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PFIZER REPORTS THIRD-QUARTER 2020 RESULTS

October 27, 2020 Off By BusinessWire

Third-Quarter 2020 Revenues of $12.1 Billion; Reported Diluted EPS⁽¹⁾ of $0.39, Adjusted Diluted EPS⁽²⁾ of $0.72
- 4% Operational Growth from Biopharma, Primarily Driven by the Ongoing Strong Performance of Vyndaqel/Vyndamax, Growth from our Leading Portfolio of Biosimilars, as Well as Continued Strength from Key Brands Including Eliquis, Ibrance, Xeljanz, Inlyta and Xtandi
Updated and Tightened Ranges for Certain Components of Total Company⁽³⁾ 2020 Financial Guidance, Including a Slight Increase to the Midpoint of Adjusted Diluted EPS⁽²⁾ Guidance Range
Reaffirmed All 2020 Financial Guidance Components for New Pfizer⁽⁴⁾ and Upjohn⁽⁵⁾ and the Projected Revenue CAGR of At Least 6% for New Pfizer⁽⁴⁾ Through 2025
COVID Vaccine Phase 2/3 Clinical Trial has Enrolled More Than 42,000 Participants, with Nearly 36,000 Having Received their Second Vaccination, as of October 26
Continue to Expect to Close the Upjohn Transaction with Mylan N.V. (Mylan) in the Fourth Quarter of 2020

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) reported financial results for third-quarter 2020 and updated and tightened certain components of Total Company⁽³⁾ 2020 financial guidance, which continues to reflect actual and anticipated business impacts from the novel coronavirus disease of 2019 (COVID-19) pandemic.

EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and Chief Executive Officer, stated, “As we enter the final stretch of what has been a historically challenging year for the world, I could not be more proud of the extraordinary effort, dedication and resolve shown by Pfizer colleagues to address the COVID-19 pandemic with unprecedented speed, while never compromising on their commitment to the patient-centered, science-driven standards that guide everything we do. I am more confident than ever in Pfizer’s future as we transition to a smaller, more agile, science-based pharmaceutical company with what we believe is an industry-leading innovative pipeline, a portion of which we were pleased to highlight at our recent investor day event.”

Frank D’Amelio, Chief Financial Officer and Executive Vice President, Global Supply, stated: “I am pleased with our performance so far this year, including our ability to maintain a steady supply of medicines to the patients who rely on them around the world during these uniquely challenging times. (Read more…) In the first nine months of the year, our Biopharma business grew 7% operationally, despite a COVID-19-related negative impact of approximately 2%, driven by the strong performance of many of our key brands. This performance adds to our confidence in our ability to achieve our expectation of at least a 6% compound annual revenue growth rate through 2025 for New Pfizer⁽⁴⁾.”

Results for the third quarter and the first nine months of 2020 and 2019⁽⁶⁾ are summarized below.

OVERALL RESULTS


($ in millions, except per share amounts)	Third-Quarter					Nine Months
	2020		2019		Change	2020		2019		Change
Revenues	$	12,131	$	12,680	(4%)	$	35,961	$	39,062	(8%)
Reported Net Income⁽¹⁾		2,194		7,680	(71%)		9,022		16,609	(46%)
Reported Diluted EPS⁽¹⁾		0.39		1.36	(71%)		1.60		2.92	(45%)
Adjusted Income⁽²⁾		4,071		4,214	(3%)		12,989		13,625	(5%)
Adjusted Diluted EPS⁽²⁾		0.72		0.75	(3%)		2.31		2.39	(4%)

REVENUES


($ in millions)	Third-Quarter						Nine Months
	2020		2019		% Change		2020		2019		% Change
	2020		2019		Total	Oper.	2020		2019		Total	Oper.
Biopharma	$	10,215	$	9,952	3%	4%	$	30,017	$	28,429	6%	7%
Upjohn		1,916		2,351	(18%)	(18%)		5,944		8,535	(30%)	(29%)
Consumer Healthcare⁽⁷⁾		—		377	(100%)	(100%)		—		2,098	(100%)	(100%)
Total Company	$	12,131	$	12,680	(4%)	(4%)	$	35,961	$	39,062	(8%)	(7%)

Beginning in 2020, Upjohn began managing Pfizer’s Meridian subsidiary, the manufacturer of EpiPen and other auto-injector products, and a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan). To facilitate comparison across periods, revenues and expenses associated with Meridian and Mylan-Japan are reported in Pfizer’s Upjohn business in all periods presented.

