Contact

T +49 (0) 6172 608-4030
leif.heussen@fresenius.com

Documents

Text as PDF document (PDF, 315 KB)

• Continued solid organic growth in Care Enablement and Care Delivery including sequentially stable same market treatment growth in the U.S. 
• Successful execution on turnaround plan driving productivity improvements in Care Delivery and pricing in Care Enablement    
• FME25 transformation savings fully on track
• Continued execution on portfolio optimization strategy
• FY 2023 earnings outlook raised 

Helen Giza, Chief Executive Officer of Fresenius Medical Care, said: “Our unwavering focus on executing against our strategic plan and the successful implementation of turnaround measures to date, continue to translate into improved operating performance. Notably in the third quarter, we continued to unlock sustainable savings with our FME25 program, further improved our labor productivity and continued to execute on our portfolio optimization plan. Given our improving performance for the first nine months of the year and solid expectations for the remainder of the year, we confidently upgrade our full year earnings outlook.” 

Successful execution against the strategic plan

Fresenius Medical Care has continuously advanced its structural change. After implementing the new operating model along with the corresponding new financial reporting, the simplification of the governance structure through a legal form conversion remains on track to be completed by 1 December 2023. 

Fresenius Medical Care continues to successfully execute on its operational efficiency and turnaround plans. In the third quarter, the FME25 transformation program delivered EUR 97 million of savings, resulting in EUR 232 million for the first nine months of the year. The Company is fully on track to achieve sustainable savings of EUR 250 to 300 million by year end 2023 and EUR 650 million by year end 2025.

Moreover, Fresenius Medical Care is executing its portfolio optimization plan to exit non-core and dilutive assets. In the third quarter, the Company entered into an agreement to sell National Cardiovascular Partners (NCP) with 21 facilities providing outpatient cardiac catheterization and vascular laboratory services, which are included in the U.S. Care Delivery business, in connection with its Legacy Portfolio Optimization program.

¹ For FY 2022, special items included costs related to the FME25 program, the impact of the war in Ukraine, the impact of hyperinflation in Turkiye, the Humacyte investment remeasurement and the net gain related to InterWell Health. Additionally, the FY 2022 basis for the 2023 outlook was adjusted for U.S. Provider Relief Funding. For FY 2023, special items include costs related to the FME25 program, the Humacyte investment remeasurement, the costs associated with the legal form conversion and effects from legacy portfolio optimization. For further details please see the reconciliation attached to the Press Release.

² Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA

In line with the Company’s disciplined financial policy, Fresenius Medical Care has already refinanced a bond of EUR 650 million, maturing in November 2023. The Company is using a mix of long-term bank financing at very attractive financing conditions as well as cash and short-term debt. Upcoming extraordinary cash inflows will enable the Company to further delever.

Revenue development supported by solid organic growth 

Revenue decreased by 3% to EUR 4,936 million in the third quarter (+7% at constant currency, +7% organic).

Care Delivery revenue decreased by 4% to EUR 3,974 million (+6% at constant currency, +7% organic).

In Care Delivery U.S., revenue declined by 3% (+4% at constant currency, +5% organic). A negative exchange rate effect and a decrease in dialysis days was partially offset by organic growth, which was supported by a favorable impact from the value-based care business, reimbursement rate increases and a favorable payor mix. The annualization effect of COVID-19-related excess mortality in the late-stage CKD (Chronic Kidney Disease) and ESRD (End-Stage Renal Disease) population continues to weigh on same market treatment growth (-0.4%). Adjusted for the exit from less profitable acute care contracts same market treatment growth was at +0.2%.

In Care Delivery International, revenue declined by 7% (+14% at constant currency, +16% organic). A negative exchange rate effect and the impact of closed or sold clinics was partially offset by organic growth, which was driven by a significant effect of hyperinflation in various markets. Despite the annualization effect of COVID-19-related excess mortality, same market treatment growth was positive at 1.6%.

Care Enablement revenue declined by 3% to EUR 1,330 million (+5% at constant currency, +5% organic). The negative exchange rate effects have been partly offset by higher sales of in-center disposables, machines for chronic treatment and home hemodialysis products as well as higher average sales prices. 

Within Inter-segment eliminations, revenue for products transferred between the operating segments at fair market value declined by 10% to EUR 368 million (-1% at constant currency).  

