BUILDING A TOP 10 GLOBAL GENERICS PLAYER
20 November 2014 1
CONTENT
OVERVIEW
Alvogen worldwide
Regional focus
Biopharmaceuticals
Highlights
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ALVOGEN TEAM HERE TODAY
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KEVIN BAIN – CHIEF FINANCIAL OFFICER
MING LI - VICE PRESIDENT, CORPORATE
FINANCE
GEORG INGRAM – EXECUTIVE VICE
PRESIDENT,
GLOBAL BUSINESS DEVELOPMENT
TONY AMATO – VICE PRESIDENT,
BUSINESS DEVELOPMENT (AMERICAS)
ALVOGEN AROUND
THE WORLD
international pharmaceuticals company, focused on developing, manufacturing and distributing generic, brand and over-the-counter products
domiciled in Luxemburg – commercial operations in 34 countries – 2300 employees
significant investment in development of five monoclonal antibodies going off patent after 2018 via sister company, Alvotech
regional hubs in North-America, Asia Pacific and Central Eastern Europe
led by a highly experienced management team with a proven track record of achieving high growth and profitability
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PROGRESS SINCE LAST
CONFERENCE
naprelan acquisition completed
Pamplona Capital Management joins Alvogen
Lotus pharmaceuticals acquisition in Taiwan
Dream pharmaceuticals transaction signed,
closing expected year end
expanded US pipeline of filed products, including
numerous P-IV challenges
over 350 submissions ex-US in CEE and APAC
continued growth of the underlying business;
2013 to 2014
launch of Infliximab in CEE markets; biosimilar to
Remicade™
ALVOGEN IN NUMBERS
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78%
5
200
5
60
2300
2009 to 2013 revenue CAGR, 59% organic
Employees
Manufacturing and R&D centers
Generic products in pipeline
Biosimilar products in pipeline (mab’s)
Pipeline ANDA‘s for the US market
Marketed products350 0
100
200
300
400
500
600
700
2009 2010 2011 2012 2013 2014
Reve
nu
e U
SD
mil
lio
ns
2013 and 2014 are presented pro forma
3 MAJOR REGIONAL
PLATFORMSUSANew Jersey
EUROPERomania
ASIATaiwan
S-Korea
CROBangalore
Albania Bulgaria Bosnia
China Croatia Estonia
Hong Kong Hungary
Iceland Ireland India
Kazakhstan Kosovo
Latvia Lithuania
Macedonia Malaysia
Moldova Montenegro
Myanmar Netherlands
Philippines Poland
Romania Russia Serbia
Singapore South Korea
Thailand Taiwan Ukraine
USA UK Vietnam
34 COUNTRIES
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USA 48% CEE 22% APAC 30%
BALANCED AND
SPECIALIZED PORTFOLIO
U.S. product portfolio built on Alvogen’s
focus on niche generics, transdermal
patches, controlled release, narcotics and
biopharmaceutical products
200+ pharmaceutical projects in
development and registration
global product portfolio consists of a broad
range of leading molecules for the
treatment of conditions in the fields of
oncology, cardiology, respiratory medicine,
neurology and gastroenterology
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TARGETED PRODUCT PIPELINE
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pipeline with a mix of complex high value
generic products
three biosimilars already on the market in
CEE and additional five in the pipeline
60 pipeline ANDA’s in the US
focus on first-to-file / first-to-market
opportunities
numerous niche products in development or
awaiting approval – including transdermal
patches, sublingual films and topicals
First Alvogen products launched in
CEE
First products launched in APAC
CEE packaging center built in
Serbia
International infrastructure built:
supply chain, quality, and
commercial
Built CRO in Bangalore, India to
manage clinical trials, biostudies,
and pharmacovigilance services
Biosimilar partnership signed, first
biosimilars sold in CEE
2013 HIGHLIGHTS
Norwich Pharmaceuticals
established in New York
1887
Jan 2010, new
corporate identity is
launched
Dec 2010, Alvogen
acquires Keri Pharma in
Hungary
Acquisitions of Labormed
(Romania), Kunwha (Korea) and
Lotus (Taiwan) provide CEE and
APAC with marketing and
manufacturing hubs in respective
regions
PRIOR TO 2001
Proctor and Gamble
invest heavily in
pharmaceuticals and build
plant in Norwich, NY
The plant subsequently
becomes a contract
manufacturer
In Sept. 2009, Robert
Wessman joins
Alvogen as Chairman
and CEO
New business model is
launched
First products sold in US
Internal R&D created
Global business
development formed
Global regulatory formed
First sales offices
established in CEE
2011 HIGHLIGHTS
Received DIANA award
for excellence from the
Health Distribution
Management Association
in the U.S.
Received CMO
Leadership Awards
Sales ramp in every
region of the world
Two strategic acquisitions
at year end
Alvogen acquires
Naprelan® in the US
Announces intention to
invest $250 million in
biotech manufacturing
and R&D
DIANA awards received
again as best generic for
notable achievement in
healthcare in the U.S.
