Slide 1: Year-to-date and Q3 2021 results
Year-to-date and Q3 2021 results Conference call and webcast for investors and analysts 12 November 2021
Slide 2: Forward-looking statements
Forward-looking statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter ‘the Group’) provides the following cautionary statement: this document contains certain forward-looking statements wit
Slide 3: Speakers
Pascal Soriot Aradhana Sarin Executive Director and Executive Director and Chief Executive Officer Chief Financial Officer Dave Fredrickson Susan Galbraith Executive Vice President, Executive Vice President, Oncology Business Oncology R&D Speakers Ruud Dobber Mene Pangalos Executive Vice President,
Slide 4: Agenda
1 Opening remarks Agenda 2 Financial results 3 Oncology BioPharmaceuticals, 4 Emerging Markets 5 Rare Disease 6 Closing remarks and Q&A 4
Slide 5: Opening remarks
1 Opening remarks Pascal Soriot Chief Executive Officer 5
Slide 6: Year to date and Q3 2021: key highlights
Year to date and Q3 2021: key highlights Positioned for long term sustainable growth Robust growth Broad-based performance Following the science Commercial execution Delivering value to patients Multiple positive Phase III results • Total Revenue $25,406m (+28%) • Oncology $9,744m (+16%) • Lynparza
Slide 7: Year to date and Q3 2021: performance
Year to date and Q3 2021: performance Oncology, CVRM and Respiratory & Immunology all delivered double digit growth Growth Growth across disease areas across geographies (excluding COVID-19 vaccine) YTD ‘21 growth Q3 ‘21 growth YTD ‘21 growth Q3 ‘21 growth $m % $m % $m % $m % Oncology 9,744 16 3,383
Slide 8: Late-stage pipeline delivery
Late-stage pipeline delivery Important milestones since H1 2021 update Medicine Indication (geography) Regulatory Forxiga chronic kidney disease (EU, JP) approvals or other roxadustat anaemia in CKD: complete response letter (US) regulatory action Saphnelo (anifrolumab) systemic lupus erythematosus
Slide 9: Financial results
2 Financial results Aradhana Sarin Chief Financial Officer
Slide 10: Reported profit and loss
Reported profit and loss YTD 2021 change % total Q3 2021 change % total $m % revenue $m % revenue Total revenue 25,406 28 100 9,866 48 100 - product sales 25,043 29 99 9,741 47 99 - collaboration revenue 363 10 1 125 115 1 Gross margin 68.8% (10.7) pp 61.4% (17.5) pp Operating expenses1 17,591 34 69
Slide 11: Core profit and loss
Core profit and loss YTD 2021 change % total Q3 2021 change % total $m % revenue $m % revenue Total revenue 25,406 28 100 9,866 48 100 - product sales 25,043 29 99 9,741 47 99 - collaboration revenue 363 10 1 125 115 1 Gross margin 74.1% (5.8) pp 74.5% (4.7) pp Operating expenses1 13,649 20 54 5,138
Slide 12: Core operating profit mix and full-year 2021 guidance
Core operating profit mix and full-year 2021 guidance Continued improvement in the core operating mix Core operating profit mix Full-year 2021 guidance1 (CER) $m 2,750 2,500 Total Revenue 2,250 2,000 Increase by a low-twenties percentage 1,750 excluding COVID-19 vaccine 1,500 Increase by a mid-to-hi
Slide 13: Net debt and capital allocation priorities
Net debt and capital allocation priorities Rapid debt reduction a priority post Alexion transaction Net debt Capital allocation priorities Net debt: $24,673m; EBITDA: $7,970m $bn • Strong investment grade credit rating • Reinvestment in the business • Value-enhancing business development • Progressi
Slide 14: Oncology
3 Oncology Dave Fredrickson EVP Oncology Business Susan Galbraith EVP Oncology R&D
Slide 15: Tagrisso and Imfinzi
