OraSure Technologies, Inc.

Welcome to the OraSure Technologies Incorporated 2021 Second Quarter Earnings Conference Call. My name is Adrienne, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star then 1 on your touch-tone phone. I'll now turn the call over to Scott Gleason, Head of Investor Relations at OraSure. Mr. Gleason, you may begin.

Thank you. Good afternoon and welcome to AuraSure Technology's second quarter 2021 earnings call. I am Scott Gleason, the Senior Vice President of Investor Relations and Communications. Presenting for AuraSure today are Dr. Steven Tang, our President and Chief Executive Officer, and Roberto Cuca, our Chief Financial Officer. As a reminder, today's webcast is being recorded and a slide presentation accompanying the webcast can be found on the Investor Relations website. Before we begin, You should know that the call may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings, or loss per share, and other financial performance, product development, performance, shipments and markets, business plans, regulatory filings, and approvals, expectations, and strategies. Actual results could be significantly different. Factors that could affect results are discussed more fully in the company's SEC filings. including its registration statements, its annual report on Form 10-K for the year ended December 31, 2020, its quarterly reports on Form 10-Q, and its other SEC filings. Although forward-looking statements help to provide complete information about future prospects, listeners should keep in mind that forward-looking statements are solely based 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'm pleased to turn the call over to Dr. Steven Tang.

