What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-10 compared with 2025-08-11 · 178 added, 179 removed, 288 unchanged (55% of the section changed)

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This program also includes the development of FG-3180, an associated CD46-targeted positron emission tomography (“PET”) biomarker and imaging agent.

We anticipate initiation of a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory analysis of FG-3180, in the third quarter of 2025.

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.

On February 20, 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.

agreed to sell all of the issued and outstanding equity interests of FibroGen International (Hong Kong) Ltd.

(“FibroGen International”) to AstraZeneca Treasury Limited.

AstraZeneca AB (“AstraZeneca”) is our long-time commercialization partner for roxadustat in greater China and South Korea.

This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd.

(“FibroGen Beijing”) and its 51.1% interest in Beijing Falikang Pharmaceutical Co., Ltd.

(“Falikang”).

The transaction is expected to close in the third quarter of 2025, and is subject to customary closing conditions and closing deliverables, including receipt of regulatory approval from the China State Administration for Market Regulation (“SAMR”).

We initiated a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC, along with the exploratory analysis of FG-3180, in the third quarter of 2025.

We and our collaboration partners developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in the People’s Republic of China (“China”), Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (“CKD”) patients on dialysis and not on dialysis.

On August 29, 2025, we closed the sale of our China operations through FibroGen International (Hong Kong) Ltd.

(“FibroGen International”) to AstraZeneca Treasury Limited pursuant to the share purchase agreement entered into by the Company and AstraZeneca Treasury Limited on February 20, 2025, as amended (“Share Purchase Agreement”) for a total consideration of $220.4 million comprised of $85.0 million in enterprise value and $135.4 million in net cash held in China.

AstraZeneca AB (“AstraZeneca”) was our long-time commercialization partner for roxadustat in greater China.

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

FibroGen has retained the rights to roxadustat in the United States of America (“U.S.”), Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas Pharma Inc.

(“Astellas”).

Roxadustat is not approved for commercialization in any indication in the U.S., Canada, or Mexico.

Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements:

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We had a positive Type-C meeting with the U.S.

Food and Drug Administration (“FDA”) in July 2025 and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS.

Food and Drug Administration (“FDA”) in July 2025 and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, including the starting dose and the inclusion criteria.

We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.

We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of 2025.

Financial Highlights

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands, except for per share data)

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Loss from continuing operations per share - basic and diluted

June 30, 2025

September 30, 2025

December 31, 2024

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Accounts receivable

Our revenue for the three and six months ended June 30, 2025 included primarily the drug product revenue of $1.2 million and $3.8 million, respectively, related to active pharmaceutical ingredient (“API”) deliveries to Astellas.

As a comparison, our revenue for the three and six months ended June 30, 2024 included primarily the revenue recognized related to the following, respectively:

• $0.7 million and a net reduction of $0.5 million to drug product revenue related to API deliveries to Astellas;

in addition, $25.7 million cumulative catch-up net adjustment in the drug product revenue, for the six months ended June 30, 2024, as a result of terminating the AstraZeneca U.S./RoW Agreement, effective in February 2024 (“AstraZeneca Termination and Transition Agreement”), with the exception of South Korea;

Long-term investments

Our revenue for the three and nine months ended September 30, 2025 included primarily the drug product revenue of $1.0 million and $4.8 million, respectively, related to active pharmaceutical ingredient (“API”) deliveries to Astellas.

As a comparison, our revenue for the three and nine months ended September 30, 2024 included primarily the revenue recognized related to the following, respectively:

• A net reduction of $0.3 million and $0.7 million to drug product revenue related to API deliveries to Astellas;

in addition, $25.7 million cumulative catch-up net adjustment in the drug product revenue, for the nine months ended September 30, 2024, as a result of terminating the AstraZeneca U.S./RoW Agreement (as defined below), effective in February 2024 (“AstraZeneca Termination and Transition Agreement”), with the exception of South Korea;

• $0.4 million and $1.5 million of development and other revenue recognized mainly under our collaboration agreements with our partners Astellas and AstraZeneca.

Operating costs and expenses for the three and six months ended June 30, 2025 decreased compared to the same periods a year ago primarily as a result of the net effect of the following, respectively:

• $12.8 million and $24.3 million lower employee-related expenses primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

Operating costs and expenses for the three and nine months ended September 30, 2025 decreased compared to the same periods a year ago primarily as a result of the net effect of the following, respectively:

• $18.6 million restructuring charge recorded in the third quarter of 2024 related to the reduction in force plan in August 2024, which did not recur in the current year period;

• $7.7 million and $22.9 million lower facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;

• $6.9 million and $12.7 million lower stock-based compensation primarily resulting from significant lower stock price and cancellations of stock options and restricted stock units due to reduced headcount;

• $5.9 million and $18.6 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 and terminations;

• $4.4 million and $14.9 million lower clinical trial expenses primarily associated with the termination of pamrevlumab programs during the second half of 2024 responding to the topline clinical data results we reported in July 2024;

• $1.7 million and $6.8 million lower drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated;

• $21.1 million one-time cost of goods sold recorded for the six months ended June 30, 2024 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.

For the three months ended June 30, 2025, we had a loss from continuing operations of $13.7 million, or a loss per basic and diluted share of $3.38, as compared to a loss of $47.1 million, or a loss per basic and diluted share of $11.79, for the same period a year ago, due to decreases in operating costs and expenses as discussed above.

For the six months ended June 30, 2025, we had a loss from continuing operations of $30.4 million, or a loss per basic and diluted share of $7.54, as compared to a loss of $96.1 million, or a loss per basic and diluted share of $24.18, for the same period a year ago, due to decreases in operating costs and expenses offset by decreases in revenue as discussed above.

Cash and cash equivalents and accounts receivable for continuing operations totaled $23.5 million at June 30, 2025, a decrease of $27.5 million from December 31, 2024.

Consolidated cash and cash equivalents and accounts receivable for both continuing operations and discontinued operations totaled $142.1 million at June 30, 2025, an increase of $21.0 million from December 31, 2024, primarily due to the cash provided by operations as discussed under the Liquidity and Capital Resources section below.

• $0.8 million and $25.0 million lower employee-related expenses primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• $21.1 million one-time cost of goods sold recorded for the nine months ended September 30, 2024 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.

