PFIZER REPORTS THIRD-QUARTER 2021 RESULTS

• Third-Quarter 2021 Revenues of $24.1 Billion, Reflecting 130% Operational Growth; Excluding Comirnaty⁽¹⁾, Revenues Grew 7% Operationally to $11.1 Billion
• Third-Quarter 2021 Reported Diluted EPS⁽²⁾ of $1.42, Adjusted Diluted EPS⁽³⁾ of $1.34
• Raises Full-Year 2021 Guidance⁽⁴⁾ for Revenues to a Range of $81.0 to $82.0 Billion and Adjusted Diluted EPS⁽³⁾ to a Range of $4.13 to $4.18, Reflecting 94% and 84% Year-Over-Year Growth at the Midpoints, Respectively
  • Anticipates 2021 Revenues of Approximately $36 Billion for Comirnaty⁽¹⁾, Reflecting 2.3 Billion Doses Expected to be Delivered in Fiscal 2021
  • Raises Midpoint of Guidance for Adjusted Diluted EPS⁽³⁾ Excluding Comirnaty⁽¹⁾ to a Range of $2.60 to $2.65
• Will Highlight Promising New Data on Multiple Novel Compounds in I&I, as Well as Clinical and Regulatory Updates for Gene Therapy and COVID-19 Development Programs on Conference Call

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) reported financial results for third-quarter 2021 and raised 2021 guidance⁽⁴⁾ for revenues and Adjusted diluted EPS⁽³⁾ reflecting the net impact of its updated expectations for contributions to 2021 performance from both Comirnaty⁽¹⁾, the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, as well as its business excluding Comirnaty⁽¹⁾.

Additionally, Pfizer published this morning on its website the third-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: “While we are proud of our third quarter financial performance, we are even more proud of what these financial results represent in terms of the positive impact we are having on human lives around the world. For example, more than 75% of the revenues we have recorded up through third-quarter 2021 for Comirnaty⁽¹⁾ have come from supplying countries outside the U.S., and we remain on track to achieve our goal of delivering at least two billion doses to low- and middle-income countries by the end of 2022 — at least one billion to be delivered this year and one billion next year, with the possibility to increase those deliveries if more orders are placed by these countries for 2022. One billion of these doses will be supplied to the U.S. government at a not-for-profit price to be donated to the world’s poorest nations at no charge to those countries. Despite all we have been able to accomplish to date, we remain focused on our future, not our past. Our ultimate goal is to help bring this pandemic to an end as quickly as possible, but also to apply the lessons we have learned through our work on the vaccine to all of our therapeutic areas. We look forward to providing future updates on these efforts.”

Frank D’Amelio, Chief Financial Officer and Executive Vice President, Global Supply, stated: “I continue to be very pleased with the way our business is performing in 2021, both including and excluding the significant contributions of Comirnaty⁽¹⁾ to our results. In addition to raising our expectations for revenues and Adjusted diluted EPS⁽³⁾ for the company including Comirnaty⁽¹⁾, today we are also increasing the midpoint of our guidance range for Adjusted diluted EPS⁽³⁾ excluding Comirnaty⁽¹⁾ for the second consecutive quarter, demonstrating our ability to execute on our broader strategies beyond the vaccine. We continue to make progress on advancing our internal pipeline across all therapeutic areas while also prudently deploying our capital through partnerships and bolt-on acquisitions to gain access to cutting-edge platforms, science and technologies that could potentially bolster our growth in the latter half of this decade. I am proud of what we have accomplished so far in 2021 and look forward to finishing the year strong.”

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

OVERALL RESULTS
($ in millions, except per share amounts)	Third-Quarter										Nine Months
	2021			2020			Change				2021			2020			Change
Revenues	$	24,094		$	10,277		134%				$	57,653		$	30,224		91%
Reported Net Income(2)		8,146			1,469		*					18,586			8,313		*
Reported Diluted EPS(2)		1.42			0.26		*					3.27			1.48		*
Adjusted Income(3)		7,687			3,303		133%					19,033			10,322		84%
Adjusted Diluted EPS(3)		1.34			0.59		129%					3.35			1.84		82%
* Indicates calculation not meaningful.

REVENUES
($ in millions)	Third-Quarter												Nine Months
	2021			2020			% Change						2021			2020			% Change
							Total		Oper.										Total		Oper.
Vaccines	$	14,583		$	1,717		*		*				$	28,711		$	4,574		*		*
Oncology		3,085			2,761		12%		11%					9,091			7,843		16%		14%
Internal Medicine		2,097			2,085		1%		(1%)					7,093			6,695		6%		4%
Hospital		2,367			1,790		32%		29%					6,968			5,741		21%		18%
Inflammation & Immunology		1,094			1,173		(7%)		(7%)					3,200			3,299		(3%)		(5%)
Rare Disease		869			752		16%		15%					2,588			2,071		25%		22%
Total Revenue	$	24,094		$	10,277		134%		130%				$	57,653		$	30,224		91%		86%
* Indicates calculation not meaningful.

