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2024 Wells Fargo Healthcare Conference

Sep 4, 2024

Larry Biegelsen
Equity Research Analyst, Wells Fargo

I'm Larry Biegelsen, the med tech analyst at Wells Fargo, and it's my pleasure to host this session with the management team from Glaukos. With us, we have Joe Gilliam, the President and Chief Operating Officer, Alex Thurman, the CFO, and Chris Lewis, Vice President of Investor Relations. The format's a fireside chat. If anybody has a question, please raise your hand. We'll come around with the mic, or we'll just call on you. So gentlemen, thanks so much for being here.

Joe Gilliam
President and COO, Glaukos

Thanks for having us, Larry.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

All right. So, Joe, let's jump in here. You put together three quarters of solid growth, high teens here in the second quarter. Talk about where you are as a company today and how you see the next few years at Glaukos, please.

Joe Gilliam
President and COO, Glaukos

Yeah, I mean, I think it's been a journey to get here in terms of developing the earliest phases of the MIGS market and combination cataract surgery and all of the highs and lows of pioneering a new market category that we've gone through over the years. And we're really proud of that foundation that we've built and now obviously expanding that into rare disease and keratoconus as a part of the last couple of years. And I think we're finally at that inflection point that investors were so excited about, even back to when we were first going public back in 2015 , 2016 timeframe.

You know, this is about a much larger market opportunity for Glaukos, and you know, you're just starting to see, I think, the beginning of that with the performance you saw in the first and second quarter on a year-over-year basis. I mean, so much of this goes back to changing the standard of care towards more of an interventional glaucoma approach. And we're not alone in that, but we certainly are the leader of it. And we're just really starting to see the beginning of that, iStent infinite , you know, so far this year, and now the growing contribution of iDose and really going after much larger TAM.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Got it. That, that's helpful. So I guess let's talk about iDose.

Joe Gilliam
President and COO, Glaukos

Sure.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Um

Joe Gilliam
President and COO, Glaukos

Thanks for the warm-up question.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

So, you know, by our math, iDose sales were about $5 million in the first half of 2024. Joe, talk about how the launch has progressed thus far and how we should think about the ramp in the second half, please.

Joe Gilliam
President and COO, Glaukos

Sure. I think from a macro perspective, virtually all elements of the launch have gone according to, or a little bit better than we had originally planned, and we tried to lay out, I thought, very thoughtfully in the December approval call, and the questions that happened as a part of that. So if you think back to that, we talked about the early phases of the launch, which we saw at the end of first quarter, going into the second quarter, where you're providing access to those early surgeons who teach you as much as you teach them, to make sure that your sales force is well-educated and properly trained to go for that more broad launch.

And from there, you start to slowly expand that within your sales force in terms of the doctors that they're targeting, and they're starting to train, and they each have their own ways, and there's certain hierarchies within each of the territories in terms of where you launch first with doctors and then go from there. In parallel, so much of what we're doing is about also educating the practices on the reimbursement side and making sure that we're delivering the right onboarding experience for them so that they're, you know, executing on the J-code and the reimbursement associated with the procedural pharmaceutical like iDose appropriately. All of those things have really kind of have happened as we expected. You know, this really very much is the I call it the reimbursement confidence phase of the launch.

and as each individual practice gets experience with, in particular, the J-code, and seeing the payments come in, as they will, that enables them to move past the reimbursement confidence phase and much more into the clinical conversation. And that's where we get really excited about what that means, both for the short term, but certainly the long term for Glaukos.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Any surprises, good or bad?

Joe Gilliam
President and COO, Glaukos

Not really. I, you know, we've gotten that question a couple times, and, you know, you think about it. There's always little things in terms of, you know, you're always reminded how difficult these processes are in terms of launching a major new product, but nothing that's out of the ordinary versus what we've experienced in the past when we've done this. It's the day-to-day blocking and tackling and execution that really matters, and we've been all over that. So nothing really that I would call out as a surprise.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Okay. And on the Q2 call, you pointed to the street to kind of flatter sequential iDose sales in Q3. I guess the question people are asking is, you know, why wouldn't growth continue to accelerate or ramp?

