Akebia Therapeutics, Inc. Q4 FY2024 earnings call

• John Butler highlighted the progress in the Vafseo launch, with over 500 physicians prescribing Vafseo through the end of February and an average of about eight prescriptions each. The VOICE study in collaboration with U.S. Renal Care is enrolling over half of its target 2,200 patients. Plans for approval of Vafseo for the non-dialysis population were discussed, with a meeting with the FDA to discuss the VALOR study protocol planned.
• Nick Grund detailed the Vafseo launch, noting strong demand with over 70 peer-to-peer programs, broad attendance from dialysis clinic care teams, and over 500 physicians prescribing Vafseo. Reimbursement trends showed over 15% of prescriptions in February were for payers other than Medicare fee-for-service.
• Erik Ostrowski provided financial results, noting total revenues in the fourth quarter of 2024 were $46.5 million vs. $56.2 million in 2023, net loss of $22.8 million in Q4 2024 vs. net income of $0.6 million in Q4 2023, and cash and cash equivalents of $51.9 million as of December 31, 2024.

Auryxia was a key product segment. In the fourth quarter of 2024, Auryxia net product revenues were $44.4 million, down from $53.2 million in the fourth quarter of 2023. For the full year 2024, Auryxia net product revenues were $152.2 million, compared to $170.3 million in 2023. Vafseo, the new HIF-PH inhibitor, is in its launch phase. Akebia expects $10 million to $11 million in net product revenue for Vafseo in the first quarter of 2025, representing the early stage of its launch.

• Akebia does not plan to provide quarterly revenue guidance going forward but expects $10 million to $11 million in net product revenue for Vafseo in the first quarter of 2025.
• Expect to initiate the VALOR study in U.S. non-dialysis patients in the second half of 2024. A meeting with the FDA to discuss the VALOR study protocol is planned to potentially speed up the program.

• Market volatility in the early stages of the Vafseo launch. Challenges with specialty pharmacy capacity leading to backlogs for phosphate binders and Vafseo in the initial months of the year. Uncertainties related to regulatory approvals for the non-dialysis population and the success of contracting with Medicare Advantage plans for reimbursement.

Q: Does Q1 Vafseo revenue include any stocking or inventory build?

A: John Butler mentioned that the revenue guidance includes a bit of inventory as part of the initial launch.

Q: What are you seeing in terms of dose frequency, particularly for those in-center dialysis patients?

A: John Butler stated that almost all prescriptions are for the starting dose of 300 milligrams, and there are some smaller centers starting with TIW dosing but U.S. Renal has a QD dose protocol in place.

Q: How long until you think you see uptake at large scale dialysis orgs?

A: John Butler said large organizations have work to do in operationalizing protocols but are making the product available on a medical exception basis now, with experience building for the drug.

Q: I'm just wondering, if you could expand a little bit more on the Auryxia backlog. Has demand for Auryxia now with TDAPA Online maybe exceeded initial expectations?

A: John Butler explained the backlog was for all phosphate binders and Vafseo due to a shift to specialty pharmacy causing capacity issues, which has subsided but was initially a challenge.

Q: Could you talk a little bit more about the timing of your next regulatory interaction for initiating the VALOR study back half of this year?

A: John Butler said they are working to send a meeting request to the FDA for a Type C meeting to discuss the VALOR study protocol, with the goal of speeding up the program.

Q: You plan to disclose on a quarterly basis? And then a couple of follow-ups. First, on gross to net, what is that looking like right now in the early initial months? And where would you expect it to be steady state? And also the split between commercial and Medicare -- what is that looking like now? And then ultimately, where would you see it settling out steady state?

A: John Butler and Nick Grund discussed that gross to net isn't provided on the call but mentioned average prescriptions are for the starting dose, with WACC of $1,278 per bottle. Reimbursement shows over 15% of prescriptions are for Medicare Advantage, with commercial being a smaller portion of the dialysis population.

Q: What portions of the study design that you're seeking, can you share with us today? And do you think the cost of that study is embedded within your current run rate?

A: John Butler said the cost is embedded in the operating plan, and they aim to use a standard-of-care comparator and discuss analysis plans upfront with the FDA to make the trial efficient.