Glaukos Corporation (NYSE:GKOS) has announced a robust start to the year with a 16% increase in first-quarter consolidated net sales, reaching $85.6 million. The company has raised its full-year 2024 net sales guidance to between $357 million and $365 million. The increased sales were primarily driven by its U.S. and international glaucoma franchises, which experienced a 20% growth year-over-year.
The earnings call highlighted the success of the iDose TR microinvasive injectable therapy, the assignment of a unique permanent J-code, and the signing of CPT codes for iDose TR. Glaukos is also advancing its product pipeline, including Epioxa and iLution Travoprost, with new studies expected later in the year.
Key Takeaways
- Glaukos' first-quarter consolidated net sales hit a record $85.6 million, up 16% year-over-year.
- Full-year 2024 net sales guidance increased to $357-365 million.
- U.S. and international glaucoma franchises grew by 20%.
- iDose TR therapy is expected to significantly impact glaucoma management.
- The company is investing in new technologies like Epioxa and iLution Travoprost.
- iDose TR in-office version is anticipated to launch in late 2025.
- Glaukos is experiencing a shift in sales contribution toward the second half of the year.
Company Outlook
- Glaukos expects low to mid-single-digit growth for the Corneal franchise.
- International glaucoma business projected to grow in the low to mid-double-digit range.
- U.S. glaucoma business anticipated to achieve high-teens to 20% growth.
Bearish Highlights
- The strengthening dollar is creating headwinds for international sales.
- Q2 presents a challenging year-over-year comparison due to prior year's launch activities.
Bullish Highlights
- iDose TR and iStent infinite are expected to disrupt typical seasonality, benefiting second half-year sales.
- The company is actively expanding access to iDose and expects to grow the market and potentially take market share.
Misses
- Specific data on the breakdown between standalone and concomitant procedures for iStent infinite was not provided.
Q&A Highlights
- Glaukos plans to address Medicare and commercial co-pay issues to facilitate patient access to iDose.
- iStent infinite is expected to become a substantial product in the standalone setting.
- Discussions with specialty pharmacies for iDose distribution are focused on the commercial side.
- Glaukos is engaging with MAX for professional fee coverage, expecting consistency in six to nine months.
Additional Insights
- The company anticipates a 10% year-over-year growth in operating expenses.
- Training for surgeons on iDose is expected to exceed the initial iStent launch.
- Glaukos is working on securing commercial coverage for iDose, with ongoing payer discussions.
- The company expressed gratitude for the support and interest from call participants.
Glaukos Corporation's first-quarter performance and strategic initiatives indicate a strong position in the ophthalmic medical technology market. The company's focus on expanding access to innovative treatments and securing reimbursement pathways for its products, such as iDose TR and iStent infinite, suggest a commitment to long-term growth and market expansion. As Glaukos continues to invest in its pipeline and advance its strategic plans, the company is poised to transform vision care for patients around the world.
InvestingPro Insights
Glaukos Corporation's (GKOS) first-quarter results paint a picture of a company on the move, with a significant uptick in sales and strategic advancements in its product pipeline. To further understand Glaukos' financial health and market performance, let's consider some key metrics and insights from InvestingPro.
InvestingPro Data reveals a market capitalization of approximately $4.96 billion, reflecting a solid size in the medical technology market. Despite a notable P/E Ratio of -36.56, indicating that the company is not currently profitable, Glaukos has experienced considerable revenue growth in the last twelve months, with a 12.92% increase as of Q1 2024. This growth is consistent with the company's reported sales increase and is a positive sign for investors looking at the company's ability to expand its revenue streams.
The Price / Book ratio stands at a high 11.0, suggesting that the market values the company's assets quite generously, possibly due to its innovative product offerings and potential for future growth. This aligns with the company's focus on expanding access to treatments and securing reimbursement pathways, which may drive long-term value.
One of the InvestingPro Tips that stands out is that Glaukos has a high return over the last year, with a 117.67% price total return. This performance is impressive and indicates strong investor confidence in the company's future. Additionally, Glaukos is trading near its 52-week high, with the price at 95.34% of the peak, which could suggest that investors believe the stock has momentum.
For readers interested in a deeper dive into Glaukos' financials and market performance, InvestingPro offers additional tips. Currently, there are 9 more InvestingPro Tips available, which can provide a more comprehensive analysis of the company's prospects and investment potential. To access these valuable insights, visit https://www.investing.com/pro/GKOS and remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
Full transcript - Glaukos Corp (GKOS) Q1 2024:
Operator: 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 speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] 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: 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 1 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'll 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' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available on 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: 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 to range to $357 million to $365 million versus $350 million to $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 ASUS 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 remains 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 MAX now including CPT code 0671T on the 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 iDose, initial iDose TR procedures during the first quarter and the 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 sales force 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 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 1, 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 has signed 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 1, 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 Max as part of our efforts to secure professional fee coverage and payment over the course of 2024. And fourth, we successfully entered into the Medicaid Drug Rebate Program or MDRP. And 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 of bringing 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 MIGS 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 3 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 2a study for iLution Travoprost with an initial data readout expected later this year. Three, Phase 2 trials for our 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 (NASDAQ:AMD) patients. We also remain on track to commence a Phase 3 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 and 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. So with that, I'll open the call for questions. Operator?
