Keveyis

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Xeris Biopharma(XERS) - 2024 Q4 - Earnings Call Transcript
2025-03-06 15:52
Financial Data and Key Metrics Changes - Total revenue for 2024 was over $203 million, growing 24% year-over-year, driven by strong demand for Recorlev and Gvoke [8][14] - Net product revenue for Q4 2024 was $57 million, marking a 34% increase compared to the prior year [28] - Adjusted EBITDA turned positive in Q4 2024, with expectations to remain positive going forward [15][43] Business Line Data and Key Metrics Changes - Recorlev achieved $64.3 million in revenue for 2024, a 118% increase compared to 2023, with Q4 revenue of $22.6 million, up 131% year-over-year [9][28] - Gvoke generated nearly $83 million in revenue for 2024, a 24% increase, with Q4 revenue of $23.3 million, also a 25% increase [10][30] - Keveyis ended 2024 with approximately $50 million in revenue, a 13% decline year-over-year, but maintained a steady patient base [11][36] Market Data and Key Metrics Changes - The market for hypercortisolemia is expanding, with increasing diagnoses leading to more patients being treated [16][17] - Gvoke targets a large untapped market, with an estimated 14 million patients unprotected by life-saving therapies [18][19] Company Strategy and Development Direction - The company aims for total revenue between $255 million and $275 million in 2025, representing over 30% year-over-year growth at the midpoint [14][36] - Strategic priorities include driving growth of commercial products, maintaining financial discipline, and enhancing communication with stakeholders [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth, particularly for Recorlev and Gvoke, while anticipating steady demand for Keveyis [36][38] - The company is focused on leveraging its existing commercial capabilities for the development of XP-8121, a new product for hypothyroidism [25][102] Other Important Information - The company reported a gross margin of 84% in Q4 2024, a 1% improvement year-over-year, driven by a favorable product mix [32] - The company ended 2024 with a healthy cash position of $71.6 million [35] Q&A Session Summary Question: Recorlev strength and prescriber growth - Management noted both expansion of the writer base and increased prescriptions from existing prescribers contributing to Recorlev's growth [47] Question: Year-over-year prescription growth in hypercortisolism - Management indicated a lack of specific data on market growth but emphasized the importance of field efforts to identify patients [49] Question: Expectations for Keveyis in 2025 - Management suggested Keveyis may have found its bottom, with expectations to hold steady despite potential pressures on reimbursement [54] Question: Long-term spend to support Recorlev - Management acknowledged the need for continued investment in Recorlev, with a focus on expanding awareness and treatment [81][88] Question: Durability and exclusivity runway for Recorlev - Patents for Recorlev extend to 2040, with orphan exclusivity through 2028, providing a significant runway for growth [84][86] Question: Gvoke and updated guidelines - Management is focused on raising awareness of new guidelines to protect unprotected patients, viewing it as a long-term opportunity [94] Question: Phase 3 readiness for XP-8121 - Management confirmed plans for Phase 3 readiness, with potential clinical trials starting in 2026 [95]