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Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, announced today that the U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to the Versi™PD Cycler System¹. This next-generation portable automated peritoneal dialysis system from Fresenius Medical Care North America is the lightest, smallest and quietest dialysis cycler in the United States.

As the leading provider of kidney care products in the U.S., Fresenius Medical Care is developing new, innovative technologies designed to accelerate the growth of home therapies by making home dialysis systems smarter, more intuitive and easier to use for people living with kidney failure. VersiPD is simple, quiet, portable and advanced. VersiPD is also designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients. 

Designed from the ground-up to enhance the patient experience, VersiPD will allow patients to enjoy restful sleep through its almost silent operation, fewer disruptive alarms and night mode. The cycler has the capability of more personalized prescription programming to meet the individual needs of a broad range of patients. VersiPD offers a large, intuitively designed touchscreen as well as embedded videos with audio guidance to assist patients step-by-step through setup and treatment. The cycler battery and custom cart facilitate mobility around the home, which can further improve the patient’s quality of life.

VersiPD is supported by the Kinexus™ Therapy Management Platform, a connected health system that aims to improve patient outcomes and nurses’ productivity through remote therapy monitoring and programming capabilities. The Kinexus platform is also available with the Liberty® Select Cycler and is designed to be fully compatible with the company’s future portfolio of home dialysis machines. Connected health is associated with reduced rates of hospitalization, technique failure and patient dropout, and an increased average patient length of stay on peritoneal dialysis.^2,3  

A limited rollout of VersiPD will begin this year, with wider availability planned in 2023 and beyond. The company also plans to roll out VersiPD in other regions around the world in the future.

¹ Previously known as Lilliput™ APD System
2 Chaudhuri S, Han H, Muchiutti C, et al. Remote Treatment Monitoring on Hospitalization and Technique Failure Rates in Peritoneal Dialysis Patients. Kidney360. 2020;1(3):191 LP - 202. doi:10.34067/KID.0000302019
³ Giles H, Ficociello L, Li Y, Ofsthun N, Kossmann R. Remote Patient Monitoring and Longevity on Peritoneal Dialysis [Abstract presented at 39th Annual Dialysis Conference]. Perit Dial Int. 2019;39(1_suppl): S4. doi:10.1177/089686081903901s01

Fresenius Kabi closed the acquisition announced in March of Ivenix, Inc. (“Ivenix”), a specialized infusion therapy company. Ivenix adds a next-generation infusion therapy platform for the significant U.S. market to Fresenius Kabi’s portfolio and provides the company with key capabilities in hospital connectivity. The combination of Ivenix’s leading hardware and software products with Fresenius Kabi’s offering in intravenous fluids and infusion devices will create a comprehensive and leading portfolio of premium products, forming a strong basis to enable sustainable growth in the high-value MedTech space. The purchase price is a combination of US$240 million upfront payment and milestone payments, strictly linked to the achievement of commercial and operating targets.

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The Fresenius Management SE Supervisory Board has unanimously appointed Sara Hennicken (41), currently Senior Vice President Global Treasury & Corporate Finance at Fresenius, to become the company’s new Chief Financial Officer as of September 1, 2022. She will succeed Rachel Empey (45), who joined the Management Board of Fresenius as CFO on August 1, 2017 and will leave the company at her own request at the end of August.

Sara Hennicken joined Fresenius in 2019. Previously, she spent 14 years in investment banking, including nine years at Deutsche Bank, lastly as Managing Director and Senior Client Executive in Corporate Finance Coverage before moving to Fresenius. Between 2005 and 2010 she worked for Citigroup in Frankfurt and London. Sara Hennicken studied economics in Germany and in the United States.

Rachel Empey said: “The good and trusting collaboration with my colleagues in the Management Board, and with my team has been personally fulfilling. Fresenius is a great company with outstanding prospects; together we have moved the company forward. The last years have been very intense, and challenging, yet also a great and very enriching experience. So, leaving was not an easy decision for me, but now I am looking forward to the next chapter of my life. I personally brought Sara Hennicken on board in 2019, and I know my duties and tasks are in good hands with her. I’m very happy for Sara and wish her a lot of luck, success and happiness in her new position, with the additional responsibility she will be taking on.”

Wolfgang Kirsch, Chairman of the Supervisory Board of Fresenius, said: “Rachel Empey further developed Fresenius’ finance department and made it ready for the future. During her time here – part of which was heavily impacted by the pandemic – she also set in motion important changes and improvements in her other areas of responsibility, such as IT. On behalf of the entire Supervisory Board, I want to thank her for all her contributions and hard work. In Sara Hennicken, we have an innovative, young and yet highly experienced financial expert from within the company who will assure continuity in this area but also bring in new ideas. She is ideally qualified for this position. Together with our CEO Stephan Sturm and her other Management Board colleagues, she will contribute to the future success of our healthcare group.”

