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- **Revenue Growth Acceleration**: 2025 full-year revenue up 45% to $65.2B, driven by Mounjaro, Zepbound, and new product launches.
- **AI and Manufacturing Expansion**: $55B+ investment in manufacturing capacity, with 180% YoY increase in obesity med production. New AI collaboration with NVIDIA to accelerate drug discovery.
- **2026 Outlook**: Guidance for $80-83B revenue and $3.50-35 EPS, fueled by orforglipron launch, international Mounjaro growth, and Medicare/Medicaid access rollouts.
- **Key Risks**: Price erosion (low-mid teens YoY) and new manufacturing site costs may pressure margins, but volume growth (e.g., oral GLP-1s) expected to offset.

**【CEO Summary Section】**
- **2025 Performance Highlight**: Full-year revenue grew 45% to $65.2 billion, driven by key products like Mounjaro, Zepbound, and new launches (e.g., Inluriyo, Omvoh). Gross margin remained stable at 83.2%, while R&D expenses increased 26%.
- **Pipeline and AI Investment**: 39 business development deals added clinical assets (e.g., Scorpion, Verve). New AI collaboration with NVIDIA aims to accelerate drug discovery. Manufacturing expansion ($55B+ investment) increased production capacity for obesity meds by 180% YoY.
- **Government Access Agreement**: Medicare/Medicaid patients can access obesity meds for $50/month, with 1M+ patients using direct-to-patient platform (e.g., Zepbound self-pay vials).

**【CFO Financial Commentary】**
- **Q4 2025 Results**: Revenue up 43% YoY, EPS $7.54 (86% YoY growth). Non-GAAP performance margin 47.2%, up 4.2pts YoY. 2026 Guidance: Revenue $80-83B (25% growth), EPS $3.50-35. Key drivers: U.S. oral GLP-1 launches (e.g., orforglipron Q2 2026), international Mounjaro expansion, and Medicare/Medicaid access rollouts.
- **Financial Dynamics**: Price erosion (low-mid teens YoY) offset by volume growth. Gross margin stable to slightly down due to new manufacturing sites. R&D and marketing expenses expected to rise with pipeline expansion.

**【Q&A Key Highlights】**
- **Orforglipron Launch Metrics**: Targeting $50/month co-pay for Medicare patients. Early data shows oral GLP-1s expand market (e.g., 1/3 of new Zepbound starts via self-pay). 2026 launch in 40+ countries, with U.S. as primary growth driver.
- **International Mounjaro Growth**: Became incretin market leader outside U.S., with 55%+ new prescriptions in type 2 diabetes. 2026 focus: China NRDL listing, reimbursement expansion, and patient activation in chronic weight management.
- **Immunology Strategy**: Combining incretins with immunology therapies (e.g., Taltz + Zepbound in psoriasis) shows efficacy. Phase III trials for brenipatide in asthma and retatrutide in knee osteoarthritis expected to read out in 2026.
- **Medicare Access Impact**: Orforglipron launch coincides with Medicare coverage (July 2026). Anticipate 10-20% of LillyDirect business migrating to Medicare, with employer opt-ins increasing in 2027.
- **Price Elasticity**: Direct-to-patient pricing ($2.99/Zepbound vial) drives utilization. Oral GLP-1s positioned as "titration-free" alternatives to injectables, with eloralintide Phase III cardiovascular outcomes trial underway.

Eli Lilly and Company (LLY) Q4 2025 Earnings Call Transcript

- **Revenue Super Growth**: 54% YoY to $12.3B, driven by Mounjaro (+100% Europe), Zepbound (U.S. prescriptions tripled), and LillyDirect (40% vial share).
- **Pipeline Breakthroughs**: Orforglipron global submissions for obesity; retatrutide Phase III starts; Kisunla EU approved.
- **Expanded Manufacturing**: $1.3B in dividends, $700M buybacks; new U.S. facilities for bioconjugates and small molecules.
- **Strategic Pricing**: Orforglipron poised for 100M+ patients via direct-to-consumer and PBM channels; Mounjaro 75% non-U.S. revenue from out-of-pocket obesity.

**【CEO Summary Section】**
- Q3 2025 revenue grew 54% YoY, driven by key products like Mounjaro and Zepbound. U.S. market share in incretin analogs reached 60%, with Lilly medicines accounting for 60% of new prescriptions.
- Pipeline milestones included FDA approval for Inluriyo (imlunestrant) and Kisunla in Europe, positive Phase III results for Jaypirca and Verzenio, and global regulatory submissions for orforglipron in obesity.
- Manufacturing expansion announced: new facilities in Virginia (bioconjugate/monoclonal antibodies) and Texas (small molecules), plus Puerto Rico expansion.

