Paris Soir - RedHill Announces Transformational Acquisition of Commercialization Rights to Ferring’s Rebyota® and Clenpiq®

The divestiture of Talicia and the acquisition of the new GI products from Ferring create a catalyst for commercial growth through a materially larger GI business under RedHill’s control, with a significantly stronger liquidity position and provides additional growth and expansion opportunities

Under the terms of the agreement, RedHill obtained the exclusive commercialization rights for an upfront payment to Ferring of $12 million plus potential future milestones and tiered royalties.

The $12 million upfront payment is fully funded through the previously announced $18 million Talicia divestment, with RedHill securing exclusive global and U.S. commercialization rights to Ferring’s Rebyota and Clenpiq, respectively - two synergistic, revenue-generating, FDA-approved GI drugs

Rebyota is a proprietary, first and only single-dose FDA-approved Fecal Microbiota Transplant (FMT for prevention of recurrent C. diff infection (rCDI). FDA-approved in 2022 and Health Canada-approved in 2025, Rebyota, was granted a Breakthrough Therapy and received Orphan Drug designations and generated approximately $16.9 million in 2025 U.S. net sales

Proprietary Clenpiq, a ready-to-use (no mixing required) low-volume bowel preparation on the U.S. market, generated $20.6 million in U.S. 2025 net sales with minimal promotion 

RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the transformational acquisition of exclusive global and U.S. commercialization rights to Rebyota and Clenpiq, from Ferring Pharmaceuticals (“Ferring”), as part of Ferring’s ongoing strategic refocusing.

Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “We have executed a clear strategic sequence. We have monetized Talicia for $18 million cash upfront, plus $35 million in potential upside, used $12 million to secure commercialization rights to two established, proprietary, FDA-approved gastrointestinal drugs, that collectively generated approximately $37.5 million in U.S. net sales in 2025, and emerged with a materially larger, fully controlled commercial business and a stronger liquidity position. Rebyota and Clenpiq are expected to generate a positive cash contribution to RedHill. This, combined with RedHill’s experienced and lean commercial team and proven development capabilities, creates a scalable foundation for further growth, including additional acquisition of complementary revenue-generating products.” Mr. Ben-Asher added: “We thank Ferring for a smooth process to date and look forward to a successful collaboration.”

Under the terms of the agreement, RedHill obtained an exclusive global commercialization license of Rebyota and an exclusive U.S. commercialization license of Clenpiq, for an upfront payment to Ferring of $12 million, plus tiered royalties on net sales and potential milestones. Ferring retains its Rebyota manufacturing facilities, and Ferring will continue to supply Rebyota through the term of the agreement.

“Rebyota is a first-in-class microbiota-based therapy for prevention of recurrent Clostridioides difficile (C. diff) infection (rCDI) in individuals 18 years of age and older following antibiotic treatment for rCDI. FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and an established customer base of approximately 600 active accounts,” said Rick Scruggs, RedHill’s Chief Commercial Officer. “Clenpiq, a ready-to-drink low-volume bowel preparation on the U.S. market, delivered $20.6 million in net sales in 2025, with minimal promotion. Together the two assets give RedHill a significantly stronger commercial growth engine in both the U.S. and other new territories.”

C. diff (CDI) infection is a distressing and life-threatening condition – in developed countries it is the most common cause of healthcare-associated (HA) diarrhea. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. 30,000 Americans die every year due to CDI, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings1. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences, indicating the need for use of prevention strategies.

Rebyota’s one-time administration, which requires no fasting, bowel prep or extended treatment timeframe, has demonstrated more than a 70% success rate at preventing rCDI. An aging population and accompanying increasing hospital-acquired vulnerabilities will likely increase this need. A streamlined ordering and reimbursement process is already in place for physicians, and broad and improving U.S. payer coverage means that 93% of lives have coverage including 43% with coverage after 1st recurrence.

Rebyota, which was granted, Breakthrough Therapy and Orphan Drug designations - with exclusivities and other patent protections that could run to 2036, provides multiple growth opportunities, including recent approval in Canada. The existing approvals also provide the potential for additional approvals in other territories.

Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually. This number is rising, with follow-up needed after noninvasive screening tests that yield a positive result, an aging population, and guidelines that recommend testing at age 45 instead of age 50, contributing to an increased need for colonoscopy. Bowel preparation is not a pleasant process and is often poorly performed.

Clenpiq is a ready-to-drink low-volume bowel prep. Clenpiq is readily available to patients and has broad commercial and government payer coverage: More than 108 million lives (63%) with unrestricted (no prior approval) have commercial coverage, including 57 million (33%) with preferred position. 23m lives (41%) of Medicare Part D lives have unrestricted access to Clenpiq, including 12m (21%) lives with preferred position5.

RedHill was advised by Morningstar Law Group and Greenberg Traurig LLP on this transaction.

About RedHill Biopharma  

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal therapies Rebyota, for the prevention of recurrent C. diff infection (rCDI), and the bowel preparation treatment, Clenpiq. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with a track record of U.S. government and academic collaborations intended for medical countermeasure development including for EVD, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.

More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the divestment of Talicia and the potential use of the proceeds of such sale; the expected benefits of the acquisition of commercialization rights to Rebyota and Clenpiq, the anticipated commercial growth and cash contribution from these products, expectations regarding market share growth, anticipated payer coverage, the Company’s strategic repositioning and path to operational profitability, potential use of milestone and royalty payments, and the Company’s ability to successfully commercialize Rebyota and Clenpiq. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. 

[i] Akorful RAA, Odoom A, Awere-Duodu A, Donkor ES. The Global Burden of Clostridioides difficile Infections, 2016-2024: A Systematic Review and Meta-Analysis. Infect Dis Rep. 2025 Apr 14;17(2):31. doi: 10.3390/idr17020031. PMID: 40277958; PMCID: PMC12026862.

[ii] Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, Farley MM, Holzbauer SM, Meek JI, Phipps EC, Wilson LE, Winston LG, Cohen JA, Limbago BM, Fridkin SK, Gerding DN, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913. PMID: 25714160; PMCID: PMC10966662.

[iii] Feuerstadt P, Theriault N, Tillotson G. The burden of CDI in the United States: a multifactorial challenge. BMC Infect Dis. 2023 Mar 7;23(1):132. doi: 10.1186/s12879-023-08096-0. PMID: 36882700; PMCID: PMC9990004.

[iv] Khanna S, Assi M, Lee C, et al. Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection. Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x.

[v] Data on file. Ferring Pharmaceuticals

[vi] MarketScan Commercial Claims and Encounters and Medicare Supplemental database

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T.Girard--PS