ca907b11b1a48a6fcf34e901eadfa62d7c1c84a25b608869352e64e46633a8a1

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for serious diseases, including eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases **[0001804220-24-000009_regn-20231231.htm:170]** **[0001804220-24-000017_regn-20240331.htm:27]** **[0001804220-24-000040_regn-20240930.htm:29]** **[0001804220-24-000009_regn-20231231.htm:5]**. The company operates in one business segment, encompassing all activities related to the discovery, development, and commercialization of these medicines **[0001804220-24-000009_regn-20231231.htm:170]** **[0001804220-24-000009_regn-20231231.htm:51]**. Regeneron's key products include EYLEA and Dupixent, which are critical to the company's revenue generation **[0001804220-24-000009_regn-20231231.htm:122]**. The company also engages in collaborations with other pharmaceutical companies, such as Sanofi and Bayer, to develop and commercialize certain products **[0001804220-24-000009_regn-20231231.htm:122]**.

1. **EYLEA** - Treats various eye conditions and is a significant contributor to Regeneron's financial performance.
2. **Dupixent** - Used for allergic and inflammatory diseases, playing a crucial role in the company's revenue generation.
3. **Collaborative Products** - Developed and commercialized through partnerships with companies like Sanofi and Bayer, supporting Regeneron's revenue streams.

3d0de330c8010f460bd0062150e48a3b567adac56d0e22f1212d2451319815f0

Average headcount (headcount)

a26b4cc65231e9bd70c68dc551e9847648e75723296e3c154495bf16d5cd41e4

| Metric [Unit: $ Million] | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|--------------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| **EYLEA (U.S.)**         | 1,496  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 1,430  **[0001804220-23-000015_exhibit991q12023.htm:0]**  | 1,500  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 1,448  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 1,460  **[0001804220-24-000006_exhibit991q42023.htm:0]**  | 1,401.6  **[0001804220-24-000015_exhibit991q12024.htm:2]**  | 1,535  **[0001804220-24-000026_exhibit991q22024.htm:0]**  | 1,536.9  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **EYLEA HD (U.S.)**      | N/A     | N/A     | N/A     | 43  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 123  **[0001804220-24-000006_exhibit991q42023.htm:0]**  | N/A     | 304  **[0001804220-24-000026_exhibit991q22024.htm:0]**  | N/A     |
| **Libtayo (Global)**     | 152  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 177  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 210  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 232  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 244  **[0001804220-24-000006_exhibit991q42023.htm:0]**  | 263.9  **[0001804220-24-000015_exhibit991q12024.htm:14]**  | 297  **[REGN_3395643_7]**  | 288.6  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Praluent (U.S.)**      | 36  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 40  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 41  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 40  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 61  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | 70  **[0001804220-24-000015_exhibit991q12024.htm:14]**  | 56  **[0001804220-24-000026_exhibit991q22024.htm:2]**  | 52.9  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Evkeeza (U.S.)**       | 15  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 15  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 19  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 19  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 24  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | N/A     | 31  **[0001804220-24-000026_exhibit991q22024.htm:2]**  | 32.4  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Inmazeb (U.S.)**       | N/A     | 2  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 2  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 4  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 62  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | N/A     | N/A     | 35.6  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Total Net Product Sales** | 1,699  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 1,668  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 1,772  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 1,786  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 1,852  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | N/A     | N/A     | 1,946.4  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Sanofi Collaboration Revenue** | 836  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 798  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 944  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 1,065  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 993  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | 910  **[0001804220-24-000015_exhibit991q12024.htm:2]**  | 1,146  **[0001804220-24-000026_exhibit991q22024.htm:15]**  | 1,263.4  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Bayer Collaboration Revenue** | 355  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 357  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 377  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 377  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 377  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | 356  **[0001804220-24-000015_exhibit991q12024.htm:2]**  | 375  **[0001804220-24-000026_exhibit991q22024.htm:15]**  | 390.8  **[0001804220-24-000040_regn-20240930.htm:42]**  |
| **Roche Collaboration Revenue** | 396  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 222  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | N/A     | N/A     | N/A     | N/A     | N/A     | 0.5  **[0001804220-24-000040_regn-20240930.htm:43]**  |
| **Other Revenue**        | 128  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 116  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 69  **[0001804220-23-000021_exhibit991q22023.htm:3]**  | 138  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 212  **[0001804220-24-000006_exhibit991q42023.htm:4]**  | 117  **[0001804220-24-000015_exhibit991q12024.htm:2]**  | N/A     | 114.2  **[0001804220-24-000040_regn-20240930.htm:3]**  |
| **Total Revenues**       | 3,414  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | 3,162  **[0001804220-23-000015_exhibit991q12023.htm:2]**  | 3,158  **[0001804220-23-000021_exhibit991q22023.htm:0]**  | 3,363  **[0001804220-23-000029_exhibit991q32023.htm:3]**  | 3,434  **[0001804220-24-000006_exhibit991q42023.htm:0]**  | 3,145  **[0001804220-24-000015_exhibit991q12024.htm:0]**  | 3,550  **[0001804220-24-000026_exhibit991q22024.htm:0]**  | 3,720.7  **[0001804220-24-000038_exhibit991q32024.htm:0]**  |

a9729104ba4ea51104f2cd00e4f79990707df96e1bfa52ade6afa67972fe643a

Adjustments for Non-Cash Items (USD, millions)

Stock-Based Compensation (USD, millions)

Changes in Working Capital (USD, millions)

Capital Expenditures (USD, millions)

Proceeds from / Repayments of Debt (USD, millions)

Share Repurchases (USD, millions)

Dividend Payments (USD, millions)

