RedHill Biopharma Ltd. Q4 FY2021 earnings call

• CEO Dror Ben-Asher thanked the team for achievements in 2021, noting record revenue in Q4 against the pandemic backdrop and R&D focus on COVID-19 and other therapies.
• CBO Guy Goldberg highlighted commercial success in Q4 with revenue from Talicia and Movantik, licensing deals with Kukbo and Gaelan Medical, and a cash position of $54.2 million as of December 2021.
• COO Gilead Raday discussed R&D programs: opaganib's dual action against COVID-19, RHB-107's promising efficacy in non-hospitalized COVID-19 patients, and RHB-204's advanced Phase 3 study for NTM infection.
• SVP Sales & Marketing Rob Jackson updated on commercial performance: Talicia and Movantik growth, market access success, and plans to expand the portfolio with synergistic products.
• CFO Micha Ben Chorin noted record net revenues, cash burn reduction, disciplined cost control, and ongoing licensing discussions for additional deals.

In the fourth quarter of 2021, RedHill achieved record revenue with commercial operations contributing positively for the first time. Talicia for H. pylori infection saw 132% growth over the previous year and became the most prescribed branded H. pylori therapy in December. Movantik for opioid-induced constipation had quarter-over-quarter growth and maintained market leadership in the PAMORA class. Net revenues for Q4 2021 were $22.1 million, and annual net revenues for 2021 reached a record $85.8 million. Talicia contributed to a 17% revenue growth between Q4 and Q3, while Movantik showed growth in prescription volume.

• Expect commercial operational profitability in 2022.
• Anticipate continued growth from organic sales of Talicia and Movantik, as well as non-organic growth through licensing and other business transactions.
• Confidence in achieving financial independence in the near future through organic and non-organic growth.

• The emergence of new COVID-19 variants (e.g., Omicron, BA.2) could impact the development and commercialization of COVID-19 therapies.
• Regulatory hurdles in obtaining approvals for R&D programs, such as for opaganib, RHB-107, and RHB-204.
• Dependence on successful licensing deals and market acceptance of commercial products, which could be affected by competitive landscape and payer coverage.

Q: Please characterize the size of the South Korea opportunity for opaganib and whether additional trials are needed there, and about business development for commercial assets.

A: Dror Ben-Asher noted they are looking at commercial assets synergistic to their existing basket, and Gilead Raday mentioned working collaboratively with partners in South Korea and adjusting approaches per territory.

Q: Regarding Talicia's revenue growth, cadence of growth, and RHB-204's NTM study endpoint.

A: Micha Ben Chorin noted 17% revenue growth in Talicia between Q4 and Q3, and Gilead Raday explained RHB-204's study expects primary endpoint at six months for potential accelerated approval with sputum culture conversion and patient reported outcomes as co-primaries.

Q: About opaganib's European market research, RHB-107's Phase 3 design, cholangiocarcinoma study, and R&D cost evolution.

A: Gilead Raday discussed global market research for opaganib, RHB-107's Phase 3 plans with FDA discussions, and Micha Ben Chorin mentioned targeting cost reduction in R&D for 2022 while expecting external funding for RHB-107's Phase 3 trial.