CEO acknowledged on an earnings call late Tuesday that the company wouldn’t be able to apply for emergency-use authorization for its Covid-19 vaccine until after June, one more delay in a timeline that has stretched farther and farther in recent months.
The postponement raises further worries that
(ticker: NVAX) vaccine, which demonstrated surprisingly good efficacy in a large trial in the U.K., will miss out on the near-term Covid-19 vaccine market.
Shares were down 12.1% in premarket trading on Tuesday. The stock has fallen 32.3% so far this month, though it is still up 43.9% this year. On Monday, Novavax shares fell 8.8% after the Washington Post reported on the vaccine delays.
“It is not likely that we’ll finish this work in time to submit by the end of June, so I’m changing our guidance to reflect that we expect to complete our regulatory filings in the third quarter,” said Novavax CEO Stanley Erck on the Tuesday call.
The company had previously planned to submit a request for authorization from UK regulators by “early second quarter”, and to do so with the U.S. Food and Drug Administration in the second quarter.
Erck said that raw-material shortages had slowed the process of getting the company’s manufacturing capacity up to speed. He said that, while the company had previously aimed to have manufacturing “at full operating cadence” by the end of the third quarter, he now expected that the manufacturing network wouldn’t operate at full capacity until the fourth quarter.
Investors have been waiting for data from a continuing Phase 3 trial of the vaccine in the U.S. and Mexico. Erck said that final data will be available in the second quarter. “We look forward to sharing our results with you in a few weeks,” he said.
Novavax reported a net loss of $3.05 per share, slightly better than the FactSet consensus estimate of $3.60 per share. Revenues for the first quarter were $447 million, while research and development expenses were $593 million.
The company said it would be able to make 100 million doses of its vaccine a month by the end of the third quarter, and 150 million doses a month by the fourth quarter.
Despite the delayed timeline, Jefferies analyst Kelechi Chikere said that the long-term outlook for the company remains intact.
“While the delays are clearly disappointing, we remain constructive on the name and see the outlook as promising given the clear high efficacy, clean safety profile, robust data package and optionality for a multivalent and/or [Covid-19/flu] combo vaccine,” Chikere wrote.
Still, Chikere, who rates the stock a Buy, lowered his target for the stock price to $235, from $310. The stock closed Monday at $160.50.
Chikere said that he had cut his expectations for Novavax’s Covid-19 vaccine revenue in 2021 to $2 billion, from $5 billion, but increased his estimated 2022 Covid-19 vaccine revenue for the company to $4 billion, from $3 billion.
“Investors will be disappointed as it means sales in 2021 are likely to be modest, mRNA vaccines have more time to gain mindshare and more vaccines potentially enter the [market],” Chikere wrote. “While recognizing the [near-term] headwinds, we remain [positive] on the mid to long-term outlook for NVAX’s CV-19 vaccine [program].”
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