LOTUS PHARMACEUTICAL
THE PREFERRED GLOBAL ONCOLOGY PARTNER
August 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 2Q2019 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 7M2019
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
• 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
1H 2019 FINANCIAL RESULTS AND
OPERATIONAL HIGHLIGHTS
8
P&L COMPARISON 9
1H 2019 NET PROFIT NORMALIZATION 10
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
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
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
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$11m in 2019) to upgrade
Nantou site to increase its global
competitive edge as the oral
oncology and special dosage hub
• Nantou site received “0 observation”
during the latest USFDA inspection
in May, 2019
Clearly the preferred partner globally
Best Portfolio
Increasing amount of
successful global launches
based on own R&D
Best Quality
Increasing investment in Nantou site
PROFITABLE GROWTH STRATEGY
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MARKET TRENDS
• Major changes with Chinese FDA have eventually led to rising awareness in data integrity, quality and the birth of group
purchasing policy that created industry consolidation
• Japan aims to have 80% generics penetration by 2021
• Compliance and innovation encouraged by Korea authorities
• Market access remains challenging across the region with fierce local competition
• Biosimilars a significant opportunity
REGIONALLY, WE WILL CONTINUE TO INVEST IN GROWTH OPPORTUNITIES
16
Thailand
Vietnam
Taiwan
Indonesia
Korea
India
Japan
China
2018E APAC Pharmaceutical Market Size ($bn)‘14-’18 CAGR
12%
1%
8%
5%
10%
4%
14%
5% Source: IQVIA 2018 Dec
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
To be launched in 2019 - 2025
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
1 MethotrexateChemo
癌症US: 170
2 LenalidomideMultiple Myeloma
血癌US: 7,000
3 SunitinibGIST; inhibitor
腸胃道間質腫瘤Global: 1000
4 LP173
Late stage onco for
soft tissues sarcoma
and renal cell
carcinoma
腎癌、上皮細胞癌、軟組織肉瘤(皆非一線)
Global: 800
WELL TARGETED ONCOLOGY PORTOFLIO FUELS GROWTH FOR VISION 2025
18
Focus on high value innovation for patients and customers
Settled in US and launched in selected markets
200mg
400mg
Out-licensing scope continues to expand
To be launched in 2019 - 2025
Generic Name Indication IQVIA market size (US$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
To be launched in 2019 – 2022
Generic Name Indication IQVIA market size (US$mn) Formulation BE & CT Submission Approval
1 Budesonide ER GI 結腸潰瘍 US: 200
2 Ulipristal Women health
女性保健US: FTF
3 LP179Women health
女性保健Global: 300
4LP654
softgel
IPF
特發性肺纖維化Global: 1000
5AK-R309
(FTF)
OAB
膀胱過動症Korea: 24
6 AK-R216Type II diabetes
第二類糖尿病Korea: 11
7 AK-R217Type II diabetes
第二類糖尿病Korea: 67
8 AK-R218CVS
心血管Korea: 26
9Varenicline SR
1.5mg (IMD)
Smoking Cessation
戒菸First in Korea
NON-ONCOLOGY SPECIALTY PIPELINE ADDS VALUE AS FAST FOLLOWER FOR VISION 2025
20
Focus on high value innovation for patients and customers
PIV; non-infringement, CRL
WE CONTINUE TO BUILD THE LOTUS VALUE PATH 21
Korea –Gongju and Hyangnam Plant
Taiwan –Nantou Plant
• Tablets
• Coated tablets
• Hard capsules
• Powders, granules
• Tablets
• Coated tablets
• Softgel capsules
• Hard capsules
KGMP compliant
• Inspected by US FDA,
EU EMA, Japan
PMDA and TFDA
PIC/S with no critical
observations
1 3
2 4
5
REVENUE GROWTH
QUALITY IMPROVEMENT
STRENGTHEN ORGANIZATION
PIPELINE EXECUTION
OPERATIONAL EXCELLENCE
• Sharpen competitiveness to handle supply chain
and operation complexity driven by exponential
growth from global exports
• Upgrade hardware, people and systems to
maintain high service level
• Continue to ensure compliance across global
quality standards
Our 5Y CAPEX plan
2019 OUTLOOK
22
OUR COMMITMENT 23
• Our mission is to be a PREFERRED GLOBAL PARTNER in SELECTIVE
oral oncology products and specialty generics
• Continue to strengthen portfolio for the existing APAC platform to increase
contribution per sales
• Continue to evaluate INORGANIC OPPORTUNITIES in new, attractive
segments
24
APPENDIX
B/S AS OF JUNE 30TH 2019 25
TOP15 FOR 1H2019 26
INN Indication YTD (NT$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%
LEADERSHIP TEAM
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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