Good afternoon, everyone, and welcome to the OraSure Technologies 2020 Third Quarter 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 speakers' remarks, there will be a question-and-answer period. I would 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 a question-and-answer session. Before I turn the call over to Dr. Tang, you should note 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 strategy. 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, 2019, 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 know last night was a late night for many, so I appreciate your attention and interest this afternoon. I hope you and your families are faring well during these challenging times. As you will hear today, OraSure had a strong quarter. Our molecular sample collection devices are widely used for lab-based COVID-19 molecular tests. We've submitted our lab-based oral fluid SARS-CoV-2 antibody test to the FDA for emergency use authorization or EUA, and we expect a rapid coronavirus antigen test to be ready for EUA submission in Q1 2021. Overall, our ability to address the COVID-19 pandemic through sample collection has contributed positively to our business in the third quarter. We generated $48 million in revenue this quarter, a 33% increase over the prior year. This performance was driven by our Molecular Solutions business unit. Our products continue to be in demand as the need for COVID-19 testing continues to rise. The Molecular Solutions business unit generated $18.4 million in COVID-19 related sales in Q3, which is more than double the COVID-19 revenue achieved in the first half of the year. Globally, we're seeing what appears to be the third wave of the pandemic, as the number of COVID-19 cases surges here in the U.S. and around the world. COVID-19 forecasts are not completely in alignment, but most predict that the current impact will be felt for another year or two years with COVID-19 existing at some level in perpetuity as the disease becomes endemic. While there is hope that a vaccine will be approved by year-end or early 2021, we expect it will take quite some time for a vaccine to be broadly available in the U.S. and internationally. And until then and beyond, testing will continue to play a critical role in managing the pandemic. We expect OraSure to continue to play an important and growing role in addressing the massive and persistent need for COVID-19 testing and sample collection. During our Q2 earnings call, I cited an estimate from the Rockefeller Foundation that called for 1.5 billion COVID-19 tests per year to get the pandemic under control. Since then, the foundation has increased its estimate to approximately 2.3 billion tests per year in the U.S. alone. With this in mind, we expect there will continue to be strong demand for COVID-19 testing for the foreseeable future, and we are prepared to help meet that need with our innovative solutions for testing and sample collection. All of OraSure's COVID-19 products are centered on the easy subcollection of samples by individuals, an area in which we have long experience. Our products are designed to make it easier to obtain results, either through oral fluid sample collection for PCR and antibody testing or through a full diagnostic test that consumers can conduct on their own. I'd like to address our current COVID-19 innovations, beginning with sample collection for molecular or PCR testing, which is the gold standard when it comes to detecting active COVID-19 infection. Our experience in innovating devices to facilitate at-home self-collection of samples has led to significant interest in our collection devices for molecular COVID-19 testing. Devices made by our DNA Genotek subsidiary support both PCR and sequencing-based COVID-19 tests. And these collection kits are now being used for collection at home by consumers or by laboratory staff and healthcare providers. Notably, two of our sample collection devices, ORAcollect RNA and OMNIgene Oral, received EUAs from the FDA in October. Both EUAs allow for the collection, stabilization, and transport of saliva specimens suspected of containing SARS-CoV-2 RNA. The authorization also allows the products to be used as a component of an authorized or cleared collection kit for unsupervised home use. This means the devices can be part of a kit that is authorized under its own EUA for the use of an individual to collect saliva specimens at home. It's important to note that these devices are not COVID tests. They are components of tests that would be run in a lab. DNA Genotek's customers, which are typically laboratories offering COVID-19 test pipeline, would use devices as a sample saliva collection method for their lab-based COVID-19 tests. OMNIgene Oral and ORAcollect RNA are two of three molecular test collection kits that have been included in six EUAs DNA Genotek customers obtained from the FDA. But the EUAs are only one part of the molecular success story. About half of the third quarter sales of molecular sample collection devices for COVID applications were to customers not currently holding EUAs, with the balance of customers operating their COVID tests as Laboratory Developed Tests or LDTs. The use of DNA Genotek collection kits continues to grow in back-to-work settings, back-to-school programs, and laboratory testing. For example, 30,000 students were tested at the University of Kansas before returning to campus using kits from Clinical Reference Laboratory. And 64 state University of New York campuses are testing students and employees with tests developed by Quadrant Biosciences. Our Oragene Dx saliva collection device is available at Albertsons Companies pharmacies throughout the U.S. as part of Phosphorus Diagnostics' COVID-19 testing program. And back-to-work programs are integrating COVID-19 testing, monitoring assessment, and access to telemedicine visits for companies through Azova Inc. Additionally, Costco was selling COVID-19 saliva collection kits in conjunction with P23 Labs, which received an FDA EUA for the laboratory test workflows with their PCR test. The workflow includes OMNIgene Oral as a saliva collection device. Easy self-collection samples are essential to ensuring the safety of workers and students and their families by helping to curtail the spread of the virus as people resume normal aspects of life. We expect the sales of molecular collection kits for COVID-19 testing to continue to grow within the U.S. with existing and new customers, but also outside the U.S. as other nations complete their validation work around saliva as a sample type. Moving on to antibody testing, we have submitted an EUA application to the FDA for our oral fluid SARS-CoV-2 antibody ELISA and are in the review process. To date, there are no oral fluid antibody tests for COVID-19 authorized for sale in the U.S. Pending receipt of an EUA from the FDA, we have the potential to be the first. This saliva-based oral fluid test is intended for the qualitative detection of total antibodies to SARS-CoV-2. We have a number of interested customers and are prepared to commercialize our antibody test in the fourth quarter of this year, subject to receipt of the EUA. Oral sample collection is quick, painless, noninvasive and requires less human contact in comparison to blood draw, both minimizing the need for personal protective equipment or PPE and reducing exposure to potentially infected patients. With OraSure's tests, individuals would use a collection pad to self-collect an oral fluid sample under the direction of a healthcare professional. The sample will then be placed in the OraSure oral antibody collection device buffer for storage and transport. The sample would later be dispensed onto our proprietary ELISA microplate for analysis in a commercial laboratory to determine the presence of antibodies in the oral fluid sample. Potential locations for sample collection include physician's offices, labs, testing facilities, and drive-through testing sites. We are evaluating whether the EUA subsequently could be amended to permit an unsupervised in-home sample collection option with the sample sent to a central laboratory for testing. At an epidemiological level, it is extremely important for public health officials to have an accurate understanding of who has been infected. Antibody tests are well suited for community surveillance and seroprevalence studies as they can help identify people in a population or a community that have mounted antibodies against COVID-19. According to the Centers for Disease Control and Prevention (CDC), this information could be used to estimate the number of people who have been previously infected with SARS-CoV-2 and were not included in official case counts. This is critical to maintaining an accurate count of infection rates and in forming decisions that can advance public health. Antibody tests could also potentially complement vaccine development and implementation. Turning to our antigen test, OraSure continues to make tangible progress in the development of our OraQuick Coronavirus Rapid Antigen Self-Test. Subject to receipt of an EUA, this product would test for active COVID-19 infection using nasal samples self-collected from the lower nostril. Results would be available at the point of collection with no instrumentation needed to interpret results. To date, there are no self-tests authorized in the U.S. that enable individuals to test themselves and read the results at the point of collection with no instrumentation needed. We are highly confident that we can bring to market an accurate test that meets FDA standards for a rapid self-test. And as we disclosed previously, we intend to sequentially introduce our antigen test for three different uses, subject to regulatory authorization. First, a professional test for use at drive-thru sites, physician offices, public health testing sites, and employer and university health centers. In this instance, a physician would prescribe the test and the patient would conduct a self-swab in the presence of a healthcare provider who would then interpret the results. Second, a prescription self-test for use by individual consumers, which could be offered by employers or universities on or off-site or by physicians or public health authorities via remote testing or telemedicine. In this instance, a physician will prescribe the test, and the consumer would conduct the self-swab at home or at any location, where they would then interpret their own results. Thirdly, an over-the-counter (OTC) self-test for use by consumers who would purchase online or at retail without a prescription would conduct the test and receive the results themselves anytime, anywhere. We expect to file for the professional test EUA in Q1 2021, and the prescription self-test and OTC self-test EUAs to follow as soon as possible thereafter. This is a complex process that cannot be rushed. Between now and the filing of the EUA application, we will finalize the device design and complete the EUA studies necessary to determine the achievement of the high-performance standards that the FDA demands of a self-test. We are committed to delivering a rapid antigen self-test that meets FDA requirements for self-tests and the needs of the pandemic as well as our own rigorous standards for quality and performance. We have made a significant amount of progress and completed important benchmarks. Limits of detection studies were conducted with live coronavirus at a certified third-party laboratory to evaluate the analytical sensitivity in comparison to an EUA-authorized instrument-free rapid antigen test. The results from the comparison provided further confidence that the proprietary chemistries incorporated in OraSure's lateral flow test strip will deliver the sensitivity needed. In addition, the company currently has prototypes on the OraQuick platform under evaluation at clinical testing locations, continually providing data on the performance of the design against FDA requirements. Based on what we know at this time, we believe there will be significant demand for our antigen self-test in 2021, as it puts control of the process in the hands of the user. In the U.S. alone, the Rockefeller Foundation estimates demand at approximately 2.3 billion tests annually. The Rockefeller Foundation and others have identified fast and frequent testing as a key to getting COVID-19 under control. This is exactly what our antigen tests will deliver. The timing of the EUA is subject to FDA review. Once EUA is obtained, we are prepared to launch the test without delay. Moving on to manufacturing. Early on in this pandemic, we understood that increasing our manufacturing capacity would be key. To that end, we are confirming that our plans to increase manufacturing capacity to meet demand for COVID-19 sample collection kits and tests continue on track as outlined last quarter. With that, I'll hand it over to Roberto for a report on the quarter's financials. Roberto?

