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Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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Page 1: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of
Page 2: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 3: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 4: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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TearLab® Tear Collection

Page 5: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 6: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 7: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 8: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 9: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 10: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 11: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

• “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%

Page 12: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 13: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 14: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 15: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 16: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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Page 17: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 18: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

Revenue / Device / Account

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Page 19: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

19% Sequential Growth Q2-2014 Over Q1-2014

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Revenue Growth Post CLIA-Waiver

Page 20: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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

Page 21: Forward Looking Statements - TearLab Investor Presentation (5.0).pdf · Forward Looking Statements This presentation includes “forward-looking statements”within the meaning of

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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