Astrazeneca Plc · LSE:AZN

Astrazeneca — FY2017 Earnings Presentation

112 slides from Astrazeneca's earnings presentation, 2018

1. Slide 1: Clinical trials appendix: Full-Year and Q4 2017 Results update

   Clinical trials appendix Full-Year and Q4 2017 Results update

2. Slide 2: About the clinical trials information

   The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from https://clinicaltrials.gov to facilitate understanding of key aspects of ongoing clinical programmes and is correct to the best of the Company’s knowledge as of 31 December 2017

3. Slide 3: List of abbreviations

   List of abbreviations AE Adverse Event LCM Lifecycle Management PD Pharmacodynamics AUC Area Under Curve LPCD Last Patient Commenced Dosing Q2W Quaque (every) Two Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q3W Quaque (every) Three Weeks CE Clinically Evaluable MDI Metered-Dos

4. Slide 4: Table of contents

   Table of contents slide Early development - IMED (AstraZeneca Research & Early Development) Movement since Q3 2017 results announcement Oncology Year-to-date and Q4 2017 New Molecular Entity (NME) pipeline CVMD Year-to-date and Q4 2017 Lifecycle Management (LCM) pipeline Respiratory Other Approved m

5. Slide 5: Movement since Q3 2017 update

   Movement since Q3 2017 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NMEs Life-cycle Management AZD1390 Imfinzi# + MEDI0457# tezepelumab NAVIGATOR SOURCE Tagrisso FLAURA [US]1 ATM inhibitor healthy volunteer study PD-L1 mAb + DNA HPV vaccine HNSCC TSLP mAb

6. Slide 6: Q4 2017 New Molecular Entity (NME) Pipeline

   Q4 2017 New Molecular Entity (NME)1 Pipeline 1 Includes significant fixed-dose combination projects, and parallel indications that are in a separate therapy area (See LCM chart for other parallel indications and oncology combination projects) # Partnered and/or in collaboration; ¶ Registrational P2/

7. Slide 7: Q4 2017 Lifecycle Management (LCM) Pipeline

   Q4 2017 Lifecycle Management (LCM)1 Pipeline 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study Oncology Cardiovascular and Metabolic Diseas

8. Slide 8: Q4 2017 Lifecycle Management (LCM) Pipeline

   Q4 2017 Lifecycle Management (LCM)1 Pipeline 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study Oncology Cardiovascular and Metabolic Diseas

9. Slide 9: Approved medicines

   AstraZeneca Approved medicines

10. Slide 10: Lynparza: ovarian cancer and other cancers

    Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other cancers Trial Population Patients Design Endpoints Status CVMD Phase III Platinum-sensitive recurrent 295 • Arm 1: Lynparza tablets 300mg BiD a

11. Slide 11: Lynparza: breast cancer and other cancers

    Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Breast cancer and other cancers Trial Population Patients Design Endpoints Status CVMD Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to

12. Slide 12: Tagrisso: non-small cell lung cancer

    Approved medicines Oncology Late-stage development Tagrisso (Highly-selective, irreversible EGFRi) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) CVMD Trial Population Patients Design Endpoints Status Phase III Advanced EGFRm NSCLC 410 • Arm 1: Tagrisso 80m

13. Slide 13: Tagrisso: non-small cell lung cancer

    Approved medicines Oncology Late-stage development Tagrisso (Highly-selective, irreversible EGFRi) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) CVMD Trial Population Patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC 308 • Arm 1: Tagrisso + Im

14. Slide 14: Imfinzi: non-small cell lung cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase III Adjuvant NSCLC patients 1,100 • Arm 1: Imfinzi mg/kg IV Q4W x 12m • Primar

15. Slide 15: Imfinzi: other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Other cancers CVMD Trial Population Patients Design Endpoints Status Phase I Solid tumours 108 • Dose Escalation: N=36, three cohorts receiving Treatment A • Safety and Toler

16. Slide 16: Imfinzi + tremelimumab: NSCLC and other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Non-small cell lung cancer (NSCLC) and other cancers CVMD Trial Population Patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC 480 •

17. Slide 17: Imfinzi + tremelimumab: other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Other cancers CVMD Trial Population Patients Design Endpoints Status Phase III Advanced Solid Malignancies 1,200 • Arm 1: Imfinzi • Primary endpoi

