ARS Pharmaceuticals
Maker of the first FDA-approved needle-free nasal spray for severe allergic reactions.
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Profile
Sells neffy, a needle-free nasal spray version of epinephrine for emergency treatment of severe allergic reactions, as its only approved product. U.S. sales are booked directly, while partners commercialize it across Europe, Canada, the U.K., and Asia-Pacific for milestone payments and royalties.
neffy is a nasal spray delivering epinephrine without a needle, approved as the first and only needle-free rescue treatment for Type I allergic reactions including anaphylaxis. It reached the U.S. market in late 2024, following a prior round of additional FDA-requested testing, and a lower-dose pediatric version followed in 2025.
Commercial rights stay with the company in the U.S., where revenue is booked directly; every other region runs through licensed partners covering Europe, Canada, the U.K., Japan, China, and Australia and New Zealand, generating milestone payments and royalties rather than direct sales.
neffy is the company's only approved product, with a related nasal-epinephrine candidate for chronic hives in mid-stage testing. Continued growth depends on regulatory clearances for label and geographic expansion, and the company manufactures supply for its licensing partners as well as itself.
Company facts
Key statistics
Year to date −48.8% · Average volume (30d) 2.3M
Analysts
Ratings
Target range
Latest analyst notes
| Date | Firm | Action | Prior target | Target |
|---|---|---|---|---|
| Apr 9, 2026 | Northland Securities | Target | $25 | |
| Mar 10, 2026 | Leerink Partners | Target | $18 | $26 |
| Nov 4, 2025 | Roth Capital | Target | $30 | |
| Sep 26, 2025 | Raymond James | Target | $22 | $32 |
Earnings
EPS
Revenue
History
| Report date | EPS est | EPS | Surprise | Revenue est | Revenue | Surprise | Next session |
|---|---|---|---|---|---|---|---|
| Aug 13, 2026Q2 FY26 | −$0.48 | −$0.63 | −31.9% | $31.3M | $33.7M | +7.5% | −7.38% |
| May 15, 2026Q1 FY26 | −$0.53 | −$0.61 | −15.1% | $22.2M | $22.7M | +2.2% | −1.75% |
| Mar 9, 2026Q4 FY25 | −$0.42 | −$0.42 | 0.0% | $25.6M | $28.1M | +9.7% | −2.10% |
| Nov 10, 2025Q3 FY25 | −$0.45 | −$0.52 | −15.6% | $25.6M | $32.5M | +27.0% | −1.24% |
Financial highlights
| 12 quarters | Q1 FY25 | Q2 FY25 | Q3 FY25 | Q4 FY25 | Q1 FY26 | Q2 FY26 | |
|---|---|---|---|---|---|---|---|
| Revenue | $8.0M | $15.7M | $32.5M | $28.1M | $22.7M | $33.7M | |
| Gross profit | $3.9M | $10.7M | $24.3M | $24.9M | $16.4M | $20.8M | |
| Operating income | −$37.2M | −$47.6M | −$53.2M | −$41.5M | −$60.1M | −$61.5M | |
| Net income | −$33.9M | −$44.9M | −$51.2M | −$41.3M | −$60.6M | −$62.3M | |
| Diluted EPS | −$0.35 | −$0.46 | −$0.52 | −$0.42 | −$0.61 | −$0.63 | |
| Gross margin | 49.3% | 68.3% | 74.8% | 88.6% | 72.3% | 61.8% | |
| Operating margin | -466.3% | -302.9% | -163.7% | -147.6% | -265.2% | -182.6% |
Fiscal years (4-quarter sums)FY21 $5.5M · FY22 $1.3M · FY23 $30.0K · FY24 $89.1M · FY25 $84.3M
Revenue by product · Q2 FY26
Revenue by geography · Q2 FY26
Balance sheet, Jun 30, 2026Cash & short-term investments $143.8M · Total debt $171.6M · Total assets $249.5M · Shareholders' equity $12.5M
Dividends
No dividends on record.
Ownership
Institutions and insiders are filed separately and overlap, so together they can pass the whole company. No split is drawn from them.
Shares outstanding 99.30M · Float 64.50M · 65.0% free float
Top shareholders13F · 13D/G · Form 4
| Holder | Shares | % outstanding | Form | Filed |
|---|---|---|---|---|
| Ra Capital Management, L.P. | 10.86M | 10.94% | 13F | Aug 14, 2026 |
| Rubric Capital Management LP | 8.54M | 8.60% | 13F | Aug 14, 2026 |
| Orbimed Advisors LLC | 8.29M | 8.35% | 13F | Aug 14, 2026 |
| Deerfield Management Company, L.P. (Series C) | 7.50M | 7.56% | 13F | Aug 14, 2026 |
| Richard E. Lowenthal · director, 10 percent owner, officer: PRESIDENT AND CEO | 5.52M | 5.56% | Form 4 | Aug 22, 2025 |
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| Jun 12, 2026 | Alexander A. Fitzpatrick | officer: Chief Legal Officer | −3,355 | $10.00 |
| Jun 12, 2026 | Eric Karas | officer: Chief Commercial Officer | −25,000 | $10.00 |
| Nov 12, 2025 | Justin Chakma | officer: Chief Business Officer | −166,380 | $8.87 |
| Nov 13, 2025 | Brian Dorsey | officer: Chief Operating Officer | −21,828 | $8.71 |
Peers
- Viatris
Market-leading injectable epinephrine autoinjector (EpiPen)
- Teva (ADR)
Largest generic drugmaker; sells authorized generic EpiPen injectable
- Amphastar Pharmaceuticals
Injectable/inhalation/intranasal generics maker with an epinephrine product line
- Aquestive Therapeutics
Pre-approval sublingual-film epinephrine, direct device-free substitute threat
- Amneal Pharmaceuticals
Delaware-based generics maker selling a generic epinephrine autoinjector
CompareAfter-hours close
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| ARS Pharmaceuticals | $5.99 | +1.78% | $584.9M | — | — | 5.0 | +114.2% |
| Viatris | $16.30 | −0.23% | $19.03B | — | 6.4 | 1.3 | +4.9% |
| Teva (ADR) | $36.30 | −0.36% | $42.44B | 60.7 | 12.9 | 2.5 | −0.8% |
| Amphastar Pharmaceuticals | $22.01 | 0.00% | $970.5M | 13.0 | 6.9 | 1.3 | +5.4% |
| Aquestive Therapeutics | $5.02 | 0.00% | $629.8M | — | — | 11.6 | +38.2% |
| Amneal Pharmaceuticals | $17.54 | 0.00% | $5.60B | 36.0 | 16.9 | 1.8 | +9.9% |
| Median | 36.0 | 9.9 | 1.8 | +5.4% |