SOPHIA ANTIPOLIS, France, March 3 /PRNewswire-FirstCall/ -- NicOx S.A.
(Euronext Paris: COX) today announced its financial results for 2007 and
provided an overview of its activities during the year. NicOx also
announced today the initiation of two large Ambulatory Blood Pressure
Monitoring (ABPM) studies for naproxcinod (see separate press release).
Key highlights 2007:
-- Initiation of the two remaining pivotal phase 3 trials for naproxcinod
(the 302 and 303 studies) and completion of enrollment in the 302 study
-- Presentation of the naproxcinod phase 3 results at the American College
of Rheumatology (the 301 study) and data from an Ambulatory Blood
Pressure Monitoring trial at the American Heart Association (the 104
-- Initiation of a phase 2 proof-of-concept study designed to compare the
safety and efficacy of PF-03187207 to Pfizer Inc's Xalatan
-- Start of clinical development for the first nitric oxide-donating
antihypertensive by Merck & Co., Inc.
-- Initiation of a phase 2 proof-of-concept study for TPI 1020 in Chronic
Obstructive Pulmonary Disease (COPD), following promising top-line
results in a phase 2a study in asthmatic smokers
-- Establishment of NicOx' United States (U.S.) headquarters in Warren,
New Jersey, as a base for Commercial Affairs and Clinical Operations in
-- Strengthening of the Company's executive management team, through the
appointment of Pascal Pfister, MD as Chief Scientific Officer (CSO),
and Sanjiv Sharma as Vice President Commercial Affairs
"We envision that 2008 will be a transformational year for NicOx. We expect to complete the pivotal phase 3 program for naproxcinod, including a pooled analysis of the Office Blood Pressure Measurements, ahead of a projected New Drug Application filing in mid-2009," said Michele Garufi, Chair, compared to 64 people on December 31, 2006.
Administrative and selling expenses amounted to euro 11.3 million in 2007, compared to euro 7.7 million in 2006. General and administrative expenses were euro 3.2 million in 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, gratuitous 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, which reached euro 8.1 million in 2007, were the result of market analysis activities for naproxcinod, as well as business development and communication activities. The increase in selling expenses is also due to the hiring of new personnel following the creation, in 2007, of a commercial department whose primary function is to develop commercial strategies for NicOx' product portfolio. On December 31, 2007, the Company employed 33 people in selling, general, and administrative departments, compared to 25 people on December 31, 2006.
The operating loss amounted to euro 37.2 million in 2007, compared to euro 26.7 million in 2006. This increase results primarily from the strong increase in operating expenses as indicated above.
Net financial income amounted to euro 5.2 million in 2007, compared to euro 2.2 million in 2006. Net financial income has benefited from the increase in the Company's cash, cash equivalents, and financial instruments following the capital increase completed in February 2007.
The income tax expense incurred by NicOx in 2007 relates principally to its Italian subsidiary and amounts to euro 0.1 million compared to euro 0.3 million in 2006.
The net loss increased by euro 7.4 million in 2007 to reach euro 32.1 million, compared to euro 24.7 million in 2006. This increase in the consolidated net loss remains limited, as the strong increase in operational expenses has been offset to a large extent by the significant increase in revenues recognized over the financial year, the significant increase in the research tax credit and its impact on the research and development expenses and the increase in the net financial income following the investment of the net proceeds of the rights offering completed in February 2007.
Balance sheet items and net burn rate
The indebtedness incurred by NicOx is mainly short-term operating debt. On December 31, 2007, the Company's current liabilities amounted to euro 19.9 million, including euro 13.9 million in accounts payable to suppliers and external collaborators, euro 2.5 million in taxes payable, euro 1.6 million in accrued compensation for employees euro 1.5 million in deferred revenues due to payments received under collaboration agreements, euro 0.3 million for other liabilities and euro 0.1 million in corporate taxes payable.
NicOx had no outstanding loans on December 31, 2007.
On December 31, 2007, the Company's current and non-current financial instruments and cash and cash equivalents amounted to euro 172.8 million, compared to euro 81.7 million on December 31, 2006. This significant increase in financial instruments, cash and cash equivalents is primarily attributed to the capital increase with preferential rights completed in February 2007, the net proceeds of which amounted to euro 120.7 million. 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.
