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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.
−Removed: 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 the foreseeable future, including to commercialize Vafseo and Auryxia, pursue label expansion for Vafseo, and advance our other existing programs.
−Removed: However, we have incurred net losses each year since our inception, and although we generated net income of $0.2 million and $6.4 million for the three and six months ended June 30, 2025, respectively, we cannot guarantee when, if ever, we will become and remain profitable.
−Removed: As of June 30, 2025, we had an accumulated deficit of $1.7 billion.
−Removed: In March 2022, we received a complete response letter, or CRL , from the United States, or U.S.
−Removed: , Food and Drug Administration, or FDA , regarding our new drug application, or NDA , for vadadustat for the treatment of anemia associated with chronic kidney disease, or CKD .
−Removed: Following a Formal Dispute Resolution Request, or FDRR , to the FDA in 2022 for
+Added: 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 the foreseeable future, including to commercialize Vafseo and Auryxia and advance our existing programs.
+Added: However, we have incurred net losses each year since our inception, and although we generated net income of $0.5 million and $6.9 million for the three and nine months ended September 30, 2025, respectively, we cannot guarantee when, if ever, we will become and remain profitable.
+Added: As of September 30, 2025, we had an accumulated deficit of $1.7 billion.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 46
−Removed: vadadustat, we filed a resubmission to our NDA in 2023.
+Added: In March 2022, we received a complete response letter, or CRL , from the United States, or U.S.
+Added: , Food and Drug Administration, or FDA , regarding our new drug application, or NDA , for vadadustat for the treatment of anemia associated with chronic kidney disease, or CKD .
+Added: 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 CKD in adults who have been receiving dialysis for at least three months.
5 unchanged sentences
• maintaining marketing approvals for Auryxia, Vafseo and any other product, including those that may be in-licensed or acquired;
−Removed: • obtaining regulatory approval for any label expansion for Vafseo, including the timing and scope thereof;
+Added: • obtaining regulatory approval for any potential label expansion for Vafseo, including the timing and scope thereof;
• our ability to maintain contracts with dialysis organizations for the sale of Auryxia and Vafseo in the U.S.;
2 unchanged sentences
• the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies, based, in part, on their perception of our clinical trial data and/or the actual or perceived safety, tolerability and efficacy profile;
+Added: • patients’ adherence or non-adherence to the prescribed treatment regimen;
• the timing and scope of marketing approvals for any product candidate, if approved, including those that may be in-licensed or acquired;
1 unchanged sentence
• 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 , 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;
+Added: • maintaining adequate inventory levels of Auryxia, Vafseo and any other products or product candidates;
• the potential impact of geopolitical pressures, including tariffs and global trade policies, or the BIOSECURE Act on our ability to conduct our business as currently conducted;
3 unchanged sentences
• maintaining, protecting and expanding our portfolio of intellectual property rights, including patents and trade secrets.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 47
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.
2 unchanged sentences
Vafseo is currently marketed and sold by Medice in certain countries in the Medice Territory.
−Removed: If Medice’s launch of Vafseo in certain
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 46
−Removed: 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.
+Added: 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.
In July 2024, we entered into a Termination and Settlement Agreement with CSL Vifor, or the Vifor Termination Agreement .
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• 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;
−Removed: • seek regulatory approval for any label expansion for Vafseo;
+Added: • seek regulatory approval for any potential label expansion for Vafseo;
• conduct and enroll patients in any clinical trials, including 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;
2 unchanged sentences
• manufacture Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired, for commercial sale and clinical trials;
−Removed: • conduct discovery and development activities for additional product candidates or platforms that may lead to the discovery of additional product candidates;
−Removed: • engage in transactions, including strategic, merger, collaboration, acquisition and licensing transactions, pursuant to which we would market and develop commercial products, or develop and commercialize other product candidates and technologies;
Akebia Therapeutics, Inc.
| Form 10-Q | Page 48
+Added: • secure and validate manufacturing facilities for any of our products and product candidates;
+Added: • conduct discovery and development activities for our products and product candidates or platforms that may lead to the discovery of additional product candidates;
+Added: • engage in transactions, including strategic, merger, collaboration, acquisition and licensing transactions, pursuant to which we would market and develop commercial products, or develop and commercialize other product candidates and technologies;
• repay, and pay any associated pre-payment penalties, if applicable, the term loans in an aggregate principal amount of $55.0 million, or the Term Loans , that were made available to us pursuant to the BlackRock Credit Agreement ;
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Legal Proceedings, including any legal proceedings that may be brought by or against us in the future.
−Removed: 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 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.
+Added: 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.
−Removed: The net losses we incur may 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.
+Added: Any net losses we may incur in 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.
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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.
−Removed: As of June 30, 2025, our cash and cash equivalents were $137.3 million.
+Added: As of September 30, 2025, our cash and cash equivalents were $166.4 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.;
6 unchanged sentences
• the scope, progress, results and costs of conducting clinical trials or any post-marketing requirements or any other clinical trials for Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired;
−Removed: • 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;
−Removed: • the results of our meetings with the FDA, the EMA and other regulatory authorities 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;
Akebia Therapeutics, Inc.
| Form 10-Q | Page 49
+Added: • 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;
+Added: • the results of our meetings with the FDA, the EMA and other regulatory authorities 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 clinical trials, for Auryxia, Vafseo or any other product candidates;
• the outcome of our efforts to obtain marketing approval for any product candidates, including those that may be in-licensed or acquired, including any additional clinical trials or post-approval commitments imposed by regulatory authorities;
−Removed: • the timing of, and the costs involved in obtaining, 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;
+Added: • 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 costs of maintaining marketing approvals for Auryxia, Vafseo or any other product, including those that may be in-licensed or acquired;
• the timing and number of additional generic versions of Auryxia that enter the market following LoE for Auryxia which occurred in March 2025, the pricing of generic versions of Auryxia, the impact of the LoE on product revenue from Auryxia, including the impact on the price of Auryxia;
−Removed: • the cost of securing and validating commercial manufacturing 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 or product candidate, including those that may be in-licensed or acquired, or securing and validating additional arrangements;
+Added: • the cost of securing and validating manufacturing facilities 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 or product candidate, including those that may be in-licensed or acquired, or securing and validating additional arrangements;
• the costs involved in preparing, filing and prosecuting patent applications and maintaining, defending and enforcing our intellectual property rights, including litigation costs and the outcome of such litigation;
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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.
−Removed: 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 the foreseeable future, including to commercialize Vafseo and Auryxia, pursue label expansion for Vafseo and advance our other existing programs.
−Removed: However, if our operating performance deteriorates significantly from the levels expected in our long-term operating plan, 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.
+Added: 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 the foreseeable future, including to commercialize Vafseo and Auryxia and advance our existing programs.
+Added: 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.
4 unchanged sentences
Also, additional funds may not be available to us in sufficient amounts or on acceptable terms or at all.
−Removed: In addition, raising funds in the current economic environment may present additional challenges.
−Removed: 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, the Russia-Ukraine war, the Israel-Hamas war and the war in the Middle East and tensions between China and Taiwan, could negatively impact our ability to raise capital, and we cannot predict the extent or duration of such macroeconomic disruptions.
−Removed: 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
+Added: In addition, raising funds in the current economic environment may present additional
Akebia Therapeutics, Inc.
| Form 10-Q | Page 50
−Removed: development and/or commercialization of Auryxia, Vafseo and any other products or product candidates, including those that may be in-licensed or acquired.
+Added: 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, hostilities between Israel and Hamas, instability in the Middle East, tensions between China and 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.
+Added: 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.
2 unchanged sentences
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.
−Removed: For example, since 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 six months ended June 30, 2025, we sold 9,437,364 shares of our common stock under this program with gross proceeds of $18.7 million.
+Added: For example, from 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 nine months ended September 30, 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.
14 unchanged sentences
• the market for a product candidate may change during our program so that the continued development of that product candidate is no longer commercially reasonable;
−Removed: • a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
−Removed: • a product candidate may not be accepted as safe and effective by patients, the medical community, or third party payors, if applicable.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 51
+Added: • a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
+Added: • a product candidate may not be accepted as safe and effective by patients, the medical community, or third party payors, if applicable.
If any of these events occur, we may be forced to abandon our R&D efforts for one or more of our programs, or we may not be able to identify, discover, develop or commercialize additional product candidates, including those that may be in-licensed or acquired, which may have a material adverse effect on our business.
24 unchanged sentences
Any of the foregoing could have a detrimental effect on our business, results of operations and financial condition.
−Removed: For example, 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 oral soluble guanylate cyclase stimulator.
−Removed: In December 2024, we entered into an amendment to the Cyclerion Agreement and we now control all clinical and commercial manufacturing of praliciguat, which will be conducted by a third-party manufacturer.
−Removed: Although we have progressed preclinical studies for praliciguat, we needed to do additional work to manufacture product for clinical trials than originally anticipated before we could initiate the trials,
+Added: For example, 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
Akebia Therapeutics, Inc.
| Form 10-Q | Page 52
−Removed: and when the clinical trials are started, we may be unsuccessful in developing praliciguat.
+Added: commercialize praliciguat, an investigational oral soluble guanylate cyclase stimulator.
+Added: In December 2024, we entered into an amendment to the Cyclerion Agreement and we now control all clinical and commercial manufacturing of praliciguat, which will be conducted by a third-party manufacturer.
+Added: Although we have progressed preclinical studies for praliciguat, we needed to do additional work to manufacture product for clinical trials than originally anticipated before we could initiate the trials, and when the clinical trials are started, we may be unsuccessful in developing praliciguat.
If any of the assumptions that we made in valuing the transaction, including the costs or timing of development of praliciguat as a result of the additional manufacturing work or otherwise, or the potential benefits of praliciguat, were incorrect, we may not recognize the anticipated benefits of the transaction and our business could be harmed.
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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.
−Removed: The Term Loan Facility does not amortize during the period commencing on the Closing Date and ending on December 31, 2026 (as extended at our option), or the Interest Only Period .
+Added: The Term Loan Facility does not amortize during the period commencing on the Closing Date and ending on December 31, 2026 (as extended at our option), or the
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 53
+Added: Interest Only Period .
We are required to pay interest and, after the Interest Only Period, principal on the first calendar day of each month.
1 unchanged sentence
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.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 52
In the event there is an acceleration of our and certain of our subsidiaries’ liabilities under the BlackRock Credit Agreement as a result of an event of default or otherwise, we may not have sufficient funds or may be unable to arrange for additional financing to repay the liabilities or to make any accelerated payments, and BlackRock could seek to enforce security interests in the collateral securing the BlackRock Credit Agreement, which would have a material adverse effect on our business, financial condition and results of operations.
24 unchanged sentences
Following LoE, the number of generic versions of Auryxia that enter the market, and the timing thereof, will adversely affect our revenue from Auryxia.
−Removed: On February 5, 2025, we entered into an Authorized Generic Distribution and Supply Agreement with Mylan Pharmaceuticals, Inc., or AG Partner , pursuant to which, since March 20, 2025, they have been selling an authorized generic version of Auryxia.
−Removed: Currently, no additional generics of Auryxia have entered the market, but the FDA could approve another generic at any time.
−Removed: The 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.
+Added: On February 5, 2025, we entered into an Authorized Generic Distribution and Supply Agreement with Mylan Pharmaceuticals, Inc., or AG Partner , pursuant to which,
Akebia Therapeutics, Inc.
| Form 10-Q | Page 54
−Removed: Auryxia sales decline faster than we anticipate following LoE, our results of operations and financial condition will be materially harmed.
+Added: since March 20, 2025, they have been selling an authorized generic version of Auryxia.
+Added: Currently, no additional generics of Auryxia have entered the market, but the FDA could approve another generic at any time.
+Added: The 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.
+Added: 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.
1 unchanged sentence
Dialysis organizations require large data sets to adopt medical protocols.
−Removed: If dialysis organizations do not add Vafseo to their medical protocols in a timely manner, or at all, or do not keep Vafseo on their medical protocols, or if the protocols service smaller populations than the current label, our results of operations could be materially adversely affected.
−Removed: For example, in the quarter ended June 30, 2025, most Vafseo revenue was driven by mid-sized dialysis organizations.
+Added: 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.
+Added: If dialysis organizations do not add Vafseo to their medical protocols in a timely manner, or at all, or 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, our results of operations could be materially adversely affected.
+Added: In the quarter ended September 30, 2025, most Vafseo revenue was driven by mid-sized dialysis organizations.
If we are unable to increase sales to the large and small dialysis organizations, our results of operations will be negatively impacted.
−Removed: 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, however, it will take time for dialysis organizations to implement internal mechanisms to dispense phosphate binders which could negatively impact the market for phosphate binders, including Auryxia, and divert dialysis organizations' attention from focusing on other therapeutic areas such as anemia management, which in turn could negatively impact the market for Vafseo.
+Added: 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.
3 unchanged sentences
We believe this and potentially other factors, led to the reduction in the phosphate binder market, which has not experienced growth since early 2020.
−Removed: While we are unable to quantify the impact of the COVID-19 pandemic on future Auryxia revenues and revenue growth, the COVID-19 pandemic and the ongoing impacts from the COVID-19 pandemic continue to adversely and disproportionately impact CKD patients and the phosphate binder market.
+Added: While we are unable to quantify the impact of the COVID-19 pandemic on future Auryxia revenues and revenue growth, ongoing impacts from the COVID-19 pandemic continue to adversely and disproportionately impact CKD patients and the phosphate binder market.
Therefore, we expect the impacts from the pandemic to continue to have a negative impact on our Auryxia revenue growth for the foreseeable future.
2 unchanged sentences
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.
+Added: For example, an unexpected number of patients initially prescribed Vafseo have discontinued treatment.
+Added: 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:
• the availability of adequate coverage and reimbursement by, and the availability of discounts, rebates and price concessions to dialysis organizations, third party payors, pharmacy benefit managers, or PBMs , and governmental authorities;
−Removed: • the availability of discounts and rebates to dialysis organizations to facilitate access for patients;
• use at dialysis organizations and their willingness to include or continue to include Auryxia or Vafseo in their formulary or protocols and the scope of such protocols;
20 unchanged sentences
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.
−Removed: In addition, our net product revenue requires judgement and includes estimates for rebates and product returns, which can fluctuate from quarter-to-quarter and year-over-year.
+Added: In addition, our net product revenue requires judgment 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.
−Removed: Several healthcare facilities, including DaVita, have previously restricted access for non-patients as a result of the COVID-19 pandemic, resulting in restricted access for certain members of our sales force.
−Removed: Such precautionary measures have since been relaxed at certain healthcare facilities and, as a result, members of our sales force have resumed in person interactions with those customers.
−Removed: Nevertheless, some restrictions remain and restrictions on our customer-facing employees’ in-person interactions with healthcare providers have, and could continue to, negatively impact our access to healthcare providers and ultimately our sales, including with respect to Vafseo.
