Priority Technology Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 20, 2025

There are 13 speakers on the call.

Operator

Welcome to Glaukos Corporation's Fourth Quarter and Full Year twenty twenty four 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.glovcalls.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.

Speaker 1

Thank you and good afternoon. Joining me today are Blanco's 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, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may 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.

Speaker 1

You'll find these documents in the Investors section of our website at www.glaukos.com. Finally, please note that during today's call, we will also discuss certain non GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in the 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 2

Thanks, Chris. Good afternoon, and thank you all for joining us today. Today, Glaukos reported record fourth quarter consolidated net sales of $105,500,000 up 28% versus the year ago quarter. These results reflect the continued acceleration of our business and cap off a successful year of global execution, both from a commercial and development perspective, leaving us ideally positioned to sustain our momentum and execute our strategic plans in 2025 and beyond. For the full year 2024, consolidated record net sales of $383,500,000 grew versus 2023.

Speaker 2

We have also introduced full year 2025 net sales guidance range of $475,000,000 to $485,000,000 Our record performance in the fourth quarter and full year 2024 reflects our unwavering dedication to advancing our mission to transform vision by pioneering novel, dropless platforms that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight threatening chronic eye diseases. At Glaukos, we are in the business of pioneering entirely new marketplaces within ophthalmology. Innovation is at the core of everything we do. Our mantra, we'll go first, embodies our commitment and determination to take chances, push the limits of science, and disrupt the legacy treatment paradigms in glaucoma, rare disease, and retinal diseases through our pursuit of game changing technologies. Our fourth quarter and full year record of results were primarily driven by both our US and international glaucoma franchises, where we continue to accelerate efforts to pioneer and develop the interventional glaucoma or IgE marketplace with new standalone therapies designed to slow disease progression and reduce drug burden for the benefit of physicians and patients.

Speaker 2

Our goal to advance and improve glaucoma treatment by driving earlier intervention continues to build momentum as we educate surgeons and thought leaders globally to organically drive this broader evolution in the standard of care for the benefit of patients. While we remain in the early stages of these IG efforts, we are encouraged with the increasing levels of clinical interest for this paradigm changing evolution. Within our U. S. Glaucoma franchise, we delivered record fourth quarter net sales of $56,300,000 on strong year over year accelerating growth of 45%, driven primarily by growing contributions from iDose TR.

Speaker 2

As we pass the one year anniversary of our controlled launch of iDose TR, I could not be more pleased with our team's execution of our plans for this first of its kind intracameral procedural pharmaceutical that was designed to continuously deliver glaucoma drug therapy for up to three years. Over the course of 2024, we accomplished several key objectives that together create a strong foundation to support our future iDose growth plans that include, one, developing and implementing a superlative training program to support a growing number of trained surgeons and accounts, Two, building an expanding set of clinical literature, now consisting of nine different peer reviewed publications highlighting iDose TR as a transformative new treatment alternative for patients suffering with glaucoma and ocular hypertension. And three, establishing key market access objectives to create an optimal reimbursement environment through a permanent J code, a facility fee, a published ASP from CMS, building professional fee coverage and payment from Max, and expanding commercial and Medicare Advantage coverage. Most importantly, clinical outcomes and product feedback from a growing number of cases and trained surgeons continue to be very positive and reaffirms our view that with the launch of Itos TR, we are pioneering a brand new therapeutic category that has the potential to reshape glaucoma management as we know it today.

Speaker 2

Coming off of our national sales meeting earlier this month, the energy and excitement from our sales team and commercial organization, Varietos TR, and our broader interventional glaucoma strategy was profound. Our primary near term focus remains on broadening market access among max, commercial, and Medicare Advantage payers. While there is certainly more work to do here, particularly as we expand efforts into the commercial arena over the course of 2025 and beyond, We are encouraged by the overall progress our teams are making to support increased reimbursement confidence through more streamlined and consistent J code coverage and payment in the majority of MACs to date with more to come. Alongside this, we're also making good progress securing professional fee coverage and payment with three of the seven MACs now including CPT code 660T in their professional fee schedules at rates in line with our expectations and generally consistent with comparable standalone glaucoma procedures. As noted in the past, we expect increasing adoption as reimbursement confidence is gained by our customers over the course of 2025.

