(State or other | (Commission File | (I.R.S. Employer |
jurisdiction of | Number) | Identification No.) |
incorporation) | ||
(Zip Code) | ||
Securities registered pursuant to Section 12(b) of the Act: | ||||
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Exhibit Number | Exhibit Description | |
Press Release of Pfizer Inc. dated April 28, 2020, reporting Pfizer’s financial results for the first quarter of 2020. | ||
104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. | |
EXHIBIT INDEX | ||
Exhibit No. | Description | |
Press Release of Pfizer Inc. dated April 28, 2020, reporting Pfizer’s financial results for the first quarter of 2020. | ||
104 | Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document. | |
PFIZER INC. | ||
By: | /s/ Margaret M. Madden | |
Margaret M. Madden | ||
Senior Vice President and Corporate Secretary | ||
Chief Governance Counsel | ||

▪ | First-Quarter 2020 Revenues of $12.0 Billion, Reflecting 7% Operational Decline; Excluding the Impact from Consumer Healthcare(1), Revenues Declined 1% Operationally |
– | 12% Operational Growth from Biopharma, Primarily Driven by Eliquis, Vyndaqel/Vyndamax, Ibrance and Inlyta as well as 15% Operational Growth in Emerging Markets |
– | 37% Operational Decline from Upjohn, Primarily Due to U.S. Loss of Exclusivity of Lyrica in 2019 and Declines from Lipitor and Norvasc in China due to the Volume-Based Procurement (VBP) Program |
▪ | First-Quarter 2020 Reported Diluted EPS(2) of $0.61, Adjusted Diluted EPS(3) of $0.80 |
▪ | Reaffirmed 2020 Financial Guidance for Revenues and Adjusted Diluted EPS(3), Absorbing Unfavorable Changes in Foreign Exchange Rates and Reflecting Certain Anticipated Impacts from the COVID-19 Pandemic |
▪ | Company Details COVID-19 Business Impact and Response to Pandemic, Including Researching Potential Therapeutics and Vaccines |
OVERALL RESULTS | |||||
($ in millions, except per share amounts) | First-Quarter | ||||
2020 | 2019 | Change | |||
Revenues | $ 12,028 | $ 13,118 | (8%) | ||
Reported Net Income(2) | 3,401 | 3,884 | (12%) | ||
Reported Diluted EPS(2) | 0.61 | 0.68 | (10%) | ||
Adjusted Income(3) | 4,514 | 4,891 | (8%) | ||
Adjusted Diluted EPS(3) | 0.80 | 0.85 | (5%) | ||
REVENUES | ||||||
($ in millions) | First-Quarter | |||||
2020 | 2019 | % Change | ||||
Total | Oper. | |||||
Biopharma | $ 10,007 | $ 9,045 | 11% | 12% | ||
Upjohn | 2,022 | 3,214 | (37%) | (37%) | ||
Consumer Healthcare(1) | — | 858 | (100%) | (100%) | ||
Total Company | $ 12,028 | $ 13,118 | (8%) | (7%) | ||
▪ | Patient visits with physicians, vaccinations and elective surgical procedures will rebound starting in second-half 2020 and align more closely with historical levels; |
▪ | New-to-brand prescription trends for certain key products and vaccination rates will resume on a similar trajectory to what was seen in 2019, beginning in second-half 2020; |
▪ | Access to prescribers for sales force colleagues is restored in second-half 2020; |
▪ | Clinical trial enrollment, including new study starts, will fully resume in second-half 2020; |
▪ | Pfizer’s manufacturing and supply chain activities are not materially disrupted; and |
▪ | Pfizer’s investments in potential treatments and a potential vaccine for COVID-19 continue throughout 2020. |
▪ | Guidance range for revenues was reaffirmed at $48.5 to $50.5 billion, absorbing a $0.6 billion unfavorable impact from changes in foreign exchange rates in relation to the U.S. dollar since mid-January 2020, primarily the weakening of the Brazilian real, the euro, the Mexican peso and the Chinese yuan. |
▪ | Guidance range for Adjusted cost of sales(3) as a percentage of revenues was lowered by 400 basis points to a range of 19.5% to 20.5%, primarily to reflect the favorable impact of product mix and other efficiencies. |
▪ | Guidance range for Adjusted SI&A expenses(3) was lowered by $500 million to a range of $11.5 to $12.5 billion, primarily to reflect incremental cost-savings opportunities, primarily reductions in indirect SI&A spend associated with corporate enabling functions, as well as actual and anticipated COVID-19-related spending reductions. |
▪ | Guidance range for Adjusted R&D expenses(3) was increased by $500 million to a range of $8.6 to $9.0 billion, solely to reflect incremental investments Pfizer anticipates making in 2020 to combat the COVID-19 pandemic, including development of potential anti-viral treatments and a potential vaccine, as well as the evaluation of existing Pfizer medicines, which are the subject of novel research projects for investigation in COVID-19 patients. |
▪ | Guidance range for Adjusted diluted EPS(3) was reaffirmed at $2.82 to $2.92, absorbing a $0.04 unfavorable impact from changes in foreign exchange rates since mid-January 2020. |
Revenues | $48.5 to $50.5 billion |
Adjusted Cost of Sales(3) as a Percentage of Revenues | 19.5% to 20.5% |
(previously 19.9% to 20.9%) | |
Adjusted SI&A Expenses(3) | $11.5 to $12.5 billion |
(previously $12.0 to $13.0 billion) | |
Adjusted R&D Expenses(3) | $8.6 to $9.0 billion |
(previously $8.1 to $8.5 billion) | |
Adjusted Other (Income)/Deductions(3) | Approximately $800 million of income |
Effective Tax Rate on Adjusted Income(3) | Approximately 15.0% |
Adjusted Diluted EPS(3) | $2.82 to $2.92 |
Revenues | $40.7 to $42.3 billion |
Adjusted IBT Margin(9) | Approximately 37.0% |
Adjusted Diluted EPS(3) | $2.25 to $2.35 |
Operating Cash Flow | $10.0 to $11.0 billion |
(previously $11.0 to $12.0 billion) | |
Revenues | $8.0 to $8.5 billion |
Adjusted EBITDA(11) | $3.8 to $4.2 billion |
▪ | During the first three months of 2020, Pfizer paid $2.1 billion of dividends, or $0.38 per share of common stock. |
▪ | No share repurchases have been completed to date in 2020. As of April 28, 2020, Pfizer’s remaining share repurchase authorization was $5.3 billion. No share repurchases are currently planned in 2020. |
▪ | The first-quarter 2020 diluted weighted-average shares used to calculate earnings per common share was 5,613 million shares, a reduction of 137 million shares compared to first-quarter 2019. |
▪ | Eliquis globally, up 29% operationally, primarily driven by continued increased adoption in non-valvular atrial fibrillation as well as oral anti-coagulant market share gains. U.S. growth was also favorably impacted by COVID-19-related wholesaler buying patterns, partially offset by a lower net price; |
▪ | the Hospital business globally, up 11% operationally, driven by the U.S. and emerging markets, primarily due to continued uptake of anti-infective products in China and continued growth from Panzyga following its November 2018 U.S. launch, as well as increased demand in the U.S. for certain anti-infectives and other sterile injectable products utilized in the intubation and ongoing treatment of mechanically-ventilated COVID-19 patients; |
▪ | Vyndaqel/Vyndamax global revenues were $231 million, driven by: |
– | the U.S. launches of Vyndaqel in May 2019 and Vyndamax in September 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM); and |
– | 156% operational growth in international markets, primarily driven by the March 2019 launch of the ATTR-CM indication in Japan; |
▪ | Ibrance in the U.S. and emerging markets, collectively up 17% operationally, primarily driven by: |
– | 15% growth in the U.S., primarily driven by increased cyclin-dependent kinase (CDK) class penetration and Ibrance’s continued CDK market share leadership in its approved metastatic breast cancer indications; and |
– | 37% operational growth in emerging markets, reflecting continued strong volume growth in most markets; |
▪ | Prevenar 13 internationally, up 11% operationally, primarily reflecting continued pediatric uptake in China as well as the overall favorable impact of timing associated with government purchases for the pediatric indication in certain emerging markets; |
▪ | Inlyta in the U.S., up 255%, primarily reflecting increased uptake resulting from the second-quarter 2019 U.S. Food and Drug Administration (FDA) approvals for combinations of certain immune checkpoint inhibitors plus Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; |
▪ | Retacrit in the U.S., up 363%, primarily reflecting continued uptake for the only biosimilar short-acting erythropoiesis-stimulating agent in the market; |
▪ | Xeljanz in international markets, up 38% operationally, primarily reflecting continued uptake in the rheumatoid arthritis indication and, to a lesser extent, from the recent launch of the ulcerative colitis indication in certain developed markets; and |
▪ | Xtandi in the U.S., up 25%, primarily driven by continued strong demand in the metastatic and non-metastatic castration-resistant prostate cancer indications and, to a lesser extent, uptake from the metastatic castration-sensitive prostate cancer indication, which was approved in the U.S. in December 2019; |
▪ | Enbrel internationally, down 21% operationally, primarily reflecting continued biosimilar competition in most developed Europe markets as well as in Brazil and Japan; |
▪ | Prevnar 13 in the U.S., down 10%, primarily reflecting the unfavorable impact of timing associated with government purchases for the pediatric indication compared with the prior-year quarter; |
▪ | Ibrance in developed Europe, down 11% operationally, primarily reflecting continued strong demand, more than offset by pricing pressures in certain markets; and |
▪ | Xeljanz in the U.S., down 4%, reflecting continued strong demand across all approved indications, more than offset by a lower net price due to higher rebating from commercial contracts signed in 2019 as well as a temporary lowering of wholesaler inventories in first-quarter 2020. Wholesaler inventory levels for Xeljanz were restored to normal levels in early April 2020, during Pfizer’s second quarter, as underlying volume demand has remained consistently strong. |
SELECTED TOTAL COMPANY REPORTED COSTS AND EXPENSES(2) | ||||||
($ in millions) | First-Quarter | |||||
2020 | 2019 | % Change | ||||
Total | Oper. | |||||
Cost of Sales(2) | $ 2,378 | $ 2,433 | (2%) | (3%) | ||
Percent of Revenues | 19.8 | % | 18.5 | % | N/A | N/A |
SI&A Expenses(2) | 2,873 | 3,339 | (14%) | (13%) | ||
R&D Expenses(2) | 1,724 | 1,703 | 1% | 1% | ||
Total | $ 6,975 | $ 7,474 | (7%) | (7%) | ||
Other (Income)/Deductions––net(2) | 221 | 92 | 140% | 140% | ||
Effective Tax Rate on Reported Income(2) | 12.2 | % | 10.0 | % | ||
▪ | net losses on equity securities in first-quarter 2020 compared with net gains on equity securities in first-quarter 2019; |
▪ | an unfavorable change in the fair value of contingent consideration; and |
▪ | higher interest expense, |
▪ | lower asset impairment charges; |
▪ | the non-recurrence of net losses on the early retirement of certain outstanding debt securities recorded in first-quarter 2019; and |
▪ | lower business and legal entity alignment costs. |
SELECTED TOTAL COMPANY ADJUSTED COSTS AND EXPENSES(3) | ||||||
($ in millions) | First-Quarter | |||||
2020 | 2019 | % Change | ||||
Total | Oper. | |||||
Adjusted Cost of Sales(3) | $ 2,350 | $ 2,415 | (3%) | (4%) | ||
Percent of Revenues | 19.5 | % | 18.4 | % | N/A | N/A |
Adjusted SI&A Expenses(3) | 2,745 | 3,311 | (17%) | (16%) | ||
Adjusted R&D Expenses(3) | 1,727 | 1,693 | 2% | 2% | ||
Total | $ 6,821 | $ 7,419 | (8%) | (8%) | ||
Adjusted Other (Income)/Deductions––net(3) | (186 | ) | (135 | ) | 37% | 38% |
Effective Tax Rate on Adjusted Income(3) | 15.0 | % | 15.2 | % | ||
▪ | Bavencio (avelumab) |
– | In April 2020, EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, and Pfizer announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for Bavencio for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma. The FDA granted Breakthrough Therapy Designation to Bavencio for this indication, and the sBLA is being reviewed by the FDA under its Real-Time Oncology Review pilot program. |
– | In March 2020, EMD Serono and Pfizer announced that the Phase 3 JAVELIN Head and Neck 100 study evaluating avelumab in addition to chemoradiotherapy (CRT) versus standard-of-care CRT in patients with untreated, locally advanced squamous cell carcinoma of the head and neck was terminated based on the recommendation of the independent Data Monitoring Committee as the study was unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival |
▪ | Braftovi (encorafenib) -- In April 2020, Pfizer announced that the FDA approved Braftovi in combination with Erbitux®(12) (cetuximab) for the treatment of adult patients with metastatic colorectal cancer with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy. |
▪ | Eucrisa/Staquis (crisaborole ointment, 2%) |
– | In March 2020, the European Commission (EC) approved Staquis for treatment of mild to moderate atopic dermatitis (AD) in adults and pediatric patients from 2 years of age with 40% or less body surface area affected. |
– | In March 2020, Pfizer announced that the FDA approved its supplemental New Drug Application for Eucrisa, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate AD. Eucrisa was previously approved in the U.S. for use in adults and children 2 years of age and older. This supplemental approval makes Eucrisa the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age. |
▪ | Ruxience (rituximab) -- In April 2020, Pfizer announced that the EC approved Ruxience, a biosimilar to MabThera®(13), for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris. |
▪ | Steglatro (ertugliflozin) -- In April 2020, Merck & Co., Inc. (Merck), known as MSD outside the U.S. and Canada, and Pfizer reported top-line results for the Phase 3 VERTIS CV cardiovascular (CV) outcomes trial for Steglatro, an oral sodium-glucose cotransporter 2 inhibitor, which achieved its primary endpoint of non-inferiority for major adverse CV events (MACE) compared to placebo in patients with type 2 diabetes mellitus and established atherosclerotic CV disease. MACE was defined as time to the first event of CV death, nonfatal myocardial infarction or nonfatal stroke. The key secondary endpoints of superiority for Steglatro versus placebo for time to composite of CV death or hospitalization for heart failure, CV death alone and the composite of renal death, dialysis/transplant or doubling of serum creatinine from baseline were not met. While not a pre-specified hypothesis for statistical testing, a reduction in hospitalization for heart failure was observed with Steglatro. The safety profile of Steglatro was consistent with that reported in previous studies. Detailed results of VERTIS CV are scheduled to be presented on June 16, 2020 at the virtual American Diabetes Association’s 80th Scientific Sessions. |
▪ | Vyndaqel (tafamidis) -- In February 2020, Pfizer announced that the EC approved Vyndaqel, a once-daily 61 mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with ATTR-CM. Vyndaqel is the first and only treatment approved in the European Union (EU) for patients with ATTR-CM. In 2011, the tafamidis meglumine 20 mg capsule formulation of Vyndaqel was approved in the EU for transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay |
▪ | Xtandi (enzalutamide) -- In February 2020, Astellas Pharma Inc. and Pfizer announced results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated Xtandi plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC). The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with Xtandi plus ADT. OS was a key secondary endpoint of the trial. In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER. Detailed efficacy and safety results from the final PROSPER OS analysis will be shared at a later date. |
▪ | Abrocitinib (PF-04965842) -- In March 2020, Pfizer announced positive top-line results from the Phase 3 JADE COMPARE study. The study met its co-primary efficacy endpoints and evaluated the safety and efficacy of abrocitinib, an investigational oral once-daily Janus kinase (JAK) 1 inhibitor, in adults with moderate-to-severe AD who were also on background topical therapy. The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo. These data, along with other results from other pivotal trials, MONO-1 and MONO-2, are expected to support filings with regulatory agencies, starting with the FDA, planned for later this year. |
▪ | PF-06482077 (20-Valent Pneumococcal Conjugate Vaccine) -- In March 2020, Pfizer announced top-line results from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of PF-06482077 in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in PF-06482077 in adults 60 years of age and older at one month after vaccination were met for all serotypes in common with licensed Prevnar 13 (13-valent pneumococcal conjugate vaccine [Diphtheria CRM197 Protein]) and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23); one of the new seven serotypes missed noninferiority criteria by a small margin. Secondary immunogenicity objectives for adults 18-59 years old compared to those 60-64 years old met non-inferiority for all 20 serotypes. The safety objectives were met in adults 18 years of age or older, demonstrating that the safety and tolerability of PF-06482077 were comparable to licensed pneumococcal vaccines. Based on prior discussions with regulators, these data are expected to meet licensure criteria. Pfizer will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been |
▪ | PF-06928316 (Respiratory Syncytial Virus (RSV) Vaccine) -- In April 2020, positive top-line results were achieved for a Phase 2b proof-of-concept study, which evaluated the safety, tolerability and immunogenicity of PF-06928316 in vaccinated pregnant women ages 18 through 49 and their infants. Detailed results from this study will be shared at a future medical conference. The Phase 3 program for PF-06928316 is projected to begin in the coming months. |
▪ | Tanezumab (PF-04383119) -- In March 2020, Pfizer and Eli Lilly and Company (Lilly) announced that the FDA accepted for review a Biologics License Application for tanezumab 2.5 mg administered subcutaneously, which is being evaluated for patients with chronic pain due to moderate-to-severe osteoarthritis (OA) who have experienced inadequate pain relief with other analgesics. The Prescription Drug User Fee Act goal date for a decision by the FDA is in December 2020. In its filing acceptance letter, the FDA stated that it was planning to hold an Advisory Committee meeting to discuss this application. In addition, the European Medicines Agency validated for review a Marketing Authorisation Application for tanezumab 2.5 mg administered subcutaneously for adult patients with moderate-to-severe chronic pain associated with OA for whom treatment with nonsteroidal anti-inflammatory drugs and/or an opioid is ineffective, not tolerated or inappropriate. |
▪ | Since March 2020, Pfizer has made a series of announcements related to the COVID-19 pandemic: |
– | In April 2020, Pfizer announced important advances in the battle against the COVID-19 pandemic, including: |
◦ | Antiviral Compound Screening: Pfizer confirmed a lead compound and analogues to be potent inhibitors of the SARS-CoV-2 3C-like protease, based on the results of initial screening assays. In addition, preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Consequently, Pfizer will continue to perform pre-clinical confirmatory studies, including further antiviral profiling and assessment of the suitability of the lead molecule for IV administration clinically. In parallel, the company is also investing in materials that aim to accelerate the start of a potential clinical study of the lead molecule to third-quarter 2020, three or more months in advance of earlier estimates, subject to positive completion of the pre-clinical confirmatory studies. |
◦ | Applying Pfizer’s Long History in Vaccine R&D Expertise to Collaborate with BioNTech: Pfizer and BioNTech entered into a global collaboration agreement to co-develop a potential first-in-class, mRNA-based coronavirus vaccine program, BNT162, aimed at preventing COVID-19 |
◦ | Analysis of Azithromycin as an Agent with Antiviral Activity: In an effort to share information that could benefit COVID-19 mitigation efforts, Pfizer researchers published a review in Clinical Pharmacology and Therapeutics, which assesses published in vitro and clinical data regarding azithromycin as an agent with antiviral properties. This open access review may serve to facilitate the use of azithromycin in future research on COVID-19. Azithromycin is not approved for the treatment of viral infections. |
◦ | Studying Pfizer’s Existing Medicines for Critical Patient Populations in Need: |
• | Pfizer and the Liverpool School of Tropical Medicine’s Respiratory Infection Clinical Research Group initiated two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2. The studies (SAFER study (SARS-CoV-2 Acquisition in Frontline Health Care Workers – Evaluation to Inform Response) and the FASTER study (Facilitating A SARS CoV-2 Test for Rapid triage)) will help demonstrate whether patients infected with COVID-19 have a higher risk of also developing pneumococcal pneumonia and if having both infections leads to more severe disease and poorer outcomes. The SAFER study will enroll 100 healthcare workers at the Royal Liverpool Hospital and |
• | Pfizer is in discussions with other institutions about studies involving its immuno-kinase portfolio. This research is based on the hypothesis that modulation of the immune response could mitigate systemic and alveolar inflammation in patients with COVID-19-related pneumonia by inhibiting essential cytokine signaling involved in immune-mediated inflammatory response that could lead to damage of the lungs, resulting in acute respiratory distress syndrome in patients with COVID-19-related pneumonia. |
– | In April 2020, Pfizer and The Pfizer Foundation announced the commitment of $40 million in medical and charitable cash grants to help combat the health effects of the COVID-19 pandemic in the U.S. and around the world. The donation addresses the urgent needs of partners who are working to slow the spread of the virus within communities and strengthen vulnerable healthcare systems against future public health threats. Pfizer is also responding to patient and healthcare provider needs during this unprecedented time by evolving its U.S. Patient Assistance Program and donating additional critical medicines and vaccines in the U.S. and around the world. The Pfizer Foundation is a charitable organization established by Pfizer Inc. It is a separate legal entity from Pfizer Inc. with distinct legal restrictions. |
– | In April 2020, Pfizer, Merck and Lilly announced medical service volunteer programs to enable employees who are licensed medical professionals to aid in the fight against COVID-19. Pfizer created a new Global COVID-19 Medical Service Program that empowers medical colleagues to provide diagnostic, treatment and public health support in the battle against COVID-19. Licensed medical professionals who feel duty-bound to provide their services during this crisis will now have a way to engage in the fight against COVID-19. Colleagues will continue to receive their pay, benefits and be able to return to their position upon completion of service. |
– | In March 2020, Pfizer announced that, given the unique circumstances of the COVID-19 pandemic and Pfizer’s responsibility to prioritize the health and safety of colleagues and invited guests, the company will reschedule its Investor Day that had been planned for March 31, 2020 to a later date. At this point, there is no timetable for rescheduling the event. Pfizer will work within the context of appropriate guidance from health authorities to determine a future date. |
– | In March 2020, Pfizer issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19. Pfizer is making five promises that will help scientists more rapidly bring forward therapies and vaccines to protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises. |
1. | Sharing tools and insights: With very little known about this virus, many are working to develop cell-based assays, viral screening, serological assays and translational models to test potential therapies and vaccines. Pfizer is committed to making the vital tools it develops available on an open source platform to the broader scientific community and to sharing the data and learnings gained with other companies in real time to rapidly advance therapies and vaccines to patients. |
2. | Marshalling Pfizer’s people: Human capital is Pfizer’s most valuable resource. Pfizer has created a SWAT team of leading virologists, biologists, chemists, clinicians, epidemiologists, vaccine experts, pharmaceutical scientists and other key experts to focus solely on addressing this pandemic. This team is applying their passion, commitment and expertise to a single focus of accelerating the discovery and development process that will deliver therapies and vaccines to patients as soon as possible. |
3. | Applying Pfizer’s drug development expertise: Many smaller biotech companies are screening compounds or existing therapies for activity against the virus causing COVID-19, but some lack the experience in late stage development and navigating the complex regulatory systems. Pfizer is committed to sharing its clinical development and regulatory expertise to support the most promising candidates these companies bring forward. |
