Co-Diagnostics, Inc. reports full year 2023 financial results

Co-Diagnostics, Inc. announced financial results for the full year ended December 31, 2023.

Full year 2023 financial results:

• Revenue of $6.8 million, down from $34.2 million during the prior year primarily due to the decline in global demand for the Logix Smart® Covid-19 tests. Grant revenue totaled $5.8 million while product revenue totaled $1.0 million
• Operating expenses of $45.3 million decreased by 18.6% from the prior year due to goodwill impairment charges in the prior year, offset by an increase in research and development costs incurred for the development of our Co-Dx™ PCR platform in the current year
• Operating loss of $42.7 million compared to operating loss of $27.0 million in 2022
• Net loss of $35.3 million, compared to net loss of $14.2 million in the prior year, representing a loss of $1.20 per fully diluted share, compared to a loss of $0.45 per fully diluted share in the prior year
• Adjusted EBITDA loss of $33.0 million
• Repurchased approximately 967,000 shares of common stock at an average price of $1.41 per share for an aggregate purchase price of approximately $1.4 million<
• Cash, cash equivalents, and marketable securities of $58.5 million as of December 31, 2023

Full year 2023 business highlights:

• Initiated and completed the clinical evaluations for the first test on the new Co-Dx PCR point-of-care and at-home platform
• Submitted an EUA to the FDA in December for our Co-Dx PCR Pro™ instrument, mobile app, and Co-Dx Covid-19 test kit
• Awarded grant funding in the aggregate amount of approximately $12.6 million in 2023, to be applied towards regulatory and clinical validation activities for the development of our tuberculosis (TB) test, upper respiratory multiplex (flu A/B, Covid-19, and RSV) panel, and human papillomavirus (HPV) test, which include:
  • Three awards from the Bill and Melinda Gates Foundation to support the development of tuberculosis and HPV tests and expansion of manufacturing capacity; and
  • An award from the NIH as part of the Rapid Acceleration of Diagnostics (RADx^®) Tech program for upper respiratory multiplex panel
• Appointed Ivory Chang as Chief Regulatory Affairs Officer. Chang previously worked at multiple large, renowned diagnostic companies, and brings many years of experience to Co-Diagnostics in in-vitro diagnostic product and point-of-care regulatory submissions
• Built out new manufacturing facility which will serve to support production of our test cups and Co-Dx PCR Pro instruments

“We are pleased to have made great progress towards our strategic goals in the fourth quarter, highlighted by an Emergency Use Authorization submission to the FDA for our Co-Dx PCR Pro™ instrument, mobile app, and Covid-19 test,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “We believe that our EUA submission will serve as a steppingstone in our effort to decentralize PCR diagnostics and to expand to the point-of-care and at-home settings. Co-Diagnostics’ investment in additional production capacity in Salt Lake City also includes the manufacturing of our Co-Primers™ in-house, to lower costs. We are currently building expanded capacity for test cup and instrument manufacturing lines in India as well, in addition to capability to support Co-Primers manufacturing in the near future.”

“We remain excited for 2024 and look forward to providing updates on our test development and platform. Co-Diagnostics plans to continue the development of our TB, multiplex respiratory, and HPV tests throughout the year,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer.
MB Bureau