tear investor presentation (6.8) › pdfs › tear_investor_presentation... · 2014-11-14 ·...
TRANSCRIPT
·∙ 1
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 maIers. 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.
2
TearLab® Who We Are
We believe in accomplishing what has not yet been done
We pioneer breakthroughs in technology that help doctors do what they do beIer
Our innova.on has, for the first .me, enabled quan.ta.ve analysis of tear film biomarkers at the point-‐of-‐care
Investment Highlights
• 1st and only nanoliter point-‐of-‐care diagnos.c plaUorm
• Only point of care technology that can measure Osmolarity
• Safe, easy-‐to-‐use, extremely accurate
• Large IP porUolio
• FDA 510(k) approved and CLIA waived, opening the door to all U.S. optometry and ophthalmology offices
• Recurring revenue model
• Medicare reimbursed, code 83861: $45.08/pa.ent ($22.54/ eye)
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The Technology
Breakthrough Accuracy • Accuracy
– < 1.5% coefficient of variaHon (“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 Medical Design Excellence Award (“MDEA”) 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) 6
Broad Intellectual Property
• Large IP porUolio 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 plaUorm that has broken the nanoliter volume barrier – Only plaUorm in the world that works with nanoliter volume samples – Enables standard tes.ng methodologies on this plaUorm 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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Our First Test
Tear Film ComposiHon
Tears are a sophis.cated 3-‐layer film, and are essen.al to the quality of our vision
– The front layer, produced by the meibomian glands, is oil and it keeps tears from evapora.ng
– 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 irregulari.es in the corneal surface
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A Vital Sign to Eye Health
Knowing a paHents Osmolarity is criHcal to the health of their cornea
Hyperosmolarity is known to cause:
– damage to the Ocular surface and cell death – unstable tear film and fluctua.ng Vision – Inflamma.on
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Osmolarity TesHng
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1. TearLab is the only way to test for Osmolarity at the point-‐of-‐care
2. The variability in Osmolarity readings between the two eyes can iden.fy instability in the Tear film in real .me
3. Our Osmolarity test can be used to both categorize disease severity and manage therapy
Clinical Value ProposiHon
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General PracHce
Properly diagnose pa.ents with ocular irrita.ons and measure the effec.veness of DED therapies
Cataract & RefracHve Surgery
Iden.fy pa.ents with hyperosmolarity and guide pre-‐surgical planning and post-‐surgical treatment to improve refrac.ve outcomes and reduce DED symptoms
Contact Lens Fi\ng and Management
Approx. 50% of contact lens users develop CLIDE (Contact Lens Induced Dry Eye Disease) in 5 years
Hyperosmolarity undermines a doctor’s ability to provide good visual outcomes
Hyperosmolarity is Recognized as the Central PathogeneHc Mechanism of Dry Eye Disease (DED)
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*Report of the Diagnosis and Classifica.on SubcommiIee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-‐92, 2007
- Systemic auto immune Disease (Inflammation) - Androgen deficiency - Contact lens use - Surgery/ Ocular Damage - Medication side effect - Environmental stress
Dry Eye Disease As defined and characterized by: 1. Meibomian gland dysfunction 2. Lacrimal Gland dysfunction 3. Breakdown of Neuro-pathways 4. Ocular surface dysfunction (Mucin)
RESULTS IN: High Osmolarity and an Unstable Tear-Film*
Causes 1. Damage to the Ocular surface
(irregular) 2. Inflammation 3. Fluctuating Vision
• “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 detec.ng many pa.ents with dry eyes
• Other tests should also be done before ruling out a diagnosis of dry eyes”
(hIp://www.uic.edu/com/eye/LearningAboutVision/EyeFacts/DryEyes.shtml)
Schirmer Test
1. Tomlinson A., McCann L., Pearce E.I. Comparison of OcuSense and Cliton Nanolitre Osmometers. IOVS ARVO Abstract, 2009 2. Report of the Diagnosis and Classifica.on SubcommiIee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-‐92, 2007
Current Diagnosis Paradigm
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Clinical Test PosiHve PredicHve Value
Osmolarity1 87%
Schirmers2 31%
Tear Film Breakup Time2 25%
Staining2 31%
Meniscus Height2 33%
Hyperosmolarity and FluctuaHng Vision
Stable Vision is CriHcal in performing
– Cataract Surgery – Refrac.ve Surgery – Contact Lens Fiwngs
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Nochez Y, et al. Evaluation of tear film quality with a double-pass scattering index. ARVO E-Abstract 3754, 2011.
Understanding Tear Instability
·∙ 16
65%-70% of the total refractive power of the eye occurs at the air-tear film interface*
*Nochez Y, et al. Evaluation of tear film quality with a double-pass scattering index. ARVO E-Abstract 3754, 2011.
Effect of Hyperosmolarity on Cataract Readings
Only hyperosmolar subjects showed large deviaHons in K1 Axis between visits
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Effect of Osmolarity on RefracHve Surgery
Protocol for Cataract and RefracHve Surgery (Sample)
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TEARLAB ALL PaHents Going to Surgery
NORMAL MILD MODERATE SEVERE
Proceed with Surgery
Proceed with Surgery Check and make sure there is good lubrica.on for an extended period post-‐surgery
TREAT to Stabilize
Proceed with Surgery
Manage Disease
SUBTYPE
-‐ Exam -‐ Stain -‐ Schirmers -‐ TBUT -‐ MMP9 -‐ LipiView
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The Opportunity
Understanding Market Metrics
Ophthalmologists: • On average an Ophthalmologist sees 35 pa.ents/day • They spend approximately 153 days in their clinic • Assuming they only test pa.ents that complain of DED symptoms (42%), they will
perform 3,374 tests annually • On average they will use 3 examina.on lanes and, if they have a device in each
lane, are expected to do 1,125 tests per device
• Above translates into annual revenue of approximately $11,000 per device
Optometrists: • On average an Ophthalmologist sees 18 pa.ents/day • They spend approximately 205 days in their clinic • Assuming they only test pa.ents that complain of dry eye symptoms (42%), they
will perform 2,790 tests annually • On average they will use 2 examina.on lanes and, if they have a device in each
lane, are expected to do 1,395 tests per device • Above translates into annual revenue of approximately $14,000 per device
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Market Opportunity
• There are 17,000 Ophthalmologists in the U.S., of which 15,000 are ac.vely engaged in prac.ce
• There are 38,000 Optometrists in the U.S., of which 34,000 are ac.vely engaged in prac.ce
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Market PotenHal Based on using TearLab in a clinic (U.S. Only) 15,000 X $33,740 = $506 Million in poten.al revenue from MDs 34,000 X $27,900 = $949 Million in poten.al revenue from ODs
Total Revenue PotenHal = $1.5 Billion
Market PenetraHon – Doctor Analysis
Have access to device 3,552
Current Target 28,000
Total Market 49,000
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100%
57%
13%
Market PenetraHon – Dollar Analysis
Revenue, running 4 quarters $18.8M
Have access to device $113M
TearLab Target $847M
Total Market $1.5B
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100%
56%
13%
17%
Commercial Team
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President and COO Seph Jensen
(November 2013) (ALCON)
Marke.ng Julie Speed
(November 2014) (ALCON)
Sales Duane Morrison
(2009) (TLCVISION)
Interna.onal Paul Smith (June 2014) (ALCON)
IT/Customer Service Delano Ligu (January 2014) (TLCVISION)
Medical Affairs Manoj V.
(October 2014) (ALCON)
Sales Reps 41 reps,
6 Managers 11 Implementa.on
Corporate Training Scoj Aho
(September 2014)
Sales Analy.cs David Morrison
(July 2014)
Reimbursement Support
Mike Berg (December 2013)
3 Managers (ALCON)
Go to Market Strategy 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 MulH Unit Program Designed to accommodate large prac.ces (more than 5 units)
No minimum card guarantees, but specific volume expecta.ons in line with our revenue expecta.ons
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In Q3-‐2014, introduced a new Use Agreement that consolidates all of the above, simplifying the program while maintaining all exisHng business aspects
New Flex Agreement
Installed Base
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06/30/2014 09/30/2014
Ac.ve Purchased Devices 254 256
Ac.ve Devices Under Use Contracts 774 810
Ac.ve Devices Under Masters Contracts 1,718(1) 1,763(2)
Total AcHve Devices 2,746 2,829
Devices Not Yet Ac.vated 92 82
Total Devices 2,838 2,911
Devices Sold Outside the U.S. 518 558
(1) 206 Masters Accounts (2) 252 Masters Accounts
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Revenue Growth Post CLIA-‐Waiver
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2012 2013 2014
Total Reven
ue (‘000s)