Glaukos Corporation

in a listen-only mode. Later, we will conduct a question-and-answer session. To ask a question, please press star 1 on your telephone keypad. To note, this call is being recorded. An archived replay will be available online in the Investor Relations section at www.gloucose.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Thank you, and good afternoon. Joining me today are Glockos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call. As such, for this call, we will make brief prepared remarks and transition into a question and answer session. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may by forward linking statements. Review today's press release and our recent SEC filing for more information about these risk factors. You'll find these documents in the investor relations section of our website at www.globcos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Globcos' ongoing results of operations. particularly when comparing underlying results from period to period. Please report in the tables at our earnings press release available on the investor relations section of our website for reconciliation of these measures for the most directly comparable GAAP financial measure. With that, I will turn the call over to Glockos Chairman and CEO, Tom Burns.

All right. Thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glockos reported record second quarter consolidated net sales of $95.7 million. up 19% on a reported basis and 20% on a constant currency basis versus the year-ago quarter. As a result of our strong performance, we are raising our full-year 2024 net sales guidance range to $370 to $376 million versus $357 to $365 million previously. Our second quarter record results were broad-based, with growth being driven by both our U.S. international glaucoma franchises where we continue to accelerate efforts to expand access to interventional glaucoma tools for the benefit of physicians and patients. Our goal to advance and improve glaucoma care by driving earlier intervention continues to build momentum as we lead and work closely with surgeons and thought leaders globally to organically drive this broader evolution in the standard of care. Within our US glaucoma franchise, we delivered record second quarter sales of $49.8 million on strong year-over-year growth of 26%, driven once again by strong growth within our overall iStent portfolio, led by iStent Infinite, along with early but growing contributions from IDOS-TR. Utilization of iStent Infinite for glaucoma patients that have failed medical and surgical therapy continues to expand as our ongoing clinical education efforts and improving market access landscape takes hold. Importantly, During the second quarter, five of the seven MACs issued draft MIGS LCDs that established coverage for Iceland Infinite that is consistent with our original reconsideration request. We have actively supported industry efforts to encourage areas of improvement in these draft LCDs and look forward to their finalization as we expect it will be an important step in unlocking the remaining Medicare Advantage and commercial plan coverage for Iceland Infinite. Turning to IDOS-TR. I'm pleased to report that we successfully advanced execution of our detailed launch plans for this first-of-its-kind intracameral procedural pharmaceutical that was designed to deliver glaucoma drug therapy for up to three years. Outcomes and feedbacks from early cases continue to be very positive and reaffirms our view that with the launch of IDOS-TR, we are pioneering a brand-new therapeutic category that has the potential to reshape glaucoma management as we know it today. During the quarter, we successfully expanded access of IDOS-TR to all of our sales field personnel while continuing to target those surgeons' facilities comfortable utilizing a miscellaneous drug code. In addition to our commercial efforts, the launch has been supported by a growing set of clinical literature now consisting of seven different peer-reviewed publications highlighting IDOS-TR as a transformative new treatment alternative for patients suffering with glaucoma and ocular hypertension. As you know, a key element to the stage gating of our iDoseTR commercial launch is market access. As scheduled, the unique permanent J code for iDoseTR, J7355, became effective earlier this month on July 1st, 2024. This now effective J code is expected to increase patient access and will allow us to expand training plans to future waves of surges in facilities. We're also advancing efforts to secure professional fee coverage and payment with VACs, as well as establish commercial and Medicare Advantage coverage now that the permanent J code is effective. As noted in the past, we expect increasing adoption as reimbursement confidence is gained by our customers over the remainder of 2024, and more specifically in the fourth quarter heading into 2025. Earlier this month, CMS issued their proposed 2025 facility fee and professional fee rules that, as drafted, largely maintain the 2024 reimbursement assignments and rates associated with our procedures. Finally, as promised, we have now engaged the FDA in a formal regulatory dialogue regarding the re-administration of IDOS-TR, and beyond that, remain on track to commence a Phase III clinical trial for IDOS-T-REx. our next-generation eye-dose therapy by the end of 2024. Moving on, our international glaucoma franchise delivered record sales of $26.1 million on year-over-year growth of 17% on a reporting basis and 21% on a constant currency basis. This strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MACE forward as a standard of care in each region and major market in the world. During the quarter, we also finalized a new French CEPS agreement that provides for adjusted rebate tiers and successfully expanded the addressable patient population to reflect the growing adoption of a high-spend inject W in France. The net effect of this new agreement was favorable to our second quarter reported revenues and is expected to remain a tailwind for the remainder of 2024. While we remain in the early stages of expanding our IG initiatives globally, our efforts are progressing well, evidenced by several recent international regulatory approvals, including for iStent and JECW in China and standalone usage indication for iStent and JECW in Japan, alongside the approvals of both iStent Infinite and Preservo in Brazil earlier this year. And finally, our Cornell Health franchise delivered sales of $19.8 million on 7% year-over-year growth, including Fortrex immense sales of $16.7 million. As discussed last quarter, our second quarter results reflect the impact of Fortrex realized revenues as a result of our entry as a company into MDRP. Shifting gears, we continue to prudently invest in and successfully advance our pipeline of novel promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. This includes Epioxa, our next generation corneal cross-linking therapy, for which we continue to progress towards data readout in the second half of this year for the second phase three pivotal study supporting our NDA submission that remains on target for the end of 2024. Beyond Epioxa, we also continue to make encouraging progress across our robust portfolio of clinical and preclinical programs focused in the areas of glaucoma, retina, and rare disease, where our milestone targets and associated timelines remain on track and unchanged versus previous disclosures. We remain excited about the significant potential value that we believe our pipeline programs may create. At the same time as we discuss, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending and our capital position now and in the future. On that front, during the second quarter, we opportunistically executed a transaction to exchange $230 million in principal amount or 80% of our convertible senior notes due 2027 for common stock, helping to further solidify our already strong capital position through a deleveraging and de-risking of our balance sheet, as well as significant reduction in future cash interest expense This convert, originally issued in June 2020 during the height of the pandemic, has proved to be a beneficial financial instrument that provides us with the financial flexibility to continue investing in our pipeline through COVID and other reimbursement-related uncertainties. In conclusion, I'm pleased with the strong commercial development execution of our teams that have demonstrated so far this year. We look forward to continue to build upon the growing momentum in our business over the course of the coming quarters and years. Our foundation is strong, and we are ideally positioned to continue transforming vision for the benefit of patients worldwide. So with that, I'll open the call for questions. Operator?

