Glaukos - Q3 2023

Transcript

Operator (participant)

Hello, welcome to the Glaukos Corporation Q3 2023 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 speaker's remarks, there will be a question and answer session. If you would like to ask a question during this presentation, simply press * followed by the number 1 on your telephone keypad. If you would like to withdraw your question, again, press star 1. This call is being recorded and an archived replay will be available online in the Investor Relations section at www.glaukos.com. I will now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Chris Lewis (VP of Investor Relations and Corporate Affairs)

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 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 any strategies and any forward statements or guidance we may make. This guidance or this document is designed to be read by investors for their 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 question, we request that you limit yourself to 1 question and 1 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, our competitive market position, regulatory strategies, and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations on our business and operations.

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 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 Glaukos Chairman and CEO, Tom Burns.

Tom Burns (Chairman and CEO)

Okay, thanks, Chris. Good afternoon, and thank you all for joining us today. Today, Glaukos reported Q3 consolidated net sales of approximately $78 million, up 10% versus the year ago quarter. These Q3 results reflect continued strong performance and execution across our key franchises globally. Given these results and our latest forward outlook, we are raising our 2023 net sales guidance range to $307 million-$310 million, versus $304 million-$308 million previously. From a commercial perspective, strong execution of key strategies within each of our core franchises drove the solid performance. Within our US glaucoma franchise, we delivered sales of $38.1 million on growth of 2% year-over-year, as we experienced more pronounced seasonality headwinds in August, offset by continued strength in July and September.

Consistent with prior quarters, we continue advancing iStent infinite ahead of establishing formal MAC coverage and payment. On that front, just last week, WPS, 1 of the 7 MACs, published an updated MIGS LCD with a future effective date of December 24th, 2023, that provides coverage for iStent infinite, consistent with FDA approval and our reconsideration request. We are pleased with this final outcome as it relates to iStent infinite, but we're disappointed at other aspects of the LCD that severely restricts clinical decision discretion for surgeons fighting a sight-threatening disease. Looking ahead, the remaining 6 MACs have all taken preliminary steps to assess iStent infinite coverage, including 4 through proposed LCDs and 2 with local coverage articles.

We continue to monitor the various MAC processes and policies as they advance and are ultimately finalized in the future, as we remain supportive of expanding broad access to interventional glaucoma tools for physicians and for patients. While we await the release of CMS's 2024 final rules, we remain encouraged that as part of the 2024 proposed rule, the CPT code used to cover iStent infinite in standalone procedures, O671T, was lifted to APC 5492, and the APC assignment for combined cataract plus trabecular bypass procedures, 66989 and 66991, was proposed to move to a newly restructured APC 5493.

If finalized as proposed, we do believe these changes, while positive for our customers and our procedures, may create some transient disruptions to ordering patterns in late 2023 ahead of becoming effective on January 1, 2024. Moving on. Our international glaucoma franchise delivered sales of $20.3 million on strong, broad-based year-over-year growth of 23% on a reported basis and 20% on a constant currency basis. The strong growth was once again broad-based as we continued to scale our international infrastructure and execute our plans to drive MIGS forward as a standard of care in each region and every major market in the world.

While we focused on our near-term execution, we are also accelerating efforts to support one of our founding missions at Glaukos, 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. We continue to lead and work closely with surgeons and thought leaders globally to organically drive this broader revolution in the standard of care, including through numerous events at the ESCRS annual meeting in Vienna in September and the Interventional Glaucoma Consortium in Salt Lake City in October. These efforts will once again be on full display at the upcoming AAO annual meeting being held in San Francisco this weekend.

And finally, our corneal health franchise delivered record sales of $19.7 million on 12% year-over-year growth, including for Photrexa, record sales of $17 million on a year-over-year growth of 18%. As key strategic initiatives implemented throughout the past year continue to take hold in support of this important business. Similar to our U.S. glaucoma franchise, our U.S. corneal health business experienced more pronounced seasonality headwinds in August, offset by strength throughout the remainder of the quarter. Shifting gears to the development front, we continue to prudently invest and successfully advance our robust pipeline of novel, promising platform technologies that we believe have the ability to significantly expand our addressable markets and fundamentally transform our company over time. Starting with iDose, we continue to be encouraged as we work closely with the FDA in their ongoing NDA review process.

