Earnings Transcript for LMDX - Q4 Fiscal Year 2021

Operator: Good day and thank you for standing by. Welcome to the LumiraDx Fourth Quarter 2021 Earnings Call. At this time, all participant lines are in listen-only mode. After the presentation, there will be a Question and Answer session. [Operator Instructions]. Please be advised, today's conference may be recorded. [Operator Instructions]. I'd now like to hand the conference over to your host today, Colleen McMillen, Vice President Communications. Please, go ahead.

Colleen McMillen: Hello, everyone. We'd like to welcome you to today's call to discuss LumiraDx's, Fourth Quarter and Full-Year 2021 Financial Results issued earlier this morning. With us are LumiraDx’s Chairman and CEO, Ron Zwanziger, Chief Financial Officer. Dorian LeBlanc, and Chief Product Officer, Pooja Pathak. The press release announcing our financial results is posted on the Investor Relations section of the company's website at LumiraDx.com. Before we begin, I would like to caution listeners that any statements you make today other than historical facts are forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Please be aware that all such forward-looking statements involve risk and uncertainties, such as those detailed in our proxy statements and prospectus filed with the SEC on September 3rd, 2021 and other filings with the SEC. Any forward-looking statements that we make must be considered in light of these factors. Actual results may vary materially. Also during the course of today's call, we may refer to certain non-IFRS financial measures. There is a reconciliation schedule showing the IFRS versus non-IFRS results currently available in our press release issued earlier today, which can be found on our website at lumiradx.com. I will now turn the call over to Ron Zwanziger for opening remarks, who will then provide financial and business updates before answering questions, Ron.

Ron Zwanziger: Thank you, Colleen, and thank you all for joining the call today. Our company delivered a strong quarter and a year of progress and we're just getting started on our journey of transforming community based care. We're providing fast, accurate and comprehensive diagnostic information to healthcare providers to make point-of-care diagnostics affordable and accessible for every individual in the world. Our next-generation Platform is proving its value and impact with a wide range of customers. The fourth-quarter and full-year’21 numbers underscore our tremendous growth potential. More broadly, the pandemic has accelerated our vision and deployment of our next-generation platform and enabled a shipment of more than 21,000 platforms through the end of’21, and approximately 4,000 more expected in this quarter. This success has been driven by the positive customer experience and clear competitive advantages of the LumiraDx Solutions compared both to legacy point of care diagnostics and Central Lab Solutions. We currently have eight tests in the market and our microfluidic technology and platform have been proven to meet the market needs for fast high sensitivity, convenient, and connected diagnostic test results; for health systems, emergency rooms, retail pharmacy chains, and other community settings. Let me give you a few case studies of the impact of our platform with major customers. At One West Coast U.S. Health System customer, the platform installed base grew from 7 in the first quarter of’21, to 337 this year, as their confidence increased about the speed, accuracy, and sensitivity of our Rapid Antigen COVID testing with the LumiraDx microfluidic technology. What's notable is that they expanded the use cases throughout the year, starting with initial focus on physician office labs. And then, replacing point-of-care molecular systems for urgent care, pharmacy, hospital labs, and surgery. As we deepen the partnership, this customers come to understand both our platform and our R&D efforts and has strong interest in the menu of diagnostic techs, as they can be performed on our platform. A second U.S. health system customer in the Midwest, monitored our platform performance versus their lab PCR metric for 12 months, before implementing it in clinical use cases such as pre -surgery testing. With this change, customers are able to substantially improve turnaround times for pre -surgery patients. I'd also like to highlight how our platform is being used for other conditions besides COVID. In Sweden, our D-Dimer test, changing the standard of care for aiding in the diagnosis of deep vein thrombosis and pulmonary embolism. These conditions are a leading cause of death, and may be ruled out the D-Dimer test. But an older rapid testing program had to be discontinued to a high rate false positives and unnecessary hospitalization admissions. The LumiraDx D-Dimer test provides lab comparable results using a fingerstick blood sample and is being deployed successfully in G office -- GP offices in Southern Sweden. We are now exploring opportunities to leverage the portability, digital results, and data connectivity of our solution to enable additional use cases, such as mobile teams, ambulances, and emergency department, as well as broaden the test menu with troponin and CRP. Finally, in Gloucester, England, LumiraDx was brought in as a single integrated point-of-care solution across the health system, bridging primary and secondary care. The LumiraDx Platform implementation as we reduce the burden of the healthcare system by triaging patients in community care settings before they arrive at the hospital in that or ambulatory services using one platform to support a number of tests, including COVID antigen, D-Dimer, and CRP. There's also streamlined resources and reduce cost to the Gloucester system. The customer case studies should give you a sense of the growing validation by healthcare providers and resulting market adoption and the use cases for our platform. This and the opportunities for our Fast Lab Solutions will be critical factors for our growth this year, even as we meet the customer needs for COVID testing and navigate the unpredictability of the coronavirus. At the same time, we remain focused on delivering very significant non-COVID revenues over the next several years. We're pursuing long-term growth in the $50 billion addressable market for our platform by transforming point-of-care diagnostics, and making progress in our pipeline of 30 plus diagnostic tests for common health conditions including infectious diseases, cardiovascular disease, diabetes, and coagulation disorders. I will now hand things over to Dorian to go into our financial performance. Dorian.

