STAAR Surgical Co (STAA) 2021 Q4 法說會逐字稿

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the STAAR Surgical Fourth Quarter and Fiscal Year Financial Results Conference Call. (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 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. (Operator Instructions) 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 achievement 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 3x to 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 of 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 US, 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 our ICL continues unabated through the first 7 weeks of the first quarter of 2022, including record orders from surgeons in China. Based on our current demand and supply forecast, we are reaffirming our previously provided outlook for fiscal 2022 net sales of approximately $295 million, subject to no unforeseen impact from COVID on our business. $295 million in net sales represents 28% year-over-year growth, which is an acceleration from our pre-pandemic level of growth in fiscal 2019 and would represent another record year of sales for STAAR. Patrick will provide details on the calendarization and composition of our sales outlook shortly.

Turning to the US. Our submission of clinical data for STAAR's EVO family of myopia lenses remains under customary interactive FDA review. While our expectation of pre-COVID approval time lines by the FDA has now passed, we remain confident regarding an approval of our PMA supplement. We will provide further comment on the process and our interactions with the FDA when permitted and appropriate to do so.

The US is the second largest market in the world for refractive procedures. We estimate that there are a very significant 100 million US adults, who are potential candidates for our implantable Collamer lenses. These adults are aged 21 to 45 with myopia in the range of minus 3 diopters and minus 15 diopters, which are our currently approved ranges in the US.

In 2022, we plan to invest more heavily in consumer awareness building programs designed to accelerate the paradigm shift to lens-based vision correction. We are seeking commitments from new and exciting celebrity brand ambassadors in the US and abroad, who plan to share their journeys to the visual freedom provided by our EVO lenses.

We will also continue to engage surgeons and their staffs globally through clinical validation, education and strategic cooperation in fiscal 2022. Our implantable Collamer lenses are suitable for a wide range of vision correction, which in some markets extends down the diopter curve to minus 0.5 diopters. I am pleased to report today that for the full year of fiscal 2021, almost two-thirds of our ICLs sold globally were in the range of minus 0.5 to minus 10 diopters.

In April, we will engage the ophthalmic community with a strong presence at the American Society of Cataract and Refractive Surgery, the ASCRS Annual Meeting in Washington, D.C., where we anticipate thousands of US surgeon and clinic attendees. Our Medical Monitor for our US study, Dr. Mark Packer, submitted his abstract to ASCRS and we look forward to sharing the clinical data at that time.

Later this year in September, we plan to host an Experts Meeting ahead of the European Society of Cataract and Refractive Surgery, the ESCRS Annual Congress, which is also historically attended by a strong contingent of global surgeons, where we plan to kick off the full commercialization of our presbyopia lenses. All told, we anticipate fiscal 2022 will be another record year of commercial and financial progress for STAAR.

Patrick?

Thank you, Caren, 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 product 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 product 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, 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 of ICL, partially offset by higher expenses related to manufacturing projects.

The sequential decrease in gross margin from the third quarter is due to lower ICL sales mix in Q4 at 90% as compared to 93% in Q3. For fiscal year 2021, gross margin was 77.5%. We expect Q1 and full-year 2022 gross margin to be approximately 77%, as we increase investments in manufacturing, including at our Nidau, Switzerland and Lake Forest, California manufacturing facilities.

Moving down the income statement. Total operating expenses for Q4 2021 were $37.6 million as compared to $30.2 million in Q4 2020, and $37.5 million for Q3 2021. Taking a closer look at the components of operative expenses, G&A expense for Q4 2021 was $11.5 million compared to $9.5 million for Q4 2020 and $11 million for Q3 2021. The year-over-year increase in G&A is due to increased compensation-related costs, facility costs and outside services. The sequential increase from Q3 2021 was due to increased compensation-related expenses.

For the full-year 2021, G&A expense was $44.1 million, or 19.1% of total net sales. For full-year 2022, we expect G&A expense to be approximately $13 million to $14 million per quarter. Selling and marketing expense was $17.1 million for Q4 2021 compared to $11.8 million for Q4 2020, and $18.2 million for Q3 2021. The increase in selling and marketing expense from the prior year was due to increased advertising and promotional expenses, compensation-related expenses, and trade show and meeting expenses due to the ICL awareness-building activities Caren mentioned earlier.

For fiscal 2021, selling and marketing expense was $67.3 million, or 29.2% of total net sales. For the full-year 2022, we expect selling and marketing expenses as a percent of sales to represent approximately 30% to 32% per quarter and to be at the higher end of this range in Q2 and Q3 to support sales during our busiest quarters.

