Good day, ladies and gentlemen. Thank you for standing by. Welcome to the STAAR Surgical Third 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. [Operator Instructions] We will have approximately 45 minutes for today’s call. This call is being recorded today, Wednesday, November 2, 2022. 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 proceed.

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 third quarter ended September 30, 2022. On the call today are Caren Mason, President and Chief Executive Officer; and Patrick Williams, Chief Financial Officer. The press release of our third 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. STAAR achieved 30% net sales growth in the third quarter, which reflects strong EVO ICL unit growth in APAC and strong accelerating growth in the U.S. despite constant currency challenges and in Europe macroeconomic headwinds. In the third quarter, global ICL unit growth was up 40% year-over-year. We advanced our patient awareness, engagement and market building initiatives for EVO in the U.S. during and subsequent to the third quarter, highlighted by media campaigns with global entertainment celebrity, Joe Jonas and NBA player Max Strus and introduced our presbyopia lens EVO Viva to surgeons at our experts meeting preceding the Annual Congress of the European Society of Cataract and Refractive Surgeons. In China, we concluded another successful peak busy season that put EVO on track to exceed a 25% share of refractive surgery market units by year end. However, due to tighter COVID restrictions in China, resulting in expected delayed demand in the fourth quarter, ongoing headwinds in Europe, weakness in the yen and euro, and lower other products sales, we now anticipate total net sales will be approximately $285 million for fiscal 2022, which represents $300 million adjusted for constant currency. Our fiscal 2022 outlook includes ICL sales of approximately $272 million representing 28% year-over-year growth and other product sales of approximately $13 million. As you know, today, it is vital that STAAR focus on the significant growth opportunities we have with our premium EVO products. At the same time, our low-margin other products business, which represents approximately 5% of sales and consists of cataract IOLs, IOL injectors and injector parts, has faced increasing supply chain challenges. As a result of third-party materials and supply chain challenges that only affect our other products business we…

Thank you, Karen and good afternoon everyone. Total net sales for Q3 2022 were $76 million, up 30% as compared to $58.4 million of net sales in Q3 2021. The 30% year-over-year increase in Q3 2022 net sales is attributable to a 33% increase in ICL sales, which represented 95% of total company net sales in the quarter. On a sequential basis, Q3 2022 sales were down 6% from Q2 2022, which is similar to the year ago step-down in sales from Q2 to Q3. Q3 2022 reported net sales includes an approximate $4 million negative currency impact as compared to the prior year quarter due to changes in constant currency, primarily the Japanese yen and the euro. In constant currency, net sales for Q3 2022 would have been approximately $80 million, up 37% year-over-year. For the 9 months ended September 30, 2022, reported net sales includes a $9 million negative impact from changes in constant currency as outlined in the constant currency table in today’s earnings release. We currently anticipate approximately $65 million in net sales for Q4 2022, which contemplates tighter COVID restrictions in certain cities in China, resulting in an expected delay demand in the fourth quarter of approximately $5 million, ongoing headwinds in Europe of approximately $2 million, weakness in the yen and euro since our August 10 Q2 earnings call of approximately $1.5 million, and lower other products sales of approximately $1.5 million. Turning back to Q3, gross profit was $60.5 million or 79.5% of net sales as compared to gross profit of $45.3 million or 77.6% of net sales for Q3 2021 and $63.9 million or 78.8% of net sales for Q2 2022. The 190 basis point year-over-year increase in gross margin is due mainly to geographic and product mix partially offset by increased…

Absolutely. [Operator Instructions] Our first question today comes from the line of Anthony Petrone with Mizuho Group. Anthony, your line is now open.

Thanks. And I hope everyone is doing well. I will keep my two questions to the 4Q implied outlook as well as some of the statistics that were thrown out there for 2023. So when we look at the implied ICL guide for 4Q, it looks like $63 million to $64 million is implied and there was several headwinds called out currency delays in China shipments, maybe to just provide a little bit more color on how those headwinds are broken out? And then in terms of the implied U.S. outlook, you called out 100% growth in units, but we are missing sort of how we should translate that into dollars? And then I’ll have one quick follow up on ‘23.

