PFIZER REPORTS STRONG THIRD-QUARTER 2022 RESULTS AND RAISES 2022 OUTLOOK

• Solid Third-Quarter 2022 Revenues of $22.6 Billion
  • Due to Exceptionally Strong Growth Achieved in the Prior-Year Quarter, Revenues Declined 2% Operationally
  • Excluding Contributions from Paxlovid and Comirnaty⁽¹⁾, Revenues Grew 2% Operationally
• Third-Quarter 2022 Reported Diluted EPS⁽²⁾ of $1.51, Reflecting 6% Growth Over Third-Quarter 2021, Including a $0.15 Incremental Benefit in the Current Period Related to Tax Resolutions for Multiple Years Impacting Both Reported⁽²⁾ and Adjusted⁽³⁾ Diluted EPS
• Third-Quarter 2022 Adjusted Diluted EPS⁽³⁾ of $1.78, Reflecting 40% Growth Over Third-Quarter 2021; Excluding Foreign Exchange Impacts, Adjusted Diluted EPS⁽³⁾ Grew 44%
• Raises Lower End of Full-Year 2022 Revenue Guidance⁽⁴⁾ to a Range of $99.5 to $102.0 Billion, Reflecting an Improved Operational Outlook Combined with Incremental Unfavorable Foreign Exchange Impacts
  • Raises 2022 Revenue Guidance for Comirnaty⁽¹⁾ by $2 Billion to ~$34 Billion and Reaffirms Revenue Guidance for Paxlovid of ~$22 Billion, Despite Unfavorable Impacts from Foreign Exchange
• Raises and Narrows Full-Year 2022 Adjusted Diluted EPS⁽³⁾ Guidance from $6.30 to $6.45 to $6.40 to $6.50
• Pipeline Programs That Have Achieved Positive Phase 3 Readouts Since Previous Earnings Release Include RSVpreF Vaccine in Older Adults & Maternal, Prevnar 20/Apexxnar in Pediatrics, Talzenna/Xtandi Combination in mCRPC and Pentavalent Meningococcal Vaccine in Adolescents and Young Adults
• Pfizer to Host Analyst Event on December 12 in New York City, Where It Will Showcase Its Portfolio of Upcoming Product Launches and Other Pipeline Programs with High-Value Potential

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) reported solid financial results for third-quarter 2022 and updated certain components of 2022 financial guidance⁽⁴⁾. Pfizer raised the lower end of its 2022 revenue guidance range, while raising and narrowing its Adjusted diluted EPS⁽³⁾ guidance, despite unfavorable impacts from foreign exchange. Revenue guidance for Comirnaty⁽¹⁾ was raised by $2 billion, and was reaffirmed for Paxlovid.

The third-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “I continue to be proud of our colleagues’ excellence, ingenuity and unwavering commitment to bringing breakthroughs to patients. Over the next 18 months, we expect to have up to 19 new products or indications in the market – including the five for which we have already begun co-promotion or commercialization earlier this year. Many of these 19 programs are already largely de-risked from a clinical perspective, the majority were discovered in-house, and nearly all would be for indications outside of COVID-19. This quarter, we set the stage for these potential launches by reorganizing our commercial operations to better capitalize on these opportunities. We also reported positive pivotal data for several of these exciting pipeline programs, including our RSV vaccine candidate for older adults and for infants through maternal vaccination, Prevnar 20 for children, the potential combination treatment of Talzenna and Xtandi in men with metastatic castration-resistant prostate cancer, and our pentavalent meningococcal vaccine candidate for adolescents and young adults. If approved, we expect each of these to be key contributors to our growth aspirations through 2025 and beyond.”

David Denton, Chief Financial Officer and Executive Vice President, stated: “Third-quarter results demonstrated commercial strength across many areas of our business, but was somewhat obscured by the incredibly strong performance in the prior year. We saw strong operational performance this quarter from key brands such as Paxlovid and Eliquis, particularly in the U.S., as well as the continued impressive launch of Prevnar 20 for adults in the U.S. In addition, we continue to make progress toward our goal of adding at least $25 billion in risk-adjusted 2030 revenues to Pfizer’s portfolio through business development. Since we last reported earnings, we completed the acquisitions of Biohaven and Global Blood Therapeutics, each of which bring significant scientific breakthroughs to Pfizer and which present opportunities where we believe we can add great value. I look forward to continuing to execute on Pfizer’s strategies to deliver breakthroughs to patients and value to shareholders.”