Joe Gilliam
President and COO, Glaukos

Well, you know, at the time of the call, what we were referencing is the fact that you have a bit of a reset moment to the J-code. So you obviously go out, you're getting that initial adoption associated with the miscellaneous code and those practices that are comfortable going through that process, of which not all are. But in many ways, when you get to the J-code, there's a reset moment there, where each of these practices wanna make sure that they've done that appropriately, that the MACs are, in this case, paying appropriately, that they're getting those claims adjudicated.

The only comment we really made in the context of the third quarter, which is obviously a very narrow point in time versus the overall launch, is that you didn't know exactly when would, you know, those claims be processed, adjudicated, enough come back in, such that the account or the administration of the account says, "Okay, we're comfortable that if you're doing it the right way, we will indeed get paid," which they will. And that you can start having that clinical conversation and start scheduling those patients for those procedures. So there's a, you know, trajectory that we're on, and you just didn't know how much of that will accrue in the third quarter versus the fourth, versus obviously, as we move into 2025.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Are physicians starting to get reimbursed by CMS, and how long is that taking?

Joe Gilliam
President and COO, Glaukos

The answer is yes, and it's, but it's variable in timing. I think the quickest that we've seen is less than 15 days, which is, what if you look at a broad book of business with dealing with Medicare, it's not uncommon for procedures to get paid as quickly as, you know, 10 to 15 days. I think the general averages people talk about are more like 20 to 25 days for reimbursement. We're seeing a variety of those things, including some that are still, you know, in process that you know we work closely with the MAC and the practices do themselves to make sure they're being adjudicated. But it's really just the processes and internal workings of the MACs at this point and getting those things smoothed out.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Once a lot of physicians we've talked to said, "Well, we'll do one, we'll do a couple

Joe Gilliam
President and COO, Glaukos

Yeah

Larry Biegelsen
Equity Research Analyst, Wells Fargo

patients, a couple eyes, wait to see if we get paid." Now that they're getting paid, I would imagine it opens to pick it up faster and more.

Joe Gilliam
President and COO, Glaukos

Yeah.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Is that fair?

Joe Gilliam
President and COO, Glaukos

Yeah, and that's really the point of what I was saying before, is that, you know, in the context of any one period of time, any month, any week, any quarter, it's a question of exactly how quickly that, what you're describing translates into the, that behavior in those procedures. But that is how it works. There's a governor in the context of the practice administration that says, "I wanna make sure that this is gonna work the way Glaukos says it's gonna work." And once they see that, then they can have a clinical conversation around, "Okay, where do we wanna take this, and how are we gonna continue the adoption curve and schedule those additional procedures?" And that is what we're seeing.

Every day, we see more and more of those practices getting past again the reimbursement confidence phase and into the clinical adoption phase.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

While we're on reimbursement, the physician fee, are you seeing any consistency there and any numbers you can share?

Joe Gilliam
President and COO, Glaukos

You know, we saw the first professional fee schedule posted in the Noridian region. They have multiple jurisdictions. That ranges from the six hundreds to the mid eight hundreds, I believe, at the high end.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Hundred.

