Curetis Announces Financial Results for the First Three Months of 2019
May 17 2019 - 01:00AM
Curetis Announces Financial Results for
the First Three Months of 2019
- Total year-on-year revenue growth of
approximately 45%
- Successful implementation of corporate
re-organization and significant reduction of cost base
- Exclusive
pan-European distribution partnership with A. Menarini
Diagnostics
Amsterdam, the Netherlands,
Holzgerlingen, Germany, and San Diego, CA, USA, May 17,
2019, 07:00 am CET -- 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 three months ended March 31, 2019, and provided a business
update for 2019.
Key Operational and Business Updates
Commercial Development
- Total global revenue was up by
approximately 45% compared to the first three months of
2018.
- The total installed base of Unyvero Analyzers at the
end of Q1-2019 has increased to 172 Analyzers compared to
167 at year-end 2018, following a temporary decrease in global
installed base in 2018 due to various factors, e.g. repurchased
units due to the completion of a pharma project and efficiencies in
working capital deployment.
- As of March 31, 2019, Curetis USA Inc. had an installed
base of 15 Unyvero Analyzers across the USA in different
types of hospitals and laboratories. Clinical and commercial
evaluations are ongoing at multiple of these accounts.
- Following the re-organization of Curetis USA Inc. in January
2019, which has reduced the size of the team in the USA to
currently 11 full-time staff primarily based in the field, Curetis
USA Inc. is building on a solid funnel of target accounts
and opportunities and expects to increase the
installed base of Unyvero Analyzers in the U.S. to about 30 to 40
by year-end 2019, with a continuously growing proportion
of installations at commercial accounts in the second half of
2019.
- On March 26, 2019, Curetis and A. Menarini Diagnostics
(Menarini) announced an exclusive strategic pan-European commercial
distribution partnership. Initially, this partnership
covers 11 countries, including key markets such as Germany, France,
UK, Italy, Spain, Portugal, Switzerland, Benelux and Sweden.
- Following the successful re-organization of Curetis GmbH
initiated in December 2018 and largely completed at the end of
Q1-2019, Curetis will maintain a strong and highly
experienced commercial partner support team and customer
service. This team will support Menarini as well as all
other international distribution partners in EMEA, Asia, and Latin
America in broadly commercializing the Unyvero A50 product
line.
Market Access Asia
- Beijing Clear Biotech (BCB),
Curetis’ distribution partner for the Unyvero A50 System and
Application Cartridges in Greater China, in
Q1-2019 submitted an application for the Unyvero System and
HPN Application Cartridge to the Chinese NMPA (formerly
CFDA). The submission follows the successful completion of
analytical testing in 2018 and the expansion of the
strategic collaboration between Curetis and BCB in October
2018. In an initial response, the NMPA has proposed an expert panel
discussion for the HPN pneumonia product to be convened in summer
2019. Assuming that any potential further data requirements by NMPA
can be satisfied in 2019 and will allow for an NMPA approval in
2020, Curetis anticipates initial revenues from commercial
sales in China starting in 2020.
- Curetis’ partner for the
ASEAN region, Acumen Research Laboratories, in
Q1-2019 obtained regulatory approvals for the
Unyvero System and HPN as well as BCU Application Cartridges in
Malaysia and Thailand.
Business Development
- Following the strategy change
announced in December 2018, business development in Q1-2019 focused
on a broad range of business discussions, technical
feasibility demonstrations, licensing negotiations, and due
diligence procedures around the Unyvero A30 RQ Platform.
These ongoing discussions with numerous interested parties span all
key geographies in Europe, the USA and Asia and cover various
clinical indication areas such as infectious diseases and
oncology.
- Menarini and Curetis are
also foreseeing a further expansion of the existing
collaboration to potentially include additional EMEA
markets that might become available for distribution in the
future.
Product Development
- The Unyvero A30 RQ
Platform is aimed at strategic partnering and licensing
later in 2019 and has made excellent R&D
progress in Q1-2019. First fully functional instrument
system prototypes have been available since Q4-2018. Also, first
multiplex real-time PCR assays have been successfully transferred
onto the A30 RQ Cartridges and successfully benchmarked with
regards to their performance against standard PCR instruments. The
goal is to have the A30 RQ Platform ready for
partnering as well as verification and validation testing
with assays by first licensing partners from H2-2019
onwards.
- With the current Unyvero LRT
Application Cartridge for lower respiratory tract (LRT) infections
being cleared for the use with tracheal aspirates as a sample type,
Curetis plans to file for the clearance of an LRT
Application Cartridge optimized for use with bronchoalveolar lavage
(BAL) as additional sample type. BAL is another common
sample type for the diagnosis of lower respiratory tract
infections. It is estimated that BAL samples account for half of
the samples obtained for the diagnosis of lower respiratory tract
infections and Curetis believes that a clearance of an Unyvero LRT
Application Cartridge for this additional sample type would
increase the total addressable market for Unyvero in the U.S.
accordingly. In Q1-2019, Curetis successfully completed the
analytical testing and significantly progressed the clinical
validation testing of the LRT BAL Application Cartridge.
