# Akebia Therapeutics, Inc. (AKBA)

Informational only - not investment advice.

CIK: 0001517022
SIC: 2834 Pharmaceutical Preparations
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2834 Pharmaceutical Preparations](/industry/2834/)
Latest 10-K filed: 2026-02-26
SEC page: https://www.sec.gov/edgar/browse/?CIK=1517022
Filing source: https://www.sec.gov/Archives/edgar/data/1517022/000151702226000020/akba-20251231.htm

## At a glance

FY2025 · period end 2025-12-31 · filed 2026-02-26 · accession 0001517022-26-000020 · source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001517022.json

| Metric | Value | FY | Provenance |
| --- | ---: | ---: | --- |
| Revenue | 236,196,000 USD | 2025 | verified |
| Net income | -5,345,000 USD | 2025 | verified |
| Assets | 376,565,000 USD | 2025 | verified |
| Free cash flow | 67,701,000 USD | 2025 | computed |
| Net margin | -2.26% | 2025 | computed |
| Operating margin | 9.95% | 2025 | computed |
| Revenue YoY | +47.46% | 2025 | computed |
| ROE | -16.39% | 2025 | computed |

Computed values are grepcent-computed from the verified facts above and may differ from ratios the company itself reports. Free cash flow = operating cash flow − capital expenditures. Net margin = net income ÷ revenue. Operating margin = operating income ÷ revenue. Revenue YoY = FY2025 revenue ÷ FY2024 revenue − 1 (consecutive fiscal years only). ROE = net income ÷ period-end stockholders' equity.

No market price, no rating, no forecast on this site. Not investment advice.

### Peer percentile fingerprint

| Ratio | AKBA | Peer median | Percentile | N |
| --- | ---: | ---: | ---: | ---: |
| Net margin | -2.3% | 1.0% | 46 | 107 |
| Operating margin | 9.9% | -1.3% | 62 | 100 |
| Revenue growth | 47.5% | 14.7% | 70 | 127 |
| FCF margin | 28.7% | -14.0% | 87 | 127 |
| ROE | -16.4% | -30.7% | 64 | 171 |
| ROA | -1.4% | -21.8% | 71 | 187 |
| Liabilities / equity | 10.55 | 0.38 | 96 | 173 |
| Current ratio | 1.55 | 4.89 | 6 | 188 |

Percentile = share of the N covered peers reporting that ratio whose value is lower (ties counted half); computed among grepcent-covered companies in SIC industry 2834 Pharmaceutical Preparations, not the whole market. A higher percentile means a higher value of the ratio, not a better company. Ratios with fewer than 8 reporting peers are omitted. Latest reported values per company; fiscal periods may differ. Descriptive arithmetic - not a score, rating, or ranking.

