1. Bioneer MDx Technology
BIONEER IR
Bioneer MDx Technology
This material is prepared for the purpose of understanding BIONEER and its main business areas. Therefore, BIONEER is not responsible for investment decisions etc. made based on this material. Also, it is prohibited to use, post and/or distribute part or all of this material without the expressed consent of BIONEER.
Corporate Overview
Copyright , Bioneer Corporation. All rights reserved.

2. Intellectual Property
Company Overview
Company Overview
History
Intellectual Property

3. Market Capitalization
BIONEER IR
Bioneer Overview (KOSDAQ )
Han-Oh Park, President & CEO
Location
Daejeon, South Korea
KOSDAQ Listed
/Established /
Key Products
MDx Instruments and Kits,
Oligos and Research Products,
siRNA Drug Development
Employees
317 (as of )
Market Capitalization
198 Billion(KRW) (as of )
Webpage
Ph.D. Biochemistry, KAIST
B.S. Chemistry, Seoul National University
Vice President, Korea Biotechnology Industry Organization
Director, Korean Institute of Genetic Testing Evaluation
Adjunct Professor, KAIST Biosystems Department
Adjunct Professor, Seogang University
Committee Member, Presidential Advisory Council on Science & Technology (2011, )
Committee Member, Evaluation Expert Committee,
National Science & Technology Commission ( )
R&D
Global Bioneer
35% of the entire employees are in R&D
Strong IP Portfolio with 450 global IPs
Korea, U.S., China, Australia, and 60 countries
Headquarters
Pangyo R&D
Cheongwon Factory
Alameda, U.S.

4. BIONEER’s Roadmap From Genomic Technology to the Health Care Industry
BIONEER IR
BIONEER’s Roadmap
Molecular Diagnostics
From Genomic Technology
to the Health Care Industry
Reagent kits
(Research and MDx)
MDx Instruments
(Prep / qPCR)
Gene Synthesis
GPScreen™
Genome-wide Toxicity Profiling technology
Enzymes/
Reagents
(Molecular
Biology)
DNA/RNA
Synthesis
SAMiRNA™ RNAi-based Platform technology
New Drugs
Pre-clinical
(Animal) Trials
System
Development
For Genomics
Magnetic Particles
for Biologic Processing
Anti-obesity treatment
development
Nano-Bio
Functional Foods

5. From Korean Biotech Founder To Global Leader
BIONEER IR
History
From Korean Biotech Founder To Global Leader
Start-up : 1992 ~ 1999
Growth : 2000 ~ 2007
Expansion : 2008 ~
′92.08
Est. Korea Biotech Inc.
(1st KRIBB spin-off)
′92.09
First in Korea to develop and supply enzymes and primers for PCR
′95.06
Elected as the 1st Tech Development Excellence Company
′95.07
First in Korea to develop PCR instrument
′96.07
Renamed BIONEER Corporation
′97.05
Assigned Promising High-Tech Company
′97.06
Charter member of Venture Business Association
′98.12
ISO9001 Certification
′99.01
U.S. Patent for room-temperature stable - AccuPower® PCR technology
Awarded Gold Prize in Korean Patent Technology Contest
′00.05
World-first development of automatic 384-well DNA synthesizer
′00.12
Awarded the 1st Biotech Industry Award
′01.07
Awarded Minister′s Award for MKE Korean Technology Contest
′01.09
Completion of world’s largest capacity DNA synthesis center
′02.05
Development and deployment of Bio-terror agent detection real-time PCR instrument (first in Asia)
′02.10
Awarded the Presidential Award for Venture Business
′03.03
Selected as 2nd in Biotech sector for DTT Asia Pacific Technology
FAST 500
’04.06
Recognition, Korean World-class Product Award DNA Synthesis
(Minister of Knowledge Economy)
′04.08
INNO-BIZ Certified
′05.10
Awarded $1 million export prize
′05.12
IPO (KOSDAQ)
′06.11
Awarded $3 million export prize
′08.01
ISO 13485:2003 Certification
′08.12
Awarded MKE Minister’s Prize for Korean Technology Awards - Exicycler™
′09.05
Certification of Korean GMP for Korean IVDD manufacturing and quality management standard conformity
′09.08
Supplying of pandemic H1N1 diagnostic system
′10.04
Appointed cutting-edge technology business within Daedeok Innopolis
′11.12
Recognition, Korean World-class Product Award ExiProgen™, ExiStation™
(Minister of Knowledge Economy)
′12.01
Filing patent application on Dual HotStart
′12.04
Research Collaboration Agreement with Sanofi for Liver cancer drug
′12.06
Certification, Innovative Pharmaceutical Company (Minister of Korea Health Industry Development Institute)
′12.11
First prize, 4th Intellectual Property Management Award (Minister of Knowledge Economy)
US, EU Patent registration of Lb.Gasseri BNR17
′13.01
Korea Patent registration of SAMiRNA™ Technology
′13.12
Awarded $5 million export prize
′14.07
U.S. Patent registration of SAMiRNA™ Technology
′14.11
Certification, Functional Indredient for Health/Functional Food of Lb.Gasseri BNR17
′15.06
Research Collaboration Agreement with Yuhan Corp. for Anticancer
′15.07
Japan, China Patent registration of SAMiRNA™ Technology
′15.09
Licensing-Out Agreement with Yuhan Corp .
- 3 target SAMiRNA drug candidates
Present
Authorization of IVD instrument(4 items), IVD reagent(42 items) and IVD Nucleic acid extraction reagent(20 items) from MFDS

