Cue Health Inc.

Good day, and thank you for standing by, and welcome to QHealth, Inc., fourth quarter 2021 earnings call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised this call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Caroline Corner, Investor Relations. You may begin.

Thank you, Operator. Welcome to QHealth's fourth quarter 2021 earnings call. Joining me on today's call to discuss our results are Ayub Patak, Chairman and Chief Executive Officer, and John Gallagher, Chief Financial Officer. Our prepared remarks will be followed by a Q&A session. During this call, we'll be making forward-looking statements, including statements related to the expected performance of our business, future financial results and guidance, strategy, long-term growth, and overall future prospects, as well as the impact of the COVID-19 pandemic. We wish to caution you that such statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those we projected or implied during this call. In particular, those described in our risk factors, including in our final prospectus related to our initial public offering dated September 23, 2021, and in our Form 10-K for the fiscal year of 2021 that will be filed following this call. You should not rely on our forward-looking statements as predictions of future events. All forward-looking statements that we make on this call are based on assumptions and beliefs as of the date hereof, and Q disclaims any obligation to update any forward-looking statement except as required by law. Our discussion today will include non-GAAP financial measures. These non-GAAP measures should be considered in addition to and not as a substitute for or in isolation from our GAAP results. Information regarding our non-GAAP financial results, including a reconciliation of our historical GAAP to non-GAAP results, can be found in our earnings release, which was furnished with our Form 8K today with the SEC and may also be found on our investor relations website at investors.qhealth.com. Finally, a recording of this call will be available on our investor relations website shortly after this call has ended. With that, I would like to turn the call over to Ayub for his comments on fourth quarter business highlights. Ayub?

