Lucira Health, Inc.

Good day, and thank you for standing by. Welcome to the Lucira Health's first quarter earnings conference call. At this time, all participants are in 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 will need to press star 1 on your telephone, and please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand over the conference to your speaker for today, Mr. Greg Hudacek. Please go ahead, sir. You may begin.

Thank you, Delphin, and good afternoon, everyone. Earlier today, Lucira Health released financial results for the first quarter ended March 31, 2021. A copy of the press release is available on the company's website. Joining me today, On today's call are Eric Engelson, President and Chief Executive Officer, and Dan George, Chief Financial Officer. Before we begin, I'd 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 factors section of the company's annual report on Form 10-K and quarterly reports on Form 10-Q. 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, product potential, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I now will turn the call over to Eric.

Thank you, Greg. Good afternoon, everyone, and thank you for joining us. Welcome to the first quarter 2021 earnings conference call, our first as a public company. We will start today's call with an overview of Lucera and the accomplishments that made the company what it is today. I will then discuss our company strategy and how its implementation has led to significant progress this quarter, followed by a discussion of our future opportunities. Dan will then transition into a more detailed walkthrough of our first quarter financial results. Since our inception in 2013, Lucera has been developing our technology and paving the way towards revolutionizing at-home testing for infectious disease. The founding vision was to put lab-quality molecular testing in a small, easy-to-use form factor that would fit in the palm of the hand for use anytime, anywhere, and that would produce results on the spot. We have always believed that if testing were available, accurate and easy to use, individuals would proactively test, enabling earlier treatment or quarantine should the test result positive. or faster peace of mind should it result negative. Ultimately, we believed that this would serve the public health. Just as point-of-care testing was an important innovation that augmented central lab testing, we believe that anywhere, anytime testing with high consumer usability under an over-the-counter label represents an important next advance provided that test accuracy is maintained. As testing demand increased during the first wave of COVID infections last year in the United States, we all witnessed the logistics issues that were caused by the immobility of the testing equipment. This resulted in traffic jams at testing centers and the risky circulation of potentially infectious individuals within the general population. Although home sample collection kits helped to alleviate some of the challenges, the long wait time to results remain an issue. It was during this time that we shifted our focus from our initial plan to bring an influenza test to market to prioritizing the COVID-19 test kit first. Our company launched our flagship product, the COVID-19 All-in-One Test Kit, on November 17, 2020, upon FDA EUA authorization for both point of care and prescription at home use. This was the first and remains the only prescription at home EUA granted. The accuracy of our test was demonstrated in our community testing study, which at the time included symptomatic individuals. This was subsequently expanded to also include asymptomatic individuals in the study that supported the recent over-the-counter EUA. When compared head to head against high sensitivity PCR central lab tests, excluding samples with very low levels of virus that possibly no longer reflected active infection, our test kit achieved 98% accuracy, 97% PPA, and 98% NPA. As we entered 2021, our company had a near-term strategy that supported our broad vision of supplying accurate, accessible, timely testing. Our goals were one, submission of an over-the-counter EUA and expansion of current point of care and prescription at home EUA to also include asymptomatic individuals. Two, commercialization of our test kits through various sales channels and formation of strategic partnerships. Three, expansion of manufacturing capacity. Four, creation, of an easy-to-use platform to report test results, and five, continued development of the test menu. Following initial commercialization of our COVID-19 prescription at home test kit, we focused efforts on making our test kit more accessible through OTC labeling. To that end, we submitted an application to FDA for an over-the-counter EUA. We also submitted an application to expand the initial prescription EUA to include asymptomatic individuals. In April of 2021, we received the over-the-counter EUA for the company's Lucera CheckIt test kit. With the release of this test kit, we addressed the need in the market for a PCR quality, affordable, accurate, over-the-counter test. Lucera Check-It is now available to individuals without requiring a physician prescription or healthcare professional oversight, allowing users to detect a positive result in as few as 11 minutes or to confirm a negative result within 30 minutes. And on April 26, we also announced that Health Canada issued an authorization with conditions for our Lucera Check-It COVID-19 test kit. Those conditions were to submit final bilingual labeling, which we expect to complete shortly. To drive commercialization and increase accessibility, we have formed key strategic partnerships. We have partnered with Converge Technology Solutions to develop an efficient way to deliver results to the user with the Text Lucy system. Lucera developed the Lucy Pass to provide users an easy way to receive a digital verified test result. Customers simply text the word Lucy, L-U-C-I, to 44544 and then follow the simple steps to upload their results. All test results are digitally verified through Lucy's secure portal. Once users have a Lucy Pass on their phone, they can show their negative test result at entrances to conferences, workplaces, arenas, and for travel and leisure. With an easy way to access results in place, we have begun forming direct partnerships with organizations that plan to use the Lucera Check-It Test Kit on a large scale. For example, we recently launched a testing program with the Golden State Warriors to facilitate the safe reopening of the Chase Center in San Francisco. Most recently, we have commenced an agreement with Amazon for the sale of our OTC Lucera Check-It Test Kit online, significantly increasing our opportunities to reach our customers nationwide. Amazon not only provides an easily accessible marketplace, but offers proven distribution channels, allowing our product to be in your hands more quickly. We see programs and partnerships such as these as being a key driver of sales in the upcoming quarters. We see programs and partnerships such as these being an important contributor to future sales growth. Given the uncertainties surrounding the current COVID-19 environment, we have prioritized flexibility and nimbleness to match the expanding and evolving testing landscape. We continue to evolve our products to fit current needs. As noted in our technical brief posted on our website, we perform routine surveillance of emerging SARS-CoV-2 strains by periodically evaluating in silico reactivity against sequence databases. These evaluations have shown that the six emerging variants are reactive to our COVID-19 test kit. Looking to the future, the company has created a clear path to growth that includes, one, continued commercialization of our COVID-19 test kit for both OTC and prescription use. Two, formation of new programs and partnerships with sports teams, large venues, travel and leisure, distributors, and other entities. Three, investing in manufacturing capacity and scaling to match demand. Four, international opportunities. And five, test menu expansion. We are excited about our future and look forward to the upcoming quarters. I will now turn the call over to Dan George, our CFO, for a detailed discussion of our financials. Thanks, Eric, and hello, everyone.