SOPHIA ANTIPOLIS CEDEX, FRANCE--(Marketwire - July 27, 2012) - NicOx S.A. (EURONEXT: COX)
(PARIS: COX) today reports financial results for the
six 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 innovative
in the ocular field, including AdenoPlus™
* Management team strengthened with the appointments of Jerry St. Peter
United States and Philippe Masquida in Europe
* Positive phase 2b results observed with glaucoma candidate
Bausch + Lomb to move compound into phase 3 development program
* 11.8% investment in Altacor, a privately-held ophthalmology company
the United Kingdom
"During the first six months of 2012, NicOx made significant
delivering its strategy of becoming an international, late-stage
commercial ophthalmology player," said Michele Garufi, Chairman and
NicOx. "We achieved the first step through the acquisition of worldwide
to a promising portfolio of ocular diagnostic products from RPS®. We
launch AdenoPlus™, our first commercially available product, by the
2012 under the leadership of Jerry St. Peter in the US and Philippe
Europe. Discussions are advancing to further expand our product portfolio
US and in Europe through further acquisitions and in-licensing."
Eric Castaldi, Chief Financial Officer of NicOx, added: "We are
creating small, specialist sales teams in the US and Europe to
recently in-licensed AdenoPlus™ diagnostic test. As of June 30,
Company had cash and cash equivalents of more than EUR88 million, putting
us in a
good position to continue to invest in targeted commercial and
opportunities in ophthalmology."
Revenues were EUR7.5 million in the first half of 2012, compared to zero
corresponding period of 2011. This reflects a one-off $10 million
payment (corresponding to EUR7.5 million) received from Bausch + Lomb
2012, following its decision to continue the development of BOL-303259-X.
Research and development costs and administrative and selling costs
EUR8.1 million in the first half of 2012, compared to EUR8.8 million in
half of 2011.
NicOx recorded a total net loss of EUR0.4 million in the first half of
compared to a net loss of EUR7.8 million for the same period in 2011.
30, 2012, the Group had cash and cash equivalents totaling EUR88.5
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 a
agreement in June 2012, with effect from July 2012, granting NicOx
rights to unique point-of-care tests in the ocular field. AdenoPlus™,
easy-to-use diagnostic test for the in-office detection of
conjunctivitis, is already authorized for marketing in the US and in
Company expects to launch AdenoPlus™ in the US and in key European
by the end of 2012.
The worldwide licensing agreement also covers two additional diagnostic
currently in development as well as an exclusive worldwide option to
an agreement for an additional promising product, based on RPS®
certain milestones which include on-going external discussions.
Under the agreement, NicOx paid RPS® a total of $4 million in
option fees. The financial terms also include single-digit
potential additional milestone payments of up to $2 million. NicOx will
half of the development costs for the two development-stage products,
an 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 (NCX
patients with open-angle glaucoma or ocular hypertension met its
endpoint and showed promising results on a number of secondary endpoints.
+ Lomb will initiate a global phase 3 development program for
paid a $10 million milestone payment to NicOx (EUR7.5 million) in April
BOL-303259-X is a novel nitric oxide-donating prostaglandin F2 alpha analog
by 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 as
Vice President and General Manager of NicOx Inc., the U.S. subsidiary of
and Philippe Masquida as Executive Vice President, Managing Director of
Operations. Both Jerry St. Peter and Philippe Masquida have extensive
senior-level international experience, notably in the ophthalmology field.
Following the in-licensing of AdenoPlus™, which is already
marketing in the US and in Europe, NicOx is building up its
organization in the US and in Europe. The commercial teams will
commercialization of AdenoPlus™ and other ophthalmology products,
diagnostic and therapeutic, that the Company plans to acquire or
Investment in Altacor
In March 2012, NicOx acquired 11.8% of the shares of Altacor, a
ophthalmology company based in the United Kingdom. Altacor markets
a range of five products for dry eye, in the UK and Ireland. On May 31,
NicOx's Board of directors decided not to exercise an option to
remaining 88.2% of equity of Altacor. NicOx retains its 11.8% stake and
continue to support Altacor through the presence of Gavin Spencer,
Vice President, Corporate Development of NicOx as a member of Altacor's
Meeting with the FDA on April 3, 2012
NicOx met with the US Food and Drug Administration (FDA) on April 3,
discuss the proposed use of naproxcinod 375 mg twice daily (bid)
treatment of signs and symptoms of osteoarthritis (OA) of the knee,
proposed new NDA (New Drug Application) that would require additional
data prior to any such NDA submission.
