Curetis Reports Financial Results for the First Six Months of 2016
(Thomson Reuters ONE) -
Curetis /
Curetis Reports Financial Results for the First Six Months of 2016
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The issuer is solely responsible for the content of this announcement.
- Key business and commercial milestones and goals met
- Global presence further strengthened with subsidiaries in the U.S., UK, France
and the Netherlands
Amsterdam, the Netherlands, and Holzgerlingen, Germany, August 19, 2016 --
Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a
developer of next-level molecular diagnostic solutions, today reported its
financial results for the first six months ended June 30, 2016, and provided an
update on its financial and business guidance for the second half 2016 and
beyond.
Operational and Business Highlights 2016 to Date
* In April 2016, Curetis successfully completed the CE performance evaluation
study and subsequently launched its Unyvero BCU Blood Culture Application
Cartridge during ECCMID 2016 in Amsterdam. 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. Interim data from a prospective
multicenter evaluation showed 98% concordance with conventional microbiology
and Unyvero results were on average available 24 hours earlier than results
obtained by routine diagnostic methods.
* The U.S. FDA trial for the Unyvero LRT Application in lower respiratory
tract infections is almost completed. Prospective and retrospective sample
enrolment has been successfully concluded on schedule in the first half of
2016. In less than a year, a total number of more than 2,250 samples
including approximately 1,700 prospective and over 550 retrospective patient
samples, have been enrolled at nine clinical trial sites across the U.S.,
including, amongst others, Mayo Clinic, Northwestern University, Johns
Hopkins Hospital, UCLA and Columbia University Medical Center.
* Curetis has continued its commercial expansion in both the United States and
Europe. In the U.S., the Company has appointed Christopher M. Bernard as
President and Chief Executive Officer of the newly-formed North American
subsidiary Curetis USA, Inc.. Christopher Bernard is a seasoned executive
with significant expertise in sales, marketing and commercialization of in-
vitro diagnostic platforms. Prior to Curetis, he has worked in several
executive management roles at Epic Sciences, Metabolon, Inc., Abaxis, Inc.
and Cytyc Corporation (Hologic, Inc.). At Curetis, he will be responsible
for the development of the new subsidiary and will lead the marketing and
sales initiatives of Curetis in the U.S..
In Europe, the Company has hired 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, he
held international management positions at Roche, Nimblegen, and Vela
Diagnostics.
In addition, the Company has hired key commercial staff in the UK, France and
Benelux that is currently on boarded. This new staff will significantly
strengthen Curetis' direct commercial footprint and position the Company to
accelerate new Unyvero installations in these key markets.
Curetis has also established wholly owned sales subsidiaries in the UK in May
and in the Netherlands for the Benelux area in June and is in the process of
setting up an additional subsidiary in France.
* In June 2016, the Company signed an exclusive, three-year distribution
agreement with Axon Lab AG for Curetis' Unyvero products in Central and
Eastern European countries, including Austria, the Czech Republic, Slovakia,
Slovenia and Croatia.
* The Company is in the final stage of completing the development of a second-
generation Unyvero ITI Application Cartridge and is progressing the
development of its IAI Intra-Abdominal Infection Cartridge. In addition, the
partnered Sepsis Host Response program is progressing according to plan.
* Curetis has continued to expand the installed base of Unyvero Analyzers to
113 as of June 30, 2016 (vs. 70 instruments as of June 30, 2015).
* During the Annual Shareholder Meeting held on June 16, 2016, Dr. Prabhavathi
Fernandes, CEO of Cempra Pharmaceuticals Inc., Chapel Hill, NC, USA, has
been elected as a member of the Curetis N.V. Supervisory Board. Dr.
Prabhavathi Fernandes has profound knowledge in infectious diseases and
antibiotics as well as experience in successfully founding, building and
leading several biotech companies and taking one public on Nasdaq, raising
more than half a billion U.S. dollars. Moreover, Dr. Holger Reithinger and
Dr. Rudy Dekeyser were re-elected for another one-year term, respectively.
