10-KPeriod: FY2023

Merck & Co., Inc. Annual Report, Year Ended Dec 31, 2023

Filed February 26, 2024For Securities:MRK

Summary

Merck & Co., Inc. reported total sales of $60.1 billion for the fiscal year ended December 30, 2023, representing a 1% increase year-over-year (4% excluding foreign exchange impacts). This growth was primarily driven by strong performance in the oncology franchise, led by Keytruda, and the vaccines franchise, notably Gardasil/Gardasil 9. The company also saw increased alliance revenue from Lynparza and Lenvima, along with growth in hospital acute care and animal health products. However, these gains were partially offset by declines in the virology franchise, mainly due to lower sales of Lagevrio, and decreased sales in the diabetes segment from Januvia/Janumet. Merck continued to strengthen its pipeline and market position through strategic business development, including significant acquisitions such as Prometheus Biosciences and Imago BioSciences, and collaborations like the one with Daiichi Sankyo for antibody-drug conjugates. The company advanced numerous late-stage pipeline candidates and secured over 25 regulatory approvals in major markets during the year, highlighting continued innovation and expansion of its therapeutic offerings. Despite ongoing pricing pressures and global economic challenges, Merck remains focused on driving growth through its core therapeutic areas and expanding its reach in diverse markets.

Financial Statements
Beta

Key Highlights

  • 1Merck reported total sales of $60.1 billion, a 1% increase (4% excluding foreign exchange), driven by Keytruda, Gardasil/Gardasil 9, and strategic collaborations.
  • 2The oncology franchise, led by Keytruda ($25.0 billion sales), showed robust growth, with significant contributions from new indications and expanded global demand.
  • 3The vaccines franchise, particularly Gardasil/Gardasil 9 ($8.9 billion sales), experienced strong growth, driven by demand outside the U.S. and expanded indications.
  • 4Merck completed several key business development transactions in 2023, including the acquisitions of Prometheus Biosciences and Imago BioSciences, and a significant collaboration with Daiichi Sankyo for oncology ADCs, aimed at strengthening its pipeline.
  • 5Research and Development (R&D) expenses increased substantially to $30.5 billion, primarily due to business development activities, including significant charges for the Prometheus and Imago acquisitions and the Daiichi Sankyo collaboration.
  • 6The company received over 25 regulatory approvals in major markets, enhancing its product portfolio, especially in oncology, with Keytruda gaining approvals for multiple new indications.
  • 7Despite a decline in Lagevrio sales and ongoing pricing pressures globally, Merck maintained a strong financial profile and returned capital to shareholders through dividends and share repurchases.

Frequently Asked Questions

Merck's revenue in 2023 was primarily driven by its oncology franchise, particularly Keytruda, which generated $25.0 billion in sales. The vaccines franchise, led by Gardasil/Gardasil 9 ($8.9 billion in sales), also contributed significantly to revenue growth. Additionally, alliance revenues from collaborations for Lynparza and Lenvima, along with performance in hospital acute care and animal health, supported overall sales.

Merck is actively pursuing pipeline growth through substantial R&D investments and strategic business development. In 2023, the company made significant acquisitions, including Prometheus Biosciences and Imago BioSciences, and entered into major collaborations, such as the one with Daiichi Sankyo for oncology antibody-drug conjugates. These initiatives aim to diversify its portfolio and bring innovative treatments to market across various therapeutic areas.

Merck experienced a strong year for regulatory approvals, receiving over 25 approvals in major markets, with a particular focus on expanding Keytruda's indications across various cancer types. The company also advanced several late-stage pipeline candidates, such as sotatercept for pulmonary arterial hypertension and V116, a pneumococcal conjugate vaccine, which are under regulatory review. These advancements are crucial for sustaining future growth and offsetting potential patent expirations.

Merck reported total sales of $60.1 billion, a slight increase year-over-year, with strong growth in oncology and vaccines. However, R&D expenses rose significantly due to business development activities. Key challenges include ongoing pricing pressures globally, the impact of the Inflation Reduction Act on drug pricing, and the need to continuously innovate to replace revenue from products losing market exclusivity, such as Januvia/Janumet.