Speaker 2

This will further be supported by our plan to accelerate marketing investments as the universe of trained surgeons and accounts continue to expand. While we advance our iDose TR efforts commercially, we also plan to expand the robust body of clinical evidence for iDose TR. On that front, we recently announced several positive iDose clinical studies. First, a new thirty six month follow-up analysis of iDose TR's two phase three pivotal clinical trials demonstrating sustained substantial IOP reductions as approximately seventy percent of I DOS TR subjects remain well controlled on the same or fewer IOP lowering topical medications at thirty six months after a single administration of INOS TR versus fifty eight percent of Timolol control subjects. In addition, INOS TR continued to demonstrate excellent tolerability and a favorable safety profile through thirty six months across both Phase three trials.

Speaker 2

Second, a new six month follow-up analysis of a Phase four single arm clinical study demonstrated iDose TR implanted in combination with cataract surgery achieved a profound mean IOP reduction of 11.3 millimeters Hg or 44% at six months compared to baseline. And last but certainly not least, we commenced a Phase IIB3 clinical program for iDose, T Rex, our next generation iDose therapy. IDose T Rex is designed to be very similar in size and form factor to the original iDose TR, but it has nearly twice the drug capacity. Shifting to our US stent business, the utilization of iStent infinite for glaucoma patients that have failed medical and surgical therapy continues to expand as our ongoing clinical educational efforts and improving market access landscape take hold. During the fourth quarter, '5 of the seven MAX implemented final updated MIGS LCDs that established coverage for iStent infinite that is consistent with our original reconsideration request.

Speaker 2

In addition, these final LCDs also eliminated coverage for cases that utilized two different MIGS devices in the same procedure. As anticipated, we believe these LCDs did cause some transient turbulence in the market during the fourth quarter, and we expect this may continue into 2025 as providers continue to navigate the impacts associated with these LCDs. Moving on, our international glaucoma franchise also delivered record net sales of $27,900,000 on year over year growth of 28% on a reported basis and 29% 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 a standard of care in each region and major market in the world. Consistent with prior quarters in 2024, our new French Health Authority rebate agreement was favorable to our fourth quarter reported revenues.

Speaker 2

This year over year growth tailwind will sunset in 2025. We remain in the early stages of expanding our IG and product portfolio initiatives globally ahead of anticipated new product approvals and expanding market access in the years to come. As previously discussed, we expect the trialing of new competitive products in some of our major international markets may become an increasing headwind this year alongside the material foreign currency exchange headwinds that emerged at the end of twenty twenty four and have continued into 2025. And finally, our Corneal Health franchise delivered net sales of $21,400,000 including Fotrexa net sales of $18,800,000 As discussed throughout 2024, our fourth quarter results reflect the growing impact of Fotrexa realized revenues as a result of our entry as a company into the Medicaid drug rebate program or MDRP. Going forward, we will continue to focus on expanding access for keratoconus patients suffering from this rare disease.

Speaker 2

Staying on corneal health and shifting to our pipeline, in December 2024, we are pleased to announce NDA's submission of Epioxa, our next generation corneal cross linking eye link therapy for the treatment of keratoconus, a site threatening disease. This submission sets up an anticipated FDA approval decision by the end of twenty twenty five. The NDA submission for Epioxa represents an important milestone for our company, as it brings us one step closer in being able to provide keratoconus patients and the ophthalmic community with the first FDA approved noninvasive corneal cross linking drug therapy that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. We look forward to working closely with the FDA in their pending review process and continue to believe that Epioxa, which is designed to reduce procedure times to improve patient comfort and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus. We are already well underway with a team of cross functional leaders across our commercial and market access organizations in the preparation and planning of the Epioxa commercial launch targeted for next year.

Speaker 2

It's worth reminding investors that an Epioxa approval also provides us with the opportunity to launch a rare disease pharmaceutical supported by the right long term pillars to optimize patient access, a persistent and at times frustrating challenge for us historically with Fotrexone. We also continue to advance a Phase II clinical program for our third generation EyeLink therapy designed to use biomechanical modeling to deliver a customized pattern cross linking treatment tailored to each patient's unique corneal topography. Beyond our cross linking franchise, we continue to prudently invest in and successfully advance our broader 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. In addition to our pipeline milestones already discussed, we anticipate commencing a Phase II trial for I lution blepharitis along with a US ID trial for pressiflow MicroShunt in 2025. As we've discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk based spending and our capital position now and in the future.

