Nyxoah SA · EURONEXT:NYXH
Nyxoah SA — Investor Presentation (January 2022)
18 slides from Nyxoah SA's investor presentation, January 2022
Slide 1: Nyxoah
Nyxoah January 2022
Slide 2: Forward-Looking Statements
Forward-Looking Statements Please read the following before continuing. This presentation has been prepared by the management of Nyxoah SA (the "Company"). It does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or oth
Slide 3: Experienced Board And Management Team
Experienced Board And Management Team Robert Taub Olivier Taelman Loïc Moreau Founder, Chairman CEO CFO • Serial entrepreneur in the pharmaceutical and • Experienced Medtech leader • Experienced Finance leader medical fields • 7 years in pharmaceutical healthcare at Eli Lilly and • 13 years in Pharm
Slide 4: Experienced Management Team
Experienced Management Team Bruno Onkelinx An Moonen Jey Subbaroyan Nathalie Gilat CTO General Counsel VP Clinical Affairs VP RA – GM Israel • Has 25 years of experience in highly regulated • Joined Nyxoah in December 2020 as General • Hs 14 years of experience in clinical and pre- • Has over 14 yea
Slide 5: Large and Underpenetrated Global OSA and HGNS Market Opportunity
Large and Underpenetrated Global OSA and HGNS Market Opportunity Worldwide Obstructive Sleep Apnea Prevalence Hypoglossal Nerve Stimulation Market Opportunity 936 Million >1 million eligible annually in key geographies • 936M individuals (30-69 year) are estimated to suffer from OSA1 • US: 510,000 e
Slide 6: Our Vision: Improving Lives through Restful Nights
Our Vision: Improving Lives through Restful Nights • A disruptive patient-centered solution TODAY… … An intelligent MedTech solution TOMORROW Single incision procedure Leadless and battery-free Full-body 1.5T and 3T MRI compatible Bilateral stimulation CCC FDA breakthrough designation CCC indication
Slide 7: Genio® Dimensions
Genio® Dimensions Genio® Implantable Stimulator 27.5 mm 21.3 mm Weight 2,96 grams 21.5 mm Genio® Activation Chip 31.7 mm Weight 20.6 mm 12 grams 27 mm 7
Slide 8: The Genio® System – Addressing Unmet Physician Needs
The Genio® System – Addressing Unmet Physician Needs Physician Single procedure • Extended operative time is associated with increased risk of surgical site infection13 Implantable parts 1 – Genio® IS 3 – Pulse generator + 2 leads 2 – Pulse generator + lead Leadless Number of incisions 1 incision At
Slide 9: The Genio® System – Addressing Unmet Patient Needs
The Genio® System – Addressing Unmet Patient Needs Patient User-centric • No bulky pulse generator under the skin / Only one discreet scar in the chin fold Indicated for CCC and non-CCC patients Number of scars 1 – in the chin fold At least 2 scars 2 scars • CCC prevalence is superior to 35% in OSA
Slide 10: 2021 Key Achievements – Execution Focus
2021 Key Achievements – Execution Focus Jan • MR Conditional Labeling – 1.5T & 3T / Full-Body • VANDERBILT University Exclusive Licensing (Ansa Feb Cervicalis) • BETTER SLEEP study 6 months Safety and Performance May Endpoints – CCC Therapy Indication Expansion • Germany Commercial Proof of Concept
Slide 11: Clinical Strategy – Building Robust Clinical Evidence
Clinical Strategy – Building Robust Clinical Evidence CE-Mark BLAST OSA – 27 patients • 2 publications • CE mark approval in 2019 Demonstrate long-term safety and efficacy EliSA – At least 110 patients • 20 EU centers in 5 countries Enrolment completed by end 2022 • 5-year follow-up Expand Genio® th
Slide 12: DREAM trial – IDE Pivotal Trial
DREAM trial – IDE Pivotal Trial Failed, Combined central/mixed AHI>25% total AHI Population and key 22 < Age < 75 Failed, did Notnot tolerate Tolerated or or refused Refused PAPPAP inclusion criteria excluded BMI ≤ 32 kg/m2 Moderate Moderate to severe OSA––AHI Severe OSA AHI15-65 15-65 CCC of soft p
Slide 13: DREAM Study – US Active Sites
DREAM Study – US Active Sites Principal Investigator Institution & Location Kirk P. Withrow MD UAB, Birmingham, AL Samuel Mickelson MD, FACS Advanced ENT, Atlanta, GA Colin Huntley MD & Maurits S. Boon MD Thomas Jefferson Philadelphia, PA Tapan A. Padhya MD USF, Tampa General MC, Tampa, FL Marion Bo
Slide 14: DREAM IDE Trial – Status Update (Week 3 January 2022)
DREAM IDE Trial – Status Update (Week 3 January 2022) Enrolled consent 321 Failed screening Active screening OR scheduled / Implanted 161 123 37 • Status • Patient drop out (54%) from Enrolled to Implant driven by DISE, PSG, BMI • Projected implants completion by end Q1 2022 • US commercialization e
Slide 15: Commercial Leadership Through Focused Execution
Commercial Leadership Through Focused Execution Go Deep versus Go Wide EU Market Access Germany - Proof of concept Nyxoah – EU reimbursed countries GERMANY – 13 headcounts • Germany – 2021: Dedicated DRG code NORTH • 2021: 2 CoEs • 2022: 3 new accounts • Switzerland – 2021: Dedicated DRG code • Spai
Slide 16: High Quality and Diverse International Shareholder Base
High Quality and Diverse International Shareholder Base Euronext IPO Current Shareholder Base • September 2020 • Robert Taub Historical Shareholders • Base offering & over-allotment: €85M ($100M) • Together Partnership • Jürgen Hambrecht International strategics US Institutional Nasdaq IPO • July 20
Slide 17: Strong Cash Position Supports Clinical and Commercial Priorities in 2022 and Beyond
Strong Cash Position Supports Clinical and Commercial Priorities in 2022 and Beyond Strong Cash Position Operating Expense Growth (in €) +20% • Operating expenses to increase by ~19% in 2022 • R&D/Clinical to represent 2/3 of +15% 2022 expenses driven by DREAM June 2021, cash position €79M enrollmen
Slide 18: Thank you Q&A
Thank you Q&A www.nyxoah.com All rights reserved © 2021 Nyxoah SA. All content on this presentation, including the texts, trademarks, service marks, logos, illustrations, photos, graphics, design etc., are the property of Nyxoah SA. Nyxoah SA owns all rights with respect to any of their trademarks,