Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDA TED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
September 30, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
117,975
$
50,482
Accounts receivable, net
121
481
Inventories
3,864
3,155
Prepaid expenses and other current assets
11,463
31,542
Current assets held for sale
—
110,849
Total current assets
133,423
196,509
Long-term investments
3,035
—
Other assets
556
1,405
Long-term assets held for sale
—
16,611
Total assets
$
137,014
$
214,525
Liabilities, redeemable non-controlling interests and deficit
Current liabilities:
Accounts payable
$
5,093
$
5,064
Accrued and other current liabilities
25,776
62,035
Deferred revenue
5,104
27,290
Current liabilities held for sale
—
38,917
Total current liabilities
35,973
133,306
Product development obligations
19,471
17,012
Deferred revenue, net of current
573
114,708
Senior secured term loan facilities, non-current
—
73,092
Liability related to sale of future revenues, non-current
63,414
58,864
Other long-term liabilities
98
822
Long-term liabilities held for sale
—
356
Total liabilities
119,529
398,160
Commitments and Contingencies (Note 11)
Redeemable non-controlling interests
21,480
21,480
Stockholders’ deficit:
Preferred stock, $ 0.01 par value; 125,000 shares authorized; no shares issued
and outstanding at September 30, 2025 and December 31, 2024
—
—
Common stock, $ 0.01 par value; 225,000 shares authorized at September 30, 2025
and December 31, 2024; 4,045 and 4,037 shares issued and outstanding
at September 30, 2025 and December 31, 2024
1,011
1,009
Additional paid-in capital
1,675,999
1,668,620
Accumulated other comprehensive loss
( 2,211
)
( 5,732
)
Accumulated deficit
( 1,691,827
)
( 1,889,499
)
Total stockholders’ deficit attributable to FibroGen
( 17,028
)
( 225,602
)
Nonredeemable non-controlling interests
13,033
20,487
Total deficit
( 3,995
)
( 205,115
)
Total liabilities, redeemable non-controlling interests and deficit
$
137,014
$
214,525
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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FIBROGEN, INC.
CONDENSED CONSOLIDATED S TATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Revenue:
Development and other revenue
$
119
$
385
396
1,532
Drug product revenue, net
957
( 262
)
4,767
24,954
Total revenue
1,076
123
5,163
26,486
Operating costs and expenses:
Cost of goods sold
( 58
)
( 75
)
278
21,407
Research and development
1,209
19,974
16,249
88,824
Selling, general and administrative
5,295
9,362
20,459
40,984
Restructuring charge
41
18,554
560
18,554
Total operating costs and expenses
6,487
47,815
37,546
169,769
Loss from operations
( 5,411
)
( 47,692
)
( 32,383
)
( 143,283
)
Interest and other, net
Interest expense
( 2,083
)
( 2,069
)
( 6,346
)
( 6,029
)
Loss on debt extinguishments
( 6,583
)
—
( 6,583
)
—
Interest income and other income (expenses), net
931
1,472
1,628
4,608
Total interest and other, net
( 7,735
)
( 597
)
( 11,301
)
( 1,421
)
Loss from continuing operations before income taxes
( 13,146
)
( 48,289
)
( 43,684
)
( 144,704
)
Provision for (benefit from) income taxes
—
3
( 90
)
( 271
)
Loss from continuing operations
( 13,146
)
( 48,292
)
( 43,594
)
( 144,433
)
Income from discontinued operations, net of tax
213,782
31,208
241,266
78,872
Net income (loss)
$
200,636
$
( 17,084
)
$
197,672
$
( 65,561
)
Loss from continuing operations per share - basic and diluted
$
( 3.25
)
$
( 12.01
)
$
( 10.79
)
$
( 36.19
)
Income from discontinued operations per share - basic and diluted
52.86
7.76
59.69
19.76
Net income (loss) per share - basic and diluted
$
49.61
$
( 4.25
)
$
48.90
$
( 16.43
)
Weighted average number of common shares used to calculate
net income (loss) per share - basic and diluted
4,044
4,021
4,042
3,991
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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FIBROGEN, INC.
CONDENSED CONSOLIDATED STATE MENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Net income (loss)
$
200,636
$
( 17,084
)
$
197,672
$
( 65,561
)
Other comprehensive income (loss):
Foreign currency translation adjustments
( 2,898
)
( 1,821
)
( 1,959
)
1,271
Cumulative currency translation adjustment attributable to divestiture
5,479
—
5,479
—
Unrealized gain (loss) on investments, net of tax effect
2
2
1
( 24
)
Other comprehensive income (loss), net of taxes
2,583
( 1,819
)
3,521
1,247
Comprehensive income (loss)
203,219
( 18,903
)
201,193
( 64,314
)
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENT S OF CHANGES IN REDEEMABLE NON-CONTROLLING
INTERESTS AND STOCKHOLDERS’ DEFICIT
(In thousands, except share data)
(Unaudited)
For The Three Month Period
Common Stock
Additional
Paid-in
Accumulated
Other
Comprehensive
Accumulated
Nonredeemable
Non-Controlling
Total
Redeemable
Non-Controlling
Shares
Amount
Capital
Loss
Deficit
Interests
Deficit
Interests
(Note 1)
Balance at
June 30, 2025
4,043,899
$
1,011
$
1,673,249
$
( 4,794
)
$
( 1,892,463
)
$
20,487
$
( 202,510
)
$
21,480
Net income
—
—
—
—
200,636
—
200,636
—
Change in unrealized gain or
loss on investments
—
—
—
2
—
—
2
—
Foreign currency translation
adjustments
—
—
—
( 2,898
)
—
—
( 2,898
)
—
Cumulative currency translation
adjustment attributable to
divestiture (Note 2)
—
—
—
5,479
—
—
5,479
—
Distribution to non-controlling
interest (Note 9)
—
—
2,101
—
—
( 7,454
)
( 5,353
)
—
Shares issued from stock
plans, net of payroll taxes
paid
1,546
—
( 13
)
—
—
—
( 13
)
—
Stock-based compensation
—
—
662
—
—
—
662
—
Balance at
September 30, 2025
4,045,445
$
1,011
$
1,675,999
$
( 2,211
)
$
( 1,691,827
)
$
13,033
$
( 3,995
)
$
21,480
Balance at June 30,
2024
4,015,990
$
1,004
$
1,660,862
$
( 3,809
)
$
( 1,890,397
)
$
20,487
$
( 211,853
)
$
21,480
Net loss
—
—
—
—
( 17,084
)
—
( 17,084
)
—
Change in unrealized gain or
loss on investments
—
—
—
2
—
—
2
—
Foreign currency translation
adjustments
—
—
—
( 1,821
)
—
—
( 1,821
)
—
Shares issued from stock
plans, net of payroll taxes
paid
14,814
4
( 115
)
—
—
—
( 111
)
—
Stock-based compensation
—
—
7,687
—
—
—
7,687
—
Balance at
September 30, 2024
4,030,804
$
1,008
$
1,668,434
$
( 5,628
)
$
( 1,907,481
)
$
20,487
$
( 223,180
)
$
21,480
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FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE NON-CONTROLLING
INTERESTS AND STOCKHOLDERS’ DEFICIT (CONTINUED)
(In thousands, except share data)
(Unaudited)
For The Nine Month Period
Common Stock
Additional
Paid-in
Accumulated
Other
Comprehensive
Accumulated
Nonredeemable
Non-Controlling
Total
Redeemable
Non-Controlling
Shares
Amount
Capital
Loss
Deficit
Interests
Deficit
Interests
(Note 1)
Balance at
December 31, 2024
4,036,678
$
1,009
$
1,668,620
$
( 5,732
)
$
( 1,889,499
)
$
20,487
$
( 205,115
)
$
21,480
Net income
—
—
—
—
197,672
—
197,672
—
Change in unrealized gain
or loss on investments
—
—
—
1
—
—
1
—
Foreign currency
translation adjustments
—
—
—
( 1,959
)
—
—
( 1,959
)
—
Cumulative currency translation
adjustment attributable to
divestiture (Note 2)
—
—
—
5,479
—
—
5,479
—
Distribution to non-controlling
interest (Note 9)
—
—
2,101
—
—
( 7,454
)
( 5,353
)
—
Shares issued from stock
plans, net of payroll
taxes paid
8,822
2
( 63
)
—
—
—
( 61
)
—
Issuance cost under
ATM Program
—
—
( 46
)
—
—
—
( 46
)
—
Redemption of fractional
shares due to reverse
stock split
( 55
)
—
—
—
—
—
—
—
Stock-based compensation
—
—
5,387
—
—
—
5,387
—
Balance at
September 30, 2025
4,045,445
$
1,011
$
1,675,999
$
( 2,211
)
$
( 1,691,827
)
$
13,033
$
( 3,995
)
$
21,480
Balance at
December 31, 2023
3,950,809
$
988
$
1,643,641
$
( 6,875
)
$
( 1,841,920
)
$
20,487
$
( 183,679
)
$
21,480
Net loss
—
—
—
—
( 65,561
)
—
( 65,561
)
—
Change in unrealized gain
or loss on investments
—
—
—
( 24
)
—
—
( 24
)
—
Foreign currency
translation adjustments
—
—
—
1,271
—
—
1,271
—
Shares issued from stock
plans, net of payroll
taxes paid
79,995
20
( 244
)
—
—
—
( 224
)
—
Stock-based compensation
—
—
25,037
—
—
—
25,037
—
Balance at
September 30, 2024
4,030,804
$
1,008
$
1,668,434
$
( 5,628
)
$
( 1,907,481
)
$
20,487
$
( 223,180
)
$
21,480
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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FIBROGEN, INC.