For the three months ended September 30, 2025, we had a loss from continuing operations of $13.1 million, or a loss per basic and diluted share of $3.25, as compared to a loss of $48.3 million, or a loss per basic and diluted share of $12.01, for the same period a year ago, due to decreases in operating costs and expenses as discussed above.

For the nine months ended September 30, 2025, we had a loss from continuing operations of $43.6 million, or a loss per basic and diluted share of $10.79, as compared to a loss of $144.4 million, or a loss per basic and diluted share of $36.19, for the same period a year ago, due to decreases in operating costs and expenses offset by decreases in revenue as discussed above.

Cash and cash equivalents, investments and accounts receivable totaled $121.1 million at September 30, 2025, an increase of $70.2 million from December 31, 2024.

Upon the the close of our sale of FibroGen International to AstraZeneca Treasury Limited during the third quarter of 2025, we accessed the entirety of our cash and cash equivalents held in China.

Consolidated cash and cash equivalents and accounts receivable for both continuing operations and discontinued operations totaled $121.1 million at December 31, 2024.

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statement, and the Liquidity and Capital Resources section below.

Commercial, Development and Research Programs

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Treatment choice in first and second line mCRPC significantly depends on patients’ prior treatments.

Androgen receptor signaling inhibitors (“ARSIs”) and chemotherapy are the preferred treatments in patients who have not been exposed to either in earlier lines of therapy.

Most patients previously treated with an ARSI for metastatic hormone-sensitive prostate cancer receive chemotherapy in first-line mCRPC.

Rechallenge with an alternative ARSI is associated with limited benefit in this setting.

Androgen receptor signaling inhibitors or androgen receptor pathway inhibitors (“ARSIs”/“ARPIs”, often used interchangeably) and chemotherapy are the preferred treatments in patients who have not been exposed to either in earlier lines of therapy.

Most patients previously treated with an ARSI/ARPI for metastatic hormone-sensitive prostate cancer will then receive chemotherapy in first-line mCRPC.

Rechallenge with an alternative ARSI/ARPI is associated with limited benefit in this setting.

For the 25-30% of patients with homologous recombination repair mutation, poly (ADP-ribose) polymerase inhibitors are the standard of care for mCRPC patients.

Recent approvals of prostate-specific membrane antigen (“PSMA”)-targeted radiopharmaceuticals in the post-ARSI and post-chemotherapy setting have diversified treatment options in advanced mCRPC.

Recent approvals of prostate-specific membrane antigen (“PSMA”)-targeted radiopharmaceuticals in the post-ARPI and post-chemotherapy setting have diversified treatment options in advanced mCRPC.

Furthermore, PSMA-PET has been validated as standard of care diagnostic in prostate cancer, while LOCAMETZ or an approved PSMA-11 imaging agent are approved to select patients for treatment with Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

FibroGen is developing FG-3246 in the post-ARSI, pre-chemotherapy mCRPC setting.

This is an area of high unmet need, where radiographic progression free survival is approximately 5.6-6 months after switching to a different ARSI, and approximately 8 months with chemotherapy.

FibroGen is developing FG-3246 in the post-ARPI, pre-chemotherapy mCRPC setting.

This is an area of high unmet need, where radiographic progression free survival is approximately 5.6-6 months after switching to a different ARPI, and approximately 8 months with chemotherapy.

Novel mechanisms of action that extend survival are critical in this setting as well as biomarker driven treatment approaches.

FG-3246 and the potential patient selection biomarker FG-3180 are being developed to address these unmet medical needs.

FG-3246 and FG-3180 for the Treatment of mCRPC

Phase 2 Monotherapy Clinical Trial of FG-3246 and FG-3180 for the Treatment of mCRPC

We are developing FG-3246 in mCRPC and exploring other potential cancer indications.

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The cytotoxic payload of FG-3246 is monomethyl auristatin E (“MMAE”), an anti-mitotic agent that has been utilized in four commercially approved ADC drugs.

We have met with the FDA to discuss the development pathway of FG-3246, and we anticipate initiation of a Phase 2 monotherapy dose optimization study of FG-3246 for the treatment of mCRPC in the third quarter of 2025, pending close of the sale of FibroGen International to AstraZeneca Treasury Limited.

As part of this Phase 2 study, patients will also receive FG-3180, our PET imaging agent.

FG-3180 is a diagnostic radiopharmaceutical utilizing a radiolabeled version of our CD46 targeting antibody in FG-3246 to assess the correlation between CD46 expression and the response to FG-3246.

We initiated a Phase 2 monotherapy, dose-optimization study of FG-3246 for the treatment of mCRPC in the third quarter of 2025, with interim results expected in the second half of 2026.

The trial is also assessing the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246.

The ability of FG-3180 to identify mCRPC lesions and predict response to FG-3246 is being evaluated .

The Phase 2 monotherapy trial ( NCT06842498 ) is a randomized, open label, dose optimization trial designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246 for the treatment of patients with mCRPC who have progressed following ARPI treatment and who have not received chemotherapy for their mCRPC.

The trial is scheduled to enroll 75 patients who will be randomized 1:1:1 to receive either 1.8, 2.4 or 2.7 mg/kg AJBW of FG-3246.

The primary endpoint of the trial is the determination of the optimal dose for the Phase 3 trial based on efficacy, safety, and PK parameters.

Secondary endpoints include radiographic progression free survival (rPFS), prostate-specific antigen (PSA) 50 response, and PSA90 response.

An interim analysis is planned once 12 patients enrolled in each of the three dose arms have completed 12 weeks on study or discontinued and is anticipated in the second half of 2026.

An exploratory sub-study will evaluate FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical.

All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization.

Prior Studies of FG-3246 and FG-3180 for the Treatment of mCRPC

In March 2025, FibroGen announced the peer-reviewed publication titled “A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer” in the Journal of Oncology.

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The presentation includes data from 17 biomarker unselected patients in the dose escalation portion of the trial.

Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment.

Over 70% of the patients in the study received at least two prior ARPIs, which included prior enzalutamide treatment.

Dose escalation was explored with and without prophylactic granulocyte colony-stimulating factor (“G-CSF”) support.

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The most frequent adverse events were consistent with other MMAE-based ADCs and included fatigue, weight loss, elevated transaminases, neutropenia, and peripheral neuropathy.

We expect topline results from the Phase 2 portion of this study, including data on the CD46 targeted PET imaging agent FG-3180, in the fourth quarter of 2025.

We expect topline results from the Phase 2 portion of this study in the first quarter of 2026.

