NICOX
Paris : COX

May 04, 2011 09:18 ET

NicOx reports first quarter 2011 financial results

SOPHIA ANTIPOLIS CEDEX, FRANCE--(Marketwire - May 4, 2011) - NicOx S.A. (NYSE Euronext Paris: COX) today reported financial results for the first three months of 2011 and provided an overview of its activities.

Financial summary

Following the restructuring of the Group's entities and activities, research and development costs and administrative and selling costs were EUR4.2 million in the first quarter of 2011, compared to EUR16.2 million in the first quarter of 2010.

In the first quarter of 2011, NicOx recorded a total net loss for the period of EUR4.1 million, compared to EUR7.2 million for the first quarter of 2010. On March 31, 2011, the Company had cash and cash equivalents totaling EUR100.5 million, compared to EUR107.3 million on December 31, 2010.

No revenues were recorded for the first three months ended March 31, 2011, compared to EUR7.4 million for the same period of 2010, which related to the initial license payment received from Bausch + Lomb as part of the worldwide licensing agreement signed in March 2010.

Eric Castaldi, Chief Financial Officer of NicOx, commented: "We are committed to preserving our strong cash position, with cash and cash equivalents totaling EUR100.5 million as of March 31, 2011. As anticipated, following the restructuring implemented in the end of 2010, our expenses for the first quarter of this year show a significant reduction compared to the same period last year."

Operational summary

NicOx withdrew the Marketing Authorization Application (MAA) for naproxcinod in Europe in April 2011, following feedback that the Committee for Medicinal Products for Human Use (CHMP) would not adopt a formal positive opinion on the basis of the submitted information.

This withdrawal does not affect the option agreement which was signed in March 2011 with Grupo Ferrer Internacional S.A. allowing Ferrer to take exclusive distribution rights for NicOx's osteoarthritis candidate naproxcinod in Greece and Portugal and co-marketing rights in Spain and Germany following any potential future approval of naproxcinod in Europe. NicOx and Ferrer are working to evaluate the options available for the potential further development of naproxcinod in Europe.

NicOx decided to appeal the U.S. Food and Drug Administration (FDA) decision not to approve naproxcinod under the FDA's Formal Dispute Resolution process and is currently finalizing the submission of the supporting information for the appeal.

In March 2010, NicOx and Bausch + Lomb signed a Worldwide Licensing Agreement granting Bausch + Lomb exclusive rights to develop and commercialize BOL- 303259- X (NCX 116), an NO-donating prostaglandin F2-alpha analog for the potential treatment of glaucoma and ocular hypertension. In April 2011, Bausch + Lomb and NicOx agreed to restructure the terms of the future potential milestone payments, which could now total up to $172.5 million.

The Company has set out the following strategic priorities: evaluating products and companies to acquire; seeking new R&D alliances for certain R&D programs; continuing research in the most promising areas; evaluating options for naproxcinod in Europe with the assistance of Ferrer and finalizing the submission of the supporting information for the FDA appeal.

Review of the consolidated financial results for the three months ended March 31, 2011 and 2010

Revenues

NicOx did not record any revenues for the first three months ended March 31, 2011 compared to EUR7.4 million for the same period of 2010.

The revenues recognized during the first quarter of 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 has been 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, administrative and selling costs

Research and development costs, and administrative and selling costs for the first quarter of 2011 were significantly reduced as compared with that of 2010; amounting to EUR4.2 million for 2011, compared to EUR16.2 million for 2010. This significant reduction results from the restructuring of the Group's entities and activities following the decision of the FDA not to approve the marketing application for naproxcinod in the US in July 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 heavily redefined in order to protect the Company's cash and cash equivalents and refocus the Group's key strategic priorities.

As of March 31, 2011, 66% of these expenses concerned research and development expenses and 34% administrative and selling expenses, compared to 76% and 24%, respectively, in the first quarter 2010.

Research and development expenses totaled EUR2.8 million during the first quarter of 2011, compared to EUR12.3 million during the first quarter 2010. In the first quarter of 2011, research and development expenses correspond mainly to personnel expenses related to the activities performed in relation with the naproxcinod Marketing Authorization Application submitted in Europe. The Group employed 41 people in research and development on March 31, 2011, compared to 80 people at the same date in 2010.

Administrative expenses totaled EUR1.0 million in the first quarter of 2011 compared to EUR1.6 million in the first quarter of 2010 and include personnel expenses in administrative and financial functions, as well as the remuneration of corporate officers. Selling expenses were EUR0.4 million during the first three months ended March 31, 2011 compared to EUR2.2 million during the same period in 2010, and correspond for 2011 to the business development and communication activities of the Company. In 2010, these expenses also included the preparation of the then expected potential future commercialization of naproxcinod in the United-States. The Group employed 16 people in its selling and administrative departments on March 31, 2011, compared to 46 people on March 31, 2010.

