OraSure Technologies, Inc. (OSUR) Earnings Call Transcript & Summary

Okay. We're going to go ahead and get started. I'm Tycho Peterson. It's my pleasure to introduce our next company this afternoon, OraSure Technologies. Just a reminder, if people have questions, just submit those through the conference website, and we'll try to get to them over the Q&A. With that, let me turn it over to Stephen.

Thank you, Tycho. Hello, everyone. I'm Stephen Tang. I'm the President and Chief Executive Officer of OraSure Technologies. Before we get started, I'd like to ask everyone to turn to Slide 2 and remind you that we'll be talking about forward-looking views, which contain uncertainty and are subject to this forward-looking statement disclaimer. Turning to Slide 3. Let's all imagine a world where answers to the world's toughest health care questions are readily available, such as am I HIV positive? Do I have COVID-19? Is there a relationship between cancer and the microbiome? That's where the OraSure family of companies operates. Our innovative sampling tools, analytical services and effortless diagnostics unlock access to accurate essential information that advances global health and well-being. We are experts in infectious disease, helping to solve the world's most difficult diagnostic challenges and our sample collection and analysis technologies make us leaders in genomics in the emergency -- in the emerging microbiome field. I'd like to walk you through the investment rationale for OraSure. We are executing on a multiple near-term COVID-19 opportunities as well as other long-term growth drivers. SAP collection kits developed by our DNA Genotek subsidiary are an integral component of laboratory molecular test for COVID-19 and are generating significant revenue. We are also developing 2 tests that we believe could be key contributors to the COVID-19 testing paradigm. The COVID-19 rapid engine self-test and the lab-based oral fluid OraSure SARS-CoV-2 antibody, ELISA, both of these tests have received funding from BARDA, a division of the U.S. Department of Health and Human Services. Early on in the pandemic, we understood that increasing our manufacturing capacity will be key to meeting demand. We are in the midst of an initiative to expand our capacity for COVID-19 test and sample collection kits. Outside of COVID, we continue to expand into global markets with our OraQuick HIV Self-Test and our OraQuick HCV test. And we see tremendous growth potential in market-leading products and services focused on the microbiome and multiomics. Our ability to provide customers with both genomic and microbiome products and services is an important foundation for OraSure to become the leading source for multiomics tools and analytics. Lastly, we have $264 million in cash on our balance sheet with no debt, supporting our ongoing business development activities. These have generated 4 acquisitions and 1 divestiture since January of 2019. Since the becoming CEO of OraSure in 2018, I focused the company on an innovation-driven growth stage. We are using our core businesses and robust balance sheet to build a company with products and services that are in high demand and have significant growth opportunities. OraSure can now offer customers end-to-end solutions that will take them all the way from sample to answer. We drive across multiple layers of the information and data to understand health, wellness and disease states. All thanks to our differentiated products with competitive profiles in large markets, some like the microbiome and multiomics and they're very early stages of upside potential to come. On Slide 4, you'll see we divide our business into 3 areas: diagnostics, which includes our test for infectious disease and risk assessment, account for 48% of our revenues in 2019; sampling tools, which includes our molecular collection devices accounted for another 48% of revenue; and services, which includes our microbiome and laboratory analytical services accounted for the remaining 4% of revenue. Drilling down a bit deeper, looking at sampling tools, our subsidiaries, DNA Genotek and Novosanis offer best-in-class sample collection and stabilization devices. In the services arena, our Diversigen subsidiary is a pioneer in the emerging microbiome field, offering data analytics giving a multiomic view to health and wellness. And in diagnostics, we offer a selection of high-value actionable options for infectious disease testing and self-diagnostic testing. Turning to Slide 5. We have years of innovation and expertise in infectious disease diagnostics. We have the first and only Rapid HIV in-home test approved by the FDA and the only World Health Organization prequalified rapid oral HIV self-test. Our OraQuick rapid Ebola antigen test is the first rapid diagnostic test the FDA-cleared for marketing in the U.S. for the Ebola virus. Our technologies are the ideal platform for the emerging trends in diagnostic testing. Our proven OraQuick lateral flow platform for HIV, HCV and Ebola provides accurate and easy to administer test methods that are currently -- and well suited for the current COVID-19 testing dynamic or rapid and accurate in-home self-testing will be critical to get us through the pandemic. As you see on Slide 6, OraSure is developing test and sample collection solutions for COVID-19 across 3 modalities: molecular, antigen and antibody. Our portfolio of COVID-19 tests and collection kits all feature convenient, pain free, self-collection and can help increase access to testing, alleviate the burden on the health care system, minimize exposure risk to health care