Eli Lilly (LLY) Q3 2025: Incretin Portfolio Drives 54% Revenue Growth, Orforglipron Scales Global Ambition

October 30, 2025 | By EarningsIQ Research

Eli Lilly’s third quarter delivered a decisive leap in both top-line growth and pipeline momentum, underpinned by the expanding reach of its incretin portfolio. Strategic manufacturing investments and a broadened R&D agenda signal Lilly’s intent to scale access globally, with Orforglipron positioned as a mass-market catalyst. The company’s guidance raise and operational execution reinforce its leadership in the rapidly evolving obesity and diabetes markets.

Summary

• Incretin Market Command: Lilly’s incretin franchise now captures nearly two-thirds of new U.S. prescriptions, reinforcing durable leadership.
• Pipeline Acceleration: Orforglipron and retatrutide both advance toward broad indications, targeting scalable global access and differentiated efficacy.
• Manufacturing Expansion: New U.S. and Puerto Rico facilities underpin volume ambitions for next-generation therapies.

Performance Analysis

Lilly’s Q3 was defined by a 54% year-over-year revenue surge, led by outsized growth from key products in obesity, diabetes, and neuroscience. The incretin analogs—Zepbound, Mounjaro, and related brands—drove both U.S. and international gains, with international markets now accounting for a growing share of volume as launches expand to 55 countries. Gross margin improved to 83.6%, reflecting favorable product mix despite lower realized prices and increased R&D and SG&A investments as the company scales for multiple global launches.

Performance margin—a Lilly-specific measure of profitability after R&D and commercial costs—rose by over eight percentage points to 48.3%, demonstrating strong operating leverage from volume gains. Prescription growth for Zepbound tripled year-over-year, and Mounjaro’s international ramp exceeded expectations, with 75% of ex-U.S. revenue now coming from out-of-pocket obesity patients. Neuroscience and oncology franchises also posted double-digit prescription growth, supported by new approvals and label expansions.

• U.S. Price Dynamics: While U.S. revenue grew 45%, price declined by 15% due to prior-period rebate adjustments, but underlying price erosion was contained to high single digits.
• International Demand: Ex-U.S. revenue grew over 100% in constant currency, with broad-based uptake and limited reimbursement in obesity, highlighting high consumer willingness to pay.
• R&D and Launch Investment: R&D spend rose 27% and SG&A 31%, reflecting a deliberate push into new indications and geographies.

Cash flow remains robust, supporting $1.3 billion in dividends and $700 million in share buybacks this quarter. The company’s guidance increase for both revenue and EPS signals confidence in continued execution and demand durability.

Executive Commentary

Strategic Positioning

1. Global Incretin Franchise Expansion

Lilly’s incretin analogs—GLP-1 receptor agonists for diabetes and obesity— now dominate both U.S. and international markets. The company’s share of new U.S. prescriptions approaches two-thirds, and launches in 55 countries have established strong out-of-pocket demand, even where reimbursement is limited. International markets are now a key growth lever, with 75% of non-U.S. Mounjaro revenue from obesity patients paying cash, signaling global clinical need and willingness to pay.

2. Orforglipron as a Mass-Market Catalyst

Orforglipron, an oral GLP-1 agonist, is positioned to unlock scalable access to incretin therapy. Phase III data demonstrate efficacy on par with injectables, and the once-daily pill format is expected to drive adoption among the broader population, including those with lower BMI or aversion to injections. Lilly is manufacturing at scale in anticipation of a global launch, aiming to reach millions of new patients and potentially establish Orforglipron as the “GLP-1 for all.”

3. Manufacturing and Supply Chain Investments

To support unprecedented demand, Lilly is investing in two new U.S. facilities and expanding Puerto Rico operations, targeting both small molecule and bioconjugate production. These moves are designed to address supply constraints and ensure capacity for both current and future therapies, including Orforglipron and next-generation assets like retatrutide.

4. R&D Diversification and Pipeline Depth

Lilly’s pipeline is broadening beyond core metabolic indications, with new Phase III starts in osteoarthritis pain, stress urinary incontinence, and neuroscience (including alcohol and opioid use disorders). Oncology and immunology pipelines are also advancing, with new approvals and positive late-stage readouts supporting future growth.

