Amphastar Pharmaceuticals, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Amphastar Pharmaceuticals, Inc. has filed its 2023 10-K report, detailing financial performance and corporate activities.</b>

AI Summary

Amphastar Pharmaceuticals, Inc. (AMPH) filed a Annual Report (10-K) with the SEC on February 29, 2024. Amphastar Pharmaceuticals, Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company is classified under Pharmaceutical Preparations (SIC 2834). The filing includes data related to various financial statement line items for the years 2020-2023. Specific references to 'TwoPercentConvertibleSeniorNotesDueTwoThousandTwentyNine' and 'Wells Fargo Bank' are present. The report details equity incentive plans and share repurchase plans.

Why It Matters

For investors and stakeholders tracking Amphastar Pharmaceuticals, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Amphastar's financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The detailed financial data and disclosures within the 10-K are essential for regulatory compliance and for stakeholders to understand the company's financial position, including debt, equity, and liabilities.

Risk Assessment

Risk Level: medium — Amphastar Pharmaceuticals, Inc. shows moderate risk based on this filing. The filing is a standard 10-K annual report, which typically contains a broad range of financial and operational information, but lacks specific forward-looking guidance or significant new disclosures that would drastically alter the risk profile based solely on the header information.

Analyst Insight

Review the full 10-K filing to analyze Amphastar's detailed financial statements, management discussion, and risk factors for a comprehensive understanding of its 2023 performance and outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-29 — Filing Date (Date of submission)
• 2023 — Reporting Year (Primary year for financial data)
• 2022 — Prior Year (Comparative financial data year)
• 2021 — Prior Year (Comparative financial data year)
• 2020 — Prior Year (Comparative financial data year)

Key Players & Entities

• Amphastar Pharmaceuticals, Inc. (company) — Filer name
• AMPH (company) — Ticker symbol
• 2023-12-31 (date) — Fiscal year end
• 2024-02-29 (date) — Filing date
• 2834 (industry) — Standard Industrial Classification for Pharmaceutical Preparations
• Wells Fargo Bank (company) — Mentioned in relation to convertible notes
• TwoPercentConvertibleSeniorNotesDueTwoThousandTwentyNine (dollar_amount) — Type of debt instrument

FAQ

Industry Context

Amphastar Pharmaceuticals operates within the pharmaceutical preparations industry, focusing on the development, manufacturing, and marketing of generic and proprietary injectable, inhalation, and topical products.

Regulatory Implications

The company is subject to regulatory oversight by bodies such as the U.S. Food and Drug Administration (FDA) for drug approval, manufacturing standards, and marketing practices.

What Investors Should Do

1. Analyze Amphastar's revenue streams and product portfolio in detail from the full 10-K.
2. Examine the company's debt structure, including convertible notes, and its implications for financial leverage.
3. Review any disclosed risk factors related to regulatory changes, competition, or operational challenges.

Year-Over-Year Comparison

This is the initial header information for the 2023 10-K filing; comparative data from the previous year's filing would be found within the full document.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share AMPH The NASDAQ Stock Mar
• $644.4 m — , and 2021, we recorded net revenues of $644.4 million, $499.0 million, and $437.8 milli
• $499.0 m — ecorded net revenues of $644.4 million, $499.0 million, and $437.8 million, respectively
• $437.8 m — of $644.4 million, $499.0 million, and $437.8 million, respectively. We recorded net in
• $137.5 m — respectively. We recorded net income of $137.5 million, $91.4 million, and $62.1 million
• $91.4 m — recorded net income of $137.5 million, $91.4 million, and $62.1 million for the years
• $62.1 million — e of $137.5 million, $91.4 million, and $62.1 million for the years ended December 31, 2023,
• $340 billion — injectable drug market in 2023 was over $340 billion. Our generic development, including int
• $11 billion — olio is targeting opportunities in over $11 billion of this market. The injectable market r
• $29 billion — n drug market in 2023 was approximately $29 billion. Our generic development portfolio is t
• $6 billion — olio is targeting opportunities in over $6 billion of this market. Inhalation drug therapy

