Investor Relatio ns 2020

2

Key Characteristics of COVID-19 COVID-19 is so quickly and sustainably spread through P2P without knowing how and who to be infectious

Source: https://www.cdc.gov/coronavirus/2019-ncov/index.html , / Kinetics of Severe Acute Respiratory Syndrome (SARS)Coronavirus-Specific Antibodies in 271 Laboratory-Confirmed Cases of SARSCLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, July 2004

Speedy &Sustainable

Spread

Community Spread

Community spread means people

have been infected with the virus

in an area, including those who

are not sure how or where they

became infected.

COVID-19 seems to be spreading easily

and sustainably in the person-to person

manners.

Asympto-matic

Infection

Usually people are thought to be most

contagious when they are

symptomatic. But COVID-19 has

shown it is spread from patients

without or very mere symptoms

Complicate symptom & Sample quality *

The most prominent symptom of COVID 19,

the dry cough makes it hard to get the

qualified sample. From the asymptomatic

patient the upper respiratory tract sample

such as nasopharyngeal swap/aspirate

shows only 30% sensitivity at the initial

stage of illness(4 days) and 68% at date 14

with RT-PCR test.

COVID-19 (coronavirus disease 2019), the disease by virus named as “SARS-CoV-2”

3

Limit of virus detecting testsFor asymptotic patients and long & mere symptom patients, the RT-PCR detection capability can be limited

From the asymptomatic

patient the upper

respiratory tract sample

such as

nasopharyngeal

swap/aspirate shows

only 30% sensitivity at

the initial stage of

illness(4 days) and 68%

at date 14 with RT-PCR

test.

Profiling Early Humoral Response to Diagnose

Novel Coronavirus Disease (COVID-19)

Source: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa310/5810754

4

Strong Complementary Serological test The previous MERS and SARS cases has well shown the strong capability of serology test

Antigens

IgM antibodies

IgG antibodies

Antigens

IgG antibodies

Primary infection Secondary infection

Source : http://www.nhc.gov.cn/yzygj/s7652m/202003/a31191442e29474b98bfed5579d5af95.shtml

https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html

China National Health and Health CommissionThe Guideline on the diagnosis and treatment

of COVID-19 (7th Ed.)

IgM antibody can be detected about 3-5 days after the onset of COVID-19

The titer(concentration) of IgG is much higher in the recovery period e.g. 4 times higher

The serology test can be the main for diagnosis. E.g. If the patient has positive in Covid-19 specific IgM, IgG or both, the patient is confirmed as Covid19 patients

US CDC Tests for COVID-19

….The serology test will look for the presence of antibodies, which

are specific proteins made in response to infections. Antibodies

can be found in the blood and in other tissues of those who are

tested after infection. The antibodies detected by this test indicate

that a person had an immune response to SARS-CoV-2, whether

symptoms developed from infection or the infection was

asymptomatic. Antibody test results are important in detecting

infections with few or no symptoms…..

5

Combined Diagnosis is the Key for COVID-19 Diagnosis the complementary power is so prominent in the small scale pre-published data for COVID-19 diagnosis

Source: Antibody responses in COVID-19 patients https://doi.org/10.1101/2020.03.02.20030189

Serology Test Capability cannot be underestimated

6

POCTLab test

Diagnosis of COVID-19 For the tricky COVID-19, two different kinds of diagnosis are definitely needed

Virus Diagnosis : detection of virus

Serology test : detection of antibodies specific to the targeted virus

rt-PCR (polymerase chain reaction) Antigen rapid test)

Antibody (IgM/IgG) rapid test (LFA)

POCT Lab test

ELISA, High-throuput ELISA

OR

7

SGTi-flex COVID-19 IgM and IgG test

CE-IVD KMFDS license

US FDA listed Brazil ANVISA

3월 4월 5월

Weekly Capa.

50 thousand test

1 mil. tests

2 mil. tests

RUSSIA permanent license PERU certified

8

Clinical Evaluation of SGTi-flex COVID-19 IgM/IgG test

Clinical Evaluation (1) Performance tests in many clinical sites

• Three national labs assigned by central government of Spain

- National Center for Microbiology

- Instituto de Salud Carlos III

- Spanish Reference Laboratory of Respiratory Viruses

• ‘P’ Institute in France

• LMZ Dr. Risch Group, the biggest lab groups in Switzerland

• AHP (Paris University Hospitals Organization)

• Greece national lab

Clinical Evaluation (2)

9

SGTi-flex COVID19 IgM/IgG sales

In April

2 mil. tests manufactured

1 mil. tests released

From May

Started manufacturing 2 mil. tests every week

Raw materials for 20 mil. tests secured

10

SUGENTECH’s diagnostics platforms and items

to Home test

to POCT

Allergy

AutoimmuneTuberculosis

Chronic

disease

Female

Hormones

Pregnancy / Ovulation

(digital)

Lab test

Clinic

Home test

General hospitals / Test centers

28,000 in US

Small hospitals / Clinics

220,000 in US

Families

110mil in US

on Sales (red ocean)

about to launch (blue ocean)

in development (blue ocean)

Alzheimer’s

Disease

Periodontal

disease

COVID-19

Flu,

Heart disease

11

Killer Item 1. Blood TB test kitLesson from the COVID-19

• WHO Top 3 infectious

disease

• active TB suspicious

patients: 130 mil / year

• active TB Incidences:

10 mil / year

• 1.6 mil. died of TB annually

• 4th gold standard (with smear,

culture, PCR)

• TDM (Therapeutic Drug

Monitoring)

• Annual test for the olds (over

65 years)

Latent TB

patients

1.7 billion(22% of world pop.)

