Akebia Therapeutics, Inc. (AKBA) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights significant patient access expansion for Vafseo, improved financial performance, and positive physician feedback on clinical data. Although there are operational challenges, strategies are in place to address them. The Q&A reveals enthusiasm for the product and progress in partnerships, despite some uncertainties. Overall, the company's optimistic revenue growth expectations, patient access expansion, and improved net income suggest a positive stock price movement over the next two weeks.
Key Financial Performance
Total revenues $58.8 million this quarter, compared to $37.4 million in Q3 of last year, representing an increase of over $21 million. This increase was driven by sales of Vafseo and an increase in Auryxia sales.
Net product revenues $56.8 million this quarter, compared to $35.6 million in Q3 of last year. This increase was driven by Vafseo sales of $14.3 million and Auryxia sales of $42.5 million, compared to $35.6 million in Q3 of last year.
Cost of goods sold Decreased to $9.4 million this quarter, compared to $14.2 million in Q3 of last year. The decrease was primarily due to no longer recording a $9 million quarterly noncash amortization charge related to Auryxia's acquired developed product rights, which is now fully amortized.
R&D expenses Increased to $14.9 million this quarter, compared to $8.5 million in Q3 of last year. The increase was driven by higher clinical trial program activities, including the VOICE and VOCAL studies, and higher headcount-related costs.
SG&A expenses Increased to $29.1 million this quarter, compared to $26.5 million in Q3 of last year. The increase was primarily driven by higher marketing costs for the Vafseo U.S. launch and increased headcount-related expenses.
Net income Approximately $540,000 this quarter, compared to a net loss of $20 million in Q3 of last year. This improvement was driven by increased net product revenues, partially offset by higher operating expenses.
Cash position $166.4 million in cash and cash equivalents at the end of Q3. The company believes this is sufficient to fund its current operating plan to profitability.
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Operating Highlights
Vafseo launch progress: Generated $14.3 million in revenue this quarter, with more total prescriptions in the first 41 weeks than any recent dialysis launch. Expanded accessible patients from 40,000 to 70,000 by the end of Q3.
Clinical data for Vafseo: Presented data at ASN meeting showing lower risk of death or hospitalization compared to ESA control. Planning to publish new data to support clinical differentiation.
New dosing protocols: U.S. Renal Care implementing a 3 times weekly dosing protocol in Q1 2026, expected to improve adherence and compliance.
Market expansion for Vafseo: Expanded prescribing access to over 260,000 patients, including a successful DaVita pilot and rollout to all DaVita clinics, covering over 200,000 patients.
Auryxia sales: Increased to $42.5 million this quarter from $35.6 million in Q3 last year, despite losing IP exclusivity.
Operational challenges for Vafseo: Faced delays in aligning logistics and processes for home delivery and adherence issues in dialysis environments. Addressing these through retraining and protocol adjustments.
Cost management: Cost of goods sold decreased due to fully amortized Auryxia product rights and prelaunch inventory for Vafseo.
Pipeline advancements: VOICE and VOCAL studies underway to generate further data for Vafseo, with results expected in 2026 and 2027.
Profitability outlook: Achieved net income of $540,000 this quarter, driven by increased revenues and cost management. Existing cash resources are sufficient to fund operations to profitability.
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Risk or Challenges
Operational challenges in Vafseo launch: The company is facing delays in aligning logistics and processes for the new therapy, particularly for home delivery, which is a departure from traditional anemia treatment methods. This has impacted the speed of getting patients on therapy and maintaining adherence.
Lower-than-expected adherence rates: Adherence rates for Vafseo, particularly at USRC, are lower than expected, which is impacting growth. Efforts to improve adherence include retraining sales teams and adjusting protocols, but challenges remain.
Regulatory and protocol hurdles: Some dialysis organizations, such as DCI, have not yet enabled broad prescribing access through a protocol, delaying broader adoption of Vafseo.
Transition to new dosing regimens: The shift to three-times-weekly (TIW) dosing and the use of 300-milligram tablets for in-center use could impact inventory levels in Q4 and require operational adjustments.
Uncertain future Auryxia sales: Auryxia, which lost IP exclusivity in March, faces uncertainty due to potential additional generic competition, making future sales levels challenging to predict.
Increased operational costs: R&D and SG&A expenses have increased due to higher clinical trial activities, marketing costs for Vafseo's U.S. launch, and increased headcount-related expenses.
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Guidance & Outlook
Future clinical trial readouts: The VOICE study, adopting the Win-Odds endpoint, is expected to read out in early 2027. Additionally, the VOCAL study results, conducted at DaVita clinics, are anticipated in late 2026. These studies aim to provide critical data to support the long-term growth of Vafseo prescribing.
Label expansion and dosing protocols: Plans to engage with the FDA to add three-times-weekly (TIW) dosing to the Vafseo label. U.S. Renal Care (USRC) is implementing a TIW dosing protocol in their clinics, aiming for full availability by Q1 2026. This change is expected to improve patient adherence and compliance.
