ARS Pharmaceuticals Reports First Quarter 2025 Financial Results and Highlights Progress in U.S. Commercial Launch of neffy® (epinephrine nasal spray)

Core Insights - ARS Pharmaceuticals reported total revenue of $8.0 million for Q1 2025, with $7.8 million coming from neffy sales and $0.2 million from collaboration revenue with ALK-Abelló [5][21] - The company is focused on the U.S. commercial launch of neffy, a needle-free epinephrine nasal spray approved for treating severe allergic reactions, including anaphylaxis [1][10] - A co-promotion agreement with ALK-Abelló has expanded neffy's promotional reach to nearly 20,000 healthcare providers, enhancing market access [1][5] Financial Performance - Total revenue for Q1 2025 was $8.0 million, with net product revenue from neffy sales at $7.8 million and collaboration revenue at $0.2 million [5][27] - R&D expenses were $3.0 million, primarily for neffy's clinical and development costs [5] - SG&A expenses totaled $41.1 million, mainly for personnel and marketing related to neffy's commercialization [5] - The net loss for Q1 2025 was $33.9 million, equating to $0.35 per share [5][27] - As of March 31, 2025, the company had cash and short-term investments totaling $275.7 million, supporting operations for at least the next three years [5][21] Commercial Launch Progress - neffy 1 mg is now available nationwide for children aged four and older, with the 2 mg dose available for adults and older children [5][10] - Over 5,000 physicians have prescribed neffy, indicating strong demand for this treatment option [1][6] - The company is launching a national direct-to-consumer marketing campaign to increase brand awareness and drive demand [5][6] Market Access and Engagement - The sales force has engaged over 10,000 healthcare providers, with more than 50% having prescribed neffy [11] - Approximately 57% commercial coverage has been secured, with ongoing discussions to achieve over 80% access by early Q3 2025 [11][12] - More than 1,000 schools have opted into the neffyinSchools program, receiving free doses for emergency use [11][12] Clinical Development - ARS Pharma plans to initiate a Phase 2b clinical trial in Q2 2025 to evaluate intranasal epinephrine for chronic spontaneous urticaria [8] - Regulatory reviews for neffy are ongoing in the U.K. and Canada, with expected decisions by mid-2025 [12]