Pfizer, Inc. · NYSE:PFE
Pfizer — European Association for the Study of Diabetes (EASD) Annual Meeting 2022
31 slides from Pfizer's conference presentation, Sep 21, 2022
Slide 1: Analyst and Investor Call to Review Oral GLP-1 Data
Analyst and Investor Call to Review Oral GLP-1 Data The European Association for the Study of Diabetes (EASD) Annual Meeting, Stockholm September 21, 2022 Breakthroughs that change patients’ lives 1
Slide 2: Forward-Looking Statements and Other Notices
Forward-Looking Statements and Other Notices This presentation and our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially f
Slide 3: Today's Speakers
Today’s Speakers Bill Sessa Aditi Saxena Andy Schmeltz Jim Rusnak SVP, Chief Scientific Officer, VP, Clinical Research Head, SVP, Commercial SVP, Chief Development Officer, Internal Medicine Internal Medicine Strategy & Innovation Internal Medicine & Hospital (Q&A Session Only) Analyst and Investor
Slide 4: "Diabesity" Unmet Medical Need
“Diabesity” Unmet Medical Need Bill Sessa SVP, Chief Scientific Officer, Internal Medicine Breakthroughs that change patients’ lives 4
Slide 5: Obesity and Type 2 Diabetes – Significant Unmet Need Remains
Obesity and Type 2 Diabetes – Significant Unmet Need Remains Chronic medical conditions that can lead to serious CV, metabolic and other health consequences Rising Rates of Obesity and Diabetes Carry Significant Health Consequences Obesity Diabetes (Globally) (Globally) Today 650M2 Today 537M *By 20
Slide 6: Obesity – A Driver of Comorbidities
Obesity – A Driver of Comorbidities Cardiovascular Metabolic Structural ~200 Inflammatory Complications Affecting EVERY Organ System and Medical Specialty Degenerative Neoplastic (Cancer) Psychological 1. Yuen MM et al. A Systematic Review and Evaluation of Current Evidence Reveals 195 Obesity-Assoc
Slide 7: GLP-1 Receptor Agonists Are Well-suited to Tackle Obesity and Type 2 Diabetes
GLP-1 Receptor Agonists Are Well-suited to Tackle Obesity and Type 2 Diabetes Class of medicines addresses key drivers of these diseases GLP-1 Receptor Agonists (GLP-1RAs) Decreased Delayed Gastric Increased Appetite Emptying Insulin Secretion GLP-1RAs Have Been Shown to Have Effects on Weight Loss,
Slide 8: Pfizer In-House Innovation Delivers Potential Best-In-Class Investigational Oral GLP-1 Receptor Agonists
Pfizer In-House Innovation Delivers Potential Best-In-Class Investigational Oral GLP-1 Receptor Agonists Prior Industry-wide Efforts Failed to Identify Potent and Efficacious Small-molecule Agonists of the GLP-1R Sensitized Screening Assay Danuglipron Plasma Concentration PF-07081532 Plasma Concentr
Slide 9: Today's New Data for Danuglipron and PF-07081532
Today’s New Data for Danuglipron and PF-07081532 Aditi Saxena VP, Clinical Research Head, Internal Medicine Breakthroughs that change patients’ lives 9
Slide 10: Clinical Studies Presented at EASD 2022
Clinical Studies Presented at EASD 2022 Danuglipron • Oral small molecule GLP-1 receptor agonist danuglipron (PF-06882961) results in glucose lowering and body weight loss over 16 weeks in a Phase 2b study in adults with Type 2 diabetes mellitus (EASD Abstract #589) • Efficacy, safety and tolerabili
Slide 11: Danuglipron Phase 2b study results over 16 weeks in type 2 diabetes
Oral small molecule GLP-1 receptor agonist danuglipron (PF-06882961) results in glucose lowering and body weight loss over 16 weeks in a Phase 2b study in adults with Type 2 diabetes mellitus Aditi R Saxena1, Juan Frias 2, Lisa S Brown3, Donal N Gorman4, Nikolaos Tsamandouras 1, Morris J Birnbaum1*
