Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — Investor Presentation (February 2023)
27 slides from Amphastar Pharmaceuticals's investor presentation, February 2023
Slide 1: Corporate Presentation
Injectables Proprietary Biosimilars Inhalation Complex Generic Corporate Presentation February 2023
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements that are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements include all statements other
Slide 3: Company Framework
Company Framework 2
Slide 4: Fully Integrated Business Model
Fully Integrated Business Model ■ Extensive in-house product Product Development development capabilities − Strong product development − State-of-the-art instruments API / Key − Animal studies Components − Clinical research team Manufacturing ■ Control over US Based Finished quality and compliance ■
Slide 5: Focus on Products With High Technical Barriers
Focus on Products With High Technical Barriers High Technical Barriers to Entry Products with: • Large markets ■ Scarcity of API requires unique synthetic or rDNA capabilities • High technical ■ Characterization for complex molecules barriers to entry ■ Immunogenicity studies for proteins and comple
Slide 6: Amphastar Facilities
Amphastar Facilities Vertically integrated from R&D to clinical trials, manufacturing, marketing, and distribution 5
Slide 7: Milestones of Pipeline Development
Milestones of Pipeline Development ANDAs: 10 ■ Filed: 3 ■ Pending Launch: 1 ■ In Development: ■ Key: - 2 Injectable ■ Key: Highly purified peptide - 4 Inhalation Proprietary Formulation ■ Regulatory Pathway: Insulin Biosimilar: 3 ■ Regulatory Pathway: ANDA NDAs: 5 ■ Key: NDA ■ Indication: Complex Ge
Slide 8: Commercial Product Portfolio
Commercial Product Portfolio ■ Diverse core of over 20 commercial products ■ Injectable and MDI products; including complex, combination products ■ Consistent revenue and cash flow ■ Indications include: deep vein thrombosis, asthma, opioid overdose, pain management, anesthesia, and hypoglycemia − E
Slide 9: Sales and Marketing
Sales and Marketing 8
Slide 10: Sales and Gross Profit Annual Trend
Sales and Gross Profit Annual Trend 9
Slide 11: Margin Rate and Adjusted EPS Annual Trend
Margin Rate and Adjusted EPS Annual Trend Annual Gross Profit Margin Annual EPS, Adjusted 55% 2.1 1.97 49.9% 50% 1.8 Gross Profit Margin 45.7% 1.5 1.37 $ 45% 1.2 40.9% 41.0% 40% 0.9 0.64 36.3% 0.6 0.36 35% 0.21 0.3 0.0 30% 2018 2019 2020 2021 2022 2018 2019 2020 2021 2022 Year Year 10
Slide 12: Recent Quarter Trend: Sales & Gross Profit
Recent Quarter Trend: Sales & Gross Profit 11
Slide 13: Existing Products Provide Strong Base Diversified Revenue
Existing Products Provide Strong Base Diversified 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 ■ Vita K ■ Epi ■ Other Pharma ■ Lidocaine ■ Vita K ■ Naloxone ■ Insulin API ■ Other Pha
Slide 14: 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 15: Primatene MIST Sales Trend: In-Store Weekly Sales in Units
Primatene MIST® Sales Trend: In-Store Weekly Sales in UNITS Primatene MIST® sales target of $100 Million in 2024 14
Slide 16: R&D and Pipeline
R&D and Pipeline 15
Slide 17: 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 18: Amphastar Nanjing Pharmaceuticals (ANP) Overview
Amphastar Nanjing Pharmaceuticals (ANP) Overview ■ Established to provide APIs and starting materials to Amphastar ■ Current portfolio of APIs and starting materials - 4 FDA approvals for Amphastar’s NDAs/ANDAs - 17 DMFs on file with the FDA for Amphastar’s pipeline candidates - Several additional D
Slide 19: Pipeline – ANDAs with Technical Barriers
Pipeline – ANDAs with Technical Barriers Generic Pipeline, 10 Candidates with Technical Barriers ■ Technical platforms to be used: Characterization of complex molecules, immunogenicity, peptide and protein product development and production, particle engineering, sustained-release and novel formulat
Slide 20: Diabetes Portfolio
Diabetes Portfolio Commercialized Interchangeable Insulin Pipeline AMP-004 Glucagon AMP-003 AMP-005 AMP-004m Insulin Insulin Recombinant Glargine Aspart Human Insulin ■ First and only FDA approved generic Glucagon ■ Covers the full spectrum of the insulin from rapid to long acting ■ AMP-004 BLA plan
Slide 21: Diabetes Portfolio Cont.
Diabetes Portfolio Cont. Amphastar Factors in Achieving Interchangeability: ■ Demonstrated technological platform to achieve high-purity - Proven with Hyaluronidase, Enoxaparin and Glucagon approvals ■ Company’s sophisticated characterization technology and achievements of highly – purified peptides
Slide 22: Current Regulatory Pathways for Interchangeable Biosimilar Insulin
Current Regulatory Pathways for Interchangeable Biosimilar Insulin Regulatory Strategy for Insulin Products: Interchangeability A. FDA regulatory pathway for recently approved product Further rDNA API 351 (k) Studies Significant Clinical Studies Biosimilar Interchangeable Characterization B. A
Slide 23: Pipeline – Proprietary Pipeline, New Drug Applications (NDAs)
Pipeline – Proprietary Pipeline, New Drug Applications (NDAs) Developed under Amphastar: A platform of proven R&D and technological strengths AMP-012 Intranasal Naloxone • Refiled September 2022; PDUFA Q1 2023 AMP-019 Intranasal Epinephrine • Patent pending • Planned NDA filing in 2024 ■ Three early
Slide 24: Pipeline Evolution
Pipeline Evolution Amphastar’s pipeline projected to advance with more focus on proprietary and biosimilar products 2021 Pipeline Projected 2025 Pipeline Generic Proprietary 15% 21% Proprietary 50% Generic 63% Biosimilar 16% Biosimilar 35% 23
Slide 25: Highlights and Catalysts
Highlights and Catalysts 24
Slide 26: Strong Balance Sheet
Strong Balance Sheet Capitalization as of December 31, 2022 ($ 000s) Cash, cash equivalents, restricted cash, and short-term investments $178,197 Long-term debt, including current portion $75,885 Total stockholders’ equity $528,658 25
Slide 27: Growth Drivers in 2023 and Upcoming Milestones
Growth Drivers in 2023 and Upcoming Milestones Key Growth Drivers in 2023 ■ Glucagon Injection Kit ■ Primatene MIST® - Strong sales since launched in Feb. 2021 - Nationwide TV, Radio and Digital Advertising - Increased market opportunity driving weekly sales - Increased capacity approved - Physician
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