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  • Preliminary guidance for 2021 confirmed
  • Strategic roadmap for accelerated growth through 2023 and beyond
  • Group-wide initiatives to improve efficiency and profitability in preparation
  • Medium-term growth targets confirmed
  • 28th consecutive dividend increase proposed

 

If no timeframe is specified, information refers to Q4/2020 2020 and 2019 according to IFRS 16

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

Stephan Sturm, CEO of Fresenius, said:” The pandemic year 2020 showed emphatically the importance of forward-thinking, effective and efficient healthcare. Fresenius is making a vital contribution here, in many different areas of medicine. This year, the pandemic will again present us with a number of challenges, making it even more important that we increase efficiency in order to improve our cost base. Beyond our established businesses, we will also expand in important growth areas including biosimilars, digital healthcare, home dialysis and fertility medicine. By doing so, we are laying the foundations for more dynamic growth in the coming years. Even though the pandemic and its consequences are keeping us busy right now, we are already looking ahead and setting the course for the medicine of the future. In this way, we are also securing our company’s sustainable economic success.”


FY/21 Group guidance
For FY/21, Fresenius projects sales growth1 in a low to mid-single-digit percentage range and at least broadly stable net income2,3 year-over-year, both in constant currency. Implicitly, net income2 for the Group excluding Fresenius Medical Care is expected to grow in a mid-to high single digit percentage range in constant currency. Fresenius projects net debt/EBITDA4 to be around the top-end of the self-imposed target corridor of 3.0x to 3.5x by the end of FY/21.


COVID-19 assumptions for guidance FY/21
COVID-19 will continue to impact Fresenius’ operations in 2021. Current burdens and constraints caused by COVID-19 are expected to recede only in H2/21. The expected improvement in the Group’s relevant business environment from H2/21 is heavily dependent on continuously increasing levels of vaccination coverage in Fresenius’ relevant markets. These assumptions are subject to considerable uncertainty.
Fresenius closely monitors the development of COVID-19 case numbers, and the associated various containment measures being enacted in many of the Company’s relevant markets. A possible significant deterioration of the situation associated with further containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/21 guidance.

 

1 FY/20 base: €36,277 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/20 base: €1,796 million; before special items; FY/21: before special items
4 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions; before special items
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

Efficiency and cost saving programs
COVID-19 has led and will lead to a shortfall relative to our original expectations in FY/20 and FY/21 as well as to ongoing incremental uncertainty. Fresenius is hence planning to launch group-wide strategic efficiency initiatives to further safeguard the confirmed medium-term targets and sustainably enhance profitability. These initiatives are expected to consist of operational excellence and cost-saving measures, targeted strengthening of future growth areas and portfolio optimizations. The operational excellence and cost-saving measures are targeted to result in cost savings of at least €100 million p.a. after tax and minority interest in 2023 with some further potential to increase thereafter. We anticipate that achieving these sustainable efficiencies will require significant up-front expenses. On average for the years 2021 to 2023, those expenses are expected to be in the order of magnitude of €100 million p.a. after tax and minority interest. They will be classified as special items. Further information will be provided during our Q1 earnings call on May 6, 2021.


Growth targets for 2020 – 2023 confirmed
Fresenius continues to expect Group sales to grow organically with a compounded annual growth rate (CAGR) of 4% to 7% during 2020 to 2023. Group net income1,2 is projected to increase organically with a CAGR of 5% to 9% during 2020 to 2023. Fresenius expects its sales growth and efficiency improvement initiatives as well as Fresenius Kabi’s biosimilars business to drive an acceleration of Group earnings growth over that period. Small and medium-sized acquisitions are expected to contribute an incremental CAGR of approx. 1%-point to both sales and net income growth.


28th consecutive dividend increase proposed
The Management Board of Fresenius will propose to the Supervisory Board a dividend increase of 5% to €0.88 per share for FY/20 (FY/19: €0.84). Provided the proposal is approved by the Supervisory Board and the Annual General Meeting, this will be the 28th consecutive dividend increase.

 

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

5% sales growth in constant currency
Group sales remained on prior year’s level (increased by 5% in constant currency) at €9,304 million (Q4/19: €9,311 million). Organic growth was 2%. Acquisitions/ divestitures contributed net 3% to growth. Currency translation reduced sales growth by 5%. Excluding estimated COVID-19 effects1, Group sales growth would have been 7% to 8% in constant currency.
In FY/20, Group sales increased by 2% (5% in constant currency) to €36,277 million (FY/19: €35,409 million). Organic growth was 3%. Acquisitions/divestitures contributed net 2% to sales growth. Currency translation reduced sales growth by 3%. Excluding estimated COVID-19 effects1, Group sales growth would have been 7% to 8% in constant currency.


2% net income2,3 growth in constant currency
Group EBITDA before special items decreased by 3% (increased by 3% in constant currency) to €1,886 million (Q4/192: €1,937 million). Reported Group EBITDA was €1,854 million (Q4/19: €1,937 million).
In FY/20, Group EBITDA before special items remained on prior year’s level (increased by 2% in constant currency) at €7,132 million (FY/192: €7,104 million). Reported Group EBITDA was €7,100 million (FY/19: €7,083 million).


Group EBIT before special items decreased by 3% (increased by 2% in constant currency) to €1,251 million (Q4/192: €1,287 million). The constant currency increase is due to the positive development at Fresenius Medical Care and Fresenius Helios. Missing contributions from elective procedures, volume headwinds leading to underutilized production capacities, headwinds at Fresenius Kabi North America, COVID-19 related project delays at Fresenius Vamed as well as Group-wide incremental COVID-19 related expenses weighed on EBIT. The EBIT margin before special items was 13.4% (Q4/192: 13.8%). Reported Group EBIT was €1,024 million (Q4/19: €1,269 million). In FY/20, Group EBIT before special items decreased by 2% (0% in constant currency) to €4,612 million (FY/192: €4,688 million). The EBIT margin before special items was 12.7% (FY/192: 13.2%). Higher levels of investments in recent years triggered incremental depreciation charges. Reported Group EBIT was €4,385 million (FY/19: €4,631 million).


Group net interest before special items improved to -€159 million (Q4/192: -€182 million) mainly due to successful refinancing activities, lower interest rates as well as currency translation effects. Reported Group net interest improved to -€156 million (Q4/19: -€184 million).

 

1 For estimated COVID-19 effects in Q4/20 and FY/20 please see table on page 18 in the PDF document.
2 Before special items
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

In FY/20, Group net interest before special items improved to -€654 million (FY/191: - €714 million) while reported Group net interest improved to -€659 million (FY/19: -€719 million).


The Group tax rate before special items was 24.1% (Q4/191: 23.8%) and the reported Group tax rate was 29.4% (Q4/19: 23.0%). The increase is due to a not tax deductible €195 million impairment of goodwill and tradenames in the Latin America segment at Fresenius Medical Care. In FY/20, the Group tax rate before special items was 23.1% (FY/191: 23.3%) and the reported Group tax rate was 24.2% (FY/19: 22.6%).


Noncontrolling interests before special items were €335 million (Q4/191: €336 million) of which 93% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €203 million (Q4/19 reported: €320 million). In FY/20, noncontrolling interests before special items were €1,248 million (FY/191: €1,170 million) of which 96% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €1,116 million (FY/19 reported: €1,146 million).


Group net income2 before special items decreased by 2% (increased by 2% in constant currency) to €494 million (Q4/19: €506 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 3% to 7% in constant currency. Reported Group net income2 decreased to €410 million (Q4/19: €515 million). The decrease is mainly due to an impairment of goodwill and tradenames in the Latin America segment at Fresenius Medical Care and the increased valuation of the biosimilars contingent purchase price liabilities at Fresenius Kabi. In FY/20, Group net income2 before special items decreased by 4% (-3% in constant currency) to €1,796 million (FY/191: €1,879 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 2% to 6% in constant currency. Reported Group net income2 decreased to €1,707 million (FY/19: €1,883 million).


Earnings per share2 before special items decreased by 2% (increased by 2% in constant currency) to €0.88 (Q4/191: €0.90). Reported earnings per share2 were €0.73 (Q4/19: €0.92). In FY/20, earnings per share2 before special items decreased by 4% (-3% in constant currency) to €3.22 (FY/191: €3.37). Reported earnings per share2 were €3.06 (FY/191: €3.38).

 

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 For estimated COVID-19 effects in Q4/20 and FY/20 please see table on page 18 in the PDF document.
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

Continued investment in growth
Spending on property, plant and equipment was €856 million corresponding to 9% of sales (Q4/19: €871 million; 9% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics. Despite the COVID-19 pandemic, Fresenius has been largely able to continue its investment programs. In FY/20, spending on property, plant and equipment was €2,398 million corresponding to 7% of sales (FY/19: €2,463 million; 7% of sales).


Total acquisition spending was €251 million (Q4/19: €331 million). In FY/20, total acquisition spending was €902 million, mainly for the purchase of hospitals by Fresenius Helios in Germany and Colombia (FY/19: €2,623 million, mainly for the acquisition of NxStage by Fresenius Medical Care).


