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spk16: by welcome to the RXSITE First Quarter 2024 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 this session you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question please press star 1-1 again. Please be advised through today's conference is being recorded. I would now like to hand the conference over to your speaker today, Oliver Morozovic, VPM's Investor Relations. Please go ahead.
spk20: Thank you, operator. Presenting today are RXSITE President and Chief Executive Officer Dr. Ron Kurtz and Chief Financial Officer Shelley Toonan. Earlier today RXSITE released financial results for the three months ended March 31, 2024. 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, May 6, 2024 and will include forelooking 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 today 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 play undue reliance of forelooking statements and we disclaim any obligation to update or revise these forelooking statements. We will also discuss certain non-GAAP financial measures, disclosures regarding non-GAAP financial measures including reconciliations with the most comparable GAAP measures can be found in the press release. Please note that this conference will be available for audio replay on our investor website. With that I will turn the call over to our President and Chief Executive Officer
spk02: Dr. Ron Kurtz. Ron? Good afternoon and thank you for joining us. In a moment Shelley will review our first quarter financial results and provide an update to our 2024 guidance which we believe once again demonstrates the sustained clinical and commercial performance of our light adjustable lens technology. After Shelley's financial review I will return with some updates from the recent American Society of Cataract and Refractive Surgery meeting which included the full launch of LAL Plus, the newest member of our light adjustable lens platform. Please take it away Shelley.
spk19: Thank you Ron and good afternoon everyone. RX-8 generated first quarter 2024 revenue of $29.5 million, up 69% compared to the $17.5 million in the year ago quarter and up 3% compared to $28.6 million in the fourth quarter of 2023. During the quarter we sold 20,218 LALs and generated $19.9 million in revenue up 92% and 12% compared to the first and fourth quarters of 2023 respectively. In Q1 of this year LAL revenue represented 67% of total revenue and increased from 59% and 62% in the first and fourth quarters of 2023 respectively. During the first quarter of 2024 we sold 66 LDDs up 18% to 56 units in the year ago period. As expected capital equipment sales reflected the typical first quarter seasonality, therefore on a sequential basis our LDD units sold for the quarter were down 14% compared to the 77 units in the fourth quarter of 2023. During the quarter LDD sales generated revenue $8.7 million, up 35% and down 13% versus the first and fourth quarters of 2023 respectively. As of March 31, 2024 our install base stood at 732 units, up 61% and 10% versus the first and fourth quarters of 2023 respectively. Gross margin in the first quarter of 2024 was 70% compared to 59% and 62% in the first and fourth quarters of 2023 respectively. The increase primarily reflects the shift in product mix with the higher margin LAL revenue advancing to 67% of revenue. Lower cost to manufacture both LAL and LDD also contributed to the gross margin expansion in the quarter. SG&A expenses in the first quarter of 2024 were $23.3 million, representing an increase of $7 million or 44% versus $16.3 million in the year ago quarter. This year over year change was primarily due to an increase in personnel costs, higher stock-based compensation expense, and additional marketing study spending. On a sequential basis, SG&A expenses increased 10% due primarily to higher number of personnel and phase four commercial study costs. During the first quarter of this year R&D expenses rose 11% to $8 million compared to $7.2 million in the first quarter of 2023. This year over year change primarily reflects an increase in salaries and stock-based compensation compared to the fourth quarter of 2023. R&D expenses in the first quarter rose by 9%, primarily driven by a one-time change in allocation of certain R&D related costs. We reported a gap net loss in the first quarter of 2020. This compared to a gap net loss of $9.1 million or a loss of 25 cents per basic and diluted shares using weighted average shares outstanding of 36.8 million shares. This compares to a gap net loss of $13.2 million or 42 cents per share on a basic and diluted basis in the first quarter of 2020. Note also that stock-based compensation in the first quarter of 2024 was $4.7 million resulting in a non-gap loss of $4.4 million or a loss of 12 cents per basic and diluted shares. Please refer to the unaudited non-gap reconciliation and disclosure included in today's press release for more comparative information. We ended the first quarter of 2024 with cash, cash equivalents in short-term investments of $125.4 million compared to $127.2 million on December 31, 2023. Cash used in the quarter for operations was offset by 8 million of net cash received from stock option exercise. While we always have some cash generated from stock option exercises, more stock options were exercised than normal given the longer than usual open window and increased stock price. Approximately 16% of the stock option shares were exercised related to 10b51 transactions. We are pleased to announce that in April of this year we entered into a new lease and amended two existing leases at our campus in Aliso v. California to extend the rental terms and options to ensure continued long-term access to our facilities, acquire additional square footage to expand manufacturing, and align the lease end dates for each of our four facilities. Moving on to our 2024 outlook. We are increasing our 2024 revenue, growth margin, and operating expense guidance as follows. Revenue of $132 million to $137 million, up from previous guidance of $128 million to $135 million, implying -over-year growth of 48% to $137 million, and assuming continued sequential quarterly growth with normal seasonality in the third quarter due to summer vacations by both patients and doctors. Growth margin of 68% to 70% up from our previous guidance of 65% to 67%. The new guidance is primarily driven by slightly higher than expected launch revenue contributions from the LAL and continued cost reductions to reduce both our LAL and LDD, along with continued pricing discipline for our LDD. Growth margin is likely to vary modestly during the year depending on the mix between LAL and LDD revenue in any one quarter. Operating expenses of $126 to $130 million, up from our previous guidance of $125 to $128 million, and representing an implied increase of 21% to 25% over 2023. Our spending is focused on continuing efforts to leverage our commercial momentum, grow our educational efforts, develop our pipeline, and expand internationally as regulatory approvals are obtained. Note that the operating expense estimate includes non-cash stock-based compensation expenses between $22 and $25 million. With that, I'll turn the call back to Ron.
