Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (December 2020)
33 slides from Nicox Sa's investor presentation, Dec 9, 2020
Slide 1: Corporate Presentation
Corporate Presentation December 9, 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: Investment Highlights
Investment Highlights • Same mechanism-of-action as our first FDA approved/U.S. marketed product Lead asset NCX 470, • Large Phase 2 trial achieved statistical superiority to market leader, with comparable safety a potential best-in-class glaucoma treatment • Two Phase 3 trials ongoing, designed for
Slide 4: Pipeline
Pipeline Stages of Development Expected Products and product candidates/ Indications Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed milestones NO-Donating Product Candidates Targeting Glaucoma Phase 3 top- NCX 470 novel NO-donating prostaglandin line results Q4 analog | Glaucoma 2021 Chinese marke
Slide 5: Novel Nitric Oxide-Donating Phase 3 Product Candidate in Glaucoma
Novel Nitric Oxide-Donating Phase 3 Product Candidate in Glaucoma NCX 470 © 2020 Nicox. All rights reserved
Slide 6: Glaucoma Results in Progressive and Irreversible Vision Loss
Glaucoma Results in Progressive and Irreversible Vision Loss Normal Reduced aqueous aqueous humor humor outflow outflow Healthy eye Intraocular Pressure (IOP) build up Typical effect of glaucoma on vision ~3 million patients in the U.S. with open angle glaucoma1 Unmet medical need: 40% of patients f
Slide 7: NCX 470 Targets $1.5 Billion First-Line U.S. Glaucoma Market
NCX 470 Targets $1.5 Billion First-Line U.S. Glaucoma Market U.S. Glaucoma Pharmaceuticals Market is ~50% of the Global Market2 PGA Prescription Volume1 PGA Prescription Value2 TRAVATAN (travoprost) 32% VYZULTA (latanoprostene LUMIGAN (bimatoprost) bunod) 13% 4% ZIOPTAN (tafluprost) Latanoprost 18.8
Slide 8: NCX 470 Targets the Two Key Outflow Pathways for Lowering IOP
NCX 470 Targets the Two Key Outflow Pathways for Lowering IOP 1 Primary or conventional outflow stimulated by NO. The primary route normally accounts for 60% to 80% of outflow 2 Secondary or uveoscleral outflow stimulated by PGAs. The secondary route normally accounts for 20% to 40% of outflow 8
Slide 9: NCX 470: Potential Best-in-Class Profile - Phase 2 Summary
NCX 470: Potential Best-in-Class Profile - Phase 2 Summary Dolomites Clinical Trial The Dolomites trial was a U.S. multicenter, dose-response Phase 2 clinical trial evaluating NCX 470 ophthalmic solution (0.021%, 0.042% and 0.065%), compared to latanoprost ophthalmic solution, 0.005% in 433 patients
Slide 10: NCX 470: Statistical Superiority to Latanoprost in IOP lowering
NCX 470: Statistical Superiority to Latanoprost in IOP lowering Linear Dose Response Laid Foundation for Testing 0.1% Dose in Phase 3 N=433 IOP NCX 470 dose response IOP latanoprost • NCX 470 dose response showed improved IOP lowering with each incremental concentration (*p<0.05, **p=0.0009) • Conju
Slide 11: NCX 470: Broad Phase 3 Program Ongoing with First Results in 2021
NCX 470: Broad Phase 3 Program Ongoing with First Results in 2021 Mont Blanc and Denali Phase 3 trial design Mont Blanc, initiated in June 2020, also included an initial adaptive design in which the 0.1% dose was chosen Denali, initiated in November 2020, will include a subsequent long-term safety e
Slide 12: NCX 470 Potential in First-Line Glaucoma Market in U.S.
