maybe just thematically, you know, how should we be thinking about the launch?
I think we've always been consistent on this. The reality is, you said it right, that there is a drug component in the fact that there's a J-code and the way that that all works mechanically. From an adoption and driving that from a salesforce perspective, from a launch curve perspective, if you will, it's very much a procedure. That's because, to your point, if you think about a traditional drug launch, there's a degree of clinical education, and then it's about script writing and fulfillment, obviously through the pharmacy chain. There's a lot of complexity of that too, but it's mostly in terms of that fulfillment channel.
Here you have that process of both educating the physician on the procedure, the clinical, the actual OR, which is the most straightforward, obviously, of any product we've launched, and I'm sure you picked that up in your channel checks as well. You know, the thing that gaits this launch more than probably anyone we've done in the past is it's not about teaching these doctors how to do angle-based procedures or the why behind, you know, doing that. It's about that broader interventional glaucoma messaging, which we're having a lot of success at, but it's also about that back office education.
Making these oftentimes small businesses operate successfully from a billing cycle and reimbursement perspective, and then totality around that, that education, that handholding, that support is really what is going to set this apart over time. The more proficient that these offices can get, the more that the physicians and the broader business around it are going to feel confident around doing what they want to do clinically. We'll get there, but that dynamic will continue to play out much more like a procedural ramp or surgical ramp than a pharmaceutical in that context.
Got it. That's great. A couple more on iDose and then I want to pivot. You know, as we think about the iDose launch today, and I hate to focus too much on the near term here, but, you know, investors maybe were hoping for some bigger numbers up until this point, but obviously it's very, very early. The question I get from investors is whether there are any unexpected dynamics to date beyond reimbursement that could, relative to expectations from the street, be suppressing the launch. Are there any fundamental factors that so far could be more challenging than anticipated, or does the pace of the launch really just come down to basically not much more than the timing of reimbursement progress? Maybe if you can touch on that.
Yeah, it's a good question. I think in some ways it's answered by the enthusiasm that investors have and the reason behind that, right? I think one of the things that, you know, we in looking back, you know, recognize is that especially over the latter part of 2024 and entering into the very early days of 2025, there was a lot of survey work done. There was a lot of diligence done by a lot of investors. We appreciate those efforts, that work, that attention, that focus. What it highlighted was that the product was performing as advertised and the clinical enthusiasm of our customers was extremely high. You know, when you think about the building blocks, the layers of any launch, that's what you hope to start for, right?
As we say to our team, the great news here is that we continue to have a product that's delivering commercially what it did clinically in terms of the study and the controlled environment. Now it's out there and the results are terrific and the physician appetite is terrific. That I think led to a little bit of unbridled enthusiasm, which again, I totally, we totally respect and understand. It just didn't have the overlay of the key dynamic, which is it doesn't matter how much a doctor loves a product. The broader apparatus has to believe that it's going to get paid, that they have confidence around it, that they can sometimes even when they've got that, that they can operationalize that successfully to make sure that patient selection is happening the right way, et cetera, et cetera, et cetera.
From our standpoint, it really is those related dynamics around that market access component and then expanding that and operationalizing that into success at the office level to really enable those doctors to do what they want to do clinically is the key item. When we get past that, Tom, there will be a point in time in this launch where, thank goodness, probably for my market access colleagues inside of Glaukos, we're talking about this a lot less, right? We're talking more about the next level of investments we're making to drive that broader interventional glaucoma shift, which is, you know, we've been doing a ton of behind and underneath the scenes to continue to move that narrative and move that change in behavior. That's all set up for that longer term, much larger opportunity around doing what's right for these patients interventionally.
We're going to get there where it's more focused on changing behavior that way than worrying so much about the various no's you can get inside of an office.
Got it. Okay, great. Just a couple more on iDose and sort of more intermediate term here again, but as we think about, let's call it the next one to two years of the iDose ramp, is it prudent to think about that launch in the intermediate term as maybe something more gradual or linear, something more deliberate, methodical, as opposed to looking for a launch that's exponential, that's parabolic? Maybe if you can talk to just kind of your thinking around the next one to two years of that ramp.
Yeah, it's a little bit hard to predict in the context of the statistics of ramp curves. Obviously, we continue to look for an accelerating rate, if you will, in terms of the launch curve, if you will, from a performance standpoint. So far, it's been relatively linear, I think just because of the way that the MACs have kind of come online, you know, over that. Once we've kind of got that and the full salesforce is operating the way we can, I would hope to see a little bit of acceleration there from a linear to a little bit more pronounced growth curve. I also, I'm not saying that you all should necessarily count on that.
I think the realities of, you know, getting through the fee-for-service side and then getting confidence one account at a time around commercial plans and executing that alongside of that, changing their behavior both in combo cataract setting as well as obviously on that broader standalone setting is very much still a hand-to-hand combat education game. I think for as long as I can remember, I was talking about iDose, we've talked about this as a 10-year cycle, just like we went through different dynamics around it, but still a 10-year cycle that I think ultimately is very rewarding to investors over a prolonged period of time, but does take, you know, it's not going to happen in any one quarter or even any one year in terms of the gloves coming off.
