What changed in this filing

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Item 1. Financial Statements

2025-05-12 compared with 2024-11-12 · 262 added, 406 removed, 347 unchanged (66% of the section changed)

2 unchanged sentences

(In thousands, except per share amounts)

September 30, 2024

March 31, 2025

December 31, 2024

1 unchanged sentence

Cash and cash equivalents

Short-term investments

Accounts receivable, net ($ 15,534 and $ 6,079 from related parties)

Prepaid expenses and other current assets ($ 24,785 and $ 0 from a related party)

Accounts receivable, net

Prepaid expenses and other current assets

Current assets held for sale

Total current assets

Restricted time deposits

Property and equipment, net

Equity method investment in unconsolidated variable interest entity

Operating lease right-of-use assets

Long-term assets held for sale

Liabilities, redeemable non-controlling interests and deficit

Current liabilities:

Accounts payable ($ 2 and $ 0 to a related party)

Accrued and other current liabilities ($ 12,592 and $ 39,814 to a related party)

Deferred revenue ($ 6,723 and $ 7,220 to related parties)

Operating lease liabilities, current

Accounts payable

Accrued and other current liabilities

Deferred revenue

Current liabilities held for sale

Total current liabilities

Product development obligations

Deferred revenue, net of current ($ 1,388 and $ 9,705 to a related party)

Operating lease liabilities, non-current

Deferred revenue, net of current

Senior secured term loan facilities, non-current

Liability related to sale of future revenues, non-current

Other long-term liabilities ($ 559 and $ 656 to a related party)

Other long-term liabilities

Long-term liabilities held for sale

Total liabilities

Commitments and Contingencies

Commitments and Contingencies (Note 10)

Redeemable non-controlling interests

3 unchanged sentences

no shares issued

and outstanding at September 30, 2024 and December 31, 2023

and outstanding at March 31, 2025 and December 31, 2024

Common stock, $ 0.01 par value;

225,000 shares authorized at September 30, 2024

225,000 shares authorized at March 31, 2025

and December 31, 2024;

100,770 and 98,770 shares issued and outstanding at

September 30, 2024 and December 31, 2023

101,044 and 100,917 shares issued and outstanding

at March 31, 2025 and December 31, 2024

Additional paid-in capital

9 unchanged sentences

(In thousands, except per share amounts)

Three Months Ended September 30,

Nine Months Ended September 30,

License revenue

Development and other revenue (includes $ 385 , $ 2,358 , $ 997

and $ 5,821 from a related party)

Product revenue, net (includes $ 42,221 , $ 26,463 , $ 115,339 and $ 68,347

from a related party)

Drug product revenue, net (includes $( 262 ), $ 1,320 , $( 717 ) and $ 17,701

from a related party)

Three Months Ended March 31,

Development and other revenue

Drug product revenue, net

Total revenue

10 unchanged sentences

Total interest and other, net

Loss before income taxes

Provision for (benefit from) income taxes

Investment income in unconsolidated variable

interest entity

Net loss per share - basic and diluted

Loss from continuing operations before income taxes

Provision for income taxes

Loss from continuing operations

Income from discontinued operations, net of tax

Net income (loss)

Loss from continuing operations per share - basic and diluted

Income from discontinued operations per share - basic and diluted

Net income (loss) per share - basic and diluted

Weighted average number of common shares used to calculate

net loss per share - basic and diluted

net income (loss) per share - basic and diluted

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE LOSS

CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Net income (loss)

Other comprehensive income (loss):

1 unchanged sentence

Available-for-sale investments:

Unrealized gain (loss) on investments, net of tax effect

Other comprehensive gain (loss), net of taxes

Comprehensive loss

Unrealized loss on investments, net of tax effect

Other comprehensive gain, net of taxes

Comprehensive income (loss)

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENT S OF CHANGES IN STOCKHOLDERS’ DEFICIT

CONDENSED CONSOLIDATED STATEMENT S OF CHANGES IN REDEEMABLE NON-CONTROLLING

INTERESTS AND STOCKHOLDERS’ DEFICIT

(In thousands, except share data)

5 unchanged sentences

Income (Loss)

June 30, 2024

Change in unrealized gain or

loss on investments

Foreign currency translation

Shares issued from stock

plans, net of payroll taxes

Stock-based compensation

September 30, 2024

Balance at June 30,

Change in unrealized gain or

loss on investments

Foreign currency translation

Shares issued from stock

plans, net of payroll taxes

Stock-based compensation

September 30, 2023

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

(In thousands, except share data)

For The Nine Month Period

Comprehensive

Nonredeemable

Non-Controlling

December 31, 2024

Change in unrealized gain

or loss on investments

Change in unrealized

gain or loss on

Foreign currency

translation adjustments

Shares issued from stock

plans, net of payroll

Stock-based compensation

September 30, 2024

Issuance cost under

March 31, 2025

December 31, 2023

Consolidation of Fortis

Change in unrealized gain

or loss on investments

Change in unrealized

gain or loss on

Foreign currency

translation adjustments

Issuance of common stock

under ATM Program

Shares issued from stock

plans, net of payroll

Stock-based compensation

September 30, 2023

Balance at March 31,

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

2 unchanged sentences

(In thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Operating activities

Adjustments to reconcile net loss to net cash used in operating activities:

Net income (loss)

Adjustments to reconcile net income (loss) to net cash provided by (used in)

operating activities:

Amortization of finance lease right-of-use assets

Net accretion of premium and discount on investments

Investment income in unconsolidated variable interest entity

Loss on disposal of property and equipment

Investment loss (income) in unconsolidated variable interest entity

Stock-based compensation

Acquired in-process research and development expenses

Non-cash interest expense related to sale of future revenues

Dividend received from unconsolidated variable interest entity

Impairment of investment

Realized loss on sales of available-for-sale securities

Changes in operating assets and liabilities:

5 unchanged sentences

Operating lease liabilities, current

Deferred revenue

Deferred revenues

Accrued interest expense related to sale of future revenues

2 unchanged sentences

Other long-term liabilities

Net cash used in operating activities

Net cash provided by (used in) operating activities

Investing activities

Purchases of property and equipment

Proceeds from sale of property and equipment

Purchases of available-for-sale securities

Cash acquired from consolidation of Fortis

Proceeds from sales of available-for-sale securities

Proceeds from maturities of investments

Net cash provided by investing activities

Net cash provided by (used in) investing activities

Financing activities

Proceeds from senior secured term loan facilities, net of issuance costs

Cash paid for transaction costs for senior secured term loan facilities

Repayments of finance lease liabilities

Repayments of lease obligations

Cash paid for payroll taxes on restricted stock unit releases

Proceeds from issuance of common stock under ATM Program, net of commissions

Proceeds from issuance of common stock under employee stock plans

Net cash provided by (used in) financing activities

Payment of issuance cost under ATM Program

Net cash used in financing activities

Effect of exchange rate change on cash and cash equivalents

8 unchanged sentences

FibroGen, Inc.

(“FibroGen” or the “Company”) is headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”).

FibroGen is developing and commercializing a diversified pipeline of novel therapeutics that work at the frontier of cancer biology and anemia.

Roxadustat is an oral small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase activity.

Roxadustat (爱瑞卓 ® , EVRENZO TM ) is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease for patients who are on dialysis and not on dialysis.

Roxadustat is in clinical development for chemotherapy-induced anemia in China.

FG-3246 is a first-in-class antibody-drug conjugate targeting a novel epitope on CD46 that is in development for metastatic castration-resistant prostate cancer and other cancer indications.

FibroGen also has a pipeline of preclinical product candidates, FG-3165 and FG-3175, to address unmet patient needs in oncology.

(“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.

The Company is developing FG-3246, a potential first-in-class antibody-drug conjugate (“ADC”) targeting CD46, for the treatment of metastatic castration-resistant prostate cancer (“mCRPC”) and potentially other cancers.

