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(Sharecast News) - Hikma Pharmaceuticals upgraded full-year guidance for its generics arm and reported a rise in first-half profit and revenue as it hailed a strong performance in both the generics and branded segments, and resilience in the injectables business.
back on track. good.
Finally launched in US after delays in FDA approval. Should see a small bounce up in the sp but more importantly in the future profits of the company. Big market cap for asthma drugs.
Advair Rival Awaits FDA Action On ANDA Supplement
Providing the latest update on Hikma’s generic rival to Advair – which was approved late last year and was about to be introduced to the market, only for the launch to be halted by the need for an amendment to the abbreviated new drug application to reflect enhanced packaging controls (Also see "Hikma Suspends Roll-Out Of Advair Rival" - Generics Bulletin, 18 Jan, 2021.) – Olafsson commented that “we really just paused the launch of this product.”
“The review time of our generic Advair application was a long one, it was nearly five years,” Olafsson explained, with Hikma and development partner Vectura having received multiple complete response letters from the US Food and Drug Administration linked to the ANDA. “And during that time, there are obviously multiple updates that you need to do, science has moved on, and in this case our analytical method for the primary packaging material had moved on in [terms of the] science. So the FDA asked us to submit this as a pre-approval supplement.”
Asked whether this process was seen as a formality for the product, Olafsson said “we are very confident we have submitted all the data [and] the FDA granted us a priority review of the PAS. So it is a timing issue, I wouldn’t expect this to be a risk for the product in any way or form.”
Pressed on whether Hikma had specific expectations on when it would be able to resume launch activities for its generic, he said “it’s always difficult to guess on the timing from the FDA – you’re probably always wrong when you guess it – but I think second quarter, even though we are not guiding towards that, sometime in the second quarter wouldn’t be an unreasonable time to think about the launch.”
It’s today
Confused about the XD date. Most websites suggest this is today but the report suggests it is the 19th. Anyone know which is correct?
Confused. Report says XD on 19th but most websites quote 18th. Anyone know which is right?
Yes you do need to answer that question, you don't make any sense.
going ex div tomorrow - hoping for the share price to pick up later!
Goes EX dividends tomorrow - hoping share price will pick up later??
Well has,nt it
Do I really need to answer that question.
Why will going ex div affect the share price ?
Goes ex divi on19th so should rise next few days hopefully.
I bought these originally based on momentum but that seems to have well and truly fizzled out.
Sorry for the repeated messages - Couldnt see them for ages as the chat platform seems laggy and buggy :.( Nevertheless despite this inconvenience LSE is my favourite stock research platform!
I just listened to their investor webcast available on the Hikma website for the 2020 FY results.
I think its a great set of numbers. 12% down now - Im still glad I invested in them as the fundamentals seem pure. The only reason given that explains the drop today is that Advair launch is now delayed probably by an additional 4 months to June because the FDA came in with a last minute regulatory challenge (that seems low risk) related to their Packaging quality controls.
I was generally really pleased with their results apart from the drop in net income. With BIden in im really looking forward to seeing how their sales grow post Covid.
I listened to their investor webcast on their website and it seems the drop may be due to further delays to the Advair launch probably until June now. The FDA came in with additional regulatory delays around packaging but seemingly low risk.
I just listened to their investor webcast available from their website. Generally Im very glad with the results... although the drop in net income needs some navelgazing.
The biggest news I could find that may explain the drop is that the generic Advair launch is delayed probably until June due to some last minute (probably low risk) FDA regulatory challenges
M
The corporates want a part of the success give a few days and it will fly .I got in today on the drop its madness
How the hell has this gone down this morning?!
Fantastic results and the share down amazing time to top up with the big boys
Fairly detailed analysis of Hikma Pharmaceuticals: https://www.youtube.com/watch?v=8eFaOtB9fBY
All in a very good defensive stock! Good solid back record and revenues only going to benefit (in my opinion) from Corona situation and Biden presidency
LONDON MARKET MIDDAY: Vaccine Rally Showing No Signs Of Fatigue
Wed, 11th Nov 2020 12:35Alliance News
(Alliance News) - Stock prices in London continued to push higher at midday on Wednesday on optimism for a coronavirus vaccine, while equity markets in the US were pointed to fresh highs.