ARS Pharmaceuticals

What ARS Pharmaceuticals does

ARS Pharmaceuticals (Nasdaq: SPRY) is a publicly traded specialty pharmaceutical company founded in 2015 and headquartered in San Diego, California. The company develops and commercializes neffy, the first and only FDA-approved needle-free intranasal epinephrine spray for emergency treatment of Type I allergic reactions including anaphylaxis. Neffy's proprietary technology is built around Intravail (dodecyl-maltoside), a patented absorption agent that enables injection-like pharmacokinetics through nasal administration, paired with a delivery device reporting 99.999% dose-delivery reliability. The product targets approximately 40 million people in the United States with severe allergies, of whom only about 3 million currently hold an epinephrine prescription and an estimated 80-90% do not carry or administer their device as indicated due to needle aversion and device inconvenience.

The revenue model combines direct U.S. commercial sales through wholesale distributors (McKesson, Cardinal Health, Cencora, Anda) and specialty pharmacy channels with international licensing partnerships (ALK-Abelló for Canada, Pediatrix Therapeutics for China). For the full year 2025, ARS reported total revenue of $84.3 million, of which $72.2 million was U.S. neffy net product sales; Q1 2026 revenue reached $22.7 million, a 124% year-over-year increase. Patient access is supported by the neffyConnect co-pay and patient-assistance program and a direct cash-pay channel that became a focal point after PBM coverage was denied. Commercial operations are built around a 148-person specialty sales force (targeting 150 in Q2 2026) directed at allergists, emergency physicians, and pediatricians, supplemented by direct-to-consumer, celebrity (Drew Brees), medical-conference, and community (neffyInSchools) initiatives.

Capital structure reflects a November 2022 merger with Silverback Therapeutics that delivered over $280 million in cash and securities and created the public Nasdaq listing, an August 2021 $55 million Series D led by SR One with participation from RA Capital and Deerfield, and an October 2025 $250 million loan facility to fund commercialization. The company holds regulatory approvals for neffy in the United States, Canada, China (NMPA, December 2025), and the European Union (EURneffy 1 mg and 2 mg), and is advancing a Phase 2b pipeline program for chronic spontaneous urticaria with interim data expected in Q4 2026.

Name

ARS Pharmaceuticals

Legal name

ARS Pharmaceuticals, Inc.

Website

https://ars-pharma.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

ARS Pharmaceuticals (Nasdaq: SPRY) is a specialty pharmaceutical company that develops and commercializes neffy, the first FDA-approved needle-free intranasal epinephrine spray for emergency treatment of severe allergic reactions, serving roughly 40 million Americans with Type I allergies.

Ownership category

akta.pro rank

Product category

Epinephrine Nasal Spray (Allergy Therapeutics)

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Nasal Drug Delivery Devices (Sprays/Powder Devices) (HLAHAIAK)

akta.pro secondary industry

Needle-Free Injection Systems (Jet Injectors/Microneedle Patches) (HLAHAIAD)

Keywords

• Epinephrine nasal spray
• Allergy therapeutics
• Anaphylaxis treatment
• Needle-free drug delivery
• Intranasal pharmaceuticals

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Personnel, Marketing or Sales, Technology or R&D, Operations, Supply Chain

Revenue model

1. Neffy product sales: Commercial revenue from neffy U.S. net product sales following FDA approval. Q1 2026 revenue of $22.7M including $17.5M in neffy net product revenue, up 124% year-over-year. Full year 2025 revenue of $84.3M with neffy generating $72.2M in U.S. net product revenue.
2. International licensing and milestones: Upfront payments, regulatory milestones, and sales milestones from international partners. Received $155M in upfront and milestone payments from ALK-Abelló for Canada licensing with potential for up to $310M in additional regulatory and sales milestones. $4M regulatory milestone from China approval with potential for up to $80M plus tiered royalties.

Pricing tiers

Go-to-market motion3 records

Distribution channels7 records

Marketing channels7 records

Core offering

ARS Pharmaceuticals manufactures and commercializes neffy, the first and only FDA-approved needle-free intranasal epinephrine spray for emergency treatment of Type I severe allergic reactions including anaphylaxis in adults and children weighing at least 33 lbs. Available in 1mg and 2mg doses, neffy uses the proprietary Intravail (dodecyl-maltoside) absorption agent to deliver epinephrine with injection-like pharmacokinetics through nasal administration, addressing the gap where 80-90% of prescribed patients do not carry or use auto-injectors due to needle fear. The company also supports patient access through co-pay programs (neffyConnect) and a K-12 schools donation program (neffyInSchools).

Product overview

ARS Pharmaceuticals commercializes neffy (epinephrine nasal spray), the first FDA-approved needle-free epinephrine product for emergency treatment of severe allergic reactions including anaphylaxis. The portfolio consists of the core neffy product available in 1mg and 2mg doses, supported by the neffyConnect patient assistance program for access and affordability, and the neffyInSchools community initiative distributing free product to U.S. schools. The company is also advancing its intranasal epinephrine technology into chronic spontaneous urticaria through a Phase 2b pipeline program.

