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Xeris Biopharma Holdings (NasdaqGS:XERS) FY Conference Transcript
2025-12-02 18:32
Summary of Xeris Biopharma Holdings FY Conference Call Company Overview - **Company**: Xeris Biopharma Holdings (NasdaqGS:XERS) - **Industry**: Biopharmaceuticals - **Products**: Gvoke HypoPen, Keveyus, Recorlev - **Growth**: The company has raised its revenue guidance to $285 million-$290 million, reflecting a 42% growth at the midpoint [2][3] Core Insights Financial Performance - **Gross Margins**: The company reports 85% gross margins, which are improving [2] - **EBITDA**: Adjusted EBITDA became positive a year ago, with net income reported for the first time last quarter [3] Product Focus: Recorlev - **Market Awareness**: Increased screening for hypercortisolism among endocrinologists is driving Recorlev's growth, particularly in patients with uncontrolled type 2 diabetes and hypertension [4][5] - **Patient Demographics**: Patients treated with Recorlev have hypercortisolemia, with cortisol levels 1.8 times or higher than normal, often accompanied by conditions like diabetes or obesity [6] - **Sales Force Expansion**: The sales force was increased by 50% in August 2024 and is set to double by January 2026, targeting 12,000 physicians [10][11] - **Payer Access**: The focus is on demonstrating medical necessity for patients with hypercortisolemia to facilitate access [16] - **Competitive Landscape**: The entry of Corcept's relacorilant is seen as beneficial for overall market awareness, with no expected disruption to Recorlev's sales [18][20] Product Focus: Gvoke - **Market Penetration**: Gvoke is primarily used in type 1 diabetes, with efforts ongoing to increase awareness among clinicians regarding its necessity for patients on insulin or sulfonylurea [26][30] - **Payer Access**: Over 80% access is reported, with the main challenge being clinician awareness rather than payer issues [33] - **Competitive Dynamics**: The market can accommodate both Gvoke and Baqsimi without significant competitive disruption [36] Product Focus: Keveyus - **Market Position**: Despite generic competition, Keveyus maintains steady sales around $11 million per quarter due to comprehensive patient support services [41] Pipeline Product: XP-8121 - **Market Opportunity**: Targeting 3-5 million patients who cannot achieve normal thyroid levels due to GI absorption issues, with a projected market opportunity of $1 billion-$3 billion [43][49] - **Phase 3 Trial**: A phase 3 trial is planned for late 2026, aiming to establish therapeutic equivalence to daily oral levothyroxine [50] Additional Insights - **Intellectual Property**: Xeris holds multiple patents for Recorlev, with protections extending to 2040, which strengthens its market position against generics [22][23] - **Acquisition Strategy**: The company is open to acquiring assets that can leverage its existing commercial infrastructure, targeting $750 million in revenue by 2030 [54] Conclusion Xeris Biopharma is positioned for significant growth driven by its key products, particularly Recorlev, with a strong focus on expanding its market presence and enhancing patient access. The company is also strategically planning for future product launches and potential acquisitions to bolster its portfolio.