Pfizer lifts outlook again as COVID-19 vaccine projected to rack up $36 billion

Headline results for the third quarter:

  • Revenue: $24.1 billion (forecasts of $22.2 billion), up 134%
  • Profit: $8.1 billion, versus $1.5 billion

Note: All changes are versus the prior-year period unless otherwise stated

What the company said:

"I continue to be very pleased with the way our business is performing in 2021, both including and excluding the significant contributions of Comirnaty to our results," remarked chief financial officer Frank D'Amelio.

CEO Albert Bourla noted that more than 75% of the revenues recorded for its BioNTech-partnered COVID-19 vaccine up through the third quarter "have come from supplying countries outside the US, and we remain on track to achieve our goal of delivering at least 2 billion doses to low- and middle-income countries by the end of 2022."

Other results:

  • Vaccine sales: $14.6 billion, versus $1.7 billion, although revenues not counting Comirnaty were up a more modest 7%
    • Comirnaty: $13 billion, up from $7.8 billion in the second quarter
    • Prevnar 13/Prevenar 13: $1.4 billion, down 6%, negatively impacted by a 36% decline in the adult indication in the US, as primary and booster vaccination campaigns for COVID-19 are prioritised
  • Oncology product sales: $3.1 billion, up 12%
    • Ibrance: $1.4 billion, up 2%, driven by accelerating demand as delays in diagnosis and treatment starts caused by COVID-19 show signs of recovery across several international markets
    • Xtandi alliance revenue: $309 million, up 16%, driven by "strong demand" across metastatic and non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer
    • Inlyta: $256 million, up 31%, reflecting continued adoption in the US and Europe of combinations with certain checkpoint inhibitors for first-line renal cell carcinoma
  • Eliquis alliance revenue and direct sales: $1.3 billion, up 21%, driven primarily by increased adoption in non-valvular atrial fibrillation
  • Xeljanz: $610 million, down 7%, hit by a recent FDA decision to slap stricter warnings on JAK inhibitors following a safety review, although Pfizer sees a "potential return to growth once the final US label is issued and physicians' prescribing habits adjust"
  • Vyndaqel/Vyndamax: $501 million, up 43%, boosted by "strong uptake" of the transthyretin amyloid cardiomyopathy indication in the US, Europe and Japan
  • Enbrel (outside the US and Canada): $283 million, down 12%, as a result of continued biosimilar competition
  • Chantix/Champix: $7 million, down 97%, hit by a voluntary recall across multiple markets and the global pause in shipments due to elevated levels of N-nitroso-varenicline, with Pfizer noting the "ultimate timing for resolution…may vary by country"
  • Total biosimilars: $575 million, up 36%, mainly due to recent oncology monoclonal antibody biosimilar launches of Ruxience, Zirabev and Trazimera, as well as continued growth from Retacrit in the US

Looking ahead:

Spurred by new supply agreements, including for booster shots and doses for younger children, Pfizer now expects revenue this year of between $81 billion and $82 billion, lifted from an earlier range of $78 billion to $80 billion. Meanwhile, earnings per share are now forecast to be between $4.13 and $4.18, raised from a prior predicted range of $3.95 to $4.05.

The company also now expects sales of roughly $36 billion from Comirnaty this year, reflecting the delivery of 2.3 billion doses – out of the roughly 3 billion it plans to make by year-end. At its last quarterly earnings call, Pfizer was predicting the vaccine would generate $33.5 billion in 2021. However, the company says Comirnaty revenue is expected to taper in 2022 to about $29 billion, with about 1.7 billion doses to be delivered, although the projection is still higher than Wall Street's average view of $23 billion.

According to D'Amelio, Pfizer and BioNTech might still get additional orders for next year, and they anticipate being able to make up to 4 billion doses in 2022. "We already now are preparing for revaccination when the third boost immunity may start to fade, possibly after year, which we think would be the type of data to generate to support more of an annual vaccination similar to flu," added chief scientific officer Mikael Dolsten.

What analysts said:

Analyst Sam Fazeli of Bloomberg Intelligence said "the 24% [earnings per share] and 6% sales beats reflect our expectations, but the real question is whether consensus' $23 billion for 2022 vaccine sales is too low." He noted that the "raised guidance reflects the outperformance, though higher R&D costs partly mitigate the boost to earnings."

Pipeline update:

Meanwhile, Bourla disclosed that Pfizer has granted an exclusive license to the TYK2/JAK1 inhibitor brepocitinib (PF-06700841) and the TYK2 inhibitor PF-06826647 to a new company formed in collaboration with an unnamed partner "that has a proven track record in late-stage inflammation and immunology drug development." Both compounds are in mid-stage testing for a variety of autoimmune/auto-inflammatory indications.

The new company will direct all future development decisions, while Pfizer will have a 25% stake and retain certain ex-US commercial rights for brepocitinib and PF-06826647. "This transaction will enable the allocation of resources to advance development of [both drugs], while allowing Pfizer to focus on diversifying its pipeline," Bourla said, adding that "overall, we remain confident in the importance of the JAK inhibitor class for appropriate patients with inflammatory diseases."

Also cut from the company's pipeline were early-stage assets PF-06952229, which is a TGFBR1 inhibitor under development as a potential cancer treatment, and the CDK4/6 inhibitor PF-06842874, which was being evaluated for pulmonary arterial hypertension.

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