OraSure Technologies Inc (OSUR) 2021 Q1 法說會逐字稿

Good afternoon, everyone, and welcome to the OraSure Technologies first quarter 2021 financial results conference call and simultaneous webcast. As a reminder, today's conference is being recorded. (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 in 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 31st, 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. I'm pleased to report another record quarter for OraSure. Our 85% growth in first quarter of net revenues represents the third quarter in a row of year-over-year double-digit revenue growth. Our sample collection devices for COVID-19 molecular testing continue to make a significant contribution to our revenues. Our genomics, microbiome, and domestic HIV diagnostic businesses showed strong performance as well. We achieved a significant milestone in March when we submitted our COVID-19 rapid antigen tests to the U.S. Food and Drug Administration for Emergency Use Authorization and look forward to bringing both a prescription home test and a professional test for point-of-care use to market. We are confident in the market potential for our COVID-19 products as well as the resilience of our non-COVID businesses.

Total net revenues of $58.6 million for the first quarter were driven by strong revenue performance of $43.2 million from the molecular solutions business unit. We recorded $27.4 million in revenue from our sample collection kits for COVID-19 molecular testing and expect our molecular sample collection kits to continue to meaningful contribute to our business as testing remains a key strategy to combat the pandemic.

Top of mind for investors is the outlook for COVID-19 testing, given the downward trend in testing numbers. Before providing further detail on our activities, I'd like to offer our perspective on the global COVID-19 testing landscape. Here in the U.S., vaccines are readily available and the number of cases in the U.S. has dropped meaningfully since the start of the year. However, as variants continue to spread, testing will continue to play a crucial part in mitigating the spread of the virus and helping to safely reopen workplaces, schools and other places where people gather. A recent McKinsey report notes that rapid, accurate testing will play a key role as the transition back to pre-pandemic routines continues.

The emergence of new, more contagious variants of the coronavirus underscores the importance of testing to detect infection even as vaccination campaigns continue. Scientists are particularly concerned about the rising prevalence of variants, which they say could prolong the pandemic. When you factor in vaccine hesitancy, it becomes apparent that achieving herd immunity, they take longer than hoped for or even be elusive. Experts estimate that 70% to 85% of the population must be vaccinated to stop the spread of COVID-19, yet 1/4 of Americans say they probably or definitely will not get vaccinated. In some states, supply is now higher than demand.

Outside the U.S., however, the vaccine rollout is slower. Bloomberg projects it will take years to achieve significant global herd immunity. While McKinsey knows that herd immunity may look different across the world, with some areas achieving it, others moving in and out of it and some failing to achieve it due to vaccine hesitancy. Market research reports forecast a robust testing market with estimates of total global volumes for molecular and antigen tests in the range of 2 billion to 4 billion tests in 2021. Consequently, we believe the need for convenient, safe and accurate testing will continue alongside vaccination rollouts and our tests and molecular sample collection kits will be critical to this effort. OraSure is dedicated to simplifying COVID-19 testing.

Our test and collection kits are all centered on the convenient, pain-free self-collection of samples, making it easier for people to know if they have COVID-19. The simplicity and ease of use can help increase access to testing, alleviate the burden on the healthcare system, minimize exposure risks and conserve personal protective equipment. Our molecular sample collection kits made by our DNA Genotek subsidiary continue to drive performance showing continued sequential quarterly growth.

Demand has been driven by both high volume repeat orders from existing customers and from new customers engaged in back-to-work and back-to-school testing programs around the world. As a reminder, our OMNIgene ORAL and ORAcollect RNA collection devices have received EUAs from the FDA, allowing for the unsupervised use of these devices at home or in healthcare settings when used as part of an approved or validated at-home test kit.

They are also included in 8 EUAs received by DNA Genotek's customers. ORAcollect RNA saliva collection devices have been used in more than 2 million COVID-19 tests developed by DNA Genotek customer Quadrant Biosciences, in partnership with SUNY Upstate Medical University, up from the 1 million administered tests SUNY announced in February of 2021. This test has been used extensively by State University of New York campuses since the start of the fall 2020 semester.

