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Akebia Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 5, 2026

AKBA$0.40-5.7%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0001517022-26-000051

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-05.

0001517022-26-000084

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 181 previous paragraphs and 177 current paragraphs.

120 unchanged; 51 reworded; 5 added; 7 removed; 3 previous and 1 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

Initiation of Phase 2 Trial in Rare Complement-Mediated Kidney Diseases

Current report

In September 2026, we dosed our first patient in a Phase 2 basket trial evaluating ebribafusp for the treatment of rare complement-mediated kidney diseases, including IgAN, LN and C3G. As a result, pursuant to the terms of the Q32 Purchase Agreement, we paid $1.9 million of the $2.0 million development milestone in September 2026 upon such dosing and paid the remaining $0.1 million in October 2026.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025

Current report

Income Tax Expense—Income tax expense was $0.4 million and $0.6 million for the nine months ended September 30, 2026 and 2025, respectively.
Removed paragraphs (7)

Previous report

Product Revenue, Net—Net product revenue is derived from sales of Auryxia and Vafseo in the U.S. We distribute Auryxia and Vafseo principally through a limited number of dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our AG Distributor for Auryxia.

Previous report

Product Revenue, Net—Net product revenue is derived from sales of Auryxia and Vafseo in the U.S. We distribute Auryxia and Vafseo principally through a limited number of dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our AG Distributor for Auryxia.

Previous report

Income Tax Expense—Income tax expense was $0.2 million for the six months ended June 30, 2026. There was no income tax expense for the six months ended June 30, 2025.
Reworded paragraphs (51)

Previous wording

Today, we market Auryxia in the U.S. Auryxia became part of our portfolio in 2018 and has historically contributed meaningful revenue to the business. In March 2025, Auryxia reached loss of exclusivity, or LoE. On March 11, 2026, Teva Pharmaceuticals Ltd., or Teva, received approval for its Abbreviated New Drug Application, or ANDA, for a generic version of Auryxia, which has subsequently entered the market.

Current wording

Today, we market Auryxia in the U.S. Auryxia became part of our portfolio in 2018 and has historically contributed meaningful revenue to the business. In March 2025, Auryxia reached loss of exclusivity, or LoE. On March 11, 2026, Teva Pharmaceuticals USA, Inc., or Teva, received approval for its Abbreviated New Drug Application, or ANDA, for a generic version of Auryxia, which has subsequently entered the market.

Previous wording

Our mid-stage rare kidney disease pipeline assets, praliciguat and ebribafusp, are being evaluated to target areas of unmet need. In June 2021, we licensed praliciguat from Cyclerion Therapeutics, Inc., or Cyclerion, via an exclusive global license, which includes certain intellectual property rights to research, develop and commercialize the asset. Praliciguat is an oral, once-daily soluble guanylate cyclase, orsGC, stimulator. We are evaluating praliciguat for the treatment of biopsy-confirmed focal segmental glomerulosclerosis, or FSGS, a rare kidney disease, in a Phase 2 clinical trial. The first patient was dosed in this trial in December 2025. We also plan to assess the use of praliciguat in other rare podocytopathies in the future.

Current wording

Our mid-stage rare kidney disease pipeline assets, praliciguat and ebribafusp, are being evaluated to target areas of unmet need. In June 2021, we licensed praliciguat from Cyclerion Therapeutics Inc. (succeeded by Korsana Biosciences Inc.), or Cyclerion, via an exclusive global license, which includes certain intellectual property rights to research, develop and commercialize the asset. Praliciguat is an oral, once-daily soluble guanylate cyclase, orsGC, stimulator. We are evaluating praliciguat for the treatment of biopsy-confirmed focal segmental glomerulosclerosis, or FSGS, a rare kidney disease, in a Phase 2 clinical trial. We dosed our first patient in this trial in December 2025. We also plan to assess the use of praliciguat in other rare podocytopathies in the future.

