Earnings summaries and quarterly performance for Akebia Therapeutics.
Executive leadership at Akebia Therapeutics.
John P. Butler
Detailed
President and Chief Executive Officer
CEO
EJ
Erik J. Ostrowski
Detailed
Senior Vice President, Chief Financial Officer, Chief Business Officer and Treasurer
NP
Nicholas P. Grund
Detailed
Senior Vice President, Chief Commercial Officer
SK
Steven K. Burke
Detailed
Senior Vice President, Research & Development and Chief Medical Officer
Board of directors at Akebia Therapeutics.
Research analysts who have asked questions during Akebia Therapeutics earnings calls.
Allison Bratzel
Piper Sandler Companies
3 questions for AKBA
Also covers: ABCL, ALXO, ARDX +5 more
RS
Roger Song
Jefferies
2 questions for AKBA
Also covers: AADI, ALT, ALXO +13 more
AA
Antonio Arce
H.C. Wainwright & Co.
1 question for AKBA
Also covers: CLSD, CODX, ENTA
EA
Ed Arce
WestPark Capital
1 question for AKBA
Also covers: ABUS, ARCT, AUPH +5 more
LS
Leszek Sulewski
Truist Securities
1 question for AKBA
Also covers: AMRX, ANIP, BHC +6 more
Mazahir Alimohamed
Leerink Partners
1 question for AKBA
Also covers: AMRN, AQST, LNTH +2 more
RC
Roanna Clarissa Ruiz
Leerink Partners
1 question for AKBA
Also covers: AQST, ARDX, CRMD +5 more
Recent press releases and 8-K filings for AKBA.
Akebia Therapeutics Discusses Vafseo Launch and Pipeline Expansion
AKBA
Product Launch
New Projects/Investments
M&A
- Akebia Therapeutics is making progress with the Vafseo launch, expanding access to approximately 260,000 patients as of mid-November, following DaVita's rollout to its entire organization. Operational issues in dialysis centers are being addressed to streamline drug access.
- The company anticipates a potential drop in revenue in 2027 as Vafseo transitions from TDAPA to non-TDAPA pricing, with the price expected to decrease to levels comparable to ESAs (around $2,000-$2,500 per patient per year). This will be offset by increased volume from broader patient access post-TDAPA.
- Akebia has established a rare kidney disease pipeline, initiating a Phase 2 study for FSGS with praliciguat and acquiring AKB-097 (a complement inhibitor) for $7 million upfront plus future payments. Both products are expected to dose patients in 2026.
- The company also has earlier-stage HIF-based assets, including AKB-9090 for acute kidney injury, which will enter Phase 1 early next year, and AKB-10108 targeting complications of premature birth like retinopathy of prematurity.
- The FDA has indicated that a broader label for Vafseo in non-dialysis CKD would require a larger and longer study, which Akebia is not pursuing, but they are exploring subpopulations for potential future engagement with the FDA.
Dec 2, 2025, 9:30 PM
Akebia Therapeutics Provides Update on Vafseo Launch and Pipeline Expansion
AKBA
Product Launch
M&A
New Projects/Investments
- Akebia Therapeutics, a kidney disease company, provided an update on the launch of its second commercial product, Vafseo, which has expanded potential patient access to approximately 260,000 patients as of mid-November, following a full rollout by DaVita.
- The company anticipates a price decrease for Vafseo in 2027 post-TDAPA to ESA levels (~$2,000-$2,500 per patient per year) from its current WAC of approximately $15,500 per patient per year, with volume increases expected to offset this over time.
- Akebia has established a rare kidney disease pipeline, including praliciguat, which is initiating a Phase 2 study for FSGS with first patients expected in the new year, and AKB-097, a complement inhibitor acquired for $7 million upfront plus milestones, with Phase 2 studies for both expected to dose patients in 2026.
- The FDA indicated that a broad non-dialysis label for Vafseo would require a larger, longer study, leading Akebia to not pursue a broad label but to follow up on subpopulations.
Dec 2, 2025, 9:30 PM
Akebia Therapeutics Provides Vafseo Launch and Pipeline Updates
AKBA
Product Launch
New Projects/Investments
M&A
- Akebia Therapeutics, a commercial kidney disease company, is progressing with the Vafseo launch, which began this year in a billion-dollar market opportunity. Access has expanded to approximately 260,000 patients as of mid-November, including DaVita's full rollout, despite some operational challenges.
- The company anticipates a potential drop in Vafseo revenue in 2027 as it transitions from TDAPA to the dialysis bundle, with pricing expected to decrease to ESA levels (roughly $2,000-$2,500 per patient per year), though this will be offset by increased volume from broader patient access.
- Akebia established a rare kidney disease pipeline with two new assets: praliciguat, for which a Phase II study for FSGS is initiating, and AKB-097, a complement inhibitor acquired for an upfront payment of $7 million, with patients expected to be dosed in 2026 for both.
- Akebia will not pursue a broad label for Vafseo in non-dialysis CKD due to FDA feedback requiring a larger and longer study, but will explore opportunities in subpopulations.
Dec 2, 2025, 9:30 PM
Akebia Therapeutics Establishes Rare Kidney Disease Pipeline
AKBA
New Projects/Investments
M&A
- Akebia Therapeutics, Inc. announced the establishment of its rare kidney disease pipeline on December 1, 2025, which includes two core product candidates: AKB-097 and praliciguat.
- The company acquired global rights to AKB-097 from Q32 Bio Inc. for an upfront payment of $7.0 million and an additional $3.0 million due in six months.
