GENPHARM OVERVIEW July 2014

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