2/28/2024

speaker
Operator

Good day, and thank you for standing by. Welcome to the RxSite fourth quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone, and then you will hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. Now, we'll hand the conference over to our speaker today, Oliver Moravchivich. Please go ahead.

speaker
Oliver Moravchivich

Oliver Moravchivich Thank you, operator. Presenting today are RxSight President and Chief Executive Officer Ron Kurtz and Chief Financial Officer Shelley Tunin. Earlier today, RxSight released financial results for the three months and a full year end of December 31st, 2023. A copy of the press release is available on the company's website. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflect management views as of today, February 28, 2024, and will include forward-looking and opinion statements, including predictions, estimates, plans, expectations, and other information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the Securities and Exchange Commission, or SEC. Our SEC filings can be found on our website or on the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding this non-GAAP financial measures, including reconciliations to the most comparable GAAP measures, can be found in the press release. Please note that this conference call will be available for audio replay on our investor website. With that, I will turn the call over to our President and CEO, Dr. Ron Kurtz. Ron?

speaker
Ron Kurtz

Good afternoon, and thank you for joining us. In a moment, Shelley will be giving an update on RxSight's financial performance for both Q4 and full year 2023. For context, I wanted to discuss key factors that we believe underlie the market success of the light-adjustable lens and can drive RxSight's performance over a sustained period. The eye care field is at the forefront of many of the change drivers in medicine, most notably reduced reimbursements to doctors and practices from third-party payers who are facing rising costs from an aging population. For ophthalmic practices, the major opportunity to offset these cuts began in 2005 when ophthalmologists were first able to charge patients directly for the additional costs associated with so-called premium intraocular lenses or IOLs that can reduce a person's dependence on glasses after cataract surgery. Growing from very low levels, premium cataract surgery now represents about 20% of the overall U.S. cataract market and about 10% of the global market. with premium procedures projected to double over the next 10 years. By providing anywhere from $1,500 to $5,000 in additional revenue per eye above and beyond the approximately $500 reimbursed by third-party payers, participation in the premium eye well market has become essential for ophthalmic practices to remain viable and continue to serve all their patients. Our sales efforts are concentrated on the roughly 4,000 U.S. cataract surgeons who perform 70 to 80% of all premium IOL procedures, though the percentage of premium cases varies widely from doctor to doctor and practice to practice. One reason for this variability lies in the challenging clinical requirements for a broadly successful premium cataract procedure, namely the ability to deliver consistent high-quality vision across a range of distances. With the commercial growth of the LAL and early introduction of LAL+, an increasing number of doctors recognize the power of adjustability to achieve this level of performance in a way that has not been possible with fixed optic non-adjustable intraocular lenses. With both the LAL and LAL+, doctors treat the actual refraction that is measured postoperatively, rather than trying to predict a result preoperatively for the first time achieving LASIK-level refractive results after cataract surgery. The LAL platform of lenses delivers equivalent quality of vision to the gold standard monofocal IOLs, something that may not be possible with multifocal eye wells that reduce contrast vision and increase rates of visual symptoms such as glare and halo. In fact, over the past 20 years, doctors have moved away from higher levels of multifocality, limiting the improvement in near vision for patients. In contrast, using the LAL platform, doctors and patients can customize vision in both eyes to optimize the quality of vision over a range of distances. We believe that by tapping into these fundamental market forces, the LAL enables doctors to meet the vision goals of more of their patients, as well as the financial goals of their practices. In turn, driving RxSight's superior performance in Q4 and full year 2023, as Shelley will now review.

