Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - HeartWare International, Inc. | c19083e8vk.htm |
Exhibit 99.1
| Wells Fargo Securities2011 Healthcare ConferenceDoug GodshallChief Executive Officer and PresidentJune 22, 2011 |
| Safe Harbor Statement Forward-Looking Statements This presentation contains forward-looking statements that are based on our management's beliefs, assumptions and expectations and on information currently available to our management. Generally, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements, which generally are not historical in nature. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our expectations regarding (a) regulatory submissions and approvals; (b) our clinical trials, including enrollment in our clinical trials and estimates of regulatory filing dates; (c) our intellectual property position; (d) our perceived ability to develop, receive approval for and commercialize our existing and new products; (e) our expected lead times for achieving milestones and (f) our estimates regarding our preliminary financial results. The forward-looking statements reflect our current view about future events and are subject to risks, uncertainties and assumptions. Accordingly, you should not place undue reliance on our forward-looking statements. Except as required by law, we do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in our forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, "Item 1A. Risk Factors" of our Form 10-K for the year ended December 31, 2010 and subsequent filed reports. For instance, the following important factors could prevent us from achieving our goals and cause the assumptions underlying the forward-looking statements and the actual results to differ materially from those expressed in or implied by those forward looking statements: (a) inability to fund ongoing operations, including raising additional capital to support further development and growth; (b) inability to recruit, retain and motivate appropriately qualified employees; (c) unsatisfactory or uncompetitive clinical outcomes for our products (e.g. high stroke, device failure or adverse event rates); (d) lack of physician acceptance or adoption of our products; and, (e) inability to receive and maintain regulatory approvals and consents (e.g. ISO, FDA etc). Additional information concerning our risk factors and uncertainties is contained in our filings with the SEC and ASX. CAUTION: Investigational device. Limited by United States law to investigational use. |
| Heart Failure A degenerative and terminal diseaseAffects over 20 million people globally (5+ million in the US)1 million new cases diagnosed every year300,000 deaths per year in the US (1 in 8 deaths)At least 1 million patients in NYHA Class IV, the end-stage of the diseaseIn the US, heart failure represents Medicare's greatest area of spendingEstimated annual cost of $37B 1.1M hospital discharges in 2006; up 171% since 1979VADS emerging as only viable option for many with late stage disease Source: Circulation, AHA update, January 2009Heart Failure Society of America / NHLBI |
| 1st Qtr 2nd Qtr 1980 401 350 423 345 439 330 464 310 531 305 557 300 582 295 605 290 634 285 643 270 1990 701 265 764 255 822 250 875 240 874 235 872 235 870 220 957 210 978 205 962 200 2000 999 189 995 178 970 171 2003 1037 Coronary Deaths Coronary deaths are down by half But heart failure has almost tripled (CHART) Heart Failure Source: National Hospital Discharge Survey data. Centers for Disease Control and Prevention/National Center for Health Statistics and National Heart, Lung, and Blood Institute. Enhanced survival in other CV diseases leads to expansion of HF Population Heart Failure: The Final Cardiovascular Disease CAUTION: Investigational device. Limited by United States law to investigational use. |
| Global VAD Market Acceleration Continues * Industry reports, HeartWare estimates, Thoratec estimates CAUTION: Investigational device. Limited by United States law to investigational use. |
| HeartWare(r) Ventricular Assist System HVAD(r) miniaturized implantable blood pump Pericardial placement - no pump pocketProvides up to 10 L/min of flowCentrifugal design, continuous flowHybrid magnetic / hydrodynamic impeller suspensionOptimizes flow, pump surface washing, and hemocompatibilityThin (4.2 mm), flexible driveline with fatigue resistant cablesZero cable fractures CAUTION: Investigational device. Limited by United States law to investigational use. |
| Design Enables Pericardial Placement Design benefitsEfficient powerWide blade impeller enables low fluid stressUser friendly tools may decrease surgery time Pericardial benefitsNo abdominal surgeryNo pump pocketPotential to expand pool of treatable patients Fundamental attributes resonating globally CAUTION: Investigational device. Limited by United States law to investigational use. |
