SOURCE: NICOX
SOPHIA ANTIPOLIS, FRANCE–(Marketwire – July 30, 2010) – www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today reported its financial results
for the six months ended June 30, 2010 and provided a business update on
its activities.
Michele Garufi, Chairman and CEO of NicOx, declared: “This has been both an
active and a challenging first half for NicOx, as we worked with regulators
in the United States and Europe on the marketing applications for
naproxcinod. We will collaborate closely with both regulatory authorities
in the coming months. We will also focus on securing potential licensing
agreements for naproxcinod in Europe and the rest of the world, ensuring
the continued success of our existing partnerships and prioritizing our
research programs. We will continue to manage our cash resources in the
most cost-effective manner to ensure the future growth of the Company
whilst also pursuing appropriate in-licensing and M&A opportunities.”
Key events of the first six months of 2010:
– NicOx and Bausch + Lomb signed a Worldwide Licensing Agreement for the
glaucoma candidate NCX 116
– The European Medicines Agency (EMA) validated the Marketing Authorization
Application (MAA) for naproxcinod
– Joint Advisory Committee of the U.S. Food and Drug Administration (FDA)
voted that they did not have sufficient evidence to support the approval of
naproxcinod for the relief of the signs and symptoms of osteoarthritis
– Additional clinical data for naproxcinod and preclinical results for NCX
434 and NCX 1236, two of the Company’s nitric oxide (NO)-donating New
Molecular Entities, were presented at scientific and medical conferences
– NicOx and TOPIGEN Pharmaceuticals Inc. mutually terminated their
collaboration for TPI 1020 as a result of the acquisition of TOPIGEN
Post reporting period:
– On July 22, 2010, NicOx announced the receipt of a Complete Response
Letter from the U.S. Food and Drug Administration (FDA), stating that it
could not approve the New Drug Application (NDA) for naproxcinod. NicOx
plans on discussing the Complete Response Letter and potential next steps
with the FDA, as early as possible.
Eric Castaldi, Chief Financial Officer of NicOx, declared: “NicOx has a
strong cash position, with no long-term debt and cash and cash equivalents
totaling ?128.4 million at the end of June 2010. We will continue to
ensure careful conservation of our funds.”
Financial summary for the first half of 2010:
Revenues for the first half of 2010 were ?7.4 million, compared to
?1.1 million during the same period in 2009. These revenues correspond
to the initial license payment received from Bausch + Lomb in the first
quarter of the year, as per the agreement signed in March 2010.
For the first six months of 2010, operating expenses were ?36.4
million, compared to ?32.7 million for the same period in 2009. These
expenses correspond principally to personnel costs related to the
regulatory processes for naproxcinod both in the United States and in
Europe, investments in naproxcinod’s supply chain and costs related to the
anticipated cancellation of certain manufacturing and pre-commercial
activities following the decision of the FDA.
NicOx recorded a total net loss for the period of ?27.5 million for
the first six months of 2010, compared to a corresponding net loss of
?27.2 million for the same period in 2009. On June 30, 2010, NicOx had
cash and cash equivalents of ?128.4 million, compared to ?148.3
million on December 31, 2009.
Review of the first six months of 2010:
Signature of a Worldwide Licensing Agreement with Bausch + Lomb
In March 2010, NicOx and Bausch + Lomb signed a Worldwide Licensing
Agreement granting Bausch + Lomb exclusive rights to develop and
commercialize NCX 116, an NO-donating prostaglandin F2-alpha analog for the
potential treatment of glaucoma and ocular hypertension. Both companies
have already held an initial meeting to agree on the next steps for the
development of NCX 116. Under the terms of this agreement, NicOx received
an initial license payment of $10 million and stands to receive potential
milestones totaling $169.5 million, as well as tiered double-digit
royalties on the sales of NCX 116.
