Biotest Reports 6% Sales Growth in 2024, FDA Approves Yimmugo for US Market
Key Insights
Biotest AG achieved €726.2 million in sales for 2024, a 6.1% increase driven primarily by strong performance of Intratect and Yimmugo (search), with EBIT reaching €94.5 million at the upper end of forecast range.
The FDA approved Yimmugo (search) in June 2024 and certified Biotest's production facility, enabling the company to secure a long-term distribution agreement with Kedrion Biopharma (search) expected to generate over $1 billion in the next seven years.
Biotest successfully completed the AdFirst Phase III trial and submitted marketing authorization applications for its new fibrinogen preparation in key European markets and to the FDA, with approval decisions expected by the end of 2025.
Biotest AG reported a 6.1% increase in sales for the financial year 2024, reaching €726.2 million compared to €684.6 million in the previous year. The growth was primarily driven by increased sales of Intratect® and Yimmugo (search)®, the company's intravenous immunoglobulin products.
The company's EBIT for 2024 amounted to €94.5 million, achieving the upper end of its forecast range despite a decrease from €143.5 million in the previous year. This decline was primarily attributed to lower earnings from technology disclosure and development services for Grifols, S.A., which fell to €89.3 million from €158.2 million in the prior year.
Notably, adjusted EBIT improved significantly to €64.5 million from €9.8 million in the previous year, demonstrating stronger core business performance. The Biotest Group's profit (EAT) for 2024 was €26.4 million, down from €127.0 million in 2023.
FDA Approval of Yimmugo Marks Major Milestone
In a significant development for the company, Biotest received approval from the U.S. Food and Drug Administration (FDA) for Yimmugo (search)® in June 2024. This approval included certification of the corresponding production facility, making Yimmugo® the first product from Dreieich to be approved in the United States, which represents the world's largest single market for plasma derivatives.
Yimmugo (search)®, sales of which rose by €34.9 million to €62.1 million in 2024, is the first commercial preparation produced using an innovative manufacturing process at the Biotest Next Level production facility. Following FDA approval, Biotest immediately began producing quantities required for the U.S. market launch planned for 2025.
"The FDA approval of Yimmugo (search) represents a transformative milestone for Biotest as we enter the U.S. market with our innovative immunoglobulin therapy," said a Biotest executive. "This achievement validates our manufacturing capabilities and positions us for significant growth in the world's largest healthcare market."
Strategic Partnership with Kedrion Biopharma
For the U.S. market launch in 2025, Biotest has concluded a long-term agreement with Kedrion Biopharma (search) for the complete marketing and distribution of Yimmugo (search)® in the United States. This partnership is expected to generate sales exceeding one billion U.S. dollars over the next seven years, making a significant contribution to increasing the company's profitability.
Fibrinogen Development Advances
In another important development, Biotest successfully completed the AdFirst Phase III trial for its fibrinogen product in 2024. Based on these results, the company has submitted marketing authorization applications for this new preparation in key European markets and to the FDA.
The fibrinogen product, which is manufactured in Dreieich, aims to address the high medical demand for additional fibrinogen in the treatment of acquired and congenital fibrinogen deficiency (search). Biotest expects decisions on these approval applications by the end of 2025, potentially laying the foundation for further growth.
Financial Performance Details
Cash flow from operating activities showed marked improvement, reaching €60.9 million compared to a negative €2.7 million in the previous year. This positive development was primarily due to significantly improved cash flow from changes in working capital.
The return on capital employed (ROCE) for 2024 was 7.9%, down from 12.3% in 2023, reflecting the decline in EBIT while capital employed remained at similar levels to the previous year.
Outlook for 2025
Looking ahead, Biotest's Management Board has provided a cautious outlook for 2025, projecting a mid-single-digit percentage decline in sales compared to 2024. This forecast reflects the expected reduction in revenue from technology disclosure and development services for Grifols, S.A., which positively influenced 2024 results with €123.1 million.
The Executive Board anticipates an operating result (EBIT) in the range of €-55 million to €-75 million for 2025, with ROCE expected to be between -3% and -7%. Cash flow from operating activities is projected to be in the low negative triple-digit million range, following the operating performance and development of net working capital.
Despite these near-term challenges, the company remains optimistic about its long-term growth prospects, particularly with the upcoming U.S. launch of Yimmugo (search)® and potential approval of its fibrinogen product.
About Biotest
Biotest is a provider of biological therapeutics derived from human plasma, specializing in clinical immunology, hematology, and intensive care medicine. The company develops and markets immunoglobulins, coagulation factors, and albumin based on human blood plasma for diseases of the immune and hematopoietic systems.
With more than 2,400 employees worldwide, Biotest has been part of the Grifols Group, based in Barcelona, Spain, since May 2022. The company's ordinary and preference shares are listed in the Prime Standard on the German stock exchange.