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SkyePharma to report maiden profit in April ? (SKP)     

Slacker - 18 Feb 2003 09:52

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.


Homer - 07 Mar 2003 08:31 - 7 of 202

no one has discussions here. not enough ppl. its not really worth it mate. Im going back to ADVFN with my contribution to skp. DOH!!

Slacker - 07 Mar 2003 08:50 - 8 of 202

Homer
someone has to try and get the ball rolling

anyway here is the full blurb from csfb

CSFB 6th March 2003

Upgrading to Outperform vs Neutral. TP up to 105p (71p)

Our rating upgrade reflects our view of SKP's attractive portfolio of products, promising late-stage pipeline and probable move into reported profitability (even if it is flattered by financial structure). Our new share-price target is 105p (previously 71p).

Three big pharma companies relying on SKP's technologies.

Paxil CR is SkyePharma's most conspicuous success, in our opinion, accounting for 32% of new Paxil scripts in the US, with a 3% gross royalty from GlaxoSmithKline to SKP. (Note our model assumes the entry of generic paroxetine in fourth-quarter 2003). Similarly, Sanofi-Synthabo markets Xatral XL for prostatism in Europe and plans to launch it as UroXatral in the US in 2003. Schering-Plough plans to launch its Foradil Certihaler for asthma in the US in second-half 2003.

Excellent profit share on DepoMorphine and Propofol-IDD.

SEC documents reveal that SKP's deal with Endo on these exciting pipeline drugs provides exceptional economics, in our view. The US$37m in upfront fees from Endo, and from Enzon for DepoCyt, should enable the company to report a profit for 2002, because UK accounting rules are less prescriptive than US GAAP.

Positives outweigh negatives.

We believe the positives on SKP now significantly outweigh the negatives that we have previously emphasised, such as poor disclosure (DepoCyt withdrawal), circular deals (Bioglan and Astralis) and atypical financings (Paul Capital).

High growth rates.

We expect royalty revenue to grow from 7.3m in 2002 to 93.0m in 2006 (CAGR 89%). We forecast total revenue (including deal-related milestones) to grow from 71.1m in 2002 to 168.5 in 2006 (CAGR 24%). We forecast PBT to grow from 1.3m in 2002 to 61.1m in 2006. We expect basic EPS to grow from 0.2p in 2002 to 8.8p in 2006, although the number of shares outstanding could be increased by pre-agreed contingent share issues

Sharpsuit - 14 Mar 2003 09:48 - 9 of 202

Analyst at WestLB Panmure argues that the turn of events could be good news for GSK’s partner Skyepharma (SKP), which developed Paxil CR.
Malik forecasts Glaxo will want to make Paxil CR 50% of its anti-depressant franchise ahead of generic competition.



Analysts shrug off GSK's Paxil patent woes



A more effective version of Paxil likely to more than offset competition from generics

GlaxoSmithKline (GSK) has lost a landmark court case in its bid to defend Paxil from generic competition but analysts believe Paxil CR, the controlled release version of the anti-depressant will save the day.

The drug giant announced this morning that in a Chicago court battle Judge Posner ruled the hemihydrate patent for the blockbuster selling anti-depressant was valid but generic competitor Apotex’s anhydrate formulation did not infringe the patent.

The news knocked the stuffing out of the drug giants’ shares, and by late afternoon stood 3.1% to 1087p. Paxil counts as 10% of sales.

However Glaxo plans to appeal the ruling, which will take 12 months to be heard, and analysts say Apotex is unlikely to launch their generic version in the interim and according to James Culverwell at Merrill Lynch not until 20th September 2003 at the earliest.

Although the ruling casts a shadow over the stock analysts remain buyers. Navid Malik, analyst at Williams de Brosays on the bright side GSK had ‘partially favourable’ rulings on Paxil patents last year and he expects the company to start aggressively switching into Paxil CR, the controlled release version of the drug, which already counts for a third of new prescriptions. Paxil CR is considered to induce fewer side effects such as nausea and as such has a lower dropout rate. Malik forecasts Glaxo will want to make Paxil CR 50% of its anti-depressant franchise ahead of generic competition.

