Staar Surgical (STAA) Q1 2022 earnings call transcript

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 April 1, 2022. On the call today are Karen Mason, President and Chief Executive Officer, and Patrick Williams, Chief Financial Officer. The press release of our first quarter results was issued just after 4 p. m. Eastern Time and is now available on STAAR's website at www. star. 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 statements made in this conference call and webcast The last few months of the STAAR's broadcast 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. Following our prepared remarks, we will open the line to questions from publishing analysts. We ask analysts to limit themselves to two initial questions, then re-queue with any follow-ups. We thank everyone in advance for their cooperation with this process. And with that, I would now like to turn the call over to Karen Mason, President and CEO of STAAR.

Thank you, Brian. Good afternoon, everyone, and thank you for joining us on today's call. The first quarter results we reported today represent another quarter of record sales, record ICL units, and profitable growth as we successfully raise awareness and enthusiasm for the visual freedom provided by our EVO family of lenses. We're particularly excited about the enthusiastic adoption by surgeons first to be trained in the US following recent FDA approval of our EVO family of lenses for myopia. The first US EVO patient implants occurred within days after approval. We enjoyed a strong commercial introduction of our EVO lenses less than two weeks ago at At the largest industry trade show in the US, ASCRS. At ASCRS, we shared for the first time the safety and effectiveness of the EVO lenses achieved during the pivotal trial.

Surgeon enthusiasm throughout the trade show was palpable. The case for EVO and STAAR as the first choice for refractive vision correction by our surgeon customers, consumer patients, and investors continues to grow stronger. For the first quarter of 2022, global ICL unit growth was up 26% year over year. By geography, we achieved strong ICL unit growth in China, up 37%, Japan, up 35%, India, up 34%, Asia-Pacific distributor markets, up 43%, and Latin America, up 41%. All as compared to the prior year quarter. At the end of March and subsequent to the end of the first quarter, China, the largest refractive market globally, and also our largest market, began to implement COVID-related lockdowns in multiple cities, resulting in a delay of refractive surgeries in various provider locations in China.

In other parts of China, refractive surgeries have continued. Overall, shipments of EVO lenses to China have remained robust as our distributor seeks to build inventory in anticipation of the peak summer implant season. Our China STAAR team continues their work in person where possible and virtually in cities that are locked down. As some of you may recall, we and our surge in customers have demonstrated flexibility and the ability to successfully navigate previous COVID-related pauses, which is also our goal during this current period. Based on our global demand forecast, including projected release of remaining backlog lenses, we are today reaffirming our previously provided outlook for annual sales. For fiscal 2022, we continue to anticipate approximately $295 million in net sales, which represents year-over-year growth of 28%.

Turning to the U. S. , the data from our EVO prospective pivotal trial supported the clinical evidence and clinical experience surgeons have reported globally. As previously announced in March, we are absolutely thrilled. We achieved FDA approval for our EVO family of myopia lenses for the U. S. Our team is energized by refractive surgeon enthusiasm in anticipation of offering the EVO lenses to their patients. For example, one prominent surgeon in the U. S. complimented our team at the recently held ASCRS Congress in Washington, D. C. He practices in a very large market in the U. S. and credited our consumer patient outreach for his upcoming surgery schedule consisting of 50% of his procedures being EVO versus laser vision correction.

He was amazed by this early uptake. As this is just the beginning of a multi-pronged approach to properly attracting patients to surgeons offering our EVO lenses, we believe it does bode very well for our ability to reach patients in the second largest refractive surgery market in the world. Our medical monitor for the US EVO pivotal trial, Dr. Mark Packer, recently presented the clinical trial data at the American Society of Cataract and Refractive Surgery Annual Meeting in Washington, D. C. Key findings from 629 eyes of 327 subjects implanted with EVO lenses in the trial were as follows. With regard to safety, no eyes experienced pupillary block, and there were no instances of anterior subcapsular cataract. Conclusion, the central port design of Vivo lenses functions effectively to allow physiologic flow of aqueous and prevent pupillary block, thus eliminating the requirement for preoperative peripheral iridotomies.

With regard to effectiveness, outcomes at six months postoperatively were as follows. 98.9% of eyes were within plus or minus one diopter of target. 98.5% of eyes achieved postoperative corrected distance visual acuity CDVA at six months equal to or better than preoperative CDVA. We believe, based on the data from our US clinical trial and more than 100 clinical papers supporting the safety and or efficacy of EVO lenses and the commercial success of the now more than 1.5 million EVO lenses implanted outside the US, that EVO is a phenomenal, game-changing product. Evo lenses offer patients visual freedom from glasses and contact lenses, excellent vision day and night, no dry eye syndrome, no corneal reshaping, and are removable if desired along with other benefits.