All right. And just as a reminder, to ask a question, please press star followed by the number one on your telephone keypad. Our first question comes from the line of Tom Stephan from Stifle. Please go ahead.

Great. Hey, guys, thanks for the questions and congrats on a nice quarter. Maybe I'll start with Eidos. Any comments on 2Q24 sales contribution or instead maybe any color on the base biz growth in U.S. glaucoma if you prefer to give that. And then if you could also comment on 3Q trends you're seeing with the J code now in place, that'd be fantastic.

All right. Thanks, Tom, and thanks for the comments. Not even a softball warm-up before we dive into the iDose questions, but happy to start there and then we can take it further as you guys deem. I'll start with the overall U.S. glaucoma performance. Obviously, Tom alluded to the strength there with growth once again accelerating in the second quarter to 26% on a year-over-year basis. And that was driven both by mid-teens growth yet again from our iCent portfolio and and infinite standalone utilization in particular, alongside better than expected contributions from Eidos TR. I think the second part of your question is we think about the third quarter with the J code in place, and now we've kind of worked our way through the first month of that. I think it's important to say, I mean, obviously we continue to be positive about the progress we're making with the iOS launch in general, a ton of which happened in the second quarter as we make our way through July, that continues. In some respects, Q3, as we've said all along, is a bit of a, I'll call it a reset moment as you get the J code in place. And on the positive side, you'll have some accounts where their administration will now allow those first cases once the J code has been established entering the quarter. You know, frequently, though, you also need to see that get billed and ultimately see reimbursement working before you'll fully open that up. And those same dynamics hold true for many of the accounts that did their first procedures under this latest code during the second quarter. So I think as we make our way through here, you hope to continue knocking down those hurdles and really see that momentum build from where we were at, certainly in the first half of the year.

Got it. That's great. So just as a quick follow-up, if I dial in maybe 16%, 17% growth, in the core U.S. glaucoma business. I'm arriving at around, call it 9 million of idoses. Is that fair? And then my follow-up would just be just on profitability for breakeven on a cash flow basis. Is at some point in 2025 for total company, maybe a reasonable target as we think about idose secretion, you know, really starting to take hold in a more meaningful way. Thanks for taking the questions.

Yeah, thanks, Tom. I'll start, and then I'll turn it over to Alex for the profitability side of that. I don't think the math that you did there, I know you're trying to do it on the fly as we're doing that, guys. I don't think the math quite shakes out that way, so you can redo that. I'm not going to comment and endorse a specific number on it other than just to reiterate what we said when you kind of look at the overall growth profile of the business driven by mid-teens growth from ISET portfolio and the rest being, you know, larger than expected contributions from IDOS.

