Nicox first half 2017 business and financial update

Press Release
Nicox first half 2017 business and financial update
  • ZERVIATE TM (cetirizine ophthalmic solution), 0.24% New Drug Application (NDA) approved
  • Investigational New Drug (IND) submissions for NCX 470 for IOP lowering and NCX 4251 for blepharitis planned for H1 2018
  • Bausch + Lomb responded to VYZULTA TM (latanoprostene bunod ophthalmic solution), 0.024% Complete Response Letter (CRL) received from U.S. Food and Drug Administration (FDA)
  • Gross proceeds from financing of €26.25 million
September 8, 2017 - release at 7:30 am CET
Sophia Antipolis, France


Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced its financial results for the six months ended June 30, 2017, and provided an update on its activities.

"The first half of 2017 was marked by significant developments across our core programs" commented Michele Garufi, Chairman and Chief Executive Officer of Nicox .   "The recent FDA approval of the ZERVIATE(TM) NDA brings us one step closer to our objective of securing a commercialisation partner for this innovative ophthalmic product for the U.S. market.  For VYZULTA(TM), our partner Bausch + Lomb has resolved the FDA's concerns surrounding their Tampa manufacturing plant and rapidly submitted a response to the CRL received in August."

Michele Garufi concluded, "Subsequent to the close of the second quarter, we strengthened our balance sheet through a reserved capital increase of ordinary shares, the gross proceeds of which were €26.25 million.  These funds allow us to advance our novel, patented pipeline candidates NCX 470 and NCX 4251 and to submit INDs for Phase 2 clinical studies during the first semester 2018."

Second Quarter 2017 and Recent Developments

  • In August 2017, Nicox completed a financing through a reserved capital increase of ordinary shares of the Company with a specific category of investors.  Gross proceeds from the financing were €26.25 million.
  • On August 7, 2017, Nicox's licensee Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) announced that it had received a CRL from the FDA concerning the NDA for VYZULTA TM (latanoprostene bunod ophthalmic solution), 0.024% for intraocular pressure lowering in patients with open angle glaucoma or ocular hypertension.  The CRL from the FDA referred to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida.  Bausch + Lomb has informed Nicox that it submitted its response to the FDA on August 17, 2017.  The NDA had been resubmitted to the FDA by Bausch + Lomb in February 2016 following receipt of a previous CRL.  Neither CRL issued to Bausch + Lomb mentioned any efficacy or safety issues with respect to the NDA for VYZULTA, nor any additional clinical trials for the approval of the NDA. 
  • On May 31, 2017, Nicox announced that the FDA had approved the NDA for ZERVIATE(TM) (cetirizine ophthalmic solution 0.24%; formerly AC-170), the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis.  Nicox is currently seeking a licensing partner for commercialization in the United States.   
Other Updates

  • Nicox and VISUfarma have amended certain elements of our agreement relating to the August 2016 transfer of Nicox's European and International commercial operations to VISUfarma.  Under the terms of the amended agreement, VISUfarma and Nicox have agreed to amend the terms and conditions related to the €5 million potential milestone payments, which would have been made in a combination of ordinary shares and interest-bearing loan notes.  As a result, Nicox will receive an additional €1.65 million in deal consideration in a combination of ordinary shares and interest-bearing loan notes, making the total consideration for the assets equal to an aggregate of €22.65 million, increased from the €21 million initially.  Nicox is now eligible to receive a milestone payment of up to €3.35 million in a combination of ordinary shares and interest-bearing loan notes if certain business objectives are achieved by VISUfarma.  Nicox and VISUfarma also agreed that Nicox will no longer be responsible for completing development and regulatory approval for NCX 4240 in Europe.  No payments are due by either party, now or subsequently, as a result of this change.  Nicox retains rights to develop NCX 4240 in the United States and Japan.  And finally, Nicox will make a one-time cash payment of €479,000 to VISUfarma.  
H1 2017 Financial Summary

Following reclassification in 2016 of the European commercial business as Discontinued Operations, the operating profit and loss account items described below include only the Continuing Operations.

