OraSure Technologies, Inc. (OSUR) Earnings Call Transcript & Summary

Good afternoon. My name is Jackson Lowrie and I'm with the JPMorgan health care investment banking coverage team. Welcome and it's my pleasure to introduce you to our next presenter, Stephen Tang, who's President and CEO of OraSure Technologies. Stephen?

Thank you, Jackson, and thank you for JPMorgan for this opportunity to share the OraSure story. Before we get started, I'll remind you that we'll be talking about forward-looking views, which contain uncertainty and are subject to forward-looking disclaimers such as this. I'd refer you to our full and complete set of SEC filings for a more fulsome account of risk and uncertainties. The OraSure family of companies is focused on capitalizing on the next generation of tools and services to assess and study health and wellness. Our innovative sampling tools, services and diagnostics unlock access to accurate essential information that advances global health and well-being. Our products and services help people understand what's in us, what's on us and what's around us. They include molecular sampling kits for the genome and microbiome, cutting-edge services and analytics, rapid test for infectious disease and tests for substance abuse. Many of these options were not available just a few years ago and are changing the face of research and health care. We have assembled a company that drives access to multiple layers of information and data to understand health, wellness and disease states. And we continue to build on that platform. Our 4 subsidiaries include DNA Genotek, the first mover in developing sample collection and stabilization tools to enable genomics and microbiome research and testing. Novosanis, which makes a device to easily collect biomarker-rich, first void urine that can be used to detect urological cancers and sexually transmitted infections. And CoreBiome and Diversigen, whose microbiome sequencing analysis are accelerating breakthroughs and discovery in the microbiome industry. Our acquisitions of Diversigen, CoreBiome and Novosanis, all executed in 2019, harnessed the innovation power of university start-ups to advance our activities in molecular sampling and services, strengthening our position into multiomics. This emerging area of life science and data analytics provides a multilayered examination of an individual's health by examining the different omes that include the microbiome genome. OraSure also continues to power infectious disease diagnostics in the global arena, bringing our easy-to-use HIV and HCV Rapid Test directly to the patient. Together, we offer differentiated products with competitive profiles in attractive large markets with opportunities, many of them in their earliest days. The following points highlight the investment case for OraSure. To start, we are leveraging our leadership position in molecular sample collection and stabilization devices to drive growth. We offer our customers a comprehensive end-to-end solution that encompasses tools, diagnostics and services, and we'll continue to expand into global markets with our OraSure HIV Self-Test and OraQuick HCV test. The 3 acquisitions we made in 2019 highlight our ongoing active M&A efforts. We see tremendous growth potential in new products and services focused on the microbiome and multiomics. Our ability to provide customers with both genomic and microbiome products and services is an important foundation for OraSure to become a leading source for multiomics tools and analytics. To optimize our performance, we continue to invest in manufacturing capacity and improve production efficiency across our business. A key driver of our future growth potential is our solid financial position. We have approximately $201 million on our balance sheet as of the end of the third quarter with no debt. We're always asking the question, how can we advance our business to drive our innovation growth strategy? Before I go any further, I'd like to touch on some highlights from our third quarter earnings call. The acquisition of Diversigen gives us market leadership in end-to-end microbiome sampling and services. Product revenues for our genomic business, excluding a large consumer genomics customer that changed their ordering patterns over last year, were up 30% from 3Q compared to 2018. Our microbiome business grew 81% over the same quarter a year ago, and we've seen a 35% increase in the number of customers who are using both genomic and microbiomic kits, supporting our multiomics vision. Global HIV revenues were up 16% for the quarter compared to 2018. We believe the new federal guidelines authorizing the use of oral fluids in drug testing within federally regulated markets will open up large potential market opportunities for us that we're currently not serving. And finally, we divested our cryosurgical systems business. Not only does this add up to a strong balance sheet, but it also allows us to prioritize our product portfolio and focus our resources on growing our core businesses, advancing our innovation growth strategy. We break our business into 3 segments: molecular sampling tools, molecular analytical services and diagnostics. Our molecular solutions business unit includes the sampling tools, services and analytics to help researchers and consumers explore and understand the human genomics and the microbiome. Our sampling tools provide reliable self-collection and stabilization of optimized samples that truly represent the in vivo state to ensure accurate data and optimal results. Think of it as quality in and quality out, all the way from the