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.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2011, Group sales were €16.5 billion. On June 30, 2012, the Fresenius Group had 161,685 employees worldwide.
For more information visit the company's website at www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
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 is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2011, Group sales were €16.5 billion. On September 30, 2012, the Fresenius Group had 163,463 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo,
Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
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 a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2011, Group sales were €16.5 billion. On September 30, 2012, the Fresenius Group had 163,463 employees worldwide.
For more information visit the company's website at www.fresenius.com.
Fresenius Kabi is focused on the therapy and care of critically and chronically ill patients inside and outside the hospital. Its portfolio comprises a wide range of IV drugs, infusion therapies, clinical nutrition products as well as the related medical devices. With a corporate philosophy of "caring for life," the company's goal is to improve the patient's quality of life. In 2011, Fresenius Kabi's sales were €3,964 million and the company's EBIT was €803 million. Fresenius Kabi has 25,521 employees worldwide (September 30, 2012).
Fresenius Kabi AG is a 100% subsidiary of the health care group Fresenius SE & Co. KGaA.
For more information visit the company's website at www.fresenius-kabi.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
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.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2012, Group sales were €19.3 billion. On March 31, 2013, the Fresenius Group had 171,764 employees worldwide.
For more information visit www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
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
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2012, Group sales were €19.3 billion. On June 30, 2013, the Fresenius Group had 173,325 employees worldwide.
For more information visit www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
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.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2012, Group sales were €19.3 billion. On June 30, 2013, the Fresenius Group had 173,325 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Fresenius Kabi has started the joint venture announced in August with the leading Indonesian pharmaceutical company PT Soho Global Health (SGH) by completing the acquisition of a 51 percent stake in PT Ethica Industri Farmasi, a subsidiary of SGH, on October 1, 2013.
The joint venture operates a production plant in Jakarta and primarily manufactures I.V. generic drugs and infusion solutions. In 2012, the product portfolio of the new joint venture generated sales of more than €40 million.
The joint venture makes Fresenius Kabi the market leader in I.V. generics in Indonesia, and provides an attractive platform for future growth in one of the fastest-growing emerging economies in Southeast Asia.
The parties agreed not to disclose the purchase price.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2012, Group sales were €19.3 billion. On June 30, 2013, the Fresenius Group had 173,325 employees worldwide.
For more information visit www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Fresenius Kabi is entering into a joint venture with Sistema JSFC, a large diversified holding company in Russia, and Zenitco Finance Management LLC. The joint venture combines Fresenius Kabi's Russian and CIS business with CJSC Binnopharm, a subsidiary of Sistema, with a minority stake owned by Zenitco. Fresenius Kabi will hold a 51 percent stake in the new company.
Binnopharm is a Russian manufacturer and distributor of I.V. drugs, infusion solutions and active pharmaceutical ingredients. Located in the Moscow area, Binnopharm has two manufacturing facilities and more than 350 employees. 2013 sales were US$104 million.
Fresenius Kabi entered the Russian market in 1994, and currently sells infusion therapies, clinical nutrition and I.V. drugs in the country. 2013 sales were US$73 million.
The joint venture is an excellent platform for further growth in Russia and the CIS states. In addition, it provides domestic manufacturing capacity.
The market for pharmaceutical products in Russia is forecast to grow from approximately €14 billion in 2013 to approximately €21 billion in 2017*.
Financial terms were not disclosed. The transaction is subject to approvals by the antitrust authorities as well as the Russian Government Commission on Monitoring Foreign Investments, and is expected to close by year-end 2014.
*IMS 2013
Fresenius is a global health care group, providing products and services for dialysis, hospital and outpatient medical care. In 2013, Group sales were €20.3 billion. On December 31, 2013, the Fresenius Group had 178,337 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Fresenius Kabi has entered into an agreement to acquire the privately held Brazilian pharmaceutical company Novafarma Indústria Farmacêutica Ltda. This transaction is part of Fresenius Kabi's strategy to expand its market presence and product portfolio in emerging markets.
Novafarma offers a comprehensive range of generic I.V. drugs, including antibiotics, analgesics and anesthetics, for the Brazilian hospital market. Founded in 1992, the company is headquartered in the state of Goiás, where it also operates a manufacturing facility and a research and development center. 2013 sales were approximately €34 million.
Fresenius Kabi entered the Brazilian market in 1977, and is one of the country's leading suppliers of clinical nutrition, infusion therapy and medical devices/transfusion technology. The acquisition significantly broadens Fresenius Kabi's generic I.V. drugs portfolio for the region, and creates an excellent platform for further growth in this product segment in other Latin American countries.
Brazil is the largest pharmaceutical market in Latin America, with 2013 sales of €14.5 billion1. In recent years, this market has grown at high single-digit to low double-digit rates. This growth trend is expected to continue in the coming years2.
"With this acquisition, we are building on our long-term market presence in Brazil and establishing a strong hub for the further expansion of our generic drug business in the Latin American region," said Mats Henriksson, CEO of Fresenius Kabi. "Novafarma's portfolio will enable us to provide patients and healthcare professionals with an extensive range of high quality and affordable I.V. generics."
Financial terms were not disclosed. The transaction is subject to antitrust approval in Brazil, and is expected to close in the second quarter of 2014.
1IMS Health, 2013, IMS Market Prognosis 2013-2017 – Latin America - Brazil
2IMS Health, 2013, Global pharma market outlook
Fresenius is a global health care group, providing products and services for dialysis, hospital and outpatient medical care. In 2013, Group sales were €20.3 billion. On March 31, 2014, the Fresenius Group had 201,924 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Fresenius Kabi and its partners Sistema JSFC and Zenitco Finance Management LLC have mutually agreed to terminate the joint venture agreement announced in April 2014. The intention was to combine Fresenius Kabi's Russian and CIS business with the partners' subsidiary CJSC Binnopharm. Changing political and regulatory circumstances in the region have made the closing of the joint venture more challenging than anticipated.
Fresenius Kabi entered the Russian market in 1994 and today provides infusion therapies, clinical nutrition and I.V. drugs. The company is committed to further grow its business in the region, and is exploring other potential options to cooperate with Binnopharm.
Fresenius is a global health care group, providing products and services for dialysis, hospital and outpatient medical care. In 2013, Group sales were €20.3 billion. On September 30, 2014, the Fresenius Group had 214,401 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
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.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Dr. Francesco De Meo, Dr. Jürgen Götz, Mats Henriksson, Rice Powell, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick