LifeTech Scientific Corporation 先健科技公司. Stock Code: 1302.HK

Transcription

1 LifeTech Scientific Corporation 先健科技公司 Stock Code: 1302.HK May 2017

2 CONTENTS 1 Company Overview 2 Major Innovative Products 3 Vision 2

3 1 Company Overview 3

4 About Us The second largest supplier of occluders to treat congenital heart defect in the world and the second leading brand to treat cardiovascular disease in Mainland China A listed company in Hong Kong Stock Exchange Market with a big potentiality as a global mainstream brand A strategic partner of Medtronic with diversified products and global market layout A promising enterprise with independent intellectual property, leading technology and innovation 4

5 Milestones Pacemaker production line was established The 5 th product was approved as an Innovative Medical Device 2016 Pacemaker workshop was established 2015 Constituent Stock of Hang Seng Index Second Prize of National Technology Invention Award LAmbre TM and IBS were approved as Innovative Medical Devices 2014 National and Local Joint Engineering Laboratory 2013 Strategic cooperation with Medtronic 2012 Invested by a US. VC fund First product obtained CE mark approval Listed on HKEx 2011 Company Establishment First product was approved by CFDA National High-tech Enterprise First product received FDA clearance National Post-doctoral Research Center 5

6 Market Size and Layout Global cardiovascular implant medical devices market size by segment SHD Market Peripheral Vascular Market Cardiac Pacing & Electrophysiology Account for Account for Account for 15% of the total market 45% of the total market 40% of the total market (CHD+LAA+PFO+Valvular Diseases+HypertensionTreatment) (Coronary+Peripheral Vascular) (Pacemaker) Lifetech s market layout * * SHD * Peripheral Vascular Cardiac Pacing & Electrophysiology Note:The products marked * is under R&D 6

7 Growth Strategy Territory Expansion China BRIC EU U.S. Field Expansion Congenital Heart Defect Peripheral Vascular Disease Structural Heart Defect Pacing Electrophysiology Material Technology Innovation Nitinol Biological Coating Bioabsorbable Materials Global Cooperation Cooperate with Medtronic as an example Equity Cooperation Quality System Improvement Channel Cooperation Joint development of new products 7

8 Product Layout Arrhythmia: Pacemaker Coronary Diseases: Absorbable Stent Structural Heart Diseases: ASD/VSD/PDA/LAA/PFO/Mitral Valve Lliac Artery: IBD Aorta Diseases: TAA/AAA/ Open Surgical Stent Graft System Deep Vein Thrombosis: Vena Cava Filter Advanced Heterogeneous Emphysema: LVRR Limb Vessel: PTA/DEB 8

9 Major Marketed Products Well-marketed around 30 innovative products in the global market Main Product Line: Peripheral Vascular Products: sales accounted for 65% of Lifetech s revenue in 2016 TAA/AAA Stent Graft System Vena Cava Filter Steerable Introducer Vascular Plug Snare Dilator Structural Heart Defect Products: sales accounted for 35% of Lifetech s revenue in 2016 VSD/ASD/PDA Occulders Ceramic Coating VSD/ASD/PDA Occulders VSD/ASD/PDA Occulders LAA Closure System PFO Occulders Introducer 9

10 Rigorous Quality Control Multiple Quality Certification Pacemaker Clean Workshop GMP CFDA Flying Inspection Quality Certification Issued by DEKRA, EU FDA Site Inspection of QS/GMP Quality Certification Issued by BSI, EU Introducer Workshop Coating Workshop Balloon Workshop 10

11 The Pioneer for Innovation High R&D Investment R&D staff accounted for 34% of total staff >20% R&D expense is the guarantee for Innovation 400, , ,000 22% 20% 20% 20% 20% 250,000 20% , , ,000 35% 34% % 31% 31% 50,000-4% Revenue R&D Expenses R&D Expenses as % to Revenue R&D Staff Total Staff Exclude R&D Staff Patent Application As at Dec. 31, 2016: R&D Investment 20% Note: The above R&D expenses includs capitalization R&D Staff 34% patents granted in China 182 patents applied in China 75 PCT applications 83 patent applications entering the national stage through PCT 11

12 The Pioneer for Innovation Research Capacity and Qualification Research Programs Organized or Participated in 50+ Programs: National Key Technologies Research and Development Program in China during the 10 th Five-Year Plan Period National "973 Program" National "863 Program" Provincial and Professional Research Projects Research Qualification National and Local Joint Engineering Laboratory National Post-Doctoral Research Center National Laboratory Accreditation Provincial Engineering Research Center (Guangdong) Municipal Engineering Laboratory & Engineering Center (Shenzhen) Industry Standards Drafting Industry Standard of Vena Cava Filters National Standard of Cardiac Intervention Valves Industry Standard of Intravascular Stents Industry and International Standard of Absorbable Intravascular Stents Industry and International Standard of Cardiac occluders Scientific Research Awards Second Prize of National Technology Invention Award First Prize of Science & Technology Development of the Ministry of Education First Prize, Second Prize and Third prize of Provincial Science & Technology Development Award Provincial Gold Award for Outstanding Patented Invention in Guangdong Province Science & Technology Development Award of Shenzhen Shenzhen Outstanding Patented Invention Award 12 12

13 The Pioneer for Innovation Experimental Capacity R&D Centre Laboratory Engaged in preclinical evaluation of medical devices (including drug containing devices) 162 test programs covering physical test, chemical test, metal test, biological and microbiological test of medical devices High-end Animal Laboratory The first animal laboratory possesses clean operation room and interventional catheter room in south China Comprehensive preclinical evaluation experiments services for medical devices The only laboratory provides device implantation experiment, pathological evaluation and pharmacokinetics services at the same time 13

14 Innovation Drives Globalization Innovation Process 2012 World-class QS Brand Effects Global Leader Share Resources with Medtronic Imitation: Difficult to enter global market Partial Innovation: Difficult to be recognized by western countries Best Design & Completed Patent Completed Product Series Independent IP Xuper Procedure Innovation Leading Technology Diversified Product Lines Innovative Technology Single Product Line Imitation Globalization Process Leading Position in the China Market Leading Position in the BRIC Market Entering the EU Market Global Market Leader Entering the US Market 14

15 Global Clinical Cooperation & Exchange Global clinical cooperation centers China U.S. Europe Brazil Middle East 43 Centers 7 Centers 33 Centers 1 Centers 2 Centers Global Exchange KONAR-MF multifunctional occluder showcased at CSI-AP LKEP International Academic Exchange program Lifetech participated in CSI in Germany The LAmbre TM LAA closure system debuted at TCT 2016 A live case by using LAmbre TM LAA closure system at CSI-AP 2016 CSI, Germany 15

16 Global Academic Collaboration Platform International High-end Professional MORE 16

17 Global Distribution Network LifeTech Europe Over 80 Countries Over 160 Distributors Around 20% sales from overseas market LifeTech India LifeTech HQ Shenzhen 17

18 Experienced Management Team Xie Yuehui Chairman & CEO Zhang Deyuan CTO Liu Jianxiong CFO & Company Secretary Zeng Lepeng CMO 18

19 Financial Performance Revenue Operating Profit (RMB 000) YOY 14.2% (RMB 000) YOY 13% 400, , , , , , , ,035 Net Profit 200, , , ,475 (RMB 000) YOY 21.1% 100,000 50, Note: excluding offering and share option expenses, consulting fee and losses on CB to Medtronic 19

20 Corporate Social Responsibility Concerning people s livelihood & focusing on the development of the industry Promoted general knowledge of cardiovascular diseases nationwide Visited the Sichuan-Tibet region for voluntary congenital heart defect screening and treatment Help doctors to improve their level of diagnosis and treatment of cardiovascular diseases through academic exchanges and training Cultivate talents for the development of the industry through National Post-doctoral Research Center September 2010 Chairman and CEO of Lifetech, Mr. Xie Yuehui met with the former General Secretary Hu Jintao and made a brief report Charity Donated CHD occluders worth 1 million RMB to the Hu Dayi "Love Program" Donated VSD occluders to help Brazilian children Donated PDA occluders to the "Chain of Hope" international charity to help children in Jamaica Donated occluders and balloons to "Chain of Hope" to save and treat children in Ethiopia Worked with an Indian charity to provide medical services to those in need Donated CHD occluders to mountainous regions in Tibet Donated CHD occluders to the Red Cross Society, China Guangxi Branch Worked with a Philippine charity to treat CHD children in Philippines "I hope that Lifetech will continue to take responsibility for the health of the people and increase the pace of innovation and development to make even greater contributions to the livelihood of the people." - Hu Jintao 20

21 Social Influence LifeTech has received extensive attention for exemplary performance in improving the technological sophistication of domestic medical devices through independent innovation June 16, 2011 September 2015 December 2016 "Innovation: Development from Two Different Ways Topics in Focus, CCTV-1 "China s Healthcare" Documenting China, CCTV-4 Closure of Congenital Heart Defect Approaching Science, CCTV-10 "Through independent R&D, LifeTech ended American companies long-term monopoly in China s occluder market. The company has made significant breakthroughs in iron-based bioabsorbable coronary stent, renal artery ablation and left atrial appendage closure. Topics in Focus "LifeTech's R&D and production of cardiac interventional medical devices has put an end to China's reliance on imported devices, which has not only significantly reduced the medical costs for domestic CHD patients but also built an excellent image of Chinese medical device companies in the world." China s Healthcare "These extraordinary occluders ended the history that only thoracotomy-based treatment can be used for ventricular septal defects, and from then on, minimally invasive techniques became widely used for ventricular septal defect in China. The devices quickly conquered the world with their perfect design, mature technology and outstanding effects." Approaching Science 21

22 2 Major Innovative Products 22

23 Major Pipeline Products Product Name Status Remark LAmbre TM LAA Closure System Braided Peripheral Stent Graft System CE marked, CFDA registration and US. clinic trial in process CE marked China clinic trial in process Widely recognized by world-renowned doctors The Global second one The Second Generation Stent Graft System (TAA/AAA) Xuper Open Surgery Stent Graft System Drug eluting peripheral balloon catheter (DEB) Internal Lliac Stent Graft System /Lliac Bifurcation Stent Graft System Iron-based Drug-eluting Bioresorbable Coronary Scaffold System CE marked (TAA/AAA) CFDA registration (TAA) China clinic trial in process (AAA) China clinic trial in process China clinic trial in process China clinic trial in process Animal study in process The first rear-release stent graft in China The Global first one, invention patent authorization No intellectual property infringement risk, patented formulation Fulfill Chinese market vacancy, differentiate from existing products which have obtained CE mark approval The Global unique technology path, invention patent authorization Absorbable ASD Closure System Animal study in process The Global first one, fully absorbable Lung Volume Reduction Reverser System Animal study in process Fulfill Chinese market vacancy Implantable Pacemaker Animal study completed Lifetech Brand, High-end technology 15 products in preclinical study, 15 products in research, 7 products in clinical trial, on average 1-2 products will be launched in the market in each year 23

24 01 LAA Closure Device 24

25 Left Atrial Appendage Closure Device Application: Prevent stroke of nonvalvular Atrial Fibrillation (AF) patients with thrombi originating in the LAA Potential Market Size: AF is the most common arrhythmia with 1%-2% prevalence in 7 billion people globally 1 in 3 AF patients on average will suffer from stroke with the mortality and disability over 70% Over 90% thrombi in nonvalvular AF patients originate in LAA The morbidity of AF for those aged over 30 is around 0.7%, meaning that about 9 million people in China, and with additional 0.5 million to 1.5 million AF patients every year The Danger of Stroke: 11% 17% 11% 2% 28% 31% Fatal Severe Neurological Deficit Non-disabling Transient Disabling Unknow 40.00% 35.00% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% The incidence of stroke of AF patients increases significantly with ageing 6.70% Proportion of AF patients suffered from stroke (%) 8.10% 21.30% 36.20% Age Group 25

26 Marketed LAA Closure Devices Watchman LAA Amplatzer Cardiac Plug Occlutech LAA Company: Company: Company: Company: Boston Scientific Abbott Occlutech Lifetech Registration: Registration: Registration: Registration: CE: 2005 CFDA: 2014 FDA: 2015 CE: 2008 CFDA: 2015 CE: 2016 CE:

27 Advantages of LAmbre TM Suitable for a variety of LAA anatomy Most procedure is at the LAA orifice, easy to use with a short learning curve Fully retrievable and repositionable Unique anchoring mechanism for stable device fixation, and clinical trials indicated no occluder embolization Rapid endothelialization, and no thrombosis formation in the long-term after implantation The lowest profile of delivery sheath (8-10Fr), reduces injury to atrial septum and blood vessels 400+ Implantation Globally Green Channel Registration Undergoing Clinical Trial Preparation 27

28 02 Iron-based Bioabsorbable Stent 28

29 Bioabsorbable Stents Application: To treat coronary heart diseases Potential Market Size: Coronary Artery Stenosis: the morbidity is up to 4%-7% for those aged over 40 China has over 25 million people suffered from coronary heart disease, while 4-5 million people suffered from myocardial infarct Why Bioabsorbable Stents? Stents only have function in the first half a year in vascular healing process, and after that, there are probably late negative effects: Long-term anticoagulation: costly and risk for bleeding (Death) Late thrombosis (Death) Fatigue broken struts (Possible Death) Long-term inflammation Restenosis in the stent and the progression of atherosclerosis Compromise for MRI,CT and etc. 3 Days after Implantation Thrombi Iron-based Bioabsorbable Stent Lifetech began its research in 2007 Received major project funding from Guangdong government in 2008 and 2009 Received Shenzhen science and technology program sponsorship in 2009 and 2010 Funded by the National "863 Program" in 2011 Currently at the conclusion phase of animal study 6 Months after Implantation 13 Months after Implantation 29

30 Advantages of IBS 1 Iron-based bioabsorbable stent is expected to be the best stent! Mechanical performance is superior to permanent stents OCT 3 Days after Implantation 3 Months after Implantation 6 Months after Implantation 13 Months after Implantation 2 Ultra-thin scaffold strut 3 3 Reasonable scaffolding time Solutions High Molecule Mg Alloy Fe Alloy Stainless Steel Co-Cr Alloy Materials PLLA Mg-Re Fe-0.1%N 316L L605 Status Abbott CE 2011 FDA 2016 Biotronik CE 2016 Lifetech Animal Study The First Generation Permanent Stent The Second Generation Permanent Stent Yield Strength 30-45MPa 162MPa 561±31MPa 331MPa MPa Strut Thickness 150μm 130μm 50-55μm μm 60-90μm Elastic Modulus 1.2~3.0GPa 45GPa 200±30GPa 190GPa 210GPa Acute Recoil <8% <8% <3% <3% <3% Elongation 2-6% 23% >50% >50% >50% Absorbable Time 3 Years <6 Months (Too Fast) 1-2 Years (E)

31 International Influence To be continue Famous Experts Participation US: Ron Waksman, Renu Virmani EU: Partrick Serruys China: Gao Runlin International Conference Report Invitation TCT 2012, 19, Oct., 2012, USA 5 th Bio-metals, 25, August, 2013, Indonesia TCT 2013, 26, Oct., 2013, USA BRS-ARC, 26, June, 2014, Netherland BRS, 26, July, 2014, Boston, USA 6 th Bio-metals, 29, August, 2015, Italy TCT 2015, 19, Oct., 2015, USA Journal, Article and Book Publishment Characterilization and in vivo evaluation of a biocorrodible nitrided iron stent Short-term safety and efficacy of the biodegradable iron stent in mini-swine coronary arteries Cytotoxicity and its methodology for a bioabsorbable nitrided iron stent (Adopted as an International Standard) Design and characterization of a novel biocorrodible iron-based drug-eluting coronary scaffold The Textbook of BRS, Chapter 2-6, 4-3,

32 03 Pacemaker 32

33 Pacemaker Cooperate with Medtronic to break technology monopoly Global Market Share Medtronic Annual implantation of pacemakers in global mainstream markets There is a great growth potential in China China Mainland: averagely 36 cases/million people 70 % Lifetech s Advantages Technology Advantage: state of the art St. Jude BSC Others U.S.: averagely 1000 cases/million people EU: averagely 951 cases/million people Growth expectation of implantation of pacemakers in partial Asian markets Implantation/Million People Cost Advantage: leveraging of Medtronic s scale Local brand easier to get support and privilege from national medical insurance, tendering and other policies Application of pacemaker technology in other fields (deep brain stimulation, electrophysiology) China Mainland China Hong kong China Taiwan 33

34 Pacemaker Project Milestones Signed a series of agreements transaction was with Medtronic The connected approved by EGM Production line established Entered Green Channel Completed animal study 34

35 3 Vision 35

36 Vision To become a leading global supplier of minimally invasive interventional medical devices to treat cardiovascular diseases! COOPERATION INNOVATION EXECUTION RESPONSIBILITY RECOGNITION 36

37 All for Them! 37

38 THANK YOU