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]