LivaNova Investor & Analyst Meeting. November 30, 2015
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1 LivaNova Investor & Analyst Meeting November 30, 2015
2 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 2
3 Welcome and agenda outline Topic Welcome Overview & Strategy Cardiac Surgery Cardiac Rhythm Management Neuromodulation Emerging Markets New Ventures & Emerging Therapies Financial goals Closing remarks Q&A Session Speaker Dan Moore André-Michel Ballester Michel Darnaud Stefano DiLullo Rohan Hoare Jacques Gutedel Ed Andrle Vivid Sehgal André-Michel Ballester 3
4 Welcome Dan Moore
5 LivaNova board of directors introductions André-Michel Ballester, Chief Executive Officer Francesco Bianchi Stefano Gianotti Hugh Morrison Alfred Novak Dr. Sharon O Kane Dr. Arthur Rosenthal 5
6 February 26, 2015 announcement 6
7 Compelling strategic rationale for LivaNova CHF Partnership Opportunities in Three Multi-Billion Dollar Specialty Markets High Complementary Technologies Global Scale and Geographic Diversification Leadership in Large and Growing Markets Strong Balance Sheet to Execute Plan 7
8 LivaNova CEO introduction Baxter: executive positions in Europe and USA; appointed President, CardioVascular Group, Europe in 1997 Edwards: Vice President EMEA, Asia & Latin American from Sorin: President of Cardiac Rhythm Management in 2004, appointed CEO in 2007 M.S. in Engineering from École Centrale, Lille, France M.B.A. from INSEAD, Fontainebleau, France 8
9 Overview & Strategy André-Michel Ballester
10 Overview A stronger foundation on which to build diversified product portfolio, global scale and strong local presence in all key markets. Enhanced growth opportunities in the Heart Failure, Sleep Apnea and Percutaneous Mitral Valve markets with strengths in technology and market access capabilities. Diversified and wider shareholder base to support further growth opportunities. 10
11 LivaNova strengths Market Leadership in Key Product Areas Opportunities in Three Substantial New Markets Global Scale and Diversification Extensive Technological Expertise Strong Balance Sheet & Cash Flow Passionate, Talented People Rewarded for Performance 11
12 Market leadership in key product areas Global leader in Cardiac Surgery and Neuromodulation Leveraging an innovative Cardiac Rhythm Management platform CARDIAC RHYTHM MANAGEMENT CARDIAC SURGERY NEUROMODULATION Leading innovator in CRM Cardiopulmonary global leader Leader in Neuromodulation with VNS Therapy Strong position in Europe and Japan Innovative products focused on patient outcomes Robust pipeline #1 in Oxygenators #1 in Heart Lung machines Leading player in surgical valves #1 position in devices for epilepsy Pioneer in VNS treatment for heart failure On-going roll out of new products 12
13 and excellent opportunities in three substantial new markets Accelerated development and commercialization of new product categories Heart Failure (HF) Sleep Apnea Percutaneous Mitral Total market potential 1 > $1 billion > $1 billion > $1 billion LivaNova Programs VITARIA Equilia Intense Investment in Respicardia (Central Sleep Apnea) Investment in ImThera (Obstructive Sleep Apnea) Investments in: Caisson, HighLife Cardiosolutions Timing of earliest market entry Commentary Creates broad portfolio strength, technological expertise and market development potential Dual path approach with opportunities in large and under-addressed Central and Obstructive Sleep Apnea markets Programs in both Percutaneous Mitral Repair and Replacement, transapical and transfemoral 1 Estimated cumulative market potential by 2025 following US regulatory approval 13
14 Global scale and diversification Vancouver, British Columbia Denver, Colorado Houston, Texas London, UK Clamart, France Meylan, France Santo Domingo, Dominican Republic Saluggia, Italy Munich, Germany Cantù, Italy Mirandola, Italy Suzhou, China Joint venture, Shanghai, China Alajuela, Costa Rica São Paulo, Brazil Corporate Headquarters Manufacturing Business Unit Headquarters Under construction 14
15 ...with a broad product portfolio and geographical reach Pro forma revenues 1 by geography Pro forma revenues 1 by business unit Rest of World 20% Neuromodulation 25% $1.2bn Europe 40% $1.2bn Cardiac Surgery 52% United States 40% CRM 23% 1 Figures approximated to reflect current exchange rates and estimated 2015 revenue 15
