Akebia Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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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, 2025 · Filed Aug 7, 2025
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 2025-03-31; filed 2025-05-08.
0001628280-25-023460
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001628280-25-038600
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 177 current paragraphs.
115 unchanged; 38 reworded; 10 added; 1 removed; 2 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 (10)
Current report
We are committed to pursuing a path for label expansion for Vafseo for CKD non-dialysis dependent patients. We continue to work towards our goal to initiate VALOR, a Phase 3 cardiovascular outcome study of approximately 1,500 U.S. subjects with late-stage CKD anemia not on dialysis with a comparator to ESA, by the end of 2025 and recently requested a Type-C meeting with the FDA. The study will be one part of what we believe will be a robust data package that will likely include data from the 1,700 U.S. patients in the global Phase 3 PRO 2 TECT program, as well as safety data from the commercial use of Vafseo in the U.S. in dialysis patients, and data on the use of Vafseo in Japan in dialysis and non-dialysis patients where Vafseo has been in the market since 2020.
Current report
On July 21, 2025, the Warrant Holder exercised its option to purchase 2,115,384 shares of our common stock under the Initial Warrant on a cashless basis at an exercise price per share of $1.30. On July 23, 2025, as a result of the cashless exercise, we issued 1,408,588 shares to the Warrant Holder. See Note 17, Subsequent Events, 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.
Current report
Selling, General and Administrative Expenses—Selling, general and administrative expenses were $26.6 million for the three months ended June 30, 2025, compared to $26.9 million for the three months ended June 30, 2024. The decrease was largely due to lower costs associated with our patient assistance program related to Auryxia and decreased professional fees, partially offset by marketing costs in connection with the Vafseo U.S. launch during the three months ended June 30, 2025.
Current report
Other Expense, Net—Other expense, net, was $6.9 million for the three months ended June 30, 2025, compared to $2.2 million for the three months ended June 30, 2024. The increase was primarily due to non-cash interest expense related to the settlement royalty liability in connection with the Termination and Settlement Agreement entered into on July 10, 2024 between us and CSL Vifor, or the Vifor Termination Agreement, partially offset by 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, 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 our arrangements with CSL Vifor.
Current report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
License, Collaboration and Other Revenue—License, collaboration and other revenue was $3.6 million for the six months ended June 30, 2025, compared to $4.0 million for the six months ended June 30, 2024. The decrease was primarily due to revenue recognized in connection with our supply agreement with MTPC during the six months ended June 30, 2024.
Current report
R&D Expenses—R&D expenses were $20.8 million for the six months ended June 30, 2025, compared to $17.4 million for the six months ended June 30, 2024. The increase was primarily due to clinical trial activities related to Vafseo as well as our other programs.
Current report
Selling, General and Administrative Expenses—Selling, general and administrative expenses were $52.3 million for the six months ended June 30, 2025, compared to $52.4 million for the six months ended June 30, 2024. The decrease was largely due to lower costs associated with our patient assistance program related to Auryxia and decreased professional fees, partially offset by marketing costs in connection with the Vafseo U.S. launch during the six months ended June 30, 2025.
Current report
Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $6.8 million and $2.2 million for the six months ended June 30, 2025 and 2024, respectively.
Current report
On July 21, 2025, the Warrant Holder exercised its option to purchase 2,115,384 shares of our common stock under the Initial Warrant on a cashless basis at an exercise price per share of $1.30. On July 23, 2025, as a result of the cashless exercise, we issued 1,408,588 shares to the Warrant Holder. See Note 17, Subsequent Events, 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.
Removed paragraphs (1)
Previous report
Selling, General and Administrative Expenses—Selling, general and administrative expenses were $25.7 million for the three months ended March 31, 2025, compared to $25.4 million for the three months ended March 31, 2024.
Reworded paragraphs (38)
Previous wording
Vafseo 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. Shipment of Vafseo commenced in January 2025. We have commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. 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 ESA pricing and Vafseo is the only oral HIF-based treatment available in the U.S.
Current wording
Vafseo 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. Shipment of Vafseo commenced in January 2025. We have commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. 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 and Vafseo is the only oral HIF-based treatment available in the U.S.
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 lost exclusivity, or LoE. We believe the dynamics of Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE situations, but the impact of LoE 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 and the pricing of generics and other products on the market that compete with Auryxia.