Thanks, Scott, and thank you to everyone for joining our call today. This quarter, Warshaw saw an exceptionally strong recovery in our core business, and excluding COVID-19 product revenue, we grew 122% year over year and 48% sequentially. And while we still have a ways to go, the beginning of the return to a more normal activity for our customers is a welcome sign as we look to the second half of fiscal year 2021. The strengthening of our core allowed us to achieve strong financial results despite the anticipated slowdown in molecular solutions COVID revenue as PCR test volumes declined in the U.S. This quarter, we also achieved a major milestone with the receipt of three emergency use authorizations, EUAs, for our IntelliSwab COVID-19 rapid tests in the U.S., which we continue to believe will be a very important driver of incremental revenue and a source of growth for the company. The launch of our IntelliSwap test demonstrates the ability of the company to develop, launch, and market new products. And in the coming year, we will talk more about our renewed focus on innovation and our product pipeline as one of our strategic areas of focus. As we reflect on our strong quarterly results and our numerous COVID-19 launches, I would like to personally thank OraSure's dedicated employees around the world who have worked tirelessly to get us to this exciting point in our company's journey. I would now like to discuss our strategic priorities, which include capitalizing on the COVID-19 testing opportunities, expanding our sample collection and molecular services business into new sample types and testing modalities, and expanding our global reach and driving innovation with a focus on achieving higher growth through both internal R&D and M&A. First, as we look at the COVID-19 testing opportunity, this quarter we've received three EUAs for our IntelliSwab COVID-19 rapid tests for over-the-counter, OTC, professional point of care, and prescription home use. We believe IntelliSwab is competitively differentiated primarily because the test is remarkably simple to use. You just swab your nostrils with a gentle swab, Swirl the swab in a tube and see your test results in minutes. Unlike other rapid COVID tests, there is no confusing steps, no batteries, no electricity needed, and no mailing samples to a lab. We like to say it's as simple as swab, swirl, and see. Orsha knows this simplicity is absolutely crucial to adoption and ongoing use by consumers and clinicians. It ensures confidence in the results, and enables testing absolutely anywhere, including outreach testing to underserved communities, exactly where our HIV and HCV tests are used today. As is customary in medical device and diagnostics, the conversion of customer leads to purchase orders takes time. And recall that we were limited in our ability to promote this new product prior to receipt of our three EUAs in early June. So while we are in the initial phases of customer acquisition, we did begin shipping orders in June and continue to receive orders in July. We currently have customer inquiries representing over $25 million, including inquiries from over 15 countries that will accept FDA EUA product with appropriate country-specific documents and labeling. We believe the recent propagation of new variants has renewed the focus of global governments on a multi-pronged strategy to counter the pandemic consisting of vaccination, protection, and frequent testing. A study conducted by the National Institutes of Health and recently published in the Journal of Infectious Diseases indicated that antigen testing, when conducted every three days, has sensitivity equal to that of PCR lab-based testing. This supports the need for regular, fast, and frequent testing which will be needed in remote locations and at home. One of the most crucial requirements for this type of testing is the ease of use, and that's where IntelliSpa provides a real benefit. Our country's response to the pandemic is well characterized by the CDC program of protect, test, and vaccinate. We continue to believe that testing will be a critical component of the three-tiered response to counter the COVID-19 pandemic. As new variants such as Delta and Lambda propagate across the globe, there has been increasing demand for testing in multiple global markets. Additionally, as students return to schools and employees return to work, we believe testing will be vital for ensuring safety and hygiene for all. We've already seen several announcements around programs incorporating both vaccinated and unvaccinated individuals. Additionally, large funding pools have become available from the federal and state governments, including the CDC's $2.3 billion of funding for underserved and rural communities for which our test is ideally suited, an additional $1.6 billion from the Biden administration to address testing and mitigation in vulnerable communities, and $10 billion from the Biden administration to fund back-to-school testing. That adds up to $13.9 billion in federal funding to, in large part, address testing in congregate, underserved, and vulnerable communities. Places where vaccination rates are low and COVID-19 variants are now surging, and our IntelliSwab test is ideally suited. Lastly, as it pertains to COVID-19, I want to provide an update on our oral fluid antibody tests. The FDA recently responded to us and declined to further review our submission as they focused on areas of higher priority. However, we will continue to offer this product as a research use only test with several laboratories interested in COVID-19 antibody surveillance and research applications. Next, I would like to highlight one example of how we're trying to expand our sample collection business. As you know, we built the saliva sample collection portfolio by generating data to disrupt the standard of care for sample type, often blood, and then co-clearing our collection devices with relevant assays in the genomic space. We are now pursuing a similar strategy with first void urine collection with our Novacentis subsidiary, as we look to bring the non-invasive benefits of urine sample collection to new markets. This quarter, we had a significant publication in gynecologic oncology demonstrating the ability of Kali-P, Forrester's proprietary urine sample collection technology, to facilitate testing for human papillomavirus, HPV, using first-void urine samples from patients. In a study of approximately 500 women, the sensitivity and specificity of Kali-P-collected first-void urine samples was shown to be similar to the sensitivity and specificity of clinician-collected cervical samples using Abbott's real-time high-risk HPV assay for the detection of neoplasia. We have additional clinical studies in process with other major HPV test manufacturers that we expect to come out later this year. While there is still a significant pathway to full product validation and regulatory approval, we believe Colipi has the potential to transform cervical cancer screening to a better, less invasive, and more cost-effective modality. where women can have the sample collected