Yahoo Finance Novavax CEO: 'One thing we did was change the relationship with the FDA'
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.
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.
Though the COVID-19 pandemic is over, Novavax's is still dedicated to getting it's COVID vaccine out in time for fall shots, according to R&D president Dr. Filip Dubovsky.
"Our focus is really getting the current vaccine out. This is our number priority. That's where all our resources are going," Dubovsky told Yahoo Finance.
But outside of that, the company is focused on Phase 2 results for its flu vaccine candidate, which still need to be analyzed, and a combination flu/Covid vaccine.
Dubovsky said that because of the attention to the COVID vaccine, other candidates were somewhat sidelined. That means it will take time before the company has a new product on the market.
"We didn't budget for the clinical work for any of these pipeline products. So to move them forward, it's going to have to be strategic partnerships," Dubovsky said.
Which is also why the repaired relationship with the FDA is important.
"We'd want to get assurances from the regulatory agencies that we had the right approach, design. And if we do it with partnerships, you can imagine that the partner would want to be involved in the design and timing of the future work to be done," Dubovsky said.
He added that all that culminates to a path forward, but no clarity on a potential filing date for the newer products.
Follow Anjalee on Twitter @AnjKhem
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