Item 7. Management’s Discussion and Analysis
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes and other financial information included in Item 8 of this Annual Report on Form 10-K for the year ended December 31, 2025 (“Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report, including information with respect to our plans and strategy for our business, international operations and product candidates, includes forward-looking statements that involve risks and uncertainties. You should review the “Forward-Looking Statements” and ““Risk Factors” sections of this Annual Report for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Unless noted otherwise, this management’s discussion and analysis relates solely to our continuing operations and does not reflect the operations results of FibroGen International (defined below), which is reflected as discontinued operations in our Consolidated Financial Statements.
BUSINESS OVERVIEW
Kyntra Bio, Inc. (“Kyntra Bio” or “we”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
In January 2026, we announced our rebranding from “FibroGen, Inc.” to “Kyntra Bio, Inc.”, representing the next step of its transformation and focus on oncology and associated rare disease indications. On January 8, 2026, our common stock began trading under the new Nasdaq symbol “KYNB.”
We are 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. We initiated a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory sub-study of FG-3180, in the third quarter of 2025.
We and our collaboration partners developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in Europe, Japan, the People’s Republic of China (“China”), 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, we closed the sale of our China operations through FibroGen International (Hong Kong) Ltd. (“FibroGen International”) to AstraZeneca Treasury Limited pursuant to the share purchase agreement entered into with AstraZeneca Treasury Limited on February 20, 2025, as amended (the “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 our long-time commercialization partner for roxadustat in greater China. This sale included all of our 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”).
Kyntra Bio 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.
We continue to advance our development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need. We 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 patient inclusion criteria. We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. We submitted the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden to the FDA in December 2025.
The FDA granted Roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.
53
Financial Highlights
Years Ended December 31,
2025
2024
(in thousands, except for per share data)
Result of Operations
Revenue
$
6,440
$
29,621
Operating costs and expenses
52,335
180,037
Loss from continuing operations
(58,204
)
(153,098
)
Loss from continuing operations per share - basic and diluted
$
(14.40
)
$
(38.26
)
December 31, 2025
December 31, 2024
(in thousands)
Balance Sheet
Cash and cash equivalents
$
47,872
$
50,482
Short-term investments
41,106
—
Accounts receivable
216
481
Long-term investments
$
20,160
$
—
Our revenue for the year ended December 31, 2025 primarily included $5.8 million of drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas.
As comparison, our revenue for the year ended December 31, 2024 primarily included the revenues recognized related to the following:
• $25.7 million cumulative catch-up net adjustment in the drug product revenue, as a result of terminating the AstraZeneca U.S./RoW Agreement (as defined below), effective as of February 25, 2024 as amended and restated on August 29, 2025 (“AstraZeneca Termination and Transition Agreement”), with the exception of South Korea.
• $2.0 million of drug product revenue related to API deliveries to Astellas; and
• $1.8 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca.
Total operating costs and expenses decreased $127.7 million for the year ended December 31, 2025 compared to the prior year as a result of the net effect of the following:
• $25.8 million lower employee-related expenses primarily due to the impact from reduction in force actions in August 2024 and July 2023, and cost control efforts;
• $23.8 million lower facilities-related expenses due to cost control efforts and lower depreciation expense as certain property and equipment reached their useful lives in prior year period, offset by the loss on disposal of property and equipment associated with efforts to streamline operations;
• $18.9 million restructuring charge related to the reduction in force plan in August 2024 recorded in prior year, which did not recur in 2025;
• $17.1 million lower stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units due to reduced headcount;
• $16.9 million lower clinical trial expenses primarily associated with the termination of pamrevlumab programs during the second half of 2024 responding to the topline clinical data results we reported in July 2024;
• $15.0 million cost of goods sold corresponding to the drug product revenue resulting from the AstraZeneca Termination and Transition Agreement in 2024 related to the AstraZeneca U.S./RoW Agreement (as defined below), which did not recur in 2025; and
• $8.0 million lower drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated.
54
Our research and development expenses were $23.5 million and $95.7 million for the years ended December 31, 2025 and 2024, respectively. Since inception and through December 31, 2025, we have incurred a total of approximately $3.3 billion in research and development expenses, a majority of which relates to the development of roxadustat, pamrevlumab, FG-3246 and other hypoxia-inducible factor prolyl hydroxylase inhibitors. We expect to incur significant expenses and operating losses over at least the next few years as we continue to make investments in research and development to advance our current product candidate portfolio. We consider the active management and development of our clinical pipeline to be particularly crucial to our long-term success. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time consuming. We implemented cost reduction efforts in 2024 in connection with our efforts to streamline operations to align with our business goals. As a result, operating expenses have decreased and may continue to decrease in certain areas over time.
During the year ended December 31, 2025, we had a loss from continuing operations of $58.2 million or loss from continuing operations per basic and diluted share of $14.40, as compared to a loss from continuing operations of $153.1 million, or loss from continuing operations per basic and diluted share of $38.26 for the prior year, primarily due to a decrease in operating costs and expenses, offset by a decrease in revenues.
Consolidated cash and cash equivalents, investments and accounts receivable totaled $109.4 million at December 31, 2025, an increase of $58.4 million from December 31, 2024. Upon the the close of our sale of FibroGen International to AstraZeneca Treasury Limited during the third quarter of 2025, we accessed the entirety of our cash and cash equivalents held in China. For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the consolidated financial statement, and the Liquidity and Capital Resources section below. Comparatively, consolidated cash and cash equivalents and accounts receivable for both continuing operations and discontinued operations totaled $121.1 million at December 31, 2024.
Collaboration Partnerships for Roxadustat
Our current and future research, development, manufacturing and commercialization efforts with respect to roxadustat depend on funds from our collaboration agreements with Astellas and AstraZeneca. See Note 4, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details.
Astellas
In June 2005, we 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”). In April 2006, we entered into the Europe Agreement with Astellas for roxadustat for the treatment of anemia in Europe, the Commonwealth of Independent States, the Middle East, and South Africa (“Astellas Europe Agreement”). Under these agreements, the aggregate amount for upfront payments and milestone payments received through December 31, 2025 totals $790.1 million. Based on the current development plans for roxadustat in Japan and Europe, we do not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement or the Astellas Europe Agreement.
In 2018, we 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 was $0.8 million and $(2.9) million for the years ended December 31, 2025 and 2024, respectively.
During the first quarter of 2021, we entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from us in support of commercial supplies (the “Astellas EU Supply Agreement”). The related drug product revenue was $5.1 million and $4.9 million for the years ended December 31, 2025 and 2024, respectively.
AstraZeneca
In July 2013, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in the U.S. and all territories except for China and those territories previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”). In 2020, we entered into a Master Supply Agreement with AstraZeneca under the AstraZeneca U.S./RoW Agreement (the “AstraZeneca Master Supply Agreement”) to define general forecast, order, supply and payment terms for AstraZeneca to purchase roxadustat bulk drug product from Kyntra Bio in support of commercial supplies.
55
In February 2024, we entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement with AstraZeneca, as amended and restated on August 29, 2025. Pursuant to the AstraZeneca Termination and Transition Agreement, AstraZeneca returns all of their non-China roxadustat rights to us, 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 Kyntra Bio’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue Kyntra Bio 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. In addition, resulting from the AstraZeneca Termination and Transition Agreement, Kyntra Bio and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement. Accordingly, during the first quarter of 2024, we recorded a cumulative catch-up net adjustment of $25.7 million to the drug product revenue.
In July 2013, through our China subsidiary and related affiliates, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”). The aggregate amount for upfront payments and milestone payments received through December 31, 2025 totals $81.2 million.
On August 29, 2025, we closed the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement. For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the consolidated financial statements.
AstraZeneca China Amendment
In July 2020, FibroGen China and AstraZeneca (together with FibroGen China, the “Parties”) entered into an amendment, effective July 1, 2020, 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 conduct sales and marketing through AstraZeneca.
W e accounted for our investment in Falikang under the equity method, and Falikang was not consolidated into our consolidated financial statements. Our proportionate share of the reported profits or losses of Falikang, was included in the discontinued operations in the consolidated statement of operations, and the investment in unconsolidated subsidiary is included the held for sale assets in the consolidated balance sheet as of December 31, 2024. See Note 3, Discontinued Operations and Divestiture , to the consolidated financial statements for details.
Product revenue, net, which was included in the discontinued operations, consisted primarily of revenues from sales of roxadustat commercial product to Falikang.
Substantially all direct roxadustat product sales to distributors in China were 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 transaction price, adjusted for the estimated profit share.
We recognized revenue upon the transfer of control of commercial products to Falikang in an amount that reflected the allocation of transaction price of the China manufacturing and supply obligation (“China Performance Obligation”) to the performance obligation satisfied during the reporting period. For our direct sales of commercial drug product, we recognized revenue when control of the promised good was transferred to the customer in an amount that reflected the consideration that we expected to be entitled to in exchange for the product. As discussed in Note 3, Discontinued Operations and Divestiture, to the consolidated financial statements, 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 third quarter of 2025. During the years ended December 31, 2025 and 2024, included in the discontinued operations, we recognized $218.6 million and $159.0 million of net product revenue from the sales to Falikang, and $8.1 million and $14.7 million of net product revenue from sales directly to distributors in one province in China, respectively.
Licensing Activities
Exclusive License with Eluminex
In April 2023, we entered into an Amended and Restated Exclusive License Agreement with Eluminex (“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).
56
RESULTS OF OPERATIONS
Revenue
Years Ended December 31,
Change
2025
2024
$
%
(dollars in thousands)
Revenue:
Development and other revenue
592
1,948
(1,356
)
(70
)
%
Drug product revenue, net
5,848
27,673
(21,825
)
(79
)
%
Total revenue
$
6,440
$
29,621
$
(23,181
)
(78
)
%
Under our revenue recognition policy, development revenue includes co-development and other development related services. We recognize development services as revenue in the period in which they are billed to our partners, excluding China. As of December 31, 2025, we do not expect to incur significant future co-development services. Other revenues consist of contract manufacturing revenue, patent transfer and sales of research and development material, which have not been material for any of the periods presented. Development and other revenues represented 9% and 7% of total revenues for the years ended December 31, 2025 and 2024, respectively.
Drug product revenue includes commercial-grade API or bulk drug product sales to AstraZeneca, under the AstraZeneca U.S./RoW Agreement, and Astellas in support of pre-commercial preparation prior to the new drug application or marketing authorization application approval, and to Astellas for ongoing commercial activities in Japan and Europe. We recognize drug product revenue when we fulfill the inventory transfer obligations. The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received in the future may differ from our estimates, for which we will adjust these estimates and affect the drug product revenue in the period such variances become known. Drug product revenues represented 91% and 93% of total revenues for the years ended December 31, 2025 and 2024, respectively.
The AstraZeneca U.S./RoW Agreement was terminated on February 25, 2024 (except for South Korea). On August 29, 2025, we closed the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement. For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the consolidated financial statements. In the future, we will continue generating revenue from collaboration agreements in the form of milestone payments and royalties on drug product sales. We expect that any revenues we generate will fluctuate from quarter to quarter due to the uncertain timing and amount of such payments and sales.
Total revenue decreased $23.2 million or 78% for the year ended December 31, 2025 compared to the year ended December 31, 2024 for the reasons discussed in the sections below.
Development and Other Revenue
Years Ended December 31,
Change
2025
2024
$
%
(dollars in thousands)
Development revenue:
Astellas
$
592
$
1,413
$
(821
)
(58
)
%
AstraZeneca
—
418
(418
)
NM
Total development revenue
592
1,831
(1,239
)
(68
)
%
Other revenue
—
117
(117
)
NM
Total development and other revenue
$
592
$
1,948
$
(1,356
)
(70
)
%
________________________
NM = Not meaningful
Development and other revenue decreased $1.4 million, or 70% for the year ended December 31, 2025 compared to the year ended December 31, 2024, mainly due to the decrease in co-development billings resulting from the closeout activities under our collaboration agreements with Astellas for roxadustat.
57
Drug Product Revenue
Years Ended December 31,
Change
2025
2024
$
%
(dollars in thousands)
Drug product revenue, net:
Astellas Japan Agreement
$
793
$
(2,872
)
$
3,665
128
%
Astellas Europe Agreement
5,055
4,874
181
4
%
AstraZeneca U.S./RoW Agreement
—
25,671
(25,671
)
NM
Total drug product revenue, net:
$
5,848
$
27,673
$
(21,825
)
(79
)
%
________________________
NM = Not meaningful
Drug product revenue decreased $21.8 million, or 79% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
Astellas Japan Agreement
We updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment and accordingly recorded an adjustment to the drug product revenue of $0.8 million for the year ended December 31, 2025. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas and foreign exchange impacts, among others.
We updated our 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 $2.9 million for the year ended December 31, 2024. Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas and foreign exchange impacts, among others.
As of December 31, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $1.6 million in accrued liabilities, representing our best estimate of the timing for these amounts to be paid. As of December 31, 2024, the related balances were $2.5 million in accrued liabilities and $0.6 million in other long-term liabilities.
Astellas Europe Agreement
During the fourth quarter of 2025, we 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 $0.3 million as drug product revenue, and recorded $2.2 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes. In addition, we updated our 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, 2025, we reclassified $1.8 million from the related deferred revenue to accrued liabilities. As of December 31, 2025, the related balance in accrued liabilities was $5.4 million, representing our best estimate that this amount will be paid within the next 12 months.
During the fourth quarter of 2024, we 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, we updated our 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, we 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, and we paid $7.1 million to Astellas during the year ended December 31, 2025.
58
In addition, we recognized royalty revenue of $4.8 million and $4.3 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement for the years ended December 31, 2025 and 2024, respectively. The remainder of the deferred revenue will be recognized as and when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.
AstraZeneca U.S./RoW Agreement
As described above, pursuant to the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, Kyntra Bio and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement. Accordingly, during the first quarter of 2024, we 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.
Operating Costs and Expenses
Years Ended December 31,
Change
2025
2024
$
%
(dollars in thousands)
Operating costs and expenses
Cost of goods sold
$
556
$
15,561
$
(15,005
)
(96
)
%
Research and development
23,517
95,692
(72,175
)
(75
)
%
Selling, general and administrative
27,709
49,330
(21,621
)
(44
)
%
Restructuring charge
553
19,454
(18,901
)
(97
)
%
Total operating costs and expenses
$
52,335
$
180,037
$
(127,702
)
(71
)
%
Total operating expenses decreased $127.7 million, or 71% for the year ended December 31, 2025 compared to the year ended December 31, 2024, for the reasons discussed in the sections below.
Cost of goods sold
Cost of goods sold decreased $15.0 million or 96% for the year ended December 31, 2025 compared to the year ended December 31, 2024.
As described above, during the year ended December 31, 2024, we recorded a cumulative catch-up net adjustment to the drug product revenue resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement. Correspondingly, we recorded the related cost of goods sold of $14.6 million during the year ended December 31, 2024.
Cost of goods sold associated with the roxadustat drug product revenue in the U.S. was $0.3 million and $0.8 million for the years ended December 31, 2025 and 2024, respectively, associated with the costs of API or bulk drug product delivered to Astellas and AstraZeneca in the respective periods.
Research and Development Expenses
Research and development expenses consist of independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development expenses include employee-related expenses for research and development functions, expenses incurred under agreements with clinical research organizations, other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. We expense research and development costs as incurred. We recognize costs for certain development activities based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites. We have implemented a significant cost reduction plan in the U.S. in the third quarter of 2024. As a result, research and development expenses have overall decreased and may continue to decrease in certain areas over time.
59
The following table summarizes our research and development expenses incurred during the years ended December 31, 2025 and 2024:
Phase of
Years Ended December 31,
Product Candidate
Development
2025
2024
(in thousands)
FG-3246
Phase 2
$
14,087
$
20,484
Roxadustat
Approved / Phase 3
2,837
6,527
Pamrevlumab
Phase 2/3
2,373
49,696
Other research and development expenses
4,220
18,985
Total research and development expenses
$
23,517
$
95,692
The program-specific expenses summarized in the table above include costs we directly attribute to our product candidates. We allocate research and development salaries, benefits, stock-based compensation and other indirect costs to our product candidates on a program-specific basis, and we include these costs in the program-specific expenses.
