Glaukos Q2 2025 Earnings Call Transcript

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Provided by Quartr
July 30, 2025

Key Takeaways

  • Positive Sentiment: Glaukos reported record Q2 net sales of $124.1 million, up 30% year-over-year, and raised its full-year 2025 net sales guidance to $480 million–$486 million.
  • Positive Sentiment: iDoseTR sales reached approximately $31 million in Q2, reflecting growing physician adoption and reinforcing its role as a new standalone glaucoma therapy.
  • Negative Sentiment: The U.S. stent business faced MIGS headwinds from five MAC LCDs and the expiration of Hydro MicroStent royalties, pressures expected to continue through 2025.
  • Positive Sentiment: Glaukos secured EU MDR clearance for iStent Infinite with a broad label for all stages of open-angle glaucoma and plans a commercial launch at ESCRS in September.
  • Positive Sentiment: The company completed key milestones in the Epioxxa NDA review, including a successful pre-approval inspection and post-midcycle meeting, with a PDUFA date set for October 20, 2025, and launch planning underway.
AI Generated. May Contain Errors.
Earnings Conference Call
Glaukos Q2 2025
00:00 / 00:00

There are 16 speakers on the call.

Operator

Welcome to Glaukos Corporation's Second Quarter twenty twenty five 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 ww.glaukos.com. After the speakers' remarks, there will be a question and answer session. 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.

Speaker 1

Thank you, and good afternoon. Joining me today are Blaukos' 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.

Speaker 1

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.

Speaker 1

S. And international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, it may cause our actual results to differ materially from those expressed or implied by forward looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors.

Speaker 1

You'll find these documents in the Investor Relations 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' ongoing results of operations, particularly when comparing underlying results from period to period.

Speaker 2

Please refer to the tables on

Speaker 1

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.

Speaker 3

Okay. Thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glaukos reported record second quarter consolidated net sales of $124,100,000 up 30% on a reported basis or 29% on a constant currency basis versus the year ago quarter. As a result of our strong performance, we are raising our full year 2025 net sales guidance range to $480,000,000 to $486,000,000 compared to $475,000,000 to $45,000,000 previously.

Speaker 3

Our second quarter record results reflect a sustained growth acceleration in our business driven by growing iDoseTR adoption and utilization, along with our broader Interventional Glaucoma, or IG, initiatives globally. While we are in the early stages of these IG efforts, our focus remains on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden for the benefit of physicians and patients. We continue to be encouraged with the increasing levels of clinical interest for this paradigm changing evolution. Within our U. S.

Speaker 3

Glaucoma franchise, we delivered record second quarter net sales of $72,300,000 on strong year over year growth of 45%, driven by growing contributions from iDoseTR, which generated sales of approximately $31,000,000 in the second quarter. IDoseTR, a first of its kind intracameral procedural pharmaceutical designed to continuously deliver glaucoma drug therapy for up to three years, continues to build commercial momentum supported by positive clinical outcomes and surgeon feedback that reaffirms our view that with the launch of INOSTR, we are pioneering a brand new therapeutic category that has the potential to reshape glaucoma management as we know it today. Operationally, our teams continue to make great progress in the execution of our detailed launch plans for iDoseTR, including: first, growing the universe of trained surgeons and accounts second, expanding utilization of the installed active surgeon base third, broadening and streamlining market access among max commercial and Medicare Advantage payers fourth, expanding the robust body of clinical evidence and fifth, accelerating marketing investments to support increased patient awareness and education. Shifting to our U. S.

Speaker 3

Stent business. As anticipated, the five MAC LCDs implemented in the 2024 continued to cause some transient turbulence in the market during the second quarter as surgeons navigate restrictions when using two MIGS surgical devices in the same procedures. We expect this MAGS market headwind will continue over the course of 2025 as providers continue to navigate the impacts associated with these LCDs until it anniversaries later this year. As a reminder, our second quarter U. Glaucoma results also reflect the expiration of royalty payments associated with the Hydro MicroStent, which concluded in late April.

Speaker 3

Earlier this month, CMS issued its proposed rules for 2026, which as drafted, largely maintained the 2025 APC assignments and modestly increased facility fee rates associated with our procedures across both the hospital outpatient and ASC settings. In contrast, CMS has proposed reductions in physician fee reimbursement for several category one CPT codes across ophthalmology, including for cataract and surgical MIGS procedures specifically, along with several other specialties. These stem primarily from a major revision in how CMS allocates indirect practice expenses within its RVU methodology, particularly impacting services performed in the facility outpatient setting. We intend to support our customers and societies as they educate CMS on the proper assumptions associated with this proposed methodology shift. Beyond that, we believe these proposed changes further support a more diversified practice mix that includes interventional glaucoma treatment and underscores the value of our standalone therapies such as iDoseTR and iStent Infinite, which, as procedures covered by category three codes, are currently unaffected by this proposed physician fee rule.

Speaker 3

Moving on. Our international glaucoma franchise also delivered record net sales of $31,300,000 on year over year growth of 20% on a reported basis and 15% 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 banks forward as a standard of care in each region and major market in the world. Last month, we were pleased to announce EU MDR clearance for iStent Infinite along with several of our other leading trabecular micro bypass, MIGS, technologies. Of note, this clearance provides a broad label for iStent infinite indicated for patients with all stages of open angle glaucoma in both combo cataract and stand alone procedures.

Speaker 3

These important milestones, which company's long awaited first approvals under the new EU regulatory framework, will not only help us maintain and grow our presence in Europe, but also advance and accelerate our broader IG initiatives globally. We plan to commence commercial launch activities for iStent Infinite in our key European markets at the upcoming ESCRS Annual Meeting in September. As previously discussed, we continue to expect the trialing of new competitive products in some of our major international markets may become an increasing headwind as we progress through 2025. And finally, our corneal health franchise delivered net sales of $20,600,000 on a year on year growth of 4%, including Photrexa net sales of $17,900,000 As discussed previously, our second quarter results reflect the continued impact of Photrexa realized revenues as a result of our entry as a company into the Medicaid drug rebate program for NDRP. Shifting gears to our corneal health pipeline and FDA's ongoing NDA review for Epioxa, our next generation corneal cross linking eye link therapy for the treatment of keratoconus, a rarely diagnosed site threatening disease.

