Astrazeneca Plc · LSE:AZN

Astrazeneca — FY2016 Earnings Presentation

104 slides from Astrazeneca's earnings presentation, 2017

1. Slide 1: Clinical trials appendix: Full-Year and Q4 2016 Results update

   Clinical trials appendix Full-Year and Q4 2016 Results update

2. Slide 2: About the clinical trial 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 201

3. Slide 3: List of abbreviations

   List of abbreviations AE Adverse Event LCM Life-Cycle Management Q2W Quaque (every) Two Weeks AUC Area Under Curve LPCD Last Patient Commenced Dosing Q3W Quaque (every) Three Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q4W Quaque (every) Four Weeks CE Clinically Evaluable MDI

4. Slide 4: Table of contents

   Table of contents slide Early development - IMED Movement since Q3 2016 update Oncology Q4 2016 New Molecular Entity (NME) Pipeline CVMD Q4 2016 Lifecycle Management (LCM) Pipeline Respiratory Other Approved medicines Oncology CVMD Early development - MedImmune Respiratory Oncology CVMD Respiratory

5. Slide 5: Movement since Q3 2016 update

   Movement since Q3 2016 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NME’s AZD0284 AZD1419# benralizumab# [EU & US]1 Inhaled RORg psorisis TLR9 asthma IL-5R severe asthma AZD7594+abediterol# AZD1775# Inhaled SGRM+LABA asthma/COPD Wee1 solid tumours Addition

6. Slide 6: Q4 2016 New Molecular Entity (NME) Pipeline

   Q4 2016 New Molecular Entity (NME)1 Pipeline Oncology Cardiovascular and metabolic disease Respiratory Other 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 pro

7. Slide 7: Q4 2016 Lifecycle Management (LCM) Pipeline

   Q4 2016 Lifecycle Management (LCM)1 Pipeline Oncology Cardiovascular and metabolic disease Respiratory Other 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; ¶ Regist

8. Slide 8: Approved medicines

   AstraZeneca Approved medicines

9. Slide 9: Lynparza (PARP inhibitor) ovarian cancer

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

10. Slide 10: Lynparza (PARP inhibitor) solid tumours

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

11. Slide 11: Tagrisso (EGFR TKI) NSCLC

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

12. Slide 12: Tagrisso (EGFR TKI) NSCLC

    Approved medicines Oncology Late-stage development Tagrisso Early development - IMED Early development - MedImmune (Highly-selective, irreversible EGFR TKI) Non-small cell lung cancer (NSCLC) CVMD Trial Population Patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC TKI ~90 • Arm 1: Tagris

13. Slide 13: Brilinta (ADP receptor antagonist)

    Approved medicines Oncology Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Trial Population Patients Design Endpoints (primary) Status CVMD Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta 60mg BiD • Com

14. Slide 14: Farxiga (SGLT2 inhibitor)

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVMD Phase IV Japanese patients with type-2 266 • Arm 1: Farxiga 5mg • Change from baseline in Haemogl

15. Slide 15: Onglyza (DPP-4 inhibitor)

    Approved medicines Oncology Late-stage development Onglyza (DPP-4 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVMD Phase III Type-2 diabetes 444 • Arm 1: Onglyza 5mg QD + insulin with or without metformin Primary

16. Slide 16: Qtern (saxagliptin/dapagliflozin)

    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

17. Slide 17: Bydureon (GLP-1 receptor agonist)

    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 14,743 • Arm 1: Bydureon once weekly 2mg SC • Time to first conf

18. Slide 18: Epanova (omega-3 carboxylic acids)

    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 Japanese patients with 375 • Epanova 2g and 4g vs. Placebo (after meal)

19. Slide 19: Epanova (omega-3 carboxylic acids)

    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 I Healthy subjects 40 Part A • Arm 1: D1400147 4g • Rate and extent of absor

20. Slide 20: Symbicort (ICS/LABA)

    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 •

21. Slide 21: Eklira/Tudorza (LAMA)

    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: Aclidinium bromide 400μg • Chan

22. Slide 22: Duaklir (LAMA/LABA)

    Approved medicines Oncology Late-stage development Duaklir (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: Aclidinium/formoterol F

23. Slide 23: Duaklir (LAMA/LABA)

    Approved medicines Oncology Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase IV Patients with moderate COPD 268 • Arm 1: Aclidinium/formoterol FD

24. Slide 24: Bevespi Aerosphere (LAMA/LABA)

    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

25. Slide 25: Bevespi Aerosphere (LAMA/LABA)

    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 IIIb Moderate to severe COPD 150 Treatment (5- to 6- week