Regulatory status of naproxcinod in the United States
A Joint Advisory Committee of the FDA, including the Arthritis Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee, voted by 16 to 1 with 1 abstention on May 12, 2010 that they did
not have sufficient evidence at that time to support the approval of
naproxcinod for the relief of the signs and symptoms of osteoarthritis.
On July 22, 2010, NicOx announced the receipt of a Complete Response Letter
from the U.S. Food and Drug Administration (FDA) related to the New Drug
Application (NDA) for naproxcinod. The FDA informed NicOx that its review
of the NDA was complete and that it did not approve the naproxcinod
application. The FDA recommended conducting one or more long-term
controlled studies to assess the cardiovascular and gastrointestinal safety
of naproxcinod. Additional studies to demonstrate a clinically meaningful
therapeutic benefit attributable to the nitric oxide donation were also
recommended. No clinical efficacy studies were requested. NicOx plans to
discuss the Complete Response Letter and potential next steps as early as
possible with the FDA.
Regulatory status of naproxcinod in Europe
In January 2010, the European Medicines Agency (EMA) validated the
Marketing Authorization Application (MAA) for naproxcinod, which was
submitted through the centralized procedure in December 2009. NicOx is
seeking approval for an indication for the relief of the signs and symptoms
of primary osteoarthritis. The Medicinal Products for Human Use (CHMP)
opinion is expected by mid-2011, the exact timing depending on the
interactions needed with the health authorities in the last phase of the
review process.
Presentation of scientific results for naproxcinod
Detailed results from the 301 study were published in the May issue of
Osteoarthritis and Cartilage. Additional clinical data for naproxcinod were
presented in May at the American Society of Hypertension Annual Scientific
Meeting and Exposition in New York and in June at the European Meeting on
Hypertension in Olso and the Annual European Congress of Rheumatology in
Rome.
Presentation of promising preclinical results in international conferences
Preclinical results obtained with two of NicOx’s NO-donating New Molecular
Entities (NMEs) were presented in congresses in the first half of 2010. In
May, preclinical findings obtained with NCX 1236, a lead compound for the
potential treatment of Neuropathic Pain, were presented at the
International Congress on Neuropathic Pain in Athens. Preclinical results
for NCX 434, a potential preclinical candidate in Diabetic Macular Edema
(DME), were presented in May at the Ocular Diseases & Drug Discovery
conference in Boston and in June at the Retina International World Congress
in Stresa.
Review of the consolidated financial results for the six months ended June
30, 2010 and 2009:
Revenues
NicOx’s revenues totaled ?7.4 million for the six months ended June
30, 2010 compared to ?1.1 million for the six months ended June 30,
2009.
This significant increase results from the recognition as revenues during
the first quarter of 2010 of ?7.4 million corresponding 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 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
subject of this collaboration agreement. No revenues have been recorded in
the second quarter of 2010.
Operating expenses
For the six months ended June 30, 2010, operating expenses totaled
?36.4 million, compared to ?32.7 million for the six months ended
June 30, 2009, of which, 74% was attributable to research and development
expenses and 26% attributable to selling and administrative expenses in the
first semester of 2010, compared to 77% and 23% respectively in the first
semester of 2009.
Research and development expenses were ?26.9 million during the first
semester of 2010, compared to ?25.1 million during the first semester
of 2009 (including ?0.1 million allocated to cost of sales in 2009
corresponding to the expenses incurred by NicOx in performing research
activities under the contract signed with Pfizer). In the first semester of
2010, research and development expenses correspond principally to personnel
expenses related to the activities performed in relation with the
naproxcinod New Drug Application and Marketing Authorization Application
submitted respectively in the US and in Europe and to investment expenses
in dedicated manufacturing facilities of its active ingredient supplier DSM
in order to increase the naproxcinod supply chain capacity and flexibility.