4. | Offering Pfizer’s manufacturing capabilities: Once a therapy or vaccine is approved it will need to be rapidly scaled and deployed around the world to put an end to this pandemic. As one of the largest manufacturers of vaccines and therapeutics, Pfizer is committed to using any excess manufacturing capacity and to potentially shifting production to support others in rapidly getting these life-saving breakthroughs into the hands of patients as quickly as possible. |
5. | Improving future rapid response: Finally, to address future global health threats, Pfizer is reaching out to federal agencies including the National Institutes of Health, the National Institute of Allergy and Infectious Diseases, and the Centers for Disease Control and Prevention to build a cross-industry rapid response team of scientists, clinicians and technicians able to move into action immediately when future epidemics surface. |
▪ | Since February 2020, Pfizer announced the election of three new members to its Board of Directors, including: |
– | In April 2020, Dr. Susan Desmond-Hellmann was elected to Pfizer’s Board of Directors, effective immediately, and was appointed to the Governance & Sustainability Committee and the Science and Technology Committee of the Board. |
– | In March 2020, Dr. Susan Hockfield was elected to Pfizer’s Board of Directors, effective immediately, and was appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of the Board. |
– | In February 2020, James Quincey was elected to Pfizer’s Board of Directors, effective immediately, and was appointed to the Compensation Committee and the Science and Technology Committee of the Board. |
▪ | Since February 2020, Pfizer and Mylan have made a series of announcements regarding the pending combination of Mylan with Upjohn, a division of Pfizer, into a new global pharmaceutical company, Viatris, including: |
– | In April 2020, the EC approved the combination of Mylan and Upjohn, conditioned upon the completion of the sale of certain of Mylan’s products in Europe. |
– | In March 2020, Pfizer and Mylan announced that due to the unprecedented circumstances surrounding the COVID-19 pandemic, including associated delays in the regulatory review process, the proposed transaction is now anticipated to close in the second half of 2020. There are no additional changes to the previously announced terms or plans regarding the transaction. Pfizer and Mylan remain highly confident in the benefits of the pending transaction to their respective shareholders and other stakeholders. Mylan, Pfizer and Upjohn are working closely on integration planning and are making significant progress toward Day 1 readiness while continuing to progress toward a successful transaction close. Mylan’s extraordinary general meeting of shareholders to approve certain matters in connection with the transaction was rescheduled from April 27, 2020, to June 30, 2020, and will be hosted in conjunction with Mylan’s annual general meeting of shareholders. |
– | In February 2020, Pfizer and Mylan announced that Sanjeev Narula, current chief financial officer (CFO) of Upjohn was named incoming CFO of Viatris. As the Viatris CFO, Mr. Narula will report to Michael Goettler, who was previously announced as incoming CEO of Viatris. The Mylan and Upjohn teams will continue to work together over the coming months to fill additional leadership positions and further its comprehensive integration planning efforts. Mylan and Upjohn will continue to operate as independent organizations under their existing organization structures until the transaction closes. |
– | In February 2020, Pfizer and Mylan announced the remaining appointees to the inaugural 13-member Board of Directors for Viatris. In addition to the previously announced Pfizer-designated appointments of Ian Read and Jim Kilts, Pfizer has appointed current Pfizer board member W. Don Cornwell, who will resign from the Pfizer board to serve as a director of Viatris upon the close of the transaction. Additionally, Mylan has appointed eight of its own directors to serve on the Viatris Board of Directors, including JoEllen Lyons Dillon, Neil Dimick, Melina Higgins, Harry A. Korman, Rajiv Malik, Richard A. Mark, Mark W. Parrish and Pauline van der Meer Mohr. As previously announced, the Board of Directors of Viatris will also include Viatris Executive Chairman Robert J. Coury and Viatris CEO Michael Goettler. |
(1) | The following acquisitions and divestitures impacted financial results for the periods presented: |
▪ | On July 31, 2019, Pfizer and GlaxoSmithKline plc (GSK) completed a transaction that combined the two companies’ respective consumer healthcare businesses into a joint venture (JV), operating under the GSK Consumer Healthcare name. In exchange for contributing its Consumer Healthcare business to the JV, Pfizer received a 32% equity stake in the JV and GSK owns the remaining 68% of the JV. Upon the closing of the transaction, Pfizer deconsolidated its Consumer Healthcare business and began recording its share of earnings from the Consumer Healthcare JV on a quarterly basis on a one-quarter lag in Other (income)/deductions––net commencing from August 1, 2019. Therefore, Pfizer recorded its share of the JV’s earnings generated in fourth-quarter 2019 in its first-quarter 2020 operating results. |
▪ | On July 30, 2019, Pfizer announced the successful completion of its acquisition of Array BioPharma Inc. (Array). Array’s portfolio included two approved products, Braftovi (encorafenib) and Mektovi (binimetinib). |
▪ | On July 1, 2019, Pfizer announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company, Therachon Holding AG. |
(2) | Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income is defined as net income attributable to Pfizer Inc. in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP. |
(3) | Adjusted income and its components and Adjusted diluted EPS are defined as reported U.S. GAAP net income(2) and its components and reported diluted EPS(2) excluding purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items (some of which may recur, such as gains on the completion of joint venture transactions, restructuring charges, legal charges or gains and losses from equity securities, but which management does not believe are reflective of ongoing core operations). Adjusted cost of sales, Adjusted selling, informational and administrative (SI&A) expenses, Adjusted research and development (R&D) expenses and Adjusted other (income)/deductions are income statement line items prepared on the same basis as, and therefore components of, the overall Adjusted income measure. As described in the Financial Review––Non-GAAP Financial Measure (Adjusted Income) section of Pfizer’s 2019 Financial Report, which was filed as Exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because |
(4) | Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s first quarter for U.S. subsidiaries reflects the three months ending on March 29, 2020 and March 31, 2019 while Pfizer’s first quarter for subsidiaries operating outside the U.S. reflects the three months ending on February 23, 2020 and February 24, 2019. |
(5) | References to operational variances in this press release pertain to period-over-period growth rates that exclude the impact of foreign exchange. The operational variances are determined by multiplying or dividing, as appropriate, the current period U.S. dollar results by the current period average foreign exchange rates and then multiplying or dividing, as appropriate, those amounts by the prior-year period average foreign exchange rates. Although exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control. Exchange rate changes, however, can mask positive or negative trends in the business; therefore, Pfizer believes presenting operational variances provides useful information in evaluating the results of its business. |
(6) | Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of pending litigation, unusual gains and losses, acquisition-related expenses, gains and losses from equity securities and potential future asset impairments without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period. |
▪ | Does not assume the completion of any business development transactions not completed as of March 29, 2020, including any one-time upfront payments associated with such transactions. |
▪ | Includes Pfizer’s pro rata share of the Consumer Healthcare JV(1) anticipated earnings, which is recorded in Adjusted other (income)/deductions(3) on a one-quarter lag. Therefore, 2020 financial guidance for Adjusted other (income)/deductions(3) and Adjusted diluted EPS(3) reflects Pfizer’s share of the JV’s earnings that were generated in fourth-quarter 2019 (recorded by Pfizer in first-quarter 2020) as well as Pfizer’s share of the JV’s projected earnings during the first three quarters of 2020. |
▪ | Reflects an anticipated negative revenue impact of $2.4 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost or are anticipated to soon lose patent protection. |
▪ | Exchange rates assumed are a blend of actual exchange rates in effect through first-quarter 2020 and mid-April 2020 rates for the remainder of the year. Financial guidance reflects the anticipated unfavorable impact of approximately $0.9 billion on revenues and approximately $0.06 on Adjusted diluted EPS(3) as a result of changes in foreign exchange rates relative to the U.S. dollar compared to foreign exchange rates from 2019. |
▪ | Guidance for Adjusted diluted EPS(3) assumes diluted weighted-average shares outstanding of approximately 5.6 billion shares, which assumes no share repurchases in 2020. |
(7) | Financial guidance for Total Company reflects a full-year 2020 contribution from Biopharma and Upjohn, the current construct of the company, and excludes any impact from the pending Upjohn combination with Mylan. |
(8) | Financial guidance for New Pfizer reflects a full-year 2020 pro forma view of the company assuming the pending Upjohn combination with Mylan was completed at the beginning of 2020. Therefore, New Pfizer reflects contributions from the Biopharma business as it is presently being managed, which excludes contributions from Pfizer’s Meridian subsidiary and the Pfizer-Mylan strategic collaboration in Japan (Mylan-Japan). Pfizer’s Meridian subsidiary and Mylan-Japan were managed by Pfizer’s Biopharma business in 2019 but were moved to Upjohn in 2020. Financial guidance for New Pfizer also includes the full-year effect of the following items that assume the completion of the Upjohn combination with Mylan: |
▪ | $12 billion of net proceeds from Upjohn to be retained by Pfizer, which Pfizer will use to repay its own existing indebtedness; and |
▪ | other transaction-related items, such as income from transition services agreements between Pfizer and Viatris. |
(9) | Adjusted income(3) before tax margin (Adjusted IBT margin) is defined as revenue less the sum of Adjusted cost of sales(3), Adjusted SI&A expenses(3), Adjusted R&D expenses(3), Adjusted amortization of intangible assets(3) and Adjusted other (income)/deductions(3) as a percentage of revenue. Adjusted IBT Margin is presented because management believes this performance measure supplements investors’ and other readers’ understanding and assessment of the financial performance of New Pfizer(8). Adjusted IBT margin is not, and should not be viewed as, a substitute for U.S. GAAP income before tax margin. |
(10) | Financial guidance for Upjohn reflects a full-year 2020 contribution from the Upjohn business as it is presently being managed, which includes contributions from Pfizer’s Meridian subsidiary and the Pfizer-Mylan strategic collaboration in Japan (Mylan-Japan). Pfizer’s Meridian subsidiary and Mylan-Japan were managed by Pfizer’s Biopharma business in 2019 but were moved to Upjohn in 2020. |
(11) | Adjusted Earnings Before Interest, Tax, Depreciation and Amortization (EBITDA) is defined as reported U.S. GAAP net income(2), and its components, adjusted for interest expense, provision for taxes on income and depreciation and amortization, further adjusted to exclude purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items (some of which may recur, such as gains on the completion of joint venture transactions, restructuring charges, legal charges or gains and losses from equity securities, but which management does not believe are reflective of ongoing core operations). Adjusted EBITDA is presented because management believes this performance measure supplements investors’ and other readers’ understanding and assessment of the financial performance of Upjohn. Adjusted EBITDA as defined is not a measurement of financial performance under GAAP, and should not be considered as an alternative to net income(2) or cash flow from operations determined in accordance with GAAP. |
