SAN DIEGO – In a significant move for ARS Pharmaceuticals, Inc., the company has entered into a material definitive agreement with ALK-Abelló A/S, expanding the reach of its epinephrine nasal spray, known as EURneffy in the European Union.
The agreement, announced today, grants ALK an exclusive license to develop, manufacture, and commercialize the product for various human uses, including emergency treatment of allergic reactions and anaphylaxis, across multiple global markets, excluding the United States and several other regions.
Under the terms of the collaboration, signed on Sunday, ARS will receive an upfront payment of $145 million from ALK. The deal also includes potential regulatory and commercial milestones that could total an additional $20 million, as well as sales-based milestones that could reach up to $300 million.
Notably, $55 million of these sales-based milestones are contingent on ARS securing regulatory approval for the product in Canada by a specified deadline.
ARS is also set to benefit from tiered royalty payments on net sales, which are anticipated to be in the mid- to high-teens percentage range. These royalties are subject to standard reductions and will be payable until the expiration of the relevant patents, 15 years from the first commercial sale, or the end of regulatory exclusivity in each country.
To support the collaboration, ARS is committed to transferring existing marketing authorizations within ALK's territory and conducting development and regulatory activities to obtain additional approvals. ALK, in turn, is tasked with using commercially reasonable efforts to secure and maintain regulatory approval in its territories, including through the European Commission.
The agreement also includes a commercial supply agreement, with ARS supplying ALK's product requirements for five years, after which ALK may opt to manufacture the products themselves or through a contract manufacturer.
The partnership can be terminated by either party in the event of insolvency, an uncured material breach, or under certain other specified conditions, such as challenges to ARS's patents by ALK or the commercialization of competing non-injectable products by ALK in the United States.
Statements made in the press release about the future are considered forward-looking and involve risks and uncertainties, as detailed in ARS's filings with the Securities and Exchange Commission.
In other recent news, ARS Pharmaceuticals has reported several significant developments. The company secured a supply deal with Nuova Ompi S.r.l., a Stevanato Group subsidiary, for the provision of glass microvials for their emergency medication, neffy®. This agreement is crucial for ensuring a steady supply of essential components for the neffy® product line.
Additionally, ARS Pharmaceuticals updated its manufacturing agreement with Renaissance Lakewood, LLC, extending the contract for the production of neffy nasal unit dose sprays.
The FDA has approved neffy, a needle-free epinephrine treatment for Type I Allergic Reactions, now available by prescription across the United States. The company is also seeking FDA approval for neffy 1 mg, targeting younger children with severe allergies.
ARS Pharmaceuticals has also announced the availability of neffy® by prescription across the United States. The company submitted a supplemental New Drug Application (sNDA) for neffy® 1 mg, a needle-free epinephrine treatment for children.
The European Commission approved EURneffy, a needle-free adrenaline nasal spray, marking a milestone in allergy treatment.
Analyst firm Cantor Fitzgerald initiated coverage of ARS Pharmaceuticals with an Overweight rating, indicating a positive outlook for the company's potential.
InvestingPro Insights
ARS Pharmaceuticals, Inc. (SPRY) has shown remarkable market performance, with InvestingPro data revealing a staggering 368.9% price total return over the past year. This impressive growth aligns with the company's recent strategic move to partner with ALK-Abelló A/S for the global expansion of its epinephrine nasal spray.
InvestingPro Tips highlight that SPRY holds more cash than debt on its balance sheet, which could provide financial flexibility as the company navigates this new partnership and potential expansion. Additionally, analysts anticipate sales growth in the current year, which may be further bolstered by the upfront payment and potential milestone earnings from the ALK agreement.
However, investors should note that SPRY is currently trading near its 52-week high and at a high revenue valuation multiple. This suggests that the market has already priced in significant optimism regarding the company's prospects, including the recent licensing deal.
For those interested in a deeper analysis, InvestingPro offers 13 additional tips for SPRY, providing a more comprehensive view of the company's financial health and market position.
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