Ardelyx (ARDX) Business Update summary

Strategic update on patient access and regulatory developments

• Decision made not to apply for TDAPA for XPHOZAH to preserve patient access and maintain strategic flexibility in response to CMS's proposed 2025 PPS rule, which would bundle oral-only drugs and restrict access for all patients, regardless of insurance coverage.

• CMS's policy to include oral-only drugs in the ESRD bundle is viewed as anti-patient, likely to severely restrict access for both Medicare and non-Medicare dialysis patients.

• Legislative efforts are underway, with bipartisan bills in Congress aiming to delay the bundling of oral-only drugs until 2027, which is seen as the best path to preserve access.

• Historical precedents (e.g., KORSUVA, Parsabiv) show that similar policies led to restricted access and discontinuation of novel therapies.

• The company will continue to analyze options and communicate future strategies, including financial implications, as more information becomes available.

Clinical and market impact of XPHOZAH

• XPHOZAH, a first-in-class phosphate absorption inhibitor, is the only approved therapy for CKD patients on dialysis with inadequate response to phosphate binders, offering significant clinical benefit in lowering serum phosphorus.

• Uptake and patient outcomes since launch have been strong, reinforcing the importance of maintaining access.

• Approximately 80% of CKD patients on dialysis require prescription therapy to manage elevated serum phosphorus, and phosphate binders alone are often insufficient; about 70% fail to reach target phosphorus levels.

• The decision to avoid TDAPA is driven by the desire to prevent access erosion and ensure equitable treatment options.

• The field team remains focused on supporting nephrologists and patient needs during this period of regulatory uncertainty.

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.