−Removed: In addition, restrictions on access to healthcare providers and patients could be imposed in the future due to a resurgence in COVID-19 cases, including from more contagious or severe variants, or from outbreaks of other infectious diseases, which could result in declines or changes in prescription trends and customer orders, and which could have a material adverse effect on our business, results of operations, and financial condition.
If we are unable to maintain sales and marketing capabilities or enter into or maintain agreements with third parties, we may not be successful in commercializing Auryxia, Vafseo or any other product candidates that may be approved.
3 unchanged sentences
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.
+Added: For example, certain restrictions on access for members of our sales force to dialysis organizations have negatively impacted, and may continue to negatively impact, our ability to market Vafseo to healthcare providers, which could ultimately affect our sales of Vafseo.
+Added: Furthermore, additional restrictions on access to healthcare providers could be imposed in the future, including as a result of outbreaks of infectious diseases.
+Added: Such restrictions could result in slower adoption of Vafseo, declines or changes in prescription trends and customer orders, and could have a material adverse effect on our business, results of operations, and 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.
9 unchanged sentences
I f we are unable to maintain our own sales and marketing capabilities, we will not be successful in commercializing Auryxia, Vafseo and any other product candidate that may be approved.
−Removed: Also, if we are unable to maintain our arrangements with third parties with respect to sales and marketing, if we are unsuccessful in entering into additional arrangements with third parties to sell and market our products or we are unable to do so on terms that are favorable to us, or if such third parties are
+Added: Also, if we are unable to maintain our arrangements with third parties with respect to sales and marketing, if we are unsuccessful in entering into additional arrangements with third parties to sell and market our products or we are unable to do so on terms that are favorable to us, or if such third parties are unable to carry out their obligations under such arrangements, it will be difficult to successfully commercialize our product and product candidates, including Vafseo.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 56
−Removed: unable to carry out their obligations under such arrangements, it will be difficult to successfully commercialize our product and product candidates, including Vafseo.
Our, or our partners', failure to obtain or maintain adequate coverage, pricing and reimbursement for Auryxia, Vafseo or 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.
−Removed: Market acceptance and sales of any approved products, including Auryxia and Vafseo, depends significantly on the availability of adequate coverage and reimbursement from third party payors and may be affected by existing and future healthcare reform measures.
+Added: Market acceptance and sales of any approved products, including Auryxia and Vafseo, depend significantly on the availability of adequate coverage and reimbursement from third party payors and may be affected by existing and future healthcare reform measures.
Governmental authorities, dialysis organizations, third party payors, and PBMs decide which drugs they will cover, as well as establish formularies or implement other mechanisms to manage utilization of products and determine reimbursement levels.
26 unchanged sentences
CMS had earlier filed a motion to dismiss the complaint on jurisdictional grounds.
−Removed: On November 8, 2024, the district court denied Ardelyx’s motion for a preliminary injunction and it granted the government’s
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 56
−Removed: motion to dismiss.
+Added: On November 8, 2024, the district court denied Ardelyx’s motion for a preliminary injunction and it granted the government’s motion to dismiss.
Thereafter, Ardelyx moved for reconsideration, but the district court also denied that request.
1 unchanged sentence
Court of Appeals for the DC Circuit.
−Removed: Briefing of the case has been completed and oral argument is scheduled for September 25, 2025.
+Added: Briefing of the case has
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 57
+Added: been completed and oral argument was held on September 25, 2025.
If Ardelyx is successful in its claims, oral-only phosphate lowering therapies, including Auryxia, may be removed from the ESRD bundle, which could reduce anticipated revenue for Auryxia.
4 unchanged sentences
In addition, dialysis organizations, GPOs, third party payors, PBMs and/or other entities that purchase our products may impose restrictions on our ability to raise prices for our products over time without incurring additional costs.
−Removed: Three dialysis organizations, DaVita, Fresenius Medical Care Rx and USRC, in the aggregate, accounted for a significant percentage of our gross revenue during the three months ended June 30, 2025.
+Added: Three dialysis organizations, DaVita, Fresenius Medical Care Rx and USRC, in the aggregate, accounted for a significant percentage of our gross revenue from Auryxia and Vafseo during the three and nine months ended September 30, 2025.
+Added: If we are not able to maintain supply agreements with these, and other, dialysis organizations for the sale of Vafseo and Auryxia on favorable terms, in a timely basis or at all, our business may be materially harmed.
Due to a variety of factors, including coverage of our products in the ESRD bundle and to support commercial availability of Vafseo in 2025, there were changes to the manner in which we distributed our products, which we implemented in January 2025.
1 unchanged sentence
If we are not able to enter into and maintain agreements with wholesalers, specialty distributors, the dialysis organizations and other purchasers for the sale of our products on favorable terms, on a timely basis or at all, our business may be materially harmed.
+Added: We recently also began to ship Vafseo directly to certain dialysis clinics, which requires additional oversight and logistics, and if implementation of this new distribution model is not successful, it could negatively impact our business.
In addition, if dialysis organizations or other purchasers do not purchase as much product as we anticipate or terminate our arrangements, or if due to changes in distribution, dialysis organizations and/or specialty pharmacies are not able to meet market demand causing slower dispensing times and potentially impacting refill rates, it would adversely impact the market opportunity for our products, our product revenues and operating results.
−Removed: Furthermore, the U.S.
−Removed: dialysis market is unique and is dominated by three providers:
−Removed: DaVita, Fresenius Medical Care Rx and USRC, which account for a vast majority of the dialysis population in the U.S.
−Removed: If we are not able to maintain supply agreements with these, and other, dialysis organizations for the sale of Vafseo and Auryxia on favorable terms, in a timely basis or at all, our business may be materially harmed.
Similar to how payor coverage may affect the sales of a product, formulary status within dialysis organizations may affect what products are prescribed within that specific organization.
14 unchanged sentences
Our partners may not be able to obtain such reimbursement approvals on a timely basis, if at all, and favorable pricing in certain countries depends on a number of factors, some of which are outside of our partners' control.
−Removed: Vafseo was approved in
+Added: Vafseo was approved in Japan for the treatment of adult patients with anemia due to CKD and is being marketed by MTPC in Japan under the trade name Vafseo.
+Added: Pricing and reimbursement strategy is a key component of MTPC’s commercialization plans for Vafseo in Japan.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 58
−Removed: Japan for the treatment of adult patients with anemia due to CKD and is being marketed by MTPC in Japan under the trade name Vafseo.
−Removed: Pricing and reimbursement strategy is a key component of MTPC’s commercialization plans for Vafseo in Japan.
If coverage and reimbursement terms change, MTPC may not be able to, or may decide not to, continue commercialization of Vafseo in Japan.
38 unchanged sentences
Other companies have product candidates in various stages of preclinical or clinical development to treat diseases and complications of the diseases for which we are marketing Auryxia.
−Removed: Drugs that may compete with Vafseo include Epogen® (epoetin alfa) and Aranesp® (darbepoetin alfa), both commercialized by Amgen, Procrit® (epoetin alfa) and Eprex® (epoetin alfa), commercialized by Johnson & Johnson in the U.S.
+Added: Drugs that may compete with Vafseo include Epogen® (epoetin alfa) and Aranesp® (darbepoetin alfa), both commercialized by Amgen in the U.S.
+Added: and Europe, Procrit® (epoetin alfa) and Eprex® (epoetin alfa), commercialized by Johnson & Johnson in the U.S.
and Europe, respectively, Mircera® (methoxy PEG-epoetin beta), commercialized by CSL Vifor in the U.S.
69 unchanged sentences
Failure can occur at any time during the process.
−Removed: We may be unable to successfully complete clinical trials of Auryxia, Vafseo and our product candidates or to successfully obtain approval of label expansion for Vafseo or approval of our product candidates, if the results of those trials and studies are not positive or are only modestly positive, or if there are concerns with the product profile due to efficacy or safety.
+Added: We may be unable to successfully complete clinical trials of Auryxia, Vafseo and our product candidates or to successfully obtain approval of any potential label expansion for Vafseo or approval of our product candidates, if the results of those trials and studies are not positive or are only modestly positive, or if there are concerns with the product profile due to efficacy or safety.
Further, the results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials, interim results of a clinical trial do not necessarily predict final results, and results of Phase 3 clinical trials for one indication may not be predictive of results of Phase 3 clinical trials for another indication.
7 unchanged sentences
However, we expended significant additional resources to obtain the approval of Vafseo, the approved indication is limited to the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months and the commercialization of Vafseo was delayed, which had and could continue to have an adverse effect on our business.
−Removed: We have several lifecycle management and label expansion opportunities currently under evaluation for Vafseo, one of which is the potential for alternative dosing, and another of which is label expansion for the treatment of adult patients with NDD-CKD.
−Removed: However, we will be required to complete additional clinical trials before seeking approval for label expansion for the treatment of adult patients with NDD-CKD and we may be required to generate additional clinical data before seeking approval for alternative dosing.
+Added: We have had several lifecycle management and label expansion opportunities under evaluation for Vafseo, one of which is the potential for alternative dosing, and another of which had been label expansion for the treatment of adult patients with NDD-CKD.
+Added: After a recent Type C meeting with the FDA, we determined that, while we have not yet received final minutes from the meeting, based on the FDA feedback, we have not come to alignment on a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage CKD not on dialysis.
+Added: As a result, we do not plan to initiate the VALOR clinical trial, and therefore do not expect to pursue a broad label for Vafseo for adult patients with NDD-CKD.
+Added: Based on the Type C meeting, we expect to continue to maintain a dialogue with the FDA around a potential smaller subgroup of CKD non-dialysis dependent patients where there may be potential to align on a clinical design and path forward.
+Added: However, we will be required to complete additional clinical trials before seeking approval for label expansion for a potential smaller subgroup of CKD non-dialysis dependent patients, and we may be required to generate additional clinical data before seeking approval for alternative dosing.
Clinical trials are time consuming and expensive, and even though Vafseo is approved for adult patients with anemia due to CKD on dialysis for at least three months, we may not be successful in any of our lifecycle management or label expansion opportunities in the timeframe anticipated by us, or at all.
−Removed: For example, we continue to work towards our goal to initiate VALOR, a Phase 3 cardiovascular outcome study of approximately 1,500 U.S.
−Removed: subjects with late-stage CKD anemia not on dialysis with a comparator to ESA, by the end of 2025 and recently requested a Type-C meeting with the FDA.
−Removed: However, the FDA may not agree with our study design or we may not successfully demonstrate safety and/or efficacy needed to obtain regulatory approval or we may be unable to start the trial when anticipated or successfully complete the trial when anticipated, or at all.
−Removed: If the clinical trials for our label expansion opportunities are not successful or take longer than anticipated, or if we do not obtain FDA approval of label expansion for Vafseo for the treatment of adult patients with NDD-CKD or for alternative dosing in a timely manner, or at all, it could impact future revenue and have an adverse effect on our business.
+Added: In addition, the FDA may not agree with our study design or we may not successfully demonstrate safety and/or efficacy needed to obtain regulatory approval or we may be unable to start a trial when anticipated or successfully complete a trial when anticipated, or at all.
+Added: If the clinical trials for our label expansion opportunities are not successful or take longer than anticipated, or if we do not obtain FDA approval of label expansion for alternative dosing or for a potential smaller subgroup of CKD non-dialysis dependent patients in a timely manner, or at all, it could impact future revenue and have an adverse effect on our business.
In addition, it is impossible to predict when or if any of our other product candidates will prove effective or safe in humans or will receive marketing approval or on what terms.
1 unchanged sentence
We may be required to complete additional clinical trials for Auryxia, Vafseo and any other product or product candidate, including those that may be in-licensed or acquired, in order to obtain or maintain required regulatory approvals.
−Removed: Our preclinical studies and clinical trials may take longer to complete than currently anticipated, or may be delayed, suspended, required to be repeated, prematurely terminated or may not successfully demonstrate safety and/or efficacy needed to obtain or maintain regulatory approval for a variety of other reasons, such as:
−Removed: • the costs may be greater than we anticipate;
+Added: Our preclinical studies and clinical trials may take longer to complete than currently anticipated, or may be delayed,
Akebia Therapeutics, Inc.
| Form 10-Q | Page 62
+Added: suspended, required to be repeated, prematurely terminated or may not successfully demonstrate safety and/or efficacy needed to obtain or maintain regulatory approval for a variety of other reasons, such as:
+Added: • the costs may be greater than we anticipate;
• the number of patients required for clinical trials may be larger than we anticipate;
8 unchanged sentences
• clinical trial sites and investigators deviating from the clinical protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial, or failure by us or our CROs to communicate effectively or provide the appropriate level of oversight of such clinical sites and investigators;
−Removed: • there may be an inability, delay, or failure in identifying and maintaining a sufficient number of clinical trial sites, many of which may already be engaged in other clinical programs;
+Added: • there may be an inability, delay, or failure in identifying, initiating, and maintaining a sufficient number of clinical trial sites, many of which may already be engaged in other clinical programs;
• there may be a delay or failure in reaching agreement with the FDA, the EMA, the PMDA or other regulatory authorities on a clinical trial design upon which we are able to execute;
7 unchanged sentences
• re gulators may require that we conduct additional clinical trials, repeat clinical trials or conduct other studies beyond those that we currently contemplate;
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 63
• we may be delayed in obtaining marketing approval for our product candidates;
1 unchanged sentence
• we may obtain approval for indications or patient populations that are not as broad as intended or desired;
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 62
• we may obtain approval with labeling that includes significant use or distribution restrictions or safety warnings that would reduce the potential market for any approved product or inhibit our ability to successfully commercialize any approved product;
13 unchanged sentences
For example, we began enrolling sites in a post-approval pediatric study for the control of serum phosphorus levels in adult patients with DD-CKD, or the Hyperphosphatemia Indication , of Auryxia in the second quarter of 2022, which began patient recruitment in the third quarter of 2022, but enrollment of eligible pediatric patients in study sites continues to be very slow despite efforts to do so.
+Added: We informed the FDA of the enrollment and retention challenges in the trial, and in late August 2025, the FDA recommended that we halt further enrollment in the trial until we have further discussions with the FDA.
+Added: As a result, we have halted enrollment and plan to request a meeting with the FDA.
Finally, competition for clinical trial sites may limit our access to patients appropriate for our clinical trials.
13 unchanged sentences
• site staffing shortages and turnover;
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 64
• clinical trial sites and investigators failing to perform effectively;
1 unchanged sentence
We may not be able to initiate or complete clinical trials in a timely manner, or at all, if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by regulatory agencies.
−Removed: If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 63
−Removed: clinical trials, any of which may delay approval, or result in failure to maintain or obtain approval, of our products or product candidates, which would have a material adverse effect on our business.
+Added: If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which may delay approval, or result in failure to maintain or obtain approval, of our products or product candidates, which would have a material adverse effect on our business.
