Glaukos - Q1 2024

Transcript

Operator (participant)

Welcome to Glaukos Corporation's first quarter 2024 financial results conference call. Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question, simply press star followed by the number one on your telephone keypad. To withdraw your question, press star one again. This call is being recorded, and an archived replay will be available online in the investor relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Chris Lewis (VP of Investor Relations and Corporate Affairs)

Thank you and good afternoon. Joining me today are Glaukos 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, the state of the company's business objectives and strategies, and any forward statements or 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, 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 cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investors section of our website at www.glaukos.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 Glaukos's ongoing results of operations, particularly when comparing underlying results from period to period.

Please refer to the tables and our earnings press release available in the investor relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos Chairman and CEO Tom Burns.

Tom Burns (Chairman and CEO)

Okay. Thanks, Chris. Good afternoon, and thanks to all for joining us today. Today, Glaukos reported record first quarter consolidated net sales of $85.6 million, up 16% versus the year-ago quarter. As a result of our strong start to the year, we are increasing our full-year 2024 net sales guidance range to $357 million-$365 million versus $350 million-$360 million previously. These record results were broad-based, with 20% year-over-year growth achieved in both our U.S. and 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.

These efforts were on full display at the AGS conference in late February and more recently at the ASCRS meeting last month, where the interest and excitement levels for interventional glaucoma and our technologies were palpable. Within our U.S. glaucoma franchise, we delivered first quarter sales of $42 million on strong year-over-year growth of 20% driven by iStent infinite and our overall iStent portfolio. Market receptivity and adoption of iStent infinite remained strong as we continue to pioneer and lead the interventional glaucoma paradigm shift. In parallel, we continue to advance key market access initiatives to support consistent and dependable professional fee payment with five of the seven MACs, now including CPT code 0671T, on their latest fee schedules.

During the first quarter, we also commenced the initial phases of our controlled launch plan for iDose TR, our revolutionary microinvasive injectable therapy designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. iDose TR is a first-of-its-kind intracameral procedural pharmaceutical designed to deliver glaucoma drug therapy for up to three years. I could not be more pleased with how the early stages of this launch have gone. Our initial target wave of 15 surgeons all successfully completed their initial iDose TR procedures during the first quarter, and their early feedback and outcomes have been very positive. As a reminder, these early access surgeons provide valuable insight to our training and field teams that helps to optimize training and skills transfer to our salesforce and surgical community, supporting our expanded training and broader launch efforts over the course of 2024.

In addition to training, a key element to the stage-gating of our iDose TR commercial launch is market access, where there have been several recent positive reimbursement developments designed to support fulsome coverage and payment for the iDose TR procedural pharmaceutical over time. So first, CMS assigned a unique permanent J-code for iDose TR, J7355, set to become effective on July 1st, 2024. This new J-code, once effective, is expected to increase patient access here in the United States and should provide more streamlined, consistent, and dependable coverage and payment for iDose TR as we advance and ultimately accelerate our initial commercial launch activities. Second, CMS assigned the CPT codes that are designed to be used to cover the procedural component of iDose TR, 0660T and 0661T, to Ambulatory Payment Classification, or APC 5492, effective April 1st, 2024.

This translates into a national average facility fee of nearly $3,900 in the HOPD setting and more than $2,000 in the ASC setting. Third, we have participated in several initial education meetings with MACs as part of our efforts to secure professional fee coverage and payment over the course of 2024. Fourth, we successfully entered into the Medicaid Drug Rebate Program, or MDRP. Finally, fifth, we have successfully commenced early initiatives to secure coverage for commercial and Medicare Advantage plans, efforts that we plan to accelerate in the second half of 2024 after the J-code is effective.

So in summary, the response we received from surgeons in the broader ophthalmic community since FDA approval and the more recent initial commercial launch activities has been overwhelmingly positive and reaffirms our view that with the launch of iDose TR, we are pioneering a brand new category of procedural pharmaceuticals that has the potential to reshape glaucoma management as we know it today. We are excited to now be building the strong foundation to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension. Moving on, our international glaucoma franchise delivered record sales of $25.2 million on year-over-year growth of 20% on a reported 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 MACs forward as the standard of care in each region and every major market in the world. We remain in the early stages of expanding our IG initiatives globally ahead of what we hope will be supported by a healthy cadence of new product approvals and expanding market access in the years to come. And finally, our corneal health franchise delivered sales of $18.4 million on 4% year-over-year growth, including Photrexa sales of $15.1 million on a year-over-year growth of 7%. These first quarter results do include, in particular, the impact of our entry as a company into MDRP. These dynamics were anticipated and will continue to impact Photrexa realized revenues going forward.

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 trial completion in the second phase III pivotal trial and remain on track for data readout in the second half of this year, supporting our targeted NDA submission by the end of 2024.

