LumiraDx Ltd (LMDX) 2021 Q3 法說會逐字稿

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  • Operator

  • Good day, everyone. Thank you for standing by, and welcome to the LumiraDx Third Quarter 2021 Earnings Conference Call. (Operator Instructions)

  • I will now hand the conference over to Colleen McMillen, Vice President of Communications. Please go ahead.

  • Colleen McMillen - VP of Communications

  • Hello, everyone. We'd like to welcome you to today's call to discuss LumiraDx's third quarter financial results issues 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 third quarter 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 risks and uncertainties such as those detailed in our proxy statement and prospectus filed with the SEC on September 10, 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 Q3 financial and business updates before answering questions. Ron?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Yes. Thanks, Colleen, and thank you all for joining our call today. We've been working to build LumiraDx for 7 years now with a vision of transforming community-based care by providing fast, accurate and comprehensive diagnostic information to health care providers at the point of need.

  • Our next-generation diagnostic testing solutions is designed to be affordable and accessible for every individual around the world. COVID exposed a further need for point-of-care testing with lab comparable results in minutes. Our microfluidic technology and platform have proven to meet the market needs for fast, high sensitivity, convenient and connected diagnostic test results.

  • We have successfully gone into the market with customers and partners, including CVS, the U.K. National Health Service, the Italian health systems and the Bill & Melinda Gates Foundation. Much of our growth this year has been driven by delivering rapid COVID testing in health systems, emergency rooms, retail pharmacy chains and other community settings. The numbers we posted today demonstrate the beginning of the utility of the platform and its tremendous growth potential from $139 million revenues for the -- for this 2020 year as a whole to $109 million just this quarter and $303 million in revenues for the first 9 months of '21.

  • More broadly, the pandemic has accelerated our vision to transform point-of-care diagnostics and enable the shipment of more than 19,000 platforms through Q3 of this year. Particularly, for our long-term growth potential, we have a pipeline of over 30 diagnostic tests that could be performed on the platform for common health conditions, including infectious disease, cardiovascular disease, diabetes and coagulation disorders. We currently have 5 products on the market. Our high-sensitivity COVID antigen test is being deployed globally to meet the urgent need to manage the COVID pandemic.

  • In addition to our antigen, we offer a COVID antibody test, which is just starting to ship now, and a COVID antigen pool test. COVID antigen pool test enables 5 samples to be processed on a single test strip, offering the same lab comparable performance as our current antigen test at higher patient throughput and lower cost.

  • The platform also offers our INR test for monitoring patients on anticoagulation therapy such as Warfarin and our D-Dimer test for aiding in the diagnosis of deep vein thrombosis and pulmonary embolism.

  • In addition, our Fast Lab Solutions business is serving central laboratories with its high complexity molecular reagents. Our INRstar complete COVID-19 assay offers groundbreaking speed and performance on open channel PCR analyzers to enhance quality and turnaround times for central lab testing.

  • Our long-term growth is supported by an advanced manufacturing base that allows us to supply the world with the LumiraDx platforms with lab comparable performance and capacity to produce the amount of testing we expect to be needed to meet demand at affordable cost.

  • In summary, we are just beginning to drive the transformation in point-of-care testing and pursuing the $50 million dollar-plus -- $50 billion-plus global market opportunity for LumiraDx platform.

  • With that, I'll hand things over to Dorian to go into our financial performance. Dorian?

  • Dorian LeBlanc - CFO & VP of Global Operations

  • Thanks, Ron, and good morning. For the first 3 quarters of 2021, LumiraDx has delivered $303.2 million in revenue, or more than 10x our revenue of $26.9 million during the first 3 quarters of 2020, which reads $109.1 million in revenue in the third quarter of 2021. COVID antigen test strips accounted for $92 million of revenue in quarter 3, while our Fast Lab Solutions delivered Q3 revenue of $10.3 million as adoption of our unique molecular chemistry has been accelerating.

