LNSR - NASDAQ

Good morning and thank you for your participation. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. As a reminder, this conference is being recorded. I would now like to turn the call over to Cameron Radinovic of Burns McClellan. Mr. Radinovic, please go ahead.

Thank you, operator. Good morning and welcome to the LENSAR Fourth Quarter and Full Year 2024 Financial Results Conference Call. Earlier this morning, the company issued a press release providing an overview of its financial results for the quarter and full year ended December 31, 2024. This press release is available on the Investor Relations section of the company's website at www.lensar.com. Joining me on this call today is Nick Curtis, Chief Executive Officer of LENSAR, who will review the company's recent business and operational progress. Following his comments, Tom Staab, Chief Financial Officer of LENSAR, will provide an overview of the company's financial highlights before turning the call back over to the operator to facilitate answering any questions you may have. Today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited and forward-looking financial information as well as the company's future performance and/or achievements. These statements are subject to known and unknown risks and uncertainties which may cause the company's actual results, performance or achievements to be materially different from any future results or performance expressed or implied in this presentation. You should not place undue reliance on these forward-looking statements. For additional information, including a detailed discussion of the company's risk factors, please refer to the company's documents filed with the Securities and Exchange Commission which can be accessed on the website. In addition, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, February 27, 2025. LENSAR undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this live conference call. With that, it's my pleasure to turn the call over to Nick Curtis. Nick?

