Akebia Therapeutics (AKBA) risk factors, FY2025 10-K

Akebia Therapeutics's FY2025 10-K, filed Feb 26, 2026, lists 109 risk factors in 10 groups. Against the prior year's 99: 21 new, 11 dropped, 69 substantially reworded.

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Risk factors listed
10910 groups
New this year
21vs 99 last year
Dropped
11since the prior 10-K
Substantially reworded
69of those kept
Section length
59k wordsItem 1A

What the changes say

  • Akebia faces financing and Going Concern risks tied to Vafseo revenue projections and cash reserves.
  • Manufacturing and supply dependencies on third parties and sole source China facilities threaten commercialization.
  • Tariffs and regulatory actions create trade uncertainty and increase compliance costs for products like Auryxia.

What changed since the prior 10-K

New

  • NewRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    We may need to obtain substantial additional financing to fund our business. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our R&D programs and/or commercialization efforts

    We may need substantial additional financing and if we fail to raise capital, our R&D and commercialization efforts for Vafseo and Auryxia will suffer.

  • NewRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    We may not be successful in our efforts to identify, acquire, in-license, discover, develop and commercialize additional products or product candidates or our decisions to prioritize the development of certain product candidates over others may not be successful, which could impair our ability to grow

    We acquired the clinical-stage candidate AKB-097 for rare kidney diseases, but developing and acquiring new products requires extensive resources.

  • NewRisks Related to Commercialization

    have product candidates in various stages of preclinical or clinical development to treat diseases and complications of the diseases for which we are marketing Auryxia

    Vafseo faces established and new competing anemia therapies from major companies like Amgen, Johnson & Johnson, and Roche.

  • NewRisks Related to Commercialization

    There are three FDA-approved therapies for LN: BENLYSTA (belimumab, GSK), LUPKYNIS® (voclosporin, Aurinia Pharmaceuticals) and GAZYVA (obinutuzumab, Genentech/Biogen). Novartis also is developing ianalumab in Phase 3 and complement inhibitor FABHALTA (iptacopan, Factor B inhibitor) in Phase 2

    Treating lupus nephritis involves competing against FDA-approved therapies such as Benlysta, Lupkynis, and Gazyva, along with pipeline drugs.

  • NewRisks Related to Regulatory Approval

    We may not be able to obtain orphan drug exclusivity for praliciguat or any potential future product candidates that we may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products

    We may fail to secure orphan drug exclusivity for praliciguat, allowing the FDA or EMA to approve competing products.

  • NewRisks Related to Governmental Regulation and Compliance

    digital campaigns, including social media activities, are not in compliance with fair balance requirements and anticipated rule changes at the FDA and possibly other agencies

    Digital marketing campaigns and social media activities may violate federal Anti-Kickback Statute and False Claims Act rules regarding fair balance.

  • NewRisks Related to our Reliance on Third Parties

    With respect to Vafseo, we entered into a collaboration agreement with TPC to develop and commercialize Vafseo in Japan and certain other Asian countries. Furthermore, we granted Medice an exclusive license to develop and commercialize Vafseo for the treatment of anemia in patients with CKD in the Medice Territory

    Collaborators like Otsuka and Medice have previously terminated agreements or delayed launches, harming Vafseo's commercialization.

  • NewRisks Related to our Reliance on Third Parties

    supply us on a timely basis, or at all, or their failure to successfully carry out their contractual duties or comply with regulatory requirements, cGMP requirements or guidance could cause delays in or disruptions to our supply chain and substantially harm our business

    We rely entirely on third-party manufacturers and distributors like Cardinal Health for Auryxia and Vafseo supply.

  • NewRisks Related to our Reliance on Third Parties

    Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our AKB-097 development program or other product candidates

    Manufacturing biologics like AKB-097 is complex and subject to raw material shortages, contamination, and CDMO constraints.

  • NewRisks Related to our Reliance on Third Parties

    Changes in and uncertainty surrounding U.S. trade policy on tariffs could have a material adverse impact on our business, financial condition and results of operations

    U.S. tariff actions and reciprocal trade policies in 2025 introduced trade tensions and retaliatory measures.

  • NewRisks Related to our Reliance on Third Parties

    A host of other U.S. tariff actions remain possible, including an additional 25% tariff on products from countries that do business with Iran

    Supreme Court rulings invalidated certain tariffs, but trade uncertainty persists since all Vafseo drug substance is manufactured in China.

  • NewRisks Related to our Intellectual Property

    Akebia Therapeutics, Inc. | Form 10-K | Page 105

    Competitors may assert patent infringement claims against our commercial products, Auryxia and Vafseo, citing patents held by FibroGen.

  • NewRisks Related to our Intellectual Property

    Akebia Therapeutics, Inc. | Form 10-K | Page 106

  • NewRisks Related to our Business and Managing Growth

    Although we have determined that the previously identified material weakness has been remediated as of December 31, 2025, we cannot assure you that we will not identify other material weaknesses in the future, which could negatively impact our results of operations in future periods

  • NewRisks Related to our Business and Managing Growth

    Akebia Therapeutics, Inc. | Form 10-K | Page 108

  • NewRisks Related to our Business and Managing Growth

    Akebia Therapeutics, Inc. | Form 10-K | Page 109

  • NewRisks Related to our Business and Managing Growth

    Akebia Therapeutics, Inc. | Form 10-K | Page 110

  • NewRisks Related to our Business and Managing Growth

    Akebia Therapeutics, Inc. | Form 10-K | Page 111

  • NewRisks Related to our Business and Managing Growth

    Akebia Therapeutics, Inc. | Form 10-K | Page 112

  • NewRisks Related to our Business and Managing Growth

    Akebia Therapeutics, Inc. | Form 10-K | Page 113

  • NewRisks Related to our Common Stock

    Akebia Therapeutics, Inc. | Form 10-K | Page 115

Dropped

  • DroppedRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Although we continue to focus a substantial amount of our efforts to develop and commercialize Auryxia and Vafseo, a key element of our long-term growth strategy is to develop additional product candidates and acquire, in-license, develop and/or market additional products and product candidates

  • DroppedRisks Related to our Financial Arrangements

    could result in enforcement action, including acceleration of amounts due under the BlackRock Credit Agreement, or limit our ability to make certain payments under the Vifor Termination Agreement

  • DroppedRisks Related to Commercialization

    adequately reimburse the dialysis facilities for Auryxia or Vafseo at a price that allows us to continue to sell Auryxia or Vafseo at a profit

  • DroppedRisks Related to Regulatory Approval

    market, and we may be subject to penalties, including withdrawal of marketing approval, if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, or product candidates, when and if approved

  • DroppedRisks Related to Governmental Regulation and Compliance

    We will incur significant liability if it is determined that we are promoting any “off-label” use of Auryxia, Vafseo or any other product we may develop, in-license or acquire or if it is determined that any of our activities violates the federal Anti-Kickback Statute

  • DroppedRisks Related to our Reliance on Third Parties

    collaborations, we may not be able to capitalize on the market potential of our products or product candidates, and our business could be materially harmed

  • DroppedRisks Related to our Reliance on Third Parties

    other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, divert management’s attention, or disrupt our business

  • DroppedRisks Related to our Reliance on Third Parties

    License Agreement in the future. In addition, if Panion breaches its agreement with the inventor from whom it licenses rights to Auryxia, Panion could lose its license, which could impair or delay our ability to develop and commercialize Auryxia

  • DroppedRisks Related to our Intellectual Property

    In addition, patents protecting our product candidate might expire before or shortly after such candidate is commercialized. Thus, our patent portfolio may not provide sufficient rights to exclude others from commercializing products similar or identical to ours

    Research programs may fail to yield clinical candidates due to unsuccessful methodologies.

  • DroppedRisks Related to our Business and Managing Growth

    In addition, our conclusion that we have a material weakness could give rise to increased scrutiny, review, audit and investigation over our accounting controls and procedures, which could then lead to additional areas of deficiency or errors in our financial statements

  • DroppedRisks Related to our Business and Managing Growth

    conditions. Any potential future impairment of property and equipment, our right-of-use assets or goodwill may significantly impact our results of operations and financial condition

Reworded

  • 100% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Akebia Therapeutics, Inc. | Form 10-K | Page 53

    Expanded from general candidate discovery risks to specific details regarding Auryxia generic timing post-LoE in March 2025 and GMP supply.

