SOPHIA ANTIPOLIS, FRANCE--(Marketwire - Oct 25, 2012) - Nicox S.A. (NYSE Euronext Paris: COX) today reported financial results for the nine month period ended
September 30, 2012, and provided an overview of its activities.
Third quarter operational summary
Following the completion of the worldwide in-licensing agreement in June
2012
with Rapid Pathogen Screening, Inc (RPS®) for several innovative
diagnostic
tests, including AdenoPlus™, Nicox has been building up its commercial
organization in the United States (US) and in Europe. In August 2012, Nicox
strengthened its US business operations with the appointment of Jason Menzo
as
Director of Marketing, Mark Puwal as National Director of Sales and Jason
Werner
as Director of Commercial Development & Strategic Alliances for Nicox Inc.,
its
US subsidiary. These followed the appointment of Jerry St. Peter as
Executive
Vice President and General Manager of Nicox Inc. in March 2012 and Philippe
Masquida as Executive Vice-President, Managing Director of European
Operations
in April 2012.
In August 2012, Nicox Pharma, a new subsidiary, was created. Its purpose is
to
organize the Group's global commercial activities outside of North America.
In
September 2012, certain rights related to the diagnostic tests in-licensed
from
RPS® were sub-licensed to Nicox Inc. for the US and Canada and to
Nicox Pharma
for the rest of the world.
Post-reporting period
In October 2012, Nicox launched its first commercial product,
AdenoPlus™, in
the US. AdenoPlus™ is the first and only FDA-cleared, CLIA-waived, rapid
point-of-care diagnostic test that aids in the differential diagnosis of
acute
conjunctivitis. The Company also unveiled a new brand identity representing
its
new positioning as an international late-stage development and commercial
ophthalmic group.
In line with its strategic positioning, Nicox has decided to refocus the
activities of its Italian research subsidiary Nicox Srl on the ophthalmic
space.
A small, specialized team will pursue targeted projects in collaboration
with
external research centers. This will enable Nicox to enhance its knowledge
of
the role and potential of nitric oxide (NO) in the eye and to leverage its
long-
standing expertise in the therapeutic application of NO-donating compounds.
Michele Garufi, Chairman and CEO of Nicox, commented: "During the quarter
we
have made good progress in our strategy to become a new commercial player
in the
ophthalmic space. We recently built a specialized sales team in the US and
launched our first commercial product in this market. We continue to
evaluate
additional ophthalmic assets to fully leverage our new commercial structure
and
create a portfolio of products for the US and as well for the future
European
operations. Our Research Centre in Milano will continue the activities
around
our second generation of NO-donating compounds to build on their potential
for
the development of new ophthalmic therapies."
Financial summary for the first nine months of 2012
Revenues were EUR7.6 million in the nine months to September 30, 2012,
compared to
zero for the corresponding period of 2011. These revenues correspond
principally
to a one-off $10 million milestone payment received from Bausch + Lomb in
April
2012, following its decision to continue the development of BOL-303259-X.
Research and development costs and administrative and selling costs were
EUR11.6 million in the nine months to September 30, 2012, compared to
EUR11.8
million in the same period in 2011.
Nicox recorded a total net loss of EUR4.6 million in the period of nine
month
ending on September 30, 2012, compared to a net loss of EUR10.4 million for
the
same period in 2011. On September 30, 2012, the Group had cash and cash
equivalents totaling EUR81.8 million, compared to EUR93.1 million on
December
31, 2011.
Review of the consolidated financial results for the nine months ended
September
30, 2012 and 2011
The interim consolidated financial statements for the nine months ended
September 30, 2012 and 2011 have been prepared in accordance with
applicable
IFRS principles.
On March 21, 2012, Nicox acquired 11.8% of the shares of Altacor, a
privately-
held ophthalmology company based in the United Kingdom, and, further,
entered
into an exclusive option agreement to acquire the remaining shares of
Altacor.
On May 31, 2012 Nicox decided not to exercise the option to acquire the
remaining 88.2 % of equity of Altacor. Under IFRS principles the Group is
deemed
to exercise a significant influence over Altacor as a result of its
participation in the share capital and Board of Directors of Altacor.
Consequently, the presented consolidated financial statements for the nine
months to September 30, 2012 include Altacor for the period from May 31 to
September 30, 2012, on the basis of the equity method.
Consolidated statement of comprehensive income
Revenues
Nicox revenues totalled EUR7.6 million for the nine months ended September
30, 2012, compared to zero revenue in the same period of 2011.
The revenues recognized on September 30, 2012, correspond principally to
the
milestone payment of $10 million received from Bausch + Lomb in April 2012,
following their decision to continue the development of BOL-303259-X. This
amount has been immediately recognized in revenues because the Company will
not
have continuing involvement in the future development of this compound,
which is
the subject of the collaboration agreement signed in 2010 with Bausch +
Lomb.
