00:04 Good day, ladies and gentlemen. Thank you for standing by. Welcome to STAAR Surgical First Quarter Financial Results Conference Call. During today’s presentation, all parties will be in listen-only mode. Following the presentation, the call will be open for questions. [Operator Instructions] This call is being recorded today, Wednesday, May 4, 2022. 00:35 At this time, I would like to turn the conference over to Mr. Brian Moore, Vice President, Investor, Media Relations and Corporate Development at STAAR Surgical. Please go ahead.

00:46 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. 01:00 On the call today are Caren Mason, President and Chief Executive Officer; and Patrick Williams, Chief Financial Officer. The press release of our first quarter results was issued just after 4:00 P.M. Eastern Time and is now available on STAAR's website at www.staar.com. 01:21 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. 01:42 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. 01:58 The risks 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 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. 02:25 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. 02:53 Following our prepared remarks, we will open the line to questions from publishing analysts. We ask analysts limit themselves to two initial questions, then re-queue with any follow-ups. We thank everyone in advance for their cooperation with this process. 03:11 And with that, I would now like to turn the call over to Caren Mason, President and CEO of STAAR.

03:19 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. 03:45 We’re particularly excited about the enthusiastic adoption by surgeons first to be trained in the U.S. following recent FDA approval of our EVO family of lenses for myopia. The first U.S. EVO patient implants occurred within days after approval. We enjoyed a strong commercial introduction of our EVO lenses less than two weeks ago at the largest industry trade show in the U.S., ASCRS. 04:18 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 tradeshow was palpable. The cage for EVO and STAAR is the first choice for refractive vision in correction by our surgeon customers, consumer patients, and investors continues to grow stronger. 04:47 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 market is up 43%, and Latin America up 41%. All is compared to the prior year quarter. 05:22 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 lens to China have remained robust as our distributor seeks to build inventory in…

13:48 Thank you, Caren, 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 sale. 14:13 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. 14:33 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 in 2022 was $49.3 million or 77.9% of net sales as compared to gross profit of $39.1 or 77.1% of net sales for Q1 2021, and $45 million or 76.3% of net sales for Q4 2021. 15:07 The 80 basis point increase in gross margin is compared to Q1 2021 is primarily due to geographic and product mix and decreased period costs associated with manufacturing projects. The 160 basis point 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 cost of manufacturing projects. For fiscal year 2022, we continue to expect gross margin to be approximately 77% of net sales. 15:41 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 of 2021. Operating expenses for Q1 2022 were approximately $3.3 million…

20:42 Thank you. [Operator Instructions] The first question today comes from Bill Plovanic of Canaccord. Bill, please go ahead. Your line is now open.

21:05 Great. Thanks for taking my questions. First, just on the ICL launch in the U.S., I mean I was wondering if you could help us understand the contribution in the first quarter, I know it was right at the end and how we should think about that? And then in terms of the guidance, the ramp into the year and maybe Caren I appreciate the fact on the, you know 100 docs trained, kind of how should we measure that as we go through the balance of the year? Is it 200, 300, 400 by the end of the year or is it just 100 or 200 high volume, kind of help understand some of the metrics in terms of accounts, reps, and maybe even ASPs to the Doc or patient? Thanks.

21:55 So, first of all, the contribution in the first quarter from EVO was negative. I mean, there was nothing in that quarter. It is Visian ICL, but there was a nice ramp up in Visian ICL and 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. 22:19 In terms of ramping up into the year, 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. 22:46 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's pretty much how we see the year, which is going to be pretty darn successful.

23:22 Yeah. Great and thanks for that level of granularity. Appreciate that. And then just my second question is for Patrick. On the manufacturing backlog, you know that's baked into the guidance. I think that was pretty clear that the [295] [ph], it kind of includes that work off of inventory. Kind of where did you end the quarter? And so, kind of how much do you expect to – and do you expect to have it all cleaned up by the end of the second quarter? Thanks for taking my questions.

23:51 Sure Bill. Thanks for the question. And so, yes, we did not call out backlog. And as we've said now, we hope to 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 Caren 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.

24:18 Great. Thanks for taking my questions.

24:23 Thank you. The next question today comes from Zach Weiner of Jefferies. Zach, please go ahead. Your line is now open.

24:32 Hey, thanks for taking the question. Congrats on a great quarter. I was curious if you can give some color on the distributor sales that were mentioned in press release? Are those sales in the first quarter or the beginning of 2Q? And how should we think of sales running through the rest of this year?

