RXST (2025 - Q1)

Thank you for standing by, and welcome to the RxSight conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be question-and-answer session. [Operator Instructions] I would now like to turn the call over to Oliver Moravcevic, VP of Investor Relations. Please go ahead. Oliver M

Thank you, operator. Presenting today are RxSight President and Chief Executive Officer, Dr. Ron Kurtz; and Chief Financial Officer, Shelley Thunen. Yesterday evening, RxSight released preliminary revenue results for the 3 months ending March 31, 2025, and revised full year guidance. 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 questions during today's call reflect management's views as of today, April 3, 2025, 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 yesterday and in our filings with the Securities and Exchange Commission, or SEC. Our SEC filings can be found on our website or the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements, and we disclaim any obligation to update or revise these forward-looking statements, except as may be required by law. During today's call, we will also discuss certain non-GAAP financial measures. I would also like to remind you that the preliminary results discussed on the call today are estimates and our complete unaudited financial results for the first quarter of 2025, which are subject to the review of our independent auditor, are expected to be announced on Wednesday, May 7, 2025. Please note that this conference call will be available for audio replay on our Investor Relations website. With that, I will turn the call over to our President and Chief Executive Officer, Dr. Ron Kurtz. Ron?

Good morning, and thank you for joining us. I want to first recognize the entire RxSight team as well as our partners in clinical practice for all of their efforts to provide high-quality customized vision to patients undergoing cataract surgery. During today's call, we will be offering additional color on the factors that affected Q1 revenue and have led us to revise our 2025 guidance. We will also outline additional actions we are taking to reinvigorate our growth trajectory. Our preliminary analysis indicates that the top line miss in Q1 was due to several factors, including a weakened premium IOL market and unusual sequential launches of new premium IOLs that have extended from mid-2024 and into Q1 of 2025. These factors subsequently combined with abrupt changes in consumer sentiment that occurred later in Q1, resulting in our first year-over-year drop in same-store LAL sales, most commonly measured as LALs per LDD per month. During most of 2024, this metric saw strong year-over-year increases, which, along with new LDD placements resulted in high year-over-year procedural growth rates. Since nearly half of LAL procedures come from patients who would have otherwise received a standard monofocal IOL, when volume from the LAL is excluded, the remaining premium IOL market would have likely seen declines beginning in mid-2024. Due to the older demographic and medical necessity associated with cataracts, premium IOL surgery has historically been less sensitive to macroeconomic trends. This is in contrast to other patient paid procedures like LASIK that target younger individuals who can usually delay procedures indefinitely by continuing to wear their glasses or contact lenses. However, a softening of the overall premium IOL market in the second half of 2024 would be consistent with reports of a much more markedly depressed U.S. LASIK market during this period. While LALs per LDD per month also decelerated in Q4 2024, they remain near their earlier highs, leading us to underappreciate the likely downward trend in the overall premium market. This phenomenon likely also led us to underestimate the impact from sequential market launches of new premium IOLs by 2 major competitors in Q3 and Q4 of 2024. Historically, presbyopia-correcting IOL market share dynamics have been temporarily disrupted by incentives to surgeons trialing newly launched lenses. While typically transitory, the sequential product cycles continued to be a market distraction in Q1, which, when coupled with a soft overall premium market, likely provided less reserve for additional disruptions. Although small sequential declines in LALs per LDD per month were observed from Q4 to Q1 in both 2023 and 2024, we saw a much more pronounced decline from Q4 2024 to Q1 of 2025. While procedure volumes were consistent with our recent history in early and mid-Q1, lower procedure volumes extended through the month of March when they have historically ramped up. Given the widely reported and rapid changes in the macro environment, including significant declines in the S&P and NASDAQ during the latter part of the quarter, we believe that negative wealth effects may have impacted premium IOL procedure decision-making, leading to potential trade downs to lower-priced or non-premium alternatives. Though we believe these factors are also likely transitory, when coupled with a third sequential product cycle from our largest competitor, they justify a swift and strong response on our part. This starts with leveraging our dedicated commercial and clinical teams to execute refined clinical education and practice adoption programs for both existing and new customers, focusing on those that have experienced procedural declines or slower growth in the first quarter of 2025. We have also accumulated extensive clinical data and experience with both the LAL and LAL+ that we believe will help doctors better counsel patients on the durable benefits of high-quality customized vision that is uniquely enabled by RxSight's adjustable IOL platform. As an example, our recently completed post-approval study demonstrated that compared to eyes receiving a monofocal IOL, eyes with an LAL were 14x more likely to have what is considered to be an outstanding refractive outcome. Further, our continued rollout of product enhancements provides our teams additional opportunities for meaningful interactions with our doctors and clinical practices to convey their important clinical and efficiency benefits. In addition to these efforts with our traditional customers, we also intend to strongly support the acceleration in new customer business models including those that offer doctors and patients centralized third-party light treatment options that may further lower the threshold to adopt our technology. Though our focus remains on expanding adoption within the U.S. market, we are also pleased to report European regulatory approval for our LDD and LAL. While we are excited about the long-term commercial opportunity in the EU, our priority in 2025 will be to build a base of European clinical expertise and practice experience, while we also push ahead with approval of LAL+. We are simultaneously pursuing our regulatory approvals in Asia while gaining early clinical experience in Japan, Hong Kong and South Korea. While we remain highly confident in our long-term opportunity to reshape the premium IOL market, we also acknowledge the need to reset our 2025 guidance due to the time that may be required for these efforts to have meaningful impact and for the headwinds discussed earlier to subside. For more on these changes, I'll now turn the call over to Shelley.

