Q1 2025 Glaukos Corp Earnings Call
Operator: Welcome to Glaukos Corporation First Quarter 2025 Financial Results Conference Call.
Welcome to Black Hills Corporation's first quarter 2025 financial results conference call copies of the Companys press release and quarterly summary documents both issued after the market closed today are available at Www Dot Graco Dot com.
Operator: Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com. As a reminder, all lines are muted until the end of today's presentation, where we will have a question and answer session. If you would like to ask a question during that time, press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star followed by the number 1.
As a reminder, all lines are on mute it until the end up today's presentation. We will have a question and answer session. If you'd like to ask a question during that time press star followed by the number one on your telephone keypad, if you're about to withdraw your question Press Star followed by the number one.
Operator: This call is being recorded and an archived replay will be made available online in the Investor Relations section of www.glaukos.com.
This call is being recorded and an archived replay will be made available on the online in the Investor Relations section of.
Www dot black holes dot com.
Christopher Lewis: I will now turn today's call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead. Thank you and good afternoon.
Speaker Change: Now I'll turn today's call over to Chris Lewis, Vice President of Investor Relations and corporate Affairs. Please go ahead.
Chris Lewis: Thank you and good afternoon.
Christopher Lewis: Joining me today are Glaukos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details key facts associated with the quarter the state of the company's business objectives and strategies and any forward statements for guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call.
Speaker Change: Joining me today are bloggers, chairman and CEO, Tom Burns, President and CEO, Joe Gilliam, and CFO, Alex serving similar to prior quarters. The company has posted a document on our Investor Relations website under the financials and filings quarterly results section titled Quarterly summary.
<unk> is designed to provide the investment community with a summarized and easily accessible reference document details key facts associated with the quarter as named in the company's been subjected to the strategy and any forward statements or guidance, we may make.
Speaker Change: Document is designed to be read by investors or regularly scheduled quarterly conference call as such for this call. We will make brief prepared remarks intrinsic transition into a question and answer session to ensure ample time and opportunity to address everyone's questions. We request you limit yourself to one question and one follow up you still have additional questions you may have.
Christopher Lewis: 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.
Speaker Change: It back into the queue.
Christopher Lewis: Please note that all statements, other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, products, pipeline technologies, and clinical trials, U.S. and international commercialization, market development efforts, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations.
Speaker Change: Please note that all statements other than statements of historical facts made on this call.
Speaker Change: Activities events or developments, we expect believe or anticipate well or may occur in the future are forward looking statements.
Speaker Change: Statements about our plans objectives strategies and prospects regarding among other things our sales products pipeline technologies and clinical trials U S and international commercialization market development efforts, because half of our current and future products competitive market position regulatory strategies and reimbursement for our products.
Speaker Change: Our financial condition and results of operations as well as the expected impact of general macroeconomic conditions.
Speaker Change: Currency fluctuations on our business and operations.
Christopher Lewis: 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 effects. You can also find these documents in the Investor Relations section of our website at www.glaukos.com.
Speaker Change: These statements are based on current expectations about future events affecting us and are.
Speaker Change: 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 Change: These documents on the Investor Relations section of our website at Www Dot Glafkos Dot 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 in the Gulf Coast is ongoing results of operations.
Christopher Lewis: 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 and earnings press release available in the investor list relations section of our website for a reconciliation of these measures to the most directly comparable GAAP financial measure.
Speaker Change: Particularly when comparing underlying results from period to period.
Speaker Change: Please refer to the tables in our earnings press release available on the Investor.
Speaker Change: Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure.
Thomas Burns: With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns. Okay, thank you, Chris. Good afternoon, thank you all for joining us.
Speaker Change: With that I'll turn the call over to Clive <unk>, Chairman and CEO, Tom Burns. Okay. Thank you Chris Good afternoon, and thank you all for joining us.
Thomas Burns: Today Glaukos reported record first quarter consolidated net sales of 106.7 million, 25% on a reported basis or 26% on a constant currency basis versus the year ago quarter.
Speaker Change: Today <unk> reported record first quarter consolidated net sales of $106 7 million.
Speaker Change: 25% on a reported basis or 26% on a constant currency basis versus the year ago quarter.
Thomas Burns: We are also reaffirming our full year 2025 net sales guidance range of $475 to $485 million as we balance our first quarter outperformance while continuing to closely monitor the global macroeconomic environment and associated uncertain Our first quarter record results reflect the sustained growth acceleration in our business with strong performance driven by high-dose TR adoption and both our U.S. and international Glaucoma franchises overall.
Speaker Change: We are also reaffirming our full year 2025, net sales guidance range of 475 to four 5 million as we balance our first quarter outperformance, while continuing to closely monitor the global macro economic environment and associated uncertainties.
Speaker Change: Our first quarter record results reflect the sustaining and growth acceleration in our business with strong performance driven by Idose TR adoption.
Speaker Change: In both our U S and international glaucoma franchises overall.
Thomas Burns: Our continued growth trajectory globally is the result of our ongoing efforts to pioneer and develop the interventional glaucoma, or IG, marketplace with new stand-alone therapies designed to slow disease progression and reduce drug burden for the benefit of physicians and patients. These efforts were on full display at the AGS conference in February, and more recently at the ACRS annual meeting last weekend, where the interest and excitement levels for interventional glaucoma and our technologies were high. 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.
Speaker Change: Our continued growth trajectory globally as a result of our ongoing efforts to pioneer a kebab.
Speaker Change: Interventional glaucoma.
Speaker Change: Marketplace with new Standalone therapies designed to slow disease progression and reduced drug burden for the benefit of physicians and patients.
Speaker Change: These efforts were on full display at the Ats Conference in February and more recently at Eas Crs annual meeting last weekend, where the interest and excitement level sport interventional glaucoma and our technologies were high.
Speaker Change: While we remain in the early stages of these efforts we are encouraged with increasing levels of clinical interest for this paradigm changing evolution.
Thomas Burns: Within our US glaucoma franchise, we delivered record first quarter net sales of 59.1 million on strong year over year growth of 41%. driven by growing contributions from IDOS-TR, a first-of-its-kind intracameral procedural pharmaceutical that was designed to continuously deliver glaucoma drug therapy for up to three years. 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. Operationally, our teams continue to make great progress in the execution of our detailed launch plans for IDOS-TR, including, first, Growing the Universe of Trained Surgeons and Accounts.
Speaker Change: Within our U S. Glaucoma franchise, we delivered record first quarter net sales of $59 1 million on strong year over year growth of 41% driven.
Speaker Change: Driven by growing contributions from Idose TR, a first of its time intra camera procedural pharmaceutical.
Speaker Change: And to continuously deliver glaucoma drug therapy for up to three years.
Speaker Change: Importantly, clinical outcomes and product feedback from a growing number of cases and train surgeons continue to be very positive and reaffirms our view that with the launch.
Speaker Change: <unk>, we are pioneering a brand new therapeutic category.
Speaker Change: Has the potential to reshape glaucoma management as we know it today.
Speaker Change: Operationally our teams continue to make great progress in execution of our detailed launch brands plans for Idose TR, including first.
Speaker Change: Growing the universe of trained surgeons and accounts second expanding utilization of the installed active surgeon base.
Thomas Burns: Second, expanding utilization of the installed active surgeon base. Third, broadening and streamlining market access among MACs, commercial and Medicare Advantage payers.
Speaker Change: Third broadening and streamlining market access among maxx commercial and Medicare advantage payers.
Thomas Burns: 4. Expanding the robust body of clinical evidence, and 5. Accelerating marketing investments to support increased patient awareness and education. Overall, while we remain in the early 80s, I couldn't be more pleased with the strong foundation we built to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension.
Speaker Change: Expanding the robust body of clinical evidence and fifth accelerating marketing investments to support increased patient awareness and education.
Speaker Change: Overall, while we remain in the early eighties I couldnt be more pleased with the strong foundation, we built.
Speaker Change: This transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension.
Thomas Burns: Shifting to our U.S. business, as anticipated, the five Mac LCDs implemented in the fourth quarter of 2024 continue to cause some transient turbulence in the market during the first quarter as surgeons navigate restrictions when using two MIG surgical devices in the same procedure. We expect this MIGS market headwind will continue over the course of 2025 as providers continue to navigate the impacts associated with these LCDs until anniversaries later this year.
Speaker Change: Shifting to our U S business as anticipated with five back Lcd's implemented in the fourth quarter of 2024 continue to cause some trenching turbulence in the market during the first quarter of surgeons to navigate restrictions when using two big surgical devices in the same procedure.
Speaker Change: We expect this makes market headwind will continue over the course of 2025 as providers continue to navigate the impacts associated with these all Cds until it anniversaries later this year.
Thomas Burns: Moving on, our interventional glaucoma franchise also delivered record net sales of $29 million on a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis. The strong growth was once again based as we continue to scale our international infrastructure and execute our plans, drive mixed forward as a standard of care in each region and major market in the world.
Speaker Change: Moving on our intimate interventional glaucoma franchise also delivered record net sales of $29 million.
Speaker Change: Year over year growth of 15% on a reported basis and 19% on a constant currency basis.
Speaker Change: This strong growth was once again broad based as we continued to scale, our international infrastructure and execute our plans drive makes board as the standard of care in each region and major market World.
Thomas Burns: 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 as we progress through 2025.
Speaker Change: We remain in the early stages of expanding our IGN and private portfolio initiatives globally.
Speaker Change: As anticipated new product approvals and expanding market access in the years to come.
Speaker Change: As previously discussed we expect the trialing of new competitive products and some of our major international markets may become an increasing headwind as we progressed through 2025.
Thomas Burns: Finally, our corneal health franchise delivered bed sales of $18.5 million, including for TREXA bed sales of $15.4 million.
Speaker Change: And finally, our corneal health franchise delivered net sales of $18 5 million.
Speaker Change: <unk> net sales of $15 4 million.
Thomas Burns: As discussed throughout 2024, our first quarter results reflect the continuing impact of Fortrexa realized revenues as a result of our entry as a company into the Medicare Drug Relay Program, or MDRP.
Speaker Change: As discussed throughout 2024, our first quarter results reflect the continued impact of <unk> realized revenues as a result of our entry as a company into the Medicare drug rebate program or an empty ERP.
