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BUSINESS OVERVIEW
−Removed: FibroGen, Inc.
−Removed: (“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
−Removed: We are developing FG-3246, a potential first-in-class antibody-drug conjugate targeting CD46, for the treatment of metastatic castration-resistant prostate cancer and potentially other cancers.
+Added: Kyntra Bio, Inc.
+Added: (“Kyntra Bio” or “we”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
+Added: 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.
+Added: On January 8, 2026, our common stock began trading under the new Nasdaq symbol “KYNB.”
+Added: 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.
−Removed: We and our collaboration partners have developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in the People’s Republic of China (“China”), Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.
−Removed: In February 2025, we entered into a share purchase agreement (the “Share Purchase Agreement”) with AstraZeneca Treasury Limited pursuant to which we and our subsidiary FibroGen China Anemia Holdings, Ltd.
−Removed: agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd.
−Removed: (“FibroGen International”) to AstraZeneca Treasury Limited.
−Removed: AstraZeneca AB (“AstraZeneca”) is our long-time commercialization partner for roxadustat in greater China and South Korea.
−Removed: This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1% interest in Beijing Falikang Pharmaceutical Co.
+Added: 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.
+Added: 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.
+Added: On August 29, 2025, we closed the sale of our China operations through FibroGen International (Hong Kong) Ltd.
+Added: (“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.
+Added: AstraZeneca AB (“AstraZeneca”) was our long-time commercialization partner for roxadustat in greater China.
+Added: This sale included all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd.
+Added: (“FibroGen Beijing”) and its 51.1% interest in Beijing Falikang Pharmaceutical Co.
(“Falikang”).
−Removed: The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.
−Removed: We will retain 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.
+Added: 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”).
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one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
−Removed: We continue to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome, a high-value indication with significant unmet medical need.
+Added: 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.
+Added: We had a positive Type-C meeting with the U.S.
+Added: 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.
+Added: We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.
+Added: 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.
+Added: The FDA granted Roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.
Financial Highlights
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Accounts receivable
−Removed: Our revenue for the year ended December 31, 2024 primarily included the revenues recognized related to the following:
−Removed: • $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 (“AstraZeneca Termination and Transition Agreement”), with the exception of South Korea.
−Removed: • $2.0 million of drug product revenue related to active pharmaceutical ingredient (“API”) deliveries to Astellas;
−Removed: • $1.8 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca.
+Added: Long-term investments
+Added: 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:
+Added: • $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;
• $1.8 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca.
−Removed: • $1.0 million upfront payment, $3.0 million milestone payment based on Eluminex Biosciences (Suzhou) Limited (“Eluminex”) implanting a biosynthetic cornea in the first patient of its clinical trial in China and $3.0 million manufacturing related milestone payment, recognized under our license agreement and amendments with Eluminex;
−Removed: • $4.0 million regulatory milestone recognized under AstraZeneca China Agreement (defined further below) associated with the renewal of our right to continue to market roxadustat in China.
−Removed: Of this amount, $2.7 million was recognized as license revenue, $0.8 million was recognized as development revenue and the remainder was included in deferred revenue.
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:
−Removed: • $61.4 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;
• $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;
−Removed: • $24.9 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;
−Removed: • $24.6 million one-time, non-cash charge of acquired in-process research and development (“IPR&D”) expenses, in the nine-month period in prior year, associated with the exclusive license for FG-3246 from Fortis Therapeutics, Inc.
−Removed: (“Fortis”) and the acquisition of Fortis;
• $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;
−Removed: • $12.4 million lower outside services expenses due to termination of pamrevlumab programs, wind down of remaining obligations and cost control efforts;
+Added: • $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;
+Added: • $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;
+Added: • $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;
+Added: • $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;
• $8.0 million lower drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated.
−Removed: • $4.3 million lower legal expenses primarily due to lower activities in corporate legal, legal proceedings and intellectual properties;
−Removed: • $11.6 million higher cost of goods sold mainly correspondingly to the above-mentioned drug product revenue resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, as defined further below;
−Removed: • $6.8 million higher restructuring charge recorded related to the reduction in force plan in August 2024 with larger scale as compared to the reduction in force plan in July 2023.
Our research and development expenses were $23.5 million and $95.7 million for the years ended December 31, 2025 and 2024, respectively.
−Removed: Since inception and through December 31, 2024, 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 HIF-PH inhibitors.
−Removed: We expect to continue 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 product candidate portfolio.
+Added: 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.
+Added: 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.
−Removed: We implemented cost reduction efforts in 2023 and 2024 in connection with our efforts to streamline operations to align with our business goals.
+Added: 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.
−Removed: Cash and cash equivalents, investments and accounts receivable totaled $51.0 million at December 31, 2024, a decrease of $157.6 million from December 31, 2023, primarily due to cash used in operations, discussed under the Liquidity and Capital Resources section below.
+Added: 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.
+Added: 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.
+Added: For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the consolidated financial statement, and the Liquidity and Capital Resources section below.
+Added: 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
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The related drug product revenue was $0.8 million and $(2.9) million for the years ended December 31, 2025 and 2024, respectively.
−Removed: 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 FibroGen in support of commercial supplies (the “Astellas EU Supply Agreement”).
+Added: 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.
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and all territories except for China and those territories previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”).
−Removed: 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 FibroGen in support of commercial supplies.
−Removed: On February 23, 2024, we entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement with AstraZeneca, effective as of February 25, 2024.
+Added: 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.
+Added: 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.
−Removed: In addition, as a part of this AstraZeneca Termination and Transition Agreement, AstraZeneca will receive tiered mid-single digit royalties on FibroGen’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue FibroGen receives if it licenses or sells such rights to a third-party.
+Added: 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.
−Removed: In addition, resulting from the AstraZeneca Termination and Transition Agreement, FibroGen and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement.
+Added: 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.
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The aggregate amount for upfront payments and milestone payments received through December 31, 2025 totals $81.2 million.
−Removed: Under the AstraZeneca China Agreement, which is conducted through FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd.
−Removed: (“FibroGen Beijing”), and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”), the commercial collaboration was structured as a 50/50 profit share, which was amended by the AstraZeneca China Amendment in the third quarter of 2020, as discussed and defined below in AstraZeneca China Amendment .
−Removed: In September 2023, we received the formal notice, from Beijing Medical Products Administration, of renewal of its right to continue to market roxadustat in China through 2028.
−Removed: We evaluated the regulatory milestone payment associated with this renewal under the AstraZeneca China Agreement and concluded that this milestone was achieved in the third quarter of 2023.
−Removed: Accordingly, the consideration of $4.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement, all of which was recognized as revenue during the third quarter of 2023 from performance obligations satisfied.
+Added: 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.
+Added: For additional details, refer to Note 3, Discontinued Operations and Divestiture, to the consolidated financial statements.
AstraZeneca China Amendment
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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.
−Removed: W e account for our investment in Falikang under the equity method, and Falikang is not consolidated into our consolidated financial statements.
−Removed: Our proportionate share of the reported profits or losses of Falikang, is 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.
−Removed: See Note 3, Discontinued Operations , to the consolidated financial statements for details.
−Removed: Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.
−Removed: Substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in one province in China.
−Removed: FibroGen Beijing manufactures and supplies commercial product to Falikang.
−Removed: 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.
+Added: W e accounted for our investment in Falikang under the equity method, and Falikang was not consolidated into our consolidated financial statements.
+Added: 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.
+Added: See Note 3, Discontinued Operations and Divestiture , to the consolidated financial statements for details.
+Added: Product revenue, net, which was included in the discontinued operations, consisted primarily of revenues from sales of roxadustat commercial product to Falikang.
+Added: 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.
−Removed: In addition, AstraZeneca bills the co-promotion expenses to Falikang and to FibroGen Beijing, respectively, for its services provided to the respective entity.
−Removed: AstraZeneca is entitled to reimbursement of its sales and marketing expenses up to a cumulative capped amount of a percentage of net sales.
−Removed: Once such amount is reached, AstraZeneca will bill the co-promotion expenses based on actual costs as incurred plus a markup on a prospective basis, which is currently expected to continue through 2033.
−Removed: Such amount was reached during the year ended December 31, 2024.
−Removed: In addition, Development costs continue to be shared 50/50 between the Parties.
−Removed: We recognize revenue upon the transfer of control of commercial products to Falikang in an amount that reflects the allocation of transaction price of the China manufacturing and supply obligation (“China performance obligation”) to the performance obligation satisfied during the reporting period.
−Removed: For our direct sales of commercial drug product, we recognize revenue when control of the promised good is transferred to the customer in an amount that reflects the consideration that we expect to be entitled to in exchange for the product.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
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Exclusive License with Eluminex
−Removed: In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed).
−Removed: See the Eluminex Agreement section in Note 4, Collaboration Agreements, License Agreement and Revenues, to the consolidated financial statements for details.
+Added: 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).
RESULTS OF OPERATIONS
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(dollars in thousands)
−Removed: License revenue
Development and other revenue
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Total revenue
−Removed: Under our revenue recognition policy, license revenue includes amounts from upfront, non-refundable license payments and amounts allocated pursuant to the standalone selling price method from other consideration received during the respective periods.
−Removed: This revenue is generally recognized as deliverables are met and services are performed.
−Removed: License revenues represented 0% and 21% of total revenues for the years ended December 31, 2024 and 2023, respectively.
−Removed: Development revenue includes co-development and other development related services.
+Added: 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.
−Removed: For China co-development services, we defer revenue until we begin to transfer control of the manufactured commercial product to AstraZeneca, which commenced in the first quarter of 2021 and we expect to continue through 2033, which reflects our best estimates.
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.
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Drug product revenues represented 91% and 93% of total revenues for the years ended December 31, 2025 and 2024, respectively.
−Removed: The AstraZeneca U.S./RoW Agreement was terminated on February 23, 2024 (except for South Korea), while the AstraZeneca China Agreement and relationship continue unaffected.
+Added: The AstraZeneca U.S./RoW Agreement was terminated on February 25, 2024 (except for South Korea).
+Added: 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.
+Added: 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.
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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.
−Removed: License Revenue
−Removed: Years Ended December 31,
−Removed: (dollars in thousands)
−Removed: License revenue:
−Removed: Total license revenue
−Removed: License revenue decreased $9.6 million or 100% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
−Removed: We did not have any license revenue for the year ended December 31, 2024.
−Removed: License revenue recognized under our collaboration agreements with AstraZeneca for the year ended December 31, 2023 represented the allocated revenue related to $4.0 million regulatory milestone associated with the renewal of our right to continue to market roxadustat in China that was included in the transaction price during the third quarter of 2023 when such milestone was achieved.
−Removed: License revenue recognized for the year ended December 31, 2023 also included a $1.0 million upfront payment under the A&R Eluminex Agreement, a $3.0 million milestone payment based on Eluminex implanting a biosynthetic cornea in the first patient of its clinical trial in China, and a $3.0 million manufacturing related milestone payment when such milestones were achieved.
Development and Other Revenue
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Total development and other revenue
−Removed: Development and other revenue decreased $16.5 million, or 89% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
−Removed: Development revenue recognized under our collaboration agreements with Astellas for the year ended December 31, 2024 was impacted by the decrease in co-development billings due to the closeout activities under our collaboration agreements with Astellas for roxadustat.
−Removed: Development revenue recognized under our collaboration agreements with AstraZeneca for the year ended December 31, 2024 was the final development revenue as a result of the termination of the AstraZeneca U.S./RoW Agreement.
−Removed: Development revenue recognized under our collaboration agreements with AstraZeneca for the year ended December 31, 2023 also included the allocated revenue of $0.8 million related to the above-mentioned $4.0 million regulatory milestone associated with the renewal of our right to continue to market Roxadustat in China.
−Removed: Other revenue recognized for the two years ended December 31, 2024 included our contract manufacturing agreement with Eluminex, under which we are responsible for supplying the cornea product at 110% of our product manufacturing costs until our manufacturing technology is fully transferred to Eluminex, which occurred by the end of 2023, and ceased in the first quarter of 2024.
−Removed: Other revenue recognized for the year ended December 31, 2023 also included a $0.5 million upfront payment related to patent transfer under from Eluminex and revenue from sales of certain research and development material.
+Added: ________________________
+Added: NM = Not meaningful
+Added: 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.
Drug Product Revenue
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NM = Not meaningful
−Removed: Drug product revenue increased $8.9 million, or 48% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
+Added: 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
+Added: 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.
+Added: 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.
−Removed: During the second quarter of 2023, we fulfilled two shipment obligations under the terms of Astellas Japan Amendment, and recognized related drug product revenue of $14.4 million in the same period.
−Removed: In addition, 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 $1.3 million for the year ended December 31, 2023.
−Removed: 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, foreign exchange impacts and estimated yield from the manufacture of bulk product tablets, among others.
−Removed: 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, representing the Company’s best estimate of the timing for these amounts to be paid.
+Added: 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.
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AstraZeneca U.S./RoW Agreement
−Removed: As described above, pursuant to the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, FibroGen and AstraZeneca settled the outstanding balances relating to past transactions under the AstraZeneca Master Supply Agreement.
−Removed: 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, and received the cash during the second quarter of 2024.
−Removed: In addition, the related accrued liabilities of $11.2 million as of December 31, 2023 was settled during the second quarter of 2024.
+Added: 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.
+Added: 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
9 unchanged sentences
Cost of goods sold
−Removed: Cost of goods sold increased $11.6 million or 293% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
+Added: 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.
2 unchanged sentences
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.
−Removed: Cost of goods sold for the years ended December 31, 2024 and 2023 also included manufacturing costs $0.1 million and $0.8 million, respectively, related to our contract manufacturing revenue from Eluminex, which ceased in the first quarter of 2024.
Research and Development Expenses
−Removed: Research and development expenses consist of third-party research and development costs and the fully-burdened amount of costs associated with work performed under collaboration agreements.
+Added: 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.
1 unchanged sentence
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.
−Removed: Research and development expenses also include in-process research and development (“IPR&D”) assets that have no alternative future use other than in a particular research and development project.
We have implemented a significant cost reduction plan in the U.S.
−Removed: in the third quarter of 2024, and efforts to streamline operations to align with our business goals in the second half of 2023.
+Added: 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.
6 unchanged sentences
Total research and development expenses
−Removed: * Included $24.6 million one-time, non-cash acquired IPR&D expenses associated with the recent exclusive license for FG-3246 from Fortis and the acquisition of Fortis.
The program-specific expenses summarized in the table above include costs we directly attribute to our product candidates.
1 unchanged sentence
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:
+Added: • 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;
−Removed: • Decrease of $36.5 million in employee-related costs primarily due to the impact from reduction in force actions in August 2024 and July 2023, and cost control efforts;
−Removed: • $24.6 million one-time, non-cash charge of acquired IPR&D expenses, in the prior year, associated with the exclusive license for FG-3246 from Fortis and the acquisition of Fortis;
−Removed: • Decrease of $17.2 million in 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 during the third quarter of 2024;
−Removed: • Decrease of $13.4 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;
−Removed: • Decrease of $10.0 million in drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated;
−Removed: • Decrease of $7.0 million in outside services expenses primarily due to termination of pamrevlumab programs, wind down of remaining obligations and cost control efforts.
+Added: • 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;
+Added: • 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;
+Added: • 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
2 unchanged sentences
We have implemented a significant cost reduction plan in the U.S.
−Removed: in the third quarter of 2024, and efforts to streamline operations to align with our business goals in the second half of 2023.
+Added: 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:
−Removed: • Decrease of $15.0 million in employee-related costs primarily due to the impact from reduction in force actions in August 2024 and July 2023, and cost control efforts;
+Added: • 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;
−Removed: • Decrease of $5.4 million in outside services expenses due to cost control efforts;
−Removed: • Decrease of $4.3 million in legal expenses primarily due to lower activities in corporate legal, legal proceedings and intellectual properties.
+Added: • 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
1 unchanged sentence
workforce by approximately 75%.
−Removed: As a result, we 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.
−Removed: In July 2023, we approved a restructuring plan to lower our operating expenses.
−Removed: The restructuring plan included reducing our U.S.
−Removed: workforce by approximately 32%.
−Removed: As a result, we recorded a total of $12.6 million non-recurring restructuring charge during the third quarter of 2023, primarily consisting of notice period and severance payments, accrued vacation and employee benefits contributions.
+Added: As a result, we recorded a total of $19.5 million non-recurring restructuring charge during the year
+Added: ended December 31, 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions.
+Added: The related restructuring charges for the year ended December 31, 2025 were not material.
Interest and Other, Net
3 unchanged sentences
Interest expense
+Added: Loss on debt extinguishments
Interest income and other income (expenses), net
1 unchanged sentence
Interest Expense
−Removed: Interest expense represents the interest related to the senior secured term loan facilities, interest related to sale of future revenues and interest related to the Technology Development Center of the Republic of Finland product development obligations.
−Removed: Interest expense remained flat for the year ended December 31, 2024 compared to the year ended December 31, 2023, and primarily included interest expense of $7.9 million and $7.7 million, respectively, related to sale of future revenues under the Revenue Interest Financing Agreement (“RIFA”) with an affiliate of NovaQuest Capital Management (“NovaQuest”) entered into in November 2022.
+Added: 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.
+Added: 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.
+Added: (“NovaQuest”) entered into in November 2022.
See Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details.
+Added: Loss on Debt Extinguishments
+Added: 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.
+Added: Accordingly, we recorded a loss on debt extinguishments of $6.6 million for the year ended December 31, 2025.
+Added: See Note 8, Senior Secured Term Loan Facilities , to the consolidated financial statements for details.
Interest Income and Other Income (Expenses), Net
−Removed: 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 of our subsidiaries into the functional currency, realized gains (losses) on sales of investments, and other non-operating income and expenses.
+Added: 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.
−Removed: Benefit from Income Taxes
+Added: Benefits from Income Taxes
Years Ended December 31,
(dollars in thousands)
−Removed: Loss before income taxes
+Added: Loss from continuing operations before income taxes
Benefit from income taxes
Effective tax rate
−Removed: The provisions for income taxes for each of the two years ended December 31, 2024 were due to foreign taxes.
+Added: The benefits from income taxes for each of the two years ended December 31, 2025 were due to foreign taxes.
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.
3 unchanged sentences
agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited.
−Removed: AstraZeneca is our long-time commercialization partner for roxadustat in greater China and South Korea.
−Removed: This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1% interest in Falikang.
−Removed: The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.
+Added: This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1% interest in Falikang.
+Added: 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.
−Removed: See Note 3, Discontinued Operations , for details.
+Added: See Note 3, Discontinued Operations and Divestiture , for details.
LIQUIDITY AND CAPITAL RESOURCES
1 unchanged sentence
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.
+Added: 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:
+Added: (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.
+Added: 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.
+Added: See Note 3, Discontinued Operations and Divestiture , to the consolidated financial statements for details.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
1 unchanged sentence
For additional details about this financing transaction, see Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements.
−Removed: In February 2023, we entered into an Amended and Restated Equity Distribution Agreement (the “at-the-market agreement”) with Goldman Sachs & Co., LLC and BofA Securities, Inc.
−Removed: (each a “Sales Agent”), which amended and restated its Equity Distribution Agreement with Goldman Sachs & Co., LLC, dated August 8, 2022, to add BofA Securities, Inc.
−Removed: as an additional Sales Agent under that agreement.
−Removed: Under the at-the-market agreement, we could issue and sell, from time to time and through the Sales Agents, shares of our common stock having an aggregate offering price of up to $200.0 million.
−Removed: Under this ATM program, we sold 2,472,090 shares of our common stock and received net proceeds of approximately $48.4 million during the year ended December 31, 2023.
−Removed: We did not sell any shares of common stock under this ATM program during the year ended December 31, 2024.
−Removed: We terminated this at-the-market agreement in February 2025, in connection with entering into a new Equity Distribution Agreement with BofA Securities, Inc.
+Added: 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.
−Removed: See the At-the-Market Program section, in Note 13, Equity and Stock-based Compensation, to the consolidated financial statements for details.
−Removed: In April 2023, we entered into the Financing Agreement with investment funds managed by Morgan Stanley Tactical Value, (“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.
−Removed: 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.
−Removed: For additional details about this financing transaction, see Note 9, Senior Secured Revolving Line of Credit , to the consolidated financial statements.
−Removed: As of December 31, 2024, we had cash and cash equivalents of $50.5 million for our continuing operations, compared to $81.6 million as of December 31, 2023.
+Added: We did not sell any shares of common stock under this agreement during the year ended December 31, 2025.
+Added: 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.
−Removed: As of December 31, 2024, we did not have any short-term investments, compared to short-term investments of $121.9 million as of December 31, 2023.
−Removed: In addition, as of December 31, 2024, we had $51.7 million of cash and cash equivalents and $18.4 million of accounts receivable in China, which were included in the held for sale assets in the consolidated balance sheet.
−Removed: We will have access to the entirety of the cash, cash equivalents, and accounts receivable balances in China upon the close of the sales of FibroGen International to AstraZeneca Treasury Limited.
−Removed: During the year ended December 31, 2024, FibroGen Beijing made a total of $49.9 million repayments of intercompany loans.
−Removed: We have evaluated measures to access additional cash from our China operations and we believe the above-mentioned sale of FibroGen International represents the most efficient way to access the entirety of our cash from China upon closing of the transaction.
−Removed: The completion of the sale of FibroGen International, access to additional cash from our China operations and our capital contributions to FibroGen Beijing and the liquidity position of FibroGen Beijing depend on many factors, including those set forth under Part I, Item 1A “Risk Factors” in this Annual Report.
+Added: 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
6 unchanged sentences
Effect of exchange rate changes on cash and cash equivalents
−Removed: Net increase (decrease) in cash and cash equivalents
+Added: Net decrease in cash and cash equivalents
Operating Activities
+Added: 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.
+Added: 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.
+Added: The significant items in the changes in operating assets and liabilities included the following:
+Added: • 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.
+Added: See the China Performance Obligation section in Note 4, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details;
+Added: • 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.
+Added: The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment.
+Added: • 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.
+Added: • 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.
+Added: 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;
+Added: • 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.
+Added: See Note 9, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details;
+Added: • 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.
+Added: 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.
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.
4 unchanged sentences
• 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;
−Removed: See Note 5, Leases , to the consolidated financial statements for details;
• 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.
−Removed: See the Drug Product Revenue, Net section in Note 4, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details.
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;
1 unchanged sentence
• 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.
−Removed: Accounts receivable from Falikang is part of the held-for-sale assets resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited as discussed above and in Note 3, Discontinued Operations to the consolidated financial statements;
+Added: 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”).
−Removed: Inventory in China is part of the held-for-sale assets resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited as discussed above and in Note 3, Discontinued Operations to the consolidated financial statements;
−Removed: • 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 as discussed above and in Note 3, Discontinued Operations to the consolidated financial statements.
+Added: Inventory in China is part of the held-for-sale assets resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited;
+Added: • 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.
−Removed: Net cash used in operating activities was $315.0 million for the year ended December 31, 2023 and consisted primarily of net loss of $284.2 million adjusted for non-cash items and non-operating activities of $88.9 million and a net decrease in operating assets and liabilities of $119.7 million.
−Removed: The significant non-cash or non-operating cash items included stock-based compensation expense of $50.8 million, acquired IPR&D expenses associated with the acquisition of Fortis of $24.6 million, depreciation expense of $9.5 million, non-cash interest expense related to sale of future revenues of $7.7 million, and net accretion of premium and discount on investments of $5.1 million.
−Removed: The significant items in the changes in operating assets and liabilities included the following:
−Removed: • Accrued and other liabilities decreased $49.8 million, primarily due to the movements related to API and bulk drug product price true-up resulting 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, including the payment of $57.4 million previously accrued balance made during the current year period.
−Removed: The decrease was partially offset by the accrued liabilities of $28.5 million for the litigation settlement as of December 31, 2023, which is fully recoverable under our insurance policies.
−Removed: The accrued and other liabilities were also impacted by the timing of invoicing and payment;
−Removed: • Deferred revenue decreased $28.2 million, primarily related to related to the reclassification of $38.7 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 current year;
−Removed: • Accounts payable decreased $15.5 million, primarily driven by the payments made for the historical co-promotion expenses to AstraZeneca during the current year, as well as the timing of invoicing and payments;
−Removed: • Prepaid expenses and other current assets increased $28.2 million, primarily due to the $28.5 million receivable as of December 31, 2023 for the insurance recovery for the above-mentioned litigation settlement.
Investing Activities
−Removed: Investing activities primarily consist of purchases or disposal of property and equipment, purchases of investments, and proceeds from the maturity and sale of investments.
+Added: Investing activities primarily consist of net proceeds from divestiture, purchases of investments, and proceeds from the maturity and sale of investments.
+Added: 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;
+Added: 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.
−Removed: Net cash provided by investing activities was $153.7 million for the year ended December 31, 2023 and consisted primarily of $400.6 million of proceeds from maturities of investments and $6.7 million of proceeds from sales of available-for-sale securities, partially offset by $251.8 million of cash used in purchases of available-for-sale securities.
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.
+Added: 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.
+Added: See Note 8, Senior Secured Term Loan Facilities , to the consolidated financial statements for details.
+Added: 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.
+Added: 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.
−Removed: Net cash provided by financing activities was $122.7 million for the year ended December 31, 2023 and consisted primarily of $74.1 million net proceeds from senior secured term loan facilities, $48.4 million net proceeds received under the ATM Program and $3.7 million of proceeds from the issuance of common stock upon exercise of stock options and purchases under our Employee Share Purchase Plan.
Material Cash Requirements
−Removed: We generate revenue from commercial sales of roxadustat product in China, Japan and Europe.
−Removed: Even with the expectation of increases in these revenues and the sale of FibroGen International and its subsidiaries to AstraZeneca, we anticipate that we will continue to generate losses for the foreseeable future.
+Added: We generate revenue from commercial sales of roxadustat product in Japan and Europe.
+Added: 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.
−Removed: We expect to continue to incur significant research and development expenses to invest in our other programs and there is no guarantee that sufficient funds will be available to continue to fund these development efforts through commercialization or otherwise.
−Removed: 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 outlined under Part I, Item 1A “ Risk Factors ” in this Annual Report, as well as unknown factors that may adversely affect our business.
+Added: 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.
+Added: 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.
−Removed: If we are unable to complete the above mentioned sale of FibroGen International and its subsidiaries to AstraZeneca, access additional cash from our China operations, or raise additional capital in the United States, we would not have sufficient liquidity to continue operations in the U.S.
−Removed: for the 12 months from the date that the financial statements are issued and would not be able to comply with its financial covenant that requires a minimum balance of $30 million of unrestricted cash and cash equivalents to be held in accounts in the United States.
−Removed: In addition, there is a covenant under our senior secured credit facility to provide an annual audit report without a going concern qualification other than with respect to certain exceptions, of which we believe it meets an exception to such requirement.
−Removed: Upon an event of default, our senior secured term loan facilities could become immediately due and payable.
−Removed: We have evaluated measures to access additional cash from our China operations and believe the sale of FibroGen International represents the most efficient way to access the entirety of our cash from China upon closing of the transaction.
−Removed: There is also the potential that we raise additional funds in the U.S.
−Removed: at any time through equity, equity-linked, or debt financing arrangements or from other sources.
−Removed: There can be no assurances that these plans will be successful.
−Removed: As a result of these factors, we have determined that there is substantial doubt about our ability to continue as a going concern within 12 months after the date that the financial statements are issued.
−Removed: Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors.
−Removed: Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth under Part I, Item 1A “ Risk Factors ” in this Annual Report.
−Removed: We may not be able to secure additional financing to meet our operating requirements on acceptable terms, or at all.
−Removed: If we raise additional funds by issuing equity or equity-linked securities, the ownership of our existing stockholders will be diluted.
−Removed: If we raise additional financing by the incurrence of indebtedness, we will be subject to increased fixed payment obligations and could also be subject to restrictive covenants, such as limitations on our ability to incur additional debt, and other operating restrictions that could adversely impact our ability to conduct our business.
−Removed: If we are unable to obtain funding, we could delay, reduce or eliminate research and development programs, product portfolio development or future commercialization efforts which could adversely affect our business prospects.
Commitments and Contingencies
10 unchanged sentences
See Note 11, Commitments and Contingencies , to the consolidated financial statements for details.
−Removed: Under the Financing Agreement with Morgan Stanley Tactical Value, as of December 31, 2024, we had $73.1 million of senior secured term loan facilities balance on the consolidated balance sheets, which are not subject for repayment until May 2026.
−Removed: Meanwhile, we are obliged to pay interest on a monthly basis, for which we expect to pay a total of $10.5 million within the next 12 months.
−Removed: See Note 9, Senior Secured Term Loan Facilities , 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.
10 unchanged sentences
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.
−Removed: In addition, we are not a guarantor of the TEKES loans, and these loans are not repayable by FibroGen Europe until it has distributable funds.
+Added: 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.
19 unchanged sentences
Revenue Recognition
−Removed: Revenues under collaboration agreements
−Removed: Our collaboration agreements include multiple performance obligations comprised of promised services, or bundles of services, that are distinct.
−Removed: Services that are not distinct are combined with other services in the agreement until they form a distinct bundle of services.
−Removed: Our 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 , to our consolidated financial statements.
−Removed: Determining the performance obligations within a collaboration agreement often involves significant judgment and is specific to the facts and circumstances contained in each agreement.
−Removed: We have identified the following material promises under its collaboration agreements:
−Removed: (1) license of FibroGen 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.
−Removed: 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 , to our consolidated financial statements.
−Removed: For revenue recognition purposes, we determine that the terms of our collaboration agreements begin on the effective date and end upon the completion of all performance obligations contained in the agreements.
−Removed: In each agreement, the contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations.
−Removed: We believe that the existence of what we consider 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.
−Removed: The transaction price for each collaboration agreement is determined based on the amount of consideration we expect to be entitled for satisfying all performance obligations within the agreement.
−Removed: Our collaboration agreements include payments to us of one or more of the following:
−Removed: non-refundable upfront license fees;
−Removed: co-development billings;
−Removed: development, regulatory, and commercial milestone payments;
−Removed: payments from sales of API;
−Removed: payments from sales of bulk drug product and royalties on net sales of licensed products.
−Removed: 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 us.
−Removed: We do 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.
−Removed: Co-development billings resulting from our research and development efforts, which are reimbursable under its collaboration agreements, are considered variable consideration.
−Removed: 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.
−Removed: Prior to CKD approval in the third quarter of 2021, determining the amount of variable consideration from co-development billings required us to make estimates of future research and development efforts, which involves significant judgment.
−Removed: 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.
−Removed: Milestone payments are also considered variable consideration, which requires us to make estimates of when achievement of a particular milestone becomes probable.
−Removed: 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.
−Removed: Milestones are therefore included in the transaction price when achievement of the milestone becomes probable.
−Removed: For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, we recognize 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).
−Removed: To date, royalty revenue resulting from collaboration arrangements has been immaterial.
−Removed: We allocate the transaction price 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.
−Removed: The SSP is determined based on observable prices at which we separately sell the products and services.
−Removed: If an SSP is not directly observable, then we will estimate the SSP considering marketing conditions, entity-specific factors, and information about the customer or class of customer that is reasonably available.
−Removed: 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.
−Removed: 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.
−Removed: An enumeration of our significant judgments is outlined in Note 4, Collaboration Agreements, License Agreement and Revenues, to our consolidated financial statements.
−Removed: For each performance obligation identified within an arrangement, we determine the period over which the promised services are transferred and the performance obligation is satisfied.
−Removed: Service revenue that was recognized over time was based on progress toward complete satisfaction of the performance obligation.
−Removed: For each performance obligation satisfied over time, we assess 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.
−Removed: Revenue under license agreements
−Removed: Under a license agreement, if the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
−Removed: For licenses that are bundled with other promises, we determine whether the combined performance obligation is satisfied over time or at a point in time.
−Removed: If the combined performance obligation is satisfied over time, we use judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees.
−Removed: We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Drug product revenue
−Removed: 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 NDA or Marketing Authorization Application approval, and to Astellas for ongoing commercial activities in Japan and Europe.
+Added: 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.
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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.
−Removed: China performance obligation
−Removed: Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.
−Removed: Falikang is jointly owned by AstraZeneca and FibroGen Beijing.
−Removed: Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang.
−Removed: Falikang bears inventory risk once it receives and accepts the product from FibroGen Beijing, and is responsible for delivering product to its distributors.
−Removed: 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”).
−Removed: Amounts of the transaction price allocable to this performance obligation under our 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.
−Removed: The initiation of roxadustat sales to Falikang marked the beginning of the China performance obligation .
−Removed: Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang.
−Removed: Revenue is recognized based on the estimated transaction price per unit and actual quantity of product delivered during the reporting period.
−Removed: 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 we determined it is likely those sales would occur.
−Removed: The price per unit is subject to reassessment on a quarterly basis, which may result in adjustments due to changes in estimates.
−Removed: The overall transaction price for FibroGen Beijing’s product sales to Falikang includes the following elements of consideration:
−Removed: • Non-refundable upfront license fees;
−Removed: development, regulatory, and commercial milestone payments based on the AstraZeneca China Agreement allocated to the China performance obligation;
−Removed: • Co-development billings resulting from our research and development efforts, which are reimbursable under the AstraZeneca China Agreement;
−Removed: • Interim profit/loss share between FibroGen Beijing and AstraZeneca from April 1, 2020 through December 31, 2020;
−Removed: • Net transaction price from product sales to Falikang from January 1, 2021 onwards.
−Removed: The net transaction price includes the following elements:
−Removed: o Gross transaction price:
−Removed: 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.
−Removed: o Profit share:
−Removed: 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.
−Removed: The adjustments to date have been a reduction to the transaction price and the related accounts receivable from Falikang.
−Removed: The non-refundable upfront license fees constitute a fixed consideration.
−Removed: 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.
−Removed: 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.
−Removed: We defer any net transaction price in excess of the revenue recognized, and recognize it over future periods as the performance obligations are satisfied.
−Removed: 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 will be satisfied upon the closing of the divestiture FibroGen International.
−Removed: The product revenue recognized under the China performance obligation is included in discontinued operations for all periods presented.
Discontinued Operations
−Removed: On February 20, 2025, we entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.
−Removed: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited for an aggregate purchase price comprised of $85 million in cash for the enterprise value of FibroGen International, plus an additional cash amount equal to the net cash held in China by FibroGen International and its subsidiaries as of the closing.
−Removed: This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1% interest in Falikang.
−Removed: The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.
+Added: 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.
+Added: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited.
+Added: This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1% interest in Falikang.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: Accordingly, the consolidated balance sheets and the consolidated statements of operations, and the notes to the consolidated financial statements were recasted for all periods presented to reflect the discontinuation of FibroGen International in accordance with ASC 205.
−Removed: 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.
−Removed: See Note 3, Discontinued Operations , to our consolidated financial statements for related disclosures.
+Added: 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.
+Added: See Note 3, Discontinued Operations and Divestiture , to our consolidated financial statements for related disclosures.
QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISKS
2 unchanged sentences
CONSOLIDATED FINANCIAL ST ATEMENTS AND SUPPLEMENTARY DATA
−Removed: FibroGen, Inc.
+Added: Kyntra Bio, Inc.
Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
2 unchanged sentences
Consolidated Statements of Operations
−Removed: Consolidated Statements of Comprehensive Loss
+Added: Consolidated Statements of Comprehensive Income (Loss)
Consolidated Statements of Changes in Redeemable Non-controlling Interests and Stockholders’ Deficit
4 unchanged sentences
Report of Independent Regis tered Public Accounting Firm
−Removed: To the Board of Directors and Stockholders of FibroGen, Inc.
−Removed: Opinions on the Financial Statements and Internal Control over Financial Reporting
−Removed: We have audited the accompanying consolidated balance sheets of FibroGen, Inc.
−Removed: and its subsidiaries (the "Company") as of December 31, 2024 and 2023, and the related consolidated statements of operations, of comprehensive 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 (collectively referred to as the "consolidated financial statements").
−Removed: We also have audited the Company's internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
−Removed: In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, 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.
−Removed: Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
−Removed: Substantial Doubt About the Company's Ability to Continue as a Going Concern
−Removed: The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 2 to the consolidated financial statements, the Company needs to complete the sale of FibroGen International, access additional cash from its China operations, or raise additional capital in order to fund its United States operations and to comply with certain debt covenants under its senior secured short term loan facilities.
−Removed: These conditions raise substantial doubt about its ability to continue as a going concern.
−Removed: Management's plans in regard to these matters are also described in Note 2.
−Removed: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: Basis for Opinions
−Removed: The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 9A.
−Removed: Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits.
+Added: To the Board of Directors and Stockholders of Kyntra Bio, Inc.
+Added: Opinion on the Financial Statements
+Added: We have audited the accompanying consolidated balance sheets of Kyntra Bio, Inc.
+Added: 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").
+Added: 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.
+Added: Basis for Opinion
+Added: These consolidated financial statements are the responsibility of the Company’s management.
+Added: 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.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
−Removed: 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, and whether effective internal control over financial reporting was maintained in all material respects.
−Removed: Our audits of the consolidated financial statements 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.
+Added: We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB.
+Added: 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.
+Added: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: 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.
+Added: Accordingly, we express no such opinion.
+Added: 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.
−Removed: Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.
−Removed: Our audits also included performing such other procedures as we considered necessary in the circumstances.
−Removed: We believe that our audits provide a reasonable basis for our opinions.
−Removed: Definition and Limitations of Internal Control over Financial Reporting
−Removed: A company’s 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.
−Removed: A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
−Removed: (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
−Removed: and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
−Removed: Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
−Removed: Also, 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.
+Added: We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
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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.
−Removed: Determining the Transaction Price for Product Revenue Recognition for Sales to Beijing Falikang Pharmaceutical Co.
−Removed: As described in Notes 2, 3, and 4 to the consolidated financial statements, with respect to the roxadustat commercial product, revenue is recognized at a point in time when control of the product is transferred to Falikang.
−Removed: Total product revenue, net recognized related to sales to Falikang was $159.0 million for the year ended December 31, 2024.
−Removed: Revenue is recognized based on the estimated transaction price per unit and the actual quantity of product delivered to Falikang during the reporting period.
−Removed: The estimated 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 management determined it is likely those sales would occur.
−Removed: Management applied significant judgment in determining the transaction price per unit, which involved the use of significant assumptions such as (i) the estimated total gross transaction price and profit share, (ii) the estimated total sales quantity, and (iii) the estimated performance period in which the Company determined it is likely those sales would occur.
−Removed: The principal considerations for our determination that performing procedures relating to determining the transaction price for product revenue recognition for sales to Falikang is a critical audit matter are the significant judgment by management when determining the transaction price per unit, which in turn led to a high degree of auditor judgment, subjectivity, and effort in performing procedures and in evaluating management’s significant assumptions related to the estimated total gross transaction price, estimated total sales quantity, and estimated performance period over which the Company determined it is likely those sales would occur.
+Added: Discontinued Operations – FibroGen International
+Added: 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.
+Added: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited (the “Transaction”).
+Added: 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.
+Added: (“Falikang”).
+Added: The Transaction was closed on August 29, 2025.
+Added: 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.
+Added: The operating results of FibroGen International have been reflected as discontinued operations in the consolidated financial statements for all periods presented.
+Added: 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.
+Added: 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.
−Removed: These procedures included testing the effectiveness of controls relating to revenue recognition, including controls over the determination of the transaction price per unit for sales to Falikang.
−Removed: These procedures also included, among others, testing management’s process for determining the transaction price per unit, which included evaluating the appropriateness of the method, testing the completeness and accuracy of the data used in the method, and evaluating the reasonableness of significant assumptions related to the estimated total gross transaction price, estimated total sales quantity, and estimated performance period over which the Company determined it is likely those sales would occur.
−Removed: Evaluating the reasonableness of the significant assumptions used by management involved evaluating whether the assumptions were reasonable considering (i) the current and historical transaction price and quantity, (ii) the consistency with external market, industry and regulatory data, (iii) whether these assumptions were consistent with evidence obtained in other areas of the audit, and (iv) patent expiration and market exclusivity.
+Added: These procedures included, among others, (i) reading the purchase and close agreements;
+Added: (ii) evaluating the sufficiency of the disclosures in the consolidated financial statements;
+Added: (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
2 unchanged sentences
We have served as the Company’s auditor since 2000.
−Removed: FIBROGEN, INC.
+Added: KYNTRA BIO, INC.
CONSOLIDATED B ALANCE SHEETS
9 unchanged sentences
Total current assets
−Removed: Restricted time deposits
−Removed: Property and equipment, net
−Removed: Operating lease right-of-use assets
+Added: Long-term investments
Long-term assets held for sale
4 unchanged sentences
Deferred revenue
−Removed: Operating lease liabilities, current
Current liabilities held for sale
2 unchanged sentences
Deferred revenue, net of current
−Removed: Operating lease liabilities, non-current
Senior secured term loan facilities, non-current
11 unchanged sentences
Common stock, $ 0.01 par value;
−Removed: 225,000 shares authorized at December 31,
−Removed: 2024 and 2023;
−Removed: 100,917 and 98,770 shares issued and outstanding at
−Removed: December 31, 2024 and 2023
+Added: 225,000 shares authorized at December 31, 2025 and 2024;
+Added: 4,047 and 4,037 shares issued and outstanding at December 31, 2025 and 2024
Additional paid-in capital
1 unchanged sentence
Accumulated deficit
−Removed: Total stockholders’ deficit attributable to FibroGen
+Added: Total stockholders’ deficit attributable to Kyntra Bio
Nonredeemable non-controlling interests
2 unchanged sentences
The accompanying notes are an integral part of these Consolidated Financial Statements.
−Removed: FIBROGEN, INC.
+Added: KYNTRA BIO, INC.
CONSOLIDATED STATEM ENTS OF OPERATIONS
1 unchanged sentence
Years Ended December 31,
−Removed: License revenue
Development and other revenue
10 unchanged sentences
Interest expense
+Added: Loss on debt extinguishments
Interest income and other income (expenses), net
4 unchanged sentences
Income from discontinued operations, net of tax
+Added: Net income (loss)
Loss from continuing operations per share - basic and diluted
Income from discontinued operations per share - basic and diluted
−Removed: Net loss per share - basic and diluted
+Added: Net income (loss) per share - basic and diluted
Weighted average number of common shares used to calculate
−Removed: net loss per share - basic and diluted
+Added: net income (loss) per share - basic and diluted
The accompanying notes are an integral part of these Consolidated Financial Statements.
−Removed: FIBROGEN, INC.
−Removed: CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
+Added: KYNTRA BIO, INC.
+Added: CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
Years Ended December 31,
+Added: Net income (loss)
Other comprehensive income (loss):
Foreign currency translation adjustments
−Removed: Available-for-sale investments:
+Added: Cumulative currency translation adjustment attributable to divestiture
Unrealized gain (loss) on investments, net of tax effect
−Removed: Other comprehensive gain (loss), net of taxes
−Removed: Comprehensive loss
+Added: Other comprehensive income, net of taxes
+Added: Comprehensive income (loss)
The accompanying notes are an integral part of these Consolidated Financial Statements.
−Removed: FIBROGEN, INC.
+Added: KYNTRA BIO, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN redeemable non-controlling interests
4 unchanged sentences
December 31, 2023
−Removed: Consolidation of Fortis
Change in unrealized
1 unchanged sentence
Foreign currency
−Removed: Issuance of common
−Removed: stock under ATM
Shares issued from
5 unchanged sentences
Foreign currency
+Added: Cumulative currency
+Added: translation adjustment
+Added: attributable to
+Added: divestiture (Note 3)
+Added: Distribution to non-
+Added: controlling interest
Shares issued from
1 unchanged sentence
payroll taxes paid
+Added: Issuance cost under
+Added: Redemption of fractional
+Added: shares due to reverse
December 31, 2025
The accompanying notes are an integral part of these Consolidated Financial Statements.
−Removed: FIBROGEN, INC.
+Added: KYNTRA BIO, INC.
CONSOLIDATED STATEM ENTS OF CASH FLOWS
2 unchanged sentences
Operating activities
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Net income (loss)
+Added: Adjustments to reconcile net income (loss) to net cash used in
+Added: operating activities:
Amortization of finance lease right-of-use assets
1 unchanged sentence
Investment income in unconsolidated variable interest entity
+Added: Gain on divestiture
+Added: Loss on debt extinguishments
+Added: Impairment of property and equipment
Loss on disposal of property and equipment
Stock-based compensation
−Removed: Acquired in-process research and development expenses
−Removed: Non-cash interest expense related to sale of future revenues
Dividend received from unconsolidated variable interest entity
−Removed: Impairment of investment
−Removed: Realized loss on sales of available-for-sale securities
Changes in operating assets and liabilities:
13 unchanged sentences
Purchases of property and equipment
+Added: Proceeds from divestiture, net of cash transferred
Proceeds from sale of property and equipment
Purchases of available-for-sale securities
−Removed: Cash acquired from consolidation of Fortis
−Removed: Proceeds from sales of available-for-sale securities
Proceeds from maturities of investments
1 unchanged sentence
Financing activities
−Removed: Proceeds from senior secured term loan facilities, net of issuance costs
−Removed: Cash paid for transaction costs for senior secured term loan facilities
+Added: Repayments of senior secured term loan facilities
+Added: Payment of senior secured term loan facilities pay-off premium and fees
Repayments of finance lease liabilities
−Removed: Repayments of lease obligations
Cash paid for payroll taxes on restricted stock unit releases
−Removed: Proceeds from issuance of common stock under ATM Program, net of commissions
+Added: Cash paid to non-controlling interest
+Added: Payment of issuance cost under ATM Program
Proceeds from issuance of common stock under employee stock plans
−Removed: Net cash (used in) provided by financing activities
+Added: Net cash used in financing activities
Effect of exchange rate change on cash and cash equivalents
−Removed: Net increase (decrease) in cash and cash equivalents
+Added: Net decrease in cash and cash equivalents
Total cash and cash equivalents at beginning of period
1 unchanged sentence
Supplemental cash flow information:
−Removed: Non cash acquisition in Fortis
+Added: Holdback consideration receivable related to divestiture in prepaid expenses and other current assets
Interest payments
−Removed: Balance in accounts payable and accrued liabilities related to purchases
−Removed: of property and equipment
Reconciliation of cash and cash equivalents to the consolidated balance sheets:
5 unchanged sentences
The accompanying notes are an integral part of these Consolidated Financial Statements.
−Removed: FIBROGEN, INC.
+Added: KYNTRA BIO, INC.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: FibroGen, Inc.
−Removed: (“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
−Removed: The Company is developing FG-3246, an antibody-drug conjugate targeting CD46, for the treatment of metastatic castration-resistant prostate cancer and potentially other cancers.
+Added: Kyntra Bio, Inc.
+Added: (“Kyntra Bio” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
+Added: 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.
+Added: On January 8, 2026, the Company’s common stock began trading under the new Nasdaq symbol “KYNB.”
+Added: 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.
−Removed: The Company and its collaboration partners have developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in the People’s Republic of China (“China”), Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.
−Removed: On February 20, 2025, the Company entered into a share purchase agreement (the “Share Purchase Agreement”) with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.
−Removed: agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd.
−Removed: (“FibroGen International”) to AstraZeneca Treasury Limited.
−Removed: AstraZeneca AB (“AstraZeneca”) is the Company’s long-time commercialization partner for roxadustat in greater China and South Korea.
−Removed: This sale includes all of FibroGen’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1 % interest in Beijing Falikang Pharmaceutical Co.
−Removed: Ltd (“Falikang”).
−Removed: The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.
−Removed: FibroGen has retained the rights to roxadustat in the United States of America (“U.S.”), Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc.
+Added: 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.
+Added: 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.
+Added: On August 29, 2025, the Company closed the sale of its China operations through FibroGen International (Hong Kong) Ltd.
+Added: (“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.
+Added: AstraZeneca AB (“AstraZeneca”) was the Company’s long-time commercialization partner for roxadustat in greater China.
+Added: 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.
+Added: (“Falikang”).
+Added: For additional details, refer to Note 3, Discontinued Operations and Divestiture.
+Added: 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”).
1 unchanged sentence
one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
−Removed: The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome, a high-value indication with significant unmet medical need.
+Added: 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.
+Added: The Company had a positive Type-C meeting with the U.S.
+Added: 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.
+Added: The Company is starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.
+Added: 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.
+Added: The FDA granted Roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.
Summary of Significant Accounting Policies
1 unchanged sentence
The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S.
−Removed: 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 FibroGen is the primary beneficiary.
+Added: 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.
1 unchanged sentence
Discontinued Operations
−Removed: On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.
−Removed: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited for an aggregate purchase price comprised of $ 85 million in cash for the enterprise value of FibroGen International , plus an additional cash amount equal to the net cash held in China by FibroGen International and its subsidiaries as of the closing.
−Removed: This sale includes all of FibroGen’s roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1 % interest in Falikang.
−Removed: The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.
−Removed: The Company analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in FibroGen’s business and qualified as a discontinued operation.
−Removed: 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 Boards (“FASB”) Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements , as of December 31, 2024.
−Removed: Accordingly, the consolidated balance sheets and the consolidated statements of operations, and the notes to the consolidated financial statements were recasted for all periods presented to reflect the discontinuation of FibroGen International in accordance with ASC 205.
−Removed: 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.
−Removed: See Note 3, Discontinued Operations , for related disclosures.
−Removed: Unless otherwise noted, discussion in the notes to these consolidated financial statements, relates to solely to the Company’s continuing operations.
+Added: 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.
+Added: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited ( the “Transaction”) .
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: See Note 3, Discontinued Operations and Divestiture , for related disclosures.
+Added: Unless otherwise noted, discussion in the notes to the consolidated financial statements, relates to solely to the Company’s continuing operations.
+Added: Reverse Stock Split
+Added: On June 16, 2025, the Company effected a 1-for-25 reverse stock split (the “Reverse Stock Split”).
+Added: 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.
+Added: 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.
+Added: 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
1 unchanged sentence
GAAP applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business and does not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described below.
−Removed: If the Company is unable to complete the above mentioned sale of FibroGen International, access additional cash from its China operations, or raise additional capital in the United States, the Company would not have sufficient liquidity to continue operations in the U.S.
−Removed: for the 12 months from the date that the financial statements are issued and would not be able to comply with its financial covenant that requires a minimum balance of $ 30 million of unrestricted cash and cash equivalents to be held in accounts in the United States.
−Removed: In addition, there is a covenant under the Company’s senior secured credit facility to provide an annual audit report without a going concern qualification other than with respect to certain exceptions, of which the Company believes it meets an exception to such requirement.
−Removed: Upon an event of default, the Company’s senior secured term loan facilities could become immediately due and payable.
−Removed: The Company has evaluated measures to access additional cash from its China operations and believes the sale of FibroGen International represents the most efficient way to access the entirety of its cash from China upon closing of the transaction.
−Removed: There is also the potential that the Company raises additional funds in the U.S.
−Removed: at any time through equity, equity-linked, or debt financing arrangements or from other sources.
−Removed: There can be no assurances that these plans will be successful.
−Removed: As a result of these factors, the Company has determined that there is substantial doubt about its ability to continue as a going concern within 12 months after the date that the financial statements are issued.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: These factors had raised substantial doubt about the Company’s ability to continue as a going concern.
+Added: 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.
+Added: 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.
Foreign Currency Translation
1 unchanged sentence
The functional currency of FibroGen Europe is the Euro.
−Removed: The functional currency of FibroGen (China) Medical Technology Development Co., Ltd.
−Removed: (“FibroGen Beijing”) is CNY.
+Added: 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.
3 unchanged sentences
Resulting foreign currency translation adjustments are recorded directly in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity (deficit).
−Removed: The functional currency of FibroGen, Inc.
+Added: The functional currency of Kyntra Bio, Inc.
and all other subsidiaries is the U.S.
5 unchanged sentences
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.
−Removed: 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).
+Added: 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.
2 unchanged sentences
The Company is subject to risks associated with concentration of credit for cash and cash equivalents.
−Removed: Outside of short-term operating needs, cash on hand is invested in commercial paper and money market funds.
+Added: Outside of short-term operating needs, cash on hand is invested in commercial paper, money market funds and U.S.
+Added: government securities.
Any remaining cash is deposited with major financial institutions primarily in the U.S.
7 unchanged sentences
The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents.
−Removed: Cash and cash equivalents also include certain money market accounts and commercial paper.
−Removed: The Company did no t have any short-term or long-term investments as of December 31, 2024.
+Added: Cash and cash equivalents also include certain money market accounts, commercial paper and U.S.
+Added: government securities.
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.
10 unchanged sentences
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.
−Removed: The Company’s bad debt expense for the years ended the years ended December 31, 2024 and 2023 and the allowance for credit losses as of December 31, 2024 and 2023 were immaterial.
+Added: 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
9 unchanged sentences
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.
−Removed: The Company did no t have any available-for-sale debt securities as of December 31, 2024 .
Inventories are stated at the lower of cost or net realizable value, on a first-in, first-out, or FIFO, basis.
7 unchanged sentences
Inventory valuation adjustments require judgment including consideration of many factors, such as estimates of future product demand and product expiration period, among others.
−Removed: Property and Equipment
−Removed: Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method.
−Removed: Computer equipment, laboratory equipment, machinery and furniture and fixtures are depreciated over three to five years .
−Removed: Leasehold improvements are recorded at cost and amortized over the term of the lease or their useful life, whichever is shorter.
−Removed: The Company did no t have property and equipment as of December 31, 2024.
Variable Interest Entity
1 unchanged sentence
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.
−Removed: The Company determines if an arrangement is or contains a lease at inception date when it is given control of the underlying assets.
−Removed: The Company elected the practical expedient not to apply the lease recognition and measurement requirements to short-term leases, which is any lease with a term of 12 months or less as of the commencement date that does not include an option to purchase the underlying asset that the lessee is reasonably certain to exercise.
−Removed: Lease right-of-use (“ROU”) assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date.
−Removed: As its leases do not typically provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments.
−Removed: The Company reassesses the incremental borrowing rate periodically for application to any new leases or lease modifications, which approximates the rate at which the Company would borrow, on a secured basis, in the country where the lease was executed.
−Removed: For any lease modification, the Company reassesses the lease classification, remeasures the related lease liability using an updated discount rate, and adjusts the related ROU asset under the lease modification guidance under the ASC 842, Leases , (“ASC 842”).
−Removed: Lease ROU assets include any lease payments made and initial direct costs incurred.
−Removed: The Company has lease agreements with lease and non-lease components.
−Removed: The Company generally accounts for each lease component separately from the non-lease components, and excludes all non-lease components from the calculation of minimum lease payments in measuring the ROU asset and lease liability.
−Removed: The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.
−Removed: Lease expense for minimum lease payments is recognized on a straight-line basis over the lease terms.
−Removed: Regarding leases denominated in a foreign currency, the related ROU assets and the corresponding ROU asset amortization costs are remeasured using the exchange rate in effect at the date of initial recognition;
−Removed: the related lease liabilities are remeasured using the exchange rate in effect at the end of the reporting period;
−Removed: the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period.
−Removed: Operating leases are included in operating lease ROU assets, operating lease liabilities, current and non-current on the Company’s consolidated balance sheets.
−Removed: As of December 31, 2024, the Company did no t have any operating leases.
−Removed: The Company immaterial finance leases are immaterial and are included in other assets, accrued and other current liabilities, and other long-term liabilities on the Company’s consolidated balance sheets.
−Removed: Impairment of Long-Lived Assets
−Removed: The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its long-lived assets may warrant revision or that the carrying value of these assets may be impaired.
−Removed: If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset.
−Removed: Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group).
−Removed: Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, no ne of the Company’s long-lived assets were impaired.
−Removed: The Company had no impairment of long-lived assets for the years ended December 31, 2024 and 2023 .
Liability Related to Sale of Future Revenues
3 unchanged sentences
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 .
−Removed: Asset Acquisition
−Removed: The Company evaluates acquisitions of entities or assets to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets.
−Removed: If this screen criteria is met, the transaction is accounted for as an asset acquisition.
−Removed: If not, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business.
−Removed: The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the assets, which includes transaction costs.
−Removed: In an asset acquisition, the cost allocated to acquire in-process research and development (“IPR&D”) with no alternative future use is charged to research and development expense at the acquisition date.
−Removed: The Company recognizes assets acquired and liabilities assumed in asset acquisitions, including contingent assets and liabilities, and non-controlling interests (“NCI”) in the acquired assets at their estimated fair values as of the date of acquisition.
−Removed: An NCI represents the non-affiliated equity interest in the underlying entity or asset.
−Removed: The Company presents redeemable NCI in its consolidated statements of changes in equity within mezzanine equity.
−Removed: Nonredeemable NCI and redeemable NCI are initially recorded at their fair values.
−Removed: Subsequently, net loss in the underlying entity or asset is only allocated to nonredeemable NCI.
−Removed: Net income in the underlying entity or asset is allocated to nonredeemable NCI and redeemable NCI based on their respective stated rights.
Revenue Recognition
5 unchanged sentences
The Company has identified the following material promises under its collaboration agreements:
−Removed: (1) license of FibroGen 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.
+Added: (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 .
28 unchanged sentences
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.
−Removed: Revenue under license agreements
−Removed: Under a license agreement, if the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
−Removed: For licenses that are bundled with other promises, the Company determines whether the combined performance obligation is satisfied over time or at a point in time.
−Removed: If the combined performance obligation is satisfied over time, the Company uses judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees.
−Removed: The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
Drug product revenue
34 unchanged sentences
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.
−Removed: 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 will be satisfied upon the closing of the divestiture FibroGen International (see Discontinued Operations section above).
+Added: 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.
+Added: 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.
+Added: 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.
+Added: See Note 3, Discontinued Operations and Divestiture, for more details.
Research and Development Expenses
−Removed: Research and development expenses consist of above-mentioned expense for acquired IPR&D asset, independent research and development costs and the gross amount of costs associated with work performed under collaboration agreements.
+Added: 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.
32 unchanged sentences
Comprehensive Income (Loss)
−Removed: The Company is required to report all components of comprehensive income (loss), including net loss, in the consolidated financial statements in the period in which they are recognized.
+Added: 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.
1 unchanged sentence
Recently Adopted Accounting Guidance
−Removed: In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
−Removed: 2023-07, Segment Reporting (Topic 280):
−Removed: Improvements to Reportable Segment Disclosures, which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance.
−Removed: In addition, this guidance requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.
−Removed: This guidance is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024, with retrospective application required, and early adoption permitted.
−Removed: The Company adopted this guidance on its related disclosures.
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
+Added: 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.
+Added: This guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted.
+Added: The Company adopted this guidance in 2025 using a prospective transition method.
+Added: 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
4 unchanged sentences
The Company is currently in the process of evaluating the effects of this guidance on its related disclosures.
−Removed: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):
−Removed: 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.
−Removed: This guidance is effective for annual periods beginning after December 15, 2024, with early adoption permitted.
−Removed: The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
−Removed: Discontinued Operations
−Removed: On February 20, 2025, the Company entered into the Share Purchase Agreement with AstraZeneca Treasury Limited, pursuant to which FibroGen and its subsidiary FibroGen China Anemia Holdings, Ltd.
−Removed: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited for an aggregate purchase price comprised of $ 85 million in cash for the enterprise value of FibroGen International, plus an additional cash amount equal to the net cash held in China by FibroGen International and its subsidiaries as of the closing.
−Removed: This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd and its 51.1 % interest in Falikang.
−Removed: The transaction is expected to close by mid-2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation.
−Removed: The Company analyzed the quantitative and qualitative factors and concluded that the sale of FibroGen International represents a strategic shift in FibroGen’s business and qualified as a discontinued operation.
−Removed: As a result, Company determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with FASB ASC 205, Presentation of Financial Statements, as of December 31, 2024.
+Added: Discontinued Operations and Divestiture
+Added: 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.
+Added: agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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:
+Added: (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.
+Added: 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.
+Added: On November 6, 2025, the Company received a $ 6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $ 6.0 million, plus $ 0.4 million that was an additional payment following the final net cash adjustments after closing .
The financial results of the discontinued operations with respect to FibroGen International reflected in the consolidated statements of operations for the years ended December 31, 2025 and 2024 were as follows (in thousands):
9 unchanged sentences
Interest expense
+Added: Gain on divestiture
Interest income and other income (expenses), net
5 unchanged sentences
The product revenue, net, consists primarily of revenues from sales of roxadustat commercial product to Falikang, a distribution entity jointly owned by AstraZeneca and FibroGen Beijing, and is discussed in the China Performance Obligation section in Note 4, Collaboration Agreements, License Agreement and Revenues .
−Removed: 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 and 2023 were as follows (in thousands):
−Removed: December 31, 2024
+Added: 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.
+Added: 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
16 unchanged sentences
Investment income in unconsolidated variable interest entity
+Added: Gain on divestiture
+Added: Impairment of property and equipment
Dividend received from unconsolidated variable interest entity
Stock-based compensation
−Removed: Purchases of property and equipment
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.
2 unchanged sentences
The other income from Falikang were immaterial for the years ended December 31, 2025 and 2024.
−Removed: For the years ended December 31, 2024 and 2023, the investment income (loss) in Falikang was $ 4.0 million and $ 2.6 million, respectively.
−Removed: During the years ended December 31, 2024 and 2023, the Company received $ 2.2 million and $ 2.3 million of dividend distribution from Falikang, respectively.
−Removed: As of December 31, 2024 and 2023, the Company’s equity method investment in Falikang were $ 6.9 million and $ 5.3 million, respectively, which was included in the long-term assets held for sale on the consolidated balance sheets.
−Removed: As of December 31, 2024 and 2023 accounts receivable, net, from Falikang were $ 13.9 million and $ 5.2 million, respectively.
+Added: For the years ended December 31, 2025 and 2024, the investment income in Falikang was $ 2.5 million and $ 4.0 million, respectively.
+Added: 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.
+Added: 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.
Collaboration Agreements, License Agreement and Revenues
2 unchanged sentences
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”).
−Removed: Under this agreement, Astellas paid license fees and other consideration totaling $ 40.1 million (such amounts were fully received as of February 2009).
−Removed: Under the Astellas Japan Agreement, the Company is also eligible to receive from Astellas an aggregate of approximately $ 132.5 million in potential milestone payments, comprised of (i) up to $ 22.5 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of July 2016), (ii) up to $ 95.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $ 15.0 million in milestone payments upon the achievement of specified commercial sales milestone.
+Added: 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.
1 unchanged sentence
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.
−Removed: In 2018, FibroGen and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”).
−Removed: Under this amendment, FibroGen would continue to manufacture and supply roxadustat API to Astellas for the roxadustat commercial activities in Japan.
−Removed: 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 FibroGen.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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”).
+Added: Under this amendment, the Company would continue to manufacture and supply roxadustat API to Astellas for the roxadustat commercial activities in Japan.
+Added: 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.
1 unchanged sentence
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”).
−Removed: Under the terms of the Astellas Europe Agreement, Astellas paid license fees and other upfront consideration totaling $ 320.0 million (such amounts were fully received as of February 2009).
−Removed: The Astellas Europe Agreement also provides for additional development and regulatory approval milestone payments up to $ 425.0 million, comprised of (i) up to $ 90.0 million in milestone payments upon achievement of specified clinical and development milestone events (such amounts were fully received as of 2012), and (ii) up to $ 335.0 million in milestone payments upon achievement of specified regulatory milestone events.
+Added: 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.
2 unchanged sentences
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.
−Removed: Under the Astellas Europe Agreement, Astellas has an option to purchase roxadustat bulk drug product in support of commercial supplies.
−Removed: 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 FibroGen in support of commercial supplies.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
25 unchanged sentences
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.
−Removed: Through the third quarter of 2021 upon the approval of CKD, revenue was recognized over time based on progress toward complete satisfaction of the performance obligation.
−Removed: The Company used an input method to measure progress toward the satisfaction of the performance obligation, which was based on costs of labor hours and out-of-pocket expenses incurred relative to total expected costs to be incurred.
−Removed: Subsequently, the Company accounts for the development services for the indications related to chemotherapy-induced anemia and myelodysplastic syndromes (“MDS”) separately as services are provided.
+Added: 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.
15 unchanged sentences
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.
−Removed: License Revenue and Development Revenue Recognized Under the Astellas Agreements
−Removed: Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were no t material for the years ended December 31, 2024 and 2023 (in thousands):
−Removed: The transaction price related to consideration received through December 31, 2024 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Japan Agreement, including $ 100.3 million for license and $ 17.1 million for co-development.
−Removed: There was no license rev enue 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, 2024 under the Astellas Japan Agreement.
−Removed: 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.
−Removed: Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were as follows for the years ended December 31, 2024 and 2023 (in thousands):
−Removed: Years Ended December 31,
−Removed: Performance Obligation
−Removed: Astellas Europe Agreement
−Removed: Development revenue
−Removed: The transaction price related to consideration received through December 31, 2024 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Europe Agreement, including $ 619.0 million for license and $ 288.1 million for co-development.
−Removed: 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, 2024 under the Astellas Europe Agreement.
−Removed: 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.
AstraZeneca Agreements
−Removed: AstraZeneca U.S./Rest of World (“RoW”) Agreement
+Added: 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”).
−Removed: On February 23, 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement, effective as of February 25, 2024 (“AstraZeneca Termination and Transition Agreement”).
+Added: 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.
−Removed: In addition, as a part of this AstraZeneca Termination and Transition Agreement, AstraZeneca will receive tiered mid-single digit royalties on FibroGen’s sales of roxadustat in the terminated territories, or thirty-five percent of all revenue FibroGen receives if it licenses or sells such rights to a third-party.
+Added: 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.
1 unchanged sentence
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.
−Removed: Accordingly, during the three months ended March 31, 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the 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.
−Removed: The Company’s collaboration agreement with AstraZeneca for roxadustat in China, as described below, remains in place.
+Added: 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
−Removed: Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“AstraZeneca China Agreement”).
−Removed: Under the terms of the AstraZeneca China Agreement, AstraZeneca agreed to pay upfront consideration totaling $ 28.2 million (such amounts were fully received in 2014).
−Removed: Under the AstraZeneca China Agreement, the Company is also eligible to receive from AstraZeneca an aggregate of approximately $ 348.5 million in potential milestone payments, comprised of (i) up to $ 15.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $ 146.0 million in milestone payments upon achievement of specified regulatory milestone events, and (iii) up to approximately $ 187.5 million in milestone payments upon the achievement of specified commercial sales and other events.
−Removed: The AstraZeneca China Agreement is structured as a 50/50 profit or loss share (as defined), which was amended under the AstraZeneca China Amendment in 2020 as discussed and defined below, and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development period.
−Removed: The aggregate amount of the considerations received for milestone and upfront payments under the AstraZeneca China Agreement through December 31, 2024 totals $ 81.2 million .
−Removed: On September 18, 2023, the Company received the formal notice, from Beijing Medical Products Administration, of renewal of its right to continue to market roxadustat in China through 2028.
−Removed: The Company evaluated the regulatory milestone payment associated with this renewal under the AstraZeneca China Agreement and concluded that this milestone was achieved in the third quarter of 2023.
−Removed: Accordingly, the consideration of $ 4.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the AstraZeneca China Agreement, $ 3.5 million of which was recognized as revenue during the year ended December 31, 2023 from performance obligations satisfied or partially satisfied.
−Removed: A s of December 31, 2023, t he $ 4.0 million milestone was unbilled and recorded as a contract asset and fully netted against the contract liabilities (deferred revenue) related to the AstraZeneca China Agreement.
−Removed: During the third quarter of 2024, based on the arrangements under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items, the $ 4.0 million milestone was billed and received during the fourth quarter of 2024.
+Added: AstraZeneca was the Company’s long-time commercialization partner for roxadustat in greater China.
+Added: 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”).
+Added: Under the terms of the AstraZeneca China Agreement, AstraZeneca agreed to pay upfront consideration and potential milestone payments, totaling $ 376.7 million .
+Added: The aggregate amount of such considerations received for milestone and upfront payments through the third quarter of 2025 totals $ 81.2 million .
+Added: 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
1 unchanged sentence
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.
−Removed: Substantially all direct roxadustat product sales to distributors in China are made by Falikang, while FibroGen Beijing continues to sell roxadustat product directly in one province in China.
−Removed: FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transaction price, adjusted for the estimated profit share.
−Removed: In addition, AstraZeneca bills the co-promotion expenses to Falikang and to FibroGen Beijing, respectively, for its services provided to the respective entity.
−Removed: AstraZeneca is entitled to reimbursement of its sales and marketing expenses up to a cumulative capped amount of a percentage of net sales.
−Removed: Once such amount is reached, AstraZeneca will bill the co-promotion expenses based on actual costs as incurred plus a markup on a prospective basis, which is currently expected to continue through 2033.
−Removed: Such amount was reached during the year ended December 31, 2024.
−Removed: Development costs continue to be shared 50/50 between the Parties.
+Added: 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.
+Added: FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transfer price, which is adjusted for the estimated profit share.
+Added: Further discussion related to the sales to Falikang is discussed under the China Performance Obligation section below.
+Added: 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.
+Added: 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.
−Removed: The related net product revenue recognized from the sales to Falikang was $ 159.0 million and $ 89.1 million for the years ended December 31, 2024 and 2023, 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 .
+Added: 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
−Removed: 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.
−Removed: The key points the Company considered in reaching this conclusion are as follows:
−Removed: While the two agreements were largely negotiated separately, those negotiations proceeded concurrently, and were intended to be completed contemporaneously, presuming AstraZeneca decided to proceed with licenses in all regions available.
−Removed: Throughout negotiations for both agreements, the Company and the counterparties understood and considered the possibility that one arrangement may be executed without the execution of the other arrangement.
−Removed: However, the preference for the Company and the counterparties during the negotiations was to execute both arrangements concurrently.
−Removed: The two agreements were executed as separate agreements because different development, regulatory and commercial approaches required certain terms of the agreements to be structured differently, rather than because the Company or the counterparties considered the agreements to be fundamentally separate negotiations.
−Removed: Accordingly, as the agreements are being accounted for as a single arrangement, upfront and other non-contingent consideration received and to be received has been and will be 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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
−Removed: As of December 31, 2024 , the transaction price for the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement, excluding manufacturing services that is discussed separately below, included $ 402.2 million of non-contingent upfront payments, $ 118.0 million of variable consideration related to payments for milestones considered probable of being achieved, $ 616.3 million of variable consideration related to co-development billings.
+Added: 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.
1 unchanged sentence
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.
−Removed: For revenue recognition purposes, the Company determined that the terms of its collaboration agreements with AstraZeneca begin on the effective date and end upon the completion of all performance obligations contained in the agreements.
−Removed: The contract term is defined as the period in which parties to the contract have present and enforceable rights and obligations.
−Removed: The Company believes that the requirement to continue funding development for a substantive period of time and the loss of product rights, along with non-refundable upfront payments already remitted by AstraZeneca, represent substantive termination penalties that create significant disincentive for AstraZeneca to exercise its right to terminate the agreement.
−Removed: For the technology license under the AstraZeneca U.S./RoW Agreement, SSP was determined based on a two-step process.
−Removed: The first step involved determining an implied royalty rate that would result in the net present value of future cash flows to equal to zero (i.e.
−Removed: where the implied royalty rate on the transaction would equal the target return for the investment).
−Removed: This results in an upper bound estimation of the magnitude of royalties that a hypothetical acquirer would reasonably pay for the forecasted cash flow stream.
−Removed: The Company’s cash flow forecasts were derived from probability-adjusted revenue and expense projections.
−Removed: Such projections included consideration of taxes and cash flow adjustments.
−Removed: The probability adjustments were made after considering the likelihood of technical success at various stages of clinical trials and regulatory approval phases.
−Removed: The second step involved applying the implied royalty rate, which was determined to be 40 %, against the probability-adjusted projected net revenues by territory and determining the value of the license as the net present value of future cash flows after adjusting for taxes.
−Removed: The discount rate utilized was 17.5 %.
−Removed: AstraZeneca U.S./RoW Agreement:
−Removed: The promised services that were analyzed, along with their general timing of satisfaction and recognition as revenue, are as follows:
−Removed: (1) License to the Company’s technology existing at the effective date of the agreements.
−Removed: For the AstraZeneca U.S./RoW Agreement, the license was delivered at the beginning of the agreement term.
−Removed: The Company concluded that AstraZeneca has the knowledge and capabilities to fully exploit the license under the AstraZeneca U.S./RoW Agreement without the Company’s further involvement.
−Removed: Finally, 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 would not be expected to result in any significant modification or customization to the licensed technology.
−Removed: As such, the development services are separately identifiable from the licensed technology, indicating that the license is a distinct performance obligation.
−Removed: Therefore, the Company has concluded that the license is distinct and represents a performance obligation.
−Removed: The portion of the transaction price allocated to this performance obligation based on a relative SSP basis is recognized as revenue in its entirety at the point in time the license transfers to AstraZeneca.
−Removed: (2) Co-development services.
−Removed: 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 distinct.
−Removed: 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, and such an allocation is consistent with the allocation objective.
−Removed: Through the end of 2021, revenue was recognized over time based on progress toward complete satisfaction of the performance obligation.
−Removed: The Company used an input method to measure progress toward the satisfaction of the performance obligation related to CKD approval, 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.
−Removed: Subsequently, the Company accounts for the development services for other significant indications related to chemotherapy-induced anemia and MDS separately as services are provided.
−Removed: (3) Manufacturing of clinical supplies of products.
−Removed: 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.
−Removed: (4) Information sharing and committee service.
−Removed: These promises are satisfied throughout the course of the agreement as services are provided.
−Removed: Items (2)-(4) 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 delivering them independently is not practicable.
−Removed: 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.
−Removed: (5) Manufacturing commercial supplies of products.
−Removed: This promise is distinct as services are not interrelated with any of the other performance obligations.
−Removed: Revenue is recognized as supplies are shipped for commercial use during the commercialization period.
−Removed: The drug product revenue amount represents variable consideration and is estimated based on the quantity of product shipped and an estimated price for each individual purchase order.
−Removed: The estimated price is based on the contractual transfer price percentage applied on the estimated weighted average net sales price, which is estimated to be realized by AstraZeneca from the end sale of roxadustat in its approved territories.
−Removed: See the Drug Product Revenue, Net section below.
−Removed: AstraZeneca China Agreement:
−Removed: The promised services that were analyzed are consistent with the AstraZeneca U.S./RoW Agreement, except for license to the Company’s technology existing at the effective date of the agreement, described as follows:
−Removed: • License to the Company’s technology existing at the effective date of the agreement.
−Removed: The license was delivered at the beginning of the agreement term.
−Removed: However, the AstraZeneca China Agreement has contractual limitations that might affect AstraZeneca’s ability to fully exploit the license and therefore, potentially, the conclusion as to whether the license is distinct in the context of the agreement.
−Removed: In the AstraZeneca China Agreement, AstraZeneca does not have the right to manufacture commercial supplies of the drug.
−Removed: In order to determine whether this characteristic of the arrangement should lead to a conclusion that the license was not distinct in the context of the agreement, the Company considered the ability of AstraZeneca to benefit from the license on its own or together with other resources readily available to AstraZeneca.
−Removed: For the AstraZeneca China Agreement, the Company retained manufacturing rights as an essential part of a strategy to pursue domestic regulatory pathway for product approval, which requires the regulatory licensure of the manufacturing facility in order to commence commercial shipment.
−Removed: The prospects for the collaboration as a whole would have been substantially different had manufacturing rights been provided to AstraZeneca.
−Removed: The Company holds the rights to manufacture commercial drug product in China.
−Removed: Therefore, AstraZeneca cannot benefit from the license on its own or together with other readily available resources.
−Removed: Accordingly, all the promises identified, including the license, co-development services and manufacturing of commercial supplies, under the AstraZeneca China Agreement have been bundled into a single performance obligation and amounts of the transaction price allocable to this performance obligation are deferred until control of the manufactured commercial drug product has begun to transfer to AstraZeneca.
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.
1 unchanged sentence
See the China Performance Obligation section below.
−Removed: 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 .
−Removed: License Revenue and Development Revenue Recognized Under the AstraZeneca Agreements
−Removed: Amounts recognized as license revenue and development revenue under the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement were as follows for the years ended December 31, 2024 and 2023 (in thousands):
−Removed: Years Ended December 31,
−Removed: Performance Obligation
−Removed: AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement
−Removed: License revenue
−Removed: Development revenue
−Removed: The transaction price related to consideration received through December 31, 2024 and accounts receivable 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 $ 486.9 million for China performance obligation (with cumulative revenue of $ 354.8 million through December 31, 2024) that is recognized as product revenue, net included in discontinued operations as described under China Performance Obligation section below.
−Removed: There was no license rev enue 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, 2024.
+Added: 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
7 unchanged sentences
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.
−Removed: Any net transaction price in excess of the revenue recognized is added to the deferred balance to date, and will be recognized in future periods as the performance obligation is satisfied.
−Removed: 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 will be satisfied upon the closing of the divestiture FibroGen International.
−Removed: The product revenue recognized is included in discontinued operations.
−Removed: The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands):
+Added: 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.
+Added: 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.
+Added: As a result, all the previously deferred revenues were recognized as revenue during the third quarter of 2025.
+Added: The following table includes a roll-forward of the related deferred revenue that was considered as a contract liability that was not included in the disposal group held for sale as of December 31, 2024 (in thousands):
December 31, 2024
1 unchanged sentence
December 31, 2025
−Removed: AstraZeneca China performance obligation
−Removed: - deferred revenue
−Removed: Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca.
−Removed: As of December 31, 2024 , approximately $ 19.9 million of the above deferred revenue related to the China unit of accounting was included in short-term deferred revenue, which represents the amount of deferred revenue associated with the China unit of accounting that is expected to be recognized within the next 12 months, associated with the commercial sales in China.
+Added: AstraZeneca China performance
+Added: obligation - deferred revenue
+Added: 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.
Drug Product Revenue, Net
6 unchanged sentences
Astellas Japan Agreement
+Added: 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.
+Added: 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.
−Removed: During the second quarter of 2023, the Company fulfilled two shipment obligations under the terms of Astellas Japan Amendment, and recognized related drug product revenue of $ 14.4 million in the same period.
−Removed: In addition, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment and accordingly recorded an adjustment to the drug product revenue of $ 1.3 million for the year ended December 31, 2023.
−Removed: 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, foreign exchange impacts and estimated yield from the manufacture of bulk product tablets, among others.
−Removed: 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, representing the Company’s best estimate of the timing for these amounts to be paid.
+Added: 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 .
4 unchanged sentences
As a result, for the year ended December 31, 2025, the Company reclassified $ 1.8 million from the related deferred revenue to accrued liabilities.
+Added: 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.
2 unchanged sentences
As a result, for the year ended December 31, 2024, the Company reclassified $ 7.2 million from the related deferred revenue to accrued liabilities.
−Removed: The Company paid $ 35.3 million to Astellas during the year ended December 31, 2024.
−Removed: As of December 31, 2024 , the related balance in accrued liabilities was $ 10.5 million, representing the Company’s best estimate that this amount will be paid within the next 12 months.
−Removed: As of December 31, 2023, the related balance in accrued liabilities was $ 38.6 million.
−Removed: In addition, the Company recognized royalty revenue of $ 4.3 million and $ 2.3 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement during the years ended December 31, 2024 and 2023, respectively.
+Added: 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.
+Added: 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.
8 unchanged sentences
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.
−Removed: Accordingly, during the first quarter of 2024, the Company accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $ 25.7 million to the drug product revenue and received the cash during the second quarter of 2024.
−Removed: In addition, the related accrued liabilities of $ 11.2 million as of December 31, 2023 was settled during the second quarter of 2024.
−Removed: Corresponding to the drug product revenue, during the first quarter of 2024, the Company recorded the related cost of goods sold of $ 21.1 million.
−Removed: Eluminex Agreements
−Removed: In July 2021, FibroGen exclusively licensed to Eluminex Biosciences (Suzhou) Limited (“Eluminex”) global rights to its investigational biosynthetic cornea derived from recombinant human collagen Type III.
−Removed: Under the terms of the agreement with Eluminex , as amended and restated in January 2022, Eluminex made an $ 8.0 million upfront payment to FibroGen during the first quarter of 2022.
−Removed: In addition, FibroGen may receive up to a total of $ 64.0 million in future manufacturing, clinical, regulatory, and commercial milestone payments for the biosynthetic cornea program, as well as $ 36.0 million in commercial milestones for the first recombinant collagen III product that is not the biosynthetic cornea.
−Removed: FibroGen will also be eligible to receive mid single-digit to low double-digit royalties based upon worldwide net sales of cornea products, and low single-digit to mid single-digit royalties based upon worldwide n et sales of other recombinant human collagen type III products that are not cornea products.
−Removed: The Company accounted for this agreement under ASC 606, Revenue from Contracts with Customers , and identified one performance obligation at inception of the agreement related to the granting of the license rights to the investigational biosynthetic cornea derived from recombinant human collagen Type III.
−Removed: The Company based its assessment on the determination that Eluminex can benefit from the granted license on its own by developing and commercializing the underlying product using its own resources.
−Removed: All components of the transaction price in the agreement were allocated to the single performance obligation.
−Removed: The remaining future variable consideration related to future manufacturing, clinical, regulatory milestone payments as described above were fully constrained because the Company cannot conclude that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur, given the inherent uncertainties of success with these future milestones.
−Removed: For commercial milestones and royalties, the Company determined that the license is the predominant item to which the royalties or sales-based milestones relate and revenue will be recognized when the corresponding milestones and royalties are earned.
−Removed: In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed).
−Removed: The A&R Eluminex Agreement included additional total upfront payments of $ 1.5 million.
−Removed: For the year ended December 31, 2023, the Company recognized a $ 3.0 million milestone payment based on Eluminex implanting a biosynthetic cornea in the first patient of its clinical trial in China, a $ 3.0 million manufacturing related milestone payment and a $ 1.0 million upfront payment, as license revenue for the performance obligation satisfied and included in license revenue in the consolidated statement of operations.
−Removed: In addition, the Company recognized a $ 0.5 million upfront payment related to patent transfer under the A&R Eluminex Agreement as other revenue a nd included in development and other revenue in the consolidated statement of operations.
−Removed: During the first quarter of 2022, FibroGen and Eluminex entered into a separate contract manufacturing agreement, under which the Company was responsible for supplying the cornea product at cost plus 10 % of its product manufacturing costs until its manufacturing technology is fully transferred to Eluminex, which occurred by the end of 2023.
−Removed: The related contract manufacturing revenue was recorded as other revenue and included in development and other revenue in the condensed consolidated statement of operations.
−Removed: Such contract manufacturing activity was generally ceased during the first quarter of 2024.
−Removed: Amounts recognized as revenue under the agreements with Eluminex were as follows for the years ended December 31, 2024 and 2023 (in thousands):
−Removed: Years Ended December 31,
−Removed: Performance Obligation
−Removed: License revenue
−Removed: Other revenue - contract manufacturing
−Removed: Other revenue - patent transfer
−Removed: As part of its continuing efforts to reduce operating expenses and preserve cash, on September 27, 2024, the Company entered into an Agreement for Termination of Lease and Voluntary Surrender of Premises (“ Lease Termination Agreement ”) with its landlord, ARE-San Francisco No.43 Owner, LLC (“ARE”) related to the Company’s operating lease of its corporate headquarters in San Francisco, California.
−Removed: The Lease Termination Agreement modifies the lease agreement dated as of September 22, 2006, as subsequently amended and accelerates the expiration date of the term of the Lease from 2028 to no later than December 31, 2024.
−Removed: Pursuant to the Lease Termination Agreement, the Company paid ARE a total consideration of $ 10.0 million settlement amount, consisting of a $ 8.3 million of a one-time cash payment by FibroGen for past rent, FibroGen’s share of operating costs, taxes, insurance, utilities, and other costs and a lease modification payment;
−Removed: and a $ 1.7 million security deposit, in the form of a letter of credit.
−Removed: As of execution of this Lease Termination Agreement, FibroGen is not responsible for the payment of any further rent payments or operating costs, taxes, insurance, utilities, or any other scheduled monthly payments due under the lease to ARE.
−Removed: The Company ceased the use of the underlying operating lease right-of-use asset by September 30, 2024.
−Removed: As a result, during the third quarter of 2024, the Company derecognized the related operating lease right-of-use asset of $ 56.1 million and operating lease liabilities of $ 68.5 million, and recorded an approximately $ 1.7 million gain as credits to the selling, general and administrative expenses for the year ended December 31, 2024.
−Removed: As of December 31, 2024, the Company did not have any operating lease and restricted time deposit.
−Removed: In addition, the Company has several immaterial lease arrangements in the U.S.
−Removed: for office equipment, with contracted lease terms up to six years , treated as finance leases.
−Removed: The Company’s operating and finance leases were classified within the consolidated balance sheets as held for sale for all periods presented.
−Removed: See Note 3, Discontinued Operations , for details.
−Removed: The Company’s lease assets and related lease liabilities were as follows (in thousands):
−Removed: Balance Sheet Line Item
−Removed: Right-of-use assets cost
−Removed: Accumulated amortization
−Removed: Finance lease right-of-use assets, net
−Removed: Right-of-use assets cost
−Removed: Accumulated amortization
−Removed: Operating lease right-of-use assets, net
−Removed: Operating lease right-of-use assets
−Removed: Total lease assets
−Removed: Finance lease liabilities
−Removed: Accrued and other current liabilities
−Removed: Operating lease liabilities
−Removed: Operating lease liabilities, current
−Removed: Finance lease liabilities
−Removed: Other long-term liabilities
−Removed: Operating lease liabilities
−Removed: Operating lease liabilities, non-current
−Removed: Total lease liabilities
−Removed: The components of lease expense were as follows (in thousands):
−Removed: Years Ended December 31,
−Removed: Statement of Operations Line Item
−Removed: Finance lease cost:
−Removed: Amortization of
−Removed: right-of-use assets
−Removed: Cost of goods sold;
−Removed: Research and development;
−Removed: Selling, general and administrative expenses
−Removed: Operating lease cost
−Removed: Cost of goods sold;
−Removed: Research and development;
−Removed: Selling, general and administrative expenses
−Removed: Sublease income
−Removed: Selling, general and administrative expenses
−Removed: Total lease cost
−Removed: Lease term and discount rate were as follows:
−Removed: Weighted-average remaining lease term (years):
−Removed: Finance leases
−Removed: Operating leases
−Removed: Weighted-average discount rate:
−Removed: Finance leases
−Removed: Operating leases
−Removed: Supplemental cash flow information related to leases in the U.S.
−Removed: and China were as follows (in thousands):
−Removed: Years Ended December 31,
−Removed: Cash paid for amounts included in the measurement of lease liabilities:
−Removed: Operating cash flows from operating leases
−Removed: Operating cash flows from finance leases
−Removed: Financing cash flows from finance leases
−Removed: Right-of-use assets obtained in exchange for new lease liabilities:
−Removed: Finance leases
−Removed: Operating leases
+Added: 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.
Consolidated Variable Interest Entity - Fortis
−Removed: 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 antibody-drug conjugate, FOR46 (now referred to as “FG-3246”), that targets a novel epitope on CD46 preferentially expressed on certain cancer cells.
−Removed: FG-3246 is in development for the treatment of metastatic castration-resistant prostate cancer with potential applicability in other solid tumors and hematologic malignancies.
−Removed: If FibroGen exercises the option to acquire Fortis, it will pay Fortis an option exercise payment of $ 80.0 million, and thereafter, legacy Fortis shareholders would be eligible to receive from FibroGen up to $ 200.0 million in contingent payments associated with the achievement of various regulatory approvals.
−Removed: If FibroGen acquires Fortis, it would also be responsible to pay University of California, San Francisco (“UCSF”), an upstream licensor to Fortis, development milestone fees and a single digit royalty on net sales of therapeutic or diagnostic products arising from the licensing arrangement between Fortis and UCSF .
−Removed: If FibroGen chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.
−Removed: Pursuant to an evaluation agreement entered into with Fortis concurrent with the option agreement (together the “Fortis Agreements”), FibroGen has exclusively licensed FG-3246 and will control and fund future research, development, including a Phase 2 clinical study sponsored by FibroGen, and manufacturing of FG-3246 during the up-to four-year option period (which ends on the earlier of 120 days after Fortis or FibroGen submits data from any Phase 2 clinical trial of a product to the U.S.
−Removed: Food and Drug Administration for the purpose of progressing to a Phase 3 clinical trial or May 2027 absent extension).
−Removed: As part of the clinical development strategy, FibroGen will continue the work to develop a PET-based biomarker utilizing a radiolabeled version of the targeting antibody for patient selection.
−Removed: Additionally, the Company is obligated to make four quarterly payments totaling $ 5.4 million to Fortis in support of its continued development obligations, of which the last payment was $ 1.7 million and made during the three months ended March 31, 2024.
+Added: 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.
+Added: FG-3246 is in development for the treatment of mCRPC with potential applicability in other solid tumors and hematologic malignancies.
+Added: 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.
+Added: 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 .
+Added: If the Company chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.
+Added: 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).
+Added: 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.
+Added: 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.
−Removed: 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 IPR&D asset.
+Added: 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 .
1 unchanged sentence
Fortis has authorized and issued common shares and Series A preferred shares.
−Removed: As of the Option Acquisition Date and December 31, 2023, the Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired previously and carried at zero cost.
−Removed: The NCI attributable to the common shares is classified as nonredeemable NCI, as it is 100 % owned by third party shareholders.
−Removed: 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.
+Added: The Company owned approximately 2 % of Fortis’ Series A preferred shares, which was acquired prior the Option Acquisition Date and carried at zero cost.
+Added: 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.
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.
−Removed: The Company expensed fair value of the acquired IPR&D assets of $ 24.4 million as research and development expense in the consolidated statements of operations for the year ended December 31, 2023.
+Added: 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.
−Removed: For the year ended December 31, 2024 and the period from the Option Acquisition Date to December 31, 2023, Fortis’ net income (losses) was immaterial.
+Added: For the years ended December 31, 2025 and 2024 , Fortis’ net income (losses) was immaterial.
Fair Value Measurements
18 unchanged sentences
Money market funds
+Added: Corporate bonds
Commercial paper
2 unchanged sentences
Money market funds
−Removed: Corporate bonds
Commercial paper
7 unchanged sentences
Cash and cash equivalents consisted of the following (in thousands):
+Added: December 31, 2025
+Added: December 31, 2024
Commercial paper
2 unchanged sentences
Total cash and cash equivalents
−Removed: The Company did no t have any short-term or long-term investments as of December 31, 2024 .
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):
9 unchanged sentences
Total investments
−Removed: The following table summarizes, for all available for sale securities in an unrealized loss position as of December 31, 2023, the fair value and gross unrealized loss by length of time the security has been in a continual unrealized loss position (in thousands):
−Removed: December 31, 2023
−Removed: Less than 12 Months
−Removed: 12 Months or More
−Removed: Gross Unrealized
−Removed: Holding Losses
−Removed: Gross Unrealized
−Removed: Holding Losses
−Removed: Gross Unrealized
−Removed: Holding Losses
−Removed: Corporate bonds
−Removed: government bonds
+Added: 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.
2 unchanged sentences
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.
−Removed: Inventories consisted of the following (in thousands):
−Removed: Raw materials
−Removed: Work-in-progress
−Removed: Total inventories
−Removed: Resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement, as described under Note 4, Collaboration Agreements, License Agreement and Revenues , the Company was reimbursed $ 12.6 million for work-in-progress inventory, which was written off and recognized as cost of goods sold during the first quarter of 2024.
−Removed: The provision to write-down excess and obsolete inventory were immaterial as of December 31, 2024 and December 31, 2023.
+Added: 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):
+Added: December 31, 2025
+Added: December 31, 2024
Insurance proceeds receivable for litigation settlement
+Added: Holdback consideration receivable related to divestiture
Prepaid assets
1 unchanged sentence
Total prepaid expenses and other current assets
−Removed: As of December 31, 2024 and 2023, 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.
+Added: 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.
+Added: See Note 3, Discontinued Operations and Divestiture, for details.
+Added: 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.
+Added: Such amount was fully distributed during the first quarter of 2025.
+Added: 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.
−Removed: Property and Equipment
−Removed: Property and equipment consisted of the following (in thousands):
−Removed: Leasehold improvements
−Removed: Laboratory equipment
−Removed: Computer equipment
−Removed: Furniture and fixtures
−Removed: Total property and equipment
−Removed: accumulated depreciation
−Removed: Property and equipment, net
−Removed: The Company has disposed of all its property and equipment during the year ended December 31, 2024, as part of the efforts to streamline operations, and recorded $ 2.5 million of loss on disposal.
−Removed: Depreciation expense for the continuing operations for the years ended December 31, 2024 and 2023 was $ 1.2 million and $ 7.0 million respectively.
Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following (in thousands):
+Added: December 31, 2025
+Added: December 31, 2024
Preclinical and clinical trial accruals
6 unchanged sentences
Total accrued and other current liabilities
−Removed: The accrued liabilities of $ 13.1 million for API and bulk drug product price true-up as of December 31, 2024 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, and the bulk drug product shipments to AstraZeneca under the terms of the AstraZeneca Master Supply Agreement.
−Removed: During the second quarter of 2024, the Company paid $ 35.3 million to Astellas and $ 11.5 million to AstraZeneca related to accrued amounts.
+Added: 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.
+Added: 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.
−Removed: As of December 31, 2024 and 2023, 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.
+Added: 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.
2 unchanged sentences
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.
−Removed: Total cash payments under the reduction in force was $ 16.5 million during the year ended December 31, 2024.
−Removed: The remaining accrued restructuring charge was $ 4.6 million as of December 31, 2024 and will be substantially paid out in the first half of 2025.
−Removed: As of December 31, 2023, the remaining accrued restructuring charge was $ 3.7 million related to the restructuring plan in 2023 and was paid out by early 2024.
+Added: 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.
+Added: The remaining accrued restructuring charge of $ 0.5 million as of December 31, 2025 will be paid out in 2026.
Senior Secured Term Loan Facilities
−Removed: In April 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by Morgan Stanley Tactical Value, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of (i) a $ 75.0 million initial term loan (the “Initial Term Loan”), (ii) a $ 37.5 million delayed draw term loan that will be funded upon the achievement of certain clinical development milestones (“Delayed Draw Term Loan 1”) and, (iii) an uncommitted delayed draw term loan of up to $ 37.5 million to be funded at the Lenders sole discretion, (“Delayed Draw Term Loan 2” and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the “Term Loans”).
−Removed: Pursuant to the Financing Agreement, the Lenders have funded the Initial Term Loan.
−Removed: 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.
−Removed: As such, these features expired during 2023.
−Removed: The Company has determined that certain other features embedded within the Loan should be bifurcated and accounted for separately as a derivative.
−Removed: At inception and as of December 31, 2024, the fair values of such derivatives were negligible due to the low probability of the underlying events.
−Removed: The Term Loans shall accrue interest at a fixed rate of 14.0 % per annum, payable monthly in arrears.
−Removed: The Term Loans shall mature on May 8, 2026 .
−Removed: The Term Loans will not be subject to amortization payments.
−Removed: The Company is permitted to prepay the Term Loans from time to time, in whole or in part, subject to payment of a make-whole amount equal to the unpaid principal amount of the portion of the Term Loans being repaid or prepaid, plus accrued and unpaid interest of the portion of the Term Loans being repaid or prepaid, plus an amount equal to the remaining scheduled interest payments due on such portion of the Term Loans being repaid or prepaid as if such Term Loans were to remain outstanding until the scheduled maturity date.
−Removed: In May 2023, the Company received $ 74.1 million, representing the Initial Term Loan of $ 75.0 million net of $ 0.9 million issuance costs.
−Removed: The issuance costs and the related transaction costs, totaling $ 3.7 million is amortized as interest expense using the effective interest method over the term of the Initial Term Loan and are reported on the balance sheet as a direct deduction from the amount of the Initial Term Loan.
+Added: 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.
+Added: The Initial Term Loan accrued interest at a fixed rate of 14.0 % per annum, payable monthly in arrears.
+Added: The Initial Term Loan would mature on May 8, 2026 .
+Added: The Initial Term Loan was subject to amortization payments.
+Added: 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.
+Added: 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 .
−Removed: The Company recorded interest expense of $ 11.7 million and $ 7.4 million for the year ended December 31, 2024 and 2023, respectively, which were included in discontinued operations as the Company is required to repay the loan upon the closing of the divestiture FibroGen International.
−Removed: As of December 31, 2024 and 2023, the related accrued interest was $ 0.4 million, respectively.
−Removed: The Company was in compliance with all debt covenants associated with the senior secured term loan facilities as of December 31, 2024 , including maintaining a minimum balance of $ 30 million of unrestricted cash and cash equivalents held in accounts in the U.S.
−Removed: The Company has determined that certain other features embedded within the Loan should be bifurcated and accounted for separately as a derivative.
−Removed: At inception and as of December 31, 2024, the fair values of such derivatives were negligible due to the low probability of the underlying events.
−Removed: The Company’s senior secured term loan facilities as of December 31, 2024 and 2023 were as follows (in thousands):
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The Company’s senior secured term loan facilities as of December 31, 2024 were as follows (in thousands):
+Added: December 31, 2024
Principal of senior secured term loan facilities
1 unchanged sentence
Senior secured term loan facilities, ending balance
−Removed: Current Portion classified to accrued and other current liabilities
+Added: Representing:
+Added: Senior secured term loan facilities, current
Senior secured term loan facilities, non-current
Liability Related to Sale of Future Revenues
−Removed: In November 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with NQ Entity, L.P.
+Added: 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.
17 unchanged sentences
The Company’s estimated effective annual interest rate was 15.21 % as of December 31, 2025.
−Removed: The table below shows the activity of the liability related to sale of future revenues for the year ended December 31, 2024:
−Removed: December 31, 2024
+Added: The table below shows the activity of the liability related to sale of future revenues for the year ended December 31, 2025 and 2024:
+Added: For the Year Ended December 31,
Liability related to sale of future revenues - beginning balance
7 unchanged sentences
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.
−Removed: During the year ended December 31, 2024, the Company paid $ 5.7 million accrued interest.
+Added: 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.
6 unchanged sentences
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.
−Removed: The Company is not a guarantor of these loans, and these loans are not repayable by FibroGen Europe until it has distributable funds.
+Added: 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.
Commitments and Contingencies
Contract Obligations
−Removed: As of December 31, 2024, the Company had the following outstanding non-cancelable purchase obligations (in thousands):
−Removed: Purchase Obligations
−Removed: Due In The Year Ending December 31,
−Removed: General purchases and other programs
−Removed: Manufacture and supply of FG-3246
−Removed: Manufacture and supply of roxadustat
+Added: 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.
−Removed: See Note 9, Senior Secured Term Loan Facilities, Note 10, Liability Related to Sale of Future Revenues and Note 11, Product Development Obligations for details of the respective obligations.
+Added: 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
2 unchanged sentences
A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision.
−Removed: The Company did not have any material accruals for any active legal action, except for the class action settlement mentioned below, in its consolidated balance sheet as of December 31, 2024, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure.
−Removed: Between April 2021 and May 2021, five putative securities class action complaints were filed against FibroGen and certain of its former executive officers (collectively, the “Defendants”) in the U.S.
+Added: The Company did not have any material accruals for any active legal action, in its consolidated balance sheet as of December 31, 2025.
+Added: 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.
−Removed: The lawsuits allege that Defendants violated the Securities Exchange Act of 1934 by making materially false and misleading statements regarding FibroGen’s Phase 3 clinical studies data and prospects for U.S.
−Removed: Food and Drug Administration approval.
−Removed: On August 30, 2021, the Court consolidated the actions and appointed a group of lead plaintiffs.
On October 17, 2023, the parties reached an agreement in principle to settle the class action at $ 28.5 million.
−Removed: Accordingly, as of December 31, 2024 and 2023, the Company recorded the $ 28.5 million in accrued and other current liabilities in the consolidated balance sheet.
−Removed: The Company maintains insurance that covers exposure related to the class action lawsuit.
−Removed: As the amount is fully recoverable under the Company’s insurance policies, the Company recorded a corresponding receivable in prepaid expenses and other current assets in the consolidated balance sheet.
−Removed: 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.
−Removed: The Court preliminarily approved the settlement on February 13, 2024 and approved the settlement Plan of Allocation on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024, reserving further orders on the final judgment until after the claims and distribution process was completed.
−Removed: The court entered a class distribution order on January 1, 2025.
−Removed: Another case, filed on May 25, 2023, against the same defendants, asserting similar claims as the class action and additional common-law and California state fraud claims was voluntarily dismissed on December 20, 2023.
−Removed: Between July 30, 2021 and April 3, 2024, seven shareholder derivative complaints were filed, naming as defendants certain of the Company’s current and former officers and certain current and former members of the Company’s board, as well as FibroGen as nominal defendants (the “Derivative Lawsuits”).
−Removed: Of these Derivative Lawsuits, four were filed in the Delaware Court of Chancery, two were filed in the U.S.
−Removed: District Court for the District of Delaware (the “Delaware Federal Derivative Actions”), and one was filed in the U.S.
−Removed: District Court for the Northern District of California (the “California Federal Derivative Action”).
−Removed: The plaintiffs assert state and federal claims based on some of the same alleged misstatements as the securities class action complaint.
−Removed: The complaints seek unspecified damages, attorneys’ fees, and other costs.
−Removed: The status of the seven Derivative Lawsuits is currently as follows:
−Removed: • Two of the Delaware Chancery Derivative actions, filed on April 14, 2022, and June 1, 2023, have been consolidated (the “Delaware Chancery Consolidated Derivative”).
−Removed: On February 1, 2024, Defendants moved to dismiss the Delaware Chancery Consolidated Derivative action, which the Court granted on October 2, 2024.
−Removed: On October 30, 2024, the Delaware Chancery Consolidated Derivative was dismissed with prejudice.
−Removed: The other two derivative actions, filed in the Delaware Court of Chancery on December 3, 2023 and April 3, 2024 were consolidated and stayed pending resolution of the motion to dismiss the Delaware Chancery Consolidated Derivative action;
−Removed: • The Delaware Federal Derivative actions were voluntarily dismissed on November 14, 2024 and January 16, 2025;
−Removed: • The California Federal Derivative action was voluntarily dismissed on January 22, 2024.
−Removed: The Company believes that the claims asserted in the Derivative Lawsuits are without merit and it intends to vigorously defend against them.
−Removed: However, any litigation is inherently uncertain, and any judgment or injunctive relief entered against FibroGen or any adverse settlement could materially and adversely impact its business, results of operations, financial condition, and prospects.
−Removed: In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data.
+Added: The Court approved the settlement Plan of Allocation on May 28, 2024 and Plaintiffs’ motion for attorney’s fees on August 1, 2024.
+Added: The court entered a class distribution order on January 1, 2025 and the amount was fully distributed during the first quarter of 2025.
+Added: The settlement was fully covered by insurance.
+Added: In the fourth quarter of 2021, the Company received a subpoena from the U.S.
+Added: 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.
−Removed: The Company is fully cooperating with the SEC, and is currently discussing a potential resolution.
−Removed: The Company cannot predict the outcome.
−Removed: Any adverse outcome in this matter or any related proceeding could expose the Company to substantial damages, penalties, or reputational harm that may have a material adverse impact on the Company’s business, results of operations, financial condition, growth prospects, and price of its common stock.
−Removed: Between 2022 and 2024, the Company’s Board of Directors received seven litigation demands from purported shareholders of the Company, asking the Board of Directors to investigate and take action against certain current and former officers and directors of the Company for alleged wrongdoing based on the same allegations in the pending derivative and securities class action lawsuits.
−Removed: The Company may in the future receive additional similar demands.
−Removed: Starting in October 2021, certain challenges have been filed with the China National Intellectual Property Administration against patents which claim a crystalline form of roxadustat.
−Removed: Final resolution of such proceedings will take time and the Company could not predict the ultimate outcome, or reasonably estimate the potential exposure.
+Added: In May 2025, the Company entered into a settlement with the SEC.
+Added: 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.
+Added: In September 2025, the agreement was approved by the Commission and the Company has been making payments to the agreed upon payment schedule.
+Added: 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.
+Added: The litigation demands have been withdrawn.
Indemnification Agreements
1 unchanged sentence
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.
−Removed: The term of these indemnification agreements is generally perpetual any time after the execution of the agreement.
+Added: 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.
−Removed: The maximum potential amount of future payments the Company could be required to make under these arrangements is not determinable.
−Removed: The Company believes the estimated fair value of these arrangements is minimal.
+Added: There is currently one SEC complaint against the Company's former Chief Medical Officer in U.S.
+Added: District Court.
+Added: 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;
+Added: however, certain judgments, settlements, or fines sought by the SEC would not be covered by the Company under the indemnification agreement.
+Added: As of December 31, 2025, the Company’s accrued liabilities related to these obligations were not material.
+Added: 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.
Equity and Stock-based Compensation
+Added: On June 16, 2025, the Company effected the Reverse Stock Split.
+Added: 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 .
10 unchanged sentences
(“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.
−Removed: In February 2023, the Company entered into an Amended and Restated Equity Distribution Agreement (the “at-the-market agreement”) with Goldman Sachs & Co., LLC and BofA Securities, Inc.
−Removed: (each a “Sales Agent”), which amended and restated its Equity Distribution Agreement with Goldman Sachs & Co., LLC, dated August 8, 2022, to add BofA Securities, Inc.
−Removed: as an additional Sales Agent under that agreement.
−Removed: Under the at-the-market agreement, the Company could issue and sell, from time to time and through the Sales Agents, shares of its common stock having an aggregate offering price of up to $ 200.0 million.
−Removed: For the year ended December 31, 2023, the Company sold 2,472,090 shares under this ATM program, for proceeds of approximately $ 48.4 million, net of commissions to Sales Agents, at a weighted-average offering prices per share of $ 19.63 .
−Removed: The Company did no t sell any shares of common stock under this ATM program during the year ended December 31, 2024.
−Removed: The Company terminated this at-the-market agreement in February 2025, in connection with entering into the above-mentioned new Equity Distribution Agreement with BofA.
+Added: The Company did no t sell any shares of common stock under this ATM program during the years ended December 31, 2025.
Stock Option and RSU Plans
−Removed: Under the Company’s Amended and Restated 2005 Stock Plan (“2005 Stock Plan”), the Company may issue shares of Common Stock and options to purchase Common Stock and other forms of equity incentives to employees, directors and consultants.
−Removed: Options granted under the 2005 Stock Plan may be incentive stock options or nonqualified stock options.
−Removed: Incentive stock options may be granted only to employees and officers of the Company.
−Removed: Nonqualified stock options and stock purchase rights may be granted to employees, directors and consultants.
−Removed: The board of directors has the authority to determine to whom options will be granted, the number of options, the term and the exercise price.
−Removed: Options are to be granted at an exercise price not less than fair market value for an incentive stock option or a nonqualified stock option.
−Removed: Options generally vest over four years .
−Removed: Options expire no more than ten years after the date of grant.
−Removed: Upon the effective date of the registration statement related to the Company’s initial public offering, the 2005 Plan was amended to cease the grant of any additional awards thereunder, although the Company will continue to issue common stock upon the exercise of previously granted stock options under the 2005 Plan.
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.
−Removed: The 2014 Plan provides 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.
+Added: 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.
−Removed: Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule.
−Removed: Options generally expire ten years from the date of grant unless the optionee is a 10% stockholder, in which case the term will be five years from the date of grant.
+Added: Option vesting schedules were determined by the Company at the time of issuance and generally have a four year vesting schedule.
+Added: Options generally expire ten years from the date of grant .
Unvested options exercised are subject to the Company’s repurchase right.
−Removed: Shares reserved for issuance increases on January 1 of each year commencing on January 1, 2016 and ending on January 1, 2024 by the lesser of (i) the amount equal to 4 % of the number of shares issued and outstanding on December 31 immediately prior to the date of increase or (ii) such lower number of shares as may be determined by the board of directors.
In June 2024, the Company’s 2024 Equity Incentive Plan (the “2024 Plan”), the successor to and continuation of the 2014 Plan, became effective.
2 unchanged sentences
Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule.
−Removed: Options generally expire ten years from the date of grant unless the optionee is a 10% stockholder, in which case the term will be five years from the date of grant.
+Added: Options generally expire ten years from the date of grant.
Unvested options exercised are subject to the Company’s repurchase right.
11 unchanged sentences
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.
−Removed: 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 FibroGen’s common stock as compared to companies in the NBI index, and continued employment with the Company.
+Added: 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.
10 unchanged sentences
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.
−Removed: The total intrinsic value of options exercised during the years ended December 31, 2024 and 2023 was $ 0 and $ 0.9 million, respectively.
+Added: 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:
3 unchanged sentences
Unvested at December 31, 2025
−Removed: The numbers of PRSUs and TSR awards granted included in the table above reflect the shares that could be eligible to vest at 100 % of target number of shares.
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.
−Removed: The estimated weighted-average fair value of the awards granted during the years ended December 31, 2024 and 2023 was $ 1.78 and $ 11.61 , respectively.
+Added: There was no awards granted during the year ended December 31, 2025.
+Added: The estimated weighted-average fair value of the awards granted during the years ended December 31, 202 4 was $ 44.47 .
In September 2014, the Company adopted a 2014 ESPP that became effective in November 2014.
3 unchanged sentences
The 2014 ESPP is intended to qualify as an ESPP under Section 423 of the Internal Revenue Code.
−Removed: The Company has reserved 1,600,000 shares of its common stock for issuance under the 2014 ESPP and shares reserved for issuance increases January 1 of each year, which commenced on January 1, 2016, by the lesser of (i) a number of shares equal to 1 % of the total number of outstanding shares of common stock on December 31 immediately prior to the date of increase;
−Removed: (ii) 1,200,000 shares or (iii) such number of shares as may be determined by the board of directors.
−Removed: There were 354,132 shares and 361,911 shares purchased by employees under the 2014 ESPP during the years ended December 31, 2024 and 2023, respectively.
+Added: The Company has reserved 64,000 shares of its common stock for issuance under the 2014 ESPP.
+Added: 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.
47 unchanged sentences
FibroGen Europe
−Removed: As of December 31, 2024 and 2023 , respectively, FibroGen Europe had a total of 42,619,022 shares of Preferred Stock outstanding, of which there were 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 FibroGen, Inc.
−Removed: Common Stock.
+Added: 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.
+Added: 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.
+Added: 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:
18 unchanged sentences
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.
−Removed: Upon the initial public offering and as described above, all eligible FibroGen Europe preferred shares were exchanged for 958,996 shares of FibroGen Common Stock.
−Removed: No other FibroGen Europe shares have the right to be exchanged for FibroGen, Inc.
−Removed: Common Stock.
+Added: 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.
+Added: 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
−Removed: FibroGen Cayman had 6,758,000 Series A Preference Shares outstanding as of December 31, 2024 and 2023, respectively.
+Added: FibroGen Cayman has 15,836,966 Series A Preference Shares outstanding, including 10,484,260 shares owned by Kyntra Bio.
+Added: 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:
−Removed: Liquidation — In the event of liquidation, dissolution, or winding up of the Company, 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 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.
+Added: 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.
+Added: 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.
4 unchanged sentences
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 %.
−Removed: Non-Controlling Interests
−Removed: Non-controlling interest positions related to the issuance of subsidiary stock as described above are reported as a separate component of consolidated equity from the equity attributable to the Company’s stockholders at December 31, 2024 and 2023 .
−Removed: In addition, the Company does no t allocate losses to the non-controlling interests as the outstanding shares representing the non-controlling interest do not represent a residual equity interest in the subsidiary.
+Added: 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.
+Added: 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.
+Added: 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.
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.
−Removed: The Company reported a net loss for each of the years ended December 31, 2024 and 2023.
+Added: 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.
5 unchanged sentences
Years Ended December 31,
−Removed: Loss before provision for income taxes
−Removed: The provision for income taxes consists of the following (in thousands):
+Added: Loss before benefit for income taxes
+Added: The benefit for income taxes consists of the following (in thousands):
Years Ended December 31,
2 unchanged sentences
Benefit from income taxes
−Removed: The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate:
+Added: A reconciliation of the benefit for income taxes to the amount computed by applying the 21 % statutory U.S.
+Added: 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
Tax at statutory federal rate
+Added: State tax, net of federal benefit
+Added: Foreign Tax Effects
+Added: Foreign Rate Differential – Cayman Islands
+Added: Foreign Rate Differential – Finland
+Added: Effect of cross-border tax laws
+Added: Global intangible low-taxed income
+Added: Change in valuation allowance
+Added: Worldwide changes in unrecognized tax benefits
+Added: Nondeductible items
+Added: Stock based compensation
+Added: Disallowed interest
+Added: 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:
+Added: Years Ended December 31,
+Added: Tax at statutory federal rate
Stock-based compensation expense
20 unchanged sentences
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.
−Removed: The valuation allowance increased by $ 26.4 million and $ 66.8 million for the years ended December 31, 2024 and 2023, respectively.
+Added: 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.
10 unchanged sentences
The Company will continue to monitor trading activities in its shares which could cause ownership change in future years.
+Added: On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law.
+Added: 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.
+Added: 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.
+Added: The provisions do not have a material impact on the Company’s financial statements.
Uncertain Tax Positions
14 unchanged sentences
Unrecognized tax benefits may change during the next twelve months for items that arise in the ordinary course of business.
−Removed: The Company does not anticipate a material change to its unrecognized tax benefits over the next twelve months that would affect the Company’s effective tax rate.
The Company classifies interest and penalties as a component of tax expense, if any.
6 unchanged sentences
The Company is not currently under audit in any tax jurisdiction.
+Added: The Company did no t have any cash payment for income taxes for the years ended December 31, 2025 and 2024.
Segment and Geographic Information
1 unchanged sentence
The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”).
−Removed: 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 loss as the primary measurement.
+Added: 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.
+Added: These significant segment expenses include cost of goods sold, research and development expenses, selling, general and administrative expenses, and restructuring charge.
+Added: 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.
−Removed: As of December 31, 2024, the Company did no t have any property and equipment or operating lease right-of-use assets, and the Company’s finance lease right-of-use assets were all in the U.S.
−Removed: As of December 31, 2023, the Company’s property and equipment, operating lease right-of-use assets and finance lease right-of-use assets were all in the U.S.
Supplemental enterprise-wide information is presented below.
29 unchanged sentences
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.
−Removed: The effectiveness of the Company’s internal control over financial reporting as of December 31, 2024 has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report that appears herein.
+Added: 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
3 unchanged sentences
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.
+Added: We are implementing an enterprise resource planning (“ERP”) system, which will replace our existing operating and financial systems in the U.S.
+Added: in the first quarter of 2026.
+Added: 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.
OTHER INFORMATION
12 unchanged sentences
We have adopted a Code of Business Conduct and Ethics that applies to all of our directors, officers and employees.
−Removed: A copy of our Code of Business Conduct and Ethics can be found on our website ( www.FibroGen.com ) under “Corporate Governance.” The contents of our website are not a part of this Annual Report.
+Added: 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.
EXECUTI VE COMPENSATION
−Removed: The information required by this item is incorporated by reference to the sections titled “Executive Compensation,” “Director Compensation,” “Compensation Committee Interlocks and Insider Participation” and “Compensation Committee Report” appearing in our 2025 Proxy Statement.
+Added: 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.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OW NERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
17 unchanged sentences
Exhibit Description
−Removed: Amended and Restated Certificate of Incorporation of FibroGen, Inc.
−Removed: Amended and Restated Bylaws of FibroGen, Inc.
+Added: Amended and Restated Certificate of Incorporation.
+Added: Amended and Restated Bylaws.
+Added: First Amendment to Amended and Restated Bylaws.
+Added: Certificate of Amendment of the Amended and Restated Certificate of Incorporation.
+Added: Certificate of Amendment of the Amended and Restated Certificate of Incorporation.
Form of Common Stock Certificate.
Shareholders’ Agreement by and among FibroGen International (Cayman) Limited and certain of its shareholders, dated as of September 8, 2017.
−Removed: Common Stock Purchase Agreement by and between FibroGen, Inc.
−Removed: and AstraZeneca AB, dated as of October 20, 2014.
−Removed: Description of Capital Stock of FibroGen, Inc .
−Removed: FibroGen, Inc.
+Added: Description of Capital Stock .
2024 Equity Incentive Plan .
−Removed: Form of Restricted Stock Unit Grant Notice and Award Agreement.
−Removed: Form of Stock Option Grant Notice and Option Agreement.
−Removed: FibroGen, Inc.
+Added: Form of Restricted Stock Unit Grant Notice and Award Agreement (2024 Equity Incentive Plan) .
+Added: Form of Stock Option Grant Notice and Option Agreement (2024 Equity Incentive Plan) .
2014 Equity Incentive Plan and forms of agreement thereunder .
−Removed: FibroGen, Inc.
2014 Employee Stock Purchase Plan .
−Removed: FibroGen, Inc.
Non-Employee Director Compensation Policy, as amended, dated April 22, 2024.
−Removed: FibroGen, Inc.
−Removed: FibroGen Insider Trading and Trading Window Policy, amended and restated as of November 2021.
−Removed: Lease for Premises in Beijing BDA Biomedical Park by and among Beijing FibroGen Medical Technology Development Co., Ltd., Beijing Economic and Technology Investment Development Parent Company and Beijing BDA International Biological Pharmaceutical Investment Management Co., Ltd., effective as of February 1, 2013, as supplemented by the Supplementary Agreement to Lease of Premises in Beijing BDA Biomedical Park by and among Beijing FibroGen Medical Technology Development Co., Ltd., Beijing Economic Technology Investment Development Parent Company and Beijing BDA International Biological Pharmaceutical Investment Management Co., Ltd., dated as of January 30, 2013.
Form of Employment Offer Letter .
4 unchanged sentences
and Astellas Pharma Inc., effective as of January 1, 2013.
+Added: Amendment No.2 to Collaboration Agreement, by and between Astellas Pharma, Inc.
+Added: and FibroGen, Inc., dated June 6, 2025.
Anemia License and Collaboration Agreement, by and between FibroGen, Inc.
10 unchanged sentences
and Astellas Pharma Inc., dated as of May 10, 2012.
−Removed: Form of Indemnity Agreement by and between FibroGen, Inc.
+Added: Form of Indemnity Agreement by and between Kyntra Bio, Inc.
and its directors and officers .
5 unchanged sentences
and STA Pharmaceutical Hong Kong Limited, effective May 11, 2020 .
−Removed: Second Amended and Restated License, Development and Commercialization Agreement by and among FibroGen China Anemia Holdings, Ltd., FibroGen China Medical Technology Development Co., Ltd., FibroGen International (Hong Kong) Limited, and AstraZeneca AB, effective July 1, 2020 .
Amendment No.
5 unchanged sentences
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.
−Removed: Exclusive License and Option Agreement by and between FibroGen, Inc.
−Removed: and HiFiBiO (HK) Limited (D.B.A.
−Removed: HiFiBiO Therapeutics), dated as of June 16, 2021.
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.
−Removed: Offer Letter, by and between FibroGen, Inc.
−Removed: and Christine Chung, dated as of June 17, 2008.
−Removed: Amendment No.1 to the Exclusive License and Option Agreement, between HiFiBiO Inc.
−Removed: and FibroGen, Inc., dated February 14, 2024.
Form of Executive Officer Change in Control and Severance Agreement .
6 unchanged sentences
and its Affiliates and Catalent Pharma Solutions, LLC, effective as of January 1, 2023.
−Removed: Form of Executive Officer Change in Control and Severance Agreement.
Offer Letter, dated July 23, 2023, between FibroGen, Inc.
and Thane Wettig.
−Removed: Amended and Restated Exclusive License Agreement by and among FibroGen, Inc., FibroGen (China) Medical Technology Development Co., Ltd., and Eluminex Biosciences (Suzhou) Limited, dated April 19, 2023.
−Removed: Financing Agreement by and among FibroGen, Inc., certain of its subsidiaries, NHTV Fairview Holding LLC, NHTV II Fairview Holding LLC, MSTV Fund II Employees Fairview Holding LLC, and Wilmington Trust, National Association, dated as of April 29, 2023.
First Amended and Restated Evaluation Agreement by and between FibroGen, Inc.
1 unchanged sentence
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.
−Removed: Amendment No.
−Removed: 1 to the Second Amended and Restated Exclusive License Agreement, by and between FibroGen (China) Medical Technology Development Co., Ltd.
−Removed: and Eluminex Biosciences (Suzhou) Limited, dated as of November 16, 2023.
−Removed: Termination and Transition Agreement to Development and Commercialization Agreement (for the U.S.
−Removed: and Certain Other Territories), by and between AstraZeneca AB and FibroGen, Inc., dated February 25, 2024.
−Removed: Subsidiaries of FibroGen, Inc.
+Added: 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.
+Added: 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.
+Added: Termination Agreement by and between FibroGen, Inc.
+Added: and AstraZeneca AB, effective as of February 25, 2024, as amended and restated on August 29, 2025.
+Added: Share Purchase Agreement by and among AstraZeneca Treasury Limited, FibroGen China Anemia Holdings, Ltd., and FibroGen, Inc., dated as of February 20, 2025.
+Added: 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.
+Added: Insider Trading and Trading Window Policy .
+Added: Subsidiaries of Kyntra Bio, Inc.
Consent of PricewaterhouseCoopers LLP.
12 unchanged sentences
+ Indicates a management contract or compensatory plan.
−Removed: (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 FibroGen, Inc.
+Added: (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.
3 unchanged sentences
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.
−Removed: FIBROGEN, INC.
+Added: KYNTRA BIO, INC.
March 16, 2026
20 unchanged sentences
March 16, 2026
−Removed: /s/ Aoife Brennan
−Removed: March 17, 2025
−Removed: Aoife Brennan, M.B., B.Ch.
/s/ Jeffrey L.
3 unchanged sentences
Maykin Ho, Ph.D.
+Added: /s/ Michael Kauffman
+Added: March 16, 2026
+Added: Michael Kauffman, M.D., Ph.D.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.