sample to the answer. Our focus is on quality, easy to use, regulatory rigor that enables our customers to translate their solid scientific discoveries into clinical applications. More than 8,000 customers in over 100 countries use our molecular products and approximately 4,000 peer-reviewed publications cite their use. Importantly, our products are backed by a strong intellectual property portfolio. Our flagship Oragene and ORAcollect products are the only FDA 510-cleared (sic) [ 510(k)-cleared ] devices for saliva DNA collection and stabilization. Our products are used by leading consumer genomics companies, clinical testing providers and academic researchers around the world for both individual testing and large population health studies. And they're noninvasive. That means anywhere, anytime collection with no finger sticks, blood draws or needles. As TIME magazine put it, we've done for DNA collection what Google did for web searches: made it ridiculously simple and efficient. There's an evolution underway in the consumer genomics market. Along with other players in the sector, we've seen a contraction in the ancestry submarket as players shift their focus and their ordering patterns. At the same time, we see a pivot from individuals who are primarily interested in their genealogy or heritage into more serious views of their health, which we call disease risk management. This includes your susceptibility to the disease, your carrier status for certain diseases and pharmacogenomic applications. That is, how your genes may affect your response to drugs. Disease risk management offerings typically require physician interventions or interpretation of the results. The majority of our top 20 molecular customers over the past 12 months, marked by the end of the third quarter, are in disease risk management. And the majority are ordering consistent or growing volumes of the product. Looking to the broader market, the number of genetic tests used for disease risk management increased 8% from 2018 to 2019. We see this growth continuing and expect that for the next 3 to 5 years, it will become the dominant offering within the genomics market. We also see double-digit growth in the companion animal and lifestyle sectors of the genomic testing market. Our involvement in population health studies remains strong as well. One example is the Gen V project in Australia, a broad population study in which genetics is a slice and an option. Researchers at the Murdoch Children's Research center are asking patients of newborns across Victoria to safely and securely share information about themselves and the health and development of their newborn. The project will give researchers a complete picture of the health and well-being of a whole generation and unlock discoveries that improve the lives of families. They will use our ORAcollect kit to collect up to 390,000 saliva samples. The microbiome business, which includes products and services, continues to be a growth driver for our molecular business. Overall, it was up 81% in the third quarter compared to the same quarter 2018. Scientists are studying how the microbiome influences human health and diseases, such as colitis, diabetes and cancer. There's a staggering amount of diversity in the human microbiome, and the pace of microbiome research continues to grow. In 2019, we saw over 14,000 peer-reviewed microbiome-related research articles, a 30% increase over 2018. One major study estimates that 45 million unique genes just in oral and gut bacteria compared to only 20,000 genes in the human genome. Another study found that close to 100,000 new strains of bacteria live in the human body. Some of these genes and strains play a critical role in personalized medicine, yet the vast majority have not been well-characterized yet. Many indicators highlight the growth and opportunities within the microbiome market. NIH funding for microbiome has grown 36% over the past 5 years. Then looking ahead, multiple research projects project the CAGR of 16% for the microbiome market from 2019 through 2024. OraSure offers the gold standard in microbiome sampling kits and runs the world's leading microbiome analysis platform. Our collection devices are used in a variety of cutting-edge academic and commercial applications, assessing everything from how diet, lifestyle and the gut microbiome influence inflammatory bowel disease, to the first and largest study looking at genetics and microbiome in bulimia disorders. We will continue to invest in developing the latest tools, algorithms and genomic services to pave the way for more actionable microbiome discoveries. Together with DNA Genotek, CoreBiome and Diversigen, they all offer customers a unique, holistic and currently unmatched offering from sample to answer. Today, they address a market opportunity from research to pharma to clinical to environmental analyses. Each market is in the early stages of capitalizing on the power of microbiome discovery. So let me unpack that a bit for you. DNA Genotek brings to the table its gold standard kits that stabilize samples in ambient temperature for a true snapshot of the microbiome with no cold chain required. Together with CoreBiome and Diversigen, they form the ideal microbiome service company with the most comprehensive offerings to meet the needs of this emerging industry. Their technology provides deep analytics of microbiome samples. CoreBiome has refined microbiome analytics and machine learning or artificial intelligence to get better results and insights to their customers. For example, in December, CoreBiome announced a collaboration