Thomas Burns: Shifting gears to our corneal health pipeline, during the first quarter we announced FDA acceptance for review of the previously submitted NDA for Epioxa, our next generation corneal cross-linking eyelid therapy for the treatment of keratoconus, a rarely diagnosed sight and writing disease. This important milestone brings us one step closer to being able to provide care to corneal epithelium patients in the Apsala community with the first FDA approved non-invasive 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 and their pending review process as we progress toward the agency's established PDUFA date of October 20, 2025.
Speaker Change: Shifting gears to our corneal health pipeline during the first quarter, we announced FDA acceptance for review of the previously submitted NDA for <unk>. Our next generation corneal cross linking <unk> therapy for the treatment of care to Carlos.
Speaker Change: Diagnose sight threatening disease.
Speaker Change: This important milestone brings us one step closer to being able to provide keratoconus patients and they have solid community with the first FDA approved non in basin corneal cross linking drug therapy.
Speaker Change: Now required the removal of the corneal epithelium, the outermost layer of the fund.
Speaker Change: We look forward to working closely with the FDA and their pending review process as we progress towards the agencies established producer date of October 20th 2025.
Thomas Burns: Alongside this, our teams continue to make nice progress with the preparation and planning of the Epioxa commercial launch targeted for next year.
Speaker Change: Alongside this our teams continue to make nice progress with the preparation and planning of the <unk> commercial launch targeted for next year.
Thomas Burns: It is worth reminding investors that an Epioxa approval also provides us with the opportunity to launch this pharmaceutical therapy supported by the right long term pillars to optimize patient access.
Speaker Change: It is worth reminding investors that in FERC approval also provides us with the opportunity to launch this pharmaceutical therapies supported by the right long term pillars to optimize patient access.
Thomas Burns: Persistent and at times a frustrating challenge for us historically with latrexia. We continue to believe that epiaxa, designed to preserve the corneal epithelium, streamline procedure times, improve patient comfort, and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus.
Speaker Change: A persistent and at times, a frustrating challenge for us historically with Rituxan.
Speaker Change: We continue to believe that <unk>.
Speaker Change: Side to preserve the corneal epithelium streamline procedure times improve patient comfort and shorten recovery time represents a potentially meaningful advancement in the treatment paradigm for patients suffering from terror keratoconus.
Thomas Burns: Beyond epiaxial, we're also pleased to share we recently commenced a 510k pivotal study under FDA ID for the pressor flow microshunt, an external system designed to help drain excess fluid from the eye and reduce intraocular pressure in refractory glaucoma patients. Our commercialization efforts of Pressure Flow in Canada, Australia, and several Latin American countries have reaffirmed the strong appetite within the global ophthalmic community for this technology as a more elegant, better tolerated, and external alternative to conventional filtration surgeries for late stage glaucoma management. Additionally, we continue to advance several other important clinical trials. including one PMA-PITL trial for ISIN Infinite mild to moderate glaucoma patients.
Beyond that'd be OXXO were also pleased to share. We recently commenced a 500 10-K pivotal study under FDA I E from the press will flow micro shot.
Speaker Change: <unk> terminal system designed to help train excess fluid from the yard and reduce intraocular pressure and refractory glaucoma patients.
Our commercialization commercialization efforts of pressure flow in Canada, Australia, several Latin American countries have reaffirmed the strong appetite within the global a solid community for this technology as a more elegant better tolerated average turn alternative to conventional filtration surgeries for late stage glaucoma.
Speaker Change: Management.
Speaker Change: Additionally, we continue to advance several other important clinical trials.
Speaker Change: <unk>, one PMA pivotal trial for Istent infinite mild to moderate glaucoma patients.
Thomas Burns: Two, phase two trials for our ILINK third generation therapy. Three, a first in human clinical development for GLK-401, our intravitreal multikinase inhibitor retinal program in wet AMD patients, where we now also have an open US FDA INDE. And four, a phase 2b3 clinical program for I-Dose T-Rex, our next generation I-Dose therapy.
Speaker Change: Two phase III trials for our IL <unk>.
Speaker Change: Third generation therapy, three our first in human clinical development for GL case, 401, our interim interim multi kinase inhibitor rental program in wet AMD patients, where we now also have an open U S. FDA.
Speaker Change: Yeah.
Speaker Change: And for a phase II III clinical program for our Idose T Rex or next generation Idose therapies.
Thomas Burns: Finally, we remain on track to file a U.S. FDA IND immense clinical study for Ilucian devinex blepharitis later this year. As you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. At the same time, as we consistently discuss, we continue to prioritize the cadence of our investment. as we strive to strike the right balance of risk-based investments in our capital position now and in the future.
Speaker Change: Finally, we remain on track to file an U S. FDA <unk> commence clinical studies for evolution debit ex Blepharitis later this year.
Speaker Change: As you can see we have a lot to be excited about with <unk> significant potential value that we believe our pipeline programs may create.
Speaker Change: At the same time as we consistently discussed continue to prioritize the cadence of our investments as we strive to strike the right balance of risk based investments and our capital position now and in the future.
Thomas Burns: To that end, we ended the first quarter of 2025 in a strong capital position with cash equivalents of more than $303 million and no debt. This allowed us to continue to be active on the business development front with a focus on transactions to support our existing organic growth initiatives. One such example of this is our recently announced, expanded collaboration with Radius XR and TopCon Healthcare that enables us to accelerate our global efforts to bring the tools and software solutions needed to democratize the diagnosis of glaucoma, and in turn, create more efficient care networks for patients afflicted with this lifelong Finally, given the ongoing conversations around tariff and geopolitical issues, we wanted to highlight that we manufacture and source our products primarily within the United States.
Speaker Change: To that end, we ended the first quarter of 2025, and strong capital position with cash and equivalents of more than $303 million and no debt.
Speaker Change: So this allowed us to continue to be active on the business development front with a focus on transactions that support our existing organic growth initiatives.
Speaker Change: One such example of this is our recently announced expanded collaboration with radius XR and top down healthcare that enables us to accelerate our global efforts to bring the tools and software solutions needed to democratize, the diagnosis of glaucoma and in turn create more efficient shared networks for patients afflicted with this.
Speaker Change: Slide six.
Speaker Change: Finally, given the ongoing conversations around tariff and geopolitical issues. We wanted to highlight that we manufacture and source our products primarily within the United States.
Thomas Burns: And as such, we expect minimal direct exposure to the most recently implemented tariff-related policies.
Speaker Change: And as such we expect minimal direct exposure to the most recently implemented carefully policies.
Operator: In conclusion, I am very pleased with the record quarter and 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 the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye So with that, I'll open the call for questions. Operator. At this time, if you would like to ask a question, press star followed by the number 1 on your telephone keypad. If your question has been answered, and you would like to remove yourself from the queue, press star followed by the number 1.
Speaker Change: In conclusion I am.
Speaker Change: Very pleased with our record quarter and strong momentum in our business. We continued to successfully advance our mission to truly transform vision by pioneering novel drop those platforms that can meaningfully advance standard of care and improve outcomes for patients suffering from sight threatening chronic eye diseases.
Speaker Change: So with that I'll open the call up for questions operator.
Speaker Change: At this time, if you'd like to ask a question press star followed by the number one on your telephone keypad.
Speaker Change: Your question has been answered and you would like to remove yourself from the queue Press star followed by the number one.
Thomas Stephens: Your first question is from a line of Tom Stephens with Stephen. Great. Hey, guys. Thanks for taking the questions. I guess first to start off, would you be able to provide U.S. stent growth in the corridor? And as a tack onto that, Joe or Tom, maybe if you can talk more about what you're seeing in terms of how doctors are reacting from a share standpoint. to the LCD so far this year and expectations looking ahead for you.
Tom Stephen: First question is from the line of Tom Stephen <unk> with Stifel.
Speaker Change: Yeah.
Speaker Change: Great Hey, guys. Thanks for taking the questions.
Speaker Change: I guess first to start off would you be able to provide U S state growth in the quarter and as a tack onto that.
Speaker Change: Joe or Tom maybe if you can talk more about what youre seeing in terms of how doctors are reacting from a share standpoint for the LCD. So far this year and expectations looking ahead for U S mix. Thanks.
Joseph Gilliam: Hi, Tom. It's Joe.
Speaker Change: Hi, Tom It's Joe I'll start off.
Joseph Gilliam: I'll start off, and then Tom can add any additional color that he might have for conversations he had, including this past weekend at ASCRS. You know, in the first quarter, we really saw the U.S. glaucoma business, you've seen the reported overall, you know, 40-plus percent year-over-year growth and the 5 percent sequential growth. And, you know, as it might be expected, that was entirely driven by the expansion of IDOS, TR, and offset by the impact of these LCD restrictions. They were modestly more pronounced than expected on our STEM franchise, and in total, we saw a mid-single-digit decline year-over-year.
Speaker Change: And then Tom can add any initial color than you might have some conversations yet, including this past weekend at Crs.
Speaker Change: In the first quarter, we really saw.
Speaker Change: The U S glaucoma business, you've seen a reported overall 40 plus percent year over year growth.
Speaker Change: And the 5% sequential growth.
Speaker Change: It might be expected that was entirely driven by the continued expansion of Idose TR and offset by the impact of these LCD restrictions.
Speaker Change: They were modestly more pronounced than expected on our <unk> franchise and in total we saw a mid single digit decline year over year. So we're going to continue to probably forecast that for the foreseeable future here as we continue to navigate.
Joseph Gilliam: So, we're going to continue to probably forecast that for the foreseeable future here as we continue to navigate the, you know, potential impact of those LCD restrictions on our customers. You know, it's somewhat uniquely challenging for us to forecast, given, you know, we estimate that the LCD changes remove 10 to 15 percent of the MIGS volume, if you will, in 2025 when compared to 2024. But for us, that's also somewhat offset by growing standalone utilization of ICE and Infinite and confounded, obviously, by the prioritization elevated associated with IDOS, TR. So, you know, from a macro standpoint, despite the 10 to 15 percent, you know, call it headwind in the combo cataract MIGS, our sense is that we're holding our own, and the fact that we've experienced a mid-single-digit decline the first quarter is probably a relative positive in the context of the overall market dynamics throughout that quarter.
Speaker Change: Potential impact of those LCD restrictions on our customers.
Speaker Change: You know its somewhat uniquely challenging for us to forecast given we estimate that.
Speaker Change: The LCD changes remove 10% to 15%.
Speaker Change: The mix volume if you will in 2025, when compared to 2024, but for US. It's also somewhat offset by growing standalone used let utilization of Istent infinite and confounded, obviously by the prioritization, that's elevated especially with Idose TR.
Speaker Change: From a macro standpoint, despite the 10% to 15% call it headwind in the combo cataract mix.
