LumiraDx Limited

Good day and thank you for standing by. Welcome to the Limerick 4th Quarter 2022 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 1-1 on your telephone. You will then hear an automated message stating that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Melissa Garcia. Please go ahead.

Hello, everyone. We'd like to welcome you to today's call to discuss LumiraDX's fourth quarter and 2022 full-year financial results issued earlier today. With us are LumiraDX's Chairman and CEO, Ron Zwanziger, Deputy CEO, Veronique Amey, and Chief Financial Officer, Dorian LeBlanc. The press release announcing our financial results is posted on the investor relations section of the company's website at lumiridx.com. Before we begin, I would like to caution listeners that any statements we make today, other than historical facts, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Please be aware that all such forward-looking statements involve risks and uncertainties, such as those detailed in our annual report on Form 20F for the year ended December 31st, 2021, which was filed with the SEC on April 13th, 2022, in our report on Form 6K that was filed with the SEC on August 16th, 2022, and in other filings that we make with the SEC. Any forward-looking statements that we make must be considered in light of these factors. Actual results may vary materially. Also, during today's call, we may refer to certain non-IFRS financial measures. Non-IFRS financial measures should not be considered in isolation from or as a substitute for financial information presented in compliance with IFRS. There is a schedule showing the reconciliation of these non-IFRS financial measures in our press release issued earlier today, which can be found on our website at lumaridx.com. I will now turn the call over to Ron Zwanziger for opening remarks. We will then provide financial and business updates before answering questions. Ron?

Thanks, Melissa. Good morning, everyone, and thank you for joining our fourth quarter results call. As announced this morning, we continue to make progress, commercializing new products to drive near-term growth, as well as progressing our pipeline to deliver our high-value products. These efforts advance Lumira DX's strategy, transform point-of-care diagnostics while strengthening our financial position. As planned, we continue to adapt and shift the business in response to changing COVID market dynamics, leveraging new product innovation and introduction of combinations to retain and grow market share. At the same time, we are working actively with customers to redeploy instruments to support broader community-based testing. We continue to remain focused on expanding and diversifying our customer base thanks to widely recognized performance and cost advantages over competitors. As we begin manufacturing multiple non-COVID test strips using common materials, we're realizing the benefit of our single, highly automated manufacturing process across our menu of assays. Fourth quarter results were approximately 41 million, mainly from COVID sales. This performance was achieved with higher volume but lower average selling price based on market mix compared to the third quarter. We shipped approximately 1,500 platforms during the quarter, primarily in Europe. Next, I would like to share progress against the key priorities we have communicated for advancing our strategy and driving financial performance. Our key priorities are to commercialize a newly authorized C product portfolio in Europe and other international markets, to progress our U.S. revenue pipeline and 510K plan, to accelerate the development of high sensitivity to troponin molecular assays on the platform, and to shape our organization and cost base to support strong innovation and commercial success. First, we continue to deliver on our priority of commercializing new products in Europe and other international markets. We commence commercial shipments of our NT-PRO BMP tests in Europe into key accounts. This is the first of its kind product, delivering quantitative results from a finger-stick sample in 12 minutes and designed to allow immediate detection and referral of heart failure in primary care. Initial key opinion leader and customer feedback for this test has been very positive. The HBA1C rollout, which began in Q3, is progressing well, and together with CRP, has catalyzed our instrument consolidation strategy. As a reminder, our current test menu is designed to enable customers to consolidate three different instruments they are currently using into a single Lumiere DX platform and workflow right now, with the opportunity to consolidate up to six instruments in the next 18 to 24 months. Earlier this month, we also achieved NGSB certification in Europe for our HbA1c test, which now opens up many more tender opportunities in key European markets. Finally, Europe is not a huge respiratory market. However, innovation in the overall respiratory portfolio, such as COVID flu, COVID RSV combos together, with differentiated products such as COVID pooling and COVID Ultra 5 minutes have enabled us to defend our market share and serve COVID customers in the region. Shifting to the United States, we're growing our U.S. revenue and pipeline and remain focused in the near term on respiratory tests. We're actively working on a 510K submissions for both COVID Ultra and COVID flu combination tests. We initiated clinical studies earlier this year and plan to submit our 510K applications for the COVID Ultra in Q2. This enables us to continue sales after the public health emergency ends. We're still on track to complete the HbA1c and ISDAR clinical studies this year. With the respiratory system ending, acquiring sufficient clinical samples to complete COVID and flu 510K requirements may be at risk. However, we are working with the Independent Test Assessment Program, ITAP, the ITAP established by the National Institute of Health Rapid Acceleration Program, the RADx, tech program to achieve accelerated FDA EUA review for our COVID and flu combination product. Next, our commitment to accelerate the development of high-value assays and the capability to perform both antigen and molecular tests on our platform. We've made progress on two key programs since the start of Q4. troponin and strep A molecular. In preclinical studies, our strep molecular A test is demonstrating high sensitivity equivalent to the leading point of care molecular tests in the market. We anticipate starting clinical studies during the 23-24 respiratory season with an IVDR submission in Europe and 510K submission in the United States in the first half of next year. We have a strong molecular pipeline following this product, including COVID, TB, flu A, B, and chlamydia and gonorrhea, where we have already demonstrated feasibility of the chemistry developed from our fast lab technology. We have made good progress with our troponin test since our last update. In preclinical studies, the test has high sensitivity, equivalent to laboratory analyzers within 12-minute test time from finger-stick blood and venous blood and plasma samples. We expect to commit initial clinical studies in the fall with an IVDR submission in Europe and a 510K submission by mid next year and faster access to select strategic markets such as the UK. We continue to be excited about both programs which are of high interest to our customers. In summary, we continue to progress on our strategic milestones, enabling us to deliver our mission for improved health Outcomes at lower cost through fast, accurate, and comprehensive diagnostic information at the point of need. I'll now hand things over to Dorian to go deeper into our financial performance. Dorian?