Pfizer (NYSE: PFE) to beat expectations when it reports third-quarter 2021 results on Nov 2, before the market open. In the last reported quarter, the company beat earnings expectations by 10.31%.
Factors to Note:
A key contributor to Pfizer’s sales in the third quarter is likely to have been its and partner BioNTech’s BNTX COVID-19 vaccine, Comirnaty. Sales are expected to be higher than second-quarter sales of $7.8 billion.
Higher sales of Pfizer’s key brands, Eliquis [alliance revenues from Bristol Myers BMY], Xtandi and Inlyta, and significant contribution from newer drug Vyndaqel/Vyndamax and higher biosimilar revenues are likely to have contributed to sales growth in the third quarter of 2021.
Sales of Prevnar 13/Prevenar 13 vaccine, which were hurt significantly by the pandemic in the previous quarters, improved in the United States in the second quarter. We expect the positive trend to have continued in the third quarter.
Ibrance sales are likely to have risen outside U.S. markets, which might have made up for lower sales in the United States.
The Zacks Consensus Estimate for oncology and vaccine products is $3.19 billion and $14.51 billion, respectively.
However, sales of some key drugs like Chantix in the United States and Enbrel in international markets are likely to have declined in the third quarter, continuing the trend of the past few quarters. While Chantix sales are expected to have been hurt by the loss of exclusivity, sales of Enbrel in key European markets and Japan are likely to have been hurt by biosimilar competition.
R&D costs are expected to have been higher in the third quarter due to incremental spending on COVID-19 vaccines and antiviral medicines as well as other mRNA-based programs.
Key Recent Development:
Last month, the FDA granted emergency use authorization (EUA) to a booster or “third” dose of Comirnaty for individuals 65 years and older and those in high-risk groups.
The high-risk groups include individuals aged 16 to 64, at a high risk of severe COVID-19, and those whose occupation exposes them to the virus and puts them at a high risk of COVID-related complications, including severe COVID-19, like healthcare workers, teachers, and others. However, in line with the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA did not approve the booster dose for the entire population for which Pfizer/BioNTech was seeking approval. Pfizer/BioNTech had filed its supplemental biologics license application (sBLA), seeking approval for the booster dose of Comirnaty, in people 16 years of age and older, in August.
Pfizer’s pivotal phase II/III study showed that its COVID-19 vaccine was safe, well-tolerated, and initiated robust neutralizing antibody responses in children 5 to 11 years of age. Data from the study cohort showed that one month of immunization with two doses of Comirnaty resulted in SARS-CoV-2–neutralizing antibody geometric mean titer levels that were non-inferior to the level achieved in individuals aged 16 to 25 years of age in the previously completed clinical study. This week, the VRBPAC voted in favor (17 to 0, with one abstention) of the FDA granting EUA to Comirnaty for kids of this age group.
The FDA authorizes Pfizer’s COVID-19 vaccine for children ages 5 to 11.
Earnings ESP: Pfizer’s Earnings ESP is +2.25% as the Most Accurate Estimate of $1.11 per share is pegged higher than the Zacks Consensus Estimate of $1.08 per share.
Pfizer Long (Buy)
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