November 2015
Elbit Medical Technologies Ltd. Company Presentation
Disclaimer
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• This presentation is proprietary to Elbit Medical Technologies Ltd. and its affiliates (collectively, “Elbit” or the “Company”) and contains confidential information.
• This presentation is intended only for use by the person (the “Recipient”) to whom it has been directly presented, addressed or delivered for the sole purpose of
evaluate a possible transaction or transactions. The information contained in this presentation (in whole or in part) shall be held by the Recipient in strict confidence,
and may not be passed, distributed, disseminated and/or copied by the Recipient without the prior written consent by Elbit.
• This presentation does not constitute a proposal and/or an offer and/or invitation to acquire and/or to be issued shares of Elbit.
• This presentation has been prepared to provide summary information to Recipient, but it does not, however, purport to present all material information regarding
Elbit, and it is not a substitute for a thorough due diligence investigation by any Recipient. In particular, Elbit makes no warranty, representation assurance, or
inducement, express or implied, as to adequacy, sufficiency, or freedom from defect of any kind of information contained herein.
• The information contained herein might not be included in the financial or other statements issued by the Company as published or that its manner of presentation in
this presentation is different than the manner in which this information is included in the aforesaid publications. This presentation does not include the entire results
and financial information of the Company and notes thereof, and/or the Company's business plans or a description of its entire activities, and it is not intended to
supersede and/or replace the need to review reports and statements published by the Company in accordance with the provisions set forth by law including, the
Company's Annual Report for the year ending on December 31, 2014 (hereinafter, the “Annual Report" and jointly with other published reports, statements and
announcements issued by the Company, the "Reports" and/or the "Company's Reports"), and the full financial statements of the Company included therein.
• Any forward-looking statements in this presentation include statements regarding the intent, belief or current expectations of Elbit about its business, financial
condition, results of operations, and the condition of our properties. Actual results may differ materially from those projected, expressed or implied in the forward-
looking statements as a result of various factors. Any forward-looking statements contained herein speak only as of the date hereof, and we caution the Recipient not
to place undue reliance on such statements. Such forward-looking statements do not purport to be predictions of future events or circumstances, and therefore, there
can be no assurance that any forward-looking statement contained our releases will prove to be accurate. We undertake no obligation to update or revise any
forward-looking statements.
• In any event of discrepancy between information contained in this presentation and the information contained in the Company's Reports and/or financial statements
attached thereto, figures contained in the Company's Reports shall be deemed as obligating the Company.
Business Card
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Elbit Medical Technologies Ltd. (“Elbit Medical”), is a publicly traded company on the Tel Aviv Stock Exchange.
The Company has significant holdings in 2 promising companies: InSightec and Gamida Cell
•InSightec – associated Israeli company founded in 1999, develops and distributes the Exablate platform which provides non-
invasive treatments for a variety of oncology, gynecology and neurology indications. The Exablate platform uses revolutionary
MRgFUS technology which combines high intensity focused ultrasound guided by Magnetic Resonance Imaging (MRI) to thermally
ablate tumors inside the body.
•Gamida cell - associated Israeli company founded in 1998 , and is engaged in the development of stem cells therapeutics, sourced
by blood from the umbilical cord (“umbilical blood”) .
Elbit Medical is a subsidiary of Elbit Imaging Ltd. The main shareholders of Elbit Imaging are: York Capital - approximately 19.7 %, and DK PARTNERS - approximately 14.3 %.
(86.2% )89.9%
(23% )25% (30% )36%
Elbit Imaging
Elbit
Me dical
Insightec Gamida
Cell
Elbit Medical
COMPANY OVERVIEW
THE GLOBAL LEADER OF MRgFUS
INSIGHTEC develops the world’s foremost
MR-guided Focused Ultrasound treatment
platform for a variety of neurosurgery,
oncology and gynecology indications.
Treatments are totally non invasive, safe
and effective, and are performed in
ambulatory setting
COMPANY PROFILE
INSIGHTEC is a privately held Israeli company founded in 1999
~160 employees worldwide
Developed ExAblate® - the first FDA approved therapeutic device using MR-guided Focused Ultrasound
First to develop technology to successfully steer and focus ultrasound through the cranium
Headquartered in Haifa, Israel. Regional offices in US, China, Japan and Europe.
