Mayne Pharma Group received a complete response letter (CRL) from the US FDA regarding the application for a generic version of NuvaRing. Management is confident the issues raised by the FDA will be addressed in a timely matter.
Before this, UBS had expected NuvaRing to launch in the second half of FY21. Now, based on the update, the broker has pushed the launch to the first half of FY22.
UBS notes the pivot from generics to branded sales remains a work in progress for the group and points out in the interim, Mayne Pharma needs to protect its base revenues for the generics division.
The broker maintains its Neutral rating with a target price of $0.37.
Sector: Pharmaceuticals, Biotechnology & Life Sciences.
Target price is $0.37.Current Price is $0.32. Difference: $0.05 – (brackets indicate current price is over target). If MYX meets the UBS target it will return approximately 14% (excluding dividends, fees and charges – negative figures indicate an expected loss).
