Pfizer reports second-quarter 2021 results

Pfizer Inc. (NYSE: PFE) reported financial results for secondquarter 2021 and raised 2021 guidance⁽⁴⁾ for revenues and Adjusted diluted EPS⁽³⁾ driven by its updated expectations for contributions to 2021 performance from both BNT162b2, the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, as well as its business excluding BNT162b2⁽¹⁾.

Additionally, Pfizer published this morning on its website the second-quarter 2021 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to its R&D pipeline.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "The second quarter was remarkable in a number of ways. Most visibly, the speed and efficiency of our efforts with BioNTech to help vaccinate the world against COVID-19 have been unprecedented, with now more than a billion doses of BNT162b2 having been delivered globally. In addition, we are equally proud of the second-quarter performance of our business excluding BNT162b2⁽¹⁾, which posted 10% operational revenue growth. Looking forward, we remain highly confident in our ability to achieve at least a 6% compound annual growth rate through 2025 and intend to build upon our recent successes by continuing to follow the science, trust in our people and remain focused on delivering breakthroughs for the patients we serve."

Frank D'Amelio, Chief Financial Officer and Executive Vice President, Global Supply, stated: "Pfizer's second quarter performance highlighted once again the underlying strength of our business, with consistent and solid growth coming from multiple products and categories. It is important to point out that the 10% year-over-year operational revenue growth rate for our business excluding BNT162b2⁽¹⁾ comes on top of a strong 6% operational growth rate delivered by the comparable business in the second quarter of last year. As a result of updates to our expectations for our business, both including and excluding BNT162b2⁽¹⁾, we are increasing our 2021 financial guidance ranges for revenues and Adjusted diluted EPS⁽³⁾ for the second quarter in a row."

Results for the second quarter and the first six months of 2021 and 2020⁽⁵⁾ are summarized below.

OVERALL RESULTS

REVENUES

Following the completion of the spin-off of the Upjohn Business⁽⁶⁾ in the fourth quarter of 2020, Pfizer operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sale and distribution of biopharmaceutical products worldwide.

Revenues and expenses associated with the Upjohn Business⁽⁶⁾ for the first and second quarters of 2020 have been recategorized as discontinued operations and excluded from Adjusted⁽³⁾ results. Pfizer's Meridian subsidiary, the manufacturer of EpiPen and other auto-injector products, which had been reported within the results of the Upjohn Business⁽⁶⁾ in the first three quarters of 2020_, is now included within the Hospital therapeutic area for all periods presented.

Business development activities completed in 2020 and 2021 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⁾.

2021 FINANCIAL GUIDANCE⁽⁴⁾

Financial guidance reflects management's current expectations for operational performance, foreign exchange rates and management's current projections as to the severity, duration and global macroeconomic impact of the COVID-19 pandemic.

Key guidance assumptions included in these projections broadly reflect a continued recovery in global macroeconomic and healthcare activity throughout 2021 as more of the population becomes vaccinated against COVID-19.

Pfizer is raising its financial guidance ranges primarily to reflect higher expected revenues and related expenses for BNT162b2⁽¹⁾ and anticipated incremental spending on other COVID-19-related and mRNA-based programs, as well as increased expected contributions from its business excluding BNT162b2⁽¹⁾. The increase to guidance for the effective tax rate on Adjusted income⁽³⁾ resulted from updates to the anticipated jurisdictional mix of earnings, primarily related to BNT162b2⁽¹⁾. Current 2021 financial guidance is presented below.

The midpoint of the guidance range for revenues represents 89% growth from 2020 revenues, including an expected $1.5 billion, or 4%, favorable impact from changes in foreign exchange rates compared to 2020. The midpoint of the updated guidance range for Adjusted diluted EPS⁽³⁾ reflects a 77% increase over 2020 actual results⁽⁸⁾, including an expected $0.10, or 4%, benefit due to favorable changes in foreign exchange rates compared to 2020.

Financial guidance for Adjusted diluted EPS⁽³⁾ is calculated using approximately 5.7 billion weighted average shares outstanding, and does not currently assume any share repurchases in 2021.

