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Chembio Q4 Revenues Jump 62 Percent, Beat Estimates 

NEW YORK – Chembio Diagnostics reported after the close of the market Thursday that its fourth quarter revenues rose 62 percent year over year. 

The Hauppauge, New York-based diagnostics maker reported total Q4 revenues of $10.2 million, up from $6.3 million a year ago and handily beating analysts' average estimate for $5.8 million. The firm said that its Q4 net product revenues were up 39 percent to $6.9 million compared to $4.9 million in Q4 2019, and that its license, royalty, R&D, and grant revenues were $3.4 million compared to $1.4 million a year ago. 

In the recently completed quarter, Chembio received notice that FDA was declining to review its antigen test system, although the firm noted that the agency later advised on the type of information a subsequent Emergency Use Authorization submission would need to prioritize its review. 

"While we have faced challenges on the regulatory front regarding our portfolio of COVID-19 tests, we remain committed to obtaining FDA approval for these tests," Richard Eberly, Chembio's president and CEO, said in a statement.  

Meantime, Chembio inked a distribution deal for an unspecified Emergency Use Authorized assay that is scheduled to launch this month. It also obtained CE mark and regulatory authorization in Brazil for its SARS-CoV-2 antigen test system and CE mark for its IgM/IgG antibody system.  

Chembio was also recently awarded $12.7 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for the development of a respiratory antigen panel for use on its DPP platform and to gain Emergency Use Authorization from the US Food and Drug Administration for the test. The funding will also go toward the preparation and potential receipt of 510(k) clearance for the rapid DPP SARS-CoV-2 Antigen System.

Chembio's net loss for the quarter widened to $7.1 million, or $.35 per share, compared to a loss of $3.9 million, or $.23 per share, for the fourth quarter of 2019. Analysts on average expected a net loss of $.28 per share. 

The firm's Q4 R&D expenses were $3.3 million, an increase of 65 percent from $2.0 million the prior year, due to clinical trial expenses related to development of the DPP SARS-CoV-2 Antigen and DPP Respiratory Panel test systems. Chembio's SG&A expenses nearly doubled to $7.1 million from $3.6 million, which the firm attributed to the expansion of the US commercial organization as well as legal expenses and facility costs related to the COVID-19 pandemic. 

For full year 2020, Chembio's total revenues were down 6 percent year over year to $32.5 million from $34.5 million but still beat the consensus Wall Street estimate of $28.0 million. Net product sales dropped 14 percent to $24.8 million from $28.8 million, while grant, license and royalty, and R&D revenues increased 37 percent to $7.7 million from $5.6 million.  

In October, the firm received FDA premarket approval for an HIV and syphilis assay that it has said it expects to attract more customers to its DPP system in the US. 

The firm also expanded and automated its manufacturing capabilities in 2020.  

Chembio's net loss for 2020 climbed to $25.5 million, or $1.34 per share, compared to a net loss of $13.7 million, or $0.81 per share, for FY 2019. The consensus Wall Street estimate was a loss per share of $1.24.

Its 2020 R&D expenses grew 12 percent year over year to $9.5 million from $8.5 million. Its SG&A spending increased 30 percent to $21.0 million from $16.1 million, which the firm attributed to the expansion of its US commercial organization, legal expenses, and a full year of operations for Chembio's facility in Brazil following its acquisition in the fourth quarter of 2019, offset somewhat by the retrenchment of its Malaysia facility in May 2020.  

Chembio finished the year with $23.1 million in cash and cash equivalents. 

In Friday morning trading on the Nasdaq Chembio's stock was down 8 percent to $4.55.