RedHill Biopharma (RDHL) Corporate Presentation summary

Corporate highlights and financials

• Focus on U.S. commercialization and development of drugs for GI, infectious diseases, and oncology, with $8.0M FY24 net revenues and a $4.8M cash balance as of December 2024.

• Streamlined U.S. commercial organization with a team of nine, six dedicated to commercialization, and a strong presence among gastroenterologists and primary care providers.

• Talicia is the leading branded U.S. prescription for H. pylori, with broad managed care coverage and rapid expansion in prescriber base.

• Multiple late-stage clinical assets, including five advanced clinical programs and significant U.S. government collaborations.

• Leadership team and board with extensive experience in pharma, R&D, and commercialization.

Talicia (omeprazole magnesium, amoxicillin, rifabutin) overview

• FDA-approved for H. pylori infection in adults, launched in the U.S. in 2020 and UAE in 2024, with UK approval targeted for Q4 2025.

• Demonstrates high eradication rates (>90% in adherent population) and favorable safety profile; all-in-one formulation supports adherence.

• Listed as first-line therapy in 2024 ACG guidelines and over 15 peer-reviewed publications; clarithromycin-free, addressing resistance concerns.

• Broad U.S. managed care coverage, including Medicare and Medicaid, with unique warranty and savings programs.

• Strong IP protection through 2042 and 8 years of market exclusivity via QIDP designation; not bioequivalent to generic triple therapy.

Talicia clinical data and market opportunity

• Pivotal Phase 3 studies showed 84–90% eradication rates vs. 58–65% for comparators, with no serious safety issues.

• Zero to negligible resistance for Talicia’s antibiotics, compared to high resistance for clarithromycin and metronidazole.

• U.S. H. pylori market estimated at $1.4B, global at $4.8B, with over 2M U.S. patients treated annually.

• H. pylori infection is a major risk factor for gastric cancer and affects over 50% of the global population.