2. 2
Disclaimer and Forward Looking Statements
This presentation does not constitute an offer or solicitation to participate in the
financing described herein. An offer to participate in the financing in certain jurisdictions
may be restricted. The Company expects to make an offer of participation in the
financing only to persons to whom such offer would not constitute a violation of any
law. In the United States an offer will only be made to those who fall within the
definition of "Accredited Investors" contained in Rule 501 of Regulation D promulgated
under the U.S. Securities Act of 1933, as amended.
Statements in this presentation that are not historical facts are forward-looking
statements based on current expectations of future events and are subject to risks and
uncertainties that could cause actual results to differ materially from those expressed or
implied by such statements. All of these forward-looking statements are subject to risks
and uncertainties that may change at any time, and, therefore, actual results may differ
materially from those expected.
All forward-looking statements included in this presentation are made only as of the
date of this presentation. We assume no obligation to update any written or oral
forward-looking statements made by us or on our behalf as a result of new information,
future events or other factors
3. 3
• An Israeli pharmaceutical company – acquires and develops patent protected drugs
in late clinical stages.
• 6 products of which 4 drugs are in preparation for pivotal trials (Phase II/III), and 2
products in Phase II.
• A potential blockbuster Crohn’s drug – market potential of $ billions.
• New formulations and new uses of existing drugs. Reduced risks – significant market
potential.
• More than $100 million invested in the products’ R&D.
• Raised over $12 million; Approx. $8.8 million in cash with no debt at IPO; low
monthly burn rate.
• Among existing investors; Rosalind Capital, (Toronto), Fidelity Venture Capital (Tel
Aviv), Dr. Shmuel Cabilly (inventor of Genentech’s “Cabilly Patents”) and additional
pharma investors from the US, Canada, Europe and Israel.
• Management team (Israel, USA, Canada, Belgium), with significant experience in
successfully developing patent-protected drugs.
• IPO on the Tel-Aviv-Stock-Exchange (TASE) to raise approx. $10 million for clinical
trials and commercialization.
Key Highlights
4. 4
Drug Indication Delivery
Pre
Clinical
Phase
|/||
Phase
||/|||
Planed
FDA
filing*
RHB-101 Cardio Oral Pill 2012
RHB-102 Oncology Oral Pill 2012
RHB- 103 Migraine Thin Film 2011
RHB-104 Crohn’s Oral Pill ** 2012
RHB-105 H. pylori Oral Pill 2013
RHB-106
Gastro
Prep.
Oral Pill 2012
RHB-107 Oncology I.V.
Planned next
step
Completed
Under
negotiation***
*Subject to changes
**Phase II/III combined
*** Under negotiation with an international pharma company – no assurance that negotiations will be completed
Product Pipeline
5. 5
Pre-Clinical
Tests
Phase II/III FDA Approval
and Partnering
Seller RedHill
New formulations and new uses of existing drugs
Patent-protected drugs
Generally cheaper, faster development, safer than new molecules,
close to market
Considerably higher chances of success
Business Model
Phase I/II
6. 6
Patent-protected
innovative drugs
New Molecules
Pfizer, Merck
New formulations and
new uses of
existing drugs
RedHill
Generics
Teva, Perigo
Low Profitability High Profitability
High Cost
High Risk
Low Cost
Low Risk
Why new formulations of existing drugs?
7. 7
New formulations
and new uses of existing drugs
Diversified underlying technologies;
Decreased risk of failure
Worldwide
patent protection
Significant target markets,
USD tens of millions S-
billions
Advanced clinical
development stage; Relatively
short time to market
To the extent possible,
relatively fast and low cost
regulatory path with significant
potential for success
Clear medical needs
Background Planning Implementation
• Many biotech companies
under-funded and willing to
sell excellent assets .
• In depth acquaintance with
the pharmaceutical market –
screening of approx. 150
acquisition opportunities.
• Clear acquisition criteria,
swift negotiations.
• Due diligence by leading
experts.
• Negotiating toward
acquisition of approx. 15
product opportunities and
acquisition of 6 drugs.
• Back-Loaded-Deals :
relatively small upfront and
success-based future
payments.
Criteria
Background, Planning, Implementation
8. 8
Company Ticker
Number of drugs close to, in
or beyond Pivotal Trials
(Phase II/III) for FDA approval
Market Cap.
