Greetings. Welcome to the STAAR Surgical First Quarter 2024 Earnings Call and Webcast. [Operator Instructions] Please note this call is being recorded today, Tuesday, May 7, 2024. I would now like to turn the call over to Brian Moore, Vice President of Investor Relations of STAAR Surgical. Please go ahead.

Thank you, operator. Good afternoon, everyone, and thank you for joining us to discuss the company's financial results for the first quarter ended March 29, 2024. On the call today are Tom Frinzi, President and Chief Executive Officer; and Patrick Williams, Chief Financial Officer. The press release of our first quarter results was issued just after 4:00 p.m. Eastern Time. We have posted the earnings release and our earnings presentation supplement to the Investor Relations section of STAAR's website at www.staar.com. Before we begin, let me quickly remind you that the company comments during this call will include forward-looking statements. We caution you that any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the company's projections, expectations, plans, beliefs and prospects. These statements are based on judgment and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. The risks and uncertainties associated with these forward-looking statements are described in the safe harbor statement in today's press release as well as STAAR's public periodic filings with the SEC. Except as required by law, STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so. In addition, on this call and in the press release, we discuss certain non-GAAP financial measures, including adjusted EBITDA and adjusted EBITDA per share. We also provide sales data in constant currency. Definitions and reconciliations to GAAP are included in today's press release. For brevity, unless otherwise specified, all comparisons on today's call will be on a year-over-year basis versus the relevant period. Following our prepared remarks, we will open the call to questions from publishing analysts. [Operator Instructions] Finally, we intend to use our website as a means of disclosing material, nonpublic information and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the Investor Relations section. Accordingly, investors should monitor our investor website in addition to following our press releases, SEC filings, and public conference calls and webcast. And with that, I would now like to turn the call over to Tom Frinzi. Tom?

Thank you, Brian, and good afternoon, everyone. I'm pleased to report STAAR generated net sales of $77.4 million for the first quarter of 2024, which exceeded our outlook. Our enhanced commercial focus is yielding positive results. And our proprietary EVO ICL lens-based technology, again delivered above-market rates of growth across all key geographies. We exceeded our original expectations for the quarter, even in a down market for the predominant procedure in our industry, laser vision correction. EVO is taking market share, building the channel for refractive vision correction and our momentum is growing. We are proud to report multiple business and execution milestones in the first few months of 2024. Including today's announcement of the largest commitment ever to EVO ICL in the U.S., a strategic agreement with Dr. Robert Lin and IQ Laser Vision as part of our U.S. Highway 93 go-to-market program. Thus far in 2024, we generated 21% sequential sales growth in the U.S., achieving record quarterly U.S. ICL sales of $5 million. We believe this represents a new base level of quarterly sales in the United States. Our agreement with Dr. Lin is the largest ever commitment to EVO ICL in the U.S. to date and follows on the agreement we announced with sharp vision also in the first quarter. We have qualified a dozen U.S. Highway 93 EVO ready customers to move into the fast lane, if you will, and signed agreements with half since the program launched in the fourth quarter of 2023. These fast lane customers believe in the merits of EVO ICL and are increasingly recommending the EVO procedure to their patients. They are committed to growing EVO as a percentage of the refractive procedure mix, initially targeting 15% to 30%. Dr. Lin has implanted over 1,000 ICLs in the prior 12…

