Nicox S.A. (NYSE Euronext Paris: COX) today announced its financial results for
the nine month period ended September 30, 2013, and provided an update of its
activities.
Michele Garufi, Chairman and CEO of Nicox, said: "In the third quarter of 2013
we made progress in strengthening our commercial organization in the five
largest European markets, where we plan to launch AdenoPlus(®), our first
diagnostic test in-licensed from RPS(®), as well as a line of eye care products
sourced from a European partner.
We also made good progress in the United States, where we are preparing to
launch our second diagnostic test by the end of 2013, the innovative Dry Eye
Panel for Sjögren's Syndrome, further to our exclusive agreement with Immco
Diagnostics Inc.
In addition, we received Orphan Drug Designation in Europe for naproxcinod for
the treatment of Duchenne Muscular Dystrophy. This designation will support our
search for specialized financial or pharma partners interested in undertaking
and funding the development of our drug in this severe genetic disease, which
still lacks any approved drug treatment."
Third quarter operational summary
During the third quarter of 2013, Nicox continued building its ophthalmology-
focused commercial organization both in the United States and in the five major
European markets: France, Italy, United Kingdom, Germany and Spain. Nicox
continues to evaluate in-licensing and acquisition opportunities in these
markets to fully leverage this sales infrastructure.
In July 2013, Bausch + Lomb initiated clinical studies in Japan for
latanaprostene bunod, a nitric oxide (NO)-donating prostaglandin F2-alpha
analog, currently in Phase 3 clinical development for the potential treatment of
glaucoma and ocular hypertension.
During the third quarter of 2013, Bausch + Lomb decided to waive its option to
develop additional preclinical NO-donating compounds. Bausch + Lomb remains
fully committed to the development of latanaprostene bunod.
In September 2013, Nicox and Grupo Ferrer Internacional S.A. ("Ferrer"), a
subsidiary of Ferrer Grupo, have agreed to terminate the option agreement they
had entered into in March 2011. This agreement granted Ferrer an option on co-
marketing rights for naproxcinod in Spain and Germany, and on exclusive
marketing rights in Greece and Portugal.
Post-reporting period
In October 2013, the European Commission granted Orphan Drug Designation (ODD)
for naproxcinod, a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-
inflammatory candidate, for the treatment of Duchenne Muscular Dystrophy (DMD).
A positive opinion had been issued by the Committee for Orphan Medicinal
Products (COMP) in September 2013. Promising preclinical results obtained with
naproxcinod in models of muscular dystrophy were presented at the Muscular
Dystrophy Association Scientific Conference in Washington, DC in April 2013, and
at the International Congress of the World Muscle Society in Asilomar, CA in
October 2013.
In October 2013, Nicox decided not to exercise the option to negotiate an
agreement for an additional diagnostic test included in the licensing agreement
signed with Rapid Pathogen Screening, Inc. (RPS(®)) in June 2012. As a result,
Nicox recovered $1 million (approximately €0.74 million) corresponding to the
refundable part of the option fee.
Financial summary for the first nine months of 2013
Revenues were €0.3 million in the nine months to September 30, 2013, compared to
€7.6 million for the corresponding period of 2012, which included a milestone
payment from Bausch + Lomb.
Selling, administrative and research and development costs were €13.6 million in
the first nine months of 2013, with 43% of these costs related to selling
expenses, reflecting the transformation of Nicox into a commercial ophthalmic
company. This compares to €11.6 million for the same period in 2012.
Nicox recorded a total net loss of €13.6 million in the period of nine months
ending on September 30, 2013, compared to a net loss of €4.6 million for the
same period in 2012. On September 30, 2013, the Group had cash and cash
equivalents totaling €63.8 million, compared to €77.5 million on December
31, 2012.
Review of the consolidated financial results as of September 30, 2013 and 2012
The consolidated financial statements for the nine months to September 30, 2012
include Altacor (a privately-held ophthalmology company in which Nicox acquired
in March 2012 11.8% of the shares) for the period from May 31 to September
30, 2012, on the basis of the equity method.
Consolidated statement of comprehensive income
Revenues
Nicox's revenues amounted to €0.3 million for the nine months ended September
30, 2013, compared to €7.6 million for the same period of 2012.
Revenues recognized on September 30, 2013 correspond to the sales of
AdenoPlus(®), a diagnostic test in-licensed from Rapid Pathogen Screening, Inc
(RPS(®)) in June 2012. Nicox initiated its own marketing activities for
AdenoPlus(®) in the US in October 2012 and is in the process of strengthening
its internal sales force to support the upcoming launch of the Dry Eye Panel for
Sjögren's Syndrome. AdenoPlus(®) is already CE-marked and available and Nicox is
preparing to launch the product, with its own sales force, in the top five
European markets.
The revenues recognized in the first nine months of 2012 correspond to the
milestone payment of $10 million received from Bausch + Lomb in April 2012,
following their decision to continue the development of latanoprostene bunod.
