Pavmed Inc. · NASDAQ:PAVM
Pavmed — IPO Roadshow (April 2016)
38 slides from Pavmed's IPO roadshow presentation, Apr 1, 2016
Slide 1: Lishan Aklog, MD Chairman & CEO
1 LISHAN AKLOG, MD Chairman & CEO March 31, 2016 TM
Slide 2: Disclaimer
2 Disclaimer PAVMED INC. (“PAVMED”) HAS FILED A REGISTRATION STATEMENT (INCLU DING A PROSPECTUS) WITH THE SEC FOR THE OFFERING TO WHICH THIS COMMUNICATION RELATES. BEFORE YOU INVEST, YOU SHOULD READ THE PROSPECTUS IN THAT REGIST RATION STATEMENT AND OTHER DOCUMENTS PAVMED HAS FILED WITH THE SEC FOR
Slide 3: Company Overview
3 Company Overview
Slide 4: Innovative multi-product medical device company
4 Innovative multi - product medical device company • Rapid speed to market • Highly capital efficient Unique, proven business model • 4 successful single - product companies • 3 products commercialized, 1 products at FDA • 1 company sold for $55M+ to a Nasdaq - listed company Leadership team with s
Slide 5: Leadership team with strong record of value creation
5 LISHAN AKLOG, MD C HAIRMAN & CEO ▪ A.B. Physics, magna cum laude ▪ Phi Beta Kappa ▪ M.D., cum laude ▪ General Surgery Resident ▪ Cardiothoracic Surgery Resident ▪ Assistant Professor ▪ Associate Surgeon ▪ Associate Chief of Cardiac Surgery ▪ Assistant Professor ▪ Director of Minimally Invasive Car
Slide 6: Leadership team's prior track record of success
6 Leadership team’s prior track record of success A NGIO V AC ® Endovascular device to remove large clots and other material V ENO P AX ® Endoscopic vessel harvest device for coronary bypass surgery K ALEIDOSCOPE Reversible IVC filter H OUDINI ® Chronic total occlusion device $3.5M $3.0M $1.5M $2.5M
Slide 7: Proven record of delivering capital and time efficiency
7 Proven record of delivering capital and time efficiency 0 12 24 36 48 60 Typical Company PAVmed Model Months T IME TO 510( K ) C LEARANCE $0 $10,000,000 $20,000,000 $30,000,000 Typical Company PAVmed Model Dollars C APITAL T O 510( K ) C LEARANCE * Typical Company data from Markower, et al. FDA Im
Slide 8: PAVmed built on leadership team's prior success
8 PAVmed built on leadership team’s prior success Leverage proven business model in a long - term multi - product company with an expanding pipeline of innovative products Provide access to seamless capital through the public capital markets
Slide 9: Lead products provide near-term value creation opportunities
9 Lead products provide near - term value creation opportunities NextCath Self - Anchoring Short - Term Catheters NextFlo Highly Accurate Disposable Infusion Pump PortIO Long - term Implantable Vascular Access Device CarpX Percutaneous Device to Treat Carpal Tunnel Syndrome Caldus Disposable Tissue
Slide 10: Multi-product pipeline enhances value creation
10 Multi - product pipeline enhances value creation ENHANCED VALUE CREATION RISK MITIGATION NON - BINARY SUCCESS ECONOMIES OF SCALE FLEXIBLE , DYNAMIC ALLOCATION OF RESOURCES
Slide 11: Board of Directors with industry and capital markets experience
11 Board of Directors with industry and capital markets experience LISHAN AKLOG, MD Chairman, Chief Executive Officer MICHAEL GLENNON Vice - Chairman RONALD M. SPARKS Director Nominating Committee Chair ▪ Former Healthcare Industry Executive, Avista Capital Partners ▪ Former Chairman and CEO, Navily
