7e5148c59f5715a942942777dfe1572e34c881292999805ce51d78f69ebbb985

| Geographical Segment | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|----------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| **U.S. Revenue (in millions)** | $4,660  **[0000059478-23-000025_q422lillysalesandearningsp.htm:2]**  | $4,436.2  **[0000059478-23-000162_lly-20230331.htm:10]**  | $5,531.4  **[0000059478-23-000221_lly-20230630.htm:12]**  | $5,368.1  **[0000059478-23-000284_lly-20230930.htm:13]**  | $6,460  **[0000059478-24-000032_q423lillysalesandearningsp.htm:2]**  | $5,694.4  **[0000059478-24-000118_lly-20240331.htm:10]**  | $7,835.2  **[0000059478-24-000187_lly-20240630.htm:12]**  | $7,813.6  **[0000059478-24-000242_q324lillysalesandearningsp.htm:2]**  |
| **Europe Revenue (in millions)** | N/A | $1,090.9  **[0000059478-23-000162_lly-20230331.htm:10]**  | $1,177.6  **[0000059478-23-000221_lly-20230630.htm:12]**  | $2,568.6  **[0000059478-23-000284_lly-20230930.htm:13]**  | N/A | $1,440.7  **[0000059478-24-000118_lly-20240331.htm:10]**  | $1,403.7  **[0000059478-24-000187_lly-20240630.htm:12]**  | $1,628.3  **[0000059478-24-000245_lly-20240930.htm:12]**  |
| **Japan Revenue (in millions)** | N/A | $387.2  **[0000059478-23-000162_lly-20230331.htm:10]**  | $455.6  **[0000059478-23-000221_lly-20230630.htm:12]**  | $390.8  **[0000059478-23-000284_lly-20230930.htm:13]**  | N/A | $363.9  **[0000059478-24-000118_lly-20240331.htm:10]**  | $462.7  **[0000059478-24-000187_lly-20240630.htm:12]**  | $429.1  **[0000059478-24-000245_lly-20240930.htm:12]**  |
| **China Revenue (in millions)** | N/A | $372.7  **[0000059478-23-000162_lly-20230331.htm:10]**  | $399.0  **[0000059478-23-000221_lly-20230630.htm:12]**  | $390.8  **[0000059478-23-000284_lly-20230930.htm:13]**  | N/A | $376.2  **[0000059478-24-000118_lly-20240331.htm:10]**  | $395.1  **[0000059478-24-000187_lly-20240630.htm:12]**  | $459.9  **[0000059478-24-000245_lly-20240930.htm:12]**  |
| **Other Foreign Countries Revenue (in millions)** | N/A | $673.1  **[0000059478-23-000162_lly-20230331.htm:10]**  | $748.5  **[0000059478-23-000221_lly-20230630.htm:12]**  | $780.3  **[0000059478-23-000284_lly-20230930.htm:13]**  | N/A | $892.9  **[0000059478-24-000118_lly-20240331.htm:10]**  | $1,206.1  **[0000059478-24-000187_lly-20240630.htm:12]**  | $1,108.2  **[0000059478-24-000245_lly-20240930.htm:12]**  |
| **Total Revenue (in millions)** | $7,300  **[0000059478-23-000025_q422lillysalesandearningsp.htm:2]**  | $6,960.0  **[0000059478-23-000162_lly-20230331.htm:10]**  | $8,312.1  **[0000059478-23-000221_lly-20230630.htm:12]**  | $9,498.6  **[0000059478-23-000284_lly-20230930.htm:13]**  | $9,350  **[0000059478-24-000032_q423lillysalesandearningsp.htm:2]**  | $8,768.0  **[0000059478-24-000118_lly-20240331.htm:10]**  | $11,302.8  **[0000059478-24-000187_lly-20240630.htm:12]**  | $11,439.1  **[0000059478-24-000242_q324lillysalesandearningsp.htm:2]**  |

5f474a94936fb4cca7b6dbf8f0f170f6c1dd2eb620260a962e2f03ec33f37075

| **Product Segment** | **Q4 2022** | **Q1 2023** | **Q2 2023** | **Q3 2023** | **Q4 2023** | **Q1 2024** | **Q2 2024** | **Q3 2024** |
|---------------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|
| **Trulicity** ($ million) | **1,940.0**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:7]**  | **1,977.1**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **1,812.5**  **[0000059478-23-000219_q223lillysalesandearningsp.htm:3]**  | **1,673.6**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **1,670.0**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:3]**  | **1,456.3**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **1,245.6**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:4]**  | **1,301.4**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Mounjaro** ($ million) | **279.2**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:8]**  | **568.5**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **979.7**  **[0000059478-23-000219_q223lillysalesandearningsp.htm:3]**  | **1,409.3**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **2,210.0**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **1,806.5**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **3,090.8**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:4]**  | **3,112.7**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Jardiance** ($ million) | **612.3**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:7]**  | **577.5**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **668.3**  **[0000059478-23-000219_q223lillysalesandearningsp.htm:3]**  | **700.8**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **798.1**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **686.5**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **769.6**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:5]**  | **686.4**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Humalog** ($ million) | **548.3**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:7]**  | **460.9**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **440.4**  **[0000059478-23-000221_lly-20230630.htm:11]**  | **395.4**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **366.6**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **538.7**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **631.6**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:5]**  | **534.6**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Zepbound** ($ million) | N/A | N/A | N/A | N/A | **175.8**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **517.4**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **1,243.2**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:4]**  | **1,257.8**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Verzenio** ($ million) | **808.0**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:7]**  | **750.9**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **926.8**  **[0000059478-23-000221_lly-20230630.htm:11]**  | **1,040.2**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **1,150.0**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **1,050.3**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **1,331.9**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:5]**  | **1,369.3**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Taltz** ($ million) | **707.8**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:7]**  | **527.0**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **703.9**  **[0000059478-23-000221_lly-20230630.htm:11]**  | **744.2**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **784.6**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **604.1**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **824.7**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:5]**  | **879.6**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Olumiant** ($ million) | **205.8**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:7]**  | **228.9**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **218.9**  **[0000059478-23-000221_lly-20230630.htm:11]**  | **231.4**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **243.5**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **217.4**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **227.7**  **[0000059478-24-000185_q224lillysalesandearningsp.htm:5]**  | **250.8**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Emgality** ($ million) | **175.6**  **[0000059478-23-000025_q422lillysalesandearningsp.htm:8]**  | **154.3**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **169.3**  **[0000059478-23-000221_lly-20230630.htm:11]**  | **168.5**  **[0000059478-23-000282_q323lillysalesandearningsp.htm:5]**  | **186.1**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]**  | **225.7**  **[0000059478-24-000116_q124lillysalesandearningsp.htm:5]**  | **192.0**  **[0000059478-24-000187_lly-20240630.htm:11]**  | **202.9**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Forteo** ($ million) | N/A | **122.3**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **148.0**  **[0000059478-23-000221_lly-20230630.htm:11]**  | **146.4**  **[0000059478-23-000284_lly-20230930.htm:11]**  | N/A | **61.3**  **[0000059478-24-000118_lly-20240331.htm:41]**  | **69.9**  **[0000059478-24-000187_lly-20240630.htm:11]**  | **118.1**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |
| **Cialis** ($ million) | N/A | **100.3**  **[0000059478-23-000162_lly-20230331.htm:10]**  | **115.6**  **[0000059478-23-000221_lly-20230630.htm:11]**  | N/A | **87.7**  **[0000059478-24-000032_q423lillysalesandearningsp.htm:4]** **[0000059478-24-000032_q423lillysalesandearningsp.htm:2]** **[0000059478-24-000032_q423lillysalesandearningsp.htm:3]**  | **139.3**  **[0000059478-24-000118_lly-20240331.htm:41]**  | **87.7**  **[0000059478-24-000187_lly-20240630.htm:11]**  | **91.5**  **[0000059478-24-000242_q324lillysalesandearningsp.htm:4]**  |

ebd894b8067085534e656c5a6a9a893cf201f10c7f4abeb74efb26070795ca2b

c11317554f9c84c07d1276db9cf981249d3ffbd54adc9f18866362b3b2940276

Eli Lilly and Company (LLY) is a global pharmaceutical company involved in the discovery, development, manufacturing, and marketing of products across various therapeutic areas. The company boasts a diverse product portfolio, with significant contributions from its incretin medicines, including Mounjaro and Zepbound, which have demonstrated strong sales growth **[0000059478-24-000032_q423lillysalesandearningsp.htm:0]** **[0000059478-24-000065_lly-20231231.htm:42]**. In addition to these, Eli Lilly's Growth Products category, featuring Verzenio, Taltz, and Jardiance, plays a crucial role in its revenue generation **[0000059478-24-000032_q423lillysalesandearningsp.htm:0]** **[0000059478-24-000185_q224lillysalesandearningsp.htm:2]**. The company actively engages in business development activities, such as acquisitions and collaborations, to enhance its product pipeline and expand capabilities in fields like radiopharmaceuticals and immunology **[0000059478-24-000065_lly-20231231.htm:73]** **[0000059478-24-000065_lly-20231231.htm:39]** **[0000059478-24-000065_lly-20231231.htm:99]**.

1. **Incretin Medicines** - Focuses on incretin-based therapies, with Mounjaro and Zepbound driving significant revenue growth.
2. **Growth Products** - Includes Verzenio, Taltz, and Jardiance, which are key contributors to the company's revenue.
3. **Business Development** - Engages in acquisitions and collaborations to expand capabilities in radiopharmaceuticals and immunology.

876cfa7ece6bdcf67fc215f16f490c274d12218280d697c6dea55d5ad14d8948

| Metric / Quarter                                          | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|-----------------------------------------------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| New Medicine Candidates in Clinical Development or Under Regulatory Review | **45**  **[0000059478-23-000082_lly-20221231.htm:61]**  | **45**  **[0000059478-23-000162_lly-20230331.htm:38]**  | **40**  **[0000059478-23-000221_lly-20230630.htm:43]**  | **45**  **[0000059478-23-000284_lly-20230930.htm:41]**  | **50**  **[0000059478-24-000065_lly-20231231.htm:65]**  | **50**  **[0000059478-24-000118_lly-20240331.htm:34]**  | **50**  **[0000059478-24-000187_lly-20240630.htm:39]**  | **50**  **[0000059478-24-000245_lly-20240930.htm:39]**  |

9be6fb4e8782d9b37e7f9224c59756a2d6d6b025c1a948f9e7bafb518eebe9da

1. **With the approval of Novartis's competitor in early breast cancer, how does Lilly plan to protect Verzenio's market share in the high-risk patient segment and mitigate potential erosion due to new entrants?**
2. **Given some employers are opting out of coverage for Mounjaro and Zepbound, what strategies does Lilly have to address payer restrictions and improve access, especially as you ramp up demand generation activities?**
3. **How do you anticipate the Inflation Reduction Act will impact key brands like Verzenio, and what preparations are you making for potential inclusion on the drug negotiation list in 2027?**
4. **After terminating the Phase IIb study of parasolimab in rheumatoid arthritis due to benefit-risk concerns, how will this affect your immunology pipeline, and what lessons have been learned for future development efforts?**
5. **Considering the issues with compounding pharmacies and the upcoming introduction of oral GLP-1 therapies like orforglipron, how is Lilly addressing the compounding crisis, and what are your expectations for FDA actions to resolve this on a product-by-product basis?**

8ffb891c11a547a190afd2a54ec4ee63e8fe2a575daf50a985a8f28db1e4e44a

d6f8ddc2da2c528fc173419c9620f8812f78d9f944fc2804a15029c2b14553e8

New Medicine Candidates in Clinical Development or Under Regulatory Review

9151a6eabb859df9425d767ec15c2016cf1dee93750a9f1056a1e0d701b49b9c

- AbbVie Inc.; Amgen Inc.; AstraZeneca PLC; Biogen Inc.; Bristol-Myers Squibb Company; Gilead Sciences Inc.; GlaxoSmithKline plc; Johnson & Johnson; Merck & Co., Inc.; Novartis AG; Novo Nordisk A/S; Pfizer Inc.; Roche Holding AG; Sanofi S.A.; and Takeda Pharmaceutical Company Limited (These companies are part of the peer group used for performance benchmarking and executive compensation purposes for 2023)  **[0000059478-24-000065_lly-20231231.htm:63]** .

d6d1d37678d238bc2458766712e4d593b9ef91f943859df7c778ad0c3cf31f8c

U.S.

- Europe

- Japan

- China

- Other Foreign Countries

Outside U.S.

Total Revenue

4b7bdcbeaecf00eaf4ecf4a3d26fb2911be3824d4dd1603f2e07ae7c079c40db

23794d91c53ae875c8e247d72561e35d9d06ee07c70c9e0dbcc977a6d161504a

### Q3 2024 Earnings Call
- **Issued Period**: Q3 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Revenue Guidance**: $45.4 billion to $46 billion, with approximately 50% growth in Q4 2024 compared to the same quarter last year  **[LLY_3404651_3]** .
  2. **Gross Margin**: Unchanged ratio of gross margin less operating expenses divided by revenue on both a reported and a non-GAAP basis  **[LLY_3404651_3]** .
  3. **Other Income and Expense**: $425 million to $325 million of expense on a reported basis, unchanged on a non-GAAP basis  **[LLY_3404651_3]** .
  4. **Effective Tax Rate**: Approximately 17%  **[LLY_3404651_3]** .
  5. **Earnings Per Share (EPS)**: $12.05 to $12.55 on a reported basis and $13.02 to $13.52 on a non-GAAP basis  **[LLY_3404651_3]** .

### Q2 2024 Earnings Call
- **Issued Period**: Q2 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Revenue Guidance**: Raised by $3 billion to $45.4 billion to $46.6 billion  **[LLY_3397445_4]** .
  2. **Revenue Growth**: 38% in the second half of the year, compared to 31% in the first half  **[LLY_3397445_4]** .
  3. **Gross Margin and Operating Expenses**: 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis  **[LLY_3397445_4]** .
  4. **Other Income and Expense**: $525 million to $425 million of expense on a reported basis, and $400 million to $300 million on a non-GAAP basis  **[LLY_3397445_4]** .
  5. **Effective Tax Rate**: Approximately 15%  **[LLY_3397445_5]** .
  6. **Earnings Per Share (EPS)**: $15.10 to $15.60 on a reported basis and $16.10 to $16.60 on a non-GAAP basis  **[LLY_3397445_5]** .

### Q1 2024 Earnings Call
- **Issued Period**: Q1 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Revenue**: Increased by $2 billion to $42.4 billion to $43.6 billion  **[LLY_3381483_3]** .
  2. **Gross Margin**: 32% to 34% on a reported basis and 33% to 35% on a non-GAAP basis  **[LLY_3381483_3]** .
  3. **Earnings Per Share (EPS)**: $13.05 to $13.55 on a reported basis and $13.50 to $14 on a non-GAAP basis  **[LLY_3381483_3]** .
  4. **Tax Rate**: Reaffirmed guidance considering Q1 results  **[LLY_3381483_3]** .

### Q4 2023 Earnings Call
- **Issued Period**: Q4 2023
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Revenue**: $40.4 billion to $41.6 billion, with 20% growth or 29% growth for the core business  **[LLY_3371997_6]** .
  2. **Revenue Growth Phasing**: Acceleration expected in the second half of the year  **[LLY_3371997_6]** .
  3. **Pricing**: High single-digit percent price decline expected  **[LLY_3371997_6]** .
  4. **Margin After Planned Costs**: 31% to 33% on a non-GAAP basis  **[LLY_3371997_6]** .
  5. **Gross Margin**: Approximately 80% on a non-GAAP basis  **[LLY_3371997_6]** .
  6. **Marketing and Administrative Expenses**: Expected to grow but at a slower pace than revenues  **[LLY_3371997_6]** .
  7. **R&D Expenses**: Expected to increase with a higher rate than marketing, selling, and administrative expenses  **[LLY_3371997_6]** .
  8. **Other Income and Expense**: $400 million to $500 million of expense  **[LLY_3371997_6]** .
  9. **Effective Tax Rate**: Approximately 14% on a non-GAAP basis  **[LLY_3371997_6]** .
  10. **Earnings Per Share (EPS)**: $12.20 to $12.70 on a non-GAAP basis  **[LLY_3371997_6]** .
  11. **Diluted Weighted Average Shares Outstanding**: Approximately 903 million  **[LLY_3371997_6]** .

1b190d6ca76f40edfebfaa08179eb03cb099988dc23ae7decc51d81cdc3d366e

| Program Details          | Program 1       |
|--------------------------|-----------------|
| Approval Date            | May 2021  **[0000059478-24-000245_lly-20240930.htm:6]** **[0000059478-24-000245_lly-20240930.htm:7]**  |
| End Date/Duration        | N/A             |
| Total additional amount  | $5.00 billion  **[0000059478-24-000245_lly-20240930.htm:6]** **[0000059478-24-000245_lly-20240930.htm:7]**  |
| Remaining authorization  | $1.98 billion  **[0000059478-24-000245_lly-20240930.htm:6]** **[0000059478-24-000245_lly-20240930.htm:7]**  |
| Details                  | N/A             |

8adf5ec176c3ea52678bd21a428593000bfc2714c6a7ca5a3116ce966980ac6d

| Name               | Position                                                                 | Start Date         | Short Bio                                                                                                                                                                                                 |
|--------------------|--------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| David A. Ricks     | Chair, President, and Chief Executive Officer                            | 2017               | David A. Ricks has been with Eli Lilly for **27 years**, holding various leadership roles, including Senior Vice President and President of Lilly Bio-Medicines. He also serves as a director on the board of Adobe Inc.  **[0001193125-24-181268_d843899dex99a1a.htm:100]** **[0000059478-24-000065_lly-20231231.htm:33]** **[0001193125-23-186293_d497638dex99a1a.htm:97]** .              |
| Anat Ashkenazi     | Executive Vice President and Chief Financial Officer                     | 2021               | Anat Ashkenazi succeeded Mr. Smiley as CFO on **February 9, 2021**. She previously held leadership positions such as Senior Vice President, Controller, and CFO of Lilly Research Laboratories  **[0001193125-23-255631_d564373dex99a1a.htm:89]** **[0000059478-24-000099_lly-20240322.htm:91]** .                                           |
| Eric Dozier        | Executive Vice President, Human Resources and Diversity                  | 2022               | Eric Dozier has been with Lilly for **26 years** and previously served as senior vice president and chief commercial officer for Loxo@Lilly, and vice president, global ethics and compliance officer  **[0000059478-24-000065_lly-20231231.htm:33]** **[0001193125-24-181268_d843899dex99a1a.htm:101]** .                                    |
| Anat Hakim         | Executive Vice President, General Counsel and Secretary                  | 2020               | Before joining Lilly, Anat Hakim was the senior vice president, general counsel, and secretary of WellCare Health Plans, Inc. from 2016 to 2020. She is a citizen of the U.S. and Israel  **[0000059478-24-000065_lly-20231231.htm:33]** **[0001193125-24-181268_d843899dex99a1a.htm:101]** **[0001193125-23-255631_d564373dex99a1a.htm:89]** .                                             |
| Edgardo Hernandez  | Executive Vice President and President, Manufacturing Operations         | 2021               | Edgardo Hernandez has held various leadership positions within Lilly, including senior vice president of global parenteral drug product, delivery devices, and regional manufacturing  **[0000059478-24-000065_lly-20231231.htm:33]** **[0001193125-24-181268_d843899dex99a1a.htm:102]** .                                                   |
| Patrik Jonsson     | Executive Vice President and President, Lilly Diabetes and Obesity       | 2024               | Patrik Jonsson has been with Eli Lilly for over three decades. He has served in roles such as Executive Vice President and President of Lilly Cardiometabolic Health and President of Lilly USA since 2024  **[0001193125-24-181268_d843899dex99a1a.htm:102]** **[0001193125-23-255631_d564373dex99a1a.htm:89]** .                                |
| Johna Norton       | Executive Vice President, Global Quality                                 | 2017               | Johna Norton has been with Lilly for **34 years** and is set to retire at the end of July 2024. She has held roles such as vice president of global quality assurance API manufacturing and product research and development  **[0000059478-24-000065_lly-20231231.htm:33]** **[LLY_3371997_10]** .               |
| Diogo Rau          | Executive Vice President and Chief Information and Digital Officer       | 2021               | Before joining Lilly, Diogo Rau was the Senior Director of Information Systems and Technology for retail and online stores at Apple Inc. from 2011 to 2021  **[0001193125-24-181268_d843899dex99a1a.htm:102]** **[0001193125-23-255631_d564373dex99a1a.htm:90]** .                                                                               |
| Daniel Skovronsky  | Executive Vice President, Chief Scientific Officer and President, Lilly Research Laboratories and Lilly Immunology | 2024 | Daniel Skovronsky has been with Lilly for 13 years, contributing significantly to the advancement of innovative medicines and the company's product pipeline  **[0001193125-24-181268_d843899dex99a1a.htm:102]** **[0000059478-24-000065_lly-20231231.htm:33]** .                                      |
| Jacob Van Naarden  | Executive Vice President and President, Loxo@Lilly                       | 2021               | Jacob Van Naarden joined Lilly in 2019 when the company acquired Loxo Oncology, Inc., where he was the Chief Operating Officer. He has served as Chief Executive Officer of Loxo Oncology at Lilly  **[0001193125-24-181268_d843899dex99a1a.htm:102]** **[0000059478-24-000065_lly-20231231.htm:33]** .                                      |
| Alonzo Weems       | Executive Vice President, Enterprise Risk Management, and Chief Ethics and Compliance Officer | 2021 | Alonzo Weems joined Lilly in **1997** and has held roles such as Vice President and Deputy General Counsel for Corporate Legal Functions from **2018 to 2021**. He is set to retire at the end of the year  **[0001193125-24-181268_d843899dex99a1a.htm:102]** **[0001193125-24-181268_d843899dex99a1a.htm:101]** . |
| Anne White         | Executive Vice President and President, Lilly Neuroscience               | 2021               | Anne White has been with Lilly since 1991 and has held roles such as senior vice president and president of Lilly Oncology from 2018 to 2021  **[0000059478-24-000065_lly-20231231.htm:33]** **[0001193125-23-183831_d266530dsc13d.htm:9]** .                                                                                            |
| Ilya Yuffa         | Executive Vice President and President, Lilly International              | 2021               | Ilya Yuffa has been with Lilly for **27 years** and has held roles such as senior vice president and president of Lilly Bio-Medicines from 2020 to 2021  **[0000059478-24-000065_lly-20231231.htm:33]** **[0001193125-23-255631_d564373dex99a1a.htm:90]** **[0001193125-23-186293_d497638dex99a1a.htm:99]** **[0001193125-23-180387_d459740dex99a1a.htm:89]** .                                                                          |
| Lucas Montarce     | Executive Vice President and Chief Financial Officer                     | 2024               | Lucas Montarce joined Lilly in 2001 and has held various finance leadership roles. He was elected as CFO on **September 9, 2024**  **[0000059478-24-000213_lly-20240905.htm:1]** .                                                                                                         |
| Jon Moeller        | Board Member                                                             | 2024               | Jon Moeller was elected as a new member of the Board of Directors, effective **December 1, 2024**. He is the Chairman of the Board, President, and CEO of Procter & Gamble  **[0000059478-24-000258_lly-20241119.htm:1]** **[0000059478-24-000258_pr_november2024.htm:0]** .                                                            |

5475d178e9f9a1c641759e32a2969ef5d264672452fc6fbf092954cd3a7d9e43

**Quarterly guidance for Q4 2024:**
- **Q4 year-over-year growth**: 50%    (no prior guidance)

**Annual guidance for FY 2024:**
- **Revenue**: $45.4 billion to $46.0 billion    (no change from $45.4 billion to $46.0 billion  **[LLY_3404651_3]** )  
- **Gross margin ratio**: unchanged    (no change from prior guidance  **[LLY_3404651_3]** )  
- **Other income and expense**: $425 million to $325 million of expense    (no change from prior guidance  **[LLY_3404651_3]** )  
- **Effective tax rate**: 17%    (no change from prior guidance  **[LLY_3404651_3]** )  
- **EPS**: $12.05 to $12.55 (reported) and $13.02 to $13.52 (non-GAAP)    (no change from prior guidance  **[LLY_3404651_3]** )

047e9dbfd6f31494c4512a861c66eb259b6a745f311384f331024f009325f861

87294f9cf981aadbbb30af6fb99262c449bb573e84d0ea9f72a76e88b144b26b

| Name             | Start Date | End Date | Reason for Change |
|------------------|------------|----------|-------------------|
| Ernst & Young LLP | 1940  **[0000059478-24-000065_lly-20231231.htm:150]**  | Present  | Current auditor   |

9765d6c6d16994fbd05a398e3d626d58dd2475e808ad6ee88f9194f9b16cf92e

ae330e516adbf2652712c5dc311718bc1b0b15099eb9e0eb180f29a4b6209734

d3b7e190d9c4824fe1dea8da94a96f6109f9787871b8ac2cbab037298996e33d

| Year | Amount Due (in Billions) | Debt Type               | Interest Rate (%) | % of Total Debt                                                                 |
|----------|------------------------------|-----------------------------|-----------------------|------------------------------------------------------------------------------------|
| 2026     | 0.750                        | Fixed-Rate Notes           | 5.000                | 2.4% = (0.750 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2027     | 1.750                        | Fixed-Rate Notes           | 4.150, 4.500         | 5.6% = (1.750 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2029     | 2.000                        | Fixed-Rate Notes           | 4.200, 4.500         | 6.4% = (2.000 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2033     | 1.000                        | Fixed-Rate Notes           | 4.700                | 3.2% = (1.000 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2034     | 2.750                        | Fixed-Rate Notes           | 4.600, 4.700         | 8.8% = (2.750 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2053     | 1.250                        | Fixed-Rate Notes           | 4.875                | 4.0% = (1.250 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2054     | 2.750                        | Fixed-Rate Notes           | 5.000, 5.050         | 8.8% = (2.750 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2063     | 1.000                        | Fixed-Rate Notes           | 4.950                | 3.2% = (1.000 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |
| 2064     | 2.250                        | Fixed-Rate Notes           | 5.100, 5.200         | 7.2% = (2.250 / 31.120) * 100 **[0000059478-24-000245_lly-20240930.htm:5]** **[0000059478-24-000245_lly-20240930.htm:22]**                                     |

c3db62f80ab7fc8a30003bcb43b803f688acb56fd6fd259f61bd22d92532df6f

a1547ef82a140728193b1912cf74b63ddafdd03320e9736031a1d729cfded1ab

- **Expansion into new indications for GLP-1 treatments like tirzepatide (Mounjaro/Zepbound)**: The company is exploring downstream opportunities in conditions such as NASH and other comorbidities, which could significantly increase the patient base and drive growth. Data generated in these areas will be critical for employer opt-in and access in Medicare Part D.  **[LLY_3371997_18]**
- **Development of an oral GLP-1 receptor agonist (orforglipron)**: With over **110 million** people with obesity in the U.S. and **650 million globally**, and considering that approximately **20%** of patients are concerned about injectables, an oral therapy like orforglipron could reach a larger patient population, offering efficacy comparable to the best competitive incretin therapies without food or water restrictions.  **[LLY_3371997_22]**
- **International expansion of Mounjaro**: The company is actively launching Mounjaro in several markets outside the U.S., including Australia, Canada, Germany, and Poland, and anticipates further launches throughout the year and into **2025**. This international growth strategy supports further revenue growth and market share gains in the GLP-1 space.  **[LLY_3371997_12]**

b7f55e36e183246b703aefcac9f6273898787fcb612223f651f5ac8beb625891

1. **Capacity Expansion and Guidance Raise**  
   **Q:** Explain the capacity dynamics leading to the guidance raise?  
   **A:** The company is ramping up capacity across multiple sites globally, including **six sites** under construction or ramping up in North Carolina, Indiana, Germany, and a recently purchased seventh site. Confidence in increased capacity supports the guidance raise. For example, the approval of the **Kwikpen in Europe** came slightly ahead of expectations, enhancing their ability to serve patients.  **[LLY_3381483_8]** 

2. **Mounjaro Pricing Trends**  
   **Q:** Comment on adverse pricing trends for Mounjaro?  
   **A:** In Q4, there was a significant **one-time adjustment** for Mounjaro. The **$25 savings card was terminated on June 30, 2023**, but patients already enrolled are grandfathered until June 30, 2024. While there may be some benefits in the first half of 2024, typical **pricing headwinds are expected** in the second half.  **[LLY_3381483_9]** **[LLY_3381483_10]** 

3. **Tirzepatide Part D Reimbursement**  
   **Q:** Will tirzepatide secure Part D reimbursement differently?  
   **A:** With CMS's early April announcement to reimburse obesity-related comorbidities based on the SELECT trial, the company is confident that new data, such as **sleep apnea**, will be reimbursed under **Medicare Part D**. They expect similar reimbursement for other comorbidities, assuming positive approvals.  **[LLY_3381483_11]** 

4. **Competitive Landscape for Zepbound**  
   **Q:** Thoughts on competitors' upcoming weight loss drugs?  
   **A:** While data on **Amgen's AMG 133** is limited, the company is interested in their results. **Novo Nordisk's CagriSema** adds more agonism on top of GLP-1, similar to their own **tirzepatide**, a dual agonist. They have advanced their **amylin agonist to Phase II** and believe tirzepatide currently has unsurpassed efficacy, while preparing next-generation assets.  **[LLY_3381483_13]** 

5. **SURPASS CVOT Confidence**  
   **Q:** Confidence in SURPASS CVOT achieving superiority?  
   **A:** The primary analysis focuses on **noninferiority** to **Trulicity**, a drug known to reduce cardiovascular risk. While avoiding specifics on interim analyses, the company remains increasingly confident in the readout. Additional data from the **OSA study** bolsters this confidence, highlighting benefits that could lead to cardiovascular advantages.  **[LLY_3381483_18]** 

6. **Tirzepatide and Retatrutide in NASH**  
   **Q:** Thoughts on tirzepatide's NASH data and next steps?  
   **A:** The **Phase II NASH data** for tirzepatide is exciting, showing a profound effect on the disease. The full data will be presented at **EASL in early June**. Discussions with the FDA will determine the best path forward. They also have **retatrutide**, which may offer additional liver benefits due to its glucagon component, providing options in addressing NASH.  **[LLY_3381483_12]** 

7. **Lepodisiran Phase III and Differentiation**  
   **Q:** How will lepodisiran differentiate in Phase III?  
   **A:** While Phase II data isn't published yet, **Phase I data** showed a **long-lasting and deep reduction** in **Lp(a)** levels after a single dose. Potential differentiation includes greater depth of Lp(a) clearance, frequency and durability of administration, and studying both **secondary and primary prevention** populations.  **[LLY_3381483_17]** 

8. **Amylin Agonist Development**  
   **Q:** Why advance amylin over GIP agonists for obesity?  
   **A:** While GIP agonism is effective and included in tirzepatide, the company is exploring **long-acting amylin**, which has moved to **Phase II**. Amylin represents another mechanism to enhance treatment and may serve as combination therapy, maintenance therapy, or monotherapy. It's early, but they're investing in multiple mechanisms to improve patient outcomes.  **[LLY_3381483_15]** 

9. **Zepbound CMS Coverage Expectations**  
   **Q:** Will Zepbound get CMS coverage like Wegovy?  
   **A:** Based on CMS's April announcement, they expect **obstructive sleep apnea** for Zepbound to be covered under **Medicare** at launch. Next would be broader coverage pending positive **heart failure data** and approvals, followed by other indications as planned.  **[LLY_3381483_16]** 

10. **Tirzepatide Prescription Data Accuracy**  
    **Q:** Is IQVIA data accurately representing tirzepatide volumes?  
    **A:** While **Lilly Direct** volumes are relatively low and may not be fully captured by IQVIA, the data provider has methodologies to estimate this channel. Utilization of Lilly Direct is increasing weekly, but any underrepresentation in IQVIA data is minimal at this stage.  **[LLY_3381483_14]** 

11. **Kwikpen Use in U.S.**  
    **Q:** Why not use Kwikpen in U.S. to relieve capacity?  
    **A:** **Kwikpen** utilizes existing assets and was introduced in the UK and Europe to meet patient needs more quickly due to less time lag. While not currently used in the U.S., they haven't ruled it out and are exploring all options to meet high demand and address supply constraints globally.  **[LLY_3381483_16]** 

0156d808d5c22352ddf085d9757cf38b149ff91ee2482c58d13ae3d5e2684e76

- **Reimbursement challenges for new indications like sleep apnea:** Despite promising data, there is uncertainty around reimbursement for tirzepatide's new indications under Medicare Part D, as policies may not pass in 2024.  **[LLY_3381483_11]**
- **Limitations and side effects of leading drug tirzepatide:** Even though tirzepatide is effective, some patients experience gastrointestinal side effects, and not all achieve desired weight loss levels, leaving room for improvement and potential competition.  **[LLY_3381483_21]**
- **Uncertainties in early-stage pipeline drugs:** Many of Lilly's obesity drugs in development, such as bimagrumab and amylin receptor agonists, are in early stages with unclear efficacy and differentiation, posing risks to future growth.  **[LLY_3381483_23]** ,  **[LLY_3381483_15]**

f567d3a05731e9fab32657d5179b5b1a9eee27f66220cd4ff17bf33a9571b1e5

- **Payer access issues:** Some employers are opting out of coverage for obesity medications, which could limit market growth for **Zepbound**, despite close to **90% commercial access**.  **[LLY_3404651_13]**
- **Potential impact of the Inflation Reduction Act (IRA):** The IRA's Part D reforms could affect products like **Verzenio**, and inclusion in price negotiations may impact profitability, although the exact impact is uncertain.  **[LLY_3404651_18]**
- **Competition from compounded drugs:** Compounded versions of incretin medicines could impact demand for Lilly's products, and the FDA's stance on enforcing regulations adds uncertainty to the market.  **[LLY_3404651_21]**

0541b0cdcfda56275773bae23fe2e256687c9f12b89556b299657dd92e9da945

- **Lilly's OGA inhibitor for Alzheimer's disease failed to meet the primary endpoint in Phase II trials**, resulting in a negative outcome for their neuroscience pipeline.  **[LLY_3397445_8]** **[LLY_3397445_7]**
- **The company anticipates supply constraints and variability in patient experience due to complex supply chain issues**, which may result in periodic tightness for certain products and potentially impact sales.  **[LLY_3397445_17]**
- **Operating margins may decrease as Lilly plans to increase spending on promotional activities and R&D**, which could affect future profitability.  **[LLY_3397445_20]**

923da8caf7e37663bd277123805a8e3508a19653dda016c96d57b2a58c049eca

- **Eli Lilly's Phase II data for tirzepatide in NASH showed profound effect size**, and the company is excited about the opportunity to help patients suffering from NASH. They are working on non-invasive biomarkers that could be suitable for accelerated approval, potentially leading to a significant new market.  **[LLY_3397445_6]**
- **Mounjaro and Zepbound are experiencing an inflection point upwards**, which is leading Eli Lilly to reach the **upper end of its operating margin range** (mid- to high 30% range). This indicates strong operating leverage and financial performance.  **[LLY_3397445_16]**
- **Eli Lilly expects stronger sales and marketing growth in the second half of 2024** due to new product launches and increased promotional activities, which should **further enhance revenue and profitability**.  **[LLY_3397445_16]**

509b5af989fff34eb93bad2ed26b23f5e05ea127b70374b540cd874e029472d2

- **Eli Lilly anticipates Medicare Part D reimbursement for tirzepatide (Mounjaro/Zepbound) due to new indications like obstructive sleep apnea**, potentially expanding patient access and driving revenue growth.  **[LLY_3381483_11]**
- **Eli Lilly has a robust pipeline of next-generation obesity treatments**, including nine assets in Phase I and II, aiming to improve upon current drugs like tirzepatide and strengthen their leadership in metabolic diseases.  **[LLY_3381483_21]** **[LLY_3381483_13]** **[LLY_3381483_15]** **[LLY_3381483_12]**
- **Eli Lilly is confident in its manufacturing capacity to meet future global demand for orforglipron**, their oral GLP-1 receptor agonist, potentially offering advantages in production scalability over injectable treatments.  **[LLY_3381483_20]**

73dc3ae03e4614731a129dad445c506374d4511d7fda8ff935a270504ad5555b

1. **Investment in Orforglipron Manufacturing**  
   **Q:** How are you balancing investment in capacity with orforglipron's probabilities?  
   **A:** We're investing fully to create new capacities  **[LLY_3371997_15]** , building ahead of Phase III for orforglipron at risk due to its potential.  **[LLY_3371997_15]** 

2. **Opportunity for Oral GLP-1s**  
   **Q:** How do you view the opportunity for oral GLP-1s like orforglipron?  
   **A:** With over **110 million** obese in the U.S.  **[LLY_3371997_22]** , injectables can't reach all; orforglipron offers an oral option with competitive weight loss and no food restrictions  **[LLY_3371997_22]** , appealing to patients reluctant to use injectables.  **[LLY_3371997_22]** 

3. **Manufacturing Capacity Strategies**  
   **Q:** Will you buy rather than build to overcome manufacturing bottlenecks?  
   **A:** We're not capital-constrained, but existing capacity isn't available  **[LLY_3371997_28]** ; building new capacity takes **3-4 years**, so buying doesn't solve immediate needs  **[LLY_3371997_28]** ; over time capacity will increase, and new technologies like orforglipron will help.  **[LLY_3371997_28]** 

4. **Impact of Novo's Acquisition of Catalent**  
   **Q:** Does Novo's acquisition of Catalent impact your supply strategy?  
   **A:** We have questions about the transaction and need to learn more  **[LLY_3371997_27]** ; our focus is on ensuring uninterrupted supply and holding Catalent accountable to contracts.  **[LLY_3371997_27]** 

5. **Future Plans for Tirzepatide in NASH**  
   **Q:** Why hasn't Lilly initiated a Phase III trial of tirzepatide in NASH?  
   **A:** We just received positive Phase II data and are determining next steps  **[LLY_3371997_23]** ; nothing in the data prevents us from proceeding, but we may have better molecules like retatrutide.  **[LLY_3371997_23]** 

6. **SYNERGY-NASH Trial Prospects**  
   **Q:** Is there a prospect for accelerated approval from SYNERGY-NASH?  
   **A:** We're excited about the promising data from a small trial (**190 participants**) showing clinically meaningful improvement in fibrosis  **[LLY_3371997_14]** , and we look forward to discussing next steps with the FDA.  **[LLY_3371997_14]** 

7. **SURPASS-CVOT Trial Timing**  
   **Q:** Does the delay in SURPASS-CVOT imply interim results, and is superiority needed?  
   **A:** We don't comment on interims; the delay is due to slower event rates, which is good for patients.  **[LLY_3371997_16]**  Superiority would be beneficial, but we remain focused on the trial's completion.  **[LLY_3371997_16]** 

8. **GIP Agonism vs. Antagonism**  
   **Q:** How do you view GIP agonism versus antagonism?  
   **A:** We're extremely confident in the benefits of GIP agonism based on extensive data  **[LLY_3371997_26]** ; antagonism may have negative effects like increased free fatty acids  **[LLY_3371997_26]** , while agonism may improve tolerability.  **[LLY_3371997_26]** 

9. **Zepbound Payer Coverage Expansion**  
   **Q:** Will most payers who cover Wegovy add Zepbound this year?  
   **A:** We have **35%** commercial access early in launch  **[LLY_3371997_13]** , aiming to expand to levels similar to competitors, around **50%**.  **[LLY_3371997_13]** 

10. **International GLP-1 Launch Expansion**  
    **Q:** What are the hurdles to closing the ex-U.S. gap in your GLP-1 franchise?  
    **A:** We've launched Mounjaro in markets like Australia, Canada, Germany, and Poland  **[LLY_3371997_12]** , received QuickPen approval in the U.K.  **[LLY_3371997_12]** , and will continue launching as we get approvals and increase supply capacity throughout this year and into **2025**.  **[LLY_3371997_12]** 

11. **Lean Muscle Loss and Tirzepatide**  
    **Q:** What's Lilly's take on lean muscle loss with tirzepatide vs. semaglutide?  
    **A:** Tirzepatide improves lean-to-fat mass ratio, losing more fat than lean mass  **[LLY_3371997_21]** ; the ratios you mentioned seem correct, possibly due to GIP agonism benefits.  **[LLY_3371997_21]** 

12. **Duration of GLP-1 Therapy Use**  
    **Q:** Any updates on duration of GLP-1 use in diabetes and obesity patients?  
    **A:** It's still early, but Mounjaro shows encouraging persistency similar to other injectable incretins  **[LLY_3371997_24]** ; too early to gauge for Zepbound.  **[LLY_3371997_24]** 

13. **Extended Dosing and Sustainability**  
    **Q:** What's your view on extended dosing like monthly administration and sustained efficacy off-therapy?  
    **A:** The data on extended dosing and sustained efficacy are underwhelming  **[LLY_3371997_29]** ; weight loss is lower than needed for Phase III  **[LLY_3371997_29]** ; convenience matters but isn't the most important factor for providers and patients.  **[LLY_3371997_29]** 

14. **Downstream Opportunities for GLP-1 Therapies**  
    **Q:** How are you sizing downstream opportunities for tirzepatide in NASH and other indications?  
    **A:** Key drivers are increased employer opt-in and access in Medicare Part D, supported by data in comorbidities like cardiovascular and NASH.  **[LLY_3371997_18]** 

15. **Orforglipron Safety and DDI Profile**  
    **Q:** What do you mean by orforglipron having lots to prove, and will it work with SGLT2s?  
    **A:** As we're starting Phase III, we need to confirm safety  **[LLY_3371997_25]** ; we expect coadministration with SGLT2s to be possible and have it ongoing in trials.  **[LLY_3371997_25]** 

16. **Tirzepatide in Sleep Apnea**  
    **Q:** How much benefit is needed in sleep apnea for clinical meaningfulness?  
    **A:** There's no established threshold, but we're optimistic about tirzepatide's potential and will assess various measures to determine clinical meaningfulness.  **[LLY_3371997_17]** 

17. **Purpose of Lilly Direct Platform**  
    **Q:** Is Lilly Direct just to streamline access, or is there a monetization model?  
    **A:** Lilly Direct aims to streamline access for patients and serve them better  **[LLY_3371997_20]** , not intended as a new retail distribution business.  **[LLY_3371997_20]** 

18. **Tirzepatide Branding Outside the U.S.**  
    **Q:** Why not launch Zepbound outside the U.S. but expand Mounjaro's label?  
    **A:** Branding decisions depend on regulatory, competitive, and payer dynamics  **[LLY_3371997_19]** ; we're optimistic about commercialization under different brand scenarios.  **[LLY_3371997_19]** 

d21f0f2aaeeeaf2b42a0d8a1ec4139e40e03e7fbbd29dd21735d1662780a0a25

1. **Supply and Demand Dynamics**  
   **Q:** What's driving the acceleration from Q3 to Q4 sales?  
   **A:** Sales are expected to accelerate in Q4 due to increased investments in direct-to-consumer efforts and healthcare provider promotions, as supply constraints have eased. We are confident in continued growth for Mounjaro and Zepbound, projecting a midpoint of **50% growth** in Q4 compared to **42%** prior, even exceeding that as we enhance demand-generating activities. This acceleration is supported by both U.S. demand and new country launches.  **[LLY_3404651_9]** 

2. **Supply Capacity Expansion**  
   **Q:** How is supply capacity progressing for 2025?  
   **A:** We are bringing online capacities announced in 2021-2023, expecting significant growth next year. Investments from previous years are coming to fruition, enabling increased supply of auto-injectors. We see acceleration in demand and anticipate strong growth, aligning with our capacity expansion efforts.  **[LLY_3404651_14]** 

3. **Compounding Impact**  
   **Q:** Is compounding affecting demand and FDA's stance?  
   **A:** We do not estimate a significant financial impact from compounded drugs on our business. Our major concern is patient safety, as unapproved medications pose risks. We believe the FDA is aware of the regulatory risks and is working to address the issue. We continue to collaborate with the FDA to expedite legitimate product delivery.  **[LLY_3404651_11]** **[LLY_3404651_12]** 

4. **Access and Payer Restrictions**  
   **Q:** How are access issues affecting growth into 2025?  
   **A:** For Mounjaro, we have **93% access** across commercial and Medicare plans. With Zepbound, we've achieved close to **90% commercial access**. While some employers opt out, the overall trend favors opting in. We are optimistic about improved access in 2025, with continued progress in Medicaid—gaining six incremental states, including California and Massachusetts. Potential approvals in sleep apnea and other indications will further enhance employer opt-in and Medicare access.  **[LLY_3404651_13]** 

5. **Operating Margin Outlook**  
   **Q:** Clarify the operating margin trajectory under your guidance.  
   **A:** In the short term, we have grown our ratio due to significant growth and are ramping up investments in SG&A and R&D, which will continue into Q4 and 2025. We expect operating margin expansion in the short term, while justifying investments that drive long-term sustainable growth.  **[LLY_3404651_19]** 

6. **Direct-to-Consumer Advertising**  
   **Q:** Why initiate DTC advertising for Zepbound now?  
   **A:** With supply constraints easing, we are investing in DTC efforts to drive consumer awareness. Despite strong performance, obesity treatment penetration remains at a low **4–5%**, indicating substantial growth potential. Increasing patient activation will serve us well. Unaided awareness for Zepbound is not very high, as we have done no advertising since launch nearly a year ago.  **[LLY_3404651_16]** 

7. **Parasolimab Discontinuation**  
   **Q:** Why discontinue parasolimab development, and plans for a new PD-1 agonist?  
   **A:** The Phase IIb study for parasolimab did not replicate the benefit-risk seen in Phase IIa. Based on the overall profile, including efficacy and safety, we decided not to pursue it further. Currently, we are not pursuing another PD-1 agonist for immunology and inflammation.  **[LLY_3404651_17]** 

8. **Verzenio's Market Share and IRA Impact**  
   **Q:** How will you protect Verzenio's position given competitor approvals and IRA impact?  
   **A:** Our expectations for Verzenio's market share in the adjuvant setting remain unchanged due to robust clinical data and treatment guideline preferences for high-risk patients. Part D reform may have a neutral net impact, balancing increased catastrophic coverage contributions and patient out-of-pocket caps. It's too early to speculate on inclusion in the negotiation list for 2027.  **[LLY_3404651_18]** 

9. **Obesity Market Expansion with Orforglipron**  
   **Q:** How will orforglipron expand the obesity market?  
   **A:** We see significant opportunity with orforglipron as the first oral treatment matching injectable efficacy, allowing for global scaling by avoiding cold chain requirements and addressing needle aversion in **20–25%** of patients. We aim to expand treatment duration understanding through trials like ATTAIN-MAINTAIN, recognizing obesity as a chronic disease needing long-term management.  **[LLY_3404651_21]** 

10. **Pricing Evolution**  
    **Q:** What's the outlook on pricing for Mounjaro and Zepbound?  
    **A:** For Mounjaro, as we sunset last year's co-pay program, we see expected tailwinds on price year-over-year, stabilizing into Q4. With Zepbound, pricing remains stable, but increasing access and global launches may impact net pricing dynamics moving forward.  **[LLY_3404651_20]** 

52b5f56d46ae5ccb0520c52db55fe6de221846fd7f6c3c1fe2f6bc42eb24e0e7

1. **Operating Margins Outlook**  
   **Q:** Will margins exceed 40% mid-term?  
   **A:** Lilly expects to end this year with operating margins in the **upper 30% range**.  **[LLY_3397445_20]**  While revenue is increasing due to strong sales, expenses in promotional channels and R&D are also rising. Longer-term margin projections will be discussed when 2025 guidance is provided.  **[LLY_3397445_20]** 

2. **Competition in Obesity Market**  
   **Q:** How will Lilly defend against new obesity competitors?  
   **A:** Lilly acknowledges the influx of emerging competitors but highlights significant barriers to entry. Success requires advancing drugs through Phase III trials and securing approvals, which is challenging.  **[LLY_3397445_12]**  Lilly is investing heavily in indications and access, boasting **93% commercial access** for Mounjaro and **83%** for Zepbound within seven months.  **[LLY_3397445_12]**  The company is confident in its robust pipeline and market position.

3. **Manufacturing Capacity and Supply**  
   **Q:** What's the status of manufacturing progress?  
   **A:** Lilly reiterates the **1.5-fold increase** in sellable doses as a floor for second-half volume.  **[LLY_3397445_11]**  The introduction of vials will add capacity, with the most meaningful impact in early 2025.  **[LLY_3397445_11]**  Progress at RTP and Concord manufacturing sites is on track, expected to produce product by year-end or early next year.  **[LLY_3397445_11]** 

4. **Ex-U.S. Sales and Reimbursement**  
   **Q:** How are ex-U.S. incretin sales performing?  
   **A:** Mounjaro's ex-U.S. sales grew to **$677 million** from **$286 million**.  **[LLY_3397445_22]**  The growth is driven by strong launches in markets like the UK, UAE, and Saudi Arabia, achieving leading market shares.  **[LLY_3397445_15]**  Reimbursement has been secured in the UK and Germany, with both reimbursed and out-of-pocket sales contributing to momentum.  **[LLY_3397445_22]** 

5. **Compounded GLP-1 Safety Concerns**  
   **Q:** What is Lilly doing about compounded GLP-1s?  
   **A:** Lilly is concerned about patient safety from compounded GLP-1 products, which often are not tirzepatide and may contain impurities or contaminants.  **[LLY_3397445_13]**  The company is engaging with regulators and considering legal actions, emphasizing the risks to patients and the importance of scaling manufacturing to meet demand.  **[LLY_3397445_13]** 

6. **Muscle-Preserving Obesity Drugs**  
   **Q:** How important are muscle-preserving obesity drugs?  
   **A:** Lilly finds this an interesting area of science but notes it's too early to predict patient benefits.  **[LLY_3397445_23]**  The company is exploring multiple mechanisms, including amylin agonists and myostatin antibodies, to potentially preserve lean mass during weight loss.  **[LLY_3397445_21]** 

7. **Engagement in NASH Trials**  
   **Q:** Plans for pivotal NASH trials?  
   **A:** Lilly is excited about helping NASH patients and is in discussions with regulators about potential pivotal trials.  **[LLY_3397445_16]**  Challenges include the invasive nature of liver biopsies, and the company is working on non-invasive biomarkers. Decisions on investing in one or both molecules will depend on the regulatory path.  **[LLY_3397445_16]** 

8. **Pricing Dynamics and ASP Movements**  
   **Q:** What are the pricing trends for Mounjaro?  
   **A:** Initial pricing favorability driven by Mounjaro's co-pay program in the first half will diminish in the second half.  **[LLY_3397445_10]**  Pricing is expected to remain stable sequentially across quarters in 2024, with second-half pricing similar to the prior year.  **[LLY_3397445_10]** 

9. **FDA Shortage Definition**  
   **Q:** Does Lilly agree tirzepatide is no longer in shortage?  
   **A:** Lilly agrees that tirzepatide is now available in all dosage forms in the U.S. and can fill orders as received.  **[LLY_3397445_23]**  While not every pharmacy may have all doses in stock at all times, the company continues to work with partners to improve the consumer experience.  **[LLY_3397445_23]** 

10. **Manufacturing Concerns with Catalent**  
    **Q:** Are you still concerned about Novo's acquisition of Catalent?  
    **A:** Lilly remains concerned about the transaction, highlighting the conflict of having a main competitor also be a contract manufacturer.  **[LLY_3397445_17]**  The company emphasizes the importance of independent CDMOs for the industry and notes that their primary strategy is to build and operate their own sites.  **[LLY_3397445_17]** 

11. **Persistence with Zepbound Therapy**  
    **Q:** How is Lilly encouraging persistence with Zepbound?  
    **A:** Lilly focuses on ensuring patients experience the benefits of Zepbound over time.  **[LLY_3397445_18]**  Efforts include improving consumer platforms, digital channels, and value-based agreements with payers to demonstrate benefits like reduced absenteeism and increased productivity.  **[LLY_3397445_18]** 

12. **Oral GLP-1 Mechanisms**  
    **Q:** Basis of competition for oral GLP-1s?  
    **A:** Lilly expects that efficacy among oral GLP-1 agonists will be similar, with tolerability being a key differentiator.  **[LLY_3397445_19]**  Longer half-life molecules may offer better tolerability. Lilly is developing next-generation molecules, including those combining multiple incretins.  **[LLY_3397445_19]** 

3a2b0b7d560e9da27fb8ca0379aaea0d5f271fd046cf7b0c19c62ee3d1453972

Eli Lilly and Co (LLY)

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