SOPHIA ANTIPOLIS, FRANCE--(Marketwire - May 10, 2012) -
PRESS RELEASE
www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today reports financial results for the
first three months of 2012 and provides an overview of its activities.
"NicOx made good progress during the first quarter of 2012, which was marked
by
the Company's first step towards building an international ophthalmology
company
and by Bausch + Lomb's decision to progress BOL-303259-X into phase 3, which
supports the potential of our R&D platform in ophthalmology," said Michele
Garufi, Chairman and CEO of NicOx. "If we decide to exercise the option to
acquire Altacor, NicOx would benefit from an experienced sales infrastructure
in
the UK with a range of marketed products and from ALT-005 and SOLO potential
to
drive future international growth. We are in advanced discussions with a
number
of parties to secure additional acquisition and in-licensing deals to build a
diversified, late-stage ophthalmic portfolio with a clear route to
commercialisation in the major markets."
Eric Castaldi, Chief Financial Officer of NicOx, commented: "The $10 million
milestone payment from Bausch + Lomb led to a significant increase in our
revenues for the first quarter of 2012. We will continue to carefully monitor
our expenses and ensure the best strategic use of our cash as we transform
NicOx
into an ophthalmology company."
Key highlights for the first quarter of 2012
NicOx building an international late-stage development and commercial
Ophthalmology Company
The Company believes there are a number of opportunities in the growing
ophthalmology market to create a mid-sized, international specialist
pharmaceutical company. NicOx's goal is to build a diversified late-stage
ophthalmology portfolio with a clear route to market, based around
therapeutics,
diagnostics and devices. To this aim, a number of opportunities are currently
under discussion and could lead to additional acquisitions or in-licensing.
Initial investment in Altacor with option to acquire the whole Company
In March 2012, NicOx acquired 11.8% of the shares of Altacor, a privately-held
ophthalmology company based in the United Kingdom. Altacor markets
Clinitas™,
a range of five products for dry eye, in the UK and Ireland. Altacor also has
two promising late-stage candidates, ALT-005 and SOLO. NicOx has an exclusive
option to acquire the remaining shares of Altacor which may be exercised up
until May 31, 2012.
Bausch + Lomb to move into phase 3 following positive phase 2b results
The phase 2b study conducted by Bausch + Lomb with BOL-303259-X (NCX 116) in
patients with open-angle glaucoma or ocular hypertension met its primary
endpoint and showed promising results on a number of secondary endpoints.
Bausch
+ Lomb will initiate a global phase 3 development program for BOL-303259-X and
paid a $10 million milestone payment to NicOx (EUR7.5 million) in April 2012.
BOL-303259-X is a novel nitric oxide-donating prostaglandin F2 alpha analog
licensed
by NicOx to Bausch + Lomb in March 2010.
Appointment of Jerry St. Peter as Executive Vice President and General Manager
of NicOx Inc., the U.S. subsidiary of NicOx
In close collaboration with NicOx's European headquarters, Jerry St. Peter is
responsible for identifying and evaluating opportunities in North America that
can be exploited globally, as part of the Company's strategy to build a late-
stage ophthalmic portfolio. Mr. St. Peter will also lead the development of
NicOx's U.S. ophthalmology business.
Post-first quarter events 2012
Appointment of Philippe Masquida as Executive Vice President, Managing
Director
of European Operations
Mr. Masquida will lead NicOx's operations in Europe and will manage the
Company's European subsidiaries in ophthalmology. He is also responsible, in
coordination with the other members of the executive team of NicOx, for
identifying and evaluating commercial opportunities in Europe.
Meeting with the United States Food and Drug Administration (FDA) on April
3, 2012
NicOx met the FDA to discuss the proposed use of naproxcinod 375 mg twice
daily
(bid), for the treatment of signs and symptoms of osteoarthritis of the knee,
under a proposed New Drug Application (NDA) that would require additional
clinical data prior to any such NDA submission. NicOx is assessing the
requirements for further clinical data discussed with the FDA and its impact
on
the overall development program of naproxcinod. NicOx intends to seek a
partner
to fund and manage any further development and potential commercialization of
naproxcinod.
Financial summary
Revenues were EUR7.5 million in the first quarter of 2012, compared to zero
revenue for the corresponding period of 2011. This significant increase is due
to a one-off $10 million milestone payment (corresponding to EUR7.5 million)
from
Bausch + Lomb, invoiced in March 2012 and paid in April 2012, following Bausch
+Lomb's decision to continue the development of BOL-303259-X.
Research and development costs and administrative and selling costs were
EUR3.8
million in the first quarter of 2012, compared to EUR4.2 million in the first
quarter of 2011.
As a result, NicOx recorded a total net profit of EUR4.2 million in the first
quarter of 2012, compared to a net loss of EUR4.1 million for the same period
in
2011. On March 31, 2012, the Group had cash and cash equivalents totaling
EUR86.8 million (including EUR2.9 million from Altacor and excluding the $10
million
milestone payment paid by Bausch + Lomb in April 2012), compared to EUR93.1
million on December 31, 2011.
Review of the consolidated financial results for the three months ended March
31, 2012 and 2011
The interim consolidated financial statements for the three months ended March
31, 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
in
shares and/or warrants, cash or a combination of cash and shares.
To date, NicOx does not legally control, or have any control over the
financial
and operating policies of Altacor based on its present legal ownership
interests. However, as required by IAS 27, when determining whether NicOx
controlled Altacor, potential voting rights have also been considered. Indeed,
under IAS 27, the Group is deemed to have the power to control Altacor as it
has, currently and until May 31, 2012, the option to acquire the remainder of
Altacor's shares in cash. Therefore, on March 31, 2012 Altacor's transaction
has
been considered as a business combination in accordance with the above
mentioned
accountancy rules.
In this context, NicOx has accounted for the combination of NicOx and Altacor
using the purchase method of accounting in accordance with IFRS 3, 'Business
Combinations'. Results of operations for Altacor have been consolidated in the
Group's income statement for the period March 21, 2012 to March 31, 2012 (8
days
of activity). As a result, the application of IAS 27 has not generated any
significant impact on the consolidated statement of comprehensive income for
the
three month period ended March 31, 2012 but has impacted the consolidated
statement of financial position of NicOx as described below.
Consolidated statement of comprehensive income
Revenues
NicOx revenues totaled EUR7.5 million for the first three months ended March
31, 2012 compared to zero revenue for the same period of 2011.
The revenues recognized during the first quarter of 2012 correspond to the
milestone payment of $10 million invoiced to Bausch + Lomb in March 2012,
following their decision to continue the development of BOL-303259-X (NCX
116).
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.
Research and development costs, administrative and selling costs
Research and development costs, administrative and selling costs for the first
quarter of 2012 decreased to EUR3.8 million compared to EUR4.2 million for the
first
quarter of 2011. In 2010 and in 2011, NicOx implemented two consecutive
restructurings of its entities and activities. As part of the restructuring in
2010, the US offices of NicOx were closed in August 2010, the headcount of the
French and Italian entities of the Group were significantly reduced and
activities were redefined in order to protect the Company's cash and cash
equivalents and refocus the Group's key strategic priorities. In the last
quarter of 2011, the Group has implemented an additional reduction of its
workforce by approximately one third in order to align its structure with the
corporate strategy of creating a commercially-focused development
organization.
On March 31, 2012, 35% of these expenses concerned research and development
expenses and 65% administrative and selling expenses, compared to 66% and 34%,
respectively, in the first quarter of 2011.
During the first quarter of 2012, research and development expenses were
EUR1.3
million, compared to EUR2.8 million during the first three months of 2011. In
the
first quarter of 2012, research and development expenses primarily related to
activities at the research center and ongoing regulatory activities for
naproxcinod. On March 31, 2012, the Group employed 23 people in research and
development, compared to 41 people at the same date in 2011.
Administrative expenses were EUR0.9 million in the first quarter of 2012
compared
to EUR1.0 million in the first quarter of 2011 and include personnel expenses
in
administrative and financial functions, as well as the remuneration of
corporate
officers. Selling expenses totaled EUR1.6 million during the first three
months
ended March 31, 2012 compared to EUR0.4 million during the same period in
2011,
and correspond for 2012 to communication and business development activities
(including notably EUR0.9 million of costs incurred over the period in
relation
with the acquisition of the 11.8% of Altacor). The Group employed 17 people in
its selling and administrative departments on March 31, 2012, compared to 16
people on March 31, 2011.
Other income
During the first quarter of 2012, other income was EUR0.2 million compared to
EUR0.3
million in the first quarter of 2011. Other income corresponds to the
operational subsidies from the research tax credit in France.
Other expense
Other expense, which refers exclusively to restructuring costs, was an income
of
EUR0.2 million in the first quarter of 2012, compared to an expense of EUR0.3
million on March 31, 2011. The income at March 31, 2012, is due principally to
the cancellation of contingencies related to the restructuring of NicOx S.A.
previously recognized in 2010 and 2011, which are no longer applicable in
2012.
Operating profit
On March 31, 2012 the Group generated an operating profit of EUR4.0 million,
compared to an operating loss of EUR4.2 million in the first quarter of 2011.
Other results
Net financial income totaled EUR0.1 million in the first quarter of 2012,
compared
to EUR0.2 million during the same period in 2011, and mainly represents the
returns on the financial investments of the Company's cash and cash
equivalents.
The income tax expense incurred by NicOx during the first three months of 2012
relates to tax from its Italian subsidiary and totaled EUR0.01 million,
compared
to EUR0.05 million on March 31, 2011.
Total net profit for the period
For the first three months ended March 31, 2012, NicOx recorded a net profit
of
EUR4.2 million compared to a net loss of EUR4.1 million during the same period
in
2011. This situation is explained by the strong increase of the revenues
recognized over the period as indicated above.