with Prescient Metabiomics to develop a breakthrough test that may represent a paradigm shift in colon cancer screening and prevention. Prescient will use CoreBiome's shotgun metagenomic DNA sequencing machine and machine learning and AI-driven microbiome analytics to accelerate their development pipeline. And addition of Diversigen to our portfolio strengthens our pharmaceutical customer base. 90% of Diversigen's customers are big pharma as well as leading microbiome therapeutics companies. The Diversigen team adds capability and capacity to meet the unique requirements of these large customers who are leading the way in demonstrating the clinical utility of microbiome-related discoveries. The combination of skill, expertise and thought leadership represented by these 3 companies means that we are effectively the leader in end-to-end solutions for the microbiome. And we're also creating a sound foundation for our multiomics future. As I noted earlier, multiomics is the emerging area of life science and data analytics to provide a multifactorial examination of one's individual health by examining the different omes, including the microbiome and the genome. Multiomics lets us integrate data from large populations to potentially impact prevention, improve diagnostics and more effectively, treat complex diseases, such as cancer and diabetes. We see this as an area of great promise for OraSure overall. This field is in infancy, making it hard to quantify. However, one good indicator is the 60% compounded growth rate in multiomics publications over the past 5 years. Currently, we enable multiomic analysis by providing gold standard collection and stabilization in analytical surfaces in multiple omes as I just described. An early indicator of customer activity in multiomics is the number of customers that have used both our genomic and our microbiome products and services. At the end of the third quarter, the number was up 35% year-to-date. We will continue to evolve our multiomic strategy to maximize the potential for this emerging area. We have a solid network of customers and endorsers for whom we are confident these offerings are of great interest. Turning to diagnostics. OraSure is committed to solving the world's most complex diagnostic challenges. Our trailblazing products include: the first oral fluid HIV test for professional use, the first and only rapid HIV in-home test approved for over-the-counter use by FDA and for use in the U.S., the first oral fluid HIV self-test prequalified by the World Health Organization for use in emerging markets and the first FDA-approved CLIA-waived rapid hepatitis C test. And our OraQuick Ebola Rapid Antigen test recently received FDA clearance in October. Looking at HIV, the vast majority of the 38 million people around the world living with HIV are in low and middle-income countries. We are the dominant player in the international HIV self-test market with 95-plus percent share position. We've seen the market grow by strong double digits over the past 2 years and expect continued double-digit growth. As the first WHO-prequalified HIV self-test and the only oral test, we're leading the way in self-testing. Working with partners such as the World Health Organization, Unitaid and the Gates Foundation, we are solving this public health challenge by enabling large programs to take HIV testing out of the clinic and into the communities. The success of our HIV Self-Test is based on convenience of use, the accuracy of the test and the ability to administer it privately. And we offer the benefit of oral fluid sample capability, which sets us apart from blood-based tests. This is especially important in areas like sub-Saharan Africa without developed health care infrastructure in place. Public health care workers in low-resource settings can literally put our test in their backpacks and take them door-to-door, where people can be tested and linked to care if they're HIV positive. This privacy also mitigates the fear of stigma that can keep people from seeking diagnosis. I'm proud to say that we are moving the needle tremendously. Thanks to the STAR, Self-Testing in Africa program, it's estimated that 81% of people with HIV in sub-Saharan Africa are now aware of their status. That's up from 45% in 2014 before the initiative began. Additionally, as a result of the positive data generated by STAR, HIV self-testing is expanding into Asia, Central Asia, Latin America and Eastern Europe. Along with global health partners, we're working to enhance diagnostic testing for children as part of the Rome Action Plan for pediatric HIV. Last year, we received approval for WHO change notification to allow for testing of individuals 2 years and older with the WHO-prequalified OraQuick HIV 1/2 Rapid Test and the OraQuick HIV Self-Test. This approval will allow doctors in professional settings as well as train health care workers in any setting to test children 2 years of age and older. This will enable a broad use of these tests in hard-to-reach pediatric populations. Looking at the market opportunity, Unitaid in WHO's 2018 report on the HIV self-test estimates the global HIV self-test volumes will grow in a range which averages out to 16 million tests annually by the end of 2020. This report projects the high end of that range to reach just over 19 million tests. In March, the Journal of International AIDS Society published a report on the potential of HIV self-testing in Africa and lessons learned from the STAR program. The report concluded that the new testing paradigm, based in part on HIV self-testing, is a key part of the HIV response