Investors presentation. February 2017

Transcription

1 Investors presentation February 2017

2 Disclaimer 2 The information included in this presentation is a summary only and does not exhaust all of the information on the Company and its business, nor is it a substitute for inspection of the Periodic Report for 2015, the quarterly reports for 2016, the Company s current reports and the presentations released thereby, as reported to the ISA via the Magna distribution site. The presentation does not constitute an offering or an invitation to purchase securities of the Company, and the provisions thereof do not constitute a recommendation or opinion or substitute for the discretion of the investor. The Company is not responsible for the integrity or accuracy of the information. This presentation includes forecasts, estimates, assessments and other information pertaining to future events and/or matters, whose materialization is uncertain and is beyond the Company s control, and which constitute forward-looking information, as defined in the Securities Law, Such information may not materialize, in whole or in part, or may materialize in a manner significantly different to that forecast. Such information includes, inter alia, statements relating to our objectives, plans, and strategies; statements that contain projections of results of operations or of financial condition; statements relating to the research, development, and use of our technologies, products and product candidates; and all statements (other than statements of historical facts) that address activities, events, or developments that we intend, expect, project, believe, or anticipate will or may occur in the future. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. Important factors that could cause actual results, developments, and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things: the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which we operate; projected capital expenditures and liquidity; changes in our strategy; government regulations and approvals; litigation and regulatory proceedings. performance, or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in the Risk Factors section and elsewhere in the Registration Statement on Form F-1 filed with the U.S. Securities and Exchange Commission and in the Periodical reports (in Hebrew) with the Israeli Security Authority and the Tel Aviv Stock Exchange. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this prospectus. These forward-looking statements speak only as of the date of this presentation, and we assume no obligation to update or revise these forward-looking statements for any reason. The information presented was prepared according to the past experience and professional knowledge accumulated by the Company and in good faith. Such information is presented below for the sake of convenience only, but is not a substitute for the information provided by the Company in its financial statements or its immediate reports or in connection therewith, and therefore should not be relied on solely in itself. The information included in this presentation is similar to the information included in the reports and/or immediate reports of the Company and does not include new material information. However, some of the data included in the presentation are presented in a different manner and/or breakdown and/or are differently edited. In any event of inconsistency between the reports and/or immediate reports of the Company released to the public and the information contained in this presentation, the information released to the public as aforesaid shall prevail. All figures are approximate. These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry s actual results, levels of activity,

3 Overview 3 We are a regenerative medicine company focused on developing and commercializing products for the orthobiologics and wound care markets Our technology allows the cost-efficient production of high quality recombinant human collagen (rhcollagen) Our two lead products have received CE marking, and product launches across Europe have been initiated We entered into an agreement with Arthrex, a leading orthopedic company, for European distribution of VergenixSTR for the treatment of tendonitis We are co-developing a surgical matrix with Bioventus, a global leader in active orthopedic healing, to address a $1.8 billion opportunity in spinal surgery and trauma

4 Yehiel Tal CEO Oded Shoseyov Prof./Founder/CSO Experienced management team Regentis Biomaterials ProChon Biotech Kulicke & Soffa Industries Pauli Clean Tech CBD Tech. Fulcrum-SPD Melodea Hebrew University 4 Eran Rotem CFO Tefron, CFO (NYSE,TASE) Healthcare Tech., CFO (NASDAQ) &Gamida, CFO E&Y Ilan Belzer COO BioHarvest Procognia Ltd. Omrix Biopharmaceuticals Interpharm Nadav Orr, PhD VP R&D Ethicon Biosurgery, Johnson & Johnson Philippe Bensimon VP RA/QA/CA Maquet-Getinge 3M Medical Shomrat Shurtz Senior Director BD Protalix BBDO Proximity Clal holdings

5 Our products 5 Orthopedics Wound care Surgical Matrix Spine fusion & trauma Soft Tissue Repair Matrix Tendinopathy Wound Filler Chronic & surgical wounds Annual market potential $1.8B $2.0B $3.0B

6 Pipeline with multiple value drivers 6 Field Product candidate Indications Annual market potential Stage of development Discovery Preclinical Clinical Regulatory Commercialization Upcoming milestones Wound care Chronic & surgical wounds $3.0B Europe US Pre-IDE submission for Surgical Wounds indication Orthobiologics Tendonitis $2.0B Europe US Commercialization in EU with Arthrex Pre-IDE submission Orthobiologics CollPlant Surgical Matrix Spine fusion & trauma $1.8B US IND submission (FDA) by Bioventus 3D Bioprinting BioInk Cornea & cardiac patch Wholly-Owned Partnered

7 Recent accomplishments and planned upcoming milestones 7 Recent accomplishments: Initial distributors established for VergenixFG and sales commenced Positive clinical results of VergenixSTR VergenixSTR CE mark received VergenixSTR distribution agreement with Arthrex for pan-european sales Commenced sales of VergenixSTR Planned upcoming milestones: Sign Definitive agreement with Bioventus * Successful EU market launch of VergenixSTR (with Arthrex) Expansion of VergenixFG distribution network from 2 to 6 territories in EU Completion of EU Post Marketing Surveillance study with VergenixFG (50 subjects) Initiate FDA process (e.g. pre-ide meeting) with VergenixSTR Signing new co-development agreement with a partner (e.g. BioInk, Orthopedics) * While the co-development activity is ongoing, no license and supply agreement has been entered into and there can be no assurance that we will enter into any definitive agreement with Bioventus. In anticipation of filing an IND, Bioventus is undertaking preclinical animal studies comparing the Collplant Surgical Matrix to other active comparators, and could decide to move forward with a competing product

