corporate presentation april 2018 - biolight...higher costs than eye drops for such treatments eye-d...
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Corporate PresentationApril 2018
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Forward-Looking Statements
This presentation has been prepared for informational purposes only and does not purport to beall-inclusive.
We have based all forward-looking statements on our current expectations and projections aboutfuture 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 assurancethat such results will be realized and actual results in each case could differ materially from thosecurrently anticipated in such statements as a result of various factors. BioLight is not under anyobligation to update or correct any future forecasts and/or forecasting statements to reflectevents or circumstances after the date of this presentation.
BioLight makes no express or implied representation or warranty as to the achievement of theforecasts or the accuracy or completeness of the information contained herein. BioLight expresslydisclaims any and all liability which may be based on such information, errors therein or omissionstherefrom.
This presentation does not constitute an offer to sell or the solicitationof an offer to subscribe for or buy or sell securities of BioLight.
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• Focused on discovery, development and commercialization of products which target ophthalmic conditions including:
• Glaucoma
• Dry eye syndrome (DES)
• Age-related macular degeneration (AMD)
• Products are designed to address a number of significant unmet medical needs by:
• Reducing burden of treatment
• Improving compliance, efficacy and safety of treatment
• Offering better diagnosis and personalize treatment
• Optimizing delivery of medications
Overview
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Corporate Information
• Traded on Tel Aviv Stock Exchange (BOLT)
• 3.6 million shares outstanding
• Backed by strategic investors with significant life sciences experience
• Israel Makov, former President & CEO of Teva Pharma
• Dilip Shanghvi, founder and managing director of Sun Pharma,
India’s largest pharmaceutical company by market cap
• Dan Oren, founder, President & CEO of Dexcel Pharma, the 2nd
largest pharmaceutical manufacturer in Israel
• Rock One, Hong Kong based company specialized in the
biomed and high-tech industries
Str
ate
gic
In
vest
ors
Public (33%)
Institutional(10%)
Strategic Investors (57%)
• Collection of ocular disorders characterized by progressive loss of visual field due to optic nerve damage
• Usually involves uncontrolled increase in Inter Ocular Pressure (IOP)
• Can lead to progressive, irreversible vision loss and blindness
• Chronic disease that requires ongoing, lifelong treatment
• Multi-factorial disorder of the ocular surface
• Eye produces insufficient tears or tears with abnormal composition
• Results in discomfort and visual disturbance
• In most severe forms, can lead to permanent vision loss
• Chronic, degenerative eye disease that affects the macula, the central part of the retina, at the back of the eye
• Leading cause of permanent vision loss and irreversible blindness among people aged 60 and older
Targeting Three Major Ophthalmic Conditions
GlaucomaOver 80 million
patients worldwide
(~7.3 million in U.S.)
Dry Eye Syndrome350 million
patients worldwide
(50 million in U.S.)
AMD30 – 50 million
patients worldwide
(15 million in U.S.)
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Source: Market Scope: 2015 Report on the Global Glaucoma Surgical Device Market; AMD.org: AMD Partnership Features Age Related Macular Degeneration Info; MasterEyeAssociates: Definition of Dry Eye Disease; F1000 Prime Reports: Advances in the management of macular degeneration; American Society of Retina Specialists: Millions of Americans Have Age-Related Macular Degeneration (AMD) – Many without Even Knowing It; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit
• High need for objective, accurate and easy to use diagnostic tools• Strong demand for personalized treatment and companion
diagnostics solutions• High need for new drugs with better tolerability, efficacy with
lower ocular and systemic side effects
• Low compliance with prescribed administration of eye drops
• Safer and more precise alternative to the complex and risky surgeries
• Reduce burden of treatment
Eye-D
IOPtiMateTM
TeaRxTM
Gla
uco
ma
Dry
Eye
OphRx LLC• Reduce burden of treatment
• Greater efficacy & safety of medicationAM
DAddressing Several Significant Unmet Medical Needs
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LIPITEARTM
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Our goal is to become a leading ophthalmic company by:
Our Strategy
Developing and expanding a balanced and diverse pipeline of ophthalmic products
and product candidates
Targeting large and
growing patient
populations with
significant unmet
needsMaintaining a global diverse network of
ophthalmic specialists to accelerate
