Nicox 2015 Half-Year Highlights

Transcription

1 Nicox 2015 Half-Year Highlights Michele Garufi Sandrine Gestin Gavin Spencer Chief Executive Officer Finance Director EVP Corporate Development August 28 th, 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 4 th chapter of the Document de référence, rapport financier annuel et rapport de gestion 2014 filed with the French Autorité des Marchés Financiers (AMF) on April 10, 2014, which is available on Nicox s website (

2 Building a leading Global Ophthalmic Company Vesneo : potential to become glaucoma blockbuster Partnered worldwide with Bausch + Lomb (Valeant) NDA submitted with FDA Significant revenue potential for Nicox Engine for NO-donating pipeline growth Further advanced proprietary pipeline AC-170: patented cetirizine eye drop formulation for allergic conjunctivitis; potential FDA approval expected by end NCX 4251: patented nanocrystalline fluticasone for blepharitis; expected to enter US phase 2 trials post-ind approval. Next generation NO-donors targeting glaucoma and reduction of IOP European commercial business Track record of revenue growth from diversified product portfolio Product launches planned throughout AzaSite and BromSite MAA filing planned by H

3 Vesneo : Significant revenue potential for Nicox U.S. glaucoma market valued at nearly $2.4 billion annually 1 Partnered with Bausch + Lomb (Valeant) o Provided peak sales guidance of >$500 million in U.S., >$1 billion WW 2 o Expands Valeant presence in chronic eye diseases Potential revenues from worldwide licensing agreement with Valeant o o $20 million paid to Nicox between 2010 and 2012 (upfront + 1st milestone) Remaining milestones up to $162.5 million ($132.5 million net) $30 million due to Pfizer in two payments, with majority of commercial milestones to Nicox o Potential tiered royalties to Nicox from 6% - 11% (net of single digit royalty to Pfizer) 1. IMS December 2014 (USC #61690 oph prostaglandins and miotics, #61660 oph beta blockers, #61650 oph carbonic anhydrase inhibitors) 2. Valeant corporate press release 09/26/14 3

4 Recent highlights NDA submitted by Bausch + Lomb (Valeant) to US FDA Two positive pre-nda meetings held with FDA for AC-170 Selection of promising NO-donating programs to advance towards clinical development AzaSite and BromSite in-licensed from InSite Vision Additional products launched to support sales revenue growth Financing completed in March 2015 with buy-in from major US and European life-science investors 4

5 Nicox s advanced pipeline beyond VESNEO Product Rights Preclinical Development Regulatory/Marketing Status AC-170 (cetirizine) Ocular itching associated with allergic conjunctivitis NCX 4251 (fluticasone propionate nanocrystals) Blepharitis NCX 470 (NO-bimatoprost) Glaucoma NCX 434, NCX 422 (NO-steroids) Diabetic Macular Edema and other ophthalmic indications Next generation NO-donors Glaucoma and other ophthalmic indications Core worldwide pipeline Potential FDA approval by end 2016 Expected to enter phase 2 pending IND approval Preclinical Preclinical Lead optimization AzaSite (1% azythromycin) Bacterial conjunctivitis EMEA 1 European pipeline European filing expected by H1 16 BromSite (0.075% bromfenac) Pain and inflammation after cataract surgery EMEA 1 European filing expected by H1 16 NCX (Carragelose) Viral conjunctivitis European launch expected in 2017 AAT (RPS-AP) Combined detection of adenoviral and allergic conjunctivitis 1. Europe Middle East Africa 2. Medical device 3. In vitro diagnostic medical device 5

6 H Financial highlights Revenues Cash, Cash Equivalents (incl. Financial Instruments) 90, * H restated H *excludes Nicox Inc. 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0, Dec 31, 2014 Jun 30, 2015 Figures in million euros ( x 1,000,000) Growing sales in all countries, with positive momentum expected to continue in H Recent financing strengthens cash position to ~ 40 million to support growth strategy No bank indebtedness 6

7 Consolidated statement of comprehensive income June 30, 2015 x 1000 June 30, 2015 June 30, 2014 Restated 1 Revenues 4,567 2,136* Cost of Sales (2,540) (1,695)* Operating Expenses (16,561) (10,909)* Operating Loss (14,534) (10,468)* Discontinued operations - (4,830) Net Loss (15,772) (15,964) *excludes Nicox Inc. 1 Following Nicox Inc. divestment Non audited 7

8 H Balance Sheet Consolidated Statement of Financial Position x 1000 June 30, 2015 Dec 31, 2014 Restated 2 Non-current assets 130, ,553 Other current assets 7,008 6,883 Cash, Cash equivalents and non-current financial instruments 39,528 31,872 Total Assets 177, ,308 Total Equity 119, ,548 Total Non-current Liabilities 50,496 44,666 Total Current Liabilities 7,576 9,093 Total Equity and Liabilities 177, ,308 2 Following purchase price allocation of Doliage and Nicox Ophthalmics Inc. (ex-aciex) Non audited 8

9 Key upcoming milestones Clinical & Regulatory Vesneo (latanoprostene bunod) NDA filing acceptance announcement imminent AzaSite and BromSite MAA filing planned by H AC-170 Potential FDA approval expected by end 2016 Corporate 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 9

10 Nicox Visible science Nicox S.A. Nicox Pharma Drakkar 2 Bât D 2405 Route des Dolines CS Sophia Antipolis Valbonne France T: +33 (0) F: +33 (0) Nicox Ophthalmics, Inc. 777 Main Street Suite 2160 Fort Worth Texas T: F: Nicox Research Institute S.r.l. Via Ariosto Bresso Milano Italy T: F: