5/7/2025

speaker
Conference Call Operator
Operator

Thank you for standing by. At this time, I would like to welcome everyone to the RxITE First Quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to redraw your question, press star one again. I would now like to turn the conference over to Oliver Moravcevic, Vice President of Investor Relations. Please go ahead, sir.

speaker
Oliver Moravcevic
Vice President of Investor Relations

Thank you, operator. Presenting today are RxITE President and Chief Executive Officer, Dr. Ron Kurtz, and Chief Financial Officer, Shelly Tunin. Earlier today, RxITE released its financial results for the three months ending March 31st, 2025, and reiterated its 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 view as of today, May 7th, 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 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 place undue reliance of 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 non-GAAP financial measures can be found in the press release. Please note that this conference call will be available for audio replay on our investor relations website. With that, I'll turn the call over to our president and chief executive officer, Dr. Ron Kurtz. Ron?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Good afternoon, everyone, and thank you for joining us. As we discussed during our pre-announcement just over a month ago, the first quarter brought an unusual combination of macroeconomic headwinds and competitive disruptions that led to our first top-line miss since becoming a public company in Q3 2021. Although interest in our technology remains high as evidenced by continued strong LDD demand, we experienced a first-time -over-year drop in the LALs per LDD metric. I'd like to now share some of our recent analysis, which has helped us develop targeted programs focused on same-store procedure growth while also continuing to develop the broader opportunity via the addition of new customers and markets. Unsurprisingly, the vast majority of respondents to our customer survey conducted in early April cited negative macroeconomic headwinds as the key reason for reduced LAL procedure volumes in Q1. These findings are consistent with preliminary reports from third-party data aggregators that also suggested reductions in overall cataract procedures and trade-downs to lower-priced premium procedures. Given that approximately 75% of LAL patients are drawn from candidates who would otherwise consider lower-cost options like monofocal or toric lenses, it's not surprising that LALs were also affected by temporary negative wealth effects and uncertainty. While macro trends worsened in early April, there were signs of improved stabilization later in the month, which were also observed in our procedure volumes. Competitive trialing was also commonly cited by customers with many commenting that the major multifocal offerings were now essentially equivalent across manufacturers. Even though we expect these competitive pressures to persist over the next several months, we also believe they signal an opportunity for the LAL to offer a compelling alternative to what is rapidly becoming a plethora of undifferentiated multifocal offerings. Finally, even though almost all practices expressed a desire to expand their LAL and LAL Plus volumes, workload challenges and a desire for additional clinical and marketing guidance were also noted. To address this, we are refining our clinical education and marketing support to better meet existing practice and doctor requirements to drive procedure growth. As we invest in these efforts, we also remain focused on advancing innovation to drive greater clinical value and customer engagement. We are pleased to share that we are ahead of schedule in launching a previously announced software update that includes both a unique spherical aberration treatment option, as well as new LDD procedure monitoring features, both of which support our enhanced clinical education and marketing efforts. While the ability to customize spherical aberration and other so-called higher order aberrations has been available in corneal refractive surgery for nearly two decades, this new LDD capability represents the first such application in cataract surgery, opening the door for further improvements in clinical results compared to fixed IOL technology. Although perhaps less groundbreaking, the additional LDD procedure monitoring features provide surgeons with new tools to ensure adherence to best clinical practices. Such upgrades enable us to not only to reconnect with our customers and showcase new functionalities, but also deepen relationships, identify growth opportunities within existing practices, and embed our technology more fully in their clinical workflows. Looking ahead, our product innovation pipeline remains robust. Recently, we secured approval for very low diopter LAL powers that will now match those already available for LAL+. We look forward to continuing to develop the LAL family of lenses, along with continued software and LDD enhancements that broaden the patient populations that can benefit from customized visual outcomes. We believe these innovations are also key to enhancing productivity at new customer sites, as surgeons and practices are more likely to recognize our site's adjustable technology as a significant long-term growth driver. By capturing these strategic placements promptly, our site ensures a strong foundation for sustained future growth, while the practice sees faster revenue and practice appreciation. Though these placements have traditionally been to individual offices, we are also encouraged by the growing third-party light treatment service center business models that those still modest contributors to our total procedures have significant potential to expand access and utilization of our technology, ultimately benefiting more surgeons and patients. On the international front, we recently received full regulatory approval for our LAL, LAL+, and LDD products in South Korea, a market we believe can become highly engaged with our technology. Additionally, following last month's announcement of EU LDD and LAL approvals, we now expect UK approval in the second quarter and have multiple additional international regulatory submissions in process. As always, the near-term focus remains on delivering excellent clinical outcomes, laying the groundwork for expanded commercialization both internationally and in the US. With that, I'll turn things over to Shelley to take us through the financial results for the quarter and reaffirm guidance.

