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New words:
absent, absorption, accretion, alleviate, AmerisourceBergen, API, arbitrarily, ASP, attendant, attorney, awaiting, batch, bill, BIOSECURE, BlackRock, bore, boxed, buying, Canadian, capriciously, carefully, Ceiling, Cencora, certiorari, Chinese, clear, cloud, CMO, CODM, copy, counted, coupled, customarily, Dakota, death, deep, deferral, discharged, dose, dosing, doubtful, draft, drawdown, engineering, ESRD, Evrenzo, exhibit, explicit, fake, Florida, furnished, Hampshire, heard, Hedging, highest, holder, home, House, implicit, inaccurate, incomplete, infarction, ingredient, intolerant, invoice, job, linked, longest, Maine, Mexico, myocardial, navigate, network, nondiscriminatory, OB, overcharge, overdue, overseen, pattern, PAYGO, petition, plaintiff, plant, portal, PPS, preponderance, pretax, pro, PSU, rata, ready, reconcile, reconciling, recoverable, rejection, resale, retail, retrospectively, SCSp, seasonality, Senate, sequestration, shortage, simplifying, social, solid, South, standing, statutorily, streamlining, subpopulation, sum, Supplementary, tenor, timetable, Tricare, Trump, unbiased, unconditional, unrest, unstable, untimely, vendor, verification, Vermont, video, VII, voice, warrant, Wisconsin, writ, XPHOZAH
Removed:
adjudicated, affirmed, Aid, al, alleging, Allergy, Alpha, altitude, Amello, Amerisource, appealed, approach, approvability, approximated, bear, Bergen, binding, bowel, Butler, call, Cameron, Canute, caption, captioned, chill, Clarifying, Clayman, comparator, compelling, complaint, concentrated, conferring, consolidation, constipation, contracted, coordination, correspondingly, covenant, Cynthia, Daniel, DD, deliverable, depression, desire, discounted, Division, DMCC, Duane, eager, elimination, embedded, emergency, encouraging, engendered, Enyedy, EP, erythropoietin, escalating, escalation, estate, exacerbate, existed, exogenously, expiry, facing, free, Gilman, Gowen, guaranteed, headcount, hearing, Heffernan, heightened, hospitalized, host, Houston, hypoxemia, Iceland, influence, instrument, interact, interfere, internally, invalidation, invested, irritable, Jason, Jodie, John, jointly, JPO, Jr, jurisdictional, Kevin, landlord, Leveraging, LIBOR, licensee, Liechtenstein, lien, line, living, Loper, maintained, Mark, Maxine, Michael, mimic, mindful, mission, moderate, Morrison, motion, moved, Nash, national, NDD, nonrefundable, Norway, Ordinal, outsourced, overcome, Panicho, path, pathway, payer, penalty, people, permission, physiologic, point, power, prejudice, premature, proportion, protracted, purported, putative, randomized, real, recite, recognizing, Reddy, reducing, refractory, Regan, relate, relieved, Renaud, represented, rescission, reversed, revoked, rolling, Ronald, rural, Russia, Sandoz, satisfaction, saturation, scheduled, Science, Scott, Smith, sourcing, steering, Steven, stipulation, subordinate, substituted, thereon, tied, transferrin, unamortized, unchanged, undermined, unit, University, unnecessarily, unnecessary, unpaid, updated, USA, user, UTHealth, Vanguard, vigorously, withdraw, worsening, wrongdoing, Wyzga, York
Financial report summary
?Competition
AMGEN • Roche Holding • Astrazeneca • FibroGen • Astellas Pharma • Astellas Pharma • Pieris Pharmaceuticals • Disc MedicineRisks
- 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.
- 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.
- 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.
- If 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.
- We may engage in strategic transactions to acquire assets, businesses, or rights to products, product candidates or technologies or form collaborations or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt, or cause us to incur significant expense.
- 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.
- 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.
- Our business is substantially dependent on the commercial success of Auryxia and Vafseo. If we are unable to continue to successfully commercialize Auryxia and commercially launch Vafseo, our results of operations and financial condition will be materially harmed.
- If we are unable to maintain or expand, or, with respect to Vafseo, initiate, 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.
- We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully than, we do.
- The commercialization of Riona and Vafseo in Japan, Vafseo in Europe and other territories where it is approved, and our current and potential future efforts with respect to the development and commercialization of our products and product candidates outside of the U.S. subject us to a variety of risks associated with international operations, which could materially adversely affect our business.
