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Fresenius is expanding its production capacity in Southeast Asia. Fresenius Kabi, a market leader in infusion therapy and clinical nutrition, opened a new production facility in the coastal city Quy Nhon in central Vietnam today. The opening ceremony was attended by Cornelia Pieper, the Minister of State at Germany's Federal Foreign Office, along with many other high-profile guests from Germany and Vietnam. Nearly 380 employees will work at the production facility. With the new plant, Fresenius Kabi will almost double its manufacturing capacity for infusion solutions and liquid medications. Most of these products are intended for the Vietnamese market. Investment costs totaled to approximately €20 million, and construction took about two years to complete.

Ulf Mark Schneider, CEO of Fresenius, said: "Health care systems in Vietnam and other countries in Southeast Asia are developing at a rapid pace, so there is a constantly increasing demand for Fresenius Kabi products in these countries. Our new plant in Quy Nhon will help us meet this demand and allow us to make a significant contribution to high-quality, yet affordable health care in the region."

Minister of State Cornelia Pieper highlighted the plant's role in German-Vietnamese relations: "I am pleased to see that Fresenius Kabi has opened a new plant in Quy Nhon. Direct investments such as these benefit both Germany and Vietnam. And they serve to secure jobs in both countries as well. What's more, they are an important part of our two countries working more closely together."

The new plant replaces the existing Fresenius Kabi production facility in Quy Nhon. Jan Walter, managing director of Fresenius Kabi for Vietnam, Cambodia and Laos, explained: "Over the last three years, our sales in Vietnam have grown by more than 20 percent every year. The new plant in Quy Nhon will significantly increase our production capacity and has the country's most advanced production equipment for infusion solutions and liquid medications. So we are well equipped for the further growth that we expect to see at Fresenius Kabi in Vietnam over the next few years."

The new production facility covers 15,000 square meters. The manufacture of infusion solutions is already certified in line with GMP (good manufacturing practice) guidelines as set down by the World Health Organization. Most of the employees from the former plant will be taken over, and 45 new jobs are being created.

The Quy Nhon plant is run by Fresenius Kabi Bidiphar JSC, a joint venture between Fresenius Kabi and Bidiphar, a state-owned health care company based in Quy Nhon. Fresenius Kabi Bidiphar was founded on December 1, 2008, and Fresenius Kabi holds the majority of its shares and provides the management team. The joint venture is Vietnam's market leader in standard solutions and also enjoys a leading position in I.V. generic drugs. Other Fresenius Kabi products made outside Vietnam are sold through a separate entity in Ho Chi Minh City. Overall, Fresenius Kabi employs nearly 500 people in Vietnam.

Fresenius has also been providing support for the Vietnamese-German University (VGU) in Ho Chi Minh City since 2008 to foster German-Vietnamese relations. The aim of this partnership is to set up and run the Fresenius Institute of Life Sciences, an institute that offers Vietnamese medical professionals training and continuing education. Among other measures, Fresenius has committed US$1 million to the project over a period of five years.

Note to media professionals: Images and video footage related to this press release and intended for editorial use can be downloaded at:
http://www.fresenius.de/quy-nhon

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The Supervisory Board of Fresenius Kabi AG today announced changes in the Management Board of Fresenius Kabi. Effective March 1, 2012 Mats Henriksson, who serves as Member of the Management Board of Fresenius Kabi AG and President of the region Asia Pacific, will be promoted to Deputy Chairman of the Management Board of Fresenius Kabi AG. On January 1, 2013 Mats will succeed Rainer Baule as President and CEO of the Management Board of Fresenius Kabi AG. The appointment of Mats Henriksson is part of the company's succession plan to ensure a smooth transition of leadership.

Effective March 1, 2012 Thomas Mechtersheimer, who has been Senior Vice President for Fresenius Medical Care South Asia Pacific, will join the Fresenius Kabi AG Management Board as Deputy Member and will assume the position of President of region Asia Pacific. As of January 1, 2013 Thomas Mechtersheimer will become a full Member of the Management Board of Fresenius Kabi AG.

Since May 2001, Rainer Baule has been responsible for Fresenius Kabi, the second largest business segment within Fresenius, specialized in i.v. drugs, infusion therapies and clinical nutrition for the hospital and the outpatient care. Over the course of his tenure, company sales tripled and the geographic footprint expanded substantially. Today, Fresenius Kabi counts among the leading companies in its business segments worldwide. Rainer, who turned 63 this year, joined Fresenius in 1997 as President of the former Fresenius HemoCare business segment and Member of the Management Board of Fresenius, before he took over the responsibility for Fresenius Kabi.

