ARS Pharms Stock Price, News & Analysis

ARS Pharmaceuticals (NASDAQ: SPRY) reported Q1 2025 financial results and progress in the U.S. launch of neffy®, their FDA-approved needle-free epinephrine nasal spray. The company achieved $7.8 million in neffy U.S. net product revenue. Key highlights include: nationwide availability of neffy 1mg for children aged 4+ and 2mg for adults, co-promotion agreement with ALK-Abelló reaching nearly 20,000 healthcare providers, and over 5,000 prescribing physicians to date. Financial results show $275.7 million in cash reserves with runway for 3+ years, though the company reported a net loss of $33.9 million. Commercial progress includes 57% commercial coverage, with United Healthcare added April 1st, and over 1,000 schools enrolled in the neffyinSchools program. The company plans to launch a comprehensive DTC marketing campaign and expects regulatory decisions in multiple international markets throughout 2025-2026.

ARS Pharmaceuticals (NASDAQ: SPRY) has announced the U.S. availability of neffy® 1 mg, their FDA-approved nasal spray epinephrine for Type I allergic reactions and anaphylaxis in children aged 4+ years weighing 15-30 kg. The needle-free design eliminates the risk of accidental injections, which affects ~3,500 cases annually. Key features include:

- 100% successful dosing rate in human factor studies - 24-month shelf life with temperature tolerance up to 122°F - Available at $199 for two doses (GoodRx price) - Eligible commercially insured patients pay as little as $25 - Partnership progress with major insurers including United Healthcare and Express Scripts

The company is implementing comprehensive support programs, including financial assistance and a Patient Assistance Program for eligible uninsured patients. The neffyinSchools program will provide the medication to participating eligible schools.

ARS Pharmaceuticals (NASDAQ: SPRY), a biopharmaceutical company focused on developing solutions for anaphylaxis protection, has scheduled a conference call and webcast for Wednesday, May 14, 2025, at 5:30 a.m. PT / 8:30 a.m. ET. The event will cover the company's first quarter 2025 financial results and business highlights.

Participants can obtain dial-in information by registering for the event. The webcast and presentation slides will be accessible through the Events & Presentations page in the Investors & Media section of the company's website. A replay will remain available for 30 days after the event.

ARS Pharmaceuticals (NASDAQ: SPRY) has announced a co-promotion agreement with ALK-Abelló A/S to expand the reach of neffy® (epinephrine nasal spray) to additional U.S. pediatricians. This four-year partnership follows their previous licensing deal which provided ARS Pharma with $145 million upfront. The agreement will expand ARS Pharma's promotional reach to nearly 20,000 healthcare providers, targeting pediatricians who represent about 55% of all community-use epinephrine prescriptions in the U.S. Under the agreement, ARS Pharma will maintain U.S. revenue recognition and commercialization responsibilities, while ALK will be eligible for performance-based payments based on market share thresholds. The company expects operating expenses to increase by $3 million per quarter starting Q3 2025.

ARS Pharmaceuticals (SPRY) reported strong financial results for Q4 and full year 2024, with total revenue of $89.1 million, including $7.3 million from neffy® sales since its September 2024 launch. The company achieved net income of $49.9 million in Q4 and $8.0 million for the full year.

Key highlights include FDA approval of neffy 1 mg for children aged four and older weighing 15-30 kg, expanding market reach to ~2 million younger children. The company secured favorable coverage decisions from major insurers and is on track for >60% commercial lives coverage by Q1 2025.

With $314.0 million in cash and investments as of December 31, 2024, ARS maintains a three-year operating runway. The company received a $145 million upfront payment from ALK-Abelló partnership, with $73.5 million recognized as Q4 revenue.

ARS Pharmaceuticals (NASDAQ: SPRY) has received FDA approval for neffy® 1 mg, the first needle-free epinephrine nasal spray for Type I Allergic Reactions, including anaphylaxis, in children aged 4+ years weighing 15-30 kg. The approval marks the first major innovation in epinephrine delivery for this patient population in over 35 years.

The approval is supported by extensive clinical trials showing pharmacokinetic and pharmacodynamic responses comparable to injectable epinephrine. Human factor studies demonstrated effective use by children as young as 10 and untrained caregivers. The device maintains stability at room temperature for 24 months.

neffy 1 mg will be available in the US by May 2025, with most commercially insured patients paying $25 or less for two devices. A cash price of $199 for two doses is available through BlinkRx, with additional support through the neffyConnect program and Patient Assistance Program for eligible individuals.

ARS Pharmaceuticals (SPRY), a biopharmaceutical company focused on anaphylaxis prevention, has scheduled its fourth quarter and full year 2024 financial results conference call for March 20, 2025, at 8:30 a.m. ET.

The company will also participate in upcoming investor events including:

• Leerink Partners Global Healthcare Conference with a fireside chat on March 10, 2025
• 37th Annual Roth Conference with investor meetings on March 16-18, 2025

A webcast replay will be available for 30 days following the earnings call on the company's website under the Events & Presentations page.

ARS Pharmaceuticals (NASDAQ: SPRY) announced that OptumRx, Cigna Healthcare, and Navitus Health Systems have added neffy® (epinephrine nasal spray) to their National Formularies. This expansion, occurring approximately five months after launch, provides access to half of all patients managing Type 1 allergic reactions, with coverage now available through 30 formulary platforms.

Patients insured by these providers will have access to neffy at the lowest branded copay without prior authorizations or step therapies. With ARS Pharma copay assistance, qualified patients can obtain neffy for $25. The company is currently working with UnitedHealthcare to add neffy to their formulary.

neffy 2 mg, the first FDA-approved epinephrine nasal spray, is designed for adults and children weighing ≥30 kg. A supplemental NDA for neffy 1 mg, intended for children over four years weighing 15-30 kg, has a PDUFA date of March 6, 2025, with expected availability by May 2025.

ARS Pharmaceuticals (NASDAQ: SPRY) announced nine presentations featuring data on neffy® (epinephrine nasal spray) at the 2025 AAAAI Annual Scientific Meeting. Key highlights include an oral presentation showing neffy's superior efficacy in Japanese patients during food challenges, with lower symptom scores within 10 minutes compared to traditional treatments.

The presentations will showcase comprehensive clinical research data, including pharmacokinetics and pharmacodynamics studies in Chinese subjects, demonstrating neffy's comparable efficacy and safety to intramuscular injection under various conditions. The studies confirm neffy's effectiveness in children four years or older weighing more than 15 kilograms.

neffy is the first and only FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in adults and children weighing ≥30 kg (66 lbs). The event will be held from February 28 to March 3, 2025, in San Diego, California.