Turning to our COVID-19 rapid antigen tests. We were delighted to announce in March that we had submitted an EUA application to the FDA for our COVID-19 rapid antigen tests for both prescription home use and professional use at point-of-care settings. The concurrent submission for both products represented in an acceleration of the prescription home test used product and reflects our continued focus on the home testing market. This easy and intuitive swab, swirl and see test detects active COVID-19 infection with no instrumentation, batteries or smartphone needed to read the results.

Users simply swab their lower nostrils, swirl the swab in buffer solution and see the result right on the test stick a short time later. It's that simple. With just a few steps to follow, we believe our tests would be one of the simplest COVID-19 tests on the market. We expect that its simplicity will give users peace of mind that they're performing the test correctly and can be confident in the result.

Our rapid antigen tests are well suited for use by individuals at home as well as healthcare providers, employers, pharmacies and universities, because they do not rely on batteries, electricity, cell service or Wi-Fi, our test could be administered wherever testing is needed, such as underserved communities where vaccinations are low and COVID incident is high. We have begun manufacturing our antigen test as we await Emergency Use Authorization. We also plan to pursue an over-the-counter indication for our rapid antigen test. Given our experience selling our HIV tests over the counter for close to 10 years, we are well suited to capitalize on this opportunity once authorized by the FDA.

Turning to our oral fluid antibody test. We have collected the data requested by the FDA and plan to submit separate EUA applications for the ELISA microplate assay and the OraSure oral antibody collection device. This lab-based antibody test can aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. Our test has the potential to be the first oral fluid antibody test to receive FDA Emergency Use Authorization. To date, all the FDA-authorized antibody tests require a venous blood draw or fingerstick. Antibody test can play a role in community in surveillance efforts and seroprevalence studies.

We continue to sell this pioneering product for research use only, and it's been validated by numerous laboratories. With this quality of the tests, individuals would self-collect an oral fluid sample using the OraSure Oral Antibody Collection Device under the observation of a healthcare professional. The sample would be placed in a buffer vial for storage and transport and later dispense on to the OraSure SARS-CoV-2 ELISA microplate for testing in the laboratory. Each of OraSure's accurate, easy-to-administer testing and collection methods, in conjunction with vaccination efforts, can play a key role in identifying COVID-19 cases, isolating the infected, controlling outbreaks and helping the world get back to normal. We are confident in the sustained market potential for our COVID-19 solutions. As the recent surges around the world have shown, COVID-19 is still having a significant impact worldwide.

We are prepared to address this global opportunity. Our molecular sample collection kits are already authorized in Europe and in Canada. We are actively working on the requirements for international regulatory approvals for our rapid antigen tests and plan to leverage our existing infrastructure of teams and distributors. If we capture just a small percentage of the global COVID-19 testing market, it will have a meaningful impact on the company.

And with that, I'll turn it over to Roberto for report on our financials and an update on our COVID-19 manufacturing capacity expansion. Roberto?

Thank you, Steve. Our first quarter net revenues increased 85% to $58.6 million from the $31.6 million we reported in the first quarter of 2020, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing, higher genomics product sales and increased sales of our over-the-counter OraQuick In-Home HIV Test. This was partially offset by lower sales of our HIV and HCV professional products and risk assessment products.

Net product and services revenues were $56.6 million, an 83% increase from the first quarter of 2020. Total product and service revenues for the company's molecular business unit were $44 million during the first quarter of 2021, an increase of 219% from the first quarter of 2020. This increase included $27.4 million in sales of oral fluid sample collection devices for COVID-19 molecular testing. Domestic sales of the companies OraQuick HIV tests increased 26% compared to the first quarter of the prior year, largely due to higher sales and the over-the-counter OraQuick In-Home HIV Test.

International HIV and HCV revenues declined 42% over the prior year due to several large distributor orders, which occurred in the first quarter of 2020, and variations in timing as compared to 2021 ordering. Overall, underlying international growth in HIV and HCV testing is still strong versus prior year outside of the single quarter timing impact of these distributor orders.

Gross profit percentage was 65% for the 3 months ended March 31, 2021, compared to 51% in the same period of 2020, due to an improved product mix of higher gross profit percentage product sales. Net income for the first quarter of 2021 was $3.8 million or $0.05 per share on a fully diluted basis compared to a net loss of $7.3 million or $0.12 per share on a fully diluted basis for the first quarter of 2020. First quarter 2021 results included the benefit of $806,000 for the change in the estimated fair value of our acquisition-related contingent consideration compared to a charge recorded in the first quarter of 2020 of $1.1 million.

2021 results also reflect the additional product development in sales and marketing costs incurred for our COVID-19 tests as well as increased tax expense associated with the improved results of the company. Cash and investments totaled $240.5 million at March 31, 2021. As we disclosed in our press release, we expect revenues of $55 million to $60 million in the second 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.

I'll now turn to our manufacturing capacity expansion efforts for our COVID-19 products, starting with our rapid antigen test. As of the end of the first quarter, all the equipment needed to achieve the previously communicated planned capacity of 55 million units annually is on site and either installed or in the process of being installed. More specifically, lines capable of manufacturing 44 million units a year are in place with the remainder to be finished by the end of May.

Plans are on track to achieve 70 million units annually of installed capacity in the third quarter and 120 million units by the second quarter of 2022 as previously disclosed. These are annualized numbers of installed capacity and include our existing tests for HIV, HCV and Ebola, and will require some ramp-up time for validation and new employee training. For our oral fluid antibody test, we currently have installed capacity of 10 million units per year, including existing products, as we have previously communicated. We remain on track to expand this capacity to 20 million units a year by the end of 2021.

Capacity expansion for molecular sample collection kits exceeds our original projections. We are expanding installed capacity of our molecular sample collection devices to a rate of approximately 80 million units annually in the second quarter of 2021, ahead of the 75 million annual units previously communicated and further to 105 million units annually by the end of 2021. Of this capacity, we expect that 7 million to 8 million units annually will go to non-COVID-19 applications.

With that I'll turn the call back over to Steve.

Thank you, Roberto. I'd now like to provide some brief updates on our non-COVID-19 businesses, which has shown not only resiliency, but in some cases indication of return to pre-pandemic levels. In fact, our molecular non-COVID-19 business rebounded beyond first quarter 2020s pre-COVID levels, signaling the COVID-19 headwinds in the molecular market may be subsiding. Non-COVID molecular product revenue in first quarter grew 32% over the prior year. Our total genomics business was up 32% for the quarter with signals of recovery driven by momentum in the disease risk management, ancestry and companion animal markets.

Our academic markets for genomics is also showing signs of resilience with a 9% growth over prior year quarter. Our microbiome collection kits business rebounded in the first quarter with a 32% growth over the same quarter a year ago, driven by demand from our commercial customers. We expect our commercial microbiome business will continue to recover as investment continues in the microbiome industry, driving growth potential for both Diversigen services and DNA Genotek kits.

Turning to our diagnostics business unit, overall domestic diagnostics revenue was on par with first quarter 2020, despite COVID-19 headwinds. Sales of our over-the-counter HIV In-Home Tests grew by triple digits over the prior year as public health HIV testing programs in the U.S. continue to use our over-the-counter product.

For example, the Centers for Disease Control and Prevention is distributing our OraQuick In-Home HIV Tests via partnership with Insignia, Building Healthy Online Communities and Emory University. CDC's Let's Stop HIV Together campaign is leading the marketing efforts and sending consumers to a unique website link to order test. This large scale and targeted distribution of self-test kits to populations disproportionately impacted by HIV/AIDS will assist CDC in future efforts related to in-home testing strategies and contribute to the Ending the HIV Epidemic initiative.

International diagnostic revenue was down from a year prior, largely due to unusually large orders from initial programs stocking in first quarter 2020 and variable timing associated with restocking. The underlying growth in Q1 outside of these stocking orders is still strong and we expect international diagnostics revenue in the first half of 2021 to show strong growth versus 2020. Finally, before we move on to the question-and-answer session, I'd like to share with you a few summarizing thoughts.

