JP Morgan Healthcare Conference January 2015

JP Morgan Healthcare Conference
January 2015
Safe Harbor Statement
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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Company Highlights
Unique model encouraging knowledge and cost synergies
Balanced portfolio focused on ophthalmic and cancer diagnostics
solutions targeting multibillion-dollar growing markets
World renowned leading management team and strong investor
base
Two technologies at initial commercial stage
Traded in the TASE (BOLT) and in the OTCQX (BLGTY)
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BioLight - Addressing Two Medical Fields with Market Potential of
Multibillion-Dollar
Ophthalmic Field
Cancer Diagnostics Field
Developing and commercializing
technologies in Glaucoma and
Dry Eye Syndrome
Developing and commercializing
diagnostics tools for different
types of cancers
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Our Ophthalmic Field Portfolio:
Glaucoma and Dry Eye Syndrome
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Our Ophthalmology Portfolio - Targets Growing Unmet Needs
Eye-D®
Glaucoma
~70M patients worldwide
$5 billion market
Unmet needs:

Low compliance to eye-drops

Significant side effects to existing
treatments
IOPtiMateTM
TeaRx
Dry Eye
More than 100M patients worldwide
Accounts for 40% of visits to eye doctors
Unmet needs:

Diagnostics

Treatment

Monitoring
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®
Eye-D
Controlled release drug-delivery
insert platform
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Eye-D® Solution - Novel Rx Eye Insert
The Solution
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)
Humans: invisible
below lower eye lid
Simple in-office procedure
A broad platform technology
Strong patent protection
Thickness 300 m
3 mm x 7.5 mm
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Eye-D® - Market Potential
~10M Glaucoma
patients in the U.S.
$3.2B market potential of Latanoprost insert in
the U.S. alone
~3M
diagnosed
patients
Insert price estimated at annual of $800 per eye
Additional potential:
•
Expand to rest of the world markets
•
Use beyond Glaucoma - anterior &
posterior segments
•
Applications beyond ocular drugs
uses
Source:
American Glaucoma Society
Glaucoma Research Foundation
~1M
patients
getting
other
treatments
(drugs &
surgeries)
~2M
patients
prescribe
with
latanaprost
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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
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The IOPtiMateTM Procedure - Efficiency and Safety!
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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The IOPtiMateTM Market Potential
~1M
trabeculoplasty
procedures
$1.5B global market potential
Estimated reimbursement of
$1,000 in the U.S.
~0.5M
trabeculectomy
& shunts
procedures
~1.5M annual
surgical
procedures
Source:
Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo:
Market Scope, November 2011
Company estimations
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IOPtiMateTM Status
•
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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TeaRx
Point-of-care multi-parameter diagnostic
test for Dry Eye Syndrome
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TeaRx - A Breakthrough Solution for Dry Eye Syndrome Diagnostics
A novel multi-parameter diagnostic test that
enables diagnosis, companion diagnostics
and monitoring of Dry Eye Syndrome
The TeaRx approach is to assemble several
parameters to achieve a rapid, simple, semiquantitative analysis of the tear film
Advantages:
•
Multiple parameters
•
Low-cost & easy to use
•
Easy reading
•
Companion diagnostics potential
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Dry Eye Syndrome - High Need for Diagnostics and Treatment
Diagnostics
About 100 million people suffer from the
Only 1 drug has FDA approval (Restasis,
syndrome worldwide, 20-30 million in the U.S.
Allergan) which treats only 20% of the patients
alone
~300 million people suffer from the symptoms
The reason for 40% of the eye doctor visits
Source:
Treatment
About 12 new drugs in Phase II/Phase III
development stage
High need for personalized treatment and
companion diagnostics solutions
Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St.
Louis, Mo: Market Scope, November 2011
Companiesandmarkets.com , Apr 2013
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TeaRx - Development Status
Human clinical trials in U.S. and Israel
Results expected in Q1/15
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Ophthalmic Portfolio 2015 Events
• Expanding IOPtiMate sales
IOPtiMateTM
• Securing regulatory approvals in Canada, Taiwan and
additional countries
Eye-D®
TeaRx
• Phase 1/2a clinical trial results H2/2014