Thank you, Tom, and good afternoon, everyone. Our Q1 2024 results were slightly better than what we reported in our April preliminary announcement in the key areas of net sales, profitability and cash. Total net sales for Q1 2024 were $77.4 million as compared to net sales of $73.5 million in the prior year quarter. As a reminder, Q1 and Q4 have historically represented our seasonally lowest quarters. The $3.8 million increase in Q1 2024 net sales is attributable to a 9% or $6.5 million increase in ICL sales, partially offset by a decrease in cataract IOL, which the company wholly exited in fiscal 2023. Changes in constant currency negatively impacted total net sales by approximately $1 million or approximately 130 basis points in the first quarter of 2024. During the quarter, we successfully added a second distributor for our China operations. We are very pleased with how smoothly this has gone and the new agreements in place have resulted in higher net ASP realized across our total business in China. For Q1 2024, gross profit was $61 million or 78.9% of net sales as compared to gross profit of $57.6 million or 78.3% of net sales for the prior year quarter and $60.7 million or 79.6% of net sales for Q4 2023. The year-over-year increase in gross margins is primarily due to country and product mix. The sequential decline in gross margin is primarily due to inventory adjustments. For 2024, we continue to expect gross margin will be approximately 80% of net sales for each quarter and the full year. Moving down the income statement. Total operating expenses for Q1 2024 were $63.3 million as compared to $54.8 million in the prior year quarter and $50.3 million in Q4 2023. The increase in operating expenses reflects our decision to…

[Operator Instructions] Today's first question comes from Margaret Kaczor with William Blair.

The first question for me is really around the U.S. I mean you guys had a great quarter, really nice to meet your expectations, our expectations, great sequential worth I think you were expecting 10% for the full year. It sounds like you're still expecting that. So the issue is if I keep the U.S. flat at $5 million a quarter for the rest of the year, it gets you above that range. So I guess what's implied for the cadence for the U.S. throughout the remainder of the year? Do you still expect that $2 million step-up that you used to talk about in the second half or not? And any kind of details kind of on these new Highway 93 partners like SharpeVision now IQ Vision metrics in those folks that entered the program.

Thanks for the question. And look at where -- as we said in the pre announcement, we reiterated here today, we were very pleased with the U.S. results coming out of Q1, certainly ahead of what we certainly signaled as we started 2024. And I think when you build the new categories, lens-based refractive surgery, it takes time. And the investments we've made and the strategies we put in place during the course of 2023 are beginning to bear fruit, resulting in agreements we signed with people like SharpeVision and IQ Laser. And I think, look, one quarter does not make a year. We're trying to be prudent. I think we're confident that we've established a new baseline of business as we mentioned here at around $5 million per quarter. Do I think we have upside opportunity in the back half of this year as we signaled originally. I do, but we're trying to just be cautiously optimistic given some of the macroeconomic headwinds that are out in the marketplace. So I think Q2, we'll see how that plays out. But clearly, with laser vision correction being down 19% in Q1 and EVO being up 15% year-over-year, I think, speaks volumes to the market is beginning to really embrace and engage lens-based refractive surgery.

Okay. That's helpful. So we'll hopefully look for some metrics maybe around the Highway 93 partners as we go on throughout the year, it sounds like -- and you had referenced macro a little bit in that answer, Tom. So can you give us any update or flavor as to what you're anticipating if there's any change at all within guidance on the macro environment, stable, improving, getting worse, especially as we think about markets like China. Great to hear ASPs are increasing some, but maybe you can true us up a little bit on how you guys are thinking about that going into Q2 and the rest of the year.

Yes. Obviously, none of us are economists. We read as I've mentioned previously, the same headlines we all see in the papers. And I think in particular in China, it's continuing to be a choppy economic environment. We saw a nice growth in January and February. We saw a little bit of a slowdown in March in China, in particular, we saw it continue into early April, but the back half of April and 1 week or so into May, we're encouraged by some uptick in the China market. And again, we thought the market would be relatively flat. We're pleased that we came in with 10% growth. We signaled earlier in the year that we thought the back half of the year in China, we would see some nice uptick there and we continue to believe that. So again, we're trying to be prudent. We're trying to be cautiously optimistic. Our China business is in good shape, as many of our other markets are as well because we saw growth in Q1 across all of our major geographies.

Our next question comes from Tom Stephan with Stifel.

Maybe I'll start with the U.S. in 1Q, again, nice to see the early momentum. I guess, qualitatively, Tom, can you elaborate a bit on sort of what you believe specifically is going well as you continue to refine your U.S. EVO strategy, are there any noticeable areas of improvement you're finding in play, whether that's in your execution, maybe with doctors or with patients?