Dorian LeBlanc: Thanks, Ron. For the 12 months of 2021, LumiraDx revenue was $421.4 million compared to 2020 full-year revenues of a $139.2 million, we achieved $118.3 million in revenue in the fourth quarter of 2021, COVID Antigen test strips from the LumiraDx Platform contributed $75 million and Fast Lab Solutions delivered Q4 revenue of $23.7 million. As we continue to see adoption of our unique molecular chemistry with new customers. The Omicron variant at a significant impact late in the fourth quarter and that impact continued into the first quarter of 2022. Our third-party distribution activity for non - LumiraDx ome products at $14.9 million in revenue, including approximately $9 million in sales of COVID-related testing supplies. Total gross margins for 2021 were 36% compared to 38% in full-year 2020. For the fourth quarter of 2021, gross margin improved to 46.1%, compared to Q3 2021 gross margins of 35.6%. As discussed during our Q3 earnings call, full-year margins in 2021, [Indiscernible] the impact of more than a $100 million of capital investments in manufacturing capacity made by LumiraDx to rapidly scale operations. Our gross margins early in the year also included the negative impact of inventory scrap and lower initial production yields from our COVID antigen tests. In the fourth quarter, those issues were not recurring and our test strip margins exceeded 80%. Instruments placed free of charge were expensed directly to cost of sales and will continue to negatively impact gross margins. The previously noted distribution business revenues associated with non-linearity X COVID testing supplies incurred a negative impact to gross margins of approximately eight million as this inventory acquired earlier in the pandemic was sold at a loss in the fourth quarter to avoid expiring inventory and to meet Omicron's specific demand. Excluding the impact of these nonrecurring distribution business revenues, total gross margin in the fourth quarter would have been 53.7% Research and development costs were $33.8 million in the fourth quarter, and a $130.2 million for the full year of 2021. This represents an increase of 22% over the fourth quarter of 2020, and 21% compared to the 2020 full-year R&D cost, as we continue to increase capabilities, opened our new R&D center in Glasgow, and further resourced our development teams for continued pipeline delivery. Fourth quarter R&D expenses benefited from the recognition of $8.7 million of grant funding and other R&D incentives, including a change in our R&D tax credit program in the United Kingdom that resulted in R&D offsets in operating expenses versus prior year tax credits that were accounted for as an income tax benefit. Total offset to R&D spending in 2021, recognizes that reduction in R&D expenses were $13 million, compared to $1.5 million in 2020. Fourth quarter sales marketing and administrative expenses were $37.4 million and full year 2021 sales marketing administrative expenses were $130.5 million. Reported R&D and SG&A expenses include $5.3 million of amortization and share-based payment expenses in the fourth quarter of 2021, and $36.6 million in the full year. In addition, we incurred listing expenses related to our SPAC merger of $5.4 million in the fourth quarter and $36.2 million for the full year 2021. Excluding amortization, share-based payment expense, and listing related charges, the non-IFRS adjusted operating loss for the fourth quarter was $11.4 million. And for the full-year 2021, was $72.6 million. Net loss for the fourth quarter of 2021, was $37.2 million or $0.15 per fully diluted share. The Net loss for 2021, was a $100.8 million or $0.62 per fully diluted share. Our non-IFRS adjusted net losses for the fourth quarter of 2021, and the full-year 2021, excluding merger expenses and excluding amortization, share-based payment expenses, unrealized foreign exchange gains, and other non-cash financing items, were $20 million or $0.08 per fully diluted share. And $111.6 million or $0.68 per fully diluted share, respectively. At December 31, 2021, we had $300 million in senior debt and $18 million in other term debt. Our cash balance on December 31st, 2021, was $132.1 million. On March 3rd, we closed the issuance of $56.5 million of our 6% convertible senior subordinated notes. The notes will mature on March first 2027, unless earlier converted by the holders, or repurchased or redeemed by LumiraDx. Initial conversion price of the notes is approximately $9.22 per share. In certain circumstances, the LumiraDx will be permitted to redeem the notes with customer, and make whole payments as described in our recent 6-K file. In 2021, LumiraDx spent more than a $100 million in capital expenditures, and rapidly transformed our operations to deliver tens of millions of diagnostic test strips, with an industry-leading cost position and laboratory equivalent performance at the point-of-care. We anticipate capital expenditures to be only 25% of our 2021 spending, or 2022, as the majority of the manufacturing expansion activities have already been paid for in 2021. For 2022, we experienced a strong start to the year, and expect Q1 revenues to track similar to our Q4 2021 revenues. In addition, we expect total LumiraDx instrument shipments to grow to more than 25,000 instruments exiting the quarter. However, COVID revenues for the balance of the year are impossible to model. The slowdown in omicron in the U.S. and some other countries already, a lack of visibility on the length of time testing will be needed for travel or by employers, the level of residual and incidence of COVID, the range of possible political decisions, the variability of these issues between countries, and the overall vaccination rates, as well as the acceptance of boosters, creating an environment that causes us to be more conservative on expected COVID revenues for the balance of the year. We do however, anticipate strong revenue contribution from non-COVID assays in late 2022. With our manufacturing capabilities, our growing installed base of LumiraDx instruments with high-quality, long-term, point-of-care customers, and our near-term pipeline that consists of most of the largest opportunities at point of care, we are positioned for significant long-term growth. We remain focused on transforming community-based healthcare by delivering innovative diagnostics with lab comparable performance on a single platform. Pooja will now provide some exciting updates on our pipeline and product progress. Pooja?

