Ardelyx (ARDX) Piper Sandler 36th Annual Healthcare Conference summary

Company overview and recent performance

• Focus on novel oral small molecules addressing unmet medical needs, with two commercialized drugs: IBSRELA and XPHOZAH.

• Achieved nine consecutive quarters of revenue growth, with Q3 revenues of $40M for IBSRELA and $51M for XPHOZAH.

• Maintains a strong balance sheet with $240M in cash, supporting ongoing commercial and pipeline expansion.

• Leadership emphasizes commercial execution and is actively seeking complementary pipeline candidates.

XPHOZAH market access and regulatory challenges

• XPHOZAH is the first novel phosphorus-lowering agent in decades, facing upcoming CMS reimbursement changes as binders enter the bundle on January 1.

• Chose not to pursue TDAPA to preserve physician and patient decision-making, avoiding protocolization by dialysis organizations.

• Legislative efforts (Kidney Patient Act) and legal actions are ongoing to delay bundling, with optimism for a two-year extension.

• If legislative/legal avenues fail, a robust patient assistance program will ensure continued access, with costs flowing through SG&A.

• Commercial payers are not expected to restrict access, and 40% of the market remains commercially reimbursed.

Physician and patient perspectives

• Nephrologists express concern over new reimbursement dynamics, fearing reduced access to effective therapies.

• Company is committed to maintaining access for all patients, emphasizing the importance of meeting unmet needs.

• Strong support from patient advocacy groups and bipartisan congressional backing for legislative solutions.