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spk00: Welcome to Glowcoast Corporation's first quarter 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.glowcoast.com. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star, then the number one on your telephone keypad. To withdraw your question, please press start one again. This call is being recorded and an archived replay will be available online in the investor relations section at www.glowcoast.com. I'll now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.
spk02: Thank you and good afternoon. Joining me today are Glowcoast Chairman and CEO Tom Burns, President and COO Joe Gilliam, and CFO Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the financials and filings quarterly results section titled quarterly summary. This document is designed to provide the investment community with a summarized and easily accessible reference document that details the key effects 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. Please note that all statements other than statements of historical facts made on this call that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements. These include statements about our plans, objectives, strategies, and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, efficacy of our current and future products, competitive market position, our regulatory strategies and reimbursement for our products, financial condition, and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment. all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements. Review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the investor section of our website at www.cloudcoast.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis, We believe these financial measures can facilitate a more complete analysis and greater transparency into CloudCoast's ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables and our earnings press release available on the Investors 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 CloudCoast's Chairman and CEO, Tom Burns.
spk08: Okay, thanks, Chris. Good afternoon, and thank you all for joining us. Today, Glockos reported first quarter net sales of approximately 74 million, up 9% versus the year-ago quarter on a reported basis, and up 11% on a constant currency basis. Our first quarter results in return to top-line growth reflects continued strong performance across our international glaucoma and corneal health franchises, alongside the re-emerging growth in our U.S. glaucoma franchise, driven by the initial commercial launch of iSpend Infinite. I'd like to recognize the continued dedication and performance of our teams around the globe who remain committed to their work in advancing our key initiatives. Given our solid first quarter and latest forward outlook, we are raising our 2023 net sales guidance range to $295 million to $300 million, versus 290 to 295 million previously. From a commercial perspective, strong execution of key strategies within our core franchises drove an encouraging start to the year. Within our U.S. glaucoma franchise, where we delivered 4% year-over-year growth in the quarter, we are progressing our combo cataract efforts and continue to advance ICE and Infinite ahead of establishing formal MAC coverage and payment. In parallel, we are accelerating our founding mission at Glaucus, which is to advance glaucoma care by driving intervention of therapies earlier in the treatment paradigm for glaucoma disease, and in turn, pioneering a new standalone market over time. These efforts will be on full display at the ASCRS meeting this weekend in San Diego, where an extensive array of symposia highlighting the performance of our novel technologies will be presented. This includes a new subgroup analysis of the combined IDOS phase 3 trials, which demonstrated statistically significant superiority of IDOS's IOP lowering effect versus current standard of care topical prostaglandin therapy. We believe this first-of-a-kind, real-world effectiveness data further validates the game-changing potential of IDOS. Moving on. Our international glaucoma franchise delivered strong broad-based growth this quarter of 20% on a reported basis and 28% on a constant currency basis. And our corneal health franchise saw 10% growth as key strategic initiatives continue to take hold in support of this important business. In addition to our commercial efforts, we also continue to prudently invest in and 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. During the first quarter, we achieved a significant company milestone with the successful NDA submission of iDoseTR, our novel microinvasive interocular implant designed to continuously deliver therapeutic levels of proprietary formulation of travel cross from within the eye for extended periods of time. We're also pleased to announce today we recently received communication from the FDA that our submission has been received and accepted for substantive review. We look forward to learning of our PDUFA date imminently, which we expect will be in line with our approval target by year end. Alongside this, our teams continue to make encouraging progress with the preparation and planning of the IDOS commercial launch targeted for early next year. Turning to the corneal health pipeline, we've built strong subject enrollment momentum in the second phase three confirmatory trial for Apioxa, our next generation corneal cross-linking therapy for the treatment of keratoconus. And we are now on track for targeted enrollment completion by mid-year, ahead of our prior expectations of year end. 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, given the macroeconomic environment and associated uncertainties, as well as anticipated investment to support the potential commercial launch of IDOS, we continue to prudently review the prioritization and cadence of our investments as we strive to strike the right balance of risk-based investments in our capital position now and in the future. As such, we will continue to keep you updated as we evaluate and potentially adjust development timelines associated with our earlier stage pipelines. In conclusion, I'm very pleased with the strong start to the year and excited about what is to come as we continue to advance our mission to truly transform vision with disruptive, dropless, and game-changing technologies. And so with that, I'll open the call to questions. Operator.
spk00: Thank you. As a reminder, if you would like to ask a question, please press star then 1 on your telephone keypad. The first question is from Tom Stephan with Stiefel. Your line is open.
spk06: Great. Hey guys, thanks for the questions and congrats on the strong quarter and also the IDOS NDA acceptance. And I think I'll start there actually, kind of big picture with IDOS. I want to ask about just the technology and candidly, not totally familiar with the patents, the IP, et cetera, but with what you're willing to share, you know, what type of optionality does the technology itself have? Maybe this can be in the form of drug optionality or even possibly licensing the technology. And I guess where I'm, going with this is maybe even beyond IDOS TR, T-Rex, ROC, how should we be thinking about the value of the broader IDOS platform beyond just the products themselves in the pipeline?
spk08: Yeah, Tom, I'll be happy to take that question. So this is something I've addressed previously, but happy to be able to talk about it again. I think IDOS is an incredible platform. And so you've seen what we've been able to do with the Prostaglandin analog travel cross, being able to obtain 70% control of patients on the same or fewer meds at three years in glaucoma. I think you're also aware that we're pursuing a Rokinus inhibitor, which can be encapsulated in the vessel of the iDose platform, which we think could be an extraordinary combinatorial treatment for glaucoma in the future. The technology itself is pretty robust. It allows us to be able to consider a number of active pharmaceutical agents that we can be able to treat anterior segment disease. I think we need to focus, and we will focus, on small molecules. That's where the limitations of the platform rest. But there are a host of small molecules that you could consider as we look to develop forward. These small molecules have to be invariably potent. They have to have high nanomolar concentrations, and they have to be relatively insoluble. Having said that, you know that we must be looking at a number of different agents that can be able to exploit the opportunity of the platform that we've created and then carry us forward into the next decade. The patents on the technology itself are profound and take us into the next decade. both from a method and apparatus standpoint. And then I think you know as well, we look for taking the current product of iDose and being able, just with a simple modification to the platform itself, being able to create an extended release version that we're calling iDose T-Rex that will hold nearly twice the amount of travel cross medication as the first generation iDose version. And we believe that will give us another kind of a material event to be able to launch a second generation product in the 2020s. So this is where we're focused as a business. As I've talked about in general, we have a number of platforms. iDose is an exceedingly powerful platform that can serve this company both now and in the future with multiple variations.
spk06: Super helpful. Thank you, Tom. My second question is just on the guidance. Great to see you guys raise it. I guess just the components of it. How should we be thinking about what's changing? I think U.S. glaucoma is thought to be flat, but that was really strong in the quarter. I think OUS glaucoma, low double digits, and corneal health, high single digits previously. You know, Joe or Alex, maybe what's changing? And then as a follow-up to U.S. glaucoma, just on ice then, any updated view you know, your potential, I guess, level of confidence that we've hit a true point of stability with that in the U.S. And, you know, maybe we are past the worst of reimbursement headlines. So two-parter there, but thanks for the questions.
spk11: Sure. Hey, Tom, it's Joe. I'll start with that. And if Alex wants to jump in, he can. You know, obviously it was, if you dig in more, you know, tonight, it was definitely a high-quality first quarter. solid execution and we were pleased to be able to raise the guidance by 5 million, as you noted. If you think about that in the context of the individual franchise, the way you asked the question, I'm not so sure, despite the strength in the first quarter across the board, that there's a significant material change to how we thought about the original guidance on a franchise-by-franchise perspective, although obviously we're slightly incrementally positive across the board and probably in U.S. glaucoma in particular. But, you know, we still want to be somewhat cautious as we make our way, you know, through 2023 and particularly until we get, you know, more certainty around the math timelines associated with iStent Infinite and what that can mean in terms of accelerating the growth of the U.S. franchise and our business overall in 2023. If you talked about, you know, one subcomponent of that, obviously as the combo cataract makes business here in the U.S. and you characterize it obviously as iStent, I think we were encouraged to see continued stability in the quarter in that franchise as well as actually a restoration of growth in our combo cataract business for the first quarter. And as you know, coming out of the last year where the CMS-related headwinds were having an impact, It was a very encouraging sign to see that return to a growth cadence as we started the year.
spk04: Very helpful. Thank you.
spk00: The next question is from Margaret Coxor with William Blair. Your line is open.
spk14: Hey, guys. This is actually Mike on for Margaret. Congrats on the nice quarter, and thanks for taking the questions. So I just wanted to maybe start out on the quarter, follow up a little bit on your comments on U.S. glaucoma. Was there any new products that you'd call out having tracked better than you expected this year, like maybe iPrime or even iAccess, or was it mostly the core iStank returning to growth, like you guys mentioned?
spk11: Yeah, thanks for the question, Mike. I think It was broad-based in the context of the stabilization and the growth we were able to demonstrate. I'd probably characterize it as sort of a little bit of a recap of what I just said. The starting point was stabilization and some modest growth coming out of the combo cataract franchise, which now we ultimately have multiple potential tools working within that. And then on top of that, we started to see that impact of iStent Infinite in particular. And I think we were, if I was going to call one thing out, I would call out Einstein Infinite in particular as really being a nice driver of the performance in the first quarter and the outperformance versus our expectations for sure.
spk14: Got it. That's helpful. And then maybe one longer term just on the standalone opportunity, you know, with Einstein Infinite picking up and then IDOS becoming part of the picture next year. You guys have mentioned making an effort to maybe raise awareness for standalone intervention in the market. Can you maybe speak to any market building initiatives you started to look at or may pursue in the future?
spk11: Yeah, I'd be happy to, Mike. And, you know, and then I'll let Tom jump on as well, because quite frankly, this has been something that's been a part of, you know, the founding mission here, which Tom's been a part from the beginning. So I think it's good for him to comment. But as we sit here today, we're putting a lot of effort and investment into really changing that mentality and that treatment paradigm. And you've heard us talk for years about the fact that topical medications work. The challenge with topical medications is the compliance rates and some of the side effects and various things that come alongside it. And for us, now that we have available a suite of tools that are truly minimally invasive and able to intervene, and I think in an attractive way from a risk-benefit standpoint. Now is really the time for us to be putting that behind it. It's an organic initiative more than a traditional marketing program, right? This is about the leaders of the industry out there, the key opinion leaders, all the various folks who've been saying this for some time, and us trying to really help drive the energy and enthusiasm behind that to the next level, particularly as you think about it in the context of, for us, Iced and Infinite and then IDOS going forward as two important tools to help support that from a product standpoint. Tom?
spk08: Yeah, I think what I would say, Mike, is that the whole concept of interventional glaucoma really was the birthright for how this company got founded. And we saw just a tremendous opportunity to take a single injection of either an iStent or, as we've evolved, an iDose that could be able to liberate patients from a consignment to drug therapy over the course of their lives. And so iDose and MIGS, I think, entirely changed the benefit to risk calculus of what topical drops have been able to do for patients. And we know that patients that are on topical drop therapy progress. despite the fact that they're diagnosed and followed. And I think the advent of iDose and iStent Infinite now changes a whole new paradigm and forces surgeons to be able to confront the current algorithm of how they treat patients. And we'll be driving that. Much like we created the entire market of MIGs, we will be creating this market of interventional glaucoma led by the catalysts of iDose and iStent Infinite. I think the question always comes up, where will they be seated and where will they take place? When we do launch iDose, and certainly it's happening with iStand Infinite as we speak, we know that surgeons will look to pseudothakic patients first while they get their sea legs on a standalone basis. And then there's a whole array of patients that are noncompliant that surgeons and clinicians can serve. You've seen some of the recent data showing that the rate of noncompliance can be as high as 90%, which really encapsulates most of open-ended glaucoma patients. We think there's tremendous promise to serve patients that are intolerant to medications, those patients who have high degrees of hyperemia, allergy, periorbital fat atrophy, et cetera. And I think there'll also be a tremendous reason to reduce drug burden. You know, over half of patients who are diagnosed in glaucoma around two or more medications, which further exacerbates noncompliance. And we can reduce drug burden by placing them on a foundational therapy like iDose. It can make a considerable difference. Let's not forget as well that there's a huge patient convenience and quality of life factor. Topical drops are difficult, and they are a nuisance and a burden on the quality of life for patients. And so we do believe that another of these surgeons will look to these standalone opportunities to be able to liberate the patients from topical drops. And finally, make no mistake that we think that surgeons and clinicians will look at, currently where they're focused now, anytime you have a combined procedure like a cataract procedure and you have the ability to treat comorbid glaucoma, we see and believe that there'll be a strong appetite for the interventional technologies such as Infinite and iDose.
