Astrazeneca Plc · LSE:AZN

Astrazeneca — Q1 2016 Earnings Presentation

112 slides from Astrazeneca's earnings presentation, 2016

1. Slide 1: Clinical trials appendix Q1 2016 update

   Clinical trials appendix Q1 2016 update

2. Slide 2: Clinical trials information notice

   The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from 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 March 2016, unless ot

3. Slide 3: List of abbreviations

   List of abbreviations AEs Adverse Events LCM Lifecycle Management Q3W Every Three Weeks ASA Acetylsalicylic Acid LPCD Last Patient Commenced Dosing Q4W Every Four Weeks BiD Twice Daily MAD Multiple Ascending Dose trial Q8W Every Eight Weeks CE Clinically Evaluable MDI Metered Dose Inhaler QD Once Da

4. Slide 4: Movement since Q4 2015

   Movement since Q4 2015 New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NMEs AZD5634 MEDI3902¶ AZD3293# BACE Alz inhaled ENaC cystic fibrosis Psl/PcrV pseudomonas Beta secretase inhibitor Alzheimer’s disease MEDI9314 MEDI4166 IL4R atopic dermatitis PCSK9/GLP-1 diabet

5. Slide 5: Q1 2016 New Molecular Entity (NME) Pipeline

   Q1 2016 New Molecular Entity (NME)1 Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal 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 project

6. Slide 6: Q1 2016 Lifecycle Management (LCM) Pipeline

   Q1 2016 Lifecycle Management (LCM)1 Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # In collaboration; ¶ Registrational P2/3 study;

7. Slide 7: Lifecycle management (new uses of existing medicines)

   AstraZeneca Lifecycle management (new uses of existing medicines)

8. Slide 8: Symbicort (ICS/LABA) Mild asthma

   Lifecycle management Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Patients in need of GINA N = 3,750 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as need

9. Slide 9: Eklira/Tudorza (LAMA) COPD

   Lifecycle management Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IV Patients with COPD N = 224 • Arm 1: Aclidinium brom

10. Slide 10: Duaklir (LAMA/LABA) COPD

    Lifecycle management Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IV Patients with moderate to N = 268 • Arm 1: Aclidinium

11. Slide 11: Daliresp (oral PDE4 inhibitor) COPD

    Lifecycle management Late-stage development Daliresp (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IV COPD N = 2,354 • 52W, randomised, DB with

12. Slide 12: Zurampic (lesinurad) Gout

    Lifecycle management Late-stage development Zurampic (lesinurad) (SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout Trial phase Patient population Number of patients Design Endpoints Status Phase III Gout previously enrolled in N = 717 • Zurampic 200 or 400 mg QD • A

13. Slide 13: Lesinurad/allopurinol FDC Gout

    Lifecycle management Late-stage development Lesinurad/allopurinol FDC Early development - IMED Early development - MedImmune (SURI, URAT1 inhibitor/XOI inhibitor) Gout Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy Male Subjects N = 124 Cohort 1: cross-over

14. Slide 14: Bevespi Aerosphere (PT003) COPD

    Lifecycle management Late-stage development Bevespi Aerosphere (PT003, LABA/LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 2,103

15. Slide 15: Bevespi Aerosphere (PT003) COPD

    Lifecycle management Late-stage development Bevespi Aerosphere (PT003, LABA/LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IIIb Moderate to severe COPD N = 150 T

16. Slide 16: Bevespi Aerosphere (PT003) COPD

    Lifecycle management Late-stage development Bevespi Aerosphere (PT003, LABA/LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Statu

17. Slide 17: Brilinta/Brilique Cardiovascular

    Lifecycle management Late-stage development Brilinta/Brilique (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Trial phase Patient population Number of patients Design Endpoints Status Phase III Patients with prior MI N = 21,000 • Arm 1: Brilinta/Briliq

18. Slide 18: Brilinta/Brilique Cardiovascular

    Lifecycle management Late-stage development Brilinta/Brilique (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Trial phase Patient population Number of patients Design Endpoints Status Phase III (BE) Caucasian healthy volunteers N = 36 Single dose, Cros

19. Slide 19: Onglyza Type-2 Diabetes

    Lifecycle management Late-stage development Onglyza (DPP-4 inhibitor) Early development - IMED Early development - MedImmune Type-2 Diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase III Type-2 diabetes mellitus N = 444 • Arm 1: Onglyza 5 mg QD +insulin or Ongly

