Is There Still A Path Forward For The Novovax RSV Vaccine?

“While we continue to believe Novavax, Inc. (NASDAQ: NVAX) has an active vaccine for the prevention of RSV (Respiratory syncytial virus), we view a Neutral rating as appropriate given limited visibility on optimal dose/schedule for future development in an elderly population and modest addressable market size for the maternal indication,” Ladenburg Thalmann’s Kevin DeGeeter said in a note, while maintaining a Neutral rating on the company.

RSV Vaccine Update

Novavax reported “uneventful” financial results for fourth-quarter 2016, while also providing an update on its RSV vaccine program.

The company confirmed that it was in discussions with the FDA regarding the potential to an interim analysis to the Phase III maternal vaccination protocol in order to provide an early assessment of efficacy on the primary endpoint of reducing infection severity in the first 90 days after birth.

Novavax also said that it had completed the enrollment of 300 patients for its Phase II trial in an elderly population to assess combinations with alum adjuvant and Matrix-M adjuvant.

In addition, the company also announced that it plans to present the Phase I data of a next generation nanoparticle based seasonal flu vaccine in Q4 2017.

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Q4 And Guidance

Novavax also “refined its guidance for 2017 cash burn from a reduction of $70M-$100M over 2016 levels to a reduction of $80 million–$105 million. The cost reductions should fund operations into 2018, which is beyond potential interim analysis from the Phase III program in a maternal population - we expect preliminary data in 4Q17,” the analyst stated.

For Q4 2016, the company reported revenue of $5.4 million, beating the estimate, driven by the timing of reimbursement from the Gates Foundation for enrollment costs incurred on the Phase III material RSV program.

The EPS for the quarter came in at ($0.21), again beating the estimate, mainly driven by lower than anticipated G&A and R&D expenses.