Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Second Sight Medical Products — Merger or Acquisition (January 2021)
36 slides from Vivani Medical's merger presentation, Jan 6, 2021
Slide 1: Pixium Vision / Second Sight Medical Products Business Combination
Pixium Vision / Second Sight Medical Products Business Combination January 6th 2021 Exhibit 99.2
Slide 2: Legal Disclaimer
Legal Disclaimer Additional Information and Where to Find It In connection with the proposed transaction between Second Sight Medical Products, Inc. (“Second Sight”) and Pixium Vision, Second Sight will file with the United States Securities and Exchange Commission (the “SEC”) preliminary and defini
Slide 3: Speakers on this Call
Speakers on this Call Lloyd Diamond – CEO of Pixium Vision 25+ years experience in the MedTech industry Extensive experience in development, commercial and financing in orthopedic, ophthalmology and other clinical segments Dr. José-Alain Sahel – Distinguished Professor and Chair of the Department of
Slide 4: Contemplated Combination
Second Sight Medical Products develops, manufactures, and markets implantable visual prosthetics to provide artificial vision to blind individuals seeking greater independence Contemplated Combination Pixium aims to create a world of bionic vision for those who have lost their sight, enabling them t
Slide 5: Combination Offers Synergies
One product company with limited organizational synergies One product company with limited organizational synergies Becoming a global leader, multiple product ophthalmology company with strong organizational synergies Aiming to treat Dry Age Related Macula Degeneration (AMD) Aiming to treat glaucoma
Slide 6: Structure and Timing of the Business Combination
Structure and Timing of the Business Combination Euronext Growth Listed ~ 60% on pre-financing basis Transfer of all assets and liabilities related to neuromodulation technology used in the treatment of blindness Current Second Sight shareholders ~ 40% Orion Assets ~ 60% ~ $25m fund raising Business
Slide 7: Pixium Vision
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Slide 8: Pixium Vision Company Overview: Investing Into the Last Stage of Clinical Development
Pixium Vision Company Overview: Investing Into the Last Stage of Clinical Development Focus: Neuromodulation in ophthalmology Brain-machine technology company leveraging proprietary algorithms and artificial intelligence to develop bionic vision system for the treatment of retinal dystrophies Develo
Slide 9: Pixium Vision Enters its Next Phase
2019 2011 – 2019 First generation retinal implant for Retinitis Pigmentosa released to market Validated through several iterations of implants and image processing systems Sub-retinal implant manufacturing process to meet commercial demand Generated data in five patients Foundations Set in Place 201
Slide 10: Addressing a Large Unmet Need in Dry-AMD
Addressing a Large Unmet Need in Dry-AMD, Which Affects 80-90% of AMD Patients The Well Served Wet-AMD Market Vs. the Underserved Dry-AMD Market (1) Trans Am Ophthalmol Soc. 2005 Dec; 103: 173–186 (2) Based on 2018 Global sales: Lucentis (Roche/Novartis) $3.7B and Eylea (Bayer/Regeneron) $6.7B Age-r
Slide 11: Progressive Loss of Visual Acuity in AMD Patients Leads to Dramatic Loss in Quality of Life
Progressive Loss of Visual Acuity in AMD Patients Leads to Dramatic Loss in Quality of Life Trans Am Ophthalmol Soc. 2005 Dec; 103: 173–186 DALY: Disability-Adjusted Life Year: DALYs sum years of life lost (YLL) due to premature mortality and years lived in disability/disease (YLD) LogMar 0.8 LogMar
Slide 12: Prima System Pricing Expected Well Below Commonly Accepted Efficacy Based Pricing
Prima System Pricing Expected Well Below Commonly Accepted Efficacy Based Pricing Usually accepted US$150,000 per QALYUsually accepted €50,000 per QALY Prima System Planned US$75,000 pricing QALY = 1.5-2.5(1) (1) Company expectations based on clinical data generated to date QALY: Quality-Adjusted Li
Slide 13: Initially Targeting 15,000 U.S. & Europe Dry-AMD Patients
Initially Targeting 15,000 U.S. & Europe Dry-AMD Patients, with Potential to Address 120,000 Assumes Prima system planned price of US$75,000 Atrophic Dry-AMD (GA) 1.5-3.8m Late stage (VA 20/400 and below) 350,000-500,000 Almost no foveal perception 170,000 Addressable patient population 120,000 US$9
Slide 14: Focusing on All Treating Referral Centers to Most Efficiently Target Patients
Focusing on All Treating Referral Centers to Most Efficiently Target Patients in Need Top 20 retinal centers Treat ~60% patients 15 EU retinal centers Treat ~55% patients 120,000 patients treated 50%50% 36,000 patients 33,000 patients Br J Ophthalmol. 2018 Oct;102(10):1391-1395. doi: 10.1136/bjophth
Slide 15: Pixium's Prima System Initial Market Potential
Pixium’s Prima System Initial Market Potential Prima System could generate over US$400m in annual revenues based on the following assumptions 20% market penetration in patients with established dry-AMD 7-years post launch 30% market penetration in newly diagnosed patients 7-years post launch Key dri
