Merck (MRK -1.56%), a leading developer of prescription medicines, vaccines, and animal health products, released its second-quarter 2025 results on July 29, 2025. The most notable news was a beat on earnings per share, with non-GAAP EPS at $2.13 versus estimates of $2.02, a 5 % outperformance, even as GAAP revenue of $15.8 billion fell 0.58% short of consensus expectations. The quarter saw continued sales strength from its blockbuster oncology drug KEYTRUDA, which generated $8.0 billion in sales, but a steep drop in GARDASIL vaccine sales due to demand declines in China. Overall, the period highlighted both the resilience of Merck’s core oncology franchise and ongoing challenges in selected vaccine and international markets.

MetricQ2 2025Q2 2025 EstimateQ2 2024Y/Y Change
EPS (Non-GAAP)$2.13$2.02$2.28(6.6 % decrease)
Revenue (GAAP)$15.8 billion$15.90 billion$16.11 billion(-1.9 %)
Net Income (GAAP)$4.43 billion$5.46 billion(18.8 %)
Non-GAAP Net Income$5.37 billion$5.81 billion(7.7 %)
Gross Margin (Non-GAAP)82.2 %80.9 %+1.3 pp

Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report.

Company Overview and Key Success Drivers

Merck (MRK -1.56%) is a global pharmaceutical company specializing in innovative prescription medicines, vaccines, and animal health products. Its top-selling therapy is KEYTRUDA, an immuno-oncology drug that targets advanced and early-stage cancers across many indications. The company’s broader portfolio also includes important vaccines like GARDASIL (human papillomavirus vaccine), diabetes drugs, hospital acute care medicines, and a robust animal health division.

In recent years, Merck has focused on expanding its oncology franchise, accelerating research and development, and diversifying its product portfolio. Securing regulatory approvals, investing in large-scale manufacturing projects, and expanding in international markets are other key focus areas. The ability to successfully manage competition, adapt to evolving healthcare policy, and maintain a robust pipeline of novel therapies is essential for Merck’s ongoing success.

During the quarter, Merck saw a mixed revenue picture. The pharmaceutical segment recorded $14.1 billion in GAAP sales, down 2% from the prior year period, while the animal health division grew 11% to $1.65 billion, supported by strong livestock product demand and acquisition gains. The performance was anchored by KEYTRUDA, an immunotherapy for cancer, which delivered $8.0 billion in global sales, up 9% year-over-year, reflecting continued uptake across more cancer types and earlier treatment stages. The animal health unit also benefited from the Elanco acquisition, pushing livestock product sales up by 15%.

However, GARDASIL and GARDASIL 9, vaccines to prevent HPV-related diseases, generated $1.1 billion in sales, down 55% compared to last year (GAAP). The company cited a dramatic retreat in demand from China as the primary reason for this drop, with GARDASIL sales outside China were down 3% in the second quarter of 2025. Management withdrew its previous long-term target for GARDASIL due to sustained volatility in the Chinese market, as disclosed in the prior quarter's (Q1 2025) earnings call. The diabetes franchise, led by JANUVIA and JANUMET, remained mostly flat, with a slight 1% sales decrease.

Newer products began contributing meaningfully. WINREVAIR, a therapy for pulmonary arterial hypertension (a rare heart-lung condition), saw accelerated sales since its launch, reaching $336 million compared to $70 million in Q2 2024. CAPVAXIVE, a 21-valent pneumococcal conjugate vaccine, saw $129 million in GAAP sales as it built market adoption following its release in late 2024. Hospital acute care products, such as BRIDION, maintained stable revenues.

Merck’s gross margin improved to 82.2% on a Non-GAAP basis, 1.3 percentage points higher than last year, primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs. Sales, general and administrative expenses (non-GAAP) declined 2%, while research and development expenses (GAAP) jumped 16% due to a $200 million upfront licensing charge and broader clinical pipeline activities. Merck also started a $3.0 billion cost-optimization initiative, with restructuring costs rising, and expects these savings to be reinvested in growth projects.

The company’s results included several notable one-time items: the upfront licensing expense for the Hengrui deal and incremental restructuring expenses as part of cost transformation.

From a regulatory standpoint, Merck reported several approvals. KEYTRUDA earned new U.S. approval in head and neck cancer. New vaccine indications and EU approvals were also secured for products such as ENFLONSIA (RSV prevention in infants) and WELIREG in Japan. The company’s active acquisition strategy continued with the $10 billion Verona Pharma agreement for Ohtuvayre (a chronic obstructive pulmonary disease, or COPD, inhaled therapy), expected to close in Q4 2025.

Competitive pressures remain significant. Regulatory and pricing changes globally, especially those linked to the Inflation Reduction Act in the U.S. and shifting tariffs, have also put pressure on top-line growth and cost forecasts.

International markets accounted for about half of all sales in 2024, but also drove recent volatility, chiefly due to China’s vaccine market and the completion of a major HPV vaccination campaign in Japan. Approximately $200 million in tariff expenses were already factored into Merck’s full-year 2025 forward guidance, and currency movements remained a mild drag.

Looking Forward: Financial Outlook and Priorities

For fiscal 2025, Merck updated its financial guidance. It now projects full-year GAAP sales between $64.3 billion and $65.3 billion, a narrowed but steady range from previous outlooks, incorporating the added cost of tariffs and the Hengrui license charge. Non-GAAP EPS is now expected between $8.87 and $8.97. Management also reaffirmed a Non-GAAP gross margin goal of roughly 82%. Restructuring savings targeted at $3.0 billion annually by 2027 are planned to be fully reinvested to support new product launches and the pipeline across multiple therapeutic areas.

The company continues to invest heavily in new manufacturing, including a $1.0 billion U.S. facility for KEYTRUDA production and an $895 million expansion of animal health manufacturing.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.