Slide 12: Multi-Specialty Medical Advisory Board of renowned physician innovators
12 Multi - Specialty Medical Advisory Board of renowned physician innovators ALBERT CHIN MD ▪ Co - founding Partner and Chief Innovation Officer, Pavilion Medical Innovations ▪ Former Vice President of Research and Chief Innovation Officer, Maquet Cardiovascular/ Guidant Cardiac Surgery ▪ Inventor o
Slide 13: The PAVmed Business Model
13 The PAVmed Business Model
Slide 14: Project selection criteria drive commercial opportunity
14 HIGH MARGIN PRODUCT ATTRACTIVE MARKET Project selection criteria drive commercial opportunity COMMERCIAL OPPORTUNITY Cost Of Goods (COGS) Average Sale Price (ASP) UNMET CLINICAL NEED REGULATORY PROFILE REIMBURSEMENT PROFILE TECHNOLOGY PROFILE
Slide 15: Key business processes deliver capital and time efficiency
15 Key business processes deliver capital and time efficiency LIGHT INFRASTRUCTURE/L OW FIXED COSTS FLEXIBLE COMMERCIALIZATION STRATEGY REGULATORY STRATEGY PARALLEL DEVELOPMENT PROCESSES OUTSOURCED BEST - IN - CLASS PROCESS EXPERTS CAPITAL EFFICIENCY SPEED TO MARKET
Slide 16: Flexible commercialization strategy accelerates value creation
16 Accelerate Revenue Growth Flexible commercialization strategy accelerates value creation DIRECT SALES FORCE Call - point specific INDEPENDENT DISTRIBUTOR NETWORK Call - point specific REGULATORY CLEARANCE CORPORATE PARTNER Sales and Distribution Agreement CORPORATE PARTNER Licensing agreement Acq
Slide 17: Product Pipeline
17 Product Pipeline
Slide 18: Lead products provide near-term value creation opportunities
18 PRODUCT ADDRESSABLE MARKET REGULATORY PATH COMMERCIALIZATION INITIAL CHANNEL TARGET DATE PortIO Long - term Implantable Vascular Access Devices $500M/$50M 510(k) Independent Distributors 12 Months Caldus Disposable Tissue Ablation Devices $200M/$100M 510(k) Independent Distributors 15 Months Disp
Slide 19: Patent filings by product
19 PRODUCT INVENTORS TITLE NUMBER DATE PortIO Aklog, deGuzman and Orphanos “Intraosseous Infusion Ports and Methods of Use” Application# US62/0.79.266 US14940889 PCT/US15/60669 Filed 13 - Nov - 2014 13 - Nov - 2015 13 - Nov - 2015 Caldus Aklog and deGuzman “Continuous Flow Balloon Catheter Systems a
Slide 20: PortIO
20 PortIO
Slide 21: PortIO Market Opportunity
21 Market Opportunity 1 iData Research Group, 2013 2 Baskin, et al . Lancet 2009 C LINICAL ▪ Long - term implantable vascular access devices A DDRESSABLE M ARKET ▪ All implantable ports 1 ~$500M ▪ Poor venous access patients ~$50M C URRENT D EVICE L IMITATIONS ▪ Intravascular component ▪ Occlusions
Slide 22: PortIO - The PAVmed Solution
22 PortIO - The PAVmed Solution P ORT IO ▪ Novel, implantable intraosseous vascular access device ▪ No intravascular component L ESS I NVASIVE ▪ Near percutaneous insertion/removal M ORE C OST E FFECTIVE ▪ Not prone to occlusions ▪ No need for regular flushes ▪ No radiographic confirmation necessary
Slide 23: Caldus
23 Caldus
Slide 24: Caldus Market Opportunity
24 Market Opportunity C LINICAL ▪ Ablation of pathologic soft tissues including tumors ▪ Ablation of varicose veins ▪ Renal denervation for refractory hypertension A DDRESSABLE M ARKET ▪ Soft tissue ablation ~$200M/$100M 1 ▪ Varicose Veins ~$100M ▪ Renal denervation ~$5B/$1B 2 C URRENT D EVICE L IMI
Slide 25: Caldus - The PAVmed Solution