18. Slide 18: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase III Relapsed/refractory chronic 500 • Arm A: Calquence • Primary endpoint: P

19. Slide 19: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase I/II B-Cell Malignancies 126 Dose escalation and expansion trial of the comb

20. Slide 20: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase I Japanese Adults with 28 • Calquence monotherapy • Safety • FPCD: Q2 2017 A

21. Slide 21: Calquence: other cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Other cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 20

22. Slide 22: Brilinta: cardiovascular risk reduction

    Approved medicines Oncology Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular risk reduction Trial Population Patients Design Endpoints (primary) Status CVMD Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta

23. Slide 23: Farxiga: diabetes

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVMD Phase III/IV Type-2 diabetes 17,276 • Arm 1: Farxiga 10mg QD + SoC therapy QD • Primary endpoint: Time t

24. Slide 24: Farxiga: diabetes / cardiovascular risk reduction

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes / cardiovascular risk reduction Trial Population Patients Design Endpoints Status CVMD Phase III Patients With Chronic Heart 4,500 • Arm 1: Farxiga 10mg or 5 m

25. Slide 25: Qtern: type-2 diabetes

    Approved medicines Oncology Late-stage development Qtern (saxagliptin/dapagliflozin) (DPP-4/SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVMD Phase III Type-2 diabetes 420 • Arm 1: saxagliptin 5mg + dapaglif

26. Slide 26: Bydureon: type-2 diabetes

    Approved medicines Oncology Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVMD Phase IV Type-2 diabetes 14,742 • Arm 1: Bydureon once weekly 2mg SC • Primary endpoint:

27. Slide 27: Epanova: hypertriglyceridaemia

    Approved medicines Oncology Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial Population Patients Design Endpoints Status CVMD Phase III Patients with 13,000 • Arm 1: Epanova 4g QD + statin • Primary endpoint:

28. Slide 28: Symbicort: mild asthma

    Approved medicines Oncology Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Trial Population Patients Design Endpoints Status CVMD Phase III Patients in need of GINA 3,850 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as needed' + Placebo •

29. Slide 29: Eklira/Tudorza: COPD

    Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase IV Patients with COPD 224 • Arm 1: Eklira/Tudorza 400μg • Primary

30. Slide 30: Eklira/Tudorza: COPD

    Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial Population Number of patients Design Endpoints Status CVMD Phase I Healthy Chinese 18 Open-label, 2-period ascending dose

31. Slide 31: Duaklir Genuair: COPD

    Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase IIb Patients with moderate COPD 120 • Arm 1: Duaklir Genuair

32. Slide 32: Duaklir Genuair: COPD

    Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase IIa Chinese patients with stable 20 • Single and multiple tw

33. Slide 33: Bevespi Aerosphere: COPD

    Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to very severe 2,103 Treatment (24-week Trea

34. Slide 34: Bevespi Aerosphere: COPD

    Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status CVMD Phase III Moderat

35. Slide 35: Daliresp/Daxas: COPD

    Approved medicines Oncology Late-stage development Daliresp/Daxas (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 5

36. Slide 36: Fasenra: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Fasenra (benralizumab, IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Severe, uncontrolled asthma, 1,026 HD + ~200 MD • Arm 1: 30mg Q8w S

37. Slide 37: Fasenra: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Fasenra (benralizumab, IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Asthmatic with FEV1 (50-90% 200 • Arm 1: 30mg Q4W SC • Primary endp

38. Slide 38: Fasenra: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Fasenra (benralizumab, IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Severe asthma 230 • Arm 1: 30mg Q4W SC • Primary endpoint: Onset an

39. Slide 39: Fasenra: COPD

    Approved medicines Oncology Late-stage development Fasenra (benralizumab, IL-5R mAb) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to very severe 2,168 • Arm 1: 10mg Q8W SC

40. Slide 40: Calquence: rheumatoid arthritis

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib) Early development - IMED Early development - MedImmune Rheumatoid arthritis Trial Population Patients Design Endpoint(s) Status CVMD Phase II Rheumatoid Arthritis 31 • Arm A: Calquence + methotrexate Disease Activity Score