workers and can serve much needed PPE. While the progress on vaccines is welcomed and encouraging, vaccines alone will not be the silver bullet that solves the COVID-19 pandemic. The success of a vaccine program will depend on overcoming complex global production, logistical and public health education challenges. As we're beginning to see, these challenges are significant. Consequently, testing will remain a critical component for managing the spread of this virus for the foreseeable future. We believe there is plenty of room in the market. In December, the Rockefeller Foundation report called for 300 million tests per month, and that's just to safely reopen America's public schools. Globally, this number could be much higher. Multiple tests from multiple manufacturers will be required to meet the massive global need. We're confident in our position, given our wealth of experience and our legacy in developing and scaling rapid test for viruses including HIV, HCV and Ebola, and our strong track record of working with regulators to successfully bring them to market. Remember, our in-home over-the-counter, self-test for HIV was the first test of its kind for infectious disease that's approved by the FDA. Let's take a closer look at our COVID activities, starting with our molecular sample collection kits on Slide 7. As I previously mentioned, our sample collection devices are already being used for COVID-19 molecular testing and have generated $27 million in COVID-19 related sales through the third quarter of 2020. They offer all in one, easy, reliable and noninvasive self-collection of oral fluid samples. And preserve high-quality DNA and RNA with ambient temperature stability. Saliva has been demonstrated to be an effective sample for molecular testing and self-collection of COVID-19 samples supports social distancing, helps keep health care workers safe and concerns PPE. Two of our sample collection devices ORAcollect RNA and OMNIgene Oral received EUAs from the FDA in October. Our collection kits are also included in 7 customer EUAs and lab-validated workflows and are incorporated into back-to-school and back-to-work programs nationwide. Our sample collection kits are included in tests available at Albertsons pharmacies and at Costco. Moreover, we were delighted when Time magazine included OMNIgene Oral on its list of best inventions of 2020. As the need for testing continues unabated, we believe the expanded use of our molecular collection products shows great promise. Turning to Slide 8. OraSure is in the final stages of developing a rapid antigen test that, subject to receipt -- of emergency use authorization from the FDA would be -- would test for active COVID-19 infections using nasal samples self-collected from the lower nostril. As we've learned from our in-home HIV test, simplicity and ease of use are paramount when it comes to self-test. Our COVID-19 rapid antigen self-test is designed to be performed anytime, anywhere with no app, instrumentation, batteries or laboratory analyses needed to interpret the results. Essentially, it's a lab on a swab. The workflow is very straightforward with one step from swab to result. The user would simply collect a sample and insert the swab into a buffer solution. This visually read test is very similar to an at-home pregnancy test with 2 lines indicating a positive result and 1 line indicating a negative result. By contrast, other antigen tests require instrumentation or multiple precise steps to achieve claim sensitivity and specificity. Turning to Slide 9, subject to an FDA EUA, we intend to introduce our antigen tests to the market in 3 stages: a professional use test for use in clinical and nonclinical settings; a prescription self-test for use by individuals, employers, universities and public health; and over-the-counter self-test for use by consumers without a prescription. We expect to apply for the first EUA in the first quarter of 2021. Once approved, our test would enable fast, frequent testing that provides results in minutes, not hours, and would offer real-time information about whether an individual is currently infectious and contagious. Our OraQuick platform is scalable to millions of tests worldwide. Turning to our antibody test on Slide 10, we have developed an enzyme-linked immunosorbent assay, or ELISA, for the detection of human anti-SARS-CoV-2 antibodies that uses oral fluids as a sample. To date, there are no oral fluid COVID-19 antibody test. Ours has the potential to be the first. Antibody tests are well suited for community surveillance and 0 prevalence studies to identify people who have antibodies against COVID-19. Oral sample collection is quick, painless, noninvasive and requires less human contact than a blood draw, minimizing the need for personal protective equipment and reducing exposure to potentially infected patients. We are working with FDA to bring this test to market. Looking to Slide 11. Let me now turn to manufacturing capacity, where we're investing to significantly expand the number of tests and collection devices we're able to provide to help combat the pandemic and meet this unprecedented demand. As outlined here, we've already begun the process of expanding our manufacturing capacity for our COVID-19 tests and collection kits, and we intend to continue that expansion far into 2021. We're essentially planning to double our capacity for products over the year. We're also investigating possibilities of partnering with others or sub-licensing to third parties to further expand our ability to meet anticipated demands in all areas, which would add the capacity