spk02: Thank you, Shelley. RxStripe's strong first quarter performance was followed by continued keen interest in our light adjustable lens technology at the recent annual meeting of the American Society of Cataract and Repractive Surgery, the second largest U.S. ophthalmic conference with over 5,000 attendees. The LAL was prominently featured in over 20 formal session presentations, and its use in various clinical settings was a common topic in discussion forums. In one of these presentations, Dr. Hunter Newsom reported on data collected from approximately 1,000 bilaterally implanted LAL subjects at nearly 100 practices. Approximately 90% of LAL patients attained binocular uncorrected vision of 2020 or better, while over 90% were able to read J2 or 5-point font with both eyes. Dr. Newsom also discussed the newest member of the RxI platform, the LAL+, presenting initial clinical data from 10 practices that compared monocular distance corrected vision in over 200 LAL+, and 100 LAL eyes. While both groups attained excellent distance vision, LAL+, eyes exhibited more than a line improvement at near. Both groups demonstrated excellent binocular vision with comparatively high rates of patients achieving 2020 or better. Doctors now have two LALs to choose from to achieve the most customized visual outcomes possible after cataract surgery. With the growing number of doctors and practices offering the LAL and LAL+, as well as increasing uptake by patients, we believe we are establishing a new standard for premium IOL offerings in the U.S. Based on this momentum, we are even more committed to reaching the full potential of RxSight's unique adjustable technology and premium market opportunity. This includes expanding programs that enhance the clinical knowledge base of ophthalmologists, optometrists, and other eye care professionals, thereby leading to a better informed and served public. We believe that when patients understand the full benefits of adjustability, they are more likely to choose an LAL over a fixed lens alternative and thereby optimize their vision in ways that are meaningful to them. Reaching our full potential also includes maintaining our commitment to rapid innovation, exemplified not only by the recently commercialized LAL+, but also by ongoing advancements to the LDD and LAL insertion technology. In addition, we continue to believe that the success of the LAL in both the U.S. and Canada can be replicated in most major markets and look forward to building successful international programs, particularly in Asia and Europe following regulatory approvals. Overall, we feel our strong first quarter results, along with a very positive reception at this year's ASCRS, further support our vision to make adjustability the standard for premium cataract and lens replacement surgery. With that, I'll ask the operator to open the call for questions.
spk16: Thank you. As a reminder, to ask a question at this time, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment while we compile our Q&A roster. Our first question is going to come from the line of Robbie Marcus with JPMorgan. Your line is open. Please go ahead.
spk07: Oh, great. Thanks for taking the question. Congrats on a very nice quarter. Two from me, maybe first to start. Volumes both in LAL and LVD were really strong in the quarter, but also so was pricing, if I do my math correct here. Maybe speak to what you're seeing in the field in terms of both adoption trends as you continue to place more than expected LVDs and good utilization, but also on the pricing side because it continues to be robust for both of them. Thanks.
spk19: Okay, why don't we start with Ron on the adoption trends and I'll follow up on the ASPs.
spk02: Yeah, I think that, you know, as you noted, Robbie, the adoption trends continue to be very positive. You know, we think that's a combination of the clinical outcomes with the now the LAL Plus, as well as the continued focus of our customer base on the premium IOL market and the potential to offset, you know, the revenue losses that they're seeing in their reimbursed areas. So overall, you know, we anticipate continued strong adoption, and with that, we've been able to maintain good pricing discipline.
spk19: Thank you, Ron. And as you were calling, you know, Robbie, in the third quarter when we introduced the newer LVD, we increased our price by about 10%. And at that time and again at year end, we felt like the ASP would continue to hold through going into 2024. We certainly saw that in the first quarter. The ASP was up about $3,000 as compared to the fourth quarter. I don't think it's any particular, you know, item that increased that as much as mix of customers, how large they are, whether it was second or third LVD. And, you know, again, I think really good pricing discipline from our sales force bolstered by the fact that the results are excellent clinically, and that we have more and more references for
spk18: new doctors to go to.
spk07: And great, maybe as a follow up, I wanted to talk on competitive environment. By my math, they're closing in on 10% or so of the premium IOL market. You know, I imagine that's a pretty disruptive mark as you look at your competitors. You're starting to take larger shares and, you know, not just some early adopters, but hitting more of the mass market appeal. What, if anything, are you seeing in terms of a response from your competitors? And how do you feel about your ability to continue to grow and take share as you're moving up the adoption curve? Thanks a lot.
spk02: Well, you know, I would say that, as we've noted before, a significant percentage of LAL cases, you know, are coming from patients who otherwise would not have selected a premium IOL. And because of that, you know, while some of our numbers are coming from other competitors in the premium space, a very large percentage are coming from either standard monofocal IOLs or toric IOLs, which tends to have less focus than the presbyopia correcting IOLs. So, you know, I think that, you know, that may not generate as much interest as, you know, as the 10 percent number that you quoted might otherwise. Shelly, do you have anything you want to add?
spk19: No, I don't think so. I think that people are taking notice of us. Certainly at ASCRS, we had, you know, you should talk about just kind of the booth traffic we had, as well as the number of presentations we had in the booth and number of papers presented at ASCRS. I think that certainly, you know, has led to higher visibility for
spk02: us. Absolutely. You know, I think that we're, you know, there are more and more practices that are using the technology and getting excellent results, and that word travels. But in terms of, you know, competitors, you know, I think that they've been aware of our excite for some time and will continue to follow it.
spk14: Thanks a lot.
spk16: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Ryan Zimmerman with BTIG. Your line is open. Please go ahead.
spk05: Good morning and or afternoon, excuse me, too many earnings calls. I just want to ask about a couple things. So, you know, the install base now is past 700. You've had a number of units in the field now for numerous years. As that install base grows, I'm just wondering if there's any service revenue considerations we should be thinking about. I would imagine that can start to grow and maybe, you know, step up a little bit over course this year and into 2025.
