Curetis Announces Financial Results for the First Six Months of 2018
- 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
Commercial Development
Installed Base
Product Launches and Regulatory Approvals
Business Development
Product Development
Ares Genetics
Scientific Advisory Board
Annual General Meeting (AGM) and Supervisory Board
Financial Highlights H1-2018, Financing
Outlook
Going forward, Curetis expects to:
"We achieved a key corporate milestone in the first half of 2018 with the FDA clearance and commercial launch of the Unyvero System and Unyvero LRT Application Cartridge in the U.S.," said Oliver Schacht, Chief Executive Officer of Curetis. "As the largest molecular diagnostics market in the world, the U.S. is crucial not only for Curetis, but for all diagnostics companies, and our U.S. launch has been a major value inflection point for Curetis. To broaden our U.S. product offering, we are currently conducting an FDA trial for our second U.S. product, Unyvero IJI for invasive joint infections, and are seeking U.S. FDA input on the most efficient regulatory approach to extend the label claim for the Unyvero LRT Application Cartridge to BAL samples. In addition, we have significantly broadened our global commercial reach by closing exclusive distribution partnerships for Mexico, Uruguay and Egypt, and have significantly advanced in our efforts to gain market access in China."
Conference Call and Webcast
Curetis will host a public conference call and webcast on August 14, 2018, at 12:30 pm CEST / 06:30 am EDT to present the H1-2018 financial results, highlight the most important events and provide an outlook for the second half of 2018 and beyond.
The conference call will be supplemented by a presentation, which can be accessed during the call at:
http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html
For participating in the earnings conference call, please access the presentation at https://webcasts.eqs.com/curetis20180814
To access the call, please dial the following numbers using the passcode 93120684#:
NL: +31 107137273
BE: +32 11500307
DE: +49 6922 222 9043
UK: +44 2030 092 452
US: +1 855 4027766
China: +86 4006815483
Hong Kong: +852 30773565
Further country-specific dial-in numbers can be found at: http://events.arkadin.com/ev/docs/International Access Numbers_ UKFELBRI1_SU7.pdf
The full H1-2018 Report will be available as of 14 August 2018, at: http://www.curetis.com/en/investors/financial-reports-and-conferences/financial-reports.html
The live webcast and a replay will be available at: https://webcasts.eqs.com/curetis20180814
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About Curetis
Curetis N.V.'s (Euronext: CURE) goal is to become a leading provider of innovative solutions for molecular microbiology diagnostics designed to address the global challenge of detecting severe infectious diseases and identifying antibiotic resistances in hospitalized patients.
Curetis' Unyvero System is a versatile, fast and highly automated molecular diagnostic platform for easy-to-use, cartridge-based solutions for the comprehensive and rapid detection of pathogens and antimicrobial resistance markers in a range of severe infectious disease indications. Results are available within hours, a process that can take days or even weeks if performed with standard diagnostic procedures, thereby facilitating improved patient outcomes, stringent antibiotic stewardship and health-economic benefits. Unyvero in vitro diagnostic (IVD) products are marketed in Europe, the Middle East, Asia and the U.S.
Curetis' wholly owned subsidiary Ares Genetics GmbH offers next-generation solutions for infectious disease diagnostics and therapeutics. The ARES Technology Platform combines what the Company believes to be the most comprehensive database worldwide on the genetics of antimicrobial resistances, ARESdb, with advanced bioinformatics and artificial intelligence.
For further information, please visit www.curetis.com and www.ares-genetics.com.
Legal Disclaimer
This document constitutes neither an offer to buy nor an offer to subscribe for securities and neither this document nor any part of it should form the basis of any investment decision in Curetis.
The information contained in this press release has been carefully prepared. However, Curetis bears and assumes no liability of whatever kind for the correctness and completeness of the information provided herein. Curetis does not assume an obligation of whatever kind to update or correct information contained in this press release whether as a result of new information, future events or for other reasons.
This press release includes statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "targets," "may," "will," or "should" and include statements Curetis makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Curetis' actual results may differ materially from those predicted by the forward-looking statements. Curetis undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
Contact details
Curetis' Contact Details
Curetis N.V.
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr@curetis.com or ir@curetis.com
www.curetis.com - www.unyvero.com
International Media & Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
U.S. Media & Investor Inquiries
The Ruth Group
Lee Roth
lroth@theruthgroup.com
Tel. +1 646 536 7012
CURETIS N.V.
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME (UNAUDITED)
For the periods ended 30 June 2018 and 30 June 2017
in kEuro | Six months ended 30 June 2018 | Six months ended 30 June 2017 |
Revenue | 807 | 595 |
Cost of sales | -1,435 | -1,052 |
Gross loss | -628 | -457 |
Distribution costs | -4,214 | -3,846 |
Administrative expenses | -2,111 | -1,848 |
Research & development expenses | -4,683 | -3,161 |
Other income | 271 | 50 |
Operating loss | -11,365 | -9,262 |
Finance income | 274 | 20 |
Finance costs | -496 | -406 |
Finance results - net | -222 | -386 |
Loss before income tax | -11,587 | -9,648 |
Income tax expenses | 26 | -14 |
Loss for the period | -11,561 | -9,662 |
Other comprehensive income for the period, net of tax* | -171 | 117 |
Total comprehensive loss for the period** | -11,732 | -9,545 |
Loss per share attributable to the ordinary equity holders of the company | Six months ended 30 June 2018 | Six months ended 30 June 2017 |
Basic | -0.73 | -0.61 |
Diluted | -0.73 | -0.61 |
* Relates to exchange differences on translation of foreign operations, which may be recycled through profit and/or loss in the future
** Total comprehensive loss is solely attributable to owners of the company
CURETIS N.V.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (UNAUDITED) - ASSETS
As of 30 June 2018 and 31 December 2017
in kEuro | 30 June 2018 | 31 December 2017 | |
Current assets | 20,348 | 24,009 | |
Cash and cash equivalents | 11,646 | 16,311 | |
Trade receivables | 250 | 200 | |
Inventories | 6,891 | 6,946 | |
Other current assets | 1,561 | 552 | |
Non-current assets | 11,156 | 11,506 | |
Intangible assets | 7,511 | 7,524 | |
Property, plant and equipment | 3,193 | 3,566 | |
Other non-current assets | 172 | 182 | |
Other non-current financial assets | 157 | 156 | |
Deferred tax assets | 123 | 78 | |
Total assets | 31,504 | 35,515 |
CURETIS N.V.
