Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDA TED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
June 30, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
23,367
$
50,482
Accounts receivable, net
136
481
Inventories
3,863
3,155
Prepaid expenses and other current assets
2,306
31,542
Current assets held for sale
132,650
110,849
Total current assets
162,322
196,509
Other assets
839
1,405
Long-term assets held for sale
14,894
16,611
Total assets
$
178,055
$
214,525
Liabilities, redeemable non-controlling interests and deficit
Current liabilities:
Accounts payable
$
10,477
$
5,064
Accrued and other current liabilities
35,916
62,035
Deferred revenue
27,311
27,290
Senior secured term loan facilities, current
73,733
—
Current liabilities held for sale
8,458
38,917
Total current liabilities
155,895
133,306
Product development obligations
19,398
17,012
Deferred revenue, net of current
122,224
114,708
Senior secured term loan facilities, non-current
—
73,092
Liability related to sale of future revenues, non-current
61,306
58,864
Other long-term liabilities
106
822
Long-term liabilities held for sale
156
356
Total liabilities
359,085
398,160
Commitments and Contingencies (Note 10)
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 June 30, 2025 and December 31, 2024
—
—
Common stock, $ 0.01 par value; 225,000 shares authorized at June 30, 2025
and December 31, 2024; 4,044 and 4,037 shares issued and outstanding
at June 30, 2025 and December 31, 2024
1,011
1,009
Additional paid-in capital
1,673,249
1,668,620
Accumulated other comprehensive loss
( 4,794
)
( 5,732
)
Accumulated deficit
( 1,892,463
)
( 1,889,499
)
Total stockholders’ deficit attributable to FibroGen
( 222,997
)
( 225,602
)
Nonredeemable non-controlling interests
20,487
20,487
Total deficit
( 202,510
)
( 205,115
)
Total liabilities, redeemable non-controlling interests and deficit
$
178,055
$
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 June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Revenue:
Development and other revenue
$
133
$
269
277
1,147
Drug product revenue, net
1,215
729
3,811
25,216
Total revenue
1,348
998
4,088
26,363
Operating costs and expenses:
Cost of goods sold
85
140
337
21,483
Research and development
5,865
32,360
15,040
68,848
Selling, general and administrative
7,057
14,906
15,164
31,622
Restructuring charge
393
—
519
—
Total operating costs and expenses
13,400
47,406
31,060
121,953
Loss from operations
( 12,052
)
( 46,408
)
( 26,972
)
( 95,590
)
Interest and other, net
Interest expense
( 2,009
)
( 1,868
)
( 4,265
)
( 3,960
)
Interest income and other income (expenses), net
286
900
698
3,135
Total interest and other, net
( 1,723
)
( 968
)
( 3,567
)
( 825
)
Loss from continuing operations before income taxes
( 13,775
)
( 47,376
)
( 30,539
)
( 96,415
)
Benefit from income taxes
( 92
)
( 281
)
( 90
)
( 274
)
Loss from continuing operations
( 13,683
)
( 47,095
)
( 30,449
)
( 96,141
)
Income from discontinued operations, net of tax
6,080
31,551
27,485
47,664
Net loss
$
( 7,603
)
$
( 15,544
)
$
( 2,964
)
$
( 48,477
)
Loss from continuing operations per share - basic and diluted
$
( 3.38
)
$
( 11.79
)
$
( 7.54
)
$
( 24.18
)
Income from discontinued operations per share - basic and diluted
1.50
7.90
6.81
11.99
Net loss per share - basic and diluted
$
( 1.88
)
$
( 3.89
)
$
( 0.73
)
$
( 12.19
)
Weighted average number of common shares used to calculate
net income (loss) per share - basic and diluted
4,042
3,993
4,040
3,976
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 LOSS
(In thousands)
(Unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Net loss
$
( 7,603
)
$
( 15,544
)
$
( 2,964
)
$
( 48,477
)
Other comprehensive income (loss):
Foreign currency translation adjustments
( 360
)
2,700
939
3,092
Available-for-sale investments:
Unrealized loss on investments, net of tax effect
—
( 2
)
( 1
)
( 26
)
Other comprehensive income (loss), net of taxes
( 360
)
2,698
938
3,066
Comprehensive loss
( 7,963
)
( 12,846
)
( 2,026
)
( 45,411
)
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
March 31, 2025
4,041,758
$
1,010
$
1,671,388
$
( 4,434
)
$
( 1,884,860
)
$
20,487
$
( 196,409
)
$
21,480
Net loss
—
—
—
—
( 7,603
)
—
( 7,603
)
—
Foreign currency
translation adjustments
—
—
—
( 360
