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Nicox: first quarter 2013 financial results


May 15, 2013 - Sophia Antipolis Cedex, France

Nicox S.A. (NYSE EuronextParis: COX) today reports financial results for thefirst three months of 2013 and provides an overview of its activities.

"We are encouraged by the progress made this quarter in growing Nicox as anewinternational ophthalmic company. We entered into an exclusive supply anddistribution agreement for an innovative line of eye care products plannedto belaunched from the end of the year and our partner Bausch + Lomb initiatedthephase 3 programme of the latanoprostene bunod as planned. These twoimportantachievements represent new steps in our plan to create a portfolio oftherapeutics and diagnostics which will support Nicox's expansion in theophthalmic markets of Europe and the United States", said Michele Garufi,ChiefExecutive Officer of Nicox.

First quarter operational summary

In light of the positive results of the phase 2b study conducted withlatanoprostene bunod (previously known as BOL-303259-X and NCX 116), Bausch+Lomb initiated a phase 3 clinical program with latanoprostene bunod inJanuary2013. This pivotal phase 3 program includes two separate, randomized,multicentre, double-masked, parallel-group clinical studies, APOLLO andLUNAR,which will be conducted in North America and Europe. These phase 3 studiesarepivotal for U.S. registration.

In March 2013, Nicox strengthened its European and International Operationsteamwith the appointments of David Trevor as Vice President, Managing DirectorUKand Head of European Sales Force Effectiveness; Davide Buffoni as ManagingDirector, Spain; and François Ducret as Director of InternationalOperations.The team, under the leadership of Philippe Masquida as Executive VicePresident,Managing Director of European and International Operations, will manage thecommercialization of Nicox's ophthalmic products in Europe and otherimportantmarkets around the world outside North America.

Nicox also announced it has entered into an exclusive supply anddistributionagreement with an undisclosed private European pharmaceutical company for arange of eye care products developed for a major therapeutic class with adifferentiated formulation. Nicox expects to launch this family of productsdirectly and through partners from the end of the year onwards. Under thetermsof the agreement, Nicox will have exclusive rights to market, sell anddistribute these products in Europe, Middle East and Africa. The agreementdoesnot provide for any upfront payment from Nicox.

Post-first quarter events 2013

In line with the strategy to transform Nicox into an internationalophthalmologycompany, Nicox's Board of Directors has nominated Vicente Anido, Jr., PhD.,tobe elected to the Board. Dr. Anido is a highly respected and experiencedleaderin the ophthalmology sector. His election to the Company's Board will bevotedon at the 2013 Ordinary Shareholder Meeting, which is convened for June 6,2013.

In areas outside the core ophthalmic field, Nicox and the Center forGeneticMedicine Research, a center within the Children's Research Institute,Children'sNational Medical Center, presented promising pre-clinical results onnaproxcinod, a CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating)anti-inflammatory candidate, in models of muscular dystrophies. The datawerepresented in a poster session on April 22, 2013, at the Muscular DystrophyAssociation (MDA) Scientific Conference in Washington, DC.

Also, in April 2013, Nicox and Ferrer agreed to terminate their nitricoxide-donating steroids collaboration in dermatology, including terminationof theResearch & Development, Licence and Option Agreement of April 28, 2004.Nicoxdoes not intend to continue the development of nitric oxide-donatingsteroids indermatology nor seek another partner in this area.

Financial summary

For the three months ended March 31, 2013, Nicox's revenues totaled EUR0.07million, compared to EUR7.5 million for the same period of 2012, whichincludedreceipt of a significant milestone payment from Bausch + Lomb.

Research and development costs and administrative and selling costsamounted toEUR4.3 million in the first quarter of 2013 compared to EUR3.8 million inthe firstquarter of 2012.

As a result, Nicox recorded a net loss of EUR4.3 million for the threemonthsended March 31, 2013, compared to a net profit of EUR4.2 million for thethreemonths to March 31, 2012. On March 31, 2013, the Group's cash and cashequivalents were EUR72.1 million, compared to EUR77.5 million on December31, 2012.

Review of the consolidated financial results as of March 31, 2013 and 2012

Consolidated statement of comprehensive income

Revenues

For the three months ended March 31, 2013, Nicox's revenues totaled EUR0.07million, compared to EUR7.5 million for the same period of 2012.

Revenues of the first quarter of 2013 correspond to initial sales ofAdenoPlus®,a rapid point-of-care diagnostic test in-licensed from Rapid PathogenScreening,Inc (RPS®) in June 2012. Nicox initiated its own marketing activitiesforAdenoPlus® in October 2012 and is in the process of building up asales networkto support the product.

The revenues recognized in the first quarter of 2012 correspond to themilestonepayment of $10 million received from Bausch + Lomb in April 2012, followingtheir decision to continue the development of latanoprostene bunod(previouslyknown as BOL-303259-X).