In addition, the proposed resignation of Dr. Frank Muehlenbeck, the creation
of a new Stock Option Program for the Company and associated changes to the
Supervisory Board remuneration policy as well as changes to the Management
Board's Remuneration Policy and Stock Option grants were also approved by
the shareholders.
* Additionally, 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, as well as Laurent Poirel, MD, University of Fribourg), and Germany
(Mathias Pletz, MD, Jena University Hospital). The advisors bring strong
expertise in intensive care, clinical microbiology, sepsis, prosthetic joint
infections, and antibiotic resistance.
Financial Highlights, First Half-Year 2016
* Revenues: EUR 655 thousand (vs. EUR 742 thousand in the first half-year of
2015).
* Expenses: EUR 7.5 million (vs. EUR 6.4 million in the first half-year of
2015).
* Gross loss: EUR 9 thousand (vs. a gross profit of EUR 77 thousand in the
first half-year of 2015).
* Net loss: EUR 6.7 million (vs. EUR 12.4 million in the first half-year ended
June, 30 2015).
* Cash and cash equivalents: EUR 39.7 million as of June 30, 2016 (vs. EUR
46.1 million as of December 31, 2015).
* Net cash burn in the first half-year 2016 was EUR 6.4 million.
Anticipated Milestones
* For the U.S. FDA trial with the Unyvero LRT Application in lower respiratory
tract infections, Curetis targets completion of 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 after un-blinding.
* The submission of Curetis' (de novo) 510(k) data package to the U.S. FDA is
anticipated by year-end 2016 with the goal of achieving FDA clearance for
Unyvero and starting commercialization in the first half of 2017.
* The Company has begun preparing to enter U.S. FDA trials for its next U.S.
product. To that end, Curetis has already submitted a so-called pre-
submission package to the U.S. FDA in which the Company has outlined the
intended use claims and a proposed study design for a U.S. version of its
Unyvero ITI Cartridge. Depending on the FDA's feedback later this year, the
Company will determine appropriate next steps and timelines for a U.S. FDA
trial for its second U.S. product. Further details will be announced later
this year.
* The Company and its partner BCB are progressing the regulatory trials for
product clearance in China with important data and preclinical parts of the
trial expected to be run in H2-2016 under the auspices of the Beijing
Institute of Medical Device Testing of the Beijing Center for Medical Device
Quality Supervision and Testing of the Chinese State Food and Drug
Administration (CFDA). BCB has expressed its goal to obtain CFDA clearance
in 2017 and to begin commercialization in mainland China thereafter.
Commercial efforts in Hong Kong and Taiwan, which are not subject to first
obtaining CFDA approval, have already begun with a first commercial
installation at a major hospital in Hong Kong successfully completed in
July.
* Curetis' partner Acumen has recently submitted a filing to the regulatory
authorities in Singapore with the goal of achieving regulatory clearance for
the Unyvero HPN (Hospitalized Pneumonia) Application which is equivalent to
the current EU P55 Pneumonia cartridge. Acumen has also started preparing
respective filing documents for the Unyvero BCU Blood Culture Application
and plans to apply for the ITI Application once the second-generation has
been CE-IVD marked in Europe. Regulatory approval for the Unyvero Platform
and Products is expected not before 2017.
* The Japanese Patent Office has decided to grant a key patent for the Unyvero
Platform combining PCR amplification and array-based detection in the
Unyvero Cartridges. The patent will become effective with the issuance of an
official note by the Japanese patent office.
* The European launch of the second-generation Unyvero ITI Application
Cartridge is expected in Q3-2016. Completion of development of the IAI
Intra-Abdominal Infection Cartridge is planned by year-end 2016. Moreover,
the partnered Sepsis Host Response program is anticipated to be completed
not before the end of 2017.
* Together with its Medical Advisory Board, the Company is in the process of
defining and prioritizing multiple additional new infectious disease
indication areas of high unmet medical need for further Unyvero Cartridge
developments and will update its product pipeline shortly.