speaker
Shelly Tunin
Chief Financial Officer

Thank you, Ron. Good afternoon, everyone. Consistent with our April 2nd, 2025 pre-announcement, our excite generated first quarter 2025 revenue of $37.9 million, up 28% compared to the $29.5 million in the year-ago quarter, and down 6% compared to $40.2 million in the fourth quarter of 2024. During the quarter, we sold 27,579 LALs and generated $27.2 million in LAL revenue, up 37% compared to the first quarter of 2024, and down 5% compared to the fourth quarter of 2024. In the first quarter of this year, LAL revenue represented 72% of total revenue, and increased from 67% and 71% in the first and fourth quarters of 2024, respectively. During the first quarter of 2025, we sold 73 LDDs, up 11% compared to the 66 units in the year-ago quarter. On a sequential basis, our LDD units sold during the first quarter were down 12% compared to the seasonally strong capital equipment in the fourth quarter with the sale of 83 LDDs. During the quarter, LDD sales generated revenue of $9.4 million, up 8% compared to the first quarter of 2024, and down 12% versus the strong fourth quarter of 2024. As of March 31st, 2025, our LDD install base stood at 1,044 units, up 43% and 8% versus the first and fourth quarters of 2024, respectively. Gross margin in the first quarter of 2025 was 74.8%, compared to .1% and .6% in the first and fourth quarters of 2024, respectively. The increased gross margin was primarily due to lower LAL costs and mix. Because we can sign LAL inventory, we recognize the LAL cost of goods sold about nine months after we build product. Throughout 2024, we ramped up production to stock LAL plus inventory at ASCs. Because most of the LAL cost is fixed overhead, the higher volume production benefited gross margin at the end of 2024 and the first quarter of 2025. In addition, the shift in product mix benefited first quarter of 2025 was a higher margin LAL revenue advancing to 72% of revenue from 67% in the first quarter of 2024 and 71% in the fourth quarter of 2024. SGMA expenses in the first quarter of 2025 were $28.6 million, representing an increase of 5.3 million or 23% versus 23.3 million dollars. In the year ago quarter, this year over year increase was primarily due to an increase in personnel costs, expanded collection of registry data with the full rollout of LAL plus during 2024 and increased stock-based compensation expense. On a sequential basis, SGMA expenses increased 2%, primarily due to higher personnel costs. During the first quarter of this year, R&D expenses rose 29% to $10.4 million compared to 8 million in the first quarter of 2024. This year over year change primarily reflects an increase in salaries and stock-based compensation. Compared to the fourth quarter of 2024, R&D expenses in the first quarter rose by 13%, also primarily driven by increases in salaries and stock-based compensation. We reported a gap net loss in the first quarter of 2025 of $8.2 million or a loss of 20 cents per basic and diluted share using weighted average shares outstanding of 40.5 million shares. This compares to a gap net loss of $9.1 million or 25 cents per share on a basic and diluted basis in the first quarter of 2024. Note also that stock-based compensation in the first quarter of 2025 was $7.1 million, resulting in a non-gap loss of $1.1 million or a loss of three cents per basic and diluted share. Please refer to the unaudited non-gap reconciliation and disclosure included in today's press release for more comparative information. We ended the quarter of 2025 with cash, cash equivalents and short-term investments of $229.3 million compared to $207.2 million on December 31st, 2024. First quarter cash use is generally high as our employees earn a portion of their compensation in performance-based bonuses, which are accrued during the year and paid in the first quarter of each year. Moving on to our 2025 outlook, we are reiterating our full year 2025 guidance for revenue, gross margin and operating expenses that we provided on April 2nd as follows. Revenue of 160 to $175 million, implying -over-year growth of 14 to 25% and assuming recovery of LAL volumes in the second half of the year. While the early signs of stabilization, April, along with our continued clinical and marketing efforts as described by Ron, are encouraging, we expect macroeconomic pressures and competitive trowelings to persist through the second quarter with stronger recovery and LAL procedure volume anticipated in the second half of 2025. Gross margin of 71 to 73%, representing an applied increase of 30 basis points to 230 basis points compared to 2024. We are maintaining our gross margin guidance of 71 to 73%, despite gross margin of .8% reported in the first quarter because a significant portion of our LAL cost of goods sold is fixed, the anticipated benefit to gross margin from higher production, LAL volume in 2025, will now be reduced given the revised revenue outlook. Operating expenses of 150 to $160 million, representing an increase of 10 to 18% over 2024. As Ron already indicated, our spending will be centered on strengthening our clinical education and marketing programs to better support practice needs and drive higher LAL procedure adoption and continued investment in R&D. Note that the operating expense estimate includes non-cash stock-based compensation expenses between 27 and $30 million. While our guidance includes targeted investments aimed to support and reinvigorate LAL procedure growth, we continue to be committed to carefully managing operating expenses. With $229.3 million in cash, cash equivalents and short-term investments, we remain well-capitalized and our strong cash position supports our continued progress toward cash flow breakeven. And with that, I'll turn the call back to Ron.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Thank you, Shelley. We believe that the actions we have and will be taking position us to reaccelerate LAL growth, which has been mostly responsible for expanding the premium IOL category over the past several years. The ability of our differentiated technology to meet the needs of doctors and patients was on full display at the recent meeting of the American Society of Cataract and Refractive Surgery, which also provided us with a timely check-in with many of our current and future customers. Both in the scientific sessions and on the exhibitor floor, the more than 40 physician presentations and two numerous to count informal references to the light adjustable lens strongly reaffirmed the distinct position our technology continues to hold within the premium IOL market and within cataract surgery more broadly. While there were many highlights for the LAL and LAL+, we noted a study by Lee et al. that retrospectively compared visual outcomes of cataract surgery in over 150 patients implanted with either the LAL or LAL+, or a multifocal IOL at a large academic ophthalmology department. While about three times as many LAL and LAL+, patients had had previous corneal refractive surgery compared to the multifocal group, both binocular distance and near visual acuity without glasses was found to be statistically better with an adjustable lens, with more than twice the number of patients attaining 20-20 distance and J1 reading vision than with the fixed multifocal IOL. When coupled with the growing body of data now being collected and experienced by numerous clinicians, these results in the overall excitement and engagement we observed at the meeting reinforce our conviction that the precision and customization afforded by post-operative adjustability are shaping both the present and future of premium cataract surgery. In closing, although the first quarter presented meaningful challenges that may persist in the near term, our confidence in Rxcite's long-term growth trajectory remains unwavering. We believe the premium IOL market is undergoing a structural shift with commoditized fixed IOLs competing in a relatively stagnant market while our differentiated customized solution drives expanded premium volumes and in turn greater search and focus. As we move through 2025, our team remains highly focused on executing our plan, energized by the opportunity ahead and committed to delivering lasting values for patients, surgeons and shareholders alike. With that, I'll ask the operator to open the call for questions.