Cost of sales
Cost of sales amounted to €0.3 million during the first nine months of 2013.
This item corresponds to the cost of goods sold in relation to the sales of
AdenoPlus(®) and includes all the costs related to the manufacturing of the
products sold.
Selling, administrative and research and development costs
Selling, administrative and research and development expenses were €13.6 million
in the first nine months of 2013 compared to €11.6 million for the same period
of 2012. On September 30, 2013, 43% of these costs were related to selling
expenses, 37% to administrative expenses (including the corporate development
expenses previously reported as selling expenses) and 20% to research and
development expenses. This compared to 9% related to selling expenses, 52% to
administrative expenses (including the corporate development expenses previously
reported as selling expenses), and 39% to research and development expenses, on
September 30, 2012. The change reflects the ongoing transformation of Nicox into
a commercial ophthalmic company.
For the first nine months ended September 30, 2013, selling expenses were €5.8
million, compared to €1.1 million in the first nine months of 2012. Selling
expenses correspond to the costs of building Nicox's commercial organization in
the US and in Europe to support the planned business activities related to our
current portfolio and to future products we expect to add to our pipeline. The
Group employed 21 people in its sales and marketing department on September
30, 2013 compared with 5 people on September 30, 2012.
During the period, administrative expenses amounted to €5.0 million, compared to
€6.1 million in the first nine months of 2012, and include personnel expenses in
administrative and financial functions, as well as the remuneration of corporate
officers, and since 2012, communication and business development expenses which
were previously reported in selling expenses. Administrative expenses for the
first nine months of 2013 are substantially lower than for the same period of
2012 due to the fact that administrative expenses in an amount of €0.7 million
had been recorded in 2012 in relation to the acquisition of 11.8% of Altacor. On
September 30, 2013, the Group employed 14 people in its administrative
department, compared to 15 people at the same date in 2012.
Research and development expenses totaled €2.7 million for the first nine months
ended September 30, 2013, compared to €4.5 million on September 30, 2012. The
Group employed 12 people in research and development on September 30, 2013,
compared to 18 people at the same date in 2012.
Other income
Other income amounted to €0.4 million on September 30, 2013, compared to €0.6
million at the same date in 2012. In the first nine months of 2013, other income
included €0.3 million of operational subsidies from the research tax credit in
France.
Other expense
Other expense was €0.3 million for the first nine months of 2013 and corresponds
mainly to unrealized foreign exchange losses, compared to €0.5 million on
September 30, 2012.
Operating loss
In the first nine months of 2013, the Group generated an operating loss of €13.5
million, compared to an operating loss of €4.0 million during the same period in
2012.
Other results
The Group recorded a net financial loss of €0.07 million in the first nine
months of 2013, compared to €0.6 million (including the share of Altacor's
results) during the same period in 2012. On September 30, 2012, financial
expense include the depreciation of the non-refundable part of the option fee
paid to RPS(®) in June 2012.
On September 30, 2013, the income tax expense incurred by Nicox relates
principally to tax from its Italian subsidiary and amounted to €0.02 million,
compared to €0.03 million at the same date in 2012.
Total net loss for the period
For the nine months ended September 30, 2013, Nicox recorded a net loss of €13.6
million, compared to a net loss of €4.6 million on September 30, 2012. This is
explained by (i) the increase in operating expenses related to the costs of
building Nicox's commercial organization in the US and in Europe, and (ii) by
the strong decrease in revenues recognized over the period compared to the first
nine months of 2012, which included a significant milestone payment from Bausch
+ Lomb as set out above.
Consolidated statement of financial position
Intangible assets totaled €1.9 million at the end of the first nine months of
2013 and included €1.4 million corresponding to the license fee paid to RPS(®)
for the worldwide licensing agreement signed in June 2012.
On September 30, 2013, financial assets amounted to €2.4 million, including €1.4
million representing the fair value of the shares held by Nicox in Altacor, €0.8
million corresponding to the re-fundable part of the option fee paid to RPS(®)
in June 2012, and €0.2 million of security deposits.
The indebtedness incurred by Nicox is mainly short-term operating debt. On
September 30, 2013, the Group's current liabilities totaled €3.6 million,
including €1.5 million in accounts payable to suppliers and external
collaborators, €1 million in accrued compensation for employees, €0.8 million in
taxes payable, €0.2 million in other liabilities and €0.1 million in other
contingencies.
On September 30, 2013, the Group's cash and cash equivalents were €63.8 million,
compared to €77.5 million on December 31, 2012.
...................................