knowledge synergies and innovation
Pursuing strategic
partnership
opportunities
Establishing a sales
force to maximize
the commercial
potential of our
products
Eye-D
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Approximately 50% of glaucoma
patients may be non-compliant
with their drug therapy
administration
Compliance is Key for Treatment Efficacy
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Eye-D : Product Positioning
No need for daily eye
drops
Effective for
3-6 months
Easy and safe in-office
procedure
Glaucoma standard
of care medication,
preservative free
Simple design,
solid IP
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Our Solution: Eye-D
• Platform technology that enables a controlled release of ophthalmic medications over time through a subconjunctival insert
• First product candidate (VS-101), contains latanoprost, the most prescribed glaucoma medication worldwide
• VS-101 Phase 1/2a clinical study in the U.S. as part of 505(b)(2) regulatory pathway was completed in July 2017
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Clinical Results Demonstrate Safety & Efficacy
Phase 1/2a protocol:
• Randomized, blinded, controlled
• Compared three different insert elution rates (high, medium & low) with latanoprost eye drops (control group)
• 39 subjects, 3 months duration
Day 1 Day 4 Day 84
Demonstrated:• Proof of concept in humans achieved• Safety endpoint achieved (no unanticipated findings, no severe adverse events)• Evidence for efficacious/preferred dose (high dose)• Supporting information for improving retention in phase 2b
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Clinical Results Demonstrate Safety & Efficacy
Safety Efficacy Supporting Information
• No severe adverse events were reported
• No conjunctival scarring, no infections
• >90% of the related adverse events were mild and transient
• Evidence for efficacious/preferred dose
• Procedure standardization:• Location• Depth• Suture• Inserter• Etc…
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Global glaucoma pharmaceutical market is expected to increase from approximately $4.7 billion in 2015 to nearly $6.1 billion in 2020
10-25% of newly prescribed
patients don’t refill their 2nd
prescription ~40-60% of
newly prescribed patients
are still taking their meds at
end of year 1
Nearly 75% of the patients indicate willingness to undergo a subconjunctival injection, while over 85% of patients willing to accept higher costs than eye drops for such treatments
Eye-D VS-101 Market Opportunity
Source: Market Scope: Charting the course of the eye care market.; Glaucoma Now – Issue No 2, 2013 Clinical Issues: Patient acceptance of ocular implants for Glaucoma Drug Delivery.Quigley HA Glaucoma: What Every Patient Should Know 2011; Friedman DS et al Invest Ophthalmol Vis Sci. 2007; Glaucoma Research Foundation; Market Scope
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IOPtiMate™
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Laser is a Magic Word in Ophthalmology
Refractive1983 - Excimer
Glaucoma2015 - IOPtiMateTM
Cataract2009 - Laser Capsulotomy
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Novel surgical system that enables a non-
penetrating, CO2 laser-assisted procedure
known as CLASS (CO2 Laser-Assisted
Sclerotomy Surgery) to reduce elevated IOP
The procedure is
automated, easy to
perform providing a
safer and more precise
alternative to the
complex and risky
glaucoma surgeries
IOPtiMateTM system can be combined with any
ophthalmic microscope and CLASS is
performed as an outpatient procedure,
requiring only local anesthesia
The IOPtiMateTM System: Transforming Glaucoma Surgery
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Worldwide Clinical Results Demonstrate High Efficacy & Safety
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
Clinical Trials Overview:
Data from multi-center clinical study performed on 111 patients in 9 sites with 5-years follow up demonstrate:• Significant long term IOP reduction, stable over time• Extremely low post operative complication rate• Long term reduction in medication
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Worldwide Clinical Results Demonstrate High Efficacy & Safety
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 7
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Binding Agreement of Investment in and Acquisition of IOPtima
In November 2017, we have entered into a binding agreement for the investment in and the
acquisition in stages of IOPtima by the Chengdu Kanghong Pharmaceutical Group Co:
First stage (completed at March 2018)
$7M investment into IOPtima
(pre-money valuation of $30M)
Second stage (H2/2018) –
acquiring 40% shares from
shareholders (valuation of $42M)
Third stage (Q2/2019) - acquiring
20% shares from shareholders
(valuation of $40-$56MM)
Forth stage (Q2/2021) - acquiring
20% shares from shareholders
(valuation of $40-$56MM)
If the second stage will be completed as planned, BioLight and its Board of Directors will positively
consider a dividend distribution to BioLight Shareholders.
