What changed in this filing

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Item 1. Financial Statements

2025-08-11 compared with 2025-05-12 · 179 added, 123 removed, 486 unchanged (38% of the section changed)

2 unchanged sentences

(In thousands, except per share amounts)

March 31, 2025

June 30, 2025

December 31, 2024

11 unchanged sentences

Deferred revenue

Senior secured term loan facilities, current

Current liabilities held for sale

13 unchanged sentences

no shares issued

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

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

Common stock, $ 0.01 par value;

225,000 shares authorized at March 31, 2025

225,000 shares authorized at June 30, 2025

and December 31, 2024;

4,044 and 4,037 shares issued and outstanding

at March 31, 2025 and December 31, 2024

at June 30, 2025 and December 31, 2024

Additional paid-in capital

9 unchanged sentences

(In thousands, except per share amounts)

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Development and other revenue

13 unchanged sentences

Loss from continuing operations before income taxes

Provision for income taxes

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 income (loss) per share - basic and diluted

Net 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 INCOME (LOSS)

CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE LOSS

(In thousands)

Three Months Ended March 31,

Net income (loss)

Three Months Ended June 30,

Six Months Ended June 30,

Other comprehensive income (loss):

2 unchanged sentences

Unrealized loss on investments, net of tax effect

Other comprehensive gain, net of taxes

Comprehensive income (loss)

Other comprehensive income (loss), net of taxes

Comprehensive loss

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

8 unchanged sentences

Non-Controlling

Income (Loss)

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

Shares issued from stock

plans, net of payroll

Stock-based compensation

Balance at June 30,

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE NON-CONTROLLING

INTERESTS AND STOCKHOLDERS’ DEFICIT (CONTINUED)

(In thousands, except share data)

For The Six Month Period

Comprehensive

Nonredeemable

Non-Controlling

December 31, 2024

Change in unrealized

gain or loss on

Change in unrealized gain

or loss on investments

Foreign currency

translation adjustments

Shares issued from stock

1 unchanged sentence

Issuance cost under

March 31, 2025

Redemption of fractional

shares due to reverse

Stock-based compensation

June 30, 2025

December 31, 2023

Change in unrealized

gain or loss on

Change in unrealized gain

or loss on investments

Foreign currency

translation adjustments

Shares issued from stock

plans, net of payroll

Balance at March 31,

Stock-based compensation

Balance at June 30,

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

2 unchanged sentences

(In thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Operating activities

Net income (loss)

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

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

operating activities:

1 unchanged sentence

Net accretion of premium and discount on investments

Investment loss (income) in unconsolidated variable interest entity

Investment income in unconsolidated variable interest entity

Impairment of property and equipment

Loss on disposal of property and equipment

Stock-based compensation

14 unchanged sentences

Purchases of property and equipment

Proceeds from sale of property and equipment

Purchases of available-for-sale securities

5 unchanged sentences

Payment of issuance cost under ATM Program

Proceeds from issuance of common stock under employee stock plans

Net cash used in financing activities

Effect of exchange rate change on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Net increase in cash and cash equivalents

Total cash and cash equivalents at beginning of period

9 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.

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.

3 unchanged sentences

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.

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”).

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.

3 unchanged sentences

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.

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.

Basis of Presentation and Principles of Consolidation

9 unchanged sentences

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 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.

2 unchanged sentences

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

Reverse Stock Split

On June 16, 2025, the Company effected a 1-for-25 reverse stock split (the “Reverse Stock Split”).

The Reverse Stock Split reduced the number of issued and outstanding shares of common stock from approximately 101.1 million shares to approximately 4.0 million shares.

Proportionate adjustments have been made to the number of shares available for issuance under the Company’s equity incentive plans as well as outstanding equity awards, in accordance with their respective terms.

All share amounts have been retroactively adjusted in the condensed consolidated financial statements and the notes to the condensed consolidated financial statements, where applicable, to reflect the Reverse Stock Split.

Liquidity and Going Concern

1 unchanged sentence

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 United States, the Company would not have sufficient liquidity to continue operations in the U.S.

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.

16 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 months ended March 31, 2025 and 2024.

The Company reported a loss from continuing operations for each of the three and six months ended June 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 March 31,

Three Months Ended June 30,

Six Months Ended June 30,

Employee stock options

17 unchanged sentences

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.

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 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,

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,

Product revenue, net

11 unchanged sentences

Provision for income taxes

Investment income (loss) in unconsolidated variable interest entity

Investment income 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

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

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 three months ended March 31, 2025 and 2024 were as follows (in thousands):

Three Months Ended March 31,

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

Impairment of property and equipment

Stock-based compensation

1 unchanged sentence

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.

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.

Collaboration Agreements, License Agreement and Revenues

1 unchanged sentence

Astellas Japan Agreement

In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc.

(“Astellas”) for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Astellas Japan Agreement”).

In June 2005, the Company entered into a collaboration agreement with Astellas for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Astellas Japan Agreement”).

Under this agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 172.6 million .

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 March 31, 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 June 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 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.

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 March 31, 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 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.

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 March 31, 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 June 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 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.

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.

11 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 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 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.

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 March 31, 2025 totaled $ 81.2 million .

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

AstraZeneca China Amendment

In July 2020, FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd.

(“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”).

In July 2020, FibroGen China Anemia Holdings, Ltd., FibroGen Beijing, FibroGen International, 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, Falikang, which performs roxadustat distribution, as well as conducts sales and marketing through AstraZeneca.

2 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 $ 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 .

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 three months ended March 31, 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 $ 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.

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.

China Performance Obligation

6 unchanged sentences

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.

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.

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 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.

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):

1 unchanged sentence

(Discontinued

March 31, 2025

June 30, 2025

AstraZeneca China performance obligation

1 unchanged sentence

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 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.

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.

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 months ended March 31, 2025 and 2024 (in thousands):

Three Months Ended March 31,

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,

Astellas Japan Agreement

4 unchanged sentences

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

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

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, and foreign exchange impacts, among others.

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 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 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.

8 unchanged sentences

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

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.

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.

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

March 31, 2025

June 30, 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 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.

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 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 first quarter of 2024, the Company recorded the related cost of goods sold of $ 21.1 million.

Eluminex Agreement

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

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 .

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

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.

(“Fortis”) with its novel Phase 1 ADC, 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 mCRPC with potential applicability in other solid tumors and hematologic malignancies.

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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 March 31, 2025.

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

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

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.

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.

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

2 unchanged sentences

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 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.

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.

Fair Value Measurements

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

March 31, 2025

June 30, 2025

Money market funds

8 unchanged sentences

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

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

2 unchanged sentences

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

March 31, 2025

June 30, 2025

December 31, 2024

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

March 31, 2025

June 30, 2025

December 31, 2024

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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.

Such 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.

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.

1 unchanged sentence

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

March 31, 2025

June 30, 2025

December 31, 2024

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Total accrued and other current liabilities

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.

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.

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

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.

1 unchanged sentence

workforce by approximately 75 %.

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.

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.

Senior Secured Term Loan Facilities

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

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.

1 unchanged sentence

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 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

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

December 31, 2024

2 unchanged sentences

Senior secured term loan facilities, ending balance

Current Portion classified to accrued and other current liabilities

Representing:

Senior secured term loan facilities, current

Senior secured term loan facilities, non-current

18 unchanged sentences

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 15.60 % 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

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

Liability related to sale of future revenues - beginning balance

4 unchanged sentences

Liability related to sale of future revenues, non-current

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.

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.

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

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.

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.

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 months ended March 31, 2025 and 2024 were immaterial and due to foreign taxes.

Provisions for income tax for the three and six months ended June 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.

On July 4, 2025, the One Big Beautiful Bill Act was signed into law in the U.S.

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.

Commitments and Contingencies

Contract Obligations

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.

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.

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

4 unchanged sentences

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 March 31, 2025, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure.

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.

4 unchanged sentences

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 in the condensed consolidated balance sheet.

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 in the condensed consolidated balance sheet as of December 31, 2024.

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.

1 unchanged sentence

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.

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.

25 unchanged sentences

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 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.

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