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You should review the “Forward-Looking Statements” and ““Risk Factors” sections of this Annual Report for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
−Removed: This discussion and analysis generally addresses 2023 and 2022 items and year-over-year comparisons between 2023 and 2022.
−Removed: Discussions of 2021 items and year-over-year comparisons between 2022 and 2021 that are not included in this Annual Report can be found in “Item 7.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on February 27, 2023.
+Added: Unless noted otherwise, this management’s discussion and analysis relates solely to our continuing operations and does not reflect the operations results of FibroGen International (defined below), which is reflected as discontinued operations in our Consolidated Financial Statements.
BUSINESS OVERVIEW
−Removed: We are headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”).
−Removed: We are developing and commercializing a diversified pipeline of novel therapeutics that work at the frontier of cancer biology and anemia.
−Removed: We and Astellas Pharma Inc.
−Removed: (“Astellas”) are collaborating on the development and commercialization of roxadustat in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa.
−Removed: We and AstraZeneca AB (“AstraZeneca”) are collaborating on the development and commercialization of roxadustat in the United States (“U.S.”), China, and other markets in the Americas, Australia/New Zealand, and Southeast Asia.
−Removed: Our collaboration agreement with AstraZeneca AB (“AstraZeneca”) for roxadustat for the treatment of anemia in the U.S.
−Removed: and all territories except for China and those territories previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”) was terminated (except for South Korea) on February 23, 2024.
−Removed: However, our ongoing collaboration agreement with AstraZeneca for the development and commercialization of roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”) continues in full force and is unaffected.
−Removed: We are also developing earlier stage clinical and preclinical product candidates, FG-3246, FG-3165 and FG-3175, to address unmet patient needs in oncology.
+Added: FibroGen, Inc.
+Added: (“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
+Added: 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: This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent.
+Added: 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.
+Added: 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.
+Added: agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd.
+Added: (“FibroGen International”) to AstraZeneca Treasury Limited.
+Added: AstraZeneca AB (“AstraZeneca”) is our long-time commercialization partner for roxadustat in greater China and South Korea.
+Added: 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: (“Falikang”).
+Added: 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: 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: (“Astellas”).
+Added: Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements:
+Added: one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
+Added: 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.
Financial Highlights
3 unchanged sentences
Operating costs and expenses
−Removed: Net loss per share - basic and diluted
+Added: Loss from continuing operations
+Added: Loss from continuing operations per share - basic and diluted
December 31, 2024
3 unchanged sentences
Cash and cash equivalents
−Removed: Short-term and long-term investments
+Added: Short-term investments
Accounts receivable
−Removed: Our revenue for the year ended December 31, 2023 included the revenues recognized related to the following:
−Removed: • $100.9 million from roxadustat commercial sales in China, mostly from sales to Beijing Falikang Pharmaceutical Co.
−Removed: (“Falikang”);
+Added: 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 (“AstraZeneca Termination and Transition Agreement”), with the exception of South Korea.
• $2.0 million of drug product revenue related to active pharmaceutical ingredient (“API”) deliveries to Astellas;
• $1.8 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca.
+Added: As comparison, our revenue for the year ended December 31, 2023 primarily included the revenues recognized related to the following:
+Added: • $18.8 million of drug product revenue related to API deliveries to Astellas;
+Added: • $16.1 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca;
• $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;
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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.
−Removed: As comparison, our revenue for the year ended December 31, 2022 included the revenues recognized related to the following:
−Removed: • $25.0 million regulatory milestone recognized in the first quarter of 2022 under our collaboration agreements with our partner Astellas associated with the approval of EVRENZO® (roxadustat) in Russia.
−Removed: Of this amount, $22.6 million was recognized as license revenue and the remainder was included as development revenue;
−Removed: • $22.4 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca;
−Removed: • $82.9 million from roxadustat commercial sales in China, mostly from sales to Falikang;
−Removed: • $11.1 million of drug product revenue related to active pharmaceutical ingredient (“API”) deliveries to Astellas.
Total operating costs and expenses decreased $189.5 million for the year ended December 31, 2024 compared to the prior year as a result of the net effect of the following:
−Removed: • $37.8 million lower drug development expenses associated with drug substance and drug product manufacturing activities related to roxadustat post-approval safety studies in China and pamrevlumab which were largely completed in the prior periods;
−Removed: • $14.8 million lower stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units;
−Removed: • $3.8 million lower legal expenses primarily due to lower corporate legal activities;
−Removed: • $24.6 million one-time, non-cash charge of acquired in-process research and development (“IPR&D”) expenses associated with the recent exclusive license for FG-3246 from Fortis Therapeutics (“Fortis”) and the acquisition of Fortis;
−Removed: • $12.6 million of restructuring charge recorded in the third quarter of 2023 related to reduction in force actions in July 2023;
−Removed: • $4.8 million higher employee-related expenses primarily due to the impact from payroll tax refunds received during 2022 that did not recur in the current year, as well as more business travel activities and higher severance during the current year period, offset by the impact from reduction in force actions in July 2023;
−Removed: • $3.7 million higher outside services expenses due to higher consulting activities in roxadustat post-approval safety studies and efforts to prepare for commercialization in the first half of the year.
−Removed: Our research and development expenses were $282.9 million, $296.8 million and $387.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
−Removed: Since inception and through December 31, 2023, we have incurred a total of approximately $3.2 billion in research and development expenses, a majority of which relates to the development of roxadustat, pamrevlumab and other HIF-PH inhibitors.
+Added: • $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;
+Added: • $51.5 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;
+Added: • $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;
+Added: • $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.
+Added: (“Fortis”) and the acquisition of Fortis;
+Added: • $16.7 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;
+Added: • $12.4 million lower outside services expenses due to termination of pamrevlumab programs, wind down of remaining obligations and cost control efforts;
+Added: • $10.0 million lower drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated;
+Added: • $4.3 million lower legal expenses primarily due to lower activities in corporate legal, legal proceedings and intellectual properties;
+Added: • $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;
+Added: • $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.
+Added: Our research and development expenses were $95.7 million and $266.5 million for the years ended December 31, 2024 and 2023, respectively.
+Added: 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.
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.
−Removed: In addition, we expect to incur significant expenses relating to seeking regulatory approval for our product candidates and commercializing those products in various markets, including China.
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 started to implement a cost reduction effort in the second half of 2021, following the complete response letter (“CRL”) for roxadustat in the U.S., and in the second half of 2023 in connection with our efforts to streamline operations to align with our business goals.
+Added: We implemented cost reduction efforts in 2023 and 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.
−Removed: During the year ended December 31, 2023, we had a net loss of $284.2 million, or net loss per basic and diluted share of $2.92, as compared to a net loss of $293.7 million, or net loss per basic and diluted share of $3.14 for the prior year, primarily due to an increase in revenues and a decrease in operating costs and expenses.
−Removed: Cash and cash equivalents, investments and accounts receivable totaled $248.1 million at December 31, 2023, a decrease of $194.5 million from December 31, 2022, primarily due to cash used in operations, partially offset by the net proceeds received under our senior secured term loan facilities and at-the-market program, discussed under the Liquidity and Capital Resources section below.
+Added: During the year ended December 31, 2024, we had a loss from continuing operations of $153.1 million or loss from continuing operations per basic and diluted share of $(1.53), as compared to a loss from continuing operations of $323.0 million, or loss from continuing operations per basic and diluted share of $(3.32) for the prior year, primarily due to a decrease in operating costs and expenses, offset by a decrease in revenues.
+Added: 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.
Collaboration Partnerships for Roxadustat
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Under these agreements, the aggregate amount for upfront payments and milestone payments received through December 31, 2024 totals $790.1 million.
−Removed: On March 21, 2022, EVRENZO ® (roxadustat) was registered with the Russian Ministry of Health.
−Removed: We evaluated the regulatory milestone payment associated with the approval in Russia under the Astellas Europe Agreement and concluded that this milestone was achieved in the first quarter of 2022.
−Removed: Accordingly, the consideration of $25.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Astellas Europe Agreement, all of which was recognized as revenue during the first quarter of 2022 from performance obligations satisfied.
+Added: Based on the current development plans for roxadustat in Japan and Europe, we do not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement or the Astellas Europe Agreement.
In 2018, we and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”).
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The related drug product revenue was $4.9 million and $3.1 million for the years ended December 31, 2024 and 2023, respectively.
−Removed: In addition, Astellas has been an equity investor in FibroGen and considered a related party.
In July 2013, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in the U.S.
and all territories except for China and those territories previously licensed to Astellas (the “AstraZeneca U.S./RoW Agreement”).
+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 FibroGen in support of commercial supplies.
+Added: 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: 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.
+Added: 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: Neither party incurred any early termination penalties.
+Added: 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.
+Added: 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: Accordingly, during the first quarter of 2024, we recorded a cumulative catch-up net adjustment of $25.7 million to the drug product revenue.
In July 2013, through our China subsidiary and related affiliates, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in China (the “AstraZeneca China Agreement”).
The aggregate amount for upfront payments and milestone payments received through December 31, 2024 totals $81.2 million.
−Removed: On February 23, 2024, the AstraZeneca U.S./RoW Agreement was terminated (except for South Korea), while the AstraZeneca China Agreement and relationship continue unaffected.
Under the AstraZeneca China Agreement, which is conducted through FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd.
(“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 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: There was no related drug product revenue for the years ended December 31, 2023 and 2022.
−Removed: On September 18, 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.
+Added: 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.
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.
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W e account for our investment in Falikang under the equity method, and Falikang is not consolidated into our consolidated financial statements.
−Removed: In addition, we recognized our proportionate share of the reported profits or losses of Falikang, as other income (loss) in the consolidated statement of operations, and as an adjustment to investment in unconsolidated subsidiary in the consolidated balance sheet.
−Removed: See Note 5, Equity method investment - Variable Interest Entity , to the consolidated financial statements for details.
−Removed: S ubstantially 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.
+Added: 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.
+Added: See Note 3, Discontinued Operations , to the consolidated financial statements for details.
+Added: Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.
+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 one province in China.
+Added: FibroGen Beijing manufactures and supplies commercial product to Falikang.
+Added: 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.
FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transaction price, adjusted for the estimated profit share.
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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.
+Added: Such amount was reached during the year ended December 31, 2024.
In addition, Development costs continue to be shared 50/50 between the Parties.
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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.
−Removed: During the years ended December 31, 2023 and 2022, we recognized $89.1 million and $71.2 million of net product revenue from the sales to Falikang, respectively, and $11.9 million and $11.7 million of net product revenue from sales directly to distributors in one province in China, as described in details under Product Revenue, Net section below.
−Removed: Additional Information Related to Collaboration Agreements
−Removed: For more detailed discussions on the accounting for these agreements, See Note 3, Collaboration Agreements, License Agreement and Revenues, to the consolidated financial statements.
−Removed: Total cash consideration received through December 31, 2023 and potential cash consideration for upfront payments and milestone payments under our collaboration agreements are as follows:
−Removed: Cash Received for Upfront Payments and Milestone Payments
−Removed: December 31, 2023
−Removed: Cash Payment for Milestones
−Removed: Cash Payments for Upfront Payments and Milestones
−Removed: (in thousands)
−Removed: Astellas--related-party:
−Removed: Astellas Japan Agreement
−Removed: Astellas Europe Agreement
−Removed: Total Astellas
−Removed: AstraZeneca U.S./RoW Agreement
−Removed: AstraZeneca China Agreement
−Removed: Total AstraZeneca
−Removed: The above table does not include development cost reimbursement, transfer price payments, and royalties and profit share under our existing collaboration agreements.
−Removed: Based on our current development plans for roxadustat, we do not expect to receive most or all of these additional potential milestones.
−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: During the years ended December 31, 2024 and 2023, included in the discontinued operations, we recognized $159.0 million and $89.1 million of net product revenue from the sales to Falikang, and $14.7 million and $11.9 million of net product revenue from sales directly to distributors in one province in China, respectively.
Licensing Activities
Exclusive License with Eluminex
−Removed: In July 2021, we exclusively licensed to Eluminex global rights to our investigational biosynthetic cornea derived from recombinant human collagen type III.
−Removed: Under the terms of the agreement with Eluminex, 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 on worldwide net sales of other recombinant human collagen type III products that are not cornea products.
In April 2023, FibroGen and Eluminex entered into an Amended and Restated Exclusive License Agreement (“A&R Eluminex Agreement”) in order to add to the license rights to recombinant human collagen Type I (in addition to the rights to collagen Type III that were already licensed).
−Removed: The A&R Eluminex Agreement included additional total upfront payments of $1.5 million.
−Removed: For the year ended December 31, 2023, FibroGen 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, a $1.0 million upfront payment, and a $0.5 million upfront payment related to patent transfer.
−Removed: See the Eluminex Agreements section in Note 3, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details.
+Added: See the Eluminex Agreement section in Note 4, Collaboration Agreements, License Agreement and Revenues, to the consolidated financial statements for details.
RESULTS OF OPERATIONS
Years Ended December 31,
−Removed: Change 2023 vs.
(dollars in thousands)
1 unchanged sentence
Development and other revenue
−Removed: Product revenue, net
Drug product revenue, net
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As of December 31, 2024, 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, taking into account our estimated loss of exclusivity upon expiry of our composition of matter patent in 2024, our existing patent portfolio, and competition from generics.
+Added: 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.
Development and other revenues represented 7% and 39% of total revenues for the years ended December 31, 2024 and 2023, respectively.
−Removed: We recognize product revenue when our customer obtains control of promised goods or services in an amount that reflects the consideration we expect to receive in exchange for those goods or services.
−Removed: Product revenue represented 68%, 59% and 20% of total revenue for the years ended December 31, 2023, 2022 and 2021, respectively.
Drug product revenue includes commercial-grade API or bulk drug product sales to AstraZeneca, under the AstraZeneca U.S./RoW Agreement, and Astellas in support of pre-commercial preparation prior to the New Drug Application or marketing authorization application approval, and to Astellas for ongoing commercial activities in Japan and Europe.
3 unchanged sentences
Drug product revenues represented 93% and 40% of total revenues for the years ended December 31, 2024 and 2023, respectively.
−Removed: In the future, we will continue generating revenue from collaboration agreements in the form of license fees, milestone payments, reimbursements for collaboration services and royalties on drug product sales, and from product sales.
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: In the future, we will continue generating revenue from collaboration agreements in the form of milestone payments and royalties on drug product sales.
We expect that any revenues we generate will fluctuate from quarter to quarter due to the uncertain timing and amount of such payments and sales.
−Removed: Total revenue increased $7.0 million, or 5.0% for the year ended December 31, 2023 compared to the year ended December 31, 2022 for the reasons discussed in the sections below.
+Added: Total revenue decreased $17.2 million or 37% for the year ended December 31, 2024 compared to the year ended December 31, 2023 for the reasons discussed in the sections below.
License Revenue
Years Ended December 31,
−Removed: Change 2023 vs.
(dollars in thousands)
1 unchanged sentence
Total license revenue
−Removed: ________________________
−Removed: NM = Not meaningful
License revenue decreased $9.6 million or 100% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
+Added: We did not have any license revenue for the year ended December 31, 2024.
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.
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.
−Removed: License revenue recognized under our collaboration agreements with Astellas for the year ended December 31, 2022 represented the allocated revenue related to $25.0 million regulatory milestone associated with the approval of EVRENZO ® (roxadustat) in Russia that was included in the transaction price during the first quarter of 2022 when such milestone was achieved.
Development and Other Revenue
Years Ended December 31,
−Removed: Change 2023 vs.
(dollars in thousands)
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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, 2023 was impacted by the decrease in co-development billings due to substantial completion of Phase 3 trials for roxadustat under our collaboration agreements with Astellas for roxadustat.
−Removed: Development revenue recognized under our collaboration agreements with Astellas for the year ended December 31, 2022 included the allocated revenue of $2.4 million related to the above-mentioned $25.0 million regulatory milestone associated with the approval in Russia during the first quarter of 2022, which did not recur in 2023.
−Removed: Development revenue recognized under our collaboration agreements with AstraZeneca for the year ended December 31, 2023 was impacted by the decrease in co-development billings due to the closeout activities under our collaboration agreements with AstraZeneca for roxadustat, which was partially offset by 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 year ended December 31, 2023 included an upfront payment related to patent transfer under from Eluminex, revenue from sales of certain research and development material, as well as revenue related to our contract manufacturing agreement with Eluminex, under which we were 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.
−Removed: Product Revenue, Net
−Removed: Years Ended December 31,
−Removed: Change 2023 vs.
−Removed: (dollars in thousands)
−Removed: Direct Sales:
−Removed: Gross revenue
−Removed: Discounts and rebates
−Removed: Sales returns
−Removed: Direct sales revenue, net
−Removed: Sales to Falikang:
−Removed: Gross transaction price
−Removed: Net transaction price
−Removed: Decrease (increase) in deferred revenue
−Removed: Sales to Falikang revenue, net
−Removed: Total product revenue, net
−Removed: Substantially all direct product sales to distributors in China have been made by Falikang, while FibroGen Beijing continues to sell product directly in one province in China.
−Removed: Total product revenue, net increased $18.1 million, or 22% for the year ended December 31, 2023 compared to the year ended December 31, 2022.
−Removed: We recognize product revenue from direct sales to distributors in an amount that reflects the consideration that we expect to be entitled to in exchange for those products, net of various sales rebates and discounts.
−Removed: Product revenue from direct sales, net increased $0.2 million, or 2% for the year ended December 31, 2023 compared to the year ended December 31, 2022.
−Removed: The gross product revenue from direct sales to distributors increased $0.8 million, or 7% for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to an increase in sales volume.
−Removed: The discounts and rebates primarily consisted of the price adjustments recorded based on government-listed price guidance and estimated channel inventory levels, the contractual sales rebate calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor, and other rebates and discounts, as well as sales return allowance.
−Removed: The total discounts and rebates were immaterial for the years ended December 31, 2023 and 2022.
−Removed: FibroGen Beijing manufactures and supplies commercial product to Falikang based on a gross transaction price, adjusted for the estimated profit share.
−Removed: We recognize revenue upon the transfer of control of commercial products to Falikang in an amount that reflects the allocation of the China performance obligation transaction price to the performance obligation satisfied during the reporting period.
−Removed: The variable consideration components that are included in the transaction price may be constrained, and are included in the product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: Sales to Falikang revenue, net increased $17.9 million, or 25% for the year ended December 31, 2023 compared to the year ended December 31, 2022.
−Removed: The gross transaction price increased $42.3 million and the calculated profit share increased $22.5 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, respectively, primarily due to the increase in sales volume.
