OraSure Technologies, Inc. (NASDAQ:OSUR) Q4 2020 Earnings Conference Call March 1, 2021 5:00 PM ET
Jeanne Mell - Vice President of Corporate Communications
Stephen Tang - President & Chief Executive Officer
Roberto Cuca - Chief Financial Officer
Conference Call Participants
Vijay Kumar - Evercore ISI
Casey Woodring - JPMorgan
Patrick Donnelly - Citi
Andrew Cooper - Raymond James
Frank Takkinen - Lake Street Capital
Good afternoon, everyone, and welcome to the OraSure Technologies 2020 Fourth Quarter and Full Year Financial Results Conference Call and Simultaneous Webcast. As a reminder, today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be question-and-answer period. [Operator Instructions]
I would now like to turn the call over to Jeanne Mell, Vice President of Corporate Communications for OraSure. Jeanne?
Thank you, operator. With us today are Dr. Stephen Tang, President and Chief Executive Officer; and Mr. Roberto Cuca, Chief Financial Officer. Dr. Tang and Mr. Cuca will begin with opening statements, which will be followed by the question-and-answer session.
Before I turn the call over to Dr. Tang, you should know that, this call may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share and other financial performance, product development, performance, shipments and markets, business plans, regulatory filings and approvals, expectations and strategies.
Actual results could be significantly different. Factors that could affect results are discussed more fully in the company's SEC filings, including its registration statements its annual report on Form 10-K for the year ended December 31, 2020, its quarterly reports on Form 10-Q and its other SEC filings. Although, forward-looking statements help to provide complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today. The company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call.
With that, I will turn the call over to Dr. Stephen Tang.
Thank you, Jeanne, and thank you everyone for joining us today. I hope you and your families are safe and well. As you will hear today, OraSure continues to successfully navigate the COVID-19 pandemic. Today, we reported record-breaking fourth quarter and double-digit full year revenue growth, driven by our sales of our molecular sample collection kits for COVID-19 testing. In addition, our base business was resilient, with demonstrated strength in sales of our international HIV testing products, which also grew by double digits year-over-year and strong genomics growth in key customers in our disease risk management and companion animal segments.
We expect our role in COVID-19 detection to only grow in importance as we've made substantial progress in our rapid antigen self-test for COVID-19. We have locked the proprietary assay chemistry, and completed development, and completed clinical testing. I'm delighted that, we were able to accelerate the clinical trials for the prescription self-test, and now plan to submit for Emergency Use Authorization or EUA, for both a prescription self-test and a professional self-test by the end of the month.
We also remain on track to resubmit two separate EUAs for our lab-based oral fluid antibody test and look forward to bringing this pioneering product to market as soon as possible. Revenue from our sample collection kits for COVID-19 molecular testing continues to meaningfully contribute to our business, with full year revenue from those kits totaling $50 million.
In the fourth quarter, net revenues of $62.9 million represent the highest quarterly revenue performance in OraSure's history driven by $22.5 million in sales of our COVID-19 molecular sample collection kits in that quarter. We expect this strong sustained performance to persist as testing remains a key strategy to combat the pandemic. Here in the US, the Biden administration has called for more broad testing to turn the tide of the pandemic and proposes dedicating $50 billion in spending to testing.
A December Rockefeller Foundation report calls for 300 million tests per month and that's just to safely reopen America's public schools and keep them open. Globally, this number will likely be much larger, because vaccines will not be widely available in much of the world. Multiple tests from multiple manufacturers will be required to meet the massive global need. The emergence of new more contagious variants of the coronavirus underscores the importance of testing as a means to detect infection, especially as the rollout of vaccines encounters logistical hurdles.
Dr. Anthony Fauci has said that we will reach herd immunity when 70% to 85% of the population is vaccinated. Currently less than 10% of the US population is fully vaccinated. Globally, the number is far less. And as COVID-19 moves from a pandemic to an endemic disease, we believe people will still need to know their status and test regularly making testing an important part of overall disease management. Also as the virus mutates, surveillance or the genetic sequencing of samples for variant identification will become an increasingly important part of our global coronavirus response plan. We join our industry peers and public officials who believe that testing will remain a key part of our return to normal life of unrestricted gathering and travel even with widespread vaccination.
