Medical Jan 2018-EN - Elbit Imaging · INSIGHTEC Overview 85+ global active ... INSIGHTEC, the...
Transcript of Medical Jan 2018-EN - Elbit Imaging · INSIGHTEC Overview 85+ global active ... INSIGHTEC, the...
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Elbit Medical Technologies Ltd. Investors Presentation
Elbit Medical
January 2018
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Legal Information This presentation includes forward‐looking information, as defined in the Securities Law, 5728‐1968, which includes, inter alia, forecasts, assessments, estimates and other information relating to future events and matters, the realization of which is uncertain and not under the control of the Company and / or INSIGHTEC LTD (INSIGHTEC) and / or of Gamida Cell Ltd. ("Gamida"). The forward‐looking information included in the presentation may not materialize, in whole or in part, or may materialize differently than expected, or may be affected by factors that can not be estimated in advance and which are not under the control of the Company and / or INSIGHTEC and / or Gamida, due to a change in one of the risk factors that characterize the Company's activity and / or INSIGHTEC and / or Gamida, as well as developments in the economic environment and external factors that affect the Company and / or INSIGHTEC and / or Gamida in their areas of activity.
The main facts and data that served as the basis for this information are facts and data regarding the current state of the Company and / or INSIGHTEC and / or Gamida and their businesses, facts and data regarding the current state of the areas of activity and macroeconomic facts and data, as known to the Company and / or to INSIGHTEC and / or to Gamida at the time of preparation of this presentation, including statistical and public data and publications published by various bodies and authorities whose contents have not been examined by the Company and / or INSIGHTEC and / or Gamida independently, and therefore the Company and / or INSIGHTEC and / or Gamida are not responsible for their correctness.In order to remove any doubt, it is clarified that the Company does not undertake to update and / or modify the information included in the presentation in order to reflect events and / or circumstances that will occur after the date of the presentation.
This presentation contains partial and selective information only, which the Company considered appropriate to share with its shareholders and the general public investing in the Company's securities. This information may not be included in the Company's financial and other reports as published to the public, or the presentation of the information contained in the presentation is different from the manner in which such information is included in such publications. This presentation contains a summary of the topics described in it, in the context in which they are discussed, and not the full information available to the Company in relation to these matters. This presentation does not include the full results and financial information of the Company and their explanations and / or the Company's business plans or the description of all of its activities, and it is not intended to replace and / or replace the need to review the reports that the Company published to the public by law, including the Company's annual and by‐annual reports and also the immediate reports (the "Reports" or "the Company's Reports"). In any case of contradiction between the data included in this presentation and the data included in the Company's accompanying reports, the data appearing in the Company's reports should be deemed binding on the Company. In addition, the Company is exposed to risk factors as detailed in the Company's reports published by law, including in the Periodic Report, which may affect the results of its operations and / or its ability to realize its plans.
Also, the company is exposed to risk factors as detailed in the company reports published to the public by law, including the periodical report that may affect the results of its activity and / or its ability to realize its plans.
This presentation should not be considered as an offer or an invitation to purchase securities of the Company. The sale of securities will be made only in accordance with a prospectus whose publication will be approved by the Securities Authority.
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17.9% )13.6%* (Company value: 160M USD According to the last investment
Business Card Elbit Medical Technologies Ltd. ("Elbit Medical") is a
public company listed for trade on the Tel Aviv Stock Exchange
Company value - NIS 270 million The Company has owner loans in the amount of NIS
150 million to Elbit Imaging, with a maturity date of January 1, 2019.
The company has two affiliated companies
24.9% )20.7%* (USD Company value: 550M According to the last investment
(and before the end of its second stage)
* Fully diluted
Holding percentage on a fully diluted basis.