speaker
Conference Call Operator
Operator

Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. And we do request for today's session that you please limit to one question and one follow-up. Thank you. Your first question comes from the line of Ryan Zimmerman with BTIG. Your line is open.

speaker
Ryan Zimmerman (via Izzy)
Analyst, BTIG

Hi, Ron and Shelley. This is Izzy on for Ryan. Thanks for taking the questions. I was hoping to start out discussing the pacing and scale of your Redouble Commercial efforts. I was curious when we might start to see contributions from these start to pay off.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Yeah, I think as we discussed, taking into account the macro environment and the competitive trialing, we expect those to be in the back half of the year that we would start to see impact from those.

speaker
Ryan Zimmerman (via Izzy)
Analyst, BTIG

Understood, thank you. And as we think about the broader macro environment, I understand that the focus is still on the US, but I was curious how you're thinking about the pacing or the timing with which you want to expand internationally.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Yeah, I don't think that the macro environment impacts our pacing internationally, which obviously is initially focused on continued regulatory approvals and then initial market experience. We're starting from such a low base that we wouldn't expect to see significant impact from the macro environment, except for there may be special cases in certain markets that we'll stay attuned to.

speaker
Conference Call Moderator
Moderator

Understood, thanks for taking the questions. Your

speaker
Conference Call Operator
Operator

next question comes from the line of Fiong Lee with Jeffries. Your line is open.

speaker
Fiong Lee
Analyst, Jeffries

All right, great, thanks for taking our questions. I guess I wanted to ask a little bit about the comments you made on April. It sounded like early April trends were still pretty choppy and rough, but it got better later on. Can you maybe talk a little bit more about what you're seeing in more recent periods?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Yeah, I don't think I would go too far beyond what we've already commented. I think that obviously April was, there were a lot of things going on at the macro level in April, but overall those by the end had roughly stabilized, and that was something that we also saw in our numbers.

speaker
Shiloh
Company Representative

You want to add anything, Shiloh? All right, great, that's very helpful.

speaker
Fiong Lee
Analyst, Jeffries

I guess I wanted to ask a little bit about the guidance. There's a lot of moving parts here with competitive trial and two-queue dynamic versus second half. Is there any incremental colors you can provide on the quarterly payments for the two-queue? The rest of the year?

