BioPorto. Annual General Meeting

Transcription

1 BioPorto Annual General Meeting April 14, 2016

2 Forward looking statements This presentation contains forward-looking statements. Words such as believe, expect, may, plan, strategy, estimate, target and plan and similar expressions identify such forward-looking statements. Statements other than historical facts included in this presentation concerning our plans, objectives, goals, future events and performance are forward looking statements. They involve risks, uncertainties and other factors, which may cause actual results, performance and achievements to differ materially from the results discussed in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date of this presentation.

3 Agenda 1. Report of the Company s activities during the past year 2. Presentation of the annual report for approval and allocation of profit or covering of loss 3. Decision to discharge the Board of Directors and Executive Management from liability 4. Approval of remuneration of the Board of Directors 5. Election of members to the Board of Directors 6. Proposals from the Board of Directors A. Change from bearer shares to registered shares B. Proposal for amending clause 10 in the Company s Articles of Association Electronic communication with the Company s shareholders C. Proposal for amending clause 18 in the Company s Articles of Association renewal of authorization to issue of warrants 7. Election of Auditor 8. Any other business

4 Thomas Magnussen Chairman s Report

5 Chairman s Report 2013: New Board and Management analyzing situation Reasons for years of disappointing results How to turn a downwards trend How to balance expectations compared to the Company s real situation 2014: Adjusting the course, restructuring, defining new strategy Re-establishment of broken international relationships: Abbott, Siemens Focus on USA with The NGAL Test TM Clinical trials with leading US hospitals initiated for The NGAL Test TM ELISA kits and Antibody Shop reinvigorated 2015: Strategy perfectly executed by Management, milestones made: Clinical trials for The NGAL Test TM in USA successfully completed Routine users of The NGAL Test TM significantly increased ELISA Kits and AntibodyShop enforced and business improved Application for FDA approval and registration of The NGAL Test TM in USA Initiation of new aggressive growth strategy in USA based on successful clinic trials Share issue to finance the new strategy Continued streamlining of operations, cost reductions, growth

6 Results: EBIT and LTM revenues (DKKm) EBIT Revenues

7 Chairman s Report 2015: Substantial adjustment of strategy Focus on future growth potential rather than short term financials Aggressive growth plan in USA initiated Offices in Chicago (444 Michigan Avenue), significant employments Despite major investments, EBIT signifcantly improved 2016: Strong platform for massive growth Distribution agreement with Siemens; financial effect late 2016 FDA approval expected any time Launch of The NGAL Test TM in USA; significant financial effect expected from Q3 Continued improvement in The NGAL Test TM sales outside USA Continued enforcement of R&D strategy developin g solutions rather than selling wholesale New solution platforms to be introduced late 2016, financial effect from 2017 Revenue growth 2016: 30-50% expected (NGAL in USA, AntibodyShop) 2017: Growth rates expected to continue (NGAL, New Solutions)

8 Chairman s Report Warrant program implemented For Management and certain employees Ensuring momentum, continuity, focus on execution of growth strategy Board issues Remuneration to be unchanged for the four non-executive directors Roar Seeger decided to resign from the Board for personal reasons New candidate for the Board: Niels Christian Nielsen

9 Chairman s Report THANK YOU! To Shareholders for your trust and support To Management for outstanding execution of the strategy To Employees for exceptional efforts To my fellow Board members for pleasant cooperation

10 Peter Mørch Eriksen, CEO Results and Strategy

11 Preparing for growth via focused execution of strategic targets

12 Financial highlights

13 Revenue growth in line with latest expectations Revenue in Q up 18% YoY solid performance across products except for antibodies, which fell short of expectations 2015 revenue is up 9% to DKK 20.4m (2014: DKK 18.7m) Quarterly revenue (DKKm) Revenue (DKKm, LTM)

14 Growth primarily attributable to pick-up in The NGAL Test TM and in ELISA kits Revenue from the NGAL Test TM up due to penetration in South Korea and US (research) sales no progress in European performance Revenue by product (DKKm) 20 new routine users added to portfolio in 2015 Total NGAL portfolio up 35% The NGAL Test TM up 56% Antibodies on par with last year

15 EBIT loss reduced despite higher cost to clinical studies and US organization establishment EBIT improvement from DKK -15.3m last year to DKK -12.8m in 2015 Net result from DKK -12.9m last year to DKK -10.7m in 2015 EBIT (DKKm) R&D expenditure high in 2015 due to US clinical studies of The NGAL Test TM SG&A cost reduced due to higher efficiency, cost control and fewer employees EBIT (DKKm, LTM) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q

16 Strong balance sheet supports growth strategy Fully subscribed share issue of 11,724,750 share in August 2015 with net proceeds of DKK 26.5m Cash burn from operating activities of DKK 16.6m in 2015 DKK 34.9m in cash at hand as of December adequate to support BioPorto s organic growth strategy DKKm Long term assets Short term assets Receivables and invent Cash Assets Equity Long term liabilities Short term interest bearing Other Total liabilities

17 FDA approval of The NGAL Test TM pending Questions from FDA received late December 2015 The response primarily involved additional trials and the processing of the comprehensive statistical material from the clinical study Approval is expected in time for US launch, which is planned no later than Q Mar Sept Oct Dec Mar Q Conclusion of accelerated clinical trials with 250 patients Submission of initial registration application Application changed to De Novo classification Questions from FDA received Answers submitted to FDA Launch (expected)

