Nanoflu vaccine updates
On January 3, Novavax (NVAX) issued a press release announcing positive top-line results from a Phase 2 trial that compared multiple quadrivalent formulations of its Nanoflu vaccine, either with or without Matrix-M adjuvant with two influenza vaccines that are already licensed in the US.
According to the company’s first-quarter earnings conference call, Novavax is working on collecting safety, immunogenicity, and manufacturing data for its Nanoflu vaccine to present to the FDA. According to the company’s first-quarter earnings press release, Novavax expects the FDA to agree to a Phase 3 clinical trial design for Nanoflu based on accelerated approval criteria in the third quarter.
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EPS growth estimates
Analysts expect Novavax’s diluted EPS to change YoY by 26.20% to -$0.37 in fiscal 2019, 21.22% to -$0.29 in fiscal 2020, and 59.07% to -$0.12 in fiscal 2021.
Analysts also expect Novavax’s diluted EPS to change YoY by 22.18% to -$0.09 in the second quarter, 29.48% to -$0.08 in the third quarter, and 30.86% to -$0.09 in the fourth quarter of fiscal 2019.
According to the company’s first-quarter earnings conference call, at the end of the first quarter, Novavax had $108.7 million worth of cash and marketable securities on its balance sheet. The company used $50.6 million in cash for operating activities in the first quarter, a YoY decline of 23.45%. The company expects to spend lower amounts of cash on operating activities in the remaining quarters of fiscal 2019 due to lower spending associated with the Prepare trial. In the first quarter, the company also raised $55 million from its ATM (at-the-money) offering of 84 million shares.