Yahoo Finance

Q & A Highlights

Q: Can you set some expectations for the upcoming Phase 3 in prurigo nodularis for Opzelura, given there's no topical therapies available? A: Pablo Cagnoni, President, Head of Research and Development, stated that the Phase 3 data for prurigo nodularis is expected in the first half of the year. The clinical bar is set based on Phase 2 data, focusing on improvements in global assessment of itching and WNRS endpoint. If the Phase 3 results are similar to Phase 2, Opzelura could be a significant addition for patients with prurigo nodularis.

Q: How did you arrive at the guidance for Opzelura's calendar year, and what are your expectations for the HS data? A: Christiana Stamoulis, CFO, explained that the guidance of $630 million to $670 million reflects 24% to 32% year-over-year growth, driven by demand in AD and vitiligo, potential pediatric AD launch, and increased European contribution. For HS data, Pablo Cagnoni emphasized the importance of statistical significance for HiSCR 50 at week 12, with expectations to replicate Phase 2 results for a competitive profile.

Q: What is the process for patients to benefit from the IRA out-of-pocket cap, and when will it impact sales? A: Christiana Stamoulis noted that the out-of-pocket cap is reduced to $2,000, with an option for equal payments throughout the year. The process may take time for patients to navigate, so immediate benefits may not be seen, but continued benefits are expected as in 2024.

Q: Are you seeking a label for biologic-naive patients in the Phase 3 trials for povo in HS, and how are the trials powered? A: Pablo Cagnoni confirmed that the trials stratify patients by prior biologic exposure, and data will be analyzed accordingly. The studies are powered based on assumptions around primary and key secondary endpoints, with labeling discussions to follow based on data.

Q: What are the expectations for the mutant-CALR and JAK2V617F proof-of-concept data, and what are the success criteria? A: Pablo Cagnoni expects substantive data at different dose levels for mutant-CALR, focusing on traditional endpoints and early evidence of allele reduction. For JAK2V617F, similar endpoints are anticipated, with updates expected later in the year.

Q: How will you disclose data from the STOP-HS1 and 2 Phase 3 trials for povo, and any updates on the X2 program for CSU? A: Pablo Cagnoni stated that data will be disclosed via press release and likely a call with the investment community. For the X2 program, updates will be provided later in the year as evaluations continue.

Q: What are the commercialization plans for ruxolitinib XR, and the timeline for a fixed-dose combination with the BET inhibitor? A: Herve Hoppenot, CEO, mentioned that ruxolitinib XR is expected to be commercialized in 2026, with a focus on transitioning patients to once-a-day dosing. The combination with the BET inhibitor depends on further data and portfolio evolution.

Q: Can you discuss the potential impact of upcoming competitor readouts on povo in HS, and how you view your value proposition? A: Pablo Cagnoni believes that povo has a competitive profile based on Phase 2 data, with strong efficacy and safety. The company is confident in its positioning against biologics and other competitors in the HS market.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.