During the Q3, we successfully completed the required Pre-Approval Inspection, or PAI, of our new state-of-the-art hybrid pharmaceutical manufacturing facility, notably with no Form 483 observations. For a company going through this type of rigorous pharmaceutical review for the first time, I could not be more pleased with this unblemished outcome, and would like to recognize our operations, development, and quality teams that drove this result. Based on our productive mid-cycle review meeting with the agency held in August, we remain confident in the agency's decision by the PDUFA date of December 22, 2023. Alongside this, our teams are increasingly advancing preparation and planning efforts to support the iDose commercial launch, targeted for early next year, including a robust set of peer-reviewed literature expected to be published over the remainder of this year and into 2024.

Our robust publication plan includes 4 manuscripts that have already been submitted to leading journals and at least 5 others that are planned for submission. Shifting gears to Epioxa, our next-generation corneal cross-linking therapy, we continue to advance patient follow-up in the 2nd phase III pivotal study and remain on track for our targeted NDA submission by the end of 2024. Beyond iDose and Epioxa, we recently commenced a PMA pivotal study for iStent infinite in the mild to moderate glaucoma population, and expect to begin first-in-human clinical development for one of our retinal programs, along with a phase IIA study for iLution Travoprost by year-end, respectively. 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, and as we have discussed, we continue to prioritize the cadence of our investments as we strive to strike the right balance of risk-based spending and our capital position now and in the future. We are pleased to see evidence of this again in the Q3, as our non-GAAP SG&A and R&D operating expenses grew at a modest 1% sequentially, reflecting some of the adjustments we've made in our earlier-stage pipeline programs as we continue to prioritize our resources ahead of the anticipated iDose commercial launch early next year. So in conclusion, I am pleased with the continued execution and performance in our business as we continue to successfully advance our mission to truly transform vision by pioneering novel dropless platforms that can meaningfully advance the standard of care and improve outcomes for patients suffering from sight-threatening chronic eye diseases.

Our foundation is strong, and we are well positioned as we enter into what should be a transformational period for our company in the years ahead. So with that, I'll open the call to questions. Operator?

Operator (participant)

Perfect. Thank you. At this time, I would like to remind everyone, in order to ask a question, press *, then the number 1 on your telephone keypad. We'll pause for one moment to compile the Q&A. All right, our first question comes from the line of Tom Stephan. Tom, please go ahead.

Tom Stephan (Associate VP in the Healthcare Sector)

Great. Hey, guys. Thanks for the questions. I wanted to start off with the LCDs. Maybe if we assume the remaining 4 MACs align with WPS, can you guys just talk first about the ways the company, from a strategic perspective, is aiming to capitalize on any of the changes or just potential uncertainty that probably will ramp in the market next year? And then maybe qualitatively, you know, how should we be thinking about any sort of net tailwind for Glaukos next year from the LCDs?

Joe Gilliam (President and COO)

Hey, Tom. Thanks for the, the questions. It's Joe. I'll start off on this one. You know, from a macro standpoint, I think, you know, really, I would reiterate some of what Tom said in the prepared remarks. First and foremost, at least in the first LCD that we've seen from WPS and what we would likely expect to see from at least the other 4 MACs that seem to be in a similar place, is most importantly, coverage for iStent infinite. For us, it really starts there, and that was the totality of our efforts around this and trying to make sure that patients were getting access to iStent infinite, as intended.

Thankfully, on that front, WPS, and hopefully other LCDs, established that proper coverage that we requested for iStent infinite. You know, beyond that, obviously, we're disappointed in the context that the activity or the final LCD as drafted really takes a step towards removing that clinical decision-making from the clinician's hands. You know, in our... For us, that's gonna be something that we have to work on for some time, try to make sure that we can play our part in getting those decision-making capabilities back in the hands of the surgeons who are making the call on behalf of their patients. As you think about it, for us, you know, you asked quantitatively how we think about it.

I think, you know, in 2023 and the remainder of this year, we expect some short-term ordering volatility, you know, headwinds, if you will, in December, especially, as some accounts may prioritize non-stent-based procedures ahead of the final effective dates for a variety of reasons, but most importantly, probably burning off any inventory that they have on their shelves ahead of a change in policy like this. And as we turn into 2024, you know, what I'll say is we're evaluating the impact, and we're gonna continue to do so as these other LCDs are finalized.

I think I'd probably just say I'd caution investors in the interim, as the WPS LCD, it does contain a lot of puts and takes as it relates to, you know, our product portfolio, and we really have to go through the totality of that before we can comment with any more specificity on what it may or may not mean for 2024 and beyond.

Tom Stephan (Associate VP in the Healthcare Sector)

Got it. And maybe 1 quick follow-up. When you talk about kind of the short-term volatility, are you starting to see that? Or, I guess, what's informing that view? And then maybe I can get 1 more quick follow-up.

