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JP Morgan Healthcare Conference January 2015
This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. We have based the forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us and our affiliate companies. There can be no assurance that such results will be realized and actual results in each case could differ materially from those currently anticipated in such statements as a result of various factors. BioLight is not under any obligation to update or correct any future forecasts and/or forecasting statements to reflect events or circumstances after the date of this presentation. BioLight makes no express or implied representation or warranty as to the achievement of the forecasts or the accuracy or completeness of the information contained herein. BioLight expressly disclaims any and all liability which may be based on such information, errors therein or omissions therefrom. This presentation does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or sell securities of BioLight.
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Safe Harbor Statement
World renowned leading management team and strong investor
base
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Company Highlights
Balanced portfolio focused on ophthalmic and cancer diagnostics
solutions targeting multibillion-dollar growing markets
Two technologies at initial commercial stage
Unique model encouraging knowledge and cost synergies
Traded in the TASE (BOLT) and in the OTCQX (BLGTY)
Ophthalmic Field
Developing and commercializing technologies in Glaucoma and Dry Eye Syndrome
BioLight - Addressing Two Medical Fields with Market Potential of Multibillion-Dollar
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Cancer Diagnostics Field
Developing and commercializing diagnostics tools for different types of cancers
Our Ophthalmic Field Portfolio:
Glaucoma and Dry Eye Syndrome
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More than 100M patients worldwide
Accounts for 40% of visits to eye doctors
Unmet needs:
Diagnostics
Treatment
Monitoring
~70M patients worldwide
$5 billion market
Unmet needs:
Low compliance to eye-drops
Significant side effects to existing
treatments
Eye-D®
IOPtiMateTM
TeaRx
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Our Ophthalmology Portfolio - Targets Growing Unmet Needs
Gla
uco
ma
Dry
Eye
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Eye-D®
Controlled release drug-delivery insert platform
A broad platform technology
Strong patent protection
Long-term controlled release drug through subconjunctival insert to be used as a platform for eye drops
First indication targets the market leading Glaucoma generic drug latanoprost (Xalatan® by Pfizer)
Eye-D® Solution - Novel Rx Eye Insert
Thickness 300 m 3 mm x 7.5 mm
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Humans: invisible below lower eye lid
Simple in-office procedure
The Solution
Eye-D® - Market Potential
9 Source: American Glaucoma Society Glaucoma Research Foundation
Additional potential:
• Expand to rest of the world markets
• Use beyond Glaucoma - anterior & posterior segments
• Applications beyond ocular drugs uses
~10M Glaucoma patients in the U.S.
~3M diagnosed
patients
~2M patients
prescribe with
latanaprost
~1M patients getting other
treatments (drugs &
surgeries)
$3.2B market potential of Latanoprost insert in the U.S. alone
Insert price estimated at annual of $800 per eye
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Eye-D® - Latanoprost Insert Development Status
A 505(b)(2) regulatory approval pathway
Phase 1/2a clinical trial ongoing in 7 centers in the U.S.
Results expected in H2/15
Additional indications under review
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IOPtiMate™
Non-penetrating medical procedure for Glaucoma
The IOPtiMateTM Procedure - Efficiency and Safety!
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The IOPtiMateTM system
• A new laser-assisted surgical tool that enables eye
surgeons to perform an accurate Deep Sclerectomy
Glaucoma Surgery
• Reduces elevated intraocular pressure by thinning the
sclera without penetrating the eyeball
• Transforms complex and highly risky glaucoma surgery
into a safe and precise laser-assisted procedure
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Worldwide Clinical Results Performed on 111 patients in 9 sites with 5-years follow up
Source: Am J Ophthalmol. 2009 Nov;148(5):670-84; 2009 Aug 11; Three-year follow-up of the tube versus trabeculectomy study; Gedde SJ, American Journal of Ophthalmology (2007) Volume: 143, Issue: 1, Pages: 23-31; Surgical complications In the Tube Versus Trabeculectomy Study during the first year of follow-up; Steven J Gedde
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$1.5B global market potential
The IOPtiMateTM Market Potential
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Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011
Company estimations
~1.5M annual surgical
procedures
~0.5M trabeculectomy
& shunts procedures
~1M trabeculoplasty
procedures
Estimated reimbursement of $1,000 in the U.S.
