‘The government has to get out of the way’

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 comes after the company’s turbulent ride during the pandemic. Investor sentiment is significantly down.

Stanley Erck, the outgoing CEO, has a feeling of déjà vu. Erck spoke to Yahoo Finance this week at the JPMorgan Healthcare Conference in San Francisco.

Erck explained that in January 2020, just before the outbreak, the company had “down to 100 people”, a market capital of $100M and sufficient money to last May.

Today, the company boasts a product that has been approved in 47 countries, approximately 2,000 employees, more than $1 billion in bank accounts, and an estimated $2 billion in revenue for 2022.

However, the stock price of the company has fallen from a pandemic peak of over $280 per share down to $12 per share. Erck attributes the company’s failure to penetrate the U.S. markets to the decline. Novavax has been approved for dozens of drugs worldwide and shipped millions of doses outside the United States. However, it has had a difficult relationship with FDA.

Erck said that he didn’t get why the FDA has been slow in approving Novavax’s vaccine and distribution, even though the company had overcome its difficulties. early manufacturing quality struggles. He is well aware of the U.S. Government’s millions spent to get the vaccine to market.

Erck stated that “the government must get out the way”.

“They tell me that they want to get away from us. But I don’t know what keeps them. I believe that the FDA has taken too long to review and approve every aspect of our vaccine. He said that it is not that they won’t approve it. It’s just that it takes them the most time and it hurts us.

The vaccine is still based on the original Wuhan strain and has not been approved by the regulatory agency. The bivalent formula now allows for mRNA vaccines as an additional booster.

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Novavax doesn’t wait. Novavax is currently preparing for the commercial market. This will occur once the U.S. public health emergency declaration has been lifted.

“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 anticipate is that by the 2nd half of this year,… We will be ready to commercialize it,” he said.

Erck is looking forward to more real-world data on the vaccine’s longevity from the commercial market.

“We are getting data that suggests it is more durable,” which could be a benefit to the company, as there are concerns about the sustainability of the firm’s operations. quick loss of antibody levels with mRNA vaccines — especially an issue for the elderly and more vulnerable populations.

Erck stated that Novavax is now focusing on its pipeline. The company was in the final stages of flu trials before the pandemic.

“In January 2020 we were only three months away unblinding phase 3. No one noticed that we had done it. Erck stated that it sat on the shelf almost two years.”

Erck claimed that the company would have been able to produce a commercial influenza vaccine if it hadn’t been for the pandemic.

John Jacobs, the incoming CEO of Harmony Biosciences, will now shoulder that responsibility. He will take up the position later this month.

Erck, who spent over 40 years in the business, will continue to be with the company during the transition. However, future plans are not known.

Erck jokingly said, “Stan doesn’t have a plan yet.” Stan hasn’t been able to plan yet, so I don’t have the time.

Follow Anjalee Twitter @AnjKhem

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