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JP Morgan 37th Annual Healthcare conference

Jan 10, 2019

Speaker 1

Good morning, everyone. We're going get started here. My name is Bob Rykowski. I'm with JPMorgan's Healthcare Group. Thank you all for being here this morning.

Just a quick housekeeping. There will be a breakout session in the Olympic Room after this presentation. It's outside the hallways. If you make two lefts, you'll find it on the right side of the hallway. With that, it's my pleasure to welcome our next presenter, Steve Tang, CEO of Oreshore Technologies.

Speaker 2

Good morning, everyone. Thank you, Bob. As Bob said, I'm Steve Tang. I'm the President and CEO of Oreshore Technologies. I'm delighted to be here with, so many of my colleagues.

Today, I'd like to share with you how we empower the global community to improve health and wellness by providing access to accurate and essential information. As I go through my presentation, please remember that our views of future contain uncertainty and is subject to this forward looking statement disclaimer. I refer you to our complete set of SEC filings for a more fulsome account of risks and uncertainties. I'd like to start by clearly stating our investment rationale. We are an industry leader in DNA, RNA, sample self collection, stabilization and preparation products and in rapid point of care infectious disease testing.

As you'll hear today, we have we see multiple growth drivers, many in the early stages of uptake and market growth. Our Molecular Solutions and Infectious Disease Diagnostic business platforms offer differentiated products with competitive profiles in attractive markets, and we see tremendous growth potential in new products and services focused on the microbiome. Our primary focus includes leveraging our leadership position in molecular sample collection and stabilization devices, expanding into new infectious disease markets and developing and acquiring new products and programs for large global opportunities. And we're expanding our molecular offerings to provide our customers a comprehensive end to end solution that encompasses tools, diagnostics and services. To optimize our performance, we continue to invest in manufacturing capacity and improve production efficiency for our major lines of businesses.

Also key to our future is the robust balance sheet. We have a strong cash position with no debt and sustainable profitability, which facilitates our active business development program. The identification, evaluation and acquisition of new products and technologies is a key priority as we continue to build our company. Later in my presentation, I'll share with you the two recent exciting acquisitions that highlight our active business development efforts. We have two major lines of businesses.

Our infectious disease division includes diagnostics for HIV, hepatitis C and Ebola as well as sample optimization reagents for tuberculosis. The Molecular Solutions side includes tools and services for human genomics and the microbiome. As you'll hear later in my presentation, our new acquisitions advance our activities in the molecular area. We've identified key drivers of significant growth for both of these strategic pillars. Let's take a look starting with infectious disease, where we have a sixteen year track record of innovation and success.

This track record began domestically with our OraQuick HIV test. It continues through to our OraQuick in home test, the first and only rapid test approved for OTC use by the FDA. Then we turn our focus to enabling large scale international opportunities with our HIV self test. We've leveraged this platform to provide diagnostic solutions for hepatitis C, or HCV, as it's called, and Ebola. All these products are built on a proven and reliable lateral flow platform.

This morning, I'll focus on HIV and HCV. Reliable, rapid testing quickly and easily lets infected individuals know of their status. This enables them to be quickly linked to care, preventing transmission and ultimately saving lives. Our AuraQuick HIV Self Test is the first oral fluid HIV Self Test prequalified by the World Health Organization, and our customers are using it to solve critical global health problem. Nearly four decades since the AIDS crisis began, there are still over thirty six million people living with HIV, and around a quarter of them are unaware that they're infected.

Many of them are in low or middle income countries. In Africa, for example, where nearly one in every twenty five adults is living with HIV. That's nearly two thirds of the people living with HIV worldwide. OraSure has helped solve this public health and sociological challenge by enabling large testing programs that are designed to take HIV testing out of the clinic and into the communities. There, health care workers can find, educate and test those individuals who are most at risk and least likely to seek out of clinic care.

