Ardelyx (ARDX) investor relations material

Commercial performance and product updates

• IBSRELA achieved $158 million in net sales last year, with 2024 guidance raised to $250–$260 million.

• XPHOZAH launched in late 2023, generating over $160 million in its first year.

• Both products address significant unmet needs with novel mechanisms, offering alternatives to existing therapies.

• Sales force expansions and targeted marketing have driven prescription growth for IBSRELA.

• Direct-to-patient strategies and omnichannel engagement are key to reaching the highly engaged patient population.

Market opportunity and growth outlook

• IBSRELA is positioned as a >$1 billion peak sales drug, supported by a large, growing market and high unmet need.

• XPHOZAH targets 220,000 CKD patients on dialysis, with 30–35% considered appropriate candidates.

• Peak sales guidance for XPHOZAH is $750 million, not including potential Medicare coverage.

• Market access investments and expanded sales teams are expected to sustain double-digit growth.

• Both products benefit from strong clinical profiles and differentiated mechanisms.

Regulatory and reimbursement environment

• Medicare Part D changes impacted XPHOZAH access, but the company implemented Ardelyx Assist to support patients.

• The ESRD payment bundle now includes oral phosphate binders, affecting distribution and reimbursement.

• Legal proceedings with CMS regarding XPHOZAH’s inclusion in the dialysis bundle are ongoing, with a key hearing on September 25.

• A favorable court ruling could reinstate Medicare Part D coverage, potentially accelerating growth.

• Current peak sales guidance for XPHOZAH excludes any Medicare benefit restoration.