What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-11 compared with 2025-05-12 · 138 added, 128 removed, 329 unchanged (45% of the section changed)

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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 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.

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(“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 (China) Medical Technology Development Co., Ltd and its 51.1% interest in Beijing Falikang Pharmaceutical Co.

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.

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 United States, Canada, or Mexico.

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

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

one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.

We continue to evaluate a development plan for roxadustat in anemia associated with lower-risk MDS, a high-value indication with significant unmet medical need.

We filed our Type-C meeting request with the U.S.

Food and Drug Administration (“FDA”) in the second quarter of 2025 and expect feedback on the potential path forward for roxadustat in anemia associated with lower risk MDS in the third quarter of 2025.

We continue to work on our development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need.

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

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

Financial Highlights

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(in thousands, except for per share data)

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Loss from continuing operations per share - basic and diluted

March 31, 2025

June 30, 2025

December 31, 2024

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Accounts receivable

Our revenue for the three months ended March 31, 2025 included primarily the drug product revenue of $2.6 million related to active pharmaceutical ingredient (“API”) deliveries to Astellas Pharma Inc.

(“Astellas”).

As a comparison, our revenue for the three months ended March 31, 2024 included primarily the revenue recognized related to the following, respectively:

• $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.

• $1.2 million of net reduction to drug product revenue related to API deliveries to Astellas;

• $0.8 million of development revenue recognized under our collaboration agreements with our partners Astellas and AstraZeneca.

Operating costs and expenses for the three months ended March 31, 2025 decreased compared to the same period a year ago primarily as a result of the net effect of the following:

• $21.1 million one-time cost of goods sold recorded for the three months ended March 31, 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;

• $11.5 million lower employee-related expenses primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• $6.9 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;

• $6.5 million lower facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;

• $5.8 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;

• $2.4 million lower drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated.

For the three months ended March 31, 2025, we had a loss from continuing operations of $16.8 million, or a loss per basic and diluted share of $0.16, as compared to a loss of $49.0 million, or a loss per basic and diluted share of $0.49, 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 $33.8 million at March 31, 2025, a decrease of $17.2 million from December 31, 2024.

Consolidated cash and cash equivalents and accounts receivable for both continuing operations and discontinued operations totaled $128.4 million at March 31, 2025, an increase of $7.3 million from December 31, 2024, primarily due to the cash provided by operations as discussed under the Liquidity and Capital Resources section below.

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;

• $0.3 million and $1.1 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;

• $7.2 million and $14.6 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;

• $3.6 million and $10.5 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;

• $2.6 million and $5.0 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.

Commercial, Development and Research Programs

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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 (“mHSPC”) receive chemotherapy in first-line mCRPC.

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.

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

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.

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In addition to CD46 being expressed at high levels in certain tumor types with limited expression in most normal tissues, CD46 is a cell receptor that induces internalization upon antibody binding, which makes it an ideal target for an ADC.

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

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.

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

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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 androgen receptor signaling inhibitors, which included prior enzalutamide treatment.

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

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

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

The Company continues to evaluate a development plan for Roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical needs.

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.

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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is estimated to be between 60,000 and 170,000, and continues to rise as more therapies become available and patients are living longer with MDS.

Annual incidence rates are estimated to be 4.9/100,000 adults in the U.S., and 1.51/100,000 adults in China.

Annual incidence rates are estimated to be 4.9/100,000 adults in the U.S.

Anemia is the most common clinical presentation in MDS, seen in approximately 80% of MDS patients, and produces symptoms of fatigue, weakness, exercise intolerance, shortness of breath, dizziness, and cognitive impairment.

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Lower-risk MDS patients represent approximately 77% of the total diagnosed MDS population.

National Comprehensive Cancer Network (“NCCN”) guidelines recommend the use of erythropoiesis-stimulating agents (“ESAs”), luspatercept and imetelstat in lower risk MDS patients, depending on patients’ treatment history, serum erythropoietin (“EPO”) levels and ring sideroblast status .

National Comprehensive Cancer Network guidelines recommend the use of ESAs, luspatercept and imetelstat in lower risk MDS patients, depending on patients’ treatment history, serum erythropoietin (“EPO”) levels and ring sideroblast status .

Currently available treatment options are effective in only ~50% patients and they are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion.

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Unlike ESAs which are limited to providing exogenous EPO, roxadustat activates a coordinated erythropoietic response in the body that includes the stimulation of red blood cell progenitors, an increase in the body’s production of endogenous EPO, and an increase in iron availability for hemoglobin synthesis, which we believe is important in a broad range of MDS patients.