−Removed: Periodically, we update our assumptions such as total sales quantity, performance period, gross transaction price, profit share and other inputs including foreign currency translation impact, among others.
−Removed: Following updates to our estimates, we recognized $0.5 million and $2.3 million from the previously deferred revenue of the China performance obligation during the years ended December 31, 2023 and 2022, respectively.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Drug Product Revenue
Years Ended December 31,
−Removed: Change 2023 vs.
(dollars in thousands)
4 unchanged sentences
Total drug product revenue, net:
+Added: ________________________
+Added: NM = Not meaningful
Drug product revenue increased $8.9 million, or 48% for the year ended December 31, 2024 compared to the year ended December 31, 2023.
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 a reduction to the drug product revenue of $2.9 million for the year ended December 31, 2024.
+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.
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.
1 unchanged sentence
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: During the first quarter of 2022, we fulfilled a shipment obligation under the terms of Astellas Japan Amendment and recognized related drug product revenue of $9.8 million in the same period.
−Removed: During the fourth quarter of 2022, we fulfilled a shipment obligation under the terms of Astellas Japan Amendment, and recognized related drug product revenue of $8.4 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 Japan Amendment with Astellas, and recorded a reduction to the drug product revenue of $8.7 million during the year ended December 31, 2022 .
−Removed: Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect foreign currency translation impact, the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, estimated cost to convert the API to bulk product tablets, and estimated yield from the manufacture of bulk product tablets, among others .
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.
−Removed: As of December 31, 2022, the related balance in accrued liabilities was $6.5 million.
+Added: As of December 31, 2023, the related balances were $1.2 million in accrued liabilities and $0.7 million in other long-term liabilities.
Astellas Europe Agreement
4 unchanged sentences
As of December 31, 2024, the related balance in accrued liabilities was $10.5 million, representing our best estimate that this amount will be paid within the next 12 months.
−Removed: During the second quarter of 2022, we transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $1.0 million as drug product revenue, and recorded $23.2 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes.
+Added: During the fourth quarter of 2023, we transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $0.8 million as drug product revenue, and recorded $17.7 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes.
In addition, we updated our estimate of variable consideration related to the bulk drug product transferred in prior years.
Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items.
−Removed: As a result, during the year ended December 31, 2022, we reclassified a total of $57.4 million from the related deferred revenue to accrued liabilities.
−Removed: As of December 31, 2022, the related balance in accrued liabilities was $57.4 million.
+Added: As a result, for the year ended December 31, 2023, we reclassified $38.7 million from the related deferred revenue to accrued liabilities.
+Added: As of December 31, 2023, the related balance in accrued liabilities was $38.6 million, and we paid $35.3 million to Astellas during the year ended December 31, 2024.
In addition, we recognized royalty revenue of $4.3 million and $2.3 million as drug product revenue from the deferred revenue under the Astellas Europe Agreement for the years ended December 31, 2024 and 2023, respectively.
1 unchanged sentence
AstraZeneca U.S./RoW Agreement
−Removed: There was no shipment of bulk drug product to AstraZeneca as commercial supply under the terms of the AstraZeneca Master Supply Agreement during the years ended December 31, 2023 and 2022.
−Removed: During the first quarter of 2022, we evaluated the current developments in the U.S.
−Removed: market, and updated our estimates of variable consideration associated with bulk drug product shipments to AstraZeneca in prior years as commercial supply under the terms of the AstraZeneca Master Supply Agreement.
−Removed: As a result, during the year ended December 31, 2022, we reclassified $11.2 million from the related deferred revenue to accrued liabilities, which remained unchanged as of December 31, 2023, representing our best estimate that this amount will be paid within the next 12 months.
+Added: 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.
+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, and received the cash during the second quarter of 2024.
+Added: In addition, the related accrued liabilities of $11.2 million as of December 31, 2023 was settled during the second quarter of 2024.
Operating Costs and Expenses
Years Ended December 31,
−Removed: Change 2023 vs.
(dollars in thousands)
5 unchanged sentences
Total operating costs and expenses
−Removed: ________________________
−Removed: NM = Not meaningful
Total operating expenses decreased $189.5 million, or 51% for the year ended December 31, 2024 compared to the year ended December 31, 2023, for the reasons discussed in the sections below.
Cost of goods sold
−Removed: Cost of goods sold decreased ($1.4) million, or (7)% for the year ended December 31, 2023 compared to the year ended December 31, 2022.
−Removed: Cost of goods sold, associated with the roxadustat commercial sales in China, consists of direct costs to manufacture commercial product, as well as indirect costs including factory overhead, storage, shipping, quality assurance, idle capacity charges, and inventory valuation adjustments.
−Removed: Cost of goods sold associated with the roxadustat commercial sales in China was $14.9 million for the year ended December 31, 2023, as compared to $15.1 million for the year ended December 31, 2022, a decrease of $0.2 million, resulting from improved unit cost efficiency primarily due to higher production volume, partially offset by the increase in the sales volume.
+Added: 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: 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.
+Added: Correspondingly, we recorded the related cost of goods sold of $14.6 million during the year ended December 31, 2024.
Cost of goods sold associated with the roxadustat drug product revenue in the U.S.
was $0.8 million and $3.1 million for the years ended December 31, 2024 and 2023, 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, 2023 and 2022 also included manufacturing costs $0.8 million and $1.4 million, respectively, related to our contract manufacturing revenue from Eluminex.
+Added: 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
3 unchanged sentences
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 assets that have no alternative future use other than in a particular research and development project.
−Removed: We have implemented a cost reduction effort since 2021 and efforts to streamline operations to align with our business goals in the second half of 2023, as a result, research and development expenses have decreased and may continue to decrease in certain areas over time.
+Added: 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.
+Added: We have implemented a significant cost reduction plan in the U.S.
+Added: in the third quarter of 2024, and efforts to streamline operations to align with our business goals in the second half of 2023.
+Added: As a result, research and development expenses have overall decreased and may continue to decrease in certain areas over time.
The following table summarizes our research and development expenses incurred during the years ended December 31, 2024 and 2023:
6 unchanged sentences
* 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.
−Removed: See Note 4, Exclusive License and Option to Acquire Fortis Therapeutics , to the consolidated financial statements.
−Removed: ** Other research and development expenses included $60.0 million of acquired in-process research and development assets related to upfront payments to HiFiBiO during the year ended December 31, 2021.
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 $170.8 million, or 64% for the year ended December 31, 2024 compared to the year ended December 31, 2023 as a result of the net effect of the following:
−Removed: • Decrease of $37.8 million in drug development expenses associated with drug substance, drug product manufacturing activities and logistic activities related to pamrevlumab which were largely completed in the prior periods;
−Removed: • Decrease of $9.4 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units;
−Removed: • $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;
−Removed: • Increase of $3.7 million in employee-related costs primarily due to the impact from payroll tax refunds received during 2022 that did not recur in the current year, as well as more business travel activities and higher severance, offset by the impact from reduction in force actions in July 2023;
−Removed: • Increase of $3.1 million information technology, facilities and allocated costs primarily associated with software costs and maintenance services.
+Added: • Decrease of $61.4 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;
+Added: • 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;
+Added: • $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;
+Added: • 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;
+Added: • 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;
+Added: • 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;
+Added: • 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.
Selling, General and Administrative Expenses
Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance, and human resource functions.
−Removed: SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services including co-promotional expenses associated with our commercialization efforts in China, recruiting fees and expenses associated with obtaining and maintaining patents.
−Removed: We have implemented a cost reduction effort since 2021 and efforts to streamline operations to align with our business goals in the second half of 2023, as a result, SG&A expenses have decreased in certain areas and may continue to decrease over time.
+Added: SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents.
+Added: We have implemented a significant cost reduction plan in the U.S.
+Added: in the third quarter of 2024, and efforts to streamline operations to align with our business goals in the second half of 2023.
+Added: As a result, SG&A expenses have overall decreased and may continue to decrease over time.
SG&A expenses decreased $37.2 million, or 43% for the year ended December 31, 2024 compared to the year ended December 31, 2023, as a result of the net effect of the following:
+Added: • 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;
• Decrease of $11.5 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units;
−Removed: • Decrease of $3.8 million in legal expenses primarily due to lower corporate legal activities;
−Removed: • Decrease of $3.3 million due to higher expenses in information technology, facilities and equipment costs primarily associated with software costs and maintenance services, which were allocated to research and development expenses;
−Removed: • Increase of $1.7 million in outside services expenses due to higher consulting activities in general administrative function and efforts to prepare for commercialization in the first half of the year;
−Removed: • Increase of $1.1 million in employee-related costs primarily due to the impact from payroll tax refunds received during 2022 that did not recur in the current year, as well as higher severance during the current year period, offset by the impact from reduction in force actions in July 2023 and lower recruiting and relocation costs.
+Added: • Decrease of $5.4 million in outside services expenses due to cost control efforts;
+Added: • Decrease of $4.3 million in legal expenses primarily due to lower activities in corporate legal, legal proceedings and intellectual properties.
Restructuring Charge
−Removed: On July 14, 2023, we approved a restructuring plan (the “Plan”) to lower our operating expenses.
−Removed: The Plan included a reduction to our U.S.
−Removed: workforce of approximately 32% (or 104 employees).
+Added: In response to the topline clinical results for pamrevlumab in patients with pancreatic cancer we announced in July 2024, we implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously winding down remaining obligations, and reducing our U.S.
+Added: workforce by approximately 75%.
+Added: 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.
+Added: In July 2023, we approved a restructuring plan to lower our operating expenses.
+Added: The restructuring plan included reducing our U.S.
+Added: workforce by approximately 32%.
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.
−Removed: The Plan is in connection with the Company’s efforts to streamline operations to align with the Company’s business goals.
Interest and Other, Net
Years Ended December 31,
−Removed: Change 2023 vs.
(dollars in thousands)
5 unchanged sentences
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 increased $14.1 million, or 979% for the year ended December 31, 2023 compared to the year ended December 31, 2022.
−Removed: Interest expense for the year ended December 31, 2023 included $7.4 million related to the senior secured term loan facilities entered into in April 2023.
−Removed: See Note 9, Senior Secured Term Loan Facilities, to the consolidated financial statements for details.
−Removed: Interest expense for the years ended December 31, 2023 and 2022 also included interest expense of $7.7 million and $1.0 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 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.
See Note 10, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details.
1 unchanged sentence
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.
−Removed: Interest income and other income (expenses), net increased $2.9 million, or 38% for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to $5.8 million higher interest income from our investments with higher interest rate during the current year period, and $2.3 million of favorable foreign exchange impact, partially offset by an impact of $5.0 million recorded during the second quarter of 2022, which did not recur in the current year period, resulting from a reduction to other expenses to release the previously estimated late payment fees related to value added tax in China.
−Removed: Provision for Income Taxes
+Added: Interest income and other income (expenses), net decreased $2.3 million, or 30%, for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily due to lower interest income resulting from lower investment balances.
+Added: Benefit from Income Taxes
Years Ended December 31,
1 unchanged sentence
Loss before income taxes
−Removed: Provision for income taxes
+Added: Benefit from income taxes
Effective tax rate
−Removed: The provisions for income taxes for each of the three years ended December 31, 2023 were due to foreign taxes.
+Added: The provisions for income taxes for each of the two years ended December 31, 2024 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.
We intend to continue maintaining a full valuation allowance on our deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of this allowance.
−Removed: Investment Income (Loss) in Unconsolidated Variable Interest Entity
−Removed: Investment income (loss) in unconsolidated variable interest entity represented our proportionate share of the reported profits or losses of Falikang, an unconsolidated variable interest entity accounted for under the equity method.
−Removed: See Note 5, Equity method investment - Variable Interest Entity , to the consolidated financial statements for details.
+Added: Discontinued Operations
+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: AstraZeneca is our long-time commercialization partner for roxadustat in greater China and South Korea.
+Added: 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.
+Added: 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: 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.
+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.
+Added: See Note 3, Discontinued Operations , 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.
−Removed: On November 4, 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.
+Added: In November 2022, we entered into a RIFA with NovaQuest with respect to our revenues from Astellas’ sales of roxadustat in Europe, Japan and the other Astellas territories.
Pursuant to the RIFA, in the fourth quarter of 2022, we received $49.8 million from NovaQuest, representing the gross proceeds of $50.0 million net of initial issuance costs, in consideration for a portion of future revenues we will receive from Astellas.
For additional details about this financing transaction, see Note 10, Liability Related to Sale of Future Revenues , to the consolidated financial statements.
−Removed: On February 27, 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.
+Added: 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.
(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.
as an additional Sales Agent under that agreement.
−Removed: Under the at-the-market agreement, we may 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 (the “ATM Program”).
−Removed: Under the 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.
+Added: 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.
+Added: 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.
+Added: We did not sell any shares of common stock under this ATM program during the year ended December 31, 2024.
+Added: 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: 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.
See the At-the-Market Program section, in Note 13, Equity and Stock-based Compensation, to the consolidated financial statements for details.
−Removed: On April 29, 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.
+Added: 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.
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.
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, 2023, we had cash and cash equivalents of $113.7 million, compared to $155.7 million as of December 31, 2022.
+Added: 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.
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, 2023, we had short-term investments of $121.9 million, compared to short-term investments of $266.3 million and long-term investments of $4.3 million as of December 31, 2022.
−Removed: As of December 31, 2023, a total of $32.2 million of our cash and cash equivalents was held outside of the U.S.
−Removed: in our foreign subsidiaries, including $32.1 million held in China, to be used primarily for our China operations.
−Removed: Our long-term plans for distributing cash flows from FibroGen Beijing may involve any number of scenarios including keeping the money onshore to fund future expansion of our China operations or paying down certain debt obligations.
+Added: 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.
+Added: 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.
+Added: 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.
During the year ended December 31, 2024, FibroGen Beijing made a total of $49.9 million repayments of intercompany loans.
−Removed: 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: 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.
+Added: 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.
Cash Sources and Uses
−Removed: The following table summarizes the primary sources and uses of cash for the years ended December 31, 2023, 2022 and 2021 (in thousands):
+Added: The following table summarizes the primary sources and uses of cash for the years ended December 31, 2024 and 2023 (in thousands), including both continuing operations and discontinued operations:
Years Ended December 31,
4 unchanged sentences
Effect of exchange rate changes on cash and cash equivalents
−Removed: Net decrease in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
Operating Activities
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.
−Removed: The significant non-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.
+Added: The significant non-cash items included stock-based compensation expense of $25.2 million.
The significant items in the changes in operating assets and liabilities included the following:
−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.
+Added: • Accrued and other liabilities decreased $93.8 million, driven by payment of $35.3 million to Astellas and $11.5 million to AstraZeneca related to accrued API and bulk drug product price true-up, bonus and severance payouts totaling $35.6 million, and settlement of historical co-promotion balances under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca.
+Added: The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment.
+Added: • 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.
+Added: See Note 5, Leases , to the consolidated financial statements for details;
+Added: • 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.
+Added: 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.
See the Drug Product Revenue, Net section in Note 4, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details.
+Added: 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;
+Added: • Prepaid expenses and other current assets increased $15.6 million, primarily due to the unbilled receivables from Falikang based on the arrangements under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, offset by the reimbursements from the insurance for the legal fees associated with the class action lawsuit, which is recoverable under our insurance policies.
+Added: • 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.
+Added: 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: • 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.
+Added: (“WuXi STA”).
+Added: 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;
+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 as discussed above and in Note 3, Discontinued Operations to the consolidated financial statements.
+Added: The increase was offset by timing of invoicing and payments and cost control efforts.
+Added: 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.
+Added: 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.
+Added: The significant items in the changes in operating assets and liabilities included the following:
+Added: • 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.
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: See Note 12, Commitments and Contingencies, to the consolidated financial statements for details.
The accrued and other liabilities were also impacted by the timing of invoicing and payment;
• 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: See the Drug Product Revenue, Net section in Note 3, Collaboration Agreements, License Agreement and Revenues , to the consolidated financial statements for details;
• 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;
• 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.
−Removed: Net cash used in operating activities was $145.9 million for the year ended December 31, 2022 and consisted primarily of net loss of $293.7 million adjusted for non-cash items and non-operating activities of $77.3 million and a net increase in operating assets and liabilities of $70.4 million.
−Removed: The significant non-cash items included stock-based compensation expense of $65.6 million, and depreciation expense of $10.0 million.
−Removed: The significant items in the changes in operating assets and liabilities included the following:
−Removed: • Accrued and other liabilities increased $90.6 million, primarily related to the total of $75.1 million for API and bulk drug product price true-up as of December 31, 2022, 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, and the bulk drug product shipments to AstraZeneca under the terms of the AstraZeneca Master Supply Agreement.
−Removed: The accrued and other liabilities were also impacted by the classification of a portion of accrued co-promotion expenses from other long-term liabilities to current liabilities based on the updated estimate of timing for payment, and by the timing of invoicing and payment;
−Removed: • Accounts payable increased $5.9 million, primarily driven by the timing of invoicing and payments;
−Removed: • Prepaid expenses and other current assets decreased $4.9 million, primarily due to the collection of $8.0 million from Eluminex for upfront license payment during the first quarter of 2022, and less prepayments made for roxadustat API manufacturing activities, partially offset by a payroll tax refund recorded as other receivables as of December 31, 2022 and received in the first quarter of 2023;
−Removed: • Other long-term liabilities decreased $18.3 million primarily driven by the above-mentioned classification of a portion of accrued co-promotion expenses from other long-term liabilities to current liabilities based on the updated estimate of timing for payment;
−Removed: • Inventories increased $11.0 million, driven by the increased inventory level primarily related to inventory cost capitalized related to Europe and other territories, and FibroGen Beijing’s productions of roxadustat for commercial sales purposes;
−Removed: • Deferred revenue decreased $4.1 million, primarily related to revenue recognized from the previously deferred revenue of the China performance obligation during the year ended December 31, 2022, and the above-mentioned reclassification to accrued liabilities, resulting from changes in estimated variable consideration associated with the API or bulk drug product deliveries fulfilled with Astellas and AstraZeneca.
Investing Activities
−Removed: Investing activities primarily consist of purchases of property and equipment, purchases of investments, purchase of acquired in-process research and development asset and proceeds from the maturity and sale of investments.
+Added: 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: 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.
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.
−Removed: Net cash provided by investing activities was $89.1 million for the year ended December 31, 2022 and consisted primarily of $284.5 million of proceeds from maturities of investments and $7.4 million of proceeds from sales of available-for-sale securities, partially offset by $164.0 million of cash used in purchases of available-for-sale securities, $35.0 million of cash paid for the acquired in-process research and development asset and $3.7 million of cash used in purchases of property and equipment.
