What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-07 compared with 2025-11-10 · 195 added, 279 removed, 197 unchanged (71% of the section changed)

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The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the United States, or U.S.

, Securities and Exchange Commission, or the SEC , on March 13, 2025, or the 2024 Form 10-K .

, Securities and Exchange Commission, or the SEC , on February 26, 2026, or the 2025 Form 10-K .

In addition to historical information, the following discussion and analysis contains forward-looking statements that reflect our plans, estimates, beliefs and explanations that involve significant risks and uncertainties.

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We are a fully integrated biopharmaceutical company with two commercial products for patients impacted by kidney disease.

We have built a business focused on developing and commercializing innovative therapeutics that we believe serves as a foundation for future growth.

Our team has significant expertise in hypoxia-inducible factor, or HIF , science having developed and commercialized Vafseo® (vadadustat), an oral HIF factor prolyl hydroxylase, or HIF-PH , inhibitor and have selected two additional HIF-based molecules for preclinical development.

We have established the company as a leader in the kidney community, and we believe our cross-organizational expertise in renal disease positions the company for success.

We have built a business focused on developing and commercializing innovative therapeutics that we believe serve as a foundation for future growth, including by contributing net product revenue to support the development and advancement of our robust pipeline of mid-stage programs targeting rare kidney diseases and early-stage programs targeting kidney disease and non-kidney focused indications.

We have established the Company as a leader in the kidney community and believe our cross-organizational expertise in kidney disease positions us for success.

Chronic kidney disease, or CKD , is a condition in which the kidneys are progressively damaged to the point that they cannot properly filter the blood circulating in the body.

This damage causes waste products to build up in the patient’s blood, leading to other health problems, including anemia, cardiovascular disease and bone disease.

CKD significantly impacts the U.S.

healthcare system, potentially affecting approximately 37 million patients and costing Medicare nearly $125 billion annually for treating Medicare beneficiaries with CKD or end-stage renal disease, or ESRD , according to the Centers for Disease Control and Prevention.

CKD significantly impacts the United States, or U.S.

, healthcare system, potentially affecting approximately 35.5 million patients.

In 2022, in the U.S.

treating Medicare beneficiaries with CKD cost an estimated $95.7 billion, and treating people on dialysis cost an estimated $45.3 billion.

Our two commercial products address certain complications of kidney disease.

Our current portfolio includes:

Vafseo is an orally administered medicine that was approved by the U.S.

Our current product portfolio includes:

Vafseo® (vadadustat) is an orally administered medicine that was approved by the U.S.

Food and Drug Administration, or the FDA , in March 2024 for the treatment of anemia due to CKD in adult patients on dialysis for at least three months.

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.

We recently completed a Type C meeting with the FDA and, while we have not yet received final minutes from the meeting, based on the FDA feedback, we have not come to alignment regarding a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage CKD not on dialysis.

As a result, we do not plan to initiate VALOR and therefore do not expect to pursue a broad label for Vafseo for CKD non-dialysis dependent patients.

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 Japan, Vafseo is approved as a treatment for anemia due to CKD in both dialysis dependent and non-dialysis dependent patients and is marketed and sold by our collaborator Mitsubishi Tanabe Pharma Corporation, or MTPC .

In Taiwan, Vafseo is approved for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis and launched in October 2024 by Tai Tien Pharmaceutical Company, an affiliate of MTPC.

In Korea, Vafseo is approved as an anemia treatment for patients with CKD on hemodialysis.

market opportunity for the treatment of anemia due to CKD in patients with dialysis is approximately $1 billion based on current erythropoiesis stimulating agent, or ESA , pricing.

Vafseo is the only oral hypoxia inducible factor, or HIF , based treatment available in the U.S.

Vafseo entered the market in January 2025, at which time we had commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S.

Throughout 2025, we worked closely with dialysis organizations as their medical teams developed, implemented and operationalized protocols to enable prescribers to write Vafseo prescriptions for clinically appropriate patients.

Currently, approximately 290,000 dialysis patients in the U.S.

have prescribing access to Vafseo.

Vafseo is approved for use in adults in 37 countries and is marketed in certain countries outside the U.S.

by our partners.

Auryxia® (ferric citrate) is an orally administered medicine approved and marketed in the U.S.

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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

In March 2025, Auryxia reached loss of exclusivity, or LoE .

On March 11, 2026, Teva Pharmaceuticals Ltd., or Teva , received approval for its Abbreviated New Drug Application, or ANDA , for a generic version of Auryxia, which has subsequently entered the market.

Ferric citrate is approved for use and marketed in certain countries outside the U.S.

by our partners.

Our development pipeline includes:

Our mid-stage rare kidney disease pipeline assets , praliciguat and AKB-097, are being evaluated to target areas of unmet need.

In June 2021, we licensed praliciguat from Cyclerion Therapeutics, Inc., or Cyclerion , via an exclusive global license, which includes certain intellectual property rights to research, develop and commercialize the asset.

Praliciguat is an oral, once-daily soluble guanylate cyclase, or sGC , stimulator.

We are evaluating praliciguat for the treatment of biopsy-confirmed focal segmental glomerulosclerosis, or FSGS , a rare kidney disease, in a Phase 2 clinical trial.

The first patient was dosed in this trial in December 2025.

We also plan to assess the use of praliciguat in other rare podocytopathies in the future.

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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.

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.

Our HIF-based product candidates and other pipeline assets are being evaluated to target areas of unmet needs.

The discovery of HIF laid the foundation to explore the central role of oxygen sensing in many diseases.

As we have seen through the development of Vafseo as a treatment for anemia due to CKD, when stabilized, HIF triggers wide-ranging adaptive, protective responses during hypoxic or ischemic conditions.

We have selected two additional HIF molecules for preclinical development:

AKB-9090, potentially for cardiac surgery-related acute kidney injury, or CS-AKI , or acute respiratory distress syndrome, or ARDS , and AKB-10108 for retinopathy of prematurity, or ROP , in neonates.

In June 2021, we acquired from Cyclerion Therapeutics, Inc., or Cyclerion , an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral soluble guanylate cyclase, or sGC , stimulator.

We believe there is potential to explore the use of praliciguat for indications within kidney disease.

In November 2025, we entered into an asset purchase agreement with Q32 Bio Inc.

and Q32 Bio Operations Inc., together Q32 , pursuant to which we purchased and assumed substantially all assets and liabilities of Q32 and its affiliates related to the research, development, manufacture and commercialization of Q32’s clinical-stage development candidate known as ADX-097 (now referred to as AKB-097, generic name ebribafusp), an anti-C3d-Factor H fusion protein complement inhibitor.

AKB-097 is a potential next-generation complement inhibitor, and we believe AKB-097 has applicability across a wide range of complement-mediated rare kidney diseases.

AKB-097 is intended to provide targeted regulation of complement activation at sites of tissue injury while limiting systemic complement inhibition.

We expect to initiate a Phase 2 basket study in the second half of 2026 to evaluate AKB-097 for the following indications:

IgA Nephropathy, or IgAN ;

C3 Glomerulopathy, or C3G;

and Lupus Nephritis, or LN .

Our early-stage pipeline assets include AKB-9090 and AKB-10108, which are HIF molecules.

We plan to initially evaluate AKB-9090 for the treatment of cardiac surgery-related acute kidney injury, or CS-AKI .

The first patient was dosed in a Phase 1 study in healthy volunteers in April 2026.

We may also study AKB-9090 in acute respiratory distress syndrome, or ARDS , as well as other acute treatment indications.

AKB-10108 will potentially be evaluated for retinopathy of prematurity, or ROP , in neonates, and other indications, and is currently in preclinical development.

We continue to explore additional commercial and development opportunities to expand our pipeline and portfolio of novel therapeutics through both internal research and external innovation to leverage our fully integrated team.

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Product Revenue

We generate product revenue from commercial sales of Auryxia and Vafseo to a limited number of customers, including dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our authorized generic distribution partner, Mylan Therapeutics, Inc., or AG Partner .

Our net product revenue includes many variables, including judgments and estimates of discounts, rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year.

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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.

Following LoE, since March 2025, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S.

On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia, which has subsequently entered the market.

We expect Teva's entry into the market, and the entry of any additional generic versions of Auryxia that may be approved in addition to our AG Distributor, will adversely impact our revenue.

However, the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

License, Collaboration and Other Revenue

License, collaboration and other revenue includes revenue earned under our agreements with our partners, including license fees, royalty payments and revenue from product we supply.

We expect to continue to generate revenue from our collaboration, license and supply agreements with Medice, MTPC, JT and Torii and any other collaborations into which we have entered or may enter.

Cost of Goods Sold

Cost of goods sold, or COGS - Cost of product and other revenue includes costs closely correlated or directly related to the costs to manufacture commercial drug substance and drug product, including at our contract manufacturing organizations, or CMOs , as well as indirect costs.

Direct and indirect costs include fees for packaging, shipping, insurance and quality assurance, idle capacity charges, changes in reserves for excess inventory, write-offs for inventory that fails to meet specifications or is otherwise no longer suitable for commercial sale, including scrap, changes in our firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S.

We expect to continue to generate revenue from our collaboration, license and supply agreements with Medice, Tanabe Pharma Corporation, or TPC , JT and Torii and any other collaborations into which we have entered or may enter.

Cost of Product and Other Revenue

Cost of product and other revenue includes costs closely correlated or directly related to the costs to manufacture commercial drug substance and drug product, including at our contract manufacturing organizations, or CMOs , as well as indirect costs.

Direct and indirect costs include fees for packaging, shipping, insurance and quality assurance, idle capacity charges, changes in reserves for excess inventory, write-offs for inventory that fails to meet specifications or is otherwise no longer suitable for commercial sale, including scrap, changes in a firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S.

and Japan product sales recognized during the period.

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Cost of product and other revenue also includes costs to manufacture drug product provided to MTPC and Medice for commercial sales of Vafseo in Japan and in the EEA, the UK, Switzerland and Australia, or collectively the Medice Territory , respectively, as well as to our AG Partner.