Good cash flow development
Group operating cash flow increased to €1,390 million (Q4/19: €1,286 million) with a margin of 14.9% (Q4/19: 13.8%). Free cash flow before acquisitions and dividends increased to €590 million (Q4/19: €442 million). Free cash flow after acquisitions and dividends increased to €329 million (Q4/19: €89 million).

In FY/20, Group operating cash flow increased to €6,549 million (FY/19: €4,263 million) with a margin of 18.1% (FY/19: 12.0%). The increase was largely driven by Fresenius Medical Care due to the U.S. federal relief funding and advanced payments under the Coronavirus Aid, Relief and Economic Security Act (CARES Act) as well as by the shorter payment periods of the COVID-19 governmental compensation and reimbursement scheme for Helios Germany. Also excluding these COVID-19 effects, Group operating cash flow would have grown year-over-year. Free cash flow before acquisitions and dividends increased to €4,183 million (FY/19: €1,830 million). Free cash flow after acquisitions and dividends increased to €2,478 million (FY/19: -€1,545 million, driven by Fresenius Medical Care’s acquisition of NxStage).


Solid balance sheet structure
Group total assets decreased by 1% (increased by 5% in constant currency) to €66,646 million (Dec. 31, 2019: €67,006 million). The decrease is mainly due to currency translation effects outweighing the expansion of business activities. Current assets increased by 3% (10% in constant currency) to €15,772 million (Dec. 31, 2019: €15,264 million), mainly driven by the increase of cash and cash equivalents. Non-current assets decreased by 2% (increased by 3% in constant currency) to €50,874 million (Dec. 31, 2019: €51,742 million).

Total shareholders’ equity decreased by 2% (increased by 6% in constant currency) to €26,023 million (Dec. 31, 2019: €26,580 million). The equity ratio was 39.0% (Dec. 31, 2019: 39.7%).


Group debt decreased by 5% (-2% in constant currency) to €25,913 million (Dec. 31, 2019: € 27,258 million). Group net debt decreased by 6% (-4% in constant currency) to € 24,076 million (Dec. 31, 2019: € 25,604 million), driven by the exceptional cash flow development.


As of December 31, 2020, the net debt/EBITDA ratio improved to 3.44x1,2 (Dec. 31, 2019: 3.61x1,2) driven by the exceptional cash flow development, despite COVID-19 effects weighing on EBITDA.

 

1 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures
2 Before special items
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Business Segments


Fresenius Medical Care (Financial data according to Fresenius Medical Care press release)
Fresenius Medical Care is the world's largest provider of products and services for individuals with renal diseases. As of December 31, 2020, Fresenius Medical Care was treating 346,553 patients in 4,092 dialysis clinics. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

  • 2020 financial targets achieved: 5% revenue and 12% net income growth
  • Reported earnings in Q4 negatively impacted by impairment in the Latin America region and accelerated excess mortality due to COVID-19
  • Growth in home dialysis on track

Sales of Fresenius Medical Care decreased by 4% (increased by 4% in constant currency) to €4,400 million (Q4/19: €4,580 million). Thus, currency translation had a negative effect of 8%. Organic growth was 1%. Acquisitions/divestitures contributed net 3% to growth. In FY/20, Fresenius Medical Care increased sales by 2% (5% in constant currency) to €17,859 million (FY/19: €17,477 million). Thus, currency translation had a negative effect of 3%. Organic growth was 3%. Acquisitions/divestitures contributed net 2% to growth.


Reported EBIT decreased by 25% (-18% in constant currency) to €462 million (Q4/19: €616 million). The decrease was mainly due to a macro-economic driven impairment of goodwill and tradenames in the Latin America segment, unfavorable COVID-19 effects and a lower reimbursement for calcimimetics. The reported EBIT margin was 10.5% (Q4/19: 13.5%). EBIT on an adjusted basis decreased by 1% (increased by 5% in constant currency) to €657 million (Q4/19: €663 million). The EBIT margin on an adjusted basis was 14.9% (Q4/19: 14.5%).


In FY/20, reported EBIT increased by 2% (4% in constant currency) to €2,304 million (FY/19: €2,270 million). The reported EBIT margin was 12.9% (FY/19: 13.0%). EBIT on an adjusted basis increased by 6% (8% in constant currency) to €2,499 million (FY/19: €2,356 million). The EBIT margin on an adjusted basis was 14.0% (FY/19: 13.5%).

 

1 Before special items
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Reported net income1 decreased by 48% (-43% in constant currency) to €177 million (Q4/19: €343 million) and increased on an adjusted basis by 1% (6% in constant currency) to €372 million (Q4/19: €368 million). In FY/20, reported net income1 decreased by 3% (-1% in constant currency) to €1,164 million (FY/19: €1,200 million) and increased on an adjusted basis by 10% (12% in constant currency) to €1,359 million (FY/19: €1,236 million).


Operating cash flow was €584 million (Q4/19: €771 million) with a margin of 13.3% (Q4/19: 16.8%). In FY/20, operating cash flow was €4,233 million (FY/19: €2,567 million) with a margin of 23.7% (FY/19: 14.7%). The increase was largely driven by the U.S. federal relief funding and advanced payments under the CARES Act and other COVID-19 relief, as well as working capital improvements driven by cash collections.


For FY/21, Fresenius Medical Care expects revenue2 to grow at a low- to mid-single digit percentage range and net income1,3 to decline at a high-teens to mid-twenties percentage range against the higher than expected 2020 base4.


For further information, also on the FME25 program, please see Fresenius Medical Care’s press release at www.freseniusmedicalcare.com.

 

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 FY/20 base: €17,859 million
3 FY/20 base: €1,359 million, before special items; FY/21: before special items
4 These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of €195 million. They are inclusive of anticipated COVID-19 effects, in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Fresenius Kabi
Fresenius Kabi offers intravenously administered generic drugs, clinical nutrition and infusion therapies for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products. In the biosimilars business, Fresenius Kabi develops products with a focus on oncology and autoimmune diseases.

  • In North America fewer elective treatments, competitive pressure and temporary manufacturing issues outweighed extra demand for COVID-19 related products
  • Europe showed strong organic sales growth in Q4 primarily based on extra demand for COVID-19 related products; China with healthy organic growth
  • Strong EBIT growth in Emerging Markets with positive development in China only partially compensates EBIT decrease in North America

 

Sales increased by 3% (8% in constant currency) to €1,815 million (Q4/19: €1,766 million). Organic growth was 7%. Negative currency translation effects of 5% were mainly related to weakness of the US dollar, the Brazilian real and the Argentinian peso. Estimated COVID-19 effects made a slight positive contribution to sales growth. In FY/20, sales increased by 1% (4% in constant currency) to €6,976 million (FY/19: €6,919 million). Organic growth was 4%. Negative currency translation effects of 3% were mainly related to the weakness of the US dollar, the Brazilian real and the Argentinian peso. Estimated COVID-19 effects slightly reduced sales growth.


Sales in North America decreased by 10% (organic growth: -3%) to €549 million (Q4/19: €609 million). The decrease was driven by fewer elective treatments, supply constraints for certain products due to temporary manufacturing issues and competitive pressure, which outweighed extra demand for COVID-19 related products. In FY/20, sales in North America decreased by 2% (organic growth: 0%) to €2,376 million (FY/19: €2,424 million). Sales in Europe increased by 13% (organic growth: 9%) to €680 million (Q4/19: €604 million) mainly due to increased demand for COVID-19 related products. In FY/20, sales in Europe increased by 6% (organic growth: 6%) to €2,458 million (FY/19: €2,313 million). Sales in Asia-Pacific increased by 11% (organic growth: 14%) to €428 million (Q4/19: €385 million). While China saw a solid recovery based on increasing elective procedures, other Asian markets were lagging behind. In FY/20, sales in Asia-Pacific decreased by 1% (organic growth: 1%) to €1,497 million (FY/19: €1,506 million). Sales in Latin America/Africa decreased by 6% (organic growth: 16%) to €158 million (Q4/19: €168 million). In FY/20, sales in Latin America/Africa decreased by 5% (organic growth: 17%) to €645 million (FY/19: €676 million).

 

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

EBIT before special items decreased by 17% (-10% in constant currency) to €236 million (Q4/191: €285 million) with an EBIT margin before special items of 13.0% (Q4/191:16.1%). The decline is driven by headwinds leading to some underutilized production capacities in the US, coupled with selective supply constraints due to temporary manufacturing issues, incremental COVID-19 related expenses, competitive pressure, a negative effect due to the bankruptcy of a customer as well as planned SG&A spending ahead of the launch of the company’s first US biosimilar. Lower corporate costs due to travel restrictions and phasing of projects partially offset the decline. Estimated COVID-19 effects had a moderate negative impact on EBIT growth in Q4/20. In FY/20, EBIT before special items decreased by 9% (-6% in constant currency) to €1,095 million (FY/191: €1,205 million) with an EBIT margin before special items of 15.7% (FY/191: 17.4%). Estimated COVID-19 effects had an insignificant impact on EBIT growth in FY/20.


