Amgen Inc. is a global biotechnology company that discovers, develops, manufactures, and delivers innovative medicines to address serious diseases **[0000318154-24-000011_amgn-20231231.htm:107]**. The company operates in the human therapeutics segment, focusing on areas of high unmet medical need **[0000318154-24-000044_amgn-20240930.htm:32]**. Amgen's principal products include Prolia, ENBREL, XGEVA, Repatha, Otezla, TEPEZZA, EVENITY, KYPROLIS, Nplate, Aranesp, KRYSTEXXA, BLINCYTO, Vectibix, and TEZSPIRE, among others **[0000318154-24-000035_amgn-20240630.htm:32]**. The company's strategy includes expanding its rare disease portfolio, bolstered by the acquisition of Horizon Therapeutics **[0001193125-24-099062_d445034ddef14a.htm:9]**.

1. **Human Therapeutics** - Focuses on developing and delivering medicines for serious diseases, with key products like Prolia, ENBREL, XGEVA, Repatha, and Otezla driving growth.
   - **Prolia** - Treats osteoporosis by increasing bone mass and strength.
   - **ENBREL** - Used for treating autoimmune diseases such as rheumatoid arthritis.
   - **XGEVA** - Prevents skeletal-related events in patients with bone metastases.
   - **Repatha** - Lowers cholesterol levels in patients with cardiovascular risks.
   - **Otezla** - Treats moderate to severe plaque psoriasis and psoriatic arthritis.
2. **Rare Disease Portfolio** - Expanded through the acquisition of Horizon Therapeutics, focusing on rare diseases with products like TEPEZZA, KRYSTEXXA, and UPLIZNA.
   - **TEPEZZA** - Treats thyroid eye disease.
   - **KRYSTEXXA** - Manages chronic gout in adult patients.
   - **UPLIZNA** - Targets neuromyelitis optica spectrum disorder.
3. **Oncology and Hematology** - Develops treatments for cancer and blood disorders, including products like KYPROLIS, Nplate, Aranesp, and BLINCYTO.
   - **KYPROLIS** - Used in the treatment of multiple myeloma.
   - **Nplate** - Increases platelet production in patients with chronic immune thrombocytopenia.
   - **Aranesp** - Treats anemia associated with chronic kidney disease and chemotherapy.
   - **BLINCYTO** - Engages the immune system to target and destroy leukemia cells.
4. **Bone Health** - Offers treatments like EVENITY and Vectibix to improve bone health and treat bone-related conditions.
   - **EVENITY** - Increases bone formation and reduces the risk of fractures in osteoporosis.
   - **Vectibix** - Used in the treatment of metastatic colorectal cancer.
5. **Respiratory and Inflammatory Diseases** - Provides solutions for respiratory and inflammatory conditions, with products like TEZSPIRE.
   - **TEZSPIRE** - Treats severe asthma by targeting inflammatory pathways.

8e621eb08db5b3db600b59dea11297761ece354c2d3393ccae0069ce2e08f571

| Metric [Unit: $ Million] | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|--------------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| U.S. Revenue             | **4,794**  **[0000318154-23-000011_amgn-20221231earningsrelea.htm:5]**  | **3,975**  **[0000318154-23-000029_amgn-20230331.htm:8]**  | **4,736**  **[0000318154-23-000049_amgn-2023630earningsrelease.htm:3]**  | **4,691**  **[0000318154-23-000064_amgn-20230930.htm:9]**  | **5,870**  **[0000318154-24-000004_amgn-20231231earningsrelea.htm:4]**  | **4,973**  **[0000318154-24-000018_amgn-20240331earningsrelea.htm:2]**  | **5,840**  **[0000318154-24-000033_amgn-20240630earningsrelea.htm:2]**  | **5,979**  **[0000318154-24-000042_amgn-20240930earningsrelea.htm:2]**  |
| ROW Revenue              | **1,758**  **[0000318154-23-000011_amgn-20221231earningsrelea.htm:5]**  | **1,871**  **[0000318154-23-000029_amgn-20230331.htm:8]**  | **1,947**  **[0000318154-23-000049_amgn-2023630earningsrelease.htm:3]**  | **1,857**  **[0000318154-23-000064_amgn-20230930.htm:9]**  | **1,960**  **[0000318154-24-000004_amgn-20231231earningsrelea.htm:4]**  | **2,145**  **[0000318154-24-000018_amgn-20240331earningsrelea.htm:2]**  | **2,201**  **[0000318154-24-000033_amgn-20240630earningsrelea.htm:2]**  | **2,172**  **[0000318154-24-000042_amgn-20240930earningsrelea.htm:2]**  |
| Total Revenue            | **6,552**  **[0000318154-23-000011_amgn-20221231earningsrelea.htm:5]**  | **5,846**  **[0000318154-23-000029_amgn-20230331.htm:8]**  | **6,683**  **[0000318154-23-000049_amgn-2023630earningsrelease.htm:3]**  | **6,548**  **[0000318154-23-000064_amgn-20230930.htm:9]**  | **8,200**  **[0000318154-24-000004_amgn-20231231earningsrelea.htm:4]**  | **7,118**  **[0000318154-24-000018_amgn-20240331earningsrelea.htm:2]**  | **8,041**  **[0000318154-24-000033_amgn-20240630earningsrelea.htm:2]**  | **8,151**  **[0000318154-24-000042_amgn-20240930earningsrelea.htm:2]**  |

b791bead8e574cd37ba869d1e1d5fb6cfa04f15ffa1c97dc693bf44f87e4319c

Adjustments for Non-Cash Items [USD, Millions]

Stock-Based Compensation [USD, Millions]

Changes in Working Capital [USD, Millions]

Capital Expenditures (CapEx) [USD, Millions]

Proceeds from / Repayments of Debt [USD, Millions]

Share Repurchases [USD, Millions]

Dividend Payments [USD, Millions]

Net Change in Cash [USD, Millions]

04aa83f81211f40810baeb7a5e12047ba5529c8eef16e4bd9fa3e3638f2a439d

b7d712a969bda05956e7e7a2837dd994bda68548cdd44a0030170b3c4278e703

1. **Non-GAAP operating expenses increased 30% year-over-year, driven by higher R&D and SG&A spending, including investments in Repatha, Otezla, and EVENITY. How do you plan to manage these increasing expenses to maintain your operating margin, and when do you expect to see a return on these investments?**

2. **The Horizon acquisition resulted in a $700 million OI&E expense, up $400 million year-over-year due to increased interest expenses. Can you elaborate on your deleveraging plan to retire over $10 billion of debt by the end of 2025, and how this will impact your financial flexibility and capital allocation priorities?**

3. **With Enbrel facing competition in a crowded market and the CMS price negotiations concluding with a price reduction affecting approximately 25% of its revenues from Medicare Part D, what strategies are you implementing to sustain Enbrel's performance, and how are you mitigating the potential impact of Part D redesign on its future sales?**

4. **You are significantly ramping up investment in your late-stage pipeline, including MariTide for obesity and Type 2 diabetes, and rocatinlumab for atopic dermatitis. Given the competitive landscape in these areas, how confident are you in the potential success of these programs, and what differentiates your candidates from existing therapies?**

5. **Despite the strong initial uptake of IMDELLTRA since its mid-May launch, what challenges do you anticipate in its adoption, given the need for monitoring and establishing new care pathways, and how do you plan to address these to maximize its market potential?**

a8ca45ab52d3196273828cbb94740f8850d7d9cc90db4f92d691ee2b43dbc0be

### Q3 2024 Earnings Call
- **Issued Period**: Q3 2024
- **Guided Period**: N/A (The documents do not provide specific guidance from the Q3 2024 earnings call.)

