ARS Pharmaceuticals reported robust third-quarter 2025 financial results, with total revenue reaching $32.5 million driven primarily by strong U.S. sales of neffy, the first and only FDA-approved needle-free epinephrine nasal spray for treating Type I allergic reactions including anaphylaxis. The San Diego-based biopharmaceutical company generated $31.3 million in net product revenue from neffy sales in the U.S. market during the quarter.
Commercial Momentum Accelerates Through Multi-Pronged Strategy
The company's comprehensive commercial approach has yielded measurable results across multiple metrics. Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma, emphasized the integrated nature of their strategy: "Our direct-to-consumer campaigns are generating measurable increases in patient awareness; real-world evidence data are further strengthening prescriber confidence in neffy's effectiveness; and we are implementing advertising programs such as a free virtual prescriber option and zero dollar co-pay to further reduce barriers for patients."
The direct-to-consumer campaign launched in late second quarter 2025 has significantly expanded market awareness, growing consumer recognition from approximately 20% pre-campaign to 56% as of September 2025. This awareness growth has translated into prescriber adoption, with over 18,000 healthcare providers now having prescribed neffy, representing an 86% increase from August 2025.
Real-World Evidence Supports Clinical Effectiveness
Clinical data presented at the American College of Asthma, Allergy and Immunology in early November 2025 provided compelling real-world evidence for neffy's effectiveness. An updated analysis of treatment outcomes involving 680 patients demonstrated that approximately 90% of patients experiencing anaphylaxis were effectively treated with a single dose of neffy. Importantly, this real-world effectiveness was found to be indistinguishable from historically reported epinephrine injection outcomes.
The neffy Experience Program has facilitated this data collection by providing 2 mg and 1 mg neffy doses to allergists for in-office use during anaphylaxis events occurring during oral food challenges or allergen immunotherapy. Approximately 2,800 allergists have enrolled in this program, with approximately 20,000 doses available across both strengths.
Market Access and Financial Performance
ARS Pharmaceuticals has achieved significant progress in market access, maintaining gross-to-net retention of at least 50% while working toward unrestricted payor access. The company's financial position remains strong with $288.2 million in cash, cash equivalents, and short-term investments as of September 30, 2025. This includes a $100 million drawdown from a new $250 million senior security term loan facility with affiliates of RA Capital Management and OMERS Life Sciences.
The company reported a net loss of $51.2 million, or $0.52 per share, for the third quarter, reflecting substantial investments in the national DTC marketing campaign and continued commercialization efforts. Selling, general and administrative expenses totaled $74.8 million for the quarter, demonstrating the company's commitment to market expansion.
Global Expansion Gains Momentum
International market development has accelerated significantly, with regulatory approvals and commercial launches expanding neffy's global footprint. In September 2025, Japan's Pharmaceutical and Medical Devices Agency granted approval for neffy 2 mg and 1 mg for emergency treatment of allergic reactions in adults and children weighing greater than 15 kg. Alfresa, which owns marketing rights in Japan, expects neffy availability in the fourth quarter of 2025.
European expansion has progressed with ALK successfully launching EUR neffy 2 mg in the United Kingdom in October 2025, representing entry into the largest market outside the United States for adrenaline auto-injector sales. EUR neffy had previously launched in Germany at the end of June 2025. The European Medicines Agency is currently reviewing EUR neffy 1 mg for children weighing 15 to less than 30 kg, with approval anticipated in the first half of 2026.
Additional regulatory approvals are expected for neffy in Canada with ALK-Abell in the first quarter of 2026, with launch expected in the first half of 2026. Regulatory approval in China through partnership with Pediatrix is anticipated in the first half of 2026.
Educational and Access Programs Show Impact
The company's educational initiatives have demonstrated measurable impact on market penetration. The neffyinSchools program has enrolled more than 6,500 schools, each receiving two cartons containing four single-use doses of neffy 2 mg or 1 mg at no cost for emergency use through the School Health Corp. SHConnect platform.
A new "Get neffy on Us" campaign was launched to eliminate time barriers and reduce costs by offering patients with current epinephrine auto-injector prescriptions or diagnoses the opportunity to switch to neffy via a free virtual provider at zero co-pay. Consumer surveys indicate that more than 70% of Type I allergy patients are open to using a virtual prescribing option.
Pipeline Development Continues
Beyond the core anaphylaxis indication, ARS Pharmaceuticals is advancing its intranasal epinephrine technology into new therapeutic areas. A Phase 2b clinical trial evaluating intranasal epinephrine for acute flares in patients with chronic spontaneous urticaria is currently enrolling patients in the U.S. and Europe, with topline data anticipated in mid-2026.
The company's post-marketing registry-based randomized controlled study of neffy for anaphylaxis treatment in oral food challenge or allergen immunotherapy clinics continues in the U.S., providing ongoing real-world evidence to support clinical adoption.
ARS Pharmaceuticals believes its current cash position will fund operations through expected cash-flow break-even, positioning the company to continue investing in neffy's commercial growth while expanding the clinical applications of its needle-free epinephrine delivery technology.
