Anybody else out there interested in these?

2002 Results are due in April, and they are expected to show a maiden profit.
Last week I opened a small speculative long (spreadbet), but I am looking to add to this position a lot more if we get any sort of resolution over Iraq crisis before the results which should spark a broad market rally from which SKP could really benefit and have a strong run-up.

DYOR etc.


Here is a recent research note from Merrill Lynch (they estimate 0.25p EPS for 2002):


Merrill Lynch FlashNote

7 February 2003

SkyePharma

Newsflow Set To Continue BUY

Reason for Report: Company Update

EPS (Dec): 2001A -1.19p; 2002E 0.25p; 2003E 2.13p
P/E (Dec): 2001A NM; 2002E 180.0x; 2003E 21.1x

Michael Ashton, CEO SkyePharma, gave an upbeat and informative presentation today.

Depomorphine appears on track for US submission in June 03. The two pivotal trials (hip and lower abdominal surgery) have been concluded. To date, the results appear encouraging. Management believe that safety (eg respiratory depression and nausea) is not an issue for the drug.The company is also conducting an additional trial in C section patients which is completing enrollment and should be included in the European submission for Depomorphine later this year. We expect the pivotal trial data for Depomorphine to be presented at the American Society of Clinical Anaesthesiologists in October 2003.

Paxil CR continues to grow (accounting for c.26% of total Paxil scrips in the US). 50% of these Paxil CR scrips are repeat and Paxil CR accounts for c.7% of the total SSRI antidepressant market in the US. Paxil CR is already filed for pre-menstrual dysphoria disorder (PMDD). However, GSK also plans to submit the intermittent treatment of PMDD later this year.

SKP also confirmed that Quintiles plans to present new data for Solaraze at the American Society of Dermatology in March. SKP believes that Solaraze is making in-roads into the actinic keratosis market and appears to be taking market share from Ephedrex (5-FU). Clinical trials in Australia are on track, with SKP planning to submit Solaraze to the Australian regulatory authorities in 2004 (second largest market opportunity after the US).

Enzon has already started to market DepoCyt in the US and SKP expects to see wider usage of the drug by key oncologists in the next few months. Phase IV studies for the neoplastic meningitis indication are on track, with an FDA Advisory Committee meeting (ODAC) scheduled next month.

Overall, we expect the newsflow for SKP to continue and reiterate our BUY recommendation with a price objective of 80p (based on applying the speciality pharma multiple to our 06E EPS of 14p and discounting back agressively at 30% p.a.). Risks to the stock include the general risk of drug development delay and product approval failure.

sunday press articles

International Markets:

Market over reacts to Paxil jitters

Shares in Skyepharma (LSE: SKP) plunged more than 13% Friday after GlaxoSmithkline (LSE: GSK) announced the FDA had seized batches of its Paxil CR drug manufactured at its facility in Puerto Rico. The issue appeared to arise from a small number of the controlled release formulation pills, reported to be as few as 8 per million pills manufactured, cracking such that the controlled release characteristics of the pills could not be guaranteed. The FDA and GSK had been aware of these issues for some months, yet GSK had failed to recall all the affected batches as had been requested by the FDA, and thus the FDA acted to seize batches to stop further distribution of the drug. GSK indicated that this could cause a shortage of the drug in the short term, although there were no safety issues with patients continuing to use supplies of the drug they already had. Analysts concluded that as no safety issues had been identified, the problem appearing to be a relatively easy to rectify manufacturing issue, that Paxil CR would be back on the market in the US soon. GSK and FDA confirmed they were working hard together to ensure that was the case. Even though the pharma industry is currently sensitive to perceived 'bad news' post Vioxx withdrawal and other recent issues, the reaction of Skyepharma's shareprice was seen as an over-reaction by analysts as the bulk of Skye's current value relates to higher value double digit royalty deals on drugs such as Depodur, a controlled release formulation of morphine, rather than the low single digit royalties it receives from GSK on sales of Paxil CR. It was also noted that Skye may be entitled to compensation from GSK for any loss of Paxil CR royalties it might otherwise receive.


from The Sunday Times

http://www.timesonline.co.uk/article/0,,2095-1512500,00.html


Puerto Rico plant causes Glaxo pain
A MANUFACTURING plant in Puerto Rico is the source of the problems that have given Glaxo Smith Kline a splitting headache, writes Paul Durman.
Shares in the drugs giant, which reached a 15-month high on Thursday, slid on Friday when the powerful US Food and Drugs Administration seized millions of tablets of Paxil CR, a top-selling anti-depressant, and Avandamet, a diabetes treatment.

