Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (July 2024)
27 slides from Nicox Sa's investor presentation, Jul 15, 2024
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health July 15, 2024 Euronext Growth Paris: ALCOX September 2022
Slide 2: Forward-looking statements
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 to, an
Slide 3: Progress in achieving value inflection points expected for 2024-2025
Progress in achieving value inflection points expected for 2024-2025 1 Appointment of Gavin Spencer as Chief Executive Officer Value proposition of NCX 470 confirmed through Kowa partnership NICOX visible science Restructuring of debt agreements with BlackRock Streamlining costs to concentrate on NC
Slide 4: Consistently delivering innovations in ophthalmology
Consistently delivering innovations in ophthalmology … … with NCX 470 the next derisked asset advancing toward NDA filing in the U.S. and China Commercial value of lead Global partnerships with asset NCX 470 in late- Deep ophthalmology Tier 1 ophthalmology NICOX visible science stage Phase 3 experie
Slide 5: Upcoming milestones
Upcoming milestones Several positive milestones in 2024 and 2025 NCX 470 ZERVIATE Corporate NICOX visible science v Completion of recruitment of v Upcoming approval in China v AGM for the approval of the U.S. patients Q4 2024 v Estimated Chinese sales up to 2023 accounts v Denali results – H2 2025 $
Slide 6: An innovative portfolio led by NCX 470, a derisked product candidate
An innovative portfolio led by NCX 470, a derisked product candidate with global potential Stages of Development 3 Product Candidates Preclinical Phase 1 Phase 2 Phase 3 NDA Marketed Expected Milestones Denali topline results in H2 2025 NCX 470 | NO-donating bimatoprost eye drops Whistler Phase 3 re
Slide 7: Glaucoma: a worldwide ophthalmic condition with unmet medical needs
Glaucoma: a worldwide ophthalmic condition with unmet medical needs Elevated IOP* contributes to irreversible optic nerve damage, leading to progressive vision loss NICOX visible science As published in the landmark EMGT study “…each mmHg of decreased IOP was related to an approximately 10% lowering
Slide 8: Unmet medical needs for glaucoma treatment
Unmet medical needs for glaucoma treatment 40% of patients Many patients Tolerability issues Despite having well established do not achieve require >1 with some NICOX visible science first-line therapies, including the their target IOP medication which medications lead standard-of-care, latanoprost,
Slide 9: NCX acts through a dual mechanism for IOP lowering
NCX 470 acts through a dual mechanism1 for IOP lowering Non-clinical optic nerve/retinal damage models also demonstrate potentially beneficial retinal effects2 Two pathways for aqueous humor outflow 1 Primary or conventional outflow normally Stimulated by NICOX visible science accounts for ~60% to n
Slide 10: Positive NCX Mont Blanc topline results
Positive NCX 470 Mont Blanc topline results1,2,3 Phase 3 clinical program intended to support planned U.S. & China NDA submissions Designed to demonstrate safety and efficacy of NCX 470 0.1% vs. latanoprost 0.005%, defined by IOP reduction from time-matched baseline at pre-established time points NI
Slide 11: Mont Blanc Phase 3 efficacy trial design
Mont Blanc Phase 3 efficacy trial design1 Designed to evaluate NCX 470 vs. established therapy, latanoprost Randomized, controlled, double-masked, parallel design trial. Patients with open angle glaucoma or ocular hypertension were randomized 1:1 to once-daily treatment with NCX 470 0.1% or latanopr
Slide 12: Baseline characteristics, demographics and disposition
Baseline characteristics, demographics and disposition1 NCX 470 0.1% Latanoprost 0.005% N = 328 N = 333 Mean Diurnal Baseline (8am+4pm) IOP, mmHg, Study Eye (SD) 26.9 (2.04) 26.8 (2.02) Gender, n (%) Female 200 ( 61.0%) 188 ( 56.5%) Male 128 ( 39.0%) 145 ( 43.5%) NICOX visible science Age, Years (SD
Slide 13: Significant, sustained IOP-lowering effects
Significant, sustained IOP-lowering effects IOP-lowering from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost NCX 470 0.1%: N = 328 Latanoprost 0.005%: N = 333 NICOX visible science • Denotes statistically significant differences vs latanoprost (p<0.049) 13 • Fechtner et
Slide 14: NCX 470 0.1% achieved non-inferiority vs latanoprost
NCX 470 0.1% achieved non-inferiority and demonstrated an IOP- lowering greater than Latanoprost 0.005% of up to 1.0mmHg To be non-inferior, the treatment difference between NCX 470 and latanoprost had NICOX visible science to meet BOTH criteria: • For all 6 timepoints, the upper limit of all confid