spk19: Yeah, I think that's a good question, Ryan. We do have a line on our P&L for service and accessories, and it's exactly what you talk about, primarily service revenue. When we sell the LDD in accordance with GAP, we call about about $7,000 out of the LDD revenue and ASP. And that is amortized over a year period into the service line. And in addition, we find about 80% of our customers when their one-year warranty expires take a service contract with us, and the other 20% tend to use time and material. And so we should continue to see that line grow as our install base grows.
spk05: Okay. And then, you know, Shelley, margins were fantastic this quarter. Probably the, you know, most, I think, encouraging thing, you know, for long-term investors. You're guiding a little below 70%. You did over 70% this quarter, just a hair. You know, why does that regress in the rest of the year below 70%? Because, I mean, you're just on this fantastic trajectory with more LAL sold to drive margins higher.
spk19: Yeah, I think that the primary driver for margin in any given quarter is the percent of LAL as a percent of revenue. In the first quarter, it was quite high because typically you see lower LDD sales, you know, capital sales, which we did. So I think that as you go through the next three quarters, we can see some different mix shifts as well. And of course, the LDD has a much lower gross margin than the LAL. And of course, as I mentioned, you know, we did have a nice ASP bump in the first quarter as well. That might be usual or unusual as well. And, you know, we've been able to roll in a lower material cost components more quickly than we had planned. But I think really the difference in any given quarter is going to be percent of LAL and percent of LDD.
spk06: Thanks,
spk16: Michelle. Thank you. And one moment as we move on to our next question. Our next question is going to come from the line of Patrick Wood with Morgan Stanley. Your line is open. Please go ahead.
spk13: Fantastic. Thank you for taking the questions. I guess the first one, I know you guys don't split the guy down, but just qualitatively for LDD placements, would you expect that kind of similar growth that we saw year on year in LDD placements in Q1? Would you expect that to be a similar kind of growth trajectory through the year or a bit of an uptick in that and a drop in the LALs? I'm just trying to work out roughly the passing of those two things out, even just qualitatively.
spk19: Yeah, qualitatively, of course, you know, the LAL grows much faster than the LDD, and that's to be expected because our primary focus is not only just getting new customers, but getting new customers up faster as well as continuing to penetrate in our existing customers and get them to continue to grow. So we have seen this shift between the LAL and LDD. The more install base you get, you continue to get that. But in terms of breaking it out, I think kind of the general trends that we've been in for the last three or four years with LALs increasing much faster than LDD is indicative of what we want to do.
spk13: That makes sense. Thank you. And then again, qualitatively, of the LDD placements that you've seen in the last three, four, five months outside of things, can you give us some sort of flavor how much of that is new accounts, existing accounts, buying a second system, just how that's trended over time very recently would be helpful?
spk19: Yeah, it's predominantly new accounts. And what you see now a little bit is I wouldn't call them repeat accounts in the following sense, because each sale is to an individual office, although the doctor or the underlying owners may be the same, right? Because you're still selling to the primary doctors in the practice that want to pick up the LAL. Some doctors have two or three separate offices. They start in one, but then they might have different partners in their second and third offices. You see other people that are part of a larger network or a buying group, and each of those are individual sales. But I would say the vast majority are brand new customers to us that we haven't had in our install base. There always are some that buy that we know, and they're really just expanding their footprint in their practices or in their network.
spk12: Brilliant. Thank you so much.
spk17: Thank you. And one moment as we move on to our
spk16: next question. And our next question is going to come from the line of David Sexton with Needham and Company. Your line is open. Please go ahead.
spk11: Hi, this is Joseph on for David. Just wanting to know how you guys are thinking about the landscape with Odyssey and early launch and Optics Pro coming in the future.
spk02: Well, thank you. I would categorize those competitive offerings as being part of the fixed lenses that are very similar to other fixed lenses in the marketplace. And so, you know, while they may gain some attention at the end of the day, they're going to be compared against those more similar products than, say, the light adjustable lens. So, you know, we expect that the market will continue to see new offerings, but that the LAO will continue to have a unique set of benefits for patients.
spk11: Okay, gotcha. And then maybe just a quick one to give some color around, you know, balance sheet and how you guys are thinking about runway to pre-cash for profitability.
spk19: Yeah, I think that what you have seen is reduced cash use in each quarter as we've increased both revenue and gross margin. What you did see in this guidance is that we, you know, had a pretty big increase in our guidance for gross margin, but we also did increase OPEX a bit. And I think the increase in gross margin gives us an opportunity. We let most of those dollars fall to the bottom line, but we will continue to continue this balance between growth and gross margin and percent and absolute dollars with continued investment in OPEX. But I think we've been very careful in this guidance balance though.
spk11: Okay, sure. Thank you very much for taking our questions.
spk16: Thank you. Thank you. And one moment for our next question. And our next question is going to come from the line of Tom Steffen with Stiefel. Your line is open. Please go ahead.
spk04: Great. Hi, everyone. Thanks for taking the questions. Maybe I'll start with LAL Plus. Could you maybe, I guess, qualitatively explain a bit how LAL Plus was contemplated in 2024 guidance, maybe in terms of the cadence of the rollout? I guess, in other words, does guidance assume kind of a methodical ramp of LAL Plus? Is it a fast ramp up, maybe somewhere in between? Any color there would be helpful.
spk19: Okay. You know, in terms of mix between LAL and LAL Plus, they're priced at the same amount at $1,000 per unit, right? And I think that for us, and Ron can comment on this a little bit more, part of the pricing strategy, of course, is that we want the doctor and patient to pick the ideal lens for them, knowing that both are adjustable. And we think that, you know, the results that we had in the first quarter are part of just our original guidance or strategy for the year with this concept of having two LALs in our product family overall. I don't know if you would comment on anything additional on that, Ron.
