10-KPeriod: FY2015

Merck & Co., Inc. Annual Report, Year Ended Dec 31, 2015

Filed February 26, 2016For Securities:MRK

Summary

Merck & Co., Inc. reported total sales of $39.5 billion for the fiscal year ended December 30, 2015, representing a 6% decrease compared to the prior year, partly due to unfavorable foreign exchange rates and the divestiture of its Consumer Care segment. Despite the overall sales decline, the company experienced volume growth in key areas such as oncology (driven by Keytruda), diabetes, and vaccines, along with a positive performance in its Animal Health business. Significant product approvals and expanded indications in 2015 included Keytruda for advanced melanoma and metastatic non-small-cell lung cancer, and Bridion for surgical reversal of neuromuscular blockade. The company also advanced its pipeline with several drug candidates under regulatory review and in Phase 3 development, highlighting a strategic focus on innovation in critical therapeutic areas like cancer and diabetes. Merck continued its commitment to returning capital to shareholders, with $9.3 billion returned through dividends and share repurchases in 2015. The company is actively managing its cost structure through ongoing restructuring programs, which were substantially completed by the end of 2015, contributing to projected annual net cost savings. Management emphasizes a R&D-focused strategy, augmented by business development activities such as strategic acquisitions and collaborations, to enhance its product pipeline and address unmet medical needs.

Financial Statements
Beta

Key Highlights

  • 1Total sales for fiscal year 2015 were $39.5 billion, a 6% decrease from 2014, impacted by foreign exchange and divestitures.
  • 2Keytruda, Merck's anti-PD-1 therapy, showed significant growth and received expanded indications, particularly for melanoma and non-small-cell lung cancer.
  • 3The company acquired Cubist Pharmaceuticals in January 2015, strengthening its position in the hospital acute care market.
  • 4Merck received FDA approval for Bridion in December 2015, a medication used to reverse neuromuscular blockade during surgery.
  • 5Zepatier, a new treatment for chronic Hepatitis C, received FDA approval in January 2016.
  • 6Restructuring programs initiated in prior years were substantially completed by the end of 2015, meeting cost savings targets.
  • 7Merck returned $9.3 billion to shareholders in 2015 through dividends and share repurchases.

Frequently Asked Questions

Merck's sales in 2015 were driven by volume growth in oncology (Keytruda), diabetes (Januvia/Janumet), vaccines (Gardasil/Gardasil 9), and animal health products. However, overall sales declined by 6% compared to 2014, impacted by unfavorable foreign exchange and the divestiture of the Consumer Care business.

In 2015, Merck focused on advancing its pipeline and commercial portfolio through a strategy prioritizing R&D and business development. Key strategic actions included the acquisition of Cubist Pharmaceuticals, continued development and regulatory submissions for Keytruda, and restructuring programs aimed at cost management and efficiency improvements. The company also returned significant capital to shareholders.

Merck faces ongoing challenges from generic and biosimilar competition as its products mature. The company's strategy to mitigate this involves robust R&D to develop new innovative products, strategic business development (acquisitions and collaborations), and effective lifecycle management of existing products. The report highlights patent expirations for products like Cubicin and Zetia as areas of concern.

Merck's R&D efforts are concentrated on therapeutic areas with significant unmet medical needs, including cancer, Hepatitis C, cardiometabolic diseases, resistant microbial infections, and Alzheimer's disease. The company has several promising candidates in late-stage clinical development and under regulatory review across these areas.