Following Hims & Hers’ announcement of a compounded semaglutide pill priced at $49 per month, Novo Nordisk issued a public statement on February 5, 2026, denouncing the product as “illegal mass compounding” that poses patient safety risks. The company emphasized that only its FDA-approved oral formulation, developed with proprietary SNAC absorption technology, has undergone rigorous clinical trials for safety, efficacy and consistent manufacturing quality. Novo Nordisk signaled its intent to pursue legal and regulatory action, citing potential violations of the Federal Food, Drug, and Cosmetic Act related to unapproved finished drug products.

Novo Nordisk highlighted that compounded semaglutide formulations have not been evaluated by the FDA for purity, dosage accuracy or bioequivalence, in contrast to its branded products which met agency standards through multi-phase clinical trials involving over 4,000 patients. The company reminded consumers and healthcare providers that compounded drugs are not FDA-approved and urged stakeholders to review FDA guidance clarifying that compounding pharmacies cannot market “generic equivalents” of branded GLP-1 therapies. Novo Nordisk also noted past FDA warnings about unauthorized compounding of GLP-1 agonists and cited a 2024 advisory warning on adverse events linked to substandard compounded batches.

In its full-year 2025 earnings release, Novo Nordisk forecast a 5% to 13% decline in adjusted sales and operating profit for 2026, a stark reversal from 2025’s 10% constant-currency revenue growth. Management attributed the softer outlook to intensified pricing pressures in the United States under recent drug-cost legislation, increased rebate obligations, and accelerated competition from both injectable and oral GLP-1 therapies. The company expects volume growth to partially offset margin compression but cautioned that net price erosion could reach 8% next year.

To navigate the challenging environment, Novo Nordisk plans to deploy a 10 billion-DKK share buyback program in 2026 and reinvest an additional 12 billion DKK into R&D, targeting next-generation GLP-1 and dual-agonist candidates now in Phase II and III trials. CEO Mike Doustdar reiterated confidence in the oral semaglutide launch slated for Q2 2026, projecting it will drive incremental volume gains despite near-term profitability headwinds. The company maintains a long-term view that strong brand equity, manufacturing scale and pipeline depth will underpin a recovery in operating margins post-2027.