Q4 2023 Glaukos Corp Earnings Call
Welcome to the Gulf Coast Corporation's fourth quarter, and full year 2023 financial results Conference call.
Operator: Welcome to the Glaukos Corporation's fourth quarter and full year 2023 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.
Copies of the company's press release and quarterly summary document both issued after the market close today are available at Www Dot glaucoma Dot com.
All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press the star key followed by the number one on your telephone keypad.
Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star 1. 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. Please go ahead. Thank you, and good afternoon.
If you would like 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 Dot glaucoma Dot com.
I will now turn the call over to Chris Lewis, Vice President of Investor Relations and corporate Affairs. Please go ahead.
Chris Lewis: Thank you and good afternoon, joining me today are Bob Who's Chairman and CEO, Tom Burns, President and CEO, Joe Gilliam and CFO Alex.
Chris Lewis: Joining me today are Glaukos Chairman and CEO Tom Burns, President and CEO Joe Gilliam, and CFO Alex Thurm. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key facts associated with the quarter, the state of the company's business objectives and strategies, and any forward statements or guidance we may make. This document is designed to be read by investors before the regularly scheduled quarterly conference call. As such, for this call, we will make brief prepared remarks and transition into a question and answer session. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow-up. If you still have additional questions, you may get back into the queue.
In order to prior quarters. The company has posted a document on its investor relations website under the financials and filings quarterly results section quarterly summary.
Chris Lewis: Document is designed to provide the investment community with the summarized and easily accessible reference document details the key tax associated with the quarter.
Chris Lewis: The company's business objectives, and strategies and any forward statements or guidance, we may make.
Chris Lewis: Document 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 into a question and answer session.
Chris Lewis: Your ample time and opportunity to address everyone's questions. We request that you limit yourself to one question and one follow up.
Chris Lewis: You still have additional questions you may get back into the queue.
Chris 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, US and international commercialization, market development efforts, the efficacy of our current and future products, competitive market position, regulatory strategies, and reimbursement for our products, financial condition, and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations, on our business and operations. For more information, visit www. FEMA.gov These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment, all of which are difficult to predict, and many of which are beyond our control. Therefore, it may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor section of our website at www.glaukos.com.
Chris Lewis: Please note that all statements other than statements of historical facts made on this call unaddressed activities or developments. We expect believe anticipate will or may occur in the future are forward looking statements.
Chris Lewis: Statements about our plans objectives strategies and prospects regarding among other things our sales products pipeline technologies and clinical trials U S and international commercialization market development efforts, the efficacy of our current and future products competitive market position regulatory strategy reimbursement for our products.
Chris Lewis: 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.
Chris Lewis: These statements are based on current expectations about future events affecting us.
And are subject to risks uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward looking statements.
Chris Lewis: Review today's press release, and our recent SEC filings for more information about these risk factors you'll find these documents in the investors section of our website at Www Costar com.
Chris Lewis: Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency in 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 the most directly comparable gap financial net.
Chris Lewis: Finally, please note that during today's call. We will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into glad because it's ongoing results of operations, particularly when comparing underlying results from Gary.
Chris Lewis: Please refer to the tables in our earnings press release available on the Investor Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure with that I will turn the call over to <unk>, Chairman and CEO Tom Burns.
Thomas William Burns: With that, I will turn the call over to Glaukos Chairman and CEO, Tom Burns. Okay, thank you, Chris. Good afternoon, and thank you all for joining us today. Glaukos reported today record fourth quarter consolidated net sales of $82.4 million, up 16% on a reported basis and 15% on a constant currency basis versus the year-ago quarter.
Thomas William Burns: Okay. Thank you Chris good afternoon, and thank you all for joining us today.
Thomas William Burns: Golf Coast reported today record fourth quarter consolidated net sales of $82 4 million up 16% on a reported basis and 15% on a constant currency basis versus the year ago quarter.
Thomas William Burns: For the full year 2023, consolidated net sales of nearly $315 million grew 11% on a reported basis and 12% on a constant currency basis versus 2022. We are also reaffirming our full year 2024 net sales guidance range of $350 to $360 million. These record results, which further exceeded our preliminary pre-announcement from early January, were driven by broad-based, double-digit growth across our glaucoma and corneal health franchises globally. Our strong four-quarter performance caps off a successful year of execution, both from a commercial and development perspective, leaving us ideally positioned as we enter into what should be a transformative period for our company in the years to come. From a commercial perspective, strong execution of key strategies within each of our core franchises drove a solid performance.
Thomas William Burns: For the full year of 2023 consolidated net sales of nearly $315 million.
Thomas William Burns: 11% on a reported basis and 12% on a constant currency basis versus 2022, we.
Thomas William Burns: We are also reaffirming our full year 2024, net sales guidance range of $350 million to $360 million.
Thomas William Burns: These record results, which further exceeded our preliminary pre announcement from early January were driven by broad based double digit growth across our glaucoma and corneal health franchises globally.
Thomas William Burns: Our strong fourth quarter performance capped off a successful year of execution, both from a commercial and development perspective, leaving us ideally positioned as we enter into what should be a transformative period for our company in the years to come.
Thomas William Burns: From a commercial perspective stronger execution of key strategies within each of our core franchises drove the solid performance within our U S. Glaucoma franchise, we delivered sales of $38 7 million a growth of 10% year over year, driven primarily by the continued commercial rollout of Istent infinite.
Thomas William Burns: Within our U.S. Glaucoma franchise, we delivered sales of $38.7 million on growth of 10% year-over-year, driven primarily by the continued commercial rollout of Isun Infinite. Market receptivity and adoption of iStent Infinite remain strong, with surgeon feedback most commonly highlighting the benefits of its three-step solution, favorable safety profile, and streamlined injector system. Alongside our commercial efforts, we also continue to advance key market access initiatives for Iceland Infinite with all MACs covering on a case-by-case basis, including two with LCAs in place. We will continue to monitor the various MAC processes and policies as we remain supportive of expanding broad access to interventional glaucoma tools for physicians and for patients. Moving on, our international glaucoma franchise delivered sales of $21.9 million on strong year-over-year growth of 25% on a reported basis and 23% on a constant currency basis.
Thomas William Burns: Market receptivity and adoption of Istent infinite remains strong.
Thomas William Burns: Surgeon feedback most commonly highlighting the benefits of its <unk> solution favorable safety profile and streamlined injector system.
Thomas William Burns: Alongside our commercial efforts. We also continued to advance key market access initiatives for Istent infinite with all Macs covering on a case by case basis, including two with LCA has in place.
Thomas William Burns: We will continue to monitor the various Mac processes and policies as we remain supportive of expanding broad access to interventional glaucoma tools for physicians and for patients.
Thomas William Burns: Moving on our international Glaucoma franchise delivered sales of $21 9 million on strong year over year growth of 25% on a reported basis and 23% on a constant currency basis.
Thomas William Burns: This strong growth was once again again broad based as we continued to scale our international infrastructure.
Thomas William Burns: And execute our plans to drive mix forward as the standard of care in each region region in every major market in the world.
Thomas William Burns: And finally, our corneal health franchise delivered record sales of $21 8, million% to 19% year over year growth, including for trucks, a record sales of $19 2 million on a year over year growth of 26% as our key initiatives continued to take hold in support of this important business.
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 MIGs forward as the standard of care in each region and every major market in the world. And finally, our corneal health franchise delivered record sales of $21.8 million on 19% year-over-year growth, including Vertrexa record sales of $19.2 million on a year-over-year growth of 26%, as our key initiatives continue to take hold in support of this important. Shifting gears to the development front, as you know, during the fourth quarter, we were delighted to announce FDA approval of IDOS-TR, a revolutionary microinvasive injectable therapy designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Ito's TR is a first-of-its-kind intracameral procedure pharmaceutical designed to deliver glaucoma drug therapy for up to three years.
Thomas William Burns: Shifting gears in the development front as you know during the fourth quarter, we were delighted to announce FDA approval of the Idose TR, a revolutionary micro invasive injectable therapy designed to lower intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Thomas William Burns: Idose TR is a first of its kind <unk> camera procedure pharmaceutical to design to deliver glaucoma drug therapy for up to three years.
Thomas William Burns: Following approval our teams have been hard at work executing the initial phases of our detailed coordinated launch plan.
Thomas William Burns: In conjunction with these efforts we're pleased to announce that just last week multiple surgeons successfully completed their first commercial cases of Idose TR.
Speaker Change: Nothing to report all of these cases went extremely well.
Speaker Change: Early feedback from the small group of surgeons has been very positive.
Speaker Change: Looking ahead, we plan to continue advancing a methodical controlled launch over the first half of 2024.
Speaker Change: Very focused on surgeon training and establishing market access.
Thomas William Burns: Following approval, our teams have been hard at work executing the initial phases of our detailed, coordinated launch plan. In conjunction with these efforts, we're pleased to announce that just last week, multiple surgeons successfully completed their first commercial cases of INOS-TR. We're happy to report that all of these cases went extremely well, and early feedback from the small group of surgeons has been very positive.
Speaker Change: As we refine and optimize our training and skill transfer to our sales force and surgical community.
Speaker Change: <unk> to expand our training and broader launch efforts efforts over the course of 2024.
Speaker Change: We are in a powerful position to leverage our established best in class.
Speaker Change: <unk> sales force and commercial organization to drive the Idose launch speaking of which earlier. This month, we held our global sales meetings, where most of the focus here in the U S was an istent infinite and Idose TR.