)
—
—
( 360
)
—
Shares issued from stock
plans, net of payroll
taxes paid
2,196
1
( 12
)
—
—
—
( 11
)
—
Redemption of fractional
shares due to reverse
stock split
( 55
)
—
—
—
—
—
—
—
Stock-based compensation
—
—
1,873
—
—
—
1,873
—
Balance at
June 30, 2025
4,043,899
$
1,011
$
1,673,249
$
( 4,794
)
$
( 1,892,463
)
$
20,487
$
( 202,510
)
$
21,480
Balance at March 31,
2024
3,978,975
$
995
$
1,652,243
$
( 6,507
)
$
( 1,874,853
)
$
20,487
$
( 207,635
)
$
21,480
Net loss
—
—
—
—
( 15,544
)
—
( 15,544
)
—
Change in unrealized gain
or loss on investments
—
—
—
( 2
)
—
—
( 2
)
—
Foreign currency
translation adjustments
—
—
—
2,700
—
—
2,700
—
Shares issued from stock
plans, net of payroll
taxes paid
37,015
9
31
—
—
—
40
—
Stock-based compensation
—
—
8,588
—
—
—
8,588
—
Balance at June 30,
2024
4,015,990
$
1,004
$
1,660,862
$
( 3,809
)
$
( 1,890,397
)
$
20,487
$
( 211,853
)
$
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 Six 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 loss
—
—
—
—
( 2,964
)
—
( 2,964
)
—
Change in unrealized gain
or loss on investments
—
—
—
( 1
)
—
—
( 1
)
—
Foreign currency
translation adjustments
—
—
—
939
—
—
939
—
Shares issued from stock
plans, net of payroll
taxes paid
7,276
2
( 50
)
—
—
—
( 48
)
—
Issuance cost under
ATM Program
—
—
( 46
)
—
—
—
( 46
)
—
Redemption of fractional
shares due to reverse
stock split
( 55
)
—
—
—
—
—
—
—
Stock-based compensation
—
—
4,725
—
—
—
4,725
—
Balance at
June 30, 2025
4,043,899
$
1,011
$
1,673,249
$
( 4,794
)
$
( 1,892,463
)
$
20,487
$
( 202,510
)
$
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
—
—
—
—
( 48,477
)
—
( 48,477
)
—
Change in unrealized gain
or loss on investments
—
—
—
( 26
)
—
—
( 26
)
—
Foreign currency
translation adjustments
—
—
—
3,092
—
—
3,092
—
Shares issued from stock
plans, net of payroll
taxes paid
65,181
16
( 129
)
—
—
—
( 113
)
—
Stock-based compensation
—
—
17,350
—
—
—
17,350
—
Balance at June 30,
2024
4,015,990
$
1,004
$
1,660,862
$
( 3,809
)
$
( 1,890,397
)
$
20,487
$
( 211,853
)
$
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)
Six Months Ended June 30,
2025
2024
Operating activities
Net loss
$
( 2,964
)
$
( 48,477
)
Adjustments to reconcile net loss to net cash provided by (used in)
operating activities:
Depreciation
530
1,582
Amortization of finance lease right-of-use assets
18
19
Net accretion of premium and discount on investments
( 1
)
( 1,681
)
Investment income in unconsolidated variable interest entity
( 1,108
)
( 1,766
)
Impairment of property and equipment
2,062
—
Loss on disposal of property and equipment
—
306
Stock-based compensation
4,725
17,350
Changes in operating assets and liabilities:
Accounts receivable, net
( 3,001
)
5,962
Inventories
4,210
15,578
Prepaid expenses and other current assets
51,479
4,527
Operating lease right-of-use assets
620
6,806
Other assets
549
441
Accounts payable
( 21,692
)
( 7,977
)
Accrued and other liabilities
( 30,700
)
( 52,663
)
Operating lease liabilities, current
( 434
)
1,489
Deferred revenues
7,537
( 29,501
)
Accrued interest expense related to sale of future revenues
3,684
( 1,904
)
Accrued interest for finance lease liabilities
( 11
)
12
Operating lease liabilities, non-current
( 205
)
( 8,128
)
Other long-term liabilities
103
( 1,132
)
Net cash provided by (used in) operating activities
15,401
( 99,157
)
Investing activities
Purchases of property and equipment
( 29
)
( 43
)
Proceeds from sale of property and equipment
—
3
Purchases of available-for-sale securities
—
( 8,628
)
Proceeds from maturities of investments
—
132,183
Net cash provided by (used in) investing activities
( 29
)
123,515
Financing activities
Repayments of finance lease liabilities
( 2
)
( 20
)
Cash paid for payroll taxes on restricted stock unit releases
( 49
)
( 229
)
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
( 97
)
( 133
)
Effect of exchange rate change on cash and cash equivalents
2,388
2,801
Net increase in cash and cash equivalents
17,663
27,026
Total cash and cash equivalents at beginning of period
102,178
113,688
Total cash and cash equivalents at end of period
$
119,841
$
140,714
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 anticipates initiation of a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory analysis of FG-3180, in the third quarter of 2025, pending close of the sale of FibroGen International to AstraZeneca Treasury Limited.
