8-K: Merck Reports Strong Fourth-Quarter and Full-Year 2024 Financial Results, Driven by Keytruda and Winrevair

• Merck & Co., Inc. reported its financial results for the fourth quarter and full year of 2024.
• Fourth-quarter worldwide sales reached $15.6 billion, a 7% increase compared to the same period in 2023, or 9% excluding foreign exchange impacts.
• Full-year worldwide sales were $64.2 billion, a 7% increase from 2023, or 10% excluding foreign exchange impacts.
• KEYTRUDA sales grew by 18% to $29.5 billion for the full year, or 22% excluding foreign exchange impacts.
• WINREVAIR sales reached $419 million for the full year.
• Animal Health sales grew by 4% to $5.9 billion for the full year, or 8% excluding foreign exchange impacts.
• GARDASIL/GARDASIL 9 sales declined by 3% to $8.6 billion for the full year, or 2% excluding foreign exchange impacts.
• GAAP EPS was $1.48 for the fourth quarter and $6.74 for the full year.
• Non-GAAP EPS was $1.72 for the fourth quarter and $7.65 for the full year.
• The company anticipates worldwide sales between $64.1 billion and $65.6 billion for the full year 2025.
• Non-GAAP EPS is expected to be between $8.88 and $9.03 for the full year 2025.

Score: 8

Explanation: The document presents a positive outlook with strong financial results and promising pipeline developments, indicating a healthy and growing company.

• Strong growth in KEYTRUDA sales, driven by increased global demand and uptake in various cancer indications.
• Successful launch and uptake of WINREVAIR, contributing significantly to cardiovascular franchise growth.
• Solid performance in the Animal Health business, driven by higher pricing and demand for both Livestock and Companion Animal products.
• Positive topline results from the Phase 3 MK-3475A-D77 trial of subcutaneous pembrolizumab.
• FDA acceptance of the Biologics License Application for clesrovimab, an investigational long-acting monoclonal antibody for RSV.
• Expanded approval of GARDASIL for males in China.
• Positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR in adults with pulmonary arterial hypertension (PAH).
• The company is continuing to progress its pipeline, advance key clinical programs and augment its pipeline through promising business development.

• GARDASIL/GARDASIL 9 sales declined by 3% for the full year, primarily due to lower demand in China.
• JANUVIA/JANUMET sales declined due to lower pricing in the U.S. and generic competition in international markets.
• LAGEVRIO sales decreased due to reduced demand for COVID-19 medication.
• SIMPONI sales decreased due to the transfer of marketing rights back to Johnson & Johnson.
• The company anticipates a negative impact of foreign exchange of approximately 2% on full-year 2025 sales.
• The company anticipates a negative impact of foreign exchange of approximately $0.35 per share on full-year 2025 non-GAAP EPS.
• Merck has decided to temporarily pause shipments of GARDASIL/GARDASIL 9 into China beginning February 2025 through at least mid-year.

• General industry conditions and competition could impact future performance.
• Fluctuations in interest rates and currency exchange rates pose financial risks.
• Pharmaceutical industry regulation and healthcare legislation could affect the company's operations.
• Global trends toward healthcare cost containment may impact revenue.
• Technological advances and new products from competitors could challenge Merck's market position.
• Manufacturing difficulties or delays could disrupt supply chains.
• Financial instability of international economies and sovereign risk could affect sales.
• Dependence on the effectiveness of patents and other protections for innovative products creates vulnerability.
• Exposure to litigation, including patent litigation, and/or regulatory actions could result in financial losses.

Merck anticipates worldwide sales to be between $64.1 billion and $65.6 billion and non-GAAP EPS to be between $8.88 and $9.03 for the full year 2025.

• 'We delivered strong growth in 2024, reflecting demand for our innovative portfolio, including for KEYTRUDA, which continues to benefit more patients with cancer globally, the successful launch of WINREVAIR and strong performance of our Animal Health business,' said Robert M. Davis, chairman and chief executive officer, Merck.
• 'Were continuing to progress our pipeline, advance key clinical programs and augment our pipeline through promising business development.
• Our business remains well positioned thanks to the dedication of our talented global team, and I am more confident than ever in our long-term growth potential.'

Merck's performance reflects the ongoing demand for innovative oncology and animal health products, as well as the successful launch of new cardiovascular treatments, positioning the company favorably within the competitive pharmaceutical landscape.

• Merck's Keytruda is a direct competitor to Bristol Myers Squibb's Opdivo in the PD-1 inhibitor market; Keytruda's $29.5 billion in sales demonstrates its market leadership.
• Merck's Gardasil competes with GSK's Cervarix in the HPV vaccine market; Gardasil's decline in sales due to China highlights the importance of geographic diversification.
• Merck's Animal Health division competes with Zoetis and Elanco; its 4% growth indicates a solid position in this market.
• The company's overall sales growth of 7% is comparable to other major pharmaceutical companies, such as Johnson & Johnson and Pfizer, but the growth of Keytruda is significantly higher than the average growth of oncology products.

• Shareholders can expect continued growth and potential returns based on the company's strong performance.
• Employees can anticipate stability and opportunities for advancement within a successful organization.
• Customers will benefit from access to innovative medicines and vaccines.
• Suppliers can expect continued business relationships with a financially stable company.
• Creditors can be confident in the company's ability to meet its financial obligations.

• Continue advancing clinical programs and augment the pipeline through business development.
• Complete the technology transfer for MK-2010.
• Await the final decision for EU approval of CAPVAXIVE.
• Prepare for the potential launch of clesrovimab pending FDA approval.

• 2025-01: Merck received expanded approval in China for GARDASIL for males 9-26 years of age.
• 2025-01: Merck announced the Phase 3 HYPERION study evaluating WINREVAIR in newly diagnosed adults with PAH with FC II or III at intermediate or high risk of disease progression was also stopped early.
• 2025-02-04: Date of report and earliest event reported.
• 2025-02-04: Merck announced fourth-quarter and full-year 2024 financial results.
• 2025-02: Merck will temporarily pause shipments of GARDASIL/GARDASIL 9 into China beginning February 2025 through at least mid-year.
• 2025-Q2: Final decision for EU approval of CAPVAXIVE for pneumococcal vaccination in adults is expected.
• 2025-06-10: PDUFA date for clesrovimab.