Non invasive therapy platform that combines two proven technologies - High intensity focused ultrasound and Magnetic Resonance Imaging.
The high intensity focused ultrasound (FUS) generates heat at the focal point to ablate the target tissue.
The MRI enables 1) to identify and target 2) to monitor in real time the treatment progress using thermometry information
INSIGHTEC’S TECHNOLOGY
www.insightec.com 7
3 PRODUCT FAMILIES
Neurosurgery Oncology Women’s Health
INSIGHTEC PRODUCT ROADMAP – NEUROSURGERY
2010
Larger volume treatments Whole brain treatment envelop Pathologic tissues (at MR) Thermal ablation & Targeted Drug
Delivery
Small volume treatments Deep central structures treatment
envelop Normal tissues (at MR) Thermal ablation
Neuro- Modulatio
n
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2016+
Targeted Drug
Delivery Alzheimer
Epilepsy Brain Tumors
Parkinson's
Disease
2015
Essential Tremor
2012
Neuropathic Pain
2010
INSIGHTEC PRODUCT ROADMAP – BODY/ONCOLOGY
2010
Larger volume treatments Faster treatment rate Treatment of moving organs Non-heating properties of US
Outpatient, low risk profile Real time close loop personalized
therapy Tumors’ conformal treatment Pathologic tissues (based on MR)
Targeted Drug
Delivery
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2016+
Pancreas Liver Prostate
2015
Facets
2013
Bone Tumors
2012
Gynecology
2004
Treatments for uterine fibroids
Single-session, outpatient treatment
Uterus preserving
Future fertility
Minimal complications and adverse events
Durable as other uterine sparing treatments’ alternatives
Treatments for pain palliation of bone metastases
Single-session
Non-ionizing
Minimal complications and adverse events
Very fast post procedure pain relief
Treatments for Essential Tremor, Tremor dominant Parkinson’s Disease, Neuropathic Pain
Single session
Noninvasive procedure
No ionizing radiation
No penetrating trajectories with probes
No implantable hardware
No anesthesia
No infectious risks
*Currently under investigation: FDA pivotal study G120246
• Embedded phased array ultrasound transducer (200 to 1,000 independently controlled transducers)
• Real time treatment monitoring
• Interchangeable cradles for multiple applications
• Interfaces with GE MRIs (1.5T and 3T scanners)
OUR TECHNOLOGY EXABLATE BODY PLATFORM
• 1000 element spherical phase array transducer
• Sharp boundaries between treated and untreated areas
• Focal point controlled electronically in size (2-5mm) and location (<1mm accuracy)
• Real-time MR monitoring of temperature
• Interfaces with GE MRIs (1.5T and 3T scanners)
OUR TECHNOLOGY EXABLATE NEURO PLATFORM
OUR TECHNOLOGY EXABLATE SOFTWARE
• Treatment planning while recognizing and avoiding sensitive tissue
• Real-time treatment outcome monitoring using MR thermometry
• MRI based real time motion detection and compensation in treatment plan
REGULATORY STATUS
NEUROSURGERY*
Essential tremor
Tremor dominant Parkinson’s Diseases
Neuropathic pain
*Currently under investigation: FDA pivotal study G120246 **Pain palliation of bone metastases P110039 ***For the treatment of symptomatic uterine fibroid treatment, P110039
ONCOLOGY
• Pain palliation of bone metastasis
• Primary bone
tumors • Bone
metastasis
WOMEN’S HEALTH
Uterine fibroids (Future fertility) Uterine fibroids & Adenomyosis (Future fertility)
Commercially approved in Japan, Australia, China, Korea and Russia
OUR GLOBAL FOOTPRINT
18 USA 2 Canada 1 Mexico 2 Brazil
Americas (23%)
4 Germany 11 Italy 4 UK 2 Switzerland 1 Spain 1 Poland 3 France 1 Czech Republic
Europe (27%)
14 Japan 4 Korea 5 China 2 Singapore 1 Taiwan 1 Malaysia 2 Australia 7 India 1 Vietnam 2 GE 17 Russia 1 Kazakhstan 3 Israel 1 HK
Asia (50%)
An install base of ~120 sites around the globe, our customers include well-renowned centers of excellence
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Gamida Cell Immune Therapy Technologies November 2015
Gamida Cell – An Immuno Oncology Company
Gamida Cell is focused on the use of stem cells and NK cells for the treatment of orphan hematological diseases and malignancies NiCord® - a treatment for hematological malignancies. Phase III is planned to begin in mid 2016 CordIn™ - a treatment for sickle cell disease and thalassemia; A study in aplastic anemia to begin in 2016 NK cells for immune therapy of cancer, in advanced preclinical development. Two phase I/II studies will begin in 2016 NiCord orphan drug designations:
⁻ AML, ALL, MDS and Hodgkin Lymphoma in the US; ⁻ AML in the EU (request for additional indications in US and EU will be submitted)
GMP manufacturing facility on site Broad worldwide patent portfolio Key company facts