spk02: No, I mean, recall that the LAL Plus was approved in 2023, and it was, you know, we had some initiated some initial phase four clinical studies in the fall. So, you know, we certainly had that in our minds developing 2024 guidance.
spk04: Got it. That's helpful. And then just my follow-up, I guess on gross margin, Shelley, can you maybe level set us on where gross margins stand between your different products? Because when I run a low 30% gross margin on the LDD sales, I'm arriving at maybe 85% plus gross margin on the rest of the business. Are those fair places to be on both sides? And I guess I'm mainly curious about, you know, where LAL gross margin is tracking toward. Thanks.
spk19: Yeah, well, we don't break out both of them. Certainly we've provided some, you know, information overall. As I've always stated, you know, our gross margin on the LDD, these people have equipment we try and get between 20 and 30%. As you go back into early 23, we were below the 20% or right at. Today, we are above the 30%, and what I would call well above. Overall, and, you know, just this, you know, little $3,000 higher ASP in the first quarter, you know, contributed to about a 2% point increase in gross margin for the LDD. So we're trending a bit higher than we would otherwise. And I contribute that to one good pricing ASP discipline with our sales force, the value of the product, as well as the fact that we were able to roll in some lower material costs a little bit earlier. On the LAL side, we don't, you know, comment, but we believe that that product is, you know, in this kind of range, in the 80% something range, and probably likely over a very long time to become a 90% product. But that's a, you know, kind of way out there. You've got to get your volumes up for that to happen.
spk03: That's great. Thanks, Shelley. Thanks, Ron.
spk16: Thank you. Thank you. And one moment for our next question. And our next question is going to come from the line of Larry Beegelson with Wells Fargo. Your line is open. Please go ahead.
spk08: Good afternoon. Thanks for taking the question. So on the Q4 call, you said you'd be talking more about international markets later this year. And today I heard spending is going towards OUS clearances. And Ron, you spoke more about Europe and Asia in your prepared remarks today that I heard on the Q4 call. So my question is, does this imply you're closer to other major market launches? And what are you including in the guidance for OUS markets in 2024? And I had one follow up.
spk02: Yeah, you know, I don't think anything's changed, Larry. We continue to focus, you know, primarily on the U.S. market. But we pursue our regulatory filings outside the U.S. in attractive markets. And we certainly will be updating as we make progress in those.
spk19: And I think as far as revenue goes in 2024, obviously we're in Canada. That has grown nicely for us and been a good market for us. I think in terms of the other markets, you know, these regulatory cycles are getting pretty long. For instance, in Europe, we've seen it longer than we originally anticipated and continues to get pushed out. And if we have anything, you know, outside of Canada internationally, I would expect in 2024 it would be pretty minor.
spk08: Got it. And, you know, one follow up question for me, utilization, it looks like it was about 9.2 LALs per LDD per month in the first quarter and it grew about 5% a year. It looks like it's a little slower than what we've seen in the last few quarters. You know, why is that and how are you guys thinking about utilization for the rest of this year? Thank you.
spk19: So I think the difference between my numbers and your numbers is that we calculate the number of LALs per LDD by taking as the number of LALs over the number of LDDs installed at the beginning of the quarter, right? So you don't get a lot of normal LAL revenue out of new installs. But in fact, kind of if I look back, we were at 10.2 in the fourth quarter and we were at 10.1 in the first quarter, which I think is terrific overall. And kind of if you go back to, let's say, in Q4 of 2022, we were about 8.9. So I think that gotten good sequential growth, although a little dip in the third quarter of 2023 for Steve and
spk01: Al. All right. Thanks, Shelly.
spk16: Thank you. And one moment for our next question. Our next question comes from the line of Steve Lichtman with Oppenheimer & Co. Your line is open. Please go ahead.
spk10: Thank you. Hi, Ron and Shelly. And congratulations. I wanted to ask, Ron, I think you mentioned targeting optometrists in terms of driving awareness. I think you talked to that at ASCRS as well. Can you talk a little bit about what that looks like in the field in terms of how you approach that and some of the potential benefits in terms of referrals and things like that from targeting that group? Thanks.
spk02: Yeah. So optometry is obviously a very significant part of eye care, particularly in the US, and are integrally involved with cataract surgery, both in terms of counseling of patients preoperatively as well as helping to manage patients through the course of their post-op periods. And that can be either independent or separate optometric practices that work in conjunction with ophthalmic offices, or it can be optometrists within ophthalmic practices. And we obviously, for those practices that have our technology, many of them have optometrists and we work very closely with them. Many of them have become very experienced and knowledgeable about our technology. They are just as academically minded as the ophthalmologists and like to present at their respective meetings. And we see more of that. We certainly want to support that. And then through our ophthalmic practices, we certainly want to support their educational events with optometrists in their community as well. And that's something that's important in driving awareness of the technology, which is very attractive just fundamentally to optometrists generally because it fits with their overall ethos of quality of vision.
spk10: Great. And then just as a quick follow-up, are you adding to the sales force on the LDD side this year? And if so, how much are you increasing that?
spk19: Yeah, I think that if we look at our hand headcount ads, they're primarily in our clinical applications and LAL folks who work closely with the LDD. We may add a few on LDD, but certainly not at the rate that we add to those two other groups.
spk09: Great. Thank you. Thank you, Steve.
spk16: Thank you, Steve. Thank you. And I would now like to hand the conference back to CEO Ron Kurtzwisk for closing remarks.
spk02: Well, thank you all for your time and attention today. We appreciate your interest in our excite and look forward to updating you on our progress in future quarters. Goodbye.
spk16: This concludes today's conference call. Thank you for participating. You may now disconnect. Good day and thank you for standing by. Welcome to the RX site, first quarter, 2024 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'll need to press star one one on your telephone. You will then hear an automated message advising you. Your hand is raised to a draw. Your question, please press star one one again. Please be advised through today's conferences being recorded. I would now like to hand the conference over to your speaker today. Oliver more archivist VPN investor relations. Please go ahead.