(Dec. 1, 2010)
RedHill Private 4
Intec Pharma INTP 1 49$ million
BioLineRX BLRX 1 99$ million
D-Pharm DPRM 1 78$ million
CanFite
CFBI 2 45$ million
Prolor PBTH - 372$ million
Aposense APOS - 121$ million
Clal Biotech* CBI 5 483$ million
*A holding company, partial holding in portfolio companies
Comparables / Tel-Aviv Stock Exchange (TASE)
10. 10
Company/(Year) Product Phase Upfront $ Milestones $ Royalties $
Naktar – Bayer
(2007)
Inhaled Amicacin
(antibiotic)
2 50$ million Up to 125$ million
US: “shared
OUS: “Double Digit”
XenoPort – Glaxo
(2007)
Better-absorbed
Gabapentin
(restless leg
syndrome/pain)
3 65$ million 470$ million Double Digit
BioDelivery – Meda
(2007)
Oral film Fentanyl
(cancer pain)
3 30$ million 30$ million
“Significant Double
Digit”
Transcept – Purdue
(2009)
Sublingual
Zolpidem
(Insomnia)
3( post-NDA**) 25$ million 120$ million “Mid Twenty”
Protalix – Pfizer
(2009)
plant-cell
expressed
taliglucerase
(Gaucher’s)
3 (Pre NDA) 60$ million 55$ million 40%
Neuromed –
Covedien (2009)
Once-daily
hydromorphone
(pain)
3 (Pre NDA) 10$ million 40$ million Classified
Kamada – Baxter
(2010)
Glassia for
treatment of
Alpha-1 Antitrypsin
Deficiency
Approved 20$ million 25$
“Significant
Royalties”
* Random examples - no representation as to RedHill’s future business transactions
**NDA – New Drug Application (Application to receive marketing approval)
New Formulation License Deals / Examples*
11. 11
Prozac
Dramatic adverse effect on sales due to loss of patent
(depression and various other disorders)
• 1987: launched by Eli Lilly
• 2000: $2.6 billion sales of Prozac
• 2001: lost of patent and generic competition enter the market
• 2003: $240 million sales of Prozac
Ritalin
Dramatic commercial success thanks to a new formulation
(attention-deficit hyperactivity disorder (“ADHD”))
• 1995: Novartis launch twice-daily Ritalin
• 1996: Patent expired – leads generic competition into the market
• 2000: Alza launched “Concerta” (once daily Ritalin)
• 2001: J&J acquires Alza for $10.5 billion
• Q1/2010: “Concerta” quarterly sales reach $329 million
The Commercial Effect / Examples*
New
formulation
=
$329 million
quarterly
90% decrease
in sales
upon entrance of
generics
into the market
* Random examples - no representation as to RedHill’s future prospects
12. 12
Pharmacokinetic comparison of a leading
Triptan:
Thin Film V. Capsule
The Worldwide Triptan market for treatment of
migraine exceeds $2 billion
Ease of use – no need to swallow or consume water in
comparison with competing encapsulated drugs
Patent-protected oral thin film formulation of a leading Triptan
Migraine – a common neurologic episode.Indication
Drug
Potential
Advantages
Market
The Most Advanced / RHB – 103 (Migraine)
13. 13
Approximately 500,000 Crohn’s patients in the US alone (of which 200k-
250k are infected with MAP bacteria)
RHB – 104 market is approximately $2 billion in the US alone
Currently, there is no long -term effective solution
MAP* infection in Crohn’s
Patent protected, encapsulated antibiotic combination therapy
A Potential Blockbuster / RHB – 104 (Crohn’s)
Indication
Drug
Potential
Advantages
Market
* Mycobacterium Avium Paratuberculosis
A severe inflammatory disease in the GI tractThe Disease
Current drugs on the market only treat symptoms and are ineffective in
the long term
Competition
14. 14
"The results of the Australian Phase III clinical trial indicate a
tremendous therapeutic potential"
Dr. Tom Lang PhD )RedHill’s VP Clinical Affairs and Regulation)
Dr. Lang has over 30 years of experience in senior executive positions
in the pharmaceutical industry; Serono, Inc. (President and Vice Chairman), Warner
Lambert and others.
Mark A. Gilger, M.D.
Section Head, Gastroenterology, Hepatology & Nutrition Baylor College of Medicine Chief of
Service, Gastroenterology, Hepatology & Nutrition Texas Children's Hospital.
“RedHill's RHB-104 has the potential to become the leading therapy for
adult and children Crohn's patients infected with MAP”
RedHill’s Crohn’s drug / Unmet Need
“RedHill Crohn’s drug represents a real breakthrough in the treatment of
a disease which to date has no long-term effective remedy"
Dr. Shmuel Cabilli PhD (Director, RedHill)
Dr. Cabilli developed technologies underlying some of the currently leading symptomatic
treatments of Crohn’s .
15. 15
11 years of treatment with the drugs
acquired by RedHill
(The Australian Financial Review 2007)
“I was desperate”… “Sometimes the
cramps would make me fall into the
ground and cry in pain”
“He is symptom free and says he
doesn’t give his bowel a second
thought.”