Differentiator

Problem solved

Functional benefit

Brands

• neffyConnect: Patient support and financial assistance program for neffy, providing medication fulfillment, financial support, insurance navigation, and access barriers assistance
• neffyinSchools
• neffy
• EURneffy

Products and services

• neffy (epinephrine nasal spray) FDA-approved needle-free intranasal epinephrine spray for emergency treatment of Type I severe allergic reactions including anaphylaxis in adults and children weighing 33 lbs or greater. Available in 1mg and 2mg doses, it uses the proprietary Intravail (dodecyl-maltoside) absorption agent to deliver injection-like pharmacokinetics via nasal administration through a device with a 99.999% dose-delivery track record. It targets the approximately 40 million Americans with severe allergies, of whom only 3 million currently hold an epinephrine prescription, addressing the gap where 80-90% of prescribed patients fail to carry or administer auto-injectors due to needle fear.

Quantifiable outcome

• 124% year-over-year revenue growth in Q1 2026
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Three partnerships are on record, tiered minor and core.

• Drew BreesminorGTM or Marketing Partner · 4 June 2026Celebrity collaboration to raise awareness about severe food allergies and epinephrine treatment options. Brees, who has food allergies himself, participates in education initiatives emphasizing preparedness and emergency response. Campaign aims to improve timely treatment for allergic reactions.
• ALK-Abelló A/ScoreOEM/ Whitelabel/ Licensing Partner · 1 November 2024Exclusive licensing agreement for neffy commercialization in Canada. ARS Pharma received $155 million in upfront and milestone payments and is eligible for up to $310 million in additional regulatory and sales milestones. Health Canada approved neffy on April 15, 2026, with expected launch summer 2026, potentially benefiting over 2.5 million Canadians with severe allergies.
• Pediatrix TherapeuticscoreOEM/ Whitelabel/ Licensing PartnerLicensing agreement for neffy commercialization in China. China's NMPA approved neffy 2mg on December 29, 2025. ARS Pharma received $4 million regulatory milestone payment with potential for up to $80 million plus tiered royalties in additional milestones. Product expected spring 2026 in China.

Scale indicators16 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Viatris: Viatris markets EpiPen, the dominant epinephrine auto-injector and ARS Pharma's primary direct competitor in emergency anaphylaxis treatment. Comparable in therapeutic area, prescriber base, and patient population, though Viatris operates broadly across generics and branded pharma.
• Emergent BioSolutions: Emergent BioSolutions operates in the emergency countermeasure space with epinephrine-related products. ARS's CCO previously led commercial initiatives there. Comparable in addressing acute allergic and emergency-response therapeutics.
• Teva Pharmaceutical: Teva markets authorized generic epinephrine auto-injectors that compete with EpiPen and by extension neffy. Comparable as a high-volume manufacturer of epinephrine injectables supplying retail and institutional pharmacy channels.
• Seqirus (CSL): Seqirus, a CSL subsidiary, distributes Auvi-Q in the U.S. and operates broadly in vaccines and specialty therapeutics. Comparable as a distributor and channel partner for emergency epinephrine products to allergy specialists and schools.

Direct peers

• Kaleo (Auvi-Q): Kaleo manufactures Auvi-Q, a competing compact epinephrine auto-injector with voice-prompt instructions, directly competing with neffy for allergist prescriptions and school stocking contracts in the U.S. emergency epinephrine market.
• Amphastar Pharmaceuticals: Amphastar manufactures specialty injectable pharmaceuticals including epinephrine and other emergency-use injectables. It is comparable as a specialty pharma with similar injectable/epinephrine product focus and FDA-approved manufacturing footprint.
• Dynavax Technologies: Dynavax is a commercial-stage biopharma specializing in allergy-adjacent vaccines (HEPLISAV-B). ARS's new President Donn Casale was CCO there. Comparable as a public, U.S.-based commercial biopharma scaling a single-category product to specialty prescribers.
• Adapt Pharma / NARCAN: Adapted into Emergent BioSolutions, NARCAN nasal spray pioneered needle-free community-use emergency therapeutics. ARS's CCO previously led NARCAN's commercial launch, making it a directly comparable needle-free emergency medication franchise targeting lay users.

Regional players

• ALK-Abelló: ALK-Abelló is ARS's Canadian licensing partner for neffy and a global leader in allergy immunotherapy. Comparable in allergy-focused therapeutics and serves a similar allergist channel, though its primary franchise is sublingual immunotherapy rather than emergency epinephrine.

Emerging players

• PharmaTher Holdings: PharmaTher is developing novel formulations of epinephrine and other emergency-use drugs. Comparable as a small emerging player pursuing differentiated delivery formats in the epinephrine space that may overlap with ARS's intranasal platform strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks4 records

Key highlights7 records

Customer concentration

• Xx.com/ars_pharma
• LinkedInlinkedin.com/company/arspharmaceuticals

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries3 records

Funding overview

Funding rounds3 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ARS Pharmaceuticals