for cervical cancer and other sexually transmitted diseases in the privacy of their own homes. The market potential for HPV screening represents greater than 30 million tests per year in the U.S. alone, making this a significant future opportunity. In regard to Colipi use for oncology, we also saw MDX Health, one of our top customers, using Colipi for cancer screening, receive a draft local coverage determination from Palmetto GBA, a Medicare administrative contractor, for their select MDX urine tests for prostate cancer risk assessment. Typically, these types of reimbursement coverage decisions are catalysts for more significant commercial adoption of laboratory tests. This was also a record quarter for our microbiome business in both the service and kit side, with over $6 million of total revenue. We now have over 50 commercial customers in microbiome testing, including over 30 biopharmaceutical companies conducting over 20 ongoing clinical studies. We're working with all the top five companies in the microbiome space, as well as five of the top 10 pharmaceutical companies in the United States. Early data around microbiome-based therapeutics has been positive, and some of these studies are beginning to advance to the phase three stage. with FDA, which will lead to increasing revenues as the number of samples evaluated increases. We also believe eventual regulatory approval of microbiome-based therapeutics will lead to further research investment in this area, which will benefit our business. Building on the growth of our microbiome business, in the second half of this year, we plan to offer a new gut metatranscriptome collection kit and metatranscriptome service in support of our customers' microbiome research. This is an important step toward the strategy of expanding sample types, analytes, and services as we pursue our multi-omic strategy. Another important strategic component of our molecular solutions business is expanding our long-term competitive position in the market. Investors have asked us about recent low-tech COVID-19 collection devices launched by other companies, and I believe it's important to highlight the unique features of our products. Our devices are designed for remote sampling collection for genetic sequencing. In addition to the well-proven, easy-to-use, consumer-friendly form factors, these feature proprietary patented designs and chemistries capable of stabilizing a variety of analytes under a broad range of storage conditions, allowing shipment and storage at ambient temperatures. Because the DNA and RNA is preserved, sample collection in our devices are suitable for surveillance-related sequencing, for variant detection as an example. While there are lower-cost devices in the market that can be used for COVID sample collection, they do not match our benefit profile. We continually innovate on both our physical design and chemistry, and as a result, have significant intellectual property protecting our technology, many with expirations extending out many years. Additionally, we are increasingly pursuing regulatory approvals in conjunction with our strategic customer relationships, such as the clearance received for our oral fluid collection device in conjunction with Helix for their whole exome test this year. Finally, we have established long-term contracts with some of our key customers, providing long-term visibility, and we are increasingly adding a broader range of services to customer agreements, such as fulfillment and customization services. Importantly, our customer base in these markets has become increasingly diverse. We have over 6,000 customers now with no single customer representing greater than 7% of our revenue in fiscal year 2020. Consequently, we believe we're in an extraordinarily strong competitive position as one of the global leaders in this market with our ability to address diverse markets such as consumer genomics, clinical genomics, and home testing, which are growing in the mid-teens, with our ability to expand our solution set to additional high-growth areas and sample modalities. Moving on to our strategy to expand our global reach and presence, we continue to see strong adoption of our Orquick HIV test internationally, driven by double-digit annual growth since 2016 of our HIV self-test, the only regulatory-approved oral fluid self-test for HIV in the world. We are already using our established distribution channels for HIV for the new IntelliSwab COVID-19 rapid tests, where we have inquiries from several countries as COVID-19 continues to spread outside the US. Across the Orsha portfolio, we continue to expand our global reach and now have over 400 product registrations in 95 countries. This not only applies to diagnostics, but also the molecular solutions. We're also looking to increasingly expand outside the United States with our collection kits using our COVID-19 collection devices. Finally, I'd like to discuss our strategic priority of driving innovation with a focus on higher growth spaces through internal R&D and M&A. I would like to provide some additional details relating to our business development efforts where we've been very active in assessing a number of opportunities and new technologies. From a prioritization standpoint, we're focused on companies and technologies which build upon the foundation of our existing business strategies and diagnostic and molecular solutions that would allow us to leverage our infrastructure and market expertise. In diagnostics, we recognize order-sure strength, and what sets us apart is our expertise in simpler, more effortless testing. With COVID-19, we saw in real time just how important this type of testing really is. So as we think about the future of diagnostics, Foreshore is ideally positioned to drive additional self-testing and more effortless testing at the point of care. We're actively investigating new technology platforms that can expand our menu of tests on a global basis and provide long-term competitive differentiation. With the molecular solutions business, we're really looking at innovative solutions which can expand our capabilities from a sample collection format expand our reach into new high-growth emerging areas of testing, further strengthening our competitive positioning, and expand the scope of data and services we can offer our clients. We ended the quarter with $229 million in cash and cash equivalents, and we believe there's significant opportunity to drive further growth and stockholder value through external M&A. Overall, I'm extremely excited about the outlook for the next 12 months at Oreshore. We're currently conducting our annual strategic review, which will incorporate both broad internal stakeholder input and outside expertise in order to ensure we're taking full advantage of the strategic opportunities in front of us. We will look to share the output of this review with investors when the review is complete, along with a broader look at the innovation occurring within our organization. And with that, I'm pleased to turn the call over to Roberto to discuss our financial results and outlook.

