Ardelyx (ARDX) Business Update summary

Strategic response to CMS policy changes

• Decision made not to apply for TDAPA for XPHOZAH to preserve patient access and maintain strategic flexibility in light of CMS's proposed 2025 rule, which is viewed as restricting access for all patients regardless of insurance coverage.

• XPHOZAH is being treated differently from phosphate binders, receiving standard TDAPA rather than the unique TDAPA for binders, resulting in less favorable reimbursement.

• The company is actively advocating for bipartisan legislation to extend the exclusion of oral-only drugs from the bundle, seeing this as the best path to maintain access.

• Ongoing analysis will determine future strategies, with updates promised once decisions are finalized.

• Management believes not applying for TDAPA provides the best flexibility to explore options for patient access amid regulatory uncertainties.

Impact on patient access and business outlook

• XPHOZAH has shown significant clinical benefit in lowering serum phosphorus for dialysis patients, with strong uptake and positive feedback from the field.

• XPHOZAH is the only approved therapy for CKD patients on dialysis with inadequate response to phosphate binders, offering a first-in-class mechanism to reduce serum phosphorus.

• The decision to avoid TDAPA is intended to protect access for both Medicare and non-Medicare patients and to allow time for legislative or alternative solutions.

• No immediate impact on 2024 sales is anticipated, with continued strong enthusiasm and uptake expected.

• Eighty percent of CKD patients on dialysis require prescription therapy to manage elevated serum phosphorus, and phosphate binders alone are often insufficient.

Safety and usage information

• XPHOZAH is taken as a single tablet twice daily; diarrhea is the most common side effect, occurring in 43-53% of patients, mostly mild-to-moderate and resolving over time or with dose reduction.

• Severe diarrhea was reported in 5% of patients; XPHOZAH is contraindicated in pediatric patients under 6 and those with mechanical GI obstruction.