41. Slide 41: Late-stage pipeline

    AstraZeneca Late-stage pipeline

42. Slide 42: Moxetumomab pasudotox: blood cancer

    Approved medicines Oncology Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Blood cancer Trial Population Patients Design Endpoints Status CVMD Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial •

43. Slide 43: Selumetinib: thyroid cancer and other cancers

    Approved medicines Oncology Late-stage development Selumetinib (MEK-inhibitor) Early development - IMED Early development - MedImmune Thyroid cancer and other cancers Trial Population Patients Design Endpoints Status CVMD Phase III Differentiated thyroid cancer 304 • Arm 1: selumetinib 75mg BiD 5 we

44. Slide 44: Savolitinib: papillary renal cell and other cancers

    Approved medicines Oncology Late-stage development Savolitinib (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial Population Patients Design Endpoints Status CVMD Phase III MET-Driven, Papillary renal 180 • Arm 1: savolitinib 600mg QD • Primary

45. Slide 45: Cediranib: ovarian cancer

    Approved medicines Oncology Late-stage development Cediranib (VEGF-inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Trial Population Patients Design Endpoints Status CVMD Phase IIb Platinum resistant recurrent 100 • Cediranib 30 mg + Lynparza 200 mg bd • ORR DoR, DCR,

46. Slide 46: ZS-9: hyperkalaemia

    Approved medicines Oncology Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Phase II Population Hyperkalaemia and moderate chronic kidney disease (CKD) Patients 90 Design • Arm 1: Escalating TID doses (0.3g, 3g a

47. Slide 47: ZS-9: hyperkalaemia

    Approved medicines Oncology Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Population Patients Design Endpoints Status Phase I Healthy Subjects 22 Arm 1: Open-label ZS 5g QD for 4 days • Primary endpoint: Mean c

48. Slide 48: Roxadustat: anaemia

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVMD Phase III ANDES Anaemia in CKD patients not 900 • Arm 1: roxadustat Primary endpoint: Haemoglobin response • F

49. Slide 49: Roxadustat: anaemia

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVMD Phase III HIMALAYAS Anaemia in newly initiated 750 • Arm 1: roxadustat Primary endpoint: Haemoglobin response

50. Slide 50: PT010: COPD and asthma

    Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) & asthma Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to very severe 500 Treatments (52-week Treat

51. Slide 51: Tezepelumab: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Severe asthma 1,060 • Arm 1: tezepelumab SC • Primary endpoint: Annual asthma

52. Slide 52: Anifrolumab: lupus

    Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) / Lupus nephritis (LN) Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to severe SLE 450 • Arm

53. Slide 53: Lanabecestat: Alzheimer's disease

    Approved medicines Oncology Late-stage development Lanabecestat (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVMD Phase III Early Alzheimer’s disease 2,218 • Arm 1: lanabecestat 20mg once daily • Primary

54. Slide 54: Early development - IMED

    AstraZeneca Early development - IMED (AstraZeneca Research and Early Development)

55. Slide 55: AZD0156 (ATM): cancer

    Approved medicines Oncology Late-stage development AZD0156 (ATM) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, PK and efficacy • FPCD: Q4 2015 • Arm 2:

56. Slide 56: AZD1775 (WEE-1): cancer

    Approved medicines Oncology Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVMD Phase II Platinum-resistant (PR) 97 • Arm B: p

57. Slide 57: AZD1775 (WEE-1): cancer

    Approved medicines Oncology Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVMD Phase I Advanced solid tumours 24 Open-label,

58. Slide 58: Vistusertib (AZD2014): cancer

    Approved medicines Oncology Late-stage development Vistusertib (AZD2014) (TORC 1/2) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase II 2L oestrogen-receptor positive 316 • Arm 1: Faslodex • Primary endpoint: PFS • FPCD: Q2 20

59. Slide 59: AZD1390 (ATM BBB): cancer

    Approved medicines Oncology Late-stage development AZD1390 (ATM BBB) Early development - IMED Early development - MedImmune Cancer Trial Population Subjects Design Endpoints Status CVMD Phase I Healthy Volunteers 8 • Positron-Emission Tomography (PET) Study • Brain distribution of AZD1390 to assess

