STAAR Surgical Company - Q1 2023

Transcript

Operator (participant)

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the STAAR Surgical First Quarter Financial Results conference call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the call will be open for questions. If you have a question, please press the star followed by the one on your touch-tone phone. If you are using speaker equipment today, please lift the handset before making your selection. This call is being recorded today, Wednesday, May 3rd, 2023. At this time, I would like to turn the conference over to Mr. Brian Moore, Vice President, Investor, Media Relations, and Corporate Development for STAAR Surgical. Please go ahead.

Brian Moore (VP of Investor Relations and Corporate Development)

Thank you, operator, and good afternoon, everyone. Thank you for joining us on the STAAR Surgical conference call this afternoon to discuss the company's financial results for the first quarter ended March 31, 2023. 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 and is now available on STAAR's website at www.staar.com. Before we begin, let me quickly remind you that during the course of this conference call, the company will make 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 described in the forward-looking statements. The risks and uncertainties associated with the forward-looking statement made in this conference call and webcast 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, to supplement the GAAP numbers, we have provided non-GAAP adjusted net income and adjusted earnings per share and sales in constant currency. We believe that these non-GAAP numbers provide meaningful supplemental information and are helpful in assessing our historical and future performance.

A table reconciling the GAAP information to the non-GAAP information is included in today's press release. For brevity, all references to growth rates on today's call refer to year-over-year growth unless otherwise stated. Following our prepared remarks, we will open the line to questions from publishing analysts. We ask analysts limit themselves to two initial questions, then re-queue with any follow-ups. We thank everyone in advance for their cooperation with this process. With that, I would now like to turn the call over to Tom Frinzi, President and CEO of STAAR.

Thomas G. Frinzi (President and CEO)

Thank you, Brian. Good afternoon, everyone, and thank you for joining us on today's call. The first quarter results we reported today illustrate continuing market share gains for our EVO ICL family of lenses, even as total refractive surgery procedure volumes are challenged or declining in many markets. Global ICL growth in the first quarter, up 20% for both sales and units, was broad-based across APAC, EMEA, and the United States. These strong results and the further momentum that we are experiencing globally confirm our confidence in the year. We are therefore raising our fiscal 2023 net sales outlook to approximately $348 million, which includes the approximate $3 million in other product sales we reported for Q1. Our raised outlook represents 28% ICL sales growth.

For the first quarter, global ICL sales of $70.6 million were $3.6 million above the high end of our $65 million-$67 million outlook. Results were driven by a restorative quarter for ICL procedures in China, which commenced in mid-January and has continued unabated. ICL unit growth in China was 20% for the first quarter of 2023. China indeed is back, and as a result, ICL procedures in China are certainly back. To deliver the strong results in China, our team hosted surgeon training events, academic conferences, and advanced practice development and consumer marketing activities, often in partnership with our surgeon customers. One live stream surgery training was attended by over 1,800 doctors and clinical staff. Another young surgeon conference was attended by over 1,300 doctors and residents.

A conference in collaboration with a key university hospital account was attended by over 3,800 ophthalmic doctors and clinical staff. Consumer marketing in-country was diversified across digital content channels and emphasized the sharp, clear, and high-quality vision provided by EVO ICL, as well as our custom toric lenses specifically developed for myopia with astigmatism. One marketing program with influencers received over 1 million views during the quarter. Two weeks ago, we hosted leadership from our largest customer in China, Aier Eye Hospital, at our Lake Forest, California, headquarters. During that meeting, Aier's leadership reinforced the importance of ICL to their overall growth strategy globally. As a region overall, APAC delivered solid performance, up 19% in units and 20% in sales for the first quarter of 2023.

In the United States, ICL units grew 78% for the first quarter, well ahead of industry volumes in the U.S., which the Refractive Surgery Council reported declined 9.1%. Sequentially, our U.S. sales in the first quarter were relatively flat. However, we are coming off a strong March and remain confident in our Q2 projections and the doubling of sales in the U.S. for the full year. During the first quarter, we executed on the planned infrastructure additions to our U.S. commercial organization, which we believe are important to driving growth and better serving our customers. The number of account executives, clinical application specialists, and practice development personnel across our U.S. commercial organization has markedly increased and will continue to grow in targeted markets when appropriate.

We expect our new team additions will become productive in the second half of 2023 and even more so beyond that. This month, we entered the eighth month of our direct-to-consumer-supported EVO launch in the U.S. Our DTC marketing efforts, which target potential patients primarily ages 21-35, are working to build awareness and the funnel of future ICL patients. In the first quarter of 2023, we saw a 402% increase in visits to our U.S. Doc Finder. We anticipate that these visitors will begin their journey of discovery, learning more about EVO and the ICL procedure for their Visual Freedom selection. I would like to share with you an email from one of our customers, who is a Surgeon CEO of a multi-centered chain of U.S. clinics.

The email reads as follows, and I quote, "I just wanted to let you and your team know that STAAR's marketing seems to be really paying off with EVO ICL. There's a lot more consumer awareness. For the surgeons and staff, it is less of a sell, and it's become quite easy to convert patients to surgery. Our volume is still relatively low, but I think it is because we are still targeting the higher myopes for ICL. Our surgeons and staff are getting more comfortable with EVO ICL.

