Good day, ladies and gentlemen. Thank you for standing by. Welcome to the STAAR Surgical Fourth Quarter and Fiscal Year 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. [Operator Instructions] This call is being recorded today, Wednesday, February 23, 2022. At this time, I would like to turn the conference over to Mr. Brian Moore, Vice President, Investor, Media Relations and Corporate Development for STAAR Surgical.

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 fourth quarter and fiscal year ended December 31, 2021. On the call today are Caren Mason, President and Chief Executive Officer; and Patrick Williams, Chief Financial Officer. The press release of the fourth quarter results was issued just after 4:00 P.M. Eastern time and is now available on STAAR's website at www.staar.com. Before we begin, let me quickly remind you that during the course of this conference call, the company will make forward-looking statements. We caution you that any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the company's projections, expectations, plans, beliefs and prospects. These statements are based on judgment and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties associated with the forward-looking 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. 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 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 Caren Mason, President and CEO of STAAR.

Thank you, Brian. Good afternoon, everyone, and thank you for joining us on today's call. The fourth quarter results we reported today are consistent with the preliminary results we announced last month. Fourth quarter results contributed to another record year of sales, profit, cash flow and growth achievements for STAAR in fiscal 2021. We achieved all of this despite some ongoing COVID and operations related headwinds. Our results were driven by global ICL unit growth for the full year fiscal 2021 which was up 48% year-over-year and almost three times the 17% increase in global industry refractive procedures. Turning to the fourth quarter, we achieved strong growth in several markets, including ICL unit growth in China, up 44%, Japan up 45%, South Korea up 35%, India up 74% and Latin America up 30%, all as compared to the prior year quarter. All the major regions we track achieved positive ICL unit growth year-over-year for the fourth quarter of 2021. European geographies, as many of you know, were most impacted by the emerging Omicron COVID variant during the fourth quarter of 2021. COVID impacted certain of our European customers and in the U.S. STAAR's manufacturing operations. Employee absenteeism was the major headwind in both cases, with staff and employees quarantining at various times during the fourth quarter, mostly due to household or contact tracing COVID protocols. We believe the worst of these headwinds are now lessening. Global demand for ICL continues unabated through the first seven weeks of the first quarter of 2022, including record orders from surgeons in China. Based on our current demand and supply forecasts, we are reaffirming our previously provided outlook for fiscal 2022 net sales of approximately $295 million subject to no unforeseen impacts from COVID on our business. $295 million in net sales represents 28%…

Thank you, Karen and good afternoon everyone. Total Net sales for Q4 2021 were $59 million up 28% as compared to the $46 million of net sales in Q4 2020 and up 1% on a sequential basis from Q3 2021. The year-over-year increase in net sales was attributable to a 33% increase in ICL sales, partially offset by declines in other products sales. As Caren mentioned, our outlook for fiscal 2022 is net sales of $295 million. We anticipate returning to a more normal pre-pandemic calendarization of sales in 2022, with approximately 48% of net sales in the first half of the year, which is consistent with our 2019 results. As a reminder, Q1 and Q4 have historically represented our seasonally lowest quarters. We expect net sales for Q1 2022 to be similar or slightly up from Q4 2021 and Q2 net sales to still represent our seasonally highest quarter for the year. Turning back to Q4 2021, in terms of product mix, ICL sales represented 90% of total company net sales for the fourth quarter, as compared to 87% of total company net sales in the year ago quarter. Other product sales represented 8% of total company net sales for the full year fiscal 2021 and for the full year fiscal 2022 we anticipate other products sales will be approximately 5% of total company net sales as our ICL business continues to grow at a much higher rate. Gross profit for Q4 2021 was $45 million or 76.3% of net sales as compared to gross profit of $34.3 million or 74.6% of net sales for Q4 2020 and $45.3 million dollars or 77.6% of net sales for Q3 2021. The 170 basis point increase in gross margin as compared to Q4 2020 is primarily due to the higher mix…

[Operator Instructions] Our first question is from Bill Plovanic of Canaccord.

Hi, it's John on for Bill tonight. Thanks for taking our questions. I just wanted to dive a bit deeper on where you are currently in your discussions with the FDA. Can you just talk about have you begun discussing the label and or the post approval study?

Hi, this is Caren. Thank you for joining us today, John. Can you hear me okay?

