Nicox Sa · EURONEXT:ALCOX
Nicox Sa — Investor Presentation (September 2024)
28 slides from Nicox Sa's investor presentation, Sep 4, 2024
Slide 1: Nicox Corporate Presentation
Nicox Corporate Presentation An international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health September 4, 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 ✔ Restructuring of debt agreements with BlackRock NICOX visible science ✔ Streamlining costs to concentra
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 asset Global partnerships with Deep ophthalmology NCX 470 in late-stage Phase 3 NICOX visible science Tier 1 ophthalmology players
Slide 5: Upcoming milestones
Upcoming milestones Several positive milestones in 2024 and 2025 NCX 470 ZERVIATE Corporate NICOX visible science ❖ Upcoming approval in China ❖ Ongoing business development ❖ Denali results – H2 2025 ❖ Estimated Chinese sales up to discussions ❖ Estimated worldwide sales over $100 million2 $300 mil
Slide 6: An innovative portfolio led by NCX 470
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 Status Denali topline results expected in NCX 470 | NO-donating bimatoprost eye drops H2 2025 Glaucoma & Ocular Hyper
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 do ✔ Many patients ✔ Tolerability issues Despite having well established not achieve their require >1 with some NICOX visible science first-line therapies, including the target IOP on medication which medications lead standard-of-care, lat
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 Primary or conventional humor outflow 1 outflow normally accounts Stimulated by NICOX visible science for ~60% to 8
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 N
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 to 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 to meet BOTH NICOX visible science criteria: • For all 6 timepoints, the upper limit of all confide
Slide 15: NCX 470 topline results demonstrate robust efficacy and safety
NCX 470 topline results demonstrate robust efficacy and safety 1 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-inferio
Slide 16: NCX 470 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: Mont Blanc results published in a prestigious journal
Mont Blanc results published in a prestigious journal NICOX visible science Conclusion: The NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with OAG or OHT at all 6 time points. With a dual mechanism of action that enhances both uv
Slide 18: 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 at Vice-Chair, Senior Scientist, and Director of Glaucoma Services and SUNY Upstate Medical University, Syracuse, NY Op
Slide 19: Value proposition of NCX 470
Value proposition of ✔ Novel molecule with competitive positive impact on lowering intraocular pressure (IOP), the leading cause of NCX 470 glaucoma ✔ Positive pivotal Phase 3 topline results from the Mont Blanc trial1,2,3 ✔ First non-combination product to demonstrate statistical NICOX visible scie
Slide 20: 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 21: Chinese partner Ocumension Therapeutics
Chinese partner and largest Nicox shareholder, dedicated to ophthalmology with manufacturing and commercial capabilities NICOX visible science Portfolio of 25 Listed on the 444 employees, Based in China products with Hong Kong stock 10 commercialised including 232 in Created in 2018 exchange since $
Slide 22: Japanese partner Kowa
Global enterprise with a strong pharmaceutical business and Japanese glaucoma franchise Founded in Japan NICOX visible science 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 23: 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 24: Existing commercial products
Existing commercial products VYZULTA ✔ Nicox receives 6% net1 royalties on global sales – VYZULTA sales increased 35% in 2023 vs. 2022 ✔ $5 million net milestone payable to Nicox at $100 million net sales NICOX visible science Marketed in >15 countries and territories, including the U.S. ✔ Patent ex
Slide 25: A refocused global leadership team
A refocused global leadership team Gavin Spencer Sandrine Gestin Doug Hubatsch NICOX visible science Chief Executive Officer VP, Finance and HR EVP, Chief Scientific Officer Sonia Benhamida Observer BlackRock Damian Marron Christine Placet Marc Le Bozec Gavin Spencer Maurizio Petitbon Chairman of th
Slide 26: Financial highlights
Financial highlights Cash balance expected to support current operations through to February 2025 Financial Position and Ownership of the Nicox Group1 Cash, Cash Equivalents as at 30 June 2024 €7.8 million NICOX visible science Long term debt as at 30 June 20242 €20.5 million Cash runway3 February 2
Slide 27: Investment highlights
Investment highlights ✓ 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 ✓ NCX 470, a derisked, late-stage
Slide 28: Nicox S.A. contact details
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 28