We have reduced the number of appointments and patient anxiety by eliminating the need for laser peripheral iridotomy. This gives us comfort to reduce the level of myopia we are comfortable treating with ICL. Our plan is to make our website more EVO ICL friendly. Thanks to STAAR for having the foresight to do effective DTC marketing. Thanks to your whole STAAR crew for being forward-thinking and putting patients and doctors first." End of quote.

Another doctor, a young surgeon based in California, has increased his ICL utilization 6x over the past year to approximately 12% of his practice's procedure mix and tells me that he expects to move his -8 diopter cutoff even lower. This surgeon told me he expects to see ICL gain significant market share in the coming year. The anecdotes I just shared are just two examples that we're building the market for EVO ICL in the U.S. New and exciting influencer and customer co-marketing partnerships in the U.S. have or will soon be finalized. These investments are budgeted and consistent with the investments we talked with you about on our last call, which Patrick will also cover shortly.

Overall, based on my decades of experience in ophthalmology and my knowledge of our EVO ICL launch status, I'm quite pleased with where we are at this point in time. I'm confident that awareness, adoption, and selection by surgeons and patients will continue to accelerate in the U.S. Turning to our EMEA region, ICL units were up 18% in the first quarter, with sales up 10%, which were impacted by currency headwinds. Five of the six major regions we track in EMEA had positive growth in the first quarter as compared to just two of six regions in the fourth quarter of 2022. We saw standout growth in European hybrid markets where we have made investments. As a reminder, STAAR invested in its first European hybrid market in 2020 in the Benelux and then Italy and France in 2021.

These hybrid markets have consistently outperformed our pure European distributor markets. For example, in the first quarter of 2023, we saw year-over-year ICL unit growth in the Benelux up 34%, France up 20%, and Italy up 45%. The STAAR team globally is focused on executing against the targeted priorities that are important for our growth and to our customers and shareholders. In March, we added two highly regarded ophthalmic leaders to our team, Warren Foust as Chief Operating Officer and Dr. Magda Michna as Chief Regulatory, Clinical, and Medical Affairs Officer. We look forward to the contributions we are confident each will make for STAAR, our customers, and patients. The big picture growth drivers for our business remain highly favorable. First, the number of people with myopia continues to grow, which further increases our already large addressable market globally.

Millions of contact lens wearers stop wearing contacts every year due to intolerance, discomfort, hassle, and the like. Many of these former contact lens wearers have the ability to pay for EVO ICL. Second, we have an EVO procedure that offers surgeons favorable economics and profitability. Third, we have a great product that many patients have determined is a preferable solution which they have chosen to break free from contacts and eyeglasses. In early April, we completed a customer survey with just over 900 responses from our surgeon customers globally. In response to the statement, "I am satisfied with STAAR's surgical product quality and clinical outcomes," 99% of over 300 China surgeon customer respondents agreed.

In the U.S., 100% of approximately 100 U.S. surgeon customers responding agreed with the statement, "I am satisfied with STAAR's surgical product quality and clinical outcomes." EVO ICL is the real deal. When surgeons and patients are exposed to EVO, they overwhelmingly agree. Our focus is to make EVO the first choice for doctors and patients seeking Visual Freedom. We're confident we'll continue to drive faster and faster growth as awareness of EVO continues to rise. As I have said on many occasions, the time for EVO is now. Patrick.

Patrick F. Williams (CFO)

Thank you, Tom. Good afternoon, everyone. Total net sales for Q1 2023 were $73.5 million, up 16% as compared to the $63.2 million in net sales in Q1 2022 and up 15% on a sequential basis from Q4 2022 net sales of $64 million. The year-over-year increase in net sales is attributable to a 20% increase in ICL sales, partially offset by a 36% decrease in other product sales. ICL sales of $70.6 million represented 96% of total company net sales for the first quarter as compared to 93% of total company net sales in the year-ago quarter. Other product sales were $2.9 million for the first quarter.

We continue to expect other product sales will represent a smaller and smaller percentage of net sales as we move through fiscal 2023 and taper our support of the non-core cataract IOL business. Gross profit for Q1 2023 was $57.6 million, or 78.3% of net sales, as compared to gross profit of $49.3 million or 77.9% of net sales for Q1 2022 and $49.8 million or 77.7% of net sales for Q4 2022. The 40 basis point increase in gross margin as compared to Q1 2022 is primarily due to geographic and product mix, partially offset by increased period costs associated with manufacturing projects. The 60 basis point sequential increase in gross margin from the fourth quarter is due to the higher ICL sales mix in Q1 2023 and geographic mix.

For fiscal 2023, we continue to expect gross margin will be approximately 80% for the full year and each quarter. Moving down the income statement, total operating expenses for Q1 2023 were $54.8 million as compared to $37.2 million in Q1 2022 and $48.8 million for Q4 2022. Taking a closer look at operating expenses, total operating expenses for Q1 2023 were consistent with our plans, though we did have some expenses which we had anticipated to be sales and marketing that ended up being booked in G&A for Q1 and will continue moving forward. G&A expense for Q1 2023 was $18.1 million compared to $11.9 million for Q1 2022 and $14.8 million for Q4 2022.

