Licensing and Revenue - The company received an upfront payment of $10.0 million under the Medice License Agreement for Vafseo, with potential commercial milestone payments up to $100.0 million and tiered royalties ranging from 10% to 30% of annual net sales in the Medice Territory[100][103]. - The company is eligible to receive up to approximately $225.0 million in aggregate payments from MTPC based on the achievement of certain milestones, along with tiered royalty payments ranging from 13% to 20% on annual net sales of Vafseo in the MTPC Territory[109]. - The Vifor License Agreement included an upfront payment of $25.0 million and a profit-sharing arrangement where the company receives approximately 66% of the profits from Vafseo sales[112]. - The company recorded $5.4 million in license revenue related to royalties earned on net sales of Riona in Japan during the year ended December 31, 2024[125]. - The company is eligible to receive up to an additional $55.0 million upon the achievement of certain annual net sales milestones related to Riona[125]. - The company recorded $9.1 million in royalties due to Panion relating to the sales of Auryxia in the U.S. and JT and Torii net sales of Riona in Japan during the year ended December 31, 2024[129]. - The company is eligible to receive royalty payments based on a mid-single digit percentage of net sales of ferric citrate in licensed territories under the Panion Amended License Agreement[127]. Supply Chain and Manufacturing - The company relies on single-source suppliers for the manufacture of Auryxia, with pricing structured on a per-kilogram basis for the drug substance and tiered pricing for the drug product[97]. - The company has engaged Cardinal Health, Inc. as the exclusive third-party logistics distribution agent for commercial sales of Auryxia and Vafseo[98]. - The company has established CMO relationships for the supply of Auryxia to ensure sufficient material for ongoing commercial sales and clinical trials[97]. - The company entered into a supply agreement with Medice to supply Vafseo drug product for commercial and developmental use in the Medice Territory[106]. - The company controls all clinical and commercial manufacturing of praliciguat, which will be conducted by a third-party manufacturer[133]. Patent and Intellectual Property - The company holds 19 issued patents covering vadadustat, with expected expiration dates between 2027 and 2039[142]. - The company has exclusive rights under a series of patents and patent applications to commercialize Auryxia worldwide, with expected expiration dates between 2026 and 2030[145]. - The company has filed applications for patent term extensions for U.S. Patent Nos. 8,299,298, 8,093,423, 7,767,851, and 8,338,642 covering Auryxia due to FDA regulatory review delays[161]. - The company expects to apply for patent term extensions on issued patents covering future product candidates upon FDA or foreign regulatory approval[164]. - The company’s patent term extensions could be critical in maintaining market exclusivity for its products, potentially extending patent life by up to five years[160]. - Patent term restoration under the Hatch-Waxman Act can extend a patent by up to five years for time lost during development and FDA review[262]. Competition and Market Landscape - Auryxia competes in the hyperphosphatemia market against FDA-approved phosphate binders, including Renagel® and Renvela®, as well as newly approved XPHOZAH®[174]. - In the iron deficiency anemia market, Auryxia faces competition from over-the-counter oral iron and various intravenous iron formulations, including Feraheme® and Injectafer®[175]. - Vafseo competes with several established products, including Epogen® and Aranesp®, as well as new therapies like roxadustat and daprodustat in various markets[167][171]. - The company is aware of the competitive landscape, including potential new anemia therapies in development by other companies[169]. - The company faces significant competition from larger pharmaceutical firms with greater resources and R&D capabilities[165]. - The company is currently facing competition from products that may be less expensive or more effective than Auryxia[177]. - The revenue decline for Auryxia post-LoE may be slower than typical due to its inclusion in the ESRD bundle under Medicare Part B[180]. - The timing and number of generic versions entering the market will significantly impact future Auryxia revenues[180]. Regulatory and Clinical Trial Processes - Regulatory processes for drug approvals require substantial time and financial resources, impacting the development timeline[181]. - The FDA requires a 30-day waiting period after IND submission before clinical trials can commence, allowing for safety reviews[188]. - Clinical trials must comply with GCP requirements, including obtaining informed consent from all participants[201]. - The company must disclose clinical trial information on a public registry, with potential penalties for non-compliance[196]. - The FDA requires sponsors to develop and submit a diversity action plan (DAP) for each Phase 3 clinical trial, aimed at increasing diverse patient enrollment[203]. - The FDA's application fee for NDA submission in fiscal year 2025 is approximately $4.3 million, with an annual program fee of about $0.4 million per eligible prescription product[216]. - The FDA aims to review most NDAs within ten months of filing, with priority review products targeted for six months[218]. - The FDA may grant fast track designation for products addressing unmet medical needs in serious or life-threatening conditions[224]. - The FDA's review process includes a preliminary review within 60 days of receipt to determine if the application is sufficiently complete[217]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with cGMP and GCP requirements before NDA approval[219][221]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval to minimize risks associated with a product[222]. - The FDA's draft guidance in June 2023 aims to modernize clinical trial design and conduct, facilitating the development of medical products[204]. - The FDA's Pediatric Research Equity Act mandates that applications must include data to assess safety and effectiveness in pediatric populations[211]. - The FDA may designate a product as a breakthrough therapy if it shows substantial improvement over existing therapies for serious conditions[228]. - The FDA may designate a product for priority review, reducing the review time from ten months to six months for drugs that treat serious conditions and provide significant safety or effectiveness improvements[229]. - Accelerated approval can be granted based on clinical trials showing effects on surrogate endpoints, allowing quicker access to therapies for serious or life-threatening illnesses[230]. - New legislation allows the FDA to require confirmatory clinical trials to be underway before granting accelerated approval and mandates progress reports every six months[231]. - The FDA prefers randomized controlled trials for accelerated approval to ensure robust efficacy and safety assessments, particularly for oncology therapeutics[232]. - The FDA's review process includes a benefit-risk assessment, considering the severity of the condition and the adequacy of existing therapies[236]. - A Complete Response Letter (CRL) indicates deficiencies in an application, requiring substantial additional testing or information for reconsideration[237]. - An approval letter authorizes commercial marketing but may impose specific conditions, including post-approval trials and risk management mechanisms[238]. - The Ensuring Innovation Act mandates the FDA to publish action packages summarizing decisions on new drug approvals within 30 days[239]. - Post-approval requirements may include additional studies and monitoring to assess drug safety and effectiveness[240]. Data Privacy and Compliance - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose new privacy obligations on companies handling personal data[264]. - At least eighteen states have enacted privacy laws similar to the CCPA and CPRA, impacting data processing obligations[265]. - Companies face increasing lawsuits related to privacy violations, particularly concerning the use of web trackers and pixels[266]. - Non-compliance with privacy and data security laws could result in significant penalties, including fines and reputational harm[269]. Clinical Trials in the EU - The Clinical Trials Regulation (EU) No 536/2014 aims to simplify and streamline the authorization and conduct of clinical trials in the EU, requiring only a single application for trials conducted in multiple Member States[272]. - The maximum timeframe for the evaluation of a Marketing Authorization Application (MAA) under the centralized procedure is 210 days, with accelerated evaluation possible in exceptional public health cases, reducing the timeframe to 150 days[281]. - A marketing authorization is valid for five years and can be renewed based on a reevaluation of the risk-benefit balance, with the possibility of unlimited validity upon renewal[287]. - The EMA's PRIME scheme facilitates the development of product candidates for unmet medical needs, providing benefits such as early regulatory dialogue and accelerated assessment[278]. - Non-clinical studies must comply with GLP principles, ensuring the safety of new chemical or biological substances[271]. - The centralized procedure is compulsory for specific products, including orphan medicinal products and advanced therapy products, ensuring a single marketing authorization valid across all EU member states[280]. - The Pediatric Investigation Plan (PIP) is required for marketing authorization in the EU, covering all subsets of the pediatric population unless waivers are granted[279]. - The MA holder must establish a pharmacovigilance system to monitor the safety of medicinal products, including expedited reporting of serious adverse reactions[288]. - The manufacturing process for medicinal products in the EU is highly regulated, requiring compliance with EU GMP standards[290]. - Non-compliance with EU regulations may result in severe penalties, including delays in trial authorization and marketing approvals, product withdrawals, and criminal penalties[293].