18 Accelerated roll-out in US will initially be focused on selected clinics and hospitals to gain traction US subsidiary established January, 2016 Jim Casey (VP, sales) and Lisa Anselmino (Senior Director, business development) will be fronting office with 5-7 employees. Peter Eriksen will be CEO and spend part of his time in US Current focus on reimbursement and settling pricing structure US accelerated growth strategy 2016 Await FDA approval Current research users (ROU) as lifting stone for regular clinical usage Focused sales effort towards selected group of clinics and hospitals Establishment of US advisory board to provide further academic support for NGAL as marker for AKI Development of organization TARGET: TO IMPLEMENT THE NGAL TEST TM ON 20 HOSPITALS AND CLINICS BY END 2016 US accelerated growth strategy 2017 Widen sales effort geographically Seek distribution agreements to support own efforts Further development of organization TARGET: TO DOUBLE NUMBER OF HOSPITALS AND CLINICS IN US USING THE NGAL TEST TM

19 Very strong uptake of The NGAL Test TM in South Korea BioPorto undisputed market leader In the first half of 2015, The NGAL Test TM was approved for diagnostic use in South Korea At this point, the market had already been presented to NGAL through a competitor and several hospitals were running NGAL tests BioPorto quickly reacted on the opportunity and increased sales efforts towards hospitals, which resulted 10 new routine users in 2015 Tests have been setup and calibrated to equipment in 2015, and is now ready for use Interest and growth momentum is still strong

20 White paper publication important to support strategic dialogue White paper publication in The Journal of Thoracic and Cardiovascular Surgery will be used to escalate communication and marketing efforts especially towards public institutions The National Institute for Health and Care Excellence (NICE) in the UK are currently evaluating NGAL Long decision processes and different incentive structures in European healthcare means that a European penetration of NGAL and uptake in sales will most likely await US penetration but the white paper is already helping The article in TJTCS equips clinical staff at cardiac intensive care units with a decision algorithm for the practical application of NGAL. BioPorto expects the article will give weight in the decisionmaking processes leading to inclusion of NGAL tests in official clinical guidelines, which are often determined at a national level.

21 Distribution agreement with Siemens Healthcare marks a significant strategic milestone for BioPorto In January 2016, BioPorto signed a distribution agreement with Siemens Healthcare regarding deliverance of a NGAL test adapted for Siemens Healthcare s BN II and BN ProSpec Systems The agreement is exclusive with regard to those instruments and has a worldwide scope Commercial sales will commence after completion of adaption of the test to the instruments expectedly in 2H 2016 The agreement will enhance the availability of NGAL tests and increase the awareness of NGAL as a diagnostic marker

22 New products under development expected launch late 2016 Unique technology, knowledge and portfolio of monoclonal antibodies will be applied to develop new markers going forward Special attention currently on: In the area of the innate immune system, BioPorto is developing new ELISA kits to complement the company s unique MBL assay Theraputic Drug Monotoring (TDM) development activities focus on antibodies of different active ingredients in drugs, as no practical methods are currently available for this purpose.

23 New organization in place as of January 2016 CEO, DK + USA Peter M. Eriksen CFO Jakob B. Christensen Sr. Dr. Business Dev. Lisa Anselmino VP Sales, USA Jim Casey COO, DK Michael Pålsson Sales/ Tech support Sales/ Marketing RD/ Production/QA + RA

24 Management agenda in 2016 focused on successful launch in US and on Primary targets FDA approval of The NGAL Test TM Roll-out of The NGAL Test TM in US from Q and implementation on 20 hospitals by end-2016 Continued growth of The NGAL Test TM in South Korea and modest growth in Europe Double number of US hospitals using The NGAL Test TM in 2017 Further expansion of application space for NGAL NGAL sales via license and OEM agreements Secondary targets Launch of new ELISA kits within immune deficiency Expansion of antibody portfolio Negotiations of license and OEM agreement Continued expansion of antibody and ELISA portfolio Addition of new products and technologies Negotiations of license and OEM agreement Growth 30-50% growth in turnover Maintain high growth rates

25 US introduction of The NGAL Test TM will drive growth in 2016 Turnover expected in DKK 27-30m range (growth of 30-50%) Growth from introduction of The NGAL Test TM in US is main growth driver Full-year effect of increased sales to South Korea Siemens agreement will contribute to turnover in 2H 2016 Moderate increase in sales of ELISA and antibodies Turnover will be back-end loaded EBIT loss of DKK 11-13m Adjusted April 8, 2016 as a result of the warrant program from an EBIT loss of DKK 7-9m. The warrant program has no effect on cash resources. New, aggressive US growth strategy requires allocation of added resources Continued development to secure long-term product offering

26 BioPorto ready for strong growth The NGAL Test TM ready for US roll-out in 2016 Positive trends in our existing business to be intensified ELISA and antibody portfolio to be strenghtened Focus in implementing a growth case from 2016

27 BioPorto A/S Tuborg Havnevej 15, st. DK-2900 Hellerup Denmark Phone (+45) Web Financial calendar 2016 April 14 Annual General Meeting May 4 Interim report, Q August 4 Interim report, Q November 3 Interim report, Q3 2016