8 CollPlant s technology: cost effective and scalable production 8 Plant Leaves Protein Concentrate Collagen PLANTLETS IN NURSERY GROWING EXTRACTION PURIFICATION & FILLING END PRODUCT FABRICATION Low cost scalable seed propagation Low cost space Clean room facility

9 kit 9 PRP collection tube from any commercial PRP Kit Plasma Platelet-Rich Plasma Red Blood Cells

10 - Significant potential advantages over SoC Clinical trial results 10 Study Design Study Results results Single arm study 40 patients with tennis elbow (tendinopathy) One single treatment 3- and 6-month follow up End points Safety; recovery in pain and motion as measured through PRTEE, Quality of Life questionnaire and grip strength test 74% 86% of patients show clinical success at 3M of patients show clinical success at 6M 3M 48% 6M 36% 3M 74% 6M 86%

11 Future opportunity for VergenixSTR Tendon repair - injectable rhcollagen/prp matrix intended for treatment of partial or full tendon tears 11 rhcollagen-prp clot Based on VergenixSTR technology Annual US incidents: ~400K RCR 1, ACL 2, Achilles

12 kit 12

13 Clinical trial results - Full wound closure at 4 weeks after a single treatment 13 Study Design Single arm study 20 patients with lower limb ulcer One single treatment 4 week follow up End points Safety; wound reduction Study Results results Average wound closure rate of 80% Full wound closure was observed in nine of the 20 patients (45%) 90% Versus 24% of patients after 12 weeks with SoC 1 80% 70% Mean Wound Closure Rate (%) over time (N=20 patients) 80% 60% 50% 40% 62% 67% 30% 20% 30% 10% 0% Week 1 Week 2 Week 3 Week 4 1. The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of a multicenter, controlled, randomized, blinded clinical trial, Lavery et al, International Wound Journal, 2014.

14 Sales & marketing strategy: Europe first 14 Due to rapid marketing clearance, Europe offers an opportunity to accelerate revenue realization and develop a physician base of experience Utilize established distributors selling orthobiologics and wound care products across Europe in key markets Undertake Post Marketing Surveillance (PMS) studies with KOLs generate additional clinical data to support product sales and reimbursement Post Marketing Surveillance: 50+ cases to support conference presentations and peerreviewed journal submissions EMEA partnership with Arthrex extends potential for VergenixSTR beyond Europe into Middle East & African markets FDA regulatory strategy informed by European regulatory and clinical experience Establish KOL network to support EU market penetration Strategic collaborations provide pipeline and market expansion opportunities, leveraging partner infrastructure to drive adoption of rhcollagen

15 CollPlant Surgical Matrix for bone repair Collaboration with Bioventus Inc. 15 We are party to a non-binding term sheet entered into on July 2015 with Bioventus for the license and supply of the CollPlant Surgical Matrix The surgical matrix enables targeted and controlled release of BMP-2 for accelerated bone formation Applications: spinal fusion and trauma Addressable market opportunity is projected to be at least $1.8 billion (450,000 procedures*) The surgical matrix is co-developed by the companies, with our aim to sign a Definitive Agreement in FY 2017 While the co-development activity is ongoing, no license and supply agreement has been entered into and there can be no assurance that we will enter into any definitive agreement with Bioventus. In anticipation of filing an IND, Bioventus is undertaking preclinical animal studies comparing the Collplant Surgical Matrix to other active comparators, and could decide to move forward with a competing product *

16 Future opportunity: BioInk 16 rhcollagen-based BioInk for 3D bioprinting of tissues & organs Market potential: $1B+ by CollPlant s rhcollagen-based BioInk offers ideal characteristics for 3D bioprinting Biocompatible supports cell viability Controlled degradation profile Optimized viscosity and gelation kinetics Printed construct maintains physical properties compatible with natural tissue 1

17 CollPlant IP portfolio 17 Patent Name Application # Priority Date Patent Status Collagen Producing Plants and Methods of Generating and Using Same Compositions Comprising Fibrous Polypeptides and Polysaccharides WO2006/ /2004 WO /2007 Granted: USA(CIP), Europe, Europe(DIV-1), Europe(DIV-2allowed), Hong Kong,Hong Kong(DIV),Canada, Japan Japan(DIV), Australia (DIV-1), Australia (DIV-2), Mexico, China, South Africa,, Singapore, India, Israel, New Zealand. Pending: USA (DIV), Brazil, Europe(DIV), India(DIV) Granted: USA,USA(DIV-1), USA(DIV-2), USA(DIV- 3), Australia, Israel, Israel(DIV-Published), Europe Pending: USA(CON) Methods of Generating Collagen Fibers WO2011/ /2009 Pending: Europe, USA, Hong Kong Methods of Generating and Using Procollagen WO2009/ /2008 Granted: USA,Europe, Israel Pending:Canada, China(DIV), India, USA(CON) Methods of Processing Recombinant Procollagen Compositions comprising collagen and PRP for tissue regeneration WO2009/ /2007 Granted: USA, Israel, Europe WO2014/ /2013 Pending: USA, Europe, Canada, China, India, Israel Cross-linked Resilin-containing materials W2015/ /2013 Pending: USA, Europe, Canada, China, India, Israel Adhesive biopolymers and uses thereof WO2013/ /2011 Pending: USA, Europe, Israel

18 CollPlant investment highlights 18 Only viable technology currently available that can produce truly human collagen Multi-billion dollar market: innovative rhcollagen products initially aimed at orthopedics and wound healing Near-term revenues: Bioventus license milestone payments and commercialization of two lead products in Europe in 2017 Broadly applicable technology: future indications may include BioInk for 3D Bioprinting, ACL repair and surgical wounds Strong IP position Proven management team

19 February 2017