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LOTUS PHARMACEUTICAL THE PREFERRED GLOBAL ONCOLOGY PARTNER August 2019
Transcript
Page 1: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

LOTUS PHARMACEUTICAL

THE PREFERRED GLOBAL ONCOLOGY PARTNER

August 2019

Page 2: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

Except for historical information contained herein, the matters set forth in this

presentation are forward looking statements that are subject to risks and

uncertainties that could cause actual results to differ materially. These forward

looking statements are not based on historical facts but rather on

management’s expectations regarding future growth, results of operations,

performance, future capital and other expenditures, competitive advantages,

business prospects and opportunities. Statements in this presentation about

our future plans and intentions, results, level of activities, performance, goals

or achievements or other future events constitute forward looking statements.

Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”,

“could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the

negative or other variations of statements reflect management’s current

beliefs and assumptions and are based on the information currently available

to our management. Investors are cautioned not to place undue reliance

on these forward looking statements, which are made as of the date of

this presentation and we assume no obligation to update or revise any

forward looking statements.

Safe Harbor

Statement

Page 3: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

3

1 Company Overview

2 2Q2019 Financial Results and Operational Highlights

3 Profitable Growth Strategy

TABLE OF CONTENTS

4 2019 Outlook

Page 4: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

COMPANY OVERVIEW

4

Page 5: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

TANGIBLE TRANSFORMATION FROM A LOCAL PLAYER TO GLOBAL CONTENDER

5

1966-2014

• A local player servicing

mostly Taiwan domestic

market with “first in Taiwan”

generics

• Established formulation

skills across multiple drug

delivery systems

• Listed on TPEX since 2010

• Reshape portfolio to build key

franchises in APAC direct

markets

• Nantou (Taiwan) R&D and

manufacturing site inspected

by US FDA, EU EMA, Japan

PMDA and TFDA PIC/S

• Became a Taiwan Market

Biotechnology and Medical

Care Index stock in July, 2017

• Focused portfolio surrounding

oral oncology, hormonal and

special dosage forms

• Balanced growth from internal

and external opportunities

• Became a TPEX 50 Index

stock in April, 2018

LOTUS BEFORE ALVOGEN

2014-2017

POST MERGER INTEGRATION

2018-2025

A STRONG GLOBAL CONTENDER

Page 6: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

LET THE NUMBERS SPEAK 6

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

PRE-ALVOGEN 2016 2017 2018 7M2019

Global Export

Domestic

APAC

Geography Contribution

Page 7: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

A FAST GROWING SPECIALTY PHARMACEUTICAL POWERHOUSE WITH GLOBAL REACH

7

• Comprehensive global reach through

Direct Channels, AlvogenInfrastructure and Licensing Network

• 70+ B2B contracts signed with leading global pharmaceuticals to penetrate into literally every market

• 1000+ Employees

• 3 Manufacturing and R&D Centers

• 300+ Marketed products

• Focused on 5 therapeutic areas

including Oncology, Women health, Cardiovascular, Central Nervous System, and GI

Lotus Facts

Page 8: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

1H 2019 FINANCIAL RESULTS AND

OPERATIONAL HIGHLIGHTS

8

Page 9: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

P&L COMPARISON 9

Page 10: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

1H 2019 NET PROFIT NORMALIZATION 10

Page 11: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

HEALTHY CASHFLOW AND EXPANDING PROFIT 11

Revenue (NT$mn) Gross and Operating Margin Net Profit (NT$mn)

2310

5522 59026424 6429

0

2000

4000

6000

8000

2014 2015 2016 2017 2018 1H2019

-544

161

-111

65 1

24 3

39

-600

-400

-200

0

200

400

2014 2015 2016 2017 2018 1H2019

50% 58% 56%48%

49%

49%

-19%8% 4% 8% 7%

14%

-40%

-20%

0%

20%

40%

60%

80%

2014 2015 2016 2017 2018 1H2019

GM OPM

Cashflow (NT$mn)

-920

1386 14251197 1147

425

-2000

-1000

0

1000

2000

2014 2015 2016 2017 2018 1H2019

Cash Generated From Operations Before Interest And Taxes

Page 12: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

FROM LOCAL TO GLOBAL REACH

TRANSFORMATION from a single market player to a full scale global supplier of oncology and specialty drugs

