2017 COMPANY PRESENTSTION Healthful WORLD! Dynamic DAEHWA!
Copyright 2017 DAEHWA Pharmaceutical Co., Ltd. All pictures cannot be copied and revised without permission.
Contents
Company Overview Main Business R&D VISION 2020
2
Company Overview
3
Value Vision Company History Company Introduction
4
Value Vision
As value of company DAEHWA, certified as innovative pharmaceutical company by MoHW, has established solid foundation as the high-potential mid-sized enterprise. Also, with the better value created by continued management innovation, We do our best to be the global pharmaceutical company in the world.
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Value Vision
As purpose of company With philosophy of respecting life and thinking environment-friendly, DAEHWA tries to contribute to the health and well-being of the human race with advanced technology that leads pharmaceutical industry.
6
Value Vision
Company History Company Introduction
7
Company History
Beginning Of business
Growth period
‘84/01 Established on Jan. 19, 1984 ‘86/03 Soo-Ji Kim and Woon-Jang Kim were inaugurated as CEO ‘87/07 Selected as promising small-medium sized company (The institute for Chemical Research)
1st Quantum leap
2nd Quantum leap
Company History
Beginning Of business
Growth period
1st Quantum leap
‘01/08 Designated as promising “Venture company” (Technical evaluation) ‘01/12 Establishing new drug research institute ‘02/11 Purchasing Hoengseong Factory area
2nd Quantum leap
Company History
Beginning Of business
Growth period
‘03/02 Listed in KOSDAQ market ‘03/02 Completed office building in Daejeon ‘04/07 Added C-Tri Pharmaceutical Co. as affiliation ‘06/09 Completed merging of DS&G Pharmaceutical Co.
‘07/05 Added DH Horim Company as subsidiaries (Drug wholesaler) ‘07/07 Added S-Med Corp. as subsidiaries (Medical contents supplier)
‘08/01 Approved Liporaxel® phase Ⅰ clinical trial(MFDS) 1st
factory as cGMP(MFDS) for oral ‘09/11 Got the approval of Formulation and external ointment, gel and creams
1st Quantum leap
2nd Quantum leap
‘10/06 Approved Liporaxel® phase Ⅱ clinical trial(MFDS) ‘11/04 Got the approval of 2nd factory as cGMP(MFDS) For TDDS products ‘11/08 Newly opened Pankyo R&D Center ‘11/12 Liporaxel® approved as NET (New Excellent Technology) by MoHW ‘12/06 Certified as Innovative Pharmaceutical Company By MoHW ‘13/02 Approved Liporaxel® phase Ⅲ clinical trial(MFDS) ‘13/05 Liporaxel® designated subject of a research by MOTIE ‘13/08 Takeover Redox-Bio Corp.
Company History
Beginning Of business
Growth period
1st Quantum leap
2nd Quantum leap
‘15/02 Liporaxel® Re-approved as NET(New Excellent Technology) by MoHW
‘15/12 Affiliate company, C-tri Listed on the KOSDAQ
‘15/06 Beginning construction of anticancer factory which is dedicated for Liporaxel®
‘16/03 DH1401 Designated as Advanced medical technology development project by MoHW
‘15/06 Re-certified as Innovative pharmaceutical company(MoHW)
‘16/08 Purchasing new office building in Bangbae to move
‘15/10 Completed construction of anticancer factory which is dedicated for Liporaxel®
‘16/09 Liporaxel® approved by MFDS as world firstly
‘15/11 Finalizing Liporaxel® phase Ⅲ clinical trial
‘16/12 DH1401 Started phase Ⅱ clinical trial
‘15/12 Got the 5 million dollar exporting prized from Government
Value Vision Company History
Company Introduction
12
Company Introduction
COMPANY NAME
DAEHWA PHARMACEUTICAL CO., LTE.
FOUNDATION DATE
JAN. 19TH 1984
CEO
Byung-Tae Noh / Eun-Seok Kim
KOSDAQ LISTED DATE
FEB. 12TH 2003
STOCK
18,224,974
CAPITAL
9,112,487,000KRW(USD 8,000,000)
ADDRESS
495, Hanu-ro, Hoengseong-eup, Hoengseong-gun, Gangwon-do, Republic of Korea
EMPLOYERS
About 350 people
WEBSITE
www.dhpharm.co.kr
MAIN PRODUCTS
CEPHAMETHYL tab. FLOSPAN tab. CEFACLOR cap. AMALIAN filler
Company Introduction CEO
Chairman & CEO
Byung-Tae Noh Academic background Bachelor’s in manufacturing design at Daegu Univ.
President & CEO
Eun-Seok Kim Academic background Bachelor’s in Psychology at Sungkyunkwan Univ. MBA at Sungkyunkwan Univ.
Career
Career
DAEHWA Pharmaceutical Co., Ltd.
BUKWANG Pharmaceutical Co., Ltd. DAWHWA Pharmaceutical Co., Ltd. 14
Company Introduction
CEO
Organization chart
(Chairman) Full time auditor
Board of directors
CEO (President)
Business Management HQ
Seoul sales ∙Marketing HQ
General affairs
Gangnam 1,2,3
Busan
Finance & accounting
Gangbuk 1,2,3,4
Daejeon
Information system
Gyeonggi 1,2
Gwangju
Province sales HQ
Legal
Incheon 1,2
Daegu
Advertising
Sales management
Jeonju
Marketing
General hospital /Wholesales HQ Hospital 1∙2∙3
Wholesales
DDS sales HQ
Production HQ
R&D HQ
DDS sales
1st factory
Central research center
CMO
2nd factory
Pankyo research center
3rd factory
Development
Clinical research
Overseas Business
Company Introduction Affiliates status
DH HORIM
REDOX-BIO
SHARE RATIO : 61.91% MAIN BUSINESS : Pharmaceutical Domestic Wholesaler
SHARE RATIO : 59.58% MAIN BUSINESS : Produce HA and synthesizing APIs Development of medical device and related Trading SHARE RATIO : 61.24%
S-MED
C-TRI
(Listed in KOSDAQ)
MAIN BUSINESS : Medical Information System Contents Service SHARE RATIO : 12.82% MAIN BUSINESS : R&D and Pharmaceutical manufacturer focusing on Bio products (Peptide related)
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Company Introduction
R&D center
Office building
Seoul
Daejeon
Pankyo
Head office/Facilities
Head office/ 1st Factory
2nd Factory
3rd Factory
Central
Factory Introduction
Hoengseong
1st 2nd factory 18
Factory Introduction
2nd factory 1st
Maintenance building
factory
Management building
Hoengseong
1st 2nd factory 19
Factory Introduction
Hoengseong
3rd factory
Factory Introduction
1st factory
Square measure
2nd factory
Manufacturing site : 3,900㎡
Manufacturing site : 1,971㎡
Manufacturing site : 259.1㎡
Storage : 1,318㎡
Storage : 846㎡
Storage : 12.7㎡
Quality control site : 684㎡
Others : 1,575㎡
Quality control site : 10.2㎡
Others : 5,128㎡
Total : 4,392㎡
Others : 306.8㎡ Total : 588.8㎡
Total : 11,030㎡
Dosage form of product
Capacity (per year)
3rd factory
Oral formulation(tablet, capsule)
Plaster, cataplasma, patch
Oral solution
Tablet 600,000,000 tablets
Plaster 52,500,000 sheets
1,800,000 vials
Capsule 120,000,000 capsules
Cataplasma 36,000,000 sheets
Ointment(Gel, Cream) 50 tons
Patch 12,000,000 sheets
Ointment(ointment, cream, gel) ODF
Factory Introduction Product category
9% Aseptic preparation as injection Ceftriaxone sodium inj. 1g
8% Ointment(Gel, Cream) Kebanon gel, Demacot-s cream, Softia ointment etc.
