Rigel Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>Rigel Pharmaceuticals Inc. has submitted its 2023 10-K annual report, detailing its financial performance and corporate information.</b>

AI Summary

RIGEL PHARMACEUTICALS INC (RIGL) filed a Annual Report (10-K) with the SEC on March 5, 2024. Rigel Pharmaceuticals Inc. filed its annual report for the fiscal year ending December 31, 2023. The company's principal executive offices are located at 611 Gateway Boulevard, Suite 900, South San Francisco, CA 94080. The filing is a 10-K, indicating a comprehensive overview of the company's financial performance and condition. Rigel Pharmaceuticals is classified under SIC code 2834 for Pharmaceutical Preparations. The company's fiscal year ends on December 31st annually.

Why It Matters

For investors and stakeholders tracking RIGEL PHARMACEUTICALS INC, this filing contains several important signals. This 10-K filing provides investors and stakeholders with a detailed look into Rigel's financial health, operational performance, and strategic outlook for the past fiscal year. Understanding the specifics of this report is crucial for assessing the company's current market position, potential risks, and future growth prospects in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — RIGEL 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 evidenced by its classification in the Pharmaceutical Preparations SIC code.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K to assess Rigel Pharmaceuticals' financial stability and future growth potential.

Key Numbers

• 10-K — Form Type (SEC filing type)
• 2834 — SIC Code (Standard Industrial Classification)
• 1231 — Fiscal Year End (Annual fiscal year end date)
• 000-29889 — SEC File Number (SEC filing number)

Key Players & Entities

• RIGEL PHARMACEUTICALS INC (company) — Filer name
• RIGL (company) — Ticker symbol
• 20231231 (date) — Fiscal year end
• 20240305 (date) — Filing date
• 611 GATEWAY BOULEVARD, SUITE 900 (address) — Business address
• SOUTH SAN FRANCISCO (location) — Business address city
• CA (location) — Business address state
• 94080 (postal_code) — Business address zip

FAQ

Industry Context

Rigel Pharmaceuticals operates within the pharmaceutical industry, focusing on the development and commercialization of novel therapies.

Regulatory Implications

As a pharmaceutical company, Rigel is subject to extensive regulation by bodies such as the FDA, impacting drug development, approval, and marketing.

What Investors Should Do

1. Analyze Rigel's revenue streams and cost structure from the 10-K.
2. Evaluate the company's cash position and debt levels.
3. Review the identified risk factors for potential investment implications.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-05: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This is the initial filing data extracted for the 2023 10-K. Comparative data from previous filings would be needed for a full 'vs last filing' analysis.

Key Financial Figures

• $93.7 million — VALISSE in ITP In 2023, we recognized $93.7 million of TAVALISSE net product sales, a 24% i
• $75.8 million — oduct sales, a 24% increase compared to $75.8 million in 2022. The increase in our net produc
• $10.6 million — AML with mIDH1 In 2023, we recognized $10.6 million of REZLIDHIA net product sales, compare
• $0.9 million — EZLIDHIA net product sales, compared to $0.9 million in 2022. The increase was primarily due
• $2.0 m — es agreement, we paid an upfront fee of $2.0 million, with the potential to pay up to
• $67.5 million — illion, with the potential to pay up to $67.5 million additional payments upon achievement of
• $165.5 million — ent and regulatory milestones and up to $165.5 million additional payments upon achievement of
• $17.5 million — e met which entitled Forma to receive a $17.5 million milestone payments. No new milestone wa
• $15.0 m — ed to pay Blueprint a purchase price of $15.0 million, $10.0 million of which is payabl
• $10.0 million — rint a purchase price of $15.0 million, $10.0 million of which is payable upon our first comm
• $5.0 million — GAVRETO (pralsetinib) and an additional $5.0 million of which is payable on the first annive
• $97.5 million — print is also eligible to receive up to $97.5 million in future commercial milestone payments

