korea's no. 1 radiopharmaceutical company innovation
TRANSCRIPT
1
ADVANCE
CREATION
PIONEER
Korea's No. 1 Radiopharmaceutical Company
Innovation-driven biotechnology company leveraging
technological competence, organizational breadth and
financial stability
www.duchembio.com
CONTENTS
Radiopharmaceutical Characteristics
Domestic and Overseas
Radiopharmaceutical Market
Merged Duchembio Corporation
01
02
03
Duchembio Growth Strategy
Duchembio Business Goals
Appendix
04
05
06
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals
Radiopharmaceuticals and OTC Drugs, What is the Difference?
Radiopharmaceutical Characteristics
3
Radiopharmaceutical Industry
Types of Isotope
Diagnostic: F-18, C-11, Ga-68, Tc-99m
Therapeutic: Lu-177, I-131,
Actinium-255, Ir-192
Can be used with minimal
structural changes to already
existing substances
ex) Glucose (cancer), dopamine
(Parkinson's), amyloid dye
(dementia), etc.
Radio-Isotopes
Drugs
Radiopharmaceutical
s
Characteristics
1. Radioisotope plays a key role (diagnosis/treatment), Drugs
serve as carriers leading to target diseases
2. Differences from over-the-counter drugs due to short half-life
⇒Finished product: Inventory “0” → Nationwide network manufacturing / Raw
material cassette and technology export
⇒ Manufacturing technology: high yield and manufacturing stability →
determination of commercial feasibility
⇒ New drug development: Candidate material + manufacturing technology →
Impossible to develop without securing manufacturing technology
⇒Marketing: Stable supply is the key → Nationwide network / Back-up factory
3. Specialized in Open Innovation due to the existence of various
candidate substances in the industry
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals 4
Domestic and Overseas PET Radiopharmaceutical Market Outlook
Domestic and Overseas Radiopharmaceutical Market
Expected Market Expansion Due to High Growth Potential of Radiopharmaceuticals
Domestic PET Radiopharmaceutical Market
68.8 Bn KRW(2021) → 719.6 Bn KRW (2030)
The total domestic PET market is worth about 700 billion won by 2030.
Alzheimer's disease market is worth about 200 billion won by 2030
The therapeutics and other market will be about 240 billion won in 2030
Global PET Diagnostic Radiopharmaceutical Market
USD 1.3bn(2019) → 32.3 bn(2025)
The global PET diagnostics market will be worth US$ 32.3 bn in 2025
Dementia diagnosis market size of US$ 30 bn (approximately 5 million people)
0
500
3,000
2,500
2,000
1,500
1,000
2019
300
270
600
2025
450
600-700
1,100
USA
Europe
Asi
a
PET Diagnostics Market
30,000
Amyloid
0
500
3,000
2,500
2,000
1,500
1,000
2021
580
2030
600-700
899
2,427
FDG
FP-CIT
Amyloid
6145
1,929
95
PET Diagnosis/Therapeutic Market
(Unit: KRW 100 million) (Unit: USD Million)
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals 5
Current Status of Domestic and Overseas Radiopharmaceutical Market
Expected to rapidly increase with the introduction of new diagnostic and therapeutic drugs
About 100 billion won in market size in 2019 Over 500 billion won in 2025 Over 1.3 trillion won in 2030
- Diagnostic: Parkinson's disease, Alzheimer's dementia, breast cancer, brain tumor, prostate cancer, etc.
- Therapeutic : Endocrine Tumors, Metastatic and Recurrent Prostate Cancer
Amyloid diagnostic radiopharmaceuticals expected to drive rapid growth of the market
The emergence of various new radiopharmaceuticals that can simultaneously perform targeted diagnosis
and targeted treatment for diseases (Theranostics) where OTC drugs cannot be used such as metastatic
cancer
→ The importance of early diagnosis of dementia and national policies for dementia
⇒ Expected the insurance benefits for Alzheimer's disease diagnosis in 2022
→ With the advent of various Alzheimer's disease treatments, essential diagnostic agents for treatment prescription
Domestic and Overseas Radiopharmaceutical Market
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals
ㅋ
New Duchembio, Undisputed Leader in the Radiopharmaceutical Market
Merged Duchembio Corporation
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Representing the domestic radiopharmaceutical market,
A biotech company growing with organizational breadth and financial stability
Korea's highly competitive No. 1 company
Merger synergy bringing about cost reductions and
manufacturing efficiency
- Operating Loss → Realization of Operating Profit
New drugs sales expansion
Stable financing for the development of new drugs and
overseas business collaborations
Expected the supportive parent company on the
development and introduction of innovative new drugs
Geo-Young
New Governance
The Largest Shareholder
Duchembio, the merged
corporation
DuchembioCareCamp
RP Divivison
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals
New Duchembio Overview
7
Company Name Duchembio Co., Ltd.
