ARS Pharmaceuticals (SPRY) Q1 2025: NEFI Coverage Doubles to 57%, Tipping Point for Needle-Free Epinephrine

May 14, 2025 | By EarningsIQ Research

ARS Pharmaceuticals accelerated NEFI’s commercial reach in Q1 2025, doubling insurance coverage and laying the groundwork for a pivotal back-half inflection. With the pediatric dose now FDA-approved and a $40–50M direct-to-consumer campaign launching, management is betting heavily on mainstream adoption and market share gains as peak allergy season approaches.

Summary

• Insurance Access Surges: NEFI’s commercial coverage reached 57%, up from 27% at year-end, unlocking broader prescriber adoption.
• Pediatric Expansion Accelerates: FDA approval and launch of the 1mg dose positions NEFI for outsized pediatric share gains in summer and fall.
• DTC Investment Sets Up H2 Inflection: A major direct-to-consumer campaign aims to drive prescription growth as NEFI pursues standard-of-care status.

Performance Analysis

Q1 marked NEFI’s first full quarter of commercialization, with $7.8 million in U.S. net product revenue reflecting early traction among physicians and patients seeking alternatives to traditional epinephrine autoinjectors. The company reported total revenue of $8 million, including collaboration revenue from ALK, allergy care partner. Notably, NEFI’s insurance coverage more than doubled from 27% to 57% of U.S. commercial lives, a critical lever for accelerating adoption as prior authorization hurdles fall away. Management emphasized that Q1 revenue was not materially influenced by inventory build, with steady channel inventories and all sales attributed to the original 2mg dose prior to the 1mg pediatric launch.

Operating expenses were dominated by sales, general, and administrative spend at $41.1 million, reflecting the company’s aggressive investment in commercialization and the ramp-up for a nationwide direct-to-consumer (DTC) campaign. Cost of goods sold (COGS) remained low, benefiting from pre-approval inventory, but is expected to trend up as zero-cost stock is depleted. The company posted a net loss of $33.9 million, but maintains a cash runway of at least three years, enabling sustained investment through the expected inflection in the second half of 2025.

• Coverage Expansion Drives Prescriber Uptake: 57% of U.S. commercial lives now have NEFI access with no prior authorization, up from 27% at year-end.
• Pediatric Dose Launch Unlocks New Market: The 1mg NEFI, now in pharmacies, addresses a segment representing 23% of all epinephrine units and over half of pediatric prescriptions.
• Physician Engagement and Experience: Over 2,500 healthcare providers joined the NEFI Experience Program, with participants prescribing at 2.5–3x the national average.

With peak allergy season and the DTC campaign ahead, ARS is positioned for a meaningful step-up in prescriptions and market share, particularly in the pediatric segment where the new dose and expanded outreach are expected to drive outsized gains.

Executive Commentary

Strategic Positioning

1. Insurance Coverage as a Growth Catalyst

Doubling NEFI’s insurance coverage to 57% of U.S. commercial lives is the single largest unlock for prescriber and patient adoption. Management expects this to reduce friction for both providers and patients, as prior authorization requirements fall and NEFI becomes a more routine prescription. With ongoing negotiations targeting 80%+ coverage by Q3, ARS is approaching a tipping point that could convert NEFI from niche alternative to mainstream option.

2. Pediatric Market Penetration

The approval and rapid pharmacy availability of NEFI’s 1mg pediatric dose addresses a critical unmet need, as more than half of all pediatric epinephrine prescriptions fall into this weight range. The company is leveraging its expanded partnership with ALK Abello to reach 20,000 healthcare providers, including 9,000 pediatricians, aiming to accelerate market share gains among children and families—segments historically underserved due to needle anxiety and portability concerns.

3. DTC Campaign and Consumer Awareness

The launch of a $40–50 million direct-to-consumer campaign, “Hello NEFI, Goodbye Needles,” is designed to establish NEFI as a household name and standard of care, reaching up to 95% of severe allergy patients and caregivers. By front-loading this spend ahead of peak prescribing season, ARS is betting on a Q3 inflection in demand and a durable step-up in brand recognition and prescription growth.

