Julian Harrison

Julian Harrison asked about expectations for sequential Vafseo growth in 2026, considering Q4 2025 inventory-adjusted demand, the potential impact of the VOICE study on uptake, and the current operationalization of Vafseo access at DaVita, including the role of VOCAL data.

Answer

President, CEO, and Director John Butler explained that while Akebia is not providing revenue guidance, demand has been flat ($12M in Q2/Q3, $11M in Q4 2025), but growth is expected. He noted that nephrologists adopt products with measured growth and emphasized the importance of published clinical data (ASN, cost analysis, VOICE, VOCAL) for influencing utilization. Chief Commercial Officer Nicholas Grund added that DaVita has made Vafseo widely available, focusing initially on their home dialysis population and contemplating an observed dosing protocol. He highlighted that Akebia's field teams are crucial for physician education and increasing usage, noting early Q4/Q1 DaVita physician utilization. John Butler also mentioned the positive impact of observed dosing protocols on compliance.

Julian Harrison inquired about Akebia's expectations for sequential Vafseo growth in 2026, considering Q4 2025 inventory-adjusted demand. He also asked about the potential impact of VOICE study data on Vafseo uptake across dialysis providers and the current operationalization of Vafseo access at DaVita, including the role of VOCAL data.

Answer

CEO John Butler stated that Akebia is not providing revenue guidance but expects and is seeing growth from the Q4 2025 demand level of $11 million, following flat demand in Q2 and Q3. He emphasized that nephrologist adoption is measured, comparing it to past launches, and highlighted the importance of published clinical data (ASN, cost analysis, VOICE, VOCAL) for influencing utilization. Chief Commercial Officer Nicholas Grund detailed DaVita's Vafseo access, focusing on the home dialysis population and the contemplation of an observed dosing protocol. He noted that DaVita's approach relies on Akebia's field teams for education and sales, expecting steady, not 'hockey stick,' growth. John Butler added that observed dosing protocols, particularly three times weekly in-center, are expected to improve compliance and are receiving positive feedback from physicians and anemia managers.

Julian Harrison asked how the recently issued 299 patent contributes to Ardelyx's overall IP strategy for tenapanor, inquiring if it covers unexpected effects, and how potential CIC labeling could bolster ongoing efforts in IBS-C.

Answer

CEO Mike Raab clarified that the 299 patent is a formulation patent, Orange Book listed, expiring in 2042, and is part of a broader strategy to strengthen IP. He and Chief Commercial Officer Eric Foster explained that CIC approval would enhance physician confidence across both conditions due to their close relationship and shared screening, leading to increased adoption for both indications.

Julian Harrison from BTIG, LLC asked how the recently issued 2042 patent contributes to Ardelyx's overall IP strategy for tenapanor, inquiring if it covers unexpected effects or strengthens the patent. He also asked for expansion on how CIC labeling could potentially bolster ongoing efforts in IBS-C and the expected dynamics at play.

Answer

CEO Mike Raab confirmed the 2042 patent is a clear, Orange Book-listed formulation patent, crucial for strengthening the intellectual property bulwark for both products. He explained that CIC and IBS-C are closely related conditions, and an approved CIC indication would enhance physician confidence across both, leading to increased adoption and strengthening IBSRELA's position as a product of choice.

Julian Harrison of H.C. Wainwright & Co. inquired about the timeline for IND-enabling studies for the candidate under collaboration with Iovance and sought clarification on the status of out-licensing efforts for RXI-109 and Samcyprone.

Answer

Chief Development Officer Gerrit Dispersyn explained that the most direct path to the clinic is through investigator-initiated INDs with expert centers like CCIT. President and CEO Geert Cauwenbergh clarified that out-licensing efforts are ongoing, with due diligence underway with approximately a dozen companies for the dermatology and ophthalmology assets combined.