Financing Activities
−Removed: Financing activities primarily reflect proceeds from strategic financing arrangements, proceeds from the issuance of our common stock, cash paid for payroll taxes on restricted stock unit releases, and repayments of our lease liabilities and obligations.
−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 (“ESPP”).
−Removed: Net cash provided by financing activities was $46.8 million for the year ended December 31, 2022 and consisted primarily of $49.8 million of net proceeds from sale of future revenues from NovaQuest, $4.2 million of proceeds from the issuance of common stock upon exercise of stock options and purchases under our ESPP, partially offset by $5.2 million of cash paid for payroll taxes on restricted stock unit releases, and $1.5 million of cash paid for transaction costs related to sale of future revenues.
+Added: 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 not material for the year ended December 31, 2024.
+Added: 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
We generate revenue from commercial sales of roxadustat product in China, Japan and Europe.
−Removed: Even with the expectation of increases in these revenues, we anticipate that we will continue to generate losses for the foreseeable future.
+Added: 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.
To date, we have funded certain portions of our research and development and manufacturing efforts globally through collaboration partners, debt financings, and equity financing.
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We anticipate that we will need substantial additional funding in connection with our continuing operations.
−Removed: We believe that our existing cash and cash equivalents, short-term investments and accounts receivable, together with the proceeds from senior secured term loan facilities in the second quarter of 2023, the financing amount under the RIFA received in fourth quarter of 2022, and the net proceeds received under our ATM program in the first half of 2023, as well as the cost savings we have recently implemented (including from the reduction in workforce that we announced on July 19, 2023), will be sufficient to meet our anticipated cash requirements for at least the next 12 months from the date of issuance of the financial statements included in this Annual Report.
−Removed: However, we may need additional capital thereafter and our liquidity assumptions may materially differ and we could utilize our available financial resources sooner than we currently expect.
−Removed: We may incur additional expenses not currently contemplated due to events associated with the recently announced reduction in workforce.
−Removed: In addition, we may elect to raise additional funds at any time through equity, equity-linked, debt financing arrangements or from other sources.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Upon an event of default, our senior secured term loan facilities could become immediately due and payable.
+Added: 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.
+Added: There is also the potential that we raise additional funds in the U.S.
+Added: at any time through equity, equity-linked, or debt financing arrangements or from other sources.
+Added: There can be no assurances that these plans will be successful.
+Added: 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.
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.
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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 needed additional funds, we will have to reduce our operating costs and expenses, which would impair our growth prospects and could otherwise negatively impact our business.
+Added: 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
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Beyond 12 Months
−Removed: Lease liabilities
Purchase obligations
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Total payments
−Removed: Our lease liabilities are primarily related to our real estate leases for office spaces in the U.S.
−Removed: See Note 7, Leases , to the consolidated financial statements for details.
−Removed: Our outstanding non-cancelable purchase obligations primarily related to manufacturing and supply for pamrevlumab and roxadustat, and other purchases and programs.
+Added: Our outstanding non-cancelable purchase obligations primarily related to manufacturing and supply for FG-3246 and roxadustat, and other purchases and programs.
See Note 12, Commitments and Contingencies , to the consolidated financial statements for details.
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See Note 10, Liability Related to Sale of Future Revenues , to the consolidated financial statements for details.
−Removed: Some of our license agreements provide for periodic maintenance fees over specified time periods, as well as payments by us upon the achievement of development, regulatory and commercial milestones.
−Removed: As of December 31, 2023, future milestone payments for research and preclinical stage development programs consisted of up to approximately $697.9 million in total potential future milestone payments under our license agreements with HiFiBiO (for Gal-9 and CCR8), Medarex, Inc.
−Removed: These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones.
−Removed: The event triggering such payment or obligation has not yet occurred and therefore these amounts have been excluded from the table above.
The table above excludes uncertain tax benefits of approximately $74.3 million that are disclosed in Note 15, Income Taxes , to the consolidated financial statements because these uncertain tax positions, if recognized, would be an adjustment to the gross deferred tax assets and the corresponding valuation allowance, if warranted.
As of December 31, 2024, we have several on-going clinical studies in various stages.
−Removed: Under agreements with various CROs, and clinical study sites, we incur expenses related to clinical studies of our product candidates and potential other clinical candidates.
+Added: Under agreements with various contract research organizations (“CROs”), and clinical study sites, we incur expenses related to clinical studies of our product candidates and potential other clinical candidates.
The timing and amounts of these disbursements are contingent upon the achievement of certain milestones, patient enrollment and services rendered or as expenses are incurred by the CROs or clinical trial sites.
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The maximum potential amount of future payments we could be required to make under these arrangements is not determinable.
−Removed: Recently Issued Accounting Guidance Not Yet Adopted
+Added: Recently Issued Accounting Guidance
For recently issued accounting guidance, see Note 2, Significant Accounting Policies, to the consolidated financial statements.
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Actual results may differ from these estimates under different assumptions or conditions.
−Removed: While our significant accounting policies are described in more detail in the notes to our financial statements appearing elsewhere in this Annual Report, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements.
+Added: While our significant accounting policies and critical estimates are described in more detail in the notes to our financial statements appearing elsewhere in this Annual Report, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements.
Revenue Recognition
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We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
−Removed: Product revenue, net
−Removed: Product revenue, net consists of revenues from sales of roxadustat commercial product to Falikang, and directly to pharmaceutical distributors located in one province in China that are not covered by Falikang.
+Added: Drug product revenue
+Added: 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: We recognize drug product revenue when we fulfill the inventory transfer obligations.
+Added: The amount of variable consideration that is included in the transaction price may be constrained, and we include it in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved.
+Added: Estimating variable consideration and the related constraint requires the use of significant management judgment.
+Added: We review new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material.
+Added: Actual amounts of consideration ultimately received in the future may differ from our estimates, for which we will adjust these estimates and affect the drug product revenue in the period such variances become known.
+Added: 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.
+Added: China performance obligation
+Added: Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.
Falikang is jointly owned by AstraZeneca and FibroGen Beijing.
−Removed: We are not the primary beneficiary of Falikang for accounting purposes, as AstraZeneca is the final decision maker for all the roxadustat commercialization activities, and we lack the power criterion to direct the activities of Falikang (see Note 5, Equity method investment - Variable Interest Entity, to our consolidated financial statements).
−Removed: Sales to Falikang
−Removed: Falikang became fully operational in January 2021, at which time FibroGen Beijing began selling roxadustat commercial product to Falikang.
Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang.
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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: Direct Sales to Distributors
−Removed: We sell roxadustat in China directly to a number of pharmaceutical distributors located in one province in China that are not covered by Falikang.
−Removed: These pharmaceutical distributors are our customers.
−Removed: Hospitals order roxadustat through a distributor and we ship the product directly to the distributors.
−Removed: The delivery of roxadustat to a distributor represents a single performance obligation.
−Removed: Distributors are responsible for delivering product to end users, primarily hospitals.
−Removed: Distributors bear inventory risk once they receive and accept the product.
−Removed: We recognize product 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.
−Removed: The period between the transfer of control of the promised goods and when we receive payment is based on 60-day payment terms.
−Removed: As such, we do not adjust product revenue for the effects of a significant financing component.
−Removed: We record product revenue at the net sales prices that includes certain estimates of variable consideration.
−Removed: These estimates include price adjustment calculated based on estimated channel inventory levels when China’s National Healthcare Security Administration releases price guidance for roxadustat under the National Reimbursement Drug List, various fixed-amount or percentage-based rebates and discounts recorded as a reduction to revenue at the point of sale to the distributor or when distributor meets eligibility requirements, and estimated sales return as distributors can request to return product to us only due to quality issues or for product purchased within one year prior to the product’s expiration date.
−Removed: We calculate the variable consideration based on gross sales to the distributor, or estimate it utilizing best available information from the distributor, maximum known exposures and other available information including estimated channel inventory levels and estimated sales made by the distributor to hospitals, which involves significant judgment.
−Removed: The rebates and discounts all together are eligible to be applied against the distributor’s future sales order, limited to certain maximums until such rebates and discounts are exhausted.
−Removed: We record these rebates and discounts as contract liabilities at the time they become eligible and in the same period that the related revenue is recorded.
−Removed: Due to our legal right to offset, at each balance sheet date, we present the rebates and discounts as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when we expect to settle the discount in cash.
−Removed: We calculate the distributor’s legal right of offset at the individual distributor level.
−Removed: 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.
−Removed: We recognize drug product revenue when we fulfill the inventory transfer obligations.
−Removed: The amount of variable consideration that is included in the transaction price may be constrained, and we include it in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: Estimating variable consideration and the related constraint requires the use of significant management judgment.
−Removed: We review new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material.
−Removed: Actual amounts of consideration ultimately received in the future may differ from our estimates, for which we will adjust these estimates and affect the drug product revenue in the period such variances become known.
−Removed: 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.
+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 will be satisfied upon the closing of the divestiture FibroGen International.
+Added: The product revenue recognized under the China performance obligation is included in discontinued operations for all periods presented.
+Added: Discontinued Operations
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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: 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.
+Added: 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.
+Added: 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.
+Added: 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 , to our consolidated financial statements for related disclosures.
QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISKS
−Removed: We are exposed to market risk in the ordinary course of our business.
−Removed: Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates.
−Removed: Our market risk exposure is primarily a result of fluctuations in foreign currency exchange rates.
−Removed: Currently, the functional currency of our subsidiaries, FibroGen Europe Oy and FibroGen Beijing, is the local currency.
−Removed: Our consolidated results of operations are reported in U.S.
−Removed: Our revenues and operating costs and expenses are denominated in the currencies of the countries in which our operations are located, which are primarily in the U.S.
−Removed: Therefore, our consolidated results of operations and cash flows are subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange rates.
−Removed: As of December 31, 2023, we did not have material financial assets and liabilities denominated in foreign currencies that are subject to fluctuation in the exchange rate with the U.S.
−Removed: Therefore, our financial assets and liabilities are not currently subject to significant foreign currency risk.
−Removed: The primary objective of our investment activities is to preserve our capital to fund our operations.
−Removed: We also seek to maximize income from our cash and cash equivalents without assuming significant risk.
−Removed: To achieve our objectives, we invest our non-operating cash and cash equivalents primarily in commercial paper and money market funds as of December 31, 2023.
−Removed: Given the nature of our investments as of December 31, 2023, we believe that our exposure to interest rate risk is not significant.
−Removed: We actively monitor changes in interest rates.
−Removed: To date, we have not entered into any hedging arrangements with respect to foreign currency risk or other derivative financial instruments.
+Added: We are a smaller reporting company as defined in Rule 12b-2 of the Exchange Act;
+Added: therefore, pursuant to Item 305(e) of Regulation S-K, we are not required to provide the information required by this Item.
CONSOLIDATED FINANCIAL ST ATEMENTS AND SUPPLEMENTARY DATA
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Consolidated Statements of Comprehensive Loss
−Removed: Consolidated Statements of Changes in Stockholders’ Equity (Deficit )
+Added: Consolidated Statements of Changes in Redeemable Non-controlling Interests and Stockholders’ Deficit
Consolidated Statements of Cash Flows
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Financial Statement Schedule:
−Removed: II Valuation and Qualifying Accounts for each of the three years ended December 31, 2023
+Added: Valuation and Qualifying Accounts for each of the two years ended December 31, 2024
Report of Independent Regis tered Public Accounting Firm
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We have audited the accompanying consolidated balance sheets of FibroGen, Inc.
−Removed: and its subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations, of comprehensive loss, of changes in stockholders’ equity (deficit) and of cash flows for each of the three years in the period ended December 31, 2023, including the related notes and financial statement schedule listed in the accompanying index (collectively referred to as the “consolidated financial statements”).
+Added: 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").
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, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023 in conformity with accounting principles generally accepted in the United States of America.
+Added: 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.
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.
+Added: Substantial Doubt About the Company's Ability to Continue as a Going Concern
+Added: The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: 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.
+Added: These conditions raise substantial doubt about its ability to continue as a going concern.
+Added: Management's plans in regard to these matters are also described in Note 2.
+Added: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinions
21 unchanged sentences
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., Ltd.
+Added: Determining the Transaction Price for Product Revenue Recognition for Sales to Beijing Falikang Pharmaceutical Co.
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.
9 unchanged sentences
/s/ PricewaterhouseCoopers LLP
−Removed: San Jose, California
−Removed: February 26, 2024
+Added: Irvine, California
+Added: March 17, 2025
We have served as the Company’s auditor since 2000.
7 unchanged sentences
Short-term investments
−Removed: Accounts receivable, net ($ 6,079 and $ 12,088 from related parties)
+Added: Accounts receivable, net
Prepaid expenses and other current assets
+Added: Current assets held for sale
Total current assets
Restricted time deposits
−Removed: Long-term investments
Property and equipment, net
−Removed: Equity method investment in unconsolidated variable interest entity
Operating lease right-of-use assets
+Added: Long-term assets held for sale
Liabilities, redeemable non-controlling interests and deficit
1 unchanged sentence
Accounts payable
−Removed: Accrued and other current liabilities ($ 39,814 and $ 63,886 to a related party)
−Removed: Deferred revenue ($ 7,220 and $ 9,259 to related parties)
+Added: Accrued and other current liabilities
+Added: Deferred revenue
Operating lease liabilities, current
+Added: Current liabilities held for sale
Total current liabilities
Product development obligations
−Removed: Deferred revenue, net of current ($ 9,705 and $ 31,044 to a related party)
+Added: Deferred revenue, net of current
Operating lease liabilities, non-current
1 unchanged sentence
Liability related to sale of future revenues, non-current
−Removed: Other long-term liabilities ($ 656 and $ 0 to a related party)
+Added: Other long-term liabilities
+Added: Long-term liabilities held for sale
Total liabilities
23 unchanged sentences
Years Ended December 31,
−Removed: License revenue (includes $ 0 , $ 22,590 and $ 108,434
−Removed: from a related party)
−Removed: Development and other revenue (includes $ 6,662 , $ 9,908 and $ 21,928 from a related party)
−Removed: Product revenue, net (includes $ 89,055 , $ 71,167 and $ 35,568
−Removed: from a related party)
−Removed: Drug product revenue, net (includes $ 18,753 , $ 11,086 and $ 3,186
−Removed: from a related party)
+Added: License revenue
+Added: Development and other revenue
+Added: Drug product revenue, net
Total revenue
10 unchanged sentences
Total interest and other, net
−Removed: Loss before income taxes
−Removed: Provision for income taxes
−Removed: Investment income in unconsolidated variable
−Removed: interest entity
+Added: Loss from continuing operations before income taxes
+Added: Benefit from income taxes
+Added: Loss from continuing operations
+Added: Income from discontinued operations, net of tax
+Added: Loss from continuing operations per share - basic and diluted
+Added: Income from discontinued operations per share - basic and diluted
Net loss per share - basic and diluted
14 unchanged sentences
FIBROGEN, INC.
−Removed: CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
+Added: CONSOLIDATED STATEMENTS OF CHANGES IN redeemable non-controlling interests
+Added: AND STOCKHOLDERS’ DEFICIT
(In thousands, except share data)
1 unchanged sentence
Non-Controlling
−Removed: Equity (Deficit)
December 31, 2022
−Removed: Change in unrealized
−Removed: gain or loss on
−Removed: Foreign currency
−Removed: Shares issued from
−Removed: stock plans, net of
−Removed: payroll taxes paid
−Removed: Conversion of
−Removed: December 31, 2021
+Added: Consolidation of Fortis
Change in unrealized
1 unchanged sentence
Foreign currency
+Added: Issuance of common
+Added: stock under ATM
Shares issued from
2 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
11 unchanged sentences
Net accretion of premium and discount on investments
−Removed: Unrealized loss on equity investments
Investment income in unconsolidated variable interest entity
−Removed: Loss (gain) on disposal of property and equipment
+Added: Loss on disposal of property and equipment
Stock-based compensation
5 unchanged sentences
Changes in operating assets and liabilities:
−Removed: Accounts receivable, net ($ 6,009 , $( 1,158 ) and $( 6,803 ) from related parties)
−Removed: Prepaid expenses and other current assets ($ 0 , $ 0 and $ 889 from a related party)
+Added: Accounts receivable, net
+Added: Prepaid expenses and other current assets
Operating lease right-of-use assets
−Removed: Accounts payable ($ 0 , $ 0 and $( 1,118 ) from a related party)
−Removed: Accrued and other liabilities ($( 24,072 ), $ 63,882 and $( 20 ) from a related party)
+Added: Accounts payable
+Added: Accrued and other liabilities
Operating lease liabilities, current
−Removed: Deferred revenue ($( 23,378 ), $ 11,211 and $ 21,549 from related parties)
+Added: Deferred revenues
+Added: Accrued interest expense related to sale of future revenues
Accrued interest for finance lease liabilities
4 unchanged sentences
Purchases of property and equipment
−Removed: Payment made for acquired in-process research and development asset
Proceeds from sale of property and equipment
3 unchanged sentences
Proceeds from maturities of investments
−Removed: Net cash provided by (used in) investing activities
+Added: Net cash provided by investing activities
Financing activities
4 unchanged sentences
Cash paid for payroll taxes on restricted stock unit releases
−Removed: Proceeds from sale of future revenues, net of issuance costs
−Removed: Cash paid for transaction costs related to sale of future revenues
Proceeds from issuance of common stock under ATM Program, net of commissions
Proceeds from issuance of common stock under employee stock plans
−Removed: Net cash provided by (used in) financing activities
+Added: Net cash (used in) provided by financing activities
Effect of exchange rate change on cash and cash equivalents
−Removed: Net decrease in cash and cash equivalents
+Added: Net increase (decrease) in cash and cash equivalents
Total cash and cash equivalents at beginning of period
5 unchanged sentences
of property and equipment
−Removed: Balance in accrued liabilities related to issuance costs of secured term loan facilities
−Removed: Balance in other receivables related to stock option exercise
−Removed: Conversion of subsidiary’s convertible note payable to non-controlling interests
+Added: Reconciliation of cash and cash equivalents to the consolidated balance sheets:
+Added: December 31, 2024
+Added: December 31, 2023
+Added: Cash and cash equivalents of continuing operations
+Added: Cash and cash equivalents included in assets held for sale
+Added: Total cash and cash equivalents in the consolidated statements of cash flows
The accompanying notes are an integral part of these Consolidated Financial Statements.
2 unchanged sentences
FibroGen, Inc.
−Removed: (“FibroGen” or the “Company”) is headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China (“China”).