Mats Henriksson joined the company in 1999 as Member of the Management Board of Fresenius Kabi AG. Since 2001, he has been President of the region Asia Pacific. Under his leadership, Fresenius Kabi has seen continued strong growth in this region, which is proven by No 1 or No 2 market positions in most countries in Asia Pacific.

Before joining the company, Mats held several controlling and finance positions at Pharmacia & Upjohn. At the end of 1998, Pharmacia & Upjohn divested its Clinical Nutrition business to Fresenius and Mats became the Chief Financial Officer and Member of the Management Board of Fresenius Kabi AG. He is a Swedish citizen and studied Business Administration and Economics at the Gothenburg School of Economics, Sweden.

Thomas Mechtersheimer has been Senior Vice President for Fresenius Medical Care South Asia Pacific since 2007 and currently reports directly to Roberto Fusté, Chief Executive Officer of Fresenius Medical Care Asia Pacific. Over the years, Thomas significantly contributed to the growth of Fresenius Medical Care in Asia and has a deep understanding of the Asian market dynamics. Thomas joined Fresenius in 1995 and has since held several executive positions within the Asian organization. Prior to joining Fresenius Medical Care, he worked in Industrial Automation and Special Machinery companies, both in Sales as well as in Technical Services. Thomas studied International Business at the Reutlingen University, Germany.

Rainer Baule, CEO and President of Fresenius Kabi AG, said: "We are very pleased with the appointments of Mats as my successor and Thomas as new Board Member of Fresenius Kabi. Mats has an outstanding track record of results-oriented performance and successful management experience within Fresenius Kabi. This qualifies him perfectly to serve as CEO and President of Fresenius Kabi. Thomas is an excellent successor of Mats. With his extensive experience and his profound knowledge of the Asian Pacific market, I am confident Thomas will make significant contributions to continue the successful growth of Fresenius Kabi's business in this region. I look forward to working closely with both."

Ulf Mark Schneider, CEO of Fresenius and Chairman of the Supervisory Board of Fresenius Kabi AG, said: "Under Rainer Baule's leadership, Fresenius Kabi has grown significantly and developed into a global player in health care. This is the right time to begin a smooth transition of leadership. We are pleased to elevate Mats Henriksson to the new position of Deputy Chairman of Fresenius Kabi's Management Board. Building on his significant accomplishments in Asia Pacific, this role will prepare Mats for succeeding Rainer in leading the company. Thomas Mechtersheimer brings valuable international management experience and a deep understanding of the health care market dynamics that will be essential for the continued growth of our Fresenius Kabi business in Asia Pacific. Both appointments come from within Fresenius and this reflects the strength and depth of our management team. I am confident that Rainer, Mats and Thomas, along with their colleagues of the Fresenius Kabi Management Board, will continue to successfully grow the company".

New Management Board of Fresenius Kabi by March 1, 2012:

Rainer Baule
Chief Executive Officer (CEO) and Chairman of the Management Board

Mats Henriksson
Deputy Chairman of the Management Board

Marc Crouton
President of Region West & South Europe, Latin America & Africa

John Ducker
President Region North America

Manfred M. Köhler
President of Region Central/Eastern Europe, Nordics & Middle East

Thomas Mechtersheimer
Deputy Member and President Region Asia Pacific

Dr. Michael Schönhofen
President Science, Production & Technology

Gerrit Steen
Chief Financial Officer

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Fresenius sees excellent prospects for further sales and earnings growth in the coming years at its Fresenius Kabi business segment, whose management is updating analysts and investors on the company's operations, strategy and growth opportunities during a Capital Market Day at Group headquarters in Bad Homburg.

In the first months of 2012, Fresenius Kabi has recorded substantial organic growth across all regions and product segments, exceeding earlier expectations. Particularly in the U.S., revenue growth has been materially stronger than initially projected mainly due to ongoing IV drug shortages, including Propofol, which may continue well into the third quarter.

As a result, Fresenius Kabi raises its outlook for 2012. The company now expects organic sales growth of 7% to 9% and an EBIT margin between 20% and 20.5%. Previously, Fresenius Kabi projected organic sales growth of 6% to 8% and an EBIT margin at the upper end of a 19.5% to 20% range.

With ongoing strong growth in all Group business segments and Fresenius Kabi exceeding previous forecasts, Fresenius is raising its guidance for 2012. Fresenius Group now expects net income* to increase by 14% to 16% and sales** by 12% to 14%, both in constant currency and before effects of the announced Rhön-Klinikum AG acquisition. Previously, the Company projected net income growth of 12% to 15% and sales growth at the upper end of a 10% to 13% range, both in constant currency.

Fresenius Kabi specializes in the therapy and care of chronically and critically ill patients, providing intravenously administered generic drugs (IV drugs), infusion therapies, clinical nutrition, and related medical devices. Fresenius Kabi is the market leader in infusion therapy and clinical nutrition in Europe and holds leading positions in important countries of Latin America and the Asia-Pacific region. Within IV generic drugs, Fresenius Kabi is among the leading suppliers in the U.S. market. The company has more than 24,000 employees worldwide and a global network of 59 sales organizations as well as 61 production sites and compounding centers.

"Fresenius Kabi is showing strong growth across all regions and product segments and continues to build its global market presence. We are absolutely delighted with the progress the company is making," said Ulf Mark Schneider, CEO of Fresenius. "Fresenius Kabi is a major growth driver for us, clearly delivering above-market growth. The company will continue to benefit from two major global trends, the outstanding growth in emerging market healthcare spending and the increasing demand for high-quality IV generic drugs in light of numerous patent expirations and healthcare budget constraints in the Western world.''

In 2011, Fresenius Kabi posted sales of €3.96 billion and EBIT of €803 million, with both figures having more than doubled in the past five years. The compounded annual growth rate (CAGR) was 16% for sales and 23% for EBIT.

By 2015, the company expects sales to increase to approx. €5.5 billion and EBIT to reach more than €1 billion driven by rising demand for high-quality medical care in emerging markets, the continuing growth of generics, ongoing market consolidation, and demographic change in the industrialized countries.

In the key markets of Latin America and the Asia-Pacific region, Fresenius Kabi's strong local presence includes its own production, sales and marketing operations. China, where the company was active as early as 1982, has become Fresenius Kabi's third-largest market. The company today achieves 29% of total sales outside of Europe and North America – a share expected to reach 35% to 40% by 2015.

In established markets, meanwhile, the company projects continued strong growth of 5% to 7% annually, exceeding overall market growth. Due to its leading positions in many different product segments, combined with the high quality and availability of its products, Fresenius Kabi is a reliable partner for its customers. Expanding the product portfolio, and rolling it out into markets where only part of the overall product offering is now available, are key elements of Fresenius Kabi's growth strategy.
"We offer high-quality, affordable products for the therapy and care of critically and chronically ill patients," said Rainer Baule, CEO of Fresenius Kabi. "In our core therapeutic areas we can draw upon one of the most comprehensive product portfolios as well as a global network of marketing, sales and production sites. A high level of vertical integration and technological leadership in many areas provide us a highly competitive cost position, in turn leading to strong market positions. Fresenius Kabi is excellently positioned for further profitable growth.''

The Capital Market Day will be webcast on the Internet, starting at 9 a.m. CEST tomorrow (June 12, 2012). The webcast is available live at www.fresenius.com / Investor Relations/Presentations. A replay will be available shortly after the event.

* Net income attributable to shareholders of Fresenius SE & Co. KGaA – adjusted for a non-taxable investment gain of €30 million at Fresenius Medical Care; 2011 adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds and the Contingent Value Rights.
** Previous year's sales were adjusted according to a U.S. GAAP accounting change. The sales adjustment of -€161 million for the full year 2011 solely relates to Fresenius Medical Care North America.

(Financial statements according to U.S. GAAP)

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Conference Call and Live Webcast

Monday, July 23, 2012, 2.30 p.m. CEST



Fresenius Kabi has signed a definitive agreement to acquire Fenwal Holdings, Inc., a leading U.S.-based provider of transfusion technology products for blood collection, separation and processing, from TPG and Maverick Capital.

The acquisition marks another major step in Fresenius Kabi's growth strategy. The company had announced previously that expanding its medical devices/transfusion technology segment is a priority. Fresenius Kabi will now become a global leader in transfusion technology.

