1. PCSK9 Inhibitors Post-CVOTs

2. Background

3. FOURIER Trial Design

4. FOURIER: Lower CV Event Rates With Lower LDL-C Levels,
FOURIER: Lower CV Event Rates With Lower LDL-C Levels,* Even Down to 20 mg/dL

5. The SPIRE-2 Cardiovascular Outcomes Trial: Baseline LDL-C ≥ 100 mg/dL Primary Prespecified Endpoint*

6. Topline Results

7. Main Inclusion Criteria

8. Key Exclusion Criteria

9. Primary Efficacy Outcome

10. Major Secondary Efficacy Endpoints

11. Treatment Assignment

12. A Target Range for LDL-C

13. Statistical Considerations

14. ODYSSEY OUTCOMES 18,924 Patients Randomized at 1315 Sites in 57 Countries, November 2, 2012-November 11, 2017

15. Patient Disposition

16. Baseline Demographics

17. Baseline Index Events

18. Baseline Lipid Characteristics

19. Baseline Lipid-Lowering Therapy

20. Guideline-Recommended Post-ACS Medications

21. LDL-C ITT and On-Treatment Analyses

22. LDL-C On-Treatment Analysis

23. Primary Efficacy Endpoint MACE

24. Primary Efficacy and Components

25. Main Secondary Efficacy Endpoints Hierarchical Testing

26. All-Cause Death

27. Primary Efficacy in Main Prespecified Subgroups

28. Efficacy Subgroup With Baseline LDL-C  100 mg/dL (Median Baseline LDL-C 118 mg/dL)

29. Safety (1)

30. Safety (2)

31. Conclusions

32. Clinical Perspective

33. ODYSSEY OUTCOMES vs FOURIER Patient Histories

34. ODYSSEY OUTCOMES vs FOURIER LLTs and Lipids

35. ODYSSEY OUTCOMES vs FOURIER Primary Endpoints

36. PCSK9 CVOTs Key Scientific Points

37. 2013 ACC/AHA Statin Therapy Recommendations

38. Pyramid of Risk

39. Barriers in Access to CVD Therapies: PCSK9 Inhibitors

40. Alirocumab and Evolocumab US Labelling and Indications

41. Alirocumab and Evolocumab European Labeling and Indications

42. Access to PCSK9 Inhibitors

43. FH Foundation's Findings: Access to Nonstatin LLTs in Patients at High Risk of ASCVD or With ASCVD

44. Access Barrier Through Prior Authorization and High Copays

45. CLC Consensus Paper: Open Access

46. Pragmatic Tools to Gain PCSK9 mAb Access for Appropriate Patients

47. Interprofessional Care Team

48. Abbreviations

49. Abbreviations (cont)