We continue to make enrollment progress in several important clinical trials, including one, a PMA pivotal trial for iStent infinite in mild to moderate glaucoma patients, two, a phase II-A study for iLution Travoprost with an initial data readout expected later this year, three, phase II trials for iLink Third-Generation Therapy, and four, a first-in-human clinical development program for GLK-401, our intravitreal multi-kinase inhibitor retinal program in wet AMD patients. We also remain on track to commence a phase III study for iDose TREX, our next generation iDose therapy by the end of 2024. Beyond these clinical activities, our development teams continue to pursue potential game-changing early-stage programs across the areas of glaucoma, retina, and rare disease. So in conclusion, I'm pleased with the strong start to the year given our team's solid execution.

I'd like to thank the nearly 1,000 Glaukos employees who remain dedicated to their work in advancing our strategic plans. We look forward to continuing to sustain and build upon the growing momentum in our business over the coming quarters and years. Our foundation is strong, and our teams are energized as we are ideally positioned to continue transforming vision for the benefits of patients worldwide. With that, I'll open the call for questions. Operator?

Operator (participant)

At this time, as a reminder, to ask a question, press star one on your telephone keypad. Our first question will come from the line at the Tom Stephan with Stifel. Please go ahead.

Tom Stephan (VP of Healthcare Equity Research)

Great. Hey, guys. Thanks for the questions. Maybe I'll start on the guide. Can you maybe talk about what the changes are to the construct of the full-year revenue outlook? If we can begin there. And then is there any more color or, I guess, parameters you'd be willing to provide on what's baked in for iDose?

Joe Gilliam (President and COO)

Sure, Tom. It's Joe. Thanks for the questions, and I'll start off with the guidance. Obviously, we had a stronger than expected start to the year, and we were pleased to be able to raise the full-year guidance accordingly here just a couple of months after setting it for the year. I'll call it a couple of key considerations, I think, that are worth highlighting and then kind of hopefully draw to a conclusion in terms of the expectations by the franchise. First, it obviously is very early in iDose launch with the vast majority of the contribution expected in the latter part of the year. That hasn't changed. Everything that we've been doing so far in the first quarter is on track and on target, and we can, I'm sure, talk about that more later.

Some of the iStent growth that we saw in the first quarter, which was very strong from a year-over-year basis, is partially driven by the timing of the iStent infinite launch activities last year, which really accelerated in the second quarter. So I think as we move into the second and third quarters, the comp from an iStent standpoint starts to get a little bit more difficult. Third, obviously, we all know that FX rates and the strengthening dollar have been moving against many of us from a U.S. reporting standpoint. So we see an incremental 200 basis points of growth headwind on the international side as we move forward throughout the year based on those spot rates as they exist today.

And then lastly, as Tom mentioned in the prepared remarks, we do expect the MDRP entry-related headwinds to persist for our corneal health franchise throughout the year. So when you put all that together, I think we're landing in a place where our expectations for the cornea franchise are low to mid-single-digit growth for the year. The international glaucoma business, we tick up a little bit. I think the expectations there should be low to mid-double-digit percentage or teens growth for the year. And that'll land you somewhere for the U.S. glaucoma business in that high teens to maybe at the top end 20% type growth year-over-year. So hopefully, that gives you a sense of kind of the drivers of where we're at.

On your second question around iDose TR, I think at this point, we're obviously quite early. We were very pleased to see that in mid-February, as we told you, we would get going. So in the second half of the quarter, we were able to get kicked off with the early access phase of our iDose launch. As Tom mentioned, really pleased to see our initial 15 surgeons be able to complete their cases in Q1 in coordination with our sales and training and market access teams. That's how we'll continue to methodically launch and slowly expand in Q2 ahead of, obviously, the J-code being established in Q3 and the ASP publication in Q4, where we start to expect a meaningful acceleration in the iDose-related activities and volumes.

Tom Stephan (VP of Healthcare Equity Research)

That's a great caller. Thanks, Joe. Then maybe switching to the pipeline. Tom, you alluded to this a bit, but we did see in your proxy that the company is developing iDose trio, which appears might be an in-office version of the implant. If you're willing to share, can you elaborate a bit on the product, maybe the key details, sort of the portfolio fit, I guess, and then any timelines or milestones? Thanks.

Tom Burns (Chairman and CEO)

Yeah, I'd be happy to address that, Tom. And so I think it's inevitable as we look at the evolution of the pipeline that we'll continue to figure out ways and develop ways to have an even more minimally invasive and facile procedure. So having said that, I think it's incumbent upon us to develop a product that will be able to be even more micro-invasive than the current iDose design and have an applicator that will be able to really be able to put the iDose product through an incision site that's going to be able to be in the range of a 1.2 mm-1 mm incision, which really gives us then the opportunity to create a self-sealing construct for a temporal clear corneal incision.

I think that'll be important, particularly as surgeons move to in-office procedures, which we know that they will do and which is a compelling part of our strategic plan over the course of the planning period. So we are in the process of developing an applicator that will accomplish and achieve those goals. I would say the timing we'd be looking for would be probably in late 2025 for potential introduction. And I think that will then be timely with the effect of how we'll be moving forward to give surgeons the opportunity to be able to exercise the site of service in-office as well as the ASC.

Tom Stephan (VP of Healthcare Equity Research)

Got it. That's helpful. Thanks again.