This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent.

The Company anticipates initiation of a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory analysis of FG-3180, in the third quarter of 2025.

The Company and its collaboration partners have developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in the People’s Republic of China (“China”), Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.

On February 20, 2025, the Company entered into a share purchase agreement (the “Share Purchase Agreement”) with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.

agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd.

(“FibroGen International”) to AstraZeneca Treasury Limited.

AstraZeneca AB (“AstraZeneca”) is the Company’s long-time commercialization partner for roxadustat in greater China and South Korea.

This sale includes all of FibroGen’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1 % interest in Beijing Falikang Pharmaceutical Co.

Ltd (“Falikang”).

The transaction is expected to close in the third quarter of 2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.

FibroGen has retained the rights to roxadustat in the United States of America (“U.S.”), Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc.

(“Astellas”).

Roxadustat is not approved for commercialization in any indication in the U.S., Canada, or Mexico.

Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements:

one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.

The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need.

Basis of Presentation and Principles of Consolidation

The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S.

GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S.

Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements.

The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 17, 2025.

The condensed consolidated financial statements include the accounts of FibroGen, its wholly-owned subsidiaries and its majority-owned subsidiaries, as well as any variable interest entity (“VIE”) for which FibroGen is the primary beneficiary.

All inter-company transactions and balances have been eliminated in consolidation.

For any VIE for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting.

The Company operates as one reportable segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs.

The Company operates as one reportable segment — the development and commercialization of novel therapeutics to treat serious unmet medical needs.

Discontinued Operations

On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.

agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited for an aggregate purchase price comprised of $ 85 million in cash for the enterprise value of FibroGen International, plus an additional cash amount equal to the net cash held in China by FibroGen International and its subsidiaries as of the closing.

The Company analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in FibroGen’s business and qualified as a discontinued operation.

As a result, the Company determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with Financial Accounting Standard Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements , as of March 31, 2025 and December 31, 2024.

Accordingly, the condensed consolidated balance sheets and the condensed consolidated statements of operations, and the notes to the condensed consolidated financial statements were recasted for all periods presented to reflect the discontinuation of FibroGen International in accordance with ASC 205.

The operating results related to FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations, while the related assets and liabilities were classified within the condensed consolidated balance sheets as held for sale for all periods presented.

See Note 2, Discontinued Operations , for related disclosures.

Unless otherwise noted, discussion in the notes to these consolidated financial statements, relates to solely to the Company’s continuing operations.

Liquidity and Going Concern

The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S.

GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements.

The unaudited condensed consolidated financial statements are prepared in accordance with the U.S.

GAAP applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described below.

If the Company is unable to repatriate additional cash from its China operations or raise additional capital in the U.S., within the next 12 months, the Company would not be able to comply with its debt covenants under its senior secured term loan facilities that requires a minimum balance of $ 30 million of unrestricted cash and cash equivalents to be held in accounts in the U.S.

Upon an event of default, the Company’s senior secured term loan facilities would become immediately due and payable.

The Company continues to evaluate measures to repatriate additional cash from its China operations.

If the Company is unable to complete the above mentioned sale of FibroGen International, access additional cash from its China operations, or raise additional capital in the United States, the Company would not have sufficient liquidity to continue operations in the U.S.

for the 12 months from the date that the financial statements are issued and would not be able to comply with its financial covenant that requires a minimum balance of $ 27 million of unrestricted cash and cash equivalents to be held in accounts in the United States.

Upon an event of default, the Company’s senior secured term loan facilities could become immediately due and payable.

The Company has evaluated measures to access additional cash from its China operations and believes the sale of FibroGen International represents the most efficient way to access the entirety of its cash from China upon closing of the transaction.

There is also the potential that the Company raises additional funds in the U.S.

1 unchanged sentence

There can be no assurances that these plans will be successful.

As a result of these factors, the Company determined that there is substantial doubt about the Company’s ability to continue as a going concern within 12 months after the date that the financial statements are issued .

As a result of these factors, the Company has determined that there is substantial doubt about its ability to continue as a going concern within 12 months after the date that the financial statements are issued.

Use of Estimates

6 unchanged sentences

Significant Accounting Policies

The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on February 26, 2024.

Net Loss per Share

Net Income (Loss) per Share

Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share.

The Company reported a net loss for each of the three and nine months ended September 30, 2024 and 2023.

The Company reported a loss from continuing operations for each of the three months ended March 31, 2025 and 2024.

Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive for these periods.

Diluted weighted average shares excluded the following potential common shares related to s tock options, service-based restricted stock units (“RSUs”), performance-based RSUs (“PRSUs”), total shareholder return (“TSR”) awards and shares to be purchased under the 2014 Employee Stock Purchase Plan (“ESPP”) for the periods presented as they were anti-dilutive (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Employee stock options

4 unchanged sentences

Recently Issued Accounting Guidance Not Yet Adopted

In November 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.

2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses.

In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), and relevantly in January 2025, the FASB issued ASU 2025-01 , Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures ( Subtopic 220-40 ):

Clarifying the Effective Date.

The guidance requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses.

This guidance is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted.

1 unchanged sentence

The Company is currently in the process of evaluating the effects of this guidance on its related disclosures.

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance.

In addition, this guidance requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.

This guidance is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024, with retrospective application required, and early adoption permitted.

The Company is currently in the process of evaluating the effects of this guidance on its related disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

2 unchanged sentences

The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.

Discontinued Operations

On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited, pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.

This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1 % interest in Falikang.

As a result, Company determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with FASB ASC 205, Presentation of Financial Statements , as of March 31, 2025 and December 31, 2024.

Accordingly, the operating results related to the FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations, while the related assets and liabilities were classified within the condensed consolidated balance sheets as held for sale for all periods presented.

The financial results of the discontinued operations with respect to FibroGen International reflected in the condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024 were as follows (in thousands):

Three Months Ended March 31,

Product revenue, net

Operating costs and expenses:

Cost of goods sold

Research and development

Selling, general and administrative

Total operating costs and expenses

Income from operations

Interest and other, net

Interest expense

Interest income and other income (expenses), net

Total interest and other, net

Income before income taxes

Provision for income taxes

Investment income (loss) in unconsolidated variable interest entity

Income from discontinued operations, net of tax

The product revenue, net, consists primarily of revenues from sales of roxadustat commercial product to Falikang, a distribution entity jointly owned by AstraZeneca and FibroGen Beijing, and is discussed in the China Performance Obligation section in Note 3, Collaboration Agreements, License Agreement and Revenues .

The carrying value of the assets and liabilities of the discontinued operations with respect to FibroGen International on the condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024 were as follows (in thousands):

March 31, 2025

December 31, 2024

Cash and cash equivalents

Accounts receivable, net

Prepaid expenses and other current assets

Total current assets held for sale

Property and equipment, net

Equity method investment in unconsolidated variable interest entity

Operating lease right-of-use assets

Total long-term assets held for sale

Accounts payable

Accrued and other current liabilities

Operating lease liabilities, current

Total current liabilities held for sale

Operating lease liabilities, non-current

Total long-term liabilities held for sale

The significant non-cash items and capital expenditures for the discontinued operations with respect to FibroGen International included in the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 were as follows (in thousands):

Three Months Ended March 31,

Investment loss (income) in unconsolidated variable interest entity

Stock-based compensation

Included in the discontinued operations, Falikang, an entity jointly owned by FibroGen Beijing and AstraZeneca is an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company.

FibroGen Beijing owns 51.1 % of Falikang’s equity.

For the three months ended March 31, 2025 and 2024, the net product revenue from sales to Falikang were $ 36.9 million and $ 27.1 million , respectively.

The other income from Falikang were immaterial for the three months ended March 31, 2025 and 2024.