6. Trademarks Registered Oligo DNA/RNA synthesis
BIONEER IR
Intellectual Property
Patents
Registered
Applied
Trademarks Registered
Trademarks Applied
Programs Registered
Design
Total
Korea
129 34 33 4 3 1
204
Overseas 89
185 19 -
296
218
219 52 7
500
Technology product
Related major patent
Korea
Overseas
Application
Registration
Oligo DNA/RNA synthesis  
Dried oligonucleotide composition and method of producing the same (Registration No ) etc.   2 4 5
Drug discovery
siRNA conjugate and preparing method thereof (Registration No ) Method for screening of drug using systematic deletion mutant of fission yeast (Registration No ) etc. 10 16 56 18
Functional
microorganism
Lactic acid Bacteria Isolated From Mother's Milk with Probiotic Activity and Inhibitory Activity Against Body Weight Augmentation (Registration No ) etc.   - 1 15
Molecular
diagnostics
Dried Composition for hot-start PCR with Long-Term Stability (Registration No ) Lyophilized reagent for polymerase chain reaction (Registration No ) etc.   6 52 23 17
Gene analysis
system
Real-time PCR monitoring apparatus (Registration No ) The automatic purification apparatus, multi well plate kit and isolation method of nucleic acid from biological samples (Registration No ) etc. 9 20 69 28
Nano technology
Nanoporous Films and Method of Manufacturing Nanoporous Films (Registration No ) etc.   7 14 3
Biodefense & others 
Air collecting device (Registration No ) Automatic Water Toxicity Measuring Apparatus (Registration No ) Method for Identifying Vehicle and Oligonucleotide Marker Used Therefor (Registration No ) etc. 19

7. Introduction
Bioneer`s Powerful Technology for MDx

8. in the Global Molecular Diagnostics Market
BIONEER IR
Bioneer’s edge
in the Global Molecular Diagnostics Market
Bioneer’s platform technologies
Bioneer provides ExiPrep™ the compact and competitive automated nucleic acid extractor(various kits) and Exicycler™ 96, the first real-time PCR instrument in Asia(2003) with completely uniform optical across all 96 wells.
Bioneer has next generation technology for PCR and RT-PCR reactions allowing ultrasensitive MDx.
Bioneer’s AccuPower® Premix is most stable and user-convenient MDx kits.
Bioneer provides unique platforms : ExiStation™, a semi-automated pipetting-free real-time qPCR MDx system

9. ExiPrep™16 Dx Fully Automated Nucleic Acid Extraction System
BIONEER IR
ExiPrep™16 Dx Fully Automated Nucleic Acid Extraction System
FDA, CE, MFDS certified
Automated nucleic acid extraction
Proprietary nanomagnetic silica bead
Extraction of DNA or RNA from 1 to 16 samples at once with specific kits
Each prep kits contain all of the plastic consumables and buffers pre-loaded in cartridge
Prevention of cross-contamination: Contamination shield protects from the aerosol and droplet
Automatic Reaction prep :
Precise Pipetting for optimum reproducibility
Cooling Block : store fresh reaction mixture
Protection cover remove aerosol contamination
Designed by the priority of Safety:
Close system: No air flow inside/outside
Built-in heating block for sample lysis inside the instrument
Automatic sterilization by UV lamp
ExiPrep™16 Dx

10. Exicycler™ 96 Real-Time Quantitative Thermal Block
BIONEER IR
Exicycler™ 96 Real-Time Quantitative Thermal Block
CE, MFDS certified
Uniform Illumination with LT(Light Tunnel) Technology
Real 5-Color Multiplex detection
Real-time Analysis
Fast and Accurate Analysis
Use Various Fluorescent Dyes
Wide Linear Dynamic Range
Intuitive and Convenient Software
Exicycler™ 96

11. AccuPower® Technology
Outstanding reproducibility
Large-scale batch production through automated processes and minimized user error (one-step pipetting) means consistent results run after run.
Signature convenience
All components for the assay are contained within the tube. Just add sample!
Industry-leading stability
Lyophilization suspends reagent deterioration, leading to longest-in-class more than1 year shelf-life.
BIONEER
competitors
Company
BIONEER
R Company
Convenience
+++
(Lyophilized) ++
(Frozen liquid type; requires mixing)
Stability
(Over 1 year in freezer)
(Less than 6 months in freezer)
Cross-contamination resistance
Automation
(Simple process and instrumentation) +

12. RocketScript™ RTase RocketScript™ RTase Competitor’s RTase
Native M-MLV
Activity at 42℃
2nd structure RNA
~ low sensitivity at cDNA synthesis
cDNA synthesis
By active enzyme
Tem. ↑ up to 70℃
RNA denaturation
Competitor’s RTase
Fail of cDNA synthesis
By denaturation
RocketScript™ can maintain its activity up to 70℃.
- Better performance, especially for complex 2nd structure RNA molecules
- Excels in long-target RT single gene-multi target assays

13. Conventional HotStart
Dual-HotStart™ Technology
Conventional HotStart
Dual-HotStart™
Target
Non-specific bands
106`
105`
104
103
102
101
- Concentration +
Accurate data analysis is impossible due to weak signals
106`
105`
104
103
102
101
- Concentration +
Ultra-sensitivity MDx technology from Bioneer enables to detect a few copies of RNA by removing nonspecific cDNA amplification.

14. ExiStation™ Manager s/w
BIONEER IR
ExiStation™ Universal Molecular Diagnostics System (1)
ExiStation™ is an automated real-time PCR-based molecular diagnostic system. This system contains three ExiPrep™16 Dx nucleic acids extraction instruments and one Exicycler™ 96 real-time quantitative thermocycler, which allows up to 48 individual clinical specimens per run. ExiStation™ is a pipetting-free system from nucleic acid extraction to nucleic acid amplification, providing increased convenience, practicality and reproducibility.
Simultaneous test of 3 different assays
Various types of clinical samples
Simultaneous detection of up to 8 pathogens from a single prep with a probe- based multiplex Real-time PCR technology
Random Access
Quantitative, qualitative assay
Quantitative, qualitative assay
Multiplex
Pipetting Free!
Extracts are directly dispensed into the PCR premix tubes.
2 hrs
Extracted DNA or RNA
1.5 hrs
Clinical sample
ExiPrep™16 Dx
Initial time-to-result: ≤3.5 hours
Exicycler™96
AccuPower® MDx Kit
ExiStation™ Manager s/w