Update to Assumptions Related to BNT162b2⁽¹⁾ Within Guidance

Due to additional supply agreements that have been signed from mid-April to mid-July, Pfizer is updating the revenue assumptions related to BNT162b2⁽¹⁾ incorporated within the above guidance ranges. The updated assumptions are summarized below.

The BNT162b2⁽¹⁾ revenue projection incorporated within Pfizer's 2021 financial guidance includes 2.1 billion doses that are expected to be delivered in 2021⁽⁵⁾ under contracts signed through mid-July 2021. This guidance may be adjusted in the future as additional contracts are signed. Based on current projections, Pfizer and BioNTech expect to manufacture in total up to 3 billion doses by the end of December 2021, subject to continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers.

Adjusted⁽³⁾ IBT margin guidance for BNT162b2⁽¹⁾ incorporates the current expectation for revenues for the product, less anticipated Adjusted⁽³⁾ costs to manufacture, market and distribute BNT162b2⁽¹⁾, including applicable royalty expenses and a 50% gross profit split with BioNTech, as well as shared R&D expenses related to BNT162b2⁽¹⁾ and costs associated with other assets currently in development for the prevention and treatment of COVID-19. It also includes R&D expenses related to other mRNA-based development programs. It does not include an allocation of corporate or other overhead costs.

Selected Financial Guidance Ranges Excluding BNT162b2⁽¹⁾

Pfizer is raising its financial guidance ranges for revenues and Adjusted diluted EPS⁽³⁾ excluding contributions from BNT162b2⁽¹⁾.

The midpoint of the revenue guidance range above reflects approximately 7% operational growth compared to 2020 when sales of BNT162b2⁽¹⁾ are excluded from both periods, which is in line with the company's stated goal of at least a 6% revenue compound annual growth rate through 2025. The midpoint of Pfizer's Adjusted diluted EPS⁽³⁾ guidance range excluding BNT162b2⁽¹⁾ reflects approximately 11% operational growth compared to the prior year⁽⁸⁾.

CAPITAL ALLOCATION

• During the first six months of 2021, Pfizer paid $4.4 billion of cash dividends, or $0.78 per share of common stock, which represents an increase in dividends per share of 3% compared to the same period last year.
• No share repurchases have been completed to date in 2021. As of July 28, 2021, Pfizer's remaining share repurchase authorization is $5.3 billion. Current 2021 financial guidance does not reflect any share repurchases in 2021.
• Second-quarter 2021 diluted weighted-average shares outstanding used to calculate Reported⁽²⁾ and Adjusted⁽³⁾ diluted EPS was 5,678 million shares, an increase of 59 million shares compared to the prior-year quarter primarily due to shares issued for employee compensation programs.

QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2021 vs. Second-Quarter 2020)

Second-quarter 2021 revenues totaled $19.0 billion, an increase of $9.1 billion, or 92%, compared to the prior-year quarter, reflecting operational growth of $8.5 billion, or 86%, as well as a favorable impact of foreign exchange of $637 million, or 6%.

Second-quarter 2021 operational growth was primarily driven by:

• BNT162b2⁽¹⁾, which contributed $7.8 billion in direct sales and alliance revenues;
• Vyndaqel/Vyndamax globally, up 77% operationally, primarily driven by continued strong uptake of the transthyretin amyloid cardiomyopathy indication in the U.S., developed Europe and Japan;
• Eliquis, up 13% operationally, led by growth in the U.S. and emerging markets, driven primarily by continued increased adoption in non-valvular atrial fibrillation and oral anti-coagulant market share gains;
• Prevnar 13 in the U.S., up 34%, driven by:
  • 35% growth in the pediatric indication primarily due to higher levels of healthcare activity and wellness visits compared to the prior-year quarter, which was heavily impacted by COVID-19-related mobility restrictions and limitations, and favorable timing of government purchases, partially offset by a lower year-over-year birth rate⁽⁹⁾, and
  • 24% growth in the adult indication, which was primarily driven by higher levels of healthcare activity compared to the prior-year quarter, as described above, partially offset by the impact of a lower remaining eligible unvaccinated population;
• Ibrance outside of the U.S., up 21% operationally, driven by accelerating demand as the delays in diagnosis and treatment initiations caused by COVID-19 show signs of recovery across several international markets;
• Inlyta globally, up 29% operationally, primarily reflecting increased adoption in the U.S. and developed Europe of combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma;
• Xtandi in the U.S., up 14%, primarily driven by strong demand across the metastatic and non-metastatic castration-resistant prostate cancer indications and the metastatic castration-sensitive prostate cancer indication; as well as
• Hospital products globally, which grew 17% operationally to $2.3 billion, primarily driven by Pfizer CentreOne, Pfizer's contract manufacturing operation, reflecting manufacturing of legacy Upjohn products for Viatris⁽⁶⁾, certain BNT162b2 manufacturing activities performed on behalf of BioNTech⁽¹⁾ and remdesivir for Gilead Sciences Inc., as well as growth from recent anti-infective product launches in international markets, partially offset by a decline in U.S. sales of certain sterile injectable products utilized in the intubation and mechanical ventilation of patients being treated for COVID-19 due to high demand for these products in the prior-year quarter; and
• Biosimilars globally, which grew 88% operationally to $559 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Zirabev (bevacizumab), Ruxience (rituximab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.,

partially offset primarily by lower revenues for:

• Xeljanz in the U.S., down 15%, despite 2% year-over-year growth in U.S. prescription volume, reflecting an unfavorable change in channel mix toward lower-priced channels and continued investments to improve formulary positioning and unlock access to additional patient lives, as well as a negative impact on new patient starts resulting from an ongoing review by the Food and Drug Administration (FDA) of safety data from the post-marketing ORAL Surveillance study of Xeljanz in subjects with rheumatoid arthritis who were 50 years of age or older and had at least one additional cardiovascular risk factor;
• Ibrance in the U.S., down 7%, despite maintaining a strong leadership position in the CDK 4/6 class with 73% share of first-line new patient starts, reflecting an increase in the proportion of patients accessing Ibrance through Pfizer's Patient Assistance Program;
• Enbrel internationally, down 19% operationally, primarily reflecting continued biosimilar competition in developed Europe and Japan; and
• Prevenar 13 in developed Europe, down 35% operationally, reflecting significantly increased adult demand in the prior-year quarter in Germany and certain other markets resulting from greater vaccine awareness for respiratory illnesses due to the COVID-19 pandemic.

GAAP Reported⁽²⁾ Income Statement Highlights

SELECTED REPORTED COSTS AND EXPENSES⁽²⁾

Second-quarter 2021 Cost of Sales⁽²⁾ as a percentage of revenues increased 18.6 percentage points compared with the prior-year quarter. The drivers for the increase include, among other things:

• an increase of approximately 15 percentage points associated with sales of BNT162b2⁽¹⁾, which includes a charge for the 50% gross profit split with BioNTech and applicable royalty expenses;
• unfavorable changes in product mix, reflecting higher sales of lower margin products including revenues from the Pfizer CentreOne operation, partially offset by the favorable impact of higher alliance revenues; and
• unfavorable foreign exchange impacts.

SI&A Expenses⁽²⁾ increased 8% operationally in second-quarter 2021 compared with the prior-year quarter, primarily due to increased product-related spending across multiple therapeutic categories and other costs associated with a return to more normal activity levels compared to the prior-year quarter, partially offset by a reduction in spending for corporate enabling functions and lower spending for Chantix following its loss of patent protection in the U.S. in November 2020.

Second-quarter 2021 R&D Expenses⁽²⁾ increased 17% operationally compared with the prior-year quarter, which primarily reflects incremental investments across multiple therapeutic categories, including additional spending related to the development of BNT162b2⁽¹⁾ and therapeutics to help treat COVID-19, as well as a charge for in-process R&D related to an asset acquisition completed in the second quarter of 2021, partially offset by the non-recurrence of upfront payments associated with two R&D agreements executed in second-quarter 2020.

Other income--net⁽²⁾ in second-quarter 2021 decreased 5% operationally compared with second-quarter 2020, primarily driven by higher legal charges and lower income from collaborations, partially offset by higher transition services agreement income, higher net gains on both equity securities and asset disposals, lower interest expense and higher net periodic benefit credits related to pension and postretirement plans.

Pfizer's effective tax rate on Reported income⁽²⁾ for second-quarter 2021 compared to the prior-year quarter increased due to an unfavorable change in the jurisdictional mix of earnings primarily related to BNT162b2⁽¹⁾.

Adjusted⁽³⁾ Income Statement Highlights

SELECTED ADJUSTED COSTS AND EXPENSES⁽³⁾

Changes in Adjusted⁽³⁾ costs and expenses in second-quarter 2021 compared to the prior-year quarter were driven primarily by the factors listed in the Reported⁽²⁾ costs and expenses section above.

A full reconciliation 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.

RECENT NOTABLE DEVELOPMENTS (Since May 4, 2021)

Product Developments

• Chantix (varenicline) -- In July 2021, Pfizer issued a voluntary recall in the U.S. for twelve lots of Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer-established acceptable daily intake level. Nitrosamines are common in water and foods and everyone is exposed to some level of nitrosamines. These impurities may theoretically increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
• Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) -- In May 2021, Myovant Sciences (Myovant) and Pfizer announced that the FDA approved Myfembree, the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. Myovant and Pfizer are jointly commercializing Myfembree in the U.S.
• Prevnar 20 (pneumococcal 20-valent conjugate vaccine) -- In June 2021, Pfizer announced that the FDA approved Prevnar 20 for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.
• Talzenna (talazoparib) -- In June 2021, Pfizer announced that the first participant had been dosed in the Phase 3 TALAPRO-3 study, which will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer. The anticipated primary completion date is late-2024.
• Xeljanz (tofacitinib)
  • In June 2021, Pfizer announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended that Xeljanz should only be used in patients over 65 years of age, patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors, if no suitable treatment alternative is available. The recommendation, which has since been adopted by the EMA's Committee for Medicinal Products for Human Use (CHMP), is based on the receipt of safety data from the post-marketing ORAL Surveillance study of Xeljanz in subjects with rheumatoid arthritis who were 50 years of age or older and had at least one cardiovascular risk factor.
  • In June 2021, Pfizer, in collaboration with The Academic Research Organization (ARO) from the Hospital Israelita Albert Einstein, announced that The New England Journal of Medicine had published positive findings from the STOP-COVID study (NCT04469114) evaluating the efficacy and safety of its oral Janus kinase (JAK) inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation. Tofacitinib has not been approved or authorized for use by any regulatory authority worldwide for the treatment of COVID-19 and tofacitinib should not be used in patients with an active serious infection. Pfizer is assessing next steps.
  • In July 2021, the FDA notified Pfizer that it would not meet the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Applications (sNDA) for Xeljanz/Xeljanz XR for the treatment of adults with active ankylosing spondylitis. The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in subjects with rheumatoid arthritis who were 50 years of age or older and had at least one additional cardiovascular risk factor, as a factor for the extension. No revised PDUFA goal date has been set for these sNDAs.

Pipeline Developments

A comprehensive update of Pfizer's development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer's research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

