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Pfizer PFE earnings Q1 2021

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A woman holds a small bottle that reads “Coronavirus COVID-19 Vaccine” and a medical syringe in front of the Pfizer logo displayed in this image dated October 30, 2020.

Given Ruvic | Reuters

Pfizer announced on Tuesday that it would apply to German drug manufacturer BioNTech for full US approval of its Covid-19 vaccine at the end of this month. If the FDA signs out, the company can market the shot directly to consumers.

When it released its first quarter financial results, the company reported first quarter sales of $ 3.5 billion for its Covid-19 vaccine, generating profits and sales that exceeded Wall Street expectations.

According to Refinitiv’s average estimates, Pfizer has outperformed Wall Street expectations as follows:

  • Adjusted EPS: 93 cents per share compared to 77 cents expected
  • Revenue: $ 14.58 billion versus $ 13.51 billion expected

The company now expects total annual sales of the vaccine to be $ 26 billion, compared to its previous forecast of approximately $ 15 billion.

Pfizer shares rose 1.4% after the news.

Pfizer’s oncology, internal medicine, hospital and rare disease revenues grew double-digit for the quarter, according to earnings report. The company’s inflammation and immunology division had sales of approximately $ 1 billion, up 9% year over year.

Pfizer saw double-digit sales growth for many of its cancer drugs, including Inlyta, Bosulif, and Lorbrena.

The company received US approval for its Covid vaccine in late December. Since then, the company has distributed millions of cans in the U.S. with a goal of dispensing 300 million cans by the end of July.

It usually takes the Food and Drug Administration nearly a year or more to determine whether a drug is safe and effective for the general public. Due to the one-time pandemic that killed nearly 600,000 Americans, the FDA allowed the gunshots to be used under an Emergency Use Authorization (EUA).

An EEA grants conditional approval based on data for two months. It’s not the same as a biological license application or BLA that takes six months of data and ensures full approval.

The company also expects to apply for an EUA for a booster shot, which could potentially protect against variants in the second half of July. This is evident from a presentation that was attached to the publication of the company’s earnings. Its vaccine is expected to be approved in September for infants and younger children and in November for infants.

On April 1, Pfizer and BioNTech announced that new data from their clinical study showed their two-dose vaccine was safe and greater than 91% effective six months after the second dose. At the time, Albert Bourla, Pfizer CEO, said the new data prompted companies to “file a biologics license application with the US FDA.”

When the vaccine is fully approved, Pfizer and BioNTech can begin promoting the shots directly to consumers and changing prices. It also allows the shot to stay in the market once the pandemic is over and the US is no longer considered an “emergency”.

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Robert Dunfee