Slide 15: NCX topline results demonstrate robust efficacy and safety
NCX 470 topline results demonstrate robust efficacy and safety1 All comparisons are based on NCX 470 0.1% and latanoprost 0.005% Topline results from this pivotal trial: • IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs. 7.1 to 9.4 mmHg for latanoprost • Statistical non-inferior
Slide 16: NCX presentations at key ophthalmology conferences
NCX 470 – Presentations at key ophthalmology conferences • Poster 1: Intraocular Pressure Reduction with NCX 470 versus Latanoprost Across the Spectrum of Baseline Intraocular Pressures • Poster 2: Intraocular Pressure Reduction with NCX 470 versus Latanoprost In Previously Treated Versus Treatment-
Slide 17: U.S. glaucoma clinical advisory board with leading experts
U.S. glaucoma clinical advisory board with leading experts DR. ROBERT D. FECHTNER, MD, CHAIRMAN DR. STEVEN MANSBERGER, MD MPH Professor and Chair of the Department of Ophthalmology Vice-Chair, Senior Scientist, and Director of Glaucoma Services and at SUNY Upstate Medical University, Syracuse, NY Op
Slide 18: Value proposition of NCX 470
Value proposition of Novel molecule with competitive positive impact on lowering intraocular pressure (IOP), the leading NCX 470 cause of glaucoma Positive pivotal Phase 3 topline results from the Mont Blanc trial 1,2,3 First non-combination product to demonstrate NICOX visible science statistical n
Slide 19: NCX 470 Commercial Potential and Timing
NCX 470 Commercial Potential and Timing A near-term asset arriving at completion of development H2 2025 H1 2026 H1 2027 NICOX visible science Topline results of Submission of New Approval and Denali Phase 3 Drug Application in potential launch in Clinical Trial the United States* the United States**
Slide 20: Ocumension: Chinese partner and largest Nicox shareholder
Chinese partner and largest Nicox shareholder, dedicated to ophthalmology with manufacturing and commercial capabilities NICOX visible science Portfolio of 25 Listed on the products with 444 employees, Based in China Hong Kong stock including 232 in Created in 2018 10 commercialised exchange since c
Slide 21: Kowa: global enterprise with Japanese glaucoma franchise
Global enterprise with a strong pharmaceutical business and Japanese glaucoma franchise NICOX visible science Founded in Japan in 1894 ~8000 employees The pharmaceutical Team of medical Active worldwide with an annual sector is an representatives in in multiple group revenue of important one with Ja
Slide 22: Future commercialization of NCX 470
Future commercialization of NCX 470 To secure the long-term future of the Company • The Company is considering a number of options to ensure the commercialization of NCX 470 and concretize the future strategy: NICOX visible science • New license agreements • Joint venture structures with companies h
Slide 23: Existing commercial products
Existing commercial products VYZULTA Nicox receives 6% net1 royalties on global sales – VYZULTA sales increased 35% in 2023 vs. 2022 NICOX visible science $5 million net milestone payable to Nicox at $100 million net sales Marketed in >15 countries and territories, including the U.S. Patent extended
Slide 24: A refocused global leadership team
A refocused global leadership team NICOX visible science Gavin Spencer Sandrine Gestin Doug Hubatsch Chief Executive Officer VP, Finance and HR EVP, Chief Scientific Officer Sonia Benhamida Observer BlackRock Damian Marron Michele Garufi Marc Le Bozec Gavin Spencer Maurizio Petitbon Chairman of the
Slide 25: Financial highlights
Financial highlights Cash balance expected to support current operations through end of February 2025 Financial Position and Ownership of the Nicox Group1 Cash, Cash Equivalents as at 31 March 2024 €12.4 million2 NICOX visible science Long term debt2 as at 31 March 20243 €20.5 million Cash runway4 F
Slide 26: Investment highlights
Investment highlights ü A proven track record in clinical development and business development • Two product approvals in the U.S., one pending in China • Business development deals in the U.S., Japan, China, and globally with Tier 1 companies NICOX visible science ü NCX 470, a derisked, late-stage
Slide 27: Nicox S.A. contact
Nicox S.A. Sundesk Sophia Antipolis Emerald Square Bâtiment C communications@nicox.com rue Evariste Galois, 06410 Biot, France www.nicox.com T: +33 (0)4 97 24 53 00 27