An affiliate company that was incorporated in Israel in 1998, and engages in the research and
development of cell‐based medical products for the treatment of cancer and rare blood diseases
An affiliated company that was incorporated in Israel in 1999 and is engaged in the
development, production and marketing of focused magnetic imaging equipment for non-invasive treatments in tumors within the human
body using an ultrasound beam
Elbit Medical
89.2% )fully diluted –about 86% (
Using MR‐guided Focused
Ultrasound Technology, INSIGHTEC is
revolutionizing therapy by making it completely
non‐invasive
INSIGHTEC - The Future of Robotic Surgery
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INSIGHTEC Overview
85+ global active sites
168 Patents$376 million invested to date
20+ new papers expected in the next 6 months
~100 peer reviewed clinical papers
3 FDA and CE approved applications
~240 employees~$25 million of revenue in 2016
6 major new FDA indications expected by
2022
16,000+ patients treated globally
By the NumbersCompany Description
• Founded in 1999 in Israel by engineers and physicists from leading academia and medical devices industry, currently employing 240 employees
• INSIGHTEC is developing the Exablate, the first MRI-guided ultrasound-guided device to be approved by the FDA
• The first company to develop a technology that successfully targets and inserts ultrasound waves through the skull
• One technology: five markets – neurology, oncology, targeted brain drug delivery, women's health and urology
• Deep relationships with key industry players and medical academic institutions
• Global strategic partnerships with GE and Siemens
• INSIGHTEC installations at leading medical sites in U.S., Europe and Asia
• The value of the company (according to the investment round in December 2017 and before the end of its second stage) - $ 550 million
The head office is located in Haifa,
with offices in the United States,
China, Japan and Europe
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Transactions in INSIGHTEC Shares in 2017 On December 14, 2017, INSIGHTEC signed an investment agreement with Koch Disruptive Technologies, a subsidiary of Koch
Industries, Inc. (Hereinafter - "the Investor"), in the framework of which the Investor and other investors will invest in INSIGHTEC an amount of between $ 75 million and $ 150 million, in exchange for the allocation of preferred E shares of INSIGHTEC.
On December 28, 2017, the first stage of the transaction was completed, in which INSIGHTEC raised approximately $ 90 million (of which $ 75 million was received from the investor).
In consideration for the investment, INSIGHTEC issued new preferred shares of INSIGHTEC (hereinafter: the "Preferred Shares"), which immediately after their allotment constitute 19.7% of the issued share capital (and 16.5% fully diluted) of INSIGHTEC.
Following the investment and the allocation of the prefered shares, the Company holds approximately 24.9% (20.7% fully diluted) of the issued share capital of INSIGHTEC.
In accordance with the terms of the investment agreement, INSIGHTEC can increase the scope of raising up to $ 150 million
from the investor and from other investors at additional completion dates (to be implemented no later than January 31, 2018). The second stage of the investment round will be carried out at INSIGHTEC'S value of $ 550 million (assuming
full dilution). The holders of preferred shares shall have priority rights in the event of dividend distribution and material events as detailed in
the investment documents.
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• What has the second largest US conglomerate lost in Tirat Carmel?
• "This brought the Charles and David Koch empire, whose revenues are estimated at $ 115 billion a year, to invest $ 75 million precisely in the dream of INSIGHTEC, the Israeli company that develops an MRI-based treatment…"
• If you have never heard of the Koch brothers, who have recently invested in INSIGHTEC, which develops MRI-based therapy, at a value of $ 500 million, that's fine. It just means that they manage to meet their goal. Charles (82) and David (77) Koch are fanatical to their almost complete anonymity, maintaining maximum secrecy.
• The conglomerate sends arms to every area. From oil to mineral water, from fertilizer to toilet paper. Koch Industries has refineries in Alaska, Texas and Minnesota, and about 6,000 kilometers of oil pipelines. The company owns Lycra, the Brawny Paper Towels Company and the Georgia-Pacific Wood Products Company.
• The question is what has caused the empire that employs 120,000 people around the world and is estimated to have income (??? )הכנסות כמה? that INSIGHTEC attracted Koch Disruptive Technologies, Koch Industries' subsidiary, especially due to a change in its management in recent years. This became overwhelmingly American - and gave birth to the ties with the brothers.