spk20: Thank you, operator. Presenting today are our excite president and chief executive officer, Dr. Ron Kurtz and chief financial officer, Shelley Tune in. Earlier today, our excite released financial results for the three months ended March 31st, 2024. 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, May 6, 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 today 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 play undue reliance with forward-looking statements, and we disclaim any obligation to update or revise these forward-looking statements. We will also discuss certain non-GAAP financial measures. Disclosures regarding non-GAAP financial measures, including reconciliations with the most comparable GAAP measures, can be found in the press release. Please note that this conference will be available for audio replay on our investor website. With that, I will turn the call over to our President and Chief Executive Officer, Dr. Ron Kurtz.
spk02: Ron? Good afternoon, and thank you for joining us. In a moment, Shelley will review our first quarter financial results and provide an update to our 2024 guidance, which we believe once again demonstrates the sustained clinical and commercial performance of our light adjustable lens technology. After Shelley's financial review, I will return with some updates from the recent American Society of Cataract and Refractive Surgery meeting, which included the full launch of LAL+, the newest member of our light adjustable lens platform. Please take it away, Shelley.
spk19: Thank you, Ron, and good afternoon, everyone. R-Excite generated first quarter of 2024 revenue of $29.5 million, up 69% compared to the $17.5 million in the year-ago quarter, and up 3% compared to $28.6 million in the fourth quarter of 2023. During the quarter, we sold 20,218 LALs and generated $19.9 million in revenue, up 92% and 12% compared to the first and fourth quarters of 2023, respectively. In Q1 of this year, LAL revenue represented 67% of total revenue, an increase from 59% and 62% in the first and fourth quarters of 2023, respectively. During the first quarter of 2024, we sold 66 LDDs, up 18% to 56 units in the year-ago period. As expected, capital equipment sales reflected the typical first quarter seasonality. Therefore, on a sequential basis, our LDD units sold for the quarter were down 14% compared to the 77 units in the fourth quarter of 2023. During the quarter, LDD sales generated revenue of $8.7 million, up 35% and down 13% versus the first and fourth quarters of 2023, respectively. As of March 31, 2024, our installed base stood at 732 units, up 61% and 10% versus the first and fourth quarters of 2023, respectively. Gross margin in the first quarter of 2024 was 70% compared to 59% and 62% in the first and fourth quarters of 2023, respectively. The increase primarily reflects the shift in product mix, the higher margin LAL revenue advancing to 67% of revenue. Lower cost to manufacture both our LAL and LDD also contributed to the gross margin expansion in the quarter. SG&A expenses in the first quarter of 2024 were $23.3 million, representing an increase of $7 million or 44% versus $16.3 million in the year-ago quarter. This -over-year change was primarily due to increase in personnel costs, higher stock-based compensation expense, and additional marketing study spending. On a sequential basis, SG&A expenses increased 10%, due primarily to higher number of personnel and phase four commercial study costs. During the first quarter of this year, R&D expenses rose 11% to $8 million, compared to $7.2 million in the first quarter of 2023. This -over-year change primarily reflects an increase in salaries and stock-based compensation compared to the fourth quarter of 2023. R&D expenses in the first quarter rose by 9%, primarily driven by a one-time change in allocation of certain &D-related costs. We reported a gap net loss in the first quarter of $9.1 million for a loss of $0.25 for basic and diluted shares, using weighted average shares outstanding of 36.8 million shares. This compares to a gap net loss of $13.2 million, or $0.42 per share on a basic and diluted basis in the first quarter of 2023. Note also that stock-based compensation in the first quarter of 2024 was $4.7 million, resulting in a non-gap loss of $4.4 million, or a loss of $0.12 per basic and diluted shares. Please refer to the unaudited non-gap reconciliation and disclosure included in today's press release for more comparative information. We ended the first quarter of 2024 with cash equivalents and short-term investments of $125.4 million compared to $127.2 million on December 31, 2023. Cash used in the quarter for operations was offset by $8 million of net cash received from stock option exercise. While we always have some cash generated from stock option exercises, more stock options were exercised than normal, given the longer than usual open window and increased stock price. Approximately 16% of the stock option shares were exercised related to 10b51 transactions. We are pleased to announce that in April of this year, we entered into a new lease and amended two existing leases at our campus in Aliso v. California to extend the rental terms and options to ensure continued long-term access to our facilities, acquire additional square footage to expand manufacturing, and align the lease end dates for each of our four facilities. Moving on to our 2024 outlook, we are increasing our 2024 revenue, growth margin, and operating expense guidance as follows. Revenue of $132 million to $137 million, up from previous guidance of $128 million to $135 million, implying -over-year growth of 48% to 54%, and assuming continuing sequential quarterly growth with normal seasonality in the third quarter due to summer vacations by both patients and doctors. Gross margin of 68% to 70% up from our previous guidance of 65% to 67%. The new guidance is primarily driven by slightly higher than expected launch revenue contributions from the LAL and continued cost reductions to produce both our and LDD, along with continued pricing discipline for our LDD. Gross margin is likely to vary modestly during the year depending on the mix between LAL and LDD revenue in any one quarter. Operating expenses of $126 to $130 million up from our previous guidance of $125 to $128 million, and representing an implied increase of 21 to 25% over 2023. Our spending is focused on continuing efforts to leverage our commercial momentum, grow our educational efforts, develop our pipeline, and expand internationally as regulatory approvals are obtained. Note that the operating expense estimate includes non-cash stock-based compensation between $22 and $25 million. With that, I'll turn the call back to Ron.