Speaker Change: Our sense is that we're holding our own in.
Speaker Change: And the fact that we've experienced a mid single digit decline in the first quarter.
Speaker Change: A relative positive in the context of the overall market dynamics throughout that quarter.
Joseph Gilliam: As it relates to doctors, I think it's very specific to their own decisions and algorithms and how they make those selections. Obviously, they're disappointed by the fact that the clinical decision-making has been taken out of their hands and being determined by an insurer, in this case, a medical director or a MAC. But they're navigating that, and perhaps they'll be focused more on a serial approach to the glaucoma care versus trying to do it combinatorially in a single procedure. That makes sense. Really helpful.
Speaker Change: It relates to doctors I think it's very specific to their own decisions and algorithms and.
Speaker Change: And how they make those those selections obviously.
Speaker Change: We're disappointed by the fact that the clinical decision, making has been taken out of out of their hands and being determined by an insurer in this case, a medical director of map.
But they are navigating that and perhaps.
Speaker Change: There'll be focused more on a serial approach to the glaucoma care versus trying to do a competent orally in a single procedure.
Speaker Change: That makes sense really helpful. And then my follow up dividends Idose.
Thomas Stephens: And then my follow-up, pivoting to Eidos, I wanted to ask about Noridian specifically. It's been the most advanced MAC in terms of reimbursement. I think exiting last year, it was the only one with kind of streamlined J-code reimbursement and a professional fee on the fee schedule.
Speaker Change: I wanted to ask about <unk> and specifically it's been the most advanced Mac in terms of reimbursement I think exiting last year. It was the only one with kind of streamlined J code reimbursement and a professional fee on the fee schedule overtime.
Joseph Gilliam: So, Joe or Tom, have you seen or are you seeing any sort of inflection or acceleration in Noridian, you know, again, with reimbursement in a solid place? And then is it fair to view Noridian maybe as sort of an analog for when the rest of the MAC...
Speaker Change: Have you seen or are you seeing any sort of inflection or acceleration in the Iranian again with reimbursement in a solid place and then is it fair to view their radian, maybe thats sort of an analogue for when the rest of the mix come up to speed.
Joseph Gilliam: Yeah, Tom, I think, clearly, Meridian is the first case study that we can, you know, watch, assess, and then extrapolate in terms of what it can mean for the other MACs as they come online. And, in fact, in some ways, what we've been seeing as of late in Novitas and First Coast validates that assumption that the trend lines are somewhat consistent, and the timelines associated with those trend lines are somewhat consistent. You know, sometimes, as these milestones are knocked down or as the adjudication becomes more streamlined, it takes a little bit of time for that to translate both to the sales force, the customer, to their, you know, scheduling and staffing, as well as, ultimately, the procedures attached to it.
Speaker Change: Yeah, Tom I think clearly <unk> is the first case study that we can watch a SaaS.
Speaker Change: Yes, and then extrapolate in terms of what it can mean for.
Speaker Change: The other the other macs as they come online and in fact in some ways, what we've been seeing as of late and nobody talks in first coast validates that assumption that the trend lines.
Speaker Change: Our somewhat consistent and the timelines associated those trend lines are somewhat consistent.
Speaker Change: As these milestones are knocked down or or as the adjudication becomes more streamlined it takes a little bit of time for that to translate both for the sales force the customer to their scheduling and staffing as well as ultimately the procedures attached to it but what we are seeing continued solid and expanding growth.
Joseph Gilliam: But what we are seeing is continued, solid, and expanding growth. You know, you referenced Meridian specifically, given it was there first, and it shouldn't surprise you that, you know, despite being around 20 percent of the covered lives, its percentage of our overall, you know, IGES contribution is something close to double that, given the dynamics at play there.
Speaker Change: You referenced meridian, specifically given it was their first and.
Speaker Change: And it Shouldnt surprise, you that despite being around 20% of the covered lives.
Speaker Change: Percentage of our overall contribution is something close to double that given the dynamics at play there.
Speaker Change: Yeah.
Ryan Zimmerman: Your next question is from the line of Ryan Zimmerman with BTIG. Hey, excuse me. Good afternoon. Thanks for taking our question. You know, last quarter, Joe, you gave some commentary on kind of the components of guidance. from a growth perspective. You know, you've beat now for the, you know, having the first quarter behind you. Guidance is staying the same.
Speaker Change: Your next question is from the line of Ryan Zimmerman with BTG.
Speaker Change: Hey.
Ryan Zimmerman: Excuse me good afternoon, thanks for taking our questions.
Speaker Change: Last quarter, Joe you.
Speaker Change: Gave some commentary on kind of the components of guidance.
Speaker Change: From a growth perspective.
Speaker Change: You beat now for having the first quarter behind you.
Speaker Change: Guidance is staying the same.
Joseph Gilliam: Maybe, you know, be curious to know kind of where you stand on some of those components within your guidance. Obviously, with an emphasis on kind of the STEM versus, you know, iDOS franchises and contributions, or if those still hold, then remind us what those are as we think about guidance.
Speaker Change: Maybe I'd be curious to know kind of where you stand on some of those components within your guidance.
Speaker Change: Obviously with an emphasis on kind of the stand versus.
Speaker Change: Idose franchises and contributions and or if those still hold and remind us what those are.
Speaker Change: Think about guidance.
Joseph Gilliam: Yeah, happy to do that, Ryan. Obviously, the first quarter was strong from a performance perspective with the 25% growth and certainly highlighted about 40% plus growth in the U.S. And as you think about, there are a fair number of, I'll call it adjustments as we make our way through the year in terms of what comprises the overall guidance here. And so, in no particular order, when you think about the corneal health business, we continue to dial in the impact of MDRP on this franchise. And at this point, I think we would probably guide you towards flat to low single-digit growth, clearly ahead of what we expect to be an exciting year in 2026 with the launch of, with Epioxa.
Speaker Change: Yes, happy to do that Bryan Yeah, obviously, the first quarter was strong from a performance perspective, with the 25% growth and certainly highlighted about 40% plus growth in the U S and and as you think about there are a fair number of I'll call. It adjustments as we make our way through the year in terms of what comprises the <unk>.
Speaker Change: Overall guidance here so.
Speaker Change: No particular order when you think about the corneal health business, we continue to dial in the impact of <unk>.
Speaker Change: On this franchise.
Speaker Change: And at this point I think we would probably guide you towards flat to low single digit growth.
Speaker Change: Clearly ahead of what we expect to be an exciting year in 2026 with the launch of would that be OXXO is a small a slight change.
Joseph Gilliam: That's a small, slight change as we've dialed in that. On the international glaucoma front, encouraging start to 2025, you know, continued strong performance around the globe. And so, we'd probably have revised expectations there of, I'll call it high single-digit to low digital double-digit growth year over year as we continue to kind of balance strong performance against the macro uncertainties and the backdrop that all companies are facing. And then in particular, obviously, competitive product launches and key markets and a lapping from that amended French rebating agreement that we talked about in 2024. And that then leads you to U.S.
Speaker Change: As we've done that on the international glaucoma upfront.
Speaker Change: Encouraging start to 2025 continued strong performance around the globe.
Speaker Change: And so we'd probably have revised expectations there of I'll call. It high single digit to low digital double digit growth year over year.
Speaker Change: As we continue to kind of balanced strong performance against the macro uncertainties in the backdrop that all companies are facing and then in particular, obviously competitive product launches in key markets and the lapping from that amended fridge rebate agreements, we talked about 2024.
Speaker Change: That then leaves you the U S glaucoma, where.
Joseph Gilliam: glaucoma, where, you know, I think we now expect that the LCD headwinds consistent with what we saw in the first quarter, and I'll call it the hydrous royalty expiration, to generate a, I'll call it a mid-single-digit decline for non-iDOS revenues in 2025. And when you put all that together, which I'm not expecting you necessarily to do on the fly, Rahed, it's going to imply that we're actually are modestly increasing our iDOS expectations for the remainder of 2025 versus what you probably had or most people had in their models coming into the call. Yeah, no, that makes sense, Joe, and that all tracks.
Speaker Change: <unk>.
Speaker Change: We now expect that the LCD headwinds consistent when we sold the first quarter and I'll call. It the hydrus royalty exploration to generate.
Speaker Change: Call. It a mid single digit decline for non Idose revenues in 2025.
Speaker Change: And when you put all that together, which I'm not expecting necessarily to do on the fly right. It's going to imply that we're actually are.
Speaker Change: Modestly increasing our idose expectations for the remainder of 2025 versus what you're probably had our most people out of their models coming into the call.
Speaker Change: Yes no.
Speaker Change: That makes sense Joe.
Speaker Change: That all tracks with with kind of the numbers.
Ryan Zimmerman: kind of the numbers that I'm getting to.
Speaker Change: Getting to and so the follow up question to that is is around the pacing of idose.
Ryan Zimmerman: And so the follow-up question to that is around the pacing of IDOS. And, and, you know, we saw you this weekend at ASCRS, obviously a lot of focus there on iDOS. How do you think about, I mean, there is a pretty steep ramp implied on your I-dose expectation.
Speaker Change: And and we saw.
Speaker Change: This weekend at Ash, Sierra So obviously a lot of focus there on idose.
Speaker Change: How do you think about I mean, there is at a pretty steep.
Speaker Change: Ram implied on your Idose expectations this year.
Joseph Gilliam: And some of that is from, you know, kind of Mac's coming on board and so forth, but just talk us through kind of what's underpinning those assumptions to get from where we think you did today, and I, by my math, about $21 million and change this quarter to what arguably is almost double that by the Yeah, sure. I mean, in some ways, also, as you know, Ryan, it's not significant change in volumes that drive those numbers. Obviously, it's a doubling in volume, but at the end that we're at right now, modest changes in your assumptions can drive those types of results in your model, in your forecast.
Speaker Change: And some of that is from kind of Max coming on board and so forth, but just talk us through kind of what's underpinning those assumptions.
Speaker Change: <unk> from where we think you did today.
Speaker Change: By my math about $21 million and change this quarter to what arguably is.
Speaker Change: Most double that by.
Speaker Change: The fourth quarter.
Speaker Change: Yes sure.
Speaker Change: <unk> also as you know Ryan it's not significant change in volumes to drive those those those numbers, obviously, the doubling in volume, but at the end that we're at right now.
Speaker Change: Modest changes in your assumptions can drive those those types of results.
Speaker Change: In your model and Youre in your forecast, but look I think for us.
