Akebia Therapeutics, Inc. Q3 FY2025 earnings call

• At the American Society of Nephrology meeting, Vafseo's potential clinical benefit was highlighted, and data showed positive impacts on dialysis patients. - Through 41 weeks of launch, Vafseo had more total prescriptions than recent dialysis launches. Accessible patients increased from 40,000 in the first half of the year to almost 70,000 by the end of Q3. - The Win-Odds analysis from the INNO2VATE trial showed vadadustat had lower risk of death or hospitalization vs. darbepoetin alfa, with Dr. Block adopting this as the primary endpoint in the VOICE study, expected in early 2027, and VOCAL study results due late 2026. - USRC is implementing a TIW dosing protocol, aiming to have it in all clinics by Q1 2026, and shifting from 150-milligram to 300-milligram tablets for in-center use. - Operational challenges at USRC included lower-than-expected adherence, addressed by revamping messaging, retraining the sales team, and supporting protocol adjustments. More than half of surveyed nephrologists view Vafseo as providing more consistent anemia control with fewer dose adjustments.

Total revenues for Akebia's Third Quarter 2025 were $58.8 million, with net product revenues accounting for $56.8 million. Vafseo generated $14.3 million in revenue during the quarter. Auryxia sales reached $42.5 million in the third quarter, up from $35.6 million in the third quarter of the previous year. Cost of goods sold decreased to $9.4 million from $14.2 million in the third quarter of the prior year. R&D expenses increased to $14.9 million due to expanded clinical trial program activities, and SG&A expenses rose to $29.1 million primarily because of marketing costs related to the Vafseo U.S. launch and increased headcount-related expenses.

• Confidence in Vafseo becoming standard of care for dialysis patients. - Anticipation of VOICE study results in early 2027 and VOCAL study results in late 2026 as key data catalysts. - Expectation that TIW dosing implementation will improve patient adherence and drive long-term growth of Vafseo prescribing.

• Uncertainty regarding the timing of Auryxia generic approval. - Operational issues causing delays in patients accessing Vafseo therapy, including logistics and processes at dialysis providers.

Q: What strategies could be used to overcome operational challenges for Vafseo, including average adherence, and any learnings from the DaVita pilot?

A: Strategies around adherence include revamping messaging, retraining the sales team to educate on GI issues and dosing/titration strategies, and supporting protocol adjustments. Learnings from the DaVita pilot include working through kinks in prescription, reimbursement, and filling processes, and sharing these learnings broadly to impact adherence in other dialysis organizations.

Q: What has been physician feedback regarding the post-hoc analysis of vadadustat's impact on hospitalization outcomes?

A: Clinicians were extremely excited about the data from the post-hoc analysis, as it provides meaningful evidence for the product, though it needs to be published for medical teams to communicate in the field.

Q: What is the registrational path potentially like for the acute kidney injury indication?

A: AKB-9090, for acute kidney injury, is expected to start Phase I early next year, and it's too early to have conversations about the registrational path, but Steve Burke is working on it with relevant groups.

Q: What are the greatest hurdles to Vafseo expansion and thoughts on Auryxia?

A: Greatest hurdles are operational processes at dialysis providers, including working through logistics and protocols. For Auryxia, it continues to do well with no generic approval yet, but the generic is expected eventually, and the company will continue to provide product to the market.

Q: How should we think about new patient starts compared to USRC and inventory color?

A: USRC experience is prescriber-driven, different from other providers which are more prescriber-driven growth. In terms of inventory, USRC switching to 300-milligram tablets for in-center use may impact Q4 inventory, with Q3 inventory having added about $1 million, and new patients may be affected by waiting for TIW protocol availability.