Oxford Biomedica Delivering Commercial Gene-Therapy Vector
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31st March 2017 Pharmaceuticals & Biotechnology Oxford BioMedica Delivering commercial gene-therapy vector OXB is a specialist gene and cell therapy viral-vector biopharmaceutical company. It offers vector manufacturing and development services, whilst retaining its own proprietary therapeutic candidates. Above service-fees, OXB will receive royalties Source: Fidessa on commercial products developed with its LentiVector® platform: extensive IP, facilities, and know-how for production and development of lentiviral vectors to Market data generate gene-based therapies. OXB intends to out-license its five clinical EPIC/TKR OXB candidates and to continue investment in R&D. Bioprocessing royalties are likely Price (p) 5.2 to result in significant upside potential in the near future. 12m High (p) 6.5 12m Low (p) 3.0 ► Strategy: Oxford BioMedica has four strategic objectives: delivery of process Shares (m) 3,088.2 development services which embed its technology in partners’ commercial Mkt Cap (£m) 159.0 products; commercial manufacture of lentiviral vector; out-licensing of EV (£m) 178.1 proprietary candidates; and investment in R&D and the LentiVector platform. Free Float 65% Market LSE ► Revenues: Bioprocessing and process development command fees-for-service, with process development also incurring upfront, milestone and incentive Description payments plus licensing income and royalties on commercial products. Out- Oxford BioMedica is a UK-based licensed candidates will deliver licensing fees plus high royalties if successful. biopharmaceutical company specializing in cell and gene therapies developed using lentiviral vectors, ► Valuation: An EV/sales multiple of 4x prospective sales for the bioprocessing gene-delivery vehicles based on virus and process development services is readily justified, which generates a value particles. In addition to vector of £188m. Adding in the risk-adjusted NPV of the potential royalty stream development and manufacture, OXB (£46m) suggests a group value of £225m, or 7.5p per share. has a pipeline of therapeutic candidates and undertakes innovative ► Risks: There are inherent risks in clinical trials and commercialisation, pre-clinical R&D in gene-medicine. particularly in innovative areas such as gene therapy. Oxford BioMedica does Company information not have a controlling stake in commercialisation of partner candidates, and its CEO John Dawson current strategy is contingent on commercial vector manufacture for partners. CFO/elect Tim Watts/Stuart Paynter Chairman Lorenzo Tallarigo ► Investment summary: OXB is at a very interesting juncture. Heavy investment in state-of-the-art GMP manufacturing facilities for cell and gene therapies 01865 783 000 www.oxfordbiomedica.co.uk places it on the cusp of generating significant service income and royalties, at a time when it is looking to partner its own clinical candidates. Forecasts for this Key shareholders transformed company suggest that it will turn EBITDA positive in 2017 and Directors 0.5% become profitable overall at the EBIT level in 2018. Vulpes 18.9% M&G 18.1% Aviva 9.3% Financial summary and valuation Joy Group 7.6% Year end Dec (£m) 2014 2015 2016 2017E 2018E 2019E Sales 13.62 15.91 27.78 38.8 47.0 54.0 Diary EBITDA -9.29 -11.73 -6.78 2.3 6.0 11.4 May-17 AGM Underlying EBIT -10.39 -13.35 -10.45 -2.2 1.5 6.9 Sept-17 Interims Reported EBIT -10.61 -14.08 -11.32 -3.1 0.5 5.8 Underlying PTP -10.58 -16.25 -19.44 -7.3 -3.6 1.8 Statutory PTP -10.80 -16.98 -20.31 -8.2 -4.6 0.7 Analysts Underlying EPS (p) -0.42 -0.48 -0.57 -0.09 0.04 0.22 Statutory EPS (p) -0.43 -0.51 -0.60 -0.12 0.01 0.18 Martin Hall 020 7148 1541 Net (debt)/cash 13.20 -17.90 -19.05 -25.0 -26.0 -21.8 [email protected] Capital increase 22.81 0.14 17.50 0.1 0.1 0.1 Dorothea Hill 020 7148 1433 P/E (x) - - - -58.8 116.7 23.7 [email protected] EV/sales (x) - - - 78.8 29.9 15.7 Gregoire Pave 020 7148 1434 Source: Hardman & Co Life Sciences Research [email protected] Disclaimer: Attention of readers is drawn to important disclaimers printed at the end of this document Oxford BioMedica Table of contents Executive summary ............................................................................................... 3 Overview of Oxford BioMedica ............................................................................. 7 Gene editing .......................................................................................................... 9 Background ............................................................................................................ 9 Cell and gene therapy R&D .................................................................................... 9 Vector manufacture ............................................................................................. 15 OXB technology ................................................................................................... 17 LentiVector® platform .......................................................................................... 17 Priority wholly-owned products ........................................................................... 19 Other candidates .................................................................................................. 22 OXB pre-clinical research ..................................................................................... 23 Out-licensed products ......................................................................................... 24 Bioprocessing partnerships ................................................................................. 25 Unparalleled manufacturing capacity .................................................................. 25 With Novartis… ..................................................................................................... 25 With Orchard Therapeutics… ............................................................................... 27 With Immune Design… ......................................................................................... 27 Competitive landscape ........................................................................................ 29 Bioprocessing competition ................................................................................... 29 Parkinson’s disease advanced therapies .............................................................. 31 Commercial strategy ........................................................................................... 33 Updated strategy .................................................................................................. 33 Regulatory progress ............................................................................................. 33 Intellectual property............................................................................................. 33 Market potential .................................................................................................. 33 Financials & Investment case............................................................................... 36 Profit & Loss ......................................................................................................... 36 Balance sheet ....................................................................................................... 38 Cashflow ............................................................................................................... 39 Valuation .............................................................................................................. 40 Company matters ................................................................................................ 44 Financing history .................................................................................................. 45 Share capital ......................................................................................................... 46 Risks .................................................................................................................... 48 Glossary ............................................................................................................... 49 References........................................................................................................... 50 Disclaimer ........................................................................................................... 51 Hardman Team .................................................................................................... 52 31st March 2017 2 Oxford BioMedica Executive summary Gene-medicine pipeline and bioprocessing services Oxford BioMedica: specialising in Oxford BioMedica is a biopharmaceutical company specialising in cell and gene lentiviral vectors… therapies delivered with lentivirus-based vectors. The company was founded in 1996 by Oxford academics with expertise in viral vectors: gene-delivery vehicles for gene- based medicines. The company underwent IPO on LSE in 2001. Its LentiVector …for delivery of gene-based platform encompasses extensive intellectual property and facilities, which underpin medicines its broad therapeutic candidate pipeline, pre-clinical R&D, and success in providing bioprocessing and process development services for commercial partners. Management recently updated the company strategy. Clinical asset development Focus on bioprocessing and process will be undertaken by partners who in-license OXB’s technology or via spin-outs, development… allowing the company to focus on developing its Lentivector platform