Joe Gilliam (President and COO)

Yeah, I wouldn't say that we're seeing it in that way. This is more of an anticipation thing. I think anytime you go into a change in reimbursement policy like that, and we've seen this in the past, where things have adjusted, obviously, the customers themselves have to adjust what their either, you know, treatment algorithms are or the stock they have on their shelves. Most are not going to sit around and can hold that inventory past those effective dates, is what you'd expect. And so as they get closer to that date, we certainly would anticipate that they'll use that inventory up.

They'll go to more of a just-in-time kind of ordering process, and then they'll adjust as, you know, the new year starts to unfold, and they change whatever algorithms they have from a treatment perspective.

Tom Stephan (Associate VP in the Healthcare Sector)

Got it. Maybe I'll call this question 2 B. But pivoting to iDose, I wanted to ask about just doc trainings. Joe or Tom, any sense you can give us for how to think about the ramp in 2024? Will it be kind of deliberately methodical early on as you work through establishing full reimbursement? And then, what's kind of a reasonable annual cadence of doctor trainings in the first couple of years, sort of as we refine our models? We looked back at the iStent training ramp. There were periods early on that I think you, you know, trained 700-800 physicians per year, and that's when MIGS were much less well-established. But now you have, what? 5,000 plus MIGS-trained doctors.

So for iDose, is it reasonable to think doctor trainings could approach 1,000 per year for the first couple of years? Thanks for taking the questions.

Joe Gilliam (President and COO)

No problem, Tom. You stuck 3 in for 1, but we'll, we'll go ahead and honor it.

Tom Stephan (Associate VP in the Healthcare Sector)

Sorry about that.

Joe Gilliam (President and COO)

So no, it's all, it's all good. From a doctor's standpoint, we're gonna take the same approach we've always taken. And so I wouldn't say even just the beginning, I'd say for the entirety of 2024, we're gonna be methodical as it relates to driving superlative outcomes in the case of the doctors that we're training on iDose. We've always done it that way. Now, obviously, in those early days, let's call it in the, you know, the H1 of the year, that'll be even more the case, and that we'll go out to a handful of surgeons that we know work well in these early stage, you know, training situations.

Make sure that we've nailed down the training algorithm for our sales force before we start to expand from there. I think the other, you know, key gating item that I would point to as it relates to the pace of training is reimbursement itself. So as you transition from a miscellaneous code to a permanent J code, as you start to establish more regular and recurring payment on the professional fee, and even the facility fee side associated with iDose, more and more surgeons and their practices will be ready, willing, and able to be trained, and so those things also play a role in this. You know, you referenced historical statistics, and that, though they're accurate.

I think at our peak, we were training somewhere between 700 and 800 docs a year, on the iStent technologies, first generation, a lot of which was teaching them, angle-based surgery. As we move forward, I think that lift on the angle will be a little bit less. So we would, you know, have expectations that as we hit a steady run rate, that we can train, you know, more doctors than that 700 to 800 historical run rate, with iDose. But to get more specific in that, it's hard until we really get at that stage of the deployment.

Tom Stephan (Associate VP in the Healthcare Sector)

Very helpful. I'll keep it to 1 next time. Thanks, guys.

Joe Gilliam (President and COO)

Thanks, Tom.

Operator (participant)

All right. Our next question comes from the line of Ryan Zimmerman from BTIG. Ryan, please go ahead.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

All right. I'm gonna stick to the rules here and ask just the 1 and the follow-up. So number 1, I'm gonna ask for Tom. Tom, you're in the process, I think, of having conversations with FDA about labeling iDose. I don't know what you're comfortable saying, but what can you say in terms of kind of where you're at and the early read on what the label could look like for iDose?

Tom Burns (Chairman and CEO)

Yeah, Ryan, I'm happy to respond, and as you, I think you stated earlier, these would be highly preliminary, and most of these would be based on our debriefing from the mid-cycle review that we had mid-year. So, what I will tell you is we have yet to receive a draft label. So as we said previously, while we're confident in the strength and robustness of our clinical data, you never know for sure where the label will land and whether the FDA will view the data using the same prism as we do until that process is finalized. What I will tell you is that we remain confident that we're tracking towards the PDUFA date of December 22, but that's really as far as I can assure you at this point.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Okay. Fair. I will have to wait till the 22nd of December. Second question for me, just with the LCDs likely finalized from what we saw with WPS the other week, I'm less concerned with how this impacts your surgical business and more interested in how you think about it de-risking the iDose launch next year. So, you know, how does it change your calculus on iDose and what you need to achieve next year? I mean, when we spoke kind of mid-quarter, you know, you were messaging that H2 2024 really would be, you know, the inflection for iDose. But I have to imagine that this, this takes some pressure off of the H1 of the year, because there is some benefit that will come from the LCDs.

