ARS Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

About this update from Ars Pharmaceuticals, Inc.

$7.3 million in total neffy ® (epinephrine nasal spray) U.S. net product revenue in 2024 since launch in late September 2024 neffy 1 mg approved by U.S. FDA for children aged four and older and weighing 15 kilograms to neffy to approximately 2 million younger, school-aged children at risk of a severe allergic reaction $314.0 million in cash, cash equivalents, and short-term investments at year-end 2024, supporting an increased investment in commercialization in 2025 while maintaining an operating runway of at least three years Company to host conference call today, March 20, 2025 at 5:30 a.m. PT / 8:30 a.m. ET SAN DIEGO , March 20, 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, today announced its financial results for the fourth quarter and full year ended December 31, 2024 , and provided highlights on the U.S. commercial launch of neffy , the first and only needle-free epinephrine emergency treatment for Type I allergic reactions, including anaphylaxis, as well as recent business updates. “Our strong execution throughout 2024 and into 2025 has positioned ARS Pharma for sustained growth and meaningful near-term value creation. The successful U.S. commercial launch of neffy , FDA approval of neffy 1 mg for younger children, and our expansion into new global markets mark key milestones in our effort to build a transformative franchise in severe allergy treatment,” said Richard Lowenthal , Co-Founder, President, and CEO of ARS Pharma. “Our momentum is highlighted by the steady increase in physician adoption, positive patient feedback, and growing payer coverage, which form a strong foundation for long-term success. With a solid financial position and a disciplined operational strategy, we are well-equipped to further accelerate adoption and drive significant impact for both our stakeholders and the millions of people who depend on life-saving epinephrine treatment.” Fourth Quarter and Full Year 2024 Financial Results ALK-Abelló (ALK) Accounting Treatment : Under the terms of the companies’ licensing agreement signed in November 2024 , ARS Pharma received a non-refundable, upfront cash payment of $145 million from ALK. Of the total cash payment, $73.5 million was included in ARS Pharma’s fourth quarter 2024 revenue. Of the remaining $71.5 million , $69.4 million was treated as a financing liability and $2.1 million was treated as a contract liability on the company’s balance sheet due to Generally Accepted Accounting Principles (GAAP) accounting treatment. Under the terms of the licensing agreement, ARS Pharma holds the option to repurchase rights to certain regions partnered to ALK. Per GAAP, the portion of the $145 million cash payment that is attributable to the regions eligible for repurchase is treated as a financing liability instead of revenue. Notably, this accounting treatment did not impact the amount of non-refundable cash proceeds received and ARS Pharma has sole discretion in their use. Revenue : Total revenue for the fourth quarter of 2024 was $86.6 million , which included $6.7 million in net product revenue from neffy sales in the United States , $73.5 million in collaboration revenue from ALK, $6 million in collaboration revenue from the company’s licensing partner in Japan ( Alfresa Pharma ), and $0.4 million in revenue from supply agreements. Full-year 2024 revenue totaled $89.1 million , reflecting $7.3 million in neffy sales, $81.5 million in collaboration revenue, and $0.4 million from supply agreements. Research and Development (R&D) Expenses : R&D expenses for the fourth quarter and full-year 2024 were $3.0 million and $19.6 million , respectively. These costs were primarily associated with product manufacturing to support the commercial launch of neffy in the U.S. , along with other product development and personnel-related expenses. Selling, General and Administrative (SG&A) Expenses : SG&A expenses for the fourth quarter and full-year 2024 were $35.5 million and $71.7 million , respectively, primarily comprised of personnel-related and marketing expenses associated with the commercial launch of neffy , as well as general operating expenses. Net Income : Net income for the fourth quarter of 2024 was $49.9 million , or $0.51 per share basic and $0.48 diluted. Net income for the full-year 2024 was $8.0 million , or $0.08 per share basic and diluted. Business Outlook Cash Position & Operating Runway : As of December 31, 2024 , ARS Pharma had cash, cash equivalents, and short-term investments of $314.0 million , with 97,954,172 shares of common stock outstanding. The company reiterates its guidance that its financial position is expected to support its operating plans for at least the next three years. Anticipated 2025 ALK Milestones : ARS Pharma projects to receive cash proceeds from milestone payments by ALK of approximately $5 million in both the second and fourth quarters of 2025. In accordance with GAAP, for cash payments under the terms of the ALK agreement, approximately half of the projected milestone payments would be recognized as revenue, and the remainder would be added to the financing liability on the company’s balance sheet. neffy U.S. Commercial Launch Highlights ARS Pharma continues to execute the U.S. commercial launch of neffy . Key achievements to date include: Direct sales force engagement with approximately 9,000 priority healthcare providers, with neffy prescriptions submitted by more than 4,000 healthcare providers via BlinkRx through neffyConnect . Approximately 81% of prescribing physicians are among the highest decile allergists. Engagement with more than 1,000 physicians at the 2025 American Academy of Allergy , Asthma and Immunology (AAAAI) Annual Scientific Meeting, with a significant company presence, including nine scientific presentations and a non-CME program. Enrollment of approximately 2,500 allergists in the neffy Experience Program, exceeding the company’s initial program target enrollment of 1,000 allergists, with approximately 15,000 doses of neffy available to allergists for their use in treating anaphylaxis. Multiple favorable coverage decisions secured, including by Express Scripts , Cigna Healthcare , OptumRx , Navitus Health Systems , and TRICARE, with ongoing discussions and contract negotiations with other key payors, keeping the company on track for more than 60% access to commercial lives under contract by the end of the first quarter of 2025, and more than 80% by early third quarter of 2025. Addition of neffy to Medicaid coverage with no prior authorization in Texas , Alabama and Montana , with additional states expected to follow throughout 2025. Of note, commercial insurance, Medicaid and cash pay accounted for approximately 85-90% of all epinephrine prescriptions dispensed in 2024 in the United States . Broad direct to consumer (DTC) marketing campaign to be initiated in May 2025 , prior to the peak epinephrine prescribing season over the summer, which will include connected and linear TV, print, social media and influencer campaigns, as well as broad and targeted advertising. Successful launch of ARS Pharma’s neffy inSchools program, offering eligible K-12 schools in the U.S. the opportunity to receive two cartons (four single-use doses) of neffy 2 mg at no cost for emergency use through the School Health Corp. SHConnect platform. The program includes provisions for 1 mg dose upon availability, and replacement doses when used or expired. Global Regulatory Approvals and Activities for neffy and EUR neffy U.S. Pediatric Approval : On March 5, 2025 , the U.S. FDA approved ARS Pharma’s sNDA for neffy 1 mg as an emergency treatment for Type I allergic reactions, including anaphylaxis, in children aged four and older and weighing 15 kilograms to < 30 kilograms (33 to

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