Speaker 2

One such area of planned investment is in our operations function, where we recently announced plans to build an expansive research development and manufacturing facility in Huntsville, Alabama to augment our current infrastructure and support our future expansion plans. Over the course of 2024, we successfully executed several transactions designed to further solidify our already strong capital position, including the retirement of the full $287,500,000 in principal amount of our convertible senior notes due 2027, leading to a deleveraging and de risking of our balance sheet as well as a significant reduction in future cash interest expense. In addition, during the fourth quarter, we successfully unwound 50% of our cap call transactions associated with this convertible note issuance, generating cash proceeds of approximately $53,000,000 for our company. As a result, we ended 2024 in a strong capital position with cash and equivalents of roughly $324,000,000 and no debt. In conclusion, I'd like to recognize our more than 1,000 employees around the globe for whom our company mantra of We'll Go First is more than just a company tagline.

Speaker 2

Rather, it is something that defines who we are as an organization and how we lead every day. I believe our foundation has never been stronger and our prospects never as promising. We are excited to build upon the growing momentum in our business in 2025 and beyond as we advance our mission to transform vision for the benefit of patients worldwide. So with that, I'll open the call for questions. Operator?

Operator

Thank you. We will now begin the question and answer session. And your next and your first question comes from the line of Tom Steven with Stifel. Your line is open.

Speaker 3

Great. Hey, guys. Thanks for the questions. Tom or Joe, to start with you, can you elaborate a bit on just the trends you saw with Eidos in the quarter and then maybe observations year to date? Obviously, a lot of investor focus on the ramp.

Speaker 3

So I guess I'm just wondering if there was anything to call out in terms of new factors that have emerged the blade, and maybe anything that's different from plan?

Speaker 4

Sure. Hi, Tom. It's Joe. I'll start and if Tom wants that, I think he can at the end. I would really characterize through the quarter another strong quarter of performance really heads down execution on all fronts and that led to what I believe would be probably a doubling of iDose TR revenues in most of your models in the quarter relative to what we saw in the third.

Speaker 4

I think more importantly underneath that as we think about the building blocks of what it takes to build the foundation for long term success and kind of our progress there, first and foremost, we continue to be really pleased with the real world outcomes clinically, and that's further supported by the growing body of peer reviewed evidence that Tom mentioned in his prepared remarks. We continue to see the number of surgeons, trained expand rapidly on iDose and parallel the education of the office staff on the reimbursement dynamics associated with a procedural pharmaceutical like iDose. And then on the reimbursement front, we continue to make progress in establishing confidence. It's subjective as I've said before, but I can now say that five of the seven MACs are adjudicating and processing the J code in a normalized and efficient manner. That's really kind of emerged here over the course of the beginning of 2025, but an important milestone is we continue to make progress on that front.

Speaker 4

And then as Tom mentioned, we've recently added Novitas and First Coast alongside Meridian as having established formal professional fee schedules associated with Eidos. And and finally, you know, as I think about us, you know, as we move forward here, we'll begin to slowly and methodically roll out that commercial and Medicare Advantage policies as we and support that as we enter into Q2 and certainly in the second half of the year. These are all consistent with what we've been saying now for a couple of quarters and we continue to remain on track. So from a macro standpoint, as we sit here today, I think we have growing confidence, on the impact that iDose is going to have in the years ahead, including the impact it's going to have on 2025 as that reflect in our guidance I'm sure we'll get into here in a bit. Of course, having said that, I'll continue to remind folks that as a procedural pharmaceutical, the adoption ecosystem is pretty complex, just as it was when we launched iStent many years ago.

Speaker 4

So progress from a reimbursement confidence and established pro fee schedules are exactly that. They can sometimes take a few quarters and move the needle, but we're excited about what we just did in the fourth quarter and what it means as a setup for 2025 and beyond.

Speaker 3

That's great color. And then my follow-up just on guidance, Joe or Alex, can you just elaborate a bit on the components of the 2025 revenue guide between the different segments? And any color on the core U. S. Stem business growth as well would be helpful.

Speaker 3

Maybe it seems like that slowed a bit due to the LCDs in 4Q, but just any color on the component of guidance components of guidance would be great.

Speaker 4

Thanks. Yes, it did, Tom. And so let me break down kind of the how to understand, I think, the fourth quarter, and then certainly as we think more importantly, I think in the guidance looking forward. Specific to the latter part of your question, we did see the new LCD restrictions slow our non IDOS or STIP growth, if you will, down to kind of the mid single digits for the quarter. Obviously, that was more than offset by the IDOS performance that I referenced in the first part of your question.

Speaker 4

And so as we think forward on the guidance around that specific point, and I'll save more color for other folks to ask the questions on. As we think about that guidance, we do expect those LCD headwinds and the volatility that we told you all to expect, as well as the expiration of the Hydrus royalty to generate flat to maybe even down low single digit growth for our non Eidos revenues in 2025. So when you kind of put all that together and again we'll talk about it a bit more throughout the call, you'll see that decline in our guidance is very healthy expectations around the Eidos franchise and really growing as we've made our way into 2025 and what we think we'll accomplish this year with Eidos.

