NicOx 2011 Financial Results Sophia Antipolis,

NicOx S.A. (NYSE Euronext Paris: COX) today announces its financial

results for the year ended December 31, 2011 and provides an overview

of its activities. 2011 Operational Summary

* Discussions with potential M&A and in-licensing targets continuing

to progress

* Continued reorganization of the structure of the Company to deliver

strategic goals

* Phase 2b glaucoma study completed by Bausch + Lomb with preliminary

results expected Q1 2012

* Preclinical and clinical results published and presented at

international congresses

* Formal Dispute Resolution submitted to U.S. Food and Drug

Administration (FDA) for naproxcinod

* Marketing Authorization Application for naproxcinod withdrawn in


* Agreement granting Ferrer an option on rights to naproxcinod in

selected European countries

2011 Financial Summary

Following the restructuring plan implemented by NicOx in late 2010,

research and development costs and administrative and selling costs

totalled EUR14.9 million in 2011, down sharply from EUR47.9 million in


In 2011, NicOx recorded a total net loss of EUR16.7 million, compared

to a total net loss of EUR43.9 million in 2010. On December 31, 2011,

the Company had cash and cash equivalents totalling EUR93.1 million,

compared to EUR107.3 million on December 31, 2010.

No revenues were recorded in 2011, compared to EUR7.4 million in 2010,

which related to the initial license payment received from Bausch +

Lomb as part of the worldwide licensing agreement signed in March


Eric Castaldi, Chief Financial Officer of NicOx, commented, "As a

result of our reorganization and cost base reduction, our cash burn

decreased significantly in 2011. We plan to continue our focus on cost

control while ensuring the best strategic use of our resources, as we

ended 2011 with cash and cash equivalents of more than EUR93 million."

Overall objective of building a specialist pharmaceutical company

The Company's overall objective is to become a late-stage development

and commercial organization through potential M&A, product acquisition

or in- licensing. The Company is targeting late-stage or marketed

products in selected specialist areas presenting significant growth

potential. Following a detailed screening and evaluation process,

NicOx is now in advanced discussions with targets of interest.

In addition, NicOx is also continuing to explore alternative funding

options to ensure the development of its early-stage programs in order

to maximize the potential of its nitric oxide (NO)-donating research

platform while preserving the Company's cash position for investment

in new areas. These funding options could include spin offs, joint

ventures and other forms of collaboration.

Preliminary results from glaucoma study expected in Q1 2012

A phase 2b clinical trial was completed by NicOx's partner Bausch +

Lomb with BOL-303259-X (previously called NCX 116 and PF-03187207) at

the end of December 2011. Preliminary results are expected in the

first quarter of 2012. BOL- 303259- X is an NO-donating prostaglandin

F2-alpha analogue which is thought to lower intraocular pressure (IOP)

through a dual mechanism of action. It was licensed in March 2010 to

Bausch + Lomb, a leading eye health company.

This phase 2b study is intended to identify the most effective dose of

BOL- 303259-X, administered in the evening, for the reduction of IOP.

A total of approximately 400 patients with open-angle glaucoma or

ocular hypertension were randomized to receive either BOL-303259-X

(various concentrations) or Xalatan@ 0.005% (latanoprost) for 28 days.

The primary efficacy endpoint is the reduction in mean diurnal IOP at

day 28.

Status of naproxcinod in the United States and in Europe

Naproxcinod has been developed by NicOx for the potential relief of

the signs and symptoms of osteoarthritis. In July 2011, NicOx

submitted a formal appeal under the U.S. FDA's Formal Dispute

Resolution process, regarding the decision issued in July 2010 by the

FDA not to approve the naproxcinod New Drug Application (NDA) that

NicOx had submitted in September 2009.

In March 2011, NicOx and Grupo Ferrer Internacional S.A., a subsidiary

of Ferrer Grupo, signed an agreement granting Ferrer an option, which

Ferrer could exercise following potential future regulatory approval

of naproxcinod, to take exclusive distribution rights for naproxcinod

in Greece and Portugal and co- marketing rights in Spain and Germany.

NicOx retains the right to enter into co- marketing agreements with

third parties in Spain and Germany, and full rights to naproxcinod in

all other territories.

