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Sep 30
ARS Pharmaceuticals Q3 2025 Earnings Report
ARS Pharmaceuticals reported its third quarter 2025 financial results and highlights for neffy® (epinephrine nasal spray).
Key Takeaways
ARS Pharmaceuticals reported strong third quarter 2025 results, with total revenue of $32.5 million, driven primarily by neffy U.S. net product revenue of $31.3 million. The company continues to invest heavily in direct-to-consumer marketing and real-world evidence for neffy, and maintains a strong cash balance of $288.2 million, expected to fund operations through cash-flow break-even. Net loss for the quarter was $51.151 million, or $0.52 per share.
Total revenue for Q3 2025 was $32.5 million, a significant increase from $2.068 million in Q3 2024.
Neffy U.S. net product revenue reached $31.3 million in Q3 2025.
The company reported a net loss of $51.151 million, or $0.52 per share, for the quarter.
Cash, cash equivalents, and short-term investments totaled $288.2 million as of September 30, 2025, anticipated to fund operations through cash-flow break-even.
ARS Pharmaceuticals
ARS Pharmaceuticals
ARS Pharmaceuticals Revenue by Segment
ARS Pharmaceuticals Revenue by Geographic Location
Revenue by Segment
Neffy U.S. Net Product Revenue
CapyFin.comRevenue under Collaboration Agreements Revenue
CapyFin.comRevenue under Supply Agreements Revenue
CapyFin.comRevenue by Geographic Location
United States Revenue
CapyFin.comGermany Revenue
CapyFin.com Forward Guidance
ARS Pharmaceuticals anticipates continued growth for neffy, with further market expansion and regulatory approvals in new geographies. The company expects its current cash position to fund operations through cash-flow break-even.
Positive Outlook
- Anticipated unrestricted payor access for neffy with a steady-state gross-to-net retention of at least 50%.
- Expected regulatory approvals for neffy in Canada and China in Q1 and H1 2026, respectively, with launches to follow.
- Anticipated approval for EURneffy® 1 mg by EMA in H1 2026.
- Topline data from the Phase 2b urticaria trial expected in mid-2026, potentially expanding intranasal epinephrine technology into this indication.
- Current cash position of $288.2 million is expected to fund operations through cash-flow break-even.
Challenges Ahead
- Potential safety and other complications from neffy.
- Risk in maintaining regulatory approval for neffy in its currently approved indications.
- Risk that ARS Pharma may not realize its expected return on investment from its DTC campaign.
- Potential for governments and payors to delay, limit or deny coverage for neffy.
- Impact of government laws, regulations and policies on the company's operations.