speaker
Shelley

Thank you, Ron, and good afternoon, everyone. Consistent with our January pre-announcement, RxSight reported fourth quarter 2023 revenue of $28.6 million, up 78% compared to a year-ago quarter. Growth was broad-based, reflecting both the continued expansion of our installed base of light delivery devices and a sharp increase in LAL procedure volumes. The favorable trends we observed throughout 2023 continue to be driven by surgeons' growing recognition of the clinical and economic benefits provided by the RxSight system and the adjustability of our LAL technology. In the fourth quarter of 2023, we sold 77 LDDs, up 35% compared to the year-ago period. Fourth quarter 2023 LDD unit placements generated $10 million in revenue representing a 52% year-over-year growth. We ended 2023 with an LDD installed base of 666 units, up 67% compared to year-end 2022. LAL sales continue to rise in the fourth quarter of 2023, reflecting surgeons and patients' growing preference for the superior clinical performance of our adjustable IOLs. We sold 18,771 LALs in the period, up 98% from the fourth quarter of 2022. These procedure volumes translated into LAL revenue of $17.8 million in the fourth quarter of 2023, also up 98% compared to the year-ago quarter. Higher LAL volumes during the fourth quarter also contributed to an increase in the LAL revenue mix, with LAL revenue representing 62% of total revenue compared to 56% in the fourth quarter of 2022. This change in the mix, coupled with the sale of our LDD with a lower cost to manufacture and a higher average selling price, expanded our gross profit margin to 62% in the fourth quarter of 2023 compared to 46% for the fourth quarter of 2022. Fourth quarter SG&A expenses were $21.2 million, up 35% versus the prior year period. This year-over-year increase in SG&A was primarily associated with increased expenses in sales and clinical personnel costs to support our growing installed base as well as our first year of SOX implementation consulting and audit costs. On a sequential basis, SG&A was up 11%, primarily due to an increase in sales headcount and expenses related to the higher sales volume achieved in the fourth quarter. Research and development expenses for the fourth quarter of 2023 were $7.3 million, representing an increase of 10% year over year. The change versus a year-ago quarter was primarily due to increased headcount and associated increase in salaries and stock-based compensation. On a sequential basis, R&D expenses remained relatively stable with a 3% increase compared to the third quarter of 2023. We reported a net loss in the fourth quarter of $9.2 million or a loss of 26 cents per basic and diluted share using weighted average shares outstanding of 36 million shares. In the year-ago quarter, our net loss was $15.6 million, or 56 cents per share on a basic and diluted basis, using a weighted average of 28 million shares. Note also that stock-based compensation in the fourth quarter was $4.4 million, resulting in an adjusted net loss of $4.8 million or 13 cents per basic and diluted shares. In the interest of time, I'll provide a brief recap of full year 2023 results. Revenue grew 82%, $89.1 million, driven by a 43% and 117% increase in LDD and LAL revenue respectively. Our 2023 growth margin was 60% versus 44% in 2022. Total operating expenses were $103.9 million in 2023, representing an increase of 23% compared to operating expenses in 2022. For the full year of 2023, we reported a net loss of $48.6 million or $1.41 per share versus a net loss of $66.8 million or $2.41 per share on a basic and diluted basis in 2022, excluding $15.7 million in stock-based compensation expense and $1.8 million in loss on the full extinguishment of our term loan in 2023, adjusted net loss was $31.1 million or 90 cents per basic and diluted shares. Moving to the balance sheet, we ended the year with no debt and $127.2 million in cash, cash equivalents, and short-term investments. During 2023, we raised $95.2 million net of fees and expenses from our at-the-market program and confidentially marketed public offering and paid off our $40 million term loan in full. Adjusted cash use from operations was $33.9 million in 2023, down for $59.5 million in 2022. Finally, in our first year as a large accelerated filer, we are proud to report that we had no material weaknesses or significant deficiencies in our SOX compliance underscoring our commitment to financial integrity and operational excellence. Turning to the 2024 guidance, consistent with the guidance we provided in January of this year, we continue to expect 2024 full-year revenue to be in the range of $128 to $135 million, implying year-over-year growth of 44 to 52%. we expect to see overall quarterly sequential growth with seasonality expected in the first and third quarters. Typically, the first quarter tends to be softer sequentially for capital equipment, in our case, the LDD, with continued sequential growth in LAL procedures, but lower sequential growth than the seasonally strongest quarters, which are the second and fourth quarters. We expect our gross margin to expand to a range of 65% to 67%, reflecting a continued increase in revenue mix from higher margin LAL procedure volumes, as well as gross margin benefit from our LDD with a higher ASP and lower cost to manufacture. We continue to expect operating expenses to be between $125 million and $128 million which represents an increase of 20 to 23% over the prior year and reflects ongoing investments we're making to establish a large and durable postoperative light treatment infrastructure to support sustained LAL procedure growth. Included in our cost, primarily in operating expense, is non-cash stock-based compensation expense of approximately $22 million to $25 million. Before I turn the call back to Ron, I am pleased to announce in conjunction with this year's ASCRS meeting, we will be hosting an investor event on April 6th at 7 a.m. Eastern Time. Please stay tuned for more details from our investor relations team as the event date approaches. With that, I'll turn the call back to Ron.