Having assessed the requirements for further clinical data discussed
FDA and its impact on the overall development program of naproxcinod,
initiated the process of seeking a partner to fund and manage any
development and potential commercialization of naproxcinod.
NicOx had previously submitted an NDA for naproxcinod 375 mg bid and 750
for the treatment of signs and symptoms of OA not limited to the knee.
received a Complete Response Letter in July 2010 stating that the FDA
approve that naproxcinod NDA. NicOx initiated a Formal Dispute
process in July 2011 regarding that decision involving the previously
NDA. These were not the topic of the April 3, 2012 meeting.
Subject to NicOx finding a potential partner to pursue the
naproxcinod 375 mg bid in knee OA, if the Company moves forward with
NDA, the Company anticipates that the Formal Dispute Resolution
initiated 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-stage
commercial specialty ophthalmology company, the Board decided to
rationalize the Company's R&D pipeline and to discontinue any programs
non-core in view of the Company expansion in the ophthalmic space. As a
the Company will no longer pursue the development of NCX 6560, a new
entity for cardiovascular indications, or research programs
neuropathic pain (including NCX 1236) and pulmonary arterial
(including NCX 226).
The Company is evaluating various options to pursue the development
NO-donating compounds targeting eye conditions, including NCX 434 and NCX
Company may choose to develop these programs in-house or with a partner.
Review of the consolidated financial results for the six months ended
30, 2012 and 2011
The interim consolidated financial statements for the six months ended
30, 2012 and 2011 have been prepared in accordance with applicable
principles and a limited review has been performed by the auditors.
On March 21, 2012, NicOx acquired 11.8% of the shares of Altacor, a
privately-held ophthalmology company based in the United Kingdom, and,
into an exclusive option agreement to acquire the remaining shares of
shares and/or warrants, cash or a combination of cash and shares. Under
the Group was deemed to have the power to control Altacor as it had,
31, 2012, the option to acquire the remainder of Altacor's shares in
Therefore, on March 31, 2012 Altacor's transaction was considered a
combination in accordance with the above mentioned accountancy rules. In
context, NicOx has accounted for the combination of NicOx and Altacor
purchase method of accounting in accordance with IFRS 3,
On May 31, 2012 NicOx decided not to exercise the option to
remaining 88.2 % of equity of Altacor. Therefore, on June 30, 2012
deemed to have lost the power to control Altacor and in consequence has
all the assets and liabilities of Altacor as of May 31, 2012.
Nevertheless, under IFRS principles the Group is deemed to
significant influence over Altacor as a result of its participation in the
capital and Board of Directors of Altacor. Consequently, the
consolidated half-year financial statements for the six months to June 30,
include Altacor for the period from May 31 to June 30, 2012, on the basis
Consolidated statement of comprehensive income
For the six month ended June 30, 2012, NicOx revenues totaled EUR7.5
compared to zero revenue in the first semester of 2011.
The revenues recognized on June 30, 2012 correspond to the milestone
$10 million invoiced to Bausch + Lomb in March 2012, following their
continue the development of BOL-303259-X (NCX 116). This amount has
immediately recognized in revenues because the Company will not have
involvement in the future development of this compound which is the
the 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,
selling costs decreased to EUR8.1 million compared to EUR8.8 million for
semester of 2011. In 2010 and in 2011, NicOx implemented two
restructurings of its entities and activities. As part of the
2010, the US offices of NicOx were closed in August 2010, the headcount
French and Italian entities of the Group were significantly
activities were redefined in order to protect the Company's cash and
equivalents and refocus the Group's key strategic priorities. In the
quarter of 2011, the Group has implemented an additional reduction
workforce by approximately one third in order to align its structure
corporate strategy of becoming an international, late-stage
commercial ophthalmology Group. On June 30, 2012, 43% of these
concerned research and development expenses and 57% administrative and
expenses, compared to 60% and 40%, respectively, on June 30, 2011.
During the first semester of 2012, research and development expenses were
million, compared to EUR5.2 million during the same period in 2011. In
six months of 2012, research and development expenses primarily
activities at the research center and ongoing regulatory activities
naproxcinod. On June 30, 2012, the Group employed 19 people in
development, compared to 40 people at the same date in 2011.
