Lucira Health, Inc.

today and thank you for standing by. Welcome to the Lucira Health Second 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 if you require any further assistance, please press star 0. I would now like to hand the conference over to your first Our next speaker today, Hannah Jeffery from Gilmartin Group. Please go ahead.

Hannah Jeffery Thank you, Lori, and good afternoon, everyone. Earlier today, Lucira Health released financial results for the second quarter ended June 30, 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'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 in 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 include, without limitation, statements regarding product development, product potential, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I'll now turn the call over to Eric.

Thank you, Hannah. Good afternoon, everyone, and thank you for joining us. Welcome to the second quarter 2021 earnings conference call. I would like to start by saying that we are excited about the substantial progress we have made during the second quarter of 2021. Lucera has capitalized on the solid foundation built since our inception and we look forward to continued success. During today's call, we will recap the progress and accomplishments of the second quarter of 2021, discuss our ongoing strategy, and talk about the future. Dan will then transition into a more detailed walkthrough of our second quarter financial results. Lucero was founded on the mission of revolutionizing at-home testing for infectious disease by putting lab-quality molecular testing in a small, easy-to-use form factor for use anytime, anywhere that would produce PCR-like quality results on the spot. Our strategy has always been motivated by our belief that earlier treatment or quarantine would greatly aid in the fight against any infectious outbreak. Shifting the current climate of testing begins with creating an accurate, easy to use, and readily available test. We believe our platform checks all of the necessary boxes and will become a testing platform of choice for many different infectious diseases. During the past year and a half, we have seen a real-time shift in the testing market and an increased need for decentralized testing. The unfortunate arrival of COVID helped to abbreviate the typical time required to launch a decentralized testing platform. Our COVID-19 all-in-one test kit was developed to help alleviate many of the burdens and logistical issues associated with centralized testing and to provide patients with an accurate and convenient testing alternative. With COVID acting as the catalyst, we are excited to continue to advance the Lucera decentralized testing platform. I would like to provide a financial summary before turning to a more detailed review of the second quarter. Following the first quarter's commercial debut, Lucera produced record results in the second quarter of 2021. During the second quarter, we recorded revenue of $12.4 million, representing a 175% sequential growth from the previous quarter of 2021. In addition, our gross margin is continuing to improve sequentially as volume increases. Although we anticipate that Lucera could be at a gross margin positive run rate by year-end 2021, Our focus is less on gross margin in the near term in favor of continued investment in production capability optimization during the second half of 2021. Our quarterly revenue was a direct culmination of contributions from several key initiatives that we have been focused on throughout the first half of 2021. These initiatives are rooted in the following areas. One, opportunities generated by the OTC indication. two, opportunities from international demand, and three, worldwide reopening versus control of COVID and new variants. During the second quarter, a leading driver of revenue for Lucera resulted from the FDA issuing an EUA authorizing our OTC use of the Lucera CheckIt test kit. Lucera CheckIt, which allows users to detect a positive result in as few as 11 minutes, or to confirm a negative result within 30 minutes, is available to individuals without requiring a physician prescription or healthcare professional oversight. In addition, the OTC EUA authorization has opened up many distribution channels and partnerships for Lucera. Regarding commercialization, we are focused on targeting large businesses and have initiated several partnerships during the quarter. These partnerships reflect large orders of our test kits and for their duration can provide steady recurring revenue. As discussed last quarter, an example is our partnership with the Chase Center in supporting their reopening. We were the sole supplier of tests as the Chase Center reopened to fans. Additional examples of commercial partnerships include Minta, which customized a workflow for the Lucera all-in-one test kit and was utilized by athletes and individuals traveling to Japan in the summer of 2021, and more recently, Ezova, which negotiated authorization to sell the Lucera Check-It test kit with Ezova's video observation services for travel to Hawaii. We are continuing to partner with businesses and distributors and believe Lucera can become a leader in decentralized testing. Another key area of demand for us this quarter was from international customers and distributors. With the rise of new COVID variants and much of the world still experiencing low vaccination rates, Lucera is working to support partnerships and corporate customers, both domestic and international. We had an international interest in the latter half of Q2, and we predict that this trend will continue and expect to see increased international sales in the second half of 2021. We plan to provide a regional breakdown once an established ordering cadence is achieved. Also in the