- Founded – 1998; Headquarters – Jerusalem, Israel - Employees – 41 (35 in research and development, including 7 PhDs/MDs) - Main shareholders: Novartis, Elbit Imaging, Clal Biotechnology Industries (CBI),
Israel Healthcare Ventures (IHCV), Teva Pharmaceuticals, Auriga Ventures, Denali Ventures
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Relationship with Novartis
In 2014 Novartis invested $35MM in Gamida Cell, for 15% in equity and an
option to acquire the company
In October 2015 Novartis signed an agreement for an additional investment of
$15m:
- $5m immediate investment, for additional ~2.5% equity
- $10m to be invested as participation in future financing of Gamida Cell,
pending several conditions
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Product Research Pre-Clinical Phase I/II Phase III
NiCord®
CordIn™
Natural Killer Cells
Dendritic Cell Vaccine
Hematological Malignancies
Refractory Leukemia
Products in Development
Sickle Cell Disease; Thalassemia
Aplastic Anemia
Immune Therapy for Cancer
Immune Therapy for Cancer
NiCord® Target Market in Hematological Malignancies(1-4)
Hematopoietic stem cell transplantation is a life saving treatment for patients with high risk leukemia or lymphoma. In clinical practice for >45 years
~70,000 patients each year are in need of an allogeneic (donor derived) bone marrow transplantation (35,000 patients in the US and EU combined)
⁻ 20% of patients are getting a transplant from a family related donor
⁻ 20% of patients are getting a graft from an matched unrelated donor. Search takes time, many of the patients cannot wait
⁻ ~10% of patients are getting an alternative/investigational transplant, including: haplo donor, umbilical cord blood (single or double units), mismatched unrelated donor
⁻ 50% of patients are not getting a transplant
The number of patients indicated for transplantation grows annually by 5%
NiCord can address the need of 56,000 of these patients (28,000 in the US and EU combined)
(1) http://globocan.iarc.fr (2) Company estimates based on CIBMTR,EBMT reports, (3) Song Yao, Biology of blood and marrow transplant, 2012 (4) Navneet S. Majhail Biology of blood and marrow transplant,2013 23
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Planned to begin in mid 2016
120 patients with high risk hematological malignancies:
AML, ALL, MDS and CML
Randomized controlled study, comparing NiCord® to un-manipulated cord (60 patients
in each arm)
Follow-up: 1 year
Expected time of recruitment: 2 years
FDA and EMA have agreed to the study design outline
End of phase II meeting with the FDA and a follow-up meeting with the EMA are
planned for November 2015
NiCord® Phase III
NiCord® Clinical Data Summary (update April 22, 2015)
Treated in 6 different hospitals in the US and Europe
Cryo-preserved formulation is comparable to the fresh formulation
Rapid and robust engraftment of neutrophils
Rapid and robust recovery of platelets
Low morbidity (acute and chronic GvHD, relapse, infections)
Shorter primary hospitalization and less re-admissions
Improved 2 year survival : higher overall and disease free survival, less treatment related mortality
23 NiCord patients (combined pilot and phase I/II studies)
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Clinical Factors of Interest Peripheral Blood Cord Blood NiCord®
Availability of a graft 50% of pts (3m) 95% of pts (1w) 95% of pts (4w)
Time to Engraftment 14 days 22-24 days 11 days(1)
Severe acute GvHD High Moderate Low
Extensive chronic GvHD High Moderate Low
T cell reconstitution (CD4) Day 100-180 Day 180-360 Day 100-180
Alive and out of the hospital, in the first 100 days
~ 75days ~ 54 days ~ 76 days (1)
TRM (2 years) 20% 35% ~10% (1)
Disease Free Survival (2 years) 50% 50% ~70% (2)
NiCord® Target Product Profile
(1) Based on 23 patients treated in a pilot and a phase I/II studies (2) Based on Pilot study only, as follow-up in the phase I/II study is not long enough
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NiCord® Pricing Considerations and Reimbursement Assumptions
Shorter hospitalization of patients transplanted with NiCord: ~20 days saved compared to unmanipulated cord transplantation; comparable to peripheral blood transplantation
Reduced morbidity (infections, relapse, GvHD) results in reduced resource utilization per patient
Improved efficiency in hospital resources and beds
Transplantation of “no option” patients
One time treatment which is life saving
NiCord is a stand alone product
Cost of a cord blood unit is $ 45K. The clinical standard in cord blood transplantation is using two units ($ 90K)
Codes for reimbursement are available for hematopoietic cell transplantation