Previous wording

In November 2025, we entered into an asset purchase agreement with Q32 Bio Inc. and Q32 Bio Operations Inc., together Q32, pursuant to which we purchased and assumed substantially all assets and liabilities of Q32 and its affiliates related to the research, development, manufacture and commercialization of Q32’s clinical-stage development candidate ADX-097, known as ebribafusp (AKB-097), an anti-C3d-Factor H fusion protein complement inhibitor. Ebribafusp is a potential next-generation complement inhibitor, and we believe ebribafusp has applicability across a wide range of complement-mediated rare kidney diseases. Ebribafusp is intended to provide targeted regulation of complement activation at sites of tissue injury while limiting systemic complement inhibition. In August

Current wording

In November 2025, we entered into an Asset Purchase Agreement, or the Q32 Purchase Agreement, with Q32 Bio Inc. and Q32 Bio Operations Inc., together Q32, pursuant to which we purchased and assumed substantially all assets and liabilities of Q32 and its affiliates related to the research, development, manufacture and commercialization of Q32’s clinical-stage development candidate ADX-097, known as ebribafusp (AKB-097), an anti-C3d-Factor H fusion protein complement inhibitor. Ebribafusp is a potential next-generation complement inhibitor, and we believe ebribafusp has applicability across a wide range of complement-mediated rare kidney diseases. Ebribafusp is intended to provide targeted regulation of complement activation at sites of tissue injury while limiting systemic complement inhibition. In September 2026, we dosed our first patient in a Phase 2 basket study to evaluate ebribafusp in IgA Nephropathy, or IgAN, C3 Glomerulopathy, or C3G, and Lupus Nephritis, or LN.

Previous wording

We expect to continue to generate revenue from our license, collaboration and supply agreements with MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, Tanabe Pharma Corporation, or TPC, Japan Tobacco, Inc., and its subsidiary, Torii Pharmaceutical Co., Ltd., collectively, JT and Torii, and any other collaborations into which we have entered or may enter.

Current wording

We expect to continue to generate revenue from our license, collaboration and supply agreements with MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, Tanabe Pharma Corporation, or TPC, Japan Tobacco, Inc. (succeeded by Shionogi & Co., Ltd.) and its subsidiary, Torii Pharmaceutical Co., Ltd., collectively, JT and Torii, and any other collaborations into which we have entered or may enter.

Previous wording

Change in fair value of warrant liability relates to the change in fair value of our warrant liability related to a warrant agreement with Kreos Capital VII Aggregator SCSp, an affiliate of Kreos Capital VII (UK) Limited, or Kreos. See Note 3, Fair

Current wording

Change in fair value of warrant liability relates to the change in fair value of our warrant liability related to a warrant agreement with Kreos Capital VII Aggregator SCSp, an affiliate of Kreos Capital VII (UK) Limited, or Kreos. See Note 3, Fair Value Measurements, and Note 7, Indebtedness, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the warrant liability.

Previous wording

On April 9, 2026, we extended the term of our lease for office and laboratory space in Cambridge, Massachusetts, or the Cambridge Lease, with respect to the laboratory space from September 11, 2026 to October 31, 2026. See Note 9, Leases, in the accompanying notes to the consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the Cambridge Lease.

Current wording

In April and September 2026, we entered into amendments to our lease for office and laboratory space in Cambridge, Massachusetts, or the Cambridge Lease, to extend the term of the laboratory space and office and storage space, respectively, from September 11, 2026 to October 31, 2026. See Note 9, Leases, in the accompanying notes to the consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the Cambridge Lease.

Previous wording

In January 2026, we entered into a lease agreement, or the Waltham Lease, pursuant to which we will lease an aggregate of approximately 43,474 square feet, consisting of 28,518 square feet of office space and 14,956 square feet of laboratory space located in Waltham, Massachusetts. We intend to relocate our corporate headquarters to Waltham in September 2026.

Current wording

In January 2026, we entered into a lease agreement, or the Waltham Lease, pursuant to which we lease an aggregate of 43,474 square feet, consisting of 28,518 square feet of office space and 14,956 square feet of laboratory space located in Waltham, Massachusetts. We relocated our corporate headquarters to Waltham in September 2026.