Research and development expenses decreased $72.2 million, or 75% for the year ended December 31, 2025 compared to the year ended December 31, 2024 as a result of the net effect of the following:
• Decrease of $19.2 million in facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;
• Decrease of $16.9 million in clinical trials costs primarily associated with the termination of pamrevlumab programs during the second half of 2024 responding to the topline clinical data results we reported in July 2024;
• Decrease of $16.0 million in employee-related costs primarily due to the impact from reduction in force actions in August 2024, and cost control efforts;
• Decrease of $9.7 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units due to reduced headcount and terminations; and
• Decrease of $8.0 million in drug development expenses associated with drug substance activities related to pamrevlumab programs which were completed and terminated.
Selling, General and Administrative Expenses
Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance, and human resource functions. SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents. We have implemented a significant cost reduction plan in the U.S. in the third quarter of 2024. As a result, SG&A expenses have overall decreased and may continue to decrease over time.
SG&A expenses decreased $21.6 million, or 44% for the year ended December 31, 2025 compared to the year ended December 31, 2024, as a result of the net effect of the following:
• Decrease of $9.8 million in employee-related costs primarily due to the impact from reduction in force action in August 2024 and cost control efforts due to reduced headcount and terminations;
• Decrease of $7.4 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units; and
• Decrease of $4.6 million in facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024.
Restructuring Charge
In response to the topline clinical results for pamrevlumab in patients with pancreatic cancer we announced in July 2024, we implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously winding down remaining obligations, and reducing our U.S. workforce by approximately 75%. As a result, we recorded a total of $19.5 million non-recurring restructuring charge during the year
60
ended December 31, 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions. The related restructuring charges for the year ended December 31, 2025 were not material.
Interest and Other, Net
Years Ended December 31,
Change
2025
2024
$
%
(dollars in thousands)
Interest and other, net:
Interest expense
$
(8,759
)
$
(8,247
)
$
(512
)
6
%
Loss on debt extinguishments
(6,583
)
—
(6,583
)
100
%
Interest income and other income (expenses), net
2,943
5,296
(2,353
)
(44
)
%
Total interest and other, net
$
(12,399
)
$
(2,951
)
$
(9,448
)
320
%
Interest Expense
Interest expense represents the interest associated with the liability related to sale of future revenues and interest related to the Technology Development Center of the Republic of Finland product development obligations.
Interest expense remained relatively flat for the year ended December 31, 2025 compared to the year ended December 31, 2024, and primarily included interest expense of $8.4 million and $7.9 million, respectively, related to sale of future revenues under a revenue interest financing agreement (the “RIFA”) with NQ Project Phoebus, L.P. (“NovaQuest”) entered into in November 2022. See Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details.
Loss on Debt Extinguishments
On August 29, 2025, upon the above-mentioned completion of the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited, we paid a total of $80.9 million to Morgan Stanley Tactical Value (“MSTV”), 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 prepayment premium and fees. Accordingly, we recorded a loss on debt extinguishments of $6.6 million for the year ended December 31, 2025. See Note 8, Senior Secured Term Loan Facilities , to the consolidated financial statements for details.
Interest Income and Other Income (Expenses), Net
Interest income and other income (expenses), net primarily include interest income earned on our cash, cash equivalents and investments, foreign currency transaction gains (losses), remeasurement of certain monetary assets and liabilities in non-functional currency into the functional currency, realized gains (losses) on sales of investments, and other non-operating income and expenses.
Interest income and other income (expenses), net decreased $2.4 million, or 44%, for the year ended December 31, 2025 compared to the year ended December 31, 2024, primarily due to lower interest income resulting from lower investment balances.
Benefits from Income Taxes
Years Ended December 31,
2025
2024
(dollars in thousands)
Loss from continuing operations before income taxes
$
(58,294
)
$
(153,367
)
Benefit from income taxes
(90
)
(269
)
Effective tax rate
0.2
%
0.2
%
The benefits from income taxes for each of the two years ended December 31, 2025 were due to foreign taxes.
61
Based upon the weight of available evidence, which includes our historical operating performance, reported cumulative net losses since inception and expected continuing net loss, we have established a full valuation allowance against our net deferred tax assets as we do not currently believe that realization of those assets is more likely than not. We intend to continue maintaining a full valuation allowance on our deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this allowance.
Discontinued Operations
On February 20, 2025, we entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which we and our 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 transaction was closed on August 29, 2025.
We determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with Financial Accounting Standard Boards Accounting Standards Codification ASC 205, Presentation of Financial Statements , as of December 31, 2024. Accordingly, the operating results related to FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the consolidated statements of operations. See Note 3, Discontinued Operations and Divestiture , for details.
LIQUIDITY AND CAPITAL RESOURCES
Financial Conditions
We have historically funded our operations principally from the sale of common stock (including our public offering proceeds), from the execution of collaboration agreements involving license payments, milestone payments, reimbursement for development services, and the associated product revenue and drug product revenue.
Upon the close of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we received $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. On November 6, 2025, we 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. See Note 3, Discontinued Operations and Divestiture , to the consolidated financial statements for details.
In April 2023, we entered into a financing agreement with investment funds managed by MSTV (“Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of a $75.0 million 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. Upon the closing of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we repaid our term loan facility with the Lenders. See Note 8, Senior Secured Term Loan Facilities , to the consolidated financial statements for details.
In November 2022, we entered into a RIFA with NovaQuest with respect to our revenues from Astellas’ sales of roxadustat in Europe, Japan and the other Astellas territories. Pursuant to the RIFA, in the fourth quarter of 2022, we received $49.8 million from NovaQuest, representing the gross proceeds of $50.0 million net of initial issuance costs, in consideration for a portion of future revenues we will receive from Astellas. For additional details about this financing transaction, see Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements.
In February 2025, we entered into an Equity Distribution Agreement with BofA Securities, Inc. pursuant to which we may issue and sell, from time to time and through BofA Securities, Inc., shares of our common stock having an aggregate offering price of up to $30.0 million. We did not sell any shares of common stock under this agreement during the year ended December 31, 2025.
62
Cash and cash equivalents, investments and accounts receivable totaled $109.4 million as of December 31, 2025, compared to $50.5 million as of December 31, 2024. Cash is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Investments, consisting of available-for-sale securities, and stated at fair value, are also available as a source of liquidity. Upon the close of our sale of FibroGen International to AstraZeneca during the third quarter of 2025, we accessed the entirety of our cash and cash equivalents held in China.
Cash Sources and Uses
The following table summarizes the primary sources and uses of cash for the years ended December 31, 2025 and 2024 (in thousands), including both continuing operations and discontinued operations:
Years Ended December 31,
2025
2024
Net cash provided by (used in):
Operating activities
$
(4,774
)
$
(137,999
)
Investing activities
35,419
125,993
Financing activities
(86,028
)
(255
)
Effect of exchange rate changes on cash and cash equivalents
1,077
751
Net decrease in cash and cash equivalents
$
(54,306
)
$
(11,510
)
Operating Activities
Net cash used in operating activities was $4.8 million for the year ended December 31, 2025 and consisted primarily of net income of $183.5 million, adjusted for non-cash items and non-operating activities of $35.2 million and a net decrease in operating assets and liabilities of $153.0 million. The significant non-cash items included gain on divesture of FibroGen International of $52.6 million, loss on debt extinguishments of $6.6 million and stock-based compensation expense of $6.6 million. The significant items in the changes in operating assets and liabilities included the following:
• Deferred revenue decreased $136.4 million, due to the recognition of all the previously deferred balance related to our China Performance Obligation under our agreements with AstraZeneca upon the completion of the divestiture of FibroGen International on August 29, 2025, as the performance obligation to AstraZeneca were completely satisfied upon the closing of the divestiture. See the China Performance Obligation section in Note 4, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details;
• Accrued and other liabilities decreased $53.5 million, primarily driven by the $28.5 million distribution of litigation settlement related to our agreement in principle with plaintiffs to settle the class action lawsuit, $7.8 million payment of the transaction costs related to the divestiture, $7.3 million total payments of bonus and severance payouts, and $7.1 million payment to Astellas related to accrued API and bulk drug product price true-up. The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment.
• Accounts payable decreased $27.7 million, primarily driven by the payments made during the current year to AstraZeneca under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items.
• Prepaid expenses and other current assets decreased $54.1 million, primarily due to the $28.5 million distribution of the above-mentioned litigation settlement during the year, which is fully recoverable under our insurance policies. The decrease in prepaid expenses and other current assets was also related to the collection from Falikang during the current year period based on the arrangements under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, which was unbilled receivables as of December 31, 2024;
• Accrued interest expense related to sale of future revenues increased $8.0 million due to the interest expense of $8.4 million accrued, offset by the interest paid of $0.5 million during the period. See Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details; and
• Inventory decreased $5.4 million primarily driven by lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China in late 2024. Inventory in China was part of the held-for-sale assets as of December 31, 2024 as discussed in Note 3, Discontinued Operations and Divestiture, to the consolidated financial statements.
63
Net cash used in operating activities was $138.0 million for the year ended December 31, 2024 and consisted primarily of net loss of $47.6 million adjusted for non-cash items and non-operating activities of $27.0 million and a net decrease in operating assets and liabilities of $117.5 million. The significant non-cash items included stock-based compensation expense of $25.2 million. The significant items in the changes in operating assets and liabilities included the following:
• Accrued and other liabilities decreased $93.8 million, driven by payment of $35.3 million to Astellas and $11.5 million to AstraZeneca related to accrued API and bulk drug product price true-up, bonus and severance payouts totaling $35.6 million, and settlement of historical co-promotion balances under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca. The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment.
• Operating lease right-of-use assets decreased $66.3 million, operating lease liabilities, non-current decreased $66.2 million and operating lease liabilities, current decreased $12.8 million related to the operating lease termination of our corporate headquarters;
• Deferred revenue decreased $28.3 million, primarily related to the $46.7 million product revenue recognized, which is included in the discontinued operations, from the previously deferred revenue of the China Performance Obligation during the year. In addition, the decrease in deferred revenue was also related to the reclassification of $7.2 million to accrued liabilities, resulting from changes in estimated variable consideration associated with the bulk drug product transferred to Astellas under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement during the year. The decreases were offset by the impact that deferred revenue was no longer netted against any contract assets as of December 31, 2024, as the $22.5 million of unbilled co-development revenue under the AstraZeneca China Amendment and the $4.0 million unbilled regulatory milestone payment under the AstraZeneca China Agreement as of December 31, 2023 were billed during the third quarter of 2024 under the above-mentioned settlement agreements;
• Prepaid expenses and other current assets increased $15.6 million, primarily due to the unbilled receivables from Falikang based on the arrangements under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, offset by the reimbursements from the insurance for the legal fees associated with the class action lawsuit, which is recoverable under our insurance policies.
• Accounts receivable increased $6.7 million, primarily driven by the billings to Falikang based on the arrangements under the above-mentioned settlement agreements and related to the increase product sales, as well as the timing of receipt of the billings under our collaboration and license agreements. Accounts receivable from Falikang is part of the held-for-sale assets resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited;
• Inventory decreased $22.3 million primarily driven by the $12.6 million of work-in-progress inventory that was reimbursed as part of the above-mentioned termination of the AstraZeneca U.S./RoW Agreement, and lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China, and intend to manufacture API for China at Shanghai SynTheAll Pharmaceutical Co., Ltd. (“WuXi STA”). Inventory in China is part of the held-for-sale assets resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited; and
• Accounts payable increased $14.5 million, primarily driven by the payments to be made for the historical co-promotion expenses to AstraZeneca during the current year, which is part of the held-for-sale liabilities resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited. The increase was offset by timing of invoicing and payments and cost control efforts.
Investing Activities
Investing activities primarily consist of net proceeds from divestiture, purchases of investments, and proceeds from the maturity and sale of investments.
Net cash provided by investing activities was $35.4 million for the year ended December 31, 2025 and consisted primarily of $96.6 million net proceeds from the divestiture of FibroGen International, which included the $210.4 million of cash received at closing, net of the $120.2 million cash in China at the closing that were derecognized upon the divestiture, and the $6.4 million cash received from AstraZeneca as 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; partially offset by $61.2 million of cash used in purchases of available-for-sale securities.
Net cash provided by investing activities was $126.0 million for the year ended December 31, 2024 and consisted primarily of $133.8 million of proceeds from maturities of investments, partially offset by $8.6 million of cash used in purchases of available-for-sale securities.
64
Financing Activities
Financing activities primarily reflect proceeds from strategic financing arrangements, proceeds from the issuance of our common stock, and cash paid for payroll taxes on restricted stock unit releases.
Net cash used in financing activities was $86.0 million for the year ended December 31, 2025, and consisted primarily of $75.0 million of cash used to pay off our senior secured term loan facilities with MSTV and $5.5 million of cash paid for the related premium and fees associated with the early pay-off. See Note 8, Senior Secured Term Loan Facilities , to the consolidated financial statements for details. Net cash used in financing activities also included $5.4 million of cash paid to FibroGen Cayman’s minority shareholders during the third quarter of 2025. See the Subsidiary Stock and Non-Controlling Interests - FibroGen Cayman section in Note 12, Equity and Stock-based Compensation, to the consolidated financial statements for details.
Net cash used in financing activities was not material for the year ended December 31, 2024.
Material Cash Requirements
We generate revenue from commercial sales of roxadustat product in Japan and Europe. Even with these revenues, we anticipate that we will continue to generate losses for the foreseeable future. To date, we have funded certain portions of our research and development and manufacturing efforts globally through collaboration partners, debt financings, and equity financing. We expect to continue to incur significant research and development expenses to invest in our development programs and there is no guarantee that sufficient funds will be available to continue to fund these development efforts through commercialization or otherwise. We are also subject to all the risks related to the development and commercialization of novel therapeutics, and we may encounter unforeseen expenses, difficulties, complications, delays and other factors outlined under Item 1A “ Risk Factors ” in this Annual Report on Form 10-K, as well as unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
Commitments and Contingencies
Contractual Obligations
At December 31, 2025, our material cash requirements from known contractual and other obligations primarily relate to our lease liabilities, non-cancelable purchase obligations and liability related to sale of future revenues. Expected timing of those payments are as follows (in thousands):
Payments Due In
Total
Next 12 Months
Beyond 12 Months
Purchase obligations
$
5,618
$
5,618
$
—
Liability related to sale of future revenues
118,897
1,334
117,563
Total payments
$
124,515
$
6,952
$
117,563
Our outstanding non-cancelable purchase obligations primarily related to manufacturing and supply for FG-3246 and roxadustat, and other purchases and programs. See Note 11, Commitments and Contingencies , to the consolidated financial statements for details.
Under the RIFA with NovaQuest, as of December 31, 2025, we had $67.3 million of liability related to sale of future revenues on the consolidated balance sheets, $1.3 million of which we expect to pay within the next 12 months. Based on our current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms under the RIFA, we anticipate to reach a payment cap up to $125.0 million by 2031. See Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details.
65
The table above excludes uncertain tax benefits of approximately $74.5 million that are disclosed in Note 14, Income Taxes , to the consolidated financial statements because these uncertain tax positions, if recognized, would be an adjustment to the gross deferred tax assets and the corresponding valuation allowance, if warranted.
As of December 31, 2025, we have several on-going clinical studies in various stages. Under agreements with various contract research organizations (“CROs”), and clinical study sites, we incur expenses related to clinical studies of our product candidates and potential other clinical candidates. The timing and amounts of these disbursements are contingent upon the achievement of certain milestones, patient enrollment and services rendered or as expenses are incurred by the CROs or clinical trial sites. Therefore, we cannot estimate the potential timing and amount of these payments and they have been excluded from the table above. Although our material contracts with CROs are cancelable, we have historically not canceled such contracts.
