Product Development and Market Launch - Vafseo® (vadadustat) is on track for U.S. market availability expected in January 2025[1] - Vafseo received TDAPA reimbursement approval, effective January 1, 2025, along with a Level II Healthcare Common Procedure Coding System code[4] - Akebia has partnered with U.S. Renal Care to initiate a trial evaluating mortality and hospitalization outcomes for dialysis patients taking Vafseo[2] - Akebia expects to enter into contracts with additional dialysis providers to increase coverage for Vafseo throughout 2024[25] - The company plans to establish Vafseo as the new oral standard of care for dialysis patients with anemia[25] Financial Performance - Total revenues for Q3 2024 were $37.4 million, down from $42.0 million in Q3 2023, with Auryxia® net product revenues at $35.6 million compared to $40.1 million[7] - Total revenues for Q3 2024 were $37,428,000, a decrease of 11.5% from $42,046,000 in Q3 2023[28] - Product revenue, net for Q3 2024 was $35,592,000, down from $40,118,000 in Q3 2023, reflecting a decline of 11.8%[28] - Net loss for Q3 2024 was $20.0 million, compared to $14.5 million in Q3 2023, including $4.4 million in non-cash interest expense[12] - Net loss for Q3 2024 was $20,039,000, compared to a net loss of $14,489,000 in Q3 2023, representing an increase in loss of 38.5%[28] Expenses and Cost Management - Cost of goods sold (COGS) decreased to $14.2 million in Q3 2024 from $18.0 million in Q3 2023, aided by a $3.7 million benefit from selling previously written-down inventory[9] - Research and development expenses were $8.5 million in Q3 2024, down from $13.3 million in Q3 2023, due to completed clinical trials and reduced costs[10] - Research and development expenses for Q3 2024 were $8,487,000, a decrease of 36.5% from $13,330,000 in Q3 2023[28] - Selling, general, and administrative expenses increased to $26.5 million in Q3 2024 from $22.7 million in Q3 2023, driven by preparatory activities for Vafseo[11] - Selling, general and administrative expenses increased to $26,516,000 in Q3 2024, up from $22,710,000 in Q3 2023, marking an increase of 16.4%[28] Cash Position - Cash and cash equivalents as of September 30, 2024, were approximately $34.0 million, expected to fund operations for at least two years[13] - Cash and cash equivalents as of September 30, 2024, were $34,019,000, down from $42,925,000 as of December 31, 2023[29] - Akebia's existing cash resources are expected to fund its current operating plan, including the U.S. Vafseo launch, for at least two years[25]

Vafseo® (vadadustat) on track for U.S. market availability expected in January 2025 Over 300,000 patients, representing approximately 60% of dialysis patient lives in the U.S., now covered under dialysis provider contracts for Vafseo Vafseo granted TDAPA reimbursement and issued a Level II Healthcare Common Procedure Coding System code Akebia to Host Conference Call at 8:00 a.m. ET on November 7CAMBRIDGE, Mass., Nov. 7, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical com ...

Akebia to Host Conference Call on November 7, 2024, at 8:00 a.m. ESTCAMBRIDGE, Mass., Nov. 1, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced plans to release its financial results for the third quarter ended September 30, 2024, on Thursday, November 7, 2024, prior to the open of financial markets.Akebia will host a conference call on Thursday, November 7, 2024, at 8:00 a.m. EST to discuss its financial results and recent business highlights. To access the call, please registe ...

Contract in place with a comprehensive kidney care provider serving more than 200,000 patients at its thousands of U.S. dialysis centers CAMBRIDGE, Mass., Oct. 22, 2024 /PRNewswire/ -- 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 has signed a multi-year commercial contract with one of the nation's leading providers of kidney care services, expanding access to Vafseo® (vadadustat) for ...

U.S. Renal Care is a leading provider of in-center and home dialysis in the United StatesCAMBRIDGE, Mass., Oct. 7, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, and U.S. Renal Care (USRC), the nation's fastest-growing dialysis provider, today announced entry into a multi-year commercial supply contract encompassing all USRC dialysis centers. The contract enables USRC attending physicians ...

Core Insights - Akebia Therapeutics and U.S. Renal Care are initiating a clinical trial for Vafseo to assess its impact on mortality and hospitalization in patients with chronic kidney disease [1][2] - The VOICE trial aims to enroll approximately 2,200 patients, comparing Vafseo to standard erythropoiesis-stimulating agents [2] - The trial's primary endpoint is all-cause mortality, while the secondary endpoint focuses on all-cause hospitalization, with a goal of demonstrating non-inferiority for mortality and superiority for hospitalization reduction [2][3] 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 [4] - U.S. Renal Care is the largest privately held dialysis provider in the U.S., serving over 36,000 patients across 32 states since its establishment in 2000 [5] Product Information - Vafseo (vadadustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoietin production to manage anemia in chronic kidney disease patients on dialysis [6][7] - Vafseo is approved for use in 37 countries and is indicated for adults receiving dialysis for at least three months [6][7] Clinical Trial Details - The VOICE trial will randomize patients to receive either oral Vafseo 300 mg three times per week or standard care agents, concluding approximately 18 months after the last patient is enrolled [2] - The trial is designed to provide real-world evidence regarding the safety and efficacy of Vafseo in alignment with patients' dialysis schedules [3]

Akebia Therapeutics (AKBA) has seen its share price rise after it gained FDA approval for Vafseo (vadadustat) tablets for the treatment of anemia due to chronic kidney disease (CKD) in late March this year.The approval of Vafseo tablets gave this Zacks Rank #2 (Buy) company its second FDA-approved product after Auryxia (ferric citrate), which is indicated for the control of serum phosphorus levels in adult patients with CKD on dialysis. The oral method of the use of Vafseo tablets makes it an easier-to-use ...

The Zacks Medical-Drugs industry is showing promising trends in 2024 amid strong M&A activity and positive pipeline news. Concerns around the economy and inflation, regular pipeline setbacks, uncertainty about the impact of Medicare drug price negotiations and the Federal Trade Commission’s (FTC) scrutiny of M&A deals are some of the headwinds faced by drug/biotech companies.However,innovation is at its peak for the industry, with key spaces like diabetes/obesity, inflammation and neuroscience attracting at ...

Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q2 2024 Earnings Conference Call August 8, 2024 8:00 AM ET Company Participants Mercedes Carrasco - Senior Director, Investor Relations John Butler - President and Chief Executive Officer Nicholas Grund - Senior Vice President, Chief Commercial Officer Erik Ostrowski - Senior Vice President, Chief Financial Officer and Chief Business Officer Conference Call Participants Julian Harrison - BTIG Ed Arce - H.C. Wainwright Operator Thank you for standing by. My name is And ...

Akebia Therapeutics (AKBA) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to loss of $0.06 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 33.33%. A quarter ago, it was expected that this kidney disease treatment developer would post a loss of $0.09 per share when it actually produced a loss of $0.09, delivering no surprise.Over the last four quarters, th ...