Q2 2024 Orexo AB Earnings Call Transcript
Key Points
- Zubsolv revenue growth rebounded strongly from Q1, showing positive alignment between sales to pharmacies and wholesalers.
- Positive EBITDA for the third consecutive quarter, indicating financial stability.
- Successful completion of a new human factor study for OX124, addressing one of the FDA's concerns.
- Orexo AB (ORXOY) is rated in the top 5% of companies assessed by EcoVadis for sustainability.
- Continued progress in the AmorphOX pipeline, with impressive stability data for large molecules.
- OX124 approval and launch timelines have been delayed due to additional data requests from the FDA.
- Decline in Abstral royalties expected as contracts in key markets expire.
- Increased legal expenses related to the DOJ investigation in the US.
- Continued low growth in the buprenorphine/naloxone market, impacting overall demand.
- Potential risk to Zubsolv revenue guidance due to wholesale inventory adjustments and Medicaid disenrollment.
Welcome to this half-year interim report for Orexo, a quarter and half year which has been a little of a mixed back with some good progress, but also some areas where we have been surprised by a negative -- recent negative development. So I think the headline of today is probably the complete response letter we received on OX124 on -- very late on Tuesday evening and also the press release we had yesterday.
I would just start to say that for Orexo that we would receive a complete response letter was not a surprise. We had expected that. We did talk about that in our last-quarter report that we would be delayed, and that was due to the human factor study and the instructions for use that needed to be updated.
However, there were some requests for technical data that came as a surprise, and that requires a little more work from our side. But I will come back to that.
But I think the really positive thing is that there's only one problem in the complete response letter with the product, and that was related to the
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