In 2011, Fenwal had sales of US$614 million with an adjusted EBITDA of US$90 million. The company, with about 4,900 employees worldwide, runs a state-of-the-art R&D center and operates five manufacturing facilities.

Ulf Mark Schneider, CEO of Fresenius, said: "Acquiring Fenwal is a unique opportunity to significantly expand Fresenius Kabi's medical devices/transfusion technology segment. In addition, Fresenius Kabi will benefit from a more balanced product portfolio. Fenwal gives Fresenius Kabi broader access to the U.S. transfusion technology market and adds new momentum to building a global market presence in this segment."

"The products, services, technologies and cultures of both companies fit extremely well together," said Ron Labrum, Fenwal president and chief executive officer. "We are committed to assuring a smooth integration with Fresenius Kabi and to bring our customers even more value as a result of this unique combination."

The two companies' business activities perfectly complement each other: Fenwal holds an excellent position in the market for automated blood collection devices, while Fresenius Kabi is a major supplier of blood bags and filters used for manual blood collection. Combining the two businesses will lead to the most comprehensive product portfolio in transfusion medicine.

In addition, the acquisition will enhance Fresenius Kabi's geographical presence. Fenwal, headquartered in Lake Zurich, Illinois, generates more than half its sales in the United States, where its infrastructure will serve as a platform for further growth opportunities for Fresenius Kabi. Vice versa, Fresenius Kabi's international network will expand Fenwal's global product reach. Significant potential for revenue and cost synergies will be created.

Around the world, approximately 92 million whole blood donations are collected annually*. The transfusion technology market is mainly driven by demographic developments and the growing demand for products for automated blood component processing. In addition, the increasing demand in emerging markets will lead to further growth in this product segment.

* www.who.int/worldblooddonorday/en/index.html


Financial terms were not disclosed. The transaction will be financed initially from existing funds, whereas the enterprise value does not exceed the proceeds of the May 2012 capital increase. Irrespective of acquiring Fenwal, Fresenius continues to assess its options for an acquisition of Rhön-Klinikum AG.

The transaction is subject to the necessary regulatory approvals by the relevant antitrust authorities, and is expected to close at the end of 2012.

Telephone Conference

A telephone conference will be held at 2.30 p.m. CEST on Monday, July 23, 2012. You are cordially invited to follow the conference call in a live broadcast via the Internet at www.fresenius.com, Investor Relations, Presentations. Following the call, a replay will be available on our website.

Automated and manual blood collection

Automated technology allows blood to be automatically separated into its therapeutic components, collecting only what is needed from donors — red blood cells, platelets, plasma, or therapeutic proteins. This enables blood centers to optimize each donation, limits further processing steps, and helps to ensure the right blood components are available in hospitals to meet patient needs.

During a manual blood collection the blood is collected from a donor and manually processed in a laboratory into its therapeutic components.

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Fresenius Kabi posted substantial organic growth across all regions and product areas during the first half of this year. The company is well on track for further strong growth in the second half. Demand in the United States is expected to remain high supported by ongoing IV drug shortages, particularly of Propofol. Supply constraints of a competitor for this anesthetic are now expected to last well into the fourth quarter.

As a result, Fresenius Kabi raises its outlook for 2012. The company now expects organic sales growth of approx. 9% and an EBIT margin of approx. 20.5%. Previously, Fresenius Kabi projected organic sales growth of 7% to 9% and an EBIT margin in the range of 20% to 20.5%.

Fresenius plans to invest the additional earnings contribution to reduce future interest expenses and optimize the maturity profile of the Group's financial liabilities.

Fresenius fully confirms its full-year guidance. For 2012, Fresenius expects net income ¹⁾ to increase by 14% to 16% in constant currency and sales growth ²⁾ in the range of 12% to 14% in constant currency.


¹⁾ Net income attributable to shareholders of Fresenius SE & Co. KGaA – adjusted for a non-taxable investment gain of €34 million at Fresenius Medical Care and for one-time costs related to the offer to the shareholders of RHÖN-KLINIKUM AG. 2011 adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds and the Contingent Value Rights.

²⁾ Previous year's sales were adjusted according to a U.S. GAAP accounting change. The sales adjustment of -€161 million for the full year 2011 solely relates to Fresenius Medical Care North America.

