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NASDAQ:SKYE LSE:SKP www.skyepharma.com UK tel: +44 (0)207 491 1777 US tel: +1 (212) 753 5780 Corporate Presentation Michael Ashton Chief Executive 29 September 2005
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29 September, 2005 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 2005 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 $1.74 = £1 has been used throughout. These dollar equivalent numbers do not imply restatement from UK GAAP to US GAAP. This presentation was updated on 26 September 2005
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29 September, 2005 3 SkyePharma in brief UK-domiciled speciality pharmaceutical company drug delivery industry leader originally founded 1983, IPO 1996 listed London (SKP), New York (ADR, SKYE) market capitalisation £250/$445 mn 29 Sep: 40p/share, $7.25/ADR, 628 mn shares in issue largest investors Fidelity (13%), Insight (10%)
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29 September, 2005 SkyePharma business outline
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29 September, 2005 5 What is drug delivery? Not “truck” delivery!
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29 September, 2005 6 Drug delivery – making good drugs better Key advantages of drug delivery: greater efficacy (less fluctuation in blood levels; targeted delivery) more convenient ( better compliance) reduced side-effects
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29 September, 2005 7 Drug delivery – making good drugs better SkyePharma normally works on drugs already proven safe and effective low risk of clinical failure short development times low development costs contrast with biotech! SkyePharma relies on partners for sales and marketing
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29 September, 2005 8 SkyePharma delivery technologies Oral most widely-used drug delivery route (~50% of all drugs taken orally) Geomatrix : multi-layer tablet technology with barrier layers around active drug matrix flexible release profile; no vehicle residue; ease of manufacture on conventional tablet presses Sustained-release injectable DepoFoam : active dissolved in water within multivesicular liposome particles Biosphere : active dispersed in dry starch core within PLG shell Pulmonary HFA-MDI: metered-dose aerosol inhaler powered by non-CFC propellant (HFA) SkyeHaler : multi-dose dry-powder inhaler associated formulation technologies to ensure dose-to-dose consistency Solubilization insolubility growing problem in drugs industry reducing particle size raises solubility - but reagglomeration must be prevented multiple technologies to improve bioavailability Triglide is first approved product based on IDD technology Topical multiple transdermal technologies - now licensed to Trigenesis (Dr Reddy’s)
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29 September, 2005 9 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 $100+ mn Royalty rate Low 3-7% High 20-50%
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29 September, 2005 10 London (HQ) Basel Lyon 2 FDA/EMA approved manufacturing sites San Diego Global infrastructure New York >400 staff worldwide of which 50% scientists / clinical staff Osaka Global business development coverage
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29 September, 2005 11 A transforming business Integrated pharmaceutical developer Drug delivery service provider Developing own products for out-licence
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29 September, 2005 12 Flutiform - out-licence negotiations history discussions with potential marketing partners have been on the basis of development funding by the partner Dec ’03 - offer involving milestone payments of $90 mn - rejected as inadequate Apr ’05 – non-binding Heads of Terms negotiated with major global pharma company for US rights to Flutiform up to $160 mn in milestone payments and development cost reimbursement double digit royalties – with escalating rate on sales thresholds Sep ’05 – contract negotiations terminated April announcement attracted substantial additional interest, leading to advanced discussions with another major global pharma company for worldwide rights (and with other companies for other territories)
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29 September, 2005 13 Flutiform - keeping development on track proceed with Ph III development at our own expense allows us to keep development under our control reduces risk of delays to market entry, jeopardising sales potential still our intention to appoint licensee(s) – but now during/after Ph III removal of partner funding obligation, elimination of majority of development risk and proximity to launch should result in much more favourable economics will seek to retain co-promotion rights in line with medium-term strategy of vertical integration
