Q1 2024 Glaukos Corporation Earnings Call

Unknown Executive: Welcome to Glaukos Corporation's first quarter 2024 financial results conference call. Copies of the company's press release and quarterly summary document, both issued after the market closed today, are available at www.glaukos.com. All lines have been placed on mute to prevent any background noise.

Welcome to go outcomes Corporation's first quarter 2024 financial results conference call copies of the company's press release and quarterly summary document both issued after the market closed today are available at Www Dot Guac coast Dotcom all lines have been placed on mute to prevent any background noise.

Unknown Executive: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question, simply press the star followed by the number 1 on your telephone keypad. To withdraw your question, press star 1 again. This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

After the Speakers' remarks, there will be a question and answer session. If you would like to ask a question simply press star followed by the number one on your telephone keypad to withdraw your question Press Star. One again this call is being recorded and an archived replay will be available online in the Investor Relations section at Www.

W. W Dot, while Costar Com I will now turn the call over to Chris Lewis, Vice President of Investor Relations and corporate Affairs.

Christopher William Lewis: Thank you and good afternoon. Joining me today are Glaukos Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman.

Christopher William Lewis: Thank you and good afternoon, joining me today are walkers, chairman and CEO, Tom Burns, President and CEO, Joe Gilliam, and CFO Allen Berryman.

Christopher William Lewis: Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter, the state of the company's business objectives and strategies, and any forward statements or guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call.

Christopher William Lewis: Similar to prior quarters. The company has posted a document on our Investor Relations website under the financials and finally quarterly results section titled Quarterly summary.

Christopher William Lewis: This document is designed to provide the investment community, but to summarize and easily accessible reference document.

Christopher William Lewis: He tells me that's associated with the quarter.

Christopher William Lewis: The company's objectives strategies any forward statements or guidance, we may make.

Christopher William Lewis: Acumen is designed to be read by investors or the regularly scheduled quarterly conference call as such for this call. We will make brief prepared remarks and transition to a question and answer session.

Christopher William 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 Q&A.

Christopher William Lewis: To ensure ample time and opportunity to address everyone's questions we request.

Christopher William Lewis: That you limit yourself to one question one follow up.

Christopher William Lewis: If you still have additional questions you may get back into the queue.

Christopher William 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, 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.

Christopher William 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.

Christopher William Lewis: <unk> technologies, and clinical trials U S and international commercialization market development efforts efficacy of our current and future products.

Christopher William Lewis: Mid 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.

Christopher William Lewis: Operations.

Christopher William 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 data. Please review today's press release and our recent SEC filings for more information about these risk factors.

Christopher William Lewis: These statements are based on current expectations about future events affecting us and are subject.

Christopher William Lewis: The 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 in today's press release and our recent SEC filings for more information about this.

Christopher William Lewis: Risk factors, you'll find these documents in the investors section of our website at Www dot.

Christopher William Lewis: Dot Com finally, please note that during today's call. We will also discuss certain non-GAAP financial measures.

Christopher William Lewis: On an adjusted basis, we believe these financial measures can facilitate a more complete analysis and greater transparency into glaucoma ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available on the Investor Relations section of our website for a reconciliation of.

Christopher William Lewis: These measures to their most directly comparable GAAP financial measure.

Christopher William Lewis: You'll find these documents in the investor section of our website at www.glaukos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations. Particularly when comparing underlying results from period to period, please refer to the tables and our earnings press release available in the investor relations section of our website for reconciliation of these measures to their most directly comparable gap financial measures. With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns. Okay, thanks, Chris. Good afternoon.

Christopher William Lewis: With that I will turn the call over to glaucoma, Chairman and CEO Tom Burns.

Thomas William Burns: Okay, thanks Chris. Good afternoon, and thanks to all for joining us today. Today, Glaukos reported record first quarter consolidated net sales of $85.6 million, up 16% versus the year-ago quarter. As a result of our strong start to the year, we are increasing our full year 2024 NED sales guidance range to $357 to $365 million versus $350 to $360 million previously. These record results were broad-based, with 20% year-over-year growth achieved in both our U.S. and international glaucoma franchise, where we continue to accelerate efforts to expand access to interventional glaucoma tools for the benefit of physicians and patients.

Thomas William Burns: Thanks, Chris Good afternoon, and thanks to all for joining us today.

Today Golf Coast reported record first quarter consolidated net sales of $5 6 million up 16% versus the year ago quarter.

Thomas William Burns: As a result of our strong start to the year, we are increasing our full year 2024, net sales guidance range to 357 to 365 million versus 350 to 360 million previously.

Thomas William Burns: These record results were broad based with 20% year over year growth achieved in both our U S and international glaucoma franchises, where we can.

Thomas William Burns: Continue to accelerate efforts to expand access to interventional glaucoma tools for the benefit of physicians and patients.

Thomas William Burns: Our goal to advance and improve glaucoma care by driving earlier intervention continues to build momentum as we lead and work closely with surgeons and thought leaders globally to organically drive this broader evolution in the standard of care. These efforts were on full display at the AGS conference in late February, and more recently at the ASCS meeting last month, where the interest and excitement levels for interventional glaucoma and our technologies were palpable. Within our U.S. Glaucoma franchise, we delivered first quarter sales of $42 million on strong year-over-year growth of 20% driven by Icestat Infinite and our overall Icestat portfolio.

Thomas William Burns: Our goal to advance and improve glaucoma care by driving earlier intervention continues to build momentum as we believe and work closely with surgeons about theaters globally to organically drive this broader evolution in the standard of care.

Thomas William Burns: These efforts were on full display and Ags conference in late February and more recently at the <unk> meeting last month, where the interest and excitement levels for interventional glaucoma and our technologies were culpable.

Thomas William Burns: With that our glaucoma franchise, we delivered first quarter sales of 42 million on strong year over year growth of 20% driven by Istent infinite and our overall portfolio.

Thomas William Burns: Market receptivity and adoption of Ice then infinite remain strong as we continue to pioneer and lead the interventional glaucoma paradigm shift. In parallel, we continue to advance key market access initiatives to support consistent and dependable professional fee payment, with five of the seven MACs now including CBT code 0671T on the latest fee schedules. During the first quarter, we also commence the initial phases of our controlled launch plan for IDOS-TR, a revolutionary microinvasive injectable therapy designed to lower intraocular pressure in patients with open angle glaucoma or ocular hypertension. IDOS-TR is a first-of-its-kind intracameral procedural pharmaceutical designed to deliver glaucoma drug therapy for up to three years. I could not be more pleased with how the early stages of this launch have gone.

Thomas William Burns: Market receptivity and adoption of Istent infinite remains strong as we continue to pioneer and lead the international glaucoma paradigm shift.

In parallel we continue to advance key market access initiatives to support consistent and dependable professional fee payment with five of the seven Max now, including CPT code or 671 cheat on their latest schedules.

Thomas William Burns: During the first quarter. We also commenced the initial phases of our controlled launch plan for Idose TR are revolutionary Micron base of injectable therapy designed to lower intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Idose TR is a first of its kind intra camera procedural pharmaceutical designed to deliver glaucoma drug therapy for up to three years.

Thomas William Burns: I could not be more pleased with how the early stages of the slots have got our initial targeted wave of 15 surgeons all successfully completed our idose initial idose TR procedures during the first quarter and the early feedback and outcomes have been very positive.

Thomas William Burns: Our initial target wave of 15 surgeons all successfully completed their initial IDOS-TR procedures during the first quarter, and the early feedback and outcomes have been very positive. As a reminder, these early access surgeons provide valuable insight to our training and field teams that helps to optimize training and skills transfer to our sales force and surgical community, supporting our expanded training and broader launch efforts over the course of 2024. In addition to training, a key element to the stage gating of our iDOS-TR commercial launch is market access, where there have been several recent positive reimbursement developments designed to support fullsome coverage and payment for the IDOS-TR procedural pharmaceutical over time.

Thomas William Burns: As a reminder, these early access surgeons provide valuable insight to our training and field teams that helps to optimize training and skills transfer to our salesforce and surgical community supporting our expanded training and a broader launch efforts over the course of 2024.

Thomas William Burns: In addition to training a key element to the stage gating of our Idose TR commercial launch is market access where there have been several recent positive reimbursement developments designed to support fulsome coverage and payment for the Idose TR procedural pharmaceutical overtime.

Thomas William Burns: So first, CMS assigned a unique permanent J code for IDOS-TR, J7355, said to become effective on July 1st, 2024. This new J code, once effective, is expected to increase patient access here in the United States and should provide more streamlined, consistent, and dependable coverage and payment for IDOS-TR as we advance and ultimately accelerate our initial commercial launch activities. Second, CMS assigned the CPT codes that are designed to be used to cover the procedural component of IDOS-TR 0660-T and 0661-T to Ambulatory Payment Classification, or APC 5492, effective April 1, 2024. This translates into a National Average Facility Fee of nearly $3,900 in the House HOPD setting and more than $2,000 in the ASC setting.

Thomas William Burns: So first CMS aside that unique permanent J code for our Idose TR J $735 five set to become effective on July one 2024.

Thomas William Burns: This new J code once effective suspect is expected to increase patient access here.

Thomas William Burns: United States and should provide more streamlined consistent dependable coverage and payment fraud, STR as we advance and ultimately accelerate our initial commercial launch activities.

Thomas William Burns: CMS aside the CPT codes that are designed to be used to cover the procedural component of Idose TR over $6 six <unk> 6612, ambulatory payment classification or APC 549, two effective April one 2024.

Thomas William Burns: This translates into a national average facility fee of nearly $3900 in the house.

Thomas William Burns: <unk> setting.

Thomas William Burns: And more than $2000 in ASC setting.

Thomas William Burns: Third, we have participated in several initial education meetings with MACS as part of our efforts to secure professional fee coverage and payment over the course of 2024. And fourth, we successfully entered into the Medicaid Drug Rebate Program, or MDRP. And finally, fifth, we have successfully commenced early initiatives to secure coverage for commercial and Medicare Advantage plans, efforts that we plan to accelerate in the second half of 2024 after the J code is effective.

Thomas William Burns: Third we have participated in several initial education meetings was Max as part of our efforts to secure a professional fee coverage and payment over the course of 2024.

Thomas William Burns: And fourth we successfully entered into the Medicaid drug rebate program or DRP.

Thomas William Burns: And finally fifth we are successfully commenced early initiatives to secure coverage for commercial and Medicare advantage plans efforts that we plan to accelerate in the second half of 2024. After the J code is effective.

Thomas William Burns: So, in summary, the response we have received from surgeons in the broader ophthalmic community since FDA approval and the more recent initial commercial launch activities has been overwhelmingly positive and reaffirms our view that, with the launch of ITOS-TR, we are pioneering a brand new category of procedural pharmaceuticals that has the potential to reshape glaucoma management as we know it today. We are excited to now be building a strong foundation to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension.

Thomas William Burns: So in summary, the response, we received from surgeons of the broader ophthalmic community.

Thomas William Burns: FDA approval and the more recent initial commercial launch activities has been overwhelmingly positive and reaffirms our view that with the launch of Idose TR. We are pioneering a brand new category of procedural pharmaceuticals that has the potential to reshape glaucoma management as we know it today.

Thomas William Burns: We are excited to now be building the strong foundation to bring this transformative technology to market and expand the treatment alternatives for patients suffering with glaucoma and ocular hypertension.

Thomas William Burns: Moving on, our international glaucoma franchise delivered record sales of $25.2 million on year-over-year growth of 20% on a reported basis and 21% on a constant currency basis. This strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive MIGS forward, which is a standard of care in each region in every major market in the world. We remain in the early stages of expanding our IG initiatives globally ahead of what we hope will be supported by a healthy pace of new product approvals and expanding market access in the years to come.

Thomas William Burns: Moving on our international Glaucoma franchise delivered record sales of $25 2 million year over year growth of 20% on a reported basis and 21% on a constant currency basis.

Thomas William Burns: This strong growth was once again broad based as we continue to scale, our international infrastructure and execute our plans to drive <unk> forward.

Thomas William Burns: As the standard of care in each region in every major market in the world.

Thomas William Burns: We remain in the early stages of expanding our <unk> initiatives globally ahead of what we hope will be supported by a healthy cadence of new product approvals and expanding market access in years to come.

Thomas William Burns: And finally, the corneal health franchise delivered sales of $18.4 million on 4% year-over-year growth, including TREXIS sales of $15.1 million on 7% year-over-year growth. These first quarter results do include, in particular, the impact of our entry as a company into MDRP. These dynamics were anticipated and will continue to impact TREXA realized revenues going forward.

Thomas William Burns: And finally, our corneal health franchise delivered sales of $18 4 million up 4% year over year growth, including for <unk> sales of $15 1 billion on a year over year growth of 7%.

Thomas William Burns: These first quarter results do include in particular, the impact of our entry as a company into empty ERP.

Thomas William Burns: These dynamics were anticipated and will continue to impact from trexler realized revenues going forward.

Thomas William Burns: Shifting gears, we continue to prudently invest in and successfully advance our pipeline of promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. This concludes Epioxa, our next-generation corneal cross-linking therapy, for which we continue to progress towards trial completion in the second Phase III pivotal trial and remain on track for data readout in the second half of this year, supporting our targeted NDA submission by the end of 2024.

Thomas William Burns: Shifting gears, we continue to prudently invest and successfully advanced our pipeline of novel promising.

Thomas William Burns: Platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time.

Thomas William Burns: This includes <unk>, our next generation corneal cross linking therapy for which we continue to progress towards trial completion in the second phase III pivotal trial and remain on track for data readout in the second half of this year supporting our targeted NDA submission by the end of 2024.

Thomas William Burns: We continue to make enrollment progress in several important clinical trials, including one, a PMA pivotal trial for Iostin Infinite in mild to moderate glaucoma patients. Phase II, a Phase IIa study for dilution travel cost, with an initial data readout expected later this year. 3 Phase 2 trials for iLinc 3rd generation therapy.

Thomas William Burns: We continue to make enrollment progress in several important clinical trials, including one a PMA pivotal trial for Istent infinite in mild to moderate glaucoma patients to our phase Iia study for our recent travel costs with an initial data readout expected later this year.

Thomas William Burns: Three phase III trials for our Io link.

Thomas William Burns: Third generation therapy.

Thomas William Burns: And four, a first-in-human clinical development program for GLK401, our intravitreal multikinase amphibitor retinal program in wet AMD patients. We also remain on track to commence a phase three study for IDOS T-Rex, our next generation IDOS therapy by the end of 2024. Beyond these clinical activities, our development teams continue to pursue potential game-changing early-stage programs across the areas of glaucoma, retina, and rare diseases. So, in conclusion, I'm pleased with the strong start to the year given our team's solid execution.

Thomas William Burns: And for a first in human clinical development program for <unk> on our interim vitriol multi kinase inhibitor retinal programs in wet AMD patients.

Thomas William Burns: We also remain on track to commence a commence a phase III study for Idose T Rex or next generation Idose therapy by the end of 2024.

Thomas William Burns: Beyond these clinical activities our development teams continue to pursue potential game changing early stage programs across many areas of glaucoma and retina and rare disease.

Thomas William Burns: So in conclusion I am pleased with the strong start to the year given our team's solid execution.

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

I'd like to thank the nearly 1000 glaucoma employees, who remain dedicated to the work in advancing our strategic plans.

Thomas William Burns: We look forward to continuing to sustain and build upon the growing momentum in our business over the coming quarters and years.

Thomas William Burns: Our foundation is strong and our teams are energized as we are ideally positioned to continue transforming vision for the benefits of patients worldwide.

Speaker Change: So with that I'll open the call for questions operator.

Unknown Executive: At this time, as a reminder, to ask a question, press star 1 on your telephone keypad. Our first question will come from the line at the Tom Stephan with Stiefel. Please go ahead.

Speaker Change: At this time as a reminder to ask a question press star one on your telephone keypad. Our first question will come from the line of Tom Stefan with Stifel. Please go ahead.

Thomas M. Stephan: Great. Hey, guys, thanks for the questions. Maybe I'll start with the guide. Can you maybe talk about what the changes are to the constructs of the full year revenue outlook, if we can begin there? And then is there any more color or, I guess, parameters you'd be willing to provide on what's baked in for EIDOS?

Thomas M. Stephan: Great Hey, guys. Thanks for the questions.

Thomas M. Stephan: I'll start on the guide.

Thomas M. Stephan: Can you maybe talk about what the changes are to the construct of the full year revenue outlook. We can begin there.

And then is there any more color or I guess parameters you'd be willing to provide on what's baked in for idose.

Thomas M. Stephan: Yes.

Joseph E. Gilliam: Sure, Tom. It's Joe. Thanks for the questions. And I'll start off with the guidance. Obviously, we had a stronger than expected start to the year. And we were pleased to be able to raise the full-year guidance accordingly here just a couple months after setting it for the year. I'll call it a couple key considerations that are worth highlighting and then kind of hopefully draw to a conclusion in terms of the expectations by the franchise. First, it obviously is very early in IDO's launch, with the vast majority of the contribution expected in the latter part of the year. But that hasn't changed.

Thomas M. Stephan: Sure Tom its Joe Thanks for the questions and I'll start off with the guidance.

Joseph E. Gilliam: Obviously, we had a stronger than expected start to the year end and we were pleased to be able to raise the full year guidance. Accordingly here just a couple of months after setting it for the year.

I'll call. It a couple of key considerations I think that are worth highlighting and then kind of hopefully draw. Some included in terms of the expectations by the franchise.

Joseph E. Gilliam: First.

It obviously is very early and Idose launch with the vast majority of the contribution expected in the latter part of the year that Hasnt changed everything that we've been doing so far in the first quarter is on track and on target and we can I'm sure talk about that more later.

Joseph E. Gilliam: Everything that we've been doing so far in the first quarter is on track and on target, and we can, I'm sure, talk about that more later. Some of the stint growth that we saw in the first quarter, which was very strong from a year-on-year basis, is partially driven by the timing of the infinite launch activities last year, which really accelerated in the second quarter. So I think as we move into the second and third quarters, the comp from a stint standpoint starts to get a little bit more difficult.

Joseph E. Gilliam: Some of the state growth that we saw in the first quarter.

Joseph E. Gilliam: It was very strong from a year over year basis.

Joseph E. Gilliam: Driven by the timing of the imminent launch activities last year, which really accelerated in the second quarter. So I think as we move into the second and third quarters. The comp from a state standpoint gets starts to get a little bit more difficult.

Joseph E. Gilliam: Third, obviously, we all know that FX rates and the strengthening dollar have been moving against many of us from a U.S. reporting standpoint. So we see an incremental 200 basis points of growth headwind on the international side as we move forward throughout the year based on the spot rates as they exist today. And then lastly, as Tom mentioned in the prepared marks, we do expect the MDRP entry-related headwinds to persist for our corneal health franchise throughout the year.

Joseph E. Gilliam: Third obviously, we all know that FX rates and the strengthening dollar had been moving against.

Joseph E. Gilliam: Many of us from a U S reporting standpoint, so we see an incremental 200 basis points of growth headwind on the international side as we move forward throughout the year based on the spot rates as they exist today and then lastly, as Tom mentioned in the prepared remarks, we do expect that the MD RP entry related headwinds to persist for our corneal health franchise throughout the year. So.

Joseph E. Gilliam: So you put all that together, I think we're landing in a place where our expectations for the cornea franchise are low to mid-single-digit growth for the year. And that'll land you somewhere for the U.S. glaucoma business in the high teens to maybe its top end 20% type growth year over year.

And you put all that together.

Joseph E. Gilliam: I think we're landing at a place where we our expectations for the cornea franchise are low to mid single digit growth for the year.

Joseph E. Gilliam: International Glaucoma business, we tick up a little bit I think the expectations there should be low to mid double digit.

Joseph E. Gilliam: Our teens growth.

Joseph E. Gilliam: For the year and that will land us somewhere for the U S glaucoma business in that high teens to maybe at the top end, 20% type growth year over year. So hopefully that gives you a sense of kind of the drivers.

Joseph E. Gilliam: So hopefully that gives you a sense of kind of the drivers of where we're at. On your second question around IDOS-TR, I think at this point, we're obviously quite early. We were very pleased to see that in mid-February, as we told you, we were getting going. And so in the second half of the quarter, we were able to get kicked off with the early access phase of our IDOS launch. And, as Tom mentioned, we were really pleased to see our initial 15 surgeons be able to complete their cases in Q1 in coordination with our sales and training and market access teams.

Joseph E. Gilliam: Where we're at.

Joseph E. Gilliam: On your second question around Idose TR I think at this point, we're obviously quite.

Joseph E. Gilliam: Quite early we were very pleased to see that in mid February. We told you. We were we could go away and so in the second half of the quarter, we were able to get kicked off with the early access phase of our Idose launch and as Tom mentioned I'm really pleased to see our initial 15 surgeons to be able to complete their case.

Joseph E. Gilliam: Cases in Q1 in coordination with our sales and trading and market access teams and and Thats, how we will continue to methodically launch.

Joseph E. Gilliam: And that's how we'll continue to methodically launch and slowly expand in Q2, ahead of obviously the J-code being established in Q3 and the ASP publication in Q4, where we start to expect a meaningful acceleration in IDOS-related activities and volume.

Joseph E. Gilliam: And slowly expand in Q2 ahead of obviously the J code being established in Q3 of ESP publication in Q4, where we start to expect a meaningful acceleration of the idose related activities and volumes.

Thomas William Burns: That's great, Collar. Thanks, Joe. And then maybe we can switch to the pipeline.

Speaker Change: That's great color. Thanks, Joe and then maybe switching to the pipeline.

Thomas William Burns: Tom, you alluded to this a bit, but we did see in your proxy that the company is developing Eidos Trio, which appears to be an in-office version of the implant. If you're willing to share, can you elaborate a bit on the product? Maybe the key details, sort of the portfolio fit, I guess. And then any timelines or milestones? Thanks.

Tom you alluded to this a bit but we did see in your proxy that the company is developing Idose trio, which appears might be in an office version of the implant.

Speaker Change: If youre willing to share can you elaborate a bit on product maybe the key details sorted the portfolio fit I guess, and then any timelines or milestones.

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

Tom: Yes, I'd be happy to address that time, and so I think it's inevitable as we look at the evolution of the pipeline that we will continue to figure out ways and develop ways to have an even more minimally invasive and pass off procedure.

Tom: So having said that I think it's incumbent upon us to develop a product that will be able to be even more micro invasive than the current idose design and.

Tom: And have an applicator that we'll be able to to really be able to put.

Tom: The idose product through an incision size, that's going to be able to be in the range of a one two to one millimeter incisions.

Which really gives US then the opportunity to create a self sealing construct or chaparral clear corneal incision.

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

Tom: I think that'll be important particularly.

Tom: Particularly as surgeons move to in office procedures, which we know that they will do it which is a compelling part of our strategic plan over the course of the planning period. So we are in the process of developing an applicator that we'll accomplish and achieve those goals.

Tom: I would say in the timing we'd be looking for would be probably in late 2025.

Tom: For potential introduction.

Tom: That will then be timely with the effect of how we'll be moving forward to give surgeons the opportunity to be able to exercise.

Tom: The site of service in office as well as the ASC.

Tom: Yeah.

Unknown Executive: Got it. That's helpful. Thanks again.

Speaker Change: Got it that's helpful. Thanks again.

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

Speaker Change: Your next question comes from the line of Ryan Zimmerman with BTG. Please go ahead.

Ryan Benjamin Zimmerman: Hey, good afternoon, congratulations on all the progress. I'm going to follow up on Tom's questions that I'm sure a lot of people will be asking about eye dose. But, you know, you gave us a little detail here on 15 surgeons kind of completing initial eye dose TR cases. Now, many of us have been, you know, deliberating over this, and it would seem as though there are maybe more surgeons out there, or at least there's a lot of excitement out there.

Hey, good afternoon, congrats on all the progress.

I'm going to follow up on Tom's questions that I'm sure a lot of people will be asking our idose, but.

Ryan Benjamin Zimmerman: You gave us a little detail here on 15 surgeons kind of completing initial idose TR cases, now many of us have been.

Ryan Benjamin Zimmerman: Diligence in this and it would seem as though there may be more surgeons out there or at least there's a lot of excitement.

Ryan Benjamin Zimmerman: Just to confirm, have you put eye dose in the hands of more than the 15? Number one, and then two, you know, how do you think about expanding that beyond that initial wave of the 15 in the second quarter until kind of that J code's effective? And are you gating adoption in any way, or kind of holding demand, you know, before that J code is effective?

Ryan Benjamin Zimmerman: Out there.

Ryan Benjamin Zimmerman: To confirm have you put in the hands of more than 15.

Ryan Benjamin Zimmerman: Number one and then two kind of how do you think about expanding that beyond that initial wave of <unk> in the second quarter and Tom kind of that J codes effective in and are you gaining adoption in any way.

We're kind of holding demand.

Ryan Benjamin Zimmerman: Before that J code is effective.

Joseph E. Gilliam: Sure. Thanks, Ryan.

Tom: Sure. Thanks, Ryan I think that the answer to the number of surgeons, who bad access and I think a little bit you are reacting to that number one the overall enthusiasm for Idose TR and some of the pent up demand for folks to get trained and get going with it over the course of the year.

Joseph E. Gilliam: I think the answer to the number of surgeons who've had access, and I think a little bit you're reacting to, number one, the overall enthusiasm for IDOS-TR and some of the pent-up demand for folks to get trained and get going with it over the course of the year. But the direct answer is, yeah, now that we're sitting here on May 1st, we continue to expand. We're past that.

Speaker Change: But the direct answer is yes, now that we're sitting here on May one of course, we continue to expand we're past that the 15 number from a surgeon training perspective was as of the end of the first quarter. So you would expect us to continue to be slowly expanding that and providing more access to folks at the same time.

Joseph E. Gilliam: The 15 number from a surgeon training perspective was as of the end of the first quarter. So you would expect us to continue to be slowly expanding that and providing more access to people. At the same time, we're going to do so methodically. You know, as we talked about from the outset, I think even back to the IDOS call in December, the way we will launch this product is those early access physicians expanding that very slowly and methodically over the course of the second quarter, and then really starting to open that more broadly as we get into the second half of the year with the J-code being established.

Speaker Change: We're going to do so methodically.

Speaker Change: As we talked about from the outset, I think even back to the items call in December the way, we will launch this product as those early access physicians expanding that very slowly and.

Speaker Change: Methodically over the course of the second quarter, and then really starting to open that more broadly as we get into the second half of the year with the J code being established.

Joseph E. Gilliam: At the same time and in parallel, we are working with these accounts, and so simply because a surgeon maybe hasn't completed their first case does not mean that they're not in the funnel, or if you're doing channel checks, expressing their enthusiasm, because they're being trained. Their back office or administrative staff are being trained, and so we're continuing to make progress, really, on all those fronts as we move forward into what we think will be a pretty exciting, certainly, second half, and, most notably, fourth quarter for this year with IDOS.

At the same time and in parallel.

Speaker Change: We are working with these accounts and so simply because the surge and maybe that Hasnt completed their first case does not mean that theyre not in the funnel or if youre doing channel checks expressing their enthusiasm because they are being trained.

Speaker Change: They are back office administrative staff are being trained and so we're continuing to make progress really on all those fronts as we as we move move forward into what we think will be a pretty exciting certainly second half and most notably fourth quarter for this year provide us.

Joseph E. Gilliam: Okay, very helpful. And then, you know, kind of dovetailing off that, Joe. I mean, if you are in those accounts... You know, I'm curious. What impact or pull through are you seeing as a result of the IDOS efforts on the base business? And if you could kind of tie it to this infinite growth, particularly in the US, I would venture to guess that the market is not growing anywhere near 20%.

Speaker Change: Okay.

Speaker Change: Helpful and then kind of Dovetailing off that Joe I mean, if you are in those accounts.

Speaker Change: I'm curious.

Speaker Change: What impact or pull through what youre seeing as a result of the idose efforts on the base business and if you.

Speaker Change: You've had kind of tied to the infinite growth, particularly in the U S. I mean.

Joseph E. Gilliam: I would venture to guess that the market is not growing anywhere near 20% and so are you taking share are you is the market growing faster now because you are spending more time in account. So just maybe you could elaborate on kind of the core <unk> business and the resulting impact from your efforts on Idose.

Joseph E. Gilliam: And so, are you taking share? Are you, is the market growing faster now because you are spending more time on accounts? Just maybe you could elaborate on kind of the core mixed business and the resulting impact. Yes, it's a great question.

Joseph E. Gilliam: Yes, it's a great question, you know, so I'll provide a little bit of color that I think will help you triangulate around the breakdown of the results of the first quarter for the U.S. glaucoma business. We did see our overall stent portfolio, including iStent Infinite, grow in the mid-teens on a year-over-year basis. So the majority of what you're seeing, not all, obviously we did have IGOS-TR and some of those early launch activities, but the majority of the growth that you're seeing, the tune of mid-teens growth, is coming from our SENT portfolio. I think it's, you know, it's, of course, very hard to dissect that down to individual percentage breakdowns, but I do think it's a little bit of all of those things that you mentioned, Ryan.

Speaker Change: Yes, it's a great question, so I'll provide a little bit of color I think will help you triangulate it around the breakdown of the results. The fourth first quarter for the U S. Glaucoma business, we did see our overall sustained portfolio, including Istent infinite grow in the mid teens on a year over year basis. So the majority of what Youre seeing now.

Speaker Change: We did have idose TR and some of those early launch activity, but the majority of the growth that youre seeing the tune of mid teens growth is coming from our stent portfolio I think it's.

Speaker Change: Yes of course, it's very hard to dissect that down to individual percentage breakdowns, but I do think it's a little bit of all of those things that you mentioned Ryan I think that we are growing the market because of as Tom mentioned, we put a lot of muscle and effort into the interventional glaucoma paradigm shift.

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

Not something new we've been working on that hard over the course of the last <unk>.

Speaker Change: 18 months in particular, and I think youre starting to see some of the benefit of that in terms of growing the overall market certainly faster than it would be still restricted the combination cataract setting.

Joseph E. Gilliam: But at the same time, I also do think we're taking a little bit of market share. And I think the fact that we're in there with multiple new, exciting technologies that help expand the portfolio of alternatives for these surgeons, you can't help but benefit a little bit from that in the context of a halo obviously associated with the overall portfolio. And so I think that that is playing out a little bit as we make our way through the year so far.

Speaker Change: But at the same time I also do think we're taking a little bit of market share and I think the fact that we're in there with multiple new exciting technology to help expand the portfolio of alternatives for the surgeons you can't help but benefit a little bit from that in the context of a halo, obviously associated with overall portfolio and so I think that.

