Commitments and Contingencies |
9 Months Ended |
|---|---|
Sep. 30, 2026 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | 9. Commitments and Contingencies Contingencies From time to time, the Company may be involved in various legal proceedings and subject to claims that arise in the ordinary course of business. On July 24, 2023, Aera A/S, an IP consultancy firm in Denmark representing an unidentified opponent, filed a notice of opposition with the European Patent Office (the “EPO”) in respect of EP 3678649 (the “EP ‘649 Patent”), which is a patent directed to a nasal spray formulation of epinephrine, and uses thereof. Following oral proceedings on October 7, 2025, the EPO Opposition Division upheld the validity of all claims of the EP ‘649 Patent. The opponent appealed the decision of the Opposition Division, and the Company filed its response to the grounds of appeal on July 3, 2026. Oral proceedings before the Board of Appeal are scheduled for July 1, 2027. The Company intends to continue to vigorously defend the EP ’649 Patent, although the Board of Appeal may reverse the decision of the Opposition Division in whole or in part. On March 25, 2025, AptarGroup, Inc. (“AptarGroup”) and Aptar France SAS (collectively, “Aptar”) filed a suit against ARS Pharmaceuticals, Inc. and ARS Pharmaceuticals Operations, Inc. in the United States District Court for the Southern District of New York. Aptar alleges the Company violated the Defend Trade Secrets Act (18 USC § 1836), misappropriated trade secrets under New York state law, and committed various breaches of contract. The complaint was served to the Company, and the Company filed a motion to dismiss on June 12, 2025. Aptar subsequently filed an opposition to the motion to dismiss on July 28, 2025, and the Company filed a reply brief on August 27, 2025. On March 30, 2026, the Court granted in part and denied in part the motion to dismiss, dismissing the trade secret misappropriation claim under New York state law and allowing the other claims to proceed. On April 29, 2026, Aptar filed a motion for leave to file an amended complaint to replead the previously dismissed claim, which the Company opposed. The Court granted the motion for leave to file an amended complaint on June 17, 2026, and the Company filed its answer to the amended complaint on July 6, 2026. Aptar moved to further amend the complaint on October 14, 2026, seeking to add Silgan Dispensing Systems Corp. as an additional defendant. The Company intends to vigorously defend itself in this matter. On September 29, 2025, the Company filed a lawsuit against AptarGroup in the U.S. District Court for the Southern District of California, alleging that AptarGroup violated federal antitrust law in connection with its sale of certain constituent parts of neffy. On December 16, 2025, Aptar moved to dismiss or in the alternative transfer ARS’s lawsuit to the Southern District of New York. On January 27, 2026, ARS filed an opposition to Aptar’s motion to dismiss, and Aptar filed a reply brief on February 27, 2026. On July 17, 2026, the Court declined to address Aptar’s motion to dismiss arguments and instead transferred the Company’s lawsuit to the Southern District of New York. On August 7, 2026, Aptar again moved to dismiss the complaint. The Company filed an opposition on August 21, 2026, and Aptar filed a reply brief on August 28, 2026. The Company intends to diligently pursue this claim and seek all available relief. On August 29, 2025, the Company filed a lawsuit against Lupin, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos.: 10,576,156, 10,682,414, 11,173,209, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838 and seeking a permanent injunction preventing market entry of a generic product from Lupin prior to the expiry of such patents. The lawsuit follows a Paragraph IV certification notice letter received from Lupin on August 13, 2025, advising the Company that Lupin submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture and sell a generic version of the Company’s product neffy 2 mg (epinephrine nasal spray) prior to the expiration of the patents referenced above. On February 26, 2026, the Company filed a lawsuit against Lupin, Inc., Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos.: 10,576,156, 10,682,414, 11,173,209, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838 and seeking a permanent injunction preventing market entry of a generic product from Lupin prior to the expiry of such patents. The lawsuit follows a Paragraph IV certification notice letter received from Lupin on February 6, 2026, advising the Company that Lupin submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture and sell a generic version of the Company’s product neffy 1 mg (epinephrine nasal spray) prior to the expiration of the patents referenced above. On October 1, 2026, the Company and Lupin entered into a stipulation whereby Lupin, while maintaining its challenges to validity, agreed that its proposed generic 1mg and 2mg epinephrine nasal spray products meet all of the limitations of the asserted claims of U.S. Patents Nos. 10,682,414, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838. On April 10, 2026, the Company filed a lawsuit against Cipla Ltd. and Cipla USA, Inc. (collectively, “Cipla”) in the United States District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos.: 10,576,156, 10,682,414, 11,173,209, 11,191,838, 11,717,571, 11,744,895, 11,918,655, and 12,324,838 and seeking a permanent injunction preventing market entry of a generic product from Cipla prior to the expiry of such patents. The lawsuit follows a Paragraph IV certification notice letter received from Cipla on March 25, 2026, advising the Company that Cipla submitted an Abbreviated New Drug Application to the FDA seeking approval to manufacture and sell a generic version of the Company’s product neffy 1 mg and 2 mg (epinephrine nasal spray) prior to the expiration of the patents referenced above. On July 10, 2026, Jonico, Inc. d/b/a Berlin Pharmacy filed a putative class action lawsuit against the Company, and its wholly owned subsidiary, ARS Pharmaceuticals Operations, Inc., in the U.S. District Court for the Western District of Pennsylvania, Civil Action No. 3:26-cv-01339. The complaint alleges that the Company sent, or caused to be sent, facsimile advertisements promoting neffy to pharmacies, without the prior express invitation or permission of the recipients and without the requisite opt-out notices, in violation of the Telephone Consumer Protection Act, 47 U.S.C. § 227 (the “TCPA”). The TCPA provides for statutory damages of $500 per violation, which may be trebled up to $1,500 per violation for willful or knowing violations; the complaint also seeks injunctive relief. On September 28, 2026, the Company moved to dismiss the complaint for failure to state a claim, arguing that the alleged facsimile does not qualify as an “advertisement” under the TCPA. On October 19, 2026, before the Company’s motion to dismiss was fully briefed and decided, the plaintiff filed an amended complaint (the “First Amended Complaint”). The First Amended Complaint asserts the same TCPA claim as the original complaint. The Company disputes these allegations and intends to vigorously defend itself. On August 5, 2026, a purported stockholder of the Company filed a securities class action complaint in the U.S. District Court for the Southern District of California against the Company and certain of its current and former officers. The complaint alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder, by making material misstatements or omissions concerning the Company’s expected timeline for expanded insurance coverage for neffy. The complaint seeks, on behalf of the putative class, unspecified damages, pre- and post-judgment interest, attorneys’ fees, expert fees and costs, as well as class certification and such other relief as the court may deem just and proper. The Company intends to vigorously defend against the claims in this action. Any potential loss arising from this claim is not currently probable or estimable. Regardless of the outcome, involvement in legal proceedings may have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. The Company cannot predict the outcome of these suits, and failure by the Company to obtain favorable resolutions could have a material adverse effect on its business, results of operations, and financial condition. The Company’s chances of success on the merits of these suits are still uncertain and any possible loss or range of loss cannot be reasonably estimated and as such the Company has not recorded a liability as of September 30, 2026. Except as described above, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or other body pending or, to the knowledge of the Company’s executive officers, threatened against or affecting the Company, the Company’s common stock, any of its subsidiaries or its subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect. Unconditional Purchase Obligations and Commitments Unconditional purchase obligations and commitments are defined as agreements to purchase goods or services that are enforceable and legally binding (non-cancelable, or cancelable only in certain circumstances). In the normal course of business, the Company enters into arrangements with suppliers, manufacturers, and various other companies that supply goods or services. These arrangements can include unconditional purchase obligations and commitments. The total remaining unconditional purchase obligations related to the supply of raw materials is $55.6 million as of September 30, 2026. Purchase obligations by year are as follows: 2026 ($9.4 million), 2027 ($11.8 million), 2028 ($13.8 million), and $2.9 million per year thereafter through 2035. During the three and nine months ended September 30, 2026, the Company made zero and $1.6 million in payments under these agreements, respectively. During the three and nine months ended September 30, 2025, the Company made $0.7 million and $8.0 million in payments under these agreements, respectively. Subsequent to period end, the Company entered into an amendment to certain arrangements related to the supply of raw materials, reducing the remaining unconditional purchase obligations by $23.9 million. The total amount of commitments related to the ALK Co-Promotion Agreement is $18.2 million as of September 30, 2026. Commitments by year are as follows: 2026 ($4.4 million), 2027 ($10.7 million), 2028 ($1.8 million), and 2029 ($1.3 million). No payments were made under this agreement during the three and nine months ended September 30, 2026 and 2025. The amounts above do not represent the entire anticipated expenditure in the future but represent only those items for which the Company is contractually obligated. For this reason, these amounts do not provide an indication of the Company’s expected future cash outflows related to purchases and commitments. |