3/10/2022

speaker
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. To ask a question during the session, you'll need to press star, then 1 on your telephone keypad. Please be advised, today's conference may be recorded. If you require operator assistance during the call, please press star, then 0. I'd now like to hand the conference over to your host today, Colleen McMillan, Vice President, Communications. Please go ahead.

speaker
Colleen McMillan

Hello, everyone. We'd like to welcome you to today's call to discuss Lumiere DX's fourth quarter and full year 2021 financial results issued earlier this morning. With us are Lumiere DX's Chairman and CEO, Ron Zwanziger, Chief Financial Officer, Dorian LeBlanc, and Chief Product Officer, Pooja Patek. The press release announcing our financial results is posted on the investor relations section at the company's website at LumiraDX.com. Before we begin, I would like to caution listeners that any statements we 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 uncertainty and such as those detailed in our proxy statement and prospectus filed with the SEC on September 3, 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. We'll then provide financial and business updates before answering questions. Ron?

speaker
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 enable the shipment of more than 21,000 platforms through the end of 21 and approximately 4,000 more expected in this quarter. The success is being driven by the positive customer experience and clear competitive advantages of the NumeriDx 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 seven 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 Lumira DX 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 customer has come to understand both our platform and our R&D efforts, and has strong interest in the menu of diagnostic tests that can be performed on our platform. A second U.S. health system customer in the Midwest monitored our platform performance versus their lab PCR method for 12 months before implementing it in critical use cases such as pre-surgery testing. With this change, the customer was 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 tests are 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 with a D-dimer test, but an older rapid testing program had to be discontinued to a high rate of false positives and unnecessary hospitalization admissions. The Lumira DX D-diamond test provides lab-comparable results using a finger-sync sample and is being deployed successfully in GP offices in southern Sweden. We're 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 departments, as well as broaden the test menu with troponin and CRP. Finally, In Gloucestershire, 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 has reduced the burden of the healthcare system by triaging patients in community care settings before they arrive at the hospital or ambulatory services. Using one platform to support a number of tests, including COVID antigen, D-dimer, and CRP, has also streamlined resources and reduced costs to the Gloucestershire system. These 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 platforms. 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? Thanks, Ron.

speaker
Colleen

For the 12 months of 2021, Lumiere DX revenue was $421.4 million compared to 2020 full-year revenues of $139.2 million. We achieved $118.3 million in revenue in the fourth quarter of 2021. COVID antigen test strips on the Lemur DX 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 had 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-Limeridiaxone products had $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 in our Q3 earnings call, full-year margins in 2021 reflect the impact of more than $100 million of capital investments in manufacturing capacity made by Limerity X to rapidly scale operations. Our gross margins early in the year also include the negative impact of inventory scrap and lower initial production yields from our COVID antigen tests. and the fourth quarter of 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-Limeridx COVID testing supplies incurred a negative impact to gross margins of approximately 8 million as this inventory acquired early in the pandemic was sold at a loss in the fourth quarter to avoid expiring inventory and to meet Omicron-specific demand. Excluding the impact of these non-recurring 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 $130.2 million for the full year 2021. This represents an increase of 22% over the fourth quarter of 2020 and 21% compared to the 2020 full-year R&D costs 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 offsets to R&D spending in 2021 recognized as a 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 shared base 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 expenses 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 15 cents per fully diluted share. The net loss for 2021 was $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 68 cents for 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 1, 2027, unless earlier converted by the holders or repurchased or redeemed by Lemire DX. Initial conversion price of the notes is approximately $9.22 per share. In certain circumstances, Lemire DX will be permitted to redeem the notes with customary make-hold payments, as described in our recent 6K filings. In 2021, Limerity X spent more than $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 for 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 Lumiere DX 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. Slowdown in Omicron in the US 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 incidents 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, create 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 Limerity X 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?

speaker
Gross

Thanks, Dorian. Over the past year, our understanding of the platform has grown exponentially with the tests delivered to date. Whether it be working with different sample types such as nasal versus blood, different result 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 of 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 shipped 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 plan 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 marks for HbA1c, troponin, BNP, NP-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 case submission for INR, HbA1c, and strep A molecular. Combined with the current and planned COVID flu A, flu B, and RSV EUAs, 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, NP-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 510K submissions towards the end of this year or the first half of next year. Turning to COVID and COVID flu, we continue 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 test, which simultaneously detects and differentiates 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 a further product improvement to our current COVID-19 antigen test, which reduces the test time to just five minutes and potentially also provides 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 2-2. The adapted strip design may be applied to other respiratory products such as flu and RSV. We plan to submit the COVID test to FDA for both EUA and 510K 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 systems. In addition, through expanded authorization with Health Pulse at 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 Q2, 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 program. 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?