The year-over-year increase in G&A is due to increased compensation-related expenses, including a $1.5 million severance expense related to our IOL business in Japan, outside services, and increased facilities costs. The sequential increase from Q4 2022 was due to increased compensation-related expenses, severance expenses related to our IOL business, and increased outside services. For fiscal 2023, we now expect G&A expense will be approximately $19 million per quarter. The increase from our prior outlook primarily relates to higher stock-based compensation and additional executive hires. Selling and marketing expense was $26.4 million for Q1 2023 compared to $17.3 million for Q1 2022 and $24.2 million for Q4 2022. The increase in selling and marketing expense from the prior year was due to increased advertising and promotional expenses, compensation-related expenses, and trade shows and meetings.

The sequential increase in selling and marketing expense was due to increased advertising and promotional expenses and compensation-related expenses. We continue to expect selling and marketing expense will be approximately $33 million for Q2 and each quarter for the balance of the year. Research and development expense was $10.3 million in Q1 2023 compared to $7.9 million for Q1 2022 and $9.8 million for Q4 2022. The year-over-year increase in R&D is due to increased compensation-related expenses and the U.S. EVO post-approval clinical trial expenses associated with the three-year study. The sequential increase in R&D is primarily due to increased compensation-related expenses. For fiscal 2023, we continue to expect R&D expense will be approximately $11 million for each quarter.

Operating income in Q1 2023 was $2.8 million or 3.8% of net sales, as compared to $12.1 million or 19.1% of net sales for Q1 2022. We anticipate other income will be approximately $1 million per quarter for the balance of the year. Due to the aforementioned growth investments and increase in stock-based compensation, we now anticipate operating margin for the fiscal year 2023 will be approximately 10% at the middle of the range of our five-year average. STAAR initially achieved positive annual operating margin and GAAP profitability in 2018, and we remain proud of our five-year track record of profitability and cash generation, which we expect to continue in 2023 and is rare for a high-growth medical device company.

Net income in Q1 2023 was $2.7 million or $0.05 per diluted share, compared to net income of $9.6 million or $0.18 per diluted share in Q1 2022. On a non-GAAP basis, adjusted net income for Q1 2023 was $8.7 million or $0.18 per diluted share, compared to adjusted net income of $14.4 million or $0.29 per diluted share in Q1 2022. A table reconciling the GAAP information to the non-GAAP information is included in today's financial release. For fiscal 2023, we continue to expect our effective tax rate will be approximately 25%-30%, subject to no significant change in our valuation allowance. Turning now to our balance sheet.

Our cash equivalents, and investments available for sale as of March 31st, 2023 totaled $217.3 million as compared to $225.5 million at the end of the fourth quarter of 2022. The decrease in overall cash is due to the timing of annual compensation payouts that occurred in the first quarter. We continue to expect we will invest approximately $26 million in property and equipment. We also anticipate generating positive cash from operations for the balance of the year and ending fiscal 2023 with a higher cash balance than fiscal 2022.

As Tom mentioned earlier, we today raised our net sales outlook from $340 million to approximately $348 million for fiscal 2023, including approximately $345 million of ICL sales and an approximate $30 million U.S. ICL sales contribution. For Q2, we expect total ICL sales to be approximately $93 million, including sequential sales growth in China and a U.S. sales of approximately $5.5 million. We anticipate generating approximately 47% of our fiscal 2023 ICL sales outlook in the first half of the year and 53% in the second half of the year. Finally, this Friday, May 5th, STAAR will host a surgeon lunch and panel during the American Society of Cataract and Refractive Surgery, ASCRS, conference in San Diego.

Please reach out to Brian Moore in Investor Relations if you would like to attend. STAAR will also be participating in The Benchmark Company Virtual Healthcare Conference and Barclays Southern California Investor Bus Tours, both on May 23rd, the William Blair Annual Growth Conference in Chicago on June 6th, and the Sidoti & Company Virtual Investor Conference on June 14th. This concludes our prepared remarks. Operator, we are now ready to take questions.

Operator (participant)

Thank you. As a reminder, if you'd like to ask a question, you can press star followed by one on your telephone keypad. If you'd like to withdraw your question, you may press star followed by two. Please ensure you're unmuted locally when asking your question. Our first question for today comes from Anthony Petrone from Mizuho Group. Anthony, your line is now open. Please go ahead.

Anthony Petrone (Managing Director and Senior Equity Research Analyst)

Thank you, and congratulations here on a strong first quarter result. Maybe, Tom, I'll start with just the performance in China, obviously describing it as back to, you know, normalized levels. A couple of follow-ups here would be, you know, one, as we look into the seasonal peak, the normal seasonal peak, which would be 2Q and 3Q, how does it play out this year versus prior years? Is there any backlog that's gonna be also in that number? I'll have a follow-up for Patrick. Thanks.

Thomas G. Frinzi (President and CEO)

No, Anthony, good to hear from you, and thank you for the question. China is indeed back, and we anticipate Q2 and Q3 being equally as strong. As we enter into the high season, we're poised for a good run in China.

Anthony Petrone (Managing Director and Senior Equity Research Analyst)

Excellent. Maybe just a quick one if I could sneak it in there. Can you provide maybe the data on where ICL is as a percent of total refractive in China and maybe the aspirational target? The quick one for Patrick would be just the sales and marketing expense ramp this year was actually a little bit lower than we expected in 1Q. Just wondering how we should be thinking about it as the year progresses. Again, thanks and congratulations.

Thomas G. Frinzi (President and CEO)

Sure. From a market share point of view, again, I think it's a moving target as we look to kind of confirm the number of refractive procedures, but I think we're comfortable that we're around 20% and growing.