Other income

During the first quarter of 2011, other income totaled EUR0.3 million compared to EUR1.8 million in the first quarter of 2010. Other income corresponds mainly to the operational subsidies from the research tax credit in France.

Other expense

Other expense, which concerns exclusively restructuring costs, was EUR0.3 million in the first quarter of 2011.

Operating results

The operating loss amounted to EUR4.2 million in the first three months ended March 31, 2011, compared to EUR7.0 million in the first quarter of 2010.

Other results

Net financial income amounted to EUR0.2 million during the first quarter of 2011, compared to EUR0.1 million during the same period in 2010, and represents mainly the returns on the financial investments of the Company's cash and cash equivalents.

The income tax expense incurred by NicOx during the first three months of 2011 relates principally to tax from its Italian subsidiary and totaled EUR0.05 million, compared to EUR0.2 million during the first quarter of 2010.

Total net loss for the period

The total net loss was EUR4.1 million for the first three months ended March 31, 2011, compared to EUR7.2 million during the same period in 2010. This decrease is explained by the significant reduction of 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 March 31, 2011, the Company's current liabilities totaled EUR5.2 million, including EUR1.7 million in other contingencies and liabilities with respect to the restructuring cost accrued, EUR1.7 million in accounts payable to suppliers and external collaborators, EUR0.9 million in accrued compensation for employees, EUR0.8 million in taxes payable and EUR0.1 million for other liabilities.

On March 31, 2011, the Company's cash and cash equivalents were EUR100.5 million, compared to EUR107.3 million on December 31, 2010 and EUR138.5 million on March 31, 2010. In late 2009, the Company completed a two step capital increase and received a total of EUR94.6 million corresponding to the net proceeds of the following operations: EUR29.4 million from a private placement of shares to institutional investors completed on November 23, 2009, and EUR65.2 million from a rights issue completed on December 23, 2009.

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 B: Mid 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 4th chapter of the « Document de référence, rapport financier annuel et rapport de gestion 2010 » filed with the French Autorité des Marchés Financiers (AMF) on February 25, 2011 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, 2011

+--------------------------------------+-+-------------------------------+
|                                      | |For the period of three months |
|                                      | |      ended of March 31,       |
+--------------------------------------+-+-------+-+---------------------+
|                                      | | 2011  | |        2010         |
+--------------------------------------+-+-------+-+---------------------+
|                                      | | (in thousands of EUR except   |
|                                      | |      for  per share data)     |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Revenues                              | |   -   | |        7,423        |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Research and development              | |       | |                     |
|expenses                              | |(2,7740| |      (12,331)       |
+--------------------------------------+-+-------+-+---------------------+
|Administrative expenses               | |(1,037)| |       (1,627)       |
+--------------------------------------+-+-------+-+---------------------+
|Selling expenses                      | | (423) | |       (2,230)       |
+--------------------------------------+-+-------+-+---------------------+
|Other income                          | |  320  | |        1,753        |
+--------------------------------------+-+-------+-+---------------------+
|Other expense                         | | (255) | |          -          |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Operating loss                        | |(4,169)| |       (7,012)       |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Finance income                        | |  173  | |         93          |
+--------------------------------------+-+-------+-+---------------------+
|Finance expense                       | | (12)  | |        (34)         |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Loss before income tax                | |(4,008)| |       (6,953)       |
+--------------------------------------+-+-------+-+---------------------+
|Income tax expense                    | | (52)  | |        (213)        |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Net loss of the period                | |(4,060)| |       (7,166)       |
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Exchange differences on translation   | |  34   | |         12          |
|of foreign operations                 | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Other comprehensive income (loss) for | |       | |                     |
|the period, net of tax                | |  34   | |         12          |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Total comprehensive income (loss) for | |(4,026)| |       (7,154)       |
|the period, net of tax                | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Attributable to:                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|- Equity holders of the parent        | |(4,026)| |       (7,154)       |
+--------------------------------------+-+-------+-+---------------------+
|- Non-controlling interests           | |   -   | |          -          |
+--------------------------------------+-+-------+-+---------------------+
|                                      | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+
|Basic and diluted loss per share      | |(0.06) | |       (0.10)        |
|attributable to equity holders of the | |       | |                     |
|parent                                | |       | |                     |
+--------------------------------------+-+-------+-+---------------------+