Speaker 3

That's great color. Thanks, Joe.

Operator

Your next question comes from the line of Larry Digelson with Wells Fargo. Your line is open.

Speaker 5

Hey, guys. Congrats on the quarter. Thanks for taking the questions. This is Simran on for Larry. Maybe just to follow-up a bit on the 2025 guidance.

Speaker 5

So U. S. Glaucoma, it sounds like the core business should continue to see some of those headwinds from the LCDs. Is that, how do we think about cadence in terms of impact? Is that first half weighted and some return to growth in the second half?

Speaker 5

Or do you sort of expect to see depressed volumes throughout the year? And how do we think about the cadence of Eidos throughout 2025?

Speaker 4

Deborah, it's Joe. So maybe I'll start in reverse and just talk about seasonality for a second, then I'll get into the question around the LCD headwind. So as you know, having been around storage for a while, typical seasonality patterns, for us are underweight in the first quarter and sort of equal weight in the middle part of the year and then pretty heavy into the fourth quarter. Clearly, the dynamics around iDose are going to drive an increasing weighting towards the second half. I would point investors to something that's probably a little closer to call it 21% contribution in the first quarter, '20 '3 percent, '20 '4 percent in the second quarter, '20 '5 percent in the third and 30% in the fourth.

Speaker 4

And again, that's really largely driven by just the continued expectations of ramp, for Eidos within that. And that leads into sort of the second part of your maybe it was the first part of your question. I think we certainly would expect that the LCD headwinds would be at their peak here in the first half of the year and start to abate a little bit as we get in the second half. It's certainly as given the fourth quarter where you already experienced a little bit of that headwind related slowing in the fourth quarter of twenty twenty four. So I don't think it's just something that's equal throughout the year.

Speaker 4

I think we should see some improvement over that. But as I said in the prior question, we do expect for the overall year the combination of those MAC headwinds as well as the expiration of the Hydros royalty, which really begins in the second quarter, driving flat to potentially even down low single digits growth for the non high dose part of our U. S. Welcome of business.

Speaker 5

Got it. That's very helpful. And maybe just a bigger picture question on, how we should be thinking about IDOS sales. If I look at, total MIGS procedures in 2024, it looks like there were about 100,000 procedures, and the patient population is only about 500,000 to 700,000 eyes. Could the number of IDOS procedures eventually surpass the number of implantable MIGS procedures in The US?

Speaker 4

Hi, Tim. I think over the medium to long term, absolutely, especially with the numbers that you just put out there. But maybe to supplement that, what you just said a bit, I think the overall, I'll call it glaucoma procedures market, which includes MIGS as we define it, maybe some of the more tissue destructive procedures, is probably more like 200,000 to 250,000 procedures a year that are being done. That's largely today, as you know, done in combination with cataract and that's where you reference the five hundred thousand to seven hundred thousand eye market. When we talk about eye dose or quite frankly eye sin infinite or interventional glaucoma overall, you are going after a much, much larger market.

Speaker 4

So when we think about that, there are north of twenty million eyes at any given time that have either after hypertension or glaucoma in The US. Somewhere in the neighborhood of thirteen million to fourteen million of those are diagnosed at any given time and around ten million are actively treated. So iDose and iCinet Infin as well as a handful of other products with much broader labels are all going after a much larger market in that 10,000,000 eye market versus the $500,000 to $700,000 that we've been constrained with in combination with cataract surgery historically.

Speaker 5

Got it. That's helpful. Thank you.

Operator

Your next question comes from the line of Ryan Zimmerman with BTIG. Your line is open.

Speaker 6

Hi. This is Izzy on for Ryan. Thanks for taking the questions. So I just wanted to stick with iDose. So over the course of 2024 and as you guys have rolled out the limited launch, I was curious if you are seeing any share gains from DERISTA?

Speaker 6

Or has the growth you've seen so far been more of expansion of the market and bringing in new users?

Speaker 4

Hi, Aditi. It's Joe. I would characterize it as more overall market growth. I think we're just as an extension of the prior question that was asked by Simran, we're in such the earliest phases of a much, much larger market movement towards standalone interventional care. I think there's a lot of opportunity for many products including obviously Derista anidose to be growing for the foreseeable future in lockstep.

Speaker 4

So I see it as an opportunity. It's less about share. I think the real question is as an industry, how do we continue to take share from legacy eye drops and the shortcomings that are with are on that front from a clinical perspective.