Filing Documents

• rigl-20231231x10k.htm (10-K) — 2970KB
• rigl-20231231xex10d9.htm (EX-10.9) — 140KB
• rigl-20231231xex23d1.htm (EX-23.1) — 14KB
• rigl-20231231xex31d1.htm (EX-31.1) — 15KB
• rigl-20231231xex31d2.htm (EX-31.2) — 15KB
• rigl-20231231xex32d1.htm (EX-32.1) — 10KB
• rigl-20231231xex97.htm (EX-97) — 44KB
• rigl-20231231x10k003.jpg (GRAPHIC) — 75KB
• rigl-20231231x10k004.jpg (GRAPHIC) — 28KB
• 0001558370-24-002475.txt (&nbsp;) — 12205KB
• rigl-20231231.xsd (EX-101.SCH) — 76KB
• rigl-20231231_cal.xml (EX-101.CAL) — 74KB
• rigl-20231231_def.xml (EX-101.DEF) — 278KB
• rigl-20231231_lab.xml (EX-101.LAB) — 663KB
• rigl-20231231_pre.xml (EX-101.PRE) — 486KB
• rigl-20231231x10k_htm.xml (XML) — 2172KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 41 Item 1B. Unresolved Staff Comments 89 Item 1C. Cybersecurity 89 Item 2.

Properties

Properties 90 Item 3.

Legal Proceedings

Legal Proceedings 91 Item 4. Mine Safety Disclosures 91 PART II 91 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 91 Item 6. [ Reserved ] 92 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 93 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 104 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 105 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 141 Item 9B. Other Information 144 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 144 PART III 144 Item 10. Directors, Executive Officers and Corporate Governance 144 Item 11.

Executive Compensation

Executive Compensation 144 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 144 Item 13. Certain Relationships and Related Transactions, and Director Independence 145 Item 14. Principal Accountant Fees and Services 145 PART IV 145 Item 15. Exhibits and Financial Statement Schedules 145 Item 16. Form 10-K Summary 148

Signatures

Signatures 149 Table of Contents

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains statements indicating expectations about future performance and other forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), and the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. We usually use words such as "may," "will," "would," "should," "could," "expect," "plan," "anticipate," "might," "believe," "estimate," "predict," "intend," or the negative of these terms or similar expressions to identify these forward-looking statements. These statements appear throughout this Annual Report on Form 10-K and are statements regarding our current expectations, beliefs or intent, primarily with respect to our operations and related industry developments. Examples of these statements include, but are not limited to: our business and scientific strategies; risks and uncertainties associated with the commercialization and marketing of our products in the United States (US) and outside the US; risks that the US Food and Drug Administration (FDA), European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) or other regulatory authorities may make adverse decisions regarding our products; the progress of our and our collaborators' product development programs, including clinical testing, and the timing of results thereof; our corporate collaborations and revenues that may be received from our collaborations and the timing of those potential payments; our expectations with respect to regulatory submissions and approvals; our drug discovery technologies; our research and development expense; protection of our intellectual property and our intention to vigorously enforce our intellectual property rights; sufficiency of our cash and capital resources and the need for additional capital; our

Busines s

Item 1. Busines s Overview We are a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms. Our first product approved by the FDA is TAVALISSE (fostamatinib disodium hexahydrate) tablets, the only approved oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The product is also commercially available in Europe and the United Kingdom (UK) (as TAVLESSE), and in Canada, Israel and Japan (as TAVALISSE) for the treatment of chronic ITP in adult patients. Our second FDA-approved product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. We began our commercialization of REZLIDHIA in December 2022. W e in-licensed olutasidenib from Forma Therapeutics, Inc., now Novo Nordisk (Forma), with exclusive, worldwide rights for its development, manufacturing and commercialization. We continue to advance the development of our interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor program, in an open-label, Phase 1b trial to determine the tolerability and preliminary efficacy of the drug in patients with lower-risk myelodysplastic syndrome (MDS) who are refractory or resistant to prior therapies. In February 2024, we entered into an Asset Purchase Agreement with Blueprint to purchase certain assets comprising the right to research, develop, manufacture and commercialize GAVRETO (pralsetinib) in the US. GAVRETO (pralsetinib) is a once daily, small molecule, oral, kinase inhibitor of wild-type rearranged during transfection (RET) and oncogenic RET fusi

View Full Filing

View this 10-K filing on SEC EDGAR