ARS Pharmaceuticals, a biopharmaceutical company, has reported its unaudited condensed consolidated financial statements for the three months ended March 31, 2025, in its Quarterly Report on Form 10-Q. The company is focused on the commercialization and development of neffy, a needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis.
The market opportunity for neffy in the United States alone is significant. With a current list price for a two-pack of neffy and the target total gross-to-net yield, the estimated 6.5 million patients currently prescribed an epinephrine autoinjector in the United States represents an initial addressable market opportunity of approximately $3 billion in annual net sales, while the remaining 13.5 million diagnosed patients that have not been prescribed an epinephrine product represent an additional addressable market opportunity of approximately $7 billion in annual net sales.
The company's commercial launch of neffy in the United States began in September 2024, with the initiation of a direct sales force of approximately 120 individuals targeting high-volume epinephrine prescribers. The company also received FDA approval for neffy 1 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in patients who are four years of age and older and weigh 15 kg to less than 30 kg. The commercial launch of neffy 1 mg in the United States began in May 2025.
In addition to its U.S. commercial launch, the company has received marketing authorization in the EU for EURneffy, and it anticipates that EURneffy will be made available to patients in certain EU member states in 2025. Regulatory review of neffy is ongoing in Canada, the U.K., China, Japan, and Australia, with filings submitted during the fourth quarter of 2024.
The company reported a net loss from operations of $37.2 million for the three months ended March 31, 2025, compared to a net loss of $13.2 million for the same period in 2024. As of March 31, 2025, the company had cash, cash equivalents, and short-term investments of $275.7 million. ARS Pharmaceuticals has primarily funded its operations through proceeds from the Merger, private placement of convertible preferred stock, issuance of common stock, licensing, supply and distribution arrangements with commercialization partners, bank debt, and limited net product sales.
The company has also entered into a collaboration, license, and distribution agreement with ALK, granting ALK a worldwide exclusive license under certain patents and know-how to develop, manufacture, and commercialize products containing epinephrine administered intranasally. This collaboration aims to expand the market reach of ARS Pharmaceuticals' products.
ARS Pharmaceuticals has been focused on developing intellectual property, conducting product development and clinical trials, organizing and staffing, business planning, raising capital, building infrastructure, pre-commercial and commercial activities, and providing general and administrative support for these operations. However, the company has had limited net product sales since beginning commercial operations in September 2024.
The company's financial condition and future operations are dependent on its ability to consistently generate positive net income, raise additional funds, and enter into favorable arrangements with third parties. ARS Pharmaceuticals anticipates that it may need to finance its operations through existing cash, cash equivalents, short-term investments, equity offerings, debt financings, and other capital sources, including collaborations, strategic alliances, marketing, distribution, or licensing arrangements.
ARS Pharmaceuticals does not own or operate manufacturing facilities and relies on third-party manufacturers and suppliers for its products. The company expects to continue to do so to meet its nonclinical, clinical, and commercial activities.
Following these announcements, the company's shares moved 0.45%, and are now trading at a price of $13.35. For more information, read the company's full 10-Q submission here.