Speaker Change: It was evident throughout the productive meeting that our glaucoma sales force is excited and prepared to execute our plan.
Thomas William Burns: Looking ahead, we plan to continue advancing a methodical control launch over the first half of 2024 with a primary focus on surgeon training and establishing market access. As we refine and optimize our training and skill transfer to our sales force and surgical community, we will continue to expand our training and broader launch efforts over the course of 2024. We are in a powerful position to leverage our established best-in-class Glaucoma sales force and commercial organization to drive the Eidos launch. Speaking of which, earlier this month, we held our global sales meeting, where most of the focus here in the U.S. was on ICE and Infinite and IDOS-TR. It was evident throughout the productive meeting that our Glaucoma sales force is excited and prepared to execute our plan.
Speaker Change: Alongside that we are progressing several market access reimbursement initiatives designed to drive fulsome coverage and payment for the Idose TR procedural pharmaceutical overtime.
Speaker Change: First we successfully submitted our permanent J code application in late December which should allow for it to become effective in the second half of 2024 based on the CMS cycle for J codes.
Speaker Change: Then we are launching Idose TR with a temporary miscellaneous C code and anticipate measured adoption over this initial period until the permanent J code is in place and we've expanded our surgeon training initiatives.
Speaker Change: Next we're working to establish payment for the new category III code, one <unk> six zero T that will cover the procedural component of Idose TR.
Speaker Change: This includes the establishment of the facility fee through an APC classification from CMS, which we expect to become effective April one.
Thomas William Burns: Alongside that, we are progressing several market access reimbursement initiatives designed to drive fulsome coverage and payment for the IRS PR procedure for pharmaceuticals over time. On that front, first, we successfully submitted our permanent J code application in late December, which should allow for it to become effective in the second half of 2024 based on the CMS cycle for J codes. Until then, we are launching IDOS-PR with a temporary miscellaneous C-code and anticipate measured adoption over this initial period until the permanent J-code is in place and we've expanded our surgeon training initiative. Next, we're working to establish payment for the new Category 3 code, 0660T, that will cover the procedural component of EIDOS-TR. This includes the establishment of a facility fee through an APC classification from CMS, which we expect to become effective on April 1st.
Speaker Change: We will also be working with Max to secure professional fee coverage and payment over the course of 2024.
Speaker Change: Finally, our Idose TR commercial launch will be supported by a robust set of peer reviewed literature.
Speaker Change: During the fourth quarter. The first Idose TR publication was published in the journal drugs summarizes the phase to be three year outcomes.
Speaker Change: More recently, another tier manuscript published in ophthalmology and therapy highlighted favorable phase III 12 month results.
Speaker Change: Looking ahead there are in.
Speaker Change: Additional 10 articles to be published planned to be published in leading journals, including a manuscript that was just accepted by ophthalmology, which highlights high doses Trs phase III three months results.
Speaker Change: So to summarize the response, we received from surgeons with broader ophthalmic community since we announced FDA approval for Idose TR 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.
Thomas William Burns: We will also be working with MACS to secure professional fee coverage and payment over the course of 2024. Finally, our IDOES-PR commercial launch will be supported by a robust set of peer-reviewed literature. During the fourth quarter, the first IDOS-TL publication was published in the journal Drugs and summarizes the Phase 2b three-year outcome.
Speaker Change: A day.
Speaker Change: We are excited to now be in the initial phases of bringing this transformative technology to market and in doing so expanding the treatment alternatives for patients suffering with glaucoma and ocular hypertension.
Speaker Change: Beyond Idose, we continue to prudently invest in and successfully advance our robust pipeline of novel promising platform technologies that we believe have the abilities to significantly expand our addressable markets and to fundamentally transform our company over time.
Thomas William Burns: More recently, another TR manuscript published in Ophthalmology and Therapy highlighted favorable Phase III 12-month results. Look ahead. There are an additional 10 articles to be published, planned to be published in leading journals, including a manuscript that was just accepted by Ophthalmology, which highlights iDOSIS-PR's Phase III three-month results. So, to summarize, the response we have received from surgeons in the broader ophthalmic community since we announced FDA approval for IOST-TR has been overwhelmingly positive and reaffirms our view that, with the launch of We're excited to now be in the initial phases of bringing this transformative technology to market and, in doing so, expanding the treatment alternatives for patients suffering with glaucoma and oculohypertension.
Speaker Change: This includes at the OXXO, our next generation corneal cross linking therapy for which we continue to progress towards trial completion in the second phase III pivotal study and remain on track for data readout in the second half of this year supporting our targeted NDA submission by the end of 2024.
Speaker Change: In terms of our earlier stage pipeline, we commenced three new clinical trials during the fourth quarter of 2023, including.
Speaker Change: One a PMA clinical trial or istent infinite and mild to moderate glaucoma patients.
Speaker Change: A phase Iia study for <unk> Travoprost.
Speaker Change: <unk> first in human clinical development program for <unk> hundred one our <unk> multi kinase inhibitor retinal program in wet AMD patients.
Speaker Change: In 2024 will continue to drive our robust pipeline forward with additional plans which include.
Speaker Change: Commencing a U S IDE trial for the presser flow of Microsoft's.
Thomas William Burns: Beyond Eidos, we continue to prudently invest in and successfully advance our robust pipeline of novel, promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. This includes Epioxa, our next generation corneal cross-linking therapy for which we continue to progress towards trial completion in the second phase three pivotal study and remain on track for data readout in the second half of this year, supporting our targeted NDA submission by the end of 2024. In terms of our earlier stage pipeline, we commenced three new clinical trials during the fourth quarter of 2023, including a PMA clinical trial for IceStat Infinite and mild to moderate glaucoma patients. Two, a Phase IIa study for Eilushin-Travoprost, and three, a first-in-human clinical development program for GLK-401, our intravitreal multikinase inhibitor retinal program in wet AMD patients.
Speaker Change: Commencing a phase III study for Idose T Rex or next generation Idose therapy.
Speaker Change: Finally, completing enrollment in our phase III trials for our.
Speaker Change: Third generation therapy.
Speaker Change: So as you can see.
Speaker Change: We have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create at.
Speaker Change: At the same time as we've discussed we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk based spending and our capital position now and in the future.
In conclusion, I think its heading to remind you of our company mantra will go <unk>, which for US is more than just a company tagline rather than something that defines who we are as an organization and how we lead every day.
Speaker Change: We are ready to deliver in 2024 and beyond as we execute our commercial launch plans for Idose TR, along with Istent infinite.
Speaker Change: Our foundation is strong and we are ideally positioned to continue transforming vision for the benefit of patients worldwide.
Speaker Change: So with that I'll open the call to questions operator.
Speaker Change: Thank you at this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.
Thomas William Burns: In 2024, we'll continue to drive a robust pipeline forward with additional plans that include commencing a U.S. ID trial for the Pressure Flow Microshumps and initiating a phase 3 study for IDOS-T-Rex, our next generation IDOS therapy. And finally, completing enrollment in our phase 2 trials for our ILINK third generation therapy. So, as you can see, we have a lot to be excited about when it comes to the significant potential value that we believe our pipeline programs may create. At the same time, as we've discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending and our capital position now and in the future. In conclusion, I think it's fitting to remind you of our company mantra, We'll Go First, which is more than just a company tagline. Rather, it's something that defines who we are as an organization and how we lead every day.
Tom Stephen: We will go first to Tom's Stephen at Stifel.
Tom Stephen: Great Hey, guys. Thanks for the questions, maybe I'll start with guidance.
Tom Stephen: Joe or Alex any framework you can provide on how much of Idose is factored into 2020 for guidance.
Tom Stephen: And also what are some of the key inputs supporting that outlook.
Tom Stephen: Sure Hey, Thomas It's Joe I'll start off the balance sheet to add some color he can.
Alex: Maybe maybe first I'll start from a macro perspective on the guidance itself. I mean, obviously, we were we're pleased to see the business continue to deliver in the momentum as we exited 2023, we're entering 2024 and <unk>.
Alex: And I think the guidance we established overall.
Alex: Really implies another year of accelerating growth as we focused on putting in place.
Alex: The foundational building blocks that we believe will enable the next decade of growth for our company.
Operator: We are ready to deliver in 2024 and beyond as we execute our commercial launch plans for ITOS-TR, along with iSpin Infinite. Our foundation is strong, and we are ideally positioned to continue transforming vision for the benefit of patients worldwide. So with that, I'll open the call for questions. Operator.
Alex: I've said this I think on one of the calls either around the Investor Conference earlier this year or in December when we first gave guidance there are a variety of.
Alex: Scenarios and drivers for our business in 2024, and even within the U S glaucoma franchise of which.
Operator: Thank you. At this time, I would like to remind everyone in order to ask a question, press star then the number one on your telephone keypad. We'll go first to Thomas. Stephen, at... Great. Hey, guys, thanks for the questions. Maybe I'll start with Guy.
Alex: <unk> is really one of those and so.
Alex: I think certainly acknowledge and respect the importance of trying to dive a little bit deeper on the specificity around the numbers associated with Idose I think it's a little early to get too granular there.
Alex: Clearly, it's going to be increasingly material driver as we make our way through the year and certainly as we enter 2025.
Joseph E. Gilliam: Joe or Alex, you know, any framework you can provide on how much of IDOS is factored into 2024 guidance, and then also, what are some of the key points supporting that? Sure. Hey, Tom, it's Joe. I'll start off by saying if Alex would be able to color, he can.