Thanks, Steve. I'm happy to review our financial results for the second quarter. First, from a top line perspective, we delivered total revenue of $57.6 million in the second quarter of 2021, compared to $29.3 million in the prior year, representing year-over-year growth of 97%. As a reminder, last year's second quarter was the most heavily impacted by the COVID-19 pandemic. However, as Steve previously noted, our core business excluding COVID-19 product revenue grew 122% year-over-year and 48% sequentially this quarter, representing a significant recovery and demonstrating meaningful progress in key areas such as domestic and international diagnostics, our consumer genomic sample kits, and microbiome kits and services. Total diagnostic revenue in the quarter was $19.3 million versus $10.4 million in the previous year, reflecting 85% growth. Importantly, this quarter we saw an improvement in domestic HIV, HCV, and risk assessment testing revenue as we start to return to pre-pandemic levels. Our international diagnostics business saw 89% growth in the second quarter versus the prior year and grew 8% in the first half of 2021 when compared to 2020. This strong growth was achieved despite two important headwinds. First, there were expected changes in the Bill and Melinda Gates Foundation subsidy for our HIV self-test, which have impacted revenue growth year to date. This subsidy ended in June 30th of this year, pursuant to the terms of our agreement with the foundation, and has been tapering downward for some time. In addition, as COVID-19 is now spiking across Africa, with many major countries in lockdown, our NGO customers have experienced in-country distribution challenges, which then caused delays in Q2 orders. Looking at our molecular solutions business, total second quarter revenue was $38.3 million, increasing 103% versus the prior year. We saw a strong rebound in customer activity in the consumer and clinical genomics areas. COVID-19 revenue in molecular solutions increased 36% year over year to $11.5 million, but declined by 58% sequentially as PCR testing rates in the U.S. decreased and customers lowered inventory positions. The non-COVID-19 portion of the molecular solutions business grew 61% sequentially, Looking back to the pre-pandemic period in the second quarter of 2019, our molecular solutions business grew 45% relative to that period, excluding COVID-19 revenue, demonstrating strong growth in the base business. Now I'd like to discuss our financial results, beginning with our gross profit percentage. Gross profit percentage in the second quarter was 53.2% compared to 59% in the same period last year. The decline in overall gross profit percentage reflects three factors. The first was product mix in the diagnostic segment with a higher proportion of revenue coming from the lower margin international business, coupled with the decline in the Gates Foundation subsidy. The second factor was the significant hiring and equipment purchases to date for the IntelliSwap launch, which do not yet have associated positive offsets from a revenue perspective. Finally, we did see higher material and labor costs in the quarter. From an expense standpoint, total operating expense in the quarter was $28.9 million, compared to $26.7 million in the second quarter of last year, reflecting operating expense growth of 8%. In the quarter, we generated operating income of $1.8 million, compared to an operating loss of $9.4 million in the previous year. Moving to the bottom line, we generated a net loss per share of 2 cents in the second quarter of this year, compared to a net loss of 16 cents per share in the same quarter last year. cash used in operations for the quarter was $3.4 million. Moving on to our financial outlook, given the continued volatility and unpredictability around COVID-19 testing, we are providing top-line guidance for the third quarter with some additional color on our full-year outlook. For the third quarter, we expect revenue of $45 million to $50 million. Additionally, we anticipate full-year intel swab revenue of approximately $30 million, with the preponderance of that occurring in the fourth quarter. This would position us to deliver full-year revenue of approximately $230 million. I'll review a few of the assumptions underlying our third quarter guidance. First, for IntelliSwab, although we currently have an installed capacity of 55 million tests per year manufacturing, we have faced some manufacturing challenges with respect to tech transfer. Although we are confident in our ability to rapidly resolve these issues, they will impact the amount of product available for sale in the third quarter. As the COVID-19 pandemic continues to evolve in the U.S., we have noted a declining pricing environment and have also factored that into our projections. Despite these issues, as we previously discussed, we've been receiving significant inbound interest and expect our book of business to continue to expand throughout the quarter. With respect to our molecular collection kits for COVID-19 PCR-based testing, we're assuming a significant sequential decline in revenue given current PCR-based testing trends. However, given the proliferation of new viral variants, the upcoming fall cold and flu season, increasing international sales, and funding for back-to-school programs where PCR testing is predominantly used for younger children, we believe there will likely be a rebound in our PCR kit sales for COVID-19 testing products this fall. So ultimately, this assumption could prove conservative. As we look to our fourth quarter, we would anticipate a significant sequential uptick in revenue as Intelliswap revenues become much more pronounced. Although our third quarter outlook is conservative, we are focused on establishing a revenue baseline that is achievable with the potential for upside if we outperform our current assumptions. With that, I'll turn the call back to Steve.

