Eli Lilly Builds $1.5 Billion Orforglipron Stockpile Ahead of April FDA Decision

Eli Lilly had $1.5 billion worth of pre-launch inventory of its experimental oral weight-loss drug, a filing showed on Thursday, ahead of an expected decision by the U.S. Food and Drug Administration in April. The scale of the inventory marks a sharp increase from last year, when the company revealed $550 million in pre-launch supply for the pill, orforglipron.

Orforglipron won a fast-track review voucher from the FDA that could cut review times to as little as one to two months, from the typical 10 to 12 months for most new medicines. Most drugmakers include such inventories, or assets, in their financial statements to show how much drug product has been manufactured right before approval.

Lilly has previously said it would have plenty of supply to launch the much-anticipated weight-loss pill in several countries nearly simultaneously if the pill wins U.S. approval. The company has indicated it intends to ensure a sufficient supply of the weight loss drug at launch and is seeking to avoid the shortages that have affected the broader obesity drug market.

The move underscores Lilly's manufacturing strategy as it prepares for a potential near-simultaneous launch across multiple markets if the drug secures U.S. approval. With the launch not coming until 2026, this earlier-than-normal inventory build is certainly much larger than normal. The strategy reflects Lilly's intent to move quickly once approved and establish an early position in what is expected to remain a highly competitive obesity treatment market.

Danish rival Novo Nordisk launched its once-daily weight-loss pill in the U.S. earlier this month, with prescriptions hitting more than 26,000 in the second full week after launch, IQVIA data showed.

Lilly recently issued 2026 revenue guidance of $80.00 billion to $83.00 billion. That outlook effectively embeds management's expectations around ongoing GLP-1 demand and a potential orforglipron launch. The company completed $4.08 billion of share repurchases under its 2024 buyback and agreed to acquire Orna Therapeutics for up to $2.40 billion in cash.

The company has entered a $1 billion artificial intelligence drug discovery collaboration with Nvidia to support its research pipeline. The Nvidia partnership is aimed at turning Lilly's sizeable R&D budget and data into a more efficient discovery engine, potentially shortening timelines and widening the pool of drug candidates across oncology, immunology and neurology.