Operator (participant)

Your next question comes from the line of Ryan Zimmerman with BTIG. Please go ahead.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Hey. Good afternoon. Congrats on all the progress. I'm going to follow up on Tom's questions that I'm sure a lot of people will be asking about iDose, but you gave us a little detail here on 15 surgeons kind of completing initial iDose TR cases. Now, many of us have been diligencing this, and it would seem as though there are maybe more surgeons out there, or at least there's a lot of excitement out there. Just to confirm, have you put iDose in the hands of more than the 15, number one? And then two, kind of how do you think about expanding beyond that initial wave of the 15 in the second quarter until kind of that J-code's effective? And are you gating adoption in any way or kind of holding demand before that J-code is effective?

Joe Gilliam (President and COO)

Sure. Thanks, Ryan. I think the answer to the number of surgeons who've had access, and I think a little bit you're reacting to the, number one, the overall enthusiasm for iDose TR and some of the pent-up demand for folks to get trained and get going with it over the course of the year. But the direct answer is, yeah, now that we're sitting here on May 1st, of course, we continue to expand. We're past that. The 15 number from a surgeon training perspective was as of the end of the first quarter. So you would expect us to continue to be slowly expanding that and providing more access to folks. At the same time, we're going to do so methodically.

As we talked about from the outset, I think even back to the iDose call in December, the way we will launch this product is those early access physicians expanding that very slowly and methodically over the course of the second quarter and then really starting to open that more broadly as we get into the second half of the year with the J-code being established. At the same time and in parallel, we are working with these accounts. And so simply because a surgeon maybe hasn't completed their first case does not mean that they're not in the funnel or if you're doing channel checks expressing their enthusiasm because they're being trained. Their back office, their administrative staff are being trained.

And so we're continuing to make progress really on all those fronts as we move forward into what we think will be a pretty exciting, certainly second half and most notably fourth quarter for this year with iDose.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Okay. Very helpful. And then kind of dovetailing off that, Joe, I mean, if you are in those accounts, I'm curious, what impact or pull-through are you seeing as a result of the iDose efforts on the base business? And if you could kind of tie it to this iStent infinite growth, particularly in the U.S., I mean, I would venture to guess that the market is not growing anywhere near 20%. And so are you taking share? Is the market growing faster now because you are spending more time in accounts? Just maybe you could elaborate on kind of the core MIGS business and the resulting impact from your efforts on iDose.

Joe Gilliam (President and COO)

Yeah. It's a great question. So I'll provide a little bit of color I think will help you triangulate in around the breakdown of the results of the first quarter for the US glaucoma business. We did see our overall iStent portfolio, including iStent infinite, grow in the mid-teens on a year-over-year basis. So the majority of what you're seeing not all. Obviously, we did have iDose TR and some of those early launch activities. But the majority of the growth that you're seeing, the tune of mid-teens growth, is coming from our iStent portfolio. I think it's of course very hard to dissect that down to individual percentage breakdowns. But I do think it's a little bit of all of those things that you mentioned, Ryan.

I think that we are growing the market because of, as Tom mentioned, we put a lot of muscle and effort into the interventional glaucoma paradigm shift. That's not something new. We've been working on that hard over the course of the last 15, 18 months in particular. And I think you're starting to see some of the benefit of that in terms of growing the overall market certainly faster than it would be if it was still restricted to the combination cataract setting. But at the same time, I also do think we're taking a little bit of market share.

And I think the fact that we're in there with multiple new exciting technologies that help expand the portfolio of alternatives for these surgeons, you can't help but benefit a little bit from that in the context of a halo, obviously, associated with the overall portfolio. I think that is playing out a little bit as we make our way through the year so far.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Thank you.

Operator (participant)

Your next question comes from the line of Larry Biegelsen with Wells Fargo. Please go ahead.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

Good afternoon. Thanks for taking the question, and congratulations. A really strong quarter here. So Joe, you raised the guidance at the midpoint by, I think, the amount of the beat. Why not more? And the Q2, the Q4 growth implied or implied growth is actually below the Q1 growth, I think, at the midpoint. Just lastly on this, how should we think about Q2? Are you comfortable with consensus of, call it, $88 million?

Joe Gilliam (President and COO)

Yeah, Larry. So I think in the, I'll try to take it in the order in which you asked it. But the context of why not more than the beat—well, over the course of the two months, I'm not so sure since our original guidance that things have changed markedly versus the expectations and what we saw coming into the year. We've executed on everything we expected to and done a little bit better than that. And so we wanted to make sure that that was reflected in the raised guidance. But when you think about getting ahead of that, so much of that, obviously, is driven by expectation around iDose in particular. And as I've said and we've said for some time now, that's for the most part a second-half phenomenon that we expect to play out.

So I'm not sure sitting here today, we would make a significant change to our expectations around iDose and what it'll do in the second half. But we certainly continue to execute against realizing that opportunity at that point in time. As you think about Q2, I alluded to this a little bit in the question around the guidance. Our first quarter did benefit a bit from two things. One, on the international side, currency was a little bit more favorable than it's going to be going forward. We see an incremental 200 basis points or 2% of headwind on that international growth number as we enter the second quarter than what we experienced in the first given the strengthening of the U.S. dollar. And second, we really more fulsomely launched iStent infinite in the second quarter of last year.

