Novavax (NVAX) is readying its forces to be a fully commercially-licensed company by the end of 2023, with a strong balance sheet and the workforce to achieve the endpoint.
This follows the company’s bumpy ride throughout the pandemic, with investor sentiment significantly down on the company.
It’s a bit of deja vu for outgoing CEO Stanley Erck, who spoke with Yahoo Finance at the annual JPMorgan Healthcare Conference in San Francisco this week.
In January 2020, at the beginning of the pandemic, the company was “down to 100 people, down to $100M market cap, and down to enough money to get through May that year,” Erck said.
Today, the company boasts a commercial product that is approved in 47 countries in the past year, roughly 2,000 employees, over $1 billion in the bank, and ened 2022 with a record $2 billion revenue from year one of sales.
But the company’s stock price has plummeted from a pandemic high of more than $280 per share to about $12 per share. Erck attributes the decline to the company’s inability to crack the U.S. market. While Novavax has received dozens of approvals globally, and has delivered millions 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 company overcame its early manufacturing quality struggles. He is cognizant of the millions invested by the U.S. government to get the vaccine to the finish line.
“The government has to get out of the way,” Erck said.
“They tell us that they want to get out of the way. But I don’t know what keeps them. I think that the FDA has been slow to review and approve all the different aspects of our vaccine. And it’s not that they don’t approve it, it’s just that they take the maximum amount of time to do it, and it hurts (us),” he added.
The regulatory agency has yet to approve the vaccine, still based on the original Wuhan strain, for an additional booster. Meanwhile mRNA vaccines have been authorized in the new bivalent formula for additional boosters.
But Novavax isn’t waiting around. It is currently readying for the commercial market, which will begin once the public health emergency declaration in the U.S. ends.
“We’re building a U.S. commercial marketing team — not just starting, we’re in the process of it — and that team is going out to physicians, to the CVS’s, Walgreens and Rite Aids,” Erck said.
“What we expect is that by the second half of this year … We’ll be ready and commercialize it,” he added.
The thing Erck looks forward to gaining from access to the commercial market is increased volume of real world data about the vaccine’s durability.
“We’re getting data that suggests it’s more durable” which could help the company as concerns swirl about the quick loss of antibody levels with mRNA vaccines — especially an issue for the elderly and more vulnerable populations.
Meanwhile, Erck said Novavax is also now focused on its pipeline. Prior to the pandemic, the company had been in late stage trials for flu.
“In January (2020), we were 3 months away from unblinding the phase 3 trial. When we did, no one cared. It sat on the shelf for almost 2 years,” Erck said.
Had it not been for the pandemic, the company could have had a commercial 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 in the industry, will remain with the company for several months through the transition. But after that, plans are unknown.
“Stan doesn’t have a plan yet,” Erck joked. “I haven’t had time to plan for Stan.”
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Source: https://finance.yahoo.com/news/outgoing-novavax-ceo-the-government-has-to-get-out-of-the-way-194311386.html