NicOx first half 2012 financial results

Marketwired

SOPHIA ANTIPOLIS CEDEX, FRANCE--(Marketwire -07/27/12)-NicOx S.A. (COX.PA)(COX.PA) today reports financial results for thesix months ended June 30, 2012, and provided an update on its activities.

Key highlights for the first half of 2012

* Worldwide in-licensing agreement with RPS® for innovativediagnostic tests in the ocular field, including AdenoPlus™

* Management team strengthened with the appointments of Jerry St. Peterin the United States and Philippe Masquida in Europe

* Positive phase 2b results observed with glaucoma candidateBOL-303259-X; Bausch + Lomb to move compound into phase 3 development program

* 11.8% investment in Altacor, a privately-held ophthalmology companybased in the United Kingdom

"During the first six months of 2012, NicOx made significantprogress indelivering its strategy of becoming an international, late-stagedevelopment andcommercial ophthalmology player," said Michele Garufi, Chairman andCEO ofNicOx. "We achieved the first step through the acquisition of worldwiderightsto a promising portfolio of ocular diagnostic products from RPS®. Weexpect tolaunch AdenoPlus™, our first commercially available product, by theend of2012 under the leadership of Jerry St. Peter in the US and PhilippeMasquida inEurope. Discussions are advancing to further expand our product portfolioin theUS and in Europe through further acquisitions and in-licensing."

Eric Castaldi, Chief Financial Officer of NicOx, added: "We areinvesting increating small, specialist sales teams in the US and Europe tocommercialise therecently in-licensed AdenoPlus™ diagnostic test. As of June 30,2012, theCompany had cash and cash equivalents of more than EUR88 million, puttingus in agood position to continue to invest in targeted commercial andlate-stageopportunities in ophthalmology."

Financial summary

Revenues were EUR7.5 million in the first half of 2012, compared to zerofor thecorresponding period of 2011. This reflects a one-off $10 millionmilestonepayment (corresponding to EUR7.5 million) received from Bausch + Lombin April2012, following its decision to continue the development of BOL-303259-X.

Research and development costs and administrative and selling costswereEUR8.1 million in the first half of 2012, compared to EUR8.8 million inthe firsthalf of 2011.

NicOx recorded a total net loss of EUR0.4 million in the first half of2012,compared to a net loss of EUR7.8 million for the same period in 2011.On June30, 2012, the Group had cash and cash equivalents totaling EUR88.5million,compared to EUR93.1 million on December 31, 2011.

Review of the first six months of 2012

Worldwide licensing agreement with RPS® for ocular diagnostics

NicOx and Rapid Pathogen Screening, Inc (RPS®) entered into alicensingagreement in June 2012, with effect from July 2012, granting NicOxworldwiderights to unique point-of-care tests in the ocular field. AdenoPlus™,aneasy-to-use diagnostic test for the in-office detection ofadenoviralconjunctivitis, is already authorized for marketing in the US and inEurope. TheCompany expects to launch AdenoPlus™ in the US and in key Europeanmarketsby the end of 2012.

The worldwide licensing agreement also covers two additional diagnostictestscurrently in development as well as an exclusive worldwide option tonegotiatean agreement for an additional promising product, based on RPS®meetingcertain milestones which include on-going external discussions.

Under the agreement, NicOx paid RPS® a total of $4 million inlicense andoption fees. The financial terms also include single-digitroyalties andpotential additional milestone payments of up to $2 million. NicOx willalso payhalf of the development costs for the two development-stage products,subject toan agreed budget.

Bausch + Lomb to move into phase 3 following positive phase 2b results

The phase 2b study conducted by Bausch + Lomb with BOL-303259-X (NCX116) inpatients with open-angle glaucoma or ocular hypertension met itsprimaryendpoint and showed promising results on a number of secondary endpoints.Bausch+ Lomb will initiate a global phase 3 development program forBOL-303259-X andpaid a $10 million milestone payment to NicOx (EUR7.5 million) in April2012.BOL-303259-X is a novel nitric oxide-donating prostaglandin F2 alpha analoglicensedby NicOx to Bausch + Lomb in March 2010.

Building the Group's commercial organization

In the first half of 2012, the Company appointed Jerry St. Peter asExecutiveVice President and General Manager of NicOx Inc., the U.S. subsidiary ofNicOx,and Philippe Masquida as Executive Vice President, Managing Director ofEuropeanOperations. Both Jerry St. Peter and Philippe Masquida have extensivesenior-level international experience, notably in the ophthalmology field.