Thank you, Caroline, and thank you, everyone, for joining us today. We've made tremendous progress towards our goal of creating a new way to access the healthcare system, combining accurate diagnostics, virtual care, and soon antiviral delivery, all on a single platform uniting healthcare providers, enterprises, and consumers. I'm happy to report we've achieved significant growth in our installed base, shipping to date nearly a quarter million Q readers. This large increase of our installed base across all of our customer categories, paying sophisticated customers in the traditional healthcare space, such as Johns Hopkins and the University of Pittsburgh Medical Center, to enterprises such as Google, Netflix, and Salesforce, to government agencies and individual households, is reflective of our core platform capabilities, speed, accuracy, and integration with the digital ecosystem. With these core platform capabilities in mind, the growth in our install base is particularly important as Q-Reader is durable and capable of running all future tests in our menu expansion pipeline. Excitingly, we launched our direct-to-consumer offering in Q4 with integrated virtual care, e-commerce capabilities including same-day delivery, and video-based supervised testing, all natively integrated into our accessibility-friendly mobile apps. Today, we have over 220 directly contracted organizations as customers, made up of healthcare provider organizations, governmental bodies, and enterprises, up 2.5 times since the end of Q3. Our $618 million in 2021 revenue during our first year as a public company, up from $23 million in 2020, demonstrated our ability to execute a coordinated strategy across our manufacturing, product, and commercial teams, to bring our vision of the future of healthcare to life. Our mission of delivering more integrated and accessible healthcare is a global one, and we're glad to update that we've begun commercialization internationally in Canada through distributors, enterprises, and a direct-to-consumer offering, as well as in Singapore. In addition to signing many new agreements, we also extended our existing agreements and expanded our relationships with many of our key customers, including Google, the NBA, MLB, and many other major sporting leagues. We also announced a partnership with Albertsons, wherein today Albertsons customers at over 900 locations and communities across the U.S. can get a Q-test administered by their local Albertsons pharmacist. This is an important public health initiative, driving increased access to the lab-quality molecular testing we provide in communities across the U.S., especially for those communities that might not otherwise have access to lab-quality molecular diagnostic tests. Through the quarter, we've purposefully and radically expanded our distribution in the healthcare provider space. I'm pleased to share that we are now distributed by Cardinal Health, McKesson, Medline, and Henry Schein, and we will continue to expand our reach to smaller healthcare provider clinics and other fragmented markets. To the Department of Defense, we shipped 6 million Q COVID-19 test cartridges and 30,000 Q readers over the contract life, demonstrating our ability to scale manufacturing and deliver on large contracts. Through this agreement, our product reached underserved communities in 18 states, thousands of schools, nursing homes, correctional facilities, and community health clinics across the country and the military. Today, we continue our DoD conversations regarding broader opportunities to utilize their installed base. For example, we were recently awarded an IDIQ electronic catalog contract from the Defense Logistics Agency with a value of up to $50 million, which facilitates the acquisition of Q products for any federal agency. Additionally, we're seeing that our strategy of placing an installed base is working for the public sector customer category. Leveraging our public-private relationships and successful deployments, we've converted several end-user public sector organizations and states into direct customers, such as the states of Minnesota, Colorado, and Wyoming, among others. To help us tell Q's unique story of creating and introducing a new product category beyond the traditional healthcare system and into the home, we have been investing in awareness. We had a chief marketing officer, Natin Degol, to our team. He joins us from Abbott, where he led the marketing launch of their continuous glucose monitoring system. We're excited to leverage the Tin's skills and experience with marketing and payers, consumers, and healthcare providers. Eileen Shield joins us as Chief Communications Officer. Previously, she led corporate communications at Cleveland Clinic and Medtronic. We're excited to have Nitin and Eileen join to help bring awareness to the brand, connect to our customers, and tell the story of Qube. They join what has rapidly become a world-class leadership team here at Qube. The best-known sports leagues, such as MLB, NBA, NHL, and many NCAA teams utilize Q, and in this new category of molecular testing anywhere, anytime, we're finding innovative ways of marketing and bringing to life our vision of the future. It is such a unique time where diagnostics has entered the cultural consciousness and behavior and expectations of how the healthcare system should work have evolved dramatically because of COVID. We've partnered with some of the biggest athletes and stars to help bring our product and brand story to life in the minds of our customers, from NBA All-Star players Carl Anthony Towns to Super Bowl champ Aaron Donald and actress Gal Gadot, all avid Q users. Now you may have caught our Super Bowl ad, which was seen by 107 million viewers and drove a 10,000 times increase in our traffic to our website after it aired. Our number one goal with our Super Bowl ad was to increase awareness of our brand and establish Q as a digitally connected smart health lab platform that will serve consumers beyond COVID. As we have created this new category of molecular testing spanning the home and the traditional healthcare system, we've had to rapidly scale our manufacturing. Last year, we increased our production capacity to nearly 100,000 test cartridges per day, measured over a seven-day period, as part of completing our DoD agreement. This represented nearly a 50-time scale-up of a novel molecular testing product in the course of one year, fully integrated, highly automated, and domestic. This is the result of a decade of investment in product design, automated manufacturing, and excellent execution by our operations team. The strength and ownership of our manufacturing capabilities provides us with a core competitive advantage going forward for quality, cost, and supply capability. All of these investments we have made in scaling our manufacturing, from biochemistry production to cartridge manufacturing, will serve our test menu expansion with no modification required. This shortens the path from R&D to at-scale commercialization for our future test menu. So let's talk a little more about one of our key growth drivers, menu expansion. Menu expansion is critical to our future because each test will significantly expand our addressable market, but more importantly, allow Q to become ubiquitous as a natural choice to turn to at the first sign of respiratory symptoms or for sexual health concerns. As consumer behavior has evolved to expect immediate answers for health issues, just as we experience with other parts of our life, from food delivery to transportation, we believe this paradigm has shifted in consumers' minds for testing for infectious diseases, similar to how glucose meters and pregnancy tests have changed the paradigms for their markets. Our pipeline and development includes tests in the respiratory, sexual health, women's and men's health, cardiometabolic, and wellness categories, all of which will run on the Q-Reader. The Q-Reader is the basis of our install base, and which we have shipped nearly a quarter million units of. Our R&D team is making exciting progress, executing well against our near-term milestones for venue expansion. Starting with our goal of COVID-510K clearance, we completed clinical enrollment in February ahead of schedule and expect to submit our COVID product to the FDA for de novo review in Q2 for 510K clearance. For our flu A-B test, we began enrolling patients at our clinical study sites in December as planned. We expect to continue enrolling patients in the study through Q2, with the expectation to submit for FDA de novo review in Q3. Flu season has been light this year, so we anticipate including bank samples as part of our FDA submission. Notably, funding for both the COVID and flu clinical studies is provided by BARDA, Biomedical Advanced Research and Development Authority, a division of HHS and a long-term partner of Q2. For our flu AB plus COVID multiplex test, we are in late-stage technical development and can detect and differentiate between flu AB versus COVID. We will continue to optimize this assay's performance. We expect clinical studies to begin in the second half of 22. This multiplex test does have an EUA pathway that could simplify the clinical and regulatory process versus a standard 510K. For our RSV test, we are progressing on late-stage technical development and expect to be in clinical studies in Q3. Last year's RSV peak was during the summer. Within our sexual health category, our chlamydia and gonorrhea multiplex test is progressing well. The chlamydia and gonorrhea multiplex test is in late-stage technical development, and we expect to commence clinical studies for this test in the second half of 2022. We currently have a COVID-19 Omicron-specific test cartridge under review with the FDA. At the request of BARDA, we were able to complete primer design, assay development, and updates to the QHealth app, and all required studies in a nine-week period. We submitted for emergency use authorization on March 3rd, so we look forward to updating you on progress on that test in the near future. All in all, menu expansion is proceeding at a very fast clip, and we have a robust set of tests showing strong progress that will increase our addressable opportunity. Combined with significant upgrades made and are making to our digital capabilities, which all of our diagnostics results flow seamlessly through, we think we're in pole position to enable a new experience of the healthcare system across many of the most common reasons individuals use the healthcare system. I'll expand further on our digital capabilities growth, a key growth driver. because these capabilities enhance the value and actionability of our diagnostic results. We're investing heavily in and rapidly building the technology enhancements for our integrated care platform. Our software development team has recently been focused on building out the integrations with leading electronic medical record systems, expanding internationally to ex-US app stores, and building the next generation of digital capabilities for Q, including streamlined test-to-treat workflows that include prescription delivery. We believe our planned future enhancements will provide an even more comprehensive and seamless digital health experience, including efforts we are making to enable reimbursement directly on our platform. Right now on queue, you can take a molecular diagnostic test for COVID-19, share your results securely with a physician and visit with them, and they can write a prescription all without leaving the app. We are getting very close to having our eureka moment of linking diagnostic results with virtual care, and the final piece, antiviral and prescription delivery. Our solution for COVID-19 is a major proof point, as this diagnosis, virtual care, prescription delivery format is the heart of our vision for Healthcare 2.0 and will apply to other respiratory products, sexual health infections, and even for managing chronic diseases. Wouldn't it be great if when your kid has a sore throat, you could just reach for a run an accurate molecular test, and detect strep, talk to a doctor, and have an antibiotic delivered? In summary, with continued expansion of our customer base, test offerings, and software and services, our team is making great strides towards our mission of making healthcare more timely and accessible. As we continue to build out the business, we are excited by what we have in store for the near-term future and I look forward to updating you on our progress on future calls. With that, I'll turn it over to John to walk through our financial results.