March, 2014 BIOPORTO A/S PRESENTATION

Transcription

1 March, 2014 BIOPORTO A/S PRESENTATION

2 Forward-looking statement 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 Main events of 2013 Financial results in 2013 Revised strategy and future aspirations Recent development and expectations for 2014 Appendix: About BioPorto

4 Focus and stronger foundation for value creation New management team Solid financial strength after share issue and repayment of debt Revised strategy with clear-cut target commercialization of existing product portfolio and acceleration of road to profitability Restructuring of organization to focus on sales Reinitiate dialogue with partners Financial results as expected

5 New management team with strong track-record in commercializing med-tech Peter Mørch Eriksen CEO +15 years experience within medtech/life science in Denmark and abroad. Previously CEO of Sense A/S and VP of Medtronic in both the USA and Denmark. Extensive experience in creating growth, restructuring and funding in technology intensive and complex companies. Chairman of MTIC, member of Lund University Advisory Board, and Director of PMEconsult. Otto Rasmussen CFO Previous Senior Finance Director at Novozymes and has been at Novozymes for a number of years and before that at Novo Nordisk. Mr. Otto Rasmussen holds an MSc in accounting from the University of Southern Denmark, a CPA (certified public accountant) from New Jersey and management training from Harvard. Finn Fjorder EVP SALES +18 years of experience in the med-tech industry in Denmark and abroad, most recently at Pnn Medical and before that at Medtronic. Holds an MSc in chemistry from the Techincal University of Denmark, supplemented by management training from Copenhagen Business School.

6 Sales activity and net result on par with expectations Revenues down 7% as focus has been on establishing new strategy Human diagnostics up 8% Antibodies and tests for R&D down 12% License revenues still modest at DKK 0.6m EBIT of DKK -20m COGS and SG&A increased to DKK 36m from DKK 32m High redundancies and IP-related cost DKK million Net result of DKK -21m Net-financial cost of DKK 2m Tax income of DKK 1m

7 Strong capital base to realize strategy from Fully subscribed share issue (pre-emptive subscription rights) completed in Q3 Issue of 70,724,526 new shares at DKK 1 brings total no. share post issue to 117,874,210 of nom. DKK 1 Net proceeds of DKK 64m used to capitalize company and repay debt - with solid cash resources and no interest bearing debt, BioPorto s capital base is stronger than ever DKKm Long term assets Short term assets Receivables and invent Cash Assets Equity Long term liabilities Short term interest bearing Other Total liabilities Cash flow (operations and investments) Capital is adequate to implement new strategy DKK million

8 BioPorto in the past Too much focus on development Too broad focus on NGAL Test roll-out Too little focus on potential in ELISA and Antibody portfolio Not enough focus on execution

9 The new BioPorto Main elements of new strategy Long term targets Increased sales of entire portfolio via the right sales channels and carefully selected segments and niches Engage in partnerships which will secure the penetration of the NGAL market globally Enhance clinical acceptance of NGAL via Advisory board, new studies and dialog with product users To become cash flow generating and profitable within few years To establish basis for a global roll-out of the NGAL Test

10 Refocusing on niches to accelerate roll-out of NGAL Test Situation Limited knowledge about The NGAL Test on end-user level has delayed roll-out New strategy and initiatives From broad application to focused penetration in transplantation and other critical treatments Strengthen NGAL Test sales force Engage in IP partnerships to accelerate license and OEM potential Initial focus on Europe US roll-out expected in 2016 Data collection for FDA registration commenced.

11 New strategy phased penetration

12 ELISA and antibody portfolio growth potential to be realized going forward Situation Commercial potential of BioPorto s highly specialized and unique ELISA kit and antibody portfolio has not been utilized previously New strategy and initiatives Current sales channels optimized Establishment of own webshop

13 Reorganization and restructuring completed to support sales and cash flow goals New organizational structure implemented and considerable strategic and commercial know-how added to secure a dedicated roll-out of NGAL Test CEO in charge of partnership formation for license and OEM agreements with instrument suppliers New EVP Sales with special focus on The NGAL Test Production and development aligned to support increased sales effort Resources allocated from development to production Streamlining of production and optimization of flow processes to obtain lean structure and high efficiency

14 Ambitious but realizable strategic goals for the future New niche strategy for NGAL Test to increase market acceptance and penetration in Europe Prepare for FDA approval of NGAL Test Grow turnover from ELISA and Antibody portfolio to pave road towards profitability

15 IP situation important steps in establishing a market for NGAL Settlement with Phadia Settlement regarding the revocation of Phadia s patent DK/EP BioPorto receives a worldwide license to Phadia s patents in the NGAL area IP license agreement with Abbott BioPorto and Abbott will cross-license their respective NGAL intellectual property rights. Non-exclusive agreements, which cover all the NGAL related IPR directly and indirectly controlled by both parties Will not directly impact product sales, but resolves claims made by Phadia Important step in collaborating with other players to spread use of the NGAL test - fewer obstacles to license and OEM agreements Agreement include upfront fees and royalties paid on sales for both parties with limited effect on sales. Strategic very important to create a future commercial market for NGAL

16 Ruling on NGAL cutoff patent expected April 1 st 2014 Abbott, Alere, Phadia and Getica has filed an opposition regarding BioPorto s European NGAL cutoff patent. Following the recent agreements, Abbott and Phadia have withdrawn from the case BioPorto has appealed the rejection of the patent and an oral proceeding will take place on April 1 st 2014 If EPO finds that the patent is valid, this could present a competitive advantage to BioPorto going forward, but it would not prevent future protests regarding the patent Should EPO reject the patent, BioPorto s management still believe the company will have a competitive advantage based on its portfolio of other NGAL patents Market access will not be affect by EPO s ruling

17 Formation of European Advisory Board to accelerate roll-out of NGAL Newly set up Advisory Board will convene in May 2014 The Scientific Advisory Board members are: Prof. Dr. med Jean-Louis Vincent, Erasme, Belgium. (Chair) Assoc. Prof. Dr. med Andrew Lewington, St. James s University Hospital, Leeds, UK. (Vice Chair) Director Dr. med Claudio Ronco, San Bortolo Hospital, Vicenza, Italy Prof. Dr. med Laurent Jacob, Saint-Louis Hospital, Paris, France Prof. Dr. med Michael Haase, Otto-von.Guericke University, Magdeburg, Germany Dr. med, PhD, Hilde RH DE Geus, Eramus University Medical Center Rotterdam, NL

18 Strategic initiatives expected to materialize in turnover growth and improved net result from 2014 Turnover expected to increase 15-40% to DKK 19-23m Higher sales of ELISA kits and antibodies Modest increase in sales of The NGAL Test to transplant centres Net result improvement of DKK 6-10m to a loss of DKK 10-14m Higher sales Optimized cost position and fewer on-offs Management focus for 2014 Successful deployment of sales strategy Establishment of Advisory Board to support The NGAL Test roll-out Utilize potential in ELISA and antibody portfolio to increase sales Prepare FDA approval process Secure lean processes and resource allocation throughout organization Continued cost control

19 An new era for BioPorto has commenced Strong portfolio of niche products and IP New management team with proven trackrecord in strategy, execution and commercialization of med-tech Refocused strategy to accelerate penetration of NGAL Test and realize growth potential in ELISA and antibody portfolio Restructuring of organisation and solid cash position to support strategy Profitable & cash flow generating in few years

20 Financial calendar 2014 Q May 6, 2014 Q August 8, 2014 Q November 7, 2014 Q&A

21 APPENDIX: ABOUT BIOPORTO

22 About BioPorto Founded in 2000 About 25 employees in sales, marketing, production, development and administration BioPorto markets a range of diagnostic tests and antibodies The focus product is NGAL, a biomarker for the diagnosis of acute kidney injury Listed in 2004 (symbol: BIOPOR) Market capital: DKK 450 million

23 Product overview

24 AKI diagnosis NGAL vs. serum creatinin Bennett et al. Clin J Am Soc Nephrology 2008

25 NGAL improving AKI diagnostics

26 More studies are needed

27 IP rights for NGAL

28 Registration of The NGAL Test