This quarterly report represents an earnings surprise of 1,400%. A quarter ago, it was expected that this company would post a loss of $0.18 per share when it actually produced a loss of $0.20, delivering a surprise of -11.11%. ARS Pharmaceuticals, Inc. (SPRY) came out with quarterly earnings of $0.52 per share, beating the Zacks Consensus Estimate of a loss of $0.04 per share. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items. Empirical research shows a ...

ARS Pharmaceuticals (SPRY) Q4 2024 Earnings Call March 20, 2025 08:30 AM ET Company Participants Justin Chakma - Chief Business Officer & SecretaryRichard Lowenthal - Founder, President, CEO & DirectorEric Karas - Chief Commercial OfficerKathleen Scott - Chief Financial OfficerRyan Deschner - Vice President - Equity ResearchAlexa Deemer - Biotechnology Equity Research AssociateLouise Chen - Managing DirectorJulian Harrison - Managing Director Conference Call Participants Roanna Ruiz - Senior Managing Direct ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other jurisdicti ...

Financial Performance - Preliminary nef y® net product revenue for Q4 2024 was approximately $6.5 million, with total net product sales for 2024 of approximately $7.1 million since launch[5]. - Cash, cash equivalents, and short-term investments were approximately $314.0 million as of December 31, 2024, expected to support operations for at least three years[5]. - The company aims to achieve a long-term total gross-to-net revenue target of 50% through consistent contracting[9]. Product Delivery and Usage - Over 14,500 nef y two-pack units were delivered in Q4 2024, including more than 1,500 units in the last week of the year[5]. - More than 3,000 healthcare providers have prescribed nef y to date, with 80% in the highest decile for prescribing epinephrine[5]. - More than 1,750 healthcare providers have participated in the nef y Experience Program to date[5]. Market Strategy and Coverage - The company is on track for over 60% commercial insurance coverage by the end of Q1 2025 and over 80% by the end of Q3 2025[9]. - A branded direct-to-consumer marketing campaign for nef y is set to launch in May 2025, aimed at increasing brand recognition[9]. Regulatory and Conference Participation - The sNDA for nef y 1 mg for children weighing 15 to 30 kg has a PDUFA target action date of March 6, 2025, with expected product availability in Q2 2025[9]. - The company will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025[1].

Core Insights - ARS Pharmaceuticals reported a total net product revenue of $7.3 million from neffy® (epinephrine nasal spray) in the U.S. for 2024 since its launch in late September 2024 [1] - The FDA approved neffy 1 mg for children aged four and older, expanding its market to approximately 2 million younger children at risk of severe allergic reactions [1][2] - The company ended 2024 with $314.0 million in cash, cash equivalents, and short-term investments, ensuring a financial runway for at least three years [1][7] Financial Performance - Total revenue for Q4 2024 was $86.6 million, including $6.7 million from neffy sales and $73.5 million from collaboration revenue with ALK [5] - Full-year 2024 revenue totaled $89.1 million, reflecting a significant increase from previous years [5][22] - Net income for Q4 2024 was $49.9 million, translating to $0.51 per share basic and $0.48 diluted, while full-year net income was $8.0 million, or $0.08 per share [5][22] Business Developments - The U.S. commercial launch of neffy has seen strong execution, with increasing physician adoption and positive patient feedback [2][6] - The company engaged with approximately 9,000 priority healthcare providers, with over 4,000 healthcare providers submitting neffy prescriptions [7] - ARS Pharma plans to initiate a Phase 2b clinical trial for intranasal epinephrine as a treatment for chronic spontaneous urticaria in Q2 2025 [8] Market Expansion - The company anticipates receiving milestone payments from ALK of approximately $5 million in 2025, with half recognized as revenue [7] - neffy is expected to be available in pharmacies for pediatric use starting May 2025 [7] - Regulatory submissions for neffy in the U.K. and Canada are underway, with decisions anticipated by mid-2025 and year-end 2025, respectively [7] Strategic Initiatives - A broad direct-to-consumer marketing campaign for neffy is set to launch in May 2025, targeting the peak epinephrine prescribing season [7] - The neffyinSchools program aims to provide eligible K-12 schools with free neffy doses for emergency use [7] - The company has secured favorable coverage decisions from major payers, aiming for over 60% access to commercial lives by Q1 2025 [7]

neffy 1 mg is the first and only needle-free epinephrine treatment approved for younger children SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that the U.S. Food and Drug Administration (FDA) has approved neffy® 1 mg (epinephrine nasal spray) for the treatment of Type I Allergic Reacti ...