Financial Performance - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and full-year revenues were $160.2 million compared to $194.6 million in 2023[6] - Auryxia net product revenues decreased to $44.4 million in Q4 2024 from $53.2 million in Q4 2023, and for the full year, revenues were $152.2 million compared to $170.3 million in 2023[6] - Net loss for Q4 2024 was $22.8 million, compared to a net income of $0.6 million in Q4 2023, and full-year net loss was $69.4 million compared to $51.9 million in 2023[12] - Product revenue, net for the year 2024 was $152.2 million, down 10.7% from $170.3 million in 2023[33] - Net loss for Q4 2024 was $22.8 million, compared to a net income of $0.6 million in Q4 2023[33] - Total assets decreased to $220.7 million in 2024 from $241.7 million in 2023[35] Expenses - Research and development expenses increased to $11.8 million in Q4 2024 from $9.9 million in Q4 2023, while full-year R&D expenses decreased to $37.7 million from $63.1 million in 2023[6] - Selling, general and administrative expenses rose to $27.7 million in Q4 2024 from $25.4 million in Q4 2023, and full-year SG&A expenses increased to $106.5 million from $100.2 million in 2023[6] - Operating expenses increased to $40.4 million in Q4 2024, up 11.8% from $36.2 million in Q4 2023[33] - Research and development expenses for the year 2024 were $37.7 million, down from $63.1 million in 2023[33] - Selling, general and administrative expenses increased to $106.5 million in 2024, compared to $100.2 million in 2023[33] Cash Position - Cash and cash equivalents as of December 31, 2024, were approximately $51.9 million, up from $42.9 million as of December 31, 2023[12] - Cash and cash equivalents as of December 31, 2024, were $51.9 million, an increase from $42.9 million in 2023[35] Product Development and Market Opportunities - Vafseo U.S. launch is progressing well, with expected net product revenues of approximately $10-$11 million for Q1 2025[1] - The VALOR Phase 3 clinical trial is expected to begin in the second half of 2025 to study Vafseo in non-dialysis CKD patients[6] - Vafseo has been recommended for symptomatic anemia in adults undergoing dialysis for CKD by the U.K. National Institute for Health and Care Excellence (NICE)[6] - More than 500 prescribers have written prescriptions for Vafseo, with an average of approximately 8 prescriptions per prescriber[4] - The company anticipates potential market opportunities for its products, including Vafseo and Auryxia, but faces risks from competition and regulatory decisions[29]

Core Insights - Akebia Therapeutics reported strong early results from the U.S. launch of Vafseo, expecting net product revenues of approximately $10-$11 million for Q1 2025 [1][2] - The company anticipates that its cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years [1][12] Vafseo U.S. Commercial Update - Vafseo shipments began on January 9, 2025, with the first prescription written on January 13, 2025 [6] - Three of the top four dialysis organizations in the U.S. have placed orders for Vafseo, and over 500 prescribers have written prescriptions, averaging about 8 prescriptions each [6] - Vafseo has been recommended for symptomatic anemia in adults undergoing dialysis for CKD by the U.K. National Institute for Health and Care Excellence (NICE) [6] Additional Key Business Updates - Akebia plans to initiate a Phase 3 clinical trial (VALOR) for Vafseo in late-stage CKD patients not on dialysis, with expectations to begin in the second half of 2025 [6][12] - The VOICE clinical trial has enrolled more than half of its target of 2,200 patients [6] Financial Results - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and full-year revenues were $160.2 million compared to $194.6 million in 2023 [6][7] - Auryxia net product revenues were $44.4 million in Q4 2024, down from $53.2 million in Q4 2023, and $152.2 million for the full year compared to $170.3 million in 2023 [6][7] - Research and development expenses increased to $11.8 million in Q4 2024 from $9.9 million in Q4 2023, while full-year R&D expenses decreased to $37.7 million from $63.1 million [12][35] Cash Position - Cash and cash equivalents as of December 31, 2024, were approximately $51.9 million, up from $42.9 million as of December 31, 2023 [12][37] - The company raised $18.4 million through share sales and accessed $9.3 million from the BlackRock Credit Agreement post year-end [12]

Core Viewpoint - Akebia Therapeutics, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 13, 2025, before market opening [1] Group 1: Financial Results Announcement - The financial results will be discussed in a conference call scheduled for March 13, 2024, at 8:00 a.m. ET [2] - Participants are encouraged to register in advance and join the call 15 minutes early to ensure timely connection [2] Group 2: Webcast Information - A live webcast of the conference call will be available on Akebia's Investors section of their website [3] - An online archive of the webcast will also be accessible via the same section of the website [3] Group 3: Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease [4] - The company was founded in 2007 and is headquartered in Cambridge, Massachusetts [4]

Company Overview - Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [4]. Financial Results Announcement - Akebia plans to release its financial results for the fourth quarter and full year ended December 31, 2024, on March 13, 2025, prior to the opening of financial markets [1]. Conference Call Details - A conference call will be held on March 13, 2024, at 8:00 a.m. ET to discuss the financial results and recent business highlights, with registration required for access [2]. - A live webcast of the conference call will be available on Akebia's website, along with an online archive of the webcast [3].

Company Overview - Akebia Therapeutics (NASDAQ: AKBA) is focused on developing treatments for kidney-related diseases, primarily utilizing its HIF platform [1]. Transition and Risks - The company is currently transitioning from its existing product Auryxia to a new product, Vafseo, which presents a significant risk for the company [1]. - Despite the risks associated with this transition, Vafseo is reportedly experiencing some early successes in the market [1].

Core Points - Akebia Therapeutics, Inc. granted options to purchase 130,763 shares of common stock to seven newly-hired employees as an inducement for employment [1][2] - The exercise price of the options is set at $2.24 per share, matching the closing price on the grant date [2] - The stock options will vest over four years, with 25% vesting on the first anniversary and the remaining 75% vesting quarterly, contingent on continued service [2] Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [3]

Core Insights - Akebia Therapeutics has secured commercial supply contracts for Vafseo® (vadadustat), achieving nearly 100% coverage of dialysis patients in the U.S. [2][7] - Vafseo tablets are now shipping in the U.S. for adult patients with anemia due to chronic kidney disease (CKD) on dialysis for at least three months [2][4] - The company plans to initiate a Phase 3 trial in mid-2025 to potentially expand Vafseo's label to include treatment for late-stage non-dialysis CKD patients [3][4] Commercial Developments - Vafseo began shipping to dialysis centers on January 9, 2025, with broad access secured through agreements with dialysis organizations [7] - Market research indicates that 99% of nephrologists would consider prescribing Vafseo, with 75% intending to do so within six months of availability [7] - Akebia has engaged with the FDA regarding a Phase 3 cardiovascular outcome study for late-stage CKD anemia patients not on dialysis, expected to start in mid-2025 [3][7] Financial Outlook - The CEO of Akebia believes the company is entering a transformational year with the U.S. market availability of Vafseo, which could become a new standard of care for CKD patients [4] - The potential market opportunity for expanding Vafseo's label into the non-dialysis population is estimated to be multiple billion dollars in the U.S. [4] - Akebia expects its existing cash resources and cash from operations to be sufficient to fund its current operating plan for at least two years [7][8]

Group 1 - Akebia Therapeutics, Inc. (AKBA) has been added to the Zacks Rank 5 (Strong Sell) List due to a 26.3% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Coca-Cola FEMSA, S.A.B. de C.V. (KOF) is also on the Zacks Rank 5 (Strong Sell) List, with a 10.5% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - DENTSPLY SIRONA Inc. (XRAY) has seen a 6.5% downward revision in the Zacks Consensus Estimate for its current year earnings over the last 60 days, leading to its inclusion in the Zacks Rank 5 (Strong Sell) List [2]

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease [3] - The company was founded in 2007 and is headquartered in Cambridge, Massachusetts [3] Upcoming Event - John Butler, the Chief Executive Officer of Akebia, will participate in a Fireside Discussion at the 36th Annual Piper Sandler Healthcare Conference on December 3, 2024, at 10:30 AM EST [1] - The Piper Sandler Healthcare Conference will be held from December 3-5, 2024, in New York [3] Webcast Information - A webcast of the presentation will be available in the "Investors" section of Akebia's website for six months following the conference [2]