Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Biotest AG (WBO:BIO3, Financial) successfully finalized the Phase III trial for acquired fibrinogen deficiency and plans to submit marketing authorization applications in the USA and Europe by the end of the financial year.
- The company achieved a significant milestone with the US FDA approval of their immunoglobulin product, Yimmugo, and plans to launch it in the US market in the first quarter of 2025.
- Biotest AG entered into a long-term agreement with Kedrion, ensuring a minimum purchase volume of Yimmugo over seven years, potentially generating over USD 1 billion in sales.
- The company reported a 35% revenue growth in the first half of 2024, reaching EUR 372 million, with significant contributions from products like Pentaglobin and Cytotect.
- Biotest AG reduced its net debt by EUR 72 million and repaid a significant loan tranche, improving its financial stability.
Negative Points
- Revenue in the European region decreased by 3.4% due to lower volumes of immunoglobulin and other preparations.
- The company experienced a decrease in current financial liabilities by EUR 65.5 million, primarily due to loan repayments, which could impact liquidity.
- There was a decrease in cash and cash equivalents by EUR 42 million, reflecting potential cash flow challenges.
- Biotest AG faced technical problems at the start of the earnings call, indicating potential operational inefficiencies.
- The company reported a decrease in toll manufacturing revenues and a slight decrease in noncurrent assets, which could affect future growth prospects.
Q & A Highlights
Q: Can you provide more details on the recent FDA approval and its impact on Biotest's market strategy?
A: Peter Janssen, Chief Operations Officer, explained that the FDA approval of Yimmugo marks a significant milestone, granting Biotest access to the U.S. market, the largest single market for immunoglobulin. The company plans to launch in the U.S. in the first quarter of 2025, supported by a long-term agreement with Kedrion in Italy, which ensures a minimum purchase volume over seven years, translating to over USD 1 billion in sales.
Q: What are the financial highlights for the first half of 2024?
A: Ainhoa Zubiaga, Chief Financial Officer, reported that Biotest generated revenues of EUR 372 million, a 35% increase compared to the previous year. Consolidated EBIT rose to EUR 78.4 million, and EBITDA reached EUR 100 million, reflecting significant growth. The company also reduced its net debt by EUR 72 million.
Q: How is Biotest progressing with its product pipeline, particularly Trimodulin and Fibrinogen?
A: Peter Janssen highlighted that Biotest is advancing with two Phase III trials for Trimodulin in community-acquired pneumonia. For Fibrinogen, the company plans to submit marketing authorization applications in the U.S. and Europe by the end of the year, following successful Phase III trials.
Q: Can you elaborate on the strategic partnerships Biotest is pursuing?
A: Peter Janssen mentioned that Biotest is strengthening its partnership with Grifols and has entered a strategic agreement with Kedrion for the U.S. market. These partnerships are crucial for expanding market reach and ensuring sustainable growth.
Q: What is the outlook for Biotest for the remainder of 2024?
A: Ainhoa Zubiaga confirmed that Biotest expects upper single-digit percentage revenue growth for the year, driven by the ramp-up of the Biotest Next Level production facility. The company anticipates an operating result between EUR 80 million to EUR 100 million and a significantly higher positive cash flow from operating activities compared to the previous year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