  • Gross margin for the third quarter was 36% and gross margin for the 9 months ended September 30, 2021, was 32%. The underlying gross margin on test strips in Q3 was 59%. This includes the impact of approximately 20 points of margin that were associated with inventory scrap, overheads and production yields related to continued maturation of our manufacturing capabilities and our scale-up costs for production capacity build. Core test strip margins are well above our long-term guidance presented in July, reflecting the low cost design of the product and the highly automated nature of our manufacturing process.

  • Research and development costs were $35.4 million in the quarter. This represents an increase of 27% over the comparable quarter in 2020 as we continued to increase capabilities, opened our new R&D center in Glasgow and further resourced our development teams for continued pipeline delivery.

  • Third quarter SG&A expenses of $58.9 million includes an IFRS 2 charge of $22.2 million for the difference in the fair value of the shares deemed to have been issued by LumiraDx in the merger transaction to CA Healthcare shareholders and the net assets of CA Healthcare and $8.6 million of LumiraDx transaction costs as part of LumiraDx's transaction to go public on NASDAQ. Excluding these items, SG&A expenses were $28.1 million, an increase of $15.9 million from the third quarter of 2020 as we expanded staffing globally to support the commercial growth of LumiraDx platform and Fast Lab Solutions.

  • Net income for the third quarter of 2021 was $84.8 million, or $0.46 per fully diluted share. Net income arose from certain accounting gains on the conversion of our debt and equity securities as part of the merger. Our non-IFRS adjusted net loss for the period, excluding merger-related items and excluding amortization, share-based payment expenses and unrealized foreign exchange gains, was $29.8 million, or a loss of $0.16 per share.

  • As a result of the merger with CA Healthcare and our NASDAQ listing, our preferred shares and convertible debt automatically converted into LumiraDx A ordinary or common shares. IFRS accounting for these conversions includes noncash gains and losses detailed in our reconciliation of IFRS financial measures to non-IFRS financial measures. We currently have approximately 207.5 million A ordinary shares and 45.2 million common shares, representing a combined total of 252.7 million shares outstanding.

  • At September 30, we had $300 million in senior debt and $18 million in other term debt. Our cash balance at September 30 was $217.7 million, and included the $38.2 million of cash and trust from the merger, but did not include many of the cash expenses related to closing the merger, which were subsequently settled in October. Looking to the remainder of the year, we currently expect full year revenue for 2021 to be substantially in line with the average consensus analyst estimate of $367 million.

  • As we enter 2022, we are focused on continuing to support the COVID testing requirements of our existing customers, expanding the installed base of instruments across both existing and new customers, driving continued success of our Fast Lab Solutions and most importantly, delivering on our pipeline to provide additional fast, accurate and cost-effective point-of-care testing solutions.

  • Before taking your questions, Pooja will review the recent -- upcoming milestones for continuing our business progress. Pooja?

  • Pooja S. Pathak - Chief Product Officer

  • Thanks, Dorian. We have made progress in growing our existing product lines as well as developing our pipeline. I will start with several regulatory updates and customer feedback for on-market products.

  • In August, we received FDA Emergency Use Authorization, or EUA, for our COVID antibody test, allowing COVID antigen and antibody testing on a single platform. This is valuable to a number of our key customers to whom we will begin shipping shortly. Last week, our COVID antigen test received expanded claims from FDA under EUA for asymptomatic use in the U.S.

  • In clinical studies, the test demonstrated 82.1% positive agreement and 100% negative agreement to laboratory RT-PCR. These results, recently published in the American Journal of Clinical Pathology, showed 100% positive agreement in individuals below CT30 and 96% positive agreement in individuals below CT33, supporting the test use in detecting infectious individuals with mid- to low viral loads.

