Amgen Inc. · NASDAQ:AMGN
Amgen — Technical Presentation (November 2024)
30 slides from Amgen's technical presentation, Nov 26, 2024
Slide 1: MariTide Update
MariTide Update November 26, 2024
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outco
Slide 3: Today's Presenters
Today’s Presenters Bob Bradway Jay Bradner Susan Sweeney Chairman and Executive Vice President, Executive Vice President, Chief Executive Officer Research and Development, Obesity and Related Conditions and Chief Scientific Officer 3 Provided November 26, 2024, as part of an oral presentation and is
Slide 4: MariTide Has a Unique, Differentiated and Competitive Profile
MariTide Has a Unique, Differentiated and Competitive Profile • MariTide demonstrates robust weight loss at 52 weeks without a weight loss plateau in people living with obesity or overweight • MariTide is the first obesity treatment with monthly or less frequent dosing to demonstrate safe and effect
Slide 5: MariTide is a First-of-its-Kind Peptide Antibody Conjugate
MariTide MariTide is a First-of-its-Kind Peptide (maridebart cafraglutide, AMG 133) Antibody Conjugate That Activates the Mode of Action GLP-1 Receptor and Antagonizes GIPR MONOCLONAL ANTIBODY BACKBONE Long half-life with sustained, predictable exposure SYNERGISTIC EFFECT Two GLP-1 receptors activat
Slide 6: Overview of MariTide Phase 2 Study (Part 1)
Overview of MariTide Phase 2 Study (Part 1) • 52 weeks • 2 cohorts 1. Adults living with obesity or overweight WITHOUT Type 2 diabetes 2. Adults living with obesity or overweight WITH Type 2 diabetes • 592 adult patients • 11 arms, including 2 rapid dose escalations arms • Monthly or less frequent d
Slide 7: Patients with Obesity or Overweight WITHOUT Type 2 Diabetes
Patients with Obesity or Overweight WITHOUT Type 2 Diabetes
Slide 8: Phase 2 Study Evaluated Multiple Dosing Options, Including Two Dose Escalation Arms
MariTide Phase 2 Study Evaluated Multiple Dosing Options, Including Two Dose Escalation Arms Obesity or Overweight WITHOUT Type 2 Diabetes (n=465) 140 mg monthly 280 mg monthly 420 mg monthly 420 mg every other month Placebo DOSE ESCALATION ARMS 70 mg 70 mg 4-week dose escalation then 420 mg monthly
Slide 9: Select Baseline Characteristics
Select Baseline Characteristics Adults living with obesity or overweight without Type 2 diabetes (n=465) SEX RACE Mean Weight Mean BMI MALE WHITE 67% 107kg 38kg/m 2 37% ASIAN 22% Mean Waist Circumference FEMALE 63% BLACK 7% 115cm OTHER 4% kg = kilogram; kg/m2 = kilogram per meter squared; cm = centi
Slide 10: Demonstrated up to ~20% Average Weight Loss at 52 Weeks Without a Plateau
MariTide Demonstrated up to ~20% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau • Substantial and statistically 0 significant weight loss in all dose arms -2.5 Percent Change in Body Weight • Dose escalation resulted estimated mean (95% CI) -5 in similar magnitude of weight -7.5 loss
Slide 11: Robust Improvements in Cardiometabolic Parameters at 52 Weeks
MariTide Demonstrated Robust And Clinically Meaningful Improvements in Cardiometabolic Parameters at 52 Weeks SELECT CARDIOMETABOLIC CHANGE FROM BASELINE TO W52 CHANGE FROM BASELINE TO W52 RISK FACTORS FOR PLACEBO FOR POOLED 420 MARITIDE DOSE ARMS Systolic blood pressure - 3 mmHg - 11 mmHg* LDL-C +1
Slide 12: Patients with Obesity or Overweight WITH Type 2 Diabetes
Patients with Obesity or Overweight WITH Type 2 Diabetes
Slide 13: Phase 2 Study Evaluated Multiple Dosing Options
MariTide Phase 2 Study Evaluated Multiple Dosing Options OBESITY or Overweight WITH Type 2 Diabetes (n=127) 140 mg monthly 280 mg monthly 420 mg monthly Placebo 0 4 8 12 16 20 24 28 32 36 40 44 48 52 WEEKS mg = milligrams. 13 Provided November 26, 2024, as part of an oral presentation and is qualifi
Slide 14: Select Baseline Characteristics
Select Baseline Characteristics Adults living with obesity or overweight and Type 2 diabetes (n=127) SEX RACE Mean Weight Mean Hemoglobin A1C MALE WHITE 68% 104kg 7.9% 58% ASIAN 24% Mean BMI Mean Waist Circumference FEMALE 42% BLACK 7% 36kg/m2 117cm kg = kilogram; kg/m2 = kilogram per meter squared;
Slide 15: Up to ~17% Average Weight Loss at 52 Weeks Without a Plateau
MariTide Delivered an Impressive up to ~17% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau • Impressive ~17% weight loss at 52 weeks in patients 0 with Type 2 diabetes -2 Percent Change in Body Weight • Substantial and statistically estimated mean (95% CI) -4 significant weight loss i
Slide 16: Significantly Reduced HbA1c in Adults With Type 2 Diabetes
MariTide Significantly Reduced HbA1c in Adults Living With Obesity or Overweight With Type 2 Diabetes Change in HbA1c Percentage Points Placebo 140 mg monthly 1 280 mg monthly 420 mg monthly 0 -1 -2 -2.2% -3 0 12 24 36 52 Weeks *statistically significant aThese and all subsequent efficacy data repor
Slide 17: Improvements in Additional Cardiometabolic Parameters at 52 Weeks
MariTide Demonstrated Robust and Clinically Meaningful Improvements in Additional Cardiometabolic Parameters at 52 Weeks SELECT CARDIOMETABOLIC CHANGE FROM BASELINE TO W52 CHANGE FROM BASELINE TO W52 RISK FACTORS FOR PLACEBO FOR MARITIDE 420 mg MONTHLY HbA1c +0.1% - 2.2%* Glucose +22 mg/dL - 58 mg/d
Slide 18: Safety and Tolerability
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Slide 19: No Additional Safety Signals Identified Through 52 Weeks
No Additional Safety Signals Were Identified Through 52 Weeks in the MariTide Phase 2 Study • All arms were successfully completed, the large majority of patients finished the study and >90% of eligible patients chose to continue on study for another year • No association between the administration
Slide 20: Most Common Adverse Events Were GI Related
The Most Common Adverse Events Were GI Related, Including Nausea, Vomiting and Constipation • Across all dose arms, GI events were predominately mild to moderate, transient, and primarily associated with the first dose • Dose escalation significantly improves GI tolerability GI = gastrointestinal. 2
Slide 21: Dose Escalation Improved GI Tolerability in the Phase 2 Study
Dose Escalation Improved GI Tolerability in the Phase 2 Study, With Further Improvements Expected • Dose escalation was employed in two arms, each with an initial dose of 70 mg ◦ Dose escalation periods were 4 weeks and 12 weeks • Improved GI tolerability with this limited dose escalation ◦ Disconti
Slide 22: After the First Dose, Most Patients Did Not Experience Nausea or Vomiting
In the Dose Escalation Arms, After the First Dose SEVERE the Vast Majority of Patients Did Not Experience MODERATE MILD Nausea or Vomiting Events 420 mg 4-week Dose Escalation 420 mg 12-week Dose Escalation Nausea 0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Weeks We
Slide 23: Ongoing Phase 1 Pharmacokinetic Study of Additional Dose Escalation Regimens
Ongoing Phase 1 Pharmacokinetic Study of Additional Dose Escalation Regimens Starting at Lower Doses of MariTide DAY 1 RANDOMIZATION 1:1:1 N= 121 DAY 15 DAY 29 Target dose g m 0 7 21 mg 70 mg Continued END OF 35 mg 70 mg Target dose Follow-up STUDY 70 mg 70 mg Target dose Dose escalation with lower
Slide 24: Part 2 of the Phase 2 Study Will Evaluate Additional Weight Loss and Durability
Part 2 of the Phase 2 Study Will Evaluate Additional Weight Loss, Weight Maintenance and Durability Beyond 52 Weeks PART 1 (52 weeks) PART 2 (52 weeks) Participants with >15% body weight reduction in Part 1 were eligible for Part 2 Placebo Placebo 140 mg monthly Placebo 280 mg monthly 70 mg monthly
Slide 25: Key Takeaways
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Slide 26: MariTide Phase 2 Data Highlight a Unique, Differentiated and Competitive Profile
MariTide Phase 2 Data Highlight a Unique, Differentiated and Competitive Profile Key Takeaways • Up to ~20% average weight loss at 52 weeks without a weight loss plateau in patients without Type 2 diabetes • First obesity treatment with monthly or less frequent dosing • Up to ~17% average weight los
Slide 27: Looking Ahead
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Slide 28: Announcing MARITIME Clinical Development Program
Announcing MARITIME Clinical Development Program POTENTIAL INDICATIONS INCLUDE: www.maritimestudy.com Advancing Additional Assets in Our Obesity Portfolio 28 Provided November 26, 2024, as part of an oral presentation and is qualified by such, contains forward-looking statements, actual results may
Slide 29: MariTide Supply
MariTide Supply • MariTide will be delivered as a single dose in a convenient, handheld, patient-friendly, autoinjector device with a monthly or less frequent single-injection administration • MariTide can be manufactured on our standard platform, which enables efficient use of existing facilities a
Slide 30: Questions?
QUESTIONS? _ {ye Gap GD 430 . GD 4 p> GED © GED GED @ Dp O@GD =, aD @u :