Picard Medical, Inc. · AMEX:PMI
Picard Medical — SPAC Merger (April 2023)
29 slides from Picard Medical's SPAC merger presentation, Apr 24, 2023
Slide 1: Total Artificial Heart, Viable Alternative to Heart Transplants
Exhibit 99.2 Confidential SynCardia, a subsidiary of Picard Medical Total Artificial Heart, Viable Alternative to Heart Transplants 24 April 2023 Preliminary |
Slide 2: Disclaimer (1/2)
Disclaimer (1/2) THIS PRESENTATION (TOGETHER WITH ORAL STATEMENTS MADE IN CONNECTION HEREWITH, THIS “PRESENTATION”) IS BEING PROVIDED TO YOU SOLELY FOR YOUR INFORMATION. THIS PRESENTATION HAS NOT BEEN APPROVED BY ANY REGULATORY AUTHORITY. THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER TO SELL OR ISS
Slide 3: Disclaimer (2/2)
Disclaimer (2/2) Industry and Market Data In this Presentation, we rely on and refer to information and statistics regarding market participants in the sectors in which the Company competes and other industry data. We obtained this information and statistics from third-party sources, including repor
Slide 4: Risk Factors
Risk Factors The risks presented below are certain of the general risks related to the Company, SynCardia, Altitude, and the proposed business combination among the Company, Altitude and their respective subsidiaries, as applicable (the “Business Combination”), and such list is not exhaustive. You s
Slide 5: Risk Factors: Risks Related to Our Business (Continued)
Risk Factors Risks Related to Our Business (Continued) • We are subject to credit risk from our accounts receivable related to its product sales, which include sales within foreign countries that have recently experienced economic turmoil. • We are subject to risks associated with currency fluctuati
Slide 6: Risk Factors: Risks Related to Intellectual Property
Risk Factors Risks Related to Intellectual Property • Many aspects of the SynCardia TAH are no longer protected by patents, and we may be unable to protect our products from competition through other means. • The medical device industry is characterized by extensive patent litigation, and we could b
Slide 7: Risk Factors: Risks Related to the Combined Company's Securities
Risk Factors Risks Related the Combined Company’s Securities Following Consummation of the Business Combination • The requirements of being a public company may strain our resources, divert management’s attention, and affect our ability to attract and retain executive management and qualified board
Slide 8: Picard Management
Picard Management Richard G. Smith, MSEE, CCE Richard Fang, PhD Co-founder & Chief Science Officer Board Member & CEO ▪ Managing Partner of Hunniwell Lake Ventures▪ 45 years in biomedical engineering; 35 years with circulatory support devices ▪ Former CEO of Reach Surgical ▪ Former Director of the A
Slide 9: Altitude Management
Altitude Management Gary Teplis Founder, President, CEO & Director of Altitude Acquisition Corp. ▪ CEO of Teplis Travel ▪ Avid public equity, private equity and angel investor ▪ Lead investor in Travelscape.com ▪ Lead investor in the development of Under Armour’s global corporate headquarters ▪ Roll
Slide 10: Transaction Summary
Transaction Summary • Picard Medical and its Subsidiary, SynCardia Systems, a Pioneer in Total Artificial Heart Technology, to Become a Publicly Traded Company • Transaction Value ▪ Expected $480.0M Pre-Money Enterprise Value – Closing consideration consists of 48M shares of common stock and 6.5M wa
Slide 11: Sensitivity Analysis: Sources and Uses, Pro-Forma Capitalization
Sensitivity Analysis Sources and Uses Shares Out Sources Uses Illustrative Pro-Forma Capitalization Table (mm) (%) Picard Medical Inc. roll-over $ 480.0 Picard Medical Inc. roll-over $ 480.0 Existing Picard Medical Inc. Shareholders (1) 49.300 87.7% Permitted Company Financing (4) $ 20.0 Estimated t
Slide 12: SynCardia at-a-Glance
SynCardia at-a-Glance ▪ SynCardia’s Total Artificial Heart (TAH) replaces full functions of a failing or failed human heart ▪ Designed to address unmet and growing needs in multibillion-dollar markets in the U.S. and globally ▪ Approved for use in over 30 countries, including the U.S., Canada, UK, a
Slide 13: Cardiovascular Diseases are the Leading Cause of Death Globally
Cardiovascular Diseases are the Leading Cause of Death Globally Growing heart failure in the U.S. Heart Failures (million cases) 3 >8.0 6.2 5.7 64.3M 6.2M Worldwide U.S. 2012 2018 2030 1 in every 5 deaths Annual Costs to the U.S. are related to heart failure in the U.S. 379,800 $30.7B 1 2 Deaths Cos
Slide 14: Substantial Demand-Supply Imbalance Driving Urgent Need for TAH
Substantial Demand-Supply Imbalance Driving Urgent Need for TAH 300,000+ 100-to-1 heart transplant U.S. patients (per year) imbalance in the U.S. end-stage heart failures 5% are end-stage heart failure patients Limited heart transplantations in the U.S. 3,000 – 4,000 4,000 heart transplantations eac
Slide 15: Our Solution: The First and Only Commercially-Available Total Artificial Heart
1 Our Solution: The First and Only Commercially-Available Total Artificial Heart (TAH) in the U.S. Replacement to full functions of a human heart for end-stage, biventricular heart failure Obtained approvals from: U.S. Canada Source: SynCardia Confidential 1 15 Note: Based on company’s review of pub
Slide 16: Founded by Well-known Cardiologists and Surgeons, SynCardia Achieved Significant Success
Founded by Well-known Cardiologists and Surgeons, SynCardia Achieved Significant Success Since Jack G. Copeland, MD 750 years 2,000+ Former President, the International Society of Heart and devices implanted clinical use Lung Transplantation; Cardiothoracic surgeon 32 140+ Marvin J. Slepian, MD coun
Slide 17: Strong Clinical Results and Proven Efficacy
Strong Clinical Results and Proven Efficacy 79% Survival rate to transplantation (vs. 46% in control group) 70% Survival rate at 1-year (vs. 31% in control group) Over 60% Patients survived over 2 years or successfully transplanted Just over 6 years Longest living patient on SynCardia TAH Source: Th
Slide 18: Prolonging and Enabling High-Quality Lives
Prolonging and Enabling High-Quality Lives Jahiem, 11, supported by Stan, 23, played basketball wearing SynCardia TAH for 280 days Freedom® Portable Driver in the backpack Mohamad, 27, the first TAH transplant in Lebanon Randy, 39, completed the 4.2-mile Pat’s Run event Bob, 55, went on hunting trip
Slide 19: Capturing the Growing Opportunity
Capturing the Growing Opportunity Confidential 19 19
Slide 20: Igniting Growth Drivers
Igniting Growth Drivers Growth Drivers 1 ▪ FDA Long-term Indication expands current end market size from 6,000 – 7,000 patients a Obtaining FDA year (on transplant waitlist) to over 300,000 patients a year Long-term ▪ Encourages cardiologists and surgeons to recommend TAH to their patients Indicatio
Slide 21: SynCardia is Expecting the Long-Term Indication Approval From U.S. FDA
1 SynCardia is Expecting the Long-Term Indication * Approval From U.S. FDA Larger Sample Size and Better Results Provide Strong Support for Our Application Long-term Indication Approval ▪ Left ventricular heart assist devices (LVAD) underwent similar application pathway and obtained its Destination
Slide 22: Multi-Billion Dollar Market Opportunity in the U.S.
1 Multi-Billion Dollar Market Opportunity in the U.S. Long- FDA B BT TT T Designations Term U.S. Patient >300,000 6,000+ Population Market ~$30B $1B Opportunity (TAM) Source: L.E.K. Research and Analysis, SynCardia Confidential 22 22
Slide 23: Strong R&D and Commercial Pipeline Fueling Further Growth
2 Strong R&D and Commercial Pipeline Fueling Further Growth Freedom Driver (UPGRADE) TAH Plus (UPGRADE) ▪ To improve patient experience and product servicing▪ Upgraded existing implant components ▪ Extend maintenance cycle from 60-90 days to 1-year▪ Improved driver lines (polyurethane or other bio-
Slide 24: Major Product and Upgrade Goals and Milestones
2 Major Product and Upgrade Goals and Milestones 2023 2024 2025 ▪ Commercial launch of ▪ Launch of C2 Plus, upgraded ▪ Full commercial launch of Freedom I Series Driver hospital driver unit Freedom II driver unit upgrades, including Software, ▪ Launch of TAH Plus, Hardware and Hush upgraded implanta
Slide 25: Substantial and Growing Global Market Opportunity
3 Substantial and Growing Global Market Opportunity CANADA Population: 38M EUROPE 7 Heart failures: 0.8M Population: 746M JAPAN 6 Heart failures: >15M Population: 126M 1 Heart failures: 979K MIDDLE EAST Population: 411M 5 CHINA Heart failures: 3.75M Population: 1.4B 2 Heart failures: 4.5M INDIA Popu
Slide 26: Significant Progress in Global Market Expansion
3 Significant Progress in Global Market Expansion ▪ Establishing a joint venture with a local partner in 1H 2023 ▪ Local partner hiring personnel specialized in clinical trials and regulatory approval ▪ Preparing for regulatory application submission to China MNPA and expect to obtain approval CHINA
Slide 27: SynCardia is Ahead of the Competition
SynCardia is Ahead of the Competition… Company Not available; R&D and The Only TAH approved for Obtained CE Marking for Status Commercial use by US FDA and Commercial Use in Europe animal trials Health Canada ▪ 2004 (BTT) None None US ▪ Applying for L-term Indication Approval 1999 (CE to be reinstat
Slide 28: Business Summary
Business Summary ▪ First and the only TAH option in the U.S. The only commercially-available ▪ Approved by U.S. FDA and Canada Health Total Artificial Heart ▪ Available in 140 hospitals all over the world ▪ Achieved favorable clinical data with 79% survival rate to transplantation and 70% one-year p
Slide 29: Business Summary
Business Summary ▪ First and the only TAH option in the U.S. The only commercially-available ▪ Approved by U.S. FDA and Canada Health Total Artificial Heart ▪ Available in 140 hospitals all over the world ▪ Achieved favorable clinical data with 79% survival rate to transplantation and 70% one-year p