Speaker 3

During the second quarter, we completed several important review related milestones, including a successful pre approval inspection, or BAI, at our Burlington, Massachusetts facility, along with a productive post mid cycle review meeting with the agency as we continue to progress towards the established PDUFA date of 10/20/2025. Alongside this regulatory review, our commercial and market access teams continue to make solid progress in the preparation and planning of the Epioxid commercial launch targeted for next year. As a reminder, this potential approval will provide Keratoconus patients in the ophthalmic community with the first FDA approved, surgery free topical drug therapy that's catalyzed by pulsed oxygen and light that does not require removal of the corneal epithelium, the outermost layer of the front of the eye. An Epioxid approval would also provide us with opportunity to launch this pharmaceutical therapy supported by the right long term pillars to optimize patient access, a persistent and at times frustrating challenge for us historically with Vetrexa. Because we believe Epioxa, which is designed to preserve the corneal epithelium, streamline the procedure, improve patient comfort, and shorten recovery time, represents a potentially breakthrough treatment advantage and advancement for keratoconus patients.

Speaker 3

We anticipate some potential transient disruption with our U. S. Corneal health franchise as the market transitions from Photrexa to Epioxxa following targeted approval, which is reflected in our latest full year guidance outlook. Beyond Epioxa, we continue to advance several other important clinical programs across our five novel therapeutic platforms. Within our iStent surgical glaucoma platform, we are advancing patient enrollment in a PMA pivotal trial for iStent infinite in mild to moderate glaucoma patients, as well as a five ten pivotal trial for the Presser Flow MicroShunt.

Speaker 3

Within our iDose platform, we are advancing a Phase IIbIII clinical program for iDose T Rex, our next generation iDose therapy with patient enrollment already underway and now expect an FDA decision regarding readministration for iDose TR in early twenty twenty six. Within our iLink platform, in addition to the ongoing Epioxxa NDA review, we are also advancing Phase II trials for our third generation isling therapy. Within our ILUTION platform, we remain on track to file a U. S. FDA IND and commence a clinical trial for ILUTION Demodex blepharitis later this year.

Speaker 3

And finally, within our retinal platform, we are advancing a first in human clinical development program for GLO-four zero one, our intravitreal multi kinase inhibitor retinal program in wet AMD patients, where we now also have an open U. S. FDA IND. So as you can see, we have a lot to be excited about when it comes to significant potential value that we believe our pipeline programs may create. At the same time, as we consistently discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk based spending while maintaining our strong capital position both now and in the future.

Speaker 3

This disciplined approach has enabled us to stay active on the business development front with a focus on transactions that complement and enhance our existing organic growth initiatives. During the second quarter, we put the strategy to work with the small acquisition of Movius Therapeutics, whose lead compound Midasol is the only FDA approved ophthalmic formulation of mitomycin C or MMC, which is often utilized as an adjunct in late stage glaucoma filtration procedures. This addition helps to solidify our supply chain as it's being utilized alongside the Presser Flow MicroShunt in our active 05/10 study. It will also support our broader late stage glaucoma tertiary care efforts over time and further add to our deepening relationship within the glaucoma specialist community. We also continue to invest operationally to support our long term growth plans with the purchase of an additional building at our Aliso Viejo headquarter campus during the second quarter.

Speaker 3

Excluding these two onetime investments, our underlying cash and equivalents grew by more than $4,000,000 in the second quarter. So in conclusion, I'm very pleased with another record quarter and sustained strong momentum in our business as we continue to successfully advance our mission to truly transform vision by pioneering novel dropless platforms that can meaningfully advance standard of care and improve outcomes for patients suffering from site threatening chronic eye diseases. Our foundation is strong, and we are ideally positioned to continue transforming vision for the benefit of patients worldwide. So with that, I'll open the call for questions. Operator?

Operator

Your first question comes from Tom Steffen with Stifel. Please go ahead.

Speaker 4

Great. Hey guys, thanks for taking the questions. Nice quarter. One sort of near term just on 2025 sales guidance. You beat Street in 2Q on revs by, I think, 8,000,000, 9,000,000.

Speaker 4

But on the guide, you only raised by $3,000,000 at the midpoint. Tom, you made some comments on OUS glaucoma and corneal health within the guide. But Tom or Joe, can you talk about the components of this year's revenue guide? And then maybe why more of the upside wasn't flushed through for the full year?

Speaker 5

Yes, Tom. It's Joe. And, if Tom wants to add something at the end, he can. Obviously, you did the math pretty quickly there. The the fact is we're we're pleased to be able to be in a position to raise guidance off the back of what was an exceptional second quarter as as you noted, and that was really driven by outperformance across the board, but largely by items, in particular.

Speaker 5

And I think when you, parse back some of the commentary from Tom, and I'll elaborate a bit more, you'll find that that really it was a full beaten raise in the context of Aidos, which is at the up to the core of of the growth story as we sit here today. But but several data points as you think about updating your models for the second half of the year. You know, first, on the international glaucoma side, obviously, we continue to be off a strong start this year. It it had some currency, you know, benefit in the second quarter, and we're now expecting that you'll have sort of low double digit growth for the remainder of the second half on a year over year basis. So largely unchanged there in terms of our expectations of our growing scale and competitive products launching in key markets that present headwinds as we move forward relative to obviously the strong first half results.