Joseph Gilliam: But look, I think for us, you know, underlying where we sit today is obviously the month-to-month continued progress that we've been making, including the progress we made from February into March and March into April sitting here today. And if you think about what you're talking about is using the number you gave at $21 million, you're already at an $85 million run rate exiting the first quarter. And as you know, March was probably the largest contributor of that. So, as we move forward, I think we've got good momentum to continue to achieve the ITOS expectations that are underneath our guidance.
Speaker Change: Underlying where we sit today is obviously the month to month continued progress that we've been making.
Speaker Change: Including the progress we made from February to March and March into April sitting here today, and if you think about what you are talking about is using your the number you gave of $21 million were already at $85 million run rate exiting the first quarter and and as you know March was probably the largest contributor of that so as we move forward I think.
Speaker Change: We've got good momentum to continue to achieve the idose expectations that our needs our guidance.
Joseph Gilliam: And maybe more specifically, you know, just thinking about the Medicare, you know, fee-for-service patient population, you know, Tom asked about Noridian. But clearly, we also are in the middle right now of turning on Novus Ops and First Coast. I would say that in recent weeks, they've really joined the operating as expected group, which previously would have only had Noridian in it. And it took some time after the PRO-P schedule was established and published to reach that status. And at the same time, you know, Palmetto and WPS today largely appear to be paying the J code correctly.
And maybe more specifically.
Speaker Change: Just thinking about the Medicare.
Speaker Change: Fee for service patient population.
Tom: Tom asked about Meridian.
Tom: Clearly we also are in the middle right now of turning on <unk> and first coast I would say that.
Tom: In recent weeks, they've really joined.
Tom: Operating as expected group, which previously would have only had meridian in it.
Tom: And it took some time after the appropriate schedule was established and published to reset status and.
Tom: And at the same time.
Tom: <unk> in WPS today, largely appear to be paying the J code correctly.
Joseph Gilliam: And in our attention and efforts in those MACs have started to shift to achieving more consistent professional fees. And even CGS and NGS have been showing early signs of JCOE consistency. So I'm not quite ready to put them in alongside Palmetto and WPS. There are signs for optimism there.
Tom: And our attention and efforts in those Max have started shifting to achieving more consistent professional fees and.
Tom: And even CGS and Ngls have been showing early signs of Jacob consistency, So I am not quite ready to put them alongside palmetto in WPS there are signs for optimism there.
Joseph Gilliam: The translation of which, in each one of those things, does not necessarily mean that any one point in time, any one quarter, including second quarter, is where you're going to see some pop, but I do believe that overall, it's a consistent upward progress on market access and, in turn, the commercial results that come downstream of that.
Tom: The translation of which in each one of those things does not necessarily mean that any one point in time, any one quarter and couldnt say quarters, where youre going to see some pop, but I do believe that overall, it's a consistent.
Tom: Upward.
Tom: Progress on market access and in turn the commercial results to come downstream of that.
Lawrence Biegelsen: Your next question is from the line of Larry Biegelsen, Wells Fargo. Good afternoon. Thanks for taking the question. I guess, Joe, on iDOS, the question I have is, you know, have things played out according to your expectations on the reimbursement side? Has it taken longer? And, you know, obviously, I guess, are you still, you know, would you consider changing the price? I mean, obviously, the price came out higher than people expected. You know, how much of an impediment is that? And would you consider an LCD to unlock Medicare Advantage?
Larry Nicholson: Your next question is from the line of Larry Nicholson with Wells Fargo.
Larry Nicholson: Hi, good afternoon, and thanks for taking the question.
Larry Nicholson: I guess, Joe on Idose. The question I have is you don't have things played out according to your expectations.
Larry Nicholson: On the reimbursement side as it has it taken longer.
Larry Nicholson: And.
Larry Nicholson: Obviously, I guess are you still would you consider changing the price I mean, obviously the price came out higher than people expected how much of an impediment as that and would you consider an LCD to unlock Medicare advantage.
Joseph Gilliam: So, a fair amount there, Larry. Let me first say that as it relates to EIDOS and our internal expectations, both for 2024 as well as in the first quarter of 2025, the results have exceeded what our forecasting expectations were from an analytical perspective. As it relates to market access, you know, that's a harder one to answer because while it may have aligned with some ways with what we had, you know, forecasted that underpinned our models, you always want to move faster and you always want to see streamlined adjudication quicker, whether it's on the drug side or on the professional fee side, because you know downstream of that, you know, patients aren't getting access to your technology and your therapy that deserve it until you've got those things streamlined.
Larry Nicholson: So.
Speaker Change: A fair amount there Larry let me first say that as it relates to Idose and our internal expectations. Both for 2024 as well as in the first quarter of 2005. The result of exceeded what our forecasting expectations were from an analytical perspective.
As it relates to market access.
Speaker Change: Harder one to answer because while it may have aligned with some ways with what we had forecasted that underpinned our models.
Speaker Change: You always want to move faster and you always want to see streamlined adjudication quicker, whether it's on the drug side or on the professional fee side, because you know downstream of that patients are getting access to your technology your therapy that deserve it until you've got those things streamline so we've been operating as an organization.
Joseph Gilliam: So, we've been operating as an organization with a high degree of urgency quartered and quartered out on working through the adjudication and getting this to a place where it's more streamlined like it is now in Meridian, Novitas and First Coast. I think that it's a misconception to think that price is the element driving the pacing of these, you know, coverage and the streamlined education. It's a process that every company goes through when they have a newly established T-code, or in this case T-code and J-code, to drive the volumes that are required for these Macs to both understand the underlying procedure, quantify or value that, and then feel confident enough to put it in their systems as such.
Speaker Change: With a high degree of urgency.
Speaker Change: And quarter out on working through the adjudication.
Speaker Change: And in getting this to a place where it's more stream like it like it is now in Iridium <unk> and first coast.
Speaker Change: I don't I think that it's a <unk>.
Speaker Change: Misconception to think that.
Speaker Change: Price is the element driving the pacing of these.
Speaker Change: Coverage and the streamline adjudication.
Speaker Change: It's a process that every company goes through when they have a newly established T code or in this case C code and J code to drive the volumes that are required for these macs to both understand the underlying procedure quantify or value that and then feel confident on to put it and confident enough to put it in their systems.
Speaker Change: As such and so from our standpoint, I think maybe the only thing that impacted that from a price standpoint is that it's obviously a little bigger leap for the customers in the early days, but but certainly well worth that squeeze if you will downstream as you get into the place like we are with both Meridian <unk> Ed.
Joseph Gilliam: And so from our standpoint, I think maybe the only thing that impacted that from a price standpoint is that it's obviously a little bigger leap for the customers in the early days, but certainly well worth that squeeze, if you will, downstream as you get into the place like we are with both Meridian, Novitas, and First Coast today.
Speaker Change: First coast today.
Joseph Gilliam: I think as an LCD matter, we've seen the downsides when others have pursued LCD, you know, dynamics in and around this, and so I don't know that's the first place we would go to try to drive more streamlined adjudication. Ultimately, the Medicare Advantage policies, we have pretty significant coverage today along the similar lines of what Dorista has as the other procedural pharmaceutical, and so we would expect it to go down that path moving forward here in a very similar way and continue to open up those access for those patients. I don't think we need an LCD to accomplish that.
Speaker Change: I think given as an LCD matter.
Speaker Change: We've seen the downsides when others have had.
Speaker Change: Pursued.
Speaker Change: LCD dynamics in and around this and so I don't I don't know Thats. The first place we would go to try to drive more streamlined adjudication ultimately the Medicare advantage policies, we have pretty significant coverage today.
Speaker Change: Along the similar lines of what Arista has as the other procedural pharmaceutical and so we would expect it to go down that path moving forward here in a very similar way and to continue to open up those.
Speaker Change: To access those patients I don't think we need an LCD to accomplish that.
Lawrence Biegelsen: All right. I'll leave it there. Thanks for taking the question, guys.
Speaker Change: All right I'll leave it there thanks for taking the question guys.
Alan Gong: Your next question is from the line of Alan Gong with J.P. Morgan. Thanks for the question. You know, kind of piggybacking off of the tariff commentary that you provided, you know, I think one of the concerns is that, you know, as we move into the back half of the year with kind of pretty uncertain macro backdrop, which country companies might be, you know, more or less exposed to an economic slowdown, and potentially kind of like, you know, lower procedure volumes. So I guess just from your point of view, when we think about I stand, and I dose if there is a, you know, economic slowdown, how exposed do you think you are to those Yeah, I think it's something we factored in in our decision to leave guidance where it's at.
Speaker Change: Your next question is from the line of Allen Gong.
Speaker Change: J P Morgan.
Speaker Change: Thanks for the question kind of piggybacking off.
Speaker Change: The tariff commentary that you provided I think one of the concerns is that you know.
Speaker Change: As we move into the back half of the year with kind of.
Speaker Change: Pretty uncertain macro backdrop, which country accompanies might be more or less exposed to an economic slowdown and potentially kind of like lower procedure volumes. So I guess just from your point of view when we think about ice stand and Idose. If there is a.
Speaker Change: Unmik slowdown how exposed you think you are to those kinds of dynamics.
Yes, I think that's something we factored in in our decision to leave guidance, where it squares that it may have been.
Joseph Gilliam: It may have been, you know, in some ways, one of the most significant contributors to our decision to sit tight on guidance here at the beginning of the year. And it's hard, you know, Alan, to point to a specific cause and effect when it comes to things like, you know, macroeconomic policy and the various places that can rear its ugly head. For us, in general, ophthalmology, it follows the areas of health care that are a little bit more insulated. It's certainly the kind of procedures that are associated with glaucoma care, where they're not elective as much in nature.
Speaker Change: In some ways the one of the more significant contributors to our decision to sit tight on guidance here at the beginning of the year.
Speaker Change: And it's hard to point to a specific cause and effect when it comes to things like macroeconomic policy in the various places that reared its ugly head.
Speaker Change: For us in general.
Speaker Change: <unk>. It follows the areas of health care that are that are a little bit more insulated certainly that kind of procedures that are associated with glaucoma care where.
Speaker Change: They are not elective as much in nature.
Joseph Gilliam: But anytime you see pressure on the economy at large, you can see, you know, if rates rise and people are having a harder time getting, you know, access to lines of credits or, in general, running their business, you can have impact as surgery centers or customer offices or different things struggle to make their way through an economic downturn. And so I think it behooves all of us to stay a little bit cautious around, you know, the next, you know, 6, 9, 12 months as we play our way through this tariff situation, what it could mean for the economy overall.
