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get Multiple Sclerosis Insight for Personalized Control
Knowledge…
May 2012 Dr. Avi Dukler, President & CEO
TASE: GLCM
Overview and business story
TASE: GLCM
Some of the information on this document may contain projections or other forward-looking statements regarding future events or the future financial performance of Glycominds Ltd. or Glycominds Inc.
We wish to caution you that these statements are only predictions and that actual events or results may differ materially.
We refer you to the documents that Glycominds files from time to time with the Israeli Securities Authorization and Tel-Aviv Stock Exchange, specifically, Glycominds’ most recent prospectus dated February 15, 2011. This document contains and identifies important factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements, including, among others, changes in the demand for Glycominds’ products; changes in economic conditions generally or technology spending in particular; changes in the competitive dynamics of Glycominds’ markets; changes in the LDT regulation; changes in the USA reimbursement system.
Glycominds assumes no obligation, and does not intend, to update these forward-looking statements.
DisclosureForward-Looking Statements
2
Highlights
Operates in a high growth market with limited competition
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22
33
44
55
A commercial stage biomarker company
Breakthrough, novel blood tests for Multiple Sclerosis and Crohn’s Disease
Operates CLIA clinical laboratory in Simi Valley, CA
Strong IP and proprietary technology platform
3TASE: GLCM
Generates revenues demonstrating a valid business model66
SPECIALTY LAB &
MULTIPLE SCLEROSIS
MARKETS
TASE: GLCM
3% of esoteric labs creates 33% of a $62 billion market
5TASE: GLCM
Double digit growth for esoteric testing
6TASE: GLCM
High Growth on Multiple Sclerosis US Market
�Almost 500,000 MS patients in the US
�18.5% growth on drug market472,000Total US MS Patients (est)
222,000 PatientsNot on
Therapy
80,000 RRMS
CIS
101,000SPMS
40,000PPMS
250,000 Treated Patients
226,000RRMS
CIS
17,000SPMS
7,000PPMS
~25,000BetaseronPatients
~63,000 AvonexPatients
~100,000 COPAXONE
Patients
~51,000 Rebif
Patients
~10,000 TysabriPatients
~25,000 Retail
Pharmacy
~60,000 Specialty Pharmacy
~15,000 Mail
Order
Sales ~$6.4B 18.5%
Jan 2011 Size Growth
7TASE: GLCM
GLYCAN BIOMARKERS FOR MSSCIENCE & TECHNOLOGY
TASE: GLCM
What Can Biomarkers Do?
Change Managed Care Efficiency and Costs
9TASE: GLCM
Potential Mechanism of ActionNon-Cellular component of BBB Basement Membrane
Contains Collagen Type IV
Ruotsalainen et al., 2005
EAE brain stained for anti-GAGA4 (70598) or its anti-Ha control
Anti-GAGA4 (green) Anti-Ha (green)
• Data looks promising, but the secondary antibody alone also produces some green staining.
• More research is currently being conducted
Laminin
Provided courtesy of V. Wee Yong, Professor, University of Calgary
• Number of glycosylated hydroxylysineresidues varies among the various collagen types.
• For instance, Type IV collagen found in basement membranes (BM) and type VI collagen found in blood vessels have large number of modifications.
10TASE: GLCM
Next Generation in Glycan Technology for Clinical Development
From Discovery to Clinical Products� Established capability to work with small volume of specimens
� Performed extensive screening to discover and validate glycan biomarkers
� Obtained robust analysis for clinical validation
� Developed design-control process for product development and production
� Delivered regulated menu of laboratory developed tests
Glycan immobilization
Screening glycan arrays array cell analysis Lab developed test
11TASE: GLCM
Issued patents is the US*8,129,128; 8,048,639; 7,906,291; 7,608,414; 7,592,150; 7,572,592 ; 7,537,900; 6,994,966; 6,972,172
* Not include patent applications and over 100 issued and granted patents outside the US
Leading a Revolution in Managed Care
2009 2010 2011 2012* 2013 2014*
12
* Estimated
TASE: GLCM
THE PRODUCTS:BLOOD TESTS FOR MS
TASE: GLCM
MRI alone can NOT be sufficient for timely diagnosis, * “No better explanation” is challenging for general neurologist
MS is still diagnosis of exclusions –
Today
Series of MRI
Spinal Tap
The Solution
“There must be no better explanation for the clinical presentation, and objective evidence must be present to support a diagnosis of MS”
Critical time is lost
Glycominds test expedites diagnosis and can double the effective window for early treatment.
14* Polman et al ANN NEUROL 2011;69:292–302
Saving $11,000 of first diagnosis year
Brettschneider et al Journal of Neuroimmunology 2009;217:95-101.
TASE: GLCM
Patient: Improve early diagnosis; eliminate unnecessary disabilities
� Value Proposition:
Value and Size of Opportunity for
Market Size:
Suspected MS
cases 100,000 p.a.
New CIS/MS patients 31,000 new cases p.a.*
$120 Million
p.a.$1,290 / gMS Dx
charged
Physician: Gain differential diagnosis; decide based on patients at risk
US Payer: Save first year of diagnosis work-up costs
� Size of the US Market for gMSDx test:
15TASE: GLCM
Glycominds as market leader will take 30-40% market share in next 5 years
The Solution
Early treatment windows, many treatment options and different efficacy/ safety profiles creates an unmet medical need for a Risk / Benefit decisions tool for
newly diagnosed and breakthrough cases
MS is heterogeneous disease, prognosis is challenging
Betaseron®
(IFNß-1b)
BG-12(Dimethyl Fumarate)
Avonex®
(IFNß-1a)
Rebif®
(IFNß-1b)
Copaxone®
(glatiramer acetate)
Extavia®
(IFNß-1b)
Tysabri®(natalizumab)
Novantrone®
(Imitoxantrone
Gilenya®
(fingolimod)
Lemtrada®
(alemtuzumab)
AubagioTM
(Teriflunomide)
Ofatumumab
Breakthrough blood test that predicts patients’ risk level for sustained disability progression
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Ocrelizumab
Daclizumab
Freedman M. et al. Multiple Sclerosis Journal , published online Dec 2011.
TASE: GLCM
Patient: Improve early diagnosis; eliminate unnecessary disabilities
� Value Proposition:
Value and Size of Opportunity for
Market Size:
80,000 p.a.
~15% p.a. out of 276,000 RRMSpatients
prior significants disabilities
31,000 new cases p.a..
$300 Million
p.a.
$3,920 / gMS EDSS charged
Physician: Gain differential diagnosis; decide based on patients at risk
US Payer: Save drug costs and gain extra QALY (Dominant in cost effectiveness model)
17TASE: GLCM
� Size of the US Market for gMSDx test:
Glycominds as market leader will take 30-40% market share in next 5 years
The Solution
Risk for severe side effects in Multiple Sclerosis is associated with suppressive immune system.
Pipeline: The Risk Management challenge
Tysabri®(natalizumab)
Novantrone®
(Imitoxantrone
Gilenya®
(fingolimod)
Campath®
(alemtuzumab)
Glycominds test may predict risk for severe side effects based on immunosupressive system
PML
Leukemia
Herpes Zoster, malignancy
Secondary Autoimmunity
18TASE: GLCM
GO TO MARKET
TASE: GLCM
Fully integrated clinical laboratory with nation-wide CLIA certifications
20TASE: GLCM
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Built an impacting marketing team in the US
TASE: GLCM
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Built an effective sales reps team in the West Coast
Sales force USA West Coast Penetration
Quarterly Reported Test in the West Coast
TASE: GLCM CONFIDENTIALYour Logo
West Coast
South West
South
North West
Great Lakes
New York
NorthEast
Central North E
Central North W
Central SouthSouth
East
2012 sales force plan
Extending sales reps in Q1-2013
Significant Growth Potential in Diagnosis of Multiple Sclerosis in the US
23TASE: GLCM
Patient Education
Patient and Caregiver Outreach Campaign
Social Networks Patient Associations
24TASE: GLCM
Patients
ProvidersPayers
Obtaining network of PPO agreements
Done in Q4-11-Q1-2012: What to Expect:
25TASE: GLCM CONFIDENTIALYour Logo
‘Flying below radar” approach with five first tier insurance plans that cover 50% of the commercial market (100 million lives) to reach critical mass, and medical policy coverage in 2013
Medical Policy Coverage Decisions with Target Healthcare Plans in 2013
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(WA)
(PA)
(CA)
(NJ)
TASE: GLCM
COMPETITION
TASE: GLCM
MRI is the main biomarker inMultiple Sclerosis
Sagittal T1-weighted MRI depicts multiple hypointense lesions in the corpus callosum; this finding is characteristic of multiple sclerosis.
Coronal fluid-attenuated inversion recovery (FLAIR) MRI in a patient with multiple sclerosis demonstrates periventricular high–signal intensity lesions, which exhibit a typical distribution for multiple sclerosis.
Axial T2-weighted MRI in a patient with multiple sclerosis demonstrates numerous white matter plaques in a callosal and pericallosal white matter distribution.
Axial diffusion-weighted MRI in a patient with multiple sclerosis shows several hyperintenselesions, a feature of inflammatory disease activity.
1628TASE: GLCM
Other blood tests for MS are evolving
1629TASE: GLCM
Differential diagnosis of NMO� NMO-IgG tests is commercially available
as a differential diagnosis of NMO from MS
� The NMO test is provided by Mayo Clinic,
ARUP and Ahtena labs
JC Virus Stratification� StratifyJCV is a companion diagnostics
tests for Tysabri (a FDA approved
monocolonal Ab for MS with a risk for PML
based on a JC virus infection
� StratifyJCV was developed by Biogen Idec
(Tysabri manufacturer ) and provides in the
US by Quest Diagnostics
BUSINESS MODEL
TASE: GLCM
Glycominds, center of excellence for Multiple Sclerosis
Proprietary Technology
Critical Unmet
Medical Need
Dominant Health
Economic
Glycominds, center of excellence for Multiple Sclerosis
High Value, Low Volume.
Huge market with very high margins
Innovative Science and Business Model Delivering Value to Patients and Shareholders
31TASE: GLCM
MANAGEMENT,HISTORY OF DELIVERY
AND MILESTONES
TASE: GLCM
Leadership Team Experienced Board of Directors
Dr. Avinoam A. Dukler, Founder, Director, President & CEO
Leading Glycominds business and strategy since inspection
Mr. Ofer Shainberg, Chief Financial Officer
LLM, CPA, MBA.
Expert in financial management in fast growing companies
Mr. Randy Ringold, General Manager CLIA labFounder and General Manger of VDxI Inc.
(acquired by IDEXX Laboratories)
Former VP at Quest Diagnostics
Mrs. Benita Elkon Baitner, Director of Sales & Marketing
RN in ICU and public health
Former Product manager at Pfizer and Abbott
Dr. Nir Dotan,
Founder, Chief Technology Officer, VP R&D
Expert in glycan technology
Founder, leading the company technology since its inception
Dr. Norman Kachuck, MD, Medical Director
Multiple Sclerosis Specialist
Former associate professor of Neurology, Keck School of Medicine of USCDirector, MS Comprehensive Care and Research Center
Mr. Hanan Gilutz, Chairman
Master degree in Management;
Former VP Marketing at Orbotech (NASDAQ:ORBK)
Former manager at McKinsey & Co.
Dr. Chen M. Even, Director
Senior VP Commercial Operations, DiaSorin Sp.a (MSE:DIA)
A leading diagnostic company Market-CAP €1.7 BILLION
Mr. Robert Taub, DirectorFounder, Former CEO of Omrix Biopharmaceutical
(acquired by J&J for $438 million) MBA INSEAD
Mr. Amir Hayek, Director
Chairman of the Israeli Import and Trade Institute
Mrs. Hila Karah, Director
CIO in Eurotrust Ltd.
Former partner in Perspective hedge fund,
Former senior analyst in Oracle hedge fund
Dr. Avinoam A. Dukler, Founder, Director, President & CEO
33TASE: GLCM
2011 was strong year. We delivered:
Raised net $7M in TASE IPO and PIPE
Built effective logistics operation and sales force in Western USA
Signed on a network of agreements with PPO, covering 50 million lives
Completed CLIA regulation and accreditation with CMS and 48 states
Extended IP portfolio via several patent issuances in the US and worldwide
Entered into a series of research collaborations to expand product awareness
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34TASE: GLCM
2012 Expected Milestones
Strengthen Our Financial Position� Close financial round
Invest in Commercial Capability� Expand US sales force� Constantly improving reimbursement payments via PPO agreements� Medical Policy coverage decision with first local healthcare insurance plan
Advance Research and Development� Announce new clinical data for the disability test to increase awareness and� Report gMS-Classifier2 results for CIS prediction to CDMS to enable acceptance� Conduct other-neurological disease clinical study to extend market potential
35TASE: GLCM
ACTIVE IVD & SPECIALTY LABS
M&A MARKET
TASE: GLCM
t
High multiples on sales (x5-10) for strategic and growth companies
Active Dx M&A Market
New players (GE, Novartis, Nestle Healthcare, Japanese PE ) acquiring US labs
Over $15 billion of Dx transactions in the last 18 months
Source: Public Announcements, Dx=Diagnostics systems and kits
18 MONTHS Dx M&A TRANSACTIONS > $100M
DATE ACQUIRER TYPE TARGET TYPE DEAL VALUE ($M)
Sep-10 LabCorp Lab Genzyme IVD 925
Oct-10 GE Healthcare Dx/Equip Clarient Lab 587
Jan-11 Novartis Pharma Genoptix Lab 470
Feb-11 Quest Diagnostics Lab Athena Lab 740
Mar-11 Quest Diagnostics Lab Celera Lab 671
May-11 Thermo Fisher Dx/Equip Phadia Lab 3,500
May-11 Nestle Food/Health Prometheus Dx-Rx/Lab 1,130
Jun-11 Qiagen Dx/Tool Iphsogen IVD 101
Jul-11 Roche (Ventana) Dx Mtm Laboratories IVD 260
Aug-11 Qiagen Dx/Tool Cellestis IVD 374
Sep-11 PerkinElmer Dx/Equip Caliper IVD 600
Oct-11 Miraca Holdings (Japan) Japanese Lab Caris Diagnostics Lab 725
May-12 Hologic Imaging/surgey Gen-Probe IVD 3,700
May-12 Agilent Technologies Dx/Tool Dako IVD 2,200
TOTAL 15,983 *
* Not including Roche $6.7 billion hostile bid to Illumina shareholders
37TASE: GLCM