Slide 16: Prima System: Breakthrough Machine-brain Interface for Dry-AMD
Prima System: Breakthrough Machine-brain Interface for Dry-AMD
Slide 17: Prima System, a Cutting-Edge Technology Supported by Multi-disciplinary Partners
Universities and Research Institutes Vision Clinics Prima System, a Cutting-Edge Technology Supported by Multi-disciplinary Partners
Slide 18: The Prima System Components
Partially replaces the normal physiological function of the eye’s photoreceptor cells The Prima System is composed of three main elements: Wireless retinal implant Pair of glasses with a camera and digital projector Pocket processor Electrically stimulates the nerve cells of the inner retina Transmi
Slide 19: Prima System – 3 Step Visualization Process
Mini-camera captures images of the environment as a video stream and send it to pocket computer Pocket computer transforms the images into stimulation signals using proprietary algorithms and send back signals to glasses Prima System – 3 Step Visualization Process Step 1 Generating Signal based on s
Slide 20: Clinical Development
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Slide 21: Clinical Data Show Extreme Improvement at 18 Months
Prima 1 data generated with 1st generation Visual Processor Baseline No central vision 5/5 patients Letters, Words and Sentences As small as Font 18 3/5 patients PRIMA (Font 18) P R I M A (Font 8) Up to 7 lines of improvement means ability to read street signs Prima 2 Data in Q1 2020 with 2nd genera
Slide 22: EU & U.S. Clinical Development Overview
2018 2020 2021 2022 2023 2019 2023+ EU & U.S. Clinical Development Overview 12-month follow-up CE mark submission CE mark France First-in-Human Study PRIMAVERA Pivotal Study PRIMAVERA accepted in the U.S. Prima 2 data 12-month follow-up Early Feasibility Study Potential earlier U.S. approval Expecte
Slide 23: Conclusion
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Slide 24: Pixium Vision Equity Story
Pixium Vision Equity Story Supported by top-tier KOL group 8 TAM of $9 Bn expected to facilitate >$400M peak sales with conservative adoption assumptions 7 Accelerated clinical pathway for U.S. and European market approvals 4 Favorable reimbursement landscape suggests ASP of $75,000 per patient 6 Po
Slide 25: Second Sight Medical Products
Second Sight Medical Products
Slide 26: Orion Visual Cortical Prosthesis
Orion® Visual Cortical Prosthesis 2019 Aims to treat glaucoma, diabetic retinopathy, optic nerve disease, and eye trauma Six subject feasibility study at UCLA and Baylor has positive results that support advancement Leverages Argus® II technology including: Implantable array External and proprietary
Slide 27: Orion Interim Study Results Support Advancement to Pivotal
Orion® Interim Study Results Support Advancement to Pivotal 2019 Initial results from first six subjects at 12 months Safety Square Localization (SL) Direction of Motion (DOM) FLORA 1 SAE (seizure) 6 AEs (2 subjects, 4* subjects with no AEs) 5 of 6 Perform Better with Orion® System ON versus OFF 6 o
Slide 28: Orion Addressable Market and U.S. Reimbursement Strategy
Orion® Addressable Market and U.S. Reimbursement Strategy Initial target populations in U.S. represents a $1 bn plus market opportunity(1) (1) Assumes an average selling price of $250k per device (2) Based on company estimates and 3rd party market research Markets outside U.S. expected to be larger
Slide 29: Thank you
Thank you Lloyd Diamond, CEO | ldiamond@pixium-vision.com
Slide 30: Appendix A: Business Combination Rationale
Appendix A: Business Combination Rationale
Slide 31: Additional Combination Rationale
Fully integrated company Fully integrated company Economies of scale R&D, G&A, manufacturing Industrial capabilities already validated Limited manufacturing capabilities Optimizing manufacturing capabilities Strong EU network of ophthalmologists and reference centers Strong U.S. network of ophthalmo
Slide 32: Additional Combination Rationale (Continued)
Limited Market Cap and trading volume EU located Limited market cap and trading volume despite U.S. located Larger market cap higher trading volume driving capital flexibility Investors EU focused Investors U.S. focused Synergistic investor relations from both geographic and market cap perspectives
Slide 33: Appendix B: Additional Prima Information
Appendix B: Additional Prima Information
Slide 34: The Role of the Retina and How Eye Disease Leads to Progressive Loss of Central Vision
The Role of the Retina and How Eye Disease Leads to Progressive Loss of Central Vision
Slide 35: Prima System – Machine-Brain Interface Technology Using Artificial Intelligence
Prima System – Machine-Brain Interface Technology Using Artificial Intelligence
Slide 36: With the Prima System, the Signal to the Brain is Restored
With the Prima System, the Signal to the Brain is Restored
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