Novavax Inc. (NASDAQ: NVAX) reported its fourth-quarter financial results before the markets opened on Monday. The company said it had a net loss of $0.29 per share on $5.9 million in revenue, which compares to consensus estimates from Thomson Reuters of a net loss of $0.14 per share on revenue of $8.07 million. In the same period of the previous year, it posted a net loss of $0.13 per share and $6.72 million in revenue.
In the fourth quarter, the company completed enrollment of 1,330 older adults in a Phase 2 rollover clinical trial of its RSV F Vaccine in older adults enrolled in the prior Phase 2 trial. The trial is a randomized, observer-blinded, placebo-controlled rollover trial designed to enroll from the population of 1,600 older adults who participated in the prior Phase 2 trial.
Novavax initiated the enrollment in a global pivotal Phase 3 clinical trial, known as Prepare, of its RSV F Vaccine in healthy pregnant women. Prepare is a randomized, observer-blinded, placebo-controlled trial that utilizes a group sequential design, thus, the eventual sample size may vary between 5,000 and 8,255 pregnant women over a period of two to four years.
Stanley C. Erck, president and CEO of Novavax, commented on earnings:
During the fourth quarter, we initiated two pivotal Phase 3 trials of our RSV F Vaccine, and subsequently completed enrollment of our Resolve trial in older adults. We expect to announce value-creating data from the Resolve trial and the Phase 2 rollover trial in older adults in 2016. In addition, we recently strengthened our balance sheet through the successful completion of a convertible note offering, providing the necessary resources for the continued execution of our business plan.
On the books, the company had $230.7 million in cash, equivalents and marketable securities at the end of the fourth quarter, compared to $168.1 million in the same period from last year.
Shares of Novavax were down 8.6% at $4.31 Monday morning, with a consensus analyst price target of $16.35 and a 52-week trading range of $4.08 to $15.01.
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