STATEMENT OF FINANCIAL POSITION (UNAUDITED) - EQUITY AND LIABILITIES
As of 30 June 2018 and 31 December 2017
in kEuro | 30 June 2018 | 31 December 2017 | |
Current liabilities | 3,180 | 2,926 | |
Trade and other payables | 447 | 928 | |
Provisions current | 54 | 124 | |
Tax liabilities | 26 | 24 | |
Other current liabilities | 1,442 | 1,226 | |
Other current financial liabilities | 1,211 | 624 | |
Non-current liabilities | 13,647 | 10,385 | |
Provisions non-current | 43 | 43 | |
Other non-current financial liabilities | 13,604 | 10,342 | |
Total liabilities | 16,827 | 13,311 | |
Equity | 14,677 | 22,204 | |
Share capital | 164 | 155 | |
Capital reserve | 156,565 | 152,793 | |
Other reserves | 8,954 | 8,527 | |
Currency translation differences | -30 | 143 | |
Retained earnings | -150,976 | -139,414 | |
Total Equity and liabilities | 31,504 | 35,515 |
CURETIS N.V.
STATEMENT OF CASH FLOWS (UNAUDITED)
For the periods ended 30 June 2018 and 30 June 2017
in kEuro | Six months ended 30 June 2018 | Six months ended 30 June 2017 |
Profit after income tax | -11,561 | -9,663 |
Adjustment for: | ||
- Net finance income / costs | 222 | 386 |
- Depreciation, amortization and impairments | 618 | 694 |
- Changes in provisions | -70 | 35 |
- Changes in equity settled stock options | 427 | 822 |
- Net exchange differences | -249 | 217 |
- Changes in deferred tax assets and liabilities | -45 | 0 |
Changes in working capital relating to: | ||
- Inventories | 55 | -336 |
- Trade receivables and other receivables | -1,050 | 1,071 |
- Trade payables and other payables | 612 | 94 |
Effects of exchange rate differences not realized from consolidation | 76 | -100 |
Income taxes received (+) / paid (-) | -26 | -14 |
Interest paid (-) | -471 | -175 |
Net cash flow provided by operating activities | -11,462 | -6,969 |
Payments for intangible assets | -67 | -51 |
Payments for property, plant and equipment | -163 | -152 |
Interest received | 0 | 6 |
Net cash flow used in investing activities | -230 | -197 |
Proceeds from other non-current financial liabilities | 3,000 | 10,000 |
Payments for finance lease liabilities | 0 | -48 |
Proceeds from issue of ordinary shares | 4,100 | 0 |
Payments for financing costs of issue of ordinary shares | -320 | 0 |
Net cash flow provided by financing activities | 6,780 | 9,952 |
Net increase (decrease) in cash and cash equivalents | -4,912 | 2,786 |
Net cash and cash equivalents at the beginning of the year | 16,311 | 22,832 |
Net increase (decrease) in cash and cash equivalents | -4,912 | 2,786 |
Effects of exchange rate changes on cash and cash equivalents | 247 | -217 |
Net Cash and cash equivalents at the end of the period | 11,646 | 25,401 |
CURETIS N.V.
CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY (UNAUDITED)
As of 30 June 2018 and 30 June 2017
Share | Capital | Other | Currency | Retained | TOTAL | |
In kEuro | capital | reserve | reserve | transl. diff. | earnings | equity |
Balance at 1 January 2017 | 155 | 152,793 | 7,360 | -28 | -119,918 | 40,362 |
Loss of H1-2017 | -9,663 | -9,663 | ||||
Other comprehensive income | 117 | 117 | ||||
Total comprehensive income | 0 | 0 | 0 | 117 | -9,663 | -9,546 |
Transactions with owners in their capacity as owners | ||||||
Equity stock option program 2016 | 822 | 822 | ||||
Balance as of 30 June 2017 | 155 | 152,793 | 8,182 | 89 | -129,581 | 31,638 |
Share | Capital | Other | Currency | Retained | TOTAL | |
in kEuro | capital | reserve | reserve | transl. diff. | earnings | equity |
Balance at 1 January 2018 | 155 | 152,793 | 8,527 | 143 | -139,414 | 22,204 |
Loss of H1-2018 | -11,562 | -11,562 | ||||
Other comprehensive income | -173 | -173 | ||||
Total comprehensive income | 0 | 0 | 0 | -173 | -11,562 | -11,735 |
Transactions with owners in their capacity as owners | ||||||
Issue of ordinary shares | 9 | 4,091 | 4,100 | |||
Transaction costs for the issue of ordinary shares | -319 | -319 | ||||
Equity stock option program 2016 | 427 | 427 | ||||
Balance as of 30 June 2018 | 164 | 156,565 | 8,954 | -30 | -150,976 | 14,677 |