In April 2011, NicOx withdrew the Marketing Authorization Application

(MAA) which had been submitted to the European Medicines Agency (EMA)

in December 2009. The decision was made following feedback at the

April 2011 meeting of the Committee for Medicinal Products for Human

Use (CHMP) that the CHMP would not adopt a formal positive opinion on

the basis of the submitted information. NicOx is still evaluating its

potential options with its advisors and with Ferrer.

Publication and presentation of preclinical and clinical results

In 2011, NicOx presented preclinical and clinical results in a number

of peer- reviewed journals and international congresses:

* In the ophthalmology field, preclinical results obtained with BOL-

303259- X(1) and NCX 434(2)(3) were published in international

journals and were presented in several congresses, including the

Association for Research in Vision and Ophthalmology (ARVO) and the

European Society of Ophthalmology meetings.

* New preclinical data obtained with NCX 226, a prototype NO-donating

compound developed in a research program targeting Pulmonary Arterial

Hypertension (PAH), were presented at the annual European League

Against Rheumatism (EULAR) congress and at the 10(th) World Congress

on Inflammation.

* Clinical and preclinical results for NCX 6560 were also presented in

several conferences, including the 40th European Muscle Conference

(EMC), the Arteriosclerosis, Thrombosis and Vascular Biology (ATVB)

scientific sessions and the European Atherosclerosis Society (EAS)


* Results from the pooled analysis of the three pivotal phase 3 trials

for naproxcinod (the 301, 302 and 303 studies) were published in the

American Journal of Cardiology(4).

* Preclinical results for NCX 1236, the lead prototype compound in a

research program targeting neuropathic pain, were presented at the

American Pain Society congress and in other conferences.

Collaborations with Ferrer and Merck

Following the signature of an amendment to the dermatology agreement

with Grupo Ferrer in October 2011, NicOx is now actively seeking a new

partner for the development and marketing of NCX 1047 in the United

States. NCX 1047 is an NO- donating anti-inflammatory drug developed

for dermatology indications. Preclinical results obtained with NCX

1047 support the potential for a differentiated product profile.

Under the revised agreement signed in September 2010 between NicOx and

Merck (known as MSD outside the United States and Canada), Merck has

the right to develop novel compounds using a new approach to nitric

oxide donation in certain cardiovascular indications. NicOx and Merck

have agreed that no further announcements on the compounds developed

by Merck under the collaboration are anticipated unless and until a

drug-candidate advances into phase 2 clinical studies.

Board of Directors

Birgit Stattin Norinder joined NicOx's Board in June 2011. Mrs Stattin

Norinder has served as CEO and Chairman of Prolifix Ltd (UK), a

biotechnology company targeting proliferative diseases. She brings

significant experience in product development and regulatory affairs

and has held several senior management positions in worldwide

pharmaceutical companies, including Pharmacia & Upjohn and Glaxo Group

Research Ltd.

Goran Ando stepped down as a director following expiry of his term of

office on June 15, 2011. In August 2011, Jean-Luc Belingard informed

NicOx of his decision to step down from the Board because of his

increased responsibilities at bioMerieux. The Company would like to

thank Dr Ando and M. Belingard for their support.

Review of the consolidated financial results as of December 31, 2011

and 2010

The 2011 consolidated financial statements, as approved by the Board

of Directors on February 28, 2012, have been certified by the

statutory auditors.


NicOx did not record any revenues in 2011 compared to EUR7.4 million

in 2010.

The revenues recognized in 2010 correspond to the initial license

payment received from Bausch + Lomb following the signature of a

licensing agreement in March 2010 that granted Bausch + Lomb exclusive

worldwide rights to develop and commercialize BOL-303259-X (NCX 116).

This amount was immediately recognized in revenues because the Company

will not have continuing involvement in the future development of the

compound which is the subject of this collaboration agreement.

Research and development costs, general, administrative and selling


Research and development costs and general, administrative and selling

costs decreased to EUR14.9 million in 2011 compared to EUR47.9 million

in 2010. This significant reduction results from the restructuring of

the Group's entities and activities announced in 2010. As part of the

restructuring, 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 the 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 a planned 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. In 2011, 60% of these expenses were attributable to

research and development and 40% to general, selling and

administrative expenses compared to 73% and 27% in 2010, respectively.