Thank you Cam and good morning to everyone. Thank you for joining us on our fourth quarter and full year 2024 call [ph]. LENSAR's performance in 2024 can be summarized in one word, outstanding. While there's no such thing as a year completely free of challenges, our team executed exceptionally well and achieved significant milestones throughout 2024, culminating in a record fourth quarter, positioning us for continued growth and market share gains in 2025 and beyond. As always, Tom will provide more granular detail on our financial performance but I will first share with you several operational highlights. We achieved significant revenue growth in 2024. Our fourth quarter top line revenue increased to a record $16.7 million which represents growth of 38% over Q4 2023, with full year revenue growth coming in at an impressive 27% over 2023. The success was fueled by strong performance across all revenue lines, particularly in system placements and procedure volumes. We placed a total of 31 ALLY Systems in the fourth quarter, a new quarterly high for LENSAR. 20 of the 31 systems were installed in the U.S. which is also a single quarter record for the company. We anticipate these new systems reach their full procedure productivity in the second half of 2025 and look forward to the recurring revenue these systems will contribute when they begin generating consistent procedure volume levels which we expect to happen in mid-Q2 for many of these systems. Notably, our expansion in laser placements into Europe and Southeast Asia continued from the third quarter launch with 24 systems total since launching ALLY outside the U.S. after clearance in mid-August 2024. We also continue to build a robust pipeline of executed contracts in the U.S. and consistent demand from our distributors serving customers outside the U.S. We ended the year with a backlog of 16 ALLY Systems which we expect to install and begin generating recurring revenue in 2025. Importantly, we have converted a highly significant number of new-to-LENSAR customers adopting our technology for the first time, making the important decision to either upgrade from older competitive systems or enter the robotic laser cataract surgery market for the first time. In fact, 75% of our new system placements in the U.S. in 2024 were with customers new to LENSAR. This is a clear validation of ALLY's technological advancements and the significant benefits it brings to surgeons and their patients. Further, it's an acknowledgment of LENSAR's ongoing commitment to improving efficiencies, outcomes and overall experience at every level of the practice. This influx of new surgeon partners will further accelerate recurring revenue growth in the coming quarters as they fully integrate and adapt to ALLY which is a great indicator of the underlying health of the important recurring revenue in our business and near-term opportunity. Driven by our strong fourth quarter placement activity, we increased our ALLY placements 86% over 2023. Our installed base of ALLY Systems has now surpassed 135 globally. And our total installed base, including the legacy LLS systems has grown to 385 on a worldwide basis, representing an impressive 26% increase over December 31, 2023. This impressive installed base growth, particularly in the U.S., allowed LENSAR to continue gaining significant market share throughout 2024. According to MarketScope, LENSAR has added an additional 7.5% share in procedures in the U.S. since the launch of ALLY 2 years ago, bringing our total share to almost 21%. This market share growth for us represents a combination of LENSAR growing the overall market and our success in displacing competitive systems from our much larger ophthalmic peers. Procedure volumes increased 24% year-over-year in both the U.S. and worldwide. In addition, 80% of our 2024 systems were installed after June 1, meaning they haven't yet reached full practice integration and utilization and are therefore likely to contribute to recurring revenue at a greater level by providing the $40 million we achieved in 2024. As utilization with these newly installed systems ramps up, we expect to see continued growth in the recurring procedure revenue, particularly from users who have switched to ALLY from the older competing lasers. We're focused on continuing to expand our footprint through strategic placements which will further drive the significant procedure and revenue growth in 2025 and beyond. This continued growth in recurring revenues represents an important metric in assessing the underlying health of our business. As I mentioned previously, procedure volumes directly correlate to our recurring revenue which we believe is a highly effective and important measure of our growth and long-term success. In the fourth quarter, our recurring revenue totaled approximately $10.8 million. And as I mentioned a moment ago, we had over $40 million in recurring revenue for the year. Looking ahead, we're confident in our ability to continue delivering strong financial results and achieving our ambitious growth objectives. One of the drivers of this growth is the increasing number of practices that are moving ALLY out of a dedicated procedure room and directly into the operating room and thus taking full advantage of ALLY's ability to be a part of a fully sterile, single-room laser cataract surgical procedure. We've seen substantial growth in the number of sites that have added multiple ALLY Systems into multiple operating rooms which is also expanding our overall procedure numbers because of the increased productivity and efficiencies. More surgeries in a given timeframe within it drives an increase in procedure revenue and profitability or provide surgeons the ability to finish the day earlier and reduce overhead associated with performing fewer surgeries while also cutting overhead due to inefficiencies in their current business models; this will drive additional growth and multi-trade system sites. We attended several U.S. and OUS congresses, including the AAO in the U.S. and the ESCRS in Barcelona, where we not only performed many ALLY System demos and generated many new leads, especially in the private equity groups and in-office surgical suite markets. We also had the opportunity to participate in the innovation meeting held in Barcelona, preceding the ESCRS in a panel discussion on moving digital data into the OR and the impact on the productivity and outcomes of this technology integrating the patient level data throughout the office. We also partnered with our European distributor for an advanced ALLY user group meeting as well as our Asian partner with their KOLs at the Taiwan National Meeting. I'm also pleased to report we've had a total of 11 abstracts accepted for presentation at the ASCRS Annual Meeting in late April. We'll be providing additional details on the full slate of Podium and Poster presentations in the coming weeks. I hope that we'll see some of you there. Before turning the call over to Tom, I would like to take a moment to acknowledge and say thank you to the entire LENSAR team for delivering such strong performance and helping us reach such critical milestones throughout 2024. We advanced our U.S. business significantly and alongside our distribution partners successfully launched ALLY in the EU and Southeast Asia, where surgeon feedback to date has been incredibly positive. This global expansion, coupled with our continued performance in the U.S., puts us in a strong position with a great deal of momentum as we head deeper into 2025. We're excited about the opportunities that lie ahead. Now let me turn the call over to Tom and he'll cover our financial highlights for the quarter. Tom?