And so, you know, how has that, in the past week, maybe shifted your thinking on the cadence for iDose next year?

Joe Gilliam (President and COO)

Yeah, Ryan, I think I don't know if I would make that far of a leap in the context of the LCD as it relates to iDose. I think the key drivers of iDose in 2024 go back to a little bit more of what I said previously. It's really gonna come down to the pace in which we can and are comfortable training these doctors, and the pace in which you establish predictable, recurring reimbursement, particularly on the facility and the pro fee side alongside of that. So you wanna get through the miscellaneous J or C code phase. You wanna get through the initial stages of determining regular and recurring professional fees, and that you're gonna get paid on the facility side.

I think those are the things that ultimately shift a lot more of the, you know, shifting from the walk into the to the jog, into the run, to the back half of the year versus the H1. You know, it is possible that across all of our portfolio, there'll be incremental demand associated with procedures, whether that be stenting. But I think iDose probably won't benefit from that until certainly later in the year, going into 2025.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Okay. Thanks for taking the questions.

Joe Gilliam (President and COO)

Thanks, Ryan.

Tom Burns (Chairman and CEO)

All right. Our next question comes from the line of Larry Biegelsen from Wells Fargo. Larry, please go ahead.

Larry Biegelsen (Senior Analyst)

Hi, this is Charles on for Larry. Thanks for taking the question, and congrats on the nice quarter. I want to just follow up on the LCD again. So I, I appreciate what you, you talked about there's, there's puts and takes before, and so maybe wanted to, to follow up on, to make sure we understand the, the positives and negatives of that. So on the positive side, I mean, it's iStent inject, and maybe the competitive procedures like canaloplasty and goniotomy, maybe some of those stents pick up some of those. But on the negative side, it sounded like we read that stents are only covered as a second-line therapy. The language seems to eliminate the stacking of multiple MIGS procedures. Is the... Are those the puts and takes you're talking about for iStent there? Can you confirm that?

And then I have a follow-up.

Joe Gilliam (President and COO)

Okay. Yeah, Charles, I think first and foremost, anytime you have a policy like this, there's always some inherent ambiguity in it. That's the first line. I mean, I think exactly how the MACs will adjudicate these policy changes will matter over the course of, you know, the next several years.... And that's hard to always know from, you know, the literal reading of a policy that comes out like this. So I think that's 1 factor that folks have to take into consideration. You know, you referenced obviously some of the adjustments that they're proposing or finalizing as it relates to canaloplasty, some of the shifts on the goniotomy side.

When it comes to the combining of procedures, it's correct, the WPS LCD does restrict the clinical decision-making as it relates to the combining of these procedures. And, you know, we think it restricts the options that surgeons have in the fight against what's a multifactorial disease, using tools that have complementary mechanism of action. That is one of the puts and takes that have to be considered here, and certainly is an offset to any, you know, pickup of share that you might anticipate associated with the restrictions that are being placed on canaloplasty and goniotomy, and something that we're going to take our time to assess from an overall standpoint.

Larry Biegelsen (Senior Analyst)

Okay. Thank you. And then just a quick follow-up on the LCD, more as it relates to iDose. So iDose wasn't specifically mentioned in the LCD, but it looks like, I mean, that they're asking for more, just more better data. Like, they want 24-month published data for a broad label. Can you tell us when Glaukos would have 24-month data published for iDose? And do you think the phase II-B data will be good enough to meet qualifications, or we need phase III data? And just lastly, like, it seems like with the eliminating the stacking, that would... I mean, would that mean a physician would not be able to do an iStent plus iDose and get covered for it? Thanks for the question.

Joe Gilliam (President and COO)

I'll start, and Tom may want to comment on this one as well. I think as it relates to iDose, first and foremost, it's not covered by this LCD. It's a pharmaceutical, as you know, and at this stage, is not within the purview of the LCD that was released by WPS. So I think that's a different conversation entirely, and so we have to take that into consideration there.

As you I think drew the line to sort of that broader that evidence, I guess what I would say is I'm not sure that we will have ever, if we're fortunate to get an approval as we expect, that we'll ever have launched a product that has more evidence behind it than iDose will at the time of the commercial launch. You've heard Tom reference on prior calls the sheer number of peer-reviewed publications that we expect to have, the totality of that evidence, the you know number of patients within it, as well as the long-term evidence that's contained within it.

You'll recall that we've already shown multi-year evidence in support of iDose out of our phase II studies, and ultimately, we'll expect to do the same over time out of our phase III studies. So I think the overall evidence there we feel stacks up pretty good against any request that may come from any payer, including the MACs.

