SOPHIA ANTIPOLIS, France, March 3 /PRNewswire-FirstCall/ -- NicOx S.A. 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).
American College
“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, Chairman 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:
American College
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
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.
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:
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:
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.
Operating expenses
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, 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.
Operating loss
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.
Other results
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.
Net loss
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 (http://www.nicox.com).
CONTACT: Karl Hanks, Director of Investor Relations and Corporate
Communications, NicOx S.A., +33-4-97-24-53-42, hanks@nicox.com; Investors
in the United States, Lisa Burns, lburns@burnsmc.com, Juliane Snowden,
jsnowden@burnsmc.com, +1-212-213-0006, both of Burns McClellan; Media in
the United States, Jonathan Birt of FD, +1-212-850-5634, jbirt@fd-us.com;
Media in Europe, David Dible, +44-207-282-2949,
david.dible@citigatedr.co.uk, Sylvie Berrebi, +44-77-67-77-15-33,
sylvie.berrebi@cititgatedr.co.uk, both of Citigate Dewe Rogerson
Web site: http://www.nicox.com/
