Lucira Health, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Lucera Health Fourth Quarter Earnings Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Greg Kotachek from the Gilmartin Group. You may begin.

Thank you, Catherine. Good afternoon, everyone. Earlier today, Lucera Health released financial results for the fourth quarter ended December 31, 2021. A copy of the press release is available on the company's website. Joining me on today's call are Eric Engelson, President and Chief Executive Officer, and Dan George, Chief Financial Officer. Before we begin, I would like to remind you that during this conference call, the company will make forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including without limitation, the risk factor section of the company's annual report on Form 10-K and and quarterly reports on Form 10Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements regarding product development and manufacturing, product potential, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I will now turn the call over to Eric.

Thank you, Greg. Good afternoon, everyone, and thank you for joining us. Welcome to the fourth quarter 2021 earnings conference call. The COVID-19 pandemic has reshaped society's experience with an expectation of healthcare delivery, and Lucera's instrument-free, accurate, easy-to-use molecular test, we believe, offers the performance and patient convenience to play a critical role in what McKinsey and Company recently described as the care at home ecosystem. Lucera Health's mission is to help fuel the growth of test to treat, an important paradigm in reducing suffering from infectious disease. We believe bringing decentralized testing and as a result subsequent treatment to wherever patients may be, the spread of infection can be reduced by limiting the circulation of infectious individuals among the healthy. The ideal location for such testing is in the home. By providing an accurate result within 30 minutes, the Lucera platform enables rapid treatment, and treatment as close as possible to the onset of symptoms has been shown to produce the highest efficacy. Helping to return people to health as easily and quickly as possible is what we are all about. And while COVID-19 testing catalyzed our initial growth, we have broader plans for the test menu that we will bring to market in the coming months and years. This is the power of Lucero's platform, a technology that was years in the making. Revenue in the fourth quarter of 2021 was close to double that of the prior three quarters combined as a result of increased manufacturing output. Manufacturing capacity is continuing to increase in the first quarter of 2022, and we remain on target to reach 1 million units per month during the first half of 2022. Our plan is to continue ramping manufacturing capacity in 2022. Our three main sales channels remain B2B, healthcare, and international, where we have contracted buyers across these channels. Additionally, we also support important online channels such as Amazon, as well as ordering through our websites. Q4 represented our lowest cash burn and net loss in the company's commercial history. We anticipate that 2022 will produce positive adjusted EBITDA. The instrument-free design of the Lucero product is a key differentiator and opens up unique use cases in which there could otherwise be testing bottlenecks or logistics challenges and time delays around an instrument. Multiple members of a household can test simultaneously, as can clinic and hospital emergency department patients during surge times. The convenience for the healthcare system of sending an untethered Lucera test to a patient's home for pre-procedural testing is high due to the instrument-free design that produces rapid results on the spot. The simplicity of operation of the Lucera test means that it is well-suited for individuals who want a quick, easy, and accurate test result without having to come up a learning curve on the more complex user instructions associated with an instrumented test. This also means that in the point-of-care setting, the Lucera test can be run by any member of the staff and not relegated to those with specialized training. With respect to accuracy, molecular tests are unequaled as compared with antigen tests. As the pandemic likely evolves toward an endemic phase, we anticipate that the FDA will eventually call for 510 submissions for testing products. Lucera is well positioned for this shift because our at-home molecular test provides PCR equivalent accuracy. We believe international markets and particularly those in the southern hemisphere, will offset fluctuations, seasonal and otherwise, in the U.S. market as we expand globally. Enterprise customers and hospital systems, like current client Sutter Health, represent a durable use case for Lucero's products, even as COVID shifts from pandemic to endemic. We have been and will continue focusing commercial, and regulatory investments in these business-to-business, healthcare system, and international channels. Our near-term product portfolio includes the development of a combination or multiplex test for flu A, flu B, and COVID-19. Our plan is that with a single swab sample, a user can have results from these three tests all in one device at the same time. We anticipate that running the combo test will be as simple as running our current COVID test. The combo test program is moving forward rapidly, and we anticipate receiving an EUA from the FDA in time to commercialize for the 2022 to 2023 flu season in the Northern Hemisphere. We believe that the benefit of using the combo test early in the onset of symptoms in the convenience of one's home fits the test-to-treat paradigm in which Leucera intends to play a significant role. By testing and having highly accurate results early, quick treatment and quarantine can lead to a reduction in suffering for the infected, as well as contributing to the important public health service of infection control. We believe that this broad control of infection can significantly reduce suffering and productivity losses. The increased availability of accurate molecular home tests and the awareness and use of such by the public is one of the benefits that has arisen from the otherwise treacherous pandemic. Additional tests on our platform are undergoing feasibility evaluations. These include additional respiratory tests and STI tests. We will provide details of the next products to be commercialized. as we report in the coming quarters. We intend to bring a full complement of tests to market and to lead the global expansion of convenient home testing. We are also continuing to add to our digital team with additional deeply experienced hires. We intend to enhance the utility of Lucy, our digital reporting platform. Over time, we expect our digital platform to become an important part of our commercial offering. Lucera's COVID-19 test kits, as a result of their performance, ease of use, and because they are untethered and are uniquely positioned for the test-to-treat paradigm. We are working to build a menu of infectious disease test kits with similar capabilities. This is our focus. COVID has accelerated both Lucera's growth as a commercial enterprise, as well as the market's understanding of and demand for convenient home testing. Our time has arrived, and with each passing quarter, we believe that we are beginning to demonstrate our capability as an organization to manufacture at scale and to play a key role in reducing suffering from infectious disease. Lucera's near-term focus is on generating shareholder value. This through select global commercial expansion, continuing to roll out durable sales contracts, continuing to ramp manufacturing capacity with its associated gross margin improvements, bringing the combo test to market, accelerating the usage of convenient and accurate home testing, and playing a key role in the nascent test-to-tree paradigm. As we expand our product offering and geographic distribution, we believe we will become less reliant upon the fluctuations in demand from COVID testing alone, and we anticipate maturing in our capabilities around business forecast accuracy. Lastly, we would like to recognize employees, partners, and contractors that are working so hard to position Lucera for long-term success. We are more excited than ever about our future and look forward to Lucera's growth in the upcoming quarters. I will now turn the call over to Dan George our CFO, for a detailed discussion of our financials.