In May 2024, the FDA approved Moderna's mRESVIA vaccine for RSV, marking the company's second approved mRNA product. This approval expands Moderna's product portfolio beyond COVID-19 and addresses a significant market for respiratory virus vaccines.

The company announced the discontinuation of five programs in its pipeline, including Endemic HCoV (mRNA-1287) and RSV infants (seronegative, <2 years) (mRNA-1345). This decision reflects a strategic prioritization of resources toward programs with higher potential.

Consistent with regulatory guidance, Moderna updated its COVID-19 vaccine to target the KP.2 and JN.1 strains of the SARS-CoV-2 virus for the 2024-2025 season. This demonstrates the company's ability to adapt its mRNA platform to address emerging variants and maintain market relevance.

In September 2024, Moderna's manufacturing facility in Laval, Quebec, received a Drug Establishment License from Health Canada. This certification marks a significant step in enabling the Canadian facility to become fully operational, supporting domestic manufacturing of mRNA vaccines.

The company's strategic cost initiative, launched in the third quarter of 2023 to optimize the COVID-19 business, helped drive improved manufacturing efficiency and cost reductions in 2024. This initiative involved resizing manufacturing operations in response to the shift toward an endemic seasonal market.

Selling, general, and administrative expenses decreased by $161 million, or 36%, for the three months ended September 30, 2024. The decrease reflects cost discipline and efficiencies gained by reducing reliance on external consultants and bringing more functions in-house.

In October 2024, GlaxoSmithKline Biologicals SA and Northwestern University filed complaints against Moderna alleging patent infringement related to lipid-mRNA vaccine formulation technology used in its COVID-19 and RSV vaccines. These lawsuits could result in significant legal expenses and potential damages.

In August 2024, a shareholder class action complaint was filed against Moderna and certain officers alleging claims under the Securities Exchange Act of 1934 regarding statements about its RSV vaccine (mRNA-1345). This lawsuit could result in significant legal expenses and potential damages.

The company notes that the COVID-19 vaccine market is transitioning from pandemic-driven demand to a more seasonal commercial pattern, with sales in 2024 exhibiting greater seasonality and reduced overall demand. This transition could lead to further reductions in net product sales.

Net product sales for the three months ended September 30, 2024 increased by $63 million, or 4%, compared to the same period in 2023, primarily driven by higher sales in the U.S. market following the earlier launch of our updated COVID-19 vaccine for the season.

In May 2024, the FDA approved Moderna's mRESVIA vaccine to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The company commenced sales in the U.S. in the third quarter of 2024.

In September 2024, Moderna announced that it is no longer pursuing an accelerated approval pathway for the regulatory submission of its standalone flu vaccine, mRNA-1010, to focus its resources on the submission of a potentially more impactful Flu+COVID combination vaccine, mRNA-1083. This decision reflects a strategic shift in its competitive approach to the respiratory vaccine market.

The company's strategic cost initiative, launched in the third quarter of 2023 to optimize the COVID-19 business, helped drive improved manufacturing efficiency and cost reductions in 2024. This initiative involved resizing manufacturing operations in response to the shift toward an endemic seasonal market.

Selling, general, and administrative expenses decreased by $161 million, or 36%, for the three months ended September 30, 2024. The decrease reflects cost discipline and efficiencies gained by reducing reliance on external consultants and bringing more functions in-house.

Inventory write-downs decreased for both the three and nine months ended September 30, 2024, compared to the same periods in 2023. This improvement suggests better alignment of inventory levels with expected demand.

Moderna has a diverse and extensive development pipeline of 36 development candidates across 45 development programs, of which 42 are in clinical studies currently. This demonstrates the company's commitment to leveraging its mRNA platform for a wide range of therapeutic applications.

In October 2024, Moderna and Merck initiated a Phase 3 study evaluating adjuvant INT (mRNA-4157) in combination with KEYTRUDA after neoadjuvant KEYTRUDA and chemotherapy in patients with certain types of resected non-small cell lung cancer. This is the third Phase 3 trial for the investigational INT.

Consistent with regulatory guidance, Moderna updated its COVID-19 vaccine to target the KP.2 and JN.1 strains of the SARS-CoV-2 virus for the 2024-2025 season. This demonstrates the company's ability to adapt its mRNA platform to address emerging variants and maintain market relevance.

As of September 30, 2024, $1.7 billion of the Board of Directors' authorization for repurchases of common stock remains outstanding, with no expiration date. This indicates the company's ongoing commitment to returning capital to shareholders.

The company continues to invest in research and development, particularly in ongoing Phase 3 studies for its next-generation COVID-19, seasonal flu, CMV, norovirus and combination vaccine programs, as well as its INT program.

In September 2024, Moderna entered into a purchase and sale agreement for the properties it currently leases in Norwood, Massachusetts, where the MTC is located. The total purchase price for the properties is approximately $370 million.

The provided document does not contain any information regarding Moderna's environmental, social, or governance initiatives.

The company notes that the COVID-19 vaccine market is transitioning from pandemic-driven demand to a more seasonal commercial pattern, with sales in 2024 exhibiting greater seasonality and reduced overall demand.

The company expects higher demand for its COVID-19 and RSV vaccines in the fall and winter seasons each year across both hemispheres, as countries prepare for seasonal vaccination campaigns.

The 10-Q filing mentions that GSK and Northwestern University filed complaints against Moderna alleging patent infringement related to lipid-mRNA vaccine formulation technology used in its COVID-19 and RSV vaccines. These lawsuits suggest increasing competitive pressure and potential challenges to Moderna's intellectual property.