Biocompatibles Presentation 20091203
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Biocompatibles International plc Agenda • Overview • Key Programmes: Overview and Update: – Oncology Products: Drug-Eluting Beads – Oncology Products: Radiation Seeds – Licensing: Medtronic – Licensing: CellMed – AstraZeneca, Merz, Stroke • Financial Review and 2009 Goals Five Key Points for New Investors • Business Overview – Oncology Products : Proprietary Medical Devices: • Drug-Eluting Beads • Radiation Seeds – Licensing : Ambitious R&D/Partnering programmes: • AstraZeneca • Medtronic • Sales of £25m, growing at 30%+ per annum • Dividend of 5p/share paid in May 2009 • Contribution to R&D of £12m. Net R&D of £14m* • Net funds of £30m…market cap. of £95m** * Illustrative doubling of half-year figures ** Market cap. based on share price of 241.5p on 20 November, 2009 Two Divisions in Three Locations GROUP Oncology Products Licensing US and UK Mainly Germany Sales: £18m Sales: £7m Not Partnered Bead Brachytherapy AstraZeneca Products Products Medtronic Stroke Merz RNAi Group Sales £m 15 Mid Guidance 10 CellMed Licensing BrachySciences Beads 5 0 H1 2005 H2 2005 H1 2006 H2 2006 H1 2007 H2 2007 H1 2008 H2 2008 H1 2009 H2 2009 Sales Growth and Data are driving Value • 2009-11: • Dividend • Financial Guidance and Goals • Drug-Eluting Beads: • Continuing the growth • China and Japan • Accumulating clinical data • Acquisitions / Business Development • Towards break-even and profit • 2011-12 inflection points – AstraZeneca potential option exercise – Drug-Eluting Beads breakthrough: • SPACE • PARAGON Studies Agenda • Overview • Key Programmes: Overview and Update: – Oncology Products: Drug-Eluting Beads – Oncology Products: Radiation Seeds – Licensing: Medtronic – Licensing: CellMed – AstraZeneca, Merz, Stroke • Financial Review and 2009 Goals Drug-Eluting Beads address a clear Need • Beads Overview – Beads that can better deliver current chemotherapy drugs – local, slow release • Lower side effects • Lower cost • Higher response – BII branded product…approved as a medical device • HCC (Primary Liver Cancer) – Estimated 85-90% of current Drug-Eluting Bead (DEB) sales – 45k patients in US/EU15 – Trial Results: PRECISION V, Phase II – Trial Plan: Bayer (+Nexavar), • Liver Metastases from Colo-Rectal Cancer – Estimated 5-10% of current DEB sales – 200k patients in US/EU15 – Trial Results: Phase II presented at ASCO GI – Trial Plan: Paragon I, II and III • Other Liver Metastases – Estimated 0-5% of current DEB sales – “Significant Opportunity” Oncology Implant Market is growing fast Units Sold - In Market Value - In Market DEB Share 31% 70,000 70 60,000 60 DEB 50,000 50 Share DEB 26% 40,000 40 DEB Share ££ M M UU n n its its 18% 30,000 30 Share 16% 20,000 20 10,000 10 0 0 2006 2007 2008 2009 H1 2006 2007 2008 2009 H1 Sirtex BioSphere Biocompatibles Sirtex BioSphere Biocompatibles Market growth: 50% 54% 68% Data excludes products from two companies whose sales are not disclosed in annual accounts. 2009E – Annualised based on reported data Early Trial Results have the right Profile Quality of Life One Year Survival 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% DEBIRI (n=28, 52 treatments) FOLFIRI (n=28, 224 treatments) € 12,000 € 10,250 € 10,000 € 8,000 € 6,000 € 4,500 € 4,000 Data Presented at ASCO GI, 2009: Fiorentini et al € 2,000 € - Cost per procedure SPACE: Partnering with Bayer • “…Nexavar® (sorafenib) tablets…a novel, oral multiple kinase inhibitor…targets proteins involved in…tumor cell proliferation and angiogenesis… collaboration with Bayer... • Nexavar…approved in more than 70 countries worldwide for...advanced kidney cancer, and in more than 60 countries for…liver cancer. • Nexavar has over $1 Billion in cumulative sales to date.” Source: http://www.onyx-pharm.com/wt/page/about SPACE: Partnering with Bayer Hepatocellular Carcinoma (HCC) Non-resectable TACE with DC Bead + Placebo TACE with DC Bead + Nexavar 150 patients 150 patients • Bayer leads communication • First Patient Recruited • Note (not SPACE trial): Presentation of Hopkins data at AASLD – Boston, 2 November 2009 Paragon Louisville: Working with Avastin Hepatic Colo Rectal Metastases First Line Non-resectable Folfox Avastin + DEBIRI 10 patients Folfox Avastin Folfox Avastin + DEBIRI 30 patients 30 patients • Physician IDE approved • 6 patients recruited Paragon II: Aiming for more cured Patients Hepatic Colo Rectal Metastases First Line Resectable DEBIRI 20 patients Resection • 13 patients recruited • Promising histology • Presentation planned at ASCO 2010 • Randomised trial under discussion Real World Registry: Many Cancers Treated mCRC Other Cancers 146 117 Carcinoid Cholangio Breast Lung Melanoma Oesophagus HCC Renal 159 Bladder Pancreas Sarcoma Cervix SCC Anal Other Cancers Salivary Breakdown by type Adrenal Adrenal Ovarian Duodenum Thyroid 0 5 10 15 20 25 30 Number of Patients Agenda • Overview • Key Programmes: Overview and Update: – Oncology Products: Drug-Eluting Beads – Oncology Products: Radiation Seeds – Licensing: Medtronic – Licensing: CellMed – AstraZeneca, Merz, Stroke • Financial Review and 2009 Goals BrachySciences Acquisition: On Track • Medical device business in Oxford, Connecticut • Implantable seeds delivering radiation for Prostate cancer • Own small sales force • Established market greater than $150m • AnchorSeed product is key to growth • “Beads and Seeds” • 15% sales growth at c.c. • Profit ahead of 2008 Agenda • Overview • Key Programmes: Overview and Update: – Oncology Products: Drug-Eluting Beads – Oncology Products: Radiation Seeds – Licensing: Medtronic – Licensing: CellMed – AstraZeneca, Merz, Stroke Licensing: Medtronic Royalty underpins Dividend Overview and Update • PC Technology licence to Medtronic, via Abbott • For Endeavor® Drug-Eluting Stent • 1.5% royalty in $4 billion market • £2m dividend, 5p/share paid in May 2009 • Revenues have flattened “The Board expects to continue to pay the Royalty Dividend annually for as long as Medtronic sustains an appropriate level of sales of its Endeavor Drug-Eluting Stent, on which Biocompatibles earns a 1.5% royalty. The Board also intends that thereafter the Company would pay a dividend from profits, though at this time there can be no certainty that this transition can be achieved as planned”. Company RNS May 2008 Agenda • Overview • Key Programmes: Overview and Update: – Oncology Products: Drug-Eluting Beads – Oncology Products: Radiation Seeds – Licensing: Medtronic – Licensing: CellMed – AstraZeneca, Merz, Stroke • Financial Review and 2009 Goals Licensing: Significant Potential with AstraZeneca • AstraZeneca has option to license GLP-1 diabetes drug • Phase I and IIa programme fully funded by €8.8m deal • €25m upfront licence fee at end of Phase IIa or earlier • Further milestones of up to €294m + single to mid teens royalties • Phase I and Phase IIa plan well- advanced for 2010 H1 first patient Licensing: Dermal Filler Product Launch • Novabel named and ready for 2010 launch • Positive market feedback • Manufacturing investment, funded by Merz • Contributes to CellMed financials H1 2009 Financial Summary • Revenue of £14.0m • Gross profit of £10.9m or 78% • Contribution to R&D of £5.9m – Sixth consecutive half year of Contribution to R&D costs • Operating loss of £1.1m • Overall cash outflow £2.2m pre dividend • Net funds of £29.5m • 2009 Guidance revised: – Sales £24m-£26m, increased from £22m-£24m – Cash £28m at year-end, increased from £27m Revenue & Cash 2009 Guidance on Track Revenue • Guidance 30 25 – Revenue £24-26m 20 15 increased from £22-24m £ m 10 5 0 – Closing cash balance £28m 2005 2006 2007 2008 2009 increased from £27m Total Revenue 2008 Mid-Guidance – Cash expenditure ~5.6m Closing Cash 50 including £2m dividend 40 30 £m 20 10 0 2005 2006 2007 2008 2009 • Shares in issue 39.2m Net Funds Guidance Stable Shareholders Hunter Hall Investment Management Limited 28% INVESCO plc 25% Aberforth Partners LLP 14% Board/CellMed and BrachySciences management 8% Subtotal 75% Others 25% Total 100% As notified – 23 October 2009.