-
Revenue increases by 64% to EUR 2.3 million, up from 1.4
million in 2018
-
More than tripled total contract order volume received
year-over-year to about EUR 3.4 million 2019
-
Curetis N.V. shareholders to vote on March 10, 2020 on
planned business combination with OpGen, Inc.
Amsterdam, the Netherlands,
Holzgerlingen, Germany, and San Diego, CA, USA, February 20,
2020, 08:00 am CET -- Curetis N.V. (the
"Company" and, together with its subsidiaries,
"Curetis"), a developer of next-level molecular
diagnostic solutions, today announced preliminary. unaudited
condensed combined key financials for the fiscal year 2019 and
provided a business update for 2020 year-to-date.
Revenue of the Curetis business in 2019 amounted
to EUR 2.3 million, up by 64% compared to EUR 1.4 million in 2018.
This revenue was realized from a total contract order volume of
about EUR 3.4 million received in 2019, up by a factor of more than
three comparted to contract order volume in 2018 (EUR 1.1
million). Revenue growth in 2019 was primarily driven by partnering
projects of Curetis Group Company Ares Genetics as well as
increasing uptake of Curetis’ Unyvero product line. Preliminary,
unaudited operating loss of the condensed combined business for
fiscal year 2019 was approximately EUR 17.2 million compared to EUR
21.6 million in 2018, an improvement of about 21%. This improvement
is mainly driven by significant reductions in operating costs for
R&D as well as distribution (marketing and sales) and comes
despite significantly increased G&A costs that were driven by
one-off transaction-related expenses for the preparation and
implementation of the proposed business combination.
Key accomplishments of the Curetis business in
2020 year-to-date include:
- Curetis’ launch of the Unyvero LRT Panel for BAL specimens in
the U.S. following receipt of 510(k) clearance by the U.S. FDA in
December 2019. The panel includes atypical pathogens such as
Pneumocystis jirovecii important for immunocompromised patients and
is commercially available to Curetis’ U.S. customers since end of
January 2020. The LRT BAL panel is expected to substantially
increase the total addressable market for the Unyvero System in the
U.S.
- Curetis GmbH’s subsidiary Ares Genetics’ collaboration with BGI
Group to offer Next-Generation Sequencing (NGS) and PCR-based
Coronavirus (2019-nCoV) testing in Europe.
- Curetis GmbH and Quaphaco entered into an exclusive
distribution partnership for Vietnam for an initial term of three
years with Quaphaco committing to a minimum purchase totaling
approximately EUR 1.9 million during such initial term.
Business combination with OpGen
Inc.
The Company also announced the following updates
relating to the planned business combination with OpGen, Inc.,
Gaithersburg, MD, USA (OpGen):
- OpGen’s preliminary unaudited total revenue for 2019 increased
by 18.7% to US$3.5 million, up from US$3.0 million in 2018. Such
revenue growth was driven by Acuitas AMR Gene Panel and Acuitas®
Lighthouse revenue, which increased 147% to approximately $1.4
million while revenues from OpGen’s rapid FISH products decreased
approximately 12% to $2.1 million.
- OpGen’s preliminary, unaudited operating loss for fiscal year
2019 was approximately $12.4 million compared with $13.4 million in
2018.
- Patient accrual is underway since December to support FDA
submission for the OpGen’s lead rapid molecular diagnostic test,
the Acuitas® AMR Gene Panel Urine for the Acuitas AMR Gene Panel
(Urine) FDA De Novo clearance clinical trial;
- OpGen is working interactively with the FDA to provide final
responses to Additional Information Request Letters for the Acuitas
AMR Gene Panel (Isolates) pending FDA 510(K) submission. The
response process to the FDA is anticipated to be completed in
February to be followed by formal response filings; and
- OpGen achieved the planned program milestone under the New York
State Infectious Disease Digital Health Initiative demonstration
project.
Evan Jones, Chairman & CEO of OpGen,
commented, “We were pleased with the initial results from fiscal
year 2019 and we look forward to further progress following the
expected first FDA clearance of our AMR Gene Panel products. Our
teams have been working closely with Curetis to complete the
planned business combination of our two companies. Together we have
exciting prospects for growth from our combined product
portfolios.”
Oliver Schacht, CEO of Curetis, commented, “We
are encouraged by the significant progress of our business in 2019
and of our planned business combination with OpGen. The initial
launch of the new Unyvero LRT BAL panel opens a significant
additional opportunity in the U.S. market. Several prestigious
medical centers, including a major cancer center and a large
academic institution, have already committed to evaluate the
Unyvero LRT BAL panel for routine use in patients hospitalized for
suspected pneumonia. The Unyvero LRT BAL application is the first
and only FDA-cleared molecular diagnostic pneumonia panel that
includes Pneumocystis jirovecii. This difficult to diagnose
pathogen is a leading cause of pneumonia in immunocompromised
individuals.”
The preliminary financial results of Curetis and
OpGen are estimates prior to the completion of the companies’
financial closing procedures and audit procedures by its external
auditors and therefore may be subject to adjustment when the actual
results are available.
OpGen and Curetis entered into a definitive
agreement to combine businesses on September 4, 2019. The closing
of the transaction under such definitive agreement has not yet
occurred and is subject to a number of significant closing
conditions, including receipt of approval from the stockholders of
OpGen, Inc. and the shareholders of Curetis, N.V. To this end,
OpGen filed and furnished to its stockholders a proxy
statement/prospectus and a notice of special meeting of OpGen
stockholders to be held on March 10, 2020 to approve the business
combination with Curetis. On the same day at 1:00pm CET, Curetis
will host its extraordinary shareholder meeting with the objective
of seeking approval from its shareholders for the planned business
combination with OpGen.
Until the closing occurs, each of OpGen and
Curetis are operating as stand-alone businesses.
###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.
About OpGen
OpGen, Inc. is a precision medicine company
harnessing the power of molecular diagnostics and informatics to
help combat infectious disease. We are developing molecular
information products and services for global healthcare settings,
helping to guide clinicians with more rapid and actionable
information about life threatening infections, improve patient
outcomes, and decrease the spread of infections caused by
multidrug-resistant microorganisms, or MDROs.Our molecular
diagnostics and informatics products, product candidates and
services combine our Acuitas molecular diagnostics and Acuitas
Lighthouse informatics platform for use with our proprietary,
curated MDRO knowledgebase. We are working to deliver our products
and services, some in development, to a global network of customers
and partners. The Acuitas AMR Gene Panel (RUO) is intended for
Research Use Only and is not for use in diagnostic procedures. The
Acuitas Lighthouse Software is not distributed commercially for
antibiotic resistance prediction and is not for use in diagnostic
procedures. For more information, please visit www.opgen.com.
OpGen, Acuitas, and Acuitas Lighthouse are
registered trademarks of OpGen, Inc.
Curetis’ 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. 4271088 HolzgerlingenGermanyTel. +49
7031 49195-10pr@curetis.com or ir@curetis.comwww.curetis.com
- www.unyvero.com
Curetis’ International Media & Investor
Inquiries
akampionDr. Ludger Wess / Ines-Regina Buth Managing
Partnersinfo@akampion.com Tel. +49 40 88 16 59 64Tel. +49 30 23 63
27 68
OpGen Contact
Michael FarmerVice President, Marketing (240) 813-1284
mfarmer@opgen.comInvestorRelations@opgen.com
OpGen Press Contact
Matthew Bretzius FischTank Marketing and PR
matt@fischtankpr.com
OpGen Investor Contact
Joe GreenEdison Group jgreen@edisongroup.com
- 20200220_Curetis_PR_Business_Update_Final_Approved
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