Joe Gilliam
President and COO, Glaukos

And, the sweet spot, most of the jurisdictions being in the $700 range, $750 range. That puts it right square with where most glaucoma procedures are reimbursed today. And obviously, there's a broader glaucoma, you know, procedure reimbursement range of $600 to $1,000-ish, depending upon the procedure. And so that's squarely in there. And the professional fee payments, while sporadic in other, you know, regions ahead of an actual schedule, have been aligned with that as well. So I think so far, and it's the early days in the professional fee, they tend to be lining up with the broader, you know, glaucoma procedure precedents.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

So that's good. I mean

Joe Gilliam
President and COO, Glaukos

It is

Larry Biegelsen
Equity Research Analyst, Wells Fargo

you're asking for at least five hundred and

Joe Gilliam
President and COO, Glaukos

Yeah, and I think there's always, you know, over the long-term with success and volumes comes, you know, incremental risk to that, and we've said that before. But I think the fair place for these procedures to be are aligned with the broader group of glaucoma procedures that are standalone, out there.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

You expect the other MACs to post something similar to what Noridian posted?

Joe Gilliam
President and COO, Glaukos

It's hard to say. I mean, I think we're still in the early days of that. You know, in fact, the fact that Noridian has even posted a fee schedule at this stage is a positive. I mean, what if you dial back to what we said previously, we sort of expected that to be activities that happened more as we turn the page into 2025, that these folks would start posting the fee schedule. So there's still, I think, some wood to chop there before I can say, you know, that definitively, Larry, but so far, so good on that front.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

And then surgeon training. How do we think about surgeon training, the ramp? It sounds like you, your commentary on the recent call suggests it could be faster than the iStent ramp, which we have numbers for.

Joe Gilliam
President and COO, Glaukos

Yeah. Well, you know, if you look back historically, we were able to train somewhere between six and eight hundred docs a year, as we were really launching combination cataract MIGS with iStent and then the inject. And a lot of that's gated just about scheduling time and your ability to get to these practices and how you can do that in the OR. But I think for us, in the context of iDose, it's amongst the most straightforward in terms of the learning curve. The heavy lifting for the average surgeon ophthalmology was the angle-based, getting comfortable with angle-based procedures. As they've gotten more and more of that, whether it's our technologies or others, adopting something like iDose becomes a pretty straightforward exercise.

And so I don't know that the training element is gonna be the most significant gating item for us in terms of, you know, how we ramp from here. I think it has a lot more to do with getting past reimbursement confidence phase, expanding patient access in terms of commercial carrier coverage, Medicare Advantage coverage, and the like, as well as then having the clinical conversation around the target patient population and getting docs more and more on board with the sort of interventional glaucoma mindset.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

So what is the status of expanding coverage? You know, when do you expect? Right now, it's basically that Medicare fee-for-service patient that has supplemental coverage, that's the sweet spot. Is that where you're seeing most of the utilization? And where do you see expansion next?

Joe Gilliam
President and COO, Glaukos

Yeah. Most, if not all, the utilization is there today, and that's by design and the way we're talking to these accounts from an onboarding perspective. It's not uncommon that you do that, but from our standpoint, the vast majority of the Medicare fee-for-service patients have supplemental coverage that takes care of most, if not all of their, you know, out-of-pocket expenses associated with these procedures. So that part is where we're at. Now, having said that, behind the scenes, commercial coverage and Medicare Advantage, and even some Medicaid policies are already in place. So our team on the payer relations side has been hard at work since actually, you know, through the approval and in the earliest phases.

So a lot of those policies are already in place, but we wanna launch that at a point where there's enough critical mass that it makes sense to do so, and we have to make sure that we really get the accounts themselves good at that part of the process. It's obviously far more complex dealing with prior authorizations and benefit verifications and the like, and ultimately adjudicating a claim through the commercial carriers and the contracting, et cetera, is much more complicated. So it's something I would expect to see from us as we make our way through 2025. It's ultimately an important, you know, part of the opportunity for iDose and for those patients that are there.

You know, as we kind of make our way into 2025 , you expect to see us really turn that on.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Are you gonna be able to provide metrics like covered lives or anything like that? How are you gonna communicate kind of the coverage

Joe Gilliam
President and COO, Glaukos

Yeah

Larry Biegelsen
Equity Research Analyst, Wells Fargo

of iDose to the investment community?

