AKBA 10-K & 10-Q changes, risk factors and insider trading

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 profitableand orremain attain positive cash flows.profitable.

Investment in pharmaceutical product development and commercialization is highly speculative because it requires upfront capital expenditures and significant research and development, or R&D, expenses. Despite the investment in assets and R&D, there is significant risk that a product candidate will fail to gain marketing approval or that an approved product will not be commercially viable. Since our inception, we have devoted most of our resources to R&D, including our preclinical and clinical development activities, commercializing Auryxia and Vafseo and providing general and administrative support for these operations. We have funded our operations principally through product sales, payments received from our collaboration and licensing partners, borrowings under term loans, sales of our common stock, including through our employee stock purchase plan, a working capital payment from Vifor (International) Ltd. (now a part of CSL Limited), or CSL Vifor, and a royalty transaction. Prior to our 2018 merger, or the Merger, with Keryx Biopharmaceuticals, Inc., or Keryx, whereby Keryx became our wholly owned subsidiary, we had no products approved for commercial sale and had not generated any revenue from the sale of products. While weWe currently have two commercial products,products and believe that our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are notsufficient currentlyto profitablefund our current operating plan for at least two years, including to commercialize Vafseo and Auryxia and advance our existing programs. However, we have incurred net losses each year since our inception, including a net loss of $69.4$5.3 million for the year ended December 31, 2024.2025, As of December 31, 2024,and we had an accumulated deficit of $1.7 billion. We cannot guarantee when, if ever, we will become and remain profitable. As of December 31, 2025, we had an accumulated deficit of $1.7 billion.

InOn March 2022,27, we received a complete response letter, or CRL, from2024, the United States, or U.S., Food and Drug Administration, or FDA, regardingapproved our new drug application, or NDA, for vadadustat for the treatment of anemia associated with chronic kidney disease, or CKD. Following a Formal Dispute Resolution Request, or FDRR, to the FDA in 2022 for vadadustat, we filed a resubmission to our NDA in 2023. On March 27, 2024, the FDA approved our NDA for vadadustat under the trade name Vafseo for the treatment of anemia due to CKDchronic kidney disease, or CKD, in adults who have been receiving dialysis for at least three months. However, we expended significant additional resources to obtain the approval of Vafseo, and the commercialization of Vafseo was delayed due to the receipt of a complete response letter, or CRL, from the FDA in March 2022 regarding our NDA, and Vafseo was approved for a narrower indication than we initially pursued, which had and could continue to have an adverse effect on our business.

Our ability to generate product revenue and achieve and maintain profitability depends on our ability to manage expenses and the overall success of Auryxia, Vafseo and any current or future product candidates, including those that may be in-licensed or acquired, which depends on several factors, including:

•obtaining and maintaining adequate or favorable pricing and reimbursement from private and governmental payors for Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired;

•obtaining regulatory approval for any potential label expansion for Vafseo, including the timing and scope thereof;

•the potential impact of geopolitical pressurespressures, including tariffs and global trade policies, or the BIOSECURE Act on our ability to conduct our business as currently conducted;

•competing effectively with any products for the same or similar indications as our products (including generics); and

•maintaining, protecting and expanding our portfolio of intellectual property rights, including patents and trade secrets; andsecrets.

Our collaboration, license and other revenue also depends on our partners’ ability to successfully market and sell Vafseo and Auryxia in the territories in which they have licensed our products. For example, in May 2023, we entered into a license agreement with MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, pursuant to which we granted Medice an exclusive license to marketdevelop and sellcommercialize Vafseo for the treatment of anemia in patients with CKD in the European Economic Area, or the EEA, the United Kingdom, or UK, Switzerland and Australia, or collectively, the Medice Territory. Vafseo is currently marketed and sold by Medice in certain countries in the Medice Territory. If Medice’s launch of Vafseo in certain countries in the Medice Territory is delayed or their sales are lower than anticipated, we may not receive the revenue that we expect from Medice on the timing anticipated, or at all.

Pursuant to the Vifor License Agreement, CSL Vifor contributed $40.0 million to a working capital facility, or Working Capital Fund, established to partially fund our costs of purchasing Vafseo from our contract manufacturers. Pursuant to the terms of the Vifor Termination Agreement, we have agreed to repay the Working Capital Fund to CSL Vifor through quarterly tiered royalty payments ranging from 8% to 14% of our net sales of Vafseo in the U.S., or the WCF Royalty Payments. The WCF Royalty Payments will commencecommenced on July 1, 2025, and will continue until the earlier of (i) the cumulative total of the WCF Royalty Payments equals $40.0 million, or (ii) May 31, 2028. The WCF Royalty Payments are subject to minimum true-up milestones of $10.0 million, $20.0 million and $40.0 million, or the WCF Royalty True-Up Payments, on each of May 31, 2026, May 31, 2027 and May 31, 2028, respectively, or the WCF Royalty True-Up Dates. If the cumulative total of the WCF Royalty Payments paid to CSL Vifor on any given WCF Royalty True-Up Date is less than the respective WCF Royalty True-Up Payment, we will pay CSL Vifor a one-time payment equal to the difference between the WCF Royalty True-Up Payment and the cumulative total of the WCF Royalty Payments paid by us through such WCF Royalty True-Up Date. If we are not successful in commercializing Vafseo, including maintaining contracts with dialysis organizations on favorable terms, or at all, our expected revenue related to Vafseo would be adversely impactedimpacted, and we may be unable to repay all or part of the WCF Royalty Payments, which could have a material adverse impact on our consolidated financial statements.statements and our ability to achieve and maintain profitability.

Our ability to achieve and maintain profitability also depends on our ability to manage our expenses. We expect to continue to incur substantial additional operating expenses, including additional R&D expenses related to our pipeline, including AKB-097 and praliciguat, and additional R&D and selling, general and administrative expenses for ongoing developmentdevelopment, post-marketing requirements and commercialization of Auryxia and Vafseo, which could lead to operating losses for the foreseeable future. We will continue to incur substantial expenditures relating to continued commercialization and post-marketing requirements for Auryxia, Vafseo and any other products, including those that may be in-licensed or acquired, aswhich wellcould as costs relatinglead to operating losses for the R&Dforeseeable of Vafseo and any other product candidate, including those that may be in-licensed or acquired.future. Our prior losses have had, and expected future losses will continue to have, an adverse effect on our stockholders’ equity (deficit) equity and working capital.

In addition to any further costs not currently contemplated in our operating plan, our ability to achieve and maintain profitability and our financial position will depend, in part, on the rate of our future expenditures, the timing of our product, collaboration, license and other revenue, the timing and amount of any repayment of the WCF Royalty Payments, our continued compliance with the terms of the Agreement for the Provision of a Loan Facility, as amended, or the BlackRock Credit Agreement, with Kreos Capital VII (UK) Limited, which are funds and accounts managed by BlackRock Inc., collectively, BlackRock, and our ability to obtain additional funding, should it be needed. In addition, we expect to continue to incur significant expenses if and as we:

•seek regulatory approval for any potential label expansion for Vafseo;

•conduct discovery and development activities for additionalour products and product candidates or platforms that may lead to the discovery of additional product candidates;

•repay, and pay any associated pre-payment penalties, if applicable, the term loans in an aggregate principal amount of up to $55.0 million, or the Term Loans, that were made available to us pursuant to the BlackRock Credit Agreement;

•make royalty, milestone or other payments under our current and any future in-licensing agreementsagreements, the Q32 Purchase Agreement and the Vifor Termination Agreement;

Our expenses could increase beyond expectations if we are required by the FDA, the European Medicines Agency, or the EMA, or other regulatory authorities, or if we otherwise believe it is necessary, to change our manufacturing processes or assays, to bring on additional manufacturers, to amend or replace our study protocols, to perform studies different from or larger than those currently planned, to conduct any additional clinical trials, whether in order to obtain approval or as a post-approval study, including the post-approval studies required for Vafseo and any other additional clinical trial that we decide to conduct for Vafseo, or if there are any delays in completing any of these activities.

Because of the numerous risks and uncertainties associated with pharmaceutical product development and commercialization, we are unable to accurately predict the timing or amount of increased expenses or the associated revenue. TheAny net losses we may incur mayin the future could fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. In any particular quarter, our product revenue, the progress of our clinical development and our operating results could be below the expectations of securities analysts or investors, which could cause our stock price to decline.

In addition, our ability to generate revenue would be negatively affected if dialysis organizations are unwilling to include Auryxia or Vafseo in their formulary or the size of our addressable patient population is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we soughtsought, or the patient population for treatment is narrowed by competition, physician choice, coverage or reimbursement, or payor or treatment guidelines. Even though we generate product revenue from Auryxia and Vafseo in the U.S. and royalties from Riona (ferric citrate hydrate) and Vafseo in Japan, generate product revenue from Vafseo in the U.S., generate royalties fromand Vafseo in Europe and other territories where it is approved, and may generate revenue and royalties from the sale of any products that may be approved in the future, including those that may be in-licensed or acquired, we may never generate revenue and royalties that are significant enough for us to become and remain profitable, and we may need to obtain additional financing to continue to fund our operating plan.

As of December 31, 2024,2025, our cash and cash equivalents were $51.9$184.8 million. We expect to continue to expend substantial amounts of cash for the foreseeable future as we continue to commercialize Auryxia in the U.S.; develop and commercialize Vafseo in the U.S.; and develop and commercialize any other product or product candidate, including those that may be in-licensed or acquired. These expenditures will include costs associated with R&D, manufacturing, potentially obtaining marketing approvals and marketing products approved for sale. In addition, other unanticipated costs may arise. Because the outcomes of our current and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of funding necessary to successfully complete clinical development for any current or future product candidates or to complete post-marketing studies for Auryxia and Vafseo. Our future capital requirements depend on many factors, including:

•the scope, progress, results and costs of conducting clinical trials or any post-marketing requirements or any other clinical trials for Auryxia, VafseoVafseo, praliciguat, AKB-097, and any other product or product candidate, including those that may be in-licensed or acquired;

•the timing of, and the costs involved in obtaining, any potential label expansion for Vafseo or marketing approvals for any product candidate, including those that may be in-licensed or acquired, including to fund the preparation, filing and prosecution of regulatory submissions;

•the timing and number of additional generic versions of Auryxia that enter the market following loss of exclusivity, or LoE,LoE for Auryxia onwhich occurred in March 20, 2025, the pricing of generic versions of Auryxia and the timing of, and the magnitude of,Auryxia, the impact of LoE on the product revenue from Auryxia, including the impact on the price of Auryxia;

•the cost of securing and validating commercialmanufacturing manufacturingfacilities for any of our products and product candidates, including those that may be in-licensed or acquired, and maintaining our manufacturing arrangements for Auryxia and Vafseo or any other product,product or product candidate, including those that may be in-licensed or acquired, or securing and validating additional arrangements;

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 any future commercialization efforts.