Previous wording

Net product revenue was $46.8 million for the three months ended June 30, 2026, compared to $60.5 million for the three months ended June 30, 2025. The decrease was primarily due to lower Auryxia revenues, which were partially offset by higher Vafseo revenues.

Current wording

Product Revenue, Net—Net product revenue was $34.8 million for the three months ended September 30, 2026, compared to $56.8 million for the three months ended September 30, 2025. The decrease was primarily due to lower Auryxia revenues. The lower Auryxia revenues are primarily driven by a decrease in net price as well as a decrease in sales volume of Auryxia due to generic competition.

Previous wording

Following LoE for Auryxia in March 2025, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S. On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia. As a result of Teva's entry into the market, we have experienced, and we expect to continue to experience, a significant reduction in the volume of Auryxia sales. We expect the ongoing sales of generic versions of Auryxia, including by Teva and our AG Distributor, and of any additional generic versions of Auryxia that may be approved, will continue to have a significant adverse impact on our revenue. However, the extent of the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations on favorable terms, or at all, the timing and number of additional generics, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

Current wording

Following LoE for Auryxia in March 2025, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S. On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia. As a result of Teva's entry into the market, we have experienced a significant reduction in the volume of Auryxia sales. We expect the ongoing sales of generic versions of Auryxia, including by Teva and our AG Distributor, and of any additional generic versions of Auryxia that may be approved, will continue to have a significant adverse impact on our revenue. However, the extent of the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations and other customers, including specialty distributors, on favorable terms, or at all, the timing and number of additional generics, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

Previous wording

As a result of changes in the amount of reimbursement dialysis facilities will receive for use of Vafseo when Vafseo transitions from the Transitional Drug Add-on Payment Adjustment, or TDAPA, period to the post-TDAPA period beginning in 2027, we expect to price Vafseo within the range of the price for ESAs. ESAs are currently priced significantly lower than Vafseo’s current price. As a result, while we expect to sell a higher unit volume of Vafseo in 2027 as compared to 2026, we expect Vafseo revenues to decrease significantly in 2027 as compared to 2026 due to the expected lower price point.

Current wording

As a result of changes in the amount of reimbursement dialysis facilities will receive for use of Vafseo when Vafseo transitions from the Transitional Drug Add-on Payment Adjustment, or TDAPA, period to the post-TDAPA period, we believe our customers are likely to reduce inventory levels at the end of 2026. Additionally, when the post-TDAPA period begins in 2027, we expect to price Vafseo within the range of the price for ESAs. ESAs are currently priced significantly lower than Vafseo’s current price. As a result, while we expect to sell a higher unit volume of Vafseo in 2027 as compared to 2026, we expect Vafseo revenues to decrease significantly in 2027 as compared to 2026 due to the expected lower price point.

Previous wording

License, Collaboration and Other Revenue—License, collaboration and other revenue was $3.9 million for the six months ended June 30, 2026, compared to $3.6 million for the six months ended June 30, 2025. The increase was primarily due to revenue recognized in connection with our supply agreement with Medice during the six months ended June 30, 2026.

Current wording

License, Collaboration and Other Revenue—License, collaboration and other revenue was $2.1 million for the three months ended September 30, 2026, compared to $2.0 million for the three months ended September 30, 2025.

Previous wording

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $22.7 million for the six months ended June 30, 2026 compared to $17.5 million for the six months ended June 30, 2025. The increase was primarily due to an increase in inventory write-downs as a result of excess, obsolescence, scrap or other reasons during the six months ended June 30, 2026.

Current wording

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $6.4 million for the three months ended September 30, 2026 compared to $9.4 million for the three months ended September 30, 2025. The decrease was primarily due to lower Auryxia sales volume during the three months ended September 30, 2026.