that I just outlined. I'd also like to briefly touch on some of the components of our non-COVID-19 business, starting with our HIV test on Slide 12. As we note, testing is critical to identifying HIV positive patients and linking them to care. An estimated 38 million people have HIV, yet 21% of them do not know their status. As I noted earlier, OraSure is -- has the first and only rapid HIV in-home test approved by the FDA and the first and only World Health Organization prequalified rapid oral HIV self-test. These simple, easy to use and easy to deliver oral fluid kits can deliver results in 20 minutes, helping to link patients to care. We are the leading player in international HIV self-test with significant market share. International sales of our OraQuick HIV Self-Test increased 17% in the third quarter of 2020 compared to the third quarter of 2019, largely due to higher sales in Africa. More than 2/3 of all people living with HIV are in sub-Saharan Africa. We see opportunities in Africa, Europe, Eastern Europe, Central Asia, Latin America as well as domestically. Turning to Slide 13, the federal government's initiative, Ending the HIV Epidemic: A Plan for America, has set a bold goal of ending the HIV epidemic in the United States by 2030. We've been encouraged to see proposals to significantly increase federal funding for the initiative in fiscal year 2021. Reaching the difficult-to-reach populations will be key to achieving this goal. Rapid testing that can be brought into the communities is seen as an important tool, with the FDA's only approved in-home or self-test in the market, OraSure is well positioned to play a key role in the Plan for America and capitalize on the market opportunities it represents. It's important that the HIV self-testing continues despite COVID-19. We've seen many public health departments increase purchases of our FDA-approved in-home HIV test in order to enable their clients to continue HIV testing without having to come to a clinic. In fact, CDC and other government agencies have encouraged health departments at all levels to consider HIV self-testing as an additional testing strategy to reach persons most affected. This speaks to the usability and convenience of our at-home test and allows individuals to test themselves and receive the results by themselves at home. Turning to our molecular business on Slide 14. Our DNA Genotek subsidiary is a pioneer in DNA and RNA sample collection, stabilization and preparation products. As Time magazine noted, DNA Genotek has done for DNA collection, what Google has done for web searches, made it ridiculously simple and efficient. I've talked about how our collection kits are being used for molecular testing for COVID-19. Our innovative sample collection technology, which stabilizes human DNA for long periods of time at ambient temperatures, was originally developed to help study the human genome. Our technology provides the magic behind human genomics, just like Intel is the magic behind personal computers. Turning now to Slide 15. The microbiome is made up of trillions of microorganisms that live on us and in us. We've leveraged DNA Genotek's expertise in developing saliva collection and stabilization devices for the human genome to develop easy-to-use technology to snapshot the ever-changing microbiome. Our collection tools help researchers explore the changes in the microbiome and the implications for nutrition, disease, therapeutic interventions, lifestyle and even longevity. While the microbiome is a relatively new field and a longer-term focus of our business, we believe there is significant potential. Prior to the pandemic, multiple research reports projected a compounded annual growth rate of 16% for the microbiome markets from 2019 to 2024. And thanks to our acquisitions of microbiome services companies, CoreBiome and Diversigen, which now operate under the Diversigen brand, we are able to offer end-to-end microbiome solutions all the way from sample collection to analysis. Our customers include academic researchers and pharmaceutical companies that are developing therapeutics for Crohn's disease, colitis and irritable bowel syndrome. We see great promise in this area. As we look further into the future, we see an opportunity beyond our genomic and microbiome businesses in the broader field of multiomics, which is illustrated on Slide 16, which offers a multifactorial examination of an individual's health. Scientists can look at multiple omes, such as a genome and the microbiome simultaneously. This multilayered view can generate new understanding of the pathology of numerous diseases such as obesity, diabetes, Parkinson's, autism and cancer. Before I close, I'd like to touch briefly on business development on Slide 17, where we are using our robust balance sheet to create revenue and shareholder value. COVID-19 has certainly complicated the business development picture, but we are continuing to see acquisitions that are accretive to our innovation growth strategy. On Slide 18, in closing, our business momentum is strong we expect that trend to continue. We see COVID-19 testing as a robust part of our business for now and the foreseeable future. With molecular collection devices already driving significant revenue and our antibody antigen test on the road to commercialization, OraSure is poised for continued and sustained growth. Our work with COVID-19 will help accelerate our growth significantly and we expect to emerge from the pandemic a stronger and larger company. With that, I thank you for your attention, and I'm happy to take some of your questions. Tycho?

Great. Thanks, Stephen. Maybe just I'll start off on the time lines around the OTC antigen test. Can you just kind of confirm you're still tracking toward their first quarter EUA submission for professional use? And then also, you've noted that the prescription at home of an OTC submission will shortly follow suit. So maybe just update on time lines there.

Yes. You -- the time line that you noted is still within sights. We feel very confident about that. And what we've been working towards, Tycho, is compressing the time lag between each of those submissions. And so we're hoping to get to ultimately OTC self-test as soon as possible.

And what are some of the details involved in the antigen test clinical trials that will allow for that transition from professional EUA to OTC EUA?

That's the -- those are the step minimizations that I'm talking about. So there are several steps and different requirements for each of the EUAs, among them usability studies for self-test as well as testing for asymptomatic patients. And all of those are in our protocol designs and are ready to be implemented.

I know Tim Stenzel and others at FDA have been very active in trying to get more at-home tests approved. We saw Lucira, Abbott. Maybe just touch a little bit on how you think about the competitive dynamics in the at-home setting? And do you think the majority of the market kind of shifts this way from centralized testing over time?

Well, I believe we're going to get more than our fair share of business because our test design is, as I've noted in the presentation, a one-step test. I think there's a very high probability that there will be several winners amongst test makers that are looking at self-tests, much in the same way that there are going to be several winners in the vaccine development and implementation front. There's just, I think, pent-up demand in the marketplace for self-test overall. That Rockefeller study that I mentioned that looks at 300 million tests per day in order to get kids back-to-school is noteworthy because not any single or several diagnostic companies could provide that volume of test. And so there is extremely high demand.

So are you -- will you be negotiating like with some of these kind of larger populations, school districts and others that would kind of want to broadly adopt? Is that part of the strategy?

It is part of the strategy, and we've already received inbound interest from large employer groups from K-12 to higher education groups as well as state governments. I think the incoming administration and its prioritized testing as well as the vaccine will help better coordinate our efforts here. And make sure that we get tests to the people that need them faster.

How about -- in terms of requirements, you -- in one of your slides, you mentioned airlines, entertainment venues. I mean to what degree do you think you're going to actually see stricter requirements of testing before you get on a flight, before you go into a concert?

I think that's actually the only way we're going to be able to gather in mass. And hopefully, at some point, without masks and shoulder to shoulder, which is the way we're used to getting together, right? But that's only going to be enabled by increasing herd immunity through the vaccine and also through vigilant testing to make sure that nobody is infectious at that event. And so we see a huge market in that regard to getting us back to normal whether it's travel or entertainment or employer groups or K-12 or higher education, all those are large buying groups in large markets.

Obviously, as the virus is mutated, there's a lot of focus on newer strains. What's your kind of strategy there to incorporate some of the newer strains that are emerging in South Africa and then otherwise?

Yes. I think this is a natural consequence of the virus being as infective as it is. And humans are very efficient bioreactors for mutation, and we're seeing that play out. So far, none of that has affected the target antigen, which we're using for our test. But we're going to be extremely vigilant to make sure that, that remains the case. And also prepare backup plans if we need different antigens to be deployed for the test. So I think you're right to note that recent development, and we're on it.

There was recent news, I think as Buffalo Bills that required people to take a test before they went into the stadium, but it was a PCR test in a centralized fashion. I mean how do you think about that dynamic given some of the bad press antigen testing has received overall?

Well, I think we're just not accustomed to the notion of precise tests that are used infrequently and rapid tests that are used frequently. And that's because they've just not been widely deployed. So you hear voices in the wilderness, like Michael Mina, talking about fast and frequent testing and the need to have an A test and a B test so you can validate if you're truly positive. So I think that dynamic will play out. And that really does speak for the fact that we need multiple rapid antigen tests in the market and also a backup plan with molecular tests to be used on occasion. So I think that the scenario that you mentioned with the Buffalo Bills will play out more often and at larger scale once we have more rapid antigen tests.

Do you see a bigger opportunity outside the U.S. for the rapid antigen test, like the rapid HIV test?

We do. And I think that's when our -- where our expertise and the hard work we've done to open up markets in low and middle-income countries around the world for HIV self-test will serve us well. The most recent reports are that low and middle-income countries will not receive the vaccination in a widespread way for several years now. And that's just because of the buying habits of the more sophisticated economies as well as just the shortage overall to get to these populations that can only afford it with government buying. So I think we play very strongly into that area, and that's why we see the COVID-19 opportunities, particularly the rapid antigen test to be durable over many years, perhaps as long as 2025.

You touched on your plans to kind of scale capacity from 35 million tests per year now. I mean do you assume you can sell everything you can make over the next year?

I think that is the plan, and I think we are approaching that, certainly for the molecular collection devices, if we ramp up supply there. But we've done the calculation very carefully on the expansion to make sure that we're making sound financial and economic decisions. But that is -- I think that is in the works very soon.

And what's your view of what the tail of testing looks like into 2022 and beyond?

Well, I think we'll move from the pandemic to the endemic phase and the need to test frequently will go above and beyond what we've seen for the seasonal flu. And the need to have tests available to continue to test for COVID-19 will last well beyond 2022, certainly in the sophisticated economies. And then for the low and middle income countries, perhaps well into 2027 or 2030, unfortunately. But I think that's the state of play for this virus and the world populations.

And then just kind of rounding it out on the portfolio, the PCR collection devices for saliva oral fluid. They've seen a nice step up. Just an anecdote, we're using them at JPMorgan for our send out tests. So great to see that. How do you think about scaling that up and where the incremental demand there comes from?

Well, first of all, thank you for being a customer. We really appreciate it. We see the step-up continue to happen. So I mentioned that we sold 27 -- over $27 million in sales through the third quarter. And we're seeing demand building for 2021 and beyond. And it just turns out that saliva is really the preferred way to sample folks because they can do it on their own. You don't have to consume health care resources, whether it's health care workers, time and effort or their risk or PPE or swabs. These can all be avoided by using a self-collection saliva kit. So I think we are seeing strong demand through 2021, but even beyond that, based on the needs of reopening.

Yes. So I mean, I guess, how much upside do you expect in the near term as cases are going up pretty quickly around the collection kits?

Well, I think that we're forecasting 2021 to be a major step-up over 2020. We already did $27 million up to the third quarter last year. So -- and that's the whole rationale, by the way, by our manufacturing capacity expansion and even our further look at expansion beyond that in other facilities.

How about kind of nasal saliva, that debate, any pushback around doing saliva over nasal from your perspective?

Well, saliva is a tremendous analyte for molecular tests, and that's been proven. Obviously, JPMorgan thinks so in utilizing our kits. For the antigen test, we found that the best reservoir is actually the nose. And remembering that the difference between antigen test and molecular test is there's no amplification for antigen test. And so they need to find the reservoir where the virus exists, makes sense for it to be the nose. For our antibody test, which would, at current course and speed, be the first oral fluid-based antibody test on the market. It turns out saliva and oral fluids are great analyte. Much of saliva, I think, as you know, is either water or white blood cells. And so you're going to have a strong correlation to the immunochemistry you need to make ELISA assays work.

And then what do you see is the role of your antibody test? Why is the need to do it in a decentralized fashion? Why do you need quicker turnaround time? How do you think about the competitive test from other competitive threat from other serology tests or T cell COVID tests, things like that?