Got it. That makes sense. You mentioned kind of the 10-year cycle. I think that's a good segue into my last couple of questions on iDose. Just on peak sales, Joe, maybe to start, in what framework does Glaukos think about or even model out your peak sales estimate for the iDose platform? Maybe that includes TREX as well. Long term is iStent volume an analog? Is it anti-VEGF, some mixture? You know, how does the company frame the peak sales opportunity for iDose as you model out your numbers?
Yeah, I mean, I think to be fair, we look at all of those things where the stent side of things is more about how quickly within ophthalmology a successful surgical procedure, quote unquote, can scale. Clearly, that was within a much smaller market opportunity. We do look at that. We do look at the way the dynamics shifted, for example, in the retina spaces you referenced, that it took a little while to take a universe of physicians who had largely done surgical procedures and not really done the type of approach that was inherent with anti-VEGF to when they started to adopt and what that then looked like over that subsequent, you know, five and 10-year period.
We do look at all those things, but can we also look at the bottoms up side of this, which is we know where the lower hanging fruit is, the post-DURYSTA utilization, the post, you know, SLT utilization, combo cataract, all of those type of things is forming the basis of, I'll call it the relatively near to medium term. And then what do you have to believe within that broader opportunity of 22 million eyes for the next, you know, phase of that, if you will, over the course of the five and 10-year period, what kind of penetrations are there? The good news is for us, we have a product that works in a market that's quite large. And you're going to see continued investment from us in unlocking that both in traditional means as well as non-traditional.
Got it. Last one on iDose, and then I'll squeeze in a question on the U.S. stent business, but I guess since late 2023, since FDA approval, has the company's peak sales expectations for iDose changed, whether higher or lower? Maybe you can talk to how 2024 tracked relative to your expectations as well in the context of your peak sales view.
Yeah, I don't think from a straightforward perspective, the peak sales have not changed. I think they've actually, in the context of our models, they've gone up a bit on a risk-adjusted basis. To be fair, when we do these things, we look at risk adjustment based upon where in the product is at in its life cycle. Back to your earlier comments, once you're out in the real world and you see the product performance as it should be in the real world, your confidence rate around those, you know, peak sales estimates go up. In terms of how we would model it, for example, our board or otherwise, those numbers on a risk-adjusted basis have gone up.
Got it. That's great. A couple more to finish on U.S. stents. U.S. stent business in Q4 2024 was up mid-single digits and in Q1 2025 down mid-single digits, I think LCD driven. And then you brought down guidance for 2025 on that subsegment to down mid-single as well. Just to kick things off on U.S. stents, Joe or Alex, maybe if you can talk to how doctors are adapting to the LCDs of late, are you seeing the headwinds from that becoming more pronounced, less pronounced as we've moved through 2025?
Yeah, I would not break it short. I probably go back to what we said. You know, obviously, as we made our way through the first quarter and awareness was there around the LCDs, the impact, I mean, sometimes it takes doctors getting something kicked back, right, from a MAC around that to start changing that behavior. You started to see that. We have attempted to reflect that, obviously, in the guidance that we have given for the year. We will see how it plays out. We have puts and takes around that. I think one thing that was encouraging to us, obviously, was in looking at the results from others in the first quarter, our iStent business did quite well. It is hard to say that when you are down mid-single digits, but obviously there was an awful lot of procedures taken out of the marketplace as a part of that LCD.
I think we've held on to that, you know, quite well through that process. Did we just lose? Can you hear us? I'm sorry, we lost our screen for a second.
Yeah, I can hear you guys. You're good.
I think we felt pretty good about that on a relative basis. I think that's a factor of obviously our standalone opportunity with iStent Infinite, driving a little bit of that on a relative basis, as well as obviously the broader halo effect of iDose and the role we have in the physician's office right now.
Got it. Got it. Then last one here on U.S. stents, the Hydrus royalty headwind did commence, I believe, in April. Your rest of year stent guidance, excluding the Hydrus royalty, by our estimate is down only low single digits versus mid-single digits in Q1. It seems there is confidence that Q1 on a normalized basis is likely the trough. Is that a fair way to think about it? Maybe you can talk to the guide in the context of the Hydrus royalty.
Yeah, I would not get that granular. There are a lot of scenarios that we run under every single one of these situations. You are accurate that the Hydrus royalty comes to a conclusion going into the second quarter. From that standpoint, that is right. Everything else, we have run a bunch of different scenarios. Clearly, you know, our expectation would be as we make our way through the year that some of the, I will call it, LCD impact gets sunset. You may not all see it in the form of stents. In some cases, it might be the iDose that is actually, you know, benefiting from that as well. That is why I say there are so many different scenarios that we are analyzing and some of which is the mix within our own business and what that means.
Really as we move forward here, our overall objective is to continue to meet and exceed expectations for the overall glaucoma franchise and certainly the overall company.
That's great. I'll squeeze in one more. Alex, I'll pull you in just on profitability. Extremely impressive incremental margins in our view have gone unnoticed by investors over the last three, four quarters. Alex, is free cash flow break even still the target or the goal in the near term? Maybe if you can quickly touch on that in the last minute or so.
Sure, I'll be quick. Absolutely, that is our near-term goal, Tom. We continue to monitor and make episodic investments as needed and as they arise. Definitely that is our goal to get to cash flow break even and live within our means as we've talked about a lot over the last year or so.
All right, fantastic. Alex, Joe, Chris, thank you guys as always. Really appreciate it.
Thanks, Tom. Thanks for having me.
All right, take care, guys.