Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — Investor Presentation (August 2021)
24 slides from Amphastar Pharmaceuticals's investor presentation, Aug 26, 2021
Slide 1: Corporate Presentation
Corporate Presentation August 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: Fully Integrated Business Model
Fully Integrated Business Model ■ Extensive in-house product Product development capabilities Development − Strong product development State-of-the-art instruments − − Animal studies API /Key ■ Control over − Clinical research team Components quality and Manufacturing compliance throughout ■ Fully i
Slide 4: Company Overview: Amphastar Facilities
Company Overview: Amphastar Facilities Vertically integrated from R&D to clinical trials, manufacturing, marketing, and distribution 3
Slide 5: Focus on Products With High Technical Barriers
Focus on Products With High Technical Barriers High Technical Barriers to Entry Products with: ■ Scarcity of API requires unique synthetic or • Large markets rDNA capabilities • High technical ■ Characterization for complex molecules barriers to entry ■ Immunogenicity studies for proteins and Focuse
Slide 6: Milestones of Pipeline Development
Milestones of Pipeline Development Pipeline ANDAs -12 ■ Filed-5 ■ Regulatory ■ In Development: Pathway: ANDA • 2 Injectable ■ Indication: • 5 Inhalation ■ Regulatory Hypoglycemia Pathway: NDA Insulin Biosimilar-3 ■ Description: NDAs-4 ■ Regulatory - Highly purified ■ Indication: Pathway: ANDA Interm
Slide 7: Company Overview: Commercial Product Portfolio
Company Overview: Commercial Product Portfolio ■ Diverse core of over 20 commercial products ■ Injectable and MDI products; including complex, combination products ■ Indications include: deep vein thrombosis, asthma, opioid overdose, pain management, anesthesia, and hypoglycemia − Enoxaparin − Prima
Slide 8: Company Overview: Sales and Gross Profit Trend
Company Overview: Sales and Gross Profit Trend Historical Net Revenue Historical Gross Profit ($ millions) ($ millions) $400 $160 $150 $143 $350 $350 $140 $132 $322 $130 $300 $295 $120 $110 $107 $250 $240 $100 $91 $90 $200 $80 2017 2018 2019 2020 2017 2018 2019 2020 7
Slide 9: Existing Products Provide Strong Base
Existing Products Provide Strong Base Net Revenue Diversified Revenue Products ($ Millions) 18% 2019 2020 5% Primatene MIST® $18 $52 2014 51% 11% Enoxaparin $43 $49 9% 6% Vitamin K1 $46 $43 Enox. Naloxone Lidocaine Vita K Insulin API Other Pharma Lidocaine $46 $41 Naloxone $35 $33 Epinephrine $14 $2
Slide 10: Focused on R & D Investment
Focused on R & D Investment ■ Strategic focus to make substantial Self-funded R&D investment of R&D investments to expand our approximately $280 million in the product portfolio and grow our recent 5 years business ($ millions) ■ Leveraging technical capabilities $70 $69 $67 and/or identify and deve
Slide 11: 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 NDA/ANDA - 17 DMFs on file with the FDA for Amphastar’s pipeline candidates - Several additional DMF
Slide 12: Amphastar Nanjing Pharmaceuticals (ANP) Development
Amphastar Nanjing Pharmaceuticals (ANP) Development ■ Sold 42% of ANP ownership for $57 million in 2018 to fund: - ANP’s API facility, including rDNA products - Manufacturing and selling API and finished product to the China market ■ Planned repurchase of 26% from ANP from external investors for $29
Slide 13: Pipeline – ANDA with Technical Barriers
Pipeline – ANDA with Technical Barriers Generic Pipeline, 12 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 formulati
Slide 14: Pipeline – Insulin and Proteins, Biologics License Applications (BLAs)
Pipeline – Insulin and Proteins, Biologics License Applications (BLAs) Insulins and Proteins, Biosimilar and/or Interchangeable ■ Three candidates of insulins (“Insulin Program”) and proteins ■ Significant US market: IQVIA sales ~$13 Billion, ~130 millions of units ■ Need sophisticated rDNA technolo
Slide 15: Pipeline – Insulin and Proteins, BLAs
Pipeline – Insulin and Proteins, BLAs Insulins and Proteins, Biosimilar and/or Interchangeable ■ FDA Guidance established regulatory route by analytical assessment based on state-of-the-art technology supports a demonstration of “highly similar” and heavy clinical study for immunogenicity would be “
Slide 16: Regulatory Strategy for Insulin Products: Interchangeability
Pipeline – Insulin and Proteins, BLAs Regulatory Strategy for Insulin Products: Interchangeability Further rDNA API 351(k) Studies A. Heavy Clinical Studies Biosimilar Interchangeable Characterization rDNA API, High-purified 351(k) Biosimilar B. BE Clinical Studies Interchangeable Extended Character
Slide 17: Pipeline – Proprietary Pipeline, New Drug Applications (NDAs)
Pipeline – Proprietary Pipeline, New Drug Applications (NDAs) Proprietary Pipeline NDA ■ The development of innovative proprietary products requires sophisticated technology ■ Amphastar’s proven R&D, and technical platforms support the development of proprietary pipeline candidates ■ Amphastar has e
Slide 18: Glucagon for Injection Kit Launch
Glucagon for Injection Kit Launch ■ The first and only FDA approved generic Glucagon for Injection in 20 years ■ FDA determined that our highly-purified synthetic peptide product to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit, which has recombinant DNA (rDNA
Slide 19: Primatene MIST History
Primatene MIST® History ■ Primatene MIST®, a proprietary and patent-protected over- the-counter epinephrine inhalation product ■ The only FDA approved asthma inhaler available OTC ■ Purchased U.S. trademark from Wyeth in 2008 ■ Amphastar reformulated Primatene from CFC to HFA ■ Intensive cardiovascu
Slide 20: Primatene MIST Marketing Update
Primatene MIST® Marketing Update ■ Improvements from Primatene MIST ® CFC − Higher delivery efficiency, with improved efficacy at a lower dose − Dose indicator − Aluminum container instead of glass − HFA propellant replaces CFC ■ Effective TV and Radio advertising campaign began in July 2019 with na
Slide 21: Primatene MIST: Sales Trend
Primatene MIST®: Sales Trend 20
Slide 22: Growth Drivers in 2021
Growth Drivers in 2021 Glucagon Injection Kit launched February 2021 Primatene MIST® indicated for “intermittent asthma” - Adult asthma patients: 19.2 million per CDC* - Intermittent adult asthma patients: ~35% (per CDC**), or 6.7 million Epinephrine multi-dose vials launched May 2020 *https://www.c
Slide 23: Strong Balance Sheet
Strong Balance Sheet Capitalization as of December 31, 2020 ($ 000s) Cash, cash equivalents, restricted cash, and short-term $109,684 investments Long-term debt, including current portion $46,449 Total stockholders’ equity $448,723 22
Slide 24: Investment Highlights
Investment Highlights ■ Biopharmaceutical company focused on development and manufacturing of technically- challenging BLAs, NDAs, and ANDAs in injectable, inhalable, and intranasal formulations ■ Strong base business with approximately $350 million in 2020 revenue and approximately $143 million in
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