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NASDAQ:SKYE LSE:SKP www.skyepharma.com UK tel: +44 (0)207 491 1777 US tel: +1 (212) 753 5780 Presentation to UBS Specialty Pharma conference Michael Ashton Chief Executive 24 May 2004
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2 Legal 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 SkyePharma’s business which could cause our actual results and developments to differ materially from those forward- looking statements are discussed in SkyePharma’s 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 19 th May 2004
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3 SkyePharma 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
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4 Drug 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
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5 Two business models Contract drug delivery project Example: Paxil CR Self-funded project Example: DepoDur RiskLow Medium NB much lower than for a NCE ReturnLowHigh Out-licence stageStart of projectLate-stage clinical trials R&D costs Partner (reimburses SkyePharma) $5-10 mn SkyePharma $25-50 mn Milestone payments Modest <$10 mn High $50-100 mn Royalty rate Low 3-7% High 20-50%
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6 A transforming business Integrated pharmaceutical developer Drug delivery service provider Developing own products for out- licence 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: Now: Paxil CR , Xatral ® OD/Uroxatral ®, Solaraze ®, DepoCyt ® Future: Foradil ® Certihaler ®, DepoDur , HFA-formoterol, Propofol IDD-D Strategic emphasis on royalty income over upfront milestone payments Royalty income to replace milestones as main revenue source, driven by
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7 London (HQ) Basel Lyon Montreal FDA/EMA approved manufacturing facilities San Diego Global infrastructure New York Malmö >400 staff worldwide of which 50% scientists / clinical staff Osaka Global business development coverage
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8 Key marketed products Paxil CR (GlaxoSmithKline) Xatral OD / Uroxatral (Sanofi-Synthélabo)
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9 Paxil CR – defending the Paxil ® franchise 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) Q1’04: $180 mn (+37%) SkyePharma royalty rate: low single digits It is very important to keep the sales effort behind Paxil CR John Coombe (GSK’s CFO) Feb 2004 Paxil CR has captured ~8% of the US SSRI antidepressant prescription market expect increase from start of US generic competition
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10 Xatral ® OD/Uroxatral ® Sanofi-Synthélabo AUR indication: approved Europe; Ph III US 2003 world sales €222 mn (+25% CER) Q1’04 world sales €72 mn (+50% CER) 2006 forecast: €500 mn (Sanofi-Synthélabo) SkyePharma royalty rate: mid-single digits 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
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11 Three key near-term pipeline products DepoDur (previously DepoMorphine ) Foradil Certihaler Propofol IDD-D
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12 DepoDur Endo, Medeus 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) US: approved by FDA 18 May ‘04 Europe:filed Nov ‘03 (UK, then mutual recognition procedure)
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13 DepoDur - 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: $250+m exploring scope for premium pricing
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14 DepoDur - potential endorsed Europe €100+m 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 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 SkyePharma’s share of sales 20-60% based on combined sales of DepoDur and Propofol IDD-D >50% share if combined sales >$250 mn
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15 Foradil Certihaler Novartis/Schering-Plough Schering-Plough to market in key US market, Novartis elsewhere Filed US & Europe Dec ‘02 (launches expected in H2 ‘04) 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) FDA “approvable” letter issued Oct ’03 European approvals 2004 (Switzerland, Austria, Finland….) SkyePharma return on sales: ~10% (royalty + manufacturing return) Active ingredient formoterol fast-onset, long-acting bronchodilator for asthma recent major study on maintenance use of formoterol raises value
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16 Propofol IDD-D Endo, SkyePharma North America: Endo (same terms as DepoDur ) Europe/Japan: licensees to be appointed est. sales potential for Propofol IDD-D : ~$200 mn improved version of AstraZeneca’s injectable anaesthetic Diprivan SkyePharma’s 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 Q2’04; target filing: 2005; target launch: 2006
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17 Well-stocked pipeline Fenofibrate Propofol IDD-D Busulfan Multiple SkyePharma Endo / SkyePharma SuperGen Baxter SOLUBILISATION Solaraze Multiple Status is most advanced project Quintiles/Shire Trigenesis TOPICAL DepoCyt DepoDur Psoraxine * DepoBupivacaine HGH Interferon alpha-2b Undisclosed Enzon/MundiPharma/Nippon S’yaku Endo / Medeus Astralis * SkyePharma SkyePharma GeneMedix Chugai INJECTABLE Foradil Certihaler Pulmicort HFA Formoterol HFA QAB 149 Formoterol Combi Novartis AstraZeneca SkyePharma Novartis SkyePharma Paxil CR Xatral OD Madopar DR Coruno Nifedipine Diclofenac Requip zileuton Undisclosed Statin NK-104 Undisclosed Altace GlaxoSmithKline Sanofi-Synthelabo Roche Therabel Mundipharma Ratiopharm GlaxoSmithKline Critical Therapeutics Merck KGaA Kowa Undisclosed King ORAL marketedapprovedfiledPh.IIIPh.IIPh.Ifeasibilityproductlicence or partner SkyePharmaClient products * SkyePharma has an option on world rights for Psoraxine TM, exercisable at the end of Phase II PULMONARY
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18 2003 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
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19 2004 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
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20 Newsflow 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
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21 Key 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
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22 Newsflow 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 Formoterol+fluticasone HFA-MDIPh II/III start Zileuton (Critical Therapeutics) Ph III start (COPD) Psoraxine (Astralis) Ph II start DepoBupivacaine Ph II start
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23 Investment highlights Strategic focus on royalties rather than upfront payments Strong near-term clinical pipeline 1 Filed, 4 x Phase III, 3 x Phase II Changing quality of earnings driven by royalties from Paxil CR , Xatral ® OD/Uroxatral ®, Solaraze , DepoCyt ® Ten FDA-approved products validate drug delivery technologies - with Foradil ® Certihaler ®, DepoDur , HFA-formoterol & Propofol IDD-D close behind Two major product launches expected in H2 ’04
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NASDAQ:SKYE LSE:SKP www.skyepharma.com Investor relations contacts: London Peter Laing, Director of Corporate Communications 44-(0)207-491-1777 plaing@skyepharma.co.uk New York Sandra Haughton, US Investor Relations Manager 1-212-753-5780 shaughton@skyepharma.com …and please visit our website
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