Administrative expenses were EUR1.9 million in the first six months
compared to EUR2.6 million during the same period in 2011 and include
expenses in administrative and financial functions, as well as the
of corporate officers. Selling expenses totaled EUR3.0 million on June 30,
compared to EUR1.0 million in the first semester of 2011, and correspond
first six months of 2012 principally to communication and business
activities (including notably EUR0.7 million of costs incurred over the
relation with the acquisition of the 11.8% of Altacor). The Group
people in its selling and administrative departments on June 30, 2012,
to 16 people on June 30, 2011.
During the first six months of 2012, other income was EUR0.6 million
EUR0.5 million in the first semester of 2011. In 2012, other income
for EUR0.2 million to the operational subsidies from the research tax
France and for EUR0.4 million to an unrealized foreign exchange gain.
Other expense, which refers exclusively to restructuring costs, amounted to
million on June 30, 2012, compared to an income of EUR0.1 million
30, 2011. On June 30, 2012, the Group has accrued an amount of EUR0.9
respect to an undertaking vis-à-vis employees of the Italian
subsidiary in the
event of a potential further restructuring.
For the first six months of 2012 the Group generated an operating loss of
million, compared to an operating loss of EUR8.2 million during the same
In the first six months of 2012, net financial income totaled EUR0.1
(including the share of Altacor's results), compared to EUR0.4 million
first six months of 2011, and mainly represents the returns on the
investments of the Company's cash and cash equivalents.
The income tax expense incurred by NicOx during the first semester of
relates to tax from its Italian subsidiary and totaled EUR0.04 million,
to 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 compared
million on June 30, 2011. This significant decrease of the net loss in the
six months of 2012 is explained by the strong increase of the
recognized over the period as indicated above.
Consolidated statement of financial position
The indebtedness incurred by NicOx is mainly short-term operating debt. On
30, 2012, the Group's current liabilities totaled EUR5.2 million,
million in accounts payable to suppliers and external collaborators,
million in other contingencies and liabilities with respect to the
cost accrued, EUR1.0 million in taxes payable and EUR0.8 million
compensation for employees.
On June 30, 2012, the Group's cash and cash equivalents were EUR88.5
compared to EUR93.1 million on December 31, 2011.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating an international,
late-stage development and commercial ophthalmology group based around
diagnostics and devices.
NicOx has in-licensed innovative ocular diagnostics from RPS®,
AdenoPlus™, a test for the detection of adenoviral conjunctivitis
authorized for marketing in the United States and Europe. The Company
partnership with Bausch + Lomb for the development of BOL-303259-X, a
glaucoma candidate based on NicOx's proprietary nitric
Further nitric oxide-donating compounds are under development in
non-ophthalmology indications notably through partners, including Merck
MSD outside the United States and Canada) and Ferrer.
NicOx S.A. is headquartered in France and is listed on Euronext
(Compartment C: Small Caps).
This press release contains certain forward-looking statements.
Company believes its expectations are based on reasonable assumptions,
forward-looking statements are subject to numerous risks and
which could cause actual results to differ materially from those
the forward-looking statements.
Risks factors which are likely to have a material effect on NicOx's
presented in the 4th chapter of the « Document de référence,
annuel et rapport de gestion 2011 » filed with the French
Autorité des Marchés
Financiers (AMF) on February 29, 2012 and available on NicOx's
(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,
(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
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
- 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
Interim consolidated Statement of Financial Position - june 30, 2012
As of As of
June 30, December 31,
(in thousands of EUR)
Property, plant & 611 843
Intangible 99 117
Investments in associates and 2,317 -
Other financial assets 273 263
Deferred income tax 56 65
Total non-current 3,356 1,288
Government subsidies 1,087 866
Other current 795 367
Prepaid 334 172
Cash and cash 88,509 93,136
Total current 90,725 94,541
TOTAL ASSETS.................. 94,081 95,829
EQUITY AND LIABILITIES
Common 14,578 14,563
Other 69,58 69,761
Non-controlling - -
Total Equity 84,136 84,324
Other contegencies and 4,671 4,592
Deferred income tax 1 3
Finance 46 58
Total non-current 4,718 4,653
Other contingencies and 1,55 3,59
Finance 24 24
Trade payables .................. 1,793 1,185
Social security and other 1,782 1,89
Other 78 163
Total current 5,227 6,852
TOTAL EQUITY AND 94,081 95,829
NicOx first half 2012 financial results:
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