(12) | Erbitux® is a registered trademark of ImClone LLC. |
(13) | MabThera® is a registered trademark of Roche, Inc. |
Contacts: | Media | Investors | ||
Amy Rose | 212.733.7410 | Chuck Triano | 212.733.3901 | |
Ryan Crowe | 212.733.8160 | |||
Bryan Dunn | 212.733.8917 | |||
First-Quarter | % Incr. / | |||||||||
2020 | 2019 | (Decr.) | ||||||||
Revenues | $ | 12,028 | $ | 13,118 | (8) | |||||
Costs and expenses: | ||||||||||
Cost of sales (2), (3) | 2,378 | 2,433 | (2) | |||||||
Selling, informational and administrative expenses(2), (3) | 2,873 | 3,339 | (14) | |||||||
Research and development expenses(2), (3) | 1,724 | 1,703 | 1 | |||||||
Amortization of intangible assets(3) | 885 | 1,183 | (25) | |||||||
Restructuring charges and certain acquisition-related costs(4) | 69 | 46 | 49 | |||||||
(Gain) on completion of Consumer Healthcare JV transaction | (6 | ) | — | * | ||||||
Other (income)/deductions––net(5) | 221 | 92 | * | |||||||
Income from continuing operations before provision for taxes on income | 3,885 | 4,323 | (10) | |||||||
Provision for taxes on income(6) | 475 | 433 | 10 | |||||||
Income from continuing operations | 3,410 | 3,889 | (12) | |||||||
Discontinued operations––net of tax | — | — | — | |||||||
Net income before allocation to noncontrolling interests | 3,410 | 3,889 | (12) | |||||||
Less: Net income attributable to noncontrolling interests | 9 | 6 | 62 | |||||||
Net income attributable to Pfizer Inc. | $ | 3,401 | $ | 3,884 | (12) | |||||
Earnings per common share––basic: | ||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.61 | $ | 0.69 | (11) | |||||
Discontinued operations––net of tax | — | — | — | |||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.61 | $ | 0.69 | (11) | |||||
Earnings per common share––diluted: | ||||||||||
Income from continuing operations attributable to Pfizer Inc. common shareholders | $ | 0.61 | $ | 0.68 | (10) | |||||
Discontinued operations––net of tax | — | — | — | |||||||
Net income attributable to Pfizer Inc. common shareholders | $ | 0.61 | $ | 0.68 | (10) | |||||
Weighted-average shares used to calculate earnings per common share: | ||||||||||
Basic | 5,545 | 5,635 | ||||||||
Diluted | 5,613 | 5,750 | ||||||||
* | Indicates calculation not meaningful or result is equal to or greater than 100%. |
(1) | The financial statements present the three months ended March 29, 2020 and March 31, 2019. Subsidiaries operating outside the U.S. are included for the three months ended February 23, 2020 and February 24, 2019. |
(2) | Exclusive of amortization of intangible assets, except as discussed in footnote (3) below. |
(3) | Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets, as these intangible assets benefit multiple business functions. Amortization expense related to intangible assets that are associated with a single function is included in Cost of sales, Selling, informational and administrative expenses and/or Research and development expenses, as appropriate. |
(4) | Restructuring charges and certain acquisition-related costs include the following: |
First-Quarter | ||||||||
(MILLIONS OF DOLLARS) | 2020 | 2019 | ||||||
Restructuring credits––acquisition-related costs(a) | $ | — | $ | (9 | ) | |||
Restructuring charges––cost reduction initiatives(b) | 55 | 19 | ||||||
Restructuring charges | 56 | 10 | ||||||
Transaction costs(c) | 3 | — | ||||||
Integration costs and other(d) | 10 | 36 | ||||||
Restructuring charges and certain acquisition-related costs | $ | 69 | $ | 46 | ||||
(a) | Includes employee termination costs, asset impairments and other exit costs associated with business combinations. Credits in the first quarter of 2019 are due to the reversal of previously recorded accruals. |
(b) | Includes employee termination costs, asset impairments and other exit costs not associated with acquisitions. |
(c) | Transaction costs represent external costs for banking, legal, accounting and other similar services. |
(d) | Integration costs and other represent external, incremental costs directly related to integrating acquired businesses, such as expenditures for consulting and the integration of systems and processes, and certain other qualifying costs. |
(5) | Other (income)/deductions––net includes the following: |
First-Quarter | ||||||||
(MILLIONS OF DOLLARS) | 2020 | 2019 | ||||||
Interest income | $ | (34 | ) | $ | (66 | ) | ||
Interest expense | 390 | 361 | ||||||
Net interest expense | 356 | 295 | ||||||
Royalty-related income | (119 | ) | (89 | ) | ||||
Net (gains)/losses on asset disposals | 1 | (1 | ) | |||||
Net (gains)/losses recognized during the period on equity securities(a) | 255 | (111 | ) | |||||
Income from collaborations, out-licensing arrangements and sales of compound/product rights | (115 | ) | (82 | ) | ||||
Net periodic benefit credits other than service costs | (67 | ) | (40 | ) | ||||
Certain legal matters, net | 10 | 4 | ||||||
Certain asset impairments | — | 150 | ||||||
Business and legal entity alignment costs(b) | — | 119 | ||||||
Net losses on early retirement of debt | — | 138 | ||||||
GSK Consumer Healthcare JV equity method (income)/loss(c) | 33 | — | ||||||
Other, net(d) | (132 | ) | (291 | ) | ||||
Other (income)/deductions––net | $ | 221 | $ | 92 | ||||
(a) | The losses in the first quarter of 2020, include, among other things, unrealized losses of $134 million related to our investment in Allogene Therapeutics, Inc. (Allogene). The gains in the first quarter of 2019 included, among other things, unrealized gains of $43 million related to our investment in Allogene. |
(b) | In the first quarter of 2019, represents incremental costs associated with the design, planning and implementation of our new organizational structure, effective in the beginning of 2019, and primarily includes consulting, legal, tax and advisory services. |
(c) | For additional information, see footnote (1) above. |
(d) | The first quarter of 2020 includes, among other things, dividend income of $77 million from our investment in ViiV Healthcare Limited (ViiV). The first quarter of 2019 included, among other things, credits of $72 million, reflecting the change in the fair value of contingent consideration, and dividend income of $64 million from our investment in ViiV. |
(6) | The increase in the effective tax rate for the first quarter of 2020 compared to the first quarter of 2019 was primarily due to the non-recurrence of the tax benefit recorded in the first quarter of 2019 as a result of additional guidance issued by the U.S. Department of Treasury related to the legislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017 and the decrease in tax benefits associated with the resolution of certain tax positions pertaining to prior years, partially offset by the favorable change in the jurisdictional mix of earnings as a result of operating fluctuations in the normal course of business. |
First-Quarter 2020 | ||||||||||||||||||||||||
GAAP Reported | Purchase Accounting Adjustments | Acquisition-Related Items(2) | Discontinued Operations | Certain Significant Items(3) | Non-GAAP Adjusted(4) | |||||||||||||||||||
Revenues | $ | 12,028 | $ | — | $ | — | $ | — | $ | — | $ | 12,028 | ||||||||||||
Cost of sales(5), (6) | 2,378 | 4 | — | — | (32 | ) | 2,350 | |||||||||||||||||
Selling, informational and administrative expenses(5), (6) | 2,873 | — | — | — | (129 | ) | 2,745 | |||||||||||||||||
Research and development expenses (5), (6) | 1,724 | 1 | — | — | 2 | 1,727 | ||||||||||||||||||
Amortization of intangible assets(6) | 885 | (814 | ) | — | — | — | 71 | |||||||||||||||||
Restructuring charges and certain acquisition-related costs | 69 | — | (13 | ) | — | (55 | ) | — | ||||||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | (6 | ) | — | — | — | 6 | — | |||||||||||||||||
Other (income)/deductions––net(7) | 221 | (3 | ) | — | — | (403 | ) | (186 | ) | |||||||||||||||
Income from continuing operations before provision for taxes on income | 3,885 | 812 | 13 | — | 612 | 5,322 | ||||||||||||||||||
Provision for taxes on income | 475 | 180 | 3 | — | 140 | 799 | ||||||||||||||||||
Income from continuing operations | 3,410 | 632 | 10 | — | 472 | 4,523 | ||||||||||||||||||
Discontinued operations––net of tax | — | — | — | — | — | — | ||||||||||||||||||
Net income attributable to noncontrolling interests | 9 | — | — | — | — | 9 | ||||||||||||||||||
Net income attributable to Pfizer Inc. | 3,401 | 632 | 10 | — | 472 | 4,514 | ||||||||||||||||||
Earnings per common share attributable to Pfizer Inc.––diluted | 0.61 | 0.11 | — | — | 0.08 | 0.80 | ||||||||||||||||||
First-Quarter 2019 | ||||||||||||||||||||||||
GAAP Reported | Purchase Accounting Adjustments | Acquisition-Related Items(2) | Discontinued Operations | Certain Significant Items(3) | Non-GAAP Adjusted(4) | |||||||||||||||||||
Revenues | $ | 13,118 | $ | — | $ | — | $ | — | $ | — | $ | 13,118 | ||||||||||||
Cost of sales(5), (6) | 2,433 | 4 | — | — | (22 | ) | 2,415 | |||||||||||||||||
Selling, informational and administrative expenses(5), (6) | 3,339 | 1 | (1 | ) | — | (27 | ) | 3,311 | ||||||||||||||||
Research and development expenses(5), (6) | 1,703 | 1 | — | — | (11 | ) | 1,693 | |||||||||||||||||
Amortization of intangible assets(6) | 1,183 | (1,120 | ) | — | — | — | 63 | |||||||||||||||||
Restructuring charges and certain acquisition-related costs | 46 | — | (27 | ) | — | (19 | ) | — | ||||||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | — | — | — | — | — | — | ||||||||||||||||||
Other (income)/deductions––net(7) | 92 | 76 | — | — | (303 | ) | (135 | ) | ||||||||||||||||
Income from continuing operations before provision for taxes on income | 4,323 | 1,038 | 28 | — | 382 | 5,771 | ||||||||||||||||||
Provision for taxes on income | 433 | 224 | 5 | — | 212 | 875 | ||||||||||||||||||
Income from continuing operations | 3,889 | 814 | 23 | — | 171 | 4,896 | ||||||||||||||||||
Discontinued operations––net of tax | — | — | — | — | — | — | ||||||||||||||||||
Net income attributable to noncontrolling interests | 6 | — | — | — | — | 6 | ||||||||||||||||||
Net income attributable to Pfizer Inc. | 3,884 | 814 | 23 | — | 171 | 4,891 | ||||||||||||||||||
Earnings per common share attributable to Pfizer Inc.––diluted | 0.68 | 0.14 | — | — | 0.03 | 0.85 | ||||||||||||||||||
(1) | The Array BioPharma Inc. and Therachon Holding AG acquisitions and the contribution of our Consumer Healthcare business to the GSK Consumer Healthcare joint venture that were completed in 2019 impacted our results of operations in the periods presented. Our financial results, and our Consumer Healthcare segment’s operating results, for the first quarter of 2019 reflect three months of Consumer Healthcare segment operations while financial results for the first quarter of 2020 do not reflect any contribution from the Consumer Healthcare business. We record our share of earnings from the GSK Consumer Healthcare joint venture on a quarterly basis on a one-quarter lag in Other (income)/deductions––net commencing from August 1, 2019. Therefore, we recorded our share of the joint venture’s earnings/losses generated in the fourth quarter of 2019 in our operating results in the first quarter of 2020. For the non-GAAP measure of Adjusted Earnings (see footnote (4) below), charges primarily related to our pro rata share of restructuring and business combination accounting charges recorded by the Consumer Healthcare joint venture have been excluded from the measure. |
(2) | Acquisition-related items include the following: |
First-Quarter | ||||||||
(MILLIONS OF DOLLARS) | 2020 | 2019 | ||||||
Restructuring credits(a) | $ | — | $ | (9 | ) | |||
Transaction costs(b) | 3 | — | ||||||
Integration costs and other(c) | 10 | 36 | ||||||
Additional depreciation––asset restructuring(d) | — | 1 | ||||||
Total acquisition-related items––pre-tax | 13 | 28 | ||||||
Income taxes(e) | (3 | ) | (5 | ) | ||||
Total acquisition-related items––net of tax | $ | 10 | $ | 23 | ||||
(a) | Includes employee termination costs, asset impairments and other exit costs associated with business combinations. Credits in the first quarter of 2019 are due to the reversal of previously recorded accruals. All of these items are included in Restructuring charges and certain acquisition-related costs. |
