se chang kwon

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)





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



■ 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

Thank you

Contact for inquiries

JiyoonKim (IR manager)

[email protected]

27

se chang kwon

Documents