In the first nine months, revenue was stable at EUR 14,466 million (+5% at constant currency, +5% organic). Care Delivery revenue was stable at EUR 11,602 million (+4% at constant currency, +5% organic), with stable revenue for Care Delivery U.S. (+2% at constant currency, +3% organic), and a revenue decline of 1% for Care Delivery International (+13% at constant currency, +14% organic). Care Enablement revenue was stable at EUR 3,965 million (+5% at constant currency, +5% organic). Inter-segment eliminations declined by 5% and amounted to EUR 1,101 million (stable at constant currency).³

³ The Company transfers products between segments at fair market value. The associated internal revenues and expenses and any remaining internally generated profit or loss for the product transfers are recorded within the operating segments initially, are eliminated upon consolidation and are included within “Inter-segment eliminations”.

Earnings development driven by productivity improvements and FME25 savings

Operating income decreased by 31% to EUR 324 million (-28% at constant currency), resulting in a margin of 6.6% (Q3 2022: 9.3%). Operating income excluding special items and U.S. Provider Relief Funding (PRF)1 increased by 14% to EUR 431 million (+20% at constant currency), resulting in a margin of 8.7% (Q3 2022: 7.4%).

Operating income in Care Delivery decreased by 34% to EUR 332 million (-29% at constant currency), resulting in a margin of 8.4% (Q3 2022: 12.1%). Operating income excluding special items and PRF1 increased by 11% to EUR 410 million (+17% at constant currency), resulting in a margin of 10.3% (Q3 2022: 9.0%). This was mainly driven by business growth, savings from the FME25 program and lower personnel expenses resulting from improved productivity. The operating income development was negatively impacted by lower income attributable to a non-recurring consent payment for certain pharmaceuticals, inflationary cost increases as well as by foreign currency translation. 

Operating income in Care Enablement amounted to EUR -1 million (Q3 2022: EUR -26 million), resulting in a margin of -0.1% (Q3 2022: -1.9%). Operating income excluding special items increased by 197% to EUR 22 million (+217% at constant currency), resulting in a margin of 1.7% (Q3 2022: 0.5%). The improvement compared to the previous year’s quarter was mainly driven by increased volumes, improved pricing and savings from the FME25 program. These effects were partially offset by inflationary cost increases and negative foreign currency transaction effects.

Operating income for Corporate amounted to EUR -8 million (Q3 2022: EUR -7 million). Excluding special items, operating income amounted to EUR -2 million (Q3 2022: EUR -6 million).

In the first nine months, operating income decreased by 19% to EUR 942 million (-18% at constant currency), resulting in a margin of 6.5% (9M 2022: 8.1%). Excluding special items and PRF1, operating income increased by 13% to EUR 1,186 million (+14% at constant currency), resulting in a margin of 8.2% (9M 2022: 7.3%). In Care Delivery, operating income declined by 19% to EUR 1,001 million (-18% at constant currency), resulting in a margin of 8.6% (9M 2022: 10.6%). In Care Enablement, operating income decreased to EUR -24 million (9M 2022: EUR 33 million), resulting in a margin of -0.6% (9M 2022: 0.8%). Operating income for Corporate amounted to EUR -23 million (9M 2022: EUR -101 million). 

Net income² decreased by 63% to EUR 84 million (-61% at constant currency). Excluding special items and PRF1, net income2 remained stable at EUR 168 million (+5% at constant currency). 

In the first nine months, net income² declined by 42% to EUR 311 million (-41% at constant currency). Excluding special items and PRF1, net income² increased by 3% to EUR 497 million (+5% at constant currency).

Basic earnings per share (EPS) decreased by 63% to EUR 0.29 (-61% at constant currency). EPS excluding special items and PRF1 remained stable at EUR 0.57 (+5% at constant currency).

In the first nine months, EPS declined by 42% to EUR 1.06 (-41% at constant currency). Excluding special items and PRF¹, EPS increased by 3% to EUR 1.69 (+5% at constant currency).

 
Strong cash flow development

In the third quarter, Fresenius Medical Care generated EUR 760 million of operating cash flow (Q3 2022: EUR 658 million), resulting in a margin of 15.4% (Q3 2022: 12.9%). The increase in net cash provided by operating activities is the result of the change in certain working capital items, in particular due to the recoupment of advanced payments during 2022, which had been received under the U. S. Medicare Accelerated and Advance Payment Program in 2020.

In the first nine months, operating cashflow amounted to EUR 1,910 million (9M 2022: EUR 1,568 million), resulting in a margin of 13.2% (9M 2022: 10.9%). 

Free cash flow⁴  amounted to EUR 626 million in the third quarter (Q3 2022: 
EUR 501 million), resulting in a margin of 12.7% (Q3 2022: 9.8%). In the first nine months, Fresenius Medical Care generated free cash flow of EUR 1,480 million (9M 2022: EUR 1,082 million), resulting in a margin of 10.2% (9M 2022: 7.5%).

Outlook

The Company continues to expect for 2023 revenue to grow at a low to mid-single digit percentage rate (2022 basis: EUR 19,398 million). 