For our surgeon customers, particularly in countries such as the U. S. , where laser vision correction has declined, EvoLenses offer the opportunity to grow the number of refractive procedures to previous peak levels and beyond with high levels of patient satisfaction and minimal investment. We believe STAAR's investments in clinical evidence, consumer awareness, and customer partnerships in the U. S. will continue the elevation of EVO to a premium and primary refractive vision correction solution for a wide range of patients as it has successfully demonstrated in leading refractive markets globally. With the approval of our EVO family of myopia lenses in the U. S. , an estimated 100 million U. S. adults, ages 21 to 45 with myopia, in the range of minus 3 diopters and minus 20 diopters, are now potential candidates for EVO.

A few highlights from the initial few weeks of our U EVO commercial launch include EVO surgeon training and certification has already been completed for more than 100 doctors New practice support tools are in the hands of certified surgeons and their staff. New and exciting patient consult tools and brochures have been distributed. And a new EVO website in the U. S. was launched on April 18th.

The initial stages of a growing multi-city, multi-channel digital advertising and public relations campaign are underway with the goal of increasing EVO awareness and driving consumer desirability. The campaign will include Evo Display, search engine marketing, Instagram, YouTube, Facebook, TikTok, Snapchat, connected streaming TV, and audio podcasts. In the near future, our first U. S. celebrity Evo brand ambassador will be implanted with Evo lenses. The STAAR team globally is focused on making fiscal 2022 another year of record commercial and financial progress. We are particularly proud that we are continuing to achieve high levels of sales growth while also growing our company in a responsible manner with profitability and as a good corporate citizen. We recently issued our third annual sustainability report in April.

The report highlights our commitments to a culture of quality, employee well-being, diversity and inclusion, our growing philanthropy and community service efforts and partnerships, and our efforts to reduce our impact on the environment. The case for STAAR and EVO as the first choice refractive vision correction by our surgeon customers, consumer patients, and investors is indeed growing stronger. Patrick?

Thank you, Karen, and good afternoon, everyone. Total net sales for Q1 2022 were $63.2 million, up 25% as compared to the $50.8 million of net sales in Q1 2021, and up 7% on a sequential basis from Q4 2021. The year-over-year increase in net sales was primarily attributable to a 26% increase in ICL sales. ICL sales represented 92% of total company net sales for the first quarter of 2022, similar to the year-ago quarter in which ICL sales represented 92% of total company net sales. We continue to expect other product sales will be approximately 5% of total company net sales for fiscal 2022. As Karen mentioned, our outlook for fiscal 2022 net sales remains unchanged at approximately $295 million.

We expect net sales for Q2 to be approximately $80 million. Gross profit for Q1 2022 was $49.3 million, or 77.9% of net sales, as compared to gross profit of $39.1 million, or 77.1% of net sales for Q1 2021, The 80 basis point increase in gross margin as compared to Q1 2021 is primarily due to geographic and product mix and decreased period costs associated with manufacturing projects. The 160 basis points sequential increase in gross margin from the fourth quarter is due to the higher ICL sales mix in Q1 2022, geographic mix of sales, and a decrease in period costs of manufacturing projects.

For fiscal year 2022, we continue to expect gross margin to be approximately 77% of net sales. Moving down the income statement, total operating expenses for Q1 2022 were $37.2 million, as compared to $31.7 million in Q1 2021 and $37.6 million for Q4 2021. Operating expenses for Q1-22 were approximately $3.3 million lower than planned, primarily due to a shift in marketing expenses to Q2, Q3, and Q4 related to the timing of our U. S. EVO approval. Taking a closer look at the components of operating expenses, G&A expense for Q1 2022 was $11.9 million compared to $10.2 million for Q1 2021 and $11.5 million for Q4 2021. The year-over-year increase in G&A is due to increased facilities costs and compensation-related expenses.

The sequential increase from Q4 2021 was due to increased facility costs to allow expansion and scalability of our manufacturing operations to support sales growth. We continue to expect the G&A expense to be approximately $13 million to $14 million per quarter for the balance of fiscal 2022. Selling and marketing expense was $17.3 million for Q1 2022 compared to $13.2 million for Q1 2021 and $17.1 million for Q4 2021. The increase in sales and marketing expense from the prior year was due to increased advertising and promotional expenses and compensation-related expenses. We now expect selling and marketing expenses as a percent of sales to represent approximately 32% to 34% per quarter for the balance of fiscal 2022 and to be at the higher end of this range in Q2 and Q3 to support sales during our busiest quarters and reflecting the timing of U. S. marketing investments following FDA approval of our EVO lenses in the U. S. Research and development expense was $7.9 million in Q1 2022 compared to $8.3 million for Q1 2021 and $9.1 million for Q4 2021.

