Download - HBL Financing 7.08
Hadasit Bio-Holdings Ltd. – “HBL”
((Tel Aviv Stock Exchange: HDST
July 2008
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Forward Looking Statements
This document/presentation contains forward looking statements. Words such as “estimates,” “expects,” “intends,” “plans,” “believes” and terms of similar substance used in connection with any discussion of future operational performance or financial results, identify forward looking statements.
Such statements are subject to risks and uncertainties that could cause the actual results to differ materially from these statements. The forward-looking statements contained herein speak only as of the date of this document.
The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with regard thereto or to reflect any change in events, conditions or circumstances on which any such forward-looking statement is based, in whole or in part.
This document does not constitute or form any part of any offer or invitation to sell, or any solicitation of any offer to purchase or subscribe for any shares in Hadasit Bio-Holdings Ltd. or any of its affiliated entities nor shall it form the basis of, or be relied on in connection with, any contract therefore.
The Value Chain in Israeli Biotech The Value Chain in Israeli Biotech
Academy & TTO’s
Incubation Govt. Support
ClusteringSpecialized
Angels & VC’s
PublicInvestment
Co.
Strategic Partnering
Yeda
Yissum
Ramot
BG Negev
Hadasit
Meytav
Rad-BIO
Naiot
Capital- Point
OCS
Magnet
BIRD
Bio-Disc
BriTech
Bioline
Biomedix
HMO Bio-Park
Ofer HT
Glenrock
Coronis
Pontifax
BioLight
Clal Bio
Maayan HBL
July 2008
Support: GMP, Regul., CRC, Underwriting, IPOs, PR/IR, Analysis, Market-making,
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HBL - Company ProfileHoldings in early-stage biotech companies (until completion of Phase I)
• 10 companies – All IP developed at Hadassah • 3 areas (Oncology, Auto-immune diseases, Tissue engineering / Stem cells)
• Criteria – Demonstration of Proof of Concept, Blockbuster Market • Exit strategy - at end of Phase I
Leveraging Hadassah Hospital • Source of Intellectual Property and future investment opportunities • Skilled personnel, infrastructure, GMP facilities and clinical trials
• Established: September 2005 • Traded: Tel Aviv Stock Exchange (HDST) – since January 2006• Investment rounds:
• IPO (January 2006) – $ 8 m • Convertible Bonds (August 2006) – $ 10 m , $ 5 m converted (Feb. 2007)• Strategic Investment (May 2007) - $ 2 m (Consensus Business Group)
• Stockholders: Hadasit (owned by Hadassah) (52%), public (43%), CBG - (5%)
VertoVertoCell CureCell Cure ProtAbProtAb KAHRKAHR
100%100%
52%52%
H.B.L Ltd. H.B.L Ltd.
Public 43%Public 43%
TolarexTolarex
75%34% 100% 80% 92%
Auto-immune Disease
ForticellForticellBio.Bio.
(Nasdaq)(Nasdaq)
4.5%
Tissue Engineeringand Stem-cell Medicine
IncureIncure TK SignalTK Signal(UK)(UK)
66% 25%
Oncology
22%
Thrombo Thrombo techtech
C.B.G 5%C.B.G 5% ConjuGateConjuGate 30%
Drug Engineering
HBL Structure (7/08)
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4 Key Building Blocks – “F.I.M.S”
Finance I.P. Mgt. Space
IPO
Bond
PIPE - CBG
OCS
Venture Philanthropy
FP7
NIH
Hadassah
50 new Patents per
year
Partnering
Heb.U.
U.PENN
Experienced Managers
All HMO Experts
Seasoned Pharma + VC Execs.
Ph.D’s / M.D’s
“Bio-Park”:
6 floors of 1,500 m2 o
Fully customized for
Biotech companies
GMP, GLP, Animal
facilities, Phase I center
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2008 – Value Adding Milestones
KAHR – HBL Investment, 5 New Compounds from UPENN, OCS approval for $ 400 K, new VP, external investment
Tolarex – HBL Investment, IND approval from FDA, Phase I start, external investment
ProtAb – Completion of humanization – external investment TK Signal – Preparation for Phase I, Phase I start Verto – Completion of Phase I trial, strategic partnership Incure – Expansion of trial data, Exit via strategic partnership ConjuGate – External Investment, Manuf., Phase I start BiolineRx – 2 X Phase II completions (BL1020, BL1040) HBL – Investment ($ 5-7 M)
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Hadassah Bio-Park - 2008
First medical center “on-site” bio park – custom built for life science companies (including labs,Phase I center)
Building upon infrastructure of Hebrew U. Med. School and Hadassah University Hospital (conducting more than 50% of all translational medicine research in Israel)
HU conducts over 40% of all Biotechnology research in Israel.
