Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) invests $4 million in exchange for a 30% ownership stake and joint control in RedHill's Talicia business

U.S. co-commercialization partnership designed to accelerate Talicia sales growth, leveraging Cumberland's expanded national sales promotion and marketing support, and deliver significant efficiencies through shared operational responsibility

Transaction reinforces RedHill's financial position to advance its broader strategic objectives

Patent protected through 2042 and with eight years QIDP market exclusivity, Talicia is:
The #1 branded U.S. gastroenterologist-prescribed H. pylori therapy   Listed first-line H. pylori therapy in American College of Gastroenterology Clinical Guidelines ² The only FDA-approved all-in-one, low-dose rifabutin-based H. pylori therapy addressing antibiotic resistance

RedHill Biopharma Limited (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a strategic partnership with Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) ("Cumberland"), a specialty pharmaceuticals company with a strong gastrointestinal market presence, whereby Cumberland will invest $4 million for a 30% ownership stake in RedHill's global Talicia business. The companies will share in the financial performance and operational support for the Talicia brand with RedHill retaining 70% ownership and joint control. All other aspects of RedHill's business remain unchanged. 

RedHill and Cumberland have also entered into a U.S. Talicia co-commercialization agreement with an equal sharing of the product's net revenues. Cumberland commits to significant additional investment to support Talicia's U.S. business, providing the strength of its national sales force to feature and further enhance the brand's marketing and promotional activities. The partnership is designed to deliver economies of scale and cost reductions through shared responsibility for Talicia's U.S. sales, marketing, manufacturing, supply, regulatory and administrative operations.

"This strategic partnership provides an excellent growth opportunity for RedHill and for Cumberland, a highly capable and driven partner with a strong gastroenterology market presence, adding a market-leading approved product to its portfolio. We believe Cumberland can help drive prescriptions and deliver revenue growth, further strengthening Talicia's U.S. market leadership," said Dror Ben-Asher, RedHill's CEO. "The transaction highlights the significant standalone value and commercial strength of the Talicia business, and positions RedHill to accelerate growth, reinforce its financial position and reduce costs, while continuing to advance our broader strategic objectives."

"Talicia has an outstanding product profile and represents an excellent strategic fit for Cumberland, providing us with an important growth opportunity," saidA.J. Kazimi, Cumberland's CEO. "These arrangements with RedHill provide us with the only FDA-approved all-in-one, low-dose rifabutin-based therapy to address H. pylori antibiotic resistance in support of patient care. We can build on the excellent foundation RedHill has created for the product, representing a strong growth opportunity for both companies, and we are delighted to be working with them to pursue this potential."

"There is a real problem with H. pylori antibiotic resistance, with eradication treatment failure rates of up to 40% associated with clarithromycin-containing therapies³. Leading U.S. H. pylori treatment guidelines are explicit on the need to avoid using clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing," said Rick Scruggs, RedHill's Chief Commercial Officer. "Moreover, H. pylori is a key risk factor for gastric cancer, a cause of approximately 11,000 U.S. deaths⁴ a year. This is despite it being reported that eradication of H. pylori can lead to a 75% decreased gastric cancer risk.⁵ The need for effective H. pylori treatment designed to address antibiotic resistance is clear."

The transaction also supports RedHill's plan to regain compliance with Nasdaq's minimum stockholders' equity requirement and maintain its continued listing, supporting access to capital and long-term financial stability. Accordingly, as a result of this transaction, as of the date of this press release, the Company believes it has stockholder's equity in excess of the $2.5 million requirement for continued listing pursuant to Nasdaq Listing Rule 5550(b)(1). The Company intends to notify Nasdaq of its compliance status so that Nasdaq can make a determination as to whether the Company has regained compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. However, there can be no assurance that Nasdaq will determine that the Company has regained compliance with the Nasdaq continued listing standards.

RedHill is committed to expanding patient access to Talicia globally. This month we announced the licensing of Talicia for new Middle East markets in a deal worth potentially $1.8 million plus sales royalty payments, with efforts to further broaden market access and secure additional non-dilutive ex-U.S. licensing revenue streams ongoing.

Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.