The year-over-year decrease in R&D is due to lower U. S. EVO clinical trial expenses, which were partially offset by an increase in compensation-related expenses. The sequential decrease in R&D is primarily due to lower compensation-related expenses. We now expect R&D expense, based on the timing of investments, to be approximately $11 million per quarter for the balance of fiscal 2022. Operating income in Q1 2022 is $12.1 million and 19.1% of net sales, as compared to $7.5 million or 14.7% of net sales for Q1 2021. Approximately half of the $4.6 million increase in Q1 2022 operating income is due to the timing of U. S. EVO marking investments that will now occur in Q2 and Q3 due to FDA approval occurring at the end of the first quarter on March 25th.

For fiscal year 2022, we continue to expect operating margin will be similar to the 14.5% of fiscal 2021, as anticipated leverage on G&A and R&D expenses is offset by higher sales and marketing investments targeted at building EBOL awareness and market share globally. Net income in Q1 2022 was $9.6 million, or $0.19 per diluted share, compared to net income of $5 million, or $0.10 per share in Q1 2021. On a non-GAAP basis, adjusted in income for Q1 2022 was $14.4 million, or $0.29 per diluted share, compared to adjusted in an income of $9.6 million, or $0.20 per diluted share in Q1 2021. For fiscal 2022, subject to no significant change in our valuation allowance, we now anticipate our quarterly tax rate for Q2 through Q4 will be approximately 25%.

A table reconciling the GAAP information to the non-GAAP information is included in today's financial release. Turning now to our balance sheet, our cash and cash equivalents as of April 1, 2022, totaled $193.1 million, as compared to $199.7 million at the end of the fourth quarter, 2021. The decrease in overall cash is due to the timing of annual compensation payouts that occurred in the first quarter. We still anticipate generating positive cash from operations for the balance of fiscal 2022 and ending fiscal 2022 with a higher cash balance than fiscal 2021.

Finally, STAAR will be participating in the William Blair Annual Growth Conference in Chicago on June 7th, the Jefferies Healthcare Conference in New York on June 9th, and the Sidonian Company Virtual Investor Conference on June 15th. We look forward to speaking with many of you at these events. This concludes our prepared remarks. Operator, we are now ready to take questions.

So, first of all, the contribution in the first quarter from EVO was negative. I mean, there was nothing in that quarter. It was Vizian ICL, but there was a nice ramp up in Vizian ICL in that a number of surgeons were getting ready, hopefully, for an EVO approval, which we were happy to receive by the end of the quarter. In terms of ramping up into the year, you know, our goal is to exceed our global growth level easily in the U. S. market. We aren't going to talk about exactly what that growth is, but obviously it's going to be high growth. In terms of the training of our surgeons, we expect to have 200 trained by June and 600 trained minimally by the end of the year.

In terms of ASPs, we're not going to be providing the ASPs we see in the U. S. at this point, but the pricing plan in the U. S. is the same as it is globally. When you have a strategic alliance agreement you commit to a certain number of lenses You have price and marketing assistance practice development and other aspects of the agreement that all play into the overall cost per lens per patient So that pretty much how we see the year which is going to be pretty darn successful Yeah, great.

Sure, Bill. Thanks for the question. We did not call out backlog, and as we've said now, we hope not to be able to call out backlog again, and we kept to that promise. We are continuing to work through it. Demand is very strong, as Karen has outlined, and so we do plan to work through that by the end of the second quarter is the goal right now, but things are very much on track from a capacity standpoint, and we're very pleased where we're headed in Q2 and beyond.

Okay, so we talked about specific distributor sales. Those were strong the entire quarter. Those are outside China. China is considered a hybrid market. In terms of China, we were very strong until the last week of the quarter in terms of our run rate to the surgence from our warehouses in China. Our expectation now, as I mentioned in my prepared remarks, is that there will continue to be opportunities to prepare for a very strong Q2 and Q3 in China associated with ramping up to be prepared for what we believe will be very strong demand from patients for surgeons to do procedures in multiple cities throughout China. So our confidence level is really built on the fact that we have such strong representation in China, both from our sales organization as well as from our prime distributor in China who has been doing a masterful job managing distribution entry points that match the opportunities by cities where surgeons are very, very active.