over the next decade and will be critical to achieving 95% diagnosis in broad geographic markets during that period. HIV is also a significant challenge here in the U.S., where approximately 1.1 million people are living with HIV. An estimated 39,000 Americans became newly infected with HIV in 2016 and about 1 in 7 are unaware that they're affected. Our nation is about to embark on the administration's Plan for America, a bold step in what we hope is the final push to eliminate HIV transmission in the U.S. Congress has approved $291 million as the first step in the administration's effort to end transmission by 2030. Diagnosis is a key pillar in the Plan for America. Reaching the difficult-to-reach segments of the population will be key to achieving its goals. Rapid testing that can be brought into the communities is seen as an important tool. With the only FDA-approved in-home or self-test in the U.S. market, OraSure is well positioned to play a key role in this initiative and capitalize on the market opportunity it represents. Domestically, we're working with the Center for Disease Control and public health jurisdictions to maximize the use of in-home or self-test to diagnose the hard to reach. We're also leveraging the strength of our complete portfolio, HIV, HCV and in-home, to offer more complete solutions and targeted accounts. We were encouraged by a letter from SAMHSA, the Substance Abuse and Mental Health Services Administration, recognizing that oral fluid testing represents a significant opportunity to increase HIV testing. SAMHSA encouraged programs not currently conducting on-site HIV testing to integrate oral fluid rapid HIV test to make this a routine component of the substance abuse disorder treatment. People living with HIV are twice as likely to have a substance abuse disorder than the general public. This critical intersection between the HIV epidemic and the opioid epidemic has led to an increase in hepatitis C or HCV. Globally, 71 million people have HCV today, and thankfully, there's a cure. In the U.S., it's estimated that more than 3 million people have chronic HCV and the majority don't know it. Up until recently, HCV has primarily afflicted baby boomers. But due to the opioid crisis and associated needle sharing, the rate of HCV has increased and the affected group has moved beyond the baby boom generation to younger people as well. We're also seeing funding geared towards testing and treating veterans. Congress and the administration have earmarked significant funding for both HIV and HCV domestically, providing a good market opportunity for OraSure. The final fiscal year 2020 spending bills includes $291 million for the administration's HIV elimination proposal as well as $39 million for the Division of Viral Hepatitis and $10 million for opioid and infectious disease elimination efforts. Domestically, our HCV point-of-care test is the only point-of-care test available. So we have 100% of that market. Our HCV revenues were up 9% through third quarter's compared to the previous year. We believe, eventually, there'll be global testing efforts that will mirror the programs currently in place to eliminate HIV. Our rapid tests are ideal to play this role in these programs as they support outreach testing in low-resource settings. I'd also like to touch briefly on our substance abuse testing business, where we see great opportunity. Drug abuse has taken its toll in the workplace. A staggering 70% of the estimated 14.8 million Americans who use illegal drugs are employed. Financially, there's a hefty bottom line impact. Drug abuse cost employers $81 billion per year. We were encouraged when SAMHSA issued new guidelines last fall permitting oral fluid drug development in federally regulated workplace settings in other markets that follow the federal guidelines, none of which are currently served by OraSure. SAMHSA estimates that the percentage of drug testing performed with oral fluid testing will grow from about 7% today to 25% in 2025. Our team of scientists pioneered oral fluid testing for substance abuse. Our technology provides accurate and easy-to-administer drug testing methods to help determine the presence or absence of drug or alcohol in a person's system. The newly endorsed use of oral fluid testing enables better detection of recent drug usage as it can differentiate between recent drug use and the historic drug use to effectively determine potential impairment on the job. Oral fluid testing can also make it easier, less costly and more efficient to collect a reliable sample over urine-based testing. So in summary, we are cultivating business development opportunities that advance our innovation-driven focus by adding differentiated products and services that we expect to enhance our business lines and growth profile. We're expanding our product portfolio into new products that build on our core strengths in genomics and microbiomics and move deeper into multiomics. We see significant growth opportunities in genomics, microbiome and eradication programs for HIV and HCV. We have robust manufacturing capabilities and a strong balance sheet to support our business development programs. Recent scientific breakthroughs offer significant growth opportunities, and we intend to leverage our strength and relationships with existing customers by expanding our portfolio and products synergistic with existing ones. So in closing, we remain optimistic about our future and our markets and especially since they are so vast and early in their development. I thank you for your kind attention, I look forward to your questions next door.