Previous wording

We began capitalizing our Vafseo costs in March 2024, in connection with the FDA's approval of Vafseo for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Prior to the capitalization of Vafseo inventory costs, such costs were recorded as research and development expenses in the period incurred. Cost of product and other revenue for Vafseo was $2.4 million for the six months ended June 30, 2026, comprised of manufacturing and overhead costs as the associated inventory costs such as raw materials, drug substance and drug product conversion costs were expensed previously. If Vafseo inventory sold during the six months ended June 30, 2026 was valued at cost, our cost of product and other revenue would have been $9.7 million. As of June 30, 2026, we had $18.2 million of reduced-cost Vafseo inventory. We expect our cost of product and other revenue for Vafseo will increase, reflecting the full cost of manufacturing, subsequent to the utilization of our reduced-cost Vafseo inventory.

Current wording

We began capitalizing our Vafseo costs in March 2024, in connection with the FDA's approval of Vafseo for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Prior to the capitalization of Vafseo inventory costs, such costs were recorded as research and development expenses in the period incurred. We recorded a benefit to cost of product and other revenue for Vafseo of $0.3 million for the three months ended September 30, 2026, due to a tariff refund received during the three months ended September 30, 2026, which was offset by manufacturing and overhead costs as the associated inventory costs such as raw materials, drug substance and drug product conversion costs were expensed previously. If Vafseo inventory sold during the three months ended September 30, 2026 was valued at cost, our cost of product and other revenue for Vafseo would have been $2.5 million. As of September 30, 2026, we had $16.3 million of reduced-cost Vafseo inventory. We expect our cost of product and other revenue for Vafseo will increase, reflecting the full cost of manufacturing, subsequent to the utilization of our reduced-cost Vafseo inventory.

Previous wording

R&D Expenses—R&D expenses were $14.1 million for the three months ended June 30, 2026, compared to $11.0 million for the three months ended June 30, 2025. The increase was primarily driven by increased clinical trial activities related to our mid-stage pipeline assets, which include praliciguat and ebribafusp, as well as higher headcount related costs during the three months ended June 30, 2026.

Current wording

R&D Expenses—R&D expenses were $16.2 million for the three months ended September 30, 2026, compared to $14.9 million for the three months ended September 30, 2025. The increase was primarily driven by increased clinical trial activities related to our mid-stage pipeline assets, which include praliciguat and ebribafusp, during the three months ended September 30, 2026.

Previous wording

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $58.6 million for the six months ended June 30, 2026, compared to $52.3 million for the six months ended June 30, 2025. The increase was driven by increased commercialization activities and headcount related costs during the six months ended June 30, 2026.

Current wording

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $23.5 million for the three months ended September 30, 2026, compared to $29.1 million for the three months ended September 30, 2025. The decrease was driven by lower marketing costs and decreased headcount related costs during the three months ended September 30, 2026.

Previous wording

Restructuring Expenses—Restructuring expenses were $1.9 million for the three months ended June 30, 2026. In June 2026, we modified our commercial approach with the goal of increasing the efficiency and effectiveness of our commercial field team based on the stage of our Vafseo launch and implemented a commercial reorganization, which resulted in a reduction in headcount representing approximately 13% of our workforce prior to the reduction. There were no restructuring expenses for the three months ended June 30, 2025.

Current wording

Restructuring Expenses—Restructuring expenses were $1.3 million for the three months ended September 30, 2026. In July 2026, we implemented a reduction in headcount representing approximately 7% of our workforce prior to the reduction in order to improve our operational efficiency to align with our current priorities. There were no restructuring expenses for the three months ended September 30, 2025.

Previous wording

Other Expense, Net—Other expense, net, was $3.1 million for the three months ended June 30, 2026, compared to $6.9 million for the three months ended June 30, 2025. The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with the Termination and Settlement Agreement with CSL Vifor, or the Vifor Termination Agreement, as well as higher interest income related to our money market funds. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, included in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Form 10-Q for further information.

Current wording

Other Expense, Net—Other expense, net, was $3.1 million for the three months ended September 30, 2026, compared to $4.8 million for the three months ended September 30, 2025. The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with the Termination and Settlement Agreement with CSL Vifor, or the Vifor Termination Agreement. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, included in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Form 10-Q for further information.

