RE: No bounce back28 Apr 2018 21:07
Hi Aidan. IMO slides 18-20 from the recent results presentation make things rather clear. That is where you need to start to fully appreciate the implications of what is going on in the background.
The impending litigation issue is massive for GSK as the incumbent and if VEC lose they can say goodbye to becoming a major player. If VEC win there are only two things GSK can do.... either come to an agreement to share the spoils in return for VEC NOT bringing in generic competiton for the Ellipta range or remove VEC from the equation by buying them out!
A directly substitutable AB-rated generic drug device for the Ellipta series is massive. VEC are also working on generic versions of the three biggest respiratory sellers in the US space as well, even though VR315 (Advair) is delayed.
The barriers to entry for generic delivery technologies are getting higher, with recent FDA moves making that much clear and is reiterated in the presentation. On Advair, Hikma, Mylan and Sandoz have all run foul of the new definitions of bio-equivalence and delivery equivalence.
The only short term winner there is GSK. However, the info from those slides now being made public... puts GSK in a serious position. As VEC said... partnership discussions are already taking place... and given the huge stakes that could even be with the huge tier one Pharma companies!
If VEC succeed with the generic device then they will have generic versions of the Ellipta series and, likely, Advair to US market in 2020. Those 6 products make up a huge chunk of GSK respiratory revenues. The US sales alone for those 6 products is expected to be around $6Bn by 2023. Worldwide projections are mindboggling! The others might get generic Advair to market but VEC are the only ones who might get generic Ellipta to market in the next 7-10 years because they are the ONLY company that has the delivery device technology already in play!
VEC sp is (IMO) depressed due to market uncertainty on how all this is going to pan out. IMO GSK will try to wait till these issues are sorted in the high court with fingers crossed that no-one else make a bid in the meantime... there is no point in themselves making a bid for VEC until the case is heard... because they could win... and all the generic competition problems go away for them! IMO they will only enter the fray if someone else DOES make a bid... because (as the incumbent) it's their market lose and there is no way they can let a projected $6 billion a year escape from them! I think it unlikely that any of the usual suspects will bid because they also will want to wait on the litigation results and will realise GSK will fight tooth and nail to protect their potential future marketts... and ain't gonna sit back and let them win! This isn't for the 'faint hearted' If it all falls apart for VEC in court... best look for somewhere else to put ya dosh... in my opinion! GLA.