Speaker Change: But anytime you see pressure on the economy at large you can see.
Speaker Change: If rates rise and people are having a harder time getting access to lines of credits or in general running their business you can have impact as surgery centers or customer offices are different things.
Speaker Change: <unk> to make their way through and economic.
Speaker Change: Economic downturn.
Speaker Change: So I think it behooves all of us to stay a little bit cautious around the next <unk>.
Speaker Change: Nine to 12 months as we play out through the players are waiting through this tariff situation what it could mean for the economy overall.
Alan Gong: Got it. Thank you.
Speaker Change: Got it thank you.
Speaker Change: Yeah.
David Saxon: Your next question is from the line of David Saxon. Oh, great.
Speaker Change: Your next question is from the line of David Saxon with name.
David Saxon: Oh, great. Good afternoon. Thanks for taking my questions, maybe I'll do a couple on I do so.
David Saxon: Good afternoon. Thanks for taking my questions. Maybe I'll do a couple on EIDO. So, specifically on reimbursement, it looks like some of the EIDO's kind of pamphlets or guides that you have posted, it looks like it includes like MedAdvantage and commercial. So, I wanted to ask on commercial coverage, like how broad is that coverage from a Covered Lives perspective? What are you seeing in terms of dollar reimbursement versus what the MACs are doing? And then, you know, I don't know if you can name like the major payers, commercial payers that are most consistent.
David Saxon: On specifically on reimbursement and it looks like some of the Idose.
David Saxon: Kind of a pamphlet or guide that you have posted it looks like it includes like med advantage and commercial so I wanted to ask on commercial coverage like how broad is that coverage from our covered lives perspective, what are you seeing in terms of dollar reimbursement versus what the Max are doing and then.
David Saxon: I don't know if you can name like the major payers commercial payers that are most consistent.
David Saxon: Yeah, David, obviously, I would say first, maybe from a macro standpoint, given the progress we're making with Medicare, we have started to move forward selectively in providing, I'll call it customer patient access into the commercial Medicare Advantage arena. We signaled that was part of our plan, and that's something that we very slowly and methodically began to roll out over the course of really exiting the first quarter into the second, and I would expect us to continue to be equally as methodical as we move forward here, primarily because you want to ensure that your customers have the right experience, the right tools to navigate this more tricky payer landscape successfully.
David Saxon: Yes, David.
David Saxon: Obviously, I would say first maybe from a macro standpoint, given the progress we're making with Medicare we have started to move forward selectively.
David Saxon: Providing I'll call it customer patient access in the commercial and Medicare advantage.
David Saxon: Arena.
David Saxon: Signaled that was part of our plan and Thats something that we very slowly and methodically began to rollout over the course of.
David Saxon: Really exited in the first quarter into the second I would expect us to continue to be equally as methodical as we move forward here, primarily because we want to ensure that your customers have the writing experienced the right tools.
David Saxon: To navigate this more tricky payer landscape successful.
David Saxon: But behind the scenes our payer relations team.
David Saxon: Others have been hard at work since really the the date of approval.
David Saxon: And so on both the commercial as well as the Medicare advantage side.
David Saxon: You see coverage policies that extend out over more than 50% of the potential patient population that are covered by those respective areas and with the rest you almost universally C policy silence and so from our standpoint, where the process now of knocking down that same claims.
Joseph Gilliam: And with the rest, you almost universally see policy silence, and so from our standpoint, we're in the process now of knocking down that same claims adjudication, doing the prior offs, and getting comfortable that it's working the way it's supposed to, and we've had some good early success in seeing claims go through with payers as large as United and as small as some of the more regional plans that are out there. So I think we're in a pretty good spot, and from a setup standpoint there, it really is much more down to methodical execution and making sure that those customers are doing it the right way in a way that's successful for their practice while they provide access to those patients for IDOS.
David Saxon: <unk> doing the prior loss.
David Saxon: And getting comfortable that it's working the way, it's supposed to and and we've had some good early success.
David Saxon: Seeing claims go through with payers as large as United and as small as some of the more regional plans that are out there. So I think we're at a pretty good spot from a from a setup standpoint, there. It really is much for down too methodical execution and making sure that those customers are doing it the right way in a way it is successful.
David Saxon: For their practice, while they provide access to those patients.
Speaker Change: Our items.
David Saxon: Okay, great. That was super helpful. Thanks for that.
Speaker Change: Okay, Great that was super helpful. Thanks for that and then in the script you talked about.
David Saxon: And then in the script, you talked about, you know, expanding the IDOS launch. Some of that includes training. So I wanted to ask, like, if you could give an update on the percent of kind of your core ISTAN accounts that you've trained on IDOS, you know, where is the level of demand among doctors for training versus kind of the capacity of the Salesforce to actually do the training? Thanks so much. Yeah, David, I think it's an important point. We've said it before, but I'll reiterate it here. I don't think that the clinical training, if you will, the OR training, the dry labs, the initial procedures, is in any way the gating item from a capacity standpoint on our sales force, nor from a, you know, demand perspective on behalf of the doctors.
Speaker Change: Expanding the Idose launch some of that includes training. So I wanted to ask if you could give an update on the percent of kind of your core ice Dan accounts that you've trained on idose.
Speaker Change: There is the level of demand among doctors for training versus kind of the capacity of the sales force to actually do the training. Thanks, so much.
Speaker Change: Yes, David I think its important point, we've said it before but I'll reiterate here I don't think that the clinical training. If you will the or training the dry labs. The initial procedures is in any way the gating item.
Speaker Change: From a capacity standpoint on our sales force nor from a.
Speaker Change: Demand perspective on behalf of the doctors there are plenty of surgeons every day to continue to want to be trained and at idose into their toolkit and our sales force is more than capable of meeting that demand I think to answer of your first.
David Saxon: There are plenty of surgeons every day who continue to want to be trained and add IDOS into their toolkit, and our sales force is more than capable of meeting that demand. I think, to the answer of your first question, the more time-consuming and important aspect of all that is making sure that the entire office that surrounds that physician or that surgery center are good at adjudicating and processing and following up on the claims that they submit around the product. And as they get better at that, then you start to see the doctor being able to do what they want to do clinically.
Speaker Change: It should.
Speaker Change: The more time consuming and important aspect of all of that is making sure that the entire office that surrounds that position or that surgery center or.
Speaker Change: Good at <unk>.
Speaker Change: Adjudicating and processing and in following up on the claims that they submit around the product and as they get better at that then you start to see the doctor being able to do what they want to do clinically.
David Saxon: And that's when we start to have some fun in an account in terms of where IDOS can go.
Speaker Change: And Thats when we start to have some some funding into account in terms of where Idose can go.
Adam Mader: Your next question is from the line of Adam Mader with Piper Sablin.
Speaker Change: Your next question is from the line of Adam Maeder with Piper Sandler.
Adam Mader: Good afternoon. Thank you for taking the questions. Two from me. The first one is on IDOS re-implantation. I just wanted to see if there was any update there. I think you were planning to make a post-approval supplement submission to FDA in the first half of the year. So, any updates on the progress you're making with FDA? And how quickly do you expect to know, I guess, you know, kind of one way or the other, and then add a follow-up?
Adam Maeder: Good afternoon, and thank you for taking the questions.
Adam Maeder: Two from me. The first one is on Idose Reimplantation I just wanted to see if there was any update there I think you were planning to make a post approval supplement submission to <unk>.
Speaker Change: <unk> in the first half of the year so.
Adam Maeder: Any updates.
Adam Maeder: On the progress Youre, making with FDA and how quickly do you expect to know I guess kind of one way or the other and then had a follow up thanks.
Thomas Burns: And I'm happy to take this question. So yes, we talked about filing the post-approval NDA supplement in the first half. We've actually done so in the first quarter. So we've beaten that timeline. It's now with the FDA. The FDA has a six-month statutory obligation to get back to us. And so we expect to be able to hear results of their adjudication by year-end. That's really helpful. Appreciate the color there, Tom.
Adam Maeder: And I'm happy to take this question. So yes, we talked about filing the post approval NDA supplement in the first half with taxi done so in the first quarter. So we can beat that timeline. It is now with the FDA and the FDA has six months statutory obligation to get back to us.
Adam Maeder: So we expect to be able to hear results of their adjudication by year end.
Adam Maeder: That's really helpful. I appreciate the color there Tom.
Adam Mader: And one maybe for Joe or Alex, you know, I know you guys don't give quarterly guidance, but you did give some helpful color on the last earnings call around kind of sequencing of models. So I wanted to see if there's any updated thoughts in terms of kind of how you see the rest of the year playing out on the top line and specifically wondering if you had any kind of reaction, comment as it relates to Q2 revenue. I show consensus at $116 million and Q2 IDOS revenue at $25 million. Just any comment on where those figures stand.
Adam Maeder: And one maybe for Gellar Alex.
Speaker Change: I know you guys don't give quarterly guidance, but you did give some helpful color on the last earnings call around kind of sequencing of models.
Speaker Change: So wanted to see if there's any updated thoughts in terms of kind of how you see the the rest of the year playing out in the top line and specifically wondering if you had any kind of reaction comment as it relates to Q2 revenue I showed consensus at $116 million in Q2, Idose revenue at $25 million, just any comment on when adjusting your Sam Thank you.
Joseph Gilliam: Thank you. Yeah, happy to, Adam. I think, as you know, from a seasonality perspective, ophthalmology tends to be, you know, 23-24% in the first quarter, 24-25% in the second, and similar in the third, maybe down a touch. And then the remainder, you know, anywhere from 27 to as much as 29-30% in the fourth. Obviously, ours gets up into it a little bit because of the launch dynamics with IDOS. And sitting here today, I would probably point you to something, you know, obviously the first quarter represents about 22% of the midpoint of our guidance, and the second quarter will probably be somewhere in the 23-24% neighborhood, followed by 24-25% in the third, and call it 28-30% in the fourth quarter.
Speaker Change: Yes, happy to Adam I think as you know.
Speaker Change: From a seasonality perspective ophthalmology tends to be.
Speaker Change: $23, 24% in the first quarter.
Speaker Change: 24, 25% in the second and similar in the third maybe down a touch and then the remainder anywhere from 27 to as much as 30% in the fourth obviously ours gets gets up into it a little bit because of the launch dynamics with idose.
Sitting here today, I would probably point you to something obviously, the first quarter represents about 22% of the midpoint of our guidance and.
