As the Company’s products lose market exclusivity, the Company generally experiences a significant and rapid loss of sales from those products.
Key products generate a significant amount of the Company’s profits and cash flows, and any events that adversely affect the markets for its leading products could have a material adverse effect on the Company’s results of operations and financial condition.
The Company’s research and development efforts may not succeed in developing commercially successful products and the Company may not be able to acquire commercially successful products in other ways; consequently, the Company may not be able to replace sales of successful products that lose patent protection.
The Company’s success is dependent on the successful development and marketing of new products, which are subject to substantial risks.
The Company faces continued pricing pressure with respect to its products.
Unfavorable or uncertain economic conditions, together with cost-reduction measures being taken by certain governments, could negatively affect the Company’s operating results.
The Company faces intense competition from both lower cost generic products and competitors’ products.
The Company has significant global operations, which expose it to additional risks, and any adverse event could have a material adverse effect on the Company’s results of operations and financial condition.
Climate change or legal, regulatory or market measures to address climate change may negatively affect the Company’s business, results of operations, cash flows and prospects.
Failure to attract and retain highly qualified personnel could affect the Company’s ability to successfully develop and commercialize products.
The Company may experience difficulties and delays in manufacturing certain of its products, including vaccines.
The Company may not be able to realize the expected benefits of its investments in emerging markets.
The Company is exposed to market risk from fluctuations in currency exchange rates and interest rates.
Pharmaceutical products can develop unexpected safety or efficacy concerns.
Reliance on third-party relationships and outsourcing arrangements could materially adversely affect the Company’s business.
Negative events in the animal health industry could have a material adverse effect on future results of operations and financial condition of the Company or its Animal Health business.
Biologics and vaccines carry unique risks and uncertainties, which could have a material adverse effect on the Company’s future results of operations and financial condition.
The Company’s products, including products in development, cannot be marketed unless the Company obtains and maintains regulatory approval.
Developments following regulatory approval may adversely affect sales of the Company’s products.
The Company is subject to evolving and complex tax laws, which may result in additional liabilities that may affect results of operations and financial condition.
Adverse outcomes in current or future legal matters could negatively affect Merck’s business.
Product liability insurance for products may be limited, cost prohibitive or unavailable.
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