Welcome to Glaukos Corporation Second Quarter 2022 Financial Results Conference Call. Copies of the company's press release and quarterly summary document both issued after the market close today are available at www.glaukos.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. [Operator Instructions] 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. Joining me today are Glaukos' 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 the 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 for 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 very brief prepared remarks and quickly transition into a question-and-answer session. It is our goal that this recently adopted format will make our quarterly process more efficient and impactful for the investment community going forward. [Operator Instructions] 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, our products, pipeline technologies, U.S. and international commercialization, integration and market development efforts, the efficacy of our current and future products, our 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 Investors section of our website at www.glaukos.com. Finally, please note that during today's call, we will also discuss certain non-GAAP financial measures, including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos' ongoing results of operations, particularly when comparing underlying results from period-to-period. Please refer to the tables in our earnings press release available on the Investor Relations section of our website for reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos' Chairman and CEO, Tom Burns.

Thank you Chris. Good afternoon and thanks to everyone for joining us today. Today Glaukos 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 Glaukos, 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 board 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 iAccess device, a novel instrument with features that allow customers to perform go anatomy 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 disco elastic delivery device. While we remain in the very early stages of iPrime controlled launch, this platform adds to our expanding portfolio of unique solutions designed to grow and improve treatment options for our surgeon, 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…

Thank you. [Operator Instructions] And we'll take our first question from Andrew Brackmann at William Blair.

Hey guys. Good afternoon and thanks for taking the question. Maybe just to start here on iDose, appreciate all the commentary that you provided in your short remarks, Tom. But I guess as we sort of sit here, mid-September, 13 months after the last patient enrolled, that that last term in the trial, can you just sort of level set up and 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 topline data, anything in particular that you'll be looking at in this study? Thanks.

Yes, happy to take the question. And 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 IIb data results that we recently announced earlier this year, we found that 70% of patients were well-controlled on iDose with the same or fewer topical IOP p[indiscernible] 36 months and many of these patients were on two or three meds with pre-screening. The average -- there the mean IOP reduction at 36 months for the iDose group in these various scenarios range from a 8.3 to 8.5 millimeters of mercury. So, really sustained reductions in ocular pressure. So, we were invariably pleased that and by any analysis, the iDose TR performs similar to timolol 36 months in terms of mean IOP reductions, but with far fewer topical medications versus timolol. So, those were the kind of topline efficacy results. And 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 periorbital fat atrophy. And importantly, we saw really no clinically significant corneal endothelial cell loss versus Timolol control. And only one instance of hyper chromia or iris color changing. 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 kind of underlying appetite for a sustained release medication that could provide 24/7 control of glaucoma because non-compliance is so ubiquitous, and such a rapid cause of the underlying progression of glaucoma disease. I think this product represents an incredibly different paradigm change to be able to treat, the kind of, a simple injection as a standalone procedure, I…

Very, very helpful. Thanks for all the color. Maybe if I could just switch the iStent infinite quickly, congrats on the approval of 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, right, for 2023? Thanks.

Sure, Andrew. Its Joe. I'm happy to cover that obviously, we're excited about receiving the FDA clearance. As Tom mentioned yet another chance for us to pioneer the market with the first ever micro-invasive implantable device for standalone glaucoma treatments. So, we're enthusiastic here about that launch. As it relates to timing, in anytime you receive an approval, you have a series of steps to finalize labels and sterile approved inventory and training logistics and the formal 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'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 that timing. You referenced obviously, the facility fee and some of the proposals there. And 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 to work on that front.

Thanks guys.

We'll move next to Chris Cooley at Stephens.

Good afternoon. Congrats on a great quarter and appreciate you taking the questions. Just to 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 can maybe get a little bit more granular on the reimbursement outlook and the pathway there? Obviously, duresta provides a predicate in the early stages, but you would think would have a longer duration of effect when we think about high iDose TR? Could you just kind of walk through that pathway for us and what you think we could possibly envision and we think about reimbursement for the device? And then secondly, just thinking again, here looking at this deck, which again, I'll have to commend Chris for, it's a great piece of work. But as we look at that pipeline, increasingly this looks like a pharmaceutical company, like much like [indiscernible]. And and so I'm just kind of curious about the next level of investment that uses 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 clin dev type aspect? And when does that start to kick into the P&L? Thank you.

Yes, Chris, I'll be happy to take your questions. So, the first question that you talked to me about was iDose reimbursement. So as you know, we've already I think, set the table by applying for a Category 3 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 it much like we do with iStent infinite is we'll have to establish and have a different max crosswalk the perioperative procedure of putting in a standalone device of iDose and crosswalk that to a to a like Category 1 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 payments in the APC level and in the -- with the device, this will be assigned an APC at the time of approval. Now remember, when we have this will be assigned to J-Code and so the J-Code will be a carve out for iDose itself that products and that J-Code will take forward and 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 hicks-fix 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 assignments will be much like happens with by iStent…

Thank you.

We'll move next to Larry Biegelsen at Wells Fargo.

Hi, this is Charles on for Larry. Thanks for taking the question. Just a couple on iPrime. First, I got to ask about looks like last year didn't get the device intensive in the rule area. 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 you're the initial controlled launch for iPrime might last? Thank you.

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 that could happen as a part of, of 66174. 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.

Thank you.

We'll go next to Ryan Zimmerman at BTIG.

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, I think about what you've done this year thus far, kind of about 50%-plus or so for the first half of the year. And when we look at guidance, 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 stick out 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.

