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Operator
00:08 Good day everyone. Thank you for standing by, and welcome to the LumiraDx Third Quarter twenty twenty one Earnings Conference call.
At this time, all participants are in a listen-only mode. [Operator Instructions] 00:32 I will now hand the conference over to Colleen McMillen, Vice President of Communications.
Thank you. Please go ahead.
Colleen McMillen
00:40 Hello, everyone. We'd like to welcome you to today's call to discuss LumiraDx’s third quarter 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. 01:00 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 any statements you make today other than historical facts are forward looking statements made pursuant to the Safe Harbor provisions as a Private Securities Litigation Reform Act of nineteen ninety five. 01:24 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 tenth, twenty twenty one 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.
01:46 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 and our press release issued earlier today, which can be found on our website at lumiradx.com.
02:07 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
02:18 Thanks Colleen, and thank you all for joining our call today. We've been working to build LumiraDx for seven years now with a vision of transforming community based care by providing fast, accurate, and comprehensive diagnostic information to healthcare providers at the point of need.
Our next generation diagnostic testing solution is designed to be affordable and accessible for every individual around the world. 02:43 COVID exposed a further need for point of care testing with lab comparable results in minutes.
Our micro microfluidic technology and platform are proven to meet the market needs to fast high sensitivity, convenient, and connected diagnostic test results. 03:00 We have successfully gone into the market with customers and partners, including CVS, the UK 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 change and other community settings. 03:21 The numbers we posted today demonstrate the beginning of the utility of the platform and its tremendous growth potential from one hundred and thirty nine million revenues for the first twenty year as a whole to one zero nine million just this quarter and three zero three million of revenues for the first nine months of twenty one.
03:40 More broadly, the pandemic has accelerated our vision to transform point of care diagnostics and enable the shipment of more than nineteen thousand platforms through Q3 of this year. Particularly, for our long term growth potential, we have a pipeline of over thirty diagnostic tests that could be performed on the platform for common health conditions, including infectious disease, cardiovascular disease, diabetes, and coagulation disorders.
04:08 We currently have five 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 five samples to be processed on a single test strip, offering the same lab performance as our current Antigen Test at higher patient throughput and lower cost. 04:38 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.
04:51 In addition, our Fast Lab Solution business is serving central laboratories, which is high complexity molecular reagents. Our INR start complete COVID-nineteen assay answers groundbreaking speed and performance on open channel PCR analyzers to enhance quality and turnaround times for central lab testing.
05:13 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. 05:30 In summary, we're just beginning to drive the transformation in point of care testing and pursuing the fifty billion dollar plus global market opportunity for LumiraDx platform.
05:41 With that, I’ll hand things over to Dorian to go into our financial performance. Dorian?
Dorian LeBlanc
05:48 Thanks, Ron, and good morning. For the first three quarters of twenty twenty one, LumiraDx has delivered three hundred and three point two million in revenue or more than ten times our revenue of twenty six point nine million during the first three quarters of twenty twenty.
We issued one hundred and nine point one million in revenue for the third quarter of twenty twenty one. 06:08 COVID Antigen Test strips accounted for ninety two million of revenue in quarter three.
While our Fast Lab Solutions delivered Q3 revenue of ten point three million as adoption of our unique molecular chemistry has been accelerating. 06:22 Gross margin for the third quarter was thirty six percent in gross margin for the nine months ended September 30, twenty twenty one was thirty two percent.
The underlying gross margin on test strips in Q3 was fifty nine percent. This includes the impact of approximately twenty points of margin that were associated with inventory scrap, overheads, and production yields related with the continued maturation of our manufacturing capabilities and our scale-up costs for our production capacity build.
06:53 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 thirty five point four million in the quarter.
This represents an increase of twenty seven percent over the comparable quarter in twenty twenty as we continue to increase capabilities, opened our new R&D center in Glasgow and further resourced our development teams for continued pipeline delivery. 07:23 Third quarter SG and A expenses of fifty eight point nine million includes an IFRS two charge of twenty two point two 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 eight point six million of LumiraDx transaction costs as part of LumiraDx's transaction to go public on NASDAQ.
