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Comirnaty carried Pfizer's third quarter sales to $24.1bn(Source:Shutterstock)

 

While Pfizer Inc. continues to reap huge revenues from its BioNTech SE-partnered COVID-19 vaccine Comirnaty, prompting another increase in sales guidance, without that windfall the company’s third quarter performance was muted, with some key product lines showing weakness. The company highlighted pipeline programs that could be the next set of growth drivers, albeit there have been some speedbumps in its gene therapy programs.

The drug maker announced its third quarter sales and earnings on 2 November, reporting revenues of $24.1bn, a 130% increase over the comparable period of 2020. Of that figure, $13bn came from sales of Comirnaty, but even when excluding the mRNA vaccine revenues saw a 7% increase. The company expects the vaccine to have sales of $36bn in 2021, compared with the $33.5bn it forecast when releasing its second quarter earnings. (Pfizer On Boosters Kids And Prospects For A LongTerm COVID19 Business) Comirnaty revenues in 2022 are expected to reach $29bn.

In a same-day note, Evercore ISI analyst Umer Raffat explained the updated guidance for Comirnaty sales reflected contracts signed since mid-July, while the new guidance incorporates it.

“In other words, all the concerns put to bed for 2021 [numbers],” Raffat said.

Comirnaty Provides A Boost

The earnings announcement closely follows the US Food and Drug Administration’s decision 29 October to grant emergency use authorization to Comirnaty for use in children aged 5-11, while also extending the review of Moderna, Inc.’s mRNA-1273 for use in the 12-17 age group due to concerns about myocarditis. Comirnaty has had an EUA for ages 12-15 since May. (With Pfizer EUA For 511 And Moderna Delay For Adolescents US FDA Walks Myocarditis Tightrope) Pfizer and BioNTech also plan to seek full FDA approval for a third booster shot of Comirnaty, currently administered to high-risk populations under an EUA. (Coronavirus Update Gates Foundation To Give $120m For Molnupiravir Access)

The additional EUAs have translated into increased market share for Pfizer/BioNTech. Pfizer CEO Albert Bourla told the earnings call that in the US, the four-week average market share for Comirnaty increased from about 56% in April to 74% as of 31 October, while increasing from 70% to 80% in the EU during the same period.

“These market share increases are primarily the result of our booster being the first to receive emergency use authorization and our two-dose series being preferred by some countries around the world for use in certain younger populations,” Bourla said.

To date, he added, the company has shipped 2 billion doses to 152 countries or territories, and 75% of revenues from the vaccine come from outside the US. The company has produced 2.6 billion doses and remains on track to produce 3 billion in total, with 1 billion going to middle- and low-income countries. The US has purchased 600 million doses, including 115 million for pediatric use, which Bourla said would be enough to vaccinate every child in the country. The pediatric doses include 50 million that the companies announced they would provide to the government on 28 October.

Beyond the vaccine, Pfizer also reported progress on its development of COVID-19 therapeutics, intravenous and oral protease inhibitors that it is testing in Phase II/III studies. In September, the company initiated the EPIC-PEP study of the oral drug PF-07321332, co-administered with low-dose ritonavir as post-exposure prophylaxis among participants sharing households with infected people. The EPIC program also includes a study in infected high-risk patients that started in July and one in infected standard-risk patients that started in August.

Merck & Co., Inc. and Ridgeback Biotherapeutics LP made headlines earlier in October when they unveiled positive Phase III data for their oral COVID-19 therapeutic, molnupiravir, which will come up for an EUA decision by the FDA in December and could garner the companies $5bn-$7bn through 2022. (Merck Forecasts Global Molnupiravir Revenues Of $5bn-$7bn Through 2022)

Pfizer chief scientific officer Mikael Dolsten said the company remains optimistic about its protease inhibitor program and is awaiting data for the high-risk EPIC study before the end of the year.

“The standard-risk – as you heard, we are the only one running such a study for an oral drug,” Dolsten said. “It’s really a unique opportunity, and it will be a growing need for those who do not get repeat vaccinations.”

Dolsten touted its protease inhibitors as having a potential safety advantage relative to polymerase inhibitors, which includes both molnupiravir – more specifically a ribonucleoside – as well as Gilead Sciences, Inc.’s Veklury (remdesivir). However, the Phase III molnupiravir study showed a comparable adverse event rate between the treatment and placebo arms, with fewer patients in the molnupiravir discontinuing treatment due to adverse events.

“And I think for the household study, a protease inhibitor, with its well-known safety, is really intriguing,” he added. “As you know, protease inhibitors of this kind do not possess a risk for the type of side effects that’s seen sometimes with polymerase inhibitors and require longer follow-ups before you know about their potential impact.”

