What changed in this filing

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Item 1. Financial Statements

2025-11-10 compared with 2025-08-11 · 218 added, 202 removed, 463 unchanged (48% of the section changed)

2 unchanged sentences

(In thousands, except per share amounts)

June 30, 2025

September 30, 2025

December 31, 2024

5 unchanged sentences

Total current assets

Long-term investments

Long-term assets held for sale

4 unchanged sentences

Deferred revenue

Senior secured term loan facilities, current

Current liabilities held for sale

13 unchanged sentences

no shares issued

and outstanding at June 30, 2025 and December 31, 2024

and outstanding at September 30, 2025 and December 31, 2024

Common stock, $ 0.01 par value;

225,000 shares authorized at June 30, 2025

225,000 shares authorized at September 30, 2025

and December 31, 2024;

4,045 and 4,037 shares issued and outstanding

at June 30, 2025 and December 31, 2024

at September 30, 2025 and December 31, 2024

Additional paid-in capital

9 unchanged sentences

(In thousands, except per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Development and other revenue

10 unchanged sentences

Interest expense

Loss on debt extinguishments

Interest income and other income (expenses), net

1 unchanged sentence

Loss from continuing operations before income taxes

Benefit from income taxes

Provision for (benefit from) 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 loss per share - basic and diluted

Net income (loss) per share - basic and diluted

Weighted average number of common shares used to calculate

2 unchanged sentences

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE LOSS

CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Net income (loss)

Other comprehensive income (loss):

Foreign currency translation adjustments

Available-for-sale investments:

Unrealized loss on investments, net of tax effect

Cumulative currency translation adjustment attributable to divestiture

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

Other comprehensive income (loss), net of taxes

Comprehensive loss

Comprehensive income (loss)

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

8 unchanged sentences

Non-Controlling

March 31, 2025

Foreign currency

translation adjustments

Shares issued from stock

plans, net of payroll

Redemption of fractional

shares due to reverse

Stock-based compensation

June 30, 2025

Balance at March 31,

Change in unrealized gain

or loss on investments

Foreign currency

translation adjustments

Change in unrealized gain or

loss on investments

Foreign currency translation

Cumulative currency translation

adjustment attributable to

divestiture (Note 2)

Distribution to non-controlling

interest (Note 9)

Shares issued from stock

plans, net of payroll

plans, net of payroll taxes

Stock-based compensation

September 30, 2025

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, 2024

FIBROGEN, INC.

2 unchanged sentences

(In thousands, except share data)

For The Six Month Period

For The Nine Month Period

Comprehensive

7 unchanged sentences

translation adjustments

Cumulative currency translation

adjustment attributable to

divestiture (Note 2)

Distribution to non-controlling

interest (Note 9)

Shares issued from stock

4 unchanged sentences

Stock-based compensation

June 30, 2025

September 30, 2025

December 31, 2023

6 unchanged sentences

Stock-based compensation

Balance at June 30,

September 30, 2024

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

2 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Operating activities

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

Net income (loss)

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

operating activities:

2 unchanged sentences

Investment income in unconsolidated variable interest entity

Gain on divestiture

Loss on debt extinguishments

Impairment of property and equipment

1 unchanged sentence

Stock-based compensation

Dividend received from unconsolidated variable interest entity

Changes in operating assets and liabilities:

13 unchanged sentences

Purchases of property and equipment

Proceeds from divestiture, net of cash transferred

Proceeds from sale of property and equipment

1 unchanged sentence

Proceeds from maturities of investments

Net cash provided by (used in) investing activities

Net cash provided by investing activities

Financing activities

Repayments of senior secured term loan facilities

Payment of senior secured term loan facilities pay-off premium and fees

Repayments of finance lease liabilities

Cash paid for payroll taxes on restricted stock unit releases

Cash paid to non-controlling interest

Payment of issuance cost under ATM Program

14 unchanged sentences

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, pending close of the sale of FibroGen International to AstraZeneca Treasury Limited.

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 (“FibroGen Beijing”) 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 (“SAMR”).

The Company initiated 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 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 August 29, 2025, the Company closed the sale of its China operations through FibroGen International (Hong Kong) Ltd.

(“FibroGen International”) to AstraZeneca Treasury Limited pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended (“Share Purchase Agreement”) for a total consideration of $ 220.4 million comprised of $ 85.0 million in enterprise value and $ 135.4 million in net cash held in China.

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

For additional details, refer to Note 2, Discontinued Operations and Divestiture.

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:

1 unchanged sentence

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

The Company had a positive Type-C meeting with the U.S.

Food and Drug Administration (“FDA”) in July 2025, and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, including the starting dose and the inclusion criteria.

Basis of Presentation and Principles of Consolidation

8 unchanged sentences

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.

This sale includes all of FibroGen’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1 % interest in Falikang.

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 June 30, 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.

agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited ( the “Transaction”) .

(“Falikang”).

The Transaction was closed on August 29, 2025 for a total consideration of $ 220.4 million, subject to certain customary adjustments as set forth in the purchase agreement, comprised of $ 85.0 million in enterprise value and $ 135.4 million in net cash held in China.

Accordingly, 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 for all periods presented, and therefore, the condensed consolidated statements of operations and the notes to the condensed consolidated financial statements were recasted for all comparative periods presented to classify FibroGen International as discontinued operations.

In addition, the related assets and liabilities were classified within the condensed consolidated balance sheets as held for sale for each balance sheet date before the Transaction closes since December 31, 2024.

See Note 2, Discontinued Operations and Divestiture , for related disclosures.

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

Reverse Stock Split

5 unchanged sentences

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 complete the above mentioned sale of FibroGen International, access additional cash from its China operations, or raise additional capital in the U.S., 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 $ 18.75 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.

at any time through equity, equity-linked, or debt financing arrangements or from other sources.

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

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.

GAAP applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

As disclosed in previous filings (including the September 30, 2024 Form 10-Q and subsequent Form 10-K and Form 10-Qs), if the Company was unable to complete the above-mentioned Transaction, access additional cash from its China operations, or raise additional capital in the U.S., 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 were issued and would not be able to comply with its financial covenant that required a minimum balance 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 with Morgan Stanley Tactical Value (“MSTV”) would become immediately due and payable.

These factors had raised substantial doubt about the Company’s ability to continue as a going concern.

On August 29, 2025, u pon the Transaction close, the Company received cash for the sale of $ 210.4 million and repaid its senior secured term loan facilities with MSTV, outstanding interest and related premium and fees for approximately $ 80.9 million.

With the cash proceeds from the Transaction close, based on its current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund the Company’s planned operating requirements for at least the 12 months following the issuance of the financial statements for September 30, 2025.

Use of Estimates

1 unchanged sentence

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period.

The more significant areas requiring the use of management estimates and assumptions include valuation and recognition of revenue and deferred revenue, specifically, estimates in variable consideration for drug product sales, and estimates in transaction price per unit for the China performance obligation.

On an ongoing basis, management reviews these estimates and assumptions.

5 unchanged sentences

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 loss from continuing operations for each of the three and six months ended June 30, 2025 and 2024.

The Company reported a loss from continuing operations for each of the three and nine months ended September 30, 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 June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Employee stock options

14 unchanged sentences

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

Discontinued Operations

Discontinued Operations and Divestiture

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.

This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing 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 June 30, 2025 and December 31, 2024.

The 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 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 and six months ended June 30, 2025 and 2024 were as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The Transaction was closed on August 29, 2025 for a total consideration of $ 220.4 million comprised of $ 85.0 million in cash for the enterprise value of FibroGen International and $ 135.4 million in net cash held in China.

The total consideration included a $ 210.4 million in cash paid at closing, and a total of $ 10.0 million cash payable by AstraZeneca at the closing subject to holdbacks of:

(i) a $ 6.0 million holdback to offset final net cash adjustments which will be released following a customary adjustment process approximately 90 days post-closing (as such time may be extended for the parties to mutually agree upon final adjustments), and (ii) a $ 4.0 million holdback to satisfy any indemnity claims, which will be released, net of any claims paid or unresolved, nine months after the closing.

The Company does not expect such adjustments to be material, therefore have recorded the $ 10.0 million as other receivable as of September 30, 2025, which were included in the prepaid expenses and other current assets on the condensed consolidated balance sheets.

On November 6, 2025, the Company received a $ 6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $ 6.0 million, plus $ 0.4 million that was an additional payment following the final net cash adjustments after closing.

The financial results of the discontinued operations with respect to FibroGen International reflected in the condensed consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024 were as follows (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Product revenue, net

7 unchanged sentences

Interest expense

Gain on divestiture

Interest income and other income (expenses), net

5 unchanged sentences

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 June 30, 2025 and December 31, 2024 were as follows (in thousands):

June 30, 2025

The gain on divestiture of $ 52.2 million was resulted from the above-mentioned total consideration of $ 220.4 million, less the transaction costs and fees of $ 7.8 million, and the derecognition of the net equity of $ 154.9 million of FibroGen International at the Transaction close and the cumulative currency translation adjustments of $ 5.5 million.

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 December 31, 2024 were as follows (in thousands):

December 31, 2024

13 unchanged sentences

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 six months ended June 30, 2025 and 2024 were as follows (in thousands):

Six Months Ended June 30,

Investment loss (income) in unconsolidated variable interest entity

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 nine months ended September 30, 2025 and 2024 were as follows (in thousands):

Nine Months Ended September 30,

Investment income in unconsolidated variable interest entity

Gain on divestiture

Impairment of property and equipment

Dividend received from unconsolidated variable interest entity

Stock-based compensation

1 unchanged sentence

FibroGen Beijing owns 51.1 % of Falikang’s equity.

The net product revenue from sales to Falikang were $ 16.4 million and $ 46.0 million for the three months ended June 30, 2025 and 2024, and $ 53.3 million and $ 73.1 million for the six months ended June 30, 2025 and 2024, respectively.

The product revenue recognized for the three months ended June 30, 2025 included a decrease in revenue of $ 12.1 million resulting from changes to estimated variable consideration in the current period relating to performance obligation satisfied in previous periods.

The other income from Falikang were immaterial for the three and six months ended June 30, 2025 and 2024.

The investment income in Falikang was $ 1.7 million and $ 1.2 million for the three months ended June 30, 2025 and 2024 , and $ 1.1 million and $ 1.8 million for the six months ended June 30, 2025 and 2024 , respectively.

As of June 30, 2025 and December 31, 2024, the Company’s equity method investment in Falikang were $ 8.1 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 June 30, 2025 and December 31, 2024, accounts receivable, net, from Falikang were $ 19.1 million and $ 13.9 million, respectively, which were included in the current assets held for sale on the condensed consolidated balance sheets.

The net product revenue from sales to Falikang were $ 165.3 million and $ 42.2 million for the three months ended September 30, 2025 and 2024, and $ 218.6 million and $ 115.3 million for the nine months ended September 30, 2025 and 2024, respectively.

The product revenue recognized for the three months ended September 30, 2025 included an increase in revenue of $ 118.3 million resulting from changes to estimated variable consideration in the current period relating to performance obligation satisfied in previous periods.

The other income from Falikang were immaterial for the three and nine months ended September 30, 2025 and 2024.

The investment income in Falikang was $ 1.4 million and $ 0.9 million for the three months ended September 30, 2025 and 2024 , and $ 2.5 million and $ 2.7 million for the nine months ended September 30, 2025 and 2024 , respectively.

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

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

Collaboration Agreements, License Agreement and Revenues

4 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 under the Astellas Japan Agreement through June 30, 2025 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 September 30, 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 no t material for the three and six months ended June 30, 2025 and 2024.

The transaction price related to consideration received through June 30, 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.

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 June 30, 2025 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 and nine months ended September 30, 2025 and 2024.

The transaction price related to consideration received through September 30, 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 June 30, 2025 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 September 30, 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 no t material for the three and six months ended June 30, 2025 and 2024.

The transaction price related to consideration received through June 30, 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 $ 288.4 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 June 30, 2025 under the Astellas Europe Agreement.

Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were no t material for the three and nine months ended September 30, 2025 and 2024.

The transaction price related to consideration received through September 30, 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 $ 288.5 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, 2025 under the Astellas Europe Agreement.

3 unchanged sentences

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

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”).

On February 23, 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement, effective as of February 25, 2024 (“AstraZeneca Termination and Transition Agreement”).

In July 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 Agreement and Astellas Japan Agreement (“AstraZeneca U.S./RoW Agreement”).

On February 25, 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement, as amended and restated on August 29, 2025 (“AstraZeneca Termination and Transition Agreement”).

Pursuant to the AstraZeneca Termination and Transition Agreement, AstraZeneca returns all of their non-China roxadustat rights to the Company, with the exception of South Korea, and provides certain assistance during a transition period.

4 unchanged sentences

Accordingly, during the first quarter of 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.

AstraZeneca China Agreement

Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (“AstraZeneca China Agreement”).

AstraZeneca was the Company’s long-time commercialization partner for roxadustat in greater China.

In July 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (“AstraZeneca China Agreement”).

Under the terms of the AstraZeneca China Agreement, AstraZeneca agreed to pay upfront consideration and potential milestone payments, totaling $ 376.7 million .

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 June 30, 2025 totaled $ 81.2 million .

The aggregate amount of such consideration received for milestone and upfront payments through September 30, 2025 totaled $ 81.2 million .

As discussed in Note 2, Discontinued Operations and Divestiture, on August 29, 2025, the Transaction was completed to sell the Company’s China operations to AstraZeneca pursuant to the Share Purchase Agreement.

AstraZeneca China Amendment

4 unchanged sentences

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 $ 16.4 million and $ 46.0 million for the three months ended June 30, 2025 and 2024, and $ 53.3 million and $ 73.1 million for the six months ended June 30, 2025 and 2024, respectively, which 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 first quarter of 2024, the Company recorded the final development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which was immaterial.

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 $ 551.1 million for China performance obligation (with cumulative revenue of $ 408.1 million through June 30, 2025) that is recognized as product revenue, net included in discontinued operations as described under China Performance Obligation section below.

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 $ 573.4 million for China performance obligation (with cumulative revenue of $ 573.4 million through September 30, 2025) that is recognized as product revenue, net, included in discontinued operations as described under China Performance Obligation section below.

China Performance Obligation

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Periodically, the Company updates its assumptions such as total sales quantity, timing of China’s volume-based purchasing program, performance period, gross transaction price, profit share and other inputs including foreign currency translation impact, among others.

The China Health Authority has accepted abbreviated new drug applications for over 20 generics roxadustat applicants and approved multiple for marketing in China, since roxadustat’s inclusion in the 2023 National Reimbursement Drug List.

In July 2025, roxadustat was announced as being included in the 11 th round of the China’s volume-based purchasing program whereby a national tender has been called.

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.

While the related product revenue recognized is included in discontinued operations, as of June 30, 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 of FibroGen International.

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

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

As discussed in Note 2, Discontinued Operations and Divestiture, the divestiture of FibroGen International was completed on August 29, 2025 and accordingly, the performance obligation to AstraZeneca was completely satisfied upon the closing of the divestiture.

As a result, all the previously deferred revenues were recognized as revenue during the three months ended September 30, 2025.

The following table includes a roll-forward of the related deferred revenue that was considered as a contract liability that was not included in the disposal group held for sale as of December 31, 2024 (in thousands):

December 31, 2024

(Discontinued

June 30, 2025

September 30, 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.

As of June 30, 2025 , approximately $ 20.7 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.

The related net product revenue recognized from the sales to Falikang was $ 165.3 million and $ 42.2 million for the three months ended September 30, 2025 and 2024, and $ 218.6 million and $ 115.3 million for the nine months ended September 30, 2025 and 2024, respectively, which were included in the discontinued operations in the condensed consolidated statements of operations together with the sales directly to distributors.

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 six months ended June 30, 2025 and 2024 (in thousands):

Three Months Ended June 30,

Six Months Ended June 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 and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

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.

The adjustment to the drug product revenue for the three months ended June 30, 2025 was immaterial.

As a result, the Company recorded a reduction to the drug product revenue of $ 0.4 million f or the three months ended September 30, 2025.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect foreign exchange impacts, among others.

For the three months ended June 30, 2025, the adjustment to the drug product revenue was immaterial.

For the three months ended March 31, 2025, 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 $ 1.8 million.

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 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.

For the three months ended September 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 $ 1.4 million.

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.

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.

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.

As of June 30, 2025, t he balances related to the API price true-up under the Astellas Japan Agreement were $ 0.6 million in accrued liabilities, representing the Company’s best estimate of the timing for these amounts to be paid.

As of September 30, 2025, t he balances related to the API price true-up under the Astellas Japan Agreement were $ 1.0 million in accrued 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.

Further for the six months ended June 30, 2025, the Company reclassified $ 1.3 million from the related deferred revenue to accrued liabilities.

As of June 30, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $ 11.9 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 $ 1.2 million and $ 1.1 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement for the three months ended June 30, 2025 and 2024 , and $ 2.0 million and $ 2.1 million for the six months ended June 30, 2025 and 2024, respectively.

Further for the nine months ended September 30, 2025, the Company reclassified $ 0.9 million from the related deferred revenue to accrued liabilities.

As of September 30, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $ 11.4 million in a ccrued liabilities, representing the Company’s best estimate that these amounts will be paid within the next 12 months, a $ 7.1 million of which was paid to Astellas in October 2025.

The Company recognized royalty revenue of $ 1.3 million and $ 1.1 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement for the three months ended September 30, 2025 and 2024 , and $ 3.3 million and $ 3.2 million for the nine months ended September 30, 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

June 30, 2025

September 30, 2025

Drug product revenue - deferred revenue:

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Corresponding to the drug product revenue, during the first quarter of 2024, the Company recorded the related cost of goods sold of $ 21.1 million.

Eluminex Agreement

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.

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.

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 .

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

There was no material revenue recognized under the agreements with Eluminex for the three and six months ended June 30, 2025 and 2024 .

Consolidated Variable Interest Entity - Fortis

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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 June 30, 2025.

Therefore, the Company consolidated Fortis starting from the Option Acquisition Date and continues to consolidate as of September 30, 2025.

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

As of the Option Acquisition Date and June 30, 2025 , 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 September 30, 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 June 30, 2025, total assets and liabilities of Fortis were immaterial.

For the three and six months ended June 30, 2025 and 2024 , Fortis’ net income (losses) was immaterial.

As of September 30, 2025, total assets and liabilities of Fortis were immaterial.

For the three and nine months ended September 30, 2025 and 2024 , 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):

June 30, 2025

September 30, 2025

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.

During the three and six months ended June 30, 2025 , a total of $ 1.3 million and $ 7.8 million, respectively, of U.S.

During the three and nine months ended September 30, 2025 , a total of $ 10.0 million and $ 17.8 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):

June 30, 2025

September 30, 2025

December 31, 2024

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Total cash and cash equivalents

As of September 30, 2025, the Company’s investments consist primarily of available-for-sale debt investments.

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 table below (in thousands):

September 30, 2025

Amortized Cost

Gross Unrealized

Holding Gains

Gross Unrealized

Holding Losses

Corporate bonds

Total investments

As of September 30, 2025 , the available-for-sale investments had remaining contractual maturities of two years .

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.

There was no available for sale security in an unrealized loss position as of September 30, 2025, and the Company did not recognize any other-than-temporary impairment loss during the three and nine months ended September 30, 2025 and 2024.

The Company did not have any short-term or long-term investments as of December 31, 2024.

Prepaid Expenses and Other Current Assets

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

June 30, 2025

September 30, 2025

December 31, 2024

Insurance proceeds receivable for litigation settlement

Holdback consideration receivable related to divestiture

Prepaid assets

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Total prepaid expenses and other current assets

As of September 30, 2025, the Company recorded a $ 10.0 million receivable in prepaid expenses and other current assets for the holdbacks related to the closing of the divestiture of FibroGen International.

See Note 2, Discontinued Operations and Divestiture, for details.

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.

6 unchanged sentences

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

June 30, 2025

September 30, 2025

December 31, 2024

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Total accrued and other current liabilities

The accrued liabilities of $ 12.4 million and $ 13.1 million for API and bulk drug product price true-up as of June 30, 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.

The accrued liabilities of $ 12.4 million and $ 13.1 million for API and bulk drug product price true-up as of September 30, 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.

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workforce by approximately 75 %.

The total cash payments under the reduction in force was $ 0.8 million and $ 2.4 million during the three and six months ended June 30, 2025, respectively.

The remaining accrued restructuring charge of $ 1.7 million as of June 30, 2025 will be substantially paid out in the second half of 2025.

The total cash payments under the reduction in force was $ 0.9 million and $ 3.2 million during the three and nine months ended September 30, 2025, respectively.

The remaining accrued restructuring charge of $ 0.8 million as of September 30, 2025 will be substantially paid out by the end of 2025.

Senior Secured Term Loan Facilities

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.

The clinical development milestones which could have triggered Delayed Draw Term Loan 1 were not achieved, and the Lenders have not funded Delayed Draw Term Loan 2.

As such, these features expired during 2023.

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 June 30, 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.

The Term Loans shall mature on May 8, 2026 .

Therefore, the balance of the Term Loans was included in senior secured term loan facilities, current, under the current liabilities on the condensed consolidated balance sheet as of June 30, 2025.

The Term Loans will not be subject to amortization payments.

The Company is permitted to prepay the Term Loans from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Term Loans being repaid or prepaid, plus accrued and unpaid interest of the portion of the Term Loans being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Term Loans being repaid or prepaid as if such Term Loans were to remain outstanding until the scheduled maturity date.

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 six months ended June 30, 2025 and 2024 .

The Company recorded interest expense of $ 3.0 million and $ 5.9 million for the three and six months ended June 30, 2025, and $ 2.9 million and $ 5.8 million for the three and six months ended June 30, 2024, respectively, which were included in discontinued operations as the Company is required to repay the loan upon the closing of the divestiture of FibroGen International.

As of June 30, 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 June 30, 2025 , including maintaining a minimum balance of $ 22.5 million of unrestricted cash and cash equivalents held in accounts in the U.S.;

such minimum balance covenant was subsequently amended to be $ 18.75 million on July 14, 2025 by the Company and the Lenders.

The balances of the Company’s senior secured term loan facilities as of June 30, 2025 and December 31, 2024 were as follows (in thousands):

June 30, 2025

In April 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by MSTV, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities, and received $ 74.1 million, representing a $ 75.0 million i nitial term loan (the “Initial Term Loan”), net of $ 0.9 million issuance costs.

The Initial Term Loan accrued interest at a fixed rate of 14.0 % per annum, payable monthly in arrears.

The Initial Term Loan would mature on May 8, 2026 .

The Initial Term Loan was subject to amortization payments.

The Company was permitted to prepay the Initial Term Loan from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Initial Term Loan being repaid or prepaid, plus accrued and unpaid interest of the portion of the Initial Term Loan being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Initial Term Loan being repaid or prepaid as if such Initial Term Loan were to remain outstanding until the scheduled maturity date.

The initial issuance costs and the related transaction costs, totaling $ 3.7 million were amortized as interest expense using the effective interest method over the term of the Initial Term Loan and were 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, 2025 and 2024 .

The Company recorded interest expense of $ 1.9 million and $ 7.8 million for the three and nine months ended September 30, 2025 , and $ 2.9 million and $ 8.7 million, respectively, for the three and nine months ended September 30, 2024, respectively, which were included in discontinued operations as the Company was required to repay the loan upon the closing of the divestiture of FibroGen International.

On August 29, 2025, u pon the above-mentioned Transaction close, the Company paid the Lenders a total of $ 80.9 million, including $ 75.0 million for paying off the senior secured term loan facilities, $ 0.4 million for outstanding interest and $ 5.5 million for related premium and fees.

Accordingly, the Company recorded a loss on debt extinguishments of $ 6.6 million, including the $ 5.5 million of premium and fees and a $ 1.1 million amortization of issuance costs, for the three and nine months ended September 30, 2025.

The balance of the Company’s senior secured term loan facilities as of December 31, 2024 was as follows (in thousands):

December 31, 2024

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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 15.43 % as of June 30, 2025.

The following table summarizes the activities of the liability related to sale of future revenues for the six months ended June 30, 2025:

Six Months Ended

June 30, 2025

The Company’s estimated effective annual interest rate was 15.23 % as of September 30, 2025.

The following table summarizes the activities of the liability related to sale of future revenues for the nine months ended September 30, 2025:

Nine Months Ended

September 30, 2025

Liability related to sale of future revenues - beginning balance

4 unchanged sentences

Liability related to sale of future revenues, non-current

During the three and six months ended June 30, 2025, the Company recognized, under Astellas Agreements, development revenue of $ 0.1 million and $ 0.3 million , respectively, and drug product revenue of $ 1.2 million and $ 3.8 million , respectively.

During the three and six months ended June 30, 2024 , the Company recognized, under Astellas Agreements, development revenue of $ 0.3 million and $ 0.6 million, respectively, and drug product revenue of $ 0.7 million and $( 0.5 ) million, respectively.

During the three and nine months ended September 30, 2025, the Company recognized, under Astellas Agreements, development revenue of $ 0.1 million and $ 0.4 million , respectively, and drug product revenue of $ 1.0 million and $ 4.8 million , respectively.

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.

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

During the three and six months ended June 30, 2025 , the Company recognized the related interest expense of $ 2.0 million and $ 4.1 million, respectively.

During the three and six months ended June 30, 2024 , the Company recognized the related interest expense of $ 1.7 million and $ 3.7 million, respectively.

During six months ended June 30, 2025 and 2024 , the Company paid $ 0.5 million and $ 5.7 million accrued interest, respectively.

During the three and nine months ended September 30, 2025 , the Company recognized the related interest expense of $ 2.0 million and $ 6.1 million, respectively.

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 nine months ended September 30, 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 income tax for the three and six months ended June 30, 2025 and 2024 were immaterial and due to foreign taxes.

FibroGen Cayman Non-Controlling Interests

FibroGen International (Cayman) Limited (“FibroGen Cayman”) has 15,836,966 Series A Preference Shares outstanding, including 10,484,260 shares owned by FibroGen Inc.

and 5,352,706 shares owned by minority shareholders, and 78,000,000 common shares outstanding owned by FibroGen Inc.

In the event of liquidation, dissolution, or winding up of the entity, either voluntary or involuntary, including by means of a merger, the holders of FibroGen Cayman Series A Preference Shares are entitled to be paid an amount equal to their liquidation preference as set forth in the FibroGen Cayman Amended and Restated Memorandum and Articles of Association (the “Articles”).

The discontinued operations sold under the Transaction discussed in the above Note 2, Discontinued Operations and Divestiture , consisted substantially all the assets owned by FibroGen Cayman, and therefore triggered liquidation distribution process of FibroGen Cayman based on its Articles.

Accordingly, during the three months ended September 30, 2025, the Company distributed a total of $ 5.4 million to FibroGen Cayman’s minority shareholders ($ 1.00 for each of the FibroGen Cayman Series A Preference Shares held by the minority shareholders) , and correspondingly recorded a reduction to the related nonredeemable non-controlling interests of $ 7.5 million and an adjustment to additional paid-in capital of $ 2.1 million, for such distribution.

Any further distribution, if applicable, will be paid out on a pro-rata basis to the holders of all common and Series A Preference shares of FibroGen Cayman, and is subject to future adjustments, if any, including additional proceeds received from the holdbacks related to the Transaction, and future costs of FibroGen Cayman.

Provisions for (benefits from) income tax for the three and nine months ended September 30, 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.

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which contains a broad range of tax reform provisions affecting businesses.

The Company is still in the process of evaluating the legislation and an estimate of the financial impact cannot be made at this time.

The legislation does not have a material impact on the Company’s financial statements.

Commitments and Contingencies

Contract Obligations

As of June 30, 2025 , the Company had outstanding total non-cancelable purchase obligations of $ 3.1 million for general purchases and other programs and $ 0.5 million for manufacture and supply of roxadustat.

As of September 30, 2025 , the Company had outstanding total non-cancelable purchase obligations of $ 4.0 million for general purchases and other programs and $ 2.6 million for manufacture and supply of roxadustat.

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

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.

In addition, see Note 8, Liability Related to Sale of Future Revenues for details of the related obligations.

Legal Proceedings and Other Matters

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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 June 30, 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.

The Company did not have any material accruals for any active legal action, in its condensed consolidated balance sheet as of September 30, 2025.

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

District Court for the Northern District of California.

The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for U.S.

Food and Drug Administration approval.

On August 30, 2021, the Court consolidated the actions and appointed a group of lead plaintiffs.

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

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 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 approved the settlement Plan of Allocation on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024.

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 in the same period.

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 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.

District Court for the Northern District of California (the “California Federal Derivative Action”).

The plaintiffs assert state and federal claims based on some of the same alleged misstatements as the securities class action complaint.

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

All seven Derivative Lawsuits have been dismissed.

The settlement was fully covered by insurance.

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.

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

In May 2025, the Company entered into a settlement with the SEC.

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.

Final resolution of such proceedings will take time and the Company could not predict the ultimate outcome, or reasonably estimate the potential exposure.

In September 2025, the agreement was approved by the Commission.

The litigation demands have been withdrawn.

Indemnification Agreements

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The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable.

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

Segment Information

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

These significant segment expense include cost of goods sold, research and development expenses, selling, general and administrative expenses, and restructuring charge.

Other segment items that are presented on the condensed consolidated statements of operations include interest and other income (expense), net, and provision for (benefit from) income taxes.

These significant segment expenses include cost of goods sold, research and development expenses, selling, general and administrative expenses, and restructuring charge.

Other segment items that are presented on the condensed consolidated statements of operations include interest expense, loss on debt extinguishments, interest income and other income (expense), net, and provision for (benefit from) income taxes.

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