Akebia Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 5, 2026.
View on SEC.govAbout 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.
Jun 30, 2026 · Filed Aug 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 filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-07.
0001517022-26-000039
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 OperationsThe 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 156 previous paragraphs and 181 current paragraphs.
106 unchanged; 45 reworded; 16 added; 4 removed; 1 previous and 14 current paragraphs rearranged.
Tables are not compared: 4 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 (16)
Current report
Interim Analysis of Vafseo Outcomes In Center Experience (VOICE) Trial
Current report
In June 2026, we and U.S. Renal Care, or USRC, Kidney Research announced the results of a planned interim analysis of the VOICE trial and that it met the predefined stopping criteria by establishing non-inferiority and superiority of the primary composite endpoint and the decision by USRC Kidney Research to stop the trial on this basis. The primary investigator made the decision to stop the trial after a recommendation from the Independent Data Monitoring Committee and Trial Steering Committee, based on an interim analysis of data from the trial as of the June 1, 2026 data cutoff date meeting the prescribed stopping criteria.
Current report
Increase to Authorized Shares
Current report
In June 2026, we filed a Certificate of Amendment to our Ninth Amended and Restated Certificate of Incorporation, which (i) increased the number of authorized shares of capital stock from 375,000,000 to 525,000,000 and (ii) increased the number of authorized shares of common stock, par value $0.00001 per share, from 350,000,000 to 500,000,000.
Current report
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 report
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 report
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 report
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 report
Comparison of the Six Months Ended June 30, 2026 and 2025
Current report
*Percentage change not meaningful.
Current report
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 report
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 report
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 report
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 report
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 report
Net cash used in investing activities was $4.1 million for the six months ended June 30, 2026 and was comprised of the additional upfront payment of $3.0 million paid to Q32 as well as purchases of equipment.
Removed paragraphs (4)
Previous report
Initiation of Phase 2 Trial in FSGS
Previous report
In December 2025, we dosed our first patient in a Phase 2 clinical trial of praliciguat for the treatment of biopsy-confirmed FSGS. As a result, in February 2026, pursuant to the terms of a License Agreement, as amended, dated June 3, 2021, by and between us and Cyclerion, or the Cyclerion Agreement, upon such dosing, we paid a $1.0 million regulatory milestone payment to Cyclerion.
Previous report
See Note 10, Commitments and Contingencies, 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 Cyclerion Agreement.
Previous report
Auryxia lost exclusivity in the U.S. in March 2025, which we expect to have a negative impact on future Auryxia revenue. 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, which has subsequently entered the market. We expect Teva's entry into the market, and the entry of any additional generic versions of Auryxia that may be approved in addition to our AG Distributor, will adversely impact our revenue. However, the 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.
Reworded paragraphs (45)
Previous wording
We have established the Company as a leader in the kidney community and believe our cross-organizational expertise in kidney disease positions us for success. Chronic kidney disease, or CKD, is a condition in which the kidneys are progressively damaged to the point that they cannot properly filter the blood circulating in the body. This damage causes waste products to build up in the patient’s blood, leading to other health problems, including anemia, cardiovascular disease and bone disease. CKD significantly impacts the United States, or U.S., healthcare system, potentially affecting approximately 35.5 million patients. In 2022, in the U.S. treating Medicare beneficiaries with CKD cost an estimated $95.7 billion, and treating people on dialysis cost an estimated $45.3 billion. Our two commercial products address certain complications of kidney disease.
Current wording
We have established the Company as a leader in the kidney community and believe our cross-organizational expertise in kidney disease positions us for success. Chronic kidney disease, or CKD, is a condition in which the kidneys are progressively damaged to the point that they cannot properly filter the blood circulating in the body. This damage causes waste products to build up in the patient’s blood, leading to other health problems, including anemia, cardiovascular disease and bone disease. Our two commercial products address certain complications of kidney disease.