Net income1,2 decreased by 19% (-11% in constant currency) to €148 million (Q4/191: €183 million). In FY/20, net income1,2 decreased by 8% (-5% in constant currency) to €730 million (FY/191: €797 million).


Operating cash flow increased to €307 million (Q4/19: €291 million) with a margin of 16.9% (Q4/19: 16.5%). In FY/20, operating cash flow increased by 11% to €1,143 million (FY/19: €1,028 million) with a margin of 16.4% (FY/19: 14.9%) due to the favorable working capital development.


For FY/21, Fresenius Kabi expects organic sales3 growth in a low to mid-single digit percentage range. Constant currency EBIT4 is expected to show a stable development up to low single digit percentage growth. Both sales and EBIT outlook include expected COVID-19 effects.

 

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/20 base: €6,976 million
4 FY/20 base: €1,095 million, before special items, FY/21: before special items
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Fresenius Helios
Fresenius Helios is Europe's leading private hospital operator. The company comprises Helios Germany and Helios Spain (Quirónsalud). Helios Germany operates 89 hospitals, ~130 outpatient centers and 6 prevention centers. Quirónsalud operates 46 hospitals, 70 outpatient centers and around 300 occupational risk prevention centers. In addition, the company is active in Latin America with 6 hospitals and as a provider of medical diagnostics.

  • Recovery of elective procedures in Spain in Q4
  • Continued financial support provided by German government throughout Q4
  • Helios Spain with strong organic sales and EBIT growth based on catch-up effects additionally fueled by contributions from acquisitions in Latin America

 

Sales increased by 13% (13% in constant currency) to €2,637 million (Q4/19: €2,344 million). Organic growth was 9%. Acquisitions contributed 4% to sales growth. COVID-19 effects had an insignificant effect on organic growth. In FY/20, sales increased by 6% (7% in constant currency) to €9,818 million (FY/19: €9,234 million). Organic growth was 4%. Acquisitions contributed 3% to sales growth. COVID-19 effects had a slight negative impact on organic growth.


Sales of Helios Germany increased by 11% (organic growth: 8%) to €1,637 million (Q4/19: €1,475 million). In FY/20, sales of Helios Germany increased by 7% (organic growth: 6%) to €6,340 million (FY/19: €5,940 million). COVID-19 effects were mitigated by government financial support and hence had only a slight negative impact on organic growth in both Q4/20 and FY/20.


Sales of Helios Spain increased by 15% (17% in constant currency) to €999 million (Q4/19: €867 million). Organic growth of 11% was driven by a strong recovery of elective procedures and a consistently high level of outpatient treatments. Thus, COVID-19 effects had a moderate positive impact on organic growth in Q4. The hospital acquisitions in Colombia contributed 6% to sales growth. In FY/20, sales of Helios Spain increased by 6% (7% in constant currency) to €3,475 million (FY/19: €3,292 million). Organic growth was 2%. Acquisitions contributed 5% to sales growth. COVID-19 effects had a significant negative impact on organic sales growth.

 

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

 

EBIT of Fresenius Helios increased by 12% (13% in constant currency) to €328 million (Q4/19: €294 million) with an EBIT margin of 12.4% (Q4/19: 12.5%). COVID-19 effects, in particular due to the strong recovery of elective procedures in Spain, had a significant positive effect on EBIT growth in Q4. In FY/20, EBIT of Fresenius Helios remained on prior year’s level (0% in constant currency) at €1,025 million (FY/19: €1,025 million) with an EBIT margin of 10.4% (FY/19: 11.1%). COVID-19 effects had a moderate negative impact on EBIT growth.


EBIT of Helios Germany increased by 10% to €157 million (Q4/19: €143 million) with an EBIT margin of 9.6% (Q4/19: 9.7%). Financial support provided by the German government under revised regulations focusing on regions with high COVID incidences broadly offset additional headwinds as Helios Germany continued to play a crucial role in treating COVID-19 patients. In FY/20, EBIT of Helios Germany increased by 4% to €602 million (FY/19: €577 million) with an EBIT margin of 9.5% (FY/19: 9.7%). Due to the comprehensive financial support provided by the German government, COVID-19 effects had an overall insignificant impact on the EBIT development.


EBIT of Helios Spain increased by 17% (19% in constant currency) to €159 million (Q4/19: €136 million) with an EBIT margin of 15.9% (Q4/19: 15.7%). The growth is driven by a recovery of elective procedures following the government-ordered postponement of planned surgical procedures in Q2, where medically justifiable. Thus, COVID-19 effects had a significant positive effect on EBIT growth in Q4. In FY/20, EBIT of Helios Spain decreased by 5% (-5% in constant currency) to €420 million (FY/19: €443 million) with an EBIT margin of 12.1% (FY/19: 13.5%). COVID-19 effects had a very significant negative impact on EBIT growth with missing or delayed elective procedures and higher expenses amid the comprehensive efforts to combat the pandemic.


Net income1 increased by 14% to €225 million (Q4/19: €197 million). In FY/20, net income1 remained on prior year’s level at €666 million (FY/19: €664 million).


Operating cash flow increased to €434 million (Q4/19: €226 million) with a margin of 16.5% (Q4/19: 9.6%), driven by phasing of payments under the German law to ease the financial burden on hospitals. In FY/20, operating cash flow increased to €1,149 million (FY/19: €733 million) with a margin of 11.7% (FY/19: 7.9%).

 

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

 

For FY/21, Fresenius Helios expects organic sales1 growth in a low to mid-single digit percentage range and constant currency EBIT2 growth in a mid to high single digit percentage range. Both sales and EBIT outlook include expected COVID-19 effects.

 

1 FY/20 base: €9,818 million
2 FY/20 base: €1,025 million; FY/21 before special items

 

Fresenius Vamed
Fresenius Vamed manages projects and provides services for hospitals and other health care facilities worldwide and is a leading post-acute care provider in Central Europe. The portfolio ranges along the entire value chain: from project development, planning, and turnkey construction, via maintenance and technical management to total operational management.

  • Significant COVID-19 impact in the project business related to delays, cancellations and global supply chain restraints continued
  • Good order intake in Q4 indicates first signs of recovery in project business
  • Rehabilitation business continued to be impacted by less demand for rehabilitation treatments and postponements of elective surgeries; technical service business remained robust

 

Sales decreased by 22% (-22% in constant currency) to €577 million (Q4/19: €737 million). Organic growth was -22%. Acquisitions did not contribute to growth. Estimated COVID-19 effects had a very significant negative impact on growth. In FY/20, sales decreased by 6% (-6% in constant currency) to €2,068 million (FY/19: €2,206 million). Organic growth was -8%. Acquisitions contributed 2% to growth. Estimated COVID-19 effects had a very significant negative impact on growth.


Sales in the service business decreased by 1% to €372 million (Q4/19: €374 million).
Sales in the project business decreased by 44% to €205 million (Q4/19: €363 million), driven by postponements and cancellations of projects. In FY/20, sales in the service business grew by 3% to €1,435 million (FY/19: €1,399 million). Sales in the project business decreased by 22% to €633 million (FY/19: €807 million).

 

1 Net income attributable to shareholders of VAMED AG

 

EBIT decreased by 42% (-42% in constant currency) to €39 million (Q4/19: €67 million) with an EBIT margin of 6.8% (Q4/19: 9.1%). Estimated COVID-19 effects had a very significant negative impact on EBIT. Capacities in the post-acute care clinics were left partially empty given a generally lower intake of elective surgery patients from acute-care hospitals. Authority-instigated restrictions or even closures of individual facilities also had a negative effect. In the project business, project delays and global supply chain restraints triggered incremental expenses. In FY/20, EBIT decreased by 78% (-79% in constant currency) to €29 million (FY/19: €134 million) with an EBIT margin of 1.4% (FY/19: 6.1%). Estimated COVID-19 effects had a very significant negative impact on EBIT.


Net income1 decreased to €25 million (Q4/19: €44 million). In FY/20, net income1 decreased to €2 million (FY/19: €83 million).


Order intake was €648 million in Q4/20 (Q4/19: €576 million) and €1,010 million in FY/20 (FY/19: €1,314 million). As of December 31, 2020, order backlog was at €3,055 million (December 31, 2019: €2,865 million). Order intake and order backlog were marked by COVID-19 related cancellations and project delays.


Operating cash flow increased to €74 million (Q4/19: €0 million) with a margin of 12.8% (Q4/19: 0%), driven by a favorable working capital development mainly related to pre-payments. In FY/20, operating cash flow increased to €78 million (FY/19: -€17 million) with a margin of 3.8% (FY/19: -0.8%).


For FY/21, Fresenius Vamed expects organic sales2 growth in a mid to high single digit percentage range and EBIT3 to grow to a high double-digit euro million amount. Both sales and EBIT outlook include expected negative COVID-19 effects.