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Revenue | 236196000 | USD | 2025 | 2026-02-26 |
| Net income | -5345000 | USD | 2025 | 2026-02-26 |
| Assets | 376565000 | USD | 2025 | 2026-02-26 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-26. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001517022.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Revenue | 1,535,000 | 181,227,000 | 207,742,000 | 335,001,000 | 294,644,000 | 211,650,000 | 292,484,000 | 194,623,000 | 160,180,000 | 236,196,000 |
| Net income | -135,747,000 | -73,671,000 | -143,588,000 | -279,659,000 | -384,841,000 | -282,024,000 | -94,226,000 | -51,925,000 | -69,410,000 | -5,345,000 |
| Operating income | -136,460,000 | -76,674,000 | -178,161,000 | -286,288,000 | -377,826,000 | -264,502,000 | -80,779,000 | -46,256,000 | -50,472,000 | 23,499,000 |
| Diluted EPS |  |  |  | -2.36 | -2.78 | -1.70 | -0.52 | -0.28 | -0.33 | -0.02 |
| Operating cash flow | 57,906,000 | -56,159,000 | -97,494,000 | -257,441,000 | -110,388,000 | -252,965,000 | -73,154,000 | -23,384,000 | -40,659,000 | 67,992,000 |
| Capital expenditures | 2,662,000 | 1,622,000 | 1,606,000 | 6,655,000 | 317,000 | 59,000 | 114,000 | 0.00 | 33,000 | 291,000 |
| Assets | 300,216,000 | 364,247,000 | 996,540,000 | 771,201,000 | 644,139,000 | 529,347,000 | 356,054,000 | 241,703,000 | 220,670,000 | 376,565,000 |
| Liabilities | 232,096,000 | 241,673,000 | 360,612,000 | 376,444,000 | 396,521,000 | 455,339,000 | 350,824,000 | 272,287,000 | 269,855,000 | 343,955,000 |
| Stockholders' equity | 68,120,000 | 122,574,000 | 635,928,000 | 392,877,000 | 244,354,000 | 74,008,000 | 5,230,000 | -30,584,000 | -49,185,000 | 32,610,000 |
| Cash and cash equivalents | 187,335,000 | 70,156,000 | 104,644,000 | 147,449,000 | 228,698,000 | 149,800,000 | 90,466,000 | 42,925,000 | 51,870,000 | 184,844,000 |
| Free cash flow | 55,244,000 | -57,781,000 | -99,100,000 | -264,096,000 | -110,705,000 | -253,024,000 | -73,268,000 | -23,384,000 | -40,692,000 | 67,701,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net margin |  | -40.65% | -69.12% | -83.48% | -130.61% | -133.25% | -32.22% | -26.68% | -43.33% | -2.26% |
| Operating margin |  | -42.31% | -85.76% | -85.46% | -128.23% | -124.97% | -27.62% | -23.77% | -31.51% | 9.95% |
| Return on equity | -199.28% | -60.10% | -22.58% | -71.18% | -157.49% | -381.07% |  |  |  | -16.39% |
| Return on assets | -45.22% | -20.23% | -14.41% | -36.26% | -59.75% | -53.28% | -26.46% | -21.48% | -31.45% | -1.42% |
| Liabilities / equity | 3.41 | 1.97 | 0.57 | 0.96 | 1.62 | 6.15 | 67.08 |  |  | 10.55 |
| Current ratio | 2.59 | 2.54 | 1.76 | 1.49 | 1.98 | 1.04 | 1.43 | 1.18 | 1.41 | 1.55 |

## As-reported value updates

12 tracked differences above grepcent's stated thresholds were found between the earliest XBRL-filed value and the value currently on file for the same fiscal period.

Ledger: /company/AKBA/revisions/


## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-08-05. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001517022.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2022-Q3 | 2022-09-30 |  |  | -0.28 | reported discrete quarter |
| 2023-Q1 | 2023-03-31 |  |  | -0.14 | reported discrete quarter |
| 2023-Q2 | 2023-03-31 |  |  | -0.15 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | -11,172,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 | 42,046,000 |  | -0.08 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 | 56,196,000 | 614,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 | 32,607,000 | -17,985,000 | -0.09 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -17,985,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 | 43,648,000 |  | -0.04 | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | -8,582,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 | 37,428,000 |  | -0.10 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 | 46,497,000 | -22,804,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 | 57,336,000 | 6,112,000 | 0.03 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | 6,112,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-06-30 | 62,472,000 |  | 0.00 | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | 247,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-09-30 | 58,766,000 |  | 0.00 | reported discrete quarter |
| 2025-Q4 | 2025-12-31 | 57,622,000 | -12,244,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 | 53,544,000 | -9,054,000 | -0.03 | reported discrete quarter |
| 2026-Q2 | 2026-03-31 |  | -9,054,000 |  | reported discrete quarter |
| 2026-Q2 | 2026-06-30 | 49,128,000 |  | -0.03 | reported discrete quarter |

## Filed narrative (10-K & 10-Q)

## Business

Verbatim Item 1 Business section from AKBA's latest 10-K: [/company/AKBA/business/](/company/AKBA/business/).

## Risk Factors

Verbatim Item 1A Risk Factors from AKBA's latest 10-K: [/company/AKBA/risk-factors/](/company/AKBA/risk-factors/).

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1517022/000151702226000051/akba-20260630.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary.
Confidence: high
Filing date: 2026-08-05
Report date: 2026-06-30

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

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 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. As a result of many factors, such as those set forth under “Risk Factors” in Part II, Item 1A. of this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.

Business Overview

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 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. Our two commercial products address certain complications of kidney disease.

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. Vafseo is the only oral hypoxia inducible factor, or HIF, based treatment available in the U.S. Vafseo entered the market in January 2025.

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. for two indications: (1) the control of serum phosphorus levels in adult patients with dialysis dependent chronic kidney disease, or DD-CKD, and (2) the treatment of iron deficiency anemia, or IDA, in adult patients with non-dialysis-dependent chronic kidney disease, or NDD-CKD.