So from a year-over-year comp standpoint, it gets a little bit more challenging as we enter the second quarter and beyond than it was in the first from a growth standpoint. So I think you put those things together, and you'll see why and where we landed. The last thing I'll say on that is from a seasonality standpoint, when you kind of think about the overall guidance as you know, we expected our typical seasonality patterns to be a bit disrupted this year by the growing iStent infinite standalone and, of course, iDose utilization in the second half. And the net effect of that is, obviously, to shift a bit more the contribution of the year to the second half and in particular the fourth quarter.

If I were to try to put percentages around that, I might do something like the following: 23%-24% in Q1, 24%-25% in Q2 and Q3, and 26%-28% of the year in Q4. I think if you follow that, you'll get to a pretty good place in the context of the seasonality expectations that we have for 2024.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

That's helpful. Joe, just a follow-up on the iDose ramp. I mean, how should we think about the ramp, and what's going to cause that inflection in Q4? Is it the J-code coming into effect July 1st until we'll see an inflection in Q3? It sounds like the contribution in Q1 was relatively small. How do you see what's going to drive the adoption through the year? Thanks.

Joe Gilliam (President and COO)

Yeah. I mean, obviously, our expectations, I think, would be that the contribution in the first quarter was relatively small. I mean, we launched it in mid-February and gave early access, and we're on schedule for all that. I think we'll continue to expand that over the course of Q2. But to the heart of your question, there are really two significant unlocking events, if you will, from an adoption perspective. The first happens on July 1st when you have the J-code come into place. There's obviously a lag effect there in terms of procedures being scheduled and the execution towards that J-code. But then as you get into the fourth quarter and the ASP is also published, at that point, you have a much more, I'll call it, automated payment system from a Medicare standpoint.

When you have the established J-code and a published ASP, it really enables a much more normalized process for reimbursement at the account level. We expect that to be pretty important in the unlocking, obviously, of surgeons really being able to run and do iDose in all the patients that they think are appropriate for the technology.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

Thanks a lot.

Operator (participant)

Your next question will come from the line of Matt O'Brien with Piper Sandler. Please go ahead.

Matt O'Brien (Senior Research Analyst)

Afternoon. Thanks for taking the questions. Maybe just to follow up a little bit on Larry's question there on the performance of iDose in Q1. And yes, you're going to get a million iDose questions on the call. But if I look at if I think about the base business maybe growing somewhere in the mid-teens, if I back that out, I'm looking at somewhere around something like a seven-figure performance in the first quarter, as said another way, over $1 million. Is that about the right number? And that's just on 15 docs, right? Just kind of trialing it, trying to figure out the J-code. Is that in the ballpark?

Joe Gilliam (President and COO)

Well, I'm not going to get too specific in endorsing any one number. But obviously, you've got the overall growth of the U.S. glaucoma franchise, and you've got that the iStent portfolio grew in the mid-teens from a year-over-year standpoint. So you, as you've done, can do the applied math on that. I'll just reiterate what we said. I mean, at the end of the day, there were 15 in-planning surgeons in the first quarter. They had about half of a quarter to do those procedures in, based on the timing of our launch. And it was encouraging to see both, most importantly, the enthusiasm for the outcomes for those patients after they had done their initial implantations of iDose.

They managed to provide us exactly what we need, the kind of pearls and information that help us dial in our training and ultimately establish confidence with our sales force as they execute on a growing basis over the course of the next several quarters.

Matt O'Brien (Senior Research Analyst)

Got it. And then the follow-ups just on the profitability side. Joe, I think you said historically, once you guys launched that profitability, the gross margin was good this quarter. Should we expect that to dip a little bit as iDose ramps and then improve meaningfully going forward or nicely going forward? And then the spend also was much better than we were expecting just given all the activities around iDose here in the quarter. So can we start to see profitability start to ramp pretty meaningfully over the next maybe 18 months? Thanks.

Alex Thurman (CFO)

Hey, Matt, Alex. I'll go ahead and take those questions. So we'll start with gross margin. Yeah, we were pleased with the 83% in the quarter, for sure. But as we mentioned on the last call, and I'll say it again, as you know, when you launch a new product, it's bound to see some inefficiencies in the operations as you start to ramp up that product and the manufacturing and all the costs that are associated with that. So what we would tell you or what I would guide you to is some level of a range. We've always said 83%-84%. We hope to continue to play in that range this year. But there should be and could be some volatility as we go through the next couple of quarters and iDose gets ramped up.

Then we think about the margin being accretive over time with iDose, for sure. And we would look forward to that accretion and seeing some of that next year. On the operating side, you're right. We were pleased with the 92% if I back out the IPR&D charge of $11.7 million. So that was nice. The one thing I'll just say on the expense side is that in Q1 of last year, the R&D spend was much higher than normal because we had all of the iDose pre-NDA activities that were happening as well as a large PDUFA fee payment that needed to be made. And so that kind of explains a little bit of the slowdown if you were comparing on a year-over-year basis.

