The final months of 2021 represented “a very transformational quarter” for Novavax Inc. — and the Gaithersburg vaccine maker expects that to continue this year, CEO Stanley Erck said on a company earnings call Monday.
“We expect this momentum will only accelerate,” Erck said on the call. The biotech will seek full approval of its Covid-19 vaccine candidate in the U.S. in the second half of 2022, he said. Novavax (NASDAQ: NVAX) submitted its emergency use authorization application in January to the Food and Drug Administration for that product — which has received now more than $2 billion in total public funding through the federal government's Operation Warp Speed, Department of Defense and Coalition for Epidemic Preparedness Innovations — and is now awaiting the agency’s review.
“We’re going full blast for our EUA,” Filip Dubovsky, Novavax’s chief medical officer, said on the call. “We’re in contact with the FDA periodically to make sure all the questions are answered, so looking forward to moving forward with that.”
He couldn't, however, offer any specifics in terms of time frame. “As you know, we don't control the pace they review the filing, we're looking forward to a successful of our packet in the near future,” he told analysts.
Related: Read our cover story on Novavax's dramatic evolution through the Covid pandemic.
The company also reported Monday that its protein-based vaccine showed protection against Covid infection lasting over six months, per new data from a late-stage clinical trial in the United Kingdom.
Novavax has earned authorizations for its coronavirus vaccine with 12 regulatory agencies across 38 countries, with plans to sell its product under the Covovax brand in Bangladesh and India and under the Nuvaxovid brand in Canada, Singapore, New Zealand, Australia, South Korea and Great Britain, among others. It has also secured an emergency use listing from the World Health Organization, which gives it the possibility of reaching another 130 countries. The company intends for its vaccine to be used as a primary defense against the virus, and as a booster and in pediatric populations specifically.
Given entry into those markets and deals to produce its vaccine, the company is forecasting total revenue of $4 billion to $5 billion for this year, up significantly from the $1.15 billion it reported for 2021. And for a business that nearly imploded just two years ago, that’s more than a big deal.
“We’re a revenue-generating company. We’ve got obligations to support that revenue generation and report on that. We’re very excited by this,” Erck said on the company earnings call. “We’ve now got a manufacturing process that's been approved by virtually the world. We’ve got regularity to our shipping. We've got good cadence.”
Novavax has reached its goal of having the capacity to manufacture more than 2 billion doses a year “to meet the current and future global demand for our vaccine,” Erck reiterated Monday. After buying Czech Republic company Praha Vaccines, and its manufacturing facility, for $167 million in 2020, Novavax spent much of last year inking new manufacturing partnerships to help up its supply of the Covid vaccine, including with Mabion SA in Poland, Fujifilm Diosynth Biotechnologies both domestically and in the U.K., and the National Research Council of Canada for a new biologics manufacturing center there.
The company still plans to advance a combination Covid-flu vaccine, Erck said on the call, calling it “a key component of our pipeline.” Novavax expects to report data in April from an early study, and start a phase 2 trial intended to “bring us one step closer to pursuing licensure of our product,” Erck said.
It reported a near doubling of its workforce, from 791 in February 2021 to 1,541 full-time employees worldwide as of this year, with a big jump in its corporate, business development and sales teams, which grew from 139 people last year to 453 this year. It counted $1.5 billion in cash and equivalents as of the end of last year, a jump from $806.4 million a year prior.
Novavax’s share price opened Tuesday at $79.46, before climbing to a high of $91 for the day. The stock was trading up 1.33% to $84.48 per share by late afternoon.
