Pfizer 2023: Past the post-COVID horizon

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Comirnaty, Pfizer

Pfizer’s mRNA vaccine, Comirnaty, was the company’s highest-selling product once again, but leaders are looking to the Seagen acquisition for future growth.

By Christiane Truelove • [email protected]

Pfizer

Pfizer

66 Hudson Boulevard East, New York, NY 10001-2192

202-733-2323 • pfizer.com

 

Financial Performance 
  2022 2021 1H 2023 1H 2022
Revenue $100,330 $81,288 $31,015 $53,402
Net income $31,372 $21,979 $7,870 $17,769
Diluted EPS $5.47 $3.85 $1.38 $3.10
R&D Expense $11,428 $10,360 $5,153 $5,116

All figures are in millions of dollars, except EPS.

 

Best-selling products

All sales are in millions of dollars.

2022 sales

  • Comirnaty $37,806 
  • Paxlovid $18,933 
  • Eliquis $6,480 
  • Prevnar family $6,337 
  • Ibrance $5,120 
  • Vyndaqel $2,447 
  • Xeljanz $1,796 
  • Xtandi $1,198 
  • Enbrel $1,003 
  • Inlyta $1,003 
  • Sulperazon $786 
  • Bosulif $575 
  • Zirabev $562
  • Inflectra $532

1H 2023

  • Comirnaty $4,552 
  • Paxlovid $4,212 
  • Eliquis $3,636 
  • Prevnar family $2,981 
  • Ibrance $2,391 
  • Vyndaqel $1,468 
  • Xeljanz $706 
  • Xtandi $564 
  • Inlyta $521 
  • Sulperazon $497 
  • Enbrel $419 
  • Nurtec ODT $414 
  • Bosulif $304 
  • Inflectra $252

Outcomes Creativity Index Score: 9

  • Manny Awards — 2
  • Cannes Lions — N/A
  • Clio Health — N/A
  • Creative Floor Awards — N/A
  • LIA: Pharma/Health & Wellness – 3
  • MM+M Awards — 4
  • One Show — N/A

 

Albert Bourla

CEO Alfred Bourla

According to CEO Albert Bourla, 2022 was an outstanding year for the company, “with our key growth drivers providing evidence of the depth and breadth of our portfolio.

“With the unprecedented wave of innovations expected to emerge from our scientific pipeline in the near term, potential business development activities, our increased investments in our R&D and commercial capabilities, and additional potential new products and indications coming in the second half of the decade, we believe we can build on the momentum we have created to deliver life-changing innovations to even more patients around the world.”

A little more than four years ago, Pfizer unveiled a new corporate mission and slogan: “Breakthroughs that change patients’ lives.”

“Pfizer has always had a noble purpose rooted in our commitment to patients, but we wanted to make our purpose more memorable, more inspiring and, most important, more actionable,” Bourla states. “I am happy to say that in the 50 months since then, Pfizer’s more than 80,000 colleagues around the world have lived this purpose every day. They have pursued impactful breakthroughs with the goal of dramatically changing the lives of patients for the better. As a result of this unwavering commitment to innovation and patients, 2022 was a simply remarkable year for our company on multiple fronts.”

Among the company’s achievements were receiving eight key regulatory approvals, completing 13 regulatory submissions, and initiating 10 pivotal study starts.

“We maintained our industry-leading clinical success rates and further improved our cycle times, which already were among the industry’s best, and we did all of this while maintaining our high standards of quality, safety, and scientific rigor,” Bourla says.

Pfizer completed four acquisitions last year – Arena Pharmaceuticals, Biohaven Pharmaceuticals, Global Blood Therapeutics, and ReViral – which Bourla states have further strengthened both the pipeline and the company’s current portfolio of innovative offerings.

In March, Pfizer revealed plans to acquire Seagen Inc., through a definitive merger agreement, for $43 billion.

“Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise,” Bourla says. “Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer’s position in this important space and contribute meaningfully to the achievement of Pfizer’s near- and long-term financial goals.”