20. Slide 20: Farxiga/Forxiga Diabetes

    Lifecycle management Late-stage development Farxiga/Forxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase IV Japanese patients with type-2 N = 266 • Arm 1: Forxiga 5mg • Change from ba

21. Slide 21: Saxagliptin/dapagliflozin Diabetes

    Lifecycle management Late-stage development Saxagliptin/dapagliflozin (DPP-4/SGLT2 inhibitors) Early development - IMED Early development - MedImmune Diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase III Type-2 diabetes mellitus N = 420 • Arm 1: Saxagliptin 5 m

22. Slide 22: Bydureon Type-2 Diabetes

    Lifecycle management Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 Diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase IV Type-2 diabetes N = 14,000 • Arm 1: Bydureon once weekly 2mg SC • Ti

23. Slide 23: Bydureon Type-2 Diabetes

    Lifecycle management Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 Diabetes Trial phase Patient population Number of patients Design Endpoints Status Phase III Type-2 diabetes N = 660 • Arm 1: Bydureon once weekly 2 mg SC • Cha

24. Slide 24: Epanova Hypertriglyceridaemia

    Lifecycle management Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial phase Patient population Number of patients Design Endpoints Status Phase III Japanese patients with N = 375 • Epanova 2 g and 4 g vs. Pla

25. Slide 25: Epanova Hypertriglyceridaemia

    Lifecycle management Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 40 Part A • Arm 1: D1400147 4g • Rate a

26. Slide 26: Faslodex Breast cancer - metastatic

    Lifecycle management Late-stage development Faslodex (oestrogen receptor antagonist) Early development - IMED Early development - MedImmune Breast cancer - metastatic Trial phase Patient population Number of patients Design Endpoints Status Phase III Postmenopausal women with N ~ 450 • Arm 1: Faslod

27. Slide 27: Lynparza Ovarian cancer and other solid tumours

    Lifecycle management Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III PSR BRCAm ovarian cancer N = 264 • Arm 1: Lynparza t

28. Slide 28: Lynparza Solid tumours

    Lifecycle management Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III BRCAm metastatic breast N = 310 • Arm 1: Lynparza 300 mg BiD, continuous to p

29. Slide 29: Tagrisso NSCLC

    Lifecycle management Late-stage development Tagrisso (Highly selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase III Advanced EGFRm NSCLC N = 410 •

30. Slide 30: Tagrisso NSCLC

    Lifecycle management Late-stage development Tagrisso (Highly selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC TKI N ~ 90

31. Slide 31: Nexium Gastrointestinal

    Lifecycle management Late-stage development Nexium Early development - IMED Early development - MedImmune Gastrointestinal Trial phase Patient population Number of patients Design Endpoints Status Phase III Seriously ill patients with at N = 300 • Arm 1: Nexium 40 mg bid intermittent • Clinically si

32. Slide 32: Late-stage development

    AstraZeneca Late-stage development

33. Slide 33: Brodalumab (IL-17R mAb) Psoriasis

    Lifecycle management Late-stage development Brodalumab (IL-17R mAb) Early development - IMED Early development - MedImmune Psoriasis Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to severe plaque N = 661 • Arm 1: 210 mg brodalumab SC • PASI at wk 12 • C

34. Slide 34: PT009 (ICS/LABA) COPD

    Lifecycle management Late-stage development PT009 (ICS/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design (G = Glycopyrronium, F = Formoterol fumarate) Endpoints Status Phase II Moderate t

35. Slide 35: PT010 COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 500 Treatment

36. Slide 36: PT010 COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase II Adult mild to moderate N = 150 • Arm 1: BD

37. Slide 37: PT010 COPD & Asthma

    Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) & Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 72 • Arm 1: BGF MDI

38. Slide 38: Benralizumab (IL-5R mAb) Asthma

    Lifecycle management Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Severe asthma, inadequately N = 1,026 HD + ~200 • Arm 1: 30 mg Q8w SC • Annual asthma

39. Slide 39: Benralizumab (IL-5R mAb) Asthma

    Lifecycle management Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Asthmatic with FEV1 (50-90% N = 200 • Arm 1: 30 mg Q4W SC • Pulmonary function (FEV1)

40. Slide 40: Benralizumab (IL-5R mAb) COPD

    Lifecycle management Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 2,168 • Arm 1: 10 m

41. Slide 41: Tralokinumab (IL-13 mAb) Asthma

    Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase III Adults with uncontrolled N = 1,140 Cohort 1: Primary: • FPD: Q3 2014 STRATOS 1 severe

