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|Nicox: First Half 2019 Financial Results and Business Update|
September 17, 2019 – release at 7:30 am CET
Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today reported the financial results for Nicox and its subsidiaries (the “Nicox Group”) for the six months ending June 30, 2019 and provided an update on its activities as well as key upcoming milestones.
Michele Garufi, Chairman and Chief Executive Officer of Nicox, said: “This is a compelling and potentially transformative time for Nicox, as we make strong progress in our growth strategy. Our two Phase 2 clinical trials have progressed in accordance with our expected timeline, with data expected early in the fourth quarter for our lead product candidate NCX 470 for glaucoma and later in the year for NCX 4251 in blepharitis. We are optimizing the value of our assets through licensing agreements outside of the U.S. and Europe, including the recent deal for NCX 4251 in the Chinese market, and continuing discussions with potential partners in several markets. With solid foundations in place, we are very much looking forward to continuing the exciting development of our company.”
Key Upcoming Clinical Milestones
Net revenue1 for the first half of 2019 was €5.6 million versus €0.3 million for the first half of 2018.
Operating expenses for the first half of 2019 were €11.4 million compared to €10.0 million for the first half of 2018. The increase in operating expenses was mainly due to costs associated with the two ongoing Phase 2 clinical trials for NCX 470 and NCX 4251.
|Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. By leveraging our proprietary expertise in nitric oxide (NO) donation and other technologies, we are developing an extensive portfolio of novel product candidates that target multiple ophthalmic conditions, including glaucoma. Our portfolio has three programs in development including NCX 470, a novel, second-generation NO-donating bimatoprost analog, for intraocular pressure lowering, based on our proprietary NO-donating research platform and NCX 4251, a proprietary formulation of the well-established molecule fluticasone, for acute exacerbations of blepharitis. Our research activities are focused on novel future generation NO-donors including NO-donating phosphodiesterase-5 (PDE5) inhibitors and NO-donating soluble guanylate cyclase (sGC) stimulators (in partnership with Cyclerion). In addition, we have two ophthalmology assets that have been approved by the U.S. Food and Drug Administration (FDA); VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, exclusively licensed worldwide to Bausch + Lomb, a Bausch Health Companies Inc. company, and commercialized in the U.S. by Bausch + Lomb since December 2017, as well as ZERVIATE™ (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals, LLC.
Nicox is headquartered in Sophia Antipolis, France, is listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol: COX) and is part of the CAC Healthcare, CAC Pharma & Bio and Next 150 indexes.
For more information on Nicox, its products or pipeline, please visit: www.nicox.com.
|Bryan, Garnier & Co Hugo Solvet Paris, France
H.C. Wainwright & Co Yi Chen New York, U.S.
Oppenheimer & Co Hartaj Singh New York, U.S.
|The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.|
|Bryan, Garnier & Co European Healthcare Conference 12 - 13 November, 2019 Paris
Actionaria, 21-22 November, 2019, Paris
Executive Vice President, Chief Business Officer
& Head of Corporate Development
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|Investors & Media
United States & Europe
LifeSci Advisors, LLC
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LifeSci Advisors, LLC
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|The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.
Risks factors which are likely to have a material effect on Nicox’s business are presented in the 4th chapter of the ‘Document de référence, rapport financier annuel et rapport de gestion 2018’ filed with the French Autorité des Marchés Financiers (AMF) on March 6, 2019 which are available on Nicox’s website (www.nicox.com).
Bât D, 2405 route des Dolines
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Interim Consolidated statement of Comprehensive Income
|6 Months period ending June 30,|
|(in thousands of €)|
|Revenues from collaborations||6,214||503|
|Net Profit from collaborations||5,590(1)||300 (1)|
|Research and development expenditures||(7,539)||(5,816)|
|Operating loss before amortization of intangible assets||(5,277)||(8,738)|
|Amortization of intangible assets||(17)||-|
|Net financial income/(expense)||744||1,184|
|Loss before tax||(4,550)||(7,554)|
|Income tax (expense) / benefit||3,799 (2)||(96)|
|Net loss for the period||(751)||(7,650)|
(1) Including €0.9 million of net royalties for the six months ended June 30, 2019 against €0.3 million for the six months ended June 30, 2018 and license fees for €4.7 million for the six months ended June 30 2019 against €0.0 million for the six months ended June 30, 2018.
(2) Non-cash income tax for deferred tax assets recognized by our U.S subsidiary.
Interim consolidated Statement of Financial Position
|As of June 30, 2019||As of Dec. 31, 2018|
|(in thousands of €)|
|Property, plant and equipment||694||269|
|Non-current financial assets||16,310||15,473|
|Total non-current assets||114,349||112,498|
|Government grants receivables||1,612||1,247|
|Other current assets||1,179||691|
|Cash and cash equivalents||17,354||22,059|
|Total current assets||26,712||26,092|
|EQUITY AND LIABILITIES|
|Cumulative translation adjustement||7,013||6,697|
|Non-current financial liabilities||6,921||54|
|Deferred tax liabilities||12,793||16,373|
|Total non-current liabilities||20,261||16,868|
|Current financial liabilities||945||31|
|Other current liabilities||1,732||2,425|
|Total current liabilities||6,378||8,069|
|TOTAL LIABILITIES AND EQUITY||141,061||138,590|