A good diagnosis is half the cure

Transcription

1 Investor Dagen Dansk Aktionærforening BioPorto A/S, June 13, 2017 A good diagnosis is half the cure

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 forwardlooking 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 BioPorto - Insight Scandinavian based company Increased global presence in 2016 Company founded in 2000 Listed on Nasdaq, Copenhagen in 2004 Market cap ~ DKK 292 million Based in Copenhagen with subsidiary in USA Strong IP portfolio and licensing agreements Subsidiary Chicago, US Headquarter Copenhagen Product portfolio based on core competences within antibodies: Monoclonal antibodies ELISA Kits IVD diagnostic solutions

4 Why is the introduction of a new AKI biomarker important? Introduction of new biomarker No new Biomarker introduced Faster re-acting biomarker Early diagnosis 2 hours Risk prediction / stratification Routine use of a new Biomarker High risk of AKI Fewer AKI patient cases & & increased ICU stay Reduced healthcare costs Reduced number of dialysis patients Improved individual patient management Decreased ICU stay

5 Designed for use on Hospital machines Reducing costs Measurement in plasma and urine Better treatment of patients High precision Early diagnosis

6 Introducing NGAL: Improves diagnosis of Acute Kidney Injury Stage of renal degeneration from normal to end stage Complications Normal Increased risk Damage Reduced kidney function Kidney failure Death NGAL INTERVENTION Serum Creatinine From 2 hours hours

7 Product segment: The NGAL Test IVD biomarker Diagnostic need Business potential Early diagnosis of Acute Kidney Injury (AKI) +13 million patients each year* Up to 4 million related deaths High co-morbidity raises health costs Address Acute Kidney Injury (AKI) while preventable Set-up personalized medical management AKI in % of all people admitted to hospital and The NGAL Test will be used 4-5 times per patient during a stay** Expected price of approx. USD 20 per test. Hospital stays (2012) USA 36,5 mill., average lenght 4,5 days*** EU 85 mill., average lenght 8 days**** Asia 24 mil. Focus Segments Cardio- Pulmonary Bypass (CPB) ICU * Source: ** National Institute for health and Care Excellence (NICE) *** Agency for Healthcare Research and Quality (USA) **** Eurostat Kidney Transplantation

8 Product segment: Monoclonal Antibodies and ELISA Kits Key customer segments Key disease areas / antibody Hospitals & Clinics Pharmaceutical & Biotech companies CRO s Nephrotoxicity NGAL Allergy IgE Infectious Diseases Influenza PID / Autoimmune diseases MBL / Complement Component Diabetes / Obesity GLP-1 Research institutions Veterinary industry Assay developers & ELISA manufacturers

9 Using our impressive knowledge of antibodies to create new, unique IVD solutions Unique antibodies of high continuous quality ELISA Kits Clinical Chemistry Lateral Flow ROU RESEARCH DISCOVER Basic Research Clinical Research Assay development New monoclonal antibodies / ELISA Kits New IVD solutions ROU / IVD DIAGNOSE In Vitro Diagnostic ACT Clinical Research Continuous in-house development Market feed-back

10 grad - generic Rapid Assay Device sample pad test line control line biotinbinding protein anti-mouse / rabbit / goat antibodies Quantifiable and ready to use results in 10 minutes grad product benefits Multiple applications environmental/agriculture, food industry, veterinarian diagnostics and human disease diagnostics. Customization use own or BioPorto s antibodies antibodies are mixed prior to being added to the strip In-house development of rapid assays in only 2 days BioPorto offers contract development of 3rd party assays

11 FDA process successfully initiated as scheduled in beginning of 2017 Protocol for clinical trials finalized in January 2017 after discussion with FDA Sites for clinical trials selected in February and March - 20 of the leading AKI hospitals and clinics in the US A total of 530 patients will participate - enrolment of first patient in April 2017 Total external cost of concluding the FDA registration approval process expected to be DKK 17-18m in 2017 and 2018

12 Process for FDA approval of The NGAL Test TM Nov Jan Q Financing Finalize design of protocol after feedback from FDA Clinical trials to commence Questions from FDA Q2- Q Submission of application Q Clinical studies finalized End Answers to FDA Approval expected Q2- Q Mid- 2018

13 Highlights Q Strong NGAL sales growth 42 % Strong overall revenue growth 11 % Siemens launch of NGAL in Q2 Increased costs in connection with FDA-application FDA-process on schedule Cash position 29.2 million as of March 31, 2017

14 Revenue growth of 11% driven by strong NGAL performance Revenue in Q of DKK 5.7m (2016: DKK 5.2m), corresponding to overall healthy growth of 11% Revenue is once again trending positive, as sales organization has been restructured and focus strengthened Quarterly revenue (DKKm) Revenue (DKKm, LTM) Q1 Q2 Q3 Q4 16 Q Q Q Q Q Q Q Q Q1 2017

15 Momentum and interest in US for NGAL is increasing rapidly YoY growth of 173% in Research Use Only sales to US clients Results from pre-approval US market entry strategy is starting to materialize Strongly increasing interest in and acceptance of NGAL as a biomarker Both repeat sales and new uses 12 US hospitals and clinics as regular users as of March ROW revenue increase of 20%, primarily driven by launch of distribution agreement with Siemens Healthcare

16 Revenues from ELISA kits and antibodies also increasing in Q On top of strong performance in Q1 2016, antibody sales rose 6% in Q to DKK 3.1m Focus on large scale sales to assay developers is paying off bulk orders are rising Sales of ELISA kits up healthy 12% driven by MBL kits and ELISA animal kits

17 High activity related to FDA process increase operating loss in Q EBIT in Q at DKK -9.3m against DKK -5.4m last year Quarterly EBIT (DKKm) High level of activities associated with FDA approval process increase loss Restructuring program still under implementation will reduce capacity cost DKK 3m in 2017 and DKK 4m in 2018 compared to Warrant program introduces in Q effects operating loss negative by DKK 0.6m in Q Q1-9.3 Q2 Q3 Q4

18 RUO in the US and increased sales via Siemens distribution agreement will drive sales growth in 2017 Turnover expected in DKK 25-28m range (growth of 20-35%) Growth primarily driven by higher sales of The NGAL Test (RUO in US, Siemens and own sales in Europe/Asia) ELISA kits and antibodies also expected to grow sales EBIT loss of DKK 26-29m Capacity cost to increase due to clinical trials in US and other approval related items (DKK 10m in total in 2017) Restructuring in 2H 2016 will reduce cost by DKK 3m in 2017

19 On track for FY2017 guidance - focus on sustaining strategic momentum and sales in and on Primary targets Completion of protocol for FDA study in Q1 Initiate enrolment of patients for clinical trials for The NGAL Test in Q2 Increase number of users of NGAL in Europe and Asia Submit FDA registration of The NGAL Test in Q2 Registration approval mid-2018 Increase number of distribution agreements for NGAL Increase number or RUO of NGAL in US Launch new NGAL and innate immune defense products Secondary targets Increase sales of ELISA kits Expand portfolio of antibodies New license and OEM agreements Continued expansion of antibody and ELISA portfolio New license and OEM agreements Growth 20-35% Maintain high growth rates