The OraQuick HIV Self Test provides accurate results in twenty minutes. Its simplicity and ease of use is why it's been used by to test millions of people. We sold over 50,000,000 of our HIV tests for professional use, international self test programs and over the counter for consumer in home testing. Scaling the eradication of HIV worldwide requires capable and innovative global partners. OraSure is fortunate to have partners with impeccable credentials.

In 2017, we signed an agreement with the Bill and Melinda Gates Foundation to subsidize the cost of our self test in 50 countries in Africa and Asia. Thanks to this subsidy, countries can afford to buy the test to pilot, validate, and scale large self testing programs. We're also working with UnitAid, the funding organization which originated the Self Test Africa or STAR program and Population Services International, PSI. PSI is a world renowned nongovernment organization with 8,000 employees and programs in 50 countries. STAR Phase I deployed 750,000 units in three African countries: Zambia, Zimbabwe and Malawi.

It generated crucial information about how to distribute HIV Self Test products effectively, ethically, and efficiently. In 2017, the expanded STAR project launched with a commitment to deploy 4,000,000 units across Malawi, Zambia, Zimbabwe, South Africa, Lesotho, and Swaziland. By November 2018, the STAR initiative has distributed 2,300,000 HIV self test kits. It's estimated that eighty one percent of people with HIV in Sub Saharan Africa are now aware of their status. That's up from forty five percent in 2014, just before the STAR initiative began.

There are an additional 44 countries that are still eligible for the Gates subsidy. There's additional market opportunity in other parts of the world as well. Interest in self test range from smaller pilot programs to higher volume screening programs in over 40 countries. In addition to Sub Saharan Africa, we're working with Latin America, Central Asia, Asia and Eastern Europe. In third quarter twenty eighteen, a majority of the purchases that we sold were outside of the STAR initiative.

And Unit A and WHO's 2018 report on HIV Self Tests notes that the market for the global HIV Self Test volumes are estimated to grow in a range which averages out to 16,000,000 tests annually by the end of twenty twenty, with the high end of that range reaching just over 19,000,000 tests. On the domestic side, our OraQuick HIV in home, test is the first and only point of care HIV test with FDA approval for over the counter use. It's available online at realtors, including Walgreens, CVS, Rite Aid and Target. As we reported in our third quarter twenty eighteen earnings call, our global HIV business delivered strong performance with revenue growing 7% for the third quarter compared to the prior year. We've leveraged the Lateral Flow platform to develop a rapid test for hepatitis C or HCV, as it's called.

Globally, an estimated seventy one million people have chronic hepatitis C. The disease is responsible for more deaths in The U. S. Than AIDS. In The U.

S, the latest increase in hepatitis C infection is building to the opioid crisis. The Center for Disease Control has voiced the need for comprehensive community programs for opioid prevention that provide a range of testing, treatment and prevention services for hepatitis C and other infectious diseases, including HIV. HCV screening is a significant global opportunity for OraSure. Now unlike HIV, where there's only long term therapeutic care, HCV has a cure. Better yet for global public health, pharmaceutical companies like Gilead have licensed their technology to generic drug manufacturers to permit affordable access to a cure for patients in the developing world.

As countries are able to access affordable treatment, they are examining how to implement screening programs to attack the HCV problem. Our OraQuick HCV product is well positioned to support countrywide HCV elimination programs to screen, diagnose and test and treat and cure HCV as they are developed and funded. These elimination programs are helping governments avoid the costly and significant morbidity and mortality costs associated with chronic hepatitis C and end of life care. Moving on to molecular. We are the first mover and a market leader in developing and launching innovative products that provide reliable, self collection of high quality samples for both genomics and the microbiome to enable research, diagnostic and consumer genomic applications.