Alex, you want to talk about profitability? Yeah, on profitability, Tom, it's obviously a great question and top of mind. And so as we look forward, we've always said that the company would look at profitability and on the other side of Eidos, we're getting there. And to your point, you talked about 2025, and that's going to be a key year for us as far as Eidos ramps up. Our goal internally, to be quite frank, is to get back to a place where we are getting to cash flow break even and then starting to generate cash as opposed to having to focus on profitability in the near term. As Tom mentioned in his opening remarks, we've got a rich pipeline. There's a lot of value there. There's lots of investments to be made, but we really would like to get back to cash flow break even and then start to build up that cash flow over time.

And I do think in 2025, we should start to see some of that occur. Got it. Okay.

Sorry, I'm going to cut you off a little bit, but our next question comes from the line of Larry Diegelson from Wells Fargo. Please go ahead.

Hey, good afternoon. Thanks for taking the question and congrats on a nice quarter here. Joe, if I look at the midpoint of the guidance range, it appears, you know, the growth rates are pretty similar in the first half and second half. Why wouldn't growth be higher in the second half, given the ramp of high dose? And I guess is your commentary on the J code earlier? that I do sales, you're not expecting to go up sequentially in Q3? Thanks.

Yeah, thanks, Larry. A couple things to unpack there, you know, as it relates to the guidance and seasonality. I mean, obviously, as you alluded to, we're super pleased with how the first half of 2024 shaped up, and then we were able to raise our, you know, As you look to translate that into, I'll call it our growing momentum, into the second half, I want to point to a couple key things. First, the normal considerations around Q3 seasonality, which I'm happy to elaborate on more, and the FX headwinds that we called out as a part of our press release. You're also fairly aware of the continued impact of the MDRP as a headwind to our cornea franchise, with the most significant of that impact likely expected in the fourth quarter. When you think about IDOS TR and the growing focus on our commercialization there, we want to be a little bit cautious that as we clear the expected market access headwinds and hurdles, if you will, It may dampen some of the performance we've seen out of the stent portfolio in the first half as our sales organization leans further and further into, obviously, the IDOS launch. And the last thing really is kind of what I alluded to with Tom's question, which is the third quarter being a bit of a JCO transition quarter. It's really hard to pinpoint in such a small and precise period of time, Larry, when you're in a launch like this. You know, the reality is that the sooner some of these things start to play their way through from a payment standpoint on the JCO in the quarter will accrue some more benefit in this quarter. But it's hard to nail that down in the context of such a precise period of time. All I can really say is that as we look at the overall launch thus far, we're increasingly confident in where we're headed with this product and what it's going to mean, certainly, as we get into the fourth quarter and translate that into 2025 and beyond.

That's helpful. I hate to do this, but a math question, Joe, another way of looking at it, you know, U.S. glaucoma sales were up about 4 to 5 million sequentially in Q2 last year and the year before. This year, U.S. glaucoma sales are up about 8 million sequentially. Should we just assume the difference this year versus prior years is primarily, you know, eye dose or roughly 3 to 4 million sequential increase in eye dose? Thanks for taking the question.

Yeah, sure. I mean, I think there's a handful of ways that you could try to back into the specific number that's there. I think that where you're headed on that is probably closer to reality than, you know, I think the early map that was suggested before. But most importantly is that we made significant progress the second quarter with IDOS. And that's while having, obviously, the position of miscellaneous C code in that environment there. So, again, that combined with the continued clinical feedback that we've been receiving really drives that confidence we've got and how that's been translated into the increased guidance that we gave today.

Thanks for taking the question.

All right. Our next question comes from the line of Ryan Zimmerman from BTIG. Please go ahead.

Hey, guys. I'll keep the fastballs going and not give any softballs there. So, you know, Tom, I want to ask about your conversations, your early feedback on the readministration potential with IDOS. Do you know at this point whether you needed a trial for that? Kind of where do they stand on your existing data? They include, obviously, readministration. Anything that you can kind of share with us at this point that maybe, you know, you know, sets up your outlook on that potential.