ROXADUSTAT IN ANEMIA ASSOCIATED WITH MYELODYSPLASTIC SYNDROMES

FibroGen maintains its rights to roxadustat in the United States and in all markets not licensed to Astellas.

We had a positive Type-C meeting with the FDA in July 2025, and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, a high-value indication with significant unmet medical needs.

Our planned Phase 3 trial will assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with lower-risk MDS.

At our Type-C meeting, we aligned with the FDA on the patient population (patients requiring ≥ 4 packed Red Blood Cell (“RBC”) units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (“ESA”) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility, dose modification, and discontinuation criteria.

As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC transfusion independence.

FibroGen maintains its rights to roxadustat in the U.S.

and in all markets not licensed to Astellas.

We had a positive Type-C meeting with the FDA in July 2025, and reached alignment on several elements of our proposed Phase 3 study design for roxadustat in anemia associated with lower-risk MDS, including the starting dose and the inclusion criteria.

We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program.

We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of 2025.

The planned Phase 3 trial will assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with lower-risk MDS.

Alignment was reached with the FDA on the patient population (patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria.

As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI.

MDS are a diverse group of bone marrow disorders characterized by ineffective production of healthy blood cells and premature destruction of blood cells in the bone marrow, leading to anemia.

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Roxadustat in Anemia of Chronic Kidney Disease

Roxadustat is our commercial-stage product, an oral small molecule inhibitor of HIF-PH activity that acts by stimulating the body’s natural pathway of erythropoiesis, or red blood cell production.

In collaboration with our partners Astellas and AstraZeneca, roxadustat (爱瑞卓 ® , EVRENZO TM ) is approved to treat anemia in China, Europe, Japan, and numerous other countries.

We and our collaboration partners developed roxadustat (爱瑞卓 ® , EVRENZO TM ), which is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis.

China – Roxadustat Commercial Program

On February 20, 2025, we and our subsidiary FibroGen China Anemia Holdings, Ltd.

entered into a Share Purchase Agreement with AstraZeneca Treasury Limited, a subsidiary of AstraZeneca plc, pursuant to which we agreed to sell all of the issued and outstanding equity interests of FibroGen International for an aggregate purchase price 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, currently estimated to be approximately $125 million, as of the closing, which totals an aggregate amount of approximately $210 million.

This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1% interest in Falikang.

AstraZeneca is our long-time commercialization partner for roxadustat in greater China and South Korea.

Upon the closing, we will assign to them all rights to roxadustat in China, Hong Kong, and Macao, including rights to manufacture, develop, distribute, and commercialize roxadustat.

On August 29, 2025, we closed the sale of our China operations through FibroGen International (Hong Kong) Ltd.

(“FibroGen International”) to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement for a total consideration of $220.4 million comprised of $85.0 million in enterprise value and $135.4 million in net cash held in China.

This sale included all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen (China) Medical Technology Development Co., Ltd (“FibroGen Beijing”) and its 51.1% interest in Beijing Falikang Pharmaceutical Co., Ltd.

(“Falikang”).

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements .

U.S., Europe, Japan and Rest of World - Roxadustat Program

FibroGen has retained the rights to roxadustat in the U.S., Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas.

Roxadustat is not approved for commercialization in any indication in the U.S., Canada, or Mexico.

Astellas is commercializing roxadustat (EVRENZO TM ) in Europe and Japan to treat anemia under two development and commercialization license agreements:

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If FibroGen chooses not to acquire Fortis, its exclusive license to FG-3246 would expire.

On March 28, 2025, the Company and Fortis entered into amendments and modified the option exercise deadline to December 31, 2027.

For additional details about this transaction, see the Consolidated Variable Interest Entity - Fortis section in Note 4, Variable Interest Entities , to the condensed consolidated financial statements.

Exclusive License from HiFiBiO

In June 2021, we entered into an exclusive license and option agreement with HiFiBiO (HK) Ltd.

HiFiBiO Therapeutics) (“HiFiBiO”), pursuant to which we exclusively licensed from HiFiBiO all product candidates in HiFiBiO’s Galectin-9 program and subsequently exclusively licensed all product candidates in HiFiBiO’s CCR8 program.

On June 12, 2025, FibroGen entered into a termination, asset transfer and license Agreement with HiFiBiO (“HiFiBiO Termination, Asset Transfer and License Agreement”), which terminated the exclusive license and option agreement and all rights and obligation of FibroGen thereunder ceased.

Under the HiFiBiO Termination, Asset Transfer and License Agreement, FibroGen licensed HiFiBiO the anti-CCR8 and anti-Gal-9 intellectual property developed by FibroGen.

In the event HiFiBiO sublicenses the Gal-9 (FG-3165) and/or CCR8 (FG-3175) assets, FibroGen is eligible to receive a mid single-digit to low double-digit share of HiFiBiO’s license revenues and low double-digit share of HiFiBiO’s commercial royalties.

In the case HiFiBiO commercializes either asset, FibroGen has the potential to receive single-digit royalties based upon worldwide net sales.

Exclusive License to Eluminex

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).

See the Eluminex Agreement section in Note 3, Collaboration Agreements, License Agreement and Revenues, to the condensed consolidated financial statements for details.

On August 5, 2025, FibroGen accepted the assignment and delegation from FibroGen Hong Kong, FibroGen Beijing, and Falikang of their respective rights and obligations under the A&R Eluminex Agreement.

Collaboration Partnerships for Roxadustat

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In April 2006, we entered into a separate collaboration agreement with Astellas for roxadustat for the treatment of anemia in Europe, the Commonwealth of Independent States, the Middle East, and South Africa (“Astellas Europe Agreement”).

Under these agreements, the aggregate amount of consideration received through June 30, 2025 totaled $790.1 million.

Under these agreements, the aggregate amount of consideration received through September 30, 2025 totaled $790.1 million.

Based on the current development plans for roxadustat in Japan and Europe, we do not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement or the Astellas Europe Agreement.

In 2018, we and Astellas entered into an amendment to the Astellas Japan Agreement that allows Astellas to manufacture roxadustat drug product for commercialization in Japan (the “Astellas Japan Amendment”).

The related drug product revenue was immaterial for the three months ended June 30, 2025.

The related drug product revenue was $(0.4) million for the three months ended June 30, 2024, and $1.8 million and $(2.6) million for the six months ended June 30, 2025 and 2024, respectively.