Current wording
Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE situations, but the impact of LoE 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 and the pricing of generics and other products on the market that compete with Auryxia.
Previous wording
Ferric citrate hydrate has also been approved in Japan, and is marketed and sold by our Japanese sublicensee, Japan Tobacco, Inc., and its subsidiary, Torii Pharmaceutical Co., Ltd., collectively, JT and Torii, as an oral treatment for the improvement of hyperphosphatemia in patients with CKD, including DD-CKD and NDD-CKD, and for the treatment of adult patients with IDA under the trade name as Riona in Japan. Averoa SAS, or Averoa, has an exclusive license to develop and commercialize ferric citrate in the European Economic Area, or EEA, Turkey, Switzerland, the UK, the Balkans and certain countries in Eastern Europe and the Middle East. Averoa applied for marketing authorization for ferric citrate in Europe in April 2024. In March 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the European Commission, or EC, to approve Averoa’s marketing authorization. The final EC decision is expected on June 1, 2025.
Current wording
Ferric citrate hydrate has also been approved in Japan, and is marketed and sold by our Japanese sublicensee, Japan Tobacco, Inc., and its subsidiary, Torii Pharmaceutical Co., Ltd., collectively, JT and Torii, as an oral treatment for the improvement of hyperphosphatemia in patients with CKD, including DD-CKD and NDD-CKD, and for the treatment of adult patients with IDA under the trade name Riona in Japan. Averoa SAS, or Averoa, has an exclusive license to develop and commercialize ferric citrate in the European Economic Area, or EEA, Turkey, Switzerland, the UK, the Balkans and certain countries in Eastern Europe and the Middle East. Averoa applied for marketing authorization for ferric citrate in Europe in April 2024. In March 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the European Commission, or EC, to approve Averoa’s marketing authorization. The EC granted marketing authorization in June 2025.
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 20, 2025. Following LoE, in March 2025, our AG Partner began to sell and distribute an authorized generic version of Auryxia in the U.S. The impact of LoE 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 and the pricing of generics and other products on the market that compete with Auryxia. In addition, we believe the dynamics of Auryxia reimbursement being included in the ESRD bundle and Auryxia LoE could result in the buying pattern of certain customers in future years being different than their historical practices.
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 20, 2025. Following LoE, since March 2025, our AG Partner has been selling an authorized generic version of Auryxia in the U.S. The impact of LoE 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 and the pricing of generics and other products on the market that compete with Auryxia.
Previous wording
•costs associated with the pre-launch inventory build for Vafseo in the U.S. prior to the FDA approval in March 2024 and in Europe prior to the European Commission, or EC, approval in April 2023.
Current wording
•costs associated with the pre-launch inventory build for Vafseo in the U.S. prior to the FDA approval in March 2024.
Previous wording
License expenses relates to royalties due to Panion & BF Biotech, Inc., or Panion, for sales of Auryxia in the U.S. and Riona in Japan.
Current wording
License expenses relate to royalties due to Panion & BF Biotech, Inc., or Panion, for sales of Auryxia in the U.S. and Riona in Japan.
Previous wording
Holder, we issued a warrant to the Warrant Holder to purchase 1,153,846 shares of our common stock, at an exercise price per share of $1.30. The warrant shall be exercisable for eight years from the date of issuance.
Current wording
On February 3, 2025, in connection with the drawdown of the Extended Tranche C Loan, in accordance with the warrant agreement, dated as of January 29, 2024, between the Company and Kreos Capital VII Aggregator SCSp, or the Warrant Holder, we issued a warrant to the Warrant Holder to purchase 1,153,846 shares of our common stock, at an exercise price per share of $1.30. The warrant shall be exercisable for eight years from the date of issuance.
Previous wording
On September 3, 2024, in connection with the filing of a new shelf registration statement on Form S-3, we filed a prospectus related to our amended and restated sales agreement with Jefferies LLC (which amended and restated the prior sales agreement), pursuant to which we are able to offer and sell up to $75.0 million of our common stock at current market prices from time to time. Since September 12, 2024 (the date our shelf registration statement on Form S-3 went effective) through December 31, 2024, we sold 14,271,631 shares of our common stock under this program with gross proceeds of $24.3 million ($23.8 million, net of offering expenses). During the three months ended March 31, 2025, we sold 9,437,364 shares of our common stock under this program with gross proceeds of $18.7 million ($18.4 million, net of offering expenses).
Current wording
On September 3, 2024, in connection with the filing of a new shelf registration statement on Form S-3, we filed a prospectus related to our amended and restated sales agreement with Jefferies LLC (which amended and restated the prior sales agreement), pursuant to which we are able to offer and sell up to $75.0 million of our common stock at current market prices from time to time. Since September 12, 2024 (the date our shelf registration statement on Form S-3 went effective) through December 31, 2024, we sold 14,271,631 shares of our common stock under this program with gross proceeds of $24.3 million ($23.8 million, net of offering expenses). During the six months ended June 30, 2025, we sold 9,437,364 shares of our common stock under this program with gross proceeds of $18.7 million ($18.4 million, net of offering expenses).
Previous wording
Net product revenue was $55.8 million for the three months ended March 31, 2025, compared to $31.0 million for the three months ended March 31, 2024. The increase was primarily due to Vafseo's entry to the market in January 2025 and an increase in sales volumes of Auryxia.
Current wording
Net product revenue was $60.5 million for the three months ended June 30, 2025, compared to $41.2 million for the three months ended June 30, 2024. The increase was primarily due to Vafseo's entry to the market in January 2025 and an increase in sales volumes of Auryxia.
Previous wording
Auryxia lost exclusivity in the U.S. in March 2025, which may have a negative impact on future Auryxia revenue. We believe the dynamics of Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE scenarios. Additionally, in March 2025, our AG Partner began to sell and distribute an authorized generic version of Auryxia in the U.S., which may slightly offset a revenue decline following the LoE. However, our ability to continue to generate revenue from sales of Auryxia following LoE 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 and the pricing of generics and other products on the market that compete with Auryxia.
Current wording
Auryxia lost exclusivity in the U.S. in March 2025, which may have a negative impact on future Auryxia revenue. We believe the dynamics of Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE scenarios. Additionally, since March 2025, our AG Partner has been selling an authorized generic version of Auryxia in the U.S., which may slightly offset a revenue decline following the LoE. However, our ability to continue to generate revenue from sales of Auryxia following LoE 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 and the pricing of generics and other products on the market that compete with Auryxia.
Previous wording
License, Collaboration and Other Revenue—License, collaboration and other revenue was $1.5 million for the three months ended March 31, 2025, compared to $1.6 million for the three months ended March 31, 2024.
Current wording
License, Collaboration and Other Revenue—License, collaboration and other revenue was $2.0 million for the three months ended June 30, 2025, compared to $2.4 million for the three months ended June 30, 2024. The decrease was primarily due to revenue recognized in connection with our supply agreement with MTPC during the three months ended June 30, 2024.
Previous wording
Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $7.6 million for the three months ended March 31, 2025 compared to $2.6 million for the three months ended March 31, 2024. The increase was primarily due to a $3.7 million benefit that we recorded during the three months ended March 31, 2024 due to our ability to sell inventory previously written-down as excess inventory and lower Auryxia volume during the three months ended March 31, 2024.
Current wording
Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $9.9 million for the three months ended June 30, 2025 compared to $8.0 million for the three months ended June 30, 2024. The increase was primarily due to a $4.9 million benefit that we recorded during the three months ended June 30, 2024 due to our ability to sell inventory previously written-down as excess inventory and lower Auryxia volume during the three months ended June 30, 2024, which was partially offset by a charge of $2.1 million related to our firm purchase commitment liability during the three months ended June 30, 2024.
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, 2025, 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, 2025 was valued at cost, our cost of product and other revenue would have been $1.9 million. As of March 31, 2025, we had $27.6 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 $0.5 million for the three months ended June 30, 2025, 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, 2025 was valued at cost, our cost of product and other revenue would have been $1.1 million. As of June 30, 2025, we had $26.5 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 $9.8 million for the three months ended March 31, 2025, compared to $9.7 million for the three months ended March 31, 2024.
Current wording
R&D Expenses—R&D expenses were $11.0 million for the three months ended June 30, 2025, compared to $7.6 million for the three months ended June 30, 2024. The increase was primarily driven by increased clinical trial activities related to Vafseo as well as our other programs and higher headcount related costs.