  • We are excited about the expanded claims for our COVID antigen test and pleased with our competitive product performance. There are now 18 COVID antigen tests on the market approved for use in symptom-free individuals, 3 of which, including ours, are authorized for use as single test. We believe the LumiraDx COVID antigen test is the only professional use test that does not require serial testing.

  • In terms of international development, the COVID antigen test received regulatory authorizations in India and Brazil. We have also completed local registration in several African countries to enable a transition from the global health donations to in-country procurement. Our platform and COVID antigen test continue to receive positive feedback from customers. The combination of speed, sensitivity and differentiated claims enabled it to deliver a unique value proposition in the diagnostic screening and surveillance markets.

  • Within the diagnostic testing segment, our COVID antigen test is often used as an alternative to PCR. Just as an example, prior to implementing point-of-care testing in the emergency department, the National Health Service in the U.K. and Showa University Hospital in Japan were sending COVID testing out to laboratories and waiting 24 to 36 hours for results. They've been delighted with the LumiraDx platform performance and impact to patient workflow. They're keenly awaiting the future testing menu.

  • Within the screening and surveillance segments, customers in Europe, mainly in Italy and Germany, are responding well to the COVID antigen pool test, which provides high throughput and low-cost testing capabilities on a high-sensitivity connected platform. We are seeing uptake for this product in screening up to 5 people at a time in cruise ship, schools and public events. Having now received the asymptomatic claim in the U.S., we plan to submit an FDA EUA for our COVID antigen pool test this quarter.

  • Our INR test continues to do well in key European markets and D-Dimer early market feedback has also been positive. Our near-term commercial focus remains on COVID antigen test, however, and we continue to launch in new markets consistent with our global commercial strategy.

  • On the new product side, in October, we submitted an FDA EUA for our Flu A, Flu B and COVID antigen combination test. We are responding to the FDA's questions on the application. And subject to FDA authorization, we are targeting making Flu COVID test available commercially during this flu season. We are also working towards European and Japanese regulatory authorization for this combination product.

  • Product development for our CRP test for use in infection management and antibiotic prescription is ongoing with CE Mark planned by end of the year. And for Amira, we have been working through supply issues for a few of the device components that have impacted product development. We are planning to initiate clinical studies in the first quarter of next year.

  • Finally, in our Fast Lab Solutions business, we submitted for additional claims under EUA on our RNA STAR Complete molecular COVID assay, including asymptomatic pooling and home self-collection. We have additional tests in development to expand testing capabilities for our molecular lab customers.

  • Looking ahead to next year, we continue to execute on our pipeline plan. We have, on our 18-month road map, the most frequently used test at point of care as well as opportunities to deliver on the largest unmet needs in community care settings including HbA1c, troponin, BNP, Strep A, TB and others. These programs are progressing well, and we intend to cover further as part of our next earnings call.

  • With that, we'd be happy to take your questions. Operator?

  • Operator

  • (Operator Instructions) Our first question comes from the line of Vijay Kumar with Evercore.

  • Vijay Muniyappa Kumar - Senior MD

  • Maybe on -- starting with your comments, Dorian, on comfortable [but sweet] estimates for the implied, I think, Q4 is 60-ish, mid-60s revenues. Considering you guys just did $109 million, is -- what is the primary driver of the sequential decline? Are you assuming lower COVID revenues? Is that based on the broad market trends? Or is that more -- anything specific to Lumira?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, we're concerned simply about being able to predict the volatility of the virus. It's behaved in a surprising way early in the year. It could behave that way even in the remaining time of this quarter. So I think it's quite important to be prudent and not to try and outthink or outpredict the behavior of the virus and human reaction to the virus, both of which are very hard to predict.

  • Vijay Muniyappa Kumar - Senior MD

  • Sorry, Ron, just to clarify that, your assumptions on those Q4 revenues, that's based on the market trends, right? Like there is no reason your performance on COVID should be any different from the market, correct? You're just assuming a lower overall testing environment and this is the market environment...

