Pfizer Reports Fourth-Quarter and Full-Year 2021 Results
- Full-Year 2021 Revenues of $81.3 Billion, Reflecting 92% Operational Growth; Excluding Contributions from Comirnaty(1) and Paxlovid, Revenues Grew 6% Operationally to $44.4 Billion
- Fourth-Quarter 2021 Revenues of $23.8 Billion, Reflecting 106% Operational Growth; Excluding Contributions from Comirnaty(1) and Paxlovid, Revenues Declined 2% Operationally Driven Primarily by the Impact of Fewer Selling Days Compared to the Prior-Year Quarter
- Full-Year 2021 Reported Diluted EPS(2) of $3.85, Adjusted Diluted EPS(3) of $4.42; Fourth-Quarter 2021 Reported Diluted EPS(2) of $0.59, Adjusted Diluted EPS(3) of $1.08
- Provides Full-Year 2022 Record-High Guidance(4) for Revenues of $98.0 to $102.0 Billion and Adjusted Diluted EPS(3) of $6.35 to $6.55, Reflecting 23% and 46% Year-Over-Year Growth at the Midpoints, Respectively
- Raises 2022 Revenue Guidance for Comirnaty(1) to Approximately $32 Billion, Reflecting Doses Expected to be Delivered Under Supply Contracts Signed as of Late-January
- Issues Initial 2022 Revenue Guidance for Paxlovid of Approximately $22 Billion, Reflecting Treatment Courses Expected to be Delivered Primarily Under Supply Contracts Signed or Committed as of Late-January
- Provides Updates and New Data for Select Clinical Programs Spanning Vaccines, Hospital, Oncology, Rare Disease and Internal Medicine on Analyst Conference Call
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) reported strong financial results for fourth-quarter and full-year 2021 and provided 2022 total company financial guidance(4). In addition, Pfizer raised its previous 2022 revenue guidance for Comirnaty(1), the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and provided for the first time 2022 revenue guidance for its oral COVID-19 treatment, Paxlovid.
The fourth-quarter 2021 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found on the Pfizer website.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “In the early days of the COVID-19 pandemic, we committed to use all of the resources and expertise we had at our disposal to help protect populations globally against this deadly virus, as well as to offer treatments to help avoid the worst outcomes when infections do occur. We put billions of dollars of capital on the line in pursuit of those goals, not knowing whether those investments would ever pay off. Now, less than two years since we made that commitment, we are proud to say that we have delivered both the first FDA-authorized vaccine against COVID-19 (with our partner, BioNTech) and the first FDA-authorized oral treatment for COVID-19.”
Dr. Bourla continued: “These successes have not only made a positive difference in the world, but I believe they have fundamentally changed Pfizer and its culture forever. Everywhere I look in the company, I see colleagues who are inspired by what we have achieved to date and filled with determination to be part of the next breakthrough that could change the world for patients in need. As we enter a new year, I look forward to all we will accomplish together.”
Frank D’Amelio, Chief Financial Officer, Executive Vice President, stated: “As I prepare to retire as CFO of Pfizer, I am proud to see that the company is performing better than at any other time during my nearly 15 years here. Today we are issuing guidance for the coming year which, if achieved, would represent the highest level of annual revenues and Adjusted diluted EPS(3) in Pfizer’s long history. In addition, we just concluded a year where we provided tremendous value to society, including to both patients and shareholders. In 2021, we exceeded our goal of manufacturing 3 billion doses of Comirnaty(1), a monumental and unprecedented achievement by our Global Supply colleagues. Finally, we have prudently deployed our capital through multiple business development transactions in recent months to advance our strategies, always with an eye toward bolstering growth in the latter half of this decade and beyond. I have never been more confident in the future of Pfizer.”
Results for the fourth quarter and full-year 2021 and 2020(5) are summarized below.
OVERALL RESULTS
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| ($ in millions, except | Fourth-Quarter |
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| Full-Year | ||||
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| 2021 | 2020 | Change |
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| 2021 | 2020 | Change |
| Revenues | $ 23,838 | $ 11,634 | 105% |
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| $ 81,288 | $ 41,651 | 95% |
| Reported Net Income(2) | 3,393 | 847 | * |
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| 21,979 | 9,159 | * |
| Reported Diluted EPS(2) | 0.59 | 0.15 | * |
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| 3.85 | 1.63 | * |
| Adjusted Income(3) | 6,239 | 2,434 | 156% |
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| 25,236 | 12,727 | 98% |
| Adjusted Diluted EPS(3) | 1.08 | 0.43 | 152% |
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| 4.42 | 2.26 | 96% |
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* Indicates calculation not meaningful.