Speaker Change: He is playing out a little bit as we as we make our way through the year so far.

Speaker Change: Thank you.

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

Speaker Change: Your next question comes from the line of Larry Nicholson with Wells Fargo. Please go ahead.

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

Lawrence H. Biegelsen: Good afternoon, and thanks for taking the question and congratulations on a really strong quarter here.

Lawrence H. Biegelsen: Joe you raised the guidance at the midpoint by I think the amount of the beat why or why not more in the Q2 to Q4.

Lawrence H. Biegelsen: Growth implied or implied growth is actually below the Q1 growth I think at the midpoint.

Speaker Change: Just lastly on there.

Speaker Change: How should we think about Q2 are you comfortable with consensus of call it $88 million.

Joseph E. Gilliam: Yeah, Larry, so I think in the context of why not more than the beat? Well, over the course of the two months, I'm not so sure since our original guidance that things have changed markedly versus expectations and what we saw coming into the year. We've executed on everything we expected to and done a little bit better than that. And so we wanted to make sure that that was reflected in the increased guidance.

Joseph E. Gilliam: Yes, Larry So I think I'll try to get the order in which you asked you asked it but the context of why not more than the beat over the course of the two months I'm not so sure since our original guidance that things have changed.

<unk> versus the expectations and what we saw coming into the year, we've executed on everything we expected too.

Joseph E. Gilliam: And done a little bit better than that and so we wanted to make sure that that was reflected in the raised guidance, but when you think about getting ahead of that so much of that obviously is driven by expectations around idose in particular.

Joseph E. Gilliam: But when you think about getting ahead of that, so much of that obviously is driven by, you know, expectation around IDOS in particular. And as I've said, and we've said for some time now, that's, for the most part, a second half phenomenon that we expect to play out. So I'm not sure sitting here today that we would make a significant change to our expectations around IDOS and what it'll do in the second half. But we certainly continue to execute against realizing that opportunity at that point in time.

Joseph E. Gilliam: And as I've said, and we've said for some time now.

Joseph E. Gilliam: For the most part a second half.

Joseph E. Gilliam: Phenomenon that we expect to play out so I'm not sure sitting here today, we would make a significant change to our expectations around idose and what it will do in the second half, but we certainly have continued to execute against <unk>.

Joseph E. Gilliam: Realizing that opportunity at that point in time.

Joseph E. Gilliam: If you think about Q2, I alluded to this a little bit in the question around the guidance. Our first quarter did benefit a bit from two things. One, on the international side, currency was a little bit more favorable than it's going to be going forward. We see an incremental 200 basis points, or 2% of headwind on that international growth number as we enter the second quarter than what we experienced in the first, given the strengthening of the dollar.

Speaker Change: Yes, if you think about Q2 I alluded this a little bit on the question around the guidance for our first quarter did benefit a bit from two things one on the international side currency was a little bit more favorable than it's going to be going forward, we see an incremental 200 basis points or 2% of headwind on that into.

Speaker Change: National growth number as we enter the second quarter than what we experienced in the first given the strengthening of the dollar and.

Joseph E. Gilliam: And second, we really fulsomely launched ICE at infinite in the second quarter of last year. So from a year over year comp standpoint, it gets a little bit more challenging as we enter the second quarter and beyond than it was in the first from a growth standpoint. So I think you put those things together, and you'll see why and where we landed. The last thing I'll say on that is from a seasonality standpoint when you kind of think about the overall guidance. In a week, as you know.

Speaker Change: And second we've really more forcefully launched istent infinite in the second quarter of last year. So from a year over year comp standpoint, it gets a little bit more challenging as we enter the second quarter and beyond than it was in the first from a from a growth standpoint. So I think you put those things together and you'll see why and where we landed.

Speaker Change: The last thing I'll say on that is from a seasonality standpoint, when you kind of think about the overall guidance.

Speaker Change: As you know we expected our typical seasonality patterns have been disrupted this year by the growing istent infinite Standalone and of course idose utilize that utilization in the second half.

Joseph E. Gilliam: We expected our typical seasonality patterns to be a bit disrupted this year by the growing ice in Infinite Standalone and, of course, IDOS utilization in the second half, and the net effect of that is obviously to shift a bit more of the contribution of the year to the second half and, in particular, the fourth quarter. And if I were to try to put percentages around that, I might do something like the following.

Speaker Change: And the net effect of that is obviously to shift a bit more of the contribution of the year to the second half and in particular the fourth quarter.

Speaker Change: I would try to put percentages around that I might do something like the following.

Joseph E. Gilliam: 23-24% in Q1, 24-25% in Q2 and Q3, and 26-28% of the year in Q4. I think if you follow that, you'll get to a pretty good place in the context of the seasonality expectations that we have for 2020.

Speaker Change: 43, 4% in Q1.

Speaker Change: 24%, 25% in Q2, and Q3 and 26% to 8% of the year in Q4, I think if you followed that youll get to a pretty good place in the context of the seasonality expectations that we have for 2024.

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

Speaker Change: That's helpful and Joe just to follow up on the Idose ramp.

Joseph E. Gilliam: I mean, how should we think about the ramp.

Joseph E. Gilliam: What's going to cause that inflection in Q4 is it is it the J code.

Speaker Change: Coming into effect.

Speaker Change: July 1st until we'll see an inflection in Q3, just it sounds like the contribution in Q1 was relatively small.

Speaker Change: How do you see whats going to drive the adoption through the year. Thanks.

Joseph E. Gilliam: Yeah, I mean, obviously, our expectations would be that the contribution in the first quarter would be relatively small. I mean, we launched it in mid-February and gave early access, and we're on schedule with all that. I think we'll continue to expand that over the course of Q2. But to the heart of your question, there are really two significant unlocking events, if you will, from an adoption perspective. The first happens on July 1st, when the J-code comes into place.

Speaker Change: Yes.

Speaker Change: Obviously, our expectations I think would be the.

Speaker Change: Contribution in the first quarter was relatively small, but we launched it in mid February and.

Speaker Change: Early access and we're on schedule with all of that I think will continue to expand that over the course of Q2, but to the heart of your question. There are really two significant.

Speaker Change: Significant unlocking events, if you will from a from a.

Speaker Change: An adoption perspective, the first happens on July one when you have the J code come into place. There's obviously a lag effect there in terms of our procedures being scheduled in the execution towards that J code, but then as you get into the fourth quarter and the ASP is also published at that point you have.

Joseph E. Gilliam: There's obviously a lag effect there in terms of procedures being scheduled and the execution towards that J-code. But then, as you get into the fourth quarter, and the ASP is also published, at that point, you have a much more, I'll call it, automated payment system from a Medicare standpoint. When you have the established J-code and a published ASP, it really enables a much more normalized process for reimbursement at the account level. And we expect that to be pretty important in the unlocking, obviously, of surgeons really being able to run and do IDOS on all the patients that they think are appropriate for the technology.

Speaker Change: More.

Automated payment system from a Medicare standpoint, when you have the established J code and a published Asps.

Speaker Change: It really enables a much more normalized process for reimbursement at the account level and we expect that to be pretty important in the in the unlocking obviously.

Speaker Change: Surgeons really be able to run and do Idose and all the patients that they think are appropriate for the technology.

Speaker Change: Thanks, a lot.

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

Speaker Change: Your next question will come from the line of Matt O'brien with Piper Sandler. Please go ahead.

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

Matt O'brien: Afternoon. Thanks for taking the questions, maybe just to follow up a little bit on Larry's question. There on the performance of the Idose in Q1, and yes, youre going to get a million of those questions on the call but.

Speaker Change: If I look at if I think about the.

Speaker Change: The base business, maybe growing somewhere in the mid teens, if I, if I back that out I'm looking at somewhere around something like a seven figure.

<unk> in the first quarter as said another way over $1 million is that about the right number and Thats just on 15 docs right just kind of trailing it trying to figure out the J code is that in the ballpark.

Joseph E. Gilliam: I'm not going to get too specific in endorsing, you know, any one number, but obviously you've got the overall growth of the U.S. glaucoma franchise and you've got the portfolio growing in the mid-teens from a year-over-year standpoint, so you, as you've done, can do the applied math on that. I'll just reiterate what we said.

Speaker Change: Well I'm not going to get too specific in the endorsing any one number but obviously you've got the overall growth of the U S. Glaucoma franchise and you've got the state portfolio grew in the mid teens from a year over year standpoint. So you as you've done can do the implied math on that I'll just reiterate what we said I mean at the end of the day, they were 15 and planning.

Joseph E. Gilliam: I mean, at the end of the day, there were 15 implanting surgeons in the first quarter. They had about a half of a quarter to do those procedures based on the timing of our launch, and it was encouraging to see both, most importantly, the enthusiasm for the outcomes for those patients after they had done their initial implantations of IDOS. And they managed to provide us exactly what we needed, the kind of pearls and information that helped us, you know, dial in our training and ultimately establish confidence with our sales force as they executed on a growing basis over the course of the next several quarters.

Speaker Change: <unk> in the first quarter, they had about a half of a quarter or to do those procedures and based on the timing of our launch.

Speaker Change: And it was encouraging to see both most importantly, the enthusiasm for the outcomes for those patients after they after they've done their initial implementations of Idose and they managed to provide is exactly what we need to kind of pearls and information that help us.

Speaker Change: Dial in our training and ultimately established confidence with our sales force.

Speaker Change: Execute on a growing basis over the course of the next several quarters.

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

Speaker Change: Got it and then the follow up just on the profitability side.

Speaker Change: So I think you said historically.

Speaker Change: Once you launch.

Speaker Change: <unk> profitability. The gross margin was good this quarter and should we expect that to dip a little bit as idose ramps and then and then improved meaningfully going forward are nicely going forward and then the spend also.

Much better than we were expecting just given all the activities around <unk>.

Speaker Change: During the quarter. So can we start to see profitability start to ramp pretty meaningfully over the next maybe 18 months. Thanks.

Alex R. Thurman: Hey Matt, it's Alex. I'll go ahead and take those questions. So we'll start with gross margin. Yeah, we were pleased with 83% in the quarter, for sure, but as we mentioned on the last call, and I'll say it again, when you launch a new product, it's bound to see some inefficiencies in the operations as you start to ramp up that product and the manufacturing and all the costs that are associated with that. So what we would tell you or what I would guide you to is some level of a range. You know, we've always said 83 or 84.

Alex R. Thurman: Hey Matt, it's Alex, so I'll go ahead and take it.

Speaker Change: Hey, Matt its Alex I'll go ahead and take those questions. So we'll start with gross margin. Yes, we were pleased with 83% in the quarter for sure.

Alex: As we mentioned in our last call and I'll say it again as you know when you launch a new product it's bound to see some inefficiencies in the operations as you start to ramp up that product and the manufacturing and the all the costs that are associated with that so what we would tell you are what I would guide you to is <unk>.

Alex R. Thurman: We hope to continue to play in that range this year, but there should be and could be some volatility as we go through the next couple of quarters and IDOS gets ramped up. And then we think about the margin, you know, being accretive over time with IDOS for sure. And we would look forward to that accretion and seeing some of that next year. On the operating side, you're right; we were pleased with the 92 if I back out the IP R&D charge of 11.7 million.

Alex: Some level of a range.

Alex: <unk> always said 80 384, we hope to continue to play in that range. This year, but there should be it could be some volatility as we as we go through the next couple of quarters.

Alex: This gets Ram.

Alex: Ramped up.

Alex: And then we think about the margin being accretive over time with items for sure. We would look forward to that accretion and seen some of that next year on the operating side Youre right. We were pleased with the 92, if I back out the IP R&D charge of $11 7 million. So that was nice the one thing I'll just stay on the expense side is that in Q1 of last year.

Alex R. Thurman: So that was nice. The one thing I'll just say on the expense side is that in Q1 of last year, you know, the R&D spend was much higher than normal because we had all of the IDOS pre NDA activities that were happening, as well as a large PDUFA fee payment that needed to be made. And so that kind of explains a little bit of the slowdown if you're comparing on a year over year basis.

Alex: Sure.

Alex: The R&D spend was much higher than normal because we had all of the idose pre NDA activities that were happening as well as a large could you fast speed payment that needed to be made and so that kind of explains a little bit of the slowdown if youre comparing on a year over year basis.

Alex: Yeah.

Speaker Change: Got it thank you.

Unknown Executive: Your next question comes from the line of George Sellers with Stevens. Please go ahead.

Speaker Change: Your next question comes from the line of Jordan Sadler with Stephens. Please go ahead.

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

Jordan Sadler: Hey, Thanks for taking the question maybe.

Jordan Sadler: Maybe sticking with the Idose theme could you just provide some additional color on maybe where youre seeing our belief utilization in the first quarter and also quarter to date here in the second quarter.

Jordan Sadler: If that's in conjunction with stenting procedure or another Migs procedure and then also what stage of the disease progression. These patients who are receiving an idose.

Jordan Sadler: Our.

Jordan Sadler: Okay.

Joseph E. Gilliam: Hey George, it's Joe. I think at this point when you're early in a product launch like this, you try to keep it as simple as possible. The more variables you introduce, the more challenging it becomes in terms of both education of the salesforce, as well as for the accounts and execution on there. And so, as you know, and as we've said in the past, the primary goal there is for clean, standalone utilization of IDELS.

Joseph E. Gilliam: Hey, George it's Joe.

Joseph E. Gilliam: I think at this point.

Joseph E. Gilliam: When you are early in our product launch like this you try to keep it as simple as possible. The more variables you introduced the more challenging it becomes in terms of.

Joseph E. Gilliam: <unk> education of the sales force as well as for the accounts and the execution on there and so as you know and as we've said in the past. The primary goal. There is for clean Standalone utilization of Idaho now, having said that have we seen surgeons for clinical reasons do it either in combination with cataract surgery or <unk>.

Joseph E. Gilliam: Now, having said that, have we seen surgeons for clinical reasons do it either in combination with cataract surgery or in combination with ICD-9 Infinite? The answer is yes, we have, based upon the clinical needs of those patients. And so, we will continue to monitor that and bring it forward. So, I think we're really thinking very close to the playbook that we had prescribed as we drive this forward, and we'll continue to see surgeons expand the use case of IDELS as we go forward.

Joseph E. Gilliam: Combination with Istent infinite the answer is yes, we have based upon the clinical needs of those patients and so we will continue to monitor that and bring it forward. So I think we're really.

Joseph E. Gilliam: Sticking very close to the playbook that we had it prescribed as we drive this forward and we will continue to see surgeons expand the use case of items as we go forward utilization itself and the trends associated very different from account.

Joseph E. Gilliam: Utilization itself and the trends associated with it are very different from, you know, account to account. Those accounts who have experience in billing miscellaneous codes, we've seen them really start to utilize IDELS more fulsomely. For those with a little less experience, they'll start, they'll try, they'll do a handful, and then wait for the payments to pull through before they greenlight that broader adoption.

Joseph E. Gilliam: Account to account those accounts, who have experience in billing miscellaneous codes, we've seen them really start to utilize idose more fulsomely for those with a little less experience. The bill start we'll try to do a handful.

Joseph E. Gilliam: And then and wait for the payments to pull through before they green light that broader adoption.

Joseph E. Gilliam: Okay, that's really helpful, Keller. And then maybe going back to a prior question on this call, how should we think about surgeon training progressing sort of going forward? You know, what's your capacity for the number of surgeons you'd be able to train on a quarterly basis, particularly as we think about maybe the fourth quarter and into 2025?

Speaker Change: Okay, that's really helpful color.

Speaker Change: And then maybe.

Speaker Change: Going back to a prior question on this call how should we think about surgeon training progressing sort of going forward whats your capacity for number of surgeons you'd be able to train on a quarterly basis, particularly as we think about maybe the fourth quarter and into 2025.

Joseph E. Gilliam: Well, if you look back, if you think about the training from a salesforce standpoint on our various products, I think the peak that we achieved was quite some time ago from a stint standpoint where we were doing 700 to 800 surgeons a year. I think one of the big differences with IDOS is that the majority of the surgeons that we're training have already gone through angle-based surgery, and so from that standpoint, those early cases that are really designed to teach them or re-teach them the nuances of angle-based surgery, you have a lot less of that.

Speaker Change: Well, if you look back.

Speaker Change: If you think about the training from a salesforce standpoint of our various products I think the peak that we achieved was now quite some time ago from a spend standpoint, where we were doing seven to 800 surgeons.

Speaker Change: Year.

Speaker Change: One of the big differences with Idose is that the majority of the surgeons that were training have already gone through angle based surgery and so from that standpoint.

Speaker Change: Those early cases that are really designed to teach them re teach them.

Speaker Change: The nuances of Eagle based surgery, you have a lot less of that so I think that we are.

Joseph E. Gilliam: So I think that we're going to set aggressive targets for the commercial organization to train as many doctors as possible, certainly as we get into the fourth quarter, going into 2025, and we'll dial that in for you all as we get into that phase and we start to really see what the salesforce can achieve in a quarter-in-a-half.

Speaker Change: To set aggressive.

Speaker Change: <unk> targets for the commercial organization to train as many doctors as possible is certainly as we get into fourth quarter and going into 2025.

Speaker Change: And we will dial that in for you all as we get into that into that phase and we start to really see what the salesforce can achieve quarter in and quarter out.

Unknown Executive: Okay, great. I'll leave it there. And thank you all again for the time.

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

Speaker Change: Sure.

Unknown Executive: Your next question will come from the line of Alan Gong with J.P. Morgan. Please go ahead.

Speaker Change: Your next question will come from the line of Alan <unk> with J P. Morgan. Please go ahead.

Alan Gong: Thanks for the question. Just one on IDOS as well, you know. You talked about how you're working to get coverage from Medicare and commercial plans. You know, a question that I've been getting is just concerns around copays and areas of Medicare and commercial insurance where, you know, the out-of-pocket is not necessarily covered. How do you plan to address that in cases where, you know, you can't provide some additional financial, you know, cushion, I suppose, and where supplemental insurance isn't as prevalent? Yeah, Alan, something that we spent an awful lot of time on.

Alan: Thanks for the question just one on Idose as well you talked about how you're working media coverage.

Alan: Medicare and commercial plans a question that I've been getting is just concerns around the co pay and areas of Medicare and commercial ware.

Alan: The out of pocket and not necessarily covered.

Alan: How do you plan to address that in cases, where you can provide some additional financial.

Alan: Cushion I, suppose and where supplemental insurance isn't as prevalent.

Alan: Yeah.

Joseph E. Gilliam: Yeah, Alan, something that we spent an awful lot of time obviously thinking about and assessing and analyzing in detail as a team, well before we set the price and certainly launched IDOS. I'd break it down this way.

Speaker Change: Yes Alan.

Speaker Change: Something that we spend an awful lot of time, obviously thinking about and assessing and analyzing in detail as a team.

Speaker Change: Well before we set the price and certainly launched Idose I'd break it down this way obviously within the Medicare fee for service World, which is significant obviously portion of the relevant wives. Your exist. The vast vast majority of those patients actually have some degree of supplemental coverage. It can vary from a lot of different places whether it.

Joseph E. Gilliam: Obviously, within the Medicare fee-for-service world, of which a significant, obviously, portion of the relevant lives here exist, the vast, vast majority of those patients actually have some degree of supplemental coverage. It can vary from a lot of different places, whether it's supplemental from Medicaid or whether it's from commercial plans or other supplemental coverage plans that they may have. So, for the vast majority of those patients, you'll have really little to no out of pocket. The second major bucket you allude to is obviously within the commercial arena.

Speaker Change: Supplemental from Medicaid or whether it's from commercial plans or other supplemental coverage plans that they may have so for the vast majority of those patients youll have really little to no out of pocket. The second major bucket you allude to was obviously within the commercial arena and for that we will be approaching at similar to any drug launch or the vast majority.

Joseph E. Gilliam: And for that, we'll be approaching that similar to any drug launch or the vast majority of drug launches out there. We will have full copay assistance such that, from that standpoint, patient economics will not be an impediment to the utilization of IDOS in that payer arena. And the last frontier for us, and, quite frankly, for most procedures and pharmaceuticals today will be Medicare Advantage, where a larger percentage of those patients have higher out of pocket costs, both in terms of the percentage as well as the overall maximum.

Speaker Change: Many of drug launches out there, where we will have full co pay assistance such that from that standpoint patient economics will not be an impediment to the utilization of items in that in that payer arena and the last frontier for us quite frankly for most procedures in pharmaceuticals today will be Medicare advantage.

