Fresenius Acquires Remaining 45% Stake in mAbxience for Up to €750 Million, Securing Full Ownership of Biosimilars Platform

Fresenius Acquires Remaining 45% of mAbxience for Up to €750 Million, Taking Full Ownership of Biosimilars Platform

Fresenius SE & Co. KGaA has completed the acquisition of the remaining 45% stake in mAbxience Holding S.L., strengthening its position in the global biopharmaceutical and biosimilars market. The transaction gives Fresenius full ownership of mAbxience, a biopharmaceutical company focused on the development and manufacturing of biosimilar monoclonal antibodies and contract development and manufacturing services.

Fresenius acquired the remaining stake from Insud Pharma S.L. and Invim Corporativo, S.L. for total consideration of up to €750 million. The transaction includes a contingent payment of €50 million linked to site approvals.

The agreement was signed and completed on September 30, 2026, and no regulatory approvals were required to complete the transaction.

The acquisition marks the completion of a partnership that began in August 2022, when Fresenius acquired a 55% majority stake in mAbxience. Since that investment, Fresenius has controlled and consolidated the business. With the purchase of the remaining shares, mAbxience is now fully owned by Fresenius and integrated within Fresenius Kabi’s Biopharma business.

The transaction gives Fresenius complete ownership of a biosimilars platform positioned across research, development, manufacturing, regulatory activities and commercialization. It also provides the company with greater control over investment decisions, production capacity, product launches and future partnerships.

Expanding Fresenius’ Biopharma Strategy

The acquisition represents another step in Fresenius’ strategy to expand its biopharmaceutical capabilities and strengthen its position in biosimilars.

Biosimilars are biological medicines that are highly similar to an already approved biological reference product and can provide additional treatment options following the loss of exclusivity of originator biologics. The sector is expected to experience substantial growth as a large number of biologic medicines approach or pass the end of their exclusivity periods.

Fresenius said the biosimilars market is expected to grow approximately sixfold by 2035, reaching more than €180 billion. The company views this market expansion as an opportunity to leverage mAbxience’s development and manufacturing capabilities alongside Fresenius Kabi’s regulatory and commercial infrastructure.

Full ownership allows Fresenius to capture the complete economic benefit of mAbxience while gaining greater strategic flexibility. The company can determine how to allocate capital toward manufacturing capacity, evaluate future biosimilar opportunities and pursue licensing partnerships based on its own strategic priorities.

The transaction also brings the mAbxience platform more closely together with Fresenius Kabi’s existing capabilities, creating an integrated structure spanning the development of products through their eventual commercialization.

Building on a Four-Year Partnership

Fresenius’ relationship with mAbxience began with the majority investment in 2022. At the time, the transaction gave Fresenius access to an established biosimilars platform while allowing the company to manage its exposure to the developing market.

Since then, mAbxience has progressed through multiple development, manufacturing, technology-transfer and regulatory milestones.

Fresenius Chief Executive Officer Michael Sen said completing the acquisition represents another milestone in the company’s efforts to build a vertically integrated biopharma business at scale.

According to Sen, Fresenius initially entered mAbxience through a majority investment to gain access to the platform while managing risk as the biosimilars market continued to develop. Since the initial investment, the market has expanded and mAbxience has delivered against its development and business objectives.

Full ownership now gives Fresenius greater control over cost management, manufacturing capacity and launch timing while allowing the company to retain the full economic benefit of the business.

The transaction also aligns with Fresenius’ capital allocation priorities under its #FutureFresenius framework.

mAbxience’s Global Manufacturing Network

mAbxience operates a global biopharmaceutical manufacturing network spanning Spain and Latin America.

The company operates three multi-product drug substance facilities equipped to support its biopharmaceutical activities. These facilities provide manufacturing capabilities for mAbxience’s own biosimilar programs as well as services for external partners.

The company employs more than 1,300 people and has developed expertise in biosimilar monoclonal antibodies.

In addition to developing its own portfolio, mAbxience provides contract development and manufacturing services to pharmaceutical and biotechnology partners. This combination of proprietary development and contract services provides the company with multiple avenues for utilizing its scientific and manufacturing capabilities.

In 2025, mAbxience generated more than €320 million in revenue. Its EBITDA margin was accretive to the overall Fresenius Kabi margin, according to Fresenius.

The company currently has four products on the market and eight additional candidates in development.

With Fresenius Kabi’s development, regulatory and commercial capabilities added to mAbxience’s platform, Fresenius said the combined business covers the full value chain from laboratory development through to patients.

Greater Control Over Manufacturing and Launches

Full ownership provides Fresenius with increased control over the strategic and operational development of mAbxience.

Manufacturing capacity is particularly important in the biosimilars market because successful commercialization requires the ability to produce biological medicines consistently and at scale. Greater ownership allows Fresenius to make investment decisions concerning production facilities and capacity based on the broader requirements of its Biopharma business.

The transaction also gives Fresenius greater control over product launch timing. As biologic medicines lose exclusivity, companies developing biosimilars must coordinate regulatory approvals, manufacturing readiness and commercial strategies.

By bringing mAbxience fully into its ownership structure, Fresenius can coordinate these activities more closely with its broader biopharma strategy.

The company also expects full ownership to provide additional flexibility when evaluating licensing and partnership opportunities.

