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

TL;DR

<b>ANI Pharmaceuticals Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

ANI PHARMACEUTICALS INC (ANIP) filed a Annual Report (10-K) with the SEC on February 29, 2024. ANI Pharmaceuticals Inc. filed its 2023 Form 10-K on February 29, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 210 Main Street West, Baudette, MN 56623. ANI Pharmaceuticals Inc. was formerly known as BIOSANTE PHARMACEUTICALS INC and BEN ABRAHAM TECHNOLOGIES INC. The filing includes financial data for the fiscal years 2020, 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking ANI PHARMACEUTICALS INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of ANI Pharmaceuticals' financial health, operational activities, and strategic direction for the past fiscal year, crucial for investors to assess performance and future prospects. The detailed financial statements and risk factors within the report are essential for stakeholders to understand the company's financial position, potential risks, and compliance with regulatory requirements.

Risk Assessment

Risk Level: medium — ANI PHARMACEUTICALS INC shows moderate risk based on this filing. The company's financial performance and future outlook are subject to various risks inherent in the pharmaceutical industry, including regulatory changes, market competition, and product development challenges, as detailed in the full 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess ANI Pharmaceuticals' financial health and strategic positioning.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-29 — Filing Date (Date of 10-K submission)
• 2023 — Fiscal Year (Year covered by the report)
• 2022 — Prior Fiscal Year (Comparative financial data)

Key Players & Entities

• ANI PHARMACEUTICALS INC (company) — Filer name
• BIOSANTE PHARMACEUTICALS INC (company) — Former company name
• BEN ABRAHAM TECHNOLOGIES INC (company) — Former company name
• 210 MAIN STREET WEST (location) — Business address
• BAUDETTE (location) — City in business address
• MN (location) — State in business address
• 56623 (location) — ZIP code in business address
• 2023-12-31 (date) — Fiscal year end

FAQ

Industry Context

ANI Pharmaceuticals Inc. operates within the pharmaceutical preparations industry, focusing on the development, manufacturing, and marketing of prescription drugs.

Regulatory Implications

The company is subject to the regulations of the U.S. Securities and Exchange Commission (SEC) for its public filings, including the annual 10-K report.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing ANI Pharmaceuticals.
3. Compare the 2023 financial results with previous years to identify trends and assess performance.

Key Dates

• 2024-02-29: 10-K Filing — Submission of the annual report for the fiscal year ended December 31, 2023.

Year-Over-Year Comparison

This filing represents the annual report for the fiscal year ending December 31, 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.0001 — ch registered Common Stock , par value $0.0001 per share ANIP The Nasdaq Global Marke
• $53.83 — ed upon the last reported sale price of $53.83 per share on June 30, 2023, on The Nasd
• $14.2 million — lion Canadian Dollars, or approximately $14.2 million US Dollars, based on the current exchan
• $80.6 million — in net proceeds after issuance costs of $80.6 million. We have a commercial portfo lio of 11

Filing Documents

• anip-20231231.htm (10-K) — 2325KB
• anip-2023x1231xexx1024.htm (EX-10.24) — 12KB
• anip-2023x1231xexx1031.htm (EX-10.31) — 172KB
• anip-20231231xexx1032.htm (EX-10.32) — 21KB
• anip-20231231xexx1033.htm (EX-10.33) — 9KB
• anip-20231231xexx1034.htm (EX-10.34) — 77KB
• anip-20231231xexx21.htm (EX-21) — 6KB
• anip-2023x1231xexx231.htm (EX-23.1) — 3KB
• anip-20231231xexx311.htm (EX-31.1) — 10KB
• anip-20231231xexx312.htm (EX-31.2) — 10KB
• anip-20231231xexx321.htm (EX-32.1) — 7KB
• anip-20231231xexx971.htm (EX-97.1) — 36KB
• anip-20231231_g1.jpg (GRAPHIC) — 265KB
• 0001023024-24-000026.txt (&nbsp;) — 13320KB
• anip-20231231.xsd (EX-101.SCH) — 72KB
• anip-20231231_cal.xml (EX-101.CAL) — 112KB
• anip-20231231_def.xml (EX-101.DEF) — 547KB
• anip-20231231_lab.xml (EX-101.LAB) — 1106KB
• anip-20231231_pre.xml (EX-101.PRE) — 820KB
• anip-20231231_htm.xml (XML) — 1646KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 13 Item 1B. Unresolved Staff Comments 40 I tem 1C. Cybersecurity 40 Item 2.

Properties

Properties 41 Item 3.

Legal Proceedings

Legal Proceedings 41 Item 4. Mine Safety Disclosures 41 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 42 Item 6. Reserved 44 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 45 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 60 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 62 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 116 Item 9A.

Controls and Procedures

Controls and Procedures 116 Item 9B. Other Information 117 Item 9C. Disclosures Regarding Foreign Jurisdictions that Prevent Inspections 117 PART III Item 10. Directors, Executive Officers and Corporate Governance 118 Item 11.

Executive Compensation

Executive Compensation 118 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 118 Item 13. Certain Relationships and Related Transactions, and Director Independence 118 Item 14. Principal Accountant Fees and Services 118 PART IV Item 15. Exhibits and Financial Statement Schedules 119 Item 16. Form 10-K Summary 124

Signatures

Signatures 125 Table of Contents In this annual report, references to "ANI Pharmaceuticals," "ANI," the "Company," "we," "us," and "our" refer, unless the context requires otherwise, to ANI Pharmaceuticals, Inc., a Delaware corporation, and its consolidated subsidiaries. CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K and certain information incorporated herein by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Such statements include, but are not limited to, statements about future operations, strategies and growth potential, the revenue potential (licensing, royalty and sales) of products we sell, development timelines, expected timeframe for submission of new drug applications, abbreviated new drug applications, or supplemental new drug applications to the U.S. Food and Drug Administration (the "FDA"), pipeline or potential markets for our products, selling and marketing strategies and associated costs to support the sales of Purified Cortrophin Gel (Repository Corticotropin Injection USP) ("Cortrophin Gel"), impact of accounting principles, litigation expenses, liquidity and capital resources, the impact of the novel coronavirus ("COVID-19") global pandemic on our business, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "plans," "potential," "future," "believes," "intends," "continue," other words of similar meaning, derivations of such words, and the use of future dates. Such forward-looking statements are based on the reasonable beliefs of our management as well as assumptions made by and information currently available to our management. Readers should not put undue reliance on these forward-looking statements. Forward-looking stateme

Business

Item 1. Business ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, "ANI," the "Company," "we," "us," or "our") is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals, including for diseases with high unmet medical need. The team is focused on delivering growth by scaling up the Rare Disease business through the successful launch of its lead asset, Cortrophin Gel, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. The Company's three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment. The Company has ceased operations at our subsidiary in Oakville, Ontario, Canada as of March 31, 2023. This action was part of ongoing initiatives to capture operational synergies following our acquisition of Novitium Pharma LLC ("Novitium") in November 2021. The Company has fully completed the transition of the products manufactured or packaged in Oakville to one of the three U.S.-based manufacturing sites. On November 6, 2023, ANI Pharmaceuticals Canada Inc., a wholly owned subsidiary of the Company, entered into an agreement for the purchase and sale of the Oakville, Ontario manufacturing facility. However, during December 3023, the agreement was mutually terminated. In February 2024, the Company entered into an agreement for the purchase and sale of the Oakville site, for a purchase price of 19.2 million Canadian Dollars, or approximately $14.2 million US Dollars, based on the current exchange rate. The sale is expected to close in March

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View this 10-K filing on SEC EDGAR