We believe our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are sufficient to fund our current operating plan for at least twenty-fourtwo months.years, including to commercialize Vafseo and Auryxia and advance our existing programs. However, if our operating performance deteriorates significantly from the levels expected in our long-term operating plan, including if we do not achieve our future anticipated Vafseo revenue projections, it would have an adverse effect on our liquidity and capital resources and could affect our ability to achieve or maintain profitability or continue as a going concern in the future. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves numerous risks and uncertainties, and actual results could vary as a result of a number of factors, many of which are outside our control. We have based this estimate on assumptions that may be substantially different than actual results, and we could utilize our available capital resources sooner than we currently expect. In addition, if we fail to satisfy any of the covenants under the BlackRock Credit Agreement, and the loan is accelerated, or if certain pre-specified events occur and we are required to make principal payments to BlackRock sooner than we currently anticipate, such event could have a material adverse effect on our business. There can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, or that our cash resources and cash we expect to generate will fund our operating plan for the period anticipated by us, or that additional funding will be available on terms acceptable to us, or at all.

Any additional fundraising efforts may divert our management’s attention away from their day-to-day activities, which may adversely affect our ability to develop and commercialize Auryxia, Vafseo and any other products or product candidates, including those that may be in-licensed or acquired. Also, additional funds may not be available to us in sufficient amounts or on acceptable terms or at all. In addition, raising funds in the current economic environment may present additional challenges. For example, any sustained disruption in the capital markets from adverse macroeconomic conditions and an uncertain geopolitical environment, such as tariffs, rising inflation, increasing interest rates, slower economic growth or recession, global trade policies, global supply chain disruptions, ongoing conflicts including the Russia-Ukraine war, thehostilities Israel-Hamasbetween warIsrael and theHamas, warinstability in the Middle East andEast, tensions between China and Taiwan,Taiwan and other emerging geopolitical crises, could negatively impact our ability to raise capital, and we cannot predict the extent or duration of such macroeconomic disruptions. If we are unable to raise additional capital in sufficient amounts when needed or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development and/or commercialization of Auryxia, Vafseo and any other products or product candidates, including those that may be in-licensed or acquired. Any of these events could significantly harm our business, financial condition and prospects.

We expect to finance future cash needs through product revenue and royalty and license revenue, and we may seek to sell public or private equity, enter into new debt transactions, explore potential strategic transactions or a combination of these approaches or other strategic alternatives. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, our fixed payment obligations may increase, any such securities may have rights senior to those of our common stock, and the terms may include liquidation or other preferences and anti-dilution protections that adversely affect the rights of our common stockholders. For example, sincefrom September 12, 2024 (the date our shelf registration statement on Form S-3 went effective) through December 31, 2024, we sold 14,271,631 shares of our common stock in an at-the-market offering with gross proceeds of $24.3 million, and during the year ended December 31, 2025, we sold 9,437,364 shares of our common stock under this program with gross proceeds of $18.7 million. In addition, on March 21, 2025, we sold 25,000,000 shares of our common stock in an underwritten public offering with net proceeds of $46.5 million, and on April 22, 2025, we sold an additional 850,000 shares of our common stock in connection with the partial exercise of the underwriters' 30-day option to purchase additional shares in such underwritten public offering with net proceeds of $1.6 million. Additional debt financing, if available, may involve agreements that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, make capital expenditures, declare dividends, acquire, sell or license intellectual property rights, and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic transactions, we may have to relinquish valuable rights to our portfolio and future revenue streams, and enter into agreements that would restrict our operations and strategic flexibility. If we raise additional funds through strategic transactions with third parties, we may have to do so at an earlier stage than otherwise would be desirable. In connection with any such strategic transactions, we may be required to relinquish valuable rights to our product and product candidates, future revenue streams or research programs or grant licenses on terms that are not favorable to us. If we are unable to raise additional funds when needed, we may not be able to pursue planned development and commercialization activities and we may need to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

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. For example, on November 28, 2025, we acquired AKB-097, a clinical-stage development candidate with the potential to treat rare kidney diseases.

Research programs to identify product candidates require substantial technical, financial and human resources, regardless of whether product candidates are ultimately identified. Our R&D programsprograms, including our rare kidney disease pipeline, may initially show promise, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following:

Because we have limited financial and managerial resources, we have focused on products, research programs and product candidates for specific indications. As a result, we have had to, and in the future may need to, forgo or delay pursuit of opportunities with other product candidates or for other indications, or may out license rights to product candidates, that later prove to have greater commercial potential. For example, as a result of receipt of the CRL and implementation of the reductions in workforce, we delayed certain research activities. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities on a timely basis, or at all. Our spending on current and future R&D programs and product candidates for specific indications may not yield any commercially viable products.

Because our internal research capabilities are limited, we may be dependent upon other pharmaceutical and biotechnology companies, academic scientists and institutions, and other researchers to sell or license product candidates, products or technology to us. As a result, our rights to these product candidates may be limited or we may be required to make future payments to such third parties if we are successful in developing such product candidates. For example, under the terms of the Q32 Purchase Agreement, we (i) will make an additional upfront payment to Q32 in an amount equal to $3.0 million on the sixth-month anniversary of the APA Closing Date, (ii) will make certain milestone payments upon the achievement of specified development and regulatory milestone events related to AKB-097 up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the earlier of initiation of a Phase 2 clinical trial and December 31, 2026, (iii) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the net sales of AKB-097 up to an aggregate amount equal to $487.5 million, and (iv) will make certain royalty payments based on the net sales of AKB-097 with royalty percentage tiers ranging from the low single digits to mid-teen percentages. The success of this strategy depends partly upon our ability to identify, select, and acquire promising product candidates and products. The process of identifying, selecting, negotiating and implementing a license or acquisition of a product candidate or an approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of a product candidate or an approved product. We have limited resources to identify and execute the acquisition or in-licensing of third party products, businesses, and technologies and integrate them into our current infrastructure.

Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.efforts, such as with respect to the acquisition of our clinical-stage development candidate AKB-097 and the in-license of our clinical-stage development candidate praliciguat. Any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA, the EMA, the Japanese Pharmaceuticals and Medical Devices Agency, or PMDA, or other regulatory authorities, or post-approval testing or other requirements if approved. All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot provide assurance that any of our products will be manufactured in a cost effective manner, achieve market acceptance or not require substantial post-marketing clinical trials.

As part of our business strategy, we may engage in additional strategic transactions to expand and diversify our portfolio, including through the merger, acquisition or in-license of assets, businesses, or rights to products, product candidates or technologies or through strategic alliances or collaborations, similar to the Merger and our existing and prior collaboration and license arrangements. We may not identify suitable strategic transactions, or complete such transactions in a timely manner, on favorable terms, on a cost-effective basis, or at all. Moreover, we may devote resources to potential opportunities that are never completed or we may incorrectly judge the value or worth of such opportunities. Even if we successfully execute a strategic transaction, we may not be able to realize the anticipated benefits of such transaction and may experience losses related to our investments in such transactions. Integration of an acquired company or assets into our existing business may not be successful and may disrupt ongoing operations, require the hiring of additional personnel and the implementation and integration of additional internal systems and infrastructure, and require management resources that would otherwise focus on developing our existing business. Even if we are able to achieve the long-term benefits of a strategic transaction, our expenses and short-term costs may increase materially and adversely affect our liquidity. Any of the foregoing could have a detrimental effect on our business, results of operations and financial condition. For example, the acquisition of AKB-097 on November 28, 2025 is expected to increase research and development expenses and require significant management attention for integration, which could divert resources from other priorities, raise short‑term costs, and adversely affect our liquidity. In addition, on June 4, 2021, we entered into a license agreement, or the Cyclerion Agreement, with Cyclerion Therapeutics Inc., or Cyclerion, pursuant to which Cyclerion granted us an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oraloral, once-daily soluble guanylate cyclase stimulator.stimulator being evaluated for the treatment of biopsy-confirmed focal segmental glomerulosclerosis, a rare kidney disease, with plans to assess its use in other rare podocytopathies in the future. In December 2024, we entered into an amendment to the Cyclerion Agreement, pursuant to which we amended the terms of the Cyclerion Agreement,Agreement and we now control all clinical and commercial manufacturing of praliciguat, which will be conducted by a third partythird-party manufacturer. Although we have progressed preclinical studies for praliciguat, we needneeded to do additional work to manufacture product for clinical trials than originally anticipated before we cancould initiate the trials,trial andfor whenpraliciguat, on January 6, 2026, we announced that the first patient was dosed in a Phase 2 clinical trial in the U.S. However, even though the clinical trialstrial arehas started, we may be unsuccessful in developing praliciguat. If any of the assumptions that we made in valuing the transaction,transactions, including the costs or timing of development of praliciguat as a result of the additional manufacturing workAKB-097 or otherwise,praliciguat, or the potential benefits of AKB-097 or praliciguat, were incorrect, we may not recognize the anticipated benefits of the transactiontransactions and our business could be harmed.

•entry into indications or markets in which we have no or limited development or commercial experience and where competitors in such markets have stronger market positions; and

We entered into the BlackRock Credit Agreement, which provides for a senior secured term loan facility, in the aggregate principal amount of up to $55.0 million, or the Term Loan Facility. The initial tranche of $37.0 million, or the Tranche A Loan, closed on January 29, 2024, or the Closing Date, an additional amount of $8.0 million, or the Tranche B Loan, was drawn on April 19, 2024, and an additional $10.0 million was drawn on February 3, 2025, or the Tranche C Loan and, together with the Tranche A Loan and the Tranche B Loan, the Term Loans. See Note 7, Indebtedness, to our audited consolidated financial statements in Part II, Item 8. Financial Statements and Supplementary Data of this Form 10-K for additional information regarding our obligations under the BlackRock Credit Agreement. The Term Loan Facility hadhas an initiala maturity date of March 31, 2025, which was automatically extended to January 29, 2028, or the Maturity Date, since we received FDA approval for Vafseo prior to June 30, 2024.Date.

The Term Loan Facility will accrue interest at a floating annual rate equal to the sum of (x) term Secured Overnight Financing Rate for a tenor of one month (subject to a floor of 4.25% per annum) plus (y) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate). During the continuance of any payment event of default under the BlackRock Credit Agreement, the interest rate on such overdue sum will automatically increase by an additional 3.0% per annum, and may be subject to an additional late fee of 2.0% of such overdue sum. The Term Loan Facility does not amortize during the period commencing on the Closing Date and ending on December 31, 20252026 (which wasas extended to December 31, 2026 at our option), or the Interest Only Period. We are required to pay interest and, after the Interest Only Period, principal on the first calendar day of each month. In the event of certain prespecified events, the repayment schedule will be accelerated. If any of these events occur, and we are required to repay principal sooner than we anticipate, it would have an adverse effect on our business.

In February 2021, we entered into a royalty interest acquisition agreement, or the Royalty Agreement, with HealthCare Royalty Partners IV, L.P., or HCR, pursuant to which we sold to HCR our right to receive royalties and sales milestones for Vafseo, collectively the Royalty Interest Payments, in each case, payable to us under our Collaboration Agreement dated December 11, 2015, or the MTPCTPC Agreement, with Tanabe Pharma Corporation, formerly Mitsubishi Tanabe Pharma Corporation, or MTPC,TPC, subject to an annual maximum “cap” of $13.0 million, or the Annual Cap, and an aggregate maximum “cap” of $150.0 million, or the Aggregate Cap. Under the Royalty Agreement, we are required to comply with various covenants, including obligations to take certain actions, such as actions with respect to the Royalty Interest Payments, the MTPCTPC Agreement, our agreement with MTPCTPC for the commercial supply of Vafseo drug product, and our intellectual property. In addition, the Royalty Agreement includes customary events of default upon the occurrence of enumerated events, including failure to perform certain covenants and the occurrence of insolvency events. Upon the occurrence of an event of default, HCR would have the ability to exercise all available remedies in law and equity, which could have a material adverse effect on our financial condition.

We currently havehad exclusive rights under a series of patents and patent applications to commercialize Auryxia in the U.S. that protectprotected us from generic drug competition until March 20, 2025. Following LoE, on March 20, 2025, the number of generic versions of Auryxia that enter the market, and the timing thereof, will adversely affect our revenue from Auryxia. TheOn February 5, 2025, we entered into an Authorized Generic Distribution and Supply Agreement with Mylan Pharmaceuticals, Inc., or AG Distributor, as amended in September 2025, pursuant to which, since March 20, 2025, they have been selling an authorized generic version of Auryxia. On January 22, 2026, Pharmaceuticals Ltd., or Teva, received tentative approval for its Abbreviated New Drug Application for Auryxia. Currently, there is only one authorized generic for Auryxia sold by our distributor, but we expect additional generic competition in 2026. If additional generic versions of Auryxia are approved and enter the market, we expect it will adversely impact ofour LoErevenue. However, the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics and the pricing of generics and other products on the market that compete with Auryxia. In addition, we believe the dynamics of Auryxia reimbursement being included in the ESRD bundle under Medicare Part B and Auryxia LoE could result in the buying pattern of certain customers in 2025 and future years being different than their historical practices. If Auryxia sales decline faster than we anticipate following LoE, our results of operations and financial condition will be materially harmed.

Given the concentration of dialysis clinics in large networks, with DaVita, Inc., or DaVita, Fresenius Kidney Care Group LLC, or Fresenius, and U.S. Renal Care, or USRC, accounting for a vast majority of the dialysis population in the U.S., treatment is usually driven by medical protocols that are implemented across the entire network of clinics. Dialysis organizations require large data sets to adopt medical protocols.protocols Ifand often have lengthy processes to implement and operationalize the protocol and make the new therapy available for patients. In addition, some dialysis organizations do not add Vafseo to theirhave medical protocols inthat arequire timelyspecific manner,steps oronce atVafseo all,is orprescribed ifthat lengthens the protocolstime service smaller populations thanbefore the currentpatient label,starts ourtreatment, resultsdelaying ofinitial operations could be materially adversely affected.adoption.

Oral-only phosphate binders, including Auryxia, are included in the end-stage renal disease, or ESRD, Prospective Payment System, or PPS, bundle payment, as of January 2025. In addition, dialysis organizations may choose lower cost binders over Auryxia, or binders that may have features or benefits more aligned with the dialysis organization's operational activities, which could negatively impact Auryxia revenue. We believe our revenue growth for Auryxia has been negatively impacted by the COVID-19 pandemic since 2021 primarily as the CKD patient populations that we serve experienced both high hospitalization and mortality rates due to COVID-19,COVID-19 and other infectious diseases, and the pandemicavailability hadand anuses adverseof impactvaccines, ontreatments theand phosphatetherapies binderhas market in which Auryxia competes.increased. Labor shortages and increased costs have also adversely impacted dialysis providers. These impacts have refocused clinical efforts in addressing bone and mineral disorders likesuch as hyperphosphatemia to more acute operational issues to ensure patients receive dialysis treatmentstreatments. and stillStill some patients have been rescheduled or missed treatments due to labor shortages. In addition, new CKD non-dialysis treatments could slow the progression of CKD non-dialysis patients to dialysis. We believe,believe this and potentially otherthese factors, ledamong others, have contributed to the continued reduction in the phosphate binder market, which has not experienced growth since early 2020. While we are unable to quantify the impact of thethese COVID-19 pandemiceffects on future revenuesAuryxia and revenue growth, the COVID-19 pandemic and therevenues, ongoing impacts from themarket COVID-19and pandemicpatient population challenges could continue to adversely and disproportionately impact CKD patients and the phosphate binder market. Therefore, we expect the impacts from thethese pandemicfactors to continue tocould have a negative impact on our Auryxia revenue growth for the foreseeable future.

Market acceptance is also critical to our ability to generate significant product revenue. Any product may achieve only limited market acceptance or none at all. If Auryxia, Vafseo or any of our future products is not accepted by the market to the extent that we expect or market acceptance decreases, we may not be able to generate significant product revenue and our business would be materially harmed. For example, an unexpected number of patients initially prescribed Vafseo have discontinued treatment. While we continue to work with dialysis organizations to improve adherence, if a higher than expected number of patient discontinuations persists, or increases, this could negatively impact the market acceptance of Vafseo, and could adversely affect our financial results. Market acceptance of Auryxia, Vafseo or any other approved product depends on a number of factors, including:

In addition, our ability to generate net product revenue depends on our ability to control the expenses associated with commercializing a product, including internal expenses, manufacturing costs, rebates, product returns and other adjustments. We do not have control over many of the expenses required to commercialize our products, and if we experience increased costs or expenses, we may not be able to afford the commercial activities required to successfully commercialize our products, which could have an adverse effect on our business. In addition, our net product revenue requires judgementjudgment and includes estimates for rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year. If our net product revenue is lower than anticipated, including as a result of higher expenses or product returns, our business could be harmed.

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

In order to market Auryxia, Vafseo and any other approved product, we intend to continue to invest in sales and marketing, which will require substantial effort and significant management and financial resources. We have built a commercial infrastructure and sales force in the U.S. for Auryxia and Vafseo. If the sales and marketing team cannot successfully commercialize Auryxia or Vafseo, it could have a material adverse effect on our product revenue and our financial condition. Additionally, training a sales force to successfully sell and market a new commercial product is expensive and time-consuming and could delay any commercial launch or market acceptance of such product. We may underestimate the size of the sales force required for a successful product launch, and we may need to expand our sales and marketing team to a greater extent than we already have, which would increase our costs more than we anticipated.

We are a fully integrated,integrated biopharmaceutical company with two commercial products for patients impacted by kidney disease. We have built a business focused on developing and commercializing innovative therapeutics that we believe serve as a foundation for future growth.growth, Ourincluding teamby hascontributing significantnet expertiseproduct inrevenue hypoxia-inducibleto factor,support orthe HIF, science having developeddevelopment and commercializedadvancement Vafseo®of (vadadustat),our anrobust oralpipeline HIFof factormid-stage prolylprograms hydroxylase,targeting orrare HIF-PH,kidney inhibitordiseases and haveearly-stage selectedprograms twotargeting additionalkidney HIF-baseddisease moleculesand fornon-kidney preclinicalfocused development.indications.

We have established the companyCompany as a leader in the kidney community,community and we believe our cross-organizational expertise in renalkidney disease positions the companyus for success. Chronic kidney disease, or CKD, is a condition in which the kidneys are progressively damaged to the point that they cannot properly filter the blood circulating in the body. This damage causes waste products to build up in the patient’s blood, leading to other health problems, including anemia, cardiovascular disease and bone disease. CKD significantly impacts the U.S.United States, or U.S., healthcare system, potentially affecting approximately 3735.5 million patientspatients. andIn costing2022, Medicarein nearlythe $125 billion annually forU.S. treating Medicare beneficiaries with CKD orcost end-stagean renalestimated disease,$95.7 or ESRD, according to the Centers for Disease Controlbillion, and Prevention.treating people on dialysis cost an estimated $45.3 billion. Our two commercial products address certain complications of kidney disease.

Our current product portfolio includes:

Vafseo® (vadadustat) is an orally administered medicine that was approved by the U.S. Food and Drug Administration, or the FDA, in March 2024 for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Shipment of Vafseo commenced in January 2025. We have commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. The current U.S. market opportunity for the treatment of anemia due to CKD in patients with dialysis is approximately $1 billion based on current ESAerythropoiesis pricingstimulating andagent, or ESA, pricing. Vafseo is the only oral HIF-basedhypoxia inducible factor, or HIF, based treatment available in the U.S. Vafseo entered the market in January 2025, at which time we had commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. Throughout 2025, we worked closely with dialysis organizations as their medical teams developed, implemented and operationalized protocols to enable prescribers to write Vafseo prescriptions for clinically appropriate patients. Currently, approximately 290,000 dialysis patients in the U.S. have prescribing access to Vafseo.

Today, we market Auryxia in the U.S. Auryxia became part of our portfolio in 2018 and has historically contributed meaningful revenue to the business. In March 2025, Auryxia willreached loseloss of exclusivity, or LoE. WeOn believeJanuary 22, 2026, Teva Pharmaceuticals Ltd., or Teva, received tentative approval for its Abbreviated New Drug Application for Auryxia. Currently, there is only one authorized generic for Auryxia sold by our distributor, but we expect additional generic competition in 2026. If additional generics are approved and enter the dynamicsmarket, ofwe Auryxiaexpect reimbursementit beingwill included in the ESRD bundle under Medicare Part B could result in slower revenue decline after the LoE date than in other LoE situations, but theadversely impact of LoE on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of generics and the pricing of generics and other products on the market that compete with Auryxia.revenue.

Our mid-stage rare kidney disease pipeline assets, praliciguat and AKB-097, are being evaluated to target areas of unmet need. In June 2021, we acquiredlicensed praliciguat from Cyclerion Therapeutics, Inc., or Cyclerion, via an exclusive global licenselicense, underwhich includes certain intellectual property rights to research, develop and commercialize praliciguat,the asset. Praliciguat is an investigationaloral, oralonce-daily soluble guanylate cyclase, or sGC, stimulator. We believeare thereevaluating ispraliciguat potentialfor the treatment of biopsy-confirmed focal segmental glomerulosclerosis, or FSGS, a rare kidney disease, in a Phase 2 clinical trial. The first patient was dosed in this trial in December 2025. We also plan to exploreassess the use of praliciguat forin indicationsother withinrare kidneypodocytopathies disease.in the future.

We generate product revenue from commercial sales of Auryxia inand the U.S.Vafseo to a limited number of customers, including dialysis organizations, wholesale distributors anddistributors, certain specialty pharmacy providers.providers and our authorized generic distribution partner, Mylan Therapeutics, Inc., or AG Distributor. Our net product revenue includes many variables, including judgments and estimates of discounts, rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year. We evaluate, at least annually and more frequently, if needed, the price of Auryxia, which will lose exclusivity in March 2025. We expect our product revenue to continue to be generated from our commercial sales of Auryxia as well as to be generated from our commercial sales of Vafseo following its U.S. market entry in January 2025.

We believehad exclusive rights under a series of patents and patent applications to commercialize Auryxia in the dynamicsU.S. that protected us from generic drug competition until March 20, 2025. Following LoE, since March 2025, our AG Distributor has been selling an authorized generic version of Auryxia reimbursement being included in the end-stageU.S. renal disease, or ESRD, bundle under Medicare Part B and Auryxia LoE on March 20, 2025, could result in the buying pattern of certain customers in future years being different than their historical practices. In addition, we believe the dynamics of Auryxia reimbursement moving to Medicare Part B could result in slower revenue decline after the LoE date than in other LoE scenarios, but theThe impact of LoE on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics and the pricing of generics and other products on the market that compete with Auryxia.

We expect to continue to generate revenue from our collaboration, license, and supply agreements with Medice, MTPC,TPC, JT and Torii and any other collaborations into which we have entered or may enter.

Cost of goods sold, or COGS, - Cost of product and other revenue includes costs closely correlated or directly related to the costs to manufacture commercial drug substance and drug product, including at our contract manufacturing organizations, or CMOs, as well as indirect costs. Direct and indirect costs include fees for packaging, shipping, insurance and quality assurance, idle capacity charges, changes in reserves for excess inventory, write-offs for inventory that fails to meet specifications or is otherwise no longer suitable for commercial sale, including scrap, changes in our firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S. and Japan product sales recognized during the period.

COGSCost of product and other revenue also includes costs to manufacture drug product provided to MTPCTPC and Medice for commercial sale of Vafseo in Japan and in the European Economic Area, or EEA, the United Kingdom, or UK, Switzerland and Australia, or collectively the Medice Territory, respectively, as well as to our AG Distributor. In addition, cost of product and other revenue includes personnel-related costs, including salaries and bonuses, employee benefits and stock-based compensation attributable to employees in particular functions and associated directly with the manufacturing of our commercial products.

Cost of goods sold -: Amortization of intangible asset - In addition, COGScost of product and other revenue included the amortization of development product rights for Auryxia through the end of 2024.

R&D expenses consist primarily of costs incurred for the development of Vafseo prior to regulatory approval and costs associated with our pipeline which includes:

•costs associated with the pre-launch inventory build for Vafseo in the U.S. prior to FDA approval in March 2024 and in Europe prior to the European Commission, or EC,Commission approval in April 2023.

From inception through December 31, 2024,2025, we have incurred $1.7 billion in R&D expenses. We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Auryxia, VafseoVafseo, praliciguat, AKB-097 and any other product or product candidate, including those that may be in-licensed or acquired.

Each of our products and product candidates has technical, clinical, regulatory,regulatory and commercial risk, including those discussed more fully under the heading “Risk Factors” in Part I, Item 1A of this Form 10-K. A change in the outcome of any of the variables with respect to the development of Auryxia, Vafseo or any other product or product candidate could result in a significant change in the costs and timing associated with that development.

See Note 7,10, Indebtedness,Commitments and Note 18, Subsequent Events,Contingencies, in the accompanying notes to the consolidated financial statements included in Part II, Item 8 of this Form 10-K for further information.information on the Cyclerion Agreement.

See Note 8,10, Liability Related to Settlement Royalties, Working Capital Fund LiabilityCommitments and Liability Related to Sale of Future Royalties,Contingencies, in the accompanying notes to the audited consolidated financial statements included in Part II, Item 8 of this Form 10-K for further information on the ViforQ32 TerminationPurchase Agreement.

Product Revenue, Net—Net product revenue wasis derived solely from sales of Auryxia and Vafseo in the U.S. until Vafseo's U.S. market entry in January 2025. We distribute Auryxia and Vafseo principally through a limited number of dialysis organizations, wholesale distributors anddistributors, certain specialty pharmacy providers.providers and our AG Distributor for Auryxia.

Auryxia will loselost exclusivity in the U.S. in March 2025, which may have a negative impact on future Auryxia revenue. WeFollowing believeLoE, theour dynamicsAG Distributor has been selling an authorized generic version of Auryxia reimbursement being included in the ESRDU.S., bundlewhich undermay Medicareslightly Partoffset B could result in slowera revenue decline after theentry LoE date than inof other LoE scenarios.generics. However, our ability to continue to generate revenue from sales of Auryxia following LoEentry of other generics will depend on many factors, including our ability to maintain contracts with dialysis organizations, the timing and number of additional generics that enter the market and the pricing of generics and other products on the market that compete with Auryxia.

Investment in pharmaceutical product development and commercialization is highly speculative because it requires upfront capital expenditures and significant research and development, or R&D, expenses. Despite the investment in assets and R&D, there is significant risk that a product candidate will fail to gain marketing approval or that an approved product will not be commercially viable. Since our inception, we have devoted most of our resources to R&D, including our preclinical and clinical development activities, commercializing our two approved products, Auryxia and VafseoVafseo, and providing general and administrative support for these operations. We have funded our operations principally through product sales, payments received from our collaboration and licensing partners, borrowings under term loans, sales of our common stock, including through our employee stock purchase plan, a working capital payment from Vifor (International) Ltd. (now a part of CSL Limited), or CSL Vifor, and a royalty transaction. Prior to our 2018 merger, or the Keryx Merger, with Keryx Biopharmaceuticals, Inc., or Keryx, whereby Keryx became our wholly owned subsidiary, we had no products approved for commercial sale and had not generated any revenue from the sale of products. We currently have two commercial products and believe that our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are sufficient to fund our current operating plan for at least two years,years. includingThis estimate is contingent upon us refinancing the outstanding debt under our senior secured term loan facility to commercializedefer Vafseothe andpayment Auryxiaof andprincipal, advancewhich would otherwise commence on January 1, 2027. See Note 7, Indebtedness, to our unaudited condensed consolidated financial statements in Part I, Item 1. Financial Statements of this Quarterly Report on Form 10-Q, or Form 10-Q, for additional information regarding our obligations under our senior secured term loan facility. However, there can be no assurance that we will be able to refinance our senior secured term loan facility on favorable terms or at all. If we are unable to execute such refinancing on favorable terms or at all, we believe that our existing programs.cash However,resources and the cash we expect to generate from product, royalty, supply and license revenues will be sufficient to enable us to fund our current operating plan for at least 12 months from the filing of this Form 10-Q. Since inception, we have incurred net losses each year since our inception,year, including a net loss of $9.1$8.9 million and $18.0 million for the three and six months ended MarchJune 31,30, 2026, respectively, and we cannot guarantee when, if ever, we will become and remain profitable. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.7 billion.

On March 27, 2024, the United States, or U.S.,U.S. Food and Drug Administration, or FDA, approved our new drug application, or NDA, for vadadustat under the trade name Vafseo for the treatment of anemia due to chronic kidney disease, or CKD, in adults who have been receiving dialysis for at least three months. However, we expended significant additional resources to Akebia Therapeutics, Inc. | Form 10-Q | Page 42 obtain the approval of Vafseo, and the commercialization of Vafseo was delayed due to the receipt of a complete response letter, or CRL, from the FDA in March 2022 regarding our NDA, and Vafseo was approved for a narrower indication than we initially pursued, which had and could continue to have an adverse effect on our business.

Our ability to generate product revenue and achieve and maintain profitability depends on our ability to manage expenses and the overall success of Auryxia, including our authorized generic version of Auryxia, Vafseo and any current or future product candidates, including those that may be in-licensed or acquired,acquired. whichOur ability to generate product revenue depends on several factors, including:

•obtaining and maintaining adequate or favorable pricing and reimbursement from private and governmental payors for Auryxia, Vafseo and any other product or product candidate,candidate that may be approved, including those that may be in-licensed or acquired;

•obtainingthe extent that we, or our collaboration partners, are able to obtain and maintainingmaintain market acceptance of Auryxia, the authorized generic version of Auryxia, Vafseo and any of our other product candidate,candidate that may be approved, including those that may be in-licensed or acquired;

•the size of any market infor whichour Auryxia,approved Vafseoproducts andor any other product or product candidate, including thosecandidates that may be in-licensedapproved, and the extent to which we or acquired,our receivescollaboration approvalpartners are able to obtain and obtainingmaintain adequate market share in those markets;

•maintaining marketing approvals for Auryxia, Vafseo and any other product,product candidate that may be approved, including those that may be in-licensed or acquired;

•our ability to maintain contracts with dialysis organizations for the sale of Auryxia and Vafseo in the U.S. on favorable terms, or at all;

•the timing and number of additional generic versions of Auryxia that enter the market following loss of exclusivity, or LoE, for Auryxia whichthat occurred in March 2025, the availability and pricing of generic versions of Auryxia, the impact of LoE on the product revenue from Auryxia, including the impact on the price of Auryxia;

•establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate supplies of products that are compliant with good manufacturing practices, or GMPs,practices to support the clinical development and the market demand for Auryxia, Vafseo and any other product and product candidate, including those that may be in-licensed or acquired;

•the potentialextent of the impact of geopolitical pressures, including tariffs and global trade policies, or the BIOSECURE Act on our ability to conduct our business as currently conducted;

•the effectiveness of our collaborators' and our sales,marketing, marketing,promotion, manufacturing and distribution strategies and operations;

Our collaboration,license, licensecollaboration and other revenue also depends on our partners’ ability to successfully market and sell Vafseo and Auryxia in the territories in which they have licensed our products. For example, in May 2023, we entered into a license agreement with MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, pursuant to which we granted Medice an exclusive license to develop and commercialize Vafseo for the treatment of anemia in patients with CKD in the European Economic Area, or the EEA, the United Kingdom, or the UK, Switzerland and Australia, or collectively, the Medice Territory. Vafseo is currently marketed and sold by Medice in certain countries in the Medice Territory. Previously, Medice's launch of Vafseo in certain countries in the Medice Territory was later than anticipated due to required prerequisite activities. If Medice’s launch of Vafseo in certain Akebia Therapeutics, Inc. | Form 10-Q | Page 43 countries in the Medice Territory is further delayed or their sales are lower than anticipated, we may not receive the revenue that we expect from Medice on the timing anticipated, or at all.

In July 2024, we entered into a Termination and Settlement Agreement with CSL Vifor, or the Vifor Termination Agreement. Pursuant to the Vifor Termination Agreement, we agreed, among other things, to terminate, effective immediately, the Second Amended and Restated License Agreement that we entered into with CSL Vifor in February 2022, as amended in May 2024, or the Vifor License Agreement, pursuant to which we granted CSL Vifor an exclusive license to sell Vafseo to Fresenius Medical Care North America and its affiliates, including Fresenius Kidney Care Group LLC, to certain third-party dialysis organizations approved by us, to independent dialysis organizations that are members of certain group purchasing organizations, or GPOs, and to certain non-retail specialty pharmacies in the U.S., which represents a significant portion of the potential market for Vafseo. Asas a result, we have regained our rights to sell Vafseo to Fresenius Kidney Care North America and its affiliates and certain other third-party dialysis organizations in the U.S.

Pursuant to the Vifor License Agreement, CSL Vifor contributed $40.0 million to a working capital facility, or Working Capital Fund, established to partially fund our costs of purchasing Vafseo from our contract manufacturers. Pursuant to the terms of the Vifor Termination Agreement, we have agreed to repay the Working Capital Fund to CSL Vifor through quarterly tiered royalty payments ranging from 8% to 14% of our net sales of Vafseo in the U.S., or the WCF Royalty Payments. The WCF Royalty Payments commenced on July 1, 2025, and will continue until the earlier of (i) the cumulative total of the WCF Royalty Payments equals $40.0 million, or (ii) May 31, 2028. The WCF Royalty Payments are subject to minimum true-up milestones of $10.0 million, $20.0 million and $40.0 million, or the WCF Royalty True-Up Payments, on each of May 31, 2026, May 31, 2027 and May 31, 2028, respectively, or the WCF Royalty True-Up Dates. If the cumulative total of the WCF Royalty Payments paid to CSL Vifor on any given WCF Royalty True-Up Date is less than the respective WCF Royalty True-Up Payment, we will pay CSL Vifor a one-time payment equal to the difference between the WCF Royalty True-Up Payment and the cumulative total of the WCF Royalty Payments paid by us through such WCF Royalty True-Up Date. If we are not successful in commercializing Vafseo, including maintaining contracts with dialysis organizations on favorable terms, or at all, our expected revenue related to Akebia Therapeutics, Inc. | Form 10-Q | Page 49 Vafseo would be adversely impacted, and we may be unable to repay all or part of the WCF Royalty Payments, which could have a material adverse impact on our consolidated financial statements and our ability to achieve and maintain profitability.

In addition, on November 28, 2025, or the APA Closing Date, we entered into an Asset Purchase Agreement, or the Q32 Purchase Agreement, with Q32 Bio Inc. and Q32 Bio Operations Inc., together, Q32, pursuant to which we purchased and assumed from Q32 substantially all assets and liabilities of Q32 and its affiliates related to the research, development, manufacture, and commercialization of Q32’s clinical-stage development candidate ADX-097, known as ADX-097ebribafusp (now referred to as AKB-097, generic name ebribafuspAKB-097) worldwide for the treatment, prevention or diagnosis of any disease or condition in humans. Under the terms of the APA,Q32 Purchase Agreement, we (i) made an upfront payment in an amount equal to $7.0 million on the APA Closing Date, (ii) will makemade an additional upfront payment in an amount equal to $3.0 million on the sixth-month anniversary of the APA Closing Date, (iii) will make certain milestone payments upon the achievement of specified development and regulatory milestone events related to AKB-097ebribafusp up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the earlier of initiation of a Phase 2 clinical trial and December 31, 2026, (iv) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the net sales of AKB-097ebribafusp up to an aggregate amount equal to $487.5 million, and (v) will make certain royalty payments based on the net sales of AKB-097ebribafusp with royalty percentage tiers ranging from the low single digits to mid-teen percentages. The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last-to-expire valid claim of any transferred patent right that covers such product in such country, and (b) the tenth anniversary of the first commercial sale of such product.

Our ability to achieve and maintain profitability also depends on our ability to manage our expenses. We expect to continue to incur substantial additional operating expenses, including additional R&D expenses related to our pipeline, including AKB-097,ebribafusp, praliciguat and AKB-9090, and additional R&D and selling, general and administrative expenses for ongoing development, post-marketing requirements and commercialization of Auryxia and Vafseo and any other products, including those that may be in-licensed or acquired, which could lead to operating losses for the foreseeable future. Our prior losses have had, and expected future losses will continue to have, an adverse effect on our stockholders’ equity (deficit) and working capital.

In addition to any further costs not currently contemplated in our operating plan, our ability to achieve and maintain profitability and our financial position will depend, in part, on the rate of our future expenditures, the timing of our product, collaboration,license, licensecollaboration and other revenue, the timing and amount of any repayment of the WCF Royalty Payments, our continued compliance with the terms of the Agreement for the Provision of a Loan Facility, as amended, or the BlackRock Credit Agreement, with Kreos Capital VII (UK) Limited, which are funds and accounts managed by BlackRock Inc., collectively, BlackRock, and our ability to obtain additional funding, shouldif itand bewhen needed. In addition, we expect to continue to incur significant expenses if and as we:

•continue our commercialization activities for Auryxia, Vafseo and any other product or product candidate for which we obtain approval, including those that may be in-licensed or acquired;

•conduct and enroll patients in any clinical trials, including clinical trials for praliciguat, AKB-097ebribafusp and AKB-9090, and post-marketing studies or any other clinical trials for Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired;

•repay, and pay any associated pre-payment penalties, if applicable, the term loans in an aggregate principal amount of $55.0 million, orunder the Termsenior Loans,secured thatterm wereloan made available to usfacility pursuant to the BlackRock Credit Agreement;

•maintain, protect and expand our intellectual property portfolio; and Akebia Therapeutics, Inc. | Form 10-Q | Page 50

•experience any additional delays or encounter issues with any of the above.

We have expended and may in the future expend significant resources on our legal proceedings, as described above under Part III,II, Item 1. Legal Proceedings, including any legal proceedings that may be brought by or against us in the future.

In addition, our ability to generate revenue would be negatively affected if dialysis organizations are unwilling to include or maintain Auryxia or its authorized generic or Vafseo in their formulary or the size of our addressable patient population is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we sought, or the patient population for treatment is narrowed by competition, physician choice, coverage or reimbursement, or payor or treatment guidelines. For example, although we initially sought approval for Vafseo for adult patients with NDD-CKD, the approved indication in the U.S. is limited to the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months. Even though we generate product revenue from AuryxiaAuryxia, its authorized generic and Vafseo in the U.S. and royalties from Riona (ferric citrate hydrate) and Vafseo in Japan, and Vafseo in Europe and other territories where it is approved, and may generate revenue and royalties from the sale of any products that may be approved in the future, including those that may be in-licensed or acquired, we may never generate revenue and royalties that are significant enough for us to become and remain profitable, and we may need to obtain additional financing to continue to fund our operating plan.

We maywill 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.

As of MarchJune 31,30, 2026, our cash and cash equivalents were $162.6$155.5 million. We expect to continue to expend substantial amounts of cash for the foreseeable future as we continue to commercializemanufacture Auryxia for sale in the U.S.; develop and commercialize Vafseo in the U.S.; and develop and commercialize any other product or product candidate, including those that may be in-licensed or acquired. These expenditures will include costs associated with R&D, manufacturing, potentially obtaining marketing approvals and marketing products approved for sale. In addition, other unanticipated costs may arise. Because the outcomes of our current and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of funding necessary to successfully complete clinical development for any current or future product candidates or to complete post-marketing studies for Vafseo. Our future capital requirements depend on many factors, including:

•the scope, progress, results and costs of conducting clinical trials or any post-marketing requirements or any other clinical trials for Auryxia, Vafseo, praliciguat, AKB-097,ebribafusp, AKB-9090, and any other product or product candidate, including those that may be in-licensed or acquired;

•the cost and timing of commercialization activities, including product manufacturing, marketing, sales and distribution costs, for Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired;

•the results of our meetings with the FDA, the EMA and other regulatory authorities with respect to our approved products and product candidates and any consequential effects, including on timing of and ability to obtain and maintain marketing approval, label expansion, study design, study size and resulting operating costs;

•any difficulties or delays in conducting our clinical trials, or enrolling patients in our ongoing or future clinical trials, for Auryxia,Vafseo, Vafseopraliciguat, ebribafusp, AKB-9090 or any other product candidates;

•the timing of, and the costs involved in obtaining, any potential label expansion for Vafseo or marketing approvals for any product candidate, including those that may be in-licensed or acquired, including to fund the preparation, filing and prosecution of regulatory submissions;

•the timing and number of additional generic versions of Auryxia that enter the market following LoE for Auryxia which occurred in March 2025,Auryxia, the availability and pricing of generic versions of Auryxia, the impact of LoE on product revenue from Auryxia, including the impact on the price of Auryxia;

We maywill need to obtain substantial additional financing to fund our business.business and complete development of our product candidates. 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 believe our existing cash resources and the cash we expect to generate from product, royalty, supply and license revenues are sufficient to fund our current operating plan for at least two years,years. includingThis estimate is contingent upon us refinancing our outstanding debt under the senior secured term loan facility to commercializedefer Vafseothe andpayment Auryxiaof andprincipal, advancewhich would otherwise commence on December 31, 2026. If we are unable to refinance our existingsenior programs.secured However,term ifloan, or our operating performance deteriorates significantly from the levels expected in our long-term operating plan, including if we do not achieve our future anticipated Vafseo revenue projections,projections from Vafseo, it would have Akebia Therapeutics, Inc. | Form 10-Q | Page 46 an adverse effect on our liquidity and capital resourcesresources, and couldwe affectwould be required to obtain additional financing to fund our abilityoperating to achieve or maintain profitabilityplan or continue as a going concern in the future. Our forecast of the period of time through which our financial resources will be adequate to support our operationsoperating is a forward-looking statement andplan involves numerous risks and uncertainties, and actual results could vary as a result of a number of factors, many of which are outside our control. We have based this estimate on assumptions that may be substantially different than actual results, and we could utilize our available capital resources sooner than we currently expect.expect or may be unable to refinance our senior secured term loan facility on favorable terms, or at all. In addition, if we fail to satisfy any of the covenants under the BlackRock Credit Agreement, and the loan is accelerated, or if certain pre-specified events occur and we are required to make principal payments to BlackRock sooner than we currently anticipate, such event could have a material adverse effect on our business. There can be no assurance that the current operating plan will be achieved in the time frame anticipated by us, or that our cash resources and cash we expect to generate will fund our operating plan for the period anticipated by us, or that additional funding will be available on terms acceptable to us, or at all.

We expect to finance future cash needs through product revenue and royalty and license revenue, and we may seek to sell public or private equity, enter into new debt transactions, explore potential strategic transactions or a combination of these approaches or other strategic alternatives. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, our fixed payment obligations may increase, any such securities may have rights senior to those of our common stock, and the terms may include liquidation or other preferences and anti-dilution protections that adversely affect the rights of our common stockholders. For example, from September 12, 2024 (the date our shelf registration statement on Form S-3 went effective) through December 31, 2025, we sold 23,708,995 shares of our common stock in an at-the-market offering with gross proceeds of $43.0 million, and during the three and six months ended MarchJune 31,30, 2026, we didsold notan selladditional any3,138,107 shares of our common stock under this program.program with gross proceeds of $3.4 million ($3.2 million, net of offering expenses). Additional debt financing, if available, may involve agreements that would restrict our operations and potentially impair our competitiveness, such as limitations on our ability to incur additional debt, make capital expenditures, declare dividends, acquire, sell or license intellectual property rights, and other operating restrictions that could adversely impact our ability to conduct our business. If we raise additional funds through strategic transactions, we may have to relinquish valuable rights to our portfolio and future revenue streams, and enter into agreements that would restrict our operations and strategic flexibility. If we raise additional funds through strategic transactions with third parties, we may have to do so at an earlier stage than otherwise would be desirable. In connection with any such strategic transactions, we may be required to relinquish valuable rights to our product and product candidates, future revenue streams or research programs or grant licenses on terms that are not favorable to us. If we are unable to raise additional funds when needed, we may not be able to pursue planned development and commercialization activities and we may need to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Although we continue to focus a substantial amount of our efforts to develop and commercialize AuryxiaVafseo and Vafseo,commercialize Auryxia, 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. For example, on November 28, 2025, we acquired AKB-097,ebribafusp, a clinical-stage development candidate with the potential to treat rare kidney diseases. In addition, in January 2026, we announced that the first patient was dosed in a Phase 2 clinical trial of praliciguat and,praliciguat, in April 2026, we announced that the first patient was dosed in a Phase 1 clinical trial of AKB-9090.AKB-9090, and in August 2026, we announced the initiation of a Phase 2 basket trial of ebribafusp.

•the market for a product candidate may be smaller than anticipated or change during our program so that the continued development of that product candidate is no longer commercially reasonable;

Because our internal research capabilities are limited, we may be dependent upon other pharmaceutical and biotechnology companies, academic scientists and institutions, and other researchers to sell or license product candidates, products or technology to us. As a result, our rights to these product candidates may be limited or we may be required to make future payments to such third parties if we are successful in developing such product candidates. For example, under the terms of the Q32 Purchase Agreement, we (i) will make an additional upfront payment to Q32 in an amount equal to $3.0 million on the sixth-month anniversary of the APA Closing Date, (ii) will make certain milestone payments upon the achievement of specified development and regulatory milestone events related to AKB-097ebribafusp up to an aggregate amount equal to $94.5 million, including a $2.0 million development milestone payment upon the earlier of initiation of a Phase 2 clinical trial and December 31, 2026, (iiiii) will make certain milestone payments upon the achievement of specified commercial milestone events with respect to the net sales of AKB-097ebribafusp up to an aggregate amount equal to $487.5 million, and (iviii) will make certain royalty payments based on the net sales of AKB-097ebribafusp with royalty percentage tiers ranging from the low single digits to mid-teen percentages. The success of this strategy depends partly upon our ability to identify, select, and acquire promising product candidates and products. The process of identifying, selecting, negotiating and implementing a license or acquisition of a product candidate or an approved product is lengthy and complex. Other companies, including some with substantially greater financial, marketing and sales resources, may compete with us for the license or acquisition of a product candidate or an approved product. We have limited resources to identify and execute the acquisition or in-licensing of third party products, businesses, and technologies and integrate them into our current infrastructure.

Moreover, we may devote resources to potential acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts, such as with respect to the acquisition of our clinical-stage development candidate AKB-097ebribafusp and the in-license of our clinical-stage development candidate praliciguat. Any product candidate that we acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA, the EMA, the Japanese Pharmaceuticals and Medical Devices Agency, or PMDA, or other regulatory authorities, or post-approval testing or other requirements if approved. All product candidates are prone to risks of failure typical of pharmaceutical product development, including the possibility that a product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot provide assurance that any of Akebia Therapeutics, Inc. | Form 10-Q | Page 48 our products will be manufactured in a cost effective manner, achieve market acceptance or not require substantial post-marketing clinical trials.

As part of our business strategy, we may engage in additional strategic transactions to expand and diversify our portfolio, including through the merger, acquisition or in-license of assets, businesses, or rights to products, product candidates or technologies or through strategic alliances or collaborations, similar to the Keryx Merger and our existing and prior collaboration and license arrangements. We may not identify suitable strategic transactions, or complete such transactions in a timely manner, on favorable terms, on a cost-effective basis, or at all. Moreover, we may devote resources to potential opportunities that are never completed or we may incorrectly judge the value or worth of such opportunities. Even if we successfully execute a strategic transaction, we may not be able to realize the anticipated benefits of such transaction and may experience losses related to our investments in such transactions. Integration of an acquired company or assets into our existing business may not be successful and may disrupt ongoing operations, require the hiring of additional personnel and the implementation and integration of additional internal systems and infrastructure, require the assumption and management of third-party manufacturing relationships for clinical and commercial supply, which could be more expensive or time intensive than we originally anticipate, and require management resources that would otherwise focus on developing our existing business. Even if we are able to achieve the long-term benefits of a strategic transaction, our expenses and short-term costs may increase materially and adversely affect our liquidity. Any of the foregoing could have a detrimental effect on Akebia Therapeutics, Inc. | Form 10-Q | Page 54 our business, results of operations and financial condition. For example, the acquisition of AKB-097ebribafusp on November 28, 2025 is expected to increase research and development expenses and has and will continue to require significant management attention for integration, which could divert resources from other priorities, raise short‑term costs, and adversely affect our liquidity. In addition, onpursuant Juneto 4,our 2021, we entered into aamended license agreement, or the Cyclerion Agreement,agreement with Cyclerion Therapeutics Inc.,Inc. orwe Cyclerion, pursuant to which Cyclerionwere granted us an exclusive global license under certain intellectual property rights to research, develop and commercialize praliciguat, an investigational oral, once-daily soluble guanylate cyclase stimulator being evaluated for the treatment of biopsy-confirmed focal segmental glomerulosclerosis, a rare kidney disease, with plans to assess its use in other rare podocytopathies in the future. In December 2024, we entered into an amendment to the Cyclerion Agreement and we nowcurrently control all clinical and commercial manufacturing of praliciguat, which will be conducted by a third-party manufacturer. Although we needed to doperformed additional work to manufacture product for clinical trials than originally anticipated before we could initiate the trial for praliciguat, on January 6, 2026, we announced that the first patient was dosed in a Phase 2 clinical trial in the U.S. However, even though the clinical trial has started, we may be unsuccessful in developing praliciguat. If any of the assumptions that we made in valuing the transactions, including the costs or timing of development of AKB-097,ebribafusp or praliciguat or AKB-9090,, or the potential benefits of AKB-097, praliciguatebribafusp or AKB-9090,praliciguat, were incorrect, we may not recognize the anticipated benefits of the transactions and our business could be harmed.

We entered into the BlackRock Credit Agreement, which provides for a senior secured term loan facility, in the aggregate principal amount of $55.0 million, or the Term Loan Facility. The initial tranche of $37.0 million, or the Tranche A Loan,million closed on January 29, 2024, or the Closing Date, an additional amount of $8.0 million, or the Tranche B Loan,million was drawn on April 19, 2024, and an additional $10.0 million was drawn on February 3, 2025, or the Tranche C Loan and, together with the Tranche A Loan and the Tranche B Loan, the Term Loans.2025. See Note 7, Indebtedness, to our unaudited condensed consolidated financial statements in Part I, Item 1. Financial Statements of this Form 10-Q for additional information regarding our obligations under the BlackRock Credit Agreement. The Term Loan Facility has a maturity date of January 29, 2028, or the Maturity Date.

The Term Loan Facility accrues interest at a floating annual rate equal to the sum of (x) term Secured Overnight Financing Rate for a tenor of one month (subject to a floor of 4.25% per annum) plus (y) a margin of 6.75% per annum (subject to an overall cap of 15.00% per annum on the all-in interest rate). During the continuance of any payment event of default under the BlackRock Credit Agreement, the interest rate on such overdue sum will automatically increase by an additional 3.0% per annum, and may be subject to an additional late fee of 2.0% of such overdue sum. The Term Loan Facility does not amortize during the period commencing on theJanuary Closing29, Date2024 and ending on December 31, 2026 (as extended at our option), or the Interest Only Period. We are required to pay interest and, after the Interest Only Period, principal on the first calendar day of each month. In the event of certain prespecified events, the repayment schedule will be accelerated. If any of these events occur, and we are required to repay principal sooner than we anticipate, it would have an adverse effect on our business. We are currently evaluating options to refinance the outstanding debt under the Term Loan Facility, including to defer the timing of payment of principal; however, there can be no assurance that we will be successful in refinancing the Term Loan Facility in a timely manner, on favorable terms, or at all, which could have an adverse impact on our business, financial condition and results of operations.

Our business and our ability to generate product revenue largely depend on our, and our collaborators’, ability to successfully commercialize Auryxia and Vafseo. Our ability to generate revenue depends on our ability to execute on our commercialization plans, and the size of the market for, and the level of market acceptance of, Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired. If we are not able to maintain contracts Akebia Therapeutics, Inc. | Form 10-Q | Page 56 with dialysis organizations and other customers for the sale of Auryxia and Vafseo on favorable terms, or at all, our revenue and results of operations will be adversely affected. If the size of any market for which a product or product candidate is approved decreases or is smaller than we anticipate, our revenue and results of operations could be materially adversely affected. For example, the approval for Vafseo in the U.S. is limited to the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months instead of all such adults. This limitation could affect the level of market acceptance of Vafseo.

We had exclusive rights under a series of patents and patent applications to commercialize Auryxia in the U.S. that protected us from generic drug competition until March 20, 2025. Following LoE, the number of generic versions of Auryxia that enter the market, and the timing thereof, have and will continue to adversely affect our revenue from Auryxia. On February 5, 2025, we entered into an Authorized Generic Distribution and Supply Agreement with Mylan Pharmaceuticals, Inc., orour AG Distributor, as amended in September 2025, pursuant to which, since March 20, 2025, theyour haveAG Distributor has been selling an authorized generic version of Auryxia. On March 11, 2026, Teva Pharmaceuticals Ltd., or Teva, received approval for its Abbreviated New Drug Application, or ANDA,ANDA for a generic version of Auryxia,Auryxia. whichAs hasa subsequentlyresult entered the market. We expectof Teva's entry into the market, we have experienced, and we expect to continue to experience, a significant reduction in the entryvolume of Auryxia sales. We expect the ongoing sales of generic versions of Auryxia, including by Teva and our AG Distributor, and of any additional generic versions of Auryxia that may be approvedapproved, inwill additioncontinue to ourhave AGa Distributor,significant will adverselyadverse impact on our revenue. However, the extent of the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations,organizations on favorable terms, or at all, the timing and number of additional generics, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

Given the concentration of dialysis clinics in large networks, with DaVita, Inc., or DaVita, Fresenius Kidney Care Group LLC, or Fresenius, and U.S. Renal Care, or USRC, accountingaccount for a vast majority of the dialysis population in the U.S.,U.S. As a result of this concentration of dialysis facilities in large networks, treatment is usually driven by medical protocols that are implemented across the entire network of clinics. Dialysis organizations require large data sets to adopt medical protocols and often have lengthy processes to implement and operationalize the protocol and make the new therapy available for patients. For example, to date, Fresenius does not have a medical protocol in place for Vafseo but may allow for its use through a medical exception process. If Fresenius does not add Vafseo to its medical protocol or if the protocol services smaller populations than the current label, Vafseo may not become standard of care nor achieve the level of market acceptance we anticipate. In addition, some dialysis organizations have medical protocols that require specific steps once Vafseo is prescribed that lengthens the time before the patient starts treatment, delaying initial adoption. Once a dialysis organization has added a new therapy to its medical protocol, implementation in dialysis clinics requires changes to these dialysis organizations' formularies, administration methods and operational practices, as well as gaining acceptance from healthcare professionals. If dialysis organizations do not add Vafseo to their medical protocolsprotocol or if dialysis organizations that currently have a protocol in a timely manner, or at all, orplace do not keep Vafseo on their medical protocols, or maintain protocols that delay treatment initiation by requiring additional steps, or if the protocols service smaller populations than the current label, Vafseo may not achieve standard of care and our results of operations could be materially adversely affected. For example, inalthough theVafseo yearhas endedbeen Decemberadded 2025,to most dialysis organizations' protocols, physicians initiating and, in some cases, maintaining, patients on therapy within the highly protocolized dialysis environment tookhas been taking longer than we expected. In 2025 and in the quartersix months ended MarchJune 31,30, 2026, most Vafseo revenue was driven by mid-sized dialysis organizations. If we are unable to increase sales to the large dialysis organizations and other medium-sized dialysis organizations, our results of operations will be negatively impacted. Furthermore, as a result of changes in the amount of reimbursement dialysis facilities will receive for use of Vafseo when Vafseo transitions from the Transitional Drug Add-on Payment Adjustment, or TDAPA, period to the post-TDAPA period beginning in January 2027, we expect to price Vafseo within the range of the price for erythropoiesis stimulating agents, or ESAs. ESAs are currently priced significantly lower than Vafseo’s current price. As a result, while we expect to sell a higher unit volume of Vafseo in 2027 as compared to 2026, we expect Vafseo revenues to decrease significantly in 2027 as compared to 2026 due to the expected lower price point. Further, we believe competition has increased pricing pressures for ESAs, which may negatively impact the price of, and the market for, Vafseo in the post-TDAPA period. For more information, see the risk factor entitled "Our, or our partners', failure to obtain or maintain adequate coverage, pricing and reimbursement for Auryxia or Vafseo after the TDAPA period in the U.S., or for Auryxia and Vafseo outside the U.S., or for any other future approved products, could have a material adverse effect on our or our collaboration partners’ ability to sell such approved products profitably and otherwise have a material adverse impact on our business."

We have established the Company as a leader in the kidney community and believe our cross-organizational expertise in kidney disease positions us for success. Chronic kidney disease, or CKD, is a condition in which the kidneys are progressively damaged to the point that they cannot properly filter the blood circulating in the body. This damage causes waste products to build up in the patient’s blood, leading to other health problems, including anemia, cardiovascular disease and bone disease. CKD significantly impacts the United States, or U.S., healthcare system, potentially affecting approximately 35.5 million patients. In 2022, in the U.S. treating Medicare beneficiaries with CKD cost an estimated $95.7 billion, and treating people on dialysis cost an estimated $45.3 billion. Our two commercial products address certain complications of kidney disease.

Vafseo® (vadadustat) is an orally administered medicine that was approved by the U.S. Food and Drug Administration, or the FDA, in March 2024 for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. The current U.S. market opportunity for the treatment of anemia due to CKD in patients with dialysis is approximately $1 billion based on current erythropoiesis stimulating agent, or ESA, pricing. Vafseo is the only oral hypoxia inducible factor, or HIF, based treatment available in the U.S. Vafseo entered the market in January 2025, at which time we had commercial supply agreements for the purchase of Vafseo in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S. Throughout 2025, we worked closely with dialysis organizations as their medical teams developed, implemented and operationalized protocols to enable prescribers to write Vafseo prescriptions for clinically appropriate patients. Currently, approximately 290,000 dialysis patients in the U.S. have prescribing access to Vafseo.2025.

Our mid-stage rare kidney disease pipeline assets, praliciguat and AKB-097,ebribafusp, are being evaluated to target areas of unmet need. In June 2021, we licensed praliciguat from Cyclerion Therapeutics, Inc., or Cyclerion, via an exclusive global license, which includes certain intellectual property rights to research, develop and commercialize the asset. Praliciguat is an oral, once-daily soluble guanylate cyclase, or sGC, stimulator. We are evaluating praliciguat for the treatment of biopsy-confirmed focal segmental glomerulosclerosis, or FSGS, a rare kidney disease, in a Phase 2 clinical trial. The first patient was dosed in this trial in December 2025. We also plan to assess the use of praliciguat in other rare podocytopathies in the future.

In November 2025, we entered into an asset purchase agreement with Q32 Bio Inc. and Q32 Bio Operations Inc., together Q32, pursuant to which we purchased and assumed substantially all assets and liabilities of Q32 and its affiliates related to the research, development, manufacture and commercialization of Q32’s clinical-stage development candidate ADX-097, known as ADX-097ebribafusp (now referred to as AKB-097, generic name ebribafuspAKB-097), an anti-C3d-Factor H fusion protein complement inhibitor. AKB-097Ebribafusp is a potential next-generation complement inhibitor, and we believe AKB-097ebribafusp has applicability across a wide range of complement-mediated rare kidney diseases. AKB-097Ebribafusp is intended to provide targeted regulation of complement activation at sites of tissue injury while limiting systemic complement inhibition. WeIn expectAugust toAkebia initiateTherapeutics, Inc. | Form 10-Q | Page 33 2026, we announced the initiation of a Phase 2 basket study in the second half of 2026 to evaluate AKB-097ebribafusp for the following indications:in IgA Nephropathy, or IgAN;IgAN, C3 Glomerulopathy, or C3G;C3G, and Lupus Nephritis, or LN.

We generate product revenue from commercial sales of Auryxia and Vafseo to a limited number of customers, including dialysis organizations, wholesale distributors, certain specialty pharmacy providers and our authorized generic distribution partner,partner for Auryxia, Mylan Therapeutics, Inc., or AG Distributor. Our net product revenue includes many variables, including judgments and estimates of discounts, rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year.

We expect to continue to generate revenue from our collaboration,license, licensecollaboration and supply agreements with MEDICE Arzneimittel Pütter GmbH & Co. KG, or Medice, Tanabe Pharma Corporation, or TPC, Japan Tobacco, Inc., and its subsidiary, Torii Pharmaceutical Co., Ltd., collectively, JT and ToriiTorii, and any other collaborations into which we have entered or may enter.

Cost of product and other revenue includes costs closely correlated or directly related to the costs to manufacture commercial drug substance and drug product, including at our contract development and manufacturing organizations, or CMOs,CDMOs, as well as indirect costs. Direct and indirect costs include fees for packaging, shipping, insurance and quality assurance, idle capacity charges, changes in reserves for excess inventory, write-offs for inventory that fails to meet specifications or is otherwise no longer suitable for commercial sale, including scrap, changes in a firm purchase commitment liability and royalties due to the licensor of Auryxia related to U.S. and Japan product sales recognized during the period.

Cost of product and other revenue for a newly launched product does not include the full cost of manufacturing until the initial pre-launch inventory is depleted and additional inventory is manufactured and sold. Until we received regulatory Akebia Therapeutics, Inc. | Form 10-Q | Page 31 approval for Vafseo in the U.S., we recorded costs incurred to manufacture the U.S. pre-launch inventory, such as raw materials, drug substance and drug product conversion costs as research and development, or R&D, expense.

•the cost of acquiring, developing and manufacturing clinical trial materials through CMOsCDMOs;

•acquired in process research and development costs associated with the acquisition of Q32's clinical stage development asset now referred toknown as AKB-097ebribafusp; and

From inception through MarchJune 31,30, 2026, we have incurred $1.8 billion in R&D expenses. We expect to incur significant R&D expenditures for the foreseeable future as we continue the development of Auryxia, Vafseo, praliciguat, AKB-097,ebribafusp, AKB-9090 and any other product or product candidate, including those that may be in-licensed or acquired.

A significant portion of our R&D costs have been external costs, which we track on a program-by-program basis as well as costs related to possible new manufacturing processes and methods associated with our commercial products. These external costs include fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials and costs related to acquiring and manufacturing clinical trial materials, including costs paid to CMOsCDMOs to manufacture clinical trial materials.

Each of our products and product candidates has technical, clinical, regulatory, and commercial risk, including those discussed more fully under the heading “Risk Factors” in Part II, Item 1A of this Form 10-Q. A change in the outcome of any of the variables with respect to the development of Auryxia,Vafseo, Vafseopraliciguat, orebribafusp and AKB-9090 and any other product or product candidatecandidate, could result in a significant change in the costs and timing associated with that development.

Change in fair value of warrant liability relates to the change in fair value of our warrant liability related to a warrant agreement with Kreos Capital VII Aggregator SCSp, an affiliate of Kreos Capital VII (UK) Limited, or Kreos. See Note 3, Fair Akebia Therapeutics, Inc. | Form 10-Q | Page 35 Value Measurements, and Note 7, Indebtedness, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the warrant liability.

On April 9, 2026, the Companywe extended the term of our lease for office and laboratory space in Cambridge, Massachusetts, or the Cambridge LeaseLease, with respect to the laboratory space from September 11, 2026 to October 31, 2026. See Note 7,9, SubsequentLeases, Events,in the accompanying notes to the consolidated financial statements included in Part I, Item 1 of this Form 10-Q for further information on the Cambridge Lease.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Net product revenue was $52.0$46.8 million for the three months ended MarchJune 31,30, 2026, compared to $55.8$60.5 million for the three months ended MarchJune 31,30, 2025. The decrease was primarily due to lower Auryxia revenues, which were partially offset by higher Vafseo revenues.

Following LoE for Auryxia lost exclusivity in the U.S. in March 2025, which we expect to have a negative impact on future Auryxia revenue. Following LoE, our AG Distributor has been selling an authorized generic version of Auryxia in the U.S. On March 11, 2026, Teva received approval for its ANDA for a generic version of Auryxia,Auryxia. whichAs hasa subsequentlyresult entered the market. We expectof Teva's entry into the market, we have experienced, and we expect to continue to experience, a significant reduction in the entryvolume of Auryxia sales. We expect the ongoing sales of generic versions of Auryxia, including by Teva and our AG Distributor, and of any additional generic versions of Auryxia that may be approvedapproved, inwill additioncontinue to ourhave AGa Distributor,significant will adverselyadverse impact on our revenue. However, the extent of the impact on future Auryxia revenues will depend on many factors, including our ability to maintain contracts with dialysis organizations,organizations on favorable terms, or at all, the timing and number of additional generics that enter the market,generics, the amount of generic product available to supply the market and the pricing of generics and other products on the market that compete with Auryxia.

The following table summarizes our product revenue by product for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

(1) Includes the authorized generic version of Auryxia sold and distributed by our AG Distributor during the three months ended MarchJune 31,30, 2026 and 2025.

License, Collaboration and Other Revenue—License, collaboration and other revenue was $1.6$2.4 million for the three months ended MarchJune 31,30, 2026, compared to $1.5$2.0 million for the three months ended MarchJune 31,30, 2025. The increase was primarily due to revenue recognized in connection with our supply agreement with Medice during the three months ended June 30, 2026.

Cost of Goods Sold—Cost of Product and Other Revenue—Cost of product and other revenue was $12.3$10.4 million for the three months ended MarchJune 31,30, 2026 compared to $7.6$9.9 million for the three months ended MarchJune 31,30, 2025. The increase was primarily due to an increase in inventory write-downs as a result of excess, obsolescence, scrap or other reasons during the three months ended MarchJune 31,30, 2026.

We began capitalizing our Vafseo costs in March 2024, in connection with the FDA's approval of Vafseo for the treatment of anemia due to CKD in adult patients on dialysis for at least three months. Prior to the capitalization of Vafseo inventory costs, such costs were recorded as research and development expenses in the period incurred. Cost of product and other revenue for Vafseo was $1.4$1.0 million for the three months ended MarchJune 31,30, 2026, comprised of manufacturing and overhead costs as the associated inventory costs such as raw materials, drug substance and drug product conversion costs were expensed previously. If Vafseo inventory sold during the three months ended MarchJune 31,30, 2026 was valued at cost, our cost of product and other revenue would have been $6.2$3.5 million. As of MarchJune 31,30, 2026, we had $24.6$18.2 million of reduced-cost Vafseo inventory. We expect our cost of product and other revenue for Vafseo will increase, reflecting the full cost of manufacturing, subsequent to the utilization of our reduced-cost Vafseo inventory.

R&D Expenses—R&D expenses were $14.8$14.1 million for the three months ended MarchJune 31,30, 2026, compared to $9.8$11.0 million for the three months ended MarchJune 31,30, 2025. The increase was primarily driven by increased clinical trial activities related to our mid-stage pipeline assets, which include praliciguat and AKB-9090ebribafusp, as well as higher headcount related costs during the three months ended MarchJune 31,30, 2026.

The following table summarizes our external research and development expenses by program, as well as costs not allocated to programs, for the three months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Selling, General and Administrative Expenses—Selling, general and administrative expenses were $30.4$28.2 million for the three months ended MarchJune 31,30, 2026, compared to $25.7$26.6 million for the three months ended MarchJune 31,30, 2025. The increase was driven by higherincreased headcountcommercialization related costs during the three months ended March 31, 2026.activities.

Other Expense, Net—Other expense, net, was $4.7$3.1 million for the three months ended MarchJune 31,30, 2026, compared to $7.6$6.9 million for the three months ended MarchJune 31,30, 2025. The decrease was primarily due to lower non-cash interest expense related to the settlement royalty liability in connection with athe Termination and Settlement Agreement with CSL Vifor, or the Vifor Termination Agreement, as well as higher interest income related to our money market funds. See Note 8, Liability Related to Settlement Royalties, Working Capital Fund Liability and Liability Related to Sale of Future Royalties, included in the accompanying notes to the unaudited condensed consolidated financial statements in Part I, Item 1 of this Form 10-Q for further information.

Change in Fair Value of Warrant Liability—Change in fair value of warrant liability was $0.5$0.6 million and $0.2$7.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively.

Income Tax Expense—Income tax expense was $0.1 million for the three months ended MarchJune 31,30, 2026. There was no income tax expense for the three months ended MarchJune 31,30, 2025.