STAAR Surgical Company

Hello all and thank you for standing by. Welcome to the Star Surgical second 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 star followed by the number one on your touchtone phone. If you're using speaker equipment today, please lift the handset before making your selection. This call is being recorded today, Wednesday, August 10th, 2022. At this time, I'd like to turn the conference over to Mr. Brian Moore, Vice President, Investor Media Relations and Corporate Development for Star Surgical. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Thank you for joining us on the Star Surgical conference call this afternoon to discuss the company's financial results for the second quarter ended July 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 second quarter results was issued just after 4 p.m. Eastern Time and is now available on STAR'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 risk and uncertainties associated with the forward-looking statements made in this conference call and webcast are described in the Safe Harbor Statement in today's press release, as well as STARS public periodic filings with the SEC. Except as required by law, STARS seems 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 limit themselves to two initial questions, then recue 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 STAR.

Thank you, Brian. Good afternoon, everyone, and thank you for joining us on today's call. The second quarter results we reported today represent a record level of quarterly sales per star at $81.1 million, which represents 30% year-over-year sales growth and considerable progress in advancing our EVO-ICL family of lenses. Considerable progress in the quarter includes a fantastic start in introducing our game-changing EVO lenses to the US market, the second largest market for refractive vision correction. We could not be more thrilled to announce today, in a separate press release, our partnership with musician Joe Jonas, who will drive awareness of EVO and the visual freedom possible with our lenses among the millions who suffer from myopia globally. I will touch on the partnership more shortly. For the second quarter, we achieved record results despite COVID-19-related challenges and foreign currency headwinds. We also held fast to our culture of quality and manufacturing excellence in generating the second quarter results. Last month, on July 15th, we received our official five-year MDR certification from our European Notified Body, DECRA. As many of you know, MDR certification is a change to the regulatory framework, and recent data suggests fewer than 25% of medical device companies have received MDR certification. My thanks to the STAR teams involved in this milestone accomplishment, and particularly the regulatory and quality teams, which further demonstrates our commitment to STAR's culture of quality imperative. For the second quarter of 2022, global ICL unit growth was up 42% year over year, despite some ongoing softness in Europe, which we attribute to macroeconomic factors. By geography, we achieved strong ICL unit growth. In China, up 45%. The United States, up 36%. Japan, up 41%. India, up 181%. And Asia-Pacific distributor markets, up 66%. all as compared to the prior year quarter. In China, the peak summer implant season for EVO procedures is well underway. As we talked about on our last call, China began implementing COVID-19 related lockdowns in multiple cities associated with the zero tolerance policy at the end of March. While refractive surgeries were temporarily halted, in various provider locations in China. In other parts of China, refractive surgeries continued. SARS China team and our customers have been extremely agile in responding to the lockdowns. In some hospitals and clinics, our surgeon customers continue to perform refractive surgeries seven days per week. Lockdowns in China are also currently below the peak levels we saw during the second quarter. We expect to successfully navigate the current COVID-19 related challenges and meet anticipated levels of future demand. In the U.S., the commercial introduction of our Evo family of myopia lenses is off to a strong start. Each day seemingly represents a new and exciting moment or milestones for STAR and Evo in the US, including the announcement of our partnership today with singer, songwriter, and actor Joe Jonas. With tens of millions of followers on social media, Joe Jonas is now our most recognizable Evo ambassador globally. Importantly, Joe Jonas is an actual Evo patient and not simply a spokesperson. This is the case for all of our EVO ambassadors. Joe needed EVO lenses below minus five diopters, which once again illustrates that EVO lenses are suitable as a vision correction solution for a wide range of patients in myopia, low, mid, and high. Joe Jonas was a great candidate for EVO and is thrilled to have his EVOs. Beginning next month, he will begin sharing more details of his visual freedom with Evo via a global advertising, marketing, and social media campaign. We are inspired by Joe's personal story and appreciate his willingness to share his Evo journey with millions of others who could also benefit from living a life with visual freedom. Enthusiasm and adoption of Evo by US refractive surgeons is also growing. Many of our surgeon customers and their staff are actively on social media, LinkedIn, and in local market media providing positive EVO testimonies. We remain on track to train and certify at least 600 US surgeons on EVO by the end of this year, with already more than 400 surgeons trained and certified today. Existing and potential U.S. surgeon customers tell us they are excited about the EVO surgeon experience when they speak to their peers outside the U.S., when they consider the EVO opportunity here, and when they review EVO safety and efficacy data from our U.S. clinical trial. In addition to the paper available on STARS Investor website, published by our medical monitor, Dr. Mark Packer, discussing the US EVO clinical trial. Data from our US clinical trial has also now been updated on clinicaltrials.gov. We invite investors and analysts to review key findings from the 629 eyes of 327 subjects implanted with EVO lenses in the trial. Next month in September, We will showcase our entire evil family of lenses at our experts meeting and the 40th Annual Congress of the European Society of Cataract and Refractive Surgeons in Milan, Italy. We will feature VIVA, our innovative lens for presbyopia, at both our experts meeting and ESCRS. We will also begin commercialization of VIVA to certified surgeons where approved which is CE mark countries and geographies recognizing the CE mark. Looking ahead to future surgeon customer engagement, we plan to host our second US Surgeons Council meeting in San Antonio, Texas in November. Looking at full year fiscal 2022, in today's earnings release, we reaffirmed our previously provided outlook for fiscal 2022 net sales of approximately $295 million, which takes into account the significant currency headwinds and a continuation of the current level of COVID-19 related challenges in China and elsewhere, offset by stronger than expected global demand for our EVO lenses, which continued through the beginning of the third quarter. Organizational energy and enthusiasm at STAR is especially exciting. In addition to the surgeon engagement and other activities I just shared, we have a planned lineup of additional Evo Ambassador influencers in the US, including an NBA player and a Gen Z actress, model, and style icon. We are also introducing new ambassadors and campaigns outside the US including Japan and South Korea. Like Joe Jonas, all of our EVO ambassadors have had or will soon have the EVO procedure. Our EVO ambassadors will begin sharing their journeys in the coming months. It took over 22 years for STAR to sell the first one million ICLs and just about three years to sell the second one million lenses. a milestone we achieved in June of 2022. Now and in the future, Star aims to be the visual freedom company. For those who want to experience an active and fulfilling life free from contact lenses and glasses, the choice is evil. Patrick?

