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spk06: Welcome to Glass Coast Corporation's second quarter 2022 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.glasscoast.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 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 again. This call is being recorded, and an archived replay will be available online in the Investor Relations section at www.Glockhost.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs. Please go ahead.
spk02: Thank you, and good afternoon. Joining me today are Glockhost Chairman and CEO Tom Burns, President and COO, Joe Gilliam, and CFO, Alex Thurman. Similar to last quarter, 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 has been and will continue to be provided alongside the company's earnings press release, and it's 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 quickly transition into the question and answer session. It is our goal that this recently adopted format will make our quarterly earnings process more efficient and impactful for the investment community going forward. 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, U.S. and international commercialization, integration and market development efforts, efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition, and results of operations, as well as the expected impact of the COVID-19 pandemic 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.glowcoast.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 our ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available in the investor relations section of our website. for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaucos Chairman and CEO, Tom Burns.
spk00: Thank you, Chris. Good afternoon, and thanks to everyone for joining us today. Today, Glaucos reported second quarter net sales of approximately $72.7 million, down 5% year over year on a constant currency basis, but up 9% sequentially, versus the first quarter on a constant currency basis. As a reminder, the second quarter represents a challenging year-over-year comparable for many in the MedTech industry, but in particular for Glaucos. We are raising our 2022 net sales guidance range to $275 million to $280 million versus $270 million to $275 million previously. Given our solid execution globally, better-than-expected second quarter results and latest forward outlook. From a commercial perspective, we continue to be pleased with the execution of our strategies and the resiliency of our U.S. combo cataract franchise in the face of the reimbursement headwinds thus far in 2022, with our glaucoma, U.S. glaucoma franchise delivering strong sequential growth of 13%. During the latter part of the first quarter, we launched our Eye Access device, a novel instrument with features that allow customers to perform goniotomy procedures. Surgeon adoption and utilization of iAccess continues to grow, and market feedback remains positive. During the latter part of the second quarter, we also commenced initial commercial launch activities for iPrime, our innovative new viscoelastic delivery device. While we remain in the very early stages of iPrime's controlled launch, This platform adds to our expanding portfolio of unique solutions designed to grow and improve treatment options for our surgeons, customers, and patients. Our international glaucoma franchise once again delivered quarterly record sales despite significant foreign exchange headwinds as we execute our strategies to drive deeper penetration and broader adoption of MIGs around the globe. And within our corneal health franchise, we continue to focus on access for keratoconus patients suffering from this rare disease. We're investing in additional commercial payer market access coverage in response to sporadic issues that have emerged in 2022. On the development front, we continue to advance our pipeline. Following the recent clearances and commercial launches of iAccess and iPrime, we're delighted to announce today that we have received FDA 510K clearance for iStent Infinite, our novel three stent injectable system designed to provide foundational 24-7 IOP control for glaucoma patients. This FDA clearance represents a significant milestone for Glaucoast and the MIGS market as the first ever microinvasive implantable device indicated for use as a standalone glaucoma treatment. Supported by strong pivotal data highlighting favorable safety and effectiveness We believe iStat Infinite may provide ophthalmic surgeons with a compelling new treatment alternative in a standalone procedure for patients with open angle glaucoma uncontrolled by prior surgical and medical therapy. We're preparing to commence initial commercial launch activities for this promising technology later this year. Our clinical and regulatory teams also remain hard at work advancing pre-submission activities for iDoseTR and Epioxa, respectively. and we expect to be in a position to announce top line phase three data for IDOS-TR later this year. In terms of our earlier stage pipeline, we are happy to announce we completed patient enrollment in our ILLUSION phase two clinical trial for tri-eye disease during the second quarter. We also expect to complete patient enrollment for our ILLUSION phase two clinical trial for presbyopia during this third quarter and we anticipate initial data readouts for each of these trials by early 2023. We are now in the midst of several new product launches and are planning for a robust cadence of new droplets platform and product introductions over the coming years that have the potential to fundamentally transform glucose over time and meaningfully advance the standard of care and improve outcomes for patients suffering from site-threatening diseases. As such, we are continuing to invest in Glaucos to scale our team and to advance our mission to transform vision. We are excited about our prospects and confident in our ability to execute our plans in the years to come. So with that, I'll open the call to questions. Operator.