I can, thanks Caren.

Hey, great. So what we said in the script remains true. We are in customary interactive review with the FDA and we really don't comment any further as to process or progress other than to tell you confidently that we feel very good about getting a positive result for our submission.

Got it. Thank you, Karen. And then just as a follow up, just maybe touching just on China and the Olympics, how should we think about the impacts the Olympics provide any unique branding opportunities for STAAR in China? And do you think that could portend to stronger growth than what we seasonally see from China in Q1?

As we addressed the first seven weeks of the year in China had been particularly strong. We had record orders from surgeons and so obviously, we've had a lot more patient flow. And I can't say that that's attributed to the Olympics. But what I can say is that there is a lot of positive progress with regard to social media and digital marketing, as well as a lot of streaming media associated with the benefits of EVO. And so, we continue those great programs very successfully and so we attribute that and a lot of the great work of our team in China and the outstanding work of the surgeons in China to why EVO continues to gain market share in refractive procedures in China.

Thanks, Caren.

Thank you, John.

Next question is from Zachary Weiner of Jefferies.

Hey, thanks for taking the question. I just wanted to jump in on the backlog that you called out in your pre-announcement, you caught up 20,000 lenses. I believe that's consistent with this 3Q release also. Just curious where backlog currently stands and if any of that backlog is factored into full year 2022 guidance?

So thanks for joining us Zach. In terms of backlog, yes we continue to have a healthy backlog. Some of that is figured in, but I wouldn't be surprised with momentum as strong as it is with current orders and backlog. You know it certainly gives us an opportunity to over perform.

Got it, that's helpful. And then just one on Viejo, the launch obviously coming later this year in Europe any commentary on bringing the Viejo lens to other markets outside of Europe? And if so, do you have any commentary on what the approval pathway would be either in U.S. or in China?

So we have a number of countries where we are in regulatory review. We expect that by the time we have our experts meeting in Milan, in September, there will be a number of markets open for the Viejo lens. And so, we expect very good attendance in Milan and then of course there is another COVID Spike. But without that we see in-person of Thalmic surgeon meetings being very well attended. And we expect that there will be countries approved in Asia and Europe that will benefit from the Viejo playbook that we are building.

Got it, that's helpful. And then just one last one, the guidance for 2022. Does that include any potential revenue outside of the couple of million dollars pre-EVO Visian approval, whereas FDA approval not factored into current 2022 guidance?

We have a modest amount of 2022 volume in our guidance. Obviously again, we'd love to overachieve, but we are being very prudent in terms of what timing will end up being and but we're very confident. I tell you that, that we're ready. So we'll give it all we have, but we have a very modest amount yes, in our 2022 guidance at this time.

Perfect. Thanks so much for taking the questions.

You're welcome, Zachary.

Our next question is from Chris Cooley of Stephens.

Good afternoon, and thanks for taking the questions. Caren and Patrick, maybe if I could just start just on the guide, just want to make sure we're thinking about this correctly and then I've got a follow up. But on the guidance, help us to think a little bit about the gating on the increased spend. I appreciate the color you provided on kind of return to normality, when we think about the top line and the seasonal trends there. But help us think about how you make these incremental spend through both, both from a consumer awareness perspective and also clinical education perspective, just kind of how we should think about the gating of that? Then I've got one quick follow up.

Sure, Chris, this is Patrick I'll field that one. So as Karen and we said in our prepared comments, this is really a big year for us as we look to increase the brand awareness of EVO worldwide, especially with the pending approval that we see on the U.S. market being the number one market. And we do believe the U.S. market will be able to drive a global influence for us. And so that's what you're seeing in the color that we gave around the uptick in investments in sales and marketing, the rest of the business, R&D, G&A some modest increases there as we continue to scale. So nothing I would say really worthwhile there other than scaling to approaching $300 million plus company and starting to prepare us for what we hope to be with the U.S. coming onboard a very, very robust growth rate over the next several years.

I appreciate that color. And just as a follow up from me, when you think about just the U.S. market and anticipation of EVOs FDA approval and the subsequent commercialization here, it's a highly fragmented market when we think about this space versus what you have, for example, in China. Can you help us think a little bit about those kind of how we should think about the rollout? Is this an initial focus on KOLs and get good traction and then expand over time? Or is this a more rapid type of a launch post commercialization that we should think about? Obviously, the KOL is going first, but subsequently, much faster push into the broader market based on training and education? Thanks so much.