As of December 31, 2025, our FibroGen Europe Oy (“FibroGen Europe”) subsidiary had $11.1 million of principal outstanding and $8.5 million of interest accrued related to loans from the Finnish government (“TEKES” loans), respectively, which have been included as product development obligations on our consolidated balance sheet. See Note 10, Product Development Obligations , to the consolidated financial statements for details. There is no stated maturity date related to these loans and each loan may be forgiven if the research work funded by TEKES does not result in an economically profitable business or does not meet its technological objectives. In addition, we are not a guarantor of the TEKES loans, and the principal or the accrued interest of these loans are not repayable by FibroGen Europe until it has distributable funds. We do not expect FibroGen Europe to have such funds in the foreseeable future. For the foregoing reasons, we cannot estimate the potential timing and the amounts of repayments (if required) or forgiveness. As a result, the TEKES loans have been excluded from the table above.
Off-Balance Sheet Arrangements
During the year ended December 31, 2025, we did not have any relationships with unconsolidated organizations or financial partnerships, such as structured finance or special purpose entities that would have been established for the purpose of facilitating off-balance sheet arrangements.
Indemnification Agreements
We enter into standard indemnification arrangements in the ordinary course of business, including for example, service, manufacturing and collaboration agreements. Pursuant to these arrangements, we indemnify, holds harmless, and agree 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. We have entered into indemnification agreements with our directors and officers that may require us to indemnify our 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 we could be required to make under these arrangements is not determinable.
Recently Issued Accounting Guidance
For recently issued accounting guidance, see Note 2, Significant Accounting Policies, to the consolidated financial statements.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies and critical estimates are described in more detail in the notes to our financial statements appearing elsewhere in this Annual Report, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements.
66
Revenue Recognition
Drug product revenue
Drug product revenue includes commercial-grade API or bulk drug product sales to Astellas for ongoing commercial activities in Japan and Europe. We recognize drug product revenue when we fulfill the inventory transfer obligations.
The amount of variable consideration that is included in the transaction price may be constrained, and we include it in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment. We review new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material. Actual amounts of consideration ultimately received in the future may differ from our estimates, for which we will adjust these estimates and affect the drug product revenue in the period such variances become known.
As each of our collaboration agreements provide for annual true up to the considerations paid for our commercial supplies, we will re-evaluate the transaction price in each reporting period and record adjustment to revenue as uncertain events are resolved or other changes in circumstances occur.
Discontinued Operations
On February 20, 2025, we entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which we and our 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 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 two holdbacks. On November 6, 2025, we 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. We analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in our business and qualified as a discontinued operation. As a result, we determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with Financial Accounting Standard Boards Accounting Standards Codification 205, Presentation of Financial Statements (“ASC 205”), as of December 31, 2024. Accordingly, the operating results related to FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the consolidated statements of operations, while the related assets and liabilities were classified within the consolidated balance sheets as held for sale for all periods presented. See Note 3, Discontinued Operations and Divestiture , to our consolidated financial statements for related disclosures.
ITEM 7A. QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISKS
We are a smaller reporting company as defined in Rule 12b-2 of the Exchange Act; therefore, pursuant to Item 305(e) of Regulation S-K, we are not required to provide the information required by this Item.
67
ITEM 8. CONSOLIDATED FINANCIAL ST ATEMENTS AND SUPPLEMENTARY DATA
Page
Kyntra Bio, Inc.
Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
69
Financial Statements:
Consolidated Balance Sheets
71
Consolidated Statements of Operations
72
Consolidated Statements of Comprehensive Income (Loss)
73
Consolidated Statements of Changes in Redeemable Non-controlling Interests and Stockholders’ Deficit
74
Consolidated Statements of Cash Flows
75
Notes to Consolidated Financial Statements
76
Financial Statement Schedule:
II. Valuation and Qualifying Accounts for each of the two years ended December 31, 2025
111
68
Report of Independent Regis tered Public Accounting Firm
To the Board of Directors and Stockholders of Kyntra Bio, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Kyntra Bio, Inc. and its subsidiaries (the "Company") as of December 31, 2025 and 2024, and the related consolidated statements of operations, of comprehensive income (loss), of changes in redeemable non-controlling interests and stockholders’ deficit and of cash flows for the years then ended, including the related notes and financial statement schedule listed in the accompanying index for each of the years then ended (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Discontinued Operations – FibroGen International
As described in Notes 2 and 3 to the consolidated financial statements, on February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which the Company 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 the Company’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. The Company analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in the Company’s business and qualified as a discontinued operation. The operating results of FibroGen International have been reflected as discontinued operations in the consolidated financial statements for all periods presented. The Company recorded income from discontinued operations, net of tax, of $241.7 million, which included gain on divestiture of $52.6 million, for the year ended December 31, 2025.
69
The principal consideration for our determination that performing procedures relating to the discontinued operations of FibroGen International is a critical audit matter is a high degree of auditor effort in performing procedures related to the disposal transaction.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others, (i) reading the purchase and close agreements; (ii) evaluating the sufficiency of the disclosures in the consolidated financial statements; (iii) testing the gain recorded upon disposal, including obtaining and inspecting source documents, such as contracts, bank statements, and historical accounting records, and agreeing the corresponding inputs in the gain calculation and testing the mathematical accuracy of the gain calculation, and (iv) testing the completeness, accuracy and classification of certain classes of transactions included in income from discontinued operations, net, on a sample basis, by obtaining and inspecting source documents, such as contracts, purchase orders, invoices, and shipping documents.
/s/ PricewaterhouseCoopers LLP
Irvine, California
March 16, 2026
We have served as the Company’s auditor since 2000.
70
KYNTRA BIO, INC.
CONSOLIDATED B ALANCE SHEETS
(In thousands, except per share amounts)
December 31, 2025
December 31, 2024
Assets
Current assets:
Cash and cash equivalents
$
47,872
$
50,482
Short-term investments
41,106
—
Accounts receivable, net
216
481
Inventories
3,743
3,155
Prepaid expenses and other current assets
6,136
31,542
Current assets held for sale
—
110,849
Total current assets
99,073
196,509
Long-term investments
20,160
—
Other assets
361
1,405
Long-term assets held for sale
—
16,611
Total assets
$
119,594
$
214,525
Liabilities, redeemable non-controlling interests and deficit
Current liabilities:
Accounts payable
$
3,745
$
5,064
Accrued and other current liabilities
20,183
62,035
Deferred revenue
5,314
27,290
Current liabilities held for sale
—
38,917
Total current liabilities
29,242
133,306
Product development obligations
19,560
17,012
Deferred revenue, net of current
255
114,708
Senior secured term loan facilities, non-current
—
73,092
Liability related to sale of future revenues, non-current
65,980
58,864
Other long-term liabilities
82
822
Long-term liabilities held for sale
—
356
Total liabilities
115,119
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 December 31, 2025 and 2024
—
—
Common stock, $ 0.01 par value; 225,000 shares authorized at December 31, 2025 and 2024; 4,047 and 4,037 shares issued and outstanding at December 31, 2025 and 2024
1,012
1,009
Additional paid-in capital
1,677,179
1,668,620
Accumulated other comprehensive loss
( 2,182
)
( 5,732
)
Accumulated deficit
( 1,706,047
)
( 1,889,499
)
Total stockholders’ deficit attributable to Kyntra Bio
( 30,038
)
( 225,602
)
Nonredeemable non-controlling interests
13,033
20,487
Total deficit
( 17,005
)
( 205,115
)
Total liabilities, redeemable non-controlling interests and deficit
$
119,594
$
214,525
The accompanying notes are an integral part of these Consolidated Financial Statements.
71
KYNTRA BIO, INC.
CONSOLIDATED STATEM ENTS OF OPERATIONS
(In thousands, except per share amounts)
Years Ended December 31,
2025
2024
Revenue:
Development and other revenue
$
592
$
1,948
Drug product revenue, net
5,848
27,673
Total revenue
6,440
29,621
Operating costs and expenses:
Cost of goods sold
556
15,561
Research and development
23,517
95,692
Selling, general and administrative
27,709
49,330
Restructuring charge
553
19,454
Total operating costs and expenses
52,335
180,037
Loss from operations
( 45,895
)
( 150,416
)
Interest and other, net
Interest expense
( 8,759
)
( 8,247
)
Loss on debt extinguishments
( 6,583
)
—
Interest income and other income (expenses), net
2,943
5,296
Total interest and other, net
( 12,399
)
( 2,951
)
Loss from continuing operations before income taxes
( 58,294
)
( 153,367
)
Benefit from income taxes
( 90
)
( 269
)
Loss from continuing operations
( 58,204
)
( 153,098
)
Income from discontinued operations, net of tax
241,656
105,519
Net income (loss)
$
183,452
$
( 47,579
)
Loss from continuing operations per share - basic and diluted
$
( 14.40
)
$
( 38.26
)
Income from discontinued operations per share - basic and diluted
59.77
26.37
Net income (loss) per share - basic and diluted
$
45.37
$
( 11.89
)
Weighted average number of common shares used to calculate
net income (loss) per share - basic and diluted
4,043
4,002
The accompanying notes are an integral part of these Consolidated Financial Statements.
72
KYNTRA BIO, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
Years Ended December 31,
2025
2024
Net income (loss)
$
183,452
$
( 47,579
)
Other comprehensive income (loss):
Foreign currency translation adjustments
( 1,966
)
1,166
Cumulative currency translation adjustment attributable to divestiture
5,479
—
Unrealized gain (loss) on investments, net of tax effect
37
( 23
)
Other comprehensive income, net of taxes
3,550
1,143
Comprehensive income (loss)
187,002
( 46,436
)
The accompanying notes are an integral part of these Consolidated Financial Statements.
73
KYNTRA BIO, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN redeemable non-controlling interests
AND STOCKHOLDERS’ DEFICIT
(In thousands, except share data)
Common Stock
Additional
Paid-in
Accumulated
Other
Comprehensive
Accumulated
Non
Controlling
Total
Redeemable
Non-Controlling
Shares
Amount
Capital
Loss
Deficit
Interests
Deficit
Interests
(Note 5)
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
—
—
—
—
( 47,579
)
—
( 47,579
)
—
Change in unrealized
gain or loss on
investments
—
—
—
( 23
)
—
—
( 23
)
—
Foreign currency
translation
adjustments
—
—
—
1,166
—
—
1,166
—
Shares issued from
stock plans, net of
payroll taxes paid
85,869
21
( 236
)
—
—
—
( 215
)
—
Stock-based
compensation
—
—
25,215
—
—
—
25,215
—
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
—
—
—
—
183,452
—
183,452
—
Change in unrealized
gain or loss on
investments
—
—
—
37
—
—
37
—
Foreign currency
translation
adjustments
—
—
—
( 1,966
)
—
—
( 1,966
)
—
Cumulative currency
translation adjustment
attributable to
divestiture (Note 3)
—
—
—
5,479
—
—
5,479
—
Distribution to non-
controlling interest
(Note 12)
—
—
2,101
—
—
( 7,454
)
( 5,353
)
—
Shares issued from
stock plans, net of
payroll taxes paid
10,204
3
( 72
)
—
—
—
( 69
)
—
Issuance cost under
ATM Program
—
—
( 46
)
—
—
—
( 46
)
—
Redemption of fractional
shares due to reverse
stock split
( 55
)
—
—
—
—
—
—
—
Stock-based
compensation
—
—
6,576
—
—
—
6,576
—
Balance at
December 31, 2025
4,046,827
$
1,012
$
1,677,179
$
( 2,182
)
$
( 1,706,047
)
$
13,033
$
( 17,005
)
$
21,480
The accompanying notes are an integral part of these Consolidated Financial Statements.
74
KYNTRA BIO, INC.
CONSOLIDATED STATEM ENTS OF CASH FLOWS
(In thousands)
Years Ended December 31,
2025
2024
Operating activities
Net income (loss)
$
183,452
$
( 47,579
)
Adjustments to reconcile net income (loss) to net cash used in
operating activities:
Depreciation
713
2,654
Amortization of finance lease right-of-use assets
35
38
Net accretion of premium and discount on investments
( 72
)
( 1,680
)
Investment income in unconsolidated variable interest entity
( 2,485
)
( 3,969
)
Gain on divestiture
( 52,553
)
—
Loss on debt extinguishments
6,583
—
Impairment of property and equipment
2,062
—
Loss on disposal of property and equipment
—
2,551
Stock-based compensation
6,576
25,215
Dividend received from unconsolidated variable interest entity
3,947
2,230
Changes in operating assets and liabilities:
Accounts receivable, net
( 2,543
)
( 6,737
)
Inventories
5,362
22,284
Prepaid expenses and other current assets
54,102
( 15,550
)
Operating lease right-of-use assets
808
66,306
Other assets
( 902
)
1,010
Accounts payable
( 27,654
)
14,512
Accrued and other liabilities
( 53,497
)
( 93,790
)
Operating lease liabilities, current
( 568
)
( 12,774
)
Deferred revenues
( 136,429
)
( 28,297
)
Accrued interest expense related to sale of future revenues
7,990
2,257
Accrued interest for finance lease liabilities
6
14
Operating lease liabilities, non-current
( 202
)
( 66,154
)
Other long-term liabilities
495
( 540
)
Net cash used in operating activities
( 4,774
)
( 137,999
)
Investing activities
Purchases of property and equipment
( 38
)
( 266
)
Proceeds from divestiture, net of cash transferred
96,615
—
Proceeds from sale of property and equipment
—
1,046
Purchases of available-for-sale securities
( 61,158
)
( 8,628
)
Proceeds from maturities of investments
—
133,841
Net cash provided by investing activities
35,419
125,993
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
( 10
)
( 40
)
Cash paid for payroll taxes on restricted stock unit releases
( 69
)
( 354
)
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
—
139
Net cash used in financing activities
( 86,028
)
( 255
)
Effect of exchange rate change on cash and cash equivalents
1,077
751
Net decrease in cash and cash equivalents
( 54,306
)
( 11,510
)
Total cash and cash equivalents at beginning of period
102,178
113,688
Total cash and cash equivalents at end of period
$
47,872
$
102,178
Supplemental cash flow information:
Holdback consideration receivable related to divestiture in prepaid expenses and other current assets
$
4,000
$
—
Interest payments
$
7,830
$
16,207
Reconciliation of cash and cash equivalents to the consolidated balance sheets:
December 31, 2025
December 31, 2024
Cash and cash equivalents of continuing operations
$
47,872
$
50,482
Cash and cash equivalents included in assets held for sale
—
51,696
Total cash and cash equivalents in the consolidated statements of cash flows
$
47,872
$
102,178
The accompanying notes are an integral part of these Consolidated Financial Statements.
75
KYNTRA BIO, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. Th e Company
Kyntra Bio, Inc. (“Kyntra Bio” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
In January 2026, the Company announced its rebranding from “FibroGen, Inc.” to “Kyntra Bio, Inc.”, representing the next step of its transformation and focus on oncology and associated rare disease indications. On January 8, 2026, the Company’s common stock began trading under the new Nasdaq symbol “KYNB.”
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 sub-study 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 Europe, Japan, the People’s Republic of China (“China”), 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 (the “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. This sale included all of its 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”). For additional details, refer to Note 3, Discontinued Operations and Divestiture.
The Company 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 advance 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 its proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, including the starting dose and the patient inclusion criteria. The Company is starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. The Company submitted the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS and high transfusion burden to the FDA in December 2025.
The FDA granted Roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries and its majority-owned subsidiaries, as well as any variable interest entity (“VIE”) for which Kyntra Bio is the primary beneficiary. All inter-company transactions and balances have been eliminated in consolidation.
The Company operates in one reportable segment — the development and commercialization of novel therapeutics to treat serious unmet medical needs.
76
Discontinued Operations
On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which the Company 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 the Company’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1 % interest in 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 the Company’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 consolidated statements of operations for all periods presented, and therefore, the consolidated statements of operations and the notes to the 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 consolidated balance sheets as held for sale for each balance sheet date before the Transaction closed since December 31, 2024. See Note 3, Discontinued Operations and Divestiture , for related disclosures. Unless otherwise noted, discussion in the notes to the 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 consolidated financial statements and the notes to the consolidated financial statements, where applicable, to reflect the Reverse Stock Split.
Liquidity and Going Concern
The 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.
As disclosed in previous filings (including the September 30, 2024 Form 10-Q and subsequent December 31, 2024 Form 10-K, March 31, 2025 Form 10-Q and June 30, 2025 Form 10-Q), if the Company was 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 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 December 31, 2025 and concluded that the conditions and events that initially raised substantial doubt have been alleviated and that substantial doubt does not exist as of issuance.
77
Foreign Currency Translation
The reporting currency of the Company and its subsidiaries is the U.S. dollar.
The functional currency of FibroGen Europe is the Euro. The functional currency of FibroGen Beijing, a part of the above-mentioned discontinued operations, is CNY. As such, monetary assets and liabilities of FibroGen Europe and FibroGen Beijing in currencies other than their functional currencies are remeasured using exchange rates in effect at the end of the period. The assets and liabilities of FibroGen Europe and FibroGen Beijing are translated to U.S. dollars at exchange rates in effect at the balance sheet date. All income statement accounts are translated at monthly average exchange rates. Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity (deficit).
The functional currency of Kyntra Bio, Inc. and all other subsidiaries is the U.S. dollar. Accordingly, monetary assets and liabilities in the non-functional currency of these subsidiaries are remeasured using exchange rates in effect at the end of the period. Revenues and costs in local currency are remeasured using average exchange rates for the period, except for costs related to those balance sheet items that are remeasured using historical exchange rates. The resulting remeasurement gains and losses are included within interest income and other, net in the consolidated statements of operations as incurred and have not been material for all periods presented.
Use of Estimates
The preparation of the 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 (as defined and discussed under Revenue Recognition below), 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.
Concentration of Credit Risk
The Company is subject to risks associated with concentration of credit for cash and cash equivalents. Outside of short-term operating needs, cash on hand is invested in commercial paper, money market funds and U.S. government securities. Any remaining cash is deposited with major financial institutions primarily in the U.S. At times, such deposits may be in excess of insured limits. The Company has not experienced any loss on its deposits of cash and cash equivalents. As of December 31, 2025 and 2024 , the accounts receivable was not material.
Other 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.
Cash, Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents also include certain money market accounts, commercial paper and U.S. government securities.
78
Investments
As of December 31, 2025, the Company’s short-term investments consist of diversified bonds, commercial paper, and money market funds with original maturities of greater than three months and remaining maturities of less than 12 months (365 days) are considered. Any investments with maturities greater than 12 months (365 days) from the balance sheet date are considered long-term investments. When such investments are held, the Company’s investments classified as available-for-sale are recorded at fair value based upon quoted market prices at period end. Unrealized gains and losses for available-for-sale debt investments that are deemed temporary in nature are recorded in accumulated other comprehensive income (loss) as a separate component of stockholder’ equity. Realized and unrealized gains or losses resulting from changes in value and sale of the Company’s marketable equity investments are recorded in other income (expenses) in the consolidated statement of operations.
A decline in the fair value of any security below cost that is deemed other than temporary results in a charge to earnings and the corresponding establishment of a new cost basis for the security. Premiums and discounts are amortized (accreted) over the life of the related security as an adjustment to its yield. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of investments sold.
Trade accounts receivable
The allowance for credit losses is based on the Company’s assessment of the collectability of customer accounts. The Company makes estimates of expected credit losses for the allowance for doubtful accounts by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, current economic and regulatory conditions that may affect a customer’s ability to pay, and estimates of expected future losses. The Company’s bad debt expense for the years ended December 31, 2025 and 2024 and the allowance for credit losses as of December 31, 2025 and 2024 were immaterial.
Credit losses – Available-for-sale debt securities
The Company periodically assesses its available-for-sale investments for other-than-temporary impairment. For debt securities in an unrealized loss position, the Company first considers its intent to sell, or whether it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis. If either of these criteria are met, the amortized cost basis of such debt securities is written down to fair value through interest and other, net.
For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in the fair value of such debt securities has resulted from credit losses or other factors. The Company considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the securities, among other factors. If this assessment indicates that a credit loss may exist, the Company then compares the present value of cash flows expected to be collected from such securities to their amortized cost basis. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded through interest and other, net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive income.
Changes in the allowance for credit losses are recorded as provision for, or reversal of, credit loss expense. Losses are charged against the allowance when the Company believes that an available-for-sale security is confirmed uncollectable or when either of the criteria regarding intent or requirement to sell is met.
Inventories
Inventories are stated at the lower of cost or net realizable value, on a first-in, first-out, or FIFO, basis. The Company’s inventories uses actual costs to determine its cost basis. The cost of inventories includes direct material cost, direct labor and manufacturing overhead.
When the technical feasibility of the Company’s future commercialization is considered probable and the future economic benefit is expected to be realized, based on management’s judgment, the Company capitalizes pre-launch inventory costs prior to regulatory approval. A number of factors are considered, including the status in the validation process in significant jurisdictions, regulatory application and approval process, and terms and condition for future sale of such inventory or future alternative use. The pre-launch inventory cost includes purchase cost of raw materials, cost paid to contract manufacturers for inventory manufacturing, freight and custom charges, and certain direct internal labor and overhead expenses.
79
The Company periodically reviews its inventories to identify obsolete, slow-moving, excess or otherwise unsaleable items. If obsolete, excess or unsaleable items are observed and there are no alternate uses for the inventory, an inventory valuation adjustment is recorded through a charge to cost of goods sold on the Company’s consolidated statements of operations. Inventory valuation adjustments require judgment including consideration of many factors, such as estimates of future product demand and product expiration period, among others.
Variable Interest Entity
Under the Accounting Standards Codification (“ASC”) 810, Consolidation (“ASC 810”), when the Company obtains an economic interest in an entity, it evaluates the entity to determine if it should be deemed a VIE, and, if so, whether the Company is the primary beneficiary and is therefore required to consolidate the VIE, based on significant judgment whether the Company (i) has the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) has the obligation to absorb losses or the right to receive benefits of the VIE that could potentially be significant to the VIE.
On an ongoing basis, the Company re-evaluates the VIE assessment based on potential changes in facts and circumstances, including but not limited to, the shareholder loans to the entity and the execution of any future significant agreements between the entity and its shareholders and/or other third parties.
Liability Related to Sale of Future Revenues
The Company accounts for the sale of future revenue as a debt, because the risks and rewards to the investor are limited by the terms of the transaction as discussed further in Note 9, Liability Related to Sale of Future Revenues . The difference between the carrying amount of the initial liability and the gross proceeds received is accounted for as a discount. The Company recognizes interest expense based on an estimated effective annual interest rate, which is affected by the amount and timing of revenues recognized and changes in the timing of forecasted revenues. Quarterly, the Company reassesses the expected revenues and the timing of such revenues, recalculates the amortization and effective interest rate and adjusts the accounting prospectively as needed .
Revenue Recognition
Revenues under collaboration agreements
The Company’s collaboration agreements include multiple performance obligations comprised of promised services, or bundles of services, that are distinct. Services that are not distinct are combined with other services in the agreement until they form a distinct bundle of services. The Company’s process for identifying performance obligations and an enumeration of each obligation for each agreement is outlined in Note 4, Collaboration Agreements, License Agreement and Revenues . Determining the performance obligations within a collaboration agreement often involves significant judgment and is specific to the facts and circumstances contained in each agreement.
The Company has identified the following material promises under its collaboration agreements: (1) license of the Company’s technology, (2) the performance of co-development services, including manufacturing of clinical supplies and other services during the development period, and (3) manufacture of commercial supply. The evaluation as to whether these promises are distinct, and therefore represent separate performance obligations, is described in more detail in Note 4, Collaboration Agreements, License Agreement and Revenues .
For revenue recognition purposes, the Company determines that the terms of its collaboration agreements begin on the effective date and end upon the completion of all performance obligations contained in the agreements. In each agreement, the contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations. The Company believes that the existence of what it considers to be substantive termination penalties on the part of the counterparty create sufficient incentive for the counterparty to avoid exercising its right to terminate the agreement.
The transaction price for each collaboration agreement is determined based on the amount of consideration the Company expects to be entitled for satisfying all performance obligations within the agreement. The Company’s collaboration agreements include payments to the Company of one or more of the following: non-refundable upfront license fees; co-development billings; development, regulatory, and commercial milestone payments; payments from sales of active pharmaceutical ingredient (“API”); payments from sales of bulk drug product and royalties on net sales of licensed products.
80
Upfront license fees are non-contingent and non-refundable in nature and are included in the transaction price at the point when the license fees become due to the Company. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under its collaboration agreements, are considered variable consideration. Determining the reimbursable amount of research and development efforts requires detailed analysis of the terms of the collaboration agreements and the nature of the research and development efforts incurred. Prior to CKD approval in the third quarter of 2021, determining the amount of variable consideration from co-development billings required the Company to make estimates of future research and development efforts, which involved significant judgment. Co-development billings are allocated entirely to the co-development services performance obligation when amounts are related specifically to research and development efforts necessary to satisfy the performance obligation, and such an allocation is consistent with the allocation objective.
Milestone payments are also considered variable consideration, which requires the Company to make estimates of when achievement of a particular milestone becomes probable. Similar to other forms of variable consideration, milestone payments are included in the transaction price when it becomes probable that such inclusion would not result in a significant revenue reversal. Milestones are therefore included in the transaction price when achievement of the milestone becomes probable.
For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations. The SSP is determined based on observable prices at which the Company separately sells the products and services. If an SSP is not directly observable, then the Company will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available. The process for determining SSP involves significant judgment and includes consideration of multiple factors, including assumptions related to the market opportunity and the time needed to commercialize a product candidate pursuant to the relevant license, estimated direct expenses and other costs, which include the rates normally charged by contract research and contract manufacturing organizations for development and manufacturing obligations, and rates that would be charged by qualified outsiders for committee services.
81
Significant judgment may be required in determining whether a performance obligation is distinct, determining the amount of variable consideration to be included in the transaction price, and estimating the SSP of each performance obligation. An enumeration of the Company’s significant judgments is outlined in Note 4, Collaboration Agreements, License Agreement and Revenues .
For each performance obligation identified within an arrangement, the Company determines the period over which the promised services are transferred and the performance obligation is satisfied. Service revenue that was recognized over time was based on progress toward complete satisfaction of the performance obligation. For each performance obligation satisfied over time, the Company assesses the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation.
Drug product revenue
Drug product revenue includes commercial-grade API or bulk drug product sales to AstraZeneca and Astellas in support of pre-commercial preparation prior to the New Drug Application (“NDA”) or Marketing Authorization Application approval, and to Astellas for ongoing commercial activities in Japan and Europe. Drug product revenue is recognized when the Company fulfills the inventory transfer obligations.
The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgment. The Company reviews new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material. Actual amounts of consideration ultimately received in the future may differ from the Company’s estimates, for which the Company will adjust these estimates and affect the drug product revenue in the period such variances become known.
As each of the Company’s collaboration agreements provide for annual true up to the considerations paid for its commercial supplies, the Company will re-evaluate the transaction price in each reporting period and record adjustment to revenue as uncertain events are resolved or other changes in circumstances occur.
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. Falikang is jointly owned by AstraZeneca and FibroGen Beijing.
Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang. Falikang bears inventory risk once it receives and accepts the product from FibroGen Beijing, and is responsible for delivering product to its distributors.
The promises identified under the AstraZeneca China Agreement (as defined in Note 4, Collaboration Agreements, License Agreement and Revenues ), including the license, co-development services and manufacturing of commercial supplies have been bundled into a single performance obligation (“China Performance Obligation”). Amounts of the transaction price allocable to this performance obligation under the Company’s agreements with AstraZeneca as outlined in Note 4, Collaboration Agreements, License Agreement and Revenues, are deferred until control of the manufactured commercial product is transferred to AstraZeneca.
The initiation of roxadustat sales to Falikang marks the beginning of the China Performance Obligation . Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang. Revenue is recognized based on the estimated transaction price per unit and actual quantity of product delivered during the reporting period. Specifically, the transaction price per unit is determined based on the overall transaction price over the total estimated sales quantity for the estimated performance period in which the Company determined it is likely those sales would occur. The price per unit is subject to reassessment on a quarterly basis, which may result in cumulative catch up adjustments due to changes in estimates.
82
The overall transaction price for FibroGen Beijing’s product sales to Falikang includes the following elements of consideration:
• Non-refundable upfront license fees; development, regulatory, and commercial milestone payments based on the AstraZeneca China Agreement allocated to the China Performance Obligation;
• Co-development billings resulting from the Company’s research and development efforts, which are reimbursable under the AstraZeneca China Agreement;
• Interim profit/loss share between FibroGen Beijing and AstraZeneca from April 1, 2020 through December 31, 2020; and
• Net transaction price from product sales to Falikang from January 1, 2021 onwards. The net transaction price includes the following elements:
o Gross transaction price: The gross transaction price is based on a percentage of Falikang’s net sales to its distributors, which takes into account Falikang’s operating expenses and its payments to AstraZeneca for roxadustat sales and marketing efforts, capped at a percentage of Falikang’s net roxadustat sales.
o Profit share: The gross transaction price is then adjusted for an estimated amount to achieve the 50 /50 profit share from current period roxadustat net sales in China. The adjustments to date have been a reduction to the transaction price and the related accounts receivable from Falikang.
The non-refundable upfront license fees constitute a fixed consideration. The remainder of the above are variable consideration components, which may be constrained, and included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved. The calculation of the above variable consideration includes significant assumptions such as total sales quantity, performance period, gross transaction price and profit share, which require significant judgment.
Any net transaction price in excess of the revenue recognized is deferred, and will be recognized over future periods as the performance obligations are satisfied. As of December 31, 2024, the related deferred revenues were not included in the disposal group held for sale as the related obligation to AstraZeneca would be satisfied upon the closing of the divestiture FibroGen International. 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 year ended December 31, 2025. The product revenue recognized under the China Performance Obligation is included in discontinued operations for all periods presented. See Note 3, Discontinued Operations and Divestiture, for more details.
Research and Development Expenses
Research and development expenses consist of independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements. Research and development costs include employee-related expenses, expenses incurred under agreements with clinical research organizations, other clinical and preclinical costs and allocated direct and indirect overhead costs, such as facilities costs, information technology costs and other overhead. All research and development costs are expensed as incurred.
Clinical Trial Accruals
Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
Selling, General and Administrative Expenses
Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions. SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents.
83
Restructuring Charge
A restructuring charge is recognized when the liability is incurred and accrued in the period in which it is probable that the employees are entitled to the restructuring benefits and the amounts can be reasonably estimated. The restructuring liability accrued but not paid at the end of the reporting period is included in accrued and other current liabilities in the consolidated balance sheets.
Income Taxes
The Company utilizes the asset and liability method of accounting for income taxes, which requires the recognition of deferred tax assets and liabilities for expected future consequences of temporary differences between the financial reporting and income tax bases of assets and liabilities using enacted tax rates. Management makes estimates, assumptions and judgments to determine the Company’s provision for income taxes and for deferred tax assets and liabilities, and any valuation allowances recorded against the Company’s deferred tax assets. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not likely, the Company must establish a valuation allowance.
The calculation of the Company’s current provision for income taxes involves the use of estimates, assumptions and judgments while taking into account current tax laws, interpretation of current tax laws and possible outcomes of future tax audits. The Company has established reserves to address potential exposures related to tax positions that could be challenged by tax authorities. Although the Company believes its estimates, assumptions and judgments to be reasonable, any changes in tax law or its interpretation of tax laws and the resolutions of potential tax audits could significantly impact the amounts provided for income taxes in the Company’s consolidated financial statements.
The calculation of the Company’s deferred tax asset balance involves the use of estimates, assumptions and judgments while taking into account estimates of the amounts and type of future taxable income. Actual future operating results and the underlying amount and type of income could differ materially from the Company’s estimates, assumptions and judgments thereby impacting the Company’s financial position and results of operations.
The Company has adopted ASC 740-10, Accounting for Uncertainty in Income Taxes , that prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in the Company’s income tax return, and also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.