Filing Documents

• amph-20231231x10k.htm (10-K) — 4404KB
• amph-20231231xex99d33.htm (EX-99.33) — 70KB
• amph-20231231xex21d1.htm (EX-21.1) — 16KB
• amph-20231231xex23d1.htm (EX-23.1) — 13KB
• amph-20231231xex31d1.htm (EX-31.1) — 19KB
• amph-20231231xex31d2.htm (EX-31.2) — 19KB
• amph-20231231xex32d1.htm (EX-32.1) — 9KB
• amph-20231231xex32d2.htm (EX-32.2) — 9KB
• amph-20231231xex97d1.htm (EX-97.1) — 44KB
• amph-20231231x10k001.jpg (GRAPHIC) — 66KB
• 0001297184-24-000009.txt (&nbsp;) — 17558KB
• amph-20231231.xsd (EX-101.SCH) — 98KB
• amph-20231231_cal.xml (EX-101.CAL) — 111KB
• amph-20231231_def.xml (EX-101.DEF) — 428KB
• amph-20231231_lab.xml (EX-101.LAB) — 763KB
• amph-20231231_pre.xml (EX-101.PRE) — 721KB
• amph-20231231x10k_htm.xml (XML) — 3419KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 30 Item 1B. Unresolved Staff Comments 82 Item 1C. Cybersecurity 82 Item 2.

Properties

Properties 83 Item 3.

Legal Proceedings

Legal Proceedings 84 Item 4. Mine Safety Disclosures 84 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 85 Item 6. [ Reserved ] 86 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 87 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 100 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 102 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 149 Item 9A.

Controls and Procedures

Controls and Procedures 149 Item 9B. Other Information 151 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 151 Part III Item 10. Directors, Executive Officers and Corporate Governance 152 Item 11.

Executive Compensation

Executive Compensation 152 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 152 Item 13. Certain Relationships and Related Transactions, and Director Independence 152 Item 14. Principal Accountant Fees and Services 152 Part IV Item 15. Exhibits and Financial Statement Schedules 153 Item 16. Form 10-K Summary 156

Signatures

Signatures 157 Table of Contents SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Annual Report, contains "forward-looking statements" that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements relate to future events or future financial performance or condition and involve known and unknown risks, uncertainties and other factors that could cause actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, statements about: our expectations regarding the sales and marketing of our products; our expectations regarding our newly acquired product, BAQSIMI , including with respect to our ability to increase our revenues and derive certain benefits as a result of our acquisition of BAQSIMI ; our ability to successfully acquire and integrate assets, including our ability to integrate BAQSIMI ; our expectations regarding our manufacturing and production and the integrity of our supply chain for our products, including the risks associated with our single source suppliers; our business and operations in general, including: adverse impacts of the Russia-Ukraine and Middle East conflicts and challenging macroeconomic conditions on our business, financial condition, operations, cash flows and liquidity; our ability to attract, hire, and retain highly skilled personnel; interruptions to our manufacturing and production as a result of natural catastrophic events or other

Business

Item 1. Business. Overview We are a bio-pharmaceutical company focusing primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin active pharmaceutical ingredient, or insulin API products. We currently manufacture and sell over 25 products, the overwhelming majority of which are prescription pharmaceuticals. Since December 2018, we have sold our patented Primatene MIST using a new hydrofluoroalkanes, or HFA, formulation as our sole over-the-counter product. Our largest products by net revenues currently include BAQSIMI glucagon nasal powder, or BAQSIMI , Primatene MIST , glucagon, epinephrine, phytonadione, and lidocaine. In April 2022, the FDA approved our ganirelix acetate injection 250mg/0.5mL prefilled syringe, which we launched in June 2022. In July 2022, the FDA approved our vasopressin injection, USP 20 Units/mL, 1 mL single-dose vial, which we launched in August 2022. In May 2022, the FDA approved our regadenoson injection, 0.08mg/mL, 5mL, single-dose prefilled syringe, which we launched in April 2023. In March 2023, the FDA approved our naloxone hydrochloride nasal spray 4mg, REXTOVY TM , which we plan to launch in the first quarter of 2024. In June 2023, we completed our acquisition of BAQSIMI , the first and only nasally administered glucagon for the treatment of severe hypoglycemia in people with diabetes, and is currently available in 27 international markets. For the years ended December 31, 2023, 2022, and 2021, we recorded net revenues of $644.4 million, $499.0 million, and $437.8 million, respectively. We recorded net income of $137.5 million, $91.4 million, and $62.1 million for the years ended December 31, 2023, 2022, and 2021, respectively. We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biosimilar insulin product candidates and proprietary product candidates, which are in