The FDA is concerned that some Paxil tablets are splitting in half, with one part containing the active ingredient and the other the chemical that controls its release. It fears such poor-quality pills could pose risks to patients.

Glaxo said yesterday: We are pressing to see the FDA as quickly as possible. The company said only eight in 1m tablets were affected.

However, the FDA has had concerns about manufacturing at the plant for at least two years. It also produces the Avandia diabetes therapy and Coreg, a heart medicine for Glaxo. The firm said production of these was unaffected.

The seizure is also bad news for SkyePharma, which supplies the control-release technology used in Paxil CR.

At least some instituions are still buying:

Skyepharma PLC
08 March 2005


For Immediate Release 8 March 2005





SkyePharma PLC ('the Company')

Notification of Major Interest in Shares



In accordance with the Companies Act 1985 (as amended) the Company was informed
on 7th March 2005 that following a series of market making transactions on 4th
March 2005 by Dresdner Kleinwort Wasserstein Securities Limited ('DrKWSL'),
Allianz AG and its subsidiaries, which include DrKWSL, had increased their
notifiable interest to 40,577,590 Ordinary Shares, representing 6.5% of the
issued share capital of the Company. These Ordinary Shares are registered in the
name of DrKWS Nominees Limited.
.

WHy is this falling in the USA on daily basis?

Because they have promised and not delivered (also unfortunate FDA intervention in closing the GSK factory that manufactures Paxil, and the Astralis failure).

Thanks. They were supposed to be profitable by now. Are they?
Can it fall further?

They are certainly not profitable - the question is how much they have lost (apart from total loss of management credibility). Can they fall further? Name a price.

Hightech

recent guidance (recent for SKP anyway!) prior to xmas was that fy profit was dependent on certain deals, including the pulmonary product being signed and FDA approval of foradil. On the basis that these havent happened, and it looks like they are dragging results out fully on the 120 day rule on the hope of having some good news to announce to soften the blow, i am expecting a rather hefty loss again this year - somewhere in the region of 30-40m.

there is still a lot of potential good news in the pipeline, however, there is now the real danger of one or both of the pulmonary deal falling through completely and/or the need to raise further finances via a rights issue. i am resigned to a large loss when the results are released, more critical to me will be the cash position a long with long overdue updates on expected deals - if i am right due diligence on D3 had been going on for nearly 18 mths whereas what due diligence did SKP do when they bought Astralis shares from directors which have subsequently lost nearly 90% of their value in a very short space of time. also of interest will be what they are doing to recover lost revenues from glaxo re: their inability to manufacture it properly

the recent management of this company, and complete disrespect of shareholders, is starting to wear the patience of a lot of investors and there is likely to be fireworks at the AGM, with pressure being put on Ashton to resign. on a communication front they have gone from completely overpromising to refusing to update shareholders/the market except for at results time or when partners release statements that affect SKP.

also of interest is the current crest data which shows an almost all time high on the number of shares out on loan as well as a couple of market makers having notifiable holdings.

i expect that results day will see quite a large movement in share price and unless they finally deliver a couple of the outstanding deals and the cash position is still sufficent to provide the required working capital, i expect this movement is likely to be down. imho in the worst case scenario if there is a 40m loss, a rights issue and no deals signed the price could go as low as 30p

fwiw i still hold a much reduced level of holding, which amazingly are still in profit - however, if nothing has been announced by friday 15th april, i will be selling these and sitting on the sidelines until the results are announced at which stage i may rebuy.