−Removed: FibroGen is developing and commercializing a diversified pipeline of novel therapeutics that work at the frontier of cancer biology and anemia.
−Removed: Pamrevlumab, a human monoclonal antibody targeting connective tissue growth factor, is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer.
−Removed: Pamrevlumab is also in Phase 2/3 development for the treatment of metastatic pancreatic cancer.
−Removed: To date, the Company has retained exclusive worldwide rights for pamrevlumab.
−Removed: Roxadustat is an oral small molecule inhibitor of HIF prolyl hydroxylase activity.
−Removed: Roxadustat (爱瑞卓 ® , EVRENZO TM ) is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) for patients who are on dialysis and not on dialysis.
−Removed: Roxadustat is in clinical development for chemotherapy-induced anemia in China.
−Removed: FibroGen is also developing earlier stage clinical and preclinical product candidates, FG-3246, FG-3165 and FG-3175, to address unmet patient needs in oncology.
+Added: (“FibroGen” or the “Company”) is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia.
+Added: 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: This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent.
+Added: 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.
+Added: 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.
+Added: agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd.
+Added: (“FibroGen International”) to AstraZeneca Treasury Limited.
+Added: AstraZeneca AB (“AstraZeneca”) is the Company’s long-time commercialization partner for roxadustat in greater China and South Korea.
+Added: 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.
+Added: Ltd (“Falikang”).
+Added: 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: 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: (“Astellas”).
+Added: Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements:
+Added: one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.
+Added: 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.
Summary of Significant Accounting Policies
3 unchanged sentences
All inter-company transactions and balances have been eliminated in consolidation.
−Removed: For any VIE for which FibroGen is not the primary beneficiary, the Company uses the equity method of accounting.
The Company operates in one reportable segment — the development and commercialization of novel therapeutics to treat serious unmet medical needs.
−Removed: The Company believes that its existing cash and cash equivalents, short-term investments and accounts receivable will be sufficient to meet its anticipated cash requirements for at least the next 12 months from the date of issuance of the financial statements.
−Removed: However, the Company may need additional capital thereafter and its liquidity assumptions may materially differ.
−Removed: The Company may utilize its available financial resources sooner than it currently expects and may incur additional expenses not currently contemplated.
−Removed: In addition, the Company may elect to raise additional funds at any time through equity, equity-linked, debt financing arrangements or from other sources.
+Added: Discontinued Operations
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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: 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.
+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 Boards (“FASB”) Accounting Standards Codification (“ASC”) 205, Presentation of Financial Statements , as of December 31, 2024.
+Added: 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.
+Added: 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 , for related disclosures.
+Added: Unless otherwise noted, discussion in the notes to these consolidated financial statements, relates to solely to the Company’s continuing operations.
+Added: Liquidity and Going Concern
+Added: The consolidated financial statements are prepared in accordance with the U.S.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Upon an event of default, the Company’s senior secured term loan facilities could become immediately due and payable.
+Added: 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.
+Added: There is also the potential that the Company raises additional funds in the U.S.
+Added: at any time through equity, equity-linked, or debt financing arrangements or from other sources.
+Added: There can be no assurances that these plans will be successful.
+Added: 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.
Foreign Currency Translation
21 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, the majority of cash on hand is invested in U.S.
−Removed: treasuries, corporate bonds, commercial paper and money market funds.
−Removed: Any remaining cash is deposited with major financial institutions primarily in the U.S., China and the Cayman Islands.
+Added: Outside of short-term operating needs, cash on hand is invested in commercial paper and money market funds.
+Added: Any remaining cash is deposited with major financial institutions primarily in the U.S.
At times, such deposits may be in excess of insured limits.
The Company has not experienced any loss on its deposits of cash and cash equivalents.
−Removed: Included in current assets are significant balances of accounts receivable as follows:
−Removed: Falikang — Related party
−Removed: As of December 31, 2023 and 2022 , the aggregate accounts receivable related to roxadustat sales in China from distributors represented 17 % and 10 %, respectively, of the consolidated accounts receivable, with no material balance from any individual distributor.
+Added: As of December 31, 2024 and 2023 , the accounts receivable was not material.
Other Risks and Uncertainties
1 unchanged sentence
Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, the results of clinical trials and the achievement of milestones, research developments, actions by regulatory authorities, market acceptance of the Company’s product candidates, competition from other products and larger companies, the liquidity and capital resources of the Company, intellectual property protection for the Company's proprietary technology, strategic relationships, and dependence on key individuals, suppliers, clinical organization, and other third parties.
−Removed: Cash, Cash Equivalents and Restricted Time Deposits
+Added: Cash, Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents.
−Removed: Cash and cash equivalents also include money market accounts and various deposit accounts.
−Removed: As of December 31, 2023 and 2022, a total of $ 32.2 million and $ 92.5 million , respectively, of the Company’s cash and cash equivalents was held outside of the U.S.
−Removed: in the Company’s foreign subsidiaries to be used primarily for the Company’s China operations.
−Removed: Restricted time deposits include an irrevocable standby letter of credit as security deposit for a long-term property lease with the Company’s landlord.
−Removed: Restricted time deposits were $ 1.7 million and $ 2.1 million as of December 31, 2023 and 2022 , respectively.
−Removed: As of December 31, 2023 , the Company’s investments consist primarily of diversified bonds, commercial paper, and money market funds.
−Removed: Those investments with original maturities of greater than three months and remaining maturities of less than 12 months (365 days) are considered short-term investments.
−Removed: Those investments with maturities greater than 12 months (365 days) from the balance sheet date are considered long-term investments.
+Added: Cash and cash equivalents also include certain money market accounts and commercial paper.
+Added: The Company did no t have any short-term or long-term investments as of December 31, 2024.
+Added: As of December 31, 2023 , 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.
+Added: Any investments with maturities greater than 12 months (365 days) from the balance sheet date are considered long-term investments.
When such investments are held, the Company’s investments classified as available-for-sale are recorded at fair value based upon quoted market prices at period end.
8 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 December 31, 2023, 2022 and 2021 and the allowance for credit losses as of December 31, 2023 and 2022 were immaterial.
+Added: 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.
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.
+Added: 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.
−Removed: The cost of the Company’s inventories in China is determined using full absorption and standard costing method.
−Removed: The Company reviews the standard cost of raw materials, work-in-process and finished goods annually and more often as appropriate to ensure that its inventories approximate current actual cost.
−Removed: The cost of the Company’s inventories in the U.S.
−Removed: uses actual costs to determine its cost basis.
+Added: The Company’s inventories uses actual costs to determine its cost basis.
The cost of inventories includes direct material cost, direct labor and manufacturing overhead.
9 unchanged sentences
Leasehold improvements are recorded at cost and amortized over the term of the lease or their useful life, whichever is shorter.
−Removed: Equity method investment - Variable Interest Entity
+Added: The Company did no t have property and equipment as of December 31, 2024.
+Added: Variable Interest Entity
Under the Accounting Standards Codification (“ASC”) 810, Consolidation (“ASC 810”), when the Company obtains an economic interest in an entity, it evaluates the entity to determine if it should be deemed a VIE, and, if so, whether the Company is the primary beneficiary and is therefore required to consolidate the VIE, based on significant judgment whether the Company (i) has the power to direct the activities that most significantly impact the economic performance of the VIE and (ii) has the obligation to absorb losses or the right to receive benefits of the VIE that could potentially be significant to the VIE.
14 unchanged sentences
the lease costs and interest expenses related to lease liability accretion are remeasured using average exchange rates for the reporting period.
−Removed: Finance leases are included in finance lease ROU assets, finance lease liabilities, current and non-current on the Company’s consolidated balance sheets.
Operating leases are included in operating lease ROU assets, operating lease liabilities, current and non-current on the Company’s consolidated balance sheets.
+Added: As of December 31, 2024, the Company did no t have any operating leases.
+Added: 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.
Impairment of Long-Lived Assets
50 unchanged sentences
For arrangements that include sales-based royalties and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
−Removed: To date, royalty revenue resulting from its collaboration arrangements was immaterial.
The transaction price is allocated to performance obligations based on their relative standalone selling price (“SSP”), with the exception of co-development billings allocated entirely to co-development services performance obligations.
12 unchanged sentences
The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
−Removed: Product revenue, net
−Removed: Product revenue, net consists of revenues from sales of roxadustat commercial product to Falikang, and directly to pharmaceutical distributors located in one province in China that are not covered by Falikang.
−Removed: Falikang is jointly owned by AstraZeneca AB (“AstraZeneca”) and FibroGen Beijing.
−Removed: The Company is not the primary beneficiary of Falikang for accounting purposes, as AstraZeneca is the final decision maker for all the roxadustat commercialization activities, and the Company lacks the power criterion to direct the activities of Falikang (see Note 5, Equity method investment - Variable Interest Entity ).
−Removed: Sales to Falikang
−Removed: Falikang became fully operational in January 2021, at which time FibroGen Beijing began selling roxadustat commercial product to Falikang.
+Added: Drug product revenue
+Added: Drug product revenue includes commercial-grade API or bulk drug product sales to AstraZeneca and Astellas in support of pre-commercial preparation prior to the New Drug Application (“NDA”) or Marketing Authorization Application approval, and to Astellas for ongoing commercial activities in Japan and Europe.
+Added: Drug product revenue is recognized when the Company fulfills the inventory transfer obligations.
+Added: The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved.
+Added: Estimating variable consideration and the related constraint requires the use of significant management judgment.
+Added: The Company reviews new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material.
+Added: Actual amounts of consideration ultimately received in the future may differ from the Company’s estimates, for which the Company will adjust these estimates and affect the drug product revenue in the period such variances become known.
+Added: As each of the Company’s collaboration agreements provide for annual true up to the considerations paid for its commercial supplies, the Company will re-evaluate the transaction price in each reporting period and record adjustment to revenue as uncertain events are resolved or other changes in circumstances occur.
+Added: China performance obligation
+Added: Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.
+Added: Falikang is jointly owned by AstraZeneca and FibroGen Beijing.
Falikang is FibroGen Beijing’s primary customer in China and substantially all roxadustat product sales to distributors in China are made by Falikang.
2 unchanged sentences
Amounts of the transaction price allocable to this performance obligation under the Company’s agreements with AstraZeneca as outlined in Note 4, Collaboration Agreements, License Agreement and Revenues, are deferred until control of the manufactured commercial product is transferred to AstraZeneca.
−Removed: The initiation of roxadustat sales to Falikang marked the beginning of the China performance obligation .
+Added: The initiation of roxadustat sales to Falikang marks the beginning of the China performance obligation .
Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang.
18 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: Direct Sales to Distributors
−Removed: The Company sells roxadustat in China directly to a number of pharmaceutical distributors located in one province in China that are not covered by Falikang.
−Removed: These pharmaceutical distributors are the Company’s customers.
−Removed: Hospitals order roxadustat through a distributor and the Company ships the product directly to the distributors.
−Removed: The delivery of roxadustat to a distributor represents a single performance obligation.
−Removed: Distributors are responsible for delivering product to end users, primarily hospitals.
−Removed: Distributors bear inventory risk once they receive and accept the product.
−Removed: Product revenue is recognized when control of the promised good is transferred to the customer in an amount that reflects the consideration that the Company expects to be entitled to in exchange for the product.
−Removed: The period between the transfer of control of the promised goods and when the Company receives payment is based on 60-day payment terms.
−Removed: As such, product revenue is not adjusted for the effects of a significant financing component.
−Removed: Product revenue is recorded at the net sales prices that includes certain estimates of variable consideration.
−Removed: These estimates include price adjustment calculated based on estimated channel inventory levels when China’s National Healthcare Security Administration releases price guidance for roxadustat under the National Reimbursement Drug List, various fixed-amount or percentage-based rebates and discounts recorded as a reduction to revenue at the point of sale to the distributor or when distributor meets eligibility requirements, and estimated sales return as d i stributors can request to return product to the Company only due to quality issues or for product purchased within one year prior to the product’s expiration date.
−Removed: The calculation of the variable consideration is based on gross sales to the distributor, or estimated utilizing best available information from the distributor, maximum known exposures and other available information including estimated channel inventory levels and estimated sales made by the distributor to hospitals, which involve a significant judgment.
−Removed: The rebates and discounts all together are eligible to be applied against the distributor’s future sales order, limited to certain maximums until such rebates and discounts are exhausted.
−Removed: These rebates and discounts are recorded as contract liabilities at the time they become eligible and in the same period that the related revenue is recorded.
−Removed: Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash.
−Removed: The Company’s legal right to offset is determined at the individual distributor level.
−Removed: The contract liabilities were included in accrued and other current liabilities in the consolidated balance sheet.
−Removed: The rebates and discounts reflected as reductions to gross accounts receivable for direct sales.
−Removed: Drug product revenue
−Removed: Drug product revenue includes commercial-grade API or bulk drug product sales to AstraZeneca and Astellas Pharma Inc.
−Removed: (“Astellas”) in support of pre-commercial preparation prior to the New Drug Application (“NDA”) or Marketing Authorization Application approval, and to Astellas for ongoing commercial activities in Japan and Europe.
−Removed: Drug product revenue is recognized when the Company fulfills the inventory transfer obligations.
−Removed: The amount of variable consideration that is included in the transaction price may be constrained, and is included in the drug product revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: Estimating variable consideration and the related constraint requires the use of significant management judgment.
−Removed: The Company reviews new information that may affect its variable consideration estimate at every reporting period and records revenue adjustment, if certain and material.
−Removed: Actual amounts of consideration ultimately received in the future may differ from the Company’s estimates, for which the Company will adjust these estimates and affect the drug product revenue in the period such variances become known.
−Removed: As each of the Company’s collaboration agreements provide for annual true up to the considerations paid for its commercial supplies, the Company will re-evaluate the transaction price in each reporting period and record adjustment to revenue as uncertain events are resolved or other changes in circumstances occur.
−Removed: License Acquisition Agreement
−Removed: In June 2021, the Company entered into an exclusive license and option agreement (the “HiFiBiO Agreement”) with HiFiBiO Therapeutics (“HiFiBiO”), pursuant to which the Company exclusively licensed all product candidates in HiFiBiO’s Galectin-9 program and subsequently exclusively licensed all product candidates in HiFiBiO’s CCR8 program in December 2021.
−Removed: Under the terms of the HiFiBiO Agreement, the Company has paid a $ 25.0 million upfront payment to HiFiBiO during the year ended December 31, 2021, and recorded a $ 35.0 million upfront payment for the CCR8 option exercise in accrued liabilities as of December 31, 2021, which was paid during the first quarter of 2022.
−Removed: HiFiBiO may receive R&D and regulatory milestone payments of up to $ 175 million, as well as sales milestones of up to $ 170 million.
−Removed: HiFiBiO will also be eligible to receive tiered royalties based upon worldwide net sales capped at 10 %, subject to certain reductions.
−Removed: We expect to file INDs on product candidates for both the CCR8 and Galectin-9 programs in the first half of 2024.
−Removed: The acquisition of these licenses was accounted for as an asset acquisition.
−Removed: The above-mentioned upfront payments of $ 60.0 million related to the license and options acquisition meets the definition of an in-process research and development asset (“IPR&D asset”) under the ASC 730, Research and Development .
−Removed: They relate to particular research and development projects and are determined to have no alternative future uses and thus have no separate economic value.
−Removed: Therefore, these upfront payments were recorded as research and development expenses during the year ended December 31, 2021, and the cash payments were reflected as investing activities in the consolidated statement of cash flows during the years ended December 31, 2022 and 2021, respectively.
−Removed: Contingent consideration payments will be evaluated and recognized when they become probable and reasonably estimable.
−Removed: The related IPR&D asset will only be capitalized if it has an alternative future use other than in a particular research and development project.
−Removed: Otherwise, amounts allocated to IPR&D asset that have no alternative use will be expensed.
−Removed: As of December 31, 2023 , the contingencies related to the milestone payments had not been resolved, therefore no contingent consideration was recognized.
−Removed: The Company will reassess the probability of future option payments and contingent payments on a quarterly basis.
+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 will be satisfied upon the closing of the divestiture FibroGen International (see Discontinued Operations section above).
+Added: The product revenue recognized under the China performance obligation is included in discontinued operations for all periods presented.
Research and Development Expenses
8 unchanged sentences
Selling, general and administrative (“SG&A”) expenses consist primarily of employee-related expenses for executive, operational, finance, legal, compliance and human resource functions.
−Removed: SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services including co-promotional expenses associated with our commercialization efforts in China, recruiting fees and expenses associated with obtaining and maintaining patents.
+Added: SG&A expenses also include facility-related costs, professional fees, accounting and legal services, other outside services, recruiting fees and expenses associated with obtaining and maintaining patents.
Restructuring Charge
16 unchanged sentences
The determination of the grant date fair value of options using the Black-Scholes valuation model is affected by the Company’s estimated common stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends.
−Removed: The Company determines the fair value of RSUs and PRSUs using the fair value of our common stock on the date of grant.
+Added: The Company determines the fair value of RSUs and PRSUs using the fair value of its common stock on the date of grant.
To estimate the fair value of the TSR awards, the Company uses the Monte Carlo valuation model to simulate the probabilities of achievement, which requires management to make a number of assumptions including 30-day average price, volatility of the underlying stock and the Company’s peers, and the risk-free interest rate.
7 unchanged sentences
Comprehensive gains (losses) have been reflected in the consolidated statements of comprehensive income (loss) for all periods presented.
−Removed: Recently Issued Accounting Guidance Not Yet Adopted
+Added: Recently Adopted Accounting Guidance
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
3 unchanged sentences
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.
+Added: The Company adopted this guidance on its related disclosures.
+Added: Recently Issued Accounting Guidance Not Yet Adopted
+Added: In November 2024, the FASB issued ASU No.
+Added: 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses.
+Added: This guidance is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted.
+Added: This guidance should be applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any or all prior periods presented in the financial statements.
The Company is currently in the process of evaluating the effects of this guidance on its related disclosures.
3 unchanged sentences
The Company is currently in the process of evaluating the impact of this pronouncement on its related disclosures.
+Added: Discontinued Operations
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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: 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.
+Added: 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: 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 financial results of the discontinued operations with respect to FibroGen International reflected in the consolidated statements of operations for the years ended December 31, 2024 and 2023 were as follows (in thousands):
+Added: Years Ended December 31,
+Added: Product revenue, net
+Added: Operating costs and expenses:
+Added: Cost of goods sold
+Added: Research and development
+Added: Selling, general and administrative
+Added: Total operating costs and expenses
+Added: Income from operations
+Added: Interest and other, net
+Added: Interest expense
+Added: Interest income and other income (expenses), net
+Added: Total interest and other, net
+Added: Income before income taxes
+Added: Provision for income taxes
+Added: Investment income in unconsolidated variable interest entity
+Added: Income from discontinued operations, net of tax
+Added: 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 .