• INSIGHTEC conducted a road show for capital raising, in which they presented their vision to institutions and investors in the US. The aim of the capital raising is mainly to finance a new direction - initial trials of injecting drugs for brain tumors, in the hope that the new management will break into this hot market.
• The road show was led by the Chairman and CEO Morris Ferré, who in his past, went through a big exit: He sold the medical robot maker MAKO (MAKO Surgical) at the end of 2013 to Stryker, one of the leading medical equipment corporation, at $ 1.65 billion.
• Koch Disruptive Technologies heard - and were impressed.
• Koch's first investment, $ 90 million, was made with other investors and was reported on December 14.
• The brothers' share was $ 75 million. The consideration: new preferred E shares, at a value of $ 460 million for INSIGHTEC.
• These investors now hold 19.7% of the company's issued share capital (16.5% on a fully diluted basis). In addition, they and existing shareholders were granted the right to invest up to an additional sum of $ 75 million by the end of January, in exchange for additional preferred shares.
From the Press ...
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Evolution of Surgery
Open Surgery Minimally Invasive Surgery Robotic Surgery Non‐Invasive
MRgFUS
CUTTING EDGE TECHNOLOGY… WITHOUT THE CUTTING
INSIGHTEC’S technology
The focused ultrasound generates heat at the focal point and destroys the targeted tissue
MRI imaging allows identification and direction to the target and real‐time monitoring of the
treatment by measuring temperatures
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The Non-invasive Future of Surgery
“It may sound like science fiction or Star Trek to some, but it isn’t. Named one of the 50 greatest inventions by TIME magazine, and credited with “changing medicine” by Fortune magazine, focused ultrasound is a new, highly disruptive, game‐changing, non‐invasive therapeutic technology that has the potential to be as revolutionary to therapy as magnetic resonance scanning (MRI) has been to diagnosis.”
MR‐Guided Focused Ultrasound In The News
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Exhalate – How Does it Work?
UltrasoundHigh intensity focused ultrasound energy generates heat at a focal point up to ablation of the targeted tissue
Magnetic Resonance Imaging (MRI)MRgFUS uses focused ultrasound to ablate the target tissue under Real Time MRI Guidance and Control
How It WorksUp to 1,000 independently controlled rays of ultrasound are transmitted to a focal point where the rays converge, transforming energy to heat, ablating the targeted tissueusing MRI to monitor treatment outcomes in real time, adjusting treatment parameters to achieve the planned result
• Interacts with an MRI system (T1.5 and T3).
• In the body system - a separate cradle for each application
A non‐invasive platform that unites two technologies ‐ high‐intensity focused ultrasound and MRI imaging
Neuro Oncology
TARGETED BRAIN DRUG DELIVERY
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Regulation Status
An initial tremor Palliative care in bone metastasis is painful
Fibroids in the womb
FDA
OncologyNeurosurgery
In addition, the company has regulatory approvals in various countries around the world.
