Biotest shares rise after FDA approval, sales rise 6% in 2024
Biotest AG (ETR: BIOG_p) reported a 6% increase in revenue in fiscal 2024 to €726.2 million, driven by strong demand for its immunoglobulin products, in particular Yimmugo®, which was approved by the US Food and Drug Administration (FDA) in June 2024.
The approval also certified Biotest's manufacturing facility, paving the way for expansion into the US market in 2025.
EBIT was €94.5 million, at the top of the forecast range, but down from €143.5 million in the previous year. The decrease was mainly due to lower revenue from technology transfer and development services to Grifols, S.A. However, adjusted EBIT, excluding one-off effects, improved from €9.8 million in 2023 to €64.5 million in 2024.
Earnings before tax fell to €46.5 million from €106.3 million the previous year, while net profit fell from €127 million in 2023 to €26.4 million in 2024.
Despite the decline in earnings, cash flow from operations improved, rising to €60.9 million from negative €2.7 million the previous year, thanks to better working capital management.
Following FDA approval, Biotest has ramped up production of Yimmugo® in preparation for a 2025 US market launch. The company has entered into a long-term agreement with Kedrion Biopharma for exclusive marketing and distribution of Yimmugo® in the US, which is expected to generate over $1 billion in revenue over the next seven years.
Biotest has also completed a Phase III AdFirst clinical trial for its new fibrinogen product, manufactured at Dreieich. The company has applied for approval in key European markets and the United States, targeting the treatment of acquired and congenital fibrinogen deficiency, with a decision expected by the end of 2025.
For 2025, Biotest forecasts a mid-single-digit percentage decline in revenue, primarily due to a significant reduction in revenue from development and technology transfer services to Grifols, S.A., which contributed €123.1 million to revenue in 2024. The company expects an operating loss (EBIT) of -€55 million to -€75 million and a return on capital employed (ROCE) of -3% to -7%. Cash flow from operations is expected to be negative in the low three-digit million euro range.