Nicox 2014 Financial Results Michele Garufi Sandrine Gestin Gavin Spencer
Chief Executive Officer Finance Director EVP Corporate Development March 30th, 2015
This presentation 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. Risk 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 2013” filed with the French Autorité des Marchés Financiers (AMF) on April 2nd, 2014; the “Rapport semestriel financier et d’activité au 30 juin 2014”; the 5th chapter of the first “Actualisation du Document de Référence 2013” filed with the AMF on September 30, 2014 (D. 14-0271-A01); the section B of “Document E” registered with the AMF on September 30, 2014 (E.14-060); the 5th chapter of the “Seconde Actualisation du Document de Référence 2013” filed with the AMF on March 6, 2015 (D.14-0271-A01) and the chapter 2 of the “Note d'opération” filed with the AMF on March 6, 2015 (15080). All these documents are available on Nicox’s website (www.nicox.com).
Successful and continuing growth Nicox’s objective is to become a leading global specialty ophthalmic company, with an international commercial presence, a diversified product portfolio and an advanced therapeutic pipeline. • 1
Partnership with Bausch + Lomb on Vesneo™ • • •
2 •
Advanced proprietary pipeline • •
• 3
NDA filing anticipated Q2 2015 Potential to become glaucoma blockbuster Potential for significant milestones and royalties for Nicox
Lead late-stage US asset AC-170, novel cetirizine eye drop for allergic conjunctivitis; potential FDA approval expected by end 2016 Followed by AC-155, potentially the first bid steroid for post-operative pain and inflammation, expected to enter phase 2 trials post-IND approval
European commercial business • • •
Track record of revenue growth from diversified product portfolio Product launches planned throughout 2015-2018 AzaSite® and BromSite™ MAA filing planned by Q1 2016 2
2014 and early 2015 highlights • Positive efficacy results in pivotal Phase 3 trials for Vesneo™ reported by partner Bausch + Lomb (Valeant) • Successfully completed 3 acquisitions: • Aciex Therapeutics to bring in two wholly-owned advanced ophthalmology assets, including AC-170 • French ophthalmic company Doliage • Xailin Viral anti-viral eye drop (Carragelose)
• Launched seven European products and completed a sales infrastructure in the top five EU markets • Signed international partnerships in key markets including Japan • Sold U.S. diagnostics subsidiary to Valeant for up to $20 million in November 2014 • Financing of €27 million to support growth strategy 3
Products & pipeline overview Product
Registration / market
Est. launch
Glaucoma and ocular hypertension
NDA submission with US FDA est. Q2’15
2016
Ocular itching associated with allergic conjunctivitis
potential FDA approval by end 2016
2017
Therapeutic area
Development
Pre-registration
PARTNERED PRODUCTS Vesneo™ (latanoprostene bunod)
U.S.-FOCUSED PRODUCTS AC-170 (cetirizine)
AC-155 (fluticasone propionate)
Post-operative ocular pain and inflammation
–
SELECTED EUROPEAN PRODUCTS Xailin™ Range
Dry eye
Marketed
AdenoPlus®
Differential diagnosis of acute conjunctivitis
Marketed
Xailin Viral and Zared line extension
Antiviral and fortified food
2015-2016
AzaSite® (azythromycin)
BromSite™ (bromfenac) Therapeutic │
Bacterial conjunctivitis
MAA filing est. Q1’16
2017-2018
Pain and inflammation after cataract surgery
MAA filing est. Q1’16
2017-2018
Medical device │
Diagnostic device │
Nutraceutical / Fortified food 4
2014 Financial highlights Cash, Cash Equivalents
Revenues
(incl. Financial Instruments) 90 80
8
6*
7 6
58,5
60
48 32
40
4
30
3 1
70 50
5
2
77,5
20
0,4*
10
0
0 2013 restated
2014 *excludes Nicox Inc.
Dec 31, 2012
Dec 31, 2013
Dec 31, 2014
Mar 10, 2015
Figures in million euros (€ x 1,000,000)
•
Growing EU & RoW sales, with positive momentum expected to continue in 2015
•
Recent financing strengthens cash position to ~€48 million to support growth strategy
•
No bank indebtedness 5
Consolidated statement of comprehensive income December 31, 2014
2014
2013 Restated1
5 982*
436*
Cost of Sales
(3,938)*
(318)*
Operating Expenses
(23,824)*
(11,122)*
Operating Loss
(21,779)*
(11,003)*
Discontinued operations
(1,172)
(6,776)
Net Loss
(22,892)
(18,145)
€ x 1000 Revenues
*excludes Nicox Inc. 1
Following Nicox Inc. divestment
6
2014 Balance Sheet
2014
2013 Restated1
Non-current assets
92,486
10,855
Other current assets
6,883
2,849
Cash, Cash equivalents and non-current financial instruments
31,872
58,474
Total Assets
131,240
72,178
Total Equity
103,998
61,382
Total Non-current Liabilities
18,431
2,073
8,811
8,722
131,240
72,178
Consolidated Statement of Financial Position € x 1000
Total Current Liabilities Total Equity and Liabilities 1
Following purchase price allocation of Nicox Farma S.r.l
30/03/2015
7
Key upcoming milestones Clinical & Regulatory Milestones VESNEO (latanoprostene bunod) – FDA submission planned Q2 2015 AzaSite® and BromSite™ – MAA filing planned by Q1 2016 AC-170 – Potential FDA approval expected by end 2016 Naproxcinod – Update on evaluation by financial partner in DMD by mid-2015
Corporate Milestones Continued execution of EU commercial plan with positive sales momentum Additional European product launches in 2015 and onwards Further in-licensing and corporate development opportunities
8
Nicox Helping people to enhance their sight www.nicox.com
Nicox S.A. | Nicox Pharma
Aciex Therapeutics, Inc.
Nicox Research Institute S.r.l.
Drakkar 2 – Bât D 2405 Route des Dolines CS 10313 Sophia Antipolis 06560 Valbonne | France
777 Main Street | Suite 2160 Fort Worth | Texas 76102
Via Ariosto 21 20091 Bresso | Milano Italy
T: +33 (0)4 97 24 53 00 F: +33 (0)4 97 24 53 99
T: +1 817 529 9300 F: +1 817 612 6766
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