For the three months ended March 31, 2025 and 2024, the investment income (loss) in Falikang was $( 0.6 ) million and $ 0.6 million, respectively.

As of March 31, 2025 and December 31, 2024, the Company’s equity method investment in Falikang were $ 6.4 million and $ 6.9 million, respectively, which were included in the long-term assets held for sale on the condensed consolidated balance sheets.

As of March 31, 2025 and December 31, 2024, accounts receivable, net, from Falikang were $ 18.7 million and $ 13.9 million, respectively, which were included in the current assets held for sale on the condensed consolidated balance sheets.

Collaboration Agreements, License Agreement and Revenues

5 unchanged sentences

The Astellas Japan Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range of the list price published by Japan’s Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch.

The aggregate amount of consideration received through September 30, 2024 totaled $ 105.1 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below.

The aggregate amount of consideration received under the Astellas Japan Agreement through March 31, 2025 totaled $ 105.1 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below.

Based on its current development plans for roxadustat in Japan, the Company does not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement.

Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were not material for the three and nine months ended September 30, 2024 and 2023.

The transaction price related to consideration received through September 30, 2024 and accounts receivable has been allocated to each of the performance obligations under the Astellas Japan Agreement, including $ 100.3 million for license and $ 17.1 million for co-development.

There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended September 30, 2024 under the Astellas Japan Agreement.

Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were no t material for the three months ended March 31, 2025 and 2024.

The transaction price related to consideration received through March 31, 2025 and accounts receivable has been allocated to each of the performance obligations under the Astellas Japan Agreement, including $ 100.3 million for license and $ 17.1 million for co-development.

The Company does no t expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Astellas Japan Agreement.

6 unchanged sentences

The Astellas Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range .

The aggregate amount of consideration received under the Astellas Europe Agreement through September 30, 2024 totaled $ 685.0 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below.

The aggregate amount of consideration received under the Astellas Europe Agreement through March 31, 2025 totaled $ 685.0 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below.

Based on its current development plans for roxadustat in Europe, the Company does not expect to receive most or all of the additional potential milestones under the Astellas Europe Agreement.

Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were as follows for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Performance Obligation

Astellas Europe Agreement

Development revenue

The transaction price related to consideration received through September 30, 2024 and accounts receivable has been allocated to each of the performance obligations under the Astellas Europe Agreement, including $ 619.0 million for license and $ 287.7 million for co-development.

There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for three months ended September 30, 2024 under the Astellas Europe Agreement.

The Company does not expect material variable consideration from estimated future co-development billing beyond the development period in the transaction price related to the Astellas Japan Agreement.

Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were no t material for the three months ended March 31, 2025 and 2024.

The transaction price related to consideration received through March 31, 2025 and accounts receivable has been allocated to each of the performance obligations under the Astellas Europe Agreement, including $ 619.0 million for license and $ 288.3 million for co-development.

There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for three months ended March 31, 2025 under the Astellas Europe Agreement.

In 2021, the Company entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement (“Astellas EU Supply Agreement”) to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies.

2 unchanged sentences

AstraZeneca U.S./Rest of World (“RoW”) Agreement

Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB (“AstraZeneca”) for the development and commercialization of roxadustat for the treatment of anemia in the U.S.

Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S.

and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“AstraZeneca U.S./RoW Agreement”).

5 unchanged sentences

In addition, resulting from the AstraZeneca Termination and Transition Agreement, the Company and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement.

Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”) and recorded a cumulative catch-up adjustment as described under the Drug Product Revenue, Net section below.

Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the ASC 606, Revenue from Contracts with Customers (“ASC 606”) and recorded a cumulative catch-up adjustment as described under the Drug Product Revenue, Net section below.

The Company’s collaboration agreement with AstraZeneca for roxadustat in China, as described below, remains in place.

3 unchanged sentences

The AstraZeneca China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the AstraZeneca China Amendment as defined and discussed below, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period.

The aggregate amount of such consideration received for milestone and upfront payments through September 30, 2024 totaled $ 77.2 million .

On September 18, 2023, the Company received the formal notice, from Beijing Medical Products Administration, of renewal of its right to continue to market roxadustat in China through 2028.

The Company evaluated the regulatory milestone payment associated with this renewal under the AstraZeneca China Agreement and concluded that this milestone was achieved in the third quarter of 2023.

Accordingly, the consideration of $ 4.0 mi llion associated with this milestone was included in the transaction price in the third quarter of 2023 and allocated to performance obligations under the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement and was unbilled as of December 31, 2023, recorded as a contract asset and fully netted against the contract liabilities (deferred revenue) related to the AstraZeneca China Agreement.

During the three months ended September 30, 2024 , based on the arrangements under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items, the $ 4.0 million milestone was billed and included in the accounts receivable as of September 30, 2024.

The aggregate amount of such consideration received for milestone and upfront payments through March 31, 2025 totaled $ 81.2 million .

AstraZeneca China Amendment

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(“FibroGen Beijing”), FibroGen International (Hong Kong) Limited, and AstraZeneca entered into an amendment to the AstraZeneca China Agreement, relating to the development and commercialization of roxadustat in China (the “AstraZeneca China Amendment”).

Under the AstraZeneca China Amendment, in 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Beijing Falikang Pharmaceutical Co., Ltd.

(“Falikang”), which performs roxadustat distribution, as well as conducts sales and marketing through AstraZeneca.

Under the AstraZeneca China Amendment, in 2020, FibroGen Beijing and AstraZeneca completed the establishment of a jointly owned entity, Falikang, which performs roxadustat distribution, as well as conducts sales and marketing through AstraZeneca.

Substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in limited areas in China.

FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transfer price, which is adjusted for the estimated profit share.

The net product revenue from the sales to Falikang and the net product revenue from direct sales distributors in China are described under Product Revenue, Net section below.

Further discussion related to the sales to Falikang is discussed under the China Performance Obligation section below.

The related net product revenue recognized from the sales to Falikang was $ 36.9 million and $ 27.1 million for the three months ended March 31, 2025 and 2024, respectively, and were included in the discontinued operations in the condensed consolidated statements of operations together with the sales directly to distributors, resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited as discussed in Note 2, Discontinued Operations .

Prior to the above-mentioned termination of the AstraZeneca U.S./RoW Agreement, the Company evaluated under the ASC 606 and accounted for the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement.

As a result of the termination of the AstraZeneca U.S./RoW Agreement, during the three months ended March 31, 2024, the Company recorded the final development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement.

Amounts recognized as license revenue and development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement were as follows for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Performance Obligation

AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement

License revenue

Development revenue

The transaction price related to consideration received and accounts receivable through the termination of the AstraZeneca U.S./RoW Agreement has been allocated to each of the performance obligations under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, including $ 344.5 million for license, $ 625.5 million for co-development, information sharing and committee services, and $ 458.1 million for China performance obligation (with cumulative revenue of $ 311.1 million through September 30, 2024) that is recognized as product revenue, as described under Product Revenue, Net section below.

Product Revenue, Net

Product revenue, net from the sales of roxadustat commercial product in China was as follows for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Direct Sales:

Gross revenue

Discounts and rebates

Sales returns

Direct sales revenue, net

Sales to Falikang:

Gross transaction price

Net transaction price

Decrease in deferred revenue

Sales to Falikang revenue, net

Total product revenue, net

Product revenue from direct roxadustat product sales to distributors in China is recognized in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those products, net of various sales rebates and discounts.

The total discounts and rebates were immaterial for the periods presented.

Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash.

The Company’s legal right to offset is determined at the individual distributor level.

The contract liabilities were included in accrued and other current liabilities in the condensed consolidated balance sheet and the rebates and discounts reflected as reductions to gross accounts receivable for direct sales were immaterial as of September 30, 2024 and December 31, 2023, respectively.