Tagrisso and Imfinzi Increased reimbursement continuing to drive demand growth Tagrisso: 13% growth to $3.7bn Imfinzi: 17% growth to $1.8bn Approvals/Reimbursements: 64/13 (adjuvant), 91/47 (1L), 91/67 (2L) Approvals/Reimbursements: 74/35 (NSCLC), 63/9 (ES-SCLC) $m $m 1,400 • US +13% 700 • US +3% Cu
Slide 16: Lynparza
Lynparza The globally leading PARP inhibitor across four tumour types Product sales Growth in all regions Collaboration revenue1 31% growth to $1.7bn Approvals: 86 (OC), 84 (mBC), 70 (mCRPC) $3.1bn recorded, $4.6bn future potential $m $m 700 • US +26% 1,000 Ovarian and prostate see strong growth, wi
Slide 17: Calquence and Enhertu
Calquence and Enhertu Strong launch trajectories continue Calquence: 146% growth to $843m Enhertu: 134% growth to $147m Approvals/Reimbursements: 70/20 (CLL), 34/13 (MCL) Approvals/Reimbursements: 9/4 (BC), 4/2 (GC) $m $m 400 • Global $843m; US $752m 80 • Total revenue: Global $147m; US $120m 350 •
Slide 18: Oncology: R&D pipeline highlights
Oncology: R&D pipeline highlights Strong presence at ESMO and WCLC congresses US FDA Enhertu DESTINY-Breast03 Lynparza PROpel BTD received Superior efficacy versus TDM-1 Innovation in 1st-line prostate cancer • Unprecedented 2nd-line monotherapy data that rivals 1st-line current • Trial met primary
Slide 19: Oncology: R&D pipeline highlights
Oncology: R&D pipeline highlights Positive data in liver cancer and biliary tract cancer Imfinzi + treme HIMALAYA Imfinzi TOPAZ-1 1st-line liver cancer + chemo in 1st-line biliary tract cancer • Combination met primary endpoint of • Met primary endpoint of improved improved overall survival versus o
Slide 20: What's next in Oncology
What’s next in Oncology Solid pipeline moving forward What’s next What’s now Phase III new medicines datopotamab New camizestrant Selected Phase I/II new medicines deruxtecan Phase III multiple cancers ✓ breast cancer adavosertib ceralasertib monalizumab capivasertib (WEE1) (ATR) head & neck cancer
Slide 21: BioPharmaceuticals, Emerging Markets
4 BioPharmaceuticals, Emerging Markets Ruud Dobber EVP, BioPharmaceuticals Business Mene Pangalos EVP, BioPharmaceuticals R&D
Slide 22: BioPharmaceuticals: Cardiovascular, Renal and Metabolism
BioPharmaceuticals: Cardiovascular, Renal and Metabolism Total Revenue $6.0bn; growth +10% Farxiga: 51% growth to $2.1bn Lokelma Strong momentum continues, fastest growing SGLT2i globally Branded leadership extended in the US $m 100% 90% US branded K+ binder TRx share1 900 80% 70% 800 • US +31%, Eur
Slide 23: BioPharmaceuticals: Respiratory and Immunology
BioPharmaceuticals: Respiratory and Immunology Total Revenue $4.5bn; growth +12% Fasenra Breztri Symbicort Symbicort 32% growth to $901m COPD launch uptake; sales of $130m Resilient performance #1 ICS/LABA medicine $m $m Top 8 markets triple FDCs globally brand share (DOT)2 400 1,000 300 12% 800 600
Slide 24: Emerging Markets
Emerging Markets Total revenue $7.5bn, excluding COVID-19 vaccine revenue Emerging markets +10%1 Diversified growth across geographies $m China +8%; Ex-China EMs +14%1 Addressing global unmet medical need 3,500 3,000 • Oncology $2.4bn +4%: Tagrisso $1bn, up 1% due to March 2021 1st-line NRDL inclusi
Slide 25: Respiratory & Immunology: R&D pipeline highlights
Respiratory & Immunology: R&D pipeline highlights Potential to change standards of care Saphnelo PT027 Tezepelumab Systemic lupus erythematosus Asthma Asthma • Received US and Japan approval • Positive phase III results from both • Regulatory submission completed • AHEG scheduled ahead of EU MANDALA
Slide 26: Vaccines and immune therapies: R&D pipeline highlights
Vaccines and immune therapies: R&D pipeline highlights Scientific leadership across active and passive immunisation Vaxzevria AZD7442 Nirsevimab COVID-19 COVID-19 Respiratory syncytial virus >1.5bn doses • PROVENT trial (prophylaxis) - • MELODY trial - 74.5% reduction of released for global supply b