Cost of product and other revenue also includes costs to manufacture drug product provided to TPC and Medice for commercial sales of Vafseo in Japan and in the EEA, the UK, Switzerland and Australia, or collectively the Medice Territory , respectively, as well as to our AG Distributor.

In addition, cost of product and other revenue includes personnel-related costs, including salaries and bonuses, employee benefits and stock-based compensation attributable to employees in particular functions and associated directly with the manufacturing of our commercial products.

Cost of product and other revenue for a newly launched product does not include the full cost of manufacturing until the initial pre-launch inventory is depleted and additional inventory is manufactured and sold.

Until we received regulatory approval for Vafseo in the U.S., we recorded costs incurred to manufacture the U.S.

Until we received regulatory

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approval for Vafseo in the U.S., we recorded costs incurred to manufacture the U.S.

pre-launch inventory, such as raw materials, drug substance and drug product conversion costs as research and development, or R&D , expense.

Cost of goods sold - Amortization of intangible asset - In addition, COGS included the amortization of development product rights for Auryxia through the end of 2024.

Research and Development Expenses

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• facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies associated with our laboratory space as well as our R&D team;

• acquired in process research and development costs associated with the acquisition of Q32's clinical stage development asset now referred to as AKB-097;

• costs associated with discovery and development for preclinical, clinical and regulatory activities.

• costs associated with the pre-launch inventory build for Vafseo in the U.S.

prior to the FDA approval in March 2024.

R&D costs are expensed as incurred.

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We cannot determine with certainty the duration and completion costs of our R&D projects, the costs of related clinical development, or if, when, or to what extent we will generate revenue from the commercialization or sale of any of our product candidates.

From inception through September 30, 2025, we have incurred $1.7 billion in R&D expenses.

We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired.

From inception through March 31, 2026, we have incurred $1.8 billion in R&D expenses.

We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Auryxia, Vafseo, praliciguat, AKB-097, AKB-9090 and any other product or product candidate, including those that may be in-licensed or acquired.

A significant portion of our R&D costs have been external costs, which we track on a program-by-program basis as well as costs related to possible new manufacturing processes and methods associated with our commercial products.

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Selling, General and Administrative Expenses

Selling, general and administrative, or SG&A , expenses consist primarily of compensation for personnel, including stock-based compensation related to commercial, marketing, executive, finance and accounting, information technology, corporate and

Other SG&A expenses include costs for marketing initiatives for our commercial products, market research and analysis on our commercial products and potential product candidates, conferences and trade shows, travel expenses, professional services fees (including legal, patent, accounting, audit, tax, and consulting fees), insurance costs, general corporate expenses and allocated facilities-related expenses, including rent and maintenance of facilities.

License Expense

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business development and human resource functions.

License Expenses

License expenses relate to royalties due to Panion & BF Biotech, Inc., or Panion , for sales of Auryxia in the U.S.

License expense relates to royalties due to Panion & BF Biotech, Inc., or Panion , for sales of Auryxia in the U.S.

and Riona in Japan.

Other Income (Expense), Net

Other income (expense), net consists primarily of interest income on our interest-bearing accounts, interest expense related to our term loans, accretion of the debt discount on our term loans as well as amortization of the discount on the liability related to the termination fees associated with the termination agreement with BioVectra Inc., or BioVectra , entered into in December 2022, or the BioVectra Termination Agreement .

See Note 10, Commitments and Contingencies, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the BioVectra Termination Agreement.

Other income (expense) also includes non-cash interest on our liability related to settlement royalties and the amortization of the discount and deferred gain related to our Working Capital Fund (as defined below) liability to Vifor (International) Ltd.

Other income (expense), net consists primarily of interest income on our interest-bearing accounts, interest expense related to our term loans and accretion of the debt discount on our term loans.

Other income (expense), net, also includes non-cash interest on our liability related to settlement royalties and the amortization of the discount and deferred gain related to our Working Capital Fund (as defined below) liability to Vifor (International) Ltd.

(now a part of CSL Limited), or CSL Vifor .

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

See Note 3, Fair Value of Financial Instruments , and Note 7, Indebtedness , in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the warrant liability.

See Note 3, Fair Value Measurements , and Note 7, Indebtedness , in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the warrant liability.

Recent Events

Public Offering of Common Stock

On March 19, 2025, we entered into an underwriting agreement, or the Underwriting Agreement , with Leerink Partners LLC and Piper Sandler & Co., as representatives of the several underwriters named therein, collectively, the Underwriters , relating to an underwritten public offering, or the Offering , of 25,000,000 shares, or the Shares , of our common stock.

The offering price was $2.00 per share, and the Underwriters agreed to purchase the Shares from us pursuant to the Underwriting Agreement at a price of $1.88 per share.

Under the terms of the Underwriting Agreement, we granted the Underwriters a 30-day option to purchase up to 3,750,000 additional shares of common stock, or the Additional Shares , at the public offering price per share, and the Underwriters partially exercised their option and purchased 850,000 Additional Shares on April 22, 2025.