Speaker Change: Were a larger percentage of those patients have a higher.

Speaker Change: Out of pocket, both in terms of the percentage as well as the overall maximum and that's something that is not unique to obviously idose worthwhile because net perspective, there are a decent percentage of those patients who do have no to low copay and.

Joseph E. Gilliam: And that's something that is not unique to, obviously, IDOS or Glaucus in that respect. There are a decent percentage of those patients who do have no to low copays. And for those who have higher ones, you tend to see them get treated more in the later part of the year when they may have already exhausted their, you know, out of pocket maximums earlier in the year with whatever procedures have been in place.

Speaker Change: And for those who have a higher you tend to see them get treated more in the later part of the year when they may have already exhausted.

Speaker Change: They are.

Speaker Change: Out of pocket Maximums earlier in the year with whatever procedures.

Speaker Change: Have arisen over the course of that year.

Speaker Change: Yeah.

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

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

Joanne Karen Wuensch: Good evening, and thank you for taking the questions. I have two. The first one has to do with what I sent infinite.

Joanne Karen Wuensch: Good evening and thank you for taking my questions I have two.

Joanne Karen Wuensch: The first one has to do with Iceland Internet.

Joanne Karen Wuensch: That seems to be getting lost a little bit and the idose. Okay.

Thomas William Burns: I mean, that seems to be getting lost a little bit in the eye dose focus. How is that doing, and what percentage of the procedures today are in standalone procedures versus concomitant? And then I do have to ask about that, I guess, and you've been seeing street models and things like that. How are you feeling about full year contribution for IDOS?

Joanne Karen Wuensch: How is that doing and what percentage of the procedures today are in standalone procedures versus concomitant and then I do have to ask about.

Joanne Karen Wuensch: I know you've been seeing street models and things like that how are you feeling about full year contribution.

Speaker Change: For Idose and I want them just to make sure that expectations are set accordingly. Thank you.

Thomas William Burns: And I want to just make sure that expectations are set accordingly. Thank you. Well, thanks, Joanne. I think first

Thomas William Burns: Well, thanks, Joanne. First, I appreciate the question, Ice and Infinite. It does get lost a little bit in the shuffle of ITOS, and yet, it's an essential part of what we do every day right now in driving what we believe is sort of a shift in the standard of care towards interventional approaches and interventional glaucoma. To the heart of your question, of course, it's a little difficult to quantify with precision, and we don't have enough data to confidently say exactly how that breaks down between stand-alone and comedies with cataracts, but I can confidently say it was a key growth driver in the quarter.

Speaker Change: Well, Thanks, Julian I think first.

Speaker Change: I appreciate the question Istent infinite.

Speaker Change: It does get lost a little bit in the shuffle of Idose and yet.

Speaker Change: A central part of what we're doing every day right now and driving.

Speaker Change: What we believe is sort of a.

Speaker Change: A shift in the standard of care towards interventional approaches and interventional glaucoma.

Speaker Change: Part of your question is of course, it's a little difficult to quantify with precision precision and we don't have enough data to confidently say.

Speaker Change: Exactly how that breaks down between standalone and comedies of cataract, but I can confidently say it was a key growth driver of the quarter.

Thomas William Burns: And if you just look at it analytically, the reason why, you know, this is the reason why our SNF portfolio went from mid-single-digit growth in pretty much every quarter in 2023 to now mid-teens in the first quarter of 2024. What changed there clearly was the fact that we started to establish professional fees, and the APC assignment was reassigned to a level where the facilities weren't losing money anymore, and that really enabled the surgeons to start doing what they would have loved to have been doing all along from a clinical perspective.

Speaker Change: And if you just look at it analytically. The reason why this is the reason why our stent portfolio went from mid single digit growth in pretty much every quarter in 2023 to now mid teens in the first quarter of 2024.

Speaker Change: What changed there clearly was the fact that we started to establish professional fees.

Speaker Change: The APC assignment with reassigned to a level that the facilities are losing money anymore.

Speaker Change: And that really enables the surgeons to start doing.

Speaker Change: What they would have loved to have been doing all along from a from a clinical perspective. So it was the key driver obviously to the first quarter as we as we.

Thomas William Burns: So it was the key driver, obviously, for the first quarter as we had expected, but quite frankly, it did even better than we thought going into that first quarter. As it relates to IDOS and the full-year contribution, I don't think we've gotten that granular around how that will play other than to continue to reiterate that right now we're in that early access phase and will continue to be in that stage for at least the first half.

Speaker Change: I had expected, but quite frankly, it did even better than what we thought going into the end of that first quarter.

Speaker Change: As it relates to Idose and the full year contribution.

Speaker Change: I don't think we've gotten that granular.

Speaker Change: And how that will play other than they continue to reiterate that.

Speaker Change: Right now we're in that early access phase will continue to be in that stage for the at least the first half and then as you go into the third quarter and certainly the fourth quarter is the J code turns on the J code plus the ASP reimbursement, we would expect it to become a material driver.

Thomas William Burns: And as you go into the third quarter and certainly the fourth quarter, as JCODE turns on, and JCODE plus the ASP reimbursement, we would expect it to become, you know, a material driver of our results. When you look at what I said earlier around the seasonality that we'd expect and the shift towards the second half and the latter part, clearly, the vast, vast majority of that is being driven by, you know, IDOS and increasing utilization of that as we make our way through the year.

Speaker Change: Our results when you when you look at what I said earlier around the seasonality that we would expect the shift towards the second half of the lateral part clearly.

Speaker Change: The vast vast majority of that is being driven by items and increasing utilization of that as we make our way through the year.

Speaker Change: Yes.

Speaker Change: Thank you very much.

Unknown Executive: Your next question will come from the line of Margaret Caxer with William Blair. Please go ahead.

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

Margaret Caxer: Hey, good afternoon, folks. Thanks for taking the questions.

Malgorzata Maria Kaczor Andrew: Hey, guys. Thanks for taking my questions and I'm going to pile on on the Internet as well because obviously its growing at a pretty rapid pace. It seems like any words.

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

Malgorzata Maria Kaczor Andrew: And I guess, the comps are getting more difficult and I know youre, a little maybe not wanting to focus on sequential growth, but I guess from a dollar perspective can you give us any sense as to whether that number sequentially is accelerating and sustain similar et cetera, and then just a sense of penetration rate.

Malgorzata Maria Kaczor Andrew: Either from broader account usage in existing accounts.

Speaker Change: Unlike in connect person.

Speaker Change: I'm trying to get into new accounts.

Joseph E. Gilliam: Yeah, Margaret, I think that from a performance standpoint, it's certainly our expectation that Infinite would continue to grow sequentially, just based upon the organic efforts of our sales force around driving education, awareness, and training of ICE and Infinite, in particular in the standalone setting. So I think it's, it's, it's absolutely our expectation that that will continue to be a growing driver of our overall business. To your point, we may have varying degrees in terms of how that translates from a year over year growth perspective, just given comparable differences in 2023.

Speaker Change: Yes Margaret.

Speaker Change: That from a from a performance standpoint.

Speaker Change: Certainly our expectation that infinite would continue to grow sequentially just based upon the organic efforts of our of our sales force around driving education awareness and training.

Speaker Change: Istent infinite in particular in a standalone setting so I think it's <unk>.

Joseph E. Gilliam: But we absolutely expect it to be that. I think in terms of penetration, it's still really early. I mean, you've heard us talk about the standalone opportunity measured in a couple hundred thousand procedures for ICE and Infinite for patients who fail, you know, medical and surgical therapy. And so, you know, just in translating even the great results we had in the first quarter, we're still very early in the overall penetration paradigm of ICE and Infinite and where it can and we expect it to be utilized.

Speaker Change: Absolutely our expectation that that will continue to be a growing driver of our overall business to your point, we may have varying degrees in terms of how that translates from a year over year growth perspective, just given comparable differences in 2023.

Speaker Change: But we absolutely expect it to be that I think in terms of penetration.

Speaker Change: Still really early.

Speaker Change: You've heard us talk about the Standalone opportunity measured in a couple of hundred thousand procedures for Istent infinite.

Speaker Change: For patients who failed medical surgical therapy, and so just translating even the great results. We had in the first quarter. We're still very early in the overall penetration penetration paradigm.

Speaker Change: Istent infinite and where it can and we expect it to be utilized.

Speaker Change: Yeah.

Margaret Caxer: Okay, and, you know, I'll squeeze in kind of the two, both on IDOS as well as just a follow-up on the Internet. Because I think at our conference even last year, you guys spoke to your general enthusiasm that this is going to be a $50, $100 million plus business over time, maybe even faster than IDOS can get there. So I don't know if you can speak to your confidence level now that both products have launched, and that commentary about timing today versus last summer.

Speaker Change: Okay.

Speaker Change: And I'll squeeze in kind of the two both on Idose as well as just a follow up on Texas I think in our conference season last year, you guys had spoken until like just your general enthusiasm Atkinson is going at the $500 million plus business over time, maybe even faster than idose can get there. So I don't know if you can speak to your confidence level now.

Speaker Change: Both products have launched around that commentary around planning today versus last summer and then on the on the IDL side.

Margaret Caxer: And then on the IDOS side, you know, I'm not sure if you can give us any color around how, you know, the initial surgeons and clinicians are working IDOS into their workflow. You know, are they focusing a day exclusively on IDOS? You know, are these patients that have been waiting for a long time? You know, and how far out are these cases being booked? Thanks, guys.

Speaker Change: Yeah.

Speaker Change: I'm not sure if you can give us any color around how the initial surge and clinicians are working idose into their workflow are they focusing exclusively on Idaho are these patients that have been waiting for a long time.

Speaker Change: And how far out are these cases steamboat thanks guys.

Thomas William Burns: Well, I think, Margaret, that it's probably, I'm just going to answer the last one first, I think it's probably a little bit premature to make too bold of a statement with respect to how they're working it in, given where we're at in that launch curve. We certainly do have those surgeons who are now working in fulsomely in the context of how they think about an interventional approach to the treatment of patients, and they all have their own algorithms, but we're certainly seeing IDOS-PR in some of these thoughts become a prominent component of their algorithms.

Steamboat: Well I think Margaret it's probably I'm just can answer the last one first I think it's probably a little bit premature to make.

Steamboat: Too bold of a statement with respect to how theyre working it in.

Steamboat: Given given where we're at in that launch curve, we certainly do have those surgeons who.

Steamboat: We are now working in ultimately in the context of how they think about an interventional approach to the treatment of patients and they all have their own algorithms, but we're certainly seeing idose TR.

Steamboat: And some of these thoughts become a prominent component of the algorithm.

Thomas William Burns: As it relates to ICD-infinite and the overall size of the market, I don't think anything's changed there. I don't think we've changed our conviction. In fact, seeing the results that we've seen so far this year, it only probably increases the conviction around the ultimate use case of ICD-infinite and that it should be a several hundred million dollar product from a standalone perspective for us. Again, just going back to the size of the market, you don't have to change the paradigm around an interventionalist approach for ICD-infinite and its utilization in those patients who fail medical and surgical therapy.

Steamboat: As it relates to Istent infinite on the overall size of the market I don't think anything's changed there I don't think we've changed our conviction in fact seeing the results that we've seen so far this year at only probably increases the conviction around the ultimate use case of Istent infinite and that it should be a several hundred million dollars.

Steamboat: From a standalone perspective for US again, just going back to the size of the market you don't have to change the paradigm around an interventional approach for istent infinite to be utilized in those patients who fail medical surgical therapy. Those surgeons are already there it's about making sure that they have been trained and they have access and they are appropriately thinking about it.

Thomas William Burns: Those surgeons are already there. It's about making sure that they've been trained and they have access and they're appropriately thinking about it in the context of their own algorithms. But we have a lot of confidence in where that's going to lead over the course of time.

Steamboat: In the context of their own algorithms, but but we have a lot of confidence in where that's going to head over the course of time.

Unknown Executive: Your next question comes from the line David Saxon with Needham. Please go ahead.

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

David Joshua Saxon: Great. Good afternoon.

David Joshua Saxon: Great. Good afternoon, thanks for taking my questions.

David Joshua Saxon: A couple on Idose as well so it sounds like each of the 15 docs did about seven or eight in the first two months.

David Joshua Saxon: I guess its commercial during the quarter. So how quickly did you see that first cohort do the second and third procedures and so on did they wait until they got reimbursed from the first and then do five or six more or was it more even over the two months.

David Joshua Saxon: Thanks for taking my questions. There were a couple on IDOS as well. So, it sounds like each of the 15 docs did about seven or eight in the first two months that IDOS was commercial during the quarter. So, how quickly did you see the first cohort do the second and third procedures, and so on? Did they wait until they got reimbursed for the first and then do, you know, five or six more? Or was it more over the two months?

Joseph E. Gilliam: Thanks, David. I think it's a little early to do that. And I don't think, you know, sometimes, especially in the early days of the launch, to do that kind of math, which I certainly respect around the seven or eight, you just see a wide variation where there are some surgeons who've done more than that, obviously, and there are others who have done one or two or three or four and then waited for that reimbursement to come.

Speaker Change: Thanks, David I think it's a little early.

David Joshua Saxon: To do that.

Speaker Change: I don't think sometimes especially in the early days of launch to do that kind of the.

David Joshua Saxon: The math, which I certainly respect around the seven or eight.

David Joshua Saxon: You just see a wide variation, where there are some surgeons who have done more than that obviously and there are others, who have done one or two or three or four and then wait for that.

David Joshua Saxon: <unk> Com again back to my earlier point at this stage. It has a lot more to do with their experience with miscellaneous codes, both from a surgeon as well as the staff perspective than their understanding of how that will play out is driving the early adoption as much as anything else I think over time.

Joseph E. Gilliam: Again, back to my earlier point, at this stage, it has a lot more to do with their experience with miscellaneous codes, both from a surgeon's as well as a staff perspective, and their understanding of how that will play out is driving early adoption as much as anything else. I think over time, as that reimbursement confidence is established, you start shifting a lot more to, you know, the clinical conversation of when, where, and how they're deploying this. But for right now, it's coming down a lot to their experience within miscellaneous code, and waiting for that.

David Joshua Saxon: Is that reimbursement confidence is established you start shifting a lot more to the clinical conversation of when where and how they are deploying this but for right now it's coming down a lot to their experience within the miscellaneous code and.

David Joshua Saxon: And waiting for that payment.

David Joshua Saxon: Yes.

David Joshua Saxon: Okay, got it. And then, you know, we've talked in the past about the specialty pharmacy channel. So, you know, can you talk here about kind of what the process is to get that established? And, and how long that might take? And then, you know, thoughts on how, if at all, that will drive adoption further? Yeah, so the

David Joshua Saxon: Okay got it and then you've talked in the past about the specialty pharmacy channel. So.

Speaker Change: Can you talk.

Speaker Change: Here about kind of what the processes to get that established in and how long that may take and then thoughts on how if at all of that that drive adoption further.

Joseph E. Gilliam: Yeah, so especially pharmacy channels, not new to us, obviously, it's an important part of our business on the Botrexa side, one in which we're continuing to optimize each and every day. But it plays a very material role in the alcoholic distribution and channel strategy associated with Botrexa. Based upon that, the establishment of that from an ITOS perspective is already there. We have all of that ready.

Speaker Change: Yes, so the specialty pharmacy channel is not new to US obviously is an important part of our business on the <unk> side, one in which we're continuing to optimize each and every day, but it plays a very material role in the I'll call it distribution.

Speaker Change: And channel strategy associated with both <unk> and <unk>.

Speaker Change: Upon that the establishment of that from from a from an <unk> perspective is already there we have all of that ready, but you really don't expect to start driving.

Joseph E. Gilliam: But you really don't expect to start driving utilization within that channel until you start to turn on your commercial policies and drive that non-Medicare business, where the specialty pharmacy channel is most beneficial. And the second underlying layer of that, obviously, is that you're always cultivating relationships as the specialty pharmacy provider with the various payers that are out there. And so that process will be ongoing over the course of many years as you try to optimize the coverage within that channel to benefit those commercial patients who will rely upon it. But we're ready to go. It's much more about us really unlocking or releasing the commercial side of our ITOS business before we go.

Speaker Change: The utilization within that channel until you start to turn on your commercial policies and drive that non call. It Medicare business, where the specialty pharmacy channel is most beneficial in the second underlying layer of that obviously is that Youre always then cultivating the relationships as the specialty pharmacy provider.

Speaker Change: With various payers that are out there so that process will be ongoing over the course of many years as you try to optimize that covered within that channel to.

Speaker Change: To benefit those commercial patients who will rely upon it but we're ready to go it's much more about us really unlocking or releasing.

Speaker Change: On the commercial side of our of our Idose business before we start meaningfully making a change in the specialty pharmacy side.

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

Speaker Change: Your next question will come from the line of Sam Brodsky with truly Securities. Please go ahead.

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

Samuel E. Brodovsky: Hey, guys. Thanks for taking the questions two quick ones on Idose, and then I'll try and sneak in an international one as well.

Samuel E. Brodovsky: First just any update.

Samuel E. Brodovsky: Any color you can provide on.

Samuel E. Brodovsky: Incremental data on when you may get a replacement label or how those conversations with the FDA are evolving.

Thomas William Burns: Yeah, Sam, thanks for the question. Thanks for allowing me to engage after all the questions about the high dose commercial. As we talked about, we have, I believe, prepared a really compelling proposal to submit to the FDA. We waited, as you know, there's been a change in the guard at the FDA. And so that dust is still settling.

Speaker Change: Yes, Sam Thanks for the question, Thanks for allowing me to engage after all my questions.

Samuel E. Brodovsky: Gross commercial.

Speaker Change: Yeah, as we talked about we have I believe prepared a really compelling proposal to submit to the FDA. We've weighted as you know theres been a changing of the guard at the FTA and so that dust is still settling.

Thomas William Burns: So we will be proposing the movement towards re-administration in the coming days. We're hopeful to be able to get a positive response, but we're not counting on it. And I will tell you, as I've said before, one of the things that investors and analysts should be reassured by is that we have T-REX, which we're on track to begin that clinical trial by the end of the year. And when you do any kind of chronology of when our expectation is to have that commercially available, as we've talked about before, the best case would be at the end of 27 or beginning of 28.

Speaker Change: So we will be proposing.

Speaker Change: The movement towards re administration and really in the coming days.

Speaker Change: We're hopeful to be able to get a positive responsible we're not counting on it and I will tell you as I've said before one of the things that investors and analysts should be reinsured by is that we have T Rex, which we're on track or beginning that clinical trial by the end of the year and when you do any kind of chronology of when our.

Speaker Change: <unk> is to have that commercially available as we've talked about before best case would be at the end of 2017 to 28, and so any patient undergoing an istent implantation typically.

Thomas William Burns: And so any patient that is undergoing an ISDN implantation typically, or invariably, by the end of this year or early in 2025, we believe that the T-REX will become a compelling offering for re-administration for those patients.

Speaker Change: Our invariably by the end of this year early into 2025, we believe that the T. Rex will become a compelling offering for the administration for those patients.

Thomas William Burns: Great, that's helpful. And also, are there going to be any constraints as you roll out to more doctors, any constraints we should be considering in terms of how much they can adopt over the coming months before the JIC, whether that be supply or otherwise?

Speaker Change: Great. That's helpful and then also.

Speaker Change: Is there going to be any constraints as you rollout to more doctors any.

Speaker Change: We should be considering in terms of how much they can adopt over the coming.

Speaker Change: <unk> before.

Speaker Change: Jake whether that be supply or otherwise.

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

Jake: Well I think it's.

Speaker Change: At least in the I think the way you asked that question in the context of the second quarter ahead of the J code.

Jake: I think it's honestly more of the same.

Jake: As we experienced in the second half of February Youll see the second.

Jake: Second half of the first quarter Youre going to see some who are more confident and we will continue adopt based upon the clinical flow of their practice and obviously focused on the Medicare patient population and Youll see others, who will start and do some trying and ultimately wafer payment to adopt I don't expect there to be a meaningful.

Jake: Inflexion in the context of the second quarter as it relates to Idose other than the fact that we'll continue to slowly expand access to those surgeons.

Unknown Executive: Thanks guys, I'll leave it there.

Speaker Change: Okay. Thanks, guys I'll leave it there.

Unknown Executive: Your next question will come from the line of Anthony Petrone with Mizzouho. Please go ahead.

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

Speaker Change: Yeah.

Anthony Charles Petrone: Hey, guys.

