Pfizer (PFE) said Tuesday it plans to seek full Food and Drug Administration approval for its Covid-19 vaccine by the end of the month. Pfizer stock edged higher.
As it is, the Covid vaccine is allowed for emergency use. Full approval would allow the Pfizer and BioNTech (BNTX) vaccine to stay on the market after the pandemic ends. Further, the companies could market directly to consumers and change the price.
The news comes as Pfizer reported $3.46 billion in first-quarter sales of the vaccine, accounting for nearly one-quarter of total sales. Pfizer also raised its 2021 outlook, partially reflecting the strong vaccine sales.
Still, the quarter was bullish even without the Covid vaccine, Chief Executive Albert Bourla said in a written statement. Excluding the Covid vaccine contribution, Pfizer reported 8% operational sales growth, beating its own goals, he said.
Pfizer stock, which was down throughout much of the day, managed to gain a fraction to close at 39.95. Shares jumped more than 3% on Monday, putting Pfizer stock in a buy zone above a buy point at 39.77 out of a cup-with-handle base, according to MarketSmith.com.
Pfizer Stock Sees Strong Quarter
Overall, Pfizer sales soared 42% to $14.58 billion. That easily topped the forecast of analysts polled by FactSet for $13.65 billion. Adjusted profit was 93 cents per share, climbing 47% to top expectations for 78 cents.
The company also raised its guidance for 2021. Now, Pfizer calls for $70.5 billion to $72.5 billion in sales, up more than $11 billion at the midpoint from its prior call. Adjusted earnings are expected to be $3.55-$3.65 per share. Pfizer stock analysts called for earnings of $3.21 a share and $61.6 billion in sales.
Now, Pfizer expects $26 billion in full-year sales of its Covid vaccine. This is based on roughly 1.6 billion doses expected to be delivered in 2021 under contracts inked as of mid-April. That number is likely to grow. The New York Times said Monday the vaccine could gain FDA authorization in teens age 12-15 as soon as next week.
Meanwhile, Pfizer says it’s planning to seek authorization for a Covid booster in mid-July, pending additional test data earlier in the month. It expects to have data from tests in children ages 2-5 and 5-11 in September, and from children ages 6 months to 2 years in November.
‘Multiple Moving Parts’
The quarter was also marked by strong performance from Eliquis, an anticoagulant partnered with Bristol Myers Squibb (BMY). Sales grew 26% on an as-reported basis to $1.64 billion. That beat forecasts by $271 million, Mizuho Securities analyst Vamil Divan said in a report to clients.
Other key drugs, pneumonia vaccine Prevnar 13 and cancer med Ibrance, came in light at $1.28 billion and $1.25 billion, respectively. That was likely expected amid Covid-related challenges and commentary from competing companies such as Merck (MRK) and Eli Lilly (LLY), Divan said.
Meanwhile, rare disease drugs Vyndaqel/Vyndamax generated $453 million, nearly doubling year over year. Xeljanz, a rheumatoid arthritis treatment, brought in $538 million, increasing 19%.
“There remain multiple moving parts to the Pfizer story right now, but we believe most of their core assets are performing well and are impressed by their success with the Covid-19 vaccine, which we think bodes well for improved (research and development) productivity and pipeline success to improve the company’s 2026-30 outlook,” Divan said.
Divan kept his buy rating and 42 price target on Pfizer stock.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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