Slide 1: Second Quarter 2021 Earnings Teleconference
Second Quarter 2021 Earnings Teleconference July 28, 2021 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 l 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: Q2 2021 Key Highlights
Q2 2021 Key Highlights Strong Financial Performance Pipeline Innovation EU conditional and US Successful Phase 2a st 1 emergency use +86% authorization for COVID-19 vaccine in adolescents human challenge trial with RSV Adult vaccine candidate Operational Revenue Growth Patient dosed in Phase 3 Recru
Slide 6: Q2 2021 Revenues Grew 86% Operationally
Q2 2021 Revenues Grew 86% Operationally Excluding the Impact of BNT162b2(1), Revenues Grew 10% Operationally Pfizer-BioNTech COVID- 19 Vaccine(1) $7,838M $1,481M +13% op $1,404M +2% op(2) $303M +14% U.S. U.S. $2,034M U.S. $831M, +15% U.S. $862M, -7% $123M ex-U.S. royalty income Int'l $5,804M Int'l $
Slide 7: JAK Inhibitor Portfolio
JAK Inhibitor Portfolio Supporting Patients with Inflammatory Diseases • Global Q2 2021 operational revenue decreased 9% YoY ◦ U.S. operational revenue declined 15%, despite ~2% YoY growth in prescription volume ▪ Unfavorable change in channel mix toward lower-priced channels ▪ Continued formulary a
Slide 8: Affordable Access
Affordable Access On Biden Administration's recent Executive Order promoting competition • Any regulatory or legislative action should: ◦ Foster competition ◦ Lower costs for patients Meaningful solutions for patient access without sacrificing innovation • Rebate reform • Capping beneficiary cost-sh
Slide 9: Looking Ahead
Looking Ahead Driving Operational Excellence • Investing in areas where we can win • Scaling emerging technology platforms • Maintaining patient centricity and the highest quality standards • Reducing approval development cycle times • Fostering a culture of innovation The New Pfizer • Focused, Inno
Slide 10: Scientific Updates
Scientific Updates Mikael Dolsten Chief Scientific Officer and President, Worldwide Research, Development and Medical
Slide 11: First in Class Science Updates (Q2 2021)
First in Class Science Updates (Q2 2021) ER PROTAC ROBO2 Biological Factor 8, Factor 9 & DMD Lyme Breast Cancer Kidney Disease Gene Therapy Vaccine RSV Adult mRNA Flu COVID-19 Oral Protease Vaccine Vaccine Vaccine COVID-19 ER: estrogen receptor; PROTAC: PROteolysis TArgeting Chimera; ROBO2: Roundabo
Slide 12: First in Class Science: ARV-471 PROTAC in Breast Cancer
First in Class Science: ARV-471 PROTAC1 in Breast Cancer PATIENT • In 2021, >1.6 M people globally expected to be diagnosed with ER+ Breast Cancer; ~280K in US1 • 50K pts/yr in US with metastatic breast cancer (mBC), and 160K/yr with early breast cancer (adjuvant opportunity) • In women, breast canc
Slide 13: ARV-471: Potential First Oral PROTAC for Breast Cancer
ARV-471: Potential First Oral PROTAC for Breast Cancer Compelling Pre-clinical & Clinical Data Pre-clinical: Synergistic activity in Phase 1 Clinical: Confirmed partial response in a combination with palbociclib patient with extensive prior treatment1 Baseline CT Scan After 4 Cycles Mean tumor Volum
Slide 14: First in Class Science: ROBO2 Ligand Trap Biological in Kidney Disease
First in Class Science: ROBO2 Ligand Trap Biological in Kidney Disease PATIENT • Focal segmental glomerulosclerosis (FSGS), is a rare, progressive, kidney disease (US Prevalence ~40K1) - Over 60% of patients progress to end-stage renal disease within 5-10 years SCIENCE • Potential first-in-class, no
Slide 15: ROBO2 Ligand Trap Biological: Phase 2a Study
ROBO2 Ligand Trap Biological: Phase 2a Study1 Reduction in Proteinuria in Focal Segmental Glomerulosclerosis Patients Urine Protein:Creatinine Ratio (UPCR) Change from Baseline in Steroid/Treatment-Resistant Patients 60 Baseline UPCR: 5.4 g/g Estimated % Change from Baseline N=9 LS Mean in UPCR (90%