| Simple, Elegant Fluid Dynamics Secondary flow path Washes underside and center post regions Tertiary flow pathProvides fluid "cushion"; washes thrust bearings Primary flow pathWashes flow channels and immediately enters outflow graft Levitated impeller; Free from mechanical contact points CAUTION: Investigational device. Limited by United States law to investigational use. |
| Leading a Small Revolution More than 1,000 HeartWare Ventricular Assist System Implants GloballyHeartWare has grown to 260+ employees todayHeadquarters near Boston, Massachusetts (Framingham)Manufacturing in Miami, Florida Development and operations facility in Kirrawee, NSW CAUTION: Investigational device. Limited by United States law to investigational use. |
| HeartWare: Strengthened Base for Future Growth Maturing commercial organization in EuropeBolstered manufacturing to accommodate clinical ramp in USAugmented field team to educate and service larger commercial and clinical customer basePositioning organization for FDA audit process and US launch preparationExpanded R&D capabilities to accelerate pipelineExpanding Clinical team to manage expanding trial activities CAUTION: Investigational device. Limited by United States law to investigational use. |
| Geographic revenue breakdown Geographic revenue breakdown |
| International Rollout Gaining Momentum CAUTION: Investigational device. Limited by United States law to investigational use. International market growth robustExpanding global acceptance56 customers, 18 countriesReported 134 units sold in Q1Follows 112 in Q3; 161 in Q4Expanded capabilities to capitalize on growing demand; 14 employees France reimbursement approved; pricing expected in H1 '11Belgian reimbursement H1 '11Primary focus remains on optimizing patient outcomes As of 5/5/11 |
| Clinical and regulatory tracking - HVAD United States - Bridge-to-Transplant United States - Continued Access for BTTUnited States - Destination Therapy DT IDE Approved by FDA June 2010 First implants Aug 2010 Began April 2010; Two 54-patient allotments complete; Third enrolling CAUTION: Investigational device. Limited by United States law to investigational use. 46 of 50 sites initiated (as of 5 / 5 / 11) United States - REVIVE-IT (awarded; protocol finalization) |
| Two Largest VAD Trials ADVANCEBridge-to-Transplant140 patients at 30 sites6-month follow up completed 8/2010Control: contemporaneous patients in INTERMACS registryPMA submitted 12/27/10Met primary endpointContinued Access Protocol in place29 of 30 sites initiated in CAP94 ENDURANCEDestination Therapy450 patients at up to 50 centers; randomized 2:1121 patients now enrolledControl: commercially approved DT LVAD2-year follow upSuccess: alive, on original device w/o major strokeProjecting 300 patients enrolled Q4 '11 and 450 in H1 '12 As of 5/5/11 CAUTION: Investigational device. Limited by United States law to investigational use. |
| 94% survival at 180 days, 91% projected survival at 360 daysHVAD pump demonstrated non-inferiority to contemporaneously implanted, commercially available ventricular assist devicesImplantation of the HVAD pump was associated with a 92% probability of success at 180 daysAdverse event profile in line with our expectationsData demonstrated marked improvement in functional capacity and quality of life measurements from patient baseline ADVANCE BTT Trial: Summary of Results CAUTION: Investigational device. Limited by United States law to investigational use. Data cutoff Aug. 23, 2010; 89.45 patient years on support |
| Days Post Implant Proportion of Patients 62.8% Alive 29.2% Transplant 3.6% Death 4.4% Device Exchange 92.0% Transplant or Alive ADVANCE Trial Treatment Group Outcomes (Per Protocol Population) Patients at Risk 137 125 104 86 58 31 22 NOTE: Original device in place for all outcomes CAUTION: Investigational device. Limited by United States law to investigational use. |
| Applying Seattle Heart Failure Model to ADVANCE Figure 1: SHFM Estimated Survival Wayne C. Levy, et al, ISHLT 2011 |
| Overall Survival Comparison: SHFM vs. ADVANCE Figure 1: SHFM Estimated Survival Figure 1: SHFM Estimated Survival Wayne C. Levy, et al, ISHLT 2011 |
| ADVANCE and CAP Update June 21, 2011 |
| ADVANCE:140 patients enrolled - last implant Feb 28, 201052 patients remain on pump (37%) CAP:144 patients enrolled111 remain on pump (77%)BTT / CAP combined: 284 enrolled in both trials for 217 patient-years of support Current Status of ADVANCE and CAP |
| Methodology and Objective Event rates for device exchange for thrombus post discharge, GI bleeding and strokes were compared by time on pump for the following periods:ADVANCE and CAP combined to June 14, 2011 (i.e. the current overall rates): 284 patients for 217 patient-yearsADVANCE and CAP from March 14th to June 14th: 163 patients for 40 patient-yearsObjective: Identify impact of changes to antiplatelet approach (325 mg ASA), if any, and confirm that initial results are as anticipated |
| Distribution of Time on Pump Total = 163 patients on HVAD support during the period March 14 - June 14 Majority of patients confirmed to be on 325 mg (CHART) CAUTION: Investigational device. Limited by United States law to investigational use. |
| (CHART) Exchange Rates for Suspected Thrombus One exchange for thrombus in 163 patients March 14 - June 14 Resembles ISHLT finding of 1 exchange in 73 patient years with 325 mg ASA 217 patient years in BTT/CAP and 40 from March 14 - June 14 CAUTION: Investigational device. Limited by United States law to investigational use. |
| GI Bleeding (CHART) CAUTION: Investigational device. Limited by United States law to investigational use. |
| Stroke Rates Total Trial vs. Recent Quarter Stroke Rates Total Trial vs. Recent Quarter CAUTION: Investigational device. Limited by United States law to investigational use. |
| 284 patients have been enrolled in ADVANCE and CAP for more than 217 patient-years of supportSurvival has been consistently high in all trials to dateSepsis and driveline infections are notably infrequentGI bleeding rate and bleeding in general remain low Full dose aspirin (325 mg) appears to be an ingredient for decreasing risk of pump thrombus without evidence of increased bleeding or hemorrhagic stroke (vs. 0-162 mg) Investigator Update Summary CAUTION: Investigational device. Limited by United States law to investigational use. |
| Development Priorities for 2011 "Evergreen" HVADEnhancements to pump and algorithmsIntroduce new tools to improve implantUpgrade patient accessoriesDrive MVAD to First-in-ManMultiple versions under wayDesign for AE reduction to expand treatable populationAccelerate NG ElectronicsNext Generation ControllerRamping TETS investmentExpanding development on multiple programs Focus areas for accelerated investment CAUTION: Investigational device. Limited by United States law to investigational use. |
| Evergreen HVAD - Enhancements for Next 12 Months Improved patient packs Redesigned product packaging New Apical Coring Tool Sintered inflow cannula Revised controller with updated software Shower bag CAUTION: Investigational device. Limited by United States law to investigational use. |
| Sintered Inflow Sintered Inflow CAUTION: Investigational device. Limited by United States law to investigational use. FDA approved sintering for both BTT/CAP and DT studies in AprilFirst sintered pump implants in May34 sites have already received IRB approval for sintered pumpsBSI approved sintered pumps as supplement to CE Mark in April; Shipping commenced |
| Compelling Pipeline - Miniaturized VAD design Expanded portfolio of MVAD designsExploring new patient populationsMore than 75 animal studies conducted to date; strong early resultsGLP animal studies started Q1 '11First-in-man studies Q1 '12Wide blade impeller with hybrid suspension allows significant miniaturizationUltra-thin driveline Simplified manufacturingPartial or full support attainable; Wear- less impeller suspensionAll versions can eliminate sternotomy Designed to decrease invasiveness without decreasing efficacy CAUTION: Investigational device. Limited by United States law to investigational use. |
| Selected Financial Snapshot RevenueQ1 2011 revenues $18M; up 68% from Q1 in 20102010 revenues of $55M; up 128% from $24M 2009 (CHART) $ Millions Implant rate and growth likely to be variable in 2011Capital structureTreasury exceeds $214M in capital at 3/31Convertible debt $143M ($100 conversion price)Stock on Issue: 13.9M shares |
| Another Busy Year Initiation of MVAD GLP animal studies in Q1 2011 ^Secure reimbursement and launch HVAD in FrancePreparation for PMA audit; potential advisory committee panelISHLT presentation of ADVANCE trial and CAP data ^Drive enrollment in DT and CAPPublication of ADVANCE dataEnroll 300th patient in ENDURANCE DT study by year-endCrystallize BiVad clinical / regulatory pathRoll out multiple HVAD product enhancements ^Accelerate electronics portfolioCommence human clinical studies for MVADPrepare for US launch CAUTION: Investigational device. Limited by United States law to investigational use. |
| Leading a Small Revolution CAUTION: Investigational device. Limited by United States law to investigational use. |