Joe Gilliam
President and COO, Glaukos

Yeah, I think when we're ready to actually start having that as a part of our launch dynamic, and that we're out there doing that, being able to describe the covered lives is pretty typical. So I think in some of the competitive products, they talk about 95% coverage. Obviously, that comes with different types of policies that are very relevant in that. But I could see us talking about, you know, the percentage of covered lives in a similar fashion.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

What other metrics are you gonna share with us?

Joe Gilliam
President and COO, Glaukos

As a part of iDose? Well, stay tuned on that. I think, Larry, I mean, we've been fairly transparent that, you know, our number one goal is to let our overall growth speak for itself. And while we understand trying to provide enough detail that, you know, allows folks to understand the components of that growth and ultimately extrapolate that over a longer period of time going forward, I don't know that we feel compelled to get overly granular, certainly at a level that would probably make you happy, when it comes to the iDose launch.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

So we're gonna have to keep guessing the sales on the earnings calls? Whoever gets closest, you'll say, "You're hot or cold?

Joe Gilliam
President and COO, Glaukos

I'm not even sure I'll say if you're hot or cold, but, but again, I think I'll point you back to the overall performance, which you alluded to before. Obviously, an accelerating growth profile overall for the company, but certainly within the U.S. glaucoma franchise, and I hope to see that continue to grow from there.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Maybe talk about the patient selection. Any updates there on the types of patients? You know, we did a survey, we saw it said it suggested that doctors would use it more in combo cataract cases. I'm actually hearing that anecdotally. You know, I know you've said our focus is standalone, our focus is standalone, but what are you really what are you actually seeing?

Joe Gilliam
President and COO, Glaukos

Yeah, so that's interesting that your surveys have said. It's probably in terms of the way they think, and depending upon the surgeon mix of who you're talking to, where it's easiest for them to adopt it. Clearly, if you're a high-volume cataract surgeon, and that's your workflow today, deploying iDose within that, you know, treatment paradigm is the most straightforward thing for you to do. But having said that, to date, the vast, vast majority of the procedures have been standalone. So a small fraction have been combination cataract and/or combination with some other glaucoma procedure. That doesn't mean that they, you know, we're allowing that to happen, but we are asking to keep it as simple as possible and standalone, you know, without other, you know, influencing factors, keeps it as simple as possible when you're trying to get the coverage established the right way with the MAC.

But, I certainly expect, and we certainly expect that utilization of iDose to treat glaucoma is irrespective of whether they're doing a cataract surgery or not. It's just that from our standpoint, the opportunity to do what's right for these patients is so much larger in that standalone interventional arena than combination cataract, but that doesn't mean that we don't expect it. Quite frankly, in the early days, you may see a fair amount of utilization there, but we won't stop in terms of trying to build the overall market and change the standard of care towards this interventional glaucoma mindset.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Joe, everybody's trying to figure out the ramp. Obviously, you know that. People look at analogs. Two analogs, one is iStent, and one is Durysta. We have good numbers on iStent and decent numbers, some numbers on Durysta.

Joe Gilliam
President and COO, Glaukos

Yeah.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

What advice would you give investors who are trying to figure out how to think about the ramp and the best analogs here, you know?

Joe Gilliam
President and COO, Glaukos

I certainly think using those two iStent's probably the more relevant analog in terms of, you know, unfolding the combination of the market access, plus the education and training of surgeons. What was unique about the Durysta launch is they did so with an existing Category I code . It was in-office as a procedure, and so, from that standpoint, I think they had a fairly rapid initial uptake that then sort of moderated, you know, if you looked out twelve or twenty-four months from there, from a growth profile standpoint. I certainly hope that our launch looks a lot more like the trajectory that we saw for the first, you know, six, seven, eight years of the stent franchise in combination with cataract surgery.

In terms of the adoption curve, obviously, we're going after a much larger, you know, patient population with the label associated with iDose.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

When you talk about just to make sure we're talking apples to apples or, you know, we're on the same page. iStent, we have the actual procedure numbers. When you say that's the analog, that would be a better analog than Durysta, is it the actual iStent numbers, procedure numbers, that you're referring to?

Joe Gilliam
President and COO, Glaukos

No.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Or

Joe Gilliam
President and COO, Glaukos

No, it's apples and oranges. I don't think you can do that. I think you have to look at

Larry Biegelsen
Equity Research Analyst, Wells Fargo

The penetration

Joe Gilliam
President and COO, Glaukos

the actual penetration and you have to be thoughtful about the way you segment the marketplace. So obviously, there's an awful lot of eyes out there. 21 million at last count that have high pressure or glaucoma, 12-13 million of which are diagnosed, roughly 10 million are actively treated. And so when we do the modeling exercise internally at Glaukos, we break that down into the constituent parts and say, how rapidly can we penetrate into each one of these? You can look at it from a payer coverage standpoint, which you need to, and you can also look at it from a clinical standpoint. How many of those patients have already entered the journey of interventional glaucoma? How many are getting SLTs? How many have gotten Durystas?

How many have, you know, potentially memory issues or mobility issues that prevent them from doing it? How many have severe dry eye? How many have severe hyperemia? Different things that make the adoption curve that much more straightforward, versus, I'll call it, the one that will take longer, which is a healthy, you know, high pressure eye that hasn't shown glaucomatous damage, that hasn't had a cataract surgery done yet, that ultimately will probably get treated in an interventional manner, but doctors will get there last, relative to some of the lower-hanging fruit that's out there.

So when you're looking at that, you know, five and 10-year adoption curve, you have to really. I think the stent business shows the trajectory in which you can educate and train, you know, physicians in our space, and apply that to all these different subsegments of the patient population that exists within that much larger TAM.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

All right. Well, we'll take that offline because,

Joe Gilliam
President and COO, Glaukos

You want me to do your model for you, Larry? I can't. That's a step too far.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

iDose TR for the office setting.

Joe Gilliam
President and COO, Glaukos

Yeah.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

What are the milestones between now? And I think you've said by the end of 2025 or

Joe Gilliam
President and COO, Glaukos

Sorry.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

You should have approval, or what? Remind us of, like, the pathway.

Joe Gilliam
President and COO, Glaukos

Yeah, I think Tom made that comment-

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Yeah

Joe Gilliam
President and COO, Glaukos

- on the last quarter or two earnings call.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

That's our target.

Joe Gilliam
President and COO, Glaukos

That was, you know, referencing late 2025 as kind of the timing for that. It's a combination of turning on the reimbursement codes for in-office, combined with getting the FDA approvals for that injector system that is associated with the in-office iDose procedure. But the business end of the iDose in that, just to be clear, it's still iDose TR. It's just an injector system that makes it that much more in-office friendly, if you will.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Okay. And how important do you think that is?

Joe Gilliam
President and COO, Glaukos

Over the long term? Very important. I think, you know, our goal has been to meet the surgeon and the patient wherever, you know, they prefer from a site of service, whether that's in a hospital setting, an ASC setting, or an in-office setting. We want to make sure and enable, you know, iDose as a part of that.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Mm-hmm.

Joe Gilliam
President and COO, Glaukos

You'll talk to different doctors and get very different answers on that. You'll talk to doctors today who do a lot in the ASC, but would like to do more in the office with a minor suite, if they've got it. I think there's elements of the ophthalmology industry that are moving this direction. They have been for a while. Some earlier adopters and some, you know, late adopters, and we want to make sure that we're enabling, you know, those surgeons to do the procedure wherever they deem fit.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Got it.

Joe Gilliam
President and COO, Glaukos

But I think it's important. I think it'll be. You know, if you look out five and ten years from now, the ability to do these procedures in your office certainly opens up access to a lot of patients.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

All right. I mean, we didn't talk about Infinite, but what kind of impact has the focus on iDose had on the adoption of Infinite?