(b) | Transaction costs represent external costs for banking, legal, accounting and other similar services. All of these items are included in Restructuring charges and certain acquisition-related costs. |
(c) | Integration costs and other represent external, incremental costs directly related to integrating acquired businesses, such as expenditures for consulting and the integration of systems and processes, and certain other qualifying costs. All of these costs and charges are included in Restructuring charges and certain acquisition-related costs. |
(d) | Represents the impact of changes in the estimated useful lives of assets involved in restructuring actions related to acquisitions. In the first quarter of 2019, included in Selling, informational and administrative expenses. |
(e) | Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. |
(3) | Certain significant items include the following: |
First-Quarter | ||||||||
(MILLIONS OF DOLLARS) | 2020 | 2019 | ||||||
Restructuring charges––cost reduction initiatives(a) | $ | 55 | $ | 19 | ||||
Implementation costs and additional depreciation––asset restructuring(b) | 25 | 38 | ||||||
Net (gains)/losses recognized during the period on equity securities(c) | 195 | (111 | ) | |||||
Certain legal matters, net(c) | 10 | (6 | ) | |||||
Certain asset impairments(c) | — | 139 | ||||||
Business and legal entity alignment costs(d) | 115 | 119 | ||||||
Net losses on early retirement of debt(c) | — | 138 | ||||||
Other(e) | 212 | 46 | ||||||
Total certain significant items––pre-tax | 612 | 382 | ||||||
Income taxes(f) | 140 | 212 | ||||||
Total certain significant items––net of tax | $ | 472 | $ | 171 | ||||
(a) | Includes employee termination costs, asset impairments and other exit costs not associated with acquisitions, which are included in Restructuring charges and certain acquisition-related costs. |
(b) | Relates to our cost-reduction and productivity initiatives not related to acquisitions. Primarily included in Cost of sales ($15 million) and Selling, informational and administrative expenses ($15 million) for the first quarter of 2020. Primarily included in Cost of sales ($22 million) for the first quarter of 2019. |
(c) | Included in Other (income)/deductions––net. |
(d) | In the first quarter of 2020, primarily included in Cost of sales ($15 million) and Selling, informational and administrative expenses ($98 million) and represents separation costs associated with our planned Upjohn transaction with Mylan, and mainly includes consulting, legal, tax and advisory services. In the first quarter of 2019, included in Other (income)/deductions––net and represents incremental costs associated with the design, planning and implementation of our new organizational structure, effective in the beginning of 2019, and primarily includes consulting, legal, tax and advisory services. |
(e) | For the first quarter of 2020, primarily included in Selling, informational and administrative expenses ($17 million) and Other (income)/deductions––net ($199 million). For the first quarter of 2019, primarily included in Selling, informational and administrative expenses ($18 million) and Other (income)/deductions––net ($24 million). The first quarter of 2020 includes, among other things, charges of $160 million recorded in Other (income)/deductions––net primarily representing our pro rata share of restructuring and business combination accounting charges recorded by the GSK Consumer Healthcare joint venture. See footnote (1) above. |
(f) | Included in Provision for taxes on income. Income taxes includes the tax effect of the associated pre-tax amounts, calculated by determining the jurisdictional location of the pre-tax amounts and applying that jurisdiction’s applicable tax rate. The first quarter of 2019 was favorably impacted primarily by the tax benefit recorded as a result of additional guidance issued by the U.S. Department of Treasury related to the legislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017. |
(4) | Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS. Despite the importance of these measures to management in goal setting and performance measurement (as described in the Financial Review––Non-GAAP Financial Measure (Adjusted Income) section of Pfizer’s 2019 Financial Report, which was filed as Exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019), Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are non-GAAP financial measures that have no standardized meaning prescribed by U.S. GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS (unlike U.S. GAAP net income and its components and diluted EPS) may not be comparable to the calculation of similar measures of other companies. Non-GAAP Adjusted income and its components and Non-GAAP Adjusted diluted EPS are presented solely to permit investors to more fully understand how management assesses performance. |
(5) | Exclusive of amortization of intangible assets, except as discussed in footnote (6) below. |
(6) | Amortization expense related to finite-lived acquired intangible assets that contribute to our ability to sell, manufacture, research, market and distribute products, compounds and intellectual property is included in Amortization of intangible assets as these intangible assets benefit multiple business functions. Amortization expense |
(7) | Non-GAAP Adjusted Other (income)/deductions––net includes the following: |
First-Quarter | ||||||||
(MILLIONS OF DOLLARS) | 2020 | 2019 | ||||||
Interest income | $ | (34 | ) | $ | (66 | ) | ||
Interest expense | 395 | 366 | ||||||
Net interest expense | 361 | 300 | ||||||
Royalty-related income | (119 | ) | (89 | ) | ||||
Net (gains)/losses on asset disposals | 1 | (1 | ) | |||||
Net losses recognized during the period on equity securities | 60 | — | ||||||
Income from collaborations, out-licensing arrangements and sales of compound/product rights | (115 | ) | (82 | ) | ||||
Net periodic benefit credits other than service costs | (102 | ) | (46 | ) | ||||
Certain legal matters, net | — | 10 | ||||||
Certain asset impairments | — | 11 | ||||||
GSK Consumer Healthcare JV equity method (income)/loss | (127 | ) | — | |||||
Other, net | (145 | ) | (238 | ) | ||||
Non-GAAP Adjusted Other (income)/deductions––net | $ | (186 | ) | $ | (135 | ) | ||
The following tables provide revenue and cost information by reportable operating segment and a reconciliation of that information to our consolidated statements of income: | ||||||||||||||||||||||||
First-Quarter 2020 | ||||||||||||||||||||||||
Biopharma(2) | Upjohn(2) | Other(3) | Non-GAAP Adjusted(4) | Reconciling Items(5) | GAAP Reported | |||||||||||||||||||
Revenues | $ | 10,007 | $ | 2,022 | $ | — | $ | 12,028 | $ | — | $ | 12,028 | ||||||||||||
Cost of sales | 1,775 | 497 | 78 | 2,350 | 28 | 2,378 | ||||||||||||||||||
% of revenue | 17.7 | % | 24.6 | % | * | 19.5 | % | * | 19.8 | % | ||||||||||||||
Selling, informational and administrative expenses | 1,492 | 286 | 967 | 2,745 | 128 | 2,873 | ||||||||||||||||||
Research and development expenses | 185 | 55 | 1,487 | 1,727 | (3 | ) | 1,724 | |||||||||||||||||
Amortization of intangible assets | 71 | — | — | 71 | 814 | 885 | ||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | 69 | 69 | ||||||||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | — | — | — | — | (6 | ) | (6 | ) | ||||||||||||||||
Other (income)/deductions––net | (245 | ) | (7 | ) | 66 | (186 | ) | 407 | 221 | |||||||||||||||
Income/(loss) from continuing operations before provision for taxes on income | 6,729 | 1,191 | (2,598 | ) | 5,322 | (1,437 | ) | 3,885 | ||||||||||||||||
First-Quarter 2019 | ||||||||||||||||||||||||
Biopharma(2) | Upjohn(2) | Other(3) | Non-GAAP Adjusted(4) | Reconciling Items(5) | GAAP Reported | |||||||||||||||||||
Revenues | $ | 9,045 | $ | 3,214 | $ | 858 | $ | 13,118 | $ | — | $ | 13,118 | ||||||||||||
Cost of sales | 1,642 | 537 | 236 | 2,415 | 18 | 2,433 | ||||||||||||||||||
% of revenue | 18.2 | % | 16.7 | % | * | 18.4 | % | * | 18.5 | % | ||||||||||||||
Selling, informational and administrative expenses | 1,516 | 336 | 1,459 | 3,311 | 27 | 3,339 | ||||||||||||||||||
Research and development expenses | 164 | 55 | 1,474 | 1,693 | 10 | 1,703 | ||||||||||||||||||
Amortization of intangible assets | 63 | — | — | 63 | 1,120 | 1,183 | ||||||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | 46 | 46 | ||||||||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | — | — | — | — | — | — | ||||||||||||||||||
Other (income)/deductions––net | (222 | ) | 7 | 80 | (135 | ) | 227 | 92 | ||||||||||||||||
Income/(loss) from continuing operations before provision for taxes on income | 5,883 | 2,279 | (2,391 | ) | 5,771 | (1,449 | ) | 4,323 | ||||||||||||||||
(1) | At the beginning of our 2019 fiscal year, we reorganized our commercial operations and began to manage our commercial operations through a new global structure consisting of three distinct business segments: Pfizer Biopharmaceuticals Group (Biopharma), Upjohn and through July 31, 2019, Pfizer’s Consumer Healthcare business (Consumer Healthcare). See footnote (2) below for additional information. |
(2) | Amounts represent the revenues and costs managed by each of the Biopharma and Upjohn reportable operating segments for the periods presented. The expenses generally include only those costs directly attributable to the operating segment. The segment information presents the three months ended March 29, 2020 and March 31, 2019. Subsidiaries operating outside the U.S. are included for the three months ended February 23, 2020 and February 24, 2019. |
Some additional information about our Biopharma and Upjohn business segments follows: | |||
![]() | Pfizer Biopharmaceuticals Group | ![]() | |
Biopharma is a science-based medicines business that includes six business units – Oncology, Inflammation & Immunology, Rare Disease, Hospital, Vaccines and Internal Medicine. The Hospital unit commercializes our global portfolio of sterile injectable and anti-infective medicines and includes Pfizer’s contract manufacturing operation, Pfizer CentreOne. Each business unit is committed to delivering breakthroughs that change patients’ lives. | Upjohn is a global, primarily off-patent branded and generic medicines business, which includes a portfolio of 20 globally recognized solid oral dose brands, as well as a U.S.-based generics platform, Greenstone. | ||
Select products include: - Prevnar 13/Prevenar 13 - Eliquis - Ibrance - Xeljanz - Enbrel (outside the U.S. and Canada) - Chantix/Champix - Vyndaqel/Vyndamax - Xtandi - Sutent | Select products include: - Lipitor - Lyrica - Norvasc - Celebrex - Viagra - Certain generic medicines | ||
• | Cost of sales as a percentage of Revenues was relatively flat. |
• | The increase in Cost of sales of 8% was mainly driven by an increase in sales volumes for various products within our product portfolio, an unfavorable change in product mix, and an increase in royalty expenses based on the mix of products sold. |
• | The decrease in Selling, informational and administrative expenses of 2% was mostly driven by lower investments across the Inflammation & Immunology portfolio, lower healthcare reform expenses, and a favorable impact of foreign exchange, partially offset by additional investment in emerging markets, the Oncology portfolio in developed markets, and for marketing and promotional expenses associated with the U.S. launches of Vyndaqel in May 2019 and Vyndamax in September 2019. |
• | The increase in Research and development expenses of 13% was mainly related to increased medical spending, primarily for Oncology, Internal Medicine and Rare Disease. |
• | The favorable change in Other (income)/deductions––net includes, among other things, an increase in royalty-related income, an increase in income from collaborations, out-licensing arrangements and sales of compound/product rights, and an increase in dividend income from our investment in ViiV Healthcare Limited. |
• | Cost of sales as a percentage of Revenues increased 7.9 percentage points, driven by lower Lyrica revenues, primarily in the U.S. due to multi-source generic competition that began in July 2019, lower Lipitor and Norvasc revenues due to the Volume-Based Procurement (VBP) program in China, which was initially implemented in March 2019 and expanded nationwide beginning in December 2019, and an unfavorable impact of foreign exchange, partially offset by lower royalty expense for Lyrica due to the patent expiration. |
