Glaukos Corporation (GKOS) Earnings Call Transcript & Summary

March 1, 2023

New York Stock Exchange US Health Care Health Care Equipment and Supplies conference_presentation 37 min

Earnings Call Speaker Segments

Joanne Wuensch

analyst
#1

Well, welcome back after lunch. I'm still Joanne Wuensch, the medical technology analyst here. That has not changed. But these people are new up here. So let me introduce Joe Gilliam, the President and Chief Operating Officer; Alex Thurman, CFO; and Chris Lewis, Vice President, Investor Relations and Corporate Affairs, and they're from Glaukos, in case you don't know.

Joanne Wuensch

analyst
#2

So's a lot to talk about, but I think I'm going to go straight to the chase, which is guidance. I'm seeing a lot of pushback on how you decided to put guidance together. So let's start there, how you think about kicking -- building off of the fourth quarter '22 delivery. What the puts and takes were in as you thought about 2023?

Joseph Gilliam

executive
#3

Sure. Well, no warm-up question, I guess.

Joanne Wuensch

analyst
#4

No I'll ask again [indiscernible].

Joseph Gilliam

executive
#5

That's fair. So I think a handful of things, and it's probably best to break it down in the conversation around the individual business areas as you think about the 2023 guidance. But from a macro standpoint, first, our thinking really was, coming out of 2022 in the CMS related headwinds and things were there, we really want to make sure that we were kind of walking before we ran. There's a lot of reasons to be optimistic from various potential drivers of revenue in 2023. But in general, we wanted to sort of see some of those proof points play themselves out a bit before we got ahead of that from a guidance standpoint. As it relates to the individual areas of our business, I'll start perhaps in the Corneal Health segment, where if you look over the last several quarters, certainly the last year, 1.5 years, we've established a pattern of sort of high single-digit to low double-digit growth. And I think that we feel confident about the ability to continue to deliver that high single-digit type growth in that franchise over the course of the year. The biggest drivers there tend to be the continued adoption of Photrexa in the United States. And we've put a lot of investments to continue to accelerate that. But we're also enhancing some of our other services around it, including co-pay assistance, things like that, that tend to be a gross to net adjustment. And so we may see a little bit of that headwind against the -- what otherwise would be the trend entering the year. On the international glaucoma side, if you look back over the last several quarters on that, we've pretty consistently, at least in local currency, FX has been on quite a journey over the last 12 to 18 months. But on a local currency perspective, we've delivered 20%, 25% growth there and feel good about it. I think it's still early days in those markets. But having said that, entering the year, I think now at this point, Alcon has owned Hydrus, for example, for a year, and they're obviously well established internationally, and we expect to continue to see them entering in those markets, and we want to make sure we are being prudent around those dynamics as we think about the full year 2023. And that leaves the U.S. And I think there, it's really continued trends around the CMS dynamic, which I'm sure you'll want to explore a little bit more and the sunsetting of some of those things as we enter in 2023, hopefully being offset by some of the growth drivers we have, whether that be iAccess, iPRIME or perhaps most importantly, iStent infinite in 2023.

Joanne Wuensch

analyst
#6

So let's start with the U.S. market. And reimbursement changed significantly, which impacted sales last year. How did it also maybe impact physician practice?

Joseph Gilliam

executive
#7

Yes. Well, I think they're in some ways the same. I think that any time you have that magnitude of change from a reimbursement standpoint that we saw, there's going to be some shifts in the way that patients -- surgeons think about their treatment algorithm. And in this case, we've certainly seen that over the course of the year that was reflected in our results. Thankfully, it wasn't the magnitude that we feared. And that, candidly, we felt pretty good about the way that most surgeons continue to view the risk-benefit calculus of doing stents in combination with cataract surgery versus other perhaps more invasive alternatives.

Joanne Wuensch

analyst
#8

Do they start using other types of procedures to deal with glaucoma or maybe even stay on drops longer?

Joseph Gilliam

executive
#9

No, I think what you've seen, it's less about that broader paradigm shift where it's about drops versus that. Maybe there's some of that. But I think it has more to do with the shift towards a bit more invasive procedures of goniotomies and viscodilation of canaloplasty procedures. And that's what we saw really almost day 1 of 2022 when those CMS adjustments came into place.

Joanne Wuensch

analyst
#10

So why the more conservative is my word look towards the 2023 U.S. guidance, this is behind you, you've annualized it. Somebody even call it easy comps.

Joseph Gilliam

executive
#11

Yes. Yes. It's always easy when it's a spreadsheet, right? I think the reality is that any time you come out of a stretch like that, where as an organization, really most importantly as a sales organization you're [ planning a lot of defense ], right? You're having conversations around economics, which is not necessarily their happy place. They'd much rather be talking about the risk benefit calculus or the clinical utility of the product. And so as you turn the quarter in this year, there's no doubt we're hopeful to be much more on the front foot. It's true. We've sunset obviously, the direct impact. But those selling efforts don't go away, right? I mean the conversations with the surgeons don't go away. You just hope that there's a dwindling impact of that. And I think we saw that over the course of 2022, it gives a reason for encouragement '23, but I think we'd rather see a little bit more of it play out before we start getting more refined on kind of what that means to that specific number for '23.

Joanne Wuensch

analyst
#12

Do you think during this transition period, the market slowed significantly? And what do you think happened to your share?

Joseph Gilliam

executive
#13

Yes. I think anytime you have that conversation in a dynamic like what's going on with the CMS cuts in the U.S., you have to break that down between volume and dollars, right? And I think on the volume side, certainly coming out of COVID, I have every reason to believe that the market continue to grow or grow fairly nicely over the course of the year and probably still doing so as we enter into next -- into 2023. From a dollar standpoint, there probably was a bit of a -- actually a material headwind as you think about that conversion from stent-based procedures to a portion of them being done either in canaloplasty or goniotomy, which tend to come at a little lower price point. So I think that was a dollar headwind to the market. Similar to our own business, I think you lapped that heading into 2023. And I think the dynamics from a market standpoint should be accelerating as you think about the combination of factors and one, getting that seismic move behind you, the continued move towards doing multiple procedures where -- depending upon the disease progression in that patient, surgical preference leaning in that direction. And then ultimately and most importantly, the move out of combination cataract and into the broader stand-alone interventional glaucoma market, which have, quite frankly, dwarfs that opportunity at the combo cataract.

Joanne Wuensch

analyst
#14

Little bit on the macroeconomic side, patients need to pay co-pay, elderly wanting to pay out of pocket for certain things or not depending on how their retirement portfolios have been doing. What are you seeing in those factors?

Joseph Gilliam

executive
#15

I think it's a great question. That the Corneal Health side of the franchise is probably more exposed to that dynamic as you described, because the vast majority of those patients are covered by commercial insurance. In the case of the glaucoma franchise, certainly in the U.S., as you know from past conversations, about 80% of those are done by Medicare patients, and a lot of those patients have secondary insurance and the like associated with our Part B coverage. So I think it tends to be more immune to that in the glaucoma side, not totally, but more immune on the cornea side. We haven't seen a lot of that, but in some ways, our own move to try to make sure we have enhanced co-pay assistance programs. It's designed to alleviate some of that potential economic burden for the patient in that setting.

Joanne Wuensch

analyst
#16

And what about for the physician who may want to add or subtract certain MIGS procedures into his or her practice. I mean there's an upcharge or a stacking or what pick the adjectives that may or may not happen as they start to do that?

Joseph Gilliam

executive
#17

Well, I think for the surgeons that -- for the most part, practices remain quite healthy at this stage. And so if anything, when you have your channel checks, you'll hear more about backlog building than you will about procedural demand being an issue and some of that's COVID, but a lot has to staffing, which I think has probably been exhausted as a topic at this point, but it's still a reality whether it's in their billing and reimbursement folks or whether that's in the technical staff associated with the procedures, it's a real consideration. So most of the docs that we talk to in the accounts, their patterns are full.

Joanne Wuensch

analyst
#18

Okay. Being a student of ophthalmology for a long time, recession-resistant, recession proof?

Joseph Gilliam

executive
#19

Well, I think ophthalmology as a general matter has elements of both. Clearly, there's an area in ophthalmology and depending on various companies that you cover that have a lot more tied to the sort of economic cycles that go out there. Certainly, as you closer to private pay or patient pay dynamics, the refractive areas, et cetera, you've got a bit more exposure to those economic cycles. I think for something like glaucoma care and even, quite frankly, keratoconus care, where the patient needs to have something done. Those tend to be a bit more insulated. It doesn't mean that on the margin, people don't make pocketbook decisions around that. But for the vast majority of those patients, that's not really an option. They need to get the care.

Joanne Wuensch

analyst
#20

So let's spend some time on the pipeline. You have a few products coming out. iAccess was launched last year. Can you sort of give us an update on where that fits into the continuum of care and also an update of adoption at this stage?

Joseph Gilliam

executive
#21

Yes. I think -- so starting with iAccess, it's a part of the algorithm. I mean the way we look at it is the evolution of care, whether that's based upon the evolution of doctor algorithms or economics, we want to make sure that we have solutions available for our customers and have that available. In the case of iAccess, for those doctors who feel like a goniotomy is warranted, whether it's done on its own or with other procedures in parallel. I think we want to make sure that, that's part of it. And like everything, when we go like that, we try to make sure that we are providing a meaningful innovation and providing alternatives that are for the betterment of the patient. And I think iAccess has that potential. Having said that, it's obviously always going to be a relatively small portfolio. It's different price point, it's used in a different -- most often in different disease stage in terms of severity. And so while it's getting utilization. There's no doubt about it, and we're approaching a year on the market with it. It sometimes can get lost in the shuffle in the context of the way you all as investors looking at from the outside [indiscernible].

Joanne Wuensch

analyst
#22

So almost a year ago at -- I think it was ASCRS [indiscernible], one of the meetings. There was a big discussion of where does iAccess fit? And this concept of stacking reimbursement codes and stuff like that. Is that behind us? Or is that still in discussion?

Joseph Gilliam

executive
#23

I think reimbursement is always an evolution, but let me just clear up 1 thing. You heard consistently from us on earnings calls that iAccess had all the features and benefits that made it capable of being a goniotomy device reimbursed on that. I know there was some confusion around that. It really is a universal tool and the way it can be utilized. And so surgeons based upon whatever the reimbursement dynamics are or their own surgical preference and what they think is the need of the patient can certainly utilize that tool accordingly. I think that in the context of whether doctors are doing it in combination with other procedures, has a lot to do with the individual MACs and commercial carriers there, they're on surgical preference. And I think it's something that will continue to evolve. I mean a lot of these docs who really believe in this are investing in creating the clinical evidence and the various things that ultimately support reimbursement. So I think it's a journey on that front. But for us, it's about having as a part of the portfolio and doctors can utilize it how they deem as appropriate for the patients.

Joanne Wuensch

analyst
#24

Okay. Anything else iAccess you want to comment on before we move on?

Joseph Gilliam

executive
#25

I think we're good on iAccess.

Joanne Wuensch

analyst
#26

Good on iAccess. Good. What about infinite? For those who don't know the product, you want to briefly explain it and where that fits in the continuum of care?

Joseph Gilliam

executive
#27

Yes. Well, so first of all, it's based on our core technology that we know today with Inject-W, in combination of cataract surgery. It's a 3-stent solution. It's a redesigned injector system, which we think provides increased utility for the surgeons and facilitates the utilization of the device. Probably most importantly in it is it's our first real entry into the stand-alone or interventional market. And if you think back for Glaukos 20-plus years ago, the reason we created the company was to be able to go after the broader continuum of care in glaucoma. And the FDA was a little bit more cautious about that in one of the combination cataract procedure to go first. So for us, it's the fulfillment of a 20-year journey to be able to start treating these patients in a more stand-alone setting. And so we were pleased to get clearance of that late last year in patients who have more advanced patients who failed medical and surgical therapy. And we're now in the process of navigating the MAC consideration processes and turning on the coverage of that important product for us.

Joanne Wuensch

analyst
#28

So can you remind everybody the size of the population that infinite targets? And I'm going to add to this, what is the MAC process? What's the timing of that?