Speaker 6

That's helpful. Thank you. And do you have any updates on the status of re administration?

Speaker 2

Yeah, we do. I'll be happy to take that one, Izzy. This is Tom. And so as I promised investors, this is going to be a process that will take several months. Indeed, it has.

Speaker 2

We've been in negotiation with the FDA for some time. I think we're in a good position now, to be able to submit a post approval supplement to the FDA for appeal during the first half of this year. And the FDA has a statutory guideline of one hundred and eighty days once we submit that. And so we should know by the end of this year whether we're successful or not getting a re administration, claim of the iDose. I remind investors, though, that the belfin suspended approach that we have of having iDose T Rex already in a clinical trial and potentially being available during the planning period for commercial entry, I see that as a de facto next implantation design product for our current iDose product.

Speaker 2

So I think either way we're covered. We continue to be hopeful. But as I have strongly said in the past, we're not counting on anything.

Speaker 6

Understood. Thanks for taking the questions.

Operator

Your next question comes from the line of Richard Newitter with Truist Securities. Your line is open.

Speaker 7

Hi. Thanks for taking the questions. Maybe on iDose to start here, the can you give us any color on what your doctor installed base of Ida's performing physicians looks like? And anything on how you're going to progress that training effort? I know you at the last quarter said you're moving into kind of a full commercial launch and I just want to get a sense for, you know, especially exiting the quarter and you have some of the reimbursement, and Mac progress being made.

Speaker 7

How should we think about that in terms of the number of docs being trained?

Speaker 4

Yes, sure. Richard, thanks for the question. That's we have not gotten that granular around the specific numbers. What I can tell you is and there's a reason for that. Training of of of doctors in relation to ITOS is not really a primary gating item for the continued progress, of that product.

Speaker 4

The reality is that there's there are more than, several thousand, as you know, surgeons who have, sufficient training on angle based surgery and iDose is an extension of that already existing training. Of course, we we we make sure that they're, armed with the the pearls around, the little nuances of a successful outcome with the procedure. But that's really not a gating item. We've had a lot of success in training doctors to date across the country, at a pretty rapid rate. I would expect that to continue in 2025, in particular as professional fee schedules are turned on and general reimbursement confidences continue to be solidified.

Speaker 4

But that really has not been a gating item to date. We do make sure that as I referenced earlier that we're also delivering the kind of training and education of office staff on the reimbursement dynamics associated with with a procedural pharmaceutical like Eidos. It's a little different. And so we want to make sure that we're there, upfront through those early cases afterwards. And in some ways, that is a probably a bigger gating item, if you will, towards the launching and scaling of Eidos than surgical training of the doctors themselves.

Speaker 7

That's helpful. And then similar kind of question. So we recently we pulled pulled some doctors and granted, you know, small sample, but but the utilization rate that Eidos implanters are talking about, even currently as a baseline and where they expect to go, but quite high, you know, in teens per month. You know, I'm just I'm just curious, can you talk at all about, you know, what you're seeing in the range of utilization rates from kind of newer users, more timid users, maybe even users that are in more constrained reimbursement regions versus others?

Speaker 4

Yeah, absolutely. I mean, I'm not so sure that it's changed markedly except for continuing to improve. In most cases that when an account or a doctor comes online, they might do a couple of procedures to to a handful, and then wait and see, you know, how the the the payment mechanisms play out. And if they've got confidence with that, they start to scale from there. We certainly have, more than just a handful of doctors, if you will, that are now doing the kind of numbers that you're talking about on a monthly basis.

Speaker 4

And our job at this stage of the launch, alongside of the reimbursement and confidence is to turn on both the hunting and the farming element of what I just said. And and we're really just still, you know, very much in the early days of a of a ten year process, if you will, of of of driving, the optimization of both those factors. But we see a wide range. And most important underneath that, I said it earlier, is that the outcomes clinically continue to be terrific. And when you have that, and you're going after an obvious patient need, you you know where this is ultimately going.

Speaker 4

And the question is, is how fast can you turn on the the spigots, you know, doctor by doctor and account by account?

Speaker 7

Thank you.

Operator

Your next question comes from the line of Alan Gong with JPMorgan. Your line is open.

Speaker 8

Hi. Thanks for the question. I guess just touching on the rest of the business, you closed out the year with another really strong quarter from international. I understand that you're losing a bit of a tailwind from France next year, but how should we think about the growth outlook for 2025? And what kind of catalyst you might have in new geographies or any other dynamics to keep in mind over the course of the year?