• Building a strong infrastructure for global partnerships and product launches

• Focusing on oncology and complex generics

• Investing in pipeline, production facility and people

Page 13: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

LONG TERM FUNDING AND RETURN PROFILE 13

Operating Income Margin

EBT/Share Capital

Net Debt/LTM EBITDA

<3.5XClose to International Peers

Growth Company Profile

Page 14: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

KEY BUSINESS EXECUTIONS IN 7M2019 14

Best Service

• Strong supply chain enabled 98%

fulfillment of customer orders in the

requested time with requested

quantity during the period

• Strong global collaboration

momentum for oral oncology and

hormonal products with Sandoz,

Zentiva, Accord, Stada and

Consilient for Lenalidomide,

Gefitinib, Vinorelbine and LP149

• Launched Buprenorphine/Naloxone

sublingual film, generic of Suboxone film,

as first wave generics in the US

• Launched Lenalidomide, the first generic

of RevlimidTM, in Europe

• Launched Gefitinib in Europe through a

Day-1 launch

• Launched the first generic of Navelbine,

Vinorelbine softgel capsule, in Europe

• Nantou site inspected by US FDA,

EU EMA, Japan PMDA and TFDA

PIC/S with no critical observations

• Kicked off a 5Y CAPEX plan

(US$11m in 2019) to upgrade

Nantou site to increase its global

competitive edge as the oral

oncology and special dosage hub

• Nantou site received “0 observation”

during the latest USFDA inspection

in May, 2019

Clearly the preferred partner globally

Best Portfolio

Increasing amount of

successful global launches

based on own R&D

Best Quality

Increasing investment in Nantou site

Page 15: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

PROFITABLE GROWTH STRATEGY

15

Page 16: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

MARKET TRENDS

• Major changes with Chinese FDA have eventually led to rising awareness in data integrity, quality and the birth of group

purchasing policy that created industry consolidation

• Japan aims to have 80% generics penetration by 2021

• Compliance and innovation encouraged by Korea authorities

• Market access remains challenging across the region with fierce local competition

• Biosimilars a significant opportunity

REGIONALLY, WE WILL CONTINUE TO INVEST IN GROWTH OPPORTUNITIES

16

Thailand

Vietnam

Taiwan

Indonesia

Korea

India

Japan

China

2018E APAC Pharmaceutical Market Size ($bn)‘14-’18 CAGR

12%

1%

8%

5%

10%

4%

14%

5% Source: IQVIA 2018 Dec

Page 17: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

GLOBALLY, ONLY VERY FEW SELECTED CATEGORIES WILL GROW - AND WE ARE THERE

17

Positioned to be a specialty, fast follower

Launch-by-type evolution

According to IQVIA, along withincreasing number of launches,product types continue to shift tospecialty, orphan, oncology andbiologics products

2004-2008 2019-2023

Source: IQVIA 2018 Dec

Quality

Price

Service Level

TRADITIONAL GENERIC PLAYERS ARE HERE

Mass & Vertical R&D/MFG Investment WE ARE HERE

Page 18: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

To be launched in 2019 - 2025

Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval

1 MethotrexateChemo

癌症US: 170

2 LenalidomideMultiple Myeloma

血癌US: 7,000

3 SunitinibGIST; inhibitor

腸胃道間質腫瘤Global: 1000

4 LP173

Late stage onco for

soft tissues sarcoma

and renal cell

carcinoma

腎癌、上皮細胞癌、軟組織肉瘤(皆非一線)

Global: 800

WELL TARGETED ONCOLOGY PORTOFLIO FUELS GROWTH FOR VISION 2025

18

Focus on high value innovation for patients and customers

Settled in US and launched in selected markets

200mg

400mg

Out-licensing scope continues to expand

Page 19: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

To be launched in 2019 - 2025

Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval

5 LP337

Late stage

hepatocellular

carcinoma, renal

cell carcinoma,

thyroid carcinoma

晚期肝細胞癌、晚期腎癌、分化型甲狀腺癌(皆非一線)

Global: 800

6Enzalutamide

softgel & tablet

Castration-resistant

prostate cancer

去勢抗性的轉移性前列腺癌

Global: 3000

7 LP661

Ph+ CML in chronic

phase

治療慢性期及費城染色體陽性的慢性骨髓性白血病成年患者

Global: 2000

8 LP664Multiple Myeloma

血癌Global: 2000

WELL TARGETED ONCOLOGY PORTOFLIO FUELS GROWTH FOR VISION 2025

19

Focus on high value innovation for patients and customers

Taiwan dossier ready

Page 20: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

To be launched in 2019 – 2022

Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval

1 Budesonide ER GI 結腸潰瘍 US: 200

2 Ulipristal Women health

女性保健US: FTF

3 LP179Women health

女性保健Global: 300

4LP654

softgel

IPF

特發性肺纖維化Global: 1000

5AK-R309

(FTF)