Clinical data are expected in Q2-2019 and the FDA submission for a
510(k) is anticipated in mid-2019.
- In addition, Curetis has continued
the collection of retrospective samples for its U.S. trials for the
Unyvero IJI Invasive Joint Infection
Cartridge to augment the future prospective arm of
the clinical trial. Moreover, a sample stability testing study has
been initiated at multiple U.S. sites in Q1-2019. An initiation of
the prospective arm of the trial, however, will depend on the
closing of a development and commercialization
partnership for this cartridge.
- At ECCMID 2019 in Amsterdam (April 13-16, 2019), a total of
nine clinical data sets and studies with Unyvero
applications across many different indication areas such
as pneumonia, joint infections, blood stream infections, and
intra-abdominal infections were presented.
Ares Genetics
- Ares Genetics signed an
exclusive global bioinformatics licensing and collaboration
agreement with QIAGEN in February 2019. This is the
third strategic collaboration agreement following the deals with
Sandoz and an undisclosed global IVD corporation in Q4-2018.
- Ares Genetics announced the
expected mid-2019 launch of its next-generation sequencing
(NGS) lab service offering. To that end, Ares has begun
building its lab infrastructure and operations team in Vienna,
Austria.
- In Q1-2019, Ares also
received co-funding by the Vienna Business Agency for a EUR
1.3 million project to advance AI-powered NGS called
“Triple-A” (Assay Development and
Artificial Intelligence to Diagnose
Antibiotic Resistant Infections).
- In collaboration with the Curetis
team, Ares Genetics released a beta testing version of the
AMR Atlas, a knowledge base of antimicrobial
resistance markers specifically designed to support users of the
Curetis Unyvero Platform. The initial focus of the Unyvero AMR
Atlas is on antibiotic resistance markers detected by the Unyvero
HPN Application Cartridge in pneumonia patients.
Financing
- Following the financing in November 2018, Curetis
continues to explore additional strategic and tactical financing
options. In Q1-2019, the Company primarily focused on
finding an agreement with EIB for the next EUR 5.0 million debt
financing tranche.
- In 2019 year-to-date, Yorkville has converted a total of EUR
1.5 million in notes into equity. A total of 1,290,726 new shares
have been issued in 2019 so far and Curetis expects to also access
a further EUR 1.5 million (gross) tranche of the Yorkville
convertible notes facility in 2019.
First Three Months 2019 Key Financials
- Revenues: EUR 708
thousand (growing by approximately 45% compared to EUR 490 thousand
in the three months ended March 31, 2018).
- Expenses: EUR
5,180 thousand total cost of sales, distribution costs,
administrative expenses and research & development expenses
(vs. EUR 6,081 thousand in the first three months of 2018). The
decrease is mainly based on the successful implementation of the
recent re-organization and reduction in organizational size,
complexity and staffing levels as well as R&D pipeline and
commercial channel partnering and revised commercial strategy.
- Operating loss:
The operating loss in Q1-2019 has been reduced by approximately 19%
to EUR -4,413 thousand (vs. EUR -5,412 thousand in the first three
months of 2018).
- Total comprehensive loss
for the period: EUR -4,746 thousand (vs. EUR -5,701
thousand in the first three months of 2018).
- Cash and cash
equivalents: EUR 6,158 thousand as of March 31, 2019 (vs.
EUR 10,279 thousand as of December 31, 2018). Net cash burn in the
first three months ended March 31, 2019, was EUR -4,326
thousand.
Non-Audited Key Financials as of March 31,
2019
Curetis N.V. |
consolidated numbers in thousand Euros |
|
For the three months ended March 31, 2019 |
For the three months ended March 31, 2018 |
Revenues |
708 |
490 |
Operating loss |
-4,413 |
-5,412 |
Total comprehensive loss |
-4,746 |
-5,701 |
|
|
|
|
March 31, 2019 |
December 31, 2018 |
Cash and cash equivalents |
6,158 |
10,279 |
###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 DetailsCuretis
N.V.Max-Eyth-Str. 4271088 Holzgerlingen, GermanyTel. +49 7031
49195-10pr@curetis.com or ir@curetis.comwww.curetis.com
- www.unyvero.com
International Media & Investor
InquiriesakampionDr. Ludger Wess / Ines-Regina Buth
Managing Partnersinfo@akampion.comTel. +49 40 88 16 59 64Tel. +49
30 23 63 27 68
- 20190517_Curetis_PR_Q1_EN_FINAL_approved
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