Operator: [Operator Instructions] Our first question will come from the line of Tom Stephan with Stifel.
Tom Stephan: Maybe I'll start on the guide. Can you maybe talk about what the changes are to the constructs 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: 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 some conclusion in terms of 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 stent 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 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 a standpoint gets 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 the 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 place where we our expectations for the Corneal 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 in 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 were we've kept going. And so in the second half of the quarter, we were able to get kicked off with the early access phase of our iDose launch. And as Tom mentioned, really pleased to see our initial 15 surgeons be able to complete their case cases in Q1 in coordination with our sales and training and market access teams. And 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: And 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 TR, which appears might be an in office version of the implant. If you're willing to share, can you elaborate a bit product, maybe the key details, sort of the portfolio fit, I guess, and then any timelines or milestones?
Tom Burns: 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 fast aisle 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 side that's going to be able to be in the range of a 1.2 to 1 millimeter incision, which really gives us then the opportunity to create a cell ceiling construct or a temporal clear corneal incision. And 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 in the timing, we'd be looking forward be probably in late 2025 for a 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.
Operator: Your next question comes from the line of Ryan Zimmerman with BTIG.
Ryan Zimmerman: I want 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 may be 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 that beyond that initial wave of the 15% in the second quarter until kind of that J-code is effective? And are you gating adoption in any way or kind of holding demand before that J-code is effective?
Tom Burns: I think the answer to the number of surgeons who've had access, 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, yes, now that we're sitting here on May 1, of course we continue to expand, we're past that the 15 number from a surgeon training perspective was as of the end of 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've 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 the surgeon maybe they haven'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 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: 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 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? Are you -- 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: So I'll provide a little bit of color. I think we'll help you triangulate in around the breakdown of the results of Q1 for the U.S. glaucoma business. We did see our overall stent portfolio including iStent infinite grow in the mid-teens on a year-over-year basis. So the majority of what you're seeing now obviously we did have iDose TR and some of the early launch activities, but the majority of the growth that you're seeing the tune of mid-teens growth is coming from our stent portfolio. I think it's of course very hard to dissect that down to individual percentage breakdown. 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. And so I think that that is playing out a little bit as we make our way through the year so far.
Operator: Your next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen: So Joe, you raised the guidance at the midpoint by I think the amount of the beat, why not more and the Q2 to 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: Yes, Larry. So I think in the -- I'll try to think of 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 want 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 will 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 dollar. And second, we really more forcibly 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. And if I were trying to put percentages around that I might do something like the following 23%, 24% in Q1, 24% to 25% in Q2 and Q3, and 26% to 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: And 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 1 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?
Joe Gilliam: Yes. 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 with 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 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 Q4 and the ASP is also published. At that point you have a much more cost 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. And we expect that to be pretty important in the unlocking obviously of surgeons really be able to run and do iDose in all the patients that they think are appropriate for the technology.
Operator: Your next question will come from the line of Matt O'Brien with Piper Sandler.
Matt O'Brien: 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 1 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?
Tom Burns: 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 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 implanting surgeons in the first quarter. They had about a half of a quarter to do those 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've done their initial implantations of iDose. And 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: And then the follow-up is just on the profitability side. So I think you said historically, once you guys launch 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?
Alex Thurman: So we'll start with gross margin. Yes, 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 the 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. And then we think about the margin being accretive over time with iDose for sure, and we 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 million if I back out the IP R&D charge of $11.7 million so that was nice. But one thing I'll just say on the expense side is 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 the large PDUFA fee payment that needed to be made. And so that kind of explains a little bit of the slowdown if you're comparing on year-over-year basis.
Operator: Your next question comes from the line of George Sellers with Stephens.
George Sellers: 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: 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 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 thinking 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 to 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 green light that broader adoption.
George Sellers: And 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: Well, if you look back, if you think about the training from a sales force standpoint in our various products, I think the peak that we achieved was now quite some time ago from a standpoint where we were doing 700 to 800 surgeons a year. I think one of the big differences with iDose that the majority of the surgeons that we're training have already gone through angle based surgery. So from that standpoint, those early cases that are really designed to teach them or reteach them the nuance of ankle 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 if we get in the fourth quarter going to 2025. And we'll dial that in for you all as get into that phase and we start to really see what the sales force can achieve quarter in and quarter out.
Operator: Your next question will come from the line of Allen Gong with JPMorgan.
Allen Gong: 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 co-pay 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?
Tom Burns: Yes. 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 break it down this way, obviously within the Medicare fee for service world of which is 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 alluded to is obviously within the commercial arena. And 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 co-pay assistance such that from that standpoint, patient economics will not be an impediment to the utilization of iDose in that payer arena. And 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. And that's something that is not unique to obviously iDose or Glaukos in that perspective. There are a decent percentage of those patients who do have no to low co-pay. And 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: Our next question will come from the line of Joanne Wuensch with Citigroup.
