Novadaq Technologies January 2016

Embed Size (px)

Citation preview

  • 7/23/2019 Novadaq Technologies January 2016

    1/28

    Empowering Physicians withImaging at the Point of Care

    January 2016

    1

  • 7/23/2019 Novadaq Technologies January 2016

    2/28

    The statements and discussions contained in this presentation that are not historical factsconstitute forward-looking statements, which may be identified by the use of forward-lookingwords, including but not limited to,believes, expects, may, intends, anticipates, plans,estimates and analogous or similar expressions intended to identify forward-lookingstatements. These forward-looking statements and estimates as to future performance,estimates as to future valuations and other statements contained herein regarding matters thatare not historical facts, are only predictions, and that actual events or results may differmaterially. We cannot assure or guarantee you that any future results described in thispresentation will be achieved, and actual results could vary materially from those reflected in

    such forward-looking statements due to numerous known and unknown risks and uncertainties,including theRisk Factors described in our filings with the Ontario Securities Commission andthe U.S. Securities and Exchange Commission. Information contained in this presentation hasbeen compiled from sources believed to be credible and reliable. However, we cannotguarantee such credibility and reliability. The forecasts and projections of events containedherein are based upon subjective valuations, analyses and personal opinions. All forward-looking statements are qualified in their entirety by this cautionary statement, and Novadaqundertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof.

    This presentation shall not constitute an offer to sell or the solicitation of an offer to buy anysecurities. Such an offer or solicitation, if made, will only be made pursuant to an offeringmemorandum and definitive subscription documents.

    NOVADAQ, SPY, PINPOINT and LUNA are registered trademarks of Novadaq TechnologiesInc. DermACELL is a registered trademark of LifeNet Health.

    2

    Forward Looking StatementsNASDAQ:NVDQ, TSX:NDQ

  • 7/23/2019 Novadaq Technologies January 2016

    3/28

    3

    SPY Fluorescence Imaging

  • 7/23/2019 Novadaq Technologies January 2016

    4/28

    SPY Imaging Transforms Surgical Intervention andTherapy Delivery in Complex High Risk Open Surgery

    SPY Elite System

    Colorectal Surgery

    Breast Reconstruction

    Assess tissue perfusion, segmenthealthy from abnormal tissue

    Vascular Surgery

    Assess blood inflow and outflowand tissue perfusion

    Assess tissue perfusion, guidetransection margins

    Assess microvascular blood flow,anastomotic patency and perfusion

    Head and Neck Surgery

    Colorectal Surgery

    4

  • 7/23/2019 Novadaq Technologies January 2016

    5/28

    SPY Imaging Transforms Surgical Intervention and TherapyDelivery in Complex, High Risk Minimally Invasive Surgeries

    Colorectal Surgery

    Assess tissue perfusion,healthy versus unhealthy tissue

    Lap Cholecystectomy

    Visualize critical anatomy, suchas bile and cystic ducts

    PINPOINT System

    SLN

    Visualize lymph nodes*,improve cancer staging

    Gynecological Cancer*

    Bariatric Surgery

    Visualize tissue perfusionand critical anatomy

    *Not yet cleared of approved by the U.S. FDA 5

  • 7/23/2019 Novadaq Technologies January 2016

    6/28

    SPY Imaging Transforms Outpatient Assessment of Wounds

    Limb Salvage

    Visualize hyperemia for betterstaging of wound disease

    LUNA System

    15

    5

    Serial Functional Imaging and Analysis

    LUNA Score

    6

  • 7/23/2019 Novadaq Technologies January 2016

    7/28

    Single Technology Platform Creates a Continuum of Care Ecosystem

    NOVADAQ Surgery

    Today

    PINPOINT

    Minimally Invasive SPY Elite

    Open

    FireflyRobotic

    NOVADAQ Diagnostics

    Today

    LUNA

    Wound Care

    Operating Room Primary Care Physician

    Tomorrow

    Next molecule

    Tomorrow

    Laser Doppler

    Outpatient ClinicOperating Room Primary Care PhysicianOutpatient Clinic

    NOVADAQ is the only company that can provide a comprehensivefluorescence imaging solution to all hospital departments