 

1 Net income attributable to shareholders of VAMED AG
2 FY/20 base: €2,068 million
3 FY/20 base: €29 million; FY/21 before special items

 

Conference Call
As part of the publication of the results for FY 2020, a conference call will be held on February 23, 2021 at 1:30 p.m. CET (7:30 a.m. EST). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

For additional information on the performance indicators used please refer to our website https://www.fresenius.com/alternative-performance-measures.

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.

  • 2020 financial targets achieved: 5% revenue and 12% net income growth
  • Reported earnings in Q4 negatively impacted by impairment in the Latin America region and accelerated excess mortality due to COVID-19
  • Growth in home dialysis on track
  • 24th consecutive dividend increase planned to be proposed
  • FME25 – transforming global operating model to sustainably reduce cost

Rice Powell, Chief Executive Officer of Fresenius Medical Care, said: “The COVID-19 pandemic might be the most decisive challenge the world has faced in recent decades. I am incredibly proud of our employees and their tireless efforts to provide our patients with their life-sustaining treatments. Accelerated infection rates at the end of 2020 resulted in significant excess mortality in the dialysis patient population and this is expected to continue into 2021. What saddens me deeply is the human tragedy – when people we have cared for are dying. With an increasing number of vaccines being approved, there is a way out of the pandemic, but it is far from over. By using all our levers, further driving our efficiency measures and with governmental support, we managed to almost compensate the financial effects of COVID-19 in 2020. But the effects of the recent significant increase in cases and subsequent excess mortality cannot be compensated and will affect our earnings development in 2021. To overcome the impact on our 2025 growth ambitions, we have decided to launch a material transformation of our global operating model while executing on our mid-term strategy.”

FME FY20 Key figures

COVID-19 pandemic affects business development
While the pandemic has not sustainably affected the fundamental development in the number of new patients starting dialysis, excess mortality of dialysis patients significantly accelerated in the U.S. and in EMEA, particularly in November and December 2020, and accumulated to approximately 10,000 patients over the pre-pandemic baseline.

In order to maintain safe operations in its more than 4,000 dialysis centers and 44 manufacturing sites, Fresenius Medical Care has taken comprehensive measures, including the provision of personal protective equipment for employees and patients as well as higher compensation for employees working in isolation clinics. These measures have resulted in significantly increased costs in the Dialysis Services business, which in 2020 was largely compensated by governmental support, in particular in the U.S., accelerated efficiency measures and a strong products business development.

Growth in home dialysis continued
In 2020, Fresenius Medical Care provided more than 14% of its dialysis treatments in the U.S. in a home setting. This implies a 14% increase in the number of home treatments compared to the previous year, with home hemodialysis growing at 37%.

Dividend increase in line with sustainable distribution policy
Based on the strong results for 2020 and in line with the Company’s dividend policy, it is planned to propose a dividend of EUR 1.34 per share to the Annual General Meeting in May 2021. This proposal would result in the 24th consecutive dividend increase.

FME25: Transforming global operating model to strengthen profitability
To support its 2025 strategy, further strengthen profitability and compensate for the negative earnings effects of the COVID-19 pandemic, Fresenius Medical Care will launch the FME25 program. The program will focus on the simplification of the Fresenius Medical Care operating model. This shall include streamlining and transforming the Company’s global operating model, applying learnings from the “new normal” and accelerating the digitalization agenda. Until 2025 the Company plans to invest up to EUR 500 million in FME25 to sustainably reduce the cost base. The Company expects for each euro invested in FME25 to sustainably reduce the annual cost and minimally improve operating income by the same amount by 2025.3

2021 targets and assumptions
Excess mortality of dialysis patients due to the COVID-19 pandemic is continuing in 2021 and is expected to have a significant adverse effect on treatment volumes and additional COVID-19 related costs. This additionally affects the utilization of Fresenius Medical Care’s clinic network and thereby limits the ability to mitigate fixed cost and wage inflation.

Against this backdrop, Fresenius Medical Care expects revenue to grow at a low- to mid-single digit percentage rate and net income to decline at a high-teens to mid-twenties percentage rate against the higher than expected 2020 base.4

These targets are based on the following assumptions:

  • Excess mortality is expected to continue to accumulate for the first half of 2021, depending on the adoption and speed of the roll-out of vaccinations of our worldwide patient population.
  • COVID-19-related additional costs, such as costs for personal protective equipment or increased personnel costs in the Dialysis Services business, are assumed to remain on a high level.
  • Besides the extended suspension of the U.S. Medicare sequestration (until end of March 2021), no further public relief funding is assumed.

2025 targets confirmed
Fresenius Medical Care confirms its 2025 targets that are based on the Company’s mid-term strategy. Fresenius Medical Care assumes that FME25 compensates for the anticipated COVID-19-related effects. Until 2025 the company expects compounded annual average increases in the mid-single-digit percentage range for revenue and in the high-single-digit percentage range for net income.5

Robust earnings growth in FY 2020 despite COVID-19 pandemic
Due to a sizable headwind from exchange rates, revenue declined by 4% in the fourth quarter and amounted to EUR 4,400 million (+4% at constant currency). Organic growth of 1% was realized including the expected negative impacts from lower reimbursement for calcimimetics (“calcimimetics effect”) and COVID-19-related slower treatment growth.

Health Care Services revenue decreased by 6% to EUR 3,406 million (+2% at constant currency). This was only partially offset by the positive development in the Products business. Driven by strong organic growth, Health Care Products revenue grew by 2% to EUR 994 million (+9% at constant currency).

In the full year, revenue increased by 2% to EUR 17,859 million (+5% at constant currency), with organic growth of 3%. Health Care Services revenue grew by 2% to EUR 14,114 million (+5% at constant currency). This was mainly driven by organic growth of 3%, which was achieved despite the above-mentioned calcimimetics effect. Health Care Products revenue increased by 4% to EUR 3,745 million (+7% at constant currency). Important drivers were sales of products for acute care treatments and in-center disposables.

Operating income declined by 25% to EUR 462 million (-18% at constant currency), resulting in a margin of 10.5% (Q4 2019: 13.5%). This decrease was mainly due to a macro-economically driven impairment of goodwill and trade names in the Latin America segment, unfavorable COVID-19 effects and a lower reimbursement for calcimimetics. Excluding the Latin America impairment and on an adjusted 2019 basis6, operating income decreased by 1% to EUR 657 million (+5% at constant currency), resulting in a margin of 14.9% (Q4 2019: 14.5%).

In the full year, operating income grew by 2% to EUR 2,270 million (+4% at constant currency), resulting in a margin of 12.9% (FY 2019: 13.0%). Excluding the Latin America impairment and on an adjusted 2019 basis, operating income increased by 6% to EUR 2,499 million (+8% at constant currency) resulting in a margin of 14.0% (FY 2019: 13.5%).

Net income1 declined by 48% to EUR 177 million (-43% at constant currency); basic earnings per share (EPS) decreased by 47% to EUR 0.61 (-42% at constant currency). Excluding the Latin America impairment and on an adjusted 2019 basis, net income grew by 1% to EUR 372 million (+6% at constant currency). The resulting increase in EPS by 3% to EUR 1.27 (+8% at constant currency) was also supported by the Company’s completed share buyback program.

In the full year, net income declined by 3% to EUR 1,164 million (-1% at constant currency). EPS remained stable at EUR 3.96 (+2% at constant currency). Excluding the Latin America impairment and on an adjusted 2019 basis, net income grew by 10% to EUR 1,359 million (+12% at constant currency), resulting in a 13% increase in EPS to EUR 4.62 (+15% at constant currency).

Strong operational cash-flow development in FY 2020
Fresenius Medical Care generated EUR 584 million of operating cash flow (Q4 2019: EUR 771 million), resulting in a margin of 13.3% (Q4 2019: 16.8%). In the full year, operating cash flow increased to EUR 4,233 million (FY 2019: EUR 2,567 million). In addition to the strong underlying performance, this increase was supported by the U.S. federal relief funding and advanced payments under the CARES Act as well as other COVID-19 relief, including lower tax payments in the U.S. This was partially offset by an increase in inventory levels.

Free cash flow7 amounted to EUR 283 million (Q4 2019: EUR 434 million), resulting in a margin of 6.4% (Q4 2019: 9.5%). In the full year, the Company generated a free cash flow of EUR 3,197 million (FY 2019: EUR 1,454 million).

Regional developments
In North America, revenue declined by 6% to EUR 2,983 million (+2% at constant currency), mainly due to a sizable negative exchange rate effect and a substantial negative impact of COVID-19 on the Services business, resulting in organic growth of -1%. This was only partially offset by the negative prior-year effect resulting from a revenue adjustment for accounts receivable in legal dispute as well as higher sales of products for acute care treatments, renal pharmaceuticals and PD products. In the full year, North America revenue increased by 2% to EUR 12,478 million (+4% at constant currency, +2% organic).

Despite the mentioned headwinds from exchange rates, operating income in North America grew by 3% to EUR 533 million (+11% at constant currency), resulting in a margin of 17.9% (Q4 2019: 16.2%). The margin increase was mainly driven by negative prior-year earnings effects and higher reimbursement rates, partially offset by the unfavorable impact of the COVID-19 pandemic and the calcimimetics effect. In the full year, operating income rose by 18% to EUR 2,120 million (+20% at constant currency), resulting in a margin of 17.0% (FY 2019: 14.7%).

Revenue in EMEA grew by 1% and amounted to EUR 715 million (+7% at constant currency, +5% organic). Higher sales of in-center disposables as well as products for acute treatments and home hemodialysis were largely offset by a negative exchange rate effect and the impact of COVID-19 on the Services business. In the full year, EMEA revenue increased by 3% to EUR 2,763 million (+5% at constant currency, +4% organic).

Operating income in the EMEA region rose by 17% to EUR 134 million (+22% at constant currency), resulting in a margin of 18.7% (Q4 2019: 16.1%). The margin increase was mainly driven by a favorable impact from equity method investees. This was partially offset by unfavorable currency transaction effects. In the full year, operating income declined by 8% to EUR 412 million (-6% at constant currency), resulting in a margin of 14.9% (FY 2019: 16.6%).

In Asia-Pacific, revenue increased by 4% to EUR 517 million despite a negative exchange rate effect (+7% at constant currency, +8% organic). This was mainly driven by organic growth in the Services business as well as higher sales of products for acute treatments, in-center disposables and PD products. In the full year, revenue grew by 2% to EUR 1,894 million (+3% at constant currency, +4% organic). Organic growth in the Services business as well as higher sales of products for acute care treatments and in-center disposables were largely offset by the effect of closed or sold clinics.

Operating income grew by 43% to EUR 107 million (+45% at constant currency), resulting in a margin of 20.6% (Q4 2019: 15.0%). The increase in margin was mainly driven by favorable Product business growth in China and cost optimization measures. In the full year, operating income rose by 4% to EUR 344 million (+5% at constant currency), resulting in a margin of 18.1% (FY 2019: 17.7%).

Including a very significant headwind from exchange rates, Latin America revenue declined by 9% to EUR 177 million (+16% at constant currency, +9% organic). In the full year, revenue decreased by 3% to EUR 684 million (+21% at constant currency, +15% organic).

Operating income in Latin America was heavily impacted by the impairment of goodwill and trade names as a result of a macro-economic downturn and increasing risk adjustment rates for certain countries. It amounted to EUR -186 million. Excluding the impairment, operating income declined by 39% to EUR 9 million (-40% at constant currency), resulting in a margin of 5.1% (Q4: 2019: 7.6%). Operating income for the full year amounted to EUR -157 million. Excluding the impairment, operating income decreased by 11% to EUR 38 million (-2% at constant currency), resulting in a margin of 5.5% (FY 2019: 6.0%).

Patients, Clinics and Employees
As of December 31, 2020, Fresenius Medical Care treated 346,553 patients in 4,092 dialysis clinics worldwide. At the end of the year, the Company had 125,364 employees (full-time equivalents) worldwide, compared to 120,659 employees as of December 31, 2019.

Press conference
Fresenius Medical Care will hold a virtual press conference to discuss the results of the fourth quarter and full year 2020 on February 23, 2021 at 12:00 p.m. CET / 6:00 a.m. ET. The press conference will be webcasted on the Company’s website www.freseniusmedicalcare.com in the “Media” section. A replay will be available shortly after the conference.

Conference call
Fresenius Medical Care will host a conference call to discuss the results of the fourth quarter and full year 2020 on February 23, 2021 at 3:30 p.m. CET / 9:30 a.m. ET. Details will be available on the company’s website www.freseniusmedicalcare.com in the “Investors” section. A replay will be available shortly after the call.

1Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2Special item: impairment of goodwill and trade names in the Latin America Segment; for a reconciliation of 2020 figures excluding special items and 2019 adjusted figures, please refer to the table at the end of the press release
3Cost in association with FME25 will be treated as a special item.
4These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of EUR 195 million. They are inclusive of anticipated COVID-19 effects, in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
5These targets are in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
6Please see the table at the end of the press release for a detailed reconciliation
7Net cash used in operating activities, after capital expenditures, before acquisitions, investments and dividends

This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

  • Preliminary guidance for 2021 confirmed
  • Strategic roadmap for accelerated growth through 2023 and beyond
  • Group-wide initiatives to improve efficiency and profitability in preparation
  • Medium-term growth targets confirmed
  • 28th consecutive dividend increase proposed

If no timeframe is specified, information refers to Q4/2020. 2020 and 2019 according to IFRS 16

FSE FY20 Table

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA

Stephan Sturm, CEO of Fresenius, said: ”The pandemic year 2020 showed emphatically the importance of forward-thinking, effective and efficient healthcare. Fresenius is making a vital contribution here, in many different areas of medicine. This year, the pandemic will again present us with a number of challenges, making it even more important that we increase efficiency in order to improve our cost base. Beyond our established businesses, we will also expand in important growth areas including biosimilars, digital healthcare, home dialysis and fertility medicine. By doing so, we are laying the foundations for more dynamic growth in the coming years. Even though the pandemic and its consequences are keeping us busy right now, we are already looking ahead and setting the course for the medicine of the future. In this way, we are also securing our company’s sustainable economic success.”


FY/21 Group guidance
For FY/21, Fresenius projects sales growth1 in a low to mid-single-digit percentage range and at least broadly stable net income2,3 year-over-year, both in constant currency. Implicitly, net income2 for the Group excluding Fresenius Medical Care is expected to grow in a mid-to high single digit percentage range in constant currency. Fresenius projects net debt/EBITDA4 to be around the top-end of the self-imposed target corridor of 3.0x to 3.5x by the end of FY/21.


COVID-19 assumptions for guidance FY/21
COVID-19 will continue to impact Fresenius’ operations in 2021. Current burdens and constraints caused by COVID-19 are expected to recede only in H2/21. The expected improvement in the Group’s relevant business environment from H2/21 is heavily dependent on continuously increasing levels of vaccination coverage in Fresenius’ relevant markets. These assumptions are subject to considerable uncertainty.
Fresenius closely monitors the development of COVID-19 case numbers, and the associated various containment measures being enacted in many of the Company’s relevant markets. A possible significant deterioration of the situation associated with further containment measures that could have a significant and direct impact on the health care sector without any appropriate compensation is not reflected in the Group’s FY/21 guidance.

 

1 FY/20 base: €36,277 million
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/20 base: €1,796 million; before special items; FY/21: before special items
4 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions; before special items
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

Efficiency and cost saving programs
COVID-19 has led and will lead to a shortfall relative to our original expectations in FY/20 and FY/21 as well as to ongoing incremental uncertainty. Fresenius is hence planning to launch group-wide strategic efficiency initiatives to further safeguard the confirmed medium-term targets and sustainably enhance profitability. These initiatives are expected to consist of operational excellence and cost-saving measures, targeted strengthening of future growth areas and portfolio optimizations. The operational excellence and cost-saving measures are targeted to result in cost savings of at least €100 million p.a. after tax and minority interest in 2023 with some further potential to increase thereafter. We anticipate that achieving these sustainable efficiencies will require significant up-front expenses. On average for the years 2021 to 2023, those expenses are expected to be in the order of magnitude of €100 million p.a. after tax and minority interest. They will be classified as special items. Further information will be provided during our Q1 earnings call on May 6, 2021.


Growth targets for 2020 – 2023 confirmed
Fresenius continues to expect Group sales to grow organically with a compounded annual growth rate (CAGR) of 4% to 7% during 2020 to 2023. Group net income1,2 is projected to increase organically with a CAGR of 5% to 9% during 2020 to 2023. Fresenius expects its sales growth and efficiency improvement initiatives as well as Fresenius Kabi’s biosimilars business to drive an acceleration of Group earnings growth over that period. Small and medium-sized acquisitions are expected to contribute an incremental CAGR of approx. 1%-point to both sales and net income growth.


28th consecutive dividend increase proposed
The Management Board of Fresenius will propose to the Supervisory Board a dividend increase of 5% to €0.88 per share for FY/20 (FY/19: €0.84). Provided the proposal is approved by the Supervisory Board and the Annual General Meeting, this will be the 28th consecutive dividend increase.

 

1 Net income attributable to shareholders of Fresenius SE & Co. KGaA
2 Before special items
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

5% sales growth in constant currency
Group sales remained on prior year’s level (increased by 5% in constant currency) at €9,304 million (Q4/19: €9,311 million). Organic growth was 2%. Acquisitions/ divestitures contributed net 3% to growth. Currency translation reduced sales growth by 5%. Excluding estimated COVID-19 effects1, Group sales growth would have been 7% to 8% in constant currency. In FY/20, Group sales increased by 2% (5% in constant currency) to €36,277 million (FY/19: €35,409 million). Organic growth was 3%. Acquisitions/divestitures contributed net 2% to sales growth. Currency translation reduced sales growth by 3%. Excluding estimated COVID-19 effects1, Group sales growth would have been 7% to 8% in constant currency.