Women's Health
Fibroids in the womb and adenomiosis
Prostate cancer
Cancerous and benign tumors in bone
Primary tremor, Parkinson tremor, and neuropathic pain
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MRgFUS Surgery Regulatory Roadmap
FDA ApprovalPivotal Study
FDA Approval510K StudyProstate
FDA ApprovalPivotal StudyFeasibility StudyBrain Tumors Ablation
FDA ApprovalFeasibility Study Pivotal StudyDrug Delivery forNeuro‐oncology
FDA ApprovalPivotal StudyFeasibility StudyLiver/PancreasClinical Research
FDA ApprovalPivotal StudyFeasibility StudyEpilepsy Clinical Trials
2017 2018 2019 2020 2021 2022
Parkinson’s Disease
NEU
ROLO
GYONCO
LOGY
FDA ApprovalFeasibility Study Pivotal StudyDrug Delivery forOncology Indications
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Large US Neuro Market Opportunity
~122,000 POTENTIAL US
PATIENTS
Patient Population MRgFUS Potential Annual Patients
Essential Tremor
Prevalence 7‐10MIncidence 70KRefractory 10%
50,000
Parkinson’s Disease
Prevalence 1‐ 1.5MIncidence 60KRefractory 40%
25,000
EpilepsyPrevalence 2.2M,Incidence 150K. Refractory 30%
22,000
Brain Tumors Incidence / Prevalence 250,000 patients 25,000
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Expanding Global Presence
INSIGHTEC has direct and indirect sales presence in key regions globally and is growing
Miami
DallasTirat Carmel Shanghai
Tokyo
HeadquarterOfficesNeurosurgery Treatment Center
Women’s Health Treatment CenterOncology Treatment Center
Rome
Americas24 USA2 Canada1 Mexico1 Brazil
Europe4 Germany11 Italy2 UK2 Switzerland2 Spain1 Poland3 France
Asia 10 Japan4 Korea8 China2 Singapore1 Taiwan1 Malaysia2 Australia4 India1 Vietnam6 Russia1 Kazakhstan2 Israel1 HK
The company's appliances are deployed in 120 of the world's
leading medical centers
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168
Strong & Comprehensive IP
+ Strong IP and comprehensive patent protection of technology portfolio
+ Patent portfolio constitutes a significant barrier to entry for competitors
+ On-going intensive innovation pipeline
Approved Patents
Submitted applications in process of approval
Patent applications in development
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Extensive Barriers to Entry
Development Costs
IP Protection
Regulatory Approval
+ Significant time and money spent on clinical trials+ Very long lead time for clinical trials and approval cycles+ Only company to have neuro regulatory approval + In advanced trials for other applications
+ $285 million spent on development over 18 year period, including $48 million since 2014
+ Very complex technology that takes years to develop with highly specialized technical skills
+ IP protection on 18 years of technology development+ 168 approved patents to date
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Experienced Management Team
• Seasoned medical device executive
• Previously, Chairman of the Board and CEO of MAKO Surgical Corp.
• Doctor of Medicine and Master of Public Health
• The visionary behind MRgFUStechnology
• Previously President of Diasonics and Elbit Medical Imaging
• PhD in Electro Optics and BSc in Electrical Engineering
MAURICE R. FERRÉ, MD CEO & Chairman of Board
KOBI VORTMAN‚ PHD Founder & Vice Chairman
of the Board
EYAL ZADICARIO, PHDGeneral Manager
JUN (JIM) TAOCCO
NADIR ALIKACEM‚ PHDVP Global Regulatory
Affairs & CRO
RONI KARIEVP and CFO
• Leader of the MRgFUS R&D team
• Experience with R&D of multi‐disciplinary technology
• PhD in Computer Science and BSc in Aeronautical Engineering
• Broad experience in business strategy with private equity firms and GE
• Previously VP of Strategy & BusDev at Constellium
• MBA and MSc in Material Engineering
• Expert in regulatory strategy
• Previously Asst. Professor at UT Southwestern Medical Center and Scientist at Saint Francois’ D’AssiseHospital
• Postdoctoral fellowship, PhD& MSc in Physics
• Experienced Finance Executive
• Previously CFO at Diagnostic Tech, Finance Manager at NetManage & Controller of Elbit Group
• CPA, BA in Economics & Accounting
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Shareholders and Scope of Investments in INSIGHTEC
To date, INSIGHTEC has invested $ 376 million in its shareholders
Elbit’s group investment in INSIGHTEC
amounts to about $ 116 million 20.7%
21.3%
13.7%
7.4%
4.6%
6.9%
3.4%
3.4%
18.6%
Ownership structure (fully diluted(
ELBIT Medical
York Fund
Koch
Exigent
GE Group
M Ferre Group
GEOC
MTA group
Others
Development of biotechnological
products based on cells
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Gamida Cell – A World Leader in Stem Cell Therapy
An ambitious clinical development program, backed by adequate financing and an experienced management team
Gamida Cell is engaged in the development of products for curing cancer and rare genetic diseases.
