Vafseo Dialysis Access Expands with DaVita Pilot

Akebia Therapeutics (AKBA) Second Quarter 2025 Earnings Call: Key Takeaways

Management View

• John P. Butler, the Chief Executive Officer, announced that “we earned more than $13 million from Vafseo sales in the second quarter, driven by roughly $12 million in demand sales, which represents a 55% jump from the first quarter.” Butler emphasized the upcoming expansion of Vafseo availability, noting that “starting in September, we anticipate that doctors within these dialysis networks will be able to prescribe Vafseo freely, increasing the total number of patients with access to over 75,000.” He also disclosed that DaVita is planning a Vafseo operational trial, with initial orders already made and patients expected to begin receiving the medication by mid-August, setting the stage for access to “a minimum of 275,000 patients later in the fourth quarter.”
• Butler also shared that the VOICE trial has reached its full participant capacity, exceeding 2,100 patients. Additionally, he announced the launch of the VOCAL study within DaVita centers, aiming to enroll 350 patients to analyze the properties of red blood cells.
• Concerning the broadening of the label, Butler mentioned that they “completed a Type B meeting with the FDA in May” and are intending to use an “active ESA comparator” in the future VALOR study involving chronic kidney disease patients who are not on dialysis.
• CFO Erik John Ostrowski reported, “This quarter’s total revenue reached $62.5 million, a jump of $18.9 million from the $43.6 million recorded in the second quarter of the previous year.” Ostrowski continued, “Our net income for the quarter was $247,000, a significant turnaround from the $8.6 million net loss in Q2 last year.” He also pointed out a drop in the cost of goods sold to $9.9 million and highlighted a cash and cash equivalents balance of $137.3 million at the close of Q2, asserting, “We are confident that our current cash reserves, along with anticipated cash flow, will adequately support our operational strategy until we achieve profitability.”

Outlook

• The management team anticipates that the number of patients with access to Vafseo prescriptions will rise from around 40,000 to more than 75,000 during the third quarter. They also project that the DaVita pilot program will provide access to over 275,000 patients in the fourth quarter.
• The VOICE research project is expected to wrap up towards the end of 2026, with the data ready for analysis in early 2027. Meanwhile, the VALOR study, aimed at individuals with chronic kidney disease who are not on dialysis, is scheduled to begin before the year concludes.
• Butler announced, “Our aim is to launch VALOR before the year concludes.”

Financial Results

• The company’s overall income reached $62.5 million, with $60.5 million stemming from net product sales, primarily due to Vafseo and Auryxia.
• Vafseo generated $13.3 million in sales, and Auryxia’s sales totaled $47.2 million. The cost of goods sold decreased to $9.9 million, but research and development expenditures rose to $11 million, primarily due to Vafseo’s clinical studies.
• The company generated a net income of $247,000, a significant improvement from the $8.6 million net loss reported during the equivalent period of the previous year.
• Ostrowski clarified that the quarter’s net income growth stemmed from higher revenues, though this was partly diminished by $5.4 million in interest costs, along with a $7 million non-cash expense due to fluctuations in the fair value of their warrant liability.

Q&A

• Roger Song from Jefferies inquired about how the types of patients and the distribution of payments might change as access widens and DaVita begins using the service. Nicholas Grund answered that “home patients…account for roughly 12% of all prescriptions, with the rest going to patients receiving treatment at centers.” He also anticipates “continued widespread adoption” as DaVita and other providers start utilizing the service. Grund pointed out that “approximately 20% of all prescriptions are for patients in the Medicare Advantage segment…while 80% are for those with traditional Medicare,” but he added that this breakdown is evolving as new agreements are put in place.
• Song asked what the typical dosage was. Grund responded, “We’ve noticed that repeat prescriptions are roughly 28% higher than the initial 300-milligram dose.”
• Julian Reed Harrison, BTIG: Asked about DaVita’s pilot timeline and protocol implementation at other large dialysis organizations. Butler said, “the DaVita operational pilot…will last 3 months,” with network-wide access expected by “the middle of November.” Regarding Fresenius, Butler stated, “We have not been able to progress yet…they would probably do a similar kind of operational pilot before they get broad access.”
• Harrison inquired about the schedule for the VALOR study. Butler responded, “The previously mentioned figure of a 1,500-participant study hinges entirely on the speed of our enrollment process.”
• Mazahir Lukman Alimohamed, Leerink Partners: Asked about Auryxia’s resilience and generic competition. Grund explained that increased access post-bundle is driving Auryxia’s use. Ostrowski noted, “new generic competition could come up at any time. So we budget conservatively.”

Sentiment Analysis

• Analysts were generally positive, focusing on launch metrics, access expansion, and market segmentation, but pressed for details on payer mix, dose trends, and competitive dynamics.
• Management maintained a confident tone in prepared remarks and Q&A, frequently citing strong progress and growth. Butler stated, “we’re happy with the progress on growing breadth and depth of prescribing, increasing patient access and physician education.”
• Compared to the previous quarter, both analyst and management tone showed increased optimism, with analysts more focused on access expansion and management providing concrete timelines and growth metrics.

Quarter-over-Quarter Comparison

• Guidance language sharpened to specify timelines and patient access milestones, shifting from anticipation of LDO pilots to confirmation of DaVita’s operational pilot and broader access.
• Strategic focus evolved from early-stage launch to scaling access and execution of pivotal trials (VOICE fully enrolled, VOCAL initiated, VALOR planning advanced).
• Analysts’ focus moved from initial launch and reimbursement to specifics of patient mix, dosing, and market share as large providers onboard.
• Key financials improved, with total revenues and profitability higher than Q1, and cash resources strengthening.
• Management’s confidence increased, supported by tangible sales growth and expanded prescribing access.

Risks and Concerns

• Management identified uncertainty regarding future Auryxia sales due to potential additional generic competition. Ostrowski cautioned, “future Auryxia sales levels are challenging to predict due to the uncertainty around the timing of potential additional generic competition.”
• The company noted that Vafseo sales in the quarter were derived from prelaunch inventory, which may not reflect ongoing manufacturing costs.
• Analysts raised questions about payer mix evolution and coverage for Vafseo, as well as competition dynamics for Auryxia.

Final Takeaway

Akebia Therapeutics emphasized accelerating Vafseo’s expansion in the dialysis market, with prescribing access expected to more than triple in the coming quarters as DaVita’s pilot concludes and other large providers come online. Strong revenue growth, successful trial progress, and a solid cash position underpin management’s confidence in advancing Vafseo toward standard of care status and pursuing label expansion, while remaining vigilant regarding generic competition for Auryxia and evolving reimbursement landscapes.

Read the full Earnings Call Transcript