Matt O'Brien (Senior Research Analyst)

Got it. Thank you.

Operator (participant)

Your next question comes from the line of George Sellers with Stephens. Please go ahead.

George Sellers (VP and Equity Research Analyst)

Hey, thanks for taking the question. Maybe sticking with the iDose theme, could you just provide some additional color on maybe where you're seeing early utilization in the first quarter and also quarter to date here in the second quarter? If that's in conjunction with a stenting procedure or another MIGS procedure, and then also what stage of the disease progression these patients who are receiving an iDose are?

Joe Gilliam (President and COO)

Hey, George. It's Joe. I think at this point, when you're early in a product launch like this, you try to keep it as simple as possible. The more variables you introduce, the more challenging it becomes in terms of both education of the sales force as well as for the accounts and the execution on there. And so as you know, and as we've said in the past, the primary goal there is for clean standalone utilization of iDose. Now, having said that, have we seen surgeons for clinical reasons do it either in combination with cataract surgery or in combination with iStent infinite? The answer is yes, we have based upon the clinical needs of those patients. And so we will continue to monitor that and bring it forward.

So I think we're really sticking very close to the playbook that we had prescribed as we drive this forward. And we'll continue to see surgeons expand the use case of iDose as we go forward. Utilization itself and the trends associated with it, very different from account to account. Those accounts who have experience in billing miscellaneous codes, we've seen them really start to utilize iDose more fulsomely. For those with a little less experience, they'll start, they'll try, they'll do a handful, and then wait for the payments to pull through before they greenlight that broader adoption.

George Sellers (VP and Equity Research Analyst)

Okay. That's really helpful color. Then maybe going back to a prior question on this call, how should we think about surgeon training progressing sort of going forward? What's your capacity for number of surgeons you'd be able to train on a quarterly basis, particularly as we think about maybe the fourth quarter and into 2025?

Joe Gilliam (President and COO)

Well, if you look back, as you think about the training from a sales force standpoint and our various products, I think the peak that we achieved was now quite some time ago from a stent standpoint where we were doing 700-800 surgeons a year. I think one of the big differences with iDose is that the majority of the surgeons that we're training have already gone through angle-based surgery. And so from that standpoint, those early cases that are really designed to teach them or reteach them the nuance of angle-based surgery, you have a lot less of that. So I think that we're going to set aggressive targets for the commercial organization to train as many doctors as possible, certainly as we get in the fourth quarter and going into 2025.

We'll dial that in for you all as we get into that phase and we start to really see what the sales force can achieve quarter in and quarter out.

George Sellers (VP and Equity Research Analyst)

Okay. Great. I'll leave it there. Thank you all again for the time.

Joe Gilliam (President and COO)

George.

Operator (participant)

Your next question will come from the line of Allen Gong with JPMorgan. Please go ahead.

Allen Gong (VP)

Thanks for the question. Just one on iDose as well. You talked about how you're working to get coverage from Medicare and commercial plans. A question that I've been getting is just concerns around the copay in areas of Medicare and commercial where the out-of-pocket is not necessarily covered. How do you plan to address that in cases where you can't provide some additional financial cushion, I suppose, and where supplemental insurance isn't as prevalent?

Joe Gilliam (President and COO)

Yeah, Allen. Something that we spend an awful lot of time, obviously, thinking about and assessing and analyzing in detail as a team well before we set the price and certainly launched iDose. I'd break it down this way. Obviously, within the Medicare fee-for-service world, of which a significant, obviously, portion of the relevant lives here exist, the vast, vast majority of those patients actually have some degree of supplemental coverage. It can vary from a lot of different places, whether it's supplemental from Medicaid or whether it's from commercial plans or other supplemental coverage plans that they may have. So for the vast majority of those patients, you'll have really little to no out-of-pocket. The second major bucket you allude to is obviously within the commercial arena.

For that, we'll be approaching that similar to any drug launch or the vast majority of drug launches out there where we will have full copay assistance such that from that standpoint, patient economics will not be an impediment to the utilization of iDose in that payer arena. The last frontier for us and quite frankly, for most procedures and pharmaceuticals today will be Medicare Advantage, where a larger percentage of those patients have a higher out-of-pocket both in terms of the percentage as well as the overall maximum. That's something that is not unique, obviously, iDose or Glaukos in that perspective. There are a decent percentage of those patients who do have no to low copay.

For those who have higher, you tend to see them get treated more in the later part of the year when they may have already exhausted their out-of-pocket maximums earlier in the year with whatever procedures might have arisen over the course of that year.

Operator (participant)

Our next question will come from the line of Joanne Wuensch with Citigroup. Please go ahead.

Joanne Wuensch (Managing Director)

Good evening. Thank you for taking the questions. I have two. The first one has to do with iStent infinite. I mean, that seems to be getting lost a little bit in the iDose focus. How is that doing, and what percentage of the procedures today are in standalone procedures versus concomitant? And then I do have to ask about iDose. And you've been seeing street models and things like that. How are you feeling about a full-year contribution for iDose? And I want to just make sure that expectations are set accordingly. Thank you.

Joe Gilliam (President and COO)

Well, thanks, Joanne. I think first, I appreciate the question on iStent infinite. It does get lost a little bit in the shuffle of iDose. And yet, it's an essential part of what we're doing every day right now in driving what we believe is sort of a shift in the standard of care towards interventional approaches and interventional glaucoma. To the heart of your question, of course, it's a little difficult to quantify with precision. And we don't have enough data to confidently say exactly how that breaks down between standalone and in combination with cataract. But I can confidently say it was a key growth driver in the quarter.

And if you just look at it analytically, the reason why this is the reason why our stent portfolio went from mid-single-digit growth in pretty much every quarter in 2023 to now mid-teens in the first quarter of 2024. What changed there clearly was the fact that we started to establish professional fees, that the APC assignment was reassigned to a level that the facilities aren't losing money anymore. And that really enabled the surgeons to start doing what they would have loved to have been doing all along from a clinical perspective. So it was the key driver, obviously, to the first quarter as we had expected. But quite frankly, it did even better than what we thought going into that first quarter.

As it relates to iDose and the full-year contribution, I don't think we've gotten that granular around how that will play other than to continue to reiterate that right now, we're in that early access phase. We continue to be in that stage for at least the first half. Then as you go into the third quarter and certainly the fourth quarter as the J-code turns on and the J-code plus the ASP reimbursement, we would expect it to become a material driver of our results. When you look at what I said earlier around the seasonality that we expect and the shift towards the second half and the latter part, clearly, the vast, vast majority of that is being driven by iDose and increasing utilization of that as we make our way through the year.

Joanne Wuensch (Managing Director)

Thank you very much.

Operator (participant)

Your next question will come from the line of Margaret Kaczor with William Blair. Please go ahead.

Margaret Kaczor (Medical Technology Analyst)

Hey. Good afternoon, folks. Thanks for taking the questions. I'm going to pile on onto infinite as well because obviously, it's growing at a pretty rapid pace, it seems like anyways. I guess the comps are getting more difficult. I know you're a little maybe not wanting to focus on sequential growth. But I guess from a dollar perspective, can you give us any sense as to whether that infinite number sequentially is accelerating? Is it staying similar, etc.? And then just a sense of penetration rate, either from broader account usage and existing accounts, but no one like infinite versus trying to get into new accounts.

Joe Gilliam (President and COO)

Yeah, Margaret. I think that from a performance standpoint, it's certainly our expectation that iStent infinite would continue to grow sequentially just based upon the organic efforts of our sales force around driving education, awareness, and training of iStent infinite, in particular, in the standalone setting. So I think it's absolutely our expectation that that will continue to be a growing driver of our overall business. To your point, we may have varying degrees in terms of how that translates from a year-over-year growth perspective, just given comparable differences in 2023. But we absolutely expect it to be that. I think in terms of penetration, it's still really early. I mean, you've heard us talk about the standalone opportunity measured in 200,000 procedures for iStent infinite for patients who failed medical and surgical therapy.

And so just in translating even the great results we had in the first quarter, we're still very early in the overall penetration paradigm of iStent infinite and where it can and we expect it to be utilized.

Margaret Kaczor (Medical Technology Analyst)

Okay. And I'll squeeze in kind of the two both on iDose as well as just a follow-up on iStent infinite because I think at our conference even last year, you guys had spoken to just your general enthusiasm that this is going to be a $50 million-$100 million-plus business over time, maybe even faster than iDose can get there. So I don't know if you can speak to your confidence level now that both products have launched around that commentary around timing today versus last summer. And then on the iDose side, I'm not sure if you can give us any color around how the initial surgeons and clinicians are working iDose into their workflow. Are they focusing a day exclusively on iDose? Are these patients that have been waiting for a long time? And how far out are these cases being booked? Thanks, guys.

Joe Gilliam (President and COO)

Well, I think, Margaret, that it's probably—I'm just going to answer the last one first. I think it's probably a little bit premature to make too bold of a statement with respect to how they're working it in, given where we're at in that launch curve. We certainly do have those surgeons who are now working it in fully in the context of how they think about an interventional approach to the treatment of patients. And they all have their own algorithms. But we're certainly seeing iDose in some of these spots become a prominent component of their algorithm. As it relates to iStent infinite on the overall size of market, I don't think anything's changed there. I don't think we've changed our conviction.

In fact, seeing the results that we've seen so far this year, it only probably increases the conviction around the ultimate use case of iStent infinite and that it should be a several hundred million-dollar product from a standalone perspective for us. Again, just going back to the size of the market, you don't have to change the paradigm around an interventionalist approach for iStent infinite to be utilized in those patients who fail medical and surgical therapy. Those surgeons are already there. It's about making sure that they've been trained and they have access and they're appropriately thinking about it in the context of their own algorithms. But we have a lot of confidence in where that's going to head over the course of time.

Operator (participant)

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

David Saxon (Senior Analyst)

Great. Good afternoon. Thanks for taking my questions. A couple on iDose as well. So it sounds like each of the 15 docs did about seven or eight in the first two months that iDose was commercial during the quarter. So how quickly did you see the first cohort do the second and third procedures and so on? Did they wait until they got reimbursed for the first, and then do five or six more? Or was it more even over the two months?

