Akebia Therapeutics Inc.

Company Overview

Business Model: Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the discovery, development, and commercialization of therapeutics for patients with kidney disease. Its primary revenue generation mechanisms involve the commercialization of its approved products, Vafseo and Auryxia, and potential future product candidates from its development pipeline, supported by licensing and collaboration agreements.

Market Position: Akebia Therapeutics, Inc. operates within the chronic kidney disease (CKD) market, which affects approximately 35.5 million patients in the U.S. The company's lead commercial product, Vafseo, is the only oral hypoxia inducible factor (HIF) based treatment approved in the U.S. for anemia due to CKD in adult patients on dialysis. This positions Vafseo uniquely against injectable erythropoiesis-stimulating agents (ESAs). Auryxia, an orally administered medicine, addresses serum phosphorus control in dialysis-dependent CKD and iron deficiency anemia in non-dialysis-dependent CKD, but faces increasing generic competition following its Loss of Exclusivity in March 2025.

Recent Strategic Developments:

• Vafseo U.S. Commercial Launch: Vafseo entered the U.S. market in January 2025, following FDA approval in March 2024. By January 2025, commercial supply agreements were in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S., providing prescribing access to approximately 290,000 patients.
• Pipeline Expansion in Rare Kidney Disease: Akebia Therapeutics, Inc. is advancing its mid-stage rare kidney disease pipeline with:
  • Praliciguat: Licensed from Cyclerion Therapeutics, Inc., a Phase 2 clinical trial for focal segmental glomerulosclerosis (FSGS) initiated with the first patient dosed in December 2025.
  • AKB-097: Purchased from Q32 Bio Inc. and Q32 Bio Operations Inc., a Phase 2 basket study is expected to initiate in the second half of 2026 for IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and Lupus Nephritis (LN), with initial data anticipated in 2027.
• Early-Stage HIF Pipeline: A Phase 1 study for AKB-9090, a HIF molecule for cardiac surgery-related acute kidney injury (CS-AKI), is expected to initiate in the first half of 2026. AKB-10108, another HIF molecule, is in preclinical development for retinopathy of prematurity (ROP).
• CSL Vifor Agreement Termination: In July 2024, Akebia Therapeutics, Inc. terminated its license agreement with CSL Vifor, regaining full U.S. commercialization rights for Vafseo, while agreeing to pay CSL Vifor tiered royalty payments and repay a Working Capital Fund contribution.

Geographic Footprint: Akebia Therapeutics, Inc.'s principal executive offices are in Cambridge, Massachusetts, with a planned relocation to Waltham, Massachusetts in September 2026. Vafseo is approved for use in adults in 37 countries, with commercialization in the European Economic Area (EEA), UK, Switzerland, and Australia licensed to Medice, and in Japan and certain other Asian countries to Tanabe Pharma Corporation. Auryxia is licensed to Averoa for the EEA, Turkey, Switzerland, UK, Balkans, and certain Eastern Europe/Middle East countries, and to JT and Torii for Japan.

Financial Performance

Akebia Therapeutics, Inc. reported a net loss of $5.3 million for the year ended December 31, 2025, contributing to an accumulated deficit of $1.7 billion as of the same date. The company anticipates continued losses and requires substantial additional financing to support its operations and strategic initiatives.

Product Portfolio & Pipeline

Vafseo (vadadustat)

Financial Performance:

• Akebia Therapeutics, Inc. recorded $5.7 million in license revenue from Riona royalties (related to vadadustat in Japan) for the year ended December 31, 2025.
• The U.S. market opportunity for Vafseo is approximately $1 billion.

Product Portfolio:

• Vafseo is an orally administered hypoxia inducible factor prolyl hydroxylase (HIF-PH) inhibitor.
• Approved by the U.S. FDA in March 2024 for anemia due to CKD in adult patients on dialysis for at least three months.
• Entered the U.S. market in January 2025.
• Approved for use in adults in 37 countries.

Key Growth Drivers:

• Driving Vafseo to be the standard of care for anemia due to CKD in U.S. dialysis patients.
• As of December 31, 2025, nearly 1,000 prescribers from 24 dialysis organizations have written Vafseo prescriptions.
• Commercial supply agreements were in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. by January 2025, providing prescribing access to approximately 290,000 dialysis patients.
• Eligibility for Transitional Drug Add-on Payment Adjustment (TDAPA) for two years starting January 1, 2025, followed by a Medicare payment adjustment for three additional years.