Our molecular tools and services address the unmet need for sampling to analysis for molecular applications. Our proven and scalable solutions enable health care workers and researchers alike to collect from donors in any setting, from the clinic to the field to the home. Over the past fourteen years, we've launched a suite of products based on sound science that's guarded by broad and deep intellectual property protection. Some examples of our value and validity include more than 6,000 customers in over 100 countries that use our molecular products and approximately 3,000 peer reviewed publications citing the use of our products. From a revenue perspective, we saw double digit growth in the Human Genomics businesses as well as triple digit growth in the emerging microbiome business in third quarter twenty eighteen as compared to the same period of the prior year.

And there remains a significant opportunity in these markets. Not only are we seeing a growth in personalized genomics offerings, but there's also increased funding and interest in the impact that the microbiome has in individual health and treatment response. As you hear in a moment, we're building on our core strengths in the areas of innovative tools and services to expand even deeper into the multiomics and system biology arena. Multiomics provides a thorough multifactorial examination of health. By examining all the omics, the genome, proteome, transcriptome, epigenome and the microbiome, we can assess all aspects of what is in us, what's on us and what's around us to inform our health.

Multiomics requires the ability to analyze and interpret massive data sets to extrapolate a comprehensive view of health and well-being. Human genome testing has grown rapidly over the past five years alone. It's now used to better understand and characterize thousands of conditions. Since the completion of the Human Genome Project in 02/2003, there's been an explosion in the number of studies and discoveries surrounding genomics and their impact on health. Many of these discoveries are based on large scale genome wide association studies, which encompass thousands of subjects or patients.

In 2011, Orisher acquired DNA Genotec, a Canadian startup company whose flagship product, Aurigene, had revolutionized the DNA sample collection market. Through innovative R and D, DNA Genotec discovered a powerful chemistry that could sustain DNA in saliva for years at room temperature. They marry this chemical platform with an easy to use physical format that enables at home collection and automated processing in the lab, addressing the challenge of large scale sample access that genome wide association studies and large cohort studies require. For the first time, the industry had a mechanism to collect large amounts of high quality DNA through noninvasive sampling. As Time Magazine put it, a little Canadian company is doing for DNA collection what Google did for the web searches.

It made it ridiculously simple and efficient. So let's take a look at the technology. All genomic analysis starts with a collection of DNA samples. Our flagship product, Aurigene, pictured here, is the market leader for stabilizing human DNA for long periods of time at ambient temperature. Aurigene incorporates proprietary physical design and stabilization solution.

Our products are the only FDA five ten clear devices for saliva, DNA collection and stabilization, which is a significant feature that distinguishes us from the competition. And it's noninvasive. That means no finger sticks or needles. The main competition for Orasure remains blood samples, which requires a phlebotomist, cold storage for the sample from collection to the lab. Many people are surprised to learn that the quality of DNA stabilized in Aurigene is comparable to that of blood.

As one of our customers at Cincinnati Children's Hospital said, This is a truly great product. I've tried many different chemistries to obtain DNA. I've not seen a better compromise for yield, purity, time to extract and ease of collection than Aurigene. We are confident that our Aurigene product line has been a key enabler for innovative genomic companies as they scale their businesses. Companies such as 23andMe and Helix are familiar to many and recognized as industry leaders.

And Oprah Oprah is a fan of dog DNA testing sold by one of our customers named Embark. This is she put it on her list of one of her favorite things for 2018. In late twenty seventeen, we signed $143,000,000 contract with one of the world's leading consumer genomics companies. This contract contains minimum annual purchase obligations over several years. As genomic based applications expand globally, our customers outside The U.

S. Are key to our continued revenue growth. Companies like Wuxi Nexcode and Weixin, both from China and Genesis Healthcare from Japan, are examples of current OraSure customers who are thought leaders in the industry. And we still believe we're still in the earliest stages of further market expansion. Markets in China, Japan, South Korea and across Asia are in their infancy, which provides Orsher with even further opportunity to expand our global sales.

