GREEN CROSS · This presentation may contain forward-looking statements. Forward-looking statements...
Transcript of GREEN CROSS · This presentation may contain forward-looking statements. Forward-looking statements...
JP Morgan Healthcare Conference
11 January 2017
Eun Chul Huh, Ph.D., President
GREEN CROSS
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This presentation may contain forward-looking statements. Forward-looking statements give the
Company’s current expectations or forecasts of future events
The Company cautions investors that a number of important factors, including those in this document,
could cause actual results to differ materially from those expressed or implied in any forward-looking
statement. Nothing in this document should be constructed as a profit forecast.
Other than in accordance with its legal or regulatory obligations, the Company undertakes no
obligation to update any forward-looking statements, whether as a result of new information, future
events or otherwise.
Forward-Looking Statements
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A Leading Biopharma Company in Korea
Overview
FinancialHighlights
Founded in 1967 and listed on KRX in 1978
The largest plasma products manufacturer in Asia
Leading Flu Vx supplier in Korea and pooled procurement by the PAHO
2015 marked as the 43rd consecutive profitable year
$0.5B Investment for Plasma and Vx Businesses for the past 5 years
2015 Sales No.3 in Korea
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80%
20%
Green Cross Others
Domestic M/S
50% 50%
Green Cross Others
Plasma
Flu Vx
No.1
No.1
926
775
998
858
1,164
628
742
572 524 541
2015 2016.Q3
Green Cross Yuhan Hanmi Daewoong CKD
Unit : M USD
Sales
No.2
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Green Cross Position in Korea
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3 Launches
11 Submissions
6 Approvals
GC Flu Quadrivalent in Korea
The first and only locally produced H5N1 AI vaccine
The first and only locally produced Td vaccine
GC Flu Quadrivalent(single) prequalified by the WHO
IVIG SN 10% Ph-III IND (Canada)
IVIG SN 10% BLA (Korea)
GreenGene-F Ph-III IND (China)
Key Milestones in 2016
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2015 2014 2013 2012
Sales 926 862 785 717
Operating Profit 81 86 70 66
Net Profit 85 77 64 49
R&D Expenditure(% of Sales)
87(9.4%)
68(7.9%)
63(8.0%)
61(8.5%)
*Unit : million USD, consolidated
Expect for 2016, to reach double-digit revenue growth with increasing the R&D investment
Financial Performance
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13 Launches
11 Submissions
10 Approvals
IVIG SN 10% (KR)
Adult Td vaccine
IVIG SN 5% BLA Re-submission (US)
IVIG SN 10% IND for Ph-III (US)
HBIG-gene_Liver Transplantation_Ph-III IND (Korea)
EGFR mAb_Gastric & Colon Cancer Ph-1b/2a IND (Korea)
GC Flu Quadrivalent (multi) prequalified by the WHO
Expected Key Milestones in 2017
Sustain Local Leadershipin Plasma & Vaccine
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Building StrongFoundation
Operational Excellencewith Biologics
1970s 1990s
First BiologicsBusiness in Korea
Global Scale Operation & Innovative Medicines
2020s
SustainableDelivery and Growth
2010s
Expansion toEmerging Market
Delivering onReturn to Growth
On Track for Long Term Growth
70%
30%
1970`s 1980`s 1990`s 2000`s 2010`s 2020`s
Vaccines
Specialty
Sustain LocalLeadership
Build CompetitiveGlobal Position
Local Emerging InternationalPlasma
80%
20%90%
10%
Local International
2011`
2016`
Substantial Growth Potential
2020`(E)
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Strategic Outlook
Plasma Business: STRATEGIC ROADMAP to create compelling integration
Flu Vaccine Business: NEW OPERATIONAL MODEL to drive focus
What’s Next in R&D : SUSTAINABLE INNOVATION poised for long term value
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2
3
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3 PRIORITIES
Plasma Business: STRATEGIC ROADMAP to create compelling integration
Flu Vaccine Business: NEW OPERATIONAL MODEL to drive focus
What’s Next in R&D : SUSTAINABLE INNOVATION poised for long term value
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2
3
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3 PRIORITIES
0.4 0.40.5
0.60.7
0.80.9
1.01.1
1.6 1.6
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Production Capa.
Sourcing
CANADA
1.0 Mℓ
1.7 Mℓ
2.7 Mℓ
Sourcing
KOREA + CHINA KOREA ×2
30 Plasma collection centersworldwide
Production3 Manufacturing PlantsIn 3 Countries
Commercial
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Portfolio
Alb.IVIGFⅧ+By Products
Upgrade US, CanadaIVIGAlb.
16 Products KORChinaEmerging
Extra US, CanadaPCCFibrinogen
Building a durable and more profitable business With principal products
Branch office in IndiaWholesaler in CHINA
Sales Company in US (E)
EmergingCHINA
KOREA USCANADA
Toll Manufacturing Services in Canada
Local leadershipIn Plasma
1970s
2020s
Plasma Business Strategic Roadmap
Sourcing
30 by 2020 in US30 Plasma collection centers worldwide
San Bernardino
Calexico
Laredo
Twin Falls
Eagle Pass
Pullman
San Antonio
Leonvalley
2009 Established GCAM
San Bernardino
Calexico
Laredo
Eagle Pass
Pullman
Twinfalls
San Antonio
Leonvalley
+ 20 Centers
2013
2014
2015
2020
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Extensive Investment in Plasma Collection
Production
3 Manufacturing Plants in 3 Countries
Location : O`Chang in KoreaCapa. : 0.7 Mℓ + 0.7 Mℓ (2017)
Location : Anhui in ChinaCapa. : 0.3 Mℓ
Location : Quebec in CanadaCapa. : 1.0 Mℓ (2019)
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Extensive Investment in Production Sites
Global Plasma Market[Unit: $ M]
0
4,000
8,000
12,000
16,000
'14 '15 '16E '18E '20E '22E '24E
US IVIG Market
13.2
10.6
0
1,000
2,000
3,000
4,000
5,000
'14 '15 '16E '18E '20E '22E '24E
China Albumin Market
Reference: Marketing Research Bureau, A.T. Kearney Analysis 2014
[Unit: $ M]
0
5,000
10,000
15,000
20,000
25,000
30,000
'12 '14 '16E '18E '20E 22E 24E
CAGR 6% CAGR 10%
CAGR 12%
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Commercial
CHINA - High demand of Albumin (CAGR 12%)
US - The world`s largest IVIG Market (CAGR 10%)
CHINA
CANADA
US
KOREA
Marketing IVIG, Alb.in more than 30 countries
Local leadershipIn Plasma since 1970
2012 Wholesaler in CHINA
2017 Sales Company in US (E)
2015 Toll Manufacturing Servicesto H.Q CANADA
2015 MKT office in India
Dynamic Market Place
Broaden Out PortfolioSourceOptimization
“Each new productout of 1 Liter willincrementallyimprove profit”
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Cost
Profit
KOR Emerging CAD CHN US
Albumin
IVIG
Specialty Products
1.0 Mℓ[Fractionation] 2.7 Mℓ
2016 2020
Profit Fib.
IVIG
Albumin
IVIG,Alb.PCC
1970s~ 2010s 2020s~
Alb. IVIGSpecialty Products
Upgrade
PCC
Fibrinogen
GreenⅧ-U
USChina US
US
IVIGAlb.
16 Products
Plasma R&D Roadmap
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1
Sourcing
3
Commercial
2
Production
CANADAUS CHINAKOREA
IVIGAlbumin
IVIGAlbumin
IVIGBy-Products
1.0M liters/ year
0.3M liters/ year
7 Plasma Centers
Héma Québec&
CanadianBlood Service
8 Plasma Centers
30 by 2020 10 by 2020
IVIGAlbumin
By-Products
1.3M liters/ year
KoreaRed Cross
Integrate Each Local Operation into Global Plasma Business
CHINA
CANADA
Sales
Sourcing
US
KOREA
Global Business via Integrating Key Resources
Plasma Business: STRATEGIC ROADMAP to create compelling integration
Flu Vaccine Business: NEW OPERATIONAL MODEL to drive focus
What’s Next in R&D : SUSTAINABLE INNOVATION poised for long term value
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2
3
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3 PRIORITIES
• Local leadership in seasonal influenza
vaccine
• More than 100 million doses of Green
Cross seasonal influenza vaccine
administered more than 30 countries
over the past 6 years
• Prequalified by WHO for global use
• Leading provider of influenza vaccine
to pooled procurement of PAHO
☞ Geographical Expansion
: Strength in Public: The largest Supplier for PAHO
Step 1) Mitigate Seasonality
PAHO
192011 2012 2013 2014 2015 2016
S/H N/H
Flu Vx Sales Portion
50%
Unit : dose
New Operational Model for Flu Vaccine
• Local leadership in seasonal influenza
vaccine
• More than 100 million doses of Green
Cross seasonal influenza vaccine
administered more than 30 countries
over the past 6 years
• Prequalified by WHO for global use
• Leading provider of influenza vaccine
to pooled procurement of PAHO
☞ Geographical Expansion
: Expansion to US Market with GC FLU™(QIV)
Step 2) Implement Economies of scale
US
KOREA
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Business Expansion with Potential Growth
Influenza Vx
N/H : Local
S/H : PAHO
USStep 1)
Step 2)
Mitigate Seasonality
Implement Economies of scale
• Local leadership in seasonal influenza
vaccine
• More than 100 million doses of Green
Cross seasonal influenza vaccine
administered more than 30 countries
over the past 6 years
• Prequalified by WHO for global use
• Leading provider of influenza vaccine
to pooled procurement of PAHO
☞ Geographical Expansion ‘09 ‘11 ‘13 ‘15 ‘17 ‘19 ‘21
Multi & SingleQuadrIvalent VaccineWHO PQ
High-DoseEgg basedWHO PQ
TIV QIVQIV-HD
Thimerosal reduction
QIV-TR
QIV USUS
Pre-IND (Ph 3)
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Business Expansion with Potential Growth
Plasma Business: STRATEGIC ROADMAP to create compelling integration
Flu Vaccine Business: NEW OPERATIONAL MODEL to drive focus
What’s Next in R&D : SUSTAINABLE INNOVATION poised for long term value
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2
3
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3 PRIORITIES
Maintain commitment to extracting
maximum value from existing products
Sustainable Growth & Global Expansion
Concentrate on developing innovative products that align
with our technical and commercial capabilities
R&D for Next-Generation Therapy
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Poised for Long Term Value
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Pre-Clinical Phase I/II Phase III
Plasma
Vaccine
GC5101BIVIG SN 10%(US)
GC5101FIVIG 5% (US, Child)
GC3110BQIV (multi)
MG1111Varicella Vx
GC3110GQIV (US)
GC5112AFibrinogen
GC5113AAlbumin 25%(CA)
GC3110CQIV (Multi-TR)
GC5111AGreenVIII-U
GC5122AIg-CAP
GC3114AQIV-HD
GC3110DQIV (child)
GC3111ATdap Vx
GC1109Anthrax Vx
GC3104ADTaP Vx
MG1120AVZV(subunit)
GC5121APCC
Pipelines
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Pre-Clinical Phase I/II Phase III
Plasma
Vaccine
GC5101BIVIG SN 10%(US)
GC5101FIVIG 5% (US, Child)
GC3110BQIV (multi)
MG1111Varicella Vx
GC3110GQIV (US)
GC5112AFibrinogen
GC5113AAlbumin 25%(CA)
GC3110CQIV (Multi-TR)
GC5111AGreenVIII-U
GC5122AIg-CAP
GC3114AQIV-HD
GC3110DQIV (child)
GC3111ATdap Vx
GC1109Anthrax Vx
GC3104ADTaP Vx
MG1120AVZV(subunit)
GC5121APCC
Discovery
MG1124AT de-repressor
MG1122AT engager I
MG1126AT engager II
MG1127ANew target
MG1130ANew target
MG9105ANew target
MG9108ANew target
Recombinant & Others
GC1124AHunterase (SC)
MG1113ATFPI mAb
GC9104AADC
MG1121ALAFATE
GC1123AHunterase (ICV)
GC1102BHepabig-gene (CHB)
GC1118AEGFR mAb
MGAH22Her2 mAb
GC1111BHunterase(US)
GC1101GGreenGene F(2000IU)
GC1102Hepabig-gene (LT)
GC1101DGreenGene F(China)
GC1111FHunterase (P3)
Pipelines
Green VIIIGreen Mono
GreenGene FLong-Acting FVIII
TFPI Ab
Plasma Derived FVIII Recombinant Human FVIIIApproved in Korea in 2011Clinical Trial Phase 3 in China
Innovative Approach
Safety, Patients’ Convenience and Future
Dedicated to Hemophilia
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Quest for Innovation in Hematology
rFVIII3~4 per week
Long-Acting2~3 per week
Next Generation1 per week
Innovative Therapy1 per>2 weeks
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Robust FVIII Portfolio
Increasing the FVIII stability
Minimizing the immunogenicity
Similar form as the naïve FVIIIa
PEGylation
Single chain FVIII
D’D3 domain of VWF
PEGylation in the B domain
Demand for Protein design Solution
Cleavable linker between FVIII andD’D3 domain
B-domain can cleave at bleedingcondition by thrombin
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Escaping from FVIII and vWF clearance
Next Generation FVIII Program
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Next Generation FVIII Program Highlights
*** p<0.001
***
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Innovative Hematology Program Highlights
Plasma-Derived Products Recombinant Protein Monoclonal AntibodyWorld 2nd drug for Hunter Syndrome (MPS II)
Recombinant Factor VIII
Ph.1 & Ph2. for
*LT & **CHB
Ph.1 for colorectal
& gastric cancer
*LT : Prevention of HBV recurrence following Transplantation
**CHB : Chronic Hepatitis B (CHB)
Green Eight™(Plasma-derived Factor VIII)
Hepabig™(Plasma-derived Hepatitis B IgG)
GreenGene F ™(Recombinant Factor VIII)
Hunteraseanti-EGFR mAb
Hepabig-Gene
anti-TFPI mAb
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Accumulated technologies and process of rec-Proteins
New Focus Area : Immuno-Oncology
Innovative Platforms in the Field of Immunology & Protein engineering
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Expertise in Innovative Platform
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Ab
CellImmuneCell-LCTM
Autologous T cellPh 3. completed in HCC
ImmuneCell-LCTM
Autologous T cellPh 2~3. other cancers (2013~)
External
MG4101Allogenic NK cell
Ph 1. completed (2013)
MG4101Allogenic NK cell
Ph 2. *HCC
*HCC : Hepatocellular Carcinoma
~2014 2015 2016 2017~
GC1102HBIG-Gene
Ph 2. LT
GC1102HBIG-GenePh 1. CHB
GC1102HBIG-Gene
Ph 1. LT_completed (2014)
GC1118AAnti EGFR Antibody
Ph-1 completed (2015)
GC1118AAnti EGFR Antibody
Ph 1b/2a Colorectal & Gastric Cancer
MGAH22Anti Her2 antibodyPh 3. Breast Cancer
Collaboration with Magrogenics
External
Experienced in Cell & Ab Therapeutics
: Focus on Early Discovery & Partnership
Key SuccessFactors
•Longstanding Capabilities in the Complex Field of
Hematology and Immunology
•Extensive Expertise in Antibody with Innovative
Platform
•Foundation of Existing Cell Therapy Capabilities
Implement a Risk-balanced, Capital-efficient Strategy
•Totally new targets
•Platform Technologies
•Partnership
Strong Competency
Green CrossPD1
PD-L1
TIGIT
CEACAM-1
BTLA
VISTA
HLA-G
New Targets
EGFR
CD3
HER 3
Mesothelin
GPC-3
TIGIT
BCMA
New Targets
How We Approach Immuno-Oncology
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‘Transform’
Invest for long-term value
Simplify the global Portfolio
Reinforce pipeline through
Business Development
Continue to build scale in priority business
Capture margin improvement
AccelerateGrowth
CurrentBusiness
GlobalExpansion
Innovation
WHAT TO EXPECT
Thank you
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