Pooja Pathak: Over the past year our understanding of the platform has grown exponentially with a test delivered to date, whether it be working with different sample types such as nasal versus bloods; different results types such as qualitative versus quantitative, or different technology types such as enzyme versus Immunoassay. The platform technology has now matured in a way to enable the speed and scale of our product pipeline. The continued high performance at our test portfolio, supply capabilities, and expanding product menu drove market adoption and strong growth of our customer install base last year. Of the 21,000 instruments shift across 98 countries, 17,000 are in community care settings such as the physician office, pharmacy, Hospital and global health settings that will have utility for broader respiratory infectious disease, coagulation, cardiovascular and diabetes testing, more than half of these instruments are outside the U.S. We now have eight platform tests on the market and are making significant progress in our pipeline and overall plans for delivering a broad menu of lab comparable tests on a single point-of-care platform. Here are the latest updates. For Europe in January, we achieved CE Mark and began shipment of our CRP test, which provides quantitative results from a finger-stick sample in four minutes. In 2022, we also plan to achieve CE Mark for HbA1c, Troponin, BNP, NT-proBNP and sodium potassium with several commercial launches expected during the summer of this year. In the U.S., we plan this year to complete development and FDA 510(k) submission for INR, HbA1c, and Strep A. Molecular. Combined with the current implant COVID Flu A, Flu B, and RSV [Indiscernible], we will be able to provide our U.S. physician office and pharmacy customers a single point-of-care platform that replaces three separate instruments and workflows. For the hospital emergency department segment, our initial pipeline focus is troponin, BNP, NT-proBNP, and D-Dimer. And clinically as well as operationally, these tests have overlapping pathways and go well together. Our plan is to initiate clinical studies for these cardiac tests later this year and expect to complete FDA 510(k) submissions towards the end of this year or the first half of next year. Turning to COVID and COVID flu, we continued to deliver strong momentum with several important product launches and updates since our last quarterly call. For the point-of-care platform, in December, we achieved CE Mark for our COVID and flu antigen tests, which simultaneously detect and differentiate between COVID Flu A and Flu B in 12 minutes. We began product shipments in January. In the U.S., the test is still under FDA EUA review. We also continue to drive pipeline innovation in response to customer and public health needs for fast, accurate COVID screening in a variety of care and community settings. We have in development of further product improvements to our current COVID-19 antigen test, which reduces the test time to just five minutes and potentially also provide higher sensitivity. We believe the improvements in speed and performance will take point-of-care testing to the next level in physician offices, retail, and other community care settings, and we're moving fast to commercialize this product in Q2. The adapted strip design may be applied to other respiratory products such as flu and RSV. We plan to submit the COVID tests to FDA for both EUA and 510(k) authorization. Prospective clinical studies for COVID and flu, as well as COVID and RSV combination tests are ongoing. However, recruitment has been impacted by low circulating virus. The COVID and flu test has already been submitted to FDA for EUA review based on retrospective samples collected during the 2019 to 2020 flu season. Turning to Fast Lab Solutions, in December, we achieved several FDA EUA updates for RNA STAR complete molecular reagents, including asymptomatic testing, pooling of up to five individuals, and access to 384 well configuration on validated open RT-PCR system. In addition, through expanded authorization with HealthPulse@home, we are now able to offer sample collection at home and elsewhere, increasing access to molecular testing. Last month, we also achieved MHRA authorization for RNA STAR complete, enabling us to fulfill customer demand in the UK for high throughput, high sensitivity, and high efficiency testing, at events, schools, airports, and other public venues. Looking ahead, the Fast Lab R&D teams continue to innovate the qStar technology, including the addition of multiplexing to allow for simultaneous detection of multiple targets in a single reaction well. In’22, we expect to submit a multiplex respiratory panel to the FDA for an EUA, while adding more European - centric molecular lab offerings mid-year. Beyond the lab, we believe this technology has significant implications for our forthcoming point-of-care molecular programs. And one final update for Amira. We are still on track to initiate clinical studies by the end of this quarter. With that, we would be happy to take your questions. Operator.

Operator: [Operators instructions] Our first question comes from Vijay Kumar with Evercore.

KevinGenirs: This is Kevin on for Vijay. Looking at 4Q Antigen revenues of $75 million down quarter-on-quarter. Were there any supply chain constraints that impacted 4Q?

Dorian LeBlanc: Hey, Kevin, thanks for the question. No supply chain constraints for us. We've actually been able to keep pace with all of our custom orders for our installed base for COVID Antigen and have the manufacturing capacity to continue to do that. The real comparable really just relates to the timing of the peak of Delta versus the timing of the peak of Omicron, where Delta was fairly well contained within Q3 and Omicron spilled between Q4 and Q1. So more of just a timing of the incidence in case counts and related testing volumes and customers.

Kevin Genirs: Thank you. And looking towards 2022, what are your investment priorities and how should we think about operating leverage and the path to profitability? Thank you.

Ron Zwanziger: Dorian.

Dorian LeBlanc: So I think the path to profitability -- path to profitability in 2022 lead us to the question of where we expect COVID revenues to be for the balance of the year which obviously has driven margin for us across 2021 and as we said, that's really not possible for us to model. So the focus really is on continuing to execute our core business strategy to populate the platform with a number of new product launches as Pooja as described, and drive faster revenue growth in the back half’22 into 2023. We've got great opportunities to continue to grow this business at significant scale and significant pace and our focus will be on growth.

Kevin Genirs: Thank you. That's it for me.

Operator: Our next question comes from Jeffrey Cohen with Ladenburg Thalmann.

Jeffrey Cohen: Hi, Ron, Dorian, and Pooja, how are you?

Ron Zwanziger: Good?

Jeffrey Cohen: Dorian, if you could start and talk to us a little bit about margins, it looked like a nice bump up in Q4 and we should think about modeling that forward. And I think, we're thinking that your Q4 levels are sustainable for’22. Any opinion there?

Dorian LeBlanc: So if we look at overall enterprise margins, our core focus is on test strip margin. That's what's going to drive long-term value. And I think exactly as you said, we saw a nice step-up in there, as we mentioned, the Q3 call, we had some items related specifically to scale and capabilities that we believe would be non-recurring. We also launched the COVID Antigen test initially with only a very short shelf life, that shelf life's now 13 months in all of our major markets, which makes it managing between peaks and demand, in troughs in demand as we've seen with the variance, easier for us to do without worrying about inventory scrap. So a lot of those issues are behind us and that was reflected in the Q4 margins. But the other components to margin, as you know well in this industry, a lot of instruments are placed under reagent rental agreements where the customer's not paying for the capital, but agreeing to do purchases of test trips over a period of time. That can get accounted for differently depending on the exact customer arrangement. So in some cases, that's going to be a direct hit to cost of sales as a period charge. In other cases, it's going to be capitalized and spread over time. And so we'll try to point that out for you so you can understand the impact that's having on margin from quarter-to-quarter. But that certainly is going to -- in the near-term where one of our arrangements right now are placing instruments directly without reagent rental agreements. It's hard to commit customers to long-term purchases on COVID only. So we're purchasing -- we're putting more through cost of sales than we might otherwise -- we'll return to more reagent rental arrangements in the future. And the other piece was the -- in this quarter specifically was the one-time related to the distribution business as the negative hit to margin and non-recurring. So I think you should see, as you said the -- able to sustain continuing growing gross margins and really operating already with test strip margins that align with our long-term guidance of total enterprise margins over 65%.

Jeffrey Cohen: Okay got it. Could you give us some update on the Amira platform and production throughput and what you've seen there over the past number of months?

Ron Zwanziger: Well, Amira, we're expecting to -- as we say get the clinical trials underway. The product performance is excellent and all being well, we'll be able to launch the product relatively soon. We continue, as we've said before, have supply problems. But we do have -- we'll have at least a 100,000 available at launch and then we'll have to see how supply constraints work its way into the system.

Jeffrey Cohen: Okay. Thanks, Ron. As far as’22, and you spoke about getting the platform up towards 25,000 units. Geographically speaking, where should we expect the additional 4,000 that you referenced earlier as far as geographies, your continents?

Ron Zwanziger: That 4,000 was just in that was just in Q1, the quarter we're in. And those were disproportionately in the U.S. But as the year progresses because of the CRP launch in Europe and the acceleration of the D-Dimer, and in particular, the various tests that Pooja referred to, including A1C in Japan, and then, the [Indiscernible] B, coming in with we expect some -- several summer launches. I think, the majority of the units later in the year will be in European, Japan. and elsewhere. Although, as we get into the fourth quarter, I think, there will probably be an increase in the U.S. as some of the U.S. tests come through as well.

Jeffrey Cohen: Got it. Thanks. And then, lastly, for Dorian. If you could walk through current inventory levels and how you're thinking about that as far as revenues compared to inventories. And is that an intentional build over the past few quarters? And does that bode mostly related to instruments or strips?

Dorian LeBlanc: Good question. Obviously, a year-on-year build, and if you compare it to December of 2020, but it's actually been a decrease from September 30 to December 31, which is really reflective of Omicron bringing down inventories late in the year. And we expect that inventories will continue to decline here through Q1. And that's been intentional. We obviously built inventory at the beginning of the year at the height of the pandemic. And now we have the opportunity to bring down inventory levels as -- to match with the pace of revenue. As well on the instrument side, we built instruments, some component inventory as well. And that represents a large portion of the overall inventory instruments and instrument accessories. And so we'll use that inventory to continue to place instruments through the first half of this year.