Net proceeds from the Offering of the Shares were $46.5 million, after deducting underwriting discounts and commissions and estimated offering expenses and net proceeds from the Offering of the Additional Shares were $1.6 million, after deducting underwriting discounts and commissions and estimated offering expenses.

Borrowing Under BlackRock Term Loans

On February 3, 2025, we and Kreos , which are funds and accounts managed by BlackRock Inc., collectively, BlackRock , entered into the Second Amendment to the Agreement for the Provision of a Loan Facility, or the Second Amendment , which amended certain provisions of the Agreement for the Provision of a Loan Facility, dated January 29, 2024, or the BlackRock Credit Agreement .

The BlackRock Credit Agreement provides for a senior secured term loan facility in the aggregate principal amount of up to $55.0 million, subject to certain customary conditions, or the Term Loan Facility .

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.

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On February 3, 2025, we received $9.3 million on the Extended Tranche C Loan, after deducting debt issuance costs, interest, fees and expenses.

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.

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

At-the-Market (ATM) Offering

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).

Cambridge Lease Extension - Lab Space

On April 9, 2026, the Company extended the term of the Cambridge Lease with respect to the laboratory space from September 11, 2026 to October 31, 2026.

See Note 7, Subsequent Events , for further information

Initiation of Phase 1 Trial in CS-AKI

In April 2026, we dosed our first patient in a Phase 1 clinical trial of AKB-9090 for the treatment of CS-AKI.

Initiation of Phase 2 Trial in FSGS

In December 2025, we dosed our first patient in a Phase 2 clinical trial of praliciguat for the treatment of biopsy-confirmed FSGS.

As a result, in February 2026, pursuant to the terms of a License Agreement, as amended, dated June 3, 2021, by and between us and Cyclerion, or the Cyclerion Agreement , upon such dosing, we paid a $1.0 million regulatory milestone payment to Cyclerion.

See Note 10, Commitments and Contingencies , in the accompanying notes to the consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the Cyclerion Agreement.

Waltham Lease

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

We intend to relocate our corporate headquarters to Waltham in September 2026.

See Note 9, Leases , in the accompanying notes to the consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the Waltham Lease.

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Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

Three Months Ended September 30, Change

Comparison of the Three Months Ended March 31, 2026 and 2025

Three Months Ended March 31, Change

(dollars in thousands) 2026 2025 $ %

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Cost of product and other revenue 12,290 7,625 4,665 61 %

Amortization of intangible asset — 9,011 (9,011) (100) %

Total cost of goods sold 12,290 7,625 4,665 61 %

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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.

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.

We distribute Auryxia and Vafseo principally through a limited number of dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our AG Distributor for Auryxia.

Net product revenue was $52.0 million for the three months ended March 31, 2026, compared to $55.8 million for the three months ended March 31, 2025.

The decrease was primarily due to lower Auryxia revenues, which were partially offset by higher Vafseo revenues.

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.

in March 2025, which we expect to have a negative impact on future Auryxia revenue.

Following LoE, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S.

On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia, which has subsequently entered the market.

We expect Teva's entry into the market, and the entry of any additional generic versions of Auryxia that may be approved in addition to our AG Distributor, will adversely impact our revenue.

However, the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics that enter the market, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

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

Three Months Ended September 30,

42,467 35,592

Total product revenues

The following table summarizes our product revenue by product for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

$ 15,802 $ 12,034

(1) Vafseo entered the U.S.

market in January 2025.

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

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.

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.

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.

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.

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.

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

Three Months Ended September 30,

Vafseo clinical trial and other external costs $ 7,154 $ 3,046

External costs for other programs, including feasibility and new processes and methods associated with commercial product 1,386 1,462

Total external R&D expenses 8,540 4,508

Internal personnel, consulting, facilities and other 6,404 3,979

Total R&D expenses $ 14,944 $ 8,487

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| Form 10-Q | Page 36

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.

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.

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 September 30, 2025 and 2024, respectively.

Other Expense, Net— Other expense, net, was $4.8 million for the three months ended September 30, 2025, compared to $6.7 million for the three months ended September 30, 2024.

The decrease was primarily due to increased interest income related to our money market funds which offset interest expense during the three months ended September 30, 2025.

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.

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

There was no income tax expense for the three months ended September 30, 2024.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 37

Comparison of the Nine Months Ended September 30, 2025 and 2024

Nine Months Ended September 30, Change

(dollars in thousands) 2025 2024 $ %

Product revenue, net $ 173,041 $ 107,810 $ 65,231 61 %

License, collaboration and other revenue 5,533 5,873 (340) (6) %

Total revenues 178,574 113,683 64,891 57 %

Cost of goods sold

Cost of product and other revenue 26,927 15,780 11,147 71 %

Amortization of intangible asset — 27,032 (27,032) (100) %

Total cost of goods sold 26,927 42,812 (15,885) (37) %

Operating expenses

Research and development 35,711 25,866 9,845 38 %

Selling, general and administrative 81,391 78,870 2,521 3 %

License 2,493 2,242 251 11 %

Restructuring — 58 (58) (100) %

Total operating expenses 119,595 107,036 12,559 12 %

Operating income (loss) 32,052 (36,165) 68,217 (189) %

Other expense, net (19,177) (11,269) (7,908) 70 %

Change in fair value of warrant liability (5,361) 1,345 (6,706) (499) %

Loss on extinguishment of debt — (517) 517 (100) %

Income (loss) before income taxes 7,514 (46,606) 54,120 (116) %

Income tax expense (615) — (615) *

Net income (loss) $ 6,899 $ (46,606) $ 53,505 (115) %

*Percentage change not meaningful.

