AGENUS INC. 2023 Annual Report (10-K)

TL;DR

<b>Agenus Inc. filed its 2023 10-K, detailing its financial performance and business operations.</b>

AI Summary

AGENUS INC (AGEN) filed a Annual Report (10-K) with the SEC on March 14, 2024. Agenus Inc. filed its 2023 10-K report on March 14, 2024. The company's fiscal year ends on December 31st. Agenus Inc. is incorporated in Delaware. The company's principal business is in Biological Products. The filing includes details on various agreements and financial instruments.

Why It Matters

For investors and stakeholders tracking AGENUS INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Agenus Inc.'s financial health, operational status, and strategic initiatives for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's performance, identify potential risks, and make informed investment decisions.

Risk Assessment

Risk Level: medium — AGENUS INC shows moderate risk based on this filing. The company's financial performance and future prospects are subject to the inherent risks and uncertainties of the biotechnology industry, including regulatory approvals, clinical trial outcomes, and market competition.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to understand Agenus Inc.'s current financial position and future growth potential.

Key Numbers

• 20231231 — Fiscal Year End (FISCAL YEAR END)
• 19991115 — Date of Name Change (DATE OF NAME CHANGE)
• 20240314 — Filed As Of Date (FILING VALUES)
• 2023-01-01 — Reporting Period Start (FILING VALUES)
• 2023-12-31 — Reporting Period End (FILING VALUES)

Key Players & Entities

• AGENUS INC (company) — FILER
• 0000950170-24-031620 (document_id) — ACCESSION NUMBER
• 20231231 (date) — CONFORMED PERIOD OF REPORT
• 20240314 (date) — FILED AS OF DATE
• DE (location) — STATE OF INCORPORATION
• 2836 (industry_code) — STANDARD INDUSTRIAL CLASSIFICATION
• 781-674-4410 (phone) — BUSINESS PHONE
• ANTIGENICS INC /DE/ (company) — FORMER COMPANY

FAQ

Industry Context

Agenus Inc. operates within the Biological Products sector, focusing on the development and commercialization of innovative therapies.

Regulatory Implications

The company's operations are subject to regulatory oversight by agencies such as the FDA, which govern the development, testing, and marketing of pharmaceutical products.

What Investors Should Do

1. Analyze the company's revenue streams and growth drivers.
2. Evaluate the company's cash position and debt levels.
3. Assess the identified risks and their potential impact on the business.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, providing a baseline for future comparisons.

Key Financial Figures

• $200.0 million — non-refundable upfront cash payment of $200.0 million and, as of December 31, 2023, are eligi
• $1.32 billion — 31, 2023, are eligible to receive up to $1.32 billion in aggregate development, regulatory an
• $20.0 million — trial, triggering the achievement of a $20.0 million milestone. Under the BMS License Agreem
• $25.0 million — (also known as AGEN1777), triggering a $25.0 million milestone payment from BMS. In June 2
• $15.0 million — he Betta License Agreement, we received $15.0 million upfront and are eligible to receive up
• $100.0 million — front and are eligible to receive up to $100.0 million in milestone payments plus royalties on
• $120.0 million — an upfront cash payment from Gilead of $120.0 million following the closing in January 2019.
• $5.0 million — payments. In March 2022, we received a $5.0 million clinical milestone under the AGEN2373 o
• $50.0 million — eement, we remain eligible to receive a $50.0 million option exercise fee and, if exercised,
• $520.0 million — and, if exercised, up to an additional $520.0 million in aggregate milestone payments, as wel
• $155.0 million — , we were eligible to receive (i) up to $155.0 million in future contingent development, regul
• $10.0 million — inical trial with MK-4830, triggering a $10.0 million milestone payment to us. Under the term
• $15.0 — lty Purchase Agreement, XOMA US paid us $15.0