Speaker Change: The second quarter will probably be somewhere in the 'twenty three 'twenty, 4% neighborhood, followed by 24% to 25% in the third and call it 20% to 30%.
Speaker Change: In the fourth quarter and again, the exact pacing and sequencing of Idose is going to be the key determinant of that on.
Joseph Gilliam: And again, the exact pacing and sequencing of IDOS is going to be the key determinant of that on top of what is the underlying seasonality.
Speaker Change: On top of what is the underlying seasonality.
Joanne Wuensch: Your next question is from the line of Joanne Wuensch with Citibank. Thank you so much for taking the question. And you actually set it up great. So the quarterly pace for the remainder of the year, I think if I back into the guidance commentary, you raised maybe the IDOS guidance by about 5 million. Could you confirm if that's correct? And also, how do you think about the ramp over the subsequent quarter? Yeah, Joanne, I think what I'd probably say is, I won't get that specific, but clearly I said we raised, you know, underlying and impliedness is a modest raise to the I-DOS expectations.
Speaker Change: Your next question is from the line of Joanne <unk> with Citibank.
Joanne: Thank you so much for taking the question and you actually set up great.
Speaker Change: So the quarterly pace for the remainder of the year I think if I back into the guidance commentary you raised maybe the idose guidance by about 5 million could you confirm if that's correct and also how do you think about the ramp up over the subsequent quarters.
Joanne: Okay.
Joanne: Yes, Joanne I think what I'd, probably say is.
Joanne: We will get that specific but clearly I said, we raised underlying an implied this is a modest raise that to the idose expectations and clearly we expect.
Joseph Gilliam: And clearly we expect, you know, from, you know, month to month and quarter to quarter to continue to see the progress. I think when you unpack some of the earlier guidance that I gave and some of the commentary around the various parts of our business, cornea, interventional, dispense, et cetera, and the seasonality, you'll get pretty close to where you need to be from a basic standpoint. Thank you.
Joanne: From month to month and quarter to quarter to continue to see the progress I think when you unpack some of the earlier guidance that I gave in some of the commentary around the various parts of our business cornea interventional dispense etcetera, and the seasonality youll, you'll get pretty close to where you need to be from a pacing standpoint.
Joanne: Thank you.
Lina Margaret Andrews: Your next question is from Lina Margaret Andrews with William Blair. Hey, good afternoon, guys. Thanks for taking the questions.
Speaker Change: Your next question is from the line of Margaret Andrew with William Blair.
Speaker Change: Hey, good afternoon, guys. Thanks for taking the questions two both around the stem side of the business. So.
Lina Margaret Andrews: Two, both around the STEM side of the business. So, you know, we were at ASCRS, we did see some data kind of around the benefits of combo procedures for patients. I guess, what do you guys think of these data sets? Are they incremental? Are they more meaningful? You know, can they have an impact on the current LCD? Or what steps, I guess, is the industry taking to potentially overturn it in timing? I think from a macro standpoint, you ultimately have to combat that with evidence, right? And so growing evidence, you referenced some, Margaret, around studies that are done by individual practices, groups of practices, manufacturers like Glaukos, you know, ultimately are what help overturn, if you will, restrictions on clinical decision making, which is what you saw with the LCD in November.
Speaker Change: Yeah, we were in a S. Crs are we did see some data kind of around the benefits of combo procedures for patients I guess, what do you guys think of these datasets are they incremental are they more meaningful can have an impact on the current LCD or whats I guess since the industry, taking potentially overturned and timing of that.
Speaker Change: I think from a macro standpoint.
Speaker Change: You ultimately have to combat that with evidence right and so growing evidence you referenced some margaret around.
Speaker Change: Studies that are done by individual practices groups of practices.
Speaker Change: Manufacturers like like cloud Kos ultimately are what help.
Speaker Change: Overturned if you will restrictions on on clinical decision, making which is what you saw with the LCD in November so I.
Joseph Gilliam: So I, you know, I think you'd expect to see more of that from us and from others and from practitioners themselves, because we all know that clinically, it makes sense to attack this progressive disease from multiple angles. And so shame on us if we're not generating the evidence to support that. And I would just add on that, you know, about it. We have been in the driver's seat on combination therapy for some time in multiple modalities.
Speaker Change: I think you should expect to see more of that.
Speaker Change: From us and from others and from practitioners themselves.
Speaker Change: Because we all know that clinically it makes sense to attack this progressive disease from multiple angles.
Speaker Change: And so shame on us if we're not generate the evidence to support that.
Speaker Change: And I would just add on that if you think about it.
Speaker Change: We have been in the driver's seat combination therapy for some time in multiple modalities and I think many of you are aware that we're already.
Joseph Gilliam: And I think many of you are aware that we're already have completed a phase four clinical style, or trial that compares the ICIN Infinite plus IDOS versus Infinite And our hope and expectation is that study will be able to generate data that will not only convince the operating clinician to go to a place where they already want to go, which is to combine two different modalities, to be able to lower target pressures with a single procedure, but also be able to actively support any MAC commercial or Medicare Advantage adjudication in the future. So we try to be prescient in doing these studies well in advance of the market trends that we see that are developing in front of us.
We have completed a phase four clinical staff our trial that compares.
Speaker Change: The Istent infinite plus idose versus internet.
Speaker Change: And our hope and expectation is that study, we will be able to generate data that will not only convince the operating clinician to go to a place where they already want to go which is to combine two different modalities to be able to lower target pressures with a single procedure.
Speaker Change: But also be able to support actively support any back commercial.
Speaker Change: Our Medicare advantage communication in the future so.
Speaker Change: We've tried to be prescient and doing these studies well in advance of the market trends that we see that are developing in front of us.
Lina Margaret Andrews: Okay, that's helpful. Thank you.
Speaker Change: Okay. That's helpful. Thank you and then just you know as we look at guidance on state growth in policies is if you sort of referenced that I'm going to try to get a finer point on it.
Lina Margaret Andrews: And then just, you know, as we look at guidance on stent growth, and apologies if you sort of referenced it, but I'm going to try to get a finer point on it. The stent growth, I think you previously guided to for U.S. kind of flat to down, low single digits. Is guidance now more solidly kind of in that down low single digit range for U.S. stents and anything that we should think about from a comp perspective throughout the year for that specific? Yeah, Morgan, I did allude to it, but I'll put a finer point on it.
Speaker Change: The stunt growth I think you've previously guided to for you asked kind of flat to down low single digits as guidance now more solidly kind of in that download download single digit range for U S sense and anything that we should think about from a comp perspective throughout the year for that specifically.
Speaker Change: Yes, Margaret I did allude to it but I'll put a finer point on it.
Joseph Gilliam: The underlying expectation or guidance right now is that for the non-ITOS business, obviously the vast majority of which is stents, that that will be down mid-single digits for 2025. That's based upon, you know, what we saw in the first quarter and a continuation of that trend. And again, the puts and the takes around that are obviously the restriction impacts in combination with cataract surgery, which are partially offset in our case by continued growth in the standalone side of our stent business. But net-net, we expect the non-ITOS revenues in the U.S. to be down mid-single digit.
Speaker Change: The underlying expectation our guidance right now is that for the non Idose business. Obviously, the vast majority of what's your sense that that will be down mid single digits for 2025 is based upon what we saw.
Speaker Change: In the first quarter.
Speaker Change: Any continuation of that trend in the again, the puts and takes around that or obviously the restriction impacts in combination with cataract surgery.
Speaker Change: Which are partially offset in our case by continued growth in the standalone side of our of our stent business, but but net net we expect the non <unk> revenues in the U S to be down mid single digit Greenway fund.
Richard Newitter: Your next question is from the line of Richard Newitter with Truist Security. All right, thanks for taking the questions. Can you elaborate a little bit on what assumptions you have for the remainder of the year with respect to your slightly higher I-dose guide? With respect to kind of what needs to be in place for, you know, additional profit coverage. or can you more or less get to the numbers that you have with the level of reimbursement that you have now and just physicians getting more comfortable going forward? I'm just trying to get a sense for kind of what needs to happen to get to the high-dose numbers in your model.
Speaker Change: Your next question is from the line of Richard Neuner literally securities.
Richard Neuner: Hi, Thanks for taking the questions.
Richard Neuner: Can you elaborate a little bit on what.
Richard Neuner: Assumptions you have for the remainder of the year with respect to your slightly higher Idose guide.
Richard Neuner: With respect to kind of what needs to be in play for.
Richard Neuner: Additional propane coverage.
Richard Neuner: Or can you can you more or less get to the numbers that you have with.
Richard Neuner: The level of reimbursement that you have now and just the physician getting more comfortable going forward I'm, just trying to get a sense for kind of what what needs to happen to get to the idose numbers in your in your model.
Joseph Gilliam: Yeah, well, maybe I'll look at it a little bit in the way it was asked earlier. So, you know, I think the number that was thrown out was $21 million for the first quarter. So, if you annualize that, you're talking about an $85 million run rate based upon the conditions that existed in the first quarter. Those conditions were obviously a solid pair, if you will, in the median. An emerging pair in Novatops and First Coast that really started to turn on more towards the latter part of the quarter entering into the second. And increasingly improved, if you will, adjudication of claims at WPS, Palmetto, and then later on NGS and CGS.
Richard Neuner: Yeah, well, maybe I'll look into it a little bit.
Richard Neuner: And the way it was asked earlier so.
Richard Neuner: If.
Richard Neuner: I think the number that was thrown out was $21 million for the first quarter. So if you annualize that you are talking about an $85 million run rate based upon the conditions that existed in the first quarter. Those conditions were obviously, a solid payer if you will and meridian.
Richard Neuner: And emerging payer and no no <unk> and first coast. It really started to turn on more towards the latter part of the quarter entering into the second.
Richard Neuner: And.
Richard Neuner: Increasingly improved if you will adjudication of claims at WPS Palmetto and then later on in GFS and CGS.
Joseph Gilliam: So underneath our assumptions is that that trend line continues where first they become all streamlined over the next stretch of time for the J code and the facility. And then usually at some point thereafter the volumes ultimately drive professional fee schedule. And, you know, in addition to that, as I mentioned, we're going to be slowly methodically rolling out commercial Medicare Advantage. There are a lot of drivers there that can drive varying outcomes, some of which are obviously more positive than our guidance and some of which are not. I think we've tried to be, I'll call it the wide part of the bell curve, if you will, in the various scenarios in setting the guidance that we have and what that implies for IDOS.
Richard Neuner: So underneath our assumptions is that that trend line continues where.