Sales to Falikang – China Performance Obligation

The transaction price related to consideration received and accounts receivable through the termination of the AstraZeneca U.S./RoW Agreement has been allocated to each of the performance obligations under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, including $ 344.5 million for license, $ 625.5 million for co-development, information sharing and committee services, and $ 522.5 million for China performance obligation (with cumulative revenue of $ 391.7 million through March 31, 2025) that is recognized as product revenue, net included in discontinued operations as described under China Performance Obligation section below.

China Performance Obligation

Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.

Substantially all direct roxadustat product sales to distributors in China are made by Falikang.

FibroGen Beijing manufactures and supplies commercial product to Falikang.

The net transfer price for FibroGen Beijing’s product sales to Falikang is based on a gross transaction price, which is adjusted to account for the 50/50 profit share for the period.

The net transaction price for FibroGen Beijing’s product sales to Falikang is based on a gross transaction price, adjusted for the estimated profit share.

The roxadustat sales to Falikang marked the beginning of the Company’s China performance obligation under the Company’s agreements with AstraZeneca .

Product revenue is based on the transaction price of the China performance obligation.

Revenue is recognized when control of the product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period, and is expected to continue through 2033, which reflects our best estimates.

Periodically, the Company updates its assumptions such as total sales quantity, performance period, gross transaction price, profit share and other inputs including foreign currency translation impact, among others.

Any net transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized in future periods as the performance obligation is satisfied.

Periodically, the Company updates its assumptions such as gross transaction price and profit share, performance period, total sales quantity and other inputs including foreign currency translation impact, among others.

Following updates to its estimates, the Company recognized $ 12.5 million and $ 33.1 million from the previously deferred revenue of the China performance obligation for the three and nine months ended September 30, 2024, respectively.

The product revenue recognized for the three months ended September 30, 2024 included an increase in revenue of $ 4.5 million resulting from changes to estimated variable consideration in the current period relating to performance obligation satisfied in previous periods.

Comparatively, following updates to its estimates, the Company recognized $ 2.3 million and $ 1.1 million from the previously deferred revenue of the China performance obligation for the three and nine months ended September 30, 2023, respectively.

While the related product revenue recognized is included in discontinued operations, as of March 31, 2025 and December 31, 2024, the related deferred revenues were not included in the disposal group held for sale as the related obligation to AstraZeneca will be satisfied upon the closing of the divestiture FibroGen International.

The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands):

December 31, 2024

Recognized as Revenue

September 30, 2024

Product revenue - AstraZeneca China

performance obligation - deferred revenue

(Discontinued

March 31, 2025

AstraZeneca China performance obligation

- deferred revenue

Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca.

Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the condensed consolidated balance sheets.

As of September 30, 2024, deferred revenue included $ 147.0 million related to China performance obligation.

As of September 30, 2024 , approximately $ 22.1 million of the above deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China.

Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts, mainly related to profit sharing, are presented as reductions to gross accounts receivable from Falikang, which was immaterial as of September 30, 2024 and was $ 3.0 million as of December 31, 2023.

As of March 31, 2025 , approximately $ 15.5 million of the above deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China.

Drug Product Revenue, Net

Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three months ended March 31, 2025 and 2024 (in thousands):

Three Months Ended March 31,

Astellas Japan Agreement

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The Company updates its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment at each balance sheet date.

As a result, the Company recorded a reduction to the drug product revenue of $ 1.4 million for the three months ended September 30, 2024.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, among others.

For the three months ended June 30, 2024, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $ 0.4 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect foreign exchange impacts and the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, among others.

As a result, the Company recorded an adjustment to the drug product revenue of $ 1.8 million for the three months ended March 31, 2025.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated yield from the manufacture of bulk product tablets, among others.

For the three months ended March 31, 2024, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $ 2.2 million.

During the three months ended September 30, 2023, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $ 0.7 million.

During the three months ended June 30, 2023, the Company fulfilled two shipment obligations under the terms of Astellas Japan Amendment and recognized related drug product revenue of $ 14.4 million in the same period.

In addition, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded a reduction to the drug product revenue of $ 0.6 million.

During the three months ended March 31, 2023, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $ 1.7 million.

As of September 30, 2024, t he balances related to the API price true-up under the Astellas Japan Agreement were $ 3.6 million in accrued liabilities and $ 0.6 million in other long-term liabilities, representing the Company’s best estimate of the timing for these amounts to be paid.

As of March 31, 2025, t he balances related to the API price true-up under the Astellas Japan Agreement were $ 0.7 million in accrued liabilities and $ 0.6 million in other long-term liabilities, representing the Company’s best estimate of the timing for these amounts to be paid.

As of December 31, 2024, the balances related to the API price true-up under the Astellas Japan Agreement were $ 2.5 million in accrued liabilities and $ 0.6 million in other long-term liabilities.

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As of December 31, 2024, the related balance in accrued liabilities was $ 10.5 million.

The Company further reclassified $ 5.6 million from the related deferred revenue to accrued liabilities and paid $ 35.3 million to Astellas during the nine months ended September 30, 2024.

As of September 30, 2024, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $ 9.0 million in a ccrued liabilities, representing the Company’s best estimate that these amounts will be paid within the next 12 months.

The Company recognized royalty revenue of $ 1.1 million and $ 0.6 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement during the three months ended September 30, 2024 and 2023, and $ 3.2 million and $ 1.5 million for the nine months ended September 30, 2024 and 2023, respectively.

Further for the three months ended March 31, 2025, the Company reclassified $ 2.1 million from the related deferred revenue to accrued liabilities.

As of March 31, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $ 12.6 million in a ccrued liabilities, representing the Company’s best estimate that these amounts will be paid within the next 12 months.

The Company recognized royalty revenue of $ 0.8 million and $ 1.0 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement during the three months ended March 31, 2025 and 2024, respectively.

It is the Company’s best estimate that the remainder of the deferred revenue will be recognized as revenue when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.

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Reclassified to Accrued Liability / Accounts Payable

September 30, 2024

March 31, 2025

Drug product revenue - deferred revenue:

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As described under AstraZeneca Agreements section above, pursuant to the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, the Company and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement.

Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $ 25.7 million to the drug product revenue.

The related accounts receivable of $ 26.0 million and the related accrued liabilities of $ 11.5 million as of March 31, 2024 were settled during the second quarter of 2024.

Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $ 25.7 million to the drug product revenue and received the cash during the second quarter of 2024.

Corresponding to the drug product revenue, during the three months ended March 31, 2024, the Company recorded the related cost of goods sold of $ 21.1 million.

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In July 2021, FibroGen exclusively licensed to Eluminex Biosciences (Suzhou) Limited (“Eluminex”) global rights to its investigational biosynthetic cornea derived from recombinant human collagen Type III.

Under the terms of the agreement with Eluminex, as amended and restated in January 2022, Eluminex made an $ 8.0 million upfront payment to FibroGen during the first quarter of 2022.

In addition, FibroGen may receive up to a total of $ 64.0 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $ 36.0 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea.

FibroGen will also be eligible to receive mid-single-digit to low double-digit royalties based upon worldwide net sales of cornea products, and low single-digit to mid-single-digit royalties based upon worldwide net sales of other recombinant human collagen type III products that are not cornea products.

FibroGen may receive up to a total of $ 64.0 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $ 36.0 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea.

FibroGen will be eligible to receive mid-single-digit to low double-digit royalties based upon worldwide net sales of cornea products, and low single-digit to mid-single-digit royalties based on worldwide net sales of other recombinant human collagen type III products that are not cornea products.

In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed).

The A&R Eluminex Agreement included additional total upfront payments of $ 1.5 million.

During the first quarter of 2023, the Company recognized a $ 3.0 million milestone payment based on Eluminex implanting a biosynthetic cornea in the first patient of its clinical trial in China, and a $ 3.0 million manufacturing related milestone payment.

During the second quarter of 2023, the Company recognized a $ 1.0 million upfront payment under the A&R Eluminex Agreement.