Seagen expects to generate approximately $2.2 billion of revenue in 2023, representing 12 percent year-over-year growth, from its four in-line medicines, royalties, and collaboration and license agreements, according to executives. “When combining the expected strong growth trajectories for these medicines with candidates that could emerge from Seagen’s pipeline, subject to clinical trial and regulatory success, Pfizer believes Seagen could contribute more than $10 billion in risk-adjusted revenues in 2030, with potential significant growth beyond 2030.”

Pfizer is financing the transaction substantially through $31 billion of new, long-term debt, and the balance from a combination of short-term financing and existing cash. The transaction is expected to be neutral to slightly accretive to adjusted diluted earnings per share in the third to fourth full year post close. Executives say Pfizer expects to achieve nearly $1 billion in cost efficiencies in the third full year after the completion of the transaction.

The company also managed to hold its leadership in the COVID-19 area. As of February 22, 2023, Pfizer held a 64 percent  market share of bivalent boosters in the United States, “a significant expansion on the booster share leadership position that we already held before the bivalent booster launch – and our bivalent booster market shares are even higher in several key markets outside the U.S.,” Bourla stated.

“We believe our best-in-class mRNA capability, coupled with our proven and reliable manufacturing network, will ensure we are well positioned to continue to adapt our vaccine as needed and get it to people around the world.”

During the year, the company  launched An Accord for a Healthier World. According to Bourla, through this initiative, Pfizer now offers on a not-for-profit basis the full portfolio of medicines and vaccines for which it has global rights to 45 lower-income countries.

Another key element of the Accord is collaborating with global health leaders to make improvements in diagnosis, education, infrastructure, and innovative financing. The first shipments of Pfizer products under the program arrived in Rwanda in September 2022, and the company is working with that country and other governments – including in Ghana, Malawi, and Senegal – on future deliveries, as well as health system improvements.

In the United States, through  its Multicultural Health Equity Collective, Pfizer convened more than 100 health equity leaders from across the country “to engage in candid conversations about the drivers and impact of systemic racism on healthcare,” Bourla says. “The dialogue highlighted creative solutions that are already starting to reduce health disparities in local communities across the country.”

Financial & product performance

Comirnaty, Pfizer

Comirnaty comprised 38 percent of Pfizer sales in 2022.

In 2022, Pfizer exceeded $100 billion in revenue for the first time in its 174-year history. The company reported revenue of $100.33 billion, 23.4 percent more than in 2021. Net income was $31.37 billion, a 42.7 percent increase, and diluted earnings per share were $5.47 versus $3.85.

Revenue in the first half of 2023 was $31.02 billion compared with $53.4 billion in the same period last year. Net income was $7.87 billion compared with $17.77 billion, and diluted earnings per share were $1.38 versus $3.10.

Sales were driven in 2022 by 10 products each making more than $1 billion, constituting 82 percent of Pfizer’s revenue.

No. 1 in sales once again was the COVID-19 vaccine Comirnaty, at $37.81 billion, 2.8 percent more than in 2021. The vaccine comprised 38 percent of Pfizer sales in 2022.

Paxlovid, Pfizer

Sales of Paxlovid will continue to be affected by lower demand.

N0. 2 in sales was the COVID-19 antiviral Paxlovid, which generated $18.93 billion compared with $76 million in 2021. Sales of the product were 19 percent of the company’s revenue in 2022.

During the first half of 2023, both of these products remained the top two in sales for the company, but did not make nearly as much as they did last year due to much lower demand for both products as the COVID-19 pandemic lessened its grip.  Sales of Comirnaty during the first six months were $4.55 billion compared with $26.08 billion. And sales of Paxlovid were $4.21 billion versus $9.59 billion in first-half 2021.

For full-year 2023, Pfizer expects Comirnaty revenue of about $13.5 billion, down 64 percent from 2022 results. Paxlovid revenue is expected to be about $8 billion, down 58 percent from 2022 results. “In contrast to previous years, guidance for both products is no longer based primarily on expected deliveries under existing signed or committed supply contracts, but now also includes, among other things, an anticipated transition to traditional commercial markets in the U.S. in the second half of 2023,” executives say.