The Crohn’s Drug / On the Map
16. 16
Leadership
*Management Team
Dror Ben-Asher, CEO
P.C.M.I. Ltd., Harvard ,Oxford
Ori Shilo, Vice CEO, VP Finance & Operations
P.C.M.I. Ltd., Director MobileMax
Gilead Raday, VP Product Development & Strategy
MSc Neurology, MBE Cambridge, Sepal Pharma
Adi Frish, VP Business Dev. and Licensing
Essex Un., Y. Ben-Dror, MediGus
Reza Fathi PhD, Senior VP R&D
XTL ,PharmaGenics ,Harvard Inst. of Chem. & Cell Biology.
Tom Lang PhD, VP Clinical & Regulatory Affairs
Serono US, Ciba-Geigy, Janssen, Warner-Lambert
Patrick Mclean, Product Manager
Axcan Pharma, Giaconda
Elkan Gamzu PhD, Product Manager
Cambridge Neurosciences, XTL, Warner Lambert, Roche
Pascal Weerts, Director of Corporate & Legal Affairs
Allen & Overy, Skadden Arps
Ira Kalfus MD, VP Medical Affairs
Pharmaceuticals, Aetna/US Healthcare
*Board of Directors
**Dan Suesskind
Teva, VP Finance, Director
Eric Swenden
Alterphama nv, Lifeline Scientific
Kenneth Reed MD
Dermatologist; Director Minerva Biotechnologies
Shmuel Cabilly PhD, Director
Scientist, Director in various life-science companies.
Dror Ben-Asher, CEO (see management)
Ori Shilo, Vice CEO, VP Finance & Operations (see
management)
* Specified background under each name relates to former and current positions
** To join officially following IPO
17. 17
Jeff Leighton, PhD (Chairman, Advisory Board)
Glaxo, Exogen, Genesis, Inspire, etc.
Prof. Colin Blakemore PhD (Scientific)
Oxford ; Past CEO, Medical Research Council, BTG
Ronald Goldenson MD (Medical)
South Shore Hospital, Boston
Werner Tschollar MD (Clinical and Regulatory)
Past Senior VP for Worldwide R&D at Novartis
Prof. Ran Oren, MD (Medical)
Hadassah (Jerusalem) – Digestive and Liver expert; Lecturer Tel –Aviv University
Prof. Thomas Borody MD (Medical)
Founder, Centre for Digestive Diseases (Sydney); Former Clinical Fellow, Gastroenterology, Mayo Clinic
Joshua Schein PhD (Strategic)
Past CEO and Co-founder Lev Pharma, Founder Depomed Inc. and Callisto Pharma
Mr. Abe Shwartz (Strategic)
Covalon Tech., CEO Cedara Software, Director Merge Healthcare Inc.
Mr. Yossi Hod (Corporate Strategy)
Strategic advisor, executive experience in technology companies
Jerry Rosenblatt PhD (Marketing)
IIBD Consulting, IMS Health, Professor of marketing Concordia University
* Specified background under each name relates to former and current positions
Advisory Team*
18. 18
VP Medical Affairs
Ira Kalfus MD
VP Clinical &
Regulatory Affairs
Tom Lang PhD
RHB-104/5/6
Product Manager
Patrick McLean
RHB – 101/102
Product Manager
Gilead Raday
VP Product Development
& Strategy
Gilead Raday
VP Business Dev
& Licensing
Adi Frish
Director of Corporate
/Legal Affairs
Pascal Weerts
Vice CEO
VP Finance & Operation
Ori Shilo
Senior VP R&D
Reza Pathi PhD
CEO
Dror Ben-Asher
Board of Directors
Chairman Advisory Board
Jeff Leighton PhD
Organizational Chart
Confidential
RHB-103
Product Manager
Elkan Gamzu PhD
19. 19
Approx. $12 millionCapital raised prior to IPO
Fedility VC biotechnology fund, the Canadian
biotech fund Rosalind Capital, Lautman family, Dr.
Fischer Group, Dr. Shmuel Cabilly, and other
pharma investors from N. America, Europe, Israel
Investors – a partial list
Approx. $8.8 millionCash (as of January 1st, 2011)
Approx. $10 millionPlanned IPO raise
Primarily for R&D (mainly RHB-104), regulatory
costs, acquisition of new products, ongoing
business activities
Use of IPO proceeds
IPO Snapshot
20. 20
Experienced management,
international
Sound business model,
low risk, high potential
Strong balance sheet
and shareholders base
All drugs are patent-protected
Advanced clinical stages
Diverse drug pipeline addressing large markets
Clear medical needs
Summary
21. RedHill Biopharma Ltd.
42 Givati St. Ramat-Gan
Israel 52322
E:mail: info@rdhillbio.com
Web: www.redhillbio.com
Tel: 972-3-676-1706
Thank You!
