Ardelyx (NasdaqGM:ARDX) Q4 2025 Earnings call February 19, 2026 04:30 PM ET Company ParticipantsAllison Arfstrom - Consumer Equity ResearchAydin Huseynov - Managing Director and Equity ResearchCaitlin Lowie - VP of Corporate Communications and Investor RelationsEric Foster - Chief Commercial OfficerJennifer Jia - Biotech Equity ResearchJulian Harrison - Managing DirectorLaura Chico - Managing Director and Equity ResearchLaura Williams - Chief Patient Officer and Interim Chief Medical OfficerMike Raab - CEOS ...

Financial Data and Key Metrics Changes - The company reported a significant year-over-year total revenue growth of 22%, with full-year 2025 revenues of $407.3 million, compared to $333.6 million in 2024 [32] - XPHOZAH revenues grew to $274.2 million, an increase of 73% compared to the full year of 2024 [33] - The net loss for 2025 was $61.6 million, or $0.26 per share, compared to a net loss of $39.1 million, or $0.17 per share, for 2024 [36] Business Line Data and Key Metrics Changes - IBSRELA achieved a remarkable revenue growth of 73% compared to 2024, with a 61% year-over-year growth in the fourth quarter [7][11] - XPHOZAH experienced a 9% increase in total dispenses and a 41% increase in paid dispenses when excluding Medicare compared to 2024 [18][34] Market Data and Key Metrics Changes - The IBS-C market continues to grow in double digits, with nearly 7 million prescriptions written in 2025, an increase of 11% compared to 2024 [13] - 77% of patients on a secretagogue report continuing to experience symptoms despite treatment, indicating a significant unmet need in the market [12] Company Strategy and Development Direction - The company aims to significantly grow IBSRELA and maintain XPHOZAH's momentum, with IBSRELA projected to deliver $1 billion in revenue by 2029 [10][39] - A new patent for the commercial formulations of IBSRELA and XPHOZAH, expiring in 2042, is part of the strategy to create valuable intellectual property [8] - The company is focused on expanding its pipeline with new development programs, including a phase III program for IBSRELA to include chronic idiopathic constipation (CIC) [9][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory and the ability to capitalize on opportunities ahead, emphasizing a patient-first strategy [10][19] - The company is positioned for long-term growth and value creation, with disciplined cash management and execution [9][32] Other Important Information - Research and development expenses for 2025 were $71.5 million, reflecting ongoing pediatric trials and the ACCEL trial for CIC [35] - The company finished 2025 with $264.7 million in total cash, an increase from $250.1 million at the end of 2024, and has generated positive cash flow for two consecutive quarters [37][42] Q&A Session Summary Question: Confidence in IBSRELA volume growth to reach $430 million guidance - Management expressed strong confidence in reaching the guidance, citing the large patient population needing alternatives to current treatments [46][47] Question: Cadence of expenses and path to sustained cash flow positivity - The company plans to increase operating expenses by 25% while expecting top-line growth of over 38%, indicating a disciplined approach to investments [55][56] Question: Details on the CIC trial and dose testing - The trial includes multiple doses to evaluate efficacy, with expectations that the middle dose will perform well based on previous data [65][66] Question: Distinctions in the CIC market compared to other treatments - Management highlighted the need for different mechanisms of action in treating CIC, emphasizing the potential utility of tenapanor [72][74] Question: Focus of prescribers in the phase III study for CIC - The primary endpoint will focus on achieving durable responses in bowel movements, with secondary endpoints including quality of life [79][81] Question: Future patent strategies and long-term growth for XPHOZAH - The company is actively working on strengthening its intellectual property position and is focused on ensuring patient access to XPHOZAH [87][88]

Financial Data and Key Metrics Changes - The company reported a significant year-over-year total revenue growth of 22%, with full-year 2025 revenues of $407.3 million, compared to $333.6 million in 2024 [30] - XPHOZAH revenues grew to $274.2 million, an increase of 73% compared to the full year of 2024 [31] - The net loss for 2025 was $61.6 million, or $0.26 per share, compared to a net loss of $39.1 million, or $0.17 per share, for 2024 [33] Business Line Data and Key Metrics Changes - IBSRELA achieved a remarkable revenue growth of 73% compared to 2024, with a 61% year-over-year growth in Q4 [5][11] - XPHOZAH saw total dispenses increase by 9% and paid dispenses by 41% when excluding Medicare compared to 2024 [18] - The IBS-C market grew by nearly 11% in 2025, with approximately 7 million prescriptions written [12] Market Data and Key Metrics Changes - The IBS-C market continues to grow double digits, indicating a robust demand for alternative treatments [12] - The company anticipates IBSRELA revenues for 2026 to be between $410 million and $430 million, representing at least 50% year-over-year growth [34] - XPHOZAH revenues are expected to be between $110 million and $120 million in 2026 [38] Company Strategy and Development Direction - The company aims to significantly grow IBSRELA and maintain XPHOZAH's momentum while advancing its pipeline of innovative medicines [9][41] - A new patent for IBSRELA and XPHOZAH was issued, expiring in 2042, which is part of the strategy to build a comprehensive intellectual property portfolio [6] - The company is focused on expanding its market presence through investments in prescriber engagement and patient education [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for IBSRELA, projecting it to reach $1 billion in revenue by 2029 [9] - The company is committed to patient access and has made bold decisions to ensure that all appropriate patients can access XPHOZAH [18] - Management highlighted the importance of disciplined cash management and execution, finishing 2025 in a stronger financial position than in 2024 [8] Other Important Information - The company has been cash flow positive for two consecutive quarters, with a total cash position of $264.7 million at the end of 2025 [34][40] - The company plans to invest approximately 25% more in operating expenses for 2026, focusing on R&D and commercial execution [39] Q&A Session Summary Question: Confidence in IBSRELA volume growth to meet guidance - Management expressed strong confidence in reaching the $430 million guidance, citing the vast patient population needing alternatives to current treatments [45][46] Question: Cadence of expenses and path to sustained cash flow positivity - Management indicated that while operating expenses will increase, they are growing at a slower rate than revenue, and they have been cash flow positive for the last two quarters [52][54] Question: Expectations for CIC trial dose levels - Management clarified that the lower doses in the CIC trial are part of a strategy to evaluate safety and efficacy, with a focus on finding the optimal dose [62][64] Question: Distinctions in the CIC market compared to other treatments - Management highlighted the need for different mechanisms of action in treating CIC, emphasizing the potential utility of tenapanor in this patient population [70][72] Question: Long-term growth for XPHOZAH post-2026 - Management noted that they do not benefit from Medicare base rate adjustments and are focused on ensuring patient access through Medicaid and commercial channels [87]