The lower sales of these products contributed to the company’s lower revenue in the first half of the year, but executives say other products will help generate sales in the latter six months. “Despite a few near-term individual product revenue challenges, we believe the company is well positioned for accelerated growth of our non-COVID products in the second half of 2023,” says David Denton, chief financial officer. “The COVID environment continues to evolve rapidly and remains highly unpredictable. In spite of this uncertainty, the company is maintaining its focus on ensuring successful fall vaccinations during the respiratory infection season.”

In September, Pfizer and partner BioNTech received FDA approval for the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. This season’s vaccine is indicated as a single dose for most individuals 5 years of age and older.

Eliquis

At $6.48 billion, Eliquis was Pfizer’s third highest-selling product in 2022.

Next in 2022 sales at $6.48 billion was the oral anticoagulant Eliquis. Sales grew 8.5 percent from 2021. Growth driven primarily by continued oral anti-coagulant adoption and market share gains in non-valvular atrial fibrillation in the U.S. and certain markets in Europe, as well as favorable changes in channel mix in the U.S., partially offset by the non-recurrence of an $80 million favorable adjustment related to the Medicare “coverage gap” provision recorded in the first quarter of 2021 in the United States, as well as declines in certain emerging markets.

For first-half 2023, sales were $3.64 billion, a  2.8 percent increase, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the United States and certain markets in Europe.

No. 4 in  2022 sales was the Prevnar family of vaccines, which generated $6.34 billion, an increase of 20.2 percent. Executives say growth was primarily driven by the adult indications in the United States due to  strong patient demand following the launch of Prevnar 20 for the eligible adult population. In the first half of this year, sales were $2.98 billion, about the same as in the period last year.

Ibrance

Ibrance’s 2022  sales were $5.12 billion, 5.8 percent less than in 2021.

The lung cancer drug Ibrance generated sales of $5.12 billion, 5.8 percent less than in 2021. Executives say global declines were primarily driven by prior-year clinical trial purchases internationally, planned price decreases that recently went into effect in international developed markets, and continued increase in the proportion of patients accessing Ibrance through the U.S. Patient Assistance Program. For the first six months of 2023, sales were $2.39 billion, 6.5 percent less than in first-half 2022, mostly due to lower demand globally due to competitive pressure, lower clinical trial purchases internationally, and planned price decreases in certain international developed markets.

Sales of Vyndaqel were another bright spot for Pfizer in 2022. The drug, for treating cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), had sales of $2.45 billion, an increase of 21.4 percent. Growth was largely from continued strong uptake of the ATTR-CM indication, primarily in developed Europe and the United States, executives say. During the first half of 2023, sales were $1.47 billion, an increase largely driven by continued strong uptake of the ATTR-CM indication, primarily in the United States and developed Europe.

Sales of the rheumatoid arthritis drug Xeljanz were 26.8 percent less than in the previous year, at $1.8 billion. Global declines were driven primarily by decreased prescription volumes globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as declines in net price due to unfavorable change in channel mix in the United States. First-half 2023 sales were $706 million, down 12 percent due to decreased prescription volumes globally from ongoing shifts in prescribing patterns related to label changes.

The prostate cancer drug Xtandi had sales of $1.19 billion in 2022, about the same as in 2021. During the first six months of 2023, sales were $564 million compared with first-half 2022’s $558 million.

The rheumatoid arthritis drug Enbrel continued to face biosimilar erosion in 2022, with sales going down 15.4 percent to slightly more than $1 billion. First-half 2023 sales were $419 million, 22 percent less than in the same period last year.

The kidney cancer drug Inlyta generated slightly more than $1 billion in sales in 2023, about the same as in 2021. In the first six months of 2023, sales were $521 million, 1.1 percent more than in the same period last year. Executives say this growth primarily reflects continued strong performance in emerging markets and the United States, driven by the adoption of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Sulperazon, for the systemic treatment of infections, exhibited strong 2022 sales growth, reaching $786 million, 15 percent more than in the previous year. First-half sales were $497 million, an increase of 18.3 percent. Growth was attributed to increased revenue in China during the first quarter.

Bosulif, for Philadelphia-positive chronic myelogenous leukemia, had 2022 sales of $575 million, an increase of 6.5 percent. The drug recorded first-half 2023 sales of $304 million, 7 percent more than in the same period last year.

