Moderna today reported financial results and provided business updates for the fourth quarter and fiscal year 2023.

"2023 was a year of transition for Moderna as we adapted to the endemic market. At the same time, our development team made significant pipeline advancements across infectious diseases, oncology and rare diseases, while our commercial team increased our COVID-19 market share in the U.S.," said Stéphane Bancel, Chief Executive Officer of Moderna. "We look forward to the anticipated approvals of our RSV vaccine beginning in the first half of the year. With multiple upcoming Phase 3 data readouts in 2024, we remain focused on commercial execution and continued investment in our pipeline with financial discipline." 

Commercial Updates

COVID-19: The Company reported $2.8 billion in Spikevax (COVID-19 vaccine) sales in the fourth quarter of 2023, which includes $0.8 billion of U.S. sales and $2 billion of international sales. This led to $6.7 billion in vaccine sales for fiscal 2023, consistent with the previously communicated financial framework of at least $6 billion.

Moderna achieved 48% cumulative market share in the U.S. retail segment during the fall 2023 COVID season, up from 37% in 2022. Moderna took specific actions in 2023 to transition to a seasonal endemic market including the resizing of its manufacturing footprint to improve cash flow, the flattening of its commercial structure to drive sales execution, and the focusing of its investments toward near-term growth drivers.

The company is reaffirming its 2024 product sales outlook as it enters the second year of the U.S. commercial endemic COVID market with increased clarity of market size and dynamics. Moderna continues to focus on public health efforts to increase vaccination coverage rates globally for the 2024/2025 season to reduce the substantial burden of COVID-19. The Company is also prioritizing key international markets for greater commercial focus and is participating in the EU Health Emergency and Response Authority's tendering procedure for up to 36 million doses of mRNA COVID-19 vaccines per year for up to four years.

RSV: The company continues to expect initial regulatory approvals of its RSV vaccine (mRNA-1345) starting in the first half of 2024.

Moderna is well-prepared for the launch of its second respiratory vaccine, which will build upon the success of its commercial efforts in the fall COVID-19 market. The Company is encouraged by early indications of widespread consumer awareness and established demand in the RSV market, which Moderna will enter with a strong competitive profile with robust efficacy data, a well-established safety and tolerability profile, and as the only pre-filled syringe (PFS) product available at the time of launch. The PFS ready-to-use formulation will save pharmacists and clinicians time as well as potentially help reduce administration errors.

The PDUFA (Prescription Drug User Fee Act) action date for mRNA-1345 is May 12, 2024, by which time the Company expects the U.S. FDA's response to its Biologics License Application (BLA). If the outcome is positive, the Company anticipates that the U.S. CDC Advisory Committee on Immunization Practices (ACIP) will include mRNA-1345 on the agenda of its June 26-28 meeting. Assuming that corresponding marketing authorizations would be granted as expected, the Company also plans to launch its RSV vaccine in Australia and Germany in 2024 and other markets in 2025 due to regulatory and tender timing.

Fourth Quarter 2023 Financial Results

Revenue: Total revenue for the fourth quarter of 2023 was $2.8 billion, a decrease from $5.1 billion in the same period in 2022, primarily due to a reduction in sales of the Company's COVID-19 vaccine. Net product sales for the fourth quarter of 2023 were $2.8 billion, representing a 43% decline compared to the same period in 2022, primarily driven by lower sales volume, partially offset by a higher average selling price. Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance.

Cost of Sales: Cost of sales for the fourth quarter of 2023 totaled $929 million, which included third-party royalties of $125 million, or 33% of net product sales, compared to 39% of net product sales for the fourth quarter of 2022. In the third quarter of 2023, the Company embarked on a strategic initiative aimed at optimizing the cost structure of its COVID-19 business, with an emphasis on resizing its manufacturing cost structure. The initiative involved scaling down the Company's capacity and commitments with its third-party contract manufacturing organizations (CMOs), reevaluating its raw material inventory levels, and reducing its purchase commitments related to raw materials that were not expected to be consumed before expiration. As a part of this strategic effort during the fourth quarter of 2023, the Company incurred, as expected, additional charges of $169 million, primarily related to the wind-down of certain contract manufacturing operations. Additionally, cost of sales also includes an inventory write-down of $322 million, reflecting revised demand forecasts as the Company adapts to the end-of-season trends.

Research and Development Expenses: Research and development expenses for the fourth quarter of 2023 increased by 16% to $1.4 billion, compared to the same quarter of 2022. The growth in spending was largely driven by increased clinical manufacturing activities, notably with respect to the Company's RSV vaccine, cytomegalovirus (CMV) vaccine, combination vaccine against flu and COVID-19, as well as its individualized neoantigen therapy. The increase also included an upfront payment of $120 million associated with the strategic research and development collaboration with Immatics.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of 2023 increased by 25% to $470 million, in comparison to the fourth quarter of 2022. The growth in spending was primarily due to increased personnel-related costs and commercial and marketing expenses, driven by the expansion of commercial operations, particularly in the U.S. market.

Income Taxes: Income tax benefit for the fourth quarter of 2023 was $147 million, largely attributable to the tax benefits as part of finalizing our 2022 U.S. tax return.

Net Income: Net income was $217 million for the fourth quarter of 2023, compared to $1.5 billion for the fourth quarter of 2022, primarily driven by lower COVID-19 product sales.

Earnings Per Share: Diluted earnings per share was $0.55 for the fourth quarter of 2023, compared to $3.61 for the fourth quarter of 2022.

Full Year 2023 Financial Results

Revenue: Total revenue was $6.8 billion for the full year 2023, compared to $19.3 billion in 2022. The decrease in total revenue for 2023 was mainly due to a decline in sales of the Company's COVID-19 vaccine. Net product sales for 2023 were $6.7 billion, a decrease of 64% from 2022, driven by lower vaccination rates. Net product sales include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance.

Cost of Sales: Cost of sales for the full year 2023 was $4.7 billion, or 70% of net product sales, inclusive of third-party royalties of $301 million, inventory write-downs of $2.2 billion, unutilized manufacturing capacity and wind-down costs of $981 million, and losses on firm purchase commitments and cancellation fees of $205 million. Cost of sales includes a total of $1.6 billion, resulting from the Company's strategic initiative to resize its manufacturing cost structure that was launched in the third quarter of 2023. Cost of sales, as a percentage of net product sales, increased by 41 percentage points to 70%, from 29% in 2022. The increase in cost of sales as a percentage of net product sales was primarily due to the strategic initiative and other aforementioned charges (excluding royalties) over lower net product sales, driven by a decline in product demand and increased product seasonality.

Research and Development Expenses: Research and development expenses increased by 47% to $4.8 billion for 2023, compared to 2022. The increase in spending in 2023 was mainly attributable to increases in clinical trial and clinical manufacturing expenses, personnel-related costs, and consulting and outside services, largely driven by the Company's late-stage clinical studies for the RSV vaccine, CMV vaccine, combination vaccine against seasonal influenza and COVID-19, and the individualized neoantigen therapy program, as well as continued development of the Company's pipeline.

Selling, General and Administrative Expenses: Selling, general and administrative expenses increased by 37% to $1.5 billion for 2023, compared to 2022. The increase in spending in 2023 was primarily attributable to the Company's continued corporate expansion, particularly in the commercial area.

Income Taxes: Income tax provision for the full year 2023 was $772 million, which was primarily driven by a non-cash charge related to a valuation allowance on deferred tax assets.

Net Income (Loss): Net loss for the full year 2023 was $(4.7) billion, compared to a net income of $8.4 billion in 2022.

Earnings (Loss) Per Share: Diluted loss per share for the full year 2023 was $(12.33), compared to a diluted earnings per share of $20.12 in 2022.

Cash Position: Cash, cash equivalents and investments as of December 31, 2023, and December 31, 2022, were $13.3 billion and $18.2 billion, respectively. The decrease in cash position in 2023 was largely attributable to the full year's operating loss and the repurchases of the Company's common stock during the first half of the year.