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Nicox First Half 2013 Financial Results and Business Update

July 31, 2013 - Sophia Antipolis, France

Nicox S.A. (NYSE Euronext Paris: COX) today announced its financial results forthe six months ended June 30, 2013, and provided an update of itsactivities.

Michele Garufi, Chairman and CEO of Nicox, said:

"We have made good progress in the expansion of our product pipeline duringthefirst six months of the year, with the addition of an innovative line offoureye care products licensed from an European partner for Europe, Middle EastandAfrica planned to be launched in the first quarter of 2014, and aproprietaryDry Eye panel for the diagnosis of Sjögren's Syndrome from ImmcoDiagnosticsunder a promotion agreement for North America and an option for the rest oftheworld. The Dry Eye panel, together with our RPS point-of-care diagnostictests,enables the Company to provide eye care practitioners and their patientswith aunique and innovative offering in diagnostics. In parallel, our EuropeanandInternational team has been strengthened and we will continue to structuretheoperational organization of the Company to support our plannedinternationalgrowth.

As planned, Bausch + Lomb has initiated its pivotal Phase 3 studies forlatanoprostene bunod. This compound is a major asset of our pipeline andfurtherdemonstrates the value of Nicox's NO-donating research platform as aninnovativetherapeutic approach in ophthalmology."

Operational Summary for the first half 2013

* Expansion of the ophthalmic pipeline:
* New range of eye care products developed for a major therapeutic
class expected to be launched in 1Q 2014; exclusive supply and
distribution agreement for Europe, Middle-East and Africa with an
European private company
* Dry Eye panel for the early diagnosis of the Sjögren's
exclusive North-American agreement with Immco Diagnostics
* Pivotal Phase 3 program for latanoprostene bunod initiated by Bausch +
Lomb in January 2013; positive Phase 2b results presented at the AGS
(American Glaucoma Society) in San Francisco on March 2(nd) 2013
* Strengthened ophthalmology expertise:
* Election of Vicente Anido, Jr., PhD., to the Company's Board of
* Further strengthening of European and International Operations team
with key industry hires
* Positive pre-clinical results on naproxcinod in models of muscular
dystrophy presented at MDA Scientific Conference in Washington
(DC, United States); naproxcinod potential focus on muscular dystrophy

Post Reporting Period Events

 * Initiation by Bausch + Lomb of Japanese studies for latanoprostene bunod in July 2013

Financial Summary for the first half 2013

Nicox's revenues amounted to EUR0.2 million for the six month ended June30, 2013. This compares to EUR7.5 million for the same period in 2012,whichincluded receipt of a significant milestone payment from Bausch + Lomb.

Selling, administrative and research and development costs were EUR9.3million inthe first half of 2013 (H1 2012: EUR8.1 million), with 40% of these costsrelatedto selling expenses, reflecting the ongoing transformation of Nicox into acommercial ophthalmic company.

As a result, Nicox recorded a net loss of EUR9.2 million for the six monthsendedJune 30, 2013, compared to a net loss of EUR0.4 million in the first halfof 2012.As of June 30, 2013, the Group had cash and cash equivalents of EUR67.4million,compared to EUR77.5 million on December 31, 2012.

Review of the first six months of 2013

 * Expansion of the ophthalmic pipeline

During the first half of 2013, Nicox has signed two new product agreements,which have significantly expanded its ophthalmic pipeline.

In March 2013, Nicox entered into an exclusive supply and distributionagreementfor a range of four innovative eye care products with an undisclosedprivateEuropean pharmaceutical company specializing in ophthalmics. Nicox expectstobegin launching this family of products directly and through partners inthefirst quarter of 2014. These products have been developed for a majortherapeutic class with a differentiated formulation. Under the terms of theagreement, Nicox will have exclusive rights to market, sell and distributetheseproducts in Europe, Middle East and Africa. Nicox did not make any upfrontpayments.

In June 2013, Nicox entered into an exclusive agreement with ImmcoDiagnosticsInc., a worldwide leader in autoimmune diagnostic products and services, topromote the Dry Eye panel, a proprietary laboratory test targeted at theearlydetection and diagnosis of Sjögren's Syndrome, to eye careprofessionals inNorth America (US, Canada, Puerto Rico, Mexico). Dry eye is one of theearlyprimary symptoms of the disease, eye care practitioners are poised to playasignificant role in the early identification. Under the terms of theagreement,Nicox will receive a majority share of revenue generated from eye carepractitioners. No upfront or milestones payments have been made by Nicox.Nicoxalso has a nine-month option to negotiate an agreement to promote the testinthe rest of the world. During this period, Immco and Nicox are planning tostudyand evaluate the feasibility and implementation steps for the test in othermarkets, including Europe.

 * Advanced clinical trials for latanoprostene bunod

In January 2013, Bausch + Lomb initiated a Phase 3 clinical program forlatanoprostene bunod (previously known as BOL-303259-X). The initiation ofthisprogram started with two pivotal studies, APOLLO and LUNAR, forregistration inthe United States. These studies are designed to compare the efficacy andsafetyof latanoprostene bunod administered once daily (QD) with timolol maleate0.5%administered twice daily (BID) in lowering intraocular pressure (IOP) inpatients with open-angle glaucoma or ocular hypertension. The primaryendpointof both studies, which will include a combined total of approximately 800patients, is the reduction in mean IOP measured at specified time pointsduringthree months of treatment.

In July 2013, Bausch + Lomb initiated two other studies, JUPITER andKRONUS, inJapan, the second largest ophthalmic market in the world. JUPITER is aPhase 3study enrolling approximately 130 subjects. Its purpose is to demonstratetheclinical safety of latanoprostene bunod 0.024% administrated once daily(QD)over a one-year treatment period. This study is required for registrationinaccordance with the International Conference on Harmonisation (ICH) and theJapanese regulatory authority, the Pharmaceuticals and Medical DevicesAgency(PMDA). KRONUS is a Phase 1 study. Its primary objective is to evaluate theeffect of latanoprostene bunod 0.024% administered once daily (QD) inreducingIOP measured over a 24-hour period in approximately 24 healthy maleJapanesesubjects. A confirmatory efficacy study is expected to be required for theJapanese registration of latanoprostene bunod.

 * Strengthened ophthalmology expertise

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 brings a wealth of experience from the pharmaceutical industry andmorespecifically in the ophthalmology area. Under the leadership of PhilippeMasquida as Executive Vice President, Managing Director of European andInternational Operations, the team is responsible for the commercializationofNicox's ophthalmic products in Europe and other important markets aroundtheworld outside of North America.

In June 2013 shareholders approved the appointment of Vicente Anido, Jr.,PhD.,to the Company's Board of Directors at the 2013 Ordinary ShareholderMeeting.Dr. Anido is a highly experienced and respected leader in the ophthalmologysector and currently serves as Chairman and CEO of Aerie PharmaceuticalsInc.From 2001 to 2012, he served as President and Chief Executive Officer ofISTAPharmaceuticals prior to its acquisition by Bausch + Lomb.

 * Nitric oxide-donating pipeline in other therapeutic areas

In April 2013, Nicox announced promising pre-clinical results ofnaproxcinod inmodels of muscular dystrophies. A long-term confirmatory study (nine monthsoftreatment), sponsored by Nicox and conducted at the Children's NationalMedicalCenter (Washington DC), showed that naproxcinod improves skeletal andcardiacmuscle function and reduces skeletal muscle inflammation in mdx mice. Thedatawas presented in a poster session on April 22nd at the muscular dystrophyAssociation (MDA) Scientific Conference in Washington, DC.

Following these positive results, Nicox is evaluating the opportunity topartnernaproxcinod for development as an adjuvant for the treatment of musculardystrophy. Separately, the Company continues to seek partners to out-licencenaproxcinod for the treatment of the signs and symptoms of osteoarthritisof theknee. This approach is aimed at maximising the opportunities to progressthedevelopment of naproxcinod in one of these indications.

In April 2013, Nicox and Ferrer agreed to terminate their nitric oxide-donatingsteroids collaboration in dermatology, including the termination of theresearch& development, licence and option agreement of April 28, 2004. Nicox doesnotintend to continue, nor seek another partner to continue, the developmentofnitric oxide-donating steroids in dermatology.

 * Presentations of research, preclinical and clinical results in the ophthalmology field

In the first half of 2013, Nicox presented two scientific posters at theAssociation for Research in Vision and Ophthalmology (ARVO) and theEuropeanSociety of Ophthalmology (SOE) meetings. The posters reported researchresultson the role of nitric oxide (NO) in the physiology of the eye and morespecifically in the regulation of intraocular pressure (IOP).

Nicox also presented, at the 245(th) American Chemical Society (ACS), theresearch program which led to the discovery of nitric oxide-donatingprostaglandin F2-alpha analogs, which have been shown to reduce intraocularpressure (IOP), potentially through interaction with both NO/cGMP pathwayandprostaglandin F2-alpha (FP) receptors.

In addition, the Phase 2b results for latanoprostene bunod were presentedat theAmerican Glaucoma Society 23rd Annual Meeting by Robert N. Weinreb, MD,chairman& distinguished professor of Ophthalmology, University of California SanDiegoand director, Shiley Eye Center and Hamilton Glaucoma Center, and a posterwaspresented at the Association for Research in Vision and Ophthalmology(ARVO) andat the World Glaucoma Congress (WGS).

Review of the consolidated financial results as of June 30, 2013 and 2012

The consolidated half-year financial statements for the six months to June30, 2012 include Altacor (a privately-held ophthalmology company in whichNicoxacquired in March 2012 11.8% of the shares) for the period from May 31 toJune30, 2012, on the basis of the equity method.

Consolidated statement of comprehensive income


Nicox's revenues amounted to EUR0.2 million for the six months ended June30, 2013, compared to EUR7.5 million for the same period of 2012.

Revenues during the first half of 2013 correspond to the sales ofAdenoPlus®, arapid point-of-care diagnostic test in-licensed from Rapid PathogenScreening,Inc (RPS®) in June 2012. Nicox initiated its own marketing activitiesforAdenoPlus® in the US in October 2012 and is in the process ofstrengthening itsinternal sales force to support the commercialization of its growingportfolioof ophthalmic products. In Europe and the rest of the world, whileAdenoPlus® isavailable for sale, Nicox is initially focusing on key activities to secureitsreimbursement in the largest European countries.

The revenues recognized in the first six month of 2012 correspond to themilestone payment of $10 million received from Bausch + Lomb in April 2012,following their decision to continue the development of latanoprostenebunod(previously known as BOL-303259-X).

Cost of sales

Cost of sales amounted to EUR0.2 million during the first six months of2013. Thisitem corresponds to the cost of goods sold in relation to the sales ofAdenoPlus® and includes all the costs related to the manufacturing oftheproducts sold.

Selling, administrative and research and development costs

Selling, administrative and research and development costs were EUR9.3million inthe first half of 2013 compared to EUR8.1 million in the first semester of2012.In the first half of 2013, 40% of these costs were related to sellingexpenses,39% to administrative expenses (including the corporate developmentexpensespreviously reported as selling expenses) and 21% to research anddevelopmentexpenses. This compared to 6% related to selling expenses, 55% toadministrativeexpenses (including the corporate development expenses previously reportedasselling expenses), and 39% to research and development expenses, in thefirsthalf of 2012. The change reflects the ongoing transformation of Nicox intoacommercial ophthalmic company.

For the first six months ended June 30, 2013, selling expenses were EUR3.7million, compared to EUR0.5 million in the first half of 2012. Sellingexpensescorrespond to the costs of building Nicox's commercial organization in theUSand in Europe to support the planned business activities related to ourcurrentportfolio and to future products we expect to add to our pipeline. On June30, 2013, the Group employed 16 people in its sales and marketingdepartmentcompared with 2 as of June 30, 2012.

During the period, administrative expenses amounted to EUR3.6 million,compared toEUR4.4 million in the first half of 2012, and include personnel expenses inadministrative and financial functions, as well as the remuneration ofcorporateofficers, and since 2012, communication and business development expenseswhichwere previously reported in selling expenses. Administrative expenses forthefirst six months of 2013 are substantially lower than for the same periodof2012 due to the fact that administrative expenses in an amount of EUR0.7millionhad been recorded in 2012 in relation to the acquisition of 11.8% ofAltacor, aprivately-held ophthalmology company based in the United Kingdom. On June30 2013 and 2012, the Group employed 16 people in its administrativedepartment.Research and development expenses totaled EUR1.9 million for the first sixmonthsended June 30, 2013, compared to EUR3.2 million in the first semester of2012. Inthe first six months of 2013, research and development expenses wereprimarilyrelated to activities at the research center and ongoing regulatoryactivitiesfor naproxcinod. The Group employed 12 people in research and developmentonJune 30, 2013, compared to 19 people at the same date in 2012.Other income

Other income amounted to EUR0.3 million on June 30, 2013, compared toEUR0.6 millionin the first six months of 2012. In the first half of 2013, other incomeincluded EUR0.2 million of operational subsidies from the research taxcredit inFrance.

Other expense

Other expense, which refers principally to restructuring costs, was EUR0.2millionin the first six months of 2013, compared to EUR0.6 million on June 30,2012.

Operating loss

The Group generated an operating loss of EUR9.3 million in the first sixmonths of2013, compared to an operating loss of EUR0.5 million during the sameperiod in2012.

Other results

In the first semester of 2013, the Group recorded a net financial profit ofEUR0.04 million compared to EUR0.1 million (including the share ofAltacor'sresults) in the first half of 2012.

Total net loss for the period

Nicox recorded a net loss of EUR9.2 million for the six months ended June30, 2013, compared to a net loss of EUR0.4 million in the first semester of2012.This is explained by the strong decrease in revenues recognized over theperiodcompared to the first six months of 2012, which included a significantmilestonepayment 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 six monthsof2013 and included EUR1.5 million corresponding to the license fee paid toRPS® for the worldwide licensing agreement signed in June 2012.

On June 30, 2013, financial assets amounted to EUR2.3 million, includingEUR1.3million representing the fair value of the shares held by Nicox in Altacor,EUR0.8million corresponding to the re-fundable part of the option fee paid toRPS® inJune 2012, and EUR0.2 million of security deposits.

The indebtedness incurred by Nicox is mainly short-term operating debt. OnJune30, 2013, the Group's current liabilities totaled EUR3.8 million, includingEUR1.6million in accounts payable to suppliers and external collaborators, EUR1.4million in accrued compensation for employees, EUR0.6 million in taxespayable,EUR0.1 million in other contingencies and EUR0.1 million in otherliabilities.On June 30, 2013, the Group's cash and cash equivalents were EUR67.4million,compared to EUR77.5 million on December 31, 2012.

Nicox S.A.Drakkar 2 | Bât D | 2405 route des Dolines | CS 10313 | SophiaAntipolis |06560 Valbonne | FranceT: +33 (0)4 97 24 53 00 | F: +33 (0)4 97 24 53 99


About Nicox

Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a newinternationalplayer in the ophthalmic market by building a diversifiedportfolio ofinnovative therapies and diagnostic tools. With a heritage ofscientific,business development and commercial expertise, the Nicox team isfocused ondeveloping and marketing novel pharmaceuticals and diagnostic devicesthat canhelp people to enhance their sight. In the United States, NicoxmarketsAdenoPlus™, a test for the differential diagnosis of acuteconjunctivitis in-licensed from RPS®.

The Company's pipeline includes latanoprostene bunod, a novel drug-candidatebased on Nicox's proprietary nitric oxide (NO)-donating R&D platform,developedin collaboration with Bausch + Lomb for the potential treatment ofglaucoma andocular hypertension. Further NO-donating compounds are under development innon-ophthalmic indications, notably through partners, including Merck (knownas MSDoutside the United States and Canada).

Nicox S.A. is headquartered in France and is listed on EuronextParis(Compartment B: Small Caps). For more information please


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( and on the AMF's website (


 INTERIM CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME - JUNE 30, 2013 For the period of six months ended June 30, ---------------------------------- 2013 2012 (In thousands of EUR except for per share data) ---------------------------------- Revenues 183 7,552 Cost of sales (223) - Selling expenses (3,701) (485) Administrative expenses (3,611) (4,403) Research & development expenses (1,945) (3,173) Other income 265 627 Other expense (219) (570) Operating profit (loss) (9,251) (452) Financial income 128 321 Financial expense (87) (85) Share of Profit (loss) of associates - (95) Profit (Loss) before income tax (9,210) (311) Income tax expense 14 (42) -------------------------------------------------------------------------- Net profit (loss) (9,196) (353)-------------------------------------------------------------------------- Exchange differences on translation of (31) (21) foreign operations Other comprehensive income (loss) for (31) (21) the period, net of tax -------------------------------------------------------------------------- Total comprehensive income (loss) for (9,227) (374) the period, net of tax-------------------------------------------------------------------------- Attributable to: - Equity holders of the parent (9,227) (374) - Non-controlling interests - - -------------------------------------------------------------------------- Basic and diluted loss per share attributable to equity holders of the (0.13) (0.00) parent-------------------------------------------------------------------------- INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION - JUNE 30, 2013 ---------------------------------------- As of As of June 30, 2013 December 31, 2012 (In thousands of EUR) ---------------------------------------- ASSETS Non-current assets Property, plant & equipment 584 791 Intangibles assets 1,898 1,801 Financial assets 2,263 2,550 Deferred income tax assets 95 54 ---------------------------------------- Total non-current assets 4,840 5,196 ---------------------------------------- Current assets Inventories 37 26 Trade receivables 110 7 Government subsidies receivable 770 531 Other current assets 959 757 Prepaid expenses 388 154 Cash and Cash equivalents 67,405 77,477 ---------------------------------------- Total current assets 69,669 78,952 ---------------------------------------- ---------------------------------------- TOTAL ASSETS 74,509 84,147 ---------------------------------------- EQUITY AND LIABILITIES Common shares 14,593 14,579 Other reserves 51,331 59,975 ---------------------------------------- Total Equity 65,924 74,554 ---------------------------------------- Non-current liabilities Other contingencies and 4,723 4,618 liabilities Deferred income tax liabilities - 8 Financial Lease 108 114 ---------------------------------------- Total non current liabilities 4,831 4,740 ---------------------------------------- Current liabilities Other contingencies and 90 667 liabilities Financial lease 43 43 Trade payables 1,576 1,850 Social security and other taxes 1,968 2,145 Other liabilities 77 149 ---------------------------------------- Total current liabilities 3,754 4,853 ---------------------------------------- ---------------------------------------- TOTAL EQUITY AND LIABILITIES 74,509 84,147 ----------------------------------------

Nicox First Half 2013 Financial Results and Business Update:

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Nicox Contacts

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Tel +33 (0)4 97 24 53 00
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