42. Slide 42: Tralokinumab (IL-13 mAb) Atopic dermatitis

    Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Atopic dermatitis Trial phase Patient population Number of patients Design Endpoints Status Phase II Adults with atopic dermatitis N = 306 • Arm 1: Tralokinumab dose 45mg SC •

43. Slide 43: Anifrolumab SLE

    Lifecycle management Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Trial phase Patient population Number of patients Design Endpoints Status Phase III Moderate to severe SLE N = 450 • Arm 1: 300

44. Slide 44: Anifrolumab Lupus Nephritis

    Lifecycle management Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Lupus Nephritis (LN) Trial phase Patient population Number of patients Design Endpoints Status Phase II Active Proliferative LN (TULIP- N = 150 • Arm 1: 900 mg IV

45. Slide 45: Acalabrutinib Rheumatoid Arthritis

    Lifecycle management Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Trial phase Patient population Number of patients Design Endpoint(s) Status Phase II Rheumatoid Arthritis N=70 • Arm A: Acalabrutinib + methotrexate Disease

46. Slide 46: Roxadustat (HIF-PHI) CKD

    Lifecycle management Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease (CKD) Trial phase Patient population Number of patients Design Endpoints Status Phase III ANDES Anaemia in CKD patients not N = 600 • Arm 1: Roxadustat Haemo

47. Slide 47: Cediranib Ovarian cancer

    Lifecycle management Late-stage development Cediranib (VEGF receptor inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Trial phase Patient population Number of patients Design Endpoints Status Phase III Patients with platinum- N = 486 • Arm 1: Placebo • PFS • FPD: Q2 2

48. Slide 48: Durvalumab NSCLC

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase III Adjuvant NSCLC patients N = 1,100 • Arm 1: MEDI47

49. Slide 49: Durvalumab SCCHN and other solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Squamous Cell Carcinoma of the Head & Neck (SCCHN) and other solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase II SCCHN N =

50. Slide 50: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC N = 480 • Arm 1: ME

51. Slide 51: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase II SCCHN N = 240 • Arm 1: MEDI4736 • ORR • FPD

52. Slide 52: Selumetinib (AZD6244) Solid tumours

    Lifecycle management Late-stage development Selumetinib (AZD6244) (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase III 2L KRASm positive NSCLC N = 500 • Arm 1: Selumetinib 75mg BiD + d

53. Slide 53: Acalabrutinib Haematological malignancies

    Lifecycle management Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Haematological malignancies Trial phase Patient population Number of patients Design Endpoint(s) Status Phase III Relapsed/refractory chronic N = 500 • Arm A: Acalabrutinib PFS

54. Slide 54: Acalabrutinib Haematological malignancies

    Lifecycle management Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Haematological malignancies Trial phase Patient population Number of patients Design Endpoint(s) Status Phase I/II Waldenstrom N = 106 Acalabrutinib monotherapy ORR • FPD: Q3 20

55. Slide 55: Acalabrutinib Solid Tumours

    Lifecycle management Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Solid Tumours Trial phase Patient population Number of patients Design Endpoint(s) Status Phase II ≥ 2L advanced or metastatic N = 74 • Arm A: Pembrolizumab ORR • FPD: Q2 2015 A

56. Slide 56: Moxetumomab pasudotox Haematological malignancies

    Lifecycle management Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Haematological malignancies Trial phase Patient population Number of patients Design Endpoints Status Phase III Adults with relapsed or N = 77 • Multicentre, single-arm

57. Slide 57: CAZ AVI Serious infections

    Lifecycle management Late-stage development CAZ AVI (BLI/cephalosporin SBI) Early development - IMED Early development - MedImmune Serious infections Trial phase Patient population Number of patients Design Endpoints Status Phase III Hospitalised patients with N = 493 • Arm 1: CAZ AVI 2000/500mg plu

58. Slide 58: CAZ AVI Serious infections

    Lifecycle management Late-stage development CAZ AVI (BLI/cephalosporin SBI) Early development - IMED Early development - MedImmune Serious infections Trial phase Patient population Number of patients Design Endpoints Status Phase III Hospitalised patients with N = 486 • Arm 1: CAZ AVI 2000/500mg plu

59. Slide 59: AZD3293 (BACE inhibitor) Alzheimer’s disease

    Lifecycle management Late-stage development AZD3293 (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial phase Patient population Number of patients Design Endpoints Status Phase III Early Alzheimer’s disease N = 2,202 • Arm 1: AZD3293 20 mg once daily •

