Moderna Reports First Quarter 2025 Financial Results and Provides Business Updates
- Significant cost reduction initiative targeting $1.4-1.7 billion in operating cost savings by 2027
- Strong cash position of $8.4 billion as of March 31, 2025
- Multiple late-stage pipeline candidates advancing with 10 products progressing toward approval
- 19% reduction in R&D expenses and 23% reduction in SG&A expenses showing effective cost management
- Q1 2025 revenue declined to $108 million from $167 million in Q1 2024
- Reported net loss of $(1.0) billion and negative EPS of $(2.52)
- Cost of sales as percentage of net product sales increased to 104% from 58% year-over-year
- Cash position decreased from $9.5 billion to $8.4 billion during the quarter
Insights
Moderna faces continued losses but maintains 2025 guidance while implementing significant cost reductions to extend runway.
Moderna's Q1 2025 results reveal the stark reality of its post-pandemic transition with revenue plummeting to $108 million (down 35% from $167 million in Q1 2024). The net loss of $971 million ($2.52 per share) shows marginal improvement from the $1.2 billion loss in Q1 2024, but remains concerning given the scale of cash consumption.
The company's cost management efforts are beginning to materialize with R&D expenses down 19% to $856 million and SG&A costs reduced by 23% to $212 million. More importantly, management has outlined plans to slash operating costs by $1.4-$1.7 billion by 2027 – an essential move given the current financial trajectory.
Cash position has deteriorated to $8.4 billion from $9.5 billion at year-end 2024, with projections indicating a further decline to approximately $6 billion by year-end 2025. This implies a burn rate of roughly $2.4 billion for the remaining nine months of 2025.
The cost of sales at 104% of product revenue is particularly troubling, reflecting significant production inefficiencies in the current low-volume environment. With only $84 million in Spikevax sales and a mere $2 million from RSV vaccine, Moderna desperately needs new product approvals to reverse its commercial fortunes.
Despite these challenges, management has maintained its 2025 revenue guidance of $1.5-$2.5 billion, citing the seasonal nature of its respiratory vaccine business with demand concentrated in the second half of the year. The financial framework projects only $0.2 billion revenue in the first half, placing enormous pressure on H2 performance to meet annual targets.
Moderna's pipeline advances with key regulatory decisions approaching, balancing current financial struggles with future growth potential.
Moderna is navigating a critical transition period with its diversified pipeline approaching several inflection points. Most immediately, the company faces two significant FDA decisions: their next-generation COVID-19 vaccine (mRNA-1283) with PDUFA date May 31, 2025, and their RSV vaccine for high-risk adults with PDUFA date June 12, 2025. These represent near-term commercial opportunities essential for revenue growth.
The pipeline prioritization strategy has shifted resources toward oncology while maintaining momentum in key vaccine programs. However, the flu/COVID combination vaccine for older adults now faces delayed approval to 2026 following FDA requirements for Phase 3 efficacy data – a setback for the combination vaccine strategy.
In oncology, Moderna's Merck-partnered intismeran autogene (mRNA-4157) continues advancing across multiple indications including melanoma (Phase 3 fully enrolled), non-small cell lung cancer (two Phase 3 studies enrolling), and various Phase 2 studies in bladder and renal cancers. The addition of checkpoint therapy (mRNA-4359) to priority programs signals deepening oncology commitment.
The rare disease portfolio has shown early promise, with the propionic acidemia therapeutic (mRNA-3927) demonstrating potential decreases in metabolic decompensation events in early studies. The program has advanced to a registrational study, while the methylmalonic acidemia therapeutic (mRNA-3705) has secured FDA support through the START program with a registrational study planned for 2025.
With up to 10 products approaching approval, Moderna's platform is demonstrating versatility beyond COVID vaccines. However, the timeline to meaningful revenue contribution from these programs remains uncertain, creating a challenging gap between current financial performance and future potential.
Reports first quarter revenues of
Reiterates 2025 expected revenue range of
Announces reduction of
Advancing up to 10 products toward approval, including multiple oncology candidates
CAMBRIDGE, MA / ACCESS Newswire / May 1, 2025 / Moderna, Inc. (NASDAQ:MRNA) today reported financial results and provided business updates for the first quarter of 2025.
"In the first quarter, we continued to execute with financial discipline, significantly reducing our operating expenses, and further prioritized our investments in oncology," said Stéphane Bancel, Chief Executive Officer of Moderna. "Looking ahead, we are reiterating our 2025 financial framework and announcing a cost structure that is expected to reduce our annual operating expenses by approximately
Recent progress includes:
Commercial Updates
COVID-19: The Company reported
RSV: The Company reported
First Quarter 2025 Financial Results
Revenue: Total revenue for the first quarter of 2025 was
Cost of Sales: Cost of sales for the first quarter of 2025 was
Research and Development Expenses: Research and development expenses for the first quarter of 2025 decreased by
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of 2025 decreased by
Income Taxes: The Company recognized an income tax provision of
Net Loss: Net loss was
Loss Per Share: Loss per share was
Cash Position: Cash, cash equivalents and investments as of March 31, 2025, were
2025 Financial Framework
Expectations for full year 2025 remain consistent with prior expectations.
Revenue: The Company reiterates 2025 expected revenue of
Cost of Sales: Cost of sales for 2025 is expected to be approximately
Research and Development Expenses: Full-year 2025 research and development expenses are anticipated to be approximately
Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be approximately
Income Taxes: The Company continues to expect its full-year tax expense to be negligible.
Capital Expenditures: Capital expenditures for 2025 are expected to be approximately
Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately
2026 and 2027 Financial Updates
Moderna is expanding its cost efficiency and prioritization programs and expects estimated GAAP operating costs of
Recent Progress and Upcoming Late-Stage Pipeline Milestones
The Company continues to advance its research and development portfolio. Recently, Moderna updated its prioritized pipeline by adding its Phase 2 oncology candidate, checkpoint (mRNA-4359) therapy, and deprioritizing its flu/COVID combination vaccine (mRNA-1083) for adults aged 18-49.
Respiratory vaccines:
Next-generation COVID-19 vaccine: Moderna shared pivotal safety, immunogenicity and relative vaccine efficacy data for its next-generation COVID-19 vaccine (mRNA-1283) at the Advisory Committee on Immunization Practices meeting in April 2025. The Company filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher in 2024. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.
Respiratory syncytial virus (RSV) vaccine: The Company recently shared positive Phase 3 data for its RSV vaccine (mRNA-1345) in high-risk adults aged 18-59 at the ESCMID 2025 Global Congress. Moderna filed for regulatory approval of mRNA-1345 for high-risk adults with the FDA using a priority review voucher in 2024. The FDA has assigned a PDUFA goal date of June 12, 2025.
Seasonal flu + COVID vaccine: Moderna shared positive Phase 3 immunogenicity data for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at its 2024 R&D Day event. The Company submitted mRNA-1083 for regulatory approval in older adults in 2024. Based on FDA feedback confirming the need for Phase 3 flu efficacy data, Moderna expects an extended review timeline and is now targeting approval in 2026.
Seasonal flu vaccine: Moderna has shared positive Phase 3 immunogenicity and safety data for its seasonal flu vaccine (mRNA-1010). The Phase 3 vaccine efficacy study (P304) exceeded its case accrual target in the first season and Moderna anticipates an interim data readout in summer 2025.
Latent and other vaccines:
Cytomegalovirus (CMV) vaccine: The Company recently shared 36-month durability data from a Phase 2 extension trial of its CMV vaccine candidate (mRNA-1647) at the ESCMID 2025 Global Congress. The pivotal Phase 3 study of mRNA-1647 is fully enrolled and accruing cases, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. The Data Safety Monitoring Board (DSMB) met to review the initial study data in 2024 and informed the Company that the criterion for early efficacy was not met. The DSMB recommended that the study continue as planned. The Company remains blinded and anticipates efficacy data from the study in 2025.
Norovirus vaccine: The two-season Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna's trivalent vaccine against norovirus (mRNA-1403) is fully enrolled in the Northern Hemisphere and enrolling in the Southern Hemisphere. The FDA clinical hold following a single adverse event report of a case of Guillain-Barré syndrome has been lifted. The timing of the Phase 3 readout will be dependent on case accruals.
Oncology therapeutics:
Intismeran autogene: Moderna continues to demonstrate the potential clinical benefit of mRNA-4157. In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two Phase 3 studies for non-small cell lung cancer (NSCLC) are enrolling. A randomized Phase 2 study for high-risk muscle invasive bladder cancer is enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Moderna and Merck have launched a new Phase 2 study for patients with high-risk non-muscle invasive bladder cancer.
Checkpoint adaptive immune modulation therapy (AIM-T): Moderna is expanding the number of oncology development candidates in its prioritized pipeline with the addition of Checkpoint AIM-T (mRNA-4359). The Phase 1/2 study is ongoing and a Phase 2 study, which includes first-line melanoma and first-line metastatic NSCLC patients, is enrolling.
Rare disease therapeutics:
Propionic acidemia (PA) therapeutic: In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, Moderna's investigational therapeutic (mRNA-3927) has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Early results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. The Company's PA program is in a registrational study.
Methylmalonic acidemia (MMA) therapeutic: Moderna's investigational therapeutic for MMA (mRNA-3705) has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. The FDA and Moderna have agreed on the pivotal study design. The Company expects to start a registrational study in 2025.
Company Updates & Accolades
Moderna has been named to LinkedIn's list of Top Companies in the U.S. for the second consecutive year.
Moderna debuted on Fortune's annual list of America's Most Innovative Companies.
Key 2025 Investor and Analyst Event Dates
Analyst Day: November 20
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00 a.m. ET on May 1, 2025. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.
Telephone: https://register-conf.media-server.com/register/BI8c3608f9fdff4e00a5cb0cca952a4c3f
Webcast: https://investors.modernatx.com
The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID vaccines.
Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in millions, except per share data)
| Three Months Ended March 31, |
| ||||||
| 2025 |
|
| 2024 |
| |||
Revenue: |
|
|
|
|
|
| ||
Net product sales |
| $ | 86 |
|
| $ | 167 |
|
Other revenue1 |
|
| 22 |
|
|
| - |
|
Total revenue |
|
| 108 |
|
|
| 167 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of sales |
|
| 90 |
|
|
| 96 |
|
Research and development |
|
| 856 |
|
|
| 1,063 |
|
Selling, general and administrative |
|
| 212 |
|
|
| 274 |
|
Total operating expenses |
|
| 1,158 |
|
|
| 1,433 |
|
Loss from operations |
|
| (1,050 | ) |
|
| (1,266 | ) |
Interest income |
|
| 90 |
|
|
| 120 |
|
Other expense, net |
|
| (4 | ) |
|
| (19 | ) |
Loss before income taxes |
|
| (964 | ) |
|
| (1,165 | ) |
Provision for income taxes |
|
| 7 |
|
|
| 10 |
|
Net loss |
| $ | (971 | ) |
| $ | (1,175 | ) |
|
|
|
|
|
|
|
| |
Loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
| $ | (2.52 | ) |
| $ | (3.07 | ) |
|
|
|
|
|
|
|
| |
Weighted average common shares used in calculation of loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
| 386 |
|
|
| 382 |
|
1Includes grant, collaboration, licensing and royalty, and other miscellaneous revenue.
MODERNA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited, in millions)
| March 31, |
|
| December 31, |
| |||
| 2025 |
|
| 2024 |
| |||
Assets |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 1,623 |
|
| $ | 1,927 |
|
Investments |
|
| 4,352 |
|
|
| 5,098 |
|
Accounts receivable, net |
|
| 78 |
|
|
| 358 |
|
Inventory |
|
| 128 |
|
|
| 117 |
|
Prepaid expenses and other current assets |
|
| 585 |
|
|
| 599 |
|
Total current assets |
|
| 6,766 |
|
|
| 8,099 |
|
Investments, non-current |
|
| 2,418 |
|
|
| 2,494 |
|
Property, plant and equipment, net |
|
| 2,212 |
|
|
| 2,196 |
|
Right-of-use assets, operating leases |
|
| 752 |
|
|
| 759 |
|
Other non-current assets |
|
| 556 |
|
|
| 594 |
|
Total assets |
| $ | 12,704 |
|
| $ | 14,142 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 226 |
|
| $ | 405 |
|
Accrued liabilities |
|
| 1,001 |
|
|
| 1,427 |
|
Deferred revenue |
|
| 125 |
|
|
| 153 |
|
Other current liabilities |
|
| 252 |
|
|
| 221 |
|
Total current liabilities |
|
| 1,604 |
|
|
| 2,206 |
|
Deferred revenue, non-current |
|
| 58 |
|
|
| 58 |
|
Operating lease liabilities, non-current |
|
| 667 |
|
|
| 671 |
|
Financing lease liabilities, non-current |
|
| 35 |
|
|
| 39 |
|
Other non-current liabilities |
|
| 274 |
|
|
| 267 |
|
Total liabilities |
|
| 2,638 |
|
|
| 3,241 |
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
| 982 |
|
|
| 866 |
|
Accumulated other comprehensive income (loss) |
|
| 10 |
|
|
| (10 | ) |
Retained earnings |
|
| 9,074 |
|
|
| 10,045 |
|
Total stockholders' equity |
|
| 10,066 |
|
|
| 10,901 |
|
Total liabilities and stockholders' equity |
| $ | 12,704 |
|
| $ | 14,142 |
|
MODERNA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in millions)
| Three Months Ended March 31, |
| ||||||
| 2025 |
|
| 2024 |
| |||
Operating activities |
|
|
|
|
|
| ||
Net loss |
| $ | (971 | ) |
| $ | (1,175 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Stock-based compensation |
|
| 115 |
|
|
| 101 |
|
Depreciation and amortization |
|
| 39 |
|
|
| 36 |
|
Amortization/accretion of investments |
|
| (19 | ) |
|
| (27 | ) |
Loss on equity investments, net |
|
| 8 |
|
|
| 13 |
|
Other non-cash items |
|
| 2 |
|
|
| 3 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
| 280 |
|
|
| 755 |
|
Prepaid expenses and other assets |
|
| 46 |
|
|
| 3 |
|
Inventory |
|
| (8 | ) |
|
| (93 | ) |
Right-of-use assets, operating leases |
|
| 9 |
|
|
| 16 |
|
Accounts payable |
|
| (156 | ) |
|
| (303 | ) |
Accrued liabilities |
|
| (381 | ) |
|
| (398 | ) |
Deferred revenue |
|
| (29 | ) |
|
| (33 | ) |
Operating lease liabilities |
|
| (5 | ) |
|
| (6 | ) |
Other liabilities |
|
| 33 |
|
|
| 119 |
|
Net cash used in operating activities |
|
| (1,037 | ) |
|
| (989 | ) |
Investing activities |
|
|
|
|
|
|
|
|
Purchases of marketable securities |
|
| (1,764 | ) |
|
| (2,544 | ) |
Proceeds from maturities of marketable securities |
|
| 1,933 |
|
|
| 1,573 |
|
Proceeds from sales of marketable securities |
|
| 688 |
|
|
| 1,285 |
|
Purchases of property, plant and equipment |
|
| (117 | ) |
|
| (196 | ) |
Purchase of intangible asset |
|
| (10 | ) |
|
| - |
|
Net cash provided by investing activities |
|
| 730 |
|
|
| 118 |
|
Financing activities |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock through equity plans |
|
| 3 |
|
|
| 15 |
|
Tax payments related to net share settlements on equity awards |
|
| (1 | ) |
|
| - |
|
Changes in financing lease liabilities |
|
| 2 |
|
|
| (1 | ) |
Net cash provided by financing activities |
|
| 4 |
|
|
| 14 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
| (303 | ) |
|
| (857 | ) |
Cash, cash equivalents and restricted cash, beginning of year |
|
| 1,929 |
|
|
| 2,928 |
|
Cash, cash equivalents and restricted cash, end of period |
| $ | 1,626 |
|
| $ | 2,071 |
|
Spikevax® and mRESVIA® are registered trademarks of Moderna.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's 2025 financial framework, including its expected revenue range and ending cash balance; Moderna's advancement of up to 10 product approvals; Moderna's anticipated cost reductions by 2027; and anticipated milestones for Moderna's pipeline programs. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
###
Moderna Contacts
Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View the original press release on ACCESS Newswire
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