During the third quarter of 2023, the Company recognized a $ 0.5 million upfront payment related to patent transfer under the A&R Eluminex Agreement.

The Company received an $ 8.0 million upfront payment from Eluminex in 2022 and thereafter recognized a total of $ 6.0 million milestone payments and a total of $ 1.5 million upfront payment in 2023.

During the first quarter of 2022, FibroGen and Eluminex entered into a separate contract manufacturing agreement, under which the Company is responsible for supplying the cornea product at cost plus 10 % of its product manufacturing costs until its manufacturing technology is fully transferred to Eluminex, which occurred by the end of 2023 .

The related contract manufacturing revenue was recorded as other revenue and included in development and other revenue in the condensed consolidated statement of operations.

Such contract manufacturing activity was generally ceased during the first quarter of 2024.

Amounts recognized as revenue under the agreements with Eluminex were as follows for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Performance Obligation

License revenue

Other revenue - contract manufacturing

Other revenue - patent transfer

As part of its continuing efforts to reduce operating expenses and preserve cash, on September 27, 2024, the Company entered into an Agreement for Termination of Lease and Voluntary Surrender of Premises (“ Lease Termination Agreement ”) with its landlord, ARE-San Francisco No.43 Owner, LLC (“ARE”) related to the Company’s operating lease of its corporate headquarters in San Francisco, California.

The Lease Termination Agreement modifies the lease agreement dated as of September 22, 2006, as subsequently amended and accelerates the expiration date of the term of the Lease from 2028 to no later than December 31, 2024.

Pursuant to the Lease Termination Agreement, the Company paid ARE a total consideration of $ 10.0 million settlement amount, consisting of a $ 8.3 million, paid before September 30, 2024, of a one-time cash payment by FibroGen for past rent, FibroGen’s share of operating costs, taxes, insurance, utilities, and other costs and a lease modification payment;

and a $ 1.7 million security deposit, in the form of a letter of credit, drawn in early October 2024.

As of execution of this Lease Termination Agreement, FibroGen is not responsible for the payment of any further rent payments or operating costs, taxes, insurance, utilities, or any other scheduled monthly payments due under the lease to ARE.

The Company ceased the use of the underlying operating lease right-of-use asset by September 30, 2024.

As a result, as of September 30, 2024, the Company derecognized the related operating lease right-of-use asset of $ 56.1 million and operating lease liabilities of $ 68.5 million, and recorded an approximately $ 1.7 million gain as credits to the selling, general and administrative expenses for the three months ended September 30, 2024.

The remaining operating leases of $ 2.1 million as of September 30, 2024 are mainly associated with the real estate leases for office spaces in Shanghai and Beijing, China, expiring between 2025 and 2027 .

Variable Interest Entities

There was no revenue recognized under the agreements with Eluminex for the three months ended March 31, 2025.

Amounts recognized as revenue under the agreements with Eluminex were immaterial for the three months ended March 31, 2024 .

Consolidated Variable Interest Entity - Fortis

On May 5, 2023 (the “Option Acquisition Date”), the Company entered into an exclusive option agreement to acquire Fortis Therapeutics, Inc.

In May 2023 (the “Option Acquisition Date”), the Company entered into an exclusive option agreement to acquire Fortis Therapeutics, Inc.

(“Fortis”) with its novel Phase 1 antibody-drug conjugate, FOR46 (now referred to as “FG-3246”), that targets a novel epitope on CD46 preferentially expressed on certain cancer cells.

FG-3246 is in development for the treatment of metastatic castration-resistant prostate cancer with potential applicability in other solid tumors and hematologic malignancies.

FG-3246 is in development for the treatment of mCRPC with potential applicability in other solid tumors and hematologic malignancies.

If FibroGen exercises the option to acquire Fortis, it will pay Fortis an option exercise payment of $ 80.0 million, and thereafter, legacy Fortis shareholders would be eligible to receive from FibroGen up to $ 200.0 million in contingent payments associated with the achievement of various regulatory approvals.

If FibroGen acquires Fortis, it would also be responsible to pay the University of California, San Francisco, an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the licensing arrangement between Fortis and University of California, San Francisco .

If FibroGen acquires Fortis, it would also be responsible to pay University of California, San Francisco (“UCSF”), an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the licensing arrangement between Fortis and UCSF .

If FibroGen chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.

Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement (together the “Fortis Agreements”), FibroGen has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by FibroGen, and manufacturing of FG-3246 during the up-to four-year option period.

As part of the clinical development strategy, FibroGen will continue the work to develop a positron emission tomography (“PET”)-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection.

On March 28, 2025, the Company and Fortis entered into amendments and modified the option exercise deadline to December 31, 2027.

Food and Drug Administration for the purpose of progressing to a Phase 3 clinical trial or December 31, 2027 absent extension).

As part of the clinical development strategy, FibroGen will continue the work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection.

Additionally, the Company is obligated to make four quarterly payments totaling $ 5.4 million to Fortis in support of its continued development obligations, of which the last payment was $ 1.7 million and made during the three months ended March 31, 2024.

Pursuant to the guidance under ASC 810, Consolidation (“ASC 810”), the Company determined that Fortis is a VIE and that the Company is the primary beneficiary of Fortis, as through the Fortis Agreements the Company has the power to direct activities that most significantly impact the economic performance of Fortis.

Therefore, the Company consolidated Fortis starting from the Option Acquisition Date and continues to consolidate as of September 30, 2024.

Therefore, the Company consolidated Fortis starting from the Option Acquisition Date and continues to consolidate as of March 31, 2025.

Fortis has authorized and issued common shares and Series A preferred shares.

As of the Option Acquisition Date and September 30, 2024 , the Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired previously and carried at zero cost.

As of the Option Acquisition Date and March 31, 2025 , the Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired previously and carried at zero cost.

The non-controlling interests (“NCI”) attributable to the common shares is classified as nonredeemable NCI, as it is 100 % owned by third party shareholders.

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Fortis’ net loss is allocated to its common shares only as the holders of preferred shares do not have a contractual obligation to absorb such losses.

As of September 30, 2024, total assets and liabilities of Fortis were immaterial.

For the three and nine months ended September 30, 2024, Fortis’ net income (losses) was immaterial.

Equity method investment - Unconsolidated VIE - Falikang

Falikang is a distribution entity jointly owned by AstraZeneca and FibroGen Beijing.

FibroGen Beijing owns 51.1 % of the outstanding shares of Falikang.

Pursuant to the guidance under ASC 810, the Company concluded that Falikang qualifies as a VIE.

As Falikang is a distribution entity and AstraZeneca is the final decision maker for all the roxadustat commercialization activities, the Company lacks the power criterion, while AstraZeneca meets both the power and economic criteria under the ASC 810 to direct the activities of Falikang that most significantly impact its performance.

Therefore, the Company is not the primary beneficiary of this VIE for accounting purposes.

As a result, the Company accounts for its investment in Falikang under the equity method, and Falikang is not consolidated into the Company’s condensed consolidated financial statements.

The Company records its total investments in Falikang as an equity method investment in an unconsolidated VIE in the condensed consolidated balance sheet.

In addition, the Company recognizes its proportionate share of the reported profits or losses of Falikang as investment gain or loss in unconsolidated VIE in the condensed consolidated statement of operations and as an adjustment to its investment in Falikang in the condensed consolidated balance sheet.

During the three months ended September 30, 2024, the Company received $ 2.2 million of dividend distribution from Falikang.

The Company may provide shareholder loans to Falikang to meet necessary financial obligations as part of its operations.

To date, there have been no such loans.

The Company’s equity method investment in Falikang was as follows (in thousands):

Ownership Percentage

December 31, 2023

Share of Net Income

Dividend Received

September 30, 2024

Falikang is considered a related party to the Company.

See Note 10, Related Party Transactions , for related disclosures.