Reimbursement in the US is by case rate
Average reimbursement $ 200-300K. With many payers the graft source will be a carve out, and reimbursed separately
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NiCord® Market Potential
Potential market of >56,000 patients worldwide (>28,000 in US and EU)
High penetration expected in the “no option” patients who are not getting a transplant, and in patients treated with alternative/investigational grafts: mismatched bone marrow, haplo identical donor, unmanipulated cord.
Slower penetration in patients who end up getting a transplant from a matched unrelated donor
Price assumptions (additional research ongoing): $ 100 – 200K
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CordIn™ for Non-Malignant Orphan Diseases
Gamida Cell developed CordIn, a variation of NiCord®, adapted for transplantation in patients with chronic non-malignant diseases
CordIn is being developed under a separate IND
The differentiation between NiCord and CordIn will allow different pricing
CordIn is currently being tested as a potential cure for sickle cell disease and thalassemia (see next slide)
CordIn will be tested in additional non-malignant, chronic orphan indications, such as: bone marrow failure syndromes, genetic metabolic diseases and refractory autoimmune diseases
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Sickle Cell Disease and Thalassemia Genetic blood disorders
Orphan indications
High morbidity, low life expectancy
Symptomatic treatments are available. The cost of treating a patient with SCD is approx. 9 million USD over their life time http://www.cdc.gov/Features/dsSickleCell_MedicalCosts/
The only known cure is hematopoietic stem cell transplantation
CordIn™ - Market Potential
Sickle Cell Disease (SCD): 100,000 patients in the US (1)
⁻ Estimated 4,400 - 8,600 SCD patients are potential CordIn users
⁻ The cost of treating a SCD patient over their lifetime is $ 8-9M
⁻ Estimated price per patient (additional research required): $ 250 – 500K
Thalassemia: 200,000 patients worldwide (1)
⁻ Estimated 6,000 thalassemia patients are potential CordIn users
Aplastic anemia: 200,000 patients in the US
⁻ 300 - 600 new cases each year
Additional indications:
⁻ CordIn is being developed to address the unmet medical need in additional
indications such as genetic metabolic diseases; refractory autoimmune
diseases; bone marrow failure syndromes
(1) Data for SCD and thalassemia are based on Trinity Partners research for
Gamida Cell, July 2013
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Manufacturing Capabilities
NiCord® and CordIn™ are currently manufactured in our own GMP suite in Gamida Cell. Manufacturing will be expanded to a CMO to accommodate the recruitment needs during phase III. A self owned central manufacturing site is planned for the commercial phase
Successful and full transition from a fresh to a cryo-preserved formulation of both NiCord and CordIn
Manufacturing processes are robust and reproducible
Very low COGS compared to industry standard for “batch per patient” cell products
Additional optimization is in development to further reduce COGS
Cost effectiveness with the cryo-preserved formulation: allows central manufacturing for worldwide distribution
Gamida Cell’s proprietary products were developed internally: full transition from R&D to GMP manufacturing scale including testing and release was performed internally at Gamida Cell
Successful technology transfer process was performed to a CMO and managed by Gamida Cell
A logistics infrastructure was carefully established, ensuring delivery of the products to clinical sites all over the US and Europe, with no failures or delays
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Elbit Medical
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Capital Structure & latest investment rounds
Elbit Mecical – Market Cap and Shareholders Loans
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Total debt as of 30.09.2015 Interest linkage Repayment date Early Repayment Posibility
NIS 84 M 6% USD 31.12.2017
After 1.10.2016, possibility of early repayment
(without penalty), subject to approval of
independent directors committee
NIS 53 M No interest
Israeli Consumer
Price Index 31.12.2017
After 1.4.2016, possibility of early repayment
(without penalty), subject to approval of
independent directors committee
NIS 7.5 M
Management
fees debt
Not linked and no
interest 31.12.2017
After 1.4.2016, possibility of early repayment
(without penalty), subject to approval of
independent directors committee
Total of NIS 144.5 M
Loan Repayment Terms
(*) charge from Elbit Imaging Ltd. For management service to the company.