Further, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may be impacted.
−Removed: For example, in December 2022, with the passage of Food and Drug Omnibus Reform Act, or FDORA , Congress required sponsors to develop and submit a diversity action plan, or DAP , for each phase 3 clinical trial or any other “pivotal study” of a new drug or biological product.
+Added: For example, in December 2022, with the passage of the Food and Drug Omnibus Reform Act, or FDORA , Congress required sponsors to develop and submit a diversity action plan, or DAP , for each phase 3 clinical trial or any other “pivotal study” of a new drug or biological product.
These plans are meant to encourage the enrollment of more diverse patient populations in late-stage clinical trials of FDA-regulated products.
26 unchanged sentences
There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction.
−Removed: If the FDA or any comparable foreign regulatory authority does not accept such data, it could result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
−Removed: Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with:
−Removed: ⦁ additional foreign regulatory requirements;
+Added: If the FDA or any comparable foreign regulatory authority does not
Akebia Therapeutics, Inc.
| Form 10-Q | Page 65
+Added: accept such data, it could result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.
+Added: Conducting clinical trials outside the United States also exposes us to additional risks, including risks associated with:
+Added: ⦁ additional foreign regulatory requirements;
⦁ foreign exchange fluctuations;
16 unchanged sentences
• REMS or FDA-imposed risk management plans that use restrictive risk minimization strategies may be required;
−Removed: • patients’ non-adherence to the prescribed treatment regimen;
+Added: • patients’ non-adherence to the prescribed tr eatment regimen;
• we may decide to, or be required to, send drug warnings or safety alerts to physicians, pharmacists and hospitals (or the FDA or other regulatory authorities may choose to issue such alerts), or we may decide to conduct a product recall or be requested to do so by the FDA or other regulatory authority;
3 unchanged sentences
• our reputation may suffer.
−Removed: Any of these events could prevent us from achieving or maintaining, whether on a restricted basis or at all, marketing approval and, ultimately, market acceptance or penetration of Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired.
−Removed: In addition, any of these events could substantially increase our costs, and could significantly impact our ability to successfully commercialize Auryxia, Vafseo or any other product and product candidate, including those that may be in-licensed or acquired, and generate product revenue.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 66
+Added: Any of these events could prevent us from achieving or maintaining, whether on a restricted basis or at all, marketing approval and, ultimately, market acceptance or penetration of Auryxia, Vafseo or any other product or product candidate, including those that may be in-licensed or acquired.
+Added: In addition, any of these events could substantially increase our costs, and could significantly impact our ability to successfully commercialize Auryxia, Vafseo or any other product and product candidate, including those that may be in-licensed or acquired, and generate product revenue.
The patient populations treated with Auryxia and Vafseo have CKD, a serious disease that increases the risk of cardiovascular disease including heart attacks and stroke and, in its most severe form, results in, kidney failure and the need for dialysis or kidney transplant.
18 unchanged sentences
Additionally, the FDA expressed safety concerns related to the risk of drug-induced liver injury in the CRL that it issued in March 2022, and these safety concerns were addressed following the FDRR and resubmission to our NDA.
−Removed: Serious adverse events related to Vafseo, including those noted in the CRL and label, and any other product candidates could have material adverse consequences on the development and potential label expansion of Vafseo or the approval of our other product candidates and our business as a whole.
+Added: Serious adverse events related to Vafseo, including those noted in the CRL and label, and any other product candidates could have material adverse consequences on the development and any potential label expansion of Vafseo or the approval of our other product candidates and our business as a whole.
Our understanding of adverse events in prior clinical trials of Vafseo or our product candidates may change as we gather more information, the FDA may not agree with our assessment of adverse events and additional unexpected adverse events may be observed in future clinical trials or in the market.
1 unchanged sentence
In addition, any post-marketing clinical trials conducted, if successful, may expand the patient populations treated with Auryxia, Vafseo or any other product we acquire or for which we receive marketing approval, within or outside of their current indications or patient populations, which could result in the identification of previously unknown undesirable effects, increased frequency or severity of known undesirable effects, or result in the identification of unexpected safety signals.
−Removed: In addition, Vafseo and any other products are commercialized, they will be used in significantly larger patient populations, in less rigorously controlled environments and, in some cases, by less experienced and less expert treating practitioners, than in clinical trials, which could result in increased or more serious adverse effects being reported.
−Removed: As a result, regulatory authorities, healthcare practitioners, third party payors or patients may perceive or conclude that the use of Auryxia, Vafseo or any other products are associated with serious adverse effects, undermining our commercialization efforts.
−Removed: Risks Related to Regulatory Approval
+Added: In addition, Vafseo and any other products are commercialized, they will be used in significantly larger patient populations, in
Akebia Therapeutics, Inc.
| Form 10-Q | Page 67
−Removed: We may not be able to obtain marketing approval for any label expansion for Vafseo or any current or future product candidate, or we may experience significant delays in doing so, any of which would materially harm our business.
+Added: less rigorously controlled environments and, in some cases, by less experienced and less expert treating practitioners, than in clinical trials, which could result in increased or more serious adverse effects being reported.
+Added: As a result, regulatory authorities, healthcare practitioners, third party payors or patients may perceive or conclude that the use of Auryxia, Vafseo or any other products are associated with serious adverse effects, undermining our commercialization efforts.
+Added: Risks Related to Regulatory Approval
+Added: We may not be able to obtain marketing approval for any potential label expansion for Vafseo or any current or future product candidate, or we may experience significant delays in doing so, any of which would materially harm our business.
Clinical trials, manufacturing and marketing of any product or product candidate are subject to extensive and rigorous review and regulation by numerous governmental authorities in the U.S.
4 unchanged sentences
and in other jurisdictions, only a small percentage successfully complete the FDA’s and other regulatory jurisdictions’ marketing approval processes and are commercialized.
−Removed: Accordingly, even if we are able to obtain the requisite capital to continue to fund our development efforts, we may be unable to successfully obtain regulatory approval for any label expansion for Vafseo or for any product candidate, including those that may be in-licensed or acquired.
+Added: Accordingly, even if we are able to obtain the requisite capital to continue to fund our development efforts, we may be unable to successfully obtain regulatory approval for any potential label expansion for Vafseo or for any product candidate, including those that may be in-licensed or acquired.
Further, any product candidate may not receive marketing approval in the U.S.
10 unchanged sentences
As a condition to receiving marketing approval for Vafseo in additional territories or for other indications, we may be required by regulatory authorities to conduct additional preclinical studies or clinical trials.
−Removed: For example, we have several lifecycle management and label expansion opportunities currently under evaluation for Vafseo, one of which is the potential for alternative dosing, and another of which is label expansion for the treatment of adult patients with NDD-CKD.
+Added: For example, we have had several lifecycle management and label expansion opportunities under evaluation for Vafseo, one of which is the potential for alternative dosing, and another of which had been label expansion for the treatment of adult patients with NDD-CKD.
However, we may be required to complete additional clinical trials before seeking approval for additional indications, which are time consuming and expensive, and even though Vafseo is approved as a treatment for anemia due to CKD for dialysis dependent patients, we may not be successful in any of our lifecycle management or label expansion opportunities in the timeframe anticipated by us, or at all.
4 unchanged sentences
patients with CKD.
−Removed: We continue to work towards our goal to initiate VALOR, a Phase 3 cardiovascular outcome study of approximately 1,500 U.S.
−Removed: subjects with late-stage CKD anemia not on dialysis with a comparator to ESA, by the end of 2025 and recently requested a Type-C meeting with the FDA.
−Removed: However, we may not successfully demonstrate safety and/or efficacy needed to obtain regulatory approval or we may be unable to start the trial when anticipated or complete the trial when anticipated or at all.
−Removed: If we do not obtain the approval of label expansion for the treatment of adult patients with NDD-CKD or for alternative dosing in a timely manner, or at all, it could impact future revenue and have an adverse effect on our business.
+Added: In addition, after a recent Type C meeting with the FDA, while we have not yet received final minutes from the meeting, based on the FDA feedback, we have not come to alignment on a path forward for the design of the VALOR clinical trial for the use of vadadustat to treat anemia in patients with late-stage CKD not on dialysis.
+Added: As a result, we do not plan to initiate the VALOR clinical trial, and therefore do not expect to pursue a broad label for Vafseo for adult patients with NDD-CKD.
+Added: Based on the Type C meeting, we expect to continue to maintain a dialogue with the FDA around a potential smaller subgroup of CKD non-dialysis patients where there may be potential to align on a clinical design and path forward.
+Added: However, the FDA may not agree with our study design or we may not successfully demonstrate safety and/or efficacy needed to obtain regulatory approval or we may be unable to start a trial when anticipated or complete a trial when anticipated or at all.
+Added: If we do not obtain the approval of label expansion for alternative dosing or for a potential smaller subgroup of CKD non-dialysis patients in a timely manner, or at all, it could impact future revenue and have an adverse effect on our business.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 68
Obtaining marketing approval in the U.S.
5 unchanged sentences
In April 2024, our partner Averoa submitted its marketing authorization application for ferric citrate in Europe.
−Removed: In March 2025, the Committee for Medicinal
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 67
−Removed: Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the European Commission, or EC , to approve Averoa’s marketing authorization.
−Removed: The EC granted marketing authorization in June 2025.
+Added: In March 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the European Commission, or EC , to approve Averoa’s marketing authorization, and the EC granted marketing authorization in June 2025.
+Added: In November 2025, the Medicines and Healthcare Products Regulatory Agency, or MHRA , granted Averoa's UK marketing authorization.
+Added: However, Averoa has not yet obtained pricing authorization nor commenced sales of ferric citrate in Europe or UK.
Safety concerns with a given product may impact marketing approval.
9 unchanged sentences
• the relevant regulatory authority may disagree with the number, design, size, conduct or implementation of our clinical trials;
−Removed: • the relevant regulatory authority may not approve the label expansion we request for Vafseo;
+Added: • the relevant regulatory authority may not approve any potential label expansion we request for Vafseo;
• the relevant regulatory authority may approve any product candidate for use only in a small patient population or for fewer or more limited indications than we request;
6 unchanged sentences
• the relevant regulatory authority could deem that our financial relationships with certain pr incipal investigators constitute a conflict of interest, such that the data from those principal investigators may not be used to support our applications;
−Removed: • as part of any future regulatory process, the FDA may ask an Advisory Committee to review portions of the NDA, the FDA may have difficulty scheduling an Advisory Committee meeting in a timely manner or, if convened, an FDA Advisory Committee could recommend non-approval, conditions of approval or restrictions on approval, and the FDA may ultimately agree with the recommendations;
+Added: • a s part of any future regulatory process, the FDA may ask an Advisory Committee to review portions of the NDA, the FDA may have difficulty scheduling an Advisory Committee meeting in a timely manner or, if convened, an FDA Advisory Committee could recommend non-approval, conditions of approval or restrictions on approval, and the FDA may ultimately agree with the recommendations;
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 69
• the relevant regulatory authority’s review process and decision-making regarding any product candidate may be impacted by the results of our and our competitors’ clinical trials and safety concerns of marketed products used to treat the same indications as the indications for which Vafseo and any other product candidate are being developed;
4 unchanged sentences
The FDA or a comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study.
−Removed: The FDA or comparable foreign regulatory authority may therefore question
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 68
−Removed: the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized.
+Added: The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized.
This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.
20 unchanged sentences
On January 16, 2025, the district court agreed to allow these states to file an amended complaint and continue to pursue this challenge.
+Added: Thereafter, on September 30, 2025, the district court declined to dismiss the case and, instead, transferred it to the federal district court in the Eastern District of Missouri.
Depending on the outcome of this litigation, our ability to develop new drug product candidates and to maintain approval of existing drug products could be delayed, undermined or subject to protracted litigation.
6 unchanged sentences
The regulatory approval process outside the United States generally includes all of the risks associated with obtaining or maintaining FDA approval.
−Removed: In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country.
+Added: In addition, in many countries outside the United States, it is required that the product be
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 70
+Added: approved for reimbursement before the product can be approved for sale in that country.
We and our partners may not obtain or maintain approvals from regulatory authorities outside the United States on a timely basis or at all.
1 unchanged sentence
The UK is no longer part of the European Single Market and EU Customs Union.
−Removed: As of January 1, 2025, the Medicines and Healthcare Products Regulatory Agency, or MHRA , is responsible for approving all medicinal products destined for the United Kingdom market (i.e., Great Britain and Northern Ireland).
+Added: As of January 1, 2025, the MHRA is responsible for approving all medicinal products destined for the United Kingdom market (i.e., Great Britain and Northern Ireland).
On April 28, 2025, the UK Parliament adopted amendments to improve and strengthen the UK’s clinical trials regulatory regime;
1 unchanged sentence
These changes were needed since the current UK requirements are based upon the now-repealed EU Clinical Trials Directive (2001/20/EC), which has been replaced by the European Clinical Trials Regulation (Regulation EU No 536/2014).
−Removed: Since the UK left the EU prior to the date on which the EU CTR took effect, the UK legal framework did not benefit from the same revisions as occurred at EU level.
+Added: In anticipation of these new requirements, on October 1, 2025, the MHRA updated its guidance for clinical trials to address, among other things, research transparency requirements for clinical trials, the approvals process, Research Ethics Committee review of clinical trials, simplified arrangements for consent in clinical trials and pharmacovigilance.
+Added: Since the UK left the EU prior to the date on which the European Trials Regulation took effect, the UK legal framework did not benefit from the same revisions as occurred at EU level.
At the same time, a new international recognition procedure, or IRP , will apply, which intends to facilitate approval of pharmaceutical products in the UK.
−Removed: The IRP is open to applicants that have already received an authorization for the same
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 69
−Removed: product from one of the MHRA’s specified Reference Regulators, or RRs.
+Added: The IRP is open to applicants that have already received an authorization for the same product from one of the MHRA’s specified Reference Regulators, or RRs.
The RRs notably include EMA and regulators in the EEA member states for approvals in the EU centralized procedure and mutual recognition procedure as well as the FDA (for product approvals granted in the U.S.).
9 unchanged sentences
This proposal will now be the subject of additional negotiations and technical meetings, with the objective of reaching agreement on issues such as the regulatory data protection framework and the access and supply obligations.
+Added: At this point, it appears that the period of market exclusivity for innovator products may be reduced from two years to one, exclusions from patent infringement for studies and trials will likely expand, and there will be a new obligation to ensure sufficient supply of medicines.
Products approved for marketing are subject to extensive post-marketing regulatory requirements, including post-approval pediatric studies for Auryxia and Vafseo, and could be subject to post-marketing restrictions or withdrawal from the market, and we may be subject to penalties, including withdrawal of marketing approval, if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, or product candidates, when and if approved.
6 unchanged sentences
Consequently, we received a notification of noncompliance with PREA.
−Removed: We have since been released from the original post marketing requirement, or PMR , and a new PMR was issued that provided that the final report was due in April 2024.