The related drug product revenue was $(0.4) million and $(1.4) million for the three months ended September 30, 2025 and 2024, and $1.4 million and $(3.9) million for the nine months ended September 30, 2025 and 2024, respectively.

During the first quarter of 2021, we entered into an EU Supply Agreement with Astellas under the Astellas Europe Agreement to define general forecast, order, supply and payment terms for Astellas to purchase roxadustat bulk drug product from FibroGen in support of commercial supplies (the “Astellas EU Supply Agreement”).

The related drug product revenue was $1.2 million and $1.1 million for the three months ended June 30, 2025 and 2024, and $2.0 million and $2.1 million for the six months ended June 30, 2025 and 2024, respectively.

The related drug product revenue was $1.3 million and $1.1 million for the three months ended September 30, 2025 and 2024, and $3.3 million and $3.2 million for the nine months ended September 30, 2025 and 2024, respectively.

In July 2013, we entered into a collaboration agreement with AstraZeneca for roxadustat for the treatment of anemia in the U.S.

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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.

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.

On February 25, 2024, we entered into an agreement to terminate the AstraZeneca U.S./RoW Agreement with AstraZeneca, as amended and restated on August 29, 2025.

Pursuant to the AstraZeneca Termination and Transition Agreement, AstraZeneca returns all of their non-China roxadustat rights to us, with the exception of South Korea, and provides certain assistance during a transition period.

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Accordingly, during the first quarter of 2024, we recorded a cumulative catch-up net adjustment of $25.7 million to the drug product revenue.

AstraZeneca was our long-time commercialization partner for roxadustat in greater China.

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”).

Under the AstraZeneca agreements, the aggregate amount of consideration received through June 30, 2025 totaled $81.2 million.

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 (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 .

Under the AstraZeneca agreements, the aggregate amount of consideration received through September 30, 2025 totaled $81.2 million.

On August 29, 2025, we closed the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement.

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

AstraZeneca China Amendment

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Our proportionate share of the reported profits or losses of Falikang, is included in the discontinued operations in the condensed consolidated statement of operations, and the investment in unconsolidated subsidiary is included the held for sale assets on the condensed consolidated balance sheet.

See Note 2, Discontinued Operations , to the condensed consolidated financial statements for details.

See Note 2, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details.

Product revenue, net, which is included in the discontinued operations, consists primarily of revenues from sales of roxadustat commercial product to Falikang.

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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.

We recognized net product revenue of $19.7 million and $49.6 million for the three months ended June 30, 2025 and 2024, and $59.5 million and $80.2 million for the six months ended June 30, 2025 and 2024, respectively, majority of which were from the sales to Falikang.

As discussed in Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements, the divestiture of FibroGen International was completed on August 29, 2025 and accordingly, the performance obligation to AstraZeneca was completely satisfied upon the closing of the divestiture.

As a result, all the previously deferred revenues were recognized as revenue during the three months ended September 30, 2025.

We recognized net product revenue of $167.2 million and $46.2 million for the three months ended September 30, 2025 and 2024, and $226.7 million and $126.4 million for the nine months ended September 30, 2025 and 2024, respectively, majority of which were from the sales to Falikang.

RESULTS OF OPERATIONS

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

(dollars in thousands)

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We recognize development services as revenue in the period in which they are billed to our partners, excluding China.

As of June 30, 2025, we do not expect to incur significant future co-development services.

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.

As of September 30, 2025, we do not expect to incur significant future co-development services.

Other revenues consist of contract manufacturing revenue, patent transfer and sales of research and development material.

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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.

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.

The AstraZeneca U.S./RoW Agreement was terminated on February 25, 2024 (except for South Korea).

On August 29, 2025, we closed the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited pursuant to the Share Purchase Agreement.

For additional details, refer to Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

In the future, we will continue generating revenue from collaboration agreements in the form of milestone payments and royalties on drug product sales.

We expect that any revenues we generate will fluctuate from quarter to quarter due to the uncertain timing and amount of such payments and sales.

Total revenue increased $0.4 million, or 35%, for the three months ended June 30, 2025, and decreased $22.3 million, or 84%, for the six months ended June 30, 2025, respectively, compared to the same periods a year ago for the reasons discussed in the sections below.

Total revenue increased $1.0 million, or 775%, for the three months ended September 30, 2025, and decreased $21.3 million, or 81%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago for the reasons discussed in the sections below.

Drug Product Revenue, Net

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

(dollars in thousands)

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NM = Not meaningful

Drug product revenue, net increased $0.5 million, or 67%, for the three months ended June 30, 2025, and decreased $21.4 million, or 85%, for the six months ended June 30, 2025, respectively, compared to the same periods a year ago.

Drug product revenue, net increased $1.2 million, or 465%, for the three months ended September 30, 2025, and decreased $20.2 million, or 81%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago.

Astellas Japan Agreement

During the second quarter of 2025, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and the adjustment to the drug product revenue for the three months ended June 30, 2025 was immaterial.

During the third quarter of 2025, 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 $0.4 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect foreign exchange impacts, among others.

During the first quarter of 2025, we updated our estimate of variable consideration related to the API shipments fulfilled under the terms of Astellas Japan Amendment, and accordingly recorded an adjustment to the drug product revenue of $1.8 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated yield from the manufacture of bulk product tablets, among others.

During the third quarter of 2024, 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 $1.4 million.

Specifically, the change in estimated variable consideration was based on the API held by Astellas at period end, adjusted to reflect the changes in the estimated bulk product strength mix intended to be manufactured by Astellas, among others.

During the second quarter of 2024, 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 $0.4 million.

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As of June 30, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $0.6 million in accrued liabilities, representing our best estimate of the timing for these amounts to be paid.

As of September 30, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $1.0 million in accrued liabilities, representing our best estimate of the timing for these amounts to be paid.

Astellas Europe Agreement

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As of December 31, 2024, the related balance in accrued liabilities was $10.5 million.

We further reclassified $1.3 million from the related deferred revenue to accrued liabilities during the six months ended June 30, 2025.

As of June 30, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $11.9 million in accrued liabilities, representing our best estimate that these amounts will be paid within the next 12 months.

We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.2 million and $1.1 million for the three months ended June 30, 2025 and 2024, and $2.0 million and $2.1 million for the six months ended June 30, 2025 and 2024, respectively.

We further reclassified $0.9 million from the related deferred revenue to accrued liabilities during the nine months ended September 30, 2025.