Research and development expenses totaled EUR9.0 million in 2011,

compared to EUR35.2 million in 2010. In 2011, research and development

expenses primarily related to activities at the research center and

ongoing regulatory activities for naproxcinod. On December 31, 2011,

the Group employed 36 people in research and development compared to

54 people at the same date in 2010.

In 2011, general and administrative expenses totaled EUR4.1 million

compared to EUR5.4 million on December 31, 2010, and include personnel

expenses in administrative and financial functions, as well as the

remuneration of corporate officers. In 2011, selling expenses were

EUR1.8 million, compared to EUR7.4 million in 2010, and for 2011

relate to communication and business development activities (including

the activities related to the evaluation of companies and products to

acquire or in-license). In 2010, these expenses also included

preparation for the potential future commercialization of naproxcinod

in the United States. On December 31, 2011, the Group employed 18

people in its selling, general and administrative departments compared

to 23 people at the same date in 2010.

Other income

Other income was EUR0.9 million in 2011, compared to EUR2.2 million in

2010. Other income corresponds to operational subsidies from research

tax credits in France.

Other expense

Other expense exclusively relates to restructuring costs. For 2011,

other expense was EUR3.6 million and included notably (i) an accrual

in an amount of EUR3.1 million corresponding to personnel expenses and

additional estimated costs to be paid in 2012 and 2013 related to the

most recent reduction in the Group's workforce as indicated above;

(ii) an amount of EUR1.0 million corresponding principally to

accelerated depreciation of fixed assets due to the restructuring; and

(iii) an income of EUR0.5 million due to the cancellation of

contingencies related to the restructuring of NicOx S.A previously

recognized in 2010, which are no longer applicable in 2011.

For 2010, other expense was EUR5.7 million and included (i) EUR5.5

million of personnel expenses related to the overall restructuring

plan of the Company and including notably an accrual in an amount of

EUR2.6 million corresponding to additional estimated costs to be paid

in 2011 and 2012 related to the reduction in workforce at the

Company's head office in France and its Italian subsidiary, based on

assumptions which may change; (ii) the cancellation of expenses

previously booked in an amount of EUR1.5 million further to the

cancellation of rights on stock options and free shares; and (iii)

EUR1.7 million corresponding to the cost of the closure of the offices

of NicOx Inc. in the U.S. excluding personnel expenses reported in (i)


Operating result

The operating loss decreased to EUR17.6 million in 2011, compared to

EUR44.0 million in 2010.

Other results

Net financial income totaled EUR1.1 million in 2011, compared to

EUR0.4 million in 2010, and mainly represents the returns on the

financial investments of the Company's cash and cash equivalents.

The income tax expense incurred by NicOx in 2011 relates to tax from

its US and Italian subsidiaries and totaled EUR0.05 million, compared

to EUR0.3 million in 2010.

Total net loss of the period

The total net loss was EUR16.7 million on December 31, 2011, compared

to EUR43.9 million at the same date in 2010. This decrease is

explained by the significant reduction in all the operating expenses

following the restructuring implemented after the decision of the FDA

not to approve naproxcinod in July 2010.

Consolidated statement of financial position

The indebtedness incurred by NicOx is mainly short-term operating

debt. On December 31, 2011, the Company's current liabilities were

EUR6.9 million, including EUR3.6 million in other contingencies and

liabilities principally with respect to the restructuring cost

accrued, EUR1.2 million in accounts payable to suppliers and external

collaborators, EUR1.0 million in accrued compensation for employees,

EUR0.9 million in taxes payable and EUR0.2 million for other


The Company's cash and cash equivalents were EUR93.1 million on

December 31, 2011, compared to EUR107.3 million on December 31, 2010.