Filing Documents

• agen-20231231.htm (10-K) — 4993KB
• agen-ex10_9a.htm (EX-10.9A) — 14KB
• agen-ex21_1.htm (EX-21.1) — 4KB
• agen-ex23_1.htm (EX-23.1) — 4KB
• agen-ex31_1.htm (EX-31.1) — 14KB
• agen-ex31_2.htm (EX-31.2) — 15KB
• agen-ex32_1.htm (EX-32.1) — 10KB
• agen-ex97_1.htm (EX-97.1) — 43KB
• img189631100_0.jpg (GRAPHIC) — 287KB
• img189631100_1.jpg (GRAPHIC) — 157KB
• img189631100_2.jpg (GRAPHIC) — 130KB
• 0000950170-24-031620.txt (&nbsp;) — 18564KB
• agen-20231231.xsd (EX-101.SCH) — 2153KB
• agen-20231231_htm.xml (XML) — 3095KB

BUSINESS

BUSINESS 3 Our Business 3 Intellectual Property Portfolio 8 Regulatory Compliance 9 Competition 10 Human Capital Resources and Employees 12 Corporate History 12 Availability of Periodic SEC Reports 12 ITEM 1A.

RISK FACTORS

RISK FACTORS 12 ITEM 1B. UNRESOLVED STAFF COMMENTS 64 ITEM 1C. CYBERSECURITY 65 ITEM 2.

PROPERTIES

PROPERTIES 65 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 65 ITEM 4. MINE SAFETY DISCLOSURES 65 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 67 ITEM 6. RESERVED 68 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 69 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 77 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 78 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 118 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 119 PART III ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 120 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 128 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 153 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 155 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 157 PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 158 ITEM 16 FORM 10-K SUMMARY 163 Note Regarding Forward-Looking Statements This Annual Report on Form 10-K and other written and oral statements the Company makes from time to time contain forward-looking statements. You can identify these forward-looking statements by the fact they use words such as "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will," "potential," "opportunity," "future" and other words and terms of similar meaning. Forward-looking statements include discussion of future operating or financial performance. You also can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve risks and uncertainties that could delay, divert or change any of them, and could cause actual outcomes to differ materially. These statements relate to, among other things, our business strategy, our research and development, our product development efforts, our ability to commercialize our product candidates, the activities of our licensees, our prospects for initiating partnerships or collaborations, the timing of the introduction of products, the effect of new accounting pronouncements, our future operating results and our potential profitability, availability of additional capital as well as our plans, objectives, expectations, and intentions. Although we believe we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved, and readers are cautioned not to place undue reliance on such statements,

B usiness

Item 1. B usiness Our Business We are a clinical-stage biotechnology company specializing in developing therapies to activate the body's immune system against cancer and infections. Our pipeline includes immune-modulatory antibodies, adoptive cell therapies (via MiNK Therapeutics, Inc. ("MiNK")), and vaccine adjuvants (via SaponiQx, Inc. ("SaponiQx")). Our primary focus is immuno-oncology ("I-O"), and our diverse pipeline is supported by our in-house capabilities, including current good manufacturing practice ("cGMP") manufacturing and a clinical operations platform. To succeed in I-O, innovation and speed are paramount. We are a vertically integrated biotechnology company equipped with a suite of technology platforms to advance from novel target identification through manufacturing for clinical trials of antibodies and cell therapies. By understanding each patient's cancer, we aim to substantially expand the population benefiting from current I-O therapies. In addition to a diverse pipeline, we have assembled fully integrated end-to-end capabilities including novel target discovery, antibody generation, cell line development and cGMP manufacturing. Leveraging our science and capabilities, we have established strategic partnerships to advance innovation. We believe the next generation of cancer treatment will build on clinically validated antibodies targeting CTLA-4 and PD-1 combined with novel immunomodulatory agents designed to address underlying tumor escape mechanisms. Our most advanced antibody candidates are botensilimab (a multifunctional immune cell activator and human Fc-enhanced cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody, also known as AGEN1811) and balstilimab (a programmed death receptor-1 (PD-1) blocking antibody). Botensilimab aims to enhance responses to first-generation CTLA-4 antibodies, expand patient populations benefiting from CTLA-4 therapy, and is designed to minimize treatment-related side effects typically associated wi

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View this 10-K filing on SEC EDGAR