Akebia Therapeutics Inc 2025年季度报告

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM10-Q (MarkOne) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period endedMarch31, 2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 AKEBIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Not Applicable (Former name, former address and formerfiscal year, if changed since last report) Indicate by check mark whether the registrant: (1)hasfiled all reports required to befiled by Secon13 or 15(d) of the Securies Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required tofile such reports), and (2)has been subject to suchfiling requirements for the past90 days.YesýNo¨ Indicate by check mark whether the registrant has submied electronically every Interacve Data File required to be submied pursuant to Rule 405 of Regulaon S-T(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit suchfiles).YesýNo¨ Indicate by check mark whether the registrant is a large acceleratedfiler, an acceleratedfiler, a non-acceleratedfiler, a smaller reporng company, or an emerginggrowth company. See the definions of “large acceleratedfiler,” “acceleratedfiler,” “smaller reporng company,” and “emerging growth company” in Rule 12b-2 of theExchange Act. Table of Contents If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transion period for complying with any new or revisedfinancial accounng standards provided pursuant to Secon 13(a) of the Exchange Act.¨ CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements that are being made pursuant to the provisions of the U.S.Private Securies Ligaon Reform Act of 1995 with the intenon of obtaining the benefits of the “safe harbor” provisions of thatAct. All statements contained in this Quarterly Report on Form10-Q other than statements of historical fact are forward-lookingstatements. These forward-looking statements may be accompanied by words such as “ancipate,” “believe,” “build,” “can,”“contemplate,” “connue,” “could,” “should,” “designed,” “esmate,” “project,” “expect,” “forecast,” “future,” “goal,” “intend,”“likely,” “may,” “plan,” “possible,” “potenal,” “predict,” “strategy,” “seek,” “target,” “will,” “would,” and other words and terms ofsimilar meaning, but the absence of these words does not necessarily mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements about: •our plans with respect to commercializing Vafseo® (vadadustat) and label expansion opportunies currently underevaluaon for Vafseo;•our ability to maintain contracts with dialysis organizaons for the sale of Auryxia® (ferric citrate) and Vafseo in the U.S.;•the potenal therapeuc benefits, safety profile, and effecveness of Vafseo;•our pipeline and porolio, including its potenal, and our related research and development acvies;•theming, investment and associated acvies involved in connued commercializaon of Auryxia, its growth opportuniesand our ability to execute thereon;•the potenal indicaons, demand and market opportunity, potenal and acceptance of Auryxia and Vafseo, including thesize of eligible paent populaons;•the potenal therapeuc applicaons of the hypoxia inducible factor pathway;•our compeve posion, including esmates, developments and projecons relang to our competors and their productsand product candidates, and our industry;•our expectaons, projecons and esmates regarding our capital requirements, need for addional capital,financing ourfuture cash needs, costs, expenses, revenues, capital resources, cashflows,financial performance, profitability, taxobligaons, liquidity, growth, contractual obligaons and the period ofme our cash resources will fund our currentoperang plan, esmates with respect to our ability to operate as a going concern, our internal control overfinancialreporng and disclosure controls and procedures, and any future deficiencies or material weaknesses in our internalcontrols and procedures;•delivering value broadly to the kidney community, as well as others who may benefit from our medicines, will result indelivering value for stockholders;•the direct or indirect impacts of the COVID-19 pandemic on our business, operaons and the markets and communies inwhich we and our partners, collaborators, vendors, and customers operate;•our manufacturing, supply and quality maers and any recalls, write-downs, impairments or other related consequences orpotenal consequences;•esmates, beliefs and judgments related to the valuaon of goodwill, debt and other assets and liabilies, includingclassificaon of expenses, assets and