Speaker 5

On the cornea side, Tom, I think, elaborated on this, but I'll repeat it. When we go into the second half here, we enter a period with, I'll call it, less visibility or predictability as we navigate the transition from postrexa to Evioxa, assuming the latter is approved as expected in October. So our current expectations are for flat to low single digit growth, if you will, in Q3, followed by a material disruption headwind in Q4 as patients forego Photrexa in favor of Epioxus for all the reasons that Tom articulated. And that leads you obviously on The US glaucoma side where, you know, we continue to expect the same dynamics around the LCD headwinds and the hydrous, royalty expiration and then the generation of probably a mid single digit decline for, I'll call it, the non iDOS revenues in the second half. And when you put all that together, it's gonna imply continued sequential iDOS expansion in q three and q four and an overall expansion of our expectations for the full year on the iDose front.

Speaker 4

That's great. Appreciate that. Then pivoting a bit more kind of big picture just on interventional glaucoma, approaching eighteen months into the iDose launch. So kind of just wanted to ask about the state of the union with interventional glaucoma. What are the learnings, the puts and takes around those broader IG efforts?

Speaker 4

And Joe or Tom, where does the bullishness your bullishness stand kind of in terms of the long term opportunity with IG?

Speaker 5

Well, I can start off here. I'm sure Tom will have some views as well. Obviously, if you think about this being part of the kind of the birthright of us as a company over the years. But I'll start, Tom, by acknowledging some of the foundational work that that you recently did on this paradigm shift, and and I'm glad you asked the question. I I think it was a good state of the state snapshot, but also a bit of a indicator of how far we've come over these last eighteen to twenty four months in terms of building the stand alone market opportunity.

Speaker 5

Yeah. Hopefully, you all have visibility and awareness of just how pronounced the shift in momentum, towards interventional approach into glaucoma care has has changed as we began our efforts in support of it, you know, a year and a half ago. The the underlying movement, if you will, largely led by Glaukos in partnership with physicians to be proactive on behalf of patients now that tools like iDoseTR and iStent infinite really enable a a risk benefit equation that makes sense is is rapidly gaining gaining traction. And it it's worth reminding investors what this means for, I'll call it, the next decade in ophthalmology. Has the twelve to thirteen million diagnosed and treated glaucoma eyes in The US also increasingly seek an interventional approach to care.

Speaker 5

I mean, you compare that to cataract surgery, which is the mainstay of our industry today, that does about 5,000,000 procedures annually, it it's hard not to see how bright the future is for for Glaukos and and our industry overall as we improve the standard of care for patients. And I have to give credit to our our marketing team, our our sales team, and the numerous other folks here at Glaukos that are that are driving this rapid change from both the top down and the ground up every day has got us here.

Speaker 4

That's great. Thank you.

Operator

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

Speaker 6

Thanks for taking the questions. Congrats on the quarter. And appreciate you giving us the iDose number and removing the guesswork on that one. Maybe just to start off with iDose for a second. You've made progress on certain MACs and others are still not fully there, I guess, is the best way to put it.

Speaker 6

Can you compare and contrast kind of the geographies in which MACs are fully covering iDose without any disruption or any slowness? And how is the utilization amongst that physician base compared to, say, a territory or a state that's in a MAC that may not, you know, be fully there and and kind of your timelines and assumptions for when those ramp, Joe?

Speaker 5

Yeah. Happy to touch on that, Brian. And and as you, commented, we we did disclose the 31,000,000 approximate sales of of iDose in the second quarter, which was a a significant step in the the right direction. And and the performance really was driven by a mix, and a continued mix of both new starts and increasing utilization within those accounts who who've been at it for for a bit now. And and really to kinda dive in, I think, in the heart of some of your question, while we saw growth nationwide in pretty much every geography, the acceleration continue to be faster in those MAC regions where the professional fee had been established for a bit.

Speaker 5

And that's really driven again by widening surgeon adoption over the course of 2025 that began to translate into procedures given the typical scheduling backlog you see in ophthalmology, and I know you know well. And to put that into context, NovaSTOPs, the radiator first coast, which, are the the max who've had a professional fee schedule, in place for a little bit. You know, they represent a little over 50% of Medicare lots, those regions. But we saw over 80% of our items volumes come from those areas in q two, and that's a growing percentage of the overall mix. And so that I think that's a trend that goes well for our business as these other MACs finalize their their iDOS and professional fees schedules here in the, hopefully, relatively near future.

Speaker 5

The second part of your question was kind of, you know, where do we go from here is the way I would I would summarize it. And and I I would just say that, you know, all the Macs now appear to largely be paying the J code properly, which is the the first step in the journey, if you will, and and continued progress that we've seen there. And as it relates to professional fee beyond Meridian, Novitas, and First Coast, we we believe that that NGS has made considerable progress. We're seeing increasing momentum that makes us hopeful that in the relatively, near term, we'll see a professional fee get established in what is the third largest, map region, in The United States. We continue to make slow and, I'll call it, methodical progress with Palmetto and WPS.

Speaker 5

We've really accelerated our advocacy and education efforts, both at the account level but also with the maps themselves. And we started to see the earliest signs of positive pro fee payment flow, but but there's still work to do in in both of those important MACs. And then, really, CGS, I would say, remains behind the others by a fairly considerable margin at this stage, and and we are engaging directly, with them and have them for some time. And and, eventually, it's the smallest smack of all. We we do expect them obviously to come around, alongside the other other maps.

Speaker 6

Very helpful, Joe. And and just sticking on the topic of professional fees for a moment and and turning to the legacy mix business. So, you know, we all saw the proposals. You know, I remember many years ago, doctors were making, I think, close to a thousand dollars to implant a mix. We're now pushing around $100 maybe sub-one $100 We'll see kind of where the proposals land.

Speaker 6

I guess my question is more of a bigger picture question, though, on that topic, which is as the pro fees have come down, how do you think about legacy surgical glaucoma and the broader appeal to say non glaucoma ophthalmologist? The comprehensive ophthalmologist who maybe was your marginal customer who was doing mix, as that comes down, does that get offloaded to the glaucoma specialist? I'm just curious kinda how you're thinking about maybe some of those economic incentives.