Following the in-licensing of AdenoPlus™, which is alreadyauthorized formarketing in the US and in Europe, NicOx is building up itscommercialorganization in the US and in Europe. The commercial teams willmanage thecommercialization of AdenoPlus™ and other ophthalmology products,bothdiagnostic and therapeutic, that the Company plans to acquire orin-license inthe future.

Investment in Altacor

In March 2012, NicOx acquired 11.8% of the shares of Altacor, aprivately-heldophthalmology company based in the United Kingdom. Altacor marketsClinitas™,a range of five products for dry eye, in the UK and Ireland. On May 31,2012,NicOx's Board of directors decided not to exercise an option toacquire theremaining 88.2% of equity of Altacor. NicOx retains its 11.8% stake andwillcontinue to support Altacor through the presence of Gavin Spencer,ExecutiveVice President, Corporate Development of NicOx as a member of Altacor'sBoard ofDirectors.

Meeting with the FDA on April 3, 2012

NicOx met with the US Food and Drug Administration (FDA) on April 3,2012, todiscuss the proposed use of naproxcinod 375 mg twice daily (bid)for thetreatment of signs and symptoms of osteoarthritis (OA) of the knee,under aproposed new NDA (New Drug Application) that would require additionalclinicaldata prior to any such NDA submission.

Having assessed the requirements for further clinical data discussedwith theFDA and its impact on the overall development program of naproxcinod,NicOx hasinitiated the process of seeking a partner to fund and manage anyfurtherdevelopment and potential commercialization of naproxcinod.

NicOx had previously submitted an NDA for naproxcinod 375 mg bid and 750mg bidfor the treatment of signs and symptoms of OA not limited to the knee.NicOxreceived a Complete Response Letter in July 2010 stating that the FDAdid notapprove that naproxcinod NDA. NicOx initiated a Formal DisputeResolutionprocess in July 2011 regarding that decision involving the previouslysubmittedNDA. These were not the topic of the April 3, 2012 meeting.

Subject to NicOx finding a potential partner to pursue thedevelopment ofnaproxcinod 375 mg bid in knee OA, if the Company moves forward withthis newNDA, the Company anticipates that the Formal Dispute Resolutionprocessinitiated in July 2011 under the previously submitted NDA would be closed.

Nitric oxide (NO)-donating R&D pipeline

In line with the strategic decision to become a late-stagedevelopment andcommercial specialty ophthalmology company, the Board decided toreview andrationalize the Company's R&D pipeline and to discontinue any programsdeemednon-core in view of the Company expansion in the ophthalmic space. As aresultthe Company will no longer pursue the development of NCX 6560, a newmolecularentity for cardiovascular indications, or research programstargetingneuropathic pain (including NCX 1236) and pulmonary arterialhypertension(including NCX 226).

The Company is evaluating various options to pursue the developmentofNO-donating compounds targeting eye conditions, including NCX 434 and NCX422. TheCompany may choose to develop these programs in-house or with a partner.

Review of the consolidated financial results for the six months endedJune30, 2012 and 2011

The interim consolidated financial statements for the six months endedJune30, 2012 and 2011 have been prepared in accordance with applicableIFRSprinciples and a limited review has been performed by the auditors.

On March 21, 2012, NicOx acquired 11.8% of the shares of Altacor, aprivately-held ophthalmology company based in the United Kingdom, and,further, enteredinto an exclusive option agreement to acquire the remaining shares ofAltacor inshares and/or warrants, cash or a combination of cash and shares. UnderIAS 27,the Group was deemed to have the power to control Altacor as it had,until May31, 2012, the option to acquire the remainder of Altacor's shares incash.Therefore, on March 31, 2012 Altacor's transaction was considered abusinesscombination in accordance with the above mentioned accountancy rules. Inthiscontext, NicOx has accounted for the combination of NicOx and Altacorusing thepurchase method of accounting in accordance with IFRS 3,'BusinessCombinations'.

On May 31, 2012 NicOx decided not to exercise the option toacquire theremaining 88.2 % of equity of Altacor. Therefore, on June 30, 2012NicOx isdeemed to have lost the power to control Altacor and in consequence hasreversedall the assets and liabilities of Altacor as of May 31, 2012.

Nevertheless, under IFRS principles the Group is deemed toexercise asignificant influence over Altacor as a result of its participation in thesharecapital and Board of Directors of Altacor. Consequently, thepresentedconsolidated half-year financial statements for the six months to June 30,2012include Altacor for the period from May 31 to June 30, 2012, on the basisof theequity method.

Consolidated statement of comprehensive income

Revenues

For the six month ended June 30, 2012, NicOx revenues totaled EUR7.5millioncompared to zero revenue in the first semester of 2011.

