Akebia Therapeutics, Inc.

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 erythropoiesis stimulating agent, or ESA, pricing and Vafseo is the only oral HIF-based treatment available in the U.S.

Current wording

Vafseo 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. 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

In the European Union, or EU, the United Kingdom, or UK, Switzerland and Australia, Vafseo is approved for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. Our partner MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, has an exclusive license to develop and commercialize Vafseo for the treatment of anemia in patients with CKD in defined territories and launched Vafseo in Germany, Austria, Switzerland, the Netherlands and certain other countries in Europe in 2024.

Current wording

In the European Union, or EU, the United Kingdom, or UK, Switzerland and Australia, Vafseo is approved for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. Our partner MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, has an exclusive license to develop and commercialize Vafseo for the treatment of anemia in patients with CKD in defined territories and launched Vafseo in Germany, Austria, Switzerland, the Netherlands and certain other countries in Europe.

Previous 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.

Current wording

Today, we market Auryxia in the U.S. Auryxia became part of our portfolio in 2018 and has historically contributed meaningful revenue to the business. In March 2025, Auryxia 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.

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 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.

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. In November 2025, the Medicines and Healthcare Products Regulatory Agency, or MHRA, granted Averoa's UK marketing authorization. However, Averoa has not yet obtained pricing authorization nor commenced sales of ferric citrate in Europe or UK.

Previous wording

The Term Loan Facility provided us access to three tranches: (i) an initial tranche of $37.0 million, which was funded on January 29, 2024, (ii) an additional tranche of $8.0 million, which was funded on April 19, 2024, and (iii) a final tranche of $10.0 million, which was available in a single draw through an expiry date of December 31, 2024, or the Prior Tranche C Loan. As a result of the Second Amendment, the Prior Tranche C Loan expiry date was extended until February 3, 2025, or the Extended Tranche C Loan. The terms of the Extended Tranche C Loan are substantially similar to the terms of the Prior Tranche C Loan, however, interest will accrue on the Extended Tranche C Loan as if it was advanced on December 31, 2024.

Current wording

The Term Loan Facility provided us access to three tranches: (i) an initial tranche of $37.0 million, which was funded on January 29, 2024, (ii) an additional tranche of $8.0 million, which was funded on April 19, 2024, and (iii) a final tranche of $10.0 million, which was available in a single draw through an expiry date of December 31, 2024, or the Prior Tranche C Loan. As a result of the Second Amendment, the Prior Tranche C Loan expiry date was extended until February 3, 2025, or the Extended Tranche C Loan. The terms of the Extended Tranche C Loan are substantially similar to the terms of the Prior Tranche C Loan, however, interest accrued on the Extended Tranche C Loan as if it was advanced on December 31, 2024.

Previous wording

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 wording

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.

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 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).

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. From 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 nine months ended September 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 $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.

Current wording

Net product revenue was $56.8 million for the three months ended September 30, 2025, compared to $35.6 million for the three months ended September 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

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 wording

License, Collaboration and Other Revenue—License, collaboration and other revenue was $2.0 million for the three months ended September 30, 2025, compared to $1.8 million for the three months ended September 30, 2024.

Previous 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.

Current wording

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $9.4 million for the three months ended September 30, 2025 compared to $5.2 million for the three months ended September 30, 2024. The increase was primarily due to higher Auryxia volume during the three months ended September 30, 2025. In addition, cost of product and other revenue for the three months ended September 30, 2024 was offset by a $3.7 million benefit that we recorded due to our ability to sell inventory previously written-down as excess inventory during the three months ended September 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 $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.

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 September 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 September 30, 2025 was valued at cost, our cost of product and other revenue would have been $1.6 million. As of September 30, 2025, we had $25.4 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

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 $9.0 million in amortization expense for the three months ended June 30, 2025 and 2024, respectively, related to the developed product rights for Auryxia.

Current wording

Cost of Goods Sold—Amortization of Intangible Asset—Amortization of intangible asset related to the acquired developed product rights for Auryxia 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 $9.0 million in amortization expense for the three months ended September 30, 2025 and 2024, respectively, related to the developed product rights for Auryxia.

