Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Formycon AG (XTER:FYB, Financial) exceeded its 2024 guidance in several key areas, including sales and EBITDA.
- The company achieved multiple milestone approvals and launches, expanding its global presence to 20 countries.
- Formycon AG successfully uplisted to the prime standard and was included in the SDAX and TechDAX, enhancing its visibility in global capital markets.
- The company has a strong and growing pipeline, with significant progress in late-stage assets and new product introductions expected to drive future revenue.
- Formycon AG anticipates achieving EBITDA profitability as early as 2026, supported by strategic partnerships and market expansions.
Negative Points
- The US market presented headwinds, with Sandoz pausing sales of a key product, impacting revenue expectations.
- Formycon AG faced significant impairments on its assets FYB201 and FYB202, affecting net income negatively.
- The company anticipates continued investment in its biosimilar pipeline, which will keep EBITDA negative in 2025.
- Market dynamics in the US for biosimilars remain challenging, with pricing pressures and reimbursement issues affecting performance.
- The company's financial performance is heavily reliant on successful commercialization and market penetration of its pipeline products, which face regulatory and competitive uncertainties.
Q & A Highlights
Q: Can you provide an update on the situation with Sandoz regarding the US distribution of FYB201?
A: We are in constant interaction with Sandoz. The pause in commercialization is due to the reimbursement price going down, which affects rebates and customer retention. Sandoz has experience with this strategy and is working on a plan to make the product sustainable in the market again. However, specific details of the strategy are still under discussion and cannot be fully disclosed.
Q: Is there a possibility of expanding into new regions with commercialization partners like MS Pharma in 2025?
A: We are expanding into more than 20 countries, including regions in Latin America and MENA. There is a high unmet need in these areas, and we are working on entering these markets with competitive pricing and robust product supply.
Q: Can you explain the increase in allocated costs for early-stage assets like FYB208 in 2024 and what to expect in 2025?
A: The increase in costs is due to progress in clinical stages and production scale-up, which are main cost drivers. For 2025, costs will continue to be significant as we advance in development, but they are expected to be capitalized on the balance sheet.
Q: What is the impact of the deferred tax income from the capitalization of internally generated intangible assets?
A: This relates to adjustments in our models, particularly for FYB202. The deferred tax is adjusted based on these models, impacting our income tax expense line.
Q: How does Formycon choose partners for regional commercialization, and why not opt for a global partner?
A: The biosimilar markets are very local, with different companies excelling in different regions. We look for partners strong in oncology and hospital oncology, with local market understanding and distribution networks. This regional approach is more effective than a single global partner.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
