Nordic Biotech & Pharma. 27. November 2018

Transcription

1 Nordic Biotech & Pharma 27. November

2 Certain information set forth and given in this presentation contains forward-looking information, including future oriented financial information and financial outlook, under applicable securities laws (collectively referred to herein as forward-looking statements). Except for statements of historical fact, information contained herein constitutes forwardlooking statements and includes, but is not limited to, the (i) projected financial performance of ViroGates A/S (ViroGates); (ii) the expected development of ViroGates business, projects and joint ventures; (iii) execution of ViroGates vision and growth strategy, including with respect to future M&A activity and global growth; (iv) sources and availability of third-party financing for ViroGates projects; (v) completion of ViroGates projects that are currently underway, in development or otherwise under consideration; (vi) renewal of ViroGates current customer, supplier and other material agreements; and (vii) future liquidity, working capital, and capital requirements. Forward-looking statements are provided to allow potential investors the opportunity to understand management s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Although forward-looking statements contained in this presentation are based upon what management of ViroGates believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. ViroGates undertakes no obligation to update forward-looking statements if circumstances or management s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. 11/23/2018 2

3 Slide Topic 4-8 Recent listing, Q Report and Business Description and Aspiration 9-10 Market opportunity Health Economic savings potential 13 Commercial strategy & execution 14 Product offering 15 The team Management and Board 16 Use of proceeds Appendices 3

4 Listed on NASDAQ First North CPH On 26/ Ticker VIRO (ISIN: DK ). Gross proceeds raised 75 million DKK 11/23/2018 4

5 First 9 months revenues amounted to million DKK (2.042 million DKK) (22% up) Operating loss of million DKK ( million DKK) IPO cost 5.2 million DKK Total Cash flow was million DKK ( million DKK) Cash flow from financing activites million DKK (0) Cash flow from operating activites ( million DKK) Total Equity september 30th was million DKK (4.426 million DKK) Net Cash of million DKK (2.350 million DKK) 18 hospitals in 5 countries were testing suparnostic One hospital (9 th City Clinical Hospital Minsk, Belarus) converted to paying customer suparnostic TurbiLatex CE-IVD cleared and launched for Roche cobas c111 Subgroup analysis of Interventional study TRIAGE III showed statistically significantly shorter length of stay for supar patients compared to control group VA1 Post Q3 Report news Observational study showing that suparnostic improved risk prediction of both high- and low risk acute medical patients triaged by the National Early Warning Score 11/23/2018 5

6 Slide nummer 5 VA1 MB hvad er forskellen til total relateret til?? ViroGates AS;

7 ViroGates brief: Helps Acute Medical physicians to safely discharge patients Proprietary biomarker testing branded suparnostic More than 500 peer reviewed publications support clinical claims CE-IVD marked products and clinical customers 6

8 2 out of 3 acute care patients admitted to the ward may be avoidable 1 suparnostic test monitors activation of the immune system Patients with low supar levels are low risk = no urgent need for care Current physiological scores are time-consuming and complicated supar provides instant & objective information for easy stratification of patients supar adds information to current physiological scores 1: Data from TRIAGE 1 study - North Zealand Hospital (Unpublished) 7

9 Low supar equals low risk patients (<1% of dying in 30 days) Low risk patients can be sent home or scheduled for elective treatment Outcome is optimised use of resources and financial savings 1: Data from TRIAGE 1 study - North Zealand Hospital (Unpublished) 8

10 Million Euro Acute care Post acute care* Europe RoW NA Assumptions: End user unit price: AC: Europe, NA 20 and RoW (SA, RF, J, CH) 10-1 test per patient PAC: Europe, US and RoW 10-3 tests per patient SNF, IRF, LTACH - EU and ROW extrapolated based on population hospitals in the US hospitals in EU of which provide Acute Care *US 2.9 mill patients - cs/default-source/databook/june-2016-data-bookhealth-care-spending-andthe-medicare-program.pdf, HHOPE Hospitals in Europe Healthcare Data 2012 p.14 9

11 GP Physicians Private Health test 19 billion Euro market opportunity Health screens and regular visits at the GP offices 27 Billion Euro market opportunity Private Health tests are conducted at independent labs/pharmacies and with specialist doctors/health clinics Based on clinical chemistry and immunology tests conducted today - Frost & Sullivan Analysis of the US clinical laboratories Market

12 Cost of using suparnostic (Euro million) Net Health care savings (Euro million) Source: Average cost per hospital-day based on Statista, Incentive, Eurostat Savings based on data from Triage III study (unpublished) and Incentive Health care consultants calculations 11

13 Cost of using suparnostic (Euro million) Net Health care savings (Euro million) Source: Average cost per hospital-day based on Statista, Incentive, Eurostat Savings based on data from Triage III study (unpublished) and Incentive Health care consultants calculations 12

14 Go to market strategy will be defined by: Markets with high proportion of private players Markets with high adoption of new biomarkers Markets with shortness of emergency department experienced staff Rollout in the EU

15 Application R&D use & clinical lab Near patient use Automated, centralized laboratory Detection platform Immuno-detection technology ELISA Lateral flow Turbidimetric Year of market introduction 2009 (CE-IVD marked) 2015 (CE-IVD marked) 2018 (CE-IVD marked) 14

16 The Management team Jakob Knudsen (CEO) LL.M & MBA 15+ years operational experience in life science, CEO ViroGates A/S since 2011 CCO and CFO (Egalet Inc. Nasdaq EGLT) , Sales and Marketing and head of Business development (ALK-Abelló Nasdaq ALK-B) May Britt Dyvelkov (CFO) 20+ years experience in finance, CFO ViroGates A/S since 2008, CFO (Kerfi ), CFO (EET Nordic ) Dr. Jesper Eugen-Olsen PhD, CSO Co-founder +30 years of research experience and author of +100 peer rev. scientific publications, Head of Research dept. Hvidovre Hospital Non-Exec. Board Dr. Lars Kongsbak (Chairman) 25+ years operational experience in life science incl. diagnostics Bernd Uder 25+ years operational experience in life science incl. diagnostics Dr. Jørgen Thorball 25+ years experience in life science incl. diagnostics & in building companies Lars Krogsgaard 25+ years experience in building global companies Dr. Thomas Krarup PhD, VP Sales & Marketing +25 years of commercial experience in diagnostics from Radiometer Medical, Becton Dickinson, Roche 15

17 Status & outlook Use of proceeds (m ) Adequate product offering in place Clinical validation in place Health economics in place Ready for commercial execution ,4 Product development Clinical documentation IP The investment will secure cash flow positive business Commercial execution 16

18 Slide Topic 19 The suparnostic test is based on a simple blood draw 20 Strong patent estate 21 Abbreviations Emergency departments are facing increased pressure from patients seeking care. supar is in my view a promising tool to stratify the risk in all the medical patients. supar may well emerge as a suitable tool for doctors to cope with the overcrowding issues PROF. FRANK TACKE MD University Hospital Aachen Dept. of Medicine III Prof. 17

19 The upar protein is located on the surface of white blood cells Upon immune activation, upar is released into the blood stream as soluble-upar Increased supar level is indicative of disease progression and mortality Clinical data on supar have been reported in +700 peer reviewed articles supar level is not related to specific disease and not affected by circadian changes, short-term life circumstances (e.g. fasting) and common ailments (e.g. influenza) supar is readily detected using standard immuno-assay technology Works near patient setting 20 minutes testing time makes it ideal for quick triaging 18

20 Patent family ID Main claim Expiry WO2001/ HIV prognostication 2020 WO2002/ Prognostication based on various bacterial pathogens 2022 WO2008/ Prognostication of LGI/CVD type 2 diabetes 2028 Filing Febr UK supar in the Emergency Dept Several divisionals have been filed In addition, 6 patent families have been in-licensed. Royalty and milestones are capped at 95 teuro The essence of the above mentioned patent families, is that Virogates A/S holds the exclusive rights and freedom to operate to use supar in diagnostics and as prognostic biomarker. 19

21 Abbreviations: AC: Acute care = emergency department ED: Emergency department PAC: Post acute care supar: Soluble urokinase plasminogen activator receptor ELISA: Enzyme-Linked Immunosorbent Assay KOL: Key Opinion Leaders NA: North America RoW: Rest of world CE marked: CE marking is a mandatory conformity marking for certain products sold within EFTA & The European Union (according to the EU CE In-vitro diagnostics directive) 20