Culverwell has similarly adjusted his forecasts, anticipating a generic launch by 2004. He argues that the likely loss of Paxil is already in the price and the premature loss of the drug actually ‘removes the 2007 final patent expiry overhang’. However risks of litigation, R&D failure and adverse currency issues remain a concern.

On the plus side Dr. Keith Redpath, analyst at WestLB Panmure argues that the turn of events could be good news for GSK’s partner Skyepharma (SKP), which developed Paxil CR. Skyepharma shares fell 3% but Redpath argues that some City investors do not understand that doctors prescribing Paxil CR are unlikely to switch into a generic copy of Paxil original because of the side effect profile.

Glaxo said its earnings guidance remains at the high single digits for the present but warned it may be revised if a generic version is launched. Meanwhile a further case concerning Paxil is to be heard in Philadelphia.


Hectorp - 14 Mar 2003 18:13 - 10 of 202

Keep up the good work, I've come in to this website, so I'll also post on SKP.
Today's West LB Panmuir comments are obvious in advance to nearly everyone, so it came as no surprise.
Volume up today, as with many stocks

H.

chadd - 18 Mar 2003 23:14 - 11 of 202

Homer,to each his own.

I'm a long term holder in an identical position to Nathan above, ie after top slicing at the peak my residual holding is at very low unit cost.

I prefer this style of thread to the ADVFN SKP threads. Lets just communicate when there is something worthwhile to say, rather than on the other side where SKP is just a vehicle for for a lot of windbagging by the same few pompous prats on a daily basis. The whole thing degenerated into personal abuse of farsical magnitude over there.

For me, the few posts above tell pretty much the whole story as it stands at present. So although I regard myself as pretty well informed about this share, I've nothing to add. Sitting tight, keeping the faith, may top up soon.

regards to all fellow holders.

Slacker - 19 Mar 2003 11:50 - 12 of 202

I have added to my long position this morning and looking forward to results on the 2nd April.
Good luck to all holders

Slacker - 20 Mar 2003 16:41 - 13 of 202

If anyone wants an excellent introduction to this company and their products you can listen to a webcast of yesterday presentation at SG Cowans Annual Healthcare Conference found at this link


http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=SKYE&script=1010&item_id=719277

Slacker - 28 Mar 2003 12:25 - 14 of 202

FTSE 250 risers

SkyePharma 45-3/4 up 3

Merrill Lynch 'buy' with 80 pence price target
..............................................



results next wednesday

Homer - 28 Mar 2003 14:58 - 15 of 202

doh! im gonna buy some now

Slacker - 28 Mar 2003 17:40 - 16 of 202

Not too late to jump on board Homer,
looks like some others are just cottoning-on:


28 Mar 2003 13:50 GMT

SkyePharma rises on hopes of maiden profit

LONDON, March 28 (Reuters) - Shares in Britain's SkyePharma Plc rallied on Friday as analysts raised hopes the drug delivery specialist would report its first full-year profit next Wednesday and stay in the black thereafter.
The shares had climbed 7.6 percent to 46 pence by 1345 GMT, valuing the business at around 279 million pounds ($435.8 million).

Joint house broker Merrill Lynch said in a note to clients it expected SkyePharma to make a profit of 200,000 pounds for 2002, compared with a loss of 9.5 million in 2001.

The investment bank is also forecasting net profit of 15 million pounds for 2003, driven by milestone payments as SkyePharma clinches a European partner for its biggest new drug hope, painkiller Depomorphine.

SkyePharma, which made a four million-pound loss at the half-year stage, said in January it did not know for sure whether it would post a profit for 2002 as it signed two other drug partnering deals.

As both deals were signed at the end of December, the firm hopes to recognise some of the revenue from them in 2002.

"People have been looking for this for a while (a move to sustainable profitability), and this time I think we're going to see it," said Keith Redpath, an analyst at WestLB Panmure. He is forecasting 2002 pre-tax profit of about one million pounds.