Slide 12: Introduction, Objectives and Study Design
Introduction, Objectives and Study Design • Objectives and study design: Phase 2b, randomized, placebo-controlled, parallel group, dose-ranging study to examine the effect of danuglipron on efficacy, safety, tolerability and pharmacokinetics over 16 weeks in adults with T2D (NCT03985293) • Primary e
Slide 13: Significant, Dose-responsive Declines in HbA1c
Significant, Dose-responsive Declines in HbA1c All danuglipron groups demonstrated statistically significant dose-responsive declines from baseline in HbA1c at Week 16 compared with placebo (all P<0.0001, except 2.5 mg BID which was P<0.01) HbA1c: Change from Baseline at Week 16 HbA1c: Change from B
Slide 14: Significant Reduction in Fasting Plasma Glucose Over Weeks
Significant Reduction in Fasting Plasma Glucose Over 16 Weeks At Week 16, FPG was statistically significantly reduced with all danuglipron doses compared with placebo (P<0.001 for all doses ≥10 mg BID; P<0.1 for 2.5 mg BID) FPG: Change from baseline at Week 16 FPG: Change from Baseline Through The S
Slide 15: Significant Decline in Body Weight Over Weeks
Significant Decline in Body Weight Over 16 Weeks Body weight was statistically significantly reduced at Week 16 in the danuglipron 80 mg BID and 120 mg BID groups (both P<0.001), compared with placebo Body Weight: Change from Baseline at Week 16 Body Weight: Change from Baseline Through the Study 2
Slide 16: Danuglipron Phase 2a study over 12 weeks in type 2 diabetes
Efficacy, safety and tolerability of danuglipron (PF-06882961) over 12 weeks in Phase 2a study in adults with Type 2 diabetes mellitus Donal N Gorman1, Aditi R Saxena2, Juan Frias3, Rene N Lopez4, Nikolaos Tsamandouras2, Morris J Birnbaum2* 1 Pfizer Worldwide Research and Development, Cambridge, UK;
Slide 17: Danuglipron – Potent Glycemic and Weight Loss Efficacy After 12 Weeks
Danuglipron – Potent Glycemic and Weight Loss Efficacy After 12 Weeks Decrease in HbA1c After 12 Week Treatment 1 Reduction in Body Weight after 12-week Treatment1 Placebo Danuglipron 200 mg BID Placebo Danuglipron 200 mg BID Bodyweight Reduction (kg) HbA1c Reduction (%) -0.4 (-0.6%) -0.32 -1.57 -5.
Slide 18: PF-07081532 Phase 1b study in type 2 diabetes and obesity
Once-daily oral small molecule GLP-1R agonist PF-07081532 robustly reduces glucose and body weight within 4-6 weeks in a Phase 1b in adults with Type 2 diabetes and non-diabetic adults with obesity Clare Buckeridge1, Nikolaos Tsamandouras1, Santos Carvajal-Gonzalez1, Lisa S Brown2, Kristin L Chidsey
Slide 19: Study Design Overview
Study Design Overview • Inpatient study (NCT05158244) conducted at 2 clinical research units in the United States • 6 cohorts were enrolled: 5 cohorts of participants with T2D and 1 cohort with obesity • PF-07081532 or placebo administered once daily, with breakfast • Rapid titration used to achieve
Slide 20: PF-07081532 Pharmacokinetic Profile Following Last Dose
PF-07081532 Pharmacokinetic Profile Following Last Dose • PF-07081532 exposure (AUC24 and Cmax) generally increased in an approximately dose-proportional manner across the dose range studied • Observed half-life is supportive of once-daily administration • No substantial differences in exposure obse
Slide 21: Robust Declines in Mean Daily Glucose with Once-daily PF-07081532 in Participants with T2D
