Slide 1: Third Quarter 2021 Earnings Teleconference
Third Quarter 2021 Earnings Teleconference November 2, 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 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: Q3 2021 Key Highlights
Q3 2021 Key Highlights Strong Financial Performance Value for Patients Value for Shareholders ~1B $0.39 Approved(2) +130% Total Company 1st +7% ex-Comirnaty (1) Patients • +3% year over year quarterly dividend Operational Revenue Growth reached worldwide YTD 1st with our medicines and • +5% year ove
Slide 6: Q3 2021 Revenues: Comirnaty
Q3 2021 Revenues: Comirnaty(1) Strong Performance Help Ensure We Quickly Respond to the Virus as it Evolves $13B Global Revenue in 3rd Quarter • First, top-line results from our Phase 3 randomized, controlled trial demonstrated that a booster dose administered to individuals 16 years of age 2.6B Dos
Slide 7: Q3 2021 Revenues: Other Key Growth Drivers
Q3 2021 Revenues: Other Key Growth Drivers Revenues Grew 130% Operationally; Grew 7% Op Excluding the Impact of Comirnaty(1) Oncology Biosimilars $1,346M +19% op $501M +42% op(2) $1,381M +1% op $398M +51% op(3) U.S. $629M, +13% U.S. $228M, +44% U.S. $883M, -3% U.S. $284M +65% Int'l $717M, +25% op In
Slide 8: Q3 2021 Revenues: Managing through Challenges
Q3 2021 Revenues: Managing through Challenges Drivers & Next Generation of Innovation Help Offset Challenges Challenge Opportunity • Prevnar Family (Prevnar/Prevenar 13 & 20): 2% decline in U.S. revenue due to 36% decline in Prevnar 13 adult indication • ACIP votes to recommend single dose of Prevna
Slide 9: 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 Approvals: 1 BRAFTOVI & MEKTOVI – Cancer LMNA – Cardiomyopathy Pivotal Starts: 2 FIH: 3(1) Fast Track Designation (FDA) GTx – Wilson Disease F
Slide 10: Welcome to Aamir Malik
Welcome to Aamir Malik Executive Vice President and Chief Business Innovation Officer • In August, joined Executive Leadership Team as Chief Business Innovation Officer • 25 year career at McKinsey & Company where he developed growth strategies, guided mergers and acquisitions, and implemented large
Slide 11: 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 12: Scientific Updates
Scientific Updates Mikael Dolsten Chief Scientific Officer and President, Worldwide Research, Development and Medical
Slide 13: Pfizer Continues to Sustain High End-to-End Clinical Success Rates
Pfizer Continues to Sustain High End-to-End Clinical Success Rates Pfizer vs Industry Average Clinical Success Rates (2020) 85% Industry Pfizer Clinical Phase Success Rates 72% (new molecular entities only) 52% 48% 43% 34% 21% 11% Phase 1 Phase 2 Phase 3/Reg End-to-End 3-year avg. 5-year avg. 5-year
Slide 14: Key Portfolio Updates
Key Portfolio Updates Q3 2021 Earnings Call COMIRNATY F8, F9 & Duchenne High Potency PDE4+ COVID-19 Vaccine Gene Therapy Medical Dermatology TL1A Inhibitor IFN-β Inhibitor Oral Protease Inhibitor Ulcerative Colitis Dermatomyositis COVID-19 PDE4 = phosphodiesterase-4; TL1A = Tumor Necrosis Factor-Lik
Slide 15: COMIRNATY Induced Robust Efficacy in Children 5-11 yrs.
COMIRNATY Induced Robust Efficacy in Children 5-11 yrs. Phase 2/3 Study Comparable Response Observed at 10μg High Vaccine Efficacy Demonstrated at 10μg Wild Type 5-11 yrs. Phase 2/3 study 16-25 yrs. 30 µg 50% Serum Neutralizing Titers 104 10,000 5-11 yrs. 10 µg (N=264) (N=253) COMIRNATY Placebo 1197
Slide 16: Fever & Chills Milder in 5-11yrs. than Adolescent & Adults
Fever & Chills Milder in 5-11yrs. (10μg) than Adolescent & Adults (30μg) 5-11 Years 12-15 Years 16-25 Years N=1511 N=1127 N=531 30 Chills Chills Dose 1 25 20 15 Fever % of Participants 10 Chills Fever Fever 5 0 N=1501 N=1097 N=488 50 Chills Chills 40 Dose 2 30 Fever 20 Fever Chills 10 Fever 0 10 µg
Slide 17: Improved Handling Conditions for 5-11 yr. versus 12+ yr.
Improved Handling Conditions for 5-11 yr. versus 12 + yr. Vial Cap Color Purple Orange Age (in years) 12+ yr. 5 y – 11 yr. Dose 30 µg 10 µg Pack Size 195 Pack 10 Pack Only Doses per Vial 6 doses 10 doses (after dilution) ✓ Up to 9 months ✓ Up to 6 months ULTRA Freezer (-90C to -60C) ✓ Up to 1 month
Slide 18: 3rd Booster Dose Restores High Levels of Vaccine Effectiveness
3rd Booster Dose Restores High Levels of Vaccine Effectiveness Phase 3 booster dose highly effective against symptomatic COVID-191 COMIRNATY Placebo2 (N=4695) (N=4671) Confirmed COVID-193 Confirmed COVID-193 Vaccine Efficacy % (95% CI) 95.6% 5 109 (89.3, 98.6) Real world evidence Israel booster dose
Slide 19: Guidelines Favoring COMIRNATY in Certain Populations
Guidelines Favoring COMIRNATY in Certain Populations1 NORWAY SWEDEN COMIRNATY only Alternate mRNA vaccine paused • 12-15yo (single dose) in patients born 1991 or later • In males <30yo, all <18yo FINLAND UNITED KINGDOM COMIRNATY only in <18yo; COMIRNATY only 12-15yo (single dose) in males born 1991
Slide 20: Pfizer Gene Therapy: Program Updates
Pfizer Gene Therapy: Program Updates Clinical Programs Hemophilia B Hemophilia A Duchenne Muscular Dystrophy • Ph1b: F9 expression of 22% out to yr 4 (n=7) • Ph1b: F8 activity >50% at 78 wks • Ph1b: Robust & durable dystrophin expression at 1 yr ‒ ABR of <1 ‒ ABR<1 throughout1 ‒ Along with functiona
Slide 21: High Potency PDE4+ (PF-07038124) Atopic Dermatitis & Psoriasis
High Potency PDE4+ (PF-07038124) Atopic Dermatitis & Psoriasis PATIENT • Atopic dermatitis & psoriasis are chronic skin disorders driven by inflammation & skin barrier defects • 32M people living with atopic dermatitis (AD) in the US; 8M people living with psoriasis (PsO) in the US • AD & PsO diseas
Slide 22: High Potency PDE4+ Atopic Dermatitis Phase 2a Study
High Potency (Hi Po) PDE4+ Atopic Dermatitis Phase 2a Study Significant Reduction in Eczema Area Severity at Low Dose Potency Against IL-4 & IL-13 – in vitro Clinical Improvement (EASI) – Hi Po PDE4+ vs Comparators1 Hi Po PDE4+ Ph 2a Study (N=36) Comparator Data2,3 Week 2 Week 4 Week 6 Week 4 Week 8
Slide 23: High Potency PDE4+ Psoriasis Phase 2a Study
High Potency (Hi Po) PDE4+ Psoriasis Phase 2a Study Significant Reduction in Psoriasis Area Severity at Low Dose Potency Against IL-23 – Skin Model Clinical Improvement (PASI) – Hi Po PDE4+ vs Comparators1 500 Hi Po PDE4+ Ph 2a Study (N=17) roflumilast Ph 2 Study2 1 400 (Score)1 Week 6 IL-23 RNA Exp
Slide 24: TL1A Inhibitor (PF-06480605) Ulcerative Colitis
TL1A Inhibitor (PF-06480605) Ulcerative Colitis PATIENT • Ulcerative Colitis is a chronic, inflammatory bowel disease that causes inflammation in the digestive tract • ~3M people living with ulcerative colitis in US SCIENCE • TL1A amplifies cytokine production in multiple immune cells where it drive
Slide 25: TL1A Inhibitor Ulcerative Colitis Phase 2a Study
TL1A Inhibitor Ulcerative Colitis Phase 2a Study Improvement in Mayo Score & Potential for Biomarker-Driven Patient Selection to Improve Efficacy Endoscopic Improvement: TL1A Inhibitor (TL1Ai) & tofacitinib Potential Biomarker-Based Patient Selection – Ph 2a 60 60 p=0.04 Endoscopic Improvement2 Endo
Slide 26: Interferon Beta (IFN-β) Inhibitor (PF-06823859) Dermatomyositis
Interferon Beta (IFN-β) Inhibitor (PF-06823859) Dermatomyositis1 PATIENT • Dermatomyositis (DM) is a rare, severely debilitating & life-threatening autoimmune disease affecting skin and muscle • High disease burden, debilitating muscle weakness & rash, cardiac involvement, increased cancer risk & hi
Slide 27: Interferon Beta (IFN-β) Inhibitor: Phase 2 (Part 1)
Interferon Beta (IFN-β) Inhibitor: Phase 2 (Part 1) A Potential Breakthrough Therapy for Dermatomyositis Patients 13 Gene IFN-β Signature (12 wk) Clinical Disease Activity (CDASI-A) 2 - 50 45 Change from Baseline Mean CDASI-A Score 83.6% decrease 40 0 - 35 30 25 -2 - 20 11.8% decrease 15 10 -4 - 5 0