07:52 Excluding these items, SG and A expenses were twenty eight point one million, an increase of fifteen point nine million from the third quarter of twenty twenty as we expanded staffing globally to support the commercial growth of LumiraDx platform and Fast Lab Solutions. 08:08 Net income for the third quarter of twenty twenty one was eighty four point eight million or zero point four six dollars 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. 08:24 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 twenty nine point eight million dollars or a loss of zero point one six dollars per share.
08:40 As a result of the merger CA Healthcare on NASDAQ listing, our preferred shares in convertible debt automatically converted into LumiraDx a ordinary or common shares. IFRS accounting for these conversions includes non-cash gains and losses detailed and our reconciliation of IFRS financial measures to non-IFRS financial measures.
09:00 We currently have approximately two hundred and seven point five million a ordinary shares and forty five point two million common shares, representing a combined total of two fifty two point seven million shares outstanding. 09:13 At September thirty, we had three hundred million in senior debt and eighteen million in other term debt.
Our cash balance at September 30 was two hundred and seventeen point seven million and included the thirty eight point two 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. 09:37 Looking to the remainder of the year, we currently expect full year revenue for twenty twenty one to be substantially in line with the average consensus analyst estimate of three sixty seven million.
As we enter twenty twenty two, 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. 10:16 Before taking your questions, Pooja will review the recent upcoming milestones for continuing our business progress.
Pooja?
Pooja Pathak
10:25 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 be again shipping shortly. 10:53 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 eighty two point one percent positive agreement and one hundred percent negative agreement to laboratory RT PCR. These results recently published in the American Journal of Clinical Pathology showed one hundred percent positive agreement in individuals below Ct 30 and ninety six percent positive agreements in individuals below Ct 33, supporting the test use in detecting infectious individuals with mid to [low viral] [ph].
11:29 We are excited about the expanded claims for our COVID Antigen Test and pleased with our competitive product performance. There are now eighteen COVID Antigen Tests on the market approved for use in symptom free individuals, three of which including ours are authorized for use as single test.
11:46 We believe the LumiraDx COVID Antigen Test is the only professional use test that does not require serial testing. In terms of international developments, the COVID Antigen Test received regulatory organizations in India and Brazil.
We have also completed local registration in several African countries to enable a transition from the global health donation to in-country procurement. 12:09 Our platform in COVID Antigen Tests continue to receive positive feedback from customers.
The combination of speed, sensitivity, and differentiated claims enables it to deliver a unique value proposition in the diagnostic screening and surveillance markets. 12:25 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 UK and Showa University Hospital in Japan we’re sending COVID testing out to laboratory, and waiting twenty four to thirty six hours for results. They've been delighted with the LumiraDx platform performance and impact to patient workflow.
They are keenly awaiting the future testing menu. 12:55 Within the screening and surveillance segments, customers in Europe, mainly in Italy and Germany are responding well to the COVID Antigen Flu 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 five people at a time in [indiscernible] school and public events. Having now received the asymptomatic claim in the U.S., we plan to submit an FDA UA for our COVID Antigen Pool Test this quarter.
13:25 Our INR Test continues to do well in key European markets, and D-Dimer early market feedbacks also have been positive. Our near-term commercial focus remains on COVID Antigen Test however, and we continue to launch new markets consistent with our global commercial strategy.
13:42 On the new product side, in October, we submitted an FDA UA for our Flu A/B and COVID Antigen combination test. We are responding to the FDA's questions on the application and subject to FDA authorizations, we are targeting making flu COVID tests available commercially during this flu season.
We are also working toward European and Japanese regulatory authorization for this combination product. 14:07 Product development for our CRP test for use in infection management and antibiotic prescription is ongoing with CE Mark planed by end of year.
