STAAR Surgical Company (NASDAQ:STAA) Q1 2024 Earnings Call Transcript

STAAR Surgical Company (NASDAQ:STAA) Q1 2024 Earnings Call Transcript May 7, 2024

STAAR Surgical Company misses on earnings expectations. Reported EPS is $-0.06827 EPS, expectations were $0.05. STAAR Surgical Company isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: 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.

Brian Moore: 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, non-public 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?

Tom Frinzi: 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 months and his initial target under our new strategic agreement is 1,500 ICLs, representing significant growth over the prior year period. Last month, we engaged hundreds of surgeons at the ASCRS, the American Society of Cataract and Refractive Surgery’s Annual Meeting in Boston, where ICL was featured in 44 poster and paper presentations during scientific sessions at the meeting. At least 2 papers were presented that we believe will meaningfully increase surgeon confidence in the measurement of the eye in ICL lens size selection. We also launched STAAR University, our medical science website at ASCRS for surgeons and other healthcare professionals. STAAR University will feature clinical data and research, including the papers I just discussed.

And work is underway to further expand STAAR University’s features, including videos and the surgeon training portal. We also introduced our Stella ordering and planning system at ASCRS. Stella will enhance surgeon efficiency and practice flow and is the initial step towards a comprehensive EVO ICL ecosystem. We have drawn a line in the sand to be the choice for minus 6 and above as our next step in moving down the diopter curve, which represents a significant growth opportunity. When we surveyed surgeons with our clinical data at both ASCRS and our recent Asia Pacific Expert Summit, 93% of those surveyed agreed or strongly agreed that based on the data presented, they were more comfortable recommending EVO ICL for patients minus 6 and above.

And finally, in the first quarter, we reached and celebrated 3 million total implantable collamer lenses sold. Half of those ICLs were sold in just the last 3 years. Turning my attention now to our regional results for the first quarter of 2024. We generated ICL sales growth of 9% in the Asia Pacific region, including 10% growth in China. In the first quarter of 2024, the APAC region outperformed our full year fiscal 2024 outlook of 7% and China growth in the first quarter was ahead of our expectations despite a tough comp in the year ago quarter, which reflected pent-up demand following the removal of COVID-19 restrictions in the fourth quarter of 2023. We generated 11% sales growth in the EMEA region, which exceeded our outlook for flat sales growth for the full year fiscal 2024.

Growth was driven by the Middle East and our European distributor markets, which includes newer hybrid markets such as Belgium and the Netherlands, where we began investing just a few years ago and now have reached approximately 20% share in each market. In our Americas region, we generated sales growth of 12%, including 15% sales growth in the U.S., which also grew 21% sequentially. Our results in the U.S. outperformed our outlook for flat growth in the first half. And once again, we believe we have achieved a new base level of U.S. quarterly sales. We saw returns on our strategic investments in 2023 during the first quarter of 2024. As many of you may recall, it was just about a year ago when we began making critical investments to drive our business forward.

In April 2023, we made an investment in people, adding a Chief Operating Officer and a Chief Clinical Regulatory Medical Affairs Officer to our leadership team. In the third and fourth quarter, we added 3 new customer-facing vice presidents. And last week, we announced our new General Counsel and Chief Marketing Officer. These individuals are already having a positive impact on our business and will further accelerate EVO ICL uptake, our market share capture and innovation. We have invested in our field organizations globally with new hires in both large and emerging markets, including China, the U.S., India and Brazil. In China, for example, we expect to end the year with more than 100 STAAR employees as we lean into the growth opportunity in the largest market for refractive vision correction.

We aim to continue the strong business momentum we have achieved against the headwind of lower consumer discretionary spending. We have been disciplined in our investments, and as a result, have built a record level of cash on our balance sheet. We are confident that our business model is structured to continue to generate and build cash. Based on current trends, we are reiterating our fiscal 2024 net sales outlook range of $335 million to $340 million. We acknowledge the challenging and dynamic macroeconomic and geopolitical environment. But based on our stronger-than-expected first quarter results, we expect to be at the higher end of the range. Patrick?

Patrick Williams: 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 lean into investments to build the market for EVO ICL as we build a foundation for future growth and margin expansion in the later years of our strategic plan. Taking a closer look at the components of operating expenses. G&A expense for Q1 2024 was $23.2 million compared to $18.1 million in the prior year quarter and $16.9 million in Q4 2023. The year-over-year increase in G&A is primarily due to increased outside services and facilities costs. The sequential increase in G&A is due to compensation-related expenses and outside services.