26. Slide 26: Bevespi Aerosphere (LAMA/LABA)

    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

27. Slide 27: Daliresp/Daxas (oral PDE4 inhibitor)

    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

28. Slide 28: Late-stage pipeline

    AstraZeneca Late-stage pipeline

29. Slide 29: Durvalumab (PD-L1 mAb) NSCLC

    Approved medicines Oncology Late-stage development Durvalumab (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: Durvalumab mg/kg IV Q4W x 12m •

30. Slide 30: Durvalumab (PD-L1 mAb) HNSCC and other solid tumours

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune Squamous Cell Carcinoma of the Head & Neck (HNSCC) and other solid tumours CVMD Trial Population Patients Design Endpoints Status Phase I Solid tumours 108 • Dose Escalati

31. Slide 31: Durvalumab + tremelimumab solid tumours

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours CVMD Trial Population Patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC 480 • Arm 1: durvalumab + tremelimumab (P

32. Slide 32: Durvalumab + tremelimumab solid tumours

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours CVMD Trial Population Patients Design Endpoints Status Phase II Urothelial Bladder Cancer 76 • Arm 1 Tremelimumab in Urothelial B

33. Slide 33: Acalabrutinib (BTK inhibitor) blood cancers

    Approved medicines Oncology Late-stage development 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: acalabrutinib • PFS • FPD: Q4 2015 ACE-CL-

34. Slide 34: Acalabrutinib (BTK inhibitor) blood cancers

    Approved medicines Oncology Late-stage development 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 combination of

35. Slide 35: Acalabrutinib (BTK inhibitor) solid tumours

    Approved medicines Oncology Late-stage development Acalabrutinib (BTK inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoint(s) Status CVMD Phase II ≥ 2L advanced or metastatic 78 • Arm A: pembrolizumab • ORR • FPD: Q2 2015 ACE-ST-00

36. Slide 36: Moxetumomab pasudotox (CD22 mAb)

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

37. Slide 37: Selumetinib (MEK-inhibitor)

    Approved medicines Oncology Late-stage development Selumetinib (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase III Differentiated thyroid cancer 304 • Arm 1: Selumetinib 75mg BiD 5 weeks duration + RAI

38. Slide 38: Roxadustat (HIF-PHI) CKD/ESRD

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease (CKD/ESRD) CVMD Trial Population Patients Design Endpoints Status Phase III ANDES Anaemia in CKD patients not 600 • Arm 1: Rox

39. Slide 39: Roxadustat (HIF-PHI) CKD/ESRD

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease (CKD/ESRD) CVMD Trial Population Patients Design Endpoints Status Phase III HIMALAYAS Anaemia in newly initiated 1,000 • Arm 1

40. Slide 40: ZS-9 (Sodium zirconium cyclosilicate)

    Approved medicines Oncology Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalemia Trial Population Patients Design Endpoints Status CVMD Phase II Hyperkalemia and moderate 90 • Arm 1: Escalating TID doses (0.3g, 3g and 10g) o

41. Slide 41: Benralizumab (IL-5R mAb) severe asthma

    Approved medicines Oncology Late-stage development 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 SC • Annua

42. Slide 42: Benralizumab (IL-5R mAb) severe asthma

    Approved medicines Oncology Late-stage development 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 • Pulmonary function (F

43. Slide 43: Benralizumab (IL-5R mAb) severe asthma

    Approved medicines Oncology Late-stage development 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 • Onset and maintenance of effect on

44. Slide 44: Benralizumab (IL-5R mAb) COPD

    Approved medicines Oncology Late-stage development 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 • Rate o

45. Slide 45: Tralokinumab (IL-13 mAb) severe asthma

    Approved medicines Oncology Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Adults with severe, 1,140 Cohort 1: Primary: • FPD: Q3 2014 STRATOS 1 uncont

46. Slide 46: PT010 (LAMA/LABA/ICS) COPD & 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

47. Slide 47: PT010 (LAMA/LABA/ICS) COPD & 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 II Adult mild to moderate 150 • Arm 1: BD MDI 320μg BiD •

48. Slide 48: PT010 (LAMA/LABA/ICS) COPD & 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 I Healthy subjects 60 • Arm 1: BGF MDI 320/14.4/9.6μg • O

49. Slide 49: Anifrolumab (type I IFN receptor mAb) SLE

    Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to severe SLE 450 • Arm 1: 300mg IV MEDI-546 Q4

50. Slide 50: Anifrolumab (type I IFN receptor mAb) Lupus Nephritis

    Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Lupus Nephritis (LN) Trial Population Patients Design Endpoints Status CVMD Phase II Active Proliferative LN (TULIP- 150 • Arm 1: 900 mg IV Q4W for 12 weeks

51. Slide 51: AZD3293 (BACE inhibitor) Alzheimer's disease

    Approved medicines Oncology Late-stage development AZD3293 (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVMD Phase III Early Alzheimer’s disease 2,202 • Arm 1: AZD3293 20mg once daily • Changes in cognit