The net burn rate, defined with reference to the cash flow statement, represents the net cash the Company spent in conducting its operational activities, excluding net proceeds resulting from its investment and financing activities. The Company's net burn rate in 2007 amounted to euro 29.5 million, compared to euro 17.8 million in 2006. This significant increase in the net burn rate, notwithstanding the increase in payments relating to collaboration and development agreements received by the Company, for an aggregate amount of euro 14.0 million in 2007, is explained by the significant increase in the operational expenses incurred by the Company in 2007. NicOx expects its burn rate to continue to further 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, 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 COX-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
CONSOLIDATED STATEMENT OF OPERATIONS
Fiscal year ended December 31
(euro thousands except for per share data)
Revenues 20,620 9,630
Cost of sales (2,151) (1,605)
Research and development expenses (44,345) (26,966)
Administrative and selling expenses (11,322) (7,717)
Operating loss (37,198) (26,658)
Net financial income 5,183 2,223
Loss before income tax (32,015) (24,435)
Income tax expense (129) (261)
Loss for the year (32,144) (24,696)
- Equity holders of the Company (32,144) (24,696)
- Minority interests - -
Earnings per share for profit
attributable to the equity holders
of the Company during the year (0,69) (0,69)
Diluted earning per share (0,69) (0,69)
CONSOLIDATED BALANCE SHEET
Fiscal year ended December 31
Property, plant & equipment 2,720 1,900
Intangible assets 464 214
Non-current financial instruments 14,402 -
Government subsidies receivable 5,264 1,521
Other financial assets 186 141
Deferred income tax assets 10 11
Total non-current assets 23,046 3,787
Trade receivables 2,224 2,142
Government subsidies receivables 133 708
Other current assets 2,564 1,670
Prepaid expenses 3,083 1,362
Current financial instruments 14,967 27,602
Cash and cash equivalents 143,444 54,138
Total current assets 166,415 87,622
TOTAL ASSETS 189,461 91,409
Capital and Reserves attributable to
equity holders of the Company
Ordinary shares 9,457 7,610
Other reserves 159,757 66,302
Minority interests in equity - -
Total Equity 169,214 73,912
Provisions for other liabilities
and charges 201 118
Deferred income tax liabilities 120 110
Finance lease 19 34
Total non-current liabilities 340 262
Provisions for other liabilities
and charges - 17
Finance lease 10 17
Trade payables 13,858 6,188
Deferred revenue 1,481 8,102
Current Income tax payable 51 209
Social security and other taxes 4,197 2,702
Other liabilities 310 -
Total current liabilities 19,907 17,235
TOTAL LIABILITIES & SHAREHOLDERS'
EQUITY 189,461 91,409man and CEO of NicOx. "In our view, naproxcinod is very well positioned in the face of increasing regulatory demands and its commercial potential has increased substantially during 2007, due to set backs suffered by possible competitors."
Financial summary of 2007
NicOx achieved a significant increase in revenues during 2007 reaching euro 20.6 million, compared to euro 9.6 million in 2006. This increase is primarily due to payments from Merck & Co., Inc. and Pfizer Inc. Operating expenses totaled euro 57.8 million in 2007, compared to euro 36.3 million in 2006. The majority of these expenses are associated with the phase 3 development of naproxcinod. Naproxcinod is NicOx' lead drug candidate, a unique, first in class, COX-Inhibiting Nitric Oxide Donator (CINOD), for the treatment of the signs and symptoms of osteoarthritis. In 2007, NicOx' net loss increased by euro 7.4 million to reach euro 32.1 million, compared to euro 24.7 million in 2006.
On December 31, 2007, the Company had cash, cash equivalents and financial instruments of euro 172.8 million, compared to euro 81.7 million on December 31, 2006. This significant increase is primarily due to the capital increase that was completed in February 2007, with net proceeds of euro 120.7 million.
"We have seen a controlled increase in operating expenses during 2007 and have budgeted for a further increase during 2008, which is primarily due to the clinical development and launch preparation costs for naproxcinod," said Eric Castaldi, Chief Financial Officer of NicOx. "Nevertheless, our strong balance sheet should allow us to leverage the unique potential of naproxcinod, while exploring other late stage product opportunities which could mitigate the risk associated with our planned transition into an integrated pharmaceutical company. We are firmly convinced that NicOx enters 2008 in the strongest position it has ever held and we look to the future with great optimism."
Considerable progress in the pivotal phase 3 program for naproxcinod
NicOx is developing naproxcinod in phase 3 clinical studies, which are designed to demonstrate that it is safe, well tolerated and effective for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to existing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
The phase 3 efficacy program consists of 3 pivotal studies, which are
being conducted for regulatory submissions in the U.S. and Europe:
-- The 301 study was conducted in patients with osteoarthritis of the knee
and has provided successful efficacy and blood pressure results which
were presented at the American College of Rheumatology (ACR) in
November 2007. A 52-week open-label safety extension of this study has
now been completed and data are currently being analyzed
-- The 302 study started enrolling patients with osteoarthritis of the
knee in the U.S. in April 2007 and the enrollment of 1020 patients was
successfully completed in December 2007. 26-week efficacy and safety
results are anticipated in the third quarter of 2008
-- The 303 study was initiated in June 2007 in the U.S. and Europe, in
patients with osteoarthritis of the hip. This study is expected to
complete enrollment in the second quarter of 2008 and 13-week efficacy
and safety results are anticipated in 4Q'08
As in the 301 study, patients in the ongoing 302 and 303 studies are undergoing controlled, standardized Office Blood Pressure Measurements (OBPM) at each visit to the treatment center. 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 projects the submission of a New Drug Application (NDA) for naproxcinod to the U.S. Food and Drug Administration (FDA) in mid-2009.
NicOx has previously completed a clinical study for naproxcinod, which used the 24-hour ABPM monitoring technique to assess the blood pressure profile of naproxcinod in healthy volunteers with stable hypertension (the 104 study) and results of this trial were presented at the American Heart Association (AHA) in November 2007. Today, NicOx announced the initiation of two further studies using the ABPM technique in osteoarthritis patients (see separate press release).
Damian Marron, Executive Vice President of Corporate Development at NicOx, declared: "Beyond naproxcinod, our nitric oxide-donating technology has delivered a broad pipeline of drug candidates in phase 1 and 2, which have highly differentiated profiles and are rapidly advancing through the clinic. These compounds are being developed for serious and prevalent diseases, such as hypertension, glaucoma and COPD, where there is a clear need for improved drugs. According to our forecasts, they have the potential to generate considerable revenues in the mid-to-long term."
Phase 2 proof-of-concept study for PF-03187207 in glaucoma
In March 2007, Pfizer Inc initiated the first phase 2 proof-of-concept clinical study for PF-03187207 in the U.S. and top-line results are expected during April 2008, following the completion of the data analysis. The objective of this study is to compare the safety and efficacy of PF-03187207 to Xalatan (latanoprost). Xalatan is a proprietary Pfizer product and the leader in worldwide glaucoma sales, with approximately $1.6 billion of franchise sales in 2007. A second phase 2 proof-of-concept study was initiated in Japan in January 2008. In February 2007, NicOx and Pfizer presented promising preclinical results from a prototype compound, which is a nitric oxide-donating prostaglandin F2-alpha analog, at the Association for Ocular Pharmacology and Therapeutics 8th Scientific Meeting.
NicOx and Pfizer have also made good progress in the major collaborative agreement signed in March 2006, which granted Pfizer exclusive rights to apply NicOx' nitric oxide-donating technology across the entire field of ophthalmology. This collaboration involves several separate projects focused on major ocular diseases and encouraging results have been observed in the most advanced program. During 2007, NicOx received euro 3.0 million from Pfizer in research funding for the second year of this collaboration and Pfizer has subsequently signed a one-year extension of the research phase of this agreement, which will result in NicOx receiving a further euro 3 million in research funding in March 2008.
Clinical program initiated for new nitric oxide-donating anti-hypertensive agents
In July 2007, the program to develop new nitric oxide-donating antihypertensive agents entered clinical development, with the initiation of the first in a series of planned studies for the first selected drug candidate. These clinical studies are covered by a major agreement between NicOx and Merck & Co., Inc., which covers nitric oxide-donating derivatives of several major classes of antihypertensive agents. Merck and NicOx selected the first candidate in January 2007 and IND-enabling toxicology studies were subsequently initiated and an IND was filed in May. The achievement of these milestones resulted in NicOx receiving euro 10.0 million in payments from Merck during 2007.
TPI 1020 advanced into a phase 2 proof-of-concept study by Topigen
In November 2007, TOPIGEN Pharmaceuticals Inc. dosed the first patients in a phase 2 proof-of-concept study for TPI 1020 (formerly NCX 1020) in Chronic Obstructive Pulmonary Disease (COPD). This study is expected to provide the first assessment of TPI 1020's potential activity in COPD. TPI 1020 is a novel respiratory anti-inflammatory, which was licensed by Topigen from NicOx.
In September 2007, TPI 1020 delivered promising top-line results from a phase 2a study in asthmatic smokers. These results showed a good safety and tolerability profile for TPI 1020, in addition to certain anti-inflammatory effects which could be potentially beneficial in COPD. Topigen is responsible for all further development costs for this program and has rights to TPI 1020 for North America and an option to obtain rest of world rights.
NCX 4016 is a nitric oxide-donating derivative of acetyl-salicylic acid, which has generated encouraging preliminary results in type 2 diabetes patients in three clinical studies. The planned program for NCX 4016 in type 2 diabetes was put on hold in 2007, due to unexpected in vitro test results observed for NCX 4015, a potential, specific metabolite of NCX 4016. NicOx has not received any further results suggesting a potential concern with NCX 4015.
