3a0b720bc4a9e49dc704022e8aa0d8520a1ba1dfeca43501b344e2562f96539c

| Metric [Unit: USD Million] | Q4 2022 | Q1 2023 | Q2 2023 | Q3 2023 | Q4 2023 | Q1 2024 | Q2 2024 | Q3 2024 |
|----------------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| **Total Revenue**          | **5,100**  **[0001682852-23-000008_exhibit9912022q4pressrelea.htm:2]**  | **1,900**  **[0001682852-23-000018_exhibit9912023q1pressrelea.htm:3]**  | **344**  **[0001682852-23-000025_exhibit9912023q2pressrelea.htm:2]**  | **1,831**  **[0001682852-23-000042_mrna-20230930.htm:36]**  | **2,800**  **[0001682852-24-000010_exhibit9912023q4pressrelea.htm:2]**  | **167**  **[0001682852-24-000023_exhibit9912024q1pressrelea.htm:1]**  | **241**  **[0001682852-24-000043_exhibit9912024q2pressrelea.htm:1]**  | **1,900**  **[0001682852-24-000057_exhibit9912024q3pressrelea.htm:1]**  |
| **Net Product Sales**      | **4,900**  **[0001682852-23-000008_exhibit9912022q4pressrelea.htm:2]**  | **1,800**  **[0001682852-23-000018_exhibit9912023q1pressrelea.htm:3]**  | **293**  **[0001682852-23-000025_exhibit9912023q2pressrelea.htm:2]**  | **1,757**  **[0001682852-23-000042_mrna-20230930.htm:36]**  | **N/A** | **167**  **[0001682852-24-000023_exhibit9912024q1pressrelea.htm:1]**  | **184**  **[0001682852-24-000043_exhibit9912024q2pressrelea.htm:0]** **[MRNA_3395662_3]** **[0001682852-24-000046_mrna-20240630.htm:28]**  | **1,820**  **[0001682852-24-000057_exhibit9912024q3pressrelea.htm:1]**  |
| - COVID-19 Vaccine Sales   | **N/A** | **1,800**  **[0001682852-23-000018_exhibit9912023q1pressrelea.htm:3]**  | **293**  **[0001682852-23-000025_exhibit9912023q2pressrelea.htm:2]**  | **1,800**  **[0001682852-23-000038_exhibit9912023q3pressrelea.htm:2]**  | **N/A** | **167**  **[0001682852-24-000023_exhibit9912024q1pressrelea.htm:1]**  | **184**  **[0001682852-24-000043_exhibit9912024q2pressrelea.htm:0]** **[MRNA_3395662_3]** **[0001682852-24-000046_mrna-20240630.htm:28]**  | **1,810**  **[0001682852-24-000057_exhibit9912024q3pressrelea.htm:1]**  |
| - RSV Vaccine Sales        | **N/A** | **N/A** | **N/A** | **N/A** | **N/A** | **N/A** | **N/A** | **10**  **[0001682852-24-000057_exhibit9912024q3pressrelea.htm:1]**  |
| **Other Revenue**          | **N/A** | **34**  **[0001682852-23-000018_exhibit9912023q1pressrelea.htm:3]**  | **51**  **[0001682852-23-000027_mrna-20230630.htm:33]**  | **74**  **[0001682852-23-000042_mrna-20230930.htm:36]**  | **N/A** | **N/A** | **57**  **[MRNA_3395662_3]**  | **42**  **[0001682852-24-000060_mrna-20240930.htm:12]**  |

728ab0c6c5e1fcbee4e860d9184f1f9aac0068c387c01fc4b0bef51cf75e181f

Total Revenue (USD, millions)

Cost of Goods Sold (COGS) (USD, millions)

Selling, General, and Administrative Expenses (SG&A) (USD, millions)

Research and Development (R&D) (USD, millions)

Depreciation and Amortization (D&A) (USD, millions)

Interest Expense (USD, millions)

Operating Income (EBIT) (USD, millions)

Net Income (USD, millions)

Earnings Per Share (EPS) - Basic (USD)

Earnings Per Share (EPS) - Diluted (USD)

0b4779089635f16a718231a139133c6977a14b313265f946afddb23b16ec49a0

| Geographical Segment | Q4 2023 | Q3 2023 | Q2 2023 | Q1 2023 | Q4 2022 | Q3 2024 | Q2 2024 | Q1 2024 |
|----------------------|---------|---------|---------|---------|---------|---------|---------|---------|
| **United States** ($ million) | **800**  **[MRNA_3374538_2]**  | **913**  **[0001682852-23-000042_mrna-20230930.htm:10]** **[0001682852-23-000042_mrna-20230930.htm:36]**  | **2**  **[0001682852-23-000027_mrna-20230630.htm:10]**  | **1**  **[0001682852-23-000021_mrna-20230331.htm:9]**  | N/A | **1,215**  **[0001682852-24-000060_mrna-20240930.htm:29]**  | **162**  **[0001682852-24-000046_mrna-20240630.htm:11]**  | **100**  **[0001682852-24-000027_mrna-20240331.htm:25]**  |
| **Europe** ($ million) | **600**  **[MRNA_3374538_2]**  | **103**  **[0001682852-23-000042_mrna-20230930.htm:10]** **[0001682852-23-000042_mrna-20230930.htm:36]**  | **60**  **[0001682852-23-000027_mrna-20230630.htm:10]**  | **576**  **[0001682852-23-000021_mrna-20230331.htm:9]**  | N/A | **281**  **[0001682852-24-000060_mrna-20240930.htm:29]**  | **0**  **[0001682852-24-000046_mrna-20240630.htm:11]**  | **0**  **[0001682852-24-000027_mrna-20240331.htm:25]**  |
| **Rest of World** ($ million) | **1,400**  **[MRNA_3374538_2]**  | **741**  **[0001682852-23-000042_mrna-20230930.htm:10]** **[0001682852-23-000042_mrna-20230930.htm:36]**  | **231**  **[0001682852-23-000027_mrna-20230630.htm:10]**  | **1,251**  **[0001682852-23-000021_mrna-20230331.htm:9]**  | N/A | **324**  **[0001682852-24-000060_mrna-20240930.htm:29]**  | **22**  **[0001682852-24-000046_mrna-20240630.htm:11]**  | **67**  **[0001682852-24-000027_mrna-20240331.htm:25]**  |

5864449dd1b89029a50e9cc369151e06899c2410ea73f7c7ddb6d795232679d2

Adjustments for Non-Cash Items (USD, M)

Stock-Based Compensation (USD, M)

Changes in Working Capital (USD, M)

Capital Expenditures (CapEx) (USD, M)

Proceeds from / Repayments of Debt (USD, M)

Share Repurchases (USD, M)

Dividend Payments (USD, M)

Net Change in Cash (USD, M)

8ea66af26414b58f65e6c743a20884c2ed7fa00e75a245fa3ffd4f40aafce823

Moderna, Inc. is a biotechnology company specializing in the development of medicines using messenger RNA (mRNA) technology. The company's mRNA platform is designed to instruct the body’s cells to produce proteins that offer therapeutic or preventive benefits, targeting a wide range of diseases including infectious diseases, immuno-oncology, rare diseases, and autoimmune diseases **[0001682852-24-000015_mrna-20231231.htm:176]** **[0001682852-24-000046_mrna-20240630.htm:8]**. Moderna's first commercial product is the COVID-19 vaccine, marketed as Spikevax®, which has been adapted to address emerging SARS-CoV-2 strains **[0001682852-24-000015_mrna-20231231.htm:176]** **[0001682852-24-000046_mrna-20240630.htm:8]**. The company offers vaccines for COVID-19, respiratory syncytial virus (RSV), and seasonal flu, and is advancing a pipeline of 45 development programs to diversify its product offerings **[0001682852-24-000015_mrna-20231231.htm:176]** **[0001682852-24-000046_mrna-20240630.htm:8]**.

1. **COVID-19 Vaccine (Spikevax®)** - Developed to combat COVID-19, this vaccine has been a major revenue driver and is adapted to address emerging SARS-CoV-2 strains **[0001682852-24-000015_mrna-20231231.htm:176]** **[0001682852-24-000046_mrna-20240630.htm:8]**.
2. **Respiratory Syncytial Virus (RSV) Vaccine (mRESVIA®)** - Approved in 2024, this vaccine is expected to contribute to revenue as it launches in the U.S. and other markets **[0001682852-24-000043_exhibit9912024q2pressrelea.htm:0]**.
3. **Seasonal Flu Vaccine** - Targets seasonal influenza, aiming to provide preventive benefits against flu strains.
4. **Combination Vaccine for Flu and COVID-19** - Combines protection against both flu and COVID-19, offering a comprehensive solution for respiratory illnesses.
5. **Pipeline of Development Programs** - Includes 45 development programs with 40 candidates in clinical studies, focusing on diversifying product offerings beyond COVID-19 **[0001682852-24-000015_mrna-20231231.htm:176]** **[0001682852-24-000046_mrna-20240630.htm:8]**.

019bfe048d374caff1defec1d1a55a27b2546d627403d3b29a26d5f41791e7c2

1. Given the delays in securing full contracting seasons, how do you plan to maximize sales of your approved products, such as Spikevax and mRNA-1345, especially in light of the competitive environment in the U.S. COVID-19 vaccine market?
2. Can you provide detailed insights into your reserve return assumptions for this winter season, particularly considering the $500 million-plus reserve from last winter that was adjusted down to approximately $400 million?
3. With the purchase of the Norwood campus impacting your capital expenditures, how will this acquisition affect your cash position and cost-saving initiatives, and how do you plan to reconcile this with your goal of ending 2024 with approximately $9 billion in cash and investments?
4. Considering the timing challenges with your flu-COVID combination vaccine and the decision not to use a priority review voucher, how will this impact your ability to capture market share in the 2025 flu season, and what strategies are you implementing to mitigate potential revenue gaps?
5. Given the late approval of your RSV vaccine relative to the contracting season, how confident are you in achieving significant market share next year, and what realistic expectations should investors have regarding your position in the RSV vaccine market?

6fddb1a636ebfc3834950137aa976eac1d54600e6a48f736ef036e67c08b686e

Net Product Sales

- COVID-19 Vaccine

- RSV Vaccine

Other Revenue

- Grant Revenue

- Collaboration Revenue

- Licensing and Royalty Revenue

Gross Product Sales

Product Sales Provision

Total Revenue

cba998bd15d17a1f2fcc4a51e49d1e6fa10d933aaf6671f78185351c29d4ef1e

United States

Europe

Rest of World

a210f6ebf3b6d24e9b4eb5dc9092e17e1c36b98dd00e4a39f7277dcc6c1527d1

### Q3 2024 Earnings Call
- **Issued Period**: Q3 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Net Product Sales**: $3 billion to $3.5 billion, implying Q4 sales of $0.8 billion to $1.3 billion  **[MRNA_3406475_4]** .
  2. **U.S. Q4 Product Sales**: $200 million to $500 million  **[MRNA_3406475_4]** .
  3. **International Q4 Product Sales**: $600 million to $800 million  **[MRNA_3406475_4]** .
  4. **Cost of Sales**: 40% to 45% of product sales  **[MRNA_3406475_5]** .
  5. **R&D Expenses**: $4.6 billion to $4.7 billion  **[MRNA_3406475_5]** .
  6. **SG&A Expenses**: Approximately $1.2 billion  **[MRNA_3406475_5]** .
  7. **Taxes**: Negligible  **[MRNA_3406475_6]** .
  8. **Capital Expenditures**: Approximately $1.2 billion  **[MRNA_3406475_6]** .
  9. **Cash and Investments**: Approximately $9 billion  **[MRNA_3406475_6]** .

### Q2 2024 Earnings Call
- **Issued Period**: Q2 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Net Product Sales**: $3.0 billion to $3.5 billion  **[MRNA_3395662_4]** .
  2. **Cost of Sales**: 40% to 50% of product sales  **[MRNA_3395662_4]** .
  3. **R&D Expenses**: Approximately $4.5 billion  **[MRNA_3395662_4]** .
  4. **SG&A Expenses**: Approximately $1.3 billion  **[MRNA_3395662_4]** .
  5. **Taxes**: Negligible  **[MRNA_3395662_4]** .
  6. **Capital Expenditures**: Approximately $0.9 billion  **[MRNA_3395662_4]** .
  7. **Year-End Cash Balance**: Approximately $9 billion  **[MRNA_3395662_4]** .

### Q1 2024 Earnings Call
- **Issued Period**: Q1 2024
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Net Sales**: Approximately $4 billion  **[MRNA_3382108_3]** .
  2. **Cost of Sales**: Approximately 35% of product sales  **[MRNA_3382108_3]** .
  3. **R&D Expenses**: Approximately $4.5 billion  **[MRNA_3382108_3]** .
  4. **SG&A Expenses**: Approximately $1.3 billion  **[MRNA_3382108_3]** .
  5. **Taxes**: Negligible  **[MRNA_3382108_3]** .
  6. **Capital Expenditures**: Approximately $0.9 billion  **[MRNA_3382108_3]** .
  7. **Cash and Investments**: Approximately $9 billion  **[MRNA_3382108_3]** .

### Q4 2023 Earnings Call
- **Issued Period**: Q4 2023
- **Guided Period**: FY 2024
- **Guidance**:
  1. **Net Sales**: Approximately $4 billion  **[MRNA_3374538_3]** .
  2. **Cost of Sales**: Approximately 35% of product sales  **[MRNA_3374538_3]** .
  3. **R&D Expenses**: Approximately $4.5 billion  **[MRNA_3374538_3]** .
  4. **SG&A Expenses**: Approximately $1.3 billion  **[MRNA_3374538_3]** .
  5. **Taxes**: Negligible  **[MRNA_3374538_3]** .
  6. **Capital Expenditures**: Approximately $0.9 billion  **[MRNA_3374538_3]** .
  7. **Cash Position**: Approximately $9 billion  **[MRNA_3374538_3]** .

00d5a72da44e2101865fd66406b8663a34451335b77cf6cffb3ef44291adde9d

| Name                  | Position                                      | Start Date        | Short Bio                                                                                                                                                                                                 |
|-----------------------|-----------------------------------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stéphane Bancel       | Chief Executive Officer                       | October 2011      | Stéphane Bancel has served as the CEO of Moderna since **October 2011**. Previously, he was CEO of bioMérieux SA and held roles at Eli Lilly. He holds degrees from École Centrale Paris, University of Minnesota, and Harvard Business School  **[0001308179-24-000091_lmrna2024_pre14a.htm:34]** **[0001308179-24-000208_lmrna2024_def14a.htm:34]** **[0001308179-24-000208_lmrna2024_def14a.htm:11]** **[0001308179-24-000091_lmrna2024_pre14a.htm:11]** . |
| Jerh Collins          | Chief Technical Operations and Quality Officer| October 2022      | Jerh Collins joined Moderna in **October 2022** and has been in his current role since **January 2023**. He previously worked at Novartis from 1993 to 2022  **[0001308179-24-000091_lmrna2024_pre14a.htm:34]** **[0001308179-24-000208_lmrna2024_def14a.htm:34]** .                                        |
| Kate Cronin           | Chief Brand Officer                           | July 2021         | Kate Cronin joined Moderna in **July 2021**. She oversees communications, branding, and marketing. Previously, she was Global CEO at Ogilvy Health  **[0001308179-24-000208_lmrna2024_def14a.htm:35]** **[0001308179-24-000091_lmrna2024_pre14a.htm:35]** **[0001308179-23-000184_lmrna2023_def14a.htm:34]** .                                             |
| Tracey Franklin       | Chief Human Resources Officer                 | October 2019      | Tracey Franklin joined Moderna in **October 2019**. She oversees talent and organizational strategy. Previously, she worked at Merck & Co. from 2004 to 2019  **[0001308179-24-000091_lmrna2024_pre14a.htm:35]** **[0001308179-24-000208_lmrna2024_def14a.htm:35]** **[0001308179-23-000184_lmrna2023_def14a.htm:35]** .                                    |
| Stephen Hoge, M.D.    | President                                     | January 2013      | Stephen Hoge, M.D., joined Moderna in **January 2013** and has been President since **February 2015**. He oversees R&D and early commercial efforts. Previously, he was a Partner at McKinsey & Company  **[0001308179-24-000208_lmrna2024_def14a.htm:35]** **[0001308179-24-000091_lmrna2024_pre14a.htm:35]** . |
| Shannon Thyme Klinger | Chief Legal Officer and Corporate Secretary   | June 2021         | Shannon Thyme Klinger joined Moderna in **June 2021**. She oversees legal matters and serves as President of the Moderna Charitable Foundation. Previously, she worked at Novartis  **[0001308179-24-000208_lmrna2024_def14a.htm:35]** **[0001308179-24-000091_lmrna2024_pre14a.htm:35]** **[0001308179-23-000184_lmrna2023_def14a.htm:35]** .               |
| James Mock            | Chief Financial Officer                       | September 2022    | James Mock joined Moderna in **September 2022**. He oversees financial functions. Previously, he was CFO at PerkinElmer and held various roles at General Electric  **[0001308179-24-000091_lmrna2024_pre14a.htm:36]** **[0001308179-23-000184_lmrna2023_def14a.htm:35]** .                                |

328a4e021bd7dcd005b0142b3e344dfc12d3fcff17ee931a9395a2566f1e70fd

| Program Details          | Program 1       |
|--------------------------|-----------------|
| Approval Date            | August 1, 2022  **[0001682852-24-000060_mrna-20240930.htm:44]** **[0001682852-24-000060_mrna-20240930.htm:24]**  |
| End Date/Duration        | No expiration date  **[0001682852-24-000060_mrna-20240930.htm:44]** **[0001682852-24-000060_mrna-20240930.htm:24]**  |
| Total additional amount  | **$3.0 billion**  **[0001682852-24-000060_mrna-20240930.htm:44]** **[0001682852-24-000060_mrna-20240930.htm:24]**  |
| Remaining authorization  | **$1.7 billion** as of September 30, 2024  **[0001682852-24-000060_mrna-20240930.htm:44]** **[0001682852-24-000060_mrna-20240930.htm:24]**  |
| Details                  | The program aims to return capital to shareholders, improve earnings per share, and manage capital structure. The timing and number of shares repurchased depend on various factors, including price and market conditions.  **[0001682852-23-000011_mrna-20221231.htm:229]** **[0001682852-22-000042_mrna-20220630.htm:24]** **[0001682852-24-000046_mrna-20240630.htm:41]**  |

0736beaa3a54edf36e946a6c7512d492187bc3b531ebd287f71e415a855fe547

**Quarterly guidance for Q4 2024:**
- **Net product sales**: $0.8B to $1.3B  **[MRNA_3406475_4]**  (no change from $0.8B to $1.3B  **[MRNA_3406475_5]** )  
- **U.S. Q4 product sales**: $200M to $500M  **[MRNA_3406475_4]**  (no change from $200M to $500M  **[MRNA_3406475_5]** )  
- **International Q4 product sales**: $600M to $800M  **[MRNA_3406475_4]**  (no change from $600M to $800M  **[MRNA_3406475_5]** )  

**Annual guidance for FY 2024:**
- **Net product sales**: $3B to $3.5B  **[MRNA_3406475_4]**  (no change from $3B to $3.5B  **[MRNA_3406475_5]** )  
- **Cost of sales**: 40% to 45%  **[MRNA_3406475_4]**  (no change from 40% to 45%  **[MRNA_3406475_5]** )  
- **R&D expenses**: $4.6B to $4.7B  **[MRNA_3406475_4]**  (no change from $4.6B to $4.7B  **[MRNA_3406475_5]** )  
- **SG&A expenses**: $1.2B  **[MRNA_3406475_4]**  (no change from $1.2B  **[MRNA_3406475_5]** )  
- **Capital expenditures**: $1.2B  **[MRNA_3406475_4]**  (no change from $1.2B  **[MRNA_3406475_5]** )  
- **Cash and investments**: $9B  **[MRNA_3406475_4]**  (no change from $9B  **[MRNA_3406475_5]** )  

No additional new metrics appeared in the most recent guidance.

4aa8e7115c24c59bfc356194beeba947c3f57d760f129d40bebc9837210a78e4

| Name              | Start Date | End Date | Reason for Change |
|-------------------|------------|----------|-------------------|
| Ernst & Young LLP | 2014  **[0001682852-24-000015_mrna-20231231.htm:171]**    | Present  | Current auditor   |

831bb02530460a1544ab63297ac9247d35673eb44a39bb16f4ef192f380137ae

23794d91c53ae875c8e247d72561e35d9d06ee07c70c9e0dbcc977a6d161504a

- **Moderna expects up to 10 product approvals over the next 3 years**, including key vaccines like CMV and RSV, which they believe will drive sales growth.  **[MRNA_3406475_9]**
- **They are making progress on cost-saving initiatives, expecting to decrease annual R&D expenses by $1.1 billion by 2027**, improving financial efficiency.  **[MRNA_3406475_9]**
- **Moderna plans to launch a combination flu-COVID vaccine in 2026**, aiming to protect high-risk individuals and seeing significant potential in this market.  **[MRNA_3406475_21]**

eeb304ab929b60da3121676762eaece4c0a3a8480244cdc1a2206987565299cb

fb569a31e412a574fc1de8ec3552ee56531c3820e534b18a9fce84e1301a7ae1

0baa32afc2d0d7d5e5128ecf4ec48ba9dd3de1848359e47b5e23f53324dccdb8

1967180e4837622140e8d548955ce676de7e11beec7ee10080562d64fd33da9b

- **Uncertainty in revenue projections due to lack of specific guidance on RSV vaccine sales and competition from existing approved vaccines**  **[MRNA_3382108_9]** **[MRNA_3382108_18]** . The company stated, "we haven't guided any specific guidance or number for RSV" and acknowledged that competitors "have a head start, timing-wise"  **[MRNA_3382108_9]** **[MRNA_3382108_18]** .
- **Potential delays in regulatory approvals for key products like the flu vaccine, which may impact revenue growth projections**.  **[MRNA_3382108_11]**  The company mentioned that they are "engaged right now...with regulators on the process for submission of the flu vaccine" and that "those discussions are ongoing," indicating potential uncertainty in approval timelines.  **[MRNA_3382108_11]**
- **Oncology programs face significant hurdles before commercialization, including lengthy confirmatory studies and manufacturing scale-up, delaying potential returns on investment**  **[MRNA_3382108_20]** **[MRNA_3382108_9]** . The company admitted that for the INT (Individualized Neoantigen Therapy) program, they have "not consulted with the agency on that yet" and that "it could be several years" before the confirmatory study matures.  **[MRNA_3382108_9]**  Additionally, they are "not prepared to disclose" the actual R&D cost for the cancer program.  **[MRNA_3382108_20]**

3a1fa880fb5fe1f2dcf042a1dbe0eaf6736862403a79453884ddd8dd2e9a6eb6

- **Moderna expects to have $9 billion in cash next year** and plans to return to growth in 2025 by launching new products like the RSV vaccine, indicating a strong financial position and future growth prospects.  **[MRNA_3395662_12]**
- **Moderna maintained approximately 50% market share in the U.S. COVID vaccine market last year** and is confident in the overall performance of its U.S. business despite increased competition, demonstrating strong market presence.  **[MRNA_3395662_15]**
- Moderna is advancing **mRNA therapeutics for pulmonary diseases**, including a **cystic fibrosis program partnered with Vertex**, highlighting potential future growth opportunities in new therapeutic areas.  **[MRNA_3395662_17]**

4787b144037746d3d910606846c531616e316d2fe667c448d8bcd3c63b56ebc0

- **Moderna's RSV vaccine offers ease of use with a prefilled syringe presentation, providing significant advantages over competitors and reducing burden on pharmacies facing labor shortages.**  **[MRNA_3374538_8]**
- **The Individualized Neoantigen Therapy (INT) program is progressing well, with rapid enrollment in Phase III trials and manufacturing scale-up, positioning Moderna for potential accelerated approval in melanoma.**  **[MRNA_3374538_15]** **[MRNA_3374538_4]** **[MRNA_3374538_16]**
- **Potential upside in European COVID-19 vaccine sales due to a new EU tender allowing Moderna to participate, and efforts to increase vaccination rates in the U.S., could boost revenues beyond 2024 guidance.**  **[MRNA_3374538_13]**

c88c6ac4bde63701ae80491600b9cb46db061ca46bc2d7372e227cb706f319aa

1. **RSV Approval and ACIP Recommendation**  
   **Q:** Is the RSV PDUFA date still May 12, and what's the expected ACIP recommendation?  
   **A:** We're working towards the **same PDUFA date** with **no changes**.  **[MRNA_3382108_17]**  We hope for a **parity ACIP recommendation** based on our data, including durability and immunogenicity, but the final decision rests with ACIP.  **[MRNA_3382108_11]** 

2. **INT Phase III and Accelerated Approval**  
   **Q:** How critical is INT Phase III progress before FDA engagement, and is Merck on board?  
   **A:** Substantial enrollment in the **confirmatory study** is crucial for **accelerated approval**.  **[MRNA_3382108_9]**  We're making great progress but haven't consulted FDA yet. While we defer to regulators, we believe both we and Merck would want to make the product available if supported.  **[MRNA_3382108_16]** 

3. **Flu Vaccine Filing and 1083 Data**  
   **Q:** When will you file the flu vaccine, and how does 1083 data affect it?  
   **A:** We expect to **file the flu product this year**, pending considerations and data from our flu-COVID combo vaccine, **mRNA-1083**.  **[MRNA_3382108_11]**  The **1083 data is expected imminently** and will inform our regulatory strategy and submission sequencing.  **[MRNA_3382108_18]** 

4. **CMV Data Timing and Vaccination Strategy**  
   **Q:** When is CMV interim data expected, and will you vaccinate seropositives?  
   **A:** We expect the **CMV readout this year** with **no delays**.  **[MRNA_3382108_19]**  While transmission risk is highest in seronegatives, seropositives can also benefit due to reactivation; thus, we see potential in vaccinating both groups.  **[MRNA_3382108_18]** 

5. **INT Manufacturing Capacity**  
   **Q:** Update on INT manufacturing capacity and expansion plans?  
   **A:** We've sized our plant to meet the **melanoma market** needs and future indications.  **[MRNA_3382108_18]**  We acquired a facility and are building **modular capacity** that can be quickly expanded as needed.  **[MRNA_3382108_18]** 

6. **RSV Revenue and Contract Strategy**  
   **Q:** How much RSV revenue is in guidance, and how will you compete?  
   **A:** We haven't provided specific **RSV revenue guidance**.  **[MRNA_3382108_9]**  We can't contract until FDA approval but are actively engaging pharmacies about our product's efficacy, safety, and **PFS** (prefilled syringe) benefits.  **[MRNA_3382108_8]** 

7. **IP Litigation Impact**  
   **Q:** Thoughts on recent IP ruling and impact on COVID sales?  
   **A:** We believe our COVID-19 vaccine technology doesn't infringe on asserted patents.  **[MRNA_3382108_17]**  We're **confident in our position** and look forward to presenting our case.  **[MRNA_3382108_17]** 

8. **Refrigerator Stable Vaccines**  
   **Q:** Will your flu and combo vaccines be refrigerator stable?  
   **A:** All our respiratory vaccines, including the flu-COVID combo **mRNA-1083**, are being developed as **refrigerator stable prefilled syringes**, facilitating global delivery.  **[MRNA_3382108_15]** 

9. **EU COVID Vaccine Tender**  
   **Q:** Under what scenario can you get 36 million EU doses, and pricing?  
   **A:** The EU tender for up to **36 million doses** depends on participating countries; we'll know after the process.  **[MRNA_3382108_16]**  We won't disclose pricing due to competitive reasons.  **[MRNA_3382108_16]** 

10. **Cancer Program Costs and Indications**  
    **Q:** Can you disclose cancer program R&D costs and indications pursued?  
    **A:** We're not disclosing **R&D costs** at this time.  **[MRNA_3382108_20]**  We will continue adding more indications in partnership with **Merck** but can't provide specifics now.  **[MRNA_3382108_20]** 

43d1eb272f471d0ed820dc9004e49139c860167346a969d6eedd8434140e420b

1. **2024 Revenue Guidance Upside/Downside**  
   **Q:** What could be the upside or downside for your 2024 revenue guidance of $4 billion?  
   **A:** Stéphane Bancel highlighted that upside could come from participating in the new COVID vaccine tender in Europe, increasing vaccination rates in the U.S., and the RSV vaccine launch and market share gains. Downside risks include lower vaccination rates and potential delays in the RSV launch due to regulatory approvals.  **[MRNA_3374538_9]** 

2. **Melanoma Vaccine Accelerated Approval**  
   **Q:** What's your latest thinking on accelerated approval for the melanoma vaccine?  
   **A:** Stephen Hoge expressed excitement about the data and mentioned they are discussing accelerated approval with regulators. Key criteria include demonstrating durability, substantial enrollment in the confirmatory Phase III study, and establishing a commercial manufacturing facility. Recent data showed durability, and they're making progress on the other criteria.  **[MRNA_3374538_12]** 

3. **CMV Vaccine Efficacy Expectations**  
   **Q:** What vaccine efficacy would be clinically meaningful for the CMV Phase III trial?  
   **A:** Stephen Hoge stated that a vaccine efficacy of around **50%** would be significant, as no current vaccine prevents CMV infection. Anything above that would be incredibly exciting. They're enrolling both seropositive and seronegative participants, aiming to launch the product for both groups without needing a diagnostic test.  **[MRNA_3374538_10]** 

4. **CMV Trial Readout Timelines**  
   **Q:** When can we expect a readout from the CMV trial, and what's the statistical plan?  
   **A:** Stephen Hoge explained they are fully enrolled and accruing cases, needing approximately **80 cases** for the first interim analysis. They expect to have enough cases this year, anticipating a readout from the interim analysis, possibly even the final analysis for efficacy in **2024**.  **[MRNA_3374538_11]** 

5. **RSV Vaccine Market Dynamics**  
   **Q:** How will your RSV vaccine compete in the market, given existing competitors?  
   **A:** Stéphane Bancel is optimistic about their RSV vaccine's potential, emphasizing the convenience of a prefilled syringe and the importance of simplifying pharmacy workflows amid labor shortages. He believes their product will be a meaningful tool for customers.  **[MRNA_3374538_8]**  Additionally, Stephen Hoge expects public health officials to view their product similarly to competitors, leading to consistent recommendations.  **[MRNA_3374538_12]** 

6. **Manufacturing Scale-Up for Melanoma Vaccine**  
   **Q:** What's the status of manufacturing scale-up for the melanoma vaccine, and when will the facility be ready?  
   **A:** Stephen Hoge mentioned they've made significant progress in scaling up manufacturing for clinical supply and are rapidly enrolling patients in Phase III studies. The Marlborough facility is being built as a purpose-built commercial site for the individualized neoantigen therapy, with the goal to establish it for clinical supply this year.  **[MRNA_3374538_16]** 

7. **Flu Vaccine Discussions with FDA**  
   **Q:** Can you provide an update on discussions with FDA for your seasonal flu vaccine?  
   **A:** Stephen Hoge stated they are in ongoing conversations with the FDA and global regulators about the data package required for submission of their mRNA-1010 influenza vaccine. They are discussing the total submission data package and duration of follow-up in studies.  **[MRNA_3374538_15]** 

8. **RSV Vaccine in Pediatrics**  
   **Q:** What's the status of evaluating the RSV vaccine in the pediatric population?  
   **A:** Stéphane Bancel said they haven't started the pediatric Phase III study yet. The vaccine is in Phase I/II trials, and they're waiting for data before moving into the pediatric setting.  **[MRNA_3374538_13]** 

9. **Correlate of Protection for RSV**  
   **Q:** When will you have a correlate of protection for RSV, and how important is this for competition?  
   **A:** Stephen Hoge believes they've identified a strong candidate in neutralizing antibodies as a correlate of protection. They plan to publish data and include it in regulatory submissions this year. Once established, it will guide public health recommendations on revaccination and boosting, impacting competitive dynamics.  **[MRNA_3374538_14]** 

10. **Australia's Impact on RSV Launch**  
    **Q:** How integral will Australia be for your RSV launch and COVID vaccination trends?  
    **A:** Stéphane Bancel noted that Australia is different commercially compared to the U.S., more akin to European markets. While they have a strong presence in Australia and are building a plant in Melbourne, he doesn't think events there will directly correlate with U.S. market outcomes for RSV or COVID vaccines.  **[MRNA_3374538_17]** 

f14f7db9c7fd8ebda46cf305bf871671536d801931bf92ae8abc2b05db11c215

1. **COVID Vaccine Sales Outlook**  
   **Q:** Why is Q4 COVID vaccine revenue declining significantly?  
   **A:** The company anticipates a **60% to 80% decline in Q4 COVID vaccine sales** compared to Q3 due to earlier vaccinations and shifting dynamics across retail, IDN, and government channels. They observed an early start to the season with vaccinations peaking and now declining. Efforts are underway to boost vaccinations ahead of Thanksgiving and Christmas, but the overall impact remains uncertain.  **[MRNA_3406475_15]** 

2. **RSV Vaccine Market Potential**  
   **Q:** What is the outlook for the RSV vaccine market?  
   **A:** The RSV vaccine market has been **much lower than anticipated**, impacted by new CDC guidelines released in June. The company expects a potential uptick in Q1 as inventory levels adjust and believes contracting in a full season next year will improve their position. They remain confident in the long-term importance of RSV vaccines, particularly outside the U.S., where approvals are progressing.  **[MRNA_3406475_14]** **[MRNA_3406475_19]** 

3. **Flu-COVID Combo Vaccine Approval Timing**  
   **Q:** When will the flu-COVID combo vaccine be available?  
   **A:** Due to timing considerations, the company will not use a priority review voucher for the flu-COVID combo vaccine, as it would not align with the contracting season. They plan to submit for approval this year but do not expect the product to impact the **2025 flu season**. They anticipate potential approval and market impact in **2026**, aiming to protect high-risk populations with a combination vaccine.  **[MRNA_3406475_13]** **[MRNA_3406475_14]** **[MRNA_3406475_21]** 

4. **Individualized Neoantigen Therapy (INT) Progress**  
   **Q:** What is the status of the INT program and manufacturing facility?  
   **A:** The INT program is accelerating with a new Phase III trial in non-small cell lung cancer. The manufacturing facility in Massachusetts is **on track for completion by year-end**, and once operational, clinical work will transition there. Bridging studies will be conducted, and manufacturing capacity is not a primary constraint for expanding the INT program into additional indications.  **[MRNA_3406475_16]** **[MRNA_3406475_20]** 

5. **Ex-U.S. Revenue and Contracts**  
   **Q:** How significant are ex-U.S. COVID revenue contracts?  
   **A:** While specifics are undisclosed, the company has established contracts with countries like the **UK, Canada, Australia, and Brazil**. Ex-U.S. revenues are expected to **decline in 2025** but then **uptick in 2026** as new products are added and minimum purchase commitments grow over time.  **[MRNA_3406475_11]** **[MRNA_3406475_12]** 

6. **Cytomegalovirus (CMV) Vaccine Trial Updates**  
   **Q:** When can we expect CMV vaccine trial results?  
   **A:** The CMV vaccine trial is progressing steadily with case accrual. If the **Data Safety Monitoring Board (DSMB)** recommends unblinding at the interim analysis due to meeting efficacy criteria, results will be shared promptly. Otherwise, the final analysis could happen quickly, and communication will depend on the timing and conditions.  **[MRNA_3406475_11]** **[MRNA_3406475_12]** 

7. **Legal Liabilities and Litigation**  
   **Q:** What's the company's stance on the GSK lawsuit?  
   **A:** The company will not comment on the merits of GSK's case but notes that such lawsuits are **not uncommon** during market formation around new technology. They are prepared to defend themselves and look forward to presenting their case at trial as scheduled.  **[MRNA_3406475_21]** 

8. **Orphan Disease Pipeline Developments**  
   **Q:** What's the path forward for the orphan disease programs?  
   **A:** Pivotal trials for MMA and PA are moving forward, with plans to use a **biomarker for approval** in MMA, potentially accelerating timelines. The goal is to launch these products in the **2026+ timeframe**, with the possibility of earlier approval if patient accrual is rapid.  **[MRNA_3406475_18]** 

9. **Financial Impacts: Reserve Returns**  
   **Q:** What are the details on reserve returns from last season?  
   **A:** The company released about **$140 million** in the quarter by reducing reserves, lowering the prior estimate from over **$500 million to approximately $400 million**. They are applying learnings to forecast the anticipated product returns reserve for this season and will monitor vaccination rates to adjust projections.  **[MRNA_3406475_13]** 

10. **Impact of Election Results on Vaccine Use**  
    **Q:** Will the change in administration affect vaccine use in the U.S.?  
    **A:** The company believes their mission aligns with public health goals and will continue to collaborate with government leaders regardless of administrative changes. They aim to reassure confidence and focus on delivering innovative medicines to improve health outcomes.  **[MRNA_3406475_17]** 

70a926ded906a1362cb460c93580a7ced924bd7e0b91600809185aed9b6ee798

- **Moderna has lowered its 2024 revenue outlook to $3.0-$3.5 billion due to very low expected sales from EU member states and potential revenue deferrals into 2025**, indicating demand challenges for its COVID-19 vaccine in key markets.  **[MRNA_3395662_11]**
- **Increased competitive pressures are leading to a slower-than-anticipated ramp of their RSV vaccine**, with the company admitting that **"this year is not turning out as we expected"** and acknowledging lower 2024 market share due to being third to market and existing competitor contracts.  **[MRNA_3395662_13]**
- **The company expects a $4 billion decrease in cash in 2024**, from **$13 billion** at the start of the year to **$9 billion** by year-end, highlighting significant cash burn and raising concerns about future cash flow and the ability to fund operations without affecting R&D and SG&A expenses.  **[MRNA_3395662_12]**

06db8a2738d0d58b0deec8facaaeecbf4269739a0ca78fa4f89d4dfe21a3a210

- **Delays in Key Product Launches May Impact Revenue Growth**: The company does not expect its combination flu COVID vaccine to launch in 2025, pushing potential revenue from this product to **2026 or later**. They have not included any revenue from certain submissions in their 2025 guidance.  **[MRNA_3406475_12]** ,  **[MRNA_3406475_21]**
- **Expected Decline in Rest of World Revenues in 2025**: Moderna anticipates a decrease in ex-U.S. revenues in **2025** before growth resumes in 2026, potentially leading to an overall revenue decline next year.  **[MRNA_3406475_11]** ,  **[MRNA_3406475_10]**
- **Legal Risks Due to Ongoing Litigation**: The company is facing a lawsuit from GSK over COVID-19 vaccine patents, which could have financial implications if not resolved favorably.  **[MRNA_3406475_21]**

d0c792fb9b2483fd14b9c4829bfa6d4ab3004932a0e29f06f2e1b28f095454c5

1. **Cash Balance Guidance**  
   **Q:** How can you maintain year-end cash guidance despite lower revenue?  
   **A:** Management remains confident in ending the year with **$9 billion** in cash  **[MRNA_3395662_10]** , due to factors like revenue deferrals (some cash already collected), effective working capital management, and having a cushion entering the year.  **[MRNA_3395662_10]** 

2. **Guidance Cut Breakdown**  
   **Q:** How much of the guidance cut is from COVID vs. RSV?  
   **A:** The guidance reduction is equally driven by three factors: deferrals (all related to COVID), EU issues (COVID), and competitive pressures in respiratory vaccines, which is split between COVID and RSV.  **[MRNA_3395662_11]** 

3. **OpEx and Cash Outlook**  
   **Q:** Will cash guidance change, and is flexing OpEx a priority?  
   **A:** Despite the cash decrease from **$13 billion to $9 billion** this year  **[MRNA_3395662_12]** , management expects cash to remain **$6–$7 billion** by end of 2025.  **[MRNA_3395662_12]**  They are focused on OpEx but do not plan significant changes.  **[MRNA_3395662_12]** 

4. **Competitive Pressures**  
   **Q:** How are competitive pressures affecting RSV and COVID outlook?  
   **A:** There's increased competition due to bundling by larger competitors, aggressive pricing, and marketing activities.  **[MRNA_3395662_10]**  For RSV, being third to market and only participating in the second half impacts share.  **[MRNA_3395662_12]**  They anticipate better market share in 2025.  **[MRNA_3395662_20]** 

5. **RSV Market Potential**  
   **Q:** How does ACIP's one-and-done RSV recommendation affect market potential?  
   **A:** Management wasn't surprised  **[MRNA_3395662_16]** ; they believe revaccination may be needed as protection wanes over time.  **[MRNA_3395662_16]**  They expect public health recommendations to evolve, potentially supporting booster doses in the future.  **[MRNA_3395662_16]** 

6. **RSV Market Size Expectations**  
   **Q:** Is the RSV market smaller than prior estimates?  
   **A:** While on paper the market seems smaller, clearer guidelines may improve uptake.  **[MRNA_3395662_21]**  They believe the patient population is still sizable, and vaccination rates may be similar or slightly higher than last year.  **[MRNA_3395662_21]** 

7. **Cancer Vaccine Progress**  
   **Q:** What's the status of the Phase III melanoma vaccine trial and manufacturing?  
   **A:** Enrollment is progressing briskly; they expect to conclude soon but haven't provided a specific date.  **[MRNA_3395662_19]**  Manufacturing has made great progress, with the Marlboro facility able to produce at commercially relevant volumes.  **[MRNA_3395662_19]** 

8. **CMV Vaccine Timing**  
   **Q:** When can we expect interim results from the Phase III CMV study?  
   **A:** Interim analysis could happen this year, including the required median safety follow-up.  **[MRNA_3395662_14]**  There's no change to prior guidance.  **[MRNA_3395662_14]** 

9. **Orphan Disease Programs**  
   **Q:** What's the regulatory path for MMA and PA programs?  
   **A:** Early conversations are ongoing.  **[MRNA_3395662_18]**  In MMA, they see promising biomarker movement and are working on validating it with regulators.  **[MRNA_3395662_18]**  In PA, lacking a clear biomarker, they're focusing on clinical event rates and discussing approaches with FDA.  **[MRNA_3395662_18]** 

10. **COVID Vaccination Impact**  
    **Q:** Will the summer COVID wave affect fall vaccinations?  
    **A:** The summer wave doesn't change their outlook; they expect vaccination rates to be similar to last year.  **[MRNA_3395662_22]**  Protection for the higher-risk winter season remains crucial.  **[MRNA_3395662_22]** 

11. **Pulmonary Delivery Indications**  
    **Q:** Are there additional indications for pulmonary delivery being explored?  
    **A:** They acknowledge many pulmonary diseases could benefit but are in early research stages.  **[MRNA_3395662_17]**  Current partnership with Vertex is limited to cystic fibrosis.  **[MRNA_3395662_17]** 

6cd45c5067479a717932491aa6abeeba68fc2a261265564862af4d0ac4cce42f

- **Moderna is expanding their oncology pipeline through their partnership with Merck, with multiple new adjuvant cancer indications for their Individualized Neoantigen Therapy (INT), based on positive Phase II melanoma results, demonstrating strong potential in their cancer vaccine platform.**  **[MRNA_3382108_20]** **[MRNA_3382108_2]** **[MRNA_3382108_8]**
- **Moderna is progressing towards regulatory approval of their RSV vaccine, confirming that the PDUFA date remains on track, potentially adding significant revenue and expanding their respiratory vaccine portfolio.**  **[MRNA_3382108_15]** **[MRNA_3382108_8]**
- **Moderna is actively participating in an EU tender process for up to 36 million doses of their COVID vaccine annually, indicating continued demand and potential significant revenue in Europe.**  **[MRNA_3382108_14]**

82d7c4669d9014f7055011d439d1b11a1abf2e4546a19f04996829d443c16254

- **Declining COVID-19 vaccine sales and lower vaccination rates are projected to reduce 2024 revenues.** Moderna expects net sales of approximately $4 billion in 2024, down from $6.7 billion in 2023. The company acknowledges that vaccination rates in the U.S. were lower than last year, which could be a downside risk to sales.  **[MRNA_3374538_3]** **[MRNA_3374538_9]**
- **Potential delays and uncertainties in regulatory approvals and product launches for RSV and flu vaccines amid strong competition.** Contracting for the RSV vaccine cannot start until approval is received, and timing of RSV launch could be delayed due to regulatory approvals. There is also competition from Pfizer and GSK, with similar products already in the market.  **[MRNA_3374538_6]** **[MRNA_3374538_15]** **[MRNA_3374538_9]** **[MRNA_3374538_12]**
- **Significant net loss and cash burn raise financial concerns.** Moderna reported a net loss of $4.7 billion in 2023 compared to income of $8.4 billion in 2022. The company expects to end 2024 with approximately $9 billion in cash, down from $13.3 billion at the end of 2023, indicating continued cash burn. Additionally, they established a valuation allowance against deferred tax assets due to projected losses.  **[MRNA_3374538_2]** **[MRNA_3374538_3]**

ef68832498381e2a492346d41e8dbf1a5ac020c9535447c76d0cf62070da1d98

Moderna Inc (MRNA)

Financials