speaker
Ron Kurtz

Thank you, Shelley. While we are pleased with the strong finish to 2023, we're also thrilled about the journey ahead. We're particularly inspired by the opportunity to achieve our ambitious goals, which will leverage the immense talent and creativity of both the RxSight team and our clinical partners. Like any new clinical capability, adjustability requires both a financial and intellectual investment. But as I noted earlier, the benefits to patients and practices are clear. As we celebrate the 75th anniversary of the intraocular lens in 2024, it's essential to recognize the eye care community's investments in innovation. This commitment has ushered in advancements from which we all benefit today, highlighting the importance of adopting change over maintaining the comfort of the status quo. We look forward to highlighting this mutual commitment to continued innovation at the 50th anniversary meeting of the American Society of Cataract and Refractive Surgery in Boston in April, when our clinical partners will present more data on the latest advances in adjustable IOL technology and practice. With that, I'll ask the operator to open the call for questions.

speaker
Operator

Thank you. At this time, we will conduct a question and answer session. And as a reminder, to ask a question, you'll need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your questions, type star 1-1 again. please stand by while we compile the Q&A roster. First question comes from the line of Steve Lichtman of Oppenheimer. Go ahead.

speaker
Steve Lichtman

Thank you. Good evening, guys. So just a few questions. First of all, on LAL+, given its ability to provide more near vision out of the box, do you see it as a door opener for surgeons who are who perhaps in the past would not have looked at LAL?

speaker
Ron Kurtz

Well, Stuart, thanks for the question. You know, I think it's important to note, as we've presented and our doctors have presented at various meetings, that the LAL itself provides great distance and near vision. And so we're starting from a very high level. The LAL Plus does provide earlier return of near vision. And so doctors now have, you know, two adjustable tools and over time will decide how they're going to use them. I think that, you know, for any doctor who for whatever reason hasn't adopted adjustable technology yet, it's certainly another reason for them to adopt the technology and make this available to their patients.

speaker
Steve Lichtman

Great. Shelley, how should we think about the relative growth of LDD sales versus LAL sales in your 24 guidance?

speaker
Shelley

Yeah, well, we don't break out in our guidance the quantity of LALs and LDDs. I think what you've seen in the last several years is LAL revenue goes up faster than LDD revenue. And of course, that's just a natural evolution of a razor razor blade model. And that's very consistent with how we have performed. And it's really because of two reasons. One is, of course, we're adding new customers with sales of the LDD. as well as the fact that part of our impetus for growth is to get further embedded in each one of our existing accounts and increase their usage. So normalized, we would expect, just like we saw last year, that LAL revenue will accelerate faster than LDD revenue.

speaker
Steve Lichtman

Okay, got it. Just lastly for now, you're guiding to sales growth in 2024, obviously well above OpEx growth. What are you assuming in terms of growth of the customer-facing Salesforce? Are you growing the Salesforce on either the LAL or LDD side this year?

speaker
Shelley

We expect the LDD Salesforce to remain relatively stable. Maybe we would add one or so, but our territories are well covered by existing Salesforce, which numbers about 20. On the LAL Salesforce, we add some, and this is really just dependent on depending on how their territories evolve, how many existing customers they have to support, but we'll continue to add. people, but not at a torrid place like we did when we initially created the sales force. Where we tend to add the most people is in our clinical sales force. And those folks are responsible for training doctors, both in the OR on use of our injector. Every IOL manufacturer has one that's a little bit different. as well as techs in the OR. They tend to have pretty high turnover sometimes in some ASCs. And then also they train on the use of the LDD both for the doctor, the optometrist, and often for technicians. And they partner a lot with our LAL sales force to bring up procedure volumes in our existing customers. But that's where you'll tend to see the most additions in sales and marketing.