• Elbit Medical Market Value in the Tel Aviv stock Exchange is approximately NIS 165 Million.
• Elbit Medical has been provided with shareholders loans from Elbit Imaging( the parent company) in the total amount of approximately NIS 145 million as specified below:
Insightec - Latest investment rounds
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• Since June 2014 and until today, total of USD 62.5 million were invested in InSightech, at pre-money valuation of USD 200 million. Out of this amount, York Capital ( Major Shareholder of the Parent Company) invested approximately USD 44 millions, and Chinese group (“GEOC”) invested USD 12.5 million, in exchange for 16% and 4% in InSightech’s share capital, respectively (on fully diluted basis).
• On March 2015, GE York Capital, other shareholders of InSightec and certain other purchasers, of the second part (the "Purchasers"), have signed and executed an agreement for the sale of 6 million Series C Preferred Shares of InSightec held by GE, which constitutes approx. 4.2% of InSightec's share capital on a fully diluted basis, at a price of $1.50 per share. Furthermore, the agreement grants the Purchasers an option to purchase 12 million additional Series C Preferred Shares from GE, which represent approx. 8.5% of InSightec's share capital on a fully diluted basis, for the same price ($1.50) within one year of the closing date of the transaction.
• Till today InSightech’s main shareholders invested total of $262 million:
o Elbit - $116 M
o GE - $72 M
o York Capital - $44 M
o GEOC - $12.5 M
o MTA - $17 M
¹ In the event that InSightec's aggregate revenues for 2014 and 2015 as reflected in its annual audited financial statements for such years are less than $60 M, the Series D price per share will be adjusted proportionately and the Investor and Subsequent Investors shall be issued additional Series D Preferred Shares, provided, however, that the price per share shall not be reduced by more than 8%.
30%
22% 19%
4%
4%
21% ELBIT Group
GE group
York Fund
GEOC
MTA group
Others
Gamida Cell - latest investment round
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• in August 2014 Gamida Cell’s shareholders (including Elbit Medical), completed the execution of the Option and Investment Agreements (the "Agreements") with Novartis Pharma AG (“Novartis”).Under the Agreements, Novartis invested $35 million in Gamida Cell in exchange for approximately 15% of Gamida Cell’s share capital and an option to fully acquire Gamida Cell from the other shareholders, including Elbit Medical, for a cash payments of approximately $165 million and potential future payments of up to $435 million, depending on certain milestones.
• On June 3, 2015 Novartis representative has notified Gamida Cell that, although Gamida Cell has successfully met
all of the determined milestones, Novartis does not intend to exercise the Option. At the same time, it was further stated that Novartis was interested in continuing to collaborate with Gamida Cell in the development of its products, and will soon explore suitable alternatives with Gamida Cell.
• In October 2015 Gamida Cell has entered into agreement with Novartis, which consists of the following material agreements :
In the framework of the Agreement , Novartis invested in Gamida an immediate amount of $5 million in return for approximately 2.5% in Gamida on a fully diluted basis. Following this investment Novartis will then holds approximately 18% in Gamida on a fully diluted basis. In addition, in the event that by the end of 2017 Gamida shall raise the minimum remaining funding required to cover the Phase III study of NiCord, by way of an equity investment, Novartis will invest in Gamida, subject to certain conditions set in the Agreement, an additional amount of up to US$ 10 million.
Gamida Cell - latest investment round
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o As of today an amount of approximately $95 million has been invested in Gamida, Elbit’s share in the investment is approximately $15.7 million.
23%
16%
14%
5%
18%
10%
14%
Holding chart (fully diluted)
Elbit medical CBI IHCV Teva Novartis ESOP Others
Thank you
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