- Launched Unyvero System and Unyvero LRT Cartridge in the U.S.
- Increased revenues to EUR 1.4 million in 2018
- Raised EUR 19.5 million additional funding
- Revised focus and strategy
Amsterdam, the Netherlands, and Holzgerlingen, Germany, April 11, 2019 – 08:00 am CET -- Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the financial results for the twelve months ended December 31, 2018, and provided an updated guidance for 2019.
Key Events 2018 and Year-to-Date 2019
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 increasingly focused on higher priority accounts and conversion efficiency throughout 2018. This led to a re-deployment of Unyvero Analyzers and a temporary decrease in the installed base of Unyvero Analyzers to 167 Analyzers as of the end of 2018, down by a net of 8 Analyzers compared to 175 Analyzers at year-end 2017.
2018 Key Financials
Commenting on Curetis’ 2018 results, the Company´s CEO Oliver Schacht, stated: “In 2018, a major step for Curetis has been the granting of the De Novo request by the FDA in April and the subsequent U.S. launch of the Unyvero Platform and Unyvero LRT Cartridge for pneumonia. While this milestone has enabled us to raise an additional EUR 19.5 million funding during the course of 2018 in multiple transactions, the overall financing goals were not fully reached. We have therefore taken decisive action in December 2018 to focus on key value drivers and made significant changes to our strategy, commercial channels and R&D pipeline priorities. The necessary re-organization has led to a workforce reduction by approximately 25%. Re-prioritizing several R&D programs and a more partnering-driven strategy should allow us to reduce cash burn significantly in 2019. In light of available financial resources and funding for Curetis, we have also made the strategic decision to streamline our European commercial operations by moving from a direct sales model in key European markets towards an external distribution model in 2019. With A. Menarini Diagnostics, we have found an ideal partner to execute this strategy.”
Anticipated 2019 Milestones and Guidance
Commercial Operations and Business Development
Research & Development
Financial Position and Financing
Full-Year 2018 Financial Results
For the twelve months ended December 31, 2018, revenues amounted to EUR 1.4 million, as compared to revenues of EUR 1.2 million in 2017.
Gross loss for the year totaled EUR -814 thousand, compared with a gross loss of EUR -462 thousand in 2017 due to higher write-downs on Unyvero systems to reflect marketability discounts. The full-year 2018 gross margin was -57.4% compared with -38.9% for 2017.
Operating loss in 2018 totaled EUR -22.9 million compared with EUR -18.6 million in 2017.
Total comprehensive loss for the year was EUR -24.0 million compared with a total comprehensive loss of EUR -19.3 million in 2017 due to expenses related to the commercial expansion, R&D and pipeline expansion efforts.
On December 31, 2018, Curetis Group’s cash, cash equivalents and financial assets amounted to EUR 10.3 million (including the EIB loan facility drawdown of EUR 3 million in 2018, the drawdown of the first tranche of the Yorkville convertible notes totaling EUR 3.5 million and the equity financings closed in April and November 2018, respectively) compared with EUR 16.3 million as of December 31, 2017.
The financial statements 2018 have been prepared on a going concern basis despite the fact that as of December 31, 2018, remaining cash reserves were insufficient to cover at least 12 months after the sign-off date from the full-year 2018 report. However, detailed scenario analysis risk assessments were conducted as well as all strategic and tactical financing options assessed with several additional cash inflows such as another EUR 5.0 million EIB debt tranche available upon the waiver of condition precedent, potential Yorkville convertible notes tranche, possible future PIPE financing transactions based on authorized share capital and various cost reduction and cash preserving measures identified and implemented in Q4-2018 and Q1-2019, respectively.
Earnings Conference Call and Webcast
Curetis will host a public earnings conference call and webcast today, April 11, 2019, at 03:00 pm CET / 09:00 am EST to discuss the financial results of 2018, highlight the most important events and provide an outlook for 2019 and beyond.
For participating in the earnings conference call, please access the presentation at:
https://webcasts.eqs.com/curetis20190411/no-audio
To access the call, please dial the following numbers:
Belgium: +3224019516
Germany: +4969201744220
The Netherlands: +31207168020
UK: +442030092470
US: +18774230830
When instructed, please use the passcode 46052411#
For further international dial-in numbers, please open the following link:
http://events.arkadin.com/ev/docs/International%20Access%20Numbers_%20UKFELBRI1_SU7.pdf
The conference webcast can be accessed after completion of the call at: https://curetis.com/investors/#financial-reports
The full annual financial report 2018 is available as of today, April 11, 2019, at:
https://curetis.com/investors/#financial-reports
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 is developing next-generation solutions for infectious disease diagnostics and therapeutics. The ARES Technology Platform combines the presumably 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 to subscribe 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”, “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 GmbH
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 7031 49195-10
pr@curetis.com or ir@curetis.com
www.curetis.com
Curetis 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
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
in kEuro | 2018 | 2017 |
Revenue | 1,419 | 1,187 |
Cost of sales | -2,233 | -1,649 |
Gross loss | -814 | -462 |
Distribution costs | -8,155 | -7,302 |
Administrative expenses | -4,095 | -3,755 |
Research & development expenses | -10,568 | -7,362 |
Other income | 721 | 314 |
Operating loss | -22,911 | -18,567 |
Finance income | 406 | 21 |
Finance costs | -1,204 | -1,004 |
Finance result - net | -798 | -983 |
Loss before income tax | -23,709 | -19,550 |
Income tax expenses | -36 | 52 |
Loss for the period | -23,745 | -19,498 |
Other comprehensive income for the period, net of tax | -283 | 171 |
Total comprehensive loss for the period | -24,028 | -19,327 |
Loss per share attributable to the ordinary equity holders of the company | 2018 | 2017 |
Basic | -1.41 | -1.26 |
Diluted | -1.41 | -1.26 |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
Assets
in kEuro | 31 December 2018 | 31 December 2017 | |
Current assets | 18,095 | 24,009 | |
Cash and cash equivalents | 10,279 | 16,311 | |
Trade receivables | 323 | 200 | |
Inventories | 6,734 | 6,946 | |
Other current assets | 759 | 552 | |
Non-current assets | 11,012 | 11,506 | |
Intangible assets | 7,425 | 7,524 | |
Property, plant and equipment | 3,196 | 3,566 | |
Other non-current assets | 162 | 182 | |
Other non-current financial assets | 158 | 156 | |
Deferred tax assets | 71 | 78 | |
Total assets | 29,107 | 35,515 |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
Liability & Equity
in kEuro | 31 December 2018 | 31 December 2017 | |
Current liabilities | 6,064 | 2,926 | |
Trade and other payables | 957 | 928 | |
Provisions current | 65 | 124 | |
Tax liabilities | 22 | 24 | |
Other current liabilities | 1,235 | 1,226 | |
Other current financial liabilities | 3,785 | 624 | |
Non-current liabilities | 13,993 | 10,385 | |
Provisions non-current | 44 | 43 | |
Other non-current financial liabilities | 13,949 | 10,342 | |
Total liabilities | 20,057 | 13,311 | |
Equity | 9,050 | 22,204 | |
Share capital | 209 | 155 | |
Capital reserve | 162,967 | 152,793 | |
Other reserves | 9,176 | 8,527 | |
Currency translation differences | -143 | 143 | |
Retained earnings | -163,159 | -139,414 | |
Total equity and liabilities | 29,107 | 35,515 |
CONSOLIDATED STATEMENT OF CASH FLOWS
in kEuro | ||
2018 | 2017 | |
Loss after income tax for the period | -23,745 | -19,498 |
Adjustment for: | ||
- Net finance income / costs | 798 | 983 |
- Depreciation, amortization and impairments | 1,256 | 1,327 |
- Gain on disposal of fixed assets | 0 | 2 |
- Changes in provisions | -60 | 75 |
- Changes in equity settled stock options | 649 | 1,167 |
- Net exchange differences | -375 | 371 |
- Changes in deferred tax assets and liabilities | 7 | -78 |
Changes in working capital relating to: | ||
- Inventories | 212 | -1,076 |
- Trade receivables and other receivables | -312 | 1,008 |
- Trade payables and other payables | 659 | 911 |
Effects of exchange rate differences not realized from consolidation | 89 | -199 |
Income taxes received (+) / paid (-) | 36 | -52 |
Interest paid (-) | -1,173 | -622 |
Net cash flow used in operating activities | -21,959 | -15,681 |
Payments for intangible assets | -118 | -111 |
Payments for property, plant and equipment | -669 | -320 |
Interest received | 0 | 10 |
Net cash flow used in investing activities | -787 | -421 |
Proceeds from other non-current financial liabilities | 3,000 | 10,000 |
Proceeds from current financial liabilities | 3,109 | 0 |
Payments for finance lease liabilities | 0 | -48 |
Proceeds from issue of ordinary shares | 13,200 | 0 |
Payments for financing costs for issue of ordinary shares | -2,972 | 0 |
Net cash flow provided by financing activities | 16,337 | 9,952 |
Net decrease / increase in cash and cash equivalents | -6,409 | -6,150 |
Net cash and cash equivalents at the beginning of the year | 16,311 | 22,832 |
Net decrease in cash and cash equivalents | -6,409 | -6,150 |
Effects of exchange rate changes on cash and cash equivalents | 377 | -371 |
Net Cash and cash equivalents at the end of the period | 10,279 | 16,311 |
Attachment