Pfizer’s oncology drug Zirabev, a biosimilar of bevacizumab, was one of the company’s fast-growing products last year, achieving $562 million in sales, a 26.6 percent increase. Sales in the first half of this year declined 17.8 percent to $235 million compared with the same period last year. 

Sales of the Crohn’s disease drug Inflectra declined in 2022, from $657 million to $532 million. In the first half of 2023 sales were $252 million, 7.4 percent less than in the first six months of 2022. Executives attribute this decrease to a lower net price in the United States as a result of unfavorable changes in channel mix.

Progress in the pipeline

Last year, Pfizer spent $11.43 billion for research and development, 10.3 percent more than in 2021. R&D expenses for 2023 look to be on par with the previous year, as the company reported spending $5.15 billion in the first six months of the year compared with $5.12 billion in first-half 2022. Pfizer has five areas of research focus: rare disease, internal medicine, inflammation and immunology, vaccines, oncology, and anti-infectives. In July 2023, Pfizer made changes to its executive leadership team to further advance its pipeline, with an emphasis on oncology. Chris Boshoff, M.D., Ph.D., joined as chief oncology research and development officer and executive VP, reporting to Bourla.

“Under his leadership, Pfizer will continue to invest in its fight against cancer, and Dr. Boshoff will be the single point of accountability for the entire oncology pipeline – from discovery to early- and late-phase clinical development,” executives say.

Leaders say the proposed combination with Seagen would double Pfizer’s early-stage oncology clinical pipeline.

“Over the past decade we’ve taken bold new approaches to translating scientific research into effective medicines for people living with cancer, and we have pioneered several breakthroughs in breast cancer, genitourinary cancer, hematological malignancies, and precision medicine,” Boshoff says. “The addition of Seagen’s world-
leading ADC technology will position us at the forefront of innovative cancer care, and strongly complements our existing portfolio across both solid tumors and hematologic malignancies. We believe the combination of our teams, and respective areas of strength and global footprints will allow us to realize Seagen’s potential and advance even more potential breakthroughs to patients with cancer.”

Mikael Dolsten, M.D., Ph.D., chief scientific officer, president, Pfizer Research & Development, has expanded his role to lead all discovery, early- and late-stage clinical development for all non-oncology therapeutic areas, including vaccines, inflammation and immunology, internal medicine, and infectious diseases as well as non-malignant hematology and rare neuromuscular diseases.

As a result of these moves, William Pao, M.D., Ph.D., chief development officer and executive VP, will be leaving Pfizer to pursue new opportunities outside the company.

In other advances made in its oncology pipeline, Pfizer in June announced the first detailed results from the Phase II PHAROS study, which is evaluating the efficacy and safety of Braftovi given in combination with Mektovi to patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). FDA is reviewing the company’s supplemental New Drug Applications (sNDAs) for Braftovi + Mektovi for patients with metastatic NSCLC, with a PDUFA goal date for a decision expected by the FDA in fourth quarter 2023.

Also in June, FDA approved Talzenna and Litfulo. Talzenna is an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). Litfulo is a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata.

In the area of multiple myeloma, Pfizer shared updated data in June for elranatamab (PF-06863135), an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb). FDA granted priority review for the company’s Biologics License Application.

As the urgency of addressing COVID-19 fades, Pfizer has turned its attention to vaccines for other potentially fatal respiratory diseases. In May 2023, Pfizer announced the FDA approved Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. Abrysvo has been recommended for use in adults 60 years of age and older.

In July 2023, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for RSVpreF for older adults. The vaccine will also be marketed by the trade name Abrysvo in the European Union (EU). In August, the company stated that the European Commission (EC) granted marketing authorization for the vaccine, to help protect both infants through maternal immunization and older adults.

In June 2023, Pfizer presented for the first time an analysis of initial vaccine efficacy data for mid-RSV season two in the Northern Hemisphere from the ongoing pivotal Phase III trial in older adults, as well as presented at the CDC’s Advisory Committee on Immunization Practices (ACIP) June meeting positive top-line results from a Phase III study that support the co-
administration of Abrysvo with flu vaccine in older adults.

Prevnar, Pfizer

The Prevnar vaccine family continues growth with 2022 sales of $6.34 billion.