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 all prior year periods presented 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 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.

Pfizer is raising 2021 total company guidance for revenues and Adjusted diluted EPS⁽³⁾. This reflects the net impact of its updated outlook for contributions to 2021 performance from both Comirnaty⁽¹⁾ and its business excluding Comirnaty⁽¹⁾. The guidance range for Adjusted⁽³⁾ R&D expenses was increased primarily to reflect anticipated incremental spending on COVID-19 and mRNA-based projects. Ranges for various other components of financial guidance were tightened within their previous ranges primarily to reflect the passage of time and actual performance to date. Current 2021 financial guidance is presented below.

Revenues	$81.0 to $82.0 billion
	(previously $78.0 to $80.0 billion)
Adjusted Cost of Sales(3) as a Percentage of Revenues	39.1% to 39.6%
	(previously 39.0% to 40.0%)
Adjusted SI&A Expenses(3)	$11.6 to $12.1 billion
	(previously $11.5 to $12.5 billion)
Adjusted R&D Expenses(3)	$10.4 to $10.9 billion
	(previously $10.0 to $10.5 billion)
Adjusted Other (Income)/Deductions(3)	Approximately $2.3 billion of income
	(previously approximately $2.2 billion of income)
Effective Tax Rate on Adjusted Income(3)	Approximately 16.0%
Adjusted Diluted EPS(3)	$4.13 to $4.18
	(previously $3.95 to $4.05)

The midpoint of the guidance range for revenues represents 94% growth from 2020 revenues, including an expected $1.3 billion, or 3%, favorable impact from changes in foreign exchange rates compared to 2020. The midpoint of the updated guidance range for Adjusted diluted EPS⁽³⁾ reflects an 84% increase over 2020 actual results⁽⁸⁾, including an expected $0.09, 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 continues to assume no share repurchases in 2021.

Update to Assumptions Related to Comirnaty⁽¹⁾ Within 2021 Guidance

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

Revenues for Comirnaty(1)	Approximately $36 billion
	(previously approximately $33.5 billion)
Adjusted Income(3) Before Tax (IBT) Margin for Comirnaty(1)	High-20s as a Percentage of Revenues

The Comirnaty⁽¹⁾ revenue projection incorporated within Pfizer’s 2021 financial guidance includes approximately 2.3 billion doses that are expected to be delivered in fiscal 2021⁽⁵⁾ based on expected ordering patterns through the end of December for the U.S. and through the end of November for the rest of the world. Pfizer and BioNTech continue to expect to manufacture 3 billion doses in total by the end of December 2021. The difference between the number of doses expected to contribute to 2021 revenues versus the number of doses expected to be manufactured by year-end relates to anticipated international deliveries in December, which will be recorded as revenue in 2022 due to our international fiscal calendar⁽⁵⁾, and, to a lesser extent, doses expected to be produced but not yet delivered as of December 31, 2021.

Adjusted⁽³⁾ IBT margin guidance for Comirnaty⁽¹⁾ incorporates the expectation for revenues for the product, less anticipated Adjusted⁽³⁾ costs to manufacture, market and distribute Comirnaty⁽¹⁾, including applicable royalty expenses, and a 50% gross profit split with BioNTech, as well as shared R&D expenses related to ongoing Comirnaty⁽¹⁾ development efforts 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 Comirnaty⁽¹⁾

Pfizer is updating its financial guidance ranges for revenues and Adjusted diluted EPS⁽³⁾ excluding contributions from Comirnaty⁽¹⁾. Both financial guidance components were tightened within their previous guidance ranges primarily to reflect the passage of time and actual performance to date. In addition, guidance for revenues excluding Comirnaty⁽¹⁾ was tightened around the lower end of the previous range as a result of the Chantix recall and pause in global shipments.

Revenues	$45.0 to $46.0 billion
	(previously $45.0 to $47.0 billion)
Adjusted Cost of Sales(3) as a Percentage of Revenues	21% to 22%
Adjusted Diluted EPS(3)	$2.60 to $2.65
	(previously $2.55 to $2.65)

The midpoint of the revenue guidance range above reflects approximately 6% operational growth compared to 2020 when sales of Comirnaty⁽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 Comirnaty⁽¹⁾ reflects approximately 12% operational growth compared to the prior year⁽⁸⁾.

