DC276 Genpharm July2014
User Manual: DC276
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GENPHARM OVERVIEW
July 2014
Confidential 2
Business Overview
Creating specialty pharmaceuticals leadership in MENA …
Overview
Algeria Libya Egypt Saudi
Arabia
Yemen
Oman
Morocco Iran
Women’s
Health
Immunology
Infectious Disease Neurology Rare Disease
Specialty Therapeutic Focus
Genpharm is a specialty pharmaceutical
marketing and consulting company
focused on niche therapeutics and
diagnostics for rare disease
It provides fast and sustainable market
access into the MENA (Middle East &
North Africa) region to its strategic
partners including regulatory and
medical
It provides Business Development and
market analysis for companies looking to
evaluate the potential of their portfolio in
MENA.
It acts as the representative agent for
rare disease, biotech and specialty
pharma companies looking to enter or to
expand in the MENA
Algeria Libya Egypt Saudi
Arabia
Morocco Iran
Tunisia Syria
Lebanon
Jordan
Iraq
Yemen
UAE
(Dubai, Headquarter)
Kuwait
Bahrain
Qatar
MENA
Geographical Presence
Confidential 3
Company Overview
Mission, Vision & Values
To provide healthcare
organizations with innovative
therapeutic solutions in niche
and rare genetic disease areas,
market access strategies and
sustainable commercial
solutions,
while improving patient care
and quality of life in the Middle
East and North Africa.
“We strive to be the partner of
choice for multinational
healthcare
and pharmaceutical companies
expanding into the Middle East
and North Africa region.
We aim to consistently
differentiate ourselves by
serving all of our stakeholders
through evidence based
medicine.”
Our Vision Mission Statement
Patient Care
We are
dedicated to
patient care and
quality of life
Integrity
We act honestly,
with inclusivity
and respect
Innovation
We offer unique
and sustainable
solutions
Accountability
We are
committed,
reliable and
results focused
Teamwork
We are positive,
professional and
transparent
Iran
Core Values
Confidential 4
59% 42% 32% 34% 38% 40%
34%
49% 55% 56% 52% 48%
6% 8% 10% 8% 8% 10%
1% 1% 3% 1% 2% 2%
0%
20%
40%
60%
80%
100%
UAE KSA Egypt Jordan Morocco Tunisia
Segment Value by Country
Original Brands Branded Generics Others Unbranded Generics
Targeted and Focused Positioning for
Genpharm
Genpharm is purposely positioned in the original brands market…
Unbranded
Generics Branded
Generics Unprotected
Originals Protected
widely RX Niche
Specialty
Commodity Differentiated
High Volume & Low
Margin
Tight Control of Cost
Focus on Supply Chain
Purchasing professionals
are the key stakeholders
Promote price and
service
Seek scale to gain cost
efficiencies and market
power
Lower Volume & High
Margin
Emphasis on Quality
Focus across a complex
set of stakeholders
Promote efficacy, safety,
tolerability
Seek differentiation to
drive demand
Business Model Characteristics for different product types
30% 27% 22% 18% 27% 18%
57% 61% 60% 61% 54%
52%
12% 12% 16% 18% 17% 29%
2% 1% 2% 3% 2% 2%
0%
20%
40%
60%
80%
100%
UAE KSA Egypt Jordan Morocco Tunisia
Segment Volume by Country
Original Brands Branded Generics Others Unbranded Generics
Source: IMS MIDAS June 2012, Licensing Data, Rx bound
Note: RX = Protected Formula/Product
31%
Genpharm operates across the entire MENA region and in 8 countries out of
the top 10 MEA countries
Confidential 5
Supportive MENA Pharmaceutical Market
2012 (Genpharm MEA Countries)
2017 (Genpharm MEA Countries)
2012 (Non-Genpharm MEA Countries)
2017 (Non-Genpharm MEA Countries)
3.4
2.5
2.3 2.2
1.9
0.6
1.0 1.0 0.9
1.2
5.1
4.8
3.4
3.1
2.4 2.3
1.9
1.5
1.1 1.0
0.0
1.0
2.0
3.0
4.0
5.0
6.0
KSA Egypt South
Africa Algeria Iran Libya Nigeria UAE Morocco Syria
MEA Pharmaceuticals Sales (€bn)
(Top 10 by 2017 sales)
9%
14%
8%
7%
5%
13%
10%
5% -5%
Source: IMS Health Market Prognosis May 2013. Values ex-mfn. at constant exchange rate. Revised Forecast due Sept 30 2013.
Confidential 6
Overview of current Products & Services
Sustainable market access solutions that provide long-term value
Consultancy Specialty Pharma
Identify business potential
Recommend appropriate business & operations
models
Recommend strategy & organization
Formulate adapted market access strategies
Registration
Marketing, Promotion & sales force effectiveness
Fast track market penetration through NPS
Importation & distribution & Tender participation
Medical & PV services
Current Partners and Products
Genpharm Services
Aubagio ChondroCele
ct
Juxtapid Stalor
al NIOX NIPT
PrenaTest
Global Pharmaceutical Manufacturers
Baclofe
nGene Therapy Bemfola
Company Overview
Signs agreement for
commercialization of
Bemfola
Confidential 7
In 24 months
Oct, 2012
Nov, 2012
Signs agreement for
commercialization of
ChondroCelect
Stallergenes SA and
Genpharm Services extend
collaboration to Egypt
Genpharm starts
operations
April, 2012
Signs commercialization
and distribution agreement
for PrenaTest
Dec, 2012
Feb, 2013
Signs commercializaton
agreement with Genzyme
for Aubagio in MS
Apr, 2013
Sponsors orphan drug
meeting in Washington
DC, US
Apr, 2013
Multiple-year agreement
with Aegerion
Pharmaceutical
Jun, 2013
Holds ASPIRE
event for MENA
Neurologists
Oct, 2013
Sponsors orphan
drug meeting
Geneva
Nov, 2013
Signs
commercialization
deal for Baclofen
Signs promotional
agreement for Stallergenes’
AIT treatments in the UAE
Gene Therapy
Market Assessment
Apr, 2014
Jan, 2014 Sponsors Orphan
Drug Congress,
Washington
Apr, 2014
Jun, 2014
Company Milestones
Confidential 8
Aubagio is an FDA & EMA approved once-daily oral tablet, developed by Genzyme, A Sanofi Company, that offers an effective
alternative for patients suffering from Relapsing Multiple Sclerosis (RMS)
Genzyme has partnered with Genpharm to commercialize Aubagio in the MENA region
Juxtapid is an oral inhibitor of the microsomal triglyceride transfer protein (MTP) and is specifically indicated as an adjunct to a low-
fat diet and other lipid-lowering treatments
Aegerion Pharmaceuticals partnered with Genpharm to commercialize Juxtapid (Lomitapide) in the Levant region
Staloral is a sublingual product for patients suffering from moderate to severe allergic rhinitis and/or mild to moderate allergic asthma
Stallergenes has partnered with Genpharm to commercialize Staloral in U.A.E and Egypt
NIOX, developed and distributed by Aerocrine/Stallergenes, is the first point-of-care medical device for measuring Fractional Exhaled
Nitric Oxide (FeNO)
Stallergenes partnered with Genpharm to commercialize NIOX in the U.A.E
ChondroCelect is the only approved somatic cell therapy product from TiGenix, Belgium for repair of cartilage lesions in the knee
using characterized viable autologous cartilage cells
TiGenix NV partnered with Genpharm for commercialization of ChondroCelect in the GCC and Levant region
PrenaTest is the first Non Invasive Prenatal Diagnostic (NIPD) developed by LifeCodexx in Germany for the detection of Down’s
syndrome, Edwards Syndrome and Patau Syndrome
LifeCodexx AG partnered with BioGen Medical and Genpharm for the commercialization and distribution of PrenaTest in Turkey, the
Middle East and Gulf regions
Baclofen® Sintetica Intrathecal is indicated severe chronic spasticity originating from Multiple Scelerosis, Trauma or other spinal
cord disorders unresponsive to other orally administered antispastic agents and/or for patients that experience serious adverse
events from orally administered doses.
Baclofen
Bemfola® is the first Swiss biosimilar recombinant FSH, approved by the EMA for the treatment of couples suffering from Infertility
Portfolio overview
Confidential 9
Experienced Management Team
14 years of regional experience in
Senior Executive roles in the Pharma
industry
Launched and managed operations for
several Biotech and rare disease products
including (go to market strategies &
funding)
Wide expertise and network in emerging
markets, in particular in the Middle East &
North Africa Region as well as in South
East Europe and Russia.
Active member of several industry
associations and business councils
Member of the Diplomatic Circle in Geneva
and Public speaker on industry matters
Mr. Karim Smaira
Co-founder & CEO
More than 25 years of regional Pharma
experience in Senior Executive roles
within MNCs & Distributors.
Established and Managed several regional
offices in MENA
Pharmaceutical entrepreneur with several
start ups in the region, active member of
several industry associations and business
councils
Honored by Rotary several times as Paul
Harris Fellow for meeting outstanding
personal, professional standards and
charitable work.
