Funding from HealthCare Royalty Partners supports ongoing commercialization of IBSRELA® in the United States in exchange for future hyperphosphatemia royalty payments from Japanese collaboration partner Ardelyx
WALTHAM, Mass., June 30, 2022 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded to discover, develop and commercialize innovative first-in-class medicines , which addresses a significant unmet medical need, announced today that the Company has received up to $20 million from HealthCare Royalty Partners (HealthCare Royalty) from the sale of its future royalties and revenue milestones from Kyowa Kirin Co., Ltd (Kyowa Kirin), its collaborating partner in Japan, for the commercialization of Tenapanor in hyperphosphatemia.
“We have worked with HealthCare Royalty for many years and are looking for opportunities to work together. They have followed Kyowa Kirin’s progress in developing Tenapanor in Japan, and this funding further validates the value and potential of Tenapanor in treating patients with hyperphosphatemia,” said Mike Raab, President and Chief Executive Officer of Ardelyx. “Together with the development milestones that may be due under the license agreement with Kyowa Kirin and the payments that Ardelyx may be due under the recent amendment to the license agreement with Kyowa Kirin, we now have the opportunity to earn up to $85 million Dollars to receive basic capital based on Tenapanor’s potential for hyperphosphatemia in Japan.”
Under the terms of the agreement, Ardelyx will receive an upfront payment of US$10 million from HealthCare Royalty, an additional US$5 million upon receipt of regulatory approval from Kyowa Kirin to commercialize Tenapanor for hyperphosphatemia in Japan, and US$5 million for in the event that net sales in Japan exceed a certain target level by 2025. In return, HealthCare Royalty will receive the royalties and commercial sales milestones that Ardelyx is able to earn under the licensing agreement with Kyowa Kirin.
“The hyperphosphatemia market has lacked innovation for too long, and we believe that Tenapanor, as an innovative binderless therapy, has the potential to fill a significant unmet need in the treatment and control of hyperphosphatemia,” said Clarke Futch, Chairman and Head Executive Officer of HealthCare Royalty. “We are pleased to support Ardelyx’s efforts with its partner Kyowa Kirin in obtaining potential approval and commercialization of Tenapanor for hyperphosphatemia in Japan.”
On April 11, 2022, Ardelyx announced that it had changed its licensing agreement with Kyowa Kirin. Under the terms of the agreement, Kyowa Kirin agreed to pay Ardelyx consideration of up to US$40 million, payable in two tranches, with payment after the Kyowa Kirin’s submission to the Japanese Ministry of Health, Labor and Welfare (MHLW) of its Marketing Authorization Application for Tenapanor, which Kyowa Kirin has reported, is expected in the second half of 2022, and the second payment is due after Kyowa Kirin has granted approval for Kyowa Kirin to commercialize Tenapanor for hyperphosphatemia in Japan, which Kyowa Kirin has reported is currently expected in the second half of 2023.
The royalty rate at which Kyowa Kirin will make payments to Ardelyx on net sales under the amended license agreement was reduced from the high teens to the low double digits and then to the mid single digits for a two-year period. These royalties have now been sold to HealthCare Royalty along with certain sales milestones that Ardelyx may be due under the license agreement.
About Ardelyx, Inc.
Ardelyx was founded to discover, develop and commercialize innovative, first-in-class medicines that address significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (Tenapanor), is available in the United States. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphate in adult dialysis patients with chronic kidney disease, which has completed three successful Phase 3 studies. Ardelyx has a Phase 2 potassium secretagogue program, RDX013, for the potential treatment of elevated serum potassium or hyperkalemia, a problem in certain patients with kidney and/or heart disease, and an early-stage program in metabolic acidosis, a severe electrolyte imbalance in patients with CKD. Ardelyx has entered into agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada to develop and commercialize Tenapanor in their respective territories.
About HealthCare’s Royalty Partners
HealthCare Royalty earns royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HealthCare Royalty has $6.0 billion in cumulative committed capital with offices in Stamford (CT), San Francisco, Boston and London. Visit www.healthcareroyal.com for more information. HEALTHCARE ROYALTY PARTNERS® is a registered trademark of HealthCare Royalty Management, LLC in the United States and a trademark in other countries.
Forward-Looking Statements
To the extent that the statements contained in this press release are not descriptions of historical facts relating to Ardelyx, these are forward-looking statements that reflect management’s current beliefs and expectations made pursuant to the Safe Harbor of the Private Securities Reform Act of 1995, including the potential receipt by Ardelyx of up to a total of $85 million in development milestones from Kyowa Kirin; Payments by Kyowa Kirin under the recent amendment to the license agreement with Kyowa Kirin and the license agreement with HealthCare Royalty; Ardelyx’s expectations regarding the timing of Kyowa Kirin’s marketing approval application for Tenapanor for hyperphosphatemia in Japan; and Ardelyx’s expectations regarding the potential timing of Kyowa Kirin’s marketing approval in Japan. Such forward-looking statements involve significant risks and uncertainties that could cause Ardelyx’s future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, among other things, uncertainties related to drug development and regulatory processes in Japan. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks associated with Ardelyx’s business generally, please see Ardelyx’s Quarterly Report on Form 10-Q, which was filed with us by the Securities and Exchange Commission on May 5, 2022, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
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