The revenues recognized on June 30, 2012 correspond to the milestonepayment of$10 million invoiced to Bausch + Lomb in March 2012, following theirdecision tocontinue the development of BOL-303259-X (NCX 116). This amount hasbeenimmediately recognized in revenues because the Company will not havecontinuinginvolvement in the future development of this compound which is thesubject ofthe collaboration agreement signed in 2010 with Bausch + Lomb.

Research and development costs, administrative and selling costs

For the first half of 2012, research and development costs,administrative andselling costs decreased to EUR8.1 million compared to EUR8.8 million forthe firstsemester of 2011. In 2010 and in 2011, NicOx implemented twoconsecutiverestructurings of its entities and activities. As part of therestructuring in2010, the US offices of NicOx were closed in August 2010, the headcountof theFrench and Italian entities of the Group were significantlyreduced andactivities were redefined in order to protect the Company's cash andcashequivalents and refocus the Group's key strategic priorities. In thelastquarter of 2011, the Group has implemented an additional reductionof itsworkforce by approximately one third in order to align its structurewith thecorporate strategy of becoming an international, late-stagedevelopment andcommercial ophthalmology Group. On June 30, 2012, 43% of theseexpensesconcerned research and development expenses and 57% administrative andsellingexpenses, compared to 60% and 40%, respectively, on June 30, 2011.

During the first semester of 2012, research and development expenses wereEUR3.2million, compared to EUR5.2 million during the same period in 2011. Inthe firstsix months of 2012, research and development expenses primarilyrelated toactivities at the research center and ongoing regulatory activitiesfornaproxcinod. On June 30, 2012, the Group employed 19 people inresearch anddevelopment, compared to 40 people at the same date in 2011.

Administrative expenses were EUR1.9 million in the first six monthsof 2012compared to EUR2.6 million during the same period in 2011 and includepersonnelexpenses in administrative and financial functions, as well as theremunerationof corporate officers. Selling expenses totaled EUR3.0 million on June 30,2012,compared to EUR1.0 million in the first semester of 2011, and correspondfor thefirst six months of 2012 principally to communication and businessdevelopmentactivities (including notably EUR0.7 million of costs incurred over theperiod inrelation with the acquisition of the 11.8% of Altacor). The Groupemployed 18people in its selling and administrative departments on June 30, 2012,comparedto 16 people on June 30, 2011.

Other income

During the first six months of 2012, other income was EUR0.6 millioncompared toEUR0.5 million in the first semester of 2011. In 2012, other incomecorrespondsfor EUR0.2 million to the operational subsidies from the research taxcredit inFrance and for EUR0.4 million to an unrealized foreign exchange gain.

Other expense

Other expense, which refers exclusively to restructuring costs, amounted toEUR0.6million on June 30, 2012, compared to an income of EUR0.1 millionon June30, 2011. On June 30, 2012, the Group has accrued an amount of EUR0.9million withrespect to an undertaking vis-à-vis employees of the Italiansubsidiary in theevent of a potential further restructuring.

Operating loss

For the first six months of 2012 the Group generated an operating loss ofEUR0.5million, compared to an operating loss of EUR8.2 million during the sameperiod in2011.

Other results

In the first six months of 2012, net financial income totaled EUR0.1million(including the share of Altacor's results), compared to EUR0.4 millionduring thefirst six months of 2011, and mainly represents the returns on thefinancialinvestments of the Company's cash and cash equivalents.

The income tax expense incurred by NicOx during the first semester of2012relates to tax from its Italian subsidiary and totaled EUR0.04 million,comparedto EUR0.08 million on June 30, 2011.

Total net loss for the period

On June 30, 2012, NicOx recorded a net loss of EUR0.4 million comparedto EUR7.8million on June 30, 2011. This significant decrease of the net loss in thefirstsix months of 2012 is explained by the strong increase of therevenuesrecognized over the period as indicated above.

Consolidated statement of financial position

The indebtedness incurred by NicOx is mainly short-term operating debt. OnJune30, 2012, the Group's current liabilities totaled EUR5.2 million,including EUR1.8million in accounts payable to suppliers and external collaborators,EUR1.6million in other contingencies and liabilities with respect to therestructuringcost accrued, EUR1.0 million in taxes payable and EUR0.8 millionin accruedcompensation for employees.

On June 30, 2012, the Group's cash and cash equivalents were EUR88.5million,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 ophthalmology group based aroundtherapeutics,diagnostics and devices.

NicOx has in-licensed innovative ocular diagnostics from RPS®,includingAdenoPlus™, a test for the detection of adenoviral conjunctivitisalreadyauthorized for marketing in the United States and Europe. The Companyhas apartnership with Bausch + Lomb for the development of BOL-303259-X, anovelglaucoma candidate based on NicOx's proprietary nitricoxide-donating R&Dplatform.