CEO Jong Woo Kim
Establishment 2003.03.01
No. of employees 89 (after merger)
Capital 13.9 Billion Won
Business areaDevelopment, manufacture, and sales of
radiopharmaceuticals
Main productsFDG, FP-CIT, Vizamyl, F-DOPA
PARTIO
(As of 2021.10.29)
◼ Company overview ◼ Chief Executive Officer
◼ Shareholder Status
MBA at Indiana University
Yonsei University, Business Administration Major
CEO of Iljin Pharmaceutical Co., Ltd.
Current Duchembio CEO
Total outstanding shares: 26,986,813
Geoyoung, Co., Ltd.51.88%
Third Paries 12.98%
Treasury 1.01%
Others, 34.13%
Merged Duchembio Corporation
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals 8
Duchembio’s Core Business -① Alzheimer’s Disease
Duchembio Growth Strategy
To enable removal of beta-amyloid before cognitive decline worsens,
early diagnosis using radiopharmaceuticals is the only solution
One of AD Hallmarks: Beta amyloidThe only Beta amyloid imaging modality:
Radiopharmaceuticals
Even with modern medical technology,
It is difficult to revive injured neurons destroyed in Alzheimer's disease (AD)
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals
ㅋ
[Source: Ministry of Welfare and Health, Feb. 2021]
Radiopharmaceuticals for AD Diagnosis
Prevalence of Dementia in South Korea
Year Ages 60 and Above
Mild Cognitive Impairment (MCI) Alzheimer’s Disease over ages 65 MCI + Alzheimer’s Disease
No. of Patients % No. of Patients % No. of Patients %
2018 10,765,609 2,172,726 20.2% 771,203 7.2% 2,943,929 27.3%
2019 11,320,069 2,290,463 20.2% 816,393 7.2% 3,106,856 27.4%
Product Developer Development Status
Aduhelm(NCT01677572) Biogen US FDA approval (June ‘21)
Donanemab (NCT02008357) Eli Lilly
June 2021: US FDA Breakthrough
Therapy designation
Sep 2021: Application for BLA
accelerated approval
Gantenerumab
(NCT02051608)Roche
Phase 3 clinical trial (Expected
Completion in H2 2022
June 2021: US FDA Breakthrough
Therapy designation
Expected NDA submission in 2022
Lecanemab (NCT03887455) Eisai
June 2021: US FDA Breakthrough
Therapy designation
Oct 2021: Application for BLA
accelerated approval
AD Treatment Development Status
Manufacture of essential companion diagnostic drugs for AD treatment
Biggest beneficiary of the continued therapeutics emergence
Demand to increase the supply of diagnostic radiopharmaceuticals
No. 1 Manufacturer in Korea
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Duchembio’s Core Business -① Alzheimer’s Disease
Duchembio Growth Strategy
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals
Duchembio’s Core Business -② Radiopharmaceuticals for Cancer Diagnosis & Treatment
Duchembio’s Drug Development Model
for Cancer Diagnosis/Treatment
Business Risks Business Advantages
• Limited scalability of radiopharmaceuticals due to half-life constraints
• High risk, high return of cancer diagnosis/treatment drug development
- Very high cost and long development period vs. low success rate
Focus on Securing ‘Company Stability’ and Profitability
New Drug Development Strategies Tailored for Growth
Competitive advantage in target diseases / market preoccupation
Step Step 1: Build the Foundation Step2: Open InnovationStep 3: Global Development &
Collaboration
ChallengeEstablishment of radiopharmaceutical
infrastructure and network
Securing domestic and global networks
for new drug development, conduct of clinical trials
and new drug registration
Korea's No. 1 radiopharmaceutical company
Leaping to Asia's Leading Company
New Drug
DevelopmentFDG (generic)
FP-CIT, F-DOPA, Neuraceq, Vizamyl,
FACBC, Tau tracer, PSMAConfidential
Outcome/Outlook
• Securing the largest number of
radiopharmaceutical RP centers in Korea
• Promote joint development and
cooperation with leading domestic hospitals
• F-DOPA: Patented neutralization technology
• FP-CIT: Korea's first overseas export RP business
• Neuraceq: Korea's first PET drug registered for AD
diagnosis