spk04: Very helpful. Thanks a lot, guys. Thanks.
spk00: The next question is from Ryan Zimmerman with BTIG. Your line is open.
spk01: Hey, guys. Thanks for taking the questions. And again, tip of the hat to Chris Lewis on the most efficient earnings call that we have here. So I just want to highlight a couple – or just ask a couple things, Tom. So you guys highlighted the study today on the use of PGAs versus IDOs. You know, you submitted with the data package, I recall, the repeat usage study. And so, you know, I'd love to just get your thoughts on kind of how you're viewing the data in the context of some of the other studies. And, you know, each has their merits and their own rights. But ultimately, I think what investors care about is and what they want to know is what do you think the label ultimately looks like given the studies you've run and what do those studies do to kind of set the stage for utilization of Eidos when it does come?
spk08: Okay, Rob, well, let me hit that head on. I mean, the label that we're seeking is a wide-open label, and that label is based on a 505B2 designation that basically is based on the predicate of topical prostaglandin therapy, like a travel front. So the label that we're seeking is one that will basically say for the reduction of interocular pressure in patients with hypertension and open-angle glaucoma. So that label will allow us to approach the full array of glaucoma patients and pre-glaucoma patients who have ocular hypertension. So there's no restrictions. The label has never been based upon trying to find out what the duration of effect is. The duration of effect will be served by our Phase IIb studies, which show, again, at three years that we're controlling the vast majority of patients on the same or fewer topical medications. And that's how we'll go to payers. And so that's kind of the seminal interest there. When I look at the data that you just talked about, I get extremely excited about what the possibilities can be. This is a subgroup analysis of patients that were on pretreatment topical prostaglandins. They were washed out of the medication. Their pressures went up to roughly 24 millimeters. And after the implantation of I-DOS, their pressures actually increased. were driven lower than they were pre-treatment. As a matter of fact, here, on the order of greater than a millimeter, which by any indication that any surgeon will tell you, will lead to a 10% to 13% decrease in the propensity for blood comatose progression. So this is a highly statistically significant finding, and I think one that will help us not only talk about the long-term view of IDOS, but actually the more shorter-term view real-world efficacy versus the topic of prostaglandin therapy.
spk01: Okay. That's very helpful, Tom, and, you know, certainly looking forward to it. On the application itself, you know, congrats on getting it accepted. I just want to be clear, no PDUFA date yet. Are you waiting on a day 74 letter? I just want to be clear when you expect that PDUFA and make sure there's nothing, you know, to read into there, given that you don't have that in hand yet.
spk08: No, it's a good question. We have high confidence that we'll be receiving the day 74 letter literally in the matter of a few days. And so our expectation is to be issued a PDUFA date at that time, which will then put us in place to achieve our target of FDA approval of IDOS by the end of the year.
spk04: Okay. Good stuff, guys. Thank you. Welcome. Thanks, Frank.
spk00: The next question is from George Sellers with Stevens. Your line is open.
spk05: Hey, thanks for taking the question. I just have one on the international side of the house. Could you just give us some color on how some of the international welcome markets trended throughout the quarter? And then also, have you seen any increased pressure from a competitive standpoint internationally? Thank you.
spk11: Hi, George. It's Joe. I'll cover that. From an international headline standpoint, it was a standout quarter, right? We had record sales of a little north of 21 million and just strong performance across the board, across the various regions. I can't point to any particular event that generated the outsized performance in the quarter. It was broad-based across America's across Europe, Asia, and really on a global basis. I think that we continue to do very well in virtually all of the markets versus competitive forces. In particular, we see that a bit more pronounced in Europe, as you might expect. And I think our team continues to do a great job of holding the line and continue to grow that business quite impressively in the face of a lot of effort from competition. I think it speaks a lot to the amount of data that we've generated over the course of the last decade plus around the optimization of the risk-benefit calculus associated with the iSTED franchise. So we couldn't be more pleased with the continued performance outside the U.S.
spk04: Okay, great. I'll just leave it at one. Congrats on a great quarter. Thanks, George.
