First half 2008 financial results: NicOx nears completion of phase 3 naproxcinod studies
SOURCE:
NICOX
2008-07-28 00:00:00
First half 2008 financial results: NicOx nears completion of phase 3 naproxcinod studies
SOPHIA ANTIPOLIS, FRANCE–(EMWNews – July 28, 2008) – July 28, 2008. Sophia Antipolis,
France. www.nicox.com
NicOx S.A. (Euronext Paris: COX) today reported its financial results for
the six months ended June 30, 2008.
Key highlights for the first six months of 2008:
– Completion of patient enrollment in the third naproxcinod pivotal phase 3
study (303)
– Post hoc analysis of Office Blood Pressure Measurements (OBPM) from the
naproxcinod 301 phase 3 study presented at EULAR, showing a statistically
significant difference between naproxcinod and naproxen in 3 out of 4
comparisons
– Initiation of two large Ambulatory Blood Pressure Monitoring (ABPM)
studies for naproxcinod in hypertensive patients with osteoarthritis, which
aim to provide complimentary data on naproxcinod’s blood pressure profile.
These studies have subsequently completed patient enrollment in July
– Agreement signed with Archimica Inc. for commercial manufacture of
naproxcinod drug substance
– Initiation of first clinical trial by Merck & Co., Inc. for an
investigational nitric oxide-donating agent in hypertensive volunteers
– Extension of the research agreement with Pfizer Inc, which covers NicOx’
proprietary technology in ophthalmology
– Announcement of the results of a U.S. phase 2 study for the nitric oxide-
donating prostaglandin analog PF – 03187207 and the decision by Pfizer not
to launch a global phase 3 development program for this compound
Michele Garufi, Chairman and CEO of NicOx, commented: “We remain focused on
finalizing our planned NDA submission for naproxcinod with the US FDA in
mid 2009. We are on track to achieve this important milestone with our two
ongoing phase 3 studies nearing completion. Our confidence in our lead
product has led us to sign an agreement with Archimica for the supply of
naproxcinod drug substance for our future commercial needs. Additionally,
we are proud of the relationships we have built with our pharmaceutical
partners, with Pfizer extending our ophthalmology research collaboration
and Merck initiating the first clinical trial in hypertensive volunteers in
the first half of this year. We believe NicOx is in a strong position to
face the future and we look forward to confirming the efficacy and blood
pressure profile of naproxcinod during the second half of 2008.”
Revenues for the first half of 2008 were EUR 2.2 million, compared to EUR
11.2 million during the same period in 2007. These revenues were due to
payments received from NicOx’ partnered programs with Merck & Co., Inc. in
the antihypertensive field and Pfizer Inc in ophthalmology.
For the first six months of 2008, operating expenses were EUR 40.6 million,
compared to EUR 23.7 million for the same period in 2007. The majority of
these expenses relate to the phase 3 and the overall clinical development
of naproxcinod, NicOx’ lead drug candidate, which is a unique, first in
class, Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) in
development for the treatment of the signs and symptoms of osteoarthritis.
The Company recorded a net loss of EUR 33.1 million for the first six
months of 2008, compared to a net loss of EUR 6.6 million for the same
period in 2007. On June 30, 2008, NicOx had cash, cash equivalents and
current and non-current financial instruments of EUR 141.6 million,
compared to EUR 195.2 million on June 30, 2007.
Review of the first six months of 2008:
Naproxcinod phase 3 studies near completion ahead of projected New Drug
Application (NDA) filing in mid 2009
NicOx’ plan for the regulatory filing of naproxcinod consists of three
pivotal phase 3 trials (the 301, 302 and 303 studies). Each of these
studies has been designed to compare the efficacy of naproxcinod to placebo
on three standard co-primary endpoints after 13 weeks.
