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spk09: Good morning. Welcome to Establishment Labs' fourth quarter 2021 earnings call. At this time, all participants' line will be in listen-only mode. At the end of this call, we will open the line for a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. I will now turn the call over to Raj Dhanoi, Interim Chief Financial Officer, Please go ahead.
spk05: Thank you, operator, and thank you, everyone, for joining us. With me today is Juan Jose Chacon Quiroz, our chief executive officer. Following our prepared remarks, we'll take your questions. Before we begin, I would like to remind you that comments made by management during this call will include forward-looking statements within the meanings of federal securities laws. These include statements on Establishment Labs' financial outlook and the company's plans and timing for product development and sales. These forward-looking statements are based on management's current expectations and involve risks and uncertainties. For discussion of the principal risk factors and uncertainties that may affect our performance or cause actual results to differ materially from these statements, I encourage you to review our most recent quarterly report on Form 10-Q and other SEC filings, which are available on our website at establishmentlabs.com. As a reminder, Establishment Labs received an investigational device exemption from the FDA for Motiva implants and is undergoing a clinical trial to support regulatory approval in the United States. We continually seek to expand the geographies in which our products are regulatory approved. Please check with your local authorities for specific product availability. The contents of this conference call contains time sensitive information, accurate only as of the date of this live broadcast, March 1st, 2022. Except as required by law, Establishment Labs undertakes no obligation to revise or otherwise update any statement to reflect events or circumstances after the date of this call. With that, it is my pleasure to turn the call over to our CEO, Juan Jose.
spk02: Thank you, Raj, and good morning, everyone. I hope everyone is healthy and continues to remain safe. Revenue in the fourth quarter of 2021 totaled $35.3 million, 31% increase over the fourth quarter of 2020. full-year 2021 revenue of $126.7 million grew 50% over 2020. Our singular focus on women's health, the meaningful innovation we are bringing to our markets, and a track record of over 11 years of excellent clinical and aesthetic outcomes with Motiva implants continues to be the key for our market share gains, and we expect those gains to continue. Most importantly, our innovation centered on women's health are aimed at creating new categories and markets into the future. We are providing portfolio guidance for 2022 in the range of $155 to $165 million. This outlook represents estimated growth of 22% to 30% over 2021. This guidance captures the high level of confidence we have in our ability to take share in our existing markets and the early contribution of new products and new geographies that we expect over the course of the year. We continue to see healthy underlying market demand in our taking market share in geographies around the world where our products are sold. While the pandemic continues to create some volatility, we are confident that our market share gains and strong results will continue. 2022 looks to be another strong year for ESTA, as our science-based and consumer-centric innovations transform and expand the markets for breast aesthetics and reconstruction. Raj will provide additional detail on our fourth quarter performance in 2022 Outlook in a moment. Before I turn the call over to him, I would like to highlight several recent events. Earlier this year, we crossed a significant milestone in our journey of improving women's health. With our two millionth Motiva implant delivered to the market, it took nine years from when we first commercialized Motiva to deliver one million implants. And now, just two years later, we passed two million. While crossing two million implants is a commercial accomplishment we celebrate, we are most proud that women around the world are placing their trust in us by choosing Motiva. And this is not a trust we take lightly. A guiding principle from the day we founded our company is to put women first in all of our efforts. To this end, we constantly aim to be closer to our ultimate consumers, the women who receive our products, so we can best understand their needs and to provide support on their journey in breast aesthetics and reconstruction. The embodiment of these efforts is the Women's Health Hub we recently established in Barcelona. This hub will house our direct-to-consumer marketing teams, our European sales leaders, as well as our patient advocacy efforts all in one location. Locating these teams in the same office and having them in Europe, where we have direct selling efforts with Joy and