The company has developed several products based on NAM technology platform for cell proliferation:
NiCord® ‐ a treatment for hematological malignancies
• Efficiency and safety: Good results in Phase II trials - rapid and effective engraftment, and improved transplant results.
• Production capacity and technology transfer under GMP conditions
• A “Breakthrough Therapy” designation granted by the FDA• An "Orphan Drug" designation was granted in the United
States and Europe• A Phase III trial has commenced (appr. 120 patients)
CordIn ™ - a treatment for rare hematological disorders
Efficacy and safety: Promising initial results in a Phase II trial in sickle cell anemia; Phase I trial in aplastic anemia
NK cells product – A clinical trial has begun for the treatment of blood cancers in the United States
Major shareholders • Novartis• Elbit Medical • CBI
Company value • Company value according to the last investment round in July
2017 - $ 120 million (before the money).
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Investment Round in Gamida Cell
On July 9, 2017, an investment round of $ 40 million ("the investment") was completed at Gamida Cell Ltd. ("Gamida Cell") at a value of $ 120 million (before the money), led by Shavit Capital Fund, to which Novartis and other investors, including VMS Investment Group, Israel Biotech Fund, IHCV and ClalBiotechnology Industries Ltd. (the "Investors"). In return for the investment, prefered shares were allotted to the investors ("the allotted shares") at a value of $ 120 million (before the money) to Gamida Cell. In addition, investors were granted options to purchase preferred shares in a quantity constituting 60% of the number of shares allotted (the "Options"). The exercise price of the options is 120% of the price per share paid by the investors on the closing date of the transaction. The options may be exercised during a period of up to 5 years from the closing date of the transaction. Upon completion of the investment, the Company holds 17.9% of Gamida Cell (13.6% fully diluted).
Gamida Cell has raised $ 135 million so far.
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NiCord®-Area of Activity and Scope of the Target Market
Bone marrow transplantation in patients with leukemia has been an accepted and life-saving treatment for
50 years…
Every year about 70 thousand patients are candidates for bone marrow transplant from a donor (about
40,000 in the US, Europe and Japan).
In practice, bone marrow transplants are performed only in about 40,000 patients.
About 30,000 patients are left untreated each year, the main reason being that they have no suitable donor
in time.
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Over 800,000 cord blood units are frozen in public blood banks around the world
NiCord® -Cord Blood as an Alternative to Bone Marrow Transplantation
There is no need for a complete tissue matching
with the patient
Readily available using a computerized system
of cord blood banks
Pitfalls in cord blood plantation:Benefits of Cord Blood Transplantation:
A small amount of stem cells
Slow engraftment results in poorer clinical
outcomes
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NAM-A Unique Technology for the Enrichment of Cord Blood in Stem Cells
Cord Blood GMP Production site at the Company's facility in Israel
Enrichment of stem cells in culture with
Gamida's unique technology
NiCord® shipedfrozen to hospitals
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NiCord® -Treatment of Malignant Diseases of the Circulatory System
NiCord® is based on cord blood stem cells enriched with NAM technology.
Results from Phase I / II were presented at the ASH 2017 Annual Meeting.
Phase III for NiCord® has commenced in the USA, Europe and Asia. Appr. 120 patients will be treated in an open,
randomized and controlled trial.
The control group - patients who underwent transplantation in one or two non-enriched cord blood units.
A primary endpoint for the trial-time for engraftment.
Primary endpoint results of the study and BLA submission- 2020.
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CordIn ™ -Treatment of Non-malignant Blood Diseases Sickle cell anemia is a life-threatening blood disease caused by a genetic defect in the production of hemoglobin.
The incidence of diseases is high in the Mediterranean, China, India, Asia, and the African-American population. The
number of sick persons in the United States is about 100,000.
The average life expectancy of these patients is about 50 years.
The cost of treating these patients in the US is estimated at more than $ 8 million over a lifetime.
There are few treatments that treat the symptoms of the disease but do not cure it. Bone marrow transplantation was
proven to be a complete cure for patients.
Gamida Cell has been applied in 12 patients so far. Positive initial results were published at ASH 2016.