For 2024, we continue to expect G&A expense to be approximately $24 million per quarter. Selling and marketing expense was $26.7 million for Q1 2024 compared to $26.4 million in the prior year quarter and $22.6 million in Q4 2023. The increase in selling and marketing expenses from the prior year was due to increased compensation-related expenses, trade shows and meeting expenses offset by decreased advertising and promotional activities. For 2024, we continue to expect selling and marketing expense will be approximately $30 million per quarter, which is consistent with prior periods as a percent of net sales. Research and development expense was $13.4 million for Q1 2024 compared to $10.3 million in the prior year quarter and $10.9 million for Q4 2023.

The year-over-year increase in R&D is due to compensation-related expenses. For 2024, we now expect R&D expense will be slightly higher at approximately $14 million per quarter, as we increase investments in our Department of Global Professional Education and Training as well as STAAR University. For Q1 2024, net loss was $3.3 million or $0.07 loss per share compared to net income of $2.7 million or $0.05 income per share in the prior year quarter. During the quarter, we had a $2.3 million loss related to foreign currency exchange, which drove the majority of our net loss in the quarter. This is related to cash generated from our Japan business, which requires us to mark all cash and investments back to U.S. dollar from yen, which has been weak at record levels versus the U.S. dollar.

Consistent with our previously communicated profitability expectations for the first quarter, we did have a GAAP loss in the quarter but significantly outperformed on adjusted EBITDA coming in at $5.3 million or $0.11 per share compared to adjusted EBITDA of $10 million or $0.20 per share in the prior year quarter. As a reminder, we introduced adjusted EBITDA as a profitability metric that we believe more accurately represents the underlying performance of our business model on an absolute basis and relative to our peers. We believe that an adjusted EBITDA financial metric or adjusted earnings before interest, taxes, depreciation, amortization and stock-based compensation, provides investors with an additional tool for evaluating the company’s core operating performance and a proxy for cash generation.

We use this non-GAAP financial measure in our own evaluation of operating performance and believe it is a more useful reflection of our progress. A table reconciling net income to adjusted EBITDA for prior periods is included in today’s financial release. In order to reconcile adjusted EBITDA from net income for our fiscal 2024 profitability outlook, we are providing the following line item details. Provision for income tax unchanged to be calculated using an effective tax rate of approximately 35% per quarter, subject to no significant change in our valuation allowance. We now expect other income expense to be slightly better at approximately $0 per quarter. Depreciation unchanged at approximately $1 million per quarter. Amortization unchanged at $0 per quarter.

And we now expect stock-based compensation to be slightly higher at approximately $8 million per quarter. As Tom said, we are reiterating our fiscal 2024 sales outlook range of $335 million to $340 million. So based on current trends, we do expect to be at the higher end of this range. For the second quarter of 2024, we anticipate net sales of approximately $95 million, which continues to contemplate above market rates of growth globally in all key markets. Based on our Q1 profitability performance and after mentioned changes to our income statement line items, we now expect our full year adjusted EBITDA will be approximately $3 million higher or $39 million and using approximately 52 million shares outstanding resulted in an adjusted EBITDA per share of approximately $0.75 up from $0.70.

Turning now to our balance sheet. Our cash, cash equivalents and investments available for sale reached a record $252.1 million at the end of the first quarter 2024 as compared to $232.4 million for the fiscal year-end 2023. This was better than anticipated in our preliminary announcement as was our progress on reducing accounts receivable to $64.6 million. Notably, this reduction in accounts receivable was related to our China business, and we are back to historical levels as a percent of sales across all customers globally. We look forward to meeting with many of you in the days and weeks ahead. We will participate in the Morgan Stanley Virtual Asian Conference next week and the Goldman Sachs Healthcare Conference in June. We will also participate in in-person investor meetings in Hong Kong, Shanghai, New York and Southern California.

We expect to report our second quarter results in early August. This concludes our prepared remarks. Operator, we are now ready to take questions.

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Q&A Session

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

Margaret Kaczor : 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.

Tom Frinzi: 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.

Margaret Kaczor : 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.

Tom Frinzi: 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.

Operator: Our next question comes from Tom Stephan with Stifel.

Tom Stephan : 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?

Tom Frinzi: 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.

Tom Stephan : 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.

Tom Frinzi: 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.

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

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

Patrick Wood: 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.

Tom Frinzi: 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.

Patrick Wood: 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?

Tom Frinzi: 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 out.

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

Young Li: 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.

Tom Frinzi: 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.

Patrick Williams: 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.

Young Li: 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.

Tom Frinzi: 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.

Patrick Williams: 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.

Operator: And our next question comes from John Young at Canaccord.

John Young: 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?