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Accelerate Diagnostics Reports Preliminary Q4 Revenues of $39K

NEW YORK (360Dx) – Accelerate Diagnostics reported after the close of the market on Monday preliminary fourth quarter revenues of $39,000, which would miss the average analyst estimates of $530,000.

The results come on the heels of last week's de novo clearance from the US Food and Drug Administration to market the Accelerate Pheno system and Accelerate PhenoTest BC kit in the US for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples.

“This is a significant milestone for Accelerate and an important validation of our technology and the performance of our system,” the firm's President and CEO Lawrence Mehren said on a conference call to discuss the financial results and the FDA clearance. He also said the firm has achieved notable commercial progress in both Europe and the US.

The cleared product has 140 assays of which 116 are FDA cleared, and 24 are available to be run in a research-use-only mode, the firm said.

In addition to receiving FDA clearance, Accelerate recently expanded its claims in the European Union by receiving a new CE mark to include all of its tests. As a result, Accelerate now has approval to market the Accelerate Pheno system and blood culture test kits in its target markets of North America and Europe.

For Q4 2016, Accelerate's preliminary R&D costs of $5.2 million would be down from $6.0 million in Q4 2015, while its expected SG&A expenses of $10.2 million would be up 73 percent from $5.9 million in Q4 2015.

For the three months ended Dec. 31, 2016, Accelerate anticipates posting a net loss of $16.1 million, or $0.31 per share, which would beat the average analysts’ estimate of a loss of $0.35 cents per share.

In a 10K filing with the US Securities and Exchange Commission, Accelerate reported full year 2016 revenues of $246,000, up 67 percent from $147,000 in 2015, which missed the consensus Wall Street estimate of $710,000.

Its net loss for 2016 is $66.4 million, or $1.29 per share, which beat the average analysts’ estimate of a loss of $1.32 per share.

Its R&D costs in 2016 rose 8 percent to $28.2 million from $26.0 million in 2015, driven by clinical trial and pre-launch inventory costs, the firm said. For 2016, its SG&A expenses rose 102 percent to $36.2 million, from $17.9 million in 2015, driven primarily by costs associated with the hiring of sales and marketing personnel in European and US operations.

Accelerate reported $77.8 million in cash and investments as of the end of 2016.