Akebia Therapeutics Inc 2026年季度报告

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MarkOne) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March31, 2026 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) 02142(Zip Code) Registrant’s telephone number, including area code: (617)871-2098 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 Section13 or 15(d) of the Securities 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.YesNo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation 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).YesNo Indicate by check mark whether the registrant is a large acceleratedfiler, an acceleratedfiler, a non-acceleratedfiler, a smaller reporting company, or an emerginggrowth company. See the definitions of “large acceleratedfiler,” “acceleratedfiler,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of theExchange Act. Table of Contents 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 Securities Litigation Reform Act of 1995 with the intention of obtaining the benefits of the “safe harbor” provisions of that Act.All statements contained in this Quarterly Report on Form10-Q other than statements of historical fact are forward-looking statements.These forward-looking statements may be accompanied by words such as “anticipate,” “believe,” “build,” “can,” “contemplate,”“continue,” “could,” “should,” “designed,” “estimate,” “project,” “expect,” “forecast,” “future,” “goal,” “intend,” “likely,” “may,” “plan,”“possible,” “potential,” “predict,” “strategy,” “seek,” “target,” “will,” “would,” and other words and terms of similar meaning, but theabsence 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 any potential label expansion opportunities for Vafseo orany current or future product candidate;•our ability to maintain contracts with dialysis organizations for the sale of Auryxia® (ferric citrate) and Vafseo in the U.S.;•the potential therapeutic benefits, safety profile, and effectiveness of Vafseo and our product candidates;•our pipeline and portfolio, including its potential, and our related research and development activities, including with respect toAKB-097, praliciguat and AKB-9090;•the timing, investment and associated activities involved in continued commercialization of Auryxia, its growth opportunitiesand our ability to execute thereon;•the timing and number of additional generic versions of Auryxia that enter the market following the loss of exclusivity forAuryxia which occurred in March 2025, the amount of generic product available to supply the market, the pricing of genericversions of Auryxia, and the impact of the loss of exclusivity on the product revenue from Auryxia, including the impact on theprice of Auryxia;•the potential indications, demand and market opportunity, potential and acceptance of Auryxia, Vafseo and our productcandidates, including the size of eligible patient populations;•the potential therapeutic applications of the hypoxia inducible factor pathway;•the entry into therapeutic modalities, such as biologics, that differ significantly from our existing small-molecule expertise,potentially requiring the recruitment of personnel with new technical, regulatory, manufacturing, and commercializationcapabilities;•our competitive position, including estimates, developments and projections relating to our competitors and their products andproduct candidates, and our industry;•our expectations, projections and estimates regarding our capital requirements, need for additional capital,financing our futurecash needs, costs, expenses, revenues, capital resources, cashflows,financial performance, profitability, tax obligations,liquidity, growth, contractual obligations and the period of time our cash resources will fund our current operating plan,estimates with respect to our ability to operate as a going concern, our internal control overfinancial reporting and disclosurecontrols and procedures, and any future deficiencies or material