Speaker 5

Yeah. I I think, Ryan so, there's a couple things to unpack in in in your statement. The first one is in a large to a large extent, professional fees are about relativity in the context of the economics for that surgeon's time, whether that be in the context of cataract surgery, mixed procedures, stand alone procedures, or or the like. And and as you heard Tom say and we know from the proposed rule, what you've seen across many, therapeutic categories, not just ophthalmology, but many others, and then certainly across the board in ophthalmology, is the wholesale shift in the way CMS is is calculating, the professional fee economics and the RVUs that that that drive them. And so I think there's an education process that has to happen led by the societies and the the various groups that that have a voice with with CMS to help make sure that lands in the right the right spot.

Speaker 5

But where I where we land on it, I think, was was articulated by by Tom in the prepared remarks. The the the reality of what we're seeing unfold only, emboldens the move towards stand alone glaucoma therapy as a a a pathway for the average practice to continue to remain financially viable as they move forward here and face that. I mean, to put that historical statement in context, there was a point where cataract surgery and pro fees were over $2,000 a procedure. And today, obviously, in the proposed rule, they're in the 4 hundreds. So you know?

Speaker 5

And and, obviously, doctors continue to do, cataract surgery as the ubiquitous standard of care for for that disease indication. I think what you're gonna see is more and more of those broader ophthalmologists leaning in to what we've been talking about, which is interventional glaucoma, you know, paradigm shift and starting to really treat these patients proactively as a part of both doing the right thing for the patient and the right thing for the practice.

Speaker 3

Well, I agree as well. And Ryan, this is Tom. If you look at the recurring changes and reductions in fees that are happening as we've now seen over the last several years in cataract surgery, and we believe that's going to continue going forward. And I think not only do we have the immunization here on the current CMS provisions of category three codes of really high paying standalone payments for iDose and iStent infinite. But I think as we go forward, these comprehensive ophthalmologists who right now are spending most of their time recruiting cataract patients for one and done procedures, this is catch and release, are going to start waking up to the value of looking at glaucoma as a long term treatment pattern and what we're calling the forever patient.

Speaker 3

And with the forever patient now, with a statutory time of twenty plus years from the time of diagnosis to life termination, there'll be multiple opportunities for these surgeons to reenter and to reimplant with procedural pharmaceuticals and with stents. And I think that will start to really resonate with these comprehensive ophthalmologists, not only as a more advanced standard of care for patients to stop the progression of glaucoma, but as an offset to the chewing that's happening on the professional fee side for their cataract surgery procedures.

Speaker 6

Yeah. Thank you for that complete answer there. Thank you.

Speaker 3

Welcome, Sven.

Operator

Your next question comes from Alan Gong with JPMorgan. Please go ahead.

Speaker 7

Hi. This is actually Rohan on for Alan. Thanks for taking the question. I just wanted to ask about the ramifications of the proposed reimbursement to start off, just the higher facility fee offsetting the lower physician fees. How are you thinking about that and the impact for that next year?

Speaker 8

And do you view it as more of

Speaker 7

a rising tide that lifts all MIGS boats? Or I just want to get a sense for how you're thinking about it.

Speaker 5

Yeah. I think, Rin, you're talking about the proposed rule around the facility payments. And obviously, we are pleased to see those step up largely in line with the pace of inflation. So I think in general, that's a positive across the board for those folks who own and operate facilities and the manufacturers that provide tools and technologies and therapeutics into those facilities. I'm not sure I would call it out as a particular driver.

Speaker 5

If you think about the setup for 2026, it's more of a neutral but slightly positive event in the context of Glaukos and I think the other participants in the MIGS field.

Speaker 7

Thanks. And just a quick follow-up as well on SG and A. There was a fairly big step up in the quarter. Just want to get a sense for what's driving that relative to expectations? How are you thinking about SG and A growth for 2026?

Speaker 7

Is that 10% level still a good way to think about it, or should we expect something a bit higher?

Speaker 2

Hey, Rohan. This is Alex. Thanks for the question. And it is a great question. So you're right.

Speaker 2

There was a little bit of a step up in both SG and A and total OpEx year over year and and during the quarter. We wanna point out that within that number I'm gonna speak to the total OpEx as a as a predicate. So within the within the total OpEx number, there's about a $4,000,000 onetime stock comp expense hit, that occurred based on the triggering of certain, performance awards that happened during the quarter. So if you exclude that and you look at that as on an adjusted basis, the OpEx would have grown around 16%. And as we've guiding guided in the in the past, you know, we've always kinda said our OpEx this year would grow in kinda the mid teens.

Speaker 2

So that's kind of in line with what we spot what what what we would have expected, excluding that stock comp expense. And then if you think about it on a go forward basis, again, speaking as a total OpEx, we would expect that third quarter to be roughly flat to our reported second quarter number. And then the fourth quarter maybe a sequential step up from there. When you put all that together, you're looking at something for the full year in kind of the $460,000,000 range, which is more the top end of the range that we were thinking about previously. And that, again, translates to about mid teens growth year over year.

Speaker 7

Thank you.

Operator

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

Speaker 9

Hi. This is Simran on for Larry. Thanks for taking the questions here. Just one on guidance. Any finer point on the cadence of, sales in the back half?

Speaker 9

You know, as I think about the color that you've provided around, items and the different, you know, reimbursement updates with regards to the max. You know, should we be thinking about sort of an incremental step up in q three and, you know, something that's a little bit more q four weighted? And just sort of what would that exit rate imply for, you know, iDOS beyond this year?

Speaker 5

Yeah. Hi, Simran. It's Joe. Yeah. I I probably given sufficient color in the context of the second half in totality.