Our business is strong and we expect our momentum to continue in a balanced manner. As you've seen, our non-COVID revenue is beginning to return to pre-pandemic levels and our COVID-19-related revenue remains robust. We believe the collective contributions from our rapid antigen tests and oral fluid antibody test will be substantial, subject to receipt of EUAs for these products. And we're confident we'll continue to make significant commercial strides with our molecular sample collection kits.

Lastly, we will leverage our strong balance sheet with more than $3 per share in cash to maximize the COVID-19 tailwinds, fund R&D on our non-COVID businesses and fuel our business development activities. For these reasons, we think we are in an excellent position to capitalize on multiple fronts and drive further growth in the coming quarters.

With that, operator, please open the call up for questions.

(Operator Instructions) Our first question will come from the line of Frank Takkinen from Lake Street Capital.

A couple for me today. Starting with the guidance. I was hoping you could help us understand some of the components into the $55 million to $60 million guide, looking at the COVID molecular revenues and the growth trajectory they've been on, I was hoping that you could maybe just tease out directionally that specific line item to give us a better feel for the pieces of guidance in Q2 '21.

Sure, Frank. Thanks for the question. So for the second quarter of guidance of $55 million to $60 million, we did not include into that any contribution from post-EUA sales of either of our antigen or antibody tests because of the -- because the authorization timing is uncertain. So that $55 million to $60 million will reflect revenues similar to or sources similar to what we saw in the first quarter of ‘21. We haven't broken it out more granularly by line item or sales contribution, so I can't give you any additional guidance on the COVID-19 contribution. Any other questions on that?

No, I'll just ask my follow-up, given the international market is becoming more and more important, it seems like, can you just refresh us on the approval process and potential timing to getting your antigen test in the international market?

Sure, Frank. We are exploring right now the regulatory requirements for our rapid antigen tests outside the U.S., including which of the most attractive markets and the timing of those regulatory processes. So that will come shortly after we receive hopefully favorable word from the FDA on our rapid antigen test and our current submissions. So it will happen as quickly as possible, but of course our first focus is to get into the U.S. market, but I think you are rightfully focused on the outside U.S. market because that's where the pandemic is still raging in places like India and elsewhere.

So we are very mindful of that. Of course, we have widespread experiences and helping to test for pandemics, including HIV, and I think our experience will serve us well in those markets.

And our next question will come from Vijay Kumar from Evercore ISI.

Stephen, maybe on the antigen side, I guess you guys submitted on March 30th, so it looks like 6 weeks approval for that, some point in mid-May potential approval. Given that average price at $5, what is -- I guess can you talk about the opportunity for you guys? Can you sell -- be competitive at those price points? And then I had a couple of follow-ups. Yes, let's start with how you see the opportunity in the U.S.

Sure, Vijay. I think as we know, the $5 price for that particular product was I think a price to the government and it was for a professional product. Since then pricing has been updated, I think, for the developments, particularly in the OTC market. So we're very conscious of that.

I think we're going to have an extremely competitive product regardless of the domain. So that's professional prescription self-tests and even OTC at some point. And I think that we're looking at the pricing right now on the OTC side in particular, and I think we can be competitive particularly since our product I think is well differentiated for its ease of use and simplicity, which I think will become increasingly important as self-tests get used more often by a wide range of people. So I think we remain very confident even though the testing of the -- excuse me, the pricing environment has changed.

Got you. So just to be clear, Stephen, the -- I guess when you look at the retail pricing, CVS, Walmart, I think Abbott selling a 2-pack test for roughly around $24, $25, you'll be able to match those price levels.

I think we will be very competitive in the marketplace considering what the current pricing is and considering the value proposition overall for our product. Yes, absolutely.

Okay. And then two quick follow-ups, one on 2Q. What trends are you seeing in collection kits? Some of the molecular testing companies, we've seen some pretty big cuts to numbers. And on the antigen side, how I guess -- is this still a meaningful opportunity, because the question I'm getting is, is OraSure too late? And how should we think about antigen contribution in the back half?

