FibroGen Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>FibroGen Inc. has submitted its 2023 10-K annual report, detailing financial performance and business operations.</b>

AI Summary

FIBROGEN INC (KYNB) filed a Annual Report (10-K) with the SEC on February 26, 2024. FibroGen Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The filing covers the period up to December 31, 2023, with a filing date of February 26, 2024. The company is incorporated in Delaware and operates in the Pharmaceutical Preparations industry (SIC 2834). Key agreements mentioned include those with AstraZeneca, Astellas, and Eluminex. The report details various financial elements including revenue, net income, and debt.

Why It Matters

For investors and stakeholders tracking FIBROGEN INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of FibroGen's financial health and strategic activities for the fiscal year 2023, crucial for investors assessing the company's current standing and future prospects. The report contains specific details on revenue streams, expenses, and significant agreements, offering insights into the company's operational performance and potential growth drivers or risks.

Risk Assessment

Risk Level: medium — FIBROGEN INC shows moderate risk based on this filing. The company's financial performance and future prospects are subject to the inherent risks of the pharmaceutical industry, including regulatory approvals, clinical trial outcomes, and market competition, as detailed in its 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand FibroGen's performance and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-02-26 — Filing Date (FILED AS OF DATE)
• 135 — Public Document Count (PUBLIC DOCUMENT COUNT)
• 001-36740 — SEC File Number (SEC FILE NUMBER)

Key Players & Entities

• FIBROGEN INC (company) — COMPANY CONFORMED NAME
• 20231231 (date) — CONFORMED PERIOD OF REPORT
• 20240226 (date) — FILED AS OF DATE
• DE (jurisdiction) — STATE OF INCORPORATION
• 2834 (industry_code) — STANDARD INDUSTRIAL CLASSIFICATION
• AstraZeneca (company) — AstraZenecaAgreementsMember
• Astellas (company) — AstellasCollaborationAgreementMember
• Eluminex (company) — LicenseAgreementWithEluminexMember

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company's operations are subject to extensive government regulation, including the FDA, which can impact product development, approval, and marketing.
• Market Competition [medium — market]: FibroGen faces intense competition from other pharmaceutical companies, which could affect market share and pricing.
• Financing Risks [medium — financial]: The company may require additional financing to fund its ongoing operations and development programs, and such financing may not be available on favorable terms.
• Dependence on Key Personnel [low — operational]: The success of FibroGen depends significantly on its key scientific and management personnel.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-02-26: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.01 — nge on which registered Common Stock, $0.01 par value FGEN The Nasdaq Global Se
• $1.3 billion — pancreatic cancer drugs would grow from $1.3 billion in 2016 to approximately $3.7 billion i
• $3.7 billion — m $1.3 billion in 2016 to approximately $3.7 billion in 2026. The majority of patients are

Filing Documents

• fgen-20231231.htm (10-K) — 5206KB
• fgen-ex10_5.htm (EX-10.5) — 78KB
• fgen-ex10_53.htm (EX-10.53) — 26KB
• fgen-ex23_1.htm (EX-23.1) — 2KB
• fgen-ex31_1.htm (EX-31.1) — 11KB
• fgen-ex31_2.htm (EX-31.2) — 11KB
• fgen-ex32_1.htm (EX-32.1) — 7KB
• fgen-ex97_1.htm (EX-97.1) — 50KB
• img64793345_0.jpg (GRAPHIC) — 179KB
• 0000950170-24-020161.txt (&nbsp;) — 22155KB
• fgen-20231231.xsd (EX-101.SCH) — 2936KB
• fgen-20231231_htm.xml (XML) — 4467KB

Forward-Looking Statements

Forward-Looking Statements 2 Risk Factor Summary 3 China Operations and Related Risks 4 PART I 6 Item 1.

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 30 Item 1B. Unresolved Staff Comments 66 Item 1C Cybersecurity 66 Item 2.

Properties

Properties 67 Item 3.

Legal Proceedings

Legal Proceedings 68 Item 4. Mine Safety Disclosures 68 PART II 69 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 69 Item 6. [Reserved] 70 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 71 Item 7A. Quantitative and Qualitative Disclosure About Market Risks 93 Item 8. Consolidated Financial Statements and Supplementary Data 94 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 151 Item 9A.

Controls and Procedures

Controls and Procedures 151 Item 9B. Other Information 152 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 152 PART III 153 Item 10. Directors, Executive Officers and Corporate Governance 153 Item 11.

Executive Compensation

Executive Compensation 153 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 153 Item 14. Principal Accountant Fees and Services 153 PART IV 154 Item 15. Exhibits and Financial Statement Schedules 154 Item 16. Form 10-K Summary 162

Signatures

Signatures 163 1 FORWARD-LOOKIN G STATEMENTS This Annual Report on Form 10-K for the year ended December 31, 2023 ("Annual Report") and the information incorporated herein by reference, particularly in the sections captioned "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business," contains forward-looking statements, which involve substantial risks and uncertainties. In this Annual Report, all statements other than statements of historical or present facts contained in this Annual Report, including statements regarding our future financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements appear in a number of places throughout this Annual Report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for roxadustat, pamrevlumab and our other product candidates, our intellectual property position, the potential safety, efficacy, reimbursement, convenience clinical and pharmaco-economic benefits of our product candidates, the potential markets for any of our product candidates, our ability to develop commercial functions, our ability to operate in the People's Republic of China ("China"), expectations regarding clinical trial data, our results of operations, cash nee

BUSI NESS

ITEM 1. BUSI NESS OVERVIEW FibroGen, Inc. is developing and commercializing a diversified pipeline of novel therapeutics that work at the frontiers of cancer biology and anemia. In 2023, we reported results from multiple Phase 3 trials, advanced our pancreatic cancer Phase 3 trials of pamrevlumab and our preclinical work on our product candidates FG-3165 and FG-3175, in-licensed a new product candidate (FG-3246), and we continued to see robust sales growth of roxadustat in China for anemia associated with chronic kidney disease ("CKD"). In 2024, we look forward to an approval decision in China for roxadustat in chemotherapy-induced anemia ("CIA") and presenting data from two pivotal pancreatic cancer trials of pamrevlumab, our first-in-class antibody targeting connective tissue growth factor ("CTGF"). Through our new partnership with Fortis Therapeutics ("Fortis"), we are also developing FG-3246 in metastatic castrate resistant prostate cancer ("mCRPC") and potentially other cancers, and we also look forward to advancing our late-stage pre-clinical programs: our anti-Gal9 antibody FG-3165 and our anti-CCR8 antibody FG-3175. The following is an overview of our clinical, commercial, and research programs. PAMREVLUMAB FOR THE TREATMENT OF PANCREATIC CANCER Pamrevlumab is our first-in-class antibody developed to inhibit the activity of CTGF, a protein that has been shown to promote growth, survival, and spread of pancreatic tumors. To date, we have retained exclusive worldwide rights for pamrevlumab. In clinical studies involving more than 1,000 pamrevlumab-treated patients (approximately half of whom were dosed for more than six months), pamrevlumab has been well-tolerated across the range of doses studied, and there have been no dose-limiting toxicities seen thus far. The U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to pamrevlumab for the treatment of patients with locally advanced pancreatic cancer ("LAPC"). The FDA

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View this 10-K filing on SEC EDGAR