Homer - 31 Mar 2003 08:32 - 17 of 202

not long to go now

leo1 - 31 Mar 2003 11:12 - 18 of 202

Good write up in yesterdays The Business

Homer - 03 Apr 2003 14:14 - 19 of 202

maiden profit of 1.33 mln. nice one skp, congrat to the managment

Fundamentalist - 26 Nov 2003 13:31 - 20 of 202

Do any of the previous holders of this share still do so? I have been holding for the long term (for a while now) and still feel this share has further to run. However, the share price has had a great run of late since its disappointing summer announcements. The only recent positive news I can find relates to its filing for a patent on Depomorphine, which doesn't seem to justify its latest rise. Does anyone know any more ?

Fundamentalist - 03 Dec 2003 18:08 - 21 of 202

Another contract tie up, this time with Novartis for one of their asthma drugs, on the back of the depomorphine announcement, has perked the shares up again. Any other holders/opinions out there?

rayrac - 04 Dec 2003 21:13 - 22 of 202

We have one big problem with SKP, a past director, Dr Gonnella, a major shareholder is selling on any rise. So far he has sold millions of shares, trouble is, he has still got 40 million more ready no doubt for the next good piece of news.

Skp have some major products on the market and many more due, but as long as Gonnella is there we have to be patient!

Fundamentalist - 05 Dec 2003 15:14 - 23 of 202

Recent RNS, Fidelity have increased their holding again, they now hold 11.93%. They also hold 5,000,000 6% convertible bonds due 2005.

Fundamentalist - 19 Dec 2003 19:29 - 24 of 202

Ian Gowrie Smith is standing down as chief exec to become a non exec director. Wonder what impact this is going to have - hopefully a positive one as he has never been well liked by the city and been deemed to be holding the share price back! Maybe he is making way before the takeover approach (wishful thinking on my part i believe). Still with the right man at the helm, things could certainly be looking up at SKP (all imho). Share price in US appears not to have reacted to the news!


LONDON (AFX) - Skyepharma PLC said Ian Gowrie-Smith will step down from his executive role as a chairman to a non-executive role at the company's next annual general meeting in 2004.
This will enable Gowrie-Smith to concentrate on his other business interests, including Triple Plate Junction PLC whose fund-raising and intention to join the Alternative Investment market are being announced today. He is a non-executive chairman of the gold exploration and mining company.
Gowrie-Smith said: "It has been a great challenge to start and then build first Medeva and now SkyePharma. However it is in the earlier stages of a company's development where I believe I can make the greatest contribution."


also, more news re Paxil CR today:



LONDON (AFX) - SkyePharma PLC said a new study has shown that patients with depression who were prescribed GlaxoSmithKline's controlled-release antidepressant, Paxil CR, were less likely to discontinue therapy than patients receiving immediate-release selective serotonin reuptake inhibitors (SSRIs).
Paxil CR is a modified version of Glaxo's SSRI antidepressant and incorporates SkyePharma's Geomatrix oral controlled release delivery technology.

Paxil CR has been available in the US market since April 2002 and SkyePharma receives a royalty on Glaxo's sales.
In the three months to Sept 30 2003, sales of Paxil CR were 110 mln stg, representing 30 pct of the US Paxil franchise.

Fundamentalist - 05 Jan 2004 14:32 - 25 of 202

Yet again Skyepharma have disappointed the city. Again, key deals have failed to be signed and the share price has plummeted 13.5p on the back of the RNS. The year end figures are going to be below expectations due to not signing the contracts in time, though they still expect the contracts to be signed in the near future.

Fundamentalist - 05 Jan 2004 14:43 - 26 of 202

Full RNS:


RNS Number:8370T
Skyepharma PLC
05 January 2004


For Immediate Release 5 January, 2004


SKYEPHARMA PROVIDES END-2003 TRADING UPDATE


LONDON, UK, 5 January 2004-- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announces a
Trading Update for the year ending 31 December 2003.