The revenues also include the sales of AdenoPlus™ (EUR0.02 million) made
by
RPS® on behalf of Nicox from July 1st, 2012 to September 30, 2012
following the
signature of the licensing agreement with RPS® in June 2012. In the
third
quarter of 2012, RPS® has taken AdenoPlus™ orders for Nicox. Nicox
initiated
its own active marketing activities in October 2012.
Cost of goods sold
This item corresponds to the cost of goods sold in relation with the above
mentioned sales of AdenoPlus™ by RPS® and includes all the direct
costs
related to the manufacturing of the products sold.
Research and development costs, administrative and selling costs
For the nine months ended September 30, 2012, research and development
costs,
administrative and selling costs amounted to EUR11.6 million compared to
EUR11.8
million for the same period of 2011. On September 30, 2012, 39% of these
expenses concerned research and development expenses and 61% administrative
and
selling expenses, compared to 61% and 39%, respectively, on September 30,
2011.
This situation is explained by the ongoing transformation of Nicox into a
commercial ophthalmic company.
For the first nine months of 2012, research and development expenses were
EUR4.5
million, compared to EUR7.2 million during the same period in 2011. In the
nine
months ended September 30, 2012, research and development expenses
primarily
related to activities at the research centre and ongoing regulatory
activities
for naproxcinod. The Group employed 18 people in research and development
on
September 30, 2012, compared to 39 people at the same date in 2011.
Administrative expenses were EUR3.1 million on September 30, 2012, compared
to
EUR3.4 million at the same date in 2011 and include personnel expenses in
administrative and financial functions, as well as the remuneration of
corporate
officers. On September 30, 2012, the Group employed 11 people in its
administrative department, compared to 14 people on September 30, 2011.
In the first nine months of 2012, selling expenses totalled EUR4 million
compared
to EUR1.3 million during the same period in 2011. Selling expenses
correspond for
the first nine months of 2012 to communication and business development
activities (including EUR0.7 million of costs incurred over the period in
relation
to the acquisition of 11.8% of Altacor), and also include the costs of
building
Nicox's commercial organization in the US and in Europe following the
recent in-
licensing of AdenoPlus™. On September 30, 2012, the Group employed 9
people
in its selling department (commercial and corporate development), compared
to 4
people on September 30, 2011.
Other income
On September 30, 2012, other income was EUR0.6 million compared to EUR0.8
million in
the first nine months of 2011. In 2012, other income includes EUR0.3
million of
operational subsidies from the research tax credit in France and EUR0.3
million of
unrealized foreign exchange gains.
Other expense
Other expense, which refers exclusively to restructuring costs, amounted to
EUR0.5
million for the nine months ended September 30, 2012, compared to an income
of
EUR0.1 million on September 30, 2011. On September 30, 2012, the Group has
accrued
an amount of EUR0.9 million with respect to an undertaking vis-à-vis
employees of
the Italian subsidiary in the event of a potential further restructuring.
Operating loss
The Group generated an operating loss of EUR4 million in the first nine
months of
2012, compared to EUR10.9 million during the same period in 2011.
Other results
In the first nine months of 2012, the Group recorded a net financial loss
of
EUR0.6 million (including the share of Altacor's results), compared to a
net
financial income of EUR0.7 million during the first nine months of 2011. On
September 30, 2012, finance expenses include the depreciation of the non-
refundable part of the option fee paid to RPS® in June 2012 to
negotiate an
agreement for an additional product. Said depreciation has been booked due
to
the fact that the product is still under development.
The income tax expense incurred by Nicox on September 30, 2012, relates to
tax
from its Italian subsidiary and totalled EUR0.03 million, compared to
EUR0.09
million on September 30, 2011.
Total net loss for the period
Nicox recorded a net loss of EUR4.6 million on September 30, 2012, compared
to
EUR10.4 million on September 30, 2011. This significant decrease of the net
loss
in the first nine months of 2012 is explained by the strong increase in
revenues
recognized over the period as indicated above.
Consolidated statement of financial position
The intangible assets includes EUR1.6 million corresponding to the license
fee
paid to RPS® for the worldwide licensing agreement on three diagnostic
tests
signed in June 2012.
The indebtedness incurred by Nicox is mainly short-term operating debt. On
September 30, 2012, the Group's current liabilities totalled EUR5.8
million,
including EUR2 million in accrued compensation for employees, EUR1.5
million in
accounts payable to suppliers and external collaborators, EUR1.4 million in
other
contingencies and liabilities with respect to the restructuring cost
accrued,
EUR0.8 million in taxes payable and EUR0.1 million in other liabilities.