Patrick F. Williams (CFO)

Anthony, on my side, as per my prepared comments. We did have some expenses that we thought were going to be in sales and marketing when we gave the original guidance back in late February. We ended up booking those in G&A. We also saw a slight increase in stock-based compensation. As I said, we're at about $33 million a quarter in absolute dollars for sales and marketing, and that was. You'll see in Q2, Q3, and Q4. I think, if you guys go back and reference the prepared remarks, it should get the models very much in line.

Anthony Petrone (Managing Director and Senior Equity Research Analyst)

All right. Thanks again. I'll hop in queue. Thanks.

Operator (participant)

Thank you. Our next question comes from Margaret Kaczor from William Blair. Margaret, your line is now open. Please go ahead.

Margaret Kaczor Andrew (Partner and Medical Technology Analyst)

Hey, good afternoon, guys. Thanks for taking the question. I wanted to start on guidance, if I could, specifically on the U.S. side. First, you know, can you confirm the Q1 number, you know, being maybe close to $4.5 million if it's flat sequentially, and then maybe you're up, it sounds like maybe $1 million sequentially in Q2 to $5.5 million. I think you also referenced maybe doubling by the end of the year, which gets me to about $9 million. I just wanted to walk through that and make sure that I'm thinking about that correctly. And if you could provide any drivers around that'd be useful. Thanks.

Thomas G. Frinzi (President and CEO)

Yeah, sure. Thanks, Margaret, for the question. I'll let Patrick add his color as well, but your assumptions are correct in both what we think will happen in Q2, where Q1 was, and we're remain confident that we'll double our business in the U.S. for the entire year, 2023. We're encouraged by some of the metrics we look at such as, you know, Doc Finder visits continue to go up. In Q1, they were up over 400%. We continue to see very good conversions on a day-to-day basis of doctors committing more and more of their total refractive procedures to EVO ICL.

Margaret Kaczor Andrew (Partner and Medical Technology Analyst)

Great. Appreciate that. You know, maybe going a little bit deeper right on the U.S. side, I really appreciate the additional examples you provided in terms of the few calls on accounts and going down on the diopter curve. You know, we've heard the same. Maybe, Tom, you could speak to kind of the most important or maybe even most successful practice development initiatives for the next few quarters. I guess when do you expect them to have a more material impact on utilization, particularly in those borderline EVO accounts? Thanks.

Thomas G. Frinzi (President and CEO)

Yeah, sure. Margaret, as you know, change takes time, and we're seeing that in the U.S. We're confident as we have made the investment in practice development and adding headcount and quota-carrying salespeople and clinical apps people. We're starting to see that bear fruit. I can tell you almost on a weekly basis, I get calls from end users that are really pleased with their outcomes. They're continuing to push the diopter trend down. They're continuing to see brand awareness, people coming in, asking for EVO. I think as we continue to monitor those, I remain very confident that, you know, each month, we're cracking the code more and more and, you know, we remain very optimistic and confident that the U.S. is gonna be where we want it to be.

Margaret Kaczor Andrew (Partner and Medical Technology Analyst)

Okay, great. Thank you.

Operator (participant)

Thank you. Our next question comes from Ryan Zimmerman of BTIG. Ryan, your line is now open. Please go ahead.

Sam Durno (Equity Research Analyst)

Hi, guys. This is Sam on for Ryan, thank you for taking my questions. This one's on the 2023 operating margin guidance. You brought down operating margin expectations to 10%, but have also previously commented that spend will ramp into 2024. Right now, the street is sitting at around 17.8% operating margins in 2024. I know you're not going to guide to 2024, but what are your thoughts on that 2024 street consensus operating margin expectations? Do you think it's too high or too low given the spend in the U.S.? I have a follow-up, too. Thank you.

Patrick F. Williams (CFO)

Sure. Yeah, we're not going to comment as you said on 2024. You know, we'll take a look as we continue to move through the quarter to see if we want to give some color, as we move through this year and going into 2024. As I mentioned, you know, the primary driver was a non-cash adjustment on the operating income, which was stock-based compensation. Some of the other metrics that we look at internally, and I know a lot of the street does as well, is, you know, what are we doing with op cash flow, free cash flow, and certainly more of an adjusted EBITDA type number.

When I look at those, I'm very satisfied with where we're going, and we'll hold off on, you know, anything going into 2024 now. You know, we want to make sure that we're investing appropriately and being able to grow the U.S. commercial specifically, but you know, honestly, the 95% of the other revenue across the world, where we still have very low market share.

Sam Durno (Equity Research Analyst)

Thank you. That's really helpful. As we look ahead for the remainder of 2023 into 2024, how are you thinking about the impact of competition with the development of some domestic ICL companies in China? Thank you.

Thomas G. Frinzi (President and CEO)

Yeah. Sam, thanks for the question. Again, we really don't see competitive forces impacting our ability to continue to grow in China. I think 2 million implants sold worldwide. The safety, the efficacy of our technology has been well established, and we see that continuing to move forward unabated.

Patrick F. Williams (CFO)

Just to clarify, just so we're clear, I heard you say domestic, so I want to make sure we're if you were talking China or the U.S. We are a PMA device. If anyone is gonna do something here in the U.S., there's a long road to go as well as high investment dollars on that.

