ARS Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

Core Insights - ARS Pharmaceuticals reported a total net product revenue of $7.3 million from neffy® (epinephrine nasal spray) in the U.S. for 2024 since its launch in late September 2024 [1] - The FDA approved neffy 1 mg for children aged four and older, expanding its market to approximately 2 million younger children at risk of severe allergic reactions [1][2] - The company ended 2024 with $314.0 million in cash, cash equivalents, and short-term investments, ensuring a financial runway for at least three years [1][7] Financial Performance - Total revenue for Q4 2024 was $86.6 million, including $6.7 million from neffy sales and $73.5 million from collaboration revenue with ALK [5] - Full-year 2024 revenue totaled $89.1 million, reflecting a significant increase from previous years [5][22] - Net income for Q4 2024 was $49.9 million, translating to $0.51 per share basic and $0.48 diluted, while full-year net income was $8.0 million, or $0.08 per share [5][22] Business Developments - The U.S. commercial launch of neffy has seen strong execution, with increasing physician adoption and positive patient feedback [2][6] - The company engaged with approximately 9,000 priority healthcare providers, with over 4,000 healthcare providers submitting neffy prescriptions [7] - ARS Pharma plans to initiate a Phase 2b clinical trial for intranasal epinephrine as a treatment for chronic spontaneous urticaria in Q2 2025 [8] Market Expansion - The company anticipates receiving milestone payments from ALK of approximately $5 million in 2025, with half recognized as revenue [7] - neffy is expected to be available in pharmacies for pediatric use starting May 2025 [7] - Regulatory submissions for neffy in the U.K. and Canada are underway, with decisions anticipated by mid-2025 and year-end 2025, respectively [7] Strategic Initiatives - A broad direct-to-consumer marketing campaign for neffy is set to launch in May 2025, targeting the peak epinephrine prescribing season [7] - The neffyinSchools program aims to provide eligible K-12 schools with free neffy doses for emergency use [7] - The company has secured favorable coverage decisions from major payers, aiming for over 60% access to commercial lives by Q1 2025 [7]