Curetis Publishes
Business and Financial Update for the First Nine Months of
2017
- Preparing for
expected U.S. FDA clearance decision on Unyvero System and Unyvero
LRT Application
- Second U.S.
FDA trial initiated for Unyvero IJI Application
Amsterdam, the Netherlands, and
Holzgerlingen, Germany, November 16, 2017; published at 02:00
a.m. EDT - Curetis N.V. (the "Company" and,
together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today
published a business and financial update for the first nine months
ended September 30, 2017, and provided details on its outlook for
the coming months.
Recent Operational and Business
Highlights
U.S. FDA Trials with Unyvero LRT and IJI
Application Cartridges
-
Curetis continues to work closely with the U.S.
FDA in the interactive review of the 510(k) submission for its Unyvero Platform and the
Unyvero LRT Lower Respiratory Tract Infection Cartridge.
-
Recently, Curetis completed all
agreed upon work packages, wet-lab testing and risk &
benefit analysis. In early November, Curetis also provided all of
its responses to the original AI (Additional Information) request
letter to the U.S. FDA's questions. Subject to completion of the
interactive review and subsequent final review, Curetis expects an FDA clearance decision in due course.
-
The Company continues to prepare for the commercial launch of Unyvero in the
U.S. in 2018, with recruiting activities underway for
additional commercial and operations positions, including clinical
application specialists and field service engineering support. A
further expansion of the team is in progress with the hiring of the
sales force in the field expected in the coming months.
-
As Curetis recognizes the importance of
antibiotic stewardship programs, and the goal of limiting
inappropriate use of antibiotics, Curetis USA Inc. hosted a KOL
roundtable discussion with PharmD Infectious Disease specialists in
the U.S. in San Diego during IDWeek.
-
Curetis has initiated a U.S.
FDA trial for its second U.S. product, the Unyvero Invasive
Joint Infections (IJI) Application Cartridge. Following
Institutional Review Board (IRB) approvals, Curetis has initiated
sample collection for its second multicenter FDA study. The IJI
Cartridge represents a newly developed U.S. version of the CE-IVD
marked Unyvero ITI Cartridge. The ITI Implant and Tissue Infection
Application is commercially available in Europe and other parts of
the world.
-
Among the sites that have
already entered the trial for sample collection of
microbiology-positive synovial fluid patient samples are sites that
previously participated in the Unyvero LRT trial (e.g. Beaumont
Hospital, Royal Oak, MI), as well as new sites (e.g. Froedtert
Hospital and the Medical College of Wisconsin, Milwaukee, WI), med
fusion, (Lewisville, TX) and a leading reference lab in the
Southwestern United States. The Company is expecting further
expansion of the network to include additional sites in the coming
months.
-
The overall trial design is
similar to the Unyvero LRT study. Following FDA guidance, the IJI
clinical trial is expected to enroll more than 1,500 prospective
test samples, complemented with archived microbiology-positive
specimens to reach significant numbers for each of the analytes in
the IJI panel, as well as a comprehensive analytical testing data
package. The Company expects availability of the cartridges and the
initiation of the prospective arm of the FDA trial
to begin in 2018.
Business Development and Market Expansion
- Following the announcement of a strategic
memorandum of understanding and initial R&D
collaboration between MGI (a BGI Affiliate) in China and
Curetis / Ares Genetics in September 2017, MGI has commenced a
feasibility study for Next-Generation Sequencing in-vitro
diagnostic assays for microbial infections. Together with MGI,
Curetis attended a major conference in China. Discussions and
negotiations between Curetis and MGI regarding future expansion of
their strategic collaboration are ongoing.
-
Ares Genetics GmbH, a wholly owned subsidiary of
Curetis, has advanced additional partnering
discussions pertaining to the genetic antibiotic and susceptibility
database GEAR to term sheet stage(s). Additional GEAR related
partnering activities are anticipated in the coming quarters.
- Curetis' partner Biotest to
enroll the first patient into the PEPPER clinical trial. This
is the fourth pharma partnership supported by Curetis. The Company
continues to explore further pharma clinical trials that might
benefit from the use of Unyvero.
-
The Unyvero System and its application
cartridges for pneumonia (HPN), implant and tissue infections (ITI)
and bloodstream infections (BCU), have recently been cleared by the regulatory authorities for commercial use in
Israel.
- Working toward a potential
Chinese market clearance, analytical testing of Unyvero HPN
Cartridges by BCB in China is progressing as expected. Analytical
testing is a key requirement and precondition to Curetis' partner
initiating the prospective Chinese FDA clinical trials in
2018.
- The regulatory review of the
Unyvero submission in Singapore is in
progress and it is anticipated that a clearance decision will
be made in the coming months.
Commercial Development
-
Following the shift of global
sales responsibility to Chris Bernard (announced in August
2017), there have been changes to the team composition and
organization in Curetis' EMEA direct selling markets. Riwat Lim has joined Curetis from QIAGEN as Managing
Director of Curetis UK Ltd. and Head of Marketing and Scientific
Affairs. To maximize synergies across all customer-facing teams and
given Riwat's deep expertise and strong leadership capabilities, he
has recently been appointed as Director of
Commercial Operations EMEA.
-
In his new role, Riwat leads and oversees all
EMEA commercial operations including Sales, Customer Support and
Services, Scientific Affairs and Marketing. Riwat will continue
shaping and evolving the EMEA commercial team.
Installed Base
-
Curetis has continued to expand
the installed base of Unyvero Analyzers to
165 as of September 30, 2017 (vs. 121 as of September 30, 2016), an
increase of 36.4% year over year. During Q3, 2017, a total of 9 new
Analyzers were installed and 5 were brought back following
completion of the demo and evaluation phase.