Previous wording
Vafseo® (vadadustat) is an orally administered medicine that was approved by the U.S. Food and Drug Administration, or the FDA, in March 2024 for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. The current U.S. market opportunity for the treatment of anemia due to CKD in patients with dialysis is approximately $1 billion based on current erythropoiesis stimulating agent, or ESA, pricing. Vafseo is the only oral hypoxia inducible factor, or HIF, based treatment available in the U.S. Vafseo entered the market in January 2025, at which time we had commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. Throughout 2025, we worked closely with dialysis organizations as their medical teams developed, implemented and operationalized protocols to enable prescribers to write Vafseo prescriptions for clinically appropriate patients. Currently, approximately 290,000 dialysis patients in the U.S. have prescribing access to Vafseo.
Current wording
Vafseo® (vadadustat) is an orally administered medicine that was approved by the U.S. Food and Drug Administration, or the FDA, in March 2024 for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Vafseo is the only oral hypoxia inducible factor, or HIF, based treatment available in the U.S. Vafseo entered the market in January 2025.
Previous wording
Our mid-stage rare kidney disease pipeline assets, praliciguat and AKB-097, 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., 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.
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 known as ADX-097 (now referred to as AKB-097, generic name ebribafusp), an anti-C3d-Factor H fusion protein complement inhibitor. AKB-097 is a potential next-generation complement inhibitor, and we believe AKB-097 has applicability across a wide range of complement-mediated rare kidney diseases. AKB-097 is intended to provide targeted regulation of complement activation at sites of tissue injury while limiting systemic complement inhibition. We expect to initiate a Phase 2 basket study in the second half of 2026 to evaluate AKB-097 for the following indications: IgA Nephropathy, or IgAN; C3 Glomerulopathy, or C3G; and Lupus Nephritis, or LN.
Current 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
Previous wording
We generate product revenue from commercial sales of Auryxia and Vafseo to a limited number of customers, including dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our authorized generic distribution partner, Mylan Therapeutics, Inc., or AG Distributor. Our net product revenue includes many variables, including judgments and estimates of discounts, rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year.
Current wording
We generate product revenue from commercial sales of Auryxia and Vafseo to a limited number of customers, including dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our authorized generic distribution partner for Auryxia, Mylan Therapeutics, Inc., or AG Distributor. Our net product revenue includes many variables, including judgments and estimates of discounts, rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year.
Previous wording
We expect to continue to generate revenue from our collaboration, license and supply agreements with Medice, Tanabe Pharma Corporation, or TPC, 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., 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
Cost of product and other revenue includes costs closely correlated or directly related to the costs to manufacture commercial drug substance and drug product, including at our contract manufacturing organizations, or CMOs, as well as indirect costs. Direct and indirect costs include fees for packaging, shipping, insurance and quality assurance, idle capacity charges, changes in reserves for excess inventory, write-offs for inventory that fails to meet specifications or is otherwise no longer suitable for commercial sale, including scrap, changes in a firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S. and Japan product sales recognized during the period.
Current wording
Cost of product and other revenue includes costs closely correlated or directly related to the costs to manufacture commercial drug substance and drug product, including at our contract development and manufacturing organizations, or CDMOs, as well as indirect costs. Direct and indirect costs include fees for packaging, shipping, insurance and quality assurance, idle capacity charges, changes in reserves for excess inventory, write-offs for inventory that fails to meet specifications or is otherwise no longer suitable for commercial sale, including scrap, changes in a firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S. and Japan product sales recognized during the period.
Previous wording
•the cost of acquiring, developing and manufacturing clinical trial materials through CMOs;
Current wording
•the cost of acquiring, developing and manufacturing clinical trial materials through CDMOs;
Previous wording
•acquired in process research and development costs associated with the acquisition of Q32's clinical stage development asset now referred to as AKB-097; and
Current wording
•acquired in process research and development costs associated with the acquisition of Q32's clinical stage development asset known as ebribafusp; and
Previous wording
From inception through March 31, 2026, we have incurred $1.8 billion in R&D expenses. We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Auryxia, Vafseo, praliciguat, AKB-097, AKB-9090 and any other product or product candidate, including those that may be in-licensed or acquired.
