Highlights 2017

  • Installed base of close to 650 Idylla™ instruments and commercial cartridge volume 71,000 cartridges

  • Covering over 70 countries worldwide

  • Commercial product revenue + 124% to EUR 12.7m

  • EUR 112.8m year-end cash position

  • Expansion of partnership collaborations with pharmaceutical companies Merck KGaA, Amgen, launch of three new breast cancer partnerships with A*STAR, LifeArc and Genomic Health

  • Launch Companion Diagnostics (CDx) activities, incl. partnership with Amgen signed to register the Idylla™ RAS biomarker tests with the US FDA as a CDx test for Amgen's drug vectibix ©.

  • US commercialization launched

  • 318 employees, 21 nationalities and balanced gender diversity 50% men and 50% women

Founded in 2007, Biocartis provides innovative diagnostic solutions aimed at fast, accurate and globally accessible high precision diagnostics, allowing rapid and effective treatment selection and treatment progress monitoring. This brings clear benefits for the patient, the clinician, the payers, the healthcare industry and society.

Biocartis' proprietary molecular diagnostics (MDx) Idylla™ platform, launched in September 2014, is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting.

Idylla™ addresses the growing demand for personalized medicine. Biocartis is focused on developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology (focus area) and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide.

End of 2017, Biocartis had fourteen oncology tests and two infectious disease tests on the market.

The unravelling of the human genome in the 2000's has led to the discovery of molecular information called biomarkers, which can be detected by molecular diagnostics (MDx), based on patient samples such as blood, urine, sputum, saliva or tissue such as tumor tissue. Having this detailed information paves the way to personalized medicine versus the 'one drug fits all' paradigm we know today, as this can be used to identify the exact type or stage of a disease, and treatment response.

Today, MDx testing is technically complex and often centralized in large, specialised molecular laboratories. Smaller hospitals or laboratories typically send out their samples for analysis by external reference centers. This is time-consuming and requires highly trained personnel. Biocartis believes in rapid and highly accurate diagnostic information near the patient, globally accessible to all, as this potentially can save lives.

High precision diagnostics for high precision medicine in a sustainable healthcare ecosystem

Fast, early and accurate diagnoses are leading the way to appropriate and cost effective care. Biocartis aims to increase its impact by creating better access to personalised molecular diagnostic testing to allow early detection, appropriate treatments and treatment monitoring for all patients.

Biocartis believes that its approach will create long-term positive impact for all stakeholders in the sustainable healthcare ecosystem, including patients, care providers, payers, industry and society as a whole. Biocartis' goal is to improve clinical practice and ultimately, contribute to better patient outcome.

Biocartis share

Average daily value 2017:

10.70

Total traded volume 2017:

19,688,660

Menu of diagnostic tests

Financial summary 2017

Board of Directors

Christian Reinaudo, Chairman

Luc Gijssens

Leo Steenbergen

Ann-Christine Sundell

Executive management

Herman Verrelst, Chief Executive Officer

Ewoud Welten, Chief Financial Officer

Hilde Eylenbosch, Chief Commercial Officer

Benoit Devogelaere, Chief Technology Officer

Harry Glorikian

Hilde Windels

Roald Borré

Peter Piot

Herman Verrelst

Diversified shareholders base

Per May 2018

Infectious disease menu - on market tests:

  • - Idylla™ IFV-RSV Panel (CE-IVD, RUO1 and 510k)

  • - Ebola (EUA)

Sepsis host response partnership with Immunexpress, aimed at development and commercialization of Immunexpress' SeptiCyte™ test for use on Idylla™

Further menu expansion with focus on syndromic panels & bloodstream infections tests that are to be (co-)developed and commercialized through partnerships

Contact

Investor Relations Biocartisir@biocartis.com tel. +32 15 63 17 29

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Disclaimer

Biocartis Group NV published this content on 04 June 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 04 June 2018 12:22:05 UTC