Thanks, Steve. As Steve mentioned earlier, our third quarter net revenues increased 33% to $48 million from the $36 million reported in the third quarter of 2019, primarily as a result of strong sales of molecular sample collection kits for COVID-19 testing, increased international sales of the company's HIV self-test, and higher laboratory services revenues, partially offset by lower sales across all of our other product lines, primarily due to the impact of the COVID-19 pandemic. Net product and service revenues were $46.7 million, a 32% increase from the third quarter of 2019. Total product and services revenues for the company's molecular business unit were $31.2 million during the third quarter of 2020, an increase of 79% from the third quarter of 2019. This increase included $18.4 million in sales of oral fluid sample collection devices for COVID-19 molecular testing, which was partially offset by a decrease in genomic sales. International sales of the company's OraQuick HIV Self-Test increased 17% compared to the third quarter of 2019, largely due to higher sales in Africa. Gross profit percentages were 63% and 60% for the three months ended September 30th, 2020 and 2019 respectively. Gross profit percentage in the third quarter of 2020 benefited from an improved product mix associated with higher gross profit percentage product sales. Net income for the third quarter of 2020 was $1 million or $0.01 per share on a fully diluted basis compared to net income of $13.1 million or $0.21 per share on a fully diluted basis for the third quarter of 2019. Third quarter 2019 results included two gains associated with the sale of a business and a change in the estimated fair value of our acquisition-related contingent consideration together totaling $12.5 million, which accounted for approximately $0.16 per share in 2019. Cash and investments totaled $263.7 million at September 30th, 2020. As we disclosed in our press release, we expect revenues of $55 million to $60 million in the fourth quarter of 2020. As we discussed on our second quarter earnings call, we expect that, as we've just seen with the third quarter non-COVID revenues, will be flat or improved for each business unit in the fourth quarter compared with the second quarter and that COVID-19 product sales will add to this performance. For the full year, we continue to expect that excluding cryosurgical revenues from 2019, non-COVID-19 revenues in both the infectious disease and molecular collection lines of business will be down in 2020 compared to the year-ago period, with molecular collection bearing the greater impact. However, as our revenue guidance for the fourth quarter indicates, we anticipate that the revenue opportunities for our COVID-19 sample collection products and tests will more than offset the year-on-year decrease in our non-COVID-19 lines of business, such that our total revenues will be higher in 2020 than in 2019. With that I'll turn the call back over to Steve.

