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

TL;DR

<b>Agios Pharmaceuticals filed its 2023 10-K, detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

AGIOS PHARMACEUTICALS, INC. (AGIO) filed a Annual Report (10-K) with the SEC on February 15, 2024. Agios Pharmaceuticals, Inc. reported its 2023 fiscal year results on February 15, 2024. The company's fiscal year ends on December 31st. The filing is a 10-K annual report. The company is incorporated in Delaware. Agios Pharmaceuticals is in the Pharmaceutical Preparations industry (SIC 2834).

Why It Matters

For investors and stakeholders tracking AGIOS PHARMACEUTICALS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Agios's financial health, strategic initiatives, and risk factors for investors and stakeholders. Understanding the details within this report is crucial for assessing the company's performance, future outlook, and potential investment value.

Risk Assessment

Risk Level: medium — AGIOS PHARMACEUTICALS, INC. shows moderate risk based on this filing. The company operates in the highly competitive pharmaceutical industry, facing risks related to drug development, regulatory approvals, and market adoption, as indicated by its industry classification and the nature of a 10-K filing.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to assess Agios's long-term growth prospects and competitive positioning.

Revenue Breakdown

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period end date)
• 2024-02-15 — Filing Date (Date the 10-K was filed)
• 001-36014 — SEC File Number (SEC filing identifier)
• 24642625 — Film Number (SEC film identifier)

Key Players & Entities

• AGIOS PHARMACEUTICALS, INC. (company) — Filer name
• AGIO (company) — Ticker symbol
• 2023-12-31 (date) — Fiscal year end
• 2024-02-15 (date) — Filing date
• DE (jurisdiction) — State of incorporation
• 2834 (industry) — Standard Industrial Classification
• 617-649-8600 (phone) — Business phone number
• Alnylam Pharmaceuticals, Inc. (company) — Mentioned in relation to royalty or product segments.

FAQ

Risk Factors

• Regulatory Risks [medium — regulatory]: The company faces risks associated with the stringent regulatory environment for pharmaceutical products, including approval processes and post-market surveillance.
• Market Competition [medium — market]: The pharmaceutical market is highly competitive, with potential risks from existing and new market entrants and the success of competitor products.
• Drug Development and Commercialization [high — operational]: Risks related to the success of drug development programs, clinical trials, manufacturing, and commercialization of products.
• Financial Performance [medium — financial]: The company's financial performance is subject to risks including revenue generation, cost management, and access to capital.
• Intellectual Property [medium — legal]: Risks associated with protecting intellectual property rights and potential patent litigation.

Key Financial Figures

• $0.001 — ich Registered Common Stock, Par Value $0.001 per share AGIO Nasdaq Global Select Mar
• $352.1 m — or the year ended December 31, 2023 was $352.1 million, our net loss for the year ended
• $231.8 million — or the year ended December 31, 2022 was $231.8 million and our net income for the year ended D
• $1.6 billion — or the year ended December 31, 2021 was $1.6 billion. The net income we generated in the yea
• $822.6 million — 2023, we had an accumulated deficit of $822.6 million. 2 Table of Content s We currently
• $17.5 million — in-process research and development of $17.5 million. We will also pay Alnylam for certain e
• $130.0 million — onally, we are responsible to pay up to $130.0 million in potential development and regulatory
• $1.8 billion — Servier, 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

Filing Documents

• agio-20231231.htm (10-K) — 1988KB
• exhibit-1021x123123.htm (EX-10.21) — 188KB
• agio-ex211x123123.htm (EX-21.1) — 5KB
• agio-ex231x123123.htm (EX-23.1) — 2KB
• exhibit31-1x12x31x23.htm (EX-31.1) — 9KB
• exhibit31-2x12x31x23.htm (EX-31.2) — 9KB
• exhibit32-1x12x31x23.htm (EX-32.1) — 5KB
• exhibit32-2x12x31x23.htm (EX-32.2) — 5KB
• exhibit-971x123123.htm (EX-97.1) — 21KB
• agio-20231231_g1.jpg (GRAPHIC) — 204KB
• agio-20231231_g2.jpg (GRAPHIC) — 374KB
• image_0a.jpg (GRAPHIC) — 73KB
• image_1a.jpg (GRAPHIC) — 219KB
• 0001439222-24-000035.txt (&nbsp;) — 10880KB
• agio-20231231.xsd (EX-101.SCH) — 64KB
• agio-20231231_cal.xml (EX-101.CAL) — 104KB
• agio-20231231_def.xml (EX-101.DEF) — 236KB
• agio-20231231_lab.xml (EX-101.LAB) — 838KB
• agio-20231231_pre.xml (EX-101.PRE) — 524KB
• agio-20231231_htm.xml (XML) — 1141KB

Risk Factors

Item 1A. Risk Factors 34

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 65

Cybersecurity

Item 1C. Cybersecurity 65

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 81

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 83 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 84

Executive Compensation

Item 11. Executive Compensation 84

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 84

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 84

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 84 PART IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 85

Form 10-K Summary

Item 16. Form 10-K Summary 88 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 AG-946, and of our product candidate in our phenylalanine hydroxylase, or PAH, stabilizer program, AG-181; our pla

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. In February 2022, the U.S. Food and Drug Administration, or FDA, approved PYRUKYND for the treatment of hemolytic anemia in adults with PK deficiency in the United States. In November 2022, we received marketing authorization from the European Commission for PYRUKYND for the treatment of PK deficiency in adult patients in the European Union, or EU. In December 2022, 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 addition, we are currently evaluating PYRUKYND in clinical trials for the treatment of thalassemia, sickle cell disease, or SCD, and in pediatric patients with PK deficiency. We are also developing (i) AG-946, a novel PK activator, for the potential treatment of lower-risk myelodysplastic syndrome, or LR MDS, and hemolytic anemias, and (ii) AG-181, our phenylalan

View Full Filing

View this 10-K filing on SEC EDGAR