Sanofi Sa · EURONEXT:SAN
Sanofi Sa — American College of Cardiology (ACC) investor call, Orlando, 2018
30 slides from Sanofi Sa's conference presentation, Mar 10, 2018
Slide 1: Results of ODYSSEY OUTCOMES Trial
Results of ODYSSEY OUTCOMES Trial Evaluation of long-term cardiovascular outcomes after Acute Coronary Syndrome (ACS) during treatment with Praluent® (alirocumab) Investor call at ACC, Orlando, March 10, 2018
Slide 2: Sanofi Forward-Looking Statements
Sanofi Forward-Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and thei
Slide 3: Regeneron Forward-Looking Statements
Regeneron Forward-Looking Statements This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially f
Slide 4: Agenda
Agenda Opening remarks ● Olivier Brandicourt, MD - Chief Executive Officer, Sanofi ● Leonard S. Schleifer, MD, PhD - Founder, President and Chief Executive Officer, Regeneron Detailed Review of ODYSSEY OUTCOMES data ● Dr Eric Peterson, MD, MPH, FAHA, FACC - Distinguished Professor of Medicine in the
Slide 5: Opening Remarks
Opening Remarks ● Olivier Brandicourt, MD - Chief Executive Officer, Sanofi ● Leonard S. Schleifer, MD, PhD - Founder, President and Chief Executive Officer, Regeneron
Slide 6: Patients with a History of ACS and High LDL-C Represent a High Risk Population
Patients with a History of ACS and High LDL-C Represent a High Risk Population in CVD, A Major Global Unmet Need ● Cardiovascular disease kills more people worldwide than any other disease #1 ~17.7m ● Patients with acute coronary syndrome Worldwide Deaths Cause of death globally(1) (ACS), such as he
Slide 7: The Majority of Patients Do Not Achieve LDL-C Targets on Statin Therapy
The Majority of Patients Do Not Achieve LDL-C Targets on Statin Therapy ● Due to a variety of reasons, at least 50% of patients discontinue statins within 1 year of treatment initiation(1) ● Statin intolerance occurs in up to 15% of patients(2) Patient Population on Statin Therapy Patients that rema
Slide 8: ODYSSEY OUTCOMES is the First Non-Statin, Lipid-Lowering Study to Reduce All-Cause Mortality
ODYSSEY OUTCOMES is the First Non-Statin, Lipid-Lowering Study to be Associated with a Reduction of All-Cause Mortality(1) 4S Study was First to Show that Discovery of First Statin Study to Show a Statin Could Reduce Both CV PCSK9 the LDL-C All-Cause Mortality Benefit: 4S and All-Cause Mortality Fro
Slide 9: Detailed Review of ODYSSEY OUTCOMES Data
Detailed Review of ODYSSEY OUTCOMES Data ● Dr Eric Peterson, MD, MPH, FAHA, FACC - Distinguished Professor of Medicine in the Division of Cardiology and Executive Director of the Duke Clinical Research Institute
Slide 10: Treatment Assignment
ACC.18 Treatment Assignment Post-ACS patients (1 to 12 months) Run-in period of 2−16 weeks on high-intensity or maximum-tolerated dose of atorvastatin or rosuvastatin At least one lipid entry criterion met Randomization Alirocumab SC Q2W Placebo SC Q2W Patient and investigators remained blinded to t
Slide 11: Patient Disposition
ACC.18 Patient Disposition Randomized 18,924 patients Alirocumab Placebo (N=9462) (N=9462) Follow-up*: median 2.8 (Q1–Q3 2.3–3.4) years 8242 (44%) patients with potential follow-up ≥3 years 1955 patients experienced a primary endpoint 726 patients died • Premature treatment discontinuation 1343 (14.
Slide 12: LDL-C: ITT and On-Treatment Analyses
ACC.18 LDL-C: ITT and On-Treatment Analyses 103.1 Placebo 105 96.4 ITT 93.3 101.4 On-treatment* 90 Mean LDL-C (mg/dL) 75 66.4 Alirocumab ITT† 60 48.0 On-treatment* 45 39.8 53.3 42.3 30 37.6 15 0 0 4 8 12 16 20 24 28 32 36 40 44 48 Months Since Randomization *Excludes LDL-C values after premature tre
Slide 13: Primary Efficacy Endpoint: MACE
ACC.18 Primary Efficacy Endpoint: MACE ARR* 1.6% HR 0.85 (95% CI 0.78, 0.93) MACE: CHD death, P=0.0003 non-fatal MI, ischemic stroke, or unstable angina requiring hospitalization *Based on cumulative incidence 13
Slide 14: Primary Efficacy and Components
ACC.18 Primary Efficacy and Components Alirocumab Placebo Log-rank Endpoint, n (%) HR (95% CI) (N=9462) (N=9462) P-value MACE 903 (9.5) 1052 (11.1) 0.85 (0.78, 0.93) 0.0003 CHD death 205 (2.2) 222 (2.3) 0.92 (0.76, 1.11) 0.38 Non-fatal MI 626 (6.6) 722 (7.6) 0.86 (0.77, 0.96) 0.006 Ischemic stroke 1
Slide 15: All-Cause Death
ACC.18 All-Cause Death ARR† 0.6% HR 0.85 (95% CI 0.73, 0.98) P=0.026* *Nominal P-value †Based on cumulative incidence 15
Slide 16: Post Hoc Analysis: All-Cause Death by Baseline LDL-C Subgroups
ACC.18 Post Hoc Analysis: All-Cause Death by Baseline LDL-C Subgroups ARR* 1.7% Pinteraction=0.12 <80 mg/dL 80 to <100 mg/dL ≥100 mg/dL HR 0.89 HR 1.03 HR 0.71 (95% CI 0.69, 1.14) (95% CI 0.78, 1.36) (95% CI 0.56, 0.90) *Based on cumulative incidence 16