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Designed to enable a wider range of
ophthalmic surgeons to perform glaucoma
surgeries
Has the potential to replace existing
glaucoma medical procedures driving an
increase in the quantity and quality of
glaucoma surgeries worldwide
Currently being marketed primarily in
Asia (mainly China, the world’s leading
country with glaucoma diagnosed patients), Europe, Canada and
Latin America
Over 4,000 CLASS procedures already
conducted worldwide to-date
IOPtiMateTM System Market Opportunity
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TeaRx™
Dry Eye Syndrome – Significant Unmet Needs
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350 million people worldwide suffer from Dry Eye Syndrome (DES)
There is a need for objective, actionable information that physicians can use to understand the root cause of patients complaints, enable personalized treatment, determine the effectiveness of the selected therapy and enable effective follow-up
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TeaRxTM : Transforming Dry Eye Disease Management
TeaRxTM
uses proprietary technology to deliver fast, semi-quantitative, personalized insights
to the causes of dry eye:
Collecting and diluting
A multichannel cassette- testing
several biomarkers simultaneously
Scoring based on intensity scale card
or electronic reader
Friendly output of multivariate
algorithm
Companion DiagnosticsSpecifically tailored biomarker assay development in order to
identify responders population for specific MOA
Point of CareA rapid, simple, office based, semi-quantitative analysis of the
tear film
Clinical trials• Strong correlation with benchmark tests (n=200) • 86% sensitivity and 87% specificity in identifying DES (n=74) • Final results from an additional clinical trial (n=82)
reconfirmed planned timeline for CE approval and FDA pivotal trial
Next steps• CE approval H2/2018• FDA pivotal trial –initiation H2/2018, approval H2/2019• Developing TearRx next generation, an electronic reader;
additional biomarkers providing more information to physician
Collaboration• Inserting our companion diagnostics tool into ph3 clinical
trial for a DES drug• Collaborating with a medical device company
Next steps• Partnering with additional companies to develop specific
algorithms and testing them in the context of clinical trials
TeaRxTM : Noval Platform, Multiple Applications
The TeaRxTM
is a novel platform for diagnosing and monitoring Dry Eye Syndrome (DES)
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TeaRxTM: Positive Clinical Trials Results
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• In a 200 DES patients study, the TeaRx demonstrated strong correlation with the
widely used benchmark tests (Schirmer, BUT, Staining, Questionnaire)
• In a 74 patients study, the TeaRx showed a 86% sensitivity and 87% specificity in
distinguishing between DES patients and healthy subjects
• A recent study enrolled 82 subjects (41 healthy, 41 with DES) reconfirmed planned
timeline in H2/2018 for CE approval and FDA pivotal trial
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TeaRxTM Market Opportunity
Source: MasterEyeAssociates: Definition of Dry Eye Disease; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit; The economic burden of dry eye disease in the United States: a decision tree analysis.
Existing tests diagnose signs & symptoms and measure
only single tear component
Only 2 drug currently has FDA approval,
Restasis, Allergan and Xiidra, Shire. Approx. 12
new drugs in Phase II/Phase III stage
Strong demand for personalized treatment
and companion diagnostics solutions
350 million people are effected by Dry Eye Syndrome
(DES) worldwide, of whom 50 million are in the U.S.
Diagnostics Treatment
One of the leading causes of patients’ visits to eye care
practitioners in the U.S.
No gold standard solution
Many therapeutics fail in Phase 3 due to
• Patients selection
• End points definitions
Overall estimated annual burden for the U.S. health-care
system of approximately $4 billion
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LIPITEAR™
LIPITEARTM : Product Description and Advantages
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• LIPITEAR™ - microemulsion consists of phospholipidis and triglycerides which forms a tear film-like elastic
lipid shield, a class III medical device, certified with a CE.
• LIPITEAR™ is indicated for use for ocular surgery post-operative (e.g. refractive surgery, cataract surgery
and corneal transplant), corneal erosions and Dry eye Syndrome
• LIPITEAR™ is the only product in the eye drop market with a clinically proven indication of enhancement
of corneal re-epithelization following mechanical, traumatic and surgical epithelial loss
• While other treatments for dry eye are mainly water-based artificial
tears supplemented with variety of viscose substances, LIPITEAR™
offers a formula which is the closest to the natural tear film and can
restore both the aqua layer and the protective lipid layer of the tear
film. This quality results in a prolonged relieving effect of severe dry
eye symptoms
The LIPITEARTM Platform Technology
• The LIPITEARTM is a micro-emulsion technology which consist of a combination of
phospholipids and triglycerides.