  • 100% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Akebia Therapeutics, Inc. | Form 10-K | Page 54

    Replaced generic M&A integration risks with specific financial terms for the AKB-097 asset purchase agreement totaling up to $487.5M in milestones.

  • 100% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Akebia Therapeutics, Inc. | Form 10-K | Page 59

    Replaced prior accumulated loss and BlackRock credit terms with detailed acquisition risks like integration failure, amortization, and due diligence gaps.

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 50

  • 100% rewrittenRisks Related to our Financial Arrangements

    Akebia Therapeutics, Inc. | Form 10-K | Page 60

    Replaced dialysis reimbursement risks with restrictive covenants under the credit agreement limiting assets, debt, dividends, and business flexibility.

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 61

    Replaced specific competitor drug mentions with protocol adoption hurdles for Vafseo by dialysis organizations, noting slower 2025 physician uptake.

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 62

    Replaced competitor resource comparisons with factors governing net product revenue, including publicity, commercial expenses, and uncontrollable costs.

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 63

    Replaced foreign currency exchange rate fluctuation details with specific payor criteria for coverage and reimbursement of Auryxia and Vafseo.

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 64

    Replaced clinical trial delay factors with state Medicaid and third-party payor discount, rebate, and formulary contracting risks.

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 65

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 67

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 51

  • 100% rewrittenRisks Related to Product Development

    Akebia Therapeutics, Inc. | Form 10-K | Page 74

  • 100% rewrittenRisks Related to Regulatory Approval

    Akebia Therapeutics, Inc. | Form 10-K | Page 77

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 88

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 89

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 83

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 92

  • 100% rewrittenRisks Related to our Reliance on Third Parties

    Akebia Therapeutics, Inc. | Form 10-K | Page 97

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 94

  • 100% rewrittenRisks Related to our Reliance on Third Parties

    Akebia Therapeutics, Inc. | Form 10-K | Page 98

  • 100% rewrittenRisks Related to our Reliance on Third Parties

    Akebia Therapeutics, Inc. | Form 10-K | Page 99

  • 100% rewrittenRisks Related to our Reliance on Third Parties

    Akebia Therapeutics, Inc. | Form 10-K | Page 100

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 95

  • 100% rewrittenRisks Related to our Intellectual Property

    Akebia Therapeutics, Inc. | Form 10-K | Page 102

  • 100% rewrittenRisks Related to our Intellectual Property

    Akebia Therapeutics, Inc. | Form 10-K | Page 103

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 82

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 84

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 71

  • 100% rewrittenRisks Related to Commercialization

    Akebia Therapeutics, Inc. | Form 10-K | Page 68

  • 100% rewrittenRisks Related to Regulatory Approval

    Akebia Therapeutics, Inc. | Form 10-K | Page 75

  • 100% rewrittenRisks Related to our Reliance on Third Parties

    Akebia Therapeutics, Inc. | Form 10-K | Page 93

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 86

  • 100% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Akebia Therapeutics, Inc. | Form 10-K | Page 58

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 90

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 81

  • 100% rewrittenRisks Related to our Intellectual Property

    Akebia Therapeutics, Inc. | Form 10-K | Page 101

  • 100% rewrittenRisks Related to Regulatory Approval

    Akebia Therapeutics, Inc. | Form 10-K | Page 78

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 56

  • 100% rewrittenRisks Related to Product Development

    Akebia Therapeutics, Inc. | Form 10-K | Page 72

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 52

  • 100% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Akebia Therapeutics, Inc. | Form 10-K | Page 57

  • 100% rewrittenRisks Related to Regulatory Approval

    Akebia Therapeutics, Inc. | Form 10-K | Page 79

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 66

  • 100% rewrittenRisks Related to Regulatory Approval

    Akebia Therapeutics, Inc. | Form 10-K | Page 76

  • 100% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 85

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 73

  • 100% rewrittenRisks Related to Regulatory Approval

    Akebia Therapeutics, Inc. | Form 10-K | Page 80

  • 100% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Akebia Therapeutics, Inc. | Form 10-K | Page 55

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 49

  • 99% rewrittenRisks Related to Product Development

    Akebia Therapeutics, Inc. | Form 10-K | Page 70

  • 98% rewrittenRisks Related to Governmental Regulation and Compliance

    Akebia Therapeutics, Inc. | Form 10-K | Page 91

  • 95% rewrittenRisks Related to our Intellectual Property

    In addition, any limitations of our patent protection described above may adversely affect the value of our drug product and may inhibit our ability to obtain a collaboration partner at terms acceptable to us, if at all

  • 95% rewrittenRisks Related to our Reliance on Third Parties

    Changes in the geopolitical environment, including U.S. and international trade policies, particularly with respect to China, Europe or Canada, may adversely impact our business and operating results

    Was: Changes in U.S. and international trade policies, particularly with respect to China or Canada, may adversely impact our business and operating results

  • 94% rewrittenRisks Related to Governmental Regulation and Compliance

    Our reporting and payment obligations under the Medicaid Drug Rebate Program, Medicare and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to properly comply with those obligations could subject us to penalties and sanctions

  • 89% rewrittenRisks Related to Product Development

    Akebia Therapeutics, Inc. | Form 10-K | Page 69

  • 89% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    We have expended and may in the future expend significant resources on our legal proceedings, as described below under Part I, Item 3. Legal Proceedings, including any legal proceedings that may be brought by or against us in the future

  • 88% rewrittenRisks Related to our Reliance on Third Parties

    We may seek to establish additional collaborations and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans

  • 86% rewrittenRisks Related to our Reliance on Third Parties

    If the licensor of certain intellectual property relating to Auryxia terminates, modifies or threatens to terminate existing contracts or relationships with us, our business may be materially harmed

  • 80% rewrittenRisks Related to our Intellectual Property

    If we are unable to adequately protect our intellectual property, third parties may be able to use our intellectual property, which could adversely affect our ability to compete in the market

  • 76% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    If any of these events occur, we may be forced to abandon our R&D efforts for one or more of our programs, or we may not be able to identify, discover, develop or commercialize additional product candidates, including those that may be in-licensed or acquired, which may have a material adverse effect on our business

  • 73% rewrittenRisks Related to Commercialization

    Our business is substantially dependent on the commercial success of Auryxia and Vafseo. If we are unable to continue to successfully commercialize Auryxia and Vafseo, our results of operations and financial condition will be materially harmed

  • 69% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our products and product candidates on unfavorable terms to us

  • 65% rewrittenRisks Related to our Financial Arrangements

    Our obligations in connection with the BlackRock Credit Agreement and requirements and restrictions in the BlackRock Credit Agreement could adversely affect our financial condition and restrict our operations

  • 63% rewrittenRisks Related to Commercialization

    We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do

  • 60% rewrittenRisks Related to Commercialization

    If we are unable to maintain sales and marketing capabilities or enter into or maintain agreements with third parties, we may not be successful in commercializing Auryxia, Vafseo or any other product candidates that may be approved

    Was: If we are unable to maintain or expand sales and marketing capabilities or enter into additional agreements with third parties, we may not be successful in commercializing Auryxia, Vafseo or any other product candidates that may be approved

  • 60% rewrittenRisks Related to Product Development

    Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and we will incur additional costs in connection with, and may experience delays in completing, or ultimately be unable to complete, the development of any of our product candidates

  • 58% rewrittenRisks Related to our Business and Managing Growth

    consultants, vendors, suppliers and other third parties. These relationships are complex and create numerous risks as we deal with issues that arise

    Was: we expect that we will need to manage our current relationships and enter into new relationships with various strategic collaborators, consultants, vendors, suppliers and other third parties. These relationships are complex and create numerous risks as we deal with issues that arise

  • 54% rewrittenRisks Related to our Reliance on Third Parties

    Akebia Therapeutics, Inc. | Form 10-K | Page 96

    Was: Akebia Therapeutics, Inc. | Form 10-K | Page 87

  • 53% rewrittenRisks Related to our Reliance on Third Parties

    Royalties from commercial sales of Vafseo under our TPC Agreement will likely fluctuate and will impact our rights to receive future payments under our Royalty Agreement with HCR

    Was: Royalties from commercial sales of Vafseo under our MTPC Agreement will likely fluctuate and will impact our rights to receive future payments under our Royalty Agreement with HCR

