ARS Pharmaceuticals (SPRY) investor relations material

Executive summary

• Q3 2025 marked a pivotal inflection point with neffy U.S. net product revenue reaching $31.3 million, a 2.5-fold increase from the prior quarter, surpassing consensus expectations and driven by DTC campaigns and market expansion.

• neffy, the first FDA- and EC-approved needle-free epinephrine, launched in the U.S. and EU, targeting a large unmet need in emergency allergic reaction treatment.

• Real-world data from over 680 patients confirm neffy's effectiveness is equivalent to injection products, with high single-dose resolution rates for anaphylaxis.

• Global expansion is underway with launches in Germany, U.K., and anticipated approvals in Japan, Canada, and China in 2025-2026.

• Surveys indicate high patient satisfaction and refill intent, with 95% of users likely to refill neffy compared to 31–39% for autoinjectors.

Financial highlights

• Q3 2025 revenue was $32.5 million, with $31.3 million from U.S. neffy sales and $1.1 million from supply revenue.

• Net loss for Q3 2025 was $51.2 million, or $0.52 per share, with a net loss margin of approximately 157%.

• Cash, cash equivalents, and short-term investments totaled $288.2 million as of September 30, 2025.

• SG&A expenses surged to $74.8 million, reflecting heavy investment in DTC marketing and commercialization.

• R&D expenses were $2.8 million in Q3, mainly for clinical trials and post-marketing studies.

Outlook and guidance

• Q4 sales expected to decrease from Q3 due to seasonality, but market share growth is anticipated to continue, with quarter-over-quarter growth expected to resume in 2026.

• International launches in Japan, Canada, and China expected to contribute to revenue in the second half of 2026.

• Cash position expected to fund operations through cash-flow breakeven without additional equity financing.

• FY2025 cash-based operating expense guidance is $210–$220 million.

• Topline data from Phase 2b urticaria trial anticipated mid-2026.