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Page 1: TEAR Investor Presentation (4.4) Investor Presentation (4.4).pdf · 4. High"osmolarity"is"the"hallmark"physiologic"marker"in"DED;"in"fact,"high"osmolarity" is"included"in"the"defini.on"of"DED"in"the"DEWS*report
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Forward  Looking  Statements  

 This  presenta.on  includes  “forward-­‐looking  statements”  within  the  meaning  of  the  Private  Securi.es  

Li.ga.on  Reform  Act  of  1995.  These  statements   include  but  are  not   limited  to  our  plans,  objec.ves,  

expecta.ons   and   inten.ons   and   other   statements   that   contain   words   such   as   “expects,”  

“contemplates,”   “an.cipates,”   “plans,”   “intends,”   “believes”   and   varia.ons   of   such  words   or   similar  

expressions  that  predict  or  indicate  future  events  or  trends,  or  that  do  not  relate  to  historical  maJers.  

These   statements   are   based   on   our   current   beliefs   or   expecta.ons   and   are   inherently   subject   to  

significant  uncertain.es  and  changes   in  circumstances,  many  of  which  are  beyond  our  control.  There  

can   be   no   assurance   that   our   beliefs   or   expecta.ons   will   be   achieved.   Actual   results   may   differ  

materially  from  our  beliefs  or  expecta.ons  due  to  economic,  business,  compe..ve,  market,  regulatory,  

and  other  factors.  A  full  discussion  of  our  opera.ons  and  financial  condi.ons,  including  risk  factors  that  

may  affect  our  business  and  future  prospects,  is  contained  in  our  most  recent  regulatory  filings.  For  a  

complete  account  of  our  official  corporate  documents,  you  are  encouraged  to  review  documents  filed  

with  the  securi.es  regulators  in  the  U.S.  and  Canada.    

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Investment  Highlights  

•  1st  point-­‐of-­‐care  diagnos.c  plaTorm  for  tears  

•  Technology  objec.vely  diagnoses  (DED)  Dry  Eye  Disease,  the  most  common  age  related  disease  

•  Safe,  easy-­‐to-­‐use,  very  accurate  

•  Large  IP  porTolio  

•  FDA  510(k)  approval  and  recent  CLIA  waiver  issued  on  January  24,  2012  opens  the  door  to  all  U.S.  optometry  and  ophthalmology  offices  

•  Recurring  revenue  model    

•  Na.onal  Medicare  code  83861  Reimbursement  $45.42/pa.ent  ($22.71/  eye)  

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Breakthrough  Technology  

•  Accuracy  –  <  2.33%  coefficient  of  varia.on  (“CV”)  @  50  nanoliters  –  Glucose  ≥  5.0%  CV  @  5  microliters  –  Cholesterol  >  4.0%  CV  @  20  microliters  

•  Safe,  simple  collec.on  –  No  reports  of  corneal  or  conjunc.val  trauma  in  468  eyes  

TearLab™  FDA  510(k)  submission  

•  2009  Winner  of  the  Medical  Design  Excellence  Awards  (“MDEA”)  award  for  In  Vitro  Diagnos.cs  

20  µL   5  µL   50  nL  

Sources: Kimberly MM et. al., Clinica Chimica Acta 364 (2006); Volles DF et. al. Pharmacotherapy 18:1 (1998)

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Intellectual  Property  

•  Large  IP  porTolio  on  tear  collec.on  –  9  patents  issued:  7,017,394;  7,051,569;  7,111,502;  7,129,717;  7,204,122;  

7,574,902;  7,810,380;  7,905,134;  7,987,702;  8,020,433  –  Several  pending  (around  design,  manufacturing  and  other  tests)  

•  Electrochemical  plaTorm  that  has  broken  the  nanoliter  volume  barrier  –  Enables  standard  tes.ng  methodologies  on  this  plaTorm  for  many  different  

diagnos.c  tests  for  a  variety  of  markers  –  Patents  pending  on  other  analytes  (proteins,  genes)  and  methods  to  

measure    

•  Core  claims  around  lab-­‐on-­‐a-­‐chip  in  the  U.S.  and  selected  key  countries  

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•  Tears  are  a  sophisAcated  3-­‐layer  film,  and  are  essenAal  to  the  quality  of  our  vision  –  The  front  layer,  produced  by  the  meibomian  

glands,  is  oil  and  it  keeps  tears  from  evapora.ng;  

–  Middle  (aqueous  layer),  produced  by  the  Lacrimal  glands,    gives  it  the  thickness  and  uniformity  to  ensure  a  clear  image;  and  

–  The  back  layer  is  a  polish  that  fills  in  any  irregulari.es  in  the  corneal  surface    

Introducing  the  First  Test:  Dry  Eye  Disease  

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1.  DED  is  a  mul.factorial  disease  caused  by  meibomian  gland  dysfunc.on  and/or  a  reduced  func.on  of  the  lacrimal  gland  and/or  damage  to  the  corneal  surface  causing  an  unstable  tear  film  and  fluctua.ng  vision  

2.  DED  may  be  associated  with:  s.nging,  burning  or  scratchy  sensa.on,  redness,  fa.gue  and/or  irrita.on  –  Severity  of  symptoms  depends  on  the  sensi.vity  of  the  corneal  nerves  and  can  be  

exacerbated  by  anterior  segment  surgery  (e.g.  cataract,  refrac.ve  or  glaucoma  surgery)  and/or  contact  lens  use  

–  Pa.ents  with  desensi.zed  corneas  may  not  experience  these  symptoms  but  s.ll  experience  significant  fluctua.on  in  vision  

3.  Symptoms  oten  confound  the  DED  diagnosis,  as  similar  symptoms  are  associated  with  a  variety  of  condi.ons  (e.g.  allergies,  infec.ons,  recurrent  corneal  erosion  (RCE),  conjunc.vochalasis,  epithelial  basement  membrane  dystrophy  (EBMD),  giant  papillary  conjunc.vi.s  (GPC),  asthenopia  and  many  more)  

4.  High  osmolarity  is  the  hallmark  physiologic  marker  in  DED;  in  fact,  high  osmolarity  is  included  in  the  defini.on  of  DED  in  the  DEWS*  report  

4  Key  Tenants  of  DED  

*Report of the Diagnosis and Classification Subcommittee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-92, 2007

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Large  (and  Growing)  PaAent  PopulaAon  

Dry  Eye  Syndrome  To  Become  Most  Common  Eye  Disease  in  Baby  Boomers    

Dry  eye  expert  Dr.  David  Kisling  reports  that  Dry  Eye  Syndrome  will  be  the  most  prevalent  eye  disorder  the  Baby  Boomer  genera;on  faces  in  the  future.  Shi?ing  demographics  in  an  aging  popula;on  will  result  in  a  ;dal  wave  of  dry  eye  problems  by  2030.*    

•  Survey  by  Harris  Interac.ve  on  behalf  of  Allergan,  Inc.,  found  that  nearly  

half  of  all  U.S.  adults  (48%)  experience  one  or  more  dry  eye  symptom(s)  regularly  

 •  TearLab  Osmolarity  Prevalence  Study  (8,845  paAents)  found  the  

overall  incidence  of  hyperosmolarity  amongst  the  study  populaAon  was  48%  

* PRWeb (June 2, 2011)

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TearLab  is  objecAve  and  sensiAve  enough  to  be  used  to    Both  diagnose  and  manage  DED

Testing both eyes: the higher of the two osmolarity findings helps determine severity of DED based on a linear Osmolarity Severity Scale

Inter-eye difference (> 8 mOsml/L) confirms instability of the tear film and is an important factor helping confirm a DED diagnosis Normal patients almost never have more than 4-5 mOsml/L difference between eyes

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Current  Diagnosis  Paradigm  

•  “The  main  test  for  dry  eye  is  the  Schirmer  test  

–  Requires  repeated  examina.ons  at  up  to  five  minutes  per  examina.on  

•  Unfortunately,  this  test  misses  detecAng  many  paAents  with  dry  eyes  

•  Other  tests  should  also  be  done  before  ruling  out  a  diagnosis  of  dry  eyes”  

(hJp://www.uic.edu/com/eye/LearningAboutVision/EyeFacts/DryEyes.shtml)  Schirmer  Test

1. Report of the Diagnosis and Classification Subcommittee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-92, 2007

2. Tomlinson A., McCann L., Pearce E.I. Comparison of OcuSense and Clifton Nanolitre Osmometers. IOVS ARVO Abstract, 2009

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TearLab  in  the  PracAce  

General  PracAce  –  Properly  diagnose  pa.ents  with  ocular  irrita.ons  and    measure  the  effec.veness  of  DED  therapies  

Laser  Vision  CorrecAon  –  Iden.fy  pa.ents  with  DED  and  guide  pre-­‐  and  post-­‐surgical  treatment  to  significantly  improve  refrac.ve  outcomes  and  reduce  complaints  of  dry  eye  symptoms  