Moreover, in anemia of chronic kidney disease (“CKD”), roxadustat has demonstrated the ability in clinical trials to increase and maintain hemoglobin levels in the presence of inflammation as measured by C-reactive protein (“CRP”), where ESAs have shown limited effect.

Moreover, in anemia of CKD, roxadustat has demonstrated the ability in clinical trials to increase and maintain hemoglobin levels in the presence of inflammation as measured by C-reactive protein (“CRP”), where ESAs have shown limited effect.

We believe that roxadustat has the potential to replicate this result in MDS anemia patients, where it is not uncommon for patients to present with autoimmune and inflammatory conditions.

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however, the p-value was not significant.

However, in a post-hoc analysis of patients with higher transfusion burden (2 or more units of packed red blood cells every 4 weeks), 36.1% of the 36 roxadustat patients achieved transfusion independence, versus 11.5% of the 26 patients in the placebo arm (p=0.047).

We filed our Type-C meeting request with the FDA in the second quarter of 2025 and expect feedback on the potential path forward for roxadustat in anemia associated with lower-risk MDS in the third quarter of 2025.

However, in a post-hoc analysis of patients with high transfusion burden (4 or more packed RBC units over two consecutive 8-week periods), 36% of the 22 roxadustat patients achieved transfusion independence, versus 7% of the 15 placebo patients (nominal p-value of 0.04).

Roxadustat in Anemia of Chronic Kidney Disease

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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 approximately $185 million, 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, currently anticipated to be approximately $100 million, as of the closing.

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.

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.

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one for Japan, and one for Europe, the Commonwealth of Independent States, the Middle East and South Africa.

Preclinical Portfolio

Our preclinical portfolio consists of two antibodies for immuno-oncology that are in investigational new drug application-enabling studies.

FG-3165 is a galectin-9 (“Gal9”) targeted antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression.

Gal9 has been reported to bind to multiple immune checkpoints on lymphocytes that suppress T and natural killer cell activation, and it is a driver of cancer progression in acute myeloid leukemia.

In preclinical studies FG-3165 and its variants inhibit Gal9 mediated T cell death, and also promotes anti-tumor immune responses in combination with other immune checkpoint targeted drugs.

In June 2024, we received FDA clearance for our investigational new drug application for FG-3165.

FG-3175 is a c-c motif chemokine receptor 8 (“CCR8”) targeted antibody under development for treatment of solid tumors that are highly infiltrated by CCR8-positive T regulatory cells.

T regulatory cells contribute to an immune suppressed tumor microenvironment, and multiple preclinical studies have demonstrated immune activation and tumor regression following depletion of this cell type from the tumor microenvironment.

FG-3175 is a variant of our previous lead anti-CCR8 antibody, FG-3163, and was deemed to be a superior clinical candidate following extended characterization of both antibodies.

FG-3175 has enhanced antibody dependent cellular cytotoxicity activity and induces potent killing of CCR8 expressing cells by natural killer cells in in vitro assay systems.

Exclusive License from and Option to Acquire Fortis Therapeutics

In May 2023, we entered into an exclusive option agreement to acquire Fortis with its novel Phase 1 antibody-drug conjugate, FG-3246 (previously FOR46), that targets a novel epitope on CD46 preferentially expressed on certain cancer cells.

In May 2023, we entered into an exclusive option agreement to acquire Fortis with its novel Phase 1 ADC, FG-3246 (previously FOR46), that targets a novel epitope on CD46 preferentially expressed on certain cancer cells.

FG-3246 is in development for the treatment of mCRPC with potential applicability in other solid tumors and hematologic malignancies.

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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.

In addition to the upfront payments we previously paid, HiFiBiO may receive up to a total of $345 million in future clinical, regulatory, and commercial milestone payments for each program.

HiFiBiO will also be eligible to receive tiered royalties based upon worldwide net sales.

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

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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 March 31, 2025 totaled $790.1 million.

Under these agreements, the aggregate amount of consideration received through June 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 $1.8 million and $(2.2) million for the three months ended March 31, 2025 and 2024, respectively.

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.

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 $0.8 million and $1.0 million for the three months ended March 31, 2025 and 2024, respectively.

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.

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 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 March 31, 2025 totaled $81.2 million.

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 (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 .

(“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 .

AstraZeneca China Amendment

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We account for our investment in Falikang under the equity method, and Falikang is not consolidated into our consolidated financial statements.