Speaker 5

Maybe the best way to to answer the question around the the, I'll call it, the cadence from q three to q four is to dial in a bit on what you typically see in Q3. And as you know, in ophthalmology, certainly in our business, Q3 tends to be a seasonally down quarter just given summer holidays on a global basis. If I put a finer point on that in the context of our various franchises, the corneal health business tends to be kind of flat to up a touch. But I think with lower device sales and some potential EpiOxa, obviously, related noise as anticipation grows for that product, approval, the way to probably think about that is is sequentially being a bit flat to what we saw in in q two out of the cornea business. International glaucoma usually takes a couple million dollar step down in q three, relative to q two.

Speaker 5

And then as it plays to The US glaucoma business, the non IDOS related portion typically also takes a step down of a couple million dollars from Q2 to Q3. But we would expect, obviously, some iDOS offset there to put you back into kind of positive territory Q3 versus Q2 on The U. S. Glaucoma. You put all that together, I think where your model will land is sequentially down a bit relative to Q2.

Speaker 5

And then as often is the case in ophthalmology, Q4 obviously becomes the important more important of the two as we exit the year and a lot of procedures get done.

Speaker 9

Okay. Great. That's very helpful. And just for my follow-up, so we do continue to hear from physicians and our surveys that a high percentage of iDose cases are done in combo cataract. Can you share a national percentage with us?

Speaker 9

And how is that trending versus your expectations?

Speaker 5

Yeah. I I think there there can be some noise in your sampling there, obviously, and it's not something that that we track, closely nor are we, able to. As you know, when when a a facility orders iDose, at the end of that, there's no direct relationship to knowing whether or not they've done it in combination with cataract surgery or not. But having said that, we believe that the largest utilization continues to be in standalone procedures. And as reimbursement gets solidified, surgeons naturally start to look at it in both settings, where meeting the patient where where where they're at.

Speaker 5

If they've got elevated pressure and they're looking to control that, whether that patient has, you know, comorbidity with cataract or not, they're increasingly turning to to iDose. So we would expect, certainly over the intermediate period, a little higher percentage being done in combination with cataract surgery, let's say, the beginning or certainly as we think about it over the next three, five and ten year period. But I wouldn't say that it's the dominant portion of what we're seeing today.

Operator

Great. Thank you. Your next question comes from David Saxon with Needham. Please go ahead.

Speaker 10

Great. Thanks for taking my questions. Congrats on the quarter. A couple for me, one on iDose and then I'll have one on Criminal Health. So first for iDose, specifically for the reimbursement, you think we'll be at a place exiting the year where maybe six or all seven of the max are paying out the J code with an established pro fee?

Speaker 10

And is there anything that needs to be done outside of just getting cases submitted for the four that are lagging to kind of catch up?

Speaker 5

Yes, David. So just I think, first of all, on the J code itself, we're already largely seeing all of the MACs increasingly paying those as they should. As it relates to professional fee, which I think is the heart of your your question, it is, in large part, a volume game, because what the MACs do is educate themselves on the procedure, the cost and resource utilization associated with that. And as they get more data points, they're able then to arrive at the appropriate crosswalk and pricing of of that, category three code, and that's when they'll publish it. I I think we you know, as as I noted earlier in the call, we've made an awful lot of progress with virtually all the MAX probably with the the loan exception being CTS.

Speaker 5

And so as I think about going forward, I certainly hope that that would be the case. I can only say that we'll be doing everything possible from an advocacy and education and driving those required volumes to get the MAX to a place where they feel comfortable pricing it in a manner similar to what we've seen obviously already out of Noridian, Novitas and First Coast.

Speaker 10

Okay. Great. And then on corneal health, so after Epioxxa is approved, how are you thinking about rolling out the Epioxxa cross linking machine? My understanding is that it's gonna be a different machine. So is that a trade in?

Speaker 10

Is it a new purchase? And then over what period of time would you expect installed base to convert over to the new machine?

Speaker 5

Yeah. It's a good question, David. I'm not going to get too deep into the particulars. Obviously, certainly, in advance of an approval in hand, I think when we get to that point, we'll give a lot more context. But you raised one of many pertinent points around what will be the rollout and transition period from Votrexa as the standard of care today and what we expect with Epioxa.

Speaker 5

And as you heard Tom mention in the prepared remarks, we do expect an impact from those that transition over the course of certainly the fourth quarter and into early next year, part of which is driven by what you're describing around getting the new systems installed and out there. But, really, the biggest driver of this is gonna be simply the fact that most patients who are educated on the relative differences of the noninvasive, you know, procedure alternative that exists with Epioxa are going to want to defer to the extent they can to get access to what is a superior procedure from a patient perspective. And so we do expect there to be a bit of that, I'll call it, warehousing of patients post approval until we're really fully up and running, both from a site of care perspective with the machines that you're describing as well as a patient access perspective from a reimbursement standpoint.

Operator

Your next question comes from the line of Joanne Wuensch with Citi. Please go ahead.

Speaker 11

Good evening and thank you for taking the question. I'm catching up here a little bit with others reporting, so forgive me. But did you comment on the full year guidance for IDEF based on what you are seeing in the market at this stage? And then my second question, as we think start to think about the EVRIOXA approval, how do you start to think about when that revenue may begin to ramp? And to your point, if patients are putting the procedure off until it is available, is there a wait list at starting?

Speaker 11

Or is that too early?

Speaker 5

So, hi, Joanne. First, on the iDose guide, a bit of a repeat, and you'll be able to see it in, I think, the remarks that become available. But really, the punch line on iDose is as you weave your way through the second half across the various franchises is that there's an implied obviously, it was predominant part of the beat in the second quarter. And really on the heels of that, we've effectively raised our guidance for the full year around iDose, and we continue to see that growing momentum that you'd hope for around the utilization of that, in particular, in those regions that where the professional fee has been established in Novitas and already in the First Coast. As it relates to the EpiOXA approval, I think from a big picture standpoint, there's a series of things that that have to take place to where you're really running with any new drug, certainly in a in a, you know, rare disease category like keratoconus.