* With the commercial teams in all European direct selling markets now in
place and getting up to speed, the Company believes that there are several
dozen well-qualified Unyvero placement opportunities for H2-2016. Therefore,
the Company reiterates its guidance of an expected global installed base of
150 to 200 Unyvero Analyzers by year-end 2016.
* Following the formation of Curetis USA, Inc. in San Diego, CA, and the start
of recruitment of a core team of senior U.S. marketing and sales leadership,
the Company is planning direct commercialization of all Unyvero products in
the U.S. hospital market.
* Further Curetis subsidiaries are to be incorporated in France and
Switzerland in Q3-2016.
"We are very satisfied that we could meet our key corporate milestones in the
first six months of 2016," said Oliver Schacht, Chief Executive Officer of
Curetis. "As our product and commercial development is progressing well, we are
convinced that we can continue to deliver on the anticipated milestones
communicated during our IPO. The market launch of our BCU Cartridge and the
expected roll-out of our second-generation ITI and the new IAI Application
Cartridges provide opportunities for further commercial upside. With our EMEA
team fully built out by mid-year, we are now looking forward to accelerating our
commercial momentum in the second half of 2016."
Financial Development and Guidance
For the six months ended June 30, 2016, revenues were EUR 655 thousand, as
compared to revenues of EUR 742 thousand in the same period 2015. While revenues
in the first half of 2015 included EUR 297 thousand Unyvero Systems sales to a
pharma partner, revenues in the same period in 2016 did not include any such
system sales to pharma. 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 in the first six months of 2016 amounted to EUR 7.5 million (vs. EUR
6.4 million in the first half-year 2015). The increase is in line with the
operational and organizational growth and driven by higher R&D expenses,
increased marketing, sales and distribution costs as well as G&A costs.
Gross loss for the first six months of 2016 totaled EUR 9 thousand, compared
with a gross profit of EUR 77 thousand for the same period in 2015. The
relatively low gross margin is mainly due to IFRS accounting requiring idle
capacity of manufacturing line and facility to be allocated to cartridge output.
Net loss for the first six months of 2016 was EUR 6.7 million compared with a
net loss of EUR 12.4 million in the same period in 2015.
As of June 30, 2016, the Company had a strong cash position of EUR 39.7 million
cash on hand and a net cash burn of EUR 6.4 million for all operating,
investment and financing activities combined. The company expects a cash
position of 31 to 32 million at the end of 2016.
Earnings Conference Call and Webcast
Curetis will host a public earnings conference call and webcast today, August
19, 2016, at 03:00pm CET / 09:00am EST to discuss the financial results of the
first six months 2016, highlight the most important events and provide an
outlook for the second half 2016 and beyond.
The conference call will be supplemented by a presentation which can be accessed
during the call at http://www.curetis.com/en/investors/financial-reports-and-
conferences/financial-reports.html (participants' passcode curetis0816).The live
webcast and a replay will be available at http://curetis120416-live.audio-
webcast.com
To access the call, please dial the following numbers using the passcode
93120684#
D: +49 69 222229043
NL: +31 1071 372 73
UK: +44 20 30092452
US: +1 855 4027766
For further international dial-in numbers, please open the following link:
http://events.arkadin.com/ev/docs/International%20Access%20Numbers_%20UKFELBRI1_
SU7.pdf
The first half-year financial report 2016 will be available as of today, August
19, 2016, at http://www.curetis.com/en/investors/financial-reports-and-
conferences/financial-reports.html
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. 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 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(at)curetis.com or ir(at)curetis.com
www.curetis.com - www.unyvero.com
International Media & Investor Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(at)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(at)theruthgroup.com
Tel. +1 646 536 7012
CURETIS N.V.
