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]

Here are three stocks added to the Zacks Rank #5 (Strong Sell) List today:ATI Inc. (ATI) is a specialty manufacturing company. The Zacks Consensus Estimate for its current year earnings has been revised 5.2% downward over the last 60 days.Akebia Therapeutics, Inc. (AKBA) is a biopharmaceutical company. The Zacks Consensus Estimate for its current year earnings has been revised 26.3% downward over the last 60 days.Alta Equipment Group Inc. (ALTG) is an equipment dealership company. The Zacks Consensus Estima ...