Thank you, Roberto. Turning to our legacy businesses, HIV testing remains an important area of global focus for OraSure. Access to testing during the pandemic has been challenging as in-person testing facilities for HIV in the United States have been, in many cases, shut down. Self-testing, which enables social distancing and helps protect healthcare workers and test users alike, is a key strategy in the efforts to help people know their HIV status, especially under the current global pandemic conditions. Overall, our net HIV test revenues increased 6% over Q3 2019. This was driven by strong international sales of our OraQuick HIV Self-Test that increased 17% compared to the third quarter of 2019. To put this in perspective, a UNAIDS report noted significant decreases in HIV testing services between January and July in nearly all countries with available data. CDC and other government agencies have encouraged health departments at all levels to consider HIV self-testing as an additional testing strategy to reach persons most affected, which speaks to the usability and convenience of our at-home test, which allows individuals to test themselves and receive the results at home. To date, OraSure offers the only over-the-counter self-test for HIV in the United States and the only World Health Organization or WHO prequalified rapid oral fluid HIV self-test globally. I'd also like to briefly touch on our collection business outside of COVID-19. Although not yet back to pre-COVID levels, we saw increases in our genomics and microbiome kit sales quarter-over-quarter. Third quarter kit sales for genomics and microbiome were up 32% and 114% versus the prior quarter respectively, driven by strength in the commercial market. Academic sales also increased quarter-over-quarter, but to a lesser degree. Our laboratory services revenue showed a slight increase over the previous quarter. We continue to innovate in the microbiome arena, adding new products and services. Our DNA Genotek subsidiary has launched a skin microbiome collection kit. OMNIgene SKIN offers a standard method for collecting skin microbiome samples from sebaceous, dry, and wet skin sites, which will aid researchers in obtaining reproducible high-quality samples. And a great example of how our microbiome services and products team complement each other is a start-up company, Pure Culture Beauty, which has partnered with DNA Genotek and Diversigen to use data and science to deliver a comprehensive customized skincare regimen to its customers. DNA Genotek will supply the OMNIgene SKIN microbiome collection kits and Diversigen will provide full microbiome service, analytical services, offering a complete understanding of the user's skin microbiome. We continue to believe in the promise of our microbiome products and services and look forward to continued growth. In closing, our business momentum is strong, and we expect that trend to continue as evidenced by our guidance. We see COVID-19 testing as a robust part of our business for now and in the foreseeable future. With molecular collection devices already driving significant revenue and our antibody and antigen tests on the road to commercialization, OraSure is poised for continued and sustained growth. Our work with COVID-19 will help accelerate our growth significantly. We understand the opportunity for our tests and sample collection kits is substantial and their role in the fight against COVID-19 is vital. We want to reiterate our confidence in OraSure's ability to bring our antibody and antigen tests to market. We believe they will be worthy of joining the list of our other highly regarded OraSure products. With that, I will open it up to questions.