Joseph Gilliam

executive
#29

Okay. Well, I'll start with the MAC process, and we can [indiscernible]. Yes. Well, I don't know if it's actually anything involving reimbursement is never easy. So in the past, it's been a 6-to-9 month process for us. when we've gone through that. And basically, you're opening up the conversation with the MAC to make sure that you get a codified policy in place, which really reassures the accounts in terms of what they'll be paid and on a consistent basis. In the interim period, you go through more case by case. So you're navigating, you're adjudicating each one of these things and whether they've launched a prophy or not, you tend to be in hand-to-hand combat in terms of making sure these things get paid. The overall market opportunity is really a matter of evolution. I would say that the lowest hanging fruit, if you think about the -- those patients who are more severe in advance and they've failed surgical and medical therapy and they may be headed down the path of a very invasive procedure in terms of trabeculectomy or tube surgery. The best data we've got is there's 125,000 to 150,000 of those surgeries done a year. If you think about most doctors want to utilize that kind of right ahead of that more invasive procedure, maybe it's, let's call it, 200,000 potential procedures a year, which is, for us, a very meaningful market that we think from a doctor perspective, becomes a pretty straightforward conversation for them to have with their patients at that stage of the disease. Over time, as we've talked about, we're investing in additional studies to continue to expand that label and hopefully get into the mild-to-moderate stand-alone patient population. And as you go there, it could be 0.5 million or more procedures a year in the U.S. A lot of that depends on iDose and the various things that can potentially cannibalize each other as it thinks about the continuum of care for those patients.

Joanne Wuensch

analyst
#30

But in terms of getting a professional fee and going through the MAC and everything else like that, where are you on your journey?

Joseph Gilliam

executive
#31

Yes. So we're in the initial phases where you make the application and you go through all that, they acknowledged it's a valid request and then you go into open meetings and drafts and everything like that. So I'd say it's -- we're on schedule, but it's a relatively early innings.

Joanne Wuensch

analyst
#32

So is that a year process?

Joseph Gilliam

executive
#33

It can be a 6-month process. It can be a 9-month process. There's no statutory time. It could be a year process, but the -- our historical experience has been it's a 6- to 9-month process.

Joanne Wuensch

analyst
#34

Okay. And then a code will be created at one of the MACs or at several of them? Or how do you -- where are we going with this?

Joseph Gilliam

executive
#35

So we have the code. And what you're really looking to do is have the coverage turned on so that it's no longer case by case or a noncovered depending upon the MAC. And they'll crosswalk that code from a professional fee standpoint to the nearest Category I code. So they'll establish a professional fee. Reminder, the facility fee is already established. It's more about coverage of that, but they need to establish the pro fee because it's a T code.

Joanne Wuensch

analyst
#36

Okay. So once that's established, you start marketing it? Is there a wait list of people who want the procedure done? Are doctors clamoring to be trained?

Joseph Gilliam

executive
#37

Well, I think some of this is already happening. I mean, to be clear, we're already selling iStent infinite, right? And there are settings that are there within these MACs, we're adjudicating each of these claims. So we're out there doing that. I hope that as people grow enthusiasm and they know these patients that if they can avoid that tube or trab and they can hold off for us to make sure they're going to get paid appropriately if that's the case. But I think that for the most part, doctors are going to do what they need for the patients. And if that means doing the procedure even today, hopefully, they're doing that. We are marketing it. It's commercial, it's approved. But to your point, you start putting a lot more fuel in that fuels lodge when you get to the place where you have fully established reimbursement.

Joanne Wuensch

analyst
#38

So you have the same sales force for all of the mix products? Or do you have some -- Okay. And so put me in the seat of I'm a salesperson or I'm a physician, I'll let you take which one, and you're coming in, how do you walk through the portfolio so that you get the doctor's attention to the products you want him or her to focus on?