+Added: We have since been released from the original
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 71
+Added: post marketing requirement, or PMR , and a new PMR was issued that provided that the final report was due in April 2024.
In June 2023 we requested an extension of time for the submission of the final report and such request was denied by the FDA in August 2023.
−Removed: The PMR trial is ongoing and actively recruiting patients, but the final report for the trial was due in April 2024, so the trial is considered delayed.
−Removed: If we are unable to complete the study with respect to the Hyperphosphatemia Indication successfully or have further delays in completing the study, we will need to inform the FDA, have further discussions and, if the FDA finds that we failed to comply with the pediatric study requirement with regard to the Hyperphosphatemia Indication, in violation of applicable law, it could institute enforcement proceedings to seize or enjoin the sale of Auryxia, seek civil penalties or other adverse consequences, which would have a material adverse impact on our ability to commercialize Auryxia and our ability to generate revenues from Auryxia.
+Added: The PMR trial had been actively recruiting patients, but the final report for the trial was due in April 2024, so the trial is considered delayed.
+Added: We informed the FDA of the enrollment and retention challenges in the trial, and in late August 2025, the FDA recommended that we halt further enrollment in the trial until we have further discussions with the FDA.
+Added: As a result, we have halted enrollment and plan to request a meeting with the FDA.
+Added: If the FDA finds that we failed to comply with the pediatric study requirement with regard to the Hyperphosphatemia Indication, in violation of applicable law, it could institute enforcement proceedings to seize or enjoin the sale of Auryxia, seek civil penalties or other adverse consequences, which would have a material adverse impact on our ability to commercialize Auryxia and our ability to generate revenues from Auryxia.
In addition, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for Auryxia, Vafseo and any other product for which we receive regulatory approval will be subject to extensive and ongoing regulatory requirements and guidance.
These requirements and guidance include manufacturing processes and procedures (including record keeping), the implementation and operation of quality systems to control and assure the quality of the product, submissions of safety and other post-marketing information and reports, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.
−Removed: If we, our contract manufacturing organizations, or CMOs, or other third parties we engage fail to adhere to such regulatory requirements and guidance, we could suffer significant consequences, including product seizures or recalls, loss of product approval, fines and sanctions, reputational damage, loss of customer confidence, shipment delays, inventory shortages, inventory write-offs and
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 70
−Removed: other product-related charges and increased manufacturing costs, and our development or commercialization efforts may be materially harmed.
+Added: If we, our contract manufacturing organizations, or CMOs, or other third parties we engage fail to adhere to such regulatory requirements and guidance, we could suffer significant consequences, including product seizures or recalls, loss of product approval, fines and sanctions, reputational damage, loss of customer confidence, shipment delays, inventory shortages, inventory write-offs and other product-related charges and increased manufacturing costs, and our development or commercialization efforts may be materially harmed.
Post-approval discovery of previously unknown problems with an approved product, including adverse events of unanticipated severity or frequency or relating to manufacturing operations or processes, or failure to comply with regulatory requirements, may result in, among other things:
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These and any other recalls or any supply, quality or manufacturing issues in the future related to Auryxia or Vafseo could result in significant negative consequences, including reputational harm, loss of customer confidence, and a negative impact on our financials, any of which could have a material adverse effect on our business and results of operations, and may impact our ability to supply Auryxia in the U.S.
−Removed: and Vafseo in the U.S., Japan, Europe or in other countries, for commercial and clinical use.
+Added: or Europe and Vafseo in the U.S., Japan, Europe or in other countries, for commercial and clinical use.
Non-compliance with the FDA, the EMA, the PMDA and other regulatory authorities’ requirements regarding safety monitoring or pharmacovigilance can also result in significant financial penalties.
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Risks Related to Governmental Regulation and Compliance
−Removed: We are subject to complex regulatory schemes that require significant resources to ensure compliance and our failure to comply with applicable laws could subject us to government scrutiny or enforcement, potentially resulting in costly investigations, fines, penalties or sanctions, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
+Added: We are subject to complex regulatory schemes that require significant resources to ensure compliance and our failure to comply with applicable laws could subject us to government scrutiny or enforcement, potentially resulting in costly
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 72
+Added: investigations, fines, penalties or sanctions, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
In general, a variety of laws apply to us or may otherwise restrict our activities, including the following:
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• environmental, health and safety laws and regulations;
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 71
• international trade laws, which are laws that regulate the sale, purchase, import, export, re-export, transfer and shipment of goods, products, materials, services and technology.
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• the federal Open Payments Act (the former Physician Payments Sunshine Act) requires applicable manufacturers of covered drugs to report payments and other transfers of value to physicians, other healthcare providers and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 73
• analogous state laws and regulations, such as state anti-kickback and false claims laws and gift ban and transparency statutes, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by state Medicaid or other programs, or non-governmental third party payors, including private insurers, and which are not preempted by federal laws and often differ from state to state, thus complicating compliance efforts;
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State and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 72
Efforts to ensure that our business complies with applicable healthcare laws and regulations involve substantial costs and require us to expend significant resources.
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Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government funded healthcare programs.
−Removed: We will incur significant liability if it is determined that we are promoting any “off-label” use of Auryxia, Vafseo or any other product we may develop, in-license or acquire or if it is determined that any of our activities violates the federal Anti-Kickback Statute.
+Added: We will incur significant liability if it is determined that we are promoting any “off-label” use of Auryxia, Vafseo or any other product we may develop, in-license or acquire or we are found to have improperly promoted such products through direct-to-consumer advertising, or if it is determined that any of our activities violates the federal Anti-Kickback Statute.
Physicians are permitted to prescribe drug products for uses that differ from those approved by the FDA or other applicable regulatory agencies.
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In September 2021, the FDA published final regulations which describe the types of evidence that the agency will consider in determining the intended use of a drug product.
−Removed: In addition, laws and regulations govern the distribution and tracing of prescription drugs and prescription drug samples, including the Prescription Drug Marketing Act of 1976 and the Drug Supply Chain Security Act, which regulate the distribution and tracing of prescription drugs and prescription drug samples at the federal level and set minimum standards for the regulation of drug distributors by the states.
+Added: In addition, laws and regulations govern the distribution and tracing of
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 74
+Added: prescription drugs and prescription drug samples, including the Prescription Drug Marketing Act of 1976 and the Drug Supply Chain Security Act, which regulate the distribution and tracing of prescription drugs and prescription drug samples at the federal level and set minimum standards for the regulation of drug distributors by the states.
A company that is found to have improperly promoted off-label uses or to have otherwise engaged in false or misleading promotion or improper distribution of drugs will be subject to significant liability, potentially including civil and administrative remedies as well as criminal sanctions.
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We intend to engage in these discussions and communicate with healthcare providers, payors and other constituencies in compliance with all applicable laws, regulatory guidance and industry best practices.
−Removed: Although we believe we have put in place a robust compliance program and processes designed to ensure that all such activities are performed in a legal and compliant manner, such program and processes may
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 73
−Removed: not be sufficient to deter or detect all violations, and we will need to carefully navigate the FDA’s various regulations, guidance and policies, along with recently enacted legislation, to ensure compliance with restrictions governing promotion of our products.
+Added: Although we believe we have put in place a robust compliance program and processes designed to ensure that all such activities are performed in a legal and compliant manner, such program and processes may not be sufficient to deter or detect all violations, and we will need to carefully navigate the FDA’s various regulations, guidance and policies, along with recently enacted legislation, to ensure compliance with restrictions governing promotion of our products.
+Added: Further, we will need to ensure full compliance with the administration’s recently announced enforcement position on direct-to-consumer, or DTC , prescription drug advertising and related promotional activities.
+Added: On September 9, 2025, the President issued a Memorandum directing HHS to ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements.
+Added: The same day, the Make America Healthy Again Commission released a report declaring that the FDA, HHS, FTC and DOJ will increase oversight and enforcement under current authorities for violations of direct-to-consumer, or DTC , prescription drug advertising laws.
+Added: To that end, the FDA announced that it is initiating a rulemaking process to eliminate the adequate provision loophole that allows pharmaceutical advertisements to hide safety information by placing it in another format or location.
+Added: In this context, the FDA declared that it will no longer tolerate what it characterized as deceptive practices in prescription drug advertising and that the agency would aggressively deploy its available enforcement tools, with heightened scrutiny of fair balance and disclosures in social media promotions.
+Added: The FDA also issued a generic notice letter to a substantial number of companies, including Akebia, directing such companies to remove any noncompliant advertising and bring all promotional communications into compliance.
+Added: We believe that we maintain a robust compliance program and processes designed to ensure that all promotional advertising activities are performed in a legal and compliant manner.
+Added: However, given the administration’s enforcement position on these issues, we may be at increased risk that the FDA, DOJ or FTC will find our promotional advertising and other digital campaigns, including social media activities, are not in compliance with fair balance requirements and anticipated rule changes at the FDA and possibly other agencies.
In addition, if a company’s activities are determined to have violated the federal Anti-Kickback Statute, this will also give rise to liability under the federal False Claims Act and such violations can result in significant fines, criminal and civil remedies, and exclusion from Medicare and Medicaid.
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If any of our relationships or activities is determined to violate applicable federal and state anti-kickback laws, false claims laws, or other laws or regulations, the company and/or company executives, employees, and other representatives could be subject to significant fines and criminal sanctions, imprisonment, and potential exclusion from Medicare and Medicaid, and could harm our reputation or result in significant legal expenses and distraction of management.
−Removed: Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
+Added: Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 75
+Added: development program and develop and secure approval of our product candidates in a timely manner, which would negatively impact our business.
The FDA and comparable regulatory agencies in foreign jurisdictions, such as the EMA and The Committee for Medicinal Products, play an important role in the development of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions, including INDs, requests for special designations and marketing applications.
If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of our product candidates could be impacted in a negative manner.
−Removed: For example, the recent loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, or review and approval of our products and product candidates.
+Added: For example, the recent loss and retirement of FDA leadership and personnel and the recent government shutdown could lead to disruptions and delays in FDA guidance, or review and approval of our products and product candidates.
Pursuant to President Trump's E.O.
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government agencies such as the National Institutes of Health, National Science Foundation, Centers for Disease Control and Prevention and FDA, which have traditionally provided funding for basic research, R&D, and clinical testing.
−Removed: government actions have included,
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 74
−Removed: among other things, suspending, terminating and withholding of disbursements of funds owed under ongoing contracts, grants, and other financial assistance agreements;
+Added: government actions have included, among other things, suspending, terminating and withholding of disbursements of funds owed under ongoing contracts, grants, and other financial assistance agreements;
declining to continue multi-year research projects for additional annual budget periods;
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In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund R&D activities, is subject to the political process, which is inherently fluid and unpredictable.
−Removed: For example, over the last several years, the U.S.
+Added: For example, the U.S.
+Added: government shut down on October 1, 2025, and as of November 7, 2025 it has not reopened.
+Added: Over the last several years, the
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 76
government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.
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In addition, the GDPR provides that EU Member States may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data and permits EU Member States to adopt further penalties for violations that are not subject to the administrative fines outlined in the GDPR.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 75
The GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, including the U.S.
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have also agreed to a U.S.-UK “Data Bridge”, which functions similarly to the EU-U.S.
−Removed: Data Privacy Framework and provides an additional legal mechanism for companies to transfer data from the UK to the U.S.
+Added: Data Privacy Framework and provides an additional legal
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 77
+Added: mechanism for companies to transfer data from the UK to the U.S.
In addition to the UK, Switzerland has approved an adequacy decision in relation to the Swiss-U.S.
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For example, the CCPA, which went into effect on January 1, 2020, and the CPRA, which amends CCPA by expanding the scope and applicability, while also introducing new privacy protections, is creating similar risks and obligations as those created by GDPR.
−Removed: In November 2020, California voters passed a ballot initiative for the CPRA, which went into effect on January 1, 2023 and significantly expanded the CCPA to incorporate additional GDPR-like provisions including requiring that the use, retention and sharing of personal information of California residents be reasonably necessary and proportionate to the purposes of collection or processing, granting additional
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 76
−Removed: protections for sensitive personal information, and requiring greater disclosures related to notice to residents regarding retention of information.
+Added: In November 2020, California voters passed a ballot initiative for the CPRA, which went into effect on January 1, 2023 and significantly expanded the CCPA to incorporate additional GDPR-like provisions including requiring that the use, retention and sharing of personal information of California residents be reasonably necessary and proportionate to the purposes of collection or processing, granting additional protections for sensitive personal information, and requiring greater disclosures related to notice to residents regarding retention of information.
The CPRA also creates a new agency that is specifically responsible for enforcing the new law and other California privacy laws.
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There are also states that are specifically regulating health information that may affect our business.
−Removed: For example, the State of Washington passed the My Health My Data Act in 2023 which specifically regulated health information that is not otherwise regulated by the HIPAA rules, and the law also has a private right of action, which further increases the relevant compliance risk.
+Added: For example, the State of Washington passed the My Health My Data Act in 2023
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 78
+Added: which specifically regulated health information that is not otherwise regulated by the HIPAA rules, and the law also has a private right of action, which further increases the relevant compliance risk.
Connecticut and Nevada have also passed similar laws regulating consumer health data, and more states are considering such legislation.
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Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our reputation and our business.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 77
Further, we cannot assure you that our third-party service providers with access to our or our customers’, suppliers’, trial patients’ and employees’ personally identifiable and other sensitive or confidential information in relation to which we are responsible will not breach contractual obligations imposed by us, or that they will not experience data security breaches or attempts thereof, which could have a corresponding effect on our business, including putting us in breach of our obligations under privacy laws and regulations and/or which could in turn adversely affect our business, results of operations and financial condition.
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The pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by legislative initiatives.
−Removed: Current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and additional downward pressure on the price that we receive for any FDA approved product, such as Auryxia or Vafseo or any reimbursement that physicians receive for administering any approved product.
+Added: Current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and additional
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 79
+Added: downward pressure on the price that we receive for any FDA approved product, such as Auryxia or Vafseo or any reimbursement that physicians receive for administering any approved product.
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA , changed the way Medicare covers and pays for pharmaceutical products.
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At the federal level, Congress and the current administration have each indicated that it will continue to seek new legislative and/or administrative measures to control drug costs.
−Removed: In addition, in October 2020, the HHS and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program to import certain prescription drugs from Canada into the U.S.
+Added: In addition, in October 2020, the HHS and the FDA published a final rule allowing states and other entities to develop a Section 804 Importation Program, or SIP , to import certain prescription drugs from Canada into the U.S.
That regulation was challenged in a lawsuit by the Pharmaceutical Research and Manufacturers of America, or PhRMA , but the case was dismissed by a federal district court in February 2023 after the court found that PhRMA did not have standing to sue HHS.
−Removed: Seven states (Colorado, Florida, Maine, New Hampshire, New Mexico, Texas and Vermont) have passed laws allowing for the importation
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 78
−Removed: of drugs from Canada.
+Added: Seven states (Colorado, Florida, Maine, New Hampshire, New Mexico, Texas and Vermont) have passed laws allowing for the importation of drugs from Canada.
North Dakota and Virginia have passed legislation establishing workgroups to examine the impact of a state importation program.
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On January 5, 2024, the FDA approved Florida’s plan for Canadian drug importation.
−Removed: Florida now has authority to import certain drugs from Canada for a period of two years once certain conditions are met.
+Added: On December 20, 2024 and June 2, 2025, the FDA granted 6-month and 4-month extensions to Florida’s existing SIP authorizations based on Florida’s commitment to move forward with the next steps for launching its SIP.
+Added: Florida has authority to import certain drugs from Canada for a period of two years once certain conditions are met.
Florida will first need to submit a pre-import request for each drug selected for importation, which must be approved by the FDA.
The state will also need to relabel the drugs and perform quality testing of the products to meet FDA standards.
−Removed: On May 21, 2025, the FDA announced that it would offer individual states the opportunity to submit a draft proposal for pre-review and meet with the agency to obtain initial feedback from FDA prior to formally submitting their section 804 importation program (SIP) proposal.
+Added: On May 21, 2025, the FDA announced that it would offer individual states the opportunity to submit a draft proposal for pre-review and meet with the agency to obtain initial feedback from FDA prior to formally submitting their SIP proposal.
The intent of these meetings is to assist states in developing their proposals by further clarifying requirements, enhancing the quality of proposals submitted to the agency and ultimately shortening the review timeline.
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In January 2011, CMS implemented the ESRD PPS, a prospective payment system for dialysis treatment.
−Removed: Under the ESRD PPS, CMS generally makes a single bundled payment to the dialysis facility for each dialysis treatment that covers all items and services routinely required for dialysis treatments furnished to Medicare beneficiaries in Medicare-certified ESRD facilities or at their home.
+Added: Under the ESRD PPS, CMS generally makes a single bundled
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 80
+Added: payment to the dialysis facility for each dialysis treatment that covers all items and services routinely required for dialysis treatments furnished to Medicare beneficiaries in Medicare-certified ESRD facilities or at their home.
As of January 2025, oral-only ESRD-related drugs without injectable or intravenous equivalents, including Auryxia and other phosphate lowering medications, are included in the ESRD bundle and separate Medicare payment for these drugs is no longer available under Medicare Part D.
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On December 26, 2024, Ardelyx filed a notice of appeal with the US Court of Appeals for the DC Circuit.
−Removed: Briefing of the case has been completed and oral argument is scheduled for September 25, 2025.
+Added: Briefing of the case has been completed and oral argument was held on September 25, 2025.
If Ardelyx is successful in its claims, oral-only phosphate lowering therapies, including Auryxia, may be removed from the ESRD bundle, which could reduce anticipated revenue for Auryxia.
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This provision applies to drug products that have been approved for at least 9 years and biologics that have been licensed for 13 years, but it does not apply to drugs and biologics that have been approved for a single rare disease or condition.
−Removed: With passage of the One Big Beautiful Bill Act on July 3, 2025, which was signed into law on July 4, 2025, Congress extended this exemption to drugs and
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 79
−Removed: biologics with multiple orphan drug designations.
+Added: With passage of the One Big Beautiful Bill Act on July 3, 2025, which was signed into law on July 4, 2025, Congress extended this exemption to drugs and biologics with multiple orphan drug designations.
On August 15, 2024, HHS published the results of the first Medicare drug price negotiations for ten selected drugs that treat a range of conditions, including diabetes, CKD and rheumatoid arthritis.
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The law also caps Medicare out-of-pocket drug costs at an estimated $2,000.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 81
On June 6, 2023, Merck & Co.
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The letters also urged these companies to stipulate that they will not offer other developed nations better prices for new drugs than the prices offered for such products in the U.S.
−Removed: The letters called for engagement with the FDA and CMS within 60 days to implement these changes and threatened to use “every tool in our arsenal” to address what the letter characterized as “abusive drug pricing practices.” The implications and consequences of these actions and subsequent actions by the Trump Administration to compel an MFN regulatory pricing requirement in the U.S.
−Removed: remain unclear and uncertain and are likely to result in litigation.
+Added: The letters called for engagement with the FDA and CMS within 60 days to implement these changes and threatened to use “every tool in our arsenal” to address what the letter characterized as “abusive drug pricing practices.”
+Added: On September 30, 2025, the administration announced that Pfizer had agreed to base its pharmaceutical prices in the U.S.
+Added: on MFN pricing.
+Added: According to a White House fact sheet, the agreement “will provide every State Medicaid program in the country access to MFN drug prices” on the company’s products, and requires the company “to offer medicines at a deep discount off the list price when selling directly to American patients.” Pfizer indicated that the agreement “provides certainty from tariffs” and that the company “will also participate in a direct purchasing platform, TrumpRx.gov, that will allow American patients to purchase medicines…at a significant discount.” Thereafter, on October 10, 2025, another pharmaceutical company, AstraZeneca, announced that it too had reached an agreement with the administration to lower prices for "eligible patients with prescriptions for chronic diseases" in the U.S.
+Added: and that it will participate in the TrumpRx direct-to-patient marketing website.
+Added: In addition, the industry is awaiting the release of the Global Benchmark for Efficient Drug Pricing, or GLOBE , Model, a proposed rule by CMS that is currently pending review at the Office of Information and Regulatory Affairs within the Office of Management and Budget.
+Added: Once released, the GLOBE Model proposed rule will provide further insight into how the administration is seeking to advance drug pricing policy and provide an opportunity for interested parties to submit public comment as part of the rulemaking process.
Akebia Therapeutics, Inc.
| Form 10-Q | Page 82
+Added: The implications and consequences of these actions and subsequent actions by the Trump Administration to compel an MFN regulatory pricing requirement in the U.S.
+Added: continue to remain unclear and uncertain and could ultimately result in litigation.
+Added: However, if an MFN regulatory pricing requirement is implemented in the U.S., it could have an adverse effect on our business.
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
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As a condition of reimbursement by various federal and state health insurance programs, we are required to calculate and report certain pricing information to federal and state agencies.
−Removed: The regulations governing the calculations, price reporting and payment obligations are complex and subject to interpretation by various government and regulatory agencies, as well as the courts.
+Added: The regulations governing the calculations, price reporting and payment obligations are complex and subject to interpretation by various government and regulatory agencies, as well as
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 83
Reasonable assumptions have been made where there is lack of regulations or clear guidance and such assumptions involve subjective decisions and estimates.
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Such revisions could affect our liability to federal and state payors and also adversely impact our reported financial results of operations in the period of such restatement.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 81
−Removed: several states have either implemented or are considering implementation of drug price transparency legislation that may prevent or limit our ability to take price increases at certain rates or frequencies.
+Added: Further, several states have either implemented or are considering implementation of drug price transparency legislation that may prevent or limit our ability to take price increases at certain rates or frequencies.
Requirements under such laws include advance notice of planned price increases, reporting price increase amounts and factors considered in taking such increases, wholesale acquisition cost information disclosure to prescribers, purchasers, and state agencies, and new product notice and reporting.
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To bring an action under the statute, the developer of a product candidate that seeks to develop the product and seek approval under an ANDA, 505(b)(2) NDA, or biosimilar product application must take certain steps to request the reference product from the reference product manufacturer, which, in the case of products covered by a REMS with elements to assure safe use, include obtaining authorization from the FDA for the acquisition of the reference product.
−Removed: If the reference product manufacturer does not provide the reference product and the ANDA, 505(b)(2) NDA, or biosimilar product sponsor does bring an action for failure to provide a reference product, there are certain affirmative defenses available to the reference product manufacturer, which must be shown by a preponderance of evidence, including that the NDA or BLA holder sells the reference product through agents, distributors, or wholesalers and has placed no restrictions, explicit or implicit, on selling the reference product to ANDA, 505(b)(2) or biosimilar sponsors.
−Removed: If the sponsor prevails in litigation, it is entitled to a court
+Added: If the reference product manufacturer does not provide the reference product and the ANDA, 505(b)(2) NDA, or biosimilar product sponsor does bring
Akebia Therapeutics, Inc.
| Form 10-Q | Page 84
−Removed: order directing the reference product manufacturer to provide, without delay, sufficient quantities of the applicable product on commercially reasonable, market-based terms, plus reasonable attorney fees and costs.
+Added: an action for failure to provide a reference product, there are certain affirmative defenses available to the reference product manufacturer, which must be shown by a preponderance of evidence, including that the NDA or BLA holder sells the reference product through agents, distributors, or wholesalers and has placed no restrictions, explicit or implicit, on selling the reference product to ANDA, 505(b)(2) or biosimilar sponsors.
+Added: If the sponsor prevails in litigation, it is entitled to a court order directing the reference product manufacturer to provide, without delay, sufficient quantities of the applicable product on commercially reasonable, market-based terms, plus reasonable attorney fees and costs.
Additionally, the new statutory provisions authorize a federal court to award the product developer an amount “sufficient to deter” the reference product manufacturer from refusing to provide sufficient product quantities on commercially reasonable, market-based terms, up to a certain maximum amount based on revenue earned while in noncompliance, if the court finds, by a preponderance of the evidence, that the reference product manufacturer did not have a legitimate business justification to delay providing the product or failed to comply with the court’s order.
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In addition, we are responsible for supplying product to our AG Partner, and if there are problems in the supply chain, we could be subject to certain penalties, which could be substantial.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 85
With respect to Vafseo, we entered into a collaboration agreement with MTPC to develop and commercialize Vafseo in Japan and certain other Asian countries.
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For example, on May 13, 2022, Otsuka Pharmaceutical Co.
−Removed: Ltd., or Otsuka , elected to terminate our collaboration agreements related to Vafseo, and we
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 83
−Removed: subsequently negotiated a Termination and Settlement Agreement with Otsuka.
+Added: Ltd., or Otsuka , elected to terminate our collaboration agreements related to Vafseo, and we subsequently negotiated a Termination and Settlement Agreement with Otsuka.
This termination by Otsuka may have delayed the launch of Vafseo in Europe or other territories previously licensed to Otsuka or adversely affected how we are perceived in scientific and financial communities.
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Collaborations may also divert resources, including the attention of management and other employees, from other parts of our business, which could have an adverse effect on other parts of our business, and we cannot be certain that the benefits of the collaboration will outweigh the potential risks.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 86
We may seek to establish additional collaborations and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
1 unchanged sentence
For example, in May 2023, we entered into the license agreement with 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 Medice Territory.
−Removed: Any of these relationships may require us to incur non-recurring and other charges, increase our near
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 84
−Removed: and long-term expenditures, issue securities that dilute our existing stockholders, divert management’s attention, or disrupt our business.
+Added: Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, divert management’s attention, or disrupt our business.
We may not be successful in entering into additional collaborations as a result of many factors, including the following:
19 unchanged sentences
Negative fluctuations in these royalty revenues could delay, diminish or eliminate our ability to receive 85% of the Royalty Interest Payments after the Annual Cap is achieved in a given calendar year, or our ability to receive 100% of the Royalty Interest Payments after the Aggregate Cap is achieved.
−Removed: We rely upon third parties to conduct all aspects of our product manufacturing and commercial distribution, and in many instances only have a single supplier or distributor, and the loss of these manufacturers or distributors, their failure to supply us on a timely basis, or at all, or their failure to successfully carry out their contractual duties or comply with regulatory requirements, cGMP requirements or guidance could cause delays in or disruptions to our supply chain and substantially harm our business.
+Added: We rely upon third parties to conduct all aspects of our product manufacturing and commercial distribution, and in many instances only have a single supplier or distributor, and the loss of these manufacturers or distributors, their failure to supply us on a timely basis, or at all, or their failure to successfully carry out their contractual duties or comply with
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 87
+Added: regulatory requirements, cGMP requirements or guidance could cause delays in or disruptions to our supply chain and substantially harm our business.
We do not have any manufacturing facilities and do not expect to independently manufacture any products or product candidates.
2 unchanged sentences
Our reliance on third-party manufacturers, who have control over the manufacturing process, increases the risk that we will not have or be able to maintain or distribute sufficient quantities of Auryxia, Vafseo or any of our product candidates or the ability to obtain such quantities at an acceptable cost or quality, which could delay, prevent or impair our and our partners' development or commercialization efforts.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 85
−Removed: We currently rely on a single source supplier for Auryxia drug substance and drug product, including for our authorized generic, and commercial supply from other suppliers may not be readily available.
+Added: We currently rely on a single source supplier for Auryxia drug substance and drug product, including for our authorized generic, and commercial supply from other suppliers is not readily available.
We have also engaged Cardinal Health, Inc., as the exclusive third-party logistics distribution agent for commercial sales of Auryxia and Vafseo.
If any of the following occurs, we may not have sufficient quantities of Auryxia, Vafseo or our product candidates to support our clinical trials, development, commercialization, or obtaining and maintaining marketing approvals, which could materially and adversely impact our business and results of operations:
−Removed: • we are unsuccessful in maintaining our current supply arrangements for commercial quantities of Auryxia and Vafseo;
+Added: • we are unsuccessful in maintaining our current supply arrangements for commercial quantities of Auryxia and Vafseo, or such arrangements are terminated;
• we are unsuccessful in validating new sites;
−Removed: • our commercial supply arrangements for Auryxia or Vafseo are terminated;
−Removed: • any of our third-party manufacturers are unable to fulfill the terms of their agreements with us due to technical issues, natural disasters or other reasons, including with respect to quality and quantity, or are unable or unwilling to continue to manufacture on the manufacturing lines included in our regulatory filings;
+Added: • we are unable to maintain adequate inventory levels;
+Added: • any of our third-party manufacturers are unable to fulfill the terms of their agreements with us or orders that we place under those agreements due to technical issues, resource constraints, natural disasters or other reasons, including with respect to quality and quantity, or are unable or unwilling to continue to manufacture sufficient quantities or at all on the manufacturing lines included in our regulatory filings;
• any of our third-party manufacturers breach our supply agreements, do not comply with quality or regulatory requirements and guidance, including cGMP or are subject to regulatory review or ceases their operations for any reason;
• any of our third-party distributors fail to perform or encounter any damage or other disruption at their facilities.
−Removed: If we, or any of our third-party manufacturers or distributors cannot or do not perform as agreed or expected, or any of our customers were to experience further shutdowns, delays or other business disruptions, including as a result of catastrophic events, including pandemics, terrorist attacks, wars or other armed conflicts, geopolitical tensions, tariffs, trade agreement disputes, or natural disasters, if they misappropriate our proprietary information, if they terminate their engagements with us, if we terminate our engagements with them, or if there is a significant disagreement, we may be forced to manufacture or distribute the materials ourselves, for which we currently do not have the capabilities or resources, or enter into agreements with other third-party manufacturers or distributors, which we may not be able to do in a timely manner or on favorable or reasonable terms, if at all.
−Removed: If any of these events occur, especially with respect to one of our sole source suppliers, we may not have sufficient quantities of product for the commercial distribution of Auryxia and/or Vafseo or may experience delays in the development of our products or product candidates, which could materially and adversely impact our business and results of operation.
−Removed: In addition, if we do not have sufficient quantities of Auryxia, including our authorized generic, or Vafseo to satisfy the requirements of our customer and supply contracts, we may be subject to contractual penalties, which could be substantial.
+Added: If we, or any of our third-party manufacturers or distributors cannot or do not perform as agreed or expected, or any of our customers were to experience further shutdowns, delays or other business disruptions, including as a result of resource constraints, catastrophic events, including pandemics, terrorist attacks, wars or other armed conflicts, geopolitical tensions, tariffs, trade agreement disputes, or natural disasters, if they misappropriate our proprietary information, if they terminate their engagements with us, if we terminate our engagements with them, or if there is a significant disagreement, we may be forced to manufacture or distribute the materials ourselves, for which we currently do not have the capabilities or resources, or enter into agreements with other third-party manufacturers or distributors, which we may not be able to do in a timely manner or on favorable or reasonable terms, if at all.
+Added: If any of these events occur, especially with respect to one of our sole source suppliers, we may not have sufficient quantities of product for the commercial distribution of Auryxia and/or Vafseo or may experience delays in the development of Vafseo or our product candidates, which could materially and adversely impact our business and results of operation.
+Added: In addition, if we do not have sufficient quantities of Auryxia, including our authorized generic, or Vafseo to satisfy the requirements of our customer and supply contracts, including inventory levels, we have incurred, and may in the future incur, contractual penalties, which could be substantial.
In some cases, there may be a limited number of qualified replacement manufacturers, or the technical skills or equipment required to manufacture a product or product candidate may be unique or proprietary to the original manufacturer, and we may have difficulty transferring such skills or technology to another third party, or a feasible alternative may not exist.
−Removed: These factors would increase our reliance on our current manufacturers or require us to obtain necessary regulatory approvals and licenses in order to have another third-party manufacture Auryxia or Vafseo.
+Added: In addition, these factors would increase our reliance on our current manufacturers or require us to obtain necessary regulatory approvals and licenses in order to have another third-party manufacture Auryxia or Vafseo.
If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines.
2 unchanged sentences
We have limited control over the production costs of Auryxia and Vafseo, including the costs of raw materials, and have seen increases in the production costs of Auryxia and Vafseo, and any significant increase in the cost of obtaining our products could materially adversely affect our revenue for Auryxia and Vafseo.
−Removed: Moreover, issues that may arise in any scale-up and technology transfer and/or continued commercial scale manufacture of our products may lead to significant delays in our development, marketing approval and commercial timelines for new products or affect commercial supply of Auryxia or Vafseo and negatively impact our financial performance.
−Removed: For example, a production-related issue resulted in an interruption in the supply of Auryxia in the third and fourth quarters of 2016.
−Removed: This supply interruption negatively impacted our revenues in 2016.
−Removed: This supply interruption was resolved, and we have taken and continue to take actions designed to prevent future interruptions in the supply of Auryxia.
−Removed: However, we have experienced issues in manufacturing Auryxia, and if we experience manufacturing issues going forward, or incur additional costs, or our actions to prevent future interruptions are not successful, we may experience additional supply issues.
−Removed: In addition, before we can manufacture product at a new site, we must validate the process at that site.
−Removed: If the process validation is unsuccessful, or takes longer than we anticipate, we may have to expend additional resources and could experience a supply interruption.
−Removed: Any future supply interruptions, whether quality or quantity based, for Auryxia or Vafseo where approved, would negatively and materially impact our reputation and financial condition.
+Added: Moreover, issues that may arise in any scale-up, technology transfer, or continued commercial scale manufacture of our products may lead to significant delays in our development, marketing approval and commercial timelines for new products
Akebia Therapeutics, Inc.
| Form 10-Q | Page 88
+Added: or affect commercial supply of Auryxia or Vafseo and negatively impact our financial performance.
+Added: For example, we have experienced issues in manufacturing Auryxia, including capacity constraints, which have impacted inventory levels, and if we experience manufacturing issues going forward, or incur additional costs, or our actions to prevent future interruptions are not successful, we may experience additional supply issues.
+Added: If we are unable to produce sufficient quantities of Auryxia drug product to satisfy the requirements of our customer and supply contracts, it could have an adverse impact on our business.
+Added: In addition, before we can manufacture product at a new site, we may need to validate the process at that site.
+Added: If the process validation is unsuccessful, or takes longer than we anticipate, we may have to expend additional resources and could experience a supply interruption.
+Added: Any future supply interruptions, whether related to inventory levels, capacity, quality or quantity, for Auryxia or Vafseo where approved may negatively and materially impact our reputation and financial condition.
There are a limited number of manufacturers that are capable of manufacturing Auryxia and Vafseo for us and complying with cGMP regulations and guidance and other stringent regulatory requirements and guidance enforced by the FDA, EMA, PMDA and other global regulatory authorities.
7 unchanged sentences
If any of these events occur, our reputation and financial condition would be negatively and materially impacted.
−Removed: In addition, if we have high amounts of write-downs to inventory reserves in the future, it could negatively impact our ability to supply Auryxia or Vafseo, and our financial condition could be harmed.
+Added: In addition, if we have high amounts of write-downs to inventory levels in the future, it could negatively impact our ability to supply Auryxia or Vafseo, and our financial condition could be harmed.
If the FDA, EMA or other regulatory authorities withdraws any approval of the facilities being used to manufacture Auryxia, Vafseo or any of our product candidates, we may need to find alternative manufacturing facilities, which would significantly impact our ability to continue commercializing Auryxia or Vafseo in Japan, or to commercialize Vafseo in Europe and other countries, or to develop, obtain marketing approval for or market Vafseo our other product candidates, if approved.
1 unchanged sentence
For example, we previously conducted three limited, voluntary recalls of Auryxia.
−Removed: These and any other recalls or any supply, quality or manufacturing issues in the future and any related write-downs of inventory or other consequences could result in significant negative consequences, including reputational harm, loss of customer confidence, and a negative impact on our financials, any of which could have a material adverse effect on our business and results of operations, and may impact our ability to supply Auryxia or Vafseo for clinical and commercial use.
+Added: Any other recalls or any supply, quality or manufacturing issues in the future and any related write-downs of inventory or other consequences could result in significant negative consequences, including reputational harm, loss of customer confidence, and a negative impact on our financials, any of which could have a material adverse effect on our business and results of operations, and may impact our ability to supply Auryxia or Vafseo for clinical and commercial use.
Also, if our starting materials, drug substance or drug product are damaged or lost while in our or our third-party manufacturers’ or distributors' control, it may adversely impact our ability to supply Auryxia or Vafseo, and we may incur significant financial harm.
3 unchanged sentences
Any of the foregoing could negatively impact our third-party manufacturers' or distributors' ability to meet our demand, which could adversely impact our ability to supply Auryxia, Vafseo or our product candidates, and we may incur significant financial harm.
−Removed: Our current and anticipated future dependence on third parties for the manufacture and distribution of Auryxia, Vafseo and our product candidates may adversely affect our and our partners' ability to commercialize Auryxia, Vafseo and our product candidates, where approved, on a timely and competitive basis and may reduce any future profit margins.
−Removed: We rely upon third parties to conduct our clinical trials and certain of our preclinical studies.
−Removed: If they do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to
Akebia Therapeutics, Inc.
| Form 10-Q | Page 89
−Removed: obtain or maintain marketing approval for Auryxia, Vafseo or any of our product candidates, and our business could be substantially harmed.
+Added: Our current and anticipated future dependence on third parties for the manufacture and distribution of Auryxia, Vafseo and our product candidates may adversely affect our and our partners' ability to commercialize Auryxia, Vafseo and our product candidates, where approved, on a timely and competitive basis and may reduce any future profit margins.
+Added: We rely upon third parties to conduct our clinical trials and certain of our preclinical studies.
+Added: If they do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain or maintain marketing approval for Auryxia, Vafseo or any of our product candidates, and our business could be substantially harmed.
We do not have the ability to independently conduct certain preclinical studies and clinical trials.
6 unchanged sentences
If the third parties upon whom we rely to conduct our trials fail to adhere to clinical trial protocols or to regulatory requirements, the quantity, quality or accuracy of the data obtained by the third parties may be compromised.
−Removed: We are exposed to risk of fraud or other misconduct by such third parties.
+Added: We are exposed to the risk of fraud or other misconduct by such third parties.
Any of these events could cause our preclinical studies and clinical trials, including post-approval clinical trials, to be extended, delayed, suspended, required to be repeated or terminated, or we may receive untitled warning letters or be the subject of an enforcement action, which could result in our failing to maintain marketing approval of Auryxia or Vafseo, or failing to obtain or maintain marketing approval for any other product candidates on a timely basis or at all, any of which would adversely affect our business operations.
14 unchanged sentences
If we do not meet our obligations in a timely manner, or if we otherwise breach the terms of the Panion License Agreement, Panion could terminate the agreement, and we would lose the rights to Auryxia.
−Removed: For example, following announcement of the Merger, Panion notified us in writing that Panion would terminate the Panion License Agreement on November 21, 2018 if we did not cure the breach alleged by Panion, specifically, that we failed to use commercially reasonable best efforts to commercialize Auryxia outside the U.S.
−Removed: We disagreed with Panion’s claims, and the parties entered discussions to resolve this dispute.
−Removed: On October 24, 2018, prior to the consummation of the Merger, we and Panion entered into a letter agreement, or the Panion Letter Agreement , pursuant to which Panion agreed to rescind any and all prior termination threats or notices relating to the Panion License Agreement and waived its rights to terminate the license agreement based on any breach by us
+Added: For example, following announcement of the Merger, Panion notified us in writing that Panion would terminate the Panion License Agreement on November 21, 2018 if we
Akebia Therapeutics, Inc.
| Form 10-Q | Page 90
−Removed: of our obligation to use commercially reasonable efforts to commercialize Auryxia outside the U.S.
+Added: did not cure the breach alleged by Panion, specifically, that we failed to use commercially reasonable best efforts to commercialize Auryxia outside the U.S.
+Added: We disagreed with Panion’s claims, and the parties entered discussions to resolve this dispute.
+Added: On October 24, 2018, prior to the consummation of the Merger, we and Panion entered into a letter agreement, or the Panion Letter Agreement , pursuant to which Panion agreed to rescind any and all prior termination threats or notices relating to the Panion License Agreement and waived its rights to terminate the license agreement based on any breach by us of our obligation to use commercially reasonable efforts to commercialize Auryxia outside the U.S.
until the parties executed an amendment to the Panion License Agreement in accordance with the terms of the Panion Letter Agreement, following consummation of the Merger.
8 unchanged sentences
trade policy on tariffs could have a material adverse impact on our business, financial condition and results of operations.
−Removed: Since February 2025, the Trump Administration has imposed a series of tariff-related actions against U.S.
+Added: In 2025, the Trump Administration has initiated a series of tariff-related actions against U.S.
trading partners.
−Removed: In February 2025, the Trump Administration imposed a 25% tariff on Canada and Mexico for goods not covered by the United States-Mexico-Canada Agreement, or the USMCA , and a 20% tariff on China.
−Removed: On April 2, 2025, the President imposed a 10% “baseline” reciprocal tariff on all U.S.
+Added: On April 2, 2025, the President issued an executive order announcing a “baseline” reciprocal tariff of 10% on all U.S.
trading partners effective April 5, 2025, and higher individualized reciprocal tariffs on 57 countries (with certain product exemptions for pharmaceutical-related products, among others).
−Removed: The Trump Administration has announced trade agreements with several countries – including China and the EU – with baseline tariffs ranging from 10% to 20%.
−Removed: On July 31, 2025, President Trump announced new reciprocal tariff rates for all U.S.
−Removed: trading partners.
−Removed: In response to the U.S.
−Removed: tariff changes, certain foreign countries, including China, have imposed retaliatory measures.
−Removed: Sustained uncertainty about, or the further escalation of, trade and political tensions between the United States and China could result in a disadvantageous research and manufacturing environment in China, particularly for U.S.
−Removed: based companies, including retaliatory restrictions that hinder or potentially inhibit our ability to rely on contract development and manufacturing organizations, or CDMO s, and other service providers that operate in China.
−Removed: Separately, on April 16, 2025, the U.S.
−Removed: Department of Commerce announced an investigation under Section 232 of the Trade Expansion Act of 1962 into imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, active pharmaceutical ingredients, and related chemicals.
−Removed: President Trump has indicated he may impose tariffs of up to 200% on pharmaceutical products pursuant to this investigation.
+Added: Previously, the administration had imposed a 25% tariff on Canada and Mexico for goods not covered by the United States-Mexico-Canada Agreement, or USMCA, and tariffs equaling 20% on China.
+Added: In response, several countries threatened retaliatory measures, including Canada and China, which then imposed retaliatory tariffs.
+Added: Prior to when the country-specific reciprocal tariffs were scheduled to take effect, the administration delayed the effective date of such tariffs for all countries except China.
+Added: Several countries, including the United Kingdom, Japan and South Korea, among others, as well as the European Union, have reached deals with the U.S.
+Added: that include reduced tariff rates and other measures.
+Added: President Trump also issued an Executive Order detailing new reciprocal tariff rates for individual countries that took effect on August 7, 2025.
+Added: The new reciprocal rates, which are consistent with the rates reflected in the trade deals already announced, range from 10% to 41%.
+Added: The new rates do not apply to Canada, China, Mexico and a few other countries.
+Added: and China reached a framework agreement that resulted in the suspension of the higher reciprocal tariffs on China until November 10, 2026.
+Added: For China, the 10% baseline reciprocal tariff announced in April remains in effect, in addition to a minimum of an additional 10%, effective November 10, 2025.
+Added: For Mexico, the rate remains 25% for goods that are not covered by the USMCA, and for Canada, the rate is 45% for goods that are not covered by the USMCA.
+Added: Certain countries, including Japan, South Korea and the United Kingdom, as well as the European Union, have reached agreements with the U.S.
+Added: that cap pharmaceutical tariffs at 15%.
+Added: Separately, in April 2025, the U.S.
+Added: Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into the impact on U.S.
+Added: national security of the imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, active pharmaceutical ingredients, and related chemicals.
+Added: On September 25, 2025, via a post on Truth Social, the President announced that, beginning October 1, 2025, all branded or patented drugs imported in the U.S.
+Added: would face a 100% tariff.
+Added: The President indicated that the tariffs could be avoided by building pharmaceutical manufacturing facilities in the U.S.
+Added: Thereafter, the President delayed the October 1st effective date of these tariffs and announced that the administration had “begun preparing” tariffs on manufacturers that do not build in the U.S.
+Added: or enter into a most-favored-nation drug pricing agreement with the administration.
+Added: Certain trading partners, including the European Union, South Korea and Japan, negotiated exemptions from the Section 232 tariffs on pharmaceuticals.
+Added: We currently manufacture all of our Vafseo drug substance and drug product in China and conduct certain research activities in China.
+Added: Sustained uncertainty about, or the further escalation of, trade and political tensions between the United States and
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 91
+Added: China could result in a disadvantageous research and manufacturing environment in China, particularly for U.S.
+Added: based companies, including retaliatory restrictions that hinder or potentially inhibit our ability to rely on contract development and manufacturing organizations, or CDMOs, and other service providers that operate in China, including our current Vafseo manufacturers.
Our business may be negatively affected by these tariffs and any new tariff actions or trade restrictions and the underlying uncertainty and supply chain disruptions created thereby.
10 unchanged sentences
Trade tensions and conflicts between the U.S.
−Removed: and China, Europe, Canada or other countries have recently been escalating and, as such, we are exposed to the possibility of product supply disruption and increased costs and expenses in the
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 89
−Removed: event of changes to the laws, rules, regulations and policies of the governments of the U.S., China, Europe, Canada or other countries, trade agreement disputes or due to geopolitical unrest and unstable economic conditions.
+Added: and China, Europe, Canada or other countries have recently been escalating and, as such, we are exposed to the possibility of product supply disruption and increased costs and expenses in the event of changes to the laws, rules, regulations and policies of the governments of the U.S., China, Europe, Canada or other countries, trade agreement disputes or due to geopolitical unrest and unstable economic conditions.
In addition, certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements or proposed legislation by the U.S.
2 unchanged sentences
lawmakers called for investigations into and the imposition of possible economic sanctions against Chinese biotechnology companies WuXi AppTec and WuXi Biologics, or collectively WuXi , over alleged ties to the Chinese military.
+Added: In addition, the U.S.
+Added: Department of Commerce’s Bureau of Industry and Security, or BIS , recently published an interim final rule, referred to as the “Affiliates Rule,” which expands the scope of BIS export restrictions to include entities with 50% or greater ownership, in the aggregate, by one or more entities listed on the BIS entity list.
Escalating tensions between the United States and China may prevent or hinder the export of materials or technical information between us and our CDMO and third parties, such as pharmaceutical manufacturers.
These third parties may voluntarily require compliance or supply chain requirements that go above and beyond potential legislation to address perceived risk of “pass through,” which would make it difficult for us to operate our business.
−Removed: In addition, in September 2024 during the 118 th Congress, the U.S.
−Removed: House of Representatives passed the BIOSECURE Act (H.R.
−Removed: This bill names the following as biotechnology companies of concern:
−Removed: BGI, MGI, Complete Genomics, WuXi AppTec, and WuXi Biologics.
−Removed: The Senate advanced a substantially similar bill (S.
−Removed: 3558) but it did not pass.
−Removed: The Senate bill named the following as biotechnology companies of concern:
−Removed: BGI, MGI, Complete Genomics, WuXi AppTec, and any subsidiary, parent affiliate, or successor of such entities.
−Removed: If this legislation had been enacted into law, and while both bills had certain grandfather provision, the legislation would have potentially restricted the ability of U.S.
−Removed: biotechnology companies like ours to purchase services or products from, or otherwise collaborate with, specifically named Chinese biotechnology companies, including WuXi, and it would have authorized the U.S.
−Removed: government to impose such restrictions on entities' transactions with additional Chinese biotechnology companies as a condition of U.S.
−Removed: government contract, grant and loan funding.
−Removed: We anticipate these bills will be reintroduced during the 119 th Congress but, currently, they have not been introduced in either chamber.
+Added: In addition, in 2024, the U.S.
+Added: Congress considered legislation widely referred to as the BIOSECURE Act .
+Added: If this legislation had been enacted into law, it would have prohibited, subject to limited exceptions, the direct or indirect use of U.S.
+Added: federal government contract, grant, and loan funds for purchasing biotechnology equipment and services from certain Chinese biotechnology companies, possibly including WuXi entities.
+Added: On October 9, 2025, the U.S.
+Added: Senate passed a revised version of the BIOSECURE legislation as part of its National Defense Authorization Act for FY 2026.
+Added: Instead of specifying particular Chinese entities for restrictions, the Senate bill would initially target biotechnology companies that have been identified on the so-called 1260H List by the U.S.
+Added: Department of Defense as Chinese Military Companies Operating in the United States.
+Added: This list currently includes BGI Group, BGI Genomics Co., Ltd., Forensic Genomics International, and MGI Tech Co., Ltd., but does not include the WuXi entities.
+Added: The legislation would allow for other biotechnology companies, possibly including WuXi entities, to be added to the federal funding prohibitions at a later time.
+Added: House of Representatives has passed a version of the bill that does not contain similar biotechnology provisions, so it is not currently known whether the House or Senate language or other language or neither will become law.
If these bills become law, or similar laws are passed, they would have the potential to severely restrict the ability of companies like ours to contract with certain Chinese biotechnology companies of concern without losing the ability to contract with, or otherwise receive funding from, the U.S.
Such disruptions could have adverse effects on our ability to commercialize Auryxia and Vafseo or the development of our product candidates and our business operations.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 92
Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase the cost of manufacturing our products and product candidates, affect the demand for our products, the competitive position of our products or product candidates, and import or export of raw materials and finished product candidate used in our preclinical studies and clinical trials, particularly with respect to any product candidates and materials that we import from China and Canada, including pursuant to our manufacturing service arrangements with WuXi STA and Patheon.
−Removed: If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if either the U.S., Chinese, European, Canadian or other government takes retaliatory trade actions due to the recent trade tensions, such changes could have an adverse effect on our business, financial condition and results of operations.
+Added: If any new tariffs, export controls, legislation and/or regulations are implemented, or if existing trade agreements are renegotiated or, in particular, if the U.S., Chinese, European, Canadian or other governments take retaliatory trade actions due to the recent trade tensions, such changes could have an adverse effect on our business, financial condition and results of operations.
Risks Related to our Intellectual Property
13 unchanged sentences
Changes in the patent laws or the interpretation of the patent laws in the U.S.
−Removed: and other jurisdictions
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 90
−Removed: may diminish the value of our patents or narrow the scope of our patent protection.
+Added: and other jurisdictions may diminish the value of our patents or narrow the scope of our patent protection.
Accordingly, the patents we own or license may not be sufficiently broad to prevent others from practicing our technologies or from developing competing products.
14 unchanged sentences
The laws of the European Patent Convention, for example, provide for post-grant opposition procedures that permit competitors to challenge, or oppose, our European patents administratively at the European Patent Office, or EPO .
−Removed: We may become involved in addressing patentability objections based on third party submission of references, or we may become involved in defending our patent rights in oppositions, derivation proceedings, reexamination, inter partes review, post grant review, interference proceedings or other patent office proceedings or litigation, in the U.S.
+Added: We may become involved in addressing patentability objections based on third party submission of references, or we may become involved in defending our patent rights in oppositions, derivation proceedings, reexamination, inter partes review,
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 93
+Added: post grant review, interference proceedings or other patent office proceedings or litigation, in the U.S.
or elsewhere, challenging our patent rights or the patent rights of others.
13 unchanged sentences
In addition, in some cases, we share certain ownership and publication rights to data relating to some of our products and product candidates with research collaborators, licensees and other third parties.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 91
−Removed: maintain the confidentiality of this information, our ability to receive patent protection or protect our trade secrets or other proprietary information will be at risk.
+Added: If we cannot maintain the confidentiality of this information, our ability to receive patent protection or protect our trade secrets or other proprietary information will be at risk.
We may not be able to protect our intellectual property rights throughout the world.
13 unchanged sentences
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage for our products and product candidates from the intellectual property that we develop or license.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 94
The intellectual property that we own or have licensed and related non-patent exclusivity relating to our current and future products is, and may be, limited, which could adversely affect our ability to compete in the market and adversely affect the value of Auryxia, Vafseo or other future products.
13 unchanged sentences
to the first sponsor to gain approval of an NDA for an NCE.
−Removed: A drug is an NCE if the FDA has not previously approved any other new drug containing the same active moiety, which consists of the molecule(s) or ion(s) responsible for the action of the drug substance (but not including those portions of the molecule that cause it to be a salt or
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 92
−Removed: ester or which are not bound to the molecule by covalent or similar bonds).
+Added: A drug is an NCE if the FDA has not previously approved any other new drug containing the same active moiety, which consists of the molecule(s) or ion(s) responsible for the action of the drug substance (but not including those portions of the molecule that cause it to be a salt or ester or which are not bound to the molecule by covalent or similar bonds).
Vafseo was granted NCE status following its approval in March 2024 and received a five-year NCE exclusivity.
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In addition to NCE, in the U.S., the FDA has the authority to grant additional regulatory exclusivity protection for approved drugs where the sponsor conducts specified testing in pediatric or adolescent populations.
−Removed: If granted, this pediatric exclusivity may provide an additional six months which are added to the term of any non-patent exclusivity that has been awarded as well as to the regulatory protection related to the term of a relevant patent, to the extent these protections have not already expired.
+Added: If granted, this pediatric exclusivity may provide an additional six months which are added to the term of any non-patent exclusivity that has been awarded as
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 95
+Added: well as to the regulatory protection related to the term of a relevant patent, to the extent these protections have not already expired.
In addition, foreign regulatory authorities may change their approval policies and new regulations may be enacted regarding non-patent exclusivity.
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The revisions may, however, have a significant impact on the pharmaceutical industry and our business in the long term.
+Added: On June 4, 2025, after almost two years of negotiations among the EU Member States, the Council of the European Union adopted its position on the proposed overhaul of the EU general pharmaceutical legislative framework, which is known as the new Pharma Package.
+Added: This proposal will now be the subject of additional negotiations and technical meetings, with the objective of reaching agreement on issues such as the regulatory data protection framework and the access and supply obligations.
+Added: At this point, it appears that the period of market exclusivity for innovator products may be reduced from two years to one, exclusions from patent infringement for studies and trials will likely expand, and there will be a new obligation to ensure sufficient supply of medicines.
We cannot assure you that Auryxia, Vafseo or any of our potential future products will obtain such pediatric exclusivity, NCE exclusivity or any other market exclusivity in the U.S., EU or any other territory, or that we will be the first to receive the respective regulatory approval for such drugs so as to be eligible for any non-patent exclusivity protection.
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as of March 20, 2025.
−Removed: It is possible that we may receive
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 93
−Removed: Paragraph IV certification notice letters from additional ANDA filers and may not ultimately be successful in an ANDA litigation.
+Added: It is possible that we may receive Paragraph IV certification notice letters from additional ANDA filers and may not ultimately be successful in an ANDA litigation.
While we expect that the availability of the authorized generic version of Auryxia and any additional generic versions of Auryxia will negatively impact our net product revenue for Auryxia and our results of operations, it is difficult to estimate the impact of generics on Auryxia net product revenue, and if the impact is greater than we currently anticipate, it may materially adversely impact our business and results of operations.
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If we are required to defend against suits brought by third parties, or if we sue third parties to protect our rights, we may be required to pay substantial litigation costs, and our management’s attention may be diverted from operating our business.
−Removed: In addition, any legal action against our licensor, licensees or us that seeks damages or an injunction of commercial activities relating to Auryxia, Vafseo or any product candidates or other technologies, including those that may be in-licensed or acquired, could subject us to monetary liability, a temporary or permanent injunction preventing the development, marketing and sale of such products or such technologies, and/or require our licensor, licensees or us to obtain a license to continue to develop, market or sell such products or other technologies.
+Added: In addition, any legal action against our licensor, licensees or us that
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 96
+Added: seeks damages or an injunction of commercial activities relating to Auryxia, Vafseo or any product candidates or other technologies, including those that may be in-licensed or acquired, could subject us to monetary liability, a temporary or permanent injunction preventing the development, marketing and sale of such products or such technologies, and/or require our licensor, licensees or us to obtain a license to continue to develop, market or sell such products or other technologies.
In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.
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If we are not successful in such proceedings, FibroGen could try to claim that our products infringe their patent rights.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 94
Third parties, including FibroGen, may in the future claim that our products and product candidates and other technologies infringe upon their patents and may challenge our ability to commercialize Auryxia and Vafseo.
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If such a license is necessary and a license under the applicable patent is unavailable on commercially reasonable terms, or at all, our ability to commercialize our product or product candidate may be impaired or delayed, which could in turn significantly harm our business.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 97
Further, defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
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In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies.
−Removed: We may be subject to claims that we or our employees, consultants or independent contractors have
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 95
−Removed: inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers.
+Added: We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers.
We may also be subject to claims that former employees, collaborators or other third parties have an ownership interest in our patents or other intellectual property.
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Specifically, following receipt of the CRL, we implemented a reduction of our workforce in April and May 2022 by approximately 42% across all areas of our Company (47% inclusive of the closing of the majority of open positions), including several members of management.
−Removed: In November 2022, we also implemented a reduction of our workforce, by approximately 14% consisting of individuals within our commercial organization as a result of our decision to shift to a strategic account management focused model for our commercial efforts.
+Added: In November 2022, we
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 98
+Added: also implemented a reduction of our workforce, by approximately 14% consisting of individuals within our commercial organization as a result of our decision to shift to a strategic account management focused model for our commercial efforts.
Losing members of management and other key personnel could subject us to a number of risks, including the failure to coordinate responsibilities and tasks, the necessity to create new management systems and processes, the impact on corporate culture, and the retention of historical knowledge.
−Removed: Furthermore, replacing executives, senior managers and other key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop and commercialize Auryxia, Vafseo and any product candidates.
−Removed: Our future financial performance and our ability to develop and commercialize Auryxia and Vafseo and to compete effectively will depend, in part, on our ability to manage any future growth effectively.
+Added: Furthermore, replacing executives, senior managers and other key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop and commercialize Auryxia, Vafseo and our product candidates.
+Added: Our future financial performance and our ability to develop and commercialize Auryxia, Vafseo and our product candidates and to compete effectively will depend, in part, on our ability to manage any future growth effectively.
To that end, we must be able to hire, train, integrate, and retain additional qualified personnel with sufficient experience.
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If we are unable to successfully manage our supply obligations, our ability to commercialize our products or supply such products to our partners could have a material adverse effect on our relationships with our partners and our results of operations.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 96
−Removed: Our future financial performance and our ability to commercialize Auryxia and Vafseo, if and where approved, and to compete effectively will depend, in part, on our ability to manage any future growth effectively.
+Added: Our future financial performance and our ability to commercialize Auryxia and Vafseo and to compete effectively and to continue to develop our products and product candidates will depend, in part, on our ability to manage any future growth effectively.