Hadassah Ein-Kerem campus includes Med. and Dentistry schools, Nursing, Pharmacy & Public Health schools
First building to include 6 floors: total available space – 10,000 m2
Jerusalem municipality and JDA provide significant financial incentives: tax breaks and grants
5 HBL companies (+ HQ) to relocate
HBL
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Investment Strategy
High return on investment through investments before the first clinical phase (Phase I)
– After proof of concept in animals and before completion of Phase I
– Value multipliers: X 10 to X 50
– Midway Exit planned after Phase I, clear dividend policy
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Product target markets measured in the billions of dollars (“Blockbuster”)
– Oncology, tissue engineering, stem-cell medicine, auto-immune diseases
– Answer to Unmet Clinical Needs (not improvement of existing drugs)
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Risk Management– Dispersing risk through a portfolio of 9 companies in different fields
– Professional identification of investments and guidance of the companies by a team of technology and business experts
– Reducing company “burn-rate” by utilizing the infrastructure of Hadassah Hospital for development and clinical research
– Huge pool of future investment options (IP) – getting in at “ground level” with rapid increase in value
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10
1
At Phase I Increase in value of
10x to 30x
HBL’s “Sweet Spot” Highest rate of success
vis-à-vis required investment
Focus - Return on Investment
% required investment
Percent of total investment
Odds that company will advance from this phase to the next
Required investment $m Years
Approval
The Biggest Growth in Value Has Been atClinical Proof of Concept
Phase I/II Deals
$0
$100
$200
$300
$400
$500
$600
$700
2001 2002 2003 2004 2005 2006
$ M
illio
ns
0
2
4
6
8
10
12
14
16
18
20
No
. of T
ransa
ction
s
$ Upfront Total
No. of Deals
SOURCE: Windhover’s Strategic Transactions Database, June 2007
Upfront only (No milestones or royalties) – Ave. of 35 M
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Market Size Field/TreatingCompany
Stroke – US$ 500 mm;
Cardiac Arrest – US$ 1 billion
Thrombosis, Myocardial Infarction
Thrombotech
Systemic infections – US$ 6 billionDrug Reformulation – Systemic infections
ConjuGate
Cancer + Autoimmune diseases – US$ 5 billion;Cancer, Inflammatory DiseasesKAHR Medical
RA – US$ 5 billion;
Diabetes – US$ 3 billion
Inflammatory and Autoimmune Disease
Protab
Diagnostics – US$ 1 billion;
Treatment related drugs – US$ 6 billion
Cancer Monitoring and CureTK-Signal
Parkinson – US$ 1 billion
MS - US$ 1 billion
Cell Therapy – Parkinson Disease and MS
Cell Cure NeuroSciences
Diagnostics – US$ 500 mm;
Treatment related drugs – US$ 2 billion
Cancer Diagnostics and cure processes
Incure
US $300 mm; Autoimmune disease – US$ 20 billion
Graft Vs. Host DiseaseTolarex
US$ 2 billionLupus TherapyVerto
2 Market Size Market size in
billions
Unmet clinical needs
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Management
Dr. Rafi Hofstein - Chairman of the Board. President and CEO of Hadasit Ltd., the Technology Holdings Company of Hadassah Medical Organization. Ex-President of Mindsense Biosystems Ltd. Business Unit Director of Ecogen Inc., Langhorne PA after serving as the Scientific Director of its Israel office. Ph.D. and M.Sc. in life-sciences and chemistry from the Weizmann Institute of Science, B.Sc. in chemistry and physics from the Hebrew University in Jerusalem. Dr. Hofstein completed postdoctoral training at the Harvard Medical School in Boston, MA, in the departments of biological chemistry and neurobiology. Founder of ILSI, advisor to Israeli Govt., BoDs: Breath ID, Evogene, Bioline, ConjuGate, KAHR, ProtAb, Tolarex.
Adv. Ophir Shahaf - CEO. Appointed March 2007 after serving as VP of the Company since Jan. 2006. Ex-VP business development at Protalix Biotherapeutics Ltd. Part of the founding and management team of Clal Biotechnology Industries Ltd. as VP and general counsel. LL.B. from Tel Aviv University, MBA from the Stern School of Business at New York University. Teaches biotechnology entrepreneurship and management, fellow of the Merage Foundation at Irvine, CA. BoDs: Tolarex, ProtAb, Biokine, Thrombotech, ConjuGate.
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Board of Directors / Advisory Board
Prof. Shlomo Mor-Yosef, HMO Director General Yuval Cohen, Fortissimo Private Equity Doron Debbie (Consensus Business Group) Tsipi Gal-Yam (External) Yaron Kulas (External) Prof. Ruth Arnon (Weizmann) Steven G. Burrill – Burrill & Co. Tamar Howson (Bristol Myers Squibb, LexPharma) Mary Tanner (Biogen, NY Hedge Funds) Jonathan Silverstein (Orbimed VC) Jonathan Fleming (Oxford Biopartners VC) Cheryl Reicin (Torys LLP)
All department heads and leading physicians of HMO
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2 Major Strategic Investors / Partners have Invested in HBL Portfolio Companies, :
TEVA Pharmaceutical Industries - $ 1 M in Cell Cure NeuroSciences (Aug. 2007)– Recognition of leadership in HESC field– Attractive terms for company (value, rights)– Significant role in R&D, production and regulation
Clal Biotechnology (CBI) – Option Exercise + additional in Thrombotech (Sept. 2007)– $ 750 K exercise fee + $ 500 K in follow on round– Major shareholder participation (Total $ 1.75 M)– Sufficient to complete Phase I trials (Stroke / MI)– Experienced CEO and Chairman recruited
External Investments in Companies
IncurePR Marker
Early Stage Cancer detect
ConjuGateAmpho. B
Systemic Infections
BiolineRxBL1040BL2030
Acute MIProstate C
Thromb.TBT218Myocardial. Infar. Stroke
KAHRTSCP'sAuto Immune Disease
CellCureNeural Progen.