Having said all that, i still have a lot of belief in the pipeline and the future potential for the company, however, i have completely lost faith in the current management. there is also the small chance that they may be taken out (not holding my breath)

all imho dyor etc etc

Fundamentalist
Good post I finely got shot of these last week after many years and a lot of averaging down at the end I was at a small lose, after reinvesting (ert) I am now in profit. I agree with what you say, a lot in the pipeline and the future potential for the company, and one day I'm sure this stock will be 300p but its the same old story again and again loss, loss wider, no profit, not yet, No Divi
I am on the sidelines now watching and waiting.

Its not looking to good at this momment 50 is it a gamble,,you bet it is.

DD

Annual results are out tomorrow and are not going to be pretty - be a very brave man buying in today

Agreed Fund but someone is brave - in fact, if you look at the trades it is more than likely that most of the "unknowns" are buys. A few buyers buying big, and a large number of sells generally selling smallish amounts.

Fundy they say the bad news is in the price,of late its been grim if your a holder but below 50 it mite be worth a long,no position as of yet.

I spoke too soon!

DD

i sold most a while back and have been looking to go back in - will see what tomorrow throws up before making my decision - key things im looking for:

D3 - updated guidance (ive given up hope theyll announce it)
cash position - is a rights issue on the horizon as they run out of cash?
Foradil update
Paxil/GSK update - when back to market/recompense/royalty rate negotiations
other pipeline announcements


dare say if there is no D3 and a rights issue then the removal of Ashton has to be next

Looks like anyone brave enough yesterday will be well rewarded!!!

LONDON, UK, April 28, 2005 - SkyePharma PLC (LSE: SKP; Nasdaq: SKYE) announces
the Company's preliminary results for the year-ended December 31, 2004.



Operating highlights

Agreement with GlaxoSmithKline for Paxil CR(TM) provides a $10 million
cash payment and a higher royalty rate and ensures royalty income received
even while Paxil CR(TM) remains off the market

Pulmonary package: Heads of Terms with major global pharma company for
Flutiform(TM) include up to $160 million in milestone payments and
reimbursement of development costs, with double digit royalties. Agreement
still subject to contract

Conditional UK marketing authorisation for DepoDur(TM)

DepoBupivacaine(TM) licensed to Mundipharma outside North America and
Japan

New agreements with Critical Therapeutics for zileuton and First
Horizon for fenofibrate

Two products expected to be launched in 2005, four products to be
filed for approval and four products to enter Phase III development



Financial highlights

Turnover up by 17% to 62.2m - excludes 5.5m of milestones received
during 2004 (2003: 53.2m)

Royalty income increased by 39% to 26.0m (2003: 18.7m)

Gross profit up 33% to 31.0m (2003: 23.4m)

Exceptional items of 3.0m (2003: 9.5m)

Operating loss before exceptionals and amortisation fell by 59% to
9.7m (2003: 23.4m)

Operating loss after exceptionals and amortisation fell by 48% to
20.7m (2003: 39.5m)

Net loss fell by 44% to 24.3m (2003: 43.2m)

Loss per share 3.9p (2003: 7.1p)

End 2004 net cash 15.3m (2003: 22.0m)



Ian Gowrie-Smith, Non-executive Chairman, said: 'A highly beneficial new
agreement with GlaxoSmithKline for Paxil CR(TM), significant advances for both
our marketed products and our pipeline and important progress on the
long-awaited pulmonary deal are the keynotes of our performance. We now have
five key products on the market generating royalty income for us, with two more
expected to be launched this year, and a well-stocked pipeline of products in
late-stage development. Recent progress on corporate agreements brings us
several powerful new partners. We face the future with confidence.'

I thought it would be priced in the recent blood bath on the sp,no position yet sub 50 for me.

I decided to hold over the results time but admit to being rather lucky - I certainly never forsaw the Paxil deal (and I even used to be involved in the legal issues surrounding international contract re-negotiation and consequential IP licensing agreements - GSK were certainly not bound to compensate SKP!). Still, its about time I was lucky.

Pach

i held some over results but had sold all my trading batch a while back - will try and get some more today

Pachandl well held you should be good at poker with that sort of decision making.

Cheers DD. Fund - presumably you are waiting for a pull-back before committing? Having said that the odds do not favour the sp going lower than 54p.