Jeffrey Cohen: Perfect. Thanks for taking our questions. Appreciate it.

Operator: Our next question comes from Mark Massaro with BTIG.

Mark Massaro: Hey guys, thanks for taking the question. I guess, maybe I was a little surprised to see a vendor by the name of iHealth when a very large over a $1 billion contract from the DOD (ph) for at-home COVID antigen tests. I guess. I guess first Ron, really surprised to see that, and then second, do you expect to see any other large or meaningfully significant contracts awarded either from a U.S. entity or entity outside the United States?

Ron Zwanziger: What I'd be surprised if there were any additional one simply because in most of the most of the countries that tend to do launch government contracts, the Omicron is waning, but who's to say what will happen if there's another variants as another variant, but I would assort, I would've thought that in the short-term. I would've thought that some likely. In fact, I wouldn't be surprised if the levels of inventory the various governments ordered are probably too high already.

Mark Massaro: Right. And maybe can you guys just speak to -- or I don't know if you can quantify it or even qualitatively talk about what you're seeing right now with COVID antigen test demand. I mean, a lot of mask mandates are off. Seems like more people are focused on Ukraine war than COVID. But can you just give us a sense for what type of step change as we're truing up our models for 2022, consensus is modeling for a decrease year-over-year. But maybe just walk us through to what extent you're seeing. I know you already kind of gave us the Q1 outlook for -- to be similar to Q4. But as we think about the rest of the quarters, it does seem like COVID should decline at a fairly significant level on a year-over-year basis. So just walk us through what you're seeing, whether it's at a CVS MinuteClinic over in England or even at other clinical sites here in the U.S. What are you seeing right now in terms of ordering behavior?

Ron Zwanziger: We're clearly seeing a decrease. Pretty much mirrors the incidence levels around in some countries. On the other hand, in some accounts where the product is over the test to use to ensure safety in hospitals or even in doctor's office is not similar situations where the issue is to keep the emergency rooms functioning. Clearly that testing has to continue. And so we're seeing declines in some situations and not too much defines and other, but when you're asking really an impossible question. And in our prepared remarks, we specifically pointed out that it's just too hard to -- it's too hard to -- to know what's going to happen with the travel industry. We've had requests to deal with the travel industry to continue travel within the travel industry. And we've had others kind of not knowing what they should be doing. So -- so sort of question you're asking is really -- is really possible to impossible to answer. So we made the comment because of all these -- because of all these variables that we take a -- we ourselves for our own planning purposes, take a -- take a very cautious view. Although we -- although we're geared up and we can respond quickly, but we're taking a bit -- from operational standpoint, I mean. But we're taking a very cautious approach. And the whole company focus has switched from a technology standpoint, we switched last April a year ago, and that manifested itself in the -- through [Indiscernible] launch, as well as D-Dimer, and that rate of products and launches I think will accelerate this year. On the commercial side, however, we didn't focus the focus onto anything other than COVID and are only beginning to do it now, as in those geographies where Omicron is coming down. But even up to very recently, all the focus has been and remains, even while technically we had switched, the commercial focus had remained on COVID and on the other tests only to the extent of making sure that we get key opinion leaders, make sure we have some demonstration customers, make sure the product is getting initial acceptance. But the focus mostly up until now has remained on COVID.

Mark Massaro: Okay. Great. That's helpful. It looks like Fast Lab Solutions more than doubled sequentially. What drove that strong performance in Q4 and I guess how should we think about that run rate into 2022?