Current wording
From inception through June 30, 2026, we have incurred $1.8 billion in R&D expenses. We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Vafseo, praliciguat, ebribafusp, AKB-9090 and any other product or product candidate, including those that may be in-licensed or acquired.
Previous wording
A significant portion of our R&D costs have been external costs, which we track on a program-by-program basis as well as costs related to possible new manufacturing processes and methods associated with our commercial products. These external costs include fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials and costs related to acquiring and manufacturing clinical trial materials, including costs paid to CMOs to manufacture clinical trial materials.
Current wording
A significant portion of our R&D costs have been external costs, which we track on a program-by-program basis as well as costs related to possible new manufacturing processes and methods associated with our commercial products. These external costs include fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials and costs related to acquiring and manufacturing clinical trial materials, including costs paid to CDMOs to manufacture clinical trial materials.
Previous wording
Each of our products and product candidates has technical, clinical, regulatory, and commercial risk, including those discussed more fully under the heading “Risk Factors” in Part II, Item 1A of this Form 10-Q. A change in the outcome of any of the variables with respect to the development of Auryxia, Vafseo or any other product or product candidate could result in a significant change in the costs and timing associated with that development.
Current wording
Each of our products and product candidates has technical, clinical, regulatory, and commercial risk, including those discussed more fully under the heading “Risk Factors” in Part II, Item 1A of this Form 10-Q. A change in the outcome of any of the variables with respect to the development of Vafseo, praliciguat, ebribafusp and AKB-9090 and any other product or product candidate, could result in a significant change in the costs and timing associated with that development.
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 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.
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
Previous wording
On April 9, 2026, the Company extended the term of the Cambridge Lease with respect to the laboratory space from September 11, 2026 to October 31, 2026. See Note 7, Subsequent Events, for further information
Current 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.
Previous wording
Net product revenue was $52.0 million for the three months ended March 31, 2026, compared to $55.8 million for the three months ended March 31, 2025. The decrease was primarily due to lower Auryxia revenues, which were partially offset by higher Vafseo revenues.
Current 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.
Previous wording
License, Collaboration and Other Revenue—License, collaboration and other revenue was $1.6 million for the three months ended March 31, 2026, compared to $1.5 million for the three months ended March 31, 2025.
Current 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.
Previous wording
Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $12.3 million for the three months ended March 31, 2026 compared to $7.6 million for the three months ended March 31, 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 March 31, 2026.
Current 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.
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 $1.4 million for the three months ended March 31, 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 March 31, 2026 was valued at cost, our cost of product and other revenue would have been $6.2 million. As of March 31, 2026, we had $24.6 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 $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.
Previous wording
R&D Expenses—R&D expenses were $14.8 million for the three months ended March 31, 2026, compared to $9.8 million for the three months ended March 31, 2025. The increase was primarily driven by increased clinical trial activities related to praliciguat and AKB-9090 as well as higher headcount related costs during the three months ended March 31, 2026.
Current 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.
Previous wording
License Expenses—License expenses related to royalties due to Panion for sales of Riona in Japan were $0.7 million for each of the three months ended March 31, 2026 and 2025.
Current wording
License Expenses—License expenses related to royalties due to Panion for sales of Riona in Japan were $0.9 million for each of the three months ended June 30, 2026 and 2025.
Previous wording
Other Expense, Net—Other expense, net, was $4.7 million for the three months ended March 31, 2026, compared to $7.6 million for the three months ended March 31, 2025. The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with a 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 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.
Previous wording
Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $0.5 million and $0.2 million for the three months ended March 31, 2026 and 2025, respectively.
Current 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.
Previous wording
Selling, General and Administrative Expenses—Selling, general and administrative expenses were $30.4 million for the three months ended March 31, 2026, compared to $25.7 million for the three months ended March 31, 2025. The increase was driven by higher headcount related costs during the three months ended March 31, 2026.
Current 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.
Previous wording
As of March 31, 2026, we had cash and cash equivalents of $162.6 million and restricted cash of $1.7 million.