• | The decrease in Cost of sales of 7% was mainly driven by lower royalty expense and a decrease in sales volume due to the Lyrica patent expiration and multi-source generic competition that began in July 2019, as well as decreases in sales volumes of Lipitor and Norvasc due to the VBP program in China, which was initially implemented in March 2019 and expanded nationwide beginning in December 2019, partially offset by an unfavorable impact of foreign exchange. |
• | Selling, informational and administrative expenses decreased 15% driven by a reduction in field force expense as well as advertising and promotion expenses, primarily related to Lyrica in the U.S. due to the patent expiration, as well as a decrease in Lipitor and Norvasc expenses due to the VBP program in China, which was initially implemented in March 2019 and expanded nationwide beginning in December 2019, partially offset by expenses for enabling functions that provide autonomy and position Upjohn to operate as a stand-alone division. |
• | Research and development expenses and Other (income)/deductions––net were relatively unchanged. |
(3) | Other comprises the revenues and costs included in our Adjusted income components (see footnote (c) below) that are managed outside Biopharma and Upjohn and includes the following: |
First-Quarter 2020 | ||||||||||||||||||||
Other Business Activities | ||||||||||||||||||||
(IN MILLIONS) | WRDM(a) | GPD(b) | Other(c) | Corporate and Other Unallocated(d) | Total | |||||||||||||||
Revenues | $ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
Cost of sales | (1 | ) | — | — | 79 | 78 | ||||||||||||||
Selling, informational and administrative expenses | 29 | — | 106 | 832 | 967 | |||||||||||||||
Research and development expenses | 578 | 771 | 6 | 132 | 1,487 | |||||||||||||||
Amortization of intangible assets | — | — | — | — | — | |||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | |||||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | — | — | — | — | — | |||||||||||||||
Other (income)/deductions––net | 3 | (4 | ) | 1 | 66 | 66 | ||||||||||||||
Income/(loss) from continuing operations before provision for taxes on income | (609 | ) | (767 | ) | (113 | ) | (1,110 | ) | (2,598 | ) | ||||||||||
First-Quarter 2019 | ||||||||||||||||||||
Other Business Activities | ||||||||||||||||||||
(IN MILLIONS) | WRDM(a) | GPD(b) | Other(c) | Corporate and Other Unallocated(d) | Total | |||||||||||||||
Revenues | $ | — | $ | — | $ | 858 | $ | — | $ | 858 | ||||||||||
Cost of sales | — | — | 275 | (38 | ) | 236 | ||||||||||||||
Selling, informational and administrative expenses | 21 | — | 388 | 1,050 | 1,459 | |||||||||||||||
Research and development expenses | 532 | 726 | 30 | 185 | 1,474 | |||||||||||||||
Amortization of intangible assets | — | — | — | — | — | |||||||||||||||
Restructuring charges and certain acquisition-related costs | — | — | — | — | — | |||||||||||||||
(Gain) on completion of Consumer Healthcare JV transaction | — | — | — | — | — | |||||||||||||||
Other (income)/deductions––net | (1 | ) | (1 | ) | 1 | 80 | 80 | |||||||||||||
Income/(loss) from continuing operations before provision for taxes on income | (552 | ) | (726 | ) | 164 | (1,278 | ) | (2,391 | ) | |||||||||||
(a) | WRDM––the R&D and Medical expenses managed by our Worldwide Research, Development and Medical (WRDM) organization, which is generally responsible for research projects for our Biopharma portfolio until proof-of-concept is achieved and then for transitioning those projects to the GPD organization for possible clinical and commercial development. R&D spending may include upfront and milestone payments for intellectual property rights. The WRDM organization also has responsibility for certain science-based and other platform-services organizations, which provide end-to-end technical expertise and other services to the various R&D projects, as well as the Worldwide Medical and Safety group, which ensures that Pfizer provides all stakeholders––including patients, healthcare providers, pharmacists, payers and health authorities––with complete and up-to-date information on the risks and benefits associated with Pfizer products so that they can make appropriate decisions on how and when to use Pfizer’s medicines. |
(b) | GPD––the costs associated with our GPD organization, which is generally responsible for clinical trials from WRDM in the Biopharma portfolio, including late stage portfolio spend. GPD also provides technical support and other services to Pfizer R&D projects. GPD is responsible for facilitating all regulatory submissions and interactions with regulatory agencies. |
(c) | Other––the operating results of our Consumer Healthcare business, through July 31, 2019, and costs associated with other commercial activities not managed as part of Biopharma or Upjohn, including all strategy, business development, portfolio management and valuation capabilities, which previously had been reported in various parts of the organization. See Note (1) above. |
(d) | Corporate and Other Unallocated––the costs associated with platform functions (such as worldwide technology, global real estate operations, legal, finance, human resources, worldwide public affairs, compliance and worldwide procurement), patient advocacy activities and certain compensation and other corporate costs, such as interest income and expense, and gains and losses on investments, as well as overhead expenses associated with our manufacturing (which include manufacturing variances associated with production) and commercial operations that are not directly assessed to an operating segment, as business unit (segment) management does not manage these costs. |
(4) | These “Adjusted Income” components are defined as the corresponding reported U.S. GAAP components, excluding purchase accounting adjustments, acquisition-related costs and certain significant items (some of which may recur, such as gains on the completion of joint venture transactions, restructuring charges, legal charges or gains and losses from equity securities, but which management does not believe are reflective of our ongoing core operations). Adjusted Cost of Sales, Adjusted Selling, Informational and Administrative (SI&A) expenses, Adjusted Research and Development (R&D) expenses, Adjusted Amortization of Intangible Assets and Adjusted Other (Income)/Deductions––Net are income statement line items prepared on the same basis as, and therefore components of, the overall adjusted income measure. As described in the Financial Review––Non-GAAP Financial Measure (Adjusted Income) section of Pfizer’s 2019 Financial Report, which was filed as Exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, management uses Adjusted income, among other factors, to set performance goals and to measure the performance of the overall company. Because Adjusted income is an important internal measurement for Pfizer, we believe that investors’ understanding of our performance is enhanced by disclosing this performance measure. We report Adjusted income and certain components of Adjusted income in order to portray the results of our major operations––the discovery, development, manufacture, marketing and sale of |
(5) | Includes costs associated with (i) purchase accounting adjustments; (ii) acquisition-related costs; and (iii) certain significant items, which are substantive and/or unusual, and in some cases recurring, items (such as gains on the completion of joint venture transactions, restructuring charges, legal charges or gains and losses from equity securities) that are evaluated on an individual basis by management. For additional information about these reconciling items and/or our non-GAAP adjusted measure of performance, see the accompanying reconciliations of certain GAAP reported to non-GAAP adjusted information for the first quarter of 2020 and 2019. |
WORLDWIDE | UNITED STATES | TOTAL INTERNATIONAL(a) | ||||||||||||||||||||||
2020 | 2019 | % Change | 2020 | 2019 | % Change | 2020 | 2019 | % Change | ||||||||||||||||
(MILLIONS OF DOLLARS) | Total | Oper. | Total | Total | Oper. | |||||||||||||||||||
TOTAL REVENUES | $ | 12,028 | $ | 13,118 | (8%) | (7%) | $ | 5,651 | $ | 6,175 | (8%) | $ | 6,377 | $ | 6,943 | (8%) | (6%) | |||||||
PFIZER BIOPHARMACEUTICALS GROUP (BIOPHARMA) | $ | 10,007 | $ | 9,045 | 11% | 12% | $ | 5,213 | $ | 4,461 | 17% | $ | 4,793 | $ | 4,584 | 5% | 7% | |||||||
Internal Medicine(b) | $ | 2,332 | $ | 2,137 | 9% | 10% | $ | 1,348 | $ | 1,181 | 14% | $ | 984 | $ | 956 | 3% | 5% | |||||||
Eliquis alliance revenues and direct sales | 1,300 | 1,011 | 29% | 29% | 805 | 601 | 34% | 495 | 410 | 21% | 23% | |||||||||||||
Chantix/Champix | 270 | 273 | (1%) | — | 212 | 212 | — | 59 | 61 | (3%) | (1%) | |||||||||||||
Premarin family | 152 | 168 | (10%) | (10%) | 141 | 158 | (10%) | 10 | 10 | 1% | 1% | |||||||||||||
BMP2 | 69 | 67 | 4% | 4% | 69 | 67 | 4% | — | — | — | — | |||||||||||||
Toviaz | 60 | 60 | — | — | 19 | 17 | 13% | 41 | 43 | (5%) | (5%) | |||||||||||||
All other Internal Medicine | 480 | 559 | (14%) | (12%) | 102 | 127 | (20%) | 378 | 432 | (12%) | (10%) | |||||||||||||
Oncology | $ | 2,435 | $ | 1,961 | 24% | 25% | $ | 1,572 | $ | 1,179 | 33% | $ | 863 | $ | 782 | 10% | 14% | |||||||
Ibrance | 1,248 | 1,133 | 10% | 11% | 852 | 741 | 15% | 396 | 392 | 1% | 5% | |||||||||||||
Xtandi alliance revenues | 209 | 168 | 25% | 25% | 209 | 168 | 25% | — | — | — | — | |||||||||||||
Sutent | 205 | 232 | (12%) | (9%) | 52 | 71 | (27%) | 153 | 161 | (5%) | (2%) | |||||||||||||
Inlyta | 169 | 73 | * | * | 116 | 33 | * | 53 | 40 | 32% | 36% | |||||||||||||
Xalkori | 149 | 123 | 22% | 24% | 39 | 34 | 14% | 110 | 88 | 24% | 27% | |||||||||||||
Bosulif | 100 | 80 | 24% | 24% | 68 | 54 | 26% | 32 | 27 | 21% | 21% | |||||||||||||
Retacrit(c) | 89 | 31 | * | * | 66 | 14 | * | 23 | 17 | 37% | 42% | |||||||||||||
Braftovi | 37 | — | * | * | 37 | — | * | — | — | — | — | |||||||||||||
Mektovi | 37 | — | * | * | 37 | — | * | — | — | — | — | |||||||||||||
All other Oncology | 192 | 122 | 57% | 58% | 96 | 65 | 49% | 95 | 57 | 66% | 69% | |||||||||||||
Hospital(b), (d) | $ | 2,012 | $ | 1,827 | 10% | 11% | $ | 814 | $ | 692 | 18% | $ | 1,198 | $ | 1,135 | 6% | 7% | |||||||
Sulperazon | 187 | 177 | 6% | 8% | — | — | — | 187 | 177 | 6% | 8% | |||||||||||||
Zithromax | 138 | 104 | 32% | 34% | 3 | (3 | ) | * | 136 | 107 | 26% | 28% | ||||||||||||
Medrol | 129 | 120 | 8% | 8% | 78 | 70 | 10% | 51 | 50 | 4% | 4% | |||||||||||||
Vfend | 74 | 85 | (12%) | (11%) | 1 | 4 | (68%) | 73 | 81 | (9%) | (8%) | |||||||||||||
Panzyga | 74 | 17 | * | * | 74 | 17 | * | — | — | — | — | |||||||||||||
Zyvox | 70 | 64 | 11% | 12% | 6 | 5 | 20% | 64 | 58 | 10% | 12% | |||||||||||||
Fragmin | 59 | 60 | (1%) | — | 2 | 2 | 6% | 57 | 58 | (1%) | — | |||||||||||||
Pfizer CentreOne(e) | 152 | 176 | (13%) | (13%) | 76 | 97 | (21%) | 76 | 79 | (4%) | (2%) | |||||||||||||
All other Anti-infectives | 444 | 405 | 10% | 11% | 136 | 128 | 6% | 308 | 277 | 11% | 13% | |||||||||||||
All other Hospital(d) | 684 | 620 | 10% | 11% | 438 | 371 | 18% | 246 | 249 | (1%) | — | |||||||||||||
Vaccines | $ | 1,611 | $ | 1,612 | — | 1% | $ | 812 | $ | 894 | (9%) | $ | 799 | $ | 718 | 11% | 14% | |||||||
Prevnar 13/Prevenar 13 | 1,450 | 1,486 | (2%) | (1%) | 794 | 878 | (10%) | 656 | 608 | 8% | 11% | |||||||||||||
Nimenrix | 75 | 50 | 50% | 54% | — | — | — | 75 | 50 | 50% | 54% | |||||||||||||
All other Vaccines | 86 | 77 | 13% | 15% | 18 | 17 | 7% | 69 | 60 | 14% | 17% | |||||||||||||
Inflammation & Immunology (I&I) | $ | 978 | $ | 1,037 | (6%) | (4%) | $ | 391 | $ | 378 | 3% | $ | 587 | $ | 659 | (11%) | (8%) | |||||||
Xeljanz | 451 | 423 | 7% | 8% | 286 | 298 | (4%) | 166 | 125 | 33% | 38% | |||||||||||||
Enbrel (Outside the U.S. and Canada) | 347 | 451 | (23%) | (21%) | — | — | — | 347 | 451 | (23%) | (21%) | |||||||||||||
Inflectra/Remsima(c) | 158 | 138 | 14% | 15% | 84 | 57 | 46% | 74 | 81 | (8%) | (6%) | |||||||||||||
All other I&I | 22 | 25 | (12%) | (13%) | 21 | 22 | (4%) | 1 | 3 | (70%) | (82%) | |||||||||||||
Rare Disease | $ | 639 | $ | 470 | 36% | 38% | $ | 277 | $ | 137 | * | $ | 362 | $ | 333 | 9% | 12% | |||||||
Vyndaqel/Vyndamax | 231 | 41 | * | * | 127 | — | * | 105 | 41 | * | * | |||||||||||||
BeneFIX | 121 | 125 | (3%) | (2%) | 66 | 65 | 1% | 55 | 60 | (8%) | (4%) | |||||||||||||
Genotropin | 103 | 107 | (4%) | (3%) | 31 | 13 | * | 72 | 95 | (24%) | (22%) | |||||||||||||
Refacto AF/Xyntha | 89 | 106 | (16%) | (14%) | 19 | 27 | (31%) | 71 | 79 | (10%) | (8%) | |||||||||||||
Somavert | 64 | 59 | 7% | 9% | 25 | 22 | 17% | 38 | 38 | 1% | 4% | |||||||||||||
All other Rare Disease | 31 | 31 | — | 5% | 9 | 10 | (6%) | 21 | 20 | 4% | 11% | |||||||||||||
UPJOHN(b) | $ | 2,022 | $ | 3,214 | (37%) | (37%) | $ | 438 | $ | 1,273 | (66%) | $ | 1,584 | $ | 1,941 | (18%) | (17%) | |||||||
