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BUILDING A TOP 10 GLOBAL GENERICS PLAYER 20 November 2014 1
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Page 1: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

BUILDING A TOP 10 GLOBAL GENERICS PLAYER

20 November 2014 1

Page 2: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

CONTENT

OVERVIEW

Alvogen worldwide

Regional focus

Biopharmaceuticals

Highlights

Page I 2

Page 3: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

ALVOGEN TEAM HERE TODAY

Page I 3

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)

Page 4: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 4

Page 5: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

Page I 5

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™

Page 6: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

ALVOGEN IN NUMBERS

Page I 6

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

Page 7: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 7

USA 48% CEE 22% APAC 30%

Page 8: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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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Page 9: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

TARGETED PRODUCT PIPELINE

Page I 9

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

Page 10: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 10

Page 11: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 11

SVAFA KEVIN RENAAT

GEORG

CHRIS

ARNI LISA FJALAR

THOR PETAR BILL

ROBERT

Page 12: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 12Page I 12

Page 13: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

REGIONAL

FOCUS

Page I 13

Page 14: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 14

Page 15: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

AWARD WINNING TEAM

Page I 15

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)

Page 16: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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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Page 17: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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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Page 18: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

BIOPHARMACEUTICALS

Page I 18

Page 19: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

BIOPHARMACEUTICALS

ARE THE FUTURE

Page I 19

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.

Page 20: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

KEY GROWTH DRIVERS

Page I 20

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

Page 21: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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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Page 22: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

BUSINESS HIGHLIGHTS

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Page 23: BUILDING A TOP 10 GLOBAL GENERICS PLAYER · built a powerful platform in biosimilars with 3 molecules on market and 5 in development well targeted portfolio across therapeutic areas

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

Page I 23


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