Good morning, everyone. My name is John Young. I'm one of the senior med tech analysts here at Canaccord Genuity. Thank you all for joining us for our 44th annual Global Growth Conference. I have the pleasure today to introduce STAAR Surgical, and with us today is CFO Patrick Williams. As a disclosure, I'm a very happy STAAR patient, so take that into account. Thanks, Patrick.
His reading doesn't quite reflect that, but that's okay. Good morning, everybody. As John said, Patrick Williams, and super happy to be here. Been coming here for a long time. Thank you, Bill. Known Bill for a long time with various companies, but, yeah, let's get started. So forward-looking statements, you can find this entire deck and other decks on our investor relations website, some non-GAAP financial reconciliation. So we just completed our Q2 earnings call, and it was a busy earnings season for everyone. A little tough out there for med tech, certainly. So what we tried to do was showcase what we believe are really kind of five compelling reasons as to why you all as Wall Street folks should be interested in investing in STAAR. I'll break down these pretty quick.
We'll go through product, market, people, places, financial model, and then where we think we're building a ton of momentum as we move forward. Little word cloud, we've been using a little bit of AI to try to better understand the sentiment out there. I know a lot of you've been seeing that more recently. So what is it exactly that we do? So John talked about it a little bit. Think of it as essentially an alternative to LASIK. A lot of people know what LASIK is. I see people out here with glasses right now. It's really a permanent contact lens is the way I describe it, but it's got a lot of really good benefits over LASIK. I'm a LASIK patient.
I had it about 15, maybe even 17 years ago now, and certainly I wish I had known about this product, and I can talk a little bit about that when we get into the differences between a cornea-based procedure, which we call LASIK, SMILE, PRK, as opposed to our procedure, which is lens-based, and we call that our EVO ICL lens. In the middle here, you see six squares. Those are really kind of the real benefits that we talk about in terms of how EVO ICL or a lens-based approach can be very different than a cornea-based approach. Very quick recovery, we're additive, we're not removing any tissue. When you remove tissue, that causes a lot of problems. It reduces clarity of vision, quality of vision. You have issues with night vision.
I can speak from experience. You get these things called halos and starbursts. I never thought I would be the person that would say, "I need to drive home before it gets dark." I now say that because it's becoming more challenging for me to really see at night because of the LASIK procedure I got 15+ years ago. We don't cause dry eye as well because we're not cutting cornea as well, and tissue. There is some UV protection, and I think the one that really resonates a lot with consumers that are thinking about doing a procedure on their eyes, where a lot of people have a lot of hesitancy and apprehension about that, is the reversibility or the removal, removability of it.
We have the ability to remove the lens and really bring you back to square one. This doesn't happen, but it is a peace of mind that is a selling point for the product. Very high patient satisfaction on the right-hand side. I want to focus you on the left-hand side. This product is relatively new in the United States. We had our EVO approval about, a little over 2 years ago now, but in the rest of the world, it's been approved for over a decade. We have sold over 3 million of these lens, and basically, all of those have been implanted in eyes. We have a ton of history. We have a ton of long-term clinical data. You can see the papers down here, 200+ peer-reviewed clinical data.
So there's a lot of clinical data around the efficacy and the long-term benefit of EVO. So now let's go to the market. We talk about it, we describe it as myopia. For those of you that don't know what that word is, it essentially means inability to see distances very well. And you can see today about one in every three people have myopia. What causes it? A lot of things do, but primarily the two main factors are genetic disposition, as well as environment. Our lives have changed tremendously, certainly phones, laptops, and everything else.
With COVID coming on board, we all got very comfortable and used to doing meetings like this virtually, and so that screen in front of you, that's about 18 inches away, although the person looks like they might be 10 feet away, your eyes are focusing very near or intermediate, and that's creating basically, your eyes are getting lazy, and you have the advent of myopia progression. So it's a very large market. The beautiful thing is, people every day are walking into practices asking for a refractive procedure to get rid of their glasses or contact lenses. So we don't have to create the market. What we need to do is convert more people to do EVO as opposed to a laser-based procedure like LASIK. And this is where we talk about taking market share, as I was just describing.