Yes. I think, Tom, first of all, thanks for the question. I think it is across the board. As I said, we concentrated on surgeon confidence around measurement and lens size selection. And the papers that we published in the first quarter, I think people added support and data and confidence that you could perform this procedure safe and effective. I also think in the U.S., look at whether you want to call it fear of missing out or herd mentality as we're building momentum as we're signing new agreements, in addition to the 2 we have mentioned, we signed 4 additional agreements since the end of 2023 that are just demonstrating that lens-based refractive surgery in the face of declining laser vision correction is becoming more and more meaningful in the practices. So yes, our execution is better. We're surrounding the customer in a more effective way. We have new tools to bring to bear at the practice level. And all of that is giving us real confidence that we're beginning to crack that code, if you will, and I think it's been reflected in our numbers.

That's great color. And then my follow-up question is just on guidance. You beat 1Q by, I think, over $5 million. But for now, only have raised by basically $2 million to $3 million. I know there's conservatism and you want to be prudent. But can you talk about key reasons why maybe you didn't flush through all or at least more of the 1Q upside just as we kind of look ahead at the rest of '24. And then Patrick, a quick follow-up for you. Any additional color on cadence of revenue for the rest of the year? Sorry if I missed that.

Sure. I think in terms of the first part of your question, I think it is just prudent. Let's see how Q2 comes in. And I think we'll react accordingly. Q4 was a strong quarter for us in '23. Q1, following up. And I think let's see how Q2 comes in. And then as we either preannounce or talk in August at our next earnings call, stay tuned.

And we had said approximately $95 million for Q2 based on our current trends that we're seeing up there.

And our next question today comes from Patrick Wood at Morgan Stanley.

Amazing. I'll keep it to 2. I guess, given the progress you're seeing in the U.S., and I know it's early days in the turnaround, but big picture, longer term, can you think of any structural reason that the U.S. couldn't get to the high teens to low 20s, ICL penetration rates that we're seeing quite a lot of EMEA.

Yes. Patrick, I think it's a fair question, but whether it's 10%, 15%, 20%, 30%, I think we just have to keep our head down, keep doing the things we're doing that we know are moving the needle, increasing surgeon confidence, providing the kind of clinical and marketing support. As we said, we thought it was appropriate to kind of adjust our spend away, if you will, from brand awareness to more downstream marketing and really surrounding the customer clinically and commercially. And we've been doing that. We'll continue to do that. And I think as we execute, as we did in Q1, I think the numbers will bear out what it's going to bear out, but we remain confident that lens-based refractive surgery is becoming more meaningful in each of the practices they are embracing EVO.

Totally get that. And then I guess it's not up for you guys in a way to sort of speculate to some degree. But why do you think the refractive market in the U.S. is so weak at the moment? Is that a read on the consumer or we get mixed signals there? I appreciate you're taking a lot of share out of that slowly, but why do you think the market overall is having a difficult time?

Yes. I think historically, in Vision correction, there's been a fear factor and there's been a cost factor. And obviously, with the choppiness in the economy, I think people are playing it a little closer to the vest in terms of discretionary spending. But again, we're encouraged because in the face of that reality, we're continuing to outpace the market. So clearly, we're overcoming the fear factor and people are seeing value in what EVO is delivering in terms of postoperative outcomes. So it gives us certainly confidence that we'll continue to [indiscernible].

And our next question today comes from Young Li with Jefferies.

All right. Maybe starting with the U.S. It seems like the 1Q beat was fairly broad-based. I wanted to hear a little bit about how Highway 93 accounts performed versus non Highway 93 accounts? And maybe thoughts on you guys adding more practices into Highway 93 or maybe training or retraining some practices in '24 and '25.

