Fresenius Kabi has been informed by the U.S. Food and Drug Administration that its pharmaceutical manufacturing facility in Grand Island, N.Y., has achieved the upgraded status of voluntary action indicated (VAI) following an October 2014 inspection. The status change is an improvement from the "official action indicated" status the facility had been operating under.

The new VAI classification permits FDA approval of new Fresenius Kabi products at the plant.

The status change reflects the improvements that have been made at the plant since receiving a warning letter in 2012. Fresenius Kabi remains committed to continuous improvement and compliance in its operations worldwide.

Fresenius Kabi has sold its German subsidiary CFL GmbH to NewCo Pharma GmbH, a compounding company founded by pharmacist Michael Schill. Both companies specialize in IV oncology drug compounding.

Fresenius Kabi will remain active in compounding. In Germany the focus will be on parenteral nutrition products, an area that offers attractive growth opportunities.

In 2014, CFL had sales of €77 million. Financial terms of the transaction were not disclosed.

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.

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

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.

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* to increase by 14% to 16% in constant currency and sales growth** in the range of 12% to 14% in constant currency.

 

*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.

**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.

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.

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.

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. 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."

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 Kabi, a business segment of health care group Fresenius, continues its growth strategy in intravenously administered drugs (i.v. drugs). The company today announced the acquisition of 73.3 % of the share capital of the Indian company Dabur Pharma Ltd. for a price of INR 8,782 million (€ 139 million) or INR 76.50 per share in cash. In accordance with Indian regulations, Fresenius Kabi also announced a public offer to acquire up to a further 20 % shareholding for a price of INR 76.50 per share in cash. Fresenius Kabi has entered into an agreement with a third party to secure the participation of 2.4 % of Dabur Pharma's share capital in the public offer.

Dabur Pharma, headquartered in New Delhi, is one of the leading suppliers of generic drugs and active pharmaceutical ingredients (API) to treat cancer. The company holds a substantial number of drug registrations in Asia, Europe and the US. Dabur Pharma is also one of the few manufacturers worldwide to hold international registrations for all steps within the manufacturing process of cytostatic agents. The company operates two production facilities in India and one in Great Britain as well as a research and development center equipped in accordance with European and US standards near New Delhi.

The acquisition significantly expands Fresenus Kabi's i.v. drug portfolio and secures its supply of high quality APIs for cytostatics. With the acquisition of Dabur Pharma, Fresenius Kabi will also broaden its offering of patient-specific oncology therapies. In future, Dabur Pharma will supply Fresenius Kabi's compounding centres in Europe, Asia-Pacific and Latin America where patient-specific formulations of i.v. drugs and parenteral nutrition are being prepared for cancer patients.

Dabur Pharma is listed on the Bombay Stock Exchange and on the National Stock Exchange of India. The company achieved sales of more than € 41 million with generic oncology drugs and APIs in fiscal year 2006/2007 (April 1, 2006 to March 31, 2007) and employs about 960 people. Dabur Pharma pursues an international growth strategy and will benefit from Fresenius Kabi's international sales and marketing organization going forward. In addition, Dabur Pharma will continue to be focused on expanding its research and development.

The acquisition will be entirely debt-financed from funds that have already been procured. The transaction is expected to be accretive to Fresenius Group's Cash EPS in 2 - 3 years.

Closing of the transaction is subject to completion of the public offer process in line with local regulations as well as relevant approvals required under Indian law. This is expected to occur at the beginning of Q3 2008.


Conference Call
A conference call to inform about the acquisition will be held on April 21, 2008 at 4.00 p.m. CEDT. All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com / Investor Relations / Presentations. A replay of the call will be available on our website shortly after the call.

Fresenius Kabi, a business segment of the health care group Fresenius, has signed definitive agreements to acquire APP Pharmaceuticals, Inc. APP is a leading manufacturer of intravenously administered generic drugs (I.V. generics) in North America. The company is listed on the NASDAQ Stock Market.

APP shareholders will receive a Cash Purchase Price of US$ 23.00 per share and a registered and tradeable Contingent Value Right (CVR) that could deliver up to US$ 6.00 per share, payable in 2011, if APP exceeds a cumulative adjusted EBITDA target for 2008 to 2010.

Based on the Cash Purchase Price, the transaction values the fully diluted equity capital of APP at approximately US$ 3.7 billion. Fresenius expects the acquisition to be neutral to EPS in the first year and clearly accretive from the second year onwards.