Following the decision in July 2010 of the FDA not to approve the marketing
application for naproxcinod in the US, indemnities in an amount of
?6.9 million have been booked as research and development expenses in
the accounts as of June 30, 2010, to be paid to suppliers involved in the
manufacturing of naproxcinod for the anticipated cancellation of purchase
orders. The Company employed 79 people in research and development on June
30, 2010, compared to 93 people at the same date in 2009.
General and administrative expenses were ?3.2 million in the first
semesters of 2010 and 2009 and include personnel expenses in administrative
and financial functions, as well as the remuneration of corporate officers,
including stock option, free share and warrant attributions. Selling and
corporate development expenses totaled ?6.2 million during the first
six months ended June 30, 2010 compared to ?4.4 million during the
same period in 2009 and correspond to market research and analysis
activities for naproxcinod, as well as the business development and
communication activities of the Company. The Company employed 48 people in
its selling, general and administrative departments on June 30, 2010,
compared to 39 people on June 30, 2009.
Other income
Other income totaled ?1.6 million during the first semester of 2010
compared to ?3.1 million in the first semester of 2009. Other income
corresponds mainly to the operational subsidies from the research tax
credits in France and in Italy.
Operating result
The operating loss amounted to ?27.4 million in the six months ended
June 30, 2010, compared to ?28.5 million in the same period in 2009.
Other results
Net financial income totaled ?0.1 million during the first semester of
2010, compared to ?1.3 million during the first semester of 2009, and
represents mainly the returns on the financial investments of the Company’s
cash, cash equivalents.
The income tax expense incurred by NicOx during the first six months of
2010 relates to tax from its US and Italian subsidiaries and totaled
?0.3 million, compared to ?0.1 million during the same period in
2009.
Total net loss of the period
The total net loss for the period was ?27.5 million on June 30, 2010,
compared to ?27.2 million on June 30, 2009. Notwithstanding the strong
increase of the revenues recognized in the first six months of 2010
following the initial license payment received from Bausch + Lomb, the
total net loss on June 30, 2010 remains at the same level as last year due
to the impact of the anticipated cancellation of manufacturing and pre-
commercial activities related to naproxcinod following the decision of the
FDA not to approve the application of the product in the United States.
Consolidated statement of financial position
The indebtedness incurred by NicOx is mainly short-term operating debt. On
June 30, 2010, the Company’s current liabilities totaled ?16.6
million, including ?12.0 million in accounts payable to suppliers and
external collaborators (including ?5.9 million with respect to the
cancellation of orders of naproxcinod active drug substance), ?2.5
million in accrued compensation for employees, ?1.9 million in other
contingencies and liabilities (corresponding to the costs related to the
anticipated cancellation of certain manufacturing and pre-commercial
activities following the decision of the FDA) and ?0.2 million for
other liabilities.
The Company’s cash and cash equivalents were ?128.4 million on June
30, 2010, compared to ?148.3 million on December 31, 2009, and
?76.8 million on June 30, 2009. In late 2009, the Company completed a
two step capital increase and received a total of ?94.6 million
corresponding to the net proceeds of the following operations: ?29.4
million from a private placement of shares to institutional investors
completed on November 23, 2009, and ?65.2 million from a rights issue
completed on December 23, 2009.
NicOx will continue to pursue the European regulatory process for
naproxcinod and follow-up with the FDA after the Complete Response Letter.
NicOx will actively seek to enter into partnerships for naproxcinod. The
Company’s cash position is strong and NicOx is taking all necessary steps
to preserve it.
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 2009 ”
filed with the French Autorité des Marchés Financiers (AMF) on
March 5, 2010 and available on NicOx’s website (www.nicox.com) and on the
AMF’s website (www.amf-france.org).
