39th Annual J.P. Morgan Healthcare Conference
Se Chang Kwon President & CEO
Hanmi Pharmaceutical Co., Ltd.
1
This presentat ion contains forward-looking statements with respect to future f inancial
condi t ion, results of operat ions and businesses of Hanmi Pharmaceut ical Company.
By their nature, forward-looking statements and forecasts involve risk and uncertainties
because they relate to events and circumstances that wi l l occur in the future. There
are a number of factors that could cause actual resul ts and developments to di ffer
material ly from those expressed in or impl ied by the forward-looking information and
s ta tements . These r i sks and uncer ta in t ies inc lude, among o ther th ings , the loss
or expiration of patents, marketing exclusivity or trade marks; exchange rate fluctuations;
t he r i sk tha t R&D wi l l no t y ie ld new produc ts tha t ach ieve commerc ia l success ;
t h e i m p a c t o f c o m p e t i t i o n , p r i c e c o n t r o l s a n d p r i c e r e d u c t i o n s ; t a xa t i o n r i s k s ;
the risk of substantial product liabil ity claims; the impact of any failure by third parties
t o supp l y ma te r i a l s o r se rv i ces ; the r i s k o f de lay t o new produc t launc hes ; the
diff icult ies of obtaining and maintaining governmental approvals for products; the risk
of fai lure to observe ongoing regulatory oversight; the risk that new products do not
per fo rm as we expec t ; and the r i sk o f env i ronmenta l l i ab i l i t i es . Hanmi does no t
undertake any obligation to update or revise any forward-looking information or statements.
2
Who We Are
(Automated Drug Packaging System Company)
3
• 6 R&D Centers
• LAPSCOVERY Platform (Biologics)
• 3 Manufacturing sites
• Sales and Marketing
• Manufacturing
• PENTAMBODY Platform (BsAb)
Our Businesses
Strong Strategic Alliances around the Globe
“We value our partners and our innovation”
Bioplant Fine Chemical Paltan
Biologics
•RNA/DNA
•Protein
APIs
•Nucleotide
•Peptide
•PEG
Finished Product
•Oral Dosage
4
COVID-19 Response
Hanmi’s Sustainability in Response to COVID-19 Pandemic
Hanmi is among the top 5 Korean pharmaceutical company
with a market cap3 of $7.06B and revenue of $1.01B (2019)
Sustained Growth during COVID-19 Pandemic6% Growth Rate in 2020 2)
Advances in R&DStrong commitment in R&D supported by investment and 580+ R&D staff
Innovative pipeline expands & late stage clinical studies and registration
Efforts to overcome COVID-19Multi-angle approaches powered by strong internal R&D capacity,
as well as open innovation
8%Growth rate1
19%Of Revenue
Multi-
Solution
1) Consolidated Business Results of 2016~2019 2) Hanmi Pharmaceutical Growth Rate in 1Q~3Q 2020 3) Market capital of Hanmi Pharmaceutical, Hanmi Science, JVM (as of 2020.11.23)
A Pharmaceutical
Powerhouse
in Korea
5
Efforts to overcome COVID-19
Vaccine Therapeutics Diagnostic Kit Medical Device
Next Wave
COVID-19 VaccineNCEs & Biologics
COVID-19/Influenza
Dual DetectionHanmi COLDMASK®
• mRNA platform:
- Develop
mRNA formulation
- Nucleotide optimization
& manufacturing
• Multiple candidates are