Based on the earnings development for the first nine months of the year and solid business expectations for the remainder of the year, Fresenius Medical Care raises its earnings outlook for 2023. The Company now expects operating income to grow at a low-single digit percentage rate (2022 basis: EUR 1,540 million; previous target: remain flat or decline by up to a low-single digit percentage rate)⁵.

The Company’s target to achieve an operating income margin of 10 to 14% by 2025 remains unchanged.

⁴ Net cash provided by / used in operating activities, after capital expenditures, before acquisitions, investments, and dividends

⁵ Revenue and operating income, as referred to in the outlook, are both on a constant currency basis and excluding special items. Special items will be provided as separate KPI (“Revenue excluding special items”, “Operating income excluding special items”) to capture effects that are unusual in nature and have not been foreseeable or not foreseeable in size or impact at the time of giving guidance. These items are excluded to ensure comparability of the figures presented with the Company’s financial targets which have been defined excluding special items.
For FY 2022, special items included costs related to the FME25 program, the impact of the war in Ukraine, the impact of hyperinflation in Turkiye, the Humacyte investment remeasurement, and the net gain related to InterWell Health. Additionally, the basis (FY 2022) for the 2023 outlook was adjusted for Provider Relief Funding. For FY 2023, special items include costs related to the FME25 program, the Humacyte investment remeasurement, the costs associated with the legal form conversion and effects from legacy portfolio optimization. For further details please see the reconciliation attached to the Press Release.

Patients, clinics and employees

As of September 30, 2023, Fresenius Medical Care treated 341,793 patients in 4,014 dialysis clinics worldwide and had 123,106 employees (headcount) globally, compared to 130,295 employees as of September 30, 2022.

Conference call

Fresenius Medical Care will host a conference call to discuss the results of the third quarter on November 2, 2023 at 3:30 p.m. CET / 10:30 a.m. EDT. Details will be available on the Fresenius Medical Care website in the “Investors” section. A replay will be available shortly after the call.

Please refer to our statement of earnings included at the end of this news and to the attachments as separate PDF files for a complete overview of the results of the third quarter and first nine months of 2023. Our 6-K disclosure provides more details.

Contact

T +49 (0)175 962 77 51
friederike.segeberg@fresenius.com

Further content

• Investor News Q3 2023 (PDF, 655 KB)

All | None

Download

Documents

Text as PDF document (PDF, 200 KB)

• Excellent Group revenue growth of 6% in constant currency to €5.5 billion; driven by Operating Companies and Fresenius Vamed
• Group EBIT increased 10% in constant currency, reflecting strong performance of Operating Companies; Fresenius Vamed with operational improvement 
• Fresenius Kabi with strong organic revenue growth of 7% at top-end of structural growth band; EBIT margin remains within structural band at 14.3% 
• Fresenius Helios with strong organic revenue growth of 5% at top-end of structural growth band despite usual summer effect in Spain
• Fresenius Vamed transformation progressing
• Deconsolidation of Fresenius Medical Care effective by December 2023
• Divestments advancing: exit of hospital operations in Peru 
• FY/23 structural productivity savings target of ~€200 million excluding Fresenius Medical Care already achieved in first nine months
• Group revenue outlook confirmed, Group EBIT outlook improved
• Application of IFRS 5: Fresenius Group financials for the first time presented excluding Fresenius Medical Care 

Michael Sen, CEO of Fresenius: “Fresenius had a great 3rd Quarter 2023. We made progress on every part of our #FutureFresenius program, including simplification of our corporate structure, and achieved cost savings well ahead of our targets for the full year 2023. At the same time, we are moving ahead with the divestment of non-core businesses. The focus on our two Operating Companies, Kabi and Helios, is paying off, with strong revenue and earnings development. Both businesses again announced important innovations, new products and strong partnerships to improve patient outcomes. And this gets a lot of recognition even beyond the industry. Given our strong performance throughout the first three quarters of the year, we are improving our operating earnings outlook for 2023 and expect constant currency Group EBIT to remain broadly flat year on year. This momentum will allow us to continue to build trust, deliver consistent performance, and stay focused on our purpose: Advancing Patient Care.”

Fresenius Group – Business Development 

Group revenue increased by 2% (6% in constant currency) to €5,518 million (Q3/22: €5,386 million). Organic growth was 6%. Acquisitions/divestitures contributed net 0% to growth. In total, currency translation had a negative effect of 4% on revenue growth. The Operating Companies increased revenue by 1% (5% in constant currency). 

Group EBITDA before special items increased by 9% (11% in constant currency) to €821 million (Q3/22¹: €755 million). Reported Group EBITDA was €661 million (Q3/22: €691 million).