soon with Nia, allows us to develop programs and initiatives that best meet the needs of women. An early example of what we can accomplish is the Joy program we launched last year. This first-of-its-kind program provides women with our latest generation Motiva Ergonomics II implants, as well as several other unique features and benefits. The Ergonomics II platform offers improved mechanical and chemical properties with our unique super silicones, making them 45% softer and 23% more adaptable, all of which we believe will result in even greater patient satisfaction. We believe they are the best implants ever designed and developed. With improved ergonomic characteristics, these implants are changing the consumer experience by providing more comfort in tissue-like look and feel. Joy also offers the Motiva Women's Choice Program. This first-of-its-kind program allows women with joy to receive financial support from establishment labs should they choose to have their implants removed for any reason subject to the program terms. Part of this program, participating surgeons may agree not to charge any additional fees for this procedure. The strong early interest we are seeing for Joy is an indication of the value that women see in the program, and our early commercial efforts suggest that this can translate into higher realized value for surgeons and for our company. Programs and offerings like Joy are a demonstration of what we can achieve by being close to the final consumer. And the new hub we have established in Barcelona will allow us to push these efforts even further when we launch the new category of minimally invasive augmentation with MotivaMIA and as we expand into new markets and geographies. On our last conference call, we updated everyone that we had submitted the first module of our PMA to the FDA. This first module covers the chemical characterization and biocompatibility of Motiva implants. Our modular PMA submission is still proceeding on track. We remain in active discussion with the FDA and are ready to submit the second module in the second quarter. As a reminder, in August of last year, the aesthetic cohort passed a two-year mark, and we continue to track these patients with excellent follow-up. We also closed our revision reconstruction cohort last year and are on schedule to complete the remaining reconstruction cohort of the trial in the next couple of months. We will provide additional updates over the coming months on our progress towards launching our Motiva implants into the United States. In September, we held an event at the London Press Meeting, marking the official launch of our Motiva Flora Tissue Expander in Europe and other CE-marked countries. Flora has many advances over other commercially available tissue expanders, including a first-of-its-kind RFID-enabled port. which allows for MRI imaging with our artifacts during the time an expander is used after a mastectomy. By being non-magnetic, FLORA potentially opens new options for radiation oncology treatment during this stage of recovery. FLORA also features our cell-friendly smooth silk surface, and early users have noted improved patient comfort and healthier capsule formation with this unique tissue expander. Reconstruction surgeons understand the differentiation of the flora tissue expander, and we have already won several tenders in Europe. Adoption of flora will take time, but early efforts have been encouraging and add to our belief that we can help support women in their breast reconstruction journey. While we have high expectations for the share we can take with flora in the existing reconstruction market, flora is only the first step in our aesthetic breast recon initiatives. where establishment labs will offer tools and techniques that allow women to receive reconstructive surgeries that achieve the aesthetic ideals to which they aspire and work to democratize breast reconstruction worldwide. We look forward to sharing with you more on these efforts in the future. On MotivaMia, our minimally invasive breast enhancement procedure, we continue to perform new cases, as well as tracking the original 100-patient cohort we completed last April. We have 100% follow-up on this group of patients, and the outcomes continue to support our belief that this approach will transform breast aesthetics and significantly expand the market. According to our market research, this new category could grow to 5 billion, with approximately half of the opportunity coming from new patients that had not previously considered a breast augmentation. Regulatory clearance in Europe for the tools that are part of the Motiva MIA system are ongoing and should allow for a planned launch in the first half of 2022. Our clinical and commercial efforts in China are ongoing, and we continue to make progress in the regulatory process. Our plan remains to launch Motiva in this fast-growing market in the second half of 2022. I will now turn the call over to Raj to cover our financial results.
spk05: Thank you, Juan Jose. Total revenue for the quarter was $35.3 million, in line with our preannounced range of $35 to $35.5 million provided on January 10th. Reported revenue growth in the fourth quarter was 31%. Foreign currency changes reduced our fourth quarter revenue growth by approximately three percentage points. Direct sales were approximately 44% of this total, while distributor sales, which can fluctuate based on changes in inventory levels and the timing of reorders, made up the balance. From a regional perspective, sales in Europe comprised approximately 38% of global sales, Asia Pacific and Middle East was 24%, and Latin America made up the balance. Brazil, which is our single largest market globally, accounted for approximately 14.7% of total quarterly sales. Our reported gross profit in the fourth quarter was $24.2 million, or 68.6% of revenue, compared to $14.6 million, or 54.3% of revenue, for the same period in 2020. The change in gross margin was a result of the year-ago period being impacted by timing of certain one-time expenses related to inventory obsolescence and scrap, as well as improvements in production volumes and a return to more normalized geographic mix this year. The gross profit this quarter improved from the 67.6% reported in the third quarter of 2021. Average selling prices in the fourth quarter were down slightly from the third quarter of 2021. SG&A expenses for the fourth quarter increased approximately $9.4 million to $27.6 million compared to $18.2 million in the fourth quarter of 2020. The increase in SDNA in the fourth quarter resulted from a normalization of business practices following the disruption from the global pandemic. The fourth quarter also saw a resumption of some in-person medical meetings and congresses. We're also prioritizing marketing, spending, and new initiatives like Joey and Mia. R&D expenses for the fourth quarter increased approximately $1.6 million in the same quarter a year ago to $6 million. R&D expenses also returned to more normalized levels this quarter and will fluctuate quarter to quarter based on the timing of clinical trial and other expenses. Total operating expenses in the fourth quarter were $33.6 million, an increase of approximately $10.9 million from the year-ago period. The increase this period was, again, due primarily to the normalization of activity and spending levels relative to a year ago, as well as the aforementioned timing of research and development costs and investments in growth initiatives like Joey and Mia. Net loss from operations for the fourth quarter was $9.4 million compared to a net loss of $8 million in the year-ago period. Our cash position remained strong at $53.4 million as of December 31st, compared to $84.5 million at the end of the previous year. Cash used in the fourth quarter included approximately $2.9 million of investment in our new Sulyam Innovation Campus. On the capital front, we have signed a non-binding term sheet to refinance our existing credit facility. The new loan, which is subject to negotiation of definitive documentation, would replace our current loan with a larger debt facility at what we anticipate will be improved terms. This non-dilutive financing should allow us to fund our growth initiatives including the new Sulyam Innovation Campus that will allow us to produce more than half the world's implants and provide growth capital well past our U.S. launch. As Juan Jose noted earlier, we are providing sales guidance for 2022 of a range of $155 to $165 million, representing estimated annual growth of 22 to 30%. Overall, there is considerable momentum in our business. We are taking share globally, and we expect this will continue. In refining our outlook, we took several factors into consideration, including the uncertainty associated with the pandemic. The low end of our guidance range assumes COVID pressures will continue, while the high end assumes no significant new waves after the current one. In addition, this range does not contemplate any material supply chain disruptions throughout the year. We saw minimal impact on our results in 2021 as we managed our supply chain effectively, and we continue to monitor this situation closely. As we look down the rest of the P&L, we continue to expect to see spending levels increase as we prioritize investment in the significant number of development and commercialization programs we have underway. Preparing for entry into new markets and advancing our pipeline of new technologies to drive future growth remains a top priority. However, our revenue growth and strong gross margin should result in our operating expenses as a percentage of sales continuing to trend down even as we increase strategic investments. We believe our company is in a very strong competitive and financial position. And with that, I will turn the call back over to Juan Jose.
spk02: Thank you, Raj. 2021 was a foundational year for Establishment Labs. Among our accomplishments last year that have set the stage for many years of strong growth ahead are the completion of our 100-patient IRB study for Motivamia, The publication of the landmark study by Dr. Robert Langer and the group of researchers at MIT in nature biomedical engineering that provided strong scientific evidence of how our patented smooth silk surface is the most biocompatible among existing surface technologies. The groundbreaking on our new Sulayon Innovation Center that will more than double our manufacturing capacity and allows us to serve half the current global market. the unveiling of the ergonomics to platform and the launch of the joy program and our entry into breast reconstruction with the launch of the motiva flora tissue expander. What we have accomplished already is significant. But we are still at the beginning of our story, we are preparing for the next chapter in our growth story grounded solidly in our commitment to women's health and well being. It is within our reach to become not only the leading global company in breast aesthetics and reconstruction, but more importantly, over the next few years, we will continue to transform and expand our markets and create new categories in our space. We will continue to innovate in our core markets by getting closer to women in their aesthetic journey. We will enter the United States and China, the world's largest markets. we will work to improve awareness, access, and outcomes worldwide in breast reconstruction with our Aesthetic Breast Recon program. And we will launch Motivamia, opening up a new category and new customer base in breast aesthetics. I will now turn the call over to the operator for your questions.
spk09: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question is from Chris Cooley with Stephens. Please go ahead.
spk06: Good morning, and thank you for taking the questions, and congratulations on a super year in 2021. Juan Jose, if I may, just as we start, I'd like to focus on Motiva MIA and with commercialization, or I should say the early stages of commercialization in Europe upon us here this year in 2022. Could you help us think a little bit more about the nuances of this market, not only from the surgeon perspective, what skill set is required, how they're going to have to interact differently with the patient, but also in terms of how the company would approach doing this type of missionary sale, if you will, to this new market opportunity to bring these women into the pipeline? and kind of how that marketing message has to differ. And then I've got a quick follow-up on operating expenses. Thank you.
spk02: Thank you, Chris. And definitely Motiva EMEA is one of the most exciting things that is happening in aesthetics. And, you know, we are happy to be leading this, you know, transformation of the landscape in breast aesthetics with Motiva EMEA. And, you know, one of the most important things is what you had just mentioned. You know, we are bringing in a new customer base. And that new customer base requires different interactions. It's not the traditional breast augmentation patient. And I think one of the most important things that we have done lately is the opening of our Women's Health Hub in Europe. And what that does is it creates a lot of internal capabilities to be able to create that funnel to bring in those new customers. So we have in Barcelona now the firepower that is needed to be able to deliver on that promise. And we think that not only creating awareness, but having a very clearly defined funnel is going to make this very effective because we will be watching our customer acquisition costs very carefully. On the other hand, when it comes to surgeon education, remember during the last year, we trained several surgeons on how to do the procedure. And one of the things we found out is that actually it is much simpler surgery than traditional breast augmentation. It's a standardized procedure. It has standardized tools. So it actually makes it a lot easier for these surgeons to deliver, you know, on the MIA promise. So of course we will continue to expand our, you know, surgeon education, efforts so that we are prepared not only for the targeted launch, which will take place in a few cities in Europe in the first half of this year, and then in the second half of the year, as we expand it to more clinics, you know, we plan to have all the necessary surgeons trained on time.
spk06: Understood. Thank you so much for that, Connor. And then if I could, just for my follow-up, Raj, you provided impressive, you know, 22 to 30% organic top line growth guidance for the year off a 50% comp in 21. But kind of along the same vein, you know, this is truly kind of a transformational year, at least in our perspective, for establishment labs with Motiva MIA, the launch of Motiva in the U.S. and in China. So as well as, you know, just continuing to hopefully take shares. So could you help us think a little bit about timing of planned expenditures, how this may be a little bit different versus maybe prior years, just when we're thinking about the total OPEC spend, maybe from a kind of first half, second half perspective. Thanks so much.
spk05: Yeah, sure. Yeah, it's good to talk to you, Chris. You know, your question is a good one. Certainly, as Juan Jose was describing, right, what we're doing with MIA, you know, the launch of Joy, a lot of the new initiatives we have ongoing, you know, they do require investments. But as we noted in our prepared remarks, given the strong top-line growth, we do expect that our operating expenses as a percentage of revenue will trend down over time, and even in this year. In terms of the timing of expenses, certainly we are mindful of when we're committing to these things, and we will look at our expenses at a very tight level. I would expect in the first part of the year the expenses will be a little bit lower, and you'll see them build as the year goes on. but you should trust that we're very judicious about what we're spending on and we're going to do this in a very efficient way.
spk06: Thank you and congratulations.
spk09: Thank you. Our next question is from Zach Rayner with Jefferies. Please go ahead.
spk03: Hey, good morning. Thanks for taking the question. Congrats on another good quarter. I just want to focus on China. I know the launch is coming at the end of this year. Can you just talk, historically you size the market $150, $200 million. Can you just talk about the commercial strategy there and, you know, what a successful launch looks like maybe in terms of share or, you know, two, three years post-launch? Thanks.
spk02: Thank you, Zach. And, you know, we are very excited about, you know, coming into China with our Motiva implants because it is one of the fastest growing breast aesthetics markets in the world. It is the one with the highest average selling prices in the world. So that combination to us is one that we seek to exploit. And one of the things that we talk about often is our success in Asia and how fast we were to take a leadership position in South Korea, for instance. And the South Korean market kind of defines what happens in the Chinese market because they follow the same trends. And the South Korean plastic surgeons are doing most of the medical training for the Chinese plastic surgeons. And before the pandemic, about 25% of the patients for Motiva in South Korea came from China. So we already have some very good reference points of how well we can do in China. We have a strategy that is set with our partner, and our partner has been very good at using direct-to-market, direct-to-consumer strategies in South Korea, and we plan to use a similar strategy in China. We are planning for a launch by the end of the year, and we are working with our partner to be able to make that a reality.
spk03: Yeah, that's helpful. Thanks.
spk09: Thank you. Our next question is from Josh Jennings with Cohen. Please go ahead.
spk08: Hi. Good morning, Juan Jose and Raj. Thanks for taking the questions. I'm going to first start on 2022. I'm just thinking about the anniversary of Allergan or AbbVie pulling their smooth implants from most global markets. It's been 12 months now. You have the Shear Report, the Langer paper out there. And just with that jump ball share, I know every country is a different market, but do you feel that Motiva is, in 2022, is positioned or established in a position to capture even a higher percentage of that jump ball share that Allergan left on the table? And is that part of the assumption baked in, is that one assumption baked into the strong guidance you guys provided?
spk02: Yes, I think that, you know, when Allergan pulled there were implants from the world market outside of the United States that was mostly a textured market. So many of those customers at first went to another textured brand. And, you know, what we've been doing since then is continuing to ramp our efforts in terms of medical education to be able to teach a generation of plastic surgeons on how to use our implants effectively. And this is something that we continue to do. For instance, in Q4, you can see the results in Brazil where we have done extremely well with our medical education following the pullout of the mentor implants from that market. So, of course, we use that as an opportunity to teach all of these new accounts on how to use Motiva implants. And that's why we continue to gain market share in Brazil, but we also continue to gain market share you know, all over the world. But most importantly, what I think, Josh, 2022 does is that we go from just taking market share to real market expansion initiatives. And I think this is something that we will keep talking about more and more during the year. Excellent.
spk08: Just one follow-up on 2023. Actually, just quickly on 2022 again. I mean, that 22% to 30% guidance, that's inclusive of a currency headwind is our presumption. But can you talk about, Raj, what headwind is baked into that, that you're just absorbing within that 22% to 30%? Let me just have one follow-up on the 2023.
spk05: Sure. Yeah, when we look at the currency rates we've assumed for 2022, you know, relative to the average rates last year, you know, we're absorbing about a one percentage point headwind because of currency this year in those numbers.
spk08: Great. Thanks for laying that out. And then just thinking about 2023 as we're moving into 2022, I think the China launch and potentially the U.S. launch are going to be in play. Just wanted to ask about expectations and how we should be thinking about the U.S. launch. How can you prepare for that launch in front of approval? And, you know, we've seen the Flora launch in Europe and now the MIA launch. You know, there's a an early limited stage, and just wanted to kind of get an in front of expectation setting for how you see the rollout in the U.S. faring compared to some of the limited launches you experience in Europe, and just whether you can have a sales force build up in front of the launch and then go pedal to the metal, or is it going to take some time, as our assumption, to work through post-approval, getting regional sales members in place, and really attacking the plastic surge and Thanks for taking the questions.
spk02: Yeah, when it comes to the U.S. launch, of course, you know, this is a fundamental milestone for the company and one of the reasons we took this company public. And we have already begun preparing for our U.S. launch. We hired Dr. Heather Brennan to be our head of U.S. commercial operations. We're setting ourselves up for success by creating the infrastructure that is necessary, both in terms of systems and logistics, to be able to do what is necessary in this market. When it comes to hiring sales reps and MSLs and other type of personnel, of course, we'll be very judicious in not doing it in a way that affects our spending levels ahead of the launch.
spk08: Great. Thanks again.
spk09: Thank you. Our next question is from Matt Taylor with UBS. Please go ahead.
spk07: Good morning. Thank you for taking the question. The first one I wanted to ask was just on the materiality of some of the new product launches, you know, Flora, Mia, China this year. Is there a lot of revenue baked into the guidance? Could you just talk about how material those revenues are assumed or is this kind of a more gradual transition year and a ramp of those products in 2023?
spk02: Yeah, I think it's more of a gradual transition because when it comes to breast reconstruction, you know, we launched in the second half of last year and, you know, the growth there is basically done through the tender process in different regions in Europe. And that takes time. Sometimes these tenders take place only once a year or every two years. So the growth is basically gradual because of that. And when it comes to Joy, we already launched We are making sure that we get the program right. Remember, these products are sold at a significant premium from the current ergonomics implants. So we want to defend that premium and want to be able to train the surgeons on the features and benefits of these implants and also communicate to patients what those benefits are. And finally, I think with Mia, it's more of a year of making sure that we prove the expansion of that can take place by bringing new patients to these practices. So we're going to make sure that we get it right. And that's why, you know, in that guidance, what you see is a gradual growth of all those new initiatives.
spk07: Great, great. And then maybe I could just follow up with a question about U.S. timeline. So I heard on the prepared remarks, you said you're ready to submit the second module in the second quarter. Maybe just talk about any insights from back and forth that you've had with the FDA so far, and if that timeline holds, do you want to give us the best guess of when you could get approval? Is it reasonable to assume, you know, first half of 2023?
spk05: Yeah, on that, on your second question, I think we have, you know, we've purposely not kind of put a stake in the ground in terms of timing of approval, just given the uncertainty around, you know, timelines at the FDA, given everything that's going on. As we've said, though, we continue to make progress. We are in discussions with the FDA. The dialogue is active. As we mentioned in the prepared remarks, we are estimating the second module will go in in the second quarter. That timing could change, and we continue to be prepared to submit the module when the FDA is ready to review it. So it is a fluid situation, right? But we continue to be ready to give the FDA any information that they need. to allow the process to continue to move forward. But in terms of endorsing an absolute timeline, it's just difficult to do right now.
spk07: Okay, great. Thanks for the call.
spk09: Thank you. Our next question is from Marie Thibault with BTIG. Please go ahead.
spk01: Good morning, and thank you for taking the questions. I wanted to try to drill down a little bit more into the geographies. You've noted you're taking SHARE across several geographies. Wanted to hear which countries I think you're seeing the most new uptake in and also wanted to check in on how the Brazil recovery is going. It certainly sounds like it's recovered. And also what impacts we might expect from Russia this year, given some of the tensions around the war there.
spk05: Yeah, in terms of, you know, you might have caught in the prepared marks around, you know, the split between the various geographies. Latin America has continued to do very good for us as a region this year. That's frankly been driven a lot by Brazil and some of the competitive changes in that market. So certainly Brazil has been a standout in terms of growth for us this year. But generally, as you saw in the numbers, it was a good year overall. And pretty much most of the markets that we compete in, we continue to take share. But if you wanted to call out one in particular, I would focus on Brazil.
spk01: That's great. And any impact that we should expect from Russia? That's a key market.
spk05: You know, we do sell into Russia and Ukraine. You know, they are smaller markets for us. And of course, we're watching the situation closely there as everybody is. And we hope for a quick and peaceful resolution to what's happening there. I think it's too early to really call out whether it's going to be, you know, significant. But I would tell you as an overall outlook, A piece of our revenue, you know, those markets are relatively small, you know, sort of low, low single digits.
spk01: Okay. Very well understood. If I could ask another here on MIA, I wondered if you could get a little bit more granular with, you know, how many centers you might be expecting to start with in the launch and whether a lot of that training and sort of the focus might be happening there. in the area around Barcelona or whether you can call out any particular countries you're thinking about with that early launch. And thank you for taking the questions.
spk02: Thank you, Marie. We are still defining the cities and the list of countries for the launch in the European Union. But I can tell you we're going to make sure that we can prove in the cities the market expansion capabilities of Mayap. And to us, that is the most important one. What I can say as well is that this hub is about providing the capabilities to be able to measure how we can expand the market. And this is very, very important to us. You'll see us talking more and more about a set of numbers that can help you understand how this market expansion takes place. And after we do that first phase, we are going to expand to the main cities in Europe. And we do expect this to do this gradually, but if you think about the fact that a surgeon can do a procedure in less than 15 minutes and that the flow of patients is so efficient, then you don't really need that many centers to be able to get to numbers that are meaningful in revenue. Of course, we will continue to grow over the next few years, But I think that is one of the most important things. You don't need thousands and thousands of centers to be able to reach our revenue milestones.
spk01: Thank you so much.
spk09: Thank you. Our next question is from Amit Azen with Goldman Sachs. Please go ahead.
spk04: Hi, good morning. This is Phil on for a meet. Thanks for taking the question. A couple of follow-up items, if I could, from questions that have already been asked. The first one on the comment just now, Raj, Ukraine and Russia. I think you said low single digits. Was that as a percentage of total sales? And is that on a combined basis, just so we have an idea for sizing the potential negative impact?
spk05: Yeah, it's low, low single digits. So I think single digit kind of numbers. And that is on a combined basis between the two of them.
spk04: On a percentage of total sales?
spk05: Yes, exactly.
spk04: Okay. Okay, that's clear. Thanks very much. One follow-up item on Matt's question, you know, I think the first module went in just before the 3Q call. So I think if my math is right, we're already past kind of the traditional 90-day window. I just want to clarify that, you know, I would assume based on what we've heard over the last couple of years, the FDA timelines, uh, just have been pushed out in a number of instances, depending on which department you're dealing with. Is it fair to say that establishment is doing everything basically in a timely fashion and that nothing so far is concerning? It's just, you know, FDA, um, having a bit of kind of log jam on their end. Is that fair to say?
spk05: Yeah, I think that's a fair assumption. I mean, and it gets to the earlier question about endorsing timelines, right? So, you know, the FDA, you know, clearly there's a lot going on, right? And so, um, the dialogue remains active with them. As I noted, our expectation is that we will submit the next module in the second quarter, right? So that is based upon our interaction with them and how we're seeing things progressing. But really nothing that I would call out that is concerning or, you know, anything that's disrupting the timeline. It's, you know, these things just take time. And we're, again, as you noted, we're not, you know, we're providing the FDA with the information as they need it.
spk04: know so we don't want to be the party or any any reason that this gets held up in terms of it progressing uh very clear thank you again for that one just one more if i may i was interested if the i think the third module typically manufacturing module is there any implication around completion of your third facility in costa rica in conjunction with that submission or any potential you know How does that play out? Is there a relationship between completion of the third facility and the submission to the U.S. given the capacity that's going to be coming from that new facility? Thanks for taking the question.
spk05: Yeah, no, they're not linked at all. So the new facility that's under construction will have no bearing on the timing with the FDA.
spk02: Thanks again.
spk09: Thank you. There are no more questions at this time, and I will now turn the call back over to Juan Jose for closing remarks.
spk02: Thank you for joining us on today's call. We look forward to providing our next quarterly update in May, and we wish everyone continued good health, and we offer our prayers for peace in Ukraine.
spk09: Thank you. This concludes today's conference. You may now disconnect your lines. Thank you for your participation.
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