As of March 31, 2025, total assets and liabilities of Fortis were immaterial.

For the three months ended March 31, 2025 , Fortis’ net income (losses) was immaterial.

Fair Value Measurements

The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):

September 30, 2024

March 31, 2025

Money market funds

Commercial paper

government bonds

December 31, 2024

Money market funds

Corporate bonds

Commercial paper

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These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs.

There were no transfers of assets between levels during the three months ended September 30, 2024 and June 30, 2024.

During the three months ended March 31, 2024, a total of $ 26.3 million of U.S.

During the three months ended March 31, 2025 and 2024 , a total of $ 6.5 million and $ 26.3 million, respectively, of U.S.

treasury notes and bills were transferred from Level 1 to Level 2 as such instruments were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day.

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Cash and cash equivalents consisted of the following (in thousands):

September 30, 2024

March 31, 2025

December 31, 2024

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Total cash and cash equivalents

At September 30, 2024 and December 31, 2023, a total of $ 51.0 million and $ 32.2 million of the Company’s cash and cash equivalents were held outside of the U.S.

in its foreign subsidiaries to be used primarily for its China operations, respectively.

The Company did no t have any short-term or long-term investments as of September 30, 2024.

As of December 31, 2023, t he Company’s investments consist primarily of available-for-sale debt investments, and the amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands):

December 31, 2023

Amortized Cost

Gross Unrealized

Holding Gains

Gross Unrealized

Holding Losses

Corporate bonds

Commercial paper

government bonds

Total investments

The following table summarizes, for all available for sale securities in an unrealized loss position as of December 31, 2023, the fair value and gross unrealized loss by length of time the security has been in a continual unrealized loss position (in thousands):

December 31, 2023

Less than 12 Months

12 Months or More

Gross Unrealized

Holding Losses

Gross Unrealized

Holding Losses

Gross Unrealized

Holding Losses

Corporate bonds

government bonds

The Company periodically assesses whether the unrealized losses on its available-for-sale investments were temporary.

The Company considers factors such as the severity and the reason for the decline in value, the potential recovery period and its intent to sell.

For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses.

Based on the results of its review, the Company did no t recognize any impairment for its available-for-sale investments during the three and nine months ended September 30, 2024 and 2023.

Inventories consisted of the following (in thousands):

September 30, 2024

December 31, 2023

Raw materials

Work-in-progress

Finished goods

Total inventories

As described under Note 2, Collaboration Agreements, License Agreement and Revenues above, resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, the Company was reimbursed $ 12.6 million for work-in-progress inventory, which was written off and recognized as cost of goods sold during the three months ended March 31, 2024.

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

September 30, 2024

March 31, 2025

December 31, 2024

Contract assets

Deferred revenues from associated contracts

Net contract assets

Insurance proceeds receivable for litigation settlement

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Total prepaid expenses and other current assets

Based on the arrangements under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items, the unbilled contract assets as of September 30, 2024 included $ 24.8 million of unbilled receivables from Falikang and $ 1.0 million of unbilled development revenue under the AstraZeneca China Amendment.

Such amounts are no longer subject to right of offset under the settlement agreements.

The unbilled contract assets as of December 31, 2023 included $ 22.5 million of unbilled co-development revenue under the AstraZeneca China Amendment and the $ 4.0 million unbilled regulatory milestone payment under the AstraZeneca China Agreement, which were netted against the contract liabilities (deferred revenue) in the same contract.

These amounts were billed during the three months ended September 30, 2024 under the above-mentioned settlement agreements.

As of each of September 30, 2024 and December 31, 2023 , the Company recorded a $ 28.5 million receivable in prepaid expenses and other current assets, corresponding to the accrued litigation settlement of the same amount related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit.

As of December 31, 2024 , the Company recorded a $ 28.5 million receivable in prepaid expenses and other current assets, corresponding to the accrued litigation settlement of the same amount related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit.

As the Company maintains insurance that covers exposure related to the class action lawsuit, this amount is fully recoverable under the Company’s insurance policies.

The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers.

Such amount was fully distributed during the three months ended March 31, 2025.

As a result, the related accrued liability and the corresponding receivable were fully settled as of March 31, 2025.

See the Accrued and Other Current Liabilities section below, and the Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies , for details.

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Accrued and other current liabilities consisted of the following (in thousands):

September 30, 2024

March 31, 2025

December 31, 2024

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Accrued restructuring charge

Inventory cost related

Accrued co-promotion expenses - current

Roxadustat profit share to AstraZeneca

Lease termination related

Value added taxes and other taxes

Professional services

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Total accrued and other current liabilities

The accrued liabilities of $ 12.6 million and $ 51.0 million for API and bulk drug product price true-up as of September 30, 2024 and December 31, 2023, respectively, resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and the bulk drug product shipments to AstraZeneca under the terms of the AstraZeneca Master Supply Agreement.

During the second quarter of 2024, the Company paid $ 35.3 million to Astellas and $ 11.5 million to AstraZeneca related to accrued amounts.

The accrued liabilities of $ 13.3 million and $ 13.1 million for API and bulk drug product price true-up as of March 31, 2025 and December 31, 2024, respectively, resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, and the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement.

See the Drug Product Revenue, Net section in Note 3, Collaboration Agreements, License Agreement and Revenues, for details.

As of September 30, 2024 and December 31, 2023 , the accrued litigation settlement of $ 28.5 million was related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit, as mentioned above.

As of December 31, 2024 , the accrued litigation settlement of $ 28.5 million was related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit, which was fully distributed during the three months ended March 31, 2025, as mentioned above.

See the Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies , for details.

Responding to the reported results for pamrevlumab on July 30, 2024, the Company implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously wind down remaining obligations, and reducing U.S.

Responding to the reported results for pamrevlumab in July 2024, the Company implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously wind down remaining obligations, and reducing U.S.

workforce by approximately 75 %.

As a result, the Company recorded a total of $ 18.6 million non-recurring restructuring charge during the three months ended September 30, 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions.

During the three months ended September 30, 2024, total cash payments under the reduction in force was $ 6.1 million.

The remaining accrued restructuring charge was $ 14.2 million as of September 30, 2024 and will be substantially paid out by early 2025.

The Company recorded an accrued inventory related cost of $ 8.5 million as of September 30, 2024, as part of the cost of goods sold resulting from the AstraZeneca Termination and Transition Agreement, discussed under Note 2, Collaboration Agreements, License Agreement and Revenues .

As of September 30, 2024, the Company included $ 42.4 million of historical co-promotion balances due to AstraZeneca b ased on the arrangements under the above-mentioned settlement agreements entered in September 2024 between FibroGen China and AstraZeneca, as such amounts are no longer subject to right of offset.

The total cash payments under the reduction in force was $ 1.6 million during the three months ended March 31, 2025.

The remaining accrued restructuring charge of $ 2.6 million as of March 31, 2025 will be substantially paid out by mid-2025.

Senior Secured Term Loan Facilities

On April 29, 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by Morgan Stanley Tactical Value, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of (i) a $ 75.0 million initial term loan (the “Initial Term Loan”), (ii) a $ 37.5 million delayed draw term loan that will be funded upon the achievement of certain clinical development milestones (“Delayed Draw Term Loan 1”) and, (iii) an uncommitted delayed draw term loan of up to $ 37.5 million to be funded at the Lenders sole discretion, (“Delayed Draw Term Loan 2” and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the “Term Loans”).

In April 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by Morgan Stanley Tactical Value, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of (i) a $ 75.0 million initial term loan (the “Initial Term Loan”), (ii) a $ 37.5 million delayed draw term loan that will be funded upon the achievement of certain clinical development milestones (“Delayed Draw Term Loan 1”) and, (iii) an uncommitted delayed draw term loan of up to $ 37.5 million to be funded at the Lenders sole discretion, (“Delayed Draw Term Loan 2” and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the “Term Loans”).