Sam Durno (Equity Research Analyst)

Thank you.

Operator (participant)

Thank you. Our next question comes from Bill Plovanic from Canaccord. Bill, your line is now open. Please go ahead.

John Young (Research Associate)

Hi, Tom, Patrick, it's John on for Bill this evening. Thanks for taking our questions. I'll probably circle back to the U.S. where a lot of the focus is, it was a little bit lighter than the original guidance you had put out last quarter. Just a little bit more color on what you saw in the quarter. I know you said you saw a strong March, but could you talk a little bit about any productivity gains you're seeing and how many of the planned 10 reps you had mentioned in the last call were hired, and just what do you expect for productivity out of those 10 hires? Thanks.

Thomas G. Frinzi (President and CEO)

Yeah, no, I appreciate the call. Certainly we have filled, I think about 90% of those job openings that we had posted and talked about in previous calls, we feel good about the quality of the people we've attracted. I think as we've said previously, it'll take a quarter or two for those people to be very productive. We feel good about the second half of the year. I think March was a strong month. April, we continue to see conversions happening, which gives us confidence in where we think Q2 will be and the fact that we reiterated that we believe we will double our business for the year in 2023.

You know, again, in my years of being in this ophthalmic business, you know, when you're creating a market and growing a market, it takes time. Quite frankly, we're right where we need to be. When you think about it, even though we were approved a year ago, we're really only about six to seven months into our launch mode when we really started to gear up our direct-to-consumer spend and creating brand awareness, increasing our infrastructure.

When you look at it from that viewpoint or that context, I think we're right where we need to be. I feel very confident as we keep growing month to month to month. We're right where we need to be and we remain confident that the U.S. is growing at the rate it should be. Put that in further context, when you think about where we were in China, back in 2016, we're growing at a rate in the U.S. greater than we were in China at a similar point in time. Again, another reason for being confident.

John Young (Research Associate)

Great. Thanks. Just maybe to go a bit deeper into that strategy, can you talk a little bit about any context around KOL engagement, which I know is a new focus for you, Tom, and then also just the new account versus go or deep strategy and just how many surgeons today are trained? Thanks.

Thomas G. Frinzi (President and CEO)

Surgeons trained today are approaching, I think, 650-700 in that range. As I said, we're more focused on going deeper than wider. Obviously, demand's gonna be there. We'll certify new surgeons as that demand comes in. We're really trying to concentrate on ensuring the surgeons that are already certified to do EVO ICL are surrounded with practice development support, clinical application support, and quota-carrying sales support to ensure they really are reducing this into the fabric of their practice and moving towards being the first choice when it comes to patient seeking Visual Freedom. We're not there. That's our aspirational goal. We think we have the people, the programs and the process to get us there.

John Young (Research Associate)

Thank you.

Thomas G. Frinzi (President and CEO)

Thank you.

Operator (participant)

Thank you. Thank you. Our next question comes from Young Li of Jefferies. Your line is now open. Please go ahead.

Young Li (SVP of Equity Research)

All right, great. Thanks for taking our question. Maybe first one for Tom, just on the quote in the press release about EVO increasingly becoming a patient's first choice. Where are you seeing that? You know, is there an inflection point in terms of patient awareness or surgeon experience?

Thomas G. Frinzi (President and CEO)

Well, I mean, thank you for the question. I would say the fact that we're growing, we're up 70%+, you know, year-over-year suggests that more and more patients are walking in the door and more and more docs are starting to convert. As I said, our aspirational goal is to be the first choice. We're not there yet. You know, the inertia of LASIK is real. Laser Vision Correction has been around a while, EVO is very early in its launch phase in this particular market in the U.S. As previously stated, I think we're right where we need to be. I remain confident, as previously stated, that we're right where we need to be. We're growing, we have momentum, and we really feel good about the U.S. growth.

Patrick F. Williams (CFO)

I'll just add, we're, you know, we're about to go to ASCRS here, and we're gonna be doing a surgeon panel there on Friday, which we talked about. I think, people are gonna be excited to hear the takeaways from that, you're gonna start hearing a lot more doctors talk about exactly what you just asked Young, which is that they're thinking EVO first when a patient walks in the door asking for refractive surgery.

John Young (Research Associate)

Okay, great. Looking forward to that. I'll be there. Maybe for the follow-up, for Patrick, I guess. You know, it's been a little bit more than a year since the U.S. approval. You know, just high level, you know, how do you think the U.S. launch is going relative to your expectations? You know, what's going better than expected, or what's been a little bit more challenging than expected?

Patrick F. Williams (CFO)

Yeah, I think Tom hit the nail on the head, right? Whenever you're trying to launch into a new market, you learn as you go along. I think what you heard in the prepared comments now is a definite focus from Tom on voice of the customer, and listening to that and trying to figure out what are those things that we need to knock down in order to make EVO the first choice. You know, I'm very pleased with where we're at. We're better today than we were yesterday and certainly a year ago, and we're feeling really good of how we're starting off and excited about how the year will end up.

Young Li (SVP of Equity Research)

All right. Thank you.

Operator (participant)

Thank you. Our next question comes from David Saxon of Needham. David, your line is now open. Please go ahead.

