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Co-Diagnostics Q3 Revenues Soar on Coronavirus Test Sales as Firm Gains Two More CE Marks

NEW YORK — Co-Diagnostics on Tuesday reported third quarter revenues of $21.8 million, compared with $41,434 in the year-ago period. The steep increase was primarily due to sales of its Logix Smart COVID-19 test for SARS-CoV-2.

Separately on Tuesday, the Salt Lake City-based company said that it received CE marks for two additional SARS-CoV-2 tests.

The PCR-based Logix Smart COVID-19 test, which is designed to detect the SARS-CoV-2 RdRp gene, received CE-IVD marking in February and Emergency Use Authorization from the US Food and Drug Administration in April.

Around $1.5 million of Co-Diagnostics' Q3 revenues was related to sales of third-party manufactured equipment and consumables sold to customers to facilitate sales of the SARS-CoV-2 test. The company also said that its Indian joint venture CoSara Diagnostics recorded $3.0 million in third quarter sales, including from SARS-CoV-2 tests.

"Co-Diagnostics continues to see widespread uptake of our COVID-19 test domestically and abroad, and we believe our customer and distributor bases are laying the foundation for a strong future," Co-Diagnostics CEO Dwight Egan said in a statement. "Development projects both completed and ongoing have helped position Co-Diagnostics as a key player in the battle against the coronavirus pandemic, including receipt today of two important CE markings."

The CE marks are for its Logix Smart ABC assay, a combination test for influenza A/B and SARS-CoV-2, and Logix Smart SARS-CoV-2 multi-gene test, which detects both the RdRp and E genes of the virus. Both PCR-based tests use saliva and other respiratory tract samples such as nasal swabs.

For the three-month period ended September 30, Co-Diagnostics post a net profit of $15.7 million, or $.53 per share, versus a loss of $1.7 million, or $.10 per share, a year earlier.

R&D spending in the third quarter almost tripled to $921,889 from $331,027 the year before as the company advanced additional tests through its pipeline, including the newly CE marked tests, and planned SARS-CoV-2 tests that do not require an RNA extraction step.

Third quarter SG&A costs, meantime, more than doubled to $3.0 million from $1.3 million last year.

At the end of September, Co-Diagnostics had cash and cash equivalents totaling $21.2 million.

During early morning trading on the Nasdaq, shares of Co-Diagnostics were down 13 percent to $11.79.