Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (November 2020)
26 slides from Nicox Sa's investor presentation, Nov 23, 2020
Slide 1: Corporate Presentation November 23, 2020
Corporate Presentation November 23, 2020 Innovative Solutions to Help Maintain Vision and Improve Ocular Health Euronext Paris: COX © 2020 Nicox. All rights reserved
Slide 2: Nicox Forward-Looking Statements
Nicox Forward-Looking Statements This document has been prepared by Nicox SA and may not be reproduced or distributed, in whole or in part. The information contained in this document has not been independently verified and no representation, warranty or undertaking, expressed or implied, is made as
Slide 3: Nicox – Investment in an Advanced Late-Stage Pipeline
Nicox – Investment in an Advanced Late-Stage Pipeline Two Advanced Clinical Programs Steadily Increasing Revenue from Partnerships • NCX 470 Phase 3 program in glaucoma - • Cash runway beyond top-line results of same dual mechanism of action as first ongoing Mont Blanc NCX 470 Phase 3 trial generati
Slide 4: Pipeline
Pipeline Stages of Development Products and product candidates/ Indications Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed Main partners Markets NO-Donating Product Candidates Targeting Glaucoma NCX 470 second generation NO-donating bimatoprost analog Chinese market Glaucoma NCX 1728 novel NO-medi
Slide 5: Novel Nitric Oxide-Donating Phase 3 Product Candidate in Glaucoma
Novel Nitric Oxide-Donating Phase 3 Product Candidate in Glaucoma NCX 470 5
Slide 6: U.S. Glaucoma Pharmaceuticals Market Worth ~$3 Billion
U.S. Glaucoma Pharmaceuticals Market Worth ~$3 Billion1 Glaucoma is the Largest Eye Drop Market Worldwide NCX 470 Targets $1.5 Billion U.S First-line Glaucoma Market ZIOPTAN 39 17 XALATAN (tafluprost) (latanoprost) • Branded PGA products still VYZULTA 61 (latanoprostene bunod) account for nearly 90%
Slide 7: NCX 470 – De-Risked Phase 3 Program in Glaucoma
NCX 470 – De-Risked Phase 3 Program in Glaucoma Superiority to Latanoprost • Novel second generation NO-donating bimatoprost analog • Same dual mechanism of action as the approved product VYZULTA • Already demonstrated statistical superiority to standard-of-care latanoprost in a large Phase 2 clinic
Slide 8: NCX 470's Dual Mechanism of Action
NCX 470’s Dual Mechanism of Action bimatoprost 6-(nitrooxy)hexanoic acid Nitric Oxide NCX 470 cGMP: cyclic guanosine monophosphate PKG: protein kinase G 8
Slide 9: NCX 470 Dolomites Phase 2 Trial Showed Superiority to Latanoprost
NCX 470 Dolomites Phase 2 Trial Showed Superiority to Latanoprost The Dolomites U.S. multicenter, dose-response Phase 2 clinical trial evaluated NCX 470 ophthalmic solution (0.021%, 0.042% and 0.065%), compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or oc
Slide 10: NCX 470 Showed Statistical Superiority at Two Doses vs. Latanoprost
NCX 470 Showed Statistical Superiority at Two Doses vs. Latanoprost in Mean Diurnal IOP Allowed Higher Dose to Be Evaluated • NCX 470 dose response showed improved IOP with each incremental concentration of NCX 470 (*p<0.05, **p=0.0009) • Conjunctival hyperemia dose response plateaued at the middle
Slide 11: NCX 470 – Phase 3 Program in Glaucoma
NCX 470 – Phase 3 Program in Glaucoma • Mont Blanc, first Phase 3 clinical trial initiated in the U.S. on June 1, 2020 • 0.1% dose selected over 0.065% NCX 470 dose in the completed adaptive stage of ongoing Mont Blanc Phase 3 trial in patients with open-angle glaucoma or ocular hypertension: adapti
Slide 12: U.S. Glaucoma Clinical Advisory Board with Leading Experts
U.S. Glaucoma Clinical Advisory Board with Leading Experts Professor and Chair of the Department of Ophthalmology at SUNY Upstate Medical Dr. Robert D. Fechtner, MD Chairman University, Syracuse, NY Kittner Family Distinguished Professor and Chairman, Department of Ophthalmology, UNC Dr. Donald Bude
Slide 13: NCX 470 vs Current First-line Glaucoma Therapies