Cataract  Surgery  and  Premium  IOLs  –  Improve  refrac.ve  outcomes  and  pa.ent  sa.sfac.on  while  appropriately  managing  expecta.ons  following  surgery  

Glaucoma  Management  –  Improve  compliance  and  manage  the  impact  of  chronic  preserva.ves  used  in  glaucoma  pa.ents  which  is  known  to  cause  DED  

Contact  Lens  FiWng  and  Management  –    Approx.  50%  of  contact  lens  users  develop  CLYDE  (Contact  lens  Induced  Dry  Eye  Disease)  in  5  years  

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 TearLab®  Osmolarity  Market    

Size  and  Economics  

Card  Revenue  Economics  based  only  on  U.S.  Doctor  UAlizaAon  

There  are  approximately  20,000  ophthalmologists  +  30,000  optometrists  in  the  U.S.    Market  PotenAal  based  on  U.S.  (only)  Doctor  Access  Assuming  50,000  Doctors,  seeing  an  average  of  6  dry  eye  paAents  per  day  tesAng  both  eyes,  assuming  a  $10  card  cost  and  working  250  days  per  year.  

$1.5  Billion  market  based  only  on  rouAne  examinaAons  

AddiAonal  opportuniAes  for  TearLab  in  …    • Refrac.ve  surgery  pre-­‐  and  post-­‐opera.ve  tes.ng  • Cataract  Implantable  lens  fi{ngs  

• Clinical  trials  

• Rest  of  the  World  

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U.S.  Sales  Strategy  Direct  sales  in  the  U.S.  with  4  regions  and  40  territories  61  members  currently  in  our  sales  group    •  1  VP  •  4  GMs  overseeing  the  Regions  

•  5  Professional  Rela.ons  Coordinators  •  10  Implementa.on  Specialists  •  32  dedicated  TearLab  Territory  Managers  •  9  independent  sales  reps  and  sub  reps  

 

MarkeAng  Strategy  •  Trade  shows  •  Focus  on  Key  Opinion  Leaders  and  Medical  marke.ng  programs  •  Peer-­‐reviewed  clinical  trial  studies  u.lizing  TearLab  technology  

•  Clinical  trials  with  Big  Pharma  •  Introducing  Prac.ce  Management  programs  and  Accredited  DED  prac.ce  program  

U.S.  Sales  and  MarkeAng  Strategy  

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1.  Purchase  Purchase  the  System  for  $9,500  with  no  minimum  card  commitment    

2.  USE  Agreements  Free  use  of  the  system  with  a  minimum  3  year  commitment  to  purchase  cards  

•  1,500  cards  per  year  at  $12.50  per  card  •  2,400  cards  per  year  at  $10  per  card    

3.  MASTERS  MulA  Unit  Program  Designed  to  accommodate  large  prac.ces  (more  than  5  units)  that  want  to  integrate  TearLab  into    each  of  their  examina.on  lanes  

There  are  no  minimum  card  guarantees,  but  detailed  analysis  of  pa.ent  volumes  and  clinic  protocols  provide  specific  volume  expecta.ons  that  are  in  line  with  our  revenue  expecta.ons  

Program  OpAons  

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Installed  Base  

06/30/13   09/30/13  

Ac.ve  Purchased  Devices   238   235  

Ac.ve  Devices  Under  Use  Contracts   701   825  

Ac.ve  Devices  Under  Masters  Contracts      417   800(1)  

Total  AcAve  Devices   1,356   1,860  

Devices  Not  Yet  Ac.vated   298   233  

Total  Devices     1,654   2,093  

Devices  with  Educa.onal  Ins.tu.ons/Research   44   75 Devices  Sold  Outside  the  U.S.   460   467

(1)  150 Masters accounts

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Management  Team  Elias  Vamvakas,  CEO  and  Chairman  of  the  Board  20+  years  of  public  company  leadership  focused  in  eye  care  (CEO/founder  TLCVision)  

Benjamin  Sullivan,  Ph.D.,  CSO  Harvard  Medical  School,  University  of  California  San  Diego  

Michael  Lemp,  M.D.,  F.A.C.S.,  CMO  Clinical  Professor  of  Ophthalmology,  Georgetown  &  George  Washington  University  

David  Eldridge,  OD,  F.A.A.O.,  V.P.  Clinical  and  Professional  Development  Adjunct  professor,  NSUCO,  EVP  TLC  Vision,  Occulogix  

