company presentation - biolight · 2017-11-29 · $1.5b global market potential ioptimatetm market...
TRANSCRIPT
Company Presentation
June 2015
This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. We have based all 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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Forward-Looking Statements
Rich product portfolio at various clinical and commercial stages
Proven management team with strong track record of success,
backed by strategic investors with significant biopharmaceutical
experience
Unique model encouraging knowledge and cost synergies
Strong news flow will provide multiple value inflection events
through 2016 and beyond
Targeting large and growing patient populations with significant
unmet medical needs
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Company Highlights
Corporate and Financial Summary
Israel Makov, former President & CEO of Teva Pharmaceuticals
Dilip Shanghvi, founder and managing director of Sun Pharma,
India’s largest pharmaceutical company by market cap1
Dan Oren, founder, President & CEO of Dexcel Pharma, the 2nd
largest pharmaceutical manufacturer in Israel2
Rock One, Hong Kong based company specialized in the
biomed and high-tech industries
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Str
ate
gic
In
vest
ors
Traded on Tel Aviv Stock Exchange (BOLT) and OTCQX (BLGTY)
644.7 million shares outstanding; 872.2 million fully diluted
Backed by strategic investors with significant biopharmaceutical experience:
Institutional (16%)
Public (29%)
Strategic Investors (55%)
Sources: 1. Crisil Ratings 2. IATI, Israel Advanced Technology Industries
Ophthalmic Therapeutics &
Diagnostics
BioLight - Current Structure
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Cancer Diagnostics
46%* 100%
* Controlling ownership
XLVision Ophthalmic Portfolio
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More than 100M patients worldwide = ~$3B market
Accounts for 40% of all visits to U.S. eye doctors
Unmet medical needs:
Diagnostics, personalized treatments & treatment monitoring
~70M patients worldwide = ~$5B market
Unmet medical needs:
Low compliance to eye drops
Significant side effects with existing treatments
Eye-D®
IOPtiMateTM
TeaRxTM
Ophthalmic Portfolio - Targeting Large and Growing Patient Populations
Gla
uco
ma
Dry
Eye
OphRx
More than 30M patients worldwide = ~$3B market
Unmet medical need:
Current therapies require frequent intravitreal injections
AM
D
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Eye-D®
Controlled Release Drug-Delivery Insert Platform
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A broad platform technology
IP includes strong protection for chemical structures for entire PGA Class and a method patent for elution profile
Long-term controlled release 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® - A Novel Rx Eye Insert Solution
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
10 Source: American Glaucoma Society Glaucoma Research Foundation
Additional potential:
Expand to rest of the world
Additional applications for drug delivery beyond Glaucoma - anterior & posterior segments
Additional applications beyond ocular uses
~10M Glaucoma patients in the U.S.
~3M diagnosed
patients
~2M patients prescribed
with latanoprost
~1M patients getting other
treatments (drugs &
surgeries)
$3.2B market potential of latanoprost insert in the U.S. alone
Annual Eye-D® insert price estimated at $800 per year
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Eye-D® - Latanoprost Insert Development Status
A 505(b)(2) regulatory approval pathway
Phase 1/2a clinical trial to evaluate safety and
efficacy of 3 doses of latanoprost ongoing across
the U.S.
• 3 months insert duration
• 3 arms, 1 control arm (latanoprost eye drops)
• Investigator masked for dose
• Up to 68 patients in 7 centers in the U.S.
Results expected in H1/16
IOPtiMate™ Non-Penetrating Medical Procedure for Glaucoma
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Refractive: 1983 - IntraLasik
Glaucoma: The IOPtiMateTM
Cataract: 2009 - Laser Capsulotomy
Laser - A Magic Word in Ophthalmology
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The IOPtiMateTM Procedure - High Efficacy and Safety
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The IOPtiMateTM system
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 the current complex and highly risky
glaucoma surgery into a safe and precise laser-assisted
procedure
Worldwide Clinical Results
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 7
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Performed on 111 patients in 9 sites with 5-years follow up
$1.5B global market potential
IOPtiMateTM Market Potential
16 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 globally
~0.5M trabeculectomy
& shunts procedures
~1M trabeculoplasty
procedures
Estimated reimbursement of $1,000
More than 1,500 clinical procedures
performed globally to-date
4 Regulatory approvals in Europe, China,
Mexico and Israel and additional in process
Current commercial focus on Asia and EU markets
Distribution agreements in place in multiple locations - commercial sales began in Q4/14
20 Systems installed worldwide
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IOPtiMateTM Current Status
TeaRxTM
Multi-Parameter Diagnostic Test
for Dry Eye Syndrome
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The TeaRxTM 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 (DES)
TeaRxTM - A Breakthrough Diagnosis Solution for Dry Eye Syndrome
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Advantages:
Multiple parameters
Low-cost & easy to use
Easy reading
Sub-groups identification
Only 1 drug currently has FDA approval (Restasis,
Allergan); approx. 12 new drugs in Phase II/Phase III
development
Strong demand for personalized treatment and
companion diagnostics solutions
Current diagnostics (e.g. osmolarity) cannot
determine cause of this multi-factorial syndrome
More than 100 million people suffer from moderate-
to-severe DES worldwide, 40 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 - Market Potential
Diagnostics Treatment
The reason for 40% of all visits to U.S. eye doctors
~300 million people globally suffer from one or more
DES symptoms
Existing reimbursement codes
TeaRxTM - Development & Commercial Status
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Completed 1st human clinical trial in the U.S.
