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 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 statement, 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. I am pleased to report another record quarter for OraSure. Our 85% growth in first quarter 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, and 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 test 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 meaningfully 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…

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 company’s OraQuick HIV tests increased 26% compared to the first quarter of the prior year largely due to higher sales of 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, the 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 three 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…

Thank you, Roberto. I’d now like to provide some brief updates on our non-COVID-19 businesses, which have shown not only resiliency, but in some cases, indications of a return to pre-pandemic levels. In fact, our molecular non-COVID-19 business rebounded beyond first quarter 2020’s pre-COVID levels, signaling that COVID-19 headwinds in the molecular market may be subsiding. Non-COVID molecular product revenue in the 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 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 test 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 a 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 tests. 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…

[Operator Instructions] Our first question will come from line of Frank Takkinen from Lake Street Capital. You may begin.

Hey, thanks for taking my questions. A couple from 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 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, 2021?

Sure. Frank. Thanks for the question. So for the second quarter 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 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 2021. 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. And 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 are 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. So, 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.

Perfect. Thanks for the color.

And our next question will come from the line of Vijay Kumar from Evercore ISI. You may begin.

Hey guys, thanks for taking my question. Stephen maybe on the antigen side, I guess you guys submitted on March 30. So it looks like six weeks approval. We’ll put that in at some point in mid May potential approval given that average price $5. What is that I guess that, can you talk about the opportunity for you guys? Can you sell be competitive that 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 the 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 a 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 for us, we remained very confident even though the testing of the – excuse me, the pricing environment has changed.

Gotcha. So just to be clear Steven the – I guess when you look at the retail pricing [indiscernible] think Abbott selling the two-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 and some of the molecular testing companies we’ve seen some pretty good cuts to numbers and on the antigen side how, I guess is this still a meaningful opportunity? Because the question I’m getting at is or short delay 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 form 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, as well enough to know that we’re a relatively small company compared to the makers of tests that are 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 is 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 two 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 test. So, I think the prospects for us or remain very strong.

All right. Thanks guys.

Thanks, Vijay.

[Operator Instructions] Our next question will come from the line of Andrew Cooper from Raymond James. You may begin.

Hey guys, thanks for the questions. Maybe 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 twos were such a constraint like they were earlier in the pandemic, just 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 contracts with durability as things progressed through 2021 and beyond?

Sure. Andrew we’re not seeing 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 and 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 you think about OTC, I think the FDA has really sort of lowered the bar for folks there’s, as things are progressing. We think about the serial testing and what they’re requiring very symptomatic positives and things of that nature. So, what do you need to do to get that particular claim that 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 in our last earnings call in March, two new products that come on the marketplace, and I think your observation that FDA’s requirements have shifted overtime is true. I think that we’re fortunate to 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 confident 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 a 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 months is a difference between a diagnostic test and a screening test. So diagnostic test is one for those who are infectious and a screening test is a test for asymptomatic and others. And 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.

Great. I’ll stop there. Thanks.

Thank you, Andrew.

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

Hey guys, this is Matt on for Brandon. Thanks for taking the questions. To start, you guys indicated you’ve started to manufacture your rapid antigen test while you wait you 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? Thanks.

Yes, sure Matt. We have not disclosed how much manufacturing we’ve done at risk, but we are doing so as we speak. And 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 center calls for similar revenue basis or anything to call it on mix? Or can we kind of expect gross margins to continue to trend and 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. We’re – 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.

Super thanks. I’ll stop there.

[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. You may begin.

Hey guys, thanks for taking my question and squeezing me in. I just wanted to ask on the demand side, obviously you talked a little bit about U.S. versus OUS., and 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 about 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, you may – 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 remains strong. Particularly in buyer groups, our universities, employers, physician offices, public health and government buying entities. Obviously we cannot promote and contract until we have at 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 it remains strong, interest remains strong, and we’re hoping to confirm all those interests into sales and contracts once we receive our UAS.

Yes. And Steven, 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 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 markets – 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 are our cases very strong. So, 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.

Understood. Thank you, guys.

Thanks, Patrick.

And I’m not showing any further questions in the queue. I like to turn the call back over to 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.