Title: NASDAQ:SKYE LSE:SKP
1Presentation to UBS Specialty Pharma conference
Michael Ashton Chief Executive 24 May 2004
NASDAQSKYE LSESKP www.skyepharma.com UK
tel 44 (0)207 491 1777 US tel 1 (212) 753 5780
2Legal statement
This presentation does not constitute or form
part of any offer for sale or subscription or
solicitation of any offer to buy or subscribe for
any securities in SkyePharma PLC nor shall it or
any part of it form the basis of or be relied on
in connection with any contract or commitment
whatsoever. This presentation is only being
distributed to persons who fall within Article 8
of the Financial Services Act 1986 (Investment
Advertisements) (Exemptions) (No 2) Order 1997 or
Article 11(3) of the Financial Services Act 1986
(Investment Advertisements) (Exemptions) Order
1996, as amended. This presentation includes
certain forward-looking statements with respect
to certain development projects, potential
collaborative partnerships, results of operations
and certain plans and objectives of SkyePharma
including, in particular, the statements
regarding potential sales revenues from Paxil CR,
targeted sales revenues from other products both
currently marketed and under development,
possible launch dates for new products, and our
revenue and profit guidance for the 2004
financial year. By their very nature
forward-looking statements involve risk and
uncertainty that could cause actual results and
developments to differ materially from those
expressed or implied. The significant risks
related to SkyePharmas business which could
cause our actual results and developments to
differ materially from those forward-looking
statements are discussed in SkyePharmas SEC
filings under the caption Risk
Factors. SkyePharma reports under UK GAAP.
Where US dollar equivalents have been provided
for convenience in this presentation, a fixed
exchange rate of 1.78 1 has been used
throughout. These dollar equivalent numbers do
not imply restatement from UK GAAP to US
GAAP. This presentation was updated on 19th May
2004
3SkyePharma in brief
- UK-domiciled speciality pharmaceutical company
- originally founded 1983, IPO 1996
- listed London (SKP), New York (ADR, SKYE)
- market capitalisation 395/705 mn
- (19 May 64p/share, 11.80/ADR)
- small equity stakes held by GlaxoSmithKline,
Novartis and Kowa
4Drug delivery making good drugs better
- We normally work on drugs already proven safe and
effective - low risk of clinical failure
- short development times
- low development cost
- contrast with biotech!
- We rely on partners for sales and marketing
5Two business models
6A transforming business
Nine Ten approved products FDA approvals validate
three of our five delivery technologies Foradil?
Certihaler? approvable letter (Oct 03)
validates fourth (pulmonary)
Strong clinical pipeline 1 Filed, 4 x Phase III,
3 x Phase II
Changing quality of earnings
Strategic emphasis on royalty income over upfront
milestone payments Royalty income to replace
milestones as main revenue source, driven by
Now Paxil CR?, Xatral OD/Uroxatral, Solaraze,
DepoCyt
Future Foradil Certihaler , DepoDur?,
HFA-formoterol, Propofol IDD-D?
7Global infrastructure
London (HQ)
Malmö
Basel
Montreal
Osaka
San Diego
Global business development coverage
FDA/EMA approved manufacturing facilities
gt400 staff worldwide of which 50 scientists /
clinical staff
8- Key marketed products
- Paxil CR? (GlaxoSmithKline)
- Xatral? OD / Uroxatral? (Sanofi-Synthélabo)
9Paxil CR? defending the Paxil franchise
Paxil CR? has captured 8 of the US SSRI
antidepressant prescription market
- first US generic competition for Paxil started
8 September 03 - a prescription for Paxil CR? cannot be
substituted with generic paroxetine - but some indirect price pressure
- GSK still actively promoting Paxil CR?
- despite May 04 Appeals Court decision, GSK
still aggressively defending last patent for
Paxil (expires end-2006) - Paxil CR? US sales
- 2003 650 mn
- 2004 800 mn (est likely peak)
- Q104 180 mn (37)
- SkyePharma royalty rate low single digits
It is very important to keep the sales effort
behind Paxil CR? John Coombe (GSKs CFO) Feb
2004
expect increase from start of US generic
competition
10 Xatral OD/Uroxatral Sanofi-Synthélabo
- Once-daily Geomatrix? formulation of alfusozin
- uroselective alpha-blocker
- indication urinary symptoms of BPH
- On market in Europe ROW since 2000
- replacing multidose versions
- USA Uroxatral?
- new product on US market
- launched to urologists Nov 03
- launched to primary care Mar 04
- two USPs
- uroselection (no postural hypotension)
- no ejaculatory side-effects
- AUR indication approved Europe Ph III US
- 2003 world sales 222 mn (25 CER)
- Q104 world sales 72 mn (50 CER)
- 2006 forecast 500 mn (Sanofi-Synthélabo)
- SkyePharma royalty rate mid-single digits
11- Three key near-term
- pipeline products
- DepoDur? (previously DepoMorphine?)
- Foradil? Certihaler?
- Propofol IDD-D?
12DepoDur? Endo, Medeus
US approved by FDA 18 May 04 Europe filed
Nov 03 (UK, then mutual recognition procedure)
- Clinical trials (1000 patients) highly
statistically significant - hip/knee surgery, lower abdominal surgery,
caesarean section - Sustained-release morphine for relief of pain
after surgery - given as a single epidural injection
before/during operation - morphine released evenly over 48 hours (period
of peak post-op. pain) - minimizes breakthrough pain
- with conventional PCA, patient must react to
pain - no need for catheters and infusion pumps (
savings for hospital) -
- Disadvantages of conventional morphine
- effective analgesic but short-acting
- repeat doses need a catheter and an infusion
pump - catheter problems main barrier to wider use of
epidural analgesia - epidural route desirable (delivers direct to
brain, needs less morphine than IV)
13DepoDur? - potential market
- knee replacements revisions
- hip replacements revisions
- major abdominal surgery
- cesarean sections
- thoracic
- vascular
- 12 million key target surgeries a year across
the US and major Europe - surgeries associated with an ageing population
are growing at 6-7 per annum - market research indicates potential for 25 -
40 patient share in major territories. Assumes
pricing equivalent to IV PCA or epidural infusion
(125 per surgical procedure) - sales potential 250m
- exploring scope for premium pricing
14DepoDur? - potential endorsed
- USA/Canada
- 120m milestone deal with Endo Pharmaceuticals
(Dec 02) - rights for DepoDur? and Propofol IDD-D?
- option on related pipeline products including
DepoBupivacaine - SkyePharma bears development, manufacture costs
- Endo bears marketing costs
- SkyePharmas share of sales 20-60
- based on combined sales of DepoDur? and Propofol
IDD-D? - gt50 share if combined sales gt250 mn
- Europe
- 100m milestone deal with Medeus Pharma (Mar
04) - rights for DepoDur? only throughout Europe
- SkyePharma bears development, manufacture costs
- Medeus bears marketing costs
- SkyePharma share of sales 35-50
- 50 share reached at sales well below 100 mn
- Rights for rest of world still available for
licence
15Foradil? Certihaler? Novartis/Schering-Plough
- Active ingredient formoterol
- fast-onset, long-acting bronchodilator for
asthma
- recent major study on maintenance use of
formoterol raises value
- SkyePharma developed both Certihaler? device
and formulation - formulation keeps powder dry, ensures accurate
consistent dose
- now also being used in second collaboration with
Novartis (QAB149)
Schering-Plough to market in key US market,
Novartis elsewhere Filed US Europe Dec 02
(launches expected in H2 04)
- FDA approvable letter issued Oct 03
- European approvals 2004 (Switzerland, Austria,
Finland.)
SkyePharma return on sales 10 (royalty
manufacturing return)
16Propofol IDD-D? Endo, SkyePharma
- improved version of AstraZenecas injectable
anaesthetic Diprivan - SkyePharmas formulation unique - cannot support
microbial growth - no need for a preservative
- 2 emulsion ( lower injection volume and less
lipid) - not a generic
- designed for continuous uninterrupted 24-hour
sedation - ICU sedation is fastest-growing segment of
Diprivan market
- Ph II completed (5 mn milestone payment from
Endo) - Ph III to start Q204 target filing 2005
target launch 2006
- North America Endo (same terms as DepoDur?)
- Europe/Japan licensees to be appointed
- est. sales potential for Propofol IDD-D? 200
mn
17Well-stocked pipeline
SkyePharma
Client products
marketed
approved
filed
Ph.III
Ph.II
Ph.I
feasibility
product
licence or partner
Paxil CRXatral OD Madopar DR Coruno Nifedipine
DiclofenacRequipzileuton UndisclosedStatin
NK-104 Undisclosed Altace
GlaxoSmithKline Sanofi-Synthelabo
Roche TherabelMundipharmaRatiopharm GlaxoSmithK
lineCritical Therapeutics Merck
KGaAKowa Undisclosed King
PULMONARY
Foradil CertihalerPulmicort HFA Formoterol
HFAQAB 149 Formoterol Combi
NovartisAstraZeneca SkyePharma
Novartis SkyePharma
Enzon/MundiPharma/Nippon SyakuEndo /
MedeusAstralis SkyePharma SkyePharmaGeneMedix
Chugai
DepoCytDepoDurPsoraxine DepoBupivacaineHGHIn
terferon alpha-2b Undisclosed
SkyePharma has an option on world rights for
PsoraxineTM, exercisable at the end of Phase II
TOPICAL
SolarazeMultipleStatus is most advanced project
Quintiles/ShireTrigenesis
SOLUBILISATION
Fenofibrate Propofol IDD-D BusulfanMultiple
SkyePharma Endo / SkyePharma SuperGen Baxter
182003 results summary
- 2003 loss primarily due to delays in completing
3 key new agreements - milestone payments 24m vs 48m in 2002
- royalty income nearly tripled
- since year-end, two key deals signed on
excellent terms - DepoDur? / Medeus
- undisclosed pipeline product / First Horizon
- dermatology package also outlicensed April 04
- commercial terms agreed for pulmonary package -
with partner of choice - subject to due diligence
- 20m convertible bond issue completed
192004
- performance will depend on timing and structure
of deals - deliberate strategic shift away from upfront
payments to longer-term milestone payments and
higher share of profits - short-term impact on revenues and cashflow
- expect further substantial increase in royalty
income - 2004-05 diminishing dependence on milestones
- further guidance to be issued once key deals
completed
20Newsflow 2003 most targets met
- Filings
- DepoMorphine? US ?