Significant correlation of benchmark tests to the TeaRxTM parameters
Ongoing 2nd clinical trial to assess the effectiveness of the tests in
tears of healthy subjects as well as patients with severe DES
Study results are expected in H2/2015
Rich patent portfolio
Existing reimbursement codes
Collaboration with Ora Inc.
OphRx Novel Lyotropic Delivery Platform
for Ocular Uses
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Technology is based on crystal liquid vehicles for the improvement of molecule transport across membranes
Unique crystal liquids structure allows loading of different kind of molecules and release them in different target areas
Proven successful commercial uses in other industries
Successful demonstration of ocular bioavailability for the technology has been performed
OphRx Technology Platform - Lyotropic Liquid Crystals (LLC)
The Platform Structure
(Illustration)
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Serves as a technology platform for transporting drugs across membranes in different areas within the eye
Controlled release drugs capabilities
Can solubilize very large loads of therapeutic
Safe to use (GRAS ingredients)
Protecting unstable drugs
Clear and stable formulations
OphRx Potential Advantages for Ophthalmic Uses
70 Million patients,
$5 Billion market
Glaucoma
100 Million patients,
$3 Billion market
Dry Eye Syndrome
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30 Million patients,
$3 Billion market
Age-Related Macular Degeneration (AMD)
OphRx - Market Potential
IOPtiMateTM
Ophthalmic Portfolio Value Inflection Events Through 2016
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• Phase 1/2a clinical trial results (H1/2016)
• Preparation for Phase 2/b (H2/2016)
• Expanding IOPtiMateTM sales
• Securing regulatory approvals in Canada, Taiwan and additional countries
• Regulatory process in the U.S.
Eye-D®
• Clinical trial results (H2/2015)
• Industrialization (H1/2016)
• Regulatory process in the U.S. (H1/2016)
TeaRxTM
OphRx • Pre-Clinical results (H1/2016)
• Preparation for human trials to (start in H1/2017)
Micromedic
Cancer Diagnostics Portfolio
Rich Portfolio Focused on Market Needs
Screening Monitoring Diagnosis Personalized
Treatment
Multiple Myeloma
Cervical Cancer
Bladder Cancer
Other Indications
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POC Projects
CellDetect®
Bladder CellDetect®
Bladder
CellDetect®
Cervical
BRONJ
BRCA Brain Metastasis
CellDetect®
CTC CellDetect®
Lung CellDetect®
Prostate
A powerful oncology histochemical diagnosis platform
targeting multiple applications
The CellDetect® Technology Overview
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PAP Test CellDetect® Test
Proprietary assay containing unique extract and dyes
Only assay allowing color discrimination between Normal and
Neoplastic cells alongside morphological examination
Standard processes utilized in pathology laboratories
Applicable for liquid-based and conventional cytology
The CellDetect® technology allows the same number of pathologists to perform significantly higher number of tests!
Sensitivity Specificity
76-85% 90-95% CellDetect®
55-79% 79-97% PAP 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 & commercial activity in India
Cervical Cancer Screening - Unmet Need in Emerging Markets
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Source: Globocan 2012 Diagn Cytopathol. 2012 40(12):1054-61 (Epub 2011 May 31) Obstet Gynecol 2008;111:167–77
The CellDetect® Staining was found to be more accurate and cost effective then the HPV test
• Up to 80% recurrence requires life long monitoring & treatment
• Current gold standard tests are invasive, expensive, or lack clinical efficacy
• Over 1.5M annual monitoring tests currently performed in the US alone and around 4 million annual cystoscopies performed in the U.S.
• Excellent multi-center clinical trial results
• Awaiting CE approval
Source: Avalere, globocan 2012, Bladder Cancer Advocacy Network; Bladder Cancer Fact Sheet
Bladder Cancer Detection - A large Market Opportunity
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7th most common cancer in men world wide and among most expensive to treat
No. of cases Performance
96 84.4% Sensitivity
121 82.7% Specificity
The CellDetect® staining was found to be more easy to use, cost effective and accurate in both early and later stage tumors than other non-invasive tests
CellDetect® Cervical
Cancer Diagnostics Value Inflection Events Through 2016
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• Awaiting CE approval
• Initiate sales in Europe (H1/2016)
• Regulatory process in the U.S. (H1/2016)
• Expending sales in China
• Initiate sales in India (H2/2015)
• Additional markets penetration
CellDetect® Bladder
• Clinical trial in multiple myeloma patients results (H2/2015) BRONJ
Others • Seeking for strategic partners
• Completion of CellDetect® POC trials
In Summary
Leading Team
Multiple Opportunities in High Growth Markets
Unique Business Model
Strong Pipeline
Investment Highlights
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Reduced risk related to diverse portfolio of ground-breaking technologies
Attractive offering targeting large and growing patient populations with significant unmet medical needs
Increased ROI through unique business model conductive to accelerate innovation
Management team and strategic investors with track record of success