spk06: 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 pause just a moment to compile the Q&A roster. And we'll take our first question from Andrew Brockman at William Blair.
spk04: Hi, guys. Good afternoon, and thanks for taking the question. Maybe just to start here on iDose, appreciate all the commentary that you provided and your short remarks, Tom. But I guess as we sort of sit here mid-September, 13 months after the last patient enrolled that last form of the trial, can you just sort of level set up on how you're thinking about that pipeline opportunity and your confidence level that will be successful? And I guess as a follow-up there, can you just talk about the scorecard that you're going to be looking at to evaluate the success beyond the top-line data, anything in particular that you'll be looking at in the study? Thanks.
spk00: Yeah, happy to take the question. So it's important to review just how successful this product has been. If we look and kind of scrutinize what happened in the Phase 2b data results that we recently announced earlier this year, we found that that 70% of patients were well controlled on IDOS with the same or fewer topical IOP lowering meds at 36 months. And many of these patients were on two or three meds at pre-screening. The average, the mean IOP reduction at 36 months for the IDOS group in these various scenarios ranged from 8.3 to 8.5 millimeters of mercury. So really sustained reductions in interocular pressure. So we were invariably pleased that And by any analysis, the IDOS-TR performed similarly to Timolol 36 months in terms of mean RP reductions, but with far fewer topical medications versus Timolol. So those were the kind of top-line efficacy results. I think it's important, too, to then say, okay, well, what happened on the safety side? And the product was extremely well-tolerated. We found no ocular hyperemia. We found no periorval fat atrophy. And importantly, we saw really no clinically significant corneal endothelial cell loss versus tenolol control. And only one instance of hyperchromia or iris color change. And so these are significantly powerful safety factors for this device. And so when we look at what the appetite that's occurring in the marketplace, there has always been a substantial increase kind of an underlying appetite for a sustained release medication that could provide 24-7 control of glaucoma because noncompliance is so ubiquitous and such a rampant cause of the underlying progression of glaucoma disease. I think this product represents an incredibly different paradigm change to be able to treat. It's kind of a simple injection as a standalone procedure. I expect that it will be used to be able to overcome issues of noncompliance in glaucoma, issues of allergy with the disease state, issues of patients who have underlying ocular surface disease so you don't have to continue to pour topical agents that have toxic preservatives in the formulation on the surface of the eye. There are a number of different places that we think this product will be used. And importantly, we do believe that the use of iDose could become kind of a nice complementary product for the use in combination cataract for those patients who have comorbid glaucoma. So it's exciting. I think you already see what's happened with Allergan. They've introduced their Durista product. You can see the strong appetite and the uptake of that product. And the product is a novel, innovative product, but it does have some flaws. And as we know, one of the conditions of the label was it was restricted to a one-time use due to the relatively high rates of corneal endothelial cell loss. I'm hopeful and do not expect to see that because we tracked the corneal endothelial cell loss in IDOS for two years as part of the Phase 2B clinical trial. And again, we saw no clinically significant corneal endothelial cell loss. In addition, we're doing a cohort of patients that We'll look at exchanging the iDose in situ as part of the, once they've implanted the product as part of the clinical trial. And we're following a cohort of patients, and we expect that data to be prepared and submitted as part of our NDA, which, if favorable, will give us the right to be able to exchange and move forward and use this product sequentially over a far longer period of time once the initial product has been depleted of medication. So many of you are starting to do your channel checks. You're finding a strong appetite. You're finding excitement in the ranks. We expect to be able to enter with that tailwind behind us. I think Allergan, as a good marketer, has done and set a good predicate for us, introducing their Darista product, which primarily designed to last four months in the eye, and it reaps over a $2,000 J-code ASP. When I see that, that gives me a strong backbone for introducing this product at a fair and productive rate for the business. So we're excited. I think the important thing you heard in my opening comments is I've given direction from the beginning that we would publish data either by year end or by early next year, and I'm moving that up to by year end and hopeful to get this data in the hands of investors and analysts in a very short period of time.
spk04: Very, very helpful. Thanks for all that color. Maybe if I could just switch to iSent Infinite quickly. Congrats on the approval there. What can you tell us about some of the initial sort of commercialization efforts and market building efforts that you'll be putting out there, and how should we be thinking about uptake later this year and into 2023 in light of that proposed facility rate for 2023? Thanks.
spk11: Sure, Andrew. It's Joe. I'm happy to cover that. Obviously, we're excited about receiving the FDA clearance, as Tom mentioned, another chance for us to pioneer the market with the first ever microinvasive implantable device for standalone glaucoma treatment. So we're enthusiastic here about that launch. As it relates to timing, any time you receive an approval, you have a series of steps to finalize labels and sterile approved inventory and training logistics in the form of a launch plan. So we've been hard at work for the better part of a year preparing for this moment. I would expect that for all intents and purposes, you know, you'll see soft launch activities as we kind of exit the third quarter and head into the fourth. So that should give you a sense of that timing. You referenced, obviously, the facility fee and some of the proposed rules there. And, you know, I think on that I'll just say that while we have work to do, we've been here before and we're already hard at work on that front.
spk01: Thanks, guys. We'll move next to Chris Cooley at Stevens.
spk09: Good afternoon. Congrats on the great quarter, and I appreciate you taking the questions. Just two for me, if I may. First, just as a follow-up to Andrew's questions, Tom, I appreciate all the color you provided on iDose, but I was hoping we could maybe get a little bit more granular on the reimbursement outlook and the pathway there. Obviously, Darista provides a predicate in the early stages, but you... we would think would have a longer duration of effect when we think about high-dose TR. Could you just kind of walk through that pathway for us and what you think we could possibly envision when we think about reimbursement for the device? And secondly, just thinking again here, looking at this deck, which again, I'll have to commend Chris for it. It's a great piece of work. But as we look at that pipeline, increasingly this looks like a pharmaceutical company, much like the old Allergan. And so I'm just kind of curious about the next level of investment that you're proceeding to undertake. You've already obviously built out the bench from an R&D perspective, but what do you start to need to bring on board from a sales and marketing reimbursement, kind of ClinDev type aspect, and when does that start to kick into the P&L? Thank you.
spk00: Yeah, Chris, I'll be happy to take your questions. So the first question that you talked to me about was high dose and reimbursement. So as you know, we've already, I think, set the table by applying for a category three code with the AMA CPT committee. We're successful in getting that code established. That code then, right now it's under current exclusion, so it doesn't be corrupted by people that would put data in that category in the hospital. And so what we'll do is we'll open it up with CMS just prior to commercial launch. And so what we'll do, much like we do with iSite Infinite, is we'll have to establish and have the different MACs crosswalk the perioperative procedure of putting in a standalone device of iDose and crosswalk that to a like category one product to try to establish the highest professional fee. So it's something that we've been quite proficient at in the past and we will continue to do so as we move forward with the iDose. In terms of looking forward for payment in the APC level and with the device, this will be assigned an APC at the time of approval. Now remember, when we have, this will be assigned a J code, and so the J code will be a carve-out for iDOS itself. That product and that J code we'll take forward in the following way. We'll apply for a miscellaneous J code at launch. We'll get that J code, that miscellaneous code, and then HCPCS committees meet every quarter. And so then we'll look at formalizing and getting a formal J code. at the price point that we believe best serves the marketplace subsequent to launch. The APC assignment will be much like happens with iStent or iStent Infinite. We'll get an assignment. We'll see if we like it, whether or not we need to reengage with CMS or if we sit tight. And remember, that APC assignment will be then wholly owned by the facility because the IDOS will be carved out from that So it puts the facility in a nice position of able to achieve profitability for doing these devices. So that's a look. I think I've answered your question fully both on the professional fee side and on the facility side for iDOS. Again, Durista has been set at a rate of about $2,000. designed to last for four months. I don't want to give any indication that we will price proportionally based upon length of therapy, but you can see that I have a lot of open field running in being able to establish a price point for iDose, which by the Phase 2b data appears to be lasting many, many months. And so to your second question, you were talking about pharmaceutical business. I think you need to bifurcate this and the approach into really two sections. Surgical pharmaceuticals, and by those I would list iDose, iDose T-Rex, iRock if we're successful bringing that forward. Products like Crosslinking, which really are a surgical pharmaceutical. And these are buy and build pharmaceuticals that can be handled and established by our current sales force. And this is where we really reap the reward of investing in our sales force and using it to scale. by adding additional products, both devices and surgical pharmaceuticals. When we get into the retail side of the pharmaceutical business, you know that's a very different animal. So when we look at topical applications of transdermal approaches like our Iolution, which would go through pharmacy and wholesale channels, that's where we'll need to establish a secondary sales force to be able to approach and market those products. We've had substantial experience in the past in doing so. Make no mistake, we are confident we will establish the best teams and launch much like we have on the surgical device and pharmaceutical side, but we will need to bifurcate and have separate sales forces to do that. I think that answers your question.