Good afternoon. This is the question-and-answer session for OraSure Technologies. I'm Steve Tang. I'm the President and Chief Executive Officer.

And I'm Roberto Cuca, Chief Financial Officer. Any questions?

Could you just give us a general overview of how the M&A landscape is after your 3 acquisitions so far? And how do you view the opportunity set over the next 12 to 18 months?

So the question is, what's our outlook for M&A given our 3 acquisitions in 2019. So as we reported at the end of the third quarter, we have $201 million of cash on our balance sheet and no debt. So our firepower is substantial. We continue to look for acquisitions of products and services that are accretive to our innovation-based growth strategy. The 3 acquisitions in 2019, I think were of what would be described as a tuck-in type variety. They're emerging technologies, both products and services. We certainly will continue to look for companies like that. We are also equally delighted to look at possibilities on our infectious disease side of the business as well. So far, the acquisitions have been on the molecular side of the business. And as far as the size of the deal, we're also open to larger deals as well. Obviously, larger deals have to be not only accretive to the growth strategy, but also accretive to the bottom line as a consideration. So we still view it as a very target-rich environment across our core business and adjacencies to our core business. But as I expressed in the presentation, we also have a view of a multiomics future, which are capabilities which may go beyond where we are today.

Have the opportunity set evolved at all in the last 18 months or so since you started looking? Like are valuations higher, lower in the sizes that you're looking for?

I think we're aware of evolution over time. I don't think anything has discouraged, either our pursuits or our valuation of companies over time. We've continued to say that we want to do the right deal at the right time at the right price. And so we still have the discipline around those 3 tenets.

And then when you say accretive on the bottom line, does it have to be immediately accretive? Or is it something that can be accretive down the road in years 2, 3 or 4?

So the question was for accretion on the bottom line, does it have to be immediately accretive or eventually accretive. For a larger transaction, we'd want that to be accretive immediately. For smaller transactions of the kind that we did in 2019, we're willing to take some dilution and help grow and evolve those companies to achieve profitability in the near term.

Can you tell us about your substance abuse product with the oral fluid? Is that product in the market? Or is that under development? Or what's the status there?

So the question is about our substance abuse testing business and a bit of the background and what the prospects are. We have had a substance abuse testing product line for some time, goes back to the origins of the company and actually, the collection device to enable those assays. We added to that rapid assays over time, which are largely used by insurance companies and by employers. So typically, on first day of work, you fill out your I-9 form and then you take a test. In our case, it's a rapid oral fluids test. So we've been in that business. I think the most recent development, which we cited in the presentation is that the federal Substance Abuse, Mental Health Services Administration, SAMHSA, issued guidelines that said the next generation of products can include products that use oral fluids versus using urine as the analyte. That's significant, as I covered in the presentation for 2 reasons. Number one, it's easier to trace the chain of custody with an oral fluid than it is with a urine-based sample. There's been a rise, unfortunately, in adulterated urine being tested instead of 1-zone samples. The other reason is that oral fluids actually give you better recency of drug use. Urine samples can give you a historic view, but you can't really tell whether the individual had been abusing drugs 30 days ago or 30 minutes ago. So it's a much higher quality test and we're intent on playing into that federal regulatory marketplace. As I mentioned in the presentation, today, only about 7% of drugs of abuse testing are done with oral fluids. That is, by several studies, is estimated to rise to 25% by 2025. So we see this as in line with our innovation-based growth strategy, and that's why we're investing to play in this market.

Are you the only player with the oral frame for substance testing? Or have you seen others there?

There are others, but I think we are widely used by employers and by insurance companies.

Why do you suppose no other company has been able to develop an HIV self-test?

So the question is, why hasn't any company been able to develop an HIV self-test. That's probably best addressed by those other companies, I think. But from our perspective, I think that we have held ourselves to incredibly high standards from both a quality, sensitivity and specificity perspective. It's the same quality that's been engineered in our product from the beginnings, which was a professional-use-only product, all the way to becoming the first FDA-cleared product for over-the-counter use, which is still the only product since 2012 since it was approved. We took that same approach to developing the self-test for the international marketplace. And we're still the only WHO-prequalified oral test in the market today. So I really don't know why nobody else has emerged. There are 2 WHO-prequalified blood-based tests. But so far, no oral-based tests. We obviously monitor the situation very carefully because we have such a high market share of the global self-test market. But I think we've set the bar very, very high for competitors. Any other questions? With that, we thank you for your continued interest in OraSure and thank you for your questions here today.

Thank you.