korea's no. 1 radiopharmaceutical company innovation

14
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

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Page 1: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 2: Korea's No. 1 Radiopharmaceutical Company Innovation

CONTENTS

Radiopharmaceutical Characteristics

Domestic and Overseas

Radiopharmaceutical Market

Merged Duchembio Corporation

01

02

03

Duchembio Growth Strategy

Duchembio Business Goals

Appendix

04

05

06

Page 3: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 4: Korea's No. 1 Radiopharmaceutical Company Innovation

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)

Page 5: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 6: Korea's No. 1 Radiopharmaceutical Company Innovation

Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals

New Duchembio, Undisputed Leader in the Radiopharmaceutical Market

Merged Duchembio Corporation

6

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

Page 7: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 8: Korea's No. 1 Radiopharmaceutical Company Innovation

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)

Page 9: Korea's No. 1 Radiopharmaceutical Company Innovation

Duchembio, Co., Ltd. l Provider of next-generation diagnostic and therapeutic radiopharmaceuticals

[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

9

Duchembio’s Core Business -① Alzheimer’s Disease

Duchembio Growth Strategy

Page 10: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 11: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 12: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 13: Korea's No. 1 Radiopharmaceutical Company Innovation

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

Page 14: Korea's No. 1 Radiopharmaceutical Company Innovation

14

Thank you

Provider of next-generation diagnostic and therapeutic radiopharmaceuticals for oncology and neurology