2% net income2,3 growth in constant currency
Group EBITDA before special items decreased by 3% (increased by 3% in constant currency) to €1,886 million (Q4/192: €1,937 million). Reported Group EBITDA was €1,854 million (Q4/19: €1,937 million). In FY/20, Group EBITDA before special items remained on prior year’s level (increased by 2% in constant currency) at €7,132 million (FY/192: €7,104 million). Reported Group EBITDA was €7,100 million (FY/19: €7,083 million).


Group EBIT before special items decreased by 3% (increased by 2% in constant currency) to €1,251 million (Q4/192: €1,287 million). The constant currency increase is due to the positive development at Fresenius Medical Care and Fresenius Helios. Missing contributions from elective procedures, volume headwinds leading to underutilized production capacities, headwinds at Fresenius Kabi North America, COVID-19 related project delays at Fresenius Vamed as well as Group-wide incremental COVID-19 related expenses weighed on EBIT. The EBIT margin before special items was 13.4% (Q4/192: 13.8%). Reported Group EBIT was €1,024 million (Q4/19: €1,269 million). In FY/20, Group EBIT before special items decreased by 2% (0% in constant currency) to €4,612 million (FY/192: €4,688 million). The EBIT margin before special items was 12.7% (FY/192: 13.2%). Higher levels of investments in recent years triggered incremental depreciation charges. Reported Group EBIT was €4,385 million (FY/19: €4,631 million).


Group net interest before special items improved to -€159 million (Q4/192: -€182 million) mainly due to successful refinancing activities, lower interest rates as well as currency translation effects. Reported Group net interest improved to -€156 million (Q4/19: -€184 million).

 

1 For estimated COVID-19 effects in Q4/20 and FY/20 please see table on page 18 in the PDF document.
2 Before special items
3 Net income attributable to shareholders of Fresenius SE & Co. KGaA
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

In FY/20, Group net interest before special items improved to -€654 million (FY/191: - €714 million) while reported Group net interest improved to -€659 million (FY/19: -€719 million).


The Group tax rate before special items was 24.1% (Q4/191: 23.8%) and the reported Group tax rate was 29.4% (Q4/19: 23.0%). The increase is due to a not tax deductible €195 million impairment of goodwill and tradenames in the Latin America segment at Fresenius Medical Care. In FY/20, the Group tax rate before special items was 23.1% (FY/191: 23.3%) and the reported Group tax rate was 24.2% (FY/19: 22.6%).


Noncontrolling interests before special items were €335 million (Q4/191: €336 million) of which 93% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €203 million (Q4/19 reported: €320 million). In FY/20, noncontrolling interests before special items were €1,248 million (FY/191: €1,170 million) of which 96% were attributable to the noncontrolling interests in Fresenius Medical Care. Reported noncontrolling interests were €1,116 million (FY/19 reported: €1,146 million).


Group net income2 before special items decreased by 2% (increased by 2% in constant currency) to €494 million (Q4/19: €506 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 3% to 7% in constant currency. Reported Group net income2 decreased to €410 million (Q4/19: €515 million). The decrease is mainly due to an impairment of goodwill and tradenames in the Latin America segment at Fresenius Medical Care and the increased valuation of the biosimilars contingent purchase price liabilities at Fresenius Kabi. In FY/20, Group net income2 before special items decreased by 4% (-3% in constant currency) to €1,796 million (FY/191: €1,879 million). Excluding estimated COVID-19 effects3, Group net income2 before special items would have grown 2% to 6% in constant currency. Reported Group net income2 decreased to €1,707 million (FY/19: €1,883 million).


Earnings per share2 before special items decreased by 2% (increased by 2% in constant currency) to €0.88 (Q4/191: €0.90). Reported earnings per share2 were €0.73 (Q4/19: €0.92). In FY/20, earnings per share2 before special items decreased by 4% (-3% in constant currency) to €3.22 (FY/191: €3.37). Reported earnings per share2 were €3.06 (FY/191: €3.38).

 

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 For estimated COVID-19 effects in Q4/20 and FY/20 please see table on page 18 in the PDF document.
For a detailed overview of special items please see the reconciliation tables in the PDF document.

 

Continued investment in growth
Spending on property, plant and equipment was €856 million corresponding to 9% of sales (Q4/19: €871 million; 9% of sales). These investments served primarily for the modernization and expansion of dialysis clinics, production facilities as well as hospitals and day clinics. Despite the COVID-19 pandemic, Fresenius has been largely able to continue its investment programs. In FY/20, spending on property, plant and equipment was €2,398 million corresponding to 7% of sales (FY/19: €2,463 million; 7% of sales).


Total acquisition spending was €251 million (Q4/19: €331 million). In FY/20, total acquisition spending was €902 million, mainly for the purchase of hospitals by Fresenius Helios in Germany and Colombia (FY/19: €2,623 million, mainly for the acquisition of NxStage by Fresenius Medical Care).


Good cash flow development
Group operating cash flow increased to €1,390 million (Q4/19: €1,286 million) with a margin of 14.9% (Q4/19: 13.8%). Free cash flow before acquisitions and dividends increased to €590 million (Q4/19: €442 million). Free cash flow after acquisitions and dividends increased to €329 million (Q4/19: €89 million).

In FY/20, Group operating cash flow increased to €6,549 million (FY/19: €4,263 million) with a margin of 18.1% (FY/19: 12.0%). The increase was largely driven by Fresenius Medical Care due to the U.S. federal relief funding and advanced payments under the Coronavirus Aid, Relief and Economic Security Act (CARES Act) as well as by the shorter payment periods of the COVID-19 governmental compensation and reimbursement scheme for Helios Germany. Also excluding these COVID-19 effects, Group operating cash flow would have grown year-over-year. Free cash flow before acquisitions and dividends increased to €4,183 million (FY/19: €1,830 million). Free cash flow after acquisitions and dividends increased to €2,478 million (FY/19: -€1,545 million, driven by Fresenius Medical Care’s acquisition of NxStage).


Solid balance sheet structure
Group total assets decreased by 1% (increased by 5% in constant currency) to €66,646 million (Dec. 31, 2019: €67,006 million). The decrease is mainly due to currency translation effects outweighing the expansion of business activities. Current assets increased by 3% (10% in constant currency) to €15,772 million (Dec. 31, 2019: €15,264 million), mainly driven by the increase of cash and cash equivalents. Non-current assets decreased by 2% (increased by 3% in constant currency) to €50,874 million (Dec. 31, 2019: €51,742 million).

Total shareholders’ equity decreased by 2% (increased by 6% in constant currency) to €26,023 million (Dec. 31, 2019: €26,580 million). The equity ratio was 39.0% (Dec. 31, 2019: 39.7%).


Group debt decreased by 5% (-2% in constant currency) to €25,913 million (Dec. 31, 2019: € 27,258 million). Group net debt decreased by 6% (-4% in constant currency) to € 24,076 million (Dec. 31, 2019: € 25,604 million), driven by the exceptional cash flow development.


As of December 31, 2020, the net debt/EBITDA ratio improved to 3.44x1,2 (Dec. 31, 2019: 3.61x1,2) driven by the exceptional cash flow development, despite COVID-19 effects weighing on EBITDA.

 

1 At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures
2 Before special items
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

Increased number of employees
As of December 31, 2020, the number of employees was 311,269 (September 30, 2020: 309,114).

 

Business Segments
Fresenius Medical Care (Financial data according to Fresenius Medical Care press release)
Fresenius Medical Care is the world's largest provider of products and services for individuals with renal diseases. As of December 31, 2020, Fresenius Medical Care was treating 346,553 patients in 4,092 dialysis clinics. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care.

FMC IN FY20 Table

  • 2020 financial targets achieved: 5% revenue and 12% net income growth
  • Reported earnings in Q4 negatively impacted by impairment in the Latin America region and accelerated excess mortality due to COVID-19
  • Growth in home dialysis on track

Sales of Fresenius Medical Care decreased by 4% (increased by 4% in constant currency) to €4,400 million (Q4/19: €4,580 million). Thus, currency translation had a negative effect of 8%. Organic growth was 1%. Acquisitions/divestitures contributed net 3% to growth. In FY/20, Fresenius Medical Care increased sales by 2% (5% in constant currency) to €17,859 million (FY/19: €17,477 million). Thus, currency translation had a negative effect of 3%. Organic growth was 3%. Acquisitions/divestitures contributed net 2% to growth.


Reported EBIT decreased by 25% (-18% in constant currency) to €462 million (Q4/19: €616 million). The decrease was mainly due to a macro-economic driven impairment of goodwill and tradenames in the Latin America segment, unfavorable COVID-19 effects and a lower reimbursement for calcimimetics. The reported EBIT margin was 10.5% (Q4/19: 13.5%). EBIT on an adjusted basis decreased by 1% (increased by 5% in constant currency) to €657 million (Q4/19: €663 million). The EBIT margin on an adjusted basis was 14.9% (Q4/19: 14.5%).