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.

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.

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.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 38

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

Nine Months Ended September 30,

36,190 43,757

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$ 51,992 $ 55,791

(1) Vafseo entered the U.S.

market in January 2025.

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

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.

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.

(1) Includes the authorized generic version of Auryxia sold and distributed by our AG Distributor during the three months ended March 31, 2026 and 2025.

License, Collaboration and Other Revenue— License, collaboration and other revenue was $1.6 million for the three months ended March 31, 2026, compared to $1.5 million for the three months ended March 31, 2025.

Cost of Goods Sold—Cost of Product and Other Revenue— Cost of product and other revenue was $12.3 million for the three months ended March 31, 2026 compared to $7.6 million for the three months ended March 31, 2025.

The increase was primarily due to an increase in inventory write-downs as a result of excess, obsolescence, scrap or other reasons during the three months ended March 31, 2026.

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.

Cost of product and other revenue for Vafseo was $1.4 million for the three months ended March 31, 2026, comprised of manufacturing and overhead costs as the associated inventory costs such as raw materials, drug substance and drug product conversion costs were expensed previously.

If Vafseo inventory sold during the three months ended March 31, 2026 was valued at cost, our cost of product and other revenue would have been $6.2 million.

As of March 31, 2026, we had $24.6 million of reduced-cost Vafseo inventory.

We expect our cost of product and other revenue for Vafseo will increase, reflecting the full cost of manufacturing, subsequent to the utilization of our reduced-cost Vafseo inventory.

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.

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.

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):

Nine Months Ended September 30,

Vafseo clinical trial and other external costs $ 14,914 $ 6,337

External costs for other programs, including feasibility and new processes and methods associated with commercial product 3,985 4,252

R&D Expenses— R&D expenses were $14.8 million for the three months ended March 31, 2026, compared to $9.8 million for the three months ended March 31, 2025.

The increase was primarily driven by increased clinical trial activities related to praliciguat and AKB-9090 as well as higher headcount related costs during the three months ended March 31, 2026.

The following table summarizes our external research and development expenses by program, as well as costs not allocated to programs, for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Clinical trial and related external costs (1) :

Vafseo and Auryxia $ 3,478 $ 1,637

Mid-stage pipeline assets (praliciguat and AKB-097) 1,865 216

Early-stage pipeline assets (AKB-9090 and AKB-10108) 956 1,115

Non-program specific 1,471 1,532

Total external R&D expenses 7,770 4,500

1 unchanged sentence

Total R&D expenses $ 14,807 $ 9,754

(1) See the section titled "Business Overview" for details on our current product portfolio and development pipeline.

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.

Selling, General and Administrative Expenses— Selling, general and administrative expenses were $30.4 million for the three months ended March 31, 2026, compared to $25.7 million for the three months ended March 31, 2025.

The increase was driven by higher headcount related costs during the three months ended March 31, 2026.

License Expenses— License expenses related to royalties due to Panion for sales of Riona in Japan were $0.7 million for each of the three months ended March 31, 2026 and 2025.

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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.

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.

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.

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.

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.

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.

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.

Income Tax Expense— Income tax expense was $0.6 million for the nine months ended September 30, 2025.

There was no income tax expense for the nine months ended September 30, 2024.

Other Expense, Net— Other expense, net, was $4.7 million for the three months ended March 31, 2026, compared to $7.6 million for the three months ended March 31, 2025.

The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with a Termination and Settlement Agreement with CSL Vifor, or the Vifor Termination Agreement, as well as higher interest income related to our money market funds.

See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties , included in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Form 10-Q for further information.

Change in Fair Value of Warrant Liability— Change in fair value of warrant liability was $0.5 million and $0.2 million for the three months ended March 31, 2026 and 2025, respectively.

Income Tax Expense— Income tax expense was $0.1 million for the three months ended March 31, 2026.

There was no income tax expense for the three months ended March 31, 2025.

Liquidity and Capital Resources

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

As of March 31, 2026, we had cash and cash equivalents of $162.6 million and restricted cash of $1.7 million.

To date, we have funded our operations principally through sales of our common stock, including through our employee stock purchase plan, product sales, payments received from our collaboration and licensing partners, borrowings under term loans, a working capital payment from CSL Vifor also referred to as a Working Capital Fund liability and a royalty transaction.

From inception through September 30, 2025, we raised approximately $929.2 million of net proceeds from the sale of equity, including $567.9 million from various underwritten public offerings, $291.3 million from at-the-market offerings pursuant to our sales agreement with Jefferies LLC and prior sales agreements with Cantor Fitzgerald & Co., and $70.0 million from the sale of 7,571,429 shares of common stock to CSL Vifor.