Against that backdrop, OraSure continues to advance its three distinct COVID-19 opportunities: sample collection for molecular testing and surveillance; an easy-to-use rapid antigen self-test; and a lab-based oral fluid antibody test each of which will help accelerate OraSure's growth. Our portfolio of COVID-19 tests and collection kits all feature convenient, pain free, self-collection and can help improve access to testing alleviate the burden on the health care system, minimize exposure risk and conserve personnel protective equipment or PPE. The momentum we've seen from our molecular COVID-19 sales significantly outweighs the challenges that the pandemic presents to other areas of our business. We expect that once commercialized, our antigen and antibody tests will accelerate our record-breaking growth.
Use of DNA Genotek molecular sample collection kits continues to grow in back-to-work settings, back-to-school programs, laboratory testing and direct-to-consumer offerings. We are encouraged by the high-volume repeat orders from existing customers as well as demand from new customers. To date, our molecular collection kits are now included in eight EUAs granted by the US Food and Drug Administration to DNA Genotek's customers. We've also received our own FDA EUAs for the use of our OMNIgene ORAL, an ORAcollect RNA collection devices in COVID-19 testing, which allows for the unsupervised use of these devices at home or in health care settings when used as part of an approved or validated at-home test kit.
In February, State University of New York announced that their campuses have administered more than one million COVID-19 tests since the start of the 2020-2021 academic year. These tests were developed by a DNA Genotek customer Quadrant Biosciences and uses our ORAcollect RNA collection device. And Clinical Reference Lab has announced that their CRL Rapid Response COVID-19 saliva test, which uses the OMNIgene ORAL collection device is now available through Walgreens Find Care digital health platform.
Internationally, the OMNIgene ORAL is being utilized as a collection device by Chronomics for the UK government's Test to Release for International Travel COVID-19 testing program, which was announced in January. In addition both the OMNIgene ORAL and ORAcollect RNA saliva collection devices received interim authorization for use in COVID-19 testing from Health Canada in January. This enables diagnostic labs, health authorities and COVID-19 test kit providers across Canada to offer self-collection both at-home and via health care professionals. These authorizations could be transformative for public health efforts in Canada by adding important tools to increase access to testing. Also of note, OMNIgene ORAL was included in Time magazine's roundup of the best inventions of 2020.
Turning to our diagnostic test for COVID-19, OraSure continues to make substantial progress on the development of our COVID-19 rapid antigen self-test. Subject to regulatory authorization, our rapid antigen self-test would detect COVID-19 infection using nasal samples self-collected from the lower nostril. As we've learned from our HIV test, simplicity and ease of use are paramount when it comes to self-test.
Our COVID-19 rapid antigen test requires no instrumentation, batteries or smartphone. Users would simply swab their nostrils, swirl the swab and buffer solution and see the result. As I noted earlier, we have finalized product development and completed the clinical studies necessary to submit both the professional version and the prescription self-test version in Q1. We are pleased that the clinical trial results validate our commitment to meeting the high standards we have set for ourselves.
The self-test market represents a significant opportunity for COVID-19 testing. And as of Friday, only three self-tests have been authorized by the FDA. Subject to regulatory approvals, we intend to market the prescription self-tests for use by individual consumers with a prescription at-home or in any location by employers and universities on or off-site, or by physicians, or public health authorities via remote testing and the professional tests for use at drive-through sites physician offices, public health testing sites and employer or university health centers.
In addition, we intend to continue our plans to pursue an over-the-counter claim with the additional clinical testing required. We are also planning to launch our rapid antigen test outside the US as we anticipate the COVID-19 diagnostic testing market will shift to international markets as US vaccination advances.
Moving on to our third COVID-19 opportunity, our lab-based oral fluid antibody ELISA test. Antibody tests are becoming more important as vaccines rollout and the focus on herd immunity increases. Our test has the potential to be the first antibody test authorized by the FDA that uses oral fluid samples. This is an important distinction. Oral fluid samples are easy for individuals to collect. They minimize health care professionals' need for PPE and reduce the exposure to potentially infected patients as compared to blood draws.
