Slide 1: Fourth Quarter 2021 Earnings Teleconference
Fourth Quarter 2021 Earnings Teleconference February 8, 2022 Breakthroughs that change patients' lives ®
Slide 2: Introduction
Introduction Christopher Stevo Senior Vice President, Chief Investor Relations Officer
Slide 3: Forward-Looking Statements and Non-GAAP Financial Information
Forward-Looking Statements and Non-GAAP Financial Information Our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such sta
Slide 4: Opening Remarks
Opening Remarks Albert Bourla Chairman and Chief Executive Officer
Slide 5: FY 2021 Key Highlights
FY 2021 Key Highlights Strong Financial Performance Leading in Patient Centricity and Brand Reputation st #2 among largeApproved +92% biopharma companies 1 (2) ~1.4B Patients (PatientView Global Survey) 61% of Americans have favorable Total Company 1streached worldwide in 2021 view of Pfizer, up 33
Slide 6: FY 2022 Total Company Guidance
FY 2022 Total Company Guidance(1) $98.0B-$102.0B $6.35-$6.55 Revenue Adj. Diluted EPS Record high forecast midpoint Record high forecast midpoint $100B $6.45 (1) See Slides 47-49 for definitions and for additional information regarding Pfizer's 2022 financial guidance Fourth Quarter 2021 Earnings 6
Slide 7: COVID-19 Vaccinations: U.S. Patient and Economic Estimated Impact
COVID-19 Vaccinations: U.S. Patient and Economic Estimated Impact Public Health Impact Economic Impact >1 Million Deaths prevented $438B 2.3% As of December 2021, more than 1 million deaths have been prevented Savings for the of 2021 U.S. by COVID-19 vaccination among vaccinated people.(1) economy i
Slide 8: Long-term Expectations for COVID-19
Long-term Expectations for COVID-19 Our scientists continue to monitor the SARS-CoV-2 virus and believe it is unlikely to be fully eradicated in the foreseeable future. They believe this for several reasons: Global distribution Virus able to mutate often, Natural infection does not prevent all of vi
Slide 9: Tools to Help Manage Pandemic and Move into Endemic Phase
Tools to Help Manage Pandemic and Move into Endemic Phase Pfizer Share = ~71% Fourth Quarter 2021 Earnings 9
Slide 10: Bringing These Tools to the World
Bringing These Tools to the World COMIRNATY Doses Distributed (US+EU)(1) PAXLOVID Manufacturing Capacity (1) Our World in Data Coronavirus (COVID-19) Vaccinations, as of February 5, 2022 (2) “Other” includes Moderna and Johnson & Johnson COVID-19 vaccines Fourth Quarter 2021 Earnings 10
Slide 11: Maintaining Leadership in COVID-19
Maintaining Leadership in COVID-19 What We're Doing Now What We Will Keep Doing in the Future • Test different versions of the COVID-19 vaccine: • Significant investments in R&D – Omicron-based • Move at the speed of science without sacrificing quality or safety – Bivalent • Maintain strong relation
Slide 12: Pfizer's Capital Allocation Strategy (1 of 2)
Pfizer's Capital Allocation Strategy (1 of 2) • Pfizer anticipated to continue to be a growth company from 2025-2030, driven by: – Durable COVID-19 revenues – Internal pipeline – Business development Fourth Quarter 2021 Earnings 12
Slide 13: Pfizer's Capital Allocation Strategy (2 of 2)
Pfizer's Capital Allocation Strategy (2 of 2) • Strong balance sheet & anticipated near-term incremental FCF(1) expected to allow Pfizer to continue growing dividend & pursue new business development (BD) – Potentially generate at least $25B in incremental 2030 risk-adjusted revenues • Disciplined a
Slide 14: Pfizer's mRNA Strategy Roadmap