The Company includes interest and penalties related to unrecognized tax benefits within income tax expense in the Consolidated Statements of Operations.
Stock-Based Compensation
The Company maintains equity incentive plans under which equity awards are granted to employees, which are comprised of stock options, service-based restricted stock units (“RSUs”), performance-based RSUs (“PRSUs”), and total shareholder return (“TSR”) awards.
The Company measures and recognizes compensation expense for all stock options, RSUs and PRSUs granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The determination of the grant date fair value of options using the Black-Scholes valuation model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company determines the fair value of RSUs and PRSUs using the fair value of its common stock on the date of grant. To estimate the fair value of the TSR awards, the Company uses the Monte Carlo valuation model to simulate the probabilities of achievement, which requires management to make a number of assumptions including 30-day average price, volatility of the underlying stock and the Company’s peers, and the risk-free interest rate.
84
The compensation cost of service-based stock options and restricted stock units is recognized net of any estimated forfeitures on a straight-line basis over the employee requisite service period. Compensation cost for PRSUs is expensed over the respective vesting periods when the achievement of performance criteria is probable. Compensation cost for the TSR awards is recognized over the requisite service period, regardless of when, if ever, the market condition is satisfied.
The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received.
Comprehensive Income (Loss)
The Company is required to report all components of comprehensive income (loss), including net income (loss), in the consolidated financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation adjustments. Comprehensive gains (losses) have been reflected in the consolidated statements of comprehensive income (loss) for all periods presented.
Recently Adopted Accounting Guidance
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 adopted this guidance in 2025 using a prospective transition method. The adoption resulted in expanded disclosures and did not have a material impact on the Company's consolidated financial statements.
Recently Issued Accounting Guidance Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses. 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.
3. Discontinued Operations and Divestiture
On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited, pursuant to which the Company 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 the Company’s 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 consolidated statements of operations, while the related assets and liabilities were classified within the 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, which were included in the prepaid expenses and other current assets on the 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 .
85
The financial results of the discontinued operations with respect to FibroGen International reflected in the consolidated statements of operations for the years ended December 31, 2025 and 2024 were as follows (in thousands):
Years Ended December 31,
2025
2024
Revenue:
Product revenue, net
$
226,651
$
173,664
Operating costs and expenses:
Cost of goods sold
13,454
21,036
Research and development
1,739
7,375
Selling, general and administrative
14,849
32,304
Total operating costs and expenses
30,042
60,715
Income from operations
196,609
112,949
Interest and other, net
Interest expense
( 7,816
)
( 11,683
)
Gain on divestiture
52,553
—
Interest income and other income (expenses), net
( 2,173
)
423
Total interest and other, net
42,564
( 11,260
)
Income before income taxes
239,173
101,689
Provision for income taxes
—
139
Investment income in unconsolidated variable interest entity
2,483
3,969
Income from discontinued operations, net of tax
$
241,656
$
105,519
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 4, Collaboration Agreements, License Agreement and Revenues .
The gain on divestiture of $ 52.6 million resulted from the above-mentioned total consideration of $ 220.4 million and additional payment of $ 0.4 million related to the first holdback, 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.
86
The carrying value of the assets and liabilities of the discontinued operations with respect to FibroGen International on the 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 consolidated statements of cash flows for the years ended December 31, 2025 and 2024 were as follows (in thousands):
Years Ended December 31,
2025
2024
Depreciation
$
713
$
1,458
Investment income in unconsolidated variable interest entity
( 2,486
)
( 3,969
)
Gain on divestiture
( 52,553
)
—
Impairment of property and equipment
2,062
—
Dividend received from unconsolidated variable interest entity
3,947
2,230
Stock-based compensation
$
231
$
1,770
Included in the discontinued operations, Falikang, an entity jointly owned by FibroGen Beijing and AstraZeneca is an unconsolidated VIE accounted for as an equity method investment, and considered as a related party to the Company. FibroGen Beijing owns 51.1 % of Falikang’s equity.
For the years ended December 31, 2025 and 2024, the net product revenue from sales to Falikang were $ 218.6 million and $ 159.0 million , respectively. The other income from Falikang were immaterial for the years ended December 31, 2025 and 2024.
For the years ended December 31, 2025 and 2024, the investment income in Falikang was $ 2.5 million and $ 4.0 million, respectively. As of December 31, 2024, the Company’s equity method investment in Falikang were $ 6.9 million which was included in the long-term assets held for sale on the consolidated balance sheets. As of December 31, 2024 accounts receivable, net, from Falikang were $ 13.9 million which were included in the current assets held for sale on the consolidated balance sheets.
87
4. 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 the Japanese Ministry of Health, Labour and Welfare, adjusted for certain elements, after commercial launch.
The aggregate amount of the considerations received under the Astellas Japan Agreement, through December 31, 2025 totals $ 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 years ended December 31, 2025 and 2024.
The transaction price related to consideration received through December 31, 2025 and accounts receivable has been allocated to each of the performance obligations under the Astellas Japan Agreement, including $ 100.3 million for license and $ 17.1 million for co-development.
There was no license revenue or development revenue resulting from changes to estimated variable consideration in the current period relating to performance obligations satisfied or partially satisfied in previous periods for the year ended December 31, 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, the Company 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”). Under this amendment, the Company would continue to manufacture and supply roxadustat API to Astellas for the roxadustat commercial activities in Japan. The commercial terms of the Astellas Japan Agreement relating to the transfer price for roxadustat for commercial use remain substantially the same, reflecting an adjustment for the manufacture of drug product by Astellas rather than the Company. 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 . Under 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 the considerations received under the Astellas Europe Agreement through December 31, 2025 totals $ 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 years ended December 31, 2025 and 2024.
The transaction price related to consideration received through December 31, 2025 and accounts receivable has been allocated to each of the performance obligations under the Astellas Europe Agreement, including $ 619.0 million for license and $ 288.7 million for co-development.
88
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 year ended December 31, 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.
During the first quarter of 2021, the Company entered into an EU Supply Agreement with Astellas (“Astellas EU Supply Agreement”) to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from the Company in support of commercial supplies. The related drug product revenue is described under the Drug Product Revenue, Net section below.
Accounting for the Astellas Agreements
For each of the Astellas agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundles of services that are distinct.
Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual services. There are no right-of-return provisions for the delivered items in the Astellas agreements.
As of December 31, 2025, the transaction price for the Astellas Japan Agreement, excluding manufacturing services that is discussed separately below, included $ 40.1 million of non-contingent upfront payments, $ 65.0 million of variable consideration related to payments for milestones achieved, and $ 12.4 million of variable consideration related to co-development billings. The transaction price for the Astellas Europe Agreement, excluding manufacturing services that is discussed separately below, included $ 320.0 million of non-contingent upfront payments, $ 365.0 million of variable consideration related to payments for milestones achieved, and $ 222.5 million of variable consideration related to co-development billings.
For the technology license under the Astellas Japan Agreement and the Astellas Europe Agreement, SSP was determined primarily by using the discounted cash flow (“DCF”) method, which aggregates the present value of future cash flows to determine the valuation as of the effective date of each of the agreements. The DCF method involves the following key steps: 1) the determination of cash flow forecasts and 2) the selection of a range of comparative risk-adjusted discount rates to apply against the cash flow forecasts. The discount rates selected were based on expectations of the total rate of return, the rate at which capital would be attracted to the Company and the level of risk inherent within the Company. The discounts applied in the DCF analysis ranged from 17.5 % to 20.0 %. The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections by territory. Such projections included consideration of taxes and cash flow adjustments. The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases. SSP also considered certain future royalty payments associated with commercial performance of the Company’s compounds, transfer prices and expected gross margins.
The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows:
(1) License to the Company’s technology existing at the effective date of the agreements. For both of the Astellas agreements, the license was delivered at the beginning of the agreement term. In both cases, the Company concluded at the time of the agreement that its collaboration partner, Astellas, would have the knowledge and capabilities to fully exploit the licenses without the Company’s further involvement. However, the Astellas Japan Agreement has contractual limitations that might affect Astellas’ ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is capable of being distinct. The Company considered the fact that at the time of delivery of the license, the development services were beyond the preclinical development phase and any remaining development work in either agreement would not be expected to result in any significant modification or customization to the licensed technology. As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation. The portion of the transaction price allocated to this performance obligation based on a relative SSP basis was recognized as revenue in its entirety at the point in time the license transfers to Astellas.
89
(2) Co-development services (Astellas Europe Agreement). This promise relates to co-development services that were reasonably expected to be performed by the Company at the time the collaboration agreement was signed and is considered distinct. Co-development billings are allocated entirely to the co-development services performance obligation as amounts are related specifically to research and development efforts necessary to satisfy the performance obligation related to CKD approval, and such an allocation is consistent with the allocation objective. Subsequent to the approval of CKD in 2021, the Company accounts for the development services for the indications related to chemotherapy-induced anemia and MDS separately as services are provided. There w as no provision for co-development services in the Astellas Japan Agreement.
(3) License to the Company’s technology developed during the term of the agreement and development (referred to as “when and if available”) and information sharing services. These promises are generally satisfied throughout the term of the agreements.
(4) Manufacturing of clinical supplies of products. This promise is satisfied as supplies for clinical product are delivered for use in the Company’s clinical trial programs during the development period, or pre-commercialization period.
(5) Committee service . This promise is satisfied throughout the course of the agreements as meetings are attended.
Items (2)-(5) are bundled into a single performance obligation that is distinct given the fact that all are highly interrelated during the development period (pre-commercial phase of development) such that satisfying them independently is not practicable. For the revenue recognized over time based on progress toward complete satisfaction of the performance obligation, the Company uses an input method to measure progress toward the satisfaction of the performance obligation, which is based on costs of labor hours or full time equivalents and out-of-pocket expenses incurred relative to total expected costs to be incurred, and updates the measure of progress in each reporting period.
(6) Manufacturing commercial supplies of products. This promised service is distinct as services are not interrelated with any of the other performance obligations. Payments received for commercial supplies of products represent sales-based payments related predominately to the license of intellectual property under both Astellas agreements. Revenue is recognized as supplies are shipped for commercial use during the commercialization period. See the Drug Product Revenue, Net section below.
Under the Astellas Japan Amendment, the drug product revenue represents variable consideration and is estimated based on the quantity of product shipped, actual listed price for roxadustat issued by the Japanese Ministry of Health, Labour and Welfare and possible future changes to the listed price, adjusted for the timing of and estimated bulk product strength mix intended to be manufactured by Astellas, estimated cost to convert the API to bulk drug product tablets, and estimated yield from the manufacture of bulk product tablets, among others.
Under the Astellas Europe Agreement, the drug product revenue amount represents variable consideration and is estimated based on the quantity of product transferred and an estimated price. The estimated price is based on the contractual transfer price percentage applied on the estimated weighted average net sales price per strength, which is estimated to be realized by Astellas from the end sale of roxadustat in its approved territories.
AstraZeneca Agreements
AstraZeneca U.S./Rest of World 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”).
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”), as amended and restated on August 29, 2025. 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 the Company’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue the Company receives if it licenses or sells such rights to a third-party. Neither party incurred any early termination penalties.
90
The aggregate amount of the considerations received under the AstraZeneca U.S./RoW Agreement through December 31, 2025 totals $ 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 Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”) and recorded a cumulative catch-up adjustment as described under the Drug Product Revenue, Net section below.
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 considerations received for milestone and upfront payments through the third quarter of 2025 totals $ 81.2 million . As discussed in Note 3, Discontinued Operations and Divestiture, on August 29, 2025, the Transaction was completed to sell the Company’s China operations to AstraZeneca pursuant to the Share Purchase Agreement.
AstraZeneca China Amendment
In July 2020, FibroGen China Anemia Holdings, Ltd., FibroGen Beijing, and FibroGen International (Hong Kong) Limited and AstraZeneca entered into an amendment, 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 related net product revenue recognized from 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 $ 218.6 million and $ 159.0 million for the years ended December 31, 2025 and 2024, respectively, and were included in the discontinued operations in the 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 3, Discontinued Operations and Divestiture .
Accounting for the AstraZeneca Agreements
The Company evaluated whether the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement should be accounted for as a single or separate arrangements and concluded that the agreements should be accounted for 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, and therefore upfront and other non-contingent consideration received and to be received has been pooled together and allocated to each of the performance obligations in both the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement based on their relative SSPs.
91
For each of the AstraZeneca agreements, the Company has evaluated the promised services within the respective arrangements and has identified performance obligations representing those services and bundled services that are distinct.Promised services that were not distinct have been combined with other promised services to form a distinct bundle of promised services, with revenue being recognized on the bundle of services rather than the individual promised services. There are no right-of-return provisions for the delivered items in the AstraZeneca agreements.
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 (cumulative revenue through the third quarter of 2025) that is recognized as product revenue, net, included in discontinued operations as described under China Performance Obligation section below.
For the AstraZeneca agreements, the Company allocated the transaction price to the various performance obligations based on the relative SSP of each performance obligation, with the exception of co-development billings and commercial sale of product. Co-development billings under the AstraZeneca U.S./RoW Agreement were allocated entirely to the U.S./RoW co-development services performance obligation, and co-development billings under the AstraZeneca China Agreement were allocated entirely to the combined performance obligation under the AstraZeneca China Agreement. Commercial sale of product under the AstraZeneca U.S./RoW Agreement is entirely allocated to the manufacturing commercial supply of products performance obligation, and commercial sale of product under the AstraZeneca China Agreement is allocated entirely to the combined China Performance Obligation.
In accordance with the AstraZeneca China Amendment, substantially all product sales will be made by Falikang directly to the distributors in China, while the Company continues to sell directly in one province in China. Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang. See the China Performance Obligation section below. The related net product revenue is included in the discontinued operations in the consolidated statements of operations, resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited as discussed in Note 3, Discontinued Operations and Divestiture .
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, 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, and recognized in future periods as the performance obligation is satisfied.
As discussed in Note 3, 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 third quarter of 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
December 31, 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 $ 218.6 million and $ 159.0 million for year ended December 31, 2025 and 2024, respectively, which were included in the discontinued operations in the consolidated statements of operations together with the sales directly to distributors.
92
Drug Product Revenue, Net
Drug product revenue from commercial-grade API or bulk drug product sales to Astellas and AstraZeneca was as follows for the years ended December 31, 2025 and 2024 (in thousands):
Years Ended December 31,
2025
2024
Astellas Japan Agreement
$
793
$
( 2,872
)
Astellas Europe Agreement
5,055
4,874
AstraZeneca U.S./RoW Agreement
—
25,671
Drug product revenue, net
$
5,848
$
27,673
Astellas Japan Agreement
For the year ended December 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 $ 0.8 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 bulk product strength mix intended to be manufactured by Astellas and foreign exchange impacts, among others.
For the year ended December 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 $ 2.9 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 December 31, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $ 1.6 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
During the fourth quarter of 2025, 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 $ 0.3 million as drug product revenue, and recorded $ 2.2 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, 2025, the Company reclassified $ 1.8 million from the related deferred revenue to accrued liabilities. As of December 31, 2025 , the related balance in accrued liabilities was $ 5.4 million, representing the Company’s best estimate that this amount will be paid within the next 12 months.
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 , and t he Company paid $ 7.1 million to Astellas during the year ended December 31, 2025.
The Company recognized royalty revenue of $ 4.8 million and $ 4.3 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement during the years ended December 31, 2025 and 2024, respectively. The remainder of the deferred revenue will be recognized as and when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.
93
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
Additions
Recognized as Revenue
Reclassified to Accrued Liability / Accounts Payable
Balance at
December 31, 2025
Drug product revenue - deferred revenue:
Astellas Europe Agreement
$
( 9,901
)
$
( 2,210
)
$
4,778
$
1,764
$
( 5,569
)
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 year ended December 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW Agreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $ 25.7 million to the drug product revenue and correspondingly recorded the related cost of goods sold of $ 14.6 million.
5. Consolidated Variable Interest Entity - Fortis
In May 2023 (the “Option Acquisition Date”), the Company entered into an exclusive option agreement to acquire Fortis Therapeutics (“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 the Company 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 the Company up to $ 200.0 million in contingent payments associated with the achievement of various regulatory approvals. If the Company 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 the Company chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.
Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement (together the “Fortis Agreements”), the Company has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by the Company, and manufacturing of FG-3246 option period (which ends on December 31, 2027). As part of the clinical development strategy, the Company 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 pay Fortis in support of its continued development activities, and the Company fulfilled such obligation with a last payment of $ 1.7 million in the first quarter of 2024.
Pursuant to the guidance under 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 December 31, 2025.
The transaction was accounted for as an asset acquisition under ASC 805, Business Combinations , as substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable in-process research and development (“IPR&D”) asset. The fair value of the consideration transferred was zero . The Company determined that the above mentioned quarterly payments to support Fortis’ continued development obligations should not be included in the purchase consideration, as those payments are payable to Fortis rather than to its shareholders.
Fortis has authorized and issued common shares and Series A preferred shares. The Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired prior the Option Acquisition Date and carried at zero cost. The 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 shares holders upon occurrence of certain events out of the Company’s control.
94
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.
The Company expensed fair value of the acquired IPR&D assets as research and development expense in 2023. The fair value of Fortis (enterprise value) and the fair value of nonredeemable NCI and redeemable NCI were determined based on the above-mentioned option exercise payment of $ 80.0 million and contingent payments up to $ 200.0 million, weighted with probability and expected timing of the underlying events, and discounted by the Company’s estimated market level cost of debt.
As of December 31, 2025 and 2024, total assets and liabilities of Fortis were immaterial. For the years ended December 31, 2025 and 2024 , Fortis’ net income (losses) was immaterial.
6 . Fair Value Measurements
In accordance with the authoritative guidance on fair value measurements and disclosures under U.S. GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis. The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements. The guidance also requires fair value measurements be classified and disclosed in one of the following three categories:
Level 1 : Quoted prices in active markets for identical assets or liabilities.
Level 2 : Observable inputs other than quoted prices in active markets for identical assets or liabilities.
Level 3 : Unobservable inputs.
The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs. The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2). The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability. In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S. government guarantees. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The availability of observable data is monitored to assess appropriate classification of financial instruments within the fair value hierarchy. Depending upon the availability of such inputs, specific securities may transfer between levels. In such instances, the transfer is reported at the end of the reporting period.
The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):
December 31, 2025
Level 1
Level 2
Level 3
Total
Money market funds
$
24,302
$
—
$
—
$
24,302
Corporate bonds
—
27,817
—
27,817
Commercial paper
—
17,797
—
17,797
U.S. government bonds
31,922
4,991
—
36,913
Total
$
56,224
$
50,605
$
—
$
106,829
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
95
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 years ended December 31, 2025 and 2024, the transfers of assets between levels was a total of $ 22.8 million and $ 26.3 million transfer from Level 1 to Level 2, respectively, as such US treasury notes and bills were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day.
7. Balance Sheet Components
Cash and Cash Equivalents
Cash and cash equivalents consisted of the following (in thousands):
December 31, 2025
December 31, 2024
Cash
$
2,309
$
2,004
Commercial paper
11,272
14,269
Money market funds
24,302
28,241
U.S. government bonds
9,989
5,968
Total cash and cash equivalents
$
47,872
$
50,482
Investments
As of December 31, 2025 , The Company’s investments consist primarily of available-for-sale debt investments and the amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands):
December 31, 2025
Amortized Cost
Gross Unrealized
Holding Gains
Gross Unrealized
Holding Losses
Estimated
Fair Value
Corporate bonds
$
27,800
$
17
$
—
$
27,817
Commercial paper
6,525
—
—
6,525
U.S. government bonds
26,903
21
—
26,924
Total investments
$
61,228
$
38
$
—
$
61,266
As of December 31, 2025, the available-for-sale investments had remaining contractual maturities within 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. Based on the results of its review, the Company did no t recognize any other-than-temporary impairment loss during the two years ended December 31, 2025.
The Company did no t 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):
December 31, 2025
December 31, 2024
Insurance proceeds receivable for litigation settlement
$
—
$
28,500
Holdback consideration receivable related to divestiture
4,000
—
Prepaid assets
1,015
1,903
Other current assets
1,121
1,139
Total prepaid expenses and other current assets
$
6,136
$
31,542
96
As of December 31, 2025, the Company recorded a $ 4.0 million receivable in prepaid expenses and other current assets for the second holdback related to the closing of the divestiture of FibroGen International. See Note 3, Discontinued Operations and Divestiture, for details.
As of December 31, 2024, the Company recorded a $ 28.5 million receivable in prepaid expenses and other current assets, corresponding to the accrued litigation settlement of the same amount related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit. 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):
December 31, 2025
December 31, 2024
Preclinical and clinical trial accruals
$
3,066
$
6,327
API and bulk drug product price true-up
6,977
13,071
Litigation settlement
—
28,500
Payroll and related accruals
3,983
4,640
Accrued restructuring charge
537
4,572
Professional services
2,465
2,049
Current portion of liability related to sale of future revenues
1,334
460
Other
1,821
2,416
Total accrued and other current liabilities
$
20,183
$
62,035
The accrued liabilities of $ 7.0 million and $ 13.1 million for API and bulk drug product price true-up as of December 31, 2025 and 2024, respectively, resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement. During the fourth quarter of 2025, the Company paid $ 7.1 million to Astellas related to accrued amounts. See the Drug Product Revenue, Net section in Note 4, 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 Prepaid Expenses and Other Current Assets section above, and 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 %. As a result, the Company recorded a total of $ 19.5 million non-recurring restructuring charge during the year ended December 31, 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions. Total cash payments under the reduction in force were $ 3.5 million and $ 16.5 million for the years ended December 31, 2025 and 2024, respectively. The remaining accrued restructuring charge of $ 0.5 million as of December 31, 2025 will be paid out in 2026.
8. 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 the Initial Term Loan of $ 75.0 million net of $ 0.9 million issuance costs.
97
The Initial Term Loan accrued interest at a fixed rate of 14.0 % per annum, payable monthly in arrears. The Initial Term Loan would mature on May 8, 2026 . The Initial Term Loan was subject to amortization payments. The Company was permitted to prepay the Initial Term Loan from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Initial Term Loan being repaid or prepaid, plus accrued and unpaid interest of the portion of the Initial Term Loan being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Initial Term Loan being repaid or prepaid as if such Initial Term Loan were to remain outstanding until the scheduled maturity date.
The initial issuance costs and the related transaction costs, totaling $ 3.7 million were amortized as interest expense using the effective interest method over the term of the Initial Term Loan and were reported on the balance sheet as a direct deduction from the amount of the Initial Term Loan. The effective annual interest rate of the Initial Term Loan was 16.13 % for the year ended December 31, 2025 . The Company recorded interest expense of $ 7.8 million and $ 11.7 million for the year ended December 31, 2025 and 2024, respectively, which were included in discontinued operations as the Company was required to repay the loan upon the closing of the divestiture 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 prepayment premium and fees and a $ 1.1 million amortization of issuance costs, for the year ended December 31, 2025.
The Company’s senior secured term loan facilities as of December 31, 2024 were 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
9. Liability Related to Sale of Future Revenues
In November 2022, the Company entered into a revenue interest financing agreement (the “RIFA”) with NQ Project Phoebus, L.P. (“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.
98
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.
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 15.21 % as of December 31, 2025.
The table below shows the activity of the liability related to sale of future revenues for the year ended December 31, 2025 and 2024:
For the Year Ended December 31,
2025
2024
Liability related to sale of future revenues - beginning balance
$
59,324
$
57,067
Interest paid
( 450
)
( 5,653
)
Interest expense recognized
8,440
7,910
Liability related to sale of future revenues - ending balance
67,314
59,324
Less: Current portion classified to accrued and other current liabilities
( 1,334
)
( 460
)
Liability related to sale of future revenues, non-current
$
65,980
$
58,864
During the years ended December 31, 2025 and 2024, the Company recognized, under Astellas Agreements, development revenue of $ 0.6 million and $ 1.4 million , respectively, and drug product revenue of $ 5.8 million and $ 2.0 million , respectively. See Note 4, Collaboration Agreements, License Agreement and Revenue , for details.
During the years ended December 31, 2025 and 2024 , the Company recognized the related interest expense of $ 8.4 million and $ 7.9 million, respectively. During the years ended December 31, 2025 and 2024, the Company paid $ 0.5 million and $ 5.7 million accrued interest, respectively.
Based on the current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms discussed above, the Company anticipates to reach a Payment Cap up to $ 125.0 million by 2031.
10. Product Development Obligations
The Technology Development Center of the Republic of Finland (“TEKES”) product development obligations consist of 11 separate advances (each in the form of a note agreement) received by FibroGen Europe between 1996 and 2008 from TEKES. These advances are granted on a project-by-project basis to fund various product development efforts undertaken by FibroGen Europe only. Each separate note is denominated in EUR and bears interest (not compounded) calculated as one percentage point less than the Bank of Finland rate in effect at the time of the note, but no less than 3.0 %.
If the research work funded by TEKES does not result in an economically profitable business or does not meet its technological objectives, TEKES may, on application from FibroGen Europe, forgive each of these loans, including accrued interest, either in full or in part. As of December 31, 2025 and 2024 , the Company had U.S. Dollar equivalent of $ 11.1 million and $ 9.8 million of principal outstanding, respectively, and $ 8.5 million and $ 7.2 million of interest accrued, respectively, which were presented in the product development obligations line on the consolidated balance sheets.
The Company is not a guarantor of these loans, and the principal or the accrued interest of these loans are not repayable by FibroGen Europe until it has distributable funds.
99
11. Commitments and Contingencies
Contract Obligations
As of December 31, 2025, the Company had outstanding total non-cancelable purchase obligations of $ 3.3 million for general purchases and other programs and $ 2.3 million for manufacture and supply of roxadustat, expected to pay within the next twelve months. The Company expects to fulfill its commitments under these agreements in the normal course of business, and as such, no liability has been recorded.
See Note 9, Liability Related to Sale of Future Revenues and Note 10, Product Development Obligations for details of the respective 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 consolidated balance sheet as of December 31, 2025.
Between April 2021 and May 2021, five putative securities class action complaints were filed against the Company 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 U.S. Securities and Exchange Commission (“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 and the Company has been making payments to the agreed upon payment schedule.
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 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.
There is currently one SEC complaint against the Company's former Chief Medical Officer in U.S. District Court. While the Company is not a party to this proceeding, pursuant to its indemnification agreement with the former officer, the Company is obligated to advance certain legal expenses and may be required to indemnify certain costs and judgments; however, certain judgments, settlements, or fines sought by the SEC would not be covered by the Company under the indemnification agreement.
100
As of December 31, 2025, the Company’s accrued liabilities related to these obligations were not material. The Company is unable to reasonably estimate the total amount of future indemnification costs beyond amounts currently accrued due to the early stage of the litigation and significant uncertainties regarding the duration, scope, and outcome of the proceedings.
12. Equity and Stock-based Compensation
Common Stock
On June 16, 2025, the Company effected the Reverse Stock Split. 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. Each share of Common Stock is entitled to one vote . The holders of Common Stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding.
Shares of Common Stock outstanding, shares of stock plans outstanding and shares reserved for future issuance related to stock options and RSU grants and the Company’s Employee Stock Purchase Plan (“ESPP”) purchases are as follows (in thousands):
December 31,
2025
2024
Common stock outstanding
4,047
4,037
Stock options outstanding
373
389
RSUs outstanding
16
53
Shares reserved for future stock options and RSUs grant
818
776
Shares reserved for future ESPP offering
265
265
Total shares of common stock reserved
5,519
5,520
At-the-Market Program
On February 24, 2025, the Company entered into an Equity Distribution Agreement with BofA Securities, Inc. (“BofA”), under which it may offer and sell its common stock having aggregate sales proceeds of up to $ 30.0 million from time to time through BofA as its sales agent. The Company did no t sell any shares of common stock under this ATM program during the years ended December 31, 2025.
Stock Plans
Stock Option and RSU Plans
In September 2014, the Company adopted a 2014 Equity Incentive Plan (the “2014 Plan”) which became effective in November 2014. The 2014 Plan is the successor equity compensation plan to the 2005 Plan. The 2014 Plan provided for the grant of incentive stock options, nonqualified stock options, restricted stock awards, stock appreciation rights, performance stock awards, performance cash awards, restricted stock units and other stock awards to employees, directors and consultants. Stock options granted must be at prices not less than 100 % of the fair market value at date of grant. Option vesting schedules were determined by the Company at the time of issuance and generally have a four year vesting schedule. Options generally expire ten years from the date of grant . Unvested options exercised are subject to the Company’s repurchase right.
In June 2024, the Company’s 2024 Equity Incentive Plan (the “2024 Plan”), the successor to and continuation of the 2014 Plan, became effective. The 2024 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance stock awards to employees, directors and consultants. Stock options granted must be at prices not less than 100 % of the fair market value at date of grant. Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule. Options generally expire ten years from the date of grant. Unvested options exercised are subject to the Company’s repurchase right. As of December 31, 2025 , the Company has reserved 823,929 shares of its common stock that remains unissued for issuance under the 2024 Plan.
Issuance of shares upon share option exercise or share unit conversion is made through issuance of new shares authorized under the plan.
101
Certain Common Stock option holders have the right to exercise unvested options, subject to a right held by the Company to repurchase the stock, at the original exercise price, in the event of voluntary or involuntary termination of employment of the stockholder. The shares are generally released from repurchase provisions ratably over four years. The Company accounts for the cash received in consideration for the early exercised options as a liability. At December 31, 2025 and 2024 , no shares of Common Stock were subject to repurchase by the Company.
In Fe bruary 2023, the Company granted 6,366 total shares of PRSUs to certain executives for the performance period beginning January 1, 2023 and ending December 31, 2026. In Fe bruary 2022, the Company granted 11,218 total shares of PRSUs to certain executives for the performance period beginning January 1, 2022 and ending December 31, 2025. The ultimate number of shares eligible to vest for PRSUs range from 0 % to 200 % of the target number of shares depending on achievement relative to the predefined clinical performance metrics and continued employment with the Company. During the year ended December 31, 2025 , 93 shares of the PRSUs have vested and been released.
In Fe bruary 2023, the Company granted 6,366 total shares of TSR awards to certain executives for the performance period beginning January 1, 2023 and ending December 31, 2026. In Fe bruary 2022, the Company granted 11,218 total shares of TSR awards to certain executives for the performance period beginning January 1, 2022 and ending December 31, 2025. The ultimate number of shares eligible to vest for the TSR awards range from 0 % to 200 % of the target number of shares depending on the TSR of the Company’s common stock as compared to companies in the NBI index, and continued employment with the Company. During the year ended December 31, 2025 , no TSR awards shares have vested and been released.
Stock option transactions, including forfeited options granted under the 2024 Plan as well as prior plans, are summarized below:
Shares
(In thousands)
Weighted
Average
Exercise Price per
Share
Weighted
Average
Remaining Contractual
Life
(In Years)
Aggregate
Intrinsic Value
(In thousands)
Outstanding at December 31, 2024
389
$
400.52
Granted
263
15.14
Forfeited
( 82
)
59.65
Expired
( 197
)
577.45
Outstanding at December 31, 2025
373
110.26
8.23
$
30
Vested and expected to vest, December 31, 2025
329
122.04
8.15
28
Exercisable at December 31, 2025
146
$
240.24
7.33
$
12
The estimated weighted-average fair value of the stock options granted during the years ended December 31, 2025 and 2024 was $ 15.14 and $ 43.43 , respectively. There was no option exercised during the years ended December 31, 2025 and 2024.
The following table summarizes the activities of RSUs, PRSUs and TSR awards:
Shares
(In thousands)
Weighted Average Fair Value at Grant
Unvested at December 31, 2024
53
$
235.21
Granted
—
—
Vested
( 18
)
205.80
Forfeited
( 19
)
289.51
Unvested at December 31, 2025
16
$
201.50
Among the vested RSUs during the year ended December 31, 2025 , 10,204 shares were released and issued, while the remaining was withheld for the related payroll taxes. There was no awards granted during the year ended December 31, 2025. The estimated weighted-average fair value of the awards granted during the years ended December 31, 202 4 was $ 44.47 .
102
ESPP
In September 2014, the Company adopted a 2014 ESPP that became effective in November 2014. The 2014 ESPP is designed to enable eligible employees to periodically purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15 % of their eligible compensation, subject to any plan or IRS limitations. At the end of each offering period, employees are able to purchase shares at 85 % of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last day of the offering period. Purchases are accomplished through participation in discrete offering periods. The 2014 ESPP is intended to qualify as an ESPP under Section 423 of the Internal Revenue Code. The Company has reserved 64,000 shares of its common stock for issuance under the 2014 ESPP. There were 14,163 shares purchased by employees under the 2014 ESPP during the years ended December 31, 202 4. The 2014 ESPP was suspended as of December 31, 2024.
Stock-Based Compensation
Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense for the years the years ended December 31, 2025 and 2024 was as follows (in thousands):
Years Ended December 31,
2025
2024
Research and development
$
2,322
$
12,064
Selling, general and administrative
4,023
11,381
Total stock-based compensation expense
$
6,345
$
23,445
The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options and RSUs is being amortized on a straight-line basis over the requisite service period of the awards. Compensation cost for PRSUs is expensed over the respective vesting periods when the achievement of performance criteria is probable. The Company estimates the fair value of the TSR awards using the Monte Carlo valuation model to simulate the probabilities of achievement. Compensation cost for the TSR awards is recognized over the requisite service period, regardless of when, if ever, the market condition is satisfied. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the Nasdaq Global Select Market on the date of the grant.
The fair value of employee stock-based compensation is estimated using the following assumptions:
• Expected Term. Expressed as a weighted-average, the expected life of the options is based on the average period the stock options are expected to be outstanding and was based on the Company’s historical information of the option exercise patterns and post-vesting termination behavior as well as contractual terms of the instruments. The expected term of 2014 ESPP shares is the average of the remaining purchase periods under each offering period. The expected term of TSR awards is determined based on the grant date to the end of the performance period.
• Expected Volatility. The Company considers its historical volatility data for volatility considerations for all of its stock-based compensation types except for its TSR awards, which is based on a blend of the Company’s and comparable public entities’ historical volatility.
• Risk-Free Interest Rate. Expressed as a weighted-average, the risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s respective stock-based compensation types.
• Expected Dividend Yield. The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future.
103
The assumptions used to estimate the fair value of stock options granted and ESPPs using the Black-Scholes option valuation model were as follows:
Years Ended December 31,
2025
2024
Stock Options
Expected term (in years)
5.4
6.1
Expected volatility
123.8
%
113.7
%
Risk-free interest rate
4.3
%
4.2
%
Expected dividend yield
—
—
Weighted average estimated fair value
$
13.23
$
1.49
ESPPs
Expected term (in years)
—
0.5 - 2.0
Expected volatility
—
%
61.5 - 271.2
%
Risk-free interest rate
—
%
2.6 - 5.3
%
Expected dividend yield
—
—
Weighted average estimated fair value
$
—
$
1.67
The assumptions used to estimate the fair value of the TSR awards using the Monte Carlo valuation model were as follows:
Year Ended December 31,
2025
2024
TSR awards
Expected term (in years)
3.9
3.9
Expected volatility
69.0 - 73.3
%
69.0 - 73.3
%
Risk-free interest rate
1.8 - 4.2
%
1.8 - 4.2
%
Expected dividend yield
—
—
Weighted average estimated fair value
$
759.23
$
737.88
As of December 31, 2025 , there was $ 3.6 million of total unrecognized compensation costs, net of estimated forfeitures, related to non-vested stock option awards granted that will be recognized on a straight-line basis over the weighted-average period of 2.50 years. As of December 31, 2025 , there was $ 1.7 million of total unrecognized compensation costs, net of estimated forfeitures, related to non-vested RSUs, PRSUs and TSR awards granted that will be recognized on a straight-line basis over the weighted-average period of 1.73 years.
Subsidiary Stock and Non-Controlling Interests
FibroGen Europe
FibroGen Europe has a total of 42,619,022 shares of Preferred Stock outstanding, of which there are 1,700,845 shares of Series A Preferred Stock, 1,875,000 shares of Series B Preferred Stock, 1,599,503 shares of Series C Preferred Stock, 1,520,141 shares of Series D Preferred Stock, 459,565 shares of Series E Preferred Stock, 5,714,332 shares of Series F Preferred Stock, 9,927,500 shares of Series G Preferred Stock and 19,822,136 shares of Series H Preferred Stock, all of which shares no longer have any right to be exchanged for the Company’s Common Stock. Of all the Preferred Stock outstanding, a total of 37,184,807 shares are owned by Kyntra Bio and 5,434,215 shares are owned by minority shareholders. In addition, FibroGen Europe has 7,800,000 common shares outstanding owned by Kyntra Bio. The holders of FibroGen Europe’s shares of Preferred Stock (“Preferred Shares”) have the following rights, preferences and privileges:
Dividend Rights — When the assets of FibroGen Europe are distributed (except for distribution in a liquidation), Preferred Shares shall have the same rights to dividend or other forms of distribution as shares of Common Stock of FibroGen Europe. In the event of a merger, holders of Preferred Shares do not have the right to demand FibroGen Europe to redeem all or part of their Preferred Shares. FibroGen Europe may repurchase shares of Common Stock or Preferred Shares for consideration.
Pre-emptive Right — Preferred Shares shall have pre-emptive subscription right in accordance with the Finnish Limited Liability Companies Act if additional shares are issued, option rights are given, or convertible loan is taken, provided , however , that the foregoing pre-emptive right does not apply to a directed share issue, for which two thirds (2/3) of the voting shares represented at a general meeting of shareholders approve for an important legitimate cause.
104
Redemption Right — If a Preferred Share can be redeemed by a majority shareholder owning more than ninety percent ( 90 %) of the shares of FibroGen Europe in accordance with the provisions of the Finnish Limited Liability Companies Act, the minority holders of Preferred Shares have the right to request redemption of their shares.
Voting Right — Each share has one vote . Preferred Shares have voting rights only in situations that are specifically provided in the Articles of Association, which include a merger transaction and directed share issue. In addition, Preferred Shares have right to vote in a general shareholder meeting for amending the Articles of Association if the amendment will affect the rights of Preferred Shares.
Conversion Right (1-for- 1 basis into Common Stock of FibroGen Europe):
• Voluntary conversion right: Preferred Shares can be converted into common shares upon the written request of a shareholder provided that the conversion is feasible within the maximum and minimum amounts of shares of classes of FibroGen Europe as set forth in its Articles of Association. Such request can be withdrawn before the notification of conversion is filed with the Finnish Trade Register.
• Compulsory conversion right: Preferred Shares will be converted into common shares if (i) FibroGen Europe’s shares are listed in a stock exchange or other trading system in the European Economic Area, or (ii) FibroGen Europe’s recombinant collagen and gelatin production technology is being put into commercial use in the area of Europe and certain other European states. Commercial use means there is income generated from the first commercial sale of the products incorporating the above-mentioned technology and does not include license fees, development financing, milestone payments or income from test products or equipment used in research. The board of directors of FibroGen Europe shall notify the shareholders of the compulsory conversion in writing, and the shareholders shall request to convert their shares within the timeframe provided in the notification. Should the shareholders fail to make the conversion request within the time limit, FibroGen Europe may redeem the shares of such shareholders.
Liquidation Right — In the event of a dissolution of FibroGen Europe, holders of Preferred Shares are entitled to be paid in an amount equal to the subscription price of the shares before any distribution is made to holders of common shares. Among holders of Preferred Shares, holders of shares of Series F Preferred Stock are entitled to be paid in an amount equal to the subscription price of Series F Preferred Stock before any distribution is made to holders of other Preferred Shares.
Non-controlling interest positions related to the issuance of FibroGen Europe’s stock are reported as a separate component of consolidated equity from the equity attributable to the Company’s stockholders. In addition, the Company does not allocate losses to the non-controlling interests as the outstanding shares representing the non-controlling interest do not represent a residual equity interest in FibroGen Europe.
FibroGen Cayman
FibroGen Cayman has 15,836,966 Series A Preference Shares outstanding, including 10,484,260 shares owned by Kyntra Bio. and 5,352,706 shares owned by minority shareholders, and 78,000,000 common shares outstanding owned by Kyntra Bio. The holders of the FibroGen Cayman Series A Preference Shares have the following rights, preferences and privileges:
Liquidation — 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”), i.e. the product of the number of shares held by a holder of shares of FibroGen Cayman Series A Preference Shares and the original issue price of $ 1.00 (subject to equitable adjustment for any stock dividend, combination, split, reclassification, recapitalization) plus all declared and unpaid dividends thereon.
Conversion — Each share of FibroGen Cayman Series A Preference Shares is convertible into the number of fully paid and non-assessable shares of Common Stock of FibroGen Cayman that results from dividing the original issue price by the conversion price in effect at the time of the conversion, subject to adjustments for stock splits, stock dividends, reclassifications and like events. The FibroGen Cayman Series A Preference Shares have a conversion price that is equal to the original issuance price such that the conversion ratio to FibroGen Cayman Common Stock is 1: 1 as of all periods presented.
Voting — The holders of FibroGen Cayman Series A Preference Shares are entitled to vote together with the FibroGen Cayman Common Stockholders on all matters submitted for a vote of the stockholders. The holder of each share of FibroGen Cayman Series A Preference Shares has the number of votes equal to the number of shares of FibroGen Cayman Common Stock into which it is convertible.
105
Dividends — The holders of FibroGen Cayman Series A Preference Shares are entitled to receive cash dividends when and if declared, at a rate of 6 %.
The discontinued operations sold under the Transaction discussed in the above Note 3, 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 year ended December 31, 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.
13. Net 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 years ended December 31, 2025 and 2024. Therefore, dilutive common shares are not assumed to have been issued since their effect is anti-dilutive for these periods.
Diluted weighted average shares excluded the following potential common shares related to stock options, RSUs, PRSUs, 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):
Years Ended December 31,
2025
2024
Employee stock options
465
538
RSUs, PRSUs and TSR awards
33
125
ESPP
—
18
498
681
14. Income Taxes
The components of loss before income taxes are as follows (in thousands):
Years Ended December 31,
2025
2024
Domestic
$
( 47,917
)
$
( 142,819
)
Foreign
( 10,377
)
( 10,548
)
Loss before benefit for income taxes
$
( 58,294
)
$
( 153,367
)
106
The benefit for income taxes consists of the following (in thousands):
Years Ended December 31,
2025
2024
Current:
Federal
$
—
$
—
State
—
—
Foreign
( 90
)
( 269
)
Total current
( 90
)
( 269
)
Deferred:
Federal
—
—
State
—
—
Foreign
—
—
Total deferred
—
—
Benefit from income taxes
$
( 90
)
$
( 269
)
A reconciliation of the benefit for income taxes to the amount computed by applying the 21 % statutory U.S. federal income tax rate to income before income taxes for the year ended December 31, 2025, after the adoption of ASU 2023-09, is as follows:
Years Ended December 31, 2025
Amount
%
Tax at statutory federal rate
$
( 12,242
)
21.0
%
State tax, net of federal benefit
—
—
%
Foreign Tax Effects
Foreign Rate Differential – Cayman Islands
2,110
( 3.6
)%
Foreign Rate Differential – Finland
76
( 0.1
)%
Effect of cross-border tax laws
Global intangible low-taxed income
62,730
( 107.6
)%
Other
( 90
)
0.2
%
Tax credits
578
( 1.0
)%
Change in valuation allowance
( 59,391
)
101.9
%
Worldwide changes in unrecognized tax benefits
( 180
)
0.3
%
Nondeductible items
Stock based compensation
5,591
( 9.6
)%
Disallowed interest
448
( 0.8
)%
Other
9
—
%
Other
271
( 0.5
)%
Total
$
( 90
)
0.2
%
The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate for year ended in December 31, 2024, prior to the adoption of ASU 2023-09, is as follows:
Years Ended December 31,
2024
Tax at statutory federal rate
21.0
%
State tax
—
%
Stock-based compensation expense
( 3.2
)%
Net operating losses not benefitted
( 13.9
)%
Foreign net operating losses not benefitted
( 1.4
)%
Deduction limitation on executive compensation
—
%
Global intangible low-taxed income
( 2.1
)%
Other
( 0.2
)%
Total
0.2
%
107
Significant components of the Company’s deferred tax assets are as follows (in thousands):
December 31,
2025
2024
Federal and state net operating loss carryforwards
$
173,195
$
206,365
Tax credit carryforwards
128,924
129,320
Foreign net operating loss carryforwards
112
120
Capitalized research and development expenses
64,293
83,329
Stock-based compensation
2,128
6,365
Lease obligations
12
22
Reserves and accruals
4,760
4,418
Deferred revenue
—
7,785
Intangible assets
14,135
15,036
Other
6
—
Subtotal
387,565
452,760
Less: Valuation allowance
( 387,555
)
( 452,740
)
Net deferred tax assets
10
20
Fixed assets
( 10
)
( 20
)
Non-deductible accrued expenses
—
—
Net deferred tax liabilities
( 10
)
( 20
)
Total net deferred tax assets
$
—
$
—
A valuation allowance has been provided to reduce the deferred tax assets to an amount management believes is more likely than not to be realized. Expected realization of the deferred tax assets for which a valuation allowance has not been recognized is based on upon the reversal of existing temporary differences and future taxable income.
The valuation allowance decreased by $ 65.2 million for the year ended December 31, 2025 and increased by $ 26.4 million for the years ended December 31, 2024. Due to uncertainty surrounding the realization of the favorable tax attributes in the future tax returns, the Company has established a valuation allowance against its otherwise recognizable net deferred tax assets.
The Company intends to continue maintaining a full valuation allowance on its deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this allowance.
At December 31, 2025 , the Company had net operating loss carryforwards available to offset future taxable income of approximately $ 787.4 million and $ 145.4 million for federal and state tax purposes, respectively. $ 140.5 million of the federal net operating loss carryforwards will begin to expire in 2035 if not utilized, while the remainder can be carried forward indefinitely. The state net operating loss carryforward will begin to expire in 2031 if not utilized. The Company also had foreign net operating loss carryforwards of approximately $ 0.6 million, which expire between 2026 and 2034 if not utilized.
At December 31, 2025 , the Company had approximately $ 153.8 million of federal and $ 53.7 million of California research and development tax credit and other tax credit carryforwards available to offset future taxable income. The federal credits begin to expire in 2026 and the California research credits have no expiration dates.
Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership change” for tax purposes, as defined in Internal Revenue Code (“IRC”) Section 382. The Company performed an IRC Section 382 analysis and has determined that there were no ownership changes as of December 31, 2024. Thus, IRC Section 382 will not limit the use of the Company’s net operating loss and tax credit carryforwards. The Company will continue to monitor trading activities in its shares which could cause ownership change in future years.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act, including restoring 100 % bonus depreciation, eliminating the capitalization requirement for domestic research and experimentation, and changing the business interest expense limitation. ASC 740 requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation was enacted in the third quarter of 2025. The provisions do not have a material impact on the Company’s financial statements.
108
Uncertain Tax Positions
The Company had unrecognized tax benefits of approximately $ 74.5 million as of December 31, 2025 . Approximately $ 0.4 million of unrecognized tax benefits, if recognized, would affect the effective tax rate. The interest accrued as of December 31, 2025 and 2024 was immaterial.
A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the two years ended December 31, 2025 is as follows (in thousands):
Federal and State
Balance as of December 31, 2023
$
70,710
Decrease due to prior positions
( 156
)
Increase due to current year position
3,920
Foreign exchange rate differential
( 153
)
Balance as of December 31, 2024
74,321
Decrease due to prior positions
( 229
)
Increase due to current year position
372
Foreign exchange rate differential
—
Balance as of December 31, 2025
$
74,464
Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business.