Interim consolidated Statement of Financial Position - March 31, 2011

+---------------------------------------------------+---------+----------+
|                                                   |  As of  |  As of   |
|                                                   |March 31,| December |
|                                                   |  2011   |   31,    |
|                                                   |         |   2010   |
+---------------------------------------------------+---------+----------+
|                                                   (in thousands of EUR)|
+---------------------------------------------------+---------+-+--------+
|ASSETS                                             |         | |        |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|Non-current assets                                 |         | |        |
+---------------------------------------------------+---------+-+--------+
|Property, plant & equipment                        |  1,964  | | 2,130  |
+---------------------------------------------------+---------+-+--------+
|Intangible assets                                  |   342   | |  386   |
+---------------------------------------------------+---------+-+--------+
|Other financial assets                             |   243   | |  247   |
+---------------------------------------------------+---------+-+--------+
|Deferred income tax assets                         |    6    | |   39   |
+---------------------------------------------------+---------+-+--------+
|Total non-current assets                           |  2,555  | | 2,802  |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|Current assets                                     |         | |        |
+---------------------------------------------------+---------+-+--------+
|Government subsidies receivable                    |  1,806  | | 1,509  |
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|Other current assets                               |   745   | |  909   |
+---------------------------------------------------+---------+-+--------+
|Prepaid expenses                                   |   668   | |  377   |
+---------------------------------------------------+---------+-+--------+
|Cash and cash equivalents                          | 100,543 | |107,335 |
+---------------------------------------------------+---------+-+--------+
|Total current assets                               | 103,762 | |110,130 |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|TOTAL ASSETS                                       | 106,317 | |112,932 |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|EQUITY AND LIABILITIES                             |         | |        |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|Common shares                                      | 14,538  | | 14,509 |
+---------------------------------------------------+---------+-+--------+
|Other reserves                                     | 81,925  | | 85,979 |
+---------------------------------------------------+---------+-+--------+
|Non-controlling interests                          |    -    | |   -    |
+---------------------------------------------------+---------+-+--------+
|Total Equity                                       | 96,463  | |100,488 |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|Non-current liabilities                            |         | |        |
+---------------------------------------------------+---------+-+--------+
|Other contingencies and liabilities                |  4,523  | | 4,548  |
+---------------------------------------------------+---------+-+--------+
|Deferred income tax liabilities                    |   98    | |   96   |
+---------------------------------------------------+---------+-+--------+
|Finance lease                                      |   76    | |   83   |
+---------------------------------------------------+---------+-+--------+
|Total non-current liabilities                      |  4,697  | | 4,727  |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|Current liabilities                                |         | |        |
+---------------------------------------------------+---------+-+--------+
|Other contingencies and liabilities                |  1,654  | | 2,800  |
+---------------------------------------------------+---------+-+--------+
|Finance lease                                      |   30    | |   30   |
+---------------------------------------------------+---------+-+--------+
|Trade payables                                     |  1,679  | | 2,045  |
+---------------------------------------------------+---------+-+--------+
|Social security and other taxes                    |  1,670  | | 2,627  |
+---------------------------------------------------+---------+-+--------+
|Other liabilities                                  |   124   | |  215   |
+---------------------------------------------------+---------+-+--------+
|Total current liabilities                          |  5,157  | | 7,717  |
+---------------------------------------------------+---------+-+--------+
|                                                   |         | |        |
+---------------------------------------------------+---------+-+--------+
|TOTAL EQUITY AND LIABILITIES                       | 106,317 | |112,932 |
+---------------------------------------------------+---------+-+--------+


NicOx reports first quarter 2011 financial results: http://hugin.info/143509/R/1512020/447447.pdf




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Source: NICOX via Thomson Reuters ONE

[HUG#1512020]

Contact Information

  • CONTACTS

    NicOx

    Gavin Spencer
    Vice President Business Development
    Tel +33 (0)4 97 24 53 00
    Email Contact

    www.nicox.com

    Media Relations

    Financial Dynamics

    Europe
    Guillaume Granier (France)
    Tel: +33 (0)1 47 03 68 10
    Email Contact
    Stéphanie Bia (France)
    Tel: +33 (0)1 47 03 68 10
    Email Contact
    Jonathan Birt (UK)
    Tel : +44 (0)20 7269 7205
    Email Contact

    United States
    Robert Stanislaro
    Tel: +1 212 850 5657
    Email Contact
    Irma Gomez-Dib
    Tel: +1 212 850 5761
    Email Contact

    NicOx S.A.
    Les Taissounières - Bât 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 9