RedHill Biopharma (RDHL) Corporate Presentation summary

Corporate highlights and financials

• Focuses on U.S. commercialization and development of drugs for GI, infectious diseases, and oncology, with a streamlined U.S. commercial organization and $2.6M net revenues in H1 2024.

• TaliciaⓇ is the leading branded U.S. prescription for H. pylori, supported by robust managed care coverage and government collaborations.

• Advanced clinical pipeline includes five late-stage assets, with multiple near-term milestones and significant de-risking via U.S. government partnerships.

• Market cap is approximately $7.2M, with $8.2M cash as of June 30, 2024, and a 45.4% gross margin in H1 2024.

• Senior leadership and board have extensive experience in pharma, biotech, and business development.

TaliciaⓇ: commercial product and clinical data

• Indicated for H. pylori infection in adults, TaliciaⓇ is FDA-approved and launched in the U.S. and UAE, listed as a first-line option in the 2024 ACG guideline.

• Demonstrated high eradication rates (>90% in adherent population) and zero to minimal resistance to its antibiotic components.

• Pivotal Phase 3 study showed 84% eradication (ITT) vs. 58% for comparator, with 90% in adherent population and favorable safety profile.

• Broad U.S. managed care coverage (200M lives), including Humana Medicare Part D, and a warranty program for efficacy.

• Market exclusivity through 2027 (QIDP designation) and patent protection to 2042; U.S. H. pylori therapy market estimated at $1.4B.

R&D pipeline: late-stage assets

• Opaganib: first-in-class, oral SPHK2 inhibitor with broad antiviral, anti-inflammatory, and anticancer potential; advanced in COVID-19, ARDS, GI-ARS, Ebola, and oncology, with multiple U.S. government collaborations.

• Opaganib showed significant mortality and recovery benefits in severe COVID-19 Phase 2/3 studies, potent antiviral activity against multiple viruses, and promising results in cholangiocarcinoma and prostate cancer.

• RHB-107: oral serine protease inhibitor for COVID-19, oncology, and GI; positive Phase 2 COVID-19 data with 100% reduction in hospitalization, included in U.S. government-supported PROTECT study.

• RHB-102 (BekindaⓇ): bimodal ondansetron for oncology support, gastroenteritis, and IBS-D; positive Phase 3 and 2 results, with UK MAA in planning.

• RHB-104: oral triple antibiotic for Crohn's disease; positive Phase 3 results with significant remission and response rates, robust patent protection, and plans for confirmatory studies in MAP-positive patients.

• RHB-204: fixed-dose oral therapy for pulmonary NTM disease; orphan and QIDP designations, but U.S. Phase 3 study terminated due to low accrual.