Akebia Therapeutics (AKBA) risk factors, FY2024 10-K

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 profitable or attain positive cash flows
2. 02Akebia Therapeutics, Inc. | Form 10-K | Page 49
3. 03Akebia Therapeutics, Inc. | Form 10-K | Page 50
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 future
5. 05Akebia Therapeutics, Inc. | Form 10-K | Page 51
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 efforts
7. 07Akebia Therapeutics, Inc. | Form 10-K | Page 52
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 us
9. 09Although 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
10. 10Akebia Therapeutics, Inc. | Form 10-K | Page 53
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 business
12. 12Akebia Therapeutics, Inc. | Form 10-K | Page 54

Risks Related to our Financial Arrangements

1. 13Our 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
2. 14could 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
3. 15Our 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

Risks Related to Commercialization

1. 16Our 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
2. 17Akebia Therapeutics, Inc. | Form 10-K | Page 56
3. 18Akebia Therapeutics, Inc. | Form 10-K | Page 57
4. 19If 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
5. 20Akebia Therapeutics, Inc. | Form 10-K | Page 58
6. 21adequately reimburse the dialysis facilities for Auryxia or Vafseo at a price that allows us to continue to sell Auryxia or Vafseo at a profit
7. 22Akebia Therapeutics, Inc. | Form 10-K | Page 60
8. 23We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do
9. 24Akebia Therapeutics, Inc. | Form 10-K | Page 61
10. 25Akebia Therapeutics, Inc. | Form 10-K | Page 62
11. 26Akebia Therapeutics, Inc. | Form 10-K | Page 63

Risks Related to Product Development

1. 27Clinical 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
2. 28Akebia Therapeutics, Inc. | Form 10-K | Page 64
3. 29Akebia Therapeutics, Inc. | Form 10-K | Page 65
4. 30We 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
5. 31Akebia Therapeutics, Inc. | Form 10-K | Page 66
6. 32Auryxia, 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. 33Akebia Therapeutics, Inc. | Form 10-K | Page 68

Risks Related to Regulatory Approval

1. 34We may not be able to obtain marketing approval for any 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. 35Akebia Therapeutics, Inc. | Form 10-K | Page 69
3. 36Akebia Therapeutics, Inc. | Form 10-K | Page 70
4. 37Akebia Therapeutics, Inc. | Form 10-K | Page 71
5. 38If 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
6. 39market, 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
7. 40Akebia Therapeutics, Inc. | Form 10-K | Page 73
8. 41Non-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. 42Akebia Therapeutics, Inc. | Form 10-K | Page 74
2. 43Akebia Therapeutics, Inc. | Form 10-K | Page 75
3. 44We 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
4. 45Akebia Therapeutics, Inc. | Form 10-K | Page 76
5. 46Akebia Therapeutics, Inc. | Form 10-K | Page 77
6. 47to 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. 48Legislative 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. 49Akebia Therapeutics, Inc. | Form 10-K | Page 80
9. 50Akebia Therapeutics, Inc. | Form 10-K | Page 81
10. 51Our 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
11. 52Akebia Therapeutics, Inc. | Form 10-K | Page 82
12. 53Akebia Therapeutics, Inc. | Form 10-K | Page 83
13. 54If 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. 55collaborations, we may not be able to capitalize on the market potential of our products or product candidates, and our business could be materially harmed
2. 56We 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
3. 57other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, divert management’s attention, or disrupt our business
4. 58Royalties 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
5. 59Akebia Therapeutics, Inc. | Form 10-K | Page 86
6. 60Akebia Therapeutics, Inc. | Form 10-K | Page 87
7. 61Akebia Therapeutics, Inc. | Form 10-K | Page 88
8. 62If 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 risk of fraud or other misconduct by such third parties
9. 63If 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
10. 64License 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
11. 65Changes in U.S. and international trade policies, particularly with respect to China or Canada, may adversely impact our business and operating results

Risks Related to our Intellectual Property

1. 66If 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
2. 67Akebia Therapeutics, Inc. | Form 10-K | Page 90
3. 68Akebia Therapeutics, Inc. | Form 10-K | Page 91
4. 69In 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
5. 70We may not be able to protect our intellectual property rights throughout the world
6. 71The 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
7. 72Akebia Therapeutics, Inc. | Form 10-K | Page 92
8. 73In 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
9. 74The 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
10. 75Litigation 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
11. 76Akebia Therapeutics, Inc. | Form 10-K | Page 94
12. 77Akebia Therapeutics, Inc. | Form 10-K | Page 95
13. 78We 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. 79If 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
2. 80We may encounter difficulties in managing our growth, including with respect to our employee base, and managing our partnerships and operations successfully
3. 81we 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
4. 82In 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
5. 83Akebia Therapeutics, Inc. | Form 10-K | Page 98
6. 84Akebia Therapeutics, Inc. | Form 10-K | Page 99
7. 85conditions. 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
8. 86If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of Auryxia or Vafseo
9. 87Akebia Therapeutics, Inc. | Form 10-K | Page 101
10. 88We 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
11. 89Claims 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
12. 90Our ability to use net operating losses to offset future taxable income may be subject to certain limitations
13. 91Akebia Therapeutics, Inc. | Form 10-K | Page 102

Risks Related to our Common Stock

1. 92Our 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
2. 93Akebia Therapeutics, Inc. | Form 10-K | Page 103
3. 94If 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
4. 95The 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
5. 96Our executive officers, directors and principal stockholders maintain the ability to significantly influence all matters submitted to stockholders for approval
6. 97Provisions 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. 98These provisions, alone or together, could delay or prevent hostile takeovers, changes in control or changes in our management
8. 99Because 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