Timur Ivannikov

Timur Ivannikov asked about the factors contributing to quarter-over-quarter variability in Empaveli's C3G launch momentum for 2026 and whether the company expects to provide start forms or other guidance again.

Answer

EVP of Commercial David Acheson explained that variability is typical for ultra-rare diseases, with the influx of patient start forms fluctuating weekly and monthly. He expressed confidence in the momentum from the launch. David Acheson confirmed that the company will continue to report on revenues but will not provide additional guidance on start forms beyond what was given for Q3 and Q4.

Timur Ivannikov inquired about the factors contributing to quarter-over-quarter variability in Empaveli's C3G launch momentum for 2026 and whether the company plans to provide start form updates or other guidance in the future.

Answer

EVP of Commercial David Acheson explained that variability is typical for an ultra-rare disease, with the influx of patient start forms fluctuating week-over-week and month-over-month. He expressed confidence in the momentum carried into 2026 from the previous year's launch. Acheson confirmed that the company will continue to report revenues and start forms but will not provide additional guidance on start forms beyond what was given for Q3 and Q4.

Timur Ivannikov, on for Steve Seedhouse at Cantor Fitzgerald, asked about the factors that led to higher Cyfovri revenue despite similar commercial doses quarter-over-quarter, and requested a breakdown of the 13,000 free injections between new patient samples and existing patient assistance.

Answer

EVP & Head of Global Commercial David Acheson explained that less than half of the growth was attributed to free goods/samples. He reiterated that demand is strong and growing, with patients starting on product through both commercial and free goods channels, including sampling and patient assistance programs.

Timur Ivannikov, for Steve Seedhouse at Cantor Fitzgerald, inquired about the factors that led to higher Cyfovri revenue despite similar commercial dose numbers quarter-over-quarter, and asked for a breakdown of the 13,000 free injections between new patient samples and existing patient assistance.

Answer

EVP of Commercial David Acheson clarified that a little less than half of the growth was attributable to free goods. He emphasized that overall demand is strong and growing quarter-over-quarter, with patient starts occurring through both commercial channels and the free goods programs.

Timur Ivannikov from Cantor Fitzgerald asked about the factors that led to higher Cyfovri revenue despite similar commercial doses quarter-over-quarter, and requested a breakdown of the 13,000 free injections between new patient samples and existing patient assistance.

Answer

EVP & Head of Global Commercial David Acheson stated that a little less than half of the growth was attributed to free goods/samples. He emphasized that there is true demand growth, with patients starting on product through both commercial channels and assistance programs, leading to the overall quarter-over-quarter growth.

Timur Ivannikov from Cantor Fitzgerald inquired about the factors that led to higher Cyfovri revenue despite similar commercial dose volumes quarter-over-quarter. He also asked for a breakdown of the 13,000 free injections between new patient samples and assistance for existing patients.

Answer

EVP of Commercial, David Acheson, attributed a little less than half of the growth to free goods and samples. He emphasized that underlying demand from physicians and patients is strong and continues to grow, with new patients starting on therapy through both commercial and patient assistance channels.

Timur Ivannikov asked about the necessity of a separate Phase III study for oral VK2735 in diabetes patients and inquired about FDA feedback regarding strategies to improve nausea rates, potentially through extended titration regimens.

Answer

Viking Therapeutics' President and CEO, Brian Lian, stated that while specific FDA communication details couldn't be disclosed, the company is comfortable with the Phase III transition. He indicated that the oral program's design would likely parallel the VANQUISH-1 and VANQUISH-2 overall design paradigm, with more details to be shared closer to launch.

Timur Ivannikov inquired about the necessity of a Phase 3 study for oral VK2735 in patients with diabetes and sought feedback from the FDA regarding strategies to improve nausea rates, potentially through extended titration regimens.

Answer

Brian Lian, President and CEO, indicated that specific design details for the oral VK2735 Phase 3 program would be disclosed closer to launch, but suggested it might mirror the VANQUISH-1 and VANQUISH-2 paradigm. He refrained from detailing FDA communications but expressed confidence in advancing to Phase 3.

Timur Ivannikov, on for Steve Seedhouse, asked about the Fragile X program, specifically inquiring about plans to enroll patients younger than 18 and if the company could quantify how much more CNS activity its molecule might achieve compared to competitors.

Answer

Chief Medical Officer Joanne M. Quan stated that the clinical plan is to start with adult patients and then step down in age, which is a typical approach. While she could not quantify the exact increase in CNS activity, she reiterated that MRM-3379's brain-to-plasma ratio is 'quite a bit higher' than the competitor's, which they believe is a significant differentiating advantage.

Timur Ivannikov from Raymond James questioned the primary gating factors for starting the randomized Phase 3 study, the data benchmarks required from the open-label portion, the cadence of future data releases, and sought clarification on the development plan and formulation for Amilo-5MER.

Answer

President and CEO Allen Baharaff explained that a strong efficacy signal from the open-label data is a key gating item to de-risk the program, and they may wait for data from more than the initial 50 patients if needed. He confirmed the next cohort's data is expected in Q2 2022. For Amilo-5MER, he clarified that the Phase 1a study was subcutaneous and that the company is now developing both an oral, locally-acting formulation for ulcerative colitis and an injectable formulation for other indications like RA.

Timur Ivannikov of Raymond James, on for Steve Seedhouse, asked about the primary gating factors for initiating the randomized Phase III study, the specific data benchmarks required from the open-label Aramchol data before proceeding, and the expected cadence of additional data cohorts from the open-label study.

Answer

Executive Allen Baharaff explained that the company must see a sufficiently strong signal from the open-label data to ensure a competitive product profile before launching the large, double-blind study, and they may wait for data from 100-150 patients if the first 50 is not enough. Chief Scientific Officer Liat Hayardeny noted the formulation development and data readout timelines are designed to intersect. Allen Baharaff confirmed the next data cohort, bringing the total to 100 patients, is expected in Q2 2022.

Timur Ivannikov of Raymond James sought clarification on whether the SHINE trial was considered underpowered, underdosed, or both, and if the company would consider another Phase II study. He also asked about the unblinding procedure and the reasons why 21 patients did not enter the open-label extension (OLE).

Answer

Executive Niels Riedemann stated the trial was underpowered to show a meaningful difference on the HiSCR endpoint with only 36 patients per group, given the score's high variability. He confirmed patients were not unblinded when transitioning to the OLE. He explained that the 21 patients who did not enter the OLE discontinued for a wide array of normal reasons, not a single common theme. The path forward, whether a Phase II or III trial, depends on regulatory feedback.