Joe Gilliam
President and COO, Glaukos

Yeah. It's one of the things that we're watching closely. I mean, obviously, from a investment of time perspective, if you're just looking at, you know, kind of, the ROI on a minute of sales force's time, you can imagine that there's an awful lot of focus and incentivization around iDose and driving that going forward. Having said that, Infinite is such an important product for those patients, and the ability to get something as benign as, you know, an iStent, in the case of iStent infinite , for those patients who are progressing to potentially a much more invasive procedure. I think we have a moral imperative to drive it as far and as fast as we can.

But I'm practical that, you know, as the sales force continues to lean in on the iDose opportunity, you know, that could come at the expense of, you know, moderating some of the growth that we've seen, certainly in the first half of the year with iStent infinite . And that's just something that we'll have to continue to monitor and dial in, in terms of how we're focused on that. But, you know, if there was no iDose, I have a lot of confidence that iStent infinite , the growth we're seeing, would be something that would continue for the foreseeable future because the opportunity there is quite large, too. But I could see some impact from just time management associated with iDose.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

And any concern of that same dynamic happening with the iStent franchise because of the focus on iDose?

Joe Gilliam
President and COO, Glaukos

I just think in general, I would caution investors from getting too aggressive on both sides. So, you know, sometimes you can look at a model in a two-dimensional way, or a one-dimensional way, and I think you have to think about that time and mental allocation of time and effort for the sales force. And I think all the success that is expected and we hope for with iDose may certainly come at a bit of a cost to the overall potential growth of that stent franchise. Now, you can also say on the opposite side, you know, the portfolio and being, you know, so relevant in these accounts and helping drive the broader interventional glaucoma movement may benefit, and that's what we're gonna see.

You know, how much of this... You know, does the growth happen because you're changing the standard of care more broadly versus the, you know, allocation of time and any headwinds that come from that for the sales force?

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Okay. When we think about twenty-five, just maybe broad strokes on some of the puts and takes.

Joe Gilliam
President and COO, Glaukos

Staying within the U.S. glaucoma franchise first, and then I'll get to the other areas of the business. Clearly, the biggest growth driver is gonna be the continued expansion and access to iDose. We all know that. I look forward to being, you know, past the reimbursement confidence phase to where you're really starting to drive the early clinical adoption phase of iDose to me, that means the patients that are already resident within that practice. They're already being treated in that practice and, hopefully, in some cases or many cases, on an SLT therapy or drops or whatever it might be, and really starting to drive adoption there, and then ultimately starting to shift and do the groundwork for that much bigger opportunity in terms of the whole ecosystem within it.

Turning on the commercial coverage, and the Medicare Advantage coverage over the course of the year, incremental driver on that, as well. And so, and I think as we turn on to, you know, the international side of glaucoma, you know, that really is about new product approvals. Obviously, the path to market in Europe, in particular, has been elongated in recent years with the MDR, you know, regulations and that are there. We've been in that process for some time, so, you know, I'm hopeful that any day now, we can start to see a couple of the products get approved there. Not iDose. That's different. It's on a different path, way, that's a little longer term for these international markets.

But for the iStent infinite and some of the other product portfolio to really round out what has been in those markets for a while with inject and inject W, I think will be an important growth driver, and PRESERFLO in certain markets where we've got that as well. And then lastly, on the corneal health side, you know, I expect and I think we expect that the growth trajectory there will stay somewhat muted between now and ultimately getting Epioxa approved. And the reason for that is largely our decision to enter into Medicaid Drug Rebate Program, so the MDRP.

It comes with an opportunity in terms of patient access on the iDose side, but it certainly costs us in terms of the rebates and some of the things that are associated with the Photrexa business that when we report the revenues there, our headwind we've already been experiencing, and we would expect to see more of between now and the launch of Epioxa.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

So consensus 462, 24% year-over-year growth next year. Any reaction, Alex?

Alex Thurman
CFO, Glaukos

You couldn't go to me.

Chris Lewis
VP of Investor Relations, Glaukos

I'm going to take Joe's answer, which is

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Joe.

Chris Lewis
VP of Investor Relations, Glaukos

No comment at this time.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Chris, maybe any

Joe Gilliam
President and COO, Glaukos

No, I wouldn't comment on that. We'll give guidance when we give it, but, you know, I think we have a lot of reasons for optimism over, you know, the planning period, and we're just focused on execution.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

The iDose numbers, you made a comment earlier about not getting too, I don't know, carried away on both sides, if you will. The iDose numbers this year are consensus $23 million. Next year, call it $98 million. Chris, I don't. Correct me if I'm wrong. You know, do you think people are properly calibrated, or are people missing something?

Joe Gilliam
President and COO, Glaukos

I don't know that we've done all that much to help or hurt the calibration of that, and I'm not sure we would hear either. I think there's a lot of opportunity resident with this, you know, individual glaucoma movement, and iDose is a part of that, and I think we'll continue to dial that in for investors as we move forward here. But I just-- I'm not sure, you know, that I appreciate the fact that you all have a tough job, and you are doing that work to establish the, you know, initial targets for your models. You have to. But we probably haven't given you all that much to go from yet, and I'm not going to comment on it.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Just taking a step back, you did talk about sequentially flat in Q3 versus Q2, and I think you did talk about. I don't remember the word.

Joe Gilliam
President and COO, Glaukos

Yeah

Larry Biegelsen
Equity Research Analyst, Wells Fargo

as inflection, but, you know, Q4-

Joe Gilliam
President and COO, Glaukos

Well, we would expect the momentum to start. I mean, again, it comes back to shifting from reimbursement to clinical. And we expect that as we make our way through Q3, and we go into Q4, and certainly into 2025, that the conversation becomes much more about clinical, in which case there's a much larger market opportunity that we're going after. And I think there's many different ways to get to numbers that I think are attractive in the context of the growth profile of Glaukos. And you know, we feel confident about where we're headed with that product. I'm just not going to get so specific on an individual number.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Got it, and profitability, Alex?

Alex Thurman
CFO, Glaukos

Yeah, the way I'd answer that, Larry, is if you think about our history, pre-COVID, we always lived within our means and you know, generated cash enough to run this business and invest in our pipeline. And then we entered into a period of investment, really around getting ready for iDose. We had to build a facility. We had to get just everything development-wise ready, and now we're on the other side of that, right? So to your point, I mean, our initial near-term goal is going to be to get back to living within our means, right? Get to cash flow breakeven, get to cash flow generation.

But as you know, we have a large and rich pipeline that still needs to be funded, and so profitability, that goal, is probably out more in the mid- to longer-term vision, as we fund those projects, and which we think are very valuable to investors in the long term.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

I mean, I, I think the Street's modeling operating income positive for Glaukos in 2027 or so. Is that consistent with what you just said?

Alex Thurman
CFO, Glaukos

It could be. It just depends, you know, a lot of things, and the other thing I'll say, Larry, is with iDose and the success of what we hope to see with iDose, it's very possible you'll see quarters of profitability, where we're not able to reinvest the funds generated by iDose fast enough, but as we've spoken to, as you know, there's a lot of great things that we can invest in the pipeline that should add value in the long term.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Okay. And, Joe, you talked about Epioxa. You're supposed to, my understanding is you're going to file by the end of 2024 ?

Joe Gilliam
President and COO, Glaukos

That's correct.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

When are we going to see the data?

Joe Gilliam
President and COO, Glaukos

I don't know that we've actually said that other than

Alex Thurman
CFO, Glaukos

Before then.