16 Highly complementary technologies and selling capabilities ICD Wireless Exploit shared technologies Heart Failure Complementary Commercialization capabilities Competitive experience in developed markets / therapies MRI - Compatibility Remote Monitoring CRM Market development experience in developing therapies Complementary call points VNS Science & Expertise Rechargeable RV Pacing Sleep Apnea Epilepsy Experience in emerging markets Proven expertise in patient awareness and education 16
17 A proven management team André-Michel Ballester Chief Executive Officer Michel Darnaud President, Cardiac Surgery Stefano Di Lullo President, Cardiac Rhythm Management Jacques Gutedel President, Intercontinental Rohan Hoare President, Neuromodulation Vivid Sehgal Chief Financial Officer Ed Andrle Senior Vice President, New Ventures & Business Development Greg Browne Senior Vice President, Finance Brian Sheridan Senior Vice President, General Counsel & Corporate Secretary Pritpal Shinmar Senior Vice President, Market Access David Wise Senior Vice President, HR, IT & Communications 17
18 driving shareholder value Sales growth Diversified platform for growth Opportunities in new markets Synergies $80 million in planned annual pre-tax synergies by 2018 Optimize supply chain in medium term Operating & EPS Leverage Margin expansion Lower tax rate Balance Sheet & Cash Flow Strong balance sheet & robust cash flow Invest for growth internally & externally 18
19 Cardiac Surgery Michel Darnaud
20 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 20
21 Cardiac surgery technologies DISEASES Coronary artery diseases Congenital heart defects Structural Heart valves diseases (Regurgitation and Stenosis) TREATMENTS Valve replacement Coronary Bypass Valve repair NEED FOR CARDIOPULMONARY BYPASS Mechanical Valves Tissue Valves Sutureless Valves Annuloplasty Rings PRODUCTS Heart-Lung Machines Oxygenators - PTS Autotransfusion Systems (ATS) Cannulae 21
22 Cardiac surgery market $ 2.2B 60% $ 1.5B 40% Heart Valves (HV) $3.7B $4.0B Cardiopulmonary (CP) HV The Cardiac Surgery market is $3.7B in 2014, expected to grow 2.0% per year to reach $ 4.0B in 2018, with growth in each segment estimated as follows: $1.5B ( 1.7B) ( 1.1B) CP $2.2B CP - 1.5% CAGR HV - 2.7% CAGR
23 Considerable opportunities in surgical valve replacement The introduction of TAVR has increased the referral of patients having a positive impact on surgical candidates as well AVR treated patients globally are expected to grow to 5.8% (through 2018) up from 4.0% before TAVR era TAVR cannibalization of operable patients is slowly increasing (estimated 9% today) Procedures ( 000s) 469 TAVR CAGR ( ) 21.4% SAVR trend line SAVR CAGR ( ) 2.3%
24 Cardiac surgery market On-pump procedures & market growth by region USA On pump 2014 (k proc) 328 $3.7B ROW Estimated CAGR % $4.0B ROW CHINA 174 BRIC 5.8% BRIC INDIA 95 JAPAN 2.2% JAPAN GERMANY 83 US 0.3% US TURKEY BRAZIL EU 0.8% EU (E) 24
25 Key growth drivers PERCEVAL HEARTLINK SYSTEM FAST GROWTH COUNTRIES / EMERGING MARKETS The Aortic tissue valve of choice for all patients Fully integrated perfusion system 25
26 Redefining perfusion: the Heartlink system System integration Cardiopulmonary solution 26
27 PERCEVAL the aortic valve of choice Perceval Units Sold* Publication History Perceval Enable Intuity Perceval units sold since CE Mark * 14k units sold since launch 27
28 VIDEO Valve Deployment 28
29 PERCEVAL the aortic valve of choice Removing the barriers to adoption Extended indications Leveraging on key benefits Aggressive Marketing Durability Valve in valve Perceval in hybrid procedure Best practice sharing Multiple valves Regurgitation Bicuspid valves Endocarditis Hemodynamic performance Cross clamp time reduction on improved clinical outcome Vs traditional valves Vs competition Vs TAVR in medium and high risk patients Economic Findings Focus on traditional valves and TAVR 29
30 PERCEVAL the aortic valve of choice Expand Indications Geographic Expansion Expand indications & align intended use Continue publication strategy KOL program FDA approval Japan approval and reimbursement Strengthen global sales team Build local evidence to support economic claims Registration and reimbursement in BRIC and ROW 30
31 Cardiac Rhythm Management Stefano Di Lullo
32 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 32
33 CRM overview product portfolio Low Voltage High Voltage Products Pacemakers CRT-P CRT-D ICDs Disease Bradycardia Heart Failure Tachycardia Pacing Therapy Resynchronization Defibrillation 33
34 CRM overview market growth HV CRM Market ($ billions) CRM -0.1% Expected CAGR High volt. Europe US +0.1% +0.1% -1.5% Low volt. Japan Emerging -0.6% -6.6% +7.9% Estimated Growth 2014 LV Market Volume ASP CRM -0.0% +2.8% -2.9% High Volt. +0.1% +3.1% -3.0% Low Volt. -0.2% +1.7% -2.1% (E) 34