Thank you. Our first question comes from the line of Vijay Kumar with Evercore ISI. Your line is now open.

Hey guys, thanks for taking my question. Maybe for the first one, Steve, I want to touch on the collection kit opportunity here, $18 million of revenues in the Q. The Q4 guidance implies a modest step up. And I think when you look at the capacity expansion, the goals that you guys had ramping up kit expansion from $35 million to $80 million. So I'm just curious where are we on the expansion? What is the current capacity? Are you selling every single kit that you're making? What should the normalized revenues be for this part of the business once the capacity ramps up?

Thank you, Vijay. I'll start by first saying, we are very pleased with the performance of our Molecular Solutions business unit and in particular the COVID-19 products that they're selling into molecular PCR tests, two products were seeing EUAs as we noted in my prepared remarks. While we're not breaking out revenue specifically, you're right that there is a step-up that's for molecular collection kits for COVID-19 that's embedded in our guidance of $55 million to $60 million for the fourth quarter. By the way, that $55 million to $60 million would be a record fourth quarter for us as a company. We are moving ahead with our expansion plans. We are almost to the point of selling everything we can make, which I think makes up. So I think that as we look into 2021, the expansion that we announced in August will serve us well in terms of providing additional capacity to meet enormous demand in the marketplace. So this area of our business, which I think has come to fruition nicely in the second and third quarter will continue to grow.

Understood. And then I guess one for the follow-up, maybe on the antigen testing side. I understand that there'll be a push-out here from Q4 to Q1. Maybe can you give us some color on what drove the push-out? I guess, the question on investors' minds is what is causing the delay? Are there any technical challenges here? And as you think about that, I guess the language in the press release said that version two, the at-home or self-swabbing version would follow soon after. Is that a first-half event? Or I'm curious on how we should be thinking on the self-swab at-home version of the test?

