CAMBRIDGE - Moderna, Inc. (NASDAQ: MRNA) today reported financial results and provided business updates for the first quarter of 2024.
'As we anticipate the launches of our Spikevax 2024-2025 formula and RSV vaccine, we are exercising financial discipline and have intensified our focus on building and utilizing AI technologies to further streamline operations and enhance productivity,' said Stephane Bancel, Chief Executive Officer of Moderna. 'With 10 late-stage programs, and additional new programs advancing toward pivotal studies, we continue to expect numerous product milestones this year across our vaccines and therapeutics portfolio. This is the start of a banner year for our vaccine platform as we continue to advance mRNA medicines for patients. This is just the beginning.'
Recent progress includes: Commercial Updates
COVID-19: The Company reported $167 million in Spikevax (COVID-19 vaccine) sales in the first quarter of 2024, which includes $100 million of U.S. sales and $67 million of international sales.
In the U.S., the Company is reaffirming its 2024 product sales outlook as it enters the second year of the commercial endemic COVID market. Moderna's focus is on working with public health officials, health care providers and pharmacies to increase vaccination coverage rates to reduce the substantial burden of COVID-19. Moderna is also working with the U.S. FDA and regulators to align the timing of flu and COVID-19 vaccine approvals, which is expected to result in higher vaccination uptake if vaccines are available sooner and offered at the same time as the flu shot.
In the European Union, Moderna 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.
In the Rest of World, the Company is prioritizing markets for greater commercial focus and in April announced a contract with the Ministry of Health in Brazil (Ministerio da Saude) to supply 12.5 million mRNA COVID-19 vaccines as an integral part of Brazil's 2024 national vaccination campaign against COVID-19.
RSV: The Company anticipates initial regulatory approvals of its RSV vaccine (mRNA-1345) beginning in the first half of 2024.
Moderna is targeting fall 2024 for its U.S. RSV vaccine launch, 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 clinical efficacy data, a well-established safety and tolerability profile for its mRNA technology, and as the only pre-filled syringe (PFS) product available.
The PFS ready-to-use formulation will save pharmacists and clinicians time, potentially alleviating wait times and reducing the burden on pharmacy staff. In a study funded by Moderna, the PFS presentation was three to four times more efficient than vaccines requiring reconstitution, measured in doses per hour and based on mean time of preparation.
First Quarter 2024 Financial Results
Revenue: Total revenue for the first quarter of 2024 was $167 million, compared to $1.9 billion in the same period in 2023. The decline was primarily due to reduced sales of the Company's COVID-19 vaccine. Net product sales for the first quarter of 2024 were $167 million, representing a 91% decline compared to the same period in 2023. This decline aligns with the anticipated transition to a seasonal COVID-19 vaccine market; in the prior year period, the Company recognized revenue primarily from delivered doses deferred from 2022.
Cost of Sales: Cost of sales for the first quarter of 2024 totaled $96 million, which included third-party royalties of $8 million, inventory write-downs of $30 million, and unutilized manufacturing capacity and winddown costs of $27 million. Cost of sales for the first quarter of 2024 decreased by $696 million, or 88%, compared to the same period in 2023. Cost of sales as a percentage of net product sales was 58% for the first quarter of 2024, compared to 43% for the first quarter of 2023. The decrease in cost of sales in 2024 was primarily driven by lower sales volume coupled with reduced unutilized manufacturing capacity, inventory write-downs and losses on firm purchase commitments and related cancellation fees. Conversely, the increase in cost of sales as a percentage of net product sales in 2024 was driven by the lower sales level compared to the prior year.
Research and Development Expenses: Research and development expenses for the first quarter of 2024 decreased by 6% to $1.1 billion, compared to the same quarter of 2023. This reduction was primarily due to the absence of upfront collaboration payments being made in 2024. The upfront payments made in the first quarter of 2023 were related to the Company's strategic collaborations with Generation Bio and Life Edit Therapeutics. Additionally, there was a decrease in clinical development and manufacturing expenses, driven by lower spending on clinical trials for the Company's COVID-19, RSV and seasonal flu programs, which aligns with its planned trial schedules. These decreases were partially offset by higher personnel-related costs, resulting from an increased headcount in the research and development functions.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the first quarter of 2024 decreased by 10% to $274 million, compared to the first quarter of 2023. This decrease is a result of cost discipline and the efficiencies resulting from investments the Company made in foundational capabilities over the last year, which allowed for a significant reduction of purchased services and the use of external consultants. The Company continues to invest in digital and commercial capabilities and has intensified its focus on building and utilizing AI technologies to further streamline operations and enhance productivity.
Income Taxes: Income tax expense for the first quarter of 2024 was $10 million, in contrast to an income tax benefit of $384 million in the same period last year. The shift primarily resulted from the continued application of a valuation allowance on the majority of the Company's deferred tax assets, first established in the third quarter of 2023. The Company only maintained a valuation allowance on certain state deferred tax assets prior to the third quarter of 2023.
Net Income (Loss): Net loss was $(1.2) billion for the first quarter of 2024, compared to net income of $79 million for the first quarter of 2023.
Earnings (Loss) Per Share: Diluted loss per share was $(3.07) for the first quarter of 2024, compared to diluted earnings per share of $0.19 for the first quarter of 2023.
Cash Position: Cash, cash equivalents and investments as of March 31, 2024, were $12.2 billion, compared to $13.3 billion as of December 31, 2023. The decrease in the Company's cash position during the first quarter of 2024 was largely attributable to research and development expenses and operating activities.
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-19 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.
Contact:
Chris Ridley
Tel: +1 617-800-3651
Email: Chris.Ridley@modernatx.com
Lavina Talukdar
Tel: +1 617-209-5834
Email: Lavina.Talukdar@modernatx.com
MODERNA, INC. 