35 CRM overview key market drivers Therapy Base therapy is stable with little innovation Innovation in complementary therapies or diagnostics Heart Failure unmet needs exist New therapies such as VNS Importance of co-morbidities (sleep apnea, hypertension) Customers Remain technology friendly Quick adoption of standards: MRI compatibility, DF4 leads Greater influence of economic buyers but implanting cardiologists remain central Increasing weight of emerging markets 35
36 CRM growth strategy growth drivers 2016 Heart Failure & Co-morbidities Platinium roll-out SonR post-respond Positioning of Sleep Apnea Investment in features Leads: standard, IS-4 MRI: high-voltage devices, high performance Geographic positioning Gain high-voltage market share with Platinium Roll-out of new portfolio: KORA 250 & Platinium Sales & product registration 36
37 CRM growth strategy low voltage Kora 250 Full-body MRI solution with AutoMRI mode Benefits of SafeR (ANSWER study) Size & longevity: unique Launched Q SAM Sleep Apnea Diagnostic Capabilities Reliable and automatic screening to detect severe Sleep Apnea 1 Specificity: 85% Sensitivity: 89% Build awareness and referrals PSG SAM 1. Defaye P, de la Cruz I, Martí-Almor J et al. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: The DREAM European study. Heart Rhythm 2014;11:
38 CRM growth strategy high voltage Platinium Differentiating longevity: 14.3 years (VR) Best-of-class size/shape: 31.2cc Ergoform (VR) Our DNA: SonR, Parad+, SafeR, BTO Launched Launched H SonR Automatic CRT optimization Improving CRT response 2 CLEAR study: 23% improvement RESPOND study ongoing patients in 100+ centers 1 st results in H % SonR p = 0, % Control 2. Ritter P, Delnoy PP, Padeletti L et al. A randomized pilot study of optimization of Cardiac Resynchronization Therapy in sinus rhythm patients using a Peak Acceleration Sensor vs. standard methods. Europace 2012;14(9):
39 CRM growth strategy summary Premium positioning based on innovative products focusing on patient outcomes Focus on heart failure and co-morbidities to differentiate our portfolio Selective features investments to maintain the base business Tailored geographic positioning to target high-growth segments Continuous manufacturing cost improvement to offset price erosion 39
40 Neuromodulation Rohan Hoare
41 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 41
42 Epilepsy by the numbers 4 th most common neurological disease after migraine, stroke and Alzheimer's disease 10 Million People living with epilepsy in United States, Europe, and Japan 30% fail to achieve Seizure control after 2 AED failures 3% chance of seizure freedom after 2 AED failures Direct and Indirect Cost $13.5B Mortality rate vs. general population 25-40x Mortality rate vs. general population Source: CDC, WHO, IOC report on Epilepsy 42
43 Epilepsy treatment gap reveals opportunity for VNS Therapy Epilepsy patients 10m Referral Gap Drug resistant 3m Evaluated at EMU ~300k / yr Treated Surgery/Other ~7k /yr VNS ~8k /yr Treatment Gap Prevalence data and approximations based on CDC. 43
44 VNS Therapy: A comprehensive solution for a complex disorder Seizure reduction that improves over time Improved seizure profiles and recovery from seizures that do occur Improved overall patient quality of life Strong Health Economics VNS Therapy can be combined with any other treatment to give patients the best chance of wellness 44
45 VNS Therapy Post-Approval Responder Rate Strong clinical evidence for VNS Therapy No medication changes were allowed during the study period >1,000 peer-reviewed publications on VNS Therapy 45
46 Seizure termination with AspireSR Automatic Stimulation Over 60% of seizures treated ended during automatic stimulation Stimulation-associated desynchronization 46
47 Seizure Start Timing matters! Longer seizure For seizures that ended during stimulation: Earlier stimulation = Shorter seizures Shorter seizure Earlier stimulation Later stimulation 47
48 Strong economic value proposition VNS Therapy Offers: Strong Health Economics Reduced Hospitalization Reduced ER Visits Reduced Accidents Reduced Medications Repeatable Regardless of Country Regardless of Currency Regardless of Health System 48
49 Future advancements for neuromodulation Improve efficacy Stimulation timing Waveforms Improve patient outcomes Miniaturize for comfort and cosmetics Detect dangerous conditions Diagnose Capture Seizure Profiles, Rates & Trends 49
50 Key growth drivers Established market development capabilities Strong health economic profile New patient growth returned to historic highs Significant replacement generator revenue Increasing access to international markets 50
51 Emerging Markets Jacques Gutedel
52 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 52
53 Emerging markets expected growth drivers Rest of World 86% BRIC 4% Other EM 10% Rest of World 82% BRIC 6% Other EM 12% Emerging Markets remain a key growth opportunity Most emerging countries have good economic fundamentals Demographics combined with underdeveloped markets Emerging Markets currently account for approximately 14% of sales Optimize by going direct Significant opportunity for Neuromodulation 53
54 LivaNova benefits for Neuromodulation Leveraging extensive footprint to accelerate the growth of Neuromodulation in Key Emerging Markets Enhancing the focus and increasing our resources in key growth countries Commercial infrastructure supporting the growth of Neuromodulation Dedicated resources for regulatory, reimbursement, government affairs Different models for different businesses and countries From traditional distributor to hybrid and direct models Customized approach, e.g. China 54
55 CS growth strategy China expansion Implementing a three-tier localization approach Serving China Made in China LivaNova is already a significant player in cardiac surgery #1 in heart-lung machines (HLM) #1 in imported oxygenators #1 in mechanical heart valves New Manufacturing plant built in Suzhou for local made Oxygenators CFDA registration under preparation Innovated in China Developing Perfusion Tubing Kits responding to the needs of Chinese Perfusionists 55
56 CRM growth strategy China expansion Implementing a three-tier localization approach Setup of a strong S&M team Serving China Expansion of addressable market through provincial tenders Execution of an aggressive sales growth plan Made in China Local assembly line set up in 12 months and ready to manufacture CFDA registration process initiated Innovated in China Invest in local CRM R&D tailored to the Chinese market Example: Leads program on the way to FIM Including innovative products and services Example: Issuance of the first e-id card on 6 th Aug. 56
57 Emerging markets the growth drivers $350 $300 $250 $200 $150 $100 $50 $- Emerging Market revenues FY 12 FY13 FY14 FY15 FY18 Upfront investments made in building local competencies and infrastructure Successful development of Neuromodulation Focused deployment and targeting of resources, aligning around customers at country level Emerging Markets to grow in the mid-teens and expected to become 18% to 20% of LivaNova revenues Cardiac Surgery & CRM Neuromodulation 57
58 New Ventures Edward Andrle
59 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 59
60 LivaNova s new product opportunities Heart Failure Sleep Apnea Percutaneous Mitral HF represents the largest unmet clinical need in the cardiovascular space. Estimated direct and indirect cost of HF in the US is ~$35B per annum. CSA significantly increases progression through HF and elevates mortality. Untreated OSA increases overall mortality by 86%. TMVR might be the next multi billion dollar med tech opportunity, one that is potentially 4x larger than TAVR. The estimates of market size and opportunity presented above are approximate and based on the Company s analysis as of the current date. 60
61 Heart failure market opportunity HF population WW, pef and ref Prevalence HF population Class II/III, pef and ref Prevalence HF population Class II/III, pef and ref Incidence ART potential indication* *pending clinical evidence Heart Failure 1 20m 12m 2.6m 1.2m Yearly candidates for ART procedure 600k ART = Autonomic Regulation Therapy Estimated number of CRT procedures in 2015 = ~230k 1 The estimates of market size and opportunity presented above are approximate and based on the Company s analysis as of the current date. 61
62 LivaNova heart failure portfolio VITARIA TM & Equilia TM ART +D Enopace Standalone autonomic regulation therapy (ART) for treatment of heart failure VITARIA completed 60 patients clinical study with 12 mo F/U for HFrEF Enrolling 60 patients in HFpEF study Integrated ART system combining VNS with an ICD in a single implantable pulse generator Avoiding 2 procedures in ~70% of ref patients Intra-Aortic Left Vagal Afferents Electrical Stimulation Intra-Aortic Scaffold w/ Wireless Energy Reception Recently initiated clinical trial CE Mark on both 62
