SOPHIA ANTIPOLIS, France, March 1 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: COX) today reported financial results for the twelve months ended December 31, 2006. The Company had cash, cash equivalents and current financial instruments of euro 81.7 million, compared to euro 42.6 million on December 31, 2005. This was primarily due to payments received under the major new agreements signed with Pfizer Inc and Merck & Co., Inc. and a euro 45.5 million private placement financing.
Revenues increased 47.5% to euro 9.6 million in 2006, from euro 6.5 million in 2005, driven primarily by the recognition of payments from Pfizer and Merck. Operational expenses increased by euro 13.4 million to euro 36.3 million in 2006, from euro 22.9 million in 2005, principally due to the costs associated with the successful conduct and completion of the first phase 3 trial for naproxcinod in osteoarthritis of the knee (the 301 study), which met all three of its co-primary efficacy endpoints. 2006 net loss increased by only euro 9.2 million to euro 24.7 million in 2006, from euro 15.5 million in 2005.
* Key highlights 2006 -- Positive results from the first pivotal phase 3 trial for naproxcinod in osteoarthritis (301 study). The trial met all three of its co-primary efficacy endpoints and showed no detrimental effects on blood pressure, with the systolic blood pressure reduction versus naproxen reaching nearly 3 mm Hg at 13-weeks. -- Confirmation of naproxcinod's differentiated blood pressure profile using 24-hour Ambulatory Blood Pressure Monitoring (ABPM). Demonstration of a 2 mm Hg advantage for naproxcinod over naproxen, in terms of systolic and diastolic blood pressure at 2 weeks. -- Establishment of a clear pathway to regulatory submission for naproxcinod in the U.S. and Europe, following the confirmation that a long-term cardiovascular outcomes trial will not be required. -- Decision to advance NCX 4016 into phase 2 trials as an insulin sensitizing agent for the treatment of type 2 diabetes. -- Signature of important licensing agreements with Pfizer and Merck in the major therapeutic areas of ophthalmology and hypertension. -- Five fold increase in NicOx' share price.
Michele Garufi, Chairman and CEO of NicOx, declared: "2006 has witnessed significant progress in the development of NicOx' lead compounds and a considerable strengthening of our financial position. We were successful in confirming the primary differentiating factor for naproxcinod, our lead compound in osteoarthritis, in terms of showing no detrimental effect on blood pressure, and successfully agreed a clear route to market with regulatory authorities in the U.S. and Europe. The signature of major agreements with Pfizer and Merck and the advancement of our research projects lend considerable validation to our proprietary technology. NicOx' strengthened balance sheet and strategic position should allow us to fully exploit the potential of naproxcinod and our wider portfolio, in addition to supporting our planned transition from an R&D to an integrated biopharmaceutical company."
* Strong progress with internal drug development pipeline
Naproxcinod: demonstration of efficacy and an improved blood pressure profile
In October, NicOx announced positive top-line results from the first pivotal phase 3 trial for naproxcinod in patients with osteoarthritis of the knee (the 301 study). Naproxcinod is the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class, which NicOx aims to establish as the drug-of-choice for the treatment of the signs and symptoms of osteoarthritis. The two doses of naproxcinod (750 mg bid and 375 mg bid) were shown to be superior to placebo on all three co-primary efficacy endpoints of the trial at 13 weeks. Additionally, naproxcinod showed a very good safety profile, with the 375 mg bid dose having an adverse event rate that was similar to placebo.
Furthermore, patients' blood pressure was measured by Office Blood Pressure Measurement (OBPM) at each visit to the treatment center and the data demonstrated that both doses of naproxcinod had no detrimental effects on blood pressure and decreased systolic and diastolic blood pressure, versus baseline and compared to naproxen. Naproxen is a non-steroidal anti-inflammatory drug (NSAID) which is commonly prescribed for osteoarthritis.
-- Naproxcinod's beneficial blood pressure profile was sustained until the 13-week time point, when the results showed a difference in systolic blood pressure from baseline, corrected for placebo, of approximately - 0.5 mm Hg for naproxcinod 375 mg bid, -1 mm Hg for naproxcinod 750 mg bid and +2 mm Hg for naproxen. -- In terms of diastolic blood pressure, the differences from baseline, corrected for placebo, were approximately -1 mm Hg for naproxcinod 375 mg bid, -1.5 mm Hg for naproxcinod 750 mg bid and +0.5 mm Hg for naproxen.
NicOx plans to initiate two further pivotal phase 3 trials for naproxcinod in the first half of 2007 (studies 302 and 303), with results expected in 2008.
The improved blood pressure profile of naproxcinod, compared to naproxen, was also confirmed by the results of a pharmacodynamic clinical study in hypertensive subjects, which used Ambulatory Blood Pressure Monitoring (ABPM) to record blood pressure over 24-hours. These results showed a 2 mm Hg difference in both the average systolic and diastolic blood pressure in favor of naproxcinod, in terms of the mean change from baseline as measured by ABPM.
During 2006, NicOx also received positive feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) on the naproxcinod safety database required for the submission of a New Drug Application (NDA) in the US and a Marketing Authorization Application (MAA) in Europe. NicOx will not be required to conduct a long-term cardiovascular outcomes study for naproxcinod and the first regulatory submission is expected to take place in the first quarter of 2009.
Maarten Beekman, Vice-President of Clinical Development at NicOx, declared: "NicOx has been successful in advancing naproxcinod and its broader pipeline in 2006. The first phase 3 results for naproxcinod confirmed the compound's efficacy and showed a differentiated and improved blood pressure profile. This is important, due to the fact that all existing anti- inflammatory agents are known to raise blood pressure to an extent that may increase cardiovascular mortality and because of the frequent association of hypertension and osteoarthritis. Our progress in the cardiometabolic field has also been impressive, with the decision to advance NCX 4016 in type 2 diabetes and the selection of NCX 6560, an NO-donating statin, as a new development candidate."
NCX 4016: decision to advance into phase 2 for type 2 diabetes
In July, NicOx announced its decision to advance NCX 4016, a nitric oxide-donating derivative of acetyl-salicylic acid (aspirin), as a novel insulin sensitizing agent for the treatment of type 2 diabetes. The decision to initiate this clinical program follows encouraging results obtained in type 2 diabetes patients in three previously announced trials for NCX 4016 in the cardiometabolic setting, including data showing an improved glucose utilization and increased insulin sensitivity. NicOx expects to initiate two phase 2 studies in the first half of 2007.
NCX 6560: a next generation statin selected for development
In September 2006, NicOx announced its decision to advance NCX 6560 into preclinical development as a new compound with the potential for broadened and increased benefit in cardiovascular disease. This decision followed very promising results for NCX 6560 in validated cardiovascular disease models.
* Signature of two major partnership agreements
Major new research alliance with Pfizer Inc in ophthalmology
In March, NicOx signed a major new agreement which granted Pfizer Inc exclusive rights to use its proprietary nitric oxide-donating technology across the entire field of ophthalmology. Pfizer made payments of euro 23 million in 2006, of which euro 15 million was as an equity investment, and NicOx stands to receive total potential milestones in the ophthalmology field in excess of euro 300 million, plus royalties. This major new agreement followed the promising results that were obtained in the Companies' August 2004 agreement, which is focused on the research and development of nitric oxide-donating derivatives of prostaglandin F2-alpha analogs for the treatment of glaucoma.
Major agreement with Merck & Co., Inc. in the antihypertensive field
In March, NicOx signed a major agreement with Merck & Co., Inc. to develop new antihypertensive agents using NicOx' proprietary nitric oxide-donating technology for which NicOx received an upfront payment of euro 9.2 million and NicOx recently received a euro 5 million milestone payment for the initiation of pre-IND GLP toxicology studies on the first development candidate. NicOx is eligible for potential further milestone payments of euro 274 million. Moreover, NicOx has the option to co-promote products resulting from the agreement, on a fee-for-detail basis, to specialist physicians in the U.S. and certain major European countries. In November, the two companies jointly presented promising preclinical results for NCX 899, a prototype compound which is a nitric oxide-donating derivative of enalapril, at the American Heart Association Scientific Sessions 2006.
