Shire Share Discussion Threads

[zho] 02/5/2014 18:17

Shire, which on Thursday reported a 40% rise in first quarter earnings, found itself the centre of a number of takeover tales. It was variously said to be a target for Botox maker Allergan - as a defence against an unwanted bid from Valeant Pharmaceuticals - or AstraZeneca itself. Shire added 17p to £34.67.

[arja] 01/5/2014 13:41

depends on what USA thinks of the figures from 2.30pm as I assume US leads on futures opening as for most other dual listed stocks . More to go I think !

[steeplejack] 01/5/2014 12:06

Excellent figures but stock has been very strong of late partly on back of AstraZeneca developments.These results could consolidate recent price gains.

[luckymouse] 01/5/2014 12:06

Nicely taken - 3K in an hr - off to pub!

[luckymouse] 01/5/2014 10:56

Traders - whats your target 3440?

[arja] 29/4/2014 14:44

really fell off the cliff but a good punt at this level I suppose !

[steeplejack] 29/4/2014 08:40

Thursday


First quarter 2014 results date notification - May 1, 2014

Dublin, Ireland - April 17, 2014 - Shire plc (LSE: SHP, NASDAQ: SHPG), will
announce first quarter 2014 earnings on Thursday May 1, 2013.

Results press release will be issued at: 12:00 BST / 07:00 EDT

Investor conference call time: 14:00 BST / 09:00 EDT

[zho] 25/2/2014 13:31

Telegraph/Questor comment from 14th February:

[steeplejack] 13/2/2014 13:08

jolly,jolly good

[toposwope] 10/2/2014 09:59

Market has shrugged of Friday's news thus far...

[steeplejack] 10/2/2014 08:10

Full year results this Thursday,13th Feb

[zho] 07/2/2014 16:35

But Shire has slipped 42p to £30.99 after overnight news that Vyvanse, its treatment for hyperactivity, failed in two late-stage trials for adult depression. The drug performed no better than placebos, and Shire said it would no longer continue the development programme for major depressive disorders.

But analysts were not surprised by the outcome. Savvas Neophytou at Panmure Gordon kept his buy recommendation. In a note entitled "Did anyone really think that possible?", he said:

Investors keen to own Shire should prime themselves for a good buying opportunity today. We view last night's pipeline failure of Vyvanse in the treatment of depression as a missed upgrading opportunity rather than anything more sinister. Indication roll-out is a sensible strategy for growing products, but the use of Vyvanse in the treatment of Major Depressive Disorder was very low probability in our view.

Given the expected share price weakness this morning, we believe investors will have a good opportunity to buy stock at an attractive new level not seen since the announced ViroPharma acquisition in November.

Brian White at Shore Capital said:

While this is clearly disappointing for the company, we had previously highlighted that MDD was a riskier endeavour (than the development of Vyvanse in binge eating disorder).

Despite this disappointment, we believe these remain exciting times for Shire with plenty of optionality remaining in the pipeline and several programmes set to change the growth outlook. We believe that the profile of Vyvanse should be enhanced following last year's positive Vyvanse binge eating data and subsequent FDA submission later this year. We have previously written extensively about binge eating disorder, highlighting its position as the most common adult eating disorder, affecting around 1%-3% of the US population and representing approximately 4m adults.

Elsewhere Shire's portfolio of treatments in rare diseases continues to grow, strengthened recently with the acquisition of ViroPharma and we have yet to factor into our forecasts any contribution from the nascent ophthalmology franchise but recognise the potential should recent (mixed) lifitegrast data prove sufficient following Shire's ongoing discussion with FDA. Finally we expect M&A to remain a feature in 2014 and beyond given the company's strong cash generation.

[m.t.glass] 07/2/2014 08:06

In that December analysis, Berenberg's Mr Campbell said:

"..the loss of this (lifitegrast for dry eye) leaves the company still heavily reliant on ....Vyvanse."


In today's overnight announcement, in one particular trialled area, Vyvanse hasn't measured up. But continues in other areas. How significant is the failure?

The news was released after hours in the US last night, so there's US market reaction to come yet.

[cambium] 14/1/2014 15:18

Guidance update positive.

[brain smiley] 09/12/2013 10:52

Shire edged up 2p to £27.09 despite mixed results overnight from a trial of its Lifitegrast treatment for dry eye disease, casting doubt on its future potential. The drug did reduce symptoms of the disease but missed a target that measured signs of the disease based on corneal staining. Analyst Brian White at Shore Capital remained positive, repeating his buy recommendation:


Shire will take its time to look at the totality of the data and will speak to regulatory authorities. On the positive side it is the first therapy for dry eye which has met both the "signs" and "symptoms" of dry eye but over two quite separate clinical trials suggesting some variability which will require greater scrutiny.

But Alistair Campbell at Berenberg said:


Clearly these data are a blow for Shire, which is arguably compounded as this was one of the first major additions by Flemming Ornskov in his role as chief executive. We did not include this product in our model, but for those who did, the chance of approval in our view in now very low. Lifitegrast, if successful, arguably had blockbuster potential and the loss of this leaves the company still heavily reliant on [attention deficit disorder treatment] Vyvanse.

[brain smiley] 06/12/2013 12:07

BE

Shire Misses target on the final stage trial.

BE

Or, rather, it missed on of the two targets.

BE

Making approval look decidedly uncertain.

BE

Though, as the price reflects, no one seems to care overly because this was always a long shot.

BE

SocGen incoming.

BE


lifitegrast has missed in phase III and in our view, investors should assume this drug is highly unlikely to attain an approval in this indication and is likely to be discontinued; side effects were also problematic. Lifitegrast was acquired as part of the acquisition of SARcode Bioscience for an initial consideration of $160m in March 2013.

BE


SG view We had not included lifitegrast in our forecasts as we viewed the mixed data
from the OPUS-1 trial as a red flag and had not viewed lifitegrast or any of Shire's current
ambitions in ophthalmology as a potential major value driver of the share price. However,
we think investor expectations were higher (i.e. above zero) for lifitegrast, so any phase III
disappointment, especially for a company whose shares have been one of the best
performers in the FTSE-100 year-to-date, may lead to short-term share price weakness
partly on the phase III miss but also as an opportunity for profit taking. Given both the
proximity between paying $160m and the timing of the drug's phase III failure less than a
year later and Shire's recent setback with Dermagraft – acquired as part of the ABH
acquisition – Shire's M&A track record may again attract some scrutiny.

BE

...... Which is a fair point.

BE

Given Shire's meant to be buying growth, it'd be reassuring if it were better at it.

BE

And here's Jefferies.

BE


Equivocal outcome raises risks to approval: Headline OPUS-2 Phase III results for
lifitegrast versus placebo in dry eye disease are mixed, in our view, meeting the prespecified
primary endpoint for patient-reported eye dryness "symptoms" (p less than 0.0001 by Eye Dryness
Score) but failing to achieve the second co-primary endpoint of disease "signs" (p=0.6186
by inferior corneal staining score). Importantly, lifitegrast is the first drug to significantly
improve dry eye symptoms in a Phase III trial, the endpoint widely perceived to be more
challenging and potentially differentiating the product. However, in the earlier OPUS-1
pivotal study lifitegrast met the co-primary endpoint of signs by corneal staining (p=0.0007)
but failed to benefit symptoms by the vision-related OSDI function score. We note Eye
Dryness Score was a secondary endpoint in OPUS-1 and did show benefit (p=0.0291). Given
the FDA's typical requirement for two supportive Phase III trials, we envisage a potentially
challenging pathway to approval for lifitegrast and the possible need for Shire to consider
a third study. Our current modest $400m peak US sales, 50% probability and c.30p/share
NPV already fairly reflect this, with lifitegrast contributing

BE


Significant market opportunity if label can differentiate: Dry eye is a large market
with over 25m US dry eye sufferers, of which up to 35% require medical treatment and are
currently underserved with the only FDA approved treatment for increasing tear production
Restasis tracking US sales over $800m, suggesting only c.10% penetration. Commercially
we believe it is important for lifitegrast to benefit both signs and symptoms of the disease
to differentiate against incumbent Restasis. This is likely to be particularly relevant if, despite
the technical challenges, a generic company is able to meet the recent FDA draft guidance
requiring only in vitro bioequivalence for a Restasis ANDA filing once the Orange Book listed
patent expires in May 2014E.

BE


2014 pipeline bonanza: Significant news flow 2014E could boost belief in Shire's longerterm
organic growth prospects, which together with EPS growth accelerating potentially



+15% can justify multiple expansion. We are most optimistic for expanded Vyvanse use

in depression (MDD; peak $750m), with Phase III data mid-2014E, whereas despite recent
positive binge eating (BED; peak $300m) results we have lingering regulatory concerns. We
view Premiplex (peak $650m) to be perhaps the most overlooked programme, which "best
case" could reduce complications for preterm infants triggering an accelerated regulatory
filing after data 1H15E.

PM

(AJ -- as journalists we take vows of poverty and chastity)

BE

(@fjp73: SHP 18ish in this year, falling to 13-14ish next on consensus figures. And you'd be disappointed with both the quantity and quality of the free lunches on offer these days.)

[steeplejack] 06/12/2013 08:02

Or maybe not given the price response!Superficially,the phase III trials look to be a success but not unequivocal success reading it through.



Shire Reports Top-Line Results on OPUS-2, a Phase 3 Study Investigating the Use
of Lifitegrast (5.0% Ophthalmic Solution) in Adults With Dry Eye Disease

December 6, 2013 -- Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty
biopharmaceutical company, today announced top-line results from OPUS-2, a
Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution.
OPUS-2 compared lifitegrast to placebo administered twice daily for 84 days (12
weeks) in dry eye patients with history of active artificial tear use within 30
days prior to screening. Lifitegrast met the prespecified co-primary endpoint
for the patient-reported symptom of eye dryness (change in Eye Dryness Score
from baseline to week 12) (p-value.............

[steeplejack] 06/12/2013 08:00

Looks like good results.

[cambium] 06/12/2013 07:45

Shire reports top-line results in OPUS-26 December 2013 | 07:25amStockMarketWire.com - Shire Reports Top-Line Results on OPUS-2, a Phase 3 Study Investigating the Use of Lifitegrast (5.0% Ophthalmic Solution) in Adults With Dry Eye DiseaseShire confirms top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution for the treatment of adults with dry-eye disease.OPUS-2 compared lifitegrast to placebo administered twice daily for 84 days (12 weeks) in dry eye patients with history of active artificial tear use within 30 days prior to screening. Lifitegrast met the prespecified co-primary endpoint for the patient-reported symptom of eye dryness (change in Eye Dryness Score from baseline to week 12) (p-value