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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 . Moderna's first commercial product is the COVID-19 vaccine, marketed as Spikevax®, which has been adapted to address emerging SARS-CoV-2 strains . 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 .
- 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 .
- 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 .
- Seasonal Flu Vaccine - Targets seasonal influenza, aiming to provide preventive benefits against flu strains.
- Combination Vaccine for Flu and COVID-19 - Combines protection against both flu and COVID-19, offering a comprehensive solution for respiratory illnesses.
- Pipeline of Development Programs - Includes 45 development programs with 40 candidates in clinical studies, focusing on diversifying product offerings beyond COVID-19 .
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
James Mock Executive | Chief Financial Officer | None | James Mock joined Moderna as CFO in September 2022, overseeing financial planning, investor relations, and other financial functions. | |
Shannon Thyme Klinger Executive | Chief Legal Officer and Corporate Secretary | President of the Moderna Charitable Foundation | Shannon Klinger joined Moderna in June 2021, overseeing legal matters, ESG strategy, and global security. | |
Stéphane Bancel Executive | Chief Executive Officer | Venture Partner at Flagship Pioneering | Stéphane Bancel has been the CEO of Moderna since October 2011, leading the company through significant growth and innovation, including its contributions to public health during the COVID-19 pandemic. | View Report → |
Stephen Hoge Executive | President | None | Stephen Hoge joined Moderna in January 2013 and has served as President since February 2015, overseeing R&D and commercial strategy. | |
Abbas Hussain Board | Director | Chairman of Asceneuron SA; Director for Mallinckrodt Pharmaceuticals; Director for Alfasigma SpA; Advisor to 4Bio Capital | Abbas Hussain joined Moderna's Board in October 2024, bringing over 35 years of leadership experience in healthcare. | |
David Rubenstein Board | Director | Co-Founder and Co-Chairman of The Carlyle Group; Chairman of various organizations including the Council on Foreign Relations and National Gallery of Art | David Rubenstein joined Moderna's Board in August 2024, leveraging his extensive experience in investing and global policy. | |
Elizabeth Tallett Board | Director | Director at Elevance Health, Inc.; Director at Qiagen, Inc.; Chair of the Board of Trustees at Solebury School | Elizabeth Tallett has been a director since 2020, providing strategic insight based on her extensive experience in the pharmaceutical industry. | |
Noubar Afeyan Board | Chairman of the Board | Founder, Senior Managing Partner, and CEO of Flagship Pioneering; Member of MIT Corporation | Co-founder of Moderna, Noubar Afeyan has been Chairman since 2012, playing a pivotal role in shaping the company's strategic direction and growth. | |
Paul Sagan Board | Director | Catalyst Advisor at General Catalyst | Paul Sagan has been a director at Moderna since 2018, bringing expertise in finance, accounting, and digital technologies. |
- 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?
- 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?
- 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?
- 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?
- 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?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Our COVID-19 vaccine largely competes against their COVID-19 vaccine, which is also based on mRNA technology. | |
We also compete against other approved or authorized products, including their COVID-19 vaccine. | |
Some competitors have developed COVID-19 treatments, including their antiviral pill, and the existence of such treatments may reduce demand for vaccines. | |
Our RSV vaccine, which we expect to launch in 2024, will face competition from existing RSV vaccines, including those produced by them. | |
There are additional companies working on mRNA medicines, some of which have reached commercialization. These companies include them. | |
There are additional companies working on mRNA medicines, some of which have reached commercialization. These companies include them. | |
There are additional companies working on mRNA medicines, some of which have reached commercialization. These companies include them. | |
There are additional companies working on mRNA medicines, some of which have reached commercialization. These companies include them. |
| Customer | Relationship | Segment | Details |
|---|---|---|---|
United Kingdom Health Security Agency | Key government agency for vaccine procurement | All | 16% of revenue in 2024 ; 65% of accounts receivable as of Dec 31, 2024 |
FFF Enterprises | Distributor/wholesaler for Moderna’s products | All | 13% of revenue in 2024 ; 39% of accounts receivable in 2023 |
Taiwan Food and Drug Administration | Regulatory agency involved in vaccine procurement | All | 10% of accounts receivable in 2024 |
European Commission | Intergovernmental body purchasing vaccines | All | 28% of revenue in 2022 |
U.S. Government (excluding BARDA) | Government agency purchasing Moderna’s vaccines | All | 23% of revenue in 2022 |
Takeda Pharmaceutical Company | Partner/distributor for Japanese market | All | 10% of revenue in 2022 |
Ministry of Health, Labor, and Welfare Japan | Government ministry responsible for vaccine procurement | All | 21% of revenue in 2023 |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
OriCiro Genomics K.K. | 2023 |
Recent press releases and 8-K filings for MRNA.
- The pivotal adjuvant melanoma trial for INT individualized neoantigen therapy is fully enrolled, showing a 49% reduction in risk of recurrence or death in Phase II; data expected in 2026.
- Moderna is advancing four oncology modalities—individualized neoantigen, off-the-shelf cancer antigen, T‑cell engagers, and in vivo cell therapies—with Intismeran autogene (mRNA-4157) in Phase 3 trials for adjuvant melanoma and renal cell carcinoma, plus ongoing NSCLC studies.
- The off-the-shelf antigen therapy mRNA-4359, encoding PD‑L1 and IDO, has moved into Phase II expansion for high PD‑L1 SCLC and melanoma, targeting potential availability by 2028.
- Advancements in T cell engager and in vivo cell therapy platforms include multiplexed engagers, with lead candidate mRNA-4203 under an IND open in partnership with Immatics, alongside novel CAR‑T/CAR‑M approaches addressing solid tumor heterogeneity.
- In the respiratory franchise, mRNA-1283 (M NEXSPike) COVID vaccine is approved for ≥65 and high‑risk 12–64 year‑olds, an RSV vaccine for high‑risk 18–49 adults, and a flu/COVID combo filing is planned after a standalone flu Phase III readout this summer.
- Financially, 2025 revenue guidance is set at $1.5–2.5 billion, with Q1 showing a 20% reduction in SG&A and R&D costs; full‑year cash costs are targeted at $5.5B for 2025 and $4.7B for 2026.
- Moderna outlines strategic focus on driving top-line growth by launching ~10 new products and optimizing costs through enhanced manufacturing, R&D investments, and supplier negotiations .
- Cost reduction initiatives aim to lower cash costs from $6.3 billion to $4.2 billion by 2027, bolstering capital efficiency amid a cash reserve exceeding $8.5 billion .
- The company is pursuing external partnerships to fund late-stage vaccine trials targeting latent viruses (EBV, HSV, VZV), pausing internal spending and utilizing existing capacity .
- Pipeline updates feature approved respiratory vaccines with upcoming data for key products such as the COVID booster, flu combo, and CMV, targeting launches for 2026–2027 .
- US and international strategies include normalizing US sales near $1.5 billion and expanding manufacturing capabilities with new factories in Canada, the UK, and Australia by full-year 2026 .
- In Q1 2024, Moderna narrowed its net loss to $1 billion (loss per share $2.52), reflecting key operational improvements .
- Analyst price targets vary widely, with an average of $46.85 implying >70% upside, though some estimates suggest fair value as low as $20.40 .
- Guidance Clarity: Moderna reaffirmed its revenue and cost guidance for 2025 and emphasized a clearer regulatory path for its COVID vaccination strategy, aiming to achieve business predictability.
- COVID Vaccine Progress: The company reported recent approval of its Nexpike COVID vaccine—with a label targeting individuals 65+ and younger at-risk patients—and discussed plans for upcoming filings for a combination COVID-flu product based on positive efficacy data.
- Pipeline Developments: Moderna is advancing multiple placebo-controlled studies including those for norovirus and CMV, while awaiting robust final analyses from its event-driven trials.
- Strategic Portfolio Shift and Cost Reductions: The firm is reallocating resources from additional respiratory vaccines to new cancer immunotherapy programs, supported by consistent cost reductions (around 20% year-over-year) to optimize cash usage.
- The FDA approved Moderna’s next-gen mNexspike (mRNA-1283) for adults 65+ and ages 12–64 with underlying risk factors, limiting its use to high-risk groups.
- A phase 3 trial (11,400 participants) showed a 9.3% higher relative efficacy at a 10 µg dose versus a 50 µg dose of Spikevax, including 13.5% higher efficacy in those 65+, with identical safety profiles.
- Moderna will offer both mNexspike and Spikevax for the upcoming respiratory virus season.
- Following the FDA decision, Moderna’s stock rose 3.2% to $142.50, while Pfizer’s gained 2.1%, reflecting positive analyst sentiment.
- Diversification Strategy: Moderna is focusing on stabilizing its respiratory vaccine franchise through COVID and RSV products, including a reported 20% cost reduction in Q1 2025 compared to Q1 2024 and a roadmap to lower cash cost targets by 2027.
- Regulatory & Market Outlook: The company noted recent FDA guidance emphasizing high-risk populations for COVID boosters, which could create a more favorable market environment for new clinical initiatives.
- Flu Combo Filing Update: Moderna is adjusting its flu combo filing strategy to include efficacy data, with a Phase III readout expected this summer and potential launch timelines in 2026-2027, though timing remains variable.
- Oncology Pipeline Developments: The call highlighted progress in the oncology portfolio, including derisked Phase III melanoma trial results that show improved outcomes when combined with checkpoint inhibitors, supporting future growth in cancer therapeutics.
- Financial Performance: Moderna reported Q1 2025 revenue of $0.1B, GAAP net loss of $(1.0B), and GAAP EPS of $(2.52) .
- Liquidity: The company ended the quarter with $8.4B in cash and investments, underscoring its strong financial position .
- Cost Efficiency: Achieved a 19% decrease in cost of sales, with further GAAP operating cost reductions of $1.4–$1.7B by 2027 and a targeted 2027 cash cost of approximately $4.2B to support cash breakeven by 2028 .
- Guidance: Maintained full-year 2025 revenue guidance of $1.5–$2.5B .
- Pipeline Progress: Advanced regulatory filings for next-generation COVID and RSV vaccines, with upcoming milestones for a flu/COVID combination vaccine facing extended review and continued progress in oncology and respiratory programs .
- Product Revenues: Key revenues included Spikevax sales of $84M (US: $29M, International: $55M) and RSV vaccine mRESVIA sales of $2M .
- Pipeline Update: Moderna detailed its robust clinical development in oncology, highlighting its INT program with three Phase III studies in melanoma and NSCLC and additional Phase II studies in renal and bladder cancer, while comparing its approach favorably against competitors like BioNTech.
- Rare Disease and Financial Outlook: The call reviewed progress in rare disease programs—PA and MMA—with pivotal trial data expected in 2026 and provided insight into the 2025 revenue guidance of $1.5–$2.5 billion, emphasizing efforts to lower the cash cost structure.