Ron Zwanziger: Well, I mean, initially, obviously, it remains high and it was driven by the customers increasingly recognize -- recognizing the utility of getting a very fast, reliable molecular result from their existing equipment. And it allows customers very efficient workflow within their laboratories were more importantly, it gets the results out and throughput out quickly. And so that drove customers and we had a quite a surge in new laboratories using the product. And interestingly, of course, we only developed last lab, you may remember, as a response to the pandemic. We are developing molecular technology for the platform, which is what we're doing and we expect to have some real success on the platform this year -- on the base platform this year, on molecular. But the -- but because we did -- but because we deal out the Fast Lab Solutions for to be helpful in the pandemic, customers are actually wanting it as a permanent feature and we have all kinds of customer discussions about what they want, and we are responding and the Fast Lab business small initially was a response to the pandemic is turning into a Fast Lab Solutions in term -- its own right for customers.

Mark Massaro: Okay, last question for me. I know you submitted your covid flu for EUA authorization. Are you still optimistic you can get that this month or so in time for this year's U.S. flu season? And if not, are you confident that you'll likely have it for Q4?

Ron Zwanziger: Well, thanks. So we haven't seen anything that would indicate that -- or we haven't had any issues that we don't think we can address. So yes, so I think we do think timing is always very hard to predict in interacting with the agency, but we don't see anything that should mean -- that we shouldn't -- we shouldn't be able to get it.

Mark Massaro: Okay. Great. Thanks, guys.

Ron Zwanziger: Question. Although -- although your question was a bit narrow in relation to the current season, there really hasn't been much of the season, of course.

Mark Massaro: Yeah. Fair point. Okay. Thank you.

Operator: Our next question comes from Andrew Cooper with Raymond James.

Andrew Cooper: Great. Thanks for the questions everybody. Go out and ask to absolutely. Maybe to start just when we think about Pooja what you said in terms of some of the launches coming this summer for CE Mark, can you give us a better sense for which ones might be summer, which ones might stretch a little bit later in the year.

Pooja Pathak: Right now, we're moving forward with the full plan, Andy, so that the timing is a little bit related to how quickly the clinical can get done and some of the changes in the CE certification process.

Andrew Cooper: Okay. And on those trials, do you need to go out and find new site to participate? Do you have the installed base out there so that you can go to those customers that already are used to using the instrument, and say, hey, would you like to participate? Just what does that pathway going to look? Have you already recruited them? Where are we for the nearest time of the trials?

Pooja Pathak: Yes. We have a clear path for the clinicals for to CE Mark. There's also an opportunity to do a lot of retrospective clinical work, but we can elaborate that. Yeah. We have a clear planning path to CE Mark. NP - proBNP, troponin, A1C, and then, BNP and Sodium potassium. This year.

Ron Zwanziger: We have -- Andrew, we have very large sample banks that we've been building up over time to help accelerate as we get into returns.

Andrew Cooper: Okay, great. And just on Fast Lab on the recent question for Mark, when you think back when the stock was first coming public, I guess the leaseback process, when you think about that 2024 target, you had talked about, I think about $50 million of Fast Lab revenues. Has what you heard from customers in terms of durable demand beyond COVID, where there's sorts of solutions changed. How big you think that business can be in that timeframe, just any change from what you communicated prior.

Mark Massaro: Well, that's very good question. It looks as if it could be with investment in R&D could be considerably larger than what we had originally contemplated. It's really a real interest level amongst customers everywhere. And customers pretty much everywhere are asking us or telling us what they would what they would like to see in terms of different tests because they sort of experienced first hand how it's changed their workflow in the laboratories. So yes, I think you're right and it could be larger. Okay, great. I'll stop there. Thanks for the questions.

Operator: That concludes today's question-and-answer session. I would like to turn the call back to Ron Zwanziger for closing remarks.

Ron Zwanziger: So in closing, I would like to reinforce that we're really just at the beginning of our journey to transform point of care diagnostics. Since the beginning of last year, we added six tests to our menu, so we're now at eight. And we've learned considerably about our own technology, given that the technology, this microfluidic platform is so noble. And our experience with it is such that the rate of pace of launching additional tests has now started to increase as a consequence, helping us to execute on our long-term strategy and write -- drive revenue growth through years to come, and we expect to see significant impact of this growth as we come towards the end of even this year. We'd like to thank you again for your questions and for joining the call today. Thank's very much, Have a good day.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.