Sure. Let me just give you some perspective on the overall market. We absolutely have a tremendous opportunity, so we're not too late. The market research firm, Kalorama Information, says that the total global antigen testing market for COVID-19 is about 19 billion a year, 5 billion of that is in the U.S. We have a product I think that is going to be one of the simplest use on the market that I think will be useful to consumers and to healthcare professionals have confidence in the test results. So I do think that opportunity is large.

Vijay, you know us well enough to know that we're a relatively small company compared to the makers of tests that currently have OTC approval, at least two of them. So we can do very well for us as a company and for our shareholders, even with capturing just a small portion of that antigen test market.

And I think we're gearing up our manufacturing capability and looking forward to our product launches accordingly. On the molecular side, Kalorama says that the global molecular testing market is about 17 billion a year. I think the slowdown in lab-based testing has been well documented by you and others. We believe there's going to be an opportunity that's still very strong for us in the sample collection area. We noted in our prepared remarks that one of our customers, Quadrant Biosciences, has now surpassed 2 million tests within the State University of New York system. I think there'll be a need for ongoing tests.

Those customers that are well entrenched in testing modalities like SUNY is for their students and their staff will continue to buy, and we are monitoring the situation very carefully. We've tried to be on the conservative side of our projections for testing overall, and we'll continue to do so. So that's why we remain very confident, very optimistic that we can maximize our opportunities for COVID-19 for the rapid antigen tests, for the molecular collection kits and somewhere down the line even the antibody tests. So I think the prospects for us remain very strong.

(Operator Instructions) Our next question will come from the line of Andrew Cooper from Raymond James.

Maybe just start on the collection side, I guess first, has there been any sort of change in the competitive landscape when you think about pricing or sort of options out there now that we're a little bit past the point where swabs and tubes were such a constraint like they were earlier in the pandemic if any comment there would be helpful. And then when we think about big customers like Quadrant or some of the others, can you give us a flavor for how much of the sales in 1Q or maybe contracted what the duration might look like or any color there to think about sort of contract with durability as things progress through 2021 and beyond?

Sure, Andrew. We're not saying switching from our product to other products, first of all. So I think we've got a very reliable sample collection kit, one of which is a saliva collection kit, the other is a swab -- sponge swab kind of configuration, not swab in the nasal swab sense. So I think that the opportunity is very durable. And so we're not seeing a substitution effect there.

The buying behavior of customers I think is -- remained strong. I think that they are looking at variability in their needs and demand as well. I think that's a macro issue with all lab-based testing. But the story does hold together for us very well, I think, because of our close customer relationships and our expanding relationships elsewhere, including outside the U.S.

Okay. That's helpful. And then maybe just on the antigen side, when we think about OTC, I think the FDA has really sort of lowered the bar for folks as things have progressed and we think about the serial testing and what they're requiring for asymptomatic positives and things of that nature. So what do you need to do to get that particular claim, the OTC claim to the FDA? What's left on the docket for you to get that package together and make that submission?

Well, Andrew, I think that's an important question because much has changed in the OTC COVID-19 rapid antigen testing world since we spoke at our last earnings call in March. Two new products have come on the marketplace. And I think our observation that FDA's requirements have shifted over time is true. I think that we're fortunate to have had a close relationship with FDA dating back to 2012 when we launched our OraQuick In-Home HIV Test. So we're a known entity to them, particularly for self-tests for infectious disease. That's going to help us quite a bit. I think we have a clearer sense today than ever before what we need to do to get a submission for OTC.

And so I think we are determined to do so. We're not projecting when, but I think that we're very competent that we have the pathway well in hand and well understood. So there are a number of things you have to do above and beyond the submissions for the prescription self-tests and for the professional tests, which are already underway. But we have been encouraged by our close working relationship with FDA and hope to get that OTC product into submission and on the market as soon as possible.

And just as a quick follow-up to that, should we expect that it is an authorization for a standalone use or for serial? What's the kind of current thinking on the strategy from that perspective?

Yes. So one of the things that FDA has made clearer in the past couple of months is a difference between a diagnostic test and a screening test. So diagnostic test is one for those who are infectious and the screening test is a test for asymptomatic and others. Screening tests lend themselves to serial testing, which is what you're calling attention to, packages that have more than one test in them. We are very well aware of that. I think that can be a good use case for us and we're working towards getting that use case firmed up and getting it through FDA.

