Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — Piper Sandler 33rd Annual Virtual Healthcare Conference 2021
26 slides from Amphastar Pharmaceuticals's conference presentation, November 2021
Slide 1: Piper Sandler 33rd Annual Virtual Healthcare Conference
Injectables Proprietary Biosimilars Inhalation Complex Generic Piper Sandler 33rd Annual Virtual Healthcare Conference November 2021
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: 13 ■ Filed: 5 ■ In Development: ■ Key: - 3 Injectable ■ Key: Highly purified peptide - 5 Inhalation Proprietary Formulation ■ Regulatory Pathway: Insulin Biosimilar: 3 ■ Regulatory Pathway: ANDA NDAs: 4 ■ Key: NDA ■ Indication: Complex Generic Hypoglycemia ■
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 Trend
Sales and Gross Profit Trend Annual Revenue ($M) Annual Gross Profit ($M) 450 200 205 429 400 175 350 350 322 150 143 $, Millions $, Millions 295 132 300 125 250 240 107 100 91 200 75 150 100 50 2017 2018 2019 2020 2021E* 2017 2018 2019 2020 2021E* Year Year * Based on consensus estimates 9
Slide 11: Recent Quarter Trend: Sales & Net Profit
Recent Quarter Trend: Sales & Net Profit Recent Quarterly Revenue ($M) Recent Quarterly: EPS ($) 125 0.6 120 0.59 0.5 115 112 110 0.21* 0.4 105 103 102 $ Millions 100 0.3 $ per Share 96 95 0.38 0.2 0.16 90 85 83 0.10 0.1 0.08 80 75 0.0 Q3 Q4 Q1 Q2 Q3 2020 Q3 2020 Q4 2021 Q1 2021 Q2 2021 Q3 2020 2021
Slide 12: Existing Products Provide Strong Base Diversified Revenue
Existing Products Provide Strong Base Diversified Revenue 9% 14% 21% 4% 16% 5% 5% 6% 51% 7% 12% 9% 10% 11% 10% 2021 YTD 10% 2014 ■ Enox. ■ Lidocaine ■ Naloxone ■ Insulin API ■ Enox. ■ Primatene MIST® ■ Epi ■ Lidocaine ■ Vita K ■ Epi ■ Other Pharma ■ Vita K ■ Glucagon ■ Naloxone ■ Insulin API ■ Other
Slide 13: 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 14: Primatene MIST Sales Trend: In-Store Weekly Sales in Units
Primatene MIST® Sales Trend: In-Store Weekly Sales in UNITS Primatene MIST® sales on track to reach >$65m in 2021 13
Slide 15: R&D and Pipeline
R&D and Pipeline 14
Slide 16: 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 $280 million in the recent 5 years Annual Cost of R & D (% of Revenue) ■ Diverse pipeline development with flexibility 22% 21% and scalability f
Slide 17: 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 18: Pipeline – ANDAs with Technical Barriers
Pipeline – ANDAs with Technical Barriers Generic Pipeline, 13 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 19: Diabetes Portfolio
Diabetes Portfolio Commercialized Interchangeable Insulin Pipeline Glucagon AMP-003 AMP-004 AMP-005 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 ■ First IND has been filed
Slide 20: 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 21: Current Regulatory Pathways for Interchangeable Biosimilar Insulin
Current Regulatory Pathways for Interchangeable Biosimilar Insulin Regulatory Strategy for Insulin Products: Interchangeability A. Recently approved FDA regulatory pathway Further rDNA API 351 (k) Studies Significant Clinical Studies Biosimilar Interchangeable Characterization B. Amphastar reg
Slide 22: 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 • Target refiling Q1 2022 AMP-019 Intranasal Epinephrine • Clinical studies progressing well, phase I complete • Patent Pending ■
Slide 23: Pipeline Evolution
Pipeline Evolution Amphastar’s pipeline projected to advance with more focus on proprietary and biosimilar products Current 2025 Projected Generic Proprietary 15% 21% Proprietary 50% Generic 63% Biosimilar 16% Biosimilar 35% 22
Slide 24: Highlights and Catalysts
Highlights and Catalysts 23
Slide 25: Strong Balance Sheet
Strong Balance Sheet Capitalization as of September 30, 2021 ($ 000s) Cash, cash equivalents, restricted cash, and short-term investments $117,066 Long-term debt, including current portion $77,808 Total stockholders’ equity $430,176 Long-term debt as a percentage of total equity 8.2% 24
Slide 26: Growth Drivers in 2021 and Upcoming Milestones
Growth Drivers in 2021 and Upcoming Milestones Key Growth Drivers in 2021 ■ Glucagon Injection Kit ■ Primatene MIST® - Strong sales since launched in Feb. 2021 - Nationwide TV, Radio and Digital Advertising ■ Epinephrine multi-dose vials driving weekly sales - Strong year-over-year sales growth - Ph
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