+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 and 2023 were as follows (in thousands):
+Added: December 31, 2024
+Added: December 31, 2023
+Added: Cash and cash equivalents
+Added: Accounts receivable, net
+Added: Prepaid expenses and other current assets
+Added: Total current assets held for sale
+Added: Property and equipment, net
+Added: Equity method investment in unconsolidated variable interest entity
+Added: Operating lease right-of-use assets
+Added: Total long-term assets held for sale
+Added: Accounts payable
+Added: Accrued and other current liabilities
+Added: Operating lease liabilities, current
+Added: Total current liabilities held for sale
+Added: Operating lease liabilities, non-current
+Added: Total long-term liabilities held for sale
+Added: The significant non-cash items and capital expenditures for the discontinued operations with respect to FibroGen International included in the consolidated statements of cash flows for the years ended December 31, 2024 and 2023 were as follows (in thousands):
+Added: Years Ended December 31,
+Added: Investment income in unconsolidated variable interest entity
+Added: Dividend received from unconsolidated variable interest entity
+Added: Stock-based compensation
+Added: Purchases of property and equipment
+Added: 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.
+Added: FibroGen Beijing owns 51.1 % of Falikang’s equity.
+Added: For the years ended December 31, 2024 and 2023, the net product revenue from sales to Falikang were $ 159.0 million and $ 89.1 million , respectively.
+Added: The other income from Falikang were immaterial for the years ended December 31, 2024 and 2023.
+Added: For the years ended December 31, 2024 and 2023, the investment income (loss) in Falikang was $ 4.0 million and $ 2.6 million, respectively.
+Added: 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.
+Added: 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.
+Added: As of December 31, 2024 and 2023 accounts receivable, net, from Falikang were $ 13.9 million and $ 5.2 million, respectively.
Collaboration Agreements, License Agreement and Revenues
17 unchanged sentences
The Astellas Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range .
−Removed: On March 21, 2022, EVRENZO ® (roxadustat) was registered with the Russian Ministry of Health.
−Removed: The Company evaluated the regulatory milestone payment associated with the approval in Russia under the Astellas Europe Agreement and concluded that this milestone was achieved in the first quarter of 2022.
−Removed: Accordingly, the consideration of $ 25.0 million associated with this milestone was included in the transaction price and allocated to performance obligations under the Astellas Europe Agreement, all of which was recognized as revenue during the year ended December 31, 2022 from performance obligations satisfied.
−Removed: During the third quarter of 2021, the European Commission approved EVRENZO ® (roxadustat) for the treatment of adult patients with symptomatic anemia associated with CKD.
−Removed: Astellas has launched EVRENZO in Germany, the United Kingdom, the Netherlands, and Austria.
−Removed: This approval triggered a total of $ 120.0 million milestone payable to the Company by Astellas under the Astellas Europe Agreement.
−Removed: Accordingly, the consideration of $ 120.0 million associated with these milestones was included in the transaction price and allocated to performance obligations under the Astellas Europe Agreement, all of which was recognized as revenue during the year ended December 31, 2021 from performance obligations satisfied.
The aggregate amount of the considerations received under the Astellas Europe Agreement through December 31, 2024 totals $ 685.0 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below.
31 unchanged sentences
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 separately as services are provided.
+Added: 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.
There w as no provision for co-development services in the Astellas Japan Agreement.
16 unchanged sentences
License Revenue and Development Revenue Recognized Under the Astellas Agreements
−Removed: License amounts identified below are included in the “License revenue” line item in the consolidated statements of operations.
−Removed: All other elements identified below are included in the “Development and other revenue” line item in the consolidated statements of operations.
−Removed: Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were as follows for the years ended December 31, 2023, 2022 and 2021 (in thousands):
−Removed: Years Ended December 31,
−Removed: Performance Obligation
−Removed: Astellas Japan Agreement
−Removed: Development revenue
−Removed: The transaction price related to consideration received through December 31, 2023 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Japan Agreement, along with any associated deferred revenue as follows (in thousands):
−Removed: Astellas Japan Agreement
−Removed: Total Consideration
−Removed: December 31, 2023
−Removed: Development revenue
−Removed: Total license and development revenue
+Added: 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):
+Added: 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.
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.
4 unchanged sentences
Astellas Europe Agreement
−Removed: License revenue
Development revenue
−Removed: The transaction price related to consideration received through December 31, 2023 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Europe Agreement, along with any associated deferred revenue as follows (in thousands):
−Removed: Astellas Europe Agreement
−Removed: Total Consideration
−Removed: December 31, 2023
−Removed: Development revenue
−Removed: Total license and development revenue
+Added: 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.
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.
4 unchanged sentences
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: The AstraZeneca U.S./RoW Agreement was terminated on February 23, 2024 (except South Korea).
−Removed: China is covered by a separate agreement with AstraZeneca described below.
−Removed: Under the terms of the AstraZeneca U.S./RoW Agreement, AstraZeneca paid upfront, non-contingent, non-refundable and time-based payments totaling $ 374.0 million (such amounts were fully received as of June 2016).
−Removed: Under the AstraZeneca U.S./RoW Agreement, AstraZeneca also agreed to pay an aggregate of approximately $ 875.0 million in potential milestone payments, comprised of (i) up to $ 65.0 million in milestone payments upon achievement of specified clinical and development milestone events, (ii) up to $ 325.0 million in milestone payments upon achievement of specified regulatory milestone events, (iii) up to $ 160.0 million in milestone payments related to activity by potential competitors and (iv) up to approximately $ 325.0 million in milestone payments upon the achievement of specified commercial sales events.
−Removed: Under the AstraZeneca U.S./RoW Agreement, the Company and AstraZeneca equally share in the development costs of roxadustat not already paid for by Astellas, up to a total of $ 233.0 million (i.e.
−Removed: the Company’s share of development costs is $ 116.5 million, which was reached in 2015).
−Removed: Development costs incurred by FibroGen during the development period in excess of the $ 233.0 million (aggregated spend) are fully reimbursed by AstraZeneca.
−Removed: The aggregate amount of the considerations received under the AstraZeneca U.S./RoW Agreement through December 31, 2023 totals $ 439.0 million , excluding drug product revenue that is discussed under the Drug Product Revenue, Net section below.
−Removed: In 2020, the Company entered into a Master Supply Agreement with AstraZeneca under the AstraZeneca U.S./RoW Agreement (“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: The related drug product revenue is described under the Drug Product Revenue, Net section below.
+Added: 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: 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.
+Added: 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: Neither party incurred any early termination penalties.
+Added: The aggregate amount of the considerations received under the AstraZeneca U.S./RoW Agreement through December 31, 2024 totals $ 439.0 million , excluding drug product revenue under the Master Supply Agreement with AstraZeneca under the AstraZeneca U.S./RoW Agreement (“AstraZeneca Master Supply Agreement”), entered in 2020, which is described under the Drug Product Revenue, Net section below.
+Added: 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.
+Added: 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.
+Added: The Company’s collaboration agreement with AstraZeneca for roxadustat in China, as described below, remains in place.
AstraZeneca China Agreement
2 unchanged sentences
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 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.
+Added: 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.
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 .
1 unchanged sentence
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 U.S./RoW Agreement and 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 recorded as a contract asset and was fully netted against the contract liabilities (deferred revenue) related to the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement.
+Added: 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.
+Added: 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.
+Added: 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.
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: Under the AstraZeneca China Amendment, with effect from April 1, 2020, AstraZeneca’s co-promotion expenses for their sales and marketing efforts are subject to a cap of a percentage of net sales.
−Removed: In addition, the AstraZeneca China Amendment has allowed for a higher cost of manufacturing incurred by FibroGen Beijing to be included in the profit or loss share calculation, subject to an annual cap, among other changes.
−Removed: The co-promotion expenses for the years ended December 31, 2023, 2022 and 2021 , capped at a percentage of net roxadustat sales in China, were $ 4.6 million, $ 4.4 million and $ 4.7 million, respectively, included in the selling, general and administrative expenses.
−Removed: Under the AstraZeneca China Amendment, profit/loss share between FibroGen Beijing and AstraZeneca is based on a calculation of the current period net roxadustat sales in China and deductible expenses pursuant to the AstraZeneca China Agreement.
−Removed: Based on the calculation revised under the AstraZeneca China Amendment, profit was achieved during 2020.
−Removed: As a result, the Company recorded a corresponding one-time profit share liability to AstraZeneca, the balance of which was $ 7.1 million and $ 7.3 million as of December 31, 2023 and 2022, respectively, in accrued and other current liabilities in the consolidated balance sheet.
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.
3 unchanged sentences
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.
+Added: Such amount was reached during the year ended December 31, 2024.
Development costs continue to be shared 50/50 between the Parties.
−Removed: The related net product revenue recognized from the sales to Falikang and the sales directly to distributors are discussed under the Product Revenue, Net section below.
+Added: The related net product revenue recognized from the sales to Falikang is discussed under the China Performance Obligation section below.
+Added: 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 .
Accounting for the AstraZeneca Agreements
9 unchanged sentences
There are no right-of-return provisions for the delivered items in the AstraZeneca agreements.
−Removed: As of December 31, 2023 , 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, $ 614.6 million of variable consideration related to co-development billings, offset by $ 7.1 million of variable consideration related to the above-mentioned one-time profit share under the AstraZeneca China Amendment.
+Added: 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.
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.
27 unchanged sentences
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 myelodysplastic syndromes separately as services are provided.
+Added: Subsequently, the Company accounts for the development services for other significant indications related to chemotherapy-induced anemia and MDS separately as services are provided.
(3) Manufacturing of clinical supplies of products.
24 unchanged sentences
Revenue is recognized at a point in time when control of roxadustat commercial product is transferred to Falikang.
−Removed: For the Company’s direct sales of commercial drug product, revenue is recognized when control of the promised good is transferred to the customer in an amount that reflects the consideration that the Company expects to be entitled to in exchange for the product.
−Removed: See the Product Revenue, Net section below.
+Added: See the China Performance Obligation section below.
+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 .
License Revenue and Development Revenue Recognized Under the AstraZeneca Agreements
5 unchanged sentences
Development revenue
−Removed: The transaction price related to consideration received through December 31, 2023 and accounts receivable has been allocated to each of the following performance obligations under the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement, along with any associated deferred revenue as follows (in thousands):
−Removed: AstraZeneca U.S./RoW Agreement and
−Removed: AstraZeneca China Agreement
−Removed: Cumulative Revenue
−Removed: December 31, 2023
−Removed: Deferred Revenue at
−Removed: December 31, 2023
−Removed: Total Consideration
−Removed: December 31, 2023
−Removed: Co-development, information sharing &
−Removed: committee services
−Removed: China performance obligation *
−Removed: Total license and development revenue
−Removed: * China performance obligation revenue is recognized as product revenue, as described in details under Product Revenue, Net section below.
−Removed: ** Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets.
−Removed: As of December 31, 2023, deferred revenue included $ 153.4 million related to the AstraZeneca U.S./RoW and the AstraZeneca China Agreement, which represents the net of $ 179.9 million of deferred revenue presented above and a $ 26.5 million unbilled milestone and co-development revenue under the AstraZeneca China Amendment .
+Added: 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.
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.
−Removed: The remainder of the transaction price related to the AstraZeneca U.S./RoW Agreement and the AstraZeneca China Agreement includes $ 2.3 million of variable consideration from estimated future co-development billing and is expected to be recognized over the remaining development service period, except for amounts allocated to the China performance obligation.
−Removed: The amount allocated to the China performance obligation is expected to be recognized as the Company transfers control of the commercial drug product to Falikang, and is expected to continue through 2033, which reflects the Company’s best estimates, taking into account its estimated loss of exclusivity upon expiry of its composition of matter patent in 2024, its existing patent portfolio, and competition from generics.
−Removed: Product Revenue, Net
−Removed: Product revenue, net from the sales of roxadustat commercial product in China was as follows for the years ended December 31, 2023, 2022 and 2021 (in thousands):
−Removed: Years Ended December 31,
−Removed: Direct Sales:
−Removed: Gross revenue
−Removed: Discounts and rebates
−Removed: Sales returns
−Removed: Direct sales revenue, net
−Removed: Sales to Falikang:
−Removed: Gross transaction price
−Removed: Net transaction price
−Removed: Decrease (increase) in deferred revenue
−Removed: Sales to Falikang revenue, net
−Removed: Total product revenue, net
−Removed: Product revenue from direct roxadustat product sales to distributors in China is recognized in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those products, net of sales rebates and discounts.
−Removed: The discounts and rebates consisted of the price adjustments recorded based on government-listed price guidance and estimated channel inventory levels, the contractual sales rebate calculated based on the stated percentage of gross sales by each distributor in the distribution agreement entered between FibroGen and each distributor, and other rebates and discounts, as well as sales return allowance.
−Removed: The total discounts and rebates were immaterial for the periods presented.
−Removed: Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts are presented as reductions to gross accounts receivable from the distributor, or as a current liability to the distributor to the extent that the total amount exceeds the gross accounts receivable or when the Company expects to settle the discount in cash.
−Removed: The Company’s legal right to offset is determined at the individual distributor level.
−Removed: The contract liabilities were included in accrued and other current liabilities in the consolidated balance sheet and were immaterial as of December 31, 2023 and 2022.
−Removed: The rebates and discounts were reflected as reductions to gross accounts receivable for direct sales and were immaterial as of December 31, 2023 and 2022.
−Removed: Sales to Falikang – China Performance Obligation
+Added: China Performance Obligation
+Added: Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.
Substantially all direct roxadustat product sales to distributors in China are made by Falikang.
4 unchanged sentences
Revenue is recognized when control of the product is transferred to Falikang, in an amount that reflects the allocation of the transaction price to the performance obligation satisfied during the reporting period.
−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.
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: Following updates to its estimates, the Company recognized $ 0.5 million from the previously deferred revenue of the China performance obligation during the year ended December 31, 2023.
−Removed: The product revenue recognized for the year ended December 31, 2023 included a decrease in revenue of 2.9 million resulting from changes to estimated variable consideration in the current period relating to performance obligation satisfied in previous periods.
−Removed: Comparatively, following updates to its estimates, the Company recognized $ 2.3 million from the previously deferred revenue of the China performance obligation during the year ended December 31, 2022.
+Added: 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.
+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 will be satisfied upon the closing of the divestiture FibroGen International.
+Added: The product revenue recognized is included in discontinued operations.
The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands):
December 31, 2023
−Removed: Recognized as Revenue
+Added: (Discontinued
December 31, 2024
−Removed: Product revenue - AstraZeneca China
−Removed: performance obligation - deferred revenue
+Added: AstraZeneca China performance obligation
+Added: - deferred revenue
Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca.
As of 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.
−Removed: Due to the Company’s legal right to offset, at each balance sheet date, the rebates and discounts, mainly related to profit sharing, are presented as reductions to gross accounts receivable from Falikang, which was $ 3.0 million and $ 0.5 million as of December 31, 2023 and 2022 , respectively.
Drug Product Revenue, Net
6 unchanged sentences
Astellas Japan Agreement
−Removed: During the year ended December 31, 2021, the Company updated its estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded adjustments to the drug product revenue of $ 2.1 million.
−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, estimated cost to convert the API to bulk product tablets, and estimated yield from the manufacture of bulk product tablets, among others.
−Removed: During the first quarter of 2022, the Company fulfilled a shipment obligation under the terms of Astellas Japan Amendment, and recognized related drug product revenue of $ 9.8 million in the same period.
−Removed: During the fourth quarter of 2022, the Company fulfilled a shipment obligation under the terms of Astellas Japan Amendment, and recognized related drug product revenue of $ 8.4 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 Japan Amendment with Astellas, and recorded a reduction to the drug product revenue of $ 8.7 million during the year ended December 31, 2022.
−Removed: Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect foreign currency translation impact, the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, estimated cost to convert the API to bulk product tablets, and estimated yield from the manufacture of bulk product tablets, among others.
+Added: 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.
+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.
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.
2 unchanged sentences
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.
−Removed: As of December 31, 2022, the related balance in accrued liabilities was $ 6.5 million .
+Added: As of December 31, 2023, the balances related to the API price true-up under the Astellas Japan Agreement were $ 1.2 million in accrued liabilities and $ 0.7 million in other long-term liabilities .
Astellas Europe Agreement
−Removed: During the first quarter of 2021, the Company transferred bulk drug product from process validation supplies for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement.
−Removed: The Company recorded the consideration of $ 11.8 million from this inventory transfer as deferred revenue as of December 31, 2021, due to a high degree of uncertainty associated with the final consideration.
−Removed: During the fourth quarter of 2021, 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 $ 1.0 million as drug product revenue, and recorded $ 8.3 million as deferred revenue as of December 31, 2021, due to a high degree of uncertainty associated with the final consideration.
−Removed: In addition, during the fourth quarter of 2021, the Company updated its estimate of variable consideration related to the bulk drug product inventory transfers fulfilled under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recorded an unbilled contract asset of $ 49.8 million, which was offset by related deferred revenue under the Astellas Europe Agreement and Astellas EU Supply Agreement.
−Removed: Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, among others.
−Removed: During the second quarter of 2022, 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 $ 1.0 million as drug product revenue, and recorded $ 23.2 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes.
−Removed: During the first quarter of 2022, the Company billed and received $ 49.2 million from Astellas related to the annual transfer price true up for bulk drug product transferred for commercial purposes.
−Removed: This amount was recorded in deferred revenue and netted against an unbilled contract asset as of December 31, 2021.
+Added: During the fourth quarter of 2024, the Company transferred bulk drug product for commercial purposes under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and recognized the related fully-burdened manufacturing costs of $ 0.6 million as drug product revenue, and recorded $ 4.4 million as deferred revenue due to a high degree of uncertainty associated with the variable consideration for revenue recognition purposes.
In addition, the Company updated its estimate of variable consideration related to the bulk drug product transferred in prior years.
Specifically, the change in estimated variable consideration was based on the bulk drug product held by Astellas at the period end, adjusted to reflect the changes in the estimated transfer price, forecast information, shelf-life estimates and other items.
−Removed: As a result, during the year ended December 31, 2022, the Company reclassified a total of $ 57.4 million from the related deferred revenue to accrued liabilities , which was paid to Astellas during 2023.
+Added: As a result, for the year ended December 31, 2024, the Company reclassified $ 7.2 million from the related deferred revenue to accrued liabilities.