• More than 700 clinical procedures
performed globally to date
• 4 Regulatory approvals in Europe, China,
Mexico and Israel, additional in process
• Distribution agreements in place in multiple
locations - commercial sales begun in Q4/14
• Systems installed worldwide
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IOPtiMateTM Status
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TeaRx
Point-of-care multi-parameter diagnostic
test for Dry Eye Syndrome
The TeaRx approach is to assemble several
parameters to achieve a rapid, simple, semi-
quantitative analysis of the tear film
A novel multi-parameter diagnostic test that
enables diagnosis, companion diagnostics
and monitoring of Dry Eye Syndrome
TeaRx - A Breakthrough Solution for Dry Eye Syndrome Diagnostics
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Advantages:
• Multiple parameters
• Low-cost & easy to use
• Easy reading
• Companion diagnostics potential
Only 1 drug has FDA approval (Restasis,
Allergan) which treats only 20% of the patients
High need for personalized treatment and
companion diagnostics solutions
About 12 new drugs in Phase II/Phase III
development stage
About 100 million people suffer from the
syndrome worldwide, 20-30 million in the U.S.
alone
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Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011
Companiesandmarkets.com , Apr 2013
Dry Eye Syndrome - High Need for Diagnostics and Treatment
Diagnostics Treatment
The reason for 40% of the eye doctor visits
~300 million people suffer from the symptoms
TeaRx - Development Status
Human clinical trials in U.S. and Israel
Results expected in Q1/15
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IOPtiMateTM
Ophthalmic Portfolio 2015 Events
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• Phase 1/2a clinical trial results H2/2014
• Preparation for Phase 2b
• Expanding IOPtiMate sales
• Securing regulatory approvals in Canada, Taiwan and
additional countries
Eye-D®
• Clinical trial results (Q1/15)
• Industrialization TeaRx
• Investing in new ophthalmic technologies
Our Cancer Diagnostics Portfolio
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Source: *WHO, Globocan 2008, NIH ,American Cancer Society 2012 **Harvard Business Review
On average 25% of existing cancer treatments are effective & varies from one patient to another
Diagnostic tests allow matching of effective treatment to patient and maximizing treatment value
Cancer is the leading cause of death worldwide (around 13% of all deaths)
and is expected to reach 9 million deaths in 2015
Early detection by advanced diagnostic methods saves lives
Cancer Diagnostics Market - Unmet Need
Personalized Medicine
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2000 2008 2015 2030
6.3 7.6
8.9
13.1
9.9
12.7
14.9
21.3
Global Cancer Incidence
Global Cancer Mortality
CellDetect®
Prostate/CTC
Rich Portfolio Focused on Market Needs
Screening Monitoring Diagnosis Personalized Treatment
Multiple Myeloma
Cervical Cancer
Bladder Cancer
Other Indications
Colon-MarCarePlex™
BRCA
CellDetect®
Bladder
CellDetect® Bladder
Brain Metastasis
(Lung)
BRONJ
CellDetect® Cervical
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CellDetect®
A powerful oncology histochemical
diagnostics platform
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The CellDetect® Technology Overview
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Proprietary kit containing unique extract and dyes
Standard processes utilized in pathology laboratories
The only assay allowing color discrimination between
and cells and morphological examination
The CellDetect® technology allows the same number of pathologists
to perform significant higher number of tests
PAP Test CellDetect® Test
The 4th most common cancer in women world wide
• ~200M annual tests globally with market potential of billions of dollars
• 9 of 10 cervical cancer deaths occur in emerging markets that do not have an effective screening process
• Markets require a simple, accurate low cost solution
• Market potential of 500M tests in China and India
• CE and SFDA regulatory approvals
• Initiated commercial activity in China
• On-going clinical activity in India