Thank you, Karen, and good afternoon, everyone. Total net sales for Q2 2022 were $81.1 million, up 30%, as compared to $62.4 million of net sales in Q2 2021, and up 28% on a sequential basis from Q1 2022. The year-over-year increase in net sales is attributable to a 32% increase in ICL sales. For Q2 2022, ICL sales represented 96% of total company net sales, similar to the year-ago quarter in which ICL sales represented 95% of total company net sales. We continue to expect other product sales will be approximately 5% of total company net sales for fiscal 2022. QQ 2022 reported net sales includes an approximate $3.1 million negative impact year-over-year from changes in currency, primarily to Japanese yen as well as the euro. In constant currency, net sales for Q2 2022 would have been $84.2 million, up over 35% year-over-year. Please refer to the constant currency table in today's earnings release for additional details. For analyst modeling purposes, due to currency headwinds, we expect Q3 net sales to be approximately $74 million to $75 million. our outlook for fiscal 2022 global ICL unit growth remains robust and is actually higher than our outlook entering the year. Therefore, even in the face of significant currency headwinds, we are today able to reaffirm our previously provided outlook for fiscal 2022 net sales of approximately $295 million. Turning back to Q2, gross profit for Q2 2022 was $63.9 million, worth 78.8% of net sales, as compared to gross profit of $49.2 million, or 78.9% of net sales for Q2 2021, and $49.3 million, or 77.9% of net sales for Q1 2022. The 90 basis points sequential increase in gross margins from Q1 2022 is primarily due to favorable geographic and product mix and manufacturing efficiencies, partially offset by increased inventory reserves due to the discontinuance of our older generation Visi and ICL in the U.S. and increased period costs associated with manufacturing projects. For fiscal year 2022, we now expect Q3 and Q4 gross margin to be approximately 79% of net sales. Moving down the income statement, total operating expenses for Q2 2022 were $46.9 million as compared to $38.6 million in Q2 2021. and $37.2 million for Q1 2022. Taking a closer look at the components of operating expenses, G&A expense for Q2 2022 was $14 million compared to $11.4 million for Q2 2021 and $11.9 million for Q1 2022. The year-over-year increase in G&A is due to increased facility costs and compensation-related expenses. The sequential increase from Q1 2022 was due to increased compensation-related expenses. We now expect G&A expense to be approximately $15 million for both Q3 and Q4 2022. Selling and marketing expense was $24.2 million for Q2 2022 compared to $18.9 million for Q2 2021 and $17.3 million for Q1 2022. The increase in selling and marketing expense from the prior year was due to increased marketing, promotion, and advertising expenses, trade show expenses, partially offset by decreased compensation related expenses. The sequential increase in selling and marketing expense from Q1 2022 is due to increased marketing, promotion, and advertising expenses, and trade show expenses, as well as compensation related expenses. We now expect selling and marketing expenses as a percent of sales to be approximately 35% for both Q3 and Q4 2022, reflecting the timing of the exciting new marketing investments globally that Karen just discussed. Research and development expense was $8.6 million in Q2 2022 compared to $8.3 million for Q2 2021 and $7.9 million for Q1 2022. The year-over-year increase in R&D is due to increased compensation-related expenses partially offset by lower clinical trial expenses. The sequential increase in R&D from Q1 2022 is primarily due to compensation-related expenses. We now expect R&D expense to be approximately $10 million for Q3, ramping to $11 million for Q4 due to the timing of investments. Operating income in Q2 2022 was $17 million, or 21% of net sales, as compared to $10.6 million or 17.1% of net sales for Q2 2021. We now expect operating margins for fiscal year 2022 to be approximately 15% due to higher than anticipated gross margin and lower than anticipated operating expenses. For Q2 2022, net income was $13 million or 26 cents per diluted share compared to net income of $8.6 million or 17 cents per diluted share for Q2 2021. On a non-GAAP basis, adjusted net income for Q2 2022 was $20.7 million, or 42 cents per diluted share, compared to adjusted net income of $13.6 million, or 27 cents per diluted share for Q2 2021. A table reconciling the GAAP information to the non-GAAP information is included in today's financial release. Also for analyst modeling purposes, Please note that we continue to expect our quarterly tax rate will be approximately 25% for Q3 and Q4 2022, subject to no significant change in our valuation allowance. Turning now to our balance sheet, our cash and cash equivalents total $202.5 million as of July 1st, 2022, as compared to $193.1 million at the end of Q1 2022. In Q2 2022, we generated $13.2 million in cash from operations and invested $5.3 million in property and equipment. We continue to expect CapEx for the full year fiscal 2022 will be approximately $20 million. We also continue to anticipate generating positive cash from operations for the balance of fiscal 2022 and ending the year with a higher cash balance than fiscal 2021. Finally, SCAR will be participating in several investor conferences and events in the coming weeks, including the Needham Virtual MedTech and Diagnostics Conference on August 16th, the Piper Sandler West Coast Field Trip on August 23rd in Dana Point, California, and the William Blair West Coast Field Trip in San Diego, California on August 30th. 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.