spk01: Thank you.
spk06: We'll move next to Larry Bagelson at Wells Fargo.
spk07: Hi, this is Charles on for Larry. Thanks for taking the question. Just a couple on iPrime. First, I've got to ask about, looks like Canal Plastic didn't get the device intensive in the rule there. Do you think that's possible that could change in the final rule? And then second, maybe just if you could talk a little bit about how long you might think that the initial controlled launch from iPrime might last. Thank you.
spk11: Sure, Charles. This is Joe. I think like most things on reimbursement, we'd hesitate to speculate. It's clearly on the table up and through from the proposed rule through to the final rule. So entirely possible that that could happen as a part of 66174. You know, I think as it relates to the launch, as we mentioned, we've commenced the initial very early commercial launch activities in the quarter with our customers, and we're going to continue down that path. I don't think typically in these situations there's a single moment in time where it changes dramatically. It continues to sort of expand one wave at a time until we feel like our customers are proficient with this new option.
spk01: Thank you.
spk06: We'll go next to Ryan Zimmerman of ETIG.
spk05: Thanks for taking the questions. Congrats on the quarter, guys. Tom, I want to ask you a couple questions, and maybe this one's more for Joe, but I also have some high-level questions. So first on guidance, you know, I think about what you've done this year thus far, kind of about 50-plus percent or so for the first half of the year. And, you know, we look at guidance that you raised $5 million at the midpoint. But if you go back to 2019 and the seasonality that we've seen, particularly in the fourth quarter, it suggests a similar run rate as what we saw in the first half of the year in terms of your guidance. And so why doesn't it get a little bit higher for the remainder of the year, particularly in the fourth quarter, just given where you have guidance today? Hopefully that was clear, Joe.
spk11: No, it is, Ryan. I think a totally fair question and one certainly that would anticipate given the analytics that you just, I think, articulated well. Maybe first and foremost, I'm not so sure that in the situation with all the various things going on in the marketplace, product launch otherwise, that I would look at the typical seasonality pattern and say that is a good guidepost or guideline for how to think about our year. In particular... And while I certainly follow the math, I think some of the things that you have to think about in the second half as we evolve here, foreign exchange has certainly emerged as a pretty material headwind, not just for us, I think for everyone. And you think about how that transpired over the course of the first quarter and then really strengthened as a headwind in the second quarter and certainly at the end of the second quarter entering into the third. You have to factor that in when you're trying to think about these things. The second thing I would say that, you know, when you think about second half versus first half is that you've heard us say many times we think we have a ton of respect for Alcon. We think they're a formidable competitor. And we expect that they'll continue to get their sea legs as the year progresses, both, you know, here in the U.S. but also internationally. So, you know, beyond that, the factors are things that you've heard us talk about before, right? The ongoing impact of the CMS pro fee cuts, account staffing, the types of things you probably heard from other companies as a part of this earnings season, some of the commercial payer volatility dynamics in the Cornell Health side. You kind of put all that together, and I guess the way we looked at this coming into the call here is that we're pretty pleased to be able to raise the full year guidance again, right, and to be able to pass through really the entirety and a little bit more of the beat we just had in the second quarter given sort of all that macroeconomic and specific headwinds that we face.