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

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 ebribafusp, are being evaluated to target areas of unmet need. In June 2021, we licensed praliciguat from Cyclerion Therapeutics, Inc., or Cyclerion, via an exclusive global license, which includes certain intellectual property rights to research, develop and commercialize the asset. Praliciguat is an oral, once-daily soluble guanylate cyclase, 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.

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

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

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.

Factors Affecting Our Performance and Results of Operations

Financial Components

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 for Auryxia, Mylan Therapeutics, Inc., or AG Distributor. Our net product revenue includes many variables, including judgments and estimates of discounts, rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year.

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

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

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

Research and Development Expenses

R&D expenses consist primarily of costs incurred for the development of Vafseo and costs associated with our pipeline which includes:

•personnel-related expenses, including salaries, bonuses, employee benefits, stock-based compensation and travel expenses for employees engaged in R&D functions;

•costs associated with feasibility and potential new manufacturing processes and methods for our commercial products;

•regulatory registration and related fees for non-commercial products;

•expenses incurred under agreements with contract research organizations, or CROs, and investigative sites that conduct our clinical trials;

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•the cost of acquiring, developing and manufacturing clinical trial materials through CDMOs;

•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 known as ebribafusp; and

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

R&D costs are expensed as incurred. Advance payments made for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses and other current assets. The prepaid amounts are expensed as the benefits are consumed. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and our clinical sites.

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 June 30, 2026, we have incurred $1.8 billion in R&D expenses. We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Vafseo, praliciguat, ebribafusp, AKB-9090 and any other product or product candidate, including those that may be in-licensed or acquired.

A significant portion of our R&D costs have been external costs, which we track on a program-by-program basis as well as costs related to possible new manufacturing processes and methods associated with our commercial products. These external costs include fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials and costs related to acquiring and manufacturing clinical trial materials, including costs paid to CDMOs to manufac

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A (excerpt)

Latest 10-K Item 7 source: https://www.sec.gov/Archives/edgar/data/1517022/000151702226000020/akba-20251231.htm
Complete FY 2025 MD&A: /company/AKBA/mda/fy2025/

Extracted structurally from real Item 7 body heading to real Item 7A/8 boundary.
Confidence: high
Filing date: 2026-02-26
Report date: 2025-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Annual Report on Form 10-K, or Form 10-K, including this management's discussion and analysis of financial condition and results of operations, contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those described in or implied in these forward-looking statements as a result of various factors, including those factors set forth in the “Risk Factors” section included in Part I, Item 1A of this Form 10-K. All references to years, unless otherwise noted, refer to our fiscal years, which end on December 31. For purposes of this section, all references to “we,” “us,” “our,” “Akebia,” or the “Company” refer to Akebia Therapeutics, Inc. and its consolidated subsidiaries.

The following discussion and analysis should also be read in conjunction with the accompanying audited consolidated financial statements and related notes included in Part II, Item 8 of this Form 10-K. This section discusses 2025 and 2024 financial condition, and results of operations and year-to-year comparisons between 2025 and 2024. For discussion of 2024 items and year-over-year comparisons between 2024 and 2023 that are not included in this 2025 Form 10-K, refer to “Item 7. – Management’s Discussion and Analysis of Financial Condition and Results of Operations” found in our Form 10-K for the year ended December 31, 2024, that was filed with the Securities and Exchange Commission on March 13, 2025.

Business Overview

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 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 United States, or U.S., healthcare system, potentially affecting approximately 35.5 million

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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 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. The current U.S. market opportunity for the treatment of anemia due to CKD in patients with dialysis is approximately $1 billion based on current erythropoiesis stimulating agent, or ESA, pricing. Vafseo is the only oral hypoxia inducible factor, or HIF, based treatment available in the U.S. Vafseo entered the market in January 2025, at which time we had commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. Throughout 2025, we worked closely with dialysis organizations as their medical teams developed, implemented and operationalized protocols to enable prescribers to write Vafseo prescriptions for clinically appropriate patients. Currently, approximately 290,000 dialysis patients in the U.S. have prescribing access to Vafseo.

Vafseo is approved for use in adults in 37 countries and is marketed in certain countries outside the U.S. by our partners. See Part I, Item 1, License and Collaboration Agreements, for details.

Auryxia® (ferric citrate) is an orally administered medicine approved and marketed in the U.S. for two indications: (1) the control of serum phosphorus levels in adult patients with dialysis dependent chronic kidney disease, or DD-CKD, and (2) the treatment of iron deficiency anemia, or IDA, in adult patients with non-dialysis-dependent chronic kidney disease, or NDD-CKD.

Today, we market Auryxia in the U.S. Auryxia became part of our portfolio in 2018 and has historically contributed meaningful revenue to the business. In March 2025, Auryxia reached loss of exclusivity, or LoE. On January 22, 2026, Teva Pharmaceuticals Ltd., or Teva, received tentative approval for its Abbreviated New Drug Application for Auryxia. Currently, there is only one authorized generic for Auryxia sold by our distributor, but we expect additional generic competition in 2026. If additional generics are approved and enter the market, we expect it will adversely impact our revenue.

Ferric citrate is approved for use and marketed in certain countries outside the U.S. by our partners. See Part I, Item 1, License and Collaboration Agreements, for details.

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.

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, 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, and we expect to initiate a Phase 1 study in healthy volunteers in the first half of 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.

Akebia Therapeutics, Inc. | Form 10-K | Page 121

Table of Contents

Factors Affecting Our Performance and Results of Operations

Financial Components

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

We had exclusive rights under a series of patents and patent applications to commercialize Auryxia in the U.S. that protected us from generic drug competition until March 20, 2025. Following LoE, since March 2025, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S. 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.

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, 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 our firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S. and Japan product sales recognized during the period.

Cost of product and other revenue also includes costs to manufacture drug product provided to TPC and Medice for commercial sale 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. 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, cost of product and other revenue included the amortization of development product rights for Auryxia through the end of 2024.

Research and Development Expenses

R&D expenses consist primarily of costs incurred for the development of Vafseo and costs associated with our pipeline which includes:

•personnel-related expenses, including salaries, bonuses, employee benefits, stock-based compensatio

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]

Read the full FY 2025 MD&A: /company/AKBA/mda/fy2025/
All MD&A years: /company/AKBA/mda/


## MD&A history

Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. Each year's full verbatim text is on its own sub-page.

- [FY 2024 MD&A](/company/AKBA/mda/fy2024/): filed 2025-03-13; accession 0001628280-25-012470 (https://www.sec.gov/Archives/edgar/data/1517022/000162828025012470/akba-20241231.htm)
- [FY 2023 MD&A](/company/AKBA/mda/fy2023/): filed 2024-03-14; accession 0001628280-24-011270 (https://www.sec.gov/Archives/edgar/data/1517022/000162828024011270/akba-20231231.htm)
- [FY 2022 MD&A](/company/AKBA/mda/fy2022/): filed 2023-03-10; accession 0001628280-23-007539 (https://www.sec.gov/Archives/edgar/data/1517022/000162828023007539/akba-20221231.htm)
- [FY 2021 MD&A](/company/AKBA/mda/fy2021/): filed 2022-03-01; accession 0001628280-22-004522 (https://www.sec.gov/Archives/edgar/data/1517022/000162828022004522/akba-20211231.htm)


## FDA-approved drug applications

Applications listed under this company's exact-matched sponsor name. Approved applications only.

No resolved FDA applications were found for this company under the exact-unique, approved-only publish rule.

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

This list covers FDA applications whose listed sponsor name maps to this company by an exact-unique match; applications listed under sponsor names not mapped to this company (subsidiaries, name variants, joint ventures) are absent.


## Macro cross-references

Indicators mapped to this company's SIC classification (industry 2834 Pharmaceutical Preparations) by grepcent's deterministic macro-sector crosswalk. A navigational mapping, not a statistical or causal claim.

- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm

Macro-to-micro threads including this sector: [Inflation (CPI / PCE / PPI)](/thread/inflation-cpi-pce-ppi/), [US labor market](/thread/us-labor-market/), [Growth & output](/thread/growth-output/), [Money & trade](/thread/money-trade/), [Government finances](/thread/government-finances/), [Sector employment](/thread/sector-employment/), [Industrial orders & inventories](/thread/industrial-orders/), [Trade & external](/thread/trade-external/).

All macro indicators: /indicators/


## For LLMs & downloads

Markdown twin: /company/AKBA.md · JSON record: /company/AKBA.json · verified financials: /company/AKBA/financials.json / /company/AKBA/financials.csv · machine TOC for the whole site: /llms.txt