60. Slide 60: AZD2811 (AURN): cancer

    Approved medicines Oncology Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPCD: Q4 2015 • Arm 2: AZD2811

61. Slide 61: AZD4547 (FGFR): cancer

    Approved medicines Oncology Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase II Female ER+ breast cancer 40 • Part A: AZD4547 in ascending multiple doses in combination • Part A: MTD of AZ

62. Slide 62: AZD4573 (CDK9): cancer

    Approved medicines Oncology Late-stage development AZD4573 (CDK9) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Relapsed/refractory 42 Dose Escalation in relapsed/refractory haematological • Primary-Safety/PK; secondary-e

63. Slide 63: AZD4635 (A2AR): cancer

    Approved medicines Oncology Late-stage development AZD4635 (A2AR) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 36 (estimated) • Phase 1a: dose escalation to determine the Maximum Primary Outcome M

64. Slide 64: AZD4785 (KRAS antisense): cancer

    Approved medicines Oncology Late-stage development AZD4785 (KRAS antisense oligonucleotide) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 30 (estimated) • Phase Ia: dose escalation to determine the

65. Slide 65: AZD5069 (CXCR2): cancer

    Approved medicines Oncology Late-stage development AZD5069 (CXCR2) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 405 Dose Escalation advanced solid and blood cancers • Safety/Efficacy trial

66. Slide 66: AZD5153 (BRD4): cancer

    Approved medicines Oncology Late-stage development AZD5153 (BRD4) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I/Ib Relapsed/refractory solid 54 Dose Escalation advanced solid and lymphomas • Primary-Safety/ secondary-Effi

67. Slide 67: AZD5363 (AKT): cancer

    Approved medicines Oncology Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Breast and gynaecological 12-24 per arm (Parts E AZD5363 400mg BD 4 days on 3 days off combined with 500mg • S

68. Slide 68: AZD5991 (MCL1): cancer

    Approved medicines Oncology Late-stage development AZD5991 (MCL1) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Relapsed/refractory 30 Dose Escalation in relapsed/refractory haematological • Primary-Safety/ secondary-Effi

69. Slide 69: AZD6738 (ATR): cancer

    Approved medicines Oncology Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPCD: Q4 2014 • Arm 2: AZD6738 do

70. Slide 70: AZD8186 (PI3Kb/d): cancer

    Approved medicines Oncology Late-stage development AZD8186 (PI3Kb/d) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced Castrate Resistant 153 • Part A: AZD8186 monotherapy in ascending intermittent doses • Part A: PK

71. Slide 71: AZD9150 (STAT3): cancer

    Approved medicines Oncology Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 405 Dose Escalation advanced solid and blood cancers • Safety/Efficacy trial

72. Slide 72: AZD9496 (SERD): breast cancer

    Approved medicines Oncology Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Trial Population Patients Design Endpoints Status CVMD Phase I ER+ Breast Cancer ~50 • This is an open label randomised multicentre pre-surgical • Primary Outcome Me

73. Slide 73: AZD4831 & AZD5718: cardiovascular disease

    Approved medicines Oncology Late-stage development AZD4831 & AZD5718 Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD AZD4831 (MPO) Healthy subjects ~96 SAD trial (one trial site in Germany) • Safety and tolerability

74. Slide 74: AZD8601 (VEGF-A): cardiovascular disease

    Approved medicines Oncology Late-stage development AZD8601 (VEGF-A) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD Phase I Type 2 diabetic patients ~60 SAD trial (one trial site in Germany) • Safety and tolerabilit

75. Slide 75: Verinurad: chronic kidney disease

    Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development - IMED Early development - MedImmune Chronic kidney disease Trial Population Patients Design Endpoints Status CVMD Phase II CKD patients with 60 • Arm A: verinurad 9 mg and febuxostat 80 mg To

76. Slide 76: Abediterol: asthma

    Approved medicines Oncology Late-stage development Abediterol (AZD0548, LABA) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase I Patients With Asthma on 12 A randomised, single-blind, placebo-controlled study to assess • To as

77. Slide 77: AZD1419 (TLR9 agonist): asthma

    Approved medicines Oncology Late-stage development AZD1419 (TLR9 agonist) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase IIa Adults with eosinophilic, 81 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to los