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
(UNAUDITED)
For the period ended June 30, 2016
+--------------------------------------------+----------------+----------------+
| |six months ended|six months ended|
|in Euro | June 30, 2016| June 30, 2015|
+--------------------------------------------+----------------+----------------+
| | | |
| | | |
|Revenue | 654,682| 742,035|
| | | |
|Cost of sales | 663,657| 665,151|
+--------------------------------------------+----------------+----------------+
|Gross loss / gross margin | -8,975| 76,884|
+--------------------------------------------+----------------+----------------+
| | | |
| | | |
|Distribution costs | 2,095,227| 1,396,725|
| | | |
|Administrative expenses | 1,406,161| 1,365,739|
| | | |
|Research & development expenses | 3,301,211| 2,943,167|
| | | |
|Other income | 85,976| 41,235|
+--------------------------------------------+----------------+----------------+
|Operating loss | -6,725,598| -5,587,512|
+--------------------------------------------+----------------+----------------+
| | | |
| | | |
|Finance income | 61,343| 5,493|
| | | |
|Finance costs | 41,127| 8,866|
| | | |
|Finance income / costs fair value | | |
|measurement | 0| 6,782,819|
+--------------------------------------------+----------------+----------------+
|Finance costs - net | 20,216| -6,786,192|
+--------------------------------------------+----------------+----------------+
| | | |
+--------------------------------------------+----------------+----------------+
|Profit / loss before income tax | -6,705,382| -12,373,704|
+--------------------------------------------+----------------+----------------+
|Income tax expenses | -| -|
+--------------------------------------------+----------------+----------------+
|Profit / loss for the half- year | -6,705,382| -12,373,704|
+--------------------------------------------+----------------+----------------+
|Other comprehensive income for the half- | | |
|year, net tax | 6,044| -|
+--------------------------------------------+----------------+----------------+
|Total comprehensive income for the half-year| -6,699,338| -12,373,704|
+--------------------------------------------+----------------+----------------+
Comparative figures for six months ended June 30, 2015, are those of Curetis
GmbH (former AG).
CURETIS N.V.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION - ASSETS (UNAUDITED)
As of June 30, 2016
+----------------------------------------------+-------------+-----------------+
|in Euro |June 30, 2016|December 31, 2015|
+----------------------------------------------+-------------+-----------------+
| | | |
+----------------------------------------------+-------------+-----------------+
|Current assets | 45,115,373| 50,573,547|
+----------------------------------------------+-------------+-----------------+
| Cash and cash equivalents | 39,708,145| 46,060,397|
| | | |
| Trade receivables | 589,879| 1,072,131|
| | | |
| Inventories | 4,395,280| 2,786,887|
| | | |
| Other current assets | 422,069| 654,132|
| | | |
| | | |
+----------------------------------------------+-------------+-----------------+
|Non-current assets | 6,033,064| 6,823,465|
+----------------------------------------------+-------------+-----------------+
| Intangible assets | 573,324| 645,120|
| | | |
| Property, plant and equipment | 4,928,949| 5,605,496|
| | | |
| Other non-current assets | 236,788| 223,846|
| | | |
| Other non-current financial | | |
| assets | 294,003| 349,003|
| | | |
| Deferred tax assets | -| -|
| | | |
| | | |
+----------------------------------------------+-------------+-----------------+
|Total assets | 51,148,437| 57,397,012|
+----------------------------------------------+-------------+-----------------+
CURETIS N.V.