And our next question comes from the line of Brandon Couillard from Jefferies.

This is [Matt] on for Brandon. To start, you guys indicated you've started to manufacture your rapid antigen test while you await EUA clearance and clearly a lot is dependent on timing of approval, but any color you can give on how many you expect to have manufactured at launch? And then, I guess what portion of that is already spoken for or do you expect to be spoken for at launch across the number of different potential customers and use cases from back to work to a number of healthcare settings as well?

Yes. Sure, [Matt]. We have not disclosed how much manufacturing we've done at risk but we are doing so as we speak. As you noted, the approach is to have product ready to go once we have EUA from the FDA. So that is absolutely what we're aiming at. We have different requirements depending on the use of the product, so the professional test, the prescription self-test and somewhere down the road, the OTC will have different labeling and box requirements. So we're taking that into account also.

But when we get up to full speed in terms of manufacturing and once we have approval, we're very confident that we're going to be selling as much product as we can make over time. So I think we have designs on a steady stream of business over the coming months through 2021 and into 2022 and that's what we're focused on.

Great. That's helpful. And then quick one for Robert, gross margin, 65% this quarter. The guidance kind of calls for similar revenue base. Is there anything to call it on mix or can we kind of expect gross margins to continue to trend to kind of that mid-60s range?

So for the first quarter, gross margin was driven very much by mix. So if you look at the tables at the end of our press release, you'll see that obviously the COVID-19 collection devices kits were up substantially over the prior year, where the sales were mostly nominal. And we've talked about how all of the COVID-19 testing opportunity products are at the higher end of the margin range.

On the other side of things, our international sales of our HIV kits were down pretty substantially just due to some timing of shipments. And so those two things together combined to drive the 65% gross margin percentage. So depending on how exactly those two things shake out proportionally with regard to each other in the second quarter, you could see some change to that gross margin percentage from the first of the second quarter.

(Operator Instructions) And I'm not showing any further questions in the queue. Yes, we do have one question from the line of Patrick Donnelly from Citi.

I just wanted to ask on the demand side, obviously you talked a little bit about U.S. versus OUS. I mean it seems certainly that OUS is a little more compelling long term. But in the U.S. side, I mean how much have you guys talked before approval to the employer side, travel? I'm just trying to think of what the demand could look like as you get to the market here and if there is anything in place in terms of contracts if you could just talk through the U.S. piece a bit more, it'd be helpful.

Certainly, Patrick. Inbound interest has been strong and remain strong, particularly in buyer groups or universities, employers, physician offices, public health and government buying entities. Obviously, we cannot promote and contract until we have an EUA. But we've advanced those discussions progressively as we've been able to share more about the product design and the use cases.

And so we are very confident that those domestic use cases remain intact. I think as testing moves to more self-testing options in the marketplace, the attributes of our product and their competitiveness versus existing products will be easy to see. So the demand remains strong, interest remains strong, and we're hoping to confirm all those interests into sales and contracts once we receive our EUAs.

Yes. And Stephen, maybe on that point, you kind of touched on the competitive side. Obviously, the market is getting more competitive as we go here. When you think about the differentiation pieces out there, I mean how much -- when you think about first mover versus the data itself versus the ease of use, how do you rank those things in terms of what you've heard from folks you've chatted with as being the most important when several market -- several products are on the market? What do you think moves the needle for the potential customer base?

Well, I think based on our experience with HIV in-home testing and we've been on the market close to 10 years with that product, the ease of use of the product gives people confidence that their results are accurate and that's the value proposition. So I can't really speak to how that shapes up with other products on the marketplace, other than to say, if those are the differentiators then our cases very strong.

So -- and we recognize we're not the first to market, but there are some attributes of our product in terms of ease of use, in terms of the integrated swab into the product design, which I think are going to be extremely helpful to us. And so that's why our outlook remains very strong on the product in the U.S.

And I'm not showing any further questions in the queue. I'd like to turn the call back over to the speakers for any closing remarks.

We'd like 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 very much.

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