Antonio Arce

Antonio Eduardo Arce of H.C. Wainwright & Co. inquired about the regulatory timeline for the Co-Dx PCR COVID-19 test resubmission, the clinical trial schedules for the TB and HPV tests in India and South Africa, and the anticipated pricing and gross margins for the new platform's instrument and test cups.

Answer

CEO Dwight Egan stated that the redesigned COVID-19 test is prepared for clinical evaluations, with the start date contingent on disease prevalence. He confirmed that clinical trials for the TB, HPV, and multiplex respiratory panels are all slated to commence in the second half of 2025, noting that ample sample availability for TB and HPV in India could potentially expedite those specific timelines. Egan projected a $300-$500 price for the instrument and $15-$20 per test in developed nations. CFO Brian Brown added that margins on the device and tests are expected to align with historical margins on previously sold equipment and lab-based tests, respectively.

Speaking for Yi Chen, Antonio Arce asked about potential FDA concerns with redosing a TKI within six months, the estimated cost of the Phase III wet AMD program, the scientific rationale for treating geographic atrophy as a choroidal disease, and the timeline for an IND submission for the GA program.

Answer

Chief Medical Officer Dr. Victor Chong stated the company has no concerns about the FDA's view on redosing, citing positive safety data from multiple doses in the Phase II study. CEO George Lasezkay said it is premature to discuss Phase III costs. Dr. Chong explained that GA is considered a choroidal disease because choroidal damage precedes RPE cell death, and it is too early to provide a specific IND timeline, though they are advancing toward a lead candidate.

Antonio Arce asked about Akebia's goal for dialysis center supply contract coverage by the January launch, given the current 60% level. He also inquired about the VOICE trial's timeline and its potential impact on prescribing. In a follow-up, he asked about the strategy to maintain Auryxia revenue amid upcoming generic competition, noting that all current contracts bundle both drugs.

Answer

Chief Commercial Officer Nick Grund stated the goal for Vafseo supply contracts is 100% coverage by launch, driven by favorable TDAPA reimbursement, a compelling pricing strategy, and strong clinical need. CEO John Butler explained the VOICE trial will enroll its first patient soon and is designed to generate outcomes data to drive utilization post-TDAPA, but is not required for regulatory approval. Regarding Auryxia, Butler positioned it as a key tool for enabling Vafseo contracts and expects to maintain revenue in 2025 due to limited initial generic entry and the value of a branded partner for dialysis organizations.

Asked about the success criteria for the EDP-323 challenge study in terms of AUC reduction, the rationale for testing two doses, and the timing and nature (small molecule) of the upcoming nonvirology program announcements.

Answer

The company aims for EDP-323's efficacy to be in the ballpark of EDP-938's strong challenge study results. The two-dose regimen test is to explore a potentially more cost-effective dosing strategy. They confirmed the new programs will be primarily small molecules and will be announced early in 2024.