Robust Declines in Mean Daily Glucose with Once-daily PF-07081532 in Participants with T2D 0 baseline in MDG (mg/dL) at end of treatment Posterior mean (90% CI) change from Observed mean reductions from baseline in -40 -29.1 MDG were dose-dependent -47.8 Each of the PF-07081532 doses were -80 -64.2
Slide 22: Fasting Plasma Glucose Approaching Non-diabetic Thresholds with Once-daily PF-07081532
Fasting Plasma Glucose Approaching Non-diabetic Thresholds with Once-daily PF-07081532 in Participants with T2D 0 LS mean (SE) change from baseline in FPG (mg/dL) at end of treatment Observed average reductions from baseline in FPG were up to -79 mg/dL over 28 days and -40 up to -102 mg/dL over 42 d
Slide 23: Dose-responsive Weight Reduction with Once-daily PF-07081532 for 4 to 6 Weeks
Dose-responsive Weight Reduction with Once-daily PF-07081532 for 4 to 6 Weeks 0 LS mean (SE) change from baseline in weight (kg) at end of treatment -1 While longer duration of intervention is -2 required to assess the effect of treatment on body weight, reductions were observed -3 following dosing
Slide 24: Pfizer Oral GLP-1 Data in T2D and Obesity Support Potential Best-in-Class Efficacy and Tolerability
Pfizer Oral GLP-1 Data in T2D and Obesity Support Potential Best-in-Class Efficacy and Tolerability Summary: Danuglipron Phase 2 Data Summary: ‘1532 Phase 1b Data Over 12-16 Weeks Over 4-6 Weeks • Reductions in HbA1c, FPG and body weight in • Dose-dependent reductions from baseline in T2D at multipl
Slide 25: Moving Forward – Clinical Development Program
Moving Forward – Clinical Development Program Breakthroughs that change patients’ lives 25
Slide 26: GLP-1 Clinical Development Plan
GLP-1 Clinical Development Plan Danuglipron Recently Completed Ongoing Phase 2b (16-wk) dose-ranging study (T2DM) – NCT03985293 Phase 2b study* (Obesity) – NCT04707313 – Phase 2a (12-wk) titration study anticipated completion 2H23 (T2DM) – NCT04617275 Plan to Advance One Candidate to Phase 3 (T2DM a
Slide 27: Best-in-Class Potential with Significant Market Opportunity
Best-in-Class Potential with Significant Market Opportunity Andy Schmeltz SVP, Commercial Strategy & Innovation Breakthroughs that change patients’ lives 27
Slide 28: GLP-1RA Class Growing Rapidly with Increasing Recognition as a Highly Effective Treatment
GLP-1RA Class Growing Rapidly with Increasing Recognition of Class as a Highly Effective Treatment for HbA1c Control and Weight Loss • Large ($25B) GLP-1 market growing Obesity Rx Formulary Coverage rapidly at a rate of >30%1, fueled by: 80–90% • CV outcomes in T2D • Treatment guideline updates 30%
Slide 29: Clear Patient Preference for Oral GLP-1RA Dosing
Clear Patient Preference for Oral GLP-1RA Dosing Orals expected to capture a significant proportion of the market due to patient preference (ease of use)1 Type 2 Diabetes Only Obesity + Type 2 Diabetes Obesity Only (n=83) (n=110) (n=112) 13% 9% 14% 30% 32% 24% 68% 61% 48% BID oral, no fasting QD ora
Slide 30: Innovative Research Led to Discovery of Potential Best-in-Class Small Molecule GLP-1RAs
Innovative Research Led to Discovery of Potential Best-in-Class Small Molecule GLP-1RAs Two Candidates in Phase 2 with Potential to Offer a Uniquely Differentiated Profile and Secure a Significant Share of the Oral GLP-1 Market An approved oral small molecule GLP-1RA has the potential to: • Deliver
Slide 31: Questions? Answers.
Questions? Answers. Analyst and Investor Call to Review Oral GLP-1 Data 31
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