Joe Gilliam (President and COO)

Thanks, David. I think it's a little early to do that. I don't think sometimes, especially in the early days of launch, to do that kind of the math, which I certainly respect around the seven or eight. You just see a wide variation where there are some surgeons who've done more than that, obviously. There are others who have done one or two or three or four and then wait for that reimbursement to come. Again, back to my earlier point, at this stage, it has a lot more to do with their experience with miscellaneous codes, both from a surgeon as well as a staff perspective. Their understanding of how that will play out is driving the early adoption as much as anything else.

I think over time, as that reimbursement confidence is established, you start shifting a lot more to the clinical conversation of when, where, and how they're deploying this. But for right now, it's coming down a lot to their experience within the miscellaneous code and waiting for that payment.

David Saxon (Senior Analyst)

Okay. Got it. And then you've talked in the past about the specialty pharmacy channel. So can you talk here about kind of what the process is to get that established and how long that might take? And then thoughts on how, if at all, that drives adoption further?

Joe Gilliam (President and COO)

Yeah. So the specialty pharmacy channel is not new to us. Obviously, it's an important part of our business on the Photrexa side, one in which we're continuing to optimize each and every day. But it plays a very material role in the, I'll call it, distribution and channel strategy associated with Photrexa. Based upon that, the establishment of that from an iDose perspective is already there. We have all that ready. But you really don't expect to start driving the utilization within that channel until you start to turn on your commercial policies and drive that non, I'll call it, Medicare business where the specialty pharmacy channel is most beneficial. And the second underlying layer of that, obviously, is that you're always then cultivating the relationships as the specialty pharmacy provider with the various payers that are out there.

That process will be ongoing over the course of many years as you try to optimize the coverage within that channel to benefit those commercial patients who will rely upon it. We're ready to go. It's much more about us really unlocking or releasing the commercial side of our iDose business before we start meaningfully making a change on the specialty pharmacy side.

Operator (participant)

Your next question will come from the line of Sam Brodovsky with Truist Securities. Please go ahead.

Sam Brodovsky (VP and Equity Research Analyst)

Hey, guys. Thanks for taking the questions. Just two quick ones on iDose, and then I'll try and sneak in an international one as well. First, just any update or any color you can provide on incremental data on when we may get a replacement label or how those conversations with the FDA are evolving?

Tom Burns (Chairman and CEO)

Yeah. Sam, thanks for the question. Thanks for allowing me to engage after all the questions on iDose commercial. Yeah. As we talked about, we have, I believe, prepared a really compelling proposal to submit to the FDA. We've waited. As you know, there's been a change in the guard at the FDA, and so that dust is still settling. So we will be proposing the movement towards re-administration and really in the coming days. We're hopeful to be able to get a positive response, but we're not counting on it. And I will tell you, as I've said before, one of the things that the investors and analysts should be reassured by is that we have TREX, which we're on track for beginning that clinical trial by the end of the year.

When you do any kind of chronology of when our expectation is to have that commercially available, as we talked about before, best case would be at the end of 2027 into 2028. And so any patient that is undergoing an iStent implantation, typically or invariably by the end of this year or early into 2025, we believe that the TREX will become a compelling offering for re-administration for those patients.

Sam Brodovsky (VP and Equity Research Analyst)

Great. That's helpful. And then also, is there going to be any constraints as you roll out to more doctors? Any constraints we should be considering in terms of how much they can adopt over the coming months before the J-code, whether that be supply or otherwise?

Joe Gilliam (President and COO)

Well, I think that it's at least in the—I think the way you asked that question, in the context of the second quarter ahead of the J-code, I think it's honestly more of the same as we experienced in the second half of February or the second half of the first quarter. You're going to see some who are more confident and will continue to adopt based upon the clinical flow of their practice and obviously focused on the Medicare patient population. And you'll see others who will start and do some trying and ultimately wait for payment to adopt. I don't expect there to be a meaningful inflection in the context of the second quarter as it relates to iDose other than the fact that we'll continue to slowly expand access to those surgeons.

Sam Brodovsky (VP and Equity Research Analyst)

Great. Thanks, guys. I'll leave it there.

Operator (participant)

Your next question will come from the line of Anthony Petrone with Mizuho. Please go ahead.

Dimitri Tahal (Associate)

Hey, guys. This is Dimitri Tahal for Anthony. Congrats again on a great quarter. So I saw on your summary you have had some initial educational meetings with the MACs as part of your efforts to secure professional fee coverage. Can you give us any updates from these talks? Do you have better insight on the timing of when these professional fee coverage will come through? And could they come all at once from the MACs, or it'll be staggered? I'll have a quick follow-up.

Joe Gilliam (President and COO)

Yeah. Yeah, Dimitri. I think this is ordinary course activity. Anytime we launch new products, there's an education process just to make sure those MACs who are open to being educated on a new product like iDose, that they understand what it is and the procedure associated with the drug. And so we've been executing on those as an ordinary course. If you look back at the history of Glaukos as we've launched products, professional fees tend to take somewhere between six to nine months on average to start being at least more consistent in what they're being paid and ultimately then be put on fee schedules. And they rarely happen all at once. They tend to happen on whatever schedule and timeline the MACs themselves individually are on versus it being one fell swoop across multiple MACs at a single point in time.

Dimitri Tahal (Associate)

Okay. Quickly on gross margin, I know you came in a bit lower than expectations. I know that's kind of due to the launch. Do you see it stepping down next quarter, or we see step up next quarter and kind of through the rest of the year?

Alex Thurman (CFO)

Hey, Dimitri. It's Alex. I would say TBD, right? We would just—I'm kind of guiding that you keep in mind a range, maybe between 82 and 84 over the course of the year because of the volatility or potential volatilities to roll out iDose. But again, I'll affirm that we are confident in the accretive nature of iDose to the gross margin over time. And we should start to see that more fulsomely as we exit this year and enter next year.

Operator (participant)

Your next question will come from the line of Steve Lichtman with Oppenheimer & Company. Please go ahead.

Steve Lichtman (Managing Director and Senior Equity Research Analyst)

Thank you. Evening, guys. I wanted to ask about the core U.S. glaucoma business and market. One of the things you had highlighted in your summaries is potential volatility from all of the MAC movement at the latter part of 2023. Are you still seeing some aftershocks from that one way or the other? And also, if you could talk about what your expectations are looking forward, are you hearing anything with regard to what might be next, excuse me, on the MAC front?

Joe Gilliam (President and COO)

Yeah. I think it's been relatively quiet in the context of the impact. There's probably a modest benefit to the stent side of our business as some surgeons or practices have reevaluated the tools that are being deployed and based upon the objective data that's behind those tools. But I think it's a much smaller or negligible impact to the quarter versus as we've spent a lot of time here talking about the growing standalone utilization, for example. As we go forward, it's status quo for now. The MAC next steps and the timing remain unclear. But as we've said before, we do expect to hear from them again. And that stance is really unchanged. And so as always, it's been the case historically.

We'll continue to support the right of the physicians to make clinical decisions on behalf of their patients if and when we see something from these MACs.

Steve Lichtman (Managing Director and Senior Equity Research Analyst)

Got it. Joe, just quickly on OpEx, should we still target about 10% growth year-over-year this year?

Alex Thurman (CFO)

Hey, Steve. It's Alex. I'll take that one. Thanks for the question. The answer is yes. I think the easiest way to think about it is over the next three quarters, you should think of some kind of reasonable sequential increases over time so that you land at the year at about a 10% growth in OpEx compared to the base in 2023, which was $360 million excluding IPR7.

Operator (participant)

Our final question will come from the line of Michael. Our final question will come from the line of Michael Sarcone with Jefferies. Please go ahead.

Michael Sarcone (Analyst)

Good afternoon, and thanks for squeezing me in here. Just another follow-up on iDose. Going back through the first few years of the initial iStent launch, I know you talked about you had a year or two where you did 700 new reps train. You also often talked about, I guess, in 2015, the average rep training three surgeons per quarter. If you think about it kind of along those metrics, do you expect that the average rep today could train more surgeons than that given that a lot of these surgeons are already trained in open-angle procedures, or would it be something less than that because maybe they have more products in the back to sell? Just wanted to get your thoughts on how you're thinking about that metric.

Joe Gilliam (President and COO)

Well, I think you largely framed it the right way. So that's why I'm a little bit hesitant to get too specific on the pace of that training. I'll call it the tailwind from a comparable standpoint is that, as you alluded to, we're not training the majority of these surgeons on angle-based surgeries. So from that standpoint, some of the harder elements of that training, we don't have to spend as much time on. The offset to that is exactly what you said in that we're not just simply launching a single product here in the case of iDose. We have a portfolio. There's a lot of activity around iStent infinite.

And so I think we'll have to feel our way through as the reps start hitting their full stride in terms of iDose trainings and onboarding as we kind of exit this year and go into next year. And we'll provide a little bit more, I think, context to that as we refine our own expectations.

Michael Sarcone (Analyst)

Understood. Thanks. Just one quick one. You talked about you're commencing early initiatives to secure commercial coverage for iDose. If you can give us a download on any types of conversations you're having in these early days with commercial payers and what the feedback and/or receptivity is?

Joe Gilliam (President and COO)

Yeah. Those efforts are really just beginning, but there are a lot of conversations going on. In fact, there's actually a fair number of policies that have already been issued out there. Even though we're not commercially trying to drive that side, coverage has started to turn on in a variety of the commercial payer and other settings around that. I think to date, what you've seen from those policies is exactly what we'd expect. And quite frankly, not all that dissimilar than if you look at the coverage policies that are out there for Durysta today, of which there are plenty. So in terms of the interventional procedural pharmaceutical approaches, I think the payer community thus far has been following the playbook that they established with Durysta as they think about that coverage for iDose TR.

Operator (participant)

I will now turn the call back over to the company for any closing remarks.

Tom Burns (Chairman and CEO)

Okay. I want to thank all of you for your time and attention today and continue to thank you for your continued interest and support in Glaukos. With that, goodbye.