ARS Pharmaceuticals, Inc. Q4 FY2024 earnings call

• Neffy Launch and Clinical Data: Successfully launched neffy 2mg in Sep 2024 and secured FDA approval for 1mg dose for 15-30kg patients (23% of auto-injector market). Extensive clinical data presented at Quad AI meeting, real-world data from neffy Experience Program shows better outcomes than epinephrine injections.
• Commercialization: Engaged with ~9,000 healthcare providers, over 4,000 prescriptions via BlinkRx, ~2,500 allergists in Experience Program. Payer coverage: over 51% commercially insured without prior auth, aiming for 80% by summer 2025. Neffy in schools program, DTC campaign launching May 2025.
• Financials: Q4 2024 net income $49.9M ($0.51 basic EPS), full year 2024 net income $8M ($0.08 basic/diluted EPS). Ended 2024 with $314M in cash, cash equivalents, and short-term investments.

In the fourth quarter of 2024, neffy generated $6.7 million in net product revenue in the United States. For the full year 2024, neffy sales in the U.S. totaled $7.3 million. Total revenue for Q4 2024 was $86.6 million, including $6.7 million from neffy, $73.5 million from collaboration with ALK, $6 million from a licensing partner in Japan, and $0.4 million from supply agreements. Full year 2024 revenue was $89.1 million, with $7.3 million from neffy sales, $81.5 million from collaboration revenue, and $0.4 million from supply agreements.

• Payer Coverage: On track for 80% unrestricted commercial coverage by summer 2025, including Caremark, Anthem, Aetna on formulary by July 1.
• DTC Campaign: Planning $40-50M DTC campaign starting May 2025 for summer peak prescribing season.
• Global Expansion: Euro neffy approved in EU, UK submission under review, Canada, China, Japan submissions completed with decisions expected by year-end 2025.

• Prior Authorization: Administrative burden for doctors, low net revenue per prior authorization slowing adoption.
• FDA OTC Approval: Concerns about safety (overdose risk) and self-diagnosis criteria make OTC approval unlikely in near term.
• Market Adoption: Slow uptake due to prior authorization requirements and need for real-world data to convince some physicians.

Q: How does the ramp for 1mg neffy format compare to the 2mg product?

A: It's additive. The 1mg dose represents 23% of the market and is beneficial for younger children, and it's included in payer contracts.

Q: What percentage of the epinephrine market is direct to patients?

A: Very little currently. Working with kit manufacturers for airlines, but retail is the primary focus.

Q: What's the duration of prior authorization and its impact?

A: Varies by insurer; some require every time, others longer. But the company is on track for 80% coverage with no prior authorization.

Q: Tell us about the challenge clinic registry study for neffy?

A: It's the largest RCT, focusing on safety in real-world patients with concomitant conditions, with an interim analysis planned.

Q: What system is in place for patients/scripts after coverage?

A: BlinkRx tracks patients, sales force informs doctors, and a DTC campaign aligns with coverage to drive access.