Results for the third quarter and the first nine months of 2022 and 2021⁽⁵⁾ are summarized below.

OVERALL RESULTS

REVENUES

Beginning in the first quarter of 2022, Adjusted⁽³⁾ financial measures include expenses for all acquired in-process research and development (IPR&D) costs incurred in connection with upfront and milestone payments on collaboration and in-license agreements, including premiums on equity securities, as well as asset acquisitions of acquired IPR&D and are reported as a separate income statement line item. Previously, these costs were recorded within the R&D expenses line item and certain of these costs were excluded from Adjusted⁽³⁾ results. The change to include all acquired IPR&D expenses within Adjusted⁽³⁾ results negatively impacted Adjusted⁽³⁾ diluted EPS in the third quarters of 2022 and 2021 by $0.07 and $0.09, respectively.

Also in the first quarter of 2022, Pfizer implemented a change in policy to exclude all amortization of intangibles from Adjusted⁽³⁾ income, which favorably impacted Adjusted⁽³⁾ diluted EPS by $0.01 in third-quarter 2022 and by $0.02 in third-quarter 2021.

Beginning in the third quarter of 2022, Pfizer made several organizational changes to further transform its operations to better leverage its expertise in certain areas and in anticipation of potential future new product launches. These changes include establishing a new commercial structure within its Biopharma operating segment focused on three broad therapeutic areas (primary care, specialty care and oncology) and realigning certain enabling and platform functions across the organization to ensure alignment with this new operating structure⁽⁶⁾.

Prior period amounts have been revised to conform to the current period presentation for all changes discussed above.

Business development activities⁽⁷⁾ completed in 2021 and 2022⁽⁵⁾ impacted financial results in the periods presented. 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⁽⁸⁾.

2022 FINANCIAL GUIDANCE⁽⁴⁾

Pfizer raised its 2022 financial guidance, on an operational basis⁽⁸⁾, for revenues and Adjusted diluted EPS⁽³⁾ by approximately $1.7 billion and $0.19, respectively. After including the expected incremental unfavorable impacts of changes in foreign exchange rates since last quarter’s earnings report, the midpoints of the guidance ranges for revenues and Adjusted diluted EPS⁽³⁾ were increased by $750 million and $0.075, respectively.

Financial guidance ranges now reflect the closing of the Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) and Global Blood Therapeutics, Inc. (GBT) acquisitions, which occurred early in the fourth quarter of 2022.

The midpoint of the guidance range for revenues reflects a 31% operational increase compared to 2021 revenues of $81.3 billion. This guidance includes the following assumptions related to Pfizer’s COVID-19-related products:

• Comirnaty⁽¹⁾ revenues of approximately $34 billion, which reflects favorable operational updates compared to prior guidance, partially offset by unfavorable incremental impacts from foreign exchange. This guidance includes doses expected to be delivered in fiscal 2022⁽⁵⁾, primarily under contracts signed as of mid-October 2022.
• Paxlovid revenues of approximately $22 billion, which remains unchanged from prior guidance. This guidance includes treatment courses expected to be delivered in fiscal 2022⁽⁵⁾, primarily relating to supply contracts signed or committed as of mid-October 2022.

The midpoint of the guidance range for Adjusted diluted EPS⁽³⁾ was raised by $0.075, despite an unfavorable $0.06 impact due to incremental acquired IPR&D expenses. This updated guidance reflects a 70% operational increase at the midpoint over the 2021 Adjusted diluted EPS⁽³⁾ of $4.06, which has been revised from its original presentation to exclude all amortization of intangibles and to include the impact of all acquired IPR&D expenses.

Financial guidance for Adjusted diluted EPS⁽³⁾ is calculated using approximately 5.75 billion weighted average shares outstanding, and assumes no additional share repurchases in 2022. The expected increase in weighted average shares outstanding compared to 2021 of approximately 50 million shares has an unfavorable impact on 2022 Adjusted diluted EPS⁽³⁾ of $0.04 at the midpoint of the guidance range.

Other components of Pfizer’s 2022 financial guidance, all of which are presented with the expected impacts from changes in foreign exchange rates included, are presented below.

Guidance for Adjusted⁽³⁾ cost of sales as a percentage of revenues was tightened around the higher end of the previous range, primarily reflecting the increase in revenue expectations for Comirnaty⁽¹⁾.

Guidance for Adjusted⁽³⁾ SI&A expenses was raised by $350 million at the midpoint and now includes additional spending related to recent acquisitions.