- 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.
- 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.
- Conducting clinical trials outside of the U.S., as we have done historically and as we may decide to do in the future, presents additional risks and complexities and, if we decide to conduct a clinical trial outside of the U.S. in the future, we may not complete such trials successfully, in a timely manner, or at all, which could affect our ability to obtain regulatory approvals.
- Auryxia, 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.
- We may not be able to obtain marketing approval for any current or future product candidate, or we may experience significant delays in doing so, any of which would materially harm our business.
- Products approved for marketing are subject to extensive post-marketing regulatory requirements and could be subject to post-marketing restrictions or withdrawal from the 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 any of them is approved.
- We are subject to complex regulatory schemes that require significant resources to ensure compliance and our failure to comply with applicable laws could subject us to government scrutiny or enforcement, potentially resulting in costly investigations, fines, penalties or sanctions, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- Disruptions in the FDA, regulatory authorities outside the U.S. and other government agencies caused by global health concerns or funding shortages could prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
- Compliance with privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
- With the passage of the CREATES Act, we are exposed to possible litigation and damages by competitors who may claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-based terms
- for testing in support of their abbreviated new drug applications, or ANDAs, 505(b)(2) NDAs and biosimilar product applications.
- If 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.
- 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.
- 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.
- We rely upon third parties to conduct all aspects of our product manufacturing and commercial distribution, and in many instances only have a single supplier or distributor, and the loss of these manufacturers or distributors, their failure to
- 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 upon third parties to conduct our clinical trials and certain of our preclinical studies. If they do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain or maintain marketing approval for Auryxia, Vafseo or any of our product candidates, and our business could be substantially harmed.
- 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.
- 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.
- We may not be able to protect our intellectual property rights throughout the world.
- The 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.
- 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.
- Litigation 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.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- If we fail to attract, retain and motivate senior management and qualified personnel, we may be unable to successfully develop and commercialize Auryxia or Vafseo.
- We may encounter difficulties in managing our growth, including with respect to our employee base, and managing our partnerships and operations successfully.
- We have identified a material weakness in our internal control over financial reporting as of December 31, 2023 relating to our accounting for inventory and inventory related transactions. If we are not able to remediate this material weakness, or if we experience additional material weaknesses or other deficiencies in our internal control over financial reporting in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to
- accurately or timely report our financial results or prevent fraud, and we may conclude that our internal control over financial reporting is not effective, which may adversely affect our business.
- Security breaches and unauthorized use of our information technology systems and information, or the information technology systems or information in the possession of our collaborators and other third parties, could damage the integrity of our clinical trials, impact our regulatory filings, compromise our ability to protect our intellectual property, and subject us to regulatory actions that could result in significant fines or other penalties.
- Our financial statements include long-lived assets, including goodwill and an intangible asset as a result of the Merger. The intangible asset has become impaired and could become further impaired in the future under certain conditions. In addition, other long lived assets, including property and equipment, right-of-use assets or goodwill could become impaired in the future under certain conditions. Any potential future impairment of property and equipment, our right-of-use assets, goodwill or intangible asset may significantly impact our results of operations and financial condition.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of Auryxia or Vafseo.
- We 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.
- Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
- Our Charter designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We are currently subject to legal proceedings that could result in substantial costs and divert management's attention, and we could be subject to additional legal proceedings.
- 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.
- 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.
- Provisions 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.
- Because 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.
Management Discussion
- Product Revenue, Net—Net product revenue is derived only from sales of Auryxia in the U.S. until Vafseo's U.S. market entry, which is expected in January 2025. We distribute Auryxia principally through a limited number of wholesale distributors as well as certain specialty pharmacy providers.
- Net product revenue was $31.0 million for the three months ended March 31, 2024, compared to $34.7 million for the three months ended March 31, 2023. The decrease was primarily due to a reduction in volume partially offset by price increases and execution of our contracting strategy with third party payors.
- Auryxia will lose exclusivity in the U.S. in March 2025, which may have a negative impact on revenue. We believe CMS's decision to include phosphate binders in the dialysis bundle could potentially lead to higher sales of Auryxia after the LoE date than in other LoE scenarios, and plan to work with third-party payors and providers to continue the use of Auryxia beyond LoE.