Further nitric oxide-donating compounds are under development innon-ophthalmology indications notably through partners, including Merck(known asMSD outside the United States and Canada) and Ferrer.

NicOx S.A. is headquartered in France and is listed on EuronextParis(Compartment C: Small Caps).


This press release contains certain forward-looking statements.Although theCompany believes its expectations are based on reasonable assumptions,theseforward-looking statements are subject to numerous risks anduncertainties,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 2011 » filed with the FrenchAutorité des MarchésFinanciers (AMF) on February 29, 2012 and available on NicOx'swebsite(www.nicox.com) and on the AMF's website (www.amf-france.org).


 
Interim Consolidated statement of Comprehensive Income - june 30, 2012

----------------------------
For the period of six months
ended, June 30,

2012 2011
----------------------------
(in thousands of EUR except
for per share data)
----------------------------


Revenues .......................     7,552 -





Research and development expenses (3,173) (5,250)

Administrative expenses..................     (1,932) (2,562)

Selling expenses.....................     (2,956) (976)

Other income..........................     627 532

Other expense......................     (570) 102

Operating loss .........................     (452) (8,154)



Finance income ......................     321 471

Finance expense......................     (85) (39)

Share of Profit (loss) of associates........     (95) -




Loss before income tax .     (311) (7,722)

Income tax expense.........................     (42) (83)


--------------------------
Net loss.........................     (353) (7,805)
--------------------------


Exchange differences on translation of (21) 47
foreign operations....

Other comprehensive income (loss) for the (21) 47
period, net of tax


---------------------------
Total comprehensive income (loss) for the (374) (7,758)
period, net of tax
---------------------------
Attributable to:

- Equity holders of the parent 374 7,758

- Non-controlling interests - -


---------------------------
Basic and diluted loss per share attributable 0.00 (0.11)
to equity holders of the
parent......................
---------------------------




Interim consolidated Statement of Financial Position - june 30, 2012


---------------------------
As of As of
June 30, December 31,
2012 2011
---------------------------
(in thousands of EUR)
---------------------------
ASSETS



Non-current assets

Property, plant & 611 843
equipment ................

Intangible 99 117
assets ....................

Investments in associates and 2,317 -
joint ventures..........

Other financial assets 273 263
..................

Deferred income tax 56 65
assets ...............
---------------------------
Total non-current 3,356 1,288
assets ................
---------------------------


Current assets

Government subsidies 1,087 866
receivable... ...........

Other current 795 367
assets ..................

Prepaid 334 172
expenses ..................

Cash and cash 88,509 93,136
equivalents ................
---------------------------
Total current 90,725 94,541
assets ..................
---------------------------

---------------------------
TOTAL ASSETS.................. 94,081 95,829
---------------------------


EQUITY AND LIABILITIES


Common 14,578 14,563
shares .....................

Other 69,58 69,761
reserves ....................

Non-controlling - -
interests ...............
-------------------------
Total Equity 84,136 84,324
......................
-------------------------



Non-current
liabilities


Other contegencies and 4,671 4,592
liabilities ..............

Deferred income tax 1 3
liabilities .............

Finance 46 58
lease ......................
-----------------------
Total non-current 4,718 4,653
liabilities ..............
-----------------------


Current liabilities

Other contingencies and 1,55 3,59
liabilities .............

Finance 24 24
lease ......................

Trade payables .................. 1,793 1,185

Social security and other 1,782 1,89
taxes .............

Other 78 163
liabilities ...................
-----------------------
Total current 5,227 6,852
liabilities.................
-----------------------

-----------------------
TOTAL EQUITY AND 94,081 95,829
LIABILITIES...........
-----------------------

NicOx first half 2012 financial results:http://hugin.info/143509/R/1629870/522139.pdf


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Source: NICOX via Thomson Reuters ONE

[HUG#1629870]

Contact:
CONTACTS
NicOx
Gavin Spencer
Executive Vice President Corporate Development
Tel +33 (0)4 97 24 53 00
Email Contact
www.nicox.com
NicOx Media Relations
FTI Consulting London
Jonathan Birt
D+44 (0)20 7269 7205
M +44 (0)7515 597 858
Email Contact
Stephanie Cuthbert
D +44 (0)20 3077 0458
M +44 (0)7843 080947
Email Contact
FTI Consulting Paris
Guillaume Granier
D +33 1 47 03 68 61
M +33 6 32 65 79 28
Email Contact
Stephanie Bia
D + 33 (0) 1 47 03 68 16
M + 33 (0) 6 79 44 66 55
Email Contact
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

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