tear investor presentation (4.4) investor presentation (4.4).pdf · 4....
TRANSCRIPT
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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)