We’ve planned to seek Emergency Use Authorization for our professional test version in the first quarter. As mentioned in our second-quarter call in August, we will pursue sequential EUAs for the professional test, the prescription self-test, and then the over-the-counter self-test. We will be conducting clinical trials simultaneously to expedite the approval process. While we can’t provide exact dates for when the prescription and over-the-counter self-tests will be available, we anticipate they will come shortly after the professional version is approved. It’s essential to recognize our achievements so far. We are impressed with the technical validation of our OraQuick technology, particularly the test strip's performance in limited detection studies compared to existing rapid antigen tests. This is a significant milestone. The clinical trials leading up to the EUA submission process in the first quarter are expected to confirm our product's success. Our goal is to create a one-step rapid antigen test designed for professional, prescription self-test, and over-the-counter self-test usage, which is not something currently available on the market. We are being thorough, drawing from our experience with the OraQuick HIV in-home test and the development of the Ebola Rapid Antigen test. While unforeseen challenges can arise during product development, we are confident in achieving the EUA in the first quarter, with the prescription and over-the-counter tests to follow soon after.

Sorry, what is the LoD on your antigen testing? And how does it compare to competition?

We haven't disclosed the numbers, Vijay, but they are competitive with existing products. That information is publicly available.

Our next question comes from the line of Frank Takkinen with Lake Street Capital. Your line is now open.

Hi guys, thanks for taking my questions. Just a couple for you here today. I heard you guys talk in your prepared remarks a little bit about the October EUAs for the two DNA Genotek products. I was hoping you could just go a little bit deeper on that and how that could potentially debottleneck the process to continue to drive the momentum behind this business into the fourth quarter as well as into 2021?

Yes. So Frank, thanks for the question. So, I think these are important breakthroughs for the two products that received EUAs. And so that's our ORAcollect RNA and our OMNIgene Oral products. And it's important because essentially there's a pathway now for self-collection that wasn't available on the market before these products were approved. Provided that they are used in a product that has also received an EUA for an individual to collect their own saliva specimen. So the use of the product if you will very clearly mimics what we've done for genomic testing used by companies like 23andMe and others. And so from a technical perspective it was very much in line with our expertise. And so it really does allow a pathway for self-collection for saliva. And I think it's important to recognize how far we've come in molecular testing from nasopharyngeal and oropharyngeal swabs to really the breakthrough which is using saliva, which allows people to take their own sample and not subject themselves to the discomfort or pain associated with those deep swabs. So that's the breakthrough. And I think that evidence of that we provided through the work of our customers. 30,000 students at the University of Kansas tested 64 campuses of the State University of New York using the product. So you see widespread distribution of our product and even into the retail channels that we mentioned in our prepared remarks. So that is clearly the breakthrough, and that's why we're so excited about the progress and growth in our molecular collections, Molecular Solutions business unit and that will continue into 2021 and beyond.

Great. And then maybe one for Roberto. We saw gross margins came in at 63%. It's definitely a nice contributor to flipping the model back to a profitable fourth quarter. I was curious if you could comment on that level of margins given the increasing mix of molecular collection and the expected continued momentum behind this business?

Sure. So, you correctly deduced that the driver of that is the COVID-19 products and we continue to expect those to be growing contributors to our revenues. So versus the third quarter and the fourth quarter, in the fourth quarter we expect gross margin to be at least as good as the third quarter and likely a bit better given the historical seasonality in our commercial genomics business. There will be some moderation to the gross margin as we see continued growth in our HIV international business, which is a lower gross margin business. But we do overall see this as a sustainable gross margin level that will see some seasonality from quarter-to-quarter in the coming year.

Great. Thanks for taking the questions and congrats on the progress this quarter.

Thanks, Frank.

Thanks, Frank.

Thank you. Our next question comes from the line of Tycho Peterson with JPMorgan. Your line is now open.

Hi guys, this is Casey on for Tycho. I guess first question I have is – are you guys baking in any COVID antibody revenue into your Q4 guide? And then how do you see the market evolving for this test? I guess how much of an advantage is perhaps using oral fluid? How much of a competitive advantage is that?