Slide 17: Efficacy: Subgroup with Baseline LDL-C 100 mg/dL
ACC.18 Efficacy: Subgroup with Baseline LDL-C 100 mg/dL (Median Baseline LDL-C 118 mg/dL) Alirocumab Placebo Absolute Endpoint, n (%) HR (95% CI) (N=2814) (N=2815) risk reduction (%) MACE 324 (11.5) 420 (14.9) 3.4 0.76 (0.65, 0.87) CHD death 69 (2.5) 96 (3.4) 1.0 0.72 (0.53, 0.98) CV death 81 (2.9)
Slide 18: Safety (1)
ACC.18 Safety (1) Treatment-emergent adverse events, Alirocumab Placebo n (%) (N=9451) (N=9443) Any 7165 (75.8) 7282 (77.1) Serious 2202 (23.3) 2350 (24.9) Laboratory value Alirocumab Placebo ALT >3 ULN, n/N (%) 212/9369 (2.3) 228/9341 (2.4) Creatine kinase >10 ULN, n/N (%) 46/9369 (0.5) 48/9338
Slide 19: Safety (2)
ACC.18 Safety (2) Alirocumab Placebo Event (N=9451) (N=9443) Diabetes worsening or diabetic complications: pts 506/2688 (18.8) 583/2747 (21.2) w/DM at baseline, n/N (%) New onset diabetes; pts w/o DM at baseline, n/N (%) 648/6763 (9.6) 676/6696 (10.1) General allergic reaction, n (%) 748 (7.9) 736 (
Slide 20: Conclusions
ACC.18 Conclusions Compared with placebo in patients with recent ACS, alirocumab 75 or 150 mg subcutaneous Q2W targeting LDL-C levels 25–50 mg/dL, and allowing levels as low as 15 mg/dL: 1. Reduced MACE, MI, and ischemic stroke 2. Was associated with a lower rate of all-cause death 3. Was safe and w
Slide 21: Clinical Perspective
ACC.18 Clinical Perspective • In this nearly 19,000-patient placebo-controlled trial, including many patients treated for ≥3 years, there was no safety signal with alirocumab other than injection site reactions 21
Slide 22: Clinical Perspective
ACC.18 Clinical Perspective • In this nearly 19,000-patient placebo-controlled trial, including many patients treated for ≥3 years, there was no safety signal with alirocumab other than injection site reactions • Among patients with ACS and baseline LDL-C 100 mg/dL, alirocumab reduced MACE by 24% (
Slide 23: Praluent Value Proposition
Praluent® Value Proposition ● Jay Edelberg, MD, PhD - Vice President, Global Cardiovascular Development, Sanofi ● Marion McCourt - Senior Vice President and Head of Commercial, Regeneron
Slide 24: ODYSSEY Phase 3 Program - Consistent Positive Results
ODYSSEY Phase 3 Program - Consistent Positive Results 22 global trials, including more than 29,300 patients across more than 3,000 study centers HeFH population HC in high CV risk population Additional populations/studies Add-on to max tolerated statin (± other LMT) Add-on to max tolerated statin (±
Slide 25: ODYSSEY OUTCOMES Provides Strong Clinical Evidence of Patient Benefit
ODYSSEY OUTCOMES Provides Strong Clinical Evidence of Patient Benefit from Long-Term Therapy with Praluent®(1) Transformational Study Positive Results Patient Impact ● High risk patients with ACS event ● Primary endpoint met: ● Greatest clinical benefit between 1 and 12 months Significant reduction
Slide 26: Sanofi and Regeneron Committed to Make Praluent Accessible for Patients
Sanofi and Regeneron Committed to Make Praluent® Accessible for Patients with Greatest Health Risk and Unmet Need ● Precision medicine approach High-Risk Patients ● For payers willing to will focus efforts on high-risk reduce access barriers for patients, such as those who high-risk patients, have h
Slide 27: Concluding remarks
Concluding remarks ● Olivier Brandicourt, MD - Chief Executive Officer, Sanofi ● Leonard S. Schleifer, MD, PhD - Founder, President and Chief Executive Officer, Regeneron
Slide 28: Building the Opportunity for Praluent Based on Strong Body of Clinical Data
Building the Opportunity for Praluent® Based on Strong Body of Clinical Data from ODYSSEY Study Program Engage with healthcare providers to address high risk patient population Increase access for appropriate patients by working together with payers Submission to regulators for label inclusion of OD
Slide 29: ODYSSEY OUTCOMES Establishes the Platform to Optimize Long-Term Benefits of Praluent
ODYSSEY OUTCOMES Establishes the Platform to Optimize the Long-Term Benefits of Praluent® Treatment for Patients Met primary endpoint with 15% RRR of major CV events / MACE The first non-statin, lipid-lowering trial to be associated with a reduction in all-cause mortality (nominal p=0.026) For
Slide 30: Q&A Session
Q&A Session ● Olivier Brandicourt, MD - Chief Executive Officer, Sanofi ● Leonard S. Schleifer, MD, PhD - Founder, President and Chief Executive Officer, Regeneron ● Dr Eric Peterson, MD, MPH, FAHA, FACC - Distinguished Professor of Medicine in the Division of Cardiology and Executive Director of th
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