Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — J.P. Morgan Healthcare Conference 2025
26 slides from Amphastar Pharmaceuticals's conference presentation, January 2025
Slide 1: J.P. Morgan Healthcare Conference, January 2025
Injectables Biosimilar Inhalation Interchangeable Intranasal Proprietary Complex Highly Purified Generic Peptide/Protein Combination J. P. Morgan Healthcare Conference Products January 2025
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements, of Amphastar Pharmaceuticals, Inc. (“Amphastar”, “we”. “our” and that are based on our management’s current expectations and assumptions and on information currently available to m
Slide 3: Company Overview
Company Overview &-Yanerastar 3
Slide 4: Company Overview
Company Overview Dual One- Strategies Three-H Stop Growth Focus Model ■ High Quality ■ Fully Integrated ■ Pipeline Development Business Model, ■ High Efficiency R&D, Manufacturing ■ Strategic Acquisitions and Distribution ■ High Technology 4
Slide 5: Fully Integrated Business Model: One-Stop
Fully Integrated Business Model: One-Stop ■ Extensive in-house product Product Development development capabilities − Technical Platforms − State-of-the-art instruments API / Key − Animal studies Components − Clinical research team Manufacturing ■ Control over US Based Finished quality and complianc
Slide 6: Dual-Strategies Growth Model
Dual-Strategies Growth Model Dual-Strategies Primary - Secondary - Organic Growth Inorganic Growth Pipeline Strategic Development Acquisition Primatene Glucagon MIST® Injection Insulin AFP Baqsimi® Analog Armstrong NDA, ANDA, IN NDAs NDA, Highly- BLA, rDNA MDI, MDI Facility Powder IN Purified rDNA F
Slide 7: Three-H Focus
Three-H Focus Net Income Margin, % per Adjusted Net Income Amphastar’s Management team operates the Company to: 35% ■ Insist on High Quality ■ Emphasize High Efficiency and 30% 27.3% ■ Rely on High Technology to Develop Pipelines 25% Net Income Margin, % 20.7% The 3-H focus results in high net incom
Slide 8: Leveraging Strategic Vision & Core Strengths
Leveraging Strategic Vision & Core Strengths 8
Slide 9: Pipeline Evolution
Pipeline Evolution Amphastar’s pipeline is projected to advance with a greater focus on proprietary and biosimilar products 2021 Pipeline Projected 2026 Pipeline Generic Proprietary 15% 21% Proprietary 50% Generic 63% Biosimilar 16% Biosimilar 35% 9
Slide 10: Technical Platforms
Technical Platforms Characterization Particle Novel Highly-Purified Engineering Formulation Immunogenicity rDNA Novel Device Peptide/Protein Evaluation Insulin Analogs Multiple peptide/protein BLA NDA The Only FDA products including Biosimilar approved asthma AMP-028 Interchangeable inhaler availabl
Slide 11: Strategic Shift Toward Proprietary & Biosimilars Drugs
Strategic Shift Toward Proprietary & Biosimilars Drugs Diabetes Portfolio CapEx Investments & Product Support • 3 Biosimilar Insulins Proprietary Product • GLP-1 ANDA Capacity expansion at Pipeline facilities to support future approvals • Intranasal Commerical In Progress Inhalation Pipeline Epineph
Slide 12: R&D and Pipeline
R&D and Pipeline 12
Slide 13: Focused on R&D Investment
Focused on R&D Investment Self-funded R&D investment of approximately $345 million in the recent 5 years ■ Strategic focus to make substantial R&D investments to expand our product portfolio ■ Diverse pipeline development with flexibility and scalability for sourcing API, starting material, and rese
Slide 14: Pipeline – ANDAs and BLAs with Technical Barriers
Pipeline – ANDAs and BLAs with Technical Barriers Generic Pipeline, 8 Candidates ANDA Type Product Code Current Stage *IQVIA Sales AMP-002 GDUFA Q2 2023, no FDA Action and no pending requests as of 1/10/25 +$500 Million Injectable AMP-015 (Teriparatide) CRL received; planned response in Q1 2025 +$60
Slide 15: Diabetes Portfolio
Diabetes Portfolio Commercialized GLP-1 Interchangeable Insulin Pipeline Glucagon Inj. Kit AMP-018 AMP-004 AMP-005 AMP-025 BAQSIMI® Nasal Powder GLP-1 Insulin Recombinant Insulin ANDA Aspart Human Insulin Degludec ■ BAQSIMI®, the first and only FDA approved glucagon nasal powder ■ The first FDA appr
Slide 16: Sales and Marketing
Sales and Marketing 16
Slide 17: Sales and EPS Trend
OOOO eee Sales and EPS Trend Annual EPS, Adjusted Annual Revenue ($M) 700 oe 644 33 650 ee 3.0 600 aoe 27 550 499 wo >t 5 . = 438 18 S 450 15 vi 400 350 12 350 322 09 0.6 300 a [| 03 250 0.0 2019 2020 2021 2022 2023 2019 2020 2021 2022 2023 Year Year AMPHASTAR 17 Spe sruacevticats
Slide 18: Recent Quarter Trend: Sales & Adjusted EPS
Recent Quarter Trend: Sales & Adjusted EPS 18
Slide 19: Existing Products Provide Strong Base
Existing Products Provide Strong Base New Launches have Supported Diversification of the Revenue Base % of Total Revenue ($210 MM) % of Total Revenue ($644 MM) 5% 14% 9% 22% 3% 4% 2% 5% 7% 6% 51% 8% 13% 9% 18% 11% 14% 2014 2023 ■ Enox. ■ Lidocaine ■ Naloxone ■ Insulin API ■ Enox. ■ Lidocaine ■ Nalox
Slide 20: Key Proprietary Products
Key Proprietary Products 20
Slide 21: BAQSIMI Strategic Rationale: A Transformative Transaction for Amphastar
BAQSIMI® Strategic Rationale: A Transformative Transaction for Amphastar Novel intranasal glucagon product with IP protection Branded product with Expands growing diabetes sales and portfolio strong gross margin BAQSIMI® fits well into Amphastar’s proprietary product Initiate strategy Builds upon co
Slide 22: BAQSIMI Patient Impact
BAQSIMI® Patient Impact BAQSIMI® is currently a category Glucagon is underutilized: leader for ease in patient use: The American Diabetes Association (ADA) recommends that patients at increased risk Simple nasal administration: for Level 2 hypoglycemia be prescribed Currently the only non-injection
Slide 23: BAQSIMI Forecast
BAQSIMI® Forecast ■ Sales − Net Economic Benefit (sales minus expenses) will be BAQSIMI® Worldwide Annual Sales booked until Amphastar takes over distribution from Lilly, 180 on a country by country basis throughout 2024 $153M 160 − Projected to reach peak of $250 million to $275 million $139M 140 ■
Slide 24: Primatene MIST
Primatene MIST® ■ Primatene MIST®, a proprietary and patent- Primatene MIST® Annual Sales protected over-the-counter epinephrine 135 inhalation product 115 ■ Achieved $100mm sales target in 2024(1) $101M ■ The only FDA approved asthma inhaler 95 $84M $89M available OTC, launched Dec 2018 $-Million 7
Slide 25: Highlights and Catalysts
Highlights and Catalysts 25
Slide 26: Growth Drivers and Upcoming Milestones
Growth Drivers and Upcoming Milestones Key Growth Drivers in 2025 ■ BAQSIMI® ■ Expected approvals - Increased sales footprint - AMP-002 CRL responded; GDUFA Q2 2023 ■ Primatene MIST® - AMP-015 (Teriparatide) CRL received, planned - Advertising campaign response Q1 2025 - Increased Physician sampling
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