quarter, the Lucera Check-It Test Kit was available for online purchase through Amazon.com, creating a nationwide distribution channel for Lucera. Late in the second quarter, we made the decision to temporarily halt sales through Amazon and our website as we prioritize distribution to our partnerships. We intend to reactivate online ordering again in the second half of 2021. As the world begins to balance reopening with the emergence of new variants, Lucera aims to remain at the forefront of decentralized testing. We are noticing that the market is evolving. Quality and reliability are more of a focus, and the Lucera Check-It is designed to optimize these factors in a convenient form factor that provides results on the spot. Given the current environment, it will be essential to continue forging relationships and partnerships domestic and international. We believe COVID will be endemic and will require testing for years to come, and in the immediate future, testing will be heavily relied upon as the world begins to return safely to normal. Regarding new COVID variants, we perform routine surveillance of emerging variants, including the Delta variant and others, by regularly evaluating reactivity against published sequence databases. Based upon these evaluations, current variants that have been highlighted by the CDC and the WHO are detected by our test. In addition, our technology enables test reactivity to new variants without sacrificing accuracy. In addition to the accuracy of the Lucera test, the companion Lucy Pass text-based reporting system aids reopening efforts. The Lucy Pass provides users an easy way to receive a digitally verified test result and to access this result for up to seven days on a smartphone. As events, venues, workplaces, and travel continue to require proof of a negative test, LucyPass provides users with flexibility and convenience. In fact, it could be more time efficient and safer to test and result in the comfort of one's home, hotel room, or car, and then to show a LucyPass as evidence of a negative molecular test result than to mingle among others of indeterminate COVID-19 status during group testing. To support the sales ramp, we have focused efforts on expanding manufacturing capabilities. During the second quarter of 2021, we announced that the opening of a new manufacturing center in the Dominican Republic with our manufacturing partner, Jabil. This new manufacturing facility has the potential to manufacture about 1 million units per month at full capacity. Lucera products is currently being produced at this facility. We are excited about the progress that has been made after only two quarters of commercialization and anticipate that this facility will be operating at full capacity in the first half of 2022. Investment in supply chain has been made to mitigate potential disruptions, resulting in more than approximately $36 million of inventory on our balance sheet. In addition, although confident in our ability to procure materials used in the manufacturing processes, We are aware of industry-wide shortages that could result in certain materials being thinly supplied, and as a result, we are keeping a close eye on this. We, of course, have work to do, but are gratified to see customers, governments, and businesses recognize our product's unique attributes. We will continue to optimize the supply chain and manufacturing in order to meet global demand. In support of the manufacturing expansion and top-line growth, We continue to add to our executive team and are pleased by the level of talent that we have been able to attract both to this team as well as throughout the company. In May of 2021, we hired a chief revenue officer, Kevin Collins, who brings experience as a global commercial business leader. Kevin, in turn, hired a handful of seasoned healthcare professionals with commercial experience and their efforts immediately yielded additional partnerships in healthcare professional, distribution, and government channels. The investment in our sales organization is paying off, and the demand from the business and global government community is building. We continue to add experienced talent to the management team and throughout the organization commensurate with growth. Looking to the future, Our focus is to build upon the momentum established in the first half of 2021. We believe there is a significant growth opportunity with our COVID-19 test kit. Based on recent changes that many member states of the European Commission made in their policies, we made the strategic decision to forego applying for temporary allowance of our Lucira Check-It test kit in countries that fall under the EC. Instead, we plan to submit our application through the standard CE certification process in the first half of 2022 for the Lucera Check-It Test Kit. In June 2021, we decided to withdraw our last pending EUA application that was intended to expand the current prescription EUA to also include suspected asymptomatic individuals. we decided it was more valuable to focus our efforts on a 510K, which we plan to submit to the FDA in the second half of 2021. We do not expect this withdrawal of this last pending EUA to have a revenue impact. In addition, we are increasing investment in assays and products for the detection of sexually transmitted infections and other respiratory infections, and we have fully resourced the development of the multiplexed COVID-19 flu product. The market demand for the COVID-19 test kit has underscored to us the utility of the Lucera technology, and we intend to capitalize upon the potential of this technology across many products. While additional product launches will take time, we are redoubling investments to speed parallel development processes. 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.