78. Slide 78: AZD5634: cystic fibrosis

    Approved medicines Oncology Late-stage development AZD5634 (epithelial NaC inhibitor) Early development - IMED Early development - MedImmune Cystic fibrosis Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects Part A: 57 SAD. Primary Endpoint • FPCD: Q1 2016 Part B: 6 A Ph

79. Slide 79: AZD7594 (inhaled SGRM): asthma/COPD

    Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase II Patients with mild to moderate 48 A randomised, double

80. Slide 80: AZD7594 (inhaled SGRM): asthma/COPD

    Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 18 A randomised open label three-way cr

81. Slide 81: AZD8871 (MABA2): COPD

    Approved medicines Oncology Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase IIa Moderate to severe COPD 42 Comprises 3 treatment periods of 14 days

82. Slide 82: AZD9567 (oSGRM): respiratory

    Approved medicines Oncology Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Respiratory Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 71 MAD trial with a total of 6 dose levels of AZD9567: 10 mg, 20mg, Primary Endpoint:

83. Slide 83: AZD0284 (RORγ): plaque psoriasis

    Approved medicines Oncology Late-stage development AZD0284 (RORγ) Early development - IMED Early development - MedImmune Plaque psoriasis vulgaris Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 80 Part 1 (SAD) • Safety and tolerability and PK following • FPCD: Q3 201

84. Slide 84: Early development - MedImmune

    MedImmune Early development - MedImmune Research & Early Development

85. Slide 85: Imfinzi (PD-L1 mAb): cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Cancer Trial Compound Population Patients Design Endpoints Status CVMD Phase I/II Imfinzi Solid tumours 1,022 • Dose Escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Safety

86. Slide 86: Imfinzi + tremelimumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase Ib/II Gastric or GEJ 236 • Arm A: Imfinzi + tremelimumab 2L • Primary endpoint

87. Slide 87: Imfinzi + Iressa: NSCLC

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) CVMD Trial Population Patients Design Endpoints Status Phase I NSCLC 56 Escalation phase Primary endpoints: • FPCD: Q2

88. Slide 88: Imfinzi + MEDI0680: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + MEDI0680 (PD-1 mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 96 Dose-escalation phase Primary endpoints: • FPCD: Q2 2014

89. Slide 89: Imfinzi + dabrafenib/trametinib: melanoma

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + dabrafenib Early development - IMED Early development - MedImmune (BRAF inhibitor) / trametinib (MEK inhibitor) Melanoma CVMD Trial Population Patients Design Endpoints Status Phase I/II Metastatic or unresectable 68 Dose Escal

90. Slide 90: Imfinzi + monalizumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + monalizumab (NKG2a mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 175 Escalation phase Primary endpoints: • FPCD: Q2 2016

91. Slide 91: MEDI0457 + Imfinzi: SCCHN

    Approved medicines Oncology Late-stage development MEDI0457 Early development - IMED Early development - MedImmune + Imfinzi (PD-L1 mAb) Squamous cell carcinoma of the Head and Neck (SCCHN) CVMD Trial Population Patients Design Endpoints Status Phase Ib/IIa Human papillomavirus (HPV) 50 Multi-centre

92. Slide 92: MEDI0562 (OX40 mAb): cancer

    Approved medicines Oncology Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + Imfinzi (PD-L1 mAb) or tremelimumab (CTLA-4 mAb) CVMD Cancer Trial Population Patients Design Endpoints Status Respiratory Phase I Advanced malignancies

93. Slide 93: MEDI1873 (GITR agonist): cancer

    Approved medicines Oncology Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Adult subjects with select 51 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 advanced soli

94. Slide 94: MEDI4276 (HER2 ADC mAb): cancer

    Approved medicines Oncology Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced HER2+ metastatic Dose escalation • First-time-in-human Phase 1, multi-centre, open-label, s

95. Slide 95: MEDI5083 + Imfinzi: cancer

    Approved medicines Oncology Late-stage development MEDI5083 + Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced Solid Tumours 204 Dose-escalation phase Primary endpoints: • FPCD: Q1 2017 • Part 1:

96. Slide 96: MEDI7247 (PBD ADC mAb): cancer

    Approved medicines Oncology Late-stage development MEDI7247 (PBD ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Relapsed/Refractory 228 First-time-in-human Phase 1, multi-centre, open-label, single-arm, • Primary

