Ardelyx — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total product revenue for the quarter ended September 30, 2026, was $125.5 million, representing 19% year-over-year growth compared to $105.5 million in the prior year period.
• IBSRELA revenue reached $96.3 million, a 23% year-over-year increase.
• XPHOZAH revenue reached $29.2 million, a 7% year-over-year increase.
• Total revenues (including product supply and licensing) were $127.7 million for the quarter.
• Net loss for the quarter was $0.7 million, or $(0.00) per share, compared to a net loss of $1.0 million, or $(0.00) per share, in the prior year period.
• Research and development expenses were $25.2 million for the quarter, up from $18.1 million in the prior year, driven by investments in the ACCEL Phase 3 trial.
• Selling, general and administrative expenses were $93.9 million for the quarter, up from $83.6 million in the prior year, attributed to investments addressing access barriers and driving adoption.
• Cash, cash equivalents, and short-term investments totaled $285.3 million as of September 30, 2026, compared to $264.7 million as of December 31, 2025.
• Long-term debt increased to $252.4 million as of September 30, 2026, from $202.8 million as of December 31, 2025.
• Deferred revenue increased to $19.2 million as of September 30, 2026, from $14.9 million as of December 31, 2025.

Guidance and Future Outlook:

• Full-year 2026 revenue guidance for IBSRELA reiterated to be between $350 million and $370 million.
• Full-year 2026 revenue guidance for XPHOZAH reiterated to be between $110 million and $120 million.
• Full-year 2026 operating expense guidance reiterated to be below $500 million.
• Long-term guidance remains to achieve $1 billion in annual revenue for IBSRELA.
• Topline data for the Phase 3 ACCEL trial evaluating tenapanor for chronic idiopathic constipation (CIC) is expected in the second half of 2027.

Business Segments and Product Lines:

• IBSRELA growth was driven by increases in total writers and total prescriptions.
• XPHOZAH continues to generate revenue as an add-on therapy for adults with chronic kidney disease on dialysis.
• The Company completed enrollment ahead of schedule in the Phase 3 ACCEL clinical trial for CIC.
• Real-world data presented at the American College of Gastroenterology meeting showed reduced gastrointestinal-related healthcare resource utilization after adults with IBS-C started IBSRELA.
• Real-world data presented at the American Society of Nephrology Kidney meeting showed reductions in serum phosphate following XPHOZAH initiation in adults on dialysis.

Market and Competitive Landscape:

• The Company highlighted a robust tenapanor intellectual property portfolio as a key asset.
• The Company works with partners to develop and commercialize products outside of the United States.
• Forward-looking statements note risks related to competition, including from generic products.

Risks and Challenges:

• IBSRELA carries a risk of serious dehydration in pediatric patients and is contraindicated in patients under 6 years of age and those with known or suspected mechanical gastrointestinal obstruction.
• Diarrhea is a common adverse reaction for both IBSRELA (16% incidence) and XPHOZAH (43-53% incidence), with severe diarrhea reported in 2.5% of IBSRELA patients and 5% of XPHOZAH patients.
• Risks include coverage and reimbursement decisions by government and commercial payors, including prior authorization and step-edit requirements.
• Risks include the ability to successfully commercialize products, market acceptance, and the timing and results of clinical trials.
• Risks include the ability to obtain, maintain, and enforce intellectual property rights and reliance on third-party manufacturers.

Management Commentary and Tone:

• CEO Mike Raab stated that third-quarter results reflect the strength of the foundation built, with IBSRELA growth driving total product revenue over $125 million.
• Management expressed confidence in the value of IBSRELA strengthening due to the intellectual property portfolio and the fully enrolled Phase 3 ACCEL trial.
• Management cited a disciplined capital allocation strategy and a robust cash position as positioning the company to create and deliver significant long-term value.

Other Key Points:

• The U.S. Patent and Trademark Office notified the Company that U.S. Patent No. 12,788,750, titled "Oral Formulation of a Therapeutic Compound," will be issued on November 10, 2026, with an expiration date of December 6, 2041. This patent covers commercial formulations of both IBSRELA and XPHOZAH.
• The Company will host a conference call on November 3, 2026, at 4:30 PM Eastern Time to discuss the results.
• The Company has a next-generation NHE3 inhibitor, RDX10531, in its pipeline with potential application across multiple therapeutic areas.
• Share-based compensation expense included in the net loss for the quarter was $15.1 million.