Novavax is building a US commercial marketing team, says outgoing CEO Erck

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Novavax (NVAX) is preparing to be a fully commercially licensed company by the end of 2023, with a strong balance sheet and workforce to reach the end point.

This follows the company’s bumpy ride during the pandemic, which saw investor sentiment significantly lower than the company.

It’s a bit of deja vu for outgoing CEO Stanley Erck, who spoke to Yahoo Finance this week at the annual JPMorgan Healthcare Conference in San Francisco.

In January 2020, at the start of the pandemic, the company had “less than 100 people, a market cap of $100 million and enough money to get through May of that year,” Erck said.

Today, the company boasts a commercial product approved in 47 countries in the past year, approximately 2,000 employees, more than $1 billion in the bank, and ended 2022 with record $2 billion in sales from its first year of sale.

But the company’s stock price has fallen 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 US market. Although Novavax has received dozens of approvals worldwide and delivered millions of doses outside the US, it has struggled with a strained relationship with the FDA.

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Erck said he doesn’t understand why the FDA has dragged on with approvals and distribution of the Novavax vaccine, even after the company overcame its early manufacturing quality issues. He is aware of the millions invested by the US government to get the vaccine to the finish line.

“The government should get out of the way,” Erck said.

“They tell us they want to get out of the way. But I don’t know what’s stopping them. I think the FDA has been slow to review and approve all the different aspects of our vaccine. don’t approve, it’s just that they take the maximum amount of time to do it, and it hurts (us),” he added.

The regulatory body has yet to approve the vaccine, still based on the original Wuhan strain, for an additional booster. mRNA vaccines have now been admitted in the new bivalent formula for extra boosters.

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Vials labeled “VACCINE Coronavirus COVID-19” and a syringe can be seen in front of a rendered Novavax logo in this illustration, taken Dec. 11, 2021. REUTERS/Dado Ruvic/Illustration

But Novavax is not waiting. It is currently being readied for the commercial market, which will begin once the US public health emergency ends.

“We’re building a commercial marketing team in the US — not just getting started, we’re on it — and that team is going to doctors, to the CFSs, Walgreens and Rite Aids,” Erck said.

“What we expect is to be ready and in the market in the second half of this year,” he added.

What Erck looks forward to getting into the commercial market is a greater set of real-world data on the vaccine’s sustainability.

“We’re getting data that suggests it’s more durable,” which could help the company address concerns about the rapid loss of antibody levels with mRNA vaccines — especially a problem for the elderly and more vulnerable populations.

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Meanwhile, Erck said Novavax is now also focused on its pipeline. Prior to the pandemic, the company was in the late stages of flu trials.

“In January (2020), we were 3 months away from unblinding the phase 3 trial. When we did, nobody cared. It was shelved for almost 2 years,” said Erck.

Had it not been for the pandemic, the company could have had a commercial flu vaccine that Erck said would have been successful.

But that burden now falls on new CEO John Jacobs, who will take up his position later this month following his departure from Harmony Biosciences.

Erck, who has been in the industry for 40 years, will remain with the company for several months during the transition. But after that, the plans are unknown.

“Stan doesn’t have a plan yet,” Erck joked. “I haven’t had time to make plans for Stan.”

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