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29 September, 2005 14 Global asthma market 2003-2010e Source: ING “Asthma & COPD” July 2004
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29 September, 2005 15 Flutiform ™ opportunity formoterol / fluticasone combination in HFA-MDI for asthma and COPD optimal combination of steroid + LABA expected to enter US market 2009 competition: GSK’s Advair (2004 world sales $4.6 bn) and Symbicort (2004 world sales $800 mn – not on US market) US regulatory entry barriers very steep even though Symbicort filed 23 Sep 05, market entry thought unlikely before 2008 at earliest no other combination competitors expected before 2012 at earliest our estimate is $1.5 bn peak sales potential in the hands of an appropriate partner
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29 September, 2005 16 Flutiform ™ – the risks of delay in negotiations potential licensees have not disagreed on the likely value of Flutiform ™ … …but time to market is critical we expect Flutiform to be the #2 or #3 steroid / LABA combination to reach the US market (in 2009) other competitors (proprietary or generic) will follow eventually – but not before 2012 at the earliest partner control of Flutiform ™ development could result in delays some partners have wanted results from certain studies before proceeding with others risk of “big pharma” bureaucracy SkyePharma is confident in its ability to meet timelines long experience with development of pulmonary products, including formoterol and budesonide very encouraging Phase II data for Flutiform ™ manufacture successfully scaled up MDI poses less regulatory issues than a DPI DepoDur track record – filed on target in Jul ‘03, first cycle FDA approval May ’04 conclusion: fund and control development ourselves
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29 September, 2005 17 Flutiform ™ – Phase III trials start date: Q1 ‘06 filing: mid ‘07 expected FDA approval H1’09 assumes 18 month review instead of statutory 10 months development cost from now to filing: $54 mn
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29 September, 2005 18 Headline news H1 ‘05 US approval for Triglide ™ (fenofibrate) launched 15 July new agreement with GlaxoSmithKline on Paxil CR Paxil CR returned to US market 27 June DepoDur approved in UK (conditional) DepoBupivacaine licenses Apr ‘05: Mundipharma for all territories outside North America and Japan Foradil Certihaler approved in Germany launched Sep ‘05 Pulmicort HFA-MDI filed in first European market
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29 September, 2005 19 Major marketed products Paxil CR (GlaxoSmithKline) Xatral OD / Uroxatral (Sanofi-Aventis) DepoDur (Endo; Zeneus) Triglide (First Horizon) Solaraze (Bradley; Shire) DepoCyt (Enzon; Mundipharma)
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29 September, 2005 20 Paxil CR – new GSK agreement Apr ‘05 4 Mar ’05 - FDA halts US distribution of Paxil CR cites manufacturing problems at GSK’s plant in Puerto Rico 28 Apr ’05 - amended agreement with GSK GSK to increase the royalty rate on Paxil CR from 3% to 4% $10 mn cash payment upfront in lieu of higher royalty rate on sales of Paxil CR 8 Sep ’03 – 4 Mar ’05 GSK to pay SkyePharma 4% of budgeted US sales of Paxil CR from 4 March ‘05 until Paxil CR returns to the market GSK to pay SkyePharma 4% of actual sales thereafter subject to other conditions of the agreement SkyePharma to drop all legal / arbitration action 27 Jun ‘05 - Paxil CR returns to US market
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29 September, 2005 21 Paxil CR GlaxoSmithKline Geomatrix version of GSK’s SSRI Paxil ® (paroxetine) for depression targets release to lower intestine, reducing nausea and improving compliance up to 4 March 2005, Paxil CR held ~7% of the US SSRI antidepressant new prescription market launched in USA Apr ‘02 generic competition for Paxil ® began Sep ’03 Rx for Paxil CR cannot be substituted - but generics exert indirect price pressure Paxil CR sales: 2003: $635 mn (all in USA) 2004: $725 mn (USA $710 mn +13% CER + $15 mn of non-US sales) H1 ’05 $126 mn (-65% CER) Paxil CR off US market 4 Mar – 27 Jun’05 SkyePharma royalty: 4% (3% until Apr ’05)
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29 September, 2005 22 Xatral ® OD/Uroxatral ® Sanofi-Aventis once-daily Geomatrix formulation of alfusozin for BPH, with two USPs: highly uroselective (avoids postural hypotension) no ejaculatory side-effects (cf. Flomax) marketed in Europe & ROW since 2000 USA: Uroxatral launched Nov ’03 primary care launch Mar ’04 main competitor Flomax (tamsulosin) Uroxatral now holds >11% of combined TRx for Flomax and Uroxatral AUR indication: approved Europe; Ph III US adjuvant (after surgery) and prophylaxis 2004 world sales (all versions) €281 mn +28% CER H1’05 €157 mn +16% CER SkyePharma return on sales: mid-single digits