Consolidated statement of financial position
The indebtedness incurred by NicOx is mainly short-term operating debt. On
March
31, 2012, the Group's current liabilities totaled EUR4.6 million, including
EUR1.9
million in accounts payable to suppliers and external collaborators,
EUR1.1 million in other contingencies and liabilities with respect to the
restructuring cost accrued, EUR1.1 million in taxes payable, EUR0.4 million in
accrued compensation for employees, and EUR0.1 million for other liabilities.
On March 31, 2012, the Group's cash and cash equivalents were EUR86.8 million
(including EUR2.9 million from Altacor), compared to EUR93.1 million on
December
31, 2011.
Following the application of IFRS3 and the consequential consolidation of
Altacor, NicOx elected to measure the non-controlling interest in Altacor at
the
proportionate share of its interest in Altacor's identifiable assets and
recognized a goodwill of EUR2.0 million on March 21, 2012. This amount of
goodwill
has been determined provisionally and will be adjusted before the end of the
twelve month period following the potential acquisition. In the event of a
successful completion of the acquisition of the remaining shares of Altacor,
the
difference between the consideration paid and the carrying value of the
interests acquired in Altacor will not be accounted for by an increase in
goodwill, but recognized into equity.
About NicOx
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is building an international
late-stage development and commercial Ophthalmology Company based around
therapeutics, diagnostics and devices. As of March 2012, NicOx holds an 11.8%
stake in the UK-based ophthalmology company Altacor, with an option to acquire
the remaining shares, as the first step of a transformation into a late-stage
development and commercial ophthalmic Company.
NicOx is also developing an internal portfolio of New Molecular Entities
(NMEs)
through the application of its proprietary nitric oxide-donating R&D platform.
The Company's pipeline includes several nitric oxide-donating NMEs for the
potential treatment of ophthalmological, inflammatory and cardio-metabolic
diseases, which are in development internally and with partners, who include
Bausch + Lomb, 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).
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 - March 31, 2012
-----------------------------------------
For the period of three months ended
March 31,
-----------------------------------------
2012 2011
-----------------------------------------
(in thousands of EUR except for share data)
-----------------------------------------
Revenues 7,487 -
Research & development expenses (1,346) (2,774)
Administrative expenses (929) (1,037)
Selling expenses (1,563) (423)
Other income 160 320
Other expense 234 (255)
Operating profit (loss) 4,043 (4,169)
Finance income 174 173
Finance expense (36) (12)
Profit (loss) before income tax 4,181 (4,008)
Income tax expense (14) (52)
------------ ------------
Net profit (loss) 4,167 (4,060)
============ ============
Exchange differences on
translation of foreign
operations (9) 34
------------ ------------
Other comprehensive income (loss)
for the period, net of tax (9) 34
============ ============
------------ ------------
Total comprehensive income (loss)
for the period, net of tax 4,158 (4,026)
============ ============
Attributable to:
Equity holders of the parent 4,174 (4,026)
Non controlling interests (16)
Interim consolidated Statement of Financial Position - March 31, 2012
As of March 31, As of March 31,
2012 2011
(in thousands of EUR)
-----------------------------------------
ASSETS
Non-current assets
Property, plant & equipment 714 843
Goodwill 2,022 -
Intangible assets 94 117
Other financial assets 260 263
Deferred income tax assets 69 65
------------ ------------
Total non-current assets 3,159 1,288
------------ ------------
Current assets
Stock 218 -
Trade receivables 7,683 -
Government subsidies receivable 1,242 866
Other current assets 932 367
Prepaid expenses 545 172
Cash and cash equivalents 86,834 93,136
------------ ------------
Total current assets 97,454 94,541
------------ ------------
============ ============
TOTAL ASSETS 100,613 95,829
============ ============
EQUITY AND LIABILITIES
Common shares 14,578 14,563
Other reserves 73,960 69,761
Non-controlling interests 2,821 -
------------ ------------
Total Equity 91,359 84,324
------------ ------------
Non-current liabilities
Other contingencies and liabilities 4,593 4,592
Deferred income tax liabilities 3 3
Finance lease 58 58
------------ ------------
Total non-current liabilities 4,654 4,653
------------ ------------
Current liabilities
Other contingencies and liabilities 1,057 3,590
Finance lease 19 24
Trade payables 1,947 1,185
Current income tax payable 0 -
Social security and other taxes 1,513 1,890
Other liabilities 64 163
------------ ------------
Total current liabilities 4,600 6,852
------------ ------------
============ ============
TOTAL EQUITY AND LIABILITIES 100,613 95,829
============ ============
NicOx reports first quarter 2012 financial results:
http://hugin.info/143509/R/1610672/511998.pdf
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originality of the information contained therein.
Source: NICOX via Thomson Reuters ONE
[HUG#1610672]
