Positive Customer Experience Drives Market Adoption and Expands Use Cases for LumiraDx’s Transformative Diagnostic Solutions
London, UK (March 10, 2022), LumiraDx Limited (Nasdaq:LMDX), a next-generation point of care (POC) diagnostics company, today announced financial and operational results for the fourth quarter and full year ended December 31, 2021.
“LumiraDx’s strong 2021 performance marks an inflection point in our strategy for transforming community-based diagnostics,” said Ron Zwanziger, Chairman and CEO of LumiraDx. “The positive experience and validation of the microfluidic technology of our Platform by health systems, emergency rooms, pharmacy chains and other health care providers is expanding market adoption and use cases for fast, high sensitivity, convenient and connected diagnostic test results. Fast Lab Solutions also made a strong contribution to meeting customer needs for COVID testing as we navigate the unpredictability of the coronavirus.The pace of Platform shipments, regulatory clearances and launches, near term pipeline of assays and R&D efforts to expand our test menu for 30+ diagnostic tests for common health conditions gives us confidence in our opportunities for significant non-COVID revenue growth for many years.”
2021 Fourth Quarter and Full Year Financial Highlights
For the twelve months ended December 31, 2021, LumiraDx delivered revenue of $421.4 million compared to $139.2 million for full year 2020. For the fourth quarter of 2021, LumiraDx reported $118.3 million in revenue compared to $112.3 million for the same period in 2020.
Fourth quarter 2021 revenues also rose sequentially compared to strong third quarter 2021 revenues of $109.1 million. SARS-CoV-2 Antigen test strips accounted for $75.0 million in fourth quarter 2021, and we have experienced strong continued demand in early 2022 driven by the impact of the Omicron variant and higher testing rates in all markets. Fast Lab Solutions delivered revenues of $23.7 million in fourth quarter 2021 as adoption of our unique molecular chemistry continued to accelerate as we doubled the number of lab customers from third quarter 2021 to fourth quarter 2021.
Total gross margin for full year 2021 was 36.0% compared to 38.0% in full year 2020. In the fourth quarter of 2021, our test strip margin exceeded 80% while overall fourth quarter 2021 gross margin improved to 46.1% compared to third quarter 2021 gross margin of 35.6%.
Research and development (R&D) costs were $33.8 million in the fourth quarter and $130.2 million for full year 2021. This represents an increase of 22% over the fourth quarter of 2020 and 21% compared to full year 2020 R&D costs as we continued to increase capabilities, opened our new R&D center in Glasgow, Scotland and further resourced our development teams for continued pipeline delivery.
Fourth quarter sales, marketing and administrative expenses were $37.4 million and full year 2021 sales, marketing and administrative expenses were $130.5 million. Reported R&D and sales, marketing and administrative expenses include $5.3 million of amortization and share based payment expenses in the fourth quarter of 2021 and $36.6 million in the full year 2021. In addition, we incurred listing expenses related to our merger and listing of $5.4 million in the fourth quarter and $36.2 million for the full year 2021. Excluding amortization, share based payment expenses and listing related charges, the non-IFRS adjusted operating loss for the fourth quarter was $11.4 million and for the full year 2021 was $72.6 million.
Net loss for the fourth quarter of 2021 was $37.2 million or $0.15 per fully diluted share. The net loss for 2021 was $100.8 million or $0.62 per fully diluted share. Our non-IFRS adjusted net losses for the fourth quarter 2021 and the full year 2021, excluding merger expenses and excluding amortization, share-based payment expenses, unrealized foreign exchange gains and other non-cash financing items were $20.0 million, or $0.08 per fully diluted share, and $111.6 million, or $0.68 per fully diluted share, respectively.
At December 31, 2021, we had $300.0 million in senior debt and $18 million in other term debt. Our cash balance at December 31, 2021 was $132.1 million.
LumiraDx’s senior management team will host a conference call today at 8:00 AM ET to discuss the company’s financial results and business updates. Call in details and a link to view the webcast may be found at https://investors.lumiradx.com/news-and-events/investor-calendar. A replay of the webcast will be available on the Investor's section of the company's website at investors.lumiradx.com shortly after the conclusion of the call. The webcast will be archived for 12 months.
LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has, on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need.
LumiraDx is based in the UK with more than 1,600 employees worldwide.
Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the effectiveness of our strategy, projected revenues and instrument shipments, regulatory approvals, the advancement of our pipeline of tests, customer demand and adoption of the LumiraDx Platform, and the benefits and performance of our tests. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including, among others, general economic, political and business conditions; the effect of COVID-19 on LumiraDx's business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the header "Risk Factors" in the Proxy Statement and Prospectus filed pursuant to Rule 424B(3) with the Securities and Exchange Commission, or SEC, on September 3, 2021 and other filings with the SEC. Although LumiraDx believes that it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain. LumiraDx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Non-IFRS Financial Measures
We present non-IFRS financial measures because we believe that they and other similar measures are widely used by certain investors, securities analysts and other interested parties as supplemental measures of performance and liquidity. We also use these measures internally to establish forecasts, budgets and operational goals to manage and monitor our business, as well as evaluate our underlying historical performance, as we believe that these non-IFRS financial measures depict the true performance of the business by encompassing only relevant and controllable events, enabling us to evaluate and plan more effectively for the future. The non-IFRS financial measures may not be comparable to other similarly titled measures of other companies and have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of our operating results as reported under IFRS as issued by the IASB. Non-IFRS financial measures and margins are not measurements of our performance, financial condition or liquidity under IFRS as issued by the IASB and should not be considered as alternatives to operating loss, gross margin, net income (loss) or earnings per share or any other performance measures, derived in accordance with IFRS as issued by the IASB or any other generally accepted accounting principles.
We define non-IFRS operating loss and non-IFRS net income (loss) as operating loss and net income (loss), respectively, excluding amortization, share-based payments, IFRS 2 listing expense, change in fair value of financial instruments, foreign exchange (gain)/loss, dividends on preferred shares and non-cash interest. We recommend that you review the reconciliation of the non-IFRS measure to the most directly comparable IFRS financial measure provided in the financial statement tables included below, and that you not rely on any single financial measure to evaluate our business.