Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements...
Transcript of Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements...
Forward Looking Statements
This presentation includes “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and
intentions and other statements that contain words such as “expects,” “contemplates,” “anticipates,” “plans,”
“intends,” “believes” and variations of such words or similar expressions that predict or indicate future events
or trends, or that do not relate to historical matters. These statements are based on our current beliefs or
expectations and are inherently subject to significant uncertainties and changes in circumstances, many of
which are beyond our control. There can be no assurance that our beliefs or expectations will be achieved.
Actual results may differ materially from our beliefs or expectations due to economic, business, competitive,
market, regulatory, and other factors. A full discussion of our operations and financial conditions, 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 securities regulators in the U.S. and Canada.
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Investment Highlights
1st point-of-care diagnostic platform for tears
Technology objectively diagnoses Dry Eye Disease (DED)
Safe, easy-to-use, very accurate
Large IP portfolio
FDA 510(k) approved and CLIA waived, opening the door to all U.S. optometry and ophthalmology offices
Recurring revenue model
Medicare code 83861: reimbursement $45.42/patient ($22.71/ eye)
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TearLab® Tear Collection
Breakthrough Technology
Accuracy
– < 1.5% coefficient of variation (“CV”) @ 50 nanoliters
– Glucose ≥ 5.0% CV @ 5 microliters
– Cholesterol > 4.0% CV @ 20 microliters
Safe, simple collection
– No reports of corneal or conjunctival trauma in 468 eyes TearLab™ FDA 510(k) submission
2009 Medical Design Excellence Award (“MDEA”) for in vitro diagnostics
20 µL 5 µL 50 nL
Sources: Kimberly MM et. al., Clinica Chimica Acta 364 (2006); Volles DF et. al. Pharmacotherapy 18:1 (1998)5
Intellectual Property
Large IP portfolio on tear collection
– 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 platform that has broken the nanoliter volume barrier
– Enables standard testing methodologies on this platform for many different diagnostic 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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First Test: Dry Eye Disease
Tears are a sophisticated 3-layer film, and are essential to the quality of our vision
– The front layer, produced by the meibomian glands, is oil and it keeps tears from evaporating
– The middle (aqueous) layer, produced by the lacrimal glands, gives it the thickness and uniformity to ensure a clear image
– The back layer is a polish that fills in any irregularities in the corneal surface
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4 Key Tenants of DED
1. DED is a multifactorial disease causing an unstable tear film and fluctuating vision
2. DED may be associated with: stinging, burning or scratchy sensation, redness, fatigue and/or irritation
– Severity of symptoms depends on the sensitivity of the corneal nerves and can be exacerbated by anterior segment surgery (e.g. cataract, refractive or glaucoma surgery) and/or contact lens use
– Patients with desensitized corneas may not experience these symptoms but still experience significant fluctuation in vision
3. Symptoms often confound the DED diagnosis, as similar symptoms are associated with a variety of conditions
4. High osmolarity is the hallmark physiologic marker in DED; in fact, it is included in the definition of DED in the DEWS* report
8*Report of the Diagnosis and Classification Subcommittee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-92, 2007
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 generation faces in the future. Shifting demographics in
an aging population will result in a tidal wave of dry eye problems by 2030.*
* PRWeb (June 2, 2011)
Large (and Growing) Patient Population
Survey by Harris Interactive 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 patients) found the overall incidence of hyperosmolarity amongst the study population was 48%
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TearLab: Objective & Sensitive Enough To Be Used to Both Diagnose & 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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• “The main test for dry eye is the Schirmer test
– Requires repeated examinations at up to five minutes per examination
• Unfortunately, this test misses detecting many patients with dry eyes
• Other tests should also be done before ruling out a diagnosis of dry eyes”
(http://www.uic.edu/com/eye/LearningAboutVision/EyeFacts/DryEyes.shtml)
Schirmer Test
1. Tomlinson A., McCann L., Pearce E.I. Comparison of OcuSense and Clifton Nanolitre Osmometers. IOVS ARVO Abstract, 2009
2. Report of the Diagnosis and Classification Subcommittee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-92, 2007
Current Diagnosis Paradigm
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Clinical Test Positive Predictive Value
Osmolarity1 87%
Schirmers2 31%
Tear Film Breakup Time2 25%
Staining2 31%
Meniscus Height2 33%
TearLab in the Practice
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General Practice Properly diagnose patients with ocular irritations and measure the effectiveness of DED therapies
Laser Vision Correction Identify patients with DED and guide pre- and post-surgical treatment to significantly improve refractive outcomes and reduce complaints of DED symptoms
Cataract Surgery and Premium IOLs
Improve refractive outcomes and patient satisfaction while appropriately managing expectations following surgery
Glaucoma Management Improve compliance and manage the impact of chronic preservatives used in glaucoma patients which is known to cause DED
Contact Lens Fitting and Management
Approx. 50% of contact lens users develop CLYDE (Contact lens Induced Dry Eye Disease) in 5 years
TearLab Osmolarity Market Size and Economics
Card Revenue Economics based only on U.S. Doctor Utilization
There are approximately 20,000 ophthalmologists + 30,000 optometrists in the U.S.
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Additional opportunities for TearLab in …
Refractive surgery pre- and post-operative testing
Cataract Implantable lens fittings
Clinical trials
Rest of the World
Market Potential based on U.S. (only) Doctor Access
Assuming 50,000 Doctors, seeing an average of 6 dry eye patients per day testing both eyes, assuming a $10 card cost and working 250 days per year.
$1.5 Billion market based only on routine examinations
Sales Group 2014 Compensation
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Position #Base Salary
RangeTarget
Variable Comp.Total
Comp at 100%
Regional General Manager (GM) 4 $105,000-120,000 $60,000 $165,000-185,000
Assistant Sales Manager (ASM) 5 $70,000-95,000 $45,000 $115,000-140,000
Territory Manager (TM) 35 $55,000-75,000 $60,000 $115,000-135,000Independent Sales rep and Sub reps (ISR)* 6 $0
$1,000/device+ 7% Rev. -
Implementation Specialists (IS) 12 $55,000 $30,000 $85,000 Professional Relations Coordinator (PRC) 4 $43,000 $5,000 $48,000 Regional Reimbursement Specialist 4 $50,000-70,000 10% $60,000-80,000
TOTAL 70
* Under review
U.S. Sales and Marketing Strategy
2014 Marketing Plan:
Trade shows
Focus on Key Opinion Leaders and medical marketing programs
Peer-reviewed clinical trial studies utilizing TearLab technology
Introducing practice management programs and accredited DED practice program
2014 Targeting Strategy:
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- All Grow Ophthalmologists
- Refractive & Cataract Surgeons that perform premium procedures
- Optometrists that are in a co-management environment
- All Cataract Surgeons who don’t perform premium procedures
- All General Ophthalmologists who don’t do surgery
- All Optometrists who don’t co-manage
- Retina Surgeons
- Glaucoma Specialists
- Corporate Chains
Primary
Secondary
Non-Targets
Program Options
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 Multi Unit Program
Designed to accommodate large practices (more than 5 units) that want to integrate TearLab into each of their examination lanes
There are no minimum card guarantees, but detailed analysis of patient volumes and clinic protocols provide specific volume expectations that are in line with our revenue expectations
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Installed Base
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03/31/14 06/30/2014
Active Purchased Devices 190 254
Active Devices Under Use Contracts 802 774
Active Devices Under Masters Contracts 1,462(1) 1,718(2)
Total Active Devices 2,454 2,746
Devices Not Yet Activated 224 92
Total Devices 2,678 2,838
Devices Sold Outside the U.S. 518 529
(1) 176 Masters Accounts(2) 206 Masters Accounts
Revenue / Device / Account
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19% Sequential Growth Q2-2014 Over Q1-2014
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Revenue Growth Post CLIA-Waiver
Management Team
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Elias Vamvakas, CEO and Chairman 20+ years of public company leadership focused in eye care, CEO/founder TLCVision
Seph Jensen, President and COO 17 years with Alcon leading marketing and sales both in US and Internationally
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. Operations 30+ years experience in healthcare, manufacturing & operations, Abbott Labs
Tracy Puckett, V.P. Marketing 25+ years experience, McCann-Erickson, Alimera Sciences, Novartis Ophthalmics
Bill Dumencu, CFO 25+ years experience in Eye care industry and manufacturing, TLCVision, Occulogix
Duane Morrison, V.P. Sales 25+ years of sales and management experience, TLCVision, The Technology Source
Delanu Ligu MSc., V.P. Information Technology 16+ Years of HealthCare and IT, TLC Vision, Occulogix
Paul Smith, V.P. International Markets 12 years marketing, sales and operations leadership experience with Alcon
Venkiteshwar Manoj, PhD., V.P. Medical Affairs Authored over 50 scientific abstracts, research papers and book chapters, Alcon, B&L
Summary
1st point-of-care diagnostic platform for tears
Initial test objectively diagnoses Dry Eye Disease
Safe, easy-to-use platform requiring only 50 nL of tear film
Recurring revenue model
Large IP portfolio
Medicare reimbursement $45.42/patient ($22.71/eye)
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