Continued Leadership at mAbxience

Jürgen Van Broeck, Chief Executive Officer of mAbxience, will continue to lead the business following the completion of the acquisition.

Van Broeck will report to Dr. Sang-Jin Pak, President of Biopharma at Fresenius.

Commenting on the transaction, Van Broeck emphasized the role of mAbxience’s employees and partners in building the company since its establishment.

He also recognized Insud Pharma for its support during the company’s development over the past decade.

According to Van Broeck, the partnership between mAbxience and Fresenius since 2022 demonstrated the value of combining the organizations’ people, expertise and capabilities. Full ownership represents the next stage of that relationship and provides a foundation for further innovation and growth.

The company intends to retain the entrepreneurial culture, scientific expertise and patient-focused approach that have contributed to mAbxience’s development.

Financial Structure of the Transaction

Fresenius will pay up to €750 million in cash for the remaining 45% interest in mAbxience.

The consideration includes a €50 million contingent payment that is dependent on site approvals.

Fresenius said the transaction will be funded through available liquidity and operating cash flow, meaning no new financing was required to complete the acquisition.

The company expects the transaction to increase net debt to EBITDA by approximately 20 basis points. Despite the increase, Fresenius expects its full-year leverage to remain toward the lower end of its self-imposed target corridor of 2.5 times to 3.0 times.

The acquisition also settles the put option liability associated with the 45% non-controlling interest that had previously been recognized on Fresenius’ consolidated balance sheet.

Under International Financial Reporting Standards, the acquisition of a non-controlling interest is accounted for as an equity transaction. Fresenius said no goodwill will arise from the transaction.

The company expects the acquisition to be immediately accretive to Group core earnings per share.

Expected Impact on Returns

Fresenius also expects the acquisition to further improve its return on invested capital.

The company said the investment is expected to improve ROIC, which was already above Fresenius’ cost of capital following the integration of mAbxience.

This expectation is consistent with Fresenius’ broader capital allocation criteria, which emphasize investments capable of supporting sustainable returns while maintaining balance sheet discipline.

The company also highlighted its continued focus on maintaining a strong balance sheet and reducing leverage.

Fresenius currently has credit ratings of BBB with a positive outlook from S&P, Baa3 with a stable outlook from Moody’s and BBB- with a positive outlook from Fitch.

No Change to 2026 Guidance

Despite completing the €750 million transaction, Fresenius does not expect to change its full-year 2026 financial guidance.

The company also maintained its 2030 Biopharma ambition of approximately doubling revenue compared with 2025 while achieving an EBIT margin of around 20%.

The unchanged guidance indicates that Fresenius views the mAbxience acquisition as consistent with its existing financial framework and long-term Biopharma objectives.

The company intends to pursue further growth of the platform while maintaining its broader financial priorities.

Positioning for the Next Wave of Biosimilars

The acquisition comes as the biopharmaceutical industry approaches a significant period of patent and exclusivity expirations involving major biologic medicines.

As more biologics lose exclusivity, biosimilars can provide pharmaceutical companies with opportunities to introduce alternative versions of established biological therapies.

For Fresenius, full ownership of mAbxience provides a platform from which it can pursue additional opportunities in this expanding market.

The company can combine mAbxience’s scientific and manufacturing expertise with Fresenius Kabi’s regulatory and commercial infrastructure. This integrated model may support the development of new products, manufacturing expansion and commercialization across multiple markets.

Fresenius also expects the structure to support supply resilience and quality as the business expands.

Strengthening the Full Value Chain

A key feature of the transaction is the ability to combine capabilities across the entire biopharmaceutical value chain.

mAbxience brings expertise in biosimilar development, drug substance manufacturing and contract development and manufacturing. Fresenius Kabi contributes development, regulatory and commercial capabilities.

Together, these activities create a vertically integrated platform extending from laboratory research and development through manufacturing, regulatory processes and commercialization.

This structure gives Fresenius greater visibility and control across different stages of the product lifecycle.

It also provides a foundation for future investment as the company evaluates opportunities to expand its biosimilars pipeline and manufacturing footprint.

A New Chapter for mAbxience

With the transaction completed, mAbxience enters its next phase as a wholly owned Fresenius business.

The acquisition strengthens Fresenius Kabi’s Biopharma operations and gives Fresenius full economic ownership of a business that has already demonstrated commercial and operational progress under the company’s majority ownership.

For mAbxience, the transaction preserves its existing leadership while providing access to the broader capabilities of Fresenius.

The company’s four marketed products, eight development candidates, manufacturing network and more than 1,300 employees provide the foundation for continued expansion.

As the global biosimilars market develops, Fresenius plans to use the combined capabilities of mAbxience and Fresenius Kabi to pursue additional growth opportunities while maintaining its financial framework.

The acquisition of the remaining 45% stake therefore represents more than a change in ownership structure. It brings the mAbxience platform fully into Fresenius, giving the company greater control over investment, manufacturing, development and commercialization decisions.

With no change to its 2026 guidance or 2030 Biopharma ambition, Fresenius is positioning the newly wholly owned platform as an important component of its longer-term strategy to expand its biopharmaceutical business and participate in the growing global market for biosimilar medicines.

Source link: https://www.fresenius.com/

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