Ardelyx (NasdaqGM:ARDX) FY Conference Transcript

Summary of Ardelyx FY Conference Call - September 09, 2025 Company Overview - Company: Ardelyx, Inc. (Ticker: ARDX) - Industry: Biotechnology, focusing on gastrointestinal and kidney diseases Key Products - IBSRELA: Approved for irritable bowel syndrome with constipation (IBS-C) - Launched in Spring 2022 - Revenue: - $16 million in the first period - $80 million in 2023 - $158 million last year - Projected $250 million to $260 million in 2024 [3][4][8] - XPHOZAH: Approved for chronic kidney disease (CKD) with hyperphosphatemia - Launched in October 2023 - Revenue: Over $160 million in its first year [4][22] Market Opportunities - IBSRELA: - High unmet need: Only 25% of patients are fully satisfied with current therapies, leaving 75% open to new options [8][10] - Unique mechanism: NHE3 inhibition offers a different treatment option compared to existing therapies [5][16] - Growth potential: Expected to be a greater than $1 billion drug with sustainable double-digit growth [10][11] - XPHOZAH: - Market size: Approximately 220,000 CKD patients on dialysis, with 80% requiring pharmacological intervention [24] - Potential peak sales: Guided to $750 million, with 30% to 35% of patients being appropriate for therapy [24][25] Sales and Marketing Strategy - Increased sales force from 34 to 124 representatives to enhance market penetration [11][12] - Focus on direct-to-patient marketing to raise awareness of treatment options [15][33] - Ardelyx Assist program to facilitate patient access and affordability [32][33] Regulatory and Market Challenges - Impact of Medicare Part D changes on XPHOZAH uptake due to exclusion from coverage [22][23] - Ongoing legal proceedings regarding CMS's inclusion of XPHOZAH in the ESRD payment bundle, with a hearing scheduled for September 25 [37][38] Future Outlook - Continued focus on revenue growth from both products and potential new innovations from internal pipelines [42] - Monitoring of market dynamics and patient engagement to drive prescription growth [18][20] Additional Insights - The company emphasizes the importance of physician engagement and patient education in driving prescription rates [9][10] - The engaged patient population is seen as responsive to targeted marketing efforts [15][17]