Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — J.P. Morgan Healthcare Conference 2024
26 slides from Amphastar Pharmaceuticals's conference presentation, January 2024
Slide 1: J.P. Morgan Healthcare Conference
Injectables Biosimilar Inhalation Interchangeable Intranasal Proprietary Complex Highly Purified Generic Peptide/Protein Combination Products J.P. Morgan Healthcare Conference January 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 6° @AMPHASTAR 2
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 3
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 Baqsimi® RextovyTM AFP Analog Armstrong NDA, ANDA, NDA, IN NDA, Highly- rDNA MDI, BLA, Device MDI Facility Powder I
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% 27.6% ■ 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 7
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% 8
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 9
Slide 11: Strategic Shift Toward Proprietary & Biosimilars Drugs
Strategic Shift Toward Proprietary & Biosimilars Drugs Insulin Aspart CapEx Investments & Proprietary Product First insulin Product Support Pipeline product BLA filed Capacity expansion at • Intranasal facilities to support future Epinephrine approvals Commerical Inhalation Pipeline • 3 early stage
Slide 12: R&D and Pipeline
R&D and Pipeline 11
Slide 13: Focused on R&D Investment
Focused on R&D Investment ■ Strategic focus to make substantial R&D Self-funded R&D investment of approximately investments to expand our product portfolio $330 million in the recent 5 years Annual Cost of R & D (% of Revenue) ■ Diverse pipeline development with flexibility 22% 21.4% and scalability
Slide 14: Pipeline – ANDAs with Technical Barriers
Pipeline – ANDAs 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 1/04/24 +$500 Million Injectable AMP-015 (Teriparatide) CRL received and responded; GDUFA Q1 2024 +$600 Million
Slide 15: Diabetes Portfolio
Diabetes Portfolio Commercialized GLP-1 Interchangeable Insulin Pipeline Glucagon Inj. Kit AMP-004 AMP-018 AMP-025 AMP-005 AMP-004m 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
Slide 16: Sales and Marketing
Sales and Marketing 15
Slide 17: Sales and EPS Trend
Sales and EPS Trend Annual EPS, Adjusted 2.1 1.97 1.8 1.5 1.37 $ 1.2 0.9 0.64 0.6 0.36 0.3 0.21 0.0 2018 2019 2020 2021 2022 Year 16
Slide 18: Recent Quarter Trend: Sales & Gross Profit
Recent Quarter Trend: Sales & Gross Profit 17
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 7% 14% 22% 17% 4% 5% 3% 6% 51% 5% 15% 9% 11% 11% 10% 11% 2014 2022 ■ Enox. ■ Lidocaine ■ Naloxone ■ Insulin API ■ Enox. ■ Primatene MIST® ■ Epi ■ Glucagon ■ Vit
Slide 20: Key Proprietary Products
Key Proprietary Products 19
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 BAQSIMI® Worldwide Annual Sales 160 − Projected to reach $145 million to $155 million annualized $139M in 2023 140 − Net Economic Benefit (sales minus expenses) will be 120 $113M booked until Amphastar takes over distribution from Lilly, on a country by country basis throug
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 studie
Slide 25: Highlights and Catalysts
Highlights and Catalysts 24
Slide 26: Growth Drivers and Upcoming Milestones
Growth Drivers and Upcoming Milestones Key Growth Drivers in 2024 ■ BAQSIMI® ■ Expected approvals - Increased promotion - AMP-002 CRL responded; GDUFA Q2 2023 ■ Glucagon Injection Kit - AMP-008 CRL responded; GDUFA Q2 2024 - Increased market opportunity - Increased capacity approved - AMP-015 (Terip
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