  • The operating expenses for the six month period ended June 30, 2017 were €10.2 million compared to €12.0 million for same period ended June 30, 2016.  The decrease in operating expenses in 2017 is mainly due to the significant R&D expenses recorded during the first six months in 2016 due to the filing of an NDA for ZERVIATE TM with the FDA as well as expenses for additional studies undertaken to address potential questions of the FDA as part of their review of this application. 
  • The Group recorded a net loss from continuing operations of €12.2 million as of June 30, 2017, compared to a net loss of €12.9 million for the same period in 2016.
The Group had cash, cash equivalents of €20.4 million as of June 30, 2017, compared to €28.9 million on December 31, 2016.  Following the closing of the €26.25 million financing announced on August 15, 2017, the Group's cash, cash equivalents as of August 31, 2017 are estimated to be €44,07 million (non-audited figures).
About Nicox
Nicox S.A. is an international ophthalmic company developing innovative solutions to help maintain vision and improve ocular health. By leveraging its proprietary expertise in nitric oxide donation and other technologies, the Company is developing an extensive portfolio of novel drug candidates that target multiple ophthalmic conditions, including glaucoma. Nicox currently has one product at the review stage with the U.S. Food and Drug Administration (FDA), VYZULTA TM (latanoprostene bunod ophthalmic solution) 0.024%, licensed worldwide to Bausch + Lomb, and one product with an approved New Drug Application (NDA), ZERVIATE TM (cetirizine ophthalmic solution) 0.24%.  In addition our promising drug-candidate pipeline includes clinical stage assets based both on our proprietary NO-donating research platform and on the repurposing of existing molecules as well as a next-generation of stand-alone nitric-oxide donors and exploratory novel NO-donating compounds with the potential to offer novel approaches to treat a range of ophthalmic conditions. 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: .            
Analyst coverage
Bryan, Garnier & Co   Hugo Solvet                 Paris, France
Invest Securities          Martial Descoutures    Paris, France
Gilbert Dupont             Damien Choplain        Paris, France

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.
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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 2016 ' filed with the French Autorité des Marchés Financiers (AMF) on March 29, 2017, and in the updated and additional risk factors as of August 14, 2017, which are available on Nicox's website (
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Interim Consolidated statement of Comprehensive Income

  6 Months period ending June 30,
  2017 2016
  (in thousands of € except for per share data)
Selling expenses-(97)
General and administrative expenses(5,078)(4,376)
Research and development expenses(5,091)(6,544)
Other operating income344284
Other operating expense(75)(981)
Total operating income (loss) before fair value changes of contingent consideration ,and impairment of intangible asserts (9,900) (11,706)
Fair value changes of contingent considerations(1,688)(995)
Total operating income (loss) (11,588) (12,702)
Finance income60454
Finance costs [1] (1,164)(241)
Net finance revenues (560) (186)
Loss before tax (12,148) (12,888)
Income tax(20)(18)
Loss from continuing operations (12,168) (12,906)
Loss from discontinued operations [2] -(11,307)
Net loss for the year (12,168) (24,213)
Attributable to owners of the Company(12,168)(24,213)
Total comprehensive income (loss) for the period, net of tax (0,48) (1,06)
Basic/diluted earnings per share from continuing operations (€/share)(0,48)(0,56)
Basic/diluted earnings per share from discontinued operations (€/share)-(0,49)


Interim consolidated Statement of Financial Position

  As of June 30, 2017 As of Dec. 31, 2016
  (in thousands o f €)
Non-current assets   
Intangible assets71,64677,654
Property, plant and equipment183204
Non-current financial assets13,10212,652
Total non-current assets 110,375 118,056
Current assets   
Trade receivables69104
Government grants receivables687396
Other current assets5811,164
Cash and cash equivalents20,44328,859
Total current assets 22,699 30,692
TOTAL ASSETS 133,074 148,748
Equity attributable to equity holders of the parent   
Issued capital25,67025,005
Share premium490,222483,745
Accumulated deficit(425 828)(415,591)
Treasury shares-(478)
Currency translation adjustements7,26311,868
Total Equity 97,327 104,549
Non-current liabilities   
Non-current financial liabilities1730
Non-current financial liabilities related to business combination704923
Deferred taxes liabilities27,16429,409
Total non-current liabilities 28,326 30,819
Current liabilities   
Current financial liabilities3632
Current financial liabilities related to business combination-5,234
Trade payables2,0631,338
Deferred income3,6154,275
Other current liabilities1,6672,462
Total current liabilities 7,421 13,380

[1] Increase compared to H1 2016 is due mainly to an unrealized loss on the debt in dollars Nicox Ophthalmics, Inc. has with Nicox S.A.

[2] Following Nicox European commercial operations divestment

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Source: NICOX via GlobeNewswire