Getinge Ab Class B · OMXSTO:GETI_B

Getinge Ab Class B — Corporate Update (February 2015)

8 slides from Getinge Ab Class B's corporate update, Feb 4, 2015

  1. Slide 1: Medical Systems FDA - Consent Decree

    Medical Systems FDA - Consent Decree Johan Malmquist, CEO February 4, 2015 Page 1

  2. Slide 2: FDA update

    FDA update Background  In 2013, FDA inspected 10 of Medical Systems manufacturing facilities, which generated observations related to the quality management system.  As previously disclosed, Getinge has committed substantial investments, SEK 995 million, into the remediation work to strengthen the

  3. Slide 3: Agreement reached with FDA

    Agreement reached with FDA Consent Decree  Getinge has now reached an agreement with the FDA concerning a consent decree.  A consent decree is a legal agreement entered into voluntarily by a company and the U.S. Government and sets forth a process for completing the required improvements.  The Co

  4. Slide 4: Agreement reached with FDA

    Agreement reached with FDA Consent Decree  Atrium will be subject to some manufacturing and delivery restrictions.  Some products (vascular grafts and surgical meshes) manufactured at Atrium, Hudson, New Hampshire, will be temporarily suspended, once inventory at Medical Systems distribution facil

  5. Slide 5: Financial impact

    Financial impact Consent Decree  The overall financial impact, excluding the already disclosed remediation cost, related to the consent decree is estimated to amount to SEK 500 million.  The entire amount will negatively impact the operating profit for 2015.  The SEK 500 million includes an initi

  6. Slide 6: Page 6

    GETINGE GROUP

  7. Slide 7: Forward-looking Information

    Forward-looking Information This document contains forward-looking information based on the current expectations of the Getinge Group’s management. Although management deems that the expectations presented by such forward-looking information are reasonable, no guarantee can be given that these expec

  8. Slide 8: Getinge Group

    Getinge Group is a global leading medical technology company that operates in the areas of surgery, intensive care, infection control, care ergonomics and wound care. Getinge Group has more than 15,000 employees in over 40 countries and generates sales exceeding SEK 25 billion (2013). The Group is d

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