Previous wording

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $0.6 million and $7.0 million for the three months ended June 30, 2026 and 2025, respectively.

Current wording

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $0.4 million and $1.5 million for the three months ended September 30, 2026 and 2025, respectively.

Previous wording

Income Tax Expense—Income tax expense was $0.1 million for the three months ended June 30, 2026. There was no income tax expense for the three months ended June 30, 2025.

Current wording

Income Tax Expense—Income tax expense was $0.2 million and $0.6 million for the three months ended September 30, 2026 and 2025, respectively.

Previous wording

Net product revenue was $98.8 million for the six months ended June 30, 2026, compared to $116.3 million for the six months ended June 30, 2025. The decrease was primarily due to lower Auryxia revenues, which were partially offset by higher Vafseo revenues. The lower Auryxia revenues are due to LoE for Auryxia in March 2025 and Teva's entry into the market in March 2026 following approval of its ANDA for a generic version of Auryxia as described in greater detail above.

Current wording

Product Revenue, Net—Net product revenue was $133.6 million for the nine months ended September 30, 2026, compared to $173.0 million for the nine months ended September 30, 2025. The decrease was primarily due to lower Auryxia revenues, which were partially offset by higher Vafseo revenues. The lower Auryxia revenues are due to a decrease in net price as well as a decrease in sales volume of Auryxia due to generic competition as described in greater detail above. As a result of the foregoing, we expect our Auryxia revenues to continue to be significantly lower for the remainder of 2026 and beyond as compared to 2025 Auryxia revenues.

Previous wording

The following table summarizes our product revenue by product for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our product revenue by product for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

(1) Includes the authorized generic version of Auryxia sold and distributed by our AG Distributor during the six months ended June 30, 2026 and 2025

Current wording

(1) Includes the authorized generic version of Auryxia sold and distributed by our AG Distributor during the nine months ended September 30, 2026 and 2025

Previous wording

License, Collaboration and Other Revenue—License, collaboration and other revenue was $2.4 million for the three months ended June 30, 2026, compared to $2.0 million for the three months ended June 30, 2025. The increase was primarily due to revenue recognized in connection with our supply agreement with Medice during the three months ended June 30, 2026.

Current wording

License, Collaboration and Other Revenue—License, collaboration and other revenue was $6.0 million for the nine months ended September 30, 2026, compared to $5.5 million for the nine months ended September 30, 2025. The increase was primarily due to revenue recognized in connection with our supply agreement with Medice during the nine months ended September 30, 2026.

Previous wording

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $10.4 million for the three months ended June 30, 2026 compared to $9.9 million for the three months ended June 30, 2025. The increase was primarily due to an increase in inventory write-downs as a result of excess, obsolescence, scrap or other reasons during the three months ended June 30, 2026.

Current wording

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $29.1 million for the nine months ended September 30, 2026 compared to $26.9 million for the nine months ended September 30, 2025. The increase was primarily due to an increase in inventory write-downs as a result of excess, obsolescence, scrap or other reasons during the nine months ended September 30, 2026.

Previous wording

We began capitalizing our Vafseo costs in March 2024, in connection with the FDA's approval of Vafseo for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Prior to the capitalization of Vafseo inventory costs, such costs were recorded as research and development expenses in the period incurred. Cost of product and other revenue for Vafseo was $1.0 million for the three months ended June 30, 2026, comprised of manufacturing and overhead costs as the associated inventory costs such as raw materials, drug substance and drug product conversion costs were expensed previously. If Vafseo inventory sold during the three months ended June 30, 2026 was valued at cost, our cost of product and other revenue would have been $3.5 million. As of June 30, 2026, we had $18.2 million of reduced-cost Vafseo inventory. We expect our cost of product and other revenue for Vafseo will increase, reflecting the full cost of manufacturing, subsequent to the utilization of our reduced-cost Vafseo inventory.