Market Dynamics:

• Vafseo is the only oral HIF-based treatment in the U.S., offering a differentiated mechanism of action compared to injectable erythropoiesis-stimulating agents (ESAs).
• Faces competition from injectable ESAs (e.g., Epogen, Aranesp, Procrit, Eprex, Mircera, biosimilar Retacrit) and other HIF-PH inhibitors in international markets (e.g., Evrenzo/roxadustat in Europe, daprodustat, enarodustat, molidustat in Japan).

Auryxia (ferric citrate)

Financial Performance:

• Akebia Therapeutics, Inc. paid $11.3 million in royalties to Panion for the year ended December 31, 2025, related to ferric citrate.
• No royalties were received from Averoa as of December 31, 2025.

Product Portfolio:

• Auryxia is an orally administered medicine approved and marketed in the U.S. for:
  1. Control of serum phosphorus levels in adult patients with dialysis-dependent chronic kidney disease (DD-CKD).
  2. Treatment of iron deficiency anemia (IDA) in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).

Key Growth Drivers:

• Continued support for Auryxia in its approved indications.
• Inclusion in the ESRD bundle as of January 2025, with TDAPA for phosphate binders through the end of 2026.

Market Dynamics:

• Reached Loss of Exclusivity (LoE) in March 2025.
• Teva Pharmaceuticals Ltd. received tentative approval for its Abbreviated New Drug Application (ANDA) for Auryxia on January 22, 2026.
• Currently, one authorized generic for Auryxia is sold by Akebia Therapeutics, Inc.'s distributor, with additional generic competition expected in 2026.
• Competes with other phosphate binders (e.g., Renagel, Renvela, PhosLo, Fosrenol, Velphoro, XPHOZAH) and various oral and intravenous iron treatments for IDA (e.g., Feraheme, Venofer, Accrufer).

Development Pipeline

Mid-stage rare kidney disease assets:

• Praliciguat:
  • Financial Performance: Akebia Therapeutics, Inc. paid $3.0 million upfront (expensed June 2021), an additional $1.25 million upfront (December 2024), and $0.5 million (September 2025) to Cyclerion Therapeutics, Inc. A $1.0 million regulatory milestone was paid in February 2026 upon first patient dosed in a Phase 2 U.S. trial. Cyclerion Therapeutics, Inc. is eligible for up to $197.5 million in development and regulatory milestones and tiered royalties (mid-single-digit to 20%).
  • Product Portfolio: An oral, once-daily soluble guanylate cyclase (sGC) stimulator.
  • Key Growth Drivers: Currently in a Phase 2 clinical trial for biopsy-confirmed focal segmental glomerulosclerosis (FSGS), with the first patient dosed in December 2025. FSGS affects at least 40,000 people in the U.S., with no FDA-approved drugs.
• AKB-097:
  • Financial Performance: Akebia Therapeutics, Inc. made a $7.0 million upfront payment on November 28, 2025, and an additional $3.0 million upfront payment is due on the six-month anniversary to Q32 Bio Inc. and Q32 Bio Operations Inc. Q32 Bio Inc. and Q32 Bio Operations Inc. are eligible for up to $94.5 million in development and regulatory milestones (including a $2.0 million development milestone by December 31, 2026) and up to $487.5 million in commercial milestones, plus tiered royalties (low single digits to mid-teen percentages).
  • Product Portfolio: An anti-C3d-Factor H fusion protein complement inhibitor.
  • Key Growth Drivers: Akebia Therapeutics, Inc. expects to initiate a Phase 2 basket study in the second half of 2026 to evaluate AKB-097 for IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and Lupus Nephritis (LN), with initial data expected in 2027. These conditions represent significant unmet medical needs with substantial patient populations.

Early-stage pipeline assets:

• AKB-9090: A HIF molecule, expected to initiate a Phase 1 study in healthy volunteers in the first half of 2026 for cardiac surgery-related acute kidney injury (CS-AKI).
• AKB-10108: A HIF molecule in preclinical development, potentially for retinopathy of prematurity (ROP) in neonates.

Capital Allocation Strategy

Shareholder Returns:

• Akebia Therapeutics, Inc. has never declared or paid cash dividends on its common stock and does not anticipate doing so in the foreseeable future. The BlackRock Credit Agreement also precludes dividend payments without prior written consent.
• No issuer purchases of equity securities were reported.