And for [EMEA] [ph], 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. 14:28 Finally, in our Fast Lab Solutions business, we submitted for additional claims under EUA on our RNA complete molecular COVID assay including asymptomatic pooling and home self-collection.
We have additional test and development to expand testing capabilities for our molecular lab customers. 14:46 Looking ahead to next year, we continue to execute on our pipeline plan.
We have on our eighteen month roadmap, 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, [indiscernible] TB and others. These programs are progressing well and we intend to cover further as part of our next earnings call.
15:11 With that, we'd be happy to take your question. Operator?
Operator
15:18 [Operator Instructions] Our first question comes from the line of Vijay Kumar with Evercore. Your line is now open.
Vijay Kumar
15:38 Hey guys congrats and thanks for taking my question. Maybe on starting with your comments Dorian on comfortable [indiscernible] estimates, for the implied I think Q4 is sixty-ish, mid-60’s revenues.
Considering guys just did one hundred and nine, what is the primary driver of the sequential decline? Are you assuming lower code revenues?
Is that based on the broad market claims or is that more anything specific to LumiraDx?
Ron Zwanziger
16:16 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 out think or out predict the behavior of the virus and human reaction to the virus, both of which are sort very hard to predict.
Vijay Kumar
16:53 Sorry, Ron, just to clarify that, are 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 does [Multiple Speakers].
Ron Zwanziger
17:17 We haven't seen from any customers a change in patent of usage in their hands about platform. But really that doesn't mean it won't change and going forward.
We haven't seen that change, but we could see it so there could be issues. I mean issues related to the behavior.
Vijay Kumar
17:49 Understood, and now, Dorian one for you on the gross margins and supply chain commentary here. I think so the numbers went by too quickly.
So, what is the difference between the reported thirty six percent gross margins and the underlying strip margins of, I think you said fifty nine percent and I think you mentioned a twenty point data between the strip margins of fifty nine due to manufacturing supply chain costs. Could you parse of what this year versus supply chain issues?
And when should these issues be resolved?
Dorian LeBlanc
18:35 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 eighty million invested in twenty twenty one in expanding the manufacturing capacity.
19:03 And so, those costs of staffing all that up and the impact on yields and production of cost of goods impacted test strip margins by about twenty basis points. So, without those costs, we would expect test strip margins to be much, much higher and as we said, way above the guidance, the long term guidance we gave in July.
19:30 So, we are already seeing a lot of that clear here 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 Kumar
19:49 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 date on when you guys made the submission, EUA submission? And is there an ASP differential between combo versus standalone COVID Antigen test?
Pooja Pathak
20:11 Thanks, Vijay. Yes, we've made the submission, as you know it’s hard to know exactly what the timelines are for the approval process.
We're actively answering the FDA's questions. There will be a price difference on COVID flu versus COVID.
Vijay Kumar
20:33 Understood. Thanks guys.
Operator
20:38 Your next question comes from the line of Jeffrey Cohen with Ladenburg Thalmann. Your line is now open.
Jeffrey Cohen
20:45 Good morning, Ron, Dorian, Pooja how are you?
Ron Zwanziger
20:50 Very good, Jeff.
Jeffrey Cohen
20:51 So, could you talk about the nineteen thousand platform as far as the coming months? Is there anticipated platform number that you're reaching to or your comfortable where that’s at currently?
Dorian LeBlanc
21:14 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 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, a huge amount of interest as a result of the CRP flu A, flu B COVID coming through.
21:56 We got some other tests coming early next year. So, we are seeing tremendous request from customers.
So, I think it's fair to say that we should have a lot of placements next year. I'm not driven by COVID, although there could still be a lot of COVID demand who knows.
Jeffrey Cohen
22:19 Can you talk about the [indiscernible] business a little bit, any sense of number or size and molecular lab customers out there and any forward looking statements on projected growth within that segment?
Dorian LeBlanc
22:36 Well, at the moment, we developed the platform in order to be helpful and 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, so COVID dependent is pretty hard.