Speaker 5

And, you know, as we make our way through 2026, we expect to to to methodically unlock some of those. An important moment along that journey is to establish of a J code, which we would expect in midyear. But even through the course of the year, you're educating, in this case, commercial payers. You're updating policies. You're doing all the blocking and tackling to to get access for patients to a therapy that clearly they're gonna want, over, the the prior standard of care in in the form of Photrexa.

Speaker 5

And the last thing I think you you referenced, no. There there wouldn't be any formal wait list at this point. You don't have an approved product. And so those conversations aren't really happening, certainly not on behalf of of Glaukos or our organization in any way, shape, or form. It's possible that some surgeons have just simply because of the public nature of of the trial or their involvement in it, would be having some conversations with with patients.

Speaker 5

But I'd say that's probably on the on the margin at this point. It is something we expect to be an important dynamic that will play out post approval. So as you make your way through into, call it, November and December in the fourth quarter, you can expect that an increasing percentage of those patients will be having exactly that conversation with their physician. And we expect a significant portion of who can't will try to defer and get access to Epioxid just simply given the pain and the recovery time associated with Photrexa versus Epioxid.

Speaker 11

Thank you.

Operator

Your next question comes from Adam Mader with Piper Sandler. Please go ahead.

Speaker 12

Good afternoon. Thank you for taking the questions and congrats on the quarter. Two for me, both on iDose and I'll ask them upfront. So first on the reimplantation decision from FDA, if I heard in the prepared remarks correctly, it's early twenty twenty six. I thought before it was potentially before year end.

Speaker 12

So did we have a little bit of a wiggle there? And if so, why the change in timing? And then secondly, for eidos Trio and the in office opportunity, can you just put a finer point on time lines there and kind of what needs to be done to unlock the office opportunity for eidos? Thanks for taking the questions.

Speaker 3

Adam, this is Tom. I'll be happy to take both those questions. So first of all, on the FDA's position with regards to iDose reimplantation, I guess the wiggle, as you'd call it there, was the FDA recently classified our petition as an NDA supplement. And so with that, gave us a PDUFA date, which followed the statutory guidelines that they've set, is now 01/28/2026, which gives us certainty now for understanding what the position will be. And so while we believe we've made a a compelling case for reimplantation, as I've said in the past, I just want to to alert the investment community that we are not at all counting on a positive outcome.

Speaker 3

It would be a a very a very forward website if we were able to have a positive outcome on the high dose reimplantation discussions. Secondly, with regards to Trio, I think first it's important to note that we've already demonstrated that in our patient subset of a phase three clinical trial, we stratified and we did a number of patients in office using the current iDose applicator and iDose device in an office setting. Those data we are now stratifying and we're pulling together for a submission for a peer reviewed publication as we speak, and we think they will replicate the safety and efficacy of eye dose implantations that are done in the ASC. We are currently in the process of initiating discussions with Max, as I've talked about before, with the intention of creating a nonfacility payment code, which will allow for the reimbursement of iDose implantation in office setting. And as I've stated previously, this will likely be a several months long process.

Speaker 3

With regards to iDose Trio itself, we've gone through several enhancements of the improved iDose applicator. We continue to optimize the final engineering design. And as I've said before, we're designing this new approach with the existing iDose device. The applicator will target an approximately one millimeter incision. And by doing so, it should allow us to perform a closed chamber procedure which can maintain chamber pressure and minimize dehiscence of aqueous humor, and that's aqueous humor that would kind of percolate out during the procedure.

Speaker 3

We have a final design which is now targeted to enter a U. S. Clinical trial by year end. And while the design itself and the clinical trial is relatively short, the FDA has asked us to perform some additional testing over the period of one year. We'll now be targeting the approval of the high dose Trio by year end 2027.

Speaker 3

Let me just say this new product may aid in the transition for surgeons to in office surgery, particularly as we establish nonfacility payment codes at each of the individual MACs. It is the first of what I anticipate will be many development efforts that we'll be making to optimize in office implantation of iDose. And I think the development of this product as well as our subsequent products comes at an enviable time. As we think about the recurrent reduction of cataract surgical fees, the future capacity constraints of ASCs, and accelerating the demographic patient demands of IG procedures are going to continually drive surgeons to perform in office implantation. So back to Tom's initial question, where are we going?

Speaker 3

We have incredible standalone opportunity in front of us. We are driving and creating a new marketplace just like we've done previously, creating a global MIGS marketplace. We intend to do so as we go forward in the future. It will be led, spearheaded by procedural pharmaceuticals and by our stent combinations. And I would say as well, as you think about where this could go, I do believe that people will look for multiple mechanisms with single implantations.

Speaker 3

So we'll see surgeons, as they already are in the real world, starting to put in iDose with the iStent Infinite or even a competitive product to be able to reduce pressure, target pressures, where they can arrest the progression of glaucoma. So I think we have an incredible opportunity in front of us. The office implantation over the next five to ten years will be an accelerant to get to the surgeons and patients to where I think they deserve to go.

Speaker 7

That's great color. Thanks, Tom.

Operator

Welcome. Your next question comes from Richard Newitter with Truist Securities. Please go ahead.

Speaker 8

Hi. Excuse me. Thank you for taking the question. Just the first one, I was wondering if you could characterize, the the the utilization trends or really any anything any kind of behavior you're noticing in in situations where the Propriet is established by size by max and and and without. And if you could specifically talk that everything from, you know, doc training, if if you're noticing more docs, getting trained or accelerating doc training in in those situations or regions to, whether or not you're seeing combo cataract use potentially differ in, you know, propy on or propy established situations.

Speaker 8

And then if you could also characterize the utilization differences between the national average and any any regions where you

Speaker 5

have a growth theme. Thank you. Yeah, Richard. And and and some of this will be, you know, a bit of a rehash from earlier in the call, but I'm I'm I'm happy to do it as you think about what's going on. I I think the most important overall statement, and it's evidence of giving many of the answers that you to the questions you asked, is the continued acceleration in Novitas, Meridian, and First Coast that is exceeding that of the overall country.

Speaker 5

So when you think about the performance that we just had in the second quarter and the fact that 50% of the Medicare lives are represented in those three max where you have an established professional fee. We saw over 80% of our IDOS volumes come from those areas in q two, and that's a percentage that's actually been increasing in in recent quarters. The momentum there is driven by virtually everything that you you just asked. So we see a faster pace of doctor, you know, training and and and onboarding. We see, you know, overall increased utilization, at an increasing number of accounts where they move past trying and trialing, and they start going into the full adoption mode, at least within the Medicare fee for service arena.

Speaker 5

And we also see, a widening of of how they utilize it. You know, in the early days, to to minimize both, clinical distraction as well as reimbursement distraction, you know, we really mandate that they they do these in the stand alone procedures. And as they get their sea legs, on both of those fronts, you see them start to expand, into not just stand alone procedures, but also utilizing it in combination with cataract surgery really based upon the need for treating the glaucoma, irrespective of whether that patient has a cataract or not. So I would tell you that, in in virtually every, you know, KPI or metric you might look at, those regions that are are are contained within, Novitas, Noridian, or First Coast, you're seeing outperformance relative to the other, areas of the country.

Speaker 8

And just a quick follow-up. Thanks for the sequential color, 2Q to 3Q and then 3Q to 4Q. I just wanted to clarify, did you say that U. S. Glaucoma would be up quarter over quarter, two two to three two, where iDose is obviously up sequentially and and core core or non iDose is down and that that's out to positive?

Speaker 8

Or just just what's the what's the directional trend on US glaucoma quarter quarter over quarter?

Speaker 5

Yeah. I can confirm that. I I obviously, volumes in the third quarter are down. Right? I mean, physicians are on vacation.

Speaker 5

There's a lot less activity in the third quarter than in the second, and that's generally always been the case, at least certainly over over recent years. And and we do and what we've seen in in prior years is that nonidose business, if you will, down a couple million dollars, which, we would expect to get, IDOS offset. And I I think that should put us back into the positive category on a sequential basis for The US glaucoma franchise. Thank you.

Operator

Your next question comes from Michael Sercon with Jefferies. Please go ahead.

Speaker 13

Good afternoon and thanks for taking the question. Just had a follow-up on The U. S. IStent business. Looks like it might have declined about 10% in the second quarter.

Speaker 13

And Joe, I think in your walk through for 2H, you mentioned maybe mid single digit declines. And I don't know if I'm splitting hairs here, but what trends would kind of occur where that performance would improve somewhat off of a of high single digit, low double digit decline in 2Q?

Speaker 5

Yeah. It's a good question, Michael. I'd say there's there's two things going on there. The the first one is, when you land at the 10%, there's probably a little bit of false precision around the division of what was non iDose versus iDose even in the the comparable period last year, the 2024. I'll just reiterate what we said, which is I think the combined stint plus expiration of the high gross royalty impact was a high single digit year over year impact.

Speaker 5

Now you you you raised a good point around the q two trend, and we had anticipated that that q two was gonna represent the peak of the headwind, if you will. Even when we set guidance last quarter, we had made that assumption when we talked about the full year kind of being in that mid single digit, headwind, area. And so we're the the reason for that is there was a a little bit of, it was tougher comp, if you will, in the second quarter given some of the dynamics and ordering patterns that happened in q two of last year in the non IGOS business that, that ease that we go forward here. And and we're seeing some of those trends play out, already as we make our way here through July. So I think we're confident that we've seen the peak of that headwind.

Speaker 5

And as we think about the remainder of the year, it should go back down to something that's in that mid single digits both for Q3 and Q4 as a headwind.

Speaker 13

Got it. That's really helpful, Joe. And then maybe a quick follow-up. I think in some of the prepared remarks at the opening of the call, you had mentioned ex some of the investments made in 2Q, you might have generated about $4,000,000 of cash from operations. Just wanted to dig a little deeper there.

Speaker 13

And, you know, on an underlying basis, you know, how are you thinking about, cash flow generation in the near and midterm?

Speaker 2

Hey, Mike. It's Alex. I'll take that one. And and just to give you a little more flavor on the, cash for the quarter and what Tom was saying in his prepared remarks, yeah, if you look at the change in cash between the end of the last quarter and the end of this quarter, that change has actually declined about 25,000,000. But as Tom mentioned in his remarks, there were two transactions that occurred in the quarter.

Speaker 2

The first was the purchase of a building adjacent to our headquarters, and the second was the the acquisition of of Mobius Therapeutics. The sum of those is about $30,000,000. So when you take that and and take that out of the negative 25, you end up it's actually 29,000,000. So you end up around a plus four, four and a half of cash generation in the quarter, and that's kind of the details around that. As we think about going forward, again, we continue to, have the near term goal to manage, our business such that we we march towards cash flow breakeven or or maybe small amounts of cash flow generation.

Speaker 2

You know, our our goal continues to strike the right balance between our revenues and cash generation against the investments needed in both our new product launches and our rich pipeline, you know, that you heard about as well in Tom's prepared remarks.

Speaker 5

Well, I think it's also worth adding that that with, with iDose growth, clearly comes as we have long dated terms, as you expect, with a with any new product launch. And so as we make our way through and you see this, there's a lag effect there to the cash flow benefit, the earliest of which you're starting to see, obviously, in the Q2 period that Alex was just talking about.

Speaker 8

Really helpful. Thank you.

Operator

Your next question comes from Mason Carrico with Stephens. Please go ahead.

Speaker 5

Hey. Thanks for fitting me in here. I'll ask my two upfront if that's easier here. When it comes to commercial payers, what are your expectations around how iDose is implemented into those coverage policies? I mean, there an opportunity for it to be incorporated first line?

Speaker 5

Should we be thinking about it as a second or third line potentially? And then as a second question, could you give us some insight into where iDose margins stand today? Does that product become accretive to overall corporate gross margins? Thanks. Yeah, Mason.

Speaker 5

I'll start off, and then Alex can answer the latter or the second question there.

Speaker 8

The good news is

Speaker 5

on the commercial payer policies, we we actually have a a pretty high number of policies that we can point to in in support of this answer. I mean, in fact, both on the commercial policy standpoint as well as Medicare Advantage, over 50% of of lives, have a positive policy in place today, and the vast majority of the remainder are silent. And every day that goes by, we're we're adjudicating claims within, those environments to get confidence that that patients can have access with those with those with those policies or those plans. The the reality of the existing policy framework is the majority or have an iDose is either a second or third line procedure, and it's entirely consistent with Darissa that obviously has been approved for a couple of years now. And so, really, the the policies themselves will differ, often requiring, you know, failure either on a single medication or two medications or a single medication, some form of an intervention, prior to turning to to iDose.

Speaker 5

That's, okay for us, obviously, out of the gate if we're if we're launching the product. But you can imagine over time, we'll continue to work on evidence and education of these payers to drive the the IOS procedure closer and closer to first line therapy where we we believe it ultimately should belong over over the the the next decade plus.

Speaker 2

And then, Mason, on the margin, you know, it's a great question. I'm glad you asked it because we were really pleased to see the margins come in at 83% in the quarter, and that represented really modest accretion both on a year over year and a quarter over quarter basis. And it also continues to be in this 82 to 84% range that we've been guiding to all year. And we've said for some time now that with iDose, as you mentioned, you know, that that is a high margin product. And with success in the commercialization of of iDose, we'd expect to see accretion in the gross margin over time.

Speaker 2

We hope that we're starting to see it now and that we'll continue to see modest accretion over the remaining quarters here.

Speaker 5

Got it. Thank you.

Operator

Your next question comes from Anthony Petrone with Mizuho Group. Please go ahead.

Speaker 14

Thanks. And I'll stick to two on iDose here. And one maybe just when you think about, the cadence that we're seeing now, I mean, how much is is from, you know, sort of sort of early adopters here that have been, you know, with the iDose now maybe for a few quarters, them increasing utilization versus new physician adds. And then maybe just an update on managed care coverage, you know, for iDose. It sounds like based on some channel checks, you're starting to see a little bit of movement there.

Speaker 14

No official formulary coverage, but there is some claims being processed. So anything you can share on the managed care front for iDose would be helpful. Thanks.

Speaker 5

Yeah, Anthony. First, the there's always a lag effect as we as I mentioned earlier around, physician awareness adoption and and then ultimately the the procedure volumes associated with that. These folks, as you know, in in have backlog in terms of procedures and when they get scheduled. And so what we're seeing is a mix of, expanding, I'll call it, new physicians and the early, dabbling, if you will, before they fully adopt, combined with increasing utilization of those early adopters. And really tying into the second part of your question, what we're starting to see in its earliest phases is for those earliest adopters who are now really going closer and closer to full scale.

Speaker 5

They're starting to expand into that broader, patient population of commercially covered lives as well as Medicare Advantage lots. There's obviously a process with that. It's different than dealing with Medicare, as as you know. And so the way we really continue to handle this is, methodical call, then maybe walk and and ultimately, hopefully, jog and run as we make our way through the coming quarters and and years on an account by account basis. You really have to make sure that even when you've got, proper policies in place that the account, the practice are doing benefits verification, contracting, prior authorizations, claim processing, and all the things associated with proper managed care, you know, lives, that they're doing it, in the right way.

Speaker 5

You wanna ensure that success. So we are we're we're moving, intentionally, in a very methodical manner to to make sure that they have a positive outcome, payer by payer and situation by situation as they continue to grow. Over time, we obviously expect this this to be a significant portion of our business, especially the commercially covered lives, but we wanna make sure that we set them up for success out of the gate here.

Speaker 7

Thank you.

Operator

Your final question comes from Danielle Antalffy with UBS. Please go ahead.

Speaker 15

Hey, good afternoon, guys. Thanks so much for taking the question. Congrats on a strong quarter here. Just a question on where you're seeing physicians adopt iDose. Could you maybe talk a little bit about how they're balancing iDose versus iStent and sort of what the decision pathway is to to go with iDose versus iStent?

Speaker 15

And maybe just because it could serve as a snapshot of, you know, five years from now, how these two different product lines are are coexisting? Thanks so much.

Speaker 5

Yeah. Thanks, Danielle. And, obviously, it's still early days, and so, you have to sort of focus in more on those physicians who are adopting and are at the phase that, Anthony's prior question are are earlier adopters who are now moving into a part of their everyday, you know, practice paradigm in managing patients with glaucoma. And I think what you're starting to see for those folks who are in that is that iDose becomes their foundational therapy. That's where they go first and foremost.

Speaker 5

That shouldn't be a surprise given how wide open that label is and the ability to treat patients up and down the the disease spectrum. And they then turn increasingly to the iStent or iStent infinite, whether that be standalone or in combination, at times with with iDose, to manage those patients who are progressing. They may have failed on a few more therapies along the way, and they wanna make sure that they they really take every chance to arrest the progression of that disease and hopefully avoid, the progression towards a more invasive, procedure like a tube or trash or other, alternatives.

Operator

That concludes our question and answer session. I will now turn the call back over to the company for closing remarks.

Speaker 3

Okay. Thank you all for your time and attention today. And again, we thank you for your continued interest and support of Galkos.

Speaker 8

Goodbye.

Operator

Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

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