CERUS CORPORATION (NASDAQ:CERS) Files An 8-K Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a RegistrantItem 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements related to the availability and funding of Term Loan B, the timing thereof and the satisfactions of the conditions thereto, including the Company’s achievement of the Revenue Milestone. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with
the satisfaction of the conditions to the funding of Term Loan B and the Company’s ability to maintain (and otherwise comply with the covenants in) the Amended Credit Agreement; risks associated with the Company’s ability to meet its debt service obligations; risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System; risks associated with the Company’s lack of commercialization experience in the United States and its ability to develop and maintain an effective and qualified U.S.-based commercial organization, as well as the resulting uncertainty of its ability to achieve market acceptance of and otherwise successfully commercialize the INTERCEPT Blood System for platelets and plasma in the United States; risks related to the Company’s ability to commercialize the INTERCEPT Blood System inthe United Stateswithout infringing on the intellectual property rights of others; risks related to the Company’s ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System is safe, effective and economical; the uncertain and time-consuming development and regulatory process, including the risks (a)thatthe Companymay be unable to comply with the FDA’s post-approval requirements for the INTERCEPT platelet and plasma systems, including by successfully completing required post-approval studies, which could result in a loss of U.S. marketing approval for the INTERCEPT platelet and/or plasma systems and (b)related to the Company’s ability to expand the label claims and product configurations for the INTERCEPT platelet and plasma systems inthe United States, which will require additional regulatory approvals; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or weakening economic conditions in the markets wherethe Companysells its products; the Company’s reliance on third parties to market, sell, distribute and maintain its products; the Company’s ability to maintain an effective manufacturing supply chain, including the ability of its manufacturers to comply with extensiveFDAand foreign regulatory agency requirements; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly forthe Companyto produce, market and distribute its products; risks related to future opportunities and plans, including the uncertainty of future revenues and other financial performance and results, as well as other risks detailed in the Company’s filings with theSecurities and Exchange Commission, including the Company’s Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2017, filed with theSEConMay 4, 2017. The Company disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this Current Report on Form 8-K.
About CERUS CORPORATION (NASDAQ:CERS)
Cerus Corporation is a biomedical products company. The Company is engaged in developing and commercializing the INTERCEPT Blood System for blood safety. The Company operates through blood safety segment. The Company’s INTERCEPT Blood System is based on its technology for controlling biological replication, and is designed to reduce blood-borne pathogens in donated blood components intended for transfusion. The Company’s INTERCEPT Blood System is designed to target and inactivate blood-borne pathogens, such as viruses, including human immunodeficiency virus (HIV), West Nile, Severe acute respiratory syndrome (SARS), hepatitis B and C; bacteria and parasites, as well as harmful white blood cells, while preserving the therapeutic properties of platelet, plasma and red blood cell transfusion products. The Company’s INTERCEPT Blood System is for use with blood components, including plasma, platelets, and red blood cells.