Joseph Gilliam

executive
#39

Yes, I don't think there's a one-size-fits-all process, right? In many ways, it has to do with that individual surgeon and where their algorithm is at and who they see, right? So as you know, comprehensive doctor versus glaucoma surgeon is 1 thing. Are they more inclined to use goniotomy or are they a stent-based? Do they see more stand-alone glaucoma? Or is the vast majority of their volume combination cataract. I think you really have to tailor that conversation based upon that and where that patient -- or that surgeon's algorithm is at the time. I think the biggest conversation that we have to be having as a sales organization is about raising that awareness of the stand-alone opportunity and the interventional glaucoma opportunity, making sure that these doctors are thinking on a day-to-day basis about opportunities or areas where they can intervene on behalf of the patient to hopefully put a bullet in the progression of the disease or at least slow it down considerably. So I think that's a new mindset as technologies are becoming available and approved for stand-alone care. It's going to be a big push for us as a commercial organization.

Joanne Wuensch

analyst
#40

Where does your commercial organization stand today versus 12 months ago?

Joseph Gilliam

executive
#41

Pretty stable, yes. So first of all, we've had a long track record. I think it speaks to the quality of the organization in terms of retention of our commercial organization and sort of voluntary turnover, if you will. But in terms of the overall intent of sizing of the organization, we're pretty stable. We continue to add a rep here or there depending upon territory size and if things get too large, but we're quite stable.

Joanne Wuensch

analyst
#42

I'm very proud that we've waited all this time to talk about iDose because I spend a lot of time with investors on it. What -- and you recently submitted something to the FDA. Can you give us an update on where you are with the regulatory process?

Joseph Gilliam

executive
#43

Yes. Well, thanks for that. We announced on Monday that we had submitted. In some ways, it's the start of a fulfillment of a very, very long journey. And there are a lot of folks inside the company who have been working on this for well over a decade. And the actual submission I have not read every page, but I'm told it was over 90,000 pages of submission to the FDA. It's a massive undertaking, right, for the organization. And so for us to get that in, next step with that is obviously for the FDA to do their official acceptance of the application over the course of the next 60 days or so and establish a PDUFA date.

Joanne Wuensch

analyst
#44

Okay. So you're still on track for end of year approval?

Joseph Gilliam

executive
#45

We are. Yes.

Joanne Wuensch

analyst
#46

Maybe earlier.

Joseph Gilliam

executive
#47

I don't know about that. I think what we've said, I think we just said on the earnings call is we're comfortable by the end of the year, the FDA has their time lines and processes, and it tends to be with these type of applications that they center around 10 months. And so things could be a little faster, it could be a little lower, but that's the estimate.

Joanne Wuensch

analyst
#48

Do you think investors are overfocused on iDose?

Joseph Gilliam

executive
#49

I'm not sure they're focused on it enough, but -- no, I mean I think that the attention shifts and for good reason as it becomes closer, it becomes more of a reality and folks who are trying to think about how to best model it or incorporate it into their own investment thesis, I would -- it's only natural that people would try to get their arms around it. I also think for a company that is historically more oriented towards medical technology, MedTech type investors. Some of the things that go along with a drug or a drug device combination are new or require reeducation, we're happy to do that.

Joanne Wuensch

analyst
#50

So let's pull this apart a little bit, approval by the end of the year, reimbursement when?

Joseph Gilliam

executive
#51

So you have to break that down into the individual sort of lanes of that reimbursement. The facilities, the codes that exist today, the T codes that are there, that are currently sequestered or dormant until we turn them on, really play a process, not that dissimilar than iStent infinite. So the facility fee will be established. The coverage of that, the pro fee, Crosswalk, all the things we just talked about with iStent infinite will be a reality for iDose as well as we enter into 2024. In parallel, the drug itself. So where our revenue comes from will be a pass-through. And so for that, you'll establish pretty quickly a miscellaneous code that ultimately within a quarter or 2 after that, you'll get a permanent J code established. The combination of all those things coming together and very similar to iStent infinite. It's not a black and white seminal moment where this all turns on. It will be turned on kind of methodically over the course of that period of time. But ultimately, once they all come together, then you really can put the full sort of muscle behind the commercialization of that product.

Joanne Wuensch

analyst
#52

So the muscle going behind the commercialization. I'm making this approval second half of the year, 2 quarters for -- to get a J code start to ramp revenue mid-'24?

