Eli Lilly and Company is showcasing a multi-faceted growth strategy, with recent developments underscoring that its expansion is not solely reliant on its highly successful metabolic franchise. The company is making significant strides in oncology while simultaneously preparing for a major commercial launch, highlighting its operational depth.
Strategic Inventory Build for Oral Weight-Loss Candidate
Ahead of a key regulatory decision, Eli Lilly has taken a notable operational step. According to its 2025 annual report, the pharmaceutical giant has already built $1.5 billion in advance inventory for its oral weight-loss drug candidate, orforglipron. The U.S. Food and Drug Administration (FDA) is currently reviewing the treatment, with a decision anticipated in April.
Market analysts view this substantial inventory investment as a strategic move to prevent the supply constraints that initially hampered the launches of its other drugs, Mounjaro and Zepbound. Research firm GlobalData projects that, if approved, orforglipron could generate sales of up to $13 billion by 2031.
Oncology Division Scores Major Clinical Trial Win
In a separate but equally important development, Eli Lilly announced positive Phase 3 trial results for its cancer drug Retevmo (selpercatinib). The LIBRETTO-432 study met its primary endpoint, demonstrating a statistically significant improvement in event-free survival for patients with early-stage RET fusion-positive non-small cell lung cancer (NSCLC).
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Company officials emphasized the significance of this trial, noting it is the first randomized Phase 3 study to evaluate a selective RET kinase inhibitor as an adjuvant therapy for this specific patient population. While overall survival data are not yet mature, a favorable trend was observed. Jacob Van Naarden, head of Lilly Oncology, commented that cancer medicines often achieve their greatest impact when administered early in the treatment journey.
Strong Financial Momentum and Upcoming Catalysts
These updates follow the company’s robust fourth-quarter 2025 earnings report, released earlier this month. Eli Lilly posted revenue of $19.3 billion, a 43% year-over-year increase. Earnings per share came in at $7.54, surpassing estimates of $6.67. The growth was primarily fueled by continued strong demand for Mounjaro, with Q4 sales of $7.4 billion (+110%), and Zepbound, which brought in $4.2 billion (+123%).
Looking ahead, management has reaffirmed ambitious guidance for 2026, targeting revenue between $80 billion and $83 billion and earnings per share in the range of $33.50 to $35.00.
Eli Lilly’s stock closed at $1,040 last Friday. Investors have several near-term events to watch, including a presentation by Chief Financial Officer Lucas Montarce at the TD Cowen Health Care Conference on March 2nd. This precedes the expected FDA verdict on orforglipron in April.
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