Cefuroxime sodium inj. 1.5g etc.
13% TDDS patches Hyemingo cataplasma, Loxona plaster Resnalin patch etc.
66% Oral formulation Flospan tab. Cephamethyl tab.,
4%
Cephamethyl cap., Gastric Cap. etc.
Others Suppository, diagnosis reagent, Sanitary aid etc. 22
Pankyo Research Center
Research of LASED/TDDS/BIO/natural products Research of LASED(Lipid-bAsed Self-Emulsifying Drug) Research of IMD & New Dosage Form Anti-cancer, Antivirus and ODF
Research of Natural Products and Health Supplements Dementia treatment, improvement of recognition and blood pressure Research of Transdermal Drug Delivery System Patches (Patch / Plaster / Cataplasma)
Supporting of building on Product dossiers Preparing CTD and conducting MV
Central Research Center
Formulation Study Formulation study of IMD and Generic Focus on oral dosage formulation study (IMD & Generic)
Formulation study and Pilot study Support of building on products dossiers LASED Scale-up Study
Main Business
25
Business Overview ETC/ OTC etc
Business Strategy
26
Business Overview
OTC
ETC
29.8%
Total 130 items
TDDS(OEM)
Antibiotics, Digestive MAIN PRODUCTS
Total 50 items
62.2%
MAIN PRODUCTS
1H 2016 USD 35,826,000
Anti-imflammatory Patches 1H16 USD7,139,130
Cephamethyl Anti-biotics 1H16 USD 4,034,782
5%
Flospan Gl(Antispasmodic) 1H16 USD2,139,130
Medical device Amalian
Filler(Medical device) 1H16 USD1,000,000 ETC
OTC
Others
Business Overview
2016 FIRST HALF YEAR SALES PROPERTY
OVERSEAS
$1.6Mil.
TDDS
ANTIBIOTICS
(M/S of external Patches as 65%)
ETC
$7.6Mil.
$26.6Mil.
SALES (Growing 13.6% Compared to last first half year)
$35.9Mil.
Business Overview
2016 FIRST HALF YEAR SALES PROPERTY
Focusing on prescription drug products OVERSEAS
$1.6Mil.
Specialized Pharmaceutical Company TDDS
ANTIBIOTICS
(M/S of external Patches as 65%)
ETC
$7.6Mil.
$26.6Mil.
SALES (Growing 13.6% Compared to last first half year)
$35.9Mil.
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Business Overview
ETC/ OTC etc Business Strategy
30
ETC/OTC etc
ETC
ETC` Infectious disease
6,226,086 4,782,608
Digestive disease
3,434,782
Cardiovascular OEM Anti-inflammatory Respiratory disease others
OTC
OTC
(Unit : USD)
3,400,000
(Unit : USD)
External application (OEM)
6,626,086 3,191,304
OTC etc.
756,521 1,895,652
1,652,173 1,078,260 2,817,391
ETC Antibiotics Sales USD 6,260,869 External application(patches) Sales etc. USD 7,391,304
External application (Own business)
Medical device etc
ETC/OTC etc
ETC
ETC` Infectious disease Digestive disease Cardiovascular OEM
6,226,086
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4,782,608 3,434,782 3,400,000
Million 1,652,173 USD
OTC
OTC
(Unit : USD)
External application (OEM)
6,626,086 3,191,304
12
756,521
others
OTC etc.