### Q2 2024 Earnings Call
- **Issued Period**: Q2 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Total Revenues**: $32.8 billion to $33.8 billion  **[AMGN_3396666_11]** .
  2. **Non-GAAP EPS**: $19.10 to $20.10  **[AMGN_3396666_11]** .
  3. **Non-GAAP R&D Expenses**: Increase more than 25% year-over-year  **[AMGN_3396666_12]** .
  4. **Non-GAAP Operating Margin**: Roughly 47% as a percentage of product sales  **[AMGN_3396666_12]** .
  5. **OI&E**: Approximately $2.5 billion  **[AMGN_3396666_12]** .
  6. **Non-GAAP Tax Rate**: 15% to 16%  **[AMGN_3396666_12]** .
  7. **Capital Expenditures**: $1.3 billion  **[AMGN_3396666_12]** .

### Q1 2024 Earnings Call
- **Issued Period**: Q1 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Total Revenues**: $32.5 billion to $33.8 billion  **[AMGN_3382225_11]** .
  2. **Non-GAAP EPS**: $19 to $20.20  **[AMGN_3382225_11]** .
  3. **Non-GAAP R&D Expenses**: Increase by approximately 25% year-over-year  **[AMGN_3382225_11]** .
  4. **Non-GAAP Operating Expenses**: Growth rate comparable to Q1 over Q2 and Q3, with normalization in Q4  **[AMGN_3382225_11]** .
  5. **Operating Margin**: Expected to improve over the next three quarters  **[AMGN_3382225_11]** .
  6. **OI&E**: Roughly $2.6 billion  **[AMGN_3382225_11]** .
  7. **Non-GAAP Tax Rate**: 15% to 16%  **[AMGN_3382225_11]** .
  8. **Capital Expenditures**: Approximately $1.1 billion  **[AMGN_3382225_11]** .
  9. **Full Year Sales of MariTide**: Approximately $500 million  **[AMGN_3382225_11]** .

### Q4 2023 Earnings Call
- **Issued Period**: Q4 2023
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Total Revenues**: $32.4 billion to $33.8 billion  **[AMGN_3372061_12]** .
  2. **Non-GAAP EPS**: $18.90 to $20.30  **[AMGN_3372061_12]** .
  3. **Other Revenue**: Approximately $1.3 billion to $1.4 billion  **[AMGN_3372061_12]** .
  4. **Non-GAAP R&D Expenses**: Increase by approximately 25% year-over-year  **[AMGN_3382225_11]** .
  5. **Operating Margin**: Expected to improve over the next three quarters  **[AMGN_3382225_11]** .
  6. **OI&E**: Roughly $2.6 billion  **[AMGN_3382225_11]** .
  7. **Non-GAAP Tax Rate**: 15% to 16%  **[AMGN_3382225_11]** .
  8. **Capital Expenditures**: Approximately $1.1 billion  **[AMGN_3382225_11]** .
  9. **Share Repurchases**: Expected to exceed $500 million  **[AMGN_3372061_14]** .
  10. **Dividend**: Expectation to continue increasing the dividend  **[AMGN_3372061_14]** .

97f4828cdd75262425b9cd9e395aec16e50a45896a171fec0941f88a2fe5ea49

b0c8cba623d1ca1635647077e7dbcf66299d6bdfdf9713773448a18104186a81

- Various: Competitors for Prolia in the U.S., Europe, and Asia Pacific include bisphosphonates, including generics  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- AbbVie: Competitor for ENBREL in the U.S. with HUMIRA and RINVOQ, and for Otezla in the U.S. and Europe with HUMIRA and Skyrizi  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Pfizer Inc.: Competitor for ENBREL in the U.S. with Xeljanz, and for BLINCYTO in the U.S. and Europe with BESPONSA  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Various: Competitors for ENBREL in Canada with etanercept biosimilars, and for XGEVA in the U.S. and Europe with zoledronate generics  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Novartis: Competitor for Otezla in the U.S. and Europe with Cosentyx, for Nplate in the U.S. and Europe with PROMACTA/REVOLADE, and for Repatha in the U.S. and Europe with LEQVIO  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Lilly: Competitor for Otezla in the U.S. and Europe with Taltz, and for Vectibix in the U.S. and Europe with ERBITUX  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Janssen (a subsidiary of Johnson & Johnson): Competitor for Otezla in the U.S. and Europe with Tremfya, for KYPROLIS in the U.S. and Europe with DARZALEX, and for Aranesp in the U.S. with PROCRIT  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Bristol Myers Squibb (BMS): Competitor for Otezla in the U.S. and Europe with SOTYKTU, and for KYPROLIS in the U.S. and Europe with POMALYST/IMNOVID  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Various: Competitors for Otezla in the U.S. and Europe with topical products, and for Vectibix in the U.S. and Europe with chemotherapy regimes  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Regeneron Pharmaceuticals, Inc. and Sanofi: Competitors for Repatha in the U.S., Europe, and Asia Pacific with PRALUENT  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Millennium Pharmaceuticals, Inc. (a subsidiary of Takeda Pharmaceutical Company Limited): Competitor for KYPROLIS in the U.S. with VELCADE  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Various: Competitors for KYPROLIS in the U.S. and Europe with REVLIMID (including generics)  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Asahi Kasei Pharma: Competitor for EVENITY in Japan with Teribone  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- F. Hoffmann-La Roche Ltd (Roche): Competitor for Vectibix in the U.S. and Europe with Avastin  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Merck & Co., Inc.: Competitor for Vectibix in the U.S. with KEYTRUDA  **[0000318154-24-000011_amgn-20231231.htm:15]** .
- Sandoz Inc., Sandoz GmbH, Lek Pharmaceuticals d.d., Novartis Pharmaceutical Productions d.o.o., and Novartis AG: Competitors involved in litigation regarding biosimilar versions of Amgen's Prolia and XGEVA products  **[0000318154-24-000011_amgn-20231231.htm:225]** .