Previous wording
License Expenses—License expenses related to royalties due to Panion relating to sales of Riona in Japan were $0.7 million for each of the three months ended March 31, 2025 and 2024.
Current wording
License Expenses—License expenses related to royalties due to Panion relating to sales of Riona in Japan were $0.9 million and $0.8 million for the three months ended June 30, 2025 and 2024, respectively.
Previous wording
Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $0.2 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively.
Current wording
Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $7.0 million and $2.3 million for the three months ended June 30, 2025 and 2024, respectively.
Previous wording
Restructuring Expenses—There were no restructuring expenses and $0.1 million of restructuring expenses for the three months ended March 31, 2025 and 2024, respectively.
Current wording
Restructuring Expenses—There were no restructuring expenses and $0.1 million of restructuring expenses for the six months ended June 30, 2025 and 2024, respectively.
Previous wording
Other Expense, Net—Other expense, net, was $7.6 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. The increase was primarily due to non-cash interest expense related to the settlement royalty liability in connection with the Vifor Termination Agreement. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, 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.
Current wording
Other Expense, Net—Other expense, net, was $14.4 million for the six months ended June 30, 2025, compared to $4.6 million for the six months ended June 30, 2024. The increase was primarily due to non-cash interest expense related to the settlement royalty liability in connection with the Vifor Termination Agreement, partially offset by 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, 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 our arrangements with CSL Vifor.
Previous wording
Loss on Extinguishment of Debt. During the three months ended March 31, 2024, we recorded $0.5 million loss on the extinguishment of debt in connection with the repayment of the Pharmakon Term Loans. We did not record any loss on the extinguishment of debt during the three months ended March 31, 2025.
Current wording
Loss on Extinguishment of Debt. During the six months ended June 30, 2024, we recorded a $0.5 million loss on the extinguishment of debt in connection with the repayment of the Pharmakon Term Loans. We did not record any loss on the extinguishment of debt during the six months ended June 30, 2025.
Previous wording
As of March 31, 2025, we had cash and cash equivalents of $113.4 million and restricted cash of $1.7 million.
Current wording
As of June 30, 2025, we had cash and cash equivalents of $137.3 million and restricted cash of $1.7 million.
Previous wording
We generated net operating income of $6.1 million and incurred net operating loss of $18.0 million during the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $1.7 billion.
Current wording
We generated net income of $0.2 million and $6.4 million during the three and six months ended June 30, 2025, respectively, and incurred net loss of $8.6 million and $26.6 million during the three and six months ended June 30, 2024, respectively. As of June 30, 2025 and December 31, 2024, 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. While we believe the dynamics of Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE scenarios, the impact of LoE 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 and the pricing of generics and other products on the market that compete with Auryxia. Additionally, in March 2025, our AG Partner began to sell and distribute an authorized generic version of Auryxia in the U.S., which may slightly offset the revenue decline following the LoE.
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. While we believe the dynamics of Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE scenarios, the impact of LoE 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 and the pricing of generics and other products on the market that compete with Auryxia. Additionally, since March 2025, our AG Partner has been selling an authorized generic version of Auryxia in the U.S., which may slightly offset the revenue decline following the LoE.
Previous wording
On the Closing Date, Kreos Capital VII Aggregator SCSp, an affiliate of Kreos, or the Warrant Holder, received a warrant to purchase 3,076,923 shares of our common stock, at an exercise price per share of $1.30, and upon the borrowing of Tranche C in February 2025, we issued additional warrants to purchase 1,153,846 shares of our common stock at an exercise price per share of $1.30. Each warrant is exercisable for eight years from the date of issuance.
Current wording
On the Closing Date, the Warrant Holder received a warrant to purchase 3,076,923 shares of our common stock, at an exercise price per share of $1.30, and upon the borrowing of Tranche C in February 2025, we issued additional warrants to purchase 1,153,846 shares of our common stock at an exercise price per share of $1.30. Each warrant is exercisable for eight years from the date of issuance.