Cost of sales

Cost of sales amounted to EUR0.09 million during the first quarter of 2013.Thisitem corresponds to the cost of goods sold in relation to the abovementionedsales of AdenoPlus® and includes all the costs related to themanufacturing ofthe products sold.

Research and development costs, administrative and selling costs

Research and development costs and administrative and selling costsamounted toEUR4.3 million in the first quarter of 2013 compared to EUR3.8 million inthe firstquarter of 2012. In the first three months of 2013, 22% of these costs wererelated to research and development expenses, 40% to administrativeexpenses(including the corporate development expenses previously reported assellingexpenses) and 38% to selling expenses. This compared to 35% related toresearchand development expenses and 65% to administrative expenses (including thecorporate development expenses previously reported as selling expenses) inthefirst quarter of 2012. The change reflects the ongoing transformation ofNicoxinto a commercial ophthalmic company.

Research and development expenses were EUR1million for the first threemonthsended March 31, 2013, compared to EUR1.3 million in the first three monthsof2012. In the first quarter of 2013, research and development expenses wereprincipally related to activities at the research center and ongoingregulatoryactivities for naproxcinod. On March 31, 2013, the Group employed 14 peopleinresearch and development, compared to 23 people at the same date in 2012.

For the first three months of 2013, administrative expenses were EUR1.7million,compared to EUR2.5 million in the first quarter of 2012, and includepersonnelexpenses in administrative and financial functions, as well as theremunerationof corporate officers, and since 2012, communication and businessdevelopmentexpenses which were previously reported in selling expenses. Administrativeexpenses for the first quarter of 2013 are substantially lower than for thesameperiod of 2012 due to the fact that administrative expenses in an amount ofEUR0.7million had been recorded in 2012 in relation to the acquisition of 11.8%ofAltacor, a privately-held ophthalmology company based in the UnitedKingdom. OnMarch 31, 2013, the Group employed 15 people in its administrativedepartment,compared to 16 people at the same date in 2012.

Selling expenses amounted to EUR1.6 million in the first three months endedMarch31, 2013, compared to EUR0.01 million in the first quarter of 2012. Sellingexpenses correspond to the costs of building Nicox's commercialorganization inthe US and in Europe following the in-licensing and commercial launch ofAdenoPlus™ in 2012. On March 31, 2013, the Group employed 15 people initssales and marketing department compared with none as of March 31, 2012.

Other income

Other income was EUR0.2 million on March 31, 2013, unchanged from the sameperioda year earlier. In the first quarter of 2013, other income included EUR0.1millionof operational subsidies from the research tax credit in France and EUR0.1millionof unrealized foreign exchange gains.

Other expense

Other expense, which refers principally to restructuring costs, amounted toEUR0.3million in the first three months of 2013, compared to an income of EUR0.2millionin the first quarter of 2012. Said income resulted from the cancellation ofcontingencies related to restructuring expenses previously recognized whichwereno longer applicable in 2012.

Operating loss

For the first three months of 2013, the Group generated an operating lossofEUR4.3 million, compared to an operating profit of EUR4 million on March31, 2012.

Other results

In the first quarter of 2013, the Group recorded a net financial profit ofEUR0.05million compared to EUR0.1 million on March 31, 2012.

Total net loss for the period

Nicox recorded a net loss of EUR4.3 million for the three months endedMarch31, 2013, compared to a net profit of EUR4.2 million on March 31, 2012.Thissituation is explained by the strong decrease in revenues recognized overtheperiod compared to the first three months of 2012 which included asignificantmilestone payment from our partner Bausch + Lomb as set out above.

Consolidated statement of financial position

Intangible assets totaled EUR1.9 million at the end of the first quarter of2013and included EUR1.5 million corresponding to the license fee paid toRPS® for theworldwide licensing agreement signed in June 2012.

On March 31, 2013, financial assets amounted to EUR2.5 million, includingEUR0.8million corresponding to the re-fundable part of the option fee paid toRPS® inJune 2012, EUR1.4 million representing the fair value of the shares held byNicoxin Altacor and EUR0.3 million of security deposits.

The indebtedness incurred by Nicox is mainly short-term operating debt. OnMarch31, 2013, the Group's current liabilities totaled EUR3.8 million, includingEUR1.4million in accounts payable to suppliers and external collaborators, EUR1millionin taxes payable, EUR0.9 million in accrued compensation for employees,EUR0.4million in other contingencies and liabilities with respect to therestructuringcost accrued, and EUR0.1 million in other liabilities.

On March 31, 2013, the Group's cash and cash equivalents were EUR72.1million,compared to EUR77.5 million on December 31, 2012.

...................................

