Next, Fireside. We are thrilled to have RxSight, and we have RxSight CFO, Shelley Thunen. Shelley, welcome. Thanks for doing our conference this year. Really appreciate it.
Thank you very much. And for those that, Oliver actually is our new VP of IR, not that new now. He knows many of the investors that we have here as well. So he's joining us today. And thank you very much for having us. We had a very productive day.
Excellent.
Earlier.
Excellent. So, Shelley, I thought maybe you could take 20, 30 seconds and maybe a very high-level overview of the company, and then maybe also tell us kind of about the premium IOL market.
Okay.
You guys have had tremendous success in making inroads there. But help us think through where premium IOL penetration can go into the future, what's been driving your success, and if you could weave that into the description, that would be great.
Okay. Well, that's a good 45 minutes.
Yes.
No, what I would like to say is RxSight was founded about 20 years ago as Calhoun Vision. We changed our name about 6 years ago to RxSight. But it's a very difficult technology. There was a lot of patent protection. But the idea germinated with a doctor in San Francisco, and he was colleagues with a Nobel Prize chemist out of Caltech. And he actually developed the chemistry in our particular IOL. And their thought process then was the same as today. If you could adjust the IOL once it had been planted in the patient's eye post-cataract surgery to change the shape, and that change in shape would give a refractive change to the patient and reduce the need for glasses. So as we talk about the company, that's our overarching theme even today.
When we talk about competitive IOLs, we talk about what we call fixed IOLs. We're the only adjustable IOL on the market, first to market and well protected. With the history, you can imagine it was a difficult project.
Great. So just maybe taking it to the premium IOL market, where is your share currently? Where do you think your share and then presumably your expansion of the premium IOL segment of the broader IOL category? Where do you think you can take that?
Okay. That's a really good question. I'm going to focus on the U.S. market because that's where we've commercialized. Very typical for a company like ours to first commercialize in the U.S. The U.S. is actually the largest market worldwide, both for premium IOLs as well as the overall IOLs. So I'll talk about that a little bit. Although we are commercialized in Canada as well, it's a relatively small market. But the U.S. market has about 4.5 million cataract procedures per year. It's growing at 2%-3%. What is driving that growth is just the aging population because about 25% of the population in the U.S. is in our age category, which is 65 and older. They control about two-thirds of the wealth. Then when you think about the premium IOL market, it's segmented into about 1 million procedures that are expected in 2024.
There are around 900,000 in 2023. As you look at it, we talk about the premium market as being all the premium IOLs on the market. So if you look at the 4.5 million procedures and about 1 million premium, it's about 20% penetrated in the U.S. We think ultimately that could go to 30% or 35% penetrated. Some of the larger players have also said that. We believe it'll be driven by better results, more predictable results. We think we are a very large part of that with our adjustable IOL called the LAL. If you look at the market segmentation in the premium market, it is consisted of toric IOLs, and those are for astigmatism. Our product, which is adjustable, can do refractive change for both distance, intermediate, near, and astigmatism. That's done after the IOL is implanted in the eye.
And then the other fixed lenses in the market that are called EDOF lenses for extended depth of focus and multifocal lenses. If you look at the overall market within those, toric lenses, which are less expensive and less profitable for the doctors because they offer more limited value, represent a bit over 50% of the market. Then we estimate based upon annualizing our Q1 results with a bit over 21,000 eyes implanted that we represent about 10% of that premium market ourselves.
Got it. So within your installed base, if you kind of look at the cohorts of adopters, I'm sure there's the original class and kind of where they've gotten to, then the ones that are coming up the curve, more medium, intermediate adoption levels, and then the newbies, right? Could you talk to kind of what the utilization rates look like or what the penetration of the highest volume versus the medium and lowest volume looks like?
Okay. Yeah. And I think that kind of you asked a two-part question. What type of customers are we reaching today? Because there's about 10,000 cataract surgeons in the U.S., and about 4,000 of them do about 70% of the procedures today. And that's where we're focused. We have 732 LDDs sold in the U.S. primarily. And we're focused on the larger practices. But ultimately, we think that penetration should go into and the availability into all cataract surgeons as well. And so that's one way of looking at that size. The other way of looking at it is the adoption curve, which usually starts out with your technology adopters, your early adopters, kind of early mid adopters. We think we're just entering that range. And then, of course, you get the middle majority and then the laggards on that.
