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 ...

Chris Lau is an individual investor and economist with 30 years of experience covering life science, technology, and dividend-growth income stocks. He has degrees in Microbiology and Economics. Chris runs the investing group DIY Value Investing where he shares his top stock picks of undervalued stocks with catalysts for upside, dividend-income recommendations with quant and payment calendar tracking, high upside plays, and research requests to help you become a better do-it-yourself investor. Learn more. To ...