We've seen phenomenal growth in our molecular business since we acquired DNA Genotec in 2011. Back then, it was a $12,000,000 revenue business. In 2017, it grew to $75,000,000 That's not bad for a $50,000,000 investment in 2011. Strong revenue growth and an increased number of multiyear supply agreements with key accounts speak favorably for our line of Origin saliva collection products. Now even as saliva testing for human genomics expands rapidly, we're equally excited about the emerging microbiome market.

Microbiome refers to the trillions of bacteria and other microorganisms that live in us or on our body. When we're healthy, we live in harmony with those microorganisms, which have been described as tiny hitchhikers that vary from person to person. These tiny hitchhikers are receiving an increased amount of attention. Research are now exploring the link between human health and the type and quantity of bacteria that's in us and on us. Unlike the human genome, which is stable throughout our life, our microbiome changes frequently.

Researchers are now being funded to explore those changes in the implications for nutrition, disease, therapeutic interventions, lifestyle, and even longevity. In particular, the gut microbiome is being studied to help treat diseases like Crohn's, colitis, and irritable bowel syndrome. Every major research university and medical center is exploring this area. We've leveraged our strength and knowledge in developing saliva collection and stabilization devices for the human genome. We translated this expertise to develop easy to use sample collection and stabilization technology for multiple sample types to snapshot the microbiome.

With products for collecting and stabilizing gut, vaginal and oral microbiome samples, we are now into the design and development stages of an Omnigene device to collect microbiome samples from the skin. These products differ from our saliva based human genome collection devices because they stabilize microbial DNA, not human DNA. Ensuring an accurate snapshot in the microbiome to capture community composition is critical to ensure consistency across samples and time. There are millions of bacteria in each sample, unlike the single species from human DNA. So you can imagine how novel and valuable our technology is for those studying the microbiome.

And because the microbiome changes over time, sampling is not just a one and done proposition. In order to monitor the changes in the microbiome and the impact of treatments, multiple tests are needed over a period of time on the same individual. Omnigene Gut, our device for fecal samples, which is used to characterize the gut microbiome, is resonating in the market. To date, we have more than 700 customers for Omnigene Gut in 54 countries. The product is CE IVD marked for use in the European Union, and the business has grown from $600,000 in 2015 to $3,000,000 in 2017, and revenues through the third quarter of twenty eighteen were more than $4,700,000 The human longevity study of the scientific journal Nature calls Onogene Gut the gold standard for gut microbiome sample collection.

This is high praise, and it validates business strategy which we've already successfully deployed for our saliva based collection devices in the human genome. As interest in the microbiome moves from research to clinical to consumer applications, we expect the addressable microbiome market to be as large as genomics or potentially larger when we consider the use cases for microbiome data are surfacing on a regular basis. This follows the same pattern we witnessed for saliva based human genomics, which evolved from research on the to the rise of 23andMe and Helix and others. Genomics was the first frontier, microbiome the next, and multiomics is the final frontier, or at least until science provides further insights beyond proteomics and metabolomics as our best view of how human health and human body responds to our genes and the environment around us. Broadly speaking, the markets we serve aim to understand the continuum of wellness through disease by profiling well characterized patient populations with molecular techniques.

Genomics has been hugely informative to this end. But when you zoom out, you quickly realize that our 23,000 genes encode only a small fraction of our biochemical potential. Microbes, which colonize us inside and out, collectively encode 10 times more genetic and functional potential. Only recently has the scientific community developed the computational and wet lab tools to harness this relatively new branch of multiomics. The value of combining genomics in the microbiome is clearly evident by the fact that 40% of our microbiome customers were or are customers of our human genomic product line.

And we're well positioned to capitalize on opportunities across multiple sample types and analytes and from the existing Aurigene and Onogene customers as they expand their research and offerings to incorporate more aspects of health through systems biology. This leads me to business development, where we are seeing exciting opportunities for Arshore. We're leveraging our powerful combination of our strong balance sheet, our focused strategy led by David Rapaport, the dedicated business development executive we added to the team in 2018. Simply stated, we expect our business development activities to enhance the company's long term growth and profitability profile, which in turn, we expect to provide attractive returns for our stockholders going forward. This business development strategy is focused on identifying opportunities to license technology or acquire products or companies that complement or leverage our existing business to enhance our end to end service offerings.

