LumiraDx Limited

Good day, and thank you for standing by. Thank you for joining Numeric DX third 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 11 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the call over to Colleen McMullen. Please go ahead.

Hello, everyone. We'd like to welcome you to today's call to discuss Lumiere DX's third quarter 2022 financial results issued earlier today. With us are Lumiere DX's chairman and CEO, Ron Zwanziger, 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 LumiereDX.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 reports, On Form 20F for the year ended December 31st, 2021, which was filed with the SEC on April 13th, 2022, and 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 the course of 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 reconciliation schedule showing the IFRS versus non-IFRS results currently available in our press release issued earlier today which can be found on our website at LumiraDX.com. I'll now turn the call over to Ron Swanziger for opening remarks. We'll then provide financial and business updates before answering questions. Ron?

Thanks, Colleen. Good morning, everyone, and thank you for joining our third quarter 22 results call. As announced this morning, we continue to make progress commercializing new products to drive home growth. At the same time, we've achieved substantial cost savings from restructuring with further scope to exceed our original target. These efforts advance our strategy to transform point-of-care diagnostics while strengthening our financial position. As the overall market for COVID testing has dropped after the surge at the beginning of the year, we are realigned in operations to address customer needs efficiently. We also strengthened our market position through expansion and diversification of our customer base thanks to widely recognized performance and cost advantage over competitors. As we begin manufacturing multiple non-COVID test strips using common materials, we are realizing the benefit of our single highly automated manufacturing process across our menu of assays. Third quarter revenues were about 42 million, mainly with COVID sales. This performance was supported by expansion of our store base and use cases in key markets, including the US. New product launches will contribute significantly to complementing COVID revenues in the next few quarters, which I'll cover shortly. We shipped 900 platform instruments in Q3, primarily to the US, Germany, and Japan. Instrument shipments to Germany and Japan represent opportunities in border, respiratory, and cardiometabolic testing. I want to highlight approximately 5% of test trip volume shipments in third quarter were for non-COVID tests such as INR, CRPD-dimer, and the flu combo. These volumes are enabling customers to evaluate and pilot new use cases for point-of-care diagnostics. Now, sharing our progress and the four key priorities we've created for advancing our strategy to drive financial performance, to shape our organization and cost basis to support strong innovation and commercial success, to commercialize our newly authorized CE marked product portfolio in Europe and other international markets, to progress our revenue pipeline and 5TK plan, and to accelerate the development of our highly sensitive component and molecular assays on the platform. First, we take very seriously the task of strengthening the company's overall financial position, and this is where awareness is resulting in advancements towards that goal in Q3. Cost reduction has been a significant focus, and we have strong results to show from those efforts. We accomplished our initial plans targeting operating expense savings of $16 million per quarter and already implemented further cost reductions to bring this expected savings to approximately $18 million per quarter. We can further reduce our cost basis necessary to ensure sufficient cash resources throughout 2023. As previously discussed, we reshaped the organization and cost basis to focus resources on the strategic priorities I've highlighted. We are exploring strategic partnerships, as we mentioned on the Q2 call, to provide additional avenues for developing and commercializing our platform and look forward to updating you on these opportunities. We continue to deliver on our priority of commercializing new products in Europe and other international markets. We commenced commercial shipments of hemoglobin A1C, a new finger-stick assay for screening and monitoring diabetes that delivers results in under seven minutes. The rollout started with Europe, which is a key market for achieving our platform consolidation strategy at primary care. Our initial test menu is designed to enable customers to consolidate three different instruments they are currently using into a single Lumira DX platform and workflow right now, and the opportunity to consolidate up to six instruments in the next 18 to 24 months. We're scaling manufacturing of hemoglobin A1C and plan to launch additional countries in the next few weeks. Early customers include hospitals, pharmacies, and enterprises that are looking to repurpose the Lumira DX platform for its broader testing capability. We're also on track to launch the NT Pro BMP by the end of this year. Positive initial feedback from key opinion leaders fight the value of diagnosing congestive heart failure in patients at community care settings using NT Pro BMP finger-sting sample that delivers accurate results in 12 minutes. We commence commercial shipments of our new five-minute COVID Ultra test, COVID Ultra pool, and the COVID and flu combination test. Offering a comprehensive respiratory menu on a single platform delivers a critical advantage during this stage of the pandemic, given the need for customers to quickly and easily differentiate COVID from other widely circulating traditional respiratory viruses that are prevalent in the patient population this season. We see significant demand from existing customers in Italy, UK, Germany, and Japan to convert some COVID testing to these new products. In addition, we're seeing growth opportunities from new customers for COVID and flu tests, especially in Japan, with early orders fulfilled for the current respiratory season. We believe this demonstrates the value of innovation in our respiratory portfolio and will aid in retaining and gaining market share and customer adoption. Shifting to the United States, we're addressing the opportunity to progress our U.S. revenue pipeline. In 2022, we more than double our testing size, and I've diversified our customer base for COVID testing across health systems, primary care, pharmacy, and enterprise settings. As previously shared, we're actively working on 510K submissions for both COVID Ultra and COVID plus flu combination tests. We plan to initiate clinical studies during the current respiratory season. We plan to focus the rest of the year, of next year that is, on accelerating and completing these programs and then initiating HbA1c, INR, and strep molecular clinical studies and registration plans in the first half of next year. Next, our commitment is to accelerate the development of high-value assays and the capability to perform molecular tests on our platform. Our first molecular product in development is a TruePointerCare TB test, which delivers results in 20 minutes from an easy to collect tongue swab sample. We're close to finalizing the strip design, having started manufacturing test strips, and are just initiating a pre-clinical study in the field. 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.