LENSAR, Inc. (LNSR) Earnings Call Transcript & Summary

Good morning, and thank you for your participation. [Operator Instructions] As a reminder, this conference call will be 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 First Quarter 2022 Financial Results Conference Call. Earlier this morning, the company issued a press release providing an overview of its financial results for the quarter ended March 31, 2022. This press release is available on the Investor Relations section of the company's website at www.lensar.com. Joining me on the 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 Nick for closing remarks. 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, May 9, 2022. 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. It is my pleasure to turn the call over to Chief Executive Officer, Nick Curtis. Mike?

Thank you, Cameron, and good morning to everyone listening. Thank you for joining us on our first quarter 2022 conference call. We have achieved an impressive start to 2022 by returning to our historical growth trends as well as delivering on our previously promised critical strategic milestone with the submission and the FDA subsequent acceptance for substantive review, our 510(k) filing for ALLY. Our first quarter revenue in worldwide procedure volumes each increased more than 30% compared to the first quarter of 2021. In addition to steady growth in procedure volumes, we have continued to see increases in both system sales and lease placements for our current generation LENSAR Laser System with streamlined and IntelliAxis Refractive Capsulorhexis by increasing systems placed on a worldwide basis to approximately 255 systems. This represents a 30 system increase from March 31, 2021. These additional system placements and the associated year-over-year procedure increase represent a strong foundation upon which to launch ALLY and continued validation of the core feature technology advantages of the current LENSAR system in comparison to other femtosecond lasers available in the marketplace. Furthermore, we intend to continue leading innovation by giving refractive cataract surgeons, even greater technology performance and procedure efficiencies with ALLY, thereby enabling them to provide highly optimized patient outcomes and provide an overall better patient experience in their cataract surgery procedures. These advancements and commitment to the continuous improvement of our device are at the heart of the reason why U.S.-based LENSAR Laser Systems performed twice as many procedures as the industry average. We've also made tremendous headway in broadening surgeon awareness of ALLY. Most recently is measured and recognized at the ASCRS a few weeks ago. I would like to highlight some metrics from the ASCRS meeting is it's arguably 1 of the largest and most relevant U.S. congresses in our field. Attendance was significantly higher than last year with nearly 3,000 surgeons attending in person. Furthermore, LENSAR was well represented with 8 podium presentations demonstrating improved patient outcomes and the management of stigmatism with reproducibility and precision that is not seen with manual and other laser technologies. This provides LENSAR surgeons the opportunity to broaden use of their lasers to treat more patients because they have the confidence that they can deliver on their patients' expectations and these advanced cataract surgical procedures. We also have the opportunity to invite attendees to a LENSAR experts meeting, which consisted of 3 comprehensive sessions covering the deep dive in the user experiences with our current LLS, new clinical data and review of the first human cases performed with ALLY. For the first time, we opened attendance to include a small group of non-LENSAR KOLs interested in the adoption of LENSAR with ALLY. We're thankful to the surgeons that presented their results and shared their experiences as well as to all the attendees. The turnout for these interactive sessions was very encouraging and expanded awareness of LENSAR systems' capabilities and the ability of our system to play a key role in facilitating better patient care. Over 140 ALLY demonstrations in total were completed. Over 120 surgeon demonstrations were performed with 55% of these demos conducted for non-LENSAR customers. Market Scope recognized the LENSAR booth is one of the busiest at the ASCRS. That's gratifying recognition of our commitment to delivering cutting-edge technology and the enthusiasm surrounding ALLY. We also achieved a major milestone in the company's history with the submission and subsequent FDA acceptance of our 510(k) application for regulatory clearance of the ALLY in February. Our application is undergoing substantive review by the FDA and is cleared, we're on track to launch ALLY in the second half of 2022. We look forward to continued and productive interactions with the FDA and with our filing. Now more than ever, we believe that ALLY represents the next great innovation refractive cataract surgery. It appears as though is shared by a number of surgeons that were excited to demo ALLY for the first time. ALLY has the potential to be the first platform in the market to combine a next-generation dual pulse femtosecond laser with a world-leading Swiss-made phacoemulsification technology in a fully integrated system, allowing surgeons to prep the patient wants to perform a sterile flax and cataract procedure. The significantly faster scanning and laser treatment time and not having to move and re-prep the patient demonstrated that our patient treatment experience to date indicated a time savings of 10 minutes per case. ALLY is a transformative system that integrates current LLS core features, including cataract density imaging, customized fragmentation and energy settings, optimized incisions with proprietary astigmatic guidance technology to adapt to every patient condition, surgeon treatment preference and the work environment. I look forward to the remainder of 2022 at LENSAR as we have been able to build off the momentum generated in 2021 and the excitement surrounding ALLY, and the ASCRS is confirmation of our belief that we're on the verge of revolutionizing the cataract surgery market. We look at this excitement as a strong indicator that our commitment to delivering substantive and meaningful advancements is beginning to pay off. We look forward to updating you on our ALLY filing in the coming quarters. And now I'm going to turn the call over to Tom to cover our financial highlights for the quarter. Tom?