spk05: No, entirely fair, Joe. I appreciate the commentary. And then, Tom, for you, I mean, we've seen so much reimbursement change in the space, right? I mean, the start of this year with codes around, you know, stem-based treatments to now the proposed fees for canal-based devices. And I really would just, you know, appreciate your view of, you know, where – reimbursement, where the reimbursement landscape shakes out, how you think about, you know, the impact of all these moving components and, you know, Glaucos' philosophy, given the multitude of devices that you now offer, how you navigate that in such a, you know, landscape that is in flux.
spk00: Well, it's a good question, Ryan, and it's something that I can assure you I think about almost daily. As we look at the shifting winds, a couple things that are important is that some of the kind of transitions passed, right? So now we've moved into a Category 1 procedural code with a combination cataract procedures. We know now where we stand. We were really pleased. We were able to carve back what were some significant draconian cuts that happened last year, and we fought hard, and I think valiantly, and we're able to really claw back, particularly on the APC side, and be able to preserve really a fundamentally profitable procedure for the providers to be able to use the iStent device. And so that's been really important. Whenever you create new markets, we have to go through these growing pains with these new codes. And so we'll do so with iStent Infinite. We'll spend the next six to nine months really going into each of the MACs and be able to try to convince them to crosswalk this over to a like procedure that we feel appropriately represents the RVUs for the procedure. It's something that we believe we're good at, but it's something that takes a lot of time and muscle and patience. And there will be episodic setbacks in the process of doing this, much like there have been as we built the MIGS marketplace. We'll see the same thing with iDose on the professional fee side. Although I think that once we settle on a nice and infinite, I expect that to be more streamlined and efficient moving forward. But that will be kind of a sideshow to the approach that we take with getting the J-code for the device. The J-code really is subject to our own procedural pharmacoeconomics of what we think is a fair position on pricing in the marketplace, what we think we can favorably represent and stand behind. And once we do present that, we will then get that through HCPCS and get a formal J-code that's not subject to review. I want to remind everybody as well, with the T-Rex product that follows, because the T-Rex has substantially more API on board, approximately twice the amount, the way that CMS works is they will pay by basically the microgram of the product that's resident in the can itself of the iDOS device. And so that gives us legs as we move forward on payment and I would say consistency and predictability for investors as they think about that going forward. So this is something that when you build new marketplaces, these are the growing pains that you go through and that you take. We're a leader. We're the pioneer. We're at the front end. We are creating this marketplace. We'll create the sustained marketplace for eye dose therapy. We're creating a new marketplace in Keratoconus with cross-linking and its subsequent generations. We've become good at it. It's a difficult process, but we're at it every day, and we think the payoff is there, and we're already seeing the payoff as we build value in this marketplace.
spk01: Thanks, Tom. Appreciate it. Okay.
spk06: We'll move next to Matt O'Brien at Piper Sandler.
spk01: Hey, this is Phil on for Matt. Can you hear me all right? Yes. Hello? Yeah, Phil, we can hear you. Oh, sorry.
spk12: Thanks for taking my questions and congrats on the quarter. For my first one, on the dual procedure reimbursement dynamic, What are you seeing in terms of that stain power? More specifically, the Palmetto LCD recently came out with language surrounding goniotomy, stating that 65-820 should not be used in conjunction with other ankle surgery, stents, implants, even if the incision is minimal or incidental. So what's the stain power here of that dynamic going forward?
spk11: Thanks for the question, Phil. I think, first of all, it's an LCA, not an LCD. It's a technical difference, but it's important. I think any time you have two separate devices, two separate complementary procedures, and two distinct codes, surgeon discretion on what they deem medically reasonable and necessary should ultimately govern. I think that's the way most medicine is practiced and reimbursed throughout, not just in ophthalmology. I think on this one, the AEO is assessed this quite thoroughly given the growing trend that for years has been expanding here. I mean, it's ultimately a sight-threatening progressive disease where surgeons want to utilize multiple tools to optimize the clinical outcome for the patients. So AOS looked at this. They've come out both in March of 2022 with their bulletins around the utilization of canaloplasty in combination with stents and cataracts and then more recently with their goniotomy fact sheet that we think is quite clear. So ultimately, our goal here is to provide surgeons with the best tools that are minimally invasive to maximize their benefit to patients and hopefully grow the overall market while doing so. And as we navigate that, we'll continue to sort of work through things that pop up, whether it's Palmetto or other areas, on behalf of our customers and patients.
spk12: Great. Thank you for that, Culler. And just a quick follow-up here. You know, I assume some competitive trialing went on in the first half as surgeons became more aware of reimbursement changes and things of that nature. What are you seeing on that front? You know, others leave Glockhost and then, you know, some come back after trialing other products. Thank you.
spk11: Well, I think anytime you have something the like of the changes that we saw in the CMS professional fee, coming into the year, you're gonna have some disruption in market trends. And I'd say, sort of all of the above, right? You see customers who will try and trial other alternatives and come back recognizing that stent-based solutions provide the best long-term therapy for their patients. And you also see that same type of try and trialing as we launch our own products, new products into the marketplace. I think we're well-positioned. We've got a full portfolio of solutions for those physicians who want to try other alternatives for their patients, and we'll continue to navigate those dynamics as we move forward.
spk12: Awesome. Thanks for taking my questions, and congrats again on the corner.
spk01: Thanks, Bill.
spk06: We'll take our next question from Tom Steven at Stiefel.
spk10: Great. Hey, guys, thanks for the questions. If I can start on IDOS. Sorry if I missed this, but has the year-end 22 NDA submission target changed at all? I think the commentary in the press release was altered a bit. And I guess if so, is there something specific informing that change that you can call out? Just want to clarify the path forward. And then second on IDOS, can you just talk a bit about site of service, I guess. How should we think about whether or not this can move potentially beyond the OR?
spk00: Yeah, okay, Tom, I'll be happy to take the latter question first. And as we've said all along, The eye dose device today is a highly benign procedure that goes through a very, very small incision. And so one of the things we've been actively approaching and working on for some time is being able to come up with an applicator that can be able to go through potentially a small enough incision where you can keep the pressure in the eye and be able to not have what's called dehiscence where the aqueous humor will flow out of the eye and you're able to complete the iDose implantation with just a single injectable procedure. And if we are able to be able to execute and have that happen and we're making substantial progress, then I do see the fact that this can be able to move and it's been our strategy from the beginning to offer a product that can be used either in the ASC or eventually in a minor in-office suite. And I think we'll be able to get there with the iDOS product. When we do so, we'll have a couple of codes. We'll have codes in place that pay for the iDOS device and the ASC, which I've described previously. And we'll also have another code that will provide for the use of the iDOS in-office So to the extent that we are successful in creating this applicator, and again, it's been our mission from the beginning, we'll be able to provide that. Now, having said that, right now I'm agnostic about where this product is used. There are many surgeons that are telling me they want to stay and keep this in the ASC moving forward. And so my hope and my delivery would be to be able to provide both options for surgeons over time.
spk11: Hey, Tom, it's Joe. On the first part of your question, I don't think there was anything intended to be in our IR materials press release or otherwise that would have made news with respect to the timing of an IDOS submission. We've been talking around year-end for a while. I think actually the only thing that we said was the pre-submission activities are ongoing, which you'd expect, and probably the only news in Tom's prepared remarks that we referenced was that he's prepared to provide the IDOS data prior to year-end. which was a little bit moved forward from some of the prior guidance that we had given.
spk10: Got it. So just kind of blocking and tackling in terms of the pre-submission items for IDOS, nothing specific to call out?
spk01: No.