Core Viewpoint - The FDA has approved neffy® 1 mg, a needle-free epinephrine nasal spray, for treating Type I allergic reactions, including anaphylaxis, in children aged 4 years and older weighing between 15 to < 30 kilograms, marking a significant innovation in epinephrine delivery for this demographic in over 35 years [1][3]. Group 1: Product Details - Neffy 1 mg is the first needle-free epinephrine treatment approved for younger children, providing a precise dose via a nasal spray without the need for a nasal hold time [1][2]. - The device has a shelf-life of 24 months at room temperature and can withstand temperatures up to 122°F (50°C) for up to 3 months [3]. - Neffy can be effectively used by children as young as 10 and even by untrained individuals, such as babysitters or teachers [3]. Group 2: Market Context - Approximately one in 13 children in the general population have severe food allergies, with over 40% experiencing severe reactions [2]. - Despite the benefits of early epinephrine use, around 40% of patients delay treatment, and 56% of caregivers are apprehensive about using needle-based auto-injectors [2][16]. - Nearly 40% of U.S. epinephrine prescriptions are written for children under 18, with a significant portion for those weighing 15 to 30 kilograms [3]. Group 3: Company Commitment and Accessibility - ARS Pharmaceuticals aims to enhance access and affordability for neffy 1 mg, with most commercially insured patients expected to pay no more than $25 for two devices through a co-pay savings program [4]. - The neffyConnect program will assist patients and caregivers with treatment guidance, medication fulfillment, and financial support [4]. - The neffy 1 mg is anticipated to be available in the U.S. by the end of May 2025 [4][5].

Core Points - ARS Pharmaceuticals, Inc. will host a conference call on March 20, 2025, at 8:30 a.m. ET to discuss its fourth quarter and full year 2024 financial results and business highlights [1] - The company is dedicated to empowering at-risk patients and caregivers to protect against allergic reactions that could lead to anaphylaxis [3] Company Information - ARS Pharmaceuticals is commercializing neffy® 2 mg (trade name EURneffy® in the EU), an epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [3] - The product is indicated for emergency treatment of allergic reactions due to insect stings or bites, foods, medicinal products, and other allergens, as well as idiopathic or exercise-induced anaphylaxis in both adults and children [3] Upcoming Events - ARS Pharma Management will participate in several investor conferences, including a fireside chat at the Leerink Partners Global Healthcare Conference on March 10, 2025, and investor meetings at the 37th Annual Roth Conference from March 16-18, 2025 [4]

Core Insights - ARS Pharmaceuticals has expanded access to neffy, an epinephrine nasal spray, to approximately half of all patients managing Type 1 allergic reactions by adding it to 30 formularies, including those of Cigna Healthcare, Navitus Health Systems, and OptumRx [1][2][3] Group 1: Product Information - Neffy is the first FDA-approved epinephrine nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, for patients weighing 30 kg or more [4][7] - The product is designed for rapid administration, is portable, and has a shelf-life of 30 months with temperature stability up to 122 degrees Fahrenheit [4] - A supplemental NDA for neffy 1 mg, aimed at children over four years old weighing 15 to 30 kg, has a target action date of March 6, 2025, with expected availability by the end of May 2025 [5] Group 2: Market Impact - The addition of neffy to formularies improves coverage for approximately 20 million individuals diagnosed with severe Type I allergic reactions who require epinephrine therapy [3][15] - Millions of patients now have improved access to neffy through commercial insurance, with a low copay of $25 available for those insured by OptumRx, Cigna Healthcare, and Navitus Health Systems [2][3] Group 3: Company Commitment - ARS Pharmaceuticals is committed to ensuring continued access to neffy for patients and caregivers, highlighting the critical demand for a nasal spray option in the severe allergy community [2][3] - The company is actively working with UnitedHealthcare to add neffy to their formulary [2]

Core Insights - ARS Pharmaceuticals, Inc. announced the presentation of nine studies at the 2025 AAAAI Annual Scientific Meeting, highlighting the efficacy and safety of neffy, an intranasal epinephrine product for managing anaphylaxis [1][2][20] - Neffy has demonstrated lower symptom scores within 10 minutes compared to traditional intramuscular auto-injectors, supporting its use as a needle-free option for anaphylaxis management [1][19] - The product is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or greater [12][20] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and caregivers to manage severe allergic reactions effectively [20] - Neffy is the first FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis, in both adults and children [2][20] - The company aims to advance scientific knowledge regarding epinephrine administration and improve treatment accessibility for patients [2][20] Research Findings - Studies presented will cover pharmacokinetics and pharmacodynamics of neffy under various conditions, including self-administration and allergic challenges [1][2] - Findings from Japanese and Chinese studies confirm the efficacy and safety of neffy, demonstrating its comparable performance to intramuscular injections [1][19] - The research includes insights into the physiological responses of different age groups to epinephrine administration [6][7] Meeting Activities - The AAAAI Annual Scientific Meeting will feature oral presentations and poster sessions detailing the clinical research on neffy [2][11] - ARS Pharma will host various onsite activities, including a product theatre and an exhibit booth to engage with attendees [11][20]