23:01 Although we do have a program of adding the series above the test onto of 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 Cohen
23:24 Got it. And could you give us a sense of activities going on in Sterling, how many lines are up and running and what type of throughput numbers are currently as far as capability is in perhaps throughput numbers in the coming months.
Dorian LeBlanc
23:42 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 it's impossible to predict, but any demand that will come up to us, we have the capacity in place.
24:02 Much of the capacity in sterling is increasingly being devoted to non-COVID development because the pace of launching products now that we're in the probe, now that we've [indiscernible] to a substantial extend the whole 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. 24:39 As you can see from this year, just the five or six that we hopefully will have launched this year relative to the one last year and so on.
So, and that pace will accelerate and to launch the products you need to divert substantial manufacturing capacity for validation purposes and so on. And so, increasing amount of capacity in sterling is being devoted to the various products that we're launching.
25:08 Not only this year, not only the remaining this year Flu A/B, but additional or all the tests from next year, so there's huge amount of activity on the manufacturing lines as a result of getting ready to launch a set of new tests.
Jeffrey Cohen
25:27 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 on applications upon the existing testing platform in the Antigen space?
Dorian LeBlanc
25:51 Well, first of all, it's very hard to know. It's a little bit over time for this question.
The same way that we just answered the COVID question because of course fluid 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. 26:20 If the season doesn't get there, we could have delayed stocking as customers sort of wait, basically wait to see even though everyone is nervous about the flu season, there isn't a flu season and customers could end up waiting and not ordering.
26:36 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 limited detection is – differentiates that we have is highly differentiated as you could expect on our platform relative to the market and to market needs, that’s highly differentiated and the performance is very, very good.
But any predictions are different to make. But we're ready to meet where we expect to deal with the major regulatory authorities, satisfactory and we expect to be we expect to be able to ship if the demand turns out to be there.
Jeffrey Cohen
27:22 Got it. Okay, perfect.
Thanks for taking our questions.
Operator
27:29 Your next question comes from the line of Andrew Cooper with Raymond James. Your line is now open.
Andrew Cooper
27:36 Hi, everybody. Thanks for the questions.
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, you know 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 four thousand plus instruments shift this quarter are actually landing if you could give us a little bit of color there?
Ron Zwanziger
28:09 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., as well as shipments around Europe and I think Japan was as a common line as you probably know, but it was actually disproportionately, Q3 was disproportionately U.S. based.
Andrew Cooper
28:38 Okay. Helpful and are there, are there any kind of material volumes in that you would kind of put in the bucket you've talked about a little bit before, sort of pandemic only used cases like cruise ships and things like that or 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 first and then?
Ron Zwanziger
29:02 Well, Andrew, I don't have the percentage, but it was massively, it was overwhelming in locations, which we’ll 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 have that number, but it's overwhelmingly a continuation.
Andrew Cooper
29:25 Okay, great. Don't need an exact … Sorry go ahead, Dorian.
Dorian LeBlanc
29:28 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, concentrate in the U.S.
Ron Zwanziger
29:42 I think [Multiple Speakers] Andrew, but well north of ninety percent.
Andrew Cooper
29:47 That's super helpful. That's, I just want to kind of make sure that we don't have anything that’s sort of non-continuing 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 best products 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 about how you think about Amir coming to market?
Ron Zwanziger
30:24 Well, it's tricky, and it was particularly impacted by ability to get tips and particularly tips that are achieved. And 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 Cooper
30:57 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 one-time costs and look at R and D and SG and A, obviously, gross margins we've talked about, but when you think about that ramp as we move into twenty two and into the fourth quarter, anything to call out in terms of, sort of the progression in terms of just modeling purposes?
Dorian LeBlanc
31:26 Yeah, 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 headcount has been the same Q2, Q3 and will likely remain relatively same into Q4 as most of our ramps completed. So, the…
Andrew Cooper
31:49 Okay, and then ramp as new menu comes along?
Dorian LeBlanc
31:51 Exactly. The impact of new menu and clinical and things will add some to R and D into twenty twenty two with a launch of new products, but right now, we're pretty stable.