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • We haven't seen from any customers a change in pattern of usage in their hands of our platform. But really, that doesn't mean it won't change going forward. We haven't seen that change, but we could see it. So there could be issues. I mean issues related to the viral -- to the behavior.

  • Vijay Muniyappa Kumar - Senior MD

  • Understood. And Dorian, one for you on gross margins and supply chain commentary here. I think some of the numbers went by too quickly. So what is the difference between the reported 36% gross margins and the underlying strip margins of, I think you said 59%? And I think you mentioned a 20-point delta between the strip margins of 59% due to manufacturing or supply chain costs. Could you parse out what is your versus supply chain issues? And when should these issues be resolved?

  • Dorian LeBlanc - CFO & VP of Global Operations

  • So Vijay, our focus is on long-term test strip margins. That's really the driver of profitability for the business. So we are well on track there. We have installed a tremendous amount of manufacturing capacity over the last year. I think you can see that in the balance sheet and the cash flow, more than $80 million invested in 2021, in expanding the manufacturing capacity. And so those costs -- the cost of staffing all of that up and the impact on yields and production all flowing through cost of goods impacted test strip margins by about 20 basis points.

  • So without those costs, we would expect test strip margins to be much, much higher and, as we said, way above our -- the guidance -- the long-term guidance we gave in July. So we're already seeing a lot of that clear here in -- early in the fourth quarter and optimistic about how that plays out. Obviously, there's other impacts in margin as well besides test strips, but that's really where our focus is for long term.

  • Vijay Muniyappa Kumar - Senior MD

  • Understood. And then one last one, if I may, for Pooja. I think you mentioned the combo test submission. When is the approval expected? Like do we have a specific data on when you guys made the submission -- EUA submission? And is there an ASP differential between combo versus stand-alone COVID antigen test?

  • Pooja S. Pathak - Chief Product Officer

  • Thanks, Vijay. Yes, we've made the submission. And you know, it's hard to know exactly what the time lines are for the approval process. We're actively answering the FDA's questions. There will be a price difference on COVID flu versus COVID.

  • Operator

  • Your next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann.

  • Jeffrey Scott Cohen - MD of Equity Research

  • So could you talk about the 19,000 platform as far as the coming months is -- is there an anticipated platform number that you're reaching to? Or you're comfortable where that's at currently?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, the number is -- of installed is way ahead of where we would have expected to be, and obviously it's simply driven by COVID antigen demand around the world. And we don't really know what the demand will be going forward. So it's very hard to say. We are getting a lot of interest -- or a huge amount of interest as a result of the CRP, the Flu A, Flu B COVID coming through. We've got some other tests coming early next year. So we are seeing tremendous requests from customers.

  • So I think it's fair to say that we should have a lot of place -- we should have a lot of placements next year, not driven by COVID, although there could still be a lot of COVID demand, who knows.

  • Jeffrey Scott Cohen - MD of Equity Research

  • Got it. Can you talk about the Fast Lab business a little bit? Any sense of number or size of molecular lab customers out there? And any forward-looking statements on projected growth within that segment?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, at the moment -- I mean we developed the platform in order to be helpful in the pandemic in the first place, and it turns out, it's very helpful because labs are obviously needing to get higher throughput. So it's working out well, and we are actually adding customers.

  • But again, trying to peer into the future, when initially it's so COVID dependent is pretty hard, although we do have a program of adding a series of other test onto the platform to diversify away from COVID because having got into this business -- into the lab business, which we obviously haven't intended to, but we did as a response to the pandemic, customers are asking for additional tests. And we're in the process of addressing that.