REVENUES
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| ($ in millions) | Fourth-Quarter |
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| Full-Year | ||||||
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| 2021 | 2020 | % Change |
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| 2021 | 2020 | % Change | ||
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| Total | Oper. |
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| Total | Oper. | ||||
| Pfizer Biopharmaceuticals | $ 23,456 | $ 11,325 | 107% | 108% |
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| $ 79,557 | $ 40,724 | 95% | 92% |
| Vaccines | 13,914 | 2,001 | * | * |
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| 42,625 | 6,575 | * | * |
| Oncology | 3,242 | 3,024 | 7% | 8% |
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| 12,333 | 10,867 | 13% | 12% |
| Internal Medicine | 2,235 | 2,308 | (3%) | (3%) |
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| 9,329 | 9,003 | 4% | 2% |
| Hospital | 1,884 | 1,861 | 1% | 1% |
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| 7,301 | 6,777 | 8% | 5% |
| Inflammation & Immunology | 1,231 | 1,267 | (3%) | (2%) |
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| 4,431 | 4,567 | (3%) | (4%) |
| Rare Disease | 950 | 865 | 10% | 12% |
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| 3,538 | 2,936 | 20% | 19% |
| Pfizer CentreOne | 382 | 308 | 24% | 25% |
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| 1,731 | 926 | 87% | 84% |
| TOTAL REVENUES | $ 23,838 | $ 11,634 | 105% | 106% |
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| $ 81,288 | $ 41,651 | 95% | 92% |
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* Indicates calculation not meaningful.
Pfizer CentreOne, the company’s contract development and manufacturing organization which previously had been managed within the Hospital therapeutic area, has been moved for all periods presented into a separate operating segment to reflect the company’s revised management structure which went into effect starting in the fourth quarter of 2021. Additionally, revenues and expenses associated with the former Upjohn Business(6) and Pfizer’s former Meridian(6) subsidiary, the manufacturer of EpiPen and other auto-injector products, for all periods presented have been recategorized as discontinued operations and excluded from Adjusted(3) results.
Business development activities completed in 2020 and 2021(5) impacted financial results in the periods presented(6). Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(7).
2022 FINANCIAL GUIDANCE(4)
Pfizer’s 2022 financial guidance is presented below. This guidance includes management’s expectations for contributions from the entire company, including Comirnaty(1) and Paxlovid.
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| Revenues | $98.0 to $102.0 billion |
| Adjusted Cost of Sales(3) as a Percentage of Revenues | 32.2% to 34.2% |
| Adjusted SI&A Expenses(3) | $12.5 to $13.5 billion |
| Adjusted R&D Expenses(3) | $10.5 to $11.5 billion |
| Adjusted Other (Income)/Deductions(3) | Approximately $1.8 billion of income |
| Effective Tax Rate on Adjusted Income(3) | Approximately 16.0% |
| Adjusted Diluted EPS(3) | $6.35 to $6.55 |
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The midpoint of the guidance range for revenues represents 23% growth from 2021 revenues, including an expected $1.1 billion, or 1%, unfavorable impact from changes in foreign exchange rates compared to 2021.
The guidance for 2022 revenues also includes:
- an anticipated $32 billion of revenue for Comirnaty(1), which includes doses expected to be delivered in fiscal 2022(5) under contracts signed as of late-January 2022; and
- an anticipated $22 billion of revenue for Paxlovid, which includes treatment courses expected to be delivered in fiscal 2022(5), primarily relating to supply contracts signed or committed as of late-January 2022.
The midpoint of the guidance range for Adjusted diluted EPS(3) reflects a 46% increase over 2021 actual results, including an expected $0.06, or 1%, unfavorable impact from changes in foreign exchange rates compared to 2021.
Financial guidance for Adjusted diluted EPS(3) is calculated using approximately 5.8 billion weighted average shares outstanding, and assumes no share repurchases in 2022. The expected increase in weighted average shares outstanding compared to 2021 of approximately 100 million shares has an unfavorable impact on 2022 Adjusted diluted EPS(3) of $0.10 at the midpoint of the guidance range.
CAPITAL ALLOCATION
- During full-year 2021, Pfizer paid $8.7 billion of cash dividends, or $1.56 per share of common stock, which represents an increase in dividends per share of 3% compared to full-year 2020.
- No share repurchases were completed in 2021. As of February 8, 2022, Pfizer’s remaining share repurchase authorization is $5.3 billion. Current financial guidance does not reflect any share repurchases in 2022.
- Fourth-quarter 2021 diluted weighted-average shares outstanding used to calculate Reported(2) and Adjusted(3) diluted EPS was 5,768 million shares, an increase of 106 million shares, primarily due to shares issued for employee compensation programs, which resulted in a $0.01 reduction to Reported(2) and a $0.02 reduction to Adjusted(3) diluted EPS compared to the prior-year quarter.
- Full-year 2021 diluted weighted average shares outstanding was 5,708 million shares, an increase of 76 million shares, which resulted in a $0.05 reduction to Reported(2) and a $0.06 reduction to Adjusted(3) diluted EPS compared to full-year 2020.
QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2021 vs. Fourth-Quarter 2020)
Fourth-quarter 2021 revenues totaled $23.8 billion, an increase of $12.2 billion, or 105%, compared to the prior-year quarter, reflecting operational growth of $12.3 billion, or 106%, as well as an unfavorable impact of foreign exchange of $135 million, or 1%.
Compared to the prior-year quarter, fourth-quarter 2021 revenue growth was unfavorably impacted by approximately $500 million, or 4%, as a result of fourth-quarter 2021 having four fewer selling days in the U.S. and four fewer selling days in international markets. This unfavorable impact from fewer domestic and international selling days negatively affected the growth rates of products across the entire portfolio.
Fourth-quarter 2021 operational growth was primarily driven by:
- Comirnaty(1), which contributed $12.5 billion in direct sales and alliance revenues;
- Eliquis globally, up 19% operationally, driven primarily by continued increased adoption in non-valvular atrial fibrillation and oral anti-coagulant market share gains;
- Biosimilars, which grew 30% operationally to $680 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab), as well as growth from Retacrit (epoetin) in the U.S.;
- Vyndaqel/Vyndamax globally, up 34% operationally, primarily driven by continued strong uptake of the transthyretin amyloid cardiomyopathy indication in the U.S. and Japan;
- Pfizer CentreOne, Pfizer’s contract development and manufacturing organization, up 25% operationally, reflecting growth from manufacturing of legacy Upjohn products for Viatris(6) since the close of the Upjohn-Mylan transaction in November 2020 and certain Comirnaty-related manufacturing activities performed on behalf of BioNTech(1);
- Paxlovid, which contributed $76 million in U.S. sales after the U.S. Food and Drug Administration (FDA) authorized the treatment for emergency use(8) in late-December 2021; and
- Xeljanz, up 4% operationally, driven primarily by favorable wholesaler inventory buying patterns in the U.S., as well as growth in the emerging markets from the rheumatoid arthritis indication,
partially offset primarily by lower revenues for:
- Prevnar family (Prevnar/Prevenar 13 & 20) globally, down 25% operationally, driven by:
- a 27% decline in the U.S. primarily due to unfavorable timing of government purchases for the pediatric indication and disruptions to healthcare activity related to COVID-19, including the prioritization of primary and booster vaccination campaigns for COVID-19, as well as the continued impact of a lower remaining unvaccinated eligible adult population, and
- a 24% operational decline outside the U.S. primarily due to the impact of increased adult uptake in the prior-year period from greater vaccine awareness for respiratory illnesses;
- Chantix globally, which continues to be negatively impacted by the ongoing global pause in shipments of Chantix due to the presence of N-nitroso-varenicline above an acceptable level of intake set by various global regulators, the ultimate timing for resolution of which may vary by country, combined with returns of product sold in previous periods;
- Ibrance in the U.S., down 7%, primarily reflecting an increase in the proportion of patients accessing Ibrance through Pfizer’s Patient Assistance Program compared to the prior-year quarter;
- Sutent globally, down 32% operationally, primarily reflecting lower volume demand in the U.S. resulting from its loss of exclusivity in August 2021; and
- Premarin in the U.S., down 31%, primarily driven by unfavorable changes in formulary coverage and temporary supply shortages of certain formulations of Premarin.
