ARS Pharmaceuticals (SPRY) Q3 2025: NEFI U.S. Revenue Jumps 2.5x, DTC and Global Expansion Set Stage for 2026
NEFI’s rapid U.S. revenue ramp and strong refill intent mark a critical inflection, as ARS Pharmaceuticals leverages direct-to-consumer and global launches to expand its reach. Administrative barriers and seasonality remain headwinds, but new access programs and international rollouts position the company for sustained growth. Investor focus now shifts to execution on refill rates, label expansion, and the durability of NEFI’s competitive advantage.
Summary
- NEFI U.S. Launch Outpaces Expectations: Accelerated adoption and refill intent signal sustainable market share gains.
- DTC and Virtual Prescriber Initiatives: New access programs are designed to mitigate seasonality and administrative friction.
- Global Expansion and Pipeline Progress: International launches and label expansion trials set up multi-year growth catalysts.
Performance Analysis
ARS Pharmaceuticals delivered a pivotal Q3, with NEFI, its nasal epinephrine spray, driving a 2.5x sequential increase in U.S. net product revenue. The company’s U.S. net product revenue for NEFI reached $31.3 million, outpacing consensus and reflecting robust demand, particularly from new patient starts and recurring refills. This growth was achieved despite known limitations in IQVIA script data, which underrepresents non-retail and bulk institutional channels that are increasingly material for NEFI’s distribution model.
Gross-to-net retention modestly improved as cash prescriptions declined to 12% of volume, aided by copay optimization and channel management. Direct-to-consumer (DTC) marketing and the Get NEFI on Us program drove a surge in consumer awareness (from 20% to 56%) and intent to switch, with 80% of surveyed patients highly likely to ask for NEFI. Notably, NEFI is not only converting existing injector users but also reactivating lapsed patients and capturing new ones deterred by needle anxiety, expanding the total addressable market. International launches in Germany and upcoming approvals in Japan, Canada, and China are expected to contribute to revenue in 2026, while a Phase IIb urticaria trial advances a major label expansion opportunity.
- Channel Complexity Obscures Script Data: IQVIA undercounts NEFI’s true market share by omitting specialty, institutional, and bulk orders.
- Seasonality and Admin Burden Temporarily Slow Growth: Back-to-school surge constrained HCP time, pausing share gains, but management expects a rebound post-Q4.
- Cash Position Supports Aggressive Investment: $288 million in liquidity and a $250 million term loan facility enable continued DTC and global growth initiatives without equity dilution.
SG&A expenses rose as expected with DTC investment, but management frames these as necessary for durable share capture. The company’s cash runway is expected to last through break-even, with no additional equity financing anticipated. The focus now shifts to sustaining refill rates, driving international uptake, and leveraging real-world evidence to support further adoption and label expansion.
Executive Commentary
"Third quarter marks a true inflection point for our business. As you can see on slide three, U.S. net product revenue for NEFI grew again quarter over quarter, reaching $31.3 million in Q3, representing a 2.5-fold increase from the prior quarter and exceeding consensus expectations... These results show that our multifaceted commercial strategy is delivering results."
Richard Lowenthal, Co-Founder, President, and CEO
"Our DTC campaign is also delivering meaningful engagement... Consumer awareness has climbed from 20% pre-campaign to 56% as of September. An intent to get NEFI remains high. Approximately 80% of surveyed patients say they are very likely or extremely likely to ask their healthcare provider about NEFI after learning about it."
Eric Paris, Chief Commercial Officer
Strategic Positioning
1. NEFI’s Differentiation and Market Expansion
NEFI’s needle-free nasal delivery addresses key barriers to epinephrine adoption, such as needle anxiety and device complexity, which have historically limited adherence and refill rates. The company’s real-world evidence shows that NEFI achieves efficacy on par with injectors, with 9 out of 10 anaphylaxis cases resolved with a single dose. This positions NEFI not just as a share gainer but as a market expander, reaching lapsed and untreated patients who previously avoided therapy.
2. Direct-to-Consumer and Virtual Prescriber Model
The Get NEFI on Us program leverages a virtual prescriber system to streamline access, reduce administrative friction, and enable immediate switching from injectors. This model is designed to flatten the seasonality curve, extend growth beyond back-to-school months, and sustain adoption year-round. Early feedback suggests significant patient and provider willingness to use virtual prescribing, with refill management simplified through digital channels.
3. International Growth and Label Expansion
Global launches in Germany, Japan, Canada, and China are staged for 2026, with early German data showing three times faster market share capture than the U.S. where administrative barriers are lower. The Phase IIb urticaria trial, targeting a 2 million patient U.S. market, could unlock a substantial new indication, with preliminary physician research supporting broad adoption if approved.
4. Capital Allocation and Balance Sheet Strength
Securing a $250 million term loan facility with favorable terms and no equity dilution, ARS reinforces its ability to fund commercial expansion, DTC campaigns, and clinical programs. The company’s cash position is expected to support operations through break-even, aligning investor and management interests for long-term value creation.
Key Considerations
ARS Pharmaceuticals’ Q3 marks a transition from early launch to scaled commercial execution, with strategic investments aimed at maximizing NEFI’s adoption and revenue durability. Investors should weigh both the rapid uptake and the operational levers designed to sustain growth into 2026 and beyond.
Key Considerations:
- Refill Rate and Adherence Tailwind: NEFI’s refill intent (95% vs. 30% for injectors) could structurally expand the prescription market if sustained.
- Administrative Friction Remains a U.S. Drag: Physician and patient burden, especially during peak season, remains a headwind but is being addressed via virtual prescriber programs.
- International Launch Execution: Early German momentum and upcoming launches in Japan, Canada, and China are critical to multi-year revenue growth.
- Label Expansion Opportunity: Success in the urticaria trial could further differentiate NEFI and drive share in a new, large patient segment.
- Gross-to-Net Dynamics: Continued improvement in gross-to-net retention and payer coverage will be necessary to translate top-line growth into profitability.
Risks
Key risks include potential slowdowns in refill rates if initial intent does not translate to behavior, ongoing administrative and reimbursement barriers in the U.S., and execution risk around international launches and label expansion trials. Competitive response from incumbent injector brands and pricing pressure could also impact gross-to-net realization. Investors should monitor for any signs of DTC campaign fatigue or regulatory delays in new markets.
Forward Outlook
For Q4 2025, ARS Pharmaceuticals expects:
- A seasonal decline in U.S. sales, in line with the historical one-third drop in the epinephrine market during the holidays.
- Resumption of quarter-over-quarter growth in 2026 as both NEFI market share and overall script volumes rise.
For full-year 2025, management reiterated its focus on:
- Sustaining NEFI’s U.S. market share growth and driving refill adoption.
- Executing international launches and advancing the urticaria label expansion trial.
Management highlighted several factors that will shape the next quarters:
- Continued investment in DTC and virtual prescriber access to flatten seasonality.
- Expansion of payer coverage and improved gross-to-net retention.
Takeaways
ARS Pharmaceuticals has demonstrated that NEFI can accelerate market share capture and expand the addressable market via innovation in both product and channel strategy.
- U.S. Launch Momentum: Rapid adoption and strong refill signals point to durable share gains, but execution on refill conversion and payer coverage will be decisive.
- Global and Pipeline Catalysts: International launches and urticaria label expansion represent multi-year growth levers, but require flawless execution and regulatory success.
- Focus for Investors: Watch refill rates, international uptake, and evidence of sustained gross-to-net improvement as key signals of long-term value realization.
Conclusion
NEFI’s U.S. ramp and global expansion plans have positioned ARS Pharmaceuticals for a new phase of growth, but the next leg will depend on converting refill intent into recurring revenue and scaling internationally. Investors should track execution on DTC, access, and clinical milestones as the business moves toward profitability and broader market leadership.
Industry Read-Through
NEFI’s success highlights the potential for patient-centric, needle-free drug delivery to disrupt legacy markets, especially where adherence and device complexity have limited growth. The impact of DTC and virtual care models in specialty pharma is increasingly clear, with administrative simplification driving both share gains and market expansion. Other pharmaceutical companies with therapies limited by delivery method or patient burden may look to ARS’s playbook as a template for accelerating adoption and expanding addressable markets. The competitive response from incumbent brands and payers will be a key industry dynamic to watch in 2026.