The Company and its collaboration partners have developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in the People’s Republic of China (“China”), Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.
On February 20, 2025, the Company entered into a share purchase agreement (the “Share Purchase Agreement”) with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd. (“FibroGen International”) to AstraZeneca Treasury Limited. AstraZeneca AB (“AstraZeneca”) is the Company’s long-time commercialization partner for roxadustat in greater China and South Korea. This sale includes all of FibroGen’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd (“FibroGen Beijing”) and its 51.1 % interest in Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”). The transaction is expected to close in the third quarter of 2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation (“SAMR”).
FibroGen has retained the rights to roxadustat in the United States of America (“U.S.”), Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc. (“Astellas”). Roxadustat is not approved for commercialization in any indication in the U.S., Canada, or Mexico. Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements: one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
The Company continues to 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
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 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 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 SAMR. The Company analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in FibroGen’s business and qualified as a discontinued operation. As a result, the Company determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with Financial Accounting Standard Board (“FASB”) Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements , as of June 30, 2025 and December 31, 2024. Accordingly, the condensed consolidated balance sheets and the condensed consolidated statements of operations, and the notes to the condensed consolidated financial statements were recasted for all periods presented to reflect the discontinuation of FibroGen International in accordance with ASC 205. The operating results related to FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations, while the related assets and liabilities were classified within the condensed consolidated balance sheets as held for sale for all periods presented. See Note 2, Discontinued Operations , for related disclosures. Unless otherwise noted, discussion in the notes to these consolidated financial statements, relates to solely to the Company’s continuing operations.
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 and does not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described below.
If the Company is unable to complete the above mentioned sale of FibroGen International, access additional cash from its China operations, or raise additional capital in the U.S., the Company would not have sufficient liquidity to continue operations in the U.S. for the 12 months from the date that the financial statements are issued and would not be able to comply with its financial covenant that requires a minimum balance of $ 18.75 million of unrestricted cash and cash equivalents to be held in accounts in the United States. Upon an event of default, the Company’s senior secured term loan facilities could become immediately due and payable. The Company has evaluated measures to access additional cash from its China operations and believes the sale of FibroGen International represents the most efficient way to access the entirety of its cash from China upon closing of the transaction. There is also the potential that the Company raises additional funds in the U.S. at any time through equity, equity-linked, or debt financing arrangements or from other sources. There can be no assurances that these plans will be successful. As a result of these factors, the Company has determined that there is substantial doubt about its ability to continue as a going concern within 12 months after the date that the financial statements are issued.