This future growth will impose significant added responsibilities on the business and members of management.
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We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully managing and, as applicable, growing our Company.
−Removed: In addition, we may need to adjust the size of our workforce as a result of changes to our expectations for our business, which can result in management being required to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth-related activities and related expenses.
+Added: In addition, if and as we increase our development activities, we expect to expand the teams, infrastructure, and processes necessary to support these efforts.
+Added: Scaling our development activities will require recruiting, training, and integrating new personnel, as well as enhancing cross-functional coordination, which may introduce additional operational complexity.
+Added: If we are unable to successfully grow and integrate these teams or adapt our processes to meet the demands of increased development activity, our ability to advance our product candidates and achieve our strategic objectives could be adversely affected.
+Added: Furthermore, we may need to adjust the size of our workforce as a result of changes to our expectations for our business, which can result in management being required to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth-related activities and related expenses.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 99
Further, we rely on independent third parties to provide certain services to us.
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In addition, our conclusion that we have a material weakness could give rise to increased scrutiny, review, audit and investigation over our accounting controls and procedures, which could then lead to additional areas of deficiency or errors in our financial statements.
−Removed: We will need to continue to dedicate internal resources, engage outside consultants and maintain a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to remediate the material
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 97
−Removed: weakness relating to our accounting for inventory and inventory related transactions described above and any future control deficiencies or material weaknesses, and improve control processes as appropriate, validate through testing that controls are functioning as documented and maintain a continuous reporting and improvement process for internal control over financial reporting.
+Added: We will need to continue to dedicate internal resources, engage outside consultants and maintain a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to remediate the material weakness relating to our accounting for inventory and inventory related transactions described above and any future control deficiencies or material weaknesses, and improve control processes as appropriate, validate through testing that controls are functioning as documented and maintain a continuous reporting and improvement process for internal control over financial reporting.
If we are not able to correct material weaknesses or deficiencies in internal controls in a timely manner or otherwise comply with the requirements of Section 404 in a timely manner, our ability to record, process, summarize and report financial information accurately and within applicable time periods may be adversely affected, and we could be subject to sanctions or investigations by the Securities Exchange Commission, or the SEC , the Nasdaq Stock Market or other regulatory authorities as well as stockholder litigation which, even if resolved in our favor, would require additional financial and management resources and could adversely affect the market price of our common stock.
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Furthermore, if we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed.
−Removed: Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock and could also affect our ability to raise capital to fund future business initiatives.
+Added: Inferior internal controls could also cause investors to lose
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 100
+Added: confidence in our reported financial information, which could have a negative effect on the trading price of our common stock and could also affect our ability to raise capital to fund future business initiatives.
Security breaches and unauthorized use of our information technology systems and information, or the information technology systems or information in the possession of our collaborators, contractors and other third parties, could damage the integrity of our clinical trials, impact our regulatory filings, compromise our ability to protect our intellectual property, and subject us to regulatory actions that could result in significant fines or other penalties.
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Although we take steps to manage and avoid these risks and to be prepared to respond to attacks, our preventive and any remedial actions may not be successful and no such measures can eliminate the possibility of the systems’ improper functioning or the improper access or disclosure of confidential or personally identifiable information such as in the event of cyberattacks.
−Removed: Security breaches, whether through physical or electronic break-ins, computer viruses, ransomware, impersonation of authorized users, attacks by hackers or
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 98
−Removed: other means, can create system disruptions or shutdowns that impact our business operations or the unauthorized disclosure of confidential information.
+Added: Security breaches, whether through physical or electronic break-ins, computer viruses, ransomware, impersonation of authorized users, attacks by hackers or other means, can create system disruptions or shutdowns that impact our business operations or the unauthorized disclosure of confidential information.
Although we believe our collaborators, vendors and service providers, such as our CROs, take steps to manage, mitigate and avoid information security risks and respond to attacks, we may be adversely affected by attacks against our collaborators, vendors or service providers, and we may not have adequate contractual remedies against such collaborators, vendors and service providers to remedy any harm to our business caused by such event.
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Cyber-attacks have become more prevalent and much harder to detect and defend against.
−Removed: Because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage systems change frequently and continuously become more sophisticated, including the use of artificial intelligence to generate sophisticated spoofed emails and deep fake voice and video, often are not recognized until launched against a target and may be difficult to detect for a long time, we may be unable to anticipate these techniques or to implement adequate preventive or detective measures, and we might not immediately detect such incidents and the damage caused by such incidents.
+Added: Because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage systems change frequently and continuously become more sophisticated, including the use of artificial intelligence
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 101
+Added: to generate sophisticated spoofed emails and deep fake voice and video, often are not recognized until launched against a target and may be difficult to detect for a long time, we may be unable to anticipate these techniques or to implement adequate preventive or detective measures, and we might not immediately detect such incidents and the damage caused by such incidents.
Such attacks, whether successful or unsuccessful, or other compromises with respect to our information security and the measures we implement to prevent, detect and respond to them, could:
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equivalents, including those related to insider trading.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 99
We conducted our global clinical trials for Vafseo, and may in the future conduct additional trials, in countries where corruption is prevalent, and violations of any of these laws by our personnel or by any of our vendors or agents, such as our CROs or CMOs, could have a material adverse impact on our clinical trials and our business and could result in criminal or civil fines and sanctions.
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In addition, the FCPA presents unique challenges in the pharmaceutical industry because in many countries’ hospitals are operated by the government, and doctors and other hospital employees are considered foreign government officials.
−Removed: Certain payments made by pharmaceutical companies, or on their behalf by CROs, to hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.
+Added: Certain payments made by pharmaceutical companies, or on their behalf by CROs, to
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 102
+Added: hospitals in connection with clinical trials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.
Additionally, the UK Bribery Act applies to our global activities and prohibits bribery of private individuals as well as public officials.
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Our financial statements include long-lived assets, including goodwill as a result of the Merger.
−Removed: Other long-lived assets, including property and equipment, right-of-use assets or goodwill, could become impaired in the future under certain
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 100
+Added: Other long-lived assets, including property and equipment, right-of-use assets or goodwill, could become impaired in the future under certain conditions.
Any potential future impairment of property and equipment, our right-of-use assets or goodwill may significantly impact our results of operations and financial condition.
−Removed: As of June 30, 2025, we had approximately $59.0 million of goodwill from the Merger, $1.7 million of property and equipment and $6.0 million right-of-use assets.
+Added: As of September 30, 2025, we had approximately $59.0 million of goodwill from the Merger, $1.5 million of property and equipment and $4.8 million right-of-use assets.
In accordance with ASC 350, Goodwill and Other , we are required annually for goodwill, or more frequently upon certain indicators of impairment, to review our estimates and assumptions underlying the fair value of our goodwill.
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To the extent we conclude our long-lived assets have become impaired, we may be required to incur material write-offs relating to such impairment and any such write-offs could have a material impact on our future operating results and financial position.
−Removed: The estimates, judgments and assumptions used in our impairment analyses, and the results of our analyses, are discussed in Note 2, Summary of Significant Accounting Policies , to our unaudited condensed consolidated financial statements in Part I, Item 1.
+Added: The estimates, judgments and
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 103
+Added: assumptions used in our impairment analyses, and the results of our analyses, are discussed in Note 2, Summary of Significant Accounting Policies , to our unaudited condensed consolidated financial statements in Part I, Item 1.
Financial Statements and Supplementary Data of this Form 10-Q.
If these estimates, judgments and assumptions change in the future, additional impairment charges related to plant and equipment, and right-of-use assets or goodwill could be recorded in the future, which could materially impact our financial position, certain of our material agreements, and our future operating results.
−Removed: If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of Auryxia or Vafseo.
+Added: If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of Auryxia or Vafseo or affect the development of our product candidates.
We face an inherent risk of product liability as a result of the clinical and commercial use of Auryxia and Vafseo and our product candidates.
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• a decline in our stock price.
−Removed: Failure to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop.
+Added: Failure to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the development of our product candidates or commercialization of products we develop.
We currently carry product liability insurance that we believe is appropriate for our Company.
1 unchanged sentence
Our insurance policies also have various exclusions, and we may be subject to a product liability claim for which we have insufficient or no coverage.
−Removed: If we have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 101
−Removed: by our insurance, we may not have, or be able to obtain, sufficient capital to pay such amounts.
+Added: If we have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, we may not have, or be able to obtain, sufficient capital to pay such amounts.
In addition, insurance coverage is becoming increasingly expensive, and we may not be able to maintain insurance coverage at a reasonable cost.
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Our testing, or the testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls that we would be required to remediate in a timely manner.
−Removed: If we are not able to comply with the requirements of the Sarbanes-Oxley Act, we could be subject to sanctions or investigations by the SEC, the Nasdaq Capital Market or other regulatory authorities, which would require additional financial and management resources and could adversely affect the market price of our securities.
+Added: If we are not able to comply with the requirements of the Sarbanes-Oxley Act, we could be subject to sanctions or investigations by the SEC, the Nasdaq Capital Market or other regulatory authorities, which
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 104
+Added: would require additional financial and management resources and could adversely affect the market price of our securities.
Furthermore, if we cannot provide reliable financial reports or prevent fraud, including as a result of remote working by our employees, our business and results of operations would likely be materially and adversely affected.
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On December 12, 2018, we completed the Merger, which we believe has resulted in an ownership change under Section 382.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 102
Future changes in our stock ownership, many of which are outside of our control, could result in an additional ownership change under Section 382.
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Our Charter designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
−Removed: Our Charter provides that, subject to limited exceptions, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (iii) any action asserting a claim against us arising pursuant to any provision of the DGCL our Charter or our Bylaws, or (iv) any other action asserting a claim against us, our directors, officers or other employees that is governed by the internal affairs doctrine.
+Added: Our Charter provides that, subject to limited exceptions, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 105
+Added: a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (iii) any action asserting a claim against us arising pursuant to any provision of the DGCL our Charter or our Bylaws, or (iv) any other action asserting a claim against us, our directors, officers or other employees that is governed by the internal affairs doctrine.
Under our Charter, this exclusive forum provision will not apply to claims that are vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery of the State of Delaware, or for which the Court of Chancery of the State of Delaware does not have subject matter jurisdiction.
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Monetary damages or any other adverse judgment would have a material adverse effect on our business and financial position.
−Removed: In addition, if other resolution or actions taken as a result of legal proceedings were to restrain our ability to operate or market
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 103
−Removed: our products and services, our consolidated financial position, results of operations or cash flows could be materially adversely affected.
+Added: In addition, if other resolution or actions taken as a result of legal proceedings were to restrain our ability to operate or market our products and services, our consolidated financial position, results of operations or cash flows could be materially adversely affected.
We could also suffer an adverse impact on our reputation, negative publicity and a diversion of management’s attention and resources, which could have a material adverse effect on our business.
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Delisting could also cause a loss of confidence of potential industry partners, lenders, and employees, which could further harm our business and our future prospects.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 106
The issuance of additional shares of our common stock or the sale of shares of our common stock by any of our directors, officers or significant stockholders will dilute our stockholders’ ownership interest in Akebia and may cause the market price of our common stock to decline.
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These sales, or the perception in the market that the holders of a large number of shares intend to sell such shares, could reduce the market price of our common stock.
−Removed: As of June 30, 2025 and based on the amounts reported in the most recent filings made under Section 13(g) of the Exchange Act, BlackRock beneficially owned approximately 5.8% of our outstanding shares of common stock and the Vanguard Group, or Vanguard , beneficially owned approximately 4.8% of our outstanding shares of common stock.
+Added: As of September 30, 2025 and based on the amounts reported in the most recent filings made under Section 13(g) of the Exchange Act, BlackRock beneficially owned approximately 5.7% of our outstanding shares of common stock and the Vanguard Group, or Vanguard , beneficially owned approximately 4.8% of our outstanding shares of common stock.
By selling a large number of shares of common stock, BlackRock or Vanguard could cause the price of our common stock to decline.
−Removed: In addition, as of June 30, 2025, CSL Vifor beneficially owned 7,571,429 shares of common stock, which have not been registered pursuant to the Securities Act and were issued and sold in reliance upon the exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder, but if they are registered in the future, those shares would become freely tradable and, if a large portion of such shares are sold, could cause the price of our common stock to decline.
+Added: In addition, as of September 30, 2025, CSL Vifor beneficially owned 7,571,429 shares of common stock, which have not been registered pursuant to the Securities Act and were issued and sold in reliance upon the exemption from registration contained in Section 4(a)(2) of the Securities Act and Rule 506 promulgated thereunder, but if they are registered in the future, those shares would become freely tradable and, if a large portion of such shares are sold, could cause the price of our common stock to decline.
Further, we entered into a warrant agreement with Kreos Capital VII Aggregator SCSp, an affiliate of Kreos, or the Warrant Holder , pursuant to which (i) we issued a warrant to the Warrant Holder to purchase 3,076,923 shares of our common stock, or the Initial Warrant , at an exercise price per share of $1.30 (subject to standard adjustments for stock splits, stock dividends, rights offerings and pro rata distributions), or the Exercise Price , and (ii) we issued a warrant to the Warrant Holder to purchase 1,153,846 shares of our common stock, at an exercise price per share equal to the Exercise Price.
10 unchanged sentences
In addition, we currently have on file with the SEC a shelf registration statement on Form S-3, which allows us to offer and sell up to $250.0 million in registered securities, such as common stock, preferred stock, debt securities, warrants and units, from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale, including a sales agreement prospectus that covers the offering, issuance and sale by us of up to a maximum aggregate offering price of up to $75.0 million of our common stock that may be issued and sold from time to time under a sales agreement with Jefferies LLC, of which $32.0 million remains available for future issuance and sale.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 104
Sales of substantial amounts of shares of our common stock or other securities by our employees or our other stockholders or by us under our shelf registration statement, pursuant to at-the-market offerings or otherwise, could dilute our stockholders, lower the market price of our common stock and impair our ability to raise capital through the sale of equity securities.
Our executive officers, directors and principal stockholders maintain the ability to significantly influence all matters submitted to stockholders for approval.
−Removed: As of June 30, 2025, our executive officers, directors and principal stockholders, in the aggregate, beneficially owned shares representing a significant percentage of our capital stock.
+Added: As of September 30, 2025, our executive officers, directors and principal stockholders, in the aggregate, beneficially owned shares representing a significant percentage of our capital stock.
As a result, if these stockholders were to choose to act together, they would be able to significantly influence all matters submitted to our stockholders for approval, as well as our management and affairs.
1 unchanged sentence
This concentration of voting power could delay or prevent an acquisition of our Company on terms that other stockholders may desire.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 107
Provisions in our organizational documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
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As a result, capital appreciation, if any, of our common stock will be our stockholders’ sole source of gain for the foreseeable future.
−Removed: Akebia Therapeutics, Inc.
−Removed: | Form 10-Q | Page 105
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.