Thank you, Nick. Our first quarter 2022 financial results are included in our press release issued earlier this morning, but I'd like to take this opportunity to expand on that information by adding some color to those remarks. Revenue was $9.3 million in the first quarter of 2022 compared to $7 million in the first quarter of 2021. All individual components of revenue, product, lease and service increased from the first quarter of 2021. It was a very strong quarter for us with total revenue increasing 33% over the first quarter of 2021. The increase in 2022 total revenue was primarily driven by increased procedure volume. In the first quarter of 2022, there were 38,901 procedures sold compared to 28,122 procedures sold in the first quarter of 2021. Our procedure volume increased 38% over the first quarter of 2021. Gross margin for the quarter was $4.7 million or a 50% gross margin percentage and represents an approximate $800,000 increase compared to the $3.9 million realized in the first quarter of 2021. By all measures, the first quarter of 2022 was a strong quarter for us with a 33% increase in revenue and a 38% increase in procedures, both representing impressive performance. Congratulations to our team for such an outstanding quarter. Looking to the rest of the year, 2022 represents a transition year for us, and we expect our gross margin percentage for the year to approximate 50%, with the latter part of the year having a higher gross margin percentage than the first half of the year. The transition of our manufacturing from our first-generation system to ALLY and supply chain challenges, which include difficulty in obtaining inventory and a higher cost of raw materials lead us to expect a lower gross margin percentage in 2022 than percentages achieved previously. We expect annual gross margins to begin to improve in 2023 and continue to improve in future years as we are able to realize manufacturing and purchasing economies of scale and absorb overhead more efficiently. In addition and relatively unique to this quarter, our Q1 2022 gross margin was negatively impacted by higher service costs. Approximately $600,000 was incurred to replace expensive parts in several installed systems. The replacement of these expensive parts and the magnitude that occurred in the first quarter is considered unusual. Total operating expense for the first quarter of 2022 were $11.4 million compared to $9.1 million in the first quarter of 2021. The increase in operating expenses was largely due to an increase in R&D activities as we filed our 510(k) for ALLY and purchased inventory components and built ALLY prototypes for which these costs were expensed to R&D and will be until we receive FDA clearance on our 510(k). Also included in operating expenses were noncash stock-based compensation expenses of $1.6 million and $2.3 million in the first quarter of 2022 and 2021, respectively. The increase in R&D expense for the first quarter of 2022 was related to additional costs for the continued development of ALLY as well as materials purchased for the manufacture of ALLY, which amounted to approximately $2 million. Accordingly, our R&D expenses were somewhat inflated in the first quarter due to these inventory purchases. We expect this situation to continue in the second quarter of 2022 and up until we obtain clearance on our 510(k) filing. Net loss for the quarter was [ $6.7 million ] or $0.67 loss per share compared to $5.2 million or a $0.56 loss per share in the first quarter of 2021. Adjusted EBITDA for the first quarter of 2022, which excludes the effects of stock-based compensation expense mentioned earlier, was a $4.2 million loss compared to a $2.2 million loss in the first quarter of 2021. As a reminder, we use adjusted EBITDA to evaluate our cash flow and profit from operations. When you consider or deduct R&D expense, we have a positive cash flow and profit from our operations. As of March 31, 2022, we had cash and cash equivalents of $29 million as compared to $31.6 million at December 31, 2021. Cash utilized in the quarter was $2.6 million. With $29 million in cash at March 31, a cash burn of less than $10 million for fiscal 2021 and our ALLY 510(k) accepted for review by the FDA, we have a strong balance sheet in which to launch ALLY and have positive momentum going into the second quarter. Now I'd like to turn the call back over to our operator, Jerome, and we look forward to your questions.

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

I just want to start with talking about the installed base and utilization a little bit, and it continues to grow really nicely and the procedure volumes are very encouraging to see. And I'm just curious, Nick, if you can kind of talk about -- I mean, some of your users have been with the system for a while, kind of how their utilization looks on their system relative newer users and kind of what it takes for those newer users to ramp up, I think it would be helpful to understand. And if you could also just comment on kind of -- I mean, the procedure volumes, again, very encouraging. How is that trending into April and early May?

Yes. Thanks, Ryan. Those are really good questions. So we kind of look at things like once a customer has had a system for -- let's just call it, 6 months because there's a ramp-up period. And the ramp-up period usually consists of getting into a new account getting the staff trained, support staff is very important, getting the clinical operators trained, getting people comfortable with the system, getting the doctors trained to the point where they understand the features and the differences primarily between the LENSAR system and the system that they may have been using prior to LENSAR in. And so this sort of ramp-up period, which is in that first 90-day period where we look at going from very little revenue to where we're generating good procedure volumes. After that 90 days, they start to get to the procedure volumes that they were at prior to putting LENSAR in there. And then by the time we're in that those 4 to 6 months, 4 to 6 months out, we're usually operating very efficiently within the practice and beginning to see procedure growth. The -- as we continue to evolve the system by adding preoperative surgical devices and adding other efficiencies and whatnot, we see the existing accounts as they continue to be more comfortable, they grow within that as well. They either grow organically through the 3% growth rate annually that comes just from cataract surgery in general. And then what's been happening is that conversion rates to these types of procedures and particularly in the area of management of the stigmatism continues to grow within the practice as they continue to optimize their nomograms and whatnot. Given any real shutdown to your second question, any real slowdown as a result of any COVID variances or something unusual that we can't predict. We see that procedure volumes will continue to be strong, particularly as there -- it appears that there still is a backlog from COVID in just available surgical time for doctors to be able to do their cases. So we would expect that, at least from a surgical procedure perspective that we would continue to be strong there.