Thanks, Roberto. As a company, we are an exciting point in our history, and the progress we made from our fundamental perspective is beginning to become evident in our financial results. This quarter, we demonstrated the increasing strength of our core franchises with non-COVID revenue of $46 million, representing almost a $200 million annual run rate. That would be a historic high for our total revenue. We have now entered the commercialization phase with IntelliSwab. We remain confident that IntelliSwab will be a significant driver of revenue growth and free cash flow and also a long-term product for the company as we ultimately enter the endemic phase of the disease. Our molecular solution business is also increasingly strong-footing as we build out new products and service capabilities, increasing the number of sample types we can accommodate and expanding new fields of testing and end-use markets growing in the mid-teens. Finally, we are invigorating our innovation engine of the company and look to introduce new technologies through internal R&D, external collaborations, and M&A. Overall, we believe we are poised to emerge from the pandemic a stronger, more innovative, and faster-growing company. And with that, I'd like to turn the call back to Scott for questions and answers. Thanks, Steve.

Operator, we are now ready to begin the Q&A portion of our call. We would ask that you limit your questions to one question and one follow-up to ensure broad participation.

Thank you. We will now begin the question-and-answer session. If you have a question, please press star then 1 on your touchtone phone. If you wish to be removed from the queue, please press the pound sign or the hash key. If you're using speakerphone, you may need to pick up the handset first before pressing the numbers. Once again, if you have a question, please press star then 1 on your touchtone phone. And our first question comes from Vijay Kumar from Evercore. Your line is open.

Hey, guys. Congrats on the print here, and thanks for taking my question. My first question on the guide here, Steve and Roberto, I guess the $30 million of antigen testing revenues, what are you assuming for 3Q and Q4? If I look at your 3Q revenue guide of 45 to 50, the implied Q4 is about 65-plus. If all of antigen revenues are flowing through in Q4, then the base, implied basis, you know, 30, 35-ish, that seems to be a pretty dramatic decline versus your pre-pandemic level. So would you maybe just walk us through your second half assumptions between base versus COVID tailwinds?

Sure. Thanks for the question, Vijay. So I'll start off, and then Steve can jump in. So, as we mentioned in the prepared remarks, we expect that the preponderance of the $30 million in IntelliSwap revenues in the second half of the year will occur in the fourth quarter. So, given that, we haven't given exact guidance on how much we expect in the third and fourth quarters specifically. But you're right, there is a decline in the remainder of the business from the second to third quarters. The biggest driver of that decline is our lower COVID-19 molecular collection kit revenue expectations. As we stated in the prepared remarks, we've taken a conservative outlook based on current demand trends. And additionally, we're making some lower assumptions for some of the core products in diagnostics and molecular solutions following strong growth in core demand in the second quarter, which could have been driven by restocking or initial distributor purchases or clinic purchases. So we do expect to see a slightly lower third quarter than second quarter in some parts of the base business. Definitely a step down in the molecular collection devices. And as we discussed in the prepared remarks, some of the challenges in the tech transfer of the IntelliSwab manufacturing have delayed the availability of products such that we'll see most of our IntelliSwab sales for the year in the fourth quarter.

That's helpful, Roberto. And Steve, maybe one for you. You know, some recent articles on, you know, perhaps some, you know, other corporates or companies having approached Orsure. Now, I know you don't comment on market speculation, but can you, you know, the article did mention that, you know, Orsure has started a strategic review process. Can you... Tell us if you've started a strategic review process of the business.

Well, Vijay, I think as you know, we wouldn't comment on the veracity of any rumors, and so we're going to stand by that.

Gotcha. And maybe one last one, if I could ask. At gross margins, maybe what is one-timer here in 2Q, and should second half be in the low 50s, or should that normalize to 60-plus?

So the biggest driver of the step down year on year in gross profit percentage was the increase in our HIV international sales, which tend to be lower than the average of our gross profit percentage across the company, coupled with the decrease in the Bill and Melinda Gates Foundation supplement to those revenues. As we see growth from IntelliSwap over the course of the second half, which is likely to be a higher margin product and which we're likely to get better pricing on as we get deeper into the year, we should see some movement in the gross profit percentage. Thanks, guys.