GAAP Reported(2) Income Statement Highlights
SELECTED REPORTED COSTS AND EXPENSES(2)
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| ($ in millions) | Fourth-Quarter |
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| Full-Year | ||||||
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| 2021 | 2020 | % Change |
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| 2021 | 2020 | % Change | ||
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| Total | Oper. |
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| Total | Oper. | ||||
| Cost of Sales(2) | $ 9,736 | $ 2,868 | * | * |
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| $ 30,821 | $ 8,484 | * | * |
| Percent of Revenues | 40.8% | 24.7% | N/A | N/A |
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| 37.9% | 20.4% | N/A | N/A |
| SI&A Expenses(2) | 4,104 | 3,753 | 9% | 10% |
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| 12,703 | 11,597 | 10% | 8% |
| R&D Expenses(2) | 5,915 | 3,351 | 76% | 77% |
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| 13,829 | 9,393 | 47% | 47% |
| Total | $ 19,754 | $ 9,972 | 98% | * |
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| $ 57,353 | $ 29,475 | 95% | 92% |
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| Other (Income)/Deductions––net(2) | ($835) | $102 | * | * |
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| ($4,878) | $1,219 | * | * |
| Effective Tax Rate on Reported Income(2) | 6.5% | (14.4%) |
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| 7.6% | 5.3% |
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* Indicates calculation not meaningful.
Fourth-quarter 2021 Cost of Sales(2) as a percentage of revenues increased 16.2 percentage points compared with the prior-year quarter. The drivers for the increase include, among other things:
- an increase of approximately 20 percentage points associated with sales of Comirnaty(1), which includes a charge for the 50% gross profit split with BioNTech and applicable royalty expenses,
partially offset by:
- net favorable changes in the sales mix of other products, including the impact of higher alliance revenues.
SI&A Expenses(2) increased 10% operationally in fourth-quarter 2021 compared with the prior-year quarter, primarily driven by increased product-related spending across multiple therapeutic areas, including costs related to Comirnaty, driven by a higher provision for healthcare reform fees based on sales.
Fourth-quarter 2021 R&D Expenses(2) increased 77% operationally compared with the prior-year quarter, primarily reflecting a $2.1 billion charge for in-process research and development (IPR&D) expense associated with the acquisition of Trillium Therapeutics Inc., which closed in fourth-quarter 2021, as well as up-front payments of $300 million and $50 million related to collaboration agreements signed in the fourth quarter with Beam Therapeutics, Inc. and BioNTech, respectively. Growth compared to the prior-year quarter was also driven by increased investments across multiple late-stage clinical programs, including additional spending related to the development of the oral COVID-19 treatment program.
Pfizer recorded $835 million of other income––net(2) in fourth-quarter 2021 compared with $102 million of other deductions––net(2) in fourth-quarter 2020. The period-over-period change was primarily driven by:
- lower asset impairment charges incurred in fourth-quarter 2021 compared to fourth-quarter 2020;
- an increase in net periodic benefit credits recorded in fourth-quarter 2021, primarily resulting from pension plan actuarial remeasurement gains; and
- the non-recurrence of certain losses on asset disposals in the prior-year quarter,
partially offset by:
- net losses on equity securities in fourth-quarter 2021 versus net gains on equity securities recognized in the prior-year quarter.
Pfizer’s effective tax rate on Reported income(2) for fourth-quarter 2021 increased compared to the prior-year quarter due to the change in the jurisdictional mix of earnings primarily related to Comirnaty and the non-recurrence of tax benefits associated with certain intangible asset impairments.
