Ardelyx Announces $20 Million Financing Agreement with HealthCare Royalty Partners
Ardelyx, Inc. announced it may receive up to $20 million from HealthCare Royalty Partners for future royalties from its collaboration with Kyowa Kirin on tenapanor for hyperphosphatemia. This financing validates the potential of tenapanor in Japan. Ardelyx will get $10 million upfront, $5 million post-regulatory approval, and another $5 million upon meeting sales targets. Overall, Ardelyx could gain $85 million in non-dilutive capital from Kyowa Kirin's development progress, despite reduced royalty rates from high teens to mid-single digits during the agreement period.
- Potential to receive up to $85 million in non-dilutive capital from Kyowa Kirin.
- HealthCare Royalty's investment validates tenapanor's market potential in Japan.
- Upfront payment of $10 million improves liquidity for Ardelyx.
- Royalty rates for Ardelyx were reduced from high teens to mid-single digits.
- Uncertainties in drug development and regulatory processes in Japan may affect revenue.
HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA® in the United States in exchange for future hyperphosphatemia royalty payments from Ardelyx Japanese collaboration partner
WALTHAM, Mass., June 30, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the company may receive up to
"We've been working with HealthCare Royalty for many years looking to find an opportunity for us to work together. They have been following the progress Kyowa Kirin has made in the development of tenapanor in Japan and this financing further validates the value and potential of tenapanor to treat patients with hyperphosphatemia," said Mike Raab, president and chief executive officer of Ardelyx. "Together with the development milestones that may become due under the license agreement with Kyowa Kirin and the payments that may become due to Ardelyx under the recent amendment to the license agreement with Kyowa Kirin, we now have the opportunity to receive up to
Under the terms of the agreement, Ardelyx will receive from HealthCare Royalty a
"There has been a dearth of innovation in the hyperphosphatemia market for too long and we believe tenapanor, as an innovative non-binder therapy, has the potential to address signficiant unmet needs in treating and controlling hyperphosphatemia," said Clarke Futch, chairman and chief executive officer of HealthCare Royalty. "We are pleased to support Ardelyx's efforts, with its partner Kyowa Kirin, in gaining potential approval and commercializing tenapanor for hyperphosphatemia in Japan."
On April 11, 2022, Ardelyx announced that it had amended its license agreement with Kyowa Kirin. Under the agreement, in consideration for a reduction in the royalty rate due to Ardelyx upon net sales in Japan, Kyowa Kirin agreed to pay Ardelyx consideration of up to
The royalty rate at which Kyowa Kirin will make payments on net sales to Ardelyx under the amended license agreement was reduced from the high teens to low double digits for a two-year period, and then to mid-single digits. These royalty payments, along with certain sales milestones that may become due to Ardelyx under the license agreement have now been sold to HealthCare Royalty.
Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet 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 to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium secretagogue program, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.
HealthCare Royalty purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HealthCare Royalty has
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential receipt by Ardelyx of up to an aggregate of
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