Original from: businesswire

Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the second quarter 2023.

Recent Highlights

-    Reported second quarter total revenue of $10 million at the top-end of our guidance.

-    Received landmark first, over-the-counter De Novo authorization from the FDA for the Cue COVID-19 Molecular Test.

-    Awarded a new $28.3 million contract from BARDA, the U.S. Biomedical Advanced Research and Development Authority, to accelerate the development, validation, and regulatory authorization of a Flu A/B + RSV + COVID-19 molecular multiplex test for both at-home and point-of-care setting.

-    Submitted the Cue RSV Molecular Test as a De Novo submission to the FDA for at-home and point-of-care use during the second quarter.

-    Flu + COVID combo test under review at FDA.

-    Chlamydia + Gonorrhea molecular test is on track for a submission to the FDA planned for the fourth quarter of 2023.

-    Achieved our previously announced cost reduction goal of $150 million of annualized run rate cost savings during the second quarter ahead of our original plan.

-    Ended the second quarter with cash and cash equivalents of $128.6 million and no debt obligations.

“We achieved the top-end of our guidance in the quarter, and expect to return to growth in the second half of the year. We achieved the industry-first FDA De Novo authorization for over-the-counter use of our COVID-19 test, a positive signal for our menu expansion objectives. These include our combination Flu + COVID molecular test and our standalone RSV test, both of which are now under FDA review,” said Ayub Khattak, Chairman and CEO of Cue Health. “Another recent achievement driving our momentum is our new contract with BARDA to develop a Flu + COVID + RSV multiplex test for over-the-counter and point-of-care use. We continue to make good progress on our sexual health menu, with the EUA for our mpox test and our chlamydia & gonorrhea molecular test, which is on-track to submit to the FDA in the fourth quarter. These milestones, together with the early positive signs we’re seeing from Cue Lab and Cue Pharmacy, gives us optimism and confidence in the future of the Cue Health platform.”

Second Quarter 2023 Financial Results

Revenue was $9.9 million for the second quarter of 2023. Private sector revenue was $7.6 million or 76% of total revenue with strong ordering from existing customers. Public sector revenue was $2.3 million and disposable test cartridge revenue was $7.3 million.

GAAP product gross profit was a loss of $21.8 million in the second quarter of 2023 impacted by lower manufacturing volumes and a $11.7 million write-down of excess inventory.

GAAP operating expenses in the second quarter of 2023 were $65.9 million, excluding cost of revenue, including $6.6 million of restructuring expense related to the cost reduction plan. On an adjusted basis, excluding the impact of the restructuring expense, operating expenses were $59.3 million, a sequential decrease of 19% compared to the first quarter and a 37% decrease from $94.6 million in the fourth quarter of 2022. As of the end of the second quarter, the company has achieved the full amount of the previously announced cost reduction goal of $150 million annualized run rate cost savings.

GAAP net loss in second quarter of 2023 was $83.9 million and earnings per diluted share was a loss of $0.55 or an improvement of $0.12 from the second quarter of 2022. Cue's adjusted net loss was $77.2 million and adjusted earnings per diluted share was a loss of $0.51. Adjusted EBITDA was a loss of $53.1 million.

Cash and cash equivalents were $128.6 million as of June 30, 2023 and the company continues to operate with no debt obligations.

Guidance

Cue Health expects third quarter 2023 revenues in the range of $11 million to $13 million.

Source: Cue Health Reports Second Quarter 2023 Financial Results