• Successful entrance to the Philippines and
accelerating overseas expansion
• Soaring to a company specializing in Alzheimer’s
disease
• Escalating to Theranostics specialty
• Diagnosis of cancer using advanced molecular imaging technology
→ Companion drugs disease treatment & therapy
• Targeted treatment for intractable cancers (e.g. metastatic cancer)
10
Duchembio Growth Strategy
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals
Duchembio’s Core Business -③ Expansion to Overseas Markets
Negotiating overseas export
(USA, EU, Australia, China, Japan)
FES
New Zealand
Australia
Hongkong, China,
Macau
Negotiating overseas export
(Europe, Japan, other Southeast Asia/Latin
America)
F-DOPA(Diagnosis of Brain Tumor etc.)FP-CIT
New drug development
collaboration with
multinational companiesEntry to Japan, China etc.
EU / US
Market
ASIA Market
Entrance
Uzbekistan
(Planning)
Philippines
11
Duchembio Growth Strategy
2017.06 Signed the world's first FP-CIT overseas
export agreement with Cyclotek(Australia, New Zealand)
2019.12 China DC/AMS overseas export licensing
agreement
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals 12
Duchembio’s Core Business Results
Product Commercialization Indication Features
FDG 2010.10
FDG, a glucose analog aids in diagnosis of all tumors that
metabolize glucose (tumor cells are metabolized and grow faster
than normal cells)
Cost reduction basis for radiopharmaceutical companies with
high fixed costs
→ Ranked first in sales in Korea and achieved the lowest cost
in Korea
FP-CIT 2012.03
Diagnosis of Parkinson's Disease by measuring the density of
dopamine transporters in the striatum of the brain
→ The world’s 1st F18 imaging technology for Parkinson’s
Disease and related brain functions
The 1st radiopharmaceuticals to diagnose Parkinson's disease
in Korea
FP-CIT technology patent and clinical data rights sor overseas
export
Neuraceq 2015.05Diagnosis of Alzheimer's disease by measuring the distribution
and density of beta-amyloid in the brain
The 1st Radiopharmaceuticals in Asia for diagnosis of beta-
amyloid plaques in dementia patients
VIZAMYL 2016.02PET imaging of the brain to estimate β-amyloid neuritic plaque
density in adult patients
The only beta-amyloid imaging agent with FDA approval for
color image interpretation
F-DOPA 2019.12
Diagnosis of tumors that cannot be diagnosed with conventional
FDG, mainly brain tumors and additionally neuroendocrine
tumors, pheochromocytoma
The World’s 1st Patented Neutralization Technology
No. 1 in Korea with Distinguished Product Portfolio
1. Undisputed No.1 Position in Korea after the merger of the top 2 players in the market
2. High growth potential as the leading company in the dementia market
3. Having the widest product portfolio and high marketability in the region
4. Most active collaboration projects with multinational pharmaceutical companies (4 projects in total)
5. Possessing the largest number of overseas export items among domestic companies
Duchembio Growth Strategy
Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals 13
Duchembio’s Business and Vision
The Global Company Targeting the Diagnosis and Treatment of Complex Diseases & Neurological Disorders
Future-Oriented Biotechnology Company Growing Globally with Stability and Profitability
Development of intractable cancers/ neurological disease, diagnosis and treatment
Alzheimer's Disease market, model creation and leading entry
Domestic and international development, diagnosis and therapeutic radiopharmaceuticals
Overseas development, domestic manufacturing of therapeutic radiopharmaceuticals
Expansion of technical support projects for Asian countries (Philippines, Uzbekistan, etc.)
Major Business
Platform into the
Asian market
Global Market
Entrance
Duchembio Business Goals
14
Thank you
Provider of next-generation diagnostic and therapeutic radiopharmaceuticals for oncology and neurology