Core Insights - ARS Pharmaceuticals reported a total revenue of $32.5 million for Q3 2025, with $31.3 million coming from U.S. net product revenue of neffy, the first FDA-approved needle-free epinephrine treatment for Type I allergic reactions [1][5] - The company has a strong cash position of $288.2 million, which is expected to support operations until cash-flow break-even [1][5] - The direct-to-consumer (DTC) marketing strategy has significantly increased consumer awareness of neffy from approximately 20% to 56% since its launch [5][11] Financial Performance - Total revenue for Q3 2025 was $32.5 million, including $31.3 million in net product revenue and $1.1 million in supply revenue [5][29] - Research and Development (R&D) expenses were $2.8 million, primarily for ongoing clinical trials and studies related to neffy [5][29] - Selling, General and Administrative (SG&A) expenses reached $74.8 million, reflecting substantial investment in DTC marketing and sales efforts [5][29] - The net loss for Q3 2025 was $51.2 million, or $0.52 per share [5][29] Commercial Launch and Strategy - The DTC campaign has been effective in increasing patient awareness and prescriber confidence in neffy's effectiveness [2][5] - Over 18,000 healthcare providers have prescribed neffy, marking an 86% increase since August 2025 [11] - The "Get neffy on Us" campaign aims to eliminate barriers for patients by offering a free virtual prescribing option and zero dollar co-pay [11] Market Expansion - neffy has received regulatory approval in Japan, with expectations for availability in Q4 2025 [11] - The launch of EURneffy in the U.K. occurred in October 2025, targeting the largest market outside the U.S. for adrenaline auto-injectors [11] - Additional regulatory approvals for neffy in Canada and China are anticipated in 2026 [11] Clinical Development - A Phase 2b trial for intranasal epinephrine technology is ongoing, with topline data expected in mid-2026 [7] - A post-marketing registry study for neffy is also underway in the U.S. [11]