Previous wording
Pursuant to the terms of the Vifor Termination Agreement, we will pay CSL Vifor decreasing quarterly tiered royalty payments ranging from a high single-digit percentage of our net sales of Vafseo up to $450.0 million to mid-single digit percentage of our net sales of Vafseo above $450.0 million, in each case, in the U.S. during a calendar year, or the Settlement Royalty Payments. The Settlement Royalty Payments commenced upon the first sale of Vafseo by us, our affiliates or third-party licensees to a third party for use in the U.S., and will continue until the later of the (i) expiration of the last-to-expire valid claim listed in the FDA OB that would be infringed by the making, using, selling or importing of Vafseo in the U.S. or (ii) the expiration of marketing or regulatory exclusivity for Vafseo in the U.S., or the Settlement Royalty Term. Beginning on July 1, 2027 and throughout the Settlement Royalty Term, we have the option to make a one-time payment to CSL Vifor, or the Royalty Buy-Down Option, upon which the Settlement Royalty Payments will be adjusted as of the date of exercise of the Royalty Buy-Down Option such that we will then only pay CSL Vifor quarterly royalty payments based on a mid-single digit percentage of our net sales of Vafseo up to $450.0 million in the U.S. during a calendar year in lieu of the above Settlement Royalty Payments. If we exercise the Royalty Buy-Down Option, the WCF Royalty Payments will continue as described below.
Current wording
Payments commenced upon the first sale of Vafseo by us, our affiliates or third-party licensees to a third party for use in the U.S., and will continue until the later of the (i) expiration of the last-to-expire valid claim listed in the FDA Orange Book that would be infringed by the making, using, selling or importing of Vafseo in the U.S. or (ii) the expiration of marketing or regulatory exclusivity for Vafseo in the U.S., or the Settlement Royalty Term. Beginning on July 1, 2027 and throughout the Settlement Royalty Term, we have the option to make a one-time payment to CSL Vifor, or the Royalty Buy-Down Option, upon which the Settlement Royalty Payments will be adjusted as of the date of exercise of the Royalty Buy-Down Option such that we will then only pay CSL Vifor quarterly royalty payments based on a mid-single digit percentage of our net sales of Vafseo up to $450.0 million in the U.S. during a calendar year in lieu of the above Settlement Royalty Payments. If we exercise the Royalty Buy-Down Option, the WCF Royalty Payments will continue as described below.
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, 2025 was 41.0% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss). The Company recognized interest expense of $5.4 million for the three months ended March 31, 2025. As of March 31, 2025, $10.6 million and $47.4 million of the settlement royalties liability 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, 2025 was 37.0% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss). The Company recognized interest expense related to the settlement royalties liability of $5.4 million and $10.8 million for the three and six months ended June 30, 2025, respectively. As of June 30, 2025, $14.7 million and $48.7 million of the settlement royalties liability 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 will commence 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, or the WCF Royalty Term. 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, 2025, $6.0 million and $34.4 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, 2025, $10.0 million and $30.6 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
In February 2021, we sold to HealthCare Royalty Partners IV L.P., or HCR, our right to receive royalties and sales milestones for Vafseo in Japan and certain other Asian countries, such countries collectively, the MTPC Territory, such payments collectively the Royalty Interest Payments, in each case, payable to us under the MTPC Agreement. The Royalty Interest Payments are subject to an annual maximum “cap” of $13.0 million, after which we will receive 85% of the Royalty Interest Payments for the remainder of that year. The Royalty Interest Payments are also subject to an aggregate maximum “cap” of $150.0 million, after which the Royalty Interest Payments will revert back to us.
Current wording
In February 2021, we sold to HealthCare Royalty Partners IV L.P., or HCR, our right to receive royalties and sales milestones for Vafseo in Japan and certain other Asian countries, such countries collectively, the MTPC Territory, such payments collectively the Royalty Interest Payments, in each case, payable to us under the Collaboration Agreement dated December 11, 2015, between us and MTPC, or the MTPC Agreement. The Royalty Interest Payments are subject to an annual maximum “cap” of $13.0 million, after which we will receive 85% of the Royalty Interest Payments for the remainder of that year. The Royalty Interest Payments are also subject to an aggregate maximum “cap” of $150.0 million, after which the Royalty Interest Payments will revert back to us.