I've said on several occasions, I didn't think we needed to go wider. We just needed to go deeper. Look, we're never going to walk away from the demand that's out there. We're continuing to take on new customers, but our uber focus on the Highway 93 initiative is bearing fruit. So we're continuing to focus on those practices that are set up for success, whether that's a setting of care, whether that's a committed surgeon and staff, whether it's clinical coordinators that are really confident in speaking to the benefits of our EVO technology, et cetera, et cetera. So I think right now, we feel very confident that there's probably a 10% to 20% base of those 93 accounts that are really embracing the technology. And again, this idea of herd mentality, fear of missing out as they continue to be on the podium, a great example, ASCRS in Boston, we went from a year ago, 20 or 25 presentations to 40 to 45 presentations. So we're part of the flow of commerce now and that gives us avid confidence of where this technology is going to go in the U.S.

I think directionally, we're not going to give specifics, but we did see the Highway 93 perform better on a year-over-year basis than the -- what we'll call the other 400 accounts. But I think that speaks volumes to what Tom said a couple of times now, which is clearly, there's a bit of fear of missing out, herd effect whatever we want to call it, and we're seeing the benefits of that. And -- but not only the U.S., but as we move forward and the rollout of STAAR University, the increased focus on surgeon confidence. You're going to hear us talk a lot more about that as we know throughout this year, not just for the U.S., but how we're going to roll that out across the globe because it's imperative that we continue to move down the diopter curve and really begin owning minus 6 and above.

All right. Great. That's very helpful. I guess to follow up on China. For the results in the first quarter, it seems like you started the quarter pretty strong. Maybe towards the end, there was a little bit of pressure. I heard the $95 million guidance for the second quarter. It seems like there's some conservatism built in it, starting off the year. But I wanted to hear a little bit more about the China performance intra-quarter, especially towards the end of first quarter. And any early comments on the second quarter so far as you enter the toughest comp of the year.

Yes. Young, as I previously mentioned, I think we saw a good, strong January, February, a little softer in March that continued through the first part of April at the back half of April and early into May, we're encouraged by what we're seeing.

Yes. I think overall, you mentioned the $95 million that we just talked about for this year in Q2. I think we need to remember, this time last year, it was a tough comp. The first half of last year was very strong. APAC, China specifically was very strong as we came out of the COVID restrictions going into Q2 especially a lot of enthusiasm was out there. And then we, of course, saw that in the back half of 2023, the second half, the procedures just weren't as robust. So I think we feel good about the $95 million. Our goal this entire year is to put numbers out there that we feel good about that we feel confident about. We obviously overperformed in Q1, and we'll see what happens in the next 90 days as we report Q2. But wanted to make sure that people do remember a little bit of history, and we are coming up a pretty hard comp related to Q2.

And our next question comes from John Young at Canaccord.

Tom, Patrick. Congrats on the quarter. I also kind of want to circle back to China here, too, if we can. I know you guys traveled there recently or at least talked about Q4 call. So I would love to get your perspective of what you saw on the ground there that supported the growth outlook that you're talking about today. And specifically, any update on either the local lens competition that may be coming in the second half of this year or any impact from VBP that we should be thinking about?

Yes. No, no problem, John. Thanks for the question. I was there in February or March of this year. On the back end of our expert user meeting that was in Japan. And again, I continue to be impressed every time and I've spent 3 trips there in the last 15 months that restaurants are crowded, malls are crowded. People are out spending money. And again, in our largest account in that region, they had a very good Q1 year-over-year. And again, as Patrick said, that's against a pretty strong comp. So I continue to feel good every time on the year in terms of the consumer reaction, clinics are busy, et cetera, et cetera. So my confidence remains high. China is a big part of our revenue today. It will continue to be a big part of our revenue, and we continue to invest appropriately. We hope to probably exit this year going from about 80 employees on the ground to over 100, again, demonstrating our commitment to that market, and that market's commitment back to us.