Cervical Cancer Detection - Unmet Need in Emerging Markets
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Source: Globocan 2012
Sensitivity Specificity
CellDetect® 92% 80%
Pap Test 79% 82%
HPV Test 84% 39%
• Up to 80% recurrence requires life long monitoring & treatment
• Making it the most expensive to treat on a per patient basis
• Current gold standard tests are invasive, expensive, or lack clinical efficacy
• Over 1.5M annual monitoring tests currently performed in the US alone
• On-going multi-center clinical trial
Source: Avalere, globocan 2012, Bladder Cancer Advocacy Network; Bladder Cancer Fact Sheet
Bladder Cancer Detection - A large Market Opportunity
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The 7th most diagnosed cancer in men worldwide
Proof of Concept & Blinded Study Interim Results
Sensitivity Specificity
CellDetect® 88-95% 68-89%
Bladder cancer urine test
Circulating Tumor
Cells blood test
Cervical cancer
test
Prostate cancer urine test
Lung cancer sputum
test CellDetect®
Platform
Platform Automation
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CellDetect® Platform
BRONJ A diagnostic test for detecting patients at
risk to develop BRONJ
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Cancer Indications Osteoporosis
Source: Globocan 2012
≤12%
100,000 Annual
Multiple Myeloma patients
60,000 Annual
Prostate Cancer
patients
300,000 Annual Breast Cancer
patients
≤18% ≤7%
200M Osteoporosis
patients
≤ 200,000
Target market
BRONJ prevalence
The BRONJ Potential Market
BRONJ - a devastating side effect of bisphosphonates therapy resulting in bone necrosis of the jaw
There is no available test for predicting BRONJ
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Development Status
• Multiple Myeloma clinical trials ongoing in U.S. and Israel
• Extension of clinical trial to other indications in 2015
CellDetect® Cervical
Cancer Diagnostics Portfolio 2015 Events
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• Multicenter clinical trial results - Q1/15
• Regulatory filing based on clinical trial results
• Expending sales in China
• Initiate sales in India - H2/15
• Additional markets penetration
CellDetect® Bladder
• Clinical trial in multiple myeloma patients results - Q1/15
• Extended trial to other indications - H2/15 BRONJ
45.00%
20.00%
35.00%
Corporate and Financial Summary
• Israel Makov, the former President & CEO of
Teva Pharmaceuticals
• Dilip Shanghvi , the founder and managing
director of Sun Pharma, India’s largest
pharmaceutical company by market cap1
• Dan Oren , the founder, President & CEO of
Dexcel Pharma, the 2nd largest pharmaceutical
manufacturer in Israel2
Sources: 1. Crisil Ratings 2. IATI, Israel Advanced Technology Industries 32
Pri
vate
In
vest
ors
• Traded on Tel Aviv Stock Exchange (BOLT) and OTCQX (BLGTY)
• 521.3 million shares outstanding; 791.1 million fully diluted
• Market Cap of $25M, Avg. Trading Volume 2.03 million shares
• Backed by private investors with significant biopharmaceutical experience and reputable institutional
investors as follows:
Private Strategic Investors (45%)
Institutional (20%) Public (35%)
Corporate and Financial Summary (cont.)
Strong Cash Position
• $9 million as of September 30, 2014
• Funds operational needs into 2016 and investment in new technologies
• Expected significant milestones and value creating events during this time period
Other
• Included in the Tel-Aviv Biomed Index (TA – Biomed) and also in the Tel-Aviv Technology index
(TA – BlueTech), effective June 15, 2014
• Since then tripled its weight in the TA- Biomed Index
• Analysts coverage initiated recently by Zacks and Merriman Capital
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BioLight Offers
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Technologies
Multiple Opportunities in High Growing markets
Unique Business Model
Leading Team
Balanced and focused innovative technologies
Targeting growing markets of multiple billions of dollars
Unique business model conductive to accelerate innovation
World renowned management team and based investors
Heading Towards a Bright Future….
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Thank You!