speaker
Steve Lichtman

That's helpful. Thanks, Ryan and Shelley, and congratulations on the quarter. Thank you.

speaker
Operator

I can't do one moment for our next question. Our next question comes from the line of Robbie Marcus with J.P. Morgan. Your line is now open.

speaker
spk07

Oh, great. Thanks for taking the questions. Congrats on a nice quarter again. Thank you. Maybe to start, you're getting of a fairly significant size, and one of your competitors missed the consensus IOL numbers today. I guess the question is really, at what point do you think doctors are starting to make the decision whether to go with RxSight versus other competitors that may have a bigger bundle because of the better clinical and selling benefits of the LAL.

speaker
Ron Kurtz

Thank you for the question, Robby. I think doctors always want to do what's best for their patients. Fundamentally, that's their intent. They want a happy patient, both for selfish reasons, but also just quality of their own lives. they're really motivated to deliver the best clinical results possible. and they're going to make their decisions based on that. So our focus is really providing, one, providing the best clinical results, but then presenting to doctors and practices that haven't yet adopted the LAL that data and that information so that they can make their own decisions and be confident in what they're offering. I think that it's not necessarily an either-or decision. It's more of a decision of them making the choice to be able to offer this technology to their patients.

speaker
Shelley

Ravi, I'd also like to add that in our latest customer survey that we had a third party conduct, and the results are very similar to the previous two years. About 44% of Patients, as reported by our doctors, would not have gotten anything other than a monofocal lens. So in that case, we're growing our practice, and in theory, you know, growing market. We're still very small. And then the balance comes from toric lenses and other PCI-OLs. So I think it's good to know that, you know, about 66% of the volume is coming from other alternatives that might have been taken about, you know, most of those from toric lenses where they're upselling, but a significant amount from PCIOLs as well.

speaker
spk07

Great. Really helpful. And maybe one just on balance sheet and cash usage. You still have a pretty healthy cash balance right now. You're burning cash, though. I imagine that'll continue to decrease cash usage as you continue to grow here. But how are you thinking about your positioning and the potential to reach cash flow breakeven? Thanks a lot.

speaker
Shelley

Thank you. You know, we have said previously that we'll continue to reduce our cash use throughout 2024 as compared to 2023. and also to expect that cash use is heaviest in the first quarter just because we pay year-end bonuses and we get material in and those things get paid in January. But you should see decreases throughout the year. We have also said and we continue to say that we have adequate cash to get to cash flow break even with a healthy balance sheet.

speaker
spk07

Very clear. I appreciate it. Thank you.

speaker
Shelley

Thank you.

speaker
Operator

All right. Thank you. One moment for our next question. The next question comes from the line of Larry Bigelson. Your line is now open.

speaker
Larry Bigelson

Hey, guys. Thanks for taking the questions. This is Simran on for Larry. I just wanted to start off on your 2024 outlook. I know you're not providing LAL versus LDD mix explicitly, but how are you thinking about LDD utilization in 2024? We're conservatively forecasting a small step down, but any reason utilization can't grow year over year?

speaker
Shelley

Yeah, I think that utilization is a nice metric just in that anybody can calculate it. But it will vary throughout the year. Because we calculated as the number of LALs implanted in a quarter divided by the LDD install base in the previous quarter, if you have a very heavy LDD placement quarter in a seasonal quarter for LALs, you might see a little bit of a step down. But overall, our goal is to increase that. But if we get very high LDD sales, that can mute it a little bit. While we don't guide on that, as I mentioned to Steve's question, that we expect LAL revenue to grow faster than LDD revenue.

speaker
Larry Bigelson

Great. Thank you. And just to clarify on the phasing of sales throughout the year, it sounds like we should expect sequential growth quarter over quarter throughout 2024, including Q1?

speaker
Shelley

You know, what we did guide is to sequential growth with seasonality. And where we said specifically that we would expect continued sequential growth despite seasonality in our LAL revenue.

speaker
Larry Bigelson

Okay, perfect. And just in terms of your international business, How has the launch in Canada been progressing relative to your expectations? And will there be any contribution from new geographies in 2024?