speaker
Operator

If you'd like to ask a question at this time, please press the star, then the number 1 key on your touch-tone telephone. To withdraw your question, press the pound key. Again, that is star, then 1 if you'd like to ask a question at this time. Our first question comes from Vijay Kumar with Evercore.

speaker
Vijay Kumar

Hi, 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?

speaker
Colleen

Thanks for the question. No supply chain constraints for us. We've actually been able to keep pace with all of our customer 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 kind of spilled between Q4 and Q1. So more of just a timing of the incidence in case counts and related testing volumes at customer's

speaker
Vijay Kumar

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.

speaker
Andrew Cooper

All right.

speaker
Colleen

So I think the path to profitability in 2022 you know, lead us to the question of, you know, 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, you know, continue to execute our core business strategy to populate the platform with a number of new product launches as Pooja's described. and drive fast revenue growth in the back half of 2022 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. Thank you. That's it for me.

speaker
Operator

Our next question comes from Jeffrey Cohen with Leidenberg Bauman.

speaker
Jeffrey Cohen

Hi, Ron, Dorian, and Pooja. How are you?

speaker
Ron Zwanziger

Good.

speaker
Jeffrey Cohen

Dorian, if you could start and talk to us a little bit about margins that look like a nice bump up in Q4 and how we should think about modeling that forward. I think we're thinking that near Q4 levels are sustainable for 2022.

speaker
Colleen

Any opinion there? If we look at overall enterprise margins, our core focus is on, on, on test strip margin. That's what's going to drive longterm value. And, you know, 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 scaling capabilities that we believe would be non-recurring. We also launched the COVID antigen test initially with only a very short shelf life. You know, that shelf life is now 13 months in all of our major markets. which makes managing between peaks in demand and troughs in demand as we've seen with the variants 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 strips 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 more 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 putting more through cost of sales than we might otherwise. We return to more reagent rental arrangements in the future. And the other piece in this quarter specifically was the one time related to the distribution business as a negative hit to margin and non-recurring. So I think you should see, as you said, 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%. Okay, got it.

speaker
Jeffrey Cohen

Could you give us an update on the Amira platform and production throughput and what you've seen there over the past number of months?

speaker
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 what we do have we'll have at least a hundred thousand available at launch and then we'll have to see how supply supply constraints work its way into the system okay thanks Ron as far as our 22 and you spoke about getting the platform up toward 25,000 units

speaker
Jeffrey Cohen

Geographically speaking, where should we expect the additional 4,000 that you referenced earlier as far as geographies or continents?

speaker
Ron Zwanziger

That 4,000 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-Diamond, and in particular the various tests that Pooja referred to, including A1C, intraponin, and antiproBNP, coming with, we expect, several summer launches. I think the majority of the units later in the year will be in Europe and Japan and elsewhere, although as we get into the fourth quarter, I think there'll probably be an increase in the U.S. as some of the U.S. tests come through as well.

speaker
Jeffrey Cohen

Got it. Thanks, Ron. And then lastly for us, I guess for Doran, if you could walk through current inventory levels and how you're thinking about that as far as revenues compared to inventories, and was that an intentional build over the past few quarters, and is that build mostly related to instruments or strips?

speaker
Colleen

Yeah, good question. It's obviously a year-on-year build. if you compare it to December of 2020, but it's actually been a decrease from September 30th to December 31st, 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 to match with the pace of revenue. As well, on the instrument side, we've built instrument component inventory as well, and that represents a large portion of the overall inventory, instruments and instrument accessories inventory. and so we'll use that inventory to continue to place instruments through the first half of this year.

speaker
Jeffrey Cohen

Perfect. Thanks for taking our questions. Appreciate it.

speaker
Operator

Our next question comes from Mark Massaro with BTIG.

speaker
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 win a very large deal you know, over a billion dollar contract from the DOD for at-home COVID antigen tests, I guess. I guess first, you know, Ron, were you 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 an entity outside the United States?

speaker
Ron Zwanziger

Well, I'd be surprised if there were any additional ones, simply because in most of the countries that tend to do large government contracts, the Omicron is waning. But who's to say what will happen if there's another variant? But I would have thought that in the short term, I would have thought it's unlikely. In fact, I wouldn't be surprised if the levels of inventory that various governments ordered are probably too high already.

speaker
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, you know, a lot of mask mandates are off. seems like more people are focused on Ukraine more than COVID. But can you just give us a sense for what type of step change, you know, as we're truing up our models for 2022, you know, consensus is modeling for a decrease year over year. But maybe just walk us through, you know, to what extent you're seeing, you know, I know you already kind of gave us the Q1 outlook to be similar to Q4. But as we think about the rest of the quarters, I mean, 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?

speaker
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, where the tests are used to ensure safety in hospitals or even in doctor's offices and other 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 of declines in others. But you're asking really an impossible question. And in our prepared remarks, we've specifically pointed out that it's just too hard to know. you know, what's going to happen with the travel industry. We've had requests to deal with the travel industry, to continue travel with the travel industry, and we've had others kind of not knowing what they should be doing. So the question you ask is really impossible to answer. So that's why we made the comment because of all these variables that we take a We ourselves, for our own planning purposes, take a very cautious view, although we're geared up and we can respond quickly, but we're taking a bit from an 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 flu A, flu B, CRB launch, as well as D-dimer. And that rate of product and launches, I think, will accelerate this year. On the commercial side, however, we didn't focus the folks on to 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 remained, even while technically we had switched, the commercial focus had remained on COVID and on 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 commercially up until now has remained on COVID.

speaker
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?

speaker
Ron Zwanziger

Well, I mean, initially, obviously, it remains high, and it was driven by the customers increasingly 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, but more importantly, it gets the results out and throughput out quickly. And so that drove customers, and we had 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 had developed a molecular technology for 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 Molecula. But because we developed the Fast Lab solutions 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're responding, and the Fast Lab business while initially it was a response to the pandemic is turning into a fast-lapse solution in its own right for customers.

speaker
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, You know, are you confident that you'll likely have it for, you know, Q4?

speaker
Ron Zwanziger

Well, I think so. We haven't seen anything that would indicate that, oh, we haven't had any issues that we don't think we can address. So, yes, I think we do think. Timing is always very hard to predict in Q4. in interacting with the agency, but we don't see anything that should mean that we shouldn't be able to get it. Okay, great. Although your question was a bit narrow in relation to the current season, you know that there really hasn't been much of a season, of course.

speaker
Mark Massaro

Yep, fair point. Okay, thank you.

speaker
Operator

Our next question comes from Andrew Cooper with Raymond James.

speaker
Andrew Cooper

Great. Thanks for the questions, everybody. Lots to ask. 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?

speaker
Gross

Right now, we're moving forward with the full plan. Andrew, so the timing is a little bit just related to how quickly the clinicals can get done and some of the changes in the CE certification process.

speaker
Andrew Cooper

Okay. And on those trials, I mean, do you need to go out and find new sites to participate? Do you have the install base out there that you can sort of go to those customers that already are used to using the instrument and say, hey, would you like to participate? Just what is that pathway going to look like? Have you already recruited them? Where are we for maybe the nearest term of the

speaker
Gross

Yes, we have a clear path for the clinicals. For CE-MARC, there's also an opportunity to do a lot of retrospective clinical work, so we can leverage that. So, yeah, we have a clear planning path to CE-MARC, NT-PRO, BNP, troponin, A1C, and then BNP and sodium potassium. Okay, this year.

speaker
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 potentials.

speaker
Andrew Cooper

Okay, great. And maybe just on fast lab, on the recent question from Mark, when we think back to really when the stock was first coming public, I guess, the D-SPAC 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 for those sorts of solutions changed? How big do you think that business can be in that time frame? Any change from what you communicated prior?

speaker
Ron Zwanziger

Well, that's a 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 hit a real interest level amongst customers everywhere. customers pretty much everywhere are asking us or telling us what they would like to see in terms of different tests because they've sort of experienced firsthand how it's changed their workflow in their laboratories. So, yeah, I think you're right. I think it could be larger.

speaker
Andrew Cooper

Okay, great. I'll stop there. Thanks for the question.

speaker
Operator

That concludes today's question and answer session. I'd like to turn the call back to Ron Sponziger for closing remarks.

speaker
Ron Zwanziger

So in closing, I'd like to reinforce that we are 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 of this micro affiliate 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 our long term strategy and drive revenue growth for years to come and we expect to see a 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. Thanks very much. Have a good day.

speaker
Operator

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

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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