Formosa Laboratories Ltd.

MasterLink Securities Investment Forum

TWSE 4746

1

Disclaimer

This material has been prepared by Formosa Laboratories Inc. (“Formosalab”).

Any opinions expressed in this material are subject to change without notice as a result of using

different assumptions. Formosalab is under no obligation to update or keep current the information

contained herein. The information contained in this presentation is Formosalab’s confidential

information.

Any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it is

prohibited and may be unlawful.

No representation or warranty, express or implied, is or will be made in or in relation to, and no

responsibility or liability is or will be accepted by the Company as to, the accuracy or completeness

of this material and any liability therefore is hereby expressly disclaimed.

Statements made in this material include forward-looking statements, which include, without

limitation, statements about the issues, plans and expectations of Formosalab. Without limiting the

foregoing, statements including the words “believes”, “anticipates”, “plans”, “expects” and similar

expressions are also forward-looking statements. Forward-looking statements reflect, among other

things, management’s plans and objectives for future operations, current views with respect to future

events and future economic performances and projections of various financial items. These forwardlooking

statements involve known and unknown risks, uncertaint ies and other factors which

may cause actual results to differ materially from those implied by such forward-looking

statements.2

3

Agenda

� Introduction

� Business Overview

� Business Outlook

� Investment List

Introduction

4

• Established on Dec. 29, 1995

• Capital：NT$ 851 million

• Employee headcount：651

• Area：45,508 m2

• Business scope ：APIs (37 US DMFs, 14 EU DMFs, 7 JMFs)

UV filter (One of top three makers)

Contract API RD & Manufacturing

• Inspected by Taiwan TFDA, US FDA, Japan PMDA, German BGV,

EU EDQM and Mexican COFEPRIS

• Persist to maintain international standards and strengthen R&D capability.

• Maintain global leadership of the mainstream products

• Enhance ADC R&D team and facility

• Continue investing on new products development and new drug

developments

7

Business Strategy

Business Overview

7

896 834

981

1,543

1,779 1,730 1,690

1,493

953

818 34% 33%

40%

62%

69%

0%

10%

20%

30%

40%

50%

60%

70%

80%

-

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2011 2012 2013 2014 2015

2011-2015

API UV API%

NT$: M

17

API: Growth Driver

API: Growth Driver

NT$: M

12

66 43 99

546 681

218 191

231

276

381

111 161

178

228

170

107 167

153

108

138

81 35

74

75

127

63 43

63

98

91

5 5

21

20

54

192 122

109

145

87

-

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2011 2012 2013 2014 2015

Others

Antibiotics

CMO

Respiratory Agents

Central Nervous System Agents

Inflammatory

Vit. D Derivatives

Cholesterol and phosphate binder

8

29%

40%48%

21%

23%17%15%

10%11%

5%

2%

8%19%18%

7%3%

3% 4%5% 2% 3%2% 1% 1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2013 2014 2015

China

Africa

Japan

Latin America

Other Asia Region

Mid-East

Taiwan

EU

US

API: main market in US and EU

2015 Performance

1.Cholesterol and Phosphate binder NT$ 681m，YoY + 25%

2.Vit. D Derivatives NT$ 381m，YoY + 38%

3.Inflammatory NT$ 170m，YoY － 25%

4.Respiratory Agents NT$ 127m，YoY + 69%

5.Antibiotics NT$ 54m，YoY +178%

NT$ M 2014 2015YoY

Category Sales % Sales %

UV Filter 953.2 38% 817.6 31% -14.2%

API 1,543.0 62% 1,779.1 69% 15.3%

Total 2,496.2 100% 2,596.7 100% 4.0%

11

2016 Jan Performance

NT$ M 2015 Jan 2016 JanYoY

Category Sales % Sales %

UV Filters 35.0 38% 106.5 31% 204.3%

API 110.0 62% 144.0 69% 30.4%

Total 145.0 100% 250.5 100% 72.8%

12

1.Cholesterol and Phosphate binder NT$ 52m，YoY + 40%

2.Vit. D Derivatives NT$ 41m，YoY + 273%

3.Inflammatory NT$ 25m，YoY + 1259%

4.Respiratory Agents NT$ 6m，YoY - 79%

5.Antibiotics NT$ 0m，YoY - 96%

Business Outlook

13

Products Update

Cholesterol and Phosphate Binders

• Sevelamer Carbonate / Hydrochloride –

� Global market size reached US$ 2bm in the last 4 quarters, annual growth

rate 23%, API demands 550tons. (IMS data)

� EU, Brazil and Turkey markets demonstrate steady growth

� Continuous orders from US client for market launch preparation, aiming to

acquire >50% of market share.