Yeah, I'd be happy to do that, Ryan. So, um, as you know, we we've talked about, we've submitted the reconsideration request. We'll begin an active dialogue with the FDA, which I, which I presume will be over the next several months. They don't have a statutory obligation to respond to us in a specific period of time. And so they're not bound by typical in positions that we may go back and forth as we look at this over time. I think as I've talked about before, it was kind of a late stage in our mind, the decision by the FDA to restrict us to a single administration. So we didn't have the opportunity to make the fulsome case at the tail end of the NDA adjudication prior to our successful approval. So now we have that opportunity. So the short answer is no, we don't need any additional clinical trial information or clinical trial performance to be done. I think what we need to do and what we are doing is presenting the narrative in a compelling case given the data that we've already been able to perform and have available. I think we have a strong case. Having said that, we know that the overt conservatism of the FDA, we suspect, drew the initial decision. I have been countencing both investors and analysts to let's not get over our skis here. We're hopeful. We may not be able to make progress, but we're not counting on it. So we'll make every successful effort to apply for re-administration of the IDOS device. And what I've said before, and I believe, is that we have a belt and suspenders approach here. If we're successful moving forward with IDOS T-Rex, which we're on track to begin the clinical trials by the end of the year, if you do the chronology, I suspect we'll be in a position to become a de facto device and a procedural pharmaceutical re-administration component for those patients that have served the full term of their initial high-dose device. So I like where we're at. I like how we're approaching this. I think we will make a strong case, and then we'll see. And I clearly will keep both you and the investment community informed once I've received a final decision from the FDA.

Okay. And then my second question is just around what you're seeing today with adoption of Eidos. And what I want to understand is, are you seeing competitive switches from Darista? Are you seeing the adoption of Eidos either before drops, after drops, before SLT? Can you just kind of talk about where Eidos is shaping up in kind of that treatment paradigm? Thank you for taking the question.

Yeah, Ryan, I'll start, and Tom may want to add color on this, too. You know, from our standpoint, I think it's a little bit early to be making, you know, grand calls around exactly when and where it's being adopted. But I'll comment a little bit on where we expect it to be adopted. And from that standpoint, you know, when you think about the label that exists with IDOS, we would expect it to be, you know, a early option for intervention in standalone patients regardless of their disease severity going forward. And to your point, I think each surgeon will have a different view on the algorithm in which they deploy it. Some will likely, you know, follow SLT. Some will follow Drista. Some will put it in front of that. But I think in general, what you're seeing with the overall interventional glaucoma shift is a mindset towards more proactive therapy for these patients and not relying on disease progression following years of increasing drop therapy. And I think all parties will benefit from that, and in particular, IDOS-TR and Glaucoma.

Thanks, guys.

Our next question comes from the line of Matthew O'Brien from Piper Sandler. Please go ahead.

Hey, this is Phil on for Matt. Thanks for taking our questions, and congrats on the record quarter. Just for starters, I think Q1 saw 15 total implanting surgeons with about six weeks total of rollout. Any update on the implanting surgeon base in Q2? Just to keep the quick math train rolling here, I think we triangulated about just under one eye dose per surgeon per week in Q1. Is that the right way to think about things, especially in Q2?

Yeah, so I think, Phil, what I would say there is that pretty much everything with the launch has gone exactly as we planned and exactly as we told you we intended to execute. Of course, anything can happen, but so far, so good from that standpoint. You know, across the board on the market access-related items, you know, we've seen the facility fee turnovers in Q2, the JCODE in Q3. We're making, you know, professional fee progress. We saw the first of which to the schedules in the Noridian region come out this past quarter. So the wheels of progress continue to grind on each of those fronts. If you think about it from a commercial sales standpoint, we opened up, you know, our early access program, which is what you were referencing when we had a planned sort of launch with the top 10 to 15 surgeons in the first quarter. We've opened that up to our entire U.S. glaucoma sales force in the second quarter, as you heard Tom reference. And we saw a lot of progress as a part of that as referenced or as seen in our evidence by our early results. you still have the headwind of practices that are comfortable with the gymnastics required with executing against the miscellaneous drug code. And so I wouldn't underestimate that. And I just think that taking a step beyond that in the context of how many surgeons have been trained and the average procedures per week, I think it's just a little premature for that. That's something that we'll start to get a much better handle on the trending of and decide how we communicate with that to you all as we kind of make our way through the year and start heading into 2025.

That makes sense, thank you. And then just my follow-up on iDose, as the excitement grows beyond it, call it friends and family and the broader glucose user base, any competitive NIGS switches pulled over by iDose adoption from competitors and thoughts on maybe a core spent halo effect that you might see as iDose adoption grows?

Yeah, I mean, I think that in general, We've invested an awful lot of capital and time to generate an exceptional amount of data that surrounds all of our products. And whether that be the legacy, you know, Ice and Inject in combination with Cataract or Ice and Infinite and now iDose. I think the totality of that portfolio is pretty compelling to practices as they think about the evolution of their care for these patients. And I certainly hope that we're benefiting from that. And as you referenced the sort of halo effect, the ability to treat patients first and foremost with IDOS, and ultimately as the disease progresses with isodinfinite is a pretty compelling value proposition that I think we're just now beginning to capitalize on.

Thanks so much.

All right. Our next question comes from the line of Alan Gong from J.P. Morgan. Please go ahead.

