Fresenius Kabi received a Warning Letter, dated August 16, from the U.S. Food and Drug Administration (FDA) related to an April 2013 inspection of its Fenwal blood bag manufacturing plant in Maricao, Puerto Rico. Fresenius Kabi acquired Fenwal in December 2012.
The Warning Letter observations are primarily related to complaint-handling procedures, labeling issues, and filing of field alerts not in accordance with FDA regulations. The Warning Letter was not issued as a result of adverse events related to patient safety.
Following the inspection, Fresenius Kabi submitted a detailed remediation action plan to the FDA. The company has made significant progress in remedying the issues cited in the Warning Letter including improvements to its procedures and documentation. Production at the plant is continuing.
The company takes this matter very seriously and intends to respond in a timely and comprehensive manner to the Warning Letter. No material sales and earnings impact on Fresenius Kabi's business is expected. Fresenius Kabi fully confirms its 2013 guidance.
A copy of the FDA Warning Letter is attached to this document.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
September 09, 2015
London - UK
Bank of America Merrill Lynch – European Credit Loans Conference
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA OR JAPAN
Fresenius successfully placed US$300 million of senior unsecured notes with a maturity of 7 years.
The notes have a coupon of 4.50% and were issued at par.
The transaction was very well received by investors and substantially oversubscribed.
Fresenius US Finance II, Inc., a wholly owned subsidiary of Fresenius SE & Co. KGaA, offered the senior notes through a private placement to institutional investors.
Fresenius has applied to the Luxembourg Stock Exchange to admit the senior notes to trading on its regulated market.
This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in Australia, Canada, Japan, or the United States of America (the “United States”) or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The securities referred to herein may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent registration under the U.S. Securities Act of 1933, as amended (the “Securities Act”) except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. Subject to certain exceptions, the securities referred to herein may not be offered or sold in Australia, Canada or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to herein has not been and will not be registered under the Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States.
This announcement is an advertisement and not a prospectus. Investors should not purchase or subscribe for any securities referred to in this announcement except on the basis of information in the prospectus to be issued by the company in connection with the offering of such securities. Copies of the prospectus will, following publication, be available free of charge from Fresenius SE & Co. KGaA at Else-Kröner Strasse 1, 61352 Bad Homburg, Germany. The Notes have already been sold.
This announcement is directed at and/or for distribution in the United Kingdom only to (i) persons who have professional experience in matters relating to investments falling within article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (ii) high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons are referred to herein as “relevant persons”). This announcement is directed only at relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
The company's proprietary Freeflex IV containers allow easy handling with enhanced safety. Fresenius Kabi offers the broadest ropivacaine anaesthetics portfolio in the U.S.
According to IMS, Fresenius Kabi’s market share for Propofol and its equivalent, Diprivan, was 73% in November 2014 (October: 73%). Since March 2014, IMS data on our competition has included direct sales to hospitals. Fresenius Kabi does not report direct sales; our market share is therefore not fully reflected in IMS data.
Fresenius Kabi has received FDA approval for Neostigmine Methylsulfate Injection. Neostigmine is used after surgery to reverse the actions of drugs that block nerve and muscle function.
According to IMS, Fresenius Kabi’s market share for Propofol and its equivalent, Diprivan, was 75% in December 2014 (November: 73%). Since March 2014, IMS data on our competition has included direct sales to hospitals. Fresenius Kabi does not report direct sales; our market share is therefore not fully reflected in IMS data.
Revolving facilities and term loan A tranches (approx. €3 billion) under the 2013 senior credit agreement extended by 2 years to June 2020. Applicable credit margins reduced by approx. 50 basis points (subject to a leverage-based margin grid). Transaction substantially oversubscribed, more than 50 financial institutions participating.
The 66-bed hospital specializes in pulmonology, and will be affiliated to the nearby 540-bed HELIOS hospital Hildesheim. Closing of the transaction is expected April 1, 2015.
Argatroban injection expands Kabi's anticoagulant product portfolio. Now available as a 250mg/2.5mL presentation in a single dose vial.