Dimitriita Al-La-Lawn: This is Dimitriita Al-La-Lawn for Anthony. Congratulations again on a great quarter. So I saw in your summary that you had some initial educational meetings with the MACS as part of your efforts to secure professional fee coverage. Can you give us any updates on these talks? Do you have better insight? And the timing of when these professional fees will come through, and you know, could they come all at once from the max, or will it be staggered? I'll have a quick follow-up. Yeah, Dimitri, I think this is an ordinary course.

Anthony Charles Petrone: This is dmitry Tal one for Anthony.

Dmitry Tal: Congrats again on a great quarter.

Dmitry Tal: So I saw on your summary, you have had some.

Dmitry Tal: Initial educational meetings with the Max as part of your efforts to secure professional fee coverage.

Speaker Change: Can you give us any updates from these talks do you have better insight.

Speaker Change: On the timing of when these professional fee coverage will come through.

Speaker Change: Could they come.

Speaker Change: All at once from the Max will be staggered.

Speaker Change: I'll have a quick follow up.

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

Speaker Change: Yes, Dmitry I think this is ordinary course activity as we do any time, we launch new products. There is an education process just to make sure. Those Max you are open to being educated on a new product like Idose. They understand what it is and the procedure associated with the drug and so we've been executing on those as an ordinary course.

Speaker Change: If you look back at the history of <unk>, because as we've launched products professional fees tend to take somewhere between six to nine months on average to start being at least more consistent and what they are being paid and ultimately then be put on fee schedules and.

Speaker Change: They rarely happen all at once they tend to happen on whatever scheduled timeline. The Max themselves individually are on versus being one one fell swoop across multiple Max at a single point in time.

Speaker Change: Okay.

Dimitriita Al-La-Lawn: And quickly on gross margin, I know you came in a little bit lower than expectations, and I know that's kind of due to the launch. And do you just see that, do you see it stepping down next quarter, or do we see it step up next quarter and kind of through the rest of the year?

Speaker Change: And.

Speaker Change: Quickly on gross margin I know you.

Speaker Change: Came in a bit Florida than expectations.

Speaker Change: And I know that's kind of due to the launch can you just see that do you see stepping down next quarter.

Speaker Change: We see step up next quarter and kind of through the rest of the year.

Alex R. Thurman: Hey, Dimitris, Alex, I would say, you know, TBD, right? I'm kind of guiding you to keep in mind a range, you know, make it maybe between 80 and 84 over the course of the year because of the volatility or potential volatility of IDOS. And so again, I'll affirm that we are confident in the creative nature of IDOS, the close margin over time, and we should start to see that more fully suddenly as we exit this year on the internet.

Speaker Change: Hey, Dmitry, it's Alex I would say TBD right, we would just take it.

Alex: Im kind of Guy.

Alex: Guiding that you keep in mind a range maybe between 80 to 84 over the course of the year because of the volatility or potential volatility rollout items and so but we again olive curve that we are.

Alex: Confident in the accretive nature of items, the gross margin over time, and we should start to see that more full suddenly as we exit this year and enter next year.

Unknown Executive: Your next question will come from the line at Steve Lichtman with Oppenheimer and Company. Please go ahead.

Speaker Change: Your next question will come from the line of Steven Lichtman with Oppenheimer <unk> Company. Please go ahead.

Steve Lichtman: Thank you. Evening, guys.

Steven Lichtman: Thank you evening guys wanted to ask about the core U S glaucoma business and market.

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

Steven Lichtman: One of the things you had highlighted in an.

Steven Lichtman: Your summary is potential volatility from all.

Steven Lichtman: All of the Mac movement.

Steven Lichtman: At the latter part of 2023 are you still seeing some aftershocks from that one way or the other.

Steven Lichtman: And also if you could talk about what your expectations are looking forward are you hearing anything with regard.

Steven Lichtman: What might be next excuse me on the Mac front.

Joseph E. Gilliam: Yeah, I think it's been relatively quiet in the context of the impact. There is probably a modest benefit to the STEM side of our business, as some surgeons or practices have re-evaluated the tools that are being deployed based upon the objective data that's behind those tools. But I think it's a much smaller negligible impact to the quarter versus, as we've spent a lot of time here talking about the growing standalone utilization, for example.

Speaker Change: Yes, I think it's been.

Speaker Change: Relatively quiet in the context of the impact there's probably.

Speaker Change: A modest benefit to the <unk> side of our business has some surgeons or practices have reevaluated the tools that are being deployed based.

Speaker Change: Based upon the objective data that sits behind those tools, but I think it's a much smaller a negligible impact in the quarter versus as we spent a lot of time here talking about the growing standalone utilization for example.

Joseph E. Gilliam: As we go forward, it's status quo for now. The MAC's next steps and the timing remain unclear. But as we've said before, we do expect to hear from them again. And that stance is really unchanged. And so, as always, as has been the case historically, we'll continue to support the right of physicians to make clinical decisions on behalf of their patients if and when we see something from these MACs.

Speaker Change: As we go forward, it's status quo for now.

Speaker Change: The Mac next steps and the timing remain.

Speaker Change: Unclear, but as we've said before we do expect to hear from them again.

Speaker Change: And that stance is really unchanged and so as always been the case historically, we will continue to support the writers the physicians to make clinical decisions on behalf of their patients.

Steven Lichtman: And when we see something from from the Max.

Joseph E. Gilliam: And Joe, just quickly on OPEX, should we still target about 10% growth year over year this year?

Speaker Change: Got it and Joe just quickly on Opex should we still target about 10% growth year over year. This year.

Alex R. Thurman: Hey, Steve, it's Alex. I'll take that one. And thanks for the question. The answer is yes. I think the easiest way to think about it is from the start. Over the next three quarters, you should think of some kind of reasonable sequential increases over time so that you land at the year at about a 10% growth in OPEX compared to the base in 2023, which was 360 excluding IPR.

Speaker Change: Hey, Steve It's Alex I'll take that one and thanks for the question. The answer is yes, I think the easiest way to think about it is from from over the next three quarters, you should think of some kind of reasonable sequential increases over time that you landed the year at about a 10% growth in opex compared to the base.

Steven Lichtman: In 2023, which was $3 60, excluding IP R&D.

Steven Lichtman: Yeah.

Unknown Executive: Our final question will come from the line of Michael... Our final question will come from the line of Michael Sarcone with Jeffries. Please go ahead.

Steven Lichtman: Our final question will come from the line of Michael <unk>.

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

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

Michael Sarcone: Good afternoon, and thanks for squeezing me in here.

Michael Sarcone: Just.

Michael Sarcone: Another follow up on Idose.

Michael Sarcone: Going back through the first few years of the initial <unk> launch I know you talked about.

Michael Sarcone: A year or two where you did 700, new reps trained you also often talked about I guess in 2015.

Michael Sarcone: The average Rep training three surgeons per quarter. If you think about it kind of along those metrics do you expect that the average rep today could train.

Michael Sarcone: More surgeons than that given that a lot of these surgeons are already trained in open angle procedures or would it be something less than that because maybe they have more products in the bag to sell just wanted to get your thoughts on how youre thinking about that metric.

Joseph E. Gilliam: Well, I think you've largely framed it the right way, and so that's why I'm a little bit hesitant to get too specific on the pace of that training. But the tailwind from a comfortable standpoint is that, as you alluded to, we're not training the majority of these surgeons on angle-based surgery.

Speaker Change: Well I think <unk> SKU largely framed it the right way and so that's why I'm, a little bit hesitant to get too specific on the pace of that training.

Speaker Change: I'll call it the tailwind from a comparable standpoint is that as you alluded to we're not training. The majority of these surgeons on angle based surgeries. So from that standpoint, some of the harder elements of that training.

Joseph E. Gilliam: So from that standpoint, some of the harder elements of that training don't have to spend as much time on. The offset to that is exactly what you said, in that, you know, we're not just simply launching a single product here. In the case of Eidos, we have a portfolio; there's a lot of activity around ICE and Infinite. And so, you know, I think we'll have to feel our way through as the reps start hitting their full stride in terms of Eidos training and onboarding as we, you know, kind of exit this year and go into next year. And we'll provide a little bit more context for that, you know, I think context to that as we refine our own expectations.

Speaker Change: We don't have to spend as much time on that.

Speaker Change: The offset to that is exactly what you said in that.

Michael Sarcone: We're not just simply launching a single product here in the case of Idose, we have a portfolio theres a lot of activity around istent infinite.

Michael Sarcone: And so.

Michael Sarcone: We will have to feel our way through and as the reps start hitting their full stride in terms of idose.

Michael Sarcone: Training and Onboarding.

Michael Sarcone: As we kind of exit this year go into next year, and we'll provide a little bit more I think context to that as we refine our own expectations.

Michael Sarcone: Understood. Thanks. And just one quick one.

Speaker Change: Understood Thanks, and just.

Speaker Change: One quick one.

Speaker Change: You talked about.

Speaker Change: Commencing early initiatives to secure commercial coverage for Idose didn't give us a download on.

Speaker Change: Any types of conversations you're having in these early days with commercial payers and with the feedback and receptivity.

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

Joseph E. Gilliam: You talked about, you know, you're commencing early initiatives to secure commercial coverage for IDOS. If you can give us a download on, you know, any types of conversations you're having in these early days with commercial payers and what the feedback and or receptivity is, yeah, those efforts are really just beginning.

Speaker Change: Yes, those efforts are really just beginning.

Speaker Change: But there are a lot of conversations going on in fact, there is actually a fair number of policies that have already been issued out there even though we're not commercially trying to drive that side coverage has starting to turn on in a variety of the commercial payer and other settings.

Speaker Change: Round that I think to date, what you've seen from those policies is and exactly what wed expect and quite frankly, not all that dissimilar than if you look at the coverage policies that are out there for Arista.

Speaker Change: Today of which there are there are plenty so in terms of the interventional procedural pharmaceutical approaches.

Speaker Change: I think the payer community. Thus far has been following the playbook that they established.

Speaker Change: With tourists as they can.

Speaker Change: Think about that coverage for Friday STR.

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

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

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

Speaker Change: Okay I want to thank all of you for your time and attention today.

Speaker Change: We continue to thank you for your continued interest and support of glucose with that goodbye.

Speaker Change: Okay.

Unknown Executive: That will conclude today's call. Thank you all for joining. You may now disconnect.

Speaker Change: And that will conclude today's call. Thank you all for joining you may now disconnect.

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