4. Physician Engagement and Real-World Evidence

The NEFI Experience Program has become a powerful lever for prescriber conversion, with participating physicians writing significantly more prescriptions and providing positive real-world feedback. Early survey data indicates NEFI’s efficacy and dosing profile closely mirrors traditional injectors, supporting broader adoption and peer-to-peer advocacy.

5. Global Expansion Pipeline

Regulatory reviews for NEFI are underway in the U.K., Canada, Japan, China, and Australia, with launches expected from mid-2025 through 2026. While the U.S. remains the near-term focus, these international markets represent a long-term growth vector as ARS builds its global commercial infrastructure.

Key Considerations

Q1 2025 reflects a pivotal transition from early launch to broad-based commercialization, with ARS Pharmaceuticals making large-scale investments to capture market share and establish NEFI as the new standard in epinephrine delivery.

Key Considerations:

• Insurance Coverage Momentum: Rapidly rising coverage is reducing prescribing barriers and should further accelerate as large PBMs (pharmacy benefit managers) come online.
• Pediatric Dose Timeliness: The 1mg launch is well-timed for summer travel and back-to-school, aligning with peak pediatric demand.
• Commercial Spend and Cash Runway: Heavy SG&A and DTC investment will pressure near-term margins, but the $275.7 million cash balance provides strategic flexibility.
• Physician Conversion Engine: The NEFI Experience Program is driving outsized engagement among high-volume prescribers, reinforcing the importance of hands-on clinical exposure for new therapies.
• International Optionality: Near-term U.S. execution is the focus, but global regulatory progress could add incremental upside in 2026 and beyond.

Risks

Key risks include slower-than-expected payer adoption or delays in reaching 80%+ commercial coverage, which could prolong prior authorization headwinds and limit prescription growth. Aggressive DTC spend may not deliver the expected step-change in demand, creating margin pressure if revenue lags. Competitive response from established autoinjector brands, regulatory delays abroad, and execution risk in scaling pediatric and global channels also warrant close monitoring.

Forward Outlook

For Q2 and Q3 2025, ARS expects:

• Peak DTC campaign spend and corresponding SG&A impact, with benefits expected to materialize in Q3 prescription growth.
• Continued ramp in insurance coverage, targeting 80%+ by Q3, unlocking broader prescriber base.

Full-year 2025 guidance:

• Operating expenses of $210–220 million (excluding stock-based comp and COGS), reflecting DTC and pediatric market investments.

Management highlighted:

• Q3 as the expected inflection point for sales, driven by peak pediatric demand and DTC campaign effects.
• Cash runway of at least three years to support execution and international expansion.

Takeaways

NEFI’s Q1 performance and execution set the stage for a high-stakes second half, with insurance coverage, pediatric access, and consumer awareness converging as core growth drivers.

• Market Access Unlock: The doubling of insurance coverage is the most material unlock for NEFI adoption, reducing prior auth friction and expanding the prescriber pool.
• Pediatric and DTC Catalysts: The pediatric dose and aggressive DTC push are both well-timed for seasonal demand, with management expecting a pronounced Q3 inflection in prescriptions and share.
• Execution Watchpoints: Investors should track insurance coverage progress, DTC campaign ROI, and market share capture among pediatric and high-volume prescribers as leading indicators of long-term value creation.

Conclusion

ARS Pharmaceuticals is executing a bold, high-investment strategy to make NEFI the new standard in epinephrine delivery, with insurance access, pediatric reach, and consumer awareness all set to converge in the coming quarters. The company’s ability to convert these investments into sustainable market share gains will define its trajectory through 2025 and beyond.

Industry Read-Through

NEFI’s rapid coverage expansion and DTC-driven strategy signal a new era for specialty drug commercialization, especially in markets where device innovation addresses unmet patient needs (needle anxiety, portability). The success of hands-on physician experience programs and targeted pediatric launches will be closely watched by other pharma and medtech players seeking to displace entrenched delivery modalities. For payers and competitors, the accelerating shift toward patient-friendly, insurance-accessible alternatives is likely to drive both pricing and access pressures across the allergy and acute care landscape.

SPRY Healthcare Biotechnology Commercialization Pediatrics DTC Market Access