David Saxon (Senior Analyst)

Yeah, thanks. Hi, Tom. Hi, Patrick. Congrats on the really strong quarter. Thanks for taking my questions. Maybe I'll start with one on the U.S. I mean, by my math, I think you're tracking right around 3% volume share. That's for the whole market. I want to ask, is that what you're seeing internally? Since you're taking the approach of going deep versus wide, can you talk about the share ramp you see, you know, once you do get into an account?

Thomas G. Frinzi (President and CEO)

You know, look, I would say that our you know, the goal I put out for the team, let's put it that way, is I think we should be going into accounts thinking we should earn our way to 50% of their total refractive procedure volume. Are we there today? No, absolutely not. Do we have practices that are approaching 20%-25% of their refractive procedures are EVO ICL? Yes. We're continuing to grow those types of practices.

As I said, you know, when you're creating a market, when you're changing a market, when you're moving the inertia of LASIK, it takes time. I think that this EVO launch is gonna be no different. I'm not discouraged at all by anything we're seeing. Quite frankly, just the opposite, I'm encouraged, as I've had dinner meetings and phone calls with KOLs across the country. They're excited about what STAAR is doing and how EVO is performing.

David Saxon (Senior Analyst)

Okay. That's helpful.

Thomas G. Frinzi (President and CEO)

Further testimony to that. Let me just make one final comment for you. As further testimony to that, our top 30 customers that we stay very close to are up 2x year-over-year. Again, we're seeing the kind of growth we wanna see, and it, you know, keeps us feeling very bullish about the future.

David Saxon (Senior Analyst)

Okay. That's super helpful. Thanks for that. In the script, I think you talked about in Europe, you're seeing hybrid markets grow faster than distributor markets. I wanted to ask, you know, how big of a growth opportunity is that, you know, to get more of your distributor markets converted to hybrid markets? Maybe I'll tack on another one for Europe. Maybe just talk about the Viva launch. I think that was launched in September, you know, how is that going? Thoughts on, you know, the timeline for Viva getting into the U.S. Thanks so much.

Thomas G. Frinzi (President and CEO)

You know, look, I think hybrid versus distributor, it's depending on the market and, you know, what we find, we're trying to be responsive to what moves the market the most. As we said in the prepared remarks, we're very pleased with what we've seen in Benelux and France and Italy. It doesn't mean that our distributor markets aren't performing, but we're very pleased with those three in particular, and that's where we've put some investment dollars to work, and it seems to be bearing fruit.

I'm glad you mentioned EMEA because, again, I get that a lot of you are focused on the U.S. Quite frankly, you know, we're a global company, and we're continuing to grow around the world. China, Asia-Pac in general had great quarter. Europe had a great quarter. The U.S. is continuing to grow, and I think it speaks to the excitement of EVO around the world.

David Saxon (Senior Analyst)

Great. Thank you.

Patrick F. Williams (CFO)

Thank you.

Operator (participant)

Thank you. Our next question comes from Steven Lichtman from Oppenheimer. Steven, your line is now open. Please go ahead.

Ron Feiner (Equity Research Associate)

Hi, guys. This is Ron on for Steve. wanted to ask on China, continuing to see really great growth, how long do you guys think this high growth can continue? I mean, obviously, China is a very big part of STAAR's revenue. How far do you guys think the refractive market over there is going to shift in your favor? Do you have any targets and trends like that in other countries that would be similar? Thanks.

Thomas G. Frinzi (President and CEO)

You know, I think the runway is big in China. You know, we're well established there, but boy, we have great opportunity for continued growth. China is back, as we said earlier. All indications are, it's back to normal levels. We're seeing very good in-country demand. So, the sky's the limit.

Patrick F. Williams (CFO)

I'll just add on that one. I think one of the big things that we talked a little early is what the total adjustable market size is. We are now talking more along the lines of 1.5 million to 1.6 million eyes. We just had our largest customer here, the Aier Eye Hospital Group, as Tom talked about in his prepared remarks. They supported that. In fact, we're starting to hear numbers that are even higher. They're approaching that 2 million, and we're obviously trying to vet some of that out. We very much have a long runway, as Tom just said.

Ron Feiner (Equity Research Associate)

Okay. Thanks, guys. One follow-up. Sorry if I missed this on diopter range. We know the recommendations are changing, change between countries, and they keep getting updated and going down and down. Can you tell us what trends you're seeing generally across as you look at your markets with regard to ICL use in lower diopter ranges, and are you seeing ICL use growing in lower diopter ranges anywhere specifically, maybe any trends in the U.S. that you could talk about?

Thomas G. Frinzi (President and CEO)

No, you know, I don't know if it's appropriate to speak on trends, but what I will tell you is as surgeons gain confidence and more experience in the use of EVO ICL, they naturally begin to start coming down that diopter curve. You know, our pivotal trial in the U.S. was, I think, the average diopter treated was a -7. You heard in my prepared remarks, you know, some people have arbitrarily established a -8 as kind of that cutoff period when they, you know, think LASIK versus lens-based refractive surgery. We're seeing more and more -3s, -4s, -5s being treated. I think, the trend is moving down, but I think it's predicated on gaining the experience, seeing the confidence of happy patients, happy staff, happy surgeon usually equates to coming down the diopter curve.

Ron Feiner (Equity Research Associate)

Okay. Thank you, guys.

Thomas G. Frinzi (President and CEO)

Thank you.

