Arcus Biosciences, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Arcus Biosciences, Inc. has filed its annual 10-K report for the fiscal year 2023, detailing its financial performance and business operations.</b>

AI Summary

Arcus Biosciences, Inc. (RCUS) filed a Annual Report (10-K) with the SEC on February 21, 2024. Arcus Biosciences, Inc. filed its 2023 Form 10-K on February 21, 2024, reporting on the fiscal year ending December 31, 2023. The filing covers financial data and business operations for the period. Key financial statement information and disclosures are included. The company is incorporated in Delaware and headquartered in Hayward, California. The SIC code for Arcus Biosciences is 2834 (Pharmaceutical Preparations).

Why It Matters

For investors and stakeholders tracking Arcus Biosciences, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Arcus Biosciences' 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 understanding the company's current standing and potential challenges in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — Arcus Biosciences, Inc. shows moderate risk based on this filing. The company operates in the highly competitive and regulated pharmaceutical industry, facing risks related to drug development, clinical trials, regulatory approvals, and market adoption, as detailed in its 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Arcus Biosciences' financial health and strategic positioning in the competitive biopharmaceutical market.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-02-21 — Filing Date (Filed as of date)
• 001-38419 — SEC File Number (SEC file number)

Key Players & Entities

• Arcus Biosciences, Inc. (company) — Filer name
• 2023 (date) — Fiscal year end
• 2024-02-21 (date) — Filing date
• Hayward, CA (location) — Business address city and state
• 2834 (industry_code) — Standard Industrial Classification

FAQ

Industry Context

Arcus Biosciences operates within the biopharmaceutical industry, focusing on the development of novel cancer therapies. This sector is characterized by extensive research and development, lengthy clinical trial processes, and significant regulatory oversight.

Regulatory Implications

The pharmaceutical industry is subject to stringent regulations from bodies like the FDA, governing drug development, testing, manufacturing, and marketing. Compliance with these regulations is critical for market access and commercialization.

What Investors Should Do

1. Analyze the detailed financial statements for revenue trends, profitability, and cash flow.
2. Review the risk factors section for potential challenges and mitigation strategies.
3. Assess the company's strategic priorities and pipeline developments outlined in the business overview.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-21: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This filing is the 2023 annual report (10-K), providing a comprehensive update compared to previous filings.

Key Financial Figures

• $0.0001 — ich Registered Common Stock, Par Value $0.0001 Per Share RCUS The New York Stock Excha
• $10 billion — Phase 3 trials of domvanalimab is over $10 billion annually, based on the size of the drug

Filing Documents

• rcus-20231231.htm (10-K) — 1859KB
• a104severanceplan.htm (EX-10.4) — 95KB
• a1035olca.htm (EX-10.35) — 128KB
• ex231.htm (EX-23.1) — 5KB
• ex311.htm (EX-31.1) — 10KB
• ex312.htm (EX-31.2) — 10KB
• ex321.htm (EX-32.1) — 5KB
• ex322.htm (EX-32.2) — 5KB
• a971policy.htm (EX-97.1) — 24KB
• rcus-20231231_g1.jpg (GRAPHIC) — 18KB
• rcus-20231231_g2.jpg (GRAPHIC) — 179KB
• rcus-20231231_g3.jpg (GRAPHIC) — 88KB
• rcus-20231231_g4.jpg (GRAPHIC) — 92KB
• rcus-20231231_g5.jpg (GRAPHIC) — 44KB
• rcus-20231231_g6.jpg (GRAPHIC) — 22KB
• rcus-20231231_g7.jpg (GRAPHIC) — 36KB
• rcus-20231231_g8.jpg (GRAPHIC) — 61KB
• 0001724521-24-000052.txt (&nbsp;) — 10582KB
• rcus-20231231.xsd (EX-101.SCH) — 78KB
• rcus-20231231_cal.xml (EX-101.CAL) — 82KB
• rcus-20231231_def.xml (EX-101.DEF) — 328KB
• rcus-20231231_lab.xml (EX-101.LAB) — 810KB
• rcus-20231231_pre.xml (EX-101.PRE) — 534KB
• rcus-20231231_htm.xml (XML) — 1264KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 26 Item 1B. Unresolved Staff Comments 52

Cybersecurity

Item 1C. Cybersecurity 52 Item 2.

Properties

Properties 53 Item 3.

Legal Proceedings

Legal Proceedings 53 Item 4. Mine Safety Disclosures 54 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 55 Item 6. Reserved 55 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 56 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 65 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 66 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 97 Item 9A.

Controls and Procedures

Controls and Procedures 97 Item 9B. Other Information 100 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 100 PART III Item 10. Directors, Executive Officers and Corporate Governance 101 Item 11.

Executive Compensation

Executive Compensation 101 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 101 Item 13. Certain Relationships and Related Transactions, and Director Independence 101 Item 14 . Principal Accounting Fees and Services 101 PART IV Item 15 . Exhibits and Financial Statement Schedules 102 Item 16 Form 10-K Summary 102 Table of Contents INFORMATION REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K ("Annual Report") includes "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"). These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements about: our expectations regarding our relationship with Gilead; our expectations regarding the timing and achievement of our investigational product development activities and ongoing and planned clinical trials, including initiation of new clinical trials, completion of enrollment and availability and timing for reporting of data from ongoing clinical trials; our ability to develop intra-portfolio combinations and highly-differentiated small-molecule investigational products, including our ability to create small-molecule investigational products with ideal pharmacological properties and desired clinical effects; our expectations regarding the efficiency and speed with which we can create and advance small-molecule investigational products and develop our investigational products and combination therapies; our reliance on third parties to cond

Business

Item 1. Business Company Overview We are a clinical-stage biopharmaceutical company focused on creating best-in-class therapies. Using our robust and highly efficient drug discovery capability, we have created a significant portfolio of investigational products which are in clinical development, with our most advanced molecule, an anti-TIGIT antibody, in multiple Phase 3 registrational studies targeting lung and gastrointestinal cancers. Our deep portfolio of novel small molecules and enabling antibodies allows us to create highly differentiated therapies, which we are developing to treat multiple large indications. We expect our clinical-stage portfolio to continue to expand and to include molecules targeting immuno-oncology, cancer cell-intrinsic and immunological pathways. Our vision is to create, develop and commercialize highly differentiated therapies that have a meaningful impact on patients. The below summarizes our current clinical-stage portfolio: 1 Table of Contents cas: casdatifan; chemo: chemotherapy; dom: domvanalimab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; RCC: renal cell carcinoma; rego: regorafenib; zanza: zanzalintinib; zim: zimberelimab *+/- biologic, e.g. bevacizumab or biosimilar, will be included for all patients in whom it is not contraindicated. Our Clinical Product Portfolio We currently have seven clinical programs focused on unique targets including TIGIT, PD-1, adenosine A2a and A2b receptors, CD73, CD39, HIF-2, and AXL. In 2020, we entered into an Option, License and Collaboration Agreement (as amended, the "Gilead Collaboration Agreement") with Gilead Sciences, Inc. ("Gilead") to strategically advance our portfolio through a collaborative relationship. The Gilead Collaboration Agreement provides Gilead with an exclusive license to our anti-PD-1 program (including zimberelimab) and time-limited exclusive option rights to our clinical progra

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