Thank you, Chris. So in the U.S. market we definitely will have a phased rollout. Obviously, our principal investigators, those who participated in the clinical trial, those who have our KOLs and have really strong refractive linspace practices as part of their goals. We will work with all of them to make sure that we have a very outstanding business model. At the same time that we provide outstanding clinical training to the surgeons and their teams, and get them certified appropriately and quickly. So it won't be identical to China, but it will be very close to China. And I say that because the surgeon experience and the patient experience will be very similar in China. The difference is, is that China has very large groups, as you well know, including the public company [indiscernible] higher and university hospitals that buy in larger quantities at a time. But in the US, we're really only about 300,000 to 350,000, or about 30% smaller than China. So it's a little more spread out, but we also have very large implanters. So we're doing our work very diligently to make sure that we meet the market requirement, and that we also phase in quickly and aggressively.

Thank you.

Our next question is with Andrew Brackmann of William Blair.

Hi Caren, Patrick Brian, good afternoon, and thanks for taking the questions. Maybe just to start here, can you maybe just sort of level set up on where capacity is, just given all of sort of the supply chain issues that you've had in the U.S.? And the reason I ask you this is really just sort of to level set investors sort of on that capacity ahead of the EVO U.S. approval, I just want to make sure that we're quelling any fears as it relates to your ability to sort of satisfy that demand? Thanks.

Thanks, Andrew, thanks for joining us. In terms of capacity, we are working diligently to triple our current capacity within the next 18 months. And so if we look out in terms of volume, as we see it, and growth in the 30% plus range for units each and every of the next several years, of course, even we think some years being much stronger, we want to make sure that not only will we have the capacity, but that we will also have reserve inventory capability of about 30% to 40% of the projected demand. So we're in really a good place. We should be opening our Nidau, Switzerland facility by the end of the year and Lake Forest, California by next year. Plus, we're expanding Monrovia aggressively.

That's great. Thank you for that. And then maybe as it relates to the disclosure that 2021 I think you said about two thirds of [indiscernible] 0.5 and negative 10 diopter range. Can you just sort of talk about sort of the migration down that curve from a surgeon perspective? Is there anything sort of specifically that you're hearing that surgeons are making about the lens that surgeons are more comfortable in sort of moving down that curve. And then as it relates to sort of what you're doing around that any marketing that you call out to sort of make sure surgeons are aware of that capability? Thank you.

Sure, Andrew. Bottom line it is, the lens is approved for that wide range of diopter correction for vision. What we have worked on over the past years is to validate through clinical studies the rationale behind that range of correction. And you may remember, I'll remind you that when we went to China, there was a real belief at the time and most of Asia by the way, that we would only be in a higher dioptre ranges because they have a higher correction need for a number of the people between the ages of 21 and 40. And what we found out over time is there's so much satisfaction with obtaining visual freedom, that down the diopter curve, there's tremendous interest. And because we have some unique advantages around the lens, around dry eye syndrome, as well as night vision biocompatibility and so many others, that social media is really rallying individuals who are -3, -4, or even lower to get really excited about what visual freedom really can mean, because it's even if you're -2.5, -3 you still need your glasses quite a bit or you are wearing lenses. So to truly get visual freedom for a number of these patients with the advantages of our EVO lenses, we are getting a lot of increase. Lower down the diopter curve surgeons are very comfortable with the procedure. Most markets the surgeons allow the patient assuming that everything is right obviously with regard to the pre-work by the surgeon, the workup, everything is great. And they're eligible for EVO, then they can have whatever they like. And we're finding that very high level of interest in and selection of EVO.

That's great. Thank you.

Thanks, Andrew. Our next question is with Ryan Zimmerman of BTIG.

Hey, Caren, Patrick, and Brian, thanks for taking the questions. Congrats on all the progress this year, it's been very encouraging to see. I guess, I want to ask about the guidance Caren for 2022. When you think about that 22% growth and look at kind of where you're at on China, where you're at in Japan, how do you think about the growth contributions from both China and Japan? relative to that 20%? Are they accretive? Are they dilutive? Just help us understand kind of what you expect out of those markets as it relates to your guidance in 2010?