The Company notably draws the investors’ attention to the following risk
factors:
– Risques liés à la dépendance de la Société
à l’égard du naproxcinod (Risks related to the Company’s
dependence on the success of its lead product naproxcinod)
– Risques commerciaux et développements cliniques (Clinical
developments and commercial risk)
– Risques liés aux contraintes réglementaires et à la
lenteur des procédures d’approbation (Risks linked to regulatory
constraints and slow approval procedures)
– Manque de capacités dans les domaines de la vente et du marketing
(Lack of sales and marketing capabilities)
– Incertitude relative aux prix des médicaments et aux régimes de
remboursement, ainsi qu’en matière de réforme des régimes
d’assurance maladie (Uncertainty on drug pricing and reimbursement policies
and on the reforms of the health insurance systems)
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 (NME)
for the potential treatment of inflammatory, cardio-metabolic and
ophthalmological diseases.
NicOx’s lead investigational compound is naproxcinod, an NME and a first-
in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-
inflammatory drug candidate developed for the relief of the signs and
symptoms of osteoarthritis (OA). In July 2010, the U.S. Food and Drug
Administration (FDA) provided a Complete Response Letter to the New Drug
Application (NDA) for naproxcinod stating that it does not approve the
naproxcinod application. The naproxcinod Marketing Authorization
Application (MAA) submitted by NicOx in December 2009 is currently under
review by the European Medicines Agency (EMA).
In addition to naproxcinod, NicOx’s pipeline includes several nitric oxide-
donating NMEs, which are in development internally and with partners,
including Merck & Co., Inc. and Bausch + Lomb, for the treatment of
hypertension, cardiometabolic diseases, eye diseases and dermatological
diseases.
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. For a discussion of
risks and uncertainties which could cause actual results, financial
condition, performance or achievements of NicOx S.A. to differ from those
contained in the forward-looking statements, please refer to the Risk
Factors (“Facteurs de Risque”) section of the Document de Reference filed
with the AMF, which is available on the AMF website (http://www.amf-
france.org) or on NicOx S.A.’s website (http://www.nicox.com).
+-------------------------+-+--------------------+-+---------+ | | |For the period ended| | | | | |June 30, | | | +-------------------------+-+--------------------+-+---------+ | | |2010 | | 2009 | +-------------------------+-+--------------------+-+---------+ | | |(in thousands of EUR| | | | | |except for per share| | | | | |data) | | | +-------------------------+-+--------------------+-+---------+ |Revenues | |7,423 | | 1,119 | | | | | | | +-------------------------+-+--------------------+-+---------+ |Cost of sales | |- | | (75) | | | | | | | | | | | | | | | | | | | +-------------------------+-+--------------------+-+---------+ |Research and development | |(26,924) | |(25,031) | |expenses | | | | | +-------------------------+-+--------------------+-+---------+ |Administrative expenses | |(3,214) | | (3,234) | | | | | | | +-------------------------+-+--------------------+-+---------+ |Selling expenses | |(6,241) | | (4,403) | | | | | | | +-------------------------+-+--------------------+-+---------+ |Other income | |1,600 | | 3,130 | | | | | | | +-------------------------+-+--------------------+-+---------+ |Operating loss | |(27,356) | |(28,494) | | | | | | | +-------------------------+-+--------------------+-+---------+ |Finance income | |183 | | 1 388 | | | | | | | +-------------------------+-+--------------------+-+---------+ |Finance expense | |(70) | | (54) | | | | | | | +-------------------------+-+--------------------+-+---------+ |Loss before income tax | |(27,243) | |(27,160) | | | | | | | | | | | | | | | | | | | +-------------------------+-+--------------------+-+---------+ |Income tax expense | |(257) | | (77) | | | | | | | +-------------------------+-+--------------------+-+---------+ |Net loss of the | |(27,500) | |(27,237) | |period | | | | | +-------------------------+-+--------------------+-+---------+ |Exchange differences on | |(38) | | (1) | |translation of foreign | | | | | |operations | | | | | +-------------------------+-+--------------------+-+---------+ |Other comprehensive | |(38) | | (1) | |income (loss) for the | | | | | |period, net of tax | | | | | +-------------------------+-+--------------------+-+---------+ |Total comprehensive | |(27,538) | |(27,238) | |income (loss) for the | | | | | |period, net of tax | | | | | +-------------------------+-+--------------------+-+---------+ |Attributable to: | | | | | +-------------------------+-+--------------------+-+---------+ |- Equity holders of the | |(27,538) | |(27,238) | |parent | | | | | | | | | | | | | | | | | +-------------------------+-+--------------------+-+---------+ |- Non-controlling | |- | | - | |interests | | | | | | | | | | | | | | | | | +-------------------------+-+--------------------+-+---------+ |Basic and diluted loss | |(0.38) | | (0.57) | |per share attributable to| | | | | |equity holders of the | | | | | |parent | | | | | +-------------------------+-+--------------------+-+---------+