Recruitment of patients continues.
Beginning of I / II Phase II trial in patients with aplastic anemia and myelodysplastic disease with CordIn ™. The trial
will be conducted in the United States and is expected to recruit up to 29 patients between the ages of 4 and 55, the
first patient successfully treated.
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NiCord® Provides Significant Benefits to Patients, Hospitals and Payers
Patients• Better clinical results• Rapid hematopoietic and immunity recovery• Reduced morbidity
Hospital• Shorter hospital stay - 10 - 20 days• Improved efficiency in beds utilization (census), allows more patients to get to transplant• Savings in resource exploitation• Additional budget for the implant itself is available in many cases
Payer• Reduced treatment charges
• NiCord® requires only 1 CB unit$
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Gamida Cell Pipeline
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An Experienced Management Team
Has more than 20 years of experience in research, development, registration, and launch of hematology and oncology drugs. Previously served as the VP and Head of Global Medical Affairs at Pfizer Oncology.B.A. from Johns Hopkins University and an M.D. from New York University School of Medicine.
RONIT SIMANTOV, M.D.CHIEF MEDICAL OFFICER
TONY PELEDCHIEF SCIENTIFIC OFFICER AND VICE
PRESIDENT OF R&D
YAEL MARGOLINPRESIDENT
JULIAN ADAMS, PH.D.CHAIRMAN & CHIEF EXECUTIVE OFFICER
Co‐founder of the company and the researcher whose discoveries have led to Gamida Cell’s key clinical achievements, which are supported by many patents.Previously served as a scientist at the Hematology Department, Hadassah University Hospital, Jerusalem, Israel and has more than 15 years of experience in hematopoiesis and stem cell research.
Has more than 35 years of experience in the venture capital, pharmaceutical and biotech industries.Served as CEO of Gamida Cell from 2005‐2017. During this time, she led Gamida Cell from pre‐clinical development through phase 3 international registration studies, the receipt of a Breakthrough Therapy Designation for the company’s lead product, strategic collaborations and the raising of $100 million from various financing initiatives.Served as vice president of Denali Ventures LLC, a healthcare specialized venture capital firm, and a program manager at TevaPharmaceuticals.Holds a Ph.D. in Biology from the Weizmann Institute of Science and was a post‐doctoral associate at the Yale University School of Medicine.
Has more than 30 years of experience in drug discovery and development with a strong focus on cancer research.Previously served as chief scientific officer and president of Clal Biotechnology Industries.Has won several awards for his drug development efforts throughout his career.Received a B.S. from McGill University and a Ph.D. from the Massachusetts Institute of Technology. He also earned a Doctor of Science, honoris causa, from McGill University.
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Goals for the Coming Years
CordIn ™Phase II (Hemoglobinopathies)results
NiCord ®phase III begin
NiCord ®Phase III results
Clinical
NK Cellsphase I/II begin
2017 2018 2019 2020
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Shareholders and the Scope of Investments in Gamida Cell
To date, Gamma Cell has invested about $
135 million.
The Elbit Group's share in the investment is
$ 15.7 million
13.6%
17.9%
14.3%
9.0%8.7%
8.7%
18.1%
9.8%
Ownership structure (fully diluted)
Elbit Medical
Novartis
CBI
IHCV
Shavit
VMS
Others
ESOP
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Main Achievements of INSIGHTEC and Gamida
2017/4 INSIGHTEC-FDA
approval for treatment of
significant tremor
2017/7 Gamida-Raising $
40 million at a market value of $
120 million (before the
money(
2017/8 Gamida – Trial
commencement for CordIn™ in aplastic anemia
patients
2017/10 INSIGHTEC-FDA
approval to begin Phase III study using
the brain system
2017/12 INSIGHTEC-
Completion of the first stage of an
investment transaction in
which INSIGHTEC raised
approximately $ 90 million.
2017 בשנת
11/2017Gamida – CEO appointment
and opening of office in USA
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Thank You!
Elbit Medical
January 2018