And our next question comes from Patrick Donnelly from Citi. Your line is open.

Great. Thanks for taking the questions, guys. Just on the tech transfer issues impacting IntelliSwap manufacturing, I thought you guys were already manufacturing at risk. So can you just talk through, I guess, when the problem arrived and also, I guess, the path to resolving it? Are you already through it? It sounds like obviously with 4Q being bigger, maybe we have a little bit to go here. But just talk through, I guess, the steps necessary to get us to – you know, that 55 million of manufacturing capacity, or just in general, higher capacity, what you guys are doing internally there.

Yeah, Patrick, I'll start. So we have been increasing our capacity as we've been sharing quarter by quarter. We currently have installed capacity to produce 55 million tests per year, and we're installing additional equipment to expand it to 70 million tests per year this quarter. Our current production, as we announced, will be significantly lower than that until we can resolve the tech transfer issues. We have been manufacturing at risk. The issues that we're facing are one of scale-up as we are getting more volume online and trying to address issues in increasing that scale. So these are situations we have seen before in other product launches. Fortunately, the IntelliSwab design and platform is largely similar to our ORCWIC HIV and HCV and Ebola platform. So we've seen this type of situation before. So we're working to rapidly resolve that, which hopefully will open up more capacity in the fourth quarter.

Okay, that's helpful. And then I know you mentioned orders from, I think, 15 countries who kind of accept the EUA as approval. Can you talk about just broadly the opportunity, OUS? You know, what key markets are you still pursuing additional approvals in? Maybe just some timelines around the bigger ones that we should keep an eye out for.

Well, it's been, it's shifted, I think, as the pandemic has spiked in certain parts of the world. And so, as you would expect, countries that accept the FDA EUA as part of the authorization to sell in their country, where the virus and pandemic are spiking are clearly the ones in the greatest need right now. So that's where we're receiving the most interest in the hotspot countries, the 15 that I mentioned that have the ability to accept the EUA. Beyond that, we're looking at broader geographical coverage like the European Union. But quite frankly, we didn't expect interest this soon for our product We thought primarily this would be a domestic product, but it turns out the interest is purely global. So we're adjusting to that, and we're addressing those needs.

Okay. That's a good problem to have. So maybe last quick one, just on the long-term contracts and the sample collection, encouraging to hear that you guys established some of those. You know, I know competitive noise has been something you guys have talked about and investors always ask about. So, I mean, was this, in response to that, any change in terms of the pricing we should think about or any metrics you can give us in terms of what percent of customers are locked in? I know you said there were some key large ones, so just trying to get a feel for what that looks like. Thank you.

Well, so we have not seen significant price changes in the consumer genomics area. I think what we're pleased to see is that it's a rebound of not only the commercial genomics, but also the academic genomics businesses. So we haven't announced what percentage of our revenue base or customers are locked in per se, but it's a significant amount. And, you know, I think that the issues we had a few years ago with customer concentration are behind us. And so I think that It bodes well for the continued growth in the consumer genomics area.

Yeah, Patrick, we said, remember, on the call that we had the first 6,000 total customers. You know, it's really just the top ones that we have kind of the longer-term contracts with. But it's more about kind of the multiple strategies that we're engaging in in terms of, you know, getting regulatory approvals in conjunction with the customers, you know, expanding the IP portfolio. And so it's all those factors kind of combined that we think build a very defensible position for that business. Makes sense. Thank you, guys.

And our next question comes from Frank Tanken from Lake Street Capital. Your line is open.

Hey, thanks for taking my questions, guys. I'm not sure if I heard it did get on the call a little bit late, but I was curious about the broader capacity expansion plans that were put in place last quarter. Have those changed at all timeline or size-wise?

Hi, Frank. Thanks for the question. So our capacity expansion plans as far as installed capacity remain on track. So we do expect to, for example, for IntelliSwab, have installed capacity at the end of the third quarter of 70 million units per year. Again, that includes non-COVID-19 applications of approximately 17 million units a year. And the majority of investment for all of our capacity expansion efforts is largely committed. So we do expect to continue the capacity expansions on the same track as we previously described.