Hi. This is actually Rohan on for Alan. Thanks for taking our question. I was hoping that you could elaborate a bit more on what you meant by reset in third quarter. Obviously, I understand the JCO transition. But in light of that, when do you kind of expect to get to a full launch for IDOS? And what are kind of expectations around run rate exiting 2024 into 2025?

Yeah, Rowan, it's Joe. I think first I'll start with the elaboration on it. A launch like this, there's rarely a single black and white event that creates the unlocking. I think the J code, as we've always alluded, is an important component of that. I think as you get into the fourth quarter and you have the J code with the published ASP, that's an important component of that. As the pro fees continue to be established and become more solidified, that's an important component of that. And I think as you continue to move forward, quite frankly, as I said earlier, you know we're going to have more accounts i think start to open up we've already seen that where they're just more comfortable operating the j code environment than a c code but they're still going to want to see a payment or two before they really allow the surgeons to run and do what they want clinically so you have to kind of overcome that that first basic hurdle and establish reimbursement confidence whether that's through the payment of the miscellaneous c code and those claims are outstanding or it's the payment of the J-code as we get going. Sitting here today, obviously, for those folks who've done procedures in the month of July, they'll have just now been submitting those, and those things will start to be adjudicated and paid over the course of the quarter. And it gets very difficult for us to then translate how quickly that also translates into increased surgical volumes and clinical adoption based on the clinical merits of the product versus the, I'll call it the reimbursement confidence piece. And And that's why you've heard us consistently say that the third quarter is a positive step in the right direction, but it is a transition into what we think will translate into growing momentum in the fourth quarter going into 2025. I probably stopped short of quantifying that specifically, but if you think about your models and you're working on our guidance and what we've implied through the commentary for the third and fourth quarter, I think that starts to give you a sense of what that means for IDOS as we exit the year and enter next.

Great, thank you.

Our next question comes from the line of Harrison Parsons from Stevens.

Please go ahead. Hi, good afternoon. This is Harrison. I'm for George, and thanks for taking the questions. I wanted to start on your guidance and specifically the domestic glaucoma revenue segment of that. I was wondering if, for the remainder of 2024, if the base stenting business We should expect that same mid-teens growth and then, you know, whatever is incremental, that should be from iDose. Is that the way we should be thinking about it?

Well, Harrison, I think I might make a slight tweak to what you just said. I think it was asked a little bit earlier. One of the things that we're anticipating or at least preparing for as a part of providing guidance today is is that as our team increasingly focuses on the idos tr you know commercialization you know that could create some um growth uh headwinds if you will relative to what we experienced the first half in our broader portfolio in the us glaucoma so it's a different way I think we've seen, obviously, a strong pattern emerge in the first half of mid-teens type growth in our STEM portfolio. And I'm not sure that we're counting on that, obviously, as we make our way through the second half and the attention increasingly turns to IDOS-TR. I do think I can provide a little bit more color in terms of the directional growth by franchise to help here. I think as we think about it for the full year and the revised guidance, I would expect the cornea business to deliver low single-digit growth for 2024, and I'd expect the international glaucoma business to continue along the strong trajectory it's had and to ultimately deliver low to mid-teens growth for the year, reflecting the strong first-half performance. And if you do that math, it implies U.S. glaucoma year-over-year growth of sort of the high 20s to approaching nearly 30% on a year-over-year basis. for 2024.

Okay, got it. Yeah, that's helpful. So I wanted to move towards the Salesforce strategy. I know you've talked about a phased launch there. I know all of your reps are calling on surgeons now, but could you give any more color on how many surgeons each rep is going after? Is it just their top one or two? And I guess what I'm really asking is when When are we going to be at a full sprint there with all of your Salesforce going out to all of their accounts?

Yeah, sure. And every member of our sales team will find themselves in a slightly different part of their own trajectory as it relates to the launch. But the way I would characterize it is what we said in the last call. You start off by enabling the first handful. For some, it's one or two. For others, it's a couple more surgeon targets. Getting comfortable with that, getting the sea legs associated with launching a product like IDOS. And then ultimately, as we get into the third quarter, you start to open that up in waves. Again, at this point, it's a little less focused on the exact number of surges that we're enabling with the sales force. And I think the unlocking, if you will, of it has a lot more to do with when they start to see the payment flow through of the J code. And for those who've already done it under the misplaced C code environment, the C code.

Great. Thanks for taking the questions.

Our next question comes from the line of Margaret from William and Blair. Please go ahead.