Tom Burns (Chairman and CEO)

Yeah. I would just add, I mean, think about it. The phase II-B data we've carried out now, hopefully with some patients now out to 3 years, and those 3 years data, as we all know, show that 70% of those patients are controlled on the same or fewer meds versus the current standard of care from a topical standpoint, timolol, which was 46%. And so the data is profound, it's robust, and we believe that it will, in any discussions with any payers in the future, will serve us admirably to be able to receive fair and prompt payment.

Larry Biegelsen (Senior Analyst)

Great. That helps. And, and again, congrats on a nice quarter.

Joe Gilliam (President and COO)

Charles?

Operator (participant)

All right. Our next question comes from the line of Matthew O'Brien from Piper Sandler. Matthew, please go ahead.

Matthew O'Brien (Senior Research Analyst and Managing Director)

Hey, this is Phil on for Matt. Thanks for taking our questions. For starters, on glaucoma trends, specifically, what was it about August that led to that pronounced seasonality, and how is that seasonality trending in Q4? And as it relates to guidance, what's baked into that sequential step down in revenues? Is it more a function of working down that competitive inventory ahead of these LCDs taking effect, or is it really more a pausing in front of CMS' final rule?

Joe Gilliam (President and COO)

Yeah, I think... Well, first, in the context of the Q3, what we saw in August was perhaps a new normal in the context of seasonality, but it was a little bit of an aberration versus what we've seen in the last couple of years. I think it was more similar, quite frankly, to what we saw back in 2019 in terms of seasonality than what we've seen in 2020 through 2022. And it really was just a softening of demand. It was across all of our US procedures, glaucoma and corneal health in a pretty similar fashion. And in both those franchises were offset by strength in both July and September, strength that to your question, has continued in October.

When you think about how that translates into our, you know, 2023, you know, guidance, we try to take into consideration a variety of variables as we exit the year. I've commented on some of them. Clearly, we expect some potential short-term, you know, ordering pattern volatility and headwinds in December within our U.S. glaucoma franchise. That's both because of the potential final LCD effective dates, but also associated, as Tom mentioned in the prepared remarks, with the 2024 final CMS rule and the increased facility fee payments as you enter into 2024. We expect there could be a little bit of disruption as folks hold off on procedures at the end of the year to do them in the Q1, where they'll be paid a more fulsome payment.

We also expect some sequential FX headwinds based upon where that's been trending in our international glaucoma business. That could be a little bit of incremental headwind in the Q4. We may also experience some potential ordering disruptions at the end of the year around our U.S. corneal health business, as we're going to make a variety of moves there operationally this quarter in anticipation of a potential, you know, iDose launch in early 2024. Several of those operational things that we're going to be putting in place in this quarter can impact areas like customer service and our payer relation team priorities, they could create a little bit of disruption on the cornea side as well.

Matthew O'Brien (Senior Research Analyst and Managing Director)

That's helpful. And then just to give you one that doesn't focus on iDose, can you speak further about that agreement with Stuart Therapeutics and maybe the timeline for that ST-113 drug candidate?

Tom Burns (Chairman and CEO)

Yeah, I'd be happy to address that. So, Stuart Therapeutics has a very novel compound that's very—it's in a very nascent preparation, but we liked the data that we saw in some of the preclinical analysis. And what Stuart Therapeutics has, and what we hope to contemplate, is a bolus injection that could aid substantially in neural protection in glaucoma, which, as many of you know, is kind of the holy grail. Can you actually preserve the ganglion cells in the back of the eye, given the fact that it's repeatedly being assaulted by the pressure associated with glaucoma? So it is a novel compound, proprietary. It's very early. Like I like to say, terribly exciting, terribly early. Stuart Therapeutics, this is both. But again, it further validates the fact that we go first.

We're making an effort here to break ground in a whole new area of glaucoma treatment, and we're hopeful that this advances into a formal clinical trial.

Thanks so much.

Operator (participant)

All right, our next question comes from the line of Joanne Wuensch. Joanne, please go ahead.

Joanne Wuensch (Managing Director)

Thank you very much for taking the question, and congrats on the quarter. I'd like to talk about something a little bit less exciting, which is expenses. I did not hear an update, maybe on what you think your operating expenses could be. And then as you think about a product launch, this is the time of year that we start thinking about 2024. How do you sort of dovetail preparing and then launching everything that you've got in your pipeline, including iDose, not just this year, but next? Thank you.