24:51 Okay. So, we talked about a 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 surgeons from our warehouses in China. 25:20 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. 25:50 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. 26:18 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'll go all the way in through September, to be sure we're very well prepared. 26:35 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.

26:58 That's helpful. Thanks very much.

27:03 Thanks Zach.

27:05 Thank you, Zach. The next question today comes from Ryan Zimmerman from BTIG. Ryan, please go ahead. Your line is now open.

27:15 Thank you. And congrats on the quarter and the progress. It's really fantastic to see Caren and Patrick. I wanted just to ask a couple of things in terms of, oh, sorry, yeah, thanks you're welcome. Just, I want to ask a couple of things around the buildup of inventory. And some of the dynamics in China, I know there's a lot of focus on this right now. I mean, Karen, if there's anything you can comment in terms of how much inventory, kind of needs to be built-up in the Chinese market ahead of the busy season, because they were somewhat depleted? And if I think back to 2020, there was a fear that we couldn't get product in the China and so some of it was confined. Do you anticipate needing to consign anything in the second quarter just given or excuse me, not consigned, excuse me, was consigned, but any fear that you have to consign inventory in the second quarter, just given some of the lock down dynamics that are taking place there?

28:18 No, for 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 [indiscernible] 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. 28:47 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. And 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. 29:20 I mean, that's what for us is critical and we manage it exceptionally well from our facility in Switzerland. So, 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 are 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.

30:05 Got that. I appreciate that color, Caren. And then just, you know a thing about the U.S. market, big picture longer-term, we have all these discussions about inflationary pressures and consumer demand and so forth and is there a different commercial strategy in your mind in terms of how you approach the U.S. market, relative to maybe some of your other markets like China or Japan, Korea, for example, in terms of how you think about price or how you think about promotions, you know things like that as we start to look at EVO launching in the U.S? Thanks for taking the questions.

30:48 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 refractory surgery is not inexpensive. However, there is no doubt that the mathematics associated with the decision to purchase are very much in favor of reflective 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. 31:32 So 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 are individuals who really value an active outdoor life. More women then actually at least at our last [indiscernible] between 25 and 35 years old. Their choices in their lives on health and happiness frankly tend to be some of the greatest in the world. 32:02 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 of 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.

32:34 Thank you, Caren. I'll get on TikTok and start following some of those influencers. I appreciate it.

32:40 You do that.

32:43 Thank you, Ryan. The next question today comes from Chris Cooley from Stephens. Chris, please go ahead. Your line is now open.

32:52 Good afternoon and thank you for taking the questions and congratulations on a great start to the year. If I may just, thinking back to just two weekends ago at [indiscernible] it was clearly a very powerful 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, it's prolific presence there as well. Could you just speak to, as just 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 kind of unique practices. At least perceives that at least early on and so just want to get a little bit more color on, kind of how you pick these practices and maybe while they're more resilient for you in terms of building a practice going forward, especially in this inflationary type environment? And I've got a quick follow-up.

33:50 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 Visian ICL surgeons and very comfortable in the eye, KOLs who were very excited about Visian ICL, but really wanted to get rid of the peripheral iridotomy as was evidenced at our special Friday Night Educational Event. 34:21 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. 34:38 And then we also wanted to make sure we had great representation in every major refractive market in the United States. And that we could begin to do a multimedia campaign in each of those markets effectively between now, especially in the end of the year when they're starting up. 34:55 So that story about 50% demand out of full demand for refractive procedures being EVO in a major market that's 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 we loved actually having a starring role to be blunt and honest. 35:19 And I think what we believe is that this training progression goes quite smoothly for those who already have successfully implanted Visian 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.

35:50 Thank you. I really appreciate all that additional color. And then maybe just lastly from me, when we think about utilization, obviously the label might be with and without a stigmatism down to minus 3 far more favorable in the old Visian ICL indication for use. Just curious how you see that broadening obviously, the opportunity you think is still going to be initially used by the higher myopes and then work its way down or is this going to be more front line day one for the lower myope? And then alongside of that, could you also update us on your strategy for the hyper indication as well? Thank you.

36:37 So, in terms of the myope and what the surgeon will offer in terms of minus 3 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 to all patients, which is what we found 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 incredible complement 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. 37:36 I think with Hyperopic we’ve 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 3, minus 7 in the United States in a bigger way than we could have imagined.