• Preparation for Phase 2b
• Clinical trial results (Q1/15)
• Industrialization
• Investing in new ophthalmic technologies
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Our Cancer Diagnostics Portfolio
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Cancer Diagnostics Market - Unmet Need
Cancer is the leading cause of death worldwide (around 13% of all deaths)
and is expected to reach 9 million deaths in 2015
21.3
Early detection by advanced diagnostic methods saves lives
14.9
13.1
12.7
Global Cancer Incidence
9.9
6.3
7.6
8.9
Global Cancer Mortality
2000
2008
2015
2030
Personalized Medicine
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
Source: *WHO, Globocan 2008, NIH ,American Cancer Society 2012
**Harvard Business Review
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Rich Portfolio Focused on Market Needs
Screening
Bladder
Cancer
Cervical
Cancer
Personalized
Treatment
Diagnosis
CellDetect®
Bladder
CellDetect®
Bladder
CellDetect®
Cervical
Multiple
Myeloma
Other
Indications
Monitoring
BRONJ
ColonMarCarePlex™
Brain
Metastasis
(Lung)
BRCA
CellDetect®
Prostate/CTC
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®
CellDetect
A powerful oncology immunohistochemical
diagnostics platform
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The CellDetect® Technology Overview
PAP Test
CellDetect® Test
The only assay allowing color discrimination between
and
cells and morphological examination
Proprietary kit containing unique extract and dyes
Standard processes utilized in pathology laboratories
The CellDetect® technology allows the same number of pathologists
to perform significant higher number of tests
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Cervical Cancer Detection - Unmet Need in Emerging Markets
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
Sensitivity
Specificity
CellDetect®
92%
80%
Pap Test
79%
82%
HPV Test
84%
39%
Source: Globocan 2012
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Bladder Cancer Detection - A large Market Opportunity
The 7th most diagnosed cancer in men worldwide
•
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
Proof of Concept & Blinded Study Interim Results
CellDetect®
Sensitivity
Specificity
88-95%
68-89%
Source: Avalere, globocan 2012,
Bladder Cancer Advocacy Network; Bladder Cancer Fact Sheet
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CellDetect® Platform
Cervical
cancer
test
Lung
cancer
sputum
test
Platform
Automation
CellDetect®
Platform
Prostate
cancer
urine
test
Bladder
cancer
urine
test
Circulating
Tumor
Cells blood
test
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BRONJ
A diagnostic test for detecting patients at
risk to develop BRONJ
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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
Cancer Indications
Target
market
Osteoporosis
100,000
Annual
Multiple
Myeloma
patients
300,000
Annual
Breast
Cancer
patients
60,000
Annual
Prostate
Cancer
patients
200M
Osteoporosis
patients
≤18%
≤12%
≤7%
≤ 200,000
BRONJ
prevalence
Development Status
• Multiple Myeloma clinical trials ongoing in U.S. and Israel
• Extension of clinical trial to other indications in 2015
Source: Globocan 2012
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Cancer Diagnostics Portfolio 2015 Events
CellDetect®
Cervical
CellDetect®
Bladder
BRONJ
• Expending sales in China
• Initiate sales in India - H2/15
• Additional markets penetration
• Multicenter clinical trial results - Q1/15
• Regulatory filing based on clinical trial results
• Clinical trial in multiple myeloma patients results - Q1/15
• Extended trial to other indications - H2/15
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Corporate and Financial Summary
•
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:
•
Israel Makov, the former President & CEO of
Private Investors
•
director of Sun Pharma, India’s largest
•
35.00%
Dilip Shanghvi , the founder and managing
pharmaceutical company by market
Public (35%)
Institutional (20%)
Teva Pharmaceuticals
20.00%
cap1
Dan Oren , the founder, President & CEO of
45.00%
Dexcel Pharma, the 2nd largest pharmaceutical
manufacturer in Israel2
Private Strategic Investors (45%)
Sources:
1. Crisil Ratings
2. IATI, Israel Advanced Technology Industries
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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
Technologies
Balanced and focused innovative technologies
Unique Business Model
Unique business model conductive to accelerate innovation
Multiple Opportunities in High Growing markets
Targeting growing markets of multiple billions of dollars
Leading Team
World renowned management team and based investors
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Heading Towards a Bright Future….
Thank You!
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