60. Slide 60: Early development - IMED

    AstraZeneca Early development - IMED

61. Slide 61: Verinurad Gout and hyperuricemia programme

    Lifecycle management Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Trial phase Patient population Number of patients Design Endpoints Status Phase II Monotherapy study in N = 160

62. Slide 62: Verinurad Gout and hyperuricemia

    Lifecycle management Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia Trial phase Patient population Number of patients Design Endpoints Status Phase II Combination therapy N = 40 • Arm A: Placebo • To a

63. Slide 63: AZD7594 Asthma/COPD

    Lifecycle management Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/COPD Trial phase Patient population Number of patients Design Endpoints Status Phase II Patients with mild to moderate N = 48 A randomised, double blind, multiple dosing (

64. Slide 64: AZD7624 (p38 inhibitor) COPD

    Lifecycle management Late-stage development AZD7624 (p38 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase IIa COPD N = 212 • Arm 1: AZD7624, 1.0mg • Effect on

65. Slide 65: AZD7986 (DPP1 inhibitor) COPD

    Lifecycle management Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 152 Part 1 (SAD) • Safety and toler

66. Slide 66: AZD8871 (MABA2) Asthma/COPD

    Lifecycle management Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Asthma/Chronic Obstructive Pulmonary Disease (COPD) Trial phase Patient population Number of patients Design Endpoints Status Phase I Part 1: Mild Asthmatic N (Part 1) = 16 Part 1 Part

67. Slide 67: AZD9412 (Inhaled IFN-beta) Asthma

    Lifecycle management Late-stage development AZD9412 (Inhaled IFN-beta) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase IIa Asthma N = 220 • Arm 1: 24 μg (metered dose) AZD9412 once daily for 14 days • Propo

68. Slide 68: AZD9567 (oSGRM) Rheumatoid Arthritis

    Lifecycle management Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Trial phase Patient population Number of subjects Design Endpoints Status Phase I Healthy Volunteers N = 72 SAD trial with 6 dose levels - 2 μg, 10 μg, 40 μg, 100 μ

69. Slide 69: AZD4076 NASH

    Lifecycle management Late-stage development AZD4076 (anti-miR 103/107) Early development - IMED Early development - MedImmune Non-alcoholic Steatohepatitis (NASH) Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = up to 48 SAD trial • Safety and to

70. Slide 70: AZD0156 (ATM) Solid tumours

    Lifecycle management Late-stage development AZD0156 (ATM) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 130 • Arm 1: AZD0156 + olaparib • Safety, tolerability, pharmacokinetics

71. Slide 71: AZD1775 (WEE-1) Solid tumours

    Lifecycle management Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Solid tumours, ovarian cancer and Non-Small Cell Lung Cancer Trial phase Patient population Number of patients Design Endpoints Status Phase II p53 mutant PSR ovarian N = 120 • Arm 1: C

72. Slide 72: AZD2014 (TORC 1/2)

    Lifecycle management Late-stage development AZD2014 (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous Non-Small Cell Lung Cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase IIa Relapsed or refractory N = 40 Open label •

73. Slide 73: AZD2811 (AURN) Solid tumours

    Lifecycle management Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPD: Q4

74. Slide 74: AZD3759 (EGFRm BBB)

    Lifecycle management Late-stage development AZD3759 (EGFRm BBB) Early development - IMED Early development - MedImmune Non-Small Cell Lung Cancer (NSCLC) with lung and/or brain metastases Trial phase Patient population Number of patients Design Endpoints Status Phase I EGFRm+ NSCLC N = 47 • MAD • Sa

75. Slide 75: AZD4547 (FGFR) Solid tumours

    Lifecycle management Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase II/III Lung Master Stage IIIB-IV NSCLC patients N = 318 (AZD4547 6-Arm trial based on biomar

76. Slide 76: AZD4547 (FGFR) Solid tumours

    Lifecycle management Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced cancer who have N = 94 • Part A: Ascending oral doses of AZD4547 to define maximu

77. Slide 77: AZD5363 (AKT) Solid tumours

    Lifecycle management Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase IIb ER+ breast cancer receiving N = 100 • Arm 1: AZD5363 + paclitaxel • PFS • FPD: Q1 2014 1s

78. Slide 78: Savolitinib (AZD6094) (MET)

    Lifecycle management Late-stage development Savolitinib (AZD6094) (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial phase Patient population Number of patients Design Endpoints Status Phase II Papillary renal cell cancer N = 90 • Single arm tri