Slide 16: First in Class Science: Leading Gene Therapy Programs
First in Class Science: Leading Gene Therapy Programs PATIENT: • Hemophilia: strong need to manage disease without regular infusions - Hem A: F8 deficient, ~28K Males (US)1 - Hem B: F9 deficient, ~6K males (US)1 • DMD: Reduced dystrophin level driving muscle degeneration; ~13K patients (US)2 SCIENCE
Slide 17: Gene Therapy: Positive Data from Phase 1/2 to Support Phase 3 Programs
Gene Therapy: Positive Data from Phase 1/2 to Support Phase 3 Programs Hemophilia A Hemophilia B Duchenne 200 Mean=22.8 Mean=26.5 Mean=23.3 Mean=21.9 2200 60 70 Mean Total Dystrophin (fmol/mg) High dose 2000 Factor IX Activity (% Normal) Factor VIII Activity (% Normal) 65 Mean % Normal Dystrophin Lo
Slide 18: First in Class Science: Lyme Vaccine
First in Class Science: Lyme Vaccine 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 200K cases in Europe annually2 - Untreate
Slide 19: Lyme Vaccine Phase 2 Data: >90% Seroconvert All 6 Serotypes
Lyme Vaccine1 Phase 2 Data: >90% of Subjects Seroconvert All 6 Serotypes Seroconversion Rate2: 0, 2, 6 vs 0, 1, 2 Month Regimen 180μg dose – 1 Month Post Dose 3 100 Serological Conversion 80 Rate (%) 60 40 20 0 Serotype Serotype Serotype Serotype Serotype Serotype 1 2 3 4 5 6 VLA15 0, 1, 2 Month Reg
Slide 20: First in Class Science: RSV Adult Vaccine
First in Class Science: RSV Adult Vaccine PATIENT • Globally disease develops in > 5% older adults annually and up to 10% in younger high-risk adults1 • Above 60 years of age constitute a high-risk group for RSV illness with 15K deaths in US annually2 SCIENCE • The prefusion conformation of the RSV
Slide 21: RSV Adult Vaccine: Phase 2 Human Challenge Data
RSV Adult Vaccine: Phase 2 Human Challenge Data 100% Vaccine Efficacy Achieved in Adults 18–50-years-old Change in Viral Load Change in Disease Severity Vaccine Group: RSV Vaccine (N=31) Placebo (N=31) 4 3 (Total Symptom Score) Disease Severity (log10 copies/mL) Mean Viral Load 3 2 2 1 1 0 0 0 3 6 9
Slide 22: Pfizer's mRNA Strategy
Pfizer’s mRNA Strategy Invest to Strengthen Grow Prophylactic Explore TAs with Wait to De-risk for Core Franchise Vaccines Strongest Benefit/Risk Larger Indications Rare Disease COVID-19 (e.g., going beyond Inflammation & Immunology Flu* Vaccine(s)* CRISPR with base editing) (e.g., immuno-tolerance)
Slide 23: First in Class Science: Flu Vaccine
First in Class Science: Flu Vaccine PATIENT • During 2018-2019 US season ~36M cases were recorded, resulting in ~400K hospitalizations, and ~34K deaths1 • Current flu vaccines have variable effectiveness that can range from ~23-60%1,2 SCIENCE • Modified RNA (modRNA) flu vaccine based on proven BNT16
Slide 24: Pre-clinical Data: First Generation modified RNA Flu
Pre-clinical Data: First Generation (Pre-COVID-19) modified RNA Flu H1N1 H3N2 B-Victoria B-Yamagata 10 4 10 5 10 5 10 5 H1N1 H3N2 B-Victoria B-Yamagata Titers (A/Michigan/45/2015) (A/Singapore/INFIMH-16-0019/2016) (B/Colorado/06/2017) (B/Phuket/3073/2013) Neutralization Titers 10 4 10 4 10 4 Neutral
Slide 25: First in Class Science: Pfizer-BioNTech COVID-19 Booster Vaccine
First in Class Science: Pfizer-BioNTech COVID-19 Booster Vaccine PATIENT • Emergence of Delta variant, and the associated rapidly increasing infections, represents ~83% of sequenced cases in the US1 • Regulators would determine whether, and which, populations to recommend booster1 - Likely to first
Slide 26: COVID-19 Vaccine: Neutralization Titers Much Higher Post 3rd Dose
COVID-19 Vaccine: Neutralization Titers Much Higher Post 3rd Dose Than Post 2nd for Wild Type and Beta Variants1,2 18-55 y/o (n=11/gp) 65-85 y/o (n=12/gp) 1.0 0.30 0.27 0.48 0.69 0.73 1.0 0.27 0.29 0.49 0.67 0.77 *GMRBeta/WT PRNTWT 2119 2032 50% serum neutralizing titer 10 4 1754 1546 PRNTBeta 1202
