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Moberg Pharma: EU approval but pressure from delay and share issue - Redeye

Redeye was glad to see that Moberg Pharma received the EU approval within the indicated time frame. However, the decision to do a two-step launch will push meaningful sales into the future, making it necessary to seek new financing. The EU approval is a clear positive as the regulatory risk for the EU is a non-issue. The setback with the API manufacturer for Terbinafine is a negative surprise as it means a significant delay of larger volumes into 2026e and 2027e. The EU approval without changing circumstances surrounding the launch would have been a real catalyst for the share. The delay in expected sales and the dilution effect makes us cut our fair value range and Base case.

Redeye was glad to see that Moberg Pharma received the EU approval within the indicated time frame. However, the decision to do a two-step launch will push meaningful sales into the future, making it necessary to seek new financing. The EU approval is a clear positive as the regulatory risk for the EU is a non-issue. The setback with the API manufacturer for Terbinafine is a negative surprise as it means a significant delay of larger volumes into 2026e and 2027e. The EU approval without changing circumstances surrounding the launch would have been a real catalyst for the share. The delay in expected sales and the dilution effect makes us cut our fair value range and Base case.
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