As of September 30, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $11.4 million in accrued liabilities, representing our best estimate that these amounts will be paid within the next 12 month, a $7.1 million of which was paid to Astellas in October 2025.

We recognized royalty revenue as drug product revenue, from the deferred revenue under the Astellas Europe Agreement, of $1.3 million and $1.1 million for the three months ended September 30, 2025 and 2024, and $3.3 million and $3.2 million for the nine months ended September 30, 2025 and 2024, respectively.

It is our best estimate that the remainder of the deferred revenue will be recognized as revenue and when uncertainty is resolved, based on the performance of roxadustat product sales in the Astellas territory.

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Operating Costs and Expenses

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

(dollars in thousands)

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Total operating costs and expenses

NM = Not meaningful

Total operating costs and expenses decreased $34.0 million, or 72%, and decreased $90.9 million, or 75%, for the six months ended June 30, 2025, respectively, compared to the same periods a year ago for the reasons discussed in the sections below.

Total operating costs and expenses decreased $41.3 million, or 86%, and decreased $132.2 million, or 78%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago for the reasons discussed in the sections below.

Cost of Goods Sold

Cost of goods sold was immaterial for the three months ended June 30, 2025 and 2024.

Cost of goods sold decreased $21.1 million, or 98%, for the six months ended June 30, 2025, compared to the same period a year ago.

Cost of goods sold was immaterial for the three months ended September 30, 2025 and 2024.

Cost of goods sold decreased $21.1 million, or 99%, for the nine months ended September 30, 2025, compared to the same period a year ago.

As described above, during the first quarter of 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.

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in the third quarter of 2024.

As a result, research and development expenses have overall decreased and may continue to decrease in certain areas over time.

The following table summarizes our research and development expenses incurred during the three and six months ended June 30, 2025 and 2024:

Three Months Ended June 30,

Six Months Ended June 30,

As a result, research and development expenses have overall decreased.

The following table summarizes our research and development expenses incurred during the three and nine months ended September 30, 2025 and 2024:

Three Months Ended September 30,

Nine Months Ended September 30,

Product Candidate

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We allocate research and development salaries, benefits, stock-based compensation and other indirect costs to our product candidates on a program-specific basis, and we include these costs in the program-specific expenses.

Research and development expenses decreased $26.5 million, or 82%, for the three months ended June 30, 2025, and decreased $53.8 million, or 78%, for the six months ended June 30, 2025, respectively, compared to the same periods a year ago, primarily as a result of the net effect of the following:

• Decrease of $8.4 million and $16.2 million in employee-related costs primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• Decrease of $3.6 million and $10.5 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;

Research and development expenses decreased $18.8 million, or 94%, for the three months ended September 30, 2025, and decreased $72.6 million, or 82%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago, primarily as a result of the net effect of the following:

• Decrease of $7.2 million and $19.1 million in facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;

• Decrease of $3.6 million and $6.8 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;

• Decrease of $4.4 million and $14.9 million in clinical trials costs primarily associated with the termination of pamrevlumab programs during the second half of 2024 responding to the topline clinical data results we reported in July 2024;

• Decrease of $4.1 million and $11.0 million in stock-based compensation primarily resulting from significantly lower stock price and cancellations of stock options and restricted stock units due to reduced headcount and terminations;

• Decrease of $1.7 million and $6.8 million in drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated;

• Decrease of $1.0 million and $17.2 million in employee-related costs primarily due to the impact from reduction in force action in August 2024 and cost control efforts.

Selling, General and Administrative Expenses

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As a result, SG&A expenses have overall decreased and may continue to decrease over time.

SG&A expenses decreased $7.8 million, or 53%, for the three months ended June 30, 2025, and decreased $16.5 million, or 52%, for the six months ended June 30, 2025, respectively, compared to the same periods a year ago, primarily as a result of the net effect of the following, respectively:

• Decrease of $4.4 million and $8.0 million in employee-related costs primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

SG&A expenses decreased $4.1 million, or 43%, for the three months ended September 30, 2025, and decreased $20.5 million, or 50%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago, primarily as a result of the net effect of the following, respectively:

• Decrease of $1.8 million and $7.6 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;

• Decrease of $7.8 million in employee-related costs for the nine month period, primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• Decrease of $3.8 million in facilities-related expenses for the nine month period, due to cost control efforts including the lease termination in the third quarter of 2024.

Restructuring Charge

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workforce by approximately 75%.

As a result, we recorded majority of the related non-recurring restructuring charge during the third quarter of 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions.

The related restructuring charge for the three and six months ended June 30, 2025 was not material.

As a result, we recorded majority of the related non-recurring restructuring charge of $18.6 million during the third quarter of 2024, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions.

The related restructuring charges for the three and nine months ended September 30, 2025 were not material.

Interest and Other, Net

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

(dollars in thousands)

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Interest expense

Loss on debt extinguishments

Interest income and other income (expenses), net

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Interest Expense

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.

Interest expense remained relatively flat for the three and six months ended June 30, 2025, compared to the same periods a year ago.

Interest expense represents the interest related to sale of future revenues and interest related to the Technology Development Center of the Republic of Finland product development obligations.

Interest expense remained relatively flat for the three and nine months ended September 30, 2025, compared to the same periods a year ago.

Loss on debt extinguishments

On August 29, 2025, upon the above-mentioned completion of the sale of our China operations through FibroGen International to AstraZeneca Treasury Limited, we paid a total of $80.9 million to Morgan Stanley Tactical Value (“MSTV”), including $75.0 million for paying off the senior secured term loan facilities, $0.4 million for outstanding interest and $5.5 million for related premium and fees.

Accordingly, we recorded a loss on debt extinguishments of $6.6 million for the three and nine months ended September 30, 2025.

See Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements for details.

Interest Income and Other Income (Expenses), Net

Interest income and other income (expenses), net primarily include interest income earned on our cash, cash equivalents and investments, foreign currency transaction gains (losses), remeasurement of certain monetary assets and liabilities in non-functional currency of our subsidiaries into the functional currency, realized gains (losses) on sales of investments, and other non-operating income and expenses.

Interest income and other income (expenses), net decreased $0.6 million, or 68%, and decreased $2.4 million, or 78%, for the six months ended June 30, 2025, respectively, compared to the same periods a year ago, primarily due to lower interest income resulting from lower cash equivalents and investment balances.