Adjusted(3) Income Statement Highlights
SELECTED ADJUSTED COSTS AND EXPENSES(3)
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| ($ in millions) | Fourth-Quarter |
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| Full-Year | ||||||
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| 2021 | 2020 | % Change |
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| 2021 | 2020 | % Change | ||
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| Total | Oper. |
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| Total | Oper. | ||||
| Adjusted Cost of Sales(3) | $ 9,710 | $ 2,842 | * | * |
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| $ 30,685 | $ 8,386 | * | * |
| Percent of Revenues | 40.7% | 24.4% | N/A | N/A |
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| 37.7% | 20.1% | N/A | N/A |
| Adjusted SI&A Expenses(3) | 3,941 | 3,580 | 10% | 10% |
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| 12,110 | 11,106 | 9% | 8% |
| Adjusted R&D Expenses(3) | 3,503 | 3,068 | 14% | 14% |
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| 10,523 | 8,872 | 19% | 18% |
| Total | $ 17,155 | $ 9,490 | 81% | 84% |
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| $ 53,318 | $ 28,364 | 88% | 86% |
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| Adjusted Other | ($728) | ($681) | 7% | 8% |
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| ($2,473) | ($1,779) | 39% | 38% |
| Effective Tax Rate on | 13.9% | 11.3% |
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| 15.3% | 13.7 % |
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* Indicates calculation not meaningful.
Reconciliations of Reported(2) to Adjusted(3) financial measures and associated footnotes can be found in the financial tables section of the press release located at the hyperlink below.
FULL-YEAR REVENUE SUMMARY (Full-Year 2021 vs. Full-Year 2020)
Full-year 2021 revenues totaled $81.3 billion, an increase of $39.6 billion, or 95%, compared to full-year 2020, reflecting operational growth of $38.4 billion, or 92%, and the favorable impact of foreign exchange of $1.2 billion, or 3%. Excluding the revenue contributions of Comirnaty(1) and Paxlovid, revenues for the full year grew 6% operationally. Operational growth compared to the prior year was driven primarily by:
- Global sales of Comirnaty;
- Strong growth of Eliquis globally;
- Oncology biosimilars, driven by growth following the launches of Ruxience, Zirabev and Trazimera;
- Pfizer CentreOne, led by manufacturing of legacy Upjohn products for Viatris and Comirnaty for BioNTech;
- Vyndaqel/Vyndamax in the U.S., developed Europe and Japan;
- the Hospital therapeutic area, primarily driven by the anti-infectives portfolio in international markets;
- Inlyta globally; and
- Xtandi in the U.S.,
partially offset primarily by lower revenues for:
- Prevnar/Prevenar 13 and Chantix globally;
- Enbrel outside the U.S.; and
- Sutent in developed markets.
RECENT NOTABLE DEVELOPMENTS (Since November 2, 2021)
Product Developments
- Cibinqo (abrocitinib)
- In December 2021, Pfizer announced that the European Commission (EC) approved the 100 mg and 200 mg doses of Cibinqo, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate and severe renal impairment (kidney failure) or certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19.
- In January 2022, Pfizer announced that the FDA approved Cibinqo for the treatment of adults living with refractory, moderate-to-severe AD whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Cibinqo is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.
- Bavencio (avelumab) — Today, Pfizer and Merck KGaA, Darmstadt, Germany are providing an update on the Phase 3 JAVELIN Lung 100 trial, which assessed the safety and efficacy of two dosing regimens of avelumab monotherapy compared with platinum-based doublet chemotherapy as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. While avelumab showed clinical activity in this population, the study did not meet the primary endpoints of overall survival and progression-free survival in the high PD-L1+ population for either of the avelumab dosing regimens evaluated. The safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program. Avelumab is not approved for the treatment of any patients with NSCLC. The outcome of the JAVELIN Lung 100 trial has no bearing on any of avelumab’s currently-approved indications. Full results of the study will be shared at a future date.
- Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA)
- Clinical and Research Developments
- In November 2021, Pfizer and BioNTech announced topline results from a longer-term analysis of the safety and efficacy of Comirnaty in individuals 12 through 15 years of age. The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of Comirnaty (30 µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose. The adverse event profile was generally consistent with other clinical safety data for Comirnaty.
- In December 2021, Pfizer and BioNTech announced results from an initial laboratory study demonstrating that serum antibodies induced by Comirnaty neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccinees one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses. Preliminary data showed that a third dose of Comirnaty increased the neutralizing antibody titers against the Omicron strain spike by 25-fold compared to two doses.
- In December 2021, Pfizer and BioNTech shared that following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of two 3 µg doses of BNT162b2 in children 6 months to under 5 years of age. Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis. The study, which is ongoing and remains blinded, will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group. Pfizer and BioNTech also plan to evaluate a third dose of the 10 µg formulation in children 5 to under 12 years of age.
- In January 2022, Pfizer and BioNTech announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.
- Clinical and Research Developments
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