Thank you. If you'd like to ask a question, please press start followed by the number one on your telephone keypad now. To withdraw your question, please press start followed by two. And when preparing to speak, please ensure your device is unmuted locally. Our first question today comes from Andrew Brackman of William Blair. Your line is open. Please go ahead.

Hi guys, good afternoon and thanks for taking the questions. I guess I really want to ask you what your favorite Jonas Brothers songs are, but I won't go there on this call. In all seriousness, Aaron, maybe on this influencer platform, obviously this has been a big part of the playbook internationally before. As you think about this coming to the United States and helping with the U.S. launch, what can you sort of tell us about sort of what you've seen in sort of terms of sales trajectory and past experiences when you have announced a big partnership like this? And then separate from historical sort of experiences, anything that you're expecting from this partnership in particular moving forward? Thanks.

Hey, Andrew. Thank you for joining us today. So when we launched, with a major influencer, the focus is really on getting the message out that there is an implantable polymer lens called Evo. And the focus is to get individuals who are very interested in the lives of those influencers, especially those who are also challenged with glasses and contact lenses, to immediately learn more. And so what we do with the information that we have, like we've done today, is on evoicl.com, if you were to go there today, Joe is on our front page of our consumer-facing website talking to you personally about his journey. And what tends to happen is we get, as you can imagine, a very nice bump in interest, a huge increase in doc finders, and a very nice transformation and transition rate to actually having the surgery done. So our expectation is that in the U.S., as Joe's campaign rolls out over the next especially six weeks, culminating on September 12th, or September 7th, with a full media day in New York City and a number of appearances on national television, As well, followed up by Joe publishing and posting on Instagram, TikTok, Twitter, and others, where he has over 30 million followers combined, you're going to see a lot of immediate interest. Also, we're expecting Joe, who has been interviewed today by People Magazine, to be featured on their online event. uh, website and, um, there, I think they have approximately 77 million unique visitors a month on people magazine online, um, actually make that daily. Um, and then people magazines, Instagram with 11 million. So, um, on this particular influencer, we love Joe. We think Joe's terrific and we believe Joe's story is real. and important. And so our expectation is there will be a lot of interest, more than we've experienced anywhere else around the world.

Thank you. There's some big numbers in there for visitors and sort of unique hits. And then maybe I guess I could ask a question around China. So obviously another strong quarter of performance there. But I guess as we're thinking longer term here and as you sort of continue to move up the ladder on market share in that region, Can you just sort of talk to us about how maybe some of the drivers of that share might change over the next several years? Is it still going to be predicated on sort of growing the share in the large clinics that are already using EVO, or does it shift a little bit more to getting into smaller clinics or different geographies within the country? Thanks.

Well, we're going to continue on the successful path that has gotten us where we are. and that means that we're going to continue with our strategic alliance partners, many of whom are very large, the largest being Ayer, to work very successfully with them as they grow and to make sure that their business model shifts toward lens-based, namely EVO, continues aggressively. So we just participated actively in the 20th anniversary celebration of Ayer, and we continue to be impressed with their growth and their commitment to especially the refractive space. But we have actually grown our base in China to now over 1,000 hospitals and clinics. We continue to move in all directions in China, wherever there is opportunity. We're increasing our distribution centers to make absolutely sure that we are able to get to any surgeon anywhere in the country when needed. And so our commitment in China continues to be very strong. And we expect, by the way, the U.S. to give them a run for their money.

That's great. Thanks so much.

You're welcome. Thank you.

Our next question today comes from Bill Plovenick of Canaccord Genuity. Bill, your line is open.

Great, thank you, and thanks for taking my questions. First of all, I'll just start with the U.S. You know, one, you know, that number was up nicely, and just kind of trying to understand, you know, how should we think about the U.S. for 2022? Was there any swap-outs or destocking in the second quarter that may have impacted the numbers? And then my second question is on... backlog that from a manufacturing standpoint, I don't think there's any commentary on that, but where are you in kind of burning off that 20 million lens backlog that you had at the beginning of the year, you know, and how should we think about that impacting the back half? Thanks. Hey Bill, it's Patrick.

Yeah, the U.S. was phenomenal. And so when we got the approval in late March and we ended up launching What we did see were doctors wanting to switch over to Evo almost right away. And so, as Karen mentioned, we're very much on track, in fact, ahead of where we wanted to be in terms of training of docs with over 600 now. So we did talk about that in our financials, but we did take a reserve on our old Vizion product in the U.S., and that speaks to just how quickly the adoption has happened in the U.S. Your second question, I'm sorry, was on, oh, backwards, yeah. So on the backlog, look, we're not going to get into the details on it. I think what we proved in Q2 is our ability to deliver a substantial number of lenses worldwide, and we're very happy about that, and we continue to work through satisfying all our customer needs, especially on the custom lenses that take a little bit longer for us to produce, but we're in very good shape there and continue to bolster that up through our operational team as we move through the rest of the year.

Yeah, Patrick, the question on the U.S. was, was there a negative hit to revenues when you took the reserve, or is that just an impact to the COG line or somewhere else or SG&A line? And then on the backlog, I mean, it's kind of important for us to understand is have you burned that off and refilled that, or is it still sitting there? Because if you kind of stocked in versus kind of and just got rid of the old orders, or you still have some of it sitting there. So thanks for taking my questions.

Yeah, so the cost of goods, it's a cost of goods reserve that we took, so no impact on revenue. On backlog, once again, I would just say that we have worked through some of that backlog. There's still a little bit to go, but, you know, we've accounted for that in our full-year guidance, and so I'll just leave it at that. Thank you.

Our next question today comes from Chris Cooley of Stevens, Inc. Please go ahead.

Good afternoon, and thanks for taking the questions, and congrats on another record quarter. Karen, if you wouldn't mind, could you just give us some additional color on these kind of early days experience in the U.S. launch? And in particular, I'm interested in learning a little bit more about what you're seeing just from a prescribing pattern in terms of like the diopter. the mix that you're seeing in some of these practices, say, now a couple months out in terms of the ICL versus LASIK and SMILE. And just, I think on the last call, you gave us an anecdotal commentary about one practice that had already moved to 50%. So just would appreciate some additional color on kind of how you're seeing this utilized in these early adopter practices. And then I've got a follow-up.

Sure. Thank you, Chris. Well, the early adopters are really interested in offering EVO to a wide selection of patients. We believe that very quickly the message has gone out based on outstanding results of our clinical study that not only showed great safety, but the effectiveness at the lower diopters and how great this lens performs in the NEI in the target range of minus 3 to minus 20. We're seeing a number of surgeons having their own family members have procedures. And I think the greatest testimony is that we're signing the largest strategic alliance deals we've done in terms of committed volume annually that we've ever seen here by a wide margin. And so certain surgeons who early in the game said that once EVO was approved, they would change the mix of their offering, they're now coming to the table to sign deals to prove it. On top of that, every single day we get multiple indicators through the surgeon's own work by them posting online, on social media, all their enthusiasm about the Evo product, talking about its advantages as they see it over the other procedures that they offer. And so when you think that we've only been out there for a couple of months, now we believe with the number of surgeons who are trained over 400, actually it's 461 as of today. We'll have 600 very soon and more beyond that. We believe that with our influencer campaign, with all the local marketing we're doing with the surgeons, as well as the more excited influencers who aren't maybe a household name, but we just signed a really exciting chef who's very, very popular and has multiple channels on the internet. So I think we can just put it all together. I believe that we will exceed the growth rate we had in China when we first started to really push

in 2016 and 17. that's super really appreciate all the color and then maybe just an operational question for patrick you know the company's been scaling up tripling capacity just would appreciate if you could give us maybe a little bit of an update on where you are in the process and then maybe more importantly how should we think about this as it relates to gross margin i mean obviously you're you know upper or top tier when we think about the gross margin profile today but As that capacity comes online and it's absorbed, how should we think about this step up in product gross margin longer term? Thank you, and again, congrats on the quarter.

Thank you. Sure, Chris. Yeah, so in terms of where we're at, things are just going outstanding. You know, the operational team has really stepped up, as we saw, by delivering such a huge 2-2 for us, and especially on a sequential basis. We're well positioned for the rest of the year. And we will continue to add capacity, not only in the U.S., but as we move out into our Switzerland facility as well into 2023. In terms of that impact on gross margin, try to account for it in the guidance. I think in any given quarter, as we bring on new facilities and you get that fixed cost, we'll do our best to guide you all from your modeling standpoint. But as I said, approximately 79% in Q3 and Q4, and we're very comfortable with that. So, you know, other than that, I think we're in good shape when it comes from all that stuff.

Thank you.

The next question today comes from Zach Wiener of Jefferies. Please go ahead.

Hey, thanks for taking the question and congrats on another great quarter. I just want to touch on China procedural volumes and fully appreciate the color provided in the press release. But if you could give some color on unit growth, sorry, on procedural trends in China through this new COVID policy that they have. And if there's any call, like a local backlog in China that you guys are seeing.

Actually this year, because of the intense effort to be able to really manufacture aggressively to support what we knew would be very increased demand for this busy season, which has turned out to be the case. We actually have the best inventory position we've had historically in China. And we are using it all. So the bottom line is we're having a really strong busy season through today in the third quarter. Our expectation is that we'll continue appropriately through the end of the busy season, which is about mid-September. And then we'll be in a replenishment mode for our more typical quarters that aren't quite as aggressive as Q2, which follows our annual So, I think bottom line here is that we're going to definitely need to replenish because we're using everything that we're sending.

Good. That's helpful. And then just one on the presbyopia ones, just any early feedback that you're hearing that you can share?

Well, we're still in the limited launch. We're really not going to formally launch. beyond the early surgeons until after about September 20th. The feedback we're getting now from the surgeons who are contributing to the playbook is that the Evo family of lenses with the Viva Edition is giving them a great armamentarium to treat their presbyopic patients as they learn from their myopia business what it takes to properly identify a presbyopic patient properly target for that patient, implant, and follow-up. It is a whole different game. It takes longer, but we believe we're going to have a heck of an entry in the market.

Got it. That's helpful. And then just one follow-up on the VivaLens, if I could. And any color on getting the VivaLens into other markets beyond the CE mark countries? Thanks for taking the questions.

Yes, our initial focus, of course, was CE mark countries and countries that recognize the CE mark, but we are getting closer to announcing other countries where we will be able also to distribute the lens. Thank you, Zach.

Our next question today comes from Ryan Zimmerman of BTIG. Please go ahead with your question.

Yeah, thanks. Good afternoon. Thanks for taking our questions. I want to start, Karen, if I could, around pricing and ASPs. First, I think just based on the proportion of sales into China, you saw a little bit lower ASP. One, is that correct? But how to think about modeling ASPs as the U.S. becomes a larger proportion of sales? And just what can you say in terms of your thoughts on it globally, given the you know, the larger effects and inflationary dynamics that, you know, we are seeing across the MedTech industry?

Well, I think I'll answer the back half of your question first. Had we not had the FX headwinds, we would be reporting $84.5 million of revenue. And so we're very pleased with that. Our ASPs are on track in our Asian markets. They do differ by each country, China being the most aggressive pricing for the highest volumes. In terms of our pricing in other Asian markets, we continue to be increasing our ASPs in spite of volume increase. And so premium and primary marketing garners that kind of commitment and that kind of price point. As we add more volume in the United States, where we do charge a different price schedule, we do go direct. And so as a result of that, we ought to see those ASPs going up. nicely over the next 24 to 36 months.

Okay, that's helpful, Karen. And just, Patrick, you know, given the FX impact this quarter, do you have an idea, or can you give us the FX that you're expecting for the full year, given the reaffirmed guidance, how much FX, you know, or I guess I should say underline, what is your underlying expectation for revenue given FX for the remainder of the year?

Yeah, no, appreciate the question, Ryan. And so, you know, we gave the original guidance of approximately 295 at the beginning of the year. On our constant currency table, you can see that we've now had about $5 million of FX headwinds for the first six months. Notably, $3 million plus was in Q2, which is when we really started seeing increased volatility with the strengthening of the dollars. So I really have to go back to what would be the impact in the second half of the year based on that initial guidance, which we've now been able to really keep steady in light of this headwind. So I think it would be fair to say there's probably at least additional $5 million of FX impact in the second half of the year. And so we've taken that into account in this guidance, and we'll have to see where the rates go from here. But we're feeling comfortable with where we're at. And that's why we try to focus everyone on units. It's just a phenomenal unit quarter with over 40% growth on the unit side. but we're still able to deliver the revenue.

Okay, appreciate that. And then, you know, lastly for me, just, you know, how to think about the U.S. trajectory, and I think this has been kind of asked already, but, you know, given where kind of street expectations were this first quarter of launch for Evo, I should say, you know, how do you see that growing, you know, you know, quarter over quarter through the remainder of the year. And if any color or, you know, kind of commentary you can give, guidance, I think would be appreciated by the street.

Well, we haven't really released what we thought the growth should be or will be. What we are doing is reporting really great growth. I think the bottom line is I wouldn't be uncomfortable saying we'll grow more in the third quarter than we did in the second quarter and so on. But at this point, we're just giving kind of the overall view of the business, the strength of the business, and our ability to manage multiple markets well. But our real focus in the United States now is real, it's tangible, and we have the highest hopes for some great demand. We're making sure that our surgeon partners are ready for what we hope will be an onslaught of interest. So, you know, at this point, we're not going to call a number, but we will say that the growth numbers ought to exceed where we've been.

Thanks for taking my question.

Thank you, Ryan. Our next question today comes from David Saxon of Needham & Company. Your line is open.