Balance Sheet Position:

• As of December 31, 2025, Akebia Therapeutics, Inc. had $59.0 million in goodwill, $1.2 million of property and equipment, and $3.7 million in right-of-use assets.

Cash Flow Generation:

• The company anticipates continued losses and requires substantial additional financing to fund its operations.
• Akebia Therapeutics, Inc. has a shelf registration statement on Form S-3 allowing the offer and sale of up to $250.0 million in registered securities, including up to $75.0 million of common stock under a sales agreement with Jefferies LLC, of which $32.0 million remains available.
• Warrants were issued to Kreos Capital VII Aggregator SCSp to purchase 3,076,923 shares and 1,153,846 shares of common stock, both at an exercise price of $1.30 per share, exercisable for eight years. On July 21, 2025, 1,408,588 shares of common stock were issued upon cashless exercise of a portion of the Initial Warrant.

Operational Excellence

Production & Service Model: Akebia Therapeutics, Inc. relies entirely on third-party contract manufacturing organizations (CMOs) for the supply of its drug substance and drug product for both Vafseo and Auryxia. The company also utilizes third-party distributors, with Cardinal Health, Inc. serving as the exclusive third-party logistics distribution agent. This model emphasizes external partnerships for manufacturing and distribution, allowing Akebia Therapeutics, Inc. to focus on research, development, and commercialization.

Supply Chain Architecture: Key Suppliers & Partners:

• Vafseo Drug Substance & Product: STA Pharmaceutical Hong Kong Limited and Patheon Inc. are key manufacturers.
• Auryxia Drug Substance & Product: Siegfried Evionnaz SA supplies the drug substance, and Patheon Manufacturing Services LLC (Thermo Fisher) supplies the drug product.
• Distribution: Cardinal Health, Inc. acts as the exclusive third-party logistics distribution agent in the U.S.
• Manufacturing Flexibility: An amendment to the Medice License Agreement in November 2025 allows Medice to manufacture Vafseo tablets using Akebia Therapeutics, Inc.-supplied drug substance, with intellectual property owned by Akebia Therapeutics, Inc.

Facility Network:

• Corporate Headquarters: Akebia Therapeutics, Inc. currently leases approximately 65,167 square feet of office, storage, and laboratory space in Cambridge, Massachusetts.
• Planned Relocation: On January 27, 2026, Akebia Therapeutics, Inc. entered a lease for approximately 43,474 square feet (28,518 sq ft office, 14,956 sq ft lab) in Waltham, Massachusetts, with the intention to relocate its corporate headquarters there in September 2026.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Akebia Therapeutics, Inc. implemented distribution changes in January 2025, including reduced mainline wholesalers and an increased focus on direct sales to dialysis organizations for its commercial products.
• Channel Partners: The company leverages various licensing and collaboration agreements for international market access, including Medice for the EEA, UK, Switzerland, and Australia; Tanabe Pharma Corporation for Japan and certain other Asian countries; and Averoa for the EEA, Turkey, Switzerland, UK, Balkans, and certain Eastern Europe/Middle East countries.

Customer Portfolio: Enterprise Customers:

• Customer Concentration: Three major dialysis organizations—DaVita, Fresenius Medical Care Rx, and USRC—accounted for a significant percentage of gross revenue from Auryxia and Vafseo in the year ended December 31, 2025. This indicates a concentrated customer base within the U.S. dialysis market.
• Strategic Partnerships: Commercial supply agreements for Vafseo were in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. by January 2025.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The chronic kidney disease (CKD) market is substantial, with approximately 35.5 million patients in the U.S. and significant healthcare expenditures. The dialysis segment, in particular, represents a critical area of focus. The market is characterized by the need for innovative treatments for anemia, hyperphosphatemia, and rare kidney diseases, with a trend towards oral therapies where possible. Regulatory pathways for new drugs are complex and lengthy, and pricing and reimbursement are heavily influenced by government programs like Medicare.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• Vafseo (anemia due to CKD):
  • Injectable ESAs: Epogen, Aranesp, Procrit, Eprex, Mircera, and biosimilar Retacrit (epoetin alfa-epbx).
  • Other HIF-PH Inhibitors: Evrenzo/roxadustat (Europe), daprodustat, enarodustat, molidustat (Japan).
• Auryxia (hyperphosphatemia & IDA):
  • Phosphate Binders: Renagel, Renvela, PhosLo, Phoslyra, Fosrenol, Velphoro, OTC calcium carbonate, other metal-based options, and generics. XPHOZAH (tenapanor).
  • Iron Deficiency Anemia (IDA) Treatments: Oral iron supplements (OTC, ferrous sulfate, etc.), IV iron (Feraheme, Venofer, Ferrlicit, Injectafer, Triferic), and Accrufer (ferric maltol).
• Praliciguat (FSGS): No FDA-approved drugs. Competes with existing treatments like steroids, immunosuppressives, antihypertensives, and therapies in development such as FILSPARI/sparsentan (Travere Therapeutics), DMX-200/repagermanium (Dimerix Limited), and others from Apellis Pharmaceuticals, Inc., Boehringer Ingelheim, Sanofi, Vera Therapeutics, and Vertex Pharmaceuticals.
• AKB-097 (IgAN, C3G, LN):
  • IgAN: FDA-approved FABHALTA (iptacopan, Novartis), FILSPARI (sparsentan), TARPEYO (budesonide, Calliditas Therapeutics AB/Asahi Kasei Corporation), VANRAFIA (atrasentan, Novartis), VOYXACT (sibeprenlimab-szsi). Other complement inhibitors in development.
  • C3G: FDA-approved FABHALTA (Novartis, iptacopan) and EMPAVELI (Apellis, pegcetacoplan). Other complement inhibitors in development.
  • LN: FDA-approved BENLYSTA (belimumab, GSK), LUPKYNIS (voclosporin, Aurinia Pharmaceuticals), and GAZYVA (obinutuzumab, Genentech/Biogen). Other therapies in development.

Competitive Response Strategy: Akebia Therapeutics, Inc.'s strategy involves driving Vafseo to be the standard of care in its approved indication, building on its commitment to kidney disease by supporting Auryxia and advancing its rare kidney disease pipeline, and exploring strategic growth opportunities leveraging its HIF biology expertise. The company is actively pursuing clinical development for pipeline assets to address unmet needs in rare kidney diseases.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics:

• Competition: Vafseo faces competition from established injectable ESAs and other HIF-PH inhibitors globally. Auryxia faces significant generic competition following its Loss of Exclusivity in March 2025, with Teva Pharmaceuticals Ltd. receiving tentative ANDA approval in January 2026 and additional generics expected in 2026. This could lead to decreased demand and revenue erosion.
• Technology Disruption: The biopharmaceutical industry is subject to rapid technological change and the introduction of new therapies, which could render Akebia Therapeutics, Inc.'s products or pipeline candidates less competitive or obsolete.
• Customer Concentration: A significant percentage of gross revenue from Auryxia and Vafseo in 2025 was derived from three major dialysis organizations, creating dependency risk.

Operational & Execution Risks

Supply Chain Vulnerabilities:

• Supplier Dependency: Akebia Therapeutics, Inc. relies on third-party contract manufacturing organizations (CMOs) for all drug substance and drug product supply, and on third-party distributors. Any disruption in these relationships or manufacturing processes could impact product availability.
• Geographic Concentration: Manufacturing and supply chain operations may be exposed to regional risks, though the filing does not specify geographic concentration beyond general third-party reliance.
• Capacity Constraints: Reliance on CMOs means Akebia Therapeutics, Inc. is dependent on their capacity and ability to meet demand, which could pose risks if demand increases or if a CMO faces operational issues.

Product Liability:

• Akebia Therapeutics, Inc. faces inherent product liability risk from the clinical and commercial use of Auryxia, Vafseo, and product candidates. Claims could allege manufacturing/design defects, failure to warn, negligence, or other issues, potentially leading to decreased demand, reputational damage, clinical trial delays, significant defense costs, and monetary awards exceeding insurance coverage.

Cybersecurity Risks:

• Akebia Therapeutics, Inc. is subject to security incidents and cyber-attacks, including those using artificial intelligence. Potential impacts include significant costs (rebuilding systems, litigation, regulatory actions, fines), public exposure of personal information (clinical trial participants, Auryxia patients), damage to clinical trial integrity or delays, disruption of development and commercialization, compromise of intellectual property, manipulation of clinical trial data, reputational damage, and diversion of management resources.

Financial & Regulatory Risks

Market & Financial Risks:

• Continued Losses & Financing Needs: Akebia Therapeutics, Inc. has incurred significant losses, including a net loss of $5.3 million for 2025 and an accumulated deficit of $1.7 billion. The company anticipates continued losses and requires substantial additional financing, which could lead to dilution for existing stockholders.
• Stock Price Volatility & Delisting: The company's stock price has been and may remain volatile due to various factors, including clinical trial results, regulatory developments, competition, and financial performance. Failure to comply with Nasdaq's continued listing requirements (e.g., minimum bid price) could result in delisting, negatively impacting liquidity and capital raising.
• NOL Limitations: Akebia Therapeutics, Inc.'s ability to use net operating losses (NOLs) to offset future taxable income is subject to limitations under IRC Section 382, which could increase future tax liability.

Regulatory & Compliance Risks:

• Product Approval & Label Expansion: The clinical development process is lengthy and uncertain, and there are challenges in obtaining label expansion or marketing approval for product candidates. Akebia Therapeutics, Inc. decided not to initiate the VALOR trial for broad label expansion for Vafseo in NDD-CKD patients due to FDA feedback requiring significantly larger patient numbers, time, and cost.
• Post-Marketing Requirements: Products like Auryxia and Vafseo are subject to post-marketing regulatory requirements, including pediatric studies.
• Complex Regulatory Schemes: The company operates under complex regulatory schemes, including those related to off-label promotion, FDA disruptions, and healthcare reform.
• Misconduct Risks: Misconduct by employees, contractors, or third parties could lead to violations of FDA regulations, quality standards (GxP), healthcare fraud and abuse laws, anti-bribery laws (FCPA), trade control regulations, and privacy laws (HIPAA, GDPR), resulting in significant penalties, product withdrawal, or reputational harm.

Geopolitical & External Risks

Trade Relations & Tariffs:

• Changes in U.S. foreign trade laws, including the imposition of tariffs (e.g., reciprocal tariffs, tariffs on pharmaceutical imports, 100% tariff on branded/patented drugs), could impact Akebia Therapeutics, Inc.'s international operations and supply chain. The BIOSECURE Act also limits U.S. government procurement from certain biotechnology companies.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• HIF Biology: Akebia Therapeutics, Inc. leverages its expertise in hypoxia inducible factor (HIF) biology, exemplified by Vafseo, an oral HIF-PH inhibitor. This focus extends to early-stage pipeline assets like AKB-9090 (for CS-AKI) and AKB-10108 (for ROP).
• Rare Kidney Disease: A significant R&D focus is on mid-stage rare kidney disease assets, including praliciguat (sGC stimulator for FSGS) and AKB-097 (complement inhibitor for IgAN, C3G, LN). These programs target diseases with high unmet medical needs and no or limited FDA-approved treatments.

Innovation Pipeline:

• Praliciguat: Phase 2 clinical trial for FSGS initiated December 2025.
• AKB-097: Phase 2 basket study for IgAN, C3G, LN expected to initiate in the second half of 2026, with initial data expected in 2027.
• AKB-9090: Phase 1 study in healthy volunteers expected to initiate in the first half of 2026 for CS-AKI.
• AKB-10108: Preclinical development for ROP.

Intellectual Property Portfolio:

• Patent Strategy: Akebia Therapeutics, Inc. holds a portfolio of patents for its commercial products and pipeline candidates.
  • Vafseo: 19 issued U.S. patents covering composition, polymorph, method of treating anemia, pharmaceutical compositions, and manufacturing processes, with expirations between 2027 and 2039 (plus extensions). Additional patents/applications expire between 2032 and 2042. Vafseo was granted 5-year New Chemical Entity (NCE) exclusivity in March 2024. Patent term extension applications have been filed for several U.S. patents. Japanese patents expire between 2032 and 2035. An opposition proceeding is ongoing in the Indian Patent Office.
  • Auryxia: 3 issued patents listed in the Orange Book covering composition, method of treating hyperphosphatemia, and pharmaceutical compositions, expiring between 2026 and 2030. Japanese sublicense patents expire between 2026 and 2028. European sublicense patents expire between 2026 and 2042. Akebia Therapeutics, Inc. settled patent infringement lawsuits with six ANDA filers, granting licenses to market generic Auryxia in the U.S. from March 20, 2025.
• Other IP: The company also relies on trademarks, trade secrets, and know-how to protect its innovations.

