Release Date: October 24, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Xbrane Biopharma AB (STU:7XB, Financial) reported a solid volume growth of 23% for Ximluci in Q3 compared to Q2, indicating strong market demand.
- The company has successfully scaled up production processes for its Cimzia and Opdivo biosimilar candidates, demonstrating competitive analytical similarity to reference products.
- Ximluci has achieved a market share of over 1% in a EUR1.2 billion market, ranking second among ranibizumab biosimilars in Europe.
- Xbrane Biopharma AB (STU:7XB) is making progress in out-licensing efforts for its biosimilar candidates, with ongoing negotiations and nonbinding proposals received.
- The company has implemented a cost-saving scheme, realizing SEK22 million in savings and reducing staff by 35, contributing to a decrease in overall expenses by 34% compared to Q4.
Negative Points
- Despite volume growth, Ximluci's net sales remained stable due to a negative mix effect, impacting revenue.
- The company received a Complete Response Letter from the FDA for Ximluci, requiring additional work to address deficiencies before resubmission.
- Xbrane Biopharma AB (STU:7XB) reported a lower net profit share for Ximluci in Q3, attributed to one-time marketing costs and a lower price/mix.
- The cash position decreased to SEK31 million by the end of the quarter, highlighting potential liquidity concerns.
- R&D expenses remain significant due to ongoing commitments for Ximluci, Xdivane, and XB003, potentially impacting future financial flexibility.
Q & A Highlights
Q: Are there big quarterly volatilities related to STADA's Ximluci-related costs, given that profit split in Q3 is lower than in Q2, despite the growth of 20% in volume?
A: Martin Amark, CEO: Historically, there hasn't been huge volatility, but this quarter included one-time marketing costs, which we don't expect to recur in the next quarter. However, such efforts might be necessary in the future.
Q: Can you provide any guidance on the Xdivane out-licensing deal currently being negotiated?
A: Martin Amark, CEO: We are seeking a commercialization partner for Xdivane, granting an exclusive license for certain regions. Discussions are ongoing with multiple parties, some on a global basis and others focused on major territories like Europe or the US.
Q: How certain are you about securing a deal with Xdivane, and what happens if you don't?
A: Martin Amark, CEO: We are optimistic given the current stage and timeline alignment with counterparties. We are also in discussions with shareholders and potential investors to find solutions if the timeline extends.
Q: How should we view the R&D cost base in the coming quarters, given ongoing activities?
A: Martin Amark, CEO: Significant commitments remain for Ximluci, Xdivane, and XB003. R&D spend will likely remain similar to recent quarters, with potential reductions expected from Q2 next year as current undertakings conclude.
Q: What's the reasonable upfront payment for Xdivane and XB003 if deals are completed? Can investors hope for a plus $10 million upfront for the products combined?
A: Martin Amark, CEO: A $10 million upfront is a reasonable expectation, based on previous deals like Ximluci to STADA and XB003 to Biogen, which had upfronts of EUR8 million and USD8 million, respectively.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