Received CMO
Leadership Awards
again
2009 2010 2011 2012 20132001
2012 HIGHLIGHTS2012 HIGHLIGHTS
HISTORY OF DYNAMIC GROWTH
0
2014
2014 HIGHLIGHTS
0First-to-market with
Inflectra in Europe with
Hospira
67% stake acquired in
Lotus in Taiwan to
strengthen regional
platform
Second acquisition in
Korea under way
Company of the Year
in Americas and
Business Development
of the Year Awards by
Generics Bulletin at
CPhI in Paris
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EXPERIENCED LEADERSHIP TEAM
WITH PROVEN TRACK RECORDS
Robert WessmanChairman and CEO
William HillAmerica Commercial Operations
Petar VazharovCEE Commercial Operations
Renaat JanssenAsia Commercial Operations
Georg IngramBusiness Development
Lisa GraverAmerica Strategic Development
Kevin BainCFO
Arni HardarsonChief Legal Counsel
Svafa GronfeldtOrganizational Development
Chris YoungSupply Chain
Fjalar KristjanssonQuality Affairs
Thor KristjanssonMergers and Acquisitions
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SVAFA KEVIN RENAAT
GEORG
CHRIS
ARNI LISA FJALAR
THOR PETAR BILL
ROBERT
STRATEGIC ROADMAP
High value high margin
opportunities:
• 350 marketed products
• 200 pipeline products
• 2000 filings WW till
date
Focus on high value
• Transdermal
• Films
• Controlled substances
• Controlled released
• Biosimilar
• OTC
Higher growth potential
Alvogen strategy is
based on 3 market
segments:
• High growing Asian
markets
• Central and
Eastern Europe
• US retail with focus
on niche generics
5 manufacturing
plants in 3 regions:
USA, Europe and Asia
Total capacity of
8 billion tablets
The Alvogen US facility
is the largest with
capacity of 3,5b
Unsurpassed quality
history in US.
Strong team with
experience operating
sites and managing
quality around the globe
3 strong regional platforms
for manufacturing and
R&D – providing flexibility
Gaining competitive
advantage by new
innovative solutions to
industry challenges
Sister company
Alvotech building a
biosimilar pipeline and
state-of-the art facility
for five monoclonal
antibodies
Working with a strong
network of partners to
offer holistic solutions
and capabilities to
enhance scope, speed
and efficiency
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REGIONAL
FOCUS
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AMERICAS
generics and brand portfolios; commercial, operational
and product development infrastructure and CMO
services
portfolio of difficult to produce generics
one of the strongest pipelines of transdermal patches in
the U.S. market
IMS fastest growing generics company (2012), top
(10) generics company ranking, excellent commercial
reputation with deep customer relationships (DIANA and
CMO Leadership Awards two consecutive years)
robust business development engagement with
emphasis on proactive opportunity generation
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AWARD WINNING TEAM
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In a short amount of time, Alvogen has become a well
recognized supplier in the U.S. generics market.
HDMA Diana Award
2014 Winner
2013 Winner
2012 Honorable Mention
2014 McKesson Trade Partner of the Year award
2014 Cardinal Health – Supply Chain Excellence award
winner
2013 McKesson Emerging Company honorable mention
2014 The CMO Leadership Awards (Norwich site)
2013 The CMO Leadership Awards (Norwich site)
ASIA PACIFIC
established APAC platform for future growth –
public listings in Taiwan and Korea
generic sales and marketing (Gx), product
development, manufacturing and a growing portfolio
of OTC products and clinical research (CRO)
focus on branded generic markets that value quality
leverage on the well established business of Kunwha
and Dream Pharma in South Korea and Lotus in
Taiwan
growth driven by growing product pipeline and
further geographical expansion
significant investments have been made in high
quality standards and training
utilizing the consolidation opportunity in the region
can enable Alvogen to become the 1st major pan-
regional leader
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CENTRAL &
EASTERN EUROPE
best in class sales and marketing infrastructure
generic products marketed and sold via Hospital and
retail channels
robust portfolio of biosimilars consists of leading
molecules for the treatment of oncology, rheumatoid
arthritis and anemia
growing OTC portfolio
strong high quality EU approved manufacturing platform
in Romania, serving the entire CEE region
centralized supply chain and product launch
coordination
exceptional regulatory team with a solid track record
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BIOPHARMACEUTICALS
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BIOPHARMACEUTICALS
ARE THE FUTURE
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biologic molecules are the future of the
pharmaceutical industry due to type of diseases it
treats and precision of targets.
8 of top 10 products worldwide are biologics.
around 50% of new industry launches are
biologic products.
biologic innovator molecules costs make extreme
pressure on reimbursement systems.
by 2020, USD100 billion market value of biologic
molecules going off patent.
cost per patient USD 15.000 to 250.000 per
year… the world is waiting for a solution!
biologics are seen to be a significant driver of
rising healthcare costs - leading to intense interest
in biosimilars.
KEY GROWTH DRIVERS
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regulators, prescribers, patient knowledge and
confidence level towards the quality and safety of
biosimilars is increasing.
many patent expiries on leading biologics in coming
years.
increasing clarity from regulators and market
stakeholders will facilitate uptake of biosimilar MAbs
wider adoption to manage cost
global regulatory pathway evolving towards greater
harmonization
OUR APPROACH
develop a pipeline of 5 biosimilar monoclonal antibody
for key molecules worldwide
build a state-of-the-art biosimilar production, fill and
finish facility, to develop and produce the products
creation of Alvotech – Alvogen Alliance and use
Alvogen sales and marketing network to market and
distribute the products
out-licensing to local or multi-national players in key
markets where Alvogen does not have presence
aim to cover all territories where the innovator has
market share through partnerships
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BUSINESS HIGHLIGHTS
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IN JUST FIVE YEARS…
transformed from a single market CMO to a
multinational generics firm
present in over 30 countries focused on 3 key
geographic regions
executed on 5 accretive company acquisitions,
and numerous product deals
built a powerful platform in biosimilars with 3
molecules on market and 5 in development
well targeted portfolio across therapeutic areas
and geographies
world-class leadership team
broad manufacturing footprint with outstanding
history of quality
well positioned for further growth and profitability
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