Merck & Co Stock Price, News & Analysis

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.

Merck and Eisai updated on two Phase 3 trials—LEAP-003 and LEAP-017—evaluating the anti-PD-1 therapy KEYTRUDA combined with LENVIMA. The LEAP-003 trial, which focused on adults with unresectable or metastatic melanoma, is being discontinued after an interim analysis indicated no improvement in overall survival (OS) compared to KEYTRUDA alone. However, a significant improvement in progression-free survival (PFS) was observed. The LEAP-017 trial, targeting metastatic colorectal cancer, also did not meet its OS primary endpoint, although a trend toward improvement was noted. Both trials maintained a consistent safety profile. The companies remain committed to further evaluations of KEYTRUDA plus LENVIMA in various cancers, with ongoing studies in the LEAP clinical program.