LumiraDx Limited

Good day, and thank you for standing by. Welcome to LUMERA's DX Second Quarter 2023 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'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 that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Melissa Garcia, Vice President, Corporate Council. Please begin.

Hello, everyone, and welcome to today's call to discuss LumiraDX's second quarter 2023 financial results issued earlier today. Joining us are LumiraDX's Chairman and CEO, Ron Swanziger, 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, 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 31, 2022, which was filed with the SEC on May 1, 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 lumiridx.com. I will now turn the call over to Ron Zwanziger for opening remarks and a general business update. We will then provide a financial update before answering questions. Ron?

Thanks, Melissa. Good morning, everyone, and thank you for joining our second quarter results call. In the United States, during Q2, we strategically positioned our North American business to take advantage of the upcoming respiratory season in the short term, while also focusing on expanding our testing menu for both short-term and long-term growth. We have three key updates. First, we extended our testing program with CVS to encompass numerous pharmacies across the U.S., complementing our existing partnership with the CVS Minute Clinics, which has been in place since 2020. The expansion leverages our current installed instrument base, allowing for strong operating margin on testing volumes within these new pharmacy sites during the upcoming respiratory season. Second, our COVID flu combo test has been submitted to the FDA Emergency Use Authorization. The EUA is part of the NIH's independent test assessment program, ITAP, Having already launched successfully in over 25 countries globally, obtaining the UA for our test should be a valuable addition to our US testing portfolio. We're actively engaged in discussions regarding their current status of our application. Third, as reported in a recent press release, we're excited to report our submission of our of a 510K application to the FDA for the clearance of our 5-minute COVID Ultra product. The innovative Ultra test strip design enables higher sample volumes, enhancing detection levels, and reaction times for more precise results. This marks a significant milestone for Lumira DX as we work to expand the markets for our SARS-CoV-2 Ultra test. The receipt of 510K approval from the FDA could also pave the way for expanding our testing menu in the U.S. on the Unifoint. on our unified platform. In Europe, our focus remains on the acceptance and expansions of our non-COVID portfolio, Non-COVID platform test volumes excluding seasonal respiratory products increased 50% sequentially. 26% of our customers purchased more than three assays during the second quarter in 23 versus 17% in the first quarter of 23, highlighting the positive impact of our menu expansion. A specific example of our unique NT-PRO BMP test following the January 23 launch of our NT-PRO BNT-STAT Q2 was dedicated to showcasing its lab comparable performance and user-friendliness to clinicians and key opinion leaders. By offering the only finger-stick NT-PRO BNTs at the point of care, we're able to gain access to key accounts for evaluation. Our efforts have been supported by peer-reviewed studies, including those from the University of Uppsala and the European Journal of Heart Failure, emphasizing the clinical and economic benefits of widespread anti-pro-BMP testing in primary care settings. The studies confirm the excellent performance of our test, the benefits of room-temperature storage, the utility of the same test strip, and method for samples of whole venous blood, capillary blood and plasma, and the short turnaround time of the test, 12 minutes. These published studies are a welcome addition to the body of evidence showcasing our laboratory comparable performance of our tests at the point of care setting. We remain committed to transforming healthcare by enabling early heart failure diagnosis in the community and plan to expand our approach globally. Further, with regards to Entipro BNTP, our collaborative work with Medtronic continues to develop positively. A follow-up event was run in Manchester in July, which continues to show excellent results and a direct impact for individuals being immediately referred for further testing due to elevated results. As a result of our second successful event, we plan to support further events with Medtronic in 23 and have spun this concept out into other mobile settings. one of which is a workplace benefit program being run in Ireland in the fall of 23 with expanded scope. It will not only be hard health checks with our NT-PRO BMP test, but would also support diabetes screening with our HbA1c test, which highlights our multi-menu approach. We plan to further expand on this model globally in an overall effort to broaden general access to such needed health checks in an overall effort to transform how healthcare is delivered within the community. Our CRP test has made significant strides, particularly in community-based settings like virtual wards in the UK. Partnerships like NHS Friendly Health have demonstrated the test value in real-time decision-making for antibiotic treatment, resulting in improved patient safety, experiences, and cost savings. The aim was to support real-time decision-making on the need for antibiotic treatment in frail, acutely unwell patients in an effort to avoid hospital admission, if achievable and desirable, rather than waiting several hours for lab results. This customer described our platform as small, portable, battery-operated, robust, and simple to use with room temperature reagent storage, ideal for community and mobile testing. The clinical and operational benefits were studied across various patients, and the results were very positive. In 50% of patients tested, the Limerida XCRP test improved the safety of care and helped to avoid the need for escalation to hospital care at a cost saving of up to 3,914 pounds per patient. If adopted more broadly, these benefits could lead to substantial savings for healthcare systems. We continue to deliver on our multiple as a menu platform offering as an example. We recently started working with a leading operator of care homes in Austria. They were looking for a more efficient way to test their patients at the bedside instead of sending them to hospitals hospital immediately saving money and reducing patient stress. We're initially starting to work with them in the Vienna region with 15 instruments. They're currently focused on CRP, D-dimer, and our broader respiratory portfolio, and have indicated that in the future, they expand to They may expand to our entire assay portfolio and may also expand geographically into additional regions throughout Austria where they have other customer locations. This is an excellent example of how easy it can be to transform community-based healthcare with the LumeoDx platform when one single portal of instrument can have a major positive clinical impact in nearly any setting. Coming into this year's respiratory season, we believe we're well-placed strategically to continue to grow the CRP business as a broader part of our respiratory portfolio. As the only platform available today at the point of care setting with CRP, as well as flu and COVID tests, we provide a turnkey solution for important clinical pathways that are aimed at curbing antimicrobial resistance by differentiating between viral and bacterial infections. For example, the UK primary care Respiratory Society recommends algorithms they have developed to rule out COVID-19 and flu, taking other symptoms into account and using the point-of-care CRP test if the prescriber feels antibiotics are necessary. Lumira DX has the only platform at the point-of-care setting that can fulfill the entire algorithm with just our one instrument, making both the patient and clinician experience more efficient and desirable to the alternatives. which would require the multiple POC instruments or having to wait hours for laboratory results. On the commercial side, we have expanded our reach to increase sales impact by entering into distribution agreement with Axon Labs, a major player in the industry for Germany and Switzerland, This distributor has already placed an initial order of instruments and assayed them tests and aims to start to roll out in these countries shortly. We also plan to appoint an additional distributor, additional distributors and other regions to increase sales reach and local customer support. The benefits of our broader menu are also felt in Africa. In Africa, we've been working with key stakeholders to drive uptake of non-COVID testing on our 5000 plus instruments installed with the Gates Foundation during the pandemic. We've now started shipping our HbA1c test to various African countries as well as D-dimer test to Zimbabwe. D-dimer has historically been underutilized as a marker of blood clotting in Africa, but the new features of the Ludumira DX platform enable access to this important test. These tests also show utility in high-risk TB and HIV population. This reflects the overall benefit of the platform for tests being deployed in African countries where they have traditionally not been tested in the community. We know that globally traditional healthcare models are being impacted in hospital setting due to funding and staffing restrictions. And as a result, innovations like our portable point of care instruments are needed to allow testing in the community. As we continue to innovate and expand our fortune portfolio, Lumiere DX remains dedicated to transforming healthcare delivery worldwide and contributing to such impactful change. Now, Dorian will further discuss our financial performance in the first quarter, Dorian. Thanks, Ron.