ARS Pharmaceuticals Delivers Robust 2025 Financial Results and Updates on neffy® Commercialization

San Diego, March 9, 2026 – ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company focused on empowering at-risk patients and their caregivers to manage allergic reactions and prevent anaphylaxis, has announced its financial results for the fourth quarter and full year 2025. The company also provided significant updates on the commercial rollout of neffy®, its novel, needle-free epinephrine nasal spray.

Key Highlights for Investors

• neffy® U.S. Net Product Revenue Surges to \$72.2 Million in First Full Year
• Total 2025 Revenue: \$84.3 million, driven by U.S. neffy sales, collaboration, and supply agreements
• Strong Cash Position: \$245 million in cash, cash equivalents, and short-term investments as of December 31, 2025
• Ongoing Commercial Expansion: neffy now approved by the FDA, European Commission, and in China and Australia
• Active Payer Engagement: Progress with insurers, with a focus on securing unrestricted access in 2026
• Direct-to-Consumer (DTC) Marketing: Substantial investment driving awareness and adoption; new campaign launched January 2026
• Sales Force Expansion: Increasing from 106 to 150 reps in Q2 2026, funded through reallocation with no anticipated 2026 SG&A increase
• Phase 2b Trial in Chronic Spontaneous Urticaria (CSU): Data expected mid-2026, supporting pipeline expansion
• Net Loss: \$171.3 million for 2025, or \$1.74 per share
• Strong Healthcare Provider Adoption: Over 22,500 HCPs have prescribed neffy, with 50% being repeat prescribers
• School Penetration: Over 9,000 schools enrolled in the neffy inSchools program
• Upcoming Catalysts: Canadian approval decision expected Q2 2026; pipeline data in H2 2026

Financial Results in Detail

Q4 and Full-Year 2025 Financials

• Fourth Quarter 2025 Revenue: \$28.1 million
  • \$20.3 million from U.S. neffy sales
  • \$6.9 million collaboration revenue (international partners)
  • \$0.9 million supply revenue
• Full-Year 2025 Revenue: \$84.3 million
  • \$72.2 million from U.S. neffy sales
  • \$9.7 million collaboration revenue
  • \$2.4 million supply agreements
• R&D Expenses: \$13.2 million for 2025, focused on development, trials, and personnel
• SG&A Expenses: \$230.1 million for 2025, reflecting heightened investment in DTC marketing and commercialization efforts
• Net Loss: \$171.3 million for 2025 (\$1.74 per share)
• Cash, Cash Equivalents, and Short-Term Investments: \$245 million at year-end, with 99.3 million shares outstanding
• Company Guidance: Cash position expected to fund operations through anticipated cash-flow break-even

Commercial Launch Progress & Strategic Initiatives

Payor and Market Access

• Ongoing payer discussions to secure unrestricted formulary access for neffy
• Eligible commercially insured patients can access neffy with a \$0 co-pay
• Eight state Medicaid plans now cover neffy without prior authorization; more expected in 2026
• Targeting gross-to-net retention of ~50% as market access expands

Marketing & Sales Execution

• Updated DTC TV campaign launched January 2026 to drive awareness and adoption
• Sales force to expand from 106 to 150 reps in Q2 2026, funded through reallocation (not increasing SG&A)
• Over 22,500 HCPs have prescribed neffy, with repeat prescribers at 50%
• “Get neffy on Us” campaign reduces barriers via free virtual provider and \$0 co-pay; 10% of prescriptions now through getneffy.com
• Real-world evidence from the neffy Experience Program (published Dec 2025) shows ~90% of patients effectively treated with a single dose, outcomes comparable to injection

School and Community Penetration

• neffy inSchools program: Over 9,000 schools now receive neffy for emergency use at no cost

Clinical Pipeline Update

• Ongoing U.S. Phase IV post-marketing study in anaphylaxis (600 treatment events under medical supervision)
• Phase 2b trial in chronic spontaneous urticaria (CSU) enrolling in the U.S. and Europe; interim data expected H2 2026

Global Expansion Milestones

• Europe: In January 2026, European Medicines Agency’s CHMP adopted a positive opinion for EUR neffy® 1 mg for children 4+ years, 15–30 kg
• China: December 2025 approval for neffy 2 mg in adults and children (≥30 kg); \$4M milestone payment received from Pediatrix Therapeutics
• Australia: December 2025 approval for neffy 2 mg and 1 mg in adults and children aged 4+ years and weighing ≥15 kg
• Canada: Regulatory decision expected Q2 2026 (collaboration with ALK)

Strategic Outlook and Shareholder Considerations

• Renewal Opportunity: Initial neffy prescriptions expected to renew in 2026 as product expires, supporting accelerating market share
• Continued Investment: Company to maintain elevated SG&A/DTC spending in 2026 to drive adoption
• Global Regulatory Catalysts: Imminent Canadian decision, further international launches possible
• Pipeline Progress: Advancement in new indications (CSU) could expand addressable market

Risks & Forward-Looking Statements

• Maintaining regulatory approvals, realizing DTC ROI, managing personnel costs, and payer access remain key risks
• Market acceptance, competition with injectable epinephrine, and clinical pipeline outcomes could materially impact performance and valuation
• Investors are encouraged to review full risk factors in the company’s filings

Conference Call Details

Management will host a call and webcast on March 9, 2026, at 5:30 a.m. PT / 8:30 a.m. ET. Slides and replay will be available on the company’s website.

Product and Safety Information

• neffy is a nasal spray for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children aged 4+ years and ≥33 lbs (U.S.); in the EU for ≥30 kg
• Patients are advised to always carry two neffy nasal sprays
• Common side effects: nasal discomfort, headache, throat irritation, congestion, excitement, nosebleed, pain, sneezing, runny/dry nose/throat, tingling, fatigue, dizziness, nausea, vomiting
• Not all side effects listed; see full prescribing information

Conclusion

With strong revenue growth from neffy, expanding payer and school access, a robust cash position, and international approvals, ARS Pharmaceuticals is positioned for further market share gains and potential pipeline expansion in 2026. The outcome of payer negotiations, DTC marketing effectiveness, and regulatory reviews in Canada and other territories could have a significant impact on future share value.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially. Investors should review company filings and consult with financial advisors before making investment decisions.

View ARS Pharmaceuticals, Inc. Historical chart here