Slide 27: What's next in BioPharmaceuticals
What’s next in BioPharmaceuticals Expanding pipeline What’s next What’s now Selected Phase I/II new medicines Phase III new medicines tozorakimab (MEDI3506) tozorakimab (MEDI3506) AZD7442 PT027 (IL33) (IL33) COVID-19 asthma DKD asthma, COPD, AD, COVID-19 cotadutide AZD1402 Phase II nirsevimab tezepe
Slide 28: Rare Disease
5 Rare Disease Marc Dunoyer Chief Executive Officer, Alexion
Slide 29: Rare Disease
Rare Disease Accelerating AstraZeneca’s strategic and financial development Strong financial Leader in Diversified rare track record Complement disease pipeline Science • Pre-acquisition: ~$6bn in • Continued C5 inhibition • 11 molecules in over 20 annual revenues1 innovation with subcutaneous clini
Slide 30: Building scientific bridges across AstraZeneca and Alexion
Building scientific bridges across AstraZeneca and Alexion Immunology & Gene therapy & AI & Data analytics Complement Oligonucleotides Protein engineering DevOps excellence Precision medicine Chemistry & Patient centricity Talent programmes Manufacturing Exploring more opportunities to build two-way
Slide 31: Rare Disease
Rare Disease Q3 2021 Total Revenue $1.3bn Rare disease Multiple Phase III results $m Pro-forma global growth, Q3 2021 across both LCM and NMEs 900 +7% 800 • Positive Phase III results for Ultomiris in generalised 700 myasthenia gravis 600 • Phase III trial for Ultomiris in amyotrophic lateral sclero
Slide 32: Rare Disease
Rare Disease Q3 20211 performance highlights leading C5 franchise Soliris Ultomiris Strensiq PNH, aHUS, gMG, NMOSD PNH, aHUS HPP • Global $798m, (-2%) • Global $297m, (+31%) • Global $159m, (+8%) • US (+4%), • US (+25%), • US (+6%), EU (-3%), EU (+77%), EU (+5%), EM (-40%), EM (n/m), EM (+75%), ERoW
Slide 33: What's next in Rare Disease
What’s next in Rare Disease Advancing diversified pipeline What’s next What’s now Selected Phase I/II new medicines Phase III new medicines ALXN1840 CAEL-101 Wilson disease AL-amyloidosis acoramidis (ALXN2060) danicopan (ALXN2040) ATTR PNH w/EVH ALXN1720 ALXN1830 (3rd-generation C5) (anti-FcRn) gMG
Slide 34: Closing remarks and Q&A
6 Closing remarks and Q&A
Slide 35: Pipeline catalysts for 2021 - 2022
Pipeline catalysts for 2021 - 2022 Industry leading news flow Q4 2021 H1 2022 H2 2022 AZD7442 - COVID-19 prophylaxis (US) Brilique - stroke (THALES) (EU, CN) Tagrisso - EGFRm NSCLC (adjuvant) (JP) Regulatory Forxiga - chronic kidney disease (CN) Enhertu - gastric cancer (2L+, HER2+) (EU) decision Fa
Slide 36: Q&A speakers
Pascal Soriot Aradhana Sarin Q&A to enter Click Executive Director and Chief Executive Officer Executive Director and Chief Financial Officer title here Year-to-date and Q3 2021 Results Dave Fredrickson Susan Galbraith Speakers Executive Vice President, Oncology Business Executive Vice President, On
Slide 37: Appendix
A Appendix
Slide 38: Investor Relations
Chris Sheldon Josie Afolabi chris.sheldon@astrazeneca.com josie.afolabi@astrazeneca.com Tom Waldron Christer Gruvris Investor tom.waldron@astrazeneca.com christer.gruvris@astrazeneca.com Relations Morgan Sanford Philip Sparks morgan.sanford@astrazeneca.com philip.sparks1@astrazeneca.com Lauren Swale
Slide 39: Use of AstraZeneca slides from conference calls and webcasts
Use of AstraZeneca slides from conference calls and webcasts The AstraZeneca webcast, conference call and presentation slides (together the ‘AstraZeneca materials’) are for your personal, non-commercial use only. You may not copy, reproduce, republish, post, broadcast, transmit, make available to th