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ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) has reported its financial results for the fourth quarter and full year of 2025, showcasing significant progress in the commercialization of neffy®, the first and only FDA-approved needle-free epinephrine treatment for Type I allergic reactions, including anaphylaxis. The company generated a net product revenue of $72.2 million from neffy sales in the U.S. During its first full year of availability.
Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, emphasized the importance of 2025 as a transformative year for the company. He noted that the establishment of neffy as a preferred treatment option positions ARS Pharma for accelerated market share growth in 2026. The company anticipates a notable shift as initial prescriptions reach their expiration and begin to renew.
ARS Pharma’s strong financial position is underscored by a balance sheet reflecting $245 million in cash, cash equivalents, and short-term investments, which is expected to support operations through anticipated cash-flow break-even. The company remains committed to expanding access to neffy and enhancing its marketing initiatives to increase adoption among healthcare providers and patients.
Financial Overview
Total revenue for the fourth quarter of 2025 reached $28.1 million, comprised of:
- $20.3 million in net product revenue from neffy sales in the U.S.
- $6.9 million in collaboration revenue from international partners.
- $0.9 million in supply revenue from partners.
For the full year 2025, the company reported total revenue of $84.3 million, which includes:
- $72.2 million from U.S. Neffy sales.
- $9.7 million from collaboration revenue.
- $2.4 million from supply agreements.
Research and Development (R&D) expenses for the fourth quarter were $3.4 million, totaling $13.2 million for the year. This investment primarily supports product development and clinical trials. Meanwhile, Selling, General and Administrative (SG&A) expenses amounted to $60 million for the fourth quarter and $230.1 million for the full year, reflecting a significant investment in direct-to-consumer marketing campaigns and sales efforts related to the U.S. Launch of neffy.
Commercial Launch and Market Access
In terms of market access, ARS Pharma continues to work with major payers to ensure that neffy is available without restrictions. Currently, eight state Medicaid plans cover neffy without prior authorization, and the company anticipates additional plans will include neffy in their preferred drug lists by 2026. Eligible commercially insured patients may obtain neffy with a $0 co-pay.
The company has launched an updated direct-to-consumer (DTC) advertising campaign designed to enhance awareness and adoption of neffy. This campaign, which began in January 2026, aims to highlight the product’s benefits and its compatibility with the lifestyles of patients who require emergency allergic reaction treatment.
Sales Force Expansion
To further bolster its market presence, ARS Pharma is increasing its sales force from 106 to 150 representatives in the second quarter of 2026. This expansion is intended to deepen relationships with high-prescribing allergists and their teams, thereby increasing the frequency of prescriptions.
Real-World Evidence and Adoption
The neffy Experience Program has demonstrated positive real-world treatment outcomes. A recent publication in the Annals of Allergy, Asthma and Immunology indicated that about 90% of patients effectively managed anaphylaxis with a single dose of neffy, outcomes comparable to traditional epinephrine injections. The program provides neffy samples to allergists for utilize during in-office emergencies.
ARS Pharma has initiated a campaign titled “Get neffy on Us,” aimed at easing the transition for patients switching from traditional epinephrine auto-injectors to neffy. As of now, approximately 10% of neffy prescriptions are facilitated through the program, and participation is expected to grow as integration with the new DTC advertising occurs.
Global Expansion and Future Directions
Looking beyond the U.S., ARS Pharma is advancing the global rollout of neffy, having received positive opinions from the European Medicines Agency (EMA) for marketing authorization in various European nations, as well as approvals in China and Australia. The company is eyeing additional regulatory approval in Canada, anticipated in mid-2026.
As part of its ongoing research efforts, ARS Pharma is conducting a Phase 2b trial evaluating neffy’s effectiveness for treating chronic spontaneous urticaria, with interim data expected in late 2026. These advancements could broaden the application of intranasal epinephrine technology and further solidify ARS Pharma’s role in managing allergic emergencies.
The company’s next steps will focus on solidifying its market position through strategic partnerships, enhancing patient education, and ensuring robust access to its innovative treatment option. As ARS Pharma continues to navigate the complexities of the healthcare landscape, its commitment to expanding neffy’s reach remains a priority.
For more updates on ARS Pharmaceuticals and neffy, follow the company on various platforms including X/Twitter and Instagram.
Please note that this article is for informational purposes only and does not constitute medical advice. Always consult a healthcare professional for medical guidance.