spk02: Thank you, Shelley. RxStripe's strong first quarter performance was followed by continued keen interest in our light adjustable lens technology at the recent annual meeting of the American Society of Cataract and Refractive Surgery, the second largest U.S. ophthalmic conference with over 5,000 attendees. The LAL was prominently featured in over 20 formal session presentations, and its use in various clinical settings was a common topic in discussion forums. In one of these presentations, Dr. Hunter Newsom reported on data collected from approximately 1,000 bilaterally implanted LAL subjects at nearly 100 practices. Approximately 90% of LAL patients attained binocular and corrected vision of 2020 or better, while over 90% were able to read J2 or 5-point font with both eyes. Dr. Newsom also discussed the newest member of the RxI platform, the LAL+, presenting initial clinical data from 10 practices that compared monocular distance corrected vision in over 200 LAL+, and 100 LAL eyes. While both groups attained excellent distance vision, LAL+, eyes exhibited more than a line improvement at near. Both groups demonstrated excellent binocular vision with comparatively high rates of patients achieving 2020 or better. Doctors now have two LALs to choose from to achieve the most customized visual outcomes possible after cataract surgery. With the growing number of doctors and practices offering the LAL and LAL+, as well as increasing uptake by patients, we believe we are establishing a new standard for premium IOL offerings in the U.S. Based on this momentum, we are even more committed to reaching the full potential of RxSight's unique adjustable technology and premium market opportunity. This includes expanding programs that enhance the clinical knowledge base of ophthalmologists, optometrists, and other eye care professionals, thereby leading to a better informed and served public. We believe that when patients understand the full benefits of adjustability, they are more likely to choose an LAL over a fixed lens alternative and thereby optimize their vision in ways that are meaningful to them. Reaching our full potential also includes maintaining our commitment to rapid innovation, exemplified not only by the recently commercialized LAL+, but also by ongoing advancements to the LDD and LAL insertion technology. In addition, we continue to believe that the success of the LAL in both the U.S. and Canada can be replicated in most major markets and look forward to building successful international programs, particularly in Asia and Europe, following regulatory approvals. Overall, we feel our strong first quarter results, along with a very positive reception at this year's ASCRS, further support our vision to make adjustability the standard for premium cataract and lens replacement surgery. With that, I'll ask the operator to open the call for questions.
spk16: Thank you. As a reminder, to ask a question at this time, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment while we compile our Q&A roster. Our first question is going to come from the line of Robbie Marcus with JPMorgan. Your line is open. Please go ahead.
spk07: Oh, great. Thanks for taking the question. Congrats on a very nice quarter. Two from me, maybe first to start. Volumes both in LAL and LVD were really strong in the quarter, but also so was pricing, if I do my math correct here. So maybe speak to what you're seeing in the field in terms of both adoption trends as you continue to place more than expected, LVDs and LVDs. I think that's a good utilization, but also on the pricing side because it continues to be robust for both of them. Thanks.
spk19: Okay. Why don't we start with Ron on the adoption trends and I'll follow up on the ASPs.
spk02: Yeah, I think that, you know, as you noted, Robbie, the adoption trends continue to be very positive. You know, we think that's a combination of the clinical outcomes with the LAL and now the LAL Plus, as well as the continued focus of our customer base on the premium IOL market and the potential to offset, you know, the revenue losses that they're seeing in their reimbursed areas. So overall, you know, we anticipate continued strong adoption, and with that, you know, we've been able to maintain good pricing discipline.
spk19: Thank you, Ron. And as you were calling know, Robbie, in the third quarter when we introduced the newer LVD, we increased our price by about 10%. And at that time, and again at year end, we felt like the ASP would continue to hold through going into 2024. We certainly saw that in the first quarter. The ASP was up about $3,000 as compared to the fourth quarter. I don't think it's any particular, you know, item that increased that as much as mix of customers, how large they are, whether it was the second or third LVD. And, you know, again, I think really good pricing discipline from our sales force bolstered by the fact that the results are, you know, excellent clinically and that we have more and more references
spk18: for new doctors to go to.
spk07: And great, maybe as a follow up, I wanted to talk about the competitive environment. By my math, they're closing in on 10% or so of the premium IOL market. You know, I imagine that's a pretty disruptive mark as you look at your competitors. You're starting to take larger shares and, you know, not just some early adopters, but hitting more of the mass market appeal. What, if anything, are you seeing in terms of a response from your competitors? And how do you feel about your ability to continue to grow and take share as you're moving up the adoption curve? Thanks a lot.
spk02: Well, you know, I would say that as we've noted before, a significant percentage of LAL cases, you know, are coming from patients who otherwise would not have selected a premium IOL. And because of that, you know, while some of our numbers are coming from other competitors in the premium space, a very large percentage are coming from either standard monofocal IOLs or toric IOLs, which tends to have less focus than the presbyopia correcting IOLs. So, you know, I think that, you know, that may not generate as much interest as, you know, as the 10% number that you quoted might otherwise. Shelly, do you have anything you want to add?
spk19: No, I don't think so. I think that people are taking notice of us. Certainly at ASCRS, we had, you know, you should talk about just kind of the booth traffic we had, as well as the number of presentations we had in the booth and number of papers presented at ASCRS. I think that certainly, you know, has led to higher visibility for
spk02: us. Absolutely. You know, I think that we're, you know, there are more and more practices that are using the technology and getting excellent results, and that word travels. But in terms of, you know, competitors, you know, I think that they've been aware of our excite for some time and will continue to follow it.
spk14: Thanks a lot.
spk16: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Ryan Zimmerman with BTIG. Your line is open. Please go ahead.
spk05: Good morning and or afternoon, excuse me, too many earnings calls. I just want to ask about a couple things. So, you know, the install base now is past 700. You've had a number of units in the field now for numerous years. As that install base grows, I'm just wondering if there's any service revenue considerations we should be thinking about. I would imagine that can start to grow and maybe, you know, step up a little bit over the course of this year and into 2025.