Oh, good afternoon. Thanks for taking the questions and congrats on the quarter. I guess, you know, a number that stood out to me in the script was the 400 docs trained. If memory serves, last quarter you only trained 100 docs. So just wondering, you know, if 300 is a good quarterly pace we should think about. And then, you know, looking at the 400 docs you have trained, maybe can you just talk about the refractive share ramp you're seeing for EVO in the weeks and months after that training?

Well, there isn't a statistic associated with the number of surgeons already traded, how that will play out over the coming quarters, other than what we know we can do by the end of the year. Um, so our goal is to be sure that we are certifying surgeons who have a dedicated commitment to increasing their profile of Evo managed patients. Um, and that in the agreements we have with them, um, that they meet the growth trajectory to commit to, and that they have really happy patients. And so with all of that, we're pacing ourselves to do this right. In terms of the number of additional surgeons who come on, our belief is that it's not going to be unlike any new medical device that catches on with the strongest surgeons in the market. Every other surgeon is going to be very interested in getting trained and getting smart and making sure that economically they benefit from what we believe is an incredibly excellent outcome for their patients. So my answer to you is that stay tuned. Our goal is to have thousands of refractive surgeons trained, but we are not committing to a volume other than the 600 or so through the end of this year as we have what you might call a longer timeframe to success with surgeons who are brand new to implanting lenses, maybe from and all laser vision practice. So I think the bottom line though is as is the case in a lot of procedures, you get a huge amount of your volume from a relatively small number of surgeons and then others catch on and before you know it, your market share does get up to that 15 and 20%. That's certainly what's happened in every other market where we have unraveled and rolled out these new ways to perform refractive surgery that really does garner excellent support from surgeons and a lot of patient satisfaction.

Okay, that's super helpful. And then maybe I'll ask another on the U.S. I mean, it sounds like you're expecting growth to accelerate from here on out. So maybe talk about the sales force you have in the U.S. Do you need to hire more or do you feel like the size of Salesforce is sufficient to support this U.S. launch? Thanks so much, and congrats again on the quarter.

Thank you very much, David. So we have a really strong contingent of account executives, practice development, clinical. We wrap around our surgeon customers a team of what we believe is excellence, We make sure we get them over the goal line. We make sure we monitor and work with them on their outreach to their local consumers, their web marketing, et cetera. It is a unique skill set. It is a very strong leadership requirement of which we have a very strong contingent of players. We will continue as need be to add on. But we also find that being in the unique situation we are today and hope to be in for a long period of time, our premium and primary position does not require us to have a sales organization playing defense. We're purely an offensive game, and we expect to stay that way for a relatively long period of time. So as a result of that, our sales and marketing expenditures will be more tilted toward digital marketing, social media, influencers. Those are going to be the way that we get EVO out so people are asking for EVO the way they know to ask for other important procedures like they have for years, laser vision correction.

Thank you. And our next question today comes from Steve Lichman of Oppenheimer & Co. Please go ahead.

Thank you. Hi, guys. Karen, you mentioned stronger than expected demand for EVO. And Patrick, I think you mentioned you have higher unit growth expectations now for the year versus when the year started. Is there a region or two that is standing out versus your original expectations Any you'd point out in particular that is driving upside versus your expectations heading into the year?

I would say that today Japan, Korea, China, Germany, and the U.S., and even India are performing better than expected.

Okay, got it. Okay. Patrick, nice to see a gross margin guide raised in this environment. Are you still feeling some headwinds from inflation in that number? How much if so, and what are you doing to offset it?

Yeah, so the nice thing about our operation is that we're fairly vertically integrated. So we do get raw materials in order to make our columnar But from there, we build obviously the lenses and go forward. We have seen related to COVID as everyone else has wage increases that's factored into our guidance. We have seen maybe a little bit on the raw materials, which is factored in. But I think generally the ability for us to raise our gross margin has everything to do with the efficiencies that we're seeing out of our outstanding operations team. We're very pleased with what they've been doing over the last couple quarters and pleased with what's going to come for the second half of the year.

Great. Thanks, Patrick. Thanks, Karen.

Thank you. Thanks. We have now reached our allotted time for questions, so I would now like to turn the call back to Karen Mason for closing remarks.

Thank you very much for your participation on our call today. We look forward to speaking with many of you the days and weeks ahead. We appreciate your interest and investment in Star Surgical. Take good care. All the best to all of you. Thank you.

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