Research and development expense was $9.1 million in Q4 2021 compared to $9 million for Q4 2020, and $8.3 million for Q3 2021. The sequential increase in R&D is due to increased compensation-related expenses, offset by a decrease in our US EVO clinical trial expense. For fiscal 2021, research and development expense was $33.9 million, or 14.7% of total net sales. And for the full-year 2022, we expect R&D expenses to be approximately $10 million per quarter.

Operating income in Q4 2021 was $7.4 million, or 12.5% of net sales as compared to $4.1 million or 8.8% of net sales for Q4 2020. The 370 basis point year-over-year expansion in operating margin was due to leverage on fixed and variable operating expenses during the quarter.

Operating margin for the full-year fiscal 2021 was a record 14.5%. We expect operating margin for full-year 2022 to be similar to fiscal 2021, as anticipated leverage on general and administrative and research and development expenses is offset by important investments in selling and marketing, targeted building ICL awareness and market share.

Net income in Q4 2021 was $4.9 million, or $0.10 per diluted share compared to net income of $3.3 million, or $0.07 per diluted share in Q4 2020. On a non-GAAP basis, adjusted net income for Q4 2021 was $9.5 million or $0.19 per diluted share compared to adjusted net income of $6.8 million, or $0.14 per diluted share in Q4 2020.

For the full-year 2022, subject to no significant change in our valuation allowance, we anticipate our tax rate by quarter and for the full year will be approximately 30%. A table reconciling the GAAP information to the non-GAAP information is included in today's financial release.

Turning now to our balance sheet. Our cash and cash equivalents as of December 31, 2021, totaled $199.7 million, up $47.2 million compared to $152.5 million at the end of the fourth quarter of 2020. The increase in cash is primarily attributable to $44 million in cash generated from operations. We invested $13.7 million in property and equipment in fiscal 2021. For the full-year 2022, we anticipate our CapEx will be approximately $20 million as we continue to invest in scaling our manufacturing infrastructure.

Finally, STAAR will be participating in the Canaccord Non-Deal Roadshow on March 10th and the Oppenheimer Annual Healthcare Conference on March 15. 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.

(Operator Instructions) Our first question is from Bill Plovanic of Canaccord.

It's [John] on for Bill. I just wanted to dive a little 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?

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

I can.

Okay. 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. And then just as a follow-up. Just maybe touching just on China and the Olympics. How should we think about the impact? The Olympics provide any unique branding opportunities for STAAR in China? And do you think that could portend to a stronger growth than what we seasonally see from China in Q1?

Well, as we addressed, the first 7 weeks of the year in China have 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.

Our next question is from Zach Weiner of Jefferies.

I just wanted to jump in on the backlog that you called out in your pre-announcement, you caught out 20,000 lenses. I believe that's consistent with the 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. It certainly gives us an opportunity to overperform.

Got it. That's helpful. And then just one on Viva. The launch, obviously, coming later this year in Europe. Any commentary on bringing the Viva lens to other markets outside of Europe? And if so, do you have any commentary on what the approval pathway would be either in US 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 Viva lens. And so we expect very good attendance in Milan unless, of course, there is another COVID spike. But without that we see in-person ophthalmic surgeon meetings being very well attended. And we expect that there will be countries approved in Asia and Europe that will benefit from the Viva playbook that we are building.

Got it. That's helpful. And then just one last one. For -- the guidance for 2022, does that include any potential revenue outside of the couple of million dollars pre-EVO Visian approval? Or is 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 we'll end up being. 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.

Our next question is from Chris Cooley of Stephens.

Caren and Patrick, maybe if I could just start just on the guide. I 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 think a little bit about the gating on the increased spend. I appreciate the color you provided on kind of a return to normalcy 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 from a consumer awareness perspective and also clinical education perspective? Just kind of how we should think about the gating of that? And I've got one quick follow-up.

Sure, Chris. This is Patrick. I'll fill that one. So as Caren 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 US market being the number one market. And we do believe the US 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 investment 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 US coming onboard a very, very robust growth rate over the next several years.

Appreciate that color. And just as a follow-up from me. When we think about just the US market in anticipation of Viva's FDA approval and then the subsequent commercialization here, it's a highly fragmented market when we think about the 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 somewhat rapid type of a launch post-commercialization that we should think about? Obviously, the KOLs going first, but subsequently, a much faster push into the broader market based on training and education.

So in the US market, we definitely will have a phased roll out. Obviously, our principal investigators, those who participated in the clinical trial, those who have our KOLs and have really strong refractive lens-based 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 that China has very large groups, as you well know, including the public company, Haier, 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.

Our next question is with Andrew Brackmann of William Blair.

Maybe just to start here. Can you maybe just sort of level set us on where capacity is just given all of -- sort of the supply chain issues that you've had in the US? And the reason I ask is this is really just sort of to level set investors sort of on that capacity ahead of the EVO US approval. I just want to make sure that we're crawling any fears as it relates to your ability to sort of satisfy that demand.

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 seem much stronger. We want to make sure that not only will we have the capacity, but that we will also have reserved inventory capability of about 30% to 40% of projected demand. So, we're in really 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 are expanding Monrovia aggressively.

And then maybe as it relates to the disclosure that 2021, I think you said about two-thirds of lenses were in that 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'd call out to sort of make sure surgeons are aware of that capability?

Sure, Andrew. Bottom line is the lens is approved for that wide range of diopter correction for a reason. 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 the higher diopter ranges because they have a higher correction need for a number of the people between the ages of 21 and 40. And what we've found out over time is there is so much satisfaction with attaining visual freedom that down the diopter curve, there is 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 individual to a minus 3, minus 4 or even lower to get really excited about what visual freedom really can mean. Because even if you're minus 2.5, minus 3, you still need your glasses quite a bit or you're wearing contact 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 surgeons allow the patient assuming that everything is right. Obviously, with regard to the pre-work by the surgeon, the work-up, everything is great and they are 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.

Our next question is with Ryan Zimmerman of BTIG.

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 28% growth, I look at kind of where you're at on China, where you're at on Japan. How do you think about the growth contributions from both China and Japan relative to that 28%? Are they accretive? Are they dilutive? Can you help us understand kind of what you expect out of those markets as it relates to your guidance in '22?

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.

And, Ryan, I think it's consistently what we've been saying for several quarters now, which -- yes, I was just saying, for several quarters, you've been talking about sort of these 3 pillars or phases of growth over the next several years. And as we said over the next, call it 12 months to 18 months, the primary growth drivers are non-US geographies, right? But as US EVO comes on board, it will take us 12 months 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 that we've talked about is, I think we had a question on Viva earlier. But that's really, as we said, thinking about the presbyopic market, [insert to] that third catalyst down the road. So as we've said, it's fairly modest US 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 US 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. And then -- again, you called that out in the 10-K around competition starting to emerge in Asia 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 around that, Caren, I think would 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 quite in the eye, 20 years successfully in the eye, a 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, if I can (technical difficulty) 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 disclosures that we put in there.

No that's -- 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 discussed, because our demand was so strong, this is 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 that the backorders are our made-to-order for our toric lenses. And so patients, there's not really another option for that. They tend to be higher diopter. And so we believe this is very, very sticky business. And as Caren said, demand continue to be very strong. We are making very good headway into the backorder position. We will make strong headway we believe in Q1, even more so into Q2, as we go into our largest seasonal quarter for the year.

Our next question is from Jim Sidoti of Sidoti & Company.

First, for me on CapEx. I think you said $20 million for the year, which is up considerably from 2021. What is this -- what is that on? Is that mostly equipment or facilities? Can you give us some color on that?

Yes. Sure, Jim. It's Patrick. So as Caren said, we're looking -- we got the question 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 is 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 approach US EVO approval and continued market penetration of our products worldwide.

And then can you also talk a little bit more about the tax rate? Why is it jumping up to 30% next year?

A little bit of cushion, maybe if we can bring that down a little bit, but there are some moving parts within that. And as well, one of the wildcards is our profitability by entity and with US EVO coming on board, that'll be a US tax rate. And that's a higher tax rate than our products that are being shipped out of Switzerland right now, which are at 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, US versus our Swiss tax structure.

Our next question is from Steven Lichtman of Oppenheimer.

This is David on for Steve. Maybe another question on the '22 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 7 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 reported for Q4 2021. So, we tried to take into consideration some 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 robust for us.

Okay. Great. And just a follow-up on head of the anticipated US approval. Could you provide any latest updates on your US commercial next initiative, including the ICL Experience Center?

So, we continue to work on the finalization of the planning as well as the construction of the Experience Center. 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 staffs 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 are doing today in 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.

Our next question is from Bruce Jackson of Benchmark Company.

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 with some of the facilities since you already manufacture there?

So, we have a regular regulatory required inspection timeframe. 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 inspections, 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 spent a year talking to doctors and getting a better feel for the procedure in the patient selection and making sure that everything runs smoothly. How does that affect the anticipated rollout? Is this something where you're going to train the physicians really 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 with the 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, are very much so involved in building what the questions will be that the surgeons who've used 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 timeframe 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 timeframe that we are 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. 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.

So 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.