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Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, is a renowned American multinational pharmaceutical company headquartered in Rahway, New Jersey. Originally the American arm of Germany's Merck Group founded in 1668, Merck has established itself as a global leader in pharmaceuticals and vaccines.
Merck's core business is the development and manufacturing of medications and vaccines spanning several therapeutic areas such as cardiometabolic diseases, cancer, and infections. The company's immuno-oncology platform, particularly strong in cancer treatment, is a significant revenue driver. The firm’s oncology portfolio includes groundbreaking immunotherapies like KEYTRUDA, designed to treat melanoma and other cancers. KEYTRUDA, in combination with other therapies, has shown promising results in reducing cancer recurrence and improving survival rates.
Merck also boasts a robust vaccine business, offering vaccines for pediatric diseases and human papillomavirus (HPV). Their commitment to public health extends to Merck for Mothers, an initiative aimed at improving maternal health globally. In 2024, Merck surpassed its goal early by reaching over 30 million women with programs promoting safe, high-quality maternal care.
The company's animal health division is another sector of its diverse operations, providing solutions to improve animal health and productivity.
From a geographical perspective, nearly half of Merck's sales are generated in the United States. Financially, Merck maintains a solid position with ongoing investments in research and development to fuel innovation. The company is actively engaged in numerous partnerships and collaborative research initiatives to accelerate the development of new therapies.
Merck’s mission is rooted in scientific excellence and an unwavering commitment to improving lives. The company continues to invest in leading-edge research, with over 2,250 ongoing clinical trials, including more than 1,600 trials evaluating combination regimens. This dedication underpins Merck's strategy to address complex health challenges and advance global health.
Merck (MRK) reported its first-quarter 2023 financial results, highlighting a 9% year-over-year decline in total worldwide sales to $14.5 billion. However, excluding LAGEVRIO sales, the growth was 11% and 15% when factoring out foreign exchange impacts. KEYTRUDA sales surged 20% to $5.8 billion, while GARDASIL sales rose 35% to $2.0 billion. In contrast, LAGEVRIO's sales plummeted 88% to $392 million. The company reported a GAAP EPS of $1.11 and a non-GAAP EPS of $1.40, both reflecting a 35% decline from the previous year, largely due to acquisition charges. Merck also announced a proposed acquisition of Prometheus Biosciences, valued at approximately $10.8 billion, to bolster its immunology pipeline. The financial outlook for 2023 has been narrowed, with expected sales between $57.7 billion and $58.9 billion.
Merck (NYSE: MRK) announced the results from the Phase 3 KEYNOTE-966 trial, presented at the AACR 2023 Annual Meeting, showing that KEYTRUDA combined with standard chemotherapy significantly improved overall survival (OS) for patients with advanced biliary tract cancer (BTC). The trial reported a 17% reduction in the risk of death with KEYTRUDA therapy, yielding a median OS of 12.7 months versus 10.9 months for chemotherapy alone. One-year OS rates were 52% for the KEYTRUDA group compared to 44% in the control. These findings will be submitted to regulatory authorities worldwide. The safety profile was consistent with prior studies, with grade 3-4 treatment-related adverse events in 70% of patients receiving KEYTRUDA.
Moderna and Merck announced positive results from the Phase 2b KEYNOTE-942 trial involving mRNA-4157 (V940) in combination with KEYTRUDA for treating high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone. The trial included 157 patients with a median follow-up of 23-24 months. In the combination group, 83.4% of patients were recurrence-free at 12 months, compared to 77.1% in the control group. The U.S. FDA granted Breakthrough Therapy Designation for this therapy. A Phase 3 study will start in 2023.
Merck (NYSE: MRK) has received acceptance from the FDA for a supplemental Biologics License Application (sBLA) for KEYTRUDA, its anti-PD-1 therapy, in combination with chemotherapy for patients with HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This decision is based on the Phase 3 KEYNOTE-859 trial, which demonstrated a significant overall survival benefit compared to chemotherapy alone, irrespective of PD-L1 expression. The FDA has a target action date of December 16, 2023. Merck is committed to expanding treatment options for gastric cancer patients, a group with a five-year survival rate of only six percent.
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