speaker
Ron Kurtz

So Canada has gone very well. We're very pleased with the rollout in Canada. And that continues to go well. I think it's... you know, a good marker for, you know, the importance that international will play over time. And we're certainly considering, you know, other markets that we think will be particularly attractive to the LAL. And we'll be talking more about those as the year progresses.

speaker
Larry Bigelson

Great. Thank you.

speaker
Operator

All right, thank you. One moment for our next question. This question comes from the line of Ryan Zimmerman, BTIG.

speaker
Ryan Zimmerman

Hey, good afternoon. Thanks for taking the question. Congrats on a strong year. I want to just start first with The LDD, the capital sales force, and you guys are leaving that sales force unchanged. Is there a point at which you reach kind of a peak sales rate per quarter in terms of LDD units just based on simply capacity, even if the demand is there? And where are we at relative to maybe a peak capacity, in your view, from the LDD sales force?

speaker
Shelley

Yeah, I think that, you know, as we look at the LDD Salesforce, you know, these folks have developed a territory now. As you know, they typically start with their highest volume customers, customers that they know better. But, you know, their efforts are really enhanced by our marketing efforts, the ability to get out to shows. We do about 80 tabletop shows a year. And out in the tip in the territories and also they couple the la salesforce new accounts, as well as potential new accounts and so. You know we'll add people if we see it's necessary, but typically with couple equipment people you kind of get the opposite effect if you cut down their territory. because they've already put the money in and that doesn't work real well. But we'll always keep that ahead of ourselves. But we don't think like doubling the sales force just automatically doubles the placements. I think just continued market acceptance and knowledge about the LDD and them talking to peers, both at shows and one-on-one, starts to – we've seen that momentum build through the last several years.

speaker
Ron Kurtz

Yeah, and just to reiterate with Kelly – I'm sorry, Ryan. I was just going to reiterate, you know, the LAL account team has grown, and they are, you know, involved with capital equipment sales as well to a lesser degree, but they do receive part of their compensation from that. Okay.

speaker
Ryan Zimmerman

And then second question for you, Ron, you know, bigger picture, you know, when we think about the growth of the premiums segment here, you know, you talked about kind of where we're at today, you know, maybe 20% in the U.S., 10% globally, and the expectations are that that goes, you know, to 2x. When you think about those market forces that you talked about, I mean, is there any reason to think that, you know, that cadence from, you know, A to B is is not evenly distributed over the next, call it, five to ten years. Is there anything in your mind that accelerates it or maybe hockey sticks it, if you will, on the later half of that time frame? Just trying to think about kind of the broader adoption in the premium segment here as you guys continue to grow.

speaker
Ron Kurtz

Well, I mean, obviously, we hope to be part of that driver by providing clinicians with tools that they can use to, you know, give their patients high-quality vision with very high consistency. And so, you know, I think that that has been a factor in holding back not all clinicians, but a number of clinicians from participating more widely in this market. Also, you know, it's an important component of our technology is that it involves optometry in a very meaningful way. And they are a huge part of the eye care community that you know, up to now has had a relatively minor role in premium cataract surgery. So I think that those two factors are ones that will help to drive the overall market and obviously fuel our growth as well.

speaker
Ryan Zimmerman

Understood. Thank you.

speaker
Operator

All right. Thank you. One moment for our next question. Next question is from the line of Craig Bijoux of Bank of America. Please go ahead.

speaker
Craig Bijoux

Good afternoon, guys. Thanks for taking the questions. So just wanted to ask on maybe some utilization trends at the individual practices. I know you guys have talked about seeing adoption, maybe faster adoption with the newer surgeons faster utilization relative to some of the surgeons that were added a couple of years ago. So what I wanted to know, you know, is that still kind of what you're seeing? Is that what you expect for 24? And maybe just, you know, color from you on why you do think that's the case, why, you know, a newer adopter is going to move faster or ramp faster with the LALs.

speaker
Ron Kurtz

Thanks for the question, Craig. I think, you know, maybe I'll take the broader question and ask Shelly to pontificate more about the future. But the, you know, it's not, you know, it's kind of understandable that as time goes on, two things happen. One, we get better at, you know, initiating customers. We have, you know, we've learned our processes. We've refined our processes. They have, you know, the customers themselves have experienced vicariously through their friends and competitors the LAL experience. And so they, it's just a, you know, better process for them. The second is, I think, a little bit the characteristic of people who are adopting, you know, not at the initial rollout but a little bit later, still early, but a little bit later in the process. And, you know, those people, as you typically see in an adoption curve, tend to be a little bit more – thoughtful about what they're trying to achieve. They're more focused on getting an ROI, you know, as soon as possible. Obviously, and so they're more likely to, once they are convinced of the value of the technology, to implement that a little bit more quickly.

speaker
Shelley

Yeah, the only thing I would add is that our goal is to become standard of care. And the first place we need to become standard of care is inside of each individual account. And other than a few customers, we haven't gotten there yet. And that's why it's so important for us to continue to penetrate our existing customers. And we're just not at that level yet. And so that is a major problem. for our LAL salespeople and our clinical personnel as well. So we would expect, and it's certainly our goal, to continue to get further penetrated in each account.

speaker
Craig Bijoux

And thank you, guys. And maybe just a follow-up on that. When you think about an individual practice, are you guys, you know, obviously it's Shelly, you just mentioned it's not standard of care yet or only with a few practices. But what is that percentage of penetration? Is that trending above the 20% of the broader market for premium? Maybe just a little bit of color on how you see an individual practice evolving in terms of percentage of IOLs that they're using LALs for.

speaker
Shelley

You know, I think that that's voice of customer. And I have to tell you that is not information that we ask customers on quarterly or even an annual basis. What we do look at is trends by account and trends by doctor. And so our clinical and account managers, which are our LAL personnel, look at each one of the accounts that they're responsible for. on a weekly and monthly basis. And if they see something up or down, they're going to, you know, talk to the practice. If they're down, maybe a doctor's on vacation. If they're up, you know, they'll try and find out, you know, what's driving it? What can we do to continue to drive it for you? So we really, you know, go bottoms up in the accounts. But we do know overall, if we talk to a particular customer, that they'll say to us if they're very heavily penetrated, hey, I'm using you for 50% of my premium cases or I'm using you for 80. Other people aren't saying that yet. So I would say mostly it's anecdotal overall. Ron, would you add anything to that?

speaker
Ron Kurtz

The only thing I would add is that, and it goes to the previous question, question, I think, a little bit is that, you know, overall, while the earlier customers may be getting up to speed more quickly, all of our customer cohorts are continuing to grow. And, you know, that's driven by all the factors that we've already discussed, the, you know, realizing that the technology can also provide excellent range of vision and extending it into that realm of their practices as well. So I think it's adding additional doctors within the practice once the infrastructure is there to support them. So there are just a number of factors that help to drive adoption within a practice. And our team is looking at all of those, both the internal team and, of course, you know, the R&D team here as well.

speaker
Craig Bijoux

Great. Thanks for taking the questions.

speaker
Operator

Thank you. One moment for our next question. Next question comes from the line of Patrick and Stanley. Your line is now open. Amazing.

speaker
Stanley

Thank you. Just two quick ones from me. Maybe to jump off on the kind of the health of the customer and the practice side of things. I mean, I guess U.S. refractive is probably down 20% in Q4. You know, trifocal and EDOF has been a little sluggish as a market. How much more opportunity is there for you today given, you know, to a point you're still additive to a practice given 44% or so going from monofocal to LAL? How much more of an opportunity is there to help the practices improve their economics given the environment seems a little trickier than it has been in the past.

speaker
Ron Kurtz

Well, thanks for the question, Patrick. I think that we always have to remember that the market is complex in private pay, and we don't want to conflate the refractive, the corneal refractive markets that are generally a younger population, much more sensitive to overall economic factors, than the patients who are the demographic for our technology, which quite frankly have done quite well over the last five years You know, probably, you know, they're sitting on the bulk of the wealth in our country. So I think that, you know, that potential is still very strong. And the underlying desire of, you know, patients in that demographic to maintain their, you know, functionality, their ability to participate in work and leisure activities at the same levels, through great eyesight and without glasses, that's a durable trend. And that demographic, of course, is growing as the population ages. So, you know, I think that while the PC IOL market may have, you know, we might have seen or some people have reported a flattening of that, the overall premium market continues to grow. Obviously, we're a part of that. But, you know, the TORIC market continues to grow. And I think both of those are indicative of this drive to quality of vision. And we can't underestimate that, that, you know, patients really do value quality of vision.