• Colesevelam Hydrochloride -

� Global market size reached US$ 730m in the last 4 quarters, annual growth

rate 9%, API demands 210tons. (IMS data)

� US as major market, US market size US$720m

• Calcium Acetate -

� US market US$ 60m (IMS data)

� Formosa Labs’ clients acquire ~80% of US market share.14

Products Update

Vit. D Derivatives

• Paricalcitol

� Expect a 50% of growth in sales due to ANDA approvals

• Maxacalcitol

� Oxarol is sold only in Japan. Market size of US$140m (IMS data)

� Client is planning to launch on market in late 2015 and expecting to acquire

70% market share of Japan generic drug market.

• Doxercalciferol

� 7 client (ANDA only approved in US market)

� 2 clients will acquire ANDA in 2016 which would account for 20% of growth

• Calcipotriol

� EU client’s new formulation is marketing in Mar., 2016. expect to acquire 10%

of market share in 2016, 20~30% in 2017.

� Korea client launched on market in 2015Q1. expect for 20% increase of

demands.15

Products Update

� Benzonatate (respiratory agent)

� US market launch is expected in 2016Q1. Strict API supplies

� Expect for 30~50% market share

� Steady supply growth in Latin America market.

� Temozolomide (brain tumor)

� Global market reached US 700m is the last 4 quarters. API demands

890kg. Annual growth rate 5% (IMS data)

� US ANDA approved in 2015Q2, European ANDA in 2016Q3

� Registered in China, expect for market launch in 2017Q4

� Expect to have 30% of global market.

16

Products Update

� Balsalazide (inflammatory)

� >80% market share in US market

� Market launch in Korea in 2015

� Indian client is expecting for obtain US ANDA in 2016Q3

� Linezolid (antibiotics)

� Total market size in US, EU and Japan is around US$ 1bm. API demands 6tons

(IMS data)

� One major client who is the top 10 generic pharmaceutical company got UK and

US ANDA in 2015 Q1~Q2 expecting to acquire 10% of market in EU and US.

� Japanese client is the sole provider in JP market.

� UV Filters

� Steady growth in 2016

� New clients for 2 developing products

� Improved GM due to cost control17

Launch Schedule

Product Indication 2015 2016 2017 2018 Total Global

Market(US$ M)

2014 Q4 –

2015 Q3

Calcipotriol

MonohydratePsoriasis 953

Calcium AcetateAnti-

Hyperphosphatemia55

Colesevelam HCl*Lower cholesterol

level735

Sevelamer

Carbonate

Anti-

Hyperphosphatemia2,000

Sevelamer HClAnti-

Hyperphosphatemia

Linezolid antibiotic 1,198

Temozolomide Brain tumor 705

Benzonatate Cough suppressant 65

18

US: EU: JP: RoW:

*2018 launch in China

Rich Pipelines

� Antibody-Drug Conjugates(ADC)

Several new potential ADC candidates

� Products in development (total 18)

anticoagulant 2

anti-tumor 5

CNS agent 1

phosphate binder 3

osteoporosis 3

UV filter 2

potassium binder 1

antibiotic 1

19

Development Timetable

20

Product2018

~2020

2021

~2023

2024

~2026

2027

~2029

Global market

in last 4Q(US$ M)

Anti-coagulant (2) v v 5,114

Anti-tumor (5) v v v 2,777

CNS agent (1) v 878

Phosphate binder (3) v v 5,558

Osteoporosis (3) v v 462

Antibiotic (1) v 16

Total 14,805

CDMO

21

� New lab will be deployed in 2016/3, expect 80% capacity increase

� ADC production line in high potent plant will be ready by 2016 Q2

� 28 projects in development

New drug: 24 items

(7 in NDA 、1 in Phase III、3 in Phase II 、4 in Phase

I、9 in Pre-IND)

Generic drug：4 items

Investment List

22

23

Company Business Scope Time to investInvestment

(NT$ M)

Holding

shares

EirGenix Biosimilar、CDMO 2012 209 13%

Formosa Pharmaceutical New Drug Development 2010 120 100%

TaiRx New Drug Development 2011 55 6.5%

Glory Biotech Fermentation 2011 30 9.9%

Senhwa Biosciences New Drug Development 2012 19 2.9%

TOT Biopharm

Anti-tumor treatment

Development 2015 66 3.0%

Total 499

Investments

Q&A