One stock that might be an intriguing choice for investors right now is Akebia Therapeutics, Inc. (AKBA) . This is because this security in the Medical - Drugs space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective. This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the ...

CAMBRIDGE, Mass., March 25, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it will present data at the National Kidney Foundation Spring Clinical Meetings 2025 (NKF SCM25), which will take place in Boston, MA from April 10-13, 2025. Akebia-supported posters will be displayed at NKF SCM25 during Exhibit Hall hours. Cardiovascular Risk in Patients With DD-CKD Randomi ...

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5]. Offering Details - Akebia announced a public offering of 25,000,000 shares of common stock at a price of $2.00 per share, aiming to raise gross proceeds of $50.0 million before expenses [1]. - The underwriters have a 30-day option to purchase up to 3,750,000 additional shares at the public offering price [1]. - The offering is expected to close on March 21, 2025, pending customary closing conditions [1]. Underwriters - Leerink Partners and Piper Sandler & Co. are serving as joint bookrunning managers for the offering, with BTIG, LLC as the lead manager and H.C. Wainwright & Co. as co-manager [2]. Regulatory Compliance - The shares are being offered under a shelf registration statement filed with the SEC on September 3, 2024, which was declared effective on September 12, 2024 [2]. - A preliminary prospectus supplement has been filed with the SEC, and a final prospectus will also be filed [3]. Contact Information - For inquiries regarding the offering, contact details for Leerink Partners and Piper Sandler & Co. are provided [3].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by ki ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q4 2024 Earnings Conference Call March 13, 2025 8:00 AM ET Company Participants Mercedes Carrasco - Senior Director, IR John Butler - CEO Nick Grund - Chief Commercial Officer Erik Ostrowski - Chief Financial & Business Officer Conference Call Participants Allison Bratzel - Piper Sandler Julian Harrison - BTIG Ed Arce - H.C. Wainwright Operator Good day, and welcome to Akebia's Fourth Quarter 2024 Financial Results Call. At this time, all participants are in a listen- ...

Akebia Therapeutics (AKBA) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to break-even earnings per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -25%. A quarter ago, it was expected that this kidney disease treatment developer would post a loss of $0.05 per share when it actually produced a loss of $0.10, delivering a surprise of -100%.Over the last four ...

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]