CONDENSED CONSOLIDATED S TATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Nine Months Ended September 30,
2025
2024
Operating activities
Net income (loss)
$
197,672
$
( 65,561
)
Adjustments to reconcile net income (loss) to net cash provided by (used in)
operating activities:
Depreciation
713
2,312
Amortization of finance lease right-of-use assets
27
28
Net accretion of premium and discount on investments
1
( 1,680
)
Investment income in unconsolidated variable interest entity
( 2,485
)
( 2,664
)
Gain on divestiture
( 52,163
)
—
Loss on debt extinguishments
6,583
—
Impairment of property and equipment
2,062
—
Loss on disposal of property and equipment
—
2,445
Stock-based compensation
5,387
25,037
Dividend received from unconsolidated variable interest entity
3,947
2,230
Changes in operating assets and liabilities:
Accounts receivable, net
( 2,449
)
( 15,958
)
Inventories
5,240
17,778
Prepaid expenses and other current assets
54,774
( 18,181
)
Operating lease right-of-use assets
808
66,011
Other assets
( 1,072
)
1,115
Accounts payable
( 26,306
)
( 8,705
)
Accrued and other liabilities
( 48,148
)
( 17,112
)
Operating lease liabilities, current
( 568
)
( 12,796
)
Deferred revenues
( 136,321
)
( 15,218
)
Accrued interest expense related to sale of future revenues
5,659
115
Accrued interest for finance lease liabilities
( 19
)
18
Operating lease liabilities, non-current
( 202
)
( 65,830
)
Other long-term liabilities
414
( 917
)
Net cash provided by (used in) operating activities
13,554
( 107,533
)
Investing activities
Purchases of property and equipment
( 38
)
( 125
)
Proceeds from divestiture, net of cash transferred
90,204
—
Proceeds from sale of property and equipment
—
840
Purchases of available-for-sale securities
( 3,035
)
( 8,628
)
Proceeds from maturities of investments
—
132,183
Net cash provided by investing activities
87,131
124,270
Financing activities
Repayments of senior secured term loan facilities
( 75,000
)
—
Payment of senior secured term loan facilities pay-off premium and fees
( 5,550
)
—
Repayments of finance lease liabilities
( 4
)
( 36
)
Cash paid for payroll taxes on restricted stock unit releases
( 61
)
( 340
)
Cash paid to non-controlling interest
( 5,353
)
—
Payment of issuance cost under ATM Program
( 46
)
—
Proceeds from issuance of common stock under employee stock plans
—
116
Net cash used in financing activities
( 86,014
)
( 260
)
Effect of exchange rate change on cash and cash equivalents
1,126
838
Net increase in cash and cash equivalents
15,797
17,315
Total cash and cash equivalents at beginning of period
102,178
113,688
Total cash and cash equivalents at end of period
$
117,975
$
131,003
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
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FIBROGEN, INC.
NOTES TO THE CONDENSED CONSOL IDATED FINANCIAL STATEMENTS
(Unaudited)
1. Significant Accounting Policies
Description of Operations
FibroGen, Inc. (“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
The Company is developing FG-3246, a potential first-in-class antibody-drug conjugate (“ADC”) targeting CD46, for the treatment of metastatic castration-resistant prostate cancer (“mCRPC”) and potentially other cancers. This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent. The Company 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”). Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements: one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
The Company continues to 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
The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U.S. Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 17, 2025.
