Press Release

Nicox Announces 2018 Financial Results and 2019 Milestones

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  • Net revenue1 increased by 74%
  • Loss before tax in 2018 reduced compared to 2017
  • Cash balance and 2019 loan financing provide strong foundation for rapid advancement of Nicox's clinical-stage programs


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March 6, 2018 - release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the financial and operating results for Nicox and its subsidiaries (the "Nicox Group") for the year ended December 31, 2018, as approved by the Board of Directors on March 5, 2019, and provided upcoming 2019 milestones.

2018 Financial Summary

In 2018, the Loss before tax of the Nicox Group was €18.3 million compared to €19.1 million in 2017.  This reduction was achieved despite the significant investments in research and development made in 2018.  

Net revenue for the 12 months to December 2018 was €4.0 million, which consists of the upfront payment from Ocumension Therapeutics for the license of NCX 470 for the Chinese market and net royalties on sales of VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% by global partner Bausch + Lomb.  This compares to a Net revenue for the 12 months to December 2017 of €2.3 million.

Operating expenses for the period 2018 increased to €26.5 million from €20.8 million for the 12 months to December 31, 2017 mainly due to investments in the development of our wholly-owned programs, NCX 470 and NCX 4251.

As of December 31, 2018, the Nicox Group had cash and cash equivalents of €22.0 million as compared with €41.4 million at December 31, 2017.

Event after the Reporting Period

On January 25, 2019, Nicox entered into a bond financing for up to €20 million from Kreos Capital, which together with cash on hand and anticipated royalties potentially extends the Company's cash runway into 2021.  The financing is structured as three tranches of which only the first tranche of €8 million has been drawn down.  The exercise of the two other tranches is at Nicox's sole discretion.

Upcoming 2019 Milestones

  • NCX 470: Top-line results from the Phase 2 clinical study for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension expected in Q4 2019.
  • NCX 4251: Phase 2 clinical study in patients with acute exacerbations of blepharitis to start shortly, with top-line results expected in Q4 2019.
  • ZERVIATETM U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. by our U.S. partner Eyevance Pharmaceuticals expected in summer 2019.
  • ZERVIATE ex-US partnering: Potential new licensing agreements, with multiple discussions ongoing.
  • Presentations on Nicox's ophthalmology programs at key scientific conferences including the American Glaucoma Society (AGS), the Association for Research in Vision and Ophthalmology (ARVO).

Note

  1. Net revenue consists of revenue from collaborations less royalty payments which corresponds to Net profit in the consolidated statements of profit or loss

About Nicox

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 includes three programs in development including NCX 470 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 Ironwood).  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(TM) (cetirizine ophthalmic solution), 0.24%, exclusively licensed in the U.S. to Eyevance Pharmaceuticals.  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

Analyst coverage

Bryan, Garnier & Co   Hugo Solvet                 Paris, France
H.C. Wainwright & Co Yi Chen                        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.

Upcoming financial and business conferences
 

March 11-13  Cowen 39th Annual Health Care Conference  Boston, U.S. 

March 19-20  Oppenheimer's 29th Annual Healthcare Conference  New York, U.S. 

April 7-9  H.C. Wainwright Global Life Sciences Conference  London, UK

April 16-17  SmallCap Event    Paris, France

May 16  European MidCap Event  Copenhagen, Denmark

June 2-6  BIO 2019  Philadelphia, U.S.

June 18-19  European MidCap Event  Paris, France

Contacts

Nicox
Gavin Spencer,
Executive Vice President, Chief Business Officer
& Head of Corporate Development  
T +33 (0)4 97 24 53 00
communications@nicox.com

Investors & Media
United States & Europe
LifeSci Advisors, LLC
Hans Herklots
T +41 79 598 71 49  
hherklots@lifesciadvisors.com
Media
France
LifeSci Advisors, LLC
Sophie Baumont
M +33 (0)6 27 74 74 49
sophie@lifesciadvisors.com
   
Disclaimer
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 2017' filed with the French Autorité des Marchés Financiers (AMF) on March 19, 2018, which are available on Nicox's website (www.nicox.com).
Nicox S.A.
Drakkar 2
Bât D, 2405 route des Dolines
CS 10313, Sophia Antipolis
06560 Valbonne, France
T +33 (0)4 97 24 53 00
F +33 (0)4 97 24 53 99


Consolidated statements of profit or loss 

                                                                                          

  As of December 31:
  2018 2017
     
Revenue from collaborations  4,717 15,080
Royalty payments

 
(690) (12,775)*
Net profit 4,027  2,305
Research and development expenditures (16,331)  (9,750)
Administrative expenses (9,506)  (9,869)
Other income 1,786  987
Other expenses (644) (1,207)
Operating loss before changes in fair value of contingent consideration (20,668)  (17,534) 
Fair value adjustment of contingent consideration - (984)**
Operating loss (20,668)  (18,518) 
Finance income 2,461  1,314
Finance expense  (71) (1,908)
Net financial income, (expenses) 2,390  (594)
     
Loss before tax from continuing operations  (18,278)  (19,112)
     
Income tax (expense) / benefit (113)  10,815***
     
Loss after tax from continuing operations (18,391)  (8,296)
Profit from the period from discontinued operations (net of tax) - 4,678
Loss for the period (18,391)  (3,618)
     

* includes a milestone and royalties  

** non-cash impact of the reduction in the value of a potential earn-out payable in shares to Nicox Ophthalmics Inc. former shareholders.

*** non-cash impact of the reduction of deferred tax liability related to Nicox Ophthlamics Inc. following the new US tax law voted in December 2017        

    

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION                                                                 

 

 
As of December 31:
  2018 2017[1]
ASSETS    
Non-current assets    
Goodwill 25,359  24,211
Intangible assets 71,397  68,155
Property, plant and equipment 269  158
Non-Current financial assets 15,473  13,990
Total non-current assets 112,498  106,614
     
Current assets    
Trade receivables 616  44
Government grants receivables 1,247  948
Other current assets  691 523
Prepayments 1,479  1,381
Cash and cash equivalents 22,059  41,394
Total current assets 26,092  44,290
TOTAL ASSETS 138,590  150,804
     
EQUITY AND LIABILITIES    
Shareholders' equity    
Issued capital 29,719  29,459
Share premium 510,683  510,942
Cumulative translation adjustement 6,697  3,973
Accumulated deficit (433,445)  (417,607)
Total equity  113,653 126,767
Non-current liabilities    
Non-current financial liabilities 54  26
Deferred taxes liabilities 16,373  15,631
Provisions 441  401
Total non-current liabilities 16,868  16,059
Current liabilities    
Current financial liabilities 31  24
Trade payables 4,281  1,929
Deferred income 1,256  4,184
Provisions 76  40
Other current liabilities  2,425 1,801
Total current liabilities 8,069  7,978
TOTAL LIABILITIES AND EQUITY 138,590  150,804




       [1] The Group retrospectively applied IFRS 9 on January 1, 2018 and consequently assessed an expected credit loss for the notes receivable issued by VISUfarma.  Accordingly, the Group decreased the value of the notes receivable by €1.4 million and restated the lines "Non-current financial assets" and "Accumulated deficit" as of December 31, 2017 in the consolidated statements of financial position.


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