79. Slide 79: AZD6738 (ATR) Solid tumours

    Lifecycle management Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPD: Q4 20

80. Slide 80: AZD8186 (PI3Kb/d) Solid tumours

    Lifecycle management Late-stage development AZD8186 (PI3Kb/d) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced Castrate Resistant N = 153 • Part A: AZD8186 monotherapy in ascending intermit

81. Slide 81: AZD9150 (STAT3) Solid and Haematological Cancers

    Lifecycle management Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Solid and Haematological Cancers Trial phase Patient population Number of patients Design Endpoints Status Phase Ib/II Squamous Cell Carcinoma of N = 147 Dose Escalation advanced solid

82. Slide 82: AZD9496 (SERD) Breast cancer

    Lifecycle management Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Trial phase Patient population Number of patients Design Endpoints Status Phase I ER+ Breast Cancer N ~ 150 • This is a Phase I open label multicentre trial of AZD9496 • Pr

83. Slide 83: ATM AVI Infections

    Lifecycle management Late-stage development ATM AVI Early development - IMED Early development - MedImmune Infections Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers • Randomised, double-blind, 3-part trial in healthy young and • Safety/tolerabili

84. Slide 84: AZD3241 (MPO) Multiple System Atrophy

    Lifecycle management Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Multiple System Atrophy (MSA) Trial phase Patient population Number of patients Design Endpoints Status Phase II Parkinson’s disease patients N = 24 • Arm 1: AZD3241 600 mg BID for 8 week

85. Slide 85: AZD8108 (NMDA) Phase I programme

    Lifecycle management Late-stage development AZD8108 (NMDA) Early development - IMED Early development - MedImmune Phase I clinical development programme Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 40 • Randomised, double-blind, placebo-con

86. Slide 86: Early development - MedImmune

    MedImmune Early development - MedImmune

87. Slide 87: Mavrilimumab (GMCSF mAb) Rheumatoid arthritis

    Lifecycle management Late-stage development Mavrilimumab (GMCSF mAb) Early development - IMED Early development - MedImmune Rheumatoid arthritis (RA) Trial phase Patient population Number of patients Design Endpoints Status Phase II RA patients who have failed 1 N = 138 • Arm 1: Mavrilimumab SC • AC

88. Slide 88: MEDI5872 (B7RP-1 mAb) SLE

    Lifecycle management Late-stage development MEDI5872 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Trial phase Patient population Number of patients Design Endpoints Status Phase IIa Primary Sjögren's syndrome N = 42 • Arm 1: MEDI5872 210 mg S

89. Slide 89: MEDI7836 (IL-13 mAb) Asthma

    Lifecycle management Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 32 • Arm 1: 30 mg MEDI7836 (n = 6) or placebo (n = 2) as a single •

90. Slide 90: MEDI9929 (TSLP mAb) Asthma

    Lifecycle management Late-stage development MEDI9929 (TSLP mAb) Early development - IMED Early development - MedImmune Asthma Trial phase Patient population Number of patients Design Endpoints Status Phase II Adult subjects with inadequately N = 552 • Arm 1: Placebo • Reduction in the annualised ast

91. Slide 91: MEDI9314 (IL-4Ra mAb) Atopic Dermatitis

    Lifecycle management Late-stage development MEDI9314 (IL-4Ra mAb) Early development - IMED Early development - MedImmune Atopic Dermatitis Trial phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 44 • Arm 1: 45mg MEDI9314 (n = 4) or placebo (n = 2) as

92. Slide 92: Other biologics Inflammation

    Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Inflammation Trial phase Compound Patient population Number of patients Design Endpoints Status Phase II Anti-IL-23 mAb Patients with moderate N = 121 • Arm 1: MEDI2070, 700mg IV (210mg

93. Slide 93: Other biologics Autoimmunity

    Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Trial phase Compound Patient population Number of patients Design Endpoints Status Phase II/III Inebilizumab Adults with N = 212 (estimated) • Arm 1: MEDI-551 500mg IV • Pr

94. Slide 94: Biologics Cardiovascular & metabolic disease

    Lifecycle management Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic disease Trial phase Compound Patient population Number of patients Design Endpoints Status Phase IIa rhLCAT Adults with stable N = 56 • SAD in stable CAD patients •

95. Slide 95: Durvalumab Immuno-oncology

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune Immuno-oncology Trial phase Compound Patient population Number of patients Design Endpoints Status Phase I/II PD-L1 (durvalumab, Solid tumours N = 1,038 • Dose Escalati