52. Slide 52: Acalabrutinib (ACP-196) Rheumatoid Arthritis

    Approved medicines Oncology Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Trial Population Patients Design Endpoint(s) Status CVMD Phase II Rheumatoid Arthritis 31 • Arm A: Acalabrutinib + methotrexate Disease Activity Scor

53. Slide 53: Early development - IMED

    AstraZeneca Early development - IMED

54. Slide 54: AZD0156 (ATM) solid tumours

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

55. Slide 55: AZD1775 (WEE-1)

    Approved medicines Oncology Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, Non-Small Cell Lung Cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase II p53 mutant PSR ovarian 136 • Arm

56. Slide 56: Vistusertib (AZD2014) (TORC 1/2)

    Approved medicines Oncology Late-stage development Vistusertib (AZD2014) (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous Non-Small Cell Lung Cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase II 2L ER+ metastatic breast 316 • Arm 1: Fasl

57. Slide 57: AZD2811 (AURN) solid tumours

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

58. Slide 58: AZD4547 (FGFR) solid tumours

    Approved medicines Oncology Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours 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: MT

59. Slide 59: AZD4635 (A2AR)

    Approved medicines Oncology Late-stage development AZD4635 (A2AR) Early development - IMED Early development - MedImmune Solid tumours and Non-Small Cell Lung Cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 36 (estimated) • Phase 1a: dose escalat

60. Slide 60: AZD5069 (CXCR2) solid tumours

    Approved medicines Oncology Late-stage development AZD5069 (CXCR2) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 213 Dose Escalation advanced solid and blood cancers • Safety/Efficacy

61. Slide 61: AZD5363 (AKT) solid tumours

    Approved medicines Oncology Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase IIb ER+ breast cancer receiving 100 • Arm 1: AZD5363 + paclitaxel • PFS • FPD: Q1 2014 st 1 treatment wit

62. Slide 62: Savolitinib (AZD6094) (MET)

    Approved medicines Oncology Late-stage development Savolitinib (AZD6094) (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial Population Patients Design Endpoints Status CVMD Phase II Papillary renal cell cancer 90 • Single arm trial: savolitinib

63. Slide 63: AZD6738 (ATR) solid tumours

    Approved medicines Oncology Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPD: Q4 2014 • Arm 2: AZD6

64. Slide 64: AZD8186 (PI3Kb/d) solid tumours

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

65. Slide 65: AZD9150 (STAT3)

    Approved medicines Oncology Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Solid tumours and blood cancers Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 213 Dose Escalation advanced solid and blood cancers

66. Slide 66: 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 a Phase I open label multicentre trial of AZD9496 • Primary Outcome Me

67. Slide 67: AZD4076 (anti-miR 103/107) NASH

    Approved medicines Oncology Late-stage development AZD4076 (anti-miR 103/107) Early development - IMED Early development - MedImmune Non-alcoholic steatohepatitis (NASH) Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 40 SAD trial (one trial site in US) • Safety and t

68. Slide 68: AZD4831 cardiovascular disease

    Approved medicines Oncology Late-stage development AZD4831 Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects ~96 SMAD trial (one trial site in Germany) • Safety and tolerability • FPD: Q3 2016

69. Slide 69: AZD5718 cardiovascular disease

    Approved medicines Oncology Late-stage development AZD5718 Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 96 SMAD trial (one trial site in UK) • Safety and tolerability • FPD: Q1 2016 SAD •

70. Slide 70: AZD8601 cardiovascular disease

    Approved medicines Oncology Late-stage development AZD8601 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 tolerability • FPD:

71. Slide 71: Abediterol (AZD0548) (LABA) 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 II Patients With Asthma on 36 Single-dose 6-way crossover to investigate ultra-low doses of Primar

72. Slide 72: 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, 70 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to los

73. Slide 73: AZD7594 (inhaled SGRM)

    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

74. Slide 74: AZD7986 (DPP1 inhibitor) COPD

    Approved medicines Oncology Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 152 Part 1 (SAD) • Safety and tolerability a

75. Slide 75: 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 I Part 1: Mild Asthmatic N (Part 1) = 16 Part 1 • To assess the safety a

76. Slide 76: AZD9567 (oSGRM)

    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 72 SAD trial with 8 dose levels - single ascending doses • A Phase I, Randomised, Sing

77. Slide 77: Verinurad (RDEA3170, URAT1 inhibitor)

    Approved medicines Oncology Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Trial Population Patients Design Endpoints Status CVMD Phase II Combination therapy trial with 60 • Arm

78. Slide 78: AZD3241 (MPO) Multiple System Atrophy

    Approved medicines Oncology Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Multiple System Atrophy (MSA) Trial Population Patients Design Endpoints Status CVMD Phase II Parkinson’s disease patients 24 • Arm 1: AZD3241 600mg BID for 8 weeks • Microglia act