Got it. Okay. That makes sense. And then I just wanted to ask a little bit more of a broader question about the base business and its not meant to pin you down on any forward-looking growth rates or anything of that nature, but just wanted to kind of level set everybody on how we should think about the base business. And there's obviously a lot of moving pieces there, but maybe just talk a little bit through broadly how you think growth rates could look across infectious disease versus molecular solutions and maybe go into depth in some of your higher growth areas and some areas that you feel could produce some outsized growth and come a little bit under the spotlight as you look out over the back half of this year as well as into 2022.

Yeah, Frank, so I'll start. I think as we highlighted on the call, we still see strong growth in international HIV. That was strong first half growth over last year. That continues to grow, particularly in the number of units outside the U.S. We have sold over 23 million doses HIV self-test in 35 countries so far, so we expect that to continue. We're seeing renewed growth, as we talked about, in the consumer genomics area, particularly in disease risk management, companion animal, and lifestyle areas. We talked about the fact that the microbiome franchise, which includes sample collection kits and services, had a record quarter in their own right. And we had strong growth expectations for the microbiome business before the pandemic, and those look like they're continuing. So those are some of the areas that I would highlight. And obviously, we're just at the tip in the beginning of the COVID-19 IntelliSwab commercialization process. So that will be a growth driver as well.

Got it. Okay, that's helpful. That's all for me. Thanks.

And our next question comes from Brandon Corllard from Jefferies. Your line is open.

Hey guys, this is Matt on for Brandon. Thanks for taking the question. First one is just for Steven. Can you maybe talk a little bit about, you know, since you got the test approved back in June, the evolution of your talks with customers or potential customers and, you know, thinking, you know, big retail players, you know, academic education setting, which you've had success with your collection kits in the past, just where you're seeing the most interest and then talk about kind of the durability of that as we look into the back half of the year and into 2022. Thanks.

Yeah, certainly, Matt. So the conversations specifically on Teleswab have been very active, very robust. Many inbound inquiries. A lot of those have to do with back-to-school and back-to-work programs overall. And of course, separately, the sample collection area for COVID-19 has a strong base in back-to-school programs as well. So those continue. I think that what we've seen since we received our EOAs on June 4th is that, you know, we are kind of at the low point in testing from June 4th until today. And it's only in the past week or so where the concerns about the Delta variant and testing not only unvaccinated but also vaccinated people has come to the front. So we're seeing the pipeline increase over time. Now, since the product launch, I think there's been clearly a focus on asymptomatic testing and serial testing, in other words, selling products that can be used to test a single person in one instance and then testing them again in 24 or 36 hours. That's going to become increasingly important to avoid quarantines and shutdowns, and so I think we've entered clearly a new phase of the pandemic, and that's driving great demand for IntelliSwab. And as other products on the market are used and the differentiating quality of our product, which is ease of use, less than a minute of on-tans time for a customer to do the test itself, those attributes are really going to be difference makers. This is a dynamic market, and I think it's coming our way quickly, and we'll see that through the rest of the year, and I think we'll see an exit rate into 2022, which will be very favorable to us. Super. Thank you.

And your next question comes from Jacob Jacobson from Stevens. Your line is open.

Hey, thanks. Good afternoon, everybody. Maybe just one follow-up on the capacity side. On collection kit capacity, it sounds like from Roberto's comments, you're committed to still building this out. So can you just talk about the portion of that capacity that you need for non-COVID purposes? Maybe what could drive the non-COVID side higher as we look at a couple years? And then if we see limited COVID-19 collection kit sales, or maybe those sales remain limited in the near and medium term, you know, what would the plans for that capacity ultimately be?

Thanks for the question, Jacob. Yeah, so we remain on track with our molecular collections kits capacity expansion. And, you know, as you saw in this quarter, which was a quarter where the COVID-19 application of those collection kits decreased sequentially, the academic and commercial consumption of the kits increased. So we do think that there's pretty good elasticity between the two applications and we continue to drive growth of both consumer and academic use of those kits. So we expect that to the extent that we're not using them for COVID-19, there will be other applications that we can put those kits to.

Got it. Thanks for that, Roberto. And then maybe for Steve, and just maybe kind of moving back to the non-COVID side, on microbiome, obviously a really strong quarter there, I guess record quarter maybe. Can you just remind us of the microbiome assets that you have, their capabilities, and kind of your outlook for that end market?