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Fresenius Kabi has successfully closed the acquisition of Fenwal Holdings, Inc., a leading U.S.-based provider of transfusion technology products for blood collection, separation and processing. The Fenwal acquisition was announced on July 20, 2012, and the closing now follows completion of the review by the antitrust authorities. Fenwal will be consolidated as of December 1, 2012.

For the fiscal year 2011, Fenwal reported sales of US$614 million and an adjusted EBITDA of US$90 million.

Fresenius expects one-time integration costs of approx. €100 million. Cost synergies should reach approx. €60 million annually in the medium term.

Fresenius Kabi fully confirms its 2015 outlook, which was raised on August 1, 2012. The company expects sales of approx. €6 billion and EBIT of >€1.1 billion at current exchange rates. Previously, Fresenius Kabi had targeted sales of approx. €5.5 billion and EBIT of >€1 billion.

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Fresenius Kabi has signed an agreement to sell its subsidiary Calea France SAS to The Linde Group. Calea is active in the French homecare market and focuses on respiratory therapy, which is not a core business of Fresenius Kabi.

Ulf Mark Schneider, CEO of Fresenus, said: "Calea is a successful business and will be a great fit in a global respiratory homecare organization. The divestiture underlines our strong commitment to focused growth in our four core business segments, where prospects for further expansion are bright."

In 2011, Calea France had sales of €28 million. The transaction is expected to be completed at the start of 2013.

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Fresenius Kabi received a Warning Letter, dated July 1, from the U.S. Food and Drug Administration (FDA) related to an inspection of its oncolytic API plant in Kalyani, India in January 2013. As a precautionary measure, production at the plant had been put on hold in January 2013. Fresenius previously informed about this inspection in February 2013.

The Warning Letter observations are related to GMP non-conformities regarding manufacturing, documentation practices and data integrity. Many of the data integrity items cited in the Warning Letter were self-identified by Fresenius Kabi post-inspection and shared with the FDA.

The company has made significant progress in remedying the issues cited in the Warning Letter. Based on a detailed remediation action plan submitted to the FDA, Fresenius Kabi has begun the process of restarting manufacture at the facility.

The company takes this matter very seriously and intends to comprehensively respond in a timely manner to the Warning Letter. Fresenius Kabi fully confirms its 2013 guidance which includes expected one-time charges to remediate the issues.

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Fresenius Kabi has formed a joint venture with PT Soho Global Health, a leading Indonesian pharmaceutical company, acquiring a 51 percent stake in its PT Ethica Industri Farmasi (EIP) subsidiary. This joint venture will focus on I.V. generic drugs and infusion solutions, and make Fresenius Kabi the market leader in I.V. generics in Indonesia.

Founded in 1946, EIP was the first manufacturer of injectable drugs in Indonesia. The company has a broad product portfolio and extensive experience and expertise in the production and marketing of generic drugs in the Indonesian market. EIP operates a production plant in Jakarta. The product portfolio of the future joint venture generated sales of more than €40 million last year.

Demand for health care in Indonesia has been growing steadily and is expected to accelerate in the coming years due to the implementation of a universal health care program, starting in 2014. As a result, almost the entire Indonesian population, about 245 million, is set to have access to modern health care by 2019*, with the country's pharmaceutical market expected to double to €7.1 billion by 2018**. The joint venture therefore provides an attractive platform for Fresenius Kabi's future growth in one of the fastest-growing emerging economies in Southeast Asia.

"Entering the joint venture brings us valuable local manufacturing capabilities and a strong market presence to provide patients and health care professionals in Indonesia with immediate access to high quality, affordable drugs," said Mats Henriksson, Chairman of the Management Board of Fresenius Kabi. "At the same time, we will establish a strong hub for further expanding our business in the Southeast Asian region. Our partner has many years of experience and a very good reputation serving the Indonesian health care market."

Tan Eng Liang, President Commissioner of PT Soho Global Health, said: "We are excited to be cooperating with Fresenius Kabi, because of the perfect fit between the companies. This joint venture gives us the possibility of strengthening our leading position in our home market as well as capturing the growth opportunities in the region in a fast and sustainable way. Together, we can boost the product pipeline with numerous launches in 2014 and beyond."

The parties agreed not to disclose the purchase price. Closing of the transaction is expected in the third quarter of 2013.

* Source: Ministry of Health, Republic of Indonesia, 2012

** IMS Market Prognosis Sep 2012, Dataview Date © IMS HEALTH

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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.