You can see here in the orange, this is our market share by globally, as well as some major geographies in 2018, and then in 2023, in sort of this blue, you can see where we're at. In China, which is the largest refractive market in the world, where we have over 60% of our revenue, in any given quarter, you can see in 2018, we're about 9% of the market, and now we're approaching, 20, 20+% at 2023. In Japan, where LASIK has had a very poor clinical story behind it, you can see where our market share growth has tremendously grown, upwards of 70%. And then, as I mentioned, the second-largest refractive market in the world is the United States.
We just started here, and, we're very small in terms of our market share there, and this is a real big opportunity for us, and still a long way to go from a global standpoint, with only about 15% market penetration. Just really quick on the people, I've been with the company for a little over four years now. Almost every name on this page is relatively new in the last four years since I've come on board. The board, there's only one person, Steve Farrell, who was there before I got there. Tom Frinzi actually joined the same time as I did as a board member. He moved into the CEO position, almost two years ago. And so, we've definitely added some very strong people in these different areas, as you can see here.
As I said, we just finished our Q2 results. It was a record quarter for us, our biggest quarter ever. We did $99 million in revenue, about 7% year-over-year growth. On a constant currency basis, we do have a decent amount of our revenue coming from Japan, which is in the yen. But if we normalize for constant currency, we actually had our first $100 million quarter. You can see the different areas of growth on the bottom there, 14% in the Americas, 10% in EMEA, and 6% in APAC. Very challenging quarter this time last year in terms of it was a very strong, robust quarter for refractive markets across the world. I'll talk a little bit about the macro conditions that have transpired in the last year.
We did raise our outlook for guidance by about $5 million to $340 million-$345 million. This is essentially almost the second time we kind of raised guidance. We did, after the Q1 call, hint that we would be towards the higher end of our guidance, which started out the year at about 5% revenue guidance, and we're sitting right around 7%. Our philosophy on guidance this year is to really try to reduce or remove, if we potentially could, any downside risk. So in other words, we wanted to make sure for prospective or existing shareholders that there would not be a revision down in our yearly guidance, and so far, halfway through the year, we've been able to accomplish that. As I said, I've been with the company for about 4 years.
We've generated about $150 million in organic cash during those four years. We're sitting at about $235 million right now. This number will bump back up as we move and collect cash from our record quarter in Q2. We have zero debt, and we continue to generate profitability. This affords us the opportunity to place a lot of bets and/or be able to try to drive EVO adoption across the world. I kind of hit this one already, but these are the areas where our prior outlook was and our new outlook in terms of the different geographies, and we anticipate to see year-over-year growth.
Notably, what we increased was EMEA from a guidance standpoint, very strong results in our direct markets like Germany and Spain, and then we did increase the U.S., which had its first $5 million+ quarter in Q1, and we did $5.5 million in Q2. On this slide, these are different levers that we can pull and use some of that cash that we've generated in order to invest and try to drive further adoption. I do want to talk a little bit about the macro conditions that are out there. Certainly, it's been very challenging. The refractive markets across the world are down. There's no... We are a consumer pay, cash pay product, and so we are not immune to that.
But as we like to think about this, these things go through cycles, and right now we're in a bit of a downward cycle. We're seeing markets such as China potentially only grow. In fact, it's retracting, maybe to the point of 10% year-to-date on a year-over-year basis, but we continue to take market share. And so in the APAC region overall, we were still able to have positive unit growth on a year-over-year basis, even in a market that's retracting. I did want to spend a little bit of time on this slide. Excuse me. So what you see here is kind of a product roadmap, and a lot of times when companies show this, these are meant to be two or three years out, looking.
These are things that are happening within the next six months or within the next six to 12 months. We just launched our new ordering system, which makes it easier and more efficient for doctors to order. We're about to open up our experience center, which is a state-of-the-art ability to not only video out surgeries or training, I'll call it, not live surgeries, but on models, but also, at the same time, be able to host a lot of surgeons and be able to really utilize this and give a corporate touch to doctors around the world to be able to come in. We've collaborated with some doctors recently to increase surgeon confidence with different AI tools, and we're also developing some internally.
This is an area where we believe if we can increase surgeon confidence, that we recognize in both the measurement and size selection of our lens, then we have the ability to further drive adoption down that diopter curve. We talk about harmonizing labels. That's another way of saying, expanding our label indication. In most of the world, we're expanded from age groups of, call it 21 years old, all the way up to 60, and we have the ability to do a full- range of myopia, meaning all the way down to minus a half diopter to upwards of - 20. In the U.S., however, we only go down to - 3, and our label expansion stops at the age of 45. So we are working, closely with the FDA to try to expand our label. Once again, we'll just increase our addressable TAM.