under development (Preclinical)
• Evaluating novel targets in
COVID-19 infection:- PIKfyve inhibitor
- Thymosin α1 modulator Distribution of
COVID-19 & Influenza
Dual Test Kits
• Nasal Spray:- preventing
penetration of
respiratory
infections and
protecting mucous
membranes
- Forming a
physical barrier
on nasal mucous
membranes
Multi-angle Approach Against Pandemic
6
GMP production facilities with on-site R&D resources• Hanmi Bio Plant: Biologics Manufacturing and Development
• Hanmi Fine Chemicals: Synthetic Chemical APIs, Nucleotide, Intermediates, Peptides
Hanmi plants for COVID-19 vaccine manufacturing:
Unique mRNA/DNA manufacturing capability which is different from that of conventional vaccine
Best-fit CMO/CDMO facility
from clinical to
commercialization
Hanmi has strength in…• in in-vitro manipulation (e.g. biochemical reactions such as conjugation process)
• fermentation for global supply
Collaboration Opportunities:
Commercial/clinical contract manufacturing for mRNA/DNA bulk
Co-development for process improvement and CoGs reduction
Strategic sourcing of key raw materials
Manufacturing Capabilities Against Pandemic
7
“Manufacturing is the highest priority”
Hanmi Open Innovation: Focused Area
Strive to access external talents and resources
Immuno
-Oncology
New Modality
PlatformCNS & Rare
Disease
Inflammation &
Fibrosis
Open
Innovation
First-in-class
AI for drug discovery First-in-class
Undruggable Target Approach
Neuro-inflammation
First-in-class
Co-development collaboration
GC8
FLX475 Rights of
Korea & China (03-DEC-2019)
Combination Therapy :
FLX475 + KEYTRUDA
KEYTRUDA Supply (15-SEP-2020)
RAPT
TME inhibitors(DisC, PreC)
Phanes
Beijing Hanmi
Target Sequence (17-SEP-2019)
Targeting Tumor Immunology
through Internal and External Expertise
Standigm
PD-L1-TAA2)
Bispecific Ab (PreC)
1) Gastric Cancer 2) Tumor Associated Antigen
Research Development &
Collaboration for AI Platform(22-JAN-2020)
•Standigm AI platform (Standigm BEST® )
•AI-based lead optimizationGC1) Ph2 in Korea & China 1Q 2021
Immune Modulating Target
In-house Candidates :
Open to Collaboration
AI-based T cell Target Tumor Microenvironment Target
(CCR4 inhibitor)
9
RESEARCH UPDATE
10
Pre-Clinical Phase 1 Phase 2 Phase 3 / Registration
8Obesity/NASH
Diabetes
HM14320 (LAPSGlucagon Combo)
Obesity/NASH/Diabetes
HM15136 (LAPSGlucagon Analog)
Obesity
Efinopegdutide (LAPSGLP/GCG)
NASH
Efpeglenatide (LAPSExd4 Analog)
Diabetes
HM14220 (LAPSInsulin Combo)
Diabetes
HM12460A / HM12470 (LAPSInsulin)
Diabetes
HM15211 (LAPSTriple Agonist)
NASH
HM12480 (LAPSInsulin148)
Diabetes
12Oncology
HM97662 (EZH1/2 Dual Inhibitor)
Solid tumors / Hematology malignancies
Belvarafenib (Pan-RAF Inhibitor)
Solid tumor
Poziotinib (Pan-HER Inhibitor)
NSCLC & Breast cancer
Rolontis® (Eflapegrastim)
Neutropenia
BH3620 (Undisclosed BsAb)
Targeted immuno-oncology
HM43239 (FLT3 Inhibitor)
AML
Oratecan (Oral Irinotecan + Encequidar)
Solid tumor
Oraxol (Oral Paclitaxel + Encequidar)
Metastatic Breast cancer
BH3120 (PD-L1/4-1BB BsAb)
Solid tumor
IBI315/BH2950 (PD-1/HER2 BsAb)
Targeted immuno-oncology
Oradoxel (Oral Docetaxel + Encequidar)