speaker
Shelly Tunin
Chief Financial Officer

Yeah, we don't give quarterly guidance just annual, and we don't break it out by LAL and LED, but I think what we have said is we would expect the number of LEDs that we sell during the year to continue to be higher than 2024. And typically, the second quarter is a very strong quarter for us seasonally, but with everything going on with macroeconomics, trialing and whatnot, what we are cautioning investors to keep in mind is the environment is so much different than it's been in past years, and that we expect the LAL volume mostly to increase in the second half of the year, and that just represents a transition, hopefully, out of this kind of macroeconomic environment and the uncertainty around it as patients get more certain about how the economics are gonna affect them personally, and that makes a difference as well as the fact that we have to give time for some of the new marketing initiatives we're using to help our customers sell in this kind of environment, and also to, we'll have opportunities, as Ron said, to touch customers as we do our new software upgrade. It has some really nice features. It gives us an opportunity to come in and train and offer value to our customers as we do that, and that always has some benefit to us. Would you add anything to that, Ron?

speaker
Shiloh
Company Representative

No, thank you. Thank you very much.

speaker
Conference Call Operator
Operator

Your next question comes from the line of Patrick Wood with Morgan Stanley. Your line is open.

speaker
Patrick Wood
Analyst, Morgan Stanley

Beautiful, thanks, guys. Two quick ones. First, I'd love to dig in a little bit more on the workload challenges that you mentioned. You know, is, because I would have thought, like, the premium IOL side dropping a little bit, might have freed up a little bit of consultation time. So, like, what is it that's eating up the time for the customers so much that you're speaking to? What's kind of blowing out that time that's making things hard at the moment?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

I just want to clarify, Patrick, you said the workload challenges, right? Yeah. Yeah. So, you know, I think that this is not necessarily something that's brand new. It's something that's been going on for a while, just staffing challenges in practices that, you know, that we certainly picked up in our survey. And that, you know, that's going to be a little bit practice to practice dependent, but that was definitely one of the items that we saw in the responses to our survey. And so that's really what we were referring to.

speaker
Patrick Wood
Analyst, Morgan Stanley

Gotcha, that's handy. And then just as a quick follow-up, for the H2 macro factors getting better, I mean, what was the sort of thought process in embedding that within the guide? I mean, is it more that you can engage with the customers more so you can, you know, pull things around that side? You know, why, and not another sound sort of provocative, but why would we expect that sort of -year-old cohort to feel much better about the world in the second half relative to first?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Thanks. Well, I don't know that we're necessarily expecting that they're going to feel that much better, but I do feel that there's some normalization that probably has already occurred to some extent. Remember, cataract surgery is something that, you know, patients generally can put off for a little bit of time, but ultimately they're going to have to do something. And, you know, one of the things that we try to emphasize and will continue to do so is that this is an investment that is for that person's rest of their life, and that, you know, there's not many things other than vision that can have a direct impact on so many aspects of the quality of life. So, you know, we anticipate that over time that will become more apparent, even if, you know, we don't see a wholesale turnaround in the macro environment.

speaker
Shiloh
Company Representative

I gotcha. Thanks, Ron. Thanks, guys.

speaker
Conference Call Moderator
Moderator

Your next question comes

speaker
Conference Call Operator
Operator

from the line of Steve Lichman with Oppenheimer. Your line is open.

speaker
Steve Lichman
Analyst, Oppenheimer

Thank you. Ron, you mentioned workflow and wanting to support your customers through education and other marketing initiatives. Can you talk a little bit more about what that entails?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Yeah, so, Steve, you know, we've learned a lot over the last, you know, four and a half years of commercialization, and, you know, to some extent we've been able to disseminate that knowledge to our customers, but we still see gaps, and we think that we can do an even better job of translating all the pearls that, you know, you learn when you develop, when there's a new technology, a new, really a new clinical capability that hasn't existed before. There are many subtle things that are either clinical pearls or practice pearls that have to be first learned and then disseminated, and we continue to collect those and are now taking the opportunity to, you know, more fully compile them in a format that our customers, who may not all have made use of them, can to be able to be applying those best practices.

speaker
Steve Lichman
Analyst, Oppenheimer

Got it, got it, that's helpful. And then just as a follow-up, you know, the strong gross margin, you know, for the year, and understanding the cadence, Shelley, but for the year, as well as the balance sheet suggests, you've got some flexibility on OPAC's reinvestment. So any thought about adding more sort of feet on the street or anything else in terms of being even more aggressive, especially in light of sort of the competitive trialing environment?

speaker
Shelly Tunin
Chief Financial Officer

No, I think it's a good question. We have right-sized the OPACs to the size of revenue, right, at the low end, and I think one of the things that we did is we did not drop as much of the gross margin impact to the bottom line as we did in, as a percent, as we did in our initial guidance when we expected revenue to be higher. I think that, you know, if we can continue to, you know, make progress, particularly in the second half, that any kind of additional reinvestment would be in sales and marketing. I think that the R&D line is pretty fixed to where we're expecting right now, but if we could put more into sales and marketing, we saw the benefit from that, we would as well. I wouldn't expect us to put more money than we budgeted into the international side, just because in the initial phases of an international introduction, it's very focused on key opinion leaders.