Speaker 4

Yeah. That's a good question, Alan. We did have another strong quarter, some some ways surprisingly strong quarter from, our teams internationally delivered broad based growth of 28% in the quarter highlighted a year that we grew north of 20% in its entirety. Guys, we you referenced a couple of things, so I'll give you the puts and takes. I think as we move forward in 2025 implied in our guidance is something closer to high single digit growth for that business.

Speaker 4

The slowdown of that relative to what I was just describing really comes from a combination of things. First, FX headwinds probably at this point of the earnings calendar. That's not a surprise to anyone here, but it's pretty material on a year over year basis as we look at the setup for 2025. Second is potential trialing and trying of competitive product launches in Japan and France. That's also not new.

Speaker 4

We referenced that on our last quarterly call and we certainly expect as in particular Alcon gets their feet underneath them in these markets that we'll see some impact, if not transit impact on our business there. And the last is what you referenced as the lapping of the tailwind from the amended French rebate agreement. And so when you put all those things together, that lands us on that sort of high single digit expectation for the international glaucoma business. There are things that we're waiting on. For example, we've been talking for a little while.

Speaker 4

It's an opaque process to us, but getting the MDR approval for ISAT INFINIT in Europe in particular is a big growth driver that we've not currently baked into our forecast. We really can't until we've received that given, again, the nature of the way the regulatory process now works in Europe. But that has a broader implication to many of the markets around the world for that product and reimbursement associated with it. So, that probably being the single biggest one I would say could drive upside, to the guidance that we just provided. Got it.

Speaker 8

Thank you. That's all for me.

Operator

Your next question comes from the line of Mike Sciaccini with Jefferies. Your line is open.

Speaker 9

Hey, good afternoon and thanks for taking the questions. Just to start, was hoping you can give us an update on iDose Trio, where you stand there and any change or give us a reminder of what you're expecting on commercial timeline?

Speaker 2

Yeah. I'd be happy to, Mike. This is Tom. And so the iDose Trio, as we talked about, is going to be a really a modification of our existing applicator. And we believe that it will take us from right now, typically, the incision size for an iDose implantation is about 2.5 millimeters.

Speaker 2

And so our hope is to get that down with iDose Trio somewhere in the neighborhood of one millimeter. At one millimeter, you have a significantly closed chamber and you have very reduced risk for any dehiscence of the, aqueous humor coming out of the eye and you're able to maintain chamber pressure. So for those reasons, we think that that proportionally, this will be a, in the favor of moving into the in office for clinicians, which has been part of our plan, during this planning period process. The FDA, has in the drug division requires a small safety study to be done. And so we'll be in the process mid year or so of beginning a small safety study with the FDA.

Speaker 2

We'll need to follow those patients for a period of time. And so our expectation is to have the iDose Trio product available in 2026, which is going to align quite nicely with our approach with MACs as we seek MAC by MAC to establish the appropriate payments for this modified code, to be able to give surgeons the reimbursement capability and predictability of doing these in office. So we like what we see. We like how it lines up. And we think, certainly by year end 2026, we'll have this product in the commercial marketplace.

Speaker 9

Great. Thanks, Tom. That's helpful. And I guess just a follow-up for me. As you think about 2025 guidance, I guess can you talk about how you're thinking about iDose growth expectations just in the context of is this primarily a continuation of penetrating the Medicare population?

Speaker 9

Or do you have anything baked into expectations for starting to see some benefit from any traction on the commercial side? Thank you.

Speaker 4

Yes, Mike. I think you can imagine the lion's share, if not all, of what the expectations at this point in the year are really being driven by the continued MAC progress, if you will, both in terms of the reimbursement certainty around the J code and those final two MACs as well as the professional fee schedules that we expect to continue to come out as we make progress there. That really forms, I'll call it the foundation of it. As we make our way in the latter part of the year, we do expect, but we do some commercial Medicare Advantage volumes to come in. But I will tell you that, as you can expect from us, we are going to be very, very methodical in the launch of that.

Speaker 4

You want to make sure that these customers, can master that process of the prior authorizations and the various things that come along with an expansion outside of traditional Medicare fee for service. So, we're not going to chase volume there. We're going to make sure the customers are ready, and then we're going to continue to expand there as we make our way through the year.

Speaker 9

Great. Thank you.

Operator

Your next question comes from the line of Mason Perico with Stephens. Your line is

Speaker 10

open. Great. Hey, thanks for the questions here. Could you talk about initial doc reception to the Phase four data in that combo cataract trials? Then there have been a noticeable change at all in utilization following you guys releasing that?

