NANOBIOTIX : 2014 ANNUAL RESULTS
(Thomson Reuters ONE) -
Small but heading for the big time
Nanobiotix: 2014 Annual Results
Paris, France, 14 April, 2015 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company pioneering novel
approaches for the local treatment of cancer, announces today its audited
consolidated results for the fiscal year ended December 31, 2014:
* Revenue increased mainly as a result of a milestone payment received from
PharmaEngine to develop the Soft Tissue Sarcoma indication in the Asia-
Pacific region;
* Expenses were impacted by Nanobiotix's R&D expansion, which has taken lead
product NBTXR3 into pivotal phase II/III trials in Soft Tissue Sarcoma and
pilot studies in Head and Neck cancer.
Philippe MAUBERNA, Chief Financial Officer of Nanobiotix commented: "This has
been an important year for Nanobiotix. The two fundraisings completed in 2014
have put Nanobiotix in a strong cash position. The additional ?38.5m raised in
2014 should enable us to execute our global strategic development and in
particular the preparation for an anticipated CE mark of NBTXR3 by the end of
2016."
· Income statement
+-------------+-------------+
| 2014 (1) | 2013 |
+------------------------------------------+-------------+-------------+
| Total revenue ? | 2,770,795 | 1,595,466 |
+------------------------------------------+-------------+-------------+
| Sales | 967,500 | 184,938 |
| | | |
| Other revenue | 1,803,295 | 1,410,528 |
| Subsidies | 314,764 | 80,973 |
| Research Tax Credit | 1,483,122 | 1,324,517 |
| Other | 5,408 | 5,038 |
| | | |
| Cost of sales | - | - |
| | | |
| R&D costs | (8,075,723) | (6,025,677) |
| | | |
| General costs | (4,062,591) | (3,151,249) |
| | | |
| Costs associated with payments in shares | (252,257) | (597,958) |
+------------------------------------------+-------------+-------------+
| Core operating loss | (9,619,777) | (8,179,418) |
+------------------------------------------+-------------+-------------+
| Financial gain / (charges) (*) | 142,522 | 34,497 |
+------------------------------------------+-------------+-------------+
| Core pre-tax loss | (9,477,255) | (8,144,920) |
+------------------------------------------+-------------+-------------+
| Tax | (79,271) | - |
+------------------------------------------+-------------+-------------+
| Net Profit & Loss | (9,556,525) | (8,144,920) |
+------------------------------------------+-------------+-------------+
* cost of net financial debt and other financial expenses
(1) non audited accounts
· Financial Review
NANOBIOTIX's sole source of revenue corresponds to the payments received from
its Taiwanese partner, PharmaEngine, within the framework of the licensing
contract. This contract is for the development and marketing of NBTXR3 in the
Asia-Pacific region. In total, the upfront payment received in August 2012 was
?810,640. The revenue has been deferred using the straight-line method between
the date the contract was signed and the scheduled marketing launch in that
region.
For the 12 months ended 31 December 2014, the pro-rata share of revenue was
?183,892. Revenue for the year also includes a milestone payment of $1.0m
(?783,607) received from PharmaEngine in October 2014 reflecting the fact that
PharmaEngine will join Nanobiotix's pivotal trial for NBTXR3 in Soft Tissue
Sarcoma to accelerate the product's development in the Asia-Pacific region. In
accordance with the contract between Nanobiotix and PharmaEngine, Nanobiotix is
eligible to receive development and commercialization milestone payments up to
$56.0m plus tiered, up to double-digit royalties on all net product sales in the
Asia-Pacific region.
Total revenue includes subsidies and research tax credit which have risen
sharply, as levels of R&D have increased during the 2014.
R&D costs increased by ?2m in line with the accelerated pipeline development,
particularly around the progress of the lead product, NBTXR3. NBTXR3, which is
currently being tested in patients with advanced Soft Tissue Sarcoma (STS),
entered product registration phase (pivotal) in October 2014. Depending on the
results, this could allow the Company to obtain a CE mark in late 2016. NBTXR3
is also being developed in Head and Neck cancer. The Company aims to expand its
clinical development program, in the second half-year of 2015, with new high
potential indications in the US and Europe: liver cancers (primary and
metastatic) and prostate cancer. The NanoXray platform is also being developed
in two other administration pathways, a gel form that is applied in the tumor
bed during surgery (NBTX-TOPO), and as an intravenous injection (NBTX-IV). R&D
costs reflect also the strengthening of the teams to support pipeline
development.
