LumiraDx Limited

Good day and thank you for standing by. Welcome to the LumiraDx first quarter 2023 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today. Melissa Garcia, please go ahead.

Hello, everyone. And welcome to today's call to discuss LumiraDx's first quarter 2023 financial results issued earlier today. Joining us are LumiraDx'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 lumiradx.com. Before we begin, I would like to caution listeners that any statements we make today Other than historical facts, our 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, 2022, which was filed with the SEC on May 1st, 2023, 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 LumeriDx.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 first quarter results call. We continue to advance our three priorities, which include commercializing our product portfolio of 12 CE mark tests in Europe and other international markets, progressing our U.S. revenue pipeline and 510K plan, accelerating the development of our high-sensitivity troponin and molecular assays on the platform, and reshaping our organization while lowering our cost base to support strong innovation and commercial success. Milestones reached in Q1 in Europe and other international markets include launching the world's first quantitative finger stick NT Pro BMP test in Q1. This test delivers results in 12 minutes, allowing for immediate linkage to care for patients suffering from heart failure, which afflicts nearly 65 million people worldwide. In February, we showcased this test alongside Medtronic and a number of local healthcare trusts in the UK as part of your Heart Matters bus initiative, delivering free healthcare checks in the community. Since February, we've already shipped our NT-PRO BMP test, the highest margin product in our cardiometabolic portfolio, to more than 100 commercial customers. As previously announced, we achieved NGSP certification in Europe for our HbA1c test, and recently, recertification with the International Federation of Clinical Chemistry, demonstrating the high performance of our assay. Boots Pharmacy announced a new private pilot service for diabetes screening utilizing the Lumary DX platform, and cuts in demand continues to grow across Europe for this assay. We received Japanese PMDA approval for both our HbA1c and CRP tests. These tests are going through commercial readiness implementation, and we currently plan to commence commercial sales in June for Japan. Japan represents an attractive market with high reimbursement and pricing for point-of-care assays. The first quarter marked our highest quarterly sales to date for INR, CRPG, Dyma, HBA1C, and NT-PRO BMP as more European international customers take advantage of our multi-analyte menu. Additionally, we're optimizing the testing locations of our instruments to prepare for a growing shift to non-COVID testing. We're working closely with our customers to achieve this. In the UK, we successfully deployed nearly 800 instruments from the NIH from their COVID procurement into testing locations for non-COVID use cases. We expect to continue to deploy, deploying instruments with the NHS for multi and light testing. And we're exploring a similar redeployment initiative for a portion of our 5,000 plus instrument base in Africa. Overall, we're encouraging our customers to maximize the number of test run per instrument. We've seen our customers continue to diversify the number of different assays they are testing on their instrument, and the volume of non-coating with tests they're doing per instrument. In addition to the instruments redeployed with customers like the NHS, we deployed an additional 350 instruments in the quarter. Along with those, we anticipate deploying over 1,000 instruments in this second quarter. In the US, we concluded our 5-day clinical studies for our 5-minute COVID Ultra product and plan to submit the 5-day notification to the FDA in Q2. Our first 510K for the Lumire DX platform importantly helps pave the way for future 510K submissions for the other tests in our menu, including our cardiometabolic portfolio. Due to low prevalence, we were unable to acquire sufficient clinical samples during the current season to complete our 510K clinical study this year. We continue to work with the independent test assessment program, ITAP, established by the NIH. rapid acceleration of diagnostics program to achieve accelerated FDA EUA review for our COVID and flu combination product for the 23-24 season. This program is in its final stages and currently undergoing external testing. We do see expansion opportunities for the LumiraDx platform in the near term in the U.S. for endemic COVID, seasonal respiratory testing, and for the cardiometrics cardiometabolic menu, which we have commercialized outside the U.S. We continue to see increased orders in the U.S. for the platform even prior to the menu expansion. As a result of our cost reduction program, we're accelerating the development of high-value assays for both molecular testing initially with Strep A and TB and for our high-sensitivity troponin assay. We expect clinical trials to commence in these assays in the second half of the year, for US 510K and IVDR in Europe and expect to launch in the UK and other markets later this year, our high sensitivity troponin test. The advancement of technology and new care models introduced during COVID-19 pandemic have accelerated improvements in the quality, efficiency and convenience of healthcare delivery. Our point of care platform which brings together multiple assays on a single easy to use instrument with a laboratory equivalent performance and a low cost of ownership facilitates this new generation of care and is resonating across our customer base. Customers are now developing increased use cases for deploying our unique point of care technology as seen in the following examples. In the UK, some of the previously mentioned redeployment instruments are being positioned in the NHS virtual ward program. Virtual wards, which are a growing trend in health systems worldwide, allow patients to get care they need in a place they call home, including care homes, safely and conveniently, rather than being in hospital. NHS England definition of a virtual ward is a safe and efficient alternative to bedded care that is enabled by technology. The Lumire DX platform, which delivers a broad menu of lab-comparable primary care tests within minutes, is exactly the type of technology enabling this key development towards a more patient-centric healthcare system. Another example, France is in the process of authorizing legislation to enable an expansion of point-of-care testing and reimbursement into clinical settings that have previously been required to use only lab testing, such as medical houses where general practitioners practice facilities comparable to urgent care clinics and nursing homes. This legislation is expected to open a new large new point of care market opportunity in the second largest country in the European Union. The recent amendment to the U.S. Public Readiness and Emergency Preparedness, or PREP Act, which was enacted during COVID-19, extended PREP Act coverage to essentially allow pharmacists and qualified pharmacy technicians to administer vaccine and COVID-19 testing at pharmacy locations. This model emphasizes the need for point-of-care testing and allows a pharmacist to conveniently test results and treat patients in one visit and is especially impactful in geographic areas and for patient populations lacking convenient access to traditional health settings. The Lumeria X platform that utilizes a single instrument with low cost and high accuracy is particularly well suited to serve the trend to consumer-oriented care at retail locations. And the final example we'll provide is on April 18th of this year, the WHO issued the WHO Standard Universal Access to Rapid Tuberculosis Diagnostics, a plan to achieve universal TB testing for the over 10 million infected with TB annually. As part of the report, the WHO calls for a next generation TB test that will be, quote, Low-cost, battery-operated, rapid nucleic acid amplification test that provides results within 30 minutes at an expected price well below the U.S. $10 threshold and suitable for sample times that are simply to collect, e.g., tongue swabs. This is an exact description of the TB test Lumiere DX is developing and speaks to the enormous global demand for our potential first-in-class product. As you can see, the Lumeria DX platform was designed specifically as a diagnostic solution for the myriad traditional and emerging care models. As our platform continues to mature, our menu expands in key geographies, and our customers continue to implement new workflows enabled by our performance, ease of use, and low cost. We remain confident in our platform's capability to transform community-based healthcare with LabCorp results in minutes. Now, Dorian will further discuss our financial performance in the first quarter. Dorian?