During the fourth quarter of 2023, 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 $ 0.8 million as drug product revenue, and recorded $ 17.7 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, 2023, the Company reclassified $ 38.7 million from the related deferred revenue to accrued liabilities.
+Added: The Company paid $ 35.3 million to Astellas during the year ended December 31, 2024.
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.
+Added: As of December 31, 2023, the related balance in accrued liabilities was $ 38.6 million.
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.
8 unchanged sentences
AstraZeneca U.S./RoW Agreement
−Removed: During the years ended December 31, 2021 and 2020, the Company shipped bulk drug product to AstraZeneca as commercial supply under the terms of the Master Supply Agreement.
−Removed: Based on the complete response letter issued by the U.S.
−Removed: Food and Drug Administration in August 2021, the Company evaluated the impact of these developments in revising its estimates of variable consideration associated with drug product revenue.
−Removed: As a result, the Company updated the estimated transaction price for these shipments, and recorded $ 11.2 million as deferred revenue as of December 31, 2021.
−Removed: The related drug product revenue was $( 2.2 ) million for the year ended December 31, 2021.
−Removed: During the first quarter of 2022, the Company evaluated the current developments in the U.S.
−Removed: market, and updated its estimates of variable consideration associated with bulk drug product shipments to AstraZeneca in prior years as commercial supply.
−Removed: As a result, during the year ended December 31, 2022, the Company reclassified $ 11.2 million from the related deferred revenue to accrued liabilities, which remained unchanged as of December 31, 2023 , representing its best estimate that this amount will be paid within the next 12 months.
+Added: 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.
+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 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.
+Added: In addition, the related accrued liabilities of $ 11.2 million as of December 31, 2023 was settled during the second quarter of 2024.
+Added: Corresponding to the drug product revenue, during the first quarter of 2024, the Company recorded the related cost of goods sold of $ 21.1 million.
Eluminex Agreements
12 unchanged sentences
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 year ended December 31, 2021, the Company recognized an $ 8.0 million upfront payment to FibroGen as license revenue for the performance obligation satisfied and included in license revenue in the consolidated statement of operations.
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: Supply of the cornea product will be managed by a separate agreement and is considered a separate performance obligation.
−Removed: The related contract manufacturing revenue was recorded as other revenue and included in development and other revenue in the consolidated statement of operations.
+Added: The related contract manufacturing revenue was recorded as other revenue and included in development and other revenue in the condensed consolidated statement of operations.
+Added: Such contract manufacturing activity was generally ceased during the first quarter of 2024.
Amounts recognized as revenue under the agreements with Eluminex were as follows for the years ended December 31, 2024 and 2023 (in thousands):
2 unchanged sentences
License revenue
−Removed: Other revenue - patent transfer
Other revenue - contract manufacturing
−Removed: Exclusive License and Option to Acquire Fortis Therapeutics
−Removed: On May 5, 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: 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.
−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: 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.
−Removed: Therefore, the Company consolidated Fortis starting from the Option Acquisition Date, and continues to consolidate as of December 31, 2023.
−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.
−Removed: The fair value of the consideration transferred was zero .
−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 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: Additionally, the Company is obligated to make four quarterly payments totaling $ 5.0 million to Fortis in support of its continued development obligations.
−Removed: The Company determined that these payments should not be included in the purchase consideration, as those payments are payable to Fortis rather than to its shareholders.
−Removed: 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.
−Removed: Subsequent to the Option Acquisition Date, Fortis’ net income is allocated to its common shares and preferred shares based on their respective stated rights.
−Removed: 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 following table represents the allocation of purchase consideration based on estimated fair values of the acquired assets (in thousands):
−Removed: Estimated Fair Value as of the Option Acquisition Date
−Removed: Purchase consideration
−Removed: Cash and cash equivalents
−Removed: Prepaid expenses and other current assets
−Removed: Accounts payable
−Removed: Accrued and other current liabilities
−Removed: Total liabilities
−Removed: Redeemable non-controlling interests
−Removed: Nonredeemable non-controlling interests
−Removed: Net identifiable assets, liabilities and non-controlling interests
−Removed: Loss on asset acquisition
−Removed: The Company used a third party valuation specialist to determine the fair value of the IPR&D assets using a risk-adjusted net present value discounted cash flow model (the “rNPV”) with the following key assumptions:
−Removed: (i) estimated cash flow forecasts of peak sales, sales penetration, remaining IPR&D related product development costs, and other related general and administrative costs;
−Removed: (ii) probabilities of technical success of future underlying Phase II and Phase III clinical trials and ensuing probability of regulatory approval related to the IPR&D assets;
−Removed: and (iii) estimate of a risk-adjusted discount rate of 16.5 %.
−Removed: The acquired IPR&D assets were determined to have no alternative future use.
−Removed: Accordingly, 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.
−Removed: 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 consistent with the assumptions under the rNPV, and discounted by the Company’s estimated market level cost of debt.
−Removed: As of December 31, 2023, total assets and liabilities of Fortis were immaterial.
−Removed: For the period from the Option Acquisition Date to December 31, 2023, Fortis’ net income (losses) was immaterial.
−Removed: Equity method investment - Variable Interest Entity
−Removed: Falikang is a distribution entity jointly owned by AstraZeneca and FibroGen Beijing.
−Removed: FibroGen Beijing owns 51.1 % of the outstanding shares of Falikang.
−Removed: Pursuant to the guidance under ASC 810, the Company concluded that Falikang qualifies as a VIE.
−Removed: As Falikang is a distribution entity and AstraZeneca is the final decision maker for all the roxadustat commercialization activities, the Company lacks the power criterion, while AstraZeneca meets both the power and economic criteria under the ASC 810 to direct the activities of Falikang that most significantly impact its performance.
−Removed: Therefore, the Company is not the primary beneficiary of this VIE for accounting purposes.
−Removed: As a result, the Company accounts for its investment in Falikang under the equity method, and Falikang is not consolidated into the Company’s consolidated financial statements.
−Removed: The Company records its total investments in Falikang as an equity method investment in an unconsolidated VIE in the consolidated balance sheet.
−Removed: In addition, the Company recognizes its proportionate share of the reported profits or losses of Falikang as investment gain or loss in unconsolidated VIE in the consolidated statement of operations and as an adjustment to its investment in Falikang in the consolidated balance sheet.
−Removed: The Company may provide shareholder loans to Falikang to meet necessary financial obligations as part of its operations.
−Removed: To date, there has been no such loans.
−Removed: During the year ended December 31, 2023, the Company received $ 2.3 million of dividend distribution from Falikang.
−Removed: The Company’s equity method investment in Falikang was as follows for the year ended December 31, 2023 (in thousands):
−Removed: Ownership Percentage
−Removed: December 31, 2022
−Removed: Share of Net Income
−Removed: Dividend Received
−Removed: December 31, 2023
−Removed: Falikang is considered as a related party to the Company.
−Removed: See Note 16, Related Party Transactions , for related disclosures.
−Removed: On an ongoing basis, the Company re-evaluates the VIE assessment based on changes in facts and circumstances, including but not limited to, the shareholder loans received by Falikang and the execution of any future significant agreements between Falikang and its shareholders and/or other third parties.
−Removed: In addition, t he Company assesses the impairment of its equity method investment whenever events or changes in circumstances indicate that a decrease in value of the investment has occurred that is other than temporary.
−Removed: There has been no such event or change in circumstances to date.
−Removed: Fair Value Measurements
−Removed: In accordance with the authoritative guidance on fair value measurements and disclosures under U.S.
−Removed: GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis.
−Removed: The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements.
−Removed: The guidance also requires fair value measurements be classified and disclosed in one of the following three categories:
−Removed: Quoted prices in active markets for identical assets or liabilities.
−Removed: Observable inputs other than quoted prices in active markets for identical assets or liabilities.
−Removed: Unobservable inputs.
−Removed: The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs.
−Removed: The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2).
−Removed: The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability.
−Removed: In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S.
−Removed: government guarantees.
−Removed: Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
−Removed: The availability of observable data is monitored to assess appropriate classification of financial instruments within the fair value hierarchy.
−Removed: Depending upon the availability of such inputs, specific securities may transfer between levels.
−Removed: In such instances, the transfer is reported at the end of the reporting period.
−Removed: The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):
−Removed: December 31, 2023
−Removed: Money market funds
−Removed: Corporate bonds
−Removed: Commercial paper
−Removed: government bonds
−Removed: December 31, 2022
−Removed: Money market funds
−Removed: Corporate bonds
−Removed: Commercial paper
−Removed: government bonds
−Removed: Asset-backed securities
−Removed: Foreign government bonds
−Removed: Convertible promissory note
−Removed: The Company’s Level 2 investments are valued using third-party pricing sources.
−Removed: The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value.
−Removed: These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs.
−Removed: During the years ended December 31, 2023 and 2022, the transfers of assets between levels was a total of $ 20.4 million and $ 10.5 million transfer from Level 1 to Level 2, respectively, as such US treasury notes and bills were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day.
−Removed: There were no transfers of assets between levels for the year ended December 31, 2021.
−Removed: The Company’s long-term property lease with Alexandria for its corporate headquarters in San Francisco, California, had an initial term of 15 years, scheduled to expire in 2023 .
−Removed: The original lease was accounted for as a finance lease.
−Removed: On June 1, 2021, the Company entered into an amendment with Alexandria to extend the lease to 2028 (“Lease Amendment”).
−Removed: Under the terms of the Lease Amendment, the Company has two optional rights to each extend the lease for an additional five years .
−Removed: The lease contract provides for a fixed annual rent, with scheduled increases of two percent that occur on each anniversary of the rent commencement date through 2023 , and with scheduled increases of three percent that occur on each anniversary of the rent commencement date through 2028 .
−Removed: This lease requires the Company to pay all costs of ownership, operation, and maintenance of the premises, including without limitation all operating costs, insurance costs, and taxes.
−Removed: The Company determined that the Lease Amendment was a lease modification, effective June 1, 2021, and thus reassessed the lease classification, remeasured the related lease liability using an updated discount rate, and adjusted the related right-of-use asset under the lease modification guidance under the ASC 842.
−Removed: Accordingly, on June 1, 2021, the Company determined that the modified lease be accounted for as an operating lease, and therefore derecognized the previous finance lease right-of-use asset of $ 24.6 million and the related finance lease liability of $ 32.6 million, and recognized an operating lease right-of-use asset of $ 93.2 million and the related operating lease liability of $ 101.2 million.
−Removed: Starting June 1, 2021, the cash payment related to this lease was classified as an operating activity.
−Removed: During the first quarter of 2021, after FibroGen Beijing’s previous long-term lease agreement expired, the Company entered into a new lease agreement with the landlord for the same pilot plant located in Beijing Yizhuang Biomedical Park of BDA.
−Removed: The new lease term is five year , scheduled to expire in 2026 , and is treated as an operating lease.
−Removed: Accordingly, the Company recorded $ 3.4 million in the operating right-of-use assets and total operating lease liabilities, respectively.
−Removed: The lease contract provides for fixed quarterly rent payments, and requires the Company to pay operating and maintenance costs.
−Removed: The Company currently has several additional real estate leases for office spaces in Shanghai and Beijing, China, which are treated as operating leases.
−Removed: These leases have lease terms ranging from one to five years , expiring in 2026 .
−Removed: These lease contracts provide for fixed quarterly rent payments, and require the Company to pay operating and maintenance costs, and a fixed amount for property management fees.
−Removed: In addition, the Company has several immaterial lease arrangements in China and U.S.
−Removed: for office equipment and automobile leases, with contracted lease terms ranging from one to six years , treated as finance leases or operating leases.
+Added: Other revenue - patent transfer
+Added: 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.
+Added: 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.
+Added: 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;
+Added: and a $ 1.7 million security deposit, in the form of a letter of credit.
+Added: 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.
+Added: The Company ceased the use of the underlying operating lease right-of-use asset by September 30, 2024.
+Added: 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.
+Added: As of December 31, 2024, the Company did not have any operating lease and restricted time deposit.
+Added: In addition, the Company has several immaterial lease arrangements in the U.S.
+Added: for office equipment, with contracted lease terms up to six years , treated as finance leases.
+Added: The Company’s operating and finance leases were classified within the consolidated balance sheets as held for sale for all periods presented.
+Added: See Note 3, Discontinued Operations , for details.
The Company’s lease assets and related lease liabilities were as follows (in thousands):
26 unchanged sentences
Selling, general and administrative expenses
−Removed: Interest on lease liabilities
−Removed: Interest expense
Operating lease cost
5 unchanged sentences
Total lease cost
−Removed: Supplemental cash flow information related to leases 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
−Removed: Increase (decrease) resulting from lease modification:
−Removed: Finance lease right-of-use assets
−Removed: Operating lease right-of-use assets
−Removed: Finance lease liabilities, current
−Removed: Operating lease liabilities, current
−Removed: Finance lease liabilities, non-current
−Removed: Operating lease liabilities, non-current
Lease term and discount rate were as follows:
5 unchanged sentences
Operating leases
−Removed: Maturities of lease liabilities as of December 31, 2023 are as follows (in thousands):
−Removed: Year Ending December 31,
+Added: Supplemental cash flow information related to leases in the U.S.
+Added: and China were as follows (in thousands):
+Added: Years Ended December 31,
+Added: Cash paid for amounts included in the measurement of lease liabilities:
+Added: Operating cash flows from operating leases
+Added: Operating cash flows from finance leases
+Added: Financing cash flows from finance leases
+Added: Right-of-use assets obtained in exchange for new lease liabilities:
Finance leases
Operating leases
−Removed: Total future lease payments
−Removed: Present value of lease liabilities
+Added: Consolidated Variable Interest Entity - Fortis
+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 antibody-drug conjugate, 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 metastatic castration-resistant prostate cancer with potential applicability in other solid tumors and hematologic malignancies.
+Added: 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.
+Added: 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 .
+Added: If FibroGen 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”), 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.
+Added: Food and Drug Administration for the purpose of progressing to a Phase 3 clinical trial or May 2027 absent extension).
+Added: 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.
+Added: 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: 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.
+Added: Therefore, the Company consolidated Fortis starting from the Option Acquisition Date, and continues to consolidate as of December 31, 2024.
+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 IPR&D asset.
+Added: The fair value of the consideration transferred was zero .
+Added: The Company determined that the above mentioned quarterly payments to support Fortis’ continued development obligations should not be included in the purchase consideration, as those payments are payable to Fortis rather than to its shareholders.
+Added: Fortis has authorized and issued common shares and Series A preferred shares.
+Added: 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.
+Added: The NCI attributable to the common shares is classified as nonredeemable NCI, as it is 100 % owned by third party shareholders.
+Added: 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: Subsequent to the Option Acquisition Date, Fortis’ net income is allocated to its common shares and preferred shares based on their respective stated rights.
+Added: 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.
+Added: 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 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.
+Added: As of December 31, 2024 and 2023 , total assets and liabilities of Fortis were immaterial.
+Added: 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: Fair Value Measurements
+Added: In accordance with the authoritative guidance on fair value measurements and disclosures under U.S.
+Added: GAAP, the Company presents all financial assets and liabilities and any other assets and liabilities that are recognized or disclosed at fair value on a nonrecurring basis.
+Added: The guidance defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles and expands disclosures about fair-value measurements.
+Added: The guidance also requires fair value measurements be classified and disclosed in one of the following three categories:
+Added: Quoted prices in active markets for identical assets or liabilities.
+Added: Observable inputs other than quoted prices in active markets for identical assets or liabilities.
+Added: Unobservable inputs.
+Added: The Company values certain assets and liabilities, focusing on the inputs used to measure fair value, particularly in instances where the measurement uses significant unobservable (Level 3) inputs.
+Added: The Company’s financial instruments are valued using quoted prices in active markets (Level 1) or based upon other observable inputs (Level 2).
+Added: The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability.
+Added: In addition, the categories presented do not suggest how prices may be affected by the size of the purchases or sales, particularly with the largest highly liquid financial issuers who are in markets continuously with non-equity instruments, or how any such financial assets may be impacted by other factors such as U.S.
+Added: government guarantees.
+Added: Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
+Added: The availability of observable data is monitored to assess appropriate classification of financial instruments within the fair value hierarchy.
+Added: Depending upon the availability of such inputs, specific securities may transfer between levels.
+Added: In such instances, the transfer is reported at the end of the reporting period.
+Added: The fair values of the Company’s financial assets that are measured on a recurring basis are as follows (in thousands):
+Added: December 31, 2024
+Added: Money market funds
+Added: Commercial paper
+Added: government bonds
+Added: December 31, 2023
+Added: Money market funds
+Added: Corporate bonds
+Added: Commercial paper
+Added: government bonds
+Added: The Company’s Level 2 investments are valued using third-party pricing sources.
+Added: The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value.
+Added: These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs.
+Added: During the years ended December 31, 2024 and 2023, the transfers of assets between levels was a total of $ 26.3 million and $ 20.4 million transfer from Level 1 to Level 2, respectively, as such US treasury notes and bills were changed to off-the-run when they were issued before the most recent issue and were still outstanding at measurement day.
Balance Sheet Components
5 unchanged sentences
Total cash and cash equivalents
−Removed: At December 31, 2023 and 2022, a total of $ 32.2 million and $ 92.5 million , respectively, of the Company’s cash and cash equivalents were held outside of the U.S.
−Removed: in its foreign subsidiaries to be used primarily for its China operations.
−Removed: The Company’s investments consist primarily of available-for-sale debt investments.
−Removed: 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):
−Removed: December 31, 2023
−Removed: Amortized Cost
−Removed: Gross Unrealized
−Removed: Holding Gains
−Removed: Gross Unrealized
−Removed: Holding Losses
−Removed: Corporate bonds
−Removed: Commercial paper
−Removed: government bonds
−Removed: Total investments
+Added: The Company did no t have any short-term or long-term investments as of December 31, 2024 .
+Added: As of December 31, 2023, The Company’s investments consist primarily of available-for-sale debt investments and the amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands):
December 31, 2023
7 unchanged sentences
government bonds
−Removed: Asset-backed securities
−Removed: Foreign government bonds
−Removed: Convertible promissory note
Total investments
−Removed: The following table summarizes, for all available for sale securities in an unrealized loss position, 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: 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):
December 31, 2023
9 unchanged sentences
government bonds
−Removed: Asset-backed securities
−Removed: Foreign government bonds
−Removed: The contractual maturities of all available-for-sale investments were with in one year as of December 31, 2023.
−Removed: The Company periodically reviews its available-for-sale investments for other-than-temporary impairment.
−Removed: The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell.
+Added: The Company periodically assesses whether the unrealized losses on its available-for-sale investments were temporary.