And we expect these business development opportunities to advance our goal of being an innovation driven company by adding differentiated products and services in high end growth markets around the world. And to that end, we're delighted to announce last week the acquisition of two companies, Novosanis and CoreBiome, both of which are expected to enhance our molecular business in years to come. Let me share a little color about each one of these acquisitions, which we believe will support our move to a tools, services and diagnostic model. By marrying these deeper tool offerings with end to end services, we can support a multiomics view of systems biology to inform health and wellness. Novosanis is a privately held Belgian company, which was founded in 2013 as a spin off company out of the University of Antwerp.

They are an early stage commercial producer and distributor of urine sample collection devices. Their primary technology, Colli P, is the only available easy to use device suited for the standardization standardized collection of first void urine in the privacy of a user's home or at a clinic. Colli P offers significant competitive advantages to urine testing companies, including superior test performance, ease of use from both the collection and processing and flexible customization options based on specific use case requirements. Its initial commercial application is as a collection device for liquid biopsy tests for the prostate and bladder cancer markets. Novosanis' urine collection technology expands our molecular collection portfolio and advances Orisher's expertise in noninvasive sample collection and stabilization.

COLI P technology serves high growth markets, including liquid biopsy and sexually transmitted infection diagnostics, where OraSure can leverage its existing intellectual property and brand and market expertise to deliver even more value to existing or new molecular customers. CoreBiome is privately held Minnesota based microbiome services provider that spun out of the University of Minnesota. It was co founded in 2016 by domain experts microbiome informatics, genomic methods and clinical lab operations. Their proprietary technology provides fast, information rich characterizations of microbiome diversity and function paired with machine learning and expert analytics. It's an early stage commercial company with customers in the pharmaceutical, agriculture and research communities.

CoraBiome leverages OraSure's leadership position in microbiome sample collection with end to end laboratory services that include sample processing, sequencing and bioinformatics. The acquisition positions Orsher to become a leading end to end solutions provider for researchers, direct to consumer companies and therapeutic and diagnostic development customers all the way from sample to solution. We see powerful synergy from combining DNA Genentech's proprietary sampling and stabilization technology with CoreBiome's platform. We're very excited about this addition to Osher's multiomics story. These acquisitions are the first example of our innovation driven growth strategy taking flight.

They represent clear fits in our strategy to use business development to build upon our solid organic growth trends and enhance our long term growth profile. Both these transactions were completed with modest initial cash outlay, and there's a potential for additional payments based on future performance. We expect that the acquisitions will contribute from 4 to $7,000,000 in net revenue in 2019 and $03 to $05 per share of dilution to non GAAP earnings, excluding transaction costs and required acquisition accounting adjustments. We expect these acquisitions to earn strong returns on invested capital over time. And importantly, these acquisitions represent initial steps in our long term business development strategy.

We look forward to announcing new opportunities in 2019 and beyond. In closing, these are exciting times for Aurisor. The Novosanis and CoreBiome acquisitions are the initial results from our business development strategy. Significant growth opportunity exists in consumer genomics, microbiome and systems biology and eradication programs for HIV and HCV. We will leverage our experience in tools, services and diagnostics.

Our core saliva genomics business remains central to our overall molecular strategy, and we intend to invest and grow in this key business. We're expanding our product portfolio with new that build on our core strengths in genomics and microbiome to move deeper into multiomics and system biology. We're also expanding our core HIV and HCV franchises globally through innovative testing and programs, new registrations, collaborations in our customers and other stakeholders. And beyond HIV in HIV, we intend to leverage our strengths and relationships with existing customers by expanding our portfolio with products, synergistic with our existing ones. We look forward to updating you in the coming months on our progress towards these strategic goals, and I'll let you read the summary later.

Thank you very much.

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