So we think we're just entering that portion of the market that we would call the early mid doctors and do that. That's a way of looking at kind of the penetration. It's really characterized by the way they look at new technology and adopt new technology. Then the third way of looking at it, which is something I have talked about before, is I look at our installed customers in 2020, 2021, 2022, 2023. We don't have enough data on 2024 yet. I look at the number of LALs per LDD per month, right? So we've increased it quite a bit and ended last quarter at about 10. What I see is all the classes end up at relatively the same position of LALs per LDD. They're all growing.
So to your question about how many can be done by one practice or one doctor, we don't know that top off yet in number of LALs per LDD. The other thing that is good about this data as far as we're concerned is the slope of the line is steeper in our 2022 and 2023 classes than in the early classes. And we think some of it is the sale of the product. We have more references than we had before. So a new doctor might go to a friend or colleague and say, "How is this working for you?" And the message is usually, "Get going as fast as you can." You don't want to just see one patient. You want to see the results for multiple patients.
That's going to give you really great early feedback on how successful this product is and the results and the happiness of your patients. We also think the other factor is, as we've commercialized, we've expanded our clinical force. We added an LAL sales force. We started about six months after we went public. And those people are responsible for helping the practice make that conversion, making sure they have all the digital tools that they want, brochures that they have those. They talk to the entire practice from the intake call all the way through the optometrist about how to sell the LAL and also how to arrange their practice to accommodate the LAL. They've been doing the same thing for 20 or 30 years. And so it's a little less work upfront.
There are maybe one or two more visits post-op as compared to the other products, but premium products. But the patients want those visits. That's what they're paying for is to get the adjustments as well. And so we talk to them about how to maximize your patient flow. And most of it's just queuing theory because the visits, the patient needs to have their eyes dilated before the LDD is used to reshape the LAL. And so it's just waiting time a little bit. And that's done with the tech. And then typically in most practices, the optometrist does the LDD procedure. And that makes sense because the optometrist has already counseled the patient and talked to the patient about what results they want. They've tried test lenses. It's the exact same thing they would do for a post-cataract patient that needs glasses.
Then all they do with the LDD is enter the patient's current prescription and where the patient wants to go. Then they get in front of the LDD. It takes about five or 10 minutes for both eyes. Then the patient goes home for a few days or whatever works for their schedule to make sure that the polymers are fully polymerized for that treatment. They can come back in. They can go backwards. They can go forwards. And about 80% of patients in our Phase 4 study for the LDD changed their mind during the adjustment period about what they wanted. Then after that, they get locked in. And we think with the kind of results.
Sorry, just what's the average number of adjustments?
It's been running about 1.6, which is the same as our PMA trial. Then, of course, they have two lock-ins.
Two lock-ins.
Two lock-ins.
Yep. Sorry.
What that does is it makes sure that all the unpolymerized components in the IOL are fully polymerized, and then the patient has their eyesight fixed for the rest of their life with the IOL. We have patient data from early data in Europe that goes back 10 years and shows stability in the product.
That's great. So where is the, I mean, you've had tremendous success, right? I think you grew 60% in the Q1 , thereabouts. Some of that's LDDs, but the big chunk of that's obviously LAL adoption. Where's the pushback or the resistance still either on getting greenfield accounts to convert or getting the current high volume or intermediate volume physician from advancing down the penetration curve?
Yeah. We always think this is the third technology that our CEO, Ron Kurtz, has brought to the market. The first two became standard. It took us a long time, over 50% of the volume in 10 years or more. So this is something we're familiar with, is breaking this kind of ground. But the objections kind of change as you get more mature. The first objection when we began selling the product was, "Well, I'm a superior surgeon. I can get the results that you had in your PMA trial myself," right? That drops away, particularly as we offer more data and other doctors are talking on the podium about the product. The second objection is you have to buy a piece of capital.