I talked about the fact that we believe we have a very differentiated product. We have begun talks and an investigator-initiated head-to-head study. This will be EVO versus LASIK, and so we're gonna see what the doctors say, but we fundamentally believe that this will be a study that will show the benefits, especially around the quality of vision, the satisfaction of patients, certainly, but really that quality, that recovery of the product that EVO has versus a cornea-based procedure. And then finally, kind of wrapping it up, you've got the investment case that I spoke about, and you can see the five reason here, and with that, we'll have John come up here, and we'll do some questions. Thank you.
Thanks. Great overview. Awesome. Well, yeah, thank you for that overview. It was really great. Maybe we could start on guidance. So you had a very strong Q2, especially in the U.S., where you saw 25% growth. And notably, China held in, which I think was against some expectations, just given how much of your med tech peers have highlighted just, you know, the significant headwinds there, and it was during your seasonally important Q2 as well. You know, as you stand here today, can you just talk about the momentum in the business that you're seeing that led to that guidance raise that you just spoke about?
... Yeah, look, it's as I mentioned during the talk, it's been a bit of a challenge out there. The China market was probably down 5%-10% in Q1 on a year-over-year basis with units, probably 10%-15% in Q2, yet we were still able to grow. We have historically been able to take market share. I didn't have that slide up there, but if you go on investor deck, you'll see a multi-year slide that shows how we've taken market share across the years and in the various geographies.
As I said, our philosophy this year was to try to really put out a number that we felt mitigated as much as possible, any downside risk, and taking into account these macroeconomic factors, not just in China, but in other parts of the world, including the U.S. And so, we felt very comfortable with how the China market was doing, certainly in the first half of the year, on a very tough comp. The comps do relieve in the second half of the year, not just for China, but for other parts of the world. It was a challenging second half when the economies across the world started having some issues. So, we feel good, and, you know, as we said during our Q2 call, the high- season, as we call it in China, is going very well right now.
I would describe it as, you know, we're holding our own on a year-over-year basis, and clearly we're about halfway through that high- season. So we'll have to see how the rest of August falls out in September. And that'll certainly predicate then what we do for the balance of the year in terms of guidance in Q3 and Q4.
I know I can't get a 2025 number out of you, but I'm gonna try.
Sure.
Just because I feel like for the Q2 call, you had a great quarter, and you maybe didn't get the full credit because investors are starting to look at 2025. I know consensus today sits at about $395 million for 2025 revenue. But in light of all these macro conditions, and also in light of the LRP that you had out there, the 15%-20% CAGR through 2026, you know, clearly China has really changed the macro conditions there since you gave that LRP out, too. And I know it hasn't been withdrawn or anything like that, but can you just talk about maybe holistically, 2025 and 2026 growth and what investors should think, and maybe any comfort around that $395 million-dollar consensus number?
Yeah, no, it's a fair question. Look, we did put out a LRP. It was almost a year ago, actually, coming up on a year, so we did it in September 2023. So, a couple of thoughts before I address sort of the chatter maybe that's out there. Number one, we just finished the seventh month of a 36-month journey into our three-year plan, and so, we still think we're in the early stages of it. Number two, even when we gave that original LRP in September 2023, it had accelerated growth. There was no doubt that we talked about that year two would be higher than year one, and likely year three was gonna be higher than year two.
That building momentum slide that I have up there right now, that's still up there, those are the things that we have been actively working on. It is a new management team. As I said, Tom came on board about 18 months ago. He started in January of 2023. And so there's a lot of good stuff that we're working on, and why I wanted to focus on that product roadmap slide, it was important because these are things that are really happening in the near- term that we believe will drive accelerated growth. So with all that said, though, things are very different. The macro economy a year ago when we laid that out, was very different in China. We did not expect that China would be 10% down halfway through our first year on a year-over-year basis.
Look, we try to believe that we listen to the Street. Clearly, we had a strong quarter, as you said, the stock didn't react as maybe as well as we had hoped. Potentially, there is the words that you all use, an overhang, or at least concern around the ability to hit that 25 and 26 number. We are actively thinking about it and how we should address it from a Wall Street communication standpoint. But as you said, I think for now, we're gonna stay the course. But we do realize that it's an area of concern for investors, and, we should address that.
We are thoughtfully thinking through what the best way to make sure that we can keep that same philosophy that we spoke about or I spoke about before, which is: How do we mitigate downside risk for potential investors? As some people like to say, give a reason to own the stock. So, we are thinking through it, and I appreciate the question, but not quite ready today here to change any numbers on anyone at this point.
I wouldn't be doing my job if I didn't ask, at least. But, U.S., I mean, strong momentum there year to date. You noted Highway 93, which is your accounts that you've identified that have the really, the factors for success. They grew 29% year-over-year in Q2. Can you just talk about how you're engaging with these accounts? What's working, how many-- and I know it's no longer 93 now.
Yeah.
How many are there out there that you've identified? Maybe you could just talk to investors about what criteria you're seeing in those accounts that really seem to click.
Yeah. So as I described, our job is not to necessarily bring potential patients into the office. Our job is to try to figure out how to convert more of those patients to EVO customers versus LASIK customers. And so clearly, the one of the gatekeepers there is the doctor and their practice, right? And so part of the stuff we talked about is how do we increase surgeon confidence in measurement, size selection. I talked about some of the tools that we're working on with that. What we did when we identified this Highway 93, which is now over 100, is really identify those practices where they're at least talking the talk, and now we're trying to get them to walk that talk. And what do I mean by that?
They've talked about the fact that, let's say, when a -6 walks in the door, which we would call maybe a mid-myope, that they would absolutely think of EVO as the first choice for them. There's no doubt that as you move up the diopter curve and you have to cut more cornea, and in some cases, you're not even a LASIK candidate anymore, we're easy. We're able to monetize that patient when they come in, where the doctor could never monetize before. And so that's a good thing from that standpoint. What we need to do is to have the doctors continue to talk about the benefits of EVO as you move down the diopter curve.
So we've sort of drawn a line in the sand at -6, and those doctors that had said, "I will think of you as the first choice or the only choice," we'll call it above -6, and below -6, you are a choice. Those are the ones we're focused on. We also look at setting of care. There's no doubt about it that the setting of care can make a difference from a cost standpoint. In order to do our procedure, you need to be in a higher sterility area, so we call it an office-based suite or potentially an ambulatory surgery center, an ASC. And those require some cost from the doctor in order to do that.
And so those are the areas where some of these doctors, about a third to 50% of them, have economics that are either an ASC that they own and/or an office-based suite within their office. And so those are the ones we're focused on, and we've seen some pretty good return on that, to the point where I would say drive deeper as opposed to wider. And those practices are really driving a lot of the revenue that we have in the U.S. Again, it's a pretty small number. We did $5.5 million in the U.S. in Q2 on a $99 million total revenue. But we appreciate that a lot of the investors that are US-based are highly focused on the U.S., so they can do their channel checks, et cetera.
Great, and then, you know, the shift in marketing, too. When you initially launched in the U.S., it was a big global marketing platform, Joe Jonas, all these, you know, really great, you know, you know, celebrity endorsements.
John Young.
John Young. I don't have the same amount of pull as him, unfortunately, but we can work on that.
Mm.
You know, you've really converted now to practice-oriented marketing, especially with co-marketing, too. Can you talk about how many accounts have engaged in that so far? What you're seeing so far with that, too, and then also, are there other products that these practices are using that are kind of used to, you know, using co-marketing dollars with, so it's an easy ask for them? Just talk about that.
Yeah, you know, I've been involved in cash pay med tech for a little bit of time now, and you have to understand that if the doctor is not readily comfortable, and the practice is not set up to convert your potential patient coming in the door, and they've got another device, an alternative device that's very easy to do, which is LASIK, it's a bit of an uphill battle. So one of the areas that we've really learned a lot, I would say, in the last two years is this concept of increasing surgeon confidence in measurement, size selection, making the procedure easier for them and more predictable. For the first time in the company's 30-year history, at JP Morgan this year, we actually put in our press release that we have to invest more in increasing surgeon confidence in our procedure.
That's a pretty big wake-up call, if you want to call it that. So we've spent a lot of time better understanding what that means and how we can bring that physician along on that journey. I bring that up because when we did invest the money in DTC, all of the data that I was seeing from a hits, Google Trends, et cetera, should have resulted in some very, very high revenue based on historical trends that I've seen in my career and other companies that have done it. But the issue was this: patients were walking in the door, and the doctors loved us for doing it, and the doctors were just simply converting them back over to LASIK very easily and clicking that button.