Yes, this is Patrick, Anthony. Why don’t I kick off and then Caren might be on having some connection issues at the moment. So to answer your question – and Caren if you get on there please jump in. To answer your question, I tried to highlight in my prepared comments. So you are right, what we talked about and what you described is generally in the right direction, we guided to $65 million and very little contribution from the other products, which is our IOL legacy business. And then I did highlight in my prepared comments, we saw about $5 million of what we think is delayed revenue related to the tighter COVID lockdowns in China, couple of million dollars related to European macroeconomic factors. $1.5 million on FX side since our August 10 earnings call in Q2 and then another $1.5 million related to the IOL. So we try to bridge that gap and provide as much transparency as we could.

And then just the follow-up would be as we bridge it to ‘23 at $355 million predominantly mostly ICL, certainly calls for healthy growth year-over-year. Just wondering if you can provide a little bit more color geographically, what is contemplated in there for China growth, for instance, assuming we still have some lingering headwinds from COVID into ‘23? And then when we think about the rest of the geographies, of course, U.S. is on the launch phase and then we also have headwinds in Europe. So just how should we be thinking about the geographic makeup in 2023?

Hi, Anthony. This is Caren. I am happy to be with you today. I had a little bit of connection issue. So with regard to looking into…

Thanks, Caren.

Thank you. Looking into 2023, we believe that growth in China will still on a unit basis exceed that 30% range. We believe, as Patrick stated, this is delayed demand largely due to the fact that the recent election has for a number of individuals provided some concern about how COVID would be handled it seems to be a perception that COVID might in fact – the lockdowns might, in fact, be a little more challenging. So I think what we are hearing is that our big customers are hospitals, our clinics are very, very much looking forward to 2023. There is a belief that’s on social media hasn’t been validated yet, that in fact, the COVID lockdown principle will be changed and more favorable in terms of freedom of movement within China. So I think bottom line, we kind of look in 2023 for a resumption of great demand. With regard to the U.S., we are talking about very strong growth. We are talking way above this year’s growth in terms of percentages. We expect that within 18 months that the U.S. market will also be able to perform similar to China in terms of market share wins. With regard to Europe, we think that’s a little foggier in terms of when we expect Europe to really get out of a predictive recession, which seems to have a little bit of challenge. But again, I want to stipulate that we are in a growth mode in every market. We are stagnant nowhere. It’s just when is demand going to be at its greatest in light of the macroeconomic trends, some of the political challenges, etcetera, but overall, we see nothing, but blue sky ahead.

Thank you very much. I will get in queue. Thank you.

Thank you, Anthony.

Our next question today comes from the line of Margaret Kaczor with William Blair. Margaret, your line is now open.

Hey, good afternoon, everyone and thanks for taking the question. I wanted to follow-up just to start on the China comments. It could be wrong, but it seems like that’s just the first time that at least I have seen you guys kind of mentioned the COVID lockdowns in the 3 years. Maybe the Presidential election, but maybe any other commentary you could provide on what it could indicate for 2023. Is it pulling back and not only delaying, but what’s the base that we should look at, I guess for that 30% growth?

Thank you, Margaret, for joining us today. The basis for the 30% growth is built on what we know already contractually with strategic agreements as well as focus of the team on all the critical accounts in the major markets, the fact that we are preparing with the appropriate amount of what are our toric lenses, which continue to grow in demand even above our spheric growth. We already are aware where the hospitals and clinics are planning for 2023 as we plan along with them. The reason why the fourth quarter has a question mark is because right after the election over the last week to 1.5 week, there have been behaviors by consumers and employees such as you saw may have read about Foxconn, which is making people a little hesitant about how the government may react to the freedom around COVID. And what can happen if you happen to be in the wrong place at the wrong time with an outbreak? Will I end up not being able to make it home? These kinds of concerns are different than what we experienced in the other COVID challenges throughout the last 2.5 years. So we have decided rightfully to be prudent to ship the right amount of inventory to prepare for a strong 2023.

Okay, great. I appreciate that color. And then let’s maybe shift to the U.S. the 550 surgeons are trained at this point, obviously a very good number. It seems like maybe you are pointing towards more of an inflection in the back half of the year and something maybe you can tell me whether I am right or wrong on that. And then any color on the profile of the 550 practices that they are in and whether or not they are planning on converting maybe a large portion of patients to EVO or just adding is an option for those that aren’t eligible for LASIK response? Thanks.

