tear investor presentation (6.1)6.1).pdf · tear investor presentation (6.1).ppt author: stephen...
TRANSCRIPT
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 maHers. 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
Investment Highlights
! 1st point-‐of-‐care diagnos,c plaQorm for tears
! Technology objec,vely diagnoses Dry Eye Disease (DED)
! Safe, easy-‐to-‐use, very accurate
! Large IP porQolio
! 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/pa,ent ($22.71/ eye)
3
4
TearLab® Tear Collec<on
Breakthrough Technology ! Accuracy
– < 1.5% 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 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) 5
Intellectual Property
! Large IP porQolio 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 plaQorm that has broken the nanoliter volume barrier – Enables standard tes,ng methodologies on this plaQorm 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
6
First Test: Dry Eye Disease
! 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
7
Understanding Dry Eye Disease
8
*Report of the Diagnosis and Classifica,on SubcommiHee 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
DED 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”
(hHp://www.uic.edu/com/eye/LearningAboutVision/EyeFacts/DryEyes.shtml) Schirmer Test
1. Tomlinson A., McCann L., Pearce E.I. Comparison of OcuSense and Cliron Nanolitre Osmometers. IOVS ARVO Abstract, 2009 2. Report of the Diagnosis and Classifica,on SubcommiHee of the Dry Eye Workshop (DEWS).” The Ocular Surface 5(2): 75-‐92, 2007
Current Diagnosis Paradigm
9
Clinical Test Posi<ve Predic<ve Value
Osmolarity1 87%
Schirmers2 31%
Tear Film Breakup Time2 25%
Staining2 31%
Meniscus Height2 33%
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.*
* PRWeb (June 2, 2011)
Large (and Growing) Pa<ent Popula<on
! 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 pa,ents) found the overall incidence of hyperosmolarity amongst the study popula,on was 48%
10
TearLab in the Prac<ce
11
General Prac<ce
Properly diagnose pa,ents with ocular irrita,ons and measure the effec,veness of DED therapies
Laser Vision Correc<on
Iden,fy pa,ents with DED and guide pre-‐ and post-‐surgical treatment to significantly improve refrac,ve outcomes and reduce complaints of DED 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 FiQng and Management
Approx. 50% of contact lens users develop CLYDE (Contact lens Induced Dry Eye Disease) in 5 years
Protocol for Cataract and Refrac<ve Surgery (Sample)
12
TEARLAB ALL Pa<ents 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
TearLab Osmolarity Market Size and Economics ! Card Revenue Economics based only on U.S. Doctor U,liza,on
! There are approximately 20,000 ophthalmologists + 30,000 optometrists in the U.S.
13
Addi<onal opportuni<es for TearLab in …
! Refrac,ve surgery pre-‐ and post-‐opera,ve tes,ng
! Cataract Implantable lens fiyngs
! Clinical trials
! Rest of the World
Market Poten<al based on U.S. (only) Doctor Access
Assuming 50,000 Doctors, seeing an average of 6 dry eye pa<ents per day tes<ng both eyes, assuming a $10 card cost and working 250 days per year.
$1.5 Billion market based only on rou<ne examina<ons
U.S. Sales and Marke<ng Strategy
Marke<ng Strategy:
To Build our Osmolarity test as an essen,al ocular health indicator
Marke<ng Plan: ! Trade shows ! Focus on Key Opinion Leaders and medical marke,ng programs ! Peer-‐reviewed clinical trial studies u,lizing TearLab technology ! Introducing prac,ce management programs and accredited DED prac,ce
program
Program Op<ons 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 Mul< 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 specific volume expecta,ons in line with our revenue expecta,ons
15
TearLab will be introducing a new Use Agreement that will consolidate all of the above, simplifying the program while maintaining all exis<ng business aspects
Details of program will be announced at our Analyst & Investor Day next week
Installed Base
16
03/31/14 06/30/2014
Ac,ve Purchased Devices 190 254
Ac,ve Devices Under Use Contracts 802 774
Ac,ve Devices Under Masters Contracts 1,462(1) 1,718(2)
Total Ac<ve Devices 2,454 2,746
Devices Not Yet Ac,vated 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
17
19% Sequen<al Growth Q2-‐2014 Over Q1-‐2014
18
Revenue Growth Post CLIA-‐Waiver
2014: A Year of Growth
19
1. Sales Organiza<on: ! Added 23 people to our sales organiza,on ! Established a reimbursement support team ! Created a corporate training and sales analy,cs func,on
Current team consists of: 37 Territory Mangers, 6 Area Managers, 11 Implementa,on Specialists, 4 Reimbursement Analysts, 4 Sales Opera,ons Coordinators, 1 person in Training and Analy,cs, 2 Regional Directors, 1 Director of Sales Opera,ons and 1 VP Sales
2. Marke<ng Group (New Messaging and Campaign): ! Create segmenta,on analysis ! Reposi,on Brand: an essen,al measure of ocular health ! Support many studies and publish peer-‐reviewed ar,cles suppor,ng brand
3. Management Team (3 VP and 1 Director Level Hires): ! Paul Smith for global market development (to discuss in more detail on Analyst & Investor
Day) ! Venkiteshwar Manoj to improve medical affairs strategy & output ! Delano Ligu to build our IT infrastructure and our opera,ons backbone ! Lynne PraH to raise level of performance and value add from HR func,on
4. R&D: ! Completed research of new panel of tests and moved into the development phase (to discuss
with more detail on Analyst & Investor Day)
Summary
! 1st point-‐of-‐care diagnos,c plaQorm for tears
! Ini,al test objec,vely diagnoses Dry Eye Disease
! Safe, easy-‐to-‐use plaQorm requiring only 50 nL of tear film
! Recurring revenue model
! Large IP porQolio
! Medicare reimbursement $45.42/pa,ent ($22.71/eye)
20