Pursuant to the Financing Agreement, the Lenders have funded the Initial Term Loan.

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The Company has determined that certain other features embedded within the Loan should be bifurcated and accounted for separately as a derivative.

At inception and as of September 30, 2024, the fair values of such derivatives were negligible due to the low probability of the underlying events.

At inception and as of March 31, 2025, the fair values of such derivatives were negligible due to the low probability of the underlying events.

The Term Loans shall accrue interest at a fixed rate of 14.0 % per annum, payable monthly in arrears.

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The initial issuance costs and the related transaction costs, totaling $ 3.7 million is amortized as interest expense using the effective interest method over the term of the Initial Term Loan and are reported on the balance sheet as a direct deduction from the amount of the Initial Term Loan.

The effective annual interest rate of the Initial Term Loan was 16.13 % for the three and nine months ended September 30, 2024 and 2023 .

The Company recorded interest expense of $ 2.9 million and $ 8.7 million, respectively, for the three and nine months ended September 30, 2024, respectively.

The Company recorded interest expense of $ 2.9 million and $ 4.5 million for the three and nine months ended September 30, 2023, respectively.

As of September 30, 2024 , the related accrued interest was $ 0.4 million.

The Company was in compliance with all debt covenants associated with the senior secured term loan facilities as of September 30, 2024 , including maintaining a minimum balance of $ 30 million of unrestricted cash and cash equivalents held in accounts in the U.S.

The Company’s senior secured term loan facilities as of September 30, 2024 were as follows (in thousands):

September 30, 2024

The effective annual interest rate of the Initial Term Loan was 16.13 % for the three months ended March 31, 2025 and 2024 .

The Company recorded interest expense of $ 3.0 million and $ 2.9 million for the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025 , the related accrued interest was $ 0.4 million.

The Company was in compliance with all debt covenants associated with the senior secured term loan facilities as of March 31, 2025 , including maintaining a minimum balance of $ 30 million of unrestricted cash and cash equivalents held in accounts in the U.S.;

such minimum balance covenant was subsequently amended to be $ 27 million on May 8, 2025 by the Company and the Lenders.

The balances of the Company’s senior secured term loan facilities as of March 31, 2025 and December 31, 2024 were as follows (in thousands):

March 31, 2025

December 31, 2024

Principal of senior secured term loan facilities

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Liability Related to Sale of Future Revenues

On November 4, 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”), pursuant to which the Company granted NovaQuest 22.5 % of its drug product revenue and 10.0 % ( 20.0 % for fiscal year 2028 and thereafter) of its revenue from milestone payments that it is entitled to under the Astellas Agreements , for a consideration of $ 50.0 million (“Investment Amount”) before advisory fees.

In November 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”), pursuant to which the Company granted NovaQuest 22.5 % of its drug product revenue and 10.0 % ( 20.0 % for fiscal year 2028 and thereafter) of its revenue from milestone payments that it is entitled to under the Astellas Agreements , for a consideration of $ 50.0 million (“Investment Amount”) before advisory fees.

In November 2022, the Company received the Investment Amount, net of initial issuance costs, and accounted for it as long-term debt based on the terms of the RIFA because the risks and rewards to NovaQuest are limited by the terms of the transaction.

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On a quarterly basis, the Company reassesses the expected total revenue and the timing of such revenue, recalculates the amortization of debt discount and transactions costs and effective interest rate, and adjusts the accounting prospectively as needed.

The Company’s estimated effective annual interest rate was 15.59 % as of September 30, 2024.

The following table summarizes the activities of the liability related to sale of future revenues for the nine months ended September 30, 2024:

Nine Months Ended

September 30, 2024

The Company’s estimated effective annual interest rate was 15.60 % as of March 31, 2025.

The following table summarizes the activities of the liability related to sale of future revenues for the three months ended March 31, 2025:

Three Months Ended

March 31, 2025

Liability related to sale of future revenues - beginning balance

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Liability related to sale of future revenues, non-current

During the three and nine months ended September 30, 2024, the Company recognized, under Astellas Agreements, development revenue of $ 0.4 million and $ 1.0 million , respectively, and drug product revenue of $( 0.3 ) million and $( 0.7 ) million , respectively.

During the three months ended March 31, 2025 and 2024, the Company recognized, under Astellas Agreements, development revenue of $ 0.1 million and $ 0.3 million , respectively, and drug product revenue of $ 2.6 million and $( 1.2 ) million, respectively.

See Note 3, Collaboration Agreements, License Agreement and Revenue , for details.

During the three and nine months ended September 30, 2024 , the Company recognized the related interest expense of $ 2.0 million and $ 5.8 million, respectively.

During the three and nine months ended September 30, 2023 , the Company recognized the related interest expense of $ 2.1 million and $ 5.6 million, respectively.

During the first quarter of 2024, the Company paid $ 5.7 million accrued interest.

During the three months ended March 31, 2025 and 2024 , the Company recognized the related interest expense of $ 2.2 million and $ 2.0 million, respectively.

During the three months ended March 31, 2025 and 2024 , the Company paid $ 0.5 million and $ 5.7 million accrued interest, respectively.

Based on the current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms discussed above, the Company anticipates reaching a Payment Cap up to $ 125.0 million by 2031.

Provisions for (benefits from) income tax for the three and nine months ended September 30, 2024 and 2023 were primarily due to foreign taxes.

Provisions for income tax for the three months ended March 31, 2025 and 2024 were immaterial and due to foreign taxes.

Based upon the weight of available evidence, which includes its historical operating performance, reported cumulative net losses since inception, the Company has established and continues to maintain a full valuation allowance against its net deferred tax assets as it does not currently believe that realization of those assets is more likely than not.

Related Party Transactions

Astellas is an equity investor in the Company and is considered a related party.

The Company recorded license and development revenue related to collaboration agreements with Astellas of $ 0.4 million and $ 2.4 million for the three months ended September 30, 2024 and 2023, and $ 1.0 million and $ 5.8 million for the nine months ended September 30, 2024 and 2023, respectively.

In addition, the Company recorded drug product revenue from Astellas of $( 0.3 ) million and $ 1.3 million for the three months ended September 30, 2024 and 2023, and $( 0.7 ) million and $ 17.7 million for the nine months ended September 30, 2024 and 2023, respectively.

See Note 2, Collaboration Agreements, License Agreement and Revenues , for details.

The Company’s expense related to collaboration agreements with Astellas was immaterial for each of the three and nine months ended September 30, 2024 and 2023.

As of September 30, 2024 and December 31, 2023 , accounts receivable from Astellas were $ 0.2 million and $ 0.8 million, respectively.

As of September 30, 2024 and December 31, 2023 , total deferred revenue from Astellas was $ 8.1 million and $ 16.9 million, respectively.

As of September 30, 2024, the amounts due to Astellas, included in accrued and other current liabilities, and other long-term liabilities, totaled $ 13.2 million.

As of December 31, 2023 , the amount due to Astellas, included in accrued and other current liabilities, and other long-term liabilities, totaled $ 40.5 million.

Falikang, an entity jointly owned by FibroGen Beijing and AstraZeneca, is an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company.

FibroGen Beijing owns 51.1 % of Falikang’s equity.

See the Equity method investment - Unconsolidated VIE - Falikang section of Note 4, Variable Interest Entities , for details.

The net product revenue from Falikang was $ 42.2 million and $ 26.5 million for the three months ended September 30, 2024 and 2023, and $ 115.3 million and $ 68.3 million for the nine months ended September 30, 2024 and 2023, respectively.

See the Product Revenue, Net section in Note 2, Collaboration Agreements, License Agreement and Revenues , for details.

The investment income in Falikang was $ 0.9 million and $ 0.7 million for the three months ended September 30, 2024 and 2023 and $ 2.7 million and $ 2.0 million for the nine months ended September 30, 2024 and 2023 , respectively.

