Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — 36th Annual Piper Sandler Healthcare Conference (December 2024)
26 slides from Amphastar Pharmaceuticals's conference presentation, Dec 4, 2024
Slide 1: 36th Annual Piper Sandler Healthcare Conference
Injectables Biosimilar Inhalation Interchangeable Intranasal Proprietary Complex Highly Purified Generic Peptide/Protein Combination 36th Annual Piper Sandler Products Healthcare Conference December 4th, 2024
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 RextovyTM Insulin AFP Baqsimi® Analog Armstrong NDA, ANDA, NDA, Highly- NDA, IN BLA, MDI Facility rDNA Powder IN MDI, Devic
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 2025 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 BLA NDA The Only FDA Biosimilar approved asthma ANDA Interchangeable inhaler available as ANDA NDA-Intranasal OTC Delivery 10
Slide 11: Strategic Shift Toward Proprietary & Biosimilars Drugs
Strategic Shift Toward Proprietary & Biosimilars Drugs CapEx Investments & Proprietary Product Product Support Pipeline Insulin Aspart Capacity expansion at • Intranasal facilities to support future Epinephrine Commerical approvals • 3 early stage Capabilities Inhalation Pipeline products Expanded (
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 11/14/24 +$500 Million Injectable AMP-015 (Teriparatide) CRL received; planned response in Q4 2024 +$6
Slide 15: Diabetes Portfolio
Diabetes Portfolio Commercialized GLP-1 Interchangeable Insulin Pipeline Glucagon Inj. Kit AMP-018 AMP-025 AMP-004 AMP-005 BAQSIMI® Nasal Powder GLP-1 Insulin Insulin Recombinant ANDA Degludec Aspart Human Insulin ■ BAQSIMI®, the first and only FDA approved glucagon nasal powder ■ First and only FDA
Slide 16: Sales and Marketing
Sales and Marketing 16
Slide 17: Sales and EPS Trend
sss Sales and EPS Trend 700 650 600 550 500 450 400 350 300 250 S, Millions AMPHASTAR Spe rsrmacevticats Annual Revenue ($M) 499 438 350 322 Ll 644 | | 2019 2020 2021 Year 2022 2023 3.3 3.0 27 24 2.1 18 15 1.2 0.9 0.6 0.3 0.0 Annual EPS, Adjusted 2019 2020 2021 2022 # 2023 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 % of Total Revenue 5% 14% 8% 22% 4% 14% 5% 2% 6% 51% 3% 9% 9% 13% 7% 11% 18% 2014 2023 ■ Enox. ■ Lidocaine ■ Naloxone ■ Insulin API ■ Enox. ■ Primatene MIST® ■ Epi ■ Glucagon ■ Vi
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 BAQSIMI® Worldwide Annual Sales 180 ■ Sales $153M 160 − Net Economic Benefit (sales minus expenses) will be $139M booked until Amphastar takes over distribution from Lilly, 140 on a country by country basis throughout 2024 120 $113M − Projected to reach peak of $250 million to $275
Slide 24: Primatene MIST
Primatene MIST® ■ Primatene MIST®, a proprietary and patent-protected over-the-counter epinephrine inhalation product ■ The only FDA approved asthma inhaler available OTC, launched Dec 2018 ■ Multiple scientific articles were published in support of Primatene MIST® ■ Intensive cardiovascular studies
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 ■ Glucagon Injection Kit - AMP-015 (Teriparatide) CRL received - Increased market opportunity - AMP-007 Launched in Canada - AMP-018
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