Amphastar Pharmaceuticals, Inc. · NASDAQ:AMPH
Amphastar Pharmaceuticals — Investor Presentation (January 2021)
23 slides from Amphastar Pharmaceuticals's investor presentation, Jan 12, 2021
Slide 1: Investor Presentation January 2021
Investor Presentation January 2021 Exhibit 99.1
Slide 2: Forward Looking Statements
1 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 oth
Slide 3: Fully Integrated Business Model
2 ■ Extensive in-house product development capabilities − Strong product development − State-of-the-art instruments − Animal studies − Clinical research team ■ Control over quality and compliance throughout the product development and manufacturing cycle ■ Fully integrated back end manufacturing cap
Slide 4: Company Overview: Amphastar Facilities
3 Company Overview: Amphastar Facilities Vertically integrated from R&D to clinical trials, manufacturing, marketing and distribution
Slide 5: Focus on Products With High Technical Barriers
4 Focus on Products With High Technical Barriers ■ Scarcity of API requires unique synthetic or rDNA capabilities ■ Characterization for complex molecules ■ Immunogenicity studies for proteins and complex molecules ■ Difficult or complex manufacturing processes ■ Proprietary delivery technologies: P
Slide 6: Company Overview: Milestones of Pipeline Development
5 Company Overview: Milestones of Pipeline Development Drug Name Regulatory Indication Description Hyaluronidase NDA→BLA Adjuvant Protein, injectable Enoxaparin ANDA Deep Vein Thrombosis Polysaccharide, injectable, combination product Primatene MIST® NDA Intermittent Asthma Asthma inhaler, OTC, MDI,
Slide 7: Company Overview: Commercial Product Portfolio
6 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 − Gluc
Slide 8: Company Overview: Sales and Gross Profit Trend
7 Company Overview: Sales and Gross Profit Trend $240 $295 $322 $200 $250 $300 $350 2017 2018 2019 ($ millions) Historical Net Revenue Historical Gross Profit $91 $107 $132 $80 $90 $100 $110 $120 $130 $140 2017 2018 2019 ($ millions)
Slide 9: Existing Products Provide Strong Base
8 Enox. 13% 11% 14% 14% 9% 6% 27% 6% Products Net Revenue ($ Millions) 2018 2019 Naloxone $37 $35 Lidocaine $43 $46 Vitamin K1 $42 $46 Enoxaparin $53 $43 Medroxyprogesterone (MPA) $24 $28 Primatene MIST® $4 $18 Other Pharma Products $68 $86 Insulin API $24 $20 Total $295 $322 Existing Products Provi
Slide 10: Focused on R&D Investment
9 ■ Strategic focus to make substantial R&D investments to expand our product portfolio and grow our business ■ Leveraging technical capabilities and/or identify and develop high- margin opportunities ■ We believe our emphasis and investment in R&D differentiates us from our competitors as our focus
Slide 11: Amphastar Nanjing Pharmaceuticals (ANP) Overview
10 ■ Established to provide APIs and starting materials to Amphastar ■ Current portfolio of APIs and starting materials - 4 FDA approvals for Amphastar’s NDA/ANDA - 14 DMFs on file with the FDA for Amphastar’s pipeline candidates - Several additional DMFs in development Amphastar Nanjing Pharmaceuti
Slide 12: Amphastar Nanjing Pharmaceuticals (ANP) Development
11 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
Slide 13: Pipeline – ANDA with Technical Barriers
12 Pipeline – ANDA with Technical Barriers ■ Three Injectable ANDAs in development targeting products with IQVIA sales of approximately $3 Billion ■ Five Inhalation ANDAs in development targeting products with IQVIA sales of approximately $8 Billion ■ Most of them with technical barriers ■ Technical
Slide 14: Pipeline – Insulin and Proteins, Biologics License Applications (BLAs)
13 Pipeline – Insulin and Proteins, Biologics License Applications (BLAs) ■ Three candidates of Insulins (“Insulin Program”) and Proteins ■ Significant US market: IQVIA sales ~$13 Billion, ~130 millions of units ■ Need sophisticated rDNA technology, state-of-the-art analytical technology, and signif
Slide 15: Pipeline – Insulin and Proteins, BLAs
14 Pipeline – Insulin and Proteins, BLAs ■ 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 “unnecessary” ■ API Manufacturing: rDNA technology, by
Slide 16: Pipeline – Proprietary Pipeline, New Drug Applications (NDAs)
15 Pipeline – Proprietary Pipeline, New Drug Applications (NDAs) Proprietary Pipeline NDA ■ 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 exp
Slide 17: Glucagon for Injection Kit Launch
16 ■ The first and only FDA approved generic Glucagon for Injection in 20 years ■ Highly-purified synthetic peptide product was determined by FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit, which has recombinant DNA (rDNA) origin ■ Highlights the Company
Slide 18: Primatene MIST History
17 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 ■ Intensive cardiovascular studies >40,000 data points ■ Special label
Slide 19: Primatene MIST Marketing Update
18 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
Slide 20: Primatene MIST: Sales Trend
19 Primatene MIST®: Sales Trend
Slide 21: Near-Term Growth Points in 2021
20 Near-Term Growth Points in 2021 Glucagon Injection Kit launch planned 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 2
Slide 22: Strong Balance Sheet
21 Strong Balance Sheet ($ 000s) Cash, cash equivalents, restricted cash and short-term investments $102,848 Long-term debt, including current portion $45,070 Total stockholders’ equity $450,962 Capitalization as of September 30, 2020
Slide 23: Investment Highlights
22 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 $322 million in 2019 revenue and approximately $132 million i
Amphastar Pharmaceuticals — Investor Presentation (January 2021) on 6ix