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Novavax CEO: 'One thing we did was change the relationship with the FDA'

 1 year ago
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Novavax CEO: 'One thing we did was change the relationship with the FDA'

Novavax stock surges amid earnings miss, 25% workforce reduction announcement
 Anjalee Khemlani joining us 
 now to break it all down. 
Novavax stock surges amid earnings miss, 25% workforce reduction announcement
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Anjalee Khemlani
·Senior Reporter
Wed, May 10, 2023, 3:01 AM GMT+9·3 min read

Novavax (NVAX) may have struggled to get its COVID-19 vaccine to market in time during the pandemic, but the company's new CEO is optimistic about the protein-based platform and products sitting in the pipeline.

Key to moving those forward in the near future is a mended relationship with the U.S. Food and Drug Administration (FDA), according to CEO John Jacobs.

"The company had a miss last year. They still had the old Wuhan (strain) vaccine. They were trying to convince the FDA that they were wrong and didn't need the bivalent. Those were well-intended, but didn't pan out to be wise in hindsight, and it hurt the company," Jacobs, who took the helm of the company in January, told Yahoo Finance Tuesday.

"One thing we did was change the relationship with the FDA," he added.

Photo by: STRF/STAR MAX/IPx 2021 1/29/21 Novavax says their two-shot vaccine for COVID-19 shows an efficacy rate of 89.3% in a major Phase 3 clinical trial and was highly effective against a variant first identified in the U.K.. STAR MAX Photo: Novavax logo and COVID-19 virus images photographed off Apple devices.
Photo by: STRF/STAR MAX/IPx 2021 1/29/21 Novavax says their two-shot vaccine for COVID-19 shows an efficacy rate of 89.3% in a major Phase 3 clinical trial and was highly effective against a variant first identified in the U.K.. STAR MAX Photo: Novavax logo and COVID-19 virus images photographed off Apple devices.

That includes a call a week before he started in the new role, initiated by the FDA, Jacobs said.

The two sides have been in communication weekly, and the regulatory agency has been helpful in answering concerns about the new COVID vaccine strain — set to be determined next month — and guidance on the company's flu and combination vaccines currently in clinical trials.

In its first quarter earnings results Tuesday, the company reported revenues of $81 million from its COVID vaccine, compared to $704 million in the first quarter of last year. But the company expects $800 million in 2023 for advance purchase orders and total revenues of $1.4 billion- $1.6 billion for the year.

The company's stock was up on the news Tuesday. It also announced it would reduce its workforce by 25% as part of a planned $50 million in reduction of costs.

Jacobs said he underwent a 12-week process to restructure the company, and is on track to stabilize the company by end of year.

"There were no sacred cows, so to speak. We looked at every department. You have to find that balance of not hurting the capabilities, because you can't cut your way to success, while cutting enough that you can help take that right step towards stabilization," Jacobs said.

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