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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. 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 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 June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Employee stock options
490
603
500
551
RSUs, PRSUs and TSR awards
36
156
42
157
ESPP
—
18
—
20
526
777
542
728
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.
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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
On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited, pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd. agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited for an aggregate purchase price comprised of $ 85 million in cash for the enterprise value of FibroGen International, plus an additional cash amount equal to the net cash held in China by FibroGen International and its subsidiaries as of the closing. This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1 % interest in 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 SAMR. 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, Company determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with FASB ASC 205, Presentation of Financial Statements , as of June 30, 2025 and December 31, 2024. Accordingly, the operating results related to the FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations, while the related assets and liabilities were classified within the condensed consolidated balance sheets as held for sale for all periods presented.
The financial results of the discontinued operations with respect to FibroGen International reflected in the condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 were as follows (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Revenue:
Product revenue, net
$
19,655
49,643
$
59,472
$
80,181
Operating costs and expenses:
Cost of goods sold
4,290
5,038
9,692
9,448
Research and development
542
1,746
1,301
3,650
Selling, general and administrative
6,074
7,370
13,538
13,475
Total operating costs and expenses
10,906
14,154
24,531
26,573
Income from operations
8,749
35,489
34,941
53,608
Interest and other, net
Interest expense
( 2,964
)
( 2,915
)
( 5,915
)
( 5,819
)
Interest income and other income (expenses), net
( 1,367
)
( 2,181
)
( 2,649
)
( 1,846
)
Total interest and other, net
( 4,331
)
( 5,096
)
( 8,564
)
( 7,665
)
Income before income taxes
4,418
30,393
26,377
45,943
Provision for income taxes
—
19
—
45
Investment income in unconsolidated variable interest entity
1,662
1,177
1,108
1,766
Income from discontinued operations, net of tax
$
6,080
$
31,551
$
27,485
$
47,664
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 .
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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
Assets
Cash and cash equivalents
$
96,474
$
51,696
Accounts receivable, net
22,143
18,443
Inventories
10,871
15,547
Prepaid expenses and other current assets
3,162
25,163
Total current assets held for sale
132,650
110,849
Property and equipment, net
4,670
7,041
Equity method investment in unconsolidated variable interest entity
8,115
6,864
Operating lease right-of-use assets
1,122
1,716
Other assets
987
990
Total long-term assets held for sale
14,894
16,611
Liabilities
Accounts payable
$
123
$
26,974
Accrued and other current liabilities
7,486
10,679
Operating lease liabilities, current
849
1,264
Total current liabilities held for sale
8,458
38,917
Operating lease liabilities, non-current
156
356
Total long-term liabilities held for sale
156
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 six months ended June 30, 2025 and 2024 were as follows (in thousands):
Six Months Ended June 30,
2025
2024
Depreciation
$
530
$
753
Investment loss (income) in unconsolidated variable interest entity
( 1,108
)
( 1,766
)
Impairment of property and equipment
2,062
—
Stock-based compensation
$
943
$
884
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 $ 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.
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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 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 and six months ended June 30, 2025 and 2024.
The transaction price related to consideration received through June 30, 2025 and accounts receivable has been allocated to each of the performance obligations under the Astellas Japan Agreement, including $ 100.3 million for license and $ 17.1 million for co-development.
There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the three months ended June 30, 2025 under the Astellas Japan Agreement. 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 .
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 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.
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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. 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
Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“AstraZeneca U.S./RoW Agreement”).
On February 23, 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement, effective as of February 25, 2024 (“AstraZeneca Termination and Transition Agreement”). 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.
The Company’s collaboration agreement with AstraZeneca for roxadustat in China, as described below, remains in place.
AstraZeneca China Agreement
Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (“AstraZeneca China Agreement”). Under the terms of the AstraZeneca China Agreement, AstraZeneca agreed to pay upfront consideration and potential milestone payments, totaling $ 376.7 million . The AstraZeneca China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the AstraZeneca China Amendment as defined and discussed below, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period.
