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A Few Tricks up Its Sleeve F Full report Equity Research France 360_CR 360 Report OSE Immunotherapeutics France | Pharma & biotech | MCAP EUR 95.9m 20 February 2017 x Kepler Cheuvreux and the issuer have agreed that Kepler Cheuvreux will produce and disseminate investment research on the said A few tricks up its issuer as a service to the issuer. sleeve Buy (None) What’s it all about? Target price EUR 9.00 OSE Immunotherapeutics is a biotechnology company specialised in Current price EUR 6.71 Up/downside 34.1% immunotherapy for the treatment of autoimmune diseases and cancer. Change in TP none Our analysis suggests positive optionality for the company thanks to its Change in EPS none 2016E none strong and diversified pipeline. Its strategy consists of out-licensing its non-core assets to rapidly monetise them while externalising all clinical Main author development costs to minimise the related opex. The company’s leading Thomas Guillot product, Tedopi (currently in phase III), aims to reach the market in 2020, Equity Research Analyst and we estimate peak sales of half a billion euros for this asset. Our in- [email protected] depth valuation of the company suggests that the street is only including +33 1 70 98 85 27 Tedopi, while the company has three under-the-radar, early-stage assets Pharma & biotech research team with significant potential. Biographies at the end of the report IMPORTANT. Please refer to the last page of this report for keplercheuvreux.com “Important disclosures” and analyst(s) certifications. This research is the product of Kepler Cheuvreux, which is authorised and regulated by the Autorité des Marché Financiers in France. OSE Immunotherapeutics Buy TP EUR 9.00 360 in 1 minute Investment case summary We initiate coverage on OSE Immunotherapeutics with a Buy rating. Tedopi is an asset in late-stage development for the treatment of NSCLC in 2L/3L. We believe that Tedopi is likely to gain value until the phase III results are released in 2018, as momentum is set to increase. Moreover, pending Tedopi’s results, we think the advancement of early-stage assets will also add value to OSE Immunotherapeutics. Key findings of the report We recommend buying OSE Immunotherapeutics, as we believe Tedopi is not fairly valued right now, and early-stage assets are not even included in the company’s value: We agree with the market that most of the company’s value is in the Tedopi asset, which presents a risky profile inherent to all therapeutic vaccines in oncology. However, even with a 33% probability of success, we are convinced that the market is not assigning a fair value to Tedopi. Moreover, we believe that the street does not value the potential of early-stage assets like FR104 (phase I in partnership with J&J) and also overlooks Effi-7 (at pre-clinical stage, in partnership with Servier), which is under the market’s radar screen. Also, the proprietary product Effi-DEM is a first-in-class candidate targeting an innovative pathway, with similar potential to that of the current CKI blockbusters. Although not yet clinically validated, we believe Effi-DEM is likely to boost OSE Immunotherapeutics’ value in the near future. Valuation model Our in-depth valuation is based on the potential of: 1) a cautious positioning of Tedopi in third-line treatment of NSCLC HLA-A2 positive patient population; 2) FR104 solely in RA (while not taking into account other potential indications); and 3) Effi-7 in the treatment of ulcerative colitis. We adopt a discount rate of 15%, in line with our biotech universe. Our valuation stands at EUR9 per share, and we initiate coverage on OSE Immunotherapeutics with a Buy rating. 2 keplercheuvreux.com OSE Immunotherapeutics Buy TP EUR 9.00 Company summary Market data OSE Immunotherapeutics is a biopharmaceutical company specialised in the development of Bloomberg OSE FP immunotherapy dedicated to the treatment of cancer and auto-immune diseases. The company's Reuters OSE.PA main asset is Tedopi, a therapeutic vaccine developed in NSCLC, currently in phase III, with pivotal Market cap (EUR) 95.9m results expected in late 2018. Other clinical-stage assets include FR104 which has been out-licensed Free float (%) 52.0 No. of shares outstanding (m) 14 to J&J as well as Effi-7 in which Servier has an opt-in license option. 