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Monday, January 13, 2025

ARS prelims, 2025 objectives

 Preliminary fourth quarter neffy® net product revenue of approximately $6.5 million

Preliminary cash, cash equivalents and short-term investments of $314.0 million at year-end 2024 to support an operating runway of at least three years

Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 7:30am PT

  • Product revenue: Preliminary neffy net product revenue for the fourth quarter of 2024 was approximately $6.5 million, with total net product sales for 2024 of approximately $7.1 million since neffy became available to wholesalers and pharmacies on September 23, 2024. More than 14,500 neffy two-pack units were delivered in the fourth quarter of 2024, including more than 1,500 units in the last week of 2024.
  • Cash position: Cash, cash equivalents and short-term investments were approximately $314.0 million as of December 31, 2024. ARS Pharma reiterates its guidance that the company expects its cash, cash equivalents and short-term investments to be sufficient to fund its current operating plan for at least three years.

2025 Key Strategic Priorities for Accelerating neffy U.S. Sales and Recent Highlights

  • Increase demand and traction among target prescribers, with continued sales force and medical science liaison engagement, expansion of the company’s neffy Experience Program, and rollout of additional continuing medical education (CME) programs
    • More than 3,000 healthcare providers have prescribed neffy to date, of which 80 percent are in the highest decile categories for prescribing epinephrine
    • More than 1,750 healthcare providers have participated in the neffy Experience Program
  • Expand commercial access of neffy
    • Express Scripts, the second largest pharmacy benefits manager in the U.S., added neffy to its commercial national formularies in November 2024
    • On track for more than 60 percent commercial coverage by the end of the first quarter of 2025, and more than 80 percent commercial coverage by the end of the third quarter of 2025
    • Contracting consistent with target long-term total gross-to-net revenue of 50 percent
  • Increase consumer awareness of neffy and availability of a needle-free option
    • Preparations are underway to launch a branded neffy direct-to-consumer marketing campaign beginning in May 2025
    • Designed to build momentum ahead of the ‘back-to-school’ season, the campaign will extend throughout the summer, driving brand recognition and encouraging patients to request neffy by name
    • In parallel, to amplify public awareness of the needle-free epinephrine option, Food Allergy Research and Education (FARE) is set to launch a public service announcement campaign featuring a celebrity ambassador with ARS Pharma support later this year
  • Obtain approval of neffy 1 mg for children who weigh 15 to 30 kg
    • The sNDA filed with the U.S. FDA for neffy for children who weigh 15 to 30 kg has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025
    • Based on review timelines and subject to approval, product availability of neffy 1 mg is expected in the second quarter of 2025

Presentation at the 43rd Annual J.P. Morgan Healthcare Conference
On Wednesday, January 15, 2025, at 7:30am PT, Richard Lowenthal, President and CEO of ARS Pharma, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference. A live webcast of the presentation and Q&A session can be accessed here or by visiting the investors section of the company’s website at www.ir.ars-pharma.com.

https://www.globenewswire.com/news-release/2025/01/13/3008466/0/en/ARS-Pharmaceuticals-Announces-Preliminary-Fourth-Quarter-2024-Financial-Results-and-2025-Objectives-for-neffy-epinephrine-nasal-spray.html

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