OraSure's test has been shown in a peer-reviewed clinical study to increase the ability of antibody tests by 25-fold versus blood-based testing. In addition in this study, the OraSure oral fluid SARS-CoV-2 antibody test was shown to have a 90.9% positive percent agreement and 100% negative percent agreement versus serology.
With this test individuals would use a collection pad to self-collect an oral fluid sample under the observation of a health care professional. The sample would then be placed in the OraSure oral antibody collection device buffer for storage and transport. It will then later be dispensed onto the OraSure ELISA microplate for testing in a laboratory. This lab-based antibody test can aid in identifying individuals with an adaptive immune response to SARS-CoV-2 indicating prior infection. The test could also aid health officials in community surveillance efforts and seroprevalence studies.
At the request of the FDA, we plan to resubmit two separate EUAs for the test: one covering the oral fluid specimen collector; and one for the microplate assay. In addition, the FDA has requested additional analytical studies be conducted on sample collection and stability. These studies are in process and we plan to file the EUAs for this pioneering product as soon as the studies are completed.
Meanwhile, we continue to sell our antibody tests for research use only. This has led to interest from several companies and labs that are conducting seroprevalence studies. In addition, our antibody test is being used in studies that are looking at vaccine response. We expect that the antibody testing will become more important as the vaccine rollout continues both to determine vaccine longevity and measure progress towards herd immunity.
I'd also like to touch on our ongoing manufacturing capacity expansion efforts, which continue on schedule for all of our COVID-19 activities. In addition, we now plan to add capacity for an additional 50 million rapid antigen self-tests bringing capacity to 120 million tests per year by the second quarter of 2022. This additional capacity is intended to support sales outside the US included in these numbers are approximately 17 million of our existing tests for HIV, HCV and Ebola.
Before I turn the call over to Roberto for a report on our fourth quarter and year-end financials, I'd like to note that we are encouraged by the Biden administration's stated commitment to a scientific, organized and centralized approach to COVID-19 testing in the US.
We especially welcome the administration's focus on rapid tests and the proposed $50 billion investment to increase the nation's testing capacity. This underscores the durability of our COVID-19 testing opportunities and aligns with our motivation to ensure simple, safe and rapid testing is widely available.
And with that, I'll hand it over to Roberto for a report on the financials. Roberto?
Thank you, Steve. As Steve mentioned earlier, our fourth quarter net revenues increased 27% to $62.9 million from the $49.7 million reported in the fourth quarter of 2019, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing and increased international sales of the company's HIV self-test. This was partially offset by lower sales across all of our other product lines, primarily due to the impact of the COVID-19 pandemic as well as a shift in the ordering patterns of a large genomics customer.
Net product and services revenues were $60.4 million, a 28% increase from the fourth quarter of 2019. Total product and service revenues for the company's molecular business unit were $40.3 million during the fourth quarter of 2020, an increase of 58% from the fourth quarter of 2019. This increase included $22.5 million in sales of oral fluid sample collection devices for COVID-19 molecular testing, which was partially offset by a decrease in genomics and laboratory services sales.
International sales of the company's OraQuick HIV tests, increased 16% compared to the fourth quarter of 2019 largely due to higher sales of our HIV self-test into Africa. Gross profit percentage was 61% for the three months ended December 31, 2020 compared to 60% in the same period of 2019 due to an improved product mix of higher gross profit percentage product sales.
Net income for the fourth quarter of 2020 was $1.9 million or $0.03 per share on a fully diluted basis compared to net income of $2.4 million or $0.04 per share on a fully diluted basis for the fourth quarter of 2019. Fourth quarter 2020 results included a benefit of $1.5 million for the change in the estimated fair value of our acquisition-related contingent consideration compared to a charge recorded in the fourth quarter of 2019 of $179,000.
2020 results also reflect the additional product development costs incurred for our COVID-19 tests as well as increased foreign tax expense associated with the improved results of our Canadian subsidiary. Cash and investments totaled $257.1 million at December 31 2020.
As we disclosed in our press release, we expect revenues of $55 million to $60 million in the first quarter of 2021. We are not providing full year guidance at this time, but we'll revisit that option as we get greater clarity on the regulatory status of our COVID-19 antigen and antibody tests.
With that, I'll turn the call back to Steve.
