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Michael Ashton Chief Executive Banc of America Securities Specialty Pharmaceuticals Conference 29 July 2004 NASDAQ:SKYE LSE:SKP www.skyepharma.com UK tel: +44 (0)207 491 1777 US tel: +1 (212) 753 5780 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 forwardlooking 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 $1.85 = £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 July 2004 2 What is drug delivery? Not “truck” delivery! 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 4 Pharma pipelines are drying up M a jo r n e w c h e m ic a l e n tity a n d b io lo g ic s u b m is s io n s to F D A 80 70 60 50 40 30 20 10 0 1993 S ourc e: F DA 1994 1995 1996 1997 NCE s 1998 1999 2000 2001 2002 2003 O riginal biologic s 5 Drug delivery deals still getting done… Number of Drug Delivery Deals 1993-2003 140 120 Delas in year 100 80 60 40 20 0 1993 Source: Windhover 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 6 …but deal values lower than biotech Value of Drug Delivery vs Biotech deals Average deal value $ mn 90 80 70 60 50 40 30 20 10 0 Drug delivery - all Drug delivery Biotech - all phases clinicals phases NB excludes deals for products that have been approved Source: Windhover Biotech - clinicals 7 SkyePharma in brief UK-domiciled speciality pharmaceutical company originally founded 1983, IPO 1996 listed London (SKP), New York (ADR, SKYE) market capitalisation £380/$710 mn (19 Jul: 61p/share, $11.43/ADR) small equity stakes held by GlaxoSmithKline, Novartis and Kowa 8 Two business models Contract drug delivery project Self-funded project Example: Paxil CR Example: DepoDur Medium Risk Low Return Low High Out-licence stage Start of project Late-stage clinical trials Partner (reimburses SkyePharma) SkyePharma $5-10 mn Modest $25-50 mn High <$10 mn Low $50-100 mn High 3-7% 20-50% R&D costs Milestone payments Royalty rate NB much lower than for a NCE 9 A transforming business Drug delivery service provider Developing own products for outlicence Integrated pharmaceutical developer 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 10 Global infrastructure London (HQ) Basel Lyon Montreal San Diego FDA/EMA approved manufacturing facilities Osaka New York >400 staff worldwide of which 50% scientists / clinical staff Global business development coverage 11 Key marketed products Paxil CR (GlaxoSmithKline) Xatral OD / Uroxatral (Sanofi-Synthélabo) 12 Paxil 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 It is very important to keep the sales effort behind Paxil CR John Coombe (GSK’s CFO) Feb 2004 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 expect increase from start of US generic competition 13 Xatral OD/Uroxatral 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 ® Sanofi-Synthélabo Xatral/UroXatral sale s tre nd 1996-2003 250 US launch Nov '03 200 EU launch Apr '00 Sales € mn ® 150 100 50 0 1996 1997 1998 1999 H1 RoW H1 US 2000 2001 2002 2003 FY RoW FY US AUR indication: approved Europe; Ph III US 2003 world sales €222 / $250 mn (+25% CER) Q1’04 world sales €72 / $90 mn (+50% CER) 2006 forecast: €500 mn (Sanofi-Synthélabo) SkyePharma royalty rate: mid-single digits 14 Three key near-term pipeline products DepoDur (previously DepoMorphine) Foradil Certihaler Propofol IDD-D 15 DepoDur US: Europe: Endo, Medeus approved by FDA 18 May ‘04 filed Nov ‘03 (EU mutual recognition, UK as reference country) 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 CSF, needs less morphine than IV) 16 DepoDur - potential market knee replacements & revisions ~12 million key target surgeries a year across the US and major Europe hip replacements & revisions surgeries associated with an ageing population are growing at 6-7% per annum major abdominal surgery 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) caesarean sections thoracic vascular sales potential: $250+m exploring scope for premium pricing 17 DepoDur - 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 SkyePharma’s share of sales 20-60% based on combined sales of DepoDur and Propofol IDD-D >50% share if combined sales >$250 mn 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 18 Foradil 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) 19 Propofol IDD-D Endo, SkyePharma 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 North America: Endo (same terms as DepoDur) Europe/Japan: licensees to be appointed est. sales potential for Propofol IDD-D: ~$200 mn 20 Well-stocked pipeline licence or partner ORAL product GlaxoSmithKline Sanofi-Synthelabo Roche Therabel Mundipharma Ratiopharm GlaxoSmithKline Critical Therapeutics Merck KGaA Kowa Undisclosed King Paxil CR Xatral OD/Uroxatral Madopar DR Coruno Nifedipine Diclofenac Requip zileuton Undisclosed Statin NK-104 Undisclosed Altace feasibility Ph.I Ph.II SkyePharma Ph.III filed Client products approved marketed PULMONARY Novartis AstraZeneca SkyePharma Novartis SkyePharma Foradil Certihaler Pulmicort HFA Formoterol HFA QAB 149 Formoterol Combi INJECTABLE Enzon/MundiPharma/Nippon S’yaku Endo / Medeus Astralis * SkyePharma SkyePharma GeneMedix Chugai DepoCyt DepoDur Psoraxine * DepoBupivacaine HGH Interferon alpha-2b Undisclosed * SkyePharma has an option on world rights for PsoraxineTM, exercisable at the end of Phase II TOPICAL Quintiles/Shire Trigenesis Solaraze Multiple Status is most advanced project SOLUBILISATION SkyePharma Endo / SkyePharma SuperGen Baxter Fenofibrate Propofol IDD-D Busulfan Multiple 21 Newsflow 2004 – further progress Filings Requip OD Europe (US 2005) Licence agreements DepoDur (Europe) Pulmonary product package Unnamed pipeline product Dermatology assets Propofol IDD-D (Europe) DepoBupivacaine (Europe) Clinical data publications (by partners) DepoDur 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 approval 18 May DepoDur UK Launch of DepoCyte Europe Foradil Certihaler US FDA “approvable” Oct ’03 Foradil Certihaler Europe Clinical trial progression Pulmicort HFA-MDI Propofol IDD-D Formoterol HFA-MDI Formoterol+fluticasone HFA-MDI Zileuton (Critical Therapeutics) Psoraxine (Astralis) DepoBupivacaine Ph III end Ph III start Ph III start Ph II/III start Ph III start (COPD) Ph II start Ph II start 22 Investment highlights Strategic focus on royalties rather than upfront payments Ten FDA-approved products validate drug delivery technologies - DepoDur approval demonstrates successful development capability Changing quality of earnings driven by rising royalties from Paxil CR, Xatral® OD/Uroxatral®, Solaraze, DepoCyt® - with Foradil® Certihaler®, DepoDur, HFA-formoterol & Propofol IDD-D close behind Strong near-term clinical pipeline 1 Filed, 4 x Phase III, 3 x Phase II Two major product launches expected in H2 ’04 23 Investor relations contacts: London Peter Laing, Director of Corporate Communications 44-(0)207-491-1777 [email protected] New York Sandra Haughton, US Investor Relations Manager 1-212-753-5780 [email protected] …and please visit our website NASDAQ:SKYE LSE:SKP www.skyepharma.com