Technology Partnerships:

• Cyclerion Therapeutics, Inc.: Exclusive global license for praliciguat, involving upfront payments, development and regulatory milestones, and tiered royalties.
• Q32 Bio Inc. and Q32 Bio Operations Inc.: Asset purchase agreement for AKB-097, including upfront payments, development and commercial milestones, and tiered royalties.
• Medice, Tanabe Pharma Corporation, Averoa, JT and Torii: Licensing and collaboration agreements for the development and commercialization of Vafseo and Auryxia in various international territories.

Leadership & Governance

Board Composition: The Board of Directors oversees cybersecurity risk, delegating responsibility to the Audit Committee. The Audit Committee reports to the Board at least annually and is notified of significant threats/incidents. The Audit Committee meets annually with management and the internal cybersecurity team, and management provides quarterly updates on cybersecurity risk management.

Human Capital Strategy

Workforce Composition:

• Total Employees: As of December 31, 2025, Akebia Therapeutics, Inc. had 194 employees. No employees are represented by a collective bargaining unit.

Environmental & Social Impact

Environmental Commitments:

• Akebia Therapeutics, Inc.'s Cambridge office has achieved Fitwel Certification (level two certified), indicating a commitment to promoting occupant health and well-being through building design and operations.

Social Impact Initiatives:

• In 2025, Akebia Therapeutics, Inc. offered copay assistance to approximately 1,600 Auryxia patients, demonstrating a commitment to patient access and support.

Regulatory Environment & Compliance

Regulatory Framework: Industry-Specific Regulations:

• Akebia Therapeutics, Inc. operates under a complex regulatory framework governed by agencies such as the U.S. FDA and international equivalents. This includes regulations related to clinical trial conduct (e.g., clinicaltrials.gov registration, diversity action plans for Phase 3 studies), product approvals, post-marketing requirements (e.g., pediatric studies), and manufacturing quality standards (GxP).
• The FDA Modernization Act 2.0 (December 2022) eliminated animal testing requirements for NDAs, and the FDA has issued guidance on patient-focused drug development and Good Clinical Practices (GCPs).
• The Prescription Drug User Fee Act (PDUFA) imposes significant application and annual program fees.
• In the EU, the Clinical Trials Regulation (EU) No 536/2014 became effective in January 2022, and the EMA launched the PRIority MEdicines (PRIME) scheme.
• EU data exclusivity is 8 years data exclusivity and 10 years market exclusivity, extendable to 11 years, though provisional political agreement in December 2025 proposes changes.
• The UK's MHRA has adopted amendments to its clinical trials regime and participates in the Access Consortium for work-sharing.

Trade & Export Controls:

• Akebia Therapeutics, Inc. is subject to import and export laws and regulations, trade control regulations, and trade sanction laws. Recent U.S. trade policies, including reciprocal tariffs and potential tariffs on pharmaceutical imports, could impact international operations. The BIOSECURE Act (December 2025) limits U.S. government procurement from certain biotechnology companies.

Legal Proceedings:

• Indian Patent Opposition: Dr. Reddy’s Laboratories Limited filed an opposition to Akebia Therapeutics, Inc.'s Indian Patent No. 287720 (vadadustat composition of matter) in September 2018. An oral hearing was held in December 2025.
• European Patent Opposition: Sandoz AG filed an opposition against Akebia Therapeutics, Inc.'s European Patent No. 3007695 (vadadustat once daily dosing) in November 2024, but subsequently withdrew the opposition in December 2025, leading to the discontinuation of proceedings by the European Patent Office in January 2026.

Tax Strategy & Considerations

Tax Profile:

• Akebia Therapeutics, Inc.'s ability to use net operating losses (NOLs) to offset future taxable income is subject to limitations under IRC Section 382. An ownership change occurred on December 12, 2018, due to the merger with Keryx Biopharmaceuticals, Inc. NOLs arising in taxable years beginning after December 31, 2017, are limited to 80% of current-year taxable income. Future ownership changes or a lack of U.S. taxable income could further limit NOL utilization, increasing future tax liability.

Insurance & Risk Transfer

Risk Management Framework:

• Insurance Coverage: Akebia Therapeutics, Inc. carries product liability insurance, which it believes to be appropriate for its operations. However, claims could exceed coverage limits or fall under policy exclusions, potentially leading to material losses.