Thank you, Roberto. I would now like to provide some brief updates on our legacy businesses, which continue to show resiliency in the face of the challenges of a pandemic. Access to HIV testing continues to be challenging in this pandemic and self-testing is a convenient solution that enables social distancing and helps minimize COVID-19 exposure.
This past quarter, we ensured continued access to rapid convenient HIV testing both domestically and internationally. HIV OTC and self-tests continue to show strength and offset declines in professional testing due to the COVID-19-related clinic closures, which were seen across the US, Korea and the European Union.
We were encouraged by robust international HIV self-test sales, which increased 16% over the same quarter in 2019 and for the full year. In Q4, OraSure sold over four million HIV self-tests outside the US as compared to 2.9 million self-tests in the fourth quarter of 2019. We expect this trend to continue.
Total diagnostic revenues were down 7% for the fourth quarter versus the fourth quarter of 2019 and down 8% for the full year period. However, it's important to note that the testing markets for HIV, HCV and risk assessment, which represents the vast majority of the diagnostic business unit has been stated by various sources as being down by as much as 50%.
Comparatively OraSure's diagnostic business unit showed strength a testament to OraSure's legacy of providing easy accurate answers to critical health questions.
On the molecular side, outside of COVID-19, we have expanded the scope and application of our genomics collection products through new regulatory clearances. The Oragene Dx saliva collection device was included as a component in the de novo FDA authorization granted to Helix for their whole exome sequencing platform. This is the first exome sequencing-based platform authorized by the FDA.
Oragene Dx was also included as a component in the 510(k) clearance Helix received for its Helix Genetic Health Risk App for a late onset Alzheimer's disease for over-the-counter use the first test to be cleared on the Helix Laboratory Platform.
As noted earlier, we saw growth with customers in disease risk management as saliva collection enabled ongoing genetic testing when blood collection became more difficult due to COVID-19 closures.
Additionally, the companion animal testing segment saw growth as pet adoptions rose double-digits during the quarantine. Our microbiome business held steady in Q4 with 3% growth over Q4 2019, driven by strong repeat business from our customers.
And as I announced on the third quarter call, we continue to build our multiomics strategy with new product introductions such as OMNImet GUT and OMNIgene SKIN, the first combined product service offerings with Diversigen.
Finally, before we move to Q&A, I'd like to provide some summarizing thoughts. Over the past year, we've seen further evidence that infectious disease testing and self-collection must meet customers wherever they are. OraSure is steadfastly focused on making COVID-19 detection simpler, faster, and smarter, putting the control in the hands of the individual.
The results of this past quarter make it clear that OraSure is well-positioned to assist in the battle against COVID-19 and the best is yet to come. Expected continued growth in COVID-19 molecular revenues into 2021, the planned introduction of our new rapid antigen and antibody tests and the ongoing expansion capacity to meet demand solidify our confidence that COVID-19 is a long-term substantial and sustainable opportunity.
Meanwhile, we remain optimistic for the resilience in the future of our legacy businesses as well as our journey towards multiomics. Our strong balance sheet bolstered by COVID-19 revenues will afford us the opportunity to maximize the COVID-19 market opportunity, fund our legacy businesses, and seek transformative and accretive business development opportunities.
We are confident that we will emerge from the pandemic a larger, stronger, and more innovative company able to effectively compete in key burgeoning markets in diagnostics and molecular solutions.
With that, operator, I'll turn the call over for questions.
[Operator Instructions] Our first question or comment comes from the line of Vijay Kumar from Evercore ISI. Your line is open.
Hey guys. Thanks for taking my question. Steve and Roberto congratulations on the progress you guys have made on the antigen testing. I had a few questions. I think the press release mentioned clinical studies are done. Could you perhaps comment on the performance of the test versus some of the other at-home tests which are out there in the market? And I think in the past, Steve, you've mentioned ease of use your test as being one step. So now that we know, what other tests are on the market, could you perhaps comment on whether your test will be the easiest one to use in the market?
Thank you, Vijay. We have made substantial progress. The clinical trials are complete. And right now, we are just completing the submission to the FDA for the EUA. So, you're right. I think the simplicity of use of our device where an individual simply has to swab their nostril, swirl it in a vial and then see the results remains one of its biggest advantages.