Previous 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.

Current wording

R&D Expenses—R&D expenses were $14.9 million for the three months ended September 30, 2025, compared to $8.5 million for the three months ended September 30, 2024. The increase was primarily driven by increased clinical trial activities related to Vafseo and higher headcount related costs.

Previous wording

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 wording

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $29.1 million for the three months ended September 30, 2025, compared to $26.5 million for the three months ended September 30, 2024. The increase was largely due to higher marketing costs in connection with the Vafseo U.S. launch and increased headcount related costs during the three months ended September 30, 2025.

Previous 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.

Current wording

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $1.5 million and $0.9 million for the three months ended September 30, 2025 and 2024, respectively.

Previous wording

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 wording

Net product revenue was $173.0 million for the nine months ended September 30, 2025, compared to $107.8 million for the nine months ended September 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

The following table summarizes our product revenue by product for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our product revenue by product for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

(2) Includes the authorized generic version of Auryxia sold and distributed by our AG Partner during the six months ended June 30, 2025.

Current wording

(2) Includes the authorized generic version of Auryxia sold and distributed by our AG Partner during the nine months ended September 30, 2025.

Previous 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.

Current wording

License, Collaboration and Other Revenue—License, collaboration and other revenue was $5.5 million for the nine months ended September 30, 2025, compared to $5.9 million for the nine months ended September 30, 2024. The decrease was primarily due to revenue recognized in connection with our supply agreement with MTPC during the nine months ended September 30, 2024.

Previous wording

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 wording

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $26.9 million for the nine months ended September 30, 2025 compared to $15.8 million for the nine months ended September 30, 2024. The increase was primarily due to higher Auryxia volume during the nine months ended September 30, 2025. In addition, cost of product and other revenue for the nine months ended September 30, 2024 was offset by a $12.3 million benefit that we recorded due to our ability to sell inventory previously written-down as excess inventory during the nine months ended September 30, 2024. We also recorded a charge of $2.1 million related to our firm purchase commitment liability during the nine months ended September 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 $1.9 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 wording

We began capitalizing our Vafseo costs in March 2024, in connection with the FDA's approval of Vafseo for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Prior to the capitalization of Vafseo inventory costs, such costs were recorded as research and development expenses in the period incurred. Cost of product and other revenue for Vafseo was $2.4 million for the nine months ended September 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 nine months ended September 30, 2025 was valued at cost, our cost of product and other revenue would have been $4.6 million. As of September 30, 2025, we had $25.4 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

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 wording

Cost of Goods Sold—Amortization of Intangible Asset—Amortization of intangible asset related to the acquired developed product rights for Auryxia 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 $27.0 million in amortization expense for the nine months ended September 30, 2025 and 2024, respectively, related to the developed product rights for Auryxia.

Previous wording

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 wording

R&D Expenses—R&D expenses were $35.7 million for the nine months ended September 30, 2025, compared to $25.9 million for the nine months ended September 30, 2024. The increase was primarily due to clinical trial activities related to Vafseo and higher headcount related costs.

Previous wording

The following table summarizes our external research and development expenses by program, as well as costs not allocated to programs, for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our external research and development expenses by program, as well as costs not allocated to programs, for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

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 wording

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $81.4 million for the nine months ended September 30, 2025, compared to $78.9 million for the nine months ended September 30, 2024. The increase was largely due to higher marketing costs in connection with the Vafseo U.S. launch and increased headcount related costs during the nine months ended September 30, 2025.

Previous wording

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 wording

License Expenses—License expenses related to royalties due to Panion relating to sales of Riona in Japan were $2.5 million and $2.2 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous 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.

Current wording

Restructuring Expenses—There were no restructuring expenses and $0.1 million of restructuring expenses for the nine months ended September 30, 2025 and 2024, respectively.

Previous 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.

Current wording

Other Expense, Net—Other expense, net, was $19.2 million for the nine months ended September 30, 2025, compared to $11.3 million for the nine months ended September 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 which we entered into in July 2024, 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

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 wording

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $5.4 million and $1.3 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous 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.

Current wording

Loss on Extinguishment of Debt—During the nine months ended September 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 nine months ended September 30, 2025.