- DepoMorphine? Europe ?
- Paxil? CR Social Anxiety FDA approval 17 Oct
- Paxil? CR PMDD intermittent ?
- (Paxil? CR PMDD continuous FDA approval 2 Sep)
- Corporate commercial agreements
- European licensing of DepoMorphine
- European licensing of Propofol IDD-D
- European licensing of DepoCyte? ?
- Licensing of Pulmonary products
- Licensing of Dermatology products
- Licensing deal with King Altace? ?
- Micap floated on AIM ?
- Product approvals/launches
- Uroxatral? US ?
- DepoCyte? Europe
- Foradil? Certihaler? US approvable 22 Oct
- Clinical trial progression
- Requip? Ph III start ?
- Propofol IDD-D? Ph II end ?
- Propofol IDD-D? Ph III start
- Pulmicort? HFA-MDI Ph III start ?
- Psoraxine (Astralis) Ph I start ?
- Clinical data publications
- DepoMorphine? Ph III
- Foradil? DPI Ph III
- Uroxatral? Ph III
21Key deals outstanding
- European rights for DepoDur? ?
- licensed to Medeus Pharma Mar 04
- 100 mn of milestones and 35-50 share of sales
- deal terms illustrate strategic drive away from
upfronts to higher share of profits - dermatology package ?
- licensed to Trigenesis Apr 04
- non-core products, pipeline and topical delivery
technologies - 20 mn in milestones and 10 royalty (35 of
sublicence income) - undisclosed cardiovascular pipeline product ?
- licensed to First Horizon May 04
- 50 mn in milestones 25 net royalty
- pulmonary package
- formoterol MDI, formoterol/fluticasone MDI,
budesonide MDI (US rights) - significant external/internal developments led
to rejection of substantial offer late 03 - commercial terms agreed with partner of choice
April 04 (subject to due diligence) - alternative partners also at due diligence stage
22Newsflow 2004 further progress
- Filings
- Requip? OD Europe (US 2005)
- Licence agreements
- DepoMorphine? (Europe) ?
- Pulmonary product package
- Unnamed pipeline product ?
- Dermatology assets ?
- Propofol IDD-D? (Europe)
- DepoBupivacaine? (Europe)
- Clinical data publications (by partners)
- DepoMorphine? Ph III ?
- American Pain Society, Vancouver 6-9 May
- Foradil? Certihaler? Ph III
- Uroxatral? Ph III
-
- Product approvals/launches
- Paxil? CR PMDD intermittent US ?
- DepoDur? US FDA approved 18 May
? - DepoDur? UK
- Launch of DepoCyte? Europe ?
- Foradil? Certihaler? US FDA
approvable Oct 03 - Foradil? Certihaler? Europe ?
- Clinical trial progression
- Propofol IDD-D? Ph III start
- Formoterol HFA-MDI Ph III start
- Formoterolfluticasone HFA-MDI Ph II/III start
- Zileuton (Critical Therapeutics) Ph III start
(COPD) - Psoraxine? (Astralis) Ph II start ?
- DepoBupivacaine? Ph II start
23Investment highlights
- Strategic focus on royalties rather than upfront
payments
Ten FDA-approved products validate drug delivery
technologies
Strong near-term clinical pipeline 1 Filed, 4 x
Phase III, 3 x Phase II
Two major product launches expected in H2 04
24Investor relations contacts London Peter Laing,
Director of Corporate Communications 44-(0)207-491
-1777 plaing_at_skyepharma.co.uk New York Sandra
Haughton, US Investor Relations
Manager 1-212-753-5780 shaughton_at_skyepharma.com
and please visit our website
NASDAQSKYE LSESKP www.skyepharma.com