(1) Krauss AH, Impagnatiello F, Toris CB, Gale DC, Prasanna G, Borghi

V, Chiroli V, Chong WK, Carreiro ST, Ongini E, Ocular hypotensive

activity of BOL- 303259-X, a nitric oxide donating Prostaglandin

F2alpha agonist, in preclinical models. Exp Eye Res. 2011, 93:


(2) Khoobehi B, Chiroli V, Ronchetti D, Miglietta D, Thompson H,

Ongini E, Impagnatiello F, Enhanced Oxygen Saturation in Optic Nerve

Head of Non- Human Primate Eyes Following the Intravitreal Injection

of NCX 434, an Innovative Nitric Oxide-Donating Glucocorticoid. J Ocul

Pharmacol Ther. 2011, 27(2):115-21.

(3) Impagnatiello F, Giambene B, Lanzi C, Pini A, Somma T, Bastia E,

Ongini E, Galassi F, Masini E. The nitric oxide (NO)- donating

triamcinolone acetonide, NCX 434, does not increase intraocular

pressure and reduces endothelin-1-induced biochemical and functional

changes in the rabbit eye, Br J Ophthalmol 2012 (in press).

(4) White WB, Schnitzer TJ, Bakris GL, Frayssinet H, Duquesroix B,

Weber M, Effects of Naproxcinod on Blood Pressure in Patients With

Osteoarthritis. Am. J. Cardiol. 2011, 107(9): 1338-45.

About NicOx

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical

company focused on the research, development and future

commercialization of drug candidates. NicOx is applying its

proprietary nitric oxide-donating R&D platform to develop an internal

portfolio of New Molecular Entities (NMEs) for the potential treatment

of inflammatory, cardio-metabolic and ophthalmological diseases.

The Company's pipeline includes several nitric oxide-donating NMEs,

which are in development internally and with partners, who include

Merck (known as MSD outside the United States and Canada), Bausch +

Lomb 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 4(th) chapter of the " Document de

reference, rapport financier annuel et rapport de gestion 2010 " filed

with the French Autorite des Marches Financiers (AMF) on February 25,

2011 and available on NicOx's website

( and on the AMF's website


Consolidated statement of Comprehensive Income - December 31, 2011


As of December 31,

2011 2010


(in thousands of EUR except for

per share data)


Revenues - 7,423

Research and development (8,998) (35,161)


Administrative expenses (4,112) (5,364)

Selling expenses (1,817) (7,389)

Other income 866 2,157

Other expense (3,569) (5,663)

Operating loss (17,630) (43,997)

Finance income 1,055 475

Finance expense (6) (95)

Loss before income tax (16,581) (43,617)

Income tax expense (54) (334)


Net loss (16,635) (43,951)


Exchange differences on translation of foreign (25) 23


Other comprehensive income (loss) for the (25) 23

period, net of tax


Total comprehensive income (loss) for the (16,660) (43,928)

period, net of tax


Attributable to:

- Equity holders of the parent (16,660) (43,928)

- Non-controlling interests - -


Basic and diluted loss per share attributable

to equity holders of the (0.23) (0.61)



consolidated Statement of Financial Position - December 31, 2011


As of

December 31,

2011 2010


(in thousands of




Non-current assets

Property, plant & equipment 843 2,130

Intangible assets 117 386

Other financial assets 263 247

Deferred income tax assets 65 39


Total non-current assets 1,288 2,802


Current assets

Government subsidies receivable 866 1,509

Other current assets 367 909

Prepaid expenses 172 377

Cash and cash equivalents 93,136 107,335


Total current assets 94,541 110,130



TOTAL ASSETS 95,829 112,932



Common shares 14,563 14,509

Other reserves 69,761 85,979

Non-controlling interests . - -


Total Equity 84,324 100,488


Non-current liabilities

Other contegencies and liabilities 4,592 4,548

Deferred income tax liabilities 3 96

Finance lease 58 83


Total non-current liabilities 4,653 4,727


Current liabilities

Other contingencies and liabilities 3,590 2,800

Finance lease 24 30

Trade payables 1,185 2,045

Current income tax payable - -

Social security and other taxes 1,890 2,627

Other liabilities 163 215


Total current liabilities 6,852 7,717





NicOx S.A.

Les Taissounieres - Bat HB4 - 1681 route des Dolines - BP313 - 06906

Sophia Antipolis Cedex - France

Tel: +33 (0)4 97 24 53 00 ? Fax: +33 (0)4 97 24 53 99

NicOx 2011 Financial Results:

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