Early Access

10-KPeriod: FY2016

Merck & Co., Inc. Annual Report, Year Ended Dec 31, 2016

Filed February 28, 2017For Securities:MRK

Summary

Merck & Co., Inc. reported total sales of $39.8 billion for the fiscal year ended December 30, 2016, a slight increase of 1% from the prior year, impacted by a 2% unfavorable foreign exchange effect. The Pharmaceutical segment remains the sole reportable segment, accounting for the vast majority of revenue. Key growth drivers included the oncology franchise, particularly Keytruda, alongside strong performance in Hepatitis C treatments (Zepatier) and vaccines. However, these gains were partially offset by declines in established products like Remicade and Nasonex due to generic and biosimilar competition. The company made significant investments in research and development, totaling $10.1 billion, reflecting its commitment to innovation and pipeline expansion. Merck also demonstrated a commitment to shareholder returns, raising its quarterly dividend and repurchasing shares. The company experienced significant IPR&D impairment charges in 2016, notably related to the uprifosbuvir program for HCV, highlighting the inherent risks in drug development. Legal settlements, including a substantial charge for Keytruda patent litigation, impacted the financial results. Overall, the company navigated a complex operating environment marked by pricing pressures and regulatory scrutiny, while strategically advancing its product portfolio and R&D pipeline.

Financial Statements
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Key Highlights

  • 1Total sales reached $39.8 billion in 2016, a 1% increase year-over-year, with unfavorable foreign exchange impacting results by 2%.
  • 2The Pharmaceutical segment is the sole reportable segment, showing growth driven by Keytruda (oncology), Zepatier (HCV), and vaccine products, partially offset by generic competition impacting Remicade and Nasonex.
  • 3Research and Development (R&D) expenses significantly increased by 51% to $10.1 billion in 2016, largely due to acquired in-process R&D impairment charges and increased clinical development spending.
  • 4The company settled worldwide patent litigation related to Keytruda, recording a pretax charge of $625 million in Q4 2016.
  • 5Merck returned $8.6 billion to shareholders in 2016 through dividends and share repurchases, with $5.1 billion in dividends paid.
  • 6Significant IPR&D impairment charges of $3.6 billion were recorded in 2016, primarily related to the uprifosbuvir program for HCV and discontinuation of other pipeline programs.
  • 7The company divested certain assets and acquired others, including Afferent Pharmaceuticals and IOmet Pharma Ltd., to bolster its pipeline and strategic focus.

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