So even though the base in those markets are significantly higher than others in terms of market share, as well as in China, of course, total net volume, we still have the same aggressive growth rates that we projected a few years ago. As a matter of fact, we talked today about the fact that we're looking at 28% growth total. So bottom line is, we still expect those strong numbers in those markets.

All right, and I think it's consistently what's been saying for several quarters now, which, yes, just say for several quarters, you've been talking about sort of these three pillars or phases of growth over the next several years. And as we said, over the next call it 12 to 18 months, the primary growth drivers are non-U.S. geographies, right. But as U.S. EVO comes on board, it will take us 12 to 18 months for that product to really get up to a critical mass and that will be the second phase of growth for us. And then the third phase we've talked about is I think we had a question on Viva earlier, but that's really as we start thinking about the presbyopic market, insert of that, that third catalyst down the road. So as we said, it's fairly modest U.S. contribution, but the sooner we get that approval, we're very excited to get going on it. And we've got the big ASCRS coming up as well, which will be what we hope to be a very nice, hopefully, a grand opening for U.S. EVO, Dr. Packer is going to be talking about. He submitted his abstract as well on the data there, so we're excited about that.

That's helpful. Thank you. And then I can't help you called it out in the 10-K around competitions starting to emerge in Asia. And, and I'd be remiss if I didn't ask about it, we do get that question from investors. And what -- is this a concern and what can you say about it? I imagine your IP is pretty strong, but your comments are around that Caren, I think will be appreciated by investors.

Sure. So yes, there definitely are companies that are in some phase of development or clinical study around an implantable contact lens. We are the only company with an implantable Collamer lens. So when we think about competition, and we think about the biocompatibility required in the eye, 20 years successfully in the eye material that is far superior to cataract lens material, which has much less work to do in a mesh like cover, so to speak. Bottom line is, we are aware of other competition. There are other competitors now being manufactured in India, and Europe. And we are the only company that has this proven test of time extraordinary material that has exceptional safety record and exceptional efficacy record.

And Ryan, I just want to follow up because you brought up the 10-K. As you know, a 10-K is a very comprehensive document, which includes risk factors as well. And so, clearly in our prepared comments in our press release and what we openly said we do address competition, but it's not something that at this point we see as a headwind for us, but in the 10-K document, it's a very different as you know, set of posers that we put in there.

Now that's, I appreciate that Patrick. I just was reading through it as the call was going on, if I could squeeze one more in on the backlog, and it's already been asked about, but is there any risk in your mind or does the guidance assume anything in terms of loss to the backlog, it still stands around 20,000 as I recall, as we head into 2022, but is there any risk that patients could walk away, if you will, to other refractive options?

No, we don't see that. And as we've described it, there's a couple of characteristics of the backlog. One of them is, as we've discussed, because our demand was so strong, this was really more of a supply. And on the supply side, because we cannot hit these demand numbers because it really just ran away from us. We decided to do an allocation and so we allocated and really satisfied most customers, except for really our largest customer sitting in China. On top of that, we tend to see the backwaters are our made to order or our Toric lenses. And so patients, there's not really another option for that and they tend to be higher diopters. And so, we believe this is very, very sticky business. And as Caren said, demand continues to be very strong. We are making very good headway into the backorder position. We will make strong headway we believe in Q1 and even more so into Q2 as we go into our largest seasonal quarter for the year.

Okay, thanks for answering all my questions, guys. I'll hop back in queue.

Yes, of course. Enjoy skiing and snowboarding.

Our next question is from James Sidoti of Sidoti Company.

Hi, good afternoon. Thanks for taking the questions. First on the CapEx, I think you said $20 million for the year, which is up considerably from 2021. What is this? What is going on, is that mostly equipment or facilities? Can you give us some color on that?

Yes, sure Jim, Patrick. So as Karen said, we're looking, we got the questions, to triple our capacity. We did about $14 million in CapEx. The high majority was related to manufacturing expansion. The approximately $20 million that I called out in our prepared comments, primarily the high majority of manufacturing expansion. So that's that tripling of the capacity you'll see Nidau, Switzerland coming online, Lake Forest coming online even more. Our Monrovia facility expanding out even further, we talked about that in our prelim announcement, where we doubled our square footage footprint there. So, all good things and we're in very good shape as we approached U.S. EVO approval and continued market penetration of our products worldwide.