Thank you, Ron. I will briefly review the preliminary first quarter revenue results and updated guidance for the remainder of 2025 that were included in our pre-announcement press release. Consistent with the press release, our preliminary first quarter 2025 revenue was $37.9 million, up 28% compared to the year ago quarter and down sequentially 6% from our fourth quarter 2024 revenue. During the first quarter, we sold 73 LDD's, up 11% from the year ago period and down 12% from the fourth quarter of 2024. We ended the first quarter with an LDD installed base of 1,044 units, up 43% compared to the end of the first quarter of 2024 and 8% compared to the end of the fourth quarter of 2024. We also sold 27,579 LALs in the period, up 36% from the first quarter of 2024 and sequentially down 5% from the seasonally stronger fourth quarter of 2024. While we will provide a full financial report on May 7, based on the preliminary revenue results and informed by the multiple dynamics just discussed by Ron, we are revising the guidance we provided in January as follows: we are reducing revenue guidance from $185 million to $197 million to $160 million to $175 million, thereby reducing implied growth compared to 2024 from the previous 32% to 41% range to 14% to 25%. We continue to believe that we will sell more LDDs in 2025 than in 2024 with economic headwinds likely having a greater impact on LAL procedures that are more directly tied to consumer decision-making. In contrast, as demonstrated by the relatively stable LDD sales in Q1, doctors and practices continue to invest in private pay procedures that deliver better outcomes for their patients and counteract ongoing reimbursement cuts and drive similar economically impacted private pay procedures such as LASIK. Our gross margin guidance is unchanged at 71% to 73%, representing an implied increase of 30 basis points to 130 basis points compared to 2024. We also remain committed to aligning operating expenses with the pace of revenue growth with a significant reduction in operating expense from the previous guidance of $165 million to $170 million to $150 million to $160 million, representing a change in the implied increase compared to 2024 from 22% to 25% to 10% to 18%. Our revised operating guidance of $150 million to $160 million is higher as a percentage of revenue and gross margin than our previous guidance in January, taking into account the anticipated increase in one-on-one interactions with customers. Included in our costs, primarily in operating expense is noncash stock-based compensation expense which we now project to increase from the previous $22 million to $25 million to $27 million to $30 million. This revision reflects higher-than-anticipated option grants issued in March 2025 to existing employees for performance, adjustment to market comps and retention compared to our original guidance provided in early January 2025. And with that, I'll turn the call back to Ron.

Thank you, Shelley. With customer satisfaction at an all-time high of 97%, we believe that RxSight's adjustable technology will continue to reshape the premium cataract surgery market by offering the only IOL that allows patients to customize their vision after surgery. By delivering exceptional clinical outcomes in one of the most important markets in ophthalmology, we believe RxSight remains central to the growth story for both ophthalmic practices and the overall IOL industry. While our large customer base now exposes us more to market-wide dynamics, we believe it also provides us with the opportunity to leverage our platform for sustained growth through targeted educational efforts and innovative product enhancements. In addition, we believe new clinical delivery channels offer alternative opportunities for growth in the U.S. while we continue to make progress towards commercialization in key markets outside of North America. And with that, I'll ask our operator to open the call for questions.

[Operator Instructions] Your first question comes from the line of Ryan Zimmerman with BTIG.

So, let's start with the guidance, if we could. I appreciate your comments, Shelley, on guidance. But if we could talk a little bit about kind of the subcomponents or the underlying assumptions on guidance, particularly as it relates to productivity, you expect LDDs to grow, but maybe you could elaborate a little bit further on kind of how you're thinking about productivity of LALs per LDD going forward given the dynamics you laid out?

Yes. Thank you very much, Ryan. I think the biggest driver, obviously, other than Q1 performance to our guidance is the fact that the typical significant increase that we see in March in terms of number of LAL procedures since we've been commercial did not happen, and it was relatively flat to January and February. So I think our guidance really reflects the change in the number of LALs we expect to sell and offset in part by strong LDDs that we expect to be higher than 2024. In terms of the number of LALs per LDD, we certainly model that those increase over the year. And typically, what you see is kind of sequential growth up in Q2, down in Q3, up in Q4. I'm a little reluctant to say that the typical seasonality will be in place this year until we get through the second quarter and just see what the economic impacts are to the economy and how customers are selling to their clients and what we hear back from our ophthalmic customers about the response of patients to a premium IOL procedure versus sticking with a monofocal.

But Shelley, just to be clear, I mean, the math would suggest declines on productivity through the year. And I just want to be clear, is that your assumption given the increase in LDDs?

I think that other than absent perhaps the fourth quarter, that's going to be true on a much small -- larger LDD base relative to the number of LALs, but I'm not exactly predicting that. I think second quarter is probably the biggest risk quarter until we understand what is happening with the economy and how it's affecting our customers and whether, in fact, that's prolonged.

Okay. And then the second question is just -- and this is arguably an impossible question, but I'm going to ask it anyway, Ron, which is, as you think about the components of what led to the miss, you kind of broke down some of it, meaning there was a weakened premium IOL market. There was new product launches. You also alluded to just broader macroeconomic dynamics. And in the press release, I think some of your customers are newer and maybe taking longer to ramp. And so I don't know if you can parse this out, Ron, but there's a lot of things kind of thrown in there. And I don't -- if you can prioritize kind of where you think the biggest drivers are in terms of the impact, what's transient, what's not transient or maybe out of your control, such as the macroeconomic conditions, I think that would be helpful for everyone to understand.

Yes. I would say that as you described, there's been a confluence of factors that happened in Q1, particularly in the latter part of Q1. And I think that all of them are transitory to some extent. Those product launches are something that are planned years in advance. It's unusual to have 2, let alone 3 sequential launches in a relatively short space. And while we're not directly affected by those, they do cause a distraction in the marketplace as doctors are incentivized to trial new lenses. I think the obvious thing that changed in Q1 was the macro environment. And it's a -- that's a more complicated question. I certainly am hopeful that those -- that, that will also improve. But as we've seen from the events even from yesterday, there's going to be some additional changes.

Your next question comes from the line of Young Li with Jefferies.

The first one, I'm wondering regarding utilization by cohort. When we do some checks, obviously, some surgeons can do a lot more than average. I wanted to get a better understanding if you look at the cohorts from earlier years, '21, '22, how does their utilization rate compare versus the average? Where do you see sort of like a natural ceiling or pain point before some of the practice management things you're going to put into place can help them further become more efficient?