The condensed consolidated financial statements include the accounts of FibroGen, its wholly-owned subsidiaries and its majority-owned subsidiaries, as well as any variable interest entity (“VIE”) for which FibroGen is the primary beneficiary. All inter-company transactions and balances have been eliminated in consolidation.
The Company operates as one reportable segment — the development and commercialization of novel therapeutics to treat serious unmet medical needs.
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Discontinued Operations
On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited ( the “Transaction”) . 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 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.
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 since December 31, 2024. 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. 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
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
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.
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.
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Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. 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, which was completed during the third quarter of 2025 upon the above-mentioned Transaction close. On an ongoing basis, management reviews these estimates and assumptions. Changes in facts and circumstances may alter such estimates and actual results could differ from those estimates. In the Company’s opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair statement of its financial position, results of operations and cash flows for the interim periods presented.
Significant Accounting Policies
The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 17, 2025.
Net Income (Loss) per Share
Potential common shares that would have the effect of increasing diluted earnings per share are considered to be anti-dilutive and as such, these shares are not included in the calculation of diluted earnings per share. The Company reported a 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 September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Employee stock options
459
611
486
572
RSUs, PRSUs and TSR awards
27
136
38
147
ESPP
—
19
—
19
486
766
524
738
Risks and Uncertainties
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, the liquidity and capital resources of the Company, intellectual property protection for the Company’s proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties.
Recently Issued Accounting Guidance Not Yet Adopted
In November 2024, the FASB issued Accounting Standards Update (“ASU”) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), and relevantly in January 2025, the FASB issued ASU 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The guidance requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses. This guidance is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. This guidance should be applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements. The Company is currently in the process of evaluating the effects of this guidance on its related disclosures.
10
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In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. This guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
2. 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. 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 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,
2025
2024
2025
2024
Revenue:
Product revenue, net
$
167,179
46,210
$
226,651
$
126,391
Operating costs and expenses:
Cost of goods sold
3,761
5,371
13,454
14,820
Research and development
438
1,733
1,739
5,382
Selling, general and administrative
1,311
8,191
14,849
21,666
Total operating costs and expenses
5,510
15,295
30,042
41,868
Income from operations
161,669
30,915
196,609
84,523
Interest and other, net
Interest expense
( 1,900
)
( 2,926
)
( 7,816
)
( 8,745
)
Gain on divestiture
52,163
—
52,163
—
Interest income and other income (expenses), net
475
2,330
( 2,173
)
484
Total interest and other, net
50,738
( 596
)
42,174
( 8,261
)
Income before income taxes
212,407
30,319
238,783
76,262
Provision for income taxes
—
9
—
54
Investment income in unconsolidated variable interest entity
1,375
898
2,483
2,664
Income from discontinued operations, net of tax
$
213,782
$
31,208
$
241,266
$
78,872
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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 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
Assets
Cash and cash equivalents
$
51,696
Accounts receivable, net
18,443
Inventories
15,547
Prepaid expenses and other current assets
25,163
Total current assets held for sale
110,849
Property and equipment, net
7,041
Equity method investment in unconsolidated variable interest entity
6,864
Operating lease right-of-use assets
1,716
Other assets
990
Total long-term assets held for sale
16,611
Liabilities
Accounts payable
$
26,974
Accrued and other current liabilities
10,679
Operating lease liabilities, current
1,264
Total current liabilities held for sale
38,917
Operating lease liabilities, non-current
356
Total long-term liabilities held for sale
356
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,
2025
2024
Depreciation
$
713
$
1,117
Investment income in unconsolidated variable interest entity
( 2,485
)
( 2,664
)
Gain on divestiture
( 52,163
)
—
Impairment of property and equipment
2,062
—
Dividend received from unconsolidated variable interest entity
3,947
2,230
Stock-based compensation
$
231
$
1,326
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Included in the discontinued operations, Falikang, an entity jointly owned by FibroGen Beijing and AstraZeneca is an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company. FibroGen Beijing owns 51.1 % of Falikang’s equity.
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.
3. Collaboration Agreements, License Agreement and Revenues
Astellas Agreements
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 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 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.
There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended September 30, 2025 under the Astellas Japan Agreement. 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.
In 2018, FibroGen and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”). The related drug product revenue is described under the Drug Product Revenue, Net section below.