Alex Thurman (CFO)

Hey, Joanne, this is Alex. I'll start with the operating expense question. So, I mean, first of all, we were pleased to see the operating expenses for the quarter come in as they did, just shy of $87 million, which was only up modestly, 1% sequentially. So we were happy with that. Again, as we've talked about in the past, we've been very, you know, focused on making initial adjustments to our pipeline in anticipation of iDose and, you know, basically trying to allocate our resources towards that as we prioritize our balance sheet and capital allocation.

You asked about the Q4, OpEx, and so basically what I would guide you to do at this point is we would expect a modest sequential increase in the Q4 to what we saw in this quarter, which is actually in line with what we've seen, in the past. Typically, from a, if you want to call it a seasonality standpoint, the Q4 tends to rise up a little higher than the Q3. That should put us, for total for the year, somewhere around what we had guided to, which was, a 10% or a little over 10% increase from last year, again, excluding all of the IPR&D charges.

Joe Gilliam (President and COO)

And then as it relates to, I think, the second part of your question, Joanne, which I'm not sure if that was more towards the expense side or the overall planning, but yeah, we're obviously, we've been in product launch planning mode for quite some time. We're now getting into the finer points of what that means from a expense perspective going into next year, how we balance that against other priorities. We do have a lot going on. Thankfully, we think there's a lot of opportunity with each of those.

And so, you know, we're going to be putting quite a bit behind iStent infinite as we enter into 2024, with hopefully more fulsome reimbursement coverage, and then ultimately iDose on the commercial side, while we continue to, you know, invest in our—what we think is a pretty full pipeline of rich opportunities.

Joanne Wuensch (Managing Director)

Just to push a bit, is a 10% increase annually in 2024 a reasonable starting point, or is it much higher than that, given everything else?

Alex Thurman (CFO)

I think we'll comment on that, Joanne, when we get to the next quarter's call, and we talk about our guidance in 2024 and what the operating expense profile would look like.

Joanne Wuensch (Managing Director)

That's fair. Thank you.

Alex Thurman (CFO)

Yep.

Operator (participant)

All right, our next call comes from the line of David Saxon from Needham. David, please go ahead.

David Saxon (Equity Research Analyst)

Great. Good afternoon, guys, and thanks for taking my questions. Maybe I'll start with a quick one on iDose. So you guys obviously completed the inspection and mid-cycle review in August. You mentioned a draft label, so, you know, when do you expect to receive that? And when you do, is that something you're going to share with the investment community? And then, aside from that, any other milestones to call out before December 22nd?

Tom Burns (Chairman and CEO)

Hey, David, I'm happy to answer that. So, we would expect to receive the draft labeling in the near term, let's call it the next several days. And that begins the process, and that process is, the FDA gives their best estimate of what they think the label should be based on the data that they're reviewing.... and then ordinarily and routinely, there is provision for response from the company to shape that label or if to contest it to the extent that they disagree with the, the FDA's position. So there'll be a period of, negotiation, which will occur prior to the PDUFA date and the final, we hope, favorable FDA clearance.

I think as you can probably expect, that that will be something that will be done privately and that we won't share prior to the PDUFA date targeted clearance.

Matthew O'Brien (Senior Research Analyst and Managing Director)

Okay. Got it. Thanks. And so I guess no other milestones after that. And then I'll just throw my second question in here. In the, you know, document you posted, it looks like you got a PreserFlo, PreserFlo study starting in the H1 of next year.

Tom Burns (Chairman and CEO)

Yeah.

Matthew O'Brien (Senior Research Analyst and Managing Director)

Does this address the concerns the FDA had raised, previously? And then you know, what's your estimate on timing to potential approval of that product? Thanks so much.

Tom Burns (Chairman and CEO)

Well, I'd be happy to address it as best I can. I mean, I put it as saying that we've taken a more, I believe, a novel approach in relooking at how we might evaluate the safety and efficacy of the PreserFlo device, given our substantial experience in the area. So we've had those discussions. We're finalizing an IDE with the FDA, and we are encouraged that we'll reach a conclusion, a successful conclusion, to opening up that study and beginning to study that product in the early part of next year, certainly within the H1. This will be a second bite of the apple, and I think with our informed kind of skill in the arts, we hope to be able to bring it to a successful conclusion.

I wouldn't comment on date. Too many things will enter into when we could potentially commercialize, such as rate of adoption and clinical enrollment, et cetera. But I will tell you that I feel very confident we'll be able to start that study in the H1 of next year.

Operator (participant)

All right, thank you. Our next question comes from the line of Allen Gong from J.P. Morgan. Allen, please go ahead.