+Added: The Company considers factors such as the severity and the reason for the decline in value, the potential recovery period and its intent to sell.
For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses.
−Removed: During the three years ended December 31, 2023 , the Company did no t recognize any other-than-temporary impairment loss.
+Added: 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, 2024.
Inventories consisted of the following (in thousands):
1 unchanged sentence
Work-in-progress
−Removed: Finished goods
Total inventories
+Added: 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.
The provision to write-down excess and obsolete inventory were immaterial as of December 31, 2024 and December 31, 2023.
1 unchanged sentence
Prepaid expenses and other current assets consisted of the following (in thousands):
−Removed: Contract assets
−Removed: Deferred revenues from associated contracts
−Removed: Net contract assets
Insurance proceeds receivable for litigation settlement
2 unchanged sentences
Total prepaid expenses and other current assets
−Removed: The unbilled contract assets as of December 31, 2023 and 2022 included $ 22.5 million and $ 17.5 million, respectively, related to unbilled co-development revenue under the AstraZeneca China Amendment.
−Removed: In addition, the unbilled contract assets as of December 31, 2023 included the $ 4.0 million unbilled regulatory milestone payment under the AstraZeneca China Agreement.
−Removed: See the AstraZeneca China Agreement section in Note 3, Collaboration Agreements, License Agreement and Revenues , for details.
−Removed: As of December 31, 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, 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.
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.
7 unchanged sentences
Furniture and fixtures
−Removed: Construction in progress
Total property and equipment
1 unchanged sentence
Property and equipment, net
−Removed: Depreciation expense for the years ended December 31, 2023, 2022 and 2021 was $ 9.5 million , $ 10.0 million and $ 10.2 million , respectively.
+Added: 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.
+Added: 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
4 unchanged sentences
Payroll and related accruals
−Removed: Accrued co-promotion expenses - current
−Removed: Roxadustat profit share to AstraZeneca
−Removed: Property taxes and other taxes
+Added: Accrued restructuring charge
Professional services
Current portion of liability related to sale of future revenues
−Removed: Accrued restructuring charge
Total accrued and other current liabilities
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.
+Added: During the second quarter of 2024, the Company paid $ 35.3 million to Astellas and $ 11.5 million to AstraZeneca 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, 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 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.
See the Prepaid Expenses and Other Current Assets section above, and the Legal Proceedings and Other Matters section in Note 12, Commitments and Contingencies , for details.
−Removed: On July 14, 2023, the Company approved a restructuring plan (the “Plan”) to lower the Company’s operating expenses.
−Removed: The Plan included a reduction to the Company’s U.S.
−Removed: workforce of approximately 32 %.
−Removed: As a result, the Company 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.
−Removed: During the year ended December 31, 2023, total cash payments under the Plan was $ 8.9 million.
−Removed: The remaining accrued restructuring charge was $ 3.7 million as of December 31, 2023 and will be substantially paid out by early 2024.
−Removed: The Plan is in connection with the Company’s efforts to streamline operations to align with the Company’s business goals.
+Added: Responding to the reported results for pamrevlumab in July 2024, the Company implemented an immediate and significant cost reduction plan in the U.S., including terminating pamrevlumab research and development investment and expeditiously wind down remaining obligations, and reducing U.S.
+Added: workforce by approximately 75 %.
+Added: 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.
+Added: Total cash payments under the reduction in force was $ 16.5 million during the year ended December 31, 2024.
+Added: 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.
+Added: 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.
Senior Secured Term Loan Facilities
−Removed: On April 29, 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”).
+Added: In April 2023, the Company entered into a financing agreement (“Financing Agreement”) with investment funds managed by Morgan Stanley Tactical Value, as lenders (the “Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of (i) a $ 75.0 million initial term loan (the “Initial Term Loan”), (ii) a $ 37.5 million delayed draw term loan that will be funded upon the achievement of certain clinical development milestones (“Delayed Draw Term Loan 1”) and, (iii) an uncommitted delayed draw term loan of up to $ 37.5 million to be funded at the Lenders sole discretion, (“Delayed Draw Term Loan 2” and, together with the Initial Term Loan and Delayed Draw Term Loan 1, the “Term Loans”).
Pursuant to the Financing Agreement, the Lenders have funded the Initial Term Loan.
The clinical development milestones which could have triggered Delayed Draw Term Loan 1 were not achieved, and the Lenders have not funded Delayed Draw Term Loan 2.
−Removed: As such, these features have expired as of December 31, 2023.
+Added: As such, these features expired during 2023.
+Added: The Company has determined that certain other features embedded within the Loan should be bifurcated and accounted for separately as a derivative.
+Added: 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.
The Term Loans shall accrue interest at a fixed rate of 14.0 % per annum, payable monthly in arrears.
2 unchanged sentences
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: On May 8, 2023, the Company received $ 74.1 million, representing the Initial Term Loan of $ 75.0 million net of $ 0.9 million issuance costs.
+Added: 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.
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.
The effective annual interest rate of the Initial Term Loan was 16.13 % for the year ended December 31, 2024.
−Removed: The Company recorded interest expense of $ 7.4 million for the year ended December 31, 2023.
−Removed: As of December 31, 2023 , the related accrued interest was $ 0.4 million.
+Added: 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.
+Added: As of December 31, 2024 and 2023, the related accrued interest was $ 0.4 million, respectively.
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.
1 unchanged sentence
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, 2023 were as follows (in thousands):
−Removed: December 31, 2023
+Added: The Company’s senior secured term loan facilities as of December 31, 2024 and 2023 were as follows (in thousands):
Principal of senior secured term loan facilities
4 unchanged sentences
Liability Related to Sale of Future Revenues
−Removed: On November 4, 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with NQ Entity, L.P.
−Removed: (“NovaQuest”), pursuant to which the Company granted a percentage interest in the Company’s future revenues under the Astellas Agreements, for a consideration of $ 50.0 million (“Investment Amount”) before advisory fees.
−Removed: Effective as of November 2022, the Company sold to 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 under the Astellas Agreements.
−Removed: In November 2022, t he Company received $ 49.8 million from NovaQuest at an initial funding on November 17, 2022, representing the gross proceeds of $ 50.0 million (the “Initial Investment Amount”) net of initial issuance costs, and accounted for it as long-term debt based on the terms of the RIFA because the risks and rewards to NovaQuest are limited by the terms of the transaction.
+Added: In November 2022, the Company entered into a Revenue Interest Financing Agreement (the “RIFA”) with NQ Entity, L.P.
+Added: (“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.
+Added: In November 2022, the Company received the Investment Amount, net of initial issuance costs, and accounted for it as long-term debt based on the terms of the RIFA because the risks and rewards to NovaQuest are limited by the terms of the transaction.
The related debt discount and transaction costs are amortized as interest expense based on the projected balance of the liability as of the beginning of each period.
14 unchanged sentences
On a quarterly basis, the Company reassesses the expected total revenue and the timing of such revenue, recalculates the amortization of debt discount and transactions costs and effective interest rate, and adjusts the accounting prospectively as needed.
−Removed: The total debt discount and transaction costs of $ 1.7 million, is amortized as interest expense based on the projected balance of the liability as of the beginning of each period.
−Removed: The Company estimated an effective annual interest rate of approximately 16.03 % and 19.67 % for the years ended December 31, 2023 and 2022, respectively.
−Removed: As payments are made to NovaQuest, the balance of the liability related to sale of future revenues is being effectively repaid over the life of the RIFA.
+Added: The Company’s estimated effective annual interest rate was 15.60 % as of December 31, 2024.
The table below shows the activity of the liability related to sale of future revenues for the year ended December 31, 2024:
1 unchanged sentence
Liability related to sale of future revenues - beginning balance
+Added: Interest paid
Interest expense recognized
2 unchanged sentences
Liability related to sale of future revenues, non-current
−Removed: During the years ended December 31, 2023 and 2022 , the Company recognized, under Astellas Agreements, drug product revenue of $ 18.8 million and $ 11.1 million, respectively.
−Removed: In addition, during the year ended December 31, 2022, the Company recognized, under Astellas Agreements, license revenue of $ 22.6 million and development revenue of $ 2.4 million related to a $ 25.0 million regulatory milestone.
+Added: During the years ended December 31, 2024 and 2023, the Company recognized, under Astellas Agreements, development revenue of $ 1.4 million and $ 6.7 million , respectively, and drug product revenue of $ 2.0 million and $ 18.8 million , respectively.
See Note 4, Collaboration Agreements, License Agreement and Revenue , for details.
−Removed: During the years ended December 31, 2023 and 2022 , the Company recognized the related non-cash interest expense of $ 7.7 million and $ 1.0 million, respectively.
+Added: During the years ended December 31, 2024 and 2023 , the Company recognized the related interest expense of $ 7.9 million and $ 7.7 million, respectively.
+Added: During the year ended December 31, 2024, the Company paid $ 5.7 million accrued interest.
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.
12 unchanged sentences
Due In The Year Ending December 31,
−Removed: Manufacture and supply of pamrevlumab
+Added: General purchases and other programs
+Added: Manufacture and supply of FG-3246
Manufacture and supply of roxadustat
−Removed: Other purchases and programs
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 7, Leases , for details of the Company's operating and finance lease payment obligations.
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.
−Removed: Some of the Company’s license agreements provide for periodic maintenance fees over specified time periods, as well as payments by the Company upon the achievement of development, regulatory and commercial milestones.
−Removed: As of December 31, 2023 , future milestone payments for research and preclinical stage development programs consisted of up to approximately $ 697.9 million in total potential future milestone payments under the Company’s license agreements with HiFiBiO (for Gal-9 and CCR8), Medarex, Inc.
−Removed: These milestone payments generally become due and payable only upon the achievement of certain developmental, clinical, regulatory and/or commercial milestones.
−Removed: The event triggering such payment or obligation has not yet occurred.
Legal Proceedings and Other Matters
3 unchanged sentences
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 current and former executive officers (collectively, the “Defendants”) in the U.S.
+Added: Between April 2021 and May 2021, five putative securities class action complaints were filed against FibroGen and certain of its former executive officers (collectively, the “Defendants”) in the U.S.
District Court for the Northern District of California.
3 unchanged sentences
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, 2023, the Company recor ded the $ 28.5 million in accrued and other current liabilities in the consolidated balance sheet.
+Added: 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.
The Company maintains insurance that covers exposure related to the class action lawsuit.
1 unchanged sentence
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: 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.
+Added: The court entered a class distribution order on January 1, 2025.
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 December 5, 2023, six shareholder derivative complaints were filed, naming as defendants certain of our current and former officers and certain current and former members of our board, as well as FibroGen as nominal defendants (the “Derivative Lawsuits”).
−Removed: Of these Derivative Lawsuits, three were filed in the Delaware Court of Chancery, two were filed in the U.S.
+Added: 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”).
+Added: Of these Derivative Lawsuits, four were filed in the Delaware Court of Chancery, two were filed in the U.S.
District Court for the District of Delaware (the “Delaware Federal Derivative Actions”), and one was filed in the U.S.
2 unchanged sentences
The complaints seek unspecified damages, attorneys’ fees, and other costs.
−Removed: The status of the six Derivative Lawsuits is currently as follows:
+Added: The status of the seven Derivative Lawsuits is currently as follows:
• 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.
−Removed: In another derivative action, filed in the Delaware Court of Chancery on December 3, 2023, Defendants have not been served;
−Removed: • The Delaware Federal Derivative actions remain stayed.
−Removed: One is stayed pending the resolution of the putative securities class action, and the other is stayed pending resolution of the motion to dismiss the Delaware Chancery Consolidated Derivative action;
+Added: On February 1, 2024, Defendants moved to dismiss the Delaware Chancery Consolidated Derivative action, which the Court granted on October 2, 2024.
+Added: On October 30, 2024, the Delaware Chancery Consolidated Derivative was dismissed with prejudice.
+Added: 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;
+Added: • The Delaware Federal Derivative actions were voluntarily dismissed on November 14, 2024 and January 16, 2025;
• The California Federal Derivative action was voluntarily dismissed on January 22, 2024.
2 unchanged sentences
In the fourth quarter of 2021, the Company received a subpoena from the SEC requesting documents related to roxadustat’s pooled cardiovascular safety data.
−Removed: The Company is fully cooperating with the SEC.
−Removed: The Company cannot predict with any degree of certainty the outcome of the SEC’s investigation or determine the extent of any potential liabilities.
−Removed: The Company also cannot predict whether there will be any loss as a result of the investigation nor can it provide an estimate of the possible loss or range of loss.
+Added: The SEC followed up with a subpoena for additional documents in the second quarter of 2024.
+Added: The Company is fully cooperating with the SEC, and is currently discussing a potential resolution.
+Added: The Company cannot predict the outcome.
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 2023, the Company’s Board of Directors received five 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 such additional demands.
+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 pending derivative and securities class action lawsuits.
+Added: The Company may in the future receive additional similar demands.
Starting in October 2021, certain challenges have been filed with the China National Intellectual Property Administration against patents which claim a crystalline form of roxadustat.
18 unchanged sentences
At-the-Market Program
−Removed: On February 27, 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.
+Added: On February 24, 2025, the Company entered into an Equity Distribution Agreement with BofA Securities, Inc.
+Added: (“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.
+Added: 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.
(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.
as an additional Sales Agent under that agreement.
−Removed: Under the at-the-market agreement, the Company may 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 (the “ATM Program”).
−Removed: For the year ended December 31, 2023 , the Company sold 2,472,090 shares under the 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 .
+Added: 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.
+Added: 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 .
+Added: The Company did no t sell any shares of common stock under this ATM program during the year ended December 31, 2024.
+Added: 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.
Stock Option and RSU Plans
6 unchanged sentences
Options generally vest over four years .
−Removed: Options expire no more than 10 years after the date of grant.
+Added: Options expire no more than ten years after the date of grant.
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.
−Removed: In September 2014, the Company adopted a 2014 Equity Incentive Plan (the “2014 Plan”) which became effective on November 13, 2014.
+Added: 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 will terminate on November 12, 2024 .
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.
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 ( 25 % vesting on the first anniversary of the vesting base date and quarterly thereafter over the next 3 years).
+Added: Option vesting schedules are determined by the Company at the time of issuance and generally have a four year vesting schedule.
Options generally expire ten years from the date of grant unless the optionee is a 10% stockholder, in which case the term will be five years from the date of grant.
1 unchanged sentence
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.
+Added: In June 2024, the Company’s 2024 Equity Incentive Plan (the “2024 Plan”), the successor to and continuation of the 2014 Plan, became effective.
+Added: The 2024 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and performance stock awards to employees, directors and consultants.
+Added: Stock options granted must be at prices not less than 100 % of the fair market value at date of grant.
+Added: Option vesting schedules are 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 unless the optionee is a 10% stockholder, in which case the term will be five years from the date of grant.
+Added: Unvested options exercised are subject to the Company’s repurchase right.
As of December 31, 2024 , the Company has reserved 19,461,785 shares of its common stock that remains unissued for issuance under the 2024 Plan.
11 unchanged sentences
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.
−Removed: During the year ended December 31, 2023 , 110,370 shares of the TSR awards have vested and been released.
+Added: During the year ended December 31, 2024 , no TSR awards shares have vested and been released.
Stock option transactions, including forfeited options granted under the 2024 Plan as well as prior plans, are summarized below:
9 unchanged sentences
The estimated weighted-average fair value of the stock options granted during the years ended December 31, 2024 and 2023 was $ 1.74 and $ 7.27 , respectively.
−Removed: The total intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was $ 0.9 million, $ 0.8 million and $ 13.1 million, respectively.
+Added: The total intrinsic value of options exercised during the years ended December 31, 2024 and 2023 was $ 0 and $ 0.9 million, respectively.
The following table summarizes the activities of RSUs, PRSUs and TSR awards:
6 unchanged sentences
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.
−Removed: In September 2014, the Company adopted a 2014 ESPP that became effective on November 13, 2014.
+Added: In September 2014, the Company adopted a 2014 ESPP that became effective in November 2014.
The 2014 ESPP is designed to enable eligible employees to periodically purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15 % of their eligible compensation, subject to any plan or IRS limitations.
4 unchanged sentences
(ii) 1,200,000 shares or (iii) such number of shares as may be determined by the board of directors.
−Removed: There were 361,911 shares, 327,298 shares and 213,505 shares purchased by employees under the 2014 Purchased Plan for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: 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 2014 ESPP was suspended as of December 31, 2024.
Stock-Based Compensation
−Removed: Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense for the years ended December 31, 2023, 2022 and 2021 was as follows (in thousands):
+Added: Stock-based compensation expense was recorded directly to research and development and selling, general and administrative expense for the years the years ended December 31, 2024 and 2023 was as follows (in thousands):
Years Ended December 31,
79 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: In January 2013, FibroGen Cayman entered into a $ 0.6 million convertible promissory note.
−Removed: The note bears simple interest at a rate of two percent ( 2.00 %) per annum, accrued on an annual basis in arrears.
−Removed: The outstanding principal balance and unpaid accrued interest on the note is due and payable upon the earlier of (a) the effectiveness of the initial public offering of FibroGen Cayman or (b) the eight year anniversary of the date of the note.
−Removed: During the year ended December 31, 2021, at the option of the lender, the $ 0.7 million total outstanding principal balance and unpaid accrued interest on the note were converted into Series A Preferred Stock of FibroGen Cayman, and was recorded as an addition to the non-controlling interest of the Company.
Non-Controlling Interests
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 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 the subsidiary.
−Removed: For the nonredeemable NCI and redeemable NCI resulting from the acquisition of Fortis during the year ended December 31, 2023, see Note 4, Exclusive License and Option to Acquire Fortis Therapeutics , for details.
+Added: 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.
Net Loss Per Share
13 unchanged sentences
Total deferred
−Removed: Total provision for income taxes
+Added: Benefit from income taxes
The following is the reconciliation between the statutory federal income tax rate and the Company’s effective tax rate:
23 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 $ 57.0 million , $ 68.2 million and $ 72.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: The valuation allowance increased by $ 26.4 million and $ 66.8 million for the years ended December 31, 2024 and 2023, respectively.
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.
6 unchanged sentences
The federal credits begin to expire in 2025 and the California research credits have no expiration dates.
−Removed: Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership change” for tax purposes, as defined in IRC Section 382.
−Removed: The Company did not perform an IRC Section 382 analysis and any previous ownership changes may result in a limitation that will reduce the total amount of net operating loss and tax credit carryforwards disclosed that can be utilized.
−Removed: Subsequent ownership changes may affect the limitation in future years.
−Removed: On August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law.