Acquisitions and other business development activities completed in 2019 and in the first nine months of 2020 impacted financial results in the periods presented⁽⁷⁾. 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 growth rates that exclude the impact of foreign exchange⁽⁸⁾.

2020 FINANCIAL GUIDANCE⁽⁹⁾

Financial guidance reflects management’s current expectations for operational performance, foreign exchange rates as well as various COVID-19-related uncertainties, primarily those related to the severity, duration and global macroeconomic impact of the pandemic.

Key guidance assumptions regarding these uncertainties broadly reflect an ongoing, gradual global recovery from the macroeconomic and healthcare impacts of the COVID-19 pandemic. These assumptions are guided by the trajectory of the pandemic’s impact on Pfizer’s business to date, which was less severe at its peak than originally anticipated, but is recovering at a somewhat slower pace than originally expected. Current guidance continues to assume no revenue contributions from a potential COVID-19 vaccine.

Pfizer updated and tightened the ranges for certain components of Total Company⁽³⁾ 2020 financial guidance, including a slight increase to the midpoint of the Adjusted Diluted EPS⁽²⁾ guidance range, and reaffirmed all 2020 financial guidance components for New Pfizer⁽⁴⁾ and Upjohn⁽⁵⁾. Updated 2020 financial guidance for Total Company⁽³⁾ is presented below.


Revenues	$48.8 to $49.5 billion
Revenues	(previously $48.6 to $50.6 billion)
Adjusted Cost of Sales⁽²⁾ as a Percentage of Revenues	20.2% to 20.7%
Adjusted Cost of Sales⁽²⁾ as a Percentage of Revenues	(previously 19.5% to 20.5%)
Adjusted SI&A Expenses⁽²⁾	$11.5 to $12.0 billion
Adjusted SI&A Expenses⁽²⁾	(previously $11.5 to $12.5 billion)
Adjusted R&D Expenses⁽²⁾	$8.8 to $9.1 billion
Adjusted R&D Expenses⁽²⁾	(previously $8.6 to $9.0 billion)
Adjusted Other (Income)/Deductions⁽²⁾	Approximately $1.0 billion of income
Adjusted Other (Income)/Deductions⁽²⁾	(previously approximately $800 million of income)
Effective Tax Rate on Adjusted Income⁽²⁾	Approximately 15.0%
Adjusted Diluted EPS⁽²⁾	$2.88 to $2.93
Adjusted Diluted EPS⁽²⁾	(previously $2.85 to $2.95)

Financial guidance for Adjusted diluted EPS⁽²⁾ continues to assume no share repurchases in 2020.

2020 Financial Guidance for New Pfizer⁽⁴⁾

Pfizer’s reaffirmed 2020 financial guidance for New Pfizer⁽⁴⁾ is presented below. New Pfizer⁽⁴⁾ financial guidance reflects the Biopharma business as it is presently being managed and assumes the pending Upjohn combination with Mylan was completed at the beginning of 2020.


Revenues	$40.8 to $42.4 billion
Adjusted IBT Margin⁽¹⁰⁾	Approximately 37.0%
Adjusted Diluted EPS⁽²⁾	$2.28 to $2.38
Operating Cash Flow	$10.0 to $11.0 billion

2020 Financial Guidance for Upjohn⁽⁵⁾

Pfizer’s reaffirmed 2020 financial guidance for Upjohn⁽⁵⁾ is presented below. Upjohn⁽⁵⁾ financial guidance reflects a full-year 2020 contribution from the Upjohn business as it is presently being managed.


Revenues	$8.0 to $8.5 billion
Adjusted EBITDA⁽¹¹⁾	$3.8 to $4.2 billion

CAPITAL ALLOCATION

During the first nine months of 2020, Pfizer paid $6.3 billion of dividends, composed of dividends of $0.38 per share of common stock in each of the first, second and third quarters of 2020.
No share repurchases have been completed to date in 2020. As of October 27, 2020, Pfizer’s remaining share repurchase authorization was $5.3 billion. No share repurchases are currently planned in 2020.
Third-quarter 2020 diluted weighted-average shares outstanding used to calculate Reported⁽¹⁾ and Adjusted⁽²⁾ diluted EPS was 5,633 million shares, a reduction of 16 million shares compared to the prior-year quarter primarily due to Pfizer’s share repurchase program, reflecting the impact of share repurchases during 2019, partially offset by shares issued for employee compensation programs.

QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2020 vs. Third-Quarter 2019)

Third-quarter 2020 revenues totaled $12.1 billion, a decrease of $549 million, or 4%, compared to the prior-year quarter, reflecting an operational decline of $444 million, or 4%, as well as the unfavorable impact of foreign exchange of $104 million, or 1%. Excluding the impact of Consumer Healthcare⁽⁷⁾, revenues declined 1% operationally compared to the prior-year quarter.

Impact of COVID-19 on Third-Quarter 2020 Revenues

Third-quarter 2020 revenues included an estimated unfavorable impact of approximately $500 million, or 4%, due to COVID-19, primarily driven by lower demand for certain products in China and unfavorable disruptions to wellness visits for patients in the U.S., which negatively impacted prescribing patterns for certain products, partially offset by increased adult uptake for Prevenar 13 in certain international markets resulting from greater vaccine awareness for respiratory illnesses, as well as the recovery of a portion of the missed doses of Prevnar 13 in the U.S. from second-quarter 2020.

Biopharma Revenue Highlights

Third-quarter 2020 Biopharma revenues totaled $10.2 billion, up 4% operationally, primarily driven by:

Vyndaqel/Vyndamax global revenues of $351 million, up 125% operationally, driven by:
- 101% growth in the U.S., driven by the launches of Vyndaqel in May 2019 and Vyndamax in September 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM); and
- 150% operational growth in international markets, primarily driven by the March 2019 launch of the ATTR-CM indication in Japan and the February 2020 approval of the ATTR-CM indication in the European Union (EU);
Biosimilars global revenues of $424 million, up 80% operationally, primarily driven by recent oncology biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) in the U.S. and other global markets, as well as continued growth from Retacrit (epoetin zeta), primarily in the U.S.;
Eliquis globally, up 9% operationally, primarily driven by continued increased adoption in non-valvular atrial fibrillation as well as oral anti-coagulant market share gains. In the U.S., strong volume growth was partially offset by a lower net price due to an increased impact from the Medicare “coverage gap” and unfavorable channel mix;
Prevenar 13 internationally, up 14% operationally, primarily reflecting continued strong pediatric uptake in China, as well as increased adult uptake in certain international markets resulting from greater vaccine awareness for respiratory illnesses, including specifically pneumococcal disease, due to the COVID-19 pandemic;
Ibrance in the U.S., up 9%, primarily driven by increased cyclin-dependent kinase (CDK) class penetration and Ibrance’s continued CDK market share leadership in metastatic breast cancer;
Xeljanz globally, up 10% operationally, primarily driven by:
- 6% growth in the U.S., reflecting higher volumes within the rheumatoid arthritis (RA) and psoriatic arthritis (PsA) indications driven by continued improvements in formulary access, partially offset by increased discounts from recently-signed contracts which were entered into in order to unlock access to additional patient lives; and
- 23% operational growth in international markets, primarily reflecting continued uptake in the RA indication and, to a lesser extent, the ulcerative colitis (UC) indication in certain developed markets;
Inlyta globally, up 41% operationally, primarily reflecting increased demand in the U.S. and certain developed international markets following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; and
Xtandi in the U.S., up 18%, primarily driven by continued strong demand in the metastatic and non-metastatic castration-resistant prostate cancer indications, as well as the metastatic castration-sensitive prostate cancer indication, which was approved in the U.S. in December 2019,

partially offset primarily by lower revenues for:

Prevnar 13 in the U.S., down 14%, primarily reflecting the unfavorable impact of timing associated with government purchases for the pediatric indication and the impact of the revised Advisory Committee on Immunization Practices (ACIP) recommendation for the adult indication to shared clinical decision making, which was published by the Centers for Disease Control and Prevention (CDC) in the Morbidity and Mortality Weekly Report in the fourth quarter of 2019, partially offset by the recovery of a portion of the missed doses from second-quarter 2020 resulting from COVID-19;
Enbrel internationally, down 21% operationally, primarily reflecting continued biosimilar competition in most developed Europe markets as well as in Japan and Brazil;
the Hospital business in emerging markets, down 11% operationally, primarily driven by lower demand for certain anti-infective products in China due to lower infection rates driven by fewer elective surgical procedures, shorter in-patient hospital stays and improved infection control compared to the prior-year quarter;
Ibrance in developed Europe, down 17% operationally, primarily reflecting continued strong volume growth, more than offset by pricing pressures in certain developed Europe markets; and
Chantix in the U.S., down 19%, primarily reflecting expected lower demand resulting from reduced doctor visits, including wellness visits when Chantix is typically prescribed, due to COVID-19.