Three Months Ended June 30,

Six Months Ended June 30,

Interest income and other income (expenses), net decreased $0.5 million, or 37%, and decreased $3.0 million, or 65%, for the nine months ended September 30, 2025, respectively, compared to the same periods a year ago, primarily due to lower interest income resulting from overall lower cash equivalents and investment balances during the current year periods.

Three Months Ended September 30,

Nine Months Ended September 30,

(dollars in thousands)

Loss from continuing operations before income taxes

Benefit from income taxes

Provision for (benefit from) income taxes

Effective tax rate

Benefits for income taxes for the three and six months ended June 30, 2025 and 2024 were primarily due to foreign taxes.

Provision for (benefits from) income taxes for the three and nine months ended September 30, 2025 and 2024 were primarily related 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.

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agreed to sell all of the issued and outstanding equity interests of FibroGen International to AstraZeneca Treasury Limited.

AstraZeneca is our long-time commercialization partner for roxadustat in greater China and South Korea.

This sale includes all of our roxadustat assets in China, including FibroGen International’s subsidiary FibroGen Beijing and its 51.1% interest in Falikang.

We determined that FibroGen International met the “held for sale” criteria and the “discontinued operations” criteria in accordance with Financial Accounting Standard Board Accounting Standards Codification ASC 205, Presentation of Financial Statements , as of June 30, 2025 and December 31, 2024.

The transaction was closed on August 29, 2025.

Accordingly, the operating results related to FibroGen International are classified as discontinued operations, and have been reflected as discontinued operations in the condensed consolidated statements of operations.

See Note 2, Discontinued Operations , for details.

See Note 2, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details.

LIQUIDITY AND CAPITAL RESOURCES

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We have historically funded our operations principally from the sale of common stock (including our public offering proceeds), from the execution of collaboration agreements involving license payments, milestone payments, reimbursement for development services, and the associated product revenue and drug product revenue.

Upon the close of the sales of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we received $210.4 million in cash paid at closing, and a total of $10.0 million cash payable by AstraZeneca at the closing subject to holdbacks of:

(i) a $6.0 million holdback to offset final net cash adjustments which will be released following a customary adjustment process approximately 90 days post-closing (as such time may be extended for the parties to mutually agree upon final adjustments), and (ii) a $4.0 million holdback to satisfy any indemnity claims, which will be released, net of any claims paid or unresolved, nine months after the closing.

On November 6, 2025, we received a $6.4 million payment from AstraZeneca, which is in full satisfaction of the first holdback of $6.0 million, plus $0.4 million that was an additional payment following the final net cash adjustments after closing.

See Note 2, Discontinued Operations and Divestiture , to the condensed consolidated financial statements for details.

In April 2023, we entered into the Financing Agreement with investment funds managed by MSTV, (“Lenders”), and Wilmington Trust, National Association, as the administrative agent, providing for senior secured term loan facilities consisting of a $75.0 million initial term loan.

The clinical development milestones which could have triggered Delayed Draw Term Loan 1 were not achieved, and the Lenders have not funded Delayed Draw Term Loan 2.

Upon the closing of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited on August 29, 2025, we repaid our term loan facility with the Lenders.

For additional details about this financing transaction, see Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements.

In November 2022, we entered into a Revenue Interest Financing Agreement (“RIFA”) with NovaQuest Capital Management (“NovaQuest”) with respect to our revenues from Astellas’ sales of roxadustat in Europe, Japan and the other Astellas territories.

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For additional details about this financing transaction, see Note 8, Liability Related to Sale of Future Revenues , to the condensed consolidated financial statements.

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 7, Senior Secured Revolving Line of Credit , to the condensed consolidated financial statements.

Upon the closing of the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited, we intend to repay our term loan facility with the Lenders.

In February 2025, we entered into an Equity Distribution Agreement with BofA Securities, Inc.

pursuant to which we may issue and sell, from time to time and through BofA Securities, Inc., shares of our common stock having an aggregate offering price of up to $30.0 million.

We did not sell any shares of common stock under this agreement during the three and six months ended June 30, 2025.

As of June 30, 2025, we had cash and cash equivalents of $23.4 million for our continuing operations, compared to $50.5 million as of December 31, 2024.

Cash is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.

In addition, as of June 30, 2025, we had $96.5 million of cash and cash equivalents and $22.1 million of accounts receivable in China, which were included in the held for sale assets on the condensed consolidated balance sheet.

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.

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.

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 II, Item 1A “ Risk Factors ” in this Quarterly Report.

We did not sell any shares of common stock under this agreement during the three and nine months ended September 30, 2025.

Cash and cash equivalents, investments and accounts receivable totaled $121.1 million at September 30, 2025.

Upon the close of our sale of FibroGen International to AstraZeneca during the third quarter of 2025, we accessed the entirety of our cash and cash equivalents held in China.

Cash Sources and Uses

The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods set forth below (in thousands), including both continuing operations and discontinued operations:

Six Months Ended June 30,

Nine Months Ended September 30,

Net cash provided by (used in):

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Operating Activities

Net cash provided by operating activities was $15.4 million for the six months ended June 30, 2025 and consisted primarily of net loss of $3.0 million adjusted for non-operating cash items of $6.2 million, and a net increase in operating assets and liabilities of $12.1 million.

The significant non-operating cash items included stock-based compensation expense of $4.7 million.

Net cash provided by operating activities was $13.6 million for the nine months ended September 30, 2025 and consisted primarily of net income of $197.7 million adjusted for non-operating cash items of $35.9 million, and a net decrease in operating assets and liabilities of $148.2 million.

The significant non-operating cash items included gain on divesture of FibroGen International of $52.2 million, loss on debt extinguishments of $6.6 million and stock-based compensation expense of $5.4 million.

The significant items in the changes in operating assets and liabilities included the following:

• Deferred revenue decreased $136.3 million, due to the recognition of all the previously deferred balance related to our China performance obligation under our agreements with AstraZeneca during the three months ended September 30, 2025 upon the completion of the divestiture of FibroGen International on August 29, 2025, as the performance obligation to AstraZeneca were completely satisfied upon the closing of the divestiture.

See the China Performance Obligation section in Note 3, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details;

• Accrued and other liabilities decreased $48.1 million, primarily driven by the $28.5 million distribution of litigation settlement related to our agreement in principle with plaintiffs to settle the class action lawsuit, $7.8 million of the transaction costs related to the divestiture, and the $3.2 million payments of accrued restructuring charge.