So, Casey, we have not broken out individual products into our guide for $55 million to $60 million. But I think, as we announced back in August, once we locked prototype on the antibody test we would begin building inventory that is manufacturing at risk. That has come to fruition. We have customers that are now evaluating our product on a research-use-only basis before we get our EUA. So that's moving along nicely. I think the market for this oral fluid antibody test is going to be expansive. It's coming at a great time when the discussion in the pandemic has moved towards seroprevalence and surveillance. There was an article out just today that said that there's probably 20% of New York City residents that have been exposed to the disease but they haven't been counted or measured yet. So we really do not know the seroprevalence possibilities for our product in 2021 and 2022. In the rollout of a vaccine, this will be a powerful tool to accompany the vaccine to see how much of the population are mounting antibodies to this virus overall. So, and we know from our own experience with genomic testing that oral fluid sampling is a lot better than blood-based sampling. And this is the only product, if and when it's approved for EUA by the FDA, to use an oral fluid. I think there are over 300 antibody tests that use blood. So it – in the tradition of OraSure, these are unique products with unique applications.

Got it. Thanks for that. And maybe just one on the antigen pushout. Just sort of a little more color on the reasoning behind it. I saw last week the FDA updated its antigen test template that called for more studies to be submitted in the asymptomatic population. Just wondering is it a matter of more studies that need to be done? Or was it about getting the sensitivity up to where it needs to be? Just any more color on the reasoning behind the pushout?

Well, of course, when you're doing product development, there's always an iterative process involved with it. And then you add to that the need to get clinical data from the field. So that interplay between, let's say, change in the chemistry and changing aspects of the design of the product to get to the point where we are comfortable with it, I think contributed to the new forecast for the first quarter of next year. And I think that ultimately, the pushout won't matter to us commercially because I think we're very confident that once the product is on the market we'll sell as many as we can make. So it has nothing to do with the external factors of what FDA is doing and everything to do with our own standards of performance. And as I said before, we are the only company that's designing a product specifically to ultimately be a self-test whether it's an Rx self-test or an OTC self-test and designing those principles into the professional use product for which we'll seek the initial EUA. So to do all those things to create a one-step rapid antigen test is a challenge that's not been accomplished by anybody yet. So that's why we're investing the time and effort to do it right.

Okay. Thank you.

Thank you, Casey.

Thank you. Our next question comes from the line of Andrew Cooper with Raymond James. Your line is open.

Hey, thanks for the questions, guys. I guess maybe first on the antibody test and thinking about sort of the demand there. I know we've touched on it. But if I think back to when you guys initially talked about it I think the statement was this was somewhat pulled from your substance of user or risk assessment customers saying 'Hey we've got empty labs and we can do this.' Has that expanded potentially as you're approaching that getting it to market hopefully to additional customers potentially kind of bringing your platform in and your place and going beyond sort of those labs? Or how do we think about the commercial opportunity there?

Yes. Andrew, you've recounted our previous statements correctly. And I think you're also right that we've moved even further beyond that with commercial opportunities. And I think the reason for that is that the use and need for antibody tests has changed since the pandemic first started back in March. And as I said earlier, we are now at a stage where antibody tests are going to be more important than they were in the beginning of the pandemic, particularly with prospects of a vaccine coming into play here. So with that in mind, there's a lot more commercial interest than we started from and we are pursuing that as I said with research-only customers right now in the queue in anticipation of the EUA for the oral fluid antibody ELISA test. So yes, things are moving along and we're seeing a lot of tailwinds for this part of the business.

Okay, great. And then maybe just quickly on antigen side. Just want to confirm like you said for antibody, like you said before kind of that manufacturing at risk comfort. Is that still the plan once you do have the final design locked in and sort of know what you're submitting to the FDA that you would still start manufacturing as soon as that's done?

Yes. That is still the plan. And based on significant inbound interest there is very good reason for doing so. We want to be able to satisfy pent-up demand in the marketplace. And as I said, the design of the product which aims for ultimately a self-test even though the first EUA is a professional test is something that will be unique in the marketplace.

Okay. And then maybe just one last one if I could sneak it in. On that understand that there is some of the kind of timeline dynamics that have adjusted. But when we think about running some of the trials in parallel, does delaying the professional test maybe push the over-the-counter or the prescription self-test closer to that initial timeline? Is there any chance where you can kind of compress the gap between the two as you've had more time to develop some of the data and fine-tune things? Or is it still kind of the same sort of lag here that we might expect as you go from one to two to three?