Slide 27: COVID-19 Vaccine: 3rd Dose Strongly Boosts Neutralizing Titers Against Delta Strain
COVID-19 Vaccine: 3rd Dose Strongly Boosts Neutralizing Titers Against Delta Strain1,2 PRNTWT PRNTDelta GMRDelta/WT • Post dose 3 titers vs. the Delta variant are >5-fold post dose 2 titers in 18-55 y/o & >11-fold post dose 2 titers in 65-85 y/o • Estimated potential for up to 100-fold increase in D
Slide 28: First in Class Science: Oral COVID-19 Protease Inhibitor
First in Class Science: Oral COVID-19 Protease Inhibitor PATIENT • High SARS-CoV-2 mutational rate, continued global impact & vaccine hesitancy creates likely sustained need for therapeutic • Addressable market may be up to 100s of millions of patients which include high risk, low risk and close con
Slide 29: Oral Protease Inhibitor Shows Robust Preclinical Anti-viral Effects
Oral Protease Inhibitor Shows Robust Preclinical Anti-viral Effects and Good Preliminary Human Pharmacokinetics Profile Preclinical Histopathology Score Suggests Multiple Ascending Dose Dose Dependent Efficacy Preliminary Pharmacokinetics Profile in Humans 8 **p=0.0068; ****p<0.001 Histopathology Sc
Slide 30: Financial Review
Financial Review Frank D'Amelio Chief Financial Officer and Executive Vice President, Global Supply
Slide 31: Quarterly Income Statement Highlights
Quarterly Income Statement Highlights Revenues Adjusted Cost of Sales(2) Adjusted SI&A Expenses(2) $19.0B +86% op $7.0B +267% op $2.8B +8% op $11.1B(1) +10% op(1) 37%(3) +18.7 ppts Primarily driven by BNT162b2(2), Primarily reflecting increased product- Vyndaqel, Eliquis, Prevnar 13 in U.S., related
Slide 32: 2021 Financial Guidance
2021 Financial Guidance(1) $78.0 to $80.0 Billion Revenues (previously $70.5 to $72.5 billion) 39.0% to 40.0% Adjusted Cost of Sales(1) as a Percentage of Revenues (previously 38.0% to 39.0%) $11.5 to $12.5 Billion Adjusted SI&A Expenses(1) (previously $11.0 to $12.0 billion) $10.0 to $10.5 Billion
Slide 33: Assumptions Related To BNT162b2 within 2021 Financial Guidance
Assumptions Related To BNT162b2(1) within 2021 Financial Guidance(1) • Revenue estimate reflects 2.1B doses expected to be delivered in 2021 under contracts signed through mid-July(2) Approximately $33.5 billion Revenue assumption could change if additional contracts Revenues for BNT162b2(1) (previo
Slide 34: Selected 2021 Financial Guidance Ranges Excluding BNT162b2
Selected 2021 Financial Guidance(1) Ranges Excluding BNT162b2(1) $45.0 to $47.0 billion Revenue (previously $44.6 to $46.6 billion) Adjusted Cost of Sales(1) as a Percentage of Revenues 21% to 22% $2.55 to $2.65 Adjusted Diluted EPS(1) (previously $2.50 to $2.60) Midpoint of Revenue Range Reflects ~
Slide 35: Capital Allocation Framework
Capital Allocation Framework Achieve Medical Breakthroughs Return Capital to Shareholders R&D Investments Commitment to Dividend • Prioritize five core therapeutic areas and emerging • 330 consecutive quarters of dividend payments technology platforms • 12 consecutive years of dividend increases • E
Slide 36: Key Takeaways
Key Takeaways Delivered a strong quarter: Revenues +86% op • +10% op excluding BNT162b2(1), reflecting 14% volume growth and -4% pricing Raised FY Guidance(1): Revenues $78.0B-$80.0B vs previous $70.5B-$72.5B and Adj. Diluted EPS(1) $3.95-$4.05 vs previous $3.55-$3.65 Key product and pipeline milest
Slide 37: Q&A Session
Second Quarter 2021 Earnings Teleconference Q&A Session July 28, 2021 Breakthroughs that change patients' lives ®
Slide 38: Footnotes (Page 1 of 2)
Footnotes (Page 1 of 2) (1) BNT162b2 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 BNT162b2 manufacturing activities performed
Slide 39: Footnotes (Page 2 of 2)
Footnotes (Page 2 of 2) (5) 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 second quarter and first six months for U.S. subsidiaries reflects the three and six months ended on July 4, 202