Allen Gong (VP and Equity Research)

Hi, thanks for the question. I just had, you know, a quick one on the kind of iDose timing. You know, I understand you can, you can't really share the details of the mid-cycle review meeting, but, you know, you sound confident on the December time frame. And I guess, you know, I was wondering, relative to kind of your past interactions with the FDA, your past mid-cycle meetings, like, do you feel better or worse, or roughly in line? I'm just asking because we've, you know, we've seen some FDA approvals getting pushed out and delayed with, you know, reasons that are kind of not visible to us on this side of the table. So just curious if there's any insight you can provide on what gives you that kind of confidence.

Tom Burns (Chairman and CEO)

Yeah, I guess I'll be happy to give as best a reasonable assurance as I can. From everything that I'm aware of, given the mid-cycle review and searching for any potential impediments that might come up between now and the final conclusion, I feel pretty confident that we're gonna be able to move towards and we're tracking towards that date for the FDA review of December 22.

Allen Gong (VP and Equity Research)

Got it.

Tom Burns (Chairman and CEO)

Got it.

Allen Gong (VP and Equity Research)

And then just another question. You know, I understand that we don't want to talk about 2024 too much now, but when we just think about the growth of the MIGS market, kind of ex iDose, there's clearly been quite a few puts and takes over the last few years. You know, hopefully, 2024, you know, there's gonna be some bumpiness with the LCDs and the reimbursement changes. But how should we think about stable market growth going forward? Thank you.

Joe Gilliam (President and COO)

Yeah, Alan, I'm not sure that 2024 is perhaps the right measurement period, because we're obviously gonna be making our way through all the puts and takes associated with these shifts on the, you know, LCD front from the various MACs. I think we've certainly settled in that aside from maybe some of the moving parts there that we're talking about, you know, an underlying market that continues to grow in a healthy fashion as MIGS becomes increasingly the standard of care in combination cataract. Our expectation would be that from a macro standpoint, that starts to accelerate in the coming years again, as we drive our technologies, including iDose and iStent and iStent infinite, into a much larger patient population that's served by the interventional glaucoma approach in standalone patients.

So I think, you know, 2024 may be a period where some things settle out in the context of, of, what procedures are being done where, the net effect of which, as we said, we'll, we'll comment once we've got, you know, some additional work done on that front. But overall, I think that we're headed to a more favorable environment from a macro standpoint, because we're gonna be going after a much larger market.

Operator (participant)

All right, thank you. Our next question comes from the line of Steven Lichtman from Oppenheimer. Steven, please go ahead.

George Sellers (VP in Healthcare Research)

Hi, guys. This is Ron on for Steve from Grafen Recorder. I just wanted to ask another question on the LCD, and it was just a short one, hopefully, since everyone else has asked everything. Is, I know following the LCD, you can think about maybe as a net positive, since, you know, your competitors will probably lose much more business. Or do you guys see also a possible trade-off and as this LCD might shrink the market for MIGS in general? And how do you guys think about this, you know, new balance? Thanks.

Joe Gilliam (President and COO)

...Yeah, Ron, I mean, I think that's at the heart of some of what we were answering earlier, is the trade-off here that you have is how much the LCD itself or similar LCDs will restrict or constrain the market over the short term. Again, back to what I just said, I don't think over the long term it'll be as relevant as we're going, obviously, after a much larger patient population. But in the short term, the question is one of share relative to, you know, market growth and those dynamics as they shake out with all the various puts and takes in 2024.

You know, I think we're confident that ultimately this should be at least a neutral to slightly positive for our technologies because of the amount of evidence that's behind them, and that was validated as a part of this LCD. But it's very difficult at this stage to quantify that, particularly based upon, you know, a single LCD that's come out thus far in WPS.

Matthew O'Brien (Senior Research Analyst and Managing Director)

Okay. And just 1 follow-up, and I think nobody asked about this on iDose. You know, obviously, you guys can't market it yet, but will you be targeting or trying to promote it as an office-based procedure, or is that something that is not part of the plan?

Tom Burns (Chairman and CEO)

Yeah, Ron, I'm happy to address that. And so, as we've said from the beginning, I think just philosophically, we're agnostic, you know, to where the product, the site of service is and where it's used. But we do understand, and there will be some advantages to moving it into an in-office environment. And so what our supposition and proposal will be there is to work with societies, work with the MACs over the course of 2024 into 2025, to create kind of a relative workup scale of what a non-facility payment should be, and then get the MACs on board, to be able to reimburse at that level. And so this will be an ongoing process.

It is something that we'll be committed to over time, and we want to give surgeons the ability to have the alternative of doing the product within the ASC, which we expect will be the dominant use for some time into the in-office setting. And then I can assure you as well, that we continue to work on development programs that will continually aid our ability to move into that in-office facility.