The aggregate amount of such consideration received for milestone and upfront payments through June 30, 2025 totaled $ 81.2 million .
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.
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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.
The related net product revenue recognized from the sales to Falikang was $ 16.4 million and $ 46.0 million for the three months ended June 30, 2025 and 2024, and $ 53.3 million and $ 73.1 million for the six months ended June 30, 2025 and 2024, respectively, which were included in the discontinued operations in the condensed consolidated statements of operations together with the sales directly to distributors, resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited as discussed in Note 2, Discontinued Operations .
Prior to the above-mentioned termination of the AstraZeneca U.S./RoW Agreement, the Company evaluated under the ASC 606 and accounted for the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement as a single arrangement with the presumption that two or more agreements executed with a single customer at or around the same time should be presumed to be a single arrangement. As a result of the termination of the AstraZeneca U.S./RoW Agreement, during the first quarter of 2024, the Company recorded the final development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which was immaterial.
The transaction price related to consideration received and accounts receivable through the termination of the AstraZeneca U.S./RoW Agreement has been allocated to each of the performance obligations under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, including $ 344.5 million for license, $ 625.5 million for co-development, information sharing and committee services, and $ 551.1 million for China performance obligation (with cumulative revenue of $ 408.1 million through June 30, 2025) that is recognized as product revenue, net included in discontinued operations as described under China Performance Obligation section below.
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. The China Health Authority has accepted abbreviated new drug applications for over 20 generics roxadustat applicants and approved multiple for marketing in China, since roxadustat’s inclusion in the 2023 National Reimbursement Drug List. In July 2025, roxadustat was announced as being included in the 11 th round of the China’s volume-based purchasing program whereby a national tender has been called. Any net transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized in future periods as the performance obligation is satisfied. While the related product revenue recognized is included in discontinued operations, as of June 30, 2025 and December 31, 2024, the related deferred revenues were not included in the disposal group held for sale as the related obligation to AstraZeneca will be satisfied upon the closing of the divestiture of FibroGen International.
The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands):
Balance at
December 31, 2024
Additions
Recognized
as Revenue
(Discontinued
Operations)
Currency
Translation
and Other
Balance at
June 30, 2025
AstraZeneca China performance obligation
- deferred revenue
$
( 132,097
)
$
( 63,509
)
$
53,308
$
( 649
)
$
( 142,947
)
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Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca. As of June 30, 2025 , approximately $ 20.7 million of the above deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China.
Drug Product Revenue, Net
Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and six months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2025
2024
2025
2024
Astellas Japan Agreement
$
44
$
( 366
)
$
1,825
$
( 2,571
)
Astellas Europe Agreement
1,171
1,095
1,986
2,116
AstraZeneca U.S./RoW Agreement
—
—
—
25,671
Drug product revenue, net
$
1,215
$
729
$
3,811
$
25,216
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. 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 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.
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 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.
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
June 30, 2025
Drug product revenue - deferred revenue:
Astellas Europe Agreement
$
( 9,901
)
$
1,986
$
1,327
$
( 6,588
)
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.
Eluminex Agreement
In July 2021, FibroGen exclusively licensed to Eluminex Biosciences (Suzhou) Limited (“Eluminex”) global rights to its investigational biosynthetic cornea derived from recombinant human collagen Type III. FibroGen may receive up to a total of $ 64.0 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $ 36.0 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea. FibroGen will be eligible to receive mid-single-digit to low double-digit royalties based upon worldwide net sales of cornea products, and low single-digit to mid-single-digit royalties based on worldwide net sales of other recombinant human collagen type III products that are not cornea products. In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed). The A&R Eluminex Agreement included additional total upfront payments of $ 1.5 million.
The Company received an $ 8.0 million upfront payment from Eluminex in 2022 and thereafter recognized a total of $ 6.0 million milestone payments and a total of $ 1.5 million upfront payment in 2023.