So in the United States, we believe that the enthusiasm for this expansion of the U.S. market which we believe will happen with EVO lens based technology is just beginning. So, we are training the most interested surgeons first, obviously, the ones who have committed from the very beginning just signed a strategic agreement with STAAR want to get started as soon as possible. Just a personal note, the other day, my husband and I went to outstanding surgeon in San Diego, Dr. Sandy Feldman. And it was fun because when we got the door, there was the major, Joe Jonas poster, Florida ceiling with people gathered around it. And I do not exaggerate a lot of enthusiasm by her entire team. And this was just on my personal visit, you can imagine that this is being replicated around the United States. And so in terms of moving the business model in the right direction, that takes a little while, because you are going from a LASIK-based practice to a lens-based practice. And as result of that, when we talk about training surgeons and how quickly they are going to move their business over to lens-based EVO, it varies. But we found everywhere else, including our largest markets around the world, that within 12 months to 18 months, you start to see some really strong movement by some of the largest providers around those major markets. So, our expectation is in 2023, we will have really, really strong growth. We still want to be 10% of the market by the end of next year, going into 2024 and 20% by 2025. So, these are big numbers, but we believe we are going to meet them. And we think that the rollout as it has been over the last several weeks especially continues to be very strong.

Thanks guys.

Thank you. Our next question is from the line of Bill Plovanic with Canaccord. Bill, your line is open.

Hi, Caren and Patrick. It’s John on for Bill Plovanic. Thanks for asking our questions. I just want to follow-up on Margaret’s question. Could you talk about this early U.S. users? Have you been able to convert any exclusive laser only clinicians? And do you see practices today, especially the laser only users? Do they have the infrastructure facilities today support doing the procedure or they need to build those out? Thanks.

Thank you, John. So, it really depends on the practice. In terms of whether or not they have a strong cataract practice, if they are doing premium cataract lenses, assuming they have never done EVO lenses, even in the previous Visian type of lens. So, let’s say that you are not doing a lot of intra-ocular procedures. It’s probably going to take you a little longer to move your practice model and your clinical confidence then it will be for those surgeons who are very comfortable on the eye, either having used our EVO lenses known as Visian before, and/or they are very good at refractive lens exchange premium cataract lenses, etcetera. So, it varies. But there are a number of surgeons who are moving aggressively to go from maybe not all LASIK base to our lens base that quickly, but certainly from a mix of procedures to weigh more EVO. So, that I would say would identify probably the greatest pickup and the greatest users we currently have.

That’s really helpful. Thank you. As we are thinking about Q4 and when you have spoken about China and the softness there and setting up for ‘23, are there any updates that the backlog that was existing, and how can you use this period to maybe able to catch up by the year end?

Yes. So, first of all, I just and I appreciate because we are reporting 40% growth quite often, but it appears that Q4 is soft, it’s not shocked. We are still looking at China 22% to 25% growth of units. It’s just not going to be 30% to 35%. In the fourth quarter while we are delayed as people are trying to figure out how this COVID challenge plays out. In terms of what we expect going forward, it is that these strong growth numbers will continue.

Okay. Thank you. And then just to sneak one last one into the other products discontinuation. I know that product line was important to some KOL surgeons, though U.S., do you expect any impact to ICL use because of that phase out. Thanks again for taking my other questions.

No, we do not, the users of our IOLs and injectors and injector parts, they are at this point, very happy with STAAR’s lens that we are going to make sure as we have as we moved out of the IOL business and other markets, that there is a long lead time. And that we are very supportive to provide inventory until they find alternative sources for their IOL lenses and injector parts. We are really talking about two markets. And really, our hope is that the ICL business will be even stronger in conversation in those markets where IOL business has really been, not a focus for us for a long time, a bit of a downward cycle. So, we are only going to be talking positives going forward. And we see our ICL business picking up just fine in those markets as well.

Thanks Caren.

Thank you. Our next question is from the line of Zach Weiner with Jefferies. Zack, your line is open.

Hey, everyone. Thanks for taking the questions. I just want to touch on the U.S. market. It looks like looking at the Q that was released, it looks like U.S. was flat sequentially this quarter. Can you just give some color on performance in the quarter in the U.S. and how we should be thinking about it in the fourth quarter?

So, Patrick, why don’t you take that one. I do not believe it was flat sequentially.

You are correct. So, let me go pull up, maybe see what you are seeing exactly. No, we were up actually on revenue closer to 75% year-over-year. I need to go look at the sequential again to double-check that. But as Caren said in her prepared comments, we expect unit growth to be going from 66% year-over-year in Q3 to 100% in Q4. And then as you said, even as we go through 2023 continue to see even larger market share gains as we move to 2023.

Apologies I missed, mostly that was the wrong thing. And I guess just looking at the China performance, how do you look at procedure volumes through the quarter? And how should we think about through 2023? Thanks.

So, as I have said, we expect that procedure volumes in China in the fourth quarter will be from a growth trajectory 22% to 25%, and then 2022 to 2023, 30% plus. So, that if we consider that strong healthy growth.

Thanks for taking my questions.

Thank you. Our next question comes from the line of Ryan Zimmerman with BTIG. Ryan, your line is open.

Good evening and thanks for taking the questions. Just to follow-up on the last question, point of clarification. I think your revenue in the second quarter was 3.872, based on the Q and you guys did 3.873 in the U.S. Maybe some of that’s injector sales and I appreciate that the units are up. But I guess the question goes to just the fact that U.S. growth sequentially, on the EVO launch, Caren, if you could just speak to that. And I think implied with the 100% unit growth, I am coming out to about $5.3 million for the U.S. in the fourth quarter and just hope, want to check my math on that and see if that’s what you are kind of expecting for the U.S. in fourth quarter.

Well, so if you are checking math, I will turn it over to the greatest guy in finance, and that’s Patrick.

Yes. So, there is a little bit of noise in there on the domestic side related to perhaps some Canadian and North America, so you can’t quite get apples-to-apples on that one. In terms of your math of looking at Q4, I would say directionally, you are headed in the right direction. That as Caren has said, we expect to get greater market share gains as the product is in the market longer. As a reminder, the fourth quarter that we are currently in, this is only the third quarter of commercialization. And so as we have been very consistently saying, we expect to see bigger gains as we move through 2023 and certainly as we exit 2023 in terms of contribution from U.S.

Okay. Appreciate that color and the clarifications. On the series number to the 355, I would appreciate your thoughts, either Patrick or Caren around just the impact of units versus price. And how much price you expect to pick up maybe next year at the U.S. becomes a larger proportion of sales relative to the unit expectations that you are guiding to on an underlying basis.

Patrick?

Sure. So, on that one, what I would say is that we have a very healthy ASP in the U.S. In terms of our ASP, we don’t see a lot of pressure on ASPs at all, because of the nature of our strategic alliances globally. We know exactly what we are going to get in terms of pricing and that’s set for the forthcoming year. Where we do see a mix in ASP is going to really come from either product mix, which where we see more toric or with spheric, toric being a higher ASP. And of course, the geography mix, which is what your question was on the direct side for the U.S. Still, the U.S. is a relatively small piece of the revenue contribution. So, it’s really not going to move the needle that much. In fact, if you look at our revenue in the U.S., as we have said, we were 66% on units, and actually higher on revenue growth year-over-year because of the higher ASP. So, hopefully that answers your question, Ryan. I think we are – as we said is, it’s still a relatively small piece of the contribution. But as we move through 2023, then I think those questions will be a lot more viable in terms of modeling.

So, just a clarification then, the 355, and the implied 30% growth essentially equates to 30% unit growth, or there is some price impact in there, as dice – the other sales diminish?

Yes. We would expect a slightly higher unit growth. But I think to your point, as the U.S. is starting to come onboard with a higher ASP, that differential is perhaps not as great as it’s been in the past when we were more concentrated with lower Asia market pricing such as China.

Okay. Appreciate the color. Thanks. Thanks for taking my question.

Thank you, Ryan. We are showing no more questions in queue. So, I would like to now turn the call back over to Caren for closing remarks. End of Q&A:

She might have dropped off with some connectivity. So, I will chime in and appreciate everyone’s participation today. We look forward to seeing you at these upcoming conferences. And we appreciate your interest and investment in STAAR Surgical and the best to everyone.

That concludes today’s call. Thank you for your participation. You may now disconnect your lines.