RDHL

Business Context and Reporting Period

This Form 6-K filing by Redhill Biopharma Ltd. (Nasdaq: RDHL) covers the month of February 2025, specifically dated February 25, 2025. The filing incorporates a press release announcing a strategic licensing agreement with Hyloris Pharmaceuticals SA. Redhill is a specialty biopharmaceutical company focused on gastrointestinal diseases, infectious diseases, and oncology, currently commercializing Talicia for H. pylori infection in the U.S.

Key Financial Metrics and Transaction Details

The filing details a significant commercial transaction but does not provide standard financial statements (revenue, profit, cash flow, or debt) for the period.

• Licensing Deal: Redhill licensed RHB-102 (Bekinda) to Hyloris for worldwide commercialization excluding North America (U.S., Canada, Mexico).
• Upfront Payment: An upfront payment was received, though the specific amount is not disclosed in the text.
• Milestone Payments: Up to $60 million in potential milestone payments contingent on commercial targets.
• Royalties: Up to mid-20s percent royalties on revenues, subject to cost recoupments and minimum annual payments.
• Market Context: The global antiemetics market was valued at approximately $7.5 billion in 2023, with an expected CAGR of 6% through 2030.

Material Changes and Pipeline Progress

The primary material change is the out-licensing of RHB-102 rights outside North America, shifting development and commercialization responsibilities for those territories to Hyloris. Redhill retains rights to develop and commercialize RHB-102 in the U.S. Key pipeline updates include:

• Regulatory Pathway: Received positive advice from the UK MHRA providing a clear pathway for a Marketing Authorization Application (MAA) for RHB-102 (24 mg) for chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV).
• Clinical Success: Published positive results from a U.S. Phase 2 study for IBS-D (12 mg) and a Phase 3 GUARD study for acute gastroenteritis (24 mg).
• Other Programs: Initiation of a Bayer-funded Phase 2 study for opaganib in advanced prostate cancer.

Outlook, Risks, and Management Commentary

Management views the agreement as validation of RHB-102's potential and a demonstration of the company's R&D pipeline strength. Redhill intends to pursue FDA approval for RHB-102 in the U.S. independently.

Risks and Contingencies:

• Uncertainty regarding the realization of milestone payments and royalties.
• Risk that the Company will not benefit from the agreement as anticipated.
• Dependence on U.S. government funding for certain development programs (e.g., opaganib).
• Regulatory risks, including the possibility that the FDA may not agree with proposed development plans or that clinical results may not be sufficient for approval.
• Competition and market acceptance risks for both RHB-102 and Talicia.

Investor Verification Checklist

• Verify the exact amount of the upfront payment received from Hyloris, as it is not specified in the filing.
• Confirm the specific terms of the "mid-20s percent" royalty rate and the structure of minimum annual payments.
• Monitor the timeline for the UK MAA submission and subsequent regulatory decisions.
• Review the status of U.S. government funding commitments for the opaganib program.
• Assess the company's cash runway and liquidity position in light of the upfront payment and ongoing R&D costs.