Several awards recognizing successful
businesses in MENA
Mr. Kamel Ghammachi
Co-founder & Managing Partner
Confidential 10
CEO NextPharma
Former Deputy CEO
Merck-Serono, Executive
Vice President
International and
emerging markets Merck-
Serono
Former Head of product
development at
SERONO
CEO of Emirates NBD;
the largest regional
bank by Assets
Board Director Emirates
Islamic Bank
Head of Corporate
Banking HSBC Middle
East; President and CEO
of HSBC Korea
Director in Emirates Fund
Managers (Jersey)
Limited, and a founder
member of Visa CEMEA
Advisory Forum
Chairman of the
Cigalah group, a leading
pharmaceutical company
and distributor in KSA &
part of the Naghi holding
Founding member of the
Swiss Arab Postgraduate
Clinical Acedemy
(SAPCA in 2010)
Board Member of several
industrial and business
groups in KSA
Founding Partner &
Managing Director of
Genyx LLC
consultancy,
specializing in
management consulting,
staff engagement and
alignment, employee
assessment, senior
executive coaching in
several industries
including Pharma.
Former Vice President of
Pearson Higher
Education, UK
Former Vice President of
Nelsom Education,
Canada
Mr. Franck
Latrille
Mr. Rick
Pudner
Sheikh Yasser
Naghi
Mr. Dave
Dimmell
Senior Non-Executive Board
11
Holistic Market Approach
Purchasers
Scientific
Societies
Physicians
Government
Programs
Distributors
Health Insurance
Hospital
Pharmacies
Patient
Associations
Confidential 12
Delivering new drugs to MENA markets
Genpharm masters product registration and commercialization across MENA
Algeria
Jordan
KSA
Yemen Lebanon Bahrein
Kuwait
Iran Egypt
Morocco Iraq UAE
Qatar
Tunisia Libya
Social Sec.
Some Gvt.
Private
Slow Reg. ~3 years Avg. ~15-18months Rapid Reg ~12month
Registration: Background and Insights
Pre-registration sales for early returns
Registration friendly environment in GCC
Possibility for centralized registration procedure & fast track
Pricing Harmonization & International referencing system
Government coverage for nationals and privatization trend
Commercial and supply chain: Channels and networks
Direct management of a network of distributors chosen
over more than 40 years of experience
Logistics and distribution managed through well
established sub-distributors with solid financials
Direct relationship with purhcasing departments of major
hospitals across MENA
Scrip generation through KOL management and strong
network with major institutions
Active role in Pharma forums in the region.
Established reputation of Genpharm management in the
Pharma industry
13
2012 2013 2014 2015 2016 2017
Business Development
10+ Products
DX/Med Device
Unit
Revenue
Proprietary Branded
Products
Major Products Acquisition
2012-2013: The party
to talk to
2014-2016: The spec
pharma in progress
2016 and >: Emerging pharma
company leader
Long term ambitions : Growth and Sustainability
Which Path to Maximal Strategic Value ?
Western Europe
Size: €128-150 bn
CAGR (2013-17): -2% to 4%
Middle East
Size: €12-19 bn
CAGR (2013-17): 12% to 14%
Africa
Size: €19-26 bn
CAGR (2013-17): 7% to 10%
Central & Eastern Europe
Size: €48-56 bn
CAGR (2013-17): 4% to 7%
Asia Pacific
Size: €202-216 bn
CAGR (2013-17): 12% to 15%
North America
Size: €276-298 bn
CAGR (2013-17): 1% to 4%
Latin America
Size: €71-78 bn
CAGR (2013-17): 10% to 13%
Supportive MENA Pharmaceutical Market
Middle East is one of the fastest growing pharma markets
14
Low Growth
(< 4%)
High-Mid Growth
(7% to 13%)
High Growth
(12% to 15%) Low-Mid Growth
(4% to 7%)
Source: IMS Market Prognosis, Apr 2013
Note: Western Europe includes EU5 and rest of Western Europe; Size: 2013-2017, CAGR is between 2013-2017
Confidential
Confidential 15
7,572
28,633
30,611
37,805
1,097
4,439
8,305
10,457
5,892
2,275
3,567
4,610
5,270
7,539
17,223
17,931
18,540
32,007
35,653
76,595
Global
UK
Germany
US
India
China
Brazil
Russia
MENA
Egypt
Jordan
Iraq
Iran
Lebanon
Bahrain
KSA
Oman
UAE
Kuwait
Qatar
GDP per capita €, 2012
MENA population growth to outpace other economic groups
Strong MENA Macro Background
2.0%
0.8% 0.7%
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
MENA Countries Developing Countries Developed Countries
Top Countries
where
Genpharm
Operates
Developed
Economies
Developing
Economies
Population Growth (CAGR 2013-2018)
390
320 346
-
50
100
150
200
250
300
350
400
450
MENA Total Top 5 European
Countries North America
Population, 2012 (mn)
Source: IMF Data
