Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted...

20
35 th Annual J.P. Morgan Healthcare Conference Gwan Sun Lee President & CEO

Transcript of Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted...

Page 1: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

35th Annual J.P. Morgan Healthcare Conference

Gwan Sun Lee President & CEO

Page 2: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

This presentation contains forward-looking statements with respect to the financial

condition, results of operations and businesses of Hanmi Pharmaceutical Company.

By their nature, forward- looking statements and forecasts involve r isk and

uncertainty because they relate to events and depend on circumstances that will

occur in the future. There are a number of factors that could cause actual results

and developments to differ materially from that expressed or implied by these

forward-looking statements. These factors include, among other things, the loss or

expirat ion of patents, market ing exclusivi ty or trade marks; exchange rate

fluctuations; the risk that R&D will not yield new products that achieve commercial

success; the impact of competition, price controls and price reductions; taxation

risks; the risk of substantial product liability claims; the impact of any failure by

third parties to supply materials or services; the risk of delay to new product

launches; the difficulties of obtaining and maintaining governmental approvals for

products; the risk of failure to observe ongoing regulatory oversight; the risk that

new products do not perform as we expect; and the risk of environmental liabilities.

2

Page 3: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Acquisition

in June 2016

3

Page 4: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

PAST PRESENT FUTURE

Strong cash flow from

traditional pharma business

through our own value-

added products & generics

Heavy investment in

innovation R&D from the

early 2000s

Robust pipeline from

in-house R&D as well as

open innovation

Leading in our core

businesses in Korea &

China

Investment in the highest-

potential business

To be a global R&D

powerhouse through

continuous new drug

discovery & development

in core therapeutic areas

To significantly grow

through innovative new

drugs

4

Page 5: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Obesity Oncology Auto-immune Diabetes

5

Page 6: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Obesity

Oncology

Auto-immune

Diabetes

Others

B

B

B

6

Page 7: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Key Features

Redirect immune cells to tumor cells

Natural IgG-like bispecific antibody format

Good stability and high production efficiency

Seeking collaboration opportunities

(PENTAMBODY + Novel target)

7

Next generation bispecific antibody platform technology,

developed by Beijing Hanmi for both immunotherapy & targeted therapy

Tumor cell

Immune cell

P

E

N

T

A M

B

O D

Y

Page 8: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

8

Pentambody applied PD-1/HER2 BsAb

Cell-to-cell association (%) using SK-BR-3 and CHO-PD1 cells by FACS1

1HER2 positive SK-BR-3 stained with CFSE, CHO-PD1 stained with PKH26, Test article 100nM, 30min; 2E (activated hPBMC) : T (HCC827) = 20 : 1, 72hr

Redirect immune cells to tumor cells

Better anti-tumor activity compared to combination

Pentambody applied PD-1/PD-L1 BsAb

Cell cytotoxicity assay using PD-L1 expressed NSCLC cell2

Anti-PD-L1 mAb: IC50 >2,000 pM

Anti-PD-1 mAb: IC50 440 pM

Combination: IC50 50 pM

PD-1/PD-L1 BsAb (BH2941): IC50 10 pM

Page 9: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

9

LAPSCOVERY : Long-Acting Protein/Peptide Discovery

AG

LY

CO

SY

LA

TE

D F

C

AG

LY

CO

SY

LA

TE

D F

C

3 Focus Areas

Obesity Diabetes Rare Diseases

(enzyme)

Seeking new opportunities by expanding indications

8 Programs

5 Clinical programs 3 Non-clinical programs

• LAPS GCSF

• LAPS hGH

• LAPS Insulin115

• LAPS Exd4

• LAPS GLP/GCG

• LAPS Insulin combo

• Diabetes/Obesity Program

• Rare Disease Program

Page 10: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

LAPS is the best long-acting solution for ERT

PK extension with best-in-class

potential

(Subcutaneous self administration)

Higher exposure & tissue delivery

10

Page 11: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

HM95573, pan-RAF inhibitor

An orally active, selective and potent next generation

RAF inhibitor with anti-tumor effect on BRAF mutant

as well as RAS mutant cancer

A variety of science-driven combinations will be assessed, as well as monotherapy

Exclusive License Agreement with Genentech (Sep 2016)

Upfront : USD 80M / Milestones : up to USD 830M / Tiered double-digit royalty

11

Page 12: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

3rd generation EGFR targeted therapy

NDA approved and commercialized in Korea in

May 2016

Boehringer Ingelheim returned

development and global commercial rights

of olmutinib to Hanmi in Sep 2016

In China, IND submitted to CFDA by our

partner, Zai Lab

Seeking opportunities for global

collaboration

olmutinib Quantum Project

A portfolio of long-acting diabetes treatments :

1) efpeglenatide, 2) weekly insulin, and 3)

efpeglenatide/weekly insulin combo

Sanofi is responsible for the development

and commercialization of efpeglenatide

Sanofi returned its rights to Hanmi weekly

insulin in Dec 2016

Hanmi will continue its efforts, in solid

cooperation with Sanofi, for the

development and commercialization of

efpeglenatide/weekly insulin combo

12

Page 13: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Korea China

Emerging market US / Europe

Sustain double-digit growth through

new value-added programs with data

exclusivity

Maintain a profitable performance with

Beijing Hanmi’s key brands

Seek synergies with JVM

Expand market access and enhance

sales for value-added programs

through partnership & collaboration

Continue our effort to develop and

commercialize Hanmi’s innovative

R&D pipeline with partners

13

Page 14: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Double-digit

Rx Growth in 2016

CAPEX Completion of

New Plant

at Paltan site

15.3%* 8.8% 1+3

New Products

Launch 1 NCE & 3 value-

added products

2B

max.

10B

*Ubist, YOY growth rate of accumulated Rx until Nov 2016

Driving growth and delivering profits with new products

Capacity expansion for future global business

14

Page 15: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Launching 2~3 products annually in the domestic market

8 new products under development

Seeking partners for emerging market business

‘Rosuzet® ’ Collaboration with MSD for 23 countries

*Incrementally Modified Drug **Fixed Dose Combination 15

Page 16: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Performance R&D Expand Local

Partnerships

Sustain No.1 position in

pediatric market

Maintain profits from key

brands

Business diversification

through JVM’s products

Focus on innovative R&D

for global development

strategy

160 R&D staffs

New platform technology

“Pentambody”

Fast & successful

development in collaboration

with local partners with in-

depth understanding of

Chinese market

16

Page 17: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Hanmi Science acquired JVM in Jun 2016

Global No.1 company making automated system for hospitals & pharmacies

JVM’s competitive technology to create new value to Hanmi group

Sales and distribution by Online Pharm

R&D & manufacture by JVM

Beijing Hanmi will act as the operation

hub for JVM Chinese business

Build new business structure to

maximize synergistic effect

17

Page 18: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

To be more efficient and effective

18

Page 19: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

19

Page 20: Gwan Sun Lee · 2017-01-11 · PK extension with best-in-class ... 11 3rd generation EGFR targeted therapy ... hub for JVM Chinese business Build new business structure to maximize

Thank you