Continued progress with other collaborations
NicOx also saw advances in its collaborations with other partners in 2006, including the initiation of a phase 2 program for TPI-1020 in respiratory disorders with Topigen Inc., the initiation of a phase 2 study for NCX 1000 in portal hypertension with Axcan Pharma and the selection of a development candidate in the dermatology collaboration with Grupo Ferrer.
Successful fund raising of euro 45.5 million by private placement
NicOx successfully completed a private placement in April 2006, reserved for companies and investment funds with experience of investing in the pharmaceutical and biotechnology sectors. Both United States and European investors participated in the financing, which resulted in gross proceeds of euro 45.5 million.
* Financial results 2006
Eric Castaldi, Chief Financial Officer of NicOx, declared: "NicOx almost doubled its financial position during 2006, thanks to the major new agreements signed with Pfizer and Merck and the completion of a private placement financing. We were also successful in controlling costs, with the increase in operating expenses being relatively modest, considering the large phase 3 trial we completed for naproxcinod in the United States."
Revenues
The Company's revenues reached euro 9.6 million in 2006, compared to euro 6.5 million in 2005. This significant increase in revenues came from the following amounts that were recognized as revenues on December 31, 2006:
-- euro 4.6 million corresponding to the initial payment of euro 8 million from Pfizer (euro 5 million as a technology exclusivity fee and euro 3 million in research funding) following the signature in March 2006 of an 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 4.7 million corresponding to the initial payment of euro 9.2 million received from Merck & Co., Inc. following the signature of a collaboration agreement for new antihypertensive drug candidates in March 2006. -- euro 0.3 million corresponding to the allocation during 2006 of the US$ 2 million license and option payments received from Axcan partially in December 2002 and the balance in January 2003.
These sums, initially recorded as prepaid income, have been deferred from February 2003 for Axcan and March 2006 for Pfizer and Merck & Co. Inc., over the estimated duration of the Company's involvement in the development and research programs provided for under the corresponding agreement, the duration of which are revised periodically, if necessary.
Operating expenses
Consolidated operating expenses reached euro 36.3 million in 2006, compared to euro 22.9 million in 2005. This increase of euro 13.4 million results primarily from higher research and development expenses.
Research and development expenses amounted to euro 28.6 million in 2006, compared to euro 18.0 million in 2005 (including euro 1.6 million allocated to the cost of sales in 2006 and euro 1.8 million in 2005). This significant increase is due essentially to development expenses and is primarily explained by the costs of the phase 3 development of naproxcinod, such as expenses relating to external collaborations with clinical research organizations and suppliers involved in the clinical development and the manufacturing activities regarding this compound. On December 31, 2006, the Company employed 64 people in research and development, compared to 52 people on December 31, 2005.
Administrative and selling expenses amounted to euro 7.7 million in 2006, compared to euro 4.9 million in 2005. General and administrative expenses mainly related to personnel expenses in administrative and financial functions and to the remuneration of corporate officers. These expenses also include structural costs (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 correspond to business development and communication activities.
Operating loss
The operating loss amounted to euro 26.7 million on December 31, 2006 compared to euro 16.3 million on December 31, 2005. This significant increase is explained by the strong progression in operating expenses as indicated above.
Other results
Net financial income amounted to euro 2.2 million as of December 31, 2006, compared to euro 1.1 million as of December 31, 2005 and represents mainly returns on the financial investments of the Company's cash, cash equivalents and current financial instruments.
The income tax expense incurred by NicOx in 2006 relates principally to its Italian subsidiary and amounted to euro 0.3 million, compared to euro 0.2 million in 2005.
Net loss
Net loss increased by euro 9.2 million in 2006 to euro 24.7 million, compared to euro 15.5 million in 2005. This important increase in consolidated net loss, notwithstanding the increase in revenues recognized over the period, is due to the significant increase in operating expenses during 2006.
NicOx' debt is mainly short-term operating debt. As of December 31, 2006, its current liabilities amounted to euro 17.2 million, including euro 8.1 million of deferred revenues relating to payments received under collaboration agreements, euro 6.2 million in accounts payable to suppliers and external collaborators, euro 2 million in accrued compensation for employees, euro 0.7 million in taxes payable and euro 0.2 million in current income tax payable. NicOx had no loans outstanding and long-term financial leasing commitments amounted to euro 0.05 million as of December 31, 2006.
As of December 31, 2006, the Company's financial instruments, cash and cash equivalents amounted to euro 81.7 million, compared to euro 42.6 million as of December 31, 2005. 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' net burn rate, defined with reference to its 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 2006 amounted to euro 17.8 million, compared to euro 9.4 million in 2005. This significant increase in the Company's burn rate, notwithstanding the increase in payments relating to collaboration agreements received by the Company, for an aggregate amount of euro 17.2 million in 2006, is explained by the significant increase in the operational expenses incurred by the Company during this period.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven biopharmaceutical company dedicated to the development of nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of pain and inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.
NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).
The elements included in this communication may contain forward-looking statements subject to certain risks and uncertainties. Actual results of the company may differ materially from those indicated in the forward-looking statements because of different risks factors described in the company's document de reference.
NicOx: http://www.nicox.com Fiscal year ended December 31 2006 2005 (euro thousands except for per share data) Revenues 9,630 6,528 Cost of sales (1,605) (1,775) Research and development expenses (26,966) (16,201) Administrative and selling expenses (7,717) (4,888) Operating loss (26,658) (16,336) Net financial income 2,223 1,056 Loss before income tax (24,435) (15,280) Income tax expense (261) (228) Loss for the year (24,696) (15,508) Attributable to: - Equity holders of the Company (24,696) (15,508) - Minority interests - - Earnings per share for profit attributable to the equity holders of the Company during the year * Basic (0.69) (0.48) * Diluted (0.69) (0.48) CONSOLIDATED BALANCE SHEET Fiscal year ended December 31 2006 2005 (euro thousands) ASSETS Non-current assets Property, plant & equipment 1,900 1,444 Intangible assets 214 190 Government subsidies receivable 1,521 266 Other financial assets 141 148 Deferred income tax assets. 11 13 Total non-current assets 3,787 2,061 Current assets Trade receivables 2,142 2,172 Government subsidies receivables 708 708 Other current assets 1,670 1,724 Prepaid expenses 1,362 1,535 Current financial instruments 27,602 7,109 Cash and cash equivalents 54,138 35,476 Total current assets 87,622 48,724 TOTAL ASSETS 91,409 50,785 EQUITY Capital and Reserves attributable to equity holders of the Company Ordinary shares 7,610 6,429 Other reserves 66,302 32,606 Minority interests in equity - - Total Equity 73,912 39,035 LIABILITIES Non-current liabilities Provisions for other liabilities and charges 118 61 Deferred income tax liabilities 110 83 Finance lease 34 20 Total non-current liabilities 262 164 Current liabilities Provisions for other liabilities and charges 17 354 Finance lease 17 20 Trade payables 6,188 7,931 Deferred revenue 8,102 558 Current Income tax payable 209 176 Social security and other taxes 2,702 2,533 Other liabilities - 14 Total current liabilities 17,235 11,586 TOTAL LIABILITIES & SHAREHOLDERS' EQUITY 91,409 50,785
NicOx S.A.CONTACT: Karl Hanks, Manager of Corporate Relations and Market Analysis,+33-0-4-97-24-53-42, hanks@nicox.com; or Investors in the United States,Lisa Burns, lburns@burnsmc.com, or Laura Siino, +1-212-213-0006,lsiino@burnsmc.com, both of Burns McClellan; or Media, Jonathan Birt,+1-212-850-56-34, jbirt@fd-us.com, or Julia Phillips, +44-0-20-7831-3113,julia.phillips@fd.com, both of Financial Dynamics, all for NicOx S.A.
Web site: http://www.nicox.com/
