In This Article:
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Revenue: Decrease compared to 2023, expected and within range.
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EBITDA: Decrease to minus EUR17.7 million, expected due to reduced revenues and increased R&D and SG&A expenses.
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Adjusted EBITDA: Significant improvement from minus 18 to plus 3 million compared to last year.
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Royalties from FYB201: Increased from EUR2.3 million in 2023 to EUR6 million in 2024.
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Loan Repayment: EUR22.3 million received from BioAg, contributing to cash flow.
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Equity Result: EUR20.6 million from BioAg's net profit performance.
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Cash and Cash Equivalents: EUR33.8 million, increased from the beginning of the year.
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Capital Expenditure: Significant investment of almost EUR25 million in FYB206 activities.
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Equity Ratio: Approximately 60%, indicating a strong financial position.
Release Date: November 28, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Formycon AG (XTER:FYB) achieved two FDA approvals and two positive CHMP opinions for its biosimilars, FYB202 and FYB203, in a shorter time than the industry average.
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The company successfully included the first patient in its oncology program for the Keytruda biosimilar FYB206, positioning itself among the frontrunners in this market.
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Formycon AG has launched its FYB201 Lucentis biosimilar in 20 countries, achieving a market share of over 40% in the US and even higher in the UK.
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The company is on track to launch its Stelara biosimilar FYB202 in the US by February 2025, following FDA and European Commission approvals.
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Formycon AG's financial performance is strong, with a significant increase in royalties from FYB201 and a positive impact from its equity result, reflecting successful commercialization efforts.
Negative Points
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Formycon AG experienced a decrease in revenue compared to 2023, attributed to reduced compensation work and milestone payments.
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The company reported a negative EBITDA of EUR17.7 million, driven by reduced revenues and increased R&D and SG&A expenses.
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There is ongoing legal uncertainty with Regeneron regarding the Eylea biosimilar, which could impact market entry timelines.
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Market adoption of the FYB201 biosimilar has been slower in some regions, prompting plans to introduce a prefilled syringe to boost uptake.
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The company's financial guidance for 2025 is challenging due to uncertainties in product commercialization and market dynamics.
Q & A Highlights
Q: Could you remind us about the commercialization pathway going forward for FYB206? A: Stefan Glombitza, CEO, mentioned that they are in a competitive process with high interest in the asset. They plan to intensify out-licensing discussions and aim for tangible results next year. Nicola Mikulcik, Chief Business Officer, emphasized the importance of choosing the right partners and commercial models, noting strong interest from potential partners due to Formycon's track record.