-
As expected, system
placements during the summer months have been slow. Also,
during the third quarter, Curetis has experienced some prolonged
customer discussions and contracting in Germany, France and the UK.
Therefore, several new system placements expected in the third
quarter have been postponed into Q4.
-
Furthermore, in the U.S., paperwork has been
signed for multiple Unyvero Analyzers to be
installed in the U.S. in Q4-2017 under an Investigational Use
Only (IUO) labeling. The U.S. impact on the overall installed base
will be relatively limited in FY 2017, but is expected to
accelerate significantly upon the planned commercial launch
following the anticipated FDA clearance decision.
-
Curetis USA Inc. is expected to place a
significant initial stocking order with Curetis GmbH in late
Q4-2017 for inventory purposes ahead of an anticipated U.S. launch
and commercial roll-out. Given the timing of this anticipated
order, the Company now expects to reach its installed base target
of 200 Unyvero Analyzers in Q1-2018 rather
than by 31 December 2017.
Product Development
-
Development of the Unyvero UTI
Urinary Tract Infection Cartridge has been completed and is
pending verification and validation. Curetis aims to launch this as a CE-IVD marked product at a major
European conference in Q2-2018.
-
Curetis has finalized the
specifications of the Invasive Joint Infections (IJI)
Application in collaboration with KOLs and clinical experts. As
detailed above, the Company has continued related application
development efforts in preparation for the second U.S. clinical
trial.
-
All other R&D programs and
product development projects continue to progress on track and
in line with Curetis' guidance. These projects include the
completion of development of a Unyvero Sepsis Host Response
Cartridge (SHR) which will be provided under an IUO
(Investigational Use Only) label for further clinical validation
and testing.
-
Curetis has integrated the former Gyronimo platform into the Unyvero suite of products as
the future Unyvero A30 RQ Analyzer, which will
add rapid and where needed quantitative testing capabilities. The
development program is on track for completion by the end of
2018.
Financial Highlights for the
First Nine Months 2017
-
Revenues: EUR 0.83 million
(vs. EUR 1.08 million in the nine months ended September 30, 2016).
As outlined above, a number of placements expected in Q3 have been
postponed to Q4-2017. 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 14.8 million
(vs. EUR 12.0 million in the nine months ended September 30, 2016).
The increase is in line with the operational and organizational
growth strategy and driven by higher R&D expenses, distribution
costs as well as G&A costs. The increase is also due to
non-cash expenses accounting for the newly implemented equity
settled stock option program 2016. This has resulted in expenses of
EUR 946k in the first nine months of 2017 (EUR 363k in the first
nine months of 2016).
-
Gross loss: EUR 0.66
million (vs. a gross loss of EUR 0.11 million in the nine months
ended September 30, 2016). The key driver of the higher COGS was
depreciation on Unyvero Systems by way of marketability discounts
totaling EUR 521k in the first 9 months of 2017 (EUR 268k in the
first nine months of 2016) as well as increased costs.
-
Net loss: EUR 14.6 million
(vs. a net loss of EUR 10.7 million in the nine months ended
September 30, 2016).
-
Cash and cash equivalents:
EUR 21.6 million as of September 30, 2017 (vs. EUR 22.8 million as
of December 31, 2015) and a net cash decrease of EUR 1.2 million
during the first nine months of 2017. The net cash outflow from
operating and investing activities was EUR 10.9 million (vs. EUR
10.5 million in the first nine months of 2016) with EUR 10.0
million cash inflow in Q2-2017 from the EIB debt financing tranche
draw-down.
Key non-audited financials as of
September 30, 2017
Curetis N.V. |
|
|
consolidated numbers in '000 Euros |
|
|
|
For the nine months ended September 30, 2017 |
For the nine months ended September 30, 2016 |
Revenues |
831 |
1,077 |
Operating loss |
(13,865) |
(10,760) |
Total comprehensive income |
(14,452) |
(10,731) |
|
|
|
|
September 30, 2017 |
September 30, 2016 |
Cash and cash equivalents |
21,561 |
35,415 |
"While we are awaiting the FDA clearance decision
for our Unyvero System and the LRT cartridge, we are busy preparing
for the commercial roll-out in the U.S.," said Dr. Oliver Schacht,
CEO of Curetis. "We have therefore realigned our global commercial
organization, which has also had a short-term impact on sales and
revenues in the EMEA region. However, we expect to be able to
partially offset the temporary decrease in system placements in the
fourth quarter this year and into early 2018. We are also very
confident that the market launch in the U.S. will be a major value
inflection point and key milestone for the company. Given our level
of confidence, we have initiated an FDA clinical trial of a second
U.S. product for the detection of invasive joint infections.
Looking ahead, we believe that both the continued commercial
expansion and the integration of last year's GEAR and Gyronimo
acquisitions will have an increasing impact on Curetis' long-term
growth prospects."
###
Disclaimer
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. Furthermore,
Curetis has entered into a debt financing facility with EIB for up
to EUR 25 million. The company is based in Holzgerlingen near
Stuttgart, Germany. Curetis collaborates with Heraeus Medical,
pharmaceutical companies, and has entered into several
international distribution agreements covering many countries
across Europe, the Middle East and Asia.
In 2017, Curetis established Ares
Genetics GmbH, a wholly-owned subsidiary of Curetis GmbH in Vienna,
Austria. Ares Genetics is dedicated to maximize the R&D and
related scientific and business opportunities of the GEAR assets
acquired in 2016 for the entire Curetis Group.
For further information, please
visit www.curetis.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
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
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