Upjohn Revenue Highlights

Third-quarter 2020 Upjohn revenues totaled $1.9 billion, down 18% operationally, primarily driven by the following negative drivers, each of which was expected:

Significant volume declines for Lyrica in the U.S. due to multi-source generic competition that began in July 2019;
Lower revenues for Lipitor and Norvasc in China due to the impact of the volume-based procurement (VBP) program which was initially implemented in March 2019 and expanded nationwide in December 2019; and
Lower volume for Celebrex in Japan, resulting from generic competition which began in June 2020.

GAAP Reported⁽¹⁾ Income Statement Highlights

SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES⁽¹⁾


($ in millions)	Third-Quarter								Nine Months
	2020			2019			% Change		2020			2019			% Change
	2020			2019			Total	Oper.	2020			2019			Total	Oper.
Cost of Sales⁽¹⁾	$	2,529		$	2,602		(3%)	(4%)	$	7,188		$	7,611		(6%)	(4%)
Percent of Revenues		20.8	%		20.5	%	N/A	N/A		20.0	%		19.5	%	N/A	N/A
SI&A Expenses⁽¹⁾		3,016			3,260		(7%)	(7%)		8,919			10,110		(12%)	(11%)
R&D Expenses⁽¹⁾		2,360			2,283		3%	3%		6,216			5,827		7%	7%
Total	$	7,905		$	8,145		(3%)	(3%)	$	22,322		$	23,548		(5%)	(4%)

Other (Income)/Deductions––net⁽¹⁾	$	1,148		$	319		*	*	$	507		$	537		(6%)	(48%)
Effective Tax Rate on Reported Income⁽¹⁾		(1.2	%)		28.4	%				9.7	%		13.4	%

* indicates calculation not meaningful

Third-quarter 2020 Cost of Sales⁽¹⁾ as a percentage of revenues increased compared with the prior-year quarter, primarily due to unfavorable changes in product mix driven by declines in sales of Lyrica, Lipitor, Celebrex and Norvasc within our Upjohn business, as well as incremental costs incurred in response to COVID-19, partially offset by lower inventory write-offs.

SI&A Expenses⁽¹⁾ decreased in third-quarter 2020 compared with the prior-year quarter, primarily driven by the impact of the July 31, 2019 completion of the Consumer Healthcare joint venture transaction with GSK⁽⁷⁾ (Consumer Healthcare JV) and a reduction in spending associated with corporate enabling functions, as well as lower spending on sales and marketing activities due to the impact of the COVID-19 pandemic.

Third-quarter 2020 R&D Expenses⁽¹⁾ increased compared with the prior-year quarter, which primarily reflects, among other things, higher spending on Pfizer’s efforts to develop potential vaccines and therapeutics to help prevent and treat COVID-19, partially offset by the non-recurrence of an upfront payment associated with the acquisition of Therachon Holding AG in July 2019.

Pfizer recorded higher other deductions––net⁽¹⁾in third-quarter 2020 compared with the prior-year quarter, primarily driven by a $900 million asset impairment charge recorded in third-quarter 2020 related to in-process R&D acquired in connection with Pfizer’s 2019 acquisition of Array BioPharma Inc., partially offset by income from the Consumer Healthcare JV⁽⁷⁾.

Pfizer’s effective tax rate on Reported income⁽¹⁾ for third-quarter 2020 compared to the prior-year quarter was favorably impacted primarily by the non-recurrence of the tax expense recorded in third-quarter 2019 on the gain related to the completion of the Consumer Healthcare JV⁽⁷⁾ as well as a favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business.