Net Change in Cash (USD, millions)

d1c956c08d8503c82ee6e39fdb4531bd1ca86e1aa3fa0f5a218e62f045ef26f1

| Metric [Unit: USD Million] | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|----------------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| Total Revenue              | **3,410**  **[0001804220-23-000005_exhibit991q42022.htm:4]**  | **3,162**  **[0001804220-23-000015_exhibit991q12023.htm:0]**  | N/A     | N/A     | N/A     | N/A     | N/A     | N/A     |
| U.S. Revenue               | N/A     | N/A     | N/A     | N/A     | **4,315.4**  **[0001804220-24-000006_exhibit991q42023.htm:19]**  | N/A     | N/A     | N/A     |
| ROW Revenue                | N/A     | N/A     | N/A     | N/A     | **1,486.1**  **[0001804220-24-000006_exhibit991q42023.htm:19]**  | N/A     | N/A     | N/A     |

277c5010db935359834b08f440a41eddfd26f85348024bba87eddd1b88701991

1. Given the FDA's anticipated delay in approving linvoseltamab due to unresolved findings at a third-party manufacturer, how will this impact your timelines and strategies for bringing linvoseltamab to market, and what steps are you taking to mitigate these delays?  **[REGN_3395643_2]** 

2. With the DOJ investigation alleging violation of the False Claims Act related to EYLEA's marketing practices, can you provide clarity on potential impacts to your marketing strategies and whether this has affected prescriber behavior or market dynamics, as indicated by lower volumes and prices?  **[REGN_3395643_17]** 

3. Despite your strong balance sheet, you haven't made significant acquisitions to leverage your commercial presence, particularly in eye diseases; are there plans to pursue acquisitions of novel blockbuster therapies to bolster your pipeline and capitalize on existing synergies?  **[REGN_3395643_18]** 

4. Could you elaborate on the commercial opportunity for your Factor XI programs, specifically detailing how the distinct profiles of your two antibodies might position you competitively in the $20 billion direct oral anticoagulant market, and what are your future development plans in this space?  **[REGN_3395643_19]** 

5. Regarding DUPIXENT's potential in treating food allergies, can you quantify the target patient population and discuss how the benefit-risk profile of your approach might allow for broader application beyond the most severe cases?  **[REGN_3395643_16]** 

71e0d9ba3b7119a83eddc06db2caef6acf414a288b83a4c5ceb0d02e02fa35d2

- Biocon Biologics Ltd: Competitor for EYLEA HD and EYLEA in the EU with Yesafili (aflibercept)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Novartis AG and Genentech/Roche: Competitors for EYLEA HD and EYLEA in the United States, EU, and Japan with Lucentis (ranibizumab injection)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Samsung Bioepis Co., Ltd. and Biogen Inc.: Competitors for EYLEA HD and EYLEA in the United States and EU with Byooviz (ranibizumab-nuna)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Xbrane Biopharma AB and Bausch + Lomb: Competitors for EYLEA HD and EYLEA in the EU with Ximluci (ranibizumab)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Formycon AG, Bioeq AG, Coherus BioSciences, Inc., and Teva Ltd.: Competitors for EYLEA HD and EYLEA in the United States and EU with Cimerli (ranibizumab-eqrn)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Genentech/Roche: Competitors for EYLEA HD and EYLEA in the United States with Susvimo (ranibizumab ocular implant) and Vabysmo (faricimab-svoa) in the United States, EU, and Japan  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Novartis AG: Competitor for EYLEA HD and EYLEA in the United States, EU, and Japan with Beovu (brolucizumab) Injection  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Allergan/AbbVie Inc.: Competitor for EYLEA HD and EYLEA in the United States and EU with Ozurdex (dexamethasone intravitreal implant)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Alimera Sciences, Inc.: Competitor for EYLEA HD and EYLEA in the United States and EU with Iluvien (fluocinolone acetonide intravitreal implant)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Pfizer Inc.: Competitor for Dupixent in the United States and EU with Eucrisa/Staquis (crisaborole)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Incyte Corporation: Competitor for Dupixent in the United States with Opzelura (ruxolitinib)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Eli Lilly and Company/Incyte Corporation: Competitors for Dupixent in the EU and Japan with Olumiant (baricitinib)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Pfizer: Competitor for Dupixent in the United States, EU, and Japan with Cibinqo (abrocitinib)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- AbbVie: Competitor for Dupixent in the United States, EU, and Japan with Rinvoq (upadacitinib)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- LEO Pharma Inc.: Competitor for Dupixent in the United States, EU, and Japan with Adbry/Adtralza (tralokinumab)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Almirall S.A.: Competitor for Dupixent in the EU with Ebglyss (lebrikizumab)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Japan Tobacco Inc./Torii Pharmaceutical Co., Ltd.: Competitors for Dupixent in Japan with Corectim (delgocitinib)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd.: Competitors for Dupixent in Japan with Mitchga (nemolizumab)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- Roche/Novartis: Competitors for Dupixent in the United States, EU, and Japan with Xolair (omalizumab)  **[0001804220-24-000009_regn-20231231.htm:27]** .
- GlaxoSmithKline (GSK): Competitor for Dupixent in the United States, EU, and Japan with Nucala (mepolizumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- Teva: Competitor for Dupixent in the United States and EU with Cinqair (reslizumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- AstraZeneca: Competitor for Dupixent in the United States, EU, and Japan with Fasenra (benralizumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- AstraZeneca/Amgen: Competitors for Dupixent in the United States, EU, and Japan with Tezspire (tezepelumab-ekko)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- Merck & Co., Inc.: Competitor for Libtayo in the United States, EU, and Japan with Keytruda (pembrolizumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- Bristol-Myers Squibb: Competitor for Libtayo in the United States, EU, and Japan with Opdivo (nivolumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- Roche: Competitor for Libtayo in the United States, EU, and Japan with Tecentriq (atezolizumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- AstraZeneca: Competitor for Libtayo in the United States, EU, and Japan with Imfinzi (durvalumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- Pfizer/Merck KGaA: Competitors for Libtayo in the United States, EU, and Japan with Bavencio (avelumab)  **[0001804220-24-000009_regn-20231231.htm:28]** .
- GSK: Competitor for Libtayo in the United States and EU with Jemperli (dostarlimab)  **[0001804220-24-000009_regn-20231231.htm:28]** .

95cbba235a2aa97e1adb824c91a3d0635eb5004395bc4a32e054555f60d04cb7

feb529b00c19e978d35858589218ce80a4aaf976e05a8cf699b804c5acd74c47

41c4842a08403f1b1cae568848fda1df96c11e87904fcf151cd337cf10da1ae3

EYLEA HD and EYLEA

- U.S.

- ROW

Dupixent

Libtayo

Praluent

Kevzara

REGEN-COV

Other Products

Total Revenue

971564a83bf4fb870f3f2be842487e02eb11762b88c6b3d98ff8b0402ccf0c13

### Q2 2024 Earnings Call
- **Issued Period**: Q2 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Gross Margin**: Expected to be approximately **89%**, reflecting anticipated changes in product mix and higher non-product specific costs, including start-up costs for their fill/finish facility  **[REGN_3395643_9]** .
  2. **Sanofi Development Balance**: Anticipated to be fully reimbursed to Sanofi by the end of **2026**  **[REGN_3395643_9]** .

### Q1 2024 Earnings Call
- **Issued Period**: Q1 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **R&D Expense**: Expected to be in the range of **$4.4 billion to $4.6 billion**, due to the inclusion of operating expenses associated with the acquisition of 2seventy bio development programs  **[REGN_3382086_11]** .
  2. **U.S. Net Sales of Praluent**: Expected to be modestly higher in 2024 compared to 2023, primarily due to a gross to net adjustment related to a true-up of rebates due to an adverse change in payer coverage  **[REGN_3382086_11]** .

### Q4 2023 Earnings Call
- **Issued Period**: Q4 2023
- **Guided Period**: FY 2024
- **Guidance**:
  1. **R&D Expense**: Expected to be in the range of **$4.3 billion to $4.5 billion**  **[REGN_3371747_10]** .
  2. **SG&A Expense**: Expected to be in the range of **$2.5 billion to $2.65 billion**  **[REGN_3371747_10]** .
  3. **COCM (Cost of Collaboration Manufacturing)**: Expected to be in the range of **$850 million to $910 million**  **[REGN_3371747_10]** .
  4. **Gross Margin on Net Product Sales**: Expected to be in the range of **89% to 91%**  **[REGN_3371747_10]** .
  5. **Effective Tax Rate**: Expected to be in the range of **10% to 12%**  **[REGN_3371747_10]** .
  6. **Capital Expenditures**: Expected to be in the range of **$825 million to $950 million**  **[REGN_3371747_10]** .
  7. **U.S. Net Product Sales of Praluent**: Expected to be lower in 2024 compared to 2023 due to changes in payer coverage  **[REGN_3371747_10]** .
  8. **Net Product Sales for Inmazeb**: Expected to be in line with 2023 revenues, with nearly all 2024 revenues expected to be recorded in the fourth quarter  **[REGN_3371747_10]** .
  9. **Other Revenue**: Expected to be in line with 2023, with the second half expected to be higher than the first half  **[REGN_3371747_10]** .

### Q3 2024 Earnings Call
- **Issued Period**: Q3 2024
- **Guided Period**: N/A
- **Guidance**: The documents do not provide information on the guidance given during Regeneron's Q3 2024 earnings call. The available data only covers up to Q2 2024.

6e24b23bf9a636a01e04c5a045e75717bf6bd704240b2b9b93007b1186ec461e

9b3ed2833599a2a1798b0a12492b5d8a3f0ed05915eb061d85a32e923d018788

| Name                     | Position                                                                 | Start Date     | Short Bio                                                                                                                                                                                                                                                                                                                                                       |
|--------------------------|--------------------------------------------------------------------------|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Leonard S. Schleifer     | Board co-Chair, President, and Chief Executive Officer                   | 1988           | Leonard S. Schleifer, M.D., Ph.D., is the **founder of Regeneron Pharmaceuticals, Inc.**, having established the company in **1988**. He has served as a director and its President and Chief Executive Officer since its inception. Dr. Schleifer was the Chair of the Board from 1990 through 1994 and has been the Co-Chair of the Board since June 2023  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:95]** **[0001308179-24-000577_lregn2024_def14a.htm:19]** **[0001308179-24-000577_lregn2024_def14a.htm:44]** . |
| George D. Yancopoulos    | Board co-Chair, President, and Chief Scientific Officer                  | 1989           | George D. Yancopoulos, M.D., Ph.D., joined Regeneron in **1989** as the founding scientist alongside Dr. Leonard S. Schleifer. He has been instrumental in building and managing the company since then. Dr. Yancopoulos has served as a director since **2001** and became Co-Chair of the Board in **June 2023**  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:99]** **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:95]** **[0001308179-24-000577_lregn2024_def14a.htm:20]** **[0001308179-24-000577_lregn2024_def14a.htm:44]** .                                    |
| Christopher Fenimore     | Senior Vice President, Finance and Chief Financial Officer               | February 2024  | Christopher Fenimore has been serving as the **Senior Vice President, Finance and Chief Financial Officer** at Regeneron Pharmaceuticals, Inc. since **February 2024**. Prior to this role, he was the Senior Vice President, Controller from January 2021 to February 2024  **[0001308179-24-000577_lregn2024_def14a.htm:44]** **[0001804220-24-000020_filename1.htm:10]** .                                                                                |
| Jason Pitofsky           | Vice President, Controller                                               | February 2024  | Jason Pitofsky, **47**, has been the **Vice President, Controller** at Regeneron Pharmaceuticals, Inc. since **February 2024**. Prior to this role, he served as Vice President, Accounting and Financial Reporting from January 2021 to February 2024  **[0001308179-24-000577_lregn2024_def14a.htm:46]** **[0001104659-24-012275_xslF345X02/tm245325-1_3seq1.xml:0]** .                                                                                                    |
| Neil Stahl               | Executive Vice President, Research and Development                       | January 2015   | Neil Stahl, Ph.D., is the Executive Vice President, Research and Development at Regeneron Pharmaceuticals, Inc. He has held this position since **January 2015**. Dr. Stahl joined Regeneron in **1991** and has served in various roles, including Senior Vice President, Research and Development Sciences from **January 2007 to December 2014**  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:96]** **[0001308179-24-000577_lregn2024_def14a.htm:46]** **[0001308179-23-000728_lregn2023_def14a.htm:32]** .       |
| Daniel P. Van Plew       | Executive Vice President and General Manager, Industrial Operations and Product Supply | January 2016   | Daniel P. Van Plew has been the **Executive Vice President and General Manager, Industrial Operations and Product Supply** at Regeneron Pharmaceuticals since **January 2016**. He joined the company in **2007** as Vice President and General Manager, Industrial Operations and Product Supply  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:97]** **[0001308179-24-000577_lregn2024_def14a.htm:46]** **[0001308179-23-000728_lregn2023_def14a.htm:32]** .                                                    |
| Joseph J. LaRosa         | Executive Vice President, General Counsel and Secretary                  | January 2019   | Joseph J. LaRosa, **65**, has been the **Executive Vice President, General Counsel, and Secretary** at Regeneron Pharmaceuticals, Inc. since **January 2019**. Prior to this role, he served as Senior Vice President, General Counsel, and Secretary from **September 2011 to December 2018**  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:96]** **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:100]** **[0001104659-23-093555_tm2324112d1_sc13d.htm:9]** .                                                        |
| Marion McCourt           | Executive Vice President, Commercial                                     | January 2021   | Marion McCourt, **63**, has been the **Executive Vice President, Commercial** at Regeneron Pharmaceuticals, Inc. since **January 2021**. She previously served as Senior Vice President, Commercial from February 2018 to December 2020  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:96]** **[0001308179-24-000577_lregn2024_def14a.htm:45]** **[0001308179-23-000728_lregn2023_def14a.htm:32]** .                                                                                                              |
| Andrew J. Murphy         | Executive Vice President, Research                                       | January 2019   | Andrew J. Murphy, Ph.D., has been serving as **Executive Vice President, Research** at Regeneron Pharmaceuticals, Inc. since **January 2019**. Prior to this role, he was the Senior Vice President, Research, Regeneron Laboratories from January 2013 to December 2018  **[0001104659-23-095116_tm2324731d1_ex99-a1a.htm:96]** **[0001308179-24-000577_lregn2024_def14a.htm:45]** **[0001308179-23-000728_lregn2023_def14a.htm:32]** .                                                                              |

a17479a5e18e91bfd095baeaee5176a70e45f26d56fb69812f3bf13fa0010177

| Program Details            | Program 1             | Program 2             |
|----------------------------|-----------------------|-----------------------|
| Approval Date              | January 2023  **[0001804220-24-000040_regn-20240930.htm:50]** **[0001804220-24-000040_regn-20240930.htm:13]**    | April 2024  **[0001804220-24-000040_regn-20240930.htm:50]**         |
| End Date/Duration          | Completed by September 30, 2024  **[0001804220-24-000040_regn-20240930.htm:50]** **[0001804220-24-000040_regn-20240930.htm:13]**  | No time limit  **[0001804220-24-000040_regn-20240930.htm:50]**  |
| Total additional amount    | **$3.0 billion**  **[0001804220-24-000040_regn-20240930.htm:50]** **[0001804220-24-000040_regn-20240930.htm:13]**  | **$3.0 billion**  **[0001804220-24-000040_regn-20240930.htm:50]**   |
| Remaining authorization amount | **$0**  **[0001804220-24-000040_regn-20240930.htm:50]** **[0001804220-24-000040_regn-20240930.htm:13]**        | **$2.893 billion**  **[0001804220-24-000040_regn-20240930.htm:50]** **[0001804220-24-000040_regn-20240930.htm:13]**  |
| Details                    | Entire amount repurchased  **[0001804220-24-000040_regn-20240930.htm:50]** **[0001804220-24-000040_regn-20240930.htm:13]**  | Can be discontinued at any time  **[0001804220-24-000040_regn-20240930.htm:50]**  |

c3ef5c855432a9e02f5b6f635cf680314f2b9a0c1790d09d8127ec29d7d13b8b

| Name                        | Start Date | End Date | Reason for Change |
|-----------------------------|------------|----------|-------------------|
| PricewaterhouseCoopers LLP  | 1989  **[0001804220-24-000009_regn-20231231.htm:165]**  | Present  | Current auditor   |

09ffc2a1a6ad8c7316d51265aed555b7f724561587fad8bd01308f198558c47e

cecc465563575de9db2692bd54f84bb7516028a588ca9e064409bb0c39d0567d

81fcc058a7971ff6bbfd41a5412140c81ff5a3159e39af84601a62ba162dfa0d

0e8084d0eafc71b2fee3dc777fe8ef7ee18d203c6b5651bbfffa821e26ad4019

1. **EYLEA HD Uptake**  
   **Q:** What factors will accelerate EYLEA HD conversion?  
   **A:** The early performance of **EYLEA HD** is encouraging, driven by clinical data showing efficacy, safety, and durability. Key factors that will accelerate conversion include physicians building on their early experience, the upcoming permanent **J-code** expected on **April 1**  **[REGN_3371747_11]** , and progress in **payer coverage**.  **[REGN_3371747_11]**  Reimbursement confidence is very important, as some physicians hesitate to prescribe without a permanent J-code.  **[REGN_3371747_11]** 

2. **Obesity Program Differentiation**  
   **Q:** How does your obesity portfolio stand out?  
   **A:** Our obesity program is unique because we discovered two key ligands controlling muscle size, **Myostatin 1 and Myostatin 2**, and have specific blocking antibodies for both.  **[REGN_3371747_12]**  We're testing them individually and together to achieve muscle preservation during GLP-1 agonist treatment, while also ensuring safety.  **[REGN_3371747_12]**  We're also developing **unimolecular solutions** combining tethered GLP-1 with antibodies for potential **once-a-month dosing**.  **[REGN_3371747_12]** 

3. **EYLEA Pricing Outlook**  
   **Q:** Do you expect further price erosion for 2 mg EYLEA?  
   **A:** We view the market as very competitive, and there has been some **price erosion** on products.  **[REGN_3371747_14]**  With **EYLEA HD**, we believe we priced it well and it was received positively, matching on a yearly basis.  **[REGN_3371747_14]**  We don't want to comment specifically on future pricing strategies.  **[REGN_3371747_14]** 

4. **Linvoseltamab Commercialization**  
   **Q:** How will you convert prescribers to linvoseltamab?  
   **A:** It starts with a **best-in-class molecule**; it's about the science.  **[REGN_3371747_18]**  We've successfully launched into competitive categories before, like with **EYLEA** displacing **Lucentis**, and we're confident we can do it again with strong execution.  **[REGN_3371747_18]**  Our oncology team is well-prepared, and we're excited to help patients with **linvoseltamab**.  **[REGN_3371747_18]** 

5. **Capital Allocation Plans**  
   **Q:** How will you use the growing cash balance?  
   **A:** Our top priority is to fully fund **research and development**, with **8 to 10 INDs** coming.  **[REGN_3371747_16]**  We're proud of our **buybacks** and will continue our methodology.  **[REGN_3371747_16]**  Regarding business development, we'll remain prudent; any moves must fit our **franchise** and **modalities**, and be incremental to our current pipeline.  **[REGN_3371747_16]** 

6. **Anti-VEGF Market Trends**  
   **Q:** How is the anti-VEGF market trending?  
   **A:** The anti-VEGF category is overall healthy from a growth standpoint, driven by the number of individuals with diabetes and an aging population.  **[REGN_3371747_13]**  There's variability between quarters and years, and recently there has been a **decline of a couple of points** between last year and this year.  **[REGN_3371747_13]** 

7. **Muscle-Sparing Myostatin Program**  
   **Q:** Concerns about muscle function with myostatin targeting?  
   **A:** Our studies show that the muscle is **functional** and important for metabolic and energy expenditure.  **[REGN_3371747_15]**  There's variety in regulatory pathways; if we see **increased weight loss**, that might suffice as a strategy, or we might need to show **functional outcomes** in strength.  **[REGN_3371747_15]**  Results from initial studies over the next **year to 1.5 years** will inform our path.  **[REGN_3371747_15]** 

8. **Geographic Atrophy Program**  
   **Q:** Why confidence in systemic approach for GA?  
   **A:** We believe we have the most effective way of blocking **C5 activity** by targeting it systemically, as C5 comes from the liver.  **[REGN_3371747_17]**  Our Phase III **PNH studies** showed **best-in-class activity** in decreasing C5.  **[REGN_3371747_17]**  Blocking at the source avoids local side effects like **retinal vasculitis**, but we need strategies to mitigate increased infection risks in the elderly.  **[REGN_3371747_17]** 

9. **2seventy Deal Implications**  
   **Q:** How does the 2seventy deal affect your strategy?  
   **A:** We've been long-standing partners with 2seventy, and now we're excited to combine our large portfolio of **biologics in immunotherapy** with their **cell therapy capabilities**.  **[REGN_3371747_19]**  This allows us to pioneer new **combination approaches** against cancer, bringing a new level to the immunotherapy field.  **[REGN_3371747_19]**  We believe we'll be unique in this capability.  **[REGN_3371747_19]** 

67ed2ddcab8aeffea7a166dab5f6ec172207322df8bd704503a82ec872c4b08c

- **Challenges in launching Dupixent for COPD due to required physician education and competition.** The need to educate physicians in a new space for biologics might affect initial uptake of Dupixent, and other biologics showing promise could impact its long-term market positioning.  **[REGN_3382086_20]**
- **Regulatory uncertainty regarding acceptable endpoints for muscle-sparing obesity treatments.** FDA's acceptance of endpoints beyond weight loss is uncertain, potentially complicating development and approval of Regeneron's muscle-sparing obesity program.  **[REGN_3382086_13]**
- **Difficulty differentiating muscle-sparing obesity program amid competition.** Competitors have muscle-sparing programs, and Regeneron may face challenges in differentiating its approach from others.  **[REGN_3382086_12]**

c7aa2f821c2dc82970ec23af546acf16111434f2ecb5a5b4440544199e61f028

1. **EYLEA HD Market Share and Growth**  
   **Q:** Is EYLEA HD mature enough to stabilize market share and growth?  
   **A:** Management reports **$1.54 billion** in total net sales this quarter, a **2.4% increase year-over-year**.  **[REGN_3395643_10]**  EYLEA HD net sales increased by **52%**, adding **$100 million** from the prior quarter.  **[REGN_3395643_10]**  They are encouraged by switches from competitors and note that use in treatment-naive patients **doubled from the prior quarter**  **[REGN_3395643_22]** , suggesting EYLEA HD could become the new standard of care.  **[REGN_3395643_10]** **[REGN_3395643_22]**  Overall market growth is tracking mid single-digits, not 10%.  **[REGN_3395643_10]** 

2. **EYLEA HD Access Barriers and J-code**  
   **Q:** How are access barriers impacting EYLEA HD post permanent J-code?  
   **A:** Management states that for fee-for-service Medicare patients, there's open access.  **[REGN_3395643_14]**  In areas with payer impact, they've secured coverage for over **80% of patient lives**.  **[REGN_3395643_14]**  While some utilization management exists, they are addressing these issues.  **[REGN_3395643_14]**  Overall, EYLEA HD has strong payer coverage.  **[REGN_3395643_14]** 

3. **linvoseltamab Launch and Manufacturing Issues**  
   **Q:** Can you elaborate on linvo's launch prep and third-party facility issues?  
   **A:** FDA observations at a third-party filler for a different product require reinspection, likely delaying linvoseltamab's approval past the PDUFA date.  **[REGN_3395643_12]**  Management believes the issues have been remediated and is working with the FDA for a quick resolution.  **[REGN_3395643_12]**  They emphasize linvo's differentiated efficacy and safety profile and plan to move into earlier lines of therapy.  **[REGN_3395643_12]** 

4. **Factor XI Program Development and Opportunity**  
   **Q:** Can you discuss your Factor XI antibodies and their potential?  
   **A:** Regeneron has two best-in-class antibodies targeting different parts of Factor XI to optimize efficacy and safety profiles.  **[REGN_3395643_13]**  They expect proof-of-concept data by year's end to decide directions.  **[REGN_3395643_13]** **[REGN_3395643_19]**  With the **$20 billion** anticoagulant market in mind, they aim to deliver similar or better efficacy with improved safety.  **[REGN_3395643_19]** 

5. **DOJ Investigation into EYLEA Marketing Practices**  
   **Q:** Has the DOJ investigation affected practices or prescribers?  
   **A:** Management asserts there's nothing to the lawsuit, they've not changed their practices, and intend to fight it vigorously.  **[REGN_3395643_17]**  They see no market impact related to this issue.  **[REGN_3395643_17]** 

6. **Obesity Program with Leptin Combination**  
   **Q:** What's the rationale for leptin Phase II with tirzepatide?  
   **A:** Regeneron believes that after weight loss, falling leptin levels may drive increased feeding behavior.  **[REGN_3395643_11]**  By adding leptin to tirzepatide, they aim to overcome weight loss plateaus and achieve further weight loss.  **[REGN_3395643_11]**  Studies are in collaboration with Lilly.  **[REGN_3395643_11]** 

7. **Potential Acquisitions in Eye Disease**  
   **Q:** Are there opportunities to acquire novel therapies for eye disease?  
   **A:** Management considers opportunities daily but currently sees no large-scale acquisitions that fit their strategy.  **[REGN_3395643_18]**  They remain open to leveraging their capabilities but find no significant late-stage products to acquire at this time.  **[REGN_3395643_18]** 

8. **DUPIXENT in Food Allergy Market**  
   **Q:** How many patients could benefit if data supports DUPIXENT for food allergy?  
   **A:** The potential market is large, starting with the most severe food-allergic patients.  **[REGN_3395643_16]**  If proven safe and effective, the treatment could expand to milder allergies, benefiting patients already using DUPIXENT for other allergic diseases.  **[REGN_3395643_16]**  Management notes the numbers could be staggering, with hundreds of thousands of emergency visits for food-based allergies annually.  **[REGN_3395643_16]** 

9. **EYLEA HD Conversion and Uptake**  
   **Q:** How should we think about EYLEA HD conversion pace and uptake?  
   **A:** Management is pleased with progress, noting that utilization among treatment-naive patients **doubled from the prior quarter**.  **[REGN_3395643_22]**  They are seeing ongoing switches from EYLEA, faricimab, and Avastin, with increased use in naive patients.  **[REGN_3395643_22]**  They continue to see EYLEA HD prescribing evolve positively.  **[REGN_3395643_22]** 

10. **VABYSMO Pre-filled Syringe Competition**  
    **Q:** Will EYLEA HD launch momentum be disrupted by VABYSMO's pre-filled syringe?  
    **A:** Management anticipates launching their own pre-filled syringe in early **2025**, only months apart from competition.  **[REGN_3395643_20]**  They believe this won't significantly impact the market, as physicians focus on EYLEA HD's profile, durability, and established safety.  **[REGN_3395643_20]** 

11. **Myostatin Program and Combination Approach**  
    **Q:** What's your preference for doublet vs. triplet in myostatin trials?  
    **A:** Regeneron aims to optimize pathways by precisely dissecting mechanisms.  **[REGN_3395643_15]**  They focus on combining weight loss agents with myostatin pathway blockers to maximize fat loss while preserving muscle.  **[REGN_3395643_15]**  Their approach may provide a safer and more effective solution than other methods.  **[REGN_3395643_15]** 

67b9b1f82e74de75f359145b090f587dc7b51ebaa8ff90ae9e0b8dd287756094

- **EYLEA HD is experiencing strong early uptake**, with positive feedback from physicians and patients, including switches from competitors like Vabysmo and Avastin, indicating **EYLEA HD's potential to become the new standard of care**.  **[REGN_3363587_14]**
- **Regeneron has a robust financial position with over $15 billion in cash and marketable securities**, enabling continued investment in R&D and strategic acquisitions, as well as share repurchases, which can drive shareholder value.  **[REGN_3363587_10]**
- **Promising progress in their cancer portfolio**, particularly the combination of **Libtayo and fianlimab** in first-line metastatic melanoma, which may provide a significant advance for patients and open up opportunities in other cancer indications.  **[REGN_3363587_18]**

2738178254edda131a3bddbc163149f65cc4436c2ed3706ab0131ab77b352084

- **EYLEA HD is experiencing strong launch momentum, with net sales increasing by 52% sequentially in its third full quarter, and continues to gain market share, including among treatment-naive patients whose usage doubled from the prior quarter.**  **[REGN_3395643_10]** **[REGN_3395643_22]**
- **The EYLEA franchise has maintained its leading 45% category share despite increased competition, demonstrating Regeneron's strong market position in retinal diseases.**  **[REGN_3395643_10]**
- **Regeneron's Factor XI programs have the potential to tap into the $20 billion anticoagulant market by offering similar or better efficacy with improved safety profiles, representing a significant future growth opportunity.**  **[REGN_3395643_19]**

561f7c757f8c5a9b93efc9af78a069c69ce480f82c12ea6853e0511e582ff732

1. **Dupixent in COPD Approval**  
   **Q:** Could there be subpopulation restrictions for Dupixent in COPD?  
   **A:** Management believes the data supports approval of Dupixent for eosinophilic COPD without restrictions. They have conducted extensive analyses showing consistent and clinically meaningful reductions in COPD exacerbations across all subgroups and plan to submit these ahead of schedule.  **[REGN_3382086_15]** 

2. **Linvoseltamab Launch Strategy**  
   **Q:** How are you preparing for the linvoseltamab launch and earlier myeloma lines?  
   **A:** They are preparing for the potential launch of linvoseltamab with an **August 22 PDUFA date**, excited by recent data reinforcing it as potentially a best-in-class product for late-stage myeloma patients. Management is considering minimal residual disease (MRD) negativity as a surrogate endpoint to move into earlier lines of therapy faster.  **[REGN_3382086_22]** 

3. **Obesity Program Differentiation**  
   **Q:** How does your muscle-sparing obesity program differ from competitors?  
   **A:** Their program targets only two specific members of a large family involved in muscle preservation, potentially offering better safety by avoiding blocking over a dozen factors like competitors do. This selective approach aims to preserve muscle while increasing fat loss, improving weight loss quality.  **[REGN_3382086_12]** 

4. **Dupixent COPD Launch Preparation**  
   **Q:** Will physician education affect Dupixent's COPD launch and competition?  
   **A:** The team is experienced with Dupixent launches and is applying best practices for the COPD indication. Many physicians are already familiar with Dupixent's benefits. They aim to ensure reimbursement and affordability, anticipating strong uptake despite potential competition from other biologics.  **[REGN_3382086_20]** 

5. **EYLEA Inventory and Market Changes**  
   **Q:** Did market consolidation affect EYLEA inventory or strategy?  
   **A:** There was a **$40 million** reduction in wholesaler inventory due to a sequential drawdown of EYLEA, partly offset by an increase in EYLEA HD inventory ahead of a new J-Code. Management remains effective in addressing market evolution, including consolidation of retina practices by entities like McKesson.  **[REGN_3382086_14]** 

6. **Food Allergy Study Expectations**  
   **Q:** What do you expect from the initial severe food allergy study results?  
   **A:** They hope to see meaningful indicators of reversing severe food allergy by reducing IgE levels. Depending on results, they may proceed with allergen-challenge tests. Treatment duration with Dupixent could be short-term or longer, but it is considered safe and potentially beneficial for patients with atopic diseases.  **[REGN_3382086_16]** 

7. **Bispecifics in Autoimmune Diseases**  
   **Q:** Are you leveraging bispecific expertise in autoimmune conditions like lupus?  
   **A:** Yes, they are exploring bispecific antibodies in autoimmune diseases, comparing them directly to CAR-T approaches. Through their acquisition of 2seventy, they're conducting studies to assess efficacy and safety, believing bispecifics could be more convenient and safer than CAR-T therapies.  **[REGN_3382086_19]** 

8. **LAG-3 Program and Lung Cancer**  
   **Q:** How do Bristol's findings on PD-1 and LAG-3 affect your program?  
   **A:** They are excited about their own program's unprecedented activity in melanoma and hope it translates to other cancers, including lung cancer. They look forward to seeing more data from Bristol and comparing it within their studies, particularly in specific subpopulations.  **[REGN_3382086_17]** 

9. **Itepekimab's Disease Modification Potential**  
   **Q:** Could itepekimab offer disease modification in COPD beyond exacerbations?  
   **A:** Management believes there's potential for disease modification, similar to Dupixent in asthma. They are examining long-term preservation of lung function and prevention of lung capacity loss in COPD patients, which could indicate modifying the disease course.  **[REGN_3382086_21]** 

10. **Linvoseltamab in Food Allergy**  
    **Q:** How does linvoseltamab dosing in food allergy compare to myeloma?  
    **A:** They are starting at much lower doses than in myeloma, with an intrapatient dose escalation. They believe normal plasma cells are more susceptible, expecting better safety with lower doses. Missing a Dupixent dose likely doesn't require restarting treatment, as IgE levels take time to rebound.  **[REGN_3382086_18]** 

4f48577e4a4563d0a298b196815709fba263a539ba795617040bd008c257e0dc

- Regeneron is experiencing **price erosion and contracting revenues** for the 2mg EYLEA format due to increasing competition in the anti-VEGF market, which may negatively impact overall revenues.  **[REGN_3371747_14]**
- The anti-VEGF market may be **slowing down**, as management noted a **decline of a couple of points between last year and this year overall**, indicating potential challenges for market growth.  **[REGN_3371747_13]**
- **Adoption of EYLEA HD may be hindered** until a permanent J-code for reimbursement is effective on April 1, with physicians hesitant to prescribe without it, potentially affecting near-term sales.  **[REGN_3371747_11]**

1a86ad343c92f938d6bc8493d4a00059cae8e8c7e6c9937f4b15c4d6010fe647

- **Linvoseltamab**, Regeneron's potential **best-in-class** product for late-stage myeloma patients, has an upcoming **PDUFA date on August 22**. The company is preparing for its potential launch, which could extend their oncology franchise into a new disease area.  **[REGN_3382086_22]**
- Regeneron is preparing for the potential launch of **Dupixent in COPD**, addressing significant unmet needs in **eosinophilic COPD** patients. Their experienced team is confident in helping these patients and building on their success in asthma.  **[REGN_3382086_20]**
- Regeneron is confident that **Dupixent** shows a **consistent and clinically meaningful reduction in COPD exacerbations across all subgroups**, supporting broad approval for **eosinophilic COPD**.  **[REGN_3382086_15]**

85bb1410910376522d62d4194156789123815eebccc4ba6f32c51d162634e1b0

- **Regeneron may be missing growth opportunities by not pursuing large-scale acquisitions despite having a strong balance sheet**, particularly in the eye disease area where substantial external innovation is happening.  **[REGN_3395643_18]**
- **Potential delays in the approval and launch of linvoseltamab due to third-party manufacturing issues**, including FDA reinspection requirements, could impact near-term revenue growth.  **[REGN_3395643_12]**
- **The retinal disease market is growing at mid-single digits rather than the expected 10%**, which could limit the growth potential of EYLEA HD and the overall EYLEA franchise.  **[REGN_3395643_10]**

9840544165cc519b6c82078883c72ea7138a5df5808e654b540ae52be8b10ff3

- **EYLEA HD is experiencing positive early adoption with significant physician confidence**, driven by real-world data showing efficacy, safety, and durability. Anticipated factors such as the forthcoming **permanent J-code on April 1** are expected to accelerate its uptake by enhancing reimbursement confidence among physicians.  **[REGN_3371747_1]**
- **The anti-VEGF market remains healthy with growth opportunities**, supported by increasing numbers of individuals diagnosed with diabetes and an aging population, which bodes well for EYLEA and EYLEA HD demand.  **[REGN_3371747_11]**
- **Regeneron's innovative obesity pipeline**, including the muscle-sparing myostatin program and targeting of the **GPR75 receptor**, has shown promising preclinical and early clinical results, with potential to significantly impact the obesity market in the next **1 to 1.5 years**.  **[REGN_3371747_14]**

a79d21c8a1648fa8b7d3b41652dea827f16a7160d9d8b8b47e23ea68e162a4f4

- **Regeneron is facing potential loss of exclusivity for EYLEA due to ongoing patent litigation**, with the base case assuming exclusivity will expire in May, which could negatively impact the EYLEA franchise if the court ruling is unfavorable.  **[REGN_3363587_21]** **[REGN_3363587_15]**
- **There is increasing competitive pressure on EYLEA from biosimilar products**, such as ranibizumab biosimilars, leading to pricing pressure and potential market share erosion. EYLEA has experienced "some pressure" and "modest rebating and discounting" in response to competition.  **[REGN_3363587_21]** **[REGN_3363587_19]**
- **The company's large cash balance ($15 billion) may not be effectively utilized to drive higher returns**, as management indicated reluctance to pursue acquisitions that may not give optimal results, which could suggest underutilization of capital.  **[REGN_3363587_10]** **[REGN_3363587_9]**

861c71d40b2776031a5dee4f3be3503974cee78bd388d1f670e34053492f4f4c

1. **EYLEA vs. Biosimilars**  
   **Q:** How will biosimilars affect EYLEA, and plans for EYLEA HD?  
   **A:** Management expressed confidence in EYLEA's strong performance and safety record, noting it has delivered around **100 million injections**.  **[REGN_3405018_10]**  They acknowledge the entry of a biosimilar but believe **EYLEA HD** is a differentiated product that will compete well.  **[REGN_3405018_10]**  They plan to continue educating doctors about its benefits and are providing more data, including long-term results that are "rather striking".  **[REGN_3405018_10]** 

2. **EYLEA HD Prefilled Syringe Launch**  
   **Q:** What impact will the EYLEA HD prefilled syringe have?  
   **A:** They anticipate launching the **EYLEA HD prefilled syringe by mid-next year**, expecting it to be a catalyst for acceleration.  **[REGN_3405018_12]**  Doctors prefer prefilled syringes, and they believe their product will be differentiated due to its design to withstand millions of injections without causing inflammation, an issue seen with competitors.  **[REGN_3405018_11]** **[REGN_3405018_12]** 

3. **Pricing Pressure on EYLEA HD**  
   **Q:** Explain the pricing pressures on EYLEA HD and future outlook.  
   **A:** Management acknowledges pricing pressure in the anti-VEGF category affecting all products, including EYLEA HD.  **[REGN_3405018_16]**  They attribute this to competitive factors consistent with other markets but believe EYLEA HD's clinical profile, safety, and durability position it well to compete successfully despite these pressures.  **[REGN_3405018_16]** 

4. **Capital Allocation Amid Biosimilar Entry**  
   **Q:** How will biosimilar competition influence capital allocation?  
   **A:** They will not adjust spending based on biosimilar entry.  **[REGN_3405018_13]**  The company intends to continue investing appropriately based on opportunities, emphasizing their strong balance sheet and commitment to bringing innovative products to market rather than focusing on biosimilars.  **[REGN_3405018_13]** 

5. **Obesity Program Trial Expansion**  
   **Q:** Why expand the obesity trial with new arms?  
   **A:** They added additional dosing arms to explore different doses aimed at **muscle preservation**, intending to find the right mix to maximize the quality of weight loss.  **[REGN_3405018_19]**  This expansion allows for broader information on dosing and effects.  **[REGN_3405018_19]** 

6. **Regulatory Path for Muscle Preservation**  
   **Q:** Discuss the regulatory path for muscle-preserving obesity treatments.  
   **A:** Management aims to maintain muscle while increasing weight loss, recognizing the significant **loss of lean body mass** with current GLP treatments.  **[REGN_3405018_20]**  The simplest regulatory path is demonstrating increased weight loss with better composition, supported by metabolic and functional improvements.  **[REGN_3405018_20]** 

7. **Factor XI Program Expectations**  
   **Q:** What are the expectations for the upcoming Factor XI readouts?  
   **A:** They are excited about their **Factor XI program**, which they believe is different from competitors' approaches.  **[REGN_3405018_14]**  With two distinct antibodies offering different efficacy and safety profiles, they see potential for multiple indications, considering it a pipeline in itself.  **[REGN_3405018_14]** 

8. **Next-Generation DUPIXENT Efforts**  
   **Q:** Are there efforts to develop a next-gen DUPIXENT?  
   **A:** The company is constantly working on improving existing products like DUPIXENT and developing entirely new approaches, aiming to improve current treatments and offer **next-generation solutions**.  **[REGN_3405018_21]** 

9. **Impact of Avastin Supply Issues**  
   **Q:** How does the Avastin supply issue affect EYLEA?  
   **A:** They are aware of supply issues with Avastin but have not yet seen a material uptake in EYLEA HD or EYLEA.  **[REGN_3405018_15]**  They believe physicians' confidence in EYLEA's clinical profile will position it well if Avastin plays a lesser role.  **[REGN_3405018_15]** 

10. **Rate of Biosimilar Erosion Comparison**  
    **Q:** Is Lucentis' biosimilar erosion a proxy for EYLEA's future?  
    **A:** Management believes it's too early to compare and that the situation is different due to EYLEA HD's differentiated profile and physicians' experience with EYLEA.  **[REGN_3405018_22]**  They emphasize the significant differences in commercial dynamics.  **[REGN_3405018_22]** 

11. **Capital Allocation Priorities (Dividend)**  
    **Q:** Thoughts on share repurchases or dividends?  
    **A:** While they discuss capital allocation internally, they have nothing more to add publicly.  **[REGN_3405018_23]**  They consider that the best time to think about a dividend might be after paying off the development balance to Sanofi, expected around the **end of 2026**.  **[REGN_3405018_23]** 

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Regeneron Pharmaceuticals Inc (REGN)

Financials