NCX 470 vs Current First-line Glaucoma Therapies Phase 2 trial with NCX 470 0.065% QD: 7.6 to 9.8 mmHg IOP reduction, 16.8% hyperemia XALATAN1 LUMIGAN1 TRAVATAN Z1 VYZULTA2 ROCKLATAN1 (latanoprost (bimatoprost 0.01%) (travoprost 0.004%) (latanoprostene (latanoprost 0.005% 0.005%) bunod 0.024%) and n
Slide 14: NCX 470 Market Survey with 40 Prescribers and Payers
NCX 470 Market Survey with 40 Prescribers and Payers Potential U.S. Statistical superiority to latanoprost 0.005% (displayed in Potential U.S. peak net sales peak share of U.S. FDA-approved label) based on head-to-head Phase 3 (assuming industry-standard branded PGA trials discounting for the catego
Slide 15: NCX 1728: First in a New Class of NO-mediated IOP Lowering Agents
NCX 1728: First in a New Class of NO- mediated IOP Lowering Agents 14
Slide 16: NCX 1728 – Lead Compound of New Class of IOP Lowering Agents
NCX 1728 – Lead Compound of New Class of IOP Lowering Agents Molecules in this new class showed robust IOP lowering in a non-human primate model of ocular hypertension NCX 1741, an analog of NCX 1728, lowers IOP in ocular hypertensive non- human primates1 • First in a new class of compounds in which
Slide 17: Novel Route of Delivery and Formulation Targeting Blepharitis
Novel Route of Delivery and Formulation Targeting Blepharitis NCX 4251 17
Slide 18: NCX 4251 in Blepharitis - An Unmet Medical Need
NCX 4251 in Blepharitis - An Unmet Medical Need Ophthalmic Suspension of Fluticasone Propionate Nanocrystals • An opportunity to provide first-in-class therapy for acute exacerbations of blepharitis • No U.S. FDA-approved product solely indicated for blepharitis • 37% and 47% of all patients seen by
Slide 19: Danube Phase 2 Trial Positive Proof of Concept Results
Danube Phase 2 Trial Positive Proof of Concept Results NCX 4251 0.1% once daily treatment selected to advance into a larger Phase 2 trial • Danube was a U.S. multi-center, randomized, double-masked, placebo-controlled, dose escalating trial in 36 patients with acute exacerbations of blepharitis • No
Slide 20: Validating Chinese Partnership
Validating Chinese Partnership Ocumension is a publicly traded Chinese ophthalmology company, listed on HKEX at ~$2 billion market cap to date, whose investors include 6 Dimensions Capital, Orbimed and HBM. Ocumension has exclusive rights1 in China and certain South East Asian markets across Nicox’s
Slide 21: Key Commercial Partnerships
Key Commercial Partnerships VYZULTA® ZERVIATETM (Glaucoma) (Allergic Conjunctivitis) • First eye drop with a new mechanism of • First and only topical ophthalmic action approved in 20 years formulation of cetirizine • Partnered worldwide with Bausch + • Launched in the U.S. in March 2020 by Lomb U.S
Slide 22: Corporate
Corporate Financial Highlights Key Milestones Board of Directors 22
Slide 23: Financial Highlights
Financial Highlights Cash Position Shares Cash & Cash Equivalents1 €42.2 million Outstanding shares2 ~33.5 million Debt4 €19.2 million Fully diluted shares3 ~35 million Free float ~98% HBM 7.2% Key Investors Orbimed 5.7% 1. As of September 30, 2020. Unaudited figure 2. 3. Existing outstanding shares
Slide 24: Key Upcoming Milestones
Key Upcoming Milestones Q4 2020: NCX 4251 Start Phase 2 clinical trial (‘Mississippi’) in the U.S. Q4 2020: ZERVIATE Ocumension starts Phase 3 clinical trial in China to support Chinese NDA submission Q4 2021: NCX 470 Top-line results from first Phase 3 clinical trial (‘Mont Blanc’) Q4 2021: NCX 425
Slide 25: Board of Directors with U.S. Experience
Board of Directors with U.S. Experience Michele Garufi Co-Founder, Chairman and Chief Executive Officer Adrienne Graves Director Les Kaplan Director Jean-François Labbé Director Luzi von Bidder Director Lauren P. Silvernail Director 25
Slide 26: Innovative Solutions to Help Maintain Vision and Improve Ocular Health
Innovative Solutions to Help Maintain Vision and Improve Ocular Health Nicox S.A. Nicox Research Institute S.r.l. Nicox Ophthalmics, Inc. Drakkar 2 – Bât. D Via Ariosto 21 4721 Emperor Blvd. Suite 260 2405 Route des Dolines 20091 Bresso Durham, NC 27703, U.S. CS 10313 Sophia Antipolis Milano, Italy