spk00: The next question is from Matthew O'Brien with Piper Sandler. Your line is open.
spk04: Hey, this is Phil on for Matt.
spk15: Thanks for taking our question. Just some clarification on the iDose NDA process here, and apologies if this is a bit rudimentary, but by my math, you received approval at the end of last week, and because you still expect to you know, the PDUFA date by year end, do you expect to receive accelerated as opposed to standard review here? And, you know, when exactly does that six or ten month clock begin?
spk08: Well, Phil, as you probably recall, we filed, I believe it was on February 27th. And so, we'd be looking at a PDUFA date that would be ranging from there, actually, forgive me, February 10th. And so we've been looking from that as the starting course from the date of when we file to when we expect to receive the PDUFA date. And so to your question, the date 74 review should identify that PDUFA date and then give us a mid-cycle review that will be entertaining with the FDA any questions to move the NDA submission along. And again, we remain confident that we'll be in a position to be able to achieve a potential review approval by the end of the year.
spk15: Okay, that's helpful. Thank you. And then just one on guidance. I mean, you beat by about $6 million in the quarter, raised by about $5 million. Is there any reason why your current expectations are, you know, about the same now than at the start of the year? And specifically as it pertains to staffing, you know, we're hearing about this backlog and, you know, as it pertains to staffing, any line of sight until when that might be getting better? Sure, Phil.
spk11: I think, well, first, just a, you know, macro point around passing through the $6 million of outperformance. I think five versus six is kind of a rounding error in the grand scheme of things. And you'll recall we didn't really give Q1 guidance. We gave annual guidance. So, I think that that's generally a narrative that probably needs to have an error bar established around it before you draw any conclusions on it. More broadly speaking, I'd say obviously it's still early. It's only been two months since we established, you know, the initial 2023 guidance, like all companies reporting in the first quarter. And we were pretty clear that we wanted to walk before we run as it relates to setting expectations for this year. And I believe our guidance raised today is a strong step in the right direction. If you think about it, 2023 for us is all about establishing the strongest foundation possible ahead of what we hope is a transformational period for us with infinite eye dose and then ultimately epioxin. So Q1 was a good start in that direction, but it's still early.
spk04: Thanks for taking our questions.
spk00: The next question is from Alan Gong with J.P. Morgan. Your line is open.
spk13: Hi, team. Congrats on the good quarter. I'll also leave it at one since I think a lot of the, you know, most pertinent questions have already been asked. But just, you know, thinking about the Corneal Health business and specifically, you know, EpiOff and Epion, you know, my understanding was that the orphan drug designation for EpiOff would be expiring this year. So I'm just curious if you had any visibility into any, you know, potential competitors maybe looking to start their own trials. or if that's something that we still have to wait a little bit longer before we see anything on that front. Thank you.
spk09: Yeah, I'd be happy to take this, Alan.
spk08: So the orphan drug designation has terminated, as we talked about in previous calls. And what that does is allow a competitor to begin to file for approval. But to answer your question directly, we're aware of no competitor that has entered into a Folsom Phase III clinical trial. that would be competitive to us. And so therefore, we wouldn't expect to see any alternative version of any corneal cross-linking procedure for several years.
spk00: The next question is from David Saxon with Needham. Your line is open.
spk12: Hi, guys. This is Joseph on for David. Thanks for taking our questions. Maybe continuing with Corneal Health, do you think maybe we're at a point now where reimbursement is no longer an issue for docs? Or would you say maybe there's more wood to chop there for the market access team? And then, if possible, could you maybe give us your thoughts around penetration there? Maybe what kind of traction are you seeing outside of the group of doctors, the high volume group of doctors? Thanks.
spk11: Yeah, I'm happy to talk about that in the context of the overall Cornell Health franchise. I think in general, reimbursement will always be in focus for surgeons and their practices. It's highly relevant. They're always going to be watching and monitoring what's going on there. I will say that one of the more significant investments that we made over the course of certainly the second half of 2022 was in the payer side of our market access organization. And I think that certainly made a difference for us in terms of our speed to address issues as they emerged with commercial payers. and our ability to stay out in front of those as best you can in a world that inevitably always has some volatility. I really, we're pleased with the investments we've made there and how that has, I'll say, thus far quieted some of the volatility that we had seen historically and then how that translates, of course, into, you know, I'll call it reimbursement confidence for some of the surgeons that deliver the Photrexotherapy, as you asked. I think more broadly, you asked about penetration, and I would say that, you know, as we continue to drive investment in this business, a big portion of that from a macro standpoint is towards raising awareness and the diagnosis of the disease. I think there are a lot of practices out there who perform Photrexa and cross-linking Today, we've done a great job, I think, of getting the technology and the solutions deployed out into the market. One of our bigger challenges over time is to continue to drive that awareness of the disease to make sure that these patients aren't getting lost to alternative therapies that put at risk their cornea, quite frankly. So we've been doing quite a bit around initial, I'll call it creative DTC campaigns and the various things you can imagine, as well as helping the ecosystem to drive initial diagnosis and then referrals to those centers who offer the Photrexotherapy.
spk12: Okay, yeah, great. That makes a lot of sense. And maybe building off that a little bit more, just given all the investments you guys have been talking about, I was wondering if you could maybe give us some cadence around OPEX spend for the year, I guess like quarterly cadence. Hey, Joseph, this is Alex.
spk03: I'm happy to answer that one. So I think the way to think about it is there's a couple things. First of all, you know, I'll mention that we printed $88 million in the quarter for OpEx, but there were some, I'll call them non-recurring, one-time items within that number of about $5 million. Some of it related to the IDOS Biduza fee. Some of it related to some stock compensation. So if you think about Backing out that, you get to about an $83 million on a more normalized basis. So starting with that base, the way to think about kind of the cadence for the rest of the years, if you take that and assume some modest increases over the course of the year, then you're going to kind of arrive at the end of the day near what we talked about in the last call, which is around a 10% growth rate over our last year's normalized OPEX levels.
spk12: Okay, great. That's super helpful. Well, appreciate it, you guys. Thanks for taking our questions, and congrats on a great quarter. Thank you.
spk00: The next question is from Anthony Patron with Mizuho Group. Your line is open.
spk10: Thanks, and congrats on a strong 1Q result here. One on just the base business, one on IDOS. Just on the base, obviously this quarter we're hearing a lot about procedure rebounds. And we're seeing that in ophthalmology as well, although a little bit nuanced with J&J earlier in the quarter. And so when we look at the core iSTEM business, just trying to get an idea of where procedures are at this point and if there's any backlog recapture that you're seeing. And then the quick follow-up on iDOS would be just a clarification on the PDUFA date. You know, is there a panel, advisory panel meeting that You're expecting just updated thoughts on that process. Thanks again and congrats.
spk11: Yeah, I'll start and then I'll hand it over to Tom for the second part of your question. I think the overall markets both in the U.S. and the majority of the markets internationally are pretty healthy at this point in the context of the combo cataract, the volumes, and I think to your point, You've heard that somewhat consistently from others, and I think you'll continue to hear that. There still are the dynamics around staffing, and I'm sure that leads to some backlogs depending upon the practice you're talking to, and that'll continue to work itself out. It's hard to point to that as an individual line item contributor to any one period of time, any month or quarter. I think the reality is that these guys have been operating consistently on the margin with a little less than optimal staffing for some period of time now. I hope that continues to lead to a bit of tailwind. But at this point, all I can say is we definitely do continue to see expansion of the market in both the core combo cataract market. But then if you think about it, probably even more importantly, the beginning of the opening of that broader standalone opportunity with iStat Infinite as we lead our way towards Eidos. I think that as we talked about over the years, that broader opportunity from a growth perspective should dwarf the combo cataract market that we're talking about today.
spk08: Tom? Okay, and Anthony, I need to make one correction. The NDA we submitted was on February 22nd. I think I mentioned I thought it was on the 10th. And so February 22nd, and we filed for substantive review on April 23rd. Our expectation for the PDUFA data will be on May 5th with the day 74 letter. And so we, given that rationale, we expect to receive the PDUFA date again by the end of the year.
spk09: And we do not expect to have to engage with an advisory panel.
spk04: Thank you so much.
spk00: We have no further questions at this time. We'll turn it over to Tom Burns for any closing remarks.
spk08: Okay, I want to thank you all for your time and attention today, and thank you again for your continued interest and support in Globcos. Goodbye.
spk00: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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