Pfizer’s mRNA Strategy Roadmap Harness the power of mRNA to address the greatest unmet needs for patients with breakthrough medicines Invest to Strengthen Grow Prophylactic Pursue Additional TAs with Explore opportunities in Core Franchise Vaccines* Strongest Benefit/Risk larger indications COVID-19
Slide 15: Four Recent Agreements that Will Help Advance our mRNA Strategy
Four Recent Agreements that Will Help Advance our mRNA Strategy 1 2 Collaboration agreement to co-develop Collaboration for 3 Rare Diseases mRNA Shingles (HZV) Vaccine (CNS, muscular, liver) 3 4 Collaboration & Option to non-exclusively license Research collaboration / license for LNP technology for
Slide 16: Bolstering the Pipeline with Recent Business Development Opportunities
Bolstering the Pipeline with Recent Business Development Opportunities Select Examples Year Therapeutic Area Organization Asset/Indication Status Since Close BRAFTOVI & MEKTOVI – Cancer; LMNA – Cardiomyopathy Approvals: 1; Pivotal Starts: 2; FIH: 3(1) GTx – Wilson Disease Fast Track Designation (FDA
Slide 17: Pfizer's ESG Strategy: Creating Value for Multiple Stakeholders (1 of 2)
Pfizer's ESG Strategy: Creating Value for Multiple Stakeholders (1 of 2) Product Innovation Equitable Access and Pricing Product Quality and Safety Diversity, Equity, and Inclusion Climate Change Business Ethics Fourth Quarter 2021 Earnings 17
Slide 18: Pfizer's ESG Strategy: Creating Value for Multiple Stakeholders (2 of 2)
Pfizer's ESG Strategy: Creating Value for Multiple Stakeholders (2 of 2) Clinical Trial Diversity(1) Colleague Diversity at VP+ Pfizer U.S. trials from U.S. census level 2011-2020 Black or African-American 14.3% 13.4% Hispanic or Latino 15.9% 18.5% Female 51.1% 50.8% Equitable Access • On track to d
Slide 19: An Outstanding Year Made Possible by Outstanding People
An Outstanding Year Made Possible by Outstanding People Delivering Breakthroughs for Patients • Applying "lightspeed" principles to all our therapeutic areas • Remaining focused on being nimble • Investing in our R&D organization • Exploring dynamic partnerships Made Possible by Purpose-Driven Colle
Slide 20: Scientific Updates
Scientific Updates Mikael Dolsten Chief Scientific Officer and President, Worldwide Research, Development and Medical
Slide 21: Advancing Breakthroughs at the Speed of Science
Advancing Breakthroughs at the Speed of Science Q4 2021 Earnings Call COVID-19 Science Areas Oral Protease inhibitor mRNA Vaccine Core Scientific Areas: Select Pipeline Assets Next-gen CDKi’s Lyme Disease DMD Gene Therapy ponsegromab danuglipron Breast Cancer Vaccine Duchenne Cancer Cachexia Type 2
Slide 22: PAXLOVID: Preclinical Data on SARS-CoV-2 Variants
PAXLOVID: Preclinical Data on SARS-CoV-2 Variants Crystal Structure of PAXLOVID Binding to Omicron1 Preclinical in vitro Data Against Variants2 Variant Antiviral Activity in Vero (First Country Identified) Cells ‒ EC50 Washington (Wuhan) 38 nM Alpha (UK) 41 nM Beta (South Africa) 127 nM Gamma (Brazi
Slide 23: External in vitro Data on Key Therapeutics Against Variants
External in vitro Data on Key Therapeutics Against Variants Antiviral Activity in HeLa-ACE2 Cells – Mt. Sinai, NY Antiviral Activity in VeroE6-GFP Cells – REGA, Belgium 12 10 8 4 1 EC50 (µM) IC50 (µM) 0.8 0.6 0.1 0.4 0.2 4 4 4 6 22 14 6 2 2 ND 6 2 2 2 4 4 ND 4 0.01 Alpha Beta Gamma Omicron Beta Gamm
Slide 24: PAXLOVID: Target Populations for Clinical Studies
PAXLOVID: Target Populations for Clinical Studies High Risk Household Contact Standard Risk Pediatric Pivotal Study EPIC-HR EPIC-PEP EPIC-SR EPIC-Pediatric Target “N” 2246 ~2660 ~1960 ~1001 Current Status EUA Granted (US/EU) Ph 2/3 Ongoing Ph 2/3 Ongoing Doses Identified Anticipated NDA Decision Ant