Adjusted⁽²⁾ Income Statement Highlights

SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES⁽²⁾


($ in millions)	Third-Quarter								Nine Months
	2020			2019			% Change		2020			2019			% Change
	2020			2019			Total	Oper.	2020			2019			Total	Oper.
Adjusted Cost of Sales⁽²⁾	$	2,502		$	2,459		2%	1%	$	7,088		$	7,430		(5%)	(3%)
Percent of Revenues		20.6	%		19.4	%	N/A	N/A		19.7	%		19.0	%	N/A	N/A
Adjusted SI&A Expenses⁽²⁾		2,869			3,196		(10%)	(10%)		8,421			9,971		(16%)	(15%)
Adjusted R&D Expenses⁽²⁾		2,354			1,940		21%	21%		5,976			5,458		9%	10%
Total	$	7,724		$	7,595		2%	2%	$	21,485		$	22,859		(6%)	(5%)

Adjusted Other (Income)/Deductions––net⁽²⁾	($	351)		$	32		*	*	($	898)		($	203)		*	*
Effective Tax Rate on Adjusted Income⁽²⁾		12.9	%		15.3	%				14.1	%		15.8	%

* Indicates calculation not meaningful.

A full reconciliation of Reported⁽¹⁾ to Adjusted⁽²⁾ 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, 2020)

Product Developments

Daurismo (glasdegib) — Pfizer announced today that it has stopped the Intensive cohort of the Phase 3 BRIGHT AML 1019 trial evaluating Daurismo in combination with cytarabine and daunorubicin in adults with previously untreated acute myeloid leukemia (AML). The results of an interim analysis reviewed by an independent Data Monitoring Committee (DMC) showed the trial was unlikely to achieve statistical significance in the primary endpoint of overall survival. No new safety signals were observed. Results from the trial are currently being analyzed and will be shared with the scientific community at a later date. The results from the BRIGHT AML 1019 trial do not impact the approved indication for Daurismo in combination with low-dose cytarabine for the treatment of newly diagnosed AML in the U.S., EU and Canada. Pfizer has notified health authorities and trial investigators of the interim findings and the decision to discontinue the trial.
Ibrance (palbociclib) — In October 2020, the German Breast Group and Pfizer announced that the collaborative Phase 3 PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer who have residual invasive disease after completing neoadjuvant chemotherapy. No unexpected safety signals were observed. Detailed findings from PENELOPE-B will be presented at an upcoming medical congress.
Lorbrena (lorlatinib) — In August 2020, Pfizer announced that the Phase 3 CROWN study of lorlatinib in people with previously untreated advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer met its primary endpoint by demonstrating significantly improved progression-free survival, as compared to Xalkori (crizotinib). The results were reviewed by an independent DMC at a planned interim analysis. The safety profile for lorlatinib and crizotinib were consistent with what has been previously seen in clinical trials. The results from CROWN were presented at the European Society for Medical Oncology Presidential Symposium in September 2020, and the data are submitted for regulatory review under the Food and Drug Administration (FDA)’s Real Time Oncology Review pilot project.
Xalkori (crizotinib) — In September 2020, Pfizer announced that the FDA has accepted and granted priority review to a sNDA for Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is ALK-positive. If approved, Xalkori would be the first biomarker-driven therapy for this type of pediatric lymphoma. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2021.
Xeljanz (tofacitinib) — In September 2020, Pfizer announced that the FDA approved Xeljanz for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). This approval makes Xeljanz the first and only Janus kinase (JAK) inhibitor approved in the U.S. for the treatment of pcJIA.

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.

BNT162 COVID-19 Vaccine Development Program
- Clinical Updates
  - In September 2020, Pfizer and BioNTech SE (BioNTech) expanded the enrollment of their Phase 3 COVID-19 vaccine trial to up to approximately 44,000 participants from the initial target of up to 30,000 participants. The expansion allows the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable human immunodeficiency virus (HIV), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data. Additionally, in October 2020, Pfizer and BioNTech received permission from the FDA to enroll adolescents as young as 12 years of age.
  - In August 2020, Pfizer and BioNTech shared additional safety and immunogenicity data from the U.S. Phase 1 trial for the BNT162b2 vaccine candidate. At 7 days after a second dose of 30μg, BNT162b2 elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in both younger and older adults. Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.
- Commercial Updates
  - In September 2020, Pfizer and BioNTech announced that they had concluded exploratory talks with the European Commission (EC) for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to EU Member States, with an option for an additional 100 million doses. Deliveries would begin by the end of 2020, subject to clinical success and regulatory authorization.

Contacts

Media
Amy Rose 212.733.7410

Investors
Chuck Triano 212.733.3901

Bryan Dunn 212.733.8917

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