RedHill Biopharma Ltd. Q2 FY2021 earnings call

• R&D Highlights: Opaganib showed strong inhibition of the Delta variant, was selected for the I-SPY COVID-19 clinical trial, and its global Phase 2/3 study in severe COVID-19 had the last patient out. The Phase 2 study of opaganib in prostate cancer met the primary endpoint. RHB-107 is in a Phase 2/3 study for non-hospitalized COVID-19 patients. RHB-204 is in a Phase 3 study for nontuberculous mycobacterial infection.
• Commercial Highlights: Achieved record quarterly revenues, Movantik volume grew 5.6% quarter-over-quarter, Talicia had over 10% growth, and there were market access wins for both Movantik and Talicia with major payors.

RedHill Biopharma reported record quarterly revenues despite the pandemic. The majority of revenues came from Movantik, which was approximately 90% of total revenues. Talicia showed over 10% quarter-over-quarter growth. Aemcolo was affected by reduced international travel due to COVID-19. Revenue contribution from Movantik was significant, with Talicia and Aemcolo also contributing to the top line.

• Anticipates top line results from opaganib's global Phase 2/3 study in hospitalized COVID patients soon. Expects commercial growth throughout the second half of the year. Aims to achieve commercial breakeven by the end of 2021.

• COVID-19 impact on enrollment for RHB-204 Phase 3 study, particularly in respiratory studies. Variability in the pandemic affecting clinical trial progress and commercial activities related to travel and patient access.

Q: About evaluating clinical data from Cosmo's Phase 2 study involving rifamycin in IBS-D patients, what's the status?

A: We are still evaluating the data together with our partners at Cosmo.

Q: Thoughts and expectations on opaganib inclusion in the I-SPY COVID trial and next steps if Phase 2/3 data is positive?

A: The I-SPY BARDA funded study is subject to FDA clearance. We'll announce Phase 2/3 data soon and then evaluate next steps based on the data.

Q: Comment on RHB-104 status and confirmatory Phase 3 trial plans?

A: A confirmatory Phase 3 study for RHB-104 is planned, with primary endpoint based on imaging, and it will involve regulatory discussions.

Q: Timing for opaganib Phase 2/3 data?

A: The data is upcoming, and we aim to announce it as soon as possible, likely before the end of September.

Q: RHB-204 Phase 3 enrollment timeline?

A: Enrollment has been slow due to COVID, but we expect it to pick up as COVID conditions improve.

Q: Breakdown of Movantik and Talicia revenues for the quarter?

A: The majority of revenues are from Movantik, with Talicia contributing additional revenues.