Fresenius Kabi

Our business grew across all regions and product segments in 2018. Organic sales growth of 7% and EBIT growth in constant currency of 2% significantly exceeded original expectations.

Kabi content

We launched more than 90 generic I.V. drugs in 2018.

Fresenius Kabi specializes in the therapy and care of chronic­ally and critically ill people. The portfolio includes IV drugs, i. e., intravenously administered generic anesthetics, anal­gesics, anti-infectives, and drugs for the treatment of oncol­ogical and other critical diseases. We are also developing biosimilars with a focus on oncology and autoimmune diseases. Another product segment is clinical nutrition. In this segment, we are one of the few companies worldwide that offer both parenteral and enteral nutrition products. The infusion therapy portfolio includes infusion solutions and blood volume substitutes. In the medical devices / transfusion technology segment, we offer infusion and nutrition pumps, as well as consumables, for the administration of pharmaceuticals and clinical nutrition products. Moreover, our portfolio includes products used in the collection and processing of blood components, as well as in transfusion medicine.

Business development

Sales increased by 3% to €6,544 million in 2018. Organic sales growth was 7%. Negative currency translation effects (4%) were mainly related to the devaluation of the U.S. dollar, the Brazilian real, and the Argentinian peso against the euro.

In Europe, we achieved organic sales growth of 3% based on the good development of the clinical nutrition product segment. In North America, organic sales growth was 8%, driven by persisting IV drug shortages and new product launches. Fresenius Kabi also showed strong overall growth in the emerging markets. We achieved organic sales growth of 17% in Latin America. In Asia-Pacific we achieved organic sales growth of 12%.

Sales by region
€in millions 2018 2017 Change Currency translation effects % of total Fresenius Kabi sales
Europe 2,248 2,214 2% - 1% 34%
North America 2,359 2,290 3% - 5% 36%
Asia-Pacific 1,300 1,196 9% - 3% 20%
Latin America / Africa 637 658 - 3% - 15% 10%
Total 6,544 6,358 3% - 4% 100%
Sales by product segment were as follows:
€in millions 2018 2017 Organic
sales growth
IV drugs 2,735 2,699 5%
Clinical nutrition 1,796 1,671 13%
Infusion therapy 929 903 7%
Medical devices /
Transfusion technology
1,084 1,085 4%
Total 6,544 6,358 7%

EBIT 1 rose by 5% to €1,305 million. Currency translation had a negative effect of 5%.

1Before special items; before expenditures for further development of biosimilars business.

€in millions 2018 2017 Change
Europe 355 351 1%
North America 894 853 5%
Asia-Pacific / Latin America / Africa 398 373 7%
Administrative and ­corporate R & D expenses - 508 - 400 27%
EBIT1 1,139 1,177 - 3%
EBIT excl. biosimilars 1 1,305 1,237 5%
EBIT margin excl.
biosimilars 1
19.9% 19.5%
Net income1,2 742 702 6%

1 Before special items

2 Net income attributable to the shareholders of Fresenius SE & Co. KGaA

Acquisitions / investments

In the lawsuit by Akorn, Inc., a U.S.-based manufacturer and marketer of prescription and over-the-counter pharmaceutical products, against Fresenius for the consummation of the April 2017 merger agreement, the Supreme Court in the U.S. state of Delaware ruled in favor of Fresenius on December 7, 2018. As this is the highest Court in Delaware, no further appeal is possible (for further details please see page 67).

In the United States, we are expanding our plant in Melrose Park, near Chicago, into a state-of-the-art campus for the manufacture of intravenously administered drugs. The investment volume for this expansion amounts to approximately US$ 350 million. At our existing site in Wilson, North Carolina, we will invest approximately US$ 350 million in the construction of a new manufacturing facility.

Enteral nutrition products are Fresenius Kabi’s fastest-growing product segment. Due to strong demand, we will create additional production capacities: last year, we started to expand our plant in Wuxi, China, to produce enteral nutrition products. Production is scheduled to start in 2019. We are also expanding our production capacities in Europe, where we will invest almost €100 million in our plant in Emmer-Compascuum, Netherlands.

Product segments

In the generic IV drugs segment, we have expanded our product portfolio to additional regional markets. There were more than 90 product launches of IV drugs worldwide. In the biosimilars segment, we took an important step in the future commercialization of our biosimilar products with the conclusion of a global settlement and license agreement with AbbVie for our biosimilar candidate of AbbVie’s Humira®. Subject to regulatory approval, we will be able to market our biosimilar candidate in the United States from September 30, 2023. Fresenius Kabi expects to launch the product in Europe from the first half of 2019 onwards.

In clinical nutrition, we further expanded the market presence of our products for parenteral nutrition. With our three-chamber bags, we are the global leader in the multi-chamber bag product segment for parenteral nutrition. In 2018, we launched our new product ­SmofKabiven extra Nitrogen, a three-chamber bag with a special protein-energy ratio, in Europe. We also introduced a new product line in enteral nutrition in the year under review: Fresubin 2kcal Savoury is a high- calorie, high-protein formula that we launched in Europe and Latin America.

In infusion therapy, we launched our isotonic sodium chloride solution in the freeflex bag in the United States.

In 2018, we continued to move forward with the internationalization of our product range and we introduced new products in our medical devices / transfusion technology business segment. For example, for our new Agilia SP PCA infusion pump and our new Amika+ nutrition pump we received CE marking and started launch activities worldwide.

Please refer to pages 75 f. of the Group Management Report for the 2019 financial outlook of Fresenius Kabi. For further information, please see Fresenius Kabi’s website at www.fresenius-kabi.com.