spk19: Yeah, I think that's a good question, Ryan. We do have a line on our P&L for service and accessories and it's exactly what you talk about, primarily service revenue. When we sell the LDD in accordance with GAP, we carve out about $7,000 out of the LDD revenue and ASP. And that is amortized over a year period into the service line. And in addition, we find about 80% of our customers when their one-year warranty expires take a service contract with us and the other 20% tend to use time and material. And so we should continue to see that line grow as our install base grows.
spk05: Okay. And then, you know, Shelley, margins were fantastic this quarter. Probably the, you know, most, I think, encouraging thing, you know, for long-term investors. You're guiding a little below 70%. You did over 70% this quarter, just a hair. You know, why does that regress in the rest of the year below 70%? Because, I mean, you're just on this fantastic trajectory with more LAL sold to drive margins higher.
spk19: Yeah, I think that the primary driver for margin in any given quarter is the percent of LAL, as a percent of revenue. In the first quarter, it was quite high because typically you see lower LDD sales, you know, capital sales, which we did. So I think that as you go through the next three quarters, we can see some different mix shifts as well. And of course, the LDD has a much lower gross margin than the LAL. And of course, as I mentioned, you know, we did have a nice ASP bump in the first quarter as well. That might be usual or unusual as well. And, you know, we've been able to roll in and lower material cost components more quickly than we had planned. But I think, really, the difference in any given quarter is going to be percent of LAL and percent of LDD.
spk06: Thanks, Michelle.
spk16: Thank you. And one moment as we move on to our next question. Our next question is going to come from the line of Patrick Wood with Morgan Stanley. Your line is open. Please go ahead.
spk13: Fantastic. Thank you for taking the questions. I guess the first one, you know, I know you guys don't split the guide down, but just qualitatively for LDD placements, would you expect that kind of similar growth that we saw year on year in LDD placements in Q1, would you expect that to be a similar kind of growth trajectory through the year? Or a bit of an uptick in that and a drop in the LALs? I'm just trying to work out roughly the passing of those two things out, even just qualitatively.
spk19: Yeah, qualitatively, of course, you know, the LAL grows much faster than the LDD. And that's to be expected, because our primary focus is not only just getting new customers, but getting new customers up faster, as well as continuing to penetrate in our existing customers and get them to continue to grow. So we have seen this shift between the LAL and the LDD. You know, the more install base you get, you know, you continue to get that. But in terms of breaking it out, I think kind of the general trends that we've been in for the last three or four years with LALs increasing much faster than LDD is indicative of what we want to do.
spk13: Makes sense. Thank you. And then again, qualitatively, of the LDD placements you've seen the last three, four, five months outside of things, you know, can you give us some sort of flavor how much of that is new accounts, existing accounts, buying a second system, just the, how that's trended over time very recently would be helpful.
spk19: Yeah, it's predominantly new accounts. And you know, what you see now a little bit is, I wouldn't call them repeat accounts in the following sense, because each sale is to an individual office, although the doctor or the underlying owners may be the same, right, because you're still selling to the primary doctors in the practice that want to pick up the LAL. Some doctors have, you know, two or three separate offices, they start in one, but then they might have different partners in their second and third offices. You see other people that are part of a larger network or a buying group, and each of those are individual sales. But I would say the vast majority are brand new customers to us that we haven't had in our installed base. There always are some that buy that we know, and they're really just expanding their footprint in their practices or in their network.
spk12: Brilliant. Thank you so much.
spk17: Thank you. And one moment as we move on to our next question.
spk16: And our next question is going to come from the line of David Sexton with Needham and Company. Your line is open. Please go ahead.
spk11: Hi, this is Joseph on for David. Just wanting to know how you guys are thinking about the competitive landscape, you know, with Odyssey and kind of an early launch and Panoptix Pro coming in the future.
spk02: Hi. Well, thank you. You know, I would categorize those competitive offerings as being part of the, you know, the fixed lenses that are very similar to other fixed lenses in the marketplace. And so, you know, while they may gain some attention at the end of the day, they're going to be compared against those more similar products than, say, the light adjustable lens. So, you know, we expect that the market will continue to see new offerings, but that the LAO will continue to have a unique set of benefits for patients.
spk11: Okay, gotcha. And then maybe just a quick one. Can you give some color around, you know, pre-cash flow profitability?
spk19: Yeah, I think that what you have seen is reduced cash use in each quarter as we've increased both revenue and gross margin. What you did see in this guidance is that we, you know, had a pretty big increase in our guidance for gross margin, but we also did increase OPEX a bit. And I think the increase in gross margin gives us an opportunity. We let most of those dollars fall to the bottom line, but we will continue to continue this balance between growth and gross margin in percent and absolute dollars with continued investment in OPEX. But I think we've been very careful in this guidance to balance both.
spk11: Okay, sure. Thank you very much for taking our questions.
spk16: Thank you. Thank you. And one moment for our next question. And our next question is going to come from the line of Tom Stephens with Stiefel. Your line is open. Please go ahead.
spk04: Great. Hi, everyone. Thanks for taking the questions. Maybe I'll start with LAL+. Could you maybe, I guess, qualitatively explain a bit how LAL+, was contemplated in 2024 guidance maybe in terms of the cadence of the rollout? I guess in other words, does guidance assume kind of a methodical ramp of LAL+, is it a fast ramp up, maybe somewhere in between? Any color there would be helpful.
spk19: Okay. You know, in terms of mix between LAL and LAL+, their price is the same amount at $1,000 per unit, right? And I think that for us, and Ron can comment on this a little bit more, part of the pricing strategy, of course, is that we want the doctor and patient to pick the ideal lens for them, knowing that both are adjustable. And we think that, you know, the results that we had in the first quarter are part of just our original guidance or strategy for the year with this concept of having two LALs in our product family overall. I don't know if you would comment on anything additional in that, Ron?