37:53 Thank you and congratulations.

37:55 Thanks, Chris.

37:58 Thank you, Chris. The next question today comes from Andrew Brackmann from William Blair. Andrew, please go ahead. Your line is now open.

38:07 Hi, good afternoon and thanks for sneaking me in here. Maybe I can just sort of ask on capacity. So, I think last quarter, Caren, you had said sort of a tripling of lens capacity here over the next 18 months or so. Any updates that you can provide us on that [effort] [ph]? And I guess bigger picture, can you just sort of talk about some of the assumptions that you have sort of driving that that's the right level of capacity that you need here, just trying to better understand the [payment process] [ph]?

38:34 Sure. So, what we decided to do is to triple capacity and what we’re, you know 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 as even possible. So, what our plan does is allows us to sell millions of lenses a year instead of hundreds of thousands of lens a year. 39:07 So, we're nearing to over 2 million lenses sold ICLs. We've got 1.5 million lens sold EVO’s. 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 our capacity to handle.

39:30 Makes a lot of sense and then, maybe just one more and sorry if I missed this Patrick, but as it relates to, sort of spending for the year, can you just sort of quantify how much of that sales and marketing spend is going to be specifically spent on, sort of the marketing for the U.S. launch? And then just, as we sort of think about the ROI there, any sort of KPIs that we should be looking at in terms for your ability to sort of create that brand awareness? Thanks guys.

39:56 Sure. Yes. So, we haven't broken out what percentage is going to the U.S. What I can tell you though that this is clearly an investment year of building brand awareness in conjunction with U.S. EVO approval, but as we've always said and as Caren said earlier, the U.S. market is a very strong market, but it also can be a global influencer across this. 40:17 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.

40:32 Yeah, it was just sort of around the KPI we should be looking at in terms of [Multiple Speakers] awareness.

40:36 Yes. 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 5, 10 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 and 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.

41:11 Okay. Thanks and congrats on the quarter.

41:14 Thanks.

41:16 Thank you, Andrew. The next question today comes from David Saxon from Needham. David, please go ahead. Your line is now open.

41:27 Yeah. Good afternoon, Caren and Pat. Thanks for taking my questions. Maybe starting off with EVO in the U.S., I know it's early days, but any stories or color you can share about what you're seeing in terms of EVO driving volume growth in prior Visian practices, at least in that initial group of 100 Docs, and expectations on how much of the longer-term EVO growth is going to be driven by increasing penetration in current ICL practices versus broader adoption?

42:02 Well, there are a number of prognosticators within refractive surgery about how big a piece of the action STAAR 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 in their search and satisfied and excited, I think that some of those higher numbers of percentage of opportunity for STAAR are probably in play. 42:33 We have a number of practices that are signing agreements. We have a number of practices that are asking for support with product development, with marketing, and when we put all that together, some surgeons of renowned think will be at 30%, sooner than we ever expected. 42:54 So really, 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 in a phenomenal job. I thank them very, very much. We have really great sales and marketing organization, distribution operations in the U.S. And I'm very pleased with their progress. 43:21 So, long answer, but 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.

43:34 Great. Yeah, that's super helpful. And just to clarify before I ask my second question, some surgeons think of, you will be at 30% sooner than expected, is that within their practices or is that the U.S. refractor there [indiscernible]? And then I'll just ask my second question, maybe for Pat. I know you're finishing up some manufacturing work, but any, sort of framework for how we should think about free cash flow for the year? Thanks so much.

44:10 So, with regard to surgeon 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 in a lens based future, taking over 50% share. 44:37 Then there are others that think there will be a s split between smile, laser vision correction, other LASIK vision correction, and STAAR, but any way you look at it, for us, this is a tremendous opportunity to make sure that a lens based future happens with the best possible lens on the planet, which is us. Patrick?

45:01 Yeah. Thanks Dave, it is Patrick. So, on the free cash flow, 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 of the big customers towards the end the quarter. 45:20 So, we're in very good shape. We'll have positive up 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, really depends on how the balance of the year goes, and then we'll come back if anything changes, but we're going to get spot from a cash standpoint.

45:48 Great. Thanks, and congrats on the quarter.

45:52 Thanks.

45:54 Thank you, David. This concludes the question segment of the call. I would now like to turn the call back to Caren Mason for closing remarks.

46:04 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.

46:23 Thank you. That concludes today's conference call. You may now disconnect your line.