Operator (participant)

Thank you. Our next question comes from George Sellers of Stephens Inc. George, your line is now open. Please go ahead.

Harrison Parsons (Research Associate)

Hey, guys. This is Harrison on for George. Good afternoon. Thanks for taking the question. My first was about, as you see the U.S. surgeons ramp in utilization, I was wondering where specifically you see investment opportunities to drive that utilization higher, and how does that investment compare to what was needed in China during the early days of that launch?

Thomas G. Frinzi (President and CEO)

Yeah, I, you know, I wasn't here when the early days of China, but I would tell you the investment that we've put forward relative to this year is appropriate, and we're confident in the return on that investment. I think, you know, our monies are being well utilized at this stage of where we are in the U.S., versus, you know, when we started that process in 2016 in China.

Harrison Parsons (Research Associate)

Got it. Yeah, that makes sense. Secondly, I was wondering, in order to convert the U.S. practices from a laser-based practice to a lens-based, you know, practice, what are some of your biggest hurdles, and where have you found the most success? I know you've had a lot of success in the direct-to-consumer campaign, reaching the million viewers, but anything on the surgeon awareness side we should be aware of?

Thomas G. Frinzi (President and CEO)

You know, again, I really don't think it's a or situation. I think it's an end situation. I think EVO ICL, it fits very well into a comprehensive refractive practice. It doesn't have to be, is it LASIK or is it EVO ICL? That's why we're trying to build brand awareness, so patients are coming in inquiring about it. We're spending time educating and training surgeons, so they're comfortable offering a range of modalities to meet the needs of a practice. Clearly the fact that you can maintain the quality of the cornea, you're not severing corneal nerves, it's removable, et cetera. You know, patients like that story. As practices, see those kinds of outcomes manifest in their patients post-operatively, their confidence level goes up, particularly at the staff level.

The staff level gets more and more comfortable. you know, the surgeon becomes even that much more comfortable, and you begin to see that inflection point. Are we there in the U.S. as we are around other markets globally? No. Are we approaching that? Yes. And I think Q2 will be stronger, Q3, Q4 as we move into 2024. Again, if you use our international experience, in particular China, it was about a 2.5-year process, as I've stated. And we're about, in my mind, six, seven months into it. We have about a two-year run to really get to that inflection point, and I think we're right where we need to be and confident that we're going to be able to achieve that.

Harrison Parsons (Research Associate)

Great. Yeah. Thank you. Congrats on the quarter.

Thomas G. Frinzi (President and CEO)

I appreciate it. Thank you.

Operator (participant)

Thank you. Our next question comes from Thomas Stephan from Stifel. Tom, your line is now open. Please go ahead.

Thomas Stephan (VP of Medical Technology and Supplies)

Great. Hey, guys. Thanks for the questions. hopping in between calls, so apologies if some of these were asked. I wanted to start in China. Tom, if you wanna maybe elaborate a bit more on kind of trends to date and what you believe the slope of the recovery there year to date has looked like, I guess, the past two to three months, or maybe how did April look relative to March? As a follow-up to that, where do we stand in terms of the recapture of the procedures that had to be deferred in 4Q 2022 and early 1Q 2023? I guess if this is still ongoing, you know, when do we think we see that backlog benefit ultimately work down, if not already? I have a follow-up.

Thomas G. Frinzi (President and CEO)

I, thanks Tom for the questions. I would say that as it relates to the backlog, the fact that we saw some really record levels of end market procedures in Q1 would suggest to me that, if there was a backlog, it's being handled. You know, well, we had a very strong Q1 and as stated, you know, we remain very confident that Q2 and Q3 as we enter into the real high seasons in that particular market, we're very well positioned to have record quarters.

You know, the growth has been very consistent as we previously stated. You know, February is much stronger than January. March was much stronger than February. We're coming off of a really solid April. We think Q2 is gonna be really strong, and then obviously the real high season kicks in July, August, into early September. We continue to feel good about where China is.

Patrick F. Williams (CFO)

I'll just add, Tom, there's some sensitivity, right? I just want to make sure the question is we understand it completely. It is a challenge sometimes to figure out if, you know, if there was someone that put off a surgery back in the Q3, Q4 when there was the no COVID policy. As Tom said, we're off to a very good start in Q1, record-breaking quarters, and we're off to a great start in Q2. In our minds, you know, things are moving along there, and as we've said with China, it is just a very, very robust market. Affirmed once again by what we said in the prepared comments of our biggest customer being here a couple weeks ago and reiterating their focus and their investment into continuing to build that market for ICL, EVO specifically.

Thomas Stephan (VP of Medical Technology and Supplies)

Very helpful. Makes sense. I wanna shift to the U.S., I'm sorry to harp on this, but Tom, you've given and Patrick, a lot of really good color, but the U.S. came in a bit below for 1Q, and I think 2Q also looks light, at least versus our estimates. You are encouragingly reiterating the full year 2023 guidance. It does imply a pretty meaningful 2H inflection, basically doubling of sales and utilization. I guess what I'm asking is what gives you that confidence, just given the start of the launch, you know, maybe hasn't ramped really in that upward direction that maybe some people had hoped.

You know, I know there's docs on your metrics and investments you're making, but it's still a pretty significant number implied for 2H, especially with the docs train numbers slowing down a bit. You know, what gives you confidence in that 2H inflection? I wanted to ask about 1Q in particular. Tom, you called out, I think, a strong March, but you guided to the $5 million in late February. I'm just curious where the disconnect is in terms of the slight miss on the, on the 1Q guide. Thanks.