63 Central sleep apnea increases mortality and hospital readmissions in patients with heart failure CSA Significantly Increases Mortality in Heart Failure Patients CSA Increases the Risk For Heart Failure Readmissions SURVIVAL % AHI less than 5 per hour AHI equal or greater than 5 per hour 55% % Class II, III Patients Only 0 p=0.02 Javaheri, et. al.: JACC 49(20): , y MONTHS 63
64 Central sleep apnea opportunity 1 Central Sleep Apnea in Heart Failure - US Respicardia HF Population/ HF Population in NYHA Class II/III 6.0m/3.6m 27% of HF population moderate mod-to-severe CSA (NYHA II and III) 20% Diagnosed 980k 195k 80% Candidates for Surgery 60% meet criteria for Phrenic Nerve Stimulation 156k 93k Phrenic Nerve Stimulation Transvenous phrenic nerve stimulation treats central sleep apnea by restoring a more natural physiologic breathing pattern Completed pivotal trial enrollment and expect to file PMA application in 2016 Distribution in Germany, Switzerland, & Spain 1 The estimates of market size and opportunity presented above are approximate and based on the Company s analysis as of the current date. 64
65 Obstructive sleep apnea opportunity 1 8% Prevalence in total population 25% Diagnosed Obstructive Sleep Apnea: US 25m people living with OSA 6.3m ImThera 75% CPAP Penetration 46% Non-Compliant 40% Moderate-to-Severe OSA 80% Candidates for Surgery 80% meet criteria for Hypoglossal Nerve Stimulation 4.7m 2.2m 880k 700k 560k Hypoglossal Nerve Stimulation Targeted hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA) by restoring muscle tone to the tongue and upper airway Initiated Pivotal clinical trial enrollment in mid-2015 CE Mark in The estimates of market size and opportunity presented above are approximate and based on the Company s analysis as of the current date. 65
66 Transcatheter mitral valve replacement active M&A market in
67 Percutaneous mitral market opportunity 1 Mitral Regurgitation US Prevalence A Largely Untreated Patient Population Total MR patients Eligible for treatment MR 3+ Annual incidence Annual MV Surgery 4,100,000 1,670, ,000 60,000 Untreated Large and Growing Clinical Unmet Need Global Market Estimate ($billion) $ Repair $1.1 Replacement $1.8 1 The estimates of market size and opportunity presented above are approximate and based on the Company s analysis as of the current date. 67
68 Percutaneous mitral valve investment portfolio HighLife Caisson Cardiosolutions Mitral Replacement Mitral Replacement Mitra-Spacer System Trans-Apical or Trans-Atrial delivery of subannular ring and stented valve Currently in preclinical phase with clinical trials expected to start in 2016 Trans-Femoral unique transseptal access- delivery of anchor and stented valve Currently in preclinical phase with clinical trials expected to start in 2016 Trans-Apical delivery of balloon with heart pad anchoring at apex and subcutaneous port Initiated FIM feasibility study in London 68
69 excellent opportunities in billion dollar specialty markets Heart Failure Sleep Apnea Percutaneous Mitral Total Expected Market Potential 1 > $1 billion > $1 billion > $1 billion LivaNova Programs Earliest Expected Market Entry (EU) Strategy VITARIA Equilia ART+D Investment in Enopace Investment in Respicardia (Central Sleep Apnea) Investment in ImThera (Obstructive Sleep Apnea) Investments in Caisson, HighLife, Cardiosolutions Creates broad portfolio strength, technological expertise and market development potential Dual path approach with opportunities in large and underaddressed Central and Obstructive Sleep Apnea markets Programs in both Percutaneous Mitral Repair and Replacement 1 The estimates of market size and opportunity presented above are approximate and based on the Company s analysis as of the current date. 69
70 Financial Review Vivid Sehgal
71 Forward-looking statements This presentation contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe our future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," could, seek, guidance, predict, potential, likely, "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation are based on information presently available to us and assumptions that we believe to be reasonable, but are inherently uncertain. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control. You are cautioned that all such statements involve risks and uncertainties, including without limitation, risks that the businesses of Cyberonics, Inc. and Sorin S.p.A. (together, we, us, LivaNova, the Company ) will not be integrated successfully or that we will not realize estimated cost savings, value of certain tax assets, synergies and growth, or that such benefits may take longer to realize than expected. You should carefully consider the foregoing factors and the other risks and uncertainties that affect our business, including those described in the Risk Factors section of our Registration Statement on Form S-4, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents we file from time to time with the United States Securities and Exchange Commission. We do not give any assurance (1) that we will achieve our expectations or (2) concerning any result or the timing thereof, in each case, with respect to any regulatory action, administrative proceedings, government investigations, litigation, warning letters, consent decree, cost reductions, business strategies, earnings or revenue trends or future financial results. Forward-looking financial information and other metrics presented herein represent our key goals and are not intended as guidance or projections for the periods presented herein or any future periods. We do not undertake or assume any obligation to update publicly any of the forward-looking statements in this presentation to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forwardlooking statements. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this presentation. 71
72 Expected Deliverables 2016 financial goals A Year Of Strategic Delivery Leveraged Income Growth with Balance Sheet Strength goals Accelerate Sales Growth Significant Operating Leverage Non-GAAP Earnings Accretive Merger Integration and Synergies Product Portfolio Optimization Strong Balance Sheet and Cash Generation 72
73 Sales growth goal 2016 Growth Goal Expected Growth Drivers 4% 6% Key Product Launches: KORA 250 Platinium Perceval ~2% 2016 AspireSR Penetration 2015 INSPIRE Market Share Gains Emerging Markets Strength Note: the financial information and other metrics presented above represent our key goals and are not intended as guidance or projections for these or any future periods. 73
74 Sales growth goals by business unit 2016 CARDIAC RHYTHM MANAGEMENT CARDIAC SURGERY NEUROMODULATION 4% to 6% 1% to 2% 8% to 10% Note: the financial information and other metrics presented above represent our key goals and are not intended as guidance or projections for these or any future periods. 74
75 Key metrics Sales Growth Goal 4% - 6% 5% - 7% Adjusted non-gaap EPS Goal $ $3.00 >20% growth p.a. Note: the financial information and other metrics presented above represent our key goals and are not intended as guidance or projections for these or any future periods. 75
76 Diversified growth medium term Revenue Growth Goals Expected Drivers 2% New Products Launches Emerging Markets New Ventures 5% 7% Total Growth Note: the financial information and other metrics presented here represent our key goals and are not intended as guidance or projections for these or any future periods. Base Business
77 Key financial goals medium term 2016 Margin % Margin Trend Gross Margin Mid 60 s bps / year SG&A Mid 30 s Low 30 s R&D 10% - 12% 10% - 12% Tax Rate Mid 20 s -100 bps / year Note: the financial information and other metrics presented above represent our key goals and are not intended as guidance or projections for these or any future periods. 77
78 Expected synergies Selective Reinvestment and Leverage Synergies At least $80M Synergies delivered by 2018 $80M Commitment - 20 Project Teams established to deliver $58M - CEO, CFO and BU Presidents on Steering Committee Focus Little impact on customer facing areas Main areas of focus: - Corporate Overhead $19M R&D Optimization - Manufacturing Heart failure - Neuromodulation Revenue Note: the financial information and other metrics presented above represent our key goals and are not intended as guidance or projections for these or any future periods. 78
79 Shareholder value Value Drivers Capital Allocation Accretion Potential Adjusted EPS Goal $2.80 $3.00 Operational Efficiencies Key Product Launches New Ventures Adjusted EPS Goals >20% growth p.a. Capital Allocation Emerging Markets Note: the financial information and other metrics presented above represent our key goals and are not intended as guidance or projections for these or any future periods. 79
80 Closing Remarks André-Michel Ballester
81 driving shareholder value Sales growth 5% to 7% in 2018 leveraging strong base business and emerging technologies Synergies $80 million in planned annual pre-tax synergies by 2018 Operating & EPS Leverage Adjusted non-gaap EPS: > 20% growth per year Balance Sheet & Cash Flow Accretion potential through Capital Allocation 81
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