CAPITAL ALLOCATION

• During the first nine months of 2021, Pfizer paid $6.5 billion of cash dividends, or $1.17 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 November 2, 2021, Pfizer’s remaining share repurchase authorization is $5.3 billion. Current 2021 financial guidance does not reflect any share repurchases in 2021.
• Third-quarter 2021 diluted weighted-average shares outstanding used to calculate Reported⁽²⁾ and Adjusted⁽³⁾ diluted EPS was 5,725 million shares, an increase of 92 million shares, primarily due to shares issued for employee compensation programs, which resulted in a $0.02 reduction to both Reported⁽²⁾ and Adjusted⁽³⁾ diluted EPS compared to the prior-year quarter.

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

Third-quarter 2021 revenues totaled $24.1 billion, an increase of $13.8 billion, or 134%, compared to the prior-year quarter, reflecting operational growth of $13.4 billion, or 130%, as well as a favorable impact of foreign exchange of $421 million, or 4%.

Third-quarter 2021 operational growth was primarily driven by:

• Comirnaty⁽¹⁾, which contributed $13.0 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;
• Vyndaqel/Vyndamax, up 42% operationally, primarily driven by continued strong uptake of the transthyretin amyloid cardiomyopathy indication in the U.S., developed Europe and Japan;
• Inlyta globally, up 30% operationally, primarily reflecting continued 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 16%, primarily driven by strong demand across the metastatic and non-metastatic castration-resistant prostate cancer indications and the metastatic castration-sensitive prostate cancer indication;
• Ibrance outside of the U.S., up 9% 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; as well as
• Hospital products globally, which grew 29% operationally to $2.4 billion, primarily driven by Pfizer CentreOne, Pfizer’s contract manufacturing operation, reflecting certain Comirnaty-related manufacturing activities performed on behalf of BioNTech⁽¹⁾ and manufacturing of legacy Upjohn products for Viatris⁽⁶⁾, as well as growth from international markets, primarily driven by the anti-infectives portfolio; and
• Biosimilars, which grew 34% operationally to $575 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab), as well as continued growth from Retacrit (epoetin) in the U.S.,

partially offset primarily by lower revenues for:

• Chantix globally, down 97% operationally, driven by the voluntary recall across multiple markets and the 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;
• Prevnar family (Prevnar/Prevenar 13 & 20) globally, down 7% operationally, driven primarily by a 36% decline in the adult indication in the U.S. due to the ongoing prioritization of primary and booster vaccination campaigns for COVID-19 by U.S. health authorities and a later start to the flu season compared to the prior year, as well as the continued impact of the lower remaining unvaccinated eligible adult population and the June 2019 change to the Advisory Committee on Immunization Practices (ACIP) recommendation for the Prevnar 13 adult indication to shared clinical decision-making;
• Sutent globally, down 31% operationally, primarily reflecting lower volume demand in the U.S. resulting from its loss of exclusivity in August 2021;
• Xeljanz in the U.S., down 13%, reflecting the negative impact of a review by the U.S. Food and Drug Administration (FDA) which resulted in a Drug Safety Communication (DSC) related to Xeljanz and two competitors’ arthritis medicines in the same drug class, as well as an unfavorable change in channel mix toward lower-priced channels and continued investments to improve formulary positioning and unlock access to additional patient lives; and
• Enbrel internationally, down 12% operationally, primarily reflecting continued biosimilar competition.

GAAP Reported⁽²⁾ Income Statement Highlights

SELECTED REPORTED COSTS AND EXPENSES(2)
($ in millions)	Third-Quarter										Nine Months
							% Change										% Change
	2021			2020			Total	Oper.			2021			2020			Total		Oper.
Cost of Sales(2)	$	9,973		$	2,007		*	*			$	21,232		$	5,773		*		*
Percent of Revenues		41.4	%		19.5	%	N/A	N/A				36.8	%		19.1	%	N/A		N/A
SI&A Expenses(2)		2,905			2,658		9%	8%				8,617			7,858		10%		8%
R&D Expenses(2)		3,447			2,300		50%	49%				7,920			6,050		31%		30%
Total	$	16,326		$	6,965		*	*			$	37,770		$	19,681		92%		87%
Other (Income)/Deductions––net(2)	($1,696		)	$1,878			*	*			($3,697		)	$1,114			*		*
Effective Tax Rate on Reported Income(2)	(4.2		%)	(60.9		%)					7.5		%	6.7		%
* Indicates calculation not meaningful.

Third-quarter 2021 Cost of Sales⁽²⁾ as a percentage of revenues increased 21.9 percentage points compared with the prior-year quarter. The drivers for the increase include, among other things:

• an increase of approximately 21 percentage points associated with sales of Comirnaty⁽¹⁾, which includes a charge for the 50% gross profit split with BioNTech and applicable royalty expenses; and
• unfavorable changes in product mix, reflecting higher sales of lower margin products including revenues from the Pfizer CentreOne operation and lower sales of Chantix, partially offset by the favorable impact of higher alliance revenues.