CONSOLIDATED STATEMENT OF FINANCIAL POSITION -
LIABILITY & EQUITY (UNAUDITED)
As of June 30, 2016
+----------------------------------------------+-------------+-----------------+
| in Euro |June 30, 2016|December 31, 2015|
+----------------------------------------------+-------------+-----------------+
| | | |
+----------------------------------------------+-------------+-----------------+
|Current liabilities | 3,014,748| 2,446,095|
+----------------------------------------------+-------------+-----------------+
| Trade and other payables | 974,908| 863,342|
| | | |
| Liability PSOP | 367,308| 367,308|
| | | |
| Provisions current | 2,300| 29,300|
| | | |
| Other current liabilities | 959,471| 676,502|
| | | |
| Other current financial | | |
| liabilities | 710,761| 509,643|
| | | |
| | | |
+----------------------------------------------+-------------+-----------------+
|Non-current liabilities | 38,035| 155,926|
+----------------------------------------------+-------------+-----------------+
| Provisions non-current | 38,035| 38,035|
| | | |
| Other non-current financial | | |
| liabilities | -| 117,891|
| | | |
| | | |
+----------------------------------------------+-------------+-----------------+
|Total liabilities | 3,052,783| 2,602,021|
+----------------------------------------------+-------------+-----------------+
| | | |
+----------------------------------------------+-------------+-----------------+
|Equity | 48,095,654| 54,794,991|
+----------------------------------------------+-------------+-----------------+
| Share capital | 155,384| 155,384|
| | | |
| Capital reserve | 152,793,347| 152,793,347|
| | | |
| Other reserves | 6,592,373| 6,592,372|
| | | |
| Currency translation | | |
| differences | 6,044| -|
| | | |
| Retained earnings | -111,451,494| -104,746,112|
| | | |
| | | |
+----------------------------------------------+-------------+-----------------+
|Total equity and liabilities | 51,148,437| 57,397,012|
+----------------------------------------------+-------------+-----------------+
CURETIS N.V.
CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED)
For the period ended June 30, 2016
+--------------------------------------------+----------------+----------------+
|in Euro |six months ended|six months ended|
| | | |
| | June 30, 2016| June 30, 2015|
+--------------------------------------------+----------------+----------------+
|Profit before income tax | -6,705,382| -12,373,704|
| | | |
|Adjustment for: | | |
| | | |
|- Net finance income / costs | -20,216| 6,786,192|
| | | |
|- Depreciation, amortization and impairments| 897,324| 834,625|
| | | |
|- Gain on disposal of fixed assets | 1,550| 1,889|
| | | |
|- Changes in provisions | -26,998| 1,444,870|
| | | |
|- Net exchange differences | 39,316| -4,635|
| | | |
| | | |
| | | |
|Changes in working capital relating to: | | |
| | | |
|- Inventories | -1,608,393| -45,528|
| | | |
|- Trade receivables and other receivables | 756,373| -351,259|
| | | |
|- Trade payables and other payables | 547,066| 181,731|
| | | |
| | | |
| | | |
|Effects of exchange rate differences not | | |
|realized from consolidation | 6,044| 0|
| | | |
|Income taxes received (+) / paid (-) | 0| 0|
| | | |
|Interests paid (-) | -41,127| -3,373|
+--------------------------------------------+----------------+----------------+
|Net cash flow provided by operating | | |
|activities | -6,154,443| -3,529,192|
+--------------------------------------------+----------------+----------------+
|Payments for intangible assets | -3,524| -2,230|
| | | |
|Payments for property, plant and equipment | -147,008| -251,606|
| | | |
|Interests received | 61,343| 1,889|
+--------------------------------------------+----------------+----------------+
|Net cash flow used in investing activities | -89,189| -251,947|
+--------------------------------------------+----------------+----------------+
|Payments for finance lease liabilities | -69,304| -66,078|
| | | |
|Cash received from capital increase | 0| 6,789,027|
+--------------------------------------------+----------------+----------------+
|Net cash flow provided by financing | | |
|activities | -69,304| 6,722,949|
+--------------------------------------------+----------------+----------------+
| | | |
+--------------------------------------------+----------------+----------------+
|Net increase (decrease) in cash and cash | | |
|equivalents | -6,312,936| 2,941,810|
+--------------------------------------------+----------------+----------------+
|Net cash and cash equivalents at the | | |
|beginning of the year | 46,060,397| 2,993,883|
| | | |
|Net increase (decrease) in cash and cash | | |
|equivalents | -6,312,936| 2,941,810|
| | | |
|Effects of exchange rate changes on cash and| | |
|cash equivalents | -39,316| 4,635|
+--------------------------------------------+----------------+----------------+
|Net cash and cash equivalents at the end of | | |
|the half-year | 39,708,145| 5,940,328|
+--------------------------------------------+----------------+----------------+
Comparative figures for six months ended June 30, 2015, are those of Curetis
GmbH (former AG)
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