OAB

膀胱過動症Korea: 24

6 AK-R216Type II diabetes

第二類糖尿病Korea: 11

7 AK-R217Type II diabetes

第二類糖尿病Korea: 67

8 AK-R218CVS

心血管Korea: 26

9Varenicline SR

1.5mg (IMD)

Smoking Cessation

戒菸First in Korea

NON-ONCOLOGY SPECIALTY PIPELINE ADDS VALUE AS FAST FOLLOWER FOR VISION 2025

20

Focus on high value innovation for patients and customers

PIV; non-infringement, CRL

Page 21: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

WE CONTINUE TO BUILD THE LOTUS VALUE PATH 21

Korea –Gongju and Hyangnam Plant

Taiwan –Nantou Plant

• Tablets

• Coated tablets

• Hard capsules

• Powders, granules

• Tablets

• Coated tablets

• Softgel capsules

• Hard capsules

KGMP compliant

• Inspected by US FDA,

EU EMA, Japan

PMDA and TFDA

PIC/S with no critical

observations

1 3

2 4

5

REVENUE GROWTH

QUALITY IMPROVEMENT

STRENGTHEN ORGANIZATION

PIPELINE EXECUTION

OPERATIONAL EXCELLENCE

• Sharpen competitiveness to handle supply chain

and operation complexity driven by exponential

growth from global exports

• Upgrade hardware, people and systems to

maintain high service level

• Continue to ensure compliance across global

quality standards

Our 5Y CAPEX plan

Page 22: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

2019 OUTLOOK

22

Page 23: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

OUR COMMITMENT 23

• Our mission is to be a PREFERRED GLOBAL PARTNER in SELECTIVE

oral oncology products and specialty generics

• Continue to strengthen portfolio for the existing APAC platform to increase

contribution per sales

• Continue to evaluate INORGANIC OPPORTUNITIES in new, attractive

segments

Page 24: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

24

APPENDIX

Page 25: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

B/S AS OF JUNE 30TH 2019 25

Page 26: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

TOP15 FOR 1H2019 26

INN Indication YTD (NT$mn) YoY (%) Remarks

1 Buprenorphine/Naloxone film OUD 戒癮 787.1 - 2019 New launch

2 Goserelin (Zoladex) Breast cancer 乳癌 281.4 3%Exclusive marketing alliance with AstraZeneca KR;

launched Oct’16

3 Rosuvastatin/EzetimibeCardiovascular

256.8 -2% Dosage improved to 1/day降血脂與膽固醇

4 Calcium Polystyrene Sulfonate Nephrology 腎臟病 174.1 9%

5 Seroquel (Quetiapine) Schizophrenia 精神分裂症 165.1 15%Exclusive marketing alliance with AstraZeneca KR;

launched Oct’15

6 Sarpogrelate Anticoagulant 抗凝血 154.9 -39% FDC; launched in 1Q16; facing generic competition

7 Desogestrel/EE (Mercilon)Oral contraceptive

口服避孕藥124.4 -6%

Acquired from Bayer; launched in May’16; changing

distributor in 2Q’19

8 Phentermine Anti-obesity 減肥 118.8 18%

9 Anastrozole (Arimidex) Oncology 癌症 107.1 12%Exclusive marketing alliance with AstraZeneca KR;

launched 4Q’16

10 Bicalutamide Prostate cancer 攝護腺癌 100.4 -4%Exclusive marketing alliance with AstraZeneca KR;

launched Oct’16

11 Raloxifene (Evista) Osteoporosis 骨質疏鬆症 98.7 - 2019 New Launch

12 Lenalidomide MM 多發性骨髓瘤 88.8 - 2019 New Launch, global

13 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 71.3 -12% Acquired from Novartis; launched Apr’17

14 Phendimetrazine Anti-obesity 減肥 70.3 -14%

15 Trazodone Anti-depression 抗憂鬱 60.0 +17%

Page 27: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

LEADERSHIP TEAM

Page 28: LOTUS PHARMACEUTICAL · franchises in APAC direct markets • Nantou (Taiwan) R&D and manufacturing site inspected by US FDA, EU EMA, Japan PMDA and TFDA PIC/S • Became a Taiwan

28

1 HIGHEST QUALITY

2 BEST IN CLASS CUSTOMER SERVICE

3 TARGETED PORTFOLIO

4 HIGH OPERTIONAL EFFICIENCY

5 ONLY THE BEST PEOPLE

The foundation for vision 2020

FUEL FOR GROWTH

We will continue to set a new

standard for our industry outlined

in a simple strategic model


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