R&D Progress, With Some Speedbumps

Pfizer is looking forward to results from several clinical programs in 2022, including its Phase III study of adult and maternal vaccine candidates for respiratory syncytial virus; proof-of-concept data for a messenger RNA flu vaccine candidate and its Valneva SE-partnered Lyme disease candidate; potential pivotal Phase II data for the BCMA-targeting bispecific antibody elranatamab in relapsed/refractory multiple myeloma; and Phase III results for Talzenna (talazoparib) and Xtandi (enzalutamide) in first-line metastatic castration-resistant prostate cancer.

It is also awaiting an FDA decision for abrocitinib, its new JAK inhibitor for moderate to severe atopic dermatitis in patients 12 and older, which has already received approval – under the name Cibinqo – in the UK and Japan and a positive opinion in adults from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

That comes amid an FDA review of JAK inhibitors used in autoimmune diseases, based on the agency’s review of the ORAL Surveillance trial of Pfizer’s Xeljanz (tofacitinib). (Keeping Track US FDA Is Approving JAK Inhibitors Again Starting With Incytes Opzelura Seagens Tivdak Cleared)

“Overall, we remain confident in the importance of the JAK inhibitor class for appropriate patients with inflammatory diseases, and we are pursuing a variety of options for advancing additional JAK inhibitor assets within our portfolio,” Bourla told the call.

“In terms of Xeljanz in its currently approved indications in the US, we believe that Xeljanz prescribing behavior will adjust in the coming months based on the FDA’s update, resulting in an initial correction in the short term,” Bourla said. “But based on the trends we have observed and the broad application of Xeljanz across its approved indications, we believe Xeljanz has the potential to return to growth again once a final US label is issued, and physicians have adjusted their prescribing habits accordingly as we go into 2022 and beyond.” Xeljanz sales declined 7% in the third quarter. (See table below for detailed product sales.)

Pfizer reported that it temporarily and voluntarily paused screening and dosing in the Phase III study of giroctocogene fitelparvovec, the Factor VIII (FVIII) gene therapy for hemophilia A that it is developing with Sangamo Therapeutics, Inc. The companies plan to amend the study protocol after observing FVIII levels greater than 150% in some participants, which increases the risk of thrombotic events. However, they have not observed any such events, and some patients have received anticoagulants to reduce the risk.

“We are committed to resuming dosing as quickly as possible once a protocol amendment, which is intended to provide guidelines for clinical management of elevated Factor VIII levels, is implemented,” Dolsten said.

Separately, and citing interactions with the FDA, Pfizer no longer plans to conduct an interim analysis of Phase III data for its hemophilia A and B gene therapy programs, due to the expectation that pivotal data readouts will be based on full analyses of at least 50 patients in the hemophilia A program and 40 in the hemophilia B program. The company anticipates a readout from the hemophilia B program in the first quarter of 2023, while for hemophilia A it is working to “evaluate the impact of both the FDA feedback, as well as the protocol amendment, on timelines and will share an update at the appropriate time.”

“This will push out the timing of readouts for those trials compared to our previous expectations,” Dolsten said.

In its Phase III ambulatory Duchenne muscular dystrophy (DMD) study, Pfizer has proposed a protocol change that would exclude patients with any mutation affecting exons 9 through 13 or a deletion affecting both exons 29 and 30, mutations that represent less than 15% of DMD patients. The decision follows company reports of muscle weakness, presumed myositis, in some cases with myocarditis, in three patients. The patients all improved within weeks and were discharged from the hospital, but the data monitoring committee confirmed that immunologic assessments performed in the study support the hypothesis that the changes resulted from an immune response against the mini-dystrophin protein, a reaction that is a risk to any gene-replacement therapy.

“We recognize the devastating impact that DMD has on these boys and their families and plan to include patients with some of these excluded mutations in future studies,” Dolsten said, adding that a few sites have resumed activity and nearly all sites outside the US will have restarted clinical activity by the end of the month.

Weakness In Some Products

In a 2 November note, Mizuho Securities analyst Vamil Divan said results for the company’s business outside of Comirnaty were mixed, with most other key products coming in close to or slightly below expectations.

“Quarterly results were solid but mix was not great,” Bernstein analyst Ronny Gal said in a same-day note. “While the company posted strong Covid vaccine numbers, the base business underperformed versus expectations (driven by weakness in Prevnar, Ibrance, Vyndaqel).”

US sales for the Prevnar vaccines – Prevnar 13 and Prevnar 20 – fell 2%, mainly due to a 36% decline in use of Prevnar 13 stemming from prioritization of COVID-19 vaccinations in adults and a later start to the flu season. It also took a hit because in 2019 Prevnar 13 lost the endorsement of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for routine use in adults, though in mid-October ACIP voted to recommend Prevnar 20 for routine use in adults aged 65 and older or 19-64 with certain high-risk conditions, without the need to follow that with PPCV-23 vaccination.



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