Group EBIT before special items increased by 8% (10% in constant currency) to €519 million (Q3/22¹: €480 million), mainly driven by the good earnings development at the Operating Companies. The EBIT margin before special items was 9.4% (Q3/22¹: 8.9%). Reported Group EBIT was €346 million (Q3/22: €416 million). The Operating Companies achieved an EBIT increase of 8% (10% in constant currency) and an EBIT margin of 10.3%. 

Group net interest before special items increased to -€109 million (Q3/22¹: -€67 million) mainly due to financing activities in a higher interest rate environment. Reported Group net interest was -€100 million (Q3/22: -€67 million). 

¹ Before special items

The Group tax rate before special items was 24.1% (Q3/22¹: 22.5%). Reported Group tax rate was 37.0%. The higher tax rate in Q3/23 is mainly due to the negative net income at Fresenius Vamed for which deferred tax assets could not be recognized (Q3/22: 23.5%).

Group net income² before special items decreased by 7% (-5% in constant currency) to €344 million (Q3/221: €371 million). The decrease was driven by rising interest costs and a higher tax rate as well as lower net income from operations to be deconsolidated (Fresenius Medical Care). Reported Group net income² decreased to -€406 million (Q3/22: €321 million). The negative net income is due to the Fresenius Medical Care valuation effect according to IFRS 5 of €594 million. This effect has no cash impact.

Earnings per share² before special items decreased by 8% (-6% in constant currency) to €0.61 (Q3/221: €0.66). Reported earnings per share² were -€0.72 (Q3/22: €0.57). The negative net income is due to the Fresenius Medical Care valuation effect according to IFRS 5 of €594 million. This effect is without any cash impact.

Group operating cash flow increased to €648 million (Q3/22: €598 million), mainly driven by the good cash flow development at Fresenius Kabi. Free cash flow before acquisitions, dividends and lease liabilities remained broadly stable at €376 million (Q3/22: €375 million). 

As of September 30, 2023, the net debt/EBITDA ratio was 4.03x^1,3  (Dec. 31, 2022: 3.80x^1,3). This is a reduction of 15 basis points compared to Q2/23.

The groupwide cost savings program progresses significantly ahead of plan. Under the program, Fresenius realized ~€200 million of structural cost savings at EBIT level in Q1-3/23. With that, all savings originally expected for 2023 are already realized. In the same period, one-time costs of around €90 million incurred to achieve these savings. This is well below what the Company initially accounted for and testament that our one-time costs are tightly managed.

¹ Before special items
² Net income attributable to shareholders of Fresenius SE & Co. KGaA
³ At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures, including lease liabilities, including Fresenius Medical Care dividend
On Group level including Fresenius Medical Care, the savings in Q1-3/23 amount to ~€430 million. In the same period, one-time costs of ~€190 million incurred to achieve these savings. 

Operating Company Fresenius Kabi 

In Q3, revenue decreased by 2% to €2,021 million (Q3/22: €2,071 million), driven by negative currency exchange effects (increased 7 % in constant currency). Organic growth was 7%. The largest contribution to revenues came from the Pharma (IV Drugs & Fluids) business. There, revenue decreased by 5% (0% in constant currency, organic growth: 1%) and amounted to €941 million (Q3/22: €995 million). Organic growth was mainly driven by a robust development across the regions. The Biopharma business recorded the strongest increase in revenues of 74% (99% in constant currency, organic growth: 71%) to €111 million (Q3/22: €64 million), which is mainly driven by the successful product launches in Europe and the U.S. as well as by licensing agreements.

EBIT¹ of Fresenius Kabi increased by 3% (6% in constant currency) to €289 million (Q3/22: €280 million) due to the good operating performance and the well-progressing cost saving initiatives. EBIT margin¹ was 14.3% (Q3/22: 13.5%) and thus within the structural EBIT margin band. Net income^1,2 increased by 3% (7% in constant currency) to €189 million (Q3/22: €184 million). Operating cash flow increased to €380 million (Q3/22: €301 million) with a margin of 18.8% (Q3/22: 14.5%), mainly driven by strong business performance and improved working capital management.  

For FY/23, Fresenius Kabi expects organic revenue³ growth in a mid-single-digit percentage range. The EBIT margin⁴ is expected to be around 14% (structural margin band: 14% to 17%).

¹ Before special items
² Net income attributable to shareholders of Fresenius SE & Co. KGaA.
³ FY/22 base: €7,850 million
⁴ FY/22 base: EBIT margin: 13.8%, before special items; FY/23 before special items
Just recently, Fresenius Kabi announced the European market launch of Tyenne®. This is the first tocilizumab biosimilar to be launched in the European Union for the treatment of a variety of inflammatory and autoimmune diseases such as rheumatoid arthritis. The growing portfolio of biosimilars for inflammatory and immune diseases and oncology is further evidence of Fresenius Kabi's successful Vision 2026 growth strategy. In this context, Fresenius Kabi and Lupagen Inc. have signed a development and supply agreement for technologies designed to bring the delivery of cell and gene therapies to the bedside. Cell and gene therapies have shown promise in the treatment of a variety of diseases, including cancer, hematological, autoimmune and rare diseases.

Operating Company Fresenius Helios

In Q3, revenue increased by 4% (5% in constant currency) to 2,953 million (Q3/22: €2,829 million). Organic growth was 5%. Revenue of Helios Germany increased by 4% (organic growth: 4%) to €1,800 million (Q3/22: €1,731 million), mainly driven by increasing admissions and positive price mix effects. Revenue of Helios Spain increased by 5% (5% in constant currency) to €1,088 million (Q3/22: €1,037 million), driven by ongoing high activity levels despite the usual summer effect in Spain. The clinics in Latin America also showed a good performance. Organic growth was 5%. Revenue of Helios Fertility increased by 3% (11% in constant currency) to €64 million (Q3/22: €62 million) driven by positive mix effects. Organic growth was 10%.

EBIT¹ of Fresenius Helios increased by 8% (8% in constant currency) to €239 million (Q3/22: €222 million) with an EBIT margin¹ of 8.1% (Q3/22: 7.8%). 
The strongest increase was recorded by Helios Germany, where EBIT¹ increased by 11% to €157 million (Q3/22: €141 million) with an EBIT margin¹ of 8.7% (Q3/22: 8.1%). The EBIT development was supported by the well progressing cost savings program and the Government compensation for higher energy costs. 

Net income^1,2 decreased by 4% (-4% in constant currency) to €132 million (Q3/22: €138 million). Operating cash flow decreased to €208 million (Q3/22: €353 million), mainly due to phasing effects of receivables in Spain and the very good cashflow in the prior year.

For FY/23, Fresenius Helios expects organic revenue³ growth in a mid-single-digit percentage range. The EBIT margin⁴ is expected to be within the structural margin band of 9% to 11%.

¹ Before special items
² Net income attributable to shareholders of Fresenius SE & Co. KGaA
³ FY/22 base: €11,716 million
⁴ FY/22 base: EBIT margin: 10.1%, before special items, FY/23 before special items
Digitalization is an important topic in the healthcare sector, and Fresenius Helios is pushing ahead with it. For example, the Helios ENDO clinic in Hamburg is piloting the use of Artificial Intelligence (AI) in building automation with a so-called “digital twin”. As a pioneer in the use of AI in hospital building technology, Fresenius is thus taking an important step towards its goal of becoming climate neutral by 2040. The Spanish hospital chain Quirónsalud has also continued to develop its activities: a state-of-the-art medical center with 18 specialties was opened in Madrid during the reporting period. Such investments pay off: five Quirónsalud hospitals have been recognized by a renowned U.S. news magazine in its "World's Best Specialized Hospitals 2024" ranking.

Deconsolidation of Fresenius Medical Care 

The deconsolidation process of Fresenius Medical Care is on track. The competent Higher Regional Court in Bamberg has fully approved the application for release that Fresenius Medical Care had filed with regard to the legal actions brought against the change of the legal form into a stock corporation. Accordingly, the change of the legal form can be registered with the commercial register. Fresenius expects the deconsolidation to become effective by December 2023. From then on, Fresenius Medical Care AG & Co. KGaA will operate as Fresenius Medical Care AG.

As a result of the approval of the change of legal form by the Extraordinary General Meeting on July 14, 2023, Fresenius Medical Care is for the first time in Q3/23 presented as a single item in the financial statements of the Fresenius Group. 

Fresenius Medical Care is now classified in accordance with IFRS 5 as "Operations to be deconsolidated” and presented in a single line item in Fresenius’s balance sheet, the P&L and the cash flow statement. 

IFRS 5 requires the valuation of Fresenius Medical Care at fair value. As of September 30, 2023, the market capitalization of about €12 billion was below the consolidated shareholders’ equity of Fresenius Medical Care of about €14 billion. This results in a valuation effect of €2 billion, of which ~€0.6 billion are attributable to the shareholders of Fresenius SE & Co. KGaA. This effect is reported as a special item without any cash impact.

Transformation Fresenius Vamed

In Q3/23, further progress was made in the transformation of Fresenius Vamed. The company has started a comprehensive strategic assessment of its business activities and initiated a far-reaching restructuring program to increase the company’s profitability. With a positive EBIT of €10 million in Q3/23 (Q2/23: -€20 million), Fresenius Vamed is ahead of its originally expected target for Q3/23. The encouraging development was especially driven by the High-End Services (HES) and Health Facility Operations (HFO) businesses. For Q4/23, a further solid development is expected.

In Q3/23, negative special items mainly related to closing down activities, asset re-evaluations and restructuring costs resulted in write-downs and provisions of €109 million. The negative special items were predominantly booked as non-cash items. In Q1-3/23, negative special items of €441 million were incurred. 

By 2025, Fresenius Vamed is expected to reach the structural EBIT margin band of 4% to 6% set out in the #FutureFresenius Financial Framework.

FY/23 Group earnings outlook improved 

Based on the consistent performance of the Operating Companies through the year, Fresenius improves the 2023 earnings outlook and now expects constant currency Group EBIT¹ to remain broadly flat compared to FY/2022 (previous: EBIT¹ expected to remain broadly flat to decline up to a mid-single-digit percentage rate). Group organic revenue² continues to be expected to grow in a mid-single-digit percentage range. 

Fresenius expects the net debt/EBITDA³ ratio excluding Fresenius Medical Care to be below 4.0x by the end of 2023, therefore further improving from 4.03x⁴ as of September 30, 2023 (December 31, 2022: 3.80x⁴). This assumption does not include potential divestment activities. The self-imposed target corridor for the leverage ratio remains unchanged at 3.0x to 3.5x.

¹ FY/22 base: €2,190 million, before special items; FY/23: before special items
² FY/22 base: €21,532 million
³ At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; excluding further potential acquisitions/divestitures; before special items; including lease liabilities, including Fresenius Medical Care dividend
⁴ At LTM average exchange rates for both net debt and EBITDA; pro forma closed acquisitions/divestitures; before special items; including lease liabilities, including Fresenius Medical Care dividend

Fresenius Kabi announced today the launch of its tocilizumab biosimilar Tyenne^® referencing RoActemra^®** (tocilizumab) in the European Union. 

Tyenne^® becomes the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases.

Tyenne^® is Fresenius Kabi’s third approved biosimilar launched in Europe, offering patients and heath care providers a flexible range of user-friendly subcutaneous (prefilled syringe and autoinjector) and intravenous (vials) administration. 

* Tyenne^® (tocilizumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries.
** RoActemra^® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

Fresenius Kabi announced today the launch of its tocilizumab biosimilar Tyenne^® referencing RoActemra^®** (tocilizumab) in the European Union. 

Tyenne^® becomes the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases.

Tyenne^® is Fresenius Kabi’s third approved biosimilar launched in Europe, offering patients and heath care providers a flexible range of user-friendly subcutaneous (prefilled syringe and autoinjector) and intravenous (vials) administration. 

* Tyenne^® (tocilizumab) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. 
** RoActemra^® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

Contact

T +49 (0) 6172 608-4030
leif.heussen@fresenius.com

Documents

Text as PDF document (PDF, 86 KB)

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, has appointed Craig Cordola (52) as new Management Board member for the globally operating Care Delivery segment. Cordola will start on January 1, 2024, as Chief Executive Officer of Care Delivery. He will be based in Waltham, Massachusetts. 

Craig Cordola will succeed William (Bill) Valle (63) as part of a planned transition after Mr. Valle informed the Management Board of his intention to retire from the company at the end of 2023. Bill joined Fresenius Medical Care in 2009. He has been leading the globally operating Care Delivery segment since 2022. Previously, he served as CEO for North America since 2017. He has been a member of the Management Board since 2017. Prior to that, he was Executive Vice President responsible for the dialysis service business and vascular access business of Fresenius Medical Care North America from 2014 to 2017. Over the last decade he was responsible for the transformation of the U.S. business into a multi-dimensional integrated kidney care provider.

Craig Cordola is currently Executive Vice President of Ascension Capital, where he is responsible for strategic investments. Previously, he was Executive Vice President and Chief Operating Officer for Ascension. Prior to joining Ascension in 2017, Mr. Cordola held several senior executive and leadership positions at Memorial Hermann Health System in Houston, Texas. He is a Fellow of the American College of Healthcare Executives and holds a degree in Psychology from The University of Texas at Austin. He also earned dual degrees with a Master of Healthcare Administration (MHA) and a Master of Business Administration (MBA) from the University of Houston-Clear Lake.

Michael Sen, Chairman of the Supervisory Board of Fresenius Medical Care Management AG, said: “We are delighted to have Craig Cordola join the Management Board of Fresenius Medical Care as the leader of the global Care Delivery organization. Craig has a wealth of knowledge and experience managing large healthcare systems and organizations. With this expertise, he will be a crucial player in the Management Board in implementing Fresenius Medical Care's turnaround and focusing on patient care.” Michael Sen added: “On behalf of the entire Supervisory Board, I would like to express my sincere appreciation to Bill for his excellent work over the past years, his passion for the well-being of patients and his contribution to the development of Fresenius Medical Care. We wish him all the best for his retirement.”

Helen Giza, CEO and Chair of the Management Board, said: “Craig joins Fresenius Medical Care with many years of proven track record of operational management experience and successfully driving profitable business growth in different companies in the U.S. healthcare services industry. He will be a valuable member of my leadership team continuing our turnaround and transformation while leading Care Delivery into its next chapter. I would like to thank Bill for his many years of leadership and remarkable contributions to Fresenius Medical Care throughout his tenure with us, his passion for our patients and employees shines through in everything he does. I wish him well in his retirement.”

Craig Cordola said: “I am excited to join Fresenius Medical Care, the global leader in kidney care and leading healthcare brand across this industry. I cannot wait to partner with its leaders – and all of its team members – as we transform our organization to continue to serve patients and communities that suffer from renal disease.”
 

• Company-wide research offers novel pathways for enhancing kidney patient care using data-driven insights and real-world evidence

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the presentation of over 60 company-affiliated research abstracts at the American Society of Nephrology’s (ASN) Kidney Week 2023 taking place November 2-5 in Philadelphia.  

“The scientific and medical breadth of research presented this year highlights the power of Fresenius Medical Care’s global scope and scale in creating data-driven insights that have the potential to improve patient care and outcomes,” said Dr. Frank Maddux, Global Chief Medical Officer and Member of the Management Board for Fresenius Medical Care. “Our presentations cover key topics including advances in machine learning and artificial intelligence in kidney care, using big data and real-world evidence to drive insights, advancing home dialysis, and research around hemodiafiltration (HDF) and hemodialysis (HD) therapies. We look forward to sharing our insights at this year’s conference.”   
 
Scientific and medical experts from across Fresenius Medical Care will present research related to many important topics in kidney disease care. A link to all Fresenius Medical Care-affiliated presentations can be found on our company’s website: https://fmcna.com/ASN-2023/. Highlights of this year’s presentations for the medical congress include:

• Artificial Intelligence and Data Science: 
  • Impact of Nationwide Utilization of a Machine Learning Model to Identify Home Therapy Candidates (November 2, 10:00 AM – 12:00 PM): Education on a machine learning predictive model which identifies in-center hemodialysis patients who would be good candidates for home therapy.
  • Comparative Prognostic Accuracy of Vascular Access Flow and Artificial Intelligence (AI)-Based Arteriovenous Fistula (AVF) Failure Risk Score (November 3, 10:00 AM – 12:00 PM): Presenting a risk score which accurately and reproducibly predicts AVF failure within 3 months that may offer a cheaper and automated alternative to Qa measurement.
• Data-Driven Global Insights:
  • Apollo DB: Characteristics of a Global Dialysis Database Across Major World Regions (November 2, 10:00 AM – 12;00 PM): Capturing data from over 40 countries, Apollo DB is an anonymized dialysis database that combines and harmonizes data from a global provider for research and quality improvement activities.
  • Characteristics of Global Dialysis Data from Multiple Providers in the New MONitoring Dialysis Outcomes (MONDO) Dataset (November 2, 10:00 AM – 12:00 PM): Research captured from 20 years of longitudinal patient data contributed to the new MONDO dataset, the most robust global dialysis dataset in the world.
  • Creatinine Clearance Predicts Longitudinal Phosphate Levels Irrespective of Achieved Urea Kt/V: A Peritoneal Dialysis-MONDO Analysis (November 4, 10:00 AM – 12:00 PM): Experts present a study designed to evaluate if CrCl predicts longitudinal PO4 irrespective of achieved Kt/V.
• Hemodiafiltration (HDF) and Hemodialysis (HD) Research:
  • Relative Blood Volume Monitoring Using Crit-Line and Hospital Admissions: A Retrospective Analysis of over 25,000 Patients Across 330 Dialysis Clinics (November 2, 10:00 AM – 12:00 PM): Presenting a comparison of hospital admissions among Fresenius Kidney Care (FKC) clinics with high utilization of RBV and propensity score matched (PSM) clinics not using RBV.
  • Real-World Effectiveness of Hemodialysis Modalities (November 2, 10:00 AM – 12:00 PM): A late-breaking abstract that provides real world evidence demonstrating comparison of patients treated with hemodialysis vs hemodiafiltration.
  • Dialyzer Performance and Associations in Self-Reported Pruritis and Fatigue: Results from the eMPORA III Trial (November 3, 10:00 AM – 12:00 PM): eMPORA III was a multi-center crossover trial with 4-week randomized treatment periods comparing dialyzer performance (FX CorAL 600 vs two comparable high-flux dialyzers) in post-dilution online hemodiafiltration (HDF).
  • Psychometric Validation of the CONVINCE Inter- and Intradialytic Symptoms Questionnaire (November 3, 10:00 AM – 12:00 PM): The CONVINCE Scientific Committee and CONVINCE Investigators present the survey developed based on the KDQOL symptoms scale with an adapted recall period of 7 days for interdialytic symptoms and extended inter- and intradialytic (IDS) items based on literature review and patient interviews.

Fresenius sells its 70 percent stake in IDCQ CRP, a co-holding entity of the hospital Clínica Ricardo Palma in Lima, Peru. The stake is acquired by entities of the Verme family which already hold a stake in the hospital, together with other local investors. 

This exit from the hospital market in Peru is a further step to strengthening #FutureFresenius and is in line with the company's intention to divest certain assets announced earlier this year. Subject to antitrust review, the all-cash transaction is expected to close in the first quarter of 2024.

Fresenius sells its 70 percent stake in IDCQ CRP, a co-holding entity of the hospital Clínica Ricardo Palma in Lima, Peru. The stake is acquired by entities of the Verme family which already hold a stake in the hospital, together with other local investors. 

This exit from the hospital market in Peru is a further step to strengthening #FutureFresenius and is in line with the company's intention to divest certain assets announced earlier this year. Subject to antitrust review, the all-cash transaction is expected to close in the first quarter of 2024.

• Powerful Cloud-Based Data Asset to Drive Improvements in Care Quality and Patient Outcomes as the Largest Multinational, Longitudinal Database of its kind
• Achievement Part of Company’s Long-Term AI Strategy and Ongoing Digital Transformation Efforts 

Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the phase-one completion of the company’s first anonymized global dialysis dataset—coined the Apollo database project—the foundation of the company’s long-term AI aspirations. Intended to advance patient care quality and outcomes by making kidney disease care more personalized and precise, the database provides a highly sophisticated view into the clinical care provided to more than 540 thousand dialysis patients, the largest multinational, longitudinal database of its kind.

“Artificial intelligence is only as good as the data that powers it,” says Frank Maddux, MD, Global Chief Medical Officer and Member of the Management Board. “The Apollo database is not only helping advance our understanding of kidney disease and dialysis therapies through data-driven insights. It also provides data that is high quality, relevant and timely, three vital data attributes that are crucial to achieving AI aspirations at scale.” 

Phase one of the Apollo Database project harmonizes data from across the company’s global clinical systems into the cloud, aggregating data from 40 countries across 6 continents on more than 350 patient treatment parameters. It includes information from more than 540 thousand dialysis patients, more than 140 million dialysis treatments, and more than 34 million laboratory assessments. 

The database provides full anonymization of data and a streamlined pathway for global analytics all while adhering to the complex set of global, regional and local privacy requirements, including HIPAA and GDPR.

“The data created across Fresenius Medical Care’s global clinical footprint is unmatched in its breadth and depth, and is one of the company’s greatest competitive advantages,” said Stuart McGuigan, Global Chief Information Officer of Fresenius Medical Care. “Reimagining our digital infrastructure has been a key part of our organizational transformation, and the achievement of the Apollo Database project is an important benchmark in not just our digital transformation, but in our long-term AI strategy.” 

The Apollo Database project will be featured in numerous research presentations by Fresenius Medical Care experts at this year’s American Society of Nephrology Kidney Week conference—one of the world’s largest and most influential gatherings of kidney disease physicians and experts—happening November 2-5 in Philadelphia, Pennsylvania in the U.S. 

“Dialysis care generates a large amount of data that can be used for secondary purposes, but multinational datasets are scarce due to the fundamental need for adherence to varying complex data protection regulations around the world, as well as the challenges in harmonization of data from different clinical systems,” said Len Usvyat, PhD, Head of Clinical Advanced Analytics for Fresenius Medical Care. “This important data tool increases the speed and robustness of the company’s analytical capabilities and provides greater consistency in generating data-driven clinical insights. The knowledge gained from these efforts have the potential to improve not just the practice of medicine, but more importantly the quality of life for people with kidney disease.”

The project is coordinated by the Global Medical Office in collaboration with the company’s Digital Technology & Innovation, Care Delivery and Care Enablement teams. The project is already powering more than 15 clinical improvement projects, such as a global feasibility assessment of the expanded use of an Anemia Control Model, an artificial intelligence model being used in many countries to optimize use of erythropoietin stimulating agents and iron therapies in dialysis patients.