As a result of delays in concluding a number of key deals in 2003, revenues for
the year will be substantially below the #85-100 million range indicated at the
time of the Interim Results in September and below the #70 million achieved in
2002. Milestone payments remain a major source of our revenues, and this
shortfall primarily arises because several key deals that we had expected to
conclude in 2003 are still in negotiation, with finalisation now expected in
early 2004. With revenues below our budgeted revenue target, coupled with
greater than expected research and development costs (arising from delays to
completion of agreements involving the transfer of costs to the partner), the
Company now expects to report a loss for the second half of 2003 albeit less
than the loss we reported for the first half. A number of key deals, potentially
involving total milestone payments of up to $200 million and double digit
royalty income, remain in advanced stage negotiation with multiple potential
partners. We remain confident that these agreements can be concluded on
satisfactory or better terms in the current year. This would have a
correspondingly positive impact on the profit already budgeted for 2004 (which
assumed these agreements were signed in 2003).


The company expects to have cash balances of approximately #20 million at 31
December 2003, marginally lower than as at 30 June 2003, with debt levels
marginally higher than as at 30 June 2003. However cash should increase
substantially in 2004 as the above deals are concluded.


During the second half of 2003, the company signed several new product
collaboration deals. Announced today is a further technology licence deal in the
pulmonary area that was signed with GlaxoSmithKline at the end of 2003. However,
discussions to finalise the major deals that we had expected to be concluded by
31 December remain ongoing. A signed term sheet is in place for one transaction,
which we would anticipate closing within the next few weeks. In addition one of
our pipeline products, due to be filed for approval with the FDA in March, is
currently under advanced review by several potential licensees. Our largest
licensing opportunity is a package of products in the pulmonary field, for which
we are also in advanced discussions with a number of parties. A major clinical
study published in November suggests a substantial increase in the potential
commercial value of the bronchodilator formoterol, both alone and in combination
with an inhaled steroid. Our own combination with the steroid fluticasone is
making very satisfactory progress in clinical development, with a Phase I trial
now completed. We believe that these factors have significantly raised the value
of our inhaled product range and support our stance that the Company should
refrain from entering any collaboration that undervalues this part of our
product pipeline. The Company is so convinced of the potential value of this
particular product opportunity that we have already rejected terms including
milestones of up to $90 million and double digit royalty returns. We remain
confident that we will be able to finalise a deal with an appropriate partner in
the first quarter of 2004.


While every effort was made to bring these deals to completion on appropriate
terms by the 2003 year-end, the Company strongly believes that it is in
shareholders' best interests to conclude the best deal possible for these
critical products. Unfortunately the time required for due diligence and the
final stages of negotiations does not always accommodate the constraints imposed
by a year-end date. Indeed, this restriction has proved a significant impediment
to obtaining the deal terms we feel that our products warrant. We remain
confident that this is only a delay and expect to conclude these agreements in
early 2004.


OUTLOOK FOR 2004

Turning to the current year, we see the outlook as very positive for the
Company. Revenues and cash will be improved by the finalisation of the deals
referred to above that are currently under discussion, augmented by anticipated
milestone payments from deals agreed in prior years. As important, we expect a
further significant increase in our royalty income, which is becoming an
increasingly dominant factor in our revenues and, importantly, also in our
profits. We had already budgeted a profit for 2004 (assuming the agreements
still in negotiation were signed in 2003) and deferral of those agreements to
the current year would therefore have a correspondingly positive impact.


With the completion of the development phase of our growth, we are further
reorganising our R&D operations and some other business functions in order to
align the development base with our projected future R&D activities. Regrettably
this will mean some redundancies but we expect to emerge from this
reorganisation in a leaner and fitter form. This will involve a one-off cash
cost of approximately #3.5 million and some associated non-cash asset
write-offs. These will be taken as exceptional charges in both 2003 and 2004 as
appropriate. Thereafter shareholders should expect to see growth in operating
profits more closely aligned with the future growth in royalty income that we
expect, generated by products such as DepoMorphineTM.