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. If you – 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 things 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. So -- and you think about how that transpired over the course of the first quarter and then really strengthens the 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 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 here in the US, but also internationally. So beyond that, the factors, the things that you've heard us talk about before, right, ongoing impact of the CMS pro fee cuts, account staffing, 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 corneal health side. You kind of put all that together, and I guess the way we look 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.

That was totally 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 stent based treatments, to now the proposed fees for canal based devices. And I really would just appreciate your view of where reimbursement – where the reimbursement landscape shakes out, how you think about the impact of all these moving components and Glaukos' philosophy given the multitude of devices that you now offer, how you navigate that in such a landscape that is in flux?

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 of 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 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 thought hard and I think the value 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 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 within the next 6 to 9 months, clearly going into each of the next and be able to try to convince them to crosswalk this over to a light 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 had 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 iStent 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…

Thanks, Tom. appreciate it.

Appreciated.

We'll move next to Matt O'Brien at Piper Sandler.

Hey, this is Drew on for Matt. Can you hear me, all right?

Yes. Yes,

Hello.

We can hear you.

Sorry. Thanks for taking my questions, and congrats on the quarter. So my first one on the dual procedure reimbursement dynamics, what are you seeing in terms of that staying power? More specifically, the Palmetto LCD recently came out with language surrounding goniotomy, stating that 65820 should not be used in conjunction with other angle surgery stents implants, even if the incision is minimal or incidental. So it kind of what's the sustained power here of that dynamic going forward?

Thanks for the question, Phil. I think the -- first of all, it's an LCA, not LCD, technical difference, but it's important. I think anytime you have two separate devices, two separate company 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 AO 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 patient. So AO looked at this. They come out, both in March of 2022 with their bulletins around the utilization of canaloplasty in combination with cataracts. And then more recently with the goniotomy fact sheet that we think is quite clear. So ultimately, our goal here is to provide surgeons with the best tools, right, that are minimally invasive to maximize the 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 and on behalf of our customers and patients.

Great. Thank you for that color. And just a quick follow-up here. 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? Others leave Glaukos and then some come back after trialing other products? Thank you.

Well, I think anytime you have something the like of the changes that we saw in the CMS professional fees coming into the year, you're going to 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 the same type of trend trialing as we launch our own products -- new products into the marketplace. So I think we're well positioned. We've got a full portfolio of solutions for those physicians who wanted to try other alternatives for their patients, and we'll continue to navigate those dynamics and move forward.

Awesome. Thanks for taking my questions, and congrats again on the quarter.

Thanks, Bill.

We'll take our next question from Tom Stephan of Stifel.

Great. Hey, guys. Thanks for the questions. If I can start on iDose. Sorry, if I missed this, but as the year-end 2022, 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 iDose? 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 lower [ph]?

Yes. Okay. Tom, I'll be happy to take the latter question first. And as we've said all along, the iDose 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 working on for some time is being able to come up with an applicator that can be able to -- 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 the [indiscernible] where the aqueous humor will flow out of the eye. And you're able to complete the iDose implantation, which is the 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 [indiscernible]. And I think we'll be able to get there with the iDose product. When we do so, we'll have a couple of codes or codes in place that they for the iDose device, and the ASC which I've described previously, and will also have another code that will provide for the use of the iDose in office. So to the extent that we are successful, and 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 to my hope and my delivery would be that to be able to provide both options for surgeons overtime.

Hey, Tom, it's Joe. And 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 respect to the timing of an iDose 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 that in Tom's prepared remarks that we referenced was that, that he's prepared to provide the iDose data prior to year-end, which was a little bit move forward from some of the prior guidance that we'd given.

Got it. So just kind of blocking and tackling in terms of the pre-submission items for iDose? Nothing specific to call out?

No. 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, we stayed there won't 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 then investors, appetites have been wedded for some time, we plan to deliver that data.

Perfect. That's helpful. And then my second question just on US 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. What I'm trying to get at, are -- would you say the worst might be behind us in terms of the pressure points, and maybe you've now entered a point where things are kind of hitting a steady state or maybe even improving? Hopefully, that makes sense.

It does, Tom. I think we're halfway through the year. I think we've been pleased with the resilience and the stability of the core combo cataract stent franchise. In the second quarter, we were pleased with what I'll still characterizes early contribution from iAccess. And in overall the continued stability in the pricing environment, I think to the core of your question. I think we've had pretty good data points this year in Q1 and Q2 around, what life can look like after the prophy cuts. But I think it's a little bit early to sort of extrapolate that into 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.

Great. Thanks, guys.

We'll move next to Zach Weiner at Jefferies.

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 if you're seeing any challenges from staffing as well?

Yes. I mean, I think that we're not immune to what you've probably heard from multiple companies over the course of this earning season, I think, a combination of dynamics, some inflation, some related 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 to 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 it at max capacity. So I think it is a dynamic that this persists across the healthcare landscape and certainly within ophthalmology as well.

Got it. That's helpful. Thank you.

And we'll go next to Allen Gong at JPMorgan.

Hi, this is Robin [ph] actually on for Allen. I just had a question about kind of your expectations for OpEx going forward? There are 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 -- obviously not providing formal guidance, but on 2023 as well, especially kind of what's needed for infinite and ultimately iDose?

Yes, and thanks for the question. This is Alex, I'll try to address that. So we did reported in our financials, 90 -- $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 -- 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 spin in Q2. If you think about where we've come from this year, the first half, we put up about $150 million. And then previous quarters, we've talked about our profile being around a $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 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. We've got new product launch activities happening and things of that nature.

Great. Thank you.

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.

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 Glaukos. Goodbye.

And that does conclude today's conference. Again, thank you for your participation. You may now disconnect.