Thank you for the question, Young. We have always spoken about the fact that the cohorts of installed LDDs in '21 and prior '22 and '23 have been relatively the same and they kind of move in concert. And we saw that again in the first quarter. So where the number of LALs per LDD went down, it went down in all cohorts, and they're very tight in their distribution. And that continued to be true. Also as we look across our territories in the U.S., the change and the effect in March were consistent throughout the U.S. The '24 class cohort of LDDs installed, it's probably only relevant to look at those installed in the first and second quarter. And what we did see is that they're not growing quite as quickly as the '23 class did during comparable quarters, particularly in the first quarter. So it doesn't have an outsized or even a major effect on the number of LALs per LDD because our installed base is so large. It is something that is a pain point, although small in terms of the total number, but we would like to see them be more confident, particularly in this economic environment.

Okay. Got it. Very helpful. I guess the follow-up is regarding driving innovation and product enhancements. now that we have a better understanding about where Alcon's program is at, Bausch + Lomb also has announced a program, but they also had to deal with the recall. It seems like at least on the competitive front, there's a little bit more visibility. Can you maybe talk a little bit more about the product pipeline or new lenses coming out and what we should expect on that front?

Yes. Thanks for the question, Young. We would agree with you, and I think we've been pretty consistent that we don't see anything on the horizon that is directly competitive to the LAL. And we also believe that continued innovation has been an important driver for growing adoption over the past 5 years that we've been commercial. These have primarily been incremental enhancements that really allow us to get that next group of doctors and patients to adopt the technology. Examples of that have been ActiveShield LAL+. In the fall, we introduced low diopter LALs, which are now beginning to be used in the field. And soon, we're going to be launching our first foray into the correction of higher order aberrations, and I mentioned that on our last earnings call. So I would expect continued such product enhancements to be steadily introduced. And this enables our customers to leverage not only their investment in the capital equipment, but also the investment in their time and that of their employees, learning the clinical skills associated with our technology. And then they can then apply that to more and more of their patient population.

Your next question comes from the line of Robbie Marcus with JPMorgan.

I wanted to try and take Ryan's question in a different way. Shelley or Ron, you raised guidance in the second quarter of '24. And then you were in line on third quarter and you were in line on fourth quarter. And it's the 2 first in-line quarters you had. I believe since being public and really not I would imagine how you thought the second half of the year would turn out. And if you look at Street models, it was on better LDD placements and missed both quarters LAL utilization. So from our point of view, we started seeing LAL utilization slowdown in the back half of the year. Then when you provided guidance for 2025, you actually guided a pretty good amount above the Street. So clearly, you were seeing something that we weren't. And even just as late as last week, competitor Alcon had an Analyst Day, and they didn't bring up any of the same market concerns that you had. So I guess the question is really now with a lot of hindsight, did this start much earlier than you've acknowledged? And is it really a market trend, even though we're not necessarily hearing all of those market trends called out by your peers, and we've all known and been publishing on those competitive launches for months now? Or is it just a utilization issue specifically to LALs? And how do you discern between the 2?

Maybe I'll start, Robbie. So I think the -- while our LAL procedural growth didn't meet some of the expectations that were out there, the LALs per LDD metric continued to be high through the year. And given our growth in installed base, that drove continued growth overall. And so I think that, that -- and we, in fact, if you look at the overall market and take out LAL growth, the overall market has -- was not growing and was negative. And that was commented at the time, as I recall. The -- and that probably was -- because of our growth was probably led us to underappreciate the softening in the market as well as the impact of these competitive trialing incentives that others had also mentioned. So I think that led to a perhaps underestimate of those impacts and again, laid a foundation, which when coupled with very significant disruption in consumer sentiment led to the effects in Q1.

Yes. And to address your comment more specifically about the third and fourth quarters, you are correct. We beat and raised in the first half, both in the first quarter and the second quarter and raised guidance both times and then, of course, over exceeded in the second quarter. We raised guidance for the second half and we met that increased guidance and -- but we did not exceed it in the second half. And so I do think that Q3 definitely was affected by more vacations as we discussed. Q4, I think that it was strong, but certainly not as strong as the Street expected. It was consistent with our raised guidance, but we weren't able to rise above that. And as Ron said, I think that we were less aware of market dynamics and the rest of the market was shrinking. And certainly, we recall our competitors talking about that as well, but it was really masked by our own performance. And so I think as we went through the second half, we didn't recognize the overall market dynamics and the shrinkage in the second half. And as you know, since 2022 or so, the market has remained roughly at 18% to 19% of total IOL procedures, and that really was because of us. So I think that we looked into 2024 with -- 2025 with the same confidence that we had in 2024 up until the point that March LALs did not increase substantially as they typically do in that first quarter period.