Hey, guys. Good afternoon. Thanks for taking the questions. I'm going to keep on the IDOS train, at least for the first one. As we think about the number of accounts that have implanted IDOS and the doc trainings that you've done on the back end, you're sort of referencing the JCO and all these catalysts that should hopefully unlock more of those. A, do you expect a meaningful increase in implanters versus kind of what we saw in the Q2 case? And then at what point do you hit a consistent quarter run rate for doc training or, you know, you've got kind of infinite capacity, you know, no pun intended, where that can go?

Thanks, Margaret. I'm going to sound a little bit like a broken record, I think, here, but in many ways, the gating item here to that consistency, I'll call it of the ramp and the number of doctors being trained in any given quarter, et cetera, is really based upon when we start to see the consistent and recurring and predictable payment of the JCO. And we expect that in relatively short order, let me be clear. But from that standpoint, as you enter into the third quarter, it's a normal grinding of the process, if you will, as the max, for example, bring the J code online as they start to adjudicate these things and pay them in a, in a, you know, more typical payment cycle that the account can count on. At that point, administrators stop becoming the ones who are dictating access to the product, and it becomes adopted from the clinical side, and the things that we all know, the benefits that we all know exist for utilization of IDOS-TR. And that's the reason why I think when you all do your surveys, you see such positive feedback from the surgeons who are thinking about it from a clinical standpoint, how they would adopt that. And I think as we get ourselves, you know, through the third quarter and certainly as we enter into the fourth quarter and exit the year, I think we're going to start to see a lot more clinical adoption versus, you know, I'll call it market access or reimbursement related conservatism.

Okay. And then, you know, I'll switch over to Infinite because you guys, you know, you keep referencing the success of that. Is it fair to assume that Infinite still remains larger than iDose at this point or not? And then, you know, as we think about what's driving that interest for Infinite at this point, can you talk to, you know, types of accounts, number of accounts that have adopted, and how or what is in your guidance over the course of the year that's implied? Thanks.

Absolutely. I mean, I think first, Absolutely. Our STEM portfolio and iSTEM Infinite remain the dominant component of our overall portfolio. If you just think back to what I said earlier in the call, with mid-teens growing on a year-over-year basis, U.S. glaucoma revenue basis that exists today. Now, I do expect, and we all do expect, that will shift pretty quickly here as IDOS continues to ramp. But as we sit here today, Infinite is still the largest contributor to the overall portfolio on the U.S. glaucoma side. You know, what's driving it? I think it's exactly what it's intended for. You know, as we enter into this year, and coverage was there and established in a much more predictable recurring way our customers started to focus on the intended use case of the product which is for those patients who fail you know surgical medical therapy and if you think about it for those patients it just makes sense to intervene first with infinite before moving on to more invasive procedures is what you'd want for for your your family member in the same situation i think as our sales customers, you see more and more adoption of our surgeons utilizing exactly as it was intended.

Okay. Thank you, guys.

Our next question comes from the line of David Saxon from Needham. Please go ahead.

Hey, guys. This is Joseph for David. Two questions, I guess, on the high dose, and I'll just ask them together. gross margin improvement how much of that was maybe driven by idos um and then looking just like towards the launch throughout the rest of the year is there any plans on you know hiring on the back of the idos launch um you had mentioned maybe that the broader portfolio could see some headwinds from attention there so i was just wondering if that was um you know contemplated in the plan

Okay. Hey, Joseph. It's Alex. I'll take the first question on the margin. So, we did have a little bit of a modest year-over-year increase in margin. It fell within our expected range of 82% to 84%. And so, I wouldn't say Eidos was a major driver of that. In fact, quite honestly, you know, the Eidos facility that we turned on tends to be right now a headwind to our margin. as we tend to see these inefficiencies in manufacturing as you scale up production on these product launches. So at this point, we expect to see the margin creation continue to expand over the course of next year on the back of the I-DOS as it fully launches.

And as it relates to the sales force and hiring plans, I think we've always been consistent in how we look at this, and we're going to stay true to the same approach we've had for a long time now, which is We're always evaluating territories and opportunities where territories get to a scale that it makes sense to grow our sales force. We have no plans as it stands here today to make wholesale changes to the size of the structure of our force, but I would expect that over time, organically, we'll be adding folks to support the needs of the glaucoma business.

Okay, great. Yeah, that's all from us, and congrats on the record quarter.

Thank you. Thank you.

Our next question comes from the line of Joanne Wunsch from Citibank. Please go ahead.

Good afternoon, and thanks for taking the question, and congrats on the quarter. I want to shift gears just a little bit to OUS MIGS. I'm curious what is going on there that's driving, you know, let's call it XFX 20% plus kind of growth. And also, if my memory is correct, when you gave initial 2024 revenue guidance, it was for that segment to be up low to mid-teens. Seems like that may need to be updated or the second half is really going to have a problem. Thank you.