The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment;

• Accounts payable decreased $26.3 million, primarily driven by the payments made during the current year period to AstraZeneca under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items;

• Prepaid expenses and other current assets decreased $54.8 million, primarily due to the $28.5 million distribution of the above-mentioned litigation settlement during the quarter, which is fully recoverable under our insurance policies.

The decrease in prepaid expenses and other current assets was also related to the collection from Falikang during the quarter based on the arrangements under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, which was unbilled receivables as of December 31, 2024;

• Deferred revenue increased $7.5 million, primarily related to the $10.0 million additional deferred revenue during the quarter due to changes in estimate associated with the China performance obligation;

offset by the $2.0 million royalty revenue recognized from the deferred revenue under the Astellas Europe Agreement during the period.

See the Drug Product Revenue, Net section in Note 3, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details;

• Inventory decreased $4.2 million primarily driven by lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China in late 2024.

Inventory in China is part of the held-for-sale assets resulting from the Share Purchase Agreement with AstraZeneca Treasury Limited as discussed above and in Note 2, Discontinued Operations, to the condensed consolidated financial statements;

The decrease in prepaid expenses and other current assets was also related to the collection from Falikang during the current year period based on the arrangements under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items, which was unbilled receivables as of December 31, 2024;

• Accrued interest expense related to sale of future revenues increased $5.7 million due to the interest expense of $6.1 million accrued, offset by the interest paid of $0.5 million during the period.

See Note 8, Liability Related to Sale of Future Revenues , to the condensed consolidated financial statements for details;

• Accrued and other liabilities decreased $30.7 million, primarily driven by the $28.5 million distribution of litigation settlement related to our agreement in principle with plaintiffs to settle the class action lawsuit.

The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment;

• Accounts payable decreased $21.7 million, primarily driven by the payments made during the quarter to AstraZeneca under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items;

• Accounts receivable increased $3.0 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.

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 2, Discontinued Operations to the condensed consolidated financial statements.

Net cash used in operating activities was $99.2 million for the six months ended June 30, 2024 and consisted primarily of net loss of $48.5 million adjusted for non-operating cash items of $15.8 million, and a net decrease in operating assets and liabilities of $66.5 million.

• Inventory decreased $5.2 million primarily driven by lower inventory production in China as we have decommissioned our API manufacturing facility in Cangzhou, China in late 2024.

Inventory in China was part of the held-for-sale assets as of December 31, 2024 as discussed in Note 2, Discontinued Operations and Divestiture, to the condensed consolidated financial statements.

Net cash used in operating activities was $107.5 million for the nine months ended September 30, 2024 and consisted primarily of net loss of $65.6 million adjusted for non-operating cash items of $27.7 million, and a net decrease in operating assets and liabilities of $69.7 million.

The significant non-operating cash items included stock-based compensation expense of $25.0 million.

The significant items in the changes in operating assets and liabilities included the following:

• Accrued and other liabilities decreased $52.7 million, primarily 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 $19.1 million, offset by accrued inventory related cost of $8.5 million as of June 30, 2024, as part of the cost of goods sold resulting from the above-mentioned termination of the AstraZeneca U.S./RoW agreement.

The accrued and other liabilities were also impacted by the timing of invoicing and payment;

• Deferred revenue decreased $29.5 million, primarily related to the $20.6 million product revenue recognized from the previously deferred revenue of the China performance obligation during the six months ended June 30, 2023.

In addition, the decrease in deferred revenue was also related to the $2.1 million royalty revenue recognized from the deferred revenue under the Astellas Europe Agreement, and the reclassification of $5.4 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 six months ended June 30, 2023;

• Accounts payable decreased $8.0 million, primarily driven by the timing of invoicing and payments;

• Accrued interest expense related to sale of future revenues decreased $1.9 million due to the $5.7 million interest paid, offset by the interest expense of $3.7 million accrued during the six months ended June 30, 2024;

• Operating lease right-of-use assets decreased $66.0 million, operating lease liabilities, non-current decreased $65.8 million and operating lease liabilities, current decreased $12.8 million related to the operating lease termination of our corporate headquarters;

• Prepaid expenses and other current assets increased $18.2 million, primarily due to the $24.8 million of unbilled receivables from Falikang based on the arrangements under the settlement agreements entered in September 2024 between FibroGen China and AstraZeneca to settle certain historical items, and the reimbursements from the insurance for the legal fees associated with the class action lawsuit, which is recoverable under our insurance policies;

• Accrued and other liabilities decreased $17.1 million, primarily 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 and bonus and severance payouts, totaling $25.2 million.

The decreases were offset by $42.4 million of historical co-promotion balances due to AstraZeneca based on the arrangements under the above-mentioned settlement agreements, accrued restructuring charge of $18.6 million related to the reduction in force in August 2024, and accrued inventory related cost of $8.5 million as of September 30, 2024, as part of the cost of goods sold resulting from the above-mentioned termination of the AstraZeneca U.S./RoW agreement.

The accrued and other liabilities were also impacted by cost control efforts and the timing of invoicing and payment;

• Accounts receivable increased $16.0 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;

• Deferred revenue decreased $15.2 million, primarily related to the $33.1 million product revenue recognized from the previously deferred revenue of the China performance obligation during the nine months ended September 30, 2023.

In addition, the decrease in deferred revenue was also related to the $3.2 million royalty revenue recognized from the deferred revenue under the Astellas Europe Agreement, and the reclassification of $5.6 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 nine months ended September 30, 2023.

Deferred revenue was no longer netted against any contract assets as of September 30, 2024, and 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 three months ended September 30, 2024 under the above-mentioned settlement agreements;

• Accounts payable decreased $8.7 million, primarily driven by the timing of invoicing and payments and cost control efforts;

• Inventory decreased $17.8 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.

• Accounts receivable decreased $6.0 million, primarily driven by the receipt of the billings under our collaboration and license agreements;

• Prepaid expenses and other current assets decreased $4.5 million, primarily due to the reimbursements from the insurance for the legal fees associated with the class action lawsuit, which is recoverable under our insurance policies.

Investing Activities

Investing activities primarily consist of purchases of property and equipment, purchases of investments and proceeds from the maturity and sale of investments.

Net cash used in investing activities was immaterial for the six months ended June 30, 2025.

Net cash provided by investing activities was $123.5 million for the six months ended June 30, 2024 and consisted primarily of $132.2 million of proceeds from maturities of investments, partially offset by $8.6 million of cash used in purchases of available-for-sale securities.

Investing activities primarily consist of net proceeds from divestiture, purchases of investments and proceeds from the maturity and sale of investments.

Net cash provided by investing activities was $87.1 million for the nine months ended September 30, 2025 and consisted primarily of $90.2 million net proceeds from the divestiture of FibroGen International on August 29, 2025, which included the $210.4 million of cash received at closing, net of the $120.2 million cash in China at the closing that were derecognized upon the divestiture;

partially offset by $3.0 million cash used in purchases of available-for-sale securities.

Net cash provided by investing activities was $124.3 million for the nine months ended September 30, 2024 and consisted primarily of $132.2 million of proceeds from maturities of investments, partially offset by $8.6 million of cash used in purchases of available-for-sale securities.

Financing Activities

Financing activities primarily reflect proceeds from strategic financing arrangements, proceeds from the issuance of our common stock, cash paid for payroll taxes on restricted stock unit releases, and repayments of our lease liabilities and obligations.

Net cash used in financing activities was immaterial for the six months ended June 30, 2025 and 2024.

Financing activities primarily reflect proceeds from strategic financing arrangements, proceeds from the issuance of our common stock, cash paid related to our senior secured term loan facilities, cash paid to shareholders and cash paid for payroll taxes on restricted stock unit releases.

Net cash used in financing activities was $86.0 million for the nine months ended September 30, 2025 and consisted primarily of $75.0 million of cash used to pay off our senior secured term loan facilities with MSTV and $5.5 million of cash paid for the related premium and fees associated with the early pay-off.

See Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements for details.

Net cash used in financing activities also included $5.4 million of cash paid to FibroGen Cayman’s minority shareholders during the third quarter of 2025.

See Note 9, FibroGen Cayman Non-Controlling Interests, to the condensed consolidated financial statements for details.

Net cash used in financing activities was immaterial for the nine months ended September 30, 2024.

Material Cash Requirements

We generate revenue from commercial sales of roxadustat product in China, Japan and Europe.

Even with the expectation of increases in these revenues and the sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited, we anticipate that we will continue to generate losses for the foreseeable future.

We generate revenue from commercial sales of roxadustat product in Japan and Europe.

Even with these revenues, we anticipate that we will continue to generate losses for the foreseeable future.

To date, we have funded certain portions of our research and development and manufacturing efforts globally through collaboration partners, debt financings, and equity financing.

We expect to continue to incur significant research and development expenses to invest in our other programs and there is no guarantee that sufficient funds will be available to continue to fund these development efforts through commercialization or otherwise.

We expect to continue to incur significant research and development expenses to invest in our development programs and there is no guarantee that sufficient funds will be available to continue to fund these development efforts through commercialization or otherwise.

We are also subject to all the risks related to the development and commercialization of novel therapeutics, and we may encounter unforeseen expenses, difficulties, complications, delays and other factors outlined under Part II, Item 1A “ Risk Factors ” in this Quarterly Report on Form 10-Q, as well as unknown factors that may adversely affect our business.

We anticipate that we will need substantial additional funding in connection with our continuing operations.

If we are unable to complete the above mentioned sale of FibroGen International and its subsidiaries to AstraZeneca Treasury Limited, access additional cash from our China operations, or raise additional capital in the U.S., we would not have sufficient liquidity to continue operations in the U.S.

for the 12 months from the date that the financial statements are issued and would not be able to comply with its financial covenant that requires a minimum balance of $18.75 million of unrestricted cash and cash equivalents to be held in accounts in the U.S.

Upon an event of default, our senior secured term loan facilities could become immediately due and payable.

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.

There is also the potential that we raise additional funds in the U.S.

at any time through equity, equity-linked, or debt financing arrangements or from other sources.

There can be no assurances that these plans will be successful.

As a result of these factors, 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.

Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth under Part II, Item 1A “ Risk Factors ” in this Quarterly Report on Form 10-Q.

We may not be able to secure additional financing to meet our operating requirements on acceptable terms, or at all.

If we raise additional funds by issuing equity or equity-linked securities, the ownership of our existing stockholders will be diluted.

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.

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

Contractual Obligations

As of June 30, 2025, we had outstanding total non-cancelable purchase obligations of $3.1 million for general purchases and other programs and $0.5 million for manufacture and supply of roxadustat, all of which are expected to be paid within the next 12 months.

As of September 30, 2025, we had outstanding total non-cancelable purchase obligations of $4.0 million for general purchases and other programs and $2.6 million for manufacture and supply of roxadustat, all of which are expected to be paid within the next 12 months.

We expect to fulfill our commitments under these agreements in the normal course of business, and as such, no liability has been recorded.

Under the Financing Agreement with Morgan Stanley Tactical Value, as of June 30, 2025, we had $73.7 million of senior secured term loan facilities balance on the condensed consolidated balance sheets, which is subject for repayment within the next 12 months.

In addition, we are obliged to pay interest on a monthly basis, for which we expect to pay a total of $9.0 million within the next 12 months.

See Note 7, Senior Secured Term Loan Facilities , to the condensed consolidated financial statements for details.

Under the RIFA with NovaQuest, as of June 30, 2025, we had $63.0 million of liability related to sale of future revenues in the condensed consolidated balance sheets, $1.7 million of which we anticipate to pay within the next 12 month.

Under the RIFA with NovaQuest, as of September 30, 2025, we had $65.0 million of liability related to sale of future revenues in the condensed consolidated balance sheets, $1.6 million of which we anticipate to pay within the next 12 month.

Based on our current estimates of drug product revenue and revenue from milestone payments under the Astellas Agreements, and taking into the consideration of the terms under the RIFA, we anticipate to reach a Payment Cap up to $125.0 million by 2031.

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Actual results may differ from these estimates under different assumptions or conditions.

There have been no material changes in our critical accounting policies, estimates and judgments during the three and six months ended June 30, 2025 compared with the disclosures in Part II, Item 7 of our 2024 Form 10-K.

There have been no material changes in our critical accounting policies, estimates and judgments during the three and nine months ended September 30, 2025 compared with the disclosures in Part II, Item 7 of our 2024 Form 10-K.

QUANTITATIVE AND QUALITAT IVE DISCLOSURES ABOUT MARKET RISK.

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What changed 10-Q

Item 2. Management’s Discussion and Analysis