Biotest: FDA Approval and Strong Financial Figures Drive Growth

  • The company reported strong financial figures and expects further growth through strategic partnerships.
  • Biotest receives FDA approval for Yimmugo and plans market entry in the USA for 2025.

Eulerpool News·

Biotest, a leading company in the field of immunotherapies, has reached a significant milestone: the FDA approval for Yimmugo opens the company to the U.S. market, considered the largest single market for immunoglobulins. Peter Janssen, Chief Operations Officer, announced that market entry in the USA is planned for the first quarter of 2025. This step is supported by a long-term agreement with Kedrion from Italy, guaranteeing a minimum purchase volume over seven years and promising revenue of over one billion US dollars. In the first half of 2024, Biotest was able to increase its revenue to 372 million euros, representing a 35% increase compared to the previous year. Ainhoa Zubiaga, Chief Financial Officer, also reported an increase in consolidated EBIT to 78.4 million euros and an EBITDA of 100 million euros, indicating significant growth. Additionally, the company was able to reduce its net debt by 72 million euros. Regarding the product pipeline, Biotest is making progress in two phase III studies for Trimodulin in the treatment of community-acquired pneumonia. For the product Fibrinogen, the company plans to submit market approval applications in the USA and Europe by the end of the year, following the successful completion of phase III studies. Strategic partnerships form another cornerstone of Biotest’s expansion strategy. Peter Janssen emphasized strengthening collaboration with Grifols and the strategic agreement with Kedrion, which are essential for market expansion and sustainable growth. For the remainder of 2024, Biotest expects revenue growth in the upper single-digit percentage range, driven by the commissioning of the Biotest Next Level production facility. The company forecasts an operating result between 80 million and 100 million euros, as well as a significantly higher positive cash flow from operating activities compared to the previous year.
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