speaker
Stanley

That's helpful. I guess I meant more that the clinics themselves have been losing some of the patients on the refractive side and a little bit more selectors on the other side, and therefore you can help them with that because your business is obviously additive to them. I guess I was coming at it more from the clinic angle.

speaker
Ron Kurtz

Yeah, absolutely. I mean, I think that's an argument that our sales force is making, that as the, you know, as the corneal refractive business goes up and down, ebbs and flows with the economy, certainly focusing on the premium IOL business, particularly one that provides a high-quality vision, is a much better long-term investment. That's super helpful.

speaker
Stanley

Then follow on I know it must be hard for you guys to get this kind of data, but do you have any sense for how often you're getting bilateral implantation? Because obviously for some patients, monovision, if they're not familiar with it, can be a good and sometimes it can be a bad fit. Do you know how often you're getting implanted, say, with an EDOF or a trifocal simultaneously?

speaker
Ron Kurtz

I think that that's pretty unusual. We don't have firm numbers, but when we... You know, we do have a large data registry, which has over, last time it was reported on, it was over 800 subjects. And in those patients, about 90% were bilateral. So, LAL, bilateral LAL. And, you know, presumably some of those, some of the residual patients either only had monocular cataract, which is certainly possible, or they had previous cataract surgery in one eye, possibly with a monofocal IOL or with a different premium IOL. You're beginning to see some talks from doctors which are talking about using the LAL with a you know, with perhaps a PCIOL. But, you know, I think with the addition of LAL+, that's probably going to be less important. You're powerful. Thank you for taking the questions.

speaker
Operator

Thank you. One moment for our next question. Next question comes from the line of Tom Stefan of Stiefel. Please go ahead.

speaker
Tom Stefan

Great. Hey, guys, thanks for taking the questions. First one on LAL Plus for me. Ron, I guess over time or once the full LAL Plus launch is in motion, is there a way we should be thinking about the split between legacy LAL and LAL Plus? I guess just trying to get a better sense for what level of impact you anticipate LAL Plus having on the business relative to the legacy lens, and then I have a follow-up.

speaker
Ron

Well, you know, obviously we want to have a positive impact.

speaker
Ron Kurtz

We wouldn't have introduced it, but the, you know, I think that, you know, I think people have recognized or increasingly recognized that the LAL delivers exceptionally high-quality vision and can be used with a blended vision approach to provide a range of vision, and that works really well. You know, we see, again, in our registry data that Approximately 90% of patients are seeing 20-20 at distance and able to read J2 at near, which is about a five-point font, so it's the size of a footnote on a page. So I think that that's a great solution. To the extent that doctors felt that, gee, they wanted to have more immediate near vision, and they might have not considered an LAL in a particular patient, I think the LAL Plus is going to give them additional motivation to get the benefits of adjustability. And there are a lot of them, as we've talked about.

speaker
Shelley

The other thing I'd point out is both the LAL and the LAL+, which we really just call our LAL platform, are both priced at $1,000 per IOL. And so we wouldn't see any mixed change due to pricing.

speaker
Ron Kurtz

And the intent there is that we want the doctor and the patient to choose the best LAL for their case.

speaker
Tom Stefan

Perfect. That makes sense. And then quicker follow-up to shifting gears, just on Europe, Ron, could you maybe compare and contrast the U.S. and European markets, just as we try to think about your ramp in the U.S. in the context of, I guess, what's to come in Europe down the line? Maybe if you could talk to the competitive landscape, regulatory, any other key factors. Thanks.

speaker
Ron

Hi. Well, I think that it's always hard to generalize about a whole continent.

speaker
Ron Kurtz

There are a number of countries in Europe, and each one has individual market characteristics. So we don't necessarily look at it as Europe. We look at it as specific markets within Europe. They do, for the most part, share a regulatory framework. process, which has gotten more complicated, especially over the last year or so. But overall, it's a large market, a wealthy market, and ultimately patients are driven by the same motivations as they are everywhere else. They want to have high-quality vision. and excellent range of vision. And I think that, you know, ultimately, there'll be a number of very attractive markets for the LAL.