Slide 25: NextGen SARS-CoV-2 Anti-Viral Oral Candidate
NextGen SARS-CoV-2 Anti-Viral Oral Candidate Key Targeted Features • Maintain clinical efficacy and safety seen with PAXLOVID - Counter potential viral resistance - No ritonavir boost • Maintain in vitro pan-coronavirus activity as with PAXLOVID • Lead candidates identified; FIH anticipated 2H 2022
Slide 26: COMIRNATY: Pediatric (6 months through 4 years) Update
COMIRNATY: Pediatric (6 months through 4 years) Update Jan 31, 2022✔ Feb 1, 2022 ✔ Feb 15, 2022 End of Q1 2022 Initiate 3rd dose evaluation EUA rolling submission: FDA VRBPAC Anticipated FDA EUA in pivotal study 2-dose data to start committee meeting decision1 on 2-dose data • Anticipate need for a
Slide 27: COMIRNATY: Rise of Neutralizing Titers Against Omicron After 3rd Dose
COMIRNATY: Rise of Neutralizing Titers Against Omicron After 3rd Dose1 2-4 Weeks After Dose 2 Day of Dose 32 1 Month After Dose 3 4 Months After Dose 3 1342 336 50% Plaque Neutralizing Titers (log2) 10240 511 20 10240 65 13 10240 10240 820 171 5120 5120 5120 5120 2560 2560 2560 2560 1280 1280 1280 1
Slide 28: COMIRNATY: Omicron-Related Emergency Visits & Hospital Admissions
COMIRNATY: Omicron-Related Emergency Visits & Hospital Admissions Kaiser Permanente Southern California1 Delta (n=1509) Omicron (n=1543) Dec 1, 2021 through Jan 11, 2022 Adjusted Vaccine Effectiveness (%) (95% confidence interval)2 Emergency Department Visit Without Hospitalization 2 doses <3 months
Slide 29: Omicron-Based Vaccine Candidate Study
Omicron-Based Vaccine Candidate Study Study Will Evaluate Safety & Immunogenicity in ~1,400 Participants 18-55 Yrs. Old Omicron-based Omicron-based Omicron-based vaccine vaccine vaccine or or Cohort #1 Cohort #2 Cohort #3 (n = ~600) (n = ~600) (n = ~200) • Received two doses of the current • Receive
Slide 30: CDK2/4/6 Inhibitor: Ph 1 Study Subset in HR+ Metastatic Breast Cancer
CDK2/4/6 Inhibitor: Ph 1 Study Subset in HR+ Metastatic Breast Cancer Inhibition of CDK 2, 4, & 6 May Prevent, Delay, or Reverse Resistance & Prolong Survival Change from Baseline1 in Heavily Pre-treated Patients – Single-Agent or Combo with fulvestrant (n=33) Part 1A 25 mg BID (N=4) Part 1A 50 mg B
Slide 31: CDK2 Inhibitor: Ph 1 Study in Breast Cancer
CDK2 Inhibitor: Ph 1 Study in Breast Cancer Selective CDK2i Inhibition May Allow Dose Titration in Breast Cancer Patients Confirmed Partial Response in Patient 1 Baseline CDK2i at Week 8 Scans courtesy of Dr. Dejan Juric • Patient 1: Confirmed Partial Response (maximum tumor shrinkage -54%); on trea
Slide 32: Lyme Vaccine (PF-07307405) Candidate: Lyme Disease
Lyme Vaccine (PF-07307405) Candidate: Lyme Disease PATIENT • Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks • ~ 476K Americans are diagnosed and treated for Lyme disease each year1, and a further 130K cases in Europe annual
Slide 33: Lyme Vaccine: Ph 2 Data
Lyme Vaccine: Ph 2 Data1 Robust Vaccine Boost 1 yr. after Primary Series; Preferred Primary Series Identified Lyme is Seasonal Disease VLA15 Induces Robust Boostable Antibody Responses 51-69 fold-rise Anti-OspA IgG Geometric Mean 14-31 fold-rise Number of cases 1000 Titer (ELISA U/mL) 100 Baseline S
Slide 34: Fordadistrogene movaparvovec GTx1: Duchenne Muscular Dystrophy
Fordadistrogene movaparvovec GTx1: Duchenne Muscular Dystrophy (DMD) PATIENT • DMD is a genetic disorder characterized by muscle degeneration due to mutations in gene encoding dystrophin • Most common form of muscular dystrophy in childhood; affects 1 in 3,500 male births worldwide (10–12K patients
Slide 35: Fordadistrogene movaparvovec: Ph 1b Ambulatory Population at 1 yr.