Matthew O'Brien (Senior Research Analyst and Managing Director)

Okay. Thanks, guys.

Operator (participant)

All right, thank you. Our next question comes from the line of Anthony Petrone from Mizuho Group. Anthony, please go ahead.

Anthony Petrone (Managing Director Equity Research)

Thanks, great, and congrats on a good quarter and a good momentum. Maybe just 2 quick ones, 1 on iStent infinite, 1 on iDose. On iStent infinite, you mentioned in your prepared comments here on the quarter that you have a mild to moderate label expansion study going on, and so, you know, how large is that study? When will it be completed? When can we see data on that? And then quickly on iDose, when we think about label, what should we be thinking about in terms of just the duration of implant, right? So the pivotal study had a 3-month primary endpoint. You had a 12-month secondary endpoint, but the company, I believe, has data out to 5 years. So how should we be thinking about just the range of scenarios on duration of implant for iDose? Thanks.

Tom Burns (Chairman and CEO)

Okay, that's to answer the first part of the question, Anthony, and, and yes, we've begun the clinical study with the iStent infinite, and this was our calculus to move this product into the earlier intervention and treatment and to really supplement our whole interventional glaucoma philosophy and program. And so that protocol will consist of both phakic and pseudophakic patients that will fall under the descriptor of mild to moderate open-angle glaucoma. So we have a label now that positions iStent infinite for patients who've failed on medical and surgical prior therapy. This will allow us to open up the ability to use iStent infinite in the earliest phases of treatment for the treatment of glaucoma, and we think will be a nice, both supplemental and combinatorial alternative to the iDose device.

The second question, could you repeat that again?

Anthony Petrone (Managing Director Equity Research)

It would be on duration of implant and label for iDose. You have, you know, your primary study at a 3-month endpoint, you had a 12-month secondary endpoint, but I believe the company has referenced data on the implant out to 5 years, so there's a wide range of scenarios there. So just any high-level thinking on what the duration of the implant for iDose could be.

Tom Burns (Chairman and CEO)

Yes, let me address that again. Happy to. The. Remember, the primary efficacy endpoint and the, and the basis for our approval will be a 3-month determination of the iDose to show non-inferiority versus topical timolol. And you've seen the data, and I think we can all agree that we have a high degree of confidence that at least we'll have a reasonable argument to assure FDA approval in moving forward. There is no longer-term pivotal endpoint for the iDose device. What we've done prior to the FDA pivotal was to conduct this robust phase II data that we carried out to 3 years. That will be the basis for how we'll approach payers for how well this product works longer term, and I think we'll be assured that that data...

I think payers will be assured with that data, that the product does indeed provide substantive coverage for patients all the way out to 3 years. When you're talking about the 5-year data, remember, that was a cold set of patients from the phase II-B study that were exchanged. So 33 patients were we pulled from that, that reconsented to have an exchange of the, of the iDose device, and it was there that we came up with some pretty pristine data on endothelial cell loss to show that the exchange can be done with reasonable safety and security.

David Saxon (Equity Research Analyst)

Thank you.

Operator (participant)

All right, and our next question comes from the line of George Sellers from Stephens. George, please go ahead.

George Sellers (VP in Healthcare Research)

Hey, good afternoon, and thanks for taking the question. Maybe just 1 quick one for me, but could you just remind us, thinking back to 2022 and the end of 2021, how your market share of MIGS procedures in the U.S. shifted some reimbursement changes? And, do you have a sense for where that share went?

Joe Gilliam (President and COO)

Yeah, George, it's Joe. I mean, if you look back at our results in 2022 on our US glaucoma franchise, pretty consistently every quarter, we were down about 15% on a year-over-year basis. I think that gives you a pretty good sense of, at least in that, you know, time period, the share shift that occurred. Beyond that, it. Yeah, I don't have the data in front of me in terms of where that went, but I would say that the lion's share of that went to some combination of either canaloplasty procedures or goniotomy procedures, depending upon, you know, surgical preference.

George Sellers (VP in Healthcare Research)

Okay, great. Thanks for that color, and I'll, I'll leave it at just one. Thank you all for the time.

Tom Burns (Chairman and CEO)

Thanks, George.

Joe Gilliam (President and COO)

Thanks, George.

Operator (participant)

All right. At this time, there are no further questions. I'll turn it back over to the company.

Tom Burns (Chairman and CEO)

Okay, so I want to thank all of you again for your time and attention today, and we always thank you for your continued interest and support of Glaukos. With that, goodbye.

Operator (participant)

That does conclude today's call. Have a pleasant day.