On September 30, 2012, the Group's cash and cash equivalents were EUR81.8
million,
compared to EUR93.1 million on December 31, 2011.
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating an international,
late-
stage development and commercial ophthalmic group based around
therapeutics,
diagnostics and
devices.
Nicox has inlicensed innovative ocular diagnostics from RPS®,
including
AdenoPlus™, a test for the detection of adenoviral conjunctivitis
already
authorized for marketing in the United States and Europe. The Company
has a
partnership with Bausch + Lomb for the development of BOL303259X, a
novel
glaucoma candidate based on Nicox's proprietary nitric oxide-
donating R&D
platform.
Further nitric oxide-donating compounds are under development in non-
ophthalmic
indications notably through partners, including Merck (known as MSD
outside the
United States and Canada) and
Ferrer.
Nicox S.A. is headquartered in France and is listed on Euronext
Paris
(Compartment C: Small Caps). For more information please visit
www.nicox.com.
This press release contains certain forward-looking statements. Although
the
Company believes its expectations are based on reasonable assumptions,
these
forward-looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those
anticipated in
the forward-looking statements.
Risks factors which are likely to have a material effect on Nicox's
business are
presented in the 4th chapter of the « Document de référence,
rapport financier
annuel et rapport de gestion 2011 » filed with the French
Autorité des Marchés
Financiers (AMF) on February 29, 2012 and available on Nicox's website
(www.nicox.com) and on the AMF's website www.amf-france.org).
Interim consolidated statement of Comprehensive Income - september 30,
2012
-------------------
For the period of
nine months ended
September 30,
2012 2011
-------------------
(in thousands of EUR
except for per
share data)
-------------------
Revenues 7,571 -
Cost of goods sold (6) -
Research and development expenses (4,518) (7,160)
Administrative expenses (3,105) (3,395)
Selling expenses (4,007) (1,279)
Other income 622 764
Other expense (542) 141
Operating (3,985) (10,929)
loss
Finance income 403 675
Finance expenses (847) (12)
Share of Profit (loss) of associates (169) -
Loss before income (4,598) (10,266)
tax
Income tax expense (32) (94)
-------------------
Net loss of the period (4,630) (10,360)
-------------------
Exchange differences on translation of foreign
operations 3 -
Other comprehensive income (loss) for the period,
net of tax 3 -
-------------------
Total comprehensive income (loss) for the period,
net of tax (4,627) (10,360)
-------------------
Attributable to:
- Equity holders of the parent 4,627 10,360
- Non-controlling interests - -
-------------------
Basic and diluted loss per share attributable to
equity holders of the parent (0,06) (0.14)
-------------------
Interim consolidated Statement of Financial Position - september 30,
2012
------------------------------------
As of September As of December
30, 31,
2012 2011
------------------------------------
(in thousands of EUR)
------------------------------------
ASSETS
Non-current assets
Property, plant & equipment................ 651 843
Intangible assets ................... 1,672 117
Investments in associates and joint
ventures..... 2,243 -
Other financial assets ................. 1,116 263
Deferred income tax assets............ 67 65
------------------------------------
Total non-current assets................ 5,749 1,288
------------------------------------
Current assets
Government subsidies
receivable.........................
........... 1,199 866
Other current assets............... 1,541 367
Prepaid expenses.............. 243 172
Cash and cash equivalents............ 81,757 93,136
------------------------------------
Total current assets................... 84,740 94,541
------------------------------------
------------------------------------
TOTAL ASSETS.................. 90,489 95,829
------------------------------------
EQUITY AND LIABILITIES
Common shares..................... 14,579 14,563
Other reserves................. 65,408 69,761
Non-controlling interests................ - -
------------------------------------
Total Equity.................. 79,987 84,324
------------------------------------
Non-current liabilities
Other contingencies and liabilities........ 4,655 4,592
Deferred income tax liabilities....... (17) 3
Finance lease................ 58 58
------------------------------------
Total non-current liabilities........ 4,696 4,653
------------------------------------
Current liabilities
Other contingencies and liabilities........ 1,360 3,590
Finance lease................ 65 24
Trade payables.............. 1,452 1,185
Social security and other taxes....... 2,814 1,890
Other liabilities............. 115 163
------------------------------------
Total current liabilities........... 5,806 6,852
------------------------------------
------------------------------------
TOTAL EQUITY AND LIABILITIES....... 90,489 95,829
------------------------------------
Nicox reports financial results for the nine months to September 2012:
http://hugin.info/143509/R/1652076/533153.pdf
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Source: NICOX via Thomson Reuters ONE
[HUG#1652076]