Yes. Maybe to add, part of it is adding the second distributor that we talked about in my prepared comments, but trying to become more efficient, being able to deliver products more timely, especially in this Tier 3 and Tier 4 cities, and that was a big reason why we did bring on the second distributor, which had a much larger infrastructure within China. So that perhaps gives us an opportunity to get some more people out there.

Great. And then just circle back. Have you guys seen any updates on the local competition from the [indiscernible] lens? Or are you thinking about any VBP impact?

Yes. No, I think what we continue to hear that they could come to the market sometime in the second half of this year or early into next year. But again, as we have said in the past, John, you've heard it from us a couple of times, I think competition is a good thing that they're coming. It validates the market opportunity, all boats rise, if you will. But again, a couple of things about that product in particular, it's an acrylic material. That material has certainly come to the market in the past and not been successful. It will only be spherical and not toric. And about 50% of our revenue comes from the toric side. So we think that's going to hamper that rollout. But we're certainly cognizant of, respectful of competition coming, but I think we have strategies in place and a strong team on the ground to be able to continue our momentum even in the face of competition coming.

And our next question today comes from Anthony Petrone at Mizuho Group.

I'll have one on China and one on the U.S. On China, Tom, curious just your thoughts more on the stimulus program announced in March, and we have a couple of companies focused in China in different areas of med tech. And there is a thought that in the second half, we can see some momentum from stimulus specifically. So any thoughts on how stimulus plays out for ICL in China into the second half? And then I'll have one quick follow-up on U.S.

Sure. Yes, Anthony, obviously, customers seem encouraged by the stimulus. As we signaled, we thought originally, we would see a relatively flat first half of the year in China with growth in the second half. We've obviously seen the growth in Q1. So I think stimulus is being well received, and our customers has certainly signaled to us that the second half of the year, they should feel the impact of it.

That's helpful. And a quick follow-up on U.S. at the ASCRS meeting had some studies on just bulk measurements and how that plays out for -- in the surgeon training, but also just implementation real world. So just wondering your latest thoughts on bulk measurements in the U.S. what is the timing for potentially seeing a software program that can streamline that process? And do you still view that as a barrier here in the U.S. adoption curve?

Well, I think as those papers indicate, we had 3 actually come out while we were in Boston, one in particular dealt with the difference between all the various biometers that are out in the marketplace and in a sense created a surgeon or fudge factor that certainly could help surgeons as they make those measurement and lens size selections. We do believe that's part and parcel of the confidence factor that's out there. We are working with several independent investigator trials around whether it has to do with AI learning, whether that's like-to-like, whether it's using UBM or anterior segment OCT. And I think certainly in the second half of this year, we'll continue to have more clarity around how that gets to the marketplace, but already doctors are implementing some of the available tools that are available, not necessarily through STAAR, but physician to physician. And I think that is playing the role in doctors' confidence growing and their embracing of not only lens-based refractive surgery, but EVO ICL in particular.

Our next question today comes from George Sellers at Stephens Inc.

Maybe to switch gears back to China. I'm just curious, within your 10% growth expectation, could you just give us some additional detail on what that assumes from the market from the higher net ASP, Patrick, that you mentioned? And then also in the context of your new distributor what's the expectation for growth in contribution from Tier 3 and Tier 4 cities versus Tier 1 and 2 cities.

Yes. We haven't broken out that detail yet. And I think the way to think about the 10% is really focusing still on the Tier 1 and Tier 2. The opportunity is not just this year and beyond as more of those Tier 3 and Tier 4s. In terms of 10%, look, the market was in Q1, probably in China flat to even down. We don't have exact science on this, but depending on who you pull, we even heard numbers in the refractive market that might have been down minus 5%, minus 10%. So we clearly continue to take market share. We did see that [indiscernible] reported as a public company, they definitely saw some growth on the top line, but they saw tremendous growth on the bottom line. One could potentially say that there's a bit of a switch out where refractive is getting moved over to EVO because it is highly profitable for them specifically and for other customers in China. But I think overall, at 10% look, we're obviously holding [indiscernible]. Most of that is unit growth on a year-over-year basis. We did get some good economics out of the 2 distributors as part of the agreement that I mentioned, maybe a couple of hundred basis points of that 10% is related to that. And we're cautiously optimistic as we enter Q2, which is the beginning of the high season. And of course, the comps become a lot easier in the second half of the year.