10%

Annual

active TB

Incidence

10 millionin global

CLINIC test

(POCT)

Lab test

?? X

12

Killer Item 1. Blood TB test kitcurrent TB tests with sputum

chest X-ray

Sputum

collection

Suspicious

patient

Smear microscopy

PCR

~ 4 weeks

~ 1 day

Culture test

Positive

70%

Negative

30%

Culture-negative

TB

Active TB

diagnostics market

USD 2 bil / year~ 1 day

In China

Culture-negative

TB ratio

70%

13

thenand

10μL

Serum

Mix the reaction solutions.

Then Into the sample well of the cassette.

After 20 minutes of reaction, confirm the result.

Reconstitute the 2nd reaction

buffer using Rxn Buf Prep.

Power and Solution

Add a sample to the

pretreatment buffer

incubate for 20 minutes

INCLIX™ Blood TB test kit INCLIX™ analyzer

Test Procedure

Products

Killer Item 1. Blood TB test kitINCLIX™ Blood TB, TB rapid test kit with blood

14

Gold Standard

INCLIX™ Blood TB Business PlanKiller Item 1. Blood TB test kit

Novel POCT solution for

active TB

• Approved by K-MFDS in 2019, Launched in 2020 (delayed due to COVID-19)

• EU CE certified in 2019, Several EU distributors are testing

• Clinical study with 1600 patients will be started soon in China (with Fudan Univ.)

• On clinical study in Malaysia and Thailand

• Clinical study design with FIND

PCR

• Lab test

• Need for

expensive

instrument

POCTizatio

n

TB test

with sputum

Culture

Smear microscopy

• Lab test

• ~4 weeks

• High cost

• Lab test

• Low

accuracy

POCTization

Culture-

negative

TB

Sales $ 538m in 2015

6.9 mil. test purchased by WHO (2017)

Acquired by Danaher at $ 4.0 bil. (2016)

GeneXpert story

Novel POCT solution

for active TB

15

Killer Item 1. Blood TB test kitPOCTization of TB diagnostics

POCT 化

Lab test

Clinic

POCTization of TB diagnostics

• TB diagnostics in Clinics

• Therapeutic Drug Monitoring

• Annual diagnostics in schools

• Annual diagnostics of the olds (over

65)

General hospitals / Test centers

28,000 in US

Small hospitals / Clinics

220,000 in US

16

Killer Item 1. Blood TB test kit

* Latent TB test market: 50 mil. Test / year* IGRA, Interferon-Gamma Release Assay

TB diagnostic kit companies

Xpert MTB/RIF INCLIX Blood TB Quantiferon-TB T-SPOT TB

For active TB active TB latent TB latent TB

Principle rt-PCR, Immunoassay IGRA, ELISA IGRA, ELISA

Sample Sputum Blood Blood Blood

Time 2 hours ~ 20 minutes 20 hours (manual) 20 hours (manual)

Sensitivity /

Specificity74~96% / 99% 85% / 93% 92% / 99% over 95%

Strong pointsMTB/RIF available,

Automation

No sputum collection, rapid,

convenient, economic,

detection of culture-negative

TB

130+ countries accepted Latent

TB testconvenient

Weak points

Expensive instrument, high

cost, sputum collection (hard

sampling, contamination)

Need for clinical study with

various patients

Time consuming,

not for active TB

Time consuming,

not for active TB

Sales

$ 538m (FY2015)

6.9 mil. tests purchased by

WHO (2017)

- $223 m (FY2018) $54 m (FY2018)

Developer Cepheid Sugentech Qiagen Oxford Immunotec

Developer’s

Mkt cap.

$ 4.0 b

(M&A value)

$ 230 m

(KOSDAQ)

$ 9.1 b

(NYSE)

$ 252 m

(NASDAQ)

17

for

LG Chemicals

Full-auto instrument

Semi-auto instrument

Reader Blotting instrument

Reader

Instruments

ODM businessInstruments for our own test kits

& Allergy test kits

for

LG Chemicals,

YHLO (China)

for

Proteomtech,

BIOCUP (China)

Killer Item 2. Multiplex Allergy Test

• Global No.1 is Euroimmun (acquired by Perkin Elmer)

• CS for instruments is key competing factor (the only

maker of instruments & kits)

• Will be launched in Korea, Asia, Latin America in 2020

• China distributorship with YHLO will be launched in 2021

Allergy test kits for 100+ allergens

Global $ 6 bil.

Asia (except for China) $ 600 mil.

China $ 500 mil.

Korea $ 20 mil.

Full-auto instrument

Semi-auto instrument

18

Killer Item 3. Mobile testerfor Female Hormones

Digital pregnancy / ovulation

tester (disposable)Mira Fertility Tracker Surearly Smart

Developer SPD, C&D, SUGENTECH Quanovate Tech SUGENTECH

Test For Pregnancy, Ovulation Ovulation

Symptoms with female hormones

(ovulation cycle, pregnants’ risk,

menopause)

Appicable to -Vitamin, Influenza,

Allergy home testing

Personalized healthcare service,

Prescription based home testing for

chronic diseases

Healthcare service under development by Modori-C (affiliate of SUGENTECH)

CE-IVD and K-MFDS certification will be done in 2020 and launch in Korea and global

Join Venture business in China (manufacturing, distributing and healthcare

service operation) under negotiation

Business collaboration with various consumer companies under negotiation

19

Killer Item 3. Mobile testerBusiness plan

Home test

Pregnancy

Clinic

Home test

Lab test

Medical bigdata

Personalized healthcare service

Ovulation

cycle

Pregnants’

risk

Chronic

diseases

Skin care

Diet

Visit doctor

28,000 in US 220,000 in US

110mil in US

Diabetes

complications

Menopause