Thank you, Nick. As Nick mentioned, the fourth quarter was an outstanding quarter for us. We finished the year with revenue of $16.7 million in the fourth quarter, representing a remarkable 38% increase over the $12.1 million in the fourth quarter of 2023. This growth was primarily driven by the 31 ALLY placements in the quarter and strong system sales, both domestically and internationally. Fourth quarter placements increased over 100% year-over-year globally and 33% in the United States. We also had strong procedure growth with overall procedures growing 22% on a worldwide basis and 24% in the United States when compared to the fourth quarter of 2023. For the quarter ended December 31, 2024, approximately 64% of our revenue was recurring compared to 73% in the same period of 2023. This shift reflects the increased contribution of ALLY System sales in total revenue which rose to $5.9 million from $3.3 million in the fourth quarter of 2023. Additionally, as Nick said, over 80% of our systems placed in 2024 were installed after June 1, meaning these systems have not yet received -- have not yet achieved full procedure productivity and thus, were not contributing to recurring revenue at their full capacity. Gross margin for the quarter was $7.1 million and represented a gross margin of 42% which was very similar to the 43% realized in the fourth quarter of 2023. Our gross margin for the year was 48%. We expect our gross margin percentage to increase in the future as our sales mix shifts to a greater proportion of procedure-based revenues which carry higher margin than System sales. We generally expect our gross margin to approximate 50% in 2025 with the gross margin percentage highest in the first quarter and lowest in the fourth quarter based on the seasonality of our business. Total operating expenses for the fourth quarter of 2024 were $8.4 million compared to $8.1 million in the fourth quarter of 2023. We continue to invest in our commercial operations to support our growth initiatives and our growing installed base. The increase in sales and marketing expenses was somewhat offset by decreases in other expense areas. GAAP net loss was $18.7 million or $1.61 loss per share in the fourth quarter of 2024 compared to a $3.9 million loss or a $0.35 loss per share in the fourth quarter of 2023. Our net loss for the fourth quarter of 2024 was largely attributed to a $17.6 million noncash charge which is related to the increase in the fair value of our outstanding warrant liabilities. This change in value is directly associated with a 155% increase in our stock price over 2024. As you look at our adjusted EBITDA results, we closed the fourth quarter of 2024 with a positive $478,000 as compared to a negative adjusted EBITDA of $1.2 million in the fourth quarter of 2023. The fourth quarter represents the second consecutive quarter of positive adjusted EBITDA results for us. For context, stock-based compensation expenses were relatively consistent year-over-year at $700,000 and $800,000 for the fourth quarters of 2024 and 2023, respectively. As of December 31, 2024, we had cash and investments of $22.5 million as compared to $24.6 million on December 31, 2023. Importantly, our cash balance increased by $3.9 million during the fourth quarter and $7 million for the last half of the year. Our 2024 performance allowed us to minimize our cash used in the year to $2.1 million. Now, turning to financial guidance. Based upon the strong demand for ALLY and the mid-2024 regulatory clearances in the EU and Southeast Asia, we anticipate top line 2025 revenue growth to be above the 27% growth achieved in 2024. Furthermore, the pattern of revenue throughout 2025 is expected to be impacted by seasonality similar to prior years with our first quarter being the lowest of the year and the fourth quarter being the highest. In regard to further quarter granularity, we expect our first quarter 2025 revenue growth to align with our full year 2024 growth rate of 27%, with additional growth anticipated in the subsequent 3 quarters of 2025. In addition, based upon our disciplined approach to capital allocation and the expected revenue growth from ALLY placements, we expect to achieve positive adjusted EBITDA results for the full year of 2025 with this measure increasing as the year progresses. Finally, to support our expected growth, we will continue to make strategic investments in our commercial organization, including our service and customer applications infrastructure to ensure we continue to serve our expanding customer base with the highest system uptime and the best customer service in the industry. Now, I'd like to turn the call over to Mark to open up the line for your questions.

[Operator Instructions] Our first question will come from Frank with Lake Street Capital Markets.

Congrats on a really strong finish to the year and really strong total year. I was hoping to start with a little bit around kind of mix of placements in the fourth quarter. I heard you call out 20 of those occurred in the U.S. but could you maybe talk a little bit more to femto-naive competitive changeouts versus replacing LLS?

So, thank you for the question. I appreciate it. We -- so as we mentioned, 75% of these placements were new to LENSAR customers. To try to break it down a little, we actually -- as you can see, identical [ph] number of systems, we displaced only a few LLSs, in fact, well below what we thought we were going to be. And in fact, most of these practices that have LLS actually have moved the LLS to another location. So as far as [indiscernible] placing an LLS that just went into no service at all, we're only talking about a couple -- let's say, a handful of machines over the course of the year. In terms of competitive -- what the competitive rates were, about 30% of the systems were replacement of competitive devices. And then there was about 21% and I'm giving you sort of more for the year than the specific quarter, 21% of the systems, just under 22% actually were femto-naive. So we're both growing the market with femto-naive surgeons and sites that are coming on and at the same time, pretty robust replacement of competitive devices. Does that answer your question?