25 Caldus - The PAVmed Solution C ALDUS ▪ Completely disposable tissue ablation devices ▪ Direct thermal ablation ▪ No console M ORE C OST E FFECTIVE ▪ No capital and maintenance costs ▪ Lower procedural cost while maintaining margin ▪ Higher temperatures allow shorter ablation times E XPANDED M ARK
Slide 26: CarpX
26 CarpX
Slide 27: CarpX Market Opportunity
27 Market Opportunity C LINICAL ▪ Carpal tunnel syndrome (CTS) ▪ Most common occupational injury A DDRESSABLE M ARKET ▪ ~2 million patients 1 ▪ 350,000 surgeries annually 1 ▪ All CTS patients $1.5B Current Surgical Patients $750M C URRENT D EVICE L IMITATIONS ▪ Invasive surgical procedure ▪ Endoscop
Slide 28: CarpX - The PAVmed Solution
28 CarpX - The PAVmed Solution C ARP X ▪ Completely percutaneous CTS device L ESS I NVASIVE ▪ Truly percutaneous ▪ No surgical incision or dissection M ORE C OST E FFECTIVE ▪ Shift procedures interventional lab or office ▪ Shorten procedural times F EWER C OMPLICATIONS ▪ Better nerve protection ▪ Gr
Slide 29: NextCath
29 NextCath
Slide 30: NextCath Market Opportunity
30 Market Opportunity C LINICAL ▪ Short - term catheters including peripheral venous catheters (PVC) A DDRESSABLE M ARKET 1 ▪ 90% of inpatients receive a PVC ▪ Short - term vascular catheters ~$2B Peripheral venous catheters ~$1B C URRENT D EVICE L IMITATIONS ▪ Catheter dislodgement results in incre
Slide 31: NextCath - The PAVmed Solution
31 NextCath - The PAVmed Solution N EXT C ATH ▪ Self - anchoring, short - term catheters ▪ Integrated semi - stiff helical portion ▪ Applicable to most, if not all, short - term catheters M ORE C OST E FFECTIVE ▪ Eliminate costly catheter securement devices ▪ Less monitoring of catheter security ▪ F
Slide 32: NextFlo
32 NextFlo
Slide 33: NextFlo Market Opportunity
33 Market Opportunity C LINICAL ▪ Disposable infusion pumps (DIP) ▪ Increasing numbers receiving infusions outside hospital A DDRESSABLE M ARKET ▪ DIPs for home use ~$500M C URRENT D EVICE L IMITATIONS ▪ Highly inaccurate in actual use ▪ Dependent on operating conditions ▪ Unsuitable for use with ma
Slide 34: NextFlo - The PAVmed Solution
34 NextFlo - The PAVmed Solution N EXT F LO ▪ Highly accurate disposable infusion pump ▪ Passive variable flow resistor design F EWER C OMPLICATIONS ▪ Prevent complications from infusions running too slow or fast M ORE C OST E FFECTIVE ▪ Reduce or eliminate need for trained healthcare personnel ▪ De
Slide 35: The Future of PAVmed
35 The Future of PAVmed
Slide 36: Near- and long-term opportunities for value creation: Next 12 Months Milestones
36 Near - and long - term opportunities for value creation PortIO FDA submission NextCath FDA submission NextFlo FDA submission PortIO FDA clearance and initial commercialization Caldus General FDA submission Caldus RND CE Mark submission CarpX FDA submission NextCath FDA clearance and initial comme
Slide 37: Near- and long-term opportunities for value creation
37 Near - and long - term opportunities for value creation Rapidly advance lead products to commercialization Execute commercialization strategy Expand pipeline S HAREHOLDER V ALUE
Slide 38: PAVmed Investment Highlights
38 Unique, Proven Business Model Broad, Expanding Pipeline of Innovative Products World - Class Board and Advisors Leadership Team with Strong Record of Value Creation PAVmed Investment Highlights TM