Commenting on the Trading Update, Chief Executive Michael Ashton said: "We are
disappointed that we have not been able to meet the ambitious target we set
ourselves in April of revenue growth in excess of 40%. On the positive side,
royalty income should more than triple for the full year after increasing
fourfold in 2002, fulfilling our expectations. With our main royalty-earning
products Paxil(R) CR and Xatral(R) OD/UroXatral(R) likely to be joined in
2004 by Foradil(R) CertiHaler and DepoMorphineTM, we expect this gratifying
trend to continue in the current year. We cannot stress sufficiently that rising
income from royalties is the key to future sustainable profit growth for
SkyePharma. At our present stage of development, revenues and profitability are
still largely dependent on the level and timing of milestone payments, which by
their nature are very difficult to predict. While we are striving to become
consistently profitable, it would clearly not be in shareholders' best interests
to enter into new agreements with milestone payments that would produce current
profitability if those upfront payments did not reflect the value of our
investment or came at the expense of future royalty streams.


"With our increasing royalty share, the deals currently under negotiation and an
improved cost base, I am excited by the prospects for 2004.


"I can also report that the Company has been in discussion with our partner
GlaxoSmithKline over the royalty rate we receive on sales of Paxil(R)? CR. Legal
advice received by SkyePharma leads us to believe that we are entitled to a
substantial increase in the royalty rate from the date of entry of generic
paroxetine in the US market. If we are unable to reach agreement on this issue,
there is an arbitration procedure in place."


ends


A conference call on this Trading Update will be held today. Michael Ashton,
SkyePharma's Chief Executive Officer, will host the conference call. Investors
and other interested parties may access the conference call at 4:00 p.m. (GMT) /
11:00 a.m. (EST) by dialling +1 (612) 288 0337 for International callers and
(800) 230 1085 for US callers.


A replay will be available shortly after the conclusion of the conference call
by dialling +1 (320) 365 3844 for International callers and (800) 475 6701 in
the US and entering Access Code 716063.


The Company intends to publish its full-year results for 2003 at the end of
March.


SkyePharma PLC develops pharmaceutical products benefiting from world-leading
drug delivery technologies that provide easier-to-use and more effective drug
formulations. There are now nine approved products incorporating three of
SkyePharma's five technologies in the areas of oral, injectable, inhaled and
topical delivery, supported by advanced solubilisation capabilities. For more
information, visit www.skyepharma.com.


Except for the historical information herein, the matters discussed in this news
release include forward-looking statements that may involve a number of risks
and uncertainties. Actual results may vary significantly based upon a number of
factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. These include without limitation risks in obtaining and
maintaining regulatory approval for existing, new or expanded indications for
its products, other regulatory risks, risks relating to SkyePharma's ability to
manufacture pharmaceutical products on a large scale, risks that customer
inventory will be greater than previously thought, risks concerning SkyePharma's
ability to manage growth, market a pharmaceutical product on a large scale and
integrate and manage an internal sales and marketing organization and maintain
or expand sales and market share for its products, risks relating to the ability
to ensure regulatory compliance, risks related to the research, development and
regulatory approval of new pharmaceutical products, risks related to research
and development costs and capabilities, market acceptance of and continuing
demand for SkyePharma's products and the impact of increased competition, risks
associated with anticipated top and bottom line growth and the possibility that
upside potential will not be achieved, competitive products and pricing, and
risks associated with the ownership and use of intellectual property rights.
There can be no certainty that agreement in respect of the additional royalty
for Paxil(R)? CR claimed by the company will be reached with GlaxoSmithKline, or
that SkyePharma will succeed in the arbitration process or that an increased
royalty will be paid. SkyePharma undertakes no obligation to revise or update
any such forward-looking statement to reflect events or circumstances after the
date of this release.


For further information please contact:
SkyePharma PLC +44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications +44 207 491 5124

Sandra Haughton, US Investor Relations +1 212 753 5780

Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court
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