Market access and prescribing expansion: Prescribing access for Vafseo has increased to over 260,000 patients. DaVita has rolled out Vafseo to all its clinics, providing access to over 200,000 patients. IRC and other smaller providers are expected to drive broader adoption in Q1 2026.
Operational improvements and adherence: Efforts are underway to address operational challenges and improve patient adherence, particularly at USRC. Adjustments to protocols and retraining of sales teams are expected to enhance adherence rates and support growth.
Revenue and growth expectations: With expanded prescribing access and operational improvements, dialysis organizations are expected to increase ordering in Q4 2025, building momentum into 2026. The company aims to make Vafseo the standard of care for dialysis patients.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What strategies could be used to overcome operational challenges for Vafseo, including adherence issues and learnings from the DaVita pilot program?
A:The main strategy involves addressing adherence challenges, particularly during the first refill after the initial prescription. Patients often experience a hemoglobin dip, leading anemia managers to revert to ESA instead of titrating Vafseo. The company is focusing on educating sales teams and anemia managers about titration strategies and long-term use protocols. Learnings from the DaVita pilot program, such as improving clinical and reimbursement reviews and streamlining prescription processes, are being applied to other dialysis organizations. DaVita has rolled out Vafseo to its entire community of 200,000 patients, and the company is optimistic about improved adherence trends.
Q:What has been the physician feedback regarding the post-hoc analysis of vadadustat's impact on hospitalization outcomes?
A:Physicians were excited about the data, which showed a 1% lower mortality rate and an 8% lower hospitalization rate in the INNO2VATE study, though these were not statistically significant. Using a winds analysis, the data highlighted meaningful outcomes for patients. While the data cannot yet be used in the field until publication, it has generated enthusiasm among clinicians who believe in the product.
Q:What is the potential registrational path for acute kidney injury (AKI) and has there been communication with the agency?
A:There has been no communication with the agency yet as the AKI compound (AKB-9090) is expected to start Phase I trials early next year. However, the company is optimistic about clarity on the path forward due to its involvement in the Kidney Health Initiative and collaboration with the FDA and ASN.
Q:What are the greatest hurdles to expanding Vafseo to large dialysis organizations (LDOs) and medium dialysis organizations?
A:The main hurdles include gaining prescribing access, addressing operational challenges unique to each dialysis organization, and improving adherence. The company has made progress, such as DaVita making Vafseo available to 200,000 patients, but still faces challenges with Fresenius. Operational issues include understanding and navigating each organization's processes to facilitate easier patient access.
Q:What are the thoughts on Auryxia and the delay in generic market entry?
A:The company is surprised but pleased that generic approvals for Auryxia have not occurred yet, allowing them to continue providing the product to the market. They are uncertain about the reasons for the delay but are taking advantage of the situation during the TDAPA period for phosphate binders.
Q:How should new patient starts for Vafseo in DaVita and other organizations be compared to USRC?
A:New patient starts in DaVita and other organizations are expected to be more prescriber-driven compared to the push-driven approach at USRC. The company has learned from USRC's experience and expects a more gradual growth in patients as operational challenges are addressed.
Q:What is the current inventory situation for Vafseo and expectations for Q4?
A:USRC added about $1 million in inventory in Q3. As they transition to TIW dosing, they will work down their inventory of 150-mg tablets and require less inventory of 300-mg tablets. This transition may delay new patient starts in Q4 as physicians wait for the TIW protocol to be available.
Q:Review of Unclear Management Responses
A:Management avoided providing a direct answer regarding the potential registrational path for acute kidney injury (AKI), stating that it is too early for discussions with the agency. They also used vague language when discussing the reasons for the delay in generic approvals for Auryxia, stating they do not know why and are not inquiring further.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ASN
Conference
Dr
ESA
IRC
Odds analysis
TIW dosing
VOCAL study
Vafseo patient
Vafseo standard
Vafseo treatment
Win Odds
adherence
advocacy
care dialysis
center
control
discontinuation
dosing USRC
endpoint
factor
goal Vafseo
issue
launch dialysis
milligram tablet
organization prescribing
outcome
patient Vafseo
patient mid
patient therapy
patient today
pilot
prescribers Vafseo
prescribing access
refill
regimen
research
sentiment
start
success Vafseo
summary
time TIW
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Akebia Therapeutics, Inc. (AKBA) Q3 2025 Earnings Call Transcript
Positive11-10
The earnings call highlights significant patient access expansion for Vafseo, improved financial performance, and positive physician feedback on clinical data. Although there are operational challenges, strategies are in place to address them. The Q&A reveals enthusiasm for the product and progress in partnerships, despite some uncertainties. Overall, the company's optimistic revenue growth expectations, patient access expansion, and improved net income suggest a positive stock price movement over the next two weeks.
AKBA Report
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