Guidance for acquired IPR&D expenses⁽⁴⁾ was increased by $500 million, primarily as a result of the acquisition of Biohaven early in the fourth quarter of 2022.

Guidance for the effective tax rate on Adjusted⁽³⁾ income was lowered by 3.0 percentage points compared to the previous guidance, reflecting tax benefits recorded in the third quarter of 2022 related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years, among other drivers.

CAPITAL ALLOCATION

During the first nine months of 2022, Pfizer deployed its capital in a variety of ways, which primarily include the following two broad categories:

• Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
  • $7.8 billion invested in internal research and development projects, and
  • Approximately $8 billion invested in completed business development transactions, including approximately $6.4 billion⁽⁷⁾ for the acquisition of Arena Pharmaceuticals, Inc. and approximately $0.4 billion for the acquisition of ReViral Ltd. (ReViral).
• Returning capital directly to shareholders through a combination of:
  • $6.7 billion of cash dividends, or $1.20 per share of common stock, and
  • $2.0 billion, which was used to repurchase 39.1 million shares on the open market in March 2022, at an average cost of $51.10 per share.

In addition to the capital investments listed above, early in the fourth quarter of 2022, Pfizer completed the acquisitions of Biohaven and GBT requiring total upfront capital deployments of approximately $12.8 billion and $5.6 billion, respectively, which includes the amounts paid for the acquired companies’ common shares, employee stock awards, outstanding debt and any preferred shares, less any cash acquired.

As of November 1, 2022, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any additional share repurchases in 2022.

Third-quarter 2022 diluted weighted-average shares outstanding used to calculate Reported⁽²⁾ and Adjusted⁽³⁾ diluted EPS were 5,718 million shares, a decrease of 7 million shares compared to the prior-year quarter, primarily due to shares repurchased in first-quarter 2022, partially offset by shares issued for employee compensation programs.

QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2022 vs. Third-Quarter 2021)

Third-quarter 2022 revenues totaled $22.6 billion, a decrease of $1.4 billion, or 6%, compared to the prior-year quarter, reflecting an operational decline of $441 million, or 2%, as well as an unfavorable impact of foreign exchange of $957 million, or 4%. Excluding contributions from Paxlovid and Comirnaty⁽¹⁾, company revenues grew $213 million, or 2%, operationally.

Third-quarter 2022 operational decline was primarily driven by:

• Comirnaty⁽¹⁾ outside the U.S., down 86% operationally, driven primarily by a previously announced amendment to the supply agreement with the European Commission (EC) whereby all doses scheduled for delivery in June through August 2022 would instead be delivered in the fourth quarter of 2022 and similar shifts in scheduled deliveries to other developed countries, as well as slower demand in emerging markets;
• Lower revenues for certain Comirnaty-related manufacturing activities⁽¹⁾ performed on behalf of BioNTech SE (BioNTech), which decreased 96% operationally compared to the prior-year quarter;
• Xeljanz globally, down 14% operationally, driven primarily by decreased prescription volumes resulting from ongoing shifts in prescribing patterns related to Janus kinase (JAK) class label changes; and
• Sutent globally, down 43% operationally, primarily driven by lower volume demand in Europe following its loss of exclusivity in January 2022,

partially offset primarily by higher revenues for:

• Paxlovid, which contributed $7.5 billion in global revenues, driven by the U.S. launch under emergency use authorization (EUA) in December 2021 and international launches in late 2021 and early 2022 following regulatory approvals or EUAs;
• Comirnaty⁽¹⁾ in the U.S., up 83%, driven primarily by deliveries of the Omicron BA.4/BA.5-adapted bivalent booster, following its EUA in late-August 2022, as well as the granting of an EUA in June 2022 for a primary vaccination series for children 6 months to less than 5 years of age;
• Prevnar family (Prevnar 13 & 20) in the U.S., up 28%, driven by strong patient demand following the launch of Prevnar 20 for the eligible adult population, partially offset by unfavorable timing of government and private purchasing of Prevnar 13 for the pediatric indication;
• Eliquis in the U.S., up 33%, driven primarily by continued oral anti-coagulant adoption and market share gains in non-valvular atrial fibrillation, as well as favorable changes in channel mix; and
• Vyndaqel/Vyndamax globally, up 29% operationally, driven by continued strong uptake of the transthyretin amyloid cardiomyopathy indication, primarily in the U.S. and developed Europe, partially offset by a planned price decrease that went into effect in Japan in second-quarter 2022.

