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. 2 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) 3 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 4 Our Ophthalmic Field Portfolio: Glaucoma and Dry Eye Syndrome 5 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 6 ® Eye-D Controlled release drug-delivery insert platform 7 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 8 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 9 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 10 IOPtiMate™ Non-penetrating medical procedure for Glaucoma 11 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 12 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 13 13 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 14 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 15 TeaRx Point-of-care multi-parameter diagnostic test for Dry Eye Syndrome 16 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 17 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 18 TeaRx - Development Status Human clinical trials in U.S. and Israel Results expected in Q1/15 19 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 20 Our Cancer Diagnostics Portfolio 21 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 22 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 23 ® CellDetect A powerful oncology immunohistochemical diagnostics platform 24 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 25 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 26 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 27 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 28 BRONJ A diagnostic test for detecting patients at risk to develop BRONJ 29 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 30 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 31 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 32 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 33 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 34 Heading Towards a Bright Future…. Thank You! 35
© Copyright 2024