ARS Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $37.7 million, up from $32.5 million in Q3 2025.
• U.S. net product revenue for neffy was $33.4 million in Q3 2026, compared to $31.3 million in Q3 2025.
• Supply revenue was $2.6 million and collaboration revenue was $1.7 million in Q3 2026.
• Total operating expenses were $71.9 million in Q3 2026, compared to $85.7 million in Q3 2025.
• SG&A expenses were $43.5 million in Q3 2026, a reduction from $74.8 million in Q3 2025, representing a 42% decrease from the first-half 2026 quarterly average.
• R&D expenses were $18.3 million in Q3 2026, compared to $2.8 million in Q3 2025, primarily due to a one-time $12.5 million payment for exclusive worldwide IP rights.
• Net loss was $35.6 million, or $(0.36) per share, in Q3 2026, compared to a net loss of $51.2 million, or $(0.52) per share, in Q3 2025.
• Cash, cash equivalents, and short-term investments totaled $138.4 million as of September 30, 2026.
• Total liabilities increased to $263.4 million as of September 30, 2026, from $213.4 million as of December 31, 2025.
• Stockholders' deficit was $(11.96) million as of September 30, 2026, compared to equity of $114.3 million as of December 31, 2025.

Guidance and Future Outlook:

• The company reaffirmed its path to cash flow breakeven by the end of 2027.
• Operating expenses are tracking in line with second-half 2026 guidance of $114 million to $126 million in aggregate SG&A and R&D expenses, including stock-based compensation.
• Interim Phase 2b data for ARS-2 is expected in the first quarter of 2027, with full data expected later in 2027.
• Management expects steady market share gains and a durable growth trajectory for neffy through targeted provider engagement.

Business Segments and Product Lines:

• neffy U.S. market share reached 5% in Q3 2026, up from 4% in Q3 2025.
• neffy market share in field-targeted accounts reached 9% in Q3 2026, up from 6% in Q3 2025.
• neffy market share in non-targeted accounts was 2% in Q3 2026.
• The total unique prescriber base for neffy reached 19,605 in Q3 2026, a 49% increase from Q3 2025, with over 44,000 prescribers since launch.
• ARS-2 is in a Phase 2b trial evaluating needle-free epinephrine for breakthrough flares in chronic spontaneous urticaria (CSU).
• The company is executing a shift to an account-based targeting strategy with sharper provider-focused messaging.

Market and Competitive Landscape:

• Field-targeted accounts represent approximately 44% of the total market opportunity.
• neffy is the only needle-free epinephrine approved by the FDA for emergency treatment of Type I allergic reactions in adults and children weighing 33 lbs. or more.
• The product is marketed as EURneffy® in the EU and 优敏速® in China.
• Management stated that neffy wins when providers are engaged directly, positioning it as a potential standard of care in the epinephrine market.

Risks and Challenges:

• Potential safety and other complications from neffy.
• Risk of regulatory approval maintenance or scope changes.
• Personnel costs could be higher than anticipated.
• Potential for governments and payors to delay, limit, or deny coverage for neffy.
• Competition from intramuscular injectable products regarding market acceptance.
• Adverse effects of pending litigation.
• Risks associated with clinical trial results and the ability to protect intellectual property.

Management Commentary and Tone:

• CEO Donn Casale stated the team delivered on three corporate priorities: steady market share gains, financial discipline with a path to cash flow breakeven by 2027, and platform expansion.
• CMO Randall Kaye and Chief Legal Officer John Slebir were appointed to strengthen the leadership team.
• CCO Meg Smith expressed confidence that neffy can become the standard of care and noted decisive actions taken to shift commercial operations to account-based targeting.
• Management highlighted a "three-pillar growth strategy" focusing on capturing market share, expanding the epinephrine market, and extending the platform to CSU.

Other Key Points:

• Leadership team appointments include Randall Kaye, M.D., M.P.H., as Chief Medical Officer and John Slebir as Chief Legal Officer and Corporate Secretary.
• A one-time $12.5 million payment was made in Q3 2026 for exclusive worldwide rights to certain intellectual property.
• The company is developing ARS-2 as a potential first treatment for acute breakthrough flares of chronic spontaneous urticaria, a market with an estimated two million Americans affected and no FDA-approved therapy for acute flares.
• The company hosts a conference call and webcast for investors and media.