• Abrocitinib (PF-04965842) -- In July 2021, the FDA notified Pfizer that it would not meet the PDUFA goal date for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in subjects with rheumatoid arthritis who were 50 years of age or older and had at least one cardiovascular risk factor, as a factor for the extension. No revised PDUFA goal date has been set for this NDA.
• BNT162b2 (COVID-19 Vaccine) Development Program
  • Clinical and Research Developments
    • In June 2021, Pfizer and BioNTech initiated a Phase 2/3 study to further evaluate the safety, tolerability and immunogenicity of BNT162b2 in preventing COVID-19 in healthy children between the ages of 6 months to 11 years old. The companies expect to have the safety and immunogenicity data that could potentially support an Emergency Use Authorization (EUA) for use in children ages 5 to 11 years old, if such an EUA is deemed necessary, by the end of September. The full dataset from this study, which will be required to support licensure in this age group, is expected by the end of 2021. Similar data packages will be submitted shortly thereafter to support EUA and licensure in children 6 months to 5 years of age.
    • In July 2021, Pfizer and BioNTech provided an update on the ongoing Phase 1/2/3 booster trial of a third dose of the current BNT162b2 vaccine. Initial safety and immunogenicity data from the study demonstrate that a booster dose given at least 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta (B.1.351) variant, which are 5 to 10 times higher than after two primary doses. In addition, newly disclosed data demonstrates that a third dose elicits neutralizing titers against the Delta (B.1.617.2) variant that are more than five times higher in younger people and more than 11 times higher in older people than after two doses. The companies expect to publish more definitive data about the analysis and all accumulated data will be shared as part of the ongoing discussions with the FDA, EMA and other regulatory authorities in the coming weeks.
    • In July 2021, Pfizer and BioNTech initiated the global Phase 3 portion of the clinical study to evaluate the efficacy, safety and tolerability of a third dose of BNT162b2 compared to placebo, including evaluating the booster's efficacy at continuing to prevent COVID-19 infection. The Phase 3 study will enroll 10,000 participants who participated in the original Phase 3 trial.
  • Regulatory Developments
    • In May 2021, Pfizer and BioNTech received approval from the EMA to extend the storage period of an unopened thawed vial of BNT162b2 at 2-8°C from five days to one month (31 days) to facilitate the handling of the vaccine in vaccination centers across the European Union (EU).
    • In May 2021, Pfizer and BioNTech announced expanded authorization in the EU as part of its Conditional Marketing Authorization (CMA), and separately expanded authorization in the U.S. as part of its EUA, for use of BNT162b2 in individuals 12 to 15 years of age. BNT162b2 is the first COVID-19 vaccine to be authorized for use in this age group⁽¹⁰⁾.
    • In July 2021, Pfizer and BioNTech announced that the FDA granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. This follows the completion of the rolling submission of the BLA in May 2021, which includes data from the pivotal Phase 3 clinical trial of the vaccine, where the vaccine's efficacy and favorable safety profile were observed up to six months after the second dose. The PDUFA goal date for a decision by the FDA is in January 2022.
  • Commercial Developments
    • In May 2021, Pfizer and BioNTech announced an agreement with the European Commission (EC) to supply 900 million doses of BNT162b2 to the EU, with an option for the EU to request up to an additional 900 million doses for a total of up to 1.8 billion doses. The 900 million agreed doses are expected to be delivered on a monthly schedule beginning in December 2021 and continuing into 2023. This new agreement is in addition to the 600 million doses that had already been committed to the EU through 2021.
    • In June 2021, Pfizer and BioNTech announced plans to provide 500 million doses of BNT162b2 to the U.S. government at a not-for-profit price for donation to approximately 100 low- and lower middle-income countries including those in the African Union via the COVAX Facility. Deliveries under the agreement will begin in August 2021, with 200 million doses to be delivered through the end of 2021 and the remaining 300 million doses to be delivered in the first half of 2022. The agreement also provides the U.S. government with an option for additional doses in 2022.
    • In July 2021, Pfizer and BioNTech announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd (Biovac), a South African biopharmaceutical company, to manufacture BNT162b2 for distribution within the African Union. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, annual production is estimated to be approximately 100 million finished doses. All doses will exclusively be distributed within the 55 member states that make up the African Union.
    • In July 2021, Pfizer and BioNTech announced that the U.S. government has agreed to purchase an additional 200 million doses of BNT162b2, of which 110 million doses are expected to be delivered from October through December 2021 with the remainder expected to be delivered from January through April 2022. This brings the total number of doses to be supplied to the U.S. government under its existing supply agreement to 500 million. This agreement is separate from the 500 million doses to be provided to the U.S. government for donation to the world's poorest nations, which was announced in June 2021.
• PF-07304814 (Intravenous Protease Inhibitor for COVID-19) -- Following a communication from the FDA in July 2021, Pfizer anticipates the initiation of a Phase 2/3 study in third-quarter 2021 of its intravenous protease inhibitor clinical candidate, PF-07304814, a potential novel treatment option for hospitalized patients with COVID-19.