In FY/20, reported EBIT increased by 2% (4% in constant currency) to €2,304 million (FY/19: €2,270 million). The reported EBIT margin was 12.9% (FY/19: 13.0%). EBIT on an adjusted basis increased by 6% (8% in constant currency) to €2,499 million (FY/19: €2,356 million). The EBIT margin on an adjusted basis was 14.0% (FY/19: 13.5%).

 

1 Before special items
2 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Reported net income1 decreased by 48% (-43% in constant currency) to €177 million (Q4/19: €343 million) and increased on an adjusted basis by 1% (6% in constant currency) to €372 million (Q4/19: €368 million). In FY/20, reported net income1 decreased by 3% (-1% in constant currency) to €1,164 million (FY/19: €1,200 million) and increased on an adjusted basis by 10% (12% in constant currency) to €1,359 million (FY/19: €1,236 million).


Operating cash flow was €584 million (Q4/19: €771 million) with a margin of 13.3% (Q4/19: 16.8%). In FY/20, operating cash flow was €4,233 million (FY/19: €2,567 million) with a margin of 23.7% (FY/19: 14.7%). The increase was largely driven by the U.S. federal relief funding and advanced payments under the CARES Act and other COVID-19 relief, as well as working capital improvements driven by cash collections.


For FY/21, Fresenius Medical Care expects revenue2 to grow at a low- to mid-single digit percentage range and net income1,3 to decline at a high-teens to mid-twenties percentage range against the higher than expected 2020 base4.


For further information, also on the FME25 program, please see Fresenius Medical Care’s press release at www.freseniusmedicalcare.com.

 

1 Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
2 FY/20 base: €17,859 million
3 FY/20 base: €1,359 million, before special items; FY/21: before special items
4 These targets are based on the 2020 results excluding the impairment of goodwill and trade names in the Latin America Segment of €195 million. They are inclusive of anticipated COVID-19 effects, in constant currency and exclude special items. Special items include costs related to FME25 and other effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance.
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Fresenius Kabi
Fresenius Kabi offers intravenously administered generic drugs, clinical nutrition and infusion therapies for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products. In the biosimilars business, Fresenius Kabi develops products with a focus on oncology and autoimmune diseases.

Kabi IN FY 20 Table

  • In North America fewer elective treatments, competitive pressure and temporary manufacturing issues outweighed extra demand for COVID-19 related products
  • Europe showed strong organic sales growth in Q4 primarily based on extra demand for COVID-19 related products; China with healthy organic growth
  • Strong EBIT growth in Emerging Markets with positive development in China only partially compensates EBIT decrease in North America

 

Sales increased by 3% (8% in constant currency) to €1,815 million (Q4/19: €1,766 million). Organic growth was 7%. Negative currency translation effects of 5% were mainly related to weakness of the US dollar, the Brazilian real and the Argentinian peso. Estimated COVID-19 effects made a slight positive contribution to sales growth. In FY/20, sales increased by 1% (4% in constant currency) to €6,976 million (FY/19: €6,919 million). Organic growth was 4%. Negative currency translation effects of 3% were mainly related to the weakness of the US dollar, the Brazilian real and the Argentinian peso. Estimated COVID-19 effects slightly reduced sales growth.


Sales in North America decreased by 10% (organic growth: -3%) to €549 million (Q4/19: €609 million). The decrease was driven by fewer elective treatments, supply constraints for certain products due to temporary manufacturing issues and competitive pressure, which outweighed extra demand for COVID-19 related products. In FY/20, sales in North America decreased by 2% (organic growth: 0%) to €2,376 million (FY/19: €2,424 million). Sales in Europe increased by 13% (organic growth: 9%) to €680 million (Q4/19: €604 million) mainly due to increased demand for COVID-19 related products. In FY/20, sales in Europe increased by 6% (organic growth: 6%) to €2,458 million (FY/19: €2,313 million). Sales in Asia-Pacific increased by 11% (organic growth: 14%) to €428 million (Q4/19: €385 million). While China saw a solid recovery based on increasing elective procedures, other Asian markets were lagging behind. In FY/20, sales in Asia-Pacific decreased by 1% (organic growth: 1%) to €1,497 million (FY/19: €1,506 million). Sales in Latin America/Africa decreased by 6% (organic growth: 16%) to €158 million (Q4/19: €168 million). In FY/20, sales in Latin America/Africa decreased by 5% (organic growth: 17%) to €645 million (FY/19: €676 million).

 

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

EBIT before special items decreased by 17% (-10% in constant currency) to €236 million (Q4/191: €285 million) with an EBIT margin before special items of 13.0% (Q4/191:16.1%). The decline is driven by headwinds leading to some underutilized production capacities in the US, coupled with selective supply constraints due to temporary manufacturing issues, incremental COVID-19 related expenses, competitive pressure, a negative effect due to the bankruptcy of a customer as well as planned SG&A spending ahead of the launch of the company’s first US biosimilar. Lower corporate costs due to travel restrictions and phasing of projects partially offset the decline. Estimated COVID-19 effects had a moderate negative impact on EBIT growth in Q4/20. In FY/20, EBIT before special items decreased by 9% (-6% in constant currency) to €1,095 million (FY/191: €1,205 million) with an EBIT margin before special items of 15.7% (FY/191: 17.4%). Estimated COVID-19 effects had an insignificant impact on EBIT growth in FY/20.


Net income1,2 decreased by 19% (-11% in constant currency) to €148 million (Q4/191: €183 million). In FY/20, net income1,2 decreased by 8% (-5% in constant currency) to €730 million (FY/191: €797 million).


Operating cash flow increased to €307 million (Q4/19: €291 million) with a margin of 16.9% (Q4/19: 16.5%). In FY/20, operating cash flow increased by 11% to €1,143 million (FY/19: €1,028 million) with a margin of 16.4% (FY/19: 14.9%) due to the favorable working capital development.


For FY/21, Fresenius Kabi expects organic sales3 growth in a low to mid-single digit percentage range. Constant currency EBIT4 is expected to show a stable development up to low single digit percentage growth. Both sales and EBIT outlook include expected COVID-19 effects.

 

1 Before special items
2 Net income attributable to shareholders of Fresenius SE & Co. KGaA
3 FY/20 base: €6,976 million
4 FY/20 base: €1,095 million, before special items, FY/21: before special items
For a detailed overview of special items please see the reconciliation tables on pages 20-22 in the PDF document.

 

Fresenius Helios
Fresenius Helios is Europe's leading private hospital operator. The company comprises Helios Germany and Helios Spain (Quirónsalud). Helios Germany operates 89 hospitals, ~130 outpatient centers and 6 prevention centers. Quirónsalud operates 46 hospitals, 70 outpatient centers and around 300 occupational risk prevention centers. In addition, the company is active in Latin America with 6 hospitals and as a provider of medical diagnostics.

Helios IN FY 20 Table

  • Recovery of elective procedures in Spain in Q4
  • Continued financial support provided by German government throughout Q4
  • Helios Spain with strong organic sales and EBIT growth based on catch-up effects additionally fueled by contributions from acquisitions in Latin America

 

Sales increased by 13% (13% in constant currency) to €2,637 million (Q4/19: €2,344 million). Organic growth was 9%. Acquisitions contributed 4% to sales growth. COVID-19 effects had an insignificant effect on organic growth. In FY/20, sales increased by 6% (7% in constant currency) to €9,818 million (FY/19: €9,234 million). Organic growth was 4%. Acquisitions contributed 3% to sales growth. COVID-19 effects had a slight negative impact on organic growth.


Sales of Helios Germany increased by 11% (organic growth: 8%) to €1,637 million (Q4/19: €1,475 million). In FY/20, sales of Helios Germany increased by 7% (organic growth: 6%) to €6,340 million (FY/19: €5,940 million). COVID-19 effects were mitigated by government financial support and hence had only a slight negative impact on organic growth in both Q4/20 and FY/20.


Sales of Helios Spain increased by 15% (17% in constant currency) to €999 million (Q4/19: €867 million). Organic growth of 11% was driven by a strong recovery of elective procedures and a consistently high level of outpatient treatments. Thus, COVID-19 effects had a moderate positive impact on organic growth in Q4. The hospital acquisitions in Colombia contributed 6% to sales growth. In FY/20, sales of Helios Spain increased by 6% (7% in constant currency) to €3,475 million (FY/19: €3,292 million). Organic growth was 2%. Acquisitions contributed 5% to sales growth. COVID-19 effects had a significant negative impact on organic sales growth.

 

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

 

EBIT of Fresenius Helios increased by 12% (13% in constant currency) to €328 million (Q4/19: €294 million) with an EBIT margin of 12.4% (Q4/19: 12.5%). COVID-19 effects, in particular due to the strong recovery of elective procedures in Spain, had a significant positive effect on EBIT growth in Q4. In FY/20, EBIT of Fresenius Helios remained on prior year’s level (0% in constant currency) at €1,025 million (FY/19: €1,025 million) with an EBIT margin of 10.4% (FY/19: 11.1%). COVID-19 effects had a moderate negative impact on EBIT growth.