Joanne Wuensch: 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 full year contribution, for iDose? And I want to just make sure that expectations are iDose? And I want to just make sure that expectations are set accordingly.
Tom Burns: I think first, I appreciate the question, I think it's been it does get lost a little bit in the shuffle of items 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 is, 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 Stint portfolio went from 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 it's right now we're in that early access phase, continue to be in that stage for the at least the first half. And as you go into the third quarter and certainly the fourth quarter as the J-code turns on 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.
Operator: Your next question will come from the line of Margaret Kaczor with William Blair.
Margaret Kaczor: I'm going to pile on to infinite as well, because obviously it's growing at a pretty rapid pace, so it seems like anyways. And I guess the comps are getting more difficult. And 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, et cetera? And then just a sense of penetration rate, either from broader account usage and existing accounts, but no one like Internet versus trying to get into new accounts?
Tom Burns: I think that from a performance standpoint, it's certainly our expectation that 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 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 a couple of 100,000 procedures for iStent infinite for patients who fail medical 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: And I'll squeeze in kind of the two both on iDose as well as just a follow-up on Internet. Because I think at our conference even last year, you guys have spoken to like to just your general enthusiasm with us. This is going to be a $50 million plus business over time, maybe even faster than iDose to get there. So I don't know if you can speak 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 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?
Tom Burns: Well, I think, Margaret, it's probably I'm just going to answer the 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 in wholesomely 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 TR in some of these thoughts become a prominent component of their algorithm. And it relates to I said infinite on the overall size of the 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 $100 million 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 failed medical 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: Your next question comes from the line of David Saxon with Needham.
David Saxon: 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?
Tom Burns: I think it's a little early to do that. And 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, and there are others who have done one or two or three or four and then waiting 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. Then 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 right now, it's coming down a lot to their experience with the miscellaneous code and waiting for that payment.
David Saxon: 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 drive adoption further?
Tom Burns: Yes. So especially 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, 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 been cultivating the relationships as a specialty pharmacy provider with the various payers that are out there. So 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. But 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 in the Specialty Pharmacy side.
Operator: Your next question will come from the line of Sam Brodovsky with Truist Securities.
Sam Brodovsky: 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: Thanks for allowing me to engage after all the questions on iDose commercial. Yes, as we talked about, we have, I believe, prepared a really compelling proposal to submit to the FDA. We 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 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. And 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 '27 to '28. 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: 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?
Tom Burns: Well, I think that it's at least in the I think the way you asked that question in the context of the Q2 ahead of the J-code, I think it's honestly more of the same as we experienced in the second half of February. You'll see of 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 folks on Medicare patient population. And you'll see others who will start and do some trying and ultimately 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 solely expand access to those surgeons.
Operator: Your next question will come from the line of Anthony Petrone with Mizuho.
Anthony Petrone: So I saw on your summary, you have had some initial educational meetings with the MAX 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 this professional fee coverage will come through? And could they come all at once from the MAX or be a bit staggered? I'll have a quick follow-up.
Tom Burns: I think this is ordinary course activity as we do anytime we launch new products. There's an education process just to make sure those MAX who are open to being educated on a new product like iDose, 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 MAX themselves individually are on versus it being one fell swoop across multiple MAX at a single point in.
Anthony Petrone: And quickly on gross margin, I know you came in a bit lower than expectations, and I know that's kind of due to the launch. Do you just see that 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: I would say TBD, right, we would just take -- I'm kind of guiding that you keep in mind a range, maybe between 80 to 84 over the course of the year because of the volatility or potential volatilities rollout iDose. And so but we again all affirm that we are confident in the accretive nature of iDose, the gross margin over time and we should start to see that more full suddenly as we exit this year and enter next year.
Operator: Your next question will come from the line of Steve Lichtman with Oppenheimer & Company.
Steve Lichtman: 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 late 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 what might be next, excuse me, on the MAC front?
Tom Burns: Yes. 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 based upon the objective data that's behind those tools. But I think it's a much smaller 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: And Joe just quickly on OpEx, should we still target about 10% growth year-over-year this year?
Alex Thurman: I'll take that one. The answer is, yes. I think the easiest way to think about it is from over the next three quarters, you should think of some kind of reasonable sequential increases over time that you land at the year at about a 10% growth in OpEx compared to the base in 2023, which was 360 excluding IP R&D.
Operator: Our final question will come from the line of Michael Sarcone with Jefferies.
Michael Sarcone: 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?
Tom Burns: Well, I think you largely framed it the right way. And 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 surgery. 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 and 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: And just one quick one. You talked about you're commencing early initiatives to secure commercial coverage for iDose. Do you 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?
Tom Burns: Yes. 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 [Derista], today of which there are plenty. So, in terms of the interventional procedural pharmaceutical approaches, I think the payer committee thus far has been following the playbook that they established with [Derista] as they think about that coverage for iDose TR.
Operator: I will now turn the call back over to the company for any closing remarks.
Tom Burns: I want to thank all of you for your time and attention today and continue to thank you for your continued interest and support of Glaukos. And with that, goodbye.
Operator: That will conclude today's call. Thank you all for joining. You may now disconnect.
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