Slides
Page 1
J. P. Morgan Healthcare Conference January 2025 Highly Purified Peptide/Protein Proprietary Injectables Inhalation Intranasal Biosimilar Interchangeable Complex Generic Combination Products
Page 2
2 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 management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including, but not limited to, information concerning our business plans and objectives, potential growth opportunities, product development, regulatory approvals, market potential, efficiencies, competitive position, and industry environment, among other statements. All statements in this presentation referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the benefits of the acquisition of BAQSIMI®, including its potential for continued revenue growth, the success of our integration of BAQSIMI®, the transition of our pipeline towards branded products, proprietary products, and biosimilars, our ability to leverage our existing expertise and technology, and other future events. These statements are not facts but rather are based on Amphastar’s historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 29, 2024, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 10, 2024, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 9, 2024, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 7, 2024. In particular, there can be no guarantee that our pivoting towards high-value and high- growth areas market will be successful, that demand will be sufficient for us to meet our sales goal for Primatene MIST® or that we will continue to experience significant sales of BAQSIMI®. You can locate these reports through our website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. The forward-looking statements in this presentation speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. The forward-looking statements in this presentation speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur as forward-looking statements are inherently susceptible to uncertainty and changes in circumstances as with any projections or forecasts. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. Any forward-looking statements made by us in this presentation speak only as of the date of this presentation, and we undertake no obligation to update any forward-looking statements for any reason after the date of this presentation, except as required by law. All third-party brand names and logos appearing in this presentation are trademarks or registered trademarks of their respective holders. Any such appearance does not necessarily imply any endorsement of the company.
Page 3
3 Company Overview
Page 4
4 Company Overview ■ High Quality ■ High Efficiency ■ High Technology ■ Pipeline Development ■ Strategic Acquisitions ■ Fully Integrated Business Model, R&D, Manufacturing and Distribution One- Stop Dual Strategies Growth Model Three-H Focus
Page 5
5 ■ Extensive in-house product development capabilities − Technical Platforms − 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 capabilities − API and key materials − Device and key components ■ Complete front-end integration − Marketing − Distribution Fully Integrated Business Model: One-Stop Product Development API / Key Components Manufacturing US Based Finished Product Manufacturing Marketing Distribution
Page 6
6 Dual-Strategies Growth Model Dual-Strategies Pipeline Development Primatene MIST® NDA, MDI, OTC Glucagon Injection ANDA, Highly- Purified Peptide IN NDAs Insulin Analog BLA, rDNA Strategic Acquisition Armstrong MDI Facility AFP rDNA Facility Baqsimi® NDA, Powder IN Delivery Primary - Organic Growth Secondary - Inorganic Growth 2018 2020 On-going 2003 2014 2023On-going
Page 7
7 Three-H Focus Amphastar’s Management team operates the Company to: ■ Insist on High Quality ■ Emphasize High Efficiency and ■ Rely on High Technology to Develop Pipelines The 3-H focus results in high net income margin 3.5% 5.5% 9.0% 15.5% 20.7% 27.3% 0% 5% 10% 15% 20% 25% 30% 35% 2018 2019 2020 2021 2022 2023 Net Income Margin, % Year Net Income Margin, % per Adjusted Net Income ($Million or Specified) 2018 2019 2020 2021 2022 2023 Revenue, x 295 322 350 438 499 644 Net Income (GAAP) -5.7 48.9 1.4 62.1 91.4 137.5 Net Income, Adjusted, y 10.4 17.8 31.6 68.0 103.2 175.7 Net Income Margin, Adjusted, =y/x, % 3.5% 5.5% 9.0% 15.5% 20.7% 27.3%
Page 8
8 Leveraging Strategic Vision & Core Strengths
Page 9
9 Pipeline Evolution Generic 63% Biosimilar 16% Proprietary 21% Generic 15% Biosimilar 35% Proprietary 50% 2021 Pipeline Projected 2026 Pipeline Amphastar’s pipeline is projected to advance with a greater focus on proprietary and biosimilar products
Page 10
10 Technical Platforms NDA The Only FDA approved asthma inhaler available as OTC Multiple peptide/protein products including AMP-028 Insulin Analogs BLA Biosimilar Interchangeable ANDA Baqsimi® Characterization Immunogenicity Evaluation rDNA Highly-Purified Peptide/Protein Particle Engineering Novel Formulation Novel Device
Page 11
11 In ProgressIn Progress In Progress Strategic Shift Toward Proprietary & Biosimilars Drugs Diabetes Portfolio BAQSIMI® acquired with global footprint in +26 countries Commerical Capabilities Expanded • AMP-028 Biosimilar Portfolio Capacity expansion at facilities to support future approvals CapEx Investments & Product Support Proprietary Product Pipeline • Intranasal Epinephrine • 3 early stage products • Primatene MIST® with Green* propellant AMP-002 AMP-015 AMP-007 AMP-018 (GLP-1) Expected Approvals Inhalation pipeline to be filed and approved Inhalation Pipeline (Complex Generic) In Progress In Progress 2023 • 3 Biosimilar Insulins • GLP-1 ANDA In Progress *Low global warming potential
Page 12
12 R&D and Pipeline
Page 13
13 ■ Strategic focus to make substantial R&D investments to expand our product portfolio ■ Diverse pipeline development with flexibility and scalability for sourcing API, starting material, and research under our vertically –integrated platform ■ Emphasis and investment in R&D differentiates us from our competitors as our focus is on the long-term growth of our company ■ R&D from API, early stage, and clinical trials and from laboratory to scale-up Focused on R&D Investment Self-funded R&D investment of approximately $345 million in the recent 5 years
Page 14
14 Pipeline – ANDAs and BLAs with Technical Barriers Generic Pipeline, 8 Candidates *IQVIA sales with TTM as of September 30, 2024 ANDA Type Product Code Current Stage *IQVIA Sales Injectable AMP-002 GDUFA Q2 2023, no FDA Action and no pending requests as of 1/10/25 +$500 Million AMP-015 (Teriparatide) CRL received; planned response in Q1 2025 +$600 Million AMP-018 (GLP-1) Filed, GDUFA Q2 2025 +$1.1 Billion Inhalation AMP-007 Filed, GDUFA extended to Q2 2025 +$2.5 Billion AMP-016 Development AMP-017 Planned filing 2025 AMP-023 Development Biosimilar AMP-028 Development +2.0 Billion
Page 15
15 Diabetes Portfolio Interchangeable Insulin Pipeline Recombinant Human Insulin Insulin Aspart Insulin Degludec AMP-025 AMP-005 AMP-004 ■ BAQSIMI®, the first and only FDA approved glucagon nasal powder ■ The first FDA approved generic Glucagon injection kit ■ GLP-1 ANDA filed ■ Insulin Pipeline: - Covers the full spectrum of the insulin from rapid to long acting - AMP-004 BLA resubmitted Q4 2024 - $6 Billion in IQVIA sales, ~70 million units of both pens and vials Commercialized Glucagon Inj. Kit BAQSIMI® Nasal Powder GLP-1 AMP-018 GLP-1 ANDA *IQVIA sales with TTM as of September 30, 2024
Page 16
16 Sales and Marketing
Page 17
17 Sales and EPS Trend
Page 18
18 Recent Quarter Trend: Sales & Adjusted EPS
Page 19
19 5% 9% 3% 2% 7% 13% 14% 18% 8% 22% 51% 11% 9% 6% 5% 4% 14% 2014 ■ Naloxone ■ Other Pharma ■ Primatene MIST■ Epi■ Vita K ■ Lidocaine■ Enox. Existing Products Provide Strong Base New Launches have Supported Diversification of the Revenue Base 2023 ® ■ Insulin API ■ Enox. ■ Lidocaine ■ Glucagon ■ Naloxone ■ Insulin API ■ Epi ■ Vita K % of Total Revenue ($210 MM) % of Total Revenue ($644 MM) ■ Other Pharma■ Baqsimi®
Page 20
20 Key Proprietary Products
Page 21
21 BAQSIMI® Strategic Rationale: A Transformative Transaction for Amphastar BAQSIMI® fits well into Amphastar’s proprietary product strategy Novel intranasal glucagon product with IP protection Expands diabetes portfolio Builds upon our commercial intranasal product portfolioExpands Amphastar’s international footprint into 26 countries Initiate commercial sales team for BAQSIMI® and future branded products Branded product with growing sales and strong gross margin
Page 22
22 BAQSIMI® Patient Impact Glucagon is underutilized: The American Diabetes Association (ADA) recommends that patients at increased risk for Level 2 hypoglycemia be prescribed glucagon1 Approximately 7 million people are treated with insulin and only about 0.7 million (~10%)2 of these patients currently utilize glucagon BAQSIMI® is currently a category leader for ease in patient use: Simple nasal administration: Currently the only non-injection glucagon approved by the FDA, passively absorbed in the nose, provide lower barrier for administration than injection Ready-to-use with no reconstitution or priming required Smaller product size than other glucagon products, and wider temperature storage range than other glucagon injection product. 1American Diabetes Association. Standards of Medical Care in Diabetes—2020. Diabetes Care. 2020;43(suppl 1):S1-S212. 2Estimates based on IQVIA Annual TRx volume in 2022. Portability for Consumers: Amphastar will focus on BAQSIMI® to better serve patients
Page 23
23 $76M $113M $139M $153M 0 20 40 60 80 100 120 140 160 180 2020 2021 2022 2023 $-Million BAQSIMI® Worldwide Annual Sales BAQSIMI® Forecast ■ Sales − Net Economic Benefit (sales minus expenses) will be booked until Amphastar takes over distribution from Lilly, on a country by country basis throughout 2024 − Projected to reach peak of $250 million to $275 million ■ Selling Expense − Projected to be 15% of Baqsimi® sales − Starting in January 2025: Collaboration with Mannkind to increase Baqsimi® sales footprint with their endocrinology focused sales force ■ Adjusted EPS(1) − Project $2.00 to $2.50 incremental adjusted EPS at peak (1) Adjusted EPS is a non-GAAP financial measure. Reconciliation to the nearest GAAP measure is unavailable without unreasonable efforts. Refer to the section titled "Non-GAAP Financial Measures" for an explanation of non-GAAP financial measures.
Page 24
24 Primatene MIST® ■ Primatene MIST®, a proprietary and patent- protected over-the-counter epinephrine inhalation product ■ Achieved $100mm sales target in 2024(1) ■ The only FDA approved asthma inhaler available OTC, launched Dec 2018 ■ US Adult asthma patients: 20 million per CDC(2) ■ Starting in January 2025: increase physician sampling program ■ Development of proprietary Green(3) propellant formulation with patent pending 1. Based on unaudited results 2. https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm 3. Low global warming potential $18M $52M $73M $84M $89M $101M 15 35 55 75 95 115 135 2019 2020 2021 2022 2023 2024 $-Million Primatene MIST® Annual Sales (1)
Page 25
25 Highlights and Catalysts
Page 26
26 Growth Drivers and Upcoming Milestones ■ BAQSIMI® - Increased sales footprint ■ Primatene MIST® - Advertising campaign - Increased Physician sampling program ■ Albuterol - Launched in August 2024 ■ Expected approvals - AMP-002 CRL responded; GDUFA Q2 2023 - AMP-015 (Teriparatide) CRL received, planned response Q1 2025 - AMP-007 GDUFA Q2 2025 - AMP-018 (GLP-1) GDUFA Q2 2025 Key Growth Drivers in 2025 ■ AMP-007 ANDA ■ AMP-018 ANDA GLP-1 ■ AMP-004 BLA resubmitted Q4 2024 ■ Intranasal Naloxone Rx to OTC switch ■ AMP-017 ANDA Milestones Recent Filings Planned Filings in 2025