3m avg. daily vol (EURm) 0 Management Key shareholders YTD abs. performance -5.2% Dominique Costantini, CEO Emile Loria 30.6% 52-week high (EUR) 8.15 Dominique Constantini 13.0% Alexis Peyroles, COO 52-week low (EUR) 5.70 Maryvonne Hiance, VP, Strategy Guy Chateain 1.9% Strengths Weaknesses One of the fews that has a phase III immunotherapy asset Tedopi is a highly risky development Already monetised non core early-stage assets Early-stage nature of the rest of the pipeline Effi-DEM is a promising candidate Need to sign commercial deal for Tedopi Experienced management Opportunities Threats Tedopi will provide solid value creation if successful Strong competitive environment for Tedopi in NSCLC NSCLC is a large market Phase III failure for Tedopi/Effi-dem Out-licensed candidates bring cash in-flow (FR104/Effi-7) Pricing anticancer therapies Strong balance sheet Key financials (please see the end of this report for full financials) Per share data (EUR) 2015 2016E 2017E 2018E 1 year performance 2011 EPS adj and fully diluted -0.01 0.28 -0.66 -0.70 Cash flow per share -0.41 0.51 -0.78 -0.85 8.5 Book value per share 4.44 3.92 2.92 2.87 DPS 0.00 0.00 0.00 0.00 8.0 Valuation 7.5 P/E adjusted and fully diluted na 23.7 na na P/CF na 13.1 na na 7.0 P/BV 2.2 1.7 2.3 2.3 Dividend yield (%) 0.0% 0.0% 0.0% 0.0% 6.5 FCF yield (%) -4.3% 7.6% -11.7% -12.6% EV/Sales 25.3 3.9 na na 6.0 EV/EBITDA na 19.9 na na EV/EBIT na 19.9 na na 5.5 Feb 16 May 16 Aug 16 Nov 16 Feb 17 Price DJ Stoxx 600 (rebased) Income statement (EURm) Sales 5.1 20.3 0.0 0.0 % Change +chg 300.1% -chg na EBITDA adjusted -3.8 4.0 -11.2 -12.1 EBIT adjusted -3.8 4.0 -11.2 -12.1 Adjusted EBIT margin (%) -74.1% 19.7% na na Net profit reported -0.2 4.0 -9.4 -10.0 Net profit adjusted -0.2 4.0 -9.4 -10.0 Cash flow statement (EURm) CF from operating activities -5.9 7.3 -11.2 -12.1 Capex 0.0 0.0 0.0 0.0 Free cash flow -5.9 7.3 -11.2 -12.1 Balance sheet (EURm) Intangible assets 61.1 45.6 57.5 83.9 Tangible assets 0.1 0.1 0.1 0.1 Fin. & other non-current assets 0.1 0.1 0.1 0.1 Total shareholders' equity 63.4 56.0 41.7 41.0 Pension provisions 0.0 0.0 0.0 0.0 Liabilities and provisions 21.9 19.4 34.3 49.3 Net financial debt -9.0 -16.3 -5.1 7.0 Working capital requirement 8.1 4.0 -1.0 -6.0 Invested capital 8.2 4.1 -0.9 -5.9 Ratios ROE na 6.8% -19.2% -24.3% ROIC na 43.7% -477.6% na EV/IC 15.6 19.6 na na Gearing -14.2% -29.1% -12.2% 17.1% 3 keplercheuvreux.com OSE Immunotherapeutics Buy TP EUR 9.00 Investment case in six charts Chart 1: OSE Immunotherapeutics portfolio Chart 2: Overall survival of phase II with Tedopi Immune activation and regulation 1.0 Survival function Censored 0.8 Tedopi® FR104 0.6 Effi-DEM 0.4 EFFi-7 survival Cumulative Cancer 0.2 Autoimmune Inflammatory diseases 0 Allograft rejection Immunosuppression 200 400 600 800 1,000 Time survived (days) Source: OSE Immunotherapeutics Source: Kepler Cheuvreux Chart 3: Mechanisms of action Effi-DEM Chart 4: Mechanisms of action FR104 Source: Kepler Cheuvreux Source: Kepler Cheuvreux Chart 5: Mechanisms of action Effi-7 Chart 6: SOP (EURm) 160 EUR17m EUR131m 140 120 EUR12m EUR6m EUR97m 100 80 60 40 20 - rNPV Tedopi rNPV FR104 rNPV Effi-7Net cash position Base case Source: Kepler Cheuvreux Source: Kepler Cheuvreux 4 keplercheuvreux.com OSE Immunotherapeutics Buy TP EUR 9.00 Contents Investment case in six charts 4 Investment case summary 7 Paving the way for value creation 7 Cancer immunotherapy: the core focus 7 FR104 and Effi-7: already monetised 8 Initiating coverage with a Buy rating and a TP of EUR9 8 Paving the way for value creation 9 An attractive pipeline emerged from the merger 9 Unity is strength 10 Strategy: quickly provide value creation from non-core assets 11 Cancer immunotherapy: the core focus 12 Tedopi: a multi-epitope cancer vaccine 12 Tedopi target NSCLC: the largest cancer market 14 Promising phase II needs to be confirmed 18 Effi-DEM: the future immune-oncology blockbuster? 26 FR104 and Effi-7: already monetised 34 FR104: a ground-breaking opportunity in autoimmune diseases 34 J&J: a landmark partner for FR104 36 FR104: looking to grab a piece of the large RA market 37 Competitive environment in CD80/CD28 pathway 41 Effi-7: already monetised to Servier, the right strategic option? 43 Deconstructing the forecasts 48 Cancer drug pricing 48 Tedopi: a place in 2L/3L NSCLC 49 FR104 in RA 51 Effi-7: next milestone payment in five years 53 Initiating coverage with a Buy rating 55 Main risks for Tedopi: finding the right partner for EU/US commercialisation 55 Main assumptions of our rNPV for Tedopi 56 rNPV of Tedopi in NSCLC (EUR97m) 57 rNPV of FR104 in RA (EUR12) 58 rNPV of Effi-7 in UC (EUR6m) 60 SOP summary 61 5 keplercheuvreux.com OSE Immunotherapeutics Buy TP EUR 9.00 Appendices 62 Shareholders 62 Key people 62 Immune system functions 63 Use of the immune system to fight diseases: immunotherapy 65 Immunotherapy applied to cancer 66 Immunotherapy applied to autoimmune diseases 71 Research ratings and important disclosures 76 Legal and disclosure information 79 6 keplercheuvreux.com OSE Immunotherapeutics Buy TP EUR 9.00 Investment case summary We initiate coverage on OSE Immunotherapeutics with a Buy rating and a target price of EUR9.
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