Slide 28: Oral Protease Inhibitor Candidate Targets Patient Populations
Oral Protease Inhibitor Candidate Targets 3 Patient Populations • Oral protease inhibitor binds to SARS-CoV-2 3CL protein and prevents viral replication ‒ Potential for broad coronavirus treatment • Demonstrated strong pre-clinical anti-viral activity against variants of concern • Favorable pre-clin
Slide 29: Recent and Potential Upcoming Milestones
Recent and Potential Upcoming Milestones Select Examples 2021 2022 ● Myfembree uterine fibroids (May-US) ○ COVID-19 oral PI (1H-US/EU) ● Prevnar 20 Adult (Jun-US) ○ Cibinqo (abrocitinib) atopic dermatitis (1H-US) ● COMIRNATY BLA 16+ (Aug-US); EUA 12-15 (May-US); EUA 5-11 (Oct-US) ○ Somatrogon growth
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) $24.1B +130% op $9.9B * $2.7B +5% op $11.1B(1) +7% op(1) 41%(3) +21.8 ppts Primarily driven by Comirnaty(2), Eliquis, Primarily driven by sales of Comirnaty(2) Primarily driven by increased product- Vy
Slide 32: 2021 Financial Guidance
2021 Financial Guidance(1) $81.0 to $82.0 Billion Revenues (previously $78.0 to $80.0 billion) 39.1% to 39.6% Adjusted Cost of Sales(1) as a Percentage of Revenues (previously 39.0% to 40.0%) $11.6 to $12.1 Billion Adjusted SI&A Expenses(1) (previously $11.5 to $12.5 billion) $10.4 to $10.9 Billion
Slide 33: Assumptions Related To Comirnaty within 2021 Financial Guidance
Assumptions Related To Comirnaty(1) within 2021 Financial Guidance(1) • Revenue estimate includes ~2.3B doses expected to be delivered in fiscal 2021 through the end of December for the Approximately $36.0 billion U.S. and through the end of November for the rest of the Revenues for Comirnaty(1) (pr
Slide 34: Selected 2021 Financial Guidance Ranges Excluding Comirnaty
Selected 2021 Financial Guidance(1) Ranges Excluding Comirnaty(1) $45.0 to $46.0 billion Revenue (previously $45.0 to $47.0 billion) Adjusted Cost of Sales(1) as a Percentage of Revenues 21% to 22% $2.60 to $2.65 Adjusted Diluted EPS(1) (previously $2.55 to $2.65) Midpoint of Revenue Range Reflects
Slide 35: 2022 Outlook for Potential Comirnaty Sales
2022 Outlook for Potential Comirnaty(1) Sales 4B Expected doses to be produced in 2022 1.7B Expected doses to be delivered in 2022 based on contracts signed as of mid-October 2021 ~$29B Direct sales and alliance revenues anticipated in 2022 based on contracts signed as of mid-October 2021 We Continu
Slide 36: Capital Allocation Framework
Capital Allocation Framework Achieve Medical Breakthroughs Return Capital to Shareholders R&D Investments Commitment to Dividend • 331 consecutive quarters of dividend payments • Prioritize five core therapeutic areas, and emerging • 12 consecutive years of dividend increases technology platforms •
Slide 37: Key Takeaways
Key Takeaways Delivered a strong quarter: Revenues +130% op • +7% op excluding Comirnaty(1), reflecting 12% volume growth and -5% pricing Raised FY Guidance(1) for Total Company: Revenues $81.0B-$82.0B vs previous $78.0B-$80.0B and Adj. Diluted EPS(1) $4.13-$4.18 vs previous $3.95-$4.05 Key product
Slide 38: Footnotes (Page 1 of 2)
Footnotes (Page 1 of 2) (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 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 third quarter and first nine months for U.S. subsidiaries reflects the three and nine months ended on October 3,
Slide 40: Appendix
Appendix
Slide 41: Appendix – References: Current Vaccine Restrictions
Appendix 1 – References: Current Vaccine Restrictions • Canada - Ontario • https://www.publichealthontario.ca/-/media/documents/ncov/factsheet/2021/01/vac/factsheet-covid-19-vaccines.pdf?sc_lang=en • https://news.ontario.ca/en/statement/1000907/ontario-recommends-the-use-of-pfizer-biontech-covid-19-