speaker
Steve Lichman
Analyst, Oppenheimer

Makes sense. Thanks so much.

speaker
Conference Call Operator
Operator

Your next question comes from the line of David Saxon with Needham and Company. Your line is open.

speaker
David Saxon
Analyst, Needham & Company

Great, good afternoon, Ron and Shelley. Thanks for taking my questions. Maybe I'll start with you, Shelley, on the P&L. So gross margin, almost 75%, obviously really strong. Can you quantify the benefit you saw from the volume leverage? You know, as a result from the LAL Plus production last year, I guess, do you think some of that benefit might spill into the second quarter? And then just given kind of the back-end waiting of the year and the guidance, I guess, why wouldn't you see similar volume leverage for the full year, assuming that cadence plays out?

speaker
Shelly Tunin
Chief Financial Officer

Yeah, I think that's a really good question. We'll see some spillover into the second quarter, but I think the most important part of our guidance relative to the first quarter actual results is that we increased production a lot to stock the ASCs in 2024. Had we kept at our initial guidance, you know, with a higher revenue number, we probably would have produced to fulfill both orders as well as increases to new customers in their ASCs. At probably a pretty comparable level, but we're also reducing the production this year in 2025, and we started that at the end of the first quarter to recognize one, we wouldn't sell as much during the year, and also we went into the year, right, because you've got to have inventory with a little bit, with an inventory consistent with our original guidance, so we cut back to that as well. But I think that that will primarily be affected in the third and fourth quarters where you see the lower gross margins to come between the 71 and 73%.

speaker
David Saxon
Analyst, Needham & Company

Okay, that's helpful. Thanks for that, Shelley. And then on international congrats on South Korea, looks like UK's in the near term, so can you quantify the premium IOL volumes in those markets? I think the US is around a million. Would love to hear what the combined South Korea, UK, and you can throw Europe in there. And then I guess, how are you thinking about tariffs as you prepare to launch in those regions? Thanks so much.

speaker
Shelly Tunin
Chief Financial Officer

Yeah, I don't have those numbers off the top of my head, but Oliver could certainly pull those. I would say typically in the OUS market that premium volume as a percent of total cataract surgery is closer to 10%, but higher in these specific countries. But that would be a follow-up we'd need to do. I'd need to pull some reports to get that to you. But the reason we think about these regions are really about their potential as much as anything else. Among the 20 countries or so that we think have potential value, number of good countries in Asia, Korea is certainly one of them as well, and Japan, China ultimately, and a few smaller countries within the EU, predominantly in Germany, which is very strong. For premium, it would be Spain, Italy, France, and then of course UK that are the most penetrated and where we'll start our penetration. And I think that one of the things Ron always says to me, and I'll let him talk about that, particularly when he's in Asia, the AFCs and the doctor's offices are just superb and they're very, very focused on quality. And I think that's very important because that's what we offer to customers. Would you add anything about that, Ron, at all?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Yeah, I think that, again, ophthalmology is an international field. It's very similar across the developed world in Asia and Europe. Specifically, South Korea is a little bit smaller market than overall in cataracts than Canada, but has been, there've been some ups and downs in the market due to changes in some of the reimbursement rules in the last several years. But overall, it's a very strong private pay market in a number of fields, and we think that there'll be a lot of interest in the LAL there. Similarly, Europe is a large market overall. Total cataract market is somewhat larger than the US, but the premium market has been smaller, as Shelley mentioned, and we'll take a targeted approach there.

speaker
David Saxon
Analyst, Needham & Company

Okay, great, thanks so much. And then, just on the tariff, part of the question, will the LAL and LVDs be exempt, or is there some impact there? Thanks so much.

speaker
Shelly Tunin
Chief Financial Officer

Yeah, we did have our tax accountants look at Canada, because we're currently selling into Canada. Like very often, pharmaceuticals and medical devices are exempt. Now, of course, with the administration coming in and saying that pharmaceuticals coming in from China are gonna be subject to taxes coming into the US, I don't know about other countries yet, and of course, it is a back and forth number whether any country would have a retaliatory tariff on med device and on pharma. But where we're going so far, our products have been exempt from

speaker
Shiloh
Company Representative

tariffs.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

And of course, on the other side of the tariff equation, we produce everything in the US, and most of our suppliers are also in the US. Yeah,

speaker
Conference Call Operator
Operator

thank

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

you.

speaker
Conference Call Operator
Operator

Your next question comes from the line of Edam meter with Piper Sandler, your line is open.