Well, the lag period is somewhat in our control as you can imagine with the design and resourcing of clinical trials, but it's somewhat out of our control because, of course, FDA makes the final call on the EUA approval process, right? So we're doing everything we can to ensure that there's minimal time between the EUA submissions and hopefully the approvals. We have evolved our thoughts thinking a lot about what it will take to accomplish these clinical trials and we'll make the investments we need to ensure that we shorten the time as much as possible. So I think that's been an evolving set of priorities for us since we spoke at our second-quarter earnings call back in August. And so I think we're in a very good position there to minimize the amount of time overall and control what we can control.

Okay, great. I’ll stop there. Thanks again.

Thanks, Andrew.

Thank you. Our next question comes from the line of Patrick Donnelly with Citigroup. Your line is now open.

Thanks guys. Steve maybe just following on on the capacity side. I mean with the Q1 launch obviously kind of ramping at risk a little bit ahead of time, what type of capacity should we be expecting upon launch of the self-antigen test? I know you talked about expectations of selling pretty much everything you guys can make. So how are you thinking about capacity? And then at the same time, are you thinking about carving that up and directing a certain amount of capacity towards professional, prescription, OTC? What's the right way to think about that from your side?

We are on track with our previous announcements, planning to increase our tests from 35 million per year to 55 million by the first quarter of 2021, and then to 70 million per quarter by the third quarter of 2021. This capacity includes about 17 to 18 million units per year for our existing HIV, HCV, and Ebola tests. Once we are ready to serve the professional market, we will have sufficient capacity based on prior information. We expect to sell as much of the professional products as we can produce. As we gain more clarity on the timelines for the prescription and over-the-counter self-tests, we will start making decisions on how to allocate capacity for these products. We see a strong demand for self-tests, whether prescription or over-the-counter, and we will adjust our production strategy accordingly. Our design approach is focused on maintaining the same form factor and product design across all three use cases: professional, prescription self-test, and over-the-counter self-test. This strategy is unique in the market and allows us to have a flexible production discussion.

Okay, yes, I think I understood most of what you said, even though I lost you toward the end.

Sorry about that.

I have a question regarding the antigen self-test. I apologize for bringing it up again, but I want to clarify the timeline. Last quarter, you shifted from using saliva to a lower nasal approach. I just want to confirm that the design is fully finalized now and that you're currently refining things on your end. The data appears strong, and there aren't any major changes expected except for the usual adjustments in a few months. Is that correct?

That is basically correct, although we haven't announced prototype lock or anything like that. And we may not announce that. I think our goal is, at least, right now, to announce when we actually submit the EUA for the professional application. But I think we're comfortable with our progress, without revealing too much about what the final design will look like. And because we've had experience with HIV, HCV, and Ebola, I think we know a lot about how to scale the manufacturing from there.

All right. Thanks.

Thank you, Patrick.

Thank you. Our next question comes from the line of Jacob Johnson from the line of Stephens. Your line is now open.

Hi. Thanks. On COVID-19 collection kits, can you just talk about what you're hearing from customers in terms of near and long-term demand for their tests? I think, given your fourth quarter guidance, it would suggest that demand is pretty strong, at least in the near term. But I would just be interested in any other color there.

Jacob, I would say that, we are approaching a point where we will sell everything we can make and the capacity increases that we forecasted back in August will serve us well. And so, we are seeing a rather insatiable demand for our products for molecular testing that we believe will continue, certainly, through 2021 and probably well into 2022. It began certainly in North America and in the U.S., but we're looking outside the U.S. as well right now. So these are great discussions to have, because I think people have really gravitated to the fact that you need saliva and self-collection saliva as a key part of testing.

Got it. That's helpful. And then, just maybe one question on the non-COVID front. You had a nice rebound in the HIV franchise in the quarter both internationally and in the U.S. I guess, on the domestic side, are you beginning to see signs of clinics reopening and domestic test volumes increasing? And then a quick little aside there would be with the, I guess, third wave as you described it in COVID here in the U.S. Should we think of, I think, Roberto said fourth quarter you expect to be better than the second quarter. But could we see maybe some of that rebound be muted here in the fourth quarter with COVID cases ticking back up?

