Press Release Source: NICOX On Thursday October 27, 2011, 1:44 am EDT
SOPHIA ANTIPOLIS, FRANCE–(Marketwire -10/27/11)-www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today reported financial results for the nine month period ended September 30, 2011, and provided an overview of its activities.
Financial summary for the first nine months of 2011
Following the restructuring of the Group’s entities and activities in late 2010, research and development costs and administrative and selling costs were EUR11.8 million in the nine months to September 30, 2011, compared to EUR41.4 million for the same period in 2010.
In the first nine months of 2011, NicOx recorded a total net loss for the period of EUR10.4 million, compared to EUR37.8 million for the first nine months of 2010. On September 30, 2011, the Company had cash and cash equivalents totalling EUR96.2 million, compared to EUR107.3 million on December 31, 2010.
No revenues were recorded for the nine months ended September 30, 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.
Third quarter operational summary
In July 2011, NicOx formally initiated the Food and Drug Administration’s (FDA) Formal Dispute Resolution process regarding the decision not to approve naproxcinod for the relief of the signs and symptoms of osteoarthritis in July 2010. This process enables companies to request a formal review of any FDA decision by raising the matter to the higher supervisory level. If the issue is not resolved at the primary supervisory level, the company may request that the matter be reviewed at additional supervisory levels. NicOx will update the market on the outcome of the appeal when the process is completed.
In August 2011, Jean-Luc Bélingard informed NicOx of his decision to step down from the Board of Directors because of his increased responsibilities at bioMérieux. M. Bélingard joined NicOx’s Board of Directors in 2002 and the Company would like to thank him for his invaluable support and advice during this period.
In September 2011, new preclinical results obtained with NCX 6560 were presented at the European Muscle Conference in Berlin (Germany), the annual meeting of the European Society for Muscle Research. NicOx also made several preclinical presentations at the 35(th) National Congress of the Italian Society of Pharmacology in Bologna (Italy) and at the Congress of the European Federation of IASP (International Association for the Study of Pain) Chapters in Hamburg (Germany).
The Company is continuing to work on implementing the previously disclosed business development strategy and to find innovative ways of securing alternative funding for early-stage projects to maximise the potential of its nitric oxide-donating platform.
Post-reporting period
NicOx and Ferrer Grupo have agreed to amend their collaboration for the development of NCX 1047, the lead preclinical candidate in their dermatology alliance, in order to enable NicOx to seek a development and marketing partner in the US. Ferrer will waive its option on US development and marketing rights to any product covered by the agreement, which was signed in April 2004((1)) and expanded in September 2005((2)). Ferrer retains marketing rights for the European Union (including the European Free Trade Association, EFTA), Latin America, French-speaking Africa (including Morocco and Algeria) and Egypt. NicOx retains all rights for Asia and has the right to co-market products directly in the European Union and EFTA.
Review of the consolidated financial results for the nine months ended September 30, 2011 and 2010:
Revenues
NicOx did not record any revenues for the nine months ended September 30, 2011, compared to EUR7.4 million for the same period of 2010.
The revenues recognized during the first nine months 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, general, administrative and selling costs
For the nine months ended September 30, 2011, research and development costs and general, administrative and selling costs were significantly reduced from the same period of 2010, amounting to EUR11.8 million compared to EUR41.4 million. 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. For the first nine months of 2011, 61% of these expenses were attributable to research and development and 39% to selling and administrative expenses compared to 74% and 26%, respectively, for the same period of 2010.
Research and development expenses were EUR7.2 million in the nine months ended September 30, 2011, compared to EUR30.8 million during the nine months ended September 30, 2010. In the first nine months of 2011, research and development expenses correspond mainly to personnel expenses. The Group employed 39 people in research and development on September 30, 2011, compared to 73 people at the same date in 2010.
In the first nine months of 2011, general and administrative expenses were EUR3.4 million compared to EUR3.9 million on September 30, 2010, and include personnel expenses in administrative and financial functions, as well as the remuneration of corporate officers. Selling expenses totaled EUR1.3 million during the nine months ended September 30, 2011, compared to EUR6.7 million during the same period 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-licence). In 2010, these expenses also included preparation for the potential future commercialization of naproxcinod in the United States. On September 30, 2011, the Group employed 18 people in its selling, general and administrative departments, compared to 30 people at the same date in 2010.
Other income
Other income was EUR0.8 million at September 30, 2011 compared to EUR2.0 million at September 30, 2010. Other income relates to operational subsidies from research tax credits in France.
Other expenses
Other expenses exclusively relate to restructuring costs. These resulted in an income of EUR0.1 million on September 30, 2011 due to the cancellation of contingencies related to the restructuring of NicOx S.A recognized in 2010, which are no longer applicable in 2011.
For 2010, other expenses included an accrual of EUR4.7 million corresponding to estimated costs for the restructuring plan for NicOx SA’s headquarters and Italian subsidiary; the cancellation of expenses in an amount of EUR1.4 million further to the cancellation of rights on stock options and free shares as a consequence of the restructuring plan and EUR2.5 million corresponding to the cost of the closure of the offices of NicOx Inc. in the US.
Operating result
The operating loss amounted to EUR10.9 million in the nine months ended September 30, 2011, compared to EUR37.7 million on September 30, 2010.
Other results
Net financial income totaled EUR0.7 million during the first nine months of 2011, compared to EUR0.2 million during the same period 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 the first nine months of 2011 relates to tax from its US and Italian subsidiaries and totaled EUR0.1 million, compared to EUR0.3 million during the same period in 2010.
Total net loss of the period
The total net loss was EUR10.4 million for the nine months ended September 30, 2011, compared to EUR37.8 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 September 30, 2011, the Company’s current liabilities totaled EUR4.4 million, including EUR1.2 million in accrued compensation for employees, EUR1.2 million in taxes payable, EUR1.0 million in accounts payable to suppliers and external collaborators, EUR0.8 million in other contingencies and liabilities with respect to the restructuring cost accrued and EUR0.2 million for other liabilities.
The Company’s cash and cash equivalents were EUR96.2 million on September 30, 2011, compared to EUR107.3 million on December 31, 2010 and EUR115.9 million on September 30, 2010.
(1) See NicOx press release dated April 29, 2004.
(2) See NicOx press release dated September 15, 2005.
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 4(th) 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).
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 99
Interim Consolidated statement of Comprehensive Income – September 30, 2011
For the period of nine months ended September 30, 2011 2010 (in thousands of EUR except for per share data) Revenues ...................... - 7,423 Research and development (7,160) (30,754) expenses............... Administrative expenses.................. (3,395) (3,940) Selling expenses..................... (1,279) (6,665) Other income......................... 764 2,020 Other expense...................... 141 (5,824) Operating loss ...................... (10,929) (37,740) Finance income ...................... 675 313 Finance expense...................... (12) (86) Loss before income tax (10,266) 37,513 Income tax expense....................... (94) (327) Net loss of the period................. (10,360) (37,840) Exchange differences on translation of - 15 foreign operations... Other comprehensive income (loss) for the - - period, net of tax Total comprehensive income (loss) for the (10,360) (37,825) period, net of tax Attributable to: - Equity holders of the parent (10,360) (37,825) - Non-controlling interests - - Basic and diluted loss per share attributable (0.14) (0.51) to equity holders of the parent......................
Interim consolidated Statement of Financial Position – September 30, 2011
As of As of September December 30, 31, 2011 2010 (in thousands of EUR) ASSETS Non-current assets Property, plant & equipment 1,682 2,130 Intangible assets 258 386 Other financial assets 254 247 Deferred income tax assets 6 39 Total non-current assets 2,200 2,802 Current assets Government subsidies receivable 764 1,509 Other current assets 636 909 Prepaid expenses 334 377 Cash and cash equivalents 96,156 107,335 Total current assets 97,890 110,130 TOTAL ASSETS 100,090 112,932 EQUITY AND LIABILITIES Common shares 14,563 14,509 Other reserves 76,127 85,979 Non-controlling interests . - - Total Equity 90,690 100,488 Non-current liabilities Other contingencies and liabilities 4,871 4,548 Deferred income tax liabilities 105 96 Finance lease 65 83 Total non-current liabilities 5,041 4,727 Current liabilities Other contingencies and liabilities 761 2,800 Finance lease 30 30 Trade payables 1,005 2,045 Social security and other taxes 2,391 2,627 Other liabilities 172 215 Total current liabilities 4,359 7,717 TOTAL EQUITY AND LIABILITIES 100,090 112,932
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 99
NicOx reports financial results for the nine months to September 2011:http://hugin.info/143509/R/1558194/481241.pdf
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Source: NICOX via Thomson Reuters ONE
[HUG#1558194]
Contact:
CONTACTS NicOx Gavin Spencer Vice President Business Development Tel +33 (0)4 97 24 53 00 Email Contact www.nicox.com Media Relations FTI Consulting Jonathan Birt Tel : +44 (0)20 7269 7205 Email Contact