- Akebia will also make potential milestone payments for AKB-097, including up to $94.5 million for development and regulatory milestones and up to $487.5 million for commercial milestones, plus tiered royalties on net sales.
- Phase 2 trials for both AKB-097 and praliciguat are planned to start treating subjects in 2026, with initial clinical data from the AKB-097 trial expected in 2027.
- The initiation of the praliciguat Phase 2 clinical trial triggers a $1.0 million regulatory milestone payment to Cyclerion Therapeutics, Inc..
Dec 1, 2025, 12:08 PM
Q32 Bio Sells Complement Inhibitor ADX-097 to Akebia Therapeutics
AKBA
M&A
New Projects/Investments
Guidance Update
- Q32 Bio sold its Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics.
- Q32 Bio will receive $12 million in upfront and near-term milestone payments, with potential for up to $592 million in total milestones and tiered royalties up to a mid-teen percent of annual net sales.
- This transaction is expected to extend Q32 Bio's cash runway into the second half of 2027 and allows the company to focus on advancing bempikibart for alopecia areata.
Dec 1, 2025, 12:00 PM
Akebia Therapeutics Amends Vafseo License Agreement with Medice
AKBA
New Projects/Investments
- On November 12, 2025, Akebia Therapeutics, Inc. and MEDICE Arzneimittel Putter GmbH & Co. KG (Medice) entered into Amendment #1 to their License Agreement.
- Under this amendment, Akebia Therapeutics will supply vadadustat drug substance to Medice.
- Medice has been granted the right to manufacture Vafseo tablets using the supplied drug substance.
- Akebia Therapeutics will retain ownership of any know-how or patent rights developed from Medice's manufacturing of Vafseo tablets.
Nov 17, 2025, 12:54 PM
Akebia Provides Vafseo Launch Update and Financial Outlook
AKBA
Product Launch
New Projects/Investments
Guidance Update
- Akebia's Vafseo launch is progressing, with DaVita opening product access to all its dialysis centers as of November 10. The company expects to increase patient access from 40,000 in the first half of the year to 260,000-275,000 by year-end, anticipating significant growth into 2026.
- U.S. Renal Care is transitioning to three times a week (TIW) dosing for Vafseo, which is expected to improve adherence and long-term business, though this transition and inventory adjustments may impact Q4 revenue.
- A win odds analysis of the INNO2VATE Phase 3 study demonstrated a statistically significant lower risk of dying or being hospitalized for patients treated with Vafseo compared to darbepoetin, supporting its potential as a standard of care.
- Akebia reported $166 million in cash as of the end of Q3 and has guided that it is financed to profitability, considering estimated revenues and pipeline expenses.
Nov 17, 2025, 12:00 PM
Akebia Provides Vafseo Launch Update, Financial Position, and Pipeline Outlook
AKBA
Product Launch
Guidance Update
New Projects/Investments
- Akebia's Vafseo launch for dialysis patients is progressing well, with patient access expected to grow from 40,000 to 260,000-275,000 by year-end 2025. DaVita opened Vafseo access to all its dialysis centers as of November 10, 2025.
- U.S. Renal Care, a major dialysis provider, is moving to three times a week (TIW) dosing for Vafseo, which is expected to improve patient adherence and is viewed as beneficial for long-term business, despite not being in the product's label.
- Akebia has a strong balance sheet with $166 million in cash as of the end of Q3 2025 and is financed to profitability, accounting for estimated revenues and pipeline advancement expenses.
- While the opportunity for Vafseo in the non-dialysis dependent (NDD) patient population faced a setback due to FDA feedback, Akebia plans to advance AKB-9090 for acute kidney injury into first-in-man studies early next year.
Nov 17, 2025, 12:00 PM
Akebia Provides Vafseo Launch Update and Financial Outlook
AKBA
Product Launch
Guidance Update
New Projects/Investments
- Akebia reported positive progress for its Vafseo launch in dialysis patients, noting significant access expansion from 40,000 to 260,000-275,000 dialysis patients by year-end, driven by adoption at U.S. Renal Care and DaVita.
- The company is addressing operational challenges and adherence issues by supporting three-times-a-week (TIW) dosing for Vafseo, which aligns with existing clinical practice and is supported by data.
- Akebia maintains a strong balance sheet with $166 million in cash as of the end of Q3 and has guided that it is financed to profitability, considering estimated revenues and pipeline expenses.
- The company plans to continue engaging the FDA regarding the non-dialysis dependent (NDD) patient population for Vafseo and is advancing its early-stage pipeline, including AKB 9090 for acute kidney injury.
Nov 17, 2025, 12:00 PM
Akebia Therapeutics Discusses Vafseo Commercial Progress and Financial Position
AKBA
Product Launch
Guidance Update
New Projects/Investments
- Akebia Therapeutics reported $14.3 million in revenue for Vafseo in the recent quarter, noting significant progress in market access, including DaVita expanding access to over 4,000 dialysis centers as of November 10th.
- The company emphasized the role of TDAPA (Transitional Drug Add-on Payment Adjustment) in allowing Vafseo to be sold at a higher price for two years, and views the anemia market as a billion-dollar opportunity in the U.S..
- Recent data presented at ASN demonstrated a statistically significantly lower risk of mortality or hospitalization with Vafseo compared to ESAs, with ongoing studies like VOICE expected to provide further differentiation.
- Akebia ended the quarter with $166 million on the balance sheet and has guided that it is financed to profitability, while also advancing its pipeline with AKB-9090 targeting acute kidney injury and AKB-10108 for retinopathy of prematurity.
Nov 10, 2025, 8:00 PM
Quarterly earnings call transcripts for Akebia Therapeutics.
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