The switching costs between different products that are fixed IOLs is very low because they don't have a piece of capital, but also they can't adjust the IOL afterwards. So that's you have to right now, our ASP is around $130,000 for the LDD. It's not much higher than a piece of, say, equipment that's diagnostic in the doctor's office. We find that that has about a six-month payback for a doctor who's doing an average number of procedures, nine or 10 a month. So we've had that data, and it's been very consistent. Of course, the ROI has dropped, the number of months consistently. The third objection really is the status quo. That's always your biggest competitor. You're changing your patient flow a little bit. You're selling a little differently. It's a little easier.
You're not going to discuss the merits and demerits of what you have in trade-off. You're just going to say to the patient, "I'm going to implant an IOL in each eye. And after your eye heals two or three weeks later, I'm going to do an adjustment. And on both eyes, you're going to get to choose what type of vision you want." And that is something in terms of practice flow that's a little different for the practice because they have less testing upfront, but maybe not more visits, but more intense visits afterwards. And so they just have to think about patient flow. And that's something that our LAL sales force does with our customers in concert with our clinical teams who train on the LDD.
What about the LAL +? Remind me when you launched that, actually, and then how that's been faring in the marketplace. What are the advantages and feature sets? How should we think about that contributing to momentum?
Yeah. Thank you. The LAL + has always been embedded in our guidance. And we see the LAL and the LAL + sitting side by side. The LAL has a little bit extended depth of focus. But in the FDA trial, we showed that we didn't have a side effect of diminution of quality of vision, which is ability to see in low light. In fact, in our FDA trial, it was better than the monofocal lens, which is kind of the standard. The LAL + has a little bit additional extended depth of focus as compared to the LAL that we launched when we went commercial. And we see them sitting side by side. We charge the same price for them. We have done our full launch. We introduced it at AAO last fall and did a full launch at ASCRS in April. And that's fully available.
Doctors typically choose the LAL they think is best for the patient. So LAL + tends to be used for a patient that might want all distance but doesn't realize that and wants a little bit of close-up as well. The LAL + is nice for that. And then we see those patients kind of asking for a little bit more near because they've got both. And the LAL might be more ideal for somebody who's post-refractive patient where the cornea is significantly aberrated. And you're going to have some adjustments afterward as well. So we don't see one versus a bigger driver than the other. It's just another expansion in our product line. And we've had 36 PMA supplements since we got our initial approval. It's a pretty torrid pace.
It's significantly similar to what Ron drove in our previous two companies, is about continuous improvement. That's very important. We have a lot of things that we don't talk about a lot, but some things like LAL +, which are more visible to investors and to the marketplace.
Okay. But they're side by side. There's no price difference. I guess why wouldn't someone use the LAL+ ?
The LAL, we think, is going to be more ideal for a post-refractive patient. Their cornea is more aberrated, but they may have only been set for distance before. You wouldn't want to introduce, some people do monovision with the refractive surgery, but not everybody does. So most people are setting their eyesight for distance, and they want to keep it the same for those patients. Then they can introduce a bit of blended vision as you go forward.
Okay. So it's helping you address the population you weren't necessarily able to optimally address before.
No. It's just the LAL would be more the doctor might charge the take the LAL rather than the LAL + for post-refractive. The LAL +, of course, both of them are adjustable, so we can address the same patient population as well. The patient always determines the amount of near vision and blended vision. And about, I think it's 90% of patients that are in our Phase 4 study with over 1,000 patients bilaterally implanted end up doing some kind of blended vision.
Got it. Two areas of outperformance in recent quarters, the margin and the gross margin, and then LDDs and the ramp in the LDD installed base. I guess what can you say about how big we should be thinking about or how big this installed base could get over time in the US relative to the account opportunity? How should we think about that factoring into gross margin because I think they're linked? And how should we think about gross margin, operating margin on a longer-term basis?