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.

From inception through March 31, 2026, we raised approximately $929.2 million of net proceeds from the sale of equity, including $567.9 million from various underwritten public offerings, $291.3 million from at-the-market, or ATM , offerings, pursuant to our sales agreement with Jefferies LLC, or Jefferies , and prior sales agreements with Cantor Fitzgerald & Co., and $70.0 million from the sale of 7,571,429 shares of common stock to CSL Vifor.

During the three months ended March 31, 2026, we did not sell any shares of our common stock under the ATM offering with Jefferies.

We incurred net loss of $9.1 million and generated net income of $6.1 million during the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $1.7 billion.

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.

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.

Following LoE, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S.

On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia, which has subsequently entered the market.

We expect Teva's entry into the market, and the entry of any additional generic versions of Auryxia that may be approved in addition to our AG Distributor, will adversely impact our revenue.

However, the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics that enter the market, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

We believe our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are sufficient to fund our current operating plan for at least two years, including to commercialize Vafseo and Auryxia and advance our existing programs.

However, if our operating performance deteriorates significantly from the levels expected in our long-term operating plan, including if we do not achieve our future anticipated Vafseo revenue projections, it would have an adverse effect on our liquidity and capital resources and could affect our ability to achieve and maintain profitability or continue as a going concern in the future.

3 unchanged sentences

Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 40

financing may not be available to us in amounts or on terms acceptable to us, if at all.

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.

5 unchanged sentences

Risk Factors under the heading "Risks Related to our Financial Position, Need for Additional Capital and Growth Strategy."

Akebia Therapeutics, Inc.

| Form 10-Q | Page 36

Contractual Obligations and Commitments

1 unchanged sentence

BlackRock Term Loans

On January 29, 2024, or the Closing Date , we entered into the BlackRock Credit Agreement, which provides for a senior secured term loan facility, in the aggregate principal amount of $55.0 million, or the Term Loan Facility .

The Term Loan Facility was available in three tranches (i) Tranche A — $37.0 million was funded on the Closing Date and used to repay the Pharmakon Term Loans;

(ii) Tranche B — $8.0 million was funded on April 19, 2024, and (iii) Tranche C — $10.0 million was funded on February 3, 2025, collectively, the Term Loans .

On January 29, 2024, or the Closing Date , we entered into the Agreement for the Provision of a Loan Facility, as amended, or the BlackRock Credit Agreement, with Kreos Capital VII (UK) Limited , or Kreos , which are funds and accounts managed by BlackRock Inc., collectively, BlackRock .

The BlackRock Credit Agreement provides for a senior secured term loan facility, in the aggregate principal amount of up to $55.0 million, or the Term Loan Facility .

The Term Loan Facility was available in three tranches (i) Tranche A — $37.0 million was funded on the Closing Date;

(ii) Tranche B — $8.0 million was funded on April 19, 2024;

and (iii) Tranche C — $10.0 million was funded on February 3, 2025, or the Tranche C Closing Date , collectively, the Term Loans .

The Term Loan Facility matures on January 29, 2028, or the BlackRock Maturity Date .

On February 3, 2025, we and Kreos entered into a Second Amendment to the BlackRock Credit Agreement, or the Second Amendment , which, among other things, extended the expiry date of Tranche C from December 31, 2024 to the Tranche C Closing Date, or the Extended Tranche C .

Tranche C was available subject to receipt of a certain amount of cumulative gross cash proceeds after the Closing Date in the form of equity or equity linked securities in one or more series of transactions.

The terms of the Extended Tranche C are substantially similar to the terms of the original Tranche C, however, interest accrued on the Extended Tranche C as if it was advanced on December 31, 2024.

We are required to make interest-only payments until December 31, 2026 after which, we will begin making equal monthly principal payments.

In the event of certain prespecified events, the repayment schedule will be accelerated.

The Term Loan Facility will accrue interest at a floating annual rate equal to the sum of (i) term Secured Overnight Financing Rate, or SOFR , for a tenor of one month (subject to a floor of 4.25% per annum) plus (ii) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate).

The Term Loan Facility accrues interest at a floating annual rate equal to the sum of (i) term Secured Overnight Financing Rate, or SOFR , for a tenor of one month (subject to a floor of 4.25% per annum) plus (ii) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate).

During the continuance of any payment event of default the interest rate on such overdue sum will automatically increase by an additional 3.0% per annum, and may be subject to an additional late fee of 2.0% of such overdue sum.

4 unchanged sentences

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.

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.

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, or the Initial Warrant , 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.

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.

On July 23, 2025, as a result of the cashless exercise, we issued 1,408,588 shares of our common stock to the Warrant Holder.

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

Liability Related to Settlement Royalties

Akebia Therapeutics, Inc.

| Form 10-Q | Page 41

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.

Pursuant to the terms of the Vifor Termination Agreement, we 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.

The Settlement Royalty Payments commenced upon the first sale of Vafseo by us 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.

Akebia Therapeutics, Inc.

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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.

4 unchanged sentences

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.