Positive efficacy and blood pressure results from the 301 study, which was
conducted in patients with osteoarthritis of the knee, were presented at
the American College of Rheumatology (ACR) in November 2007. An additional
analysis of the Office Blood Pressure Measurements (OBPMs) from the 301
study was presented in June 2008 at the European League Against Rheumatism
(EULAR) and showed a statistically significant difference (p < 0.05, for 3
out of 4 comparisons) between naproxcinod and naproxen in terms of the mean
change from baseline in systolic and diastolic blood pressure at week 13.
Patient enrollment in the 302 study was successfully completed in December
2007 and 26-week efficacy and safety results are expected in the third
quarter of 2008.
NicOx announced in May 2008 the completion of enrollment in the third
pivotal phase 3 naproxcinod trial (the 303 study) in 810 patients with
osteoarthritis of the hip. The objective of this study is to assess
naproxcinod’s efficacy in relieving the signs and symptoms of
osteoarthritis of the hip and provide additional safety data, including
further information on naproxcinod’s blood pressure profile, as assessed by
OBPM, in comparison to naproxen. Results from this study are expected in
the fourth quarter of 2008.
Following the completion of the phase 3 program, NicOx plans to perform a
predefined statistical analysis on the pooled OBPM data from the phase 3
studies, which should be complete in the fourth quarter of 2008.
NicOx signed an agreement with Archimica in March 2008 for the commercial
manufacture and supply of naproxcinod drug substance. The goal of this
agreement is to provide NicOx with the manufacturing scalability required
to support a successful commercial launch of naproxcinod following the
projected filing of an NDA with the FDA in mid-2009.
In July 2008, NicOx completed the enrollment of two large US clinical
studies, which will assess the blood pressure profile of naproxcinod in
comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure
Monitoring (ABPM) technique. The two studies have recruited a total of 417
osteoarthritis patients with controlled hypertension and results are
projected in the fourth quarter of 2008.
Merck & Co., Inc. initiates first clinical study in hypertensive volunteers
In May, NicOx announced the initiation of the first in a series of planned
clinical trials in hypertensive volunteers by Merck & Co., Inc. as part of
the companies’ 2006 collaborative agreement to develop new nitric oxide-
donating antihypertensive agents. Two of the three drug candidates selected
for development from the companies’ joint research program have completed
initial dose ranging studies in healthy volunteers with encouraging
results. The most advanced candidate is being evaluated in a single
ascending dose trial in mild to moderate hypertensive volunteers. A number
of clinical trials in hypertensive volunteers will be conducted by Merck
prior to the selection of the compound or compounds that will ultimately be
advanced into phase 2 testing. Merck will oversee the development of these
compounds moving forward.
PF-03187207 meets secondary endpoints in phase 2 study conducted by Pfizer
Inc; Japanese phase 2 trial fully enrolled
In May, NicOx announced the results of a U.S. phase 2 study conducted by
Pfizer, which compared the safety and efficacy of various doses of the
nitric oxide-donating prostaglandin analog PF-03187207 to Xalatan®
(latanoprost) 0.005% in patients with primary open-angle glaucoma and
ocular hypertension. The highest dose of PF-03187207 showed consistently
more intraocular pressure (IOP) lowering than Xalatan® 0.005%, at all
study visits and at all individual time points. Abnormally raised IOP is
one of the principal symptoms of glaucoma. On the primary endpoint at 28
days, PF-03187207 showed a 12% improvement over Xalatan® 0.005%, which
did not reach statistical significance. PF-03187207 did show significance
over Xalatan® 0.005% on a number of secondary endpoints (p < 0.05).
Following the phase 2 results, Pfizer took the decision not to launch a
global phase 3 development program for PF-03187207. Pfizer is currently
conducting a phase 2 study for PF-03187207 in Japan, which has completed
patient enrollment and NicOx will communicate the top-line results
subsequent to Pfizer’s review of the data and determination of the
potential future development path for PF-03187207 in Asia.
Pfizer has extended its March 2006 ophthalmology agreement with NicOx
In January, NicOx announced it had signed an extension of its March 2006
collaboration agreement, which grants Pfizer Inc the exclusive right to
apply its proprietary nitric oxide-donating technology to drug discovery
research across the entire field of ophthalmology. The agreement provides
for total potential milestone payments in excess of EUR 300 million in the
ophthalmology field and industry standard royalties on sales, of which EUR
102 million would arise from the successful full development and launch of
the first program compound. Pfizer’s option to obtain an exclusive
worldwide license to develop and commercialize compounds covered by this
agreement in the field of ophthalmology currently runs until May 2009.
Review of the consolidated financial results for the six months ended June
30, 2008 and 2007:
Revenues
For the six months ended June 30, 2008, NicOx’ revenues reached EUR 2.2
million, compared to EUR 11.2 million for the six months ended June 30,
2007. This significant decrease is mainly explained by the fact that the
company received EUR 5.0 million from Merck and EUR 1.0 million from Pfizer
in 2007, which was entirely recognized as revenues in the first semester of
2007.
During the first semester of 2008, NicOx only recognized the following
sums, initially recorded as prepaid income, in revenues:
– EUR 0.18 million corresponding to the initial payment of EUR 5.0 million
from Pfizer, as a technology exclusivity fee, following the March 2006
agreement that granted Pfizer rights to an exclusive worldwide license to
develop and commercialize new drug candidates using NicOx’ proprietary
technology in the field of ophthalmology
– EUR 1.5 million corresponding to the funding of the research
collaboration, pursuant to the above referenced agreement signed with
Pfizer in March 2006
– EUR 0.56 million corresponding to the balance of the spreading of the
initial payment of EUR 9.2 million received from Merck following the
signature of a collaboration agreement for new antihypertensive drug
candidates in March 2006
The initial March 2006 payments from Pfizer and Merck, listed above, were
deferred over the estimated duration of NicOx’ involvement in the research
and development programs provided for under the terms of the corresponding
agreements. The terms surrounding the duration of NicOx’ involvement in
these programs are revised periodically, if necessary. The remaining
balance from the initial payment received from Merck was entirely
recognized as revenues in the first semester of 2008. The payments received
from Pfizer for the funding of the research activities are deferred over a
period of 12 months from the date of invoice.
Operating expenses
Operating expenses reached EUR 40.6 million for the six months ended June
30, 2008, compared to EUR 23.7 million for the six months ended June 30,
2007 (adjusted to reflect the reclassification of the research tax credit
subsidies into other income as indicated below). Operating expenses for the
first semester of 2008 were 86% attributable to research and development
expenses and 14 % attributable to selling and administrative expenses,
compared to 74% and 26% respectively during the first semester of 2007.
Research and development expenses amounted to EUR 34.8 million in the six
months ended June 30, 2008, compared to EUR 17.6 million in the six months
ended June 30, 2007 (including EUR 0.5 million allocated to cost of sales
in the first semester of 2008 and EUR 1.1 million in the first semester of
2007). This very significant increase of research and development expenses
is primarily due to the costs associated with the phase 3 development of
naproxcinod, such as expenses related to contract research organizations
and suppliers involved in naproxcinod’s clinical development and
manufacturing activities. At this time, the cost of sales principally
corresponds to the expenses incurred by NicOx in performing research
activities under the contracts signed with Pfizer and Merck. The Company
anticipates that research and development expenses will remain at a high
level during the second semester of 2008, due to the end of phase 3
clinical studies on naproxcinod and the increase of the activities linked
to the production of this compound. On June 30, 2008, the Company employed
94 people in research and development, compared to 77 people on June 30,
2007.
Administrative and selling expenses reached EUR 5.8 million in the six
months ended June 30, 2008, compared to EUR 6.1 million in the six months
ended June 30, 2007. General and administrative expenses were EUR 3.6
million during the first semester of 2008, compared to EUR 4.2 million for
the corresponding period of 2007 and were primarily the result of personnel
expenses in administrative and financial functions, as well as the
remuneration of corporate officers, including stock option, bonus share and
warrant attributions. These expenses also included structural costs such as
leases, property service charges and maintenance costs (excluding
structural costs related to research and development activities), legal and
accounting fees and other external administrative costs. Selling expenses
totaled EUR 2.2 million for the first semester of 2008, compared to EUR 1.9
million for the first semester of 2007, and correspond to the market
analysis activities for naproxcinod, as well as the business development
and communication activities of the Company. The Company anticipates an
increase in its selling expenses during the second semester of 2008, due to
activities linked to the commercial launch preparation for naproxcinod. On
June 30, 2008, the Company employed 35 people in its selling, general, and
administrative departments, compared to 32 people on June 30, 2007.
Other income
During the first semester of 2008, other income amounted to EUR 2.4
million, compared to EUR 2.7 million on June 30, 2007.
Other income corresponds to the operational subsidies from the research tax
credits which were previously deducted from research and development
expenses until December 31, 2007.
Operating result
The operating loss amounted to EUR 36.0 million for the six months ended
June 30, 2008, compared to EUR 9.8 million for the same period of 2007.
This situation results primarily from the strong increase in operating
expenses during the first semester of 2008 and from the considerable
decrease in revenues recognized during the period as indicated above.
Other results
Net financial income totaled EUR 3.0 million for the first six months of
2008, compared to EUR 3.2 million for the corresponding period of 2007.
The income tax expense incurred by NicOx during the first semester of 2008
relates principally to its Italian subsidiary and amounted to EUR 0.1
million, compared to a non significant tax credit during the same period of
2007.
Net result
The net loss reached EUR 33.1 million for the six months ended June 30,
2008, compared to EUR 6.6 million for the six months ended June 30, 2007.
As indicated above, this strong increase in net loss during the first
semester of 2008 results from the significant increase of research and
development expenses associated with naproxcinod and from the considerable
decrease in the revenues recognized during this period.
Balance sheet items
The indebtedness incurred by NicOx is mainly short-term operating debt. On
June 30, 2008, the Company’s current liabilities amounts to EUR 22.0
million, including EUR 16.8 million in accounts payable to suppliers and
external collaborators, EUR 2.5 million in accrued compensation for
employees, EUR 2.2 million in deferred revenues due to payments received
under collaboration agreements, EUR 0.2 million in corporate taxes payable,
EUR 0.2 million for other liabilities and EUR 0.1 million in current income
tax payable.
During the first semester of 2008, Axcan Pharma and NicOx agreed to
terminate their collaboration agreement and Axcan accordingly made a final
balancing payment of EUR 2.2 million under the development cost-sharing
arrangements.
In the first semester of 2008, NicOx granted Archimica a loan totaling EUR
6 million, payable in 9 monthly installments, as part of the financial
terms of the manufacturing and supply agreement with this company. On June
30, 2008, the amount paid by NicOx under this agreement was EUR 4.0
million.
On June 30, 2008, the Company’s current and non-current financial
instruments and cash and cash equivalents amounted to EUR 141.6 million,
compared to EUR 195.2 million on June 30, 2007. The Company uses its liquid
assets principally to cover research and development expenses, expenses
relating to the development of relationships with pharmaceutical companies,
with a view to encouraging new partnerships, and corporate expenses related
to general and administrative and promotional activities. NicOx expects its
operating expenses to continue to increase very strongly over the coming
financial years, as a result of the anticipated expenses related to the
clinical development and the launch preparation activities for its drug
candidate naproxcinod, which is currently in phase 3 clinical development.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development and future
commercialization of investigational drugs for unmet medical needs. NicOx
is applying its proprietary nitric oxide-donating technology to develop an
internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas
of inflammatory and cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary NCE
and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-
Donating (CINOD) class of anti-inflammatory agents, which is in phase 3
clinical studies for the treatment of the signs and symptoms of
osteoarthritis, with final phase 3 results anticipated in 2008.
Beyond naproxcinod, NicOx has a pipeline containing multiple nitric oxide-
donating NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalent
and underserved diseases, such as atherosclerosis, hypertension, glaucoma
and Chronic Obstructive Pulmonary Disease (COPD).
NicOx S.A. is headquartered in France and is listed on the Euronext Paris
Stock Exchange (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
CONTACTS: http://www.nicox.com NicOx: Karl Hanks - Director of Investor Relations and Corporate Communication - Tel +33 (0)4 97 24 53 42 - [email protected] Media in the United States - FD: Robert Stanislaro - Tel +1 212 850 5657 - [email protected] Irma Gomez-Dib - Tel +1 212 850 55761 - [email protected] Media in Europe - Citigate Dewe Rogerson: David Dible - Tel +44 (0)207 282 2949 - [email protected] Sylvie Berrebi - Tel +44 (0)207 282 1050 - [email protected]
CONSOLIDATED INCOME STATEMENT
+-------------------------+-+--------------------+-+-------------+ | | |Period of 6 months | | | | | |ended on | | | +-------------------------+-+--------------------+-+-------------+ | | |30 June 2008 | |30 June 2007 | +-------------------------+-+--------------------+-+-------------+ | | |(in thousands of EUR | | | | | |except for per share| | | | | |data) | | | +-------------------------+-+--------------------+-+-------------+ |Revenues | |2,243 | | 11,176 | +-------------------------+-+--------------------+-+-------------+ |Cost of goods and | |(537) | | (1,115) | |services sold | | | | | +-------------------------+-+--------------------+-+-------------+ |Research and development | |(34,298) | | (16,487) | |expenses | | | | | +-------------------------+-+--------------------+-+-------------+ |Administrative and | |(5,780) | | (6,072) | |selling expenses | | | | | +-------------------------+-+--------------------+-+-------------+ |Other products | |2,376 | | 2,690 | +-------------------------+-+--------------------+-+-------------+ |Operating loss | |(35,996) | | (9,808) | +-------------------------+-+--------------------+-+-------------+ |Net financial income | |3,025 | | 3,163 | +-------------------------+-+--------------------+-+-------------+ |Loss before income tax | |(32,971) | | (6,645) | +-------------------------+-+--------------------+-+-------------+ |Income tax expense | |(129) | | 3 | +-------------------------+-+--------------------+-+-------------+ |Loss for the period | |(33,100) | | (6,642) | +-------------------------+-+--------------------+-+-------------+ |Attributable to: | | | | | +-------------------------+-+--------------------+-+-------------+ |- Equity holders of the | |(33,100) | | (6,642) | |Company | | | | | +-------------------------+-+--------------------+-+-------------+ |- minority interests | |- | | - | +-------------------------+-+--------------------+-+-------------+ |Earnings per share for | |(0.70) | | (0.15) | |profit attributable to | | | | | |equity holders of the | | | | | |Company | | | | | +-------------------------+-+--------------------+-+-------------+ |Diluted | |(0.70) | | (0.15) | +-------------------------+-+--------------------+-+-------------+
CONSOLIDATED BALANCE SHEET
+-------------------------+--------------------+-+-----------------+ | | 30 June 2008 | |31 December 2007 | +-------------------------+--------------------+-+-----------------+ | |(in thousands of EUR ) | | | +-------------------------+--------------------+-+-----------------+ |ASSETS | | | | +-------------------------+--------------------+-+-----------------+ |Non current assets | | | | +-------------------------+--------------------+-+-----------------+ |Property, plant, & | 3,467 | | 2,720 | |equipment | | | | +-------------------------+--------------------+-+-----------------+ |Intangible assets | 621 | | 464 | +-------------------------+--------------------+-+-----------------+ |Non-current financial | 4,639 | | 14,402 | |instruments | | | | +-------------------------+--------------------+-+-----------------+ |Government subsidies | 7,602 | | 5,264 | |receivable | | | | +-------------------------+--------------------+-+-----------------+ |Other financial assets | 4,247 | | 186 | +-------------------------+--------------------+-+-----------------+ |Deferred income tax | 10 | | 10 | |assets | | | | +-------------------------+--------------------+-+-----------------+ |Total non-current assets | 20,586 | | 23,046 | +-------------------------+--------------------+-+-----------------+ |Current assets | | | | +-------------------------+--------------------+-+-----------------+ |Trade receivables | 1 | | 2,224 | +-------------------------+--------------------+-+-----------------+ |Government subsidies | 133 | | 133 | |receivable | | | | +-------------------------+--------------------+-+-----------------+ |Other current assets | 1,619 | | 2,564 | +-------------------------+--------------------+-+-----------------+ |Prepaid expenses | 3,884 | | 3,083 | +-------------------------+--------------------+-+-----------------+ |Current financial | 14,629 | | 14,967 | |instruments | | | | +-------------------------+--------------------+-+-----------------+ |Cash and cash equivalents| 122,369 | | 143,444 | +-------------------------+--------------------+-+-----------------+ |Total current assets | 142,635 | | 166,415 | +-------------------------+--------------------+-+-----------------+ |TOTAL ASSETS | 163,221 | | 189,461 | +-------------------------+--------------------+-+-----------------+ |EQUITY AND LIABILITIES | | | | +-------------------------+--------------------+-+-----------------+ |Capital and Reserves | | | | |attributable to equity | | | | |holders of the Company | | | | +-------------------------+--------------------+-+-----------------+ |Share Capital | 9,487 | | 9,457 | +-------------------------+--------------------+-+-----------------+ |Other reserves | 130,505 | | 159,757 | +-------------------------+--------------------+-+-----------------+ |Minority interests | - | | - | +-------------------------+--------------------+-+-----------------+ |Total Equity | 139,992 | | 169,214 | +-------------------------+--------------------+-+-----------------+ |Non-current liabilities | | | | +-------------------------+--------------------+-+-----------------+ |Provisions for other | 1,069 | | 201 | |liabilities and charges | | | | +-------------------------+--------------------+-+-----------------+ |Deferred income tax | 120 | | 120 | |liabilities | | | | +-------------------------+--------------------+-+-----------------+ |Finance lease | 16 | | 19 | +-------------------------+--------------------+-+-----------------+ |Other loans and | 1 | | - | |non-current liabilities | | | | +-------------------------+--------------------+-+-----------------+ |Total non-current | 1,206 | | 340 | |liabilities | | | | +-------------------------+--------------------+-+-----------------+ |Current liabilities | | | | +-------------------------+--------------------+-+-----------------+ |Provisions for other | - | | - | |liabilities and charges | | | | +-------------------------+--------------------+-+-----------------+ |Finance lease | 6 | | 10 | +-------------------------+--------------------+-+-----------------+ |Trade payables | 16,754 | | 13,858 | +-------------------------+--------------------+-+-----------------+ |Deferred revenue | 2,238 | | 1,481 | +-------------------------+--------------------+-+-----------------+ |Current income tax | 102 | | 51 | |liabilities | | | | +-------------------------+--------------------+-+-----------------+ |Social security and other| 2,724 | | 4,197 | |taxes | | | | +-------------------------+--------------------+-+-----------------+ |Other liabilities | 199 | | 310 | +-------------------------+--------------------+-+-----------------+ |Total current liabilities| 22,023 | | 19,907 | +-------------------------+--------------------+-+-----------------+ |TOTAL EQUITY AND | 163,221 | | 189,461 | |LIABILITIES | | | | +-------------------------+--------------------+-+-----------------+
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
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