And George, I would just add that our decision to add a second distributor was that 1 plus 1 is going to equal a hell of a lot more than 2, and it's a long-term play, and we're very pleased with how the second distributor has come up to speed and how both are working together collaboratively and complementing one another. So it's -- we feel we're very well positioned in that marketplace today and tomorrow.

Okay. That's really helpful. And then maybe on Europe and more broadly, EMEA, I think you mentioned an opportunity to potentially take some of the commercial initiatives and best practices that you've started to develop here in the U.S. and expand those more internationally. I'm just curious how you think about that opportunity, what kind of a difference what some of those particular best practices that you've developed or in the U.S. with getting doctors more comfortable with the procedure and the impact that could potentially have on some of your European market growth?

Yes. And again, we're very pleased with what's going on in EMEA. Again, a relatively flat market, and we saw nice double-digit growth there. And we do have a similar program called the [indiscernible] if you will. And we're seeing really nice growth in that select group of accounts, quarter-over-quarter and year-over-year. So the Highway 93 in the U.S., obviously, it was very U.S. specific, but we knew it would have tentacles that could be globally applied, and we're seeing that bear some fruit in Europe as we speak.

Yes. I think from a global standpoint, coming back to one of our vital view of focusing on surgeon confidence with the procedure. The papers that we talked about, we take a very global approach with that. One of the key papers that came out was actually authored by the U.S. doctor, a prominent doctor in Europe as well as in China. So you'll continue to see us take a very global approach. We understand that we are a global company and that we need to make sure that we're hitting all the KOLs globally in order to move the heat on those key geographies.

And our next question today comes from Steven Lichtman with Oppenheimer.

This is Ron on for Steve. Congrats on the great quarter. Just wanted to ask about some of the other U.S. initiatives you talked about in the investor meeting like the call center. How are those going? And are you still pursuing them?

Yes. No, thank you for the question. Yes, regarding the call center, again, we had said it was a pilot project. We currently ran it through a few months of the tail end of '24 through the first 3 months of this year. And I think we learned some things, but we certainly have made a pivot because we believe those dollars are better directed downstream to really surround our practices in a more effective way. So I think the pilot did what it was intended to do, to show us what we could learn. And we took those learnings and now are redirecting dollars more downstream and surrounding our customers with the various tools that we've developed over the last 6 to 9 months. So I would say the pilot did what it needed to do. It educated us but we've made a decision to pivot and direct those dollars in a more impactful way. As we said, we want to invest where investments are going to be rewarded, and we think more downstream support of our customers will bear the fruit and certainly begin to bear itself out in the Q1 results.

And then I was hoping you guys can provide some color on the gap between the sales growth and the unit growth between different countries and maybe how to reconcile that 9% sales versus 2% unit growth towards the small decline in gross margin?

Yes. The gross margin will be fine on that one. There were some inventory adjustments that we cleaned up some prior products that we no longer have on our -- that we actively sell. In relation to sort of the difference between revenue and units, look, we're getting some pretty good economics driven by China specifically. And that's really the one that's pushing the most. I would expect as we go into the next year, we'll call it, you'll start seeing that gap not be as wide anymore just because of the comps right now, we're working out the last year's numbers on an ASP standpoint. So we haven't taken that we have a cost increase in quite some time. And so that's always on the table, and we'll continue to think about that as we move not only through this year but as we move forward into next year.

Thank you. This concludes our question-and-answer session. I'd like to turn the conference back over to management for any closing remarks.

Yes. No, I want to thank you for joining us, and we look forward to keeping you updated on our progress.

Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.