Joe Gilliam
President and COO, Glaukos

Yeah, before then, we'll do that. We haven't decided on exactly when, where, or how we'll do that, but certainly before the end of the year.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

You've released a lot of data at JPMorgan in January. Sounds like, Chris, you think we'll see this data before the end of the year?

Chris Lewis
VP of Investor Relations, Glaukos

I think that's our expectation.

Joe Gilliam
President and COO, Glaukos

Yeah. But I mean, there's multiple ways you do that in terms of top line versus a little bit more and all that. So we're in the process right now of evaluating the optimal, I'll call it, re-release of that.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

I mean, the FDA asked you to do a second trial.

Joe Gilliam
President and COO, Glaukos

Yeah, which is common in ophthalmology to do, those two. And yes, so we have, you've already seen the first trial.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Right.

Joe Gilliam
President and COO, Glaukos

And so it'd really be the second trial and kind of putting those two together.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

So you feel good about where you are right now?

Joe Gilliam
President and COO, Glaukos

I think I'll wait to break news when we break news around that. I think we're heavily focused on preparing for what will be another major product launch for us, you know, late next year.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Okay. Anything we didn't cover?

Joe Gilliam
President and COO, Glaukos

That was pretty comprehensive. I mean, I think that probably the one thing we didn't cover as much was the development progress we're making on the retinal side of the franchise as well. You know, understanding where we're at as a company, I certainly appreciate the focus on iDose, and it's rightfully placed. But you know, we're now in first in human studies on a pretty transformational program in retinal disease. So you know, we're excited about that. We're making progress there from a clinical trial perspective, and hope that's another thing that we can share, as we kinda turn the page on twenty-five and we're or twenty-four, and we're entering in 2025 , that we can provide more color and context around the opportunity associated with that important program.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Anything on repeat dosing? Any updates for iDose?

Joe Gilliam
President and COO, Glaukos

No, you know, as I think Tom said on our last earnings call, that is a, you know, a dossier submission package that, quite frankly, contains things that the FDA's already seen, but that was going into the FDA with meetings to be scheduled thereafter. And so, you know, I think that's a part of that engagement. You know, based upon what we do and don't hear as a part of that engagement, that will craft either, you know, label adjustments and/or incremental study, you know, designs that we'll have to decide whether that's a part of iDose TR or whether we incorporate that into iDose TREX and that study that's there. There's a lot of moving parts on that that we'll try to bring together here in the relatively near future, based upon the dialogue with the FDA.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Publications, iDose publications, are we waiting for any new ones?

Joe Gilliam
President and COO, Glaukos

How many are we up to now, Chris?

Chris Lewis
VP of Investor Relations, Glaukos

I think we have six or seven now, and there will be you know, we'll continue to grow that here over the coming months and years.

Joe Gilliam
President and COO, Glaukos

Yeah.

Chris Lewis
VP of Investor Relations, Glaukos

I think there's more to come.

Joe Gilliam
President and COO, Glaukos

I think we've seen, I don't know, there's 10 or 12, at least, that are overall plan, so.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

I know you're headed to Europe after later this week.

Joe Gilliam
President and COO, Glaukos

Yeah.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

Is there an opportunity for iDose outside the US?

Joe Gilliam
President and COO, Glaukos

Ultimately, yes. The timing and it varies market by market. I think you have to be cognizant of the global reimbursement landscape whenever you're thinking about a pharmaceutical launch outside the U.S. So we're in the process of assessing both the regulatory and market access landscapes in each of the individual markets, and then overlaying that with our timeline and strategy, especially with iDose TREX and the launch here. So, more to come on that. I think that's a little ways out in terms of a potential growth driver for us, but certainly something that we're deep in consideration on.

Larry Biegelsen
Equity Research Analyst, Wells Fargo

All right. Questions in the audience before we end? Cool, well, we will end it there. Thanks so much.

Joe Gilliam
President and COO, Glaukos

All right. Thanks, Larry.

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