LOTUS PHARMACEUTICAL THE PREFERRED GLOBAL ONCOLOGY PARTNER April 2019
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LOTUS PHARMACEUTICAL
THE PREFERRED GLOBAL ONCOLOGY PARTNER
April 2019
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
3
1 Company Overview
2 1Q2019 Financial Results and Operational Highlights
3 Profitable Growth Strategy
TABLE OF CONTENTS
4 2019 Outlook
COMPANY OVERVIEW
4
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
LET THE NUMBERS SPEAK 6
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
PRE-ALVOGEN 2016 2017 2018 3M2019
Global Export
Domestic
APAC
Geography Contribution
A FAST GROWING SPECIALTY PHARMACEUTICAL POWERHOUSE WITH GLOBAL REACH
7
• Comprehensive global reach through
Direct Channels, AlvogenInfrastructure and Licensing Network
• 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
2018FY FINANCIAL RESULTS AND
OPERATIONAL HIGHLIGHTS
8
HEALTHY CASHFLOW AND EXPANDING PROFIT 9
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 1Q2019
-544
161
-111
65 1
24 2
87
-600
-400
-200
0
200
400
2014 2015 2016 2017 2018 1Q2019
50% 58% 56% 48%
49%
49%
-19%8% 4% 8% 7% 20%
-40%
-20%
0%
20%
40%
60%
80%
GM OPM
Cashflow (NT$mn)
-920
1386 14251197 1147
242
-2000
-1000
0
1000
2000
2014 2015 2016 2017 2018 1Q2019
Cash Generated From Operations Before Interest And Taxes
KEY BUSINESS EXECUTIONS IN FY2018 AND 3M2019
10
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
• Received the approval of Ulipristal, the
first generic of EsmyaTM, 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$11m in 2019) to upgrade
Nantou site to increase its global
competitive edge as the oral
oncology and special dosage hub
Clearly the preferred partner globally
Best Portfolio
Increasing amount of
successful global launches
based on own R&D
Best Quality
Increasing investment in Nantou site
PROFITABLE GROWTH STRATEGY
11
MARKET TRENDS
• Major changes with Chinese FDA have eventually led to rising awareness in data integrity, quality and the birth of group
purchasing policy that created industry consolidation
• Japan aims to have 80% generics penetration by 2021
• Compliance and innovation encouraged by Korea authorities
• Market access remains challenging across the region with fierce local competition
• Biosimilars a significant opportunity
REGIONALLY, WE WILL CONTINUE TO INVEST IN GROWTH OPPORTUNITIES
12
Thailand
Vietnam
Taiwan
Indonesia
Korea
India
Japan
China
2018E APAC Pharmaceutical Market Size ($bn)‘14-’18 CAGR
12%
1%
8%
5%
10%
4%
14%
5% Source: IQVIA 2018 Dec
GLOBALLY, ONLY VERY FEW SELECTED CATEGORIES WILL GROW - AND WE ARE THERE
13
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
To be launched in 2018 - 2025
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
1 MethotrexateChemo
癌症US: 340
2 LenalidomideMultiple Myeloma
血癌US: 7,000
3 Vinorelbine
Breast cancer and
NSCLC
乳癌與非小細胞肺癌
EU: 130
4 LP650GIST; inhibitor
腸胃道間質腫瘤Global: 1000
5 LP173
Late stage onco for
soft tissues sarcoma
and renal cell
carcinoma
腎癌、上皮細胞癌、軟組織肉瘤（皆非一線）
Global: 800
WELL TARGETED ONCOLOGY PORTOFLIO FUELS GROWTH FOR VISION 2025
14
Focus on high value innovation for patients and customers
Settled in US and launched in selected markets
NO BE
200mg
400mg
Out-licensing scope continues to expand
To be launched in 2018 - 2025
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
6 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
7Enzalutamide
softgel & tablet
Castration-resistant
prostate cancer
去勢抗性的轉移性前列腺癌
Global: 3000
8 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
9 LP664Multiple Myeloma
血癌Global: 2000
WELL TARGETED ONCOLOGY PORTOFLIO FUELS GROWTH FOR VISION 2025
15
Focus on high value innovation for patients and customers
Taiwan dossier ready
To be launched in 2018 - 2021
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
1 Budesonide ER GI 結腸潰瘍 US: 200
2 Ulipristal Women health
女性保健US: FTF
3 LP179Women health
女性保健Global: 300
4LP654
softgel
IPF
特發性肺纖維化Global: 1000
5AK-R309
(FTF)
OAB
膀胱過動症Korea: 24
6 AK-R216Type II diabetes
第二類糖尿病Korea: 11
7 AK-R217Type II diabetes
第二類糖尿病Korea: 67
8 AK-R218CVS
心血管Korea: 26
NON-ONCOLOGY SPECIALTY PIPELINE ADDS VALUE AS FAST FOLLOWER FOR VISION 2025
16
Focus on high value innovation for patients and customers
PIV; non-infringement, CRL
WE CONTINUE TO BUILD THE LOTUS VALUE PATH 17
Korea –Gongju and Hyangnam Plant
Taiwan –Nantou Plant
• Tablets
• Coated tablets
• Hard capsules
• Powders, granules
• Tablets
• Coated tablets
• Softgel capsules
• Hard capsules
KGMP compliant
• Inspected by US FDA,
EU EMA, Japan
PMDA and TFDA
PIC/S with no critical
observations
1 3
2 4
5
REVENUE GROWTH
QUALITY IMPROVEMENT
STRENGTHEN ORGANIZATION
PIPELINE EXECUTION
OPERATIONAL EXCELLENCE
• Sharpen competitiveness to handle supply chain
and operation complexity driven by exponential
growth from global exports
• Upgrade hardware, people and systems to
maintain high service level
• Continue to ensure compliance across global
quality standards
Our 5Y CAPEX plan
2019 OUTLOOK
18
FROM BUILDING KEY FRANCHINSES IN THE REGION TO GROWING THEM WORLDWIDE
19
GEFITINIB & VINORELBINE
20
1 HIGHEST QUALITY
2 BEST IN CLASS CUSTOMER SERVICE
3 TARGETED PORTFOLIO
4 HIGH OPERTIONAL EFFICIENCY
5 ONLY THE BEST PEOPLE
The foundation for vision 2020
FUEL FOR GROWTH
We will continue to set a new
standard for our industry outlined
in a simple strategic model
21
APPENDIX
1Q2019 IS 22
TOP15 FOR 1Q2019 23
INN Indication YTD (NT$mn) YoY (%) Remarks
1 Buprenorphine/Naloxone film OUD 戒癮 557.5 - 2019 New launch
2 Goserelin (Zoladex) Breast cancer 乳癌 144.8 11%Exclusive marketing alliance with AstraZeneca
KR; launched Oct’16
3 Rosuvastatin/EzetimibeCardiovascular
131.0 23% Dosage improved to 1/day降血脂與膽固醇
4 Desogestrel/EE (Mercilon)Oral contraceptive
口服避孕藥97.6 40% Acquired from Bayer; launched in May’16
5 Calcium Polystyrene Sulfonate Nephrology 腎臟病 91.4 14%
6 Seroquel (Quetiapine) Schizophrenia 精神分裂症 77.8 14%Exclusive marketing alliance with AstraZeneca
KR; launched Oct’15
7 Ibandronate D3 Osteoporosis 骨質疏鬆症 65.1 100%
8 Sarpogrelate Anticoagulant 抗凝血 64.7 -50% FDC; launched in 1Q16
9 Anastrozole (Arimidex) Oncology 癌症 53.0 12%Exclusive marketing alliance with AstraZeneca
KR; launched 4Q’16
10 Raloxifene (Evista) Osteoporosis 骨質疏鬆症 52.4 - 2019 New Launch
11 Bicalutamide Prostate cancer 攝護腺癌 51.9 1%Exclusive marketing alliance with AstraZeneca
KR; launched Oct’16
12 Phentermine Anti-obesity 減肥 51.8 11%
13 Phendimetrazine Anti-obesity 減肥 34.2 -11%Acquired from Novartis; launched Apr’17;
TW product
14 Zoledronic Acid (Aclasta) Osteoporosis 骨質疏鬆症 29.7 -26% Acquired from Novartis; launched Apr’17;
15 Orlistat Anti-obesity 減肥 26.7 -12%
LEADERSHIP TEAM
JULIA LINREGIONAL MANAGEMENT -REGULATORY DIRECTOR
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