ARS Pharmaceuticals (SPRY) Q4 2025: NEFI Penetrates 22,500 Prescribers as Refill Dynamics Set Up 2026 Growth
ARS Pharmaceuticals ended its first full commercial year with NEFI gaining traction in high-value practices, but refill-driven market structure delayed linear growth. Strategic sales force expansion and digital initiatives are set to drive broader adoption and unlock the renewal flywheel in 2026. Investors should watch for access expansion and refill volume as key inflection points for durable revenue growth.
Summary
- Prescriber Concentration Drives Early Traction: NEFI’s adoption is anchored in high-decile allergists and pediatricians, validating targeted field execution.
- Refill Market Structure Delays Growth Curve: Renewal cycles and legacy auto-injector habits slow immediate ramp, but set up a tailwind as NEFI base matures.
- Resource Reallocation Funds Sales Force Expansion: Commercial spend optimization supports increased engagement without raising SG&A, positioning for improved execution in 2026.
Performance Analysis
ARS Pharmaceuticals’ first full commercial year for NEFI, its needle-free epinephrine, generated $72.2 million in U.S. net product revenue, a figure management emphasizes as the clearest indicator of real market penetration. The remainder of total revenue came from collaboration agreements and international supply, but U.S. prescription uptake is the primary barometer for long-term commercial viability. NEFI’s launch faced the typical headwinds of a mature, refill-dominated category, with refill inertia and electronic prescribing workflows slowing the ramp for a new entrant.
Prescriber adoption surpassed 22,500 healthcare providers, with half writing repeat prescriptions. However, the refill-driven nature of the market means that the bulk of NEFI prescriptions remain new rather than renewals, as legacy auto-injectors benefit from decades of embedded renewal behavior. With approximately 93% commercial coverage achieved, but only 57% of covered lives enjoying unrestricted access, administrative friction from prior authorizations continued to impact conversion rates and volume consistency.
- Sales Force Expansion Targets Priority Accounts: Planned increase from 106 to 150 reps, funded by reductions in market research and select marketing spend, aims to deepen engagement in high-value practices.
- Digital Conversion Gaining Traction: The Get NEFI on Us program now accounts for over 10% of prescriptions, streamlining access and accelerating patient transitions.
- Gross-to-Net Retention Remains Stable: With gross-to-net in the low to mid 50% range, management expects predictability and leverage to improve as access broadens and prior auths decline.
Cash discipline is evident with $245 million on hand and breakeven targeted without incremental SG&A escalation, supporting both U.S. commercialization and pipeline development through at least 2026.
Executive Commentary
"2025 was our first full year for ARS as a commercial company. It was a year focused on building infrastructure, educating the market, and learning as we introduce a new treatment into a well-established therapeutic category... Growth has not yet followed a linear trajectory, consistent with products launched in a mature refill-driven market."
Richard Lowenthal, Co-Founder, President, and CEO
"These investments were intentional and strategic, designed to build durable market share and long-term brand equity. As noted, we are preparing to expand our sales force from 106 to 150, beginning in the second quarter of 2026... This approach reflects a more focused and execution-driven phase of the launch."
Kathy Scott, Chief Financial Officer
Strategic Positioning
1. High-Value Prescriber Penetration
NEFI’s early adoption is concentrated among decile 7 to 10 allergists and pediatricians, representing 80% of prescription volume. This validates ARS’s targeted field strategy, but also means broader penetration will require workflow integration and administrative buy-in beyond early adopters.
2. Refill Dynamics and Workflow Integration
Market renewal inertia remains a core barrier: About half of all epinephrine prescriptions are refills, most written electronically without office visits. NEFI’s growth will increasingly depend on embedding itself into electronic renewal systems and capturing the switch at the point of prescription renewal, not just initial adoption.
3. Digital and DTC Leverage
Direct-to-consumer (DTC) campaigns have driven aided awareness from 20% to 60%, and the Get NEFI on Us digital platform now facilitates over 10% of prescriptions. This infrastructure is designed to reduce friction and capture patients seeking alternatives to needle-based auto-injectors, with management expecting digital conversion to become a larger share of volume as awareness builds.
4. Resource Optimization, Not Expansion
Sales force growth is funded by reallocating spend from lower-yield activities, such as market research, select advertising, and non-core initiatives. This signals a disciplined capital allocation approach, with no planned increase in overall SG&A in 2026 despite the field expansion.
5. Pipeline and International Opportunity
International partners are advancing NEFI regulatory approvals across Europe, China, Japan, and Australia, while the chronic spontaneous urticaria (CSU) program is on track with Phase 2b data expected in the second half of 2026. CSU offers a potential market as large as anaphylaxis, setting up a second commercial pillar if clinical milestones are met.
Key Considerations
The 2025 launch year for NEFI clarified both the opportunity and the operational complexity of disrupting a mature, refill-driven epinephrine market. ARS’s strategic focus in 2026 is on execution precision—deepening prescriber engagement, optimizing digital conversion, and embedding NEFI in renewal workflows.
Key Considerations:
- Refill Tailwind Timing: Meaningful refill volume will not materialize until late 2026 or 2027, as initial prescriptions reach expiration and renewal cycles begin to favor NEFI.
- Access Expansion Pace: Ongoing negotiations with CVS Caremark and other major PBMs will determine how quickly NEFI can move from 93% coverage to broader unrestricted access, reducing prior auth friction.
- Sales Force Productivity: The shift from market research to field execution must drive higher engagement and conversion in priority accounts to realize planned growth without raising costs.
- DTC and Digital Integration: The effectiveness of the Get NEFI on Us program and new creative campaigns will be tested as ARS seeks to translate awareness into prescription growth and renewal intent.
Risks
Key risks include slower-than-expected refill adoption, persistent administrative barriers (especially prior authorizations), and competitive pushback from entrenched auto-injector brands. Failure to secure unrestricted PBM coverage or to embed NEFI in electronic renewal workflows could delay the anticipated growth inflection, while international launches and pipeline milestones remain subject to regulatory and clinical uncertainties.
Forward Outlook
For Q1 and Q2 2026, ARS expects:
- Sales force expansion from 106 to 150 reps, with no increase in overall SG&A expense
- DTC and healthcare provider campaign spend to remain consistent with 2025 levels (approximately $100 million)
For full-year 2026, management maintained guidance:
- SG&A run rate neutral to 2025, despite field expansion
- Gross-to-net retention targeted at ~50% steady state
Management highlighted several factors that will shape the year:
- Renewal and refill contribution should begin to emerge in late 2026 as the installed NEFI base matures
- PBM and Medicaid access expansion, particularly with CVS Caremark in July, is expected to unlock additional volume
Takeaways
NEFI’s first year established strong prescriber buy-in among high-value accounts, but refill-driven market mechanics delayed the revenue ramp. The real test begins in 2026 as ARS Pharmaceuticals pivots to workflow integration and broader digital engagement to capture the renewal flywheel.
- Prescriber Targeting Validated: Adoption by over 22,500 providers, with repeat writing concentrated in top decile practices, confirms the effectiveness of ARS’s focused field strategy.
- Renewal Dynamics Remain the Key Growth Lever: The transition from new prescriptions to refill-driven volume will determine the sustainability and scalability of NEFI’s revenue trajectory.
- Execution and Access Expansion Will Drive 2026: Investors should monitor PBM coverage wins, refill trends, and digital program conversion rates as leading indicators of future performance.
Conclusion
ARS Pharmaceuticals exits its initial commercial year with NEFI gaining traction but facing the headwinds of a refill-dominated market. Disciplined resource reallocation, digital platform expansion, and upcoming access milestones position the business for a more consistent growth trajectory as the renewal base builds in 2026 and beyond.
Industry Read-Through
NEFI’s experience highlights the structural hurdles new entrants face in mature, refill-centric therapeutic categories, where workflow inertia and electronic prescribing dominate. For biopharma peers, success depends not just on clinical differentiation but on embedding products into renewal systems and digital workflows. The DTC and virtual conversion model pioneered here could become a template for other specialty launches seeking to disrupt entrenched prescription behaviors. PBM access and administrative friction remain the gating factors for both volume and margin expansion across the sector.