Agios Pharmaceuticals Files 2024 10-K

TL;DR

Agios Pharma 2024 10-K is in. Full year financials and strategy details out now.

AI Summary

Agios Pharmaceuticals, Inc. filed its 2024 10-K on February 13, 2025, reporting on its fiscal year ending December 31, 2024. The company, headquartered in Cambridge, MA, operates in the pharmaceutical preparations sector. Key financial details and operational highlights for the fiscal year are detailed within the report.

Why It Matters

This filing provides investors and stakeholders with a comprehensive overview of Agios Pharmaceuticals' financial performance, strategic direction, and risk factors for the fiscal year 2024.

Risk Assessment

Risk Level: medium — 10-K filings inherently carry medium risk due to the detailed financial and operational information that can impact stock valuation.

Key Numbers

• 20241231 — Fiscal Year End (Reporting period for the 10-K)
• 20250213 — Filing Date (Date the 10-K was submitted to the SEC)

Key Players & Entities

• AGIOS PHARMACEUTICALS, INC. (company) — Filer
• 20241231 (date) — Fiscal Year End
• 20250213 (date) — Filing Date
• 88 SIDNEY STREET, CAMBRIDGE, MA 02139 (location) — Business Address
• 001-36014 (dollar_amount) — SEC File Number

FAQ

Key Financial Figures

• $0.001 — ich Registered Common Stock, Par Value $0.001 per share AGIO Nasdaq Global Select Mar
• $673.7 m — or the year ended December 31, 2024 was $673.7 million, our net loss for the year ended
• $352.1 million — or the year ended December 31, 2023 was $352.1 million and our net loss for the year ended Dec
• $231.8 million — or the year ended December 31, 2022 was $231.8 million. The net income we generated in the yea
• $148.9 million — 2024, we had an accumulated deficit of $148.9 million. We currently rely and expect to conti
• $17.5 million — in-process research and development of $17.5 million in the year ended December 31, 2023. We
• $130.0 million — onally, we are responsible to pay up to $130.0 million in potential development and regulatory
• $1.8 billion — rograms, for a payment of approximately $1.8 billion in cash at the closing, subject to cert
• $200.0 million — o certain adjustments, and a payment of $200.0 million in cash, if, prior to January 1, 2027,
• $25.0 million — ibb's IDHIFA and the right to receive a $25.0 million potential milestone payment under our p
• $127.9 million — rs, or Sagard, and recognized income of $127.9 million within the gain on sale of contingent p
• $905.0 million — ments 2019 ICAV, or Royalty Pharma, for $905.0 million in cash, or the Upfront Payment. The sa
• $1.0 billion — nts made by Servier on account of up to $1.0 billion in U.S. net sales for each calendar yea
• $889.1 million — lt of the sale, we recognized income of $889.1 million ($905.0 million net of fees of $15.9 mi
• $15.9 million — million ($905.0 million net of fees of $15.9 million) within the gain on sale of contingent

Filing Documents

• agio-20241231.htm (10-K) — 1992KB
• agio-ex104x123124.htm (EX-10.4) — 42KB
• agio-ex191x123124.htm (EX-19.1) — 56KB
• agio-ex211x123124.htm (EX-21.1) — 5KB
• agio-ex231x123124.htm (EX-23.1) — 2KB
• exhibit31-1x12x31x24.htm (EX-31.1) — 9KB
• exhibit31-2x12x31x24.htm (EX-31.2) — 9KB
• exhibit32-1x12x31x24.htm (EX-32.1) — 5KB
• exhibit32-2x12x31x24.htm (EX-32.2) — 5KB
• agio-20241231_g1.jpg (GRAPHIC) — 627KB
• agio-20241231_g2.jpg (GRAPHIC) — 364KB
• 0001439222-25-000009.txt ( ) — 11314KB
• agio-20241231.xsd (EX-101.SCH) — 61KB
• agio-20241231_cal.xml (EX-101.CAL) — 93KB
• agio-20241231_def.xml (EX-101.DEF) — 211KB
• agio-20241231_lab.xml (EX-101.LAB) — 750KB
• agio-20241231_pre.xml (EX-101.PRE) — 502KB
• agio-20241231_htm.xml (XML) — 1169KB

Risk Factors

Item 1A. Risk Factors 36

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 64

Cybersecurity

Item 1C. Cybersecurity 64

Properties

Item 2. Properties 65

Legal Proceedings

Item 3. Legal Proceedings 65

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 65 PART II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 66

Reserved

Item 6. Reserved 67

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

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 68

Quantitative and Qualitative Disclosures about Market Risk

Item 7A. Quantitative and Qualitative Disclosures about Market Risk 82

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 82

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 82

Controls and Procedures

Item 9A. Controls and Procedures 82

Other Information

Item 9B. Other Information 83

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 84 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 85

Executive Compensation

Item 11. Executive Compensation 85

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

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 85

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 85

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 85 PART IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 86

Form 10-K Summary

Item 16. Form 10-K Summary 89 i Table of Content s PART I References to Agios Throughout this Annual Report on Form 10-K, "the Company," "Agios," "we," "us," and "our," and similar expressions, except where the context requires otherwise, refer to Agios Pharmaceuticals, Inc. and its consolidated subsidiaries, and "our board of directors" refers to the board of directors of Agios Pharmaceuticals, Inc. Cautionary Note Regarding Forward-looking Information This Annual Report on Form 10-K contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this Annual Report on Form 10-K, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "goal," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "strategy," "target," "vision," "will," "would" or the negatives of these words and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this Annual Report on Form 10-K include, among other things, statements regarding: our commercialization efforts and plans to commercialize PYRUKYND (mitapivat); the initiation, timing, progress and results of current, planned and future preclinical studies and clinical trials, and our research and development programs; the potential of the isoforms of pyruvate kinase, including pyruvate kinase-R, or PKR, as therapeutic targets; the potential benefits of our products and product candidates targeting PKR, including PYRUKYND (mitapivat) and tebapivat, and of our product candidate in our phenylalanine hydroxylase, or PAH, stabilizer program, AG-181, and o

Business

Item 1. Business General We are a biopharmaceutical company committed to transforming patients' lives through leadership in the field of cellular metabolism, with the goal of creating differentiated medicines for rare diseases, with a focus on classical hematology. With a history of focused study on cellular metabolism, we have a deep and mature understanding of this biology, which is involved in the healthy functioning of nearly every system in the body. Building on this expertise, these learnings can be rapidly applied to our clinical trials with the goal of developing medicines that can have a significant impact for patients. We accelerate the impact of our portfolio by cultivating connections with patient communities, healthcare professionals, partners and colleagues to discover, develop and deliver potential therapies for rare diseases. Business Overview Rare diseases The lead product candidate in our portfolio, PYRUKYND (mitapivat), is an activator of both wild-type and mutant pyruvate kinase, or PK, enzymes for the potential treatment of hemolytic anemias. PYRUKYND is approved for use by the U.S. Food and Drug Administration, or FDA, for the treatment of hemolytic anemia in adults with PK deficiency in the United States and by the European Commission for the treatment of PK deficiency in adult patients in the European Union, or EU. Additionally, we received marketing authorization in Great Britain for PYRUKYND for the treatment of PK deficiency in adult patients under the European Commission Decision Reliance Procedure. In December 2024, we announced that we submitted a supplemental new drug application, or sNDA, to the FDA for PYRUKYND for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia, which was accepted with standard review by the FDA and granted a Prescription Drug User Fee Act, or PDUFA, goal date of September 7, 2025. Also in December 2024, we announced that we submitted a marketi

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