CERUS CORPORATION (NASDAQ:CERS) Files An 8-K Other EventsItem 8.01.
On May 23, 2017, Cerus Corporation (the “Company” or “Cerus”) announced that it had received notification last week of a pending U.S. supply shortage of a platelet additive solution (“PAS”) manufactured and sold by Fresenius Kabi Deutschland GmbH (“Fresenius Kabi”). The pending shortage is due to an unanticipated delay in U.S. Food and Drug Administration (“FDA”) approval of a plastic component used in the manufacture of the PAS container following discontinuation of the original component by Fresenius Kabi’s supplier. The shortage is expected to temporarily impact certain U.S. blood centers that utilize PAS to produce INTERCEPT platelets. Fresenius Kabi has stated that it is working with its suppliers and the FDA to resolve this delay and minimize any long-term disruption in supply. However, Cerus believes that the pending shortage could adversely affect INTERCEPT platelet production by impacted blood centers through year end.
Forward-Looking Statements
This report contains forward-looking statements, including, without limitation, statements relating to Cerus’ products and prospects, the supply shortage of PAS and its expected impact on U.S. blood centers that utilize PAS to produce INTERCEPT platelets, and Fresenius Kabi’s ability to address the pending supply shortage of PAS. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not realize meaningful revenue contributions from U.S. customers in 2017 or otherwise, particularly since Cerus cannot guarantee the volume or timing of commercial purchases, if any, that its U.S. customers may make under Cerus’ commercial agreements with these customers; risks related to the ability of Fresenius Kabi to remedy the causes for the PAS shortage in a meaningful and timely manner, if at all; risks related to how the supply shortage may affect current commercial contracts; risks related to how the supply shortage could affect INTERCEPT’s acceptance in the marketplace; and other risks detailed in Cerus’ filings with the U.S. Securities and Exchange Commission (the “SEC”), including under the heading “Risk Factors” in Cerus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the SEC on May 4, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. Cerus does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
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. CERUS CORPORATION (NASDAQ:CERS) Recent Trading Information
CERUS CORPORATION (NASDAQ:CERS) closed its last trading session down -0.75 at 2.25 with 9,827,794 shares trading hands.