Lipitor | 405 | 622 | (35%) | (34%) | 25 | 21 | 17% | 380 | 601 | (37%) | (35%) | |||||||||||||
Lyrica | 357 | 1,186 | (70%) | (70%) | 80 | 889 | (91%) | 277 | 298 | (7%) | (7%) | |||||||||||||
Norvasc | 197 | 300 | (34%) | (33%) | 9 | 10 | (13%) | 188 | 289 | (35%) | (34%) | |||||||||||||
Celebrex | 156 | 174 | (10%) | (10%) | 11 | 15 | (23%) | 145 | 159 | (9%) | (9%) | |||||||||||||
Viagra | 127 | 145 | (12%) | (12%) | 17 | 40 | (57%) | 110 | 105 | 5% | 5% | |||||||||||||
Zoloft | 78 | 69 | 13% | 15% | 12 | 11 | 7% | 66 | 58 | 14% | 17% | |||||||||||||
Effexor | 77 | 77 | (1%) | — | 16 | 17 | (6%) | 61 | 60 | 1% | 2% | |||||||||||||
EpiPen(b) | 72 | 56 | 28% | 28% | 72 | 56 | 28% | — | — | — | — | |||||||||||||
Xalatan/Xalacom | 61 | 62 | (2%) | (1%) | 3 | 5 | (43%) | 58 | 56 | 2% | 3% | |||||||||||||
All other Upjohn | 492 | 523 | (6%) | (5%) | 192 | 209 | (8%) | 300 | 313 | (4%) | (4%) | |||||||||||||
CONSUMER HEALTHCARE BUSINESS(f) | $ | — | $ | 858 | (100%) | (100%) | $ | — | $ | 440 | (100%) | $ | — | $ | 418 | (100%) | (100%) | |||||||
Total Alliance revenues | $ | 1,382 | $ | 1,090 | 27% | 27% | $ | 1,022 | $ | 775 | 32% | $ | 360 | $ | 314 | 15% | 16% | |||||||
Total Biosimilars(c) | $ | 288 | $ | 179 | 61% | 63% | $ | 167 | $ | 73 | * | $ | 122 | $ | 106 | 15% | 17% | |||||||
Total Sterile Injectable Pharmaceuticals(g) | $ | 1,407 | $ | 1,237 | 14% | 15% | $ | 721 | $ | 591 | 22% | $ | 686 | $ | 645 | 6% | 8% | |||||||
DEVELOPED EUROPE(h) | DEVELOPED REST OF WORLD(i) | EMERGING MARKETS(j) | |||||||||||||||||||||||
2020 | 2019 | % Change | 2020 | 2019 | % Change | 2020 | 2019 | % Change | |||||||||||||||||
(MILLIONS OF DOLLARS) | Total | Oper. | Total | Oper. | Total | Oper. | |||||||||||||||||||
TOTAL INTERNATIONAL REVENUES | $ | 1,921 | $ | 2,086 | (8%) | (6%) | $ | 1,456 | $ | 1,535 | (5%) | (5%) | $ | 3,001 | $ | 3,322 | (10%) | (7%) | |||||||
PFIZER BIOPHARMACEUTICALS GROUP (BIOPHARMA) | $ | 1,708 | $ | 1,762 | (3%) | (1%) | $ | 919 | $ | 878 | 5% | 5% | $ | 2,166 | $ | 1,944 | 11% | 15% | |||||||
Internal Medicine(b) | $ | 455 | $ | 428 | 6% | 9% | $ | 212 | $ | 212 | — | — | $ | 317 | $ | 316 | — | 4% | |||||||
Eliquis alliance revenues and direct sales | 278 | 239 | 16% | 19% | 87 | 79 | 10% | 10% | 130 | 92 | 42% | 44% | |||||||||||||
Chantix/Champix | 34 | 20 | 68% | 72% | 15 | 17 | (13%) | (11%) | 10 | 24 | (57%) | (56%) | |||||||||||||
Premarin family | — | — | — | — | 5 | 5 | 1% | 1% | 5 | 5 | 1% | 2% | |||||||||||||
BMP2 | — | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||
Toviaz | 16 | 17 | (6%) | (4%) | 22 | 24 | (7%) | (8%) | 3 | 3 | 12% | 17% | |||||||||||||
All other Internal Medicine | 127 | 152 | (16%) | (14%) | 83 | 87 | (5%) | (5%) | 168 | 193 | (13%) | (8%) | |||||||||||||
Oncology | $ | 365 | $ | 393 | (7%) | (5%) | $ | 167 | $ | 153 | 9% | 9% | $ | 332 | $ | 236 | 41% | 48% | |||||||
Ibrance | 197 | 228 | (13%) | (11%) | 85 | 74 | 15% | 14% | 114 | 90 | 27% | 37% | |||||||||||||
Xtandi alliance revenues | — | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||
Sutent | 61 | 76 | (19%) | (17%) | 21 | 26 | (18%) | (18%) | 71 | 59 | 19% | 25% | |||||||||||||
Inlyta | 14 | 9 | 63% | 67% | 16 | 17 | (6%) | (7%) | 23 | 15 | 58% | 65% | |||||||||||||
Xalkori | 23 | 29 | (22%) | (20%) | 11 | 13 | (17%) | (16%) | 76 | 46 | 65% | 69% | |||||||||||||
Bosulif | 15 | 15 | 3% | 5% | 11 | 10 | 13% | 11% | 6 | 2 | * | * | |||||||||||||
Retacrit(c) | 22 | 16 | 36% | 40% | — | — | — | — | — | — | — | — | |||||||||||||
Braftovi | — | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||
Mektovi | — | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||
All other Oncology | 31 | 20 | 54% | 57% | 23 | 13 | 70% | 69% | 42 | 24 | 75% | 78% | |||||||||||||
Hospital(b), (d) | $ | 207 | $ | 219 | (5%) | (3%) | $ | 168 | $ | 184 | (9%) | (8%) | $ | 822 | $ | 732 | 12% | 14% | |||||||
Sulperazon | — | — | — | — | 2 | 2 | 1% | (1%) | 185 | 175 | 6% | 8% | |||||||||||||
Zithromax | 15 | 15 | — | 3% | 9 | 10 | (18%) | (18%) | 112 | 82 | 37% | 39% | |||||||||||||
Medrol | 15 | 17 | (11%) | (9%) | 10 | 8 | 33% | 31% | 26 | 25 | 4% | 5% | |||||||||||||
Vfend | 4 | 6 | (21%) | (19%) | 15 | 18 | (15%) | (16%) | 54 | 57 | (7%) | (5%) | |||||||||||||
Panzyga | — | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||
Zyvox | 2 | 3 | (29%) | (27%) | 6 | 13 | (53%) | (53%) | 56 | 42 | 33% | 35% | |||||||||||||
Fragmin | 29 | 29 | (1%) | — | 13 | 14 | (8%) | (9%) | 16 | 15 | 4% | 7% | |||||||||||||
Pfizer CentreOne(e) | 37 | 37 | (2%) | — | 5 | 3 | * | * | 34 | 39 | (13%) | (12%) | |||||||||||||
All other Anti-infectives | 71 | 71 | — | 3% | 24 | 27 | (9%) | (9%) | 213 | 179 | 18% | 21% | |||||||||||||
All other Hospital(d) | 34 | 42 | (17%) | (16%) | 84 | 90 | (7%) | (6%) | 128 | 118 | 9% | 10% | |||||||||||||
Vaccines | $ | 250 | $ | 226 | 10% | 13% | $ | 103 | $ | 92 | 13% | 14% | $ | 446 | $ | 400 | 11% | 15% | |||||||
Prevnar 13/Prevenar 13 | 149 | 143 | 4% | 6% | 97 | 86 | 13% | 14% | 410 | 379 | 8% | 12% | |||||||||||||
Nimenrix | 40 | 29 | 36% | 39% | 5 | 5 | 11% | 15% | 29 | 15 | 91% | 96% | |||||||||||||
All other Vaccines | 61 | 54 | 14% | 17% | 1 | 1 | (24%) | (25%) | 6 | 5 | 26% | 30% | |||||||||||||
Inflammation & Immunology (I&I) | $ | 270 | $ | 325 | (17%) | (15%) | $ | 149 | $ | 151 | (2%) | (2%) | $ | 168 | $ | 182 | (8%) | (1%) | |||||||
Xeljanz | 66 | 45 | 45% | 48% | 54 | 43 | 26% | 26% | 45 | 36 | 27% | 39% | |||||||||||||
Enbrel (Outside the U.S. and Canada) | 154 | 217 | (29%) | (27%) | 75 | 93 | (19%) | (18%) | 117 | 141 | (17%) | (12%) | |||||||||||||
Inflectra/Remsima(c) | 59 | 71 | (16%) | (14%) | 10 | 5 | 84% | 84% | 5 | 5 | 3% | 10% | |||||||||||||
All other I&I | (9 | ) | (7 | ) | (18%) | (22%) | 9 | 10 | (10%) | (11%) | — | — | — | — | |||||||||||
Rare Disease | $ | 161 | $ | 170 | (5%) | (3%) | $ | 120 | $ | 86 | 40% | 40% | $ | 81 | $ | 78 | 5% | 11% | |||||||
Vyndaqel/Vyndamax | 38 | 25 | 53% | 57% | 61 | 12 | * | * | 6 | 4 | 37% | 46% | |||||||||||||
BeneFIX | 20 | 26 | (23%) | (21%) | 17 | 19 | (12%) | (10%) | 19 | 15 | 24% | 32% | |||||||||||||
Genotropin | 32 | 38 | (17%) | (15%) | 25 | 36 | (31%) | (32%) | 16 | 21 | (25%) | (19%) | |||||||||||||
Refacto AF/Xyntha | 39 | 46 | (15%) | (13%) | 9 | 11 | (21%) | (18%) | 23 | 22 | 5% | 9% | |||||||||||||
Somavert | 30 | 31 | (3%) | — | 5 | 4 | 18% | 17% | 4 | 3 | 19% | 30% | |||||||||||||
All other Rare Disease | 3 | 4 | (36%) | (36%) | 5 | 4 | 15% | 16% | 14 | 12 | 14% | 26% | |||||||||||||
UPJOHN(b) | $ | 213 | $ | 217 | (2%) | — | $ | 537 | $ | 572 | (6%) | (6%) | $ | 834 | $ | 1,152 | (28%) | (26%) | |||||||
Lipitor | 35 | 38 | (6%) | (4%) | 43 | 50 | (14%) | (11%) | 302 | 513 | (41%) | (40%) | |||||||||||||
Lyrica | 39 | 45 | (14%) | (12%) | 183 | 189 | (3%) | (3%) | 54 | 63 | (14%) | (13%) | |||||||||||||
Norvasc | 13 | 15 | (11%) | (8%) | 36 | 41 | (12%) | (11%) | 139 | 234 | (41%) | (39%) | |||||||||||||
Celebrex | 5 | 6 | (6%) | (4%) | 75 | 71 | 6% | 5% | 64 | 82 | (22%) | (21%) | |||||||||||||
Viagra | 17 | 8 | * | * | 15 | 15 | (2%) | (2%) | 78 | 82 | (5%) | (4%) | |||||||||||||
Zoloft | 9 | 7 | 28% | 32% | 11 | 12 | (10%) | (10%) | 45 | 38 | 18% | 23% | |||||||||||||
Effexor | 13 | 12 | 14% | 17% | 30 | 27 | 10% | 9% | 18 | 22 | (17%) | (14%) | |||||||||||||
EpiPen(b) | — | — | — | — | — | — | — | — | — | — | — | — | |||||||||||||
Xalatan/Xalacom | 12 | 14 | (9%) | (7%) | 22 | 25 | (11%) | (11%) | 23 | 18 | 29% | 31% | |||||||||||||
All other Upjohn | 67 | 72 | (7%) | (5%) | 121 | 141 | (14%) | (15%) | 112 | 100 | 12% | 13% | |||||||||||||
CONSUMER HEALTHCARE BUSINESS(f) | $ | — | $ | 107 | (100%) | (100%) | $ | — | $ | 85 | (100%) | (100%) | $ | — | $ | 226 | (100%) | (100%) | |||||||
Total Alliance revenues | $ | 266 | $ | 230 | 16% | 18% | $ | 94 | $ | 85 | 10% | 10% | $ | 1 | $ | — | * | * | |||||||
Total Biosimilars(c) | $ | 94 | $ | 95 | — | 2% | $ | 13 | $ | 6 | * | * | $ | 14 | $ | 6 | * | * | |||||||
Total Sterile Injectable Pharmaceuticals(g) | $ | 106 | $ | 114 | (7%) | (5%) | $ | 101 | $ | 108 | (6%) | (6%) | $ | 479 | $ | 424 | 13% | 15% | |||||||
(a) | Total International represents Developed Europe region + Developed Rest of World region + Emerging Markets region. Details for these regions are described in footnotes (h) to (j) below, respectively. |
(b) | Beginning in 2020, Upjohn began managing our Meridian subsidiary, the manufacturer of EpiPen and other auto-injector products, and a pre-existing strategic collaboration between Pfizer and Mylan N.V. for generic drugs in Japan (Mylan-Japan). As a result, revenues associated with our Meridian subsidiary, except for product revenues for EpiPen sold in Canada, and Mylan-Japan, are reported in our Upjohn business beginning in the first quarter of 2020. We have reclassified revenues associated with our Meridian subsidiary and Mylan-Japan from the Hospital and Internal Medicine categories to the Upjohn business to conform 2019 product revenues to the current presentation. |
(c) | Biosimilars are highly similar versions of approved and authorized biological medicines and primarily include revenues from Inflectra/Remsima and Retacrit. |
(d) | Hospital is a business unit that commercializes our global portfolio of sterile injectable and anti-infective medicines. Hospital also includes Pfizer CentreOne(e). All other Hospital primarily includes revenues from legacy Sterile Injectable Pharmaceuticals (SIP) products (that are not anti-infective products) and, to a much lesser extent, solid oral dose products (that are not anti-infective products). SIP anti-infective products that are not individually listed above are recorded in “All other Anti-infectives”. |
(e) | Pfizer CentreOne includes revenues from our contract manufacturing and active pharmaceutical ingredient sales operation, including sterile injectables contract manufacturing, and revenues related to our manufacturing and supply agreements. |
(f) | On July 31, 2019, Pfizer’s Consumer Healthcare business, an over-the-counter medicines business, was combined with GSK’s consumer healthcare business to form a new consumer healthcare joint venture, of which we own 32%. Upon the closing of the transaction, we deconsolidated our Consumer Healthcare business. Our financial results, and our Consumer Healthcare segment’s operating results, for the first quarter of 2019 reflect three months of Consumer Healthcare segment operations, while our financial results for the first quarter of 2020 do not reflect any contribution from the Consumer Healthcare business. |
(g) | Total Sterile Injectable Pharmaceuticals represents the total of all branded and generic injectable products in the Hospital business, including anti-infective sterile injectable pharmaceuticals. |
(h) | Developed Europe region includes the following markets: Western Europe, Scandinavian countries and Finland. |
(i) | Developed Rest of World region includes the following markets: Japan, Canada, South Korea, Australia and New Zealand. |
(j) | Emerging Markets region includes, but is not limited to, the following markets: Asia (excluding Japan and South Korea), Latin America, Eastern Europe, Africa, the Middle East, Central Europe and Turkey. |
* | Indicates calculation not meaningful or result is equal to or greater than 100%. |
Amounts may not add due to rounding. All percentages have been calculated using unrounded amounts. | |
• | the outcome of R&D activities, including, without limitation, the ability to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable pre-clinical and clinical trial results, including the possibility of unfavorable new clinical data and further analyses of existing clinical data; |
• | the risk we may not be able to successfully address all of the comments received from regulatory authorities such as the FDA or the EMA, or obtain approval from regulators, which will depend on myriad factors, including such regulator making a determination as to whether a product’s benefits outweigh its known risks and a determination of the product’s efficacy; regulatory decisions impacting labeling, manufacturing processes, safety and/or other matters; and recommendations by technical or advisory committees, such as ACIP, that may impact the use of our vaccines; |
• | the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; |
• | claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates, including claims and concerns that may arise from the outcome of post-approval clinical trials, which could result in the loss of marketing approval, changes in product labeling, and/or new or increased concerns about the side effects or efficacy of, a product that could affect its availability or commercial potential, such as the update to the U.S. and EU prescribing information for Xeljanz; |
• | the success of external business-development activities, including the ability to identify and execute on potential business development opportunities, the ability to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all, the ability to realize the anticipated benefits of any such transactions, and the potential need to obtain additional equity or debt financing to pursue these opportunities, which could result in increased leverage and impact our credit ratings; |
• | competitive developments, including the impact on our competitive position of new product entrants, in-line branded products, generic products, private label products, biosimilars and product candidates that treat diseases and conditions similar to those treated by our in-line drugs and drug candidates; |
• | the implementation by the FDA and regulatory authorities in certain countries of an abbreviated legal pathway to approve biosimilar products, which could subject our biologic products to competition from biosimilar products, with attendant competitive pressures, after the expiration of any applicable exclusivity period and patent rights; |
• | risks related to our ability to develop and commercialize biosimilars, including risks associated with “at risk” launches, defined as the marketing of a product by Pfizer before the final resolution of litigation (including any appeals) brought by a third party alleging that such marketing would infringe one or more patents owned or controlled by the third party, and access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to the innovator product; |
• | the ability to meet competition from generic, branded and biosimilar products after the loss or expiration of patent protection for our products or competitor products; |
• | the ability to successfully market both new and existing products domestically and internationally; |
• | difficulties or delays in manufacturing, sales or marketing, including delays caused by natural events, such as hurricanes; supply disruptions, shortages or stock-outs at our facilities; and legal or regulatory actions, such as warning letters, suspension of manufacturing, seizure of product, injunctions, debarment, recall of a product, delays or denials of product approvals, import bans or denial of import certifications; |
• | the impact of public health outbreaks, epidemics or pandemics (such as the COVID-19 pandemic) on our operations, including due to travel limitations and stay-at-home or work-from-home orders, manufacturing disruptions or delays, supply chain interruptions, disruptions to pipeline development and clinical trials, decreased product demand, including due to reduced numbers of in-person meetings with prescribers, patient visits with physicians and elective surgeries as well as increased unemployment resulting in lower new prescriptions, challenges presented by reallocating human capital, R&D, manufacturing and other resources to assist in responding to such outbreaks without disruption to our operations, costs associated with the COVID-19 pandemic, including protocols intended to reduce the risk of transmission, increased supply chain costs and additional R&D costs incurred in our effort to develop a potential vaccine or treatment for COVID-19, and other challenges presented by disruptions to our normal operations in response to the pandemic, as well as uncertainties regarding the duration and severity of the pandemic and its impacts and government or regulatory actions to contain the virus or control the supply of medicines, each of which may also amplify the impact of the other factors listed in this section; |
• | uncertainties related to our efforts to develop a potential treatment or vaccine for COVID-19, including that our development programs may not be successful or commercially viable or receive approval from regulatory authorities, any disruption in the relationships between us and our collaboration partners or third-party suppliers, other companies may produce superior or competitive products, the demand for such products may no longer exist, lack of availability of raw materials to manufacture such products, we may not be able to recoup costs associated with our R&D and manufacturing efforts or create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any approved vaccine or product candidate and any pricing and access challenges for such products, including in the U.S.; |
• | trade buying patterns; |
• | the impact of existing and future legislation and regulatory provisions on product exclusivity; |
• | trends toward managed care and healthcare cost containment, and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products; |
• | the impact of any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidized health programs or changes in the tax treatment of employer-sponsored health insurance that may be implemented; |
• | the impact of any U.S. healthcare reform or legislation, including any replacement, repeal, modification or invalidation of some or all of the provisions of the U.S. Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act; |
• | U.S. federal or state legislation or regulatory action and/or policy efforts affecting, among other things, pharmaceutical product pricing, intellectual property, reimbursement or access, including under Medicaid, Medicare and other publicly funded or subsidized health programs; patient out-of-pocket costs for medicines, manufacturer prices and/or price increases that could result in new mandatory rebates and discounts or other pricing restrictions; general budget control actions; the importation of prescription drugs from outside the U.S. at prices that are regulated by governments of various foreign countries; revisions to reimbursement of biopharmaceuticals under government programs; restrictions on U.S. direct-to-consumer advertising; limitations on interactions with healthcare professionals; or the use of comparative effectiveness methodologies that could be implemented in a manner that focuses primarily on the cost differences and minimizes the therapeutic differences among pharmaceutical products and restricts access to innovative medicines; as well as pricing pressures for our products as a result of highly competitive insurance markets; |
• | legislation or regulatory action in markets outside the U.S., including China, affecting pharmaceutical product pricing, intellectual property, reimbursement or access, including, in particular, continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets; |
• | the exposure of our operations outside the U.S. to possible capital and exchange controls, economic conditions, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, as well as political unrest, unstable governments and legal systems and inter-governmental disputes; |
• | contingencies related to actual or alleged environmental contamination; |
• | any significant breakdown, infiltration or interruption of our information technology systems and infrastructure; |
• | legal defense costs, insurance expenses and settlement costs; |
• | the risk of an adverse decision or settlement and the adequacy of reserves related to legal proceedings, including patent litigation, such as claims that our patents are invalid and/or do not cover the product of the generic drug manufacturer or where one or more third parties seeks damages and/or injunctive relief to compensate for alleged infringement of its patents by our commercial or other activities, product liability and other product-related litigation, including personal injury, consumer, off-label promotion, securities, antitrust and breach of contract claims, commercial, environmental, government investigations, employment and other legal proceedings, including various means for resolving asbestos litigation, as well as tax issues; |
• | the risk that our currently pending or future patent applications may not result in issued patents, or be granted on a timely basis, or any patent-term extensions that we seek may not be granted on a timely basis, if at all; |
• | our ability to protect our patents and other intellectual property, both domestically and internationally, including in response to any pressure, or legal or regulatory action by, various stakeholders or governments that potentially results in us not seeking intellectual property protection for or agreeing not to enforce intellectual property related to potential vaccines and treatments for COVID-19; |
• | interest rate and foreign currency exchange rate fluctuations, including the impact of possible currency devaluations in countries experiencing high inflation rates; |
• | governmental laws and regulations affecting domestic and foreign operations, including, without limitation, tax obligations and changes affecting the tax treatment by the U.S. of income earned outside the U.S. that may result from pending and possible future proposals, including further clarifications and/or interpretations of or changes to the Tax Cuts and Jobs Act enacted in 2017; |
• | any significant issues involving our largest wholesale distributors, which account for a substantial portion of our revenues; |
• | the possible impact of the increased presence of counterfeit medicines in the pharmaceutical supply chain on our revenues and on patient confidence in the integrity of our medicines; |
• | uncertainties based on the formal change in relationship between the U.K. government and the EU, which could have implications on our research, commercial and general business operations in the U.K. and the EU, including the approval and supply of our products; |
• | any significant issues that may arise related to the outsourcing of certain operational and staff functions to third parties, including with regard to quality, timeliness and compliance with applicable legal or regulatory requirements and industry standards; |
• | any significant issues that may arise related to our joint ventures and other third-party business arrangements; |
• | further clarifications and/or changes in interpretations of existing laws and regulations, or changes in laws and regulations, in the U.S. and other countries, including changes in U.S. generally accepted accounting principles; |
• | uncertainties related to general economic, political, business, industry, regulatory and market conditions including, without limitation, uncertainties related to the impact on us, our customers, suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions and recent and possible future changes in global financial markets; the related risk that our allowance for doubtful accounts may not be adequate; and the risks related to volatility of our income due to changes in the market value of equity investments; |
• | any changes in business, political and economic conditions due to actual or threatened terrorist activity or civil unrest in the U.S. and other parts of the world, and related U.S. military action overseas; |
• | growth in costs and expenses; |
• | changes in our product, segment and geographic mix; |
• | the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items; |
• | the impact of product recalls, withdrawals and other unusual items; |
• | the risk of an impairment charge related to our intangible assets, goodwill or equity-method investments; |
• | the impact of, and risks and uncertainties related to, acquisitions and divestitures, such as the acquisition of Array, our transaction with GSK which combined our respective consumer healthcare businesses into a new consumer healthcare joint venture and our agreement to combine Upjohn with Mylan to create a new global pharmaceutical company, Viatris, including, among other things, risks related to the satisfaction of the conditions to closing to any pending transaction (including the failure to obtain any necessary shareholder and regulatory approvals) in the anticipated timeframe or at all and the possibility that such transaction does not close; the ability to realize the anticipated benefits of those transactions, including the possibility that the |
• | the impact of, and risks and uncertainties related to, restructurings and internal reorganizations, including the reorganization of our commercial operations in 2019, as well as any other corporate strategic initiatives, and cost-reduction and productivity initiatives, each of which requires upfront costs but may fail to yield anticipated benefits and may result in unexpected costs or organizational disruption. |