Current wording

We began capitalizing our Vafseo costs in March 2024, in connection with the FDA's approval of Vafseo for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Prior to the capitalization of Vafseo inventory costs, such costs were recorded as research and development expenses in the period incurred. Cost of product and other revenue for Vafseo was $2.2 million for the nine months ended September 30, 2026, comprised of manufacturing and overhead costs as the associated inventory costs such as raw materials, drug substance and drug product conversion costs were expensed previously. If Vafseo inventory sold during the nine months ended September 30, 2026 was valued at cost, our cost of product and other revenue for Vafseo would have been $12.0 million. As of September 30, 2026, we had $16.3 million of reduced-cost Vafseo inventory. We expect our cost of product and other revenue for Vafseo will increase, reflecting the full cost of manufacturing, subsequent to the utilization of our reduced-cost Vafseo inventory.

Previous wording

R&D Expenses—R&D expenses were $28.9 million for the six months ended June 30, 2026, compared to $20.8 million for the six months ended June 30, 2025. The increase was primarily driven by increased clinical trial activities related to Vafseo and our mid-stage pipeline assets, which include praliciguat and ebribafusp, as well as higher headcount related costs during the six months ended June 30, 2026.

Current wording

R&D Expenses—R&D expenses were $45.0 million for the nine months ended September 30, 2026, compared to $35.7 million for the nine months ended September 30, 2025. The increase was primarily driven by increased clinical trial activities related to Vafseo and our mid-stage pipeline assets, which include praliciguat and ebribafusp, as well as higher headcount related costs during the nine months ended September 30, 2026.

Previous wording

The following table summarizes our external research and development expenses by program, as well as costs not allocated to programs, for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our external research and development expenses by program, as well as costs not allocated to programs, for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $28.2 million for the three months ended June 30, 2026, compared to $26.6 million for the three months ended June 30, 2025. The increase was driven by increased commercialization activities.

Current wording

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $82.1 million for the nine months ended September 30, 2026, compared to $81.4 million for the nine months ended September 30, 2025.

Previous wording

License Expenses—License expenses related to royalties due to Panion for sales of Riona in Japan were $1.6 million for each of the six months ended June 30, 2026 and 2025.

Current wording

License Expenses—License expenses related to royalties due to Panion for sales of Riona in Japan were $2.5 million for each of the nine months ended September 30, 2026 and 2025.

Previous wording

Restructuring Expenses—Restructuring expenses were $1.9 million for the six months ended June 30, 2026 due to our commercial reorganization implemented in June 2026. There were no restructuring expenses for the six months ended June 30, 2025.

Current wording

Restructuring Expenses—Restructuring expenses were $3.3 million for the nine months ended September 30, 2026 due to our commercial reorganization implemented in June 2026 and the reduction in headcount implemented in July 2026. There were no restructuring expenses for the nine months ended September 30, 2025.

Previous wording

Other Expense, Net—Other expense, net, was $7.8 million for the six months ended June 30, 2026, compared to $14.4 million for the six months ended June 30, 2025. The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with the Vifor Termination Agreement, as well as higher interest income related to our money market funds. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, included in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Form 10-Q for further information.

Current wording

Other Expense, Net—Other expense, net, was $10.9 million for the nine months ended September 30, 2026, compared to $19.2 million for the nine months ended September 30, 2025. The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with the Vifor Termination Agreement, as well as higher interest income related to our money market funds. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, included in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Form 10-Q for further information.

Previous wording

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $1.0 million and $6.8 million for the six months ended June 30, 2026 and 2025, respectively.

Current wording

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $1.5 million and $5.4 million for the nine months ended September 30, 2026 and 2025, respectively.

Previous wording

As of June 30, 2026, we had cash and cash equivalents of $155.5 million and restricted cash of $1.7 million.

Current wording

As of September 30, 2026, we had cash and cash equivalents of $159.3 million and restricted cash of $0.9 million.