Yes, we are noticing some improvement in our U.S. based HIV business, as Roberto mentioned. This is partly due to the CDC's guidelines encouraging clinics that have closed to refer potential patients to our self-test. Having this option available has worked to our advantage. Additionally, if there is a third wave of COVID that leads to another shutdown, it could positively impact our OraQuick HIV in-home test sales in the U.S. However, we prefer to focus on the economy and the continuity of clinic operations, which would favor our professional products. While we haven’t provided specific forecasts by product line, this is our perspective on the situation, and we see potential for growth in both scenarios.

Got it. That's helpful. Thanks for taking the question.

You’re welcome.

Thank you. Our next question comes from the line of Brandon Couillard with Jefferies.

Thanks guys. This is Matt on for Brandon today. Quick one on the Phase 1 rollout of your antigen test into the professional market. Any updated color on how you're thinking about ASP there? And then as well on the gross margin side given the initial customer will largely be in the setting of doctor offices or university health centers that are likely to go through distribution channels. Any color there on the margin side as well?

Roberto, would you like to take that one?

We haven't announced the pricing for the antigen test yet, but we expect it to be consistent with other products on the same technological platform and with general market products. We anticipate that the gross margin percentage will be at least comparable to our other products. It's important to note that due to the various product types and distribution channels, the actual average selling price and gross margin will depend on the mix among those options, which will change as we obtain the emergency use authorizations for the products and optimize the offerings for our customers.

Makes sense. And then Stephen if we look at the balance sheet you guys have $260 million of cash. You've done a number of smaller deals here, one divestiture. You're clearly spending right now to build out manufacturing, but curious how if at all your M&A appetite has evolved over the last few months. And if anything in the funnel is perhaps more actionable today than it was coming into this year. Thanks.

Yeah. We continue to look for attractive opportunities to leverage our balance sheet. I think that our business circumstances have certainly changed with the COVID-19 opportunities. And it remains our objective to look at acquiring companies, products, technologies that are accretive to our overall growth strategy. But as we look ahead to 2021 and 2022, the growth is going to be, I think, fairly enormous at current course and speed. And so we'll be adjusting our expectations of business development and the size and types of deals accordingly. But the pipeline has been robust, I think, as you suggested, both with our own outreach and inbound interest from potential prospects, and we'll continue to look at that. Our balance sheet, I think, is stellar. No debt at all on the balance sheet. And I think that will lead us to some interesting opportunities in the very near future.

Super. Thank you.

You’re welcome.

Thank you. We do have a follow-up question from the line of Vijay Kumar with Evercore ISI. Your line is now open.

Steve, I have a quick follow-up regarding the antigen testing. Can you share what investors should anticipate in the coming months? Specifically, will there be any updates for The Street? I'm asking because we've seen a push to Q4, and now it's Q1, so I think investors would appreciate some interim updates. Additionally, when are the trials set to begin? Are these in-field clinical trials involving live cases since they require self-swabbing? Could that be contributing to the delay? Also, has the device prototype been finalized yet? Thank you.

Yeah, Vijay, we have not announced prototype locks. So we haven't said anything about that. I do understand the interest in our product and the product development. I mentioned earlier, in response to a separate question, that we do plan to announce the submission of our EUA application for the professional test. That's our plan right now. Beyond that we will have to see what we'll communicate and when. There are obviously some competitive issues that we have to account for in any particular announcement. But the delays are not due to any particular factor other than we had very high expectations for the performance of the product. And the clinical trials are running to validate the particular design and performance of the product. So that interplay has continued and ramped up since our August Q2 earnings call. So that will what I said before is that we will use what we understand are the standards for the FDA targeting a self-test and our own internal quality and performance standard as the measuring stick. And that's a very high bar, which is why it takes time to get this product on the market. But we are very confident that we're on the road to getting this product to the EUA process in the first quarter. And following with the Rx self-test and the OTC self-test shortly thereafter.

Thanks, Steve.

Thank you, Vijay.

Thank you. This concludes today's question-and-answer session. I would now like to turn the call back over to Stephen Tang for closing remarks.

We'd like to thank everybody for participating on the call and your interest in OraSure Technologies. We hope that you keep well and safe wherever you are and continue to enjoy your afternoon or your evening. Thank you very much.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.