We are also preparing, as I said earlier, for the real busy season that really starts June and goes through July, August. This year we believe it will go all the way in through September. To be sure, we're very well prepared. So we have for a long time been selling out of our distribution warehouses to our surgeons to match the inventory available. So our opportunity now to rebuild is very, very welcome based on what we think will be very strong demand come especially in the June timeframe.

Thanks, Zach. Thanks, Zach.

If anything, we see Shanghai opening up, and that is the primary location where we normally fly in our inventory. There are multiple opportunities within Shanghai, Shenzhou, and a number of other major cities where we are able to ship and have distribution within China effectively. So our distributor has multiple sites for reception. In fact, this morning it was really fun to hear that one of his newest sites is right next to one of our biggest hospitals. So you have to be very fluid and have really, really strong presence in China on the ground to know what you're doing. If you're just basically managing China without being very, very effective in terms of understanding the protocol, what's going on, in terms of getting good input about even at the airports, what they're going to expect, when they're going to be able to receive, and on and on.

I mean, that's what for us is critical, and we manage it exceptionally well from our facility in Switzerland. So at the end of the day here, the dynamics in China for us are very strong. We really believe that though you'll see multiple markets open up, which they're already beginning to do, we know that the Chinese team and our surgeons in China, our partners, always work incredibly hard to make up what time they've lost. And so whether it's 12 hour days for seven days, that's what they'll do. So we're going to make sure we've got inventory available and that it's in the right place at the right time.

Sure. Thank you, Ryan. We believe the U. S. market probably has some of the most, I would say, sophisticated high-end consumers in the world. We know that there are many in China. At the end of the day, refractive surgery is not inexpensive. However, there is no doubt that the mathematics associated with the decision to purchase are very much in favor of refractive surgery. I will now turn the call back to surgery in terms of a single initial one-time payment and then not having repetitive contact lenses, contact lens solutions, repetitive doctor visits, as well as glasses necessary any longer. When you take basically our customer base in the United States, they tend to be well-educated. They tend to have high disposable income.

They're individuals who really value an active outdoor life. More women than men, actually, at least at our last look, between 21 and 35 years old. Their choices in their lives on health and happiness, frankly, tend to be some of the greatest in the world. So our expectation in the U. S. is that we will be very successful by following a lot of the protocol and a lot of the plans that we've done around the world. And you heard in my prepared remarks the amount of social media outreach there will be and will include some very exciting influencers. So our belief in the U. S. is that inflation, unless it becomes extreme at all levels, should not impact us much at all.

Okay. You do that.

Sure. If I may, just thinking back to just two weekends ago at Asterisk, there was clearly a very palpable buzz about Evo here in the United States, and you all, I'm not going to join TikTok with Ryan. I'll let him do that. But just looking at social media, you know, it's a prolific presence there as well. Could you just speak to, as you're kind of building the pipeline, a little bit more color about the surgeon base that you're bringing on board? 200 to be trained here by June. These are unique practices, at least perceived that at least early on. I just want to get a little bit more color on how you pick these practices and maybe why they're more resilient for you in terms of building a practice going forward, especially in this inflationary type environment.

I've got a quick follow-up. Sure, Chris. So, when we determined the order and timing of training surgeons, it was really all about those surgeons who either had already successfully been busy in ICL surgeons and very comfortable in the eye, KOLs who were very excited about visiting ICL but really wanted to get rid of the peripheral iridotomy, as was evidenced at our special We will now turn the call over to the STAAR SURGICAL CO, which is a Friday night educational event. And then also those surgeons who are interested in transforming their menu of services and offerings to patients to more lens-based care. And so when we put that all together, it was easy for us to determine where we needed to go first.

And then we also wanted to make sure we had great representation in every major refractive market in the United States, We going to do a multimedia campaign in each of those markets effectively between now especially in the end of the year when they starting up So that story about 50 demand out of full demand for refractive procedures being EVO in a major market that exactly what we wanted to hear And so at ASCRS, and thank you for bringing it up, it was an amazing show for us. And, you know, we loved actually having a starring role, to be blunt and honest. And I think what we believe is that this training progression goes quite smoothly for those who already have successfully implanted Vizian in the eye.

We can do some virtual certifications, and then the ones that need to be in person, we have a phenomenal team of trainers who will be working with them so that we can achieve the numbers that I referenced earlier in terms of fully trained surgeons ready to go.

So in terms of the myope and what the surgeon will offer in terms of minus three and above and kind of where they're going to be part, I think it's going to be a surgeon by surgeon determination of where they'll start, but I'm very encouraged in that the number of surgeons we talked to, many of them said they were going to offer it to all patients, which is what we found, especially when we talked to the patient. Especially in other major markets around the world is, surgeons might start off around maybe minus 7 to minus 10. But then as they get this phenomenal feedback of patient satisfaction and, you know, incredible compliment in terms of the ability to have a patient satisfied almost from the first minutes after the procedure, they start to offer to everyone for all those benefits we talked about earlier and we'll continue to talk about.

I think with Hyperopic, we'll table that for another day in terms of how we'll manage that market. But at this point in time, I think we've got a great opportunity, really minus three, minus seven in the United States in a bigger way than we could have imagined.

Thanks, Chris.

Sure. So what we decided to do is to triple capacity. And ideally, as we talked about, we're looking at 20% plus market share in the major markets around the world. We want to get higher than that, if even possible. So what our plan does is allows us to sell millions of lenses a year instead of hundreds of thousands of lenses a year. So, you know, we're nearing over 2 million lenses sold ICLs. We've got a million and a half lenses sold EVOs. And with this growth rate, bottom line is we can see ourselves selling millions of lenses in the not-too-distant future on an annual basis. So that's what we're building. That's what we're seeing our capacity to handle.

Sure. Yeah, so we haven't broken out, you know, what percentage is going to the U. S. What I can tell you, though, that this is clearly an investment here of building brand awareness in conjunction with U. S. Evo approval, but as we've always said, and as Karen said earlier, you know, the U. S. market is a very strong market, but it also can be a global influencer across it. So we look at this as really building global brand awareness. But we haven't broken it out, but as I said, the increase is primarily involved with general brand awareness for EVO in the U. S. You had one more question there, I think you had at the end there, Andrew.

Andrew S. Yeah, so things have changed quite a bit. I think we're still deciding what's appropriate for us to talk about. We track a lot of things internally, but certainly with The influencers and the ability to track those much more accurately than what you could have done five, ten years ago with some of the traditional marketing programs out there. We feel very good about being able to track dollars invested to what it ends up being, which is what we ultimately want, which is a conversion, someone getting implanted. But we'll hold off on that, and as we get more information, we'll look at what we want to share.

Thanks. Thanks.

Well, there are a number of prognosticators within refractive surgery about how big a piece of the action star will begin to conquer. I can tell you right now that based on the enthusiasm and the fact that every new surgeon is posting on Instagram and YouTube and other places themselves and their surgeon satisfied and excited, I think that some of those higher numbers of percentage of opportunity for STAAR are probably in play. We have a number of practices that are signing agreements. We have a number of practices that are asking for support with practice development, with marketing. And when we put all that together, some surgeons of renown think we'll be at 30% sooner than we ever expected.

So I think it really is going to depend on our ability to meet a very strong demand and make sure that we manage this rollout, which I believe the team is doing a phenomenal job. I thank them very, very much. We have a really great sales and marketing organization distribution operations in the U. S. , and I'm very pleased with their progress. So long answer, but, you know, we could talk about this all day. We're that excited. We just really think we're going to do phenomenally well here in the U. S. , better than expected.

So with regard to surge and uptake and who's making these estimates of where we'll be, I mean, it's all over the board, but there have been some major society meetings where some surgeons have stood up and said, I really see STAAR and a lens-based future taking, you know, over 50% share. Then there are others that think there will be a split between SMILE, laser vision correction, other, LASIK vision correction, and STAAR. But anyway, you look at it, for us, this is a tremendous opportunity to make sure that a lens-based feature happens with the best possible lens on the planet, which is us.

Patrick. Yeah, thanks, Davis, Patrick. So on the free cash flow, you know, the quarter we did have negative operating cash, and I talked about that. That's really had to do with annual compensation timing, and then also some timing of just some AR related to us, primarily some big customers towards the end of the quarter. So we're in very good shape. We'll have positive op cash flow. We still plan to spend upwards of $20 million on CapEx. We did almost $2.5 million in Q1, and so that's all part of the capacity that we've talked about.

I would expect free cash flow will be pretty close to positive. It really depends on how the balance of the year goes, and then we'll come back if anything changes. But we're getting a good spot from a cash standpoint.

Thank you so much for your participation on our call today. We look forward to speaking with many of you in the days and weeks ahead. We appreciate your interest and investment in STAAR SURGICAL. Please take good care and all the best to all of you.