And then, can you also talk a little bit more about the tax rate what it was jumping up to say 30% next year?

No, a little bit of cushion. Maybe you know, if we can, know, bring that down a little bit. But there's some moving parts with tax. And as well, one of the wildcards is our profitability by entity. And with U.S. EVO coming on board, that will be a U.S. tax rate, and that's a higher tax rate than our products that are being shipped out of Switzerland right now, which are a far less tax rate. So it's really just more of a geography mix related to the tax structures of various countries, in this case U.S. versus our Swiss tax structure.

Got it. Thank you.

You're welcome.

Our next question is from Steven Lichtman of Oppenheimer.

Hey, guys, this is David on for Steve. May be another question on the 2022 guide, does that assume any continuation of the COVID impacts seen during the fourth quarter related to supply disruptions and absenteeism and any thoughts on when these headwinds should abate?

Yes, no, I think in the prepared comments Caren talked about the fact that we've had a very strong seven weeks now to the beginning of the quarter. And so, in my prepared comments I talked about revenue would be similar to slightly up from the $59 million that we just recorded for Q4 2021. So we've tried to take into consideration that potential headwinds related to COVID as we came into the 2022, but at this point, things seem to be clearing up which I know everyone is keenly keeping their eyes on. So we're feeling very good about where the business is at, so we expect to close the quarter strong and we expect to have a very hopefully record breaking once again Q2 for us, and we gave a lot of color around the second half revenue for the company will as well be very, very robust for us.

Okay. Just a follow up on, how do you anticipated U.S. approval, could you provide any latest updates on your U.S. commercial initiatives including the ICL experience? Thanks.

So, we continue to work on the finalisation of the planning as well as the construction of the experience centre. We still expect it to open in mid-summer. So we're very excited about what training opportunities and experiences we can provide for surgeons and their staff, in terms of how to build a really terrific clinical model, as well as having some really strong marketing support, as well as the appropriateness of the clinical work. So, with all of that being visible and experienced, we expect that to be a very strong addition to what we're doing today partnering with surgeons and their staffs. So, we're really looking forward to that. In terms of other marketing, everything that we would do for EVO, we'll talk about in detail in the future calls.

Okay great. Thank you.

Our next question is from Bruce Jackson of Benchmark Company.

Hi, good afternoon. Thanks for taking my questions. About the manufacturing expansion, can you just remind us about the FDA requirements for these expansions? Do all of them require inspections before you can start shipping product or is it an administrative type of process that you have to go through for some of the facilities, since you already manufacture there?

So, we have a regular regulatory required inspection time frame. Some of them are scheduled and some of them are not. Assuming that we stay within our current processes, SOPS, then it is more about informing rather than requiring inspection, but that's always up to the regulatory body to determine.

Okay, that's helpful. And then a follow up question on the presbyopia lens in Europe. So, you’ve spent a year talking to doctors and getting a better feel for the procedure and the patient selection and making sure that everything runs smoothly. How does that affect the anticipated rollout? Is this to something where you can train the physicians very carefully? And it’s going to be sort of like a very slow, steady rollout or is this something where you've got the process nailed down to the point where you can maybe roll it out a little bit faster?

Well, our intention all along was that surgeons would be the best at using the product in its early rollout, which is occurring now. They would be able to, some of them especially expertly determine the best patient selection criteria and patient management criteria, as well as post implant follow up. And so, this has always been about surgeons training surgeons. That playbook will be built by them and it will also be on the podium, as well as available in print from the surgeons. At our experts meeting, our expectation is that there will be panels associated with those surgeons, those who have questions obviously, very much so involved in building what the questions will be that the surgeons who use the lenses will field, but there will also be a lot of advice and a lot of training. So, in terms of what the pace will be post the completion of this process, when we say full commercialization, we mean the lenses will be available to each market as we are sure we can achieve the appropriate training time frame and certification and then followed by making sure that we have a very good lead time on the lenses. So, my expectation is that this time frame that we're using is going to be very effective to make the rollout much smoother, much easier and potentially faster in terms of getting lenses into the hands of surgeons globally.

Okay, that's great. Thank you very much for taking my questions and congratulations on the progress.

Thank you very much.

That concludes our Q&A session. So, I would now like to pass the conference back to Caren for any closing remarks.

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

That concludes our conference call. Thank you for your participation. You may now disconnect your line.