SI&A Expenses⁽²⁾ increased 8% operationally in third-quarter 2021 compared with the prior-year quarter, primarily driven by incremental costs associated with the implementation of our cost-reduction and productivity initiatives, as well as increased product-related spending across multiple therapeutic areas and other costs associated with activity that is closer to pre-pandemic levels as compared to the prior-year quarter.

Third-quarter 2021 R&D Expenses⁽²⁾ increased 49% operationally compared with the prior-year quarter, which primarily reflects a $650 million up-front payment related to the global collaboration agreement with Arvinas, Inc. to develop and commercialize ARV-471 and increased investments across multiple therapeutic areas, including additional spending related to the development and at-risk manufacturing of the COVID-19 anti-viral programs.

Pfizer recorded $1.7 billion of other income––net⁽²⁾ in third-quarter 2021 compared with $1.9 billion of other deductions––net⁽²⁾ in third-quarter 2020. The period-over-period change was primarily driven by:

• net periodic benefit credits recorded in third-quarter 2021 versus net periodic benefit costs recorded in the prior-year quarter, primarily resulting from pension plan interim actuarial remeasurement gains and losses, respectively⁽⁸⁾;
• the non-recurrence of certain asset impairment charges that were incurred in third-quarter 2020; and
• net gains on equity securities in third-quarter 2021 versus net losses on equity securities recognized in the prior-year quarter.

Pfizer’s effective tax rate on Reported income⁽²⁾ 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 (GSK).

Adjusted⁽³⁾ Income Statement Highlights

SELECTED ADJUSTED COSTS AND EXPENSES(3)
($ in millions)	Third-Quarter														Nine Months
									% Change														% Change
	2021				2020				Total		Oper.				2021				2020				Total		Oper.
Adjusted Cost of Sales(3)	$	9,937			$	1,989			*		*				$	21,112			$	5,701			*		*
Percent of Revenues		41.2	%			19.4	%		N/A		N/A					36.6	%			18.9	%		N/A		N/A
Adjusted SI&A Expenses(3)		2,732				2,562			7%		5%					8,183				7,540			9%		7%
Adjusted R&D Expenses(3)		2,740				2,298			19%		19%					7,026				5,812			21%		20%
Total	$	15,409			$	6,849			*		*				$	36,320			$	19,053			91%		86%
Adjusted Other (Income)/Deductions––net(3)	($569		)		($397		)		43%		54%				($1,744		)		($1,101		)		58%		56%
Effective Tax Rate on Adjusted Income(3)	15.3		%		11.8		%								15.7		%		14.2		%
* Indicates calculation not meaningful.

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 July 28, 2021)

Product Developments

• Abrilada (adalimumab-afzb, biosimilar) — In September 2021, Pfizer received positive topline results from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with Abrilada and its reference product, Humira^®, both of which were administered with methotrexate in adult patients living with moderate to severe rheumatoid arthritis (RA). The study met its primary endpoint by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. Safety and immunogenicity were similar between both arms. Pfizer plans to launch citrate-free Abrilada in the U.S. as early as July 1, 2023 in accordance with the terms of agreement with the originator company.
• Chantix (varenicline) — In September 2021, Pfizer voluntarily recalled all lots of Chantix in the U.S. due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. Nitrosamines are common in water and foods and everyone is exposed to some level of nitrosamines. These impurities may 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.
• Cibinqo (abrocitinib)
  • In August 2021, Pfizer announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study evaluating abrocitinib 200 mg head-to-head with dupilumab 300 mg in adult patients on background topical therapy with moderate to severe atopic dermatitis (AD), met its co-primary and key secondary efficacy endpoints. The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies.
  • In September 2021, Pfizer announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Cibinqo for the treatment of moderate to severe AD in adults and adolescents aged 12 years and older, who are candidates for systemic therapy. Cibinqo is licensed in Great Britain in recommended doses of 100 mg and 200 mg.
  • In September 2021, Pfizer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Cibinqo for the treatment of moderate to severe AD in adults and adolescents aged 12 years and older, with inadequate response to existing therapies. Cibinqo will be available in Japan in doses of 100 mg and 200 mg.
  • In October 2021, Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib for marketing authorization to treat moderate to severe AD in adults who are candidates for systemic therapy.
• Comirnaty (BNT162b2, COVID-19 Vaccine, mRNA)
  • Clinical and Research Developments
    • In September 2021, Pfizer and BioNTech announced results from a Phase 2/3 trial of BNT162b2 showing a favorable safety profile and robust neutralizing antibody responses in children 5 through 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older.

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