• Phospholipids advantages:
• Stabilize the tear film
• Maintain the tear film lipid structure organized in an orderly and elastic manner
• Triglycerides advantages:
• Reconstitute the physiological lipid shield, which controls the evaporation of tear film and
its optical properties
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The LIPITEARTM Plus: Platform Technology
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Being a micro-emulsion vehicle, the technology can be
used as a drug delivery platform
Its unique pharmaceutical advantages include:
• Longer contact time between the drug and the eye surface,
increasing compliance
• Dual treatment - dry eye treatment + treatment of other ocular
diseases using one eye drop
• Potential slow release capabilities with lipid solubility drugs
Leveraging platform technology capabilities to:
• Formulate advanced pharmaceutical preparations of
new as well as for known drugs
• Formation of an elastic lipid shield above the cornea
• Incorporation of lipophilic drug molecules
• Combination of hydrophilic and lipophilic molecules in one
preparation
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LIPITEARTM Plus: Pipeline Opportunity
Indication OTC/Rx Status
LPC-001LIPITEAR + nutrition supplement
Dry eye OTCPost Pre-Clinical
LPC-002LIPITEAR + new anti oxidant mechanism
Dry eye and anti-aging processes
OTC/RxPre-Clinical
LPC-003LIPITEAR new indication
Eye Protection OTCPost Pre-Clinical
LPC-004LIPITEAR + glaucoma API
Dry eye + Glaucoma
RxPre-Clinical
LPC-005LIPITEAR + New dose API
Ocular inflammation
RxPre-Clinical
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OphRx LLC
An alternative solution to current ocular drug delivery modalities
Topical drug delivery for both the front and the back of the eye
OphRx LLC Technology Platform
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Changing the Current Interavitreal Injections Administration To Eye Drops Administration
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• Technology designed for improved molecules’ transport across membranes
• Unique liquid crystals structures allow loading of different kind of molecules and their
release at different target areas
• Tailor-made formulations based on nano-sized, self-assembled liquid droplets and on
modified lyotropic liquid crystalline 2-3 dimensional structures loaded with API
molecules that are effectively released upon interaction with target tissues
• Indifferent to hydrophobic/hydrophilic constrains
• Results of preclinical studies showed that the delivery platform enables a safer more
efficient drug delivery for both the front and back of the eye
OphRx LLC Drug Delivery Technology Platform
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• Cost effective technology:
few months project for new molecule formulation
• High safety profile:
Leveraging commercially used APIs
All used particles and excipients are FDA-approved
• As easy to prepare as alka seltzer in a glass
• Dedicated IP per molecule
OphRx LLC Drug Delivery Technology Advantages
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Pipeline includes:
• Topical administration for back of the eye applications
• High potency front of the eye applications
Commercial value:
• Leveraging on commercial APIs
• Short route for new-molecules development
• Enhanced bioavailability
• Reduced side effects
• New claims based on bioavailability and new doses
• Potentially extending patent protection as a new delivery method
• Strong IP per molecule
OphRx LLC Pipeline and Commercial Value
AMD affects 30 to 50 million people worldwide, of whom 15 million are in the U.S.
Only 1 drug currently has FDA approval with limited efficacy and tolerability
DES affects 350 million people worldwide, of whom 50
million in the U.S.
600,000 new cases diagnosed globally each year, of which
over 200,000 are in the U.S
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A number of significant unmet needs in treating AMD, many of which stem from current need for frequent intravitrealinjections
OphRx LLC Market OpportunityD
ES
AM
D
Source: Market Scope: 2015 Report on the Global Glaucoma Surgical Device Market; AMD.org: AMD Partnership Features Age Related Macular Degeneration Info; MasterEyeAssociates: Definition of Dry Eye Disease; F1000 Prime Reports: Advances in the management of macular degeneration; American Society of Retina Specialists: Millions of Americans Have Age-Related Macular Degeneration (AMD) – Many without Even Knowing It; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit
• Potential for becoming the standard of care demonstrating high correlation with existing tests and superb diagnosis capabilities
• Third U.S. clinical trial completed• Collaboration with Pharma company for companion diagnostics
• Phase 1/2a completed
• Safety achieved, evidence for efficacious dose
• Front of the eye indications in pre-clinical stage
• Back of the eye indications in formulation stage
BioLight : Portfolio Status
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• Thousands of successful commercial procedures
• Signed agreement with Kanghong, with first stage completed
• First commercial product marketed in Europe
• 5 new indications in pre-clinical phase
Eye-D
IOPtiMateTM
TeaRxTM
Gla
uco
ma
Dry
Eye
OphRx LLC
AM
D
LIPITEARTM
• CE H2/2018• FDA Pivotal trial initiation H2/2018, approval H2/2019• Global product launch H2/2019• Companion Dx collaborations 2018-19
• Preparations for Phase 2b
• Completion of pre-clinical studies
BioLight : Next Milestones
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• Collaboration with Kanghong, including completion of second stage in H2/2018 and third stage in Q2/2019
• Sales ramp up, launch in additional countries
• R&D process with 5 indications
Eye-D
IOPtiMateTM
TeaRxTM
Gla
uco
ma
Dry
Eye
OphRx LLC
AM
D
LIPITEARTM
Multiple Opportunities in High-Growth MarketsOur pipeline addresses a number of significant unmet medical needs of large and growing patient populations
Strong Leadership TeamNotable combination of world-renowned key shareholders and experienced management team as well as a network of ophthalmic specialists
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In Summary
Innovative Business ModelMulti-product pipeline in various commercialization and development stages that, if successful, are expected to result in multiple value inflection events, lead to collaborations with other third parties, reduce risk to our business associated with a particular product or product candidate and increase return on investment