Semaglutide's Unrivaled Dominance in Cardiometabolic Therapies: Why Novo Nordisk's Moat is Widening

The European Medicines Agency's (EMA) recent positive opinion for Ozempic's (semaglutide) PAD label expansion marks a pivotal milestone for Novo Nordisk. By demonstrating a 13% improvement in walking distance for patients with type 2 diabetes and PAD—via the STRIDE trial—semaglutide becomes the first therapy to address functional outcomes in this population. This underscores its unique ability to tackle atherosclerosis-driven complications across diabetes, cardiovascular disease (CVD), kidney disease, and obesity.

The SOUL trial (obesity), FLOW trial (CKD progression reduction), and now STRIDE form an unassailable evidence base, positioning semaglutide as the only GLP-1 RA with proven benefits across these indications. Competitors like Eli Lilly's Trulicity or Sanofi's Ozefo lack this breadth, confined to narrower glycemic or weight-loss focuses.

Semaglutide's real-world evidence (RWE) advantage further deepens its moat. With over 33 million patient-years of safety data, Novo can rapidly expand labels and fend off generic or biosimilar threats. The PAD approval alone opens a $2B+ market, while pending submissions in heart failure and metabolic liver disease add incremental upside.

Critically, Novo's pipeline—spanning weekly oral semaglutide, inhaled formulations, and long-acting depot injections—ensures sustained leadership. Rivals are years behind in developing comparable formulations, while regulatory hurdles for new GLP-1 RAs grow steeper amid heightened scrutiny of cardiovascular safety.

Investment Thesis: NVO's stock trades at 20x 2025E EPS, undervaluing its $20B+ annual revenue run rate from semaglutide's expanding indications. With a 54% reduction in PAD progression (STRIDE subanalysis) and 24% kidney risk reduction (FLOW), semaglutide's “one drug, many markets” strategy is underappreciated. Buy, with a 12-month price target of $550 (25% upside).

The competitive moat is not just scientific—it's structural. Novo's data depth and regulatory agility ensure semaglutide remains the go-to therapy for cardiometabolic multimorbidity. This is a decade-long growth story, and the PAD approval is just the latest chapter.