While we're not sharing specific performance data, we are very confident that we meet the requirements of the prescription self-test template. And those are very specific requirements by the FDA. So the use case for our product I think looks extremely promising even in the face of other products that are on the market right now. And as a reminder, there are still precious few tests -- self-tests that are on the market. There are only four that have been so far EUA-ed. So we are very encouraged by our prospects, both in performance and the commercial prospects for sales.
I guess on that point Stephen, manufacturing capacity was taken up to 120 million I think back to when we spoke about perhaps pricing coming down in the market. But this seems to be different, right as you guys are expressing optimism. How should we think about demand? Like do you have demand locked in for I guess 100 million antigen tests? And any comments on pricing?
Yes. So we don't have demand locked in, because we aren't able to market the product until we get the EUA. But we've had strong expressions of interest inbound from a number of different potential customers along the way. A lot of that as you can imagine Vijay was awaiting clinical data, which we can now provide to them under nondisclosure agreements. So, prospects look extremely good.
The additional capacity which we've announced which will bring us to 120 million units by the second quarter of 2022 are for outside the US And so I think our prospects outside the US are strong as well. As you know we have a legacy business in HIV self-tests outside the US which grew by 16% last year four million units we announced we sold in the fourth quarter last year. And that's a real springboard for us to address the needs of the low and middle-income countries around the world.
We're also exploring the high-income countries in the EU and elsewhere for market access and penetration for our products as well. But as you can imagine, our first task is to submit the EUA and obtain EUA from the FDA. And then we'll be looking at those clusters of opportunities as well. But suffice it to say, we are confident in our prospects. That's why we've upped our capacity to address the global needs as well as the domestic needs.
And just one last one for me, Stephen. It sounds like the step-up in capacity, manufacturing capacity, this is more driven by inbound customer interest. I want to make sure I heard that right. And then any comments on timing for over-the-counter test? Correct me if I'm wrong, but none of these tests on the market have an OTC label. Could you guys end up being the first with an OTC label?
Well, I think there was actually one with an OTC label but it's not widely available because manufacturing capacity has not yet been built for it. So I won't speak for them. But that does remain out there. Our plans for OTC are still there. I think we want to see the performance of our prescription self-test product in the marketplace. Of course, the biggest threshold for the OTC registration is asymptomatic patients. And so we want to be careful to design the studies in a way that shows off the performance of the product. So we haven't announced anything in terms of timing for OTC but it still is clearly in our plans.
Understood. Thank, guys.
Thank you. Our next question or comment comes from the line of Tycho Peterson from JPMorgan. Your line is open.
Hi, guys. This is Casey on for Tycho. Maybe can we just talk a little bit about the 1Q guidance. Specifically, what is baked in as far as COVID collection kit revenue in the 1Q guide? You guys mentioned that there were some significant opportunities that you received in 1Q as far as EUAs are concerned. So maybe just can we expect another sequential step-up there in 1Q? And then maybe talk a little bit about the cadence that you're expecting for those revenues throughout the year.
Sure, Casey. Thanks for the question. It's Roberto here. So we haven't provided additional granularity on the guidance. But I can give you the color that we do expect sequential growth in our COVID-19 molecular collection devices and that we also expect to see the sort of normal historical seasonality in some business lines that have occurred in prior years.
We're not providing guidance beyond the first quarter in part because of the uncertainty of some of the regulatory status of the products that we're applying for. But overall, given the way we're expanding capacity both on the antigen, antibody and collection devices sides or on all those sides, you can expect that we do expect to see growth persisting.
Got it. As far as what's needed for OTC submission, what's left in terms of clinical trial kind of data that you need for OTC? And we heard from one of your competitors that finding positive samples to run an OTC clinical trial has been a limiting factor as far as timing goes. Can you maybe talk about if you've been experiencing something similar, or can you maybe just talk a little bit about what you got – what's left for OTC approval?
Yes. So I can't obviously comment on someone else's EUA. But certainly, as I mentioned before, the requirements from the OTC EUA are that you provide data for asymptomatics. And so that is a key difference between the prescription self-test and the OTC template.
So that requires some additional attention on our part for that submission. But we plan on accounting for it. But as I said before, our first job is to get the Rx self-test through the EUA process and then go from there. So it is still in our plans but we haven't offered anything beyond that.
Okay. And then maybe just one last one for me. As far as the inbound interest that you commented on in the previous line of questions how – what percentage of those is from sort of large employer groups and schools versus customers that are – would be more long-term in their ordering patterns? Is it your expectation that you'll be selling into these large employer groups and schools past the height of your scale up in 2Q 2022? Maybe just talk a little bit about, yes, customers that you're talking to.
Yes. Certainly, Casey. So certainly, the inbound interest has come from employers education, both K-12 and higher education. And we expect the overall demand to be durable through 2022 in the US and then well beyond that outside the US. There are other buying groups that we're talking to as well, congregant living facilities including prisons and nursing homes that need to test routinely and quickly; entertainment and travel which will be needed to get people to essentially go wherever they want to go and travel wherever they want to travel.
So, I think many of these applications are going to be durable, particularly if you consider the fact that no country is an island unto themselves. In order to get back to normal, we're going to have to re-establish global travel and global trade. And that's going to depend on further testing, because the vaccine rollout will not be even across the world. Many countries won't receive the vaccine for several years, particularly the lower middle-income countries. So that's why we think it's a substantial sustainable opportunity for us for several years.
Okay, great. Thank you.
Thank you. Our next question or comment comes from the line of Jacob Johnson from Stephens Incorporated. Your line is open.
Hey, guys. This is Mason on for Jacob. Just a few quick ones from me. Any additional color you can provide on your FY 2020 collection kit sales, maybe the split between US versus OUS? And how do you expect that change to change or maybe shift in the upcoming year?
Steve, do you want me to take that?
Yes. Go ahead Roberto, please.
So Mason, just to clarify, do you mean collection kit sales specifically for COVID-19 or in general?
For COVID 2019, sorry.
Okay. Yes. So the majority of those collection kit sales were for use in the US with some smaller amount in Europe. We do expect that as we're still capacity constrained with those products, we'll be focusing on the US and then other higher-income countries, and then continue to roll those the sales of those products out to lower middle-income countries later in the year and in the coming years.
Got it. Thanks for that. And then, base business-wise, could you just update us on the trends you're seeing in some of your base businesses non-COVID businesses? Are those recovering, and any thoughts going into 2021?
Yes certainly. So led by our international HIV franchise, which grew by 16% in the fourth quarter and 16% year-over-year that was largely unabated by the pandemic. So, that's an extremely positive sign for us. So that segment doesn't need to recover. It simply needs to keep on growing.
The other areas which were affected by clinic closures not only in the US but the European Union places like South Korea, those are starting to recover. We noted in our remarks that even though our overall diagnostic revenue was down 7% in total for 2020 the testing markets that we participate in that's HIV, HCV and risk assessment testing, by some measures were down as much as 50% for the entire year. So I think we showed strong resiliency through 2020 and we're seeing signs of recovery already in the base businesses. So that's very positive.
And then on the molecular side, clearly, we saw a little bit of growth in the microbiome side that was affected in 2020 by closures of laboratories, university laboratories and also in the commercial settings. That's looking like it's starting to recover as well.
And disease risk management is starting to recover. And we saw even companion animal sample collection grow, because more people are adopting animals. So I think, we're seeing different signs for different reasons. And I think we are optimistic that a recovery has already begun and that we are participating in it.
Great. Thanks, guys.
Thank you. Our next question or comment comes from the line of Patrick Donnelly from Citi. Your line is open.
Hey. Thanks for taking the questions, guys. Stephen, maybe one for you, just on the international opportunity for COVID. Clearly, sounds like you guys view that as quite sizable and a pretty nice tail on the back end as well. Can you just talk through, I guess, the time line to get to those markets?
How are you going to play it out, again, region by region? Again, certainly, it sounds like U.S. is first. But then beyond that, I'm just kind of wondering how long it will take to get these products out there in the market on some of the different larger international opportunities.
Sure. Thanks for the question, Patrick. So, clearly, we understand the U.S. situation very well. We're looking at markets in the higher-income countries, including the European Union and the regulatory requirements specific there and what can be translated from our EUA filing for the prescription self-test.
For the low and middle-income countries, I think, we are, as you're aware, part of a global consortium for the eradication of HIV. And many of the same players in that will be the same players in commissioning diagnostic testing for COVID-19. It's the same fundamentals.
In low and middle-income countries there's very little infrastructure for testing. That is, you don't have large commercial laboratories, like you do here in the U.S. and in Europe. So self-testing is really ideal for that. We understand the cost structure. We understand the price points in those countries. And so that's what gives us confidence that we'll be successful around the world, not just in the U.S.
Okay. Understood. And then, maybe just on the U.S. side with EUAs, certainly, encouraging to hear, the submission by the end of the month. Can you just talk about the path forward? Are you guys going to release press release when you submit it?
And then, obviously, a little bit out of your hands, but anything you're hearing in terms of what the turnaround time could look like in terms of approval and actually being on the market?
Yes, certainly. Yes, we do intend to issue a press release once we submit the EUA, since we've been projecting that in the first quarter of this year. As far as turnaround time, that's out of our hands, of course.
But I think, we're seeing turnaround time somewhere in the order of six to eight weeks from FDA for similarly situated products. So that's only past history. That doesn't guarantee what the future looks like. But for planning purposes, that's the time frame we're dealing with.
No, that's helpful. And then maybe last one. I guess, when you think out you're obviously seeing some pretty -- durability to the market you're talking about here. When you think about the different pieces of the market, can you talk about OTC versus again maybe some employers, travel, et cetera here in the US versus international?
Kind of how are you sizing them, internally in terms of obviously some of that capacity, where you're planning on that going? Just curious, in terms of when you think about this market a year or two years out. Clearly you're still believing it's real, what pieces really makeup a big piece of the pie there?
Well, the reason that we were keen on accelerating our clinical trials for the prescription self-test is that, that is a real sweet spot for us in the marketplace. We shared in our remarks that we -- that the market size for prescription self-test is in the order of about 16 billion per year.
So that gives us a lot of flexibility to address employer, education needs, nursing homes, prisons, travel, leisure. There are some very durable opportunities there. Now obviously, the OTC market is an area that a lot of people are interested in, because that gives absolute power to the consumer to do testing. That's going to be important as well.
But I think that having physicians prescribe the test is not a significant barrier for the markets that we want to penetrate. And that's why we're so focused on the Rx self-test area.
All right. Thanks, Stephen. I look forward to keep an eye on the progress.
Thank you. [Operator Instructions] Our next question or comment comes from the line of Andrew Cooper from Raymond James. Your line is open.
Hi guys. Thanks for the questions. I guess, a lot has already been covered, but maybe just take a step back and just think about the capacity expansion and the fact that, at some point regardless of when we want to talk about it is, at some point COVID testing will likely decline from some of the demand levels we talk about today.
Can you give us just some thoughts on, the opportunity for more tests in the home? I think to some degree the FDA has let the cat out of the bag, by allowing home testing at all, for more infectious diseases where they've been more cautious before. So, do you see that as an opportunity and something that given the capacity expansions you're putting in place? Could be a nice way to absorb those extra manufacturing capabilities further down the road?
Yeah. You're absolutely right Andrew. That the focus on self-test has never been higher. And of course OraSure has unique experience in that, because when we had our HIV in-home test approved as an OTC test back in 2012, we were at that time the only infectious disease self-test on the market. And until-2020 we were still the only OTC infectious disease test on the market.
So, yes, the market has opened up. We refer to that domain as, effortless diagnostics. So it's something that anybody can do with very little skill, or training. It's something that they can do in the privacy of their own home. Anybody can be tested, anywhere, at any time. So it is really incumbent on us to find new opportunities for effortless diagnostics in the marketplace.
One of the nice things about our capacity expansion is that, it's all the same basic product, whether it's our HIV, HCV or Ebola product or the new line of COVID-19 products. These are all on the basic manufacturing platform for all those products together. So that similarity will help us with scale over time as we develop new products. And so I think we are well-positioned, uniquely positioned to capitalize on other diagnostic opportunities going forward.
Okay, great. And maybe just one on the antibody test as well, because this hasn't been asked yet. But I think when you talked about the FDA initially wanting the EUA split and some extra data there; we're getting near the time lines we had talked about. So can you give us a little bit more specificity on where we are in that process? And I know you said as expeditiously as possible, but what we need to see before we can see an EUA for that product as well?
