NexGen Life Science Conference NexGen Life Science Conference
NexGen Life Science ConferenceNexGen Life Science Conference
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ff fwill be realized and actual results in each case could differ materially from those currently anticipated in such statements.
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BioLight Presenting a New Approach to Creating Value in Biomed
BioLight directly invests in, manages and commercializes biomedical innovations that
g g pp g
are grouped in "clusters" around defined medical conditions that break down silos
and that are conducive to accelerated innovation
Our two existing clusters focus on:
• Cancer diagnostics, through our 29%
ownership of Micromedic (TASE: MCTC)
• Ophthalmology, through our 100%
owned subsidiary XL Vision
By implementing our unique approach better risk / return
dynamics are created via economies of scale and best practices dynamics are created via economies of scale and best practices
acceleration
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BioLight Corporate Snapshotg p p
Traded on Tel‐Aviv Stock Exchange (TASE: BOLT)
Backed by investors with significant biopharmaceutical experience including:
• Israel Makov (20% stake), the former President & CEO of Teva Pharmaceuticals, ( ), ,which is now the 12th largest global pharmaceutical company1
• Dilip Shanghvi (22% stake), the founder and managing director of Sun Pharma, d ’ l h l b kIndia’s largest pharmaceutical company by market cap2
• Dan Oren, (13% stake) is the founder, President & CEO of Dexcel Pharma, the 2nd
largest pharmaceutical manufacturer in Israel3largest pharmaceutical manufacturer in Israel
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1. Source : ‘current partnering 2013’ 2012 revenue base2. Source: Crisil Ratings 3. Source : IATI, Israel Advanced Technoloy Industries
Investment Highlights
• World‐class management team with track record of industry success and
g g
significant board ownership
• Each cluster (XL Vision and Micromedic) has multiple opportunities targeting ( ) p pp g gunmet needs in sizable markets
• Clear strategy to regulatory approval and beginning commercialization on lead gy g y pp g gopportunities in 2014
• Numerous value creating milestones over next 12‐24 monthsNumerous value creating milestones over next 12 24 months
• Attractive valuation relative to peer U.S. companies in ophthalmology
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Extensive Management Expertiseg p
Israel MakovBioLight Chairman of the Board
Former President & CEO of Teva Pharmaceuticals ‐ world’s leader in the generic industry & now top 12‐global pharma During Makov’s five year tenure as CEO, Teva’s sales increased 4X and net income increased ≈6X Led Teva through an aggressive M&A strategy, including: Biogal (1995), Novopharm (1999), Sicor (2004), IVAX (2006) Chairman of Sun Pharmaceuticals, Given Imaging (Nasdaq: GIVN) and Micromedic Technologies (TASE: MCTC)
Suzana Nahum‐ZilberbergCEO BioLight
Over 15 years of experience in the BioMed industry Over 15 years of experience in the BioMed industry Former VP for Asia and Pacific of Teva Pharmaceutical, lead the penetration of Teva into Japan and China, through JV
agreement with Kowa Pharmaceutical (2008) and the acquisition of Taisho Pharmaceutical (2009) which resulted in Tevabecoming the fifth largest generic company in Japan.
Chairman of BioMarCare, Vice Chairman of Micromedic Technologies (TASE: MCTC)
Itai Bar‐NatanCFO BioLight
Prior to serving as CFO of BioLight and its subsidiaries, worked for Ernst & Young for 10 years in both U.S. and Israel Breadth of experience in corporate finance, international corporate tax, fund raising for early stage clients , M&As,
IPOs and secondary capital raising.
