Company: WW
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029511
Chunk: 92

Company: WW INTERNATIONAL, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 92
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 against med-spas, medical practices and telehealth providers, and such action or litigation could be brought against us. The Manufacturing Supplier is legally permitted to produce compounded semaglutide injection while the approved branded GLP-1 drug products (i.e., Ozempic and Wegovy) (the “Drug Products”) appear on the FDA drug shortage list. The Drug Products were added to the FDA drug shortage list in 2022. In a Declaratory Order issued on February 21, 2025, the FDA determined that the semaglutide injection product shortage is resolved and removed the Drug Products from the shortage list. As part of the Declaratory Order, the FDA stated that 503A pharmacies will be permitted to compound injectible semaglutide until April 22, 2025 and that 503B outsourcing facilities will be permitted to compound injectible semaglutide until May 22, 2025. In October 2024, the FDA took similar actions with respect to injectible tirzepatide drug products, when it resolved the shortage for those products and provided a discretionary enforcement period during which 503A pharmacies and 503B outsourcing facilities were permitted to produce compounded tirzepatide. Those actions are currently subject to ongoing litigation and the FDA has stated that it will permit the compounding of tirzepatide drug products by exercising enforcement discretion while the relevant litigation is pending. The Manufacturing Supplier must operate in compliance with the FDA’s requirements and produce compounded semaglutide only during the applicable period of enforcement discretion and may not be able to fulfill the prescriptions prescribed by our clinicians after the expiration of such period. Additionally, on October 22, 2024, Novo Nordisk filed a Petition with the FDA, requesting that semaglutide products be added to the lists of drug products that present demonstrable difficulties for compounding pursuant to the FDCA Sections 503A(b)(3) and 503B(a)(6) (the “Demonstrable Difficulties for Compounding Lists”). If added to the Demonstrable Difficulties for Compounding Lists, 503A pharmacies and 503B facilities would be prohibited from producing compounded semaglutide under any circumstances, even if the FDA continues to exercise enforcement discretion with respect to the shortage or if it were added back to the drug shortage list. The regulatory landscape applicable to GLP-1s continues to rapidly evolve. Additionally, many branded GLP-1 medications are protected under intellectual property laws