Astellas Europe Agreement
In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Astellas Europe Agreement”). Under the terms of the Astellas Europe Agreement, Astellas agreed to pay license fees, other upfront consideration and various milestone payments, totaling $ 745.0 million . U nder the Astellas Europe Agreement, Astellas committed to fund 50 % of joint development costs for Europe and North America, and all territory-specific costs. The Astellas Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range .
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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 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. 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 Europe Agreement.
In 2021, the Company entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement (“Astellas EU Supply Agreement”) to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies. The related drug product revenue is described under the Drug Product Revenue, Net section below.
AstraZeneca Agreements
AstraZeneca U.S./Rest of World (“RoW”) 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. In addition, as a part of this AstraZeneca Termination and Transition Agreement, AstraZeneca will receive tiered mid-single digit royalties on FibroGen’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue FibroGen receives if it licenses or sells such rights to a third-party. Neither party incurred any early termination penalties.
The aggregate amount of consideration for milestone and upfront payments received under the AstraZeneca U.S./RoW Agreement through the termination totaled $ 439.0 million , excluding drug product revenue under the Master Supply Agreement with AstraZeneca under the AstraZeneca U.S./RoW Agreement (“AstraZeneca Master Supply Agreement”), entered in 2020, which is described under the Drug Product Revenue, Net section below. 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 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.
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 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.
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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.
Substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in limited areas in China. FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transfer price, which is adjusted for the estimated profit share. Further discussion related to the sales to Falikang is discussed under the China Performance Obligation section below.
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 $ 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
Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang. Substantially all direct roxadustat product sales to distributors in China are made by Falikang. FibroGen Beijing manufactures and supplies commercial product to Falikang. The net transaction price for FibroGen Beijing’s product sales to Falikang is based on a gross transaction price, adjusted for the estimated profit share.
The roxadustat sales to Falikang marked the beginning of the Company’s China performance obligation under the Company’s agreements with AstraZeneca . Product revenue is based on the transaction price of the China performance obligation. Revenue is recognized when control of the product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period. 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. 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):
Balance at
December 31, 2024
Additions
Recognized
as Revenue
(Discontinued
Operations)
Currency
Translation
and Other
Balance at
September 30, 2025
AstraZeneca China performance obligation
- deferred revenue
$
( 132,097
)
$
( 82,494
)
$
218,575
$
( 3,984
)
$
—
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.
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Drug Product Revenue, Net
Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2025
2024
2025
2024
Astellas Japan Agreement
$
( 378
)
$
( 1,355
)
$
1,446
$
( 3,926
)
Astellas Europe Agreement
1,335
1,093
3,321
3,209
AstraZeneca U.S./RoW Agreement
—
—
—
25,671
Drug product revenue, net
$
957
$
( 262
)
$
4,767
$
24,954
Astellas Japan Agreement
The Company updates its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment at each balance sheet date. As a result, the Company recorded a reduction to the drug product revenue of $ 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 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.
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 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.
Astellas Europe Agreement
The Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement in the prior years. The Company recognized the related fully burdened manufacturing costs as drug product revenue in the respective periods and recorded the constrained transaction price in deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. The Company updates its estimate of variable consideration related to the bulk drug product transferred in prior years at each balance sheet date.
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During the fourth quarter of 2024, the Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $ 0.6 million as drug product revenue, and recorded $ 4.4 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. In addition, the Company updated its estimate of variable consideration related to the bulk drug product transferred in prior years. Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items. As a result, for the year ended December 31, 2024, the Company reclassified $ 7.2 million from the related deferred revenue to accrued liabilities. As of December 31, 2024, the related balance in accrued liabilities was $ 10.5 million. 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.
The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands):
Balance at
December 31, 2024
Recognized as Revenue
Reclassified to Accrued Liability / Accounts Payable
Balance at
September 30, 2025
Drug product revenue - deferred revenue:
Astellas Europe Agreement
$
( 9,901
)
$
3,321
$
903
$
( 5,677
)
AstraZeneca U.S./RoW Agreement
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 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.
4. 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 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. If FibroGen exercises the option to acquire Fortis, it will pay Fortis an option exercise payment of $ 80.0 million, and thereafter, legacy Fortis shareholders would be eligible to receive from FibroGen up to $ 200.0 million in contingent payments associated with the achievement of various regulatory approvals. If FibroGen acquires Fortis, it would also be responsible to pay University of California, San Francisco (“UCSF”), an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the licensing arrangement between Fortis and UCSF . If FibroGen chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.
On March 28, 2025, the Company and Fortis entered into amendments and modified the option exercise deadline to December 31, 2027.
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Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement (together the “Fortis Agreements”), FibroGen has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by FibroGen, and manufacturing of FG-3246 during the up-to four-year option period (which ends on the earlier of 120 days after Fortis or FibroGen submits data from any Phase 2 clinical trial of a product to the U.S. Food and Drug Administration for the purpose of progressing to a Phase 3 clinical trial or December 31, 2027 absent extension). As part of the clinical development strategy, FibroGen will continue the work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection. Additionally, the Company is obligated to make four quarterly payments totaling $ 5.4 million to Fortis in support of its continued development obligations, of which the last payment was $ 1.7 million and made during the three months ended March 31, 2024.
Pursuant to the guidance under ASC 810, Consolidation (“ASC 810”), the Company determined that Fortis is a VIE and that the Company is the primary beneficiary of Fortis, as through the Fortis Agreements the Company has the power to direct activities that most significantly impact the economic performance of Fortis. Therefore, the Company consolidated Fortis starting from the Option Acquisition Date and continues to consolidate as of September 30, 2025.
Fortis has authorized and issued common shares and Series A preferred shares. 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. The NCI attributable to the approximately 98 % of Series A preferred shares owned by other investors are classified as redeemable NCI in temporary equity, as the preferred shares are redeemable by the non-controlling shareholders upon occurrence of certain events out of the Company’s control.
Subsequent to the Option Acquisition Date, Fortis’ net income is allocated to its common shares and preferred shares based on their respective stated rights. Fortis’ net loss is allocated to its common shares only as the holders of preferred shares do not have a contractual obligation to absorb such losses.
As of September 30, 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.
5. Fair Value Measurements
The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):
September 30, 2025
Level 1
Level 2
Level 3
Total
Money market funds
$
34,207
$
—
$
—
$
34,207
Corporate bonds
—
3,035
—
3,035
Commercial paper
—
59,578
—
59,578
U.S. government bonds
12,460
9,976
—
22,436
Total
$
46,667
$
72,589
$
—
$
119,256
December 31, 2024
Level 1
Level 2
Level 3
Total
Money market funds
$
28,241
$
—
$
—
$
28,241
Commercial paper
—
14,269
—
14,269
U.S. government bonds
2,987
2,981
—
5,968
Total
$
31,228
$
17,250
$
—
$
48,478
The Company’s Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. 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 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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6. Balance Sheet Components
Cash and Cash Equivalents
Cash and cash equivalents consisted of the following (in thousands):
September 30, 2025
December 31, 2024
Cash
$
1,754
$
2,004
Commercial paper
59,578
14,269
Money market funds
34,207
28,241
U.S. government bonds
22,436
5,968
Total cash and cash equivalents
$
117,975
$
50,482
Investments
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
Estimated
Fair Value
Corporate bonds
$
3,034
$
1
$
—
$
3,035
Total investments
$
3,034
$
1
$
—
$
3,035
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):
September 30, 2025
December 31, 2024
Insurance proceeds receivable for litigation settlement
$
—
$
28,500
Holdback consideration receivable related to divestiture
10,000
—
Prepaid assets
768
1,903
Other current assets
695
1,139
Total prepaid expenses and other current assets
$
11,463
$
31,542
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.
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As of December 31, 2024 , the Company recorded a $ 28.5 million receivable in prepaid expenses and other current assets, corresponding to the accrued litigation settlement of the same amount related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit. As the Company maintains insurance that covers exposure related to the class action lawsuit, this amount is fully recoverable under the Company’s insurance policies. The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers. Such amount was fully distributed during the 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 11, Commitments and Contingencies , for details.
Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
September 30, 2025
December 31, 2024
Preclinical and clinical trial accruals
$
3,312
$
6,327
API and bulk drug product price true-up
12,398
13,071
Litigation settlement
—
28,500
Payroll and related accruals
3,060
4,640
Accrued restructuring charge
802
4,572
Professional services
2,527
2,049
Current portion of liability related to sale of future revenues
1,569
460
Other
2,108
2,416
Total accrued and other current liabilities
$
25,776
$
62,035
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.
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 first quarter of 2025 as mentioned above. See the Legal Proceedings and Other Matters section in Note 11, Commitments and Contingencies , for details.
