‘The federal government has to get out of the best way’

Novavax (NVAX) is readying its forces to be a totally commercially-licensed company by the tip of 2023, with a powerful balance sheet and the workforce to realize the endpoint.

This follows the corporate’s bumpy ride throughout the pandemic, with investor sentiment significantly down on the corporate.

It is a bit of deja vu for outgoing CEO Stanley Erck, who spoke with Yahoo Finance on the annual JPMorgan Healthcare Conference in San Francisco this week.

In January 2020, initially of the pandemic, the corporate was “right down to 100 people, right down to $100M market cap, and right down to enough money to get through May that 12 months,” Erck said.

Today, the corporate boasts a business product that’s approved in 47 countries prior to now 12 months, roughly 2,000 employees, over $1 billion within the bank, and ened 2022 with a record $2 billion revenue from 12 months one in every of sales.

But the corporate’s stock price has plummeted from a pandemic high of greater than $280 per share to about $12 per share. Erck attributes the decline to the corporate’s inability to crack the U.S. market. While Novavax has received dozens of approvals globally, and has delivered thousands and thousands of doses ex-U.S., it has struggled with a tense relationship with the FDA.

Erck said he doesn’t understand why the FDA has dragged its feet with approvals and distribution of Novavax’s vaccine, even after the corporate overcame its early manufacturing quality struggles. He’s cognizant of the thousands and thousands invested by the U.S. government to get the vaccine to the finish line.

“The federal government has to get out of the best way,” Erck said.

“They tell us that they need to get out of the best way. But I do not know what keeps them. I believe that the FDA has been slow to review and approve all the various facets of our vaccine. And it isn’t that they do not approve it, it’s just that they take the utmost period of time to do it, and it hurts (us),” he added.

The regulatory agency has yet to approve the vaccine, still based on the unique Wuhan strain, for a further booster. Meanwhile mRNA vaccines have been authorized in the brand new bivalent formula for added boosters.

Vials labelled “VACCINE Coronavirus COVID-19” and a syringe are seen in front of a displayed Novavax logo on this illustration taken December 11, 2021. REUTERS/Dado Ruvic/Illustration

But Novavax is not waiting around. It’s currently readying for the business market, which can begin once the general public health emergency declaration within the U.S. ends.

“We’re constructing a U.S. business marketing team — not only starting, we’re within the technique of it — and that team goes out to physicians, to the CVS’s, Walgreens and Rite Aids,” Erck said.

“What we expect is that by the second half of this 12 months … We’ll be ready and commercialize it,” he added.

The thing Erck looks forward to gaining from access to the business market is increased volume of real world data concerning the vaccine’s durability.

“We’re getting data that means it’s more durable” which could help the corporate as concerns swirl concerning the quick lack of antibody levels with mRNA vaccines — especially a difficulty for the elderly and more vulnerable populations.

Meanwhile, Erck said Novavax can also be now focused on its pipeline. Prior to the pandemic, the corporate had been in late stage trials for flu.

“In January (2020), we were 3 months away from unblinding the phase 3 trial. After we did, nobody cared. It sat on the shelf for nearly 2 years,” Erck said.

Had it not been for the pandemic, the corporate could have had a business flu vaccine that Erck said would’ve been successful.

But that burden now falls on incoming CEO John Jacobs, who will begin the job later this month after leaving Harmony Biosciences.

Erck, who has spent 40 years within the industry, will remain with the corporate for several months through the transition. But after that, plans are unknown.

“Stan doesn’t have a plan yet,” Erck joked. “I have never had time to plan for Stan.”

Follow Anjalee on Twitter @AnjKhem

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