The annual effective interest rate as of March 31, 2026 was 21.2% which is reflected as interest expense in the unaudited condensed consolidated statements of operations and comprehensive income (loss).

We recognized interest expense related to the liability related to settlement royalties of $3.6 million for the three months ended March 31, 2026.

As of March 31, 2026, $15.4 million and $54.8 million of the liability related to settlement royalties is classified as a current and non-current liability, respectively.

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 in Part I, Item 1 of this Form 10-Q for further information.

5 unchanged sentences

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.

As of March 31, 2026, $23.4 million and $16.4 million of the Working Capital Fund liability is classified as a current and non-current liability, respectively, based on management’s estimated timing of the repayment of the Working Capital Fund liability to CSL Vifor.

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 in Part I, Item 1 of this Form 10-Q for further information.

Liability Related to Sale of Future Royalties

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 .

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 TPC 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 TPC, or the TPC 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.

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| Form 10-Q | Page 42

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.

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.

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.

The annual effective interest rate as of March 31, 2026 was 0%.

We retain the right to receive all potential future regulatory milestones for Vafseo under the TPC Agreement.

We recorded non-cash royalty revenue of $0.3 million and $0.4 million during the three months ended March 31, 2026 and 2025, respectively.

As of March 31, 2026, $1.4 million and $50.4 million of the liability related to the sale of future royalties is classified as a current and non-current liability, respectively.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 38

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 in Part I, Item 1 of this Form 10-Q for further information.

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Letter of Credit

As of September 30, 2025, in connection with the Cambridge Lease (as defined below), we had $1.7 million in a letter of credit outstanding.

As of March 31, 2026, in connection with our office and laboratory space in Cambridge, Massachusetts, or the Cambridge Lease , we had $1.7 million in a letter of credit outstanding.

Director and Officer Indemnification

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We are party to contractual obligations involving commitments to make payments to third parties in the future.

Certain contractual obligations are reflected on our condensed consolidated balance sheet as of September 30, 2025, while others are considered future obligations.

Our material cash requirements as of September 30, 2025, include contractual obligations and commitments arising in the normal course of business, including leases, license agreements, manufacturing agreements and unconditional purchase commitments which are described in more detail below.

Certain contractual obligations are reflected on our unaudited condensed consolidated balance sheet as of March 31, 2026, while others are considered future obligations.

Our material cash requirements as of March 31, 2026, include contractual obligations and commitments arising in the normal course of business, including leases, license agreements, manufacturing agreements and unconditional purchase commitments which are described in more detail below.

Cambridge Lease

We lease approximately 65,167 square feet of office, storage and laboratory space in Cambridge, Massachusetts under non-cancelable operating leases, collectively the Cambridge Lease .

The office, storage and lab lease expires on September 11, 2026, and we are currently marketing the furnished office space for sublease.

See Note 9, Leases , 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.

We lease approximately 65,167 square feet of office, storage and laboratory space under the Cambridge Lease.

The office and storage lease expires on September 11, 2026 and the lab lease expires on October 31, 2026.

Waltham Lease

In January 2026, we entered into the Waltham Lease.

We intend to relocate our corporate headquarters to Waltham in September 2026.

See Note 9, Leases , in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the Cambridge Lease and Waltham Lease.

License Agreements

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Cyclerion Agreement

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.

Under the Cyclerion Agreement, as amended, Cyclerion is eligible to receive up to an aggregate of $198.5 million from us in specified development and regulatory milestone payments on a product-by-product basis.

In June 2021, we entered into the Cyclerion Agreement, as amended in December 2024, under which we obtained an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral soluble guanylate cyclase stimulator.

Under the Cyclerion Agreement, as amended, Cyclerion is eligible to receive up to an additional aggregate of $197.5 million from us in specified development and regulatory milestone payments on a product-by-product basis.

Cyclerion will also be eligible to receive specified commercial milestones as well as tiered royalties ranging from mid-single-digit percentage to twenty percent of net sales, on a product-by-product basis, and subject to reduction upon expiration of patent rights or the launch of a generic product in the territory.

See Note 10, Commitments and Contingencies , 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.

Q32 Purchase Agreement

On November 28, 2025, or the APA Closing Date , we entered into an Asset Purchase Agreement, or the Q32 Purchase Agreement , with Q32, pursuant to which we purchased and assumed from Q32 substantially all assets and liabilities of Q32 and its affiliates related to the research, development, manufacture and commercialization of Q32's clinical-stage

Akebia Therapeutics, Inc.

| Form 10-Q | Page 39

See Note 10, Commitments and Contingencies , 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.

development candidate known as ADX-097 (now referred to as AKB-097) worldwide for the treatment, prevention or diagnosis of any disease or condition in humans.

AKB-097, which has been evaluated in a Phase 1 clinical trial in healthy volunteers, in a tissue-targeted C3d-Factor H fusion protein complement inhibitor with the potential to treat rare kidney diseases.

Under the terms of the Q32 Purchase Agreement, we (i) made an upfront payment of $7.0 million on the APA Closing Date, (ii) will make an additional upfront payment of $3.0 million on the six-month anniversary of the APA Closing Date, (iii) will make certain milestone payments upon the achievement of specified development and regulatory milestone events related to AKB-097 up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the earlier of initiation of a Phase 2 clinical trial and December 31, 2026, (iv) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the net sales of AKB-097 up to an aggregate amount equal to $487.5 million, and (v) will make certain royalty payments based on the net sales of AKB-097 with royalty percentage tiers ranging from the low single digits to mid-teen percentages.

The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last-to-expire valid claim of any transferred patent right that covers such product in such country, and (b) the tenth anniversary of the first commercial sale of such product.

Manufacturing Agreements

We have various supply arrangements to which we are a party, and we are obligated to pay for drug substance and drug product for commercial use.

Under one of our agreements, we are required to purchase a minimum quantity of Auryxia drug substance at a predetermined price.

We are also obligated to purchase a certain percentage of the global demand for Vafseo drug substance and drug product based on certain quarterly and annual forecasts we provide to certain suppliers.

We are obligated to purchase a certain percentage of the global demand for Vafseo drug substance and drug product based on certain quarterly and annual forecasts we provide to certain suppliers.

Our supply agreements for Vafseo drug substance and drug product provide for a volume-based pricing structure.

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See Note 10, Commitments and Contingencies , 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.

Amounts Due Under Former Manufacturing and Unconditional Purchase Commitments

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.

See Note 10, Commitments and Contingencies , 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.

Other Third Party Contracts

Unconditional Purchase Commitments

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 $86.8 million as of September 30, 2025.

In addition, we contract with various organizations to conduct R&D activities with remaining contract costs to us of approximately $81.5 million as of March 31, 2026.

The scope of the services under these R&D contracts can be modified upon mutual agreement of the parties, and the contracts or scope of services can be cancelled by us upon written notice.

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The following table provides a summary of cash flow data for each applicable period:

Nine Months Ended September 30,

Three Months Ended March 31,

NET CASH PROVIDED BY/(USED IN) ( in thousands ):

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Operating Activities

Net cash provided by operating activities was $36.9 million for the nine months ended September 30, 2025.

Net cash provided by operating activities for the nine months ended September 30, 2025 consisted of net income of $6.9 million as well as net non-cash adjustments of $35.4 million, including a change in fair value of the warrant liability of $5.4 million, offset by a reduction of $5.4 million in working capital.

Net cash used in operating activities was $36.2 million for the nine months ended September 30, 2024.

Net cash used in operating activities consisted of a net loss of $46.6 million and net non-cash adjustments of $46.9 million, including amortization of our intangible asset of $27.0 million, and a reduction of $36.4 million in working capital.

Investing Activities

Net cash used in operating activities was $21.2 million for the three months ended March 31, 2026 and consisted of a net loss of $9.1 million and net non-cash adjustments of $12.4 million, including a change in fair value of the warrant liability of $0.5 million, and a reduction of $24.5 million in working capital.

Net cash used in operating activities was $13.6 million for the three months ended March 31, 2025 and consisted of 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.

Akebia Therapeutics, Inc.

| Form 10-Q | Page 40

Immaterial net cash was used in investing activities for each of the nine months ended September 30, 2025 and 2024.

Investing Activities

Net cash used in investing activities was $0.1 million for the three months ended March 31, 2026 and was comprised of purchases of equipment.

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.

Financing Activities

Net cash provided by financing activities was $77.8 million for the nine months ended September 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.

Net cash provided by financing activities was $27.3 million for the nine months ended September 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 $20.4 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.

Net cash used in financing activities was $0.9 million for the three months ended March 31, 2026, which primarily consisted of payments to CSL Vifor of $0.5 million and $0.6 million related to the Working Capital Fund liability and liability related to settlement royalties, respectively.

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.

Recent Accounting Pronouncements

For a discussion of recent accounting pronouncements, see Note 2, Summary of Significant Accounting Policies , of the Notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Critical Accounting Estimates and Significant Judgments

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations are based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S.

generally accepted accounting principles.

The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the related disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, other long-term liabilities, a liability related to settlement royalties, revenues, including various rebates, returns and reserves related to product sales, inventories, classification of expenses between cost of goods sold, R&D and selling, general and administrative, long-term assets, including our right-of-use assets and goodwill.

We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates under different assumptions or conditions.

The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, including the current or long-term classification of such assets, liabilities and expenses, classification of the expenses and the related disclosure of contingent assets and liabilities.

We monitor our estimates on an ongoing basis for changes in facts and circumstances, and material changes in these estimates could occur in the future.

Changes in estimates are recorded in the period in which they become known.

We base our estimates on historical experience and other assumptions that we believe to be reasonable under the circumstances.

Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.

In making estimates and judgments, management employs critical accounting policies.

During the nine months ended September 30, 2025, there were no material changes to our methodologies used for our critical accounting estimates as reported in our 2024 Form 10-K.

Quantitative and Qualitative Disclosures about Market Risk.

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide information under this item.

During the three months ended March 31, 2026, there were no material changes to our methodologies used for our critical accounting estimates as reported in our 2025 Form 10-K.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis