ARS Pharmaceuticals (SPRY -5.04%), the biopharma company developing needle-free allergy treatments, released its second-quarter 2025 results on August 13, 2025. The most significant takeaway from the release was a major GAAP revenue beat, as total GAAP revenue climbed to $15.7 million versus the $13.8 million analyst expectation (GAAP). neffy, its epinephrine nasal spray, drove this revenue, with prescription volume and market coverage both expanding sharply. On the other hand, Elevated spending, especially on sales and marketing, led to a net loss per share of $(0.46) (GAAP). The quarter was defined by accelerating product momentum offset by persistent, high operating costs as commercialization activities scaled up.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.46) | $(0.46) | $(0.13) | N/A |
| Revenue (GAAP) | $15.7 million | $13.8 million | $0.5 million | 3,040% |
| neffy U.S. Net Product Revenue | $12.8 million | $0 | N/M | |
| R&D Expenses | $4.0 million | $6.9 million | (42%) | |
| Selling, General and Administrative Expenses | $54.3 million | $8.9 million | 507% |
Source: ARS Pharmaceuticals. Note: Analyst estimates provided by FactSet.
Business Overview and Growth Focus
ARS Pharmaceuticals specializes in developing and commercializing treatments for severe allergic reactions. Its flagship product, neffy, is a needle-free epinephrine nasal spray approved for emergency use in patients with type I allergic reactions, including anaphylaxis. The U.S. epinephrine market has historically relied on injectors, like EpiPen, which many patients find difficult or intimidating to use.
The company's recent focus centers on scaling neffy’s adoption in the United States and expanding into international markets. Success depends on growing prescriber and patient adoption, securing commercial insurance coverage, differentiating from existing treatments, and gaining regulatory approvals. Key factors include neffy’s unique delivery and acceptance among healthcare providers, ongoing payer negotiations, and a robust commercialization plan expected to drive awareness and prescriptions.
Quarterly Highlights: Financial and Commercial Results
During the quarter, ARS Pharmaceuticals delivered a major leap in its top line, reporting GAAP revenue of $15.7 million. Total GAAP revenue grew to $15.7 million from $0.5 million in Q2 2024. This figure outpaced analyst projections by 14.0% (GAAP). Most revenue came from U.S. neffy sales ($12.8 million) (GAAP), with additional boosts from international milestone and supply agreements.
The sharp rise in revenue was powered by prescription growth and payor access. Weekly two-pack prescription volumes grew by about 180% from Q1 to Q2, This volume growth occurred before the rollout of the company's national DTC campaign. Commercial insurance coverage for neffy expanded rapidly, reaching 93% of commercial lives, with more than half of coverage (57%) requiring no prior authorization as of Q1. Streamlined access has helped ease barriers for prescribers and patients.
The company also recognized international expansion milestones, including $2.6 million in milestone revenue from ALK-Abelló A/S related to the launch of EURneffy® in Germany. neffy launched in Germany, generating $2.6 million in milestone revenue and received regulatory approval in the United Kingdom, with launches planned in several key markets before the end of fiscal 2025 or early fiscal 2026. ARS Pharmaceuticals noted strong traction in healthcare provider programs, surpassing 9,700 U.S. prescribers and robust participation among allergists and schools.
However, the cost of this rapid expansion was evident. Selling, general, and administrative expenses (GAAP) reached $54.3 million, compared to $8.9 million in Q2 2024. -- as the company invested heavily in its promotional campaign and sales force. The higher operating costs drove the net loss to $44.9 million (GAAP). The company held $240.1 million in cash and short-term investments as of quarter end, supporting ongoing investment and runway claims for at least three years. No dividends were declared.
Product, Market, and Pipeline Updates
neffy stands out as the only approved needle-free epinephrine treatment currently available in the U.S. Unlike traditional auto-injectors, neffy is administered via nasal spray, potentially addressing the hesitation some patients have about using self-injectable medications in urgent situations. It targets both adults and children with severe allergies, with newly available dosing for pediatric populations debuting this spring.
Adoption of neffy has accelerated along several dimensions. Over 2,800 allergists and 3,200 schools have engaged in company-run programs aimed at education and sampling. ARS Pharmaceuticals has also emphasized its direct partnerships and collaborations outside the United States, leveraging relationships with global pharmaceutical companies for commercialization in Europe and Asia.
The quarter also saw the launch of the first DTC marketing campaign for neffy, which raised consumer brand awareness from about 20% before the campaign to 49% by late July. The campaign targeted families ahead of back-to-school season, aiming to increase future prescription rates as awareness improves. Gross-to-net revenue retention, a measure of realized sales after discounts, settled at 52% -- a steady-state expectation according to management.
Beyond allergic reactions, ARS Pharmaceuticals expanded its development pipeline. The company initiated a phase 2b clinical trial for urticaria (hives) in June, aiming to explore additional indications for its intranasal epinephrine approach. Approvals or launches in Canada, Japan, Australia, and China are targeted between late 2025 and early 2026, continuing the global expansion theme.
Looking Ahead: Guidance and Investor Watchpoints
Management did not provide formal financial guidance for future quarters or the full fiscal year. It reiterated that increased script volumes and higher seasonal demand in the second half should support additional growth. The company plans further marketing and prescriber-targeted programs but did not update explicit sales, revenue, or profitability targets for fiscal 2025.
ARS Pharmaceuticals remains well capitalized, with $240.1 million in cash, cash equivalents, and short-term investments as of June 30. As the commercialization plan builds momentum, investors may focus on Key areas of investor focus include prescription growth, payer coverage improvements, and market share gains. SPRY does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
