LumiraDx Limited

Good day and welcome to the LumiraDX second quarter 2022 earnings 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. As a reminder, this call may be recorded. I would now like to turn the call over to Colleen McMillan, VP Communications. You may begin.

Hello, everyone. We'd like to welcome you to today's call to discuss LumiraDX's second quarter 2022 financial results. issued earlier today. With us are Lumiere DX's Chairman and CEO, Ron Zwanziger, Chief Financial Officer, Dorian LeBlanc, and Chief Product Officer, Pusha Patak. 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 risk 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, and 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. 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, Colleen. We continue to deliver on our mission and promise to transform community-based care. Looking ahead as part of the transformation, the company has four key priorities in the next 12 to 18 months, and I'd like to provide updates on each of these areas. Our first priority is to commercialize our newly authorized CE product portfolio in Europe and other international markets. The second, we're progressing our U.S. revenue pipeline and 5TK plan. The third, we're accelerating development of our highly sensitivity troponin and molecular assays onto the platform. And fourth, we're shaping our organization and cost base to support strong innovation and commercial success. We've made tremendous progress on our first priority to deliver on our pipeline plan and commercialize new products in Europe. On the point of care platform, we achieved five new CE marks including hemoglobin A1C, anti-pro-VMP, pro-congestive heart failure, COVID ULTRA, a five-minute version of our COVID antigen test, the ULTRA pool test, as well as the RSV combo with COVID. Each of these tests deliver lab-comparable performance in minutes on the Lumira DX platform. We also expanded the use of CRP to the added populations and added an exclusion claim to our D-timer test. Our focus now is to commercialize these products in Europe and also to register in key international markets HPA1C COVID Ultra pool test as well as the COVID RSV Combo test are planned to launch commercially in Q3. NT-PRO BMP test will launch by the end of the year. We have compelling value proposition and are seeing early demand for these new products, which have been designed to enable our customers to consolidate three different instruments they are currently using into a single Lumira DX platform. and workflow right now, and with the opportunity to consolidate up to six instruments in the next 18 to 24 months. In the fast lab solutions, we achieved CE mark for two RNA star complete assays. The flu and COVID combination assay, as well as the dual target COVID assay, provide results in 20 minutes using open channel RT-PCR lab systems. We're seeing the demand for these assays, which combines speed, throughput, and performance for molecular. Shifting to the United States, our second priority is to progress our U.S. revenue and pipeline. We continue to solidify the unique performance and positioning of our high-sensitivity antigen test on the platform. In the last year, several of our large customers have expanded the use of our platform to new locations originally designated for point-of-care molecular testing or central lab molecular testing, with a number of others now making a similar change. This is based on our data showing molecular-like performance with substantial cost savings and reflects the power inherent in the performance of our platform. We plan to submit a new UA for the COVID antigen ultra test on the platform shortly and are actively working on 510K submission. COVID ultra followed by flu, AB ultra, RSV ultra, and strep A molecular are planned to go through clinical studies during the upcoming respiratory seasons. This respiratory portfolio combines molecular-like performance with speed at point of care. With hemoglobin A1C product being commercialized in Europe, we plan to initiate U.S. clinical studies later this year and also for INR. This core product offering will enable us to consolidate much of the current point of care primary care offerings in the U.S. onto a single platform. Our third priority is to accelerate the development of our troponin and molecular assays on the platform. During our recent Analyst Day, we were able to share the results from a method comparison study demonstrating that our high sensitivity troponin assay test correlates very well with the market leading high sensitivity central lab assay. We currently are reviewing our global clinical study plan with key opinion leaders, after which we will be in a position to initiate prospective studies. Our molecular pipeline continues to progress well with two leading programs planned to complete development this year. Both Strep A and TB programs leverage our QSTAR technology, validating the performance and speed that can be achieved with a proprietary chemistry. Our Strep A and TB product design is being finalized, and our plan is to start clinical studies late this year or early next year. We recently received an additional investment from the Bill and Melinda Gates Foundation, which included funding from a commercialization of a number of our tests, including TB. We have four to five additional projects in various stages of research and development. All this leads to our fourth priority, building the company's overall financial position. We have an exciting set of product launches in the near term that will start to generate revenue later this year and expect rapid acceleration next year. At the same time as COVID moves from pandemic to the endemic stage, we have a lower but also more stable revenue place to plan with. To allow for sufficient runways to achieve pivotal milestones, we completed 100 million-plus million in financing last month and initiated a restructuring program focused on three main areas. The reduction of manufacturing as a direct consequence of lower COVID demand, deprioritizing of a few R&D programs, and a few early-stage assets. And finally, reorganization of our R&D delivery organizations. We're confident these actions will bridge us towards a key revenue milestones while delivering on our mission for improved health outcomes at lower costs 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?