**【CFO Financial Commentary】**
- Q3 revenue: $12.3B (54% YoY growth). Non-GAAP EPS: $7.02 (vs. $1.18 YoY). Gross margin: 83.6% (up 1.4pp YoY) due to favorable product mix.
- U.S. revenue +45% YoY (Mounjaro, Zepbound growth), Europe +100% (Mounjaro uptake). Japan/China/ROW: 24%/22%/51% growth.
- Full-year guidance updated: Revenue $63-63.5B (midpoint +$2B), non-GAAP EPS $23-23.70.

**【R&D & Pipeline Update】**
- **Cardiometabolic:**
  - Orforglipron: 4 Phase III trials completed (obesity, type 2 diabetes). Global submissions for obesity underway; U.S. launch expected 2026.
  - Retatrutide: Phase III trials for obesity and knee osteoarthritis. First readout (TRIUMPH-4) expected late 2025.
  - Muvalaplin: Phase III for Lp(a) reduction in cardiovascular disease.
- **Oncology:**
  - Jaypirca: Phase III data shows PFS benefit in CLL. Inluriyo approved for ER+/ESR1-mutated breast cancer.
  - Verzenio: Positive OS data in high-risk early breast cancer.
- **Neuroscience:**
  - Kisunla EU approval; U.S. prescriptions +50% QoQ. Remternetug Phase III for preclinical Alzheimer's.
  - Brenipatide: Phase II for alcohol use disorder; Phase III for obesity expected 2026.

**【International Growth】**
- Mounjaro launched in 55 countries, 75% of non-U.S. revenue from obesity (out-of-pocket). Strong uptake in China, Brazil, India.
- LillyDirect (direct-to-consumer) accounts for 40% of U.S. Zepbound vial prescriptions.

**【Q&A Highlights】**
- **Orforglipron Launch Strategy:**
  - U.S. and global launches in 2026; pricing strategy to balance consumer access and payer coverage.
  - Potential for 100M+ patients globally, leveraging LillyDirect and PBM partnerships.
- **Mounjaro International Growth:**
  - 75% of non-U.S. revenue from obesity; 55 country launches. Reimbursement discussions ongoing in Europe.
- **GLP-1 Pricing Dynamics:**
  - Semaglutide IRA negotiations may impact 2027 Part D pricing, but Lilly focuses on differentiation (efficacy, convenience).
  - Orforglipron's oral, once-daily profile positions it for broader market share.


Eli Lilly and Company (LLY) Q3 2025 Earnings Call Transcript

- **Revenue Surge**: 38% YoY growth driven by Zepbound (3.4B sales) and Mounjaro (5.2B sales). U.S. incretin market grew 41% Q2 vs. Q2 2024.
- **Pipeline Breakthroughs**: Orforglipron Phase III success (27 lbs weight loss) and tirzepatide cardiovascular protection data. SURMOUNT-MMO trial enrolling 15,000 obesity patients.
- **Manufacturing Scale**: 1.8x H2 2025 incretin dose production vs. H2 2024. New U.S. facilities announced Q3.
- **Strategic Acquisitions**: SiteOne's pain portfolio and Verve's genetic cardiovascular medicines expand pipeline.
- **Pricing Strategy**: LillyDirect Zepbound at >50% discount. Opposed to U.S. price importation, advocating systemic reform.

**【CEO Summary Section】**
- **Revenue Growth**: Q2 2025 revenue increased 38% YoY, driven by key products like Zepbound, Mounjaro, and Ebglyss. U.S. revenue grew 38%, Europe 77% (constant currency), and China 19% (constant currency).
- **Product Highlights**: Mounjaro became the U.S. market leader in type 2 diabetes incretin prescriptions. Zepbound maintains 66% share of the branded anti-obesity market. Lilly gained market share in the incretin analog class for the fourth consecutive quarter.
- **R&D Milestones**: Positive Phase III results for orforglipron (ATTAIN-1) and tirzepatide (SURPASS-CVOT). Acquisitions of SiteOne Therapeutics (pain portfolio) and Verve Therapeutics (genetic cardiovascular medicines).
- **Manufacturing Expansion**: Produced 1.6x more salable incretin doses in H1 2025 vs. H1 2024. Announcing locations for 2 new U.S. manufacturing facilities later in Q3.
- **Pricing Strategy**: Direct-to-consumer channel (LillyDirect) for Zepbound at >50% discount off list price. Opposed to U.S. importation of foreign price controls, emphasizing need for systemic reform.

