Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Formycon AG (XTER:FYB, Financial) reported strong operational performance in the first half of 2024, exceeding expectations in key financial indicators.
- The company expanded its global presence, launching and marketing in 19 countries with commercial partners.
- Significant regulatory milestones were achieved, including a positive CHMP opinion for the Stelara biosimilar in Europe, with expected approvals in early Q4 2024.
- The Eylea biosimilar received FDA approval on schedule, with EMA regulatory procedures progressing as planned.
- Formycon AG (XTER:FYB) has a robust pipeline with promising early-stage developments, including biosimilar candidates targeting high-growth markets.
Negative Points
- Revenues in H1 2024 were reduced compared to H1 2023, primarily due to the absence of a one-off payment from the previous year.
- Increased costs in SG&A and R&D were noted, impacting the EBITDA, which was reduced as anticipated.
- The company faces ongoing litigation challenges related to patent issues, which could affect the timing of product launches.
- There is uncertainty regarding the exact timing of the launch for the Stelara biosimilar in Europe due to confidentiality agreements.
- Market dynamics and competitive pressures, particularly in the US, could impact the commercialization strategy and market share for new biosimilars.
Q & A Highlights
Q: Can you explain the discrepancy between the impact of FYB201 on the top line and the equity accounting number?
A: The discrepancy arises because the numbers in Q1 2024 were based on estimates, leading to a higher range of EUR6.8 million. In Q2, the performance was roughly EUR8 million, including milestones from the MENA region. We expect a slight decline in market sales volume and price pressure in the second half, impacting the financial performance of our joint venture in Bioeq.
Q: What can we expect regarding success payments for FYB202 in the second half and in 2025?
A: We expect further milestones upon receiving approvals in the US and Europe this year. Approximately EUR48 million in revenues have been recognized so far, with EUR25 million cash payments received. For 2025, precise guidance is not available as it depends on partner planning and product performance ramp-up.
Q: Could you provide an update on the potential commercialization of FYB203 and the patent situation in the US and Europe?
A: We are in the final selection process for commercial partners and expect to finalize deals in the coming months. Regarding patents, we are involved in litigation procedures and expect more clarity soon. We aim for a launch in 2025, pending litigation outcomes.
Q: When will you disclose the reference drugs for FYB208, FYB209, and FYB210?
A: We plan to disclose the reference drugs for FYB208, FYB209, and FYB210 by the end of this year.
Q: What are your thoughts on the commercialization race for FYB202, considering the dynamics seen with Humira biosimilars?
A: The Humira biosimilar market is opening up, which is promising for our Stelara biosimilar. Our partner, Fresenius, has a strong network and experience with similar assets, which should aid in successful commercialization. We anticipate a competitive market but are confident in our partner's capabilities.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