The acquisition is an important step in Fresenius Kabi's growth strategy. Through the acquisition of APP, Fresenius Kabi enters the U.S. pharmaceuticals market and achieves a leading position in the global I.V. generics market. This North American platform provides further attractive growth opportunities for Fresenius Kabi's existing product portfolio.
APP focuses on I.V. generics for hospital use and distributes its products in the U.S. and Canada. The company employs around 1,400 people and has state-of-the-art production facilities in Illinois, New York and Puerto Rico as well as a subsidiary in Toronto, Canada.

With a portfolio of more than 100 products, comprising drugs for oncology, intensive care, anaesthesia, analgesia as well as drugs for the treatment of infections, APP holds an important position in the North American hospital market. The company has a strong drug registration pipeline covering all of its product segments.

In 2007, APP achieved sales of US$ 647 million and an adjusted EBITDA of US$ 253 million. The company's latest published guidance for 2008 forcasts sales in a range of US$ 730 million to US$ 750 million and an adjusted EBITDA in a range of US$ 285 million to US$ 300 million.

As part of this transaction APP will merge with a U.S. subsidiary of Fresenius Kabi. The definitive agreements include a written consent and voting agreement with Dr. Patrick Soon-Shiong, APP's founder and shareholder of over 80 % of the outstanding stock. The transaction has been approved by APP's Board of Directors.

Following the closing of the transaction, Patrick Soon-Shiong will serve as a non-executive director on the Board of Fresenius Kabi's U.S. Holding company. In this role, he will continue to contribute to the company's strategic development.

Dr. Ulf Mark Schneider, Chairman of the Management Board of Fresenius SE commented: "APP is a fast-growing, highly profitable company and a strong management team that has an excellent market position in the U.S. Our firm very much shares APP's dedication to quality and medical excellence for the benefit of patients. The acquisition provides significant growth opportunities for Fresenius Kabi. With the APP platform, Fresenius Kabi will be able to market its product range in the U.S. Fresenius Kabi's international marketing and sales network will allow us to sell APP's products globally. We welcome APP employees to our team and very much look forward to serving the North American healthcare community."

Patrick Soon-Shiong said: "We are proud to have consistently provided injectable pharmaceutical products of the highest quality to patients in the acute care setting over the past decade. In Fresenius we have found a partner with the same commitment to quality and dedication to patient care. The combined company will allow for the rapid globalization of APP's portfolio with the same high levels of quality and patient commitment for which we have become known, while at the same time providing a more comprehensive and complementary offering of injectable pharmaceuticals, devices and delivery systems to customers worldwide."

It is planned to finance the acquisition with a mix of debt and equity, targeted to minimize the impact on Fresenius SE's credit ratings. However, given Fresenius' rapid progress in de-levering since 2006, the largest portion of the financing will consist of debt instruments.

Financing commitments for the total amount have been received from Deutsche Bank, Credit Suisse and JP Morgan. Details of the financing plan will be published in the coming weeks. Deutsche Bank acts as Global Coordinator of the financing and as sole M&A advisor to Fresenius.

The transaction is subject to certain closing conditions, including regulatory approvals, and approvals under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Fresenius anticipates closing the transaction at the end of 2008 or beginning of 2009.

Conference Call
A conference call to inform about the acquisition will be held today at 2.30 p.m. CEDT / 8.30 a.m. EDT. All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com / Investor Relations / Presentations. A replay of the call will be available on our website shortly after the call.

EPS: before one-time transaction-related depreciation charges and assuming a 2008 closing.

Adjusted EBITDA: EBITDA before one-time expenses and stock-option expenses, as published by APP in Form 8-K, March 10, 2008, as of Dec 31, 2007.

Fresenius Kabi has successfully closed the acquisition of Dabur Pharma Ltd. In April 2008, the company had announced the acquisition of 73.3 % of the share capital for a price of INR 76.50 per share in cash. Fresenius Kabi has now acquired a further 17.6 % shareholding for a price of INR 76.50 per share in cash through a public offer. Closing of the transaction had also been subject to relevant approvals required under Indian law, which have been received.

The acquisition significantly expands Fresenus Kabi's i.v. drug portfolio and secures its supply of high quality APIs for cytostatics. Dabur Pharma, headquartered in New Delhi, is one of the leading suppliers of generic drugs and active pharmaceutical ingredients (API) to treat cancer. The company holds a substantial number of drug registrations in Asia, Europe and the US.

Dabur Pharma had consolidated revenues of about € 47 million in fiscal year 2007/2008 (April 1, 2007 to March 31, 2008).

Dabur Pharma will be consolidated as from September 1, 2008 in the financial statements of Fresenius Group.