Yes, that was perfect. And maybe just to follow up kind of on that a little bit more. I think you've talked about in the past kind of order of operations, first, take market share; second, replace old LLS systems; and then third, start to go after that femto-naive market. As you've scaled throughout the year and really proven out the benefits of the technology, maybe give an update on kind of that strategy itself and where we lie within that?

Yes. So the strategy -- I'm pleased to say, for now, the strategy is working very well. I think that the company is best served and the surgeon is best served actually, where we go out, given the small sales force that we've got relatively to the much larger companies, spending our time with private equity groups and the larger individual practices that are -- have already accepted laser cataract surgery that are looking to continue providing higher efficiencies and better outcomes and convert more patients. That strategy is good. We don't have to missionary convince someone that they should be doing laser cataract surgery and those sites can become more productive faster. What we are seeing which I'm actually pleased to see that femto-naive [ph] customers, when we designed ALLY, we designed it in mind to really please the practices that have already accepted laser cataract surgery and are looking again to increase those efficiencies, improve the outcomes and we'll recognize that with ALLY. We really felt like we were also addressing the shortcomings that existed in first-generation technology and always believed that as a third segment there, we -- again, with a smaller group, we didn't want to necessarily go out day 1. We wanted to establish a solid base of new-to-LENSAR users and replace competitive devices so that, in essence, through their peer-to-peer and presentations that we would do and abstracts, it would then begin to demonstrate to those surgeons and sites that heretofore either abandon laser cataract surgery or were not doing it. We believe that the system addresses those. And so I'm actually pleased to say that with 21.8% to 22% of customers being femto-naive, they're more or less coming to us at the meetings and the demonstrations and whatnot versus us directly soliciting those at this time. So I'm very pleased with that. And we're going to continue on the path that we are strategy-wise, I think it served us well. Sorry for the long answer.

No, that's great.

And Frank, the only thing that I would add going forward, we're going to continue to target 70% to 85% new customers. But the way we classify that is that they were not a customer in the fiscal year that we're talking about. So obviously, when Nick mentioned in his script that we had systems that were installed and they were adding additional ALLY units in their operating room or to their practice, if they were an existing customer at January 1 in the year, they would -- I mean, if they had an existing ALLY, they would be considered an old customer, not a new customer. So the -- we're still targeting heavily competitive accounts because that contributes to our recurring revenue the strongest. However, it's important to know how we classify existing versus new customers.

Okay, that's helpful. And then just last one for me. Obviously, you're taking a lot of market share. It's a competitive market. There's some other large players in the market. Any changes you're seeing from how they're operating, any investments they're making into their technology or any real change on the competitive front?

It's always a challenge for a smaller, single product company like ours. I would just say that there's strong competition. And -- but we don't see that we're threatened from a technology perspective at all and don't see anything immediate on the horizon there to threaten -- the much larger competitors have the other products and it's a strong, let's say, tug of war between bundling and price versus increasing productivity and improving outcomes and being able to do more in less time. So that's sort of the decision process that the practices have to go to. And really, again, not so much if but when they decide to move out of that bundle and move towards our laser technology-wise.

And our next question comes from Ryan

This is Izzy [ph] on for Ryan. I apologize for any background noise. I just want to echo the congratulations on the progress that you guys made in fourth quarter and in 2024 as a whole. So just to start, I appreciate that you are now providing some guidance for 2025 but I have a couple of questions there. So first, as you think about the composition of sales for next year in the context of growing recurring revenue base, how are you thinking about the split between the mix of sales and leases versus procedural or consumable revenue?

