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Curetis 2018

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  1. [verwijderd] 30 april 2018 07:45
    ABM FN-Dow Jones) Curetis heeft in 2017 het verlies zien oplopen, bij een vrijwel vlakke omzet. Dit bleek maandag uit de jaarcijfers van het Duitse diagnosticabedrijf met een notering aan Euronext Amsterdam.

    De omzet daalde op jaarbasis van 1,3 miljoen naar 1,2 miljoen euro en het nettoverlies liep op van 15,2 miljoen naar 19,3 miljoen euro.

    De uitgaven liepen op van 16,7 miljoen naar 20,1 miljoen euro en de zogenoemde cash burn uit operationele activiteiten bedroeg 15,7 miljoen euro, exact gelijk aan de cash burn in 2016. De cash burn uit investeringen bedroeg afgelopen jaar 0,4 miljoen euro, hetgeen beduidend minder was dan de 7,4 miljoen euro in 2016. In 2016 nam Curetis evenwel de GEAR-database van Gyronimo over.

    Eind 2017 beschikte Curetis over een kaspositie van 16,3 miljoen euro, tegenover 22,8 miljoen euro eind 2016. Afgelopen vrijdag meldde het diagnosticabedrijf echter dat het 4,1 miljoen euro zal ophalen met de uitgifte van nieuwe aandelen. Bovendien heeft Curetis toegang gekregen tot een een extra faciliteit ter waarde van 10 miljoen dollar van Global Corporate Finance.

    In een toelichting zei CEO Oliver Schacht dat de ontvangen toestemming van de Amerikaanse toezichthouder FDA voor het vermarkten van het Unyvero systeem en bijhorende LRT applicatie cartridges in de Verenigde Staten "een enorme mijlpaal" voor Curetis is. Het diagnosticabedrijf mikt op een commerciële lancering in het lopende tweede kwartaal.

    Ondermeer dankzij de lancering in Amerika en met behulp van distributiepartners denkt Curetis het aantal geplaatste Unyvero-systemen "significant" te laten stijgen in 2018, van 175 aan begin van het jaar naar 250 tot 300 aan het einde van dit jaar.
  2. [verwijderd] 30 april 2018 07:55
    Opnieuw bedroevend slechte cijfers zoals verwacht.
    Vlakke omzet en stelt niets voor.
    Enorme uitgaven 20,1 miljoen euro t.o.v omzet.
    Cash + 4,1 miljoen betekent in 2019 reeds de 8 miljoen euro aanspreken + opnieuw vers kapitaal (hoeveel aandelen erbij ?).
    Outlook 2018.... 175 UA's naar 250 tot 300, opnieuw teleurstellend, meestal wordt slechts de ondergrens bereikt.
  3. dader 30 april 2018 08:03
    quote:

    De_bonte_leeuw schreef op 30 april 2018 07:55:

    Opnieuw bedroevend slechte cijfers zoals verwacht.
    Vlakke omzet en stelt niets voor.
    Enorme uitgaven 20,1 miljoen euro t.o.v omzet.
    Cash + 4,1 miljoen betekent in 2019 reeds de 8 miljoen euro aanspreken + opnieuw vers kapitaal (hoeveel aandelen erbij ?).
    Outlook 2018.... 175 UA's naar 250 tot 300, opnieuw teleurstellend, meestal wordt slechts de ondergrens bereikt.
    Alles bij elkaar wat is dan de openindgskoers vandaag???
  4. dader 30 april 2018 08:09
    Bij goeie cijfer gemiddeld +15% en bij slecht cijfers -15% is de trend dit kwartaal .
    TO staat op 5.70 ziet er zeer slecht uit.
  5. forum rang 10 DeZwarteRidder 30 april 2018 08:15
    On December 31, 2017, Curetis Group’s cash, cash equivalents and financial assets amounted to EUR 16.3 million (including the proceeds from an EIB loan facility drawn-down in April 2017 of EUR 10 million) compared with EUR 22.8 million as of December 31, 2016.
    The financial statements 2017 have been prepared on a going concern basis despite the fact that as of December 31, 2017, remaining cash reserves were insufficient to cover at least 12 months after the signing date of the auditor’s report. This determination was based on work conducted by the auditors PwC including detailed scenario analysis and risk assessments, incl. assessment of all strategic and tactical financing options with several additional cash inflows based on potential debt or equity financings and various cost reduction and cash preserving measures identified for implementation during 2018. Please also refer to Note 3.27 on ‘Going Concern’ of the Group’s audited 2017 consolidated financial statements.
  6. [verwijderd] 30 april 2018 08:38
    kom op, er wordt enkel naar financials gekeken hier, terwijl daar weinig verrassingen zijn... dat wisten we toch al; ik let liever nu op de outlook.

    www.curetis.com/uploads/tx_news/20180...

    Operational Highlights 2017 up to and including April 2018
    ? De Novo request for Curetis’ Unyvero System and Unyvero LRT Application granted by
    U.S. FDA on April 3, 2018;
    ? Completed build-out of commercial team and initiated commercial roll-out of Unyvero
    LRT Application in the U.S.;
    ? Launched novel CE-IVD marked Unyvero Application Cartridges for Intra-Abdominal
    Infections (Unyvero IAI) and, most recently, Urinary Tract Infection (Unyvero UTI);
    ? Established U.S. Scientific Advisory Board to provide scientific counsel on advancing the
    development of pipeline programs for the U.S. market;
    ? Raised additional capital of EUR 4.1 million via private share placements and with
    access to additional USD 10 million in equity over 36 months;
    ? Received approval from the Singapore Health Science Authority for the Unyvero HPN
    and BCU Application Cartridges;
    ? Signed strategic agreement in form of a memorandum of understanding with MGI (a BGI
    Group company, China) to leverage Curetis’ sample preparation technology and to
    enable short-term commercialization of NGS-based molecular microbiology;
    ? Awarded grant funding commitment from Austrian Research Promotion Agency (FFG) for
    Ares Genetics’ project ‘The Digital Microbe’ with total project volume of EUR 1.6 million;
    ? Increased global installed base of Unyvero Analyzers by 33 to 175 by year-end of 2017,
    a 23% growth rate from 142 Analyzers at the end of 2016.
    1 With completion of a
    pharmaceutical partners’ clinical trial, the Company has in Q1-2018 bought back
    Unyvero Systems deployed in this clinical trial and has continuously taken a stronger
    focus on higher priority accounts and conversion efficiency, which led to a re-deployment
    of Unyvero Systems resulting in a temporary decrease to 167 Analyzers by the end of
    the first quarter 2018;
    ? Initiated second U.S. FDA study to obtain clearance for the Unyvero IJI Invasive Joint
    Infections Application Cartridge;

  7. [verwijderd] 30 april 2018 08:39
    Partnered with Biotest to support academic PEPPER Pentaglobin® Peritonitis trial with
    Unyvero IAI Application Cartridge;
    ? Strengthened Supervisory Board with the appointment of Dr. Nils Clausnitzer, MD, MBA,
    elected at the 2017 AGM;
    ? Founded wholly-owned subsidiary Ares Genetics in Vienna, Austria, to advance the
    business building on the GEAR database asset acquired form Siemens in September
    2016.
    2017 Key Financials
    ? Revenues: EUR 1.2 million (EUR 1.3 million in 2016).
    1
    ? Expenses: EUR 20.1 million total cost of sales, distribution costs, administrative
    expenses and research & development expenses (EUR 16.7 million in 2016).
    ? Operating loss: EUR -18.6 million in 2017 due to the costs of the commercial expansion,
    R&D and pipeline expansion efforts (EUR -15.2 million in 2016).
    ? Net loss: EUR -19.3 million (EUR -15.2 million in 2016).
    ? Cash & cash equivalents: EUR 16.3 million as of December 31, 2017 (EUR 22.8 million
    as of December 31, 2016).
    1
    ? Net cash burn from operating activities: EUR -15.7 million in 2017 (EUR -15.7 million in
    2016).
    ? Net cash burn from investing activities: EUR -0.4 million in 2017 (EUR -7.4 million in
    2016), mainly resulting from the acquisitions of the GEAR database and Gyronimo
    platform in 2016.

    Commenting on Curetis’ 2017 results, Curetis´ CEO Oliver Schacht, stated: “In 2017, we
    believe we have paved the way for accelerated future growth and expansion of Curetis’
    capabilities. This includes the completion of our integration of the GEAR and Gyronimo (now
    ARESdb and Unyvero A30 RQ, respectively) asset acquisitions to build a truly versatile ‘anyplex’
    platform, which covers a broad range of infectious disease diagnostics. Moreover, we
    have focused on the clearance of our Unyvero Platform and Unyvero LRT Cartridge in the
    U.S. and invested in qualified and experienced personnel to initiate the commercial U.S. rollout
    of these products immediately following their clearance. The recent U.S. FDA clearance
    marks a major milestone in expanding our global commercial footprint into one of the largest
    and most important diagnostics markets worldwide. We are confident in our U.S. roll-out
    strategy and remain dedicated to achieving a number of additional milestones throughout the
    year.”
  8. [verwijderd] 30 april 2018 08:40
    Anticipated Milestones and 2018 Guidance
    Commercial Operations

    ? Curetis plans to continue its EMEA commercial conversion campaign and to roll out new
    products (e.g. the recently launched Unyvero UTI Cartridge for urinary tract infections and
    the A30 RQ Platform, which will be further developed in 2018 and which is expected to
    be marketed under CE-mark in 2019) and plans to grow the installed base of Unyvero
    Analyzers and, upon commercial conversion of accounts, cartridge utilization on such
    installed base.
    ? Following the clearance of the Unyvero System and the Unyvero LRT Application
    Cartridge by the U.S. FDA in April 2018, the Company has initiated the commercial launch
    of the products in the U.S. in Q2-2018, with the goal of increasing the global installed base
    of Unyvero Analyzers. Based on an expected U.S. sales cycle of six to nine months, sales
    of the LRT Application Cartridge are anticipated to ramp up by the end of 2018. In this
    context, Curetis expects to experience positive revenue effects towards the end of 2018
    and going forward.
    The Company also strives to continuously evolve and expand its commercial distribution
    network across those EMEA markets that are not covered by direct sales and marketing
    teams. To that end, Curetis has recently hired Eneko Goya as Global Commercial Partner
    Manager, who has longstanding experience in sales and business development, to
    manage and expand the global commercial partner distribution channel.
    ? In line with the geographic expansion, in particular to the U.S. market and the further
    commercial roll-out in the markets covered directly or through distribution partners, the
    Company expects to significantly increase its global installed base of Unyvero Analyzers
    throughout 2018 and beyond. Starting from 175 Analyzers installed as of December 31,
    2017, Curetis in Q1-2018 exercised a buy-back option for several Analyzers previously
    used in a by now successfully completed clinical trial (Amikacin Phase III trial) by a
    pharmaceutical industry partner. Further, under new commercial leadership in the EMEA
    region, the direct sales strategy has taken a reinforced focus on higher priority accounts
    and commercial conversion effectiveness, which led to a temporary re-deployment and a
    temporary decreased number of the global installed base to 167 Analyzers by the end of
    Q1-2018. Building on this consolidated installed base, the Company is targeting to grow
    its total installed base to around 250 to 300 analyzers by the end of 2018. Of these, a
    growing number is expected to be placed in the U.S. following the clearance of the
    Unyvero System and the Unyvero LRT Application Cartridge by the U.S. FDA in April
    2018. Hence, Curetis USA Inc. within the next six to nine months targets the installation
    of around 40 to 50 Unyvero Analyzers across the U.S. and an increase to around 60 to
    80 Analyzers within the first year following full commercial launch (i.e. Q2-2019).
  9. [verwijderd] 30 april 2018 08:40
    Research & Development
    ? To further advance its U.S. product portfolio, Curetis expects to initiate sites for
    prospective patient sample enrollment into its second U.S. FDA clinical trial for the
    Unyvero IJI Invasive Joint Infection Application Cartridge beginning in H2-2018, with the
    aim of completing this trial in 2019. Curetis will also in the coming months initiate a
    dialogue with the U.S. FDA on the data requirements for a label claim expansion of its
    current Unyvero LRT Cartridge to also include bronchoalveolar lavage (BAL) as a sample
    type and the potential expansion of its panel to include one further microorganism and
    certain additional resistance markers to further strengthen the clinical utility of this first-inclass
    application. Further U.S. FDA trials are expected to follow, subject to access to
    additional funding, thus continuing the portfolio expansion of available differentiated
    testing applications in the U.S.
    ? The Company also anticipates that its Chinese partner Beijing Clear Biotech (BCB) is to
    complete all steps required by the Chinese regulatory agency CFDA in terms of analytical
    testing needed to initiate prospective clinical trials in China in the second half of 2018.
    The objective is to complete the first trials in 2019, with subsequent CFDA submission
    and approvals required for launch and commercialization in the Chinese market.
    ? With the recent launch of the Unyvero UTI Application Cartridge for severe urinary tract
    infections, the Company has further expanded its offering of Unyvero A50 high-multiplex
    syndromic panels for hospital-acquired infections. The Company expects to further
    develop and expand its Unyvero A50 application portfolio through stringent life-cycle
    management of its existing applications as well as through development of selected novel
    applications.
  10. [verwijderd] 30 april 2018 08:40
    In 2018, Curetis expects to work on further expanding the Unyvero platform beyond the
    core Unyvero A50 high-multiplex Analyzer and Unyvero A50 syndromic testing panels by
    advancing the development of the Unyvero A30 RQ Analyzer and additional application
    cartridges for this rapid, low- to mid-plex module to complement the Unyvero product
    offering as a broader platform in hospital infections. The Company expects to receive CEIVD
    marking for the Unyvero A30 RQ Analyzer as well as first A30 RQ Application
    Cartridges during the course of 2019.

    Business Development
    ? Following the broad strategic Memorandum of Understanding (MoU) signed with MGI (a
    BGI Group company, China) in September 2017 and the further collaboration and
    commercialization agreements under this MoU signed in January 2018, Curetis expects
    first results and initial product launches from this collaboration in the 2018 and 2019
    timeframe. Importantly, Curetis expects to continue to grow, broaden and deepen this
    strategic partnership with the BGI Group moving forward and to apply the Unyvero as well
    as Ares Genetics’ bioinformatics competencies and assets to their NGS platform to fuel
    future growth. Curetis expects that the Companies will also explore further options for
    strategic and commercial collaborations in China and beyond.
    ? Curetis also aims to enter into additional value-adding R&D and commercial partnerships
    with well-known players in the relevant industries that are based on the ARES AMR
    Database, ARESdb, and the ARES Technology Platform and/or the Unyvero A30 RQ
    Analyzer and further elements of the Unyvero Platform.
  11. [verwijderd] 30 april 2018 08:41
    Financial Position and Financing
    ? Building on stable year-over-year revenue in Q1-2018, a solid sales funnel in the EMEA
    region, the ongoing commercial launch in the U.S. and other developments described
    above, the Company aims to at least double its revenue year-over-year in 2018.
    ? With the expansion of the U.S. commercial organization in December 2017 and Q1-2018
    and the initiation of the U.S. commercial roll-out of the Unyvero System and the Unyvero
    LRT Application Cartridge as well as the continued development of the Unyvero A30 RQ
    Analyzer and further Unyvero Application Cartridges, in particular for the U.S. market (e.g.
    the Unyvero IJI Application Cartridge incl. clinical trials), the Company expects the net
    cash-burn from operating and investment activities for 2018 to be around 30 million EUR,
    an anticipated significant increase over cash burn of 15.7 million EUR in 2017.
    ? Curetis will continue to assess all tactical and strategic financing options in the debt and
    equity capital markets globally. With the cash available at year-end 2017 (plus VAT
    receivable of EUR 0.3 million) in combination with up to EUR 15 million of additional debt
    financing from the EIB that may become available for draw-down by Curetis upon it
    meeting several agreed upon milestones (including an additional EUR 3 million EIB debt
    tranche which became available immediately upon the April 2018 FDA clearance), and
    the EUR 4.1 million from the recent private share placements and access to additional
    USD 10 million in equity mentioned above, Curetis aims to raise additional growth capital
    as either equity or debt in 2018 to secure appropriate funding and cash for continued
    operations for at least 12 months to ensure it has the financial resources to continue as a
    going concern. Depending on commercial success and financing availability, Curetis also
    expects to further grow its employee base at its various international sites and operations
    in the coming years.
    Curetis also plans to pursue non-dilutive financing sources such as government grants or
    licensing and partnering models (e.g. for the Ares AMR Database and Unyvero A30 RQ
    Platform) to partially fund some of its operations in 2018 and 2019.
  12. DAGEVOS 30 april 2018 08:41
    Dus naast de 4,1 miljoen aan uitgifte verse aandelen komt er nog eens een uitgifte van 4 miljoen in aandelen in de vorm van leningen en daarnaast de krediet faciliteit van 10 miljoen. Dus de verwatering wordt ruim 8 miljoen in aandelen. Ook stijgen de investeringen pakweg 75 maal 40.000 euro. Tel uit je winst. 2019 kan pas beoordeeld worden of dit bedrijf werkelijk levensvatbaar is. Het is somber weer vandaag zo de koers.
  13. [verwijderd] 30 april 2018 08:53
    ipv ZR "tiepetjes" geschreeuw aan te horen, lijkt het me belangrijk de kranten en het nieuws te volgen, bijv:

    www.telegraaf.nl/financieel/1977353/c...

    AMSTERDAM - Curetis mikt dit jaar op een omzetverdubbeling. Dat maakte het in Amsterdam genoteerde Duitse biotechnologiebedrijf bekend bij de presentatie van zijn jaarcijfers.
    De opbrengsten kwamen het afgelopen jaar uit op 1,2 miljoen euro, tegenover 1,3 miljoen euro een jaar eerder. Het bedrijf zegt dit jaar te kunnen profiteren van onder meer de lancering van Unyvero in de Verenigde Staten.

    Onder de streep noteerde Curetis een verlies van 19,3 miljoen euro. Dat was een jaar eerder nog 16,3 miljoen euro. Curetis wijt het oplopen van het verlies onder meer aan kosten voor de commerciële uitbreiding en ontwikkelingskosten. Het operationele verlies ging van 15,2 miljoen naar 18,6 miljoen euro. Curetis had aan het einde van het jaar een kaspositie van 16,3 miljoen euro, drie ton minder dan in februari gemeld op basis van voorlopige cijfers.

    Bekende spelers
    De onderneming kijkt dit jaar naar waardeverhogende samenwerkingen op het vlak van onderzoek en ontwikkeling of commercie. Daarbij spreekt het van de ,,bekende spelers in de relevante sectoren".

    Curetis liet verder weten dat commissaris Holger Reithinger per direct vertrekt. Reithinger is al sinds 2011 betrokken bij Curetis als commissaris. Hij was naar voren geschoven door aandeelhouder Forbion, die momenteel een belang van 8,7 procent heeft. Curetis gaat vooralsnog verder met zes commissarissen, maar onderzoekt de mogelijkheden om de samenstelling tijdens de komende aandeelhoudersvergadering aan te passen.
  14. forum rang 7 lucas D 30 april 2018 08:53
    Op korte termijn weinig zicht op verbetering, belangrijk is ook of 2 mei de dan nieuw op de markt toegelaten aandelen worden vastgehouden of verzilvert.

    Vandaag is het vooral sentiment, 2 mei is voor de aandeelhouders belangrijker.

    Voor de lange termijn is dit een pauze in de ontwikkeling, kan een prachtig bedrijf worden, maar om nu al LT in te stappen is wel wat vroeg.
  15. forum rang 10 DeZwarteRidder 30 april 2018 08:59
    quote:

    PingPong22 schreef op 30 april 2018 08:53:

    Curetis liet verder weten dat commissaris Holger Reithinger per direct vertrekt. Reithinger is al sinds 2011 betrokken bij Curetis als commissaris. Hij was naar voren geschoven door aandeelhouder Forbion, die momenteel een belang van 8,7 procent heeft. Curetis gaat vooralsnog verder met zes commissarissen, maar onderzoekt de mogelijkheden om de samenstelling tijdens de komende aandeelhoudersvergadering aan te passen.
    Het lijkt erop dat Forbion zich gaat terugtrekken en graag wil verkopen.
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