So there is clearly an economic model, a physician comfort model, that we have been working through, and that's why you've seen us in a tough market to be able to continue to take market share. And once that market flips back to being a little bit positive, I think you're going to see growth numbers that will support more of that LRP as we move forward. And so, we did move dollars down to the practice level at the time being. That's a very normal thing until we really get that critical mass, and we're very comfortable using our experience center, as I mentioned before, training more doctors, et cetera. Then we'll look to bring DTC back up and probably pull away, as you normally do, from sort of practice, and then you have more of a general brand awareness model that you'll do globally.
Great, and then maybe just the last one in the U.S. before we move on to China, but just the, the FDA meeting, the harmonization, the product labeling, are you gonna use existing data? You're gonna at least try to use existing data to get a label expansion there? Just any additional color on that.
Yeah, clearly, the ability to use existing data is always quicker.
Yeah.
And so what I would describe is we have a multi-pronged approach, but clearly, you're gonna go to any regulatory body, whether it's the FDA in the U.S. or someone else, and try to use existing data. The good news is we have a lot of existing data. Now, a lot of it is based outside the U.S., but we have a ton of U.S. data as well, including our recent clinical trial, where we got the PMA supplement for EVO Plus in the U.S. a couple of years ago. So, more to come on that, but as I said before, these things are more imminent than longer term. I call it that one slide in the next six months, next six to twelve months, and that's what we're highly focused on as a company.
I think just moving to China, you know, the overhang has been that unit growth's been down-
Yeah
... year- over- year, the first half of the year. Obviously, the implied guidance shows that you're expecting an acceleration from in the second half, especially given the comps of last year. Can you just talk about the dynamics you're seeing on the ground today there? What kind of led to that unit decline the first half and, you know, how we should think of the second half?
Yeah. So we've made some pretty strong investment in China. We recently brought on what we call a second distributor. Well, it's really more of a hybrid relationship for people that are getting new to the story. We use these distributors mostly as what I would call a logistics provider, so think of it as a 3PL. However, with the newer distributor that we brought on, a very, well-capitalized, larger distributor, they do have dedicated salespeople, and they have a much, longer reach into what we call Tier 3 and Tier 4 cities. And so, we have over 100, STAAR employees that are, China-based. We will increase that number as we continue to move throughout the year. The second distributor that we brought on, to join Lansheng, is a company called HTDK. It's a Warburg Pincus subsidiary.
As I said, they have dedicated salespeople as well. They're only, what, six months now, into it, and so they're getting, they're just ramping up, I would say. And so to get to your question, yes, the comps are easier in the, the second half of this year. We certainly will see, unit growth moving into the high single to even low, double- digits, as we move through Q3 into Q4. And so, you know, we feel good about where we're at with China, and then, of course, the question you asked is, well, what does that mean then as we move throughout this year into 2025 and 2026?
Maybe just last question here, too. You know, clearly, your business in China is somewhat protected. You know, the laser vision market down, market there was down 10% in the first half, but also, so many other vision companies have had to reset China guidance. You have not. Can you just talk about what's making your business more comparatively defensible? Is it just because it's cash- pay, anything like that? And also, can you talk, like, on the topic of defensibility, local competition, too?
Sure
... and just how you're gonna be factoring that in as that acrylic-based lens comes to market?
Yeah. So on the competition side, look, we're not one of one, as I like to describe to people. We're one of maybe 20. And what does that mean? There's been upwards of 20+ companies and/or products that have tried to do what I'll call a permanent or an ICL, implantable contact lens. We're the only one that's really survived that and has a lot to do with our unique material, which I didn't spend probably enough time to talk about. But that gets to the real question which you had is: Why are we able to continue in a down market with LASIK to take market share? It's the quality and it's the clinical benefit of our product that it delivers, and if people are gonna spend their hard-earned money, they want to get the best thing that's out there.
So our product continues to be a premium price product across the world, and people are willing to pay it. We still need to figure out what that price elasticity looks like exactly, when we compare ourselves to LASIK. But I would say that's one of the main reasons, is our clinical benefits resonates with the patients, and certainly, the doctors are seeing the benefit as they move down the diopter curve. For people such as myself, that was a - 5.5 when I got it, that EVO was probably a better choice for me in order to keep my eye healthcare optionality as I proceed through my life.
Great. Thank you so much for joining us today, Patrick.
Appreciate it. Thank you.
Thanks.