NCX 470 Potential in First-Line Glaucoma Market in U.S. EXISTING MARKET: $1.5 billion4 NCX 470 Traditional1 PGAs VYZULTA (latanoprostene bunod ROCKLATAN (netarsudil and 0.1% in Phase 3 trials compared ophthalmic solution), 0.024%2 latanoprost ophthalmic solution) to latanoprost 0.005% 0.02%/0.005%1
Slide 13: 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 © 2020 Nicox. All rights reserved
Slide 14: NCX 1728: First Compound in a New Class of IOP Lowering Agents
NCX 1728: First Compound in a New Class of IOP Lowering Agents Molecules in this new class showed robust IOP lowering in a non-human primate model of ocular hypertension • First in a new class of compounds (non-PGA related) with NO-mediated IOP lowering effects enhanced and prolonged by concomitant
Slide 15: Novel Route of Delivery and Formulation To Address Unmet Medical Need in Blepharitis
Novel Route of Delivery and Formulation To Address Unmet Medical Need in Blepharitis NCX 4251 © 2020 Nicox. All rights reserved
Slide 16: NCX 4251 in Blepharitis - An Unmet Medical Need
NCX 4251 in Blepharitis - An Unmet Medical Need Blepharitis: inflammation of the eyelids, a chronic, difficult to treat condition: • No U.S. FDA-approved treatments available for acute exacerbations of blepharitis • Prevalence: ~37% - 47% of patients seen by U.S. ophthalmologists / optometrists1 • E
Slide 17: Danube Phase 2 Trial
Danube Phase 2 Trial Positive Proof-of-Concept Results in Acute Exacerbations of Blepharitis Danube was a U.S. multi-center, randomized, double-masked, placebo-controlled, dose escalating (once daily and twice daily) trial in 36 patients with acute exacerbations of blepharitis Statistically signific
Slide 18: Corporate
Corporate Key Partnerships Financial Highlights Anticipated Value-Creating Milestones © 2020 Nicox. All rights reserved
Slide 19: Portfolio Validated by Chinese Partnership
Portfolio Validated by Chinese Partnership Ocumension is a public Chinese ophthalmology company, listed on HKEX, ~$2B market cap: largest shareholder is founding investor 6 Dimensions Capital. Ocumension has exclusive rights1 in China and certain Southeast Asian markets on three key Nicox assets • R
Slide 20: Key Commercial Partnerships
Key Commercial Partnerships VYZULTA (Glaucoma) ZERVIATE (Allergic Conjunctivitis) Partnered with Bausch + Lomb worldwide Partnered with Eyevance in the U.S. • First eye drop approved in 20 years with a • First and only topical ophthalmic formulation of novel approach to reduce IOP cetirizine • Comme
Slide 21: Overview of Global Partnerships
Overview of Global Partnerships Product Partner Licensed Territories Milestones Future Milestones & Royalties Current Status Received NCX 470 Ocumension China region and South €18 million + half of 6% to 12% royalties Phase 3 East Asian markets Denali costs NCX 4251 Ocumension China region $2.3 mill
Slide 22: Key patents
Key patents Composition-of-matter patent to 2029 broadly filed, potentially eligible for up to a 5-year NCX 470 patent term extension in the U.S. Formulation patent granted in U.S., Europe and Japan with patent protection to 2039 Patents covering fluticasone propionate nanocrystal suspensions expiri
Slide 23: Financial Highlights
Financial Highlights Financial Position as of November 30, 20201 Analyst Coverage Cash, Cash Equivalents and ~€53 million Bryan Garnier Victor Floc’h Financial Instruments1 Cantor Fitzgerald Louise Chen Debt2 €18.7 million H.C. Wainwright Yi Chen Cash runway Beyond Next Value Inflection Points: Read
Slide 24: Anticipated Value-Creating Milestones
Anticipated Value-Creating Milestones 2020 2021 / 2022 NCX 470 Start first Phase 3, Mont Blanc, in glaucoma NCX 470 Mont Blanc and Denali enrollment updates NCX 470 Selection of Phase 3 dose NCX 470 Mont Blanc Phase 3 top-line results – Q4 2021 NCX 470 Start second Phase 3, Denali, in glaucoma
Slide 25: Investment Highlights
Investment Highlights • Same mechanism-of-action as our first FDA approved/U.S. marketed product Lead asset NCX 470, • Large Phase 2 trial achieved statistical superiority to market leader, with comparable safety a potential best-in-class glaucoma treatment • Two Phase 3 trials ongoing, designed for
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
Slide 27: Back-up: Management and Boards
Back-up: Management and Boards Management Board of Directors Glaucoma Clinical Advisory Board © 2020 Nicox. All rights reserved
Slide 28: U.S. Glaucoma Clinical Advisory Board with Leading Experts
U.S. Glaucoma Clinical Advisory Board with Leading Experts Dr. Robert D. Fechtner, MD Professor and Chair of the Department of Ophthalmology at SUNY Upstate Medical University, Syracuse, Chairman NY Kittner Family Distinguished Professor and Chairman, Department of Ophthalmology, UNC Chapel Hill Dr.
Slide 29: Experienced Management Team
Experienced Management Team Michele Garufi 40 years of experience in management, marketing and Co-Founder, Chairman and Chief international licensing in the pharmaceutical industry Executive Officer Gavin Spencer, Ph.D. 25 years of management and operational experience in EVP, Chief Business Officer
Slide 30: 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 30
Slide 31: Existing First-Line Glaucoma Therapies and NCX 470 Market Potential
Existing First-Line Glaucoma Therapies and NCX 470 Market Potential © 2020 Nicox. All rights reserved
Slide 32: NCX 470 vs Current PGA Glaucoma Therapies in the U.S.
NCX 470 vs Current PGA Glaucoma Therapies in the U.S. XALATAN1 LUMIGAN1 TRAVATAN Z1 VYZULTA2 ROCKLATAN1 (latanoprost 0.005%) (bimatoprost 0.01%) (travoprost 0.004%) (latanoprostene (netarsudil and bunod), 0.024% latanoprost ophthalmic solution) 0.02%/0.005% IOP reduction 6 to 8 mmHg Up to 7.5 mmHg 7
Slide 33: NCX 470 U.S. Market Survey with Prescribers and Payers
NCX 470 U.S. Market Survey with 40 Prescribers and Payers1 Up to $540 million peak sales potential in the U.S. Potential U.S. peak share Potential U.S. peak net sales Statistical superiority to latanoprost 0.005% (displayed in U.S. of branded PGA market (assuming industry-standard FDA-approved label