Akebia Therapeutics (AKBA) 2025 Conference June 05, 2025 08:45 AM ET Speaker0 Welcome to Jefferies twenty twenty five global healthcare conference. My name is Roger Song, one of the senior analysts cover Simica Biotech in The US. It's my pleasure to have the fireside chat with our first of the day company, Akebia Therapeutics. We have our CFO, CBO, Eric, and then Chief Commercial Officer, Nick here with us. Welcome gentlemen. Great. Thanks, Roger. Awesome. All right. Let's just kick this off and then we kno ...

Akebia continues to publish important, clinically relevant data to further physicians' understanding of Vafseo® (vadadustat) The vadadustat global phase 3 clinical trials were open-label, randomized, noninferiority trials that compared the safety and efficacy of vadadustat with darbepoetin alfa in adult patients with CKD-related anemia. Data from the pre-specified analyses for the U.S. patient subgroup demonstrate that among patients with DD-CKD, safety and efficacy of vadadustat and darbepoetin alfa in the ...

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. CAMBRIDGE, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted ...

Vadadustat clinical data on display for nephrologists and healthcare providersCAMBRIDGE, Mass., May 27, 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 it will present data at the 62nd European Renal Association (ERA) Congress on June 4-7, 2025, both virtually and live in Vienna. Akebia-supported presentations at ERA Congress 2025: A Win-Ratio Analysis of the Cardiovascu ...

Akebia Therapeutics (AKBA) FY 2025 Conference May 20, 2025 02:30 PM ET Speaker0 Right. So I guess we can get started here. So my name is Matthew Caulfield. I'm a senior biotech analyst here at H. C. Wainwright, and we're very excited to be welcoming Akebia Therapeutics. We're joined by John Butler, CEO, and also Nick Grund, chief commercial officer. So thank you very much for joining us today, guys. Speaker1 Thanks for having us, Matt. Great to you. Speaker0 So maybe to start off, you could maybe give us an ...

Akebia Therapeutics (AKBA) came out with quarterly earnings of $0.03 per share, beating the Zacks Consensus Estimate of a loss of $0.03 per share. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 200%. A quarter ago, it was expected that this kidney disease treatment developer would post a loss of $0.08 per share when it actually produced a loss of $0.10, delivering a surprise of -25%.Over the las ...

Akebia Therapeutics (AKBA) Q1 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Mercedes Carrasco - Senior Director of Investor & Corporate CommunicationsJohn Butler - CEO, President & DirectorNicholas Grund - SVP & COOErik Ostrowski - SVP, CFO & Chief Business OfficerNicholas Grund - SVP & COOLes Sulewski - VP - Biotech Equity Research Conference Call Participants Roanna Ruiz - Senior Managing Director, Biotechnology AnalystNone - AnalystRoger Song - Senior Equity Research AnalystAllison Bra ...

Financial Data and Key Metrics Changes - Total revenues increased to $57.3 million in Q1 2025 from $32.6 million in Q1 2024, driven by net product revenues of $55.8 million compared to $31 million in the prior year [22][25] - Net income for Q1 2025 was $6.1 million, a significant improvement from a net loss of $18 million in Q1 2024 [25] - Cost of goods sold decreased to $7.6 million in Q1 2025 from $11.6 million in Q1 2024, attributed to the absence of a non-cash amortization charge related to Auryxia [23][24] Business Line Data and Key Metrics Changes - Vafcio generated $12 million in net product revenues in Q1 2025, exceeding guidance of $10 million to $11 million [6][22] - Auryxia net product revenues increased to $43.8 million in Q1 2025 from $31 million in Q1 2024, despite the entry of an authorized generic [22][23] Market Data and Key Metrics Changes - The top five dialysis organizations have ordered Vafcio, with revenues primarily coming from small to mid-sized dialysis organizations treating approximately 150,000 patients collectively [7][14] - The VOICE study is progressing towards full enrollment, with about 75% of the target 2,200 subjects enrolled [9] Company Strategy and Development Direction - The company aims to expand the use of Vafcio in both dialysis and non-dialysis patient populations, with plans to initiate a Phase III VALOR trial in the second half of 2025 [10][11] - The focus remains on increasing the breadth and depth of prescribing among current customers while unlocking new customers [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong early performance of Vafcio, highlighting the importance of prescriber education and patient retention [6][7] - The company is confident in its financial position and believes it is financed to achieve profitability based on its current operating plan [25][26] Other Important Information - The company has at least 12 months of Vafcio inventory on hand in the U.S. and does not expect significant tariff-related impacts [24] - The average compliance rate in dialysis is expected to be around 65%, which will influence refill rates over time [60] Q&A Session Summary Question: Update on timelines for adding Vafcio to protocols at large dialysis organizations - Management indicated that a large pilot is planned to operationalize protocols, with training expected to take about a month before broader rollout [29][31][34] Question: Shift from Auryxia prescriptions to authorized generic - Management noted that the impact of the authorized generic has been minimal in Q1 2025, with expectations of maintaining significant revenue until more generics are approved [47][50] Question: Net price dynamics as large dialysis providers come on board - Management acknowledged the competitive environment and indicated that net price per patient is expected to decrease as volumes increase, with some lumpiness in pricing [55][57] Question: Demand drivers for Vafcio and reimbursement trends - Management highlighted that demand is driven by clinical value and economic incentives, with positive trends in Medicare Advantage coverage [70][78] Question: Inventory stocking trends with large dialysis organizations - Management expects initial stocking for pilots but does not anticipate significant issues with inventory levels due to efficient distribution networks [84][86] Question: Market landscape for label expansion opportunities - Management expressed excitement about the non-dialysis market, estimating a significant patient population and potential revenue opportunities [90][92]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Commission File Number 001-36352 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________to__________ AKEBIA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other juris ...

Akebia Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights Strong initial quarter of Vafseo® (vadadustat) U.S. product launch, with Vafseo net product revenues of $12.0 million in Q1 2025 Total Q1 2025 net product revenues of $55.8 million Bolstered balance sheet and expanded institutional investor ownership through $50 million underwritten public offering of common stock; cash and cash equivalents of $113.4 million as of the end of the quarter Exhibit 99.1 "We are treme ...