Current wording
As of June 30, 2026, we had cash and cash equivalents of $155.5 million and restricted cash of $1.7 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 also referred to as a Working Capital Fund liability and a royalty transaction. From inception through March 31, 2026, we raised approximately $929.2 million of net proceeds from the sale of equity, including $567.9 million from various underwritten public offerings, $291.3 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 months ended March 31, 2026, we did not sell any shares of our common stock under the ATM offering with Jefferies.
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 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).
Previous wording
We incurred net loss of $9.1 million and generated net income of $6.1 million during the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $1.7 billion.
Current 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.
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, which has subsequently entered the market. We expect Teva's entry into the market, and the entry of any additional generic versions of Auryxia that may be approved in addition to our AG Distributor, will adversely impact our revenue. However, the 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, 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.
Previous wording
We believe our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are sufficient to fund our current operating plan for at least two years, including to commercialize Vafseo and Auryxia and advance our existing programs. However, if our operating performance deteriorates significantly from the levels expected in our long-term operating plan, including if we do not achieve our future anticipated Vafseo revenue projections, it would have an adverse effect on our liquidity and capital resources and could affect our ability to achieve and maintain profitability or continue as a going concern in the future. In addition, we may also seek to sell additional private or public equity, enter into new debt transactions, explore potential strategic transactions or a combination of these approaches or other strategic alternatives. If we raise additional funds by issuing equity securities, our shareholders would experience dilution. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Additional financing may not be available to us in amounts or on terms acceptable to us, if at all. If we are unable to raise additional capital in sufficient amounts when needed or on attractive terms, we may not be able to pursue development and commercial activities related to Auryxia and Vafseo, or any additional products and product candidates, including those that may be in-licensed or acquired. Any of these events could significantly harm our business, financial condition and prospects.
Current wording
If we are unable to refinance our senior secured term loan, or our operating performance deteriorates significantly from the levels expected in our long-term operating plan, including if we do not achieve our future anticipated revenue projections from Vafseo, it would have an adverse effect on our liquidity and capital resources, and we would be required to obtain additional financing to fund our operating plan or continue as a going concern in the future. In addition, we may also seek to sell additional private or public equity, enter into new debt transactions, explore potential strategic transactions or a combination of these approaches or other strategic alternatives. If we raise additional funds by issuing equity securities, our shareholders would experience dilution. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Additional financing may not be available to us in amounts or on terms acceptable to us, if at all. If we are unable to raise additional capital in sufficient amounts when needed or on attractive terms, we may not be able to pursue development and commercial activities related to Vafseo, or any additional products and product candidates, including those that may be in-licensed or acquired. Any of these events could significantly harm our business, financial condition and prospects.
Previous wording
On February 3, 2025, we and Kreos entered into a Second Amendment to the BlackRock Credit Agreement, or the Second Amendment, which, among other things, extended the expiry date of Tranche C from December 31, 2024 to the Tranche C Closing Date, or the Extended Tranche C. Tranche C was available subject to receipt of a certain amount of cumulative gross cash proceeds after the Closing Date in the form of equity or equity linked securities in one or more series of transactions. The terms of the Extended Tranche C are substantially similar to the terms of the original Tranche C, however, interest accrued on the Extended Tranche C as if it was advanced on December 31, 2024.
Current wording
On February 3, 2025, we and Kreos entered into a Second Amendment to the BlackRock Credit Agreement, which, among other things, extended the expiry date of Tranche C from December 31, 2024 to the Tranche C Closing Date, or the Extended Tranche C. Tranche C was available subject to receipt of a certain amount of cumulative gross cash proceeds after the Closing Date in the form of equity or equity linked securities in one or more series of transactions. The terms of the Extended Tranche C are substantially similar to the terms of the original Tranche C, however, interest accrued on the Extended Tranche C as if it was advanced on December 31, 2024.
Previous wording
The Term Loan Facility accrues interest at a floating annual rate equal to the sum of (i) term Secured Overnight Financing Rate, or SOFR, for a tenor of one month (subject to a floor of 4.25% per annum) plus (ii) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate). During the continuance of any payment event of default the interest rate on such overdue sum will automatically increase by an additional 3.0% per annum, and may be subject to an additional late fee of 2.0% of such overdue sum.