Note: Developing Countries - China, India, Brazil & Russia; Developed Countries - US, Germany, UK & Canada; North America - US & Canada; KSA stands for Saudi Arabia; Top 5 European Countries –UK, Germany, France, Italy, Spain; MENA
Countries - Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Mauritania, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, UAE & Yemen; Conversion rate used across slides: 1 US$ = €0.73118
2
11
17
30
31
33
66
78
87
99
123
48
62
89
143
10
21
23
#Rank out of 188
countries
Confidential 16
Strong MENA Macro Background
7.2%
6.1%
5.0%
4.2% 4.2% 4.0% 3.8% 3.8% 3.7% 3.6% 3.5% 3.2% 2.8%
1.4%
4.1%
7.1%
5.8%
3.1% 3.1% 2.9%
1.9% 1.2%
3.8%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
8.0%
Iraq
Qatar
Morocco
KSA
Tunisia
Jordan
Oman
Bahrain
UAE
Algeria
Egypt
Lebanon
Kuwait
Iran
MENA
China
India
Russia
Brazil
US
UK
Germany
Global
Average GDP Growth (2013-2018)
Strong GDP growth provides an upside to healthcare spend
Health expenditure
per capita: €394
Health expenditure
% of GDP: 4.6%
Health expenditure
per capita: €103
Health expenditure
% of GDP: 3.9%
Health expenditure
per capita: €316
Health expenditure
% of GDP: 5.2%
Health expenditure
per capita: €6,294
Health expenditure
% of GDP: 17.9%
MENA1India China United States
Source: IMF, World Bank
Note: (1) MENA comprises Arab World and Iran; Health Expenditure - Data is for 2011, Healthcare expenditure per capita PPP (constant 2005 international $ converted to Euro)
Confidential 17
…and in the orphan drug market which is consistently outgrowing the
non orphan drug market
Targeted and Focused Positioning for
Genpharm
24.1
27.8
33.6
40.9 44.6
50.5
57.0
60.7
65.8
70.2
76.0
80.4
86.3
92.9
18%
15%
21% 22%
9%
13% 13%
6%
8%
7%
8%
6%
7% 8%
8% 8%
9%
7%
2% 1%
5%
-3%
0%
3%
4% 4% 4% 3%
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
90.0
100.0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Global Orphan Drug Sales (€bn)
Global Orphan Drugs Growth Global Non-Orphan Drugs Growth
Source: EvaluatePharma, April 2013
The rare disease drugs are highly priced
due to their research and development
cost. Customers are typically government
hospitals and similar institutions with a
substantial budget for their patients.
Confidential 18
[…]
Fast track
Registrations
Limited Number
Of Prescribers /
Physicians
Institutional
Customers
Named Patient
Sales
High Value
Products
Genpharm is well positioned in market segments that offer a number of
attractive commercial characteristics:
Genpharm operates in the niche,
rare disease/Orphan Drug markets
where the number of patients and
prescribing physicians is limited
Innovative products for unmet medical
needs are given fast approval and
reimbursement pathway
Robust local expertise & knowledge of
the local processes
Existing network with key decision
maker centers and stakeholders
markets further helps to access
regional markets and help companies
with fast track registrations
Genpharm manages all
stakeholders including Physicians,
Patient groups, Payers and
Distributors
Need of a highly competent,
evidence based selling and
promotion approach through a
limited number of KAMs/MSLs
For unmet medical needs and specialty therapeutic, products can be
purchased on a Name Patient Sales basis prior to registration.
Fast track market access and market penetration. Early sales upside
Targeted and Focused Positioning for
Genpharm
Confidential 19
GENPHARM
MENA’s fast growing economy
High GDP per capita levels
Rising income levels, increase in literacy levels,
higher healthcare spend by government
Strong MENA
Macro
Background
Middle East markets are expected to
grow from €12bn in 2012 to €19
bn in 2017, 12-14% growth is among
the highest in the world
Supportive MENA
Pharmaceutical
Market
Genpharm has strong and
high-profile board of non-
executive members that
bring along comprehensive
experience
Senior Non-Exec
Board
Genpharm has an experienced
management team and extensive
network with key stakeholders
Strong
Management
Team
Genpharm Summary
Genpharm operates in fast growing Orphan drug
market that is expected to reach €93 bn by
2018, while there are ~2.8 mn people in the
Middle East that are affected by rare disease
Targeted and
Focused
Positioning
For enquiries and contact:
Dubai Biotechnology & Research Park
P.O. Box 8145
Dubai, United Arab Emirates
Tel: +971 4 4227010
info@genpharmservices.com
www.genpharmservices.com