spk00: Yeah, I would say that. And further, Tom, if you take anything from my remarks, the fact that I've moved up from saying that we would have this by early next year and publish the data, again, I'll restate that we'll be able to publish this data before that. I want to be able to publish it before the end of the year. So again, I think that should show you things are on track and investors' appetites have been whetted for some time. We plan to deliver that data.
spk10: Perfect. That's helpful. And then my second question, just on U.S. glaucoma, I mean, you beat our estimates handily. What surprised you most to the upside? Because I think clearly things are going well year to date, I guess. You know, what I'm trying to get at would you say the worst might be behind us in terms of the pressure points? Maybe you've now entered a point where things are kind of hitting a steady state or maybe even improving. Hopefully that makes sense.
spk11: It does, Tom. I think we're halfway through the year. I think we've been pleased with the resiliency and the stability of of the core combo cataract stent franchise. In the second quarter, we were pleased with what I'll still characterize as early contribution from iAccess and overall the continued stability in the pricing environment. I think to the core of your question, I think we've had two pretty good data points this year in Q1 and Q2 around what life can look like after the pro-fee cuts. But I think it's a little bit early to sort of extrapolate that into a victory in terms of how this will continue to transpire. And every day is a day that we're out there making sure that patients and surgeons are aware of the benefits of our products and making sure that we maximize the opportunity there.
spk01: Great. Thanks, guys. We'll move next to Zach Wiener at Jefferies.
spk08: Hey, thanks for taking the question. I just wanted to touch a little bit on that last question. Can you talk about some of the inflationary pressures and surgical throughputs that you've seen through the quarter and then, you know, if you're seeing any challenges from staffing as well?
spk11: Yeah, I mean, I think that we're not immune to what you've probably heard from multiple companies over the course of this earnings season. I think... a combination of dynamics, some inflation, some related to COVID, some related to the job market shifts that have happened, is clearly causing disruption in the labor market and in staffing for hospital administration, hospital techs, the support that helped make these ORs and ASCs run at optimal efficiency. And we hear often from our customers over the course of this year, including recently, around challenges they're having and maintaining that staffing, maintaining those OR lanes running at max capacity. So I think it is a dynamic that persists across the healthcare landscape and certainly within ophthalmology as well.
spk01: Yeah, that's helpful. Thank you. And we'll go next to Alan Gong at J.P. Morgan.
spk03: Hi, this is Rohan actually on for Alan. I just had a question about kind of your expectations for OpEx going forward. You had some pretty healthy step-ups in SG&A and R&D in the quarter. So how do you think or how do you think we should think about spend kind of into the end of this year and obviously not, you know, obviously not providing formal guidance, but 2023 as well, especially kind of what's needed for Infinite and ultimately iDose?
spk13: Yeah, Rohan, thanks for the question. This is Alex. I'll try to address that. So, you know, we did report it in our financials, $90 million, $91 million. And as you know, included in that number is $10 million related to this licensing agreement that we did in the second quarter. So we're going to, you know, the things we'll talk about now, let's just take that $10 million out so that we're sitting at about an $80 million spend in Q2. If you think about where we've come from this year, the first half we put up, about $150 million. And in previous quarters, we've talked about our profile being around at $300 million or north of $300 million OpEx company. And if you just think about that, what will happen in the next couple of quarters, it's probably about the same as we saw in Q2, maybe a little step up so that your OpEx or our OpEx for the year is probably in the $310 million range, maybe give or take a few million here or there. The reasons for that are what might be what you expect, right? We have continued investments in our R&D programs, clinical regulatory activities that are ongoing with our pipeline and what we're doing, as well as on the commercial side. We're continuing to enhance that organization.
spk01: We've got new product launch activities happening and things of that nature. Great. Thank you.
spk06: And that does conclude our question and answer session for today. At this time, I'll turn the conference back over to management for any closing remarks.
spk00: Okay, thank you so much, all of you, for your time and attention today, and we hope everyone is staying safe. And we also thank you for your continued interest in Glaucos. Goodbye.
spk06: And that does conclude today's conference. Again, thank you for your participation. You may now disconnect.
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