Michael  Berg,  V.P.  Clinical  &  Regulatory  25+  years  experience  in  CLIA  waived  IVD,  Hemocue  

Steve  Zmina,  V.P.  Manufacturing  25+  years  experience,  developed  over  100  products,  Thermoscan,  Tandy  

Bob  Walder,  P.A.-­‐C.,  V.P.  OperaAons  30+  years  experience  in  healthcare,  manufacturing  &  opera.ons,  AbboJ  Labs  

Tracy  Puckei,  V.P.  MarkeAng  25+  years  experience  in  healthcare  marke.ng,  McCann-­‐Erickson,  Alimera  Sciences,  Novar.s  Ophthalmics    

Bill  Dumencu,  CFO  25+  years  experience  in  Eye  care  industry  and  manufacturing,  TLCVision,  Occulogix  

Duane  Morrison,  V.P.  Sales  25+  years  of  Sales,  Business  Development  and  Management  experience,  TLCVision,  The  Technology  Source.  

Delanu  Ligu  MSc.,  V.P.  InformaAon  Technology  16+  Years  of  HealthCare  and  IT,  TLC  Vision,  Occulogix  

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Chief Science Officer

http://execrank.com/?s=tearlab&x=0&y=0

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Surgical  Leadership  Group  •  Eric  Donnenfeld,  MD,  FACS  -­‐  Founding  Partner  of  Ophthalmic  Consultants  of  Long  Island,  President  

American  Academy  of  Cataract  and  Refrac.ve  Surgeons.  Editor  and  Chief  Cataract  and  Refrac;ve  Surgery  Today.    

•  Marguerite  McDonald,  MD,  FACS,  OCLI  -­‐  Clinical  Professor  of  Ophthalmology  at  NY  University  and  Adjunct  Clinical  Professor  of  Ophthalmology  at  Tulane  Medical  School,  Staff  Physician  ManhaJan  Eye  and  Ear,  Island  Eye  Surgicenter  and  Mercy  Medical  Center.    Past  President  of  ASCRS,  President  of  the  Int’l  Society  of  Refrac.ve  Surgery  and  President  of  the  Int’l  Society  for  Contact  Lens  Research.  

•  Terrence  O’Brien,  MD  -­‐  Bascom  Palmer  Eye  Inst.,  Asst.  Editor-­‐in-­‐Chief  Journal  of  Refrac;ve  Surgery.    

•  David  Shcanzlin,  MD  -­‐  Gordon  Weiss  &    Schanzlin  Vision  Ins.tute.  Past  Professor  and  Director  Shiley  Eye  Center,  USCD  Dept.  of  Ophthalmology.  Past  Professor  and  Chairman  St.  Louis  University,  Dept.  of  Ophthalmology.    

•  John  Sheppard,  MD  -­‐  President  of  Virginia  Eye  Associates,  Ophthalmology  Research  Program  Director,  Eastern  Virginia  Medical  School  and  Clinical  Director  Thomas  R.  Lee  Center  of  Ocular  Pharmacology.    Medical  Examiner  for  the  American  Board  of  Ophthalmology.  

•  Christopher  Starr,  MD,  FACS  -­‐  Assoc.  Professor,  Director  of  Ophthalmic  Educa.on,  Director  of  the  Cornea,  Cataract  Surgery  Fellowship  and  Director  of  Refrac.ve  Surgery  Service,  Weill  Cornell  Medical  College.    Editor  Refrac;ve  Eyecare,  Advanced  Ocular  Care,  Cataract  Refrac;ve  Surgery  Today,  Current  Ophthalmology  Reports.  Host  Eyetube  Journal  Club  and  Ocular  Surface  Series.  

•  R.  Doyle  StulAng,  MD,  PhD  -­‐  Director  Stul.ng  Research  Center,  Woolfon  Eye  Inst.    Past  President  of  ASCRS.  Past  Editor  &  Chief  Cornea.  

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Clinical  Leadership  Group  •  Charles  Aldridge,  Jr.  OD,  FAAO  -­‐  Founder  of  Aldridge  Eye  Ins.tute.  Founder  of  The  Dry  Eye  Center  of  

the  Carolinas.    •  Marc  R.  Bloomenstein,  OD,  FAAO  -­‐  Director  of  Optometric  Services  at  the  Schwartz  Laser  Eye  Center,  

President  and    founding  member  of  the  Optometric  Council  on  Refrac.ve  Technology.  Member  of  the  ASCRS  Integrated  Eye  Care  Delivery  Task  Force.  Adjunct  Assistant  Professor  at  the  Southern  California  College  of  Optometry  and  Arizona  College  of  Optometry.  

•  Douglas  K.Devries,  OD,  FAAO  -­‐  Co-­‐founder  and  managing  partner  of  Eye  Care  Associates  of  Nevada.  Past  President  of  the  Nevada  Optometric  Associa.on  and  the  Great  Western  Council  of  Optometry  (GWCO).  

•  David  I.  Geffen,  OD,  FAAO  -­‐  Weiss  Schanzlin  Vision  Ins.tute.  Contribu.ng  Editor  Optometry  Times.  •  Paul  Karpecki,  OD,  FAAO  -­‐  Director  of  Ocular  Disease  Research,  Koffler  Vision  Group,  Chair  of  the  

Refrac.ve  Surgery  Advisory  CommiJee  to  the  AOA.  TearLab  Board  Member.    •  Jerry  Nolfi,  OD,  MBA  -­‐  Prac.cing  optometrist.    Has  served  as  a  clinical  and  strategic  consultant  to  

Johnson  &  Johnson  Vision  Care,  Alcon,  Allergan,  AMO  and  TLC  Laser  Eye  Centres.  •  Jim  Owen,  OD,  FAAO,  MBA  -­‐  Optometric  Director  for  Coronado  Eye  Associates.  •  James  Thimmons,  OD,  FAAO  -­‐  Co-­‐founder  of  Ophthalmic  Consultants  of  Connec.cut.    •  William  Townsend,  OD,  FAAO  -­‐  Dis.nguished  Visi.ng  Clinician  in  Residence  at  the  University  of  

Houston  College  of  Optometry,  adjunct  professor.    •  Walter  Whitley,  OD,  FAAO  -­‐  Virginia  Eye  Associates.  Dr.  Whitley  serves  on  the  Board  of  Trustees  for  

the  Virginia  Optometric  Associa.on  and  was  recently  recognized  as  the  VOA  2012  Young  Optometrist  of  the  Year.  VOA  2012  Young  Optometrist  of  the  Year.      

•  Derek  Cunningham,  OD,  FAAO  -­‐  Director  of  Optometry  at  Dell  Laser  Consultants.  

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•  Michael  Lemp,  MD,  FACS  -­‐  Clinical  Professor  of  Ophthalmology,  Georgetown  Univ.  and  George  Washington  Univ.,  CMO  TearLab  Corp.  

•  Christophe  Baudouin,  MD,  PhD  -­‐  Dept.  Head  Ophthalmology  Univ.  of  Versailles,  Dept.  Head  of  Quize-­‐Vingts  Na.onal  Ophthalmoloy  Hospital,  Paris,  President  of  the  Ophthalmology  Society  Paris,  Editor  in  Chief  French  Journal  of  Ophthalmology.  

•  Anthony  Bron,  FRCS  -­‐  Dept.  Head  Nuffield  Laboratory  of  Ophthalmology,  Oxford,  England.  Past  President  Ophthalmic  Sec.on  of  the  Royal  Society  of  Medicine,  London.  

•  Gary  Foulks,  MD,  FACS  -­‐  Arthur  and  Virginia  Keeney  Chair  at  University  of  Louisville  School  of  Medicine.  Director  of  Cornea  Service  and  Medical  Director,  Contact  Lens  Service.  

•  Kelly  Nichols,  OD,  MPH,  PhD,  FAAO,  Dipl  PH  -­‐  Associate  Professor  Ohio  State  University  College  of  Optometry.  

•  Jay  S.  Pepose,  M.D.,  Ph.D.  -­‐    Professor  of  Clinical  Ophthalmology  at  Washington  University  School  of  Medicine.  

•  Alan  Tomlinson,  MSc,  PhD,  FC  Optom,  CCLP,  D  Orth,  FAAO  -­‐  Prof.  Vision  Sciences  Glasgow,  Caledonian  University.    

•  Gerd  Geerling,  MD  -­‐  Professor  Doctor  University  of  Dusseldorf  Moorfields  Hospital  trained  ophthalmic  surgeon.  

Academic  Research  Group  

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Summary  

•  1st  point-­‐of-­‐care  diagnos.c  plaTorm  for  tears  

•  Ini.al  test  objec.vely  diagnoses  Dry  Eye  Disease  

•  Safe,  easy-­‐to-­‐use  plaTorm  requiring  only  50  nL  of  tear  film  

•  Recurring  revenue  model  

•  Large  IP  porTolio    

•  Medicare  reimbursement  $45.42/pa.ent  ($22.71/eye)