−Removed: Among other changes to the Internal Revenue Code, the IRA imposes a 15 % corporate alternative minimum tax on certain corporations and 1 % excise tax on public company stock buybacks for tax years beginning after December 31, 2022.
−Removed: The tax provisions in the IRA did not have a material impact on the Company’s consolidated financial statements and related disclosures.
+Added: Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership change” for tax purposes, as defined in Internal Revenue Code (“IRC”) Section 382.
+Added: The Company performed an IRC Section 382 analysis and has determined that there were no ownership changes as of December 31, 2024.
+Added: Thus, IRC Section 382 will not limit the use of the Company’s net operating loss and tax credit carryforwards.
+Added: The Company will continue to monitor trading activities in its shares which could cause ownership change in future years.
Uncertain Tax Positions
2 unchanged sentences
The interest accrued as of December 31, 2024 and 2023 was immaterial .
−Removed: A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the three years ended December 31, 2023 is as follows (in thousands):
+Added: A reconciliation of the beginning and ending amounts of unrecognized income tax benefits during the two years ended December 31, 2024 is as follows (in thousands):
Federal and State
4 unchanged sentences
Balance as of December 31, 2023
−Removed: Increase due to prior positions
−Removed: Increase due to current year position
−Removed: Foreign exchange rate differential
−Removed: Balance as of December 31, 2022
Decrease due to prior positions
12 unchanged sentences
The Company is not currently under audit in any tax jurisdiction.
−Removed: Related Party Transactions
−Removed: Astellas is an equity investor in the Company and considered a related party.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company recorded license and development revenue related to collaboration agreements with Astellas of $ 6.7 million , $ 32.5 million , and $ 130.4 million , respectively.
−Removed: During the years ended December 31, 2023, 2022 and 2021, the Company also recorded drug product revenue from Astellas of $ 18.8 million , $ 11.1 million , and $ 3.2 million , respectively.
−Removed: See Note 3, Collaboration Agreements, License Agreement and Revenues , for details.
−Removed: The Company’s expense related to collaboration agreements with Astellas was immaterial for each of the three years ended December 31, 2023.
−Removed: As of December 31, 2023 and 2022 , accounts receivable from Astellas were $ 0.8 million and $ 1.5 million, respectively.
−Removed: As of December 31, 2023 and 2022 , total deferred revenue from Astellas were $ 16.9 million and $ 40.3 million, respectively.
−Removed: As of December 31, 2023, the amount due to Astellas, included in accrued and other current liabilities, and other long-term liabilities, totaled $ 40.5 million.
−Removed: As of December 31, 2022 , the amount due to Astellas, included in accrued and other current liabilities, was and $ 63.9 million.
−Removed: 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.
−Removed: FibroGen Beijing owns 51.1 % of Falikang’s equity.
−Removed: See Note 5, Equity method investment - Variable Interest Entity , for details.
−Removed: For the years ended December 31, 2023, 2022 and 2021, the net product revenue from sales to Falikang were $ 89.1 million , $ 71.2 million and $ 35.6 million , respectively.
−Removed: See the Product Revenue, Net section in Note 3, Collaboration Agreements, License Agreement and Revenues , for details.
−Removed: The other income from Falikang were immaterial for each of the three years ended December 31, 2023.
−Removed: For the years ended December 31, 2023, 2022 and 2021, the investment income (loss) in Falikang was $ 2.6 million , $ 1.6 million , and $ 1.0 million , respectively.
−Removed: During the year ended December 31, 2023 , the Company received $ 2.3 million of dividend distribution from Falikang.
−Removed: As of December 31, 2023 and 2022, the Company’s equity method investment in Falikang were $ 5.3 million and $ 5.1 million , respectively.
−Removed: See Note 5, Equity method investment - Variable Interest Entity , for details.
−Removed: As of December 31, 2023 and 2022 accounts receivable, net, from Falikang were $ 5.2 million and $ 10.5 million, respectively.
Segment and Geographic Information
+Added: The Company has one operating and reporting segment which primarily focuses on the development and commercialization of novel therapeutics to treat serious unmet medical needs.
The Company has determined that the chief executive officer is the chief operating decision maker (“CODM”).
−Removed: The CODM reviews financial information presented for the Company’s various clinical trial programs as well as results on a consolidated basis.
−Removed: License revenues and development revenues received are not allocated to various programs for purposes of determining a profit measure and resource allocation decisions are made by the CODM based primarily on consolidated results.
−Removed: As such, the Company has concluded that it operates as one segment.
−Removed: Supplemental enterprise-wide information has been presented below.
+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 loss as the primary measurement.
+Added: 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: The measure of segment assets is reported on the balance sheet as total consolidated assets.
+Added: 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.
+Added: 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.
+Added: Supplemental enterprise-wide information is presented below.
Geographic Revenues
3 unchanged sentences
Total revenue
−Removed: Geographic Assets
−Removed: Property and equipment, net by geographic location are as follows (in thousands):
−Removed: United States
−Removed: Total property and equipment
−Removed: Finance lease right-of-use assets and operating lease right-of-use assets, net by geographic location are as follows (in thousands):
−Removed: United States
−Removed: Total finance lease right-of-use assets
−Removed: United States
−Removed: Total operating lease right-of-use assets
Customer Concentration
−Removed: The Company’s revenues to date have been generated from the following collaboration partners and distribution entity that individually accounted for 10% or more of the Company’s total revenue or accounts receivable:
+Added: The Company’s revenues have been generated from the following collaboration partners that individually accounted for 10% or more of the Company’s total revenue:
Percentage of Revenue
−Removed: Percentage of Accounts Receivable
Years Ended December 31,
−Removed: Falikang — Related party
−Removed: Astellas — Related party
−Removed: Substantially all direct product sales to distributors in China were made by Falikang.
−Removed: No individual distributor represented over 10% of the total revenue for the years ended December 31, 2023 and 2022.
−Removed: The aggregate accounts receivable from direct sales to distributors as of December 31, 2023 and 2022 were immaterial.
−Removed: Subsequent Event
−Removed: On February 23, 2024, the Company and AstraZeneca entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement dated July 30, 2013 (as amended).
−Removed: Pursuant to the termination and transition agreement, AstraZeneca is returning all of their non-China roxadustat rights to the Company, with the exception of South Korea, and providing certain assistance during a transition period.
−Removed: The Company’s collaboration agreement with AstraZeneca for roxadustat in China remains in place.
−Removed: As a part of this termination and transition agreement, the Company and AstraZeneca will settle the outstanding balances relating to past transactions related to manufacturing and 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.
−Removed: Neither party incurred any early termination penalties.
−Removed: The Company is currently evaluating the accounting impact of this transaction as it relates to the first quarter of 2024.
Valuation an d Qualifying Accounts
3 unchanged sentences
Year ended December 31, 2023
−Removed: Year ended December 31, 2021
−Removed: Allowances for rebates, discounts and adjustments
−Removed: Year ended December 31, 2023
−Removed: Year ended December 31, 2022
−Removed: Year ended December 31, 2021
CHANGES IN AND DISAGREEMENTS WITH ACCOU NTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
19 unchanged sentences
Changes in Internal Control over Financial Reporting
−Removed: 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 most recent fiscal quarter ended December 31, 2023 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
+Added: 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, 2024 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
OTHER INFORMATION
6 unchanged sentences
The information, if any, required by this item regarding compliance with Section 16(a) of the Securities Exchange Act of 1934, as amended, is incorporated by reference to the section titled “Delinquent Section 16(a) Reports” appearing in our 2025 Proxy Statement.
+Added: Insider Trading Policy
+Added: We have adopted an Insider Trading Policy governing the purchase, sale and/or other dispositions of our securities by our directors, officers and employees.
+Added: A copy of the Insider Trading Policy is filed as an exhibit to this Annual Report on Form 10-K.
+Added: In addition, it is our practice to comply with the applicable laws and regulations relating to insider trading.
Code of Conduct
−Removed: We have adopted a Code of Business Conduct that applies to all of our directors, officers and employees.
−Removed: A copy of our Code of Business Conduct can be found on our website ( www.FibroGen.com ) under “Corporate Governance.” The contents of our website are not a part of this report.
+Added: We have adopted a Code of Business Conduct and Ethics that applies to all of our directors, officers and employees.
+Added: 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.
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.
6 unchanged sentences
PRINCIPAL ACCOU NTANT FEES AND SERVICES
−Removed: The information required by this item is incorporated by reference to the proposal title “Proposal 3 - Ratification of Selection of Independent Registered Public Accounting Firm” appearing in our 2024 Proxy Statement.
+Added: The information required by this item is incorporated by reference to the proposal titled “Proposal 3 - Ratification of Selection of Independent Registered Public Accounting Firm” appearing in our 2025 Proxy Statement.
EXHIBITS AND FINA NCIAL STATEMENT SCHEDULES
19 unchanged sentences
FibroGen, Inc.
−Removed: Amended and Restated 2005 Stock Plan.
−Removed: Forms of stock option agreement, restricted stock purchase agreement and stock appreciation right agreement under the FibroGen, Inc.
−Removed: Amended and Restated 2005 Stock Plan.
−Removed: Form of stock option agreement under the FibroGen, Inc.
−Removed: Amended and Restated 2005 Stock Plan applicable to options exchanged pursuant to FibroGen, Inc.’s 2010 amendment and exchange offer.
−Removed: Form of 2010 amendment to the form of stock option agreement under the FibroGen, Inc.
−Removed: Amended and Restated 2005 Stock Plan applicable to options amended pursuant to FibroGen, Inc.’s 2010 amendment and exchange offer.
−Removed: Form of 2013 amendment to the form of stock option agreement under the FibroGen, Inc.
−Removed: Amended and Restated 2005 Stock Plan applicable to options amended or exchanged pursuant to FibroGen, Inc.’s 2010 amendment and exchange offer.
+Added: 2024 Equity Incentive Plan.
+Added: Form of Restricted Stock Unit Grant Notice and Award Agreement.
+Added: Form of Stock Option Grant Notice and Option Agreement.
FibroGen, Inc.
3 unchanged sentences
FibroGen, Inc.
−Removed: Non-Employee Director Compensation Policy, as amended.
+Added: Non-Employee Director Compensation Policy, as amended, dated April 22, 2024.
FibroGen, Inc.
−Removed: Lease Agreement by and between FibroGen, Inc.
−Removed: and X-4 Dolphin LLC, dated as of September 22, 2006;
−Removed: as amended by First Amendment to Lease by and between FibroGen, Inc.
−Removed: and X-4 Dolphin LLC, dated as of October 10, 2007;
−Removed: as amended by Second Amendment to Lease by and between FibroGen, Inc.
−Removed: and X-4 Dolphin LLC, dated as of June 29, 2009;
−Removed: as amended by Third Amendment to Lease by and between FibroGen, Inc.
−Removed: and Are-San Francisco No.
−Removed: 43, LLC (as successor in interest to X-4 Dolphin LLC), dated as of May 19, 2011;
−Removed: as amended by Fourth Amendment to Lease by and between FibroGen, Inc.
−Removed: and Are-San Francisco No.
−Removed: 43, LLC, dated as of September 8, 2011.
+Added: FibroGen Insider Trading and Trading Window Policy, amended and restated as of November 2021.
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.
17 unchanged sentences
and Astellas Pharma Inc., dated as of May 10, 2012.
−Removed: Amended and Restated License, Development and Commercialization Agreement (China) by and among FibroGen China Anemia Holdings, Ltd., Beijing FibroGen Medical Technology Development Co., Ltd., FibroGen International (Hong Kong) Limited and AstraZeneca AB, effective as of July 30, 2013.
−Removed: Amended and Restated License, Development and Commercialization Agreement (for the U.S.
−Removed: and Certain Other Territories) by and between FibroGen, Inc.
−Removed: and AstraZeneca AB, effective as of July 30, 2013.
−Removed: Research and Commercialization Agreement by and among FibroGen, Inc., GenPharm International Inc., Medarex, Inc.
−Removed: and FibroPharma, Inc., effective as of July 9, 1998.
−Removed: Amendment No.
−Removed: 1 to Research and Commercialization Agreement by and among FibroGen, Inc., GenPharm International Inc., Medarex, Inc.
−Removed: and FibroPharma, Inc., effective as of June 30, 2001.
−Removed: Amendment No.
−Removed: 2 to Research and Commercialization Agreement by and among FibroGen, Inc., GenPharm International Inc., Medarex, Inc.
−Removed: and FibroPharma, Inc., effective as of January 28, 2002.
Form of Indemnity Agreement by and between FibroGen, Inc.
and its directors and officers.
−Removed: State-Owned Construction Land Use Right Granting Contract by and between FibroGen (China) Medical Technology Development Co., Ltd.
−Removed: and The Bureau of Land and Resources of Cangzhou, dated as of February 24, 2017 .
Commercial Supply Agreement by and between FibroGen, Inc.
6 unchanged sentences
Amendment No.
−Removed: 1 to the Amended and Restated License, Development and Commercialization Agreement by and between FibroGen, Inc.
−Removed: and AstraZeneca AB, effective July 1, 2020 .
−Removed: Amendment No.
2 to Master Supply Agreement by and among FibroGen, Inc., Shanghai SynTheAll Pharmaceutical Co., Ltd.
and STA Pharmaceutical Hong Kong Limited, effective July 24, 2020 .
−Removed: Master Supply Agreement by and between FibroGen, Inc.
−Removed: and AstraZeneca UK Limited, effective September 10, 2020 .
−Removed: Master Services Agreement by and between FibroGen, Inc.
−Removed: and Samsung Biologics Co., Ltd., effective as of October 30, 2020.
−Removed: Product Specific Agreement by and between FibroGen, Inc.
−Removed: and Samsung Biologics Co., Ltd., effective as of October 30, 2020.
Astellas EU Supply Agreement by and between FibroGen, Inc.
2 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: Sixth Amendment to the Lease by and between ARE-San Francisco No., 43, LLC and FibroGen, Inc.
−Removed: as of June 1, 2021.
Exclusive License and Option Agreement by and between FibroGen, Inc.
and HiFiBiO (HK) Limited (D.B.A.
−Removed: HiFiBiO Therapeutics), as of June 16, 2021.
+Added: HiFiBiO Therapeutics), dated as of June 16, 2021.
Amendment No.
2 unchanged sentences
and Christine Chung, dated as of June 17, 2008.
−Removed: Offer Letter by and between FibroGen, Inc.
−Removed: and Juan Graham, effective as of July 30, 2021.
+Added: Amendment No.1 to the Exclusive License and Option Agreement, between HiFiBiO Inc.
+Added: and FibroGen, Inc., dated February 14, 2024.
Form of Executive Officer Change in Control and Severance Agreement .
−Removed: Amended and Restated Exclusive License Agreement by and between FibroGen, Inc.
−Removed: and Eluminex Biosciences (Suzhou) Limited as of January 21, 2022.
−Removed: Amended and Restated Equity Distribution Agreement by and between FibroGen, Inc.
−Removed: and Goldman Sachs & Co.
−Removed: LLC and BofA Securities, Inc., dated February 27, 2023.
−Removed: Amendment No.
−Removed: 1 to Product Specific Agreement - Clinical Product Drug Substance by and between FibroGen, Inc.
−Removed: and Samsung Biologics Co., Ltd., effective as of October 25, 2022.
+Added: ATM Equity Offering Sales Agreement, by and between FibroGen, Inc.
+Added: and BofA Securities, Inc., dated as of February 24, 2025.
Revenue Interest Financing Agreement by and between FibroGen, Inc.
6 unchanged sentences
and Thane Wettig.
−Removed: Consulting Agreement, dated July 23, 2023, between FibroGen, Inc.
−Removed: and Enrique Conterno.
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.
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.
−Removed: Evaluation Agreement by and between FibroGen, Inc.
−Removed: and Fortis Therapeutics, Inc., dated May 5, 2023.
−Removed: Option Agreement and Plan of Merger by and among FibroGen, Inc., Fortis Therapeutics, Inc., and Shareholder Representative Services LLC, dated as of May 5, 2023.
−Removed: Consulting Agreement, dated September 11, 2023, between FibroGen, Inc.
−Removed: and Mark Eisner.
+Added: First Amended and Restated Evaluation Agreement by and between FibroGen, Inc.
+Added: and Fortis Therapeutics, Inc., dated June 6, 2024.
+Added: 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.
Amendment No.
−Removed: 1 to the Second Amended and Restated Exclusive License Agreement, dated as of November 16, 2023.
+Added: 1 to the Second Amended and Restated Exclusive License Agreement, by and between FibroGen (China) Medical Technology Development Co., Ltd.
+Added: and Eluminex Biosciences (Suzhou) Limited, dated as of November 16, 2023.
+Added: Termination and Transition Agreement to Development and Commercialization Agreement (for the U.S.
+Added: and Certain Other Territories), by and between AstraZeneca AB and FibroGen, Inc., dated February 25, 2024.
Subsidiaries of FibroGen, Inc.
20 unchanged sentences
FIBROGEN, INC.
−Removed: February 26, 2024
+Added: March 17, 2025
/s/ Thane Wettig
1 unchanged sentence
(Principal Executive Officer)
−Removed: February 26, 2024
−Removed: /s/ Juan Graham
+Added: March 17, 2025
+Added: /s/ David DeLucia
+Added: David DeLucia
Senior Vice President and Chief Financial Officer
1 unchanged sentence
POWER OF ATTORNEY
−Removed: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Thane Wettig and Juan Graham, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.
+Added: KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Thane Wettig and David DeLucia, jointly and severally, his or her attorneys-in-fact, each with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
2 unchanged sentences
(Principal Executive Officer)
−Removed: February 26, 2024
−Removed: /s/ Juan Graham
+Added: March 17, 2025
+Added: /s/ David DeLucia
Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
−Removed: February 26, 2024
+Added: March 17, 2025
+Added: David DeLucia
Chairman of the Board and Director
−Removed: February 26, 2024
−Removed: /s/ Suzanne Blaug
−Removed: February 26, 2024
−Removed: Suzanne Blaug
+Added: March 17, 2025
/s/ Aoife Brennan
−Removed: February 26, 2024
+Added: March 17, 2025
Aoife Brennan, M.B., B.Ch.
−Removed: /s/ Benjamin F.
−Removed: February 26, 2024
−Removed: Cravatt, Ph.D.
/s/ Jeffrey L.
−Removed: February 26, 2024
−Removed: /s/ Jeffrey W.
−Removed: February 26, 2024
+Added: March 17, 2025
/s/ Maykin Ho
−Removed: February 26, 2024
+Added: March 17, 2025
Maykin Ho, Ph.D.
−Removed: /s/ Gerald Lema
−Removed: February 26, 2024
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.