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, 2025 was 0%. We retain the right to receive all potential future regulatory milestones for Vafseo under the MTPC Agreement. We recorded $0.4 million of non-cash royalty revenue during each of the three months ended March 31, 2025 and 2024. As of March 31, 2025, $2.0 million and $51.5 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, 2025 was 0%. We retain the right to receive all potential future regulatory milestones for Vafseo under the MTPC Agreement. We recorded non-cash royalty revenue of $0.5 million during each of the three months ended June 30, 2025 and 2024, and $0.9 million during each of the six months ended June 30, 2025 and 2024. As of June 30, 2025, $2.2 million and $51.1 million of the liability related to the sale of future royalties is classified as a current and non-current liability, respectively.
Previous wording
In June 2021, we entered into 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.
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
an upfront payment of $17.5 million that was paid in December 2022 and (ii) six quarterly payments of $2.5 million which commenced in April 2024. In addition, we and BioVectra have released one another from all existing and future claims and liabilities and agreed to return certain materials and documents.
Current wording
On December 22, 2022, we and BioVectra terminated any and all existing agreements for BioVectra to supply us Auryxia drug substance. Under the BioVectra Termination Agreement, we agreed to pay BioVectra a total of $32.5 million consisting of (i) an upfront payment of $17.5 million that was paid in December 2022 and (ii) six quarterly payments of $2.5 million which commenced in April 2024 and were completed in July 2025. In addition, we and BioVectra have released one another from all existing and future claims and liabilities and agreed to return certain materials and documents.
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 $42.2 million as of March 31, 2025. The scope of the services under these R&D contracts can be modified and the contracts 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 $57.7 million as of June 30, 2025. 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 $13.6 million for the three months ended March 31, 2025. Net cash used in operating activities for the three months ended March 31, 2025 consisted of a net income of $6.1 million reduced by net non-cash adjustments of $10.0 million, including a change in fair value of the warrant liability of $0.2 million, offset by a reduction of $29.7 million in working capital.
Current wording
Net cash provided by operating activities was $8.8 million for the six months ended June 30, 2025. Net cash provided by operating activities for the six months ended June 30, 2025 consisted of net income of $6.4 million as well as net non-cash adjustments of $27.0 million, including a change in fair value of the warrant liability of $6.8 million, offset by a reduction of $24.6 million in working capital.
Previous wording
Net cash used in operating activities was $19.4 million for the three months ended March 31, 2024. Net cash used in operating activities consisted of a net loss of $18.0 million and net non-cash adjustments of $13.7 million, including amortization of our intangible asset of $9.0 million, and a reduction of $15.1 million in working capital.
Current wording
Net cash used in operating activities was $29.5 million for the six months ended June 30, 2024. Net cash used in operating activities consisted of a net loss of $26.6 million and net non-cash adjustments of $25.9 million, including amortization of our intangible asset of $18.0 million, and a reduction of $28.8 million in working capital.
Previous wording
Net cash provided by investing activities for the three months ended March 31, 2025 of $0.2 million primarily consisted of proceeds from the sale of property and equipment. No net cash was used in investing activities for the three months ended March 31, 2024.
Current wording
Immaterial net cash was provided by investing activities for the six months ended June 30, 2025. Immaterial net cash was used in investing activities for the six months ended June 30, 2024.
Previous wording
Net cash provided by financing activities was $74.9 million for the three months ended March 31, 2025, which primarily consisted of proceeds of $10.0 million from the issuance of debt under the BlackRock Credit Agreement and net proceeds of $64.9 million from the sale of common stock from our March 2025 underwritten public offering and under our ATM facility.
Current wording
Net cash provided by financing activities was $76.7 million for the six months ended June 30, 2025, which primarily consisted of proceeds of $10.0 million from the issuance of debt under the BlackRock Credit Agreement and net proceeds of $66.4 million from the sale of common stock from our March 2025 underwritten public offering and under our ATM facility.
Previous wording
Net cash provided by financing activities was $18.5 million for the three months ended March 31, 2024, which primarily consisted of proceeds of $37.0 million from the issuance of debt under the BlackRock Credit Agreement and net proceeds of $18.7 million from the sale of common stock under our ATM Facility partially offset by principal payments of debt of $36.7 million primarily related to the Pharmakon Term Loans which were repaid in January 2024.
Current wording
Net cash provided by financing activities was $26.1 million for the six months ended June 30, 2024, which primarily consisted of proceeds of $45.0 million from the issuance of debt under the BlackRock Credit Agreement and net proceeds of $18.7 million from the sale of common stock under our ATM Facility, partially offset by principal payments of debt of $37.1 million primarily related to the Pharmakon Term Loans which were repaid in January 2024.
