Novavax (NVAX) Reports In-Line Q2 EPS, Revenues Beat

Novavax (NASDAQ: NVAX) reported Q2 EPS of ($0.12), in-line with the analyst estimate of ($0.12). Revenue for the quarter came in at $10.77 million versus the consensus estimate of $9.94 million.

“In keeping with our stated 2018 objectives, Novavax reached two important milestones in the second quarter for our lead ResVax™ and NanoFlu™ programs,” said Stanley C. Erck, Novavax President and CEO. “With ResVax, we achieved a critical enrollment goal in the Prepare™ trial, enabling us to reach agreement with the FDA to initiate a final efficacy analysis in the first quarter of 2019. This analysis will be used to support the future BLA and MAA in the U.S. and Europe, respectively.”

“On the NanoFlu front,” Mr. Erck continued, “the data published in The New England Journal of Medicine demonstrated that NanoFlu induced significantly improved immune response compared to the current leading high-dose influenza vaccine. We are on track to initiate a Phase 2 clinical trial of quadrivalent formulations of NanoFlu in the third quarter of this year. Pending successful Phase 2 data, based on discussions with the FDA, we anticipate initiating a Phase 3 immunogenicity clinical trial that may provide the basis of licensure via the FDA’s accelerated approval pathway.”

For earnings history and earnings-related data on Novavax (NVAX) click here.

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