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 in the condensed consolidated balance sheet.

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

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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 $39.8 million and $30.5 million for the three months ended March 31, 2025 and 2024, respectively, majority of which were from the sales to Falikang.

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.

RESULTS OF OPERATIONS

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 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 March 31, 2025, we do not expect to incur significant future co-development services.

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.

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

Total revenue decreased $22.6 million, or 89%, for the three months ended March 31, 2025, compared to the same period a year ago for the reasons discussed in the sections below.

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.

Drug Product Revenue, Net

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

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NM = Not meaningful

Drug product revenue, net decreased $21.9 million, or 89%, for the three months ended March 31, 2025, compared to the same period a year ago.

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.

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 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 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.

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

During the first 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 $2.2 million.

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

As of March 31, 2025, the balances related to the API price true-up under the Astellas Japan Agreement were $0.7 million in accrued liabilities and $0.6 million in other long-term liabilities, representing our best estimate of the timing for these amounts to be paid.

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.

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 $2.1 million from the related deferred revenue to accrued liabilities during the three months ended March 31, 2025.

As of March 31, 2025, the balances related to the bulk drug product price true-up under the Astellas Europe Agreement and the Astellas EU Supply Agreement were $12.6 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 $0.8 million and $1.0 million for the three months ended March 31, 2025 and 2024, respectively.

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.

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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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.

Accordingly, during the three months ended March 31, 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.

Accordingly, during the first quarter of 2024, we accounted for the termination of the AstraZeneca U.S./RoW agreement as a contract modification under the ASC 606 and recorded a cumulative catch-up net adjustment of $25.7 million to the drug product revenue.

Operating Costs and Expenses

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

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Total operating costs and expenses

Total operating costs and expenses decreased $56.9 million, or 76%, compared to the same period a year ago for the reasons discussed in the sections below.

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.

Cost of Goods Sold

Cost of goods sold decreased $21.1 million, or 99%, for the three months ended March 31, 2025, compared to the same period a year ago.

As described above, during the three months ended March 31, 2024, we recorded a cumulative catch-up net adjustment to the drug product revenue resulting from the AstraZeneca Termination and Transition Agreement related to the AstraZeneca U.S./RoW Agreement.

Correspondingly, we recorded the related cost of goods sold of $21.1 million during the three months ended March 31, 2024.

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.

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.

Correspondingly, we recorded the related cost of goods sold of $21.1 million in the same period.

Research and Development Expenses

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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 months ended March 31, 2025 and 2024:

Three Months Ended March 31,

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,

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 $27.3 million, or 75%, for the three months ended March 31, 2025, compared to the same period a year ago, primarily as a result of the net effect of the following:

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

• Decrease of $6.9 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 $5.8 million in facilities-related expenses due to cost control efforts including the lease termination in the third quarter of 2024;

• Decrease of $3.3 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 $2.4 million in drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated.

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;

• Decrease of $6.1 million and $11.9 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 $2.6 million and $5.0 million in drug development expenses associated with drug substance activities and logistic expenses related to pamrevlumab programs which were completed and terminated.

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 $8.6 million, or 52%, for the three months ended March 31, 2025, compared to the same period a year ago, primarily as a result of the net effect of the following, respectively:

• Decrease of $3.6 million in employee-related costs primarily due to the impact from reduction in force action in August 2024 and cost control efforts;

• Decrease of $2.5 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.

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;

• Decrease of $3.3 million and $5.8 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.

Restructuring Charge

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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 months ended March 31, 2025 was not material.

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

Interest and Other, Net

Three Months Ended March 31,

Three Months Ended June 30,

Six Months Ended June 30,

(dollars in thousands)

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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 months ended March 31, 2025.

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

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 $1.8 million, or 82%, compared to the same period a year ago, primarily due to lower interest income resulting from lower cash equivalents and investment balances.

Three Months Ended March 31,

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,

(dollars in thousands)

Loss from continuing operations before income taxes

Provision for income taxes

Benefit from income taxes

Effective tax rate

Provisions for income taxes for the three months ended March 31, 2025 and 2024 were primarily due to foreign taxes.

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

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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 and its 51.1% interest in Falikang.

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 March 31, 2025 and December 31, 2024.

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

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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 months ended March 31, 2025.

As of March 31, 2025, we had cash and cash equivalents of $33.6 million for our continuing operations, compared to $50.5 million as of December 31, 2024.