23. 23
RHB – 101 (Cardio)
Indication Congestive heart failure (CHF), hypertension (high blood pressure )
Drug A controlled release formulation of Carvedilol (GSK’s brand name “Coreg”)
Potential Advantages Allows once-daily oral consumption, Price
Market Size
Worldwide target market of $500 million
Clinical Trial
Several clinical trials were conducted
Planned – pivotal trial (equivalent to Phase III)
Acquired from -
Egalet – a Danish private pharmaceutical company,
funded by venture capital funds
24. 24
RHB – 102 (Oncology – Nausea & Vomiting)
Indication Prevention of chemotherapy induced nausea and vomiting
Drug
Once-daily controlled release tablet formulation
of Ondansetron (GSK’s brand name “Zofran”)
Potential Advantages Allows once-daily oral consumption during chemotherapy treatment, Price
Market Size
Drug market for serotonin receptor inhibitors (similar drug family)
is estimated at $700 million in the US alone
Clinical Trial
Pilot clinical trial conducted
Planned – pivotal trial (equivalent to Phase III)
Acquired from -
SCOLR Pharma, Inc. , a US public corporation
NYSE, AMEX: DDD
25. 25
RHB – 103 (Migraine)
Indication Migraine – a common neurologic episode
Drug Oral thin film formulation of a leading Triptan
Potential Advantages
Ease of Use
No need to swallow or consume water in comparison
with competing encapsulated drugs
Market Size
The Worldwide Triptan market for the treatment of
migraine exceeds $2 billion
Clinical Trial
Pilot clinical trial conducted
Planned – pivotal trial (equivalent to Phase III)
Acquired from -
IntelGenx Corp., a Canadian public corporation
TSX V. IGX; OTC BB: IGXT
Co-development agreement in place
26. 26
RHB – 104 (Crohn’s)
Indication
Treatment of MAP (Mycobacterium Avium Paratuberculosis )
infected Crohn’s patients
Drug
Patent protected combination of three antibiotic ingredients
in a single capsule
Potential Advantages
Currently there is no drug on the market which treats MAP bacteria
infection in Crohn’s patients (40%-50% of Crohn’s patients)
Market Size Approx. $2 billion in the US alone
Clinical Trial
Several clinical trials were conducted, including a Phase III trial in Australia
Planned – Phase II/III clinical trial in MAP infected patients
IND status (FDA clearance to conduct the trial)
Acquired from -
Giaconda, an Australian public corporation,
ASX:GIA
27. 27
Note: Two studies for reference only; Remicade study results only reflect
responders vs. those who entered the trial
*A leading drug for symptomatic treatment of Crohn’s (marketed in the
US by Centocor and in Europe by Schering - Plough
16 weeks
66% remission
p = .017
52 weeks
42% remission
p = .006
104 weeks
33% remission
p = .010
30 weeks
39% remission
ITT = 23%
30 weeks
45% remission
ITT = 26%
112
5 mg; 10 mg / kg
113
5 mg / kg
110 Placebo
110 Placebo
54 weeks
N/A
54 weeks
N/A
54 weeks
N/A
30 weeks
21% remission
ITT = 12%
104 weeks
18% remission
52 weeks
25% remission
16 weeks
50% remission
213 111 Placebo
+prednisolone
Weaned (100%)
Accent I Study
573 patients 5 mg /
kg335 responses
(58%)
213 Patients
(100%)
Australian
Phase III
Accent I Study
573 patients
5 mg / kg
Crohn’s Patients
102 Active
+ prednisolone
weaned
RHB – 104 (Crohn’s) / Phase IIIa
Results in comparison with Remicade*
RHB-104
“Myoconda)
Remicade •Positive remission results
•At the time of the trial it was impossible to
identify MAP bacteria (today – its possible)
•Today, RedHill’s RHB – 104 is an improved
formulation
28. 28
RHB – 105 (H. pylori)
Indication
Treatment of infection in the GI tract resulting from resistant Helicobacter
pylori bacteria
Drug
Patent protected combination of three known
and approved substances
Potential Advantages Effectiveness in events of bacteria resistance
Market Size Worldwide market estimated at approx. $180 million
Clinical Trial Phase IIa conducted
Acquired from -
Giaconda, an Australian public corporation,
ASX:GIA
29. 29
RHB – 106 (Gastrointestinal Preparation)
Indication
Preparation of the GI tract for
GI procedures/surgeries (such as colonoscopy)
Drug Patent protected encapsulated formulation for bowel preparation
Potential Advantages No need to consume solution; lack of bad taste
Market Size Approx. $490 in the US alone
Clinical Trial Phase IIa conducted
Acquired from -
Giaconda, an Australian public corporation,
ASX:GIA