And very encouraging...

Ryan. One other thing to add to Nick's comments is the -- outside the United States procedure volume was really, really strong in the first quarter. As you go into May or April and early May, outside the United States has backed off a little bit, but the U.S. has picked up a little bit and the U.S. is 50% of our volume. All in all, you're seeing a slight downtick from the first quarter, but it's still a very robust procedure volume, and you'll see procedures increase from the second quarter or we would expect you would see that they would increase from the second quarter of '21.

And your next question comes from the line of Danielle Antalffy with SVB.

Congrats on a really strong quarter and a strong showing at ASCRS. Nick, I was wondering, as you think about ALLY, thank you guys so much for the data on a number of demos and particularly new or noncurrent users. So as we think about that and think about the upcoming FDA approval of ALLY, how do we think about the rollout there? I spent some time at the booth, if I can see that the anticipation is high. So I'm guessing a lot of these doctors are just asking when can we get 1? So help us understand how you guys are approaching the rollout of ALLY once it's approved?

Danielle, thanks for getting on the call today, and thank you for coming by at ASCRS and seeing the system as well. So we obviously are excited, and we know that surgeons are very enthused to want to see ALLY in their practices sooner rather than later. That said, it would be imprudent on our part, particularly with a brand-new piece of technology that's moved from an R&D into full ball manufacturing that we're -- that we are cautious and that we control our launch. And so we're planning on what we refer to as 10 friends and family sites when we begin the rollout with ALLY shortly after the clearance. And that will consist of, of course, some existing LENSAR users and a few of new KOL users that we've been working with along with our current user KOLs in sort of this whole process to begin with as we move forward. And so we're looking at putting those 10 sites in place and then following those sites for a few months in order to be comfortable that everything is performing exactly how we expected, that we understand what we're doing from a training perspective that the surgeons are adapting to it that we're getting what we advertise, so to speak. And then we'll expand into an additional phase, which from there looks to be another somewhere between 10 and 20 systems. And so before we get into sort of full launch mode in 2023.

Got it. Okay. So that was my next question. So right to think about this 2022 will be more measured, 23, you can let the [indiscernible] year.

Yes, assuming that we don't have continued issues as it relates to supply chain, of course, but yes.

Okay. Okay. And then when thinking about utilization, just following up on Ryan's question there, utilization on the current system versus how we should think about utilization on ALLY. And I know it hasn't launched yet. So I guess TBD, but theoretically, you have to think that utilization could move significantly higher with ALLY given the improved efficiencies on the system. So just how are you guys thinking about even theoretically or qualitatively would be helpful.

Those are great questions and obviously, things that we're very keen on wanting to get the answer as quickly as possible as well. So we're working in a couple of different situations here because you may recall that in the past, I've said that most of these systems today, no matter what company they're from sit outside of the operating room. And that with ALLY, you have the opportunity to move into the operating room, if you want to take advantage of full efficiency of the system to perform a sterile procedure to be able to switch even if you weren't using the LENSAR Phaco system and you're using whatever Phaco system you're using today to switch from the femto to the phaco in a sterile environment. Certainly, from a flow perspective, becomes much more efficient and faster. And so we see this happening and part of what we're going to be doing in these 10 accounts is that you'll likely have a few accounts that will continue to put the laser where they have the laser today in order to just really become comfortable with the system and the fact that it is that much faster and inefficient. And then you'll have a few of these accounts that will put them right into the operating room. And we have a private equity group, one of the private equity groups that we're working with actually wants to study and do some flow analysis with us because they're interested in ALLY on a much broader basis for more of their practices and all ours, if you will. So -- so we'll have an experiment where we put 1 in each of 2 operating rooms. And we'll see how much faster and more efficient and better use of the human resource as well in terms of transporting patients and whatnot that we do. I alluded to the fact that in our first clinical patients that we had done the doctor was reporting that we were saving in the treatment time about 2 minutes and in the transport time and prepping of the patient another 8 minutes or about 10 minutes with each patient in their cataract journey there. And so really, the next months are going to be in those 3 scenarios really testing those things out. Did that answer your question?

Sure did. Thank you Nick. That was helpful.

I'll hand the call back to Nick Curtis.

Thank you, everybody, for joining our call today. As you can tell, we're quite enthusiastic about what's going on here at LENSAR. We certainly appreciate the fact that you're interested as well, and we look forward to continuing to update you as we make further progress.

All right. Thank you. And that concludes today's conference. Thank you all for joining. You may now disconnect.