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 March 31, 2025, we had $72.6 million of cash and cash equivalents and $22.0 million of accounts receivable in China, which were included in the held for sale assets in the condensed consolidated balance sheet.

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.

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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:

Three Months Ended March 31,

Six Months Ended June 30,

Net cash provided by (used in):

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Effect of exchange rate changes on cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Net increase in cash and cash equivalents

Operating Activities

Net cash provided by operating activities was $2.7 million for the three months ended March 31, 2025 and consisted primarily of net income of $4.6 million adjusted for non-operating cash items of $3.7 million, and a net decrease in operating assets and liabilities of $5.7 million.

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.

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

• Accrued and other liabilities decreased $31.7 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, and bonus and severance payouts totaling $5.1 million during the quarter.

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

• Accounts payable decreased $24.8 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;

• Deferred revenue decreased $4.1 million, primarily related to the reclassification of $2.1 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 3, Collaboration Agreements, License Agreement and Revenues , to the condensed consolidated financial statements for details.

In addition, the decrease in deferred revenue was also related to the $1.3 million product revenue recognized, which is included in the discontinued operations, from the previously deferred revenue of the China performance obligation during the quarter;

• Accounts receivable increased $3.2 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;

• Prepaid expenses and other current assets decreased $51.5 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;

• Accrued interest expense related to sale of future revenues increased $1.7 million due to the interest expense of $2.2 million accrued, offset by the interest paid, during the quarter.

• Accrued interest expense related to sale of future revenues increased $3.7 million due to the interest expense of $4.1 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;

Net cash used in operating activities was $59.3 million for the three months ended March 31, 2024 and consisted primarily of net loss of $32.9 million adjusted for non-operating cash items of $7.7 million, and a net decrease in operating assets and liabilities of $34.1 million.

• 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.

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.

The significant non-operating cash items included stock-based compensation expense of $17.4 million.

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

• Accounts receivable increased $24.7 million, primarily driven by the receivable from AstraZeneca of $26.0 million associated with the settlement of the past transactions under the above-mentioned settlement agreements between FibroGen China and AstraZeneca to settle certain historical items;

• Accounts payable decreased $13.6 million, primarily driven by the timing of invoicing and payments;

• Deferred revenue decreased $10.2 million, primarily related to the reclassification of $5.7 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 three months ended March 31, 2024.

In addition, the decrease in deferred revenue was also related to the product revenue recognized from the previously deferred revenue of the China performance obligation during the three months ended March 31, 2024;

• Accrued interest expense related to sale of future revenues decreased $3.6 million due to the $5.7 million interest paid, offset by the interest expense of $2.0 million accrued during the three months ended March 31, 2024;

• Accrued and other liabilities decreased $3.0 million, primarily related to bonus and severance payouts totaling $19.1 million, offset by accrued inventory related cost of $8.5 million as of March 31, 2024, as part of the cost of goods sold resulting from the above-mentioned termination of the AstraZeneca U.S./RoW agreement, as well as the movements related to API and bulk drug product price true-up, resulting from changes in estimated variable consideration primarily associated with the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement.

• 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;

• Inventory decreased $15.6 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.

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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 three months ended March 31, 2025.

Net cash provided by investing activities was $51.3 million for the three months ended March 31, 2024 and consisted primarily of $59.9 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 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.

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 three months ended March 31, 2025 and 2024.

Net cash used in financing activities was immaterial for the six months ended June 30, 2025 and 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, we anticipate that we will continue to generate losses for the foreseeable future.

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.

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.

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.

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 $27 million of unrestricted cash and cash equivalents to be held in accounts in the United States.

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.

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Contractual Obligations

As of March 31, 2025, we had outstanding total non-cancelable purchase obligations of $2.3 million for general purchases and other programs, $0.7 million for manufacture and supply of roxadustat, and $0.3 million for Manufacture and supply of FG-3246, all of which are expected to be paid within the next 12 months.

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.

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 March 31, 2025, we had $73.4 million of senior secured term loan facilities balance on the condensed consolidated balance sheets, which are not subject for repayment until May 2026.

Meanwhile, we are obliged to pay interest on a monthly basis, for which we expect to pay a total of $10.5 million within the next 12 months.

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 March 31, 2025, we had $61.0 million of liability related to sale of future revenues on the condensed consolidated balance sheets, $1.9 million of which we anticipate to pay within the next 12 month.

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.

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 months ended March 31, 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 six months ended June 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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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.

What changed 10-Q

Item 2. Management’s Discussion and Analysis