Following an in-depth internal evaluation of the projected NCX 4016
development timeline and costs, the Company has decided to discontinue NCX
4016 and focus its resources on the development of naproxcinod and other
compounds in its pipeline.
Other important achievements and updates
-- In February 2007, NicOx successfully completed a capital increase with
preferential subscription rights for existing shareholders, which
raised net proceeds of euro 120.7 million. There was demand for new
ordinary shares totaling euro 227 million, with the offering therefore
being covered 1.75 times
-- In November 2007, Orexo AB acquired the rights to NCX 1510 through its
merger with Biolipox AB (see Orexo Press Release of November 23, 2007).
NCX 1510 is a nitric oxide-donating drug candidate for the treatment of
allergic rhinitis. A nasal spray formulation of this compound using
Orexo's NLA technology has completed phase 2a clinical development and
Orexo is seeking possible partnerships to further advance the
development of its NLA program, which includes candidates other than
NicOx' NCX 1510. A potential partnership and further development of the
NLA program may include NCX 1510 or could exclude NCX 1510 and instead
focus on other formulations of Orexo's NLA technology
-- In October 2007, NicOx and Ferrer Grupo International jointly presented
clinical and preclinical results from their collaboration at the 21st
World Congress of Dermatology
-- In July 2007, NicOx appointed Pascal Pfister MD as Chief Scientific
Officer (CSO). Dr. Pfister reports to Michele Garufi, Chairman and CEO,
and has overall responsibility for NicOx' Research and Development
(R&D) activities. Dr. Pfister brings extensive experience and
leadership to NicOx from his 19 year career at Novartis and Sandoz
-- In October 2007, NicOx opened its U.S. headquarters in Warren, New
Jersey, where the Company has based its newly established Commercial
Affairs and North American Clinical Operations departments. This
followed the appointment of Sanjiv Sharma as Vice President of
Commercial Affairs in April 2007, who is also head of the U.S. Office.
Sanjiv brings extensive marketing and sales management experience to
NicOx, from his previous positions at Biovail Pharmaceutical Inc. and
Sanofi-Aventis and its predecessor companies
Review of the financial results on December 31, 2007 and 2006:
In 2007, NicOx' revenues increased by euro 11.0 million to reach euro
20.6 million, compared to euro 9.6 million in 2006. This significant
increase results from the following payments that were entirely recognized
as revenues in 2007:
-- Euro 5.0 million received from Merck in January 2007, following the
initiation of toxicology studies on the first development candidate
which had been recently selected, in the context of the agreement
signed with Merck in March 2006
-- Euro 1.0 million received from Pfizer in April 2007, following the
review of an Investigational New Drug (IND) submission by the U.S. FDA
for a new experimental medicine for the treatment of glaucoma,
developed under the collaboration agreement signed between Pfizer and
NicOx in August 2004
-- Euro 5.0 million received from Merck in July 2007, following the
initiation of the first in a series of planned clinical studies for the
first selected drug candidate, in accordance with the companies' major
collaborative agreement to develop new nitric oxide-donating
antihypertensive agents using NicOx' proprietary technology
These amounts, received by the Company, result from a firm commitment by the other contracting party and have been immediately recognized in revenues because NicOx will not have continuing involvement in the future development of the compounds that are the subject of the collaboration agreements mentioned above.
During the financial year 2007, NicOx also recognized the following
sums, initially recorded as prepaid income, in revenues:
-- Euro 2.5 million corresponding to the initial payment of euro 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
-- Euro 3.0 million corresponding to the funding of the research
collaboration, pursuant to the above referenced agreement signed with
Pfizer in March 2006.
-- Euro 3.8 million corresponding to the initial payment of euro 9.2
million received from Merck following the signature in March 2006 of a
collaboration agreement for new antihypertensive drug candidates
-- Euro 0.3 million corresponding to the allocation of the remaining
balance of the US$2 million license and option payments received from
Axcan following the termination of the development of NCX 1000 in May
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' involvements in these programs are revised periodically, if necessary. 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.
Consolidated operating expenses totaled euro 57.8 million in 2007, compared to euro 36.3 million in 2006, of which, 80.4% were attributable to research and development expenses and 19.6% to selling and administrative expenses during 2007, compared to 78.7% and 21.3%, respectively in 2006.
Research and development expenses reached euro 46.5 million in 2007,
compared to euro 28.6 million in 2006 (including euro 2.2 million allocated
to cost of sales in 2007 and euro 1.6 million in 2006). These expenses are
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. Operational
subsidies from the research tax credit, which are deducted from research
and development expenses, amounted to euro 3.9 million in 2007 compared to
euro 1.2 million in 2006. On December 31, 2007, the Company employed 84
people in research and development
|SOURCE NicOx S.A.|
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