ADDED
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was approximately $ 1,094.9 million as of June 30, 2025 (the last trading day of the registrant s most recently completed second quarter) based on the closing price of $17.45 as reported on the Nasdaq Global Market on such date.
neffy and EURneffy are trademarks of ours that we use in this Annual Report.
Additional discussion of the risks listed in this summary, as well as other risks that we face, are set forth under Part I, Item 1A.
Some of the material risks associated with our business include the following: We are highly dependent on the successful commercialization of neffy .
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
Our Credit Agreement contains conditions and restrictions that limit our flexibility in drawing on the additional funds thereunder and in operating our business.
We may be required to repay our outstanding indebtedness under the Credit Agreement earlier than we expect and possibly at a time when we do not have sufficient capital to meet such obligations if an event of default occurs (including a material adverse change affecting our business), which could have a material adverse effect on our financial condition and results of operations.
neffy and EURneffy are trademarks of ours that we use in this Annual Report.
Overview Company Summary We are a biopharmaceutical company focused on the commercialization and development of neffy (currently identified in the European Union ( EU ) and United Kingdom ( U.K.
) by the trade name EURneffy and in China by the trade name ) for needle-free intranasal delivery of epinephrine for emergency treatment of Type I allergic reactions, including anaphylaxis.
REMOVED
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was approximately $ 466.1 million as of June 28, 2024 (the last trading day of the registrant s most recently completed second quarter) based on the closing price of $8.51 as reported on the Nasdaq Global Market on such date.
( Silverback ) initial public offering; and statements of belief and any statement of assumptions underlying any of the foregoing.
3 SUMMARY OF RISKS ASSOCIATED WITH OUR BUSINESS An investment in shares of our common stock involves a high degree of risk.
Additional discussion of the risks listed in this summary, as well as other risks that we face, are set forth under Part I, Item 1A, Risk Factors in this Annual Report.
Some of the material risks associated with our business include the following: We are highly dependent on the successful commercialization of neffy in the United States and in the EU for its currently approved indications in those jurisdictions.
Our commercial success depends on our ability to obtain and maintain sufficient intellectual property protection for neffy , our current and future intranasal epinephrine technology product candidates and other proprietary technologies.
neffy is a trademark of ours that we use in this Annual Report.
Overview Company Summary We are a biopharmaceutical company focused on the commercialization and development of neffy (previously referred to as ARS-1 and currently identified in the EU by the trade name EURneffy ) for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis.
neffy is the first and only FDA and European Commission ( EC )-approved needle-free epinephrine product, and the first new delivery method for epinephrine in more than 35 years.
We believe neffy s no needle, no injection approach addresses a significant unmet need in the use of epinephrine, which, except for neffy , is currently approved only in injectable formulations for the emergency treatment of Type I allergic reactions.