5. Commercial Model Evolution

Lilly Direct, the company’s direct-to-consumer platform, is gaining traction as a channel for bypassing traditional U.S. payer friction, especially for obesity medicines. The company is also adapting to evolving PBM models and price transparency initiatives, positioning clinical differentiation as the primary driver of formulary access.

Key Considerations

Lilly’s Q3 results highlight a business scaling rapidly across geographies, indications, and modalities. The company is executing on multiple fronts, but faces a complex landscape of payer dynamics, global pricing, and competitive innovation. Investors should weigh the following:

Key Considerations:

• Volume-Driven Growth: Prescription volume, not price, is the primary growth engine, especially as U.S. price erosion is contained but not eliminated.
• Global Access Strategy: Out-of-pocket demand in international markets validates the unmet need, but longer-term growth will depend on reimbursement expansion and payer negotiations.
• Pipeline Optionality: Orforglipron and retatrutide offer differentiated profiles for distinct patient segments, supporting both market segmentation and expansion.
• Manufacturing Execution: Timely completion and ramp-up of new facilities are critical to meeting global demand and avoiding supply bottlenecks.
• Commercial Channel Shifts: Expansion of direct-to-consumer models may reshape how patients access obesity and diabetes therapies, impacting margin and payer mix.

Risks

Key risks include supply chain execution, regulatory and payer pushback on pricing, and potential competitive pressure from both branded and biosimilar entrants. U.S. policy changes (such as IRA pricing and PBM reforms) could alter net price realization, while international volume may be sensitive to consumer price elasticity and reimbursement delays. Pipeline readouts carry inherent execution risk, especially as Lilly seeks to diversify indications beyond its core.

Forward Outlook

For Q4 2025, Lilly guided to:

• Continued double-digit revenue growth led by incretin analogs and new launches.
• Performance margin in the 45–46% range, reflecting ongoing investment in launches and R&D.

For full-year 2025, management raised guidance:

• Revenue: $63–$63.5 billion (up $2 billion at midpoint)
• Non-GAAP EPS: $23.00–$23.70

Management cited robust demand, favorable FX, and strong new product uptake as drivers. Additional factors include:

• Pending Orforglipron regulatory submissions and anticipated U.S. launch in 2026.
• Ongoing supply chain expansion and new manufacturing capacity coming online.

Takeaways

Lilly’s Q3 demonstrates operational leverage, pipeline depth, and a clear strategy to scale globally. The company’s leadership in incretin analogs is reinforced by both volume and clinical differentiation, while manufacturing investments and commercial innovation provide a foundation for future growth.

• Volume and Pipeline Drive Outperformance: Key franchises continue to outpace market growth, with Orforglipron poised to expand the addressable population.
• Execution on Multiple Fronts: Manufacturing, R&D, and commercial channels are aligned to support global ambitions and mitigate supply or access bottlenecks.
• Watch for Reimbursement and Pricing Dynamics: U.S. and international payer responses, as well as regulatory developments, will shape future margin and volume trajectories.

Conclusion

Lilly’s Q3 2025 results reflect a company executing at scale, with a robust pipeline and commercial strategy built to extend its leadership in obesity, diabetes, and beyond. The next phase hinges on the successful launch of Orforglipron, manufacturing ramp, and continued payer engagement globally.

Industry Read-Through

Lilly’s performance underscores the accelerating global demand for incretin-based therapies, with consumer willingness to pay out-of-pocket for obesity treatment signaling a major addressable market shift. Competitors face rising barriers to entry, as scale, clinical differentiation, and manufacturing capacity become decisive. PBM and pricing reforms in the U.S. may reset the competitive landscape, favoring innovators with superior clinical profiles. The rapid expansion of direct-to-consumer channels and payer model evolution will likely become a template for other therapeutic categories facing similar access and pricing challenges.

LLY Healthcare Pharmaceuticals Obesity Diabetes Incretin Pipeline Manufacturing