Yes. It turns out that there are over 300 tests on the market that the FDA has put on the mark -- is permitted on the market with EUAs. Many are rapid tests, ours is a lab-based test. But the key point is that all of them are blood-based tests. And so as we think about surveillance and seroprevalence, enabled largely by the vaccine, we're going to need to figure out whether we're reaching herd immunity and quantify that. And so the combination of our oral fluid collection kit with our ELISA-based assay will qualitatively let you know who has antibodies in a population. There will probably be next-generation products that are -- have differentiated between IgM, IgA and IgG fractions as well as quantify those fractions towards better characterization of herd immunity. But I think it will become a valuable tool for public health officials and policymakers to determine which parts of the countries or which part of the world have reached harder immunity and therefore, can get back to normal more quickly. And also enable travel between those sites.

And how do you get people to take an antibody test? I mean it's hard enough to get enough people to take a COVID test and a vaccine, of course, so what would be kind of the motivating factor? I mean do you think employers would require it of employees or payers will require it? What's the driving force for people to actually go out and do an antibody test?

Well, I think if the carrot is, you get back to normal life faster, I think we can all subscribe to that. And so I think that perhaps one of the biggest misnomers about the vaccine is even with the widespread vaccine, we're still going to have to wear mask and social distance until we're convinced we've reached herd immunity. And so the carrot is, once a community has reached herd immunity, we can more or less go back to normal. And I'm hoping we can find motivating factors either through employers or incentives or public health officials to get us there. But what makes our product for antibody testing so special is it's an oral fluid-based test. And so you could conceivably self-administer it with the proper approval, and you don't have to draw blood to take the test. And I think what we've learned through our human genomics work is that people are much more likely to subscribe and enroll in these studies faster and at higher numbers if they can simply provide saliva and oral fluid versus blood. I think that's the key to a widespread adoption of an antibody test.

Maybe last one on COVID and then I want to hit on the rest of the business. But for the international market, do you expect some sort of subsidy like you have with the Bill & Melinda Gates Foundation for HIV or...

I think that, that would be extremely helpful if the global consortium took on some of the practices they've used for eradicating HIV, some of which involve subsidy of products like ours. But I think what -- it's also incumbent on us to create flexibility in pricing through COGS reduction, and that's what we've set out to do also. We set out to do that for our HIV product line and because the manufacturing lines we're commissioning for COVID-19 are essentially the same setups, I think we can envision the same economies of scale and cost reduction as well.

Maybe shifting to the base business then. In infectious disease, can you just talk a little bit about both international and U.S. trends in HIV. International has held up actually okay during the pandemic. It was double digit, still doable this year? And then how do you think about the U.S. market?

Well, we were up 17% in the third quarter versus third quarter 2019 for international HIV. We are impressed by the growth in spite of the pandemic. But I think what it demonstrates is that when you have political and economic will to eradicate disease, testing is a major enabler. So we've seen that in sub-Saharan Africa, in particular. So I hope that translates well for COVID. The rest of the base business, I think, has, in some ways, been affected by the pandemic. Certainly, in the domestic front, with clinics closed, our HIV professional test, sales were off there. Offset a bit by the sales of HIV self-tests, as I mentioned in my remarks, because without clinics open, the only way to get to people is for them to self-test. The collateral damage of the opioid crisis here in the U.S. has caused a rise in HIV and HCV. The plan for America ending the HIV epidemic had the fundamentals in place for us to grow off of that base, both for HIV and HCV. And eventually, I think we'll return to those growth rates.

How about the molecular collections business, commercial traction has been strong for genomic kits. As we think about academic labs and POPSEQ and some of these other programs getting back up and running, are you seeing an acceleration there?

I think we will see, we haven't seen it yet. Interestingly enough, many of the companies involved in population sequencing turned their attention towards COVID-19 during the pandemic. And so you see a shift in business focus there. But ultimately, the need for genomic testing to determine health risks, let's say, cancer biomarkers within your genome and monitor those over time are going to be extremely important. So that hasn't changed in terms of the need to have that knowledge. I think it's just been paused because of the pandemic. So we see strong growth in that sector in particular. I think we've also seen surprising resiliency in the ancestry and heritage piece of consumer genomics as well. That's probably enabled by the fact that people are spending a lot of time at home and are looking for things to do. We even see an uptick, by the way, in the testing for canine genomes because of the number of dogs that have been adopted during the pandemic, and people are curious about their lineage. So it's not all bad for the stay-at-home pandemic world, at least, as it affects OraSure.

Can you maybe touch on the integration of Diversigen and CoreBiome in terms of kind of cross-selling with the legacy molecular collections business?

Yes. That integration has gone extremely well. And I really have to thank our employees in Diversigen and CoreBiome who brought those companies together in the midst of the pandemic. We moved from 2 separate facilities, one in St. Paul, Minnesota and the other in Houston, Texas, a brand-new facility that will provide economies of scale for both operations. We're trading under the Diversigen brand, but we're powered by CoreBiome's exceptional analytical engine and artificial intelligence engine behind it. So that's gone -- that's one of the key bright spots and what's happened during the pandemic is staying on track with that consolidation and operation in consolidating the brands.

I'm going to maybe ask a couple from Roberto, put him in the hot seat for a minute here. Curious about the margin line, how you think about the gives and takes as the lab services business becomes a larger portion of the revenue mix? And what are the optimal gross margins for legacy OraSure and then DNAG business, product line, ex COVID?

Sure. So historically, the gross margin percentages for the legacy business on the diagnostics side have been on the order of 55% to 60% and DNA Genotek on the order of 60% to 65%. That's before the addition of the microbiome services. Services businesses typically have lower gross margin percentages. So as that business grows, we expect that to take the margin on the DNA Genotek side down a bit. That said, for the COVID-19 opportunities, we are seeing that leveraging our existing COGS infrastructure, getting savings from manufacturing and then bulk purchasing of raw materials means that the COVID-19 products are likely to be higher gross margin products. So over the next couple of years, because the growth of those will be far in excess of the growth of microbiome services, we do expect to see some benefit to the gross margin percentage that could then persist beyond the next couple of years.

And then how about dropping it through to operating margin? What sort of OpEx investments do you need to kind of scale up and accelerate, particularly on the molecular collection side? Or how much actually you think will drop through?

So on molecular collection, we expect to see benefits from growth in revenues there. It's largely lab workers. And so as long as you can put more products, more samples through, we'll see operational benefits. As far as the COVID-19 opportunities, those are driven largely by large bulk purchasers. So growth in sales and marketing is likely to be much lower than the growth in revenues that we'll see there. And the R&D investment has already occurred. So we see some good opportunities to leverage on the bottom line with the growth in revenues that we're going to be seeing.

And then capital deployment, M&A has obviously been a big part of the story. How are you feeling about the current funnel, seller expectations? Is this going to be a big year for bolt-on deals? Or what's your view?

Well, the pipeline has never been fuller in terms of opportunities, particularly inbound opportunities. And Tycho, we've maintained, we will do the right deal at the right time with the right valuation. The valuations are interesting these days, particularly those companies that have some sort of COVID focus. So we're being very disciplined in the way we look at those type of opportunities. And then really what we're trying to avoid is sort of the bubble mentality about COVID-19 and sort of racing to get -- to consolidate assets and resources that serve only 1 purpose. If they can serve more than 1 purpose and give us adjacencies and multiplex opportunities, we can certainly look at those as well. But it's been an interesting environment. Lots of inbound activity. I think we are actively in the market of doing deals. That's why we did the capital raise last year. That's why our balance sheet is $264 million in cash and no debt. But we'll also be careful because due diligence itself is rather interesting in the pandemic without the usual amount of contact with the principles. So all in, I think we remain very optimistic based on our own initiatives and the inbound interest that we've received in companies that want to work with us.

Is it fair to say strategically you would stick with infectious disease, sample collection, microbiome, some of these kind of areas you already have a big presence in? Or would you cast a wider net?

Well, our balance sheet gives us a lot of optionality. And so I think that our first preference would be to make sure it's adjacent to our current business units and adjacent to our expertise. But we are also in the market for more transformative acquisitions or mergers as well that might create bigger, stronger entities as a result of those. So everything is on the table as far as the pipeline and then discernment and due diligence and analysis come very soon behind that.

Great. Well, we hit the top of the session. So I want to thank you both for taking the time. It was a great overview. Enjoy the rest of the conference and talk to you soon.

Thank you, Tycho. It's been our pleasure.

Thank you, Tycho.