spk02: No, I mean, recall that the LAL+, was approved in 2023, and it was, you know, we had some initiated some initial phase four clinical studies in the fall. So, you know, we certainly had that in our minds developing 2024 guidance.
spk04: Got it. That's helpful. And then just my follow up, I guess on gross margin, Shelley, can you maybe level set us on where gross margins stand between your different products? Because when I run a low 30% gross margin on the LDD sales, I'm arriving at maybe 85% plus gross margin on the rest of the business. Are those fair places to be on both sides? And I guess I'm mainly curious about, you know, where LAL gross margin is tracking toward. Thanks.
spk19: Yeah, well, we don't break out both of them. Certainly, we've provided some, you know, information overall. As I've always stated, you know, our gross margin on the LDD, these people have equipment we try and get between 20 and 30%. As you go back into early 23, we were below the 20% or right at. Today, we are above the 30%, and what I would call well above overall. And, you know, just this, you know, little $3,000 higher ASP in the first quarter, you know, contributed to about a 2% increase in gross margin for the LDD. So we're trending a bit higher than we would otherwise. And I contribute that to one, a good pricing ASP discipline with our sales force, the value of the product, as well as the fact that we were able to roll in some lower material costs a little bit earlier. On the LAL side, we don't, you know, comment, but we believe that that product is, you know, in this kind of range, in the 80% something range, and probably likely over a very long time to become a 90% product. But that's a, you know, kind of way out there. You've got to get your volumes up for that to happen.
spk03: That's great. Thanks, Shelly. Thanks, Ron. Thank you.
spk16: Thank you. And one moment for our next question. And our next question is going to come from the line of Larry Beegelson with Wells Fargo. Your line is open. Please go ahead.
spk08: Good afternoon. Thanks for taking the question. So on the Q4 call, you said you'd be talking more about international markets later this year. And today I heard spending is going towards OUS clearances. And Ron, you spoke more about Europe and Asia in your prepared remarks today that I heard on the Q4 call. So my question is, does this imply you're closer to other major market launches? And what are you including in the guidance for OUS markets in 2024? And I had one follow-up.
spk02: Yeah, you know, I don't think anything's changed, Larry. We continue to focus, you know, primarily on the U.S. market. But we pursue our regulatory filings outside the U.S. in attractive markets. And we certainly will be updating as we make progress in those.
spk19: And I think as far as revenue goes in 2024, obviously we're in Canada. That has grown nicely for us and been a good market for us. I think in terms of the other markets, you know, these regulatory cycles are getting pretty long. For instance, in Europe, we've seen it longer than we originally anticipated and continues to get pushed out. And if we have anything, you know, outside of Canada internationally, I would expect in 2024 it would be pretty minor.
spk08: Got it. And, you know, one follow-up question for me, utilization, it looks like it was about 9.2 LALs per LDD per month in the first quarter and it grew about 5% a year. It looks like it's a little slower than what we've seen in the last few quarters. You know, why is that and how are you guys thinking about utilization for the rest of this year? Thank you.
spk19: So I think the difference between my numbers and your numbers is that we calculate the number of LALs per LDD by taking as the number of LALs over the number of LDDs installed at the beginning of the quarter, right? So you don't get a lot of normal LAL revenue out of new installs. But in fact, kind of if I look back, we were at 10.2 in the fourth quarter and we were at 10.1 in the first quarter, which I think is terrific overall. And kind of if you go back to, let's say, in Q4 of 2022, we were about 8.9. So I think that we've good sequential growth, although a little dip in the third quarter of 23 for Steve and
spk01: Alice. All right. Thanks, Shelley.
spk16: Thank you. And one moment for our next question. Our next question comes from the line of Steve Lichtman with Oppenheimer & Co. Your line is open. Please go ahead.
spk10: Thank you. Hi, Ron and Shelley. And congratulations. I wanted to ask, Ron, I think you mentioned targeting optometrists in terms of driving awareness. I think you talked to that at ASCRS as well. Can you talk a little bit about what that looks like in the field in terms of how you approach that and some of the potential benefits in terms of referrals and things like that from targeting that group? Thanks.
spk02: Yeah. So optometry is obviously a very significant part of eye care, particularly in the US, and are involved, integrally involved with cataract surgery, both in terms of counseling of patients preoperatively, as well as helping to manage patients through the course of their post-op periods. And that can be either independent or separate optometric practices that work in conjunction with ophthalmic offices, or it can be optometrists within ophthalmic practices. And we, you know, we obviously, for those practices that have our technology, many of them have optometrists, and we work very closely with them. Many of them have become very experienced and knowledgeable about our technology. They are often, you know, just as academically minded as the ophthalmologists and like to present at their respective meetings, and we see more of that, and we certainly want to support that. And then, you know, through our optometrists, in terms of optometrists, in their optometrists' optometristic and ophthalmic practices, we certainly want to support their educational events with optometrists in their community as well. And, you know, that's something that's important in driving awareness of the technology, which is very attractive just fundamentally to optometrists generally, because it fits with their overall ethos of quality of vision.
spk10: Great. And then just as a quick follow-up, are you adding to the sales force on the LDD side this year, and if so, how much are you increasing that?
spk19: Yeah, I think that if we look at our planned headcount ads, you know, they're primarily in our clinical applications and LAL folks who work closely with the LDD. We may add a few on LDD, but certainly not at the rate that we add to those two other groups.
spk09: Great. Thank you. Thank you, Steve.
spk16: Thank you, Steve. Thank you, and I would now like to hand the conference back to CEO Ron Kurtzwisk for closing remarks.
spk02: Well, thank you all for your time and attention today. We appreciate your interest in our XITE and look forward to updating you on our progress in future quarters. Goodbye.
spk16: This concludes today's conference call. Thank you for participating. You may now disconnect.
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