Stephan Sturm, CEO of Fresenius, said: “I’m sorry that Rachel is leaving our company. Over these last years, we always worked well together, very collegially and with great trust, and I especially valued her as a sparring partner during our discussions about the company’s growth strategy. But, of course, I respect her decision, and wish Rachel all the very best for this new chapter of her life. At the same time, I am very much looking forward to working with Sara, who will enrich our management team with her personality, experience and ideas. We will be working together even more closely than before to create the optimal foundations for financing our healthy growth, and the sustainable success of our company.”

Sara Hennicken said: “I am very happy about the confidence and trust being placed in me, and greatly looking forward to the new tasks ahead. As a globally active healthcare company, Fresenius makes an important contribution to society with which I can very much identify. Over the past years, I’ve been able to realign my department and modernize our financing structure. The excellent group-wide collaboration with my colleagues has been especially valuable. In my new position I want to build on this, for the benefit of our company.”

Fresenius Kabi and the U.S. based company Cerus Corporation signed a new agreement for the production of systems for pathogen inactivation in blood components. The collaboration will help expanding access to pathogen-reduced blood components to patients. For many years, Cerus and Fresenius Kabi have collaborated regarding medical products specializing in pathogen inactivation for platelets and plasma. Since market launch of Cerus’ INTERCEPT systems, more than 11 million units have been in use worldwide.

Calcium Gluconate in Sodium Chloride Injection is now available in ready-to-administer non-DEHP, non-PVC containers, complementing the company’s existing vial presentations in the United States. Fresenius Kabi now has the broadest portfolio of Calcium Gluconate in Sodium Chloride Injection products available from any manufacturer in the United States.

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• First steps in executing Fresenius Kabi’s “Vision 2026” growth strategy
  • Acquisition of majority stake in mAbxience significantly enhances Fresenius Kabi’s presence in high-growth biopharmaceuticals market 
  • Ivenix adds next-generation infusion therapy platform to transform product offering 
• Combined, these acquisitions will meaningfully increase the company’s scale over the next years and accelerate the Group’s growth 
• Acquisitions combined are expected to be broadly neutral to Group cash earnings per share¹ in 2022 and accretive by 2023 
• Transactions expected to close by mid-2022

¹ earnings before amortization and integration costs

Stephan Sturm, CEO of Fresenius, said: “Through these acquisitions we are further strengthening and leveraging Fresenius Kabi's position, as both perfectly complement the company's growth businesses in biopharmaceuticals and medical technology. We will continue allocating capital in a targeted manner to rigorously pursue the recently presented growth strategy of our health care Group which has defined Fresenius Kabi as top priority. In this way, we are creating even better conditions for providing ever better medicine to ever more people. At the same time, we create meaningful value for our shareholders.”

Michael Sen, CEO of Fresenius Kabi, said: “Expanding our MedTech business and broadening our presence in Biopharmaceuticals are key to our Vision 2026 program. Today’s announcements fit squarely into our plans. With the acquisition of Ivenix, we add the next generation infusion therapy platform; we complement and strengthen our existing infusion therapy offering and we create a superior portfolio for the US market. With mAbxience, we are making a step-change in our biopharmaceuticals profile. This is a highly complementary transaction in terms of biologics pipeline, manufacturing capabilities and the business model. mAbxience is two businesses in one company. mAbxience and Ivenix as portfolio advancements are good for patients, good for healthcare providers and our company.”
 

Acquisition of a majority stake in mAbxience significantly enhances Fresenius Kabi’s presence in high-growth biopharmaceuticals market

• Delivers on core growth vector “Broaden Biopharma” of “Vision 2026”
• Provides access to expertise and capabilities in one of the fastest-growing areas of healthcare, positioning Fresenius Kabi for accelerated medium- and long-term growth
• Follows a convincing industrial logic focused on a global, end-to-end vertically integrated biopharmaceuticals footprint
• Creates a strong partnership with excellent growth potential in attractive biosimilars market
• Comprises high-growth biologics Contract Development and Manufacturing (“CDMO”) market with three state-of-the-art biologics manufacturing facilities in Spain and Argentina
• Provides access to a highly cost competitive biologics manufacturing capacity with significant cost synergies expected for Fresenius Kabi’s biosimilars portfolio

Fresenius Kabi announced today that it has agreed to acquire a stake of 55% of mAbxience Holding S.L. (”mAbxience”). The purchase price will be a combination of €495 million upfront payment and milestone payments, strictly tied to the achievement of commercial and development targets.  The contractual provisions also include a put / call option scheme regarding the current owners’ remaining shares in mAbxience (45%).

mAbxience is a leading international biopharmaceutical company, focused on the rapidly developing biosimilars market. The company was founded in 2010 by Dr. Hugo Sigman and Dr. Silvia Gold as the biotechnology division of Insud Pharma S.L. mAbxience has established itself as a leader in the development and manufacturing of biological drugs, with two commercialized biosimilar products (Rituximab and Bevacizumab) and a mid-single-digit number of molecules across immunology and oncology expected to be launched globally in the years 2024 to 2029. This is supported by internal R&D laboratories and state-of-the-art manufacturing facilities in Spain and Argentina. In addition to highly competitive production costs for the internal programs, the manufacturing platform allows mAbxience to offer third party biological CDMO services, including a recent contract with AstraZeneca to produce the drug substance for its COVID-19 vaccine in Latin America. The company currently employs approximately 600 staff and generated sales of approx. €255 million in 2021. 

The acquisition of a majority stake in mAbxience follows Fresenius Kabi’s recently unveiled Vision 2026 strategy, delivering on one of the core growth vectors – to “Broaden Biopharma” – by expanding along the value chain and further enhancing the existing Fresenius Kabi biosimilars pipeline. 

Fresenius Kabi expects, through its in-house biosimilars programs and through its investment in mAbxience, to capture an overproportionate share of the underlying rapid growth in the biopharmaceutical market. Fresenius Kabi’s footprint in biopharmaceuticals will be significantly strengthened by broadening its biosimilars portfolio and by gaining access to the distinctive manufacturing capabilities of mAbxience. It will also allow Fresenius Kabi to provide end-to-end integrated biopharmaceutical solutions for customers from its state-of-the-art facilities.

mAbxience operates three state-of-the-art facilities for the production of biologic drug substance. This addresses a critical gap in Fresenius Kabi’s value chain, adding flexible, single-use biologic drug substance capacity that can be leveraged to provide competitive cost of production for the enlarged biosimilars portfolio. This manufacturing capability also offers end-to-end integrated biopharmaceutical solutions for customers and thus establishes a strategic foothold for Fresenius Kabi in the fast-growing biologic CDMO sector, complementing the existing small molecule API and fill & finish operations.

Once completed, the transaction is expected to deliver material operating and cost synergies for Fresenius Kabi, primarily driven by leveraging mAbxience’s manufacturing capabilities for Fresenius Kabi’s existing biosimilars business. 

The transaction remains subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022.
 

Ivenix strengthens Fresenius Kabi’s MedTech business and accelerates growth

• Delivers on core growth vector “Expand MedTech” of Vision 2026
• Provides next-generation infusion therapy platform for U.S. market
• Complements Fresenius Kabi’s global infusion therapy offering
• Provides Fresenius Kabi with key capabilities in hospital connectivity and creates new options for growth of MedTech business
• Significant scale and growth synergies expected

Fresenius Kabi announced today that it has agreed to acquire Ivenix, Inc. („Ivenix“), a specialized infusion therapy company. The purchase price will be a combination of US$240 million upfront payment and milestone payments, strictly linked to the achievement of commercial and operating targets.

Ivenix is a privately held company based in North Andover, Massachusetts, USA. The company has developed the technologically most advanced infusion system including a large volume pump (“LVP”) with administration sets, infusion management software tools, applications and analytics to inform care and advance efficiency. The Ivenix Infusion System’s innovative design and architecture sets a new standard in infusion safety, simplicity and interoperability. The system is centred around the patient and clinician and is designed to reduce infusion-related errors and drive down the total cost of ownership. After having received the U.S. Food and Drug Administration’s (FDA) approval, the Ivenix Infusion System was successfully launched in late 2021.

Ivenix’ Infusion System provides access to attractive growth potential for Fresenius Kabi in the large and growing infusion therapy market. The combination of Ivenix’ leading hardware and software products with Fresenius Kabi’s offerings in intravenous fluids and infusion devices will create a comprehensive and leading portfolio of premium products, forming a strong basis to enable sustainable growth in the high-value MedTech space.  

The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022. 

Financing and implications on Group financials

mAbxience is expected to be accretive to Group cash earnings per share (earnings before amortization and integration costs) right after closing. Ivenix is expected to be neutral to Group cash earnings per share in 2025 and accretive from 2026 onwards. 

Combined, these acquisitions are expected to be broadly neutral to Group cash earnings per share in 2022 and accretive as of 2023. 

The transactions are currently expected to be financed by cash flow and available liquidity. 

Conference Call 

A telephone conference on the acquisition of a majority stake in mAbxience Holding S.L. and the acquisition of Ivenix, Inc. will be held on March 31, 2022 at 1:30 p.m. CEST (7:30 a.m. EDT). 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.

The European Commission (EC) has granted Fresenius Kabi the marketing authorization for Stimufend®, the company’s pegfilgrastim biosimilar, for all approved indications of the reference medicine. Stimufend® stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy. This is the company’s first approved biosimilar molecule used in oncology and its second biosimilar approved in Europe, expanding its autoimmune disease and oncology focused product portfolio.