Andrew Cooper
32:01 Okay, great. I'll stop there.
Appreciate it.
Operator
32:06 Our next question comes from the line of Mark Massaro with BTIG. Your line is now open.
Mark Massaro
32:14 Hey guys, thanks for taking my questions. 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 in-bound interest you've had on it or whether or not some of your larger customers like the BHS or CBS are planning to offer in?
Ron Zwanziger
32:42 Well, without commenting on exactly what specific customers are planning to do, in difference to them, we are in fact, getting such – but we are in fact getting such inquiries. And so, do expect to ship to them to large customers, as well as smaller customers, which have already been underway.
33:08 I have to say that I don't think in general that the COVID Antibody is going to be an overwhelmingly large, 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. 33:30 So, it could be wrong, but I don't think this would be a particularly large product, but you just – it’s hard to know.
But yes, to answer your question, yes, some of the larger people probably will take it.
Mark Massaro
33:47 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 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 used cases or what your expectations might be for the uptake of that test?
Ron Zwanziger
34:19 Oh that's also another different question. You guys are really [indiscernible] us with our questions.
It's very hard to know because, firstly, most people have been going in and fitting about whether they are asymptomatic in order to get tested anyway. So, many, many people are asymptomatic of being getting tested anyway.
But there are also the more thoughtful customers have been sticking more closely to the rules. 34:54 And have been using the platforms more strictly according to the cleared used cases, the authorized under the EUA used cases.
And some of those customers are already having discussions with us as a result of this because of the general high performance of our, of our product that many customers are using it in lieu of PCR because we have very high performance as Pooja laid out. 35:27 As you probably know already in cycle times under thirty three, and so, as customers are using it in the lieu of PCR, it helps tremendously in asymptomatic patients.
So, those customers are likely to start adopting platform.
Mark Massaro
35:49 That's helpful. And can you just remind us or refresh investors listening in, is it fair to assume that you are continuing, that you expect to continue to receive test orders for both CVS and the NHS through twenty twenty two?
Are there any type of contractual items that might need to be signs rough by year end?
Ron Zwanziger
36:16 Oh, I don't think there's any contractual assets, but you know in practice there’s not really contracted that's meaningful [indiscernible] basically just buying based on demand. 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 something?
Dorian LeBlanc
36:36 Nothing else to add, agreed.
Mark Massaro
36:42 Okay. And then just – that's helpful.
My last question for you Ron, obviously you and your team have been hard at work for seven 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 U.S.
markets? It does seem that your structure is well suited for the emerging world in 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, 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 already established in the U.S.?
Ron Zwanziger
37:43 Mark, thanks for that question, but you asked it from an infectious disease perspective. Remember that our platform and our [indiscernible] 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 the best way of getting market share and getting closer to the customers and therefore being able to grow at a faster rate that's having our own operations on the ground. 38:17 And obviously with COVID, it's enabled us to accelerate the process that we have feet on the ground in many of 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, with our own sales and marketing operation, not that we don’t use local wholesalers and so on, but we have our own people. So, we are internationally focused from day one.
38:44 We're not at all U.S. focused, although, we can't help it because we have a couple of 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 diseases, but more importantly unrelated to infectious diseases.
39:06 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 that are coming out and this next year in between now and the end of next year is going to be incredibly busy with numerous product launches, because by the end of the next year, we'll have most of the major tests that are now available. 39:37 We'll have the more on the 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 or will 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.
Mark Massaro
40:06 That's very helpful. Thanks guys.
Operator
40:10 There are no further questions at this time. I'll hand back call over to Mr.
Ron Zwanziger for closing remarks.
Ron Zwanziger
40:18 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 five tests currently on our platform and plans for a menu of these thirty plus assays change how healthcare is delivered worldwide.
40:44 As I just mentioned, in response to the – actually the last question for Mark is the rate of launching a new test has started to increase and will 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
41:14 This concludes today's conference call. Thank you for participating.
You may now disconnect.