96. Slide 96: Durvalumab + tremelimumab Solid tumours

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase Ib/II Gastric or GEJ N = 174 • Arm A: durvalum

97. Slide 97: Durvalumab + Iressa NSCLC

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) Trial phase Patient population Number of patients Design Endpoints Status Phase I NSCLC N = 36 Escalation phase

98. Slide 98: Durvalumab + Tafinlar/Mekinist Melanoma

    Lifecycle management Late-stage development Durvalumab (MEDI4736; PD-L1 mAb) + Tafinlar Early development - IMED Early development - MedImmune (dabrafenib)/ Mekinist (trametinib) Melanoma Trial phase Patient population Number of patients Design Endpoints Status Phase I/II Metastatic or unresectable

99. Slide 99: MEDI0680 (PD-1 mAb) + durvalumab

    Lifecycle management Late-stage development MEDI0680 (PD-1 mAb) + durvalumab (MEDI4736) Early development - IMED Early development - MedImmune Advanced malignancies Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 150 Dose-escalation phase •

100. Slide 100: MEDI0562 (OX40 mAb) combinations

     Lifecycle management Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + durvalumab (MEDI4736; PD-L1) or tremelimumab (CTLA-4 mAb) Advanced malignancies Trial phase Compound Patient population Number of patients Design Endpoints Sta

101. Slide 101: MEDI6383 (OX40 agonist) + durvalumab

     Lifecycle management Late-stage development MEDI6383 (OX40 agonist) + durvalumab Early development - IMED Early development - MedImmune (MEDI4736; PD-L1 mAb) Advanced malignancies Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 212 Dose-esc

102. Slide 102: Inebilizumab Haematological malignancies

     Lifecycle management Late-stage development Inebilizumab (MEDI-551, CD19 mAb) Early development - IMED Early development - MedImmune Haematological malignancies Trial phase Patient population Number of patients Design Endpoints Status Phase II Adults with relapsed or N = 170 • Arm 1: MEDI-551 dose l

103. Slide 103: MEDI1873 (GITR agonist) Solid tumours

     Lifecycle management Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Adult subjects with select N = 42 Dose-escalation phase • Safety • FPD: Q4 2015 a

104. Slide 104: MEDI4276 (HER2 ADC mAb)

     Lifecycle management Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Advanced malignancies Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced HER2+ metastatic Dose escalation • First-time-in-human Phase 1,

105. Slide 105: MEDI9197 (TLR7/8 agonist) Solid tumours

     Lifecycle management Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced solid tumour N = 45 Dose-escalation phase • Safety • FPD: Q4 2015 mali

106. Slide 106: MEDI9447 (CD73 mAb) + durvalumab

     Lifecycle management Late-stage development MEDI9447 (CD73 mAb) + durvalumab Early development - IMED Early development - MedImmune (MEDI4736; PD-L1 mAb) Advanced malignancies Trial phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 132 Dose-escalat

107. Slide 107: Other biologics Solid tumours

     Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Trial phase Compound Patient population Number of patients Design Endpoints Status Phase I/II Anti-IGF ligand mAb Patients with HR+ N = 176 • Arm 1: MEDI-573 IV and Aromat

108. Slide 108: Other biologics Solid tumours

     Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Trial phase Compound Patient population Number of patients Design Endpoints Status Phase I Anti-CEA BiTE mAb Adults with N = 51 max • Dose-escalation (3+3), IV • MTD and s

109. Slide 109: Vaccine biologics Influenza vaccines

     Lifecycle management Late-stage development Vaccine biologics Early development - IMED Early development - MedImmune Influenza vaccines Trial phase Compound Patient population Number of patients Design Endpoints Status Phase III MEDI3250 Children 2 to 6 years N = 100 • Open-label • Safety and tolera

110. Slide 110: Other biologics Infections

     Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Trial phase Compound Patient population Number of patients Design Endpoints Status Phase II Anti-Staph AT Intubated ICU N = 462 • Placebo-controlled, single-dose, dose-rangin

111. Slide 111: MEDI1814 (amyloid beta mAb) Alzheimer’s disease

     Lifecycle management Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial phase Patient population Number of patients Design Endpoints Status Phase I Alzheimer’s disease & healthy N = 121 • SAD & MAD • Safety, tolerabilit

112. Slide 112: Clinical trials appendix Q1 2016 update

     Clinical trials appendix Q1 2016 update

AstraZeneca — Q1 2016 Earnings Presentation on 6ix