Sure, Jacob. So our microbiome assets include the sample collection kits, as well as the service businesses, which we acquired a few years ago. So that's traded under the company name Diversagen. It actually is the merger of the Diversagen and Core Biome assets, which we acquired separately a few years ago. So that's a company that has a CAP certified laboratory, which essentially does the wet chemistry all the way through to the machine learning enabled data treatment. to characterize what is in that microbiome sample. So it's the type and percentage and number of microbes in that sample. A lot of the work is being done in the gut microbiome area, but we're also moving into the skin microbiome and industrial hygiene areas. And so as we've stated on the call, we have a large customer base for that service business, several top biopharmaceutical companies, products moving into phase three clinical trials. And so it's been a promising area for some time. And I think what we're starting to see is much more commercial activity on the services side, which coupled with the sample collection kits, I think is going to be high growth for us for the foreseeable future.

Got it. Thanks for taking the questions, guys.

And just as a reminder, to answer the queue, please press star then one on your touchtone phone. And our next question comes to Andrew Cooper from Raymond James. Your line is open. Andrew Cooper, your line is open. If you're on mute, could you unmute your phone?

Sorry about that. Double mute. Thanks for the questions and appreciate the chance here. Maybe just first, I think the area of biggest differentiation versus our model was in that genomic space outside of COVID. We know there was a big promotion event late June. Is there anything to call out to think about in terms of moving from that? Was it just kind of broad-based growth or anything kind of one-timish to think about when we think sequentially in that genomic space?

So I'll start, Andrew. Just nothing to call out. I think there's a normal seasonality. Both our product business and the royalties we receive for the collection kits for consumer genomics is driven by events like Amazon Prime Day. So I think that's been the same for for several years. Now, Amazon Prime Day was different in 2020 than it was in 2021, so that could be a slight difference, but I don't think there's anything inherent to that. I think we're seeing overall strong demand, particularly as academic labs reopen and as people become more interested in their health and what we call disease risk management, which is the genetic link to disease. So nothing that I would call out. Roberto, you have anything else you want to add to that?

No, I think you've touched on everything. The key there is that there were no one-time events. It just represented organic growth.

Andrew, one thing I'd just highlight, you know, when you look at that business from the kind of pre-COVID numbers, if you go back to 2019, we said it was up 45%, you know, which implies kind of a 20% CAGR. I think one trend you have seen is that business has become more diverse since we've had more customers. You know, obviously with some consumer genomics headwinds for some time, I think the consumer genomics side, as you can see in the news, is starting to do a little bit better. And so I think we're kind of starting to see the growth there, the opportunity, you know, in the market kind of come through in the numbers as well.

Okay, great. And maybe just one more kind of focused on IntelliSwab. You know, I like hearing the $25 million in inquiries you referenced. Is there any sort of timeframes you can put around, you know, what folks are looking at and how to think about that in context of, you know, talking about $30 million for the year and more 4Q loaded? Just, you know, how should we think about the duration of some of these conversations and, you know, what the structure might look like as they start to roll into the model and roll into the results?

Yeah, so, Andrew, I think overall there is very strong demand, and I think it's because we're entering this new phase of the pandemic. So I think the forward-looking view, to me, is much more intense than the backward-looking view because the backward-looking view includes this low in testing in the second quarter for just about everybody. So I think as we get more serious about how we can avoid quarantines and shutdowns, the need for testing will become much more apparent, and the need for self-testing will become important on top of that. And then on top of that, the attributes of IntelliSwap, which are its ease of use and the confidence a user can have in the results, that will factor in as well. So that's the comments we have looking forward. You know, some of the opportunities that are coming in that were included in that $25 million pipeline that we talked about are near-term and some are longer-term. And better yet, some are even short-term and long-term, which suggests a reoccurring sales over time. So we haven't given specifics on that, but our pipeline is actually increasing week over week as the concerns about Delta variant become very, very apparent.

Great. I appreciate the questions.

And we have no further questions. I'll turn the call back over for final remarks.

Thank you, everyone, for joining us today. And we appreciate your participation in the call.

Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating and you may now disconnect.