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an emerging international company
focused on the ophthalmic market. With a heritage of innovative R&D, business
development and commercial expertise, the Nicox team is building a diversified
portfolio of therapies and diagnostic tools that can help people to enhance
their sight. The Company's commercial portfolio and near-term pipeline already
include several innovative diagnostic tests intended for eye care professionals,
as well as a range of eye care products. Nicox's key proprietary asset in
ophthalmology is latanoprostene bunod, a novel compound based on Nicox's
proprietary nitric oxide (NO)-donating R&D platform, currently in Phase 3
clinical development in collaboration with Bausch + Lomb for the potential
treatment of glaucoma and ocular hypertension. Further NO-donors are under
development, notably through partners.
Nicox is headquartered in France, with research capabilities in Italy, a growing
commercial infrastructure in North America and in the major European markets and
an expanding international presence through partners. Nicox S.A. is listed on
Euronext Paris (Compartment B: Mid Caps). For more information on Nicox or its
products please visit www.nicox.com.
...................................
Nicox S.A.
Drakkar 2 | Bât D | 2405 route des Dolines | CS 10313 | Sophia Antipolis |
06560 Valbonne | France
T: +33 (0)4 97 24 53 00 | F: +33 (0)4 97 24 53 99
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 2012 » filed with the French Autorité des Marchés
Financiers (AMF) on March 22, 2013 and available on Nicox's website
(www.nicox.com) and on the AMF's website (www.amf-france.org).
...................................
Nicox Contacts
Nicox Gavin Spencer | Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00 | communications@nicox.com
Media Relations FTI Consulting
Europe Julia Phillips | D+44 (0)20 7269 7187 | M +44 (0) 7770 827 263
Julia.Phillips@fticonsulting.com
Stephanie Cuthbert | D +44 (0)20 3077 0458 | M +44 (0)
7843 080947
Stephanie.Cuthbert@fticonsulting.com
Mo Noonan | D +44 (0)20 7269 7116 | M +44 (0)7876 444 977
Mo.Noonan@fticonsulting.com
INTERIM CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME - SEPTEMBER 30, 2013
----------------------------------------
For the period of nine months ended
September 30,
----------------------------------------
2013 2012
----------------------------------------
(In thousands of € except for per share
data)
----------------------------------------
Revenues 252 7,571
Cost of sales (339) (6)
Selling expenses (5,782) (1,052)
Administrative expenses (5,032) (6,059)
Research & development expenses (2,738) (4,519)
Other income 435 622
Other expense (340) (542)
Operating profit (loss) (13,544) (3,985)
Financial income 196 403
Financial expense (261) (847)
Share of Profit (loss) of associates - (169)
Profit (Loss) before income tax (13,609) (4,598)
Income tax expense (17) (32)
-------------------------------------------------------------------------------
Net profit (loss) (13,626) (4,630)
-------------------------------------------------------------------------------
Exchange differences on translation of 153 3
foreign operations
Other comprehensive income (loss) 153 3
for the period, net of tax
-------------------------------------------------------------------------------
Total comprehensive income (loss) (13,473) (4,627)
for the period, net of tax
-------------------------------------------------------------------------------
Attributable to:
- Equity holders of the parent (13,473) (4,627)
- Non-controlling interests - -
-------------------------------------------------------------------------------
Basic and diluted loss per share
attributable to equity holders of the (0,18) (0,06)
parent
-------------------------------------------------------------------------------
INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION - SEPTEMBER 30, 2013
---------------------------------------
As of September 30, As of December 31,
2013 2012
---------------------------------------
(In thousands of €)
---------------------------------------
ASSETS
Non-current assets
Property, plant & equipment 622 791
Intangibles assets 1,852 1,801
Financial assets 2,352 2,550
Deferred income tax assets 106 54
---------------------------------------
Total non-current assets 4,932 5,196
---------------------------------------
Current assets
Inventories 65 26
Trade receivables 71 7
Government subsidies receivable 878 531
Other current assets 395 757
Prepaid expenses 310 154
Cash and Cash equivalents 63,783 77,477
---------------------------------------
Total current assets 65,502 78,952
---------------------------------------
---------------------------------------
TOTAL ASSETS 70,434 84,147
---------------------------------------
EQUITY AND LIABILITIES
Common shares 14,593 14,579
Other reserves 47,406 59,975
---------------------------------------
Total Equity 61,999 74,554
---------------------------------------
Non-current liabilities
Other contingencies and liabilities 4,724 4,618
Deferred income tax liabilities 10 8
Financial Lease 120 114
---------------------------------------
Total non current liabilities 4,854 4,740
---------------------------------------
Current liabilities
Other contingencies and liabilities 148 667
Financial lease 52 43
Trade payables 1,520 1,850
Social security and other taxes 1,755 2,145
Other liabilities 106 149
---------------------------------------
Total current liabilities 3,581 4,853
---------------------------------------
---------------------------------------
TOTAL EQUITY AND LIABILITIES 70,434 84,147
---------------------------------------
Nicox reports financial results for the nine months to September 2013: http://hugin.info/143509/R/1739068/583541.pdf
[HUG#1739068]
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