Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).

The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.

This BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.

Prolia® and Xgeva® are registered trademarks of Amgen Inc.
 

Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).

The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.

This BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.

Prolia® and Xgeva® are registered trademarks of Amgen Inc.

 

At today’s Annual General Meeting in Frankfurt am Main, the shareholders of Fresenius SE & Co. KGaA approved the proposals of the General Partner and the Supervisory Board by a large majority.

Wolfgang Kirsch, Chairman of the Supervisory Board, thanked the Management Board and emphasized Fresenius’ strong performance in extremely challenging geopolitical times. “Against this backdrop, Fresenius has performed well as a leading healthcare company compared to the competition and has improved significantly in operational terms.” He added that the #FutureFresenius program is strengthening Fresenius sustainably in the interests of all stakeholders. “The new Management Board team under the leadership of Michael Sen brings experience and complementary skills, team spirit and abilities, which will allow us to achieve the ambitious corporate goals and successfully implement #FutureFresenius,” said Kirsch.

CEO Michael Sen thanked the shareholders for supporting the #FutureFresenius journey, as well as the members of the Supervisory Board and Chairman Wolfgang Kirsch for their excellent cooperation. “We have successfully completed the first phases of #FutureFresenius and regained trust. We shall now tackle the remaining phases with motivation and optimism,” he stressed. 

A large majority of 99.84% of shareholders voted in favor of approving the annual financial statements. The shareholders approved the Compensation Report for the 2023 fiscal year by 93.06%. Large majorities of 96.48% and 95.90% respectively approved the actions of the Management Board and the Supervisory Board in 2023.

At the Annual General Meeting of Fresenius SE & Co. KGaA, 72.65% of the registered capital was represented.

• Fresenius is simpler, stronger, and more innovative due to #FutureFresenius
• Following a strong first quarter and higher expectations for the year as a whole, outlook improved at the beginning of May 
• First in-person Annual General Meeting since 2019
• Fresenius’ new brand identity reflects its restructuring

After an excellent start to the 2024 fiscal year, DAX 40 company Fresenius is looking to the future with confidence. “Our aim for the coming years is to now establish Fresenius as an economically successful, innovative healthcare company focused on modern therapies,” said CEO Michael Sen at this year’s Annual General Meeting on Friday in Frankfurt am Main. 

“2023 was a year of change and new beginnings here at Fresenius. We introduced our #FutureFresenius program to restructure our company, sharpen our focus, and continue successfully developing our company. We now want to tap into this positive momentum,” Sen stressed. The structural simplification, including the deconsolidation of Fresenius Medical Care and the exit from Vamed, as well as the focus on Fresenius Kabi and Fresenius Helios, is increasingly paying off. Both core businesses are growing profitably in highly attractive markets and were able to further increase their momentum in the first quarter of 2024. 

With the presentation of the financial figures for the first quarter, Fresenius raised the Group’s outlook¹ for the current fiscal year last week and now expects organic revenue growth of 4–7% and currency-adjusted EBIT growth of 6–10%.

¹ The adjustment of the Group outlook reflects the fact that the forecast now excludes Fresenius Vamed, i.e. it is exclusively for the operating companies Fresenius Kabi and Fresenius Helios.

“We have regained our strength at just the right time. The healthcare industry is currently growing robustly and reliably. Indeed, it is one of the most attractive sectors,” Sen said. To this end, Fresenius is focusing its business on three platforms, which together create a market potential of up to €1 trillion: (Bio)Pharma, which includes chemical and biological drugs and clinical nutrition, MedTech, i.e. medical technology, which increasingly involves a combination of hardware and software, and Care Provision, i.e. medical care, whether in-patient or outpatient, or at home. Sen emphasized: “We are close to the patients. And this is exactly what sets us apart from purely pharma and medtech companies. And also from tech companies based in Silicon Valley.”

This proximity to the patients is also demonstrated by innovative products that enhance the medical quality and efficiency of care. Fresenius Kabi recently achieved two major milestones with the market launch of the biosimilar Tyenne for the treatment of inflammatory and autoimmune diseases in the EU and the USA. In Fresenius Helios hospitals, highly precise and tissue-friendly surgical robots assist in minimally invasive procedures. These robots are operated by a doctor by hand control and pedal. A total of 20 Da Vinci surgical robots are currently used at Helios hospitals in Germany.

Fresenius introduced a fresh and modernized brand identity at the Annual General Meeting. With its new slogan “Committed to Life”, Fresenius aims to be recognized as a leading healthcare company offering world-class therapies and improving people’s lives.

This year’s Annual General Meeting is the first in-person Fresenius shareholder meeting since 2019. Several hundred shareholders were expected to attend the Annual General Meeting at Messe Frankfurt.

• Vamed’s operations in Austria to be sold to an Austrian consortium of construction companies, Porr and Strabag.
• Vamed’s hospital services unit to be transferred to the Fresenius Group. 
• Vamed's international project business to gradually be scaled back in an orderly manner. Current project contracts are to be fulfilled.  
• The exit from Vamed, including the announced divestment of the rehabilitation business, is a further milestone on the path to #FutureFresenius and completes the strategic portfolio restructuring.
• Fresenius has significantly reduced its complexity and underlined its position as a leading therapy-focused company.

Following the announcement of the sale of Vamed’s rehabilitation business, the global healthcare group Fresenius has initiated a structured exit from its Investment Company Vamed. An Austrian consortium of construction companies Porr and Strabag has agreed to acquire Vamed’s activities in its Austrian home market for a total purchase price of 90 million Euros. The transaction includes Vamed’s entities responsible for the technical management of the Vienna General Hospital (AKH Wien), the Austrian project business that is part of Vamed’s Health Tech Engineering segment and shares in several spas throughout Austria. The planned transaction is subject to regulatory approvals and customary conditions.

Vamed’s High-End Services (HES) business unit, which provides services for Fresenius Helios and other hospitals, will be transferred to Fresenius. HES generates around half of its revenue through its provision of services to Helios hospitals. It offers facility and medical technology management for a total of more than 840 hospitals. HES is a stable business with good growth prospects and accounts for around 30% of Vamed's revenue. The profitability of HES is in the mid-single-digit percentage range.

The Health Tech Engineering segment, which is responsible for the international project business and accounts for around 15% of Vamed's revenue, will gradually be scaled back in an orderly manner. The process should largely be completed by 2026. Until then, the business will be reported as a special item outside Fresenius' core business. Current project contracts will be fulfilled. 

The divestments lead to non-cash special items of around € 0.6 billion. Due to the exit from the project business, a high triple-digit-million Euro amount of special items are expected, which are spread over the next few years and mostly cash effective.

As of Q2 2024, Vamed will no longer be a reporting segment of Fresenius. In addition to reducing complexity, this step is expected to improve the Group's profitability by more than 50 basis points. It will also reduce net debt and increase the Group's return on invested capital (ROIC). Last but not least, the transparency and quality of earnings will be significantly enhanced.  

“We have found a holistic and viable solution for the Vamed businesses, creating good prospects for the future. It is the best outcome for patients, for Vamed, and for Fresenius. With the exit from Vamed, our strategic portfolio restructuring has been completed as planned. Fresenius is already a simpler, stronger, and more innovative company due to the consistent implementation of #FutureFresenius. We now have even more opportunities to provide world-class therapies and improve people’s health,” said Fresenius CEO Michael Sen.

Dr. Michael Moser, the member of the Fresenius Management Board among others responsible for the Vamed business, added: “We are pleased that Vamed’s High-End Services business is joining Fresenius. We have found a very good solution for both the rehabilitation business with PAI and the Austrian project business with the Austrian owners Porr and Strabag. This enables us to create long-term growth opportunities. We are now looking for fair solutions for the employees affected by the gradual ramp-down of our project business outside of Austria.” 

After exiting Vamed, Fresenius will consist of the two Operating Companies Fresenius Kabi and Fresenius Helios (each with 100% ownership share) and the Investment Company Fresenius Medical Care (32% ownership share).