Yeah. So, we haven't described the time frame for that, but it is as soon as possible. And when we made the announcement that we had to submit two separate EUAs back in the end of December, we said a little bit about the types of tests that we needed to run. Most of those studies are already done. So that's moving right along.
And just as a refresher, the reason we had to do so was there was no template for an oral fluid-based antibody test. And so it required the pioneer's challenge for us -- for the FDA to describe the additional studies that needed to be done. So that's going well. Again we're looking to get that through an EUA as soon as possible, but we have not described the time frame beyond that.
Okay, great. And maybe just one last one. We've seen one of your major genomics customers likely coming to the public market via SPAC. I mean, does that change anything in terms of the way you think about the relationship there, or anything in terms of some of the contracting and how you expect the growth from that customer especially given some of the numbers that they put out there into the marketplace at this point? Just any comment there after that development would be great?
Well, I think that development confirms that the focus of genomic testing on medical applications what we call disease risk management is a real sweet spot for them and for us. They remain a very strong strategic customer to us. We are under a long-term supply agreement with them. I think the fact that they are public now will give us better visibility on where they're headed both strategically and quarter-by-quarter performance. And so we're very optimistic about that relationship and remain so.
Great. I’ll talk later. Appreciate it.
Thank you. Our next question or comment comes from the line of Frank Takkinen from Lake Street Capital. Your line is open.
Hey, thanks for taking my questions. Just two from me today. Thinking about gross margin as testing becomes a little bit larger portion of revenue in the back half of this year assuming approvals, how should we think about the gross margin profile of the aggregate company for 2021?
Thanks for the question Frank. So as we've described in the past, we expect that the gross margin percentage for each one of the three COVID-19 testing opportunities is going to be higher than the average of the company or of the business unit from, which the product is being sold. So we would expect that as those volumes increase with the EUA of additional products and with the continuing growth of our existing collections devices, gross margin percentage should improve over the course of the year.
Perfect. And then on the business development front maybe give us a little update on your thought process here. Should we expect to potentially see something in the near and immediate term, or do you feel your plate is plenty full with the COVID opportunities at the moment?
Yes, we have a very robust business development acquisition pipeline, Frank. I think the inbound interest has never been higher. We continue to evaluate that pipeline in terms of the right fit and the right potential. So, we have not and will not make predictions about when the acquisitions will occur for a variety of reasons.
But we have a lot of optionality right now with $257 million in cash on our balance sheet and no debt and looking for companies and technology and products that fit with our overall strategy which, of course, are our multiomics strategy on the molecular side and effortless diagnostics on the diagnostics side.
So, it's a rich environment out there right now for targets. So, as we've been saying for a while we're intent on doing the right deal at the right time at the right valuation. So, we'll continue to look at that pipeline and execute against it. So, we do have capacity to do so and we are actively in the market.
Great. Thanks for taking my questions.
Thank you. Our next is a follow-up from Mr. Vijay Kumar from Evercore ISI. Your line is open.
Hey guys. Just one quick follow-up for me. I know we don't have the annual revenue guide, but I guess, just given how antigen testing is ramping for some of your peers, even if I did assume like a $10 ASP and you guys sell 50 million tests, that's $0.5 billion of revenue. That's already about -- I think Street's at $400 million. You have a base business that's north of $150 million and you have a collection kit. And it's very hard for me to see how revenues for fiscal 2021 could be sub-$700 million. I'm curious if you had any comments on how we should be thinking about fiscal 2021 if not a formal guidance perhaps some broad strokes.
Sure. Thanks for the question Vijay. So, first I'd say that your arithmetic makes sense. The biggest variable for us is the FDA and the timing or actuality of EUA approval, which presents a lot of variability -- either one of those dimensions presents a lot of variability to total revenues. So, that's the main driver of our not giving full year revenue guidance. But as you say it could be a very big year for us if everything lines up correctly.
Understood. Thanks guys.
Thank you. I'm showing no additional questions in the queue. At this time, I'd like to turn the conference back over to Dr. Tang for any closing remarks.
I want to thank everyone for participating in today's call and for your continued interest in OraSure. Have a good afternoon and evening and stay safe and be well. Thank you.
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.