speaker
spk02

That's great. Thanks again.

speaker
Operator

All right. Thank you. One moment for our next question. All right, our final question comes from the line of David Saxon of Needham and Company. Your line is now open.

speaker
David Saxon

Great. Good afternoon, Ron and Shelley. Thanks for taking my questions. Apologies if any of these have been asked. Shelley, maybe I'll start with you. I know we talked about patents a couple months ago. You have a couple expiring in 26, I believe. But can you remind us what those ones are and then when the kind of quote unquote key patents expire and generally how you feel about the IP portfolio. And then I'll have a quick couple of follow-ups.

speaker
Shelley

Yeah, I'm going to have Ron answer that question.

speaker
Ron Kurtz

Hey, David. So, you know, I don't know that I would identify any specific patent as a key patent. We've got a very large patent portfolio that we've expanded over the years as we continue to develop and further develop this technology. As things come off patent, there's a whole slew of things that replaces them. Underlying your question, I think, though, is an assumption that IP is a you know, is somehow critical for us. And I don't want to minimize the importance of intellectual property. Of course, we take it very seriously, and we have an excellent program to maintain and expand our portfolio. But, you know, there are a number of barriers to entry to this technology, and I wouldn't put IP at the top of it. The number one barrier is this is just technically really hard to do. To adjust a lens after it's been implanted in the human body with the precision of making glasses is really difficult. And I think that it took us a long time to do it. I wish anybody luck to try to, in their quest, to do it as well. And then, obviously, over the last several years, we've built a commercial footprint, which we're expanding. And with that comes a whole education of the field and a building of expectation on the part of clinicians as to what what does adjustability, what are the measures of adjustability, what are the requirements for adjustability, and we keep advancing those. And that same process, of course, is going on on the regulatory front where we continue to move the technology forward and thereby educate the regulators. And so there are just several layers of barriers.

speaker
David Saxon

Okay, perfect. Thanks for that, Ron. And then a couple for probably Shelley. Gross margin was kind of flat sequentially. So can you help us with the drivers there? I think Mix was better in the fourth quarter. So anything there. And then on international, have you talked about what percent of revenue is coming from international and then what pricing is in Canada, Mexico, and Germany? Thanks so much.

speaker
Shelley

Okay, good. Thank you very much. Yeah, our mix between LAL and LDD in the third and the fourth quarter was very similar, and therefore also our gross margin was similar. I think what you were perhaps intimating is that you would hope we'd have a little bit more increase in gross margin from the fact that we were selling the LDD with the higher ASP and lower costs throughout the entire fourth quarter. And I just have to say, and I think we've talked about this before, is that there are always period costs. And those period costs, particularly on the LAL, are things like the consumption and the ordering of glasses and cartridges and other accessories from customers. They're not a one-for-one relationship. and we don't charge separately for those, as well as just period costs for things like inventory reserves and things like that, both on the LAL and LDD side. Scrap on the LDD, it just depends quarter to quarter. So the period costs tend to have a minor impact on margin, but they can vary quarter by quarter, and we saw a little of that in the fourth quarter, but that's quite usual. And then I think your next question was, what percent of revenue are we getting from international? And that would just be Canada in our case. And no, we don't break it out. It remains relatively steady in terms of their contribution on a quarterly basis, but growing throughout 2023. but it's not significant relative to the overall, but it's a great market for us. And then I think your third question was pricing in Canada. And we do use the distributors. That changes our ASP internally a little bit, but again, it's not predominant in terms of our overall LDD volume and LAL volume. But the absolute pricing to the end user customer in Canada is a bit higher than it is in the U.S. One, they're in an earlier stage of adoption, but more often they do expect to pay more just because of product introductions, lower volume, things like that.

speaker
David Saxon

Okay, great. Thank you so much.

speaker
Shelley

Thank you.

speaker
Operator

All right, thank you. This concludes the question and answer session. I would now like to turn it to Ron Kurtz, CEO, for closing remarks.

speaker
Ron Kurtz

Thank you for your time and attention today. We appreciate your interest in RxSight and look forward to updating you on our progress in future quarters. Goodbye.

speaker
Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Disclaimer

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