  • 47% rewrittenRisks Related to our Intellectual Property

    The market entry of one or more generic competitors or any third party’s attempt to challenge our intellectual property rights will likely limit Auryxia and Vafseo sales and have an adverse impact on our business and results of operation

  • 45% rewrittenRisks Related to Product Development

    We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired

  • 44% rewrittenRisks Related to our Common Stock

    Our stock price has been and may continue to be volatile, which could result in substantial losses for holders or future purchasers of our common stock and lawsuits against us and our officers and directors and could result in substantial costs and divert management's attention

  • 43% rewrittenRisks Related to Regulatory Approval

    If we are unable to obtain or maintain marketing approval in jurisdictions outside the United States, we and our partners will not be able to market any of our products or product candidates outside of the United States

    Was: If we are unable to obtain or maintain marketing approval in jurisdictions outside the United States, we and our partners will not be able to market any product or product candidates outside of the United States

  • 43% rewrittenRisks Related to our Business and Managing Growth

    Our ability to use net operating losses to offset future taxable income may be subject to certain limitations

  • 40% rewrittenRisks Related to our Business and Managing Growth

    We may encounter difficulties in managing our growth, including with respect to our employee base, and managing our partnerships and operations successfully

  • 36% rewrittenRisks Related to our Common Stock

    The issuance of additional shares of our common stock or the sale of shares of our common stock by any of our directors, officers or significant stockholders will dilute our stockholders’ ownership interest in Akebia and may cause the market price of our common stock to decline

  • 35% rewrittenRisks Related to our Business and Managing Growth

    If we fail to attract, retain and motivate senior management and qualified personnel, we may be unable to successfully develop and commercialize Auryxia, Vafseo or any of our product candidates

  • 35% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    We have incurred significant losses since our inception, and anticipate that we will continue to incur losses and cannot guarantee when, if ever, we will become and remain profitable

    Was: We have incurred significant losses since our inception, and anticipate that we will continue to incur losses and cannot guarantee when, if ever, we will become profitable or attain positive cash flows

  • 31% rewrittenRisks Related to our Financial Position, Need for Additional Capital and Growth Strategy

    We may require substantial additional financing to fund our business. A failure to obtain this necessary capital when needed, or on acceptable terms, could force us to delay, limit, reduce or terminate our product development or commercialization efforts

  • 21% rewrittenRisks Related to our Financial Arrangements

    Our Royalty Interest Acquisition Agreement with HealthCare Royalty Partners IV, L.P. contains various covenants and other provisions, which, if violated, could materially adversely affect our financial condition

All 109 risk factors

Headings as the filing states them, in filing order.

Risks Related to our Financial Position, Need for Additional Capital and Growth Strategy

  1. 01We have incurred significant losses since our inception, and anticipate that we will continue to incur losses and cannot guarantee when, if ever, we will become and remain profitable35% rewritten
  2. 02Akebia Therapeutics, Inc. | Form 10-K | Page 53100% rewritten
  3. 03Akebia Therapeutics, Inc. | Form 10-K | Page 54100% rewritten
  4. 04We have expended and may in the future expend significant resources on our legal proceedings, as described below under Part I, Item 3. Legal Proceedings, including any legal proceedings that may be brought by or against us in the future89% rewritten
  5. 05Akebia Therapeutics, Inc. | Form 10-K | Page 55100% rewritten
  6. 06We may require substantial additional financing to fund our business. A failure to obtain this necessary capital when needed, or on acceptable terms, could force us to delay, limit, reduce or terminate our product development or commercialization efforts31% rewritten
  7. 07We may need to obtain substantial additional financing to fund our business. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our R&D programs and/or commercialization effortsNew
  8. 08Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our products and product candidates on unfavorable terms to us69% rewritten
  9. 09Akebia Therapeutics, Inc. | Form 10-K | Page 57100% rewritten
  10. 10We may not be successful in our efforts to identify, acquire, in-license, discover, develop and commercialize additional products or product candidates or our decisions to prioritize the development of certain product candidates over others may not be successful, which could impair our ability to growNew
  11. 11If any of these events occur, we may be forced to abandon our R&D efforts for one or more of our programs, or we may not be able to identify, discover, develop or commercialize additional product candidates, including those that may be in-licensed or acquired, which may have a material adverse effect on our business76% rewritten
  12. 12Akebia Therapeutics, Inc. | Form 10-K | Page 58100% rewritten
  13. 13Akebia Therapeutics, Inc. | Form 10-K | Page 59100% rewritten

Risks Related to our Financial Arrangements

  1. 14Our obligations in connection with the BlackRock Credit Agreement and requirements and restrictions in the BlackRock Credit Agreement could adversely affect our financial condition and restrict our operations65% rewritten
  2. 15Akebia Therapeutics, Inc. | Form 10-K | Page 60100% rewritten
  3. 16Our Royalty Interest Acquisition Agreement with HealthCare Royalty Partners IV, L.P. contains various covenants and other provisions, which, if violated, could materially adversely affect our financial condition21% rewritten

Risks Related to Commercialization

  1. 17Our business is substantially dependent on the commercial success of Auryxia and Vafseo. If we are unable to continue to successfully commercialize Auryxia and Vafseo, our results of operations and financial condition will be materially harmed73% rewritten
  2. 18Akebia Therapeutics, Inc. | Form 10-K | Page 61100% rewritten
  3. 19Akebia Therapeutics, Inc. | Form 10-K | Page 62100% rewritten
  4. 20If we are unable to maintain sales and marketing capabilities or enter into or maintain agreements with third parties, we may not be successful in commercializing Auryxia, Vafseo or any other product candidates that may be approved60% rewritten
  5. 21Akebia Therapeutics, Inc. | Form 10-K | Page 63100% rewritten
  6. 22Akebia Therapeutics, Inc. | Form 10-K | Page 64100% rewritten
  7. 23Akebia Therapeutics, Inc. | Form 10-K | Page 65100% rewritten
  8. 24We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do63% rewritten
  9. 25have product candidates in various stages of preclinical or clinical development to treat diseases and complications of the diseases for which we are marketing AuryxiaNew
  10. 26Akebia Therapeutics, Inc. | Form 10-K | Page 67100% rewritten
  11. 27There are three FDA-approved therapies for LN: BENLYSTA (belimumab, GSK), LUPKYNIS® (voclosporin, Aurinia Pharmaceuticals) and GAZYVA (obinutuzumab, Genentech/Biogen). Novartis also is developing ianalumab in Phase 3 and complement inhibitor FABHALTA (iptacopan, Factor B inhibitor) in Phase 2New
  12. 28Akebia Therapeutics, Inc. | Form 10-K | Page 68100% rewritten

Risks Related to Product Development

  1. 29Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and we will incur additional costs in connection with, and may experience delays in completing, or ultimately be unable to complete, the development of any of our product candidates60% rewritten
  2. 30Akebia Therapeutics, Inc. | Form 10-K | Page 6989% rewritten
  3. 31Akebia Therapeutics, Inc. | Form 10-K | Page 7099% rewritten
  4. 32We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired45% rewritten
  5. 33Akebia Therapeutics, Inc. | Form 10-K | Page 72100% rewritten
  6. 34Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired, may cause undesirable side effects or have other properties that may delay or prevent marketing approval or limit their commercial potential
  7. 35Akebia Therapeutics, Inc. | Form 10-K | Page 74100% rewritten

Risks Related to Regulatory Approval

  1. 36We may not be able to obtain marketing approval for any potential label expansion for Vafseo or any current or future product candidate, or we may experience significant delays in doing so, any of which would materially harm our business
  2. 37Akebia Therapeutics, Inc. | Form 10-K | Page 75100% rewritten
  3. 38Akebia Therapeutics, Inc. | Form 10-K | Page 76100% rewritten
  4. 39Akebia Therapeutics, Inc. | Form 10-K | Page 77100% rewritten
  5. 40We may not be able to obtain orphan drug exclusivity for praliciguat or any potential future product candidates that we may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing productsNew
  6. 41Akebia Therapeutics, Inc. | Form 10-K | Page 78100% rewritten
  7. 42If we are unable to obtain or maintain marketing approval in jurisdictions outside the United States, we and our partners will not be able to market any of our products or product candidates outside of the United States43% rewritten
  8. 43Akebia Therapeutics, Inc. | Form 10-K | Page 79100% rewritten
  9. 44Akebia Therapeutics, Inc. | Form 10-K | Page 80100% rewritten
  10. 45Non-compliance with the FDA, the EMA, the PMDA and other regulatory authorities’ requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties

Risks Related to Governmental Regulation and Compliance

  1. 46Akebia Therapeutics, Inc. | Form 10-K | Page 81100% rewritten
  2. 47Akebia Therapeutics, Inc. | Form 10-K | Page 82100% rewritten
  3. 48digital campaigns, including social media activities, are not in compliance with fair balance requirements and anticipated rule changes at the FDA and possibly other agenciesNew
  4. 49Akebia Therapeutics, Inc. | Form 10-K | Page 84100% rewritten
  5. 50Akebia Therapeutics, Inc. | Form 10-K | Page 85100% rewritten
  6. 51to ensure that our policies recognize the rights granted to consumers (as that phrase is broadly defined in the CCPA and can include business contact information)
  7. 52Legislative and regulatory healthcare reform may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain for any products that are approved in the U.S. or foreign jurisdictions
  8. 53Akebia Therapeutics, Inc. | Form 10-K | Page 88100% rewritten
  9. 54Akebia Therapeutics, Inc. | Form 10-K | Page 89100% rewritten
  10. 55Akebia Therapeutics, Inc. | Form 10-K | Page 90100% rewritten
  11. 56Akebia Therapeutics, Inc. | Form 10-K | Page 9198% rewritten
  12. 57Our reporting and payment obligations under the Medicaid Drug Rebate Program, Medicare and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to properly comply with those obligations could subject us to penalties and sanctions94% rewritten
  13. 58Akebia Therapeutics, Inc. | Form 10-K | Page 92100% rewritten
  14. 59If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business

Risks Related to our Reliance on Third Parties

  1. 60Akebia Therapeutics, Inc. | Form 10-K | Page 93100% rewritten
  2. 61With respect to Vafseo, we entered into a collaboration agreement with TPC to develop and commercialize Vafseo in Japan and certain other Asian countries. Furthermore, we granted Medice an exclusive license to develop and commercialize Vafseo for the treatment of anemia in patients with CKD in the Medice TerritoryNew
  3. 62We may seek to establish additional collaborations and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans88% rewritten
  4. 63Royalties from commercial sales of Vafseo under our TPC Agreement will likely fluctuate and will impact our rights to receive future payments under our Royalty Agreement with HCR53% rewritten
  5. 64supply us on a timely basis, or at all, or their failure to successfully carry out their contractual duties or comply with regulatory requirements, cGMP requirements or guidance could cause delays in or disruptions to our supply chain and substantially harm our businessNew
  6. 65Akebia Therapeutics, Inc. | Form 10-K | Page 9654% rewritten
  7. 66Akebia Therapeutics, Inc. | Form 10-K | Page 97100% rewritten
  8. 67If the third parties upon whom we rely to conduct our trials fail to adhere to clinical trial protocols or to regulatory requirements, the quantity, quality or accuracy of the data obtained by the third parties may be compromised. We are exposed to the risk of fraud or other misconduct by such third parties
  9. 68If the licensor of certain intellectual property relating to Auryxia terminates, modifies or threatens to terminate existing contracts or relationships with us, our business may be materially harmed86% rewritten
  10. 69Akebia Therapeutics, Inc. | Form 10-K | Page 98100% rewritten
  11. 70Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our AKB-097 development program or other product candidatesNew
  12. 71Akebia Therapeutics, Inc. | Form 10-K | Page 99100% rewritten
  13. 72Changes in and uncertainty surrounding U.S. trade policy on tariffs could have a material adverse impact on our business, financial condition and results of operationsNew
  14. 73A host of other U.S. tariff actions remain possible, including an additional 25% tariff on products from countries that do business with IranNew
  15. 74Changes in the geopolitical environment, including U.S. and international trade policies, particularly with respect to China, Europe or Canada, may adversely impact our business and operating results95% rewritten
  16. 75Akebia Therapeutics, Inc. | Form 10-K | Page 100100% rewritten

Risks Related to our Intellectual Property

  1. 76If we are unable to adequately protect our intellectual property, third parties may be able to use our intellectual property, which could adversely affect our ability to compete in the market80% rewritten
  2. 77Akebia Therapeutics, Inc. | Form 10-K | Page 101100% rewritten
  3. 78Akebia Therapeutics, Inc. | Form 10-K | Page 102100% rewritten
  4. 79We may not be able to protect our intellectual property rights throughout the world
  5. 80The intellectual property that we own or have licensed and related non-patent exclusivity relating to our current and future products is, and may be, limited, which could adversely affect our ability to compete in the market and adversely affect the value of Auryxia, Vafseo or other future products
  6. 81In addition, any limitations of our patent protection described above may adversely affect the value of our drug product and may inhibit our ability to obtain a collaboration partner at terms acceptable to us, if at all95% rewritten
  7. 82Akebia Therapeutics, Inc. | Form 10-K | Page 103100% rewritten
  8. 83The market entry of one or more generic competitors or any third party’s attempt to challenge our intellectual property rights will likely limit Auryxia and Vafseo sales and have an adverse impact on our business and results of operation47% rewritten
  9. 84Litigation and administrative proceedings, including third party claims of intellectual property infringement and opposition/invalidation proceedings against third party patents, may be costly and time consuming and may delay or harm our drug discovery, development and commercialization efforts
  10. 85Akebia Therapeutics, Inc. | Form 10-K | Page 105New
  11. 86Akebia Therapeutics, Inc. | Form 10-K | Page 106New
  12. 87We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties

Risks Related to our Business and Managing Growth

  1. 88If we fail to attract, retain and motivate senior management and qualified personnel, we may be unable to successfully develop and commercialize Auryxia, Vafseo or any of our product candidates35% rewritten
  2. 89We may encounter difficulties in managing our growth, including with respect to our employee base, and managing our partnerships and operations successfully40% rewritten
  3. 90consultants, vendors, suppliers and other third parties. These relationships are complex and create numerous risks as we deal with issues that arise58% rewritten
  4. 91Although we have determined that the previously identified material weakness has been remediated as of December 31, 2025, we cannot assure you that we will not identify other material weaknesses in the future, which could negatively impact our results of operations in future periodsNew
  5. 92Akebia Therapeutics, Inc. | Form 10-K | Page 108New
  6. 93Akebia Therapeutics, Inc. | Form 10-K | Page 109New
  7. 94Akebia Therapeutics, Inc. | Form 10-K | Page 110New
  8. 95Akebia Therapeutics, Inc. | Form 10-K | Page 111New
  9. 96If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of Auryxia or Vafseo or affect the development of our product candidates
  10. 97Akebia Therapeutics, Inc. | Form 10-K | Page 112New
  11. 98We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to compliance initiatives and corporate governance practices
  12. 99Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us
  13. 100Our ability to use net operating losses to offset future taxable income may be subject to certain limitations43% rewritten
  14. 101Akebia Therapeutics, Inc. | Form 10-K | Page 113New

Risks Related to our Common Stock

  1. 102Our stock price has been and may continue to be volatile, which could result in substantial losses for holders or future purchasers of our common stock and lawsuits against us and our officers and directors and could result in substantial costs and divert management's attention44% rewritten
  2. 103If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
  3. 104The issuance of additional shares of our common stock or the sale of shares of our common stock by any of our directors, officers or significant stockholders will dilute our stockholders’ ownership interest in Akebia and may cause the market price of our common stock to decline36% rewritten
  4. 105Akebia Therapeutics, Inc. | Form 10-K | Page 115New
  5. 106Our executive officers, directors and principal stockholders maintain the ability to significantly influence all matters submitted to stockholders for approval
  6. 107Provisions in our organizational documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management
  7. 108These provisions, alone or together, could delay or prevent hostile takeovers, changes in control or changes in our management
  8. 109Because we do not anticipate paying any cash dividends on our capital in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain

Other Akebia Therapeutics 10-Ks

  • FY2024 10-K risk factors
    99 risks

    Akebia Therapeutics faces significant financial risks centered on the ongoing commercialization and profitability of its core products, Auryxia and Vafseo. The company relies heavily on debt facilities with restrictive covenants, such as the BlackRock credit agreement, and depends on favorable reimbursement policies and successful clinical and regulatory execution.

    Filed Mar 13, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.