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
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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
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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
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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%
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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
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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