Yeah. Hi, Joanne. I'll start on the latter first. When we started the year, what we said, or at least on the last call, was that you should expect low to mid-double digit growth from that international business. And on this call today, I referenced low to mid-teens growth. So, in fact, for the year, that does imply a step up in the overall growth profile. You know, I can point to a couple things. You heard Tom reference, obviously, the French agreement. But I think the biggest thing there continues to be the blocking and tackling of our teams across the markets out there. We're still in the relatively early innings of changing the standard of care. in the combination cataract market in many of these areas. And we're just now starting to turn on new product introductions and approvals that you heard Tom reference, as well as beginning to follow that with increasing focus on the interventional glaucoma opportunity and standalone care of these patients proactively, just as we're doing here in the US. So I think we continue to be enthusiastic about the opportunity outside of the United States and in these international markets. Having said that, you've always got currency considerations there. We have competitive launches. We've been dealing with that for the last couple of years. We continue to see that now, and that takes time to work through as folks try and trial and hopefully ultimately come back to products they know and trust in the Glaucos portfolio. So we feel confident about where we're headed with that franchise, and I think the increased guidance in that area reflects that.

Thank you for that. And the timeline for bringing Eidos outside the United States, what would that be? And have a great evening.

Thanks, Joanne. Yeah, from an IDOS standpoint, the first thing you do is get the approval in the United States, and that was the focus. And then from there, you shift your attention, in our case, to evaluating various markets internationally. That's a complex environment, as you know, in the context of the world where reference pricing and things like that exist. And so I think we'll be cautious about how we approach IDOS TR and the timing of any market entries. outside the U.S. for now, but we'll keep you updated as we continue to make progress on that evaluation.

Our next question comes from the line of Rich Newiter from Truist Securities. Please go ahead.

Hi. Excuse me. Thanks for taking the questions. Maybe just going back over the component of the, you know, the bridge, the guidance range from old to new. You gave some color there. I just want to make sure I'm getting all the pieces correct. It sounds like international glaucoma has a bit of a call-up. You just said low double digits to low to mid-teens. And obviously, your U.S. glaucoma is now high 20% to low 30%, and that's a call-up too. But it sounds like that you're getting some of the maybe the incremental I-dose contribution masked by commercial sales, not distraction, but

time trade-offs from from the rest of the glaucoma portfolio is there anything else in there did i get the pieces right can you put any quantification around those yeah so i think taking a step back um just to confirm the first part of what you said i think the the punch line is in the the revised guidance It's guiding up on the international side. It's guiding up on the U.S. VACOMA side. And, you know, from a macro standpoint, if you think about it, we beat the quarter, I think, by something like 7 million. And when you look at the midpoints, we raised our guidance by 12. And so all of that is incremental as we think about the overall growth profile of the business. You know, from the cornea side, yeah, The low single digit is probably a tick down from where we were at on our prior calls, all really related to our entry into the Medicaid Drug Rebate Program, which we've talked about on previous calls. I think from a U.S. standpoint, you largely captured that right. What I said was, you know, as you can imagine, our sales force is going to be increasingly leading into the IDOS-TR launch. It's going to take an increasing amount of their time as they're turning on and training surgeons as we make our way through the second half. And while I hope this doesn't happen, we're preparing for, financially in our guidance, some dampening of the growth profile that we saw in the first half in our STEM portfolio.

Got it. That's really helpful. And, you know, appreciate you're not giving us the specific IDOS number for 2Q, but I Whatever that number is, call it four, whatever it may be. In an ideal world, if you were in our shoes, would you ideally like to see the consensus modeling roughly flattish, kind of sequential, and then a big uptick in 4Q or spread it out a little bit, slight uptick 3Q, bigger uptick 4Q? Any kind of directional help there? It might help calibrate consensus relative to where you might want it.

Yeah, I mean, I think it's a good question. So if you just focus and zero in on seasonality, not with any specific product in mind, but just seasonality of the business. As you know, the underlying procedure demand tends to favor Q2 and Q4 over Q1 and Q3 in ophthalmology in general. In recent years, we've seen a sequential Q2 to Q3 step down of several million dollars. And I think we would expect that at least to be the starting trend line again this year. As you've heard me say, the relative next leg up from an IDOS growth standpoint is likely to be weighted more towards Q4, as we've indicated, you know, for some time. As I also mentioned, it's really hard when you're the way that the launch lines up. to be quite so precise in the context of exactly what will accrue in the third quarter versus the fourth. And so I think from that standpoint, it makes sense for us to be a little bit conservative while we're obviously planning for, you know, more optimistic outcomes both for the third quarter as well as including the fourth.

Okay, thanks. Congrats on the quarter.

