ARDELYX, INC. Q3 FY2024 earnings call

• IBSRELA is delivering meaningful benefits to IBS-C patients, with demand growing and the sales team expansion completed. • XPHOZAH's launch is phenomenal, with a 39% QoQ net sales growth, addressing unmet medical need for dialysis patients. • Efforts to preserve XPHOZAH access include legal, legislative, and commercial strategies, such as partnering with coalitions, filing lawsuits, and not applying for TDAPA. • Justin discussed financials, noting revenue growth, expense management, and a strong cash position after amending debt with SLR Capital.

For IBSRELA, net sales were $40.6 million in the third quarter of 2024, showing a 15% increase quarter-over-quarter. For XPHOZAH, net sales revenue was $51.5 million in Q3 2024, a 39% quarter-over-quarter growth. IBSRELA saw continued strong demand with growth in new and refill prescriptions and new and repeat writers. XPHOZAH benefited from a large population of patients with unmanaged hyperphosphatemia, a nonbinder option, and receptive nephrologists.

• Narrowed full-year 2024 IBSRELA U.S. net product sales revenue guidance to between $145 million and $150 million. • XPHOZAH expected continued growth in the fourth quarter. • Drew $50 million and amended debt agreement with SLR Capital, resulting in a pro forma cash balance of over $240 million.

• Uncertainty around coverage for XPHOZAH for Medicare patients. • Potential negative impact on patient access to innovative therapies due to CMS's dialysis bundle policy. • Uncertainties related to court case outcomes and legislative progress regarding XPHOZAH coverage.

Q: What percent of XPHOZAH sales are not part of the Medicare bundle and how long to achieve $1B peak sales for IBSRELA?

A: Michael Raab said roughly 40% of XPHOZAH sales are non-Medicare bundle; timing for IBSRELA $1B peak sales is too early to specify yet as sales team expansion is new.

Q: Plans around education/outreach for XPHOZAH prescribers ahead of January 1?

A: Eric Foster said to continue messaging clinical benefits and access to therapy, keeping nephrologists at center of decision-making, with no differentiation between Medicare and non-Medicare populations.

Q: Progress on Kidney Care Act legislative front?

A: Michael Raab said there's progress with 38 co-sponsors in the house and 2 in the Senate companion bill, with coalition support.