Maybe a follow-up. Shelley, you -- you raised -- you lowered the guide on sales ballpark $30-ish million for 2025 and OpEx about $10 million. There's still a big -- let's just say, at current rates, there's really no crossover into free cash flow generation, at least not for a very long time, assuming trends change or hold. How are you thinking about time lines on cash flow breakeven, your cash needs and any possibility for a need for a raise?

Okay. Yes. Thank you very much. And I think that, that's an astute point you brought up. We're bringing down kind of in the middle of the range, guidance by $23 million and OpEx down by $10 million. So in our previous guidance, we were putting more money down to the bottom line each and every quarter, except for first quarter typically, which is a heavier cash use quarter due to payment of prior year bonuses. But in this guidance, we are assuming that we need to put relative to our revenue, more resources into sales and marketing in particular, I think we need to be -- we're very active with our customers, which we have about 200 people that are customer-facing. We'll continue to add to those as we add customers. And so I'm not expecting that we're dropping that gross margin increase to the bottom line in the OpEx guide as well. However, as you know, we have more than adequate cash to get to cash flow breakeven and profitability, but it does impact the timing of when we may meet cash flow breakeven as well as GAAP breakeven because, of course, we'll continue to have investments in inventory and accounts receivable as we grow. And that is deliberate on our part in terms of guidance. We want to make sure that during this period of time, we don't under-resource and we continue to stay close to our customers. Would you add anything to that, Ron?

No.

Your next question comes from the line of Steve Lichtman with Oppenheimer.

Just a follow up on that last point in terms of where the spend is going to be focused. During the prepared remarks, Ron, you also highlighted strongly supporting acceleration of new customer business models. Can you sort of -- can you double-click on that a little bit, talk about what your efforts are going to be there? Because I guess to the extent you can further streamline those efforts that could have an impact on the end customer price and therefore, potentially offset some of the macro headwinds. So maybe you could talk a little bit more about what you're doing -- what you're going to be doing specifically on those centralized business models.

Yes. Again, these are third-party innovators who are seeing the opportunity with the LAL technology to make it potentially more approachable for some ophthalmic practices in -- across the country. And that's been going on actually for a number of years. And we've seen several individually successful efforts in this. Our role in that is similarly supportive to what we do with our traditional practices, providing both marketing and training and clinical support not only to the stand-alone light treatment center, but also to the individual doctors who make use of that and providing them with both the clinical and marketing materials and education that helps them offer the LAL to more of their patients. So I think that it will be an expansion of those activities, very similar, but directed in a slightly different way than what we have traditionally done.

Okay. Got it. Just wondering on the recent recall announcement from one of your competitors, how are you thinking about that in terms of potential upside to your revised guidance? Or are you not factoring that in at this point? How are you thinking -- I know it's fresh, but how are you thinking about that?

Yes, I would agree with you, Steve, that there's no way for us to know what the duration of that would be. I think it's largely not going to be as impactful on us as it would be for some of the other competitors. But certainly, anything that gives us an opportunity to let surgeons and patients see the benefits of the LAL approach to high-quality customized vision, that's an opportunity that we're going to take.

Got it. Just quickly, obviously, not the focus of this call, but you did mention the CE Mark. I assume no revenues built in for this year at this point, but which countries are you going to be focusing on as you sort of build toward that for, I guess, in 2026?

So as we've talked about in the past, in Europe, we'll focus on the major economies in Europe that already have strong premium IOL markets, similar to the approach that we've taken in Asia. And so those are going to be the major markets that everyone is familiar with. And while we don't see significant revenue in 2025, we will start to grow our presence there. It takes time. And in Europe, it takes some things -- sometimes new product introductions take a little bit more time. So we certainly don't want to -- we're not going to be going slow.

Next question comes from the line of David Saxon with Needham & Company.

So I wanted to maybe first ask on LDD. So on the market, if the premium IOL market volumes are softer, are you assuming in guidance that, that translates into softer LDD demand or longer sales cycles? Or kind of how does that market view inform how you think about LDD placements and kind of customers or prospective customers' appetite for the capital purchase?

Yes. Thank you. That's a good question. We did again say that we would expect more LDD sales in 2025 than we had in 2024. But the overall guidance does assume in our internal numbers that, that number is a bit lower. And that would certainly be consistent with our guidance. As Ron had said earlier, practices still are struggling with profitability because of Medicare cuts, other reimbursements across other product lines. And as far as we know, premium IOLs are the only product where they can bill Medicare for the minor amount that they provide as well as a direct cost to the consumer. It's a profitable procedure for them. And during these periods of time, LASIK drops precipitously. That just goes with the economy because that certainly can be put off and it's a younger population. The population of roughly 65-plus year olds, of course, remain a bit more isolated. But certainly, turmoil and particularly in their assets such as stocks can result in some delay or different choices temporarily. We do think that this is temporary, though.

Okay. Great. And then, Shelley, you mentioned profitability, and obviously, that's a focus for docs and practices. So I guess, how are you thinking about pricing at this point? You've held pricing on the LAL side at least. So does this change how you think about pricing? And then in the -- I forget if it was in the script or to a question, but you talked about how the 2024 class utilization was slower than prior cohorts, at least in the first half of '24. So what does that mean in terms of like the cohorts you've penetrated so far? Have you kind of fully penetrated the higher volume group or segment of ophthalmologists? And now are we kind of in the average to lower volume practices?

Maybe I'll start. So with respect to the last question, I don't think that we've fully penetrated any group. There are a wide variety of practices that have not yet adopted our technology. We have about 1,000 LDDs. There are about 2,000 surgeons. There are 10,000 cataract surgeons out there with at least several to more thousands of offices where cataract surgery is -- cataract surgery patients are seen. So I certainly don't believe that we're anywhere near a saturation point and even by class of surgeon. And then the -- I'm sorry, the second -- the first question was?

Yes. Just around pricing. I mean, LALs are kind of the highest, yes, so how are you thinking about that in terms of like trying to allow doctors to kind of protect some level of profits while the market volumes are kind of weaker.

Yes. So in terms of pricing, the cost of the LAL is a relatively small fraction of the price that doctors charge to their patients. So we believe that the value provided by the technology justifies its cost, which is somewhat higher than the highest level presbyopia-correcting IOLs. We have kept pricing stable since our introduction into the market about 5 years ago. And part of the ways that we've been able to do that is through efficiencies. And we fully manufacture all the components of the technology in the U.S. specifically here in California. And so we're not going to be significantly impacted by tariffs. And I think that we'll try to maintain a good relationship between the value and the price that we charge to our customers.

Your last question comes from the line of Danielle Antalffy with UBS.

My question is really just pretty straightforward, I think. I mean, I guess I am just a little concerned about whether -- or what gives you confidence that this hasn't been the last few years, you guys just got the low-hanging fruit here, and you've now sort of penetrated what you are going to penetrate of the premium market. So I appreciate all the commentary on the economy, macroeconomic environment affecting the premium market. But more if we're just looking at LAL penetration within the premium market. Ron, maybe you can talk about what gives you confidence that that's not what's happening here.

Well, I would say 2 things give me confidence. One is just my interactions with doctors and practices throughout the country. And the vast number of practices that not only haven't adopted our technology, but don't know too much about our technology. It's very clear that we're still at a relatively early phase of the market penetration for this technology. And I would just point out that it would be a really amazing coincidence if we peaked out in the adoption curve exactly when there has been a confluence of macroeconomic and market trends over a short period of time. I just don't believe in those kinds of coincidences. So I'm confident that these are going to -- that these things will pass and that we'll continue to penetrate the market, which is the largest opportunity in -- certainly in anterior segment ophthalmology.

There are no further questions at this time. I would now like to turn the call back over to Ron Kurtz, CEO, for closing remarks. Please go ahead.

Thank you, operator, and thank you all again for your interest in RxSight. We look forward to seeing some of you later this month in Los Angeles at the meeting of the American Society for Cataract and Refractive Surgery as well as providing further updates at our regularly scheduled first quarter 2025 conference call in early May. Goodbye.