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During the first quarter of 2022, FibroGen and Eluminex entered into a separate contract manufacturing agreement, under which the Company is responsible for supplying the cornea product at cost plus 10 % of its product manufacturing costs until its manufacturing technology is fully transferred to Eluminex, which occurred by the end of 2023 . Such contract manufacturing activity was generally ceased during the first quarter of 2024.
There was no material revenue recognized under the agreements with Eluminex for the three and six months ended June 30, 2025 and 2024 .
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.
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 June 30, 2025.
Fortis has authorized and issued common shares and Series A preferred shares. As of the Option Acquisition Date and June 30, 2025 , the Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired previously and carried at zero cost. 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 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.
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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):
June 30, 2025
Level 1
Level 2
Level 3
Total
Money market funds
$
5,296
$
—
$
—
$
5,296
Commercial paper
—
12,082
—
12,082
U.S. government bonds
3,190
1,295
—
4,485
Total
$
8,486
$
13,377
$
—
$
21,863
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 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.
6. Balance Sheet Components
Cash and Cash Equivalents
Cash and cash equivalents consisted of the following (in thousands):
June 30, 2025
December 31, 2024
Cash
$
1,504
$
2,004
Commercial paper
12,082
14,269
Money market funds
5,296
28,241
U.S. government bonds
4,485
5,968
Total cash and cash equivalents
$
23,367
$
50,482
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
June 30, 2025
December 31, 2024
Insurance proceeds receivable for litigation settlement
$
—
$
28,500
Prepaid assets
1,031
1,903
Other current assets
1,275
1,139
Total prepaid expenses and other current assets
$
2,306
$
31,542
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 10, Commitments and Contingencies , for details.
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Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
June 30, 2025
December 31, 2024
Preclinical and clinical trial accruals
$
5,991
$
6,327
API and bulk drug product price true-up
12,444
13,071
Litigation settlement
—
28,500
Payroll and related accruals
4,998
4,640
Accrued restructuring charge
1,715
4,572
Professional services
6,204
2,049
Current portion of liability related to sale of future revenues
1,702
460
Other
2,862
2,416
Total accrued and other current liabilities
$
35,916
$
62,035
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 first quarter of 2025 as mentioned above. See the Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies , for details.
Responding to the reported results for pamrevlumab 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 $ 0.8 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.
7. Senior Secured Term Loan Facilities
In April 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by Morgan Stanley Tactical Value, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of (i) a $ 75.0 million initial term loan (the “Initial Term Loan”), (ii) a $ 37.5 million delayed draw term loan that will be funded upon the achievement of certain clinical development milestones (“Delayed Draw Term Loan 1”) and, (iii) an uncommitted delayed draw term loan of up to $ 37.5 million to be funded at the Lenders sole discretion, (“Delayed Draw Term Loan 2” and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the “Term Loans”).
Pursuant to the Financing Agreement, the Lenders have funded the Initial Term Loan. The clinical development milestones which could have triggered Delayed Draw Term Loan 1 were not achieved, and the Lenders have not funded Delayed Draw Term Loan 2. As such, these features expired during 2023. The Company has determined that certain other features embedded within the Loan should be bifurcated and accounted for separately as a derivative. At inception and as of June 30, 2025, the fair values of such derivatives were negligible due to the low probability of the underlying events.
The Term Loans shall accrue interest at a fixed rate of 14.0 % per annum, payable monthly in arrears. The Term Loans shall mature on May 8, 2026 . Therefore, the balance of the Term Loans was included in senior secured term loan facilities, current, under the current liabilities on the condensed consolidated balance sheet as of June 30, 2025. The Term Loans will not be subject to amortization payments. The Company is permitted to prepay the Term Loans from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Term Loans being repaid or prepaid, plus accrued and unpaid interest of the portion of the Term Loans being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Term Loans being repaid or prepaid as if such Term Loans were to remain outstanding until the scheduled maturity date.