The Company classifies interest and penalties as a component of tax expense, if any.
The Company files income tax returns in the U.S. federal jurisdiction, U.S. state and other foreign jurisdictions. The U.S. federal and U.S. state taxing authorities may choose to audit tax returns for tax years beyond the statute of limitation period due to significant tax attribute carryforwards from prior years, making adjustments only to carryforward attributes. The foreign statute of limitation generally remains open from 2015 to 2025 . The Company is not currently under audit in any tax jurisdiction. The Company did no t have any cash payment for income taxes for the years ended December 31, 2025 and 2024.
15. Segment and Geographic 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 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 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.
Supplemental enterprise-wide information is presented below.
Geographic Revenues
Geographic revenues, which are based on the region that revenue is generated, are as follows (in thousands):
Years Ended December 31,
2025
2024
United States
$
—
$
26,114
Europe
5,643
6,270
Japan
797
( 2,854
)
China
—
91
Total revenue
$
6,440
$
29,621
109
Customer Concentration
The Company’s revenues have been generated from the following collaboration partners that individually accounted for 10% or more of the Company’s total revenue:
Percentage of Revenue
Years Ended December 31,
2025
2024
AstraZeneca
—
%
88
%
Astellas
100
%
12
%
110
Schedule II: Valuation an d Qualifying Accounts
(in thousands)
Charged
Charged
to Other
Balance at
(Credited)
Accounts -
Beginning of
to Statement
Liabilities
Deductions,
Balance at
Year
of Operation
and Equity
Net
End of Year
Valuation allowances for deferred tax assets
Year ended December 31, 2025
$
452,740
$
( 65,185
)
$
—
$
—
$
387,555
Year ended December 31, 2024
$
426,355
$
26,385
$
—
$
—
$
452,740
111
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOU NTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROL S AND PROCEDURES
Attached as Exhibits 31.1 and 31.2 to this Annual Report on Form 10-K for the year ended December 31, 2025 (“Annual Report”) are certifications of our Chief Executive Officer and our Chief Financial Officer required by Rule 13a-14(a) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Rule 13a-14(a) and 15d-15(e) Certifications”). This Controls and Procedures section of the Annual Report includes the information concerning the controls evaluation referred to in the Rule 13a-14(a) and 15d-15(e) Certifications.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2025, the end of the period covered by this Annual Report. Disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) are designed to provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to the company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Based on our evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2025.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) of the Exchange Act. Our internal control over financial reporting is a process established under the supervision of and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management, with the participation and under the supervision of our Chief Executive Officer and our Chief Financial Officer, evaluated our internal control over financial reporting as of December 31, 2025, the end of our fiscal year, using the criteria established in Internal Control - Integrated Framework (2013) set forth by the Committee of Sponsoring Organizations of the Treadway Commission.
Based on our evaluation, our management has concluded that our internal control over financial reporting was effective as of December 31, 2025 to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
This report does not include an attestation report of our registered public accounting firm as we are a non-accelerated filer and a smaller reporting company.
Limitations on the Effectiveness of Controls
In designing and evaluating the disclosure controls and procedures, management recognizes that because of the inherent limitations in all control systems, any controls and procedures, no matter how well designed and operated, can provide only reasonable not absolute, assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and the benefits of controls and procedures must be considered relative to their costs.
112
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the fiscal quarter ended December 31, 2025 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
We are implementing an enterprise resource planning (“ERP”) system, which will replace our existing operating and financial systems in the U.S. in the first quarter of 2026. While we expect the ERP implementation to improve the efficiency of certain financial and transactional processes, the related changes will materially affect our internal control over financial reporting beginning in the first quarter of 2026, and we have been monitoring such changes during the implementation process.
ITEM 9B. OTHER INFORMATION
Trading Arrangements
None .
Ite m 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
113
PART III
ITEM 10. DIRECTORS, EXECUTIVE OF FICERS AND CORPORATE GOVERNANCE
The information required by this item relating to our directors and nominees, including information with respect to our audit committee, audit committee financial experts and procedures by which stockholders may recommend nominees to our Board of Directors, is incorporated by reference to the sections titled “Proposal 1 – Election of Directors” and “Directors and Corporate Governance” in our Proxy Statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2025 (the “2026 Proxy Statement”). The information required by this item regarding our executive officers is incorporated by reference to the section titled “Executive Officers” appearing in our 2026 Proxy Statement. The information, if any, required by this item regarding compliance with Section 16(a) of the Securities Exchange Act of 1934, as amended, is incorporated by reference to the section titled “Delinquent Section 16(a) Reports” appearing in our 2026 Proxy Statement.
Insider Trading Policy
We have adopted an Insider Trading Policy governing the purchase, sale and/or other dispositions of our securities by our directors, officers and employees. A copy of the Insider Trading Policy is filed as an exhibit to this Annual Report on Form 10-K. In addition, it is our practice to comply with the applicable laws and regulations relating to insider trading.
Code of Conduct
We have adopted a Code of Business Conduct and Ethics that applies to all of our directors, officers and employees. A copy of our Code of Business Conduct and Ethics can be found on our website (www.kyntrabio .com ) under “Corporate Governance.” The contents of our website are not a part of this Annual Report.
In addition, we intend to promptly disclose the nature of any amendment to, or waiver from, our Code of Business Conduct that applies to our principal executive officer, principal financial officer, principal accounting officer or persons performing similar functions on our website in the future.
ITEM 11. EXECUTI VE COMPENSATION
The information required by this item is incorporated by reference to the sections titled “Executive Compensation,” “Director Compensation,” and “Compensation Committee Interlocks and Insider Participation” appearing in our 2026 Proxy Statement.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OW NERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is incorporated by reference to the sections titled “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” appearing in our 2026 Proxy Statement.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated by reference to the sections titled “Transactions with Related Persons” and “Directors and Corporate Governance” appearing in our 2026 Proxy Statement.
ITEM 14. PRINCIPAL ACCOU NTANT FEES AND SERVICES
The information required by this item is incorporated by reference to the proposal titled “Proposal 3 - Ratification of Selection of Independent Registered Public Accounting Firm” appearing in our 2026 Proxy Statement.
114
PART IV
ITEM 15. EXHIBITS AND FINA NCIAL STATEMENT SCHEDULES
(a) We have filed the following documents as part of this Annual Report:
1. Consolidated Financial Statements
Information in response to this Item is included in Part II, Item 8 of this Annual Report.
2. Financial Statement Schedules
Schedule II is included on page 111 . All other schedules are omitted because they are not required or the required information is included in the consolidated financial statements or notes thereto.
3. Exhibits
See Item 15(b) below.
(b) Exhibits —We have filed, or incorporated into this Annual Report by reference, the exhibits listed below. Where an exhibit is incorporated by reference, the number in parentheses indicates the document to which cross-reference is made. Refer to the end of this table for a listing of cross-reference documents.
Exhibit
Incorporation By Reference
Number
Exhibit Description
Form
SEC File No.
Exhibit
Filing Date
3.1
Amended and Restated Certificate of Incorporation.
8-K
001-36740
3.1
11/21/2014
3.2
Amended and Restated Bylaws.
8-K
001-36740
3.1
04/04/2025
3.3
First Amendment to Amended and Restated Bylaws.
8-K
001-36740
3.2
01/07/2026
3.4
Certificate of Amendment of the Amended and Restated Certificate of Incorporation.
8-K
001-36740
3.1
06/12/2025
3.5
Certificate of Amendment of the Amended and Restated Certificate of Incorporation.
8-K
001-36740
3.1
01/07/2026
4.1
Form of Common Stock Certificate.
8-K
001-36740
4.1
11/21/2014
4.2
Shareholders’ Agreement by and among FibroGen International (Cayman) Limited and certain of its shareholders, dated as of September 8, 2017.
10-Q
001-36740
4.6
11/8/2017
4.4
Description of Capital Stock .
10-K
001-36740
4.4
3/2/2020
10.1+*
2024 Equity Incentive Plan .
—
—
—
—
10.1(ii)+*
Form of Restricted Stock Unit Grant Notice and Award Agreement (2024 Equity Incentive Plan) .
—
—
—
—
115
10.1(iii)+*
Form of Stock Option Grant Notice and Option Agreement (2024 Equity Incentive Plan) .
—
—
—
—
10.2+*
2014 Equity Incentive Plan and forms of agreement thereunder .
—
—
—
—
10.3+*
2014 Employee Stock Purchase Plan .
—
—
—
—
10.4+
Non-Employee Director Compensation Policy, as amended, dated April 22, 2024.
10-Q
001-36740
10.3
5/6/2024
10.5+*
Bonus Plan .
—
—
—
—
10.6+*
Form of Employment Offer Letter .
—
—
—
—
10.7
Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of June 1, 2005.
10-Q
001-36740
10.1
11/5/2020
10.8
Amendment No. 1 to Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of January 1, 2013.
10-K
001-36740
10.9(i)
2/27/2019
10.9
Amendment No.2 to Collaboration Agreement, by and between Astellas Pharma, Inc. and FibroGen, Inc., dated June 6, 2025.
10-Q
001-36740
10.1
8/11/2025
10.10
Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of April 28, 2006.
S-1
333-199069
10.12
10/1/2014
10.11
Amendment to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of August 31, 2006.
S-1
333-199069
10.13
10/1/2014
10.12
Amendment No. 2 to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of December 1, 2006.
S-1
333-199069
10.14
10/1/2014
10.13
Supplement to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., effective as of April 28, 2006.
S-1
333-199069
10.15
10/1/2014
116
10.14
Amendment No. 3 to Anemia License and Collaboration Agreement, by and between FibroGen, Inc. and Astellas Pharma Inc., dated as of May 10, 2012.
S-1
333-199069
10.16
10/1/2014
10.15+*
Form of Indemnity Agreement by and between Kyntra Bio, Inc. and its directors and officers .
—
—
—
—
10.16
Commercial Supply Agreement by and between FibroGen, Inc. and Catalent Pharma Solutions, LLC, effective as of January 1, 2020 .
10-K
001-36740
10.28
3/2/2020
10.17
Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd. and STA Pharmaceutical Hong Kong Limited, effective March 2, 2020 .
8-K
001-36740
99.1
3/24/2020
10.18
Amendment No.1 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd. and STA Pharmaceutical Hong Kong Limited, effective May 11, 2020 .
10-Q
001-36740
10.2
8/6/2020
10.19
Amendment No. 2 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd. and STA Pharmaceutical Hong Kong Limited, effective July 24, 2020 .
10-Q
001-36740
10.8
11/5/2020
10.20
Astellas EU Supply Agreement by and between FibroGen, Inc. and Astellas Pharma Europe Ltd, effective as of January 1, 2021.
10-Q
001-36740
10.2
5/10/2021
10.21
Amendment No. 3 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd., and STA Pharmaceutical Hong Kong Limited, dated as of January 12, 2021.
10-Q
001-36740
10.3
5/10/2021
10.22
Amendment No. 4 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd., and STA Pharmaceutical Hong Kong Limited, dated as of October 29, 2021.
10-K
001-36740
10.36
2/28/2022
10.23+*
Form of Executive Officer Change in Control and Severance Agreement .
—
—
—
—
117
10.24
ATM Equity Offering Sales Agreement, by and between FibroGen, Inc. and BofA Securities, Inc., dated as of February 24, 2025.
8-K
001-36740
1.1
2/24/2025
10.25
Revenue Interest Financing Agreement by and between FibroGen, Inc. and NQ Project Phoebus, L.P., dated as of November 4, 2022.
10-K
001-36740
10.46
2/27/2023
10.26
Letter Agreement by and among Astellas Pharma Inc., Astellas Pharma Europe Ltd., and FibroGen, Inc., effective as of November 4, 2022.
10-K
001-36740
10.47
2/27/2023
10.27
Amendment No.1 to Commercial Supply Agreement (Roxadustat) by and between FibroGen, Inc. and its Affiliates and Catalent Pharma Solutions, LLC, effective as of January 1, 2023.
10-Q
001-36740
10.2
5/8/2023
10.28+
Offer Letter, dated July 23, 2023, between FibroGen, Inc. and Thane Wettig.
8-K
001-36740
10.1
7/25/2023
10.29
First Amended and Restated Evaluation Agreement by and between FibroGen, Inc. and Fortis Therapeutics, Inc., dated June 6, 2024.
10-Q
001-36740
10.2
8/6/2024
10.30
First Amended and Restated Option Agreement and Plan of Merger by and among FibroGen, Inc., Fortis Therapeutics, Inc., and Shareholder Representative Services LLC, dated June 6, 2024.
10-Q
001-36740
10.3
8/6/2024
10.31
Amendment No.1 to the First Amended and Restated Evaluation Agreement, by and between Fortis Therapeutics and FibroGen, Inc., dated as of March 28, 2025.
10-Q
001-36740
10.2
5/12/2025
10.32
Amendment No.1 to the First Amended and Restated Option Agreement and Plan of Merger, by and between Fortis Therapeutics and FibroGen, Inc., dated as of March 28, 2025.
10-Q
001-36740
10.3
5/12/2025
118
10.33
Termination Agreement by and between FibroGen, Inc. and AstraZeneca AB, effective as of February 25, 2024, as amended and restated on August 29, 2025.
10-Q
001-36740
10.2
11/10/2025
10.34
Share Purchase Agreement by and among AstraZeneca Treasury Limited, FibroGen China Anemia Holdings, Ltd., and FibroGen, Inc., dated as of February 20, 2025.
10-Q
001-36740
10.1
5/12/2025
10.35
Amendment to Share Purchase Agreement, by and among AstraZeneca Treasury Limited, FibroGen China Anemia Holdings, Ltd., and FibroGen, Inc., dated as of August 29, 2025.
10-Q
001-36740
10.3
11/10/2025
19*
Insider Trading and Trading Window Policy .
—
—
—
—
21.1*
Subsidiaries of Kyntra Bio, Inc.
—
—
—
—
23.1*
Consent of PricewaterhouseCoopers LLP.
—
—
—
—
24.1*
Power of Attorney (included in signature pages).
—
—
—
—
31.1*
Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a).
—
—
—
—
31.2*
Certification of Chief Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a).
—
—
—
—
32.1**
Certification of Principal Executive Officer and Principal Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350)(1).
—
—
—
—
97.1*
Policy for Recoupment of Incentive Compensation .
—
—
—
—
101.INS*
Inline XBRL Instance Document: the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
—
—
—
—
119
101.SCH*
Inline XBRL Taxonomy Schema Linkbase Document
—
—
—
—
104
Cover Page Interactive Data File (embedded within the inline XBRL document)
—
—
—
—
* Filed herewith.
** Furnished herewith.
Portions of this exhibit (indicated by asterisks) have been omitted as the Company has determined that (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm if publicly disclosed or is the type of information the Company treats as confidential.
+ Indicates a management contract or compensatory plan.
(1) This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Kyntra Bio, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.
(c) Financial Statement Schedules —See (a) 2 above. All other financial statement schedules are omitted because they are not applicable because the requested information is included in the consolidated financial statements or notes thereto.
ITEM 16. FOR M 10-K SUMMARY
None.
120
SIGNA TURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Francisco, State of California.
KYNTRA BIO, INC.
Date: March 16, 2026
By:
/s/ Thane Wettig
Thane Wettig
Chief Executive Officer
(Principal Executive Officer)
Date: March 16, 2026
By:
/s/ David DeLucia
David DeLucia
Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
121
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Thane Wettig and David DeLucia, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Thane Wettig
Chief Executive Officer
(Principal Executive Officer)
March 16, 2026
Thane Wettig
/s/ David DeLucia
Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
March 16, 2026
David DeLucia
/s/ James A. Schoeneck
Chairman of the Board and Director
March 16, 2026
James A. Schoeneck
/s/ Jeffrey L. Edwards
Director
March 16, 2026
Jeffrey L. Edwards
/s/ Maykin Ho
Director
March 16, 2026
Maykin Ho, Ph.D.
/s/ Michael Kauffman
Director
March 16, 2026
Michael Kauffman, M.D., Ph.D.
122