External application (Own business)
Million USD Medical device etc
1,895,652
Anti-inflammatory
Respiratory disease
(Unit : USD)
1,078,260 2,817,391
ETC Antibiotics Sales USD 6,260,869 External application(patches) Sales etc. USD 7,391,304
Business Overview ETC/ OTC etc
Business Strategy
33
Business Strategy Domestic
Focusing on development of long term prescription Drugs and marketing Cardiovascular / Endocrine disease(hypertension, diabetes) etc
Strengthen sales by selection and concentration strategy Strategically selecting ETC products and doing concentrated marketing
Strengthen development on ETC patches product pipeline Enhancement of network and relationship with leading company
Diversification of sales Extension of business fields like medical device(Amalian) and so on
34
Business Strategy Domestic
Advanced to Cosmetic & Plastic beauty market
Developing TDDS formulations
2015 sales turnover USD 1,913,043
Largest transdermal OEM company in Korea (For 29 companies : Yuhan, CKD, Ildong, Boryong, Ilyang etc)
2016 sales objective USD 3,130,434
TDDS Sales turnover USD 14,000,000
Reinforce ON and OFF line marketing
2 ETC Patches was launched
Line extension related to Hyaluronic acid
Developing ETC patch narcotic analgesics, smoking cessation, Urinary incontinence etc
Amalian filler was launched on Feb. of 2014
(Cosmetic, Adhesion preventions etc)
Target marketing to Drugstore and CVS
2017’s sales goal
2017’s sales goal
35
Business Strategy Overseas
Exporting to 20 countries Additional 28 countries are in progress
Export award USD 5M from government
A contract with big market player Preparing of entering to China, US, Europe and middle east
Technical transfer of TDDS / Planning of building overseas manufacturing facilities Iran, China
36
Business Strategy Overseas Distribution contract with Prorepharm
US
CHINA
Distribution contract with Zhijun Pharmaceutical Co.(Launching target as 2018)
Preparing for US cGMP Preparing for US registration
Middle East Malaysia Technical transfer contract with ATRA UAE and other 10 countries : Supplies agreements with NOVOSCI
Distribution contract with Ocean One Pharma (BIDICA and 9 products)
Business Strategy Overseas
Europe
France, Bulgaria, etc
America
USA, Bolivia, Ecuador, etc
Asia
Africa
Ethiopia, Ghana, Algeria, etc
48 countries
China, Myanmar, Vietnam, Cambodia, Philippines, Thailand, Mongolia, Iran, etc
R&D
39
R&D OVERVIEW DH-LASED NATURAL DRUG PRODUCT
OTHERS (TDDS, ODF) 40
R&D OVERVIEW R&D Networks Pankyo Research center
Central Research Center Formulation Study
Formulation study & development
Pilot Study and Formulation development
LASED study
Support and product registration Scale-up for LASED technique product
IMD study (Oral solid form)
R&D Networks
Transdermal Drug Delivery System Natural new drug IMD study Antibody new drug
Redox-Bio Synthesize study (High purity HA & API )
Synthesize study of raw material Process development IMD synthesize study High purity HA product
C-tri Research center R&D on Bio/Synthesizing Peptide/Antibody
Cooperation organization KAIST ASAN MEDICAL CENTER Kyunhee univ Catholic univ Seoul national univ Dongguk univ Chung-ang univ
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R&D OVERVIEW PIPELINE Product Name
Code name
[Oct. 2016] Indication
Liporaxel® (DHP107, Paclitaxel Oral Solution) DHP107
Gastric cancer
- DHP107A
Breast cancer (domestic)
- DHP107B
Breast cancer (overseas)
DH-LASED DHP21001 DHP23001
Solid Tumor
DHP23002
Solid Tumor
DHP23007
Anti-virus
DHP33001
Diabetes
DHP1401
Dementia
DH-BIO/ DHP32001 HERBAL DHP32002 DHP42001&42002 DHP26001 DH-ODF DHP26002
DH-TDDS
Solid Tumor
ALS Rare disease
Solid Tumor Impotence Antiemetics
DHP26007
Hepatitis B
DHP26003
Narcotic Analogesics
DHP26005
Dementia
DHP27006
Urtication
DHP27008&27010
Inflammation
Research
Nonclinical
Clinical PhaseⅠ
PhaseⅡ
임 상
PhaseⅢ
Approval
Marketing
R&D OVERVIEW
DH-LASED NATURAL DRUG PRODUCT
OTHERS (TDDS, ODF) 43
DH-LASED Based technique
DH-LASED DaeHwa Lipid bAsed Self Emulsifying Drug delivery technology Magic Bullet Weak absorption drug
Insoluble drug Unmet needs drug
DH-LASED
Old-fashioned drug
DH-LASED is highly potential !!
Innovative drug controlled market
DH-LASED / Liporaxel®(DHP107) History and plan Development of DHP107 dosage form
DREAM study
GOFDA Project
(Informational patent)
2006
2008
2010
2013
2015
2016
2017
Launch Liporaxel® GLP Non-clinical (Covance, KIT
Clinical phaseⅠ (AMC)
Clinical phaseⅡ (AMC)
Clinical phaseⅢ (12institution)
Finalized Clinical study
(DHP107)
Approved License Liporaxel® (DHP107) by MFDS
Add indication Start clinical study
Start US clinical study
DH-LASED / Liporaxel®(DHP107) STRONG POINTS
Taxol@ (Intravenous Injection)
DHP107
Convenience
Require hospitalization
Home care
Diluting agent
Severe hypersensitivity caused By Cremopher EL
Using edible oils, no hypersensitivity
Over 3hours
Single-dose by oral
Needed
No needed
Administration Intravenous administration
Premedication
1 cycle
3 Weeks
4 Weeks
Sole oral formulation
The world’s first single oral dosage formulation of paclitaxel Improving
quality of Patient’s life
Better safety
(3W on, 1W off)
46
DH-LASED / Liporaxel®(DHP107) MASTER PLAN OF OVERSEAS DEVELOPMENT
2016
2020
Get the approval on world’s 1st oral paclitaxel product
The first year of GLOBAL DAEHWA pharmaceutical
Raising value of DAEHWA’s
Maximizing value of
Brand name
DAEHWA’s brand name
Liporaxel® Domestic Approval
Export to More than 5 Countries abroad
Export to More than 20 Countries abroad
2025
Sales of Whole world would be Exceeding 1trillion won Per year
2030 Take the 40% of market Portion in whole paclitaxel market
Sales would be coming from all contracted countries Settlement of virtuous cycle structure from ordinary profit to R&D
47
DH-LASED / Other project Under going project based on DH-LASED
DHP23002 DHP23003
DHP21001
Oral solid cancer
Oral solid cancer Oral solid cancer
First Oral paclitaxel on the world
Oral solid cancer
DHP23005 DHP23006
DHP42001
Oral solid cancer
Oral solid cancer
Oral diabetes
LiporaxelÂŽ (DHP107)
DHP23001 DHP23006
DHP33001
Oral solid cancer
Oral solid cancer
DHP23007 Oral antivirus
R&D OVERVIEW DH-LASED
NATURAL DRUG PRODUCT OTHERS (TDDS, ODF) 49
NATURAL DRUG PRODUCT Natural drug development for Dementia treatment Launching target as 2022 Confirming efficacy of memory improvement on Dementia model Passive Avoidance Test
β-Amyloid protein injection method
Intracerebroventricular Injection(3�)
Ref.) Biomol Ther. (Seoul) 2013 Jul. 30;21(4):299~306
50
NATURAL HEALTH FUNCTIONAL FOOD Health functional food development on Memory improvement for preparing Aging society
Launching target as 2018 Confirming efficacy of recognition ability improvement (in vivo) Passive Avoidance Test
Y-maze Test
Ref.) Ministry of Agriculture, Food and Rural Affairs, Higher value-added food technology development business, Development subject of health supplement which contains 51 active ingredients as Spine date seed for memory improvement of adults to prepare an aging society.
R&D OVERVIEW DH-LASED NATURAL DRUG PRODUCT
OTHERS (TDDS, ODF) 52
OTHERS TDDS
Plaster
Transdermal Drug
Cataplasma
Delivery System
Entry stage 01.1-06.12
Building Research and Business System
Growing stage 07.1-11.12
Establishment of foundation for growing and leaping
Transdermal Drug Delivery System Advance to Global Market
Quantum leap 12.1-20.12
Advance to Global Market
Laboratory Establishment
Product item Expansion and
Strategic product development
Acquiring source core technology
Business Diversification
for Global Market
Release of Plaster products
Development of new growth engine
Constructing Partnership with Multi-
By strengthening R&D Investment
National pharmaceutical companies
53
OTHERS TDDS, ODF Ketoprofen Plaster
2002
Traditional Chemical Cataplasma
2004
SMEDDS Technology Development
2006
Loxoprofen Patch First in Korea (Loxona)
2008
Narcotic analgesic Dementia treating Fentanyl Patch medicine Development development (Dufenyl) (Rivamensa Patch)
2010
Plaster development All-in-One Tulobuterol Patch Of Hot-melt Type Cataplasma (Resnalin) Development And Production System build-up
2012
BeKool Itch Relief Patch
2014
2016
Roll Type plaster Coin plaster Production & development
OTHERS Vision of TDDS
Needle Manufacturing Technology
Applying to New drug
Healthcare / Cosmetic
Base Adhesive
Hot-melt Patch Technology
Biodegradable macromolecules
Applying to
Microneedle
New drug
Technology Drug Application Technology
Healthcare / Cosmetic
55
OTHERS ODF Special merits
Fast Disintegration, Fast Dissolution ODFilm Administration without water
Convenient for children and elderly
Fast medicinal effect
56
OTHERS Vision of ODF / DH-ODF platform Development
DHFast film DHDHSlow film Muco film
Establishment of patients Customized drug delivery System ODF platform Technology.
57
58
R&D
Market advance to Beauty and Cosmetic surgery
Overseas Market
59
Liporaxel® (DHP107) Finalized Phase Ⅲ clinical trial Overseas Licensing-out progress Approved license by MFDS in 2016
R&D
Launch in 2017 Application of US FDA clinical IND Ⅰ& Ⅲ for breast cancer
REDOX-BIO CO., LTD
Market advance to Beauty and Cosmetic surgery
Acquired 100% of SHARE RATIO on Aug, 2013 Hyaluronic acid Manufacturing Facility build-up Certified for EU GMP(Germany) For Hyaluronic acid Sales Goal: USD 26M (within 3 years) Acquirement of DAEHWA Hyangnam factory Expand area with cosmetic production Capital increase for value to third party Target 13M sales in 2018 / IPO in 2020
DHP1401 (Natural dementia medicine) DHP1401 indication & mechanism study Safety establishment through toxicity test Set up the manufacturing process of raw material & finished product Clinical trial II IND approval by MFDS on Aug. 2015 Domestic patent 2 , overseas patent 8 cases
Amalian Filler Hyaluronic acid as raw material Domestic Market Scale: USD 87M Additional portfolio for Amalian With Lidocaine, SCM2, TheraSTem-Derma and so on
National Project 7 National Projects including Anti-cancer drug Total Business Expense: USD 10M The Government Grants: USD 7M
Focusing On Overseas Market expansion
TDDS Product Various specialized product Release Export to Product and Technology
Focusing on Overseas Market expansion Advance to Large Market including China, America, Europe and so on Diversification (Technology transfer and foundation of Joint-stock Company and so on)
61
Healthful WORLD! Dynamic DAEHWA!
DAEHWA makes every effort to provide accurate and up-to-date information and due care has been used in preparation of this presentation. Nevertheless, this presentation may be subject to technical inaccuracies, information that is not up-to-date or typographical errors. DAEHWA does not assume liability for relevance, accuracy and completeness of the information provided. DAEHWA reserves the right to change, supplement, or delete some or all of the information on this presentation without notice.
Content point Address Attn
DAEHWA Bldg., 2145 Nambusunhwan-ro., Seocho-gu, Seoul, Republic of korea Overseas Business Dept.
Website
www.dhpharm.co.kr
Tel
+82-2-6716-1071~4
Fax
+82-2-588-3422