Previous wording

To date, we have funded our operations principally through sales of our common stock, including through our employee stock purchase plan, product sales, payments received from our collaboration and licensing partners, borrowings under term loans, a working capital payment from CSL Vifor and a royalty transaction. From inception through June 30, 2026, we raised approximately $932.5 million of net proceeds from the sale of equity, including $567.9 million from various underwritten public offerings, $294.6 million from at-the-market, or ATM, offerings, pursuant to our sales agreement with Jefferies LLC, or Jefferies, and prior sales agreements with Cantor Fitzgerald & Co., and $70.0 million from the sale of 7,571,429 shares of common stock to CSL Vifor. During the three and six months ended June 30, 2026, we sold 3,138,107 shares of our common stock under the ATM offering with Jefferies with gross proceeds of $3.4 million ($3.2 million, net of offering expenses).

Current wording

To date, we have funded our operations principally through sales of our common stock, including through our employee stock purchase plan, product sales, payments received from our collaboration and licensing partners, borrowings under term loans, a working capital payment from CSL Vifor and a royalty transaction. From inception through September 30, 2026, we raised approximately $938.9 million of net proceeds from the sale of equity, including $567.9 million from various underwritten public offerings, $301.0 million from at-the-market, or ATM, offerings, pursuant to our sales agreement with Jefferies LLC, or Jefferies, and prior sales agreements with Cantor Fitzgerald & Co., and $70.0 million from the sale of 7,571,429 shares of common stock to CSL Vifor. During the nine months ended September 30, 2026, we sold 8,244,695 shares of our common stock under the ATM offering with Jefferies with gross proceeds of $10.1 million ($9.8 million, net of offering expenses).

Previous wording

We incurred net loss of $8.9 million and $18.0 million during the three and six months ended June 30, 2026, respectively, and generated net income of $0.2 million and $6.4 million during the three and six months ended June 30, 2025, respectively. As of June 30, 2026 and December 31, 2025, we had an accumulated deficit of $1.7 billion.

Current wording

We incurred a net loss of $14.4 million and $32.3 million during the three and nine months ended September 30, 2026, respectively, and generated net income of $0.5 million and $6.9 million during the three and nine months ended September 30, 2025, respectively. As of September 30, 2026 and December 31, 2025, we had an accumulated deficit of $1.7 billion.

Previous wording

We had exclusive rights under a series of patents and patent applications to commercialize Auryxia in the U.S. that protected us from generic drug competition until March 2025. Following LoE, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S. On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia. As a result of Teva's entry into the market, we have experienced, and we expect to continue to experience, a significant reduction in the volume of Auryxia sales. We expect the ongoing sales of generic versions of Auryxia, including by Teva and our AG Distributor, and of any additional generic versions of Auryxia that may be approved, will continue to have a significant adverse impact on our revenue. However, the extent of impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics that enter the market, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

Current wording

We had exclusive rights under a series of patents and patent applications to commercialize Auryxia in the U.S. that protected us from generic drug competition until March 2025. Following LoE, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S. On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia. As a result of Teva's entry into the market, we have experienced a significant reduction in the volume of Auryxia sales. We expect the ongoing sales of generic versions of Auryxia, including by Teva and our AG Distributor, and of any additional generic versions of Auryxia that may be approved, will continue to have a significant adverse impact on our revenue. However, the extent of impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations and other customers, including specialty distributors, the timing and number of additional generics that enter the market, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

Previous wording

As a result of the Vifor Termination Agreement, we concluded that CSL Vifor no longer met the definition of a customer and, therefore, the arrangement should not be considered a revenue contract with a customer under ASC 606, Revenue from Contracts with Customers. We therefore determined that the $43.3 million received from Vifor in connection with the Vifor License Agreement and related investment agreements should be classified as debt and we are amortizing such amount using the effective interest method over the Settlement Royalty Term. The liability related to settlement royalties and the amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. The annual effective interest rate as of June 30, 2026 was 9.9% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss). We recognized interest expense related to the liability related to settlement royalties of $1.7 million and $5.3 million for the three and six months ended June 30, 2026, respectively, and $5.4 million and $10.8 million during the three and six months ended June 30, 2025, respectively. As of June 30, 2026, $9.6 million and $60.8 million of the liability related to settlement royalties is classified as a current and non-current liability, respectively.

Current wording

As a result of the Vifor Termination Agreement, we concluded that CSL Vifor no longer met the definition of a customer and, therefore, the arrangement should not be considered a revenue contract with a customer under ASC 606, Revenue from Contracts with Customers. We therefore determined that the $43.3 million received from CSL Vifor in connection with the Vifor License Agreement and related investment agreements should be classified as debt and we are amortizing such amount using the effective interest method over the Settlement Royalty Term. The liability related to settlement royalties and the amortization are based on our current estimates of future royalties expected to be paid over the life of the arrangement. The annual effective interest rate as of September 30, 2026 was 12.8% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss). We recognized interest expense related to the liability related to settlement royalties of $2.3 million and $7.6 million for the three and nine months ended September 30, 2026, respectively, and $3.9 million and $14.7 million during the three and nine months ended September 30, 2025, respectively. As of September 30, 2026, $5.6 million and $65.1 million of the liability related to settlement royalties is classified as a current and non-current liability, respectively.

Previous wording

The Working Capital Fund is considered a debt arrangement with zero coupon interest, and we impute interest on the Working Capital Fund liability at a rate of 15.0% per annum. As of June 30, 2026, $10.7 million and $21.2 million of the Working Capital Fund liability is classified as a current and non-current liability, respectively, based on management’s estimated timing of the repayment of the Working Capital Fund liability to CSL Vifor.

Current wording

The Working Capital Fund is considered a debt arrangement with zero coupon interest, and we impute interest on the Working Capital Fund liability at a rate of 15.0% per annum. As of September 30, 2026, $9.8 million and $20.3 million of the Working Capital Fund liability is classified as a current and non-current liability, respectively, based on management’s estimated timing of the repayment of the Working Capital Fund liability to CSL Vifor.

Previous wording

We received $44.8 million from HCR, net of certain transaction expenses, which we recorded as a liability at the transaction date. We amortize the liability related to the sale of future royalties using the effective interest method over the life of the arrangement. The annual effective interest rate as of June 30, 2026 was 0%. We retain the right to receive all potential future regulatory milestones for Vafseo under the TPC Agreement. We recorded non-cash royalty revenue of $0.4 million and $0.8 million during the three and six months ended June 30, 2026, respectively, and $0.5 million and $0.9 million during the three and six months ended June 30, 2025, respectively. As of June 30, 2026, $1.5 million and $50.0 million of the liability related to the sale of future royalties is classified as a current and non-current liability, respectively.

Current wording

We received $44.8 million from HCR, net of certain transaction expenses, which we recorded as a liability at the transaction date. We amortize the liability related to the sale of future royalties using the effective interest method over the life of the arrangement. The annual effective interest rate as of September 30, 2026 was 0%. We retain the right to receive all potential future regulatory milestones for Vafseo under the TPC Agreement. We recorded non-cash royalty revenue of $0.4 million and $1.2 million during the three and nine months ended September 30, 2026, respectively, and $0.5 million and $1.3 million during the three and nine months ended September 30, 2025, respectively. As of September 30, 2026, $1.5 million and $49.6 million of the liability related to the sale of future royalties is classified as a current and non-current liability, respectively.

Previous wording

As of June 30, 2026, in connection with the Cambridge Lease, we had $1.7 million in a letter of credit outstanding.

Current wording

As of September 30, 2026, in connection with the Waltham Lease, we had $0.9 million in a letter of credit outstanding.

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Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

We lease 43,474 square feet of office space and laboratory space under the Waltham Lease. We relocated our corporate headquarters to Waltham in September 2026.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

2026, we announced the initiation of a Phase 2 basket study to evaluate ebribafusp in IgA Nephropathy, or IgAN, C3 Glomerulopathy, or C3G, and Lupus Nephritis, or LN.

Previous report — wording carried elsewhere

Value Measurements, and Note 7, Indebtedness, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the warrant liability.

Previous report — wording carried elsewhere

In January 2026, we entered into the Waltham Lease. We intend to relocate our corporate headquarters to Waltham in September 2026.