Well, I'm going to let Tom answer part of this but what I'm going to say is that what I see is that, particularly as we get into the larger groups, I see that there'll be more aggressive placements of systems. And so the percentage of sold systems to systems [ph] will drop slightly as the placement demand goes up higher. And so we'll place a higher percentage of systems than we will sell systems overall. And so that mix will change slightly where we were more weighted on the sales side and less on the placement. And as we get more sites and as we continue to grow share, that starts to shift a bit. Tom, I don't know if you want to put any other color in that or...

Yes. Thanks for the question, Izzy. So like we said before, with the EU and Taiwan clearances and the fact that we're a distributor sales model outside the United States, with those additional sales coming in, we'll be more aggressive in the United States on our placements but we'll still keep the sales/lease mix on an aggregate basis about the same and it was about 60% for the year. And so between 50% and 60% placements in the aggregate is about what you should target.

Okay, that's helpful. And as we think about the OUS sales, do you have any expectations on when we might start to see an inflection there given the timing of the product approvals?

Well, we're looking to get some approvals in additional countries. From an inflection perspective, because overall, outside U.S., utilization of these systems because the -- let's say, the premium market segments are smaller in most of the countries. And so there was a significant amount of demand in the beginning here. And just like in the U.S., where we started to ramp up slow and then from there, begin to grow into more new-to-LENSAR customers, I think you're going to see the same -- I don't think you're going to see the same rate outside U.S. quarter-to-quarter as we did in the last, given the demand that was there but this will begin to grow over the course of the year as we move from, let's say, existing LENSAR KOLs outside new [ph] to LENSAR customers. And so there is a substantive number of systems outside of the U.S., 300 systems or so in the EU. LENSAR has a big presence in Germany. We're starting to see some expansion there and whatnot. So I would say it's just going to be one of those steady sort of growth into 2025. And actually, I would see much larger growth coming in 2026.

And just curious, as you guys continue to expand into further or additional OUS markets, do you have any thoughts around you would like to establish a direct presence or continue with the distributor model?

So that's a really great question. I think that it should always be a topic of discussion to think about if and when you might look at certain markets from a direct perspective. I'd say that certainly in the EU and in Asia, we're very comfortable with our distributor, our relationships there and their commitment to the product. I would say it's certainly a topic of discussion in other areas as to if and when we might go direct. And so yes, I think as we continue to grow, we'll see that in some of these other markets, when we assess the opportunity, we may consider a direct presence.

And Izzy, I just wanted to correct my previous statement. I think I said we expected 60% placements. It's actually 60% sales. If I said placements, I meant sales. So I just want to correct that.

And then, Tom, last one for me. Just we noticed that there was a bit of a fluctuation -- or there's been some fluctuations in SG&A from quarter-to-quarter. So I was curious if the $7 million that we saw for fourth quarter is the right baseline for 2025? Or do you expect this to ramp up as you continue to invest in growing the business?

Yes. So it's a little bit of a misnomer. Like we've said before, on cash-based commercial expenses, they were increasing at 16% but we actually decreased our administrative expenses. So I think that we're going to continue to invest in the commercial infrastructure and we're going to do that gradually and as probably a little more aggressively than what we've had in the past but not much so. I don't think that we'll be able to squeeze as many administrative expenses or any additional administrative expenses out of the business. And so you'll see the SG&A line tick up just because there isn't that offset that we've seen before.

Congratulations again on the progress in 2024.

Thanks, Izzy [ph]. Appreciate it.

This now concludes our question-and-answer session. I would like to turn it back over to Nick Curtis for closing remarks. Go ahead, Nick.

Thank you, everyone, for your participation in today's call. We certainly appreciate it. We're pleased to have shared our strong 2024 results with you. We're really excited about the opportunities that lie ahead. LENSAR is committed to revolutionizing the field of laser cataract surgery through innovative technology and, of course, a real dedication to excellence. We believe that ALLY has the potential to really transform the surgical experience for both the surgeons and patients and thus the name ALLY and we're committed to making that vision a reality. And we certainly look forward to continuing this journey with you and we'll continue to provide further updates on our progress. Thanks for joining.