97. Slide 97: MEDI9197 (TLR7/8 agonist): cancer

    Approved medicines Oncology Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced solid tumour 135 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 malignancies re

98. Slide 98: MEDI9447 (CD73 mAb) + Imfinzi: cancer

    Approved medicines Oncology Late-stage development MEDI9447 (CD73 mAb) Early development - IMED Early development - MedImmune + Imfinzi (PD-L1 mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase Primary endpoints: • FPCD: Q3 2015

99. Slide 99: Other biologics: cancer

    Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Cancer Trial Compound Population Patients Design Endpoints Status CVMD Phase I Anti-CEA BiTE mAb Adults with 51 max • Dose-escalation (3+3), IV • MTD and safety profile • FPCD: Q

100. Slide 100: MEDI0382 (GLP-1-glucagon): diabetes

     Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVMD Phase I Healthy adult subjects 64 • SAD SC administration • Safety profile in terms of adverse events (A

101. Slide 101: MEDI0382 (GLP-1-glucagon): diabetes

     Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVMD Phase I Healthy adult subjects 22 • Open label, one sequence, cross-over • Effect of MEDI0382 on PK & PD

102. Slide 102: Biologics: cardiovascular & metabolic diseases

     Approved medicines Oncology Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic diseases Trial Compound Population Patients Design Endpoints Status CVMD Phase IIa rhLCAT Adults with stable 56 • SAD in stable CAD patients • Safety profile

103. Slide 103: MEDI3506 (IL-33 mAb): COPD

     Approved medicines Oncology Late-stage development MEDI3506 (IL-33 mAb) Early development - IMED Early development - MedImmune COPD Trial Population Patients Design Endpoints Status CVMD Phase I (Combined SAD / SAD: Healthy subjects with SAD: 56 SAD: • Safety and tolerability • FPCD: Q2 2017 MAD) mi

104. Slide 104: MEDI7836 (IL-13 mAb): asthma

     Approved medicines Oncology Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 32 • Arm 1: 30mg MEDI7836 (6) or placebo (2) as a single • Safety and tolerability • F

105. Slide 105: MEDI0700 - AMG: SLE

     Approved medicines Oncology Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVMD Phase Ia Healthy subjects 48 Single Ascending Dose • Safety an

106. Slide 106: MEDI1814 (amyloid beta mAb): Alzheimer's disease

     Approved medicines Oncology Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVMD Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPCD: Q2 201

107. Slide 107: MEDI5872 - AMG (B7RP-1 mAb): SLE

     Approved medicines Oncology Late-stage development MEDI5872 - AMG 557 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVMD Phase IIa Primary Sjögren's syndrome 42 • Arm 1: MEDI5872 210mg SC QW fo

108. Slide 108: MEDI7352 (NGF TNF Bispecific): osteoarthritis pain

     Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF Bispecific) Early development - IMED Early development - MedImmune Osteoarthritis pain Trial Population Patients Design Endpoints Status CVMD Phase I Painful osteoarthritis of the knee 160 • SAD & MAD • Safety, tolerability, PK, PD

109. Slide 109: MEDI9314 (IL-4Ra mAb): atopic dermatitis

     Approved medicines Oncology Late-stage development MEDI9314 (IL-4Ra mAb) Early development - IMED Early development - MedImmune Atopic dermatitis Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 44 • Arm 1: 45mg MEDI9314 (4) or placebo (2) as a single SC dose • Safety

110. Slide 110: Other biologics: autoimmunity

     Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Trial Compound Population Patients Design Endpoints Status CVMD Phase II/III Inebilizumab Adults with 212 (estimated) • Arm 1: inebilizumab 500mg IV • Primary: Time

111. Slide 111: Other biologics: infections

     Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Trial Compound Population Patients Design Endpoints Status CVMD Phase II Anti-Staph AT Intubated ICU 285 • Placebo-controlled, single-dose, dose-ranging • Efficacy and

112. Slide 112: Clinical trials appendix: Full-Year and Q4 2017 Results update

     Clinical trials appendix Full-Year and Q4 2017 Results update

AstraZeneca — FY2017 Earnings Presentation on 6ix