ARS Pharmaceuticals (NASDAQ:SPRY) executives used the company’s fourth-quarter and full-year 2025 earnings call to outline early commercial progress for neffy, its needle-free epinephrine option for Type I allergic reactions including anaphylaxis, while emphasizing that growth in the category has been shaped by refill-heavy prescribing behavior and payer-driven administrative hurdles.
First full commercial year: revenue and real-world data
Co-founder, President and CEO Richard Lowenthal said 2025 marked ARS’ first full year as a commercial company, focused on “building infrastructure, educating the market, and learning” as it introduced a new treatment into an established therapeutic category. He highlighted real-world data from the company’s neffy Experience Program, published in the Annals of Allergy, Asthma & Immunology, which showed that about 90% of patients experiencing anaphylaxis were effectively treated with a single dose—results the company said are consistent with published outcomes for injection-based epinephrine products.
Commercial launch dynamics: refills, e-prescribing, and seasonality
Management repeatedly pointed to structural market dynamics that have affected quarter-to-quarter performance. Lowenthal said neffy’s progression has been shaped by refill dominance in the epinephrine category, electronic prescribing patterns, prior authorization requirements, and seasonal factors such as deductible resets and back-to-school demand.
Chief Commercial Officer Eric Karas said approximately half of epinephrine prescriptions are refills and the majority are written electronically without an office visit. As a result, the company believes success requires not only influencing clinical preference but also integrating into office workflows and electronic renewal processes. Lowenthal said legacy auto-injectors benefit from decades of embedded renewal behavior within physician workflows, while neffy has relied primarily on new prescriptions and has not yet benefited from expirations that could drive renewals.
On refills, management said it is seeing some refills now, largely from patients seeking additional product or replacing used product, but does not expect expiration-driven refill dynamics to begin until late 2026. Lowenthal added that some earlier renewal activity could occur during the summer back-to-school period, when families often ensure epinephrine prescriptions will last through the school year. He noted that many initial launch lots are expected to begin expiring at the end of 2026 and into early 2027.
Adoption, sales force expansion, and “Get neffy on Us”
Karas said that as of year-end 2025, more than 22,500 healthcare providers had prescribed neffy, representing significant growth from mid-year levels. He added that 50% of prescribers are repeat writers, and prescriptions remain concentrated among high-decile allergists and pediatricians, with roughly 80% generated by decile seven to ten prescribers.
To increase engagement in priority accounts, management said it plans to expand the field organization from 106 to 150 beginning in the second quarter of 2026 and realign territories to increase interaction frequency. Karas said internal analysis suggests prescriber change in high-volume accounts requires consistent engagement—at least three calls per month—with both physicians and administrative staff who manage electronic prescribing systems.
Executives said the sales force expansion will be funded through reallocation of existing commercial resources and is expected to be neutral to overall SG&A run rate in 2026. In response to analyst questions, management cited reductions in lower-yield spending areas such as certain market research efforts, select conference activity, and other promotional budget optimizations.
ARS also emphasized its virtual and digital strategy. Lowenthal described the company’s “Get neffy on Us” program at getneffy.com, which offers commercially insured patients a free virtual visit with a prescriber and a zero copay for eligible patients, aiming to reduce administrative barriers and help patients transition from auto-injectors to neffy. Karas said approximately 10% of neffy prescriptions are currently facilitated through the program, and he expects that share to expand over the next 12 months as awareness grows and the company more tightly integrates direct-to-consumer outreach with digital conversion pathways.
Payer access: coverage levels and prior authorization friction
Access was a central theme on the call, with management characterizing prior authorization as a meaningful friction point in a high-volume category. Lowenthal said ARS ended 2025 with about 93% overall commercial coverage, inclusive of plans that may still require prior authorization; about 57% of covered lives have access without prior authorization. Karas said that for plans requiring prior authorization, approval rates are approximately 55%.
The company said discussions are ongoing with CVS Caremark, and executives also cited a focus on Anthem, Aetna, and large regional payers. In Medicaid, Karas said ARS has secured unrestricted coverage in eight states, while other states require prior authorization. He said the company is working to reduce barriers and ensure affordability, particularly in high-volume states.
On timing, management told analysts it expects to have more confidence in coverage expansion “very shortly” and said CVS Caremark typically implements formulary changes on July 1, while other payers can move faster. The company said it expects “fairly substantial expansion” of coverage heading into the summer and noted ongoing work to expand Medicaid coverage.
Spending levels, balance sheet, and pipeline updates
Scott reported 2025 R&D expense of $13.2 million and SG&A expense of $230.1 million, reflecting commercialization investments including DTC and the sales team. She said year-end 2025 gross-to-net was in the low-to-mid 50% range, and the company continues to target gross-to-net retention of around 50% at steady state.
In Q&A, management said direct-to-consumer and direct-to-healthcare provider advertising spend in 2026 is expected to be similar to 2025 levels, which executives estimated at roughly $100 million combined. Karas said the company can track consumer behavior from some advertising channels to website activity and prescriptions, and he also pointed to survey results showing ad recall in the “mid to upper 50s.”
ARS ended 2025 with $245 million in cash, cash equivalents, and short-term investments. Scott said the cash position is expected to be sufficient to fund the ongoing U.S. commercial expansion of neffy, continued DTC and field execution investments, and advancement of the company’s chronic spontaneous urticaria (CSU) program through expected cash flow breakeven.
On the pipeline, Lowenthal said ARS expects interim data in the second half of 2026 from its ongoing Phase 2b trial in CSU flares, remains on track to finish the study by the end of 2026, and anticipates starting Phase 3 in mid-2027. He also said international partners continue to pursue regulatory approvals across Europe, China, Japan, and Australia, with partner-led launches expected in 2026.
About ARS Pharmaceuticals (NASDAQ:SPRY)
ARS Pharmaceuticals, Inc, a biopharmaceutical company, develops treatments for severe allergic reactions. The company is developing neffy, a needle-free and low-dose intranasal epinephrine nasal spray for the emergency treatment of Type I allergic reactions, including anaphylaxis. It serves healthcare professionals, patients, and caregivers. ARS Pharmaceuticals, Inc was founded in 2015 and is headquartered in San Diego, California.