225de941228167081805340ceae6fd63f5ea661289bdb5300913f434926f740e

Total Revenue [USD, Millions]

Cost of Goods Sold (COGS) [USD, Millions]

SG&A [USD, Millions]

R&D [USD, Millions]

D&A [USD, Millions]

Interest Expense [USD, Millions]

Operating Income (EBIT) [USD, Millions]

Net Income [USD, Millions]

EPS - Basic [USD, Per Share]

EPS - Diluted [USD, Per Share]

6e84255a6d5a9e518d33b6fb356db9d6663d1cff37e73fd71e684779f9d192ef

23794d91c53ae875c8e247d72561e35d9d06ee07c70c9e0dbcc977a6d161504a

| Name               | Position                                                                 | Start Date | Short Bio                                                                                                                                                                                                                                                                                                                                 |
|--------------------|--------------------------------------------------------------------------|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Robert A. Bradway | Chief Executive Officer and President                                     | 2012       | Robert A. Bradway has been a director of Amgen since **2011** and has served as Chairman of the Board since **2013**. He became the company's President in **2010** and Chief Executive Officer in **2012**. Before these roles, he served as Amgen's Chief Operating Officer from **2010 to 2012**. Mr. Bradway joined Amgen in **2006** as Vice President, Operations Strategy  **[0000318154-24-000011_amgn-20231231.htm:41]** **[0001193125-24-099062_d445034ddef14a.htm:16]** **[0001193125-23-093947_d371686ddef14a.htm:14]** . |
| Murdo Gordon       | Executive Vice President, Global Commercial Operations                   | 2018       | Murdo Gordon became **Executive Vice President, Global Commercial Operations** at Amgen in **2018**. Before joining Amgen, he was the Chief Commercial Officer at Bristol Myers Squibb Company (BMS) from **2016 to 2018** and served as Head of Worldwide Markets at BMS from **2015 to 2016**  **[0000318154-24-000011_amgn-20231231.htm:41]** **[0000318154-23-000017_amgn-20221231.htm:42]** .                                                                 |
| David M. Reese     | Executive Vice President and Chief Technology Officer                    | Dec 2023   | Dr. **David M. Reese** became the Executive Vice President and Chief Technology Officer at Amgen in December 2023. Prior to this role, he served as the Executive Vice President, Research and Development, from 2018 to December 2023. Dr. Reese joined Amgen in 2005 and has held various leadership roles  **[0000318154-24-000011_amgn-20231231.htm:42]** **[0001193125-24-099062_d445034ddef14a.htm:60]** **[0000318154-24-000011_amgn-20231231.htm:41]** .                                                      |
| Peter H. Griffith  | Executive Vice President and Chief Financial Officer                     | 2020       | Peter H. Griffith became the **Executive Vice President and Chief Financial Officer** of Amgen in **2020**. He joined the company in **2019** as Executive Vice President, Finance. Before joining Amgen, Mr. Griffith was President of Sherwood Canyon Group, LLC, and a partner at EY from **1997 to 2019**  **[0000318154-24-000011_amgn-20231231.htm:41]** **[0000318154-23-000017_amgn-20221231.htm:42]** .                                                         |
| Esteban Santos     | Executive Vice President, Operations                                     | 2016       | Esteban Santos became Executive Vice President, Operations, at Amgen in **2016**. He joined the company in **2007** as Executive Director, Manufacturing Technologies. From **2013 to 2016**, he served as Senior Vice President, Manufacturing  **[0000318154-24-000011_amgn-20231231.htm:42]** **[0000318154-23-000017_amgn-20221231.htm:43]** .                                                                                                                        |
| Dr. James E. Bradner| Executive Vice President, Research and Development, and Chief Scientific Officer | Dec 2023   | Dr. James E. Bradner became the Executive Vice President, Research and Development, and Chief Scientific Officer at Amgen in December 2023. Prior to joining Amgen, he was a clinician at the Dana-Farber Cancer Institute from 2022 to 2023 and served as President of the Novartis Institutes for BioMedical Research from 2016 to 2022  **[0000318154-24-000011_amgn-20231231.htm:41]** **[0000318154-24-000011_exhibit1014-agreementbetwe.htm:0]** .                                |
| Jonathan P. Graham | Executive Vice President, General Counsel and Secretary                  | 2019       | Jonathan P. Graham became **Executive Vice President, General Counsel and Secretary** at Amgen in **2019**. He joined the company in **2015** as Senior Vice President, General Counsel and Secretary. Prior to joining Amgen, he was Senior Vice President and General Counsel at Danaher Corporation from **2006 to 2015**  **[0000318154-24-000011_amgn-20231231.htm:41]** **[0000318154-23-000017_amgn-20221231.htm:42]** .                                          |
| Nancy A. Grygiel   | Senior Vice President and Chief Compliance Officer                       | 2020       | Nancy A. Grygiel became **Senior Vice President and Chief Compliance Officer** at Amgen in **2020**. She joined the company in **2015** and served as Vice President, Compliance from **2016 to 2020**. Before joining Amgen, she was Vice President, Compliance, Corporate & International at Allergan, Inc. from **2011 to 2015**  **[0000318154-24-000011_amgn-20231231.htm:41]** **[0000318154-23-000017_amgn-20221231.htm:42]** .                                    |
| Rachna Khosla      | Senior Vice President, Business Development                              | 2021       | Rachna Khosla is the **Senior Vice President, Business Development** at Amgen Inc. She joined the company in **2013** as Corporate Development Director. Over the years, she has held various roles, including Vice President, Business Development from **2018 to 2021**, and Executive Director, Business Development from **2016 to 2018**  **[0000318154-24-000011_amgn-20231231.htm:42]** **[0000318154-23-000017_amgn-20221231.htm:42]** .                          |
| Derek Miller       | Senior Vice President, Human Resources                                   | 2022       | Derek Miller became **Senior Vice President, Human Resources** at Amgen in **2022**. He joined the company in **2003** and has held various human resources leadership roles. Prior to his current role, he was Vice President, Global Total Rewards from **2020 to 2022**, and Vice President, Human Resources from **2018 to 2020**  **[0000318154-24-000011_amgn-20231231.htm:42]** **[0000318154-23-000017_amgn-20221231.htm:43]** .                                 |

35e81e6b5a019ba86bea613dc0c52613edb4fcc58dfcfa296b8a93ce686b0db1

| Program Details          | Program 1       |
|--------------------------|-----------------|
| Approval Date            | N/A             |
| End Date/Duration        | N/A             |
| Total Additional Amount  | N/A             |
| Remaining Authorization  | **$7.0 billion**  **[0000318154-24-000044_amgn-20240930.htm:45]** **[0000318154-24-000044_amgn-20240930.htm:17]** **[0000318154-24-000044_amgn-20240930.htm:66]**  |
| Details                  | No repurchase activity during the nine months ended September 30, 2024  **[0000318154-24-000044_amgn-20240930.htm:45]** **[0000318154-24-000044_amgn-20240930.htm:17]** **[0000318154-24-000044_amgn-20240930.htm:66]**  |

5309792c9a313a0a6366145f66d17b98cc4366fda54efb8d6fb43af76b41d8a4

U.S. Product Sales

ROW Product Sales

Total Product Sales

U.S. Other Revenues

ROW Other Revenues

Total Other Revenues

Total U.S. Revenues

Total ROW Revenues

Total Revenues

01af047355b0c3dbc0c61ad2a034796169f62b077546218513f651310e55cf56

**Quarterly guidance for Q4 2024:**
- **Non-GAAP EPS**: Expected to be lower than Q3 Non-GAAP EPS  **[AMGN_3404741_8]**  (no prior guidance)

**Annual guidance for FY 2024:**
- **Total Revenues**: $33.0B – $33.8B  **[AMGN_3404741_8]**  (raised from $32.8B – $33.8B  **[AMGN_3396666_11]** )  
- **Non-GAAP EPS**: $19.20 – $20.00  **[AMGN_3404741_8]**  (no change from $19.10 – $20.10  **[AMGN_3396666_11]** )  
- **OI&E**: $2.4B – $2.5B  **[AMGN_3404741_9]**  (lowered from approximately $2.5B  **[AMGN_3396666_12]** )  
- **Non-GAAP Tax Rate**: 14% – 15%  **[AMGN_3404741_9]**  (lowered from 15% – 16%  **[AMGN_3396666_12]** )  
- **Capital Expenditures**: $1.3B  **[AMGN_3404741_9]**  (no change from $1.3B  **[AMGN_3396666_12]** )  
- **Non-GAAP R&D Growth**: More than 25% year-over-year  **[AMGN_3404741_9]**  (no change from more than 25% year-over-year  **[AMGN_3396666_12]** )  
- **Non-GAAP Operating Expenses**: ~25% year-over-year  **[AMGN_3404741_9]**  (no prior guidance)  
- **New Asset Sales**: $400M  **[AMGN_3404741_8]**  (no prior guidance)  
- **Other Revenue**: $1.4B  **[AMGN_3404741_8]**  (no prior guidance)  

7e15af5f11d394efa7cf3b2830f37353de43e177a273451f3613f84183d85cbf

| Name               | Start Date | End Date | Reason for Change |
|--------------------|------------|----------|-------------------|
| Ernst & Young LLP | 1980  **[0000318154-24-000011_amgn-20231231.htm:167]**    | Present  | Current auditor   |

e16d9e25e59e1bc43b5c564a7ed2956a3f68084b051891e961952dc57b6e5963

01a925a2b682272b471d70264ec532b026020fd759b5fbecdcc6dee0b31351df

46a995e296388145d0cd6b002a2d0a0a2faddded6df087f91fe0a0c8b7c5df2b

- Total Revenue: **$8.503 billion** (+23% YoY)  **[0000318154-23-000064_amgn-20230930.htm:2]** **[0000318154-24-000044_amgn-20240930.htm:2]**   
- U.S. Product Sales: $5.979 billion (+28% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:34]**   
- ROW Product Sales: $2.172 billion (+17% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:34]**   
- Prolia: $1.045 billion (+6% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- ENBREL: $825 million (**-20% YoY**)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- Repatha: $567 million (**+40% YoY**)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- EVENITY: $399 million (+30% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- KYPROLIS: $378 million (+8% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- Nplate: $456 million (+9% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- Other Products: $1.363 billion (-17% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- Total Product Sales: $8.151 billion (+24% YoY)  **[0000318154-23-000064_amgn-20230930.htm:9]** **[0000318154-24-000044_amgn-20240930.htm:9]**   
- Net Income: $2.83 billion (**+63% YoY**)  **[0000318154-23-000064_amgn-20230930.htm:2]** **[0000318154-24-000044_amgn-20240930.htm:2]**   
- EPS (Diluted): $5.23 (+63% YoY)  **[0000318154-23-000064_amgn-20230930.htm:2]** **[0000318154-24-000044_amgn-20240930.htm:2]**   

c521ca901c345dcba8d235d3ca457b32d15e5ace991e011ee0951e9f030b5777

4cc4c10a5319123bf5fc3ce97fb0299c8420a57e9677abd574a5ca5dc0823819

Volume growth for Repatha (percentage)

Volume growth for Otezla (percentage)

Volume growth for Prolia (percentage)

91a0df123b4a101d21f6e0e9715619495e377084e597eee07e47828a794525da

- Amgen's **AMG 786**, an oral medicine for obesity, is progressing well with **Phase I readout on track for the first half of 2024**, indicating potential advancement in a high-demand therapeutic area.  **[AMGN_3372061_30]**
- **AMG 133** has shown promising **Phase I results**, being well-tolerated and delivering **durable weight loss** without significant effects on blood pressure and lipids, with **Phase II data expected by the end of the year**.  **[AMGN_3372061_25]**
- Strong preclinical support for **daxtilimab**, targeting **ILT7** for autoimmune diseases, demonstrates Amgen's commitment to innovative therapies in immunology, with ongoing efforts to generate clinical data.  **[AMGN_3372061_28]**

5b78f1641d95df5ddc85c76f0fd01cc9fe344e9bb93d426989391a549a28ae14

- **Strong growth potential from innovative pipeline assets**, such as Maridebart cafraglutide (AMG 133) for obesity, which may offer less frequent dosing and significant market share, driving a **good return on investment**.  **[AMGN_3362954_27]**
- **Successful integration of Horizon Therapeutics**, adding a significant rare disease business to Amgen's portfolio, expected to be **additive to the growth** from their base business.  **[AMGN_3362954_1]** **[AMGN_3362954_0]** **[AMGN_3362954_3]**
- **Raised 2023 revenue guidance to $28.0 billion to $28.4 billion**, reflecting **strong performance of the base business** with **record sales** in seven products and **11% volume growth**, indicating **good momentum across the board**.  **[AMGN_3362954_10]** **[AMGN_3362954_14]**

8899d66a7810f49a15d17b83b2ae5db914f4c88e63adcf6fdb13abc5de4d28aa

- **Executives were unable to provide specific timelines or details on the initiation of Phase III studies for MariTide**, their obesity candidate, indicating potential uncertainties in the development timeline.  **[AMGN_3382225_29]**
- **Lack of updates on AMG 651**, their EGFR-CD3 bispecific program, with executives stating they have **no news to share**, possibly signaling slow progress or challenges in the development.  **[AMGN_3382225_26]**
- When questioned about safety metrics for MariTide, **executives avoided providing detailed information**, which may raise concerns about safety issues in the ongoing study.  **[AMGN_3382225_14]** **[AMGN_3382225_15]**

b1dd37fadae363b8302d651d8a26923c6b634d593c015a5857c1dfff93aec44e

1. **MariTide Differentiation**  
   **Q:** What differentiates MariTide from competitors?  
   **A:** Management highlighted MariTide's **broad and differentiated profile**  **[AMGN_3382225_13]** , with potential advantages in **efficacy, tolerability, and dosing interval**.  **[AMGN_3382225_16]**  They are confident in its ability to **address unmet medical needs** and provide access for **millions of patients**  **[AMGN_3382225_21]** , positioning it as a **competitive** product in the market.  **[AMGN_3382225_16]** 

2. **Manufacturing Capacity for MariTide**  
   **Q:** Can you meet manufacturing demands for MariTide?  
   **A:** The company is confident in supplying **millions of patients** with MariTide  **[AMGN_3382225_19]** , leveraging their experience in biotherapeutic manufacturing.  **[AMGN_3382225_18]**  They emphasized their commitment to **supplying every patient, every time**  **[AMGN_3382225_18]** , noting that **monthly or less frequent dosing** reduces the need for injection devices compared to weekly therapies.  **[AMGN_3382225_19]** 

3. **Tarlatamab Launch Preparation**  
   **Q:** How are you preparing for Tarlatamab's launch?  
   **A:** Amgen is **well-prepared** for Tarlatamab's potential approval  **[AMGN_3382225_17]** , with trained field personnel and plans for **broad access** upon approval.  **[AMGN_3382225_17]**  They view it as a **major advance** in small cell lung cancer treatment and have initiated **three Phase III studies** to move it into earlier therapy lines.  **[AMGN_3382225_17]** 

4. **MariTide Expansion Plans**  
   **Q:** Will MariTide target conditions beyond obesity and diabetes?  
   **A:** Management is planning a **broad Phase III program** to address unmet needs in obesity and related conditions  **[AMGN_3382225_23]** , continuing to develop MariTide as intended.  **[AMGN_3382225_23]** 

5. **TEZSPIRE in COPD**  
   **Q:** What's TEZSPIRE's potential role in COPD?  
   **A:** TEZSPIRE showed **clinically meaningful activity** in a Phase II COPD trial  **[AMGN_3382225_25]** , with full data to be presented at the American Thoracic Society Meeting.  **[AMGN_3382225_25]**  The company recognizes COPD's **heterogeneity** and is interested in further development due to the drug's mechanism targeting type 2 inflammation.  **[AMGN_3382225_25]** 

6. **Rocatinlimab Differentiation**  
   **Q:** How will Rocatinlimab compete in atopic dermatitis?  
   **A:** Rocatinlimab aims for a **competitive profile** with strong efficacy and excellent patient experience.  **[AMGN_3382225_24]**  The Phase III HORIZON study involves **726 patients**  **[AMGN_3382225_24]** , and management believes it can be effectively positioned against treatments like Dupixent.  **[AMGN_3382225_24]** 

7. **MariTide Phase III Timing**  
   **Q:** When will MariTide's Phase III start, and how will you accelerate it?  
   **A:** The company plans to **complete Phase II** and work swiftly with regulators on the Phase III program  **[AMGN_3382225_29]** , moving as rapidly as possible to address the **huge unmet need**.  **[AMGN_3382225_29]** 

8. **BLINCYTO in Autoimmune Disorders**  
   **Q:** Any plans for BLINCYTO in autoimmune diseases?  
   **A:** Management is **well-organized** to explore BLINCYTO's potential in **autoimmune disorders**  **[AMGN_3382225_27]** , finding recent findings **inspiring** and planning to report more in the future.  **[AMGN_3382225_27]** 

9. **AMG 651 Oncology Development**  
   **Q:** Any updates on AMG 651's development in oncology?  
   **A:** The company continues to study AMG 651 and other **solid tumor targeting bispecific T-cell engagers**  **[AMGN_3382225_26]** , with no new data yet but confidence inspired by tarlatamab's progress.  **[AMGN_3382225_26]** 

b0f79896f0287e5a7011e2d09d3298162c5b20cc35eec4c6167cc5a0ba3f80fc

- **Potential delays in AMG 133's development program**: Amgen indicated that the initiation of Phase III trials for their obesity drug, AMG 133 (Maridebart cafraglutide), may be delayed as they require a certain safety database before proceeding. They will provide guidance on timing as they get into next year, suggesting potential delays beyond 2024.  **[AMGN_3362954_26]**
- **Increased interest expenses due to Horizon acquisition debt**: Amgen has taken on significant debt of **$28 billion** with a weighted average interest rate of **5.6%** to finance the Horizon Therapeutics acquisition. This results in higher interest expenses, with expected **OI&E to be about $700 million** in Q4, impacting earnings in Q4 2023 and potentially in 2024.  **[AMGN_3362954_13]**
- **Discontinuation of AMG 340 impacting oncology pipeline**: The company is discontinuing the development of their PSMA-targeting bispecific **AMG 340**, which could negatively impact their oncology pipeline and future growth prospects in the metastatic castrate-resistant prostate cancer market.  **[AMGN_3362954_9]**

3c24a843945de096449ab392e00a1d4f088c9cff12366588b6752f007cbbfb94

1. **AMG 133 (Obesity Drug Development)**  
   **Q:** Can you discuss the recent Phase I data for AMG 133 and its competitive profile?  
   **A:** We are pleased with the Phase I results of AMG 133, where the highest dose of **420 mg** led to **14.5% weight loss by day 85**, with effects durable up to day 150 and mild gastrointestinal side effects.  **[AMGN_3372061_15]**  The Phase II study is exploring **11 dosing cohorts** to find the optimal dose and schedule, including less frequent dosing than monthly.  **[AMGN_3372061_16]**  We believe the data supports our ongoing efforts to develop this therapy to benefit patients with obesity.  **[AMGN_3372061_15]** 

2. **AMG 133 Phase III Plans**  
   **Q:** What informs your next indications for AMG 133 and timing of the Phase III program?  
   **A:** Obesity is a major public health crisis, and we plan to develop AMG 133 in all indications where its dual mechanism can improve public health.  **[AMGN_3372061_24]**  We are actively planning an expansive Phase III program, expecting to move multiple indications forward in parallel as soon as we have the requisite data.  **[AMGN_3372061_24]** 

3. **AMG 133 Dosing and Patient Experience**  
   **Q:** Can you provide insight into AMG 133 dosing and its clinical profile compared to competitors?  
   **A:** The doses we are using are well within scope for a modern biotherapeutic, and we have the capabilities to deliver this medicine at any required dose and schedule.  **[AMGN_3372061_21]**  Our antibody inhibits the GIP receptor, a choice supported by strong genetic insights showing reduced BMI with GIP inhibition.  **[AMGN_3372061_21]**  We anticipate a positive and simple patient experience, drawing from our experience with other biologics.  **[AMGN_3372061_21]** 

4. **TEPEZZA Growth Strategy**  
   **Q:** What are your priorities for TEPEZZA to continue growing the patient base?  
   **A:** We are seeing growth with a record number of unique TEPEZZA patients and increased patient starts.  **[AMGN_3372061_18]**  We have expanded payer coverage to over **50% of U.S. covered lives**.  **[AMGN_3372061_18]**  With low penetration among the approximately **100,000 eligible patients** in the U.S., we are focusing on continued execution to drive uptake.  **[AMGN_3372061_18]**  We are also excited about the international opportunity and investments in innovation for thyroid eye disease patients.  **[AMGN_3372061_18]** 

5. **TEZSPIRE in COPD Differentiation**  
   **Q:** How will you differentiate TEZSPIRE in COPD given competitive data from Dupixent?  
   **A:** Our Phase II COPD study includes **337 patients** with moderate to severe COPD who continue to have exacerbations despite triple therapy, reflecting the unmet need.  **[AMGN_3372061_19]**  TEZSPIRE targets TSLP upstream, potentially impacting disease biology more effectively and treating a broader patient population.  **[AMGN_3372061_19]**  We believe we can help patients refractory to existing therapies.  **[AMGN_3372061_19]** 

6. **UPLIZNA Expansion Opportunities**  
   **Q:** Where do you see UPLIZNA fitting into the MG treatment paradigm and expansion opportunities?  
   **A:** UPLIZNA is growing nicely in neuromyelitis optica spectrum disorder (NMOSD), becoming the **fastest-growing biologic** in that indication.  **[AMGN_3372061_22]**  CD19 is a valuable target, and we see opportunities to expand into additional autoimmune diseases by targeting all B cells except plasma cells.  **[AMGN_3372061_22]** 

7. **Xaluritamig Positioning in Prostate Cancer**  
   **Q:** What are your data disclosure plans for Xaluritamig, and how is it positioned against competitors?  
   **A:** Xaluritamig is a STEAP1 CD3 bispecific being studied in advanced castrate-resistant prostate cancer.  **[AMGN_3372061_26]**  Our priorities include establishing reduced monitoring and exploring combinations with novel agents.  **[AMGN_3372061_26]**  We plan to present the regulatory path in due course and are encouraged by the clinically meaningful response rates in patients with advanced disease.  **[AMGN_3372061_26]** 

8. **GIP Antagonism vs. Agonism Debate**  
   **Q:** Do you have any response to competitors favoring GIP agonism over antagonism?  
   **A:** The argument for GIP receptor antagonism comes from robust scientific data, including genetic studies showing reduced BMI with GIP inhibition.  **[AMGN_3372061_27]**  We feel confident in our approach and the potential benefits of AMG 133.  **[AMGN_3372061_27]** 

9. **Subcutaneous TEPEZZA Delivery**  
   **Q:** Can you provide details on the technology for subcutaneous TEPEZZA delivery?  
   **A:** We are moving forward with developing a subcutaneous formulation of TEPEZZA but are not commenting on the specific technology provider at this time.  **[AMGN_3372061_23]** 

10. **Daxtilimab Development in Lupus**  
    **Q:** What is your level of confidence in daxtilimab for lupus, and when will we see data?  
    **A:** It's early days for daxtilimab, but we have strong preclinical support and believe in its potential based on the underlying biology.  **[AMGN_3372061_28]**  The target helps control central signaling in autoimmune diseases, and we are focused on generating clinical data.  **[AMGN_3372061_28]** 

11. **AMG 786 Progress**  
    **Q:** What's driving the delay in AMG 786 progress, and when should we expect data?  
    **A:** AMG 786 is an oral medicine being developed for obesity, and the study is progressing well.  **[AMGN_3372061_30]**  We expect to have the Phase I readout in the first half of **2024**.  **[AMGN_3372061_30]** 

12. **AMG 133 Impact on Blood Pressure and Lipids**  
    **Q:** Do you expect AMG 133 to impact blood pressure and lipids similar to tirzepatide?  
    **A:** It's too early to draw conclusions, but we are making these measurements and will have data at the end of Phase II.  **[AMGN_3372061_25]**  We are focused on understanding the full clinical profile of AMG 133.  **[AMGN_3372061_25]** 

13. **AMG 133 Discontinuations and Liver Enzyme Elevations**  
    **Q:** Can you comment on discontinuations at high doses and liver enzyme elevations in AMG 133 trials?  
    **A:** Four out of eight patients at the **420 mg** dose declined further participation mainly for logistical reasons, with adverse events comparable to other patients.  **[AMGN_3372061_20]**  Regarding liver enzyme elevations, it's too early to provide patient-level insights.  **[AMGN_3372061_20]** 

14. **AMG 133 Lipid Effects**  
    **Q:** Is it too early to attribute triglyceride changes to GIP antagonism in AMG 133?  
    **A:** Yes, it's too early to attribute lipid changes to antagonism versus agonism.  **[AMGN_3372061_29]**  Lipids are variable and indirect biomarkers; we are making measurements in Phase II.  **[AMGN_3372061_29]** 

15. **TEZSPIRE Commercial Strategy**  
    **Q:** How are you planning to commercialize TEZSPIRE effectively in the COPD market?  
    **A:** With our unique and differentiated mechanism, we aim to treat a broader patient population, including those refractory to current therapies.  **[AMGN_3372061_19]**  We have strong commercial capabilities with our partner AstraZeneca and are well-positioned to bring TEZSPIRE to market.  **[AMGN_3372061_19]** 

a11fc146d8f8a779db3f74a9047de6f24c8ddfaa6e88734013ebe910204d4b36

7c630dc1e764f0c0d08db6264605571d31fa09ac50f0f5188459f7d8550bcf8f

| Year | Amount Due (in billions) | Debt Type                  | Interest Rate (%) | % of Total Debt                                                                 |
|----------|------------------------------|---------------------------------|-----------------------|------------------------------------------------------------------------------------|
| 2025     | 3.544                        | 1.90%, 5.25%, 3.125% Notes     | 1.90, 5.25, 3.125     | 5.9% = (3.544 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2026     | 4.220                        | 2.00% (€750M), 5.507%, 2.60%, 5.50% (£475M) Notes | 2.00, 5.507, 2.60, 5.50 | 7.0% = (4.220 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2027     | 2.724                        | 2.20%, 3.20% Notes             | 2.20, 3.20            | 4.5% = (2.724 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2028     | 4.984                        | 5.15%, 1.65% Notes             | 5.15, 1.65            | 8.3% = (4.984 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2029     | 2.936                        | 3.00%, 4.05%, 4.00% (£700M) Notes | 3.00, 4.05, 4.00      | 4.9% = (2.936 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2030     | 4.000                        | 2.45%, 5.25% Notes             | 2.45, 5.25            | 6.6% = (4.000 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2031     | 1.250                        | 2.30% Notes                    | 2.30                  | 2.1% = (1.250 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2032     | 2.001                        | 2.00%, 3.35% Notes             | 2.00, 3.35            | 3.3% = (2.001 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2033     | 5.000                        | 4.20%, 5.25% Notes             | 4.20, 5.25            | 8.3% = (5.000 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2037     | 0.478                        | 6.375% Notes                   | 6.375                 | 0.8% = (0.478 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2038     | 0.254                        | 6.90% Notes                    | 6.90                  | 0.4% = (0.254 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2039     | 0.333                        | 6.40% Notes                    | 6.40                  | 0.6% = (0.333 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2040     | 2.041                        | 3.15%, 5.75% Notes             | 3.15, 5.75            | 3.4% = (2.041 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2041     | 2.105                        | 2.80%, 4.95%, 5.15% Notes      | 2.80, 4.95, 5.15      | 3.5% = (2.105 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2042     | 0.415                        | 5.65% Notes                    | 5.65                  | 0.7% = (0.415 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2043     | 2.935                        | 5.60%, 5.375% Notes            | 5.60, 5.375           | 4.9% = (2.935 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2045     | 2.250                        | 4.40% Notes                    | 4.40                  | 3.7% = (2.250 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2048     | 1.415                        | 4.563% Notes                   | 4.563                 | 2.3% = (1.415 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2050     | 1.764                        | 3.375% Notes                   | 3.375                 | 2.9% = (1.764 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2051     | 3.541                        | 4.663% Notes                   | 4.663                 | 5.9% = (3.541 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2052     | 1.785                        | 3.00%, 4.20% Notes             | 3.00, 4.20            | 3.0% = (1.785 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2053     | 6.190                        | 4.875%, 5.65%, 2.77% Notes     | 4.875, 5.65, 2.77     | 10.2% = (6.190 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                   |
| 2062     | 1.165                        | 4.40% Notes                    | 4.40                  | 1.9% = (1.165 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2063     | 2.750                        | 5.75% Notes                    | 5.75                  | 4.6% = (2.750 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |
| 2097     | 0.100                        | 8.125% Debentures              | 8.125                 | 0.2% = (0.100 / 60.398) * 100 **[0000318154-24-000044_amgn-20240930.htm:16]** **[0000318154-24-000044_amgn-20240930.htm:16]**                                    |

5287e7afb45a63fa901d9ca6b4a71d7a70ebba940536e3eec385dd85e7edecd8

1. **MariTide's Position in Obesity Market**  
   **Q:** How will MariTide compete amid obesity drug competition?  
   **A:** Amgen is confident in **MariTide's differentiated profile** and its ability to address unmet medical needs in obesity and Type-2 diabetes. Despite intense competition and the rise of oral medications, MariTide's **monthly or less frequent dosing** offers a unique advantage, potentially improving patient adherence and persistence on weight loss medication.  **[AMGN_3396666_16]** 

2. **MariTide's Phase III Timing**  
   **Q:** When will MariTide's Phase III enrollment begin?  
   **A:** While focused on completing the Phase II trial, Amgen is moving swiftly into Phase III. Detailed timelines aren't disclosed due to competitive reasons, but the company anticipates providing more information over the coming year.  **[AMGN_3396666_21]** 

3. **Enbrel's CMS Price Negotiation Impact**  
   **Q:** How will CMS pricing affect Enbrel revenues?  
   **A:** The CMS price reduction will have a mitigated impact since **approximately 25% of Enbrel revenues** come from Medicare Part D. Amgen continues to monitor how Part D redesign will influence formularies and patient costs, noting that out-of-pocket expenses for some patients may rise despite caps.  **[AMGN_3396666_15]** 

4. **CapEx Increase and MariTide Manufacturing**  
   **Q:** What's driving the CapEx increase in 2024?  
   **A:** Amgen expects **2024 CapEx of $1.3 billion**, up from previous guidance of $1.1 to $1.2 billion, primarily due to expanding MariTide manufacturing capacity. This investment supports the anticipated demand and scalability of the obesity drug.  **[AMGN_3396666_17]** 

5. **Tax Dispute with IRS**  
   **Q:** What's the status of the tax court case?  
   **A:** The court date is set for **November 4**, and Amgen remains confident in its position and reserves. The company notes that recent tax court decisions have reinforced the value of manufacturing in Puerto Rico, and there has been no change in their evaluation of the case.  **[AMGN_3396666_22]** 

6. **Operating Margins Outlook**  
   **Q:** How will investments affect 2025 margins?  
   **A:** While not providing long-term margin guidance, Amgen emphasizes its commitment to investing in innovation with a disciplined approach to capital allocation. Despite increased R&D spend, the company is focused on productivity and prioritization to preserve margins.  **[AMGN_3396666_23]** 

7. **TEPEZZA Growth Prospects**  
   **Q:** When will TEPEZZA see acceleration in low CAS patients?  
   **A:** Amgen is making progress in expanding access for TEPEZZA, achieving **favorable medical policy changes for over 65% of U.S. covered lives**, up from 50% last quarter. The focus on endocrinologists and ophthalmologists aims to better serve the **80,000 low CAS patients** in the U.S. The Japanese market is expected to contribute positively next year.  **[AMGN_3396666_27]** 

8. **IMDELLTRA Launch and Lessons from BLINCYTO**  
   **Q:** What feedback is there on the IMDELLTRA launch?  
   **A:** Early feedback on IMDELLTRA is very positive, with clinicians quickly adopting it due to its transformative impact in a difficult disease setting. Amgen is leveraging lessons from BLINCYTO to expedite IMDELLTRA's development into frontline therapies and reduce monitoring requirements.  **[AMGN_3396666_18]** 

9. **MariTide in Diabetes**  
   **Q:** How will MariTide compete in diabetes market?  
   **A:** Amgen plans to initiate a dedicated Phase II study for MariTide in diabetes patients. This study isn't required for the obesity Phase III but aims to optimize dosing for diabetic patients. The **monthly or less frequent dosing** offers differentiation in a market with many products controlling HbA1c but lacking in adherence and persistence.  **[AMGN_3396666_24]** 

10. **Next Obesity Asset Entering Clinic**  
    **Q:** What is the next obesity program entering clinics?  
    **A:** Amgen is advancing a new obesity program into clinical development later this year. While details are limited due to competitive reasons, the company is exploring both incretin pathways and novel targets, including oral medications, aiming for true differentiation and addressing unmet market segments.  **[AMGN_3396666_20]** 

1d85f2483d1d13b8182b9bda41e0f7b4e5efa11e8a106890988492e7cfaae6a3

- **Amgen is rapidly advancing MariTide, a promising obesity treatment, and plans to move swiftly to Phase III studies due to positive Phase II results and recognizing a huge unmet need in the marketplace.**  **[AMGN_3382225_29]** ,  **[AMGN_3382225_15]**
- **Amgen's deep expertise in CD19-directed therapeutics, inflammation, and autoimmunity positions it to capitalize on new opportunities, inspired by recent developments in systemic sclerosis and refractory rheumatoid arthritis treatments.**  **[AMGN_3382225_28]**
- **Amgen is leveraging its experience in developing CD3 bispecifics to advance solid tumor targeting T-cell engaging therapies, expecting future progress on medicines like AMG 651 and tarlatimab.**  **[AMGN_3382225_26]**

fe59a78ae3395c270c05e6ca30c3d5fae65ba9fccc0a6fe46d529740ff596562

1. **Mirati Phase II Data and Phase III Plans**  
   **Q:** What can you share about Mirati Phase II data and Phase III plans?  
   **A:** Amgen is excited about Mirati's prospects. They've begun a Phase II study in type 2 diabetes, which is progressing well, and expect to have data by the end of the year. They look forward to sharing these results with investors when available.  **[AMGN_3404741_10]**  They're actively planning a broad Phase III program, including obesity and type 2 diabetes, anticipating a large global trial to fully explore the molecule.  **[AMGN_3404741_11]** 

2. **Investment in Mirati and R&D Spending**  
   **Q:** How will the Phase III Mirati program affect your spending?  
   **A:** Amgen's investment in the Phase III trial will reflect their view of Mirati as a differentiated molecule. They raised their CapEx guidance to about **$1.3 billion**, being thoughtful about this increase.  **[AMGN_3404741_11]**  Research and development spending is up **35%** quarter-over-quarter and expected to rise over **25%** for the year, emphasizing their commitment to innovation with Mirati at the forefront.  **[AMGN_3404741_11]** 

3. **TEPEZZA Growth and Sales Force Expansion**  
   **Q:** What's the growth plan for TEPEZZA and impact of sales team?  
   **A:** TEPEZZA grew **8%** year-over-year.  **[AMGN_3404741_13]**  Amgen is focusing on both high CAS patients and approximately **80,000** low CAS patients. They've expanded their sales force to reach comprehensive ophthalmologists, ocular specialists, and endocrinologists, aiming to optimize coverage and enable better access to TEPEZZA.  **[AMGN_3404741_13]**  This change occurred in the third quarter, and they expect momentum to build over the next several quarters.  **[AMGN_3404741_13]** 

4. **Competitive Position in Obesity Treatment Portfolio**  
   **Q:** Do you have a competitive obesity treatment portfolio?  
   **A:** Amgen is pleased with MariTide's progress and is fully focused on setting up a broad Phase III program.  **[AMGN_3404741_12]**  They're actively investigating additional obesity medicines, both preclinically and clinically, including program 513. While they haven't disclosed 513's mechanism of action, they're exploring both injectable and oral medicines, targeting incretin and non-incretin pathways to serve all patients with obesity and related conditions.  **[AMGN_3404741_12]** 

5. **TEZSPIRE in COPD Competitive Landscape**  
   **Q:** How does TEZSPIRE fit into the COPD treatment landscape?  
   **A:** Amgen, with AstraZeneca, reported positive Phase II results for TEZSPIRE in moderate to very severe COPD, showing a **17%** numerical reduction in exacerbation rates over 52 weeks.  **[AMGN_3404741_18]**  They've learned which patient subsets benefit most and plan to initiate Phase III studies. TEZSPIRE's unique mechanism addresses a broader patient population, and they feel confident about competing in the COPD market.  **[AMGN_3404741_18]** 

6. **Biosimilar Launch Strategy and Supply Advantages**  
   **Q:** How are you approaching the launch of biosimilars like Path Blue amid supply issues?  
   **A:** Amgen is excited about launching Path Blue and other biosimilars.  **[AMGN_3404741_17]**  Being among the first is crucial, and they expect strong interest early in the launch phase. While permanent Q codes are important, there's significant interest even with temporary reimbursement codes.  **[AMGN_3404741_17]**  They've benefited from shortages of other biosimilars, including Avastin, due to their reliable supply chain and world-class manufacturing.  **[AMGN_3404741_24]** 

7. **Subcutaneous BLINCYTO Development**  
   **Q:** What's the status of subcutaneous BLINCYTO's development?  
   **A:** Developing subcutaneous BLINCYTO is a major priority. Previous studies showed encouraging efficacy, with a **67%** complete remission rate within one cycle among 21 patients.  **[AMGN_3404741_15]**  Further data revealed an **85%** complete remission rate, with **75%** achieving MRD negativity, all without grade 4 CRS. The registrational study is progressing, and there's nothing significant about the timing change.  **[AMGN_3404741_15]** 

8. **Impact of GLP-1 Receptor Agonist Development**  
   **Q:** Will you adjust titration schedules for MariTide's Phase III?  
   **A:** Amgen is on track with Phase III planning for MariTide but isn't sharing specifics on dosing approaches now. They are confident their strategy will be informed by the ongoing Phase II study, with data expected later this year.  **[AMGN_3404741_16]** 

9. **Insights into Anti-Diabetic Activity from Phase II**  
   **Q:** Can you assess A1C effects in your Phase II obesity trial?  
   **A:** Amgen hopes to gain insights into anti-diabetic activity from the Phase II study, as type 2 diabetes often accompanies obesity.  **[AMGN_3404741_20]**  However, they acknowledge the need for a dedicated Phase II study in patients without obesity to draw definitive conclusions, expecting to share more later this year.  **[AMGN_3404741_20]** 

10. **Enbrel Performance and Expectations**  
    **Q:** Is Enbrel's Q3 performance indicative of future trends?  
    **A:** Enbrel faced two negative trends: the regular decline in net price and a **30%** adjustment this quarter, making results softer than usual.  **[AMGN_3404741_21]**  Despite this, volume grew by **4%**, showing continued prescriber support. Amgen anticipates continued net price declines moving forward.  **[AMGN_3404741_21]** 

021ef6b156d26566d2f314e7549668bc544d3302ac88470ac482c764e5eef8bb

- **Potential delays in clinical trials for AMG 786**, as analysts noted it seems to be taking a long time to enroll patients, raising concerns about the drug's development timeline. The executive stated that the study is "progressing fine" and expects a Phase I readout in the first half of 2024, but this may indicate setbacks.  **[AMGN_3372061_30]**
- **High competition and uncertainty for daxtilimab targeting ILT7**, with executives acknowledging it's in the "earliest phases of clinical investigation" within a "very competitive landscape," suggesting challenges in standing out among competitors.  **[AMGN_3372061_28]**
- **Lack of clarity on AMG 133's efficacy in Phase II trials**, as executives were unable to provide specifics on expected impacts on blood pressure and lipids, stating it's "too early to try to answer" these questions, potentially raising doubts about the drug's ability to match competitors like tirzepatide.  **[AMGN_3372061_25]**

bf70a17e86dc98d5edc72b0b229db957b972550235bb2a464fe9a3ba4d6b8454

- **Amgen is facing reimbursement challenges and delays in patient access for TEPEZZA, particularly among low Clinical Activity Score (CAS) patients, which may hinder its growth prospects in the U.S.**  **[AMGN_3396666_27]**
- **The company is involved in ongoing tax litigation with the IRS, and recent unfavorable decisions against similar companies like Coca-Cola may have negative implications for Amgen's case, potentially impacting financial reserves and future earnings.**  **[AMGN_3396666_22]**
- **Amgen may be lagging behind competitors in the obesity treatment market, with concerns about its positioning as other companies advance multiple products into late-stage development, potentially affecting its future growth in this area.**  **[AMGN_3396666_16]**

f8280aab1c232a32f5c82be2c0349275f37627973897f83f603ed4b19f2e1ead

- **Strong Financial Performance:** Amgen achieved a **20% year-over-year sales growth** to **$8.4 billion** in the second quarter of 2024, with **12 products growing at least double digits**, including **Repatha, TEZSPIRE, EVENITY, TAVNEOS, and BLINCYTO**, demonstrating robust execution across the portfolio.  **[AMGN_3396666_1]** **[AMGN_3396666_6]**
- **Promising Pipeline with Recent Approvals:** The company has a **strong and promising R&D pipeline**, achieving **accelerated approvals** for **IMDELLTRA**, a **landmark new medicine for small cell lung cancer**, and **BLINCYTO** in frontline B-cell precursor acute lymphoblastic leukemia, with physicians expressing excitement about these innovations. **TEZSPIRE** received **Breakthrough Therapy designation** for COPD, highlighting potential for future growth through new indications and therapies.  **[AMGN_3396666_1]** **[AMGN_3396666_7]**
- **Growth Opportunities in Rare Diseases with TEPEZZA:** Amgen sees significant growth opportunities for **TEPEZZA** in the U.S., having achieved **favorable medical policy changes for over 65% of U.S. covered lives**, up from **just over 5% a year ago**, and is preparing for the **launch in Japan next year**, expecting it to be **an attractive market**. The company is **on track with synergy targets** and aims to gain more leverage by taking full control of the supply chain for rare disease products.  **[AMGN_3396666_27]**

26ed9e51a8d580087ad4bca9f9fe3fc533ebbb3d0608e85d58d3e1602902e7a8

Amgen Inc (AMGN)

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