15. Save results and update DB
BIONEER IR
ExiStation™ Universal Molecular Diagnostics System (2)
World’s unique MDx platform able to handle various types of samples simultaneously
ExiPrep™ 16 Dx
Simultaneous extraction of DNA/RNA from various types of clinical samples with 3 instruments at once
Plasma
Sputum
Urine
Exicycler™ 96
Sample Prep
ExiSpin™
Simultaneous test for different targets in a single run
Simultaneous test is possible for DNA and RNA targets
Simultaneous test is possible for quantitative and qualitative assay
Diagnostic software, automatic result analysis
Analysis
Diagnostic Kits
Continuous workflow from sample to result,
within the shortest time
3.5 hours for 48 tests
Save results and update DB

16. AccuPower® Diagnostic Kits
BIONEER IR
AccuPower® Diagnostic Kits
Pathogen Detection
Hepatitis
Hepatitis B virus (HBV)
Hepatitis C virus (HCV)
Tuberculosis
- Mycobacterium tuberculosis (MTB),
Non-tuberculous Mycobacteria (NTM)
Multidrug-resistant tuberculosis (TB & MDR)
Respiratory pathogens
- Influenza A
New Influenza A (H1N1-2009)
Pneumonia pathogens
- Chlamydia pneumomiae
Mycoplasma pneumomiae
Sexually transmitted infections
- Chlamydia tracomatis (CT)
- Neisseria gonorrhoeae (NG)
Ureaplasma urealyticum (UU)
Mycoplasma genitalium (MG)
Trichomonas vaginalis (TV)
Mycoplasma hominis (MH)
Herpes simplex virus type 1,2 (HSV1,2)
Transplantation screening
- Cytomegalovirus (CMV)
- Epstein-Barr virus (EBV)
BK virus (BKV)
Gastrointestinal pathogens
Enterovirus
Enterovirus 71 (EV71)
Norovirus
Foot-and-mouth disease
Foot-and-mouth disease virus(FMDV)
Genotyping
Warfarin metabolism
Wafarin genotyping
(VKORC1 & CYP2C9)
Clopidogrel metabolism
CYP2C19 genotyping
Ankylosing spondylitis
- HLA-B27 Real-Time PCR
Alzheimer’s Disease
- ApoE genotyping
Mercaptopurine/ Azathioprine/
Thioguanine metabolism
- TPMT genotyping
Myeloproliferative disorder
- JAK2 V617F Quantitative
Hyperhomocysteinemia
- MTHFR Genotyping
Thrombophilia
- Factor V Leiden Genotyping

17. MDx Platform Pipeline: ExiStation™ HT
BIONEER IR
MDx Platform Pipeline: ExiStation™ HT
HIGH-THROUGHPUT FULLY AUTOMATED SYSTEM
ExiStation™ HT :
Filling the gap in fully automated MDx
Sample preparation
Amplification
& Detection
Sample supply
True sample-in, data-out automation
Up to 1,800 targets from 450 samples with one load
Up to 5,400 targets with 3 full runs
Blood bank screening & General health check-up screening
Diagnosis
Blood screening, infectious diseases such as Hepatitis B and C, HIV, Tuberculosis, CT, NG, and respiratory pathogens
For large hospitals and clinical testing centers
thousands of tests/ day

18. Company’s Growth Strategy
BIONEER IR
Company’s Growth Strategy
Next-generation businesses supported
by mainstream business & core competence
to become an integrated global healthcare company
Phase 1
Phase 2
Phase 3
1992 ~ 2005
2006 ~ 2015
2016 ~
Foundational R&D
Establish Core Competence
Global Company
Setup a research products line based on DNA/RNA synthesis & Molecular biology products
Next generation qPCR MDx Platform : Ultrasentive MDx technology, ExiStation™, ExiStation™ HT, Exicycler™ HD
SAMiRNA™ therapeutics platform
Maximize synergy as a Molecular Diagnostics & Therapeutics company

19. BIONEER IR
Thank you