Summary of Ardelyx Conference Call Company Overview - Ardelyx, founded in 2007, focuses on developing small molecule drugs targeting the gastrointestinal (GI) lumen, specifically through NHE3 inhibition [5][6] - Key products include IBSRELA for Irritable Bowel Syndrome with Constipation (IBS-C) and XPHOZAH for hyperphosphatemia [6] Financial Performance and Guidance - Ardelyx raised its 2025 revenue guidance for IBSRELA to $270 million - $275 million, with a long-term goal of reaching $1 billion [6][18] - The company reported consistent quarter-over-quarter growth in demand for both IBSRELA and XPHOZAH [6][30] - XPHOZAH is contributing positively to the product P&L, despite challenges in the market [7][30] Market Dynamics - The IBS-C market is substantial, with over 6 million prescriptions written last year and double-digit growth over the past three years [15] - 77% of patients on current therapies (secretagogues) remain unsatisfied, indicating a significant opportunity for IBSRELA [12][13] - Ardelyx's sales force covers approximately 50% of the total TRX market, targeting around 14,000 physicians [10][22] Product Differentiation - IBSRELA is positioned as a unique therapy option, with 80% patient satisfaction compared to 77% dissatisfaction with secretagogues [13][12] - The company is focused on increasing awareness among physicians and patients to drive adoption of IBSRELA [22][24] XPHOZAH Challenges and Outlook - XPHOZAH faces challenges due to the TDAPA period affecting dialysis providers, but more patients have access to the drug than ever before [28][30] - The company expects a recovery in dynamics post-TDAPA period, which ends in early 2027 [32][34] - Long-term guidance for XPHOZAH is set at $750 million, with a target patient population of 60,000 [36] Pipeline and Future Developments - Ardelyx is advancing a new molecule (531) with greater potency and solubility, which may open new therapeutic opportunities [41][44] - The company plans to file an IND for the new molecule in the coming year [45] - Ardelyx is exploring potential in-licensing opportunities to enhance its pipeline [50][51] Financial Position - As of Q3, Ardelyx reported a cash balance of $242 million, with expectations for growth as the company approaches cash flow positivity [54] - The company is focused on maintaining a strong balance sheet while investing in future growth [54] Conclusion - Ardelyx is positioned for significant growth in 2026, with a strong focus on expanding its market presence and enhancing patient access to its products [56]

Core Insights - Ardelyx, Inc. reported Q3 2025 product revenue of $105.5 million, reflecting a 15% year-over-year growth, driven primarily by strong performance from IBSRELA and XPHOZAH [1][2][13] - IBSRELA revenue reached $78.2 million in Q3 2025, marking a 92% increase year-over-year and a 20% increase compared to Q2 2025, with full-year 2025 revenue guidance raised to between $270-275 million [1][4][13] - XPHOZAH generated $27.4 million in revenue during Q3 2025, up 9% from Q2 2025, supported by increased demand and effective commercial strategies [1][5][13] - The company announced the development of RDX10531, a next-generation NHE3 inhibitor, which is expected to have applications across multiple therapeutic areas [1][6][21] Financial Performance - Total revenue for Q3 2025 was $110.3 million, compared to $98.2 million in Q3 2024, primarily due to increased IBSRELA revenue, despite a decline in XPHOZAH revenue [13][28] - Research and development expenses for Q3 2025 were $18.1 million, up from $15.3 million in Q3 2024, while selling, general and administrative expenses increased to $83.6 million from $65.0 million [13][28] - The net loss for Q3 2025 was $1.0 million, or $(0.00) per share, compared to a net loss of $0.8 million, or $(0.00) per share, in Q3 2024 [13][28] Corporate Developments - Ardelyx appointed Sue Hohenleitner as Chief Financial Officer, effective November 4, 2025, and announced other key appointments in August 2025 [7] - The company had a significant presence at the 2025 Annual Scientific Meeting for the American College of Gastroenterology, showcasing its commitment to advancing medical knowledge and product visibility [8]