General and administration costs recorded by the Company increased by ?0.9m in
line with expectations. These costs are mostly due to the new US strategic
development and preparation of all steps to future commercialization.
The core operating loss was ?9,619,777 (FY13: loss ?8,179,418).
The financial gain was ?142,522 (FY13: financial gain of ?34,497) which
corresponds to interest income on the short term bank deposits following both
capital increases of 2014.
The tax recorded in 2014 relates to the tax withholding from the PharmaEngine
milestone payment of US$1m related to PharmaEngine joining Nanobiotix's pivotal
trial in Soft Tissue Sarcoma.
The net loss was ?9,556,525 (FY13: loss 8,144,920).
· Post year end events
In February 2015, the Company announced that Professor Robert Langer, Institute
Professor at the Massachusetts Institute of Technology (MIT), became a
Scientific Advisor to Nanobiotix. Professor Langer presides over the largest
academic biomedical engineering laboratory in the world. Beyond his extensive
involvement and leadership in MIT's scientific community, Professor Langer's
research has spawned a vast array of innovative and disruptive technologies. He
holds over 1,000 patents in diverse areas of biomedical technology and has been
involved in the launch or acceleration of numerous biotech companies.
Moreover, in March 2015, Nanobiotix appointed its Manufacturing Partner,
CordenPharma. The new manufacturing line, located in France, will increase the
amount of NBTXR3 product available. With a CE mark anticipated in 2016, the
Company is preparing to scale-up production further to meet the needs of future
commercialization. Furthermore, Nanobiotix is anticipating an increase in demand
for product for clinical trials in the coming years in Europe and in the United
States. The opening of a new manufacturing line and the scaling up of production
are important steps in NBTXR3's route to commercialization.
***
Next financial press release: revenue for Q1 2015 on May 15, 2015.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage
nanomedicine company pioneering novel approaches for the local treatment of
cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to provide a new, more efficient treatment for
cancer patients. NanoXray products are compatible with current radiotherapy
treatments and are meant to treat potentially a wide variety of cancers
including Soft Tissue Sarcoma, Head and Neck Cancer, Liver Cancers, Prostate
Cancer, Breast Cancer, Glioblastoma, etc., via multiple routes of
administration.
Nanobiotix's lead product NBTXR3, based on NanoXray, is currently under clinical
development for Soft Tissue Sarcoma and locally advanced Head and Neck Cancer.
The Company has partnered with PharmaEngine for clinical development and
commercialization of NBTXR3 in Asia.
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN:
FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company, based in
Paris, France, opened an affiliate office in the Boston area of the United
States in September 2014.
Contact
--------------------------------------
Nanobiotix
--------------------------------------
Sarah Gaubert
Head of Communication and Public
Affairs
+33 (0)1 40 26 07 55
contact(at)nanobiotix.com
-------------------------------------------------------------------------------
Media relations
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France - NewCap Outside France - Instinctif Partners
Annie-Florence Loyer Melanie Toyne Sewell / Ruth Ashton /
+33 (0)6 88 20 35 59 Emma Barlow
afloyer(at)newcap.fr +44 (0) 207 457 2020
nanobiotix(at)instinctif.com
Disclaimer
This press release contains certain forward-looking statements concerning
Nanobiotix and its business. Such forward-looking statements are based on
assumptions that Nanobiotix considers to be reasonable. However, there can be no
assurance that the estimates contained in such forward-looking statements will
be verified, which estimates are subject to numerous risks including the risks
set forth in the reference document of Nanobiotix registered by the
French Financial Markets Authority (Autorité des marchés financiers) on November
25, 2014 under number R.14-071 (a copy of which is available on
www.nanobiotix.com) and to the development of economic conditions, financial
markets and the markets in which Nanobiotix operates. The forward-looking
statements contained in this press release are also subject to risks not yet
known to Nanobiotix or not currently considered material by Nanobiotix. The
occurrence of all or part of such risks could cause actual results, financial
conditions, performance or achievements of Nanobiotix to be materially different
from such forward-looking statements.
This press release and the information that it contains do not constitute an
offer to sell or subscribe for, or a solicitation of an offer to purchase or
subscribe for, Nanobiotix shares in any country.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: NANOBIOTIX via GlobeNewswire
[HUG#1911158]
Datum: 14.04.2015 - 18:04 Uhr
Sprache: Deutsch
News-ID 385696
Anzahl Zeichen: 13162
contact information:
Town:
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Kategorie:
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