Joseph Gilliam

executive
#53

Well, again, I hope that there's revenue contribution throughout 2024, but there's clearly going to be an accelerating effort behind it and hopefully sales associated with it as we make our way through the year.

Joanne Wuensch

analyst
#54

And you need a new sales force for this or it gets into the bag?

Joseph Gilliam

executive
#55

No. Straight into the existing surgical glaucoma sales force.

Joanne Wuensch

analyst
#56

And this surgical sales force, are they used to selling a combo pharmaceutical medical device product?

Joseph Gilliam

executive
#57

Yes. I mean I think for the things that matter for them, right, they're very used to this. And these are experienced sales reps who are comfortable in the OR, comfortable carrying multiple products. I'm not so concerned about their ability to carry iDose. Now that doesn't mean that we haven't made substantial investments in other areas of our commercial organization, right, whether that be enhancements the way we're thinking about it from a marketing perspective, market access with payer coverage and all the various things that go there. We are making a lot of other investments to help make this go. But we have a pretty good road map from that -- from our Photrexa and Corneal Health business. It's not our first time down the path of a drug device combination or a drug for that matter. So we have a pretty good sense of what it takes, and it's just about executing and scaling that against iDose.

Joanne Wuensch

analyst
#58

So why do you think investors aren't paying close enough attention to it?

Joseph Gilliam

executive
#59

No, I think they can never pay enough attention to it. Again, I think back to when Glaukos went public, right, even then a big part of the conversation was combo cataract mix is great, but when are you going to be able to realize the dream of interventional glaucoma and ultimately, iDose is a part of it. And so for us to kind of finally hopefully be on the doorstep of some of that is super exciting. So we welcome any and all investor attention. It may not be that we're willing to answer all the detailed questions at this stage of the game, but that will all become apparent as we turn the corner into next year.

Joanne Wuensch

analyst
#60

So let's talk a little bit about Phase II data for elution for dry eye disease. Help me understand how Glaukos gets into dry eye?

Joseph Gilliam

executive
#61

You mean from a commercial perspective, development perspective?

Joanne Wuensch

analyst
#62

Every aspect of it. I mean because seriously, you were a MIGS company then you're -- multiple products in MIGs, then you've got combo pharma med device, now you're getting into dry eye, and I have absolutely no doubt that there are visions for others things kind of intended.

Joseph Gilliam

executive
#63

Yes. I mean I think about it a little bit differently. I think about it is we've always been a pioneering company, maybe it's an overused term, but the reality is, if you think about it, there's different ways to approach building a business. One is you try to create a market and there's others where you try to build a better mouse trap, we try to do something very differently. The history of MIGS, the history of our keratoconus therapy, these are all very different types of technologies and approaches than ever existed prior to them there. And you build a core competency around that, right? How do you launch truly disruptive technologies? How do you navigate all the fund and uncertainty around the reimbursement of these things and have conversations with investors around it, too. I think with the iLution platform, you have a totally different way of approaching drug delivery, right, or really just drugs themselves. It's a pretty universally, potentially applicable platform where in a simple application of a topical cream, whether it be to the upper eyelid or both eyelids can deliver these drugs. And in the case of dry eye, we would not probably have gone directly into dry eye disease or presbyopia matter, et cetera, with a typical drop base that would have been much further down our life cycle. But when we came across a potentially transformational technology platform, that's what led us there. And so there's a whole other element of that business that would have to be built to the extent that this ultimately prove that to be successful. But I hope we'd be doing that in sequence with what would already then be a successful iDose franchise and as well as with Epioxa on the corneal side. So it would be a natural next evolution or a phase. And there's a lot potentially under the hood there with that iLution platform.

Joanne Wuensch

analyst
#64

Where -- what are you thinking in terms of M&A?

Joseph Gilliam

executive
#65

I think the bar is always high, right? I mean I think at this stage, we probably have a pretty good track record of what you can expect from us. I mean you never say never, but we have so much going on organically and so much to appropriately fund that and do all the right things by that -- our organic opportunity that we tend to prioritize transactions where we think we can create a win-win versus something more sizable that probably gets attention of investors. But we're always considering all alternatives.

Joanne Wuensch

analyst
#66

So given all of this, your gross margins have been really healthy in the 80s. Does it stay at that level as you layer all of these new products on?

Alex Thurman

executive
#67

I'm going to give him a break [indiscernible] question. Actually, we're blessed to have a very healthy, as you said, gross margin. We like this range of 83%, 84% which for our company is wonderful. It gives us a lot of flexibility. Is there potential for it to rise over time? Absolutely. But for now, we'll stick with the range that we've given guidance on, and we'll see how it all plays out over the next few years.

Joanne Wuensch

analyst
#68

Very few people talk about margins at this level rising. What stops them from falling?

Alex Thurman

executive
#69

Well, the fact that it all depends on the product mix, right, and what those -- and you get into these drugs like an iDose product that have a high margin that could keep it from falling.

Joanne Wuensch

analyst
#70

Higher than 83% to 84%.

Alex Thurman

executive
#71

Potentially, yes.

Joanne Wuensch

analyst
#72

Okay.

Joseph Gilliam

executive
#73

Separate reimbursement plays a big role, right? So, as Alex mentioned, mix and reimbursement. Obviously, we've all seen inflationary pressures on the cost side, but we've been pretty immune to that, I would say.

Joanne Wuensch

analyst
#74

So that gets me through the gross margin question. Now I'm going to go to the next one. Okay. How do you manage operating expenses so that the company is moving closer to a breakeven scenario.

Alex Thurman

executive
#75

Right. So that's kind of the focus, right? If I take you through historically, our company has always been one that has lived within its means and we got to a point in our life cycle where we had iDose coming. We had infinite coming. We have Epioxa. We have other things. We have this huge pipeline and it became apparent to us that we needed to enter into a phase of investments. And we're in that phase right now. 2022 was an investment year, 2023 will be an investment year, but we've built the balance sheet to be able to do that. And so once we get through this period of investment, we get to the other side of iDose, that's where we start to see that pathway to breakeven and profitability.

Joseph Gilliam

executive
#76

The good news is Alex has -- and Tom for that matter, have a lot of flexibility in the levers they pull. So the gross margin profile you started provides a lot of opportunity for them to adjust up and down how much of that investment we want to make.

Joanne Wuensch

analyst
#77

Are you ready? Or have you shared publicly a goal towards breakeven?

Alex Thurman

executive
#78

We've not shared a goal, no. Just we've always said we'll start to look towards that pathway once we get on the other side of iDose.

Joanne Wuensch

analyst
#79

Okay. Most of your sales are in the United States. How do you think about pushing further outside the United States?

Joseph Gilliam

executive
#80

Well, I think right now, the exact numbers were like 25% international maybe a little bit more when you include the Corneal Health piece of it.

Alex Thurman

executive
#81

Yes. 25-25-50, call it.

Joseph Gilliam

executive
#82

In mature ophthalmic markets, you tend to see at about 50-50 between the U.S. and international. Obviously, again, we're pioneering new markets. So I think that the U.S. will always lead and if iDose is as successful as we think it is, it will probably weigh even more towards the U.S. for a period of time. And the international market will continue to be following. But we're still in the early days there. We've established a nice foothold in the major European markets, the major other international markets, Japan, et cetera, that you'd expect. And we're emerging in some of the other, I'll call it, higher growth earlier-stage markets. So I feel good about the trajectory that business is on and the opportunity over the long haul.

Joanne Wuensch

analyst
#83

What markets are you in mostly outside the United States right now? Where is the greatest foothold?

Joseph Gilliam

executive
#84

Well, we're in 16 or -- 16 international markets. It's all the major ones you would expect. I mean we're throughout Europe, we're in Brazil, Canada, Australia, Japan, being the biggest markets that are there. In the EU, you can imagine it's -- depending on how you look at the EU3 or the EU5 that drive the big chunk of those revenues. But what we have seen consistently over the last several years is pretty broad-based growth across the board because we're still teaching and growing these markets from the infancy as sort of where the U.S. was nearly 10 years ago now.

Joanne Wuensch

analyst
#85

Is the adoption of the products there as robust? Is the reimbursement in place? What's -- the assumption I'm getting out what's holding you back from sort of...

Joseph Gilliam

executive
#86

Every market is completely different. And every market has its own challenges. I'll give you example. There's -- I forget how many provinces there are in Canada. And we've got almost all of them, but I think I'll get it wrong, but 1 or 2 of them are still not fully reimbursing. And Germany, the same thing with the . And so it is -- every situation is different. Some of them more nationalized in the U.K., we've got full coverage there. So it just is a situation-by-situation basis, and that's where you invest in your market access organization everything else to continue to drive that forward, and we've been successful in that. But that's where it takes time, it takes time. These are not existing cardiology codes that have been around for a long time. And sometimes they'll come out and they'll have something where they are incentivizing the wrong thing. Maybe it's a stand-alone glaucoma instead of combo cataract, you got to go fix that just part of the process.

Alex Thurman

executive
#87

France is a great example as well. We entered the market in 2017, but we didn't get on the [indiscernible] until 2019, maybe 2 years, and then it took off.

Joanne Wuensch

analyst
#88

So it just takes time. Do you think -- trying to how to word this. Do you think there are too many things on your plate? Do you think you need more on your plate [indiscernible].

Joseph Gilliam

executive
#89

Did my wife plant that question. No. That's going to be a transcript. No. I think we're always thinking about that balance in different parts of the organization. And it's funny sometimes you're looking a little bit more too dimensional than maybe we do, which is it's about the stages of these things, right? And so when we talk about retina, for example, which we haven't talked about here, that's still pretty early stage. And so the translation that into something that we'd have to be thinking about commercially as I think about it, it's still quite a ways off. So right now, the focus depending on where you're at in the organization, is very different. So we've got a ton of focus on building interventional glaucoma around the U.S. glaucoma opportunity around Epioxa and delivering that in the cornea side. And we still have some time to go before we have to think about iLution and dry eye disease and those kind of things commercially. So I think it's more about stage gating these things appropriately. And part of it is the bubbling cauldron theory of investment. You don't always know what's going to rise. So -- and you don't always know where reimbursement things may change or the commercial landscape may change. And so I think for us, that's about staying nimble and making adjustments where we need to on the fly and the more opportunities you have there, I think the better so far, so good in terms of us managing it.

Joanne Wuensch

analyst
#90

Do you think the ophthalmology market, and I'm talking companies and, I guess, physician consumption of products at the current time in the macro environment, just to be specific, is stable?

Joseph Gilliam

executive
#91

So do we think that the overall ophthalmic market is stable in that context?

Joanne Wuensch

analyst
#92

Or improving or declining?

Joseph Gilliam

executive
#93

I think it's stable to improving. Again, I think probably the 1 headwind that still remains is this idea of the staffing issues. And so I think -- remember, this is a very ASC-oriented, independent oriented business, if you will, as an industry, and so the more dollars that we're flowing in the hospital channel towards acquiring these folks, the turnover is higher in the practices. And so I think that's probably -- if you talk to a broad swath of ophthalmologists about macro fundamentals, it's the thing that would probably stand out the most for them in driving that. But beyond that, it still feels healthy. There's a lot of new doctors coming into the funnel. Patient demographics work. And in general, while we'd always like to see better reimbursement, these things are still getting paid both in terms of the public sector and the private sector. So I feel pretty good about the macro setup.

Joanne Wuensch

analyst
#94

So for my last question, we're here this time next year, what are we going to be talking about?

Joseph Gilliam

executive
#95

Well, I a lot of ideas. No. I mean I think -- and also I think people will start dialing in a lot more around -- what does it mean for stand-alone care? What does it mean for interventional glaucoma? How do you really start slicing and dicing that in a way that both makes sense in terms of the practical aspects of it, but then ultimately translates into the way you model the opportunity over time. I mean this is not a drug that's a pill that you just prescribe it and run. We have to build that market. I think people will be dialing that in a lot more this time next year.

Joanne Wuensch

analyst
#96

Excellent. Well, thank you very much for joining us today, and I hope you have a great day.

Joseph Gilliam

executive
#97

Thank you.

Alex Thurman

executive
#98

Thank you for having us. Thanks for all of you guys sticking it out after lunch. It's tough.

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