Thomas G. Frinzi (President and CEO)

Sure. Again, appreciate the question. I think, you know, confidence comes from certainly my years of launching different technologies in ophthalmology and knowing what it takes, and I think we're doing all of the right things in terms of where we've made investments, how we're surrounding customers, and it's being well-received. Our DTC spend is having an impact.

Where we are spending dollars in targeted cities, we're seeing the kind of growth we wanna see in those targeted cities. It gives us confidence that we have the right people, we have the right programs, and we have the right processes in place that are gonna bear fruit. I would agree with you, it puts a big number on the back half of the year. You know, we think we're doing the right things to be able to pull that off, and it's just gonna take time, right? I think the other part of your question was, I think relative to Q1 or Patrick-

Patrick F. Williams (CFO)

Relative to March.

Thomas G. Frinzi (President and CEO)

Yeah.

Patrick F. Williams (CFO)

Yeah, relative to March. Look, it's a, it's a fair comment, Tom, what I would tell you is, we were very pleased with where we ended March in. Clearly, it was a little shy of what we had told the Street at approximately $5 million. I know that you've heard from me, you've heard from Tom, Brian as well, that when you're launching a product like this, you know, $200,000 here or there doesn't make or break us, right? We believe that we're continuing to do the right things. You are right about the ramp-up in the second half, but we're confident in what we saw and clearly, we've had internal discussions on this and we came through and gave a number for Q2, which we hadn't given before. It does imply a doubling in the second half, and we're sticking with the approximately $30 million for the full year.

Thomas Stephan (VP of Medical Technology and Supplies)

Got it. Thanks for taking the questions.

Thomas G. Frinzi (President and CEO)

Yes, sir. Appreciate it, Tom.

Operator (participant)

Thank you. Our next question comes from James Sidoti from Sidoti & Company. James, your line is now open. Please go ahead.

James Sidoti (Analyst)

Hi, good afternoon. Thanks for taking the questions. You know, I know you said other products are being phased out, but you did have about $3 million in revenue in the quarter. Was that higher than you thought it would be?

Patrick F. Williams (CFO)

Yeah, we a little bit higher than we thought. I think as we started talking about exiting the business, clearly customers wanted to buy more. We thought this would spread out into Q2 and maybe even into Q3. As a reminder, James, our guidance did not imply any other product IOL business. It's low margin. It doesn't add a lot to the bottom line. Yeah, definitely, you know, we'll take the revenue for sure.

James Sidoti (Analyst)

Okay. Then on, you know, if I look at the guidance updated today relative to where you were at the end of the year, the only real change is on the G&A line, which looks like it's gonna be up, you know, maybe, $8 million or $9 million from where you thought it was gonna be when you last gave guidance. Is that all related to stock-based compensation?

Patrick F. Williams (CFO)

Primarily, we did talk about the fact that we added a couple executives as well and some of the other infrastructure things. Yeah, it's a high majority of it is stock-based compensation. You did hit the nail on the head. It's a little bit of an increase in G&A, and I give ourselves a little bit of wiggle room maybe in that number for the full year, but there's not a lot of modeling changes for sure.

James Sidoti (Analyst)

Right. Other than, you know, the upside of revenue, in this quarter and the change in G&A, it seems like your guidance is pretty much exactly the same as it was the last time you issued it.

Patrick F. Williams (CFO)

I would say that we upped our guidance on the revenue side, clearly, right? We're feeling good about that. That, if you wanna say that was the beat associated within Q1, then we can debate that. You are correct. On the rest of the model, we kept margins, OpEx, everything else, very steady.

James Sidoti (Analyst)

Okay. All right. Thank you.

Operator (participant)

Thank you. Our next question comes from Bruce Jackson of The Benchmark Company. Bruce, your line is now open. Please go ahead.

Bruce Jackson (Equity Research Analyst)

Hi. Thanks for taking my question. I was hoping to get some clarification on the pacing of the sales guidance. Historically, second quarter is, like, super strong, and then it trails off for the rest of the year. This year, do you think that the U.S. is gonna contribute to the revenue growth where it's up sequentially for the rest of the year? Can you give us a little help on the back half of the year for the sales guidance?

Patrick F. Williams (CFO)

Yeah. We talked about the second quarter, all in being approximately $93 million, with the U.S. being 5.5. I think as you model that out, at least when I was looking at some of the models, you're not gonna see perhaps the large or the outsized Q2 as compared to the other three quarters in the year. Some of that has to do with what we've been talking about quite a bit on the call now, which is the U.S., by math, has to do about $20 million in the second half. That's what's sort of making up for what I would call a more even spread of revenue to hit that $348 between Q2 to Q4.

Bruce Jackson (Equity Research Analyst)

Okay, perfect. Thank you.

Operator (participant)

Thank you. At this time, we have no further questions. I'll hand back the call to Tom Frinzi for any closing remarks.

Thomas G. Frinzi (President and CEO)

Thank you, Operator, and thank you for joining our call today. We look forward to speaking with many of you later this week at the ASCRS meeting in San Diego and our other upcoming events in the days and weeks ahead. Thank you.

Operator (participant)

Thank you all for joining today's call. You may now disconnect your line.