Multiple Scel. Parkinson
ForticellOrCell / FMB's
Hard-to-heal Wounds
ProtAbAP6Reum. Arth. Inf. B. Disease
TK SignalFenolDopam
MultipleMyeloma
TolarexApoCellGraft Vs. Host Disease
VertoLuposorbLupusDone
CompanyProductIndicationDiscoveryLead Selection
Efficacy in Animal Models
IND Prep.
Phase I
Phase I / II
Pha. II
Phase III
PMA
HBL Product Pipeline (7/08)
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Progress in Portfolio Companies (I)
Cell Cure NeuroSciences • Investment agreement with TEVA ($ 1 M at $ 13 pre-$)• HBL holdings increased to 34.5%• All IP related to Neurological Disorders (Parkinson, MS,
Alzheimer’s) – permanently released and owned by the company• Receipt of $ 2 M in "soft funding" – Michael J. Fox, ALS,
Beresheet, OCS• New VP of R&D, 4 additional researchers (>20 employees overall)
Verto• Completion of Phase I/II trial – 10 patients w. no side effects,
measurable therapeutic benefits. Trial complete – analysis and preparation of final report - ongoing.
• Discussions with potential strategic partners awaiting additional clinical data
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Progress in Portfolio Companies (II)
ProtAb (PTK)• Humanization and production of the lead antibody underway
(Antitope – Cambridge, UK). First samples arrived and tested.• OCS approved 60% of R&D budget ($ 500 K).• Discussions with private and VC investors.• Significant interest from strategic partners.
Thrombotech• Closed investment following option agreement with CBI ($ 1.75
M), including 300 K from HBL.• Recruited experienced CEO and Chairman.• Full set of pre-clinical and toxicology trials – repeated in "external"
lab with excellent results
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Progress in Portfolio Companies (III)
Tolarex (PTK)• Advanced preparations for clinical trial – Q1/08, Passed IRB,
awaiting MOH approval and pre-IND at the FDA• Additions of personnel (7) and equipment. OCS approved R&D
budget of $ 1.1 M (60% support)• CEO – experience in drug development (Alon Moran – BioMass)
KAHR Medical (PTK)• Negotiations with U. Penn for significant expansion of IP basis (5
new Compounds, based on TSCP’s - immune-related proteins)• Additional investment by HBL, Application for OCS support• Manufacturing contracts signed with Cobra and Invitrogen• CEO – Ex-VP of Compugen (Dr. Noam Shani)
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Progress in Portfolio Companies (IV)
Incure • Expansion of ELISA study – 40 patients. Groups added: elders,
smokers, pregnant.• Data showing detection of cancer metastases via blood sample.• Negotiation with US strategic partner – licensing & financing
deal.• Next step – commercialization via design of diagnostic kitConjuGate Ltd.• Platform targeted at unmet need – highly toxic drugs with
adverse side effects• Products to improve efficacy while eliminating toxicity, close to
phase I with lead product• Leading scientists, strong IP, 3 batches already produced. • Significant equity (33%), BOD representation (2 of 5) and
leading position in BD effort.
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Financial Data
$ 3.0 in cash, as of 1/6/08 3 Leading companies (PTK) raising between $ 3-5 M each All companies show major progress since HBL Investment Timeline: 3 companies in Phase I within 12-18 months Pipeline Potential: exclusive mandate (“first look”) for IP
from 1,200 MD’s/PhD’s at Hadassah, 250 patents yearly Top-notch science, IP protection, management HMO infrastructure allows for efficient financing, low BR
Current PIPE $ 5-7 M at par + warrants. Commitment from Hadassah,
CBG and other key shareholders to participate.
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Summary
All companies are funded by HBL, partners Leverage of “soft funds”: OCS, research foundations Science, IP and Infrastructure – HMO Key milestone events expected (Phase I, analyst
coverage and external investment) Validation of strategic model via external strategic
investors (CBG, Teva, CBI) Clear Exit strategy at end of Phase I NAV = 65% discount. Target of 7.5 NIS. Share price allows major appreciation linked to
milestones
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Thank You
Ophir Shahaf, CEO Hadasit Bio-Holdings Ltd. Tel.: +972-54-520-1177