Original from: yahoo! finance
- Second quarter 2023 revenues of $21.0 million
- Submitted First 510(k) Application to the U.S. Food and Drug Administration (FDA) for 5-minute COVID Ultra test
- Submitted COVID/Flu combo test for FDA Emergency Use Authorization (EUA) as part of the NIH's Independent Test Assessment (ITAP) program
- More than 1,500 new instruments shipped in Q2, primarily to U.S. pharmacy locations to expand testing capacity for the upcoming respiratory season
Ron Zwanziger, Chairman and CEO of LumiraDx, stated, "The submission of our first 510(k) application to the FDA for our COVID Ultra test represents a significant milestone in our ability to deliver on product expansion into the U.S. and could pave the way for additional submissions of other high performing assays on our Platform, many of which are already available in Europe and elsewhere and others which are in late stages of development. In addition, we are seeing revenues from our non-COVID products continue to grow, with the second quarter marking our highest quarter to date for non-COVID revenues. As we continue to innovate and expand our portfolio, we remain dedicated to transforming healthcare delivery worldwide.¡±
2023 Second Quarter Financial Highlights
For the three months ended June 30, 2023, LumiraDx delivered revenue of $21.0 million, compared to $44.7 million for the three months ended June 30, 2022. Non-COVID specific revenues in the second quarter of 2023 were $9.2 million, or 44% of total revenues, including $4.4 million of LumiraDx technology revenues and $4.8 million of distribution revenues.
IFRS gross profit was a loss of $9.9 million for the quarter. Total adjusted gross profit was a loss of $6.6 million.
Research and development expenses were $15.8 million in the second quarter of 2023. Non-IFRS adjusted research and development expenses were $14.3 million in the quarter, compared to $14.8 million in the prior quarter.
Sales, marketing and administrative expenses were $22.7 million in the second quarter of 2023. Non-IFRS adjusted sales, marketing and administrative expenses were $17.6 million in the quarter, compared to $19.0 million in the prior quarter.
The continued reductions in operating expenses reflect the impact of the Company¡¯s restructuring programs.
Net loss for the quarter was $49.7 million, or $0.16 per fully diluted share. The non-IFRS adjusted net loss for the quarter was $50.2 million, or $0.16 per fully diluted share.
At June 30, 2023, the company¡¯s cash balance was $25.3 million.
Recent Developments
On July 20, 2023, we entered into a ninth amendment and waiver to that certain Loan Agreement, dated March 23, 2021 (as amended from time to time, the ¡°Loan Agreement¡±), with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, as lenders, and BioPharma Credit PLC, as collateral agent (the ¡°Ninth Amendment¡±). The Ninth Amendment provides additional term loans in an aggregate amount of up to $31 million (the ¡°New Term Loans¡±). We drew down $15.0 million of the New Term Loans on July 21, 2023 and expect to draw the remaining $16.0 million before the end of August.
We continue to work with various strategic advisors on the previously disclosed strategic review of our business and we are also engaged in discussions with our senior lender about the terms of the Loan Agreement, including the covenants in the Ninth Amendment which are scheduled to be measured on September 1, 2023.
In August 2023, we completed the divestiture of INRstar, a patient reporting and decision support tool, as part of our ongoing efforts to reduce costs and focus available resources on the launch of high value assays.
We are pleased to announce the appointment of Giffin Daughtridge as President, North America Commercial Operations, and Global Molecular Solutions, effective as of August 1, 2023. Peter Scheu, the previous President, North America Commercial Operations, resigned from his role effective August 1, 2023 but continues to support LumiraDx in an advisory capacity.