GAAP Reported⁽²⁾ Income Statement Highlights

SELECTED REPORTED COSTS AND EXPENSES⁽²⁾

* Indicates calculation not meaningful.

Third-quarter 2022 Cost of Sales⁽²⁾ as a percentage of revenues decreased 14.5 percentage points compared with the prior-year quarter. The decrease was primarily driven by favorable changes in sales mix, including significant sales of Paxlovid and lower sales of Comirnaty⁽¹⁾, as well as favorable impacts resulting from changes in foreign exchange rates, partially offset by a charge of approximately $400 million related to excess raw materials for Paxlovid.

SI&A Expenses⁽²⁾ increased 21% operationally compared with the prior-year quarter, primarily reflecting increased spending for Paxlovid and Comirnaty⁽¹⁾ and a higher provision for U.S. healthcare reform fees based on sales of Paxlovid and Comirnaty⁽¹⁾, as well as additional investments to support recently launched products.

Third-quarter 2022 R&D Expenses⁽²⁾ increased 2% operationally compared with the prior-year quarter, primarily driven by increased costs to develop recently acquired assets, as well as investments for certain oncology and non-COVID-19 vaccines programs, partially offset by lower spending on programs to prevent and treat COVID-19 and various late-stage clinical programs.

Acquired IPR&D Expenses⁽²⁾ decreased 31% operationally compared with the prior-year quarter. In third-quarter 2022, Acquired IPR&D Expenses⁽²⁾ primarily included the upfront payment related to the closing of the acquisition of ReViral. In third-quarter 2021, it mainly included an upfront payment related to Pfizer’s global collaboration agreement with Arvinas, Inc.

Other income––net⁽²⁾ decreased 99% operationally in third-quarter 2022 compared with third-quarter 2021, primarily driven by:

• lower net periodic benefit credits associated with pension and postretirement plans incurred in third-quarter 2022 compared to the prior-year quarter;
• net losses on equity securities in third-quarter 2022 versus net gains on equity securities recognized in the prior-year quarter; and
• a $200 million intangible asset impairment charge in third-quarter 2022 associated with the discontinuation of the PF-07265803 (lamin A/C protein (LMNA)-related dilated cardiomyopathy) clinical program.

Pfizer’s effective tax rate on Reported income⁽²⁾ for third-quarter 2022 was impacted by tax benefits related to global income tax resolutions in multiple tax jurisdictions spanning multiple tax years that included the closing of U.S. Internal Revenue Service audits covering five tax years. Pfizer’s effective tax rate for third-quarter 2021 was negative, primarily as a result of certain initiatives executed in third-quarter 2021 associated with Pfizer’s investment in the Consumer Healthcare joint venture with GlaxoSmithKline plc.

Adjusted⁽³⁾ Income Statement Highlights

SELECTED ADJUSTED⁽³⁾ COSTS AND EXPENSES

Reconciliations of certain 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.

RECENT NOTABLE DEVELOPMENTS (Since July 28, 2022)

Product Developments

• Comirnaty (COVID-19 vaccine, mRNA)⁽⁹⁾
  • Clinical and Research Developments
    • In August 2022, Pfizer and BioNTech announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of Comirnaty in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022. Vaccine efficacy, a secondary endpoint in the trial, was 73.2% (2-sided 95% CI: 43.8%, 87.6%) among children 6 months through 4 years of age without evidence of prior COVID-19 infection. This analysis was based on 13 cases in the vaccine group (n=794) and 21 cases in the placebo group (n=351), diagnosed from March to June 2022. Three 3-µg doses of Comirnaty continued to be well-tolerated in this age group.
    • In October 2022, Pfizer and BioNTech announced early data from a Phase 2/3 clinical trial evaluating the safety, tolerability and immunogenicity of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine. A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 participants in each age group). Together, these data suggest a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine is anticipated to provide better protection against the Omicron BA.4 and BA.5 variants than the original vaccine for younger and older adults. The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data indicating a favorable safety profile, similar to that of the original vaccine.
  • U.S. Regulatory Developments
    • In August 2022, Pfizer and BioNTech announced the U.S. Food and Drug Administration (FDA) granted EUA of a 30-µg booster dose of an Omicron-adapted bivalent vaccine for individuals ages 12 years and older. The authorization of the bivalent COVID-19 vaccine is based on clinical data from Pfizer and BioNTech’s Omicron BA.

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