Charles Wallace

Charles Wallace inquired whether the average discount on HEPZATO KIT pricing is expected to expand beyond the current 10% as more 340B eligible patients are added to the mix, or if the company still targets a 20% discount. He also asked if the 86% gross margin achieved in 2025 is expected to be maintained in 2026.

Answer

Gerard Michel, CEO, clarified that the specific 340B discount is 23.1%, but the effective average value per kit depends on the customer mix. He noted that the effective discount had fluctuated between 12% and 10%, with 10% being modeled for 2026, acknowledging the complexity of 340B eligibility. Sandra Pennell, CFO, guided for 2026 gross margins to be between 84% and 87%, dependent on quarterly sales and pricing impacts, and mentioned the potential to reach close to 90% in 2027 and beyond.

Charles Wallace asked if the 340B discount for HEPZATO KIT is expected to expand beyond the current 10% as more 340B eligible patients are added to the mix, or if the company is still targeting a 20% discount. He also inquired whether the 86% gross margin achieved in 2025 is expected to be maintained in 2026.

Answer

Gerard Michel, CEO, clarified that the direct 340B discount for eligible centers is 23.1%, but the effective average discount depends on the customer mix. He stated that Delcath Systems is modeling a 10% effective average discount for 2026, which is an improvement from Q3 2025 and closer to Q4 2025, acknowledging the complexity and variability of 340B eligibility. Sandra Pennell, CFO, guided for 2026 gross margins between 84% and 87%, noting that this is dependent on quarterly sales and pricing impacts, with potential to reach close to 90% in 2027 and beyond.

Charles Wallace asked for clarification on Mirum Pharmaceuticals' 2026 sales guidance, which implies 21%-25% annual growth compared to 55% in 2025, specifically inquiring about the relative contributions of LIVMARLI versus the bile acid portfolio to this projected growth.

Answer

CFO Eric Bjerkholt explained that the projected growth is primarily LIVMARLI-driven. He noted that 2025 revenues from Japan included a $22 million inventory buildup, which will result in lower comparative revenues from Japan in 2026 despite the launch progressing as expected. The bile acid portfolio is anticipated to contribute steady, but not accelerating, growth.

Charles Wallace questioned the 2026 sales guidance, which implies 21%-25% annual growth compared to 55% in 2025, seeking color on the drivers from LIVMARLI versus the bile acid portfolio.

Answer

CFO Eric Bjerkholt clarified that the growth is primarily LIVMARLI-driven. He noted that 2025 included $22 million in Japan revenues from inventory buildup, leading to lower expected Japan revenues in 2026, and anticipated steady, rather than accelerating, growth from the bile acid portfolio.

Charles Wallace from H.C. Wainwright asked about the upcoming two-year EVX-01 data presentation at ESMO, seeking details on how the clinical outcomes will compare to the one-year data and the number of patients involved in both the two-year data set and the three-year extension.

Answer

Birgitte Runa, Interim CEO and CSO, stated that the two-year data for EVX-01 has not yet been disclosed but confirmed that 11 patients remain active in the trial. She explained that the extension phase will involve a subset of these patients receiving EVX-01 as a monotherapy to better understand its standalone effect, with more details on patient numbers to be provided later.

Charles Wallace from HCW asked about the strategic rationale for increasing spending and delaying profitability at this time, and also questioned the contribution of Amazon sales to TRUVEGA handset revenue during the quarter.

Answer

CEO Daniel Goldberger explained that the timing for increased investment is ideal due to the recent sales force restructuring, promising results in the direct-to-consumer business, the integration of the Neurometrics acquisition, and the hiring of key talent like Kelly Benning and James Theophilus. Regarding Amazon, he stated that the company is still resolving logistical issues and did not have significant details to share on its sales contribution yet.

Charles Wallace of HCW requested more details on the planned 2026 interim analysis for the COM701 maintenance ovarian cancer study and asked if the trial is expected to be fully enrolled by that time.

Answer

Chief Medical Officer Dr. Michelle Mahler confirmed the study is expected to be fully enrolled by the 2026 interim analysis. She explained the analysis is designed to assess for futility and to help characterize the magnitude of COM701's effect size.