79. Slide 79: Early development - MedImmune

    MedImmune Early development - MedImmune

80. Slide 80: Durvalumab (PD-L1 mAb) immuno-oncology

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune Immuno-oncology Trial Compound Population Patients Design Endpoints Status CVMD Phase I/II Durvalumab Solid tumours 1,014 • Dose Escalation: 5 cohorts at Q2W and 1 cohort

81. Slide 81: Durvalumab + tremelimumab solid and hematologic tumours

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid and hematologic tumours CVMD Trial Population Patients Design Endpoints Status Phase Ib/II Gastric or GEJ 236 • Arm A: durvalumab + treme

82. Slide 82: Durvalumab + Iressa (gefitinib) NSCLC

    Approved medicines Oncology Late-stage development Durvalumab (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 36 Escalation phase • Safety • FPD: Q2 2014 (E

83. Slide 83: Durvalumab + MEDI0680 (PD-1 mAb)

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) + MEDI0680 (PD-1 mAb) Early development - IMED Early development - MedImmune Advanced cancers Trial Population Patients Design Endpoints Status CVMD Phase I Advanced malignancies 150 Dose-escalation phase • Safety • FPD: Q2 20

84. Slide 84: Durvalumab + dabrafenib / trametinib melanoma

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) + dabrafenib (BRAF inhibitor) Early development - IMED Early development - MedImmune / trametinib (MEK inhibitor) Melanoma CVMD Trial Population Patients Design Endpoints Status Phase I/II Metastatic or unresectable 69 Dose Es

85. Slide 85: Durvalumab + Monalizumab (NKG2a mAb)

    Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune + Monalizumab (NKG2a mAb) Advanced Solid Tumours CVMD Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 175 Escalation phase • Safety • FPD:

86. Slide 86: MEDI0562 (OX40 mAb) advanced cancers

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

87. Slide 87: Inebilizumab (MEDI-551, CD19 mAb)

    Approved medicines Oncology Late-stage development Inebilizumab (MEDI-551, CD19 mAb) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoints Status CVMD Phase II Adults with relapsed or 170 • Arm 1: MEDI-551 dose level 1 and ICE/DHAP • ORR, inc

88. Slide 88: MEDI1873 (GITR agonist) solid tumours

    Approved medicines Oncology Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase I Adult subjects with select 42 Dose-escalation phase • Safety • FPD: Q4 2015 advanced solid tu

89. Slide 89: MEDI4276 (HER2 ADC mAb)

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

90. Slide 90: MEDI9197 (TLR7/8 agonist)

    Approved medicines Oncology Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase I Advanced solid tumour 43 Dose-escalation phase • Safety • FPD: Q4 2015 malignancies readily

91. Slide 91: MEDI9447 (CD73 mAb) + durvalumab

    Approved medicines Oncology Late-stage development MEDI9447 (CD73 mAb) + durvalumab Early development - IMED Early development - MedImmune (PD-L1 mAb) Advanced cancers CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase • Safety • FPD: Q3 20

92. Slide 92: Other biologics solid tumours

    Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Trial Compound Population Patients Design Endpoints Status CVMD Phase I/II Anti-IGF ligand mAb Patients with HR+ 176 • Arm 1: MEDI-573 IV and Aromatase Inhibitor •

93. Slide 93: Biologics cardiovascular & metabolic disease

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

94. Slide 94: Tezepelumab (MEDI9929, TSLP mAb) asthma

    Approved medicines Oncology Late-stage development Tezepelumab (MEDI9929, TSLP mAb) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase II Adult subjects with 552 • Arm 1: Placebo • Reduction in the annualised asthma • FPD: Q2 20

95. Slide 95: 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

96. Slide 96: MEDI0700 - AMG (Anti-B7RP-1 mAb/BAFF) 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 40 Single Ascending Dose • Safety an

97. Slide 97: 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 • FPD: Q2 2014

98. Slide 98: 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

99. Slide 99: MEDI7352 (NGF TNF Bispecific) osteoarthritis pain

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100. Slide 100: MEDI9314 (IL-4Ra mAb) atopic dermatitis

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101. Slide 101: Other biologics autoimmunity

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102. Slide 102: 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 462 • Placebo-controlled, single-dose, dose-ranging • Efficacy and

103. Slide 103: 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 Ib/IIa Anti-influenza A Adults 160 • Randomised, partial double-blind, single dose, • Evaluate sa

104. Slide 104: Clinical trials appendix: Full-Year and Q4 2016 Results update

     Clinical trials appendix Full-Year and Q4 2016 Results update

AstraZeneca — FY2016 Earnings Presentation on 6ix