Thank you.

Our next question comes from the line of Steve Lichtman from Oppenheimer. Please go ahead.

Thank you. Evening, guys. I wanted to actually ask, just on U.S. corneal health, I appreciate all of the full-year guidance. How should we be thinking about that business after you anniversary the MDRP? Do you anticipate it picking up, or do you have some device-related headwinds as we get closer to Epion? How do you think about that as we move past this?

Yeah, it's a good question, Steve. I think from the corneal health side, you set it up correctly. First thing you have to do is sunset some of the Medicaid drug rebate program entry headwinds. Some of those could persist into 2025 as well, as that adoption in the Medicaid arena continues to grow and the rebates grow alongside of them. But as we get past that, from a, I'll call it a gross to net adjustment standpoint, Now, our expectation is that the underlying business X that dynamic should be returning back to or exceeding the kind of growth that we've expected in the past from that franchise and what you saw in 2023. Ultimately, a lot of the activities that we are doing and will do would be in anticipation of preparation for a very important launch in the Epioxa product as we exit 2025 and enter into 2026.

That's helpful. And then, positive if I missed it, but how are you thinking about OPEX growth now exiting here to Q for the year? Thanks.

Hey, Steve. It's Alex. I'll take the OPEX question. And again, our OPEX is trending along exactly how we were trying to guide it for the year. If you recall, we had said to expect OPEX to – grow this year around 10% and off a base of about $360 million from last year. That puts you at a full year OpEx around $400 million. Through the first half, we have spent $192 million. So if you just sequentially take a little modest step up over the next two quarters, you can get to the $400 million, and that's what we'd expect for the year.

Got it. Thank you, guys.

Thanks, Steve.

All right. And our last question comes from the line of Anthony Patron from Mizuho. Please go ahead.

Thanks. I'll stay on the IDOS theme here. And first question will be on the strategy for the 20% Medicare fee-for-service patients out there, just doing some checks. And there's a little bit of, obviously, sticker shock with the out-of-pocket for those patients in the instance where you have to use two stents. So is there a balance sheet strategy to sort of close that donut hole in that 20% Medicare fee-for-service strategy? And then just as we look out in terms of, you know, I-DOS getting into the S-curve with its product launch, you mentioned potentially some Salesforce ads, the $400 million. Is this a scenario once we get to $25 and certainly into $26, the Salesforce addition sort of level off and you really start to see that leverage benefit in the middle of the P&L? And is that sort of the right timeframe for that? Thanks.

Yeah, thanks, Anthony. I think first let's take a step back, something I think we've talked about on prior calls around the payer landscape. And obviously all of this was factored into the significant amount of work we did in arriving at the price point for IDOC-R and looking at it from an access standpoint in that context. You have to break it down into the three constituent parts. For traditional Medicare fee-per-service, I think that's what you were referencing with the 20% comment. For those patients, the vast, vast majority of them actually have low to no out-of-pocket because of secondary insurance coverage. So from that standpoint, access for the vast majority of those patients really shouldn't be limited based upon the price point that you're talking about. The second group that I'll focus on is the commercial patient population. And for that, I think where you were referencing the balance, et cetera, you should expect that, yes, we will have a copay assistance program like all drug companies of similar price drugs to take that burden off the table for those patients that have commercial insurance. So from that standpoint, the access to that will be gated much more by the policies and coverage of those payers and not so much the out-of-pocket dynamics that you're referencing. The last group will be the Medicare Advantage. That's not unusual to us versus any other pharmaceutical or device companies out there where a significant portion of those patients both will be subject to the burden of policy restrictions as well as relatively high deductible plans. And for those patients, you tend to see them get treated more often than not in the later stages of the years when they've actually eaten through their out-of-pocket maximums through other procedures earlier in the year. And so we'd expect for that patient population to wait more towards the back half of any given fiscal year. As it relates to the IDOS sales force, I think maybe I want to clarify something there. When I talk about organic ads for us in there, I really do mean nothing wholesale. Ophthalmology in general and certainly surgical ophthalmology, there's quite a bit of leverageability in that. So while we'll continue to be smart and prudent about supplementing that resource where it's needed throughout the country, We're not talking about something that scales infinitely or that overnight rapidly changes alongside the Eidos launch. So our expectation would be that you would start to see the leverage, if you will, I think the way you asked the question, sooner rather than later as it relates to the Eidos and the launch in our sales force.

Very helpful. Thank you.

All right. I would now like to turn it back over to our team at Glockos for closing remarks.

Okay, I want to thank everybody. Thank you all for your time and attention today, and thank you for your continued interest and support in Glockos. Thanks and goodbye.

That concludes today's conference call. Have a pleasant day.