speaker
Edam Meter
Analyst, Piper Sandler

Hi, good afternoon, thank you for taking the questions. Two from me, just one quick one on international, and just wondering if there's any update, Ron or Shelley, in terms of the commercial strategy for those geographies, will you be going direct or partnering with the distributor, and then add a follow-up, thanks.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

So that's a market by market decision. Some markets, including South Korea, require a distributor, and so we do have one. The other markets where there's not will make the decision whether we'll be direct or not. Currently, we use a distributor in Canada.

speaker
Edam Meter
Analyst, Piper Sandler

Okay, that's helpful, Ron, appreciate the color. And then for the follow-up, I'm admittedly newer to the story, but I just wanted to level set on the freestanding LDD treatment center initiative that you guys have. When did the initiative start? How far along are you in terms of number of sites or customers that use the option, volumes that come from those freestanding sites, and just how you think about some of those metrics trending going forward? Thank you for taking the questions.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Sure, so actually, the idea of, of treatment centers for offering LDD services, again, these are third parties. That idea has been around for several years, and there have been a few successful ones, more individually based in certain regions. I would say it's caught more, as our market awareness has grown about the light adjustable lens, then certainly there's been more interest amongst surgeons on figuring out how they can get access if they wanted to not necessarily purchase an LDD or offer the light treatment centers in their own clinics. And there can be various reasons for that, and certainly we saw in, we've seen in other areas of ophthalmology, specifically LASIK, where center models have been successfully implemented. So currently, there are several efforts out there, and we're certainly working with them and see them as good partners, but it's still early in the rollout, but we do see there's some natural advantages for certain customers, and we see this as a promising area.

speaker
Shiloh
Company Representative

Thank you.

speaker
Conference Call Moderator
Moderator

Your next question comes

speaker
Conference Call Operator
Operator

from the line of Robbie Marcus with JPMorgan. Your line is open.

speaker
Robbie Marcus
Analyst, JPMorgan

Oh, great. Thanks for taking the questions. Two for me. First, Shelley, I just wanna make sure I heard you right. I think you said second quarter will be below the low end of the range. Does that mean we're looking at something less than 38 million in sales in 2Q?

speaker
Shelly Tunin
Chief Financial Officer

Oh, I didn't get that specific at all. I didn't give guidance on the second quarter. What I did say is that as we go through the year, I would expect second quarter to not be the type of quarter we typically seen with a big uptick, and that most of the growth on the LAL side would happen in the second half. What Ron did say is that we saw encouraging signs as we exited April in terms of volume getting lower. And so I'm just being cautionary on the second quarter, just given the macroeconomics and some market turmoil and giving us time for consumers to not necessarily, they haven't been harmed, but people tend to stand still until they know how something is gonna affect them. So we think more of that will happen in the second half and also that trialing will start to abate in the third quarter.

speaker
Robbie Marcus
Analyst, JPMorgan

Great, appreciate the clarification. Then maybe just to continue on that thought, what makes you think that trialing will abate in third quarter and sales in the macro will pick up? Just simply you have Bausch and Lomb who's reentering the market after a pause. I imagine they'll sample for a while, Alcon's launching. Why wouldn't it continue for a long time? And given the lower guidance, do you think it's prudent to assume a stoppage in third quarter?

speaker
Shelly Tunin
Chief Financial Officer

So Ron, why don't you start and then, I think I said to abate but not absolute stoppage.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

I mean, I think we're in a, we've sort of exited an arrow when there was a single player that dominated the market. We now have multiple players with, in terms of fixed IOLs, particularly multifocal IOLs that have very similar offerings. And we anticipate that that'll return to what used to be the case where there was more competitive back and forth. But recall that three quarters of our volume for LALs comes from non-multifocal IOL patients, patients who would have other guys gotten a monofocal or a toric lens. And so we would, again, we're not ignoring that there will continue to be competition and that there is gonna continue to be a more complicated macro environment. But we think that it won't be quite as dramatic as what we saw over the last six to nine months when we had that pretty dramatic change in what had been existing in the premium

speaker
Shiloh
Company Representative

space. Great, thanks Ron.

speaker
Conference Call Moderator
Moderator

Your

speaker
Conference Call Operator
Operator

next question comes from the line of Larry Biggleson with Wells Fargo, your line is open.

speaker
Larry Biggleson
Analyst, Wells Fargo

Good afternoon, thanks for taking the question. I think, Ron and Shelley, I think what a lot of people are trying to understand is how de-risk the updated guidance is. So from my question, you did 28% growth in Q1. You talked about, and your Q4 call was in late February. So March, it seems like it really deteriorated. And you said April actually worsened before it stabilized. So are you willing to give us any color on how March and April were relative to, call it the guidance range or the midpoint of the Q2 to Q4 guidance, which is 17% or so implied. Any color on where March and April were relative to the updated guidance range? And I had one follow-up.

speaker
Shelly Tunin
Chief Financial Officer

Yeah, so I'll start with March and then make a commentary that you made about April. In March, what we saw is that typically March approaches or is at 45% of the total volume for the first quarter. And you see that uptick in March as you lead into the seasonally strong second quarter. We didn't see that March. It wasn't any worse than January or February. It was certainly up a bit. And that, but it was more a third, a third, a third. And that was kind of one of the things that was unexpected in the first quarter as well. Of course, a lot more turmoil economically and macroeconomically in that March time period. I didn't say that April was worse. What we said is April, and maybe I misspoke, but we saw recovery in the second part of April, toward the end of April. So it was better than March, right? But we saw that more in the second half of April rather than in the entire quarter, right? So I think that that was positive as well. In terms of our overall guidance, if I think about the low end of the guidance, and I'm just gonna provide two bookmarks, the low end of guidance, even though we're expecting more LED sales, which I think is very positive, the way I thought about the low end of guidance when we gave it is that we would sell more LEDs, but the same store sales would remain relatively stagnant to the first quarter, which we haven't seen that so far, so that's good news. And that most of the LAL increase in volume would come from newer customers, people who were installed in the second half of 24 and installed in 2025. So that's kind of that end of the bookmark. As we go through to the high end of the guidance, what we hope to see is two things. One is that consumers get used to the turmoil, or maybe it even ends, and therefore they have more confidence in upgrading to a premium IOL rather than staying with the monofocal or even a toric. And so that is certainly a part of it, as well as the fact that the competitive pricing on the premiums in terms of trialing can't go on forever, right? So that is one of our premises as well, and that we continue to see that in part because at some point in time, doctors will realize that, as Ron said, the multifocal IOLs are not all that different from each other. And the reason is they go to less and less multifocality as they introduce new products. And that cuts down on the glare and halo, but they're all moving in the same direction as well. Would you add anything to that on trialing,

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Ron? No, again, I think this is something that we've seen over the years in the field, and there is this waning that typically is in about the six-month timeframe, so that's within the timeframe that we've discussed.

speaker
Larry Biggleson
Analyst, Wells Fargo

All right, I'll leave it there. Thanks so much for taking the question. Thank you.

speaker
Conference Call Operator
Operator

Your next question comes from the line of Craig Bichoux with Bank of America. Your line is open.

speaker
Craig Bichoux
Analyst, Bank of America

Good afternoon. Thanks for taking the questions. Just one from me. And I appreciate the comments on the LDDs, and you still expect LDD growth or LDD placements to be above 24 in 25. But I wanted to get a sense for, have you heard or have you had discussions with some of the practices that are in your funnel thinking about purchasing an LDD? And if they have any concerns on a softer premium IOL market and whether that could have some impact on the timing or maybe the deferral of purchasing an LDD until they see that pick up?

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Well, I guess the way I would answer that would be that while that's certainly a possible reaction, it's given that a large fraction of the LAL patients come from non-premium. If you wanted to grow your premium, not adopting the LAL would be the opposite of what you would want to do. So we think there's a strong rationale to actually adopt the technology now and take the opportunity of perhaps a softer market to incorporate that into your practice.

speaker
Shiloh
Company Representative

Okay, thanks for taking the question. Thank you.

speaker
Conference Call Moderator
Moderator

Your

speaker
Conference Call Operator
Operator

next question comes from the line of Tom Stephens with TFL, your line is open.

speaker
Tom Stephens
Analyst, TFL

Great, hi everyone, thanks for the questions. I'll start with a big picture question. I know there's obviously a lot of macro and competitive factors, but the main investor concern we hear right now is if the US could be nearing or approaching some sort of saturation point. Ron or Shelley, your reaction to that or thoughts to that, maybe notably given, Shelley, I think you've said the class of 2024's adoption curve has been a little slower than prior classes. Maybe if you can talk about that.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

So I just wanna make sure I understand the question, Tom. You're talking about reaching a ceiling for LAL?

speaker
Tom Stephens
Analyst, TFL

Correct, LAL either on a per surgeon basis or adoption kind of within the context of the 10,000 cataract surgeons in the US. Either or, kind of just big picture.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Yeah, again, I just don't have, I don't see a good argument for that based on the overall penetration of the technology. We're currently sitting at maybe somewhere between 10 and 12%. There are many, many, many surgeons, I would say even most, who are just getting familiar with the LAL and the potential. So while I understand the concern, I think that that's still something that is gonna be in the later years. I think there are better ways that we can certainly address the market. We've talked about some of them. Some of those doctors are gonna be better addressed through an open access model. And some of them will be more traditional methods. But this is the best, premium IOLs are the best way for practices to resist the continued negative onslaught of reimbursement cuts that they're seeing in all other aspects of their practice. And the LAL has been the primary mechanism for growing premium overall. So I still see that in play for a long time to come.