Fordadistrogene movaparvovec: Ph 1b Ambulatory Population at 1 yr. Potential Benefit with Manageable Safety Profile North Star Ambulatory Assessment Total Score at 1 Year Time in Study of Ambulatory Boys with DMD 3 Time in Study (Months) Change from baseline in NSAA 0 6 12 18 24 30 36 42 48 2 1 1 2
Slide 36: Anti-GDF-15 mAb (ponsegromab): Cancer Cachexia
Anti-GDF-15 mAb (ponsegromab, PF-06946860): Cancer Cachexia • Cachexia is a complex, life-threatening metabolic condition PATIENT - Causes unintentional weight loss, loss of appetite, muscle wasting and fatigue in many advanced chronic diseases • ~0.5M people per year suffer from cancer cachexia syn
Slide 37: Anti-GDF-15 mAb: Ph 1b Data in Cancer Cachexia
Anti-GDF-15 mAb: Ph 1b (Preliminary Data) in Cancer Cachexia Significant Increases in Body Weight Demonstrate Target Mediated Efficacy Increased body weight: anti-GDF-15 mAb versus placebo1 * * 10 * p = 0.05 * Change from Baseline 8 * * Weight (kg) 6 Historical Cut-off 4 5% Associated with 2 Improve
Slide 38: Oral GLP-1 Receptor Agonist (danuglipron): T2DM & Obesity
Oral GLP-1 Receptor Agonist (danuglipron, PF-06882961): T2DM & Obesity PATIENT • T2DM & Obesity are reaching epidemic levels and are key risk factors for Cardiovascular (CV) Disease & NASH • 34M T2DM & 110M Obese (BMI > 30) patients in the US alone1,2 SCIENCE • GLP-1 RAs offer compelling diabetes an
Slide 39: Danuglipron (Oral GLP-1): Ph 2 Study in Type 2 Diabetes
Danuglipron (Oral GLP-1): Ph 2 Study in Type 2 Diabetes Potential for Best-in-Class Oral Type 2 Diabetes and Weight Loss Efficacy Decrease in HbA1c after 12 week Treatment 1 Reduction in Body Weight after 12-week Treatment 1 Placebo danuglipron 200 mg BID Placebo PBO danuglipron 200 mg BID 0 200 0 2
Slide 40: Key 2H 2021 Achievements and 2022 Milestones
Key 2H 2021 Achievements and 2022 Milestones Select Examples Only 2H 2021 2022 ● COMIRNATY BLA 16+ (Aug-US); EUA 12-15 (May-US); EUA 5-11 (Oct-US) ● CIBINQO atopic dermatitis (Jan-US) ● PAXLOVID High Risk CMA (Jan-EU) ● COMIRNATY booster EUA 65+ & 18-64 high risk (Sept-US) / CMA 18+ (Oct-EU) Key Reg
Slide 41: Financial Review
Financial Review Frank D'Amelio Executive Vice President, Chief Financial Officer
Slide 42: Quarterly Income Statement Highlights
Quarterly Income Statement Highlights Revenues Adjusted Cost of Sales(1) Adjusted SI&A Expenses(1) $23.8B +106% op $9.7B * $3.9B +10% op Primarily driven by Comirnaty(1), Eliquis, Oncology Biosimilars, Vyndaqel, Pfizer 41%(3) +16.3 ppts CentreOne, Paxlovid and Xeljanz Primarily driven by sales of Co
Slide 43: 2021 Financial Guidance vs. Results
2021 Financial Guidance vs. Results Guidance Results Revenues $81.0 to $82.0 billion $81.3 billion Adjusted Cost of Sales(1) as a Percentage of Revenues 39.1% to 39.6% 37.7% Adjusted SI&A Expenses(1) $11.6 to $12.1 billion $12.1 billion Adjusted R&D Expenses(1) $10.4 to $10.9 billion $10.5 billion A
Slide 44: 2022 Financial Guidance
2022 Financial Guidance(1) Revenues $98.0 to $102.0 Billion Adjusted Cost of Sales(1) as a Percentage of Revenues 32.2% to 34.2% Adjusted SI&A Expenses(1) $12.5 to $13.5 Billion Adjusted R&D Expenses(1) $10.5 to $11.5 Billion Adjusted Other (Income)/Deductions(1) Approximately $1.8 billion of income
Slide 45: Capital Allocation Framework
Capital Allocation Framework Achieve Medical Breakthroughs Return Capital to Shareholders R&D Investments Commitment to Dividend • 332 consecutive quarters of dividend payments • Prioritize six core therapeutic areas, and emerging • 12 consecutive years of dividend increases technology platforms • P
Slide 46: Key Takeaways
Key Takeaways Delivered a strong quarter and year: Revenues +106% op in Q4 2021 and +92% op in FY 2021. • +6% op excluding Comirnaty(1) and Paxlovid in FY 2021, reflecting +9% volume growth and -4% pricing(2) Provided full year guidance(1) for Total Company: Revenues $98.0B-$102.0B and Adj. Diluted
Slide 47: Footnotes (Page 1 of 3)
Footnotes (Page 1 of 3) (1) Comirnaty includes direct sales and alliance revenues related to sales of the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, which are recorded within Pfizer’s Vaccines therapeutic area. It does not include revenues for certain Comirnaty-related manufacturing activities
Slide 48: Footnotes (Page 2 of 3)
Footnotes (Page 2 of 3) ▪ Exchange rates assumed are as of mid-January 2022. Financial guidance reflects the anticipated unfavorable impact of approximately $1.1 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.
Slide 49: Footnotes (Page 3 of 3)
Footnotes (Page 3 of 3) ▪ On April 9, 2020, Pfizer signed a global agreement with BioNTech to co-develop a first-in-class, mRNA-based coronavirus vaccine program, BNT162, aimed at preventing COVID-19 infection. In connection with the agreement, Pfizer paid BioNTech an upfront cash payment of $72 mil