Richard Neuner: First they become.
Richard Neuner: All streamlined over the next stretch of time.
Richard Neuner: <unk>.
Richard Neuner: For the J code and the facility.
Richard Neuner: And then usually at some point thereafter, the volumes ultimately drive professional fee schedules.
Richard Neuner: And.
Richard Neuner: In addition to that as I mentioned, we're going to be slowly methodically rolling out commercial Medicare advantage.
Richard Neuner: There are a lot of drivers there that can drive.
Richard Neuner: <unk> outcomes.
Richard Neuner: Some of which are obviously more positive than our guidance and some of which are our non I think we've tried to be.
Richard Neuner: I'll call it the.
Richard Neuner: The wide part of the Bell curve, if you will and the various scenarios in setting the guidance that we have and what that implies for items for the year.
Joseph Gilliam: Got it. And if I could just one more, on the combo MIGS within a combo cataract, doing more than one MIGS, is eidos getting implanted with a MIGS or in concert with a goniotomy? Is that included in kind of the LCD change? Or is eidos actually able to get implanted on a stacked basis?
Richard Neuner: Got it and then if I can just one more on the combo Meg within a combo cataract doing more than one Meg and idose getting implanted with a migs or <unk> and.
Richard Neuner: In concert with Goniotomy.
Richard Neuner: Is that included in kind of the LCD change or.
Richard Neuner: Idaho is actually able to get implanted on a stacked basis.
Joseph Gilliam: I-doses nor are any procedural pharmaceuticals a part of the LCDs that were published in November and so the decisions associated with combinatorial use of that are entirely in the hands of the physicians that use the product.
Richard Neuner: Yes, I doses, nor are any procedural pharmaceuticals are part of the LCD that were published in November and so the decisions associated with combinatorial use of that are entirely in the hands of the physicians that use the product.
Michael Sarcone: Your next question is from the line of Michael Sarcone with Jef...
Speaker Change: Your next question is from the line of Michael Sarcone with Jefferies.
Michael Sarcone: Good afternoon, and thanks for taking our questions. Just to start, maybe following up on Richard's question, I believe last quarter you had mentioned maybe there's just some slight benefit from commercial coverage wins baked into your expectations for IDOS this year. Do you think you can comment on whether or not there have been any changes in kind of the mix of what's baked in for IDOS between traditional Medicare and commercial? I don't think our commentary, Michael, has really changed in the context of the commercial and Medicare Advantage dynamics as it relates to 2025. What we've tried to say last quarter, as well as this one, is that we're going to be very methodical in rolling this out.
Michael Sarcone: Good afternoon, and thanks for taking our questions.
Speaker Change: Just to start.
Speaker Change: Maybe following up on Rich's question.
Speaker Change: Believe last quarter, you had mentioned and maybe there is just some slight benefit from commercial coverage wins baked into your expectations for Idose. This year do you think you can comment on whether or not there have been any changes in kind of the mix of what's baked in for idose between traditional Medicare and commercial.
Speaker Change: I don't think our commentary Michael has really changed in the context of the commercial and Medicare advantage dynamics as it relates to 2005, we've tried to say last last quarter as well as this one is that we're going to be very methodical in rolling this out.
Michael Sarcone: We're going to be methodical in rolling out access to specialty pharmacy distribution, as well as buying bill into these customer bases or insurance types. And so, you know, obviously, we do expect some contribution over the course of the year from that. But we're really not anchoring our assumptions as it relates to our guidance or IDOS results underneath it, based upon positive or negatives associated with the commercial and Medicare Advantage rollout. Those are things that we want to make sure that we're very methodical in doing. And so, we're not pinning the forecast based upon a certain level of achievement of volumes out of those insurance types.
Speaker Change: We're going to be methodical and rolling out access to specialty pharmacy distribution as well as buy and bill into this customer are these customer bases or insurance types and so obviously, we do expect some contribution over the course of the year from that but we're really not anchoring our assumptions as it relates to our guide.
Speaker Change: Since or items results underneath it based upon positive or negatives associated with the commercial and Medicare advantage rollout those are things that we want to make sure that we're very methodical and doing and so we're not we're not hitting the forecast based upon a certain level of achievement of volumes out of that those those insurance.
Speaker Change: Right.
Michael Sarcone: Understood, thank you.
Mike: Understood. Thank you and then Mike My follow up maybe on the P&L.
Alex Thurman: And then my follow-up, maybe on the P&L, OPEX, any change to your expectations for about 15% year-over-year growth off the adjusted 24-base? Hey, Mike, this is Alex. Thanks for the question. And at this point, no, I mean, we would continue to march down this path watching and balancing our investments against the revenues that are generated by Eidos and the rest of the business. And so we would continue to expect that 15% or so growth off the 2024 base on OPEX for the year.
Speaker Change: Opex any change to your expectations for about 15%.
Speaker Change: Year over year growth off the adjusted 24 base.
Speaker Change: Hey, Mike This is Alex Thanks for the question and at this point no I mean, we would continue to March down this path watching.
Speaker Change: Balancing our investments against the revenues that are generated by <unk> and the rest of the business and so we would continue to expect that 15% or so growth.
Speaker Change: 24 based on Opex for the year.
Anthony Petrone: Your next question is from the line of Anthony Petrone with Mizzou Group. Thanks and I hope everyone's doing well. Maybe a question just on the Meridian region specifically, iDose, sticking there, US iDose.
Anthony Petrone: Your next question is from the line of Anthony Petrone, when there's no growth.
Speaker Change: Alright, Thanks, and hope everyone is doing well.
Speaker Change: Maybe a question just on them the Radian region, specifically idose sticking their use idose, but if we look at it in the Radian region as being sort of further along in the product curve here, maybe just an idea of a heavy user in that region.
Anthony Petrone: If we look at the Meridian region as being, you know, sort of further along the product curve here, maybe just an idea of a heavy user in that region, you know, do you have sites that are getting up to, say, you know, 15, 20 units a month, and even in that region are there laggards, and what has the product experience been like where we do have a region where reimbursement is quite robust, and I'll have one quick follow-up. Yeah, Anthony, so for Meridian, which obviously I commented on earlier in the call from a macro perspective, so I'll focus on your sort of customer utilization question.
Speaker Change: Have sites that are getting up to say.
Speaker Change: 15, 20 units a month in.
Speaker Change: And even in that region or their laggards and what is the product experience been like where we do have a region, where reimbursement is quite robust and I'll have one quick follow up.
Anthony Petrone: Yes Anthony.
Anthony Petrone: So for Meridian, which obviously I commented on earlier in the call I'll call. It macro perspective, so I'll focus on your sort of customer utilization question.
Joseph Gilliam: I think it's all of the above. We absolutely have a customer and now growing customers, if you will, that are doing the 15 to 20 a month type volume for ITOs within Meridian. And we also have customers who are at very different phases of that adoption, some that are doing their first cases this week and or might be doing just a handful but haven't fully adopted yet and haven't had it streamlined in terms of their practice and patient selection, all the various things that go into having a successful adoption within a surgical group. We also have areas within the Meridian area that are performing much more strongly than others based upon the other dynamics in the context of either hospital approvals or other things that can slow the adoption curve within even that geography where you do have streamlined coverage.
Anthony Petrone: I think it's all of the above we absolutely have customer and now growing customers. If you will that are doing the 15 to 20, a month type volume for Idose within the Caribbean and we also have customers who are at very different phases of that adoption. Some that are doing their first cases.
Anthony Petrone: This week.
Anthony Petrone: And where it might be doing just a handful but haven't fully.
Anthony Petrone: Adopted yet and haven't had it streamline in terms of their their practice and patient selection all the various things that go into having a successful adoption within our within our surgical group.
Anthony Petrone: We also have areas within the <unk> area that are performing much more strongly than others based upon the dynamics of the context, either hospital approvals or or other things that can slow the adoption curve within even that geography, where you do have streamlined our coverage.
Joseph Gilliam: Helpful, and just a quick one here is leveraging the balance sheet. Should we think about leveraging the balance sheet to close the doughnut hole? That's, I would assume, more a commercial coverage sort of event, but maybe just a recap on the view from Glaukos on leveraging the balance sheet to close the doughnut hole for iDOS. Yeah, I'll take a shot. I think I know what you're saying. The donut hole, and this is a buy and bill product. So it's about the donut hole, but it's more about the patient out of pocket, associated with commercial, you know, payer lives.
Anthony Petrone: Helpful and just a quick one here is leveraging the balance sheet should we think about leveraging the balance sheet to close the donut hole.
Anthony Petrone: I would assume more commercial coverage sort of event, but maybe just a recap on the view from glaucoma on leveraging the balance sheet to close the donut hole for Idose.
Yes.
Anthony Petrone: I'll take a shot I think I know, what you're saying.
Speaker Change: <unk> this is a buy and bill.
Speaker Change: So it talks about the <unk>, but it's more about the patient out of pocket.
Speaker Change: Associated with commercial Payor lives and we absolutely intend to like most.
Joseph Gilliam: And we absolutely intend, like most, you know, pharmaceutical products in the buy and bill category, to have, you know, $0 copay programs. So we will, quote unquote, use the balance sheet, if you will, to make sure that out of pocket coverage costs are not an issue to impeding utilization for those commercial, you know, payer patients.
Speaker Change: Pharmaceutical products and the buy and Bill category.
Speaker Change: Zero dollar co pay program. So we will quote unquote use the balance sheet. If you will to make sure that out of pocket coverage costs are not an issue to competing <unk>.
Speaker Change: Realization for those those commercial payer patients.
Danielle Antalffy: Your next question is from the line of Danielle Antalffy with UBS. Hello, can you hear me okay? We can, yeah. Okay, so sorry about that, guys. Just a high-level question for you guys. As iDOS ramps, and I appreciate the 2025 headwinds to the U.S. iSTEM franchise, but longer term, you know, what do you think is the right way to think about the long-term growth rate for the legacy iSTEM franchise in an environment where iDOS is hopefully ramping pretty rapidly? Like, what's the right way to think about the balance of those two businesses and how quickly the legacy iSTEM business can grow?
Speaker Change: Your next question is from the line of Danielle and Kathy with UBS.
Speaker Change: Hello can you hear me okay.
Speaker Change: We can.
Speaker Change: Okay.
Speaker Change: Sorry about that.
Speaker Change: Just high level question for you guys.
Speaker Change: Dallas ramps and I appreciate that 2025 headwinds to the U S. Istent franchise, but longer term. What do you think is the right way to think about the long term growth rate for the legacy Istent franchise.