Solid tumor
FLX475 (CCR4 inhibitor)
Gastric Cancer
5Rare Diseases
3 Others
HM15450 (LAPSASB)
Mucopolysaccharidosis
Luminate® (Integrin inhibitor)
Retinitis Pigmentosa
HM15136 (LAPSGlucagon Analog)
Congenital hyperinsulinism
HM15912 (LAPSGLP-2 Analog)
Short bowel syndrome
Efpegsomatropin (LAPShGH)
GH deficiency
Luminate® (Integrin inhibitor)
Diabetic Macular Edema
HM71224 (BTK Inhibitor)
Autoimmune/Allergic diseases
Oraxol (Oral Paclitaxel + Encequidar)
Angiosarcoma
Under BLA/NDA Review
11
*Phase 2 Planned
*Phase 2 Planned
Inflammation
& Fibrosis
Co-agonists to resolute NASH,
a complex disease with
no approved therapies
Strategic Priorities in R&D
Focusing on Core Therapeutic Areas
“ Creating value through innovation ”
Metabolic
Disease
Novel solutions for OBESITY and
T2DM together with mono and
combination regimens
Oncology
Cancer treatment
through innovative
platforms,
TKIs, Biologics and
Immuno-oncologics
Rare Disease
Technologies to
overcome
rare disease
- Short bowel syndrome
- Congenital Hyperinsulinism
- Lysosomal Storage Diseases
Extensive research
on human incretin analogues to treat
inflammatory and fibrotic disease
12
NASH: LAPSGlucagon/GIP/GLP-1 Triple Agonist (HM15211)
Relative Liver Fat Changes by MRI-PDFF
• Shown compelling outcomes in steatosis resolution
• Higher dosed patients achieved ≥ 50% liver fat reduction
• Rapid and Potent by effective liver targeted action
(↓de novo lipogenesis and ↑b-oxidation)
Rapid and Potent effect
by Liver targeting
Change from Baseline of ALT at Week 12 2
Placebo
Cohort2
Cohort3
Cohort4
Cohort1
Cohort5
2/15 0/9
4/9
6/10
8/9
9/9
Placebo Cohort2 Cohort3Cohort1 Cohort5
100%
50%
0%
-50%
-100%
+24.3
-46.1-30.1
-46.9-83.0
Cohort 1 (N=9) Placebo (N=3)
Cohort 2 (N=9) Placebo (N=3)
Cohort 3 (N=9) Placebo (N=3)
Cohort 4 (N=9) Placebo (N=3)
Cohort 5 (N=9) Placebo (N=3)
Study Design (BMI ≥ 30 kg/m2, Liver fat ≥ 10%)
Study Result 1
Relative Reduction in Liver Fat (%) Patients with ≥ 50% Reduction
Placebo
Cohort2
Cohort3
Cohort4
Cohort1
Cohort5
-5.7
-43.0-44.5
-71.0
-19.6
-81.1
13
• Shown promising anti-fibrotic potential
• Phase 2 Study in biopsy-proven NASH patients (US)
• FDA fast track granted : NASH (Jul. 2020)
• ODD granted : PBC and PSC (Mar. 2020)
Rapid and Potent effect by Liver targeting,
“The right incretin for NASH”
Diet-induced model Chemical-induced model Surgery-induced model
Study
design
Change in
Fibrosis1
CD-HFD (+1.2% cholesterol) AMLN diet +TAA (Thioacetamide) Bile-duct ligation
0 24 weeks
8 weeks
0 16 weeks
8 weeks
0 2 weeks
2 weeks
Matching Placebo
Cohort 1
Total subjects N≈214, 52 weeks
Cohort 2R
Cohort 3
Matching Placebo
Selected Dosage 1
Selected Dosage 2
FU
Biopsy Biopsy
Phase 2b Study DesignBiopsy-confirmed NASH and fibrosis
-5 0 0
-4 0 0
-3 0 0
-2 0 0
-1 0 0
0
H
yd
ro
xy
pr
oli
ne
(n
mo
l/g
liv
er
vs
. A
ML
N/T
AA
Ve
h.)
* * *
-1 2
-1 0
-8
-6
-4
-2
0
S
iriu
s r
ed
po
sit
ive
ar
ea
(%
vs
. C
D-H
FD
Ve
h.)
*
-2 .0
-1 .5
-1 .0
-0 .5
0 .0
F
ibro
sis
sc
ore
(vs
. B
DL
Ve
h.)
* * *
†
■ Triple Agonist 3mg
■ BDL Veh.■ Triple Agonist 2mg
■ BDL Veh.
■ Triple Agonist 2mg
■ BDL Veh.