Also in June, Pfizer announced the CDC’s ACIP unanimously voted to recommend Prevnar 20 for routine vaccination for all children under two years of age, for eligible children aged 2-18 years with certain underlying medical conditions, and a catch-up dose for children with an incomplete pneumococcal conjugate vaccine vaccination status.

In July, Pfizer announced data from a Phase II study investigating GBS6 (PF-06760805), a hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate being developed for maternal administration to protect infants against invasive GBS disease. In stage two of the three-part study, which enrolled 360 healthy pregnant individuals, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were efficiently transferred to infants at ratios of ~0.4-1.3 depending on GBS6 group. GBS6 was granted PRIME designation by the EMA’s CHMP and has received Breakthrough Therapy Designation from the FDA.

In May, Pfizer announced the FDA approved Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid has been available in the United States since December 2021 under Emergency Use Authorization (EUA). The U.S. government will continue to oversee the distribution of Paxlovid, but Pfizer expects a transition to traditional commercial markets in the second half of the year.

Expanding the company’s portfolio of migraine drugs, FDA in March approved Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. The drug was anticipated to be available in pharmacies in July 2023.

“The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” says Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer. “Zavzpret underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives. Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”

In some good news in the struggle against antibiotic resistance, Pfizer announced positive Phase III results from the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of the novel investigational antibiotic combination aztreonam-
avibactam
(ATM-AVI) in treating serious bacterial infections due to Gram-negative bacteria, including metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens. Data from these studies are expected to form the basis for planned regulatory filings in the European Union, United Kingdom, China, and the United States in the second half of 2023. Pfizer holds the global rights to commercialize ATM-AVI outside of the United States and Canada, where the rights are held by its development partner, AbbVie (see profile on page 19).

Pfizer is trying to get its own entry in the market dominated by Novo Nordisk’s Wegovy (see profile on page 57). In June 2023, Pfizer announced it would continue to advance its oral glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate danuglipron toward late-stage development for the potential treatment of adults with obesity and Type 2 diabetes mellitus, subject to results from the ongoing Phase II trial; and to discontinue the clinical development of a second GLP-1RA candidate lotiglipron (PF-07081532). The company expects to finalize plans for the danuglipron late-stage program by the end of 2023 and also is developing a once-daily modified release version.

Pfizer says FDA in June accepted for review the company’s BLA for fidanacogene elaparvovec for the treatment of adults with hemophilia B and that the European MAA also has been accepted and is under review by the EMA. Fidanacogene elaparvovec is a novel investigational gene therapy that contains a bio-engineered adeno-associated virus capsid and a high-activity variant of human coagulation Factor IX gene. The FDA has set a PDUFA goal date in the second quarter of 2024.

In May 2023, executives say the pivotal Phase III BASIS clinical trial evaluating marstacimab met its primary endpoints, having demonstrated statistically significant and clinically meaningful effects. Marstacimab is a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B for people with and without inhibitors to Factor VIII or Factor IX. The BASIS trial demonstrated that prophylactic treatment with marstacimab resulted in a statistically significant and clinically relevant effect on annualized bleeding rate in people living with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.

Pfizer revealed in February that FDA approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib), expanding its indication to include adolescents between 12 to less than 18 years old with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The drug was previously approved only for the treatment of adults 18 years and older.

This year, Pfizer also has continued to expand its R&D partnerships beyond BioNTech. In July, Pfizer and Flagship Pioneering Inc. announced the companies have partnered to create a new pipeline of innovative medicines. Under the terms of the novel agreement, Flagship and Pfizer will each invest $50 million upfront to explore opportunities to develop 10 single-asset programs by leveraging Flagship’s ecosystem of more than 40 human health companies and multiple biotechnology platforms. Pfizer will fund and have an option to acquire each selected development program. Flagship and its bioplatform companies will be eligible to receive up to $700 million in milestones and royalties for each successfully commercialized program.

In May 2023, Pfizer and Thermo Fisher Scientific Inc. announced they entered into a collaboration agreement to help increase local access for next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East, and Asia where advanced genomic testing has previously been limited or unavailable.

Under the agreement, Pfizer will explore ways to enable affordable patient access for NGS testing in these cancers and work to raise healthcare provider awareness regarding the benefits of advanced testing.