**【CFO Financial Commentary】**
- **Financial Performance**: Q2 non-GAAP EPS of $6.31 (61% YoY growth). Gross margin 85% (3ppt YoY improvement). R&D expenses +23%, marketing/sales +30%.
- **Guidance Update**: Full-year revenue raised to $60-62B (prev. $57-59B). Non-GAAP EPS $21.75-23 (prev. $20.50-22.50). 2025 incretin dose production expected to be 1.8x H2 2024 levels.
- **Geographic Growth**: U.S. revenue growth offset by 8% price decline. Europe and China growth driven by Mounjaro launches. Rest-of-world impacted by base-period stocking.

**【R&D & Pipeline Highlights】**
- **Tirzepatide**: SURPASS-CVOT demonstrated cardiovascular protection (8% lower MACE-3 vs. Trulicity). SURMOUNT-MMO trial enrolling 15,000 patients for obesity-related morbidity/mortality.
- **Orforglipron**: ATTAIN-1 showed 7.8-12.4% body weight loss (27 lbs at highest dose). Safety profile consistent with GLP-1 class. 4 additional Phase III trials expected to report by end-2025.
- **Pirtobrutinib**: BRUIN CLL-314 trial met PFS non-inferiority vs. ibrutinib. Regulatory submissions planned for CLL/SLL.
- **New Acquisitions**: SiteOne's Nav1.8 inhibitor for pain; Verve's PCSK9 and ANGPTL3 genetic medicines for cardiovascular disease.

**【Q&A Key Highlights】**
- **Orforglipron Efficacy**: 12.4% weight loss vs. Wegovy's 15.1% in OASIS-4. Lilly emphasizes convenience (oral vs. injectable) and production scale advantages.
- **CVS Impact**: Zepbound prescriptions declined in July post-CVS exclusion. Q3 growth rate expected to be negatively impacted, but long-term outlook remains strong.
- **Employer Coverage**: ~50-55% employer opt-in for anti-obesity meds. New benefit designs (e.g., Evernorth out-of-pocket caps) may increase coverage.
- **Global Pricing Strategy**: Exploring net parity for new products between U.S. and Europe. LillyDirect channel for Zepbound addresses U.S. coverage gaps.
- **Compounding Risks**: Opposed to compounded semaglutide, citing patient safety concerns. U.S. regulatory enforcement needed to eliminate counterfeit meds.


Eli Lilly and Company (LLY) Q2 2025 Earnings Call Transcript

- **Revenue Super Growth**: 45% YoY rise driven by Mounjaro ($3.8B) and Zepbound ($2.3B) leadership in diabetes and obesity.
- **Orforglipron Breakthrough**: Phase 3 data shows GLP-1-like efficacy (1.3-1.6% HbA1c reduction, 16lb weight loss) with tolerable safety profile.
- **Manufacturing Ambition**: $50B U.S. investment to ensure domestic supply, targeting 100% U.S. production for U.S. market.
- **Pricing Strategy Shift**: Moving away from rebate-heavy models to transparent, competitive pricing for self-pay channels.
- **Tariff Watch**: Current tariffs minimal impact, but industry risks if expanded.


**【CEO Summary Section】**
- Q1 revenue grew 45% YoY, driven by key products like Mounjaro and Zepbound, which contributed $7.5 billion in revenue.
- Highlighted Phase 3 data for oral GLP-1 receptor agonist orforglipron, showing 1.3-1.6% HbA1c reduction and 16-pound weight loss in Type 2 diabetes patients.
- Announced $50 billion in U.S. manufacturing investments since 2020, emphasizing domestic supply chain resilience.
- Addressed tariffs, stating current tariffs have limited impact but expanded tariffs could harm the industry.

**【CFO Financial Commentary】**
- Q1 non-GAAP EPS: $3.34 (excluding $1.72 impact from acquired IPR&D charges).
- Gross margin: 83.5% (up 1ppts YoY) due to cost improvements and product mix.
- R&D expenses: $1.57 billion (8% YoY increase) for late-stage assets and early-stage research.
- Non-GAAP performance margin: 42.6% (up 11ppts YoY) reflecting strong profitability.

**【R&D Update】**
- Orforglipron Phase 3 trial (ACHIEVE-1) met efficacy targets, with 65% of patients achieving HbA1c ≤6.5% and 16-pound weight loss.
- Safety profile comparable to injectable GLP-1s, with low discontinuation rates (4-8%).
- Planned Phase 3 readouts for obesity and diabetes trials over next 12 months.

**【Q&A Highlights】**
- **CVS Formulary Decision**: Zepbound removed from preferred list, but company emphasizes oral convenience and pipeline (e.g., orforglipron) to maintain share.
- **Pricing Strategy**: Focus on transparent pricing vs. competitors, reducing gross-to-net spreads.
- **Tariff Risks**: Current tariffs minimal impact, but expanded tariffs could hurt exports.
- **Market Share Dynamics**: Zepbound leads U.S. branded obesity market (60% new prescriptions), despite PBM access challenges.


Eli Lilly and (LLY)-1 May 25-2025 Q1 Earnings call transcript

- **Revenue Growth Surpasses Expectations**: 2024 full-year revenue up 32% YoY, exceeding guidance by $4B, with Q4 up 45% YoY.
- **New Products Drive Growth**: Mounjaro and Zepbound contributed $3.1B incremental revenue, with Zepbound capturing 52% of U.S. anti-obesity market.
- **Pipeline Momentum**: 8 new Phase III programs started in 2024; positive Phase III results for Zepbound in obesity.
- **Margin Expansion**: Gross margin - OpEx ratio target 41.5-43.5% in 2025 (340bp expansion YoY).
- **Shareholder Returns**: $3B returned in 2024; $15B buyback program announced for 2025.
- **Manufacturing Scale-Up**: $23B+ invested since 2020; 2025 capacity to produce 1.6x 2024 H1 sellable doses.
- **R&D Investment**: 2025 plans include Phase III programs for KRAS G12C inhibitor and orforglipron, with retatrutide data expected Q3 2025.
- **Market Access**: Zepbound OSA Medicare coverage expected H2 2025; global Mounjaro launches constrained by supply.


**【CEO Opening Remarks】**
- Full-year 2024 revenue grew 32% YoY, exceeding guidance by $4 billion, with Q4 revenue up 45% YoY.
- New products drove $3.1 billion in incremental revenue, led by Mounjaro and Zepbound.
- Pipeline advancements include 8 new Phase III programs and positive Phase III results for Zepbound in obesity.
- Manufacturing investments exceed $23 billion since 2020, with capacity to produce 1.5x more incretin doses in H2 2024 vs H2 2023.
- Returned $3 billion to shareholders via dividends and buybacks, with a new $15 billion buyback program announced.

**【CFO Financial Review】**
- Q4 2024 revenue: $11.4 billion (45% YoY growth), driven by Mounjaro (+$3.5 billion) and Zepbound (+$1.9 billion U.S. segment).
- Gross margin: 83.2% (up 1.2ppt YoY), benefiting from favorable product mix.
- R&D expenses: $2.8 billion (18% YoY), supporting 8 new Phase III programs.
- SG&A expenses: $5.3 billion (26% YoY), driven by commercial investments.
- Operating income: $5.6 billion (104% YoY growth).
- 2025 guidance: Revenue $58-61 billion (32% YoY growth), non-GAAP EPS $22.50-24.

**【CFO 2025 Guidance】**
- U.S. incretin market growth expected to continue at 2024 pace, with Mounjaro launches in new international markets.
- Trulicity volume decline expected as patients switch to newer incretins.
- Gross margin - OpEx ratio target: 41.5-43.5% (340bp YoY expansion).
- R&D investment to accelerate Phase III programs and new Phase III starts.

**【CFO Pricing & Mix】**
- U.S. realized prices down 5% Q4 2024 vs Q4 2023 due to rebate adjustments.
- Europe revenue grew 82% (61% ex-one-time payment), Japan +27%, China +13%.
- Global Zepbound share of anti-obesity market increased 3ppt to 52%.

**【CFO Supply Chain】**
- No wholesaler backorders at year-end; U.S. direct-to-consumer vials increased uptake.
- 2025 manufacturing capacity: 1.6x 2024 H1 sellable doses vs 2024 H1.

**【CFO Shareholder Returns】**
- 2024: $3 billion returned via dividends ($2.1B) and buybacks ($0.9B).
- 2025: $15B buyback program announced; 7th consecutive 15% dividend increase.

**【CFO Margin Expansion】**
- 2024: Gross margin - OpEx ratio 38.1% (vs 34.7% 2023).
- 2025 target: 41.5-43.5% (340bp expansion).
- Long-term margin target: High 40s, balanced against R&D investment needs.

**【CFO R&D Investment】**
- 2024: 8 new Phase III programs started; 21 Phase III trials read out.
- 2025: 2 new Phase III programs planned (KRAS G12C inhibitor in NSCLC, orforglipron in hypertension).
- Triple-acting incretin (retatrutide) Phase III data expected Q3 2025.

**【CFO Market Access】**
- U.S. commercial coverage for Zepbound OSA: >50% employer opt-in; Medicare coverage expected H2 2025.
- Global Mounjaro launches in new markets despite supply constraints.

**【CFO Risks】**
- Foreign exchange headwind expected in 2025.
- U.S. Part D price cuts could impact realized prices.
- Manufacturing scale-up for orforglipron (oral GLP-1) planned for 2026.


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