Bli medlem
Bli medlem

Du är här


Curetis AG: Curetis Publishes First Quarter 2016 Business and Financial Update

Curetis AG / Curetis Publishes First Quarter 2016 Business and Financial
Update. Processed and transmitted by NASDAQ OMX Corporate Solutions. The
issuer is solely responsible for the content of this announcement.

- Worldwide commercial expansion and US FDA trial on track

- Installed base of Unyvero Analyzers increased to 107 devices

Amsterdam, the Netherlands and Holzgerlingen, Germany, May 20, 2016
-- Curetis N.V. (the "Company
" and, together with Curetis GmbH, "Curetis
"), a developer of next-level molecular diagnostic solutions, today published
its business update for the quarter ended March 31, 2016, and confirmed its
outlook for the full year 2016.

First Quarter 2016 Operational and Business Highlights

Unyvero US FDA trial

* TheUS FDA trial for theUnyvero LRT Application in lower respiratory tract
infections is nearing completion, with expected enrolment targets to be
reached by mid-year. At the end of March 2016, more than 1,600 patient
samples had been enrolled, with over 2,000 prospective and retrospective
patient samples enrolled to-date;
* Curetis anticipates completing the contrived specimen study, molecular
composite comparator testing for all samples and ancillary preclinical work
packages in the second half of 2016, with top line data expected to be
available upon unblinding, not before fall 2016;
* The submission of 510(k) data package to the US FDA is expected before
year-end 2016.
* The Company also continues to prepare for thesecond Unyvero Application
Cartridge to enter US FDA trials in the second half of 2016. Further
details will be announced later this year.

Commercial Expansion

* The Company hashired Willem Haagmans as Head of Sales EMEA . He brings a
strong track record and extensive leadership experience with both large and
small-to-medium sized molecular diagnostics companies. Prior to joining
Curetis, he worked as General Manager Benelux at Beckman Coulter.
Previously, Haagmans held international management positions at Roche,
Nimblegen, and Vela Diagnostics. In addition, the Company has hired
keycommercial staff in theUK, France andBenelux , significantly
strengthening its direct commercial footprint and positioning the Company
to accelerate new Unyvero installations in these key markets.
* Curetis has established awholly owned sales subsidiary in the UK (Curetis
UK Ltd, London, UK) at the beginning of May 2016 and anticipates to
incorporate further subsidiaries in France (Curetis France SARL) and the
Netherlands (Curetis Benelux BV) in the coming months.

Product Development

* Curetis has successfully completed the CE performance evaluation study and
subsequentlylaunched its Unyvero BCU Blood Culture Application Cartridge
during ECCMID 2016 in Amsterdam in April. The CE-marked BCU application is
designed for diagnosing infections spreading through the blood stream in
positively flagged blood cultures. The comprehensive panel covers 87 of the
most relevant pathogens, including Gram negative and Gram positive
bacteria, and 16 related resistance markers.
* The Company has advanced the development of asecond-generation Unyvero ITI
Application Cartridge (expected European launch in mid-2016) andIAI
Intra-Abdominal Infection Cartridge (expected development completion by
year-end 2016). In addition, the partneredSepsis Host Response program
(anticipated completion in late 2017) is progressing according to plan.
* Curetis has established a Medical Advisory Board with experts from the US
(Robin Patel, MD, Mayo Clinic), Belgium (Jean-Louis Vincent, MD, Erasme
University Hospital), Switzerland (Reno Frei, MD, University Hospital
Basel), and Germany (Mathias Pletz, MD, Jena University Hospital). The
advisors bring strong expertise in intensive care, clinical microbiology,
sepsis and prosthetic joint infections.

Recently, Curetis added Dr. Laurent Poirel (University of
Fribourg, Switzerland), an expert in antibiotic resistance markers, to its
MAB. Dr. Poirel has a long-standing scientific career at the French National
Institute of Health and Medical Research (INSERM) in Paris / France with a
focus on the genetics, biochemistry and epidemiology of antibiotic resistance
determinants. In addition, he and his team have jointly developed a variety
of rapid diagnostic tests for the detection of extended-spectrum ß-lactamases
and carbapenemases.

Installed Base

* Curetis hasexpanded the installed base of Unyvero Analyzers to 107 at the
end of the first quarter 2016 (vs. 58 at the end of the first quarter
* The Company reiterates its guidance of an expected global installed base of
150 to 200 Unyvero Analyzers by year-end 2016.

Supervisory Board

* Curetis announced thenomination of Dr. Prabhavathi Fernandes , CEO of
Cempra Pharmaceuticals Inc., Chapel Hill, NC, USA, as a candidate for
Curetis N.V.'sSupervisory Board . The election is to be held during the
upcoming Annual General Meeting on June 16, 2016. Further important
resolutions in the agenda are the resignation of Dr. Frank Mühlenbeck, and
the re-election of Dr. Holger Reithinger and Dr. Rudy Dekeyser for another
one-year term.

First Quarter 2016 Financial Highlights

* Revenues: EUR 132.8 k (vs. EUR 228.4 k in the first quarter 2015). In
general, revenues are expected to remain volatile from quarter-to-quarter,
as early-stage instrument sales to distribution partners are unevenly
spread throughout the year.
* Expenses : EUR 3.3 million (vs. EUR 2.7 million in the first quarter 2015).
The increase is in line with the operational and organizational growth, and
driven by higher R&D expenses, distribution costs as well as G&A costs only
partly compensated by less cost of sales.
* Gross loss: EUR 30.1 k (vs. EUR 54.2 k in the first quarter 2015). This is
mainly due to IFRS accounting requiring idle capacity of manufacturing line
and facility to be allocated to cartridge output.
* Net loss : EUR 3.2 million (vs. EUR 2.6 million in the first quarter 2015).

* Cash and cash equivalents : EUR 43.2 million (vs. EUR 46.1 million as of 31
Dec 2015). Net cash burn in the first quarter 2016 was EUR 2.9 million.

Key non-audited financials as of March 31, 2016

| Curetis N.V. |
| consolidated numbers in '000 Euros |
| For the three months ended For the three months ended |
| March 31, 2016 March 31, 2015 |
| Revenues 133 228 |
| Operating loss (3,125) (2,461) |
| Total comprehensive income (3,169) (2,588) |
| |
| March 31, 2016 December 31, 2015 |
| Cash and cash equivalents 43,190 46,060 |
"We are very pleased with the operational progress in the first quarter of
2016. Year-to-date, we have successfully tested more than 2,000 patient
samples in our FDA trial, with enrolment for prospective and retrospective
sample testing nearing completion. This progress keeps us on-track to report
top-line data from the trial during the latter part of 2016 and submit our
510(k) package to the FDA by year-end," said Oliver Schacht, CEO of Curetis.
"In addition to advancing our U.S. trial, we have strengthened our commercial
infrastructure through key sales hires in the UK, France and Benelux, and
additions to our application specialist and marketing teams in Germany."

"The expansion of our direct sales organization in Western Europe is fully on
track, and we continue to pursue strategic distribution partnerships aimed at
providing Unyvero access to additional markets and potentially bolstering our
presence in existing markets," he added. "The successful launch of our
Unyvero BCU Blood Culture Application Cartridge adds a third comprehensive
syndromic panel to the Unyvero Platform in Europe, further strengthening our
product portfolio. With several other cartridges in development and expected
to launch in the coming years, we believe that Curetis is optimally
positioned to succeed in the global MDx market."



CAUTION - Investigational device. Limited by Federal (or United States) law to
investigational use. The information contained in this communication does not
constitute nor imply an offer to sell or transfer any product, and no product
based on the Curetis Unyvero technology is currently available for sale in
the United States of America or Canada. The analytical and clinical
performance characteristics of any Curetis Unyvero product which may be sold
at some future point in time in the U.S. have not yet been established.


About Curetis

Founded in 2007, Curetis is a molecular diagnostics company which focuses on
the development and commercialization of reliable, fast and cost-effective
products for diagnosing severe infectious diseases. The diagnostic solutions
of Curetis enable rapid multi-parameter pathogen and antibiotic resistance
marker detection in only a few hours, a process that today can take up to
days or even weeks with other techniques.

To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam
and Euronext Brussels and private equity funds of over EUR 63.5 million. The
company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed
collaboration agreements with Heraeus Medical and Cempra Inc. as well as
several international distribution agreements covering many countries across
Europe, the Middle East and Asia.

For further information, please visit

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...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.