During the three months ended September 30, 2024, the Company received $ 2.2 million of dividend distribution from Falikang.

As of September 30, 2024 and December 31, 2023, the Company’s equity method investment in Falikang was $ 5.8 million and $ 5.3 million , respectively.

See the Equity method investment - Unconsolidated VIE - Falikang section of Note 4, Variable Interest Entities , for details.

The other income from Falikang was immaterial for each of the three and nine months ended September 30, 2024 and 2023.

As of September 30, 2024 and December 31, 2023 , accounts receivable, net, from Falikang, were $ 15.3 million and $ 5.2 million, respectively.

Commitments and Contingencies

Contract Obligations

As of September 30, 2024 , the Company had outstanding total non-cancelable purchase obligations of $ 1.0 million for manufacture and supply of roxadustat, and $ 6.0 million for other purchases and programs.

As of March 31, 2025 , the Company had outstanding total non-cancelable purchase obligations of $ 2.3 million for general purchases and other programs, $ 0.7 million for manufacture and supply of roxadustat, and $ 0.3 million for Manufacture and supply of FG-3246.

The Company expects to fulfill its commitments under these agreements in the normal course of business, and as such, no liability has been recorded.

Some of the Company’s license agreements provide for periodic maintenance fees over specified time periods, as well as payments by the Company upon the achievement of development, regulatory and commercial milestones.

As of September 30, 2024 , future milestone payments for research and preclinical stage development programs consisted of up to approximately $ 697.9 million in total potential future milestone payments under the Company’s license agreements with HiFiBiO (HK) Ltd.

HiFiBiO Therapeutics) (for Gal-9 and CCR8), and Medarex, Inc.

These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones.

The event triggering such payment or obligation has not yet occurred.

As of September 30, 2024, the Company had $ 2.0 million of operating lease liabilities.

In addition, see Note 7, Senior Secured Term Loan Facilities and Note 8, Liability Related to Sale of Future Revenues for details of the related obligations.

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A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision.

The Company did not have any material accruals for any active legal action, except for the class action settlement mentioned below, in its condensed consolidated balance sheet as of September 30, 2024, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure.

Between April 2021 and May 2021, five putative securities class action complaints were filed against FibroGen and certain of its current and former executive officers (collectively, the “Defendants”) in the U.S.

The Company did not have any material accruals for any active legal action, except for the class action settlement mentioned below, in its condensed consolidated balance sheet as of March 31, 2025, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure.

Between April 2021 and May 2021, five putative securities class action complaints were filed against FibroGen and certain of its former executive officers (collectively, the “Defendants”) in the U.S.

District Court for the Northern District of California.

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On October 17, 2023, the parties reached an agreement in principle to settle the class action at $ 28.5 million.

Accordingly, as of December 31, 2023, the Company recorded the $ 28.5 million in accrued and other current liabilities in the consolidated balance sheet.

Accordingly, as of December 31, 2024, the Company recorded the $ 28.5 million in accrued and other current liabilities in the condensed consolidated balance sheet.

The Company maintains insurance that covers exposure related to the class action lawsuit.

As the amount is fully recoverable under the Company’s insurance policies, the Company recorded a corresponding receivable in prepaid expenses and other current assets in the condensed consolidated balance sheet.

The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers.

The Court preliminarily approved the settlement on February 13, 2024 and approved the settlement Plan of Allocations on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024, reserving further orders on the final judgment until after the claims and distribution process was completed.

The Court preliminarily approved the settlement on February 13, 2024 and approved the settlement Plan of Allocation on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024, reserving further orders on the final judgment until after the claims and distribution process was completed.

The court entered a class distribution order on January 1, 2025 and the amount was fully distributed during the first quarter of 2025.

As a result, the related accrued liability and the corresponding receivable were fully settled as of March 31, 2025.

Another case, filed on May 25, 2023, against the same defendants, asserting similar claims as the class action and additional common-law and California state fraud claims was voluntarily dismissed on December 20, 2023.

Between July 30, 2021 and April 3, 2024, seven shareholder derivative complaints were filed, naming as defendants certain of our current and former officers and certain current and former members of our board, as well as FibroGen as nominal defendants (the “Derivative Lawsuits”).

Of these Derivative Lawsuits, four were filed in the Delaware Court of Chancery (the “Delaware Chancery Derivative Actions”), two were filed in the U.S.

Between July 30, 2021 and April 3, 2024, seven shareholder derivative complaints were filed, naming as defendants certain of the Company’s current and former officers and certain current and former members of the Company’s board, as well as FibroGen as nominal defendants (the “Derivative Lawsuits”).

Of these Derivative Lawsuits, four were filed in the Delaware Court of Chancery, two were filed in the U.S.

District Court for the District of Delaware (the “Delaware Federal Derivative Actions”), and one was filed in the U.S.

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The complaints seek unspecified damages, attorneys’ fees, and other costs.

The status of the seven Derivative Lawsuits is currently as follows:

• Two of the Delaware Chancery Derivative Actions, filed on April 14, 2022, and June 1, 2023, have been consolidated (the “Delaware Chancery Consolidated Derivative”).

On February 1, 2024, Defendants moved to dismiss the Delaware Chancery Consolidated Derivative action, which the Court granted on October 2, 2024.

The Delaware Chancery Consolidated Derivative was dismissed with prejudice on October 30, 2024.

The other two Delaware Chancery Derivative Actions, filed in the Delaware Court of Chancery on December 3, 2023 and April 3, 2024, were consolidated and stayed pending resolution of the motion to dismiss the Delaware Chancery Consolidated Derivative action;

• The Delaware Federal Derivative Actions remain stayed pending resolution of the motion to dismiss the Delaware Chancery Consolidated Derivative action;

• The California Federal Derivative Action was voluntarily dismissed on January 22, 2024.

The Company believes that the claims asserted in the Derivative Lawsuits are without merit and it intends to vigorously defend against them.

However, any litigation is inherently uncertain, and any judgment or injunctive relief entered against FibroGen, or any adverse settlement could materially and adversely impact its business, results of operations, financial condition, and prospects.

All seven Derivative Lawsuits have been dismissed.

In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data.

The SEC followed up with a subpoena for additional documents in the second quarter of 2024.

The Company is fully cooperating with the SEC, and is currently discussing with the SEC for a potential settlement.

The Company cannot predict the outcome.

Any adverse outcome in this matter or any related proceeding could expose the Company to substantial damages, penalties, or reputational harm that may have a material adverse impact on the Company’s business, results of operations, financial condition, growth prospects, and price of its common stock.

Between 2022 and 2024, the Company’s Board of Directors received six litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the pending derivative and securities class action lawsuits.

The Company may in the future receive such additional demands.

In May 2025, the Company entered into a settlement with the SEC, subject to Commission approval.

As part of the settlement, and without admitting or denying the findings in the settlement offer or administrative order to be issued by the SEC, the Company agreed to pay a $ 1.25 million civil penalty.

Between 2022 and 2024, the Company’s Board of Directors received seven litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the pending derivative and securities class action lawsuits.

The Company may in the future receive additional similar demands.

Starting in October 2021, certain challenges have been filed with the China National Intellectual Property Administration against patents which claim a crystalline form of roxadustat.

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The Company believes the estimated fair value of these arrangements is minimal.

Segment Information

The Company has one operating and reporting segment which primarily focuses on the development and commercialization of novel therapeutics to treat serious unmet medical needs.

The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”).

The CODM assesses performance of the business, monitors budget versus actual results and manages and allocates resources to the Company’s operations using consolidated net income (loss) as the primary measurement.

The CODM is regula rly provided with entity-wide expense categories that are consistent with those found on the Company’s condensed consolidated statements of operations.

The measure of segment assets is reported on the balance sheet as total consolidated assets.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements