Curetis Announces Financial Results for the First Six Months of 2018

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Algemeen advies 14/08/2018 08:33
- Successful U.S. launch of Unyvero System and LRT Application Cartridge, with strong pipeline of sales opportunities
- Unyvero UTI Application Cartridge launched as CE-IVD product,
BCU and HPN Application Cartridges approved in Singapore
- Commercial reach expanded to Latin America and Northern Africa
Amsterdam, the Netherlands, Holzgerlingen, Germany, and San Diego, CA, USA, August 14, 2018, 01:30 am EDT -- Curetis N.V. (the "Company" and, together with its subsidiaries, "Curetis"), a developer of next-level molecular diagnostic solutions, today reported its financial results for the first six months ended June 30, 2018, and provided a business update for 2018 year-to-date and its outlook for the future.
Operational and Business Highlights 2018 Year-to-Date
Successful U.S. Launch of Unyvero System and LRT Cartridge
? Following the U.S.-FDA clearance in April 2018, Curetis launched the Unyvero System and the Unyvero LRT Application Cartridge for lower respiratory tract infections in the U.S. market at the ASM Microbe 2018 Congress in Atlanta, GA, USA on June 7, 2018.
? Since the launch, the U.S. commercial team has initially qualified more than 125 accounts as potential first buyers of Unyvero out of a total of about 1,000 hospitals considered by Curetis to be initial targets for Unyvero LRT. Of those qualified accounts, more than 50 have been thoroughly vetted and many are expected to be converted to commercial accounts over the next several quarters with approximately ten accounts constituting near-term opportunities currently at the contract negotiation stage. These initial ten accounts on average are expected to have LRT cartridge volumes of 700 to 800 annually once they become commercial customers. The estimated LRT cartridge volume potentials for the more than 50 accounts in advanced stages of qualification range from around 250 to over 1,600 p.a.
Commercial Development
? In all EMEA direct markets, combined revenues from cartridges and instruments grew by more than 257% comparing the first half 2018 with the first half of 2017. Total revenue was up by 36% compared to the first half of 2017.
? In August 2018, Curetis expanded its geographic presence into the Northern African and Latin American markets signing exclusive distribution partnerships with Future Horizon Scientific for Egypt, with Quimica Valaner S.A. for Mexico and with Biko S.A. for Uruguay. Each of the three new distribution partners intends to commercialize
all five Unyvero Application Cartridges that are currently CE-IVD-marked, namely HPN, ITI, BCU, IAI and UTI. These partners in total have committed to purchasing a minimum of 45 instrument systems at Curetis’ typical distributor transfer prices over the respective three-year contractual terms. In addition, they have committed to minimum purchases of several thousand Unyvero application cartridges over the terms of the agreements.
? With these additional distribution partnerships in place, Curetis to-date has 16 distribution partners covering 29 countries and believes to have a strong pipeline of further potential distribution partners covering additional markets that may lead to further near-term distribution agreements.
Installed Base
? Upon completion of a pharmaceutical partner’s phase III clinical trial, Curetis in Q1-2018 exercised an option to buy back multiple Unyvero Systems deployed in this clinical trial and has concurrently taken a stronger focus on higher priority accounts and conversion efficiency throughout H1-2018, which has led to a re-deployment of Unyvero Analyzers resulting in a temporary decrease in the installed base of Unyvero Analyzers to 162 Analyzers as of the end of the first half-year 2018, down by a net of 13 Analyzers compared to 175 Analyzers at year-end 2017. The Company expects to offset this decrease through future U.S. sales and the entry into additional distribution partnerships and has also identified a significant number of EMEA direct market opportunities for new Unyvero placements. Overall, the Company’s more selective placement of Unyvero Systems has resulted in improved working capital management in H1-2018.
Product Launches and Regulatory Approvals
? In April 2018, Curetis launched the CE-IVD marked Unyvero Urinary Tract Infection (UTI) Application Cartridge at ECCMID 2018. The UTI panel covers 103 diagnostic targets, including 88 pathogens and 15 resistance markers. Unyvero UTI primarily targets urinary tract infections in patients with complicated and severe UTIs.
? In April 2018, the Unyvero HPN and BCU Application Cartridges were approved by the Singapore Health Sciences Authority (HSA) and fully registered as Class C IVD medical devices with the Singapore Medical Device Register. The approval allows Curetis’ Singaporean distribution partner Acumen Research Laboratories Ltd. to initiate a more comprehensive roll-out in Singapore

see & read more on
http://www.curetis.com/uploads/tx_news/20180814_Curetis_PR_H1-18_BF-Update_EN_APPROVED.pdf

tijd 10.09
Curetis EUR 4,15 -17ct vol. 49.081



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