speaker
Tom Stephens
Analyst, TFL

That's helpful, thanks Ron, appreciate that. And then pivoting to the pipeline, know you keep it pretty close to the vest, but just wanna ask what your view is on both a multifocal LAL and an accommodative LAL. I guess my question is are these feasible technologies to begin with when considering, I guess the base adjustability technology with LAL? Thanks for the questions.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

I mean, again, I think that adjustability affords benefits for all types of IOLs. And my view, and I think I've said this before, is that I think that the precision and customization that adjustability enables is something that will become if not a requirement, a very strong preference for any time in the premium space where patients have the ability to upgrade for technology. So in that context, and as we've already kind of done with LAL Plus and some of our expansions into the different power ranges, we're developing a family of lenses. And where that takes us is gonna be guided by surgeon input and financial opportunity. Certainly, multifocals have a strong place in the market and accommodating IOLs have a strong interest in the market. And I think we've seen other efforts towards accommodating IOLs recognize that in order to have a practical accommodating IOL, you likely need to have a adjustable IOL first. So I would, we have a long runway of product pipeline activity for this technology. I'm certainly beyond my career. And I think that all the things that you mentioned are certainly possible.

speaker
Shiloh
Company Representative

That's great. Thanks, Ron. Thanks, Shelly.

speaker
Conference Call Operator
Operator

Your next question comes from the line of Angela Khomeeri with the UBS group. Your line is open.

speaker
Angela Khomeeri
Analyst, UBS Group

Hi, thank you for taking our question. I'm on for Danielle. So mine is just a follow up on Larry's question. You say to stay in the much more concerns about what you find the sound of the court's revenue. And that is usually a good proxy of the round to two two, but that is not something that you saw this quarter. So I was just wondering, appreciating your comment on signs of improving stability in April, what level of visibility do you have into customer case schedules? Just want to get a sense of your confidence in being able to reach your renewed guidance. And then I have one follow up.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

So I just want to restate your question, Angela. So you're asking, how do we have visibility into April numbers? Is that what your question is?

speaker
Angela Khomeeri
Analyst, UBS Group

Yes, two

speaker
Shelly Tunin
Chief Financial Officer

Q

speaker
Angela Khomeeri
Analyst, UBS Group

numbers.

speaker
Shelly Tunin
Chief Financial Officer

Okay, so obviously, because we can sign inventory, it's reported to us when the implant is made into the patient. So we see those usually within a few days of implant as they get reported to us. We don't have visibility into a particular doctor's schedule. So we don't know what they have planned for the balance of the quarter, but we try and use some historical data, but we have stopped using it given our unique circumstances as well. And as we said, the low end of the guidance assumes virtually no recovery in same source sales. The higher end of the guidance obviously does so. And the only warning we have about second quarter is, while we saw improvement in April, we would expect most of the growth to get beyond the low end of the guidance would happen in the second half. Did I answer your question?

speaker
Angela Khomeeri
Analyst, UBS Group

Oh yes, that is helpful. And then my second follow-up is just also a follow-up on type question on workload challenges. What types of practices are making these comments and what are you doing to relieve capacity there? Because our charts have sometimes showed doctors looking at the post-operative adjustment as a barrier to do more LALs. So any color on the practice profile for those making workload challenge comments would be helpful for us.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

So I think that this is not a new observation that we've seen since we've introduced the technology. There have been kind of standard responses as people become first familiar and then start to consider adopting. Typically the initial resistance is around piece of capital equipment and then change in practice pattern that the technology involves. But these are not new. And so we've developed over the last several years not only good explanations for how practices have adopted the technology successfully, but we have many, many examples of that that we can refer new and potential practices to to be able to see the benefits of making that commitment to this technology. And I would say it's not significantly different than every other new paradigm that has come into ophthalmology which these same objections are raised and then overcome.

speaker
Angela Khomeeri
Analyst, UBS Group

Amazing, thanks Ron, Shelley, Oliver.

speaker
Conference Call Operator
Operator

Thank you. Thank you. Seeing no further questions at this time, I will turn the call back over to Ron Kurtz, CEO for Closing Remarks.

speaker
Dr. Ron Kurtz
President & Chief Executive Officer

Well, thank you all for your time and attention today. We appreciate your interest in our excite and we're looking forward to updating you on our progress in future quarters. Goodbye. Thank

speaker
Conference Call Operator
Operator

you. This concludes today's conference call. Thank you all for joining and you may now disconnect.

Disclaimer

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