At some point here in the coming quarters, we'll provide additional disclosure on the actual revenues of Idose as we really transition from as Tom said that the early access phase into a into a full launch.
Alex: Okay.
Speaker Change: Got it makes sense Thats fair and then just on the Idose label.
Joseph E. Gilliam: You know, maybe first I'll just start from a macro perspective on the guidance itself. I mean, obviously, we were pleased to see the business continue to deliver and the momentum as we exited 2023 and now enter 2024. And I think that the guidance we established overall really implies another year of accelerating growth as we focused on putting in place really the foundational building blocks that we believe will enable the next decade of growth for our company. You know, I said this on one of the calls, either around the investor conference earlier this year or in December when we first gave guidance. You know, there are a variety of scenarios and drivers for our business in 2024, and even within the U.S. Glaucoma franchise, of which, you know, Eidos is really one of those. And so, I certainly acknowledge and respect the importance of trying to dive a little bit deeper on the specificity around the numbers associated with Eidos.
Speaker Change: <unk> only been a couple of months since approval by Tom any updates on the label as it relates to single administration have you been able to gather I guess any additional color from FDA on their decision.
Speaker Change: And then maybe more importantly, what the path forward for <unk> from here in that regards thanks for taking the questions.
Speaker Change: Yes, Tom be happy to answer and so let me first say that we are poised for success today given the current label.
Speaker Change: Even with the current limitation and all our channel checks with R. R.
Speaker Change: Missions and surgeons, we see no impediments to the appetite for the use of the Iqos product and so that's very encouraging but to answer your question directly we're in the process of re repositioning to the FDA for re administration.
Speaker Change: The idose device and as Youre, probably aware within Cedar right now the drug Division there is a changing of the guard and so we're waiting for that transition to happen and the dust to settle and then we will put our competition before that cohort and we're hopeful for a successful conclusion in the event that we're not remember that we already have.
Speaker Change: Idose T Rex, which again contains approximately twice the amount of medication of the Idose. That's planned to enter a clinical trial by the end of the year.
Joseph E. Gilliam: I think it's a little early to get too granular there, but clearly, it's going to be an increasingly material driver as we make our way through the year and certainly as we enter 2025. And at some point in the coming quarters, we'll provide additional disclosure on the actual revenues of Eidos as we really transition from, as Tom said, the early access phase into a full launch.
Speaker Change: And so by our best thinking we're targeting a commercial approval for that product in 2028. So if you think about it.
Speaker Change: The Idose T Rex could become the next reimplantation product for our current Idose.
Speaker Change: Products and initiatives. So I feel like were recovered in all respects I feel good about our path forward, we're hopeful to be successful repositioning the FDA, we have a sophisticated.
Thomas William Burns: Makes sense, that's fair. And then just on the high-dose label, no, it's only been a couple months since approval, but Tom, any updates on the label as it relates to single administration? Have you been able to gather, I guess, any additional color from FDA on their decision? And then, maybe more importantly, what the path forward for Glaukos is from here in that regard? Thanks for taking the question. Yeah, Tom, I'll be happy to answer it.
Argument to make to them, but having said that were covered in either event.
Speaker Change: Very helpful. Thanks, Tom.
Speaker Change: Youre welcome Thanks, Tom.
Speaker Change: We will go next to Ryan Zimmerman of <unk>.
Ryan Zimmerman: Alright, I'm going to try and ask a similar question on Idose in a different way.
Press My luck here, a little bit but.
Ryan Zimmerman: When you talk about the controlled launch guys.
Ryan Zimmerman: What does that mean, how many surgeons.
Ryan Zimmerman: Are you trying to get comfortable with with an idose at what point do you transition to a broader launch.
Thomas William Burns: And so let me first say that we're poised for success today, given the current label. Even with the current limitation, in all our channel checks with our clinicians and surgeons, we see no impediment to the appetite for the use of the iDOS product, and so that's very encouraging. But to answer your question directly, we're in the process of re-petitioning to the FDA for re-administration of the iDOS device. And as you're probably aware, within CDER right now, the drug division, there's a changing of the guard. And so we're waiting for that transition to happen and the dust to settle, and then we'll put our petition before that court.
Ryan Zimmerman: Regardless of maybe the reimbursement milestones that are up ahead, just to help us kind of frame.
Ryan Zimmerman: How much experience.
Ryan Zimmerman: Looking for.
Ryan Zimmerman: Idose initially.
Ryan Zimmerman: Hey, Brian Fitzgerald, we'll try not to have you could have had a whammy here, but I will give you a little bit of color around kind of where we're at where we're going I hopefully it's consistent with what we talked about during the original.
Ryan Zimmerman: Approval call.
Right now we're officially in the early access phase.
Ryan Zimmerman: The launch and.
Ryan Zimmerman: The Great news as Tom mentioned in the prepared remarks, we now have the first procedures, having been completed last week as a part of that that's a big step organizationally or through our national sales meeting and we've begun that early access phase with a handful of docs.
Thomas William Burns: And we're hopeful for a successful conclusion. In the event that we're not, remember that we already have IDOS-T-Rex, which again contains approximately twice the amount of medication of IDOS that's planned to enter a clinical trial by the end of the year. And so, by our best thinking, we're targeting a commercial approval for that product in 2028. So if you think about it, the IDOS-T-Rex could become the next re-implantation product for our current IDOS products and initiatives. So I feel like we're covered in all respects. I feel good about our path forward. We're hopeful to be successful at re-petitioning the FDA. We have a sophisticated argument to make to them. But having said that, we're covered in either appearance. Very helpful. You're welcome. Thanks, Tom. We'll go next to Ryan Zimmerman at BTIG.
Ryan Zimmerman: And I think it's important to note that it is limited in scope. The goal of that early access phase is really designed to help us refine our trading algorithms and established confidence within our sales force and iron out.
Ryan Zimmerman: Any early market access challenges that inevitably come with a product launch like this we will transition in the coming months to a broader launch, but like we've said in the past that really goes from crawling to walking the jogging running.
Ryan Zimmerman: Objective there is that as we move into those early early launch phase that we've got all of our reps out.
Ryan Zimmerman: <unk> with their starter cases trading one maybe two doctors at the beginning and then as they continue to refine their algorithms and their experience.
Operator: Alright, I'm going to try and ask a similar question on iDose in a different way. I'm going to lock this up for a little bit. You know, when you talk about the controlled launch, guys... What does that mean? How many searches?
Ryan Zimmerman: But that up more broadly as we get into the second half.
Ryan Zimmerman: It clearly as we've said before starts to hit our stride as you get into the fourth quarter and that's by design because it also happens to match up with where you expect the market access side of the equation to start to provide a little bit more clean path forward too as <unk> got a fully established J code, a published Asps and all the things that come alongside that so it really.
Joseph E. Gilliam: Are you trying to get comfortable with an eye dose at what point? Transition to a broader launch, regardless of maybe the reimbursement milestones that are up ahead, just to help us kind of frame. I don't know how much experience you're looking for............. Hey, Ryan, it's Joe.
Joseph E. Gilliam: We'll try not to have you hit a whammy here, but I will give you a little bit of color around kind of where we are, where we're going, and hopefully it's consistent with what we talked about during the original, you know, approval call. Right now, we're officially in the early access phase of the launch, and the great news is Tom mentioned the prepared remarks. We now have the first procedures having been completed last week as a part of that. That's a big step. You know, organizationally, we're through our national sales meeting. We've begun that early access phase with a handful of dollars.
Ryan Zimmerman: We'll be a somewhat I'll call. It linear release, if you will of our efforts between now and that fourth quarter timeframe, where we hope to start really running as we then sprint into 2025.
Ryan Zimmerman: Okay.
Speaker Change: Second question for me turning to Infineon.
Speaker Change: You guys are going to pursue a label expansion in mild to moderate patients how much of that how much is that a gating factor.
Do you think to adoption and current usage of <unk>.
Speaker Change: When are you thinking about how it's being used today.
Speaker Change: Where it can go.
Speaker Change: And then maybe kind of talk about it in the context of both combo cataract and also stand alone.
Joseph E. Gilliam: And I think it's important to note that it is limited in scope. The goal of that early access phase is really designed to help us refine our training algorithms and establish confidence within our sales force and iron out any early market access challenges that inevitably come with a product launch like this. We will transition in the coming months to a broader launch. But like we've said in the past, that really goes from, you know, crawling to walking to jogging to running.
Speaker Change: As you pursue that label.
Speaker Change: Yes, Ryan I am happy to address that so first of all let's talk about the study itself. So we're going to do a multicenter prospective study with.
We'll be looking at mean diurnal IOP reduction of greater than 20% from baseline to 12 months with a pre specified endpoints that we've negotiated with the FDA and so we feel like we're in a confident position.
Speaker Change: Targeting approval at the tail end of this clinical trial given the.
Speaker Change: Demonstrable performance, we've had with the product up to date.
Joseph E. Gilliam: The objective there is that as we move into the early, early launch phase, we've got all of our reps out starting with their starter cases, training one, maybe two doctors at the beginning. And then, as they continue to refine their algorithms and their experience, we'll open that up more broadly as we get into the second half. It clearly, as we've said before, starts to hit a stride as you get into the fourth quarter. And that's by design, because that also happens to match up with where you expect the market access side of the equation to start to provide a little bit more of a clean path forward, too, as you've got a fully established JCO to publish ASP and all the things that come alongside that.
Speaker Change: I think when we look at the marketplace and the Tam serially, we know that the current marketplace for patients who failed on surgical medical therapy, we're estimating at about 200000 patients right.
Speaker Change: So when we expand and we look at going to mild to moderate patients. We believe by our estimation is that we'll be looking at additional 400 to 500000 patients that we would recover by doing so so that in and of itself is an expression of how we.
Speaker Change: Intend to expand the market.
Speaker Change: I think the product will be used equally I think as we get these get.
Get the approvals so I think there'll be a strong initiative as we move forward with interventional glaucoma, where people will start to feel a strong confidence in using this in standalone cases, and certainly our upgrades of $5 493 of the EPC side doesn't hurt us as a financial incentive for surgeons to be doing the right therapy for their.
Thomas William Burns: So it really will be a somewhat linear release, if you will, of our efforts between now and that fourth quarter time frame, where we hope to start really running as we then sprint into 2025. Second question for me, turning to Infinite. You know, you guys are going to pursue a label expansion in mild to moderate. How much of that, how much is that a gating factor? What do you think about adoption?
Speaker Change: Ah patients.
Speaker Change: As well the combo cataract side. It makes sense was particularly when we have a broad label that surgeons will feel very comfortable down to the very early innings of glaucoma and using this product in combination with cataract surgery why wouldn't you do have <unk> versus <unk>. In this case that we've showed demonstrable additive effect.
Thomas William Burns: current usage of When you think about how it's being used today, where it can go, and maybe kind of talk about it in the context of both combo cataracts and also stand alone, as you pursue. Yeah, right. I'm happy to address that. So, first of all, let's talk about the study itself. So we're going to do a multicenter prospective study, which will be looking at a mean DRO ILP reduction of greater than 20% from baseline in 12 months, with a pre-specified endpoint that we've negotiated with the FDA. And so we feel like we're in a confident position of targeting approval at the tail end of this clinical trial, given the demonstrable performance we've had with the product up to date. I think when we look at the marketplace and the TAMs serially, we know that the current marketplace for patients who failed surgical medical therapy is estimated to be about 200,000 patients, right?
Speaker Change: With those different products.
Speaker Change: So I feel like that's the way this will come on in one of the things that I feel very strongly about is that overtime surgeons will begin to use istent infinite in conjunction with Idose.
Speaker Change: And so why do I say that because I stayed incident is showing a strong.
Speaker Change: <unk> ability to reestablish physiologic physiologic outflow through the trabecular meshwork Idose works on a different part of the <unk>.
Speaker Change: Squirrel system and so using these products in combination should provide a very robust competence Oreo appeared procedure therapy for surgeons as they move forward and we think that within the Medicare fee for service system. There is going to be no impediments. There are two separate CPT codes different mechanisms of action.
Speaker Change: And these are different product classes, and we can think about it 50% of patients right now that use topical meds are on tour medications, so combination therapy rules.
Speaker Change: Half of the current identified diagnosed glaucoma patients and so we think that this will be an extraordinary opportunity in combination therapy as we get into commercial payers and Medicare advantage there'll be some restrictions just like there is with standalone treatments with infinite and with Idose, but we're highly encouraged I love the double whammy of having both of these <unk>.
Thomas William Burns: And so when we expand and we look at going to mild to moderate patients, we believe, by our estimations, that we'll be looking at an additional 400,000 to 500,000 patients that we would be covering by doing so. So that in and of itself gives an indication of how we intend to expand the market. I think the product will be used equally.
Speaker Change: Rogers and catalysts, giving us the full curve to create the interventional glaucoma market space.
Speaker Change: Thanks, Tom Thank you for taking my questions.
Tom: Okay. Thanks, Brian.
Thomas William Burns: I think as we get these, get the approvals, I think there'll be a strong initiative as we move forward with interventional glaucoma, where people will start to feel strong confidence in using this in standalone cases. And certainly, our upgrade to 5493 on the APC side doesn't hurt us as a financial incentive for surgeons to be doing the right therapy for their patients. I think as well, on the convo cataract side, it makes sense, particularly when we have a broad label, that surgeons will feel very comfortable down to the very early innings of glaucoma in using this product in combination with cataract surgery. Why wouldn't they?
Tom: We will take our next question from Larry <unk> Olson at Wells Fargo.
Larry Olson: Hey, guys. Thanks for taking the question.
Larry Olson: Tom starting up on Idose.
Obviously the asps.
Larry Olson: Got a lot of attention when you announced it love to hear from you the reaction from any payers or physicians.
Larry Olson: Your confidence that you've prices.
Speaker Change: Prices right and then just secondly youre.
Speaker Change: You are confident that the surgeon fee.
Speaker Change: He is going to be is it going to be adequate and I had one follow up.
Speaker Change: Yes, I'd be happy to address that Larry So as you know we did our homework over the last couple of years, we've done multiple pharmacogenomics.
Speaker Change: Different approaches to the treatment of glaucoma and using the Idose therapy with John we've done Mark cause transition probability analysis, we met with payer groups, we licensed and looked at.
Thomas William Burns: You have three stents versus two stents in this case, and we showed a demonstrable additive effect with those different products. So I feel like that's the way this will come out. And one of the things that I feel very strongly about is that over time, surgeons will begin to use the term "I spent an infinite amount of money" in conjunction with "I don't." And so, why do I say that? Because Ice Thin Infinite is showing a strong ability to re-establish physiologic outflow through the trabecular meshwork, iDose works on a different part of the eye, the uveoscleral system.
Speaker Change: An external group to be able to go out to payers and pre talk about the pricing of this product, although we didn't disclose what product. It was but we talked about the nature of the attributes and we are getting positive signals across the board and so the short answer to your question is once we look at and show surgeons where the.
Speaker Change: Procedural pharmaceutical lines up.
Thomas William Burns: And so, using these products in combination should provide a very robust, combinatorial, paired-procedure therapy for surgeons as they move forward. And we think that within the Medicare fee-for-service system, there's going to be no impediments. There are two separate CPT codes, different mechanisms of action, and these are different product classes.
Speaker Change: Given the other procedural pharmaceuticals that have been available and quantified within ophthalmology. The scores are very well somewhere in the median of those products as you know <unk>, which is the three year steroid implants used for the treatment of uveitis costs on the order of 18 to $19000, we know that the Arista.
Thomas William Burns: And when you think about it, 50% of patients right now that use topical meds are on two or more medications. So, combination therapy rules for half of the current identified diagnosed glaucoma patients. And so, we think that this will be an extraordinary opportunity for combination therapy. As we get into commercial payers and Medicare Advantage, there will be some restrictions, just like there are with standalone treatments with Infinite and with iDose. But we're highly encouraged.
Speaker Change: <unk> is roughly $2000 for three to four months therapy and when you can say when you start to look at that over a three year period, you start to get quite comfortable everywhere I hope prescient and how we and how we price the products. So having said all of that the response of surgeons I think has been.
Speaker Change: Fulsome has been understanding I don't see that as an impediment as always as we move forward I think we're going to have open field running with Medicare fee for service I think as we get into the commercial and Medicare advantage patients certainly they will do the same thing they did with the Arista has some edits before year using this product, but I don't I don't know.
Thomas William Burns: I love the double whammy of having both these harbingers and catalysts giving us the fulcrum to create the interventional glaucoma market space. Thanks, Tom. Thank you for taking questions. Okay, thanks Ryan. We'll take our next question from Larry Biegelsen at Wells Fargo. Hey, guys.
Speaker Change: <unk> any impediments to utilization versus where we price the product I think we I think we hit it.
Speaker Change: Right sure.
Speaker Change: And the surgeon fee being adequate and I'll just ask.
My follow up Jeff what happened what happens next with the mix LCD or what's the assumption in the guidance.
Operator: Thanks for taking the question. Tom, starting off on iDose, obviously, the ASP got a lot of attention when you announced it, and I'd love to hear from you the reaction from, you know, any payers or physicians and, you know, your confidence that you've priced this right. And just secondly, your confidence that the escalating fee is going to be adequate. And I had one follow-up.
Jeff: What are you assuming.
Jeff: For infinite case by case is not probably what.
Jeff: Ideal for you and is there any turbulence in the market is still from.
From the noise from the LCD. Thanks.
Jeff: Well, let me let me address I didn't address your second question on proceeds let me do so before I turn it over to Joe.
Joe: We look at what's happening with Istent infinite, which is a very light procedure and we'd see a WPS in first coast at least the first numbers are coming in is certainly greater than 600.
Thomas William Burns: Yeah, I'd be happy to address that, Larry. So, as you know, we did our homework over the last couple of years. We've done multiple pharmacoeconomic different approaches to the treatment of glaucoma using the iDOS therapy. We've done Markov transition probability analysis.
Joe: And we know that cataract surgery right now average national payment is about $5 25.
Joe: I think we're going to I think and I'd like to believe we're going to settle somewhere in that range. Some of the ranges have been as high as $1000 in the early innings for Istent infinite and so.
Thomas William Burns: We met with payer groups. We licensed and looked at an external group to be able to go out to payers and pre-talk about the pricing of this product, although we didn't disclose what product it was, but we talked about the nature of the attributes, and we are getting positive signals across the board. And so the short answer to your question is once we look at and show surgeons where this procedural pharmaceutical lines up, given the other procedural pharmaceuticals that have been available and codified with that ophthalmology, this squares off very well, somewhere in the median of those products. As you know, Retin-A, which is a three-year steroid implant used for the treatment of uveitis, costs on the order of $1 We know that Dorista costs roughly $2,000 for a three- to four-month therapy, and when you amputate and start to look at that over a three-year period, you start to feel quite comfortable that we were, I hope, prescient in how we priced the product.
Joe: And as different Mac start to look at this procedure I think they're going to start to crosswalk. This over pretty similarly to what we see with lifestyle incident. So I wanted to answer your question before I turn it over to Joe.
Joe: Hey, Larry.
Joe: On the CD front I think this is one of those scenarios, obviously that we assess as we set the overall guidance and there's a range of outcomes there, perhaps less certainly less material than idose as you think about the drivers for 2024, but in general I think it's at this point largely status quo.
Joe: For now with perhaps an overlay of being cautious at the account level until more definitive clarity has established the next steps and the timing for Max map policy changes remains unclear at this point, but we do expect to hear from them again and in that regard our priorities really remain unchanged we're folk.
Joe: On protecting the rights of our customers to make clinical decisions on behalf of their site threatened patients, but but at this stage. We're in the wait and see gained 222 to determine where the Mexico next.
Speaker Change: Thanks, a lot.
Speaker Change: We'll go next to Matthew O'brien of Piper Sandler.
Thomas William Burns: So, having said all that, the response of surgeons, I think, has been fulsome and understanding. I don't see that as an impediment at all as we move forward. I think we're going to have an open field running with Medicare fee-for-service. I think as we get into commercial and Medicare Advantage patients, certainly they will do the same thing they did with Dorista, have some edits before you use this product, but I don't anticipate any impediments to utilization versus where we price the product. I think we hit it right where we should have hit it.
Matthew O'brien: Afternoon, Thanks for taking my questions.
Matthew O'brien: The street's modeling for Idose about 27 $28 million. This year is that number a good number too high too low in your opinion and then those first cases, where they bilateral or single cases, and then I do have a follow up.
Speaker Change: Sorry can you repeat that second part of the question of England.
Speaker Change: Hey, good luck.
Speaker Change: Yes, so I'll start with that.
All single cases.
Speaker Change: At the start here, which is what you would expect as a part of the <unk> launch.
Thomas William Burns: And the surgeon fee being adequate, I'll just ask my follow-up, what happens next with the MIGS LCD, or what's the assumption in the guidance? What are you assuming, you know, for Infinite, case by case, is not probably what, you know, ideal for you, and is there any turbulence in the market still from the noise from this LCD? Well, let me address your second question on pro-fee, so let me do so before I turn it over to Joe. If we look at what's happening with ICD-INF, which is a very light procedure, and we see at WPS and First Coast, at least, the first numbers are coming in. It's certainly greater than $600, and we know that cataract surgery right now costs about $525.
Speaker Change: As it relates to the Idose number.
Speaker Change: Stop short of commenting specifically on where the streets guidance does that maybe what I will do is provide a little bit more color and context around the franchises and their drivers.
Of our overall.
Speaker Change: Guidance I mean clearly the.
Speaker Change: U S glaucoma franchise moves.
Speaker Change: Front and center and why you guys are focused on that and ask a question around idose.
Speaker Change: Our focus there is going to continue to be driving forward first the interventional glaucoma mindset and within that trying to establish istent infinite and then driving the training and market access and early adoption with Idose internationally.
Joseph E. Gilliam: I think we're going to, and I think, and I'd like to believe we're going to settle somewhere in that range. Some of the ranges have been as high as $1,000 in the early innings for ICD-INF. And so, as different MACRAs start to look at this procedure, I think they're going to start to crosswalk this over pretty similarly to what we see with ICD-INF. So I wanted to answer your question before I turned it over to Joe. And Larry, on the LTD front, I think, you know, this is one of those scenarios that we assessed as we set the overall guidance, and there's a range of outcomes there, perhaps less, certainly less material than EIDOS, as you think about the drivers for 2024.
Speaker Change: This continues to scale as you saw in the fourth quarter.
Speaker Change: With that comes to market access head headwinds as government government payers.
Speaker Change: We seek to limit.
Speaker Change: Finishes as you scale, most recently you've seen that emerge in Switzerland. For example, we will see it elsewhere, we've seen in the past and will continue to experience that.
Speaker Change: In parallel we expect to see continued efforts by competition those markets and.
Speaker Change: And probably even a little bit of currency headwind as we sit here today going into the year.
Speaker Change: And on the cornea side, while we were very pleased with the growing momentum we saw in the fourth quarter will probably face some new headwinds in 2024.
Joseph E. Gilliam: But in general, I think it's, at this point, largely the status quo, at least for now, with perhaps an overlay of being, you know, cautious at the account level until more definitive clarity is established. The next steps and the timing for MAC policy changes remain unclear at this point, but we do expect to hear from them again. And in that regard, our priorities really remain unchanged.
Speaker Change: As some of you may be aware the $0 floor for Medicaid rebates expired on December 31.
Speaker Change: And with that we're going to see some incremental government rebates on a year over year basis, and we will probably also see some continued device related selling headwind is it that'd be oxyt gets increasingly in focus for both our customers and our sales force as you think about that Matt Directionally kind of where does that put us in the in the guidance range we gave.
Joseph E. Gilliam: We're focused on protecting the rights of our customers that make clinical decisions on behalf of their, you know, site-threatened patients. But at this stage, we're in the wait-and-see game, too, to determine, you know, where the MACs go. Thanks a lot.
Matt: I think that we're comfortable that the interventional glaucoma franchise should deliver kind of low ish double digit year over year growth for the year.
Operator: We'll go next to Matthew O'Brien at Piper Stanley. Afternoon. Thanks for taking the questions. You know, the street modeling for I-DOS is about $27, $28 million this year. Is that number a good number? Too high, too low, in your opinion?
Matt: The corneal health should deliver mid single digit year over year growth for the year.
Matt: Taking into consideration what I just mentioned and then ultimately that implies a U S. Glaucoma. Some high teens type growth, which is of course going to be weighted towards the back half of the year.
Joseph E. Gilliam: And then those first cases, were they bilateral or single eye? And then I do have a follow-up. Sorry, Matt, can you repeat that second part of the question? Stigle I. Oh, Stigle I. Yeah, follow that over.
Matt: So I think when you put all that together and maybe most importantly.
Matt: It points out accelerating trends within our overall franchises and what we think is a pretty strong exit velocity. If you will when you think about coming out of 2024 and into 2025, particularly within that U S glaucoma business.
Joseph E. Gilliam: Stigle I. Yeah, so I'll start with that. They were all single-eye cases at the start here, which used what you'd expect as a part of the IDOS launch. As it relates to the IDOS number, I'll stop short of commenting specifically on where the STREETS guidance is at. Maybe what I will do is provide a little bit more color and context around the franchises and their drivers of our overall guidance. I mean, clearly, the U.S. glaucoma franchise is moving front and center. It's why you guys are focused on that and asking questions around IDOS. You know, our focus there is going to continue to be driving forward first the interventional glaucoma mindset and within that, trying to establish ICDN Infinite and then driving training and market access and early adoption with IDOS, you know, internationally.
Matt: Yes.
Okay I appreciate that John and then that kind of dovetails into the next question you started covering all of this but.
Speaker Change: Youre defended I mean, that's that's a dramatic slowdown in the U S.
Speaker Change: Glaucoma business, excluding whenever revenues would come up with for Idose, and then kind of same thing O U S and I know youre talking about Sweden, but I don't think it's that big of a market maybe I'm wrong. So why why would be slow down that dramatically in many of these areas, especially Cardinal health, which has had a monster Q4.
Speaker Change: Yes, so I mean, I think I'd just start to cover that let me clarify a couple of things that you just said there I think in the context I won't repeat my my comments around some of the drivers there obviously in each of those businesses.
Speaker Change: I'll focus on what you said around the international the U S glaucoma side of things on the international side look if you continue to scale. It was Switzerland. It is not.
Joseph E. Gilliam: The business continues to scale, as you saw in the fourth quarter. But with that comes some market access headwinds as government payers really seek to limit expenditures as you scale. You know, most recently, we've seen that emerge in Switzerland, for example.
Speaker Change: The largest supply even our European markets, but it does matter when youre thinking about that growth dynamic when you bridge from the currency headwinds, we expect a couple of percent probably 2% ish at this point and you think about some of the competitive dynamics that continue to evolve out there combine that with what is a relatively difficult first half.
Joseph E. Gilliam: We'll see it elsewhere. We've seen it in the past. It will continue to do so. You know, in parallel, we expect to see continued efforts by competition in those markets and probably even a little bit of currency headwind as we sit here today going into the year. And on the cheesiest side, you know, while we were very pleased with the growing momentum we saw in the fourth quarter, we'll probably face some new headwinds in 2024. As some of you may be aware, the zero dollar floor for Medicaid rebates expired on December 31st.
Speaker Change: Comp if you go back and look at our international business. It was pretty clear that we were running at elevated levels in the first half of last year. Despite the continued growth tailed off a little bit from an absolute basis in the second half probably as procedures starting to normalize a bit.
Speaker Change: On a global basis in the second half so you have to factor those things in as.
Joseph E. Gilliam: And with that, we're going to see some incremental government rebates on a year-over-year basis. And we'll probably also see some continued device-related, you know, selling headwinds as Epioxide gets increasingly in focus for both our customers and our sales force. If you think about that, directionally, kind of where does that put us in the guidance range we gave?
Speaker Change: As it relates to the U S. Glaucoma I don't think I, followed that there in fact, if you implied from what I just said in terms of high teens growth for the year.
Speaker Change: Is that accelerating over the course of the year into the back half.
Speaker Change: That overall in any way you cut it is actually an accelerating performance, which is what you would expect with both the impact from Istent infinite as well as obviously idose coming into 'twenty 'twenty four.
Joseph E. Gilliam: I think that, you know, we're comfortable that the interventional glaucoma franchise should deliver kind of lowish double-digit year-over-year growth for the year. And that corneal health should deliver, you know, mid-single-digit year-over-year growth for the year, taking into consideration what I just mentioned. And then ultimately, that implies U.S. glaucoma, some high teens-type growth, which is, of course, going to be weighted towards the back half of the year. So I think, you know, as you put all that together, and maybe most importantly, it points out, you know, accelerating trends within, you know, our overall franchises. And, you know, what we think is a pretty strong exit loss, if you will, when you think about coming out of 2024 and into 2025, particularly within that U.S. Guantanamo business. Okay. I appreciate that, Joe.
Speaker Change: Yes.
Speaker Change: Okay, we can follow up offline. Thanks.
Speaker Change: Thanks Pat.
Speaker Change: We will go next to Mark Greg Hesler at William Blair.
Hey, good afternoon, guys. Thanks for taking the question.
Speaker Change: I wanted to maybe start I'll kind of give us again, sorry, I'm gonna be number five today on that but I wanted to see if theres any additional background.
Speaker Change: Surgery patient cohorts for these first few Idose cases are these patients have been waiting for a long time in the Q or the question time multiple idose procedures in a day or already in the ASC.
Speaker Change: Anything like that would be useful thank you.
Joe: Hi, Margaret it's Joe.
Joe: Obviously, it's a little early with these cases, having just started last week to draw any discernible trends I think that for majority of these patients I would say they are clearly standalone patients.
Joe: That.
Joe: No.
Joe: These early surgeons have deemed to be straightforward in the context of bringing them into the idose procedure.
Joe: Whether or not they were.
Joseph E. Gilliam: And then that kind of dovetails into the next question. You started covering all this in what you were just saying, but I mean, that's a dramatic slowdown in the U.S. of business, excluding, you know, whatever revenues would come up before I do. And then, kind of the same thing, OUS, and I know you're talking about Sweden, but I don't think it's that big of a market.
Joe: Obviously treated with different solutions, and maybe even an idose trial et cetera, historically there'll be a mix of that as we get going here.
Joe: But I think the most important thing there is is that the surgeons out of the gate are really focused on providing a standalone therapy and care for these for these patients.
Speaker Change: Okay fair enough.
Joseph E. Gilliam: So why would they slow down that dramatically in many of these areas, especially coronary health, which has had a monster. Yeah. So, I mean, I think I just started to cover that. Let me clarify a couple of things that you just said there. I think in the context, I won't repeat my comments about some of the drivers there, obviously, in each of those businesses. I'll focus on what you said about the international and U.S. glaucoma sides of things. On the international side, look, if you continue to scale, it was Switzerland's. It is not the largest, probably not even our European markets, but it does matter when you're thinking about that growth dynamic.
Speaker Change: And then I wanted to maybe move over to <unk>.
Speaker Change: <unk> submission by the end of the year and what's the vision for the product kind of your expectations on timing and level setting us maybe on the opportunity from a prevalence perspective plate procedure cost perspective et cetera.
Speaker Change: Yes, Margaret I'm happy to take that one and so as we said before the we'll have the results for the second phase III clinical trial by mid year, or so we will be preparing an NDA.
Speaker Change: We'll hope to be able to help.
Speaker Change: Publish those results just before we file our NDA with the FDA will look for a 10 month crew per day or thereabouts and will be approvable in the late part of 2025 and when you think about it that'd be OXXO as we've talked about before is a highly different procedure. The fact that I don't have to remove.
Joseph E. Gilliam: When you bridge the currency headwinds that we expect a couple of percent, probably two percent at this point, and you think about some of the competitive dynamics that continue to evolve out there, combine that with what is a relatively difficult first half comp. If you go back and look at our international business, it was pretty clear that we were running at elevated levels in the first half of last year. Despite the continued growth, it tailed off a little bit from an absolute basis in the second half, probably as procedures started to normalize a bit on a global basis in the second half. So, you have to factor each of those things in.
Speaker Change: The corneal epithelium to be able to perform the procedure is pretty extraordinary cornett epithelium, when it's removed does.
Speaker Change: <unk> somewhat visually rehabilitation that certainly is painful for the patient.
Speaker Change: And because of the extra time for visual rehabilitation.
Speaker Change: Times, it's incongruent with the young patients that are having this procedure, which sometimes have to defer the procedures until spring break or summer until they have a little bit more time to spend at home a deal. So we have the opportunity with <unk>, having a new formulation, which has the surfactant which feeds in penetration.
Speaker Change: It has a oxygen per fusion goggles associated with it. So it basically is with oxygen, which is a really significant part of the procedure in order to get efficacy if youre not removing the corneal epithelium and it's done at a higher radiation right. So our hope and our challenge and opportunity is to be able to.
Joseph E. Gilliam: As it relates to U.S. glaucoma, I don't think I follow that there. In fact, if you apply what I just said in terms of high-teens growth for the year and that acceleration over the course of the year into the back half, that overall, in any way you cut it, is actually an accelerating performance, which is what you'd expect with both the impact from ICD-9 as well as, obviously, IDOS coming into 2024. Okay, we can follow up offline.
Speaker Change: This product to meet the endpoint with the phase second phase III trial as you know the first phase III trial Disney.
Speaker Change: The endpoint primary endpoint from the FDA. So we're very hopeful that we're able to do this was the second trial and more importantly, we're hopeful forgetting this out to patients because of those factors that I talked about more patients for kind of want to have this procedure is going to be far more timely with their schedules.
Joseph E. Gilliam: Thank you. Thank you for that. We'll go next to Margaret Kessler at William Blair.
Operator: Hey, good afternoon, guys. Thanks for taking the questions. I wanted to maybe start on high dose again. Sorry, I'm going to be, you know, number five today on this.
Speaker Change: Going to be far better and visual rehabilitation as we move forward. So for all these reasons, what I expect and what I would want to insurers that we see a spike in usage and adoption with <unk> moving forward and so for all those reasons. We're excited moving forward and again <unk> is just the first stage we are.
Joseph E. Gilliam: But I wanted to see if there's any additional background on the initial surgery and patient cohorts for these first few high-dose cases. You know, are these patients that have been waiting for a long time in the queue? You know, are these clinicians doing multiple high-dose procedures in a day if they're already in the AAC? Anything like that would be useful. Hi Margaret. It's Joe.
Speaker Change: Already have a third generation product that's undergoing a phase III clinical trials, that's a laser that will actually use a laser over radiated light, which were more prescriptive way precisely be able to define an algorithm on the surface of the eye to be able to treat keratoconus and so if you think about it.
Joseph E. Gilliam: I mean, obviously, it's a little early with these cases having just started last week to draw any discernible trends. But I think that for a majority of these patients, I would say they're clearly stand-alone patients that, you know, these early surgeons have deemed to be straightforward in the context of bringing them into the high-dose procedure. You know, whether or not they were previously treated with different solutions and maybe even a high-dose trial, you know, et cetera, historically, there'll be a mix of that as we get going here. But I think the most important thing there is that the surgeons out of the gate are really focused on providing a stand-alone therapy of care for these patients. Okay, fair enough.
Speaker Change: Just like in <unk>, where we continue to innovate and protect share and move forward to build the marketplace. We're already has these chess pieces in place and keratoconus as well and we expect those to pay off both now and in the future.
Speaker Change: Okay I appreciate it guys.
Speaker Change: Thanks Margaret.
Speaker Change: We'll move next to Allen Gong at J P. Morgan.
Speaker Change: Yes.
Allen Gong: Hi, Jamie Thanks for the question I just had one quick one to start off just on I guess seasonality heading into next year. You ended the year with a stronger than expected quarter. Some of the headwinds that you'd feared wound up being a little better than expected and I understand that you don't want to prevent idose, but just thinking about the underlying.
Thomas William Burns: And then I wanted to maybe move over to Tefi Oksa, you know, NDA submission by the end of the year. What's the vision for the products, kind of your expectations for timing and level setting us maybe on the opportunity from a prevalence perspective to a procedure cost perspective? Yeah, Margaret, I'm happy to take that one.
Jamie: Business ex Idose should we think of it as basically being a fairly normal year from a seasonality perspective.
Jamie: Thanks Alan.
Speaker Change: It's hard to parse those between the two but I'll do my best and I think as you know in normalized conditions.
Alan: Typically see 22, 23% of our of our revenues in the first quarter, 25% in the second 24% to 25% in the third and call it 26% to 28% in the fourth.
Thomas William Burns: And so, as we said before, we'll have the results for the second phase three clinical trial by mid-year or so, and we'll be preparing an NDA. We'll hope to be able to publish those results just before we file our NDA with the FDA. We'll look for a 10-month PDUFA date or thereabouts, and we'll be approved in the late part of 2025. And when you think about it, epioxy, as we talked about before, is a highly different procedure. The fact that I don't have to remove the corneal epithelium to be able to perform the procedure is pretty extraordinary. The corneal epithelium, when it's removed, does somewhat impede visual rehabilitation.
Alan: And not surprisingly, we do expect that those patterns they pretty disrupted this year.
Alan: The combination of both the growing infinite business. So as we continue to turn on the market access side of that equation as well as most materially the idose launch over the course of 2024.
Alan: I think the net effect of that should be a fairly material shifting the seasonality. If you will to the second half and in particular, the fourth quarter. So it's not entirely that disrupted not entirely driven by idose, but that is by far the biggest driver of a shift away from our traditional seasonality patterns.
Thomas William Burns: It certainly is painful for the patient. And because of the extra time for visual rehabilitation, a lot of times it's incongruous with the young patients that are having this procedure, who would sometimes have to defer the procedures until spring break or summer until they have a little bit more time to spend at home and heal. So we have the opportunity with Epioxa of having a new formulation, which has a surfactant in it, which aids in penetration. It has oxygen perfusion goggles associated with it, so it bathes the eyes with oxygen, which is a really significant part of the procedure in order to get efficacy if you're not removing the corneal epithelium.
Alan: Yeah.
Speaker Change: Got it and then when I think about the margins for you this year.
Speaker Change: Year, how should we think about what kind of leverage you can get from Idose.
Speaker Change: The first year of launch that management might be a little limited but.
Speaker Change: My sense is that this could ultimately be quite a profitable device for you. So now that we think about the fact that you've ramped up infinite and youre going to be ramping idose, where can gross margin SG&A R&D go this year.
Speaker Change: Yes, so Alan Thanks for the question so you're right, we do expect items to be accretive in.
Speaker Change: Our gross margin over time and to your second point for now we caution you with some conservatism there could be some modest volatility in the margin as we ramp up <unk> and go through a new product launch in that.
Thomas William Burns: And it's done at a higher irradiation rate. So our hope and our challenge and opportunity is to be able to have this product meet the endpoint in the second phase three trial. As you know, the first phase three trial did meet the endpoint, the primary endpoint from the FDA, so we're very hopeful that we're able to do this with the second trial. And more importantly, we're hopeful that getting this out to patients, because of those factors that I talked about, more patients are going to want to have this procedure. It's going to be far more timely with their schedules.
Speaker Change: Associated scaling that happens from manufacturing standpoint, but that said, we expect the overall probably 2024 gross margin to land in that upper end of what we've always said was <unk> 83 to $80 range. So, we're thinking probably plus or minus 84% for the year.
Speaker Change: Okay.
Speaker Change: We'll move next to Joanne Wuensch at Citi.
Speaker Change: Okay.
Joanne Karen Wuensch: Thank you very much for taking the question.
Thomas William Burns: It's going to be far better for visual rehabilitation as we move forward. So, for all these reasons, what I expect and what I will want to ensure is that we see a spike in usage and adoption with Epioxa moving forward. And so, for all those reasons, we're excited about moving forward. And, again, Epioxa is just the first stage. We already have a third generation product that's undergoing phase two clinical trials. That's a laser that will actually use a laser of irradiated light, which will more prescriptively and precisely be able to define an algorithm on the surface of the eye to be able to treat keratoconus.
Joanne Karen Wuensch: One has to do also with the expense side of the income statement since you're investing so much in not just research and development, but also and launching multiple new products. How do we think about operating expenses for 2024.
I'll talk to my second question on at the same time, one of the things I'm trying to figure out is.
Joanne Karen Wuensch: How physicians are going to be spending their time do you think of the idose launch as maybe cannibalizing more traditional mix procedures comp.
Thomas William Burns: And so if you think about it, much like in MEGS, where we continue to innovate and protect, share, and move forward and build the marketplace, we already have these chess pieces in place in keratoconus as well, and we expect those to pay off both now and in the future. Appreciate it. Thanks, Margaret. We'll move next to Alan Gong at J.P. Morgan. Hi team.
Joanne Karen Wuensch: Complementary or how do we think about how the physician spends his or her time having them.
Joanne Karen Wuensch: Now multiple types of products to use thanks.
Joanne Karen Wuensch: You bet Hey, Joanna this is Alex I'll start with your Opex question. So I think the way to think about 2024 is to.
Alex: We expect that book to your point, both SG&A and R&D will grow.
Operator: Thanks for the question. I just had one quick one to start off just on, I guess, you know, seasonality heading into next year. You ended the year with a stronger than expected quarter. Some of the headwinds that you feared wind up being, you know, a little better than expected.
Alex: In this year as we continued to invest in our Idose launch in the pipeline.
Alex: The way I would counsel you to think about it is to start with our baseline 2023, adjusted operating expenses, which excludes the IP R&D and that number was about $360 million.
Alex: Then I would assume about 10% growth off of that base. So that would imply in 2024 Opex just shy of about 400 million for the year.
Joseph E. Gilliam: And, you know, I understand that you don't want to provide I-dose, but just thinking about the underlying business X I-dose, should we think of it as basically being a fairly normal year from a seasonality perspective? Thanks, Alan. It's hard to parse those between the two, but I'll do my best.
Alex: And then as it relates to Idose add the sort of overall, our senior dynamics within the practice framework I think the right way to answer that is to look at it both of the short and the longer term.
Alex: Certainly over the short term as we're driving training in that initial launch I don't expect it to have a significant impact to obviously the dynamics within the practice and how they they handle their time between traditional based products and the new class of procedural pharmaceuticals.
Joseph E. Gilliam: I think, as you know, in normalized conditions, you typically see 22-23% of our revenues in the first quarter, 25% in the second, 24-25% in the third, and call it 26-28% in the fourth. And not surprisingly, we do expect those patterns to be pretty disruptive this year. By the combination of both a growing, you know, infinite business, as we continue to turn on the market access side of that equation, as well as, most materially, the EIDOS launch over the course of 2024, I think the net effect of that should be a fairly material shifting of the seasonality, if you will, to the second half and, in particular, the fourth quarter. So it's not entirely the disruption is not entirely driven by EIDOS, but that is by far the biggest driver of a shift away from our traditional seasonality pattern.
Alex: As we move forward you can expect that with success I think idose likely will cannibalize to a certain extent some of those traditional mixed procedures as surgeons get more and more confident and utilizing the product in the reimbursement associated with et cetera, and utilize it whether it's a standalone product or in combination with.
Alex: Cataract surgery or in combination with other procedures as Tom mentioned earlier, depending upon the needs of the individual patient.
Alex: But over the long term.
Alex: Our expectation is that <unk> really becomes a cornerstone of.
Joseph E. Gilliam: Got it. And then when I think about the margins for you this year, how should we think about what kind of leverage you can get from Eidos? You know, it's the first year of launch, but I imagine it might be a little limited. But my sense is that this could ultimately be quite a profitable device for you. So now that we think about the fact that you've ramped up Infinite and you're going to be ramping up iDose, where can gross margin, SG&A, and R&D go this year? Yeah, so, Alan, thanks for the question. So you're right, we do expect IDOS to be accretive to our gross margin over time. And to your second point, you know, for now, we'd caution you with some conservatism, as there could be some modest volatility in the margin as we ramp up IDOS and go through a new product launch and the associated scaling that happens from a manufacturing standpoint. But that said, you know, we expect the overall 2024 gross margin to land in that upper end of what we've always said was an 83 to 84 range. So we're thinking probably plus or minus 84% for the year.
Alex: The interventional glaucoma paradigm that we've talked about in the past and we would expect more and more practices both through the investment of <unk>.
Alex: <unk>, new surgeons as well as shifting of their own allocation of time for them to be spending more and more time treating.
Alex: Glaucoma patients with minimally invasive solutions, just like Idose and others and we put forward and we are putting forward a significant amount of investment to drive that change.
Alex: In the standard of care over the course of many years as we move forward here.
Speaker Change: Thank you.
Speaker Change: Our next question comes from David Saxon at Needham <unk> Company.
Speaker Change: Yes.
David Saxon: Great. Good afternoon, thanks for taking my questions.
David Saxon: Maybe I'll start on the U S. Glaucoma sales force are you doing anything.
David Saxon: And compensation or incentive to ensure there is a focus on the idose launch, but to also make sure they are not forgetting.
David Saxon: Like inject infinite et cetera, so the rest of the U S business doesn't kind of stall out.
David Saxon: Yeah.
Speaker Change: Yes, David.
David Saxon: Well the short answer is yes.
Speaker Change: And clearly.
David Saxon: We've got a pretty well structured.
Operator: We'll move next to Joanne Wuensch at Citi. Thank you very much for taking the question. Two, one has to do also with the expense side of the income statement.
David Saxon: Strategy as it comes to compensation, both as it relates to new product launches as well as existing business, we're deploying that here it's absolutely.
Alex Thurm: Since you're investing so much in not just research and development but also in launching multiple new products, how do we think about operating expenses for 2024? And I'll post my second question at the same time. One of the things I'm trying to figure out is how physicians are going to be spending their time. Do you think of the IDOS launch as maybe cannibalizing more traditional MIGS procedures? Complementary, or how do we think about how the physician spends his or her time now having multiple types of products? You bet. Hey Joanne, this is Alex.
Not a science when it comes to doing that but we think we've got the right balance of continuing to drive really three things first as you referenced the idose launch activities around that second the other areas of the business in terms of revenue generation, whether it be istent inject or certainly istent infinite.
David Saxon: As we continue to drive that forward and third really incentivizing the kind of behaviors to support what I just answered in the last call, which is putting in place those foundational building blocks and driving the activities that we think will expand the market over the next several years and certainly the next decade as we think about what's going to really matter to driving this business not just in 2024.
Alex Thurm: I'll start with your OpEx question. So I think the way to think about 2024 is, you know, to expect that both, to your point, both SG&A and R&D will grow this year as we continue to invest in our ITOS launch and the pipeline. The way I would counsel you to think about it is to start with our baseline 2023 adjusted operating expenses, which excludes IPR&D, and that number was about $360 million. And then I would assume about a 10% growth off of that base.
David Saxon: But far beyond.
Speaker Change: Great. That's helpful. And then just on the pipeline looking at Lucian.
Speaker Change: So phase two a start in the fourth quarter what are the milestones this year.
For that pipeline product and what's a reasonable expectation for when that could be commercial thanks. So much.
Speaker Change: Yes, David I'll be answering the first part of your question, we're going to be looking at.
Speaker Change: Assessing completing necessity that clinical trial for IV <unk> Travoprost this year, and we expect to be able to have data in hand by the end of this year and when we see that data. We will then make determinations on how we go forward into a phase potential phase III. So I can't answer the second part of your <unk>.
Alex Thurm: So that would apply 2024 OPEX, just shy of about $400 million. And then as it relates to, you know, IDOS and the sort of overall procedure dynamics within the practice framework, I think the right way to answer that is to look at it both over the short and the longer term. You know, certainly over the short term, as we're driving training and that initial launch, I don't expect it to have a significant impact to obviously the dynamics within the practice and how they handle their time between traditional MIGS products and the new class, the procedural pharmaceuticals. Certainly, as we move forward, you can expect that with success, I think IDOS likely will cannibalize to a certain extent some of those traditional MIGS procedures as surgeons get more and more confident in utilizing the product and the reimbursement associated with it, etc., and utilize it, whether it's a standalone product or in combination with cataract surgery or in combination with other procedures, as Tom, you know, mentioned earlier, depending upon the needs of the individual patient.
Speaker Change: But I can tell you that we're excited about our dilution both with traveling <unk> seen the data as well.
Speaker Change: Evolution in the use of dry eye, where we saw substantial changes in visual acuity as well as substantial improvements in terraform stability. So these are two leading candidates and Apis for this new platform that we hope will be a significant contributor for us in the future.
Speaker Change: Great. Thanks, so much.
Speaker Change: We'll move next to Anthony Petrone at Mizuho group.
Anthony Charles Petrone: And Anthony Your line is open you may ask yourself muted.
Anthony Charles Petrone: Hearing no response, we'll move next to Sam Brodowski at Trust Securities.
Sam Brodowski: Hey can you hear me okay.
Sam Brodowski: Yes, it came against that debt.
Alex Thurm: But over the long term, you know, our expectation is that IDOS really becomes the cornerstone of the interventional glaucoma paradigm that we've talked about in the past. And we would expect more and more practices, both through the investment of new surgeons, as well as a shift in their own allocation of time, for them to be spending more and more time treating glaucoma patients with minimally invasive solutions, just like IDOS and others.
Sam Brodowski: Great. Thanks for thanks for taking my question I was just.
Sam Brodowski: Squeeze two quick ones then on Idose.
Sam Brodowski: You had mentioned second half assumption for the J code floating permanent nail.
Now you're down on whether the guidance assumes July one or October one and then on the ASP.
Speaker Change: And any incremental color on what the realized ASP is going to be and how much. We can extract in terms of gross to net discount there.
Joseph E. Gilliam: And we put forward, and we are putting forward a significant amount of investment to drive that change in the standard of care over the course of many years as we move forward here. Thank you. Our next question comes from David Saxon at Needleman. Good afternoon.
Speaker Change: Yes, sure Sam It's Joe I think maybe to put a little bit more color just in terms of technical dates that were behind what Tom suggested by putting in that application. Prior to the end of the year you would assume that the CMS cycle will deliberate J code starting July one.
Operator: Thanks for taking my questions. Maybe I'll start on the U.S. glaucoma sales force. Are you doing anything to provide compensation or incentives to ensure there's a focus on the PITOS launch but to also make sure they're not forgetting, like, inject, infinite, et cetera, so the rest of the U.S. business doesn't kind of stall out? Yeah, David.
Speaker Change: That also translates into reported asps by the by the fourth quarter, both of which each of those are incremental drivers in terms of creating a seamless I'll call it market access or reimbursement environment around that J code in.
Speaker Change: Overall idose.
Speaker Change: As you think about.
Speaker Change: <unk>.
Speaker Change: The really the.
Speaker Change: Yes.
Joseph E. Gilliam: Well, the short answer is yes. And clearly, we've got a pretty well-structured strategy as it comes to compensation, both as it relates to new product launches as well as existing business. We're deploying that here. It's absolutely an art, not a science when it comes to doing that, but we think we've got the right balance of continuing to drive really three things.
Speaker Change: Broader dynamic around the Idose launch those things are going to be real key drivers as we've talked about alongside the training initiatives and the things that are there too.
Speaker Change: To unlock if you will the items opportunities we move forward.
Speaker Change: And I know you had a second question as well.
Speaker Change: Gross to net so as we've talked about we will not be doing rebating associated with the idose product.
Joseph E. Gilliam: First, as you referenced, the Eidos launch and activities around that. Second, the other areas of the business in terms of revenue generation, whether that be, you know, I spent in Jack, or certainly I spent an infinite amount as we continue to drive that forward. And third, really incentivizing the kind of behaviors to support what I just answered in the last call, which is putting in place those foundational building blocks and driving the activities that we think will expand the market over the next several years. And certainly the next decades, we think about what's going to really matter to driving this business, not just in 2024, but far beyond. Great, that's helpful. And then just on the pipeline, looking at iLution, phase 2a, starting the fourth quarter, what are the milestones this year for that pipeline product, and what's a reasonable expectation for when that could be commercial? Thanks so much.
Speaker Change: But where you will see that as obviously in government related programs, where there's standard discounts and so over time a portion of our revenues we realize that.
Speaker Change: That 23% discount that's typical with government related programs.
I think it's probably fair to say in this.
Speaker Change: We will keep you apprised as we move forward that our realized ASP somewhere in the $13000 range is probably a safe place to start from a modeling perspective, and we'll dial that it over time as our mix becomes more clear.
Speaker Change: Okay.
Speaker Change: Great. Thanks for taking my questions.
Speaker Change: And at this time that does conclude the question and answer session I would now like to turn the conference back over to management for closing remarks.
Speaker Change: Okay I want to thank you all for your time and attention today and we also thank you for your continued interest and support of caucus Goodbye.
Thomas William Burns: Yeah, David, I'll be able to answer the first part of your question. We're going to be looking at assessing, completing, and assessing that clinical trial for the iLucian Trabel process this year. And we expect to be able to have data in hand by the end of this year. And when we see that data, we'll then make determinations on how we go forward into phase, potential phase three. So I can't answer the second part of your question, but I can tell you that we're excited about iLucian, both with the travel process. And then you've seen the data as well of iLucian in the use of dry eye, where we saw substantial changes in visual acuity as well as substantial improvements in tear film stability.
Speaker Change: This concludes today's conference call. Thank you for your participation you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Thomas William Burns: So these are two leading candidates and APIs for this new platform that we hope will be a significant contributor for us in the future. Great, thanks so much. We'll move next to Anthony Petrone at Mizuho Group. And Anthony, your line is open. You may have yourself muted.
Speaker Change: Yes.
Operator: Hearing no response, we'll move next to Sam Berdosky at Truist Security. Hey, can you hear me okay? Yes, we can. We can. Great, thanks for taking the questions. Squeeze two quick ones in on I-Dose.
Speaker Change: Yes.
Speaker Change: Okay.
Joseph E. Gilliam: I think you mentioned the second half assumption for the J-code for the permanent. Can I nail you down on whether the guidance assumes July 1 or October 1? And then on the ASP. Any increments of color on what the realized ASP is going to be and how much we can expect in terms of growth in that or... Yeah, sure, Sam. It's Joe.
Speaker Change: Okay.
Speaker Change: Yes.
Joseph E. Gilliam: I think maybe to put a little bit more color in terms of the technical dates that we're behind what Tom suggested. By putting in that application, you know, prior to the end of the year, you would assume that the CMS cycle would deliver a J-code starting July 1. That also then translates into reported ASPs by the fourth quarter, both of which are incremental drivers in terms of creating a seamless, you know, I'll call it market access or reimbursement environment around that J-code and overall IDO. As you think about, you know, really the, you know, broader dynamic around the IDOS launch, those things are going to be real key drivers, as we've talked about, alongside the training initiatives and the things that are there to unlock, if you will, the IDOS opportunities as we move forward.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: [music].
Joseph E. Gilliam: And I know you had a second question as well. Yeah, so as we've talked about, we will not be doing, you know, rebates associated with the iDOS product, but where you will see that is obviously in government-related programs where there are standard discounts, and so, you know, over time, a portion of our revenues we realize that, you know, that 23% discount that's typical for government-related programs. So I think it's probably fair to say, and this will keep you informed as we move forward, that a realized ASP somewhere in the $13,000 range is probably a safe place to start from a modeling perspective, and we'll dial that in over time as our mix becomes more clear.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Operator: And at this time, that does conclude the question and answer session. I would like to turn the conference back over to management for closing remarks. Okay, I want to thank you all for your time and attention today, and we also thank you for your continued interest and support of Glaukos. Goodbye. This concludes today's conference call. Thank you for your participation. You may now disconnect.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: Okay.