■ OCA 244 mg/d HED
NASH: Promising New Target for Fibrosis (HM15211)
14Interim Analysis
(2021 4Q)
Inflammation
Score
Inflammation
Score
Fibrosis
Score
0 .0
0 .5
1 .0
1 .5
2 .0
*
* * * * * *
†
0 .0
0 .5
1 .0
1 .5
2 .0
2 .5
* *
* * * * * *
†
Inflammation & Fibrosis: ‘What’s Next’
HM15211’s opportunity in the large unmet medical needs beyond NASH
“ Creating value through indication expansion ”
Nonalcoholic steatohepatitis (NASH)
Primary Biliary Cholangitis (PBC)
Primary Sclerosing Cholangitis (PSC)
PBC & PSC: FDA ODD (Mar 2020)
Liver
FibrosisPulmonary
Fibrosis
□ Normal Vehicle
■ Sham Vehicle
■ BDL Vehicle
■ OCA 30 mg/kg, po, QD (220 mg/day HED)
■ HM15211 71 μg/kg, sc, Q2D (2 mg/week HED)
Bile duct ligation induced PBC & PSC mice
■ Saline Vehicle
■ BLM Vehicle
Bleomycin induced IPF mice
■ HM15211 141 μg/kg, sc, Q2D (4 mg/week HED)
■ HM15211 211 μg/kg, sc, Q2D (6 mg/week HED)
■ Pirfenidone 300 mg/kg, po, QD (2,400 mg/day HED)
Elastase induced COPD mice
■ Normal Vehicle
■ COPD Vehicle
■ Roflumilast 48 mg/day HED
■ HM15211 6 mg/week HED
0
5 0
1 0 0
1 5 0
2 0 0
2 5 0
***
#
0 .0
1 .5
2 .0
2 .5
3 .0
***
*
**
*
0
3
4
5
***
****
*
Fibrosis
Score
Alveolar MLI (Mean Linear Intercept)
Idiopathic Pulmonary Fibrosis (IPF)
Chronic Obstructive Pulmonary Disease (COPD)
15
Diabetes & Obesity: Best-in class potential of Efpeglenatide
• T2DM uncontrolled on diet and exercise
• 7% ≤ HbA1c ≤ 10%
• Stable body weight (< 5kg changes within 3 months prior to screening)
AMPLITUDE_M study design1
• All doses met primary efficacy endpoint
• Comparable GI safety profiles with other GLP-1RAs
• Strong weight loss profile anticipated at a higher dose or
combo with other compound
Robust and Potent glycemic control
by super-agonistic features
30 + 26 weeks treatment period
Screening (3 weeks)
Follow-up(6 weeks)
2mg 2mg
4mg 4mg
6mg 6mg
Placebo Placebo
2mg 4mg
2mg
Homeostatic Feedback Model for Body Weight LossModel Corrected for titration, fitted to the placebo corrected Efpeg and Sema observations
Pla
ce
bo
Co
rre
cte
d c
ha
ng
e in
We
igh
t (%
) 0
-5
-10
-15
-20
0 4 8 12 14 20 24 28 32 36 40 44 48 52
Week
Obesity
TD2M
Efpeglenatide begin on 2mg dose, increasing every 2 weeks until reaching target dose
△H
bA
1C
(% v
s b
ase
line
)
~ 6 months
-0.56-0.71 -0.78
-0.02
-1.45 -1.55
-0.56
-1.06
-1.39-1.59
16
Oncology : Focusing on Novel Assets
Sustaining Novel cancer drug Innovation
through Internal and External expertise
Under Registration
PoziotinibPan-HER inhibitor
Rolontis®
LAPS- GCSF
Chemo-induced Neutropenia
US BLA Review
OraxolOral Paclitaxel +
Encequidar
Metastatic Breast Cancer
US NDA Priority Review
Programs Under Development
EGFR/HER2 Exon20 NSCLCNDA Submission Anticipated
BelvarafenibPan-RAF inhibitor
Solid TumorsPhase 1
HM43239FLT3/SYK dual inhibitor
Acute Myeloid LeukemiaPhase 1/2
FLX 475CCR4 antagonist
HM97662EZH1/2 dual inhibitor
Solid TumorsPhase 1/2
Multiple IndicationsPreclinical
Open for partnership
Open for partnership
17
Oncology : FLT3-mutated AML
1Note: ASH2020 Presented
2021
1Q 2Q 3Q 4Q
160mg
Expansion
ASCO
Data Present
200mg
Expansion
MTD
Finalization
Phase 1/2 Study Design: FLT3 mutated or wild-type AML
Dose Escalation Dose Expansion
40mg
60mg
80mg
120mg
TBD
Expansion
Expansion
160mg
20mg
Ongoing
Doubling
(no DLT/MT)
Expand when
CR/PR observed
Ongoing
Expansion Ongoing
• Phase 1/2 Study is actively ongoing (US/KR)
• US ODD designated for AML (Oct 2018)
FLT3 / SYK dual inhibition shown promising
clinical signals in patients with FLT3 AML
Ongoing
Results1 Case 1 (F, 67) Case 2 (M, 60)
