ARS Pharmaceuticals, Inc. Q2 FY2025 earnings call

• Neffy is experiencing commercial momentum with 93% commercial coverage in the U.S., making it accessible to most patients with commercial insurance.
• Weekly two-pack unit volume of neffy prescriptions increased by 180% from the end of Q1 to Q2 2025.
• Launched a national direct-to-consumer (DTC) campaign 'Hello neffy, Goodbye Needles' with phases starting in late May/June and expanding to linear TV in July.
• U.S. pediatric co-promotion with ALK was fully deployed in late June.
• ALK launched EURneffy in Germany in June and neffy was approved in the U.K. in July; additional regulatory decisions for neffy are expected in various countries by end of 2025 and 2026.
• Initiated a randomized controlled Phase IIb clinical trial in chronic spontaneous urticaria with top line data expected in H1 2026.
• Sales organization reached ~15,000 health care providers, with over 9,700 having dispensed prescriptions.
• 93% commercial coverage, with 57% of payers not requiring prior authorization, and prior authorization approval rates over 80% for those that do.
• Co-pay assistance program ensures most patients pay $25, with 95% of pharmacies automatically applying co-pay support.
• Substantial investments are being made in the launch of neffy, with a $50 million DTC campaign investment recognized in SG&A expenses in Q2 and Q3 2025.

For the second quarter of 2025, ARS Pharmaceuticals reported total revenue of $15.7 million. The net product revenue for neffy, the key product segment, was $12.8 million in Q2, representing a significant quarter-over-quarter growth. This $12.8 million in net product revenue from neffy contributed to the total revenue. Additionally, collaboration revenue included a $5 million milestone payment from ALK related to the launch of EURneffy in Germany in June, and $0.3 million in supply revenue from partners.

• Expect continued growth in neffy prescriptions in Q3 and Q4 2025, driven by the DTC campaign, U.S. pediatric co-promotion, and back-to-school season.
• Anticipate additional regulatory decisions on neffy in Canada, Australia, Japan by end of 2025 and in China by H1 2026.
• EMA approval of the 1-milligram pediatric dose in H1 2026 will trigger another $5 million milestone payment from ALK.
• Gross to net retention is expected to be maintained around 50%, providing predictability in revenue modeling.

• Actual results may differ materially from forward-looking statements.
• Potential regulatory delays in obtaining approvals in various countries.
• Payer access challenges remaining for some commercial payers.
• Market competition in the epinephrine treatment space.

Q: Can you confirm the number of prescriptions written or shipped during the quarter and early signs of DTC translating to prescribing behavior?

A: Net sales of $12.8 million translate to about 35,000 2-pack prescriptions in Q2, up from 19,000 in Q1. DTC campaign is gaining traction with aided awareness increasing, though impact typically seen 12-16 weeks after launch.

Q: What's the realistic ceiling for coverage without prior authorization and revenue impact of moving remaining Zinc portion?

A: No clear ceiling seen, with prior authorizations concentrating on companies not yet covering without prior authorization. Revenue impact not quantifiable exactly but expected to increase as coverage expands.

Q: Which levers drive growth in weekly scripts and timeline for DTC impact?

A: Levers include DTC campaign, U.S. pediatric co-promotion with ALK, and back-to-school season. DTC impact typically seen 12-16 weeks after launch, expecting impact during August/September peak.