  • Jeffrey Scott Cohen - MD of Equity Research

  • Got it. And could you give us a sense of activities going on in Stirling, how many lines are up and running? And what type of throughput numbers currently as far as capabilities and perhaps throughput numbers in the coming months?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, I think we've said that we've got plenty of capacity and -- to meet the demand. I don't think we're going to go into numbers simply because we -- it's impossible to predict. But any demand that will come up to us, we have the capacity in place. Much of the capacity in Stirling is increasingly being devoted to non-COVID development because the pace of launching products now that we're in the pro -- now that we've been bumped to a substantial extent, the hole process of launching the product as we've had more experience, because remember, we're at the very early stages of the life cycle of our products.

  • So there's a huge amount of learnings going on. And as those learnings have improved, the rate at which we're launching new products is going up. As you can see from this year, just the 5 or 6 that we hopefully will have launched this year relative to the 1 last year and so on. So -- and that pace will accelerate. And to launch the products, you need to devote substantial manufacturing capacity for validation purposes and so on.

  • And so increasing amount of capacity in Stirling is being devoted to the various products that we're launching, not only this year, not only the remaining this year of Flu A, Flu B, but additional for all the tests from next year. So there's a huge amount of activity on the manufacturing lines as a result of getting ready to launch a slew of new tests.

  • Jeffrey Scott Cohen - MD of Equity Research

  • Okay. Got it. And then lastly for us, could you talk about the Flu A, B combo? When that's on the market, how would you expect the uptake to look and the effect and ramifications upon the existing testing platform in the antigen space?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, first of all, it's very hard to know. It's a little bit awkward to answer this question, the same way that we -- we just answered the COVID question because, of course, flu itself is unpredictable, not quite as unpredictable as COVID antigen, but who knows what kind of a season we're about to be. We could end up with stocking orders and very little follow-through if the season doesn't get there. We could have delayed stocking as customers sort of wait -- basically wait to see, even though everyone's nervous about the flu season, there isn't a flu season and customers could end up waiting and not ordering.

  • So I'm afraid I can't be very specific, but we will be ready. We expect to get the various regulatory clearances. The product performance is very good. The limit of detection is -- differentiates that we have is -- is highly differentiated as you would expect on our platform relative to the market and to the market needs. That's highly differentiated and performance is very, very good.

  • But it's -- any predictions are difficult to make, but we're ready to meet where we expect to deal with the major regulatory authorities satisfactorily, and we expect to be able to ship if the demand turns out to be there.

  • Operator

  • Your next question comes from the line of Andrew Cooper with Raymond James.

  • Andrew Harris Cooper - Senior Research Associate

  • Maybe first, just diving a little bit more on the installed base and maybe the shipment specifically that you had in the third quarter. Can you give us a little bit of sense for geographic mix and maybe end market mix? Obviously, I think CVS has taken a lot already domestically.

  • I know we talked about Gates Foundation really kind of around the turn of the year. So just want to get a sense for where a lot of the 4,000-plus instruments shipped this quarter are actually landing? If you could give us a little bit of color there.

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, actually, it was disproportionately the U.S. and substantial additional shipments to CVS actually. So -- and as well as many health systems in the U.S. and as well as shipments around Europe, and I think Japan. Japan was -- has come in line as you probably know. But it was actually disproportionately -- Q3 was disproportionately U.S. based.

  • Andrew Harris Cooper - Senior Research Associate

  • Okay. Helpful. And are there any kind of material volumes in that, that you would kind of put in the bucket you've talked about a little bit before of sort of pandemic-only use cases like cruise ships and things like that where maybe they're not as durable relative to a CVS or a health system where, obviously, with more menu, they'll continue to use the product post pandemic?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, Andrew, I don't have the percentage, but it was massively -- it was overwhelming in locations, which will carry on using the product. I don't know what the percentage is, but it was very high. I don't know if, Dorian, you happen to have the number, but it's overwhelmingly continuation.

  • Andrew Harris Cooper - Senior Research Associate

  • Okay. Great. Don't need an exact -- sorry, go ahead, Dorian.

  • Dorian LeBlanc - CFO & VP of Global Operations

  • Yes, so we can follow up with you on that potentially on our fourth quarter call and breaking out numbers, but overwhelmingly in the locations where we want to be long term. And as Ron said, concentrated in the U.S.

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • (inaudible), Andrew, but well north of 90%.

  • Andrew Harris Cooper - Senior Research Associate

  • That's super helpful. That's -- I just want to kind of make sure that we don't have anything that's sort of the noncontinuing customer at the end of the day. And then you mentioned a little bit of challenges on Amira in terms of, I think, really supply chain and getting some of the components.

  • Can you go into a little more detail on what that is? And how you think about that product hitting the market in -- sometime next year when hopefully, for the sake of the world, we're not quite as worried about the pandemic? So just a little bit of context for how you think about Amira coming to market.

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, it's tricky and it was particularly impacted by our ability to get chips and particularly chips that are cheap. And they're not -- there's such a scarcity that it's created all kinds of complications, including ability to sort of finish development work and that sort of thing. But having said all of that, I think we have a good shot at making a good deal of progress early next year and getting the product out.

  • Andrew Harris Cooper - Senior Research Associate

  • Okay. Great. And then maybe just one on the model. To the degree you can answer this, when we look at trying to normalize out some of the onetime costs and look at R&D and SG&A, obviously, gross margins we've talked about. But when you think about that ramp as we move into '22 and into the fourth quarter, anything to call out in terms of sort of the progression in terms of just modeling purposes?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Dorian?

  • Dorian LeBlanc - CFO & VP of Global Operations

  • Yes, I think if you want to look at the reconciliation and you can see where the components that we pulled out, that will get you to a pretty good, normalized run rate and really head count has been the same Q2, Q3 and will likely remain relatively the same into Q4 as most of our ramp's completed. So the...

  • Andrew Harris Cooper - Senior Research Associate

  • Okay. And then ramp as new menu comes along?

  • Dorian LeBlanc - CFO & VP of Global Operations

  • Exactly. The impact of new menu and clinicals and things will add some to R&D into 2022 with a launch of new products. But right now, we're pretty stable.

  • Operator

  • Our next question comes from the line of Mark Massaro with BTIG.

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • My first one is on actually the COVID antibody test. Obviously, you've had very strong demand for your COVID antigen test. Can you just give us a sense for any inbound interest you've had on it? Or whether or not some of your larger customers like the NHS or CVS are planning to offer it?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Well, without commenting on specific -- without commenting on exactly what specific customers are planning to do, in deference to them, we are, in fact, getting such input. We are, in fact, getting such inquiries. And so I do expect to ship to them -- to large customers as well as smaller customers, which have already been underway.

  • I have to say that I don't think in general that the COVID antibody is going to be an overwhelmingly large test, but that's a personal view. I could be wrong. It could be that the public is going to really want to have a handle on this because of the effectiveness of vaccines and so on.

  • So it could be wrong. But I don't think this will be a particularly large product, but you just -- it's hard to know. But yes -- but to answer your question, yes, some of the larger people probably will take it.

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • Okay. That's helpful. And then can you speak for the expanded claim for asymptomatic patients? I mean what are your expectations? It's pretty intuitive that people who have symptoms would probably have peace of mind and would like to understand whether or not they are infected with COVID or not. But for those who are not symptomatic, I guess, walk us through use cases or what your expectations might be for the uptake of that test?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • That's also another difficult question. You guys are really peppering us with hard questions. It's very hard -- Mark, it's very hard to know because firstly, most people have been going in and fibbing about whether they're asymptomatic in order to get tested anyway. So many, many people who are asymptomatic have been getting tested anyway.

  • But there are also -- the more thoughtful customers have been sticking more closely to the rules and have been using the platforms more strictly according to the cleared use cases, the authorized under the EUA use cases. And some of those customers are already having discussions with us as a result of this because of the high -- the general high performance of our product that many customers are using it in lieu of PCR because we have very high performance as Pooja laid out.