Previous wording

As of June 30, 2025, we had cash and cash equivalents of $137.3 million and restricted cash of $1.7 million.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $166.4 million and restricted cash of $1.7 million.

Previous 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.

Current wording

We generated net income of $0.5 million and $6.9 million during the three and nine months ended September 30, 2025, respectively, and incurred net loss of $20.0 million and $46.6 million during the three and nine months ended September 30, 2024, respectively. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $1.7 billion.

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 the foreseeable future, including to commercialize Vafseo and Auryxia, pursue label expansion for Vafseo, and advance our other existing programs. However, if our operating performance deteriorates significantly from the levels expected in our long-term operating plan, 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

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 the foreseeable future, 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.

Previous wording

All obligations under the Term Loan Facility are secured by substantially all of our existing and after-acquired assets. The BlackRock Credit Agreement requires us to either (i) maintain cash and cash equivalents, measured as of the last day of each fiscal month, greater than or equal to $15.0 million or (ii) earn consolidated revenue, measured as of the last day of each fiscal month for the trailing twelve-month period, of $150.0 million. The BlackRock Credit Agreement contains certain representations and warranties, affirmative and negative covenants that limit our ability to engage in specified types of transactions and other provisions typical within a credit agreement. If an event of default occurs and is continuing under the BlackRock Credit Agreement, BlackRock is entitled to take enforcement action, including acceleration of amounts due which could limit our ability to make certain payments under the Vifor Termination Agreement. If we prepay the Term Loans prior to the BlackRock Maturity Date, we will be required to pay a prepayment fee ranging from 1.0% to 4.0% of the amount prepaid.

Current wording

All obligations under the Term Loan Facility are secured by substantially all of our existing and after-acquired assets. The BlackRock Credit Agreement requires us to either (i) maintain cash and cash equivalents, measured as of the last day of each fiscal month, greater than or equal to $15.0 million or (ii) earn consolidated revenue, measured as of the last day of each fiscal month for the trailing twelve-month period, of $150.0 million. The BlackRock Credit Agreement contains certain representations and warranties, affirmative and negative covenants that limit our ability to engage in specified types of transactions and other provisions typical within a credit agreement. If an event of default occurs and is continuing under the BlackRock Credit Agreement, BlackRock is entitled to take enforcement action, including acceleration of amounts due which could limit our ability to make certain payments under the Vifor Termination Agreement. If we prepay the Term Loans prior to the BlackRock Maturity Date, we will be required to pay a prepayment fee ranging from 1.0% to 4.0% of the amount prepaid. If prepayment is made during the first year, we are required to pay the amount of otherwise due interest payments for the twelve-month period following pre-payment.

Previous wording

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 wording

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.

Previous 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.

Current wording

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 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 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.

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 September 30, 2025 was 24.6% 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 $3.9 million and $14.7 million for the three and nine months ended September 30, 2025, respectively. As of September 30, 2025, $14.3 million and $53.0 million of the settlement royalties liability is classified as a current and non-current liability, respectively.

Previous wording

The Working Capital Fund is considered a debt arrangement with zero coupon interest and we impute interest on the Working Capital Fund liability at a rate of 15.0% per annum. As of June 30, 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.

Current wording

The Working Capital Fund is considered a debt arrangement with zero coupon interest and we impute interest on the Working Capital Fund liability at a rate of 15.0% per annum. As of September 30, 2025, $13.0 million and $27.7 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 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.

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

Previous wording

We received $44.8 million from HCR, net of certain transaction expenses, which we recorded as a liability at the transaction date. We amortize the liability related to the sale of future royalties using the effective interest method over the life of the arrangement. The annual effective interest rate as of June 30, 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.

Current wording

We received $44.8 million from HCR, net of certain transaction expenses, which we recorded as a liability at the transaction date. We amortize the liability related to the sale of future royalties using the effective interest method over the life of the arrangement. The annual effective interest rate as of September 30, 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 September 30, 2025 and 2024, and $1.3 million and $1.4 million during the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, $2.1 million and $50.6 million of the liability related to the sale of future royalties is classified as a current and non-current liability, respectively.