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How Our Cluster Approach Benefits Investors…
Leverage knowledge of a
pp
Synergies come from shared specific medical condition
across different approaches and the
protocol of treatment (
from shared resources, executive talent, exposure to KOLs and access to strategic partners(diagnostics, treatment,
devices, etc.)Project 6
Project 1
Project 2
strategic partners
Each company can
Project 5 Project 3
Project 4Each company can utilize individual
approach in commercial efforts, partnering and fund
Single investment provides access to a portfolio of products
l i l partnering and fund raising
across multiple therapeutic areas
Each company has dedicated team of
researchers resulting in separate IP
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lOur Glaucoma and Dry Eye S ndrome Cl sterSyndrome Cluster
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XLVision Products
IOPtiMateTM Eye‐DTMTeaRxTM IOPtiMate Eye DTeaRx
Long term controlled released drug delivery technology
A Dry‐Eye diagnostic test
Laser based treatment of Glaucoma surgery
drug delivery technology
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TeaRxTM ‐ Diagnostic for Dry Eye Syndrome g y y y
• Dry Eye is a multi parameter syndrome
• TeaRxTM is a superior diagnostics tools to detect, treat and monitor dry‐eye
• Few tests are currently available measuring single parameter related to dry
eye (Schirmer, TearLab )
• Assessment of multiple parameters allows improved treatment
Major advantages:
• Cheap & easy (small paper placed under lower eyelid)
• Executed by any health care professional (not necessarily physician)
• Easy reading, multiple parameters (color indication) vs. existing methods
(e pensi e & limited)(expensive & limited)
• No electrical device required
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TeaRxTM A $70 Million Business Opportunitypp y
• More than 100 million patients worldwide 20 30 million • More than 100 million patients worldwide, ~20‐30 million
in the US alone
• Stick used for both diagnostics screening and • Stick used for both diagnostics, screening and
monitoring
• Price per stick is estimated at $8 $12• Price per stick is estimated at $8‐$12
• No device/capital equipment required
• 3‐7% market share globally within 5 years from launch
• Reaching sales peak of $70 million worldwide
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TearRx™ Path of Value Creating Events g
2014 2015 2016 2017
TeaRxTM Clinical TrialsFDA Approval and Industrialization Commercialization Commercialization
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The IOPtiMateTM Technology
Laser‐assisted surgical device that enables eye surgeons performing an accurate
Deep Sclerectomy Glaucoma Surgery to reduce the elevated IOP by thinning
gy
the Sclera of the eye without penetrating into the eyeball
Key Advantages
Safe, minimally invasive laser procedure
Significant long‐term reduction of IOP
Low post‐operation complication rate
One‐time procedure reduces the need for medications
Broad IP protection Broad IP protection
Simple to perform with short learning curve
Flexible business model that fits both private & public hospitals
CE, Mexico and Israeli approvals and SFDA approval expected by Q1
2014 – begin revenue generation in 2014
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IOPtiMateTM ‐ $60 Million Business Opportunitypp y
• ~70M patients worldwide
• Estimated $1,000 in reimbursement per procedure in
the US
• Capital equipment sales price of $120K per machine
• Combination of Pay Per Procedure and Capital Combination of Pay Per Procedure and Capital
Equipment business model to address changing needs
for each territory
• ~10‐30% market share of the current global surgical
market (Trab & Shunts) in 5 years
• Reaching sales of $60 million worldwide in 5 years
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IOPtimate™ Path of Value Creating Events g
2014 2015 2016 2017
IOPtiMateTMSales in EU and China ‐ Clinical
Study for the FDA
Sales in EU and ROW and Clinical Study for the FDA
Sales in EU and ROW and FDA
Approval
Commercialization in the US, EU and
the ROW
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The Eye‐D™ Solution ‐ Novel Rx Eye Insert
• Opportunity: 90% of Glaucoma patients are treated with eye dropsto lower intra‐ocular pressure; however only one in four use as
y y
Thickness 300 mto lower intra‐ocular pressure; however only one in four use asprescribed
• Known poor compliance and adherence with eye drops is a majorclinical challenge with no meaningful solutions
3 3 mm x 7.5 mm
clinical challenge with no meaningful solutions.
The Solution
b l h k l d l• A subconjunctival insert, targets the market leading Glaucomageneric drug Latanoprost (Xalatan® by Pfizer)
• Office procedurep
• Long‐term testing in rabbits, dogs & monkeys
• Pre‐IND discussion paved the way to IND submissionp y
• A broad platform technology
• Strong patent portfolio
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Eye‐DTM A $250‐400 Million Business Opportunity
• Latanaprost, which is also known by the brand name
y pp y
p , y
of Xalatanmanufactured by Pfizer, had annual sales of
approximately $1.7 billion in 2012
• Insert with premium estimated at annual $600‐1,000 in
the US
• Estimated 5% USA market share within 5 years in the
market
• Reaching sales peak of $250‐400 million
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Eye‐D™ Path of Value Creating Events y g
2014 2015 2016 2017
Eye‐DTMQ2‐Q4/2014Phase I/IIa in
Human
Q1‐Q3/2015Phase IIb
Dose ranging study
Q4/2015‐Q4/2016Phase III
FDA Approval and Starting
Commercialization
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Ophthalmic Peer Company Valuationsp p y
Company Description Symbol Revenue (ttm) Market CapProvides Therapeutic based laser
IRIDEXProvides Therapeutic based laser systems for sight‐threatening eye diseases
IRIX $35.3 mln $59 mln
Si idDevelops drug delivery products for
PSDV $ l $8 lpSividap g y p
back‐of‐the‐eye diseasesPSDV $2.3 mln $84 mln
Nicox SA
Developing therapies and diagnostics to enhance sight, including a Phase III drug
NICXF n/m $233 mlnNicox SAfor glaucoma that is partnered with Bausch + Lomb
NICXF n/m $233 mln
Commercializing an in vitro diagnosticTearLab
Commercializing an in vitro diagnostic testing platform (TearLab® Osmolarity system) used to diagnose dry eye disease
TEAR $8.8 mln $432 mln
Designs develops manufactures and sellsStaar Surgical
Designs, develops, manufactures and sells implantable lenses for the eye
STAA $68.4 mln $469 mln
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Our Cancer Diagnostics ClusterOur Cancer Diagnostics Cluster
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Rich Portfolio with Focus on Market Needs
PersonalizedScreening Monitoring Diagnosis
PersonalizedTreatment
Colorectal Cancer Colon‐
MarCarePlex™Colon‐
MarCarePlex™mCRC‐Strat™mCRC‐Strat™
BreastCancer BRCABRCA
BladderCancer
CellDetect®Bladder
CellDetect®Bladder
CellDetect®Bladder
CellDetect®Bladder
Other Indications
®®Brain
Metastasis(Lung)
Brain Metastasis(Lung)
BRONJBRONJCellDetect®Cervical
CellDetect®Cervical
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The Technologiesg
l l b k ( )
Technology Description Technology Description
Colon‐MarCarePlex ™
A Molecular biomarker (RNA)panel for screening advancedadenoma and colorectal cancer(CRC)
A novel histochemical staining kit foridentification of cervical neoplasia inhistological and cytological samples
CellDetect® Cervical
mCRC‐Strat™
Predictive multi‐biomarker IHCassay for the stratification ofmetastatic CRC patients eligible
A novel histochemical staining kitfor monitoring bladder cancerrecurrence in urine samples
CellDetect® Bladder
BrainPredictive gene expressionprofiling assay to identify lung
for anti EGFR therapyp
Predictive genetic (SNP) test foridentification of individuals withi d i k d l BRONJ Brain
Metastasisprofiling assay to identify lungcancer patients who are atincreased risk to develop brainmetastasis
increased risk to develop BRONJ, adevastating side effect followingtreatment with Bisphosphonatedrugs
BRONJ
Bio‐Gene
A functional gene expressionprofiling assay to identify carriers ofdeleterious BRCA mutations whoare at increased risk to developbreast and/or o arian cancerbreast and/or ovarian cancer
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Portfolio of Multiple Technologies & Productsp g
Research Stage Feasibility Stage Validation Stage Registration & Commercialization
CellDetect®Cervical
BRONJ
CellDetect®BladderBladder
Bio‐Gene
Colon‐MarCarePlex™
mCRC‐Strat™
BrainBrainMetastasis
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CellDetect® ‐ An Innovative Platform for Identifying and Diagnosing Pre Cancer and Cancer CellsPre‐Cancer and Cancer Cells
PAP Staining CellDetect® Staining
CellDetect® Staining
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CellDetect® Cervical Cancer
• A histo‐chemical cytology test for identifying cervical
cancer cells in cervical smear, based on the
CellDetect® patent protected platform technology
• Clinical proof of concept for identifying and
diagnosing the disease in cytology samples (sensitivity
of 92% and specificity of 80%) offering higher of 92% and specificity of 80%) offering higher
sensitivity over Pap and better specificity over HPV
tests
• Approved in Europe, Israel and China, initial
commercial efforts commencing this year
• Around 200 million annual tests globally with global
market of between $3 to $4 Billion.
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CellDetect® Bladder Cancer
• A histo‐chemical cytology test for identifying bladder
cancer cells in a urine sample, based on the
CellDetect®
• Clinical proof of concept trail shows 94% sensitivity
and 88% specificity in detecting bladder cancer cells in
urine samples urine samples
• About half million patients perform 3‐4 monitoring
tests a year with estimated market size of $200 tests a year, with estimated market size of $200
million in US alone
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CellDetect® Path of Value Creating Events g
2014 2015 2016 2017
CellDetect®Cervical Cancer
Commercialization in the Chinese
market
Commercialization in China and other
markets
Commercialization in China and other
markets
Commercialization in China and other
markets
CellDetect®Bladder Cancer
Validation clinical trial & registration
process
Approval & launch in EU and US markets
Commercialization Commercializationprocess markets
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Investment Summary
• World‐class management team with track record of industry success and with
significant board ownership
• Each technology clusters (XL Vision and Micromedic) has multiple opportunities
targeting sizable markets
• Clear strategy to regulatory approval and beginning commercialization on lead
opportunities in 2014
• Numerous value creating milestones over next 12‐24 months
• Attractive valuation relative to peer U.S. companies in ophthalmology
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Th k Y !Thank You!
For More information Contact:
In the United States In IsraelKen Trbovich Itai Bar‐NatanDirector ‐ Life Science Chief Financial OfficerCCG Investor Relations BioLight Life Sciences Investments LtdCCG Investor Relations BioLight Life Sciences Investments Ltd303‐668‐0537 972‐73‐[email protected] Itai@bio‐light.co.il
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