Okay. So I'll start with the second part of your question. What's our opportunity in the U.S. with the LDD? And of course, we also have opportunity internationally. I think I said this before, of the 10,000 ophthalmologists that do cataract surgery in the U.S., about 4,000 do about 70% of the premium procedures. We see our market opportunity as every ophthalmologist. And ultimately, where we want to be is at 50% of the premium IOL market. And that takes a long time to get there, but we think it's realistic given the advantages of our product and that it can become accessible and easy to use for doctors who are maybe only doing toric, not doing much premium. They may be uncomfortable with not being able to deliver the results that the patient wants. And this gives them an opportunity to do that.
It's better medicine for the patient, right? But also, they're bringing a refractive procedure into their practice, which is patient-pay. That offsets all the Medicare cuts that they're getting as well. Then, kind of going into margin based on that, we've got two products. The Light Delivery Device, which is the piece of capital equipment. I said it sells for about $130,000 ASP. It's in the doctor's office, not in an ASC. That, when we were talking about the LDD post-COVID, where we saw these tremendous increases in prices for everything, particularly semiconductors, all kinds of chips. The LDD is primarily material cost. So we saw our vendors bringing up prices significantly. We kept the price of the LDD the same. Market penetration was a bit more.
We think about capital as wanting to have a margin of 20%-30% at the gross margin level. We think it's fair for us and fair for the customer as well. We were right about that 20% before we introduced our reconfigured LDD, very similar to what a lot of companies in capital equipment do. The parts become obsolete post the initial trial. That takes time. It's also an opportunity for us to take cost out, which we did. It's the same functionality, but while we took cost out mid-third quarter when we introduced the product, we also took about a 10% increase. So we're getting really nice margins right now above the 30%. It gives us opportunity to bring down the price if we need to later on. Kind of, capital tends to drip down. The LAL, of course, has excellent margins.
Gross margin is primarily driven in the last few quarters by the LDD being a little bit lower cost, higher price. Of course, what we saw in the Q1 is the power of mix because the LAL carries a much higher gross margin. In the razor razor blade model, you tend to get increasing margins because as the business grows, your LAL will become a bigger part of the revenue. We had 70% gross margin in the Q1 on 67% of our revenue coming from the LAL. We did guide 68%-70% because the mix is really determined by the percentage of LDDs and LAL sales in the year.
Yeah. But if you continue to have overage on the LAL kind of proportion, that should flow to gross margin upside.
It should. Yes.
We're getting close here to the end of the discussion, but you recently did a capital raise, and I want to touch on that. Can you talk to us about the expected uses for the proceeds, timing? Is that the last raise you guys think you might do, or is the incremental investment you reserve the right to come back as you need it?
So I'm going to answer the first part of your question first, and maybe not the second part. I'm trying to be a little humorous there. So we raised $115 million gross, about $108 million net in a CMPO. It was the second CMPO we did. We did one in February of 2023 as well. And the timing of the raise really was related to where we are in the business. We think we have enough visibility among ophthalmologists and a slight visibility among optometrists. And we want to use that money for several purposes. One is more education in the U.S. because we're always in the education business when you're introducing a new technology. Make it more widely known. Do more local shows because a lot of customers don't go to major shows. Spend more time with our doctors putting on symposiums for their reference network, which is optometrists.
Do some optometric shows. Be available, but probably not put in a booth because there are about 50,000 optometrists in the U.S., and they're a great source of referrals for doctors. So that's the first part. So more money in sales and marketing. We'll continue to invest a bit more in R&D. We have a real philosophy, as you can tell from our 36 PMA supplements since introduction, since our initial approval, that we have a philosophy of continued improvement in the product, and that drives adoption. And then, of course, we hope to enter the international markets when we get approvals.
Got it. And just have you put timing out there on international approvals?
We have not. Some of them are pretty long. Recently, Europe, which was pretty you go back a few years, you could kind of pretty much know when you were going to do it. But the notified bodies are quite behind because they're converting from the MDD to the MDR. So they've gotten backlogs. You can't really tell exactly when you're going to get your approval in Europe. Then, of course, there are really some good high-volume countries in Asia as well.
Great. Well, we're at the time marker here, but Shelley, Oliver, thank you very much. Really, really great session, and congrats on all the progress.
Okay. Thank you so much for having us.