Previous wording
During the three months ended March 31, 2025, there were no material changes to our methodologies used for our critical accounting estimates as reported in our 2024 Form 10-K.
Current wording
During the six months ended June 30, 2025, there were no material changes to our methodologies used for our critical accounting estimates as reported in our 2024 Form 10-K.
Rearranged current paragraphs (14)
Current report — wording carried from elsewhere
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 lost exclusivity, or LoE. We believe the dynamics of
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 Partner.
Current report — wording carried from elsewhere
Net product revenue was $116.3 million for the six months ended June 30, 2025, compared to $72.2 million for the six months ended June 30, 2024. The increase was primarily due to Vafseo's entry to the market in January 2025 and an increase in sales volumes of Auryxia.
Current report — wording carried from elsewhere
Auryxia lost exclusivity in the U.S. in March 2025, which may have a negative impact on future Auryxia revenue. We believe the dynamics of Auryxia reimbursement being included in the ESRD bundle could result in a slower revenue decline after the LoE date than in other LoE scenarios. Additionally, since March 2025, our AG Partner has been selling an authorized generic version of Auryxia in the U.S., which may slightly offset a revenue decline following the LoE. However, our ability to continue to generate revenue from sales of Auryxia following LoE 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 and the pricing of generics and other products on the market that compete with Auryxia.
Current report — wording carried from elsewhere
The following table summarizes our product revenue by product for the six months ended June 30, 2025 and 2024 (in thousands):
Current report — wording carried from elsewhere
(1) Vafseo entered the U.S. market in January 2025.
Current report — wording carried from elsewhere
(2) Includes the authorized generic version of Auryxia sold and distributed by our AG Partner during the six months ended June 30, 2025.
Current report — wording carried from elsewhere
Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $17.5 million for the six months ended June 30, 2025 compared to $10.6 million for the six months ended June 30, 2024. The increase was primarily due to a $8.6 million benefit that we recorded during the six months ended June 30, 2024 due to our ability to sell inventory previously written-down as excess inventory and lower Auryxia volume during the six months ended June 30, 2024, which was partially offset by a charge of $2.1 million related to our firm purchase commitment liability during the six months ended June 30, 2024.
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 $1.9 million for the six months ended June 30, 2025, 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, 2025 was valued at cost, our cost of product and other revenue would have been $3.0 million. As of June 30, 2025, we had $26.5 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
Cost of Goods Sold—Amortization of Intangible Asset—Amortization of intangible asset related to the acquired developed product rights for Auryxia, and was amortized using a straight-line method over its estimated useful life of approximately six years. Our intangible asset was fully amortized as of December 31, 2024. We recorded no amortization expense and $18.0 million in amortization expense for the six months ended June 30, 2025 and 2024, respectively, related to the developed product rights for Auryxia.
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, 2025 and 2024 (in thousands):
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 as well as Vafseo.
Current report — wording carried from elsewhere
License Expenses—License expenses related to royalties due to Panion relating to sales of Riona in Japan were $1.6 million and $1.5 million for the six months ended June 30, 2025 and 2024, respectively.
Current report — wording carried from elsewhere
On July 10, 2024, we and CSL Vifor entered into the Vifor Termination Agreement. Pursuant to the terms of the Vifor Termination Agreement, we will pay CSL Vifor decreasing quarterly tiered royalty payments ranging from a high single-digit percentage of our net sales of Vafseo up to $450.0 million to a mid-single digit percentage of our net sales of Vafseo above $450.0 million, in each case, in the U.S. during a calendar year, or the Settlement Royalty Payments. The Settlement Royalty
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
On February 3, 2025, in connection with the drawdown of the Extended Tranche C Loan, in accordance with the warrant agreement, dated as of January 29, 2024, between the Company and Kreos Capital VII Aggregator SCSp, or the Warrant
Previous report — wording carried elsewhere
On December 22, 2022, we and BioVectra terminated any and all existing agreements for BioVectra to supply us Auryxia drug substance. Under the BioVectra Termination Agreement, we agreed to pay BioVectra a total of $32.5 million consisting of (i)