Speaker Change: And environment, where idose is hopefully ramping pretty rapidly like what's the right way to think about the balance of those two businesses.
Speaker Change: And how quickly the.
Speaker Change: Legacy Istent business can grow and I had one quick follow up after that.
Joseph Gilliam: And I have one quick follow-up. Yeah, Danielle, I think there's a couple different ways to parse that. I mean, first of all, obviously, over the course of 2025, you have just the, you know, relative impact of the LCDs as a headwind to growth, as we've alluded to, and I think others in the industry have as well. But as you get past that, you're still talking about an industry segment where you're moving from a pretty small patient population in combination with cataract surgery into a very, very large potential patient population in standalone interventional glaucoma. And I think if there was one thing that we certainly took away from, you know, the AGS earlier this year and ASCRS more recently, it's that, you know, this movement in partnership with physicians and increasingly in alignment with the broader industry is, we're really leading the charge to once again change standard of care in glaucoma and improve patient outcomes.
Speaker Change: Yes.
Speaker Change: There's a couple of different ways to parse that I mean first of all obviously over the course of 2025, you have just the relative impact of the LCD is a headwind to growth as we've alluded to and I think others in industry as well, but as you get past that youre still talking about an industry segment, where you're moving from a pretty small piece.
Speaker Change: Shunt population in comedy for cataract surgery into a very very large potential patient population.
Speaker Change: Standalone interventional glaucoma and I think if there was one thing that we certainly took away from.
Speaker Change: The Ags earlier this year in Crs more recently is that this movement.
Speaker Change: In partnership with physicians and increasingly in alignment with the broader industry is.
Speaker Change: We're really leading the charge that once they get change the standard of care in glaucoma and improve patient outcomes.
Joseph Gilliam: But I think, you know, we have more conviction now that this transformation, as Tom alluded to, an IG mindset is well underway. If you look at the sheer number of events, symposiums and conversations and debates, it's pretty encouraging as you think about that long term growth dynamic for doing the right thing for patients and intervening early and as needed for these patients.
Speaker Change: We have more conviction now that this transformation as Tom alluded to in IGT mindset is.
Speaker Change: He is well underway.
Speaker Change: You look at the sheer number of events symposiums and conversations and debate.
Speaker Change: It's pretty encouraging as you think about that long term growth dynamic for doing the right thing for patients and intervening early and is needed for.
Joseph Gilliam: So that's a long-winded way of saying, I think you have, you know, a decade plus period here where both products like IDOS as well as stents and other areas of MIGS alongside of stents can grow in tandem as more and more surgeons adopt a proactive mindset and really go after tackling this disease, which we believe is a surgical one. Okay, gotcha. That makes sense.
For these patients so that's a long winded way of saying I think you have.
Speaker Change: A decade, plus period here, where both products like idose as well as stenson and other areas of Migs alongside a sense can grow in tandem as more and more surgeons adopt a proactive mindset and really go after tackling this disease, which we believe is.
Speaker Change: Surgical one.
Speaker Change: Okay got you that makes sense and then just follow up on that is istent infinite and the Standalone market development, I mean, where would you characterize how we are today, what what are the barriers that you guys are still addressing there because that really does feel like the long term opportunity here for <unk>.
Joseph Gilliam: And then just a follow up on that is Iceland Infinite and the standalone market development. I mean, where would you characterize how we are today? What are the barriers that you guys are still addressing there? Because that really does feel like the long term opportunity here for Iceland Infinite. Thanks so much. Yeah, we agree. And I think, you know, if you think about where we're at relative to those of us in the room and in the building who were there when when we were changing the standard of care and pioneering and combination of cataract surgery, I would say, and I think Tom would agree that we're well ahead of that curve from a timeline perspective and changing the standard of care as it relates to the standalone procedures.
Speaker Change: Got it thanks, so much.
Speaker Change: Yes, we agree and I think if you think about where we're at relative to those of us in the room in the building to where their win win we were changing the standard of care and pioneering in comedies for cataract surgery, I would say and I think Tom would agree that we're well ahead of that curve from a timeline perspective.
Speaker Change: <unk> and changing the standard of care as it relates to the Standalone procedures, having said that it never happens as fast as we would want it or certainly you all as investors or analysts would once it takes changing one surgeons.
Joseph Gilliam: Having said that, it never happens as fast as we would want or certainly you all as investors or analysts would want. It takes changing one surgeon's, you know, not just their clinical mindset, but then their operating behaviors and the things they do to educate their referral networks and ultimately getting these patients treated in an interventional way. And the good news is we're well underway on that front with with quite a few early adopters that have already shifted their patterns. And that's only growing. And as I mentioned, that was that was on full display at ACRS.
Speaker Change: Not just their clinical mindset, but then they're operating behaviors and the things they do to educate their referral networks and ultimately getting these patients treated in interventional way.
Speaker Change: And the good news is we're well underway on that front with with quite a few early adopters that have already shifted their patterns.
Speaker Change: That's the only growing and as I mentioned that that was that was on full display to Srs.
Joseph Gilliam: And we couldn't help but but but be pleased with what we were seeing. And I was going to say that with what's happened just in the last 18 months or so, since we have put our really turned our turrets towards this intervention of a couple of mindset and mind frame. You can see it at AGS, you see it at ASCRS. There's clearly going to be a strong movement in the direction that we want. I think that the standalone is an incredible, unexploded opportunity, not only for ICE and Infinite, but as you think about it and do your models in the future, as I said earlier, what I do believe strongly is that surgeons will increasingly look to be able to take and be able to place a procedural pharmaceutical, in this case, an i-dose, in combination with an infinite, to be able to maximize their opportunity to lower target pressures and preserve the vision of these glaucoma patients.
Speaker Change: We couldnt help but be pleased with what we're seeing.
Speaker Change: Say that one.
Speaker Change: What's happened just in the last really 18 months or so.
Speaker Change: Since we have put our.
Speaker Change: Really turned our tourists towards sincere mentioned of our copper mindset in mind frame.
Speaker Change: You can see here that Ags you see it today, a crs theres clearly going to be a strong movement in the direction that we want I think that the stand alone is an incredible unexploited opportunity not only for Istent infinite.
Speaker Change: Think about it in your models in the future as I said earlier, what I do believe strongly is that surgeons will increasingly look to.
Speaker Change: To be able to take.
Speaker Change: And be able to place a procedural pharmaceutical in this case a high dose in combination with an infinite.
Speaker Change: To be able to maximize our opportunities in the lower target pressures.
Speaker Change: And preserve.
Speaker Change: The vision of the communist patients and so.
Joseph Gilliam: And so, I think you're going to see growth on both sides. I don't think they'll happen at the expense of each other. I think that these two products can work in tandem, particularly out in years as surges become increasingly comfortable placing dual modalities into the eye.
Speaker Change: I think youre going to see growth on both sides I don't think it will happen at the expense of each other I think that these two products can work in tandem, particularly in the outer years as surgeons become increasingly comfortable.
Speaker Change: Placing the dual modality center.
Speaker Change: Okay.
Patrick Wood: Our final question will come from the line of Patrick Wood from Morgan Stanley. Perfect. Thanks so much. I'll keep it just to one.
Speaker Change: Our final question will come from the line of Patrick Wood from Morgan Stanley.
Patrick Wood: Perfect. Thanks, so much I'll keep it just to one.
Patrick Wood: I'd love to hear a little bit about what you guys are hearing back from the patients and also the docs' conversations with the patients when it comes to iDOS. Is this a quick and easy conversation and there's quite a lot of buy-in from the patients right away? I mean, it seems a fairly easy value prop to communicate, but obviously you have the doc buy-in already. I'm just curious how you feel the conversations between the docs and the patients are going and if you've had any feedback on that. Thanks. Yeah, Patrick, I think that from a physician standpoint, there's always a journey around the conversation they have with patients, in particular, where you're recommending, you know, interventional glaucoma procedure, and in this case, obviously, IDOS.
Patrick Wood: I'd love to hear a little bit about what you guys are hearing back from the patients and also the.
Speaker Change: The docs conversations for the patient when it comes to Idose.
Speaker Change: Is this a quick and easy conversation and there's quite a lot of buying from the patients right away I mean, it seems a fairly easy value prop to communicate but obviously you have the dock buying already I'm just curious like how you feel the conversations between the docs and the patients going and if you've had any feedback on that thanks.
Speaker Change: Yes, Patrick I think that from a physician standpoint, theres always a journey around the conversation they have with patients in particular, where youre recommending interventional glaucoma procedure and in this case, obviously idose, but what you see is.
Thomas Burns: But what you see is, every day, them getting better at that, and certainly as folks become more comfortable and confident with the outcomes, which we're seeing are, are terrific. That enables them to then speak with that much more confidence to the patients who are walking into their practice, and recommending is something that they would do for their own eye or for their mother's eye, if they were afflicted with glaucoma. And so I think we're making tremendous progress there. And most important, the foundation that underpins all of this is that the product is performing as advertised, and as a result, the physician enthusiasm continues to grow around it.
Speaker Change: Everyday them getting better at that and certainly as folks become more comfortable and confident with the outcomes, which we're seeing are are terrific.
Speaker Change: That enables them to then speak with that much more confidence to the patients who are walking into their practice and recommending is something that they would do or their own ire for their mothers I. If they were afflicted with glaucoma and so I think we're making tremendous progress there and most important the foundation that underpins all of this.
Speaker Change: Is it the product is performing.
Speaker Change: As advertised and as a result of physician enthusiasm continues to grow around it downstream of that they will continue to perfect. How they operate how they talk to patients in all the various things that ultimately make this become what we think it will be.
Thomas Burns: Downstream of that, they will continue to perfect how they operate, how they talk to patients, and all the various things that ultimately, you know, make this become what we think it will be. Great stuff. Thanks, guys.
Speaker Change: Great. Thanks, guys.
Speaker Change: Thank you I will now hand.
Operator: I will now hand the call back over to the company for closing remarks. Okay, I want to thank you all for your time and attention today. And thank you as well for your continued interest in support of Glaukos. Goodbye. This concludes today's call. Thank you for joining. You may now disconnect your line.
Speaker Change: I will now hand, the call back over to the company for closing remarks.
Speaker Change: Okay I want to thank you all for your time and attention today.
Speaker Change: You as well for your continued interest and support of Marcos Goodbye.
Speaker Change: This concludes today's call. Thank you for joining you may now disconnect your lines.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: Okay.