Current wording
The Term Loan Facility accrues interest at a floating annual rate equal to the sum of (i) term Secured Overnight Financing Rate for a tenor of one month (subject to a floor of 4.25% per annum) plus (ii) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate). During the continuance of any payment event of default the interest rate on such overdue sum will automatically increase by an additional 3.0% per annum, and may be subject to an additional late fee of 2.0% of such overdue sum.
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 March 31, 2026 was 21.2% 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 $3.6 million for the three months ended March 31, 2026. As of March 31, 2026, $15.4 million and $54.8 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 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.
Previous wording
Pursuant to the terms of the Vifor Termination Agreement, and generally consistent with the terms of the Vifor License Agreement, we agreed to repay the Working Capital Fund to CSL Vifor through quarterly tiered royalty payments ranging from 8% to 14% of our net sales of Vafseo in the U.S., or the WCF Royalty Payments. The WCF Royalty Payments commenced on July 1, 2025, and will continue until the earlier of (i) the cumulative total of the WCF Royalty Payments equals $40.0 million, or (ii) May 31, 2028, or the WCF Royalty Term. The WCF Royalty Payments are subject to certain minimum true-up milestones.
Current wording
Pursuant to the terms of the Vifor Termination Agreement, and generally consistent with the terms of the Vifor License Agreement, we agreed to repay the Working Capital Fund to CSL Vifor through quarterly tiered royalty payments ranging from 8% to 14% of our net sales of Vafseo in the U.S., or the WCF Royalty Payments. The WCF Royalty Payments commenced on July 1, 2025, and will continue until the earlier of (i) the cumulative total of the WCF Royalty Payments equals $40.0 million, or (ii) May 31, 2028. The WCF Royalty Payments are subject to certain minimum true-up milestones.
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 March 31, 2026, $23.4 million and $16.4 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 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.
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 March 31, 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 $0.3 million and $0.4 million during the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, $1.4 million and $50.4 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 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.
Previous wording
As of March 31, 2026, in connection with our office and laboratory space in Cambridge, Massachusetts, or the Cambridge Lease, we had $1.7 million in a letter of credit outstanding.
Current wording
As of June 30, 2026, in connection with the Cambridge Lease, we had $1.7 million in a letter of credit outstanding.
Previous wording
In June 2021, we entered into the Cyclerion Agreement, as amended in December 2024, under which we obtained an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral soluble guanylate cyclase stimulator.
Current wording
In June 2021, we entered into a license agreement, or the Cyclerion Agreement, with Cyclerion, as amended in December 2024, under which we obtained an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral soluble guanylate cyclase stimulator.
Previous wording
On November 28, 2025, or the APA Closing Date, we entered into an Asset Purchase Agreement, or the Q32 Purchase Agreement, with Q32, pursuant to which we purchased and assumed from Q32 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 known as ADX-097 (now referred to as AKB-097) worldwide for the treatment, prevention or diagnosis of any disease or condition in humans. AKB-097, which has been evaluated in a Phase 1 clinical trial in healthy volunteers, in a tissue-targeted C3d-Factor H fusion protein complement inhibitor with the potential to treat rare kidney diseases.
Current wording
On November 28, 2025, or the APA Closing Date, we entered into an Asset Purchase Agreement, or the Q32 Purchase Agreement, with Q32, pursuant to which we purchased and assumed from Q32 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), worldwide for the treatment, prevention or diagnosis of any disease or condition in humans. Ebribafusp, which has been evaluated in a Phase 1 clinical trial in healthy volunteers, in a tissue-targeted C3d-Factor H fusion protein complement inhibitor with the potential to treat rare kidney diseases.