Speaker 10

And then just as a second follow-up there, for the MAX where payment dynamics for the J code and pro fee are farthest along, could you just talk about what utilization looks like in the combo cataract setting in those jurisdictions?

Speaker 4

Yeah. Hi, Mason. It's Joe. I think obviously the data that we've now put out there around combination cataract utility of ITOS is terrific. And sort of goes in line with what we would expect given the strength of ITOS as a standalone procedure.

Speaker 4

And when you get that, a benefit of the cataract procedure in it. It's certainly taken notice, I think, you know, to the second part of your question, what you see in those MAC zones where you have, call it a little bit more seasoned J code experience around with certainty and now established professional fees is growth across the board. You see expansion within the accounts, the number of doctors, etcetera, doing the procedure and doing it largely at standalone. But as a percentage of the mix, you're starting to see a little bit more combo cataract, which you'd expect. So as they've got their C legs with the procedure and confidence in the outcomes and you combine with this data, it's only natural that they would start to utilize this as well, in combination with with cataract surgery for those patients that they think it qualifies for.

Speaker 4

So we are seeing it, but I would tell you that our reason for being obviously is driving the much larger opportunity of interventional glaucoma and stand alone procedures. But it doesn't surprise me that falling on behind that is some cataract utilization as well.

Speaker 10

Got it. I'll keep it at that. Thanks.

Speaker 3

Thanks, Mason.

Operator

Your next question comes from the line of Anthony Petrone with Mizuho. Your line is open.

Speaker 11

Thanks. Maybe sticking on just Mac dynamic here. The two Macs that issued the pro fees this quarter, like when did that happen in the quarter A? And in those MAX, when do you think they'll catch up, just in terms of billing cadence to Meridian? And then I'll have a quick follow-up.

Speaker 4

Yeah. Hi, Anthony. I'd say first, the professional fee schedules were announced in mid January. They were, I think, retroactive to January 1. And that's one piece of that equation, a very important one.

Speaker 4

As you know, then it's got to be all in their systems and adjudicated properly. Sometimes that can take a little bit of time before you start to see the recurring consistent nature of those payments, but we have started to see that. And then realistically, the impact of the the the rollout of of that and it kind of goes back to what I was saying earlier, you know, these things don't just happen overnight. There's an education process that goes along there. There's a confidence billing process that the account and the doctors see that they're being, you know, properly compensated for their time for the procedure.

Speaker 4

So it's something that rolls out over many quarters, if you will, in getting that confidence and then expanding that confidence in many more surgeons. We've seen that in Meridian to your point, where the professional fee schedule was put out earlier in the end of, I think, the third quarter going to the fourth quarter of last year. And we're still in the process of making sure that accounts and surgeons are aware of that update and driving increasing utilization clinically alongside of it. So it's a journey on that front, and one that we've done many times in the past and we're executing quite well on, I think, today.

Speaker 11

And just a quick follow-up for modeling. U. S. MIGS and U. S.

Speaker 11

Corneal, they'll call it headwinds you referenced to Joe in a prior question. I think the message here is to essentially have U. S. MIGS maybe flat. I don't know if you were messaging down, but maybe to just touch on that a little bit.

Speaker 11

And then just the comments in the presentation there, U. S. Corneal seeing some headwinds too, maybe just a little direction there would help. Thanks again.

Speaker 4

Yeah. Maybe I'll just I'll bring it all back together again for each of the franchises on the guidance side. You heard me reference earlier the seasonality, so I won't go through that again. On the Corneal Health side, I think we believe that the year over year growth headwind from MDRP will probably peak somewhere in Q1, certainly in the first half. And then ultimately, this franchise can deliver kind of low single digit growth for the entirety of the year.

Speaker 4

Certainly ahead of what we expect will be an exciting year in 2026 with the launch of EpiOX. This year is all about navigating, the continued MDRP headwinds, and sunsetting or lapping some of the impact we saw in 2024 as we make our way through this year. So low single digit growth in 2025 for cornea. You heard me talk about international growth, glaucoma and the growth expectations there of high single digits. And then on The U.

Speaker 4

S. Side, what I said was we expect the combination of the LCD headwinds and volatility and the expiration of the Hydrus royalty to generate flat to potentially down low single digit growth for our non IDOS revenues in 2025. Obviously, that's something we're going to watch closely, and continue to update you all on as we make our way through the year. But when you put all that together, I think it's going to imply in your models initial items expectations that are certainly well north of $100,000,000 for the year, which as you would expect are more weighted towards the second half and Q4 in particular given the continued progress we expect to make throughout the year.

Speaker 11

Very helpful. Thanks.

Operator

Your next question comes from the line of Stephen Leishman with Oppenheimer. Your line is open.

Speaker 7

Hi, this is Ryan, for Steve today. I just wanted to ask a little bit about what you guys are seeing in terms of uptake in iDose in different facilities and systems. Given the high cost of carrying the inventory, are you seeing that any difference between larger and smaller facilities, wanting to adopt the device? And do you have any plans on working with people to make sure that

Speaker 10

they can carry it to

Speaker 7

make it affordable for them?

Speaker 4

Yeah. So I mean, I think first off, the relative cost and the carrying cost of it, you know, we mitigate a lot of that as is often the case with pharmaceutical launches as like Eidos with longer dated terms. You've probably seen that in our accounts receivable balance. Again, very common with pharmaceutical industry standards. And so the actual, I'll call it cash component of that for facilities, we mitigate that way and we've been pretty successful in doing it.

Speaker 4

I think there's always a delta between the administration and bureaucracy of larger hospital systems and things like that where you have to go through committees and get a lot more sign offs, if you will, to get going even when the physician customers themselves are ready and want to do it clinically, versus the nimbleness that exists with your average ASC customer, if you will. So I think so far, we've certainly been much more indexed, if you will, towards the ASC side of things. But we certainly expect, with the progress we're making, the hospital side of our business will continue to make progress in 2025.

Speaker 7

Great. Very helpful. Thank you.

Operator

And your next question comes from the line of Danielle Antalffy with UBS. Your line is open.

Speaker 12

Hey, good afternoon, everyone. Thank you so much for taking the question. I just have a kind of high level question. Sorry, I'm going to stick on IDOS for a second. When we were working on our initiation, we looked back at iStent in the first few years of launching and it looks like you guys sold over, call it, 100,000 iStent in the first three years of launching, but back in 2012, you know, 2012, '20 '15.

Speaker 12

So I guess my question is, what's different about the iDose launch versus when you launched iStent? I appreciate it was like twelve years ago, but, that it wouldn't happen quite as quickly because obviously at a 13.5 ASP, you know, you don't need, you know, a high volume to get to pretty big numbers. So just if you could help me better understand the difference between the two launches and what the gating factors are, that would be great.

Speaker 4

Sure. And I mean, and I'll start and candidly, Tom was a part of that first launch, much more than certainly I was. But when we think about the comparison here of the two, there are pluses and minuses in each, right? The most similar element of the launch is that you're pioneering a new category, period. And you're doing it in a procedural based environment.

Speaker 4

And so that means you're not just delivering clinical excellence and training, but you're changing practice and physician behavior. That was true back then with iStent in the combination of cataract surgery and it's true now with iDose in the context of driving procedural pharmaceutical. It's certainly standalone, interventional glaucoma, as a as a general, you know, matter. The the the you know, today, we obviously have a lot more doctors to the point from the earlier questions who are trained on angle based surgery. So the training element to these physicians, that hurdle is much lower than it was ten years ago when we were in the middle of really launching, iStent.

Speaker 4

At the same time today, we're obviously going after a much larger market, but we know that's going to take many years to continue to develop and shift the standard of care within it. Those are those are all positives. On the flip side, reimbursement, which was always a consideration back than it is today when you're dealing with a more premium priced, you know, procedural pharmaceutical is front and center as our patient economics. And I would also add in that you know, the Medicare Advantage dynamic is much more real today than it was, you know, ten and fifteen years ago. And so we have to navigate, you know, Medicare covered lives that are covered in a in a less, comprehensive way than traditional fee for service.

Speaker 4

And so that's an impact obviously to the overall opportunities there. But I think when you put it all together candidly, there's a lot of apples and oranges there. And it's hard to draw a direct correlation. I think it's probably better to just focus on what you think around the opportunity first within fee for service, Medicare, the stand alone patients and combination cataract and then ultimately in the commercial and Medicare Advantage and the individual situations that can drive it. The kinds of patients that are ideal candidates, whether they're, suffering from things like mobility issues or forgetfulness or all the various things that really present more lower hanging fruit for why a surgeon would make the move in intermission glaucoma versus just prescribing more drops.

Speaker 12

Okay. Super helpful. Thank you so much.

Operator

And that concludes our question and answer session. I would now like to turn it back over to management for closing remarks.

Speaker 2

Okay. I want to thank you all for your time and attention today. And thank you as well for your continued interest and support of Glaukos. Thanks again. Goodbye.

Operator

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

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Priority Technology Q4 2024
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