Eli Lilly and Co. (NYSE:LLY) stock plunged on Thursday after the company released topline data from the Phase 3 ATTAIN-1 trial evaluating orforglipron, an investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist.
The trial included over 3,000 obese patients with a weight-related medical problem and without diabetes.
At 72 weeks, all three doses of orforglipron met the primary endpoint and all key secondary endpoints compared to placebo.
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For the primary endpoint, orforglipron 36 mg lowered weight by an average of 12.4% (27.3 lbs) compared to 0.9% (2.2 lbs) with placebo using the efficacy estimand. CNBC writes that Wall Street’s expectations were around 15%.
59.6% of participants taking the highest dose of orforglipron lost at least 10% of their body weight, while 39.6% lost at least 15%.
For comparison, Novo Nordisk A/S’ (NYSE:NVO) oral semaglutide 25 mg achieved a 16.6% weight loss vs. a 2.7% reduction with placebo after 68 weeks.
CagriSema achieved a weight loss of 22.7% after 68 weeks in one study and 15.7% in another.
The company said orforglipron was also associated with reductions in known cardiovascular risk markers, including non-HDL cholesterol, triglycerides, and systolic blood pressure in pooled analyses across all doses.
In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels by 47.7%.
The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity, the company said in a statement on Thursday.
About 10.3% of patients in the 36 mg group discontinued treatment due to side effects, compared with around 2.6% on placebo. The overall treatment discontinuation rates were 21.9% (6 mg), 22.5% (12 mg), and 24.4% (36 mg) for orforglipron vs. 29.9% with placebo.
Lilly says it is on track to submit orforglipron to global regulatory agencies by year-end and is making substantial investments to meet anticipated demand at launch.
Q2 Earnings
Eli Lilly also released better-than-expected second-quarter earnings on Thursday and raised 2025 guidance.
The U.S. pharma giant reported second-quarter revenue of $15.56 billion, up 38% year over year, beating the consensus of $14.39 billion, driven by a 42% increase in volume, partially offset by a 6% decrease due to lower realized prices.
Key products revenue grew to $10.40 billion in the quarter, led by Zepbound and Mounjaro.
The company reported an adjusted EPS of $6.31, up from $3.92 a year ago, beating the consensus of $5.53.
For the second quarter, worldwide Mounjaro revenue increased 68% to $5.20 billion. U.S. revenue was $3.30 billion, an increase of 37%, reflecting strong demand, partially offset by lower realized prices.
Revenue outside the U.S. increased to $1.90 billion compared with $677.2 million in the same quarter a year ago, primarily driven by volume growth, including entry into new markets.
U.S. Zepbound revenue increased 172% to $3.38 billion, primarily driven by increased demand, partially offset by lower realized prices.
Verzenio (a breast cancer drug) revenue increased 12% to $1.49 billion, driven by volume growth.
Guidance
Eli Lilly raised fiscal year 2025 sales guidance from $58 billion-$61 billion to $60 billion-$62 billion versus the consensus of $59.45 billion.
The obesity drug maker raised 2025 adjusted earnings guidance from $20.78-$22.28 per share to $21.75-$23.00 versus the consensus of $21.59.
Price Action: LLY stock is trading lower by 7.04% to $693.85 premarket at last check Thursday.
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