Previous wording
Under the terms of the Q32 Purchase Agreement, we (i) made an upfront payment of $7.0 million on the APA Closing Date, (ii) will make an additional upfront payment of $3.0 million on the six-month anniversary of the APA Closing Date, (iii) will make certain milestone payments upon the achievement of specified development and regulatory milestone events related to AKB-097 up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the earlier of initiation of a Phase 2 clinical trial and December 31, 2026, (iv) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the net sales of AKB-097 up to an aggregate amount equal to $487.5 million, and (v) will make certain royalty payments based on the net sales of AKB-097 with royalty percentage tiers ranging from the low single digits to mid-teen percentages. The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last-to-expire valid claim of any transferred patent right that covers such product in such country, and (b) the tenth anniversary of the first commercial sale of such product.
Current wording
Under the terms of the Q32 Purchase Agreement, we (i) made an upfront payment of $7.0 million on the APA Closing Date, (ii) made an additional upfront payment of $3.0 million on the six-month anniversary of the APA Closing Date, (iii) will make certain milestone payments upon the achievement of specified development and regulatory milestone events related to ebribafusp up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the earlier of initiation of a Phase 2 clinical trial and December 31, 2026, (iv) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the net sales of ebribafusp up to an aggregate amount equal to $487.5 million, and (v) will make certain royalty payments based on the net sales of ebribafusp with royalty percentage tiers ranging from the low single digits to mid-teen percentages. The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last-to-expire valid claim of any transferred patent right that covers such product in such country, and (b) the tenth anniversary of the first commercial sale of such product.
Previous wording
We enter into agreements in the normal course of business with various vendors, which are generally cancellable upon notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of service providers, up to the date of cancellation. In addition, we contract with various organizations to conduct R&D activities with remaining contract costs to us of approximately $81.5 million as of March 31, 2026. The scope of the services under these R&D contracts can be modified upon mutual agreement of the parties, and the contracts or scope of services can be cancelled by us upon written notice. In some instances, the contracts may be cancelled by the third party upon written notice.
Current wording
We enter into agreements in the normal course of business with various vendors, which are generally cancellable upon notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including non-cancellable obligations of service providers, up to the date of cancellation. In addition, we contract with various organizations to conduct R&D activities with remaining contract costs to us of approximately $75.9 million as of June 30, 2026. The scope of the services under these R&D contracts can be modified upon mutual agreement of the parties, and the contracts or scope of services can be cancelled by us upon written notice. In some instances, the contracts may be cancelled by the third party upon written notice.
Previous wording
Net cash used in operating activities was $21.2 million for the three months ended March 31, 2026 and consisted of a net loss of $9.1 million and net non-cash adjustments of $12.4 million, including a change in fair value of the warrant liability of $0.5 million, and a reduction of $24.5 million in working capital.
Current wording
Net cash used in operating activities was $17.7 million for the six months ended June 30, 2026 and consisted of a net loss of $18.0 million and net non-cash adjustments of $21.1 million, including a change in fair value of the warrant liability of $1.0 million, and a reduction of $20.8 million in working capital.
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Rearranged current paragraphs (14)
Current report — wording carried from 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.
Current report — wording carried from 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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes our product revenue by product for the six months ended June 30, 2026 and 2025 (in thousands):
Current report — wording carried from elsewhere
(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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
(1) See the section titled "Business Overview" for details on our current product portfolio and development pipeline.
Current report — wording carried from elsewhere
We expect to incur significant R&D expenses in future periods in support of ongoing or planned studies with respect to the development of our product candidates.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
We believe our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are sufficient to fund our current operating plan for at least two years. This estimate is contingent upon us refinancing our outstanding debt under our senior secured term loan facility to defer the payment of principal, which would otherwise commence on January 1, 2027. See Note 7, Indebtedness, to our unaudited condensed consolidated financial statements in Part I, Item 1. Financial Statements of this Form 10-Q for additional information regarding our obligations under our senior secured term loan facility. If we are unable to execute such refinancing on favorable terms or at all, we believe that our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues will be sufficient to enable us to fund our current operating plan for at least 12 months from the filing of this Quarterly Report on Form 10-Q.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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 20, 2025. Following LoE, since 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, which has subsequently entered the market. We expect Teva's entry into the market, and the entry of any additional generic versions of Auryxia that may be approved in addition to our AG Distributor, will adversely impact our revenue. However, the 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, 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.