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29 September, 2005 23 DepoDur Endo / Zeneus sustained–release injectable morphine for relief of post-operative pain provides effective relief of pain for 48 hours after surgery (period of peak post-operative pain) avoids catheter-related problems with conventional short-acting morphine potential to replace conventional infusion pumps (major source of equipment failure) USA (Endo Pharmaceuticals) approved by FDA May ’04 (NB first-cycle approval) launched by Endo Dec ‘04 – hospital sales force 70 targetting 1000 key hospitals priced at premium to conventional analgesia expected to be on ~50% of hospital formularies by end-05 H1 ’05 sales $2.3 mn Europe (Zeneus Pharma) filed Nov ’03 (EU mutual recognition procedure with UK as reference country) UK marketing authorisation Apr ’05 – subject to conditions once conditions met, approvals in other EU countries to follow over next 6-12 months Zeneus has pan-European hospital sales force of 150
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29 September, 2005 24 DepoDur - licence terms endorse potential Licence terms for DepoDur SkyePharma bears development and manufacture costs partner bears sales and marketing costs Skyepharma receives increasing share of sales as partner’s revenues increase most of milestone payments also related to revenue targets TerritoryPartnerProducts Milestones (maximum if all targets met) SkyePharma’s share of sales Min Max North America Endo Pharmaceuticals Dec ’02 DepoDur Propofol IDD-D + right of first negotiation for DepoBupivacaine $120 mn 20% 60% of combined sales of DepoDur and Propofol IDD-D Europe Zeneus Pharma Mar ’04 DepoDur €100 mn35% 50% rights for other territories not yet assigned
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29 September, 2005 25 Triglide ™ First Horizon Triglide (fenofibrate) launched 15 July ‘05 approved by FDA May ’05 SkyePharma’s IDD ® -P solubilization technology allows Triglide to be taken with or without food fenofibrate a key treatment for lipid disorders beneficial dual lipid-modulating effects – TG & LDL-C but HDL-C fenofibrate “best in class” fibrate ( NCEP guidelines 2005 ) ~$1 bn US market for fenofibrate (growth in 2004: 38%) highly unsatisfied market – most patients with elevated lipids either untreated or undertreated potential synergy between fenofibrate and statins presents major opportunity First Horizon successful US specialty pharma company 400+ sales force dedicated to US cardiovascular market good track record of capturing market share from heavy-hitting competitors SkyePharma receives up to $50 mn in milestones and 25% share of sales
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29 September, 2005 26 Solaraze Bradley / Shire topical gel formulation of diclofenac for actinic keratosis AK is early form of squamous cell carcinoma alternative treatments for AK are painful and disfiguring SkyePharma formulation “holds” active in upper layers of skin marketed by Bradley in North America, Shire in Europe / Australasia SkyePharma received payment of $5 mn for transfer from Quintiles to Bradley in 2004 2004 global in-market sales $18 mn US $12 mn (2004 sales pattern disrupted by change of licensee) Europe $6 mn H1’05 sales: ~$10 mn filed in Australia by Shire Dec ’04 SkyePharma royalty: mid-teens
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29 September, 2005 27 DepoCyt Enzon / Mundipharma intrathecal injectable cytarabine for lymphomatous meningitis severe complication of lymphoma Depofoam formulation extends period between injections from 1-2 days to 2 weeks treatment can be on out-patient basis marketed by Enzon in US, Mundipharma in Europe (as DepoCyte ) 2004 global in-market sales doubled to $8 mn US sales $6.5 mn (+60%) Europe sales $1.5 mn (first year) H1’ 05 sales: $5.6 mn (+105%) US $3.5 mn (+40%); Europe $2.1 mn (vs $0.2 mn) Ph IV trial in solid tumour patients now completed most common type of neoplastic meningitis expect to file data with FDA mid-05 SkyePharma share of sales: 35%
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29 September, 2005 28 Key near-term pipeline products Foradil Certihaler DepoBupivacaine ™ Propofol IDD-D ™
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29 September, 2005 29 Foradil Certihaler Novartis / Schering-Plough formoterol (fast-onset, long-acting bronchodilator) for asthma / COPD uses SkyePharma’s multi-dose dry-powder inhaler (DPI) SkyePharma developed both device and formulation formulation keeps powder dry, ensures accurate consistent dose now also being used in second collaboration with Novartis - QAB149 (indacaterol) Schering-Plough to market in key US market, Novartis elsewhere H1 ’05 sales of Foradil in inconvenient single-dose DPI: $174 mn FDA “approvable” letters issued Oct ’03, Dec ’04 Novartis has filed additional data requested – FDA decision due early ‘06 approvals began H1 ’04 (now 6 in Europe, 6 in Latin America, South Africa…) launched in Germany Sep ’05 – other European launches to follow SkyePharma return on sales: ~10% made up of royalty + manufacturing return
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29 September, 2005 30 DepoBupivacaine Mundipharma long-acting injectable formulation of widely-used local anaesthetic designed to provide 48-72 hours of local pain relief especially suitable for control of post-operative pain after out-patient surgery >65% of all surgical procedures in US now done on out-patient basis current local anaesthetics short-acting; home recovery precludes use of most narcotic analgesics DepoBupivacaine complements DepoDur (for pain relief after in-patient surgery) Ph II trial started late ’04 – results Q4 ’05 Ph III to start H1’ 06 – target filing end-07 TerritoryPartner Upfront payment Development Funding Milestones (maximum if all targets met) SkyePharma’s share of sales North America Endo Pharmaceuticals Right of first negotiation on completion of Phase II Europe + RoW Mundipharma Apr ’05 $10 mnSkyePharma$80 mn 35% (30% outside Europe) licenses for other territories still under negotiation
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29 September, 2005 31 Propofol IDD-D SkyePharma / Endo proprietary improved version of propofol (AstraZeneca’s Diprivan) widely-used injectable anaesthetic and sedative potential for microbial contamination requires aseptic technique and limits use to 6 hours despite presence of preservative SkyePharma IDD-D technology stabilises emulsion formulation unique inherently antimicrobial no need for a preservative 2% emulsion (= lower injection volume, reduced lipid load) not a generic designed for continuous uninterrupted 24-hour sedation licensed to Endo for US market in discussion with FDA on design of Ph III trials
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29 September, 2005 32 SkyePharma’s pipeline Triglide Propofol IDD-D Multiple First Horizon Endo / SkyePharma Baxter SOLUBILISATION Solaraze Multiple Bradley/Shire Dr Reddy’s (Trigenesis) TOPICAL DepoCyt DepoDur Psoraxine * DepoBupivacaine HGH Interferon alpha-2b GCSF Enzon/MundiPharma/Nippon S’yaku Endo / Zeneus Astralis * SkyePharma/MundipharmaSkyePharma SkyePharma INJECTABLE Foradil Certihaler Pulmicort HFA formoterol HFA QAB 149 Flutiform Novartis AstraZeneca SkyePharma Novartis SkyePharma Paxil CR Xatral OD Madopar DR Coruno Cordicant-Uno Diclofenac Requip 24hr zileuton CRUndisclosed GlaxoSmithKline Sanofi-Aventis Roche Therabel Mundipharma Ratiopharm GlaxoSmithKline Critical Therapeutics Nitec Undisclosed ORAL marketedapprovedfiledPh.IIIPh.IIPh.Ifeasibilityproductlicensee or partner SkyePharmaClient products * SkyePharma has a right of first negotiation to acquire world rights for Psoraxine TM PULMONARY Status is most advanced project
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29 September, 2005 33 2005 filings Requip ® 24hr - GlaxoSmithKline once-daily oral formulation of GSK’s Requip ® (ropinirole) dopamine agonist for Parkinson’s disease therapeutic benefits (shorter titration schedule) improved compliance SkyePharma managed clinical studies for GSK SkyePharma royalty: mid-single digits Pulmicort ® HFA-MDI - AstraZeneca (for Europe) Pulmicort ® (budesonide) in HFA-powered aerosol inhaler widely-used inhaled steroid for asthma will allow AZN to withdraw Pulmicort ® CFC-MDI filed in first European market 28 Jun ’05 SkyePharma royalty: mid-teens
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29 September, 2005 Results for six months ending 30 June 2005 presented in £ sterling and IFRS
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29 September, 2005 35 Turnover Turnoverup 3% Contract developmentdown 7% Royalties up 17% Manuf. & distributionup 19% Deferred contract development income£13.2m To reverse in H2 2005£8.5m £m 25.3 35.1 36.0 6 months
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29 September, 2005 36 Turnover (2004 and prior years restated to IFRS for comparative purposes) CAGR H1’96 – H1’05: 37% Collaboration equity H1 H2 £m 9.0 13.8 16.7 22.4 24.1 44.2 42.6 66.5 36.0 75.2
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29 September, 2005 37 R&D – sustained investment H1 05 R&D down by £3.5m (-24%) £3.1m on Flutiform £3.4m on DepoBupivacaine £1.5m on Other Injectable £0.4m on Budesonide HFA £1.3m on Other Inhalation R&D target FY05: £27m Flutiform* £11m DepoBupivacaine £8m * not now to be reimbursed £m 16.4 10.9 6 months Topical Oral Enhanced Solubilisation DepoDur 14.4 Propofol
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29 September, 2005 38 Operating result Key variables: Royalties 33% of Turnover – up 17% Gross profit down 9% R&D down 24% Operating loss before exceptionals down 77% Operating loss after exceptionals £0.3m (H1 2004: £0.3m profit) EBITDA £3.3m down 22% H104H105 turnover35.136.0+3% gross profit23.521.4-9% R&D14.410.9-24% operating profit/(loss) 0.3(0.3)- net loss(8.7)(9.3)+7% EPS (pence)(1.4)p(1.5)p+7% EBITDA4.23.3-22%
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29 September, 2005 39 Net Cash £m OverdraftCash Net Cash Debt: £11.3m of debt (excl. convertible) - £6.8m Swiss mortgage £89.6m convertible debt £69.6m conversion May 2024 Conversion price £1.00 £20.0m conversion June 2025 Conversion price 81p December 2003 December 2004 June 2005 -1.2
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29 September, 2005 40 Cash flow H1’05 £m Total: +3.7m Operational cash inflow Issue of convertible bond Repayment of convertible bond Debt repaid CAPEX Interest Other
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29 September, 2005 41 Newsflow targets 2005 Product approvals/launches: DepoDur UK/EU Apr ’05 (with conditions) Foradil Certihaler US FDA “approvable” Dec ’04 Foradil Certihaler EU launched in Germany Triglide (First Horizon) US launch Jul ‘05 Licence agreements: Propofol IDD-D (Europe) DepoBupivacaine (Europe) Mundipharma Apr ‘05 DepoBupivacaine (Japan) DepoBupivacaine (US) Endo has right of first negotiation at end Ph II Pipeline progress: Pulmicort HFA-MDI*File EU Jun ‘05 Requip 24hr *File US/EU DepoCyt (2nd indication)File EU DepoCyt (2nd indication)File US zileuton CR (asthma) *File US now H1’06 [formoterol HFA-MDI Ph III start] under strategic review zileuton CR (COPD) * Ph III start Flutiform HFA-MDIPh III start now Q1’06 QAB 149 *Ph III start now H1’06 DepoBupivacaine Ph II end * Partner’s responsibility
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29 September, 2005 42 Investment highlights strategic focus on royalties rather than upfront payments royalties now over one-third of revenues changing quality of earnings, driven by rising royalties from strong pipeline 11 FDA approvals validate our drug delivery technologies DepoDur first-cycle FDA approval demonstrates successful development capability 2 launches in 2005 (Triglide and Foradil Certihaler) 4 products to be filed 2005 5 products now in Phase III - 5 products in Phase II no need to scale cost-base significantly for higher revenues Paxil CR , Xatral ® OD/Uroxatral ®, Solaraze ®, DepoCyt ®, DepoDur , Triglide with Foradil Certihaler , HFA-formoterol, zileuton CR, Requip 24hr, Propofol IDD- D , Flutiform , DepoBupivacaine …..close behind
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29 September, 2005 Appendix Flutiform ™ clinical trials
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29 September, 2005 44 FlutiForm ™ – Ph I and Ph II completed
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29 September, 2005 45 FlutiForm ™ Phase II – trial design double-blind randomised 6-way crossover study FlutiForm ™ HFA pMDI 100/10 g FlutiForm ™ HFA pMDI 250/10 g fluticasone (Flixotide) HFA pMDI 250 g + formoterol (Foradil) DPI 12 g fluticasone (Flixotide) HFA pMDI 250 g formoterol (Foradil) DPI 12 g placebo each patient received four of six treatments N=64 (7 treatment centres in UK)
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29 September, 2005 46 Ph II result: change from baseline in actual FEV 1 (ITT Population)
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29 September, 2005 47 FlutiForm ™ Phase II - efficacy results comparable efficacy of FlutiForm ™ 100/10 g and FlutiForm ™ 250/10 g compared with concurrent use of the individual components and with formoterol (Foradil) alone superior efficacy of FlutiForm ™ 100/10 g and FlutiForm ™ 250/10 g when compared with placebo no drug-drug interaction or apparent changes in the efficacy profile of the components in the FlutiForm ™ formulation rapid onset (<5 min) of bronchodilation with FlutiForm ™ 100/10 g and FlutiForm ™ 250/10 g bronchodilator effect well maintained for ~12 hours, supporting proposed twice-daily dosing
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29 September, 2005 48 FlutiForm ™ – further clinical development plan
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29 September, 2005 49 Flutiform ™ - Ph III trial costs ($ mn)
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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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