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The initial issuance costs and the related transaction costs, totaling $ 3.7 million is amortized as interest expense using the effective interest method over the term of the Initial Term Loan and are reported on the balance sheet as a direct deduction from the amount of the Initial Term Loan. The effective annual interest rate of the Initial Term Loan was 16.13 % for the three and 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
Principal of senior secured term loan facilities
$
75,000
$
75,000
Less: Unamortized issuance costs and transaction costs
( 1,267
)
( 1,908
)
Senior secured term loan facilities, ending balance
$
73,733
$
73,092
Representing:
Senior secured term loan facilities, current
$
( 73,733
)
$
—
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 15.43 % 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
$
59,324
Interest paid
( 450
)
Interest expense recognized
4,134
Liability related to sale of future revenues - ending balance
63,008
Less: Current portion classified to accrued and other current liabilities
( 1,702
)
Liability related to sale of future revenues, non-current
$
61,306
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 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.
9. Income 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.
10. Commitments and Contingencies
Contract Obligations
As of June 30, 2025 , the Company had outstanding total non-cancelable purchase obligations of $ 3.1 million for general purchases and other programs and $ 0.5 million for manufacture and supply of roxadustat. The Company expects to fulfill its commitments under these agreements in the normal course of business, and as such, no liability has been recorded.
In addition, see Note 7, Senior Secured Term Loan Facilities and Note 8, Liability Related to Sale of Future Revenues for details of the related obligations.
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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, 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. District Court for the Northern District of California. The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for U.S. Food and Drug Administration approval. On August 30, 2021, the Court consolidated the actions and appointed a group of lead plaintiffs. On October 17, 2023, the parties reached an agreement in principle to settle the class action at $ 28.5 million. Accordingly, as of December 31, 2024, the Company recorded the $ 28.5 million in accrued and other current liabilities on the condensed consolidated balance sheet. The Company maintains insurance that covers exposure related to the class action lawsuit. As the amount is fully recoverable under the Company’s insurance policies, the Company recorded a corresponding receivable in prepaid expenses and other current assets on the condensed consolidated balance sheet as of December 31, 2024. The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers. The Court preliminarily approved the settlement on February 13, 2024 and approved the settlement Plan of Allocation on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024, reserving further orders on the final judgment until after the claims and distribution process was completed. The court entered a class distribution order on January 1, 2025 and the amount was fully distributed during the first quarter of 2025. As a result, the related accrued liability and the corresponding receivable were fully settled in the same period. Another case, filed on May 25, 2023, against the same defendants, asserting similar claims as the class action and additional common-law and California state fraud claims was voluntarily dismissed on December 20, 2023.
Between July 30, 2021 and April 3, 2024, seven shareholder derivative complaints were filed, naming as defendants certain of the Company’s current and former officers and certain current and former members of the Company’s board, as well as FibroGen as nominal defendants (the “Derivative Lawsuits”). Of these Derivative Lawsuits, four were filed in the Delaware Court of Chancery, two were filed in the U.S. District Court for the District of Delaware (the “Delaware Federal Derivative Actions”), and one was filed in the U.S. District Court for the Northern District of California (the “California Federal Derivative Action”). The plaintiffs assert state and federal claims based on some of the same alleged misstatements as the securities class action complaint. The complaints seek unspecified damages, attorneys’ fees, and other costs. All seven Derivative Lawsuits have been dismissed.
In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data. The SEC followed up with a subpoena for additional documents in the second quarter of 2024. In May 2025, the Company entered into a settlement with the SEC, subject to Commission approval. As part of the settlement, and without admitting or denying the findings in the settlement offer or administrative order to be issued by the SEC, the Company agreed to pay a $ 1.25 million civil penalty.
Between 2022 and 2024, the Company’s Board of Directors received seven litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the pending derivative and securities class action lawsuits. The Company may in the future receive additional similar demands.
Starting in October 2021, certain challenges have been filed with the China National Intellectual Property Administration against patents which claim a crystalline form of roxadustat. Final resolution of such proceedings will take time and the Company could not predict the ultimate outcome, or reasonably estimate the potential exposure.
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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. The Company believes the estimated fair value of these arrangements is minimal.
11. 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 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.
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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.