EBIT of Helios Germany increased by 10% to €157 million (Q4/19: €143 million) with an EBIT margin of 9.6% (Q4/19: 9.7%). Financial support provided by the German government under revised regulations focusing on regions with high COVID incidences broadly offset additional headwinds as Helios Germany continued to play a crucial role in treating COVID-19 patients. In FY/20, EBIT of Helios Germany increased by 4% to €602 million (FY/19: €577 million) with an EBIT margin of 9.5% (FY/19: 9.7%). Due to the comprehensive financial support provided by the German government, COVID-19 effects had an overall insignificant impact on the EBIT development.


EBIT of Helios Spain increased by 17% (19% in constant currency) to €159 million (Q4/19: €136 million) with an EBIT margin of 15.9% (Q4/19: 15.7%). The growth is driven by a recovery of elective procedures following the government-ordered postponement of planned surgical procedures in Q2, where medically justifiable. Thus, COVID-19 effects had a significant positive effect on EBIT growth in Q4. In FY/20, EBIT of Helios Spain decreased by 5% (-5% in constant currency) to €420 million (FY/19: €443 million) with an EBIT margin of 12.1% (FY/19: 13.5%). COVID-19 effects had a very significant negative impact on EBIT growth with missing or delayed elective procedures and higher expenses amid the comprehensive efforts to combat the pandemic.


Net income1 increased by 14% to €225 million (Q4/19: €197 million). In FY/20, net income1 remained on prior year’s level at €666 million (FY/19: €664 million).


Operating cash flow increased to €434 million (Q4/19: €226 million) with a margin of 16.5% (Q4/19: 9.6%), driven by phasing of payments under the German law to ease the financial burden on hospitals. In FY/20, operating cash flow increased to €1,149 million (FY/19: €733 million) with a margin of 11.7% (FY/19: 7.9%).

 

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

 

For FY/21, Fresenius Helios expects organic sales1 growth in a low to mid-single digit percentage range and constant currency EBIT2 growth in a mid to high single digit percentage range. Both sales and EBIT outlook include expected COVID-19 effects.

 

1 FY/20 base: €9,818 million
2 FY/20 base: €1,025 million; FY/21 before special items

 

Fresenius Vamed
Fresenius Vamed manages projects and provides services for hospitals and other health care facilities worldwide and is a leading post-acute care provider in Central Europe. The portfolio ranges along the entire value chain: from project development, planning, and turnkey construction, via maintenance and technical management to total operational management.

Vamed IN FY 20 Table

  • Significant COVID-19 impact in the project business related to delays, cancellations and global supply chain restraints continued
  • Good order intake in Q4 indicates first signs of recovery in project business
  • Rehabilitation business continued to be impacted by less demand for rehabilitation treatments and postponements of elective surgeries; technical service business remained robust

 

Sales decreased by 22% (-22% in constant currency) to €577 million (Q4/19: €737 million). Organic growth was -22%. Acquisitions did not contribute to growth. Estimated COVID-19 effects had a very significant negative impact on growth. In FY/20, sales decreased by 6% (-6% in constant currency) to €2,068 million (FY/19: €2,206 million). Organic growth was -8%. Acquisitions contributed 2% to growth. Estimated COVID-19 effects had a very significant negative impact on growth.


Sales in the service business decreased by 1% to €372 million (Q4/19: €374 million).
Sales in the project business decreased by 44% to €205 million (Q4/19: €363 million), driven by postponements and cancellations of projects. In FY/20, sales in the service business grew by 3% to €1,435 million (FY/19: €1,399 million). Sales in the project business decreased by 22% to €633 million (FY/19: €807 million).

 

1 Net income attributable to shareholders of VAMED AG

 

EBIT decreased by 42% (-42% in constant currency) to €39 million (Q4/19: €67 million) with an EBIT margin of 6.8% (Q4/19: 9.1%). Estimated COVID-19 effects had a very significant negative impact on EBIT. Capacities in the post-acute care clinics were left partially empty given a generally lower intake of elective surgery patients from acute-care hospitals. Authority-instigated restrictions or even closures of individual facilities also had a negative effect. In the project business, project delays and global supply chain restraints triggered incremental expenses. In FY/20, EBIT decreased by 78% (-79% in constant currency) to €29 million (FY/19: €134 million) with an EBIT margin of 1.4% (FY/19: 6.1%). Estimated COVID-19 effects had a very significant negative impact on EBIT.


Net income1 decreased to €25 million (Q4/19: €44 million). In FY/20, net income1 decreased to €2 million (FY/19: €83 million).


Order intake was €648 million in Q4/20 (Q4/19: €576 million) and €1,010 million in FY/20 (FY/19: €1,314 million). As of December 31, 2020, order backlog was at €3,055 million (December 31, 2019: €2,865 million). Order intake and order backlog were marked by COVID-19 related cancellations and project delays.


Operating cash flow increased to €74 million (Q4/19: €0 million) with a margin of 12.8% (Q4/19: 0%), driven by a favorable working capital development mainly related to pre-payments. In FY/20, operating cash flow increased to €78 million (FY/19: -€17 million) with a margin of 3.8% (FY/19: -0.8%).


For FY/21, Fresenius Vamed expects organic sales2 growth in a mid to high single digit percentage range and EBIT3 to grow to a high double-digit euro million amount. Both sales and EBIT outlook include expected negative COVID-19 effects.

 

1 Net income attributable to shareholders of VAMED AG
2 FY/20 base: €2,068 million
3 FY/20 base: €29 million; FY/21 before special items

 

Conference Call
As part of the publication of the results for FY 2020, a conference call will be held on February 23, 2021 at 1:30 p.m. CET (7:30 a.m. EST). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/investors. Following the call, a replay will be available on our website.

For additional information on the performance indicators used please refer to our website https://www.fresenius.com/alternative-performance-measures.

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.

March 11

March 11, 2021
Bad Homburg, Germany

Barclays Global Healthcare Conference

February 25

February 25, 2021
Bad Homburg, Germany

Berenberg Bank – Virtual Global Roadshow

February 26

February 26, 2021
Bad Homburg, Germany

Virtual Global Roadshow

February 24

February 24, 2021
Bad Homburg, Germany

Kepler Cheuvreux – Virtual Global Roadshow

Fresenius Kabi Oncology Ltd. (FKOL), India, has reached an agreement with the U.S. Department of Justice (DOJ) that would conclude an investigation of events that took place in 2013.

In 2013, FKOL notified the FDA immediately upon discovering that certain employees at the company’s plant in Kalyani, India, had failed to provide relevant records during an FDA inspection. These individuals acted in violation of Fresenius Kabi’s compliance requirements, code of conduct and values. As a consequence, their employment was terminated immediately. Fresenius informed the public about these events in July 2013.

Patient safety was and has continued to be safeguarded at all times. Product supplied from this plant was within specifications. All necessary remediation actions were successfully implemented many years ago, and the plant has been fully operational ever since.

Under the agreement, which still must be reviewed and accepted by the United States District Court for the District of Nevada, FKOL will make a payment of USD 50 million. Given past accruals for this matter, the resolution will be net income neutral. The agreement includes a compliance addendum under which FKOL will build on its existing quality compliance management system to monitor compliance and provide the DOJ with regular reports on its effectiveness.

Mats Henriksson, CEO of Fresenius Kabi, said: “While we are pleased to have reached this resolution, we regret that such events happened years ago in one of our plants. In line with our commitment to highest ethical and quality standards, we immediately and consequently took all necessary measures to remedy the situation in full cooperation with the authorities. As a reliable partner of health care systems around the world, we continuously strive for the highest standards in pharmaceutical manufacturing.”

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 Kabi is further expanding its Austrian facilities. The company will invest more than €60 million through 2023 to expand capacity and upgrade infrastructure at its production plant in Graz and packaging center in nearby Werndorf. The measures will be focused on the freeze-drying area and the lines for filling and packing glass bottles and ready-to-administer prefilled syringes.

“Prefilled syringes are a fast-growing market for us,” said Plant Manager Dr. Ruth Staubmann. “Many healthcare institutions and organizations recognize the clear advantages in terms of their rapid application and, above all, safety of use.” The expansion of the Graz plant will approximately double production capacity in this product category.

Fresenius Kabi produces liquid pharmaceuticals and clinical nutrition products for the Austrian and international markets in Graz. The site has special expertise in aseptic production and the manufacturing of complex products such as anesthetics, analgesics, anti-infectives and antibiotics. It also makes clinical nutrition products. In total, Fresenius Kabi currently has more than 900 employees in Graz. The number of additional jobs that will be created through the expansion cannot yet be determined.

In addition to the Graz plant and the packaging and logistics center in Werndorf, Fresenius Kabi’s Austrian operations include a research and development center in Grambach and a plant and distribution facility in Linz that specializes in the production of active ingredients and lactulose. The company employs a total of about 1,500 people in Austria.

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.

March 01

March 01, 2021
Bad Homburg, Germany

Morgan Stanley – European MedTech & Services Conference

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