Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — Investor Presentation (May 2025)
26 slides from Amphastar Pharmaceuticals's investor presentation, May 2025
Slide 1: Corporate Presentation
Injectables Biosimilar Inhalation Interchangeable Intranasal Proprietary Complex Highly Purified Generic Peptide/Protein Combination Corporate Presentation Products May 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: Adjusted Net Income Margin
Three-H Focus Amphastar’s Management team operates the Company to: Adjusted Net Income Margin, % ■ Insist on High Quality 35% ■ Emphasize High Efficiency and ■ Rely on High Technology to Develop Pipelines 30% 27.3% 27.4% The 3-H focus results in high net income margin 25% Adjusted Net Income Margin,
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 Expected Approvals CapEx Investments & Product Support AMP-002 Proprietary Product AMP-015 Capacity expansion at Pipeline facilities to support future AMP-007 approvals • Intranasal AMP-018 (GLP-1) Inhalation Pipeline Epinephrine In Progress (Co
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 $351 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, 7 Candidates ANDA Type Product Code Current Stage *IQVIA Sales AMP-002 GDUFA Q2 2023, No pending requests as of 5/5/25 +$500 Million Injectable AMP-015 (Teriparatide) GDUFA 4Q 2025 +$500 Million AMP-018 (GLP-1) CRL Received; Planned
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
sss Sales and EPS Trend S, Millions = AMPHASTAR PHARMACEUTICALS 800 750 700 650 600 550 500 450 400 350 300 250 200 150 100 Annual Revenue 2020 2021 2022 2023 2024 Year S Per Share 0.64 Annual EPS, Adjusted 2020 2021 2022 2023 2024 Year 17
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 ($732 MM) 3% 15% 8% 14% 2% 1% 4% 3% 6% 5% 6% 51% 13% 20% 9% 14% 11% 2014 2024 15% ■ Enox. ■ Lidocaine ■ Naloxone ■ Insulin API ■ Enox. ■ Lidocaine ■ N
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 − Projected to reach peak of $250 million to $275 BAQSIMI® Worldwide Annual Sales million 200 180 $166M ■ Selling Expense $153M 160 − Projected to be 15% of Baqsimi® sales $139M 140 − Starting in January 2025: Collaboration with 120 $113M $-Million Mannkind to increase Baqs
Slide 24: Primatene MIST
Primatene MIST® ■ Primatene MIST®, a proprietary and patent- Primatene MIST® Annual Sales protected over-the-counter epinephrine 115 inhalation product 105 $102M ■ Surpassed $100mm sales target in 2024 95 $84M $89M 85 ■ The only FDA approved asthma inhaler $73M 75 available OTC, launched Dec 2018 $-
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 GDUFA 2Q 2023; No pending FDA ■ Primatene MIST® requests - Advertising campaign - AMP-015 (Teriparatide) GDUFA 4Q 2025 - Increased physician sampling program - AMP-
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