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HYUNDAI PHARM Company Profile n contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

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Page 1: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

HYUNDAI PHARMCompany Profile

The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

Page 2: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

HYUNDAI PHARM GROUP

Chairman & CEO

Chairman : Lee, Han Koo

President : Yoon, Chang Hyun

Established in 1965

Headquarter located in Seoul, Korea

Total employees : over 510

Business area : Pharmaceutical products, Health

food drinks, and Medical equipment & Device

Total revenue in 2011 : 116M USD (1USD=1,000KRW)

Total three manufacturing facilities

Main therapeutic sales : Cardiovascular (40%),

Respiratory (22%), Dermatology (15%), etc.

Page 3: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

RECENT EVENTSNov 2012 Received a gold award for Safety & Quality by the President for the first time

among the pharmaceutical companies in Korea.

Oct 2012 Signed on the marketing and sales agreement of TachoSil®

Jul 2012 Technology transfer agreement signed & in progress to Europe + 30 countries in Central South America & the Middle East & Africa & Asia

Jun 2012 Designated as ATC (Advanced Technology Center) by Ministry of Knowledge Economy for development of new pharmaceutical molecules.

Jun 2012 Selected as one of thirty innovative pharmaceutical companies by government recently, designation offered only to those pharmaceutical company investing in R&D

Oct 2011 Co-promotion agreement of Ocuvite with BauschLomb

Aug 2011 Co-marketing agreement of Tareg/Cotreg & Zilep/Zilep XL with Novartis

Jul 2011 Ella One(Emergency contraceptives) launched

Jun 2011 License-in agreement of Ruping eye drop (artificial tear) with Ophtecs corp, Japan

May 2011 Distribution right agreement of Surfolase in China with Polichem, Switzerland

Feb 2011 IND submission of Levotuss CR tablet

Dec 2010 Completed technology transfer of Galantamine SR to 20 countries including Spain, Portugal and Central & South America

Oct 2010 Exclusive distribution agreement for Natto Balance and Nasal Guard with Nitto Pharma

Jul 2009 IND approval of HD-003(NME)

This is the mark given by the government for se-lected innovative companies

Page 4: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

ORGANIZATION

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DOMESTIC BUSINESS AREA

Pharmaceu-tical Busi-

ness84%

PublicWel-fare1%

Health Food

Drinks 14%

Medical Equip-ment & Devices

1%

Page 6: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

PHARMACEUTICAL BUSI-NESSTotal sales in FY 2011: 100 M.

USD

77.5%

22.5%

OTC

ETC

Others***

CNS

HEMOSTATICS**

OBGY

RESPIRATORY

CVM*

Sharein ETC

33.5%

23.6%

11.8%

11.4%

9.9%

9.8%

*CVM include CV & Endo products**HEMOSTATICS include disinfectants

***Others include GI, Pain, DERM, OPHTALMICs

Source: Internal Data

US$1=1,000won

Page 7: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

ETC BUSINESS in FY 2011

Source: Internal Data

ProductSales (Mil.USD)

TC Originator Note

TENORMIN /TENORETIC

13.3 HYPERTENSION AstraZeneca No.1 B-blocker

TACHOCOMB 8.0 HEMOSTATIC Takeda No.1 Hemostatics

LEVOTUS 7.5 ANTITUSSIVES Dompe No.1 Rx antitussives in PED

SURFOLASE 5.7 EXPECTORANTS Policam No.2 Rx expectorants in IM

SYSCOR ER 4.7 HYPERTENSION Bayer Coat-core technology

ACTIQ 3.4NARCOTIC ANAL-GESICS

TevaOral transmucosal fentanyl citrate

RHINATHIOL 3.2 EXPECTORANTS In-house Long history product

NORLEVO-ONE

2.9 CONTRACEPT HRAFirst contracept after sex in Korea

UREMIN 2.6ANTIDIURETIC HORMONES

In-house First generic in Korea

SALAGEN 2.1 STOMATOLOGICALS EisaiOnly Radiation-Induced Xeros-tomia in Korea

TAMIRIN 2.0ALZHEIMER DIS-EASE

In-house First Galantamine SR in Korea

US$1=1,000won

Page 8: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

OTC BUSINESS in FY 2011

ProductSales (Mil.USD)

TC Note

MINOXYL 8.5 Prevention of alopecia No.1 product in Korea

BUMOOL series 3.0 Antipruritics Long history product

MOOL PAS 1.3 Pain relief Long history product

SOLUFEN 1.4 NSAIDsFast pain killer product as soft capsule

DERMAWHITE 1.4 Whitening Topical No.1 whitening OTC

TONGEJON 1.1 NSAIDs TopicalAntiinflammatory analgesic drug

SINO series 0.6 Cold preparations Long history product

AIRPAS 0.4 Pain relief Spray pas

LIVER 0.4 Liver diseaseHigh contents ofsilymarin formulation

LUPING - Artificial tear New launched in 2012

Source: Internal Data

US$1=1,000won

Page 9: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

PHARMACEUTICAL BUSI-NESS

•Co-development of innovative drugs

•Co-marketing/promo•Joint Ventures•Global clinical trials

•Out-license of in-house developed products ( NME / IMD )

•Technical licensing out of platform tech-nologies

• Global IP right se-curement

• Consulting services• Global research

center

• In-license, co- de-velopment product

• In-licensing of novel tech

In-li-cense R&D

Collabora-tion

Out-li-cense

Cross-license

Page 11: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

GLOBAL NETWORK (In-Licens-ing)Partner Product

Action/Indica-tion

Takeda (Nycomed)

Tachocomb

Hemostatic

Mitsubishi Tanabe

Galan-tase

Dyspepsia caused by Chil-dren’s lactose In-tolerance

Novastan Hi

Thrombosis, Heparin Induced Thrombocytope-nia

Alegysal

Bronchial Asthma, Peren-nial Allergic Rhinitis

Kowa Hypadil Glaucoma, Ocular Hypertension

Eisai Salagen Radiation-In-duced Xerostomia

NittoNatto Balance

Intestinal Disor-ders

Ophtecs Ruping Eye Drop

Partner ProductAction/Indica-tion

Astra Zeneca

Tenormin Hypertension

Bausch & Lomb

Ocuvite Ophthalmological

Teva (Cephalon)

Actiq oral tab

Analgesic(Opiate agonist)

NovartisTareg /Co-tareg

CV (Valsartan etc)

Policam S.A

Surfolase in China

ExpectorantRespiratory

Dompe Levotuss Cough: Acute and Chronic Bronchitis

HRA Farma

EllaOne

Emergency contra-ceptives(Effective even af-ter 120hr)

Bayer Schering

Syscor ER Hypertension

Page 12: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

GLOBAL NETWORK (Out-li-censing)

Product Country Current Status

Pramipexole SR

Europe +30 countriesin Central South America &the Middle East &Africa & Asia

Agreement signed &Technology transferin progress

Galantamine SR

20 countries includ-ing Spain, Portugal and Central & South America

Technology transfer completed

Pramipexole SR Australia

Under negotiation

Levetiracetam IR Indonesia

Telmisartan + HCTZ

Turkey, Indonesia

Ibandronate Indonesia

Tamsulosin CR / OD

Indonesia

Esomeprazole Indonesia

◆ Overseas technology transfer from 2010 to 2012◆ Domestic out-licensing from 2010 to 2012

Product Company

Iban-dronate

15 companies including Je-il

Lamotrig-ine

3 companies including Il-dong

Amlodipine + Valsar-tan

8 companies including Han-dok

Adefovir6 companies including Choong-wae

Lamivudine2 companies including Dong-koo

Olmesartan Kolon pharm

Olanzapine2 companies including Dong-wha

Pitavastatin11 companies including Whan-in

Telmisartan Kolmar Korea

Page 13: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

Expected Growth Rate: 2012 – 7.4%2013 4.2%2014 5.3%2015 6.7%

2010 Korea Pharmaceutical market

$11 B with 10% GR

11th Largest Pharma market

4th largest economy in Asia

Among 10 new drug developers in the world

KOREAN PHARMACEUTICAL MARKET in 2012

Source: Data monitor international

Series10

20

40

60

80

100

SaleProfit

2010 2011 Exp.2012

2010.11Rebate Ban

2012.3New Drug

Pricing

2015.Q1USA-FTA

Profit squeezing & Reorganization of Pharma industry

%

Source: Hana investment security, Pharmaceutical industry report

Page 14: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

INVESTMENT for R&D

◆ Reinforce GMP & information infra

◆ Excellent research ability

◆ Dedicate to NME & IMD

4.3

6.0 5.8 6.7

%: Against total revenueCurrency : US Dollar/ Unit : Mil-lion

4.3%5.6% 5.3%

5.5%

8.7%

'07 '08 '09 '10 '11

Annual Investment Growth:22%↑

Se-ries1

0.5 0.25 0.17

0.03 0.1

1.7

2.3

Se-ries1

0.42

10.75 0.75 0.75

0.58 0.6

1.2

'07 '08 '09 '10 '11

Research invest-ment

Facility invest-ment

NMEIMD

Page 15: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

R&D CENTERS

R&D center (Seoul)

• Team : Project Planning Patent Planning DDS development Generics develop-ment Analysis

• Project : Generics, IMD* development, Pre-formulation of NCE

R&D center (Suwon)

• Team : Synthesis 1 Synthesis 2 Pharmacology Toxicology Pharmacokinetics

• Project : NCE* devel-opment

• IMD: Incrementally Modified Drug• NCE: New Chemical Entity

R&D center (Yong-In)

• Team : Safety and effi cacy test Animal test (rat, bea-gle) • Project : pre-clinical test

・ 2012. 06 Designated as ATC (Advanced Technology Center) by Ministry of Knowledge Economy for development of new pharmaceutical molecules.

Page 16: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

PIPELINE

NoveltyCompeti-

tive advan-tage

Market Po-tential

Regulatory context

Few Ad-verse Ef-

fects

Better Compliance

Market Po-tential

Regulatory context

NewMolecularEntities

IMDs

Page 17: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

PIPELINE_NME

Prod-uct

Indica-tion

DS PC

Clinical Trials

P I P II P III

HD003 Anti-

oxidant

Chronic

Renal

Failure

HOB04

6

11Beta

HSD1

in-

hibitor

Type 2

Dia-

betes

HOB04

7

GPR11

9 Ago-

nist

Type 2

Dia-

betes

* Added by Chinese source:S122 & B170 for Cancer, BPI 1500 for Anemia, TM135 for DB

Domestic Venture

Domestic Academy

International Venture

International Academy

Page 18: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

PIPELINE_IMDs

CATERIA PRODUCTS ACTION INDICATION DEVELOPMENT STATUS

Aripiprazole IR AntipsychoticsAcute manic and mixedepisodes associatedwith bipolar disorder

Launch ready(expected in Feb, 2014)

Donepezil HCl SR AnticholinesterasesDementia fromAlzheimer’s disease

Finished the formulation study

Levetiracetam

SR

Antiepileptics Epilepsy

Finished the formulation study

IRLaunch ready(expected in Jan, 2013)

Mirtazapine IR TCA DepressionLaunch ready (expected in Dec, 2012)

Pramipexole HClSR

Dopamine agonists Parkinson’s Disease

Launch ready(expected in May, 2013)

IR BE ready

Choline alfoscerateSR

Parasympathomimetic Cognitive disorderPhase I ready

IR BE ready

Lacosamide SRvoltage-gated sodium channels

epilepsy Pre Clinical

Fentanyl citratetrans mu-

cosalPhenylpiperidine deri-vative

Narcotic analgesic In fomulation Study

Acebrophylline SR Muco-active Respiratory disease Phase I

Levodropropizine SRperipheral antitus-sive

Cough Launch ready

Oncology Imatinib mesylate Mini-tablettyrosine kinase in-hibitor

chronic myelogenous leukemia

In fomulation Study

Page 19: The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm

PIPELINE_IMDs

CATERIA PRODUCTS ACTION INDICATION DEVELOPMENT STATUS

Ibandronate IR Bisphosphonate Osteoporosis Launched in August, 2012

Telmisartan + HCTZ COMAngiotensin II antago-nist

Hypertension Finished the formulation study

Valsartan + Amlodipine COMAngiotensin II antago-nist

HypertensionLaunch Ready(In process of product approval)

Tamsulosin CR / ODAlpha adrenoreceptor antagonist

BPH BE Ready

Dutasteride Weekly5-alpha-reductase inhibitor

Alopecia Pre Clinical

Ecabet + Ranitidine COMAntiulcerant Mucosal protection

Gastroduodenal Ulcer

Pre Clinical

Esomeprazole OD proton pump inhibitorgastro esophageal reflux disease

In fomulation Study

Clindamycin+Adapalene COM antibiotic+retinoidMild to moderate acne

Pre Clinical

HOB-060 TopicalSynthetic derivative ofthe amino acid

Whitening In fomulation Study