RedHill Biopharma Ltd. Q3 FY2021 earnings call

• COVID - 19 Programs: Opaganib showed a 62% reduction in mortality in the global Phase 2/3 study among moderately severe hospitalized COVID - 19 patients, with expedited review granted by the EMA. The Phase 2/3 program of RHB - 107 in non - hospitalized patients in the U.S. and South Africa is progressing, with topline results expected in the first quarter of 2022. - Commercial: Talicia achieved record prescription volume growth, and Movantik continues to grow new prescriptions while maintaining market leadership. There have been significant market access successes for Movantik with key payers. - R&D: The Phase 3 study of RHB - 204 in pulmonary NTM disease continues enrolling patients. Progress with RHB - 104 for Crohn's disease is expected to accelerate due to recent progress in MAP detection research.

RedHill Biopharma reported net revenues of $21.6 million for the third quarter of 2021, marking the second consecutive quarter of record net revenues. Talicia saw a 15% growth in new prescriptions, while Movantik achieved a 1.1% increase in new prescriptions. Movantik maintains its market leadership in the PAMORA class. Revenue from Movantik was over $19 million and from Talicia was nearly $2.25 million in the quarter. Talicia performs well in the treatment of H. pylori infection, and Movantik benefits from its market position and positive payer coverage.

• RedHill is well - positioned to achieve commercial non - GAAP EBITDA breakeven before the end of the year. - For opaganib, the EMA is expected to provide preliminary feedback by the end of the year, and preliminary feedback from the U.S. FDA is expected in January 2022. - RHB - 107 is expected to provide topline results in the first quarter of 2022.

• The emergence of variants like Omicron poses a risk to the effectiveness of current treatments. - There are challenges in commercial promotion, such as the time required to build awareness and acceptance among payers and prescribers.

Q: Regarding the communication with regulators about the opaganib post - hoc analysis and the confirmatory trial plan, what's the situation?

A: Gilead Raday stated that everything discussed is subject to the regulatory feedback to be received, and the timing of the confirmatory trial is subject to regulatory feedback.

Q: What about the rebate situation and gross margin changes for Talicia?

A: Bob Gilkin said RedHill is within industry standards, and the clinical attributes of Talicia contribute to its good performance.

Q: About the reporting of efficacy data in the RHB - 107 Phase 2/3 study, what's the situation?

A: Dror mentioned that Part A of the RHB - 107 study mainly reports safety, and although efficacy endpoints will be captured, the small sample size in Part A won't provide clear efficacy conclusions but may get efficacy signals.

Q: What's the expected time for the opaganib confirmatory trial?

A: Gilead Raday indicated that based on the positive data from the study targeting the right patient population, the confirmatory trial is expected to be completed in under a year.