  • As you probably know already, in cycle times, under 33. And so as customers are using it in lieu of PCR, it helps tremendously in asymptomatic patients. So those customers are likely to start adopting the platform.

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • That's helpful. And can you just remind us or refresh investors listening in, is it fair to assume that you are continuing or that you expect to continue to receive test orders for both CVS and the NHS through 2022? Are there any type of contractual items that might need to be signed roughly by year-end?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • I don't think there's any contractual items, but you know in practice, there is not really even a contract that's meaningful, right? It's basically just buying based on demand. Dorian, I don't -- so in general, Mark, we don't really have -- we haven't got a contract where they sort of have to take product in the long term.

  • Dorian, do you have a comment?

  • Dorian LeBlanc - CFO & VP of Global Operations

  • I agree, Ron. Nothing else to add, agreed.

  • Mark Anthony Massaro - MD & Life Science & Diagnostic Tools Analyst

  • Okay. And then just -- that's helpful. My last question for you, Ron. Obviously, you and your team have been hard at work for 7 years. Can you just remind us -- I feel like a lot of companies that are offering point-of-care infectious disease testing tend to focus in the U.S. markets. It does seem that your cost structure is well suited for the emerging world and countries outside of the United States.

  • Can you just sort of remind us what your plans are in terms of going direct in certain countries? I know you already are in a number of countries, but just how you think you're differentiated relative to a number of, what I would call, the more U.S.-centric-focused companies? And how you think your platform is ideally suited to penetrate OUS markets as well as many markets that are already established in the U.S.?

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Mark, thanks for that question. But you asked it from an infectious disease perspective, remember that our platform and our raison d'etre is infectious diseases, but it's cardiology, it's diabetes, it's coagulation monitoring. And of course, these diseases are everywhere. And our approach is -- and we believe that the best way of getting market share and getting closer to the customers and, therefore, being able to grow at a faster rate is having our own operations on the ground.

  • And obviously, with COVID, it's enabled us to accelerate the process. So we have feet on the ground in many of the major countries. I think the only very large country that we're missing is China, which we'll add in due course with our own sales and marketing operation, not that we don't use local wholesalers and so on, but we'll have our own people. So we are internationally focused from day 1. We're not at all U.S. focused, although we can't help it because we have a couple of big -- we have a big customer in the U.S., but we're adding numerous customers around the world. We'll have our own operations around the world.

  • And more importantly, sort of both related to infectious disease, but more importantly, unrelated to infectious diseases, the pipeline of new products is accelerating. And we need this sort of commercial platform around the world to help us absorb and work with key opinion leaders in numerous countries for each of the tests as they're coming out. And this next year, between now and the end of next year, is going to be incredibly busy with numerous product launches because by the end of next year, we'll have most of the major tests that are now available, we'll have them all on a single platform with exclusive performance, lab-comparable performance.

  • And there'll be a number of tests which currently are not -- either not used or essentially unavailable in point of care because of performance. So we'll have those on the platform as well. So yes, we're very focused on around the world because of -- not just because of infectious diseases, but broadly because of the very nature of the platform.

  • Operator

  • There are no further questions at this time. I'll hand back the call over to Mr. Ron Zwanziger for closing remarks.

  • Ron Zwanziger - CEO, Co-Founder & Chairman

  • Thanks, everyone, for your questions and your interest. And I'd like to just close by just emphasizing that we're just at the beginning of our journey to transform community-based testing with 5 tests currently on our platform and plans for a menu of these 30-plus assays to change how health care is delivered worldwide.

  • As I just mentioned in response to the -- actually the last question from Mark, is the rate of launching of new tests has started to increase. And we'll do so at a much accelerated rate as we execute our long-term strategy and right revenue growth in years to come.

  • So we'd like to thank you again for your questions and for joining today's call, and we look forward to updating you on our company's progress. Thanks very much.

  • Operator

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