Responding to the reported results for pamrevlumab in July 2024, the Company implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously wind down remaining obligations, and reducing U.S. workforce by approximately 75 %. 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.
7. Senior Secured Term Loan Facilities
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.
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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
Principal of senior secured term loan facilities
$
75,000
Less: Unamortized issuance costs and transaction costs
( 1,908
)
Senior secured term loan facilities, ending balance
$
73,092
Representing:
Senior secured term loan facilities, current
$
—
Senior secured term loan facilities, non-current
$
73,092
8. Liability Related to Sale of Future Revenues
In November 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”), pursuant to which the Company granted NovaQuest 22.5 % of its drug product revenue and 10.0 % ( 20.0 % for fiscal year 2028 and thereafter) of its revenue from milestone payments that it is entitled to under the Astellas Agreements , for a consideration of $ 50.0 million (“Investment Amount”) before advisory fees.
In November 2022, the Company received the Investment Amount, net of initial issuance costs, and accounted for it as long-term debt based on the terms of the RIFA because the risks and rewards to NovaQuest are limited by the terms of the transaction. The related debt discount and transaction costs are amortized as interest expense based on the projected balance of the liability as of the beginning of each period. As payments are made to NovaQuest, the balance of the liability related to sale of future revenues is being effectively repaid over the life of the RIFA. The payments to NovaQuest are accounted for as a reduction of debt.
The Company may prepay its obligations to NovaQuest in full at any time during the term of RIFA. The prepayment amount varies from $ 80.0 million to $ 125.0 million less any revenue interest payments made up to such prepayment date. Under the RIFA the Company shall pay to NovaQuest up to a specified maximum amount (“Payment Cap”) of (a) $ 100.0 million, if the payment is made on or before December 31, 2028; (b) $ 112.5 million, if the payment is made on or after January 1, 2029, but on or before December 31, 2029; or (c) $ 125.0 million, if the payment is made after January 1, 2030.
After January 1, 2028, if the product (as defined) is not commercialized for a consecutive twelve-month period, then, the payments owed under the RIFA by the Company to NovaQuest for each fiscal year shall be the greater of: (i) the amount which would otherwise be due pursuant to revenue interest payments terms; or (ii) $ 10.0 million.
Before December 31, 2028, if the sum of all payments under the RIFA paid to NovaQuest, does not equal or exceed $ 62.5 million, then the Company shall pay NovaQuest the difference of these two amounts by no later than March 1, 2029. If, by no later than December 31, 2030, the sum of all payments under the RIFA paid to NovaQuest does not equal or exceed $ 125.0 million, then the Company shall pay NovaQuest the difference of these two amounts by no later than March 1, 2031.
NovaQuest will retain this entitlement until it has reached the Payment Cap, at which point 100 % of such revenue interest on future global net sales of Astellas will revert to the Company.
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Over the course of the RIFA, the effective interest rate is affected by the amount and timing of drug product revenue and revenue from milestone payments recognized, the changes in the timing of forecasted drug product revenue and revenue from milestone payments, and the timing of the Company’s payments to NovaQuest. 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 15.23 % 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
$
59,324
Interest paid
( 450
)
Interest expense recognized
6,109
Liability related to sale of future revenues - ending balance
64,983
Less: Current portion classified to accrued and other current liabilities
( 1,569
)
Liability related to sale of future revenues, non-current
$
63,414
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 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.
9. 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.
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10. Income Taxes
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.
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 legislation does not have a material impact on the Company’s financial statements.
11. Commitments and Contingencies
Contract Obligations
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 8, Liability Related to Sale of Future Revenues for details of the related obligations.
Legal Proceedings and Other Matters
From time to time, the Company is a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value) to adequately address any liabilities related to legal proceedings and other loss contingencies. 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, 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. On October 17, 2023, the parties reached an agreement in principle to settle the class action at $ 28.5 million. 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. 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. 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. In September 2025, the agreement was approved by the Commission.
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 derivative and securities class action lawsuits. The litigation demands have been withdrawn.
Indemnification Agreements
The Company enters into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, including in connection with intellectual property infringement claims by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the extent permissible under applicable law. The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable.
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12. Segment Information
The Company has one operating and reporting segment which primarily focuses on the development and commercialization of novel therapeutics to treat serious unmet medical needs. The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”). The CODM assesses performance of the business, monitors budget versus actual results and manages and allocates resources to the Company’s operations using consolidated net income (loss) as the primary measurement. The CODM is 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 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.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.