Merck Reports Robust Q2 Growth and Expands Drug Portfolio

Merck & Co., Inc. achieved notable growth in Q2 2024, with a 7% increase in global sales. Key drivers include strong performance from KEYTRUDA and stable sales of GARDASIL. The company advanced its drug development efforts, launching WINREVAIR for pulmonary arterial hypertension and securing FDA approval for CAPVAXIVE, a new pneumococcal vaccine. Despite facing challenges with GARDASIL sales in China, Merck revised its full-year sales outlook upwards and adjusted its EPS forecast to reflect recent acquisitions and currency impacts.

Merck Achieves 7% Sales Growth and Advances in New Drug Development

Merck & Co., Inc. (formerly known as MSD) reported global sales of $16.112 billion in the second quarter of 2024, a 7% increase over the same period last year. Excluding the impact of currency exchange rates, sales rose by 11%. Sales of lead product KEYTRUDA (pembrolizumab) were $7.27 billion, up 16%, reflecting strong demand in early-stage indications and approved therapeutic areas. Additionally, sales of the vaccine GARDASIL/GARDASIL 9 (nine-valent human papillomavirus vaccine) reached $2.478 billion, up 1%.

Merck made significant progress in new drug development. The company launched WINREVAIR (sotatercept), an innovative drug for pulmonary arterial hypertension (PAH), which achieved initial success in the US market. WINREVAIR also received positive approval from the European Medicines Agency (EMA). Moreover, the U.S. Food and Drug Administration (FDA) approved CAPVAXIVE (pneumococcal 21-valent conjugate vaccine) for preventing invasive pneumococcal disease and pneumonia in adults.

Financially, Merck’s earnings per share (EPS) were $2.14 on a GAAP basis and $2.28 on a non-GAAP basis. The company revised its full-year forecast, projecting global sales in the range of $63.4 billion to $64.4 billion.

Pipeline and Portfolio Highlights in Oncology, Vaccines and Cardiometabolic Fields

In Q2 2024, Merck advanced its pipeline with notable achievements across various therapeutic areas. The U.S. FDA approved CAPVAXIVE, a pneumococcal conjugate vaccine targeting serotypes responsible for most invasive pneumococcal disease cases in adults 65 and older. The Centers for Disease Control and Prevention (CDC) data from 2018-2021 supported this approval. The Advisory Committee on Immunization Practices (ACIP) recommended CAPVAXIVE for specific adult age groups and vaccination scenarios. Additionally, a supplemental dose is recommended for adults over 65 who completed their vaccine series with PCV13 and PPSV23.

Merck also announced positive topline results from its Phase 2b/3 trial of clesrovimab (MK-1654). This investigational monoclonal antibody targets respiratory syncytial virus (RSV) in infants and met all primary safety and efficacy endpoints. In cardiometabolic disease, Merck made significant strides with WINREVAIR, which reached over 1,000 patients in the U.S. The European Union’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for WINREVAIR, potentially making it the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved in Europe.

In oncology, Merck received FDA approval for KEYTRUDA in combination with chemotherapy and as a single agent for endometrial carcinoma, marking its 40th indication in the U.S. At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Merck presented new data on its oncology medicines and pipeline candidates. Additionally, Merck launched a 12-month injectable formulation of BRAVECTO for dogs in Europe and completed acquisitions, including Elanco Animal Health’s aqua business and Eyebiotech Limited. Merck also converted its co-development agreement with Orion Corporation into an exclusive global license for opevesostat (MK-5684/ODM-208).

Full-Year Sales Outlook Adjusted Amidst Strong Oncology Demand and Challenges in GARDASIL Sales

Merck sees robust global demand for its key growth products, especially in oncology. Despite challenges, including reduced GARDASIL sales through its distributor, Zhifei Biological Products Co., Ltd., in China, Merck is adjusting its full-year sales outlook upward and narrowing the forecast. Furthermore, Merck anticipates a full-year non-GAAP EPS between $7.94 and $8.04. This forecast includes one-time acquisition charges and a foreign exchange impact. The outlook accounts for significant charges related to EyeBio and estimated expenses for recent acquisitions. Non-GAAP EPS excludes various costs and includes a tax benefit from expiring tax assessments.

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Author

Bernice Lottering