+----------------------+--------------------+-+------------------+--------+ | | June 30, 2010 | |December 31, 2009 | | +----------------------+--------------------+-+------------------+--------+ | |(in thousands | | | | | | of EUR) | | | | +----------------------+--------------------+-+------------------+--------+ |ASSETS | | | | | +----------------------+--------------------+-+------------------+--------+ |Non-current assets | | | | | +----------------------+--------------------+-+------------------+--------+ |Property, plant & | 2,782 | | | 2,772 | |equipment | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Intangible assets | 794 | | | 797 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Government subsidies | 936 | | | 477 | |receivable | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Other financial assets| 267 | | | 238 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Deferred income tax | - | | | 156 | |assets | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Total non-current | 4,779 | | | 4,440 | |assets | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Current assets | | | | | +----------------------+--------------------+-+------------------+--------+ |Government subsidies | 3,263 | | | 2,597 | |receivable | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Other current assets | 988 | | | 1,329 | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Prepaid expenses | 1,213 | | | 784 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Cash and cash | 128,448 | | |148,275 | |equivalents | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Total current assets | 133,912 | | |152,985 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |TOTAL ASSETS | 138,691 | | |157,425 | +----------------------+--------------------+-+------------------+--------+ |EQUITY AND LIABILITIES| | | | | +----------------------+--------------------+-+------------------+--------+ |Common shares | 14,505 | | | 14,434 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Other reserves | 103,046 | | |128,444 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Non-controlling | - | | | - | |interests | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Total Equity | 117,551 | | |142,878 | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Non-current | | | | | |liabilities | | | | | +----------------------+--------------------+-+------------------+--------+ |Other contingencies | 4,369 | | | 4,069 | |and liabilities | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Deferred income tax | 98 | | | 91 | |liabilities | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Finance lease | 44 | | | 6 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Total non-current | 4,511 | | | 4,166 | |liabilities | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Current liabilities | | | | | +----------------------+--------------------+-+------------------+--------+ |Other contingencies | 1,890 | | | - | |and liabilities | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Finance lease | 18 | | | 7 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Trade payables | 12,034 | | | 6,136 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Current income tax | - | | | 19 | |payable | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Social security and | 2,504 | | | 3,909 | |other taxes | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Other liabilities | 183 | | | 310 | | | | | | | | | | | | | | | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |Total current | 16,629 | | | 10,381 | |liabilities | | | | | | | | | | | +----------------------+--------------------+-+------------------+--------+ |TOTAL EQUITY AND | 138,691 | | |157,425 | |LIABILITIES | | | | | +----------------------+--------------------+-+------------------+--------+ |NicOx S.A., | | | | | +----------------------+--------------------+-+------------------+--------+ |Les Taissounières-Bât | | | | | |HB4 - 1681 route des | | | | | |Dolines - BP313, 06906| | | | | |Sophia Antipolis cedex| | | | | |France. | | | | | |Tel. | | | | | |+33 (0)4 9724 53 00 | | | | | |Fax | | | | | |+33 (0)497 24 53 99 | | | | | +----------------------+--------------------+-+------------------+--------+ +----------------------+--------------------+-+------------------+--------+
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