About Nicox

Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a new mid-sizedinternational player in the ophthalmic market by building a diversifiedportfolio of innovative therapies and diagnostic tools. With a heritage ofscientific, business development and commercial expertise, the Nicox teamisfocused on developing and marketing novel pharmaceuticals and diagnosticdevicesthat can help people to enhance their sight. In the United States, NicoxmarketsAdenoPlus™, a test for the differential diagnosis of acuteconjunctivitisin-licensed from RPS®.

The Company's pipeline includes latanoprostene bunod, a noveldrug-candidate based on Nicox's proprietary nitric oxide (NO)-donating R&Dplatform, developedin collaboration with Bausch + Lomb for the potential treatment of glaucomaandocular hypertension. Further NO-donating compounds are under development innon-ophthalmic indications, notably through partners, including Merck(known as MSDoutside the United States and Canada).

Nicox S.A. is headquartered in France and is listed on Euronext Paris(Compartment B: Small Caps). For more information please visitwww.nicox.com.

...................................

This press release contains certain forward-looking statements. AlthoughtheCompany believes its expectations are based on reasonable assumptions,theseforward-looking statements are subject to numerous risks and uncertainties,which could cause actual results to differ materially from thoseanticipated inthe forward-looking statements.

Risks factors which are likely to have a material effect on Nicox'sbusiness arepresented in the 4th chapter of the « Document de référence,rapport financierannuel et rapport de gestion 2012 » filed with the FrenchAutorité des MarchésFinanciers (AMF) on March 22, 2013 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, 2013

-----------------------------------------
For the period of three months ended
March 31,
-----------------------------------------
2013 2012
-----------------------------------------
(In thousands of EUR)
-----------------------------------------


Revenues 69 7,487

Cost of sales (86) -



Research & development expenses (957) (1,346)

Administrative expenses * (1,684) (2,483)

Selling expenses * (1,611) (9)

Other income 253 160

Other expense (325) 234



Operating profit (loss) (4,341) 4,043



Financial income 65 174

Financial expense (13) (36)



Profit (Loss) before income tax (4,289) 4,181

Income tax expense 20 (14)


---------------------------------------------------------------------------
Net profit (loss) (4,269) 4,167
---------------------------------------------------------------------------


Exchange differences on translation of
foreign operations (110) (9)

Other comprehensive income (loss) for
the period, net of tax (110) (9)


---------------------------------------------------------------------------
Total comprehensive income (loss) for
the period, net of tax (4,379) 4,158
---------------------------------------------------------------------------
Attributable to:

- Equity holders of the parent (4,379) 4,174

- Non-controlling interests - (16)



* Restated as of March 31, 2012 as Corporate development expenses were
previously reported as Selling expenses

INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION - MARCH 31, 2013

---------------------------------------------
As of March 31, 2013 As of December 31, 2012
---------------------------------------------
(In thousands of EUR )
---------------------------------------------


ASSETS

Non-current assets

Property, plant & equipment 606 791

Intangibles assets 1,865 1,801

Financial assets 2,526 2,550

Deferred income tax assets 106 54
---------------------------------------------
Total non-current assets 5,103 5,196
---------------------------------------------


Current assets

Inventories 34 26

Trade receivables 86 7

Government subsidies receivable 646 531

Other current assets 495 757

Prepaid expenses 392 154

Cash and Cash equivalents 72,097 77,477
---------------------------------------------
Total current assets 73,750 78,952
---------------------------------------------

---------------------------------------------
TOTAL ASSETS 78,853 84,147
---------------------------------------------


EQUITY AND LIABILITIES



Common shares 14,593 14,579

Other reserves 55,733 59,975
---------------------------------------------
Total Equity 70,326 74,554
---------------------------------------------


Non-current liabilities

Other contingencies and liabilities 4,618 4,618

Deferred income tax liabilities 8 8

Financial Lease 104 114
---------------------------------------------
Total non current liabilities 4,730 4,740
---------------------------------------------


Current liabilities

Other contingencies and liabilities 435 667

Financial lease 44 43

Trade payables 1,371 1,850

Social security and other taxes 1,881 2,145

Other liabilities 66 149
---------------------------------------------
Total current liabilities 3,797 4,853
---------------------------------------------



---------------------------------------------
TOTAL EQUITY AND LIABILITIES 78,853 84,147
---------------------------------------------

Nicox S.A.

Drakkar 2 | Bât D | 2405 route des Dolines | CS 10313 | SophiaAntipolis |06560 Valbonne | France

T: +33 (0)4 97 24 53 00 | F: +33 (0)4 97 24 53 99

www.nicox.com



Nicox: first quarter 2013 financial results:http://hugin.info/143509/R/1701778/562016.pdf



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(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: NICOX via Thomson Reuters ONE

[HUG#1701778]

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Email Contact

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