Mutation FLT3-TKD (Gilteritinib-Failed) Wild-type (Salvage-Failed)
Response CR (BM blast 10% → 1%) CRi (BM blast 11.2% → 0.4%)
Status Received ASCT after Cycle 3 Cycle 10 (Ongoing)
Vehicle Gilteritinib 30mpk HM43239 30mpk
Days after Treatment
Tu
mo
r V
olu
me
(m
m3)
Antitumor Activity in MOLM-14-F691L
HM43239
Bone Marrow Stromal CellPhase 1/2 Case Results (HM43239 80mg QD arm)
18
Bispecific Antibody Platform Technology
Differentiated Bispecific Antibody Program
Program Discovery Preclinical Phase 1
BH2950/IBI315PD-1 / HER2
BH3120PD-L1 / 4-1BB
BH3012PD-L1 / CD47
BH3620Undisclosed Target
Solid Tumor
Solid Tumor
Solid Tumor
Solid & Liquid Tumor
PENTAMBODY Platform Technology
Maximized Therapeutic Synergies
Enhanced Stability and Manufacturability
Safe and Stable Profile in Human
BH3120 (PD-L1 / 4-1BB) Safety and Efficacy In-vivo results
T cell Activity Without Cancer In-vivo Efficacy in B16F10
(B16F10: Melanoma)
IL8 (
pg/m
L)
Concentration (nM)
Tum
or
Volu
me (
mm
3)
Days after tumor inoculation
BH3120
• T-cell activation only with the presence of cancer cells
• Significantly improved liver toxicity profile compared to Urelumab
• Shown promising efficacy in solid tumor cell lines
BH3120
19
Rare Disease
The True Innovation should
Embrace patients with rare disease
Lysosomal Storage
Diseases
Long-acting Subcutaneous
Enzyme Replacement
Therapy
Short Bowel Syndrome (SBS)
(3-4 per million)
Monthly GLP-2
Orphan Drug Designation
(ODD) in US & EU
(Jun. 2020)
Congenital Hyperinsulinism (CHI)
(20-40 per million)
Weekly Glucagon
Orphan Drug Designation
(ODD) in US & EU
(Jun. 2020)
20
Short Bowel Syndrome: LAPSGLP-2
• Potent intestinotrophic action of LAPSGLP-2 analog
• The first “Once-a-Month’ treatment option
• Ready-to-inject with soluble formulation
‘Once-a-Month’ injection
“Medical and Quality of Life benefit”
Clinical trial Status
2020 2030 2020 2030 2020 2030
US EU JP
1,000
300 0
>4,000
>2,000>1,000
Estimated number of treated SBS patients across major markets
0
2 0 0 0
4 0 0 0
6 0 0 0
8 0 0 0
1 0 0 0 0
Co
nc
en
tra
tio
n (
ng
/ml)
D-1 D
1
D2
D3
D4
D5
D6
D7
D1
0
D1
7
D3
0
D 8
C o h o r t 4
C o h o r t 3
C o h o r t 2
C o h o r t 1
C o h o r t 5
D4
4
D-1 D-5 D-10 D-17 D-30 D-44
SAD Pharmacokinetic Profile
Phase 1 (SAD, Healthy subject)
High unmet medical needs for patients suffering from SBS
ODD grant in US and EU, RPD grant in US (Jun. 2020)
Phase 2 IND Submitted in US at QM regimen (Dec. 2020) 21
COLLABORATION
22
History of Global Collaborations with partners
“The Way to Sustain Innovation and Growth”
2019
AmosartanAmlodipine+Losartan
EflapegrastimLong acting GCSF analog
RovelitoIrbesartan+Atorvastatin
PoziotinibPan-HER inhibitor
Anti-PD-1/HER2
Bi-specific antibodyTargeted Immuno-Oncology
Orascovery
Platform TechOral Paclitaxel / Irinotecan
2009 2012 2014 2016
2011 2013 2015 2017
RosuzetRosuvastatin
+Ezetimibe
FLX475CCR4 inhibitor,
Immuno-Oncology
New Antibody
SequenceImmuno-Oncology
2018
HyalrheumaHyaluronate
BelvarafenibRAF inhibitor
2020
EfinopegdutideWeekly GLP/GCG
NASH
23
Value-added Programs
• Sustained growth in Korea with core value-added products
• Launching 2~3 products annually
• Seeking partners for emerging markets
Top value-added products
*IMD (Incrementally Modified Drug); **FDC (Fixed Dose Combination)
(bn KRW, *Non-consolidated)
Domestic business growth
2019
597.6
2018
551.8
2017
578.7
2016
687.8702.6
795.0
675.4
863.6
Korea
Total
2020
697.0
870.0Hanmi
24
HANMI OUTLOOK
25
Potential news flows in 2021
“We are committed to deliver our innovation from Science to Patients”26