    DermACELL PRS DermACELL WH7

  • 7/23/2019 Novadaq Technologies January 2016

    8/28

    175+

    200,000

    +650+

    Standalone Systems

    1700+FireFly Systems

    Includes SPY technology licenses to ISRG

    Data as of Dec 2015

    SPY Imaging Proven Across Multiple Specialties

    Peer ReviewedPublications

    SPY TechnologyProcedures SPY Hospitals

    DocumentedApplications

    75

    8

  • 7/23/2019 Novadaq Technologies January 2016

    9/28

    Top 50 Cancer Hospitals* Use SPY

    University of Texas M.D. AndersonCancer Center

    Houston, TX

    Memorial Sloan-Kettering Cancer CenterNew York, NY

    Johns Hopkins HospitalBaltimore, MD

    Mayo ClinicRochester, MN

    Dana-Farber/Brigham and Women's

    Cancer CenterBoston, MA

    University of Washington Medical Center

    Seattle, WA

    Massachusetts General Hospital

    Boston, MA

    UCSF Medical Center

    San Francisco, CA

    Cleveland ClinicCleveland, OH

    Ronald Reagan UCLA Medical CenterLos Angeles, CA

    Duke University Medical CenterDurham, NC

    Stanford Hospital and ClinicsPalo Alto, CA

    University of Michigan Hospitals andHealth CentersAnn Arbor, MI

    University of Chicago Medical CenterChicago, IL

    Hospital of the University of PennsylvaniaPhiladelphia, PA

    Barnes-Jewish Hospital/WashingtonUniversity

    Saint Louis, MO

    City of HopeDuarte, CA

    Moffitt Cancer CenterTampa, FL

    New York-Presbyterian UniversityHospital of Columbia and Cornell

    New York, NY

    Ohio State University James CancerHospital

    Columbus, OH

    Northwestern Memorial HospitalChicago, IL

    University of Maryland Medical CenterBaltimore, MD

    University of Minnesota Medical CenterMinneapolis, MN

    Yale-New Haven HospitalNew Haven, CT

    NYU Langone Medical CenterNew York, NY

    Vanderbilt University Medical CenterNashville, TN

    Roswell Park Cancer InstituteBuffalo, NY

    University of Iowa Hospitals and ClinicsIowa City, IA

    University of Wisconsin Hospital andClinics

    Madison, WI

    UPMC-University of Pittsburgh MedicalCenter

    Pittsburgh, PA

    Thomas Jefferson University HospitalPhiladelphia, PA

    Cedars-Sinai Medical CenterLos Angeles, CA

    Beth Israel Deaconess Medical CenterBoston, MA

    University of Colorado HospitalAurora, CO

    Shands at the University of FloridaGainesville, FL

    University Hospitals Case Medical CenterCleveland, OH

    Emory University HospitalAtlanta, GA

    Fox Chase Cancer CenterPhiladelphia, PA

    University of California, Davis MedicalCenter

    Sacramento, CA

    Rush University Medical CenterChicago, IL

    Mount Sinai Medical Center NYUNew York, NY

    Hackensack University Medical CenterHackensack, NJ

    Wake Forest Baptist Medical CenterWinston-Salem, NC

    University of Kansas HospitalKansas City, KS

    Magee-Womens Hospital of UPMCPittsburgh, PA

    Mayo ClinicJacksonville, FL

    UC San Diego Medical CenterSan Diego, CA

    University of Virginia Medical CenterCharlottesville, VA

    USC Norris Cancer HospitalLos Angeles, CA

    University of California, Irvine MedicalCenter

    Orange, CA *U.S. News and World Report Rankings 2015 9

  • 7/23/2019 Novadaq Technologies January 2016

    10/28

    $10.3$11.2

    $12.1$13.0

    $11.7

    $15.1

    $17.0

    $20.0 *

    $6.0

    $8.0

    $10.0

    $12.0

    $14.0

    $16.0

    $18.0

    $20.0

    $22.0

    Q12014

    Q22014

    Q32014

    Q42014

    Q12015

    Q22015

    Q32015

    Q42015

    Millions$

    Total Revenue

    528

    559

    581591

    575

    611

    647

    450

    470

    490

    510

    530

    550

    570

    590

    610

    630

    650

    Q12014

    Q22014

    Q32014

    Q42014

    Q12015

    Q22015

    Q32015

    Q42015

    Units

    Install Base

    $3.7$3.4

    $4.3

    $5.0 $4.9

    $5.7

    $6.1

    $2.0

    $2.5

    $3.0

    $3.5

    $4.0

    $4.5

    $5.0

    $5.5$6.0

    $6.5

    Q12014

    Q22014

    Q32014

    Q42014

    Q12015

    Q22015

    Q32015

    Q42015

    Millions$

    Recurring Revenue

    $6.7 $6.9

    $7.8

    $9.1

    $7.5

    $10.7

    $12.6

    $4.0

    $5.0

    $6.0

    $7.0

    $8.0

    $9.0

    $10.0

    $11.0

    $12.0

    $13.0

    $14.0

    Q12014

    Q22014

    Q32014

    Q42014

    Q12015

    Q22015

    Q32015

    Q42015

    Millions$

    Gross Margin

    Financial and Corporate Performance

    10

    * Preliminary Unaudited

  • 7/23/2019 Novadaq Technologies January 2016

    11/28

    1. Improving clinical outcomes that result in true, realizable economic benefit

    E.g. reductions in anastomotic leaks in colorectal surgery

    2. Enabling new surgical procedures not possible without physiologic imaging

    E.g. single stage and nipple sparing mastectomy and breast reconstruction

    3. Delivering more effective life saving surgeries

    E.g. statistically reducing the probability of cancer reoccurrence and repeat

    surgeries

    ..NOVADAQs value proposition

    Value Based Healthcare Defined

  • 7/23/2019 Novadaq Technologies January 2016

    12/28

    PILLAR II: 11-center U.S. prospective trial of perfusion assessmentduring left-sided colectomy and LAR in 139 patients

    represents the anastomotic leak rate in resectionsperformed in the PILLAR II trial11.4%

    12.6%of low anterior resections performed in theBSLR study resulted in an anastomotic leak2

    1. Jafari et al. JACS. Submitted 20142. Senagore A, et al. Dis Colon Rectum. 2014 Mar;57(3):32430

    1. Improving Clinical Outcomes, Realizable Economic Benefit in

    Colorectal Surgery

    Use of PINPOINT led to a change in operative plan in 8% of procedures,resulting in a 0% anastomotic leak rate in patients where a change was made1

    12

  • 7/23/2019 Novadaq Technologies January 2016

    13/28

    2. Enabling New Surgical Procedures Not Possible WithoutPhysiologic Imaging

    SPY Enables Single Stage ReconstructionEliminates a second s urgery and mu lt ip le post-operat ive fol low -up s

    13

  • 7/23/2019 Novadaq Technologies January 2016

    14/28

    Excellent Perfusion to Nipple Area Poor Perfusion to Nipple Area

    2. Enabling New Surgical Procedures Not Possible WithoutPhysiologic Imaging

    Images Courtesy of Geoffrey Gurtner, MD, Stanford, CA

    Nipple sparing mastectomy is overwhelmingly in demand because the techniqueallows for a more aesthetically and emotionally pleasing outcome for patients

    14

  • 7/23/2019 Novadaq Technologies January 2016

    15/28

    1., 2. Improving Clinical Outcomes and Enabling New SurgicalProcedures

    The Clinical Efficacy and Financial Impact of Laser-assisted Indocyanine Green Angiography on Implant-based BreastReconstruction at a Large Academic Medical CenterAbstract presented by Christian A. Harless, MD; Sue Visscher, PHD;

    Steven R. Jacobson, MD, Mayo Clinic, Rochester, MN, at the Plastic Surgery Research Council Meeting, May 15, 2015

    Breast Reconstruction 2011-2013 Without SPY With SPY Total

    No. of Patients 590 352 942

    Any Complications 100 (17%) 21 (6%) 121 (12%)

    Skin Necrosis 32 (6%) 2 (1%) 34 (4%)

    Nipple Sparing 28% 32% 60%

    Single Stage Direct Implant 7% 23% 30%

    Authors Conclusions:

    The average cost of a necrotic event was $14,441. Modeling these results demonstrate a potential avoidance of 59 episodes of skin necrosis

    through the use of SPY. At an average cost of $14,441 per necrotic event, use of SPY would result in a total cost

    savings of $852,019 over a 5 year period.

    15

  • 7/23/2019 Novadaq Technologies January 2016

    16/28

    3. Delivering More Effective Lifesaving Surgeries

    Plante et al., Gyn Onc, 2015 (n=50)Howe et al., Gyn Onc, 2015 (n=100)

    Technique SLN identified Bilateral SLNs Identified

    Technetium Only 83% 19%

    Blue Dye Only 79% 50%

    Blue Dye + Technetium 87% 54%

    PINPOINT Imaging Only 96% 88%

    Sentinel Lymph Node (SLN) Identified in Gynecological Cancers

    5-year survival in stage II- IV in ovarian cancer at best case is 70% and the worsecase is 17%. 85% of patients with these types of cancers are in stage II- IV.

    16

  • 7/23/2019 Novadaq Technologies January 2016

    17/28

    Changing the Healthcare Delivery Paradigm- MedicareReadmission Reduction Program

    Procedure30-day

    ReadmissionRates

    Est. # ofPatients

    Readmitted

    Est.Annual

    Cost

    Cholecystectomy 9.5% 53,065 $3.9B

    Colorectal Resection 14.8% 23,184 $2.2B

    Open, Heart Bypass Surgery 15.1% 26,200 $0.4B

    Debridement of Wound 19.1% 416,000 $5.0B

    Amputation of Lower Extremity 22.8% 26,400 $4.2B

    Weiss, et al., AHRQ Pub. No. 10 (11)- EHC009-2-EF. Agency for Healthcare Research and Quality, Rockville, MD 2013,Centers for Disease Control, 2015, Modern Healthcare December 10 2015, www.CMS.gov

    758 U.S. hospitals were penalized in 2015, 54% were teaching institutions Medicare is expected to reduce spending by $364M Hospital and physician performance data is made public and easily searchable

    The Hospital Readmissions Reduction Program is part of the CMS effort to aggressivelymove towardpaying for high performance rather than paying for volumes of services

  • 7/23/2019 Novadaq Technologies January 2016

    18/28

    Guaranteed By SPY

    When SPY is used in the first surgery and a

    revision is still necessary, well pay for the tissue.

    18

  • 7/23/2019 Novadaq Technologies January 2016

    19/28

    Opportunity > 2 Million Complex, High Risk

    Procedures / Year in U.S.

  • 7/23/2019 Novadaq Technologies January 2016

    20/28

    Application Pts. /Year (U.S.) Surgery Type Device

    Breast Reconstruction 100,000 Open SPY

    Other Reconstruction 250,000 Open SPY

    Vascular 100,000 Open SPY

    Abdominal Wall 50,000 Open SPY

    Maxillofacial / Head & Neck 100,000 Open SPY

    Gastrointestinal 200,000 Open or MIS SPY / PINPOINT (50:50)

    Lymphatic 400,000 Open or MIS SPY / PINPOINT (25:75)

    Gynecological Oncology 100,000 MIS PINPOINT

    Cholecystectomy 100,000 MIS PINPOINT

    Wound Healing 600,000 Outpatient LUNA

    Opportunity Associated with Complex, HighRisk Segment of Key Applications

    ASPS and SAGES Procedure Statistics, 2015 Medtech Insight Report, U.S. Surgical Volumes 2014-2020

    20

  • 7/23/2019 Novadaq Technologies January 2016

    21/28

    Procedure Opportunity per System70% Surgery, 30% Wound Healing

    40%

    30%30%

    Wound Healing

    MIS Surgery

    Open Surgery

    Additional commercial relationships: LifeNet Health, Arthrex, ISRG

    21

  • 7/23/2019 Novadaq Technologies January 2016

    22/28

    Growth Drivers

    1. Expanded, Focused Sales Channels

    2. International Expansion

    3. New Product Introductions 2016

    4. Outcomes Based Level I Clinical Studies

    (FILM Trial)

    (PILLAR III)

    5. New Imaging Molecules

  • 7/23/2019 Novadaq Technologies January 2016

    23/28

    1. Expanded, Focused Sales Channels

    %

    10%

    20%

    30%

    40%

    50%

    60%

    70%

    Surgery Wound Care

    % Opportunity

    23

  • 7/23/2019 Novadaq Technologies January 2016

    24/28

    2. International Expansion

    Key Markets

    Europe: United Kingdom, Germany and the Nordics

    Asia: China, Japan, Korea

    Sales Channels Regional distributors in place

    NOVADAQ direct management and subsidiary companies in place inEurope and in Asia

    24

  • 7/23/2019 Novadaq Technologies January 2016

    25/28

    3. New Product Introductions 2016

    15

    5

    Color Segmented Fluorescence Imaging

    LUNA Score Functional Imaging and AnalysisHandheld SPY Imaging

    5.0mm PINPOINT Endoscopes

    25

  • 7/23/2019 Novadaq Technologies January 2016

    26/28

    4. Outcomes Based Level I Clinical Studies

    Randomized multicenter trial of PINPOINT inColorectal Surgery (n=500-900)

    25 U.S. centers

    Recruitment on-going

    Interim results report expected at SAGES 2017

    FILM Trial PILLAR III

    Obtain FDA Indication for SLN Mapping

    A Prospective, Open Label, Multicenter Study ofPINPOINT in Gynecological Oncology (n=150)

    6-8 U.S. and Canadian Centers

    Recruitment on-going Results expected Q4-2016

    Obtain Outcomes-Based FDA Label

    Images Courtesy of Nadeem Abu-Rustum, M.D., NY,NY and Michael Stamos, M.D. Irvine, CA 26

  • 7/23/2019 Novadaq Technologies January 2016

    27/28

    5. New Imaging Molecules

    Cancerous tumor fluorescing, the normal tissue is not

    Image courtesy of Eben L. Rosenthal, MD, Stanford, CA

    27

  • 7/23/2019 Novadaq Technologies January 2016

    28/28

    Summary of Growth Drivers

